Senate hearing (117th Congress), DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2022
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[Senate Hearing 117-497]
[From the U.S. Government Publishing Office]
S. Hrg. 117-497
Senate Hearings
Before the Committee on Appropriations
_______________________________________________________________________
Departments of Labor,
Health and Human Services,
and Education, and Related
Agencies Appropriations
Fiscal Year 2022
117th Congress, First Session
H.R. 4502
DEPARTMENT OF EDUCATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
DEPARTMENT OF LABOR
NONDEPARTMENTAL WITNESSES
S. Hrg. 117-497
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2022
=======================================================================
HEARINGS
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED SEVENTEENTH CONGRESS
FIRST SESSION
ON
H.R. 4502
AN ACT MAKING APPROPRIATIONS FOR THE DEPARTMENTS OF LABOR, HEALTH AND
HUMAN SERVICES, AND EDUCATION, AND RELATED AGENCIES FOR THE FISCAL YEAR
ENDING SEPTEMBER 30, 2022, AND FOR OTHER PURPOSES
__________
Department of Education
Department of Health and Human Services
Department of Labor
Nondepartmental Witnesses
__________
Printed for the use of the Committee on Appropriations
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
_________
U.S. GOVERNMENT PUBLISHING OFFICE
44-181 PDF WASHINGTON : 2023
COMMITTEE ON APPROPRIATIONS
PATRICK LEAHY, Vermont, Chairman
PATTY MURRAY, Washington RICHARD C. SHELBY, Alabama, Vice
DIANNE FEINSTEIN, California Chairman
RICHARD J. DURBIN, Illinois MITCH McCONNELL, Kentucky
JACK REED, Rhode Island SUSAN M. COLLINS, Maine
JON TESTER, Montana LISA MURKOWSKI, Alaska
JEANNE SHAHEEN, New Hampshire LINDSEY GRAHAM, South Carolina
JEFF MERKLEY, Oregon ROY BLUNT, Missouri
CHRISTOPHER A. COONS, Delaware JERRY MORAN, Kansas
BRIAN SCHATZ, Hawaii JOHN HOEVEN, North Dakota
TAMMY BALDWIN, Wisconsin JOHN BOOZMAN, Arkansas
CHRISTOPHER MURPHY, Connecticut SHELLEY MOORE CAPITO, West
JOE MANCHIN, III, West Virginia Virginia
CHRIS VAN HOLLEN, Maryland JOHN KENNEDY, Louisiana
MARTIN HEINRICH, New Mexico CINDY HYDE-SMITH, Mississippi
MIKE BRAUN, Indiana
BILL HAGERTY, Tennessee
MARCO RUBIO, Florida
Charles E. Kieffer, Staff Director
Shannon Hutcherson Hines, Minority Staff Director
------
Subcommittee on Departments of Labor, Health and Human Services, and
Education, and Related Agencies
PATTY MURRAY, Washington, Chairman
RICHARD J. DURBIN, Illinois ROY BLUNT, Missouri, Ranking
JACK REED, Rhode Island RICHARD C. SHELBY, Alabama
JEANNE SHAHEEN, New Hampshire LINDSEY GRAHAM, South Carolina
JEFF MERKLEY, Oregon JERRY MORAN, Kansas
BRIAN SCHATZ, Hawaii SHELLEY MOORE CAPITO, West
TAMMY BALDWIN, Wisconsin Virginia
CHRISTOPHER MURPHY, Connecticut JOHN KENNEDY, Louisiana
JOE MANCHIN, III, West Virginia CINDY HYDE-SMITH, Mississippi
PATRICK J. LEAHY, Vermont, (ex MIKE BRAUN, Indiana
officio) MARCO RUBIO, Florida
Professional Staff
Alex Keenan
Kelly Brown
Michael Gentile
Mark Laisch
Megan Mott
Kathryn Toomajian
Laura A. Friedel (Minority)
Anna Lanier Fischer (Minority)
Ashley Palmer (Minority)
Emily Slack (Minority)
Administrative Support
Fiona O'Brien
Sydney Crawford (Minority)
C O N T E N T S
----------
HEARINGS
Wednesday, May 19, 2021
Page
Review of the Fiscal Year 2022 Budget Blueprint for the Centers
for Disease Control and Prevention............................. 1
Wednesday, May 26, 2021
Department of Health and Human Services: National Institutes of
Health......................................................... 69
Wednesday, June 9, 2021
Department of Health and Human Services: Office of the Secretary. 155
Wednesday, June 16, 2021
Department of Education: Office of the Secretary................. 247
Wednesday, July 14, 2021
Department of Labor: Office of the Secretary..................... 365
----------
BACK MATTER
Departmental Witnesses........................................... 435
America's Public Television Stations and the Public
Broadcasting Service....................................... 435
National Public Radio........................................ 440
List of Witnesses, Communications, and Prepared Statements....... 857
Nondepartmental Witnesses........................................ 443
Subject Index.................................................... 863
America's Public Television Stations and the Public
Broadcasting Service....................................... 863
Department of Education: Office of the Secretary............. 863
Department of Health and Human Services...................... 864
National Institutes of Health............................ 864
Office of the Secretary.................................. 865
Department of Labor: Office of the Secretary................. 866
Review of the Fiscal Year 2022 Budget Blueprint for the
Centers for Disease Control and Prevention................. 867
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2022
----------
WEDNESDAY, MAY 19, 2021
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10 a.m. in room SD-138, Dirksen
Senate Office Building, Hon. Patty Murray (chairwoman)
presiding.
Present: Senators Murray, Durbin, Reed, Shaheen, Merkley,
Schatz, Baldwin, Murphy, Manchin, Blunt, Shelby, Graham, Moran,
Capito, Kennedy, Hyde-Smith, Braun, and Rubio.
REVIEW OF THE FISCAL YEAR 2022 BUDGET BLUEPRINT FOR THE CENTERS FOR
DISEASE CONTROL AND PREVENTION
opening statement of senator patty murray
Senator Murray. Good morning. The Senate Appropriations
Subcommittee on Labor, Health and Human Services, Education,
and Related Agencies will come to order.
Today we are having a hearing on the Biden administration's
fiscal year 2022 Budget request for the Centers for Disease
Control and Prevention. It is our first subcommittee hearing
this Congress, and our first hearing on the CDC's annual
funding request since 2014.
Senator Blunt and I look forward to continuing to work with
you and our colleagues on both sides of the aisle, to build on
the progress we have made previously, and help families in
Washington State, Missouri, and across the country.
And I intend to follow the example you set when it came to
chairing hearings, Senator Blunt, and making sure that every
member has an opportunity to ask a question.
Senator Blunt and I will each have an opening statement.
And then I will introduce our witnesses, Director Walensky, and
Principal Deputy Director Schuchat. And after the witness'
testimony, Senators will each have 5 minutes for a round of
questions.
Before we begin, I do want to walk through the COVID-19
safety protocols in place. We are all very grateful to our
clerks, and everyone who has worked hard to get this set up and
help everyone stay safe and healthy.
Given the new guidance from the Centers for Disease Control
and Prevention and the Office of the Attending Physician, I
will be working with Senator Blunt, committee members and
staff, going forward, to follow the new guidance.
For today, we will be conducting this hearing following
similar COVID protocols to what we have used in the past.
Committee members are seated at least 6 feet apart. Some
Senators are participating by video conference, and while we
are unable to have the hearing fully open to the public, or
media for in-person attendance, live video is available on our
committee website.
And if you are in need of accommodations, including closed
captioning, you can reach out to the committee or the office of
Congressional Accessibility Services.
I always say a budget is a reflection of your values and
your priorities. And I think Americans can breathe a sigh of
relief knowing this budget shows they have a President who
values science and public health. COVID-19 has offered a stark
reminder of why we must make and maintain robust investments in
public health.
Experts at CDC (Centers for Disease Control and Prevention)
have been on the frontlines of this crisis from day one, and
every day since. We have seen first-hand how critical it is CDC
be equipped to effectively collect and analyze data in real
time, communicate science-based public health guidance, help
communities across the country get tests, and vaccines, and
clear, reliable information to people, and address inequities
that undermine the health of people of color, people with
disabilities, rural communities, and others.
That is why I have pushed for more funding for public
health throughout this crisis. The tens of billions of dollars
we have provided through six COVID bills so far, are supporting
invaluable public health work at every level so we can finally
end this pandemic.
It has helped update and modernize data systems needed to
track infections, variants, tests, vaccines, and inequities
among demographic groups. It has helped fight misinformation
and promote simple protective measures that have saved
countless lives, like wearing masks and social distancing.
It has helped expand our testing efforts, get vaccines into
arms, and build partnerships with trusted voices in hard-to-
reach communities. And I was pleased to hear the Biden
administration announced last week, it was investing over $7
billion from the American Rescue Plan, through CDC, to create
tens of thousands of jobs in public health at the State and
local level to fight COVID-19, and to help transition some of
those workers to permanent careers as public health
professionals.
With new cases and deaths both down over 80 percent from
their winter peaks, nearly three in five Americans vaccinated
with their first dose, and over a third of Americans fully
vaccinated, we can see the light at the end of the tunnel. But
even as we get closer to ending this crisis, we know we are not
there yet, and we cannot afford to come up short. That is why
after years of underinvestment in CDC and attempted cuts to CDC
by President Trump, this budget request is such a breath of
fresh air.
President Biden's request of $8.7 billion would increase
CDC's budget authority by nearly a quarter. I have been pushing
for more public health funding for years now. And I am excited
to say this would be the largest budget authority increase for
CDC in nearly two decades. These investments will help us
finish strong when it comes to this pandemic, prepare for the
next one, and make progress on other public health challenges.
Investments in CDC, as well as requested increases for the
Substance Abuse and Mental Health Services Administration will
help address the record number of drug overdose deaths, and the
spike in mental health issues, we have seen as a result of this
pandemic. COVID-19 has also put a painful spotlight on how
racism, sexism, ableism and bigotry hurt so many people in this
country.
CDC's recent announcement of a 2-year plan to invest more
than $2 billion to work on COVID-19-related health disparities
was an important step towards addressing this reality, and the
administration's request to dramatically increase the social
determinants of health program, Congress established at CDC
last year from 3 million to 153 million will help make sure our
response to health inequities is truly comprehensive, because
there are so many challenges we need to tackle head-on.
For example, Black, American Indian, and Alaska Native
women are two to three times more likely to die from pregnancy-
related causes than White women. And our overall maternal
mortality rate is the worst in a developed country, so I am
glad the administration budget request includes $200 million to
reduce maternal mortality nationwide, and address disparities,
an increase of 140 million.
It also invests in other public health threats that have
gone too long with too little attention. It doubles funding for
gun violence prevention research, and establishes a new 100
million community-based violence intervention program between
CDC and the Department of Justice. And it increases funding for
CDC's climate and health program by $100 million dollars.
Of course, the challenges we face are bigger than any one
budget. Before this pandemic hit, only half of Americans were
served by a comprehensive public health system. Our public
health workforce has lost 56,000 people, and State health
officials estimated a quarter of their workforce was eligible
to retire.
So we have a lot of work ahead, not just to end this
pandemic, but to build and maintain a public health system
capable of addressing other pressing public health challenges
and, of course, preparing for future ones.
That is why earlier this year I reintroduced the Public
Health Infrastructure Saves Lives Act, which would finally end
the dangerous cycle of crisis and complacency in public health
funding by providing dedicated annual investments in public
health.
Director Walensky, Principal Deputy Director Schuchat, I
look forward to hearing from both of you about how investments
like this, and like those put forward in the administration's
budget request, can help families and States across the
country. And I look forward to working with my colleagues to
make the investments we need a reality.
Finally, Dr. Schuchat, I understand you are leaving CDC
this summer after 30 years with the agency. And I know I speak
for absolutely everyone on this committee, when I say I am
grateful, grateful that we have had your expertise and
leadership, helping to see our Nation through so many public
health challenges. Thank you for your service, from all of us.
And with that, I will turn it over to Senator Blunt for his
remarks.
statement of senator roy blunt
Senator Blunt. Well, thank you, Chair Murray. This is your
first hearing as the Labor, Health and Human Services chair. I
certainly look forward to working with you in this role. We
have had a lot of success working together in the past 6 years
on this subcommittee, and I am sure we can continue with that
this year.
I also want to share your welcome to the CDC director and
the principal deputy director.
Dr. Schuchat, thanks for your service to our country, and
your incredible time at CDC. As I mentioned to you earlier as
we were visiting, I am sure there is not a single person who
knows as much about CDC as you do. And there may never be a
person who knows as much as you do after a 33-year career
there, and that long list of things that we have worked
together on in the last several years, but a list that goes
beyond that.
So Dr. Walensky, Dr. Schuchat, this is really an important
opportunity for us to hear about the CDC's budget proposal, and
understand more about CDC's priorities for this year. I don't
think there has been a year that CDC got more attention than it
got in the last year. And so the profile of CDC, the
understanding of the importance of CDC I think, is at a high
point.
I want to recognize the tireless efforts of the CDC staff,
working across the country during the pandemic. It has been a
challenging year for all Americans, but particularly for those
in public health.
Dr. Walensky, I look forward to hearing your testimony
today on the administration's fiscal year 2022 Budget.
Unfortunately, your comments will be limited somewhat by the
fact that we are really waiting for more information about that
budget. But from what we do know from the limited details
released last month, there are several areas of alignment where
we can work together.
For example, addressing the needs of the hard-hit public
health infrastructure, responding to the opioid crisis, which
has been exacerbated during the pandemic, along with other
mental health and behavioral health challenges, and continuing
the Ending the HIV Epidemic Initiative are important to both of
us.
These are critical areas that may need even more attention
as we emerge from the pandemic and gain an understanding of the
full impact, of the health impact, and the behavioral health
impact that the pandemic has had.
It also appears that Global Health Security and
Preparedness programs will continue as a priority for this
administration, as it has been for this subcommittee over the
past 6 years. During that time the subcommittee invested
heavily in these programs, increasing funding across the
department of HHS (Department of Health and Human Services) by
46 percent. Unfortunately, the so-called ``skinny budget'' also
includes what I believe are excessive areas of increases in
areas that are extremely partisan. I hope we can set those
issues aside and invest in areas of common ground that benefit
all Americans.
As this subcommittee thinks about the priorities for fiscal
year 2022, I hope we can spend time learning from the lessons
of the pandemic.
In 2020, Congress passed five bipartisan COVID relief
bills, total more than $16 billion for CDC. During the
infectious disease pandemic, that funding was critical for
State and local public health preparedness and response. I
think we would all agree that our focus on local public health
in this country is not what it was just a few decades ago, and
we can do better. Certainly those agencies and State
governments, generally, have been critical in the vaccine
distribution and planning.
Now, the other point to make is that $16 billion is a lot
of funding to absorb. To put it in perspective that is about
double your annual budget, or more than $50 million per day for
the CDC's response efforts last year.
Pretty hard to spend all of that as effectively as this
committee would like, but I think we understood that when we
were sending money to CDC to try to respond to a pandemic that
was unlike anything we had dealt with before.
We also really need to incorporate the lessons learned from
the pandemic, moving forward. It is important we highlight what
went right, when communities stepped up, when neighbors helped
neighbors, when innovators came forward to provide novel
solutions to some of the problems that plagued the pandemic.
Senator Durbin, and I, and seven of our colleagues went out
Monday to NIH (National Institutes of Health), and we saw what
happened there with testing and other things that, clearly, I
think as we look down the road, those are going to be great
advantages for us. In Missouri we saw a lot of those unique
things happen.
For example, the pandemic brought out innovation with
Washington University in St. Louis--Dr. Walensky, where you got
one of your degrees--developing their own COVID test, when
there was a nationwide shortage of testing, there was a test
that was developed at the Washington University campus to be
used on that campus.
Other resilience came through, other resourcefulness came
through. Throughout Missouri, independent and rural pharmacists
would drive 200 miles, some of them, to be sure they had the
vaccine that would be available at their location the very next
day, literally, going the extra mile, and the University of
Missouri developed a cutting-edge technology to track COVID
variants through wastewater epidemiology.
So I am proud of Missourians. I am proud of Americans
across the country, as we reached out to deal with this. We are
clearly not out of the woods yet. We need to continue to
understand and learn from the mistakes we made to figure out
where we fell short or missed the mark.
Also to understand, frankly, that there were lots of things
we know now that we did not know then. And looking back at
decisions where you don't have the same information, or
anything like it that we did now is a challenge. We need to
figure out what we learned from that, how we could have found
out more, earlier. I expect the budget to do just that. I want
to work with Senator Murray and others on this committee to do
that.
But under your leadership Dr. Walensky, I hope the agency
will make the difficult decisions necessary to make great
strides toward the enormous opportunity that I think public
health has at this moment, for the rest of this century. So
thank you for being with us today.
Chair, again, let me say, I look forward to your leadership
and the things that we can do together, and I really appreciate
where we are now compared to where we were 6 years ago. And I
think our partnership was an important part of that.
[The statement follows:]
Prepared Statement of Senator Roy Blunt
Thank you, Chair Murray. This is your first hearing as the Labor/
HHS Chair and I look forward to working with you in this role. We have
had a lot of success the past six years working together on this
Subcommittee and I'm sure it will continue this year. I also want to
share your welcome to the CDC Director and the Principal Deputy
Director.
Dr. Walensky and Dr. Schuchat, this is an important opportunity for
us to hear about the CDC's budget proposal and understand more about
the CDC's priorities for this year. I also want to recognize the
tireless efforts of the CDC staff working across the country during the
pandemic. This has been a challenging year for all Americans, but
especially those who work in public health.
Dr. Walensky, I look forward to hearing your testimony today on the
Administration's fiscal year 2022 budget. Unfortunately, I think your
comments will be limited because we are still waiting for the
Administration to release their budget. What we do know, from the
limited details released last month, is that there are several areas of
alignment where we can work together. For example, addressing the needs
of the hard hit public health infrastructure; responding to the opioid
crisis, which has been exacerbated during the pandemic; and continuing
the Ending the HIV Epidemic initiative, are important to both of us.
These are critical areas that may need even greater attention as we
emerge from the pandemic and gain a better understanding of its full
impact on our nation's public health.
It also appears that global health security and preparedness
programs will continue as a priority for this Administration, as it was
for the Labor/HHS Subcommittee over the past six years. During that
time, this Subcommittee invested heavily in these programs, increasing
funding across the Department of Health and Human Services by 46
percent.
Unfortunately, the so-called ``skinny'' budget also includes
excessive increases in areas that are extremely partisan. I hope we can
set those issues aside and invest in areas of common ground that
benefit all Americans.
As this Subcommittee thinks about priorities for fiscal year 2022,
I hope we will spend time learning from the lessons of the pandemic. In
2020, Congress passed five bipartisan COVID relief bills, totaling more
than $16 billion for the CDC. During a global infectious disease
pandemic, that funding was critical for state and local public health
preparedness and response; for public health data modernization; and
for COVID-19 vaccine distribution.
However, $16 billion is a lot of funding for the CDC to absorb. To
put it in perspective, that is about double your annual budget or more
than $50 million per day for the CDC's response efforts last year. Our
Subcommittee has a responsibility to provide oversight and ensure
accountability of that funding for the taxpayers.
We also must incorporate the lessons learned during the pandemic
moving forward. But as important, we should highlight what went right.
When communities stepped up. When neighbors helped neighbors. And when
innovators came forward to provide novel solutions to some of the
problems that plagued the pandemic.
And in Missouri, we saw a lot of that.
For example, the pandemic brought out innovation, with Washington
University in St. Louis developing their own COVID-19 diagnostic test
when there was a nationwide testing shortage.
It brought out resilience and resourcefulness. Throughout Missouri,
independent and rural pharmacists will drive 200 miles a day to provide
vaccines to vulnerable and underserved populations. They are literally
going the extra mile to ensure communities and rural areas across our
state have access to the vaccine.
And it brought out ingenuity. The University of Missouri is
developing cutting-edge technology to track COVID variants through
wastewater epidemiology.
I am proud of how Missourians, and Americans across the country,
stepped up to respond during this crisis.
But, we are not out of the woods yet. We need to continue to
understand and learn from the mistakes we made. Figure out where we
fell short or missed the mark. And I would expect the CDC's fiscal year
2022 budget to do just that. This is the time to think about a long-
term strategy and not continue to jump from one disease outbreak to the
next.
The CDC is facing unprecedented challenges, but the agency is also
presented with an enormous opportunity to bring public health into the
21st Century. Under your leadership, Dr. Walensky, I hope the agency
will make the difficult decisions necessary to make great strides to
that end. Thank you for being with us today and I look forward to your
testimony.
Thank you.
Senator Murray. Thank you, Senator Blunt. And yes, I do
look forward to working with you on this as we always have. So
I appreciate it.
I want to welcome both of our witnesses again. Thank you
for being here.
Dr. Rochelle Walensky is the director of the Centers for
Disease Control and Prevention, and the administrator of the
Agency for Toxic Substances and Disease Registry.
Dr. Anne Schuchat is the principal deputy director of CDC,
and has twice served as acting director of the agency. Welcome
to you both.
Dr. Walensky, we will begin with you for your opening
remarks.
STATEMENT OF DR. ROCHELLE WALENSKY, DIRECTOR, CENTERS
FOR DISEASE CONTROL AND PREVENTION
Dr. Walensky. Chairman Murray, Ranking Member Blunt, and
everyone on the committee, I am grateful for the committee's
support of the CDC.
I am here today, as you noted, with Dr. Anne Schuchat,
CDC's principal deputy director. I have enormous gratitude for
Dr. Schuchat's leadership and contributions over three decades,
as well as during this very challenging period during our--for
our country, and for her rock-solid support of me in my
transition into this role.
Anne embodies selfless public service, the pinnacle of
scientific and intellectual standards, and has given her heart
to our agency and the public health community. I will be
forever grateful that our paths crossed even for such a short
period of time.
The COVID-19 pandemic threw the United States and the world
into a health, economic, and humanitarian crisis. As the crisis
unfolded, it put a spotlight on the fragility of our public
health infrastructure. It illuminated great disparities in
health outcomes by race and ethnicity; reminding us that--thus
far--we have failed to address the systemic racism that results
in poorer health for people of color in the United States.
I am committed to working with you, the administration, and
our public health partners to ensure that every lesson from
this horrible crisis is used to build a better, stronger,
healthier America.
I also commit to using our public health expertise and
experience in partnership with the global community to move the
world into a safer, healthier future. CDC's fiscal year 2022
Discretionary Budget Request of $8.7 billion is an increase of
$1.6 billion over fiscal year 2021--the largest increase CDC
has received in nearly 20 years.
The increase is focused on four critical areas: building
public health infrastructure, reducing health disparities,
using public health approaches to reduce violence, and
defeating diseases and epidemics.
These increases build on the investments made in the COVID-
19 supplementals, and are an important first step in addressing
deficits in the public health infrastructure. COVID-19 not only
exposed the vulnerabilities within the United States public
health infrastructure, but also how underlying chronic
conditions and lack of access to healthcare, put too many
Americans at great risk.
Across the globe we see billions of people without access
to vaccines and medical care, which means that SARS-CoV-2, its
variants, and other infectious disease threats will continue to
threaten us all. Experts had warned for years that a pandemic
of this scale was coming, and we must expect additional
diseases to emerge.
We need to ask ourselves, are we ready? We must have a
strong infrastructure that can identify and detect outbreaks at
their source and can take quick action before diseases take
hold.
Over the last 12 years, the United States has faced four
significant emerging infectious disease threats: the H1N1
influenza pandemic, Ebola, Zika, and COVID-19; we also
confronted a drug overdose epidemic with nearly 500,000 people
dying from an opioid-related overdose between 1999 and 2019.
This increase continued into 2020 and appeared to accelerate
during the COVID-19 pandemic.
These experiences show that public health emergencies are
here to stay. Each of those threats demanded a rapid and unique
response, but none resulted in a sustained public health
improvement. Long-term investments in flexible infrastructure
will save lives and avert economic losses caused by public
health emergencies and chronic public health problems.
The fiscal year 2022 request makes initial investments to
continue public health data modernization, build the public
health workforce, enhance global health security, and
strengthen our immunization infrastructure.
In addition, we are requesting funds to help states and
communities be climate-ready and prepare to confront new health
risks, such as those associated with vector-borne diseases. The
fiscal year 2022 Budget Request also makes specific investments
in programs that work to improve health equity, such as
maternal mortality review committees. With these new outlined
resources in this request, CDC will also significantly expand
efforts to address the social determinants of health.
Proposed increases will address public health problems that
have been exacerbated by this pandemic, such as opioids,
violence, HIV, and sexually-transmitted diseases.
We, at CDC, are grateful for your support and look forward
to working together to build a sustainable and resilient public
health system that can respond effectively to emerging threats,
and meet the public health needs of every American. We will
work tirelessly to ensure the health of this Nation and the
world.
Thank you. Dr. Schuchat and I look forward to your
questions.
[The statement follows:]
Prepared Statement of Rochelle P. Walensky, M.D., M.P.H. and
Anne Schuchat, M.D.
Chairwoman Murray, Ranking Member Blunt, and distinguished members
of the Committee, it is an honor to appear before you today to discuss
how investments in the Centers for Disease Control and Prevention (CDC)
are protecting American's health, now and in the future. I am grateful
for this opportunity to address this committee, as well as for your
long-standing and consistent leadership on issues of critical
importance to the health of Americans, and the world.
It is my privilege to represent CDC at this hearing. CDC is
America's health protection agency. For 75 years, CDC has been trusted
to carry out its mission to protect America's safety, health, and
security. Even during the unprecedented circumstances of the past year,
CDC's scientific expertise, determination, selflessness, and innovation
has helped the agency continue to advance its mission. We work 24/7 to
prevent illness, save lives, and protect America from threats to our
health, safety, and security. Addressing infectious diseases and
pandemics, like COVID-19, is central to our mission. CDC's expertise
lies in our ability to study emerging pathogens like SARS-CoV-2, to
understand how they are transmitted, and to translate that knowledge
into timely action to protect the public's health. CDC identifies and
mitigates other causes of morbidity and mortality beyond infectious
diseases, such as environmental and workplace hazards and intentional
and unintentiona l injuries (such as those from falls, violence, or
overdose). CDC promotes healthy behaviors, such as exercise and
nutrition, to prevent chronic diseases such as diabetes and heart
disease, and to prevent outcomes such as stroke. We promote healthy
communities by increasing access to nutritious food and safe walking
and green space.
By deploying experts on the ground to support our state, Tribal,
local, territorial and global partners, we translate science into
implementing guidance that protects individua ls, communities, and
populations. In our work with other Federal agencies we ensure the safe
and appropriate use of medical countermeasures, including vaccines, and
collaborate with the academic and private sector to further our
understanding of new diseases and problems that affect health.
The COVID-19 pandemic threw the United States and the world into a
health, economic, and humanitarian crisis. As the crisis unfolded, it
put a spotlight on pre-existing weaknesses and gaps that threaten the
health of Americans. It brought into stark light the great disparities
in health outcomes by race and ethnicity. We must acknowledge the long-
standing and too often unstated impact that racism has on public
health. The pandemic has also highlighted our frail public health
infrastructure, and the way that frailty impacted our ability to
respond at thenecessary scale and speed.
Experts had warned for years that a pandemic of this scale was
coming. Today, we know to expect additional novel and currently rare
diseases to emerge and gain footing as a result of our changing
climate, closer interaction with animals, and globalization. Over the
last 12 years, the United States has faced four significant emerging
infectious disease threats--the H1N1 influenza pandemic, Ebola, Zika,
and COVID-19. These experiences show that public health emergencies
and, specifically, infectious disease threats, are here to stay. While
urgency demanded rapid and unique responses to each of these threats,
none resulted in the sustained improvements needed in our nation's
public health infrastructure. This lack of robust public health
infrastructure continues to present significant challenges in our
ongoing fight against COVID-19. In fact, emergencies have resulted in
the rapid build-up of infrastructure needed to address the emergency,
then dissolution of that infrastructure, often leaving no sustainable
infrastructure in place to address the next threat. This lack of robust
public health infrastructure continues to present significant
challenges in our ongoing fight to tackle COVID-19.
World-wide, billions of people do not and will not have immediate
access to COVID-19 vaccines. Cases will continue to increase, and
variant COVID-19 strains are likely to emerge, persist, and cause
outbreaks. As this becomes more common, our public health system at
home and abroad must be ready with highly sophisticated detection and
sequencing, combined with a rapid response at the source. The
unprecedented investments provided to CDC through COVID-19 supplemental
appropriations have helped our efforts to control COVID-19, and will
also go a long way toward addressing deficits in the core components of
the public health infrastructure that has long been ignored. Our
ability to respond to the next public health crisis will depend on
whether we invest in a public health system that is highly functional
on a day-to-day basis and pivots to meet new threats, rather than
continue our partial defense, which ramps up in response to an urgent
and often short-term event.
A resilient public health system can be realized with careful
planning that builds on the gains made with COVID-19 emergency
supplementals and incorporates lessons learned as a result of this
crisis, including reliable, flexible funding. The FY 2022 Discretionary
Budget Request for CDC and ATSDR includes a total funding request of
$8.7 billion, an increase of $1.6 billion over FY 2021 Enacted. This is
the largest increase in budget authority for CDC in nearly two decades
and defends Americans' health in four ways: 1) building public health
infrastructure, 2) reducing health disparities, 3) using public health
approaches to reduce violence, and 4) defeating other diseases and
epidemics.
First, building the public health infrastructure. CDC's FY 2022
request prioritizes foundational funding to rebuild the public health
infrastructure needed to safeguard the Nation's health and economic
security. Drawing on lessons learned, as well as the latest information
and technologies, CDC will begin to address long-standing
vulnerabilities in the U.S. public health network by training a larger
cadre of experts who can deploy and support public health efforts, and
building capacity to detect and respond to emerging global biologica l
threats.
Public health action is driven by data. Earlier improvements in our
systems for collecting information after other public health
emergencies, including Ebola and EVALI, facilitated exchange of health
information, linking local, state, and federal public health systems
with healthcare systems and the public. With investments in public
health data modernization in the FYs 2020 and 2021 appropriations and
the COVID-19 supplementals, CDC increased the scale and speed of these
systems during the COVID-19 response to protect people who are at risk
for severe illness (such as older Americans), those with chronic
medical conditions, and those from racial and ethnic minorities. These
advancements must be applied across the public health system and at all
levels of government. The funds requested in FY 2022 will be used to
continue building a modern disease surveillance system at CDC, which
will catalyze a multi-sectoral, comprehensive, and cohesive approach to
documenting evidence, using state-of-the-art technology and analytical
tools. CDC will continue working diligently to ensure its research and
data are of the highest quality and are disseminated nationally to
inform decision-making throughout the public health system, while
supporting advances in data systems at all levels.
The COVID-19 pandemic made clear the role that CDC labs and public
health labs across the nation play in conducting critical surveillance
and responding to outbreaks and emerging threats. CDC and state
laboratories were required to flex and surge during peak periods of
illness, far beyond routine clinical testing. In FY 2019, CDC was only
able to meet 50% of state and local health departments' stated needs
for epidemiology and laboratory capacity funding, with personnel
support being the biggest unfunded need, followed by equipment and
supplies.
The FY 2022 request will foster innovation, collaboration with the
clinical system, and a commitment to quality. Improving technologies at
the state and local levels would enable public health labs to quickly
utilize and scale up essential laboratory analyses. In a post-COVID-19
world, investments to maintain and improve laboratories will help
prevent the failures we experienced while trying to address COVID-19.
The U.S. needs a workforce of qualified public health professionals
who will prepare for, respond to, and prevent public health crises.
Physicians working for states often earn less than$150,000 per year.
This is after having taken on medical school debt of $200,000 on
average. The FY 2022 request includes an increase to build a diverse
and culturally competent workforce who can rapidly develop innovative
approaches in surveillance and detection, risk communications,
laboratory science, data systems, and disease containment. With this
funding, CDC will support critical training programs for public health
professionals that develop strategic and systems thinking, data
science, communication, and policy evaluation. Existing cooperative
agreement mechanisms will be leveraged to support public health jobs
that meet current needs and attract new personnel to work in
underserved and rural areas.
Addressing gaps in capacity across levels of government to detect
and respond to outbreaks while maintaining and surging in other problem
areas requires investments to be disease-agnostic and flexible. With FY
2022 funding, CDC will provide support to health departments to meet
national quality standards, conduct performance improvement activities,
increase communication and collaboration across the public health
system, and reshape health departments to meet changing conditions and
needs. Funding will help health departments strengthen their abilities
to effectively respond to a range of public health threats, such as
COVID-19, and build capacities that do not currently exist.
COVID-19 is a sobering reminder that a disease threat anywhere is a
disease threat everywhere. Or as stated by WHO: no one is safe unless
everyone is safe. We cannot adequately protect American lives and the
U.S. economy without addressing global disease threats wherever they
may arise. CDC's strategic investments in global health security are
critical to U.S. health security by building sustainable global
capacity to prevent, detect, and respond to emerging infectious disease
threats. CDC works in more than 60 countries on more than 150 projects
and is a key implementing agency for the U.S. Government's leadership
role in the Global Health Security Agenda. With additional resources
requested in FY 2022, CDC will build on existing partnerships with
Ministries of Health, public health agencies, infectious disease
research institutions, and international organizations to strengthen
global laboratory capacity for early disease detection, enhance disease
surveillance for accurate data to drive decision making, and foster
effective regional and global coordination.
Next, I'd like to talk about reducing health disparities. The
disparities seen over the past year among communities of color were not
a result of COVID-19. In fact, the pandemic illuminated inequities that
have existed for generations and revealed a known, unaddressed, and
serious public health threat: racism. The well-being of our entire
nation will be compromised as long as we fail to address this.
Racism is not just discrimination against one group based on the
color of their skin or their race or ethnicity, but the structural
barriers that impact racial and ethnic groups differently to influence
where a person lives, where they work, where their children play, and
where they worship and gather in community. The social determinants of
health (SDOH)--such as high-quality education, stable and fulfilling
employment opportunities, safe and affordable housing, access to
healthful foods, commercial tobacco-free policies, and safe green
spaces for physical activity--are critical drivers of health inequities
in this country. CDC is building the evidence-base for collaborative
approaches to SDOH through community accelerator planning and expanding
a network of community health workers to develop a sustainable
infrastructure to improve health equity. CDC's FY 2022 budget request
includes an increase of $150 million to use a social determinants of
health approach to improve health equity and health disparities in
racial and ethnic minority communities and other disproportionately
affected communities around the country.
This budget directly responds to health disparities recorded in our
public health data. For example, about 700 women die each year in the
U.S. as a result of pregnancy or delivery complications, and American
Indian, Alaska Native, and Black women are two to three times more
likely to die than White women. Data show that about 2/3 of these
deaths may be preventable. Children from lower-income and racial and
ethnic minority households experience a disparate, increased risk for
lead exposure.
Achieving health equity is central to addressing the HIV epidemic.
The U.S. government spends $20 billion per year in direct health
expenditures for HIV care and treatment. An estimated 1.2 million
persons have HIV and approximately 15% are unaware they have it. With
recent advancements in antiretroviral therapy and biomedical
advancements in HIV prevention, such as pre-exposure prophylaxis
(PrEP), along with effective care and treatment, we have the tools to
end the HIV epidemic. An increased investment requested in FY 2022 for
the Ending the HIV Epidemic (EHE) initiative will enable CDC to advance
the four key strategies needed to end the epidemic in the 57 EHE focus
jurisdictions. In addition, CDC will address health equity in the
entire HIV prevention portfolio, test innovation in service delivery
models to increase access to prevention services, use syndemic
approaches to broaden reach to key populations and create efficiencies,
and strengthen engagement of grassroots community-based organizations
in implementing EHE initiative.
Third, the budget request also addresses the public health epidemic
of violence. We know too well how this epidemic permanently alters the
lives of its victims and their families and puts enormous strain on our
communities and local economies. Increases in CDC's FY 2022 budget
request will help address violence through public health approaches,
which include improving reporting systems that provide the data needed
to understand and address violent deaths and injuries in the United
States.
And fourth, we must defeat other diseases and epidemics. Just as
racism underlies a number of public health issues, climate issues
underlie a number of infectious diseases and have significant health
impacts. Climate changes are associated with changes in the
geographical range of mosquitos, ticks, and other disease vectors.
Climate-related events impact a wide range of health outcomes. Some of
the most significant climate-related events--such as heat waves,
floods, droughts, and extreme storms--affect everyone. These climate
events compromise our access to clean air, clean water, and a reliable
food supply. In addition, climate events can impact the presence of
allergens and vectors, like ticks and mosquitoes, and the subsequent
health outcomes that can result from these changes in exposures. We
know that a changing climate can intensify existing public health
threats, and that new health threats will emerge: unequally distributed
risks (age, economic resources, location), increased respiratory and
cardiovascular disease, injuries and premature deaths related to
extreme weather events, changing prevalence and geography of foodborne
and waterborne illnesses and other infectious diseases, and threats to
mental health as people feel less safe.
CDC works with states, cities, and tribes to apply the best climate
science available, predicting health impacts, and preparing public
health programs to protect their communities. To do this, CDC developed
the Building Resilience Against Climate Effects (BRACE) framework to
help communities prepare for the health effects of climate change by
anticipating climate impacts, assessing vulnerabilities, projecting
disease burden, assessing public health interventions, developing
adaptation plans, and evaluating the impact and quality of activities.
With the requested increase in FY 2022, we can further expand the
Climate and Health Program by providing a larger number of health
departments with technical assistance and funding and finding
innovative ways to protect health via climate adaptations. As with
every other public health threat, we will inform our effort by building
and examining systems that collect data on conditions related to
climate, including asthma and vector-borne diseases, and coordinate
programs and communication that improve health outcomes.
The opioid epidemic has shattered families, claimed lives, and
ravaged communities across the Nation--and the COVID-19 pandemic has
only deepened this crisis. Addressing the current overdose epidemic
remains a priority for CDC. The Administration's strategy brings
together surveillance, prevention, treatment, recovery, law
enforcement, interdiction, and source-country efforts to address the
continuum of challenges facing this country due to drug use. CDC's role
is to prevent drug-related harms and overdose deaths.
The additional funding requested in FY 2022 to address the opioid
epidemic will enable CDC to provide more funding to all States,
Territories, and select cities/counties. CDC will prioritize support to
collect and report real-time, robust overdose mortality data and to
move from data to action, building upon the work of the Overdose Data
to Action (OD2A) program. To do so, CDC will partner with funded
jurisdictions to implement surveillance strategies that include
contextual information alongside data, as well as increase surveillance
capabilities for polysubstance use and emerging substance threats such
as stimulants. The additional resources requested will enable CDC to
support investments in prevention efforts for people put at highest
risk, for example, supporting risk reduction and access to medications
for opioid use disorder for people transitioning from alternate
residence (jail/prison, treatment facility, homeless shelter). CDC will
also address infectious disease consequences, such as viral hepatitis,
of the opioid epidemic.
I look forward to working together to address both the immediate
challenges ahead in our fight against COVID-19, as well as the
weaknesses in the public health infrastructure that left our country
vulnerable to this pandemic. We at CDC are grateful for your support.
We will continue to work tirelessly to ensure the health of this nation
and the world. Together, we can build a sustainable and resilient
public health system that can respond effectively to emerging threats
and also to ongoing public health needs of every American.
Senator Murray. Thank you very much. And we will now begin
a round of 5-minute questions of our witnesses. And I do ask my
colleagues to keep track of the clock, and if you can stay
within those 5 minutes.
Dr. Walensky, COVID has really exposed the importance of
having a robust and well-funded public system before a crisis
strikes; which is why I said it is so important that we make
sustained investments in public health infrastructure and
workforce a priority, including in CDC.
Over the last year Congress provided more than $8 billion
to support public health data modernization and expand the
public health workforce through six COVID supplemental bills.
What more needs to be done to sustain our public health
infrastructure and our workforce, so we don't lose gains when
the funding runs out?
Dr. Walensky. Thank you so much, Senator, for that
question.
INFRASTRUCTURE AFTER EMERGENCY
You have highlighted that we have had challenges with our
public health workforce, indeed. We have 56,000--we are down
56,000 jobs just in the last decade. We need to train and
upskill that workforce, in addition to bolster that workforce
over the years ahead. We need to keep them trained because the
science continues to evolve, we need training in
bioinformatics, in genomic epidemiology, and all of that needs
to live in our State and localities so that they are well
informed and trained over time, not just in creating a
workforce, but in keeping them skilled.
We need to do data modernization, as you noted, an initial
investment in data modernization. When I spoke early on in my
tenure to State and local health officials, I was hearing about
faxes of test results for COVID, and then manual data entry of
those results, and that those results were not received with
racial and ethnic data in them. So we had no way of tracking
how we were doing with racial and ethnic diversity across this
pandemic.
And then we need to build our public health labs. We don't
have--did not have the capacity to do genomic sequencing in all
of these labs, we have had to scale that up. And there is many
more, and in the infrastructure in the machinery, in the
technology that we need to put and deploy, not just at CDC, so
we are ready at CDC for this, but also in our public health and
localities.
Senator Murray. So I am curious; if we had had all that in
place before this pandemic, how would have things been
different?
Dr. Walensky. I think they would have been extraordinarily
different. We would have had contact tracers on the ground
ready to go. We would have been able to identify cases quickly.
We would have been able to see single, single outbreaks than in
clusters that we might have been able to pin down to contact
trace and not have outbreaks expand. I think we would not have
seen the diverse--the racial discrepancy and what happened with
this pandemic that----
Senator Murray. Because we would have known prior and made
more of a focus?
Dr. Walensky. Exactly. We would have been able to find it.
I think the testing, the inability of our public health systems
to be able to conduct these tests in massive scale up, did not
allow us to find the disease where it was, certainly, we had
not done genomic sequencing until January, we did not know
anything about the variants that were circulating here. There
are numerable ways that this could have gone better if we had
had a more robust public health infrastructure across all of
those domains.
Senator Murray. Thank you. That is a lot to think about. We
should all remember. We have now seen a lot of encouraging
progress against COVID over the last several months, and as
more people get vaccinated, and case counts, and
hospitalization, deaths are falling.
PANDEMIC TRAJECTORY
Dr. Walensky, speak to us about where we are in this fight.
How the funds Congress has provided have helped? And what we
need to focus on next to bring this crisis to an end?
Dr. Walensky. Today, I am cautiously optimistic. We have,
in the last several weeks, seen a stark downward trend in
cases. The last 2 days we have had case rates that have been
less than 20,000 per day. Our case rates now are around 30,000
per day, on average, for the last seven days; death rates, we
have been seeing at around 500 a day, still too high, but the
lowest we have seen since this pandemic began.
We have over 86 percent of Americans over the age of 65 who
have received their first dose of vaccine. And just yesterday--
today we have now 60 percent of Americans over the age of 18
having received their first dose of vaccine. I think that we
have had extraordinary progress, and we have needed the
resources to get here.
Senator Murray. So what do we need to focus on next?
Dr. Walensky. Certainly, a sustainable public health
infrastructure that is not necessarily just tied to one
disease, to one outbreak, to one disaster. We need longitudinal
money so that we are able to have sustainable infrastructure
that is up to date with the times. We need to focus on our
racial and ethnic minority groups.
They were previously under-vaccinated. We have made a huge
amount of strides just in the last 2 weeks in getting those
groups vaccinated. But we need to--and we need to get into the
communities. We need to have a public health infrastructure
that looks like the communities that they serve, and that
serves those communities a lot.
Senator Murray. Should we be worried about the variants?
Dr. Walensky. I think we would be remiss to say that we are
out of the woods. This pandemic, this virus has sent us too
many curve balls to say that we--too early to declare victory.
Certainly, with the virus circulating in other parts of the
world that is in high degree that it gives the opportunity for
more variants to emerge, so I still am--it is among the things
that keeps me up at night. But right now the variants that we
see here and we are doing a lot of sequencing now, demonstrate
that our current vaccines are working.
Senator Murray. Okay. Thank you very much.
Senator Blunt.
Senator Blunt. Thank you, Chair.
CHANGES TO MASK GUIDANCE AND REOPENING
Let's talk about the guidance that came out last week on
masks for people who have been fully vaccinated. There seems to
be some concern about how that would be applied. I listened
this morning to the CEO (Chief Executive Officer) at Target,
who was on CNBC, and he said that--they had followed all the
CDC guidance up till now, which meant until last week people in
their stores had a mask on, this week people in their stores
don't have a mask on unless they want to have a mask on.
In the Capitol, the attending physician, who has been the
person we look to, put out guidance last week that said: on the
Capitol grounds you would not need to wear a mask if you were
vaccinated, but the Speaker decided that she was going to keep
the mask mandate in place for the House until everyone was
vaccinated.
What are you seeing there? And what kind of further
direction have you been able to give? I know just yesterday the
President had his mask on part of the time, largely based, it
seemed to me, on what other people around him were comfortable
with. But give us some more thoughts on that.
Dr. Walensky. Thank you, Senator, for that question. I
think the first thing that we should do is celebrate where we
are in this pandemic, that we can even be having this
conversation, that cases are now down to 19,000 a day, reported
this morning. As those cases are coming down, people are
longing to understand what this means next.
How do we open up again? How do we take our masks off? With
those cases coming down, and now the fact that every American
who wants a vaccine has access to one, if you have not texted,
text your zipcode to GETVAX (438829), you can find vaccine
wherever you are in the country. Five pharmacies will show up
so you can get the vaccine.
So we now have cases coming down and access to vaccines for
everyone who wants one. Just in the last 2 weeks, we had
scientific data emerge in three important areas, (1) that the
vaccines are working in the public the way they worked in the
clinical trials. That doesn't always happen, but it happened
here. And we had one of the largest studies published on Friday
in the MMWR (Morbidity and Mortality Weekly Report).
(2) That the vaccines are working against the variants we
have here circulating in the United States. There have been
data, neutralizing data that demonstrates against B.1.1.7,
against B.1.351. These vaccines are working.
And (3), something that was not studied in the clinical
trials is, can you--if you were to get infection with SARS-CoV-
2 and were vaccinated, could you give it to somebody else? Were
you silently able to spread it? Those data were not covered in
the clinical trials, but now data have emerged again, that have
demonstrated, even if you were to get infected during post-
vaccination, that you cannot give it to anyone else.
Senator Blunt. Yes.
Dr. Walensky. So that scientific data was enough for us to
move forward. People had said we moved too slowly, people have
said we have moved too fast, we moved at the speed that the
science gave us.
Senator Blunt. Well, I think that is right. I do think on
the last topic if we--not evaluating, whether we could have
made that decision quicker. But I do think that decision that
you don't have to wear a mask once you have been fully
vaccinated, will encourage people to get vaccinated. I think
the fact that that is out there is good. I hope we got it out
there as quick as you were comfortable having it out there.
RACIAL DISPARITIES
On your comments about racial health disparities which, of
course, I am not for racial health disparities, and more than
happy to look at that; what about the other obvious health
disparities, like how low income, health disparities regardless
of race, or rural health disparities? Are we just going to
focus on racial health disparities, and leave those others
behind? Or why were those the disparities you specifically
mentioned in your comments?
Dr. Walensky. We have seen a lot of data on racial health
disparities in this pandemic. But, Senator, you are absolutely
right. Twenty percent of Americans live in rural areas. As we
talk about social determinants of health, this is not just
racial--on racial lines, this is urban and rural.
We just, yesterday, had an MMWR come out that demonstrated
that rural Americans were getting vaccinated around 39 percent,
while non-rural counties were at 46 percent. So we are intent,
and our values are going to be, to have public health reach all
areas, all Americans.
Senator Blunt. I am glad to hear that. My last question
here before I run out of time would be on drug overdose deaths.
You know, we saw this committee work really hard on this topic
for about four straight years, and we felt we were making some
real progress. And I think we were, the numbers were going down
every year, but in 2020 we had the highest number to date of
drug overdose deaths. Just comment briefly on that before my
time is up here.
Dr. Walensky. It is tragic. Before being here, I was an
infectious disease doc on the wards at Mass General, and while
we were talking about deaths, the people on the wards were also
talking about chronic infections, endocarditis, epidural
abscesses, leaving young people paralyzed.
So we were making some progress, and this pandemic hindered
that progress. And we, again, need to address this issue.
Senator Blunt. Thank you.
Senator Murray. Thank you.
Senator Durbin.
Senator Durbin. Thank you, Madam Chairman.
And Dr. Schuchat, let me join the chorus. Thank you for 33
years of remarkable service. I have a question for you in a
minute, but I wanted to start with a little different approach.
LESSONS LEARNED
And let me say that I think this pandemic has not broken
us, but it has taught us where our system is broken, and there
are many areas we need to look at seriously. If you take a look
at the public health scorecard and try to find an objective
measure, the one that I return to frequently is the fact that
the United States has less than 5 percent--has less than 5
percent of the world's population, yet 20 percent of the COVID-
19 infections and deaths. And that tells us we can improve
dramatically.
Where did we shine in this effort? Certainly vaccines, the
quick response as we learned again this week, and the visit to
the NIH, was because we were prepared, and we had the science
ready, and we had good fortune in identifying the culprit, and
in devising an effective strategy to go after it with vaccines.
I would also add that the Warp Speed program appears to
have dedicated and invested funds in a dramatic way at a time
when it was very important. And I think that accelerated the
availability of the mass vaccines, and I give the Biden
administration credit for administering them, and distributing.
So those are the positive sides.
But one of the messages learned, that I learned out at NIH,
was now let's get honest about this. We not only have to bring
this pandemic to an end, we have to prepare for the next
pandemic, which may be 5 years away or 15 years away. We don't
know. But history tells us there will be another one. And the
question is: will we be ready for it?
The CDC is going to play a critical role in this. And the
first question I have to ask is to Dr. Schuchat. After 33 years
of observing this agency and its role in the American scene
when it comes to public health, there is a fear that it has
been politicized in the last 4 years, or maybe even before.
That now public health issues are so political, with the
division on whether to get a vaccine, or a vaccination or not,
seems to break out on party lines and political lines. We have
reached a new stage.
What is your thinking? And having observed and worked with
the CDC all these years, about this politicization--if that is
the word--of public health?
Dr. Schuchat. Thank you so much for your comments and your
question. The viruses don't vote, and the pandemic has really
told us that everyone is vulnerable, everyone in America, and
everyone around the world. And CDC is a science-based agency,
and we lead from science. We are data-driven, and we work
together with State and local partners who reflect the values
of their communities. So I think that focusing on the science
and the service mission of the agency is what we need to do.
Senator Durbin. Have you noticed any change, recent change
in terms of the political image of CDC, which tries to be
apolitical?
Dr. Schuchat. You know, this pandemic has been so difficult
for--you know, for the Nation, I think for all of us in public
health, and certainly for our colleagues around the world. The
messaging has really been difficult, you know, very conflicting
messages that left Americans confused.
And so I think we are committed to clear, honest
communication of what we know, and what we don't know, and what
we recommend people do. So I do think the messaging environment
during this pandemic has been really tough.
Senator Durbin. I would agree with that.
GUN VIOLENCE
Dr. Walensky, I am worried about gun violence. I believe it
is a public health issue because I represent the State of
Illinois and the City of Chicago. And we have the equivalent of
a mass shooting every weekend in Chicago. It is a disaster in
terms of its impact on the lives of many people, and the life
of the city.
You have a proposal to make a-hundred-million-dollar
investment through the CDC, in community-based violence
intervention, working with neighborhood organizations and
hospitals to deliver services. I recommend to you a program,
which we started in Chicago called the HEAL Initiative. I will
send you some information on it. But I would like for you to
say a few words about what you anticipate that $100 million is
going to be used for.
Dr. Walensky. Thank you, Senator. Our intent here is to
look for areas in high-violence cities, where we can accumulate
data, we can get accurate information, where we have actionable
interventions to prevent all areas of violence, community
violence, domestic violence, suicide, to increase public health
using those resources in areas that have been highly impacted.
We want actionable interventions for prevention.
Senator Durbin. Thank you.
CHILD MENTAL HEALTH
Madam Chair, I would just say in closing, you are in a
unique position being on the Authorizing and Appropriating
Committee, but one element I hope we don't overlook, and I know
you feel sensitive to this as I do, is the need in schools to
have access to counselors, mental health counselors, and maybe
traditional school nurses, so that any public health effort,
which should focus first on our children, has the wherewithal
to do that effectively. I find that we have allowed that to
lapse in many areas of my State.
Senator Murray. Thank you, Senator Durbin.
Senator Hyde-Smith.
Senator Hyde-Smith. Thank you, Chairwoman Murray, and
Ranking Member Blunt for having this hearing. And I certainly
appreciate the speakers that are here today.
And Dr. Walensky, I appreciate being able to visit with you
last week to discuss your work as director at the CDC. I
thought we had a very good conversation, I certainly admire the
work that you have done.
And Dr. Schuchat, I certainly admire the work that you have
done over the past many years.
RURAL HEALTH DISPARITIES
I will be brief with my questions, but one thing that I am
really concerned about is rural healthcare. I had the
opportunity this past Saturday morning to visit with David
Ready. He is a pharmacist in a town in Mississippi, Monticello,
Mississippi; that has less than 1,500 people, and the concerns
that he has about them being able to get their medicines. The
reimbursements they get, because they are so small, they don't
buy in bulk.
So those are things that I am sure that we will be having
other conversations about. But the COVID-19 pandemic has
highlighted numerous aspects, obviously, of our healthcare
system that need improvements. One of them that we all
recognize is the disparities of Americans living in rural
health areas.
Addressing health infrastructure in rural areas is a
serious concern, and as I said, one of my top priorities, and
while the CDC has undertaken efforts to address that, there is
no entity within the CDC tasked specifically with this work.
And that is concerning to me.
I believe establishing a new Office of Rural Health within
the Center of Disease Control would be an important way to
support rural communities through the end of this pandemic, and
to prepare for any other future public health crises that we
could be faced with.
And, you know, I just envision this office to be empowered
to look across CDC programs, to ensure the work of the agency
is properly addressing the health needs of the 57 million
Americans who live in rural communities.
Director Walensky, how strongly do you support establishing
an official Office of Rural Health within the CDC? And how can
we work together to get this done, if you see that the way that
I see this?
Dr. Walensky. Thank you, Senator. As you noted, we have 20
percent of Americans, 57 million Americans living in rural
areas. Part of the deep need for investment in a public health
infrastructure is to develop a workforce that looks like the
community, that is from these communities, that knows how to
access and reach these communities, which is exactly one of the
challenges that has that has occurred during this pandemic. And
one of the reasons we had a differential distribution of
vaccines between rural and non-rural communities.
We also know that there are other issues, outside of COVID,
where we have learned from COVID, such as telehealth. We had a
previous MMWR that demonstrated, ironically, that telehealth
was not reaching rural communities. And that is, in fact, one
of the areas that we should be using telehealth. So why was it
not reaching their rural communities? CDC is investigating this
just by virtue of the fact that they have had several MMWRs in
the last 2 weeks examining these issues.
So as part of the public health infrastructure and the
disease agnostic infrastructure that works on labs, that works
on workforce that works on data; we are invested in urban
communities as well as rural communities.
FUNDING FLEXIBILITY
Senator Hyde-Smith. And I think a lot of that is broadband
issues as well, that we have to get addressed. But I understand
the CDC has a highly categorical manner for providing funding
to State health departments, with most funding tightly tied to
specific diseases, or specific purposes. And I am concerned
that restricting CDC money to specified activities prevents
States from being able to address issues that vary from State
to State, because all of them are different, and it makes it
difficult to respond efficiently to emerging challenges like
COVID-19.
And I have always been big on flexibility because the
States really know where their needs are, and I believe greater
flexibility on funding might allow States to better target
resources. So I just wanted to mention that to you, of the need
for flexibility there, that we sure saw that our hands were
tied in some cases during COVID. So I just wanted to address
that with you.
Dr. Walensky. I would just echo your thoughts and say, yes.
That one of the things that has been challenging for us at CDC
is the line items that have to go to X or Y, when in fact what
we need is the infrastructure, the disease agnostic
infrastructure, so that when we see community--this community
needs this, but they may both need to establish a lab, but one
needs broadband and the other needs a genomic sequencer that
we--it is flexible enough to be able to make sure that each of
the communities can scale up for what they need. Absolutely.
Senator Hyde-Smith. Thank you. That is very encouraging.
Thank you.
Dr. Walensky. Thank you.
Senator Murray. Senator Reed.
Senator Reed. Well, thank you, Madam Chairwoman; and thank
you Director for your extraordinary work.
317 IMMUNIZATION PROGRAM
I have been now working and trying to bolster the Section
317 Immunization Program for many years. And as we recognize
this year, because of the pandemic, there has been significant
increases in vaccination funding going out, and building an
infrastructure. But I don't want to take our eyes off the long-
term need for Section 317 programs to sustain improvements that
have been made in terms of routine immunization, which must be
given.
And so will the CDC be requesting an increase in funding
for the 317 Program this year, Madam Director?
Dr. Walensky. I am going to let Dr. Anne Schuchat take that
question.
Dr. Schuchat. I want to thank you for your long-time
support for the immunization needs of the Nation, and the
incredible progress we have been able to make, particularly
among children. COVID, the pandemic, has really highlighted
that we are not where we needed to be with adults. And that was
part of the slow start that we had in terms of getting--you
know, having the scale up of vaccination.
So there is a lot more work to do to catch up for the
vaccines that were not given during the pandemic, in children,
and to strengthen our infrastructure for adults going forward.
And so that work is part of the priorities for the agency.
Senator Reed. Thank you very much.
SUICIDE PREVENTION
Dr. Walensky, this is not the first time I think this
thought has been bridged, but the suicide epidemic has been
startling across the country related to the pandemic, and
perhaps related to other factors, and CDC has released some
startling statistics recently about suicide. And I know that
the CDC has launched some new suicide prevention efforts over
the last couple of years, and let me you to continue to do
that. But I understand only a handful of grant applications
were able to be funded. And one of those that were not funded
was from my State, but we were not alone. And what are you
intending to do with respect to the overall suicide epidemic
and also the more robust funding for prevention?
Dr. Walensky. Thank you, Senator. This is such a
challenging area it was--we had scale-up of mental health
challenges before the pandemic, right? So these were issues
that we really needed to tackle before the pandemic. And we saw
during the pandemic that these have only gotten worse, among
our youth, among our middle aged, we have seen challenges even
since the pandemic began.
So part of our resources that we are requesting are to
scale up these efforts. Again, we need surveillance data. We
need to understand how much this is a challenge. How many
people are presenting to the emergency room. We need toolkits
to deliver to States, to physicians, organizations, so that
they can--they are empowered as to how to prevent it. And then
we need actionable implementation that we can do for prevention
in areas of mental health.
LEAD POISONING PREVENTION
Senator Reed. Thank you. One final topic is lead exposure,
which I have been working on through my responsibilities on the
Banking Committee, and also the Appropriations Subcommittee on
Housing and Urban Development, over the last year rates of
screening for lead poisoning have decreased, obviously, as you
know, movement and these types of activities have been
curtailed. And then I think the statistics, although it would
probably be very dubious coming out of the last year because of
all these other factors, but it is a continuing problem.
And right now the CDC's Lead Poisoning Prevention Program
is at a high mark of $39 million. But we know more funding is
needed, and we also know that this initiative
disproportionately impacts lower-income communities because of
the housing circumstances, generally.
And I would hope that the President's CDC budget will
prioritize this work, keep increasing funding and focus. I
would note, he is going after the lead pipes, which I applaud.
But in many respects, particularly in older communities like
mine, the issue is not lead pipes, it is housing and lead
paint, and it is a whole series of issues.
Dr. Walensky. Thank you. I think this raises a very similar
point, as was previously raised by Senator Hyde-Smith, that
each community needs individual things to improve the health of
their community, which is why the public infrastructure
flexibility, the funding to be able to get the resources that
you need in individual communities.
One will be--you know, we need resources for broadband, but
one will be, we need resources for lead. And as you note we,
again, had an MMWR that demonstrated exactly what you said.
Screening for lead this past year has gone down. We know we
have missed lead toxicity that we really need to make up for.
Senator Reed. Thank you very much.
Thank you, Madam Chairwoman.
Senator Murray. Thank you.
Senator Moran.
Senator Kennedy.
Senator Kennedy. Thank you. Madam Chair.
Madam Director, thank you for being here today; I know how
busy you are. I have been in my office listening to some of the
testimony of both of you. And I am a little uncertain about
some of the answers, which is probably a shortcoming on my
part.
MASK GUIDANCE
Madam Director, could you, in one minute, summarize for me
what the recommendations are today from your agency about
wearing masks?
Dr. Walensky. Absolutely. First of all, can I just say,
thank you for your YouTube video, for promoting vaccines, which
I just adored.
Senator Kennedy. Did you like my singing?
Dr. Walensky. Yes, I did. Thank you very much for doing
that.
Senator Kennedy. You are under oath, now, madam.
[Laughter.]
Dr. Walensky. Yes, I did--even so, I did.
Senator Kennedy. Thank you for that.
Dr. Walensky. Last Thursday, we released guidance that
demonstrated for an individual who is able--who is fully
vaccinated and not immunocompromised, that they are able to
safely unmask with the exceptions--certain exceptions, of
course, in travel corridors, healthcare settings, that if you
are an individual you can safely unmask if you are fully
vaccinated.
Senator Kennedy. Inside and outside?
Dr. Walensky. Inside and outside.
Senator Kennedy. Okay. What role do the State regulations
play with respect to that?
Dr. Walensky. We are working now to update all areas of
guidance, but here is what is really, I think, important to
understand. We are not a homogeneous United States. We have
counties that have less than 20 percent vaccinated.
Senator Kennedy. Yes, ma'am. But I don't want to get too
off, off the question here. If I walk over to the House of
Representatives, do I have to wear a mask?
Dr. Walensky. Those are locally-driven policies, but we
felt that it was important for the science to--for us to convey
the science of what is safe for individuals.
Senator Kennedy. Well, I am trying to understand the CDC
recommendations, and I appreciate it. Based on the CDC
recommendations, if I walk over to the House, are you
recommending I wear a mask?
Dr. Walensky. If you are--if you are by yourself walking
over to the House and you are fully vaccinated?
Senator Kennedy. No, ma'am. Once I am over there. I am
vaccinated. Once I am over there and I am talking to some of my
colleagues?
Dr. Walensky. We have really encouraged that the policies
of mask-wearing be locally driven. And the reason for that is
because every community, every county, has different rates of
disease and different rates of vaccination. And that is really
what----
Senator Kennedy. What is different about the House? Do you
know?
Dr. Walensky. I don't actively--I don't know the rate of
vaccination around the Capitol, nor the rate of disease around
the Capitol off the top of my head.
Senator Kennedy. Okay. What about airplanes?
Dr. Walensky. What is the policy on airplanes? Currently,
the policy on airplanes is to wear a mask.
Senator Kennedy. Okay. And why is it different on an
airplane as opposed to a restaurant?
Dr. Walensky. So the CDC provides guidance for what is safe
to do. The Federal policy is obviously an interagency policy
that we need to look at across different agencies. What I will
say though, is that there is very little choice when you board
an airplane as to----
Senator Kennedy. Right.
Dr. Walensky [continuing]. Who is going to be sitting next
to you, who is around you. And also, airplanes may be a place
where we have more variants, because of the travel from
international places.
VIRUS ORIGINS
Senator Kennedy. Okay; last question. What, in your
opinion, was the origin of the virus?
Dr. Walensky. This has been studied by the WHO----
Senator Kennedy. Ma'am, I am asking your opinion.
Dr. Walensky. I don't believe I have seen enough data,
individual data, for me to be able to comment on that.
Senator Kennedy. What are the possibilities?
Dr. Walensky. Certainly, the possibility is that most
coronaviruses that we know of are of origin from--that have
infected the population, SARS-CoV-1, MERS, generally come from
an animal origin, and----
Senator Kennedy. Are there any other possibilities?
Dr. Walensky. Certainly, a lab-based origin is one
possibility.
Senator Kennedy. Okay. Is the United States funding gain-
of-function research?
Dr. Walensky. Not to my knowledge.
Senator Kennedy. Okay. Can you give an answer to that for
me, and let us know, let the committee know?
Dr. Walensky. Dr. Fauci would be the one who knows best,
and he testified last week----
Senator Kennedy. Dr. Fauci seems confused. I am asking--
with all due respect--I am asking you to get us that
information. Where throughout the world, including, but not
limited to the United States of America, are we doing research
on these viruses to make them contagious in order to study
them? That is what I mean by gain-of-function.
Dr. Walensky. I understand. I understand. We certainly can
have our staff look into this. I don't know that we have access
to labs across the world, just the ones that are funded here in
the U.S.
Senator Kennedy. Yes. But you are the Head of the CDC. I
bet if you--I bet that you get your phone calls returned.
Dr. Walensky. Okay.
Senator Kennedy. Would you get us that information?
Dr. Walensky. I would be happy to give you the information
to the best of my ability.
Senator Kennedy. Okay. And I am going to do long--a
complete album of my singing. I will send you--I will send you
a courtesy----
Dr. Walensky. Would you sign that, please?
Senator Kennedy. Sure. Thank you. Thank you, both, for
being here.
Thank you, Madam Chair.
Senator Murray. Senator Baldwin.
Senator Baldwin. Thank you. Madam Chair.
MASKS IN WORKPLACES
I want to pursue a similar line of questioning that we just
heard from Senator Kennedy, with regard to masking guidance.
And when I reflect from the period of time when the pandemic
was first identified, the Department of Labor and the agency
charged with occupational safety and health, did not issue any
sort of emergency temporary standard with regard to workplaces
relating to this pandemic.
And, frankly, while there has been much work done on that
in this new administration, we don't have one yet, and so I am
just delighted by the progress we are seeing. Generally, I see
that light at the end of the tunnel, getting brighter, and
brighter, and brighter, and certainly the CDC's updated mask
guidance for those who are vaccinated is a reflection of that
progress.
But I am concerned about the impact of this guidance on
workers, and particularly those who work in crowded conditions,
such as meat-packing facilities, where we have seen horrendous
outbreaks in the past year.
So, Dr. Walensky, I am wondering when we can expect perhaps
more detailed guidance for workplaces, such as meat-packing
plants, and other crowded facilities where there is going to be
a mix of vaccinated and unvaccinated workers? And how that is
going to interact with the very recent CDC guidance on mask use
for those who are vaccinated? What should workplaces be doing
right now?
Dr. Walensky. Thank you so much, Senator Baldwin. The meat-
packing situation was really, really difficult, so many, people
affected and lives lost. And a real challenge for the Nation to
react to that.
Updating guidance for workplaces, including the higher-risk
ones is a high priority for us that we are actively working on.
As you know, the initial individual guidance came out last
week, but updating guidance for particular settings is
critical. Our National Institute of Occupational Safety and
Health is working closely with OSHA around getting the best
science to the Department of Labor who has regulatory
authority, but we are at CDC, updating our guidance for the
particular settings in light of the newer science.
Senator Baldwin. I appreciate that.
PUBLIC HEALTH COMMUNICATION
I want to ask a question of you, Dr. Schuchat, about the
importance of communication in public health. Early in the
pandemic, again, we had to get out a lot of information on what
COVID-19 is, how it is spread, what precautions people can
take. And, likewise, now we are in the vaccination phase, and
we have to communicate about its safety, efficacy,
availability, et cetera.
Last year, I wrote the CDC requesting that they provide
information on the spread of COVID-19 in Hmong language. The
CDC later updated their material, which was extremely helpful
for Wisconsin's vibrant Hmong community. But we also need to
make sure that we are doing exactly the same to make
information on the COVID-19 vaccine accessible and available
for all communities.
So, Dr. Schuchat, how is the CDC using what it learned from
sharing information about the spread of COVID-19 to communicate
the importance of getting vaccinated, to those who have limited
English proficiency? And will the CDC be making information on
the COVID-19 vaccine, and how to get vaccinated available in
more languages?
Dr. Schuchat. Yes. Thank you so much for that set of
questions. I think that communication has never been more
important, nor more difficult than the past year, and reaching
people with limited English proficiency has been really
important.
We have a toolkit available in 34 languages, and our
vaccine information, including our V-safe, the little app that
helps people follow side effects after getting vaccinated, is
available in multiple languages. But it is not just what we
say, it is how we say it, and who says it; and so one of our
strategies is working through trusted messengers and partners
of the community, from the community, who work with groups day
in and day out, and so part of our strategy is funding of
jurisdictions for them to have community-based groups really
get that message out in ways that are accessible.
These are really important issues, as we know. You know,
back to the meat-packing outbreaks, we had people speaking
multiple languages in very close quarters at risk for spread,
but also not necessarily knowing who they could trust in what
they should do. So we clearly want to get the vaccine
information to them.
Another thing I would mention is the partnership that CDC
and the administration has had with HRSA (Health Resources and
Services Administration), around the federally-qualified health
programs, because they have--the federally-qualified health
centers have a real concentration of patients served with
limited English proficiency, in both mobile clinics for
vaccination, and through community clinicians--community
vaccination sites. They have been able to reach those groups.
Senator Baldwin. And Senator, if I am might add, just real
briefly. One of the things that would be really helpful for us,
is working with those industries to encourage employers to get
their employees vaccinated, that time off, paid time off, to
ensure that they--when they returned to work they are
vaccinated.
Senator Murray. Thank you, Senator.
Senator Braun.
Senator Braun. Thank you, Madam Chair.
MASK GUIDANCE FOR VACCINATED INDIVIDUALS
Dr. Walensky, I am glad that the recent ruling was made
that if you are vaccinated, you don't need to wear a mask. I
think it was getting very confusing for not only getting more
people vaccinated because they were saying, well, why should I
get vaccinated if I still have to wear a mask? So thank you for
that.
But I do have a question. I know that on March 29, the
President was criticizing some governors about removing mask
mandates. And of course that now has changed. And I think the
reason is what I have just said. But what about, since the
science now, and the guidance is clear, what about local mayors
and governors that are not following the science, when that has
kind of been ballyhooed as the thing to do. I believed in that
from the get-go as well, especially when the tools were very
uncertain, distancing and all that stuff, made sense. And I
thought you were silly not to abide by it.
What about now? For the places that are--I think there is a
liberation feeling out there, and thank goodness for the Warp
Speed, and getting the vaccines in the arms. Is this
unnecessary for governors and mayors across the country to
still keep a mask mandate in place?
Dr. Walensky. Thank you for that question, Senator. We
released guidance on Thursday that said for individuals, if you
are vaccinated, fully vaccinated, you can take off your mask
with several exceptions. One of the things I think that is
really key in this is to recognize that we are not a
homogeneous country.
That there are some areas that--some counties that still
have less than 20 percent of people vaccinated. There are some
counties that still have greater than a hundred cases per
hundred thousand in a seven-day period of time. And so I
actually think, as I look at the map, a very heterogeneous map
of how we are doing with cases, how we are doing with
vaccinations, the decisions about whether to take off a mask
mandate will have to be made at the local level, have to be
made at the community level.
There are still some communities who are suffering. We know
African-Americans lost 2.9 years of life compared to White
Americans losing 0.8 years of life. And they are probably the
communities that got access to vaccines last. We are working on
that. We have had extraordinary improvements in our access to--
in our racial and ethnic minorities having access to vaccines.
But I do think that these need to be made at the local and
community level for exactly that reason.
Senator Braun. Do you think it will be confusing though,
even for those places that have lagged in getting their
citizens vaccinated to see that there is not that incentive in
place, even in the places that have been slower to do it, that
would be an encouragement. If they see people without a mask
and they say, well, they are vaccinated. I want to get one.
Dr. Walensky. I think it would be really amazing if our new
guidance got more people vaccinated, and was an incentive for
more people to get vaccinated. But I don't make CDC guidance,
my whole agency does not make CDC guidance based on what it
will help people do. We have to do it based on the disease that
is out there, the access to vaccines, and based on the science
that has emerged.
I really am hopeful that that will help to incentivize
people to get vaccinated, but that was not the reason for our
guidance.
COVID IN INDIA
Senator Braun. Okay. Another subject, since we are kind of
at least ebbing into a situation, it looks like here in the
U.S., other countries, some places it is still running rampant
like India. When do we turn the focus? And I think we have been
lucky that vaccinations have come this quickly, but
therapeutics would seem to be that final defense for anyone
that did not have a vaccination available. And now for the few
cases that could still slip through the cracks to where it is
impacted with so much data, such a small portion of the
population, disproportionately, and horrifically, elderly
predisposed with other conditions.
COVID THERAPEUTICS
When do we start turning our attention to helping them once
they get it? Because we are going to still have cases,
depending on variants, how strong they are, to where the
emphasis goes to therapeutics, and not vaccinations, especially
for places where the vaccine is generally working, but you
still want to have tools to help those who get it?
Dr. Walensky. Absolutely. And I know--first of all, I think
we are--you know, we are working now, we have said, if anyone
is not safe, then no one is safe. We really do need to make
sure that we have resources to other places, if variants emerge
they will come to our shores. So we have to be able to do that.
I also know that NIH has invested in making sure that we
have therapeutics. One of the first things that we had when I
was rounding on the wards last May, was Remdesivir. And that
was the first sign of an antiviral.
We don't have anything really that we can give quickly over
the--you know, by prescription to outpatients. Right now we are
relying on monoclonal antibodies. They are hard, they are
clumsy, they take a lot of resources, and they are expensive.
And so I do believe that we need, in this next phase, after we
get the majority of Americans vaccinated, we do need to turn to
antivirals that are able to be easily administered in an
outpatient setting.
Senator Braun. And a final comment. I think that is going
to be important because we don't know how much variants will
become an issue. And at some point when we have generally
tamped it down, I think it is incumbent on us to put focus on
how to help those that end up getting it, especially that are
so predisposed with bad outcomes. Thank you.
Dr. Walensky. Thank you.
Senator Murray. Thank you.
Senator Manchin.
Senator Manchin. Okay. Thank you, Madam Chairwoman.
Appreciate it very much. And I want to thank all of you for
being here.
Dr. Schuchat, first of all, thank you for your service,
many, many years of service. And I appreciate very much, what
you have done. And my first question would go to you because
you probably have the historical knowledge of how we got to
where we are.
VULNERABLE PUBLIC HEALTH SYSTEM
Over the last decade, the United States has lost over
50,000 public health jobs. And during that time we have faced
the H1N1 flu outbreak, Ebola, Zika, and now COVID, within the
last 5 years alone, West Virginia has lost nearly 30 percent of
our public health workforce. One thing we know from this
pandemic is that we were not prepared. While we have been able
to hire temporary public health workers in the last year, as
these positions they were not permanent, and are at risk of
disappearing after the public emergency, health emergency is
over.
So can you speak to how we became so vulnerable and fell
behind the curve in our ability to respond to this pandemic,
and how can we keep it from not happening again? I know you
have all touched on it, but I just cannot believe we were
this--we were this unprepared.
Dr. Schuchat. Yes. I think the state of our preparedness
was a real tragedy. And part of that relates to the public
health infrastructure over and over, we invest in response to a
crisis, but in ways that haven't provided sustainable capacity
at that frontline where the problems happen, so----
Senator Manchin. But these decisions made higher up within,
whoever the administration may have been, whether they were
Republican or Democrat. Was it made at that level? Or was it
made at the Head of the CDC?
Dr. Schuchat. The biggest funding increases we have gotten
have been emergency funds from Congress that, you know, happily
supported response for H1N1, and Ebola, and Zika, and COVID.
But the dollars that were there day in and day out to provide
reliable jobs for the local public health workforce were not
there. And whether it was State budgets or Federal budgets
that, you know, you cited the statistics of the job loss.
Beyond that, the jobs were not the same anymore. You know,
we talked about the data. Our data systems have really not kept
up with the times. We have very fragmented data systems that
have not been modernized.
Senator Manchin. And my time--my time is limited, and I
want to ask Dr. Walensky this question.
But on this Dr. Schuchat, what type of time basis would you
say that we should be looking at for funding? I mean, to have
confidence in the funding, permanent funding, over what, a 5-
year, a 10-year period? So it is consistent you know what you
can do and be prepared?
Dr. Schuchat. You know, I think the approach that was taken
for NIH to strengthen their capacity for vital biomedical
research is what needs to happen for the vital public health
infrastructure in the country, where it is not a feast and
famine.
Senator Manchin. Sure.
Dr. Schuchat. But that local, State, and Federals can plan.
Senator Manchin. And now will be the time to do it. If we
are ever going to do it, we should do it now, since it is all
very fresh in what we have been able to endure.
OPIOIDS IN WEST VIRGINIA
Dr. Walensky, as you are aware, we are facing an epidemic
within the pandemic, West Virginia is ground zero for the drug
epidemic, with the highest rate of drug overdose deaths in the
country. To make matters worse, 2020 was the worst year yet
with over 90,000 deaths, and we saw at least 47 percent
increase in the State of West Virginia with overdose deaths. So
what resources is CDC providing to States to combat the
epidemic?
Dr. Walensky. Thank you, Senator, for that question.
Senator Manchin. And also, I would have made--and the
second part of that would be: in working on helping--what CDC
is--are working on helping increasing the testing for viral
hepatitis and HIV? We have had a tremendous--horrendous
situation with that.
Dr. Walensky. I can tell you, just before coming here, I
spoke to one of my infectious disease colleagues in West
Virginia, and she was telling me that they have opened neonatal
detox units, I understand, that it is unbelievable.
Senator Manchin. Unbelievable, unbelievable.
Dr. Walensky. It is unbelievable. And so we know that we
need to tackle this. We need to counter this. We need accurate
data. We need interventions that can--and we need resources to
be able to invest in Opioid Naloxone Programs that are reaching
the community. Community health workers that can do the
outreach to talk to people and intervene at the local level
where these are happening, we need toolkits, we need
information, and mental health support services to intervene.
AMERICAN MEDICAL MANUFACTURING
Senator Manchin. Right. My time is running out. I want to
ask you that one other thing that--we produce very little of
the things that we basically needed for medicine, penicillin,
do you think penicillin should be produced in America? Do you
think doxycycline should be produced, an antibiotic in America?
And if so, what should we do in order to do that? Or stockpile
strategically for our own protection?
Dr. Walensky. I think we need to have a public health
infrastructure and a pipeline that allows us to respond to
pandemics, and to epidemics, and to infectious threats.
Senator Manchin. Do we have any manufacturers that are
producing these in America?
Dr. Walensky. There are limited manufacturers producing
penicillin, that I can talk to. Because, in fact, we have had
penicillin shortages, penicillin has gotten extraordinarily
expensive. And in fact, some colleagues of mine have once said,
it should be cheaper than the pipe--than the tubing it runs
through. And in fact, it is not.
Senator Manchin. Should the CDC basically--I mean, your
recommendation would be for production. We should be producing
these in America. You know, we need to have something from a
professional, like yourself, to get back to producing things in
American, and not depending on supply chains.
Dr. Walensky. So one of the things I can just mention for
penicillin specifically, is it is particularly hard given the
allergies related to penicillin. It is actually, particularly
hard to do. There are limited plants that make penicillin. But
your point is well taken.
Senator Manchin. Thank you.
Thank you, Madam Chair.
Senator Murray. Thank you.
Senator Moran.
Senator Moran. Chairwoman, thank you. Thank you and Senator
Blunt for this hearing. And welcome to our two Doctors, thank
you for service.
COLLABORATION ON BIODEFENSE FACILITIES
I have four questions I am going to try to accomplish in 5
minutes. Let me first highlight something that is occurring in
my home State. Kansas will soon be the home to the National Bio
and Agro-Defense Facility. It is a $1.25 billion research
facility, nearing completion. Its mission is to--or the
facility is to protect U.S. livestock from foreign animal
diseases, including zoonotic diseases that can pose significant
threats to human health. NBAF (National Bio and Agro-Defense
Facility) will be the first bio containment facility in the
U.S. where there is a BSL4 laboratory, which zoonotic pathogens
for which there no treatments, currently, exist.
NBAF is operated by the U.S. Department of Agriculture with
cooperation from the Department of Homeland Security, right, so
truly going to be as a state-of-the-art facility, COVID-19,
which possibly is a zoonotic disease, has only highlighted the
importance for the U.S. to invest in this type of research.
Are you engaged with USDA (U.S. Department of Agriculture)
or Homeland Security on future research that could be conducted
at NBAF in regard to the zoonotic diseases? What kind of
research NBAF would be able to provide you with benefits in
your mission of protecting human life?
Dr. Schuchat. Let me just say that what we call One Health,
the idea of human and animal health, and the environment has
been a global issue for preparedness and response. We have seen
so many terrible diseases emerge from the animals, and we have
not been sufficiently ready for them.
Whether we are dealing with the genetic sequencing of
strains, and whether the animals' strains have adapted better
to humans, or research into containment interventions, it is
really important. And so our principle of collaboration between
Health and Human Services, and the Department of Agriculture,
and Department of Homeland Security is very important.
I can say that the CDC and USDA both have oversight over
select agents that, you know, are evaluated in those BSL4
facilities. And we work very closely with them to make sure
that animal health is protected, and that human health is
protected, and laboratories that are sending these pathogens do
so safely without risk to the surrounding community.
As to exactly where we are with collaboration, I think we
will have to get back to you, but it's a--congratulations on
the facility. And I think we will look forward to working
together.
Senator Moran. This is a post\1/1\1 development, and
designed to replace the Plum Island and the research done there
on a new advanced laboratory. I would welcome the opportunity
to connect you and the folks at either Agriculture or--and
those in Kansas as well.
INTERNATIONAL COLLABORATION
What, if anything, is steps that CDC, or perhaps broader,
the Federal Government should do to bring China into this world
of helping us combat diseases, the spread of viruses? Is there
any opportunity for us to get better information, in any way
that we can insist, encourage or demand that China behave
differently than what they did, after the arrival of this--the
evidence of this disease in China?
Dr. Walensky. I think that we are all a global community at
this point, and that when there is a threat anywhere, there is
a threat everywhere. And so when it comes to our health, when
it comes to science, it is helpful to have these connections we
have in office, our regional office in China, where we exchange
scientific information. So I think around the global community,
it is important that we--that we convey scientific inference.
Senator Moran. What is your evaluation of what cooperation
occurred between China and the United States in regard to
COVID-19? And has anything changed to increase or decrease that
cooperation now?
Dr. Walensky. The WHO (World Health Organisation) has done
a study--has numerous interactions to evaluate this. My
understanding is that there is another phase of that study
underway. And I think that that is really critically important,
because quite honestly, and in my review of that study, and
many have spent many hours reviewing this study--these studies,
there was not a lot of transparency in line-level data that is
able--that we are able to use to interpret.
Senator Moran. Dr. Walensky, there is probably a longer
answer than that. And maybe we can have that when you and I
have a chance to have a conversation.
A couple of things in the 30 seconds I have left. I would
highlight that you and I have had this conversation, Dr.
Frieden encouraged me in regard to the Global Health Security
Program, and I have tried to be an advocate for that program in
this appropriations subcommittee, with some success.
And I just would--I am interested now, you don't have to
answer this question in the lack of time that I have for you to
do so, but I would love an answer that tells me how I should
prioritize. You have said it, what happens elsewhere matters to
us, and absolutely the truth and we have known that for a long
time, but how do we prioritize now with the consequences of
this pandemic in the United States?
How do we prioritize the appropriations that will go to
programs that are outside the United States, that are
protecting us as well as citizens of the world, as compared to
things that need to be done domestically, which are
significant? So I would love to have a broader discussion about
where those priorities should lie.
LEARNING LESSONS FROM COVID
And finally, I would indicate, I am reading a book, which I
do regularly, The Premonition, and I don't know whether you
have read it, but I am two-thirds the way through. It is not
terribly derogatory, but not terribly complimentary of the CDC.
And I would welcome any suggestions you have of what the
takeaway should be for the CDC, or if it is a book that is
worthy of learning something from.
Dr. Walensky. Thank you, Senator. I would be happy to
engage in those conversations. I have not read The Premonition,
although I know of it, and I know many people who are in it.
And what I will say is, there are many lessons that we can
learn, some things that we have to do better at the CDC, and
some things that we have to do better as a country, and
investing in multiyear public health infrastructure.
I think among the comments in the book that I am familiar
with was one of the issues that I heard firsthand, you know,
labs receiving results by fax and, you know, people working in
data entry to do that. That is not a public health
infrastructure of the future. It is not a way to respond to a
pandemic.
And so I think the lessons to be learned from the book, are
yes, we have to understand where things could have gone better
at CDC, and we need multi-year infrastructure resources to make
sure that we have, you know, work force, and data, and labs up
to snuff to tackle whatever they need to tackle in the future.
Senator Moran. It seems well written to me, and by a
credible author. And I would encourage you to learn from it, as
I am trying to.
Madam Chairwoman, the last comment I would make is. One of
the things, my takeaway is the failure for CDC to authorize
testing early on in circumstances in which it appears to me,
testing should have been occurring.
Senator Murray. Thank you.
Senator Shaheen.
Senator Shaheen. Thank you, Madam Chairman. And thank you,
Dr. Walensky, and Dr. Schuchat, for your service to the
country, and for being here this morning.
OPIOIDS IN NEW HAMPSHIRE
Dr. Walensky, I very much appreciated our conversation
earlier this week. And one of the things we talked about is the
continuing challenge of the opioid epidemic that we are facing
in this country. New Hampshire, like West Virginia, has been
very hard hit. We are one of the 10 States in the country that
has been hardest hit by the epidemic.
And I was pleased that Congress provided some new
flexibility to deal with the epidemic last year, by including
meth and cocaine as part of the drugs that could be included in
programs to address opioid--the opioid epidemic. But can you
talk--one of the things we discussed was the challenge that I
have heard from providers in New Hampshire that we don't have a
response for those overdosing on meth in the same way that we
have Narcan for those who have overdosed on opioids.
Can you talk about what the CDC is doing to approach this
issue and what kind of help you might have available for States
like New Hampshire?
COMMUNITY HEALTH WORKERS
Dr. Walensky. Thank you, Senator. You know, I am thinking
back to, sort of, 6 months ago and what we needed to do when we
knew that one of our patients had relapsed, and how we get them
into care. And it was our community health workers that knew
where to find them. They knew where they were getting their
drugs, and they knew where to find them, and to say, somebody
cares for you, and brought them back.
And that, I think, is what we need in our public health
infrastructure. We need the community workers who live in the
community, who are from the community to make those
interventions, to find the people. And that is really among the
things that I think this public health infrastructure is going
to be able to do. Certainly, we don't have something like
Naloxone for meth overdose and that, you know, is unfortunate
right now, and we need to address that.
And then quite honestly, we have statistics of the
overdoses and the lethal overdoses. They are terrible. And yet
we also have statistics of, you know, all these
hospitalizations that are happening among young people that I
was taking care of just 6 months ago, 30-year-olds getting
their second valve replacement.
So this is something that we have to tackle, and it is not
just that we have to tackle it with Narcan in a given
community. We have to tackle it community by community, because
there are all different kinds of communities, and we need the
workers to be able to do so.
Senator Shaheen. Well, thank you. I hope that--and I know
this is not a CDC issue--but I hope that you will weigh in, if
you have the opportunity, with the administration on the
importance of the set-aside funding for States like New
Hampshire that have been hardest hit, because that has allowed
us to up a real statewide response to the epidemic.
PFAS CONTAMINATION
I want to go on to PFAS, which is an emerging contaminant
until we get the EPA (Environmental Protection Agency) to
designate it as something else. But it is one that we have seen
very directly in New Hampshire, and especially appreciate the
response from the Agency for Toxic Substances and Disease
Registry, which has been so helpful in undertaking a
comprehensive health study in New Hampshire, Portsmouth, and
Pease former Air Force base, have been one of the sites
designated.
But one of the things we have learned is that too many of
our members of the medical community don't have any idea about
PFAS. They don't know what it is. They don't know how to
respond to it. They don't know whether testing is appropriate
or not.
And I worked with Chairman Murray and Ranking Member Blunt
last year to fund a grant program to help educate our
physicians. And I am very interested in how that unfolds, and
the work that the CDC might be doing to help an ATSDR (Agency
for Toxic Substances and Disease Registry) to educate our
medical community.
So I don't know if either of you can speak to that on the
update on where that effort stands.
Dr. Schuchat. This has been such a complex and challenging
area, and I really appreciate the leadership that you have
shown, and the----
Senator Shaheen. Thank you.
Dr. Schuchat [continuing]. Support you have given, and also
the advocacy for us to learn what we need to learn so that
people who have been exposed, and the clinicians that they see
know what to do to get a result, and then not know what it
means and what you are supposed to do about it is challenging.
So we really are incredibly grateful for the resources that are
letting us begin to pave the way to get those answers.
I don't have specifics on the results of studies yet, but I
know it is a very high priority for ATSDR and the leadership
here.
Senator Shaheen. And do you know that, at one point in the
last year, there was a suggestion that there was a connection
between exposure to PFAS and severity of COVID-19. Do we have
any more information about that?
Dr. Schuchat. You know, I know that question came up and
that we were looking into it. I don't believe we have a final.
But we can get back to you if we do.
Senator Shaheen. That would be great. Thank you. If you
could just let me know, either way, what we know about that, I
would appreciate it. Thank you.
Thank you, Madam Chair.
Senator Murray. Senator Capito.
Senator Capito. Thank you, Madam Chair. And thank you for
our witnesses today. Both of, Dr. Walensky and Dr. Schuchat,
and I wish you the best in your--we won't call it retirement--
in your repurposing. How about that? Wherever you may land?
Let me ask specifically. Senator Shaheen and Senator
Manchin mentioned, obviously, the overdose rates in the State
of West Virginia, so I won't go back through that. But I am
concerned.
HIV IN WEST VIRGINIA
Dr. Walensky, I know you have a focus on ending the HIV
epidemic. I know this is in your academic career as well. You
mentioned it in the President's budget. West Virginia received
a grant in the Integrated Viral Health--or Hepatitis, excuse
me, Surveillance targeted funds to help us address certain
areas, hotspots, I guess you would call them. But we are not--
we are not in ending HIV epidemic focused jurisdiction, nor any
of our counties. And in your testimony, you state that
increased funding in the budget is for four key strategies in
the focus areas, but not to increase the amount of focus areas.
So my question is, I think we need to be a focus area
because we have some of the highest incidence. And how do you
expand that footprint? Or, how can you help me with that?
Dr. Walensky. Thank you, Senator. As I think you noted, my
20-year career prior to January 20 was in doing exactly that.
And I was really encouraged by ending the--the mission to end
the HIV epidemic, really through a diagnosis, prevention,
treatment and response. And, you know, when the initial tranche
of HIV and the HIV epidemic money went out, it was to areas
with the highest numbers, with truly a multi-year plan to
expand to other areas that we needed to really curb things in
the areas with the highest numbers.
Take some of the lessons that we learned and expand to some
of the other areas. And so I have a vision, and hope that we
will be able to do that in the--in the years ahead, and to
continue that expansion.
Senator Capito. Thank you. Thank you. So expansion into
areas such as ours, I think that would be welcome. I would make
note that in the initial disbursement of the vaccine, our State
of West Virginia did an incredible job working with our public
health infrastructure. But I think one of the lessons that we
learned, and that I hope this becomes part of a manual to
address future issues, is public health infrastructure cannot
do this by themselves, not to what we saw at the--the breadth
of what we saw.
So what happened? We had volunteers, we had county city
governments, and we had our National Guard. And so I would
encourage you while, I think, increasing our public health
infrastructure is absolutely essential. I think growing those
partnerships could be even more essential because there is a
roadmap there to success. And so I just put that on your radar
screen, as you are--as you are looking to expand.
MASK POLICY JURISDICTION
One thing I would like to ask, and Senator Blunt and I were
in the Oval Office when the announcement was made with the
President that we were going to lift the mask mandate. And I
cannot tell you how joyful we all were as we ripped our masks
off and had a great meeting after that.
But there is confusion still. And, you know, if we are
going to get more people vaccinated, which is the ultimate goal
all the way down through the age levels, we cannot have this
confusion, because it is just: should I get my child
vaccinated? You know, should I--how old can my child be to get
vaccinated?
Does my child need to wear a mask at school? Who is the
ultimate decider here? Is that the CDC? Is it the President? Is
the governor? Is it the NIH? I mean, there is just too much
coming at young families in particular, I think, to be able to
feel, number one; that their child is safe, and they are doing
the right thing for them to go to school. But also to get rid
of that, I would say not anti-vaxxer, but vaccine hesitation. I
think that is a large part of the people that are left as yet
to be vaccinated. So how would you respond to that question?
Dr. Walensky. Thank you. The guidance that we put out on
Thursday was individual guidance for people who are fully
vaccinated can take off their masks.
Senator Capito. Right. Right.
COVID-19 VACCINES FOR CHILDREN AND ADOLESCENTS
Dr. Walensky. I have--or I was pleased actually the day
before that the FDA (Food and Drug Administration) had
authorized and the CDC had recommended vaccination with Pfizer
vaccine for individuals as young as 12 years old, that is now
recommended. And my 16-year-old has been vaccinated, and we
have a lot of community workers out there encouraging
vaccination of youth.
And, in fact, over 600,000 people between the ages of 12
and 15 have been vaccinated just in this last week. In terms of
guidance, the CDC provides science-based, evidence-based
guidance to anybody who is the consumer of said guidance,
whether it be industries, jurisdictions, importantly the
country is not uniform. And so I think you really do need to
interpret our guidance in the context of what is happening in
your community. And that is really important in the context of
a transmissible agent.
Why is that important? Because the virus is going to be an
opportunist, if you have a county that has low vaccination
rates and high rates of disease, that county may interpret our
guidance differently than a county that has high vaccination
rates, and low incidence of disease.
So we really do have to do this at the local level because,
in fact, the virus will--where there is less vaccination, the
virus will emerge.
Senator Capito. So what do you say to the under-12
population, elementary school? The parents of those children
who have low vaccination rates, which is probably close to
nothing, they have low incident of infection and, you know, all
the studies that show the younger generation is not as affected
as older and even more senior. What do you--what do you tell
them? Listen to your governor? Listen to your school Board?
Dr. Walensky. So what we would say is, vaccines are coming
for youth. We are hopeful to have, they are doing dose de-
escalation studies now down to 9 years old, soon thereafter
down to six, soon thereafter down to three, and then down to 6
months. So we are working towards getting a vaccine that will
be available for all people.
Senator Capito. So when would that be?
Dr. Walensky. Well, some of it depends on how much disease
is out there in the community. So we cannot exactly predict,
but we are hoping to have more available in late fall, and by
the end of the year but through dose de-escalation studies.
And then of course, I think that the guidance that we have
had for schools has actually demonstrated that even in the
absence of vaccinations schools can be a very safe place, given
the guidance that we have. We have recommended that schools not
change anything for this school year, because it will be hard
for our youth to get fully vaccinated before the end of this
school year. We will be updating that soon. And then given that
guidance it will be--there will be policies at the local and
jurisdictional levels.
Senator Capito. Well, I still think it--I mean, I know you
probably would agree that it is a bit confusing to folks all
around the country who have children in school. I would just--
just be as clear, and concise, and definitive, when this
science comes forward and more vaccinations come forward,
because I think it really is--it is really difficult, I think,
for parents to decide how to do the right thing. Thank you.
Senator Murray. Thank you. That ends our first round of
questions. And I will start a second round for any Senators who
wish to ask additional questions.
RACIAL AND ETHNIC DISPARITIES
And Dr. Walensky, I will begin with you. You know, the
pandemics deadly impact on communities of color show we do have
a long way to go to address systemic racism and health
inequities. Black and Latino populations are receiving
vaccinations at disproportionally low rates, even as some of
our recent polls suggest both groups are more likely than White
people to say they want to get vaccinated.
And according to the CDC website data on race and ethnicity
is available for just over half of vaccinated people. How is
CDC working to improve vaccination access and collect more data
on these demographic issues that we need to see in front of us?
Dr. Walensky. Thank you very much for that question,
because we are working hard. We have placed our community
vaccination centers, or mass vaccination centers in areas that
have high Social Vulnerability Index, they are doing an
extraordinarily good job in getting our minority communities.
Our Federal Retail Pharmacy Program sites were selected
initially, in collaboration with the State, to see how we could
get vaccine to the most vulnerable communities, to Black and
Brown communities. And just this last 2 weeks, Federal Retail
Pharmacy Programs, 47 percent of vaccines that they delivered
were to minority communities.
And then our federally-qualified healthcare centers, in
collaboration with HRSA, we have been delivering to people who
are migrant workers, to people in rural communities, and people
who have less access. One of the things we have been able to do
to improve our race and ethnicity data, and this has been
challenging because some people are electing not to report it,
is to use HIPAA (Health Insurance Portability and
Accountability Act)-compliant electronic case reporting, so
that we can use cases--or this is on the case level, not the
vaccine level, but looking at cases and then match it medical
records via Cerner, via Epic, to be able to get case-level
data.
We are working really hard with the counties to get both
racial and ethnic minority data at the case and disease level,
but then also the vaccination level. And this is, again, one of
the areas where data has--you know, our data infrastructure has
not been robust enough to deliver this to us in real time.
Senator Murray. Are you seeing any political ideology plan
to this decision to get vaccinated?
VACCINE HESITANCY
Dr. Walensky. This is a personal choice. I think once we
start saying: this group wants vaccine, this group doesn't,
then we start telling the wrong message. When I was taking care
of patients with HIV, and I was told--the new patient I had to
deliver a new diagnosis. They always said to me, you deliver
the diagnosis and then you pause, and you see what means to
them, right?
Could it mean that they are worried about their baby, they
are going to lose their job, they think they are going to die,
they can't afford their meds? I think vaccines hesitancy is
exactly this.
What is it about the vaccine that is making you hesitant?
Is it that you are scared? Do you have to take the day off of
work to get it? Is it that you saw a friend get it and they had
a reaction? Is it that, wow, how did the science come so fast?
And so this is not about politics, this is about
understanding where individuals are, meeting them where they
are, and understanding what it is that is making them--making
them hesitant.
Senator Murray. Okay. Thank you.
VACCINES IN PREGNANCY
Dr. Schuchat, recent research on the impact COVID-19
infection has on pregnant women is really alarming. One study
last month showed pregnant women with COVID-19 are 22 times
more likely to die compared to women who are not pregnant who
contract the virus. What is the latest vaccine guidance for
pregnant women?
Dr. Schuchat. Yes. Thanks so much for that issue. COVID
complicates pregnancy, so women who are pregnant and get COVID
have worse experiences with the infection, than do non-pregnant
women. More time in the intensive care unit, more risk of
severe outcomes, including those rare deaths. COVID also
complicates pregnancy by increasing the risk of prematurity,
and leading to other types of complications.
While, as you know, clinical trials rarely enroll pregnant
women, we are fortunate that there has been intense effort to
get data about women who do get vaccinated while pregnant, to
understand what happens, so that other women can learn from
that.
Based on what we know right now, we recommend that women be
offered vaccines during pregnancy, that they are eligible to
get them, and that they make a choice about it; that choice
might be based on how they value that risk or that unknown. But
we do have reassuring data right now about vaccines given,
particularly in the third trimester that have been followed and
reported. We are continuing to follow and working closely with
FDA on that. And so we will be expecting this summer to have
even more data, particularly about vaccines given earlier in
pregnancy.
Senator Murray. Is there any research about pregnant or
lactating women who are vaccinated--who are vaccinated,
transferring antibodies to their infants?
Dr. Schuchat. We have emerging data that the antibody is
transferred. And so we hope it will be like the influenza,
where, getting vaccinated during pregnancy against influenza is
really important because newborns and young children are very
high risk for influenza complications. So, good news so far,
and continuing to follow that.
Senator Murray. Thank you.
Senator Blunt.
Senator Blunt. Thank you, Chair.
VACCINE BOOSTERS
The issue of a booster vaccine obviously is out there, so
far most of the people that have said they think we are going
to need it are from the companies that are making the vaccine.
Dr. Fauci, former CDC Director Tom Frieden, others have said
there is growing evidence that there will be enduring
protection with the vaccine we have.
Now, I have been a big supporter of the Warp Speed effort
to invest early in vaccines that were not approved yet, which I
think made a big difference in availability. I do question the
BARDA (Biomedical Advanced Research and Development Authority)
decision to purchase 400 million doses of Moderna and Pfizer as
a booster dose.
Were you asked about whether that was the right decision to
make or not? And if you weren't, should CDC be involved in a
$7.9 billion decision about a booster before we know whether we
need one or not?
Dr. Walensky. Thank you, Senator. I think the first thing
to recognize, and this has been miscommunicated, so I think it
is very important, in the media, is that if you have received
two doses of your Pfizer and Moderna vaccine, you are right now
protected.
Senator Blunt. Right.
Dr. Walensky. What we are looking at is whether we will
need boosters over time. And I think that this is really--given
how hard we were hit by this pandemic, I think it is really
important to understand where we will be with that. Data
suggest from SARS, not SARS-CoV-2, but from SARS, that is
similar to coronavirus, that people have waning immunity over
time.
And if you looked at what happened in the SARS outbreak
several years ago, you saw that people were eligible for
reinfection. So there is biologic plausibility that there would
be waning immunity after you were infected. And we just don't
know when that will be.
One of the concerns has been that if we first vaccinated
our very most vulnerable, our people in nursing homes, that
they may not have had as robust a response, and that they might
be the first to--they would be a first who would need a booster
anyway, because they were vaccinated first. But in fact that
they may not have had a robust response is in----
Senator Blunt. If we spend $7.9 billion, which I guess we
did decide to do on May the 2nd, do we think those vaccines
last for some time?
Dr. Walensky. I am not under the impression those are being
made right now. I think part of the issue is what do they need
to look like? Are we going to boost with the exact same mRNA
structure as we do now? Or might we want to boost with a
variant structure? And I think those are all conversations that
are happening.
Senator Blunt. Yes. Well, I think that is a pretty big
spending decision to make based on the information we have. But
we can talk about that more, later. If we do go forward with
booster vaccines, are you all working to see if in an adult
immunization program, we would try to combine more things with
that booster? A flu shot, or whatever other shot that an adult
might need at this point?
Dr. Walensky. I think it is pretty clear that we have had
an immunization program for adults that was not prepared for
what we needed in this, in this structure.
Senator Blunt. Right.
Dr. Walensky. And yes, I think it would be advantageous.
Currently, we don't have data as to whether you can co-
administer vaccines, those data we are looking for. And in
fact, the ACIP (Advisory Committee on Immunization Practices)
just opined on this last week, because we are so behind on
childhood immunizations, 11 million behind on childhood
immunizations. So those are all the data that we are looking
for, because I think it would be really great to be able to
leverage what we are doing for COVID for influenza as well, and
vice versa.
DATA MODERNIZATION
Senator Blunt. Exactly. And I hope you will keep us posted
on that as that happens. On data, that was actually where I was
going next. You know, the data, we obviously had a data
shortage, a shortage and some confusion about what data to
input, which was not as helpful as it might have been.
Now, the committee, in what was then a fairly controversial
decision, even among our colleagues, we decided, before COVID,
to invest $50 million in base funding over the last 2 years for
data. When COVID occurred, you know, and the numbers we were
suddenly looking at and dealing with, we did another $500
million.
Dr. Schuchat, tell me where you think we are on better data
preparation in the future? Or being better ready in the future
to have data, and the tracking that comes with data? Where are
we, and where would you think--that had CDC in the next fiscal
year, for instance?
Dr. Schuchat. This is essential. The $50 million base
appropriations were vital, but you saw how behind we were. This
is critical. We are so far behind, even with the increased
resources. This is a long-term need; we are better, but we are
not where we need to be. We have made huge progress this past
year with electronic lab reporting of enormous numbers in terms
of how many people were being tested, and getting us daily
data. But the data were not necessarily complete, and as you
heard the race/ethnicity data often missing.
We have a need to move to the cloud for many of our
systems. We have a need to become--have a workforce that can
handle the data at the local level, at the State level, that
can use these sophisticated tools and not just react, but
predict. So we still have a long way to go, but COVID, we have
made a lot of progress on. We need to make that progress across
the spectrum of public health issues.
Senator Blunt. Well data, and tracking, and other things I
think are an important part of the future of health. And we
want to be helpful. And I would hope that the $550 million,
collectively, in the last couple of years has made a
substantial difference in where we are headed.
Thank you, Chair.
Senator Murray. Senator Blunt. Thank you.
I have one additional question for you. The CDC faced
unexpected difficulties, as we all remember during those
opening phases of the pandemic, especially around testing, and
delays in establishing a large-scale testing, likely allowed
the virus to spread undetected, as we know, one of the several
factors that really hampered our efforts to contain that
outbreak.
EARLIEST COVID LESSONS
Dr. Walensky, I just wanted to ask you today, what lessons
has CDC learned from the experience in those first few weeks?
Dr. Walensky. There has been a lot of research going into
what we could have done better during that period of time. My
responsibility is to own that and to make sure that we are
better. Among the challenges were quality--assurance quality
control programs that were not in place the way they should
have been. And in fact, among the things that we are doing is
to ensure that all labs, research and diagnostic labs are fully
accredited.
So we are learning those lessons. Those were hard lessons
to learn. I do also think that we need to recognize that among
CDC's responsibilities is that when we have a new infectious
pathogen, we are responsible for creating the diagnostics for
that pathogen. Once we have done so, we need interagency
collaboration with ASPER, with FDA to make--with the private
sector to ensure that we can bring it to scale.
We are now at 1.1--we did one million tests yesterday, we
are testing one to two million a day. That scale up has to be
interagency. And so, yes, we have a lot of lessons that we can
learn from what occurred, and we are learning them and taking
resources that have been provided to us so that we can, not
just take a line--a line item and improve X-lab, but we can
improve all of the labs and through this accreditation process,
for example, but then also to be able to scale at the national
level.
Senator Murray. Okay. Thank you. Thank you very much. That
will end our hearing today.
But I do want to thank both Director Walensky, and
Principal Deputy Director Schuchat for joining us.
Thank you to all of our colleagues on the committee who
participated as well.
ADDITIONAL COMMITTEE QUESTIONS
For any Senators who wish to ask additional questions,
questions for the record will be due one week after the
President's budget is delivered at 5:00 p.m. The hearing record
will also remain open until then for members who wish to submit
additional material for the record.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted to Dr. Rochelle Walensky
Questions Submitted by Senator Patty Murray
Question. Researchers in the United States continue to discover new
variants of the coronavirus that are spreading throughout the country.
Congress provided $1.75 billion in the American Rescue Plan for CDC to
increase genomic sequencing of SARS-CoV2 to identify emerging variants.
President Biden's fiscal year 2022 budget proposal includes $8.7
billion for the CDC, a $1.6 billion increase from fiscal year 2021's
budget.
How will the CDC's budget be used to help state and local public
health offices expand their surveillance capabilities to keep pace with
new and emerging variants?
Answer. In May 2021, CDC awarded $240 million in American Rescue
Plan (ARP) funds to state and local health jurisdictions to build
sequencing and analytic capacity for all pathogens of interest,
including SARS-CoV-2. CDC plans to fund these state and local labs for
additional years, with ARP funds, to continue and to build on these
activities, including funding support for equipment, supplies, and
staffing. These activities build on expertise gained through the
Advanced Molecular Detection (AMD) program. In addition, CDC is
currently soliciting proposals for construction and renovation costs
necessary to modernize the sequencing units of the nation's public
health labs, which will also be funded through ARP funds. All of these
labs are currently sequencing bacterial foodborne pathogens, and at
last count, more than 60 labs were sequencing SARS-CoV-2. A subset of
these labs are sequencing other pathogens, such as antimicrobial-
resistant bacteria and fungi, influenza virus, and the agents of
tuberculosis and Legionnaire's disease. The number of labs sequencing
these pathogens, as well as the number of pathogens they are
sequencing, is expected to increase with the availability of these
funds. CDC is also providing technical assistance, as well as support
in planning and administration.
Question. How long will it take to revitalize all state and local
jurisdictions so they are equally equipped to help stop the spread of
COVID-19 and other future disease outbreaks?
Answer. All state public health laboratories, and an increasing
number of county/local public health laboratories, have the potential
to perform next-generation sequencing. At the beginning of the
pandemic, the main limiting factors were (1) limited staffing; (2) the
large number of competing priorities in responding to the pandemic; (3)
a lack of bioinformatics capacity; and (4) limited experience and
knowledge among epidemiologic staff in how to use genomic data as part
of the response. With the long-term investments to strengthen public
health infrastructure as proposed in the fiscal year 2022 Budget,
including public health laboratories, we will be in a better position
to respond and control future outbreaks. With experience from COVID-19,
these organizations are already in a better position to apply genomic
epidemiology during the next public health emergency. But over the next
three to 5 years, with both the investments above as well as
investments in the sequencing Centers of Excellence (also supported by
the ARP funds) and large increases in training, state and local
jurisdictions will be in a much better position to apply genomics to
intervene at the start of a public health emergency.
Question. Thus far, the available COVID-19 vaccines protect against
most of the variants currently circulating. A group of biostatisticians
at Fred Hutchinson Cancer Research Center, based in Seattle, WA, are
studying breakthrough infections of COVID-19 following full vaccination
to determine which variants are able to evade the body's immune
response. By understanding the correlation between needed level of
protection and infection prevention, they hope to simplify the process
of booster shots or vaccines against new variants.
What other research or studies would the CDC conduct to make sure
the United States can quickly and proactively protect people from new,
and potentially more dangerous, variants?
Answer. CDC has monitored for variant viruses since the beginning
of the pandemic and continues to monitor for variants nationwide, in
support of ongoing efforts by the SARS-CoV-2 Interagency Group. We use
genomic information in combination with hospitalization and other case
and outcomes data to identify the spread of, and potential consequences
of, variants of concern.
CDC leads the National SARS-CoV-2 Strain Surveillance (NS3)
program, which identifies new and emerging SARS-CoV-2 variants to
determine implications for COVID-19 diagnostics, treatments, and
vaccines authorized for use in the United States. Genomic sequencing
allows scientists to identify SARS-CoV-2 and monitor how it changes
over time into new variants, understand how these changes affect the
characteristics of the virus, and use this information to better
understand how it might impact health. A notable strength of NS3 is the
regular collection of specimens from across the United States to
support variant characterization efforts, which provides important data
to inform public health decision-making.
Since January 2021, CDC has significantly increased domestic
genomic surveillance platforms to monitor circulating viruses. NS3 was
scaled up to process 750 specimens per week from public health
laboratories across the U.S. CDC also is contracting with large
commercial diagnostic laboratories to sequence samples. CDC has
commitments from these laboratories to sequence more than 20,000
samples per week, pending the availability of SARS-CoV-2 positive
specimens, with the capacity to scale up in response to the nation's
needs.
Since 2014, CDC's Advanced Molecular Detection Program has been
integrating next-generation sequencing and bioinformatics capabilities
into the U.S. public health system. Many state and local health
departments have been applying these resources as part of their
response to COVID-19. Public health departments support local
investigations, conduct studies, and make genomic data available to
public databases. To further support these efforts, on December 18,
2020, CDC released $15 million from COVID supplemental funds through
the Epidemiology and Laboratory Capacity Program.
In May 2021, CDC made available $240 million in American Rescue
Plan funds to state and local health jurisdictions through the
Epidemiology and Laboratory Capacity for Prevention and Control of
Emerging Infectious Diseases (ELC) cooperative agreement. These funds
are to be used over 3 years to build sequencing and analytic capacity
for all pathogens of interest, including SARS-CoV-2. In addition, CDC
plans to fund these state and local labs for at least an additional 3
years, with ARP funds, to continue and to build on these activities,
including funding support for equipment, supplies, and staffing. These
activities build on expertise gained by the Advanced Molecular
Detection (AMD) program since 2014 in the application of pathogen
genomics to public health.
Furthermore, we have issued 29 awards, totaling approximately $37
million, as part of the SARS-CoV-2 Sequencing for Public Health
Emergency Response, Epidemiology, and Surveillance (SPHERES)
Initiative. These awards are intended to fill knowledge gaps and
promote innovation in the U.S. response to the COVID-19 pandemic and
will help integrate next-generation genomic sequencing technologies
with bioinformatics and epidemiology expertise across the US public
health system.
As CDC and our public health partners sequence more SARS-CoV-2
genomes, we will continually improve our understanding of which
variants are circulating in the US, how quickly variants emerge, and
which variants are of most concern to public health, and thus the most
important to characterize and track.
Question. Is the CDC continuing to monitor other public health
concerns such as influenza?
Answer. Yes, CDC has continued to maintain and strengthen its
surveillance systems during the COVID-19 pandemic. For example, in
preparation for the 2021-2022 influenza season, CDC made several
enhancements to influenza surveillance systems, which improve detection
of influenza circulation and illness, to differentiate influenza from
COVID-19, and support COVID-19 surveillance. Data enhancements include
adding more than 1,000 emergency departments to the U.S. Outpatient
Influenza-like Illness Surveillance Network (ILINet), adding new data
sources from the National Long Term Care Facility Surveillance system
that reports data from approximately 15,400 facilities weekly, and
integrating HHS Protect hospital data from approximately 6,000
hospitals. Differentiation between influenza and COVID-19 is supported
by the CDC-developed multiplex assay for use by CDC-supported public
health laboratories, which simultaneously tests for type A and B
seasonal influenza viruses and SARS-CoV-2. These and other updates have
further strengthened the U.S. influenza surveillance system.
Question. I am alarmed by increasing antimicrobial resistance, and
the fact that high levels of antibiotic use during the COVID-19
pandemic have likely driven the development of new resistance threats
that have not yet been identified. The 2020-2025 National Action Plan
for Combating Antibiotic Resistant Bacteria calls for expanded efforts
that will only be possible with significant new Federal resources.
Addressing AMR is central to preparedness, as resistant secondary
infections complicate public health emergencies.
How does the President's Budget Proposal support the CDC Antibiotic
Resistance Solutions Initiative in fiscal year 2022 to expand efforts
to preserve the effectiveness of antibiotics, reduce inappropriate
antibiotic use, increase surveillance and ensure that we are prepared
to address this public health threat, as outlined in the 2020-2025
National Action Plan for Combating Antibiotic Resistant Bacteria?
Answer. The fiscal year 2022 President's Budget has $172 million
for the Antibiotic Resistance Solution Initiative, consistent with the
fiscal year 2021 appropriation. CDC is working to effectively leverage
resources and invest in key prevention strategies, such as early
detection and containment, infection prevention, and ensuring the
appropriate use of antibiotics. The availability of safe, effective,
and quality-assured antibiotics underlies much of modern medicine, and
the emergence and spread of AR threatens to undo this progress at
enormous human and economic cost.
COVID-19 has potentially created a perfect storm for antibiotic
resistance (AR) infections in healthcare settings, with longer lengths
of stay, crowding, severely ill patients, antibiotics frequently
prescribed upon admission, and infection control challenges like PPE
shortages. CDC supports a robust domestic infrastructure through its AR
Solutions Initiative to respond to emerging threats wherever they occur
across healthcare, the community, and the environment while building
key capacity to address AR internationally. CDC continues to use a One
Health approach to tackle AR and to gain a better understanding of AR
transmission, interactions, and impact between humans, animals, and the
environment.
CDC has also proposed ambitious plans to strengthen international
public health infrastructure as outlined in the 2020-2025 National
Action Plan for Combating Antibiotic-Resistant Bacteria (CARB). Over
the next 5 years of the plan, it proposes that CDC would establish two
networks--the Global Action in Healthcare Network and Global
Antimicrobial Resistance Laboratory & Response Network, which would
expand CDC's surveillance efforts globally.
Working together, these new global networks would enhance detection
and response to infectious disease threats internationally, and
implement prevention and containment strategies at local, national, and
regional levels. CDC also has proposed plans to expand surveillance of
AR threats in the environment, domestically and globally. These
activities would help to better understand resistance in the
environment, the connections between resistance in healthcare,
agriculture, and environmental settings, and its impact on human
health. CDC is piloting investments in these activities in fiscal year
2021.
Question. The COVID-19 pandemic laid bare the gaps resulting from
decades-long erosion of support for the public health workforce, which
did not have the people or resources needed to surge to meet the
demands of the emergency response. Strategic investments in a diverse,
robust, well-trained public health workforce at the community level are
critical to ensure that we are able to tackle local public health
challenges and be prepared for the next infectious disease outbreak.
President Biden's fiscal year 2022 budget proposal includes a request
for $106 million, a $50 million increase above fiscal year 2021, to
develop the next generation of essential public health workers.
How does CDC envision this proposed investment in fellowship and
training programs will translate in rebuilding the public health
workforce of epidemiologists, contact tracers, lab scientists,
community health workers, data analysts, behavioral scientists, and
communicators?
Answer. The COVID-19 response shone a stark light on deficiencies
in the nation's investment in its public health workforce, which did
not have the people or resources to surge to meet the demands of a
pandemic emergency response. Strategic investments in a diverse, well-
trained public health workforce are needed. CDC's fellowships and
training programs continue to supply a competent and sustainable
workforce capable of surging in response to imminent public health
threats.
CDC hosts approximately 300 fellows across seven fellowship
programs each year in 45 U.S. states and five territories. In fiscal
year 2021, all 137 EIS officers and Laboratory Leadership Services
(LLS) fellows contributed to the COVID-19 response, leading COVID-19
responses in their assigned states and publishing key findings in the
MMWR leading to actionable recommendations around mitigating the spread
of disease. CDC designs its fellowships and curricula to meet the
evolving needs of the public health workforce. A survey of human
resources directors identified the highest priority workforce needs as
epidemiologists, laboratory scientists, and public health informatics
specialists. CDC's fellowships are a pathway for training the next
generation of public health leaders.
Actions taken now to invest in developing the next generation of
essential public health workers will better position our communities
and the nation to respond to the current pandemic and to build back a
better workforce to safeguard Americans' health. With the fiscal year
2022 request of $106,000,000 for Public Health Workforce, CDC will
rebuild the workforce of epidemiologists, contact tracers, lab
scientists, community health workers, data analysts, behavioral
scientists, and communicators who can help protect America's health.
While health departments are the frontlines of emergency response,
Federal investment in workforce development is essential to a
coordinated national health workforce strategy. In fiscal year 2022 CDC
will:
--Expand the pathway of critical public health workers through
fellowship programs; assisting state, tribal, and local health
departments to conduct barrier assessments and implement best
practices for recruitment, hiring, and retention, and
publishing training materials for state, tribal, and local use
and STEM resources highlighting pathways to careers in public
health.
--Modernize workforce development information technology systems.
--Increase participants in CDC fellowship programs and place them in
areas of critical need.
CDC will invest in understanding barriers and facilitating
solutions around matching graduates in critical discipline areas with
positions serving local, tribal, and state communities. Developing
robust pathways to attract graduates to public health is essential to
future health security of the United States.
CDC will expand fellowship opportunities, from the Public Health
Associate Program to Epidemic Intelligence Officers. CDC will enhance
recruitment efforts and pave pathways for careers in public health at
the Federal, state, tribal, and local levels. Increasing the cohort of
EIS officers will provide critical applied learning and pathways for
the next generation of public health leaders. CDC will increase the
number of fellows in the field that provide essential assistance and
expertise to CDC and state, local, territorial, and tribal health
departments.
CDC will also strengthen the laboratory workforce to support
clinical and public health laboratory practice. Of the 800,000
laboratory professionals who work across 295,000 CLIA-certified
laboratories, less than 10 percent of the nation's clinical laboratory
professionals currently access CDC training and workforce development
resources. CDC will:
--Expand the reach of CDC's training and workforce development
resources beyond the public health laboratory community into
the broad clinical laboratory community, including those who
perform point-of-care testing, building critical bridges
between healthcare and public health.
--Continue data-driven development, promotion, and dissemination of
laboratory capacity- building initiatives and resources that
enhance the laboratory community's ability to combat emerging
threats, learn evolving practices, and stay current with the
newest standards and technologies
--Formalize partnerships to expand its reach and accessibility of its
training products and resources to the laboratory community
through its learning course syndication system.
--Expand development of its virtual reality training portfolio to
meet the evolving needs of laboratory professionals.
Question. How will state and local health departments benefit from
an expansion of these training programs?
Answer. With investment in CDC's fellowship and training programs,
CDC will rebuild the workforce of epidemiologists, contact tracers, lab
scientists, community health workers, data analysts, behavioral
scientists, and communicators who can help protect America's health.
These investments are essential to build a competent and empowered
public health workforce prepared to respond to future public health
emergencies. CDC will work with state, tribal, local, and territorial
health departments to rebuild the workforce and support these partners
to assist in hiring and recruitment; identify and address barriers to
hiring at the state and local levels; address workforce gaps; and build
capacity to respond to current and future public health threats. These
funds will support recruitment and training of public health leaders
through Epidemic Intelligence Services (EIS), Laboratory Leadership
Service fellowship programs, and Public Health Associate Program
(PHAP). They will complement other initiatives including:
--Public Health AmeriCorps, a new public health workforce program in
partnership with AmeriCorp, supported by investment from the
American Rescue Plan, will deploy a nationwide cohort of
workers, who will receive applied learning training and a
stipend in non-Federal term positions.
--Modernization of the public health workforce in which CDC will work
with public health leaders across Federal, state, local, and
territorial jurisdictions to create a new grant program to
provide under-resourced health departments with the support
they need to hire staff and build a public health workforce for
the future.
______
Questions Submitted by Senator Jeanne Shaheen
Question. Given that diabetes is one of the co-morbid conditions
that puts patients with COVID-19 at highest risk, I was pleased to see
CDC guidance that recommended prioritization of both Type 1 and Type 2
diabetes patients for vaccination. With 34 million Americans currently
living with diabetes, the economic cost of the condition now exceeds
$300 billion per year. Now more than ever, we need to do more to help
prevent Type 2 diabetes where possible and help people with diabetes
improve their management of the condition, so that we can see improved
outcomes.
How is CDC approaching the rapid growth in diabetes prevalence in
this country and what can we do in Congress to help?
Answer. CDC established the National Diabetes Prevention Program
(National DPP) to address the growing epidemic of type 2 diabetes. The
National DPP lifestyle change program is led by trained coaches who
facilitate participants' strategies for eating a healthy diet,
increasing physical activity, and developing coping skills. The
Diabetes Prevention Program clinical trial showed that participants who
engage in these lifestyle changes through a structured program can lose
five to 7 percent of their body weight and reduce development of type 2
diabetes by as much as 58 percent (71 percent for those 60 years of age
and older).
CDC supports state health departments and other stakeholder
organizations in expanding access to the National DPP for populations
at greatest risk for type 2 diabetes. Achieving insurance coverage is a
critical step for increasing access to this highly effective program.
Based on recipient reported data from September 30, 2018 to June 30,
2019, state health departments and other partners have secured health
insurance coverage for the National DPP for more than 1 million public
employees and their dependents in 24 states. In addition, the National
DPP lifestyle change program is currently a covered benefit for more
than 2.2 million private sector employees and their dependents across
21 states, a 61 percent increase from 2018. More than 1.4 million
Medicaid beneficiaries have the National DPP lifestyle change program
as a covered benefit, which includes participation from 30 states.
In March 2016, the Centers for Medicare & Medicaid Services (CMS)
certified the expansion of the National DPP into the Medicare program.
This was the first preventive service model from the CMS Innovation
Center to become eligible for expansion into the Medicare program--a
landmark for public health. The future of the MDPP as a covered service
will be determined by the outcome of the CMS Innovation Center's
expanded model evaluation. However, based on findings from the original
DPP research trial, subsequent translation studies demonstrating the
program's effectiveness in non-clinical settings, and the 15-year
results of the DPP Outcomes Study, this intervention has been studied
extensively and already has substantial evidence supporting its
effectiveness across settings and populations.
Question. Can you provide an update on CDC's investments in the
Division of Diabetes Translation (DDT) and the National Diabetes
Prevention Program (NDPP)? How is CDC measuring success for those
programs?
Answer. More than 550,000 people at high risk for developing type 2
diabetes have participated in the National DPP lifestyle change program
across the U.S. Evaluated participants have lost an average of 5.5
percent of their body weight. To date, there are almost 1,900 CDC-
recognized organizations offering the program in-person, virtual and
through distance learning. CDC aims to enroll 1 million participants
into the National DPP lifestyle change program by 2025.
Since the onset of the COVID-19 pandemic, a majority of the CDC-
recognized organizations are offering virtual (telehealth) options for
the National DPP lifestyle change program, an especially critical
feature to ensure participant safety. A 2017 study (Vadheim, L.M, et
al., 2017) found that participants who received the National DPP
lifestyle change program through telehealth videoconferencing (distance
learning) had similar rates of participation and achieved similar
weight loss as participants who attended the program in-person.
Through implementation of the National DPP, CDC aims to reduce the
number of adults newly diagnosed with type 2 diabetes. The national
rate of diabetes incidence (6.4 new cases per 1,000 adults in 2018) has
successfully moved below the Healthy People 2020 target (7.2 new cases
per 1,000 adults). The continued growth of the diabetes burden in terms
of absolute prevalence, lifetime risk, years spent with diabetes, and
the incidence rate remaining considerably higher than it was in the
1990s, are all contributing factors indicating a need for continued
prevention efforts like the National DPP.
Question. The COVID-19 pandemic has exacerbated challenges in our
response to the substance use disorder epidemic. As you know, the 2020
state-level CDC data on opioid overdose deaths will also dictate the
distribution of Federal opioid response dollars through the State
Opioid Response (SOR) grant program administered by the Substance Abuse
and Mental Health Services Administration (SAMHSA).
When does CDC expect to publish state-level data for 2020 on drug
poisoning deaths per capita? When CDC does publish the data, please
keep my office informed.
Answer. The National Center for Health Statistics provides
provisional drug overdose death data by state: Products--Vital
Statistics Rapid Release--Provisional Drug Overdose Data (cdc.gov).
Provisional data currently provides information on drug overdose deaths
occurring through October 2020. Final drug overdose death data for 2020
will be available in late 2021.
Question. Often there are discrepancies in state rankings on opioid
overdose deaths per capita compared to overall drug poisoning deaths
per capita. For instance, in examining CDC's WONDER data on 2018 opioid
overdose deaths per capita, as reported by the National Institute on
Drug Abuse (NIDA), compared to CDC's publication of 2018 overall drug
poisoning deaths per capita, New Hampshire ranks third in opioid
overdose deaths per capita and sixth in overall drug poisoning deaths
per capita. Will CDC publish data on opioid specific overdose deaths
per capita by state for 2020, as a supplement to its publication of
overall state-by-state drug poisoning deaths per capita in 2020?
Answer. Yes. In addition to drug overdose death data (including
deaths attributed to opioids) CDC provides analyses on final drug
overdose death data, including deaths related to prescription opioids,
heroin, synthetics opioids, and psychostimulants. CDC will update the
data once final 2020 overdose data are available.
CDC currently funds 47 states and the District of Columbia to
improve the timeliness and comprehensiveness of unintentional/
undetermined drug overdose mortality data. The State Unintentional Drug
Overdose Reporting System (SUDORS) captures detailed information on
toxicology, death scene investigations, route of administration, and
other risk factors that may be associated with a fatal overdose from
funded recipients. CDC continues to release analyses of data received
through this program. For example, CDC published a report describing
decedent demographic characteristics and circumstances surrounding
overdose deaths during January--June 2019 among 25 jurisdictions
participating in SUDORS, and it highlights the involvement of opioids
and stimulants, separately and in combination.
Question. I was pleased to see that the administration's budget
proposal calls for a continued commitment to efforts to defeat HIV in
this country. At the same time, we are also seeing significant
increases in the spread of sexually-transmitted diseases, including a
heartbreaking 40 percent increase in congenital syphilis passed from
mother to child during pregnancy in recent years. I have been concerned
that we have underfunded state and local STD prevention efforts for a
long time, which may impede our abilities to stop the spread of STDs.
Can you discuss how CDC is addressing growing rates of STD
infections, and congenital syphilis infections in particular?
Answer. CDC provides national leadership, research, policy
assessment, and scientific information about STDs to the medical
community and the public. CDC coordinates and publishes national STI
Treatment Guidelines and Recommendations, which translates research
into practice and serves as the gold standard for STI care in the
United States. Further, CDC supports health departments in all 50
states, Washington, D.C., and select cities and territories to conduct
core and essential STD prevention work through our flagship STD
prevention program, totaling $95.5million in 2020. CDC also has seventy
field staff embedded in state and local STD programs around the
country, who provide technical assistance and capacity building in
disease investigation to support communities and public health
partners, including investigating STDs in the community through field
testing, public health detailing, outbreak response, and contact
tracing.
COVID-19 mitigation necessitated innovative approaches to
delivering STD care that may prove to be valuable investments into the
infrastructure for STD care in the U.S. for years to come, including
(but not limited to):
--STD express clinics, which provide walk-in testing & treatment
without a full clinical exam
--Partnerships with pharmacies & retail health clinics, which can
provide new access points for STD services (e.g., on-site
testing and treatment)
--Telehealth/telemedicine, which can close gaps in testing and
treatment, ensure access to healthcare providers, support self-
testing or patient-collected specimens, and is especially
critical in rural areas
These strategies and more are outlined in HHS's first ever STI
Federal Action Plan, which provides a roadmap to develop, enhance, and
expand prevention and care programs at the national, state, tribal and
local levels over the next 5 years to reverse the course of the STD
epidemic.
Further, through its flagship STD prevention program, CDC supports
state and local public health departments to prioritize and strengthen
their efforts to eliminate congenital syphilis by matching syphilis
surveillance data with birth and mortality data and strengthening
congenital syphilis morbidity and mortality case review boards. On July
13, CDC funded four state STD programs, working in cooperation with the
state epidemiologist, to ensure that the implementation of congenital
syphilis projects prioritize sustainable system level or policy level
interventions in alignment with local epidemiology.
Finally, CDC is working diligently to support the Disease
Intervention Specialists (DIS) Workforce with funding from the American
Rescue Plan. For many years, DIS have provided invaluable support to
prevent and control STDs, tuberculosis, HIV, and other infectious
diseases. More recently, DIS were called to support the COVID-19
response, conducting case investigation and contact tracing in a
variety of community settings. CDC is making a $1.13 billion investment
over a five-year period to continue supporting the COVID-19 response
and other infectious disease prevention and response, by:
1. Expanding and enhancing frontline public health staff
2. Conducting DIS workforce training and skills building
3. Building organizational capacity for outbreak response
4. Evaluating and improving recruitment, training, and outbreak
response efforts
In addition to helping to contain and prevent COVID-19, we expect
that this cadre of culturally competent and experienced DIS will be
able to address STDs, such as congenital syphilis, as well as other
infectious diseases.
Question. In 2016, the New Hampshire Department of Health & Human
Services requested that the CDC's Agency for Toxic Substances and
Disease Registry (ATSDR) conduct health consultations for the public
water systems and private wells in the Merrimack-area of southern New
Hampshire after the discovery of per- and polyfluoroalkyl substances
(PFAS) contamination in drinking water. It is my understanding that
these health consultations remain ongoing, and I am concerned that
residents are still waiting and wondering about their exposure risks.
Can you provide an update on the status of these health
consultations and when you expect they will be concluded and released?
Answer. ATSDR continues to work on the private well and public
water health consultations. ATSDR received comments on the private well
health consultation from the state environmental department through our
data validation review process and is working to address those
comments. After the comments are addressed the document is reviewed
through CDC's clearance process, it will be released for public
comment.
In addition, ATSDR is currently completing a draft of the public
water health consultation and preparing for internal review and
clearance.
Question. The last thing firefighters should have to worry about is
the safety of the equipment they wear while in the line of duty. Yet
many active and retired firefighters are deeply concerned about
exposure to harmful PFAS chemicals from their protective gear. I was
proud to include my bipartisan Guaranteeing Equipment Safety for
Firefighters Act provisions in the fiscal year 2021 National Defense
Authorization Act (NDAA), which as you know, includes collaborative
efforts at the National Institute of Standards and Technology (NIST)
and National Institute for Occupational Safety & Health (NIOSH) to
study of the personal protective equipment worn by firefighters. I have
also worked through the Appropriations process to kick start this
research at NIST.
Can you discuss the CDC's current collaboration with NIST as they
work to identify a firefighter's relative risk of exposure to PFAS
released from their protective gear? How will NIST's study inform the
CDC's work--within both ATSDR and NIOSH--to better understand the
health effects of PFAS exposure?
Answer. CDC's collaborates with NIST, sharing information,
presentations, and collaborating on research activities such as
characterizing PFAS in turnout gear textiles. In 2021, NIST and NIOSH
provide overviews of PFAS activities and identified three topics for
further discussion, analytical and collection methodologies, selection
of and access to turnout gear textiles, and PFAS toxicity testing.
Meetings on these topics were conducted with smaller groups to help
facilitate targeted discussions.
NIST's research into PFAS in firefighter turnout gear is
anticipated to provide valuable information on potential exposures for
firefighters by identifying PFAS present in textiles and the conditions
contributing to the release of PFAS from said material. The analytical
methods included in NIST's study comprise a larger panel of PFAS than
is currently used in many studies of human exposure. Results from this
expanded panel will help guide future PFAS analyses of serum collected
from this occupationally exposed population as well as inform future in
vivo and in vitro studies of toxicity. When paired with studies of
dermal absorption and exposure assessments of firehouse air or dust,
NIST's research will also provide insight into the contribution of PFAS
from gear to a firefighter's total exposure, providing a more complete
understanding of the relevant pathways and routes of exposure in this
population.
NIOSH's National Personal Protective Technology Laboratory (NPPTL)
has been collaborating with NIST to determine which PFAS compounds are
on firefighter turnout gear and if they are released through
laundering. NPPTL collaborated with NIST, providing 20 different
textile swatches laundered using current fire service protocols. These
samples will undergo additional aging and stressing techniques to
measure PFAS release from textiles by NIST researchers.
NPPTL's comprehensive laundry study to identify and quantify the
individual PFAS compounds on firefighter textiles and to measure their
release through a series of washings, supplements the ongoing NIST work
. Additional NPPTL research studies the ability of PFAS compounds to
migrate through the 3-layered garment to be in direct contact with a
wearer's skin.
The NIST-NIOSH research collaboration will provide valuable
information regarding possible PFAS exposures related to firefighter
PPE and will yield time and monetary cost savings to both institutes.
Question. The Firefighter Cancer Registry Act, which was passed by
Congress and signed by the President in 2018, directed the CDC to
establish and maintain a voluntary National Firefighter Registry to
better understand the link between on-the-job exposure to toxic
substances and cancer in firefighters. The National Firefighter
Registry will be used to track and analyze cancer trends and risk
factors among firefighters. I have heard from firefighters in my state
interested in volunteering to participate. It is my understanding that
at this time, however, enrollment for the National Firefighter Registry
is not yet open.
Can you provide an update on the work being done to establish the
registry and a timeline of when it will be open for enrollment? When
the registry is opened for enrollment, will you work with my office to
provide information to active and retired firefighters about how to
participate if they so choose?
Answer. The National Firefighter Registry (NFR) has made
substantial progress in developing a rigorous scientific protocol,
enrollment questionnaire, and consent form. These documents have been
posted publicly at www.cdc.gov/niosh/bsc/nfrs. The enrollment
questionnaire has been submitted to OMB for review under the Paperwork
Reduction Act. The NFR program has also drafted an Assurance of
Confidentiality (AoC), which provides additional protection for
identifying information.
The NFR program has also made progress on the online NFR
Registration System. However, any public-facing data collection portal
must meet numerous Federal data security regulations and requirements--
some of which are relatively new and costly. NIOSH is working closely
with our IT and security specialists to ensure that the NFR
Registration System is compliant with these requirements. This has
extended the original timeline for the launching of the NFR. NIOSH also
recognizes that the registration system not only needs to be highly
secure, but also needs to be relatively easy for firefighters to
complete in order to maximize voluntary participation across the United
States.
The NFR team has been working closely with key scientific and fire
service stakeholders to determine the optimal design of the NFR
Registration System and what data must be collected. Launching of the
NFR Registration System is one step in many that will be needed over
the next several years to ensure the success of the program and meet
the requirements under the Firefighter Cancer Registry Act of 2018.
Once the NFR opens for registration, NIOSH will work with numerous
fire service organizations and other stakeholder groups to encourage
firefighters throughout the country, including career and volunteer,
active and retired, and firefighters with and without cancer, to enroll
in the NFR. The NFR team has developed a robust communications plan and
strong connections to fire service organizations such as the
International Association of Fire Fighters (IAFF) and National
Volunteer Fire Council (NVFC), which are the two largest organizations
representing career and volunteer firefighters, respectively. We
welcome opportunities to work with congressional offices to reach
firefighters within your state or district.
Question. Can you discuss how you expect this epidemiological
information and analysis will help public safety officials,
researchers, scientists and medical professionals find better ways to
protect those in the fire service?
Answer. The enrollment questionnaire will serve as the primary data
collection instrument when firefighters initially register collecting
information about work history (including large or unusual responses),
implementation of control measures, family history of cancer, and
healthy behaviors. The questionnaire will also ask for identifying
information, such as name and date of birth, which can be used to make
linkages to state cancer registries. Collecting identifying information
will allow NIOSH to periodically link to existing cancer diagnosis
databases to detect new cases of cancer long-term that may not have
been reported.
Additional follow up questionnaires will allow for analysis of
specific workplace factors as well as topics of special interest to the
public safety community. The NFR program also plans to work with fire
departments to capture fire and incident information to build an
exposure profile for the NFR participants. Over time and with broad
participation, all this data can be used to better understand the
amount and types of cancer among firefighters; the prevalence of cancer
risk factors and healthy behaviors among firefighters; and the
relationship between firefighter cancer and workplace characteristics,
exposures, and practices. We will explore cancer risk among
understudied firefighter groups including women, minorities,
volunteers, and firefighters in sub-specialty assignments like wildland
firefighters or fire-cause investigators. We will also evaluate how the
adoption of certain control measures, like routine laundering of
turnout gear, affects cancer risk. These analyses will help scientists
at CDC/NIOSH identify the most important factors associated with
firefighters' risk of specific types of cancer, including rare forms of
cancer. Results can then be used by public safety officials to
implement new evidence-based policies or procedures to reduce
firefighters' cancer risk. Medical professionals will also have more
knowledge about the types of cancer that are most elevated among the
different groups of firefighters, which could assist them in providing
advanced screening and healthcare for firefighters.
______
Questions Submitted by Senator Joe Manchin, III
Question. The Food and Drug Administration reports that nearly 40
percent of finished drugs and roughly 80 percent of active
pharmaceutical ingredients are manufactured abroad. During the COVID-19
pandemic we saw factories shut down in order to prevent spread of the
virus, drug supply chains disrupted, and drug shortages increase. As a
result American's access to essential medicines was put into jeopardy.
To avoid future shortages of essential medicines, domestic
manufacturing is key to shoring up our supply chain.
How important is a strong domestic supply chain for essential
medicines?
Answer. Ensuring a safe and consistent public health supply chain
for medical materials, ingredients, and supplies is critical for any
national response to public health emergencies.
Question. How can we ensure we don't experience future drug
shortages when global supply chains are disrupted?
Answer:
--Investments in securing the industrial base and domestic supply
chain require dedicated and persistent management and
engagement.
--Throughout the COVID-19 response, ASPR has leveraged the
authorities delegated to the Secretary under the Defense
Production Act (DPA) to issue 62 priority ratings for United
States Government (USG) contracts for health resources, eight
priority ratings for USG contracts for industrial expansion,
three priority ratings for non-USG contracts to support the
production of resins for both diagnostics and infusion pumps,
and the manufacture of closed suction catheters for treatment
of patients with COVID-19--all to ensure private sector
partners making life-saving products are able to acquire the
raw materials, components, and products requisite to deliver
for the response.
--Also under the DPA, ASPR is strengthening the industrial base to
secure and develop domestic capacity, retool and expand
industry machinery, scale production facilities, train
workforces, and ultimately infuse the supply chain and
marketplace with products the US needs to contain further
pandemic waves. ASPR continues to invest in critical funding in
expanding domestic manufacturing including investments of: $250
million in manufacturing PPE; $268 million in manufacturing of
testing consumables; $14.8M in vaccine raw material
manufacturing; $160 million in fill finish capacity; $65
million in vaccine vial manufacturing; $168 million in
manufacturing capacity for at home and point of care tests;
and, $53.8M in testing raw materials. Each of these domestic
manufacturing initiatives meets current, as well as future
COVID-19 needs, and seeks to create or sustain high-value
domestic jobs.
Question. Last week, the CDC announced $7.4 billion from the
American Rescue Plan to support the public health workforce and the
response to the COVID pandemic. This funding included $2 billion for
state health departments. This will go a long way to shoring up our
public health workforce as you outlined, in particular the requirement
for at least 40 percent of the funding to support local hiring through
local health departments or community-based organizations. West
Virginia led the country in vaccination rates in large part due to our
local health departments and health centers across the state
establishing Local Leadership Planning teams to roll out vaccination
plans in all 55 counties. These teams are multisector,
multidisciplinary local health leaders. They know their communities,
and have stepped up to respond to this virus.
In addition to this funding, what is CDC doing to support local
initiatives like West Virginia's Local Leadership Planning teams?
Answer. Partnerships and trusted community members have been
critical to reaching communities disproportionately affected by the
pandemic. Community health workers (CHW) are frontline public health
workers who have a trusted relationship with the community and are able
to facilitate access to a variety of services and resources for
community members. Scaling up and sustaining a nationwide program of
CHWs who support populations hit hardest by COVID-19 is critical. In
addition to the $7.4 billion to support the public health workforce
awarded from the American Rescue Plan, CDC also plans to provide $300
million to jurisdictions for CHW services to support COVID-19
prevention and control. CDC plans to provide an additional $32 million
for training, technical assistance, and evaluation. CDC expects to
award funds to approximately 75 organizations through the ``Community
Health Workers for COVID Response and Resilient Communities.'' Notices
of awards will be issued in the summer, with the amount each
jurisdiction receives determined by population size, poverty rates, and
COVID-19 statistics.
CDC also provided funding with specific guidance to focus on
reaching disproportionately affected communities, including:
--$3 billion to strengthen vaccine confidence (awarded early April
2021): Funding focuses on reaching 64 communities hit hardest
by the pandemic, including those in rural areas, to ensure
greater equity and access to vaccine and expand COVID-19
vaccine programs. To ensure health equity and expanded access
to vaccines, 75 percent of funding must focus on specific
programs and initiatives intended to increase vaccine access,
acceptance, and uptake among racial and ethnic minority
communities, and 60 percent must go to support local health
departments, community-based organizations, and community
health centers.
--$3 billion in cooperative agreements to support broad-based
distribution, access, and vaccine coverage (awarded Jan. 2021):
A minimum of 10 percent to jurisdictions must be allocated for
high-risk and underserved populations, including rural
communities.
--75 percent of the total funding must focus on specific programs
and initiatives intended to increase vaccine access,
acceptance, and uptake among racial and ethnic minority
communities; and,
--60 percent must go to support local health departments,
community-based organizations, and community health
centers.
--$2.25 billion in grant funding to states and localities
(anticipated to be awarded June 2021) to address COVID-19 in
high-risk and underserved communities, including rural
communities and communities with large populations of racial
and ethnic minorities. Recipients are strongly encouraged to
collaborate with and provide funding and resources to reach
organizations such as community-based and civic organizations,
faith-based organizations, non-governmental organizations, and
state offices of rural health or their equivalent such as state
rural health associations.
Question. How can we maintain local efforts like these to ensure
they continue to operate after the public health emergency?
Answer. CDC must build on initial investments and lessons learned
from COVID-19 with sustained, flexible investments in the nation's
public health infrastructure as proposed in the fiscal year 2022
Budget. This work must include public health workforce development, as
well as public health data modernization and epidemiology and
laboratory capacities, so that we can address the broader public health
consequences of the pandemic such as opioids, injuries, violence,
immunization, and chronic disease control. It will also help us prepare
for the future, because there are and will be more public health
threats.
Question. Just last week the CDC updated its guidelines in regards
to people who have been fully vaccinated. One guideline has caused
confusion in my state, specifically in regards to reporting and the
quarantining of people who have been vaccinated with a known exposure
to COVID. Currently, the guidelines require a fully vaccinated person
to quarantine for 10 days only if they develop symptoms. However, there
does not appear to be a clear reporting requirement for persons who
have been exposed and develop minor symptoms. Nor is there flexibility
for a fully vaccinated person to quarantine for a shorter period of
time if their symptoms disappear. Tracking these breakthrough cases is
important to ensure we know if and when a booster may be needed to
ensure protection for our population, and tracking potentially
problematic COVID variants.
How does the CDC plan to effectively monitor breakthrough cases?
Answer. The goal of national surveillance for COVID-19 vaccine
breakthrough infections is to identify unusual patterns, such as trends
in age or sex, the vaccines involved, underlying health conditions, or
which of the SARS-CoV-2 variants made people sick. To date, CDC's
monitoring of breakthrough cases shows there are no unusual patterns in
cases that have been detected in the data CDC has received. Despite the
high level of vaccine efficacy, it is expected that a small percentage
of fully vaccinated persons will develop symptomatic or asymptomatic
infections (i.e. breakthrough infections) with SARS-CoV-2, the virus
that causes COVID-19.
Vaccine breakthrough surveillance focuses on those cases resulting
in hospitalization or death. CDC coordinates with state and local
health departments to investigate vaccine breakthrough cases and
identify patterns or trends. Health departments report breakthrough
cases to CDC on a voluntary basis. However, it is important to note
that tracking and publicly reporting vaccine breakthrough via national
surveillance is just one way CDC measures vaccine effectiveness. CDC is
leading multiple vaccine effectiveness studies, some of which include
information on vaccine breakthrough infections, to ensure COVID-19
vaccines are working as expected. Through these studies in various
populations, locations, and settings, CDC can obtain more
representative, scientifically valid, and complete information about
these types of infections.
CDC is also using the Coronavirus Disease 2019 (COVID-19)-
Associated Hospitalization Surveillance Network (COVID-NET) to track
and analyze breakthrough infections. This population-based surveillance
system includes data on laboratory-confirmed COVID-19- associated
hospitalizations in 99 counties in 14 states, representing
approximately 10 percent of the U.S. population. COVID-NET cases are
hospitalizations occurring in residents of a designated COVID-NET
catchment area who are admitted within 14 days of a positive SARS-CoV-2
test. COVID-NET personnel collect COVID-19 vaccination status (doses,
dates administered and product) from state Immunization information
systems (IIS) for all sampled COVID-NET cases in 13 sites, which also
include information on clinical outcome. Some sites have expanded
collection of vaccination status to non-sampled cases, which were
included for analysis if all cases in a single month had vaccination
status available.
Question. Is the CDC considering reducing the required isolation
period for fully vaccinated persons after their symptoms disappear?
Answer. CDC data indicates that vaccinated people are less likely
to contract COVID-19 and are much safer from having serious outcomes if
they do contract it. If they become infected, they can spread the virus
to others. Moreover, if the infection is caused by the Delta variant,
based on what we know at this time, they can likely spread it as easily
as unvaccinated people who are infected, at least initially. As
infection progresses, vaccinated persons with COVID-19, including
COVID-19 caused by the Delta variant, appear to be infectious for a
shorter period of time than infected unvaccinated people.
CDC is reviewing all the emerging evidence and will continue to
monitor the data on duration of infectiousness for breakthrough cases.
Throughout the pandemic, CDC has updated guidance to reflect the latest
available information about COVID-19 and would consider changing
recommendations for isolation periods for vaccinated people who have
breakthrough infections if the accumulating science indicates such a
change were both safe and reasonable.
Question. As you are aware we are facing an epidemic within a
pandemic. West Virginia is ground zero for the drug epidemic, with the
highest rate of drug overdose deaths in the country. To make matters
worse, 2020 was the worst year for drug overdoses, with over 90,000
deaths. West Virginia saw at least a 47 percent increase in overdose
deaths last year. The drug epidemic has led to a sharp increase in
opioid-related infectious diseases, including HIV and viral hepatitis.
This has stretched the resources of our public health departments and
health providers even further.
What resources is the CDC providing to states to combat this
epidemic?
Answer. CDC is providing resources to states through Overdose Data
to Action (OD2A), a cooperative agreement that began in September 2019.
It combines strategies from previous surveillance and prevention
funding agreements to address the complex and changing nature of the
drug overdose epidemic. Through OD2A, 47 states, Washington D.C., 16
localities, and two territories are receiving almost $300 million in
funding.
CDC is also addressing the infectious disease consequences of the
opioid epidemic. Nearly $13 million of combined fiscal year 2019 and
fiscal year 2020 funding was awarded through the Infectious Disease and
the Opioid Epidemic initiative to state and local health departments
and national organizations to address the infectious disease
consequences of drug use.
In light of the COVID-19 pandemic, CDC has worked to provide
flexibilities to the 66 grantees by extending the funding for an
additional year and providing additional guidance and assistance as
needed. We have also engaged grantees to identify innovative ways to
respond during the pandemic. We are also using COVID-19 funding to:
--Understand how substance use patterns and attitudes among youth
have changed due to COVID-19 and disseminate tailored public
health messaging and interventions to help address increased
substance use during this period of time and prevent
detrimental long-term consequences.
--Identify innovative harm reduction practices to assess the extent
to which these strategies can be sustained and scaled. CDC
plans to summarize these strategies and disseminate them to
state, local, and Federal partners.
In addition, CDC is Combating Opioid Overdose Through Community-
level Intervention Initiatives (COOCLI). CDC, through its Opioid
Response Strategy partnership, provided funding to the Office of
National Drug Control Policy to create public health/public safety
interventions at the local level. COOCLI sub-awards funded pilot
programs to implement innovative, evidence- based, community-level
interventions.
Question. Is the CDC working on helping increase testing for viral
hepatitis and HIV as well as linking patients to care?
How can CDC help improve testing and surveillance of opioid-related
infectious diseases with our current substance use treatment programs
and recovery facilities?
Answer. Our nation has seen steady increases in infectious
diseases--including viral hepatitis and HIV--among people who use drugs
since the start of the opioid crisis over a decade ago. Making testing
for viral hepatitis and HIV accessible, convenient, and routine is
critical, especially in populations disproportionately affected by
these diseases, including people who inject drugs (PWID). CDC developed
programs to increase infectious disease testing among PWID and
continues to invest in these programs through state and local health
departments and through community-based organizations. Specifically,
CDC is focusing investments on scaling up HIV self-testing--like the
Take Me Home self-testing program that provides free HIV self-tests--
making HIV screening a regular part of healthcare, and delivering viral
hepatitis and HIV testing in non- traditional settings, such as
correctional facilities and syringe services programs (SSPs).
As viral hepatitis, HIV, and substance use disorders continue to
impact communities throughout the United States, CDC is not only
increasing support for testing, but also diagnosis, linkage to care,
and treatment. CDC is also improving implementation of and access to
high-quality SSPs across the country, where legal, through
dissemination of best practices and providing technical assistance.
CDC's core Integrated HIV Surveillance and Prevention for Health
Departments program (PS18-1802) supports the implementation of
comprehensive SSPs as part of a key community-level HIV prevention
strategy. In addition, CDC's National HIV Behavioral Surveillance
system collects important data among persons at high risk for HIV
infection, including persons who inject drugs. These programs work to
ensure the provision of high-quality, comprehensive harm reduction
services, which include testing for infectious diseases, linking
patients to opioid use disorder treatment, and providing infectious
disease care for clients of syringe services programs.
In addition to testing and treatment for infectious diseases, CDC
works to increase linkage to substance use disorder treatment within
SSPs and during healthcare encounters for PWID.
Question. The COVID-19 pandemic has revealed public health data
infrastructure shortcomings within both our Federal and state
institutions. West Virginia's response to the COVID-19 pandemic,
however, shows our ability to adapt in times of crisis. In addition to
the strong leadership of our National Guard, our local health
information exchange stepped up to track important health data, such as
hospitalization and vaccination rates, demographic data, and much more.
Most importantly, our health information exchange helped us build out
systems so that West Virginia health providers were able to fully
utilize the CDC's Vaccine Administration Management System (VAMS). As
outlined in President Biden's national strategy, we need improved
systems for public health data exchange and surveillance. This will
allow us to better track outbreaks, testing, vaccination rates and much
more.
How will you ensure Federal investments into public health data
will support data sharing between public health and healthcare
delivery, such as the West Virginia's health information exchange?
Answer. The success of CDC's Data Modernization Initiative (DMI) is
critical for our nation's response to COVID-19 and beyond. Improving
data sharing between public health and healthcare delivery is key to
realizing the full potential of public health data modernization.
Monitoring and evaluation are how we make sure we are delivering on the
promise of data to protect America's health. The need for modernization
never stops. Within DMI, we are monitoring progress on a growing suite
of modernization projects. These investments touch nearly every part of
the public health data ecosystem.
All of CDC's data modernization investments are guided by a Roadmap
of Activities and Expected Outcomes that guides all current and future
investments in data modernization. This strategic roadmap lays out our
priorities and keeps our end goals in front of us. It ensures work
going on through any given stream ties into and benefits the others--
and that we are moving toward the same definition of success. The
roadmap is the basis for our DMI monitoring and evaluation framework.
Robust monitoring and evaluation will maximize our impact on public
health. This is where we track our progress consistently and
scientifically to see what our investments have produced. We can also
see which solutions are working well and which may need additional
support to reach their goals.
Electronic case reporting (eCR) has demonstrated success in
improving data sharing between public health and healthcare. eCR is the
automated, real-time exchange of case report information between
electronic health records (EHRs) and public health agencies for review
and action. It moves data quickly, securely, and seamlessly from EHRs
in healthcare facilities to state or local health departments. All 50
states, D.C., and 11 large local jurisdictions are now capable of
receiving COVID-19 electronic case reports, up from only a handful of
jurisdictions in late 2019. As of May 15, more than 8.1 million COVID-
19 reports have been sent to 61 public health agencies and more than
7,900 healthcare facilities in all 50 states can send COVID-19
electronic case reports. There are currently 236 facilities in West
Virginia actively using eCR, including West Virginia University.
CDC is actively working to expand the number of healthcare
organizations implementing eCR and support public health agencies to
fully use the case reports within their data ecosystem. This includes
collaboration with healthcare systems, EHR vendors, and with the Office
of the National Coordinator for Health Information Technology (ONC) to
improve exchange of health information.
Question. Will you work with state partners like WVU Health
Sciences to continue to improve data analytics?
Answer. Support and engagement with partners to improve data and
analytics is an important component of the CDC Data Modernization
Initiative (DMI). Data modernization requires an ongoing commitment and
partnership across the public health sector--and especially with our
state, tribal, local, and territorial partners. CDC will continue to
support and engage with partners to improve data collection,
interoperability and data analytics. CDC is working closely with public
health partners to provide technical assistance focused on:
--Developing interoperable data systems to reduce the burden on
healthcare systems, facilities and laboratories that report
critical data to jurisdictions
--Increasing the overall efficiency of public health data systems at
the state level
CDC also supports public health partners like the Association of
Public Health Laboratories (APHL) and the Council of State and
Territorial Epidemiologists (CSTE). These partners are providing
technical assistance to jurisdictions focused on improving data
sharing, accelerating use of shared decision support services, data
science upskilling of the public health workforce, and developing and
increasing use of standards to improve quality and timeliness of
reported data.
______
Questions Submitted by Senator Roy Blunt
Question. Dr. Walensky, several of the COVID-19 vaccine developers
have indicated we may need a vaccine booster. To that end, BARDA
notified an intent to purchase 400 million doses of COVID-19 vaccine
from Moderna and Pfizer for $7.9 billion on May 2nd as booster shots.
Was that the right decision? Because many public health experts
indicate, including former CDC Director Tom Frieden, that there is
growing evidence that a first round of global vaccinations may offer
enduring protection. What is your opinion here? What I think could be
very dangerous is if vaccine companies, rather than public health
experts, are setting the public's expectations around COVID-19
boosters.
Answer. CDC will update its recommendations on re-vaccination or
additional doses of COVID-19 vaccines when additional information is
available. CDC is closely collaborating with Federal partners and the
global science and public health community to determine next steps on
COVID-19 vaccine boosters. Currently, there is not enough data to
support recommending boosters.
Question. Adult immunization programs are not typically done well
in the U.S.
Should we face the prospect of COVID-19 boosters next year, what is
CDC doing now to plan for that possibility?
Answer. CDC will update its recommendations on re-vaccination or
additional doses of COVID-19 vaccines when additional information is
available. CDC is closely collaborating with Federal partners and the
global science and public health community to determine next steps on
COVID-19 vaccine boosters. CDC works continuously with our state and
local immunization programs to strengthen their capacity to deliver
vaccines, monitor their safety and effectiveness and address identified
gaps.
The fiscal year 2022 budget request includes nearly a $100 million
increase to expand existing efforts to enhance the adult immunization
infrastructure to increase routine vaccination rates, detect and
respond to outbreaks of VPDs, and address vaccine hesitancy. Adult
immunization program funding will build on recent investments in the
COVID-19 vaccine program to support essential activities aimed at
strengthening the safety net for uninsured adults, addressing
disparities in adult vaccine coverage, and supporting vaccine efforts
across the lifespan.
Question. Will you try to team other adult vaccinations with the
COVID vaccination?
Answer. COVID-19 vaccines were previously recommended to be
administered alone, with a minimum interval of 14 days before or after
administration of any other vaccines. This was out of an abundance of
caution and not due to any known safety or immunogenicity concerns.
However, substantial data have now been collected regarding the safety
of COVID-19 vaccine currently authorized by FDA for use under Emergency
Use Authorization. Although data are not available for COVID-19
vaccines administered simultaneously with other vaccines, extensive
experience with non-COVID-19 vaccines has demonstrated that
immunogenicity and adverse event profiles are generally similar when
vaccines are administered simultaneously as when they are administered
alone.
COVID-19 vaccines and other vaccines may now be administered
without regard to timing. This includes simultaneous administration of
COVID-19 vaccine and other vaccines on the same day, as well as
coadministration within 14 days. When deciding whether to co-administer
vaccine(s) with COVID-19 vaccine, vaccination providers should consider
whether the patient is behind or at risk of becoming behind on
recommended vaccines, their risk of vaccine-preventable disease (e.g.,
during an outbreak or occupational exposures), and the reactogenicity
profile of the vaccines.
Question. There are reports, many of which the CDC has published,
highlighting the toll this pandemic has had on our nation's public
health. And there's an increasing number of reports that the overall
health of Americans has suffered as a result of the pandemic. It is
increasingly evident that in the coming months, as we emerge from under
the shadow of this pandemic, existing and emerging public health
challenges will have to be addressed.
How are you planning to address these challenges and how does the
fiscal year 2022 budget reflect those needs?
Answer. CDC is committed to upgrading the public health system so
the nation is ready for whatever may come next by building on
investments and lessons learned during the pandemic. Key priorities
include modernizing our public health data systems, supporting a
diverse and skilled public health workforce, enhancing laboratory
capacity, and promoting global health security. We now know that long-
term and flexible funding--as proposed in the fiscal year 2022 budget--
will be required to sustain improvements and address broader
consequences of the pandemic and historical underinvestment in areas
like health equity, opioid use and misuse, injuries and violence,
immunization planning, and hypertension control.
Question. What are the areas where this budget request may fall
short--perhaps because we're only just beginning to understand the vast
impact of the pandemic in areas such as chronic conditions, delayed
care and immunizations, or reemerging infectious diseases, such as STDs
and hepatitis?
Answer. The nation's public health system has not recovered from
the economic downturn in 2008, which resulted in significant reductions
in public health staffing at the state and local level. Similarly, CDC
has become increasingly reliant on infusions of supplemental funds to
address specific health crises. Building back a robust public health
infrastructure will take sustained investments over time to address
both foundational needs like data, lab capacity and workforce as well
as strategic investments to address health equity and social
determinants of health. The fiscal year 2022 President's budget
includes request for increased funding needed to address some of the
consequences of the pandemic including mental health, opioids, and
prevention of chronic and infectious diseases.
Question. Conversely, our nation has made great strides these last
several months against the COVID pandemic and we've gained a greater
understanding as to what is needed for a robust public health system--
from the public health laboratories to health statisticians and
academic researchers to private enterprise--advancements have been made
across the board.
How does the fiscal year 2022 budget request account for the
lessons learned over the last year to improve our public health
infrastructure?
Answer. The ability to respond to a public health emergency
requires a strong day-to-day public health system, supported by
infrastructure that is not highly segmented by disease, condition, or
activity. In addition to the COVID-19 pandemic, over the past 24
months, CDC has also responded to diverse public health threats from E-
cigarette or Vaping Product Use-Associated Lung Injuries (EVALI),
Ebola, complex multi-state food-borne disease outbreaks, wildfires, and
hurricanes. Responding to the unique characteristics of each of these
public health emergencies has required deep scientific expertise to
deploy a specialized approach and called for a robust public health
system with world-class infrastructure nationwide to stop disease at
its source. Unfortunately, this recent history has revealed the effects
of inadequate public health infrastructure. Ongoing health disparities
made us as a nation more vulnerable to pandemics and large-scale public
health emergencies, as well as burdening large segments of our
population with chronic public health concerns. Additional investment
in both domestic and global public health infrastructure is needed as
requested in the fiscal year 2022 Budget.
With investments requested in fiscal year 2022, CDC will begin to
address mission-critical gaps in public health infrastructure and
capacity nationwide. Transitioning from sporadic influxes of
supplemental funding tied to a specific emergency to flexible funding
that can prevent another crisis will strengthen the current public
health system. Flexible, sustainable investments in infrastructure and
capacity are critical for saving lives and averting economic losses
caused by public health emergencies and chronic public health problems.
In fiscal year 2022, CDC will prioritize funding to rebuild the most
critical public health infrastructure needed to safeguard the nation's
health and economic security.
Question. The budget includes $400 million for Public Health
Infrastructure Capacity.
How does this request account for the flexibility needed to scale
certain functions or respond in the future to a wholly different public
health threat?
Answer. CDC will expand its ability to leverage public health
infrastructure to address emerging and longstanding issues by providing
direct funding for capacity-building resources, guidance, and
collaboration to states, localities, and territories. These resources
will be disease-agnostic investments in core public health
infrastructure and capacity to expand programs and systems that address
long-standing public health issues and support public health response.
Question. How, specifically, will this $400 million be divided
between the different activities outlined in the budget?
Answer. This investment must be flexible, stable, and keep pace
with inflation and technological advancements in order for states,
localities, and territories to address their most urgent needs, such
as: a diverse, data-savvy workforce with secure funding that attracts
the best talent to public health; robust technological infrastructure
that is nimble and scalable; innovations and collaborations with
multiple sectors; and programs that address disparities during and
after the COVID-19 pandemic.
Question. Unfortunately, there is no question that the pandemic has
been challenging for many people--our nation has faced an unprecedented
mental health crisis and a rise in overdoses. CDC's provisional data
shows a 28 percent increase in overdose deaths in the 12-month period
ending in October 2020. More than 88,000 lives were lost to an overdose
during that period, the highest number of fatal overdoses ever recorded
in the U.S. in a single year, three-quarters of which were opioid-
related. Throughout my time on this Subcommittee, I made it a priority
to combat the opioid crisis and I'm concerned we have suffered a
significant setback. We need to better understand the impact that the
pandemic has had on overdoses and substance abuse.
What can you say about these trends in fatal overdoses and what are
some of the immediate needs to combat them?
Answer. Provisional 2020 data reveal that over 93,000 people died
of an overdose in 2020, a nearly 30 percent increase over 2019. The
recent increase in drug overdose mortality began in 2019 and continued
into 2020, prior to the declaration of the COVID-19 National Emergency
in the United States in March.
There are many factors that can be driving the increase in overdose
deaths including:
--The changing illicit drug marketplace and the wider availability of
illicitly manufactured fentanyl and fentanyl analogs,
--Co-use of illicitly manufactured fentanyl with other drugs such as
cocaine and methamphetamine, and
--Mixing of illicitly manufactured fentanyl into the drug supplies of
methamphetamine and cocaine
CDC's Overdose Data to Action (OD2A) funds health departments in 47
states, the District of Columbia, two territories, and 16 cities and
counties to obtain high-quality, comprehensive, and timely data on
fatal and nonfatal drug overdoses to inform prevention and response
efforts. To help curb this epidemic, Overdose Data to Action strategies
focus on enhancing linkage to and retention in substance use disorder
treatment, improving prescription drug monitoring programs,
implementing post-overdose protocols in emergency departments,
including naloxone provision to patients who use opioids or other
illicit drugs, and strengthening public health and public safety
partnerships, enabling data sharing to help inform comprehensive
interventions.
The President's Budget for fiscal year 2022 includes a requested
increase of $237.8 million for opioid overdose prevention and
surveillance. Immediate needs to combat the acceleration in overdoses
include:
--Expanding the provision and use of naloxone and overdose prevention
education;
--Expanding access to and provision of treatment for substance use
disorders;
--Intervening early with individuals at the highest risk for
overdose; improving detection of overdose outbreaks due to
fentanyl, novel psychoactive substances (e.g., fentanyl
analogs), or other drugs to facilitate an effective response;
--Continued partnerships with public safety to monitor trends in the
illicit drug supply, including educating the public that drug
products might be adulterated with fentanyl or fentanyl analogs
unbeknownst to users.
A comprehensive and coordinated approach from clinicians, public
health, public safety, community organizations, and the public must
incorporate innovative and established prevention and response
strategies, including those focused on polysubstance use.
Question. The Labor/HHS bill provides funding for opioid-related
programs at the CDC, and a particular area of focus addresses
infectious diseases associated with the opioid epidemic. Those
resources help strengthen our understanding of the full scope of the
burden of infectious diseases associated with substance use disorders.
As a result of the pandemic, many public health departments' staff that
would normally work on surveillance and prevention of infectious
diseases, such as hepatitis, have been detailed to work on the COVID
response.
What do we know about the impact of the pandemic on surveillance
and prevention of infectious diseases associated with the opioid
crisis?
Answer. The COVID-19 pandemic has deepened the opioid crisis and is
having a profound impact on the fight against infectious diseases
associated with this epidemic. We don't yet know the full impact but we
are concerned that the major disruptions in access to prevention
services and deferral of healthcare services during the pandemic may
result in more infections and lead to severe health consequences in the
long run. Deferral of healthcare services ultimately delays diagnosis
and treatment, leaving people living with Hepatitis C and/or HIV
unaware of their status and vulnerable to disease progression while
also increasing the risk of spreading the viruses. Available data from
CDC's funded programs also indicates that 50 percent of syringe
services programs (SSPs) have reduced operations and 25 percent have
closed further impacting opportunities for hepatitis testing and
linkage to care. The closures of these SSPs severely limited access to
vital hepatitis C virus and HIV prevention services, including
referrals to treatment services as well.
In October 2020, CDC released a health advisory about the
possibility of new injection-related HIV infections and outbreaks and
noted how prevention efforts could be hindered because of the COVID-19
pandemic. Many HIV and viral hepatitis program staff were reassigned to
support the COVID-19 response which further hindered prevention
efforts. In the context of the pandemic, ongoing delivery of core
public health services to address the injection drug use crisis and the
infectious diseases associated with this epidemic, like hepatitis C and
HIV are essential. CDC is committed to helping states build capacity to
combat both epidemics and will continue to provide guidance as we
address new and evolving challenges.
Question. In response to the COVID pandemic, states have received
billions of dollars in aid, with the intent of giving them maximum
flexibility to respond to their unique needs and challenges. Congress
passed five bipartisan emergency supplemental funding bills last year,
four of which included funding specifically for CDC activities totaling
$16.25 billion for the agency. The vast majority of the funding,
roughly 75 percent, is to support state and local public health
preparedness and response, laboratory capacity, and surveillance. It is
my understanding there is a sizable portion of unobligated funds
remaining from the bipartisan emergency supplemental bills. And now
there is even more funding provided as part of the American Rescue Plan
reconciliation bill for the same purpose. While it is important to know
how fast CDC is getting this funding into the hands of the frontline
responders on the state level, it is just as important to know if
they're spending the money.
What are the spend rates that CDC is seeing at the state level?
Answer. States have multiple funding sources, including
disbursements from the treasury, that are used for public health
purposes. The amounts and purposes vary greatly by state and it is not
possible to generalize about spend rates. Recipient cash drawdowns are
a lagging indicator of recipient performance because the recipient
draws down cash to reimburse at the time of, or after, they pay their
bills. In addition, as recipients have their own project plans and cash
management processes, cash drawn totals provide a high-level picture
for that recipient and are generally not comparable across a cohort of
recipients in the same program.
Question. What accountability do the States have to tell you how
they have used the funds?
Answer. Recipients regularly report on their use of funds and the
outcomes they achieved per the terms of the funding agreement by which
they are awarded the funds.
Question. Given the unprecedented volume of funding going out from
the CDC as a result of the partisan reconciliation bill--can you
explain CDC's decisionmaking infrastructure, process, and planning
mechanisms for deploying unprecedented sums of money in such a short
period of time? How does CDC plan for states and the public health
infrastructure to sustain these advancements when the supplemental and
mandatory funding runs out?
Answer. CDC is allocating funding to states based on the provisions
included in the statute. CDC uses funding mechanisms available to fit
the purpose outlined in the statute, and where needed, has developed
new ones.
The ability to respond to a public health emergency requires a
strong day-to-day public health system, supported by infrastructure
that is not highly segmented by disease, condition, or activity. In
addition to the COVID-19 pandemic, over the past 24 months, CDC has
also responded to diverse public health threats from E-cigarette or
Vaping Product Use-Associated Lung Injuries (EVALI), Ebola, complex
multi-state food-borne disease outbreaks, wildfires, and hurricanes.
Responding to the unique characteristics of each of these public health
emergencies has required deep scientific expertise to deploy a
specialized approach and called for a robust public health system with
world-class infrastructure nationwide to stop disease at its source.
Unfortunately, this recent history has revealed the effects of
inadequate public health infrastructure. Ongoing health disparities
made us as a nation more vulnerable to pandemics and large-scale public
health emergencies, as well as burdening large segments of our
population with chronic public health concerns. Additional investment
in both domestic and global public health infrastructure is needed as
proposed in the fiscal year 2022 Budget.
With investments requested in fiscal year 2022, CDC will begin to
address mission-critical gaps in public health infrastructure and
capacity nationwide. Transitioning from sporadic influxes of
supplemental funding tied to a specific emergency to flexible funding
that can prevent another crisis will strengthen the current public
health system. Flexible, sustainable investments in infrastructure and
capacity are critical for saving lives and averting economic losses
caused by public health emergencies and chronic public health problems.
In fiscal year 2022, CDC will prioritize funding to rebuild the most
critical public health infrastructure needed to safeguard the nation's
health and economic security.
Question. The Administration has placed an emphasis on addressing
health equity, especially as it relates to the pandemic response
efforts.
What trends are you seeing in rural communities right now with
regard to the pandemic?
Answer. Data continue to show the disproportionate impact of COVID-
19 on population groups, including people living in rural or frontier
areas. CDC's publication examining disparities in COVID-19 vaccination
coverage found COVID-19 vaccination was lower in rural counties (38.9
percent) than in urban counties (45.7 percent). These data are
available on the county tracker, which provides an integrated, county-
level view of key data for monitoring the COVID-19 pandemic in the
United States. It allows for the exploration of standardized data
across the country. The footnotes describe each data source and the
methods used for calculating the metrics. For the most complete and up-
to-date data for any particular county or state, visit the relevant
health department website.
Question. How does the CDC's health equity work account for the
needs of rural communities?
Answer. Rural areas face unique challenges both during the COVID-19
pandemic and when confronting ongoing public health challenges. The CDC
COVID-19 Response Health Equity Strategy, developed under the
leadership of the Chief Health Equity Officer Unit, affords a robust
platform from which CDC and its partners are pursuing deeper
engagements of diverse communities, stronger infrastructures to better
support data-driven action, and culturally responsive approaches
optimized for serving diverse, differentially impacted populations in
different areas, including rural and frontier populations. CDC has
provided historic funding to address health disparities, including
support for rural areas, as follows:
--$3.0 billion to strengthen vaccine confidence (awarded early April
2021): Funding will focus on reaching communities hit hardest
by the pandemic, including those in rural areas.
--$3.0 billion to ensure broad-based distribution, access and vaccine
coverage (awarded Jan. 2021): A minimum of 10 percent to
jurisdictions must be allocated for high- risk and underserved
populations, including rural communities.
--$2.25 billion to states and localities to address COVID-19 in
medically underserved communities including rural communities
and communities with large populations of racial and ethnic
minorities
Additionally, the Federal Retail Pharmacy Program continues to be
an important component in our commitment to address the
disproportionate and severe impact of COVID-19 on communities of color
and other underserved populations, including rural populations. From
February 10 to May 19, 2021, 46,811,020 vaccine doses had been
administered and reported by retail pharmacies across programs in the
U.S. A total of 21 retail pharmacy partners are participating in the
program, with more than 41,000 locations online and administering doses
nationwide.
CDC has numerous initiatives working to reduce disparities in rural
populations. A few examples include:
--Community Health Workers for Covid Response and Resilient
Communities (CCR) supports the training and deployment of
community health workers (CHWs) to response efforts and by
building and strengthening community resilience to fight COVID-
19 through addressing existing health disparities. Priority
populations are those with increased prevalence of COVID-19 and
are disproportionately impacted by long-standing health
disparities. Recipients to be announced at the end of August
2021.
--Racial and Ethnic Approaches to Community Health (REACH) program
works to reduce racial and ethnic health disparities, including
those found in rural communities. Interventions focus on proper
nutrition, physical activity, tobacco use and exposure, and
chronic disease prevention, risk reduction, and management.
--The Healthy Tribes Program funds tribal communities across the
country to strengthen connections to culture to promote healthy
lifestyles and reduce risk factors for chronic diseases. These
programs together support community-developed strategies that
work in rural settings to address the unique challenges that
contribute to health disparities for these communities.
--Scaling the National Diabetes Prevention Program in Underserved
Areas funds 10 national organizations to expand the reach of
the National Diabetes Prevention Program lifestyle change
program to underserved areas and populations, including hard-
to-reach rural regions of the US with fewer resources to
address health disparities. Priority populations include
Hispanic/Latino, African American, American Indian/Alaska
Native, and Asian American persons; Pacific Islanders; and
noninstitutionalized people with visual impairments or physical
disabilities.
Question. Dr. Walensky, as more Americans are vaccinated, there are
certainly going to be more ``breakthrough'' cases--individuals who test
positive for COVID-19 even after being fully vaccinated. This is to be
expected since no vaccine is 100 percent effective. What concerns me is
that while we're seeing breakthrough cases, for example the New York
Yankees reported a staggering number of breakthrough cases in the
spring, the CDC announced it will no longer track all breakthrough
cases.
Are we letting down our guard--should all COVID-19 cases continue
to be counted?
Answer. Despite the high level of vaccine efficacy, a small
percentage of fully vaccinated persons will develop symptomatic or
asymptomatic infections (i.e. breakthrough infections) with SARS-CoV-2,
the virus that causes COVID-19. The goal of national surveillance for
COVID-19 vaccine breakthrough infections is to identify unusual
patterns, such as trends in age or sex, the vaccines involved,
underlying health conditions, or which of the SARS-CoV-2 variants made
these people sick. To date, no unusual patterns in cases have been
detected in the data CDC has received.
Question. Can you explain why the change was made and exactly what
CDC is now tracking with regard to breakthrough cases?
Answer. State and local health departments report COVID-19 vaccine
breakthrough cases to CDC voluntarily. The number of COVID-19 vaccine
breakthrough infections reported to CDC likely are an undercount of all
SARS-CoV-2 infections among fully vaccinated persons. Reports may not
be complete and because not all infected persons get tested, not all
breakthrough cases will be identified. This is particularly true in
instances of asymptomatic or mild illness. The shift to focus on
hospitalized or fatal cases will help maximize the quality of the data
collected on cases of greatest clinical and public health importance,
while representative, scientifically valid data on vaccine
effectiveness comes from studies CDC is leading across the country.
Reporting vaccine breakthrough cases through national surveillance
is only one of the ways CDC measures COVID-19 vaccine effectiveness.
CDC continues to lead studies in multiple U.S. sites to evaluate
vaccine effectiveness and to collect information on COVID-19 vaccine
breakthrough infections from these sites regardless of clinical status.
For example, CDC is working with Emerging Infection Program (EIP) sites
in nine states to compare SARS-CoV-2 sequence data from vaccinated and
unvaccinated cases, regardless of clinical severity. CDC also is
working on more than 30 ongoing studies to assess vaccine
effectiveness, some of which include information on vaccine
breakthrough infections in patients with asymptomatic and milder
illness. Through these studies in various populations, locations, and
settings, CDC can obtain more representative, scientifically valid, and
complete information about these types of infections.
CDC is also using the Coronavirus Disease 2019 (COVID-19)-
Associated Hospitalization Surveillance Network (COVID-NET) to track
and analyze breakthrough infections. This population-based surveillance
system includes data on laboratory-confirmed COVID-19-associated
hospitalizations in 99 counties in 14 states, representing
approximately 10 percent of the U.S. population. COVID-NET cases are
hospitalizations occurring in residents of a designated COVID-NET
catchment area who are admitted within 14 days of a positive SARS-CoV-2
test. COVID-NET personnel collect COVID-19 vaccination status (doses,
dates administered and product) from state Immunization information
systems (IIS) for all sampled COVID-NET cases in 13 sites, which also
include information on clinical outcome. Some sites have expanded
collection of vaccination status to non-sampled cases, which were
included for analysis if all cases in a single month had vaccination
status available.
This strategic, deliberative approach will yield better information
on vaccine effectiveness and provide critical insight on cases of
greatest concern.
Question. Related, there is increasing concern about the public
health impact of long-term symptoms weeks or months after an individual
has had COVID-19.
What monitoring or tracking is the CDC undertaking with regard to
COVID ``long-haulers''?
Answer. CDC is spearheading rapid and multi-year studies to further
investigate post-COVID conditions (PCC), also known as ``long COVID''
or ``long-haul COVID.'' These studies will help us better understand
post-COVID conditions and how to treat patients with these longer-term
effects. For example, ongoing studies will follow patients for up to 3
years and provide information on the percent of persons who develop
post-COVID conditions, assess risk factors for development of post-
COVID conditions, and evaluate different virus strains and antibody
responses.
Question. How many long-haulers would you estimate are living with
post-COVID related symptoms?
Answer. At this time, we do not have a precise way to measure and
capture the prevalence of persons living with post-COVID-19 related
symptoms, but we know there are many people who are suffering from
this.
Currently, CDC and its Federal partners have proposed a new PCC
ICD-10 code and are looking at all considerations on how this may
impact the final version of this new code. The new ICD-code could
potentially be used for a range of conditions, including subsequent
chronic respiratory failure to help track and monitor people living
with PCC. CDC's National Center for Health Statistics (NCHS) presented
a proposal for public input to implement the code U09.9, post-COVID-19
condition, based on a proposed international classification of
diseases, tenth revision (ICD-10) code from the World Health
Organization (WHO) last year. This proposal is expected to move forward
after public input and may be implemented in October 2021 (as part of
the regular ICD-10 code process/timelines) to allow clinical data
systems and health insurers to adapt and fully implement it. We hope
this will provide us with a better estimate of those who may be living
with PCC.
Question. How does CDC plan to continue to monitor and track the
long-term impacts of COVID?
Answer. CDC is using multiple de-identified electronic health
record (EHR) databases to examine persistence of symptoms and incidence
of post-COVID conditions. CDC has also partnered with health systems to
perform in-depth medical record reviews, which can provide insight into
the patterns of health effects that patients are experiencing.
Question. Dr. Walensky, CDC has received a lot of criticism
throughout the pandemic. A lot of it is justified. And most of it
transcends political leadership at the agency. There are a lot of
lessons to be learned from what we did right and what we did wrong. As
I said in my opening statement, we did a lot right--so much so, in
fact, that we have three FDA authorized vaccines that are getting into
Americans' arms as we speak. But we also must recognize the missteps
when they happen as well. That is how we learn and how we become better
for the next public health emergency. Unfortunately, much of the
criticism about our pandemic response, that continues to this day,
revolves around the CDC. As Chair Murray and Senator Burr work on a
pandemic reform bill in the health authorizing Committee, I think it
would be a benefit to this Subcommittee to hear from you on these
issues as well. Can you please respond to the comments below:
Answer. First, CDC is risk adverse. I think that we have seen that
in several cases, from mask mandates for campers to discouraging travel
for the fully vaccinated.
Question. Second, CDC guidelines are impractical. The agency simply
doesn't issue guidelines that are clear and straightforward enough to
be useful. What I continually heard is that Federal guidance needs to
be practical for implementers on the ground or the American people to
follow it.
Answer. Since the early days of the pandemic, scientists at CDC
have been using evidence from systematic reviews and expert judgement
to develop guidance that informs various populations on how to slow the
spread of COVID-19 and protect their health and their communities. The
process and information communicated can be complex and evolves as our
understanding of the virus increases. CDC's group of multidisciplinary
stakeholders assesses the benefits and risks informed by data from the
field and issues evidence-based guidelines. State and local health
departments then decide how the research and guidance is implemented.
Question. Third, CDC has an entrenched bureaucracy that is
unwilling or unable to think big or implement on a large scale. The
perfect, and befuddling, example is why CDC didn't engage with private
sector partners like Abbott or Roche to commercialize their assay.
Testing was one of the early failures. Was this the reason why?
Further, at the outset, lab testing followed the flu model.
Asymptomatic spread requires significant testing, but this was low-
balled and kept in-house which could only produce about 100,000 tests
when what needed to happen was to engage the private sector labs to get
1-2 million higher volume throughput.
Answer. CDC aids and equips state and public health laboratories in
diagnostic testing for novel pathogens. When a new virus emerges or a
public health need for a new diagnostic tool arises, CDC may develop a
new diagnostic tool and, in partnership with state and local public
health partners and non-governmental organizations, strategize
distribution. This process is intended to fulfill needs within the
public health scope of outbreaks or new technologies. It is not
currently intended to replace or fulfill testing that may need to be
developed or distributed by commercial vendors to meet broader health
sector needs.
Furthermore, the EUA process for diagnostic (IVD) test development
and analysis/validation follows a predetermined framework at CDC, as
does deployment of the test after FDA authorization.
Question. Lastly, the Center structure at CDC is stove piped and
hampered the response. As a result, response efforts were locked into
the flu center, which treated COVID-19 like the flu--which spreads
symptomatically. Is this the reason we missed asymptotic spread?
Because we didn't have the right experts in charge or a CDC-wide body
responsible?
Answer. On January 7, 2020, the Director of the National Center for
Immunization and Respiratory Diseases (NCIRD) issued the directive
authorizing a Center Level Response, Novel Coronavirus (nCoV) 2019
Response, for the pneumonia outbreak in Wuhan, China in consultation
with the CDC Director. This Directive was effective January 6, 2020. As
the situation evolved, CDC escalated its response from the Center and
activated its Emergency Operations Center facilitating a CDC-wide
response on January 20, 2020.
When reports of asymptomatic spread first emerged, CDC's guidance
addressed the current circumstances. CDC proactively and aggressively
investigated evidence from the field, and updated its guidance
accordingly based on the best available data.
Question. Dr. Walensky, the Influenza Hospitalization Surveillance
Network (FluSurv-Net) is a population-based surveillance system that
collects laboratory confirmed influenza associated hospitalizations
from 14 states. The coverage area for FluSurv-Net is roughly 29 million
people, or 9 percent of the U.S. population. There is no site in
Missouri and the Midwest is not represented at all, except for Iowa.
How can the CDC accurately track an influenza outbreak without
real-time data from 36 states?
Answer. CDC's influenza surveillance systems are a collaborative
effort between CDC and its many partners in state, local, and
territorial health departments, public health and clinical
laboratories, vital statistics offices, healthcare providers, clinics,
and emergency departments. The system consists of complementary
components that capture virologic surveillance, outpatient illness
surveillance, hospitalization surveillance, and mortality surveillance.
This comprehensive surveillance infrastructure is used to identify when
and where influenza activity is occurring, determine which influenza
viruses are circulating, detect changes in influenza viruses, and
measure the impact influenza is having on outpatient illness,
hospitalizations, and deaths. Surveillance is performed continuously
throughout the year and data are presented in FluView, a weekly
influenza surveillance report, and FluView Interactive, an online
application which allows for more in-depth exploration of influenza
surveillance data, which are updated weekly.
Additionally, the HHS Protect Hospital Data reporting system
provides daily information on the number of patients hospitalized with
influenza-related and COVID-related illnesses from over 6,000 hospitals
in all 50 states and U.S. territories. This system provides situational
awareness of severe respiratory illness and local hospitalization
trends for influenza and COVID-19 on a daily basis that is beneficial
for monitoring severe illness during an outbreak.
Question. And how did the lack of real-time data stymy the response
to COVID-19?
Answer. COVID-19 highlighted the importance of real-time data
needed to get ahead and stay ahead of the disease. CDC must build on
initial investments and lessons learned from COVID-19 by investing in
the nation's public health infrastructure. The ability to respond to a
public health emergency requires a strong day-to-day public health
system, including efficient data sharing, and supported by
infrastructure that is not highly segmented by disease, condition, or
activity. With investment in fiscal year 2022, CDC will begin to
address mission-critical gaps in public health infrastructure and
capacity nationwide. Transitioning from sporadic influxes of
supplemental funding tied to a specific emergency to flexible funding
that can prevent another crisis will strengthen the current public
health system. Flexible, sustainable investments in infrastructure and
capacity are critical for saving lives and averting economic losses
caused by public health emergencies and chronic public health problems.
Question. Reports are already speculating that the next flu season
may be bad after a year of hardly any flu cases.
How concerned should we be that many Americans are left without an
immunity to flu--especially children--who may be more susceptible than
any other recent year?
Answer. A flu vaccine is the best way to protect children from flu.
CDC recommends that everyone 6 months and older should get a flu
vaccine every season. Annual vaccination is important to protect both
yourself and to provide protection for those who are more vulnerable to
serious flu illness, including children, older adults, and people with
certain chronic health conditions.
The flu can be dangerous for children. During the 2019--2020
season, nearly 200 flu deaths in children were reported to CDC in the
United States, which was the highest reported number of pediatric
influenza deaths on record. About 80 percent of those children were not
vaccinated. Last year, childhood influenza vaccination coverage is
estimated to have dropped 4.1 percentage points from 62 percent during
2019-2020 to 58 percent.
CDC is working diligently to support the vaccination of as many
Americans as possible during the upcoming influenza season. Vaccine
manufacturers have projected that they will supply 188 to 200 million
doses of influenza vaccine for the 2021-2022 season. CDC will continue
to emphasize the importance of influenza vaccination through targeted
communication outreach. CDC will build off its 2020-2021 communication
campaign, which was estimated to have been seen more than 5 billion
times. This year's media campaign will include population-wide outreach
and will have a special emphasis on targeting disproportionately
affected audiences, including people ages 40-64 with chronic medical
conditions, African American and Hispanic persons, essential workers,
pregnant women, and parents.
______
Questions Submitted by Senator Richard C. Shelby
Question. The Alabama Department of Public Health saw a delay in
the reporting of vaccine distributions upon the initial allocation of
vaccine allotments to states. Ultimately, there was not a delay in the
distribution of the vaccine, but in the reporting of administered
vaccines. In the last 15 months, Congress has appropriated $1.1 billion
to the CDC for the purpose of public health data modernization and
addressing public health data reporting issues that were experienced in
Alabama. In 2019, CDC stakeholders requested $1 billion over a ten-year
period to tackle public health data modernization, which CDC has
indicated is needed and Congress has far surpassed to this point. $500
million was appropriated through both the CARES Act and the American
Rescue Plan Act of 2021, and $50 million was appropriated for both
fiscal years 2020 and 2021 annual appropriations for the funding of
public health data modernization through the CDC.
Could you give a detailed description of how that $1.1 billion has
been used to date, who that funding has gone to (e.g., through
contracts, cooperative agreements, and grants), and for how much?
Please also provide a detailed plan for the remaining funds.
Answer:
ANNUAL APPROPRIATIONS
Table 1. Budget Plan for Annual Appropriations \1,2\
------------------------------------------------------------------------
Fiscal Year
Major Activity -------------------------------
2020 2021
------------------------------------------------------------------------
Partnering with State and Local Public $32.5M $32.5M
Health, Partners, and Health Care
Systems................................
Accelerating Public Health Data for $15.5M $15.5M
Action.................................
Sustaining Innovation................... $2 million $2 million
Total............................... $50 million $50 million
------------------------------------------------------------------------
\1\ Working Capital Fund and program support costs are spread across all
activities.
\2\ Amounts per activity are based on current information and may
require adjustment.
Data Modernization Base Funding
Congress recognized the need to modernize CDC's data systems and
provided funding in fiscal year 2020 dedicated specifically to data
modernization. DMI base funding is focused on strengthening and
sustaining the core foundational surveillance systems that state, local
and territorial jurisdictions use every day. These systems benefit all
of public health and serve as ``early warning signals'' for our biggest
threats--systems that handle emergency room visits, case reporting,
notifiable diseases, lab results, and death data. Investments to date
have laid the groundwork and spurred real progress, but much work
remains to be done.
In fiscal year 2020, CDC focused on solutions for the timely,
secure, and accurate flow of health data from electronic health
records, laboratories, and other primary data sources to state and
local jurisdictions and the multi-directional data flows between these
jurisdictions and CDC. The focus of these efforts has been on the
following:
--Expanded use of eCR and connectivity to Electronic Health Records
(EHR)
--Increasing the number of emergency departments and use of syndromic
and disease surveillance data through the NSSP
--Enhancing automated electronic laboratory reporting (ELR) and
implementation of Electronic Test Orders and Results (ETOR) at
clinical and public health laboratories
--Implementing improvements to birth and death reporting in NVSS
--Modernization of disease reporting through NNDSS and of states'
National Electronic Disease Surveillance System (NEDSS) Base
System (NBS)
CDC has continued to reimagine what its core surveillance systems
could deliver in fiscal year 2021. CDC works closely with public health
partners to reduce their reporting burden and make sure everyone has
the capacity to connect with each other. The pandemic drove huge leaps
in electronic case reporting (eCR), with thousands of healthcare
facilities now exchanging automated, real-time health information. All
50 states, D.C., and 11 large local jurisdictions are now capable of
receiving COVID-19 electronic case reports, up from only a handful of
jurisdictions in late 2019. The National Vital Statistics System (NVSS)
expanded its modernization community and began delivering provisional
COVID-19 death data and new data on excess deaths. Currently, 67
percent of deaths are reported electronically in less than 10 days, up
from 7 percent in 2010. CDC has dramatically improved the quality of
laboratory report data received by public health through nationwide use
of standardized messaging with Electronic Laboratory Reporting (ELR),
with 56 jurisdictions reporting lab data directly to CDC, up from zero
in 2019. Data from 70 percent of all U.S. emergency departments is
reported to CDC through the National Syndromic Surveillance Program
(NSSP), with 75 percent of emergency department data received in less
than 24 hours of a visit. As a result, more early warning signals from
systems that track emergency department visits and notifiable diseases
were and are being captured.
In fiscal year 2020, approximately $22.5 million was distributed
through a cooperative agreement to 58 awardees, including states,
cities, and territories, with an average award of $391,417. These funds
supported specific strategies, activities, and outcomes to improve
health information systems infrastructure, workforce development, and
public health laboratories. States have used these funds to conduct
needs assessments, strengthen technical and informatics skills,
streamline changes to surveillance systems, and identify a lead person
in each jurisdiction to support data modernization.
CDC is continuing to improve core public health data systems,
enhance data science and informatics workforce capabilities across the
public health systems, improve interoperability and innovation through
adoption of new standards and approaches for public health reporting
such as Fast Healthcare Interoperability Resources (FHIR) standards,
and support ongoing data modernization at CDC and with its partners.
Our focus in fiscal year 2021 has been on providing technical
assistance to state and local jurisdictions to leverage progress made
at the Federal, state, and local levels on electronic case reporting
(eCR) and Electronic Test Orders and Results (ETOR), as well as other
core systems and processes for data exchange. Technical assistance is
being provided by CDC and through a cooperative agreement with public
health partners like the Association of Public Health Laboratories
(APHL) and the Council of State and Territorial Epidemiologists (CSTE).
These partners are providing technical assistance to jurisdictions
focused on improving data sharing, accelerating use of shared decision
support services, data science upskilling of the public health
workforce, and developing and increasing use of standards to improve
quality and timeliness of reported data. Focus on continuing to improve
core public health data systems, enhance data science and informatics
workforce capabilities across the public health systems, improve
interoperability and innovation through adoption of new standards and
approaches for public health reporting (such as FHIR standards) and
support of ongoing data modernization at CDC and with its partners
CDC also provided funding through a cooperative agreement to three
tribal health entities to focus on three activity areas: augmenting
workforce development and capacity, identifying and deploying specific
enhancements in public health data and health information systems, and
employing shared services to improve data quality, exchange, and
management. CDC has provided funding to tribal entities in fiscal year
2021 to focus on the improving access to data, modernizing
infrastructure for data collection and analysis, and expanding
workforce data skills.
To keep CDC at the forefront of innovative, data-driven public
health solutions, we are strengthening skills for a state-of-the-art
data science workforce by supporting workforce development to assure
capable data scientists and informatics-skilled staff are available to
state, territorial, local, tribal, and Federal public health agencies.
In fiscal year 2020, CDC completed a pilot cohort of team training
through the Data Science Upskilling (DSU), which included 79 unique
learners on 18 teams. DSU is a new model of team training using
experiential learning tailored to agency priorities. Teams include both
CDC staff and fellows from the Public Health Informatics Fellowship
Program utilizing curated online courses and in-depth, boot-camp-style
training on topics like machine learning. Team projects align with
agency DMI priorities, CDC's winnable battles, or COVID-19 response.
CDC also funded the Council of State and Territorial Epidemiologists
(CSTE) to implement a similar program, Data Science Team Training
(DSTT).
DSTT was designed as a replica to CDC's Data Science Upskilling
program, with modifications to better meet state, tribal, local, and
territorial, needs. Training activities began in January 2021 with 20
teams and 86 learners. There is representation from a mix of state,
local, tribal, and territorial health departments.
cares act funds
Together with base funding, the Coronavirus Aid, Relief, and
Economic Security (CARES) Act extended and accelerated CDC's data
modernization goals for the nation. CARES funding focuses on
infrastructure, innovations, and connecting systems and data sources.
Rather than discrete, one-off projects or a narrow focus on individual
capacities, we have looked at the entire surveillance and data
ecosystem and identified the areas most in need of investment and
modernization. While COVID-19 is the priority, the end goal of DMI is
to create lasting, adaptable solutions that will make public health
more responsive and resilient in the future.
CARES funding is being invested across three major areas:
--Data Sharing across the Public Health Ecosystem
--Modernizing critical tracking capabilities and core surveillance
systems
--Extending data lakes and services that support electronic
laboratory reporting and immunization information
--Expanding the type, variety, and quality of data available to CDC
programs and STLT
--Automating the flow of data from electronic health records and
other sources
--CDC Systems and Service Enhancements for Ongoing Data Modernization
--Expanding enterprise cloud services to bring in and use large
datasets from partners in new ways
--Expanding CDC's enterprise data hub, orchestration, warehouse,
lake, analytics, and visualization capacity
--Building a state-of-the-art data science workforce
--Ensuring open and accessible data while protecting privacy and
security
--New Standards and Approaches for Public Health Reporting
--Implementing new standards and approaches, such as FHIR across the
public health ecosystem
--Assessing policy/legal barriers to sharing data, including STLT
data
Our work focused on data sharing across the public health ecosystem
includes modernizing critical tracking capabilities and surveillance
systems, such as the National Healthcare Safety Network (NHSN), Public
Health Environmental Tracking Network, the National Electronic Injury
Surveillance System-All Injuries Program (NEISS-AIP), and the National
Vital Statistics System (NVSS). We are also rapidly expanding
electronic case reporting (eCR) from healthcare to public health. We
have rapidly extended data lakes and services that support electronic
laboratory reporting and immunization information, including the
creation of a new immunization data lake that is now actively receiving
and making available 3.1M administration records per day. Funding has
also supported the creation of the Pan Respiratory Surveillance
Initiative, informing our knowledge of molecular surveillance, viral
evolution, and helping track trends in emerging variants.
Enhancements to CDC systems and service enhancements for ongoing
data modernization include deploying cloud-based technology to bring in
and use large data sets from partners in new ways, while also providing
highly scalable data analytic and visualization capabilities. This is
already strengthening our data sharing capabilities. For example, we
modernized data sharing with Homeland Security to ingest daily
international passenger arrival contact tracing information, parse it,
and provide it overnight to states through a secure, cloud-based file
transport system for STLTs to ingest into their individual tracking
systems. In the past year, the percentage of usable data has improved
to over 95 percent and time to transmit to STLTs has decreased from
days to overnight. Ongoing work to expand CDC's enterprise data hub,
orchestration, warehouse, lake, analytics, and visualization capacity
makes us better able to support modernization project needs across the
agency. We have streamlined identity proofing and access management,
use of enterprise code repositories, and enterprise security and code
complexity scanning. The CDC Data Hub actively continues to ensure that
analytics, including machine learning and artificial intelligence, are
enabled in cloud-based data pipelines. At the same time, we have
Initiated training opportunities to build a state-of-the-art data
science workforce, including CDC's Data Academy, which has delivered
more than 1000 hours of free training.
Our modernization efforts include developing new standards and
approaches for public health reporting. We are preparing CDC and our
STLT and healthcare partners to implement technologies and standards
that make systems interoperable and help these systems ``speak the same
language.'' Federal policies and advancements in technologies are
opening doors to make new connections for exchanging public health
data, and a major focus is on implementing Fast Healthcare
Interoperability Resources, or ``FHIR,'' across the public health
ecosystem. FHIR application programming interfaces (APIs) can help
public health to access detailed and timely data from EHRs while
lowering burden on and delivering greater value to data providers. We
are also working closely with jurisdictions and research partners to
innovate toward FHIR-based interoperability at every level. This will
give us more complete data and surveillance capabilities nationwide.
Our goal is to take what works and scale nationwide, through pragmatism
and collaboration to realize significant benefits to the way we use and
share data across all of public health.
Table 2. Budget Plan for CARES Act Appropriations \1,2\
------------------------------------------------------------------------
Funding Levels
Thematic Area for Fiscal Year
2020-2021
------------------------------------------------------------------------
Data Sharing Across the Public Health Ecosystem....... $140.55M
CDC Systems and Service Enhancements and Ongoing Data $120.62M
Modernization........................................
New Standards and Approaches for Public Health $13.83M
Reporting............................................
Additional fiscal year 2020 funding for Emergency $41.44M
Operations Center public health surveillance
activities...........................................
Future fiscal year 2022-2023 funding.................. $183.56M
TOTAL............................................. $500 million
------------------------------------------------------------------------
\1\ Working Capital Fund and program support costs are spread across all
activities.
\2\ Amounts per activity are based on current information and may
require adjustment.
american rescue plan funds
CDC appreciates further appropriations in data modernization
awarded through The American Rescue Plan Act. Where possible CDC is
evaluating recent investments made in national data infrastructure and
working with states to understand the gaps that still exist and
barriers to modernizing to further drive the best practices for
efficient and effective data modernization across the public health
ecosystem. Planning is currently underway to apply ARP data
modernization resources to drive a flexible, responsive, and modern,
response- ready data infrastructure.
______
Questions Submitted by Senator Jerry Moran
Question. In February, the CDC issued an order requiring face masks
on conveyances and at transportation hubs. Last week, you updated your
guidance for fully vaccinated individuals, saying they can stop wearing
masks indoors and outdoors. However, the CDC has not taken any steps to
update the February transportation order.
When can we expect such an update?
Answer. While those who are fully vaccinated may resume many
activities without wearing a mask, the travel environment presents a
unique set of circumstances based on the number and close interaction
of travelers (both vaccinated and unvaccinated). Traveling on public
transportation increases a person's risk of getting and spreading
COVID-19 by bringing people in close contact with others, often for
prolonged periods. Staying 6 feet away from others is often difficult
on public transportation conveyances. People may not be able to
distance themselves by the recommended minimum of 6 feet from other
people seated nearby or from those standing in or passing through the
aisles on airplanes or buses, for example.
Correct and consistent use of masks on public transportation
conveyances and at transportation hubs protects travelers and workers,
enables safe and responsible travel during the pandemic, and helps to
reduce the spread of coronavirus disease 2019 (COVID-19).
CDC will update the Order and other recommendations as more people
get vaccinated, as rates of COVID-19 change, and as additional
scientific evidence becomes available.
Question. Given the different risk levels of COVID transportation
across the transportation network, for instance traveling on public
transportation verses operating a freight locomotive, can we expect
different guidance?
Answer. CDC will continue to evaluate the requirements of its Order
and determine whether other changes are warranted by examining
characteristics like the transportation environment as well as indoor
and outdoor locations. CDC will update the Order and other
recommendations as more people get vaccinated, as rates of COVID-19
change, and as additional scientific evidence becomes available.
______
Questions Submitted by Senator Cindy Hyde-Smith
Question. There are two FDA-approved buprenorphine products for the
treatment of moderate to severe chronic pain. Both buprenorphine-based
products have been classified by the U.S. Drug Enforcement
Administration (DEA) as Schedule III meaning they have less abuse and
addiction potential compared to Schedule II drugs like oxycodone,
fentanyl, and oxymorphone. Furthermore, buprenorphine provides an
important safety advantage as it is the only opioid with a demonstrated
ceiling effect on respiratory depression, which is what typically leads
to death in an opioid overdose. In addition, there are several
buprenorphine-based products approved to treat opioid addiction. This
means that one of the same drug compounds that help millions of
Americans curb their addiction to illicit and prescription opioids can
also be used effectively to treat chronic pain with a lower chance of
addiction, abuse and overdose. However, it's my understanding that the
CDC's Guideline for Prescribing Opioids for Chronic Pain, which was
published in 2016, doesn't include any language about the benefits of
Schedule III buprenorphine products, even though they have less
potential for addiction and abuse, for the treatment of chronic pain.
Instead, the Guideline recommends starting opioid therapy with
immediate release Schedule II opioids, which have been shown to have
higher rates of addiction, abuse and overdose.
Do you know why the Guideline doesn't differentiate between
Schedule II and Schedule III opioids and recommend the use of Schedule
III opioids given their enhanced safety profile and lower risk of
abuse, addiction and overdose?
Answer. The evidence reviews informing the 2016 Guideline found
evidence of increased risks from extended-release/long acting (ER/LA)
full agonist opioids but did not identify other differences in safety
or effectiveness by type of opioid, including by schedule. Therefore,
there was no evidence on which to base recommendations to use different
types of opioids (except recommendations on ER/LA vs. short-acting
opioids).
Question. Can you provide an update on the process and timing of
the CDC's efforts to update the Guideline? Do you expect the updated
Guideline to consider DEA scheduling and recommend prescribers begin
opioid therapy with Schedule III drugs, when clinically appropriate,
before advancing to a Schedule II Drug?
Answer. CDC funded the Agency for Healthcare Research & Quality
(AHRQ) to conduct systematic reviews of the scientific evidence that
has been published since the Guideline's release in March 2016. These
reviews are the following:
--Noninvasive Nonpharmacological Treatment for Chronic Pain (An
Update)
--Nonopioid Pharmacologic Treatments for Chronic Pain
--Opioid Treatments for Chronic Pain
--Treatments for Acute Pain: A Systematic Review
--Acute Treatments for Episodic Migraine
Based on AHRQ's completed reviews, CDC has determined that an
update to the Guideline and an expansion of the Guideline to certain
acute conditions is warranted.
On December 4, 2019, the Board of Scientific Counselors of the
National Center for Injury Prevention and Control (BSC/NCIPC)
established the Opioid Workgroup (OWG). The OWG will report to the BSC/
NCIPC, a Federal advisory committee. The primary purpose of the OWG is
to review the updated draft Guideline for opioid prescribing (as
prepared by CDC) and to develop a report that will provide the
workgroup's findings and observations about the draft GL to the BSC/
NCIPC.
The OWG began reviewing a draft Guideline for opioid prescribing
(as prepared by CDC) in March 2021. The OWG met for a total of 11 times
since October 2020 and developed a report of findings and observations
about the draft Guideline update (prepared by CDC). The OWG presented
its findings at the July 2021 BSC/NCIPC meeting. The BSC/NCIPC will
then review the OWG's report and provide recommendations for CDC to
consider as part of the Guideline update process.
It is anticipated that a revised Guideline will be posted in the
Federal Register for a 60-day public comment in late 2021, which will
provide a critical opportunity for diverse input from the public.
Release of a final updated Guideline is anticipated to occur in
late 2022.
On opioid therapy--there are very limited clinical trial data
comparing safety and efficacy of partial agonist buprenorphine with
full agonist/schedule II opioids for chronic pain. In order to ensure
that the updated guideline would be informed by available clinical
evidence on types of opioids, CDC asked AHRQ to specifically address,
in its evidence review on opioids for chronic pain to inform CDC's
guideline update, the following questions on effectiveness and safety
of opioids by type of opioid:
``Key Question 1. Effectiveness and Comparative Effectiveness . . .
. b. How does effectiveness vary depending on . . . (4) the
type of opioids used (e.g., pure opioid agonists, partial
opioid agonists such as buprenorphine or drugs with mixed
opioid and nonopioid mechanisms of action such as tramadol or
tapentadol)?''
``Key Question 2. Harms and Adverse Events . . . . b. How do harms
vary depending on . . . (5) the mechanism of action of opioids
used (e.g., are there differences between pure opioid agonists
and partial opioid agonists such as buprenorphine or drugs with
opioid and nonopioid mechanisms of action such as tramadol and
tapentadol) . . . ?''
The AHRQ evidence review published in 2020 found very limited
evidence on comparative safety or effectiveness of opioids for chronic
pain by type of opioid. Please see the report for additional detail,
which can be found at https://effectivehealthcare.ahrq.gov/sites/
default/files/pdf/opioids-chronic-pain.pdf.
CDC is considering all findings from the AHRQ evidence reviews in
developing updated recommendations.
SUBCOMMITTEE RECESS
Senator Murray. The committee we will next meet in Dirksen
562, Wednesday, May 26 at 10 a.m., for a hearing on the Biden
Administration's Budget Request for the National Institutes of
Health.
Thank you very much.
[Whereupon, at 11:50 a.m., Wednesday, May 19, the
subcommittee was recessed, to reconvene at 10 a.m., Wednesday,
May 26.]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2022
----------
WEDNESDAY, MAY 26, 2021
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10:01 a.m., in room SD-562, Dirksen
Senate Office Building, Hon. Patty Murray (chairwoman)
presiding.
Present: Senators Murray, Reed, Shaheen, Schatz, Baldwin,
Murphy, Manchin, Blunt, Shelby, Graham, Moran, Kennedy, Hyde-
Smith, Braun, and Rubio.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
STATEMENT OF FRANCIS S. COLLINS, M.D., PH.D., DIRECTOR
ACCOMPANIED BY:
DIANA BIANCHI, M.D., DIRECTOR, EUNICE KENNEDY SHRIVER NATIONAL
INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE OF ALLERGY
AND INFECTIOUS DISEASES
GARY GIBBONS, M.D., DIRECTOR, NATIONAL HEART, LUNG, AND BLOOD
INSTITUTE
ELISEO PEREZ-STABLE, M.D., DIRECTOR, NATIONAL INSTITUTE ON
MINORITY HEALTH AND HEALTH DISPARITIES
NED SHARPLESS, M.D., DIRECTOR, NATIONAL CANCER INSTITUTE
BRUCE TROMBERG, PH.D., DIRECTOR, NATIONAL INSTITUTE OF
BIOMEDICAL IMAGING AND BIOENGINEERING
OPENING STATEMENT OF SENATOR PATTY MURRAY
Senator Murray. Good morning. The Senate Appropriations
Subcommittee on Labor, Health and Human Services, Education and
Related Agencies will please come to order.
Today, we are having a hearing on the Biden
Administration's fiscal year 2022 Budget Request for the
National Institutes of Health. Senator Blunt and I will each
have an opening statement, and then I will introduce our
witnesses. And after the witness testimony, Senators will each
have 5 minutes for a round of questions.
Before we begin, I do want to walk through the COVID-19
safety protocols that are in place today. And again, I really
want to thank all of our clerks and everyone who has really
worked hard to get this set up and help us all stay safe and
healthy. So, thank you to them.
For today, we are going to be conducting this hearing
following similar COVID protocols to what we have used in the
past. Committee members are seated at least 6 feet apart. Some
Senators are participating by videoconference. However, I do
expect that this will be our final hybrid hearing, and we will
be able to return to regular, in-person hearings at our next
hearing.
Consistent with CDC guidance, those who are fully
vaccinated do not need to wear a mask, though they may still
choose to do so. And while we are unable to have the hearing
fully open to the public or media for in-person attendance,
live video is available on our committee website. And if you
are in need of accommodations, including closed captioning, you
can reach out to the committee or the Office of Congressional
Accessibility Services.
As of today, almost half of U.S. adults are fully
vaccinated. And while we have a lot of work left yet to do to
reach communities who still cannot get vaccines and reassure
people who still have many questions about them, we can see the
light at the end of the tunnel. And, I really want to thank all
of our witnesses, especially Dr. Collins and Dr. Fauci, for
putting in long hours and putting science first.
Where we are at today is a testament to the tireless work
scientists at NIH have been doing to study this disease and how
we can best fight it, and oversee clinical trials for vaccines
and therapeutics and more, to ensure they are safe and
effective. And, of course, as our witnesses know, our
historically fast progress in fighting COVID-19 and developing
safe and effective vaccines was actually years in the making.
The pace of discovery we have seen this past year was made
possible by research into mRNA vaccines we funded in response
to Ebola and other viruses, and biomedical research enterprise
that has been built over decades to become one of the most
cutting edge in the world.
This should be an important reminder when it comes to
biomedical research. You can never fully predict how the
discoveries of today will prepare you for the challenges of
tomorrow. That is why you have to build the robust research
enterprise and recruit diverse, world class talent, and make
sure scientists can do their work free from political
interference.
And President Biden's budget, which proposes over $40
billion for NIH (National Institutes of Health), the largest
increase in the agency's history, will go a long ways towards
making sure we can continue to prioritize this. This budget
will reinforce our work to fight COVID-19, along with many
other diseases and disorders that threaten families in my home
State of Washington, or Missouri, or across the Country.
It includes funding to improve treatments for addiction and
substance use disorders, and funding to aid the fight against
cancer, Alzheimer's disease, and rare diseases families across
the Country are grappling with.
President Biden's budget request will also fund research to
help us study the health effects of climate change, which may
be increasing the number of infectious disease outbreaks;
identify solutions to gun violence, which continues to claim
tens of thousands of lives each year in this Country; and root
out the health inequities in our Country, which are undermining
the health of people of color, people with disabilities, rural
communities, those paid low incomes, and more.
The President has also proposed $6.5 billion for a new
initiative--the Advanced Research Projects Agency for Health.
Like the defense initiative it is inspired by, ARPA-H is
envisioned as breaking the mold for how cutting-edge research
is conducted, speeding up the development of medical treatments
by funding innovative projects. I am interested to hear more
about how it can add to NIH's work and operate as something
truly distinct from its other traditional, biomedical research
programs.
Of course, at the end of the day, innovation is not just
driven by new programs and new investments. It is driven by
people, which is why with as much as we invest in NIH each
year, and as important as its work to its families, our
families, we cannot afford to have this agency's potential
limited or its success threatened by bias, discrimination,
harassment, or assault in the workplace.
Unfortunately, we know that in the biomedical research
community, the prevalence of researchers of color is too low,
and the prevalence of sexual harassment is too high. These are
real problems with real consequences for biomedical research
and the people who do the lifesaving work we are all
benefitting from today.
I commend NIH for the efforts it has taken on both of these
fronts so far. NIH has done work to examine barriers to
diversity among its researcher ranks and how its own practices
have reinforced structural biases that allow discrimination to
persist. But, more work remains to tear down barriers and
create lasting change.
And when it comes to sexual assault, Director Collins, I am
glad you have taken some forceful action to address the problem
among the NIH workforce, but NIH must do more to use its
enormous influence with the research community to enforce
change in the Nation's universities and research institutions.
I expect NIH to continue building on its efforts so far to
remove racism, discrimination, and harassment from research,
and I will continue to follow up on that progress.
Finally, as proud as we all are of our Nation's biomedical
research institutions, we do not invest billions of dollars in
biomedical research out of pride, nor do we invest in them to
help pharmaceutical companies make astronomical profits. We do
it to bring new treatments, cures, and hope to people across
the Country and across the world. It is important that we never
lose sight of this because even the most brilliant miracle cure
can only save people if they can actually get it.
Just as I hope to work with my colleagues on both sides of
the aisle to make lifesaving investments in biomedical research
like those proposed in the President's budget, I also hope we
can work together to bring down the cost of healthcare,
especially for prescription drugs; keep working towards
universal health coverage; and bring the cures we are investing
in to the families who need them.
With that, I will turn it over to Senator Blunt for his
remarks.
STATEMENT OF SENATOR ROY BLUNT
Senator Blunt. Well, thank you, Chair Murray. I appreciate
having this hearing today and appreciate being able, again, to
start this process with you as we did last week on our first
hearing.
I am certainly glad that Dr. Collins and the Institute
directors are here with us today. I think two of the directors
are testifying before the committee for the first time, and,
so, welcome to the two of you. And this is a helpful
relationship for us, and hopefully for you.
Certainly, the challenges we have faced over the past year
have been unanticipated and significant. I think the global
pandemic reinforced the importance of the National Institutes
of Health. In less than a year, NIH was able to take this novel
coronavirus and help develop two FDA (Food and Drug
Administration)-authorized vaccines, two FDA-authorized
therapeutics, and 16 rapid diagnostic tests, including the
first FDA-authorized point-of-care diagnostic test for COVID-19
to combat its spread and its effects.
A year ago, when we would have had a similar discussion,
one of the big topics would be, why can't we get enough tests?
NIH stepped up and really played a big role in seeing that we
had enough tests. We have not heard that discussion for a long
time. And that does not mean that millions of tests are not
being taken every day. It just means we figured out at this
committee and NIH to be part of meeting that need.
It was revolutionary to watch NIH work, but it did not just
happen. In a time of crisis, during shutdowns, during social
distancing, dealing with a disease that has never been seen
before, the system and its nationwide grantees were able to use
their expertise and infrastructure to, again, develop tests,
treatments, and vaccines. Our research infrastructure was
tested like never before and, in my opinion, it succeeded in
remarkable ways.
I believe there are really three reasons for that. First,
in the past 6 years, this committee and the Congress, in a
bicameral, bipartisan way have prioritized and invested in NIH.
Within that 6-year timeframe, funding for medical research
increased by almost $13 billion, or nearly 43 percent over that
6 years after a decade at virtually level funding. This
investment encouraged young scientists, young researchers, and
mid-career researchers that were leaving the field before that
to stay in the field. And, with your insistence, Dr. Collins,
some of that money every time was set aside to be sure that it
was going to first-time grantees.
We were able to shore up the research infrastructure across
the Country and provide research into mRNA, an idea that had
never produced a vaccine before and, of course, became the
foundation for the two principal vaccines that were developed
very much with the involvement of NIH.
Our ability to pivot so quickly and so successfully to
fighting COVID-19 could not have been accomplished had we
stayed at the funding levels we were at 7 years ago. The buying
power was not where it needed to be. Young researchers were
leaving the field. Tough budgetary decisions meant that people
were not only getting their applications rejected at
significant levels; they just, frankly, stopped making a lot of
applications. That is not your problem, by the way, today.
Second, at the height of the pandemic, Congress gave the
Department of Health and Human Services significant funding and
flexibility to create Operation Warp Speed. It was successful
in developing two FDA-authorized COVID-19 vaccines and
commercializing another with the help of NIH because we united
in our effort to make that happen.
One of the things we did was to really invest in vaccines
that we did not think were certain to work, but thought were
likely to work, and that meant that vaccines were available
when they got FDA authorization rather than months after they
got FDA approval. Because of that, fully half of all adults
have been vaccinated now in the United States as we work toward
a bigger number than that.
We pushed private industry and worked with private industry
in ways we had not before. I have said at the time, one way to
win the horse race is to bet on all the horses. And I think to
a great extent we did in the vaccine effort, bet on all the
horses we thought had a chance to finish the race, and it made
a difference.
Finally, one of the most important lessons learned from the
pandemic is the value of having the Federal Government, on
occasion, as a more active partner in research and development
instead of just a sponsor. The ambitious speed and goals that
pushed private companies to research, develop, and manufacture
a COVID-19 vaccine, along with what we did in testing, really
created the kind of breakthroughs we needed.
RADx and Warp Speed, I think put us in a different place
than we would have been 2 years ago in thinking about how we
can look at some of our research efforts in another way. That
is why I want to work with the Administration to support the
ARPA-H initiative. This will be a new institute, or is proposed
to be a new institute, and I think that is what should be the
case. They will have the flexibility and tools necessary to
both nimbly and innovatively respond to both the next pandemic
and also some of the big health issues we face today.
This is a critical moment in a rapidly changing healthcare
world. Finding those things that the kind of Warp Speed, Shark
Tank, RADx relationship could enhance in cancer, in
Alzheimer's, in every disease where there is an opportunity;
where we see that moment and know that this is something that
does not necessarily call for a 5-year research grant, but some
sort of partnership different than that that moves toward a
real conclusion sooner than we might otherwise be able to do
that.
ARPA-H should not do what the other institutes do, but it
should do what the other institutes cannot do in a crosscutting
way that goes throughout the institutes, looking for
opportunities, frankly, in the other institutes where there is
a breakthrough moment that we could look at differently. I
think we can help fill gaps here that otherwise would not be
filled and look forward to that discussion.
Now, also, as someone working with Senator Murray for the
last 6 years to increase the funding and the focus in what NIH
has been doing, we clearly want to be sure that this somehow
does not take away from the solid research that proves so
effective in getting us ready for what we just saw.
So, Dr. Collins, I look forward to working with you and
Chair Murray and the Administration in making ARPA-H a reality.
I think the moment is ready for that. I think because of what
has happened in the last 2 years, NIH is ready for that, and
look forward to the discussion today.
[The statement follows:]
Prepared Statement of Senator Roy Blunt
Thank you, Chair Murray. I appreciate Dr. Collins and the other
Institute Directors for being here today.
The challenges we have faced over the past year in a global
pandemic reinforced the importance of the National Institutes of
Health.
In less than a year, NIH was able to take this novel coronavirus
and develop two FDA-authorized vaccines, two FDA-authorized
therapeutics, and 16 rapid diagnostic tests, including the first FDA-
authorized point-of-care diagnostic test for COVID-19, to combat its
spread and effects.
This was revolutionary, and it didn't happen without decades of
preparation.
In a time of crisis, during shutdowns and social distancing, for a
disease never seen before, the NIH and their nationwide system of
grantees were able to use their expertise and infrastructure to develop
tests, treatments, and vaccines for COVID-19. Our research
infrastructure was tested like never before, and it succeeded. And I
believe there were three key reasons behind this success.
First, for the past six years, this Committee and Congress have
prioritized and invested in NIH. Within this timeframe, funding for
medical research increased by $12.85 billion, or nearly 43 percent,
after having spent the previous decade at virtually level funding.
This investment encouraged young and mid-career scientists in the
field, who often have the most novel and innovative research ideas,
shored-up the research infrastructure across the country, and provided
research into mRNA, which is the foundation for two of the COVID-19
vaccines.
Our ability to pivot so quickly and so successfully to fighting
COVID-19 could not have been accomplished had this Committee let NIH
funding stagnate for another decade, dragging down its buying power,
and letting young researchers leave the field. Making the tough
budgetary decisions necessary to prioritize the NIH paid off.
Second, at the height of the pandemic, Congress gave the Department
of Health and Human Services significant funding and flexibility to
create Operation Warp Speed. It was successful in developing two FDA-
authorized COVID-19 vaccines and commercializing another, with the help
of NIH, because it united the federal government, private companies,
and researchers around a common goal.
The reason that we have been able to fully vaccinate half of all US
adults is because there was a deliberate strategy in the last
Administration to focus and provide funding for any COVID-19 vaccine or
therapeutic that had the likelihood to work. We took financial risks to
manufacture vaccines as the development process was still underway.
We pushed private industry to innovate their own approaches. And we
forever changed the drug approval process. As I have said before, the
way to win a horse race is to bet on all the horses. That is what this
Committee and the previous Administration did.
Finally, one of the most important lessons learned from the
pandemic is the value of having the Federal Government become a more
active partner in research and development, instead of just a sponsor.
The ambitious speed and goals that pushed private companies to
research, develop, and manufacture a COVID-19 vaccine through Operation
Warp Speed demonstrated that active collaboration in public-private
partnerships, in conjunction with significant funding, are game
changers in creating scientific breakthroughs.
Now we must learn from these lessons. There is an opportunity to
build upon Operation Warp Speed and NIH's RADx diagnostic testing
program to leverage public-private partnerships to dramatically
accelerate the development and approval of new treatments and
technologies. What two years ago would have been termed risky and
financially unpalatable now is possible.
And that is why I want to work with this Administration to support
the ARPA-H initiative. This will be a new Institute that will have
flexibility and tools necessary to nimbly and innovatively respond to
both the next pandemic and also to some of the biggest health issues
Americans face today, like cancer and Alzheimer's disease.
ARPA-H should do what other NIH Institutes cannot. It needs to be
cross-cutting throughout all the NIH Institutes and collaborative both
internally with NIH and HHS and externally with partners. It needs to
be innovative. And it should help fill the gaps we clearly saw during
the pandemic between basic science and commercialization of COVID-19
vaccines and therapeutics.
Simply put, there are aspects of NIH research that could move much
faster outside the traditional NIH grant cycle. The NIH peer review
process is the gold standard, but we also need to recognize that it
doesn't work for all research at all times.
I look forward to working with you, Dr. Collins, and you, Chair
Murray, on making ARPA-H a reality.
It will take collaboration between the Administration, NIH, and
Congress. But as we work toward a new Institute to accelerate the
application and implementation of health discoveries, we must make sure
that basic science is not abandoned. ARPA-H should not be the shiny new
toy we all focus on, especially not to the detriment of the NIH
research community as a whole.
If there is one lesson we must take from this pandemic, it is that
our nation's success depends on the medical research infrastructure
across this country supported by the NIH. Now is not the time to
abandon it. Now is the time to make it even stronger.
Thank you.
Senator Murray. Thank you very much, Senator Blunt.
I will now introduce our witnesses.
Dr. Francis Collins is the director for the National
Institutes of Health.
Dr. Diana Bianchi is the director of the Eunice Kennedy
Shriver National Institute of Child Health and Human
Development.
Dr. Anthony Fauci is the director of the National Institute
of Allergy and Infectious Diseases.
Joining us virtually is Dr. Gary Gibbons. He is the
director of the National Heart, Lung and Blood Institute.
Dr. Eliseo Perez-Stable is the director of the National
Institute on Minority Health and Health Disparities.
Dr. Ned Sharpless is the director of the National Cancer
Institute.
And, finally, Dr. Bruce Tromberg is the director of the
National Institute of Biomedical Imaging and Bioengineering.
So, Dr. Collins, we will turn to you for your opening
remarks.
SUMMARY STATEMENT OF DR. FRANCIS S. COLLINS
Dr. Collins. Thank you, Chair Murray and Ranking Member
Blunt and distinguished members of the subcommittee. I am
honored to be here today with my colleagues representing the
National Institutes of Health, the NIH.
I could spend hours describing the exciting work the
President's budget is proposing for NIH, including major
investments to address impacts of the COVID-19 pandemic, reduce
health disparities in maternal mortality, improve mental
health, broaden approaches to pain and opioid addiction, and
establish a bold, new agency within NIH called ARPA-H.
But, in our brief time together, it is also important to
emphasize how steady funding increases that you have provided
to NIH, starting well before the pandemic, made it possible for
NIH to meet the challenges of the pandemic and to prepare for
what comes next.
Often at these hearings, I share a story of a patient whose
life has been saved by NIH research, but in this uniquely
challenging year, it is hard to single out any one person. In
fact, all of the more than 160 million Americans who have
received COVID-19 vaccines as of today are success stories made
possible by the sustained investment that this committee made
years ago to basic biomedical research.
The road to these mRNA vaccines actually started back in
the 1960s when the function of messenger RNA was first
understood. These messengers carry instructions from the cell's
DNA manual to produce the proteins that do the work. Now, for
vaccines, we knew that certain proteins, like the spike
proteins on the coronavirus, could spur an immune response.
But, might it be safer and just as effective to use the RNA,
the codes for those spike proteins, to instruct the patient's
body to produce them? And it took a lot of obstacles to
surmount to get there over more than 20 years, but we are blown
away by how well it works.
In parallel, other NIH-supported scientists, including some
at our own Vaccine Research Center, learned that locking those
spike proteins into the right configuration could make an even
better vaccine. So, when COVID hit, we knew exactly what to do,
but we needed the help of the American people enrolling in
clinical trials to finish the job. To facilitate that, NIH
opened a dialogue with communities disproportionately affected
by COVID to ensure that they had access to the vaccine trials.
The Community Engagement Alliance, or CEAL, c-e-a-l,
Initiative built on some existing, long-term partnerships with
trusted leaders in underserved communities to engage directly
on trial enrollment, and later with hesitant individuals on
issues related to vaccine safety and efficacy.
We were able to use the enrollment techniques we learned in
the large, longitudinal studies, such as All of Us, that you
have championed. The result is that all Americans can look at
the major vaccine trials and see that people like them were
included.
While the vaccines were in early trials, the world was
clambering for rapid diagnostics to understand and manage our
risks. Members of this committee, most notably Senator Blunt,
asked what NIH could do to ramp up innovation. And thanks to
your support, and using a novel Shark Tank approach, NIH took
on a new role as a venture capitalist through the Rapid
Acceleration of Diagnostics, or RADx program.
Today, there are 33 novel testing platforms helping perform
just today, millions of tests daily, due to RADx. This program
demonstrated the remarkable innovations that are possible when
NIH brings together experts in engineering, business, and
manufacturing to fund big ideas.
Now, the President's budget proposes a major investment to
build on this momentum the Advanced Research Projects Agency
for Health, or ARPA-H. This new agency within NIH will catalyze
novel strategies to speed transformational and innovative
ideas, ideas such as simple blood tests to detect free-floating
DNA or protein markers that signal a cancer is growing
somewhere in the body; a micro needle patch that delivers a
vaccine to hard-to-reach communities in the mail; using an
innovation funnel to recruit, test, and scale up new
technologies for ambulatory blood pressure measurement with the
potential to transform the management of hypertension.
These are just a few of the bold ideas that ARPA-H could
tackle, but they are not science fiction. With standard
approaches, well, they might happen in a decade or two. With
ARPA-H, we believe it could take half that time.
The President believes that with your help, we can learn
from the lessons of pandemic and transfer this scientific
momentum into big improvements in the health of all Americans.
I do, too.
My colleagues and I would be pleased to answer your
questions.
[The statement follows:]
Prepared Statement of Francis S. Collins, M.D., Ph.D., Diana W.
Bianchi, M.D., Anthony S. Fauci, M.D., Gary H. Gibbons, M.D., Eliseo J.
Perez-Stable, M.D., Norman E. Sharpless, M.D., and Bruce J. Tromberg,
Ph.D.
Good morning, Chairwoman Murray, Ranking Member Blunt, and
distinguished Members of the Subcommittee. I am Francis S. Collins,
M.D., Ph.D., and I have served as the Director of the National
Institutes of Health (NIH) since 2009. It is an honor to appear before
you today.
First, I want to thank this Subcommittee for your commitment to
NIH, which allowed the biomedical research enterprise to respond
quickly to the greatest public health crisis in our generation over the
past year. We mounted vigorous research efforts to understand the viral
biology and pathogenesis of the coronavirus disease 2019 (COVID-19),
develop vaccines in record time, support and commercialize diagnostics
at the point of care, and test therapeutics for both outpatient and
inpatient settings. This work is far from finished.
The President's Discretionary Request proposes budget authority of
$51 billion for NIH in fiscal year (FY) 2022. The Biden Administration
places great emphasis on research and development in general. At NIH in
particular, the Request proposes to build on the successes of pandemic
era research and to put the research enterprise to work on some of our
Nation's most persistent and perplexing health challenges, including
cancer, Alzheimer's disease, opioid use disorder, health disparities,
maternal mortality, HIV/AIDS, gun violence, climate change, and other
areas with major implications for our Nation's health.
First and foremost, the President's Request proposes $6.5 billion
to establish the Advanced Research Projects Agency for Health--ARPA-H
to drive transformational innovation in health research and speed
application and implementation of health breakthroughs. ARPA-H will
tackle bold challenges requiring large scale, cross-sector
coordination, employing a non-traditional and nimble approach to high
risk research, modeled after DARPA in the Department of Defense. To
achieve this, ARPA-H will invest in emergent opportunities by
conducting advanced systematic horizon scans of academic and industry
efforts, leveraging novel public-private partnerships, recruiting
visionary program managers, and using directive approaches that provide
quick funding decisions to support projects that are results-driven and
time-limited. Potential areas of transformative research driven by
ARPA-H include: the use of the mRNA vaccines to teach the immune system
to recognize any of the 50 common genetic mutations that drive cancer;
development of a universal vaccine that protects against the 10 most
common infectious diseases in a single shot; development of wearable
sensors to measure blood pressure accurately 24/7; and leveraging of
artificial intelligence technology to advance care for individual
patients and improve detection of early predictors of disease.
ARPA-H represents the kind of transformative idea for biomedical
research that only comes along once in a long while. Our confidence
that NIH is ready has been greatly advanced by our experience in
addressing the COVID-19 pandemic--developing vaccines in record time,
establishing an unprecedented public-private partnership on
therapeutics that has made it possible to test more than a dozen
possible therapeutics in rigorous trials, and building a venture
capital model for assessing SARS-CoV-2 diagnostic technologies that has
yielded millions of daily tests in just months.
But while we begin to imagine a life after COVID-19, we must
acknowledge that there are COVID-related impacts that we have yet to
understand and address, including the full impact of the pandemic on
children. Children were largely spared from COVID-19 but for some
children, exposure to the COVID-19 virus led to Multisystem
Inflammatory Syndrome in Children (MIS-C), a severe and sometimes fatal
inflammation of organs and tissues. The Eunice Kennedy Shriver National
Institute of Child Health and Human Development (NICHD) is leading a
multi-institute initiative known as the Collaboration to Assess Risk
and Identify loNG-term outcomes for Children with COVID (CARING for
Children with COVID), which will assess both short-term and long-term
effects of MIS-C and other severe illness related to COVID-19 in
children, including cardiovascular and neurodevelopmental
complications.
For many Americans, this pandemic and its related socioeconomic
effects have had an overwhelming impact on their mental health. Prior
research on disasters and epidemics has shown that in the immediate
wake of a traumatic experience, large numbers of affected people report
distress, including new or worsening symptoms of depression, anxiety,
and insomnia. To aid in mental health recovery from the COVID-19
pandemic, NIH will continue to focus on research in this area. This
will be done, in part, by utilizing participants in existing cohort
studies, who will be surveyed on the effect of the pandemic and various
mitigation measures on their physical and mental health.
The COVID-19 pandemic has brought into sharp focus the dramatic
health disparities that exist across the American population. In
addition, the Nation has been shaken by the killing of George Floyd and
other attacks on people of color, forcing a recognition that our
country is still suffering the consequences of centuries of racism. NIH
will continue to address these disparities, specifically through
research managed by the National Institute on Minority Health and
Health Disparities (NIMHD), the National Heart, Lung, and Blood
Institute (NHLBI), the National Institute of Nursing Research (NINR)
and the Fogarty International Center (Fogarty).
NIMHD looks to better understand the human biological and
behavioral mechanisms and pathways that affect disparity populations,
better understand the long-term effects of disasters on health care
systems caring for populations with health disparities and research
focusing on the societal-level mechanisms and pathways that influence
disease risk, resilience, morbidity and mortality. NINR and Fogarty
both look to better understand and reduce rural health disparities in
low-income counties in the southern United States, support nursing
science focused on racial, ethnic, and socioeconomic health
disparities, with the goal of closing the gap in health inequities and
increase health disparity research in low and middle income countries.
In addition to the core health disparities research, the
President's Request puts an additional specific focus on maternal
morbidity and mortality (MMM), which disproportionately affect specific
racial and ethnic minority populations. Black and American Indian/
Alaska Native individuals are two to four times more likely to die from
pregnancy-related or pregnancy-associated causes compared to white
individuals. Furthermore, Black, Hispanic and Latina Americans, Asian,
Pacific Islander, and American Indian/Alaska Native individuals all
have higher incidence of severe maternal morbidity (SMM) compared to
white individuals. The Implementing a Maternal Health and Pregnancy
Outcomes Vision for Everyone (IMPROVE) initiative supports research on
how to mitigate preventable MMM, decrease SMM, and promote health
equity in maternal health in the United States.
As the climate continues to change, the risks to human health will
grow, exacerbating existing health threats and creating new public
health challenges. Major scientific assessments document a wide range
of human health outcomes associated with climate change. While all
Americans will be affected by climate change, underserved populations
are disproportionately vulnerable. These populations of concern include
children, the elderly, outdoor workers, and those living in
disadvantaged communities. NIH is poised to lead new research efforts
to investigate the impact of climate on human health, with the goal to
understand all aspects of health-related climate vulnerability.
Therefore, the President's Request includes a $100 million increase for
research on the human health impacts of climate change.
The FY 2022 President's Discretionary Request makes a major
additional investment to address the opioid crisis. The crisis of
opioid misuse, addiction, and overdose in the United States is a
rapidly evolving and urgent public health emergency that has been
exacerbated by the coronavirus pandemic. Since the declaration of a
public health emergency for COVID, illicit fentanyl use and heroin use
have increased, and overdoses in May 2020 were 42 percent higher than
in May 2019.
The use of opioids together with stimulants, such as
methamphetamine, is increasing; and deaths attributed to using these
combinations are likewise increasing. Taking note of these trends, FY
2021 appropriation language expanded allowable use of Helping to End
Addiction Long-term (HEAL) funds to include research related to
stimulant misuse and addiction. Identifying how opioids and stimulants
interact in combination to produce increased toxicity will enhance our
ability to develop medications to prevent and treat comorbid opioid and
stimulant use disorders and overdoses associated with this combination
of drugs.
Finally, I'd like to take a moment to thank this Subcommittee for
its recognition over the last two years that America's continuing
leadership in biomedical research requires infrastructure and
facilities that are conducive to cutting-edge research. With your
support, we will break ground in the near future on a new Surgical,
Radiological, and Laboratory Medicine division of our Clinical Center,
which will replace severely outdated and deteriorating operating suites
and lab space with state-of-the-art facilities. NIH continuously works
to ensure that the buildings and infrastructure on its campuses are
safe and reliable and that these real property assets evolve in support
of science--but NIH's backlog of maintenance and repair is now nearly
$2.5 billion. The President's FY 2022 Discretionary Request includes
$250 million to make progress on reducing this backlog and requests
flexibility for Institutes and Centers to fund construction, repair,
and improvement projects.
COVID-19 compelled us to perform a stress test on biomedical
research enterprise. The enterprise performed nobly. We found what
worked, and also identified barriers we hadn't fully appreciated
before, and invented new ways around them. The President's FY 2022
Discretionary Request is a roadmap for how to build on the successes of
research, address our gaps, and apply our insights to the most
important problems we face as a nation. With your support, the future
is filled with opportunity. My colleagues and I look forward to
answering your questions.
Senator Murray. Thank you very much, Director Collins. I
have to say, I have always loved your success stories. They are
usually really beautiful. But, I will say, I think many of us
in this room are grateful to be your success story this time.
So, thank you.
We will now begin our 5-minute rounds of questions, and Dr.
Collins, I will start with you.
As you just talked about, the President's budget includes
$6.5 billion to create the ARPA-H within NIH that is modeled
after DARPA. DARPA is a small, $3.5 billion agency that is
composed mostly of program managers and empowered to push the
limits of their disciplines and shape some milestone-driven
breakthrough technologies in short 3- to 5-year stints.
Given that the nature of NIH's work is different, relying
on a peer review system or multi-year grants that is
traditionally risk-adverse, where progress is often measured in
decades, how do you envision ARPA-H fitting into the NIH
ecosystem?
ARPA-H STRUCTURE
Dr. Collins. Senator, it is a great question. I think you
are right that much of what NIH does requires this kind of
careful, deliberative, investigator-initiated, hypothesis-
driven research, and that is going to be the mainstay of what
we do going forward. That has been the success story of NIH for
many decades.
But, there are opportunities, as we have seen happen during
COVID, such as the need to develop diagnostics in a hurry, to
develop vaccines in a hurry, that are not really amenable to
that approach, where you need to have program managers that are
empowered to move things swiftly and have the flexibility and
the resources to do so. And that is the DARPA model. We have
studied that closely, and we do think that there are projects
in biomedicine now that would be greatly advantaged by that.
That is not the typical peer review process that may take a
year from the idea to the first award. With RADx, we made those
first awards 5 days after the Congress gave us the budget for
it, and that played out really well.
So, we want to incorporate that mindset, and we want to
bring on perhaps a hundred of these program managers, give them
the opportunity to build the kind of collaborative ventures
that include such organizations as small businesses that might
otherwise not be likely to write an NIH grant.
Ride herd over these things carefully so that if they are
not doing well, they get basically stopped immediately. We
expect there will be failures--this is high risk--but identify
the areas of greatest opportunity. And every Institute at NIH
is now coming forward saying, I have at least five ideas of
what I would like to do with ARPA-H that I cannot do right now.
So, this should not be seen as competing with the
Institutes. It is going to be a synergistic relationship that
will allow us to do things otherwise that would take a very
long time.
Senator Murray. Okay. Well, you have said that it should be
within the office of the director. In that structure, how would
decisions be made about what projects to fund?
Dr. Collins. So, we will need to hire a director for ARPA-
H, who will need to be a visionary person, and the idea is to
bring on somebody who is not probably going to be doing this as
their long-term career, but maybe for one term, 5 years, with
one possible renewal.
That person will be very much engaged then in bringing
onboard these very creative program managers who have to make a
pitch about what kind of projects they think are worth
investing in and convince the director that that is the case.
And, then, they are given the flexibilities to go out and find
the right partners and see what can happen. But, that is all
going to be done in a way that is quite nimble. It is not going
to involve our traditional peer review process.
Senator Murray. Okay.
STRUCTURAL RACISM AND HEALTH EQUITY
Dr. Perez-Stable, your career has really focused on
improving the health of communities of color and underserved
populations. And NIH recently released a $30 million funding
opportunity to study the impact of structural racism and
discrimination in order to promote health equity and eliminate
health disparities. Can you talk to us a little bit about what
more can NIH, and particularly NIMHD (National Institute on
Minority Health and Health Disparities), be doing to address
those issues, and what would be the benefit of making
additional investments?
Dr. Perez-Stable. Thank you, Senator Murray, for that
question. So, first of all, we had to recognize that structural
racism could be operationalized as a research construct and not
just an organizational construct, and we went through a
workshop and scientific reflection on this. I think the moment
earlier this year for all of the NIH Institutes and Centers
agreed that this was an area that we needed to move on and
advance more quickly in the research side. And, so, we had a
commitment from all the institutes that do this, although NIMHD
was leading it from the beginning.
We believe that two areas are susceptible for improvement.
One would be the healthcare setting, where I think through
interventions at the structural, as well as the clinician and
the patient level will help. And, also, in promoting healthy
communities so that we can have easier access to green space,
to healthy food, accessible healthcare in community health
centers.
These are two areas that we believe are susceptible for
improvement, although we will depend on our scientific
community to promote and submit ideas that will be reviewed and
hopefully funded within fiscal year 2022.
Senator Murray. Okay. Thank you very much. I look forward
to working with you and hearing more about that.
Senator Blunt.
Senator Blunt. Thank you, Chairman.
ARPA-H FUNDING LEVEL
Dr. Collins, on the ARPA-H budget request, $6.5 billion,
one part of the question will be, how do you think that number
was arrived at, and is that a realistic number to commit in
year one?
And two, our concern would also be that we do not get in a
position that--we have already given NIH $6.5 billion and level
fund everything else. I do like the President's $2.5 billion. I
am sure you could figure out how to spend more than that in the
other institutes. That is pretty close to the average of the
last 6 years from our committee. I would certainly like to stay
at least at that level.
But, how do you think those two numbers compete with each
other? And how do you feel about actually being able to commit
$6.5 billion in that first fiscal year of ARPA-H?
Dr. Collins. That is a great question, Senator, and we have
thought a lot about it. I am pleased the President's budget
proposes that this would be 3-year money because, obviously,
you are going to start from a standing start whenever the
budget actually gets approved for fiscal year 2022. We hope
that will be September 30th, right? Well, it might not be. So,
at any rate, we would then really be benefitted by being able
in that first year to stretch those dollars over a little bit.
I do think we could, with a hundred program managers,
readily come up with a number of projects that would fit within
that envelope on an annual basis. But, I hear what you are
saying about a concern because I have heard it also that this
might in some way compromise the interest of the Institutes. I
guess I would look at it a different way, though.
As I said earlier, every one of the Institutes is coming
forward with great ideas about how they would like to use ARPA-
H. They think of this as an augmentation of their capabilities,
not a subtraction. And, so, they will be feeding ideas into
this and have a lot to do about how those are chosen. So, even
though the base number that is being proposed, $2.5 billion for
the ICs (NIH Institutes and Centers), may sound like a sort of
average one, in terms of the science they can do, ARPA-H is
going to add to that.
Senator Blunt. All right. Thank you.
ARPA-H AND CANCER RESEARCH
Well, Dr. Sharpless, one of the things the President, of
course, talks about in this issue, in this topic, is more
rapidly moving toward ending cancer. Obviously, we want to do
that. We also want to make the point that that is not the only
thing that ARPA-H would be focused on, nor would it just be
cancer or Alzheimer's. But, on that topic, how do you envision
the ARPA-H role in cancer research and what might you be able
to do with ARPA-H that you are not able to do in the
traditional restraints of the National Cancer Institute?
Dr. Sharpless. Thank you for the question, Senator Blunt.
It is great to be testifying in front of this committee again.
Good to see you virtually, at least, today.
Yes, as the President has said, ending cancer as we know it
is a top domestic priority for this Administration. We are
obviously, the cancer research community, is galvanized by this
notion and very excited.
I think, as you know, the National Cancer Institute does
some things really well. You know, we fund basic foundational
science very well. We can do clinical trials quite well. But,
there are some areas where we are challenged, where we have
struggles, and I think the scale and nimbleness and ability to
interact with industry is very appealing about ARPA-H for
certain kinds of cancer projects.
I think a good example of that is this blood-based cancer
detector technology that Dr. Collins mentioned in his opening
statement where you can, you know, find cancers at a very early
stage in otherwise asymptomatic, healthy people, and that could
have a profound effect on cancer mortality.
So, you know, getting up a huge trial of that technology as
quickly as possible is the kind of thing that I think would be
a good fit for ARPA-H.
Senator Blunt. Okay. Thank you, Dr. Sharpless.
RADX PARTNERSHIPS
Dr. Tromberg, let me see if I can get one more question in.
I think what you were part of at RADx is one of the reasons
that gives me real optimism about new kinds of relationships
that we might develop at ARPA-H. But, would you talk just a
little bit about RADx and how that partnership continued right
through the entire process of these companies that you were
choosing to invest money with, going ahead and making the first
home-based test, and I think producing well over two million
tests every day now, in addition to the tests that would have
come through the regular process?
Dr. Tromberg. Yes. Thank you so much, Senator Blunt, and
thank you for your question and for your generous support of
the RADx program.
The bioengineering-technology community has formed
partnerships all across the government. That has included
working with BARDA, FDA, DOD (Department of Defense), CDC
(Centers for Disease Control and Prevention), HHS (Department
of Health and Human Services), and the White House Testing
Board. More than 900 scientists are working across government,
academia, and the private sector in a very unique way to make
this work.
And, as you have mentioned, if we fast-forward to now,
about 1 year later, we now have 33 RADx-supported companies
that have increased the Nation's testing capacity by more than
300 million new tests, and there have been 23 new FDA
authorizations. And we have really changed the dialogue from
laboratory testing of symptomatic folks to over-the-counter,
widely available tests, point-of-care tests that are accessible
to all. Greater choice and greater capabilities. And this has
really happened because of all of these partnerships that we
formed, the accelerated innovation.
We have brought out new technologies. About 20 percent of
our portfolio actually--not many people know about--has been
based in nanoscience and nanotechnology.
Senator Blunt. Good.
Dr. Tromberg. So it has been a tremendous surge for
innovation.
Senator Blunt. Thank you, Doctor.
Thank you, Chairman.
Senator Murray. Yes. Senator Reed.
Senator Reed. Thank you very much.
I want to welcome all the panelists and thank them for
their distinguished service to the Nation, particularly during
this difficult and challenging COVID pandemic.
Dr. Collins, one of the things that is becoming
unfortunately and painfully obvious is the increase in
suicides, and this is very disturbing. And we are concerned,
also, about the impact of COVID-19 on accelerating, perhaps,
that phenomenon.
SUICIDE PREVENTION
So, the question I would have is, what research is NIH
doing on suicide prevention so that we can recognize the
warning signs, better communicate with friends and family, and
also give healthcare providers more insight? I am told that
many suicide victims visit emergency rooms frequently before
their suicide and those signs are not picked up. So, your
comments would be appreciated.
Dr. Collins. Well, I appreciate the question, Senator, and
it is a source of great concern and obviously great heartache
for the way in which this is taking a toll amongst people
across our Nation, and certainly at a time where mental health
issues have been even further heightened by all the stresses of
COVID-19. One can see this also becoming even more of a threat
to people who have lost hope.
NIH is deeply engaged in trying to understand ways to
prevent this terrible outcome, and the National Institute of
Mental Health has in fact invested in a number of new
initiatives as a result of that concern.
One that I would point to that has turned out to be a
pretty encouraging development is the recognition that the drug
Ketamine, which is used in anesthesia and sometimes used as a
party drug, unfortunately. It also turns out to have benefits
for people with serious depression, including people with
suicidal ideation. Now approved by FDA, and the drug
Esketamine, this is now available and it is being used in those
acute situations of acute suicidal threat.
You also mentioned that many people who are on the brink do
end up visiting healthcare facilities. We have worked hard to
try to make sure that this idea of having a screening tool that
was used in emergency rooms for individuals who are there, even
if they do not appear to be there for psychiatric reasons, gets
used to identify, particularly with adolescents, whether they
might be in a situation of contemplating self-harm.
On top of that, certainly NIMH is investigating other means
of treating depression, and also thinking hard about other
interventions that might be beneficial here in terms of
cognitive behavioral therapy combined with pharmacotherapy to
try to assist those individuals who are in this difficult
place. But, it is a terribly difficult problem.
I will say, it is interesting, but it is not necessarily
that encouraging, the actual suicide rate, as best we know, in
the course of the last year has not gone up. It has actually
gone down slightly, and that has tended to be the case in
national crises before. But, what I worry about is what happens
when we seem to be getting past the crisis, is there a pent up
backup there that might in fact result in an even greater risk
in the coming months.
I would be glad to give you more information. I am sure Dr.
Gordon would, as well, in terms of all the things that we are
doing.
Senator Reed. Thank you very much.
LONG COVID
Very quick question to both--to Dr. Fauci. The long haul
COVID-19 is beginning to trouble a lot of people. They never
seem to be able to recover from it and recurrences. What
attention are we paying to that issue?
Dr. Fauci. Thank you for that question, Senator. We are
paying a considerable amount of attention to it. In fact, we
have a program to the tune of $1.15 billion, looking at
developing cohorts of individuals so that we can study them for
the incidence, the prevalence, underlying pathogenesis, and, if
possible, if we can find this out, anything that we can do from
an intervention. So, the NIH is taking this very seriously.
Thank you.
Senator Reed. Thank you very much.
I have to commend Dr. Sharpless for his efforts on
childhood cancer. I was teamed up with Senator Capito. We
passed the Childhood Cancer STAR Act. We have been funding it,
thanks to the Chairwoman, at $30 million a year, and I want to
commend NIH on its renewed emphasis on childhood cancer, not
only treatments, but also gathering data about these victims as
they age so that we can see if there is any interventions that
we can use later on. So, thank you, Dr. Sharpless, and thank
you, panelists. Thank you very much.
Senator Murray. Thank you. Senator Graham.
Senator Graham. Thank you, Madam Chairman.
VACCINE DEVELOPMENT
The vaccine, developing the vaccine as fast as we did, what
is your biggest takeaway, Dr. Collins? How did we do that? And
how can we do it again if we have to?
Dr. Collins. It is really important to look and see that
this was built upon decades of research in basic science that
many people might have said would not probably end up being as
relevant as it turned out to be.
Senator Graham. So, all of our money in the past paid off
here, right?
Dr. Collins. Absolutely. This committee, and then the
Congress, especially over the course of the last 6 years where
you have increased the NIH support by 40 percent, has made it
possible for us to do a lot of things that otherwise we would
still not have been able to start. So, yes, it is all built
upon that foundation.
Senator Graham. Do you feel like the budget request being
made is enough to continue to build on what we have done?
Dr. Collins. I am very supportive of the President's budget
request, as you might expect I would be. And I am particularly
excited about this new proposal of ARPA-H, a new component of
NIH that would give us kind of a DARPA attitude that we could
bring to projects that are waiting for that kind of
opportunity.
Senator Graham. Well, I just hope we can memorialize what
we did to get the vaccine out so quickly.
GLOBAL VACCINE DISTRIBUTION
The developing world--Dr. Fauci, one thing I worry about is
getting the vaccine out into the developing world, particularly
Africa. What can we do better in that regard? And why should
we?
Dr. Fauci. Well, first of all, the answer to your second
question, which is very relevant, Senator, is why should we?
And the reason we should is that a global pandemic requires a
global response. And even though, as you well know from the
numbers, we are doing extremely well in this Country--we now
have over 60 percent of adults having at least one dose, and
about almost 50 percent of the adult population in this Country
fully vaccinated.
However, even if we get this pandemic under control, which
I believe we will within a period of a few months, there is
always the danger, when you have viral dynamics in other parts
of the world, for the generation of variants that might
actually undermine the protectiveness of the vaccines that we
have.
Senator Graham. So, it is in America's interest to get the
vaccine out to as many people as possible?
Dr. Fauci. It is absolutely to our interest. I believe--not
only do I think it is a humanitarian, moral responsibility, but
it is in what I call enlightened self-interest for us to do
that.
ORIGIN OF COVID-19
Senator Graham. So, let's talk about our enlightened self-
interest for a moment. Has there ever been a pandemic that we
know of that started in a laboratory somewhere?
Dr. Fauci. To our knowledge, no.
Senator Graham. Okay. If this were in fact a breach of
protocols in China, if it did come out of a lab, that would be
a first for the world; is that right?
Dr. Fauci. I believe so. There was a situation with an
influenza where there was a suspicion that it might have
escaped from a laboratory in Russia.
Senator Graham. But this----
Dr. Fauci. But that has never been validated or confirmed.
Senator Graham. So, have we found any animals that carry
COVID-19 that could have been the source of the transmission to
humans thus far?
Dr. Fauci. Thus far, not. I mean, if what you are referring
to, Senator, is an intermediate host----
Senator Graham. Right.
Dr. Fauci [continuing]. We know clearly, for example, with
SARS-CoV-1 that a bat virus went into a civet cat, which then
transmitted it into the human population. With MERS, it was a
bat to a camel to human.
The intermediate host, if there is one, has not yet been
found.
Senator Graham. And we have been looking for that
intermediate host; is that fair to say?
Dr. Fauci. That is fair to say, sir.
Senator Graham. At what point in time would it become more
likely it came from the lab if we do not find an intermediate
animal host? How much longer?
Dr. Fauci. I do not think we can give a time element on
that, Senator, for the simple reason we still have not yet
confirmed what the host is from Ebola. We know that Ebola jumps
from an animal reservoir to human, and it has been many years
now since the original Ebola outbreaks, and we have not yet
nailed that down.
Senator Graham. But we believe that Ebola did not come from
a lab?
Dr. Fauci. Yes.
Senator Graham. Okay.
Dr. Fauci. Yes.
Senator Graham. So, I guess my point is, who should look,
what should we be doing to make sure we find out how it
started?
Dr. Fauci. Right.
Senator Graham. And finally, what should be the
consequences to any country, China included that allowed this
to happen? What should the world expect of a country if they in
fact allowed this virus to come from one of their labs through
negligence?
Dr. Fauci. Well, first of all, when you said, who should,
you know, the WHO (World Health Organization) did what they are
referring to now as phase one of an investigation, which they
felt was not completely adequate, as you know. You have heard
me and Dr. Collins and others in the Administration calling for
a continuation of the investigation.
I do not think I can comment on your second question. It
would have to be the circumstances under which something like
that happened, if indeed it happened.
Senator Graham. Well, just very briefly--I know my time is
out--I think we should send a clear signal to China--seems to
be a source of a lot of pandemics--that if this did occur in
the lab, expect something to happen because if we do not, we
are just going to reinforce this in the future. And what that
something is, I am open-minded to, but I am closed-minded to
the idea of doing nothing.
Senator Murray. Thank you. Senator Shaheen.
Senator Shaheen. Thank you, Madam Chairman, and thank you
to you, Dr. Collins, and everyone at NIH for all of your hard
work over the last very difficult year and for everything else
you are doing.
ARPA-H AND DIABETES
As you are aware, diabetes is one of the most expensive and
pervasive of our chronic diseases, and I was pleased that in
the authorization at the end--re-authorization at the end of
the year, we funded the Special Diabetes Program for 3 years
and the work that is being done to advance treatment for Type
1.
But, can you talk about this new ARPA-H agency and to what
extent it might be looking at ways to help address diabetes?
Dr. Collins. I would love to, and thank you for the
question, Senator. This is the hundredth anniversary year of
the discovery of insulin, so we have come a long way in those
hundred years, but we are not where we really need to be to say
we have conquered this one.
ARPA-H, because of its ability to tackle problems in a
team-oriented, nimble way, offers us some new opportunities
here. Certainly, one of the ones that the Diabetes Institute
has been promoting to me of late, sending me ideas, is to
transform the way that we actually develop and test
therapeutics, shouldn't we at this point be able to come up
with therapeutics for diabetes that do not require injections.
A totally new approach to how we would treat this disease.
Another one that I am excited about, and I know you have
done a lot of encouragement about this, is the artificial
pancreas.
Senator Shaheen. Right.
Dr. Collins. And we have made real progress there, Senator.
But, I think we could go a lot faster if we had this
coordinated, ARPA X kind of attitude brought to this, both for
artificial pancreases that are built on engineering and sort of
a feedback loop that gives insulin when it needs to, but maybe
even more so the ones that built upon the patient's own stem
cells that can be converted into that.
Senator Shaheen. And how do we make sure that diabetes is
one of those diseases that ARPA-H addresses?
Dr. Collins. Well, fortunately, because I think we do have
a pretty good budget being proposed here, and diabetes is
already mentioned by the President as one of the three areas of
interest, I think diabetes is extremely likely to be on the
list.
Senator Shaheen. Good. Thank you. I am glad to hear that.
COVID-19 VACCINE BOOSTER SHOTS
Dr. Fauci, the question that everybody is asking is, are we
going to need a booster shot to complement our COVID
vaccination? Do you have any sense of that and what the timing
might be for that?
Dr. Fauci. Two parts to that question, and they are
separate but important. I do not anticipate that the durability
of the vaccine protection is going to be infinite. It is just
not.
Senator Shaheen. Right.
Dr. Fauci. So, I would imagine we will need at some time a
booster. What we are figuring out right now is what that
interval is going to be. We know from studies following people
from the original clinical trials that the protection goes out
at least 6 months, and likely a year. But, we do not know right
now how long that will be.
So, what we are doing is we are following those cohorts
because there is a level of protection that is called a
correlate of immunity, and we know that if you are above that
level, you are in quite good shape to be protected.
The vaccine itself gives you a level up here. So, how long
it takes to start coming back down, we are following it, and
two ways of understanding that. One, does, from a lab
standpoint, it get below a certain level; or, do we start
seeing a lot more breakthrough infections. Either of those
would be a trigger. But, we are following that very carefully.
So, in answer to your first part of your question, I
believe we will need a booster. I am not exactly sure when.
Senator Shaheen. Thank you.
SUBSTANCE USE DISORDER AND METHAMPHETAMINE RESEARCH
And, Dr. Collins, you may remember that New Hampshire is
one of the hardest hit States by the substance use disorder
epidemic. And we have seen a decline over the last year because
of the pandemic, but we have also seen a replacement of many of
those opioids by meth. I think there is a belief among some
people who use substances that meth cannot kill you in the same
way that an opioid can. And, yet, as I talk to providers, they
tell me there are very few treatments that they have available
to them to deal with meth.
So, can you tell me what the National Institute on Drug
Abuse is doing to try and address the meth piece of substance
misuse?
Dr. Collins. Absolutely. This is an area of intense
interest and concern because what was primarily an opioid
crisis is now very much becoming a mixed crisis of opioids and
stimulants, and particularly methamphetamine.
I was pleased to see that NIDA (National Institute on Drug
Abuse) ran a trial, a phase three trial, on treatment for
methamphetamine addiction, which is a combination of injectable
Naltrexone and oral Bupropion, and showed benefit. We have not
previously had anything to offer to help people who are
addicted to meth. That is one step forward.
We also now are running this effort to vaccinate people
against methamphetamine. I know that sounds odd, but you could
immunize against that compound in a way that it would no longer
provide anybody much of a benefit if they decided to use it
anyway. We are doing that for heroin and Fentanyl, and we are
doing it for meth. But it is very helpful.
Senator Shaheen. Excuse me for interrupting. Does that work
if people have already been users?
Dr. Collins. It will. So, basically, getting your immune
system to make an antibody so that in the future, if you
encounter that drug, it cannot get to your brain because the
antibodies grab onto it.
Senator Shaheen. I will have to learn more about that.
Thank you. My time is up.
Thank you, Madam Chair.
Senator Murray. That is very interesting. Thank you.
Senator Kennedy.
Senator Kennedy. Thank you, Madam Chairman, Chairwoman.
GAIN-OF-FUNCTION RESEARCH IN CHINA
Dr. Fauci, I believe you have testified that you did not
give any money to the Wuhan lab to conduct gain-of-function
research. Is that right?
Dr. Fauci. That is correct.
Senator Kennedy. How do you know they did not lie to you?
Dr. Fauci. Excuse me, sir?
Senator Kennedy. How do you know they did not lie to you
and use the money for gain-of-function research anyway?
Dr. Fauci. Well, we have seen the results of the
experiments that were done and that were published and that the
viruses that they studied are on public databases now. So, none
of that was gain-of-function, so----
Senator Kennedy. How do you know they did not do the
research and not put it on their website?
Dr. Fauci. There is no way of guaranteeing that, but in our
experience with grantees, including Chinese grantees, which we
have had interactions with for a very long period of time, they
are very competent, trustworthy scientists. I am not talking
about anything else in China. I am talking about the
scientists. That you would expect that they would abide by the
conditions of the grant, which they have done for the years
that we have had interactions.
Senator Kennedy. So you do not think the Chinese would lie
to you?
Dr. Fauci. Well, when you say the Chinese, the Chinese are
a rather broad group. I know the scientists that we have dealt
with have been trustworthy.
Senator Kennedy. You think all the scientists have told the
truth in terms of the origin of the Wuhan virus and not been
influenced by the communist party of China, do you?
Dr. Fauci. I do not have enough insight into the communist
party in China to know the interactions----
Senator Kennedy. Right.
Dr. Fauci [continuing]. Between them and the scientists,
sir.
Senator Kennedy. Right. Why are we giving them money in the
first place?
Dr. Fauci. Well, that is a very good question, and thank
you for giving me the opportunity to----
Senator Kennedy. You are welcome.
Dr. Fauci [continuing]. Answer it. Well, SARS-CoV-1 started
in China in Guangdong Province, and it went from a bat to a
civet cat to a human.
Senator Kennedy. Yes, and excuse me, Doc, for interrupting
you, but our time is so limited.
Dr. Fauci. No, no. I am going to be real quick.
Senator Kennedy. Our time is so limited. Why are we giving
money to the labs in China to study virology?
Dr. Fauci. Well, I am going to give you a rather succinct
answer to that, sir.
Senator Kennedy. I would appreciate that.
Dr. Fauci. And that is why I was saying the SARS-CoV-1,
clearly the bats that have the viruses that are the
coronaviruses are in China. As I said a couple of times, it is
not in Fairfax County, Virginia or is it in New York. It is in
China. So, if you want to show and study importantly the
animal-human interface, the viral----
Senator Kennedy. Because that is where the bats are?
Dr. Fauci. Yes, the bats.
Senator Kennedy. Okay. I got it.
Dr. Fauci. That is where the bats are.
Senator Kennedy. I want to be sure I understand your
testimony. You did not give money to the Wuhan lab to do gain-
of-function research?
Dr. Fauci. That is correct.
Senator Kennedy. And you believe they did not do gain-of-
function research because they told you they did not?
Dr. Fauci. We have seen the results of the studies that
they conducted and they were not gain-of-function.
Senator Kennedy. Including any private studies?
Dr. Fauci. Excuse me? Including?
Senator Kennedy. Any private studies.
Dr. Fauci. I am not sure what you are getting at, sir.
Senator Kennedy. Here is what I am getting at. You gave
them money and you said, don't do gain-of-function research.
Dr. Fauci. Correct.
Senator Kennedy. And they said, we won't?
Dr. Fauci. Correct.
Senator Kennedy. And you have no way of knowing whether
they did or not except you trust them; is that right?
Dr. Fauci. Well, we generally always trust the grantee to
do what they say, and you look at the results----
Senator Kennedy. Have you ever had a grantee lie to you?
Dr. Fauci. I cannot guarantee that a grantee has not lied
to us because you never know.
Senator Kennedy. Yes. Can we agree that if you took
President Xi Jinping and turned him upside down and shook him,
the World Health Organization would fall out of his pocket?
Dr. Fauci. I do not think I can answer that question, sir.
I am sorry.
Senator Kennedy. Well, do you think President Xi Jinping
has undue influence over the World Health Organization, do you?
Dr. Fauci. I have no way of knowing the influence of the
president of China over the WHO.
Senator Kennedy. Okay. So you think the WHO is a completely
independent body and level playing field, call-it-like-you-see-
it, and they really want to get to the bottom of the origin of
the virus? Do you believe that?
Dr. Fauci. My interaction with the WHO and for Dr. Tedros,
the Director General, has been one----
Senator Kennedy. Okay.
Dr. Fauci [continuing]. That I do believe he is a person of
high degree of integrity.
INVESTIGATION INTO ORIGIN OF COVID-19
Senator Kennedy. I got it. I want to ask one last question.
Why did you guys spike--not guys, and ladies. Why did you all
spike the prior administration's investigation into the origins
of the coronavirus and whether it could have come out of the
Wuhan lab?
Dr. Fauci. Sir, I--we did not spike anything in the prior
administration. I am not sure what you mean by spike. But, we
have no influence----
Senator Kennedy. The State Department spiked the prior
administration's study.
Dr. Fauci. But that has nothing to do with the National
Institutes of Health.
Senator Kennedy. So they did not consult with you all?
Dr. Fauci. They did not.
Senator Kennedy. Did they consult with you, Dr. Collins?
Dr. Collins. I read about it in the press this morning.
Senator Kennedy. Doc.
Dr. Bianchi. No.
Senator Kennedy. They just spiked it without talking to
their experts?
You do not want to answer that one, do you?
Dr. Collins. I just read about it.
Senator Kennedy. Thank you, Madam Chair.
Senator Murray. Senator Murphy.
Senator Murphy. Thank you very much, Madam Chair.
Listen, the World Health Organization is the most
influential global public health institution in the world,
whether my friends like it or not. They have more people and
more influence on the ground across the world than anybody
else, including the United States.
And, so, if the complaint is that any country, including
China, has too much influence, the answer is not for the United
States to walk away. The answer is for the United States to
double down and make sure that any grievances we have are
addressed. Otherwise, the problem for which you are identifying
is exacerbated by the United States not being at the table with
the WHO.
And while the major donors to that organization certainly
have lots of influence, as is the case with every international
organization, it is an oversimplification to suggest that they
are in the pocket of the Chinese government. China has
influence. The United States has influence, as well, so long as
we are at the table.
FIREARMS RESEARCH
I have two areas to cover, and the first I wanted to raise
with you, Dr. Collins, and that is around the budget request to
double the firearm injury and mortality prevention research
account. Let me place myself solidly behind that request. Thank
you for making it, and I was hoping you might--I apologize if
you have gotten a question on this already. I have been
listening but in and out a bit.
I am hoping that you might be able to talk a little bit
about how you might prioritize that additional funding,
especially as it might relate to research on community-based
interventions and what works and what does not. And, then, you
know, how to make sure that all that information gets out to
community partners, folks who are boots on the ground, maybe
not the exact set of players that NIH is used to disseminating
information to.
Dr. Collins. Well, I appreciate the question, and we are
enthusiastic about expanding our approach and the amount of
funds we can put into research on firearm violence. After all,
some 40,000 deaths happen each year from firearms. About 60
percent of those are suicides, which is another topic that came
up earlier and is also part of our suicide prevention, is to
think about availability of guns.
I think you are right, though, that community approaches
are very much ripe for this kind of approach, where you might
not just try to change one thing in the community, but see if
by coordinating the efforts across multiple different ways in
terms of making sure that firearms are not accessible to those
people who might misuse them; in terms of particularly
adolescent and youth risks of violence and how to intervene.
Maybe we could take an approach that would be more holistic
as opposed to trying to fix one thing at a time. With a larger
amount of funding here and a community focus, I think we might
be able to do that.
Senator Murphy. The President has proposed, I think, $5
billion to support these community-based interventions. Maybe
some of that will be used for assessment and study. But, given
the fact that I think we probably can get bipartisan agreement
about supporting these investments in prevention, it really
would be helpful to use some of this increased funding to
assess which ones work and which ones do not.
SOCIAL DETERMINANTS OF HEALTH
Second broad topic, and maybe I will address this both to
Dr. Collins and I think, via video, Dr. Perez-Stable, is on the
topic of social determinants of health. And I am just
interested to hear a little bit about how we have adjusted
research based upon our growing understanding that people's
health is dictated by where they live and how much money they
make and how close they are to pollution sources.
My sense is that, you know, this is not an easy sort of
thing to incorporate into a research community that is sort of
used to working in labs and not always used to thinking about
how factors outside the body impact health. What have we
learned? How has that changed the way that we fund research and
encourage applications to come to NIH that might support social
determinant research?
Dr. Collins. I am going to ask Dr. Perez-Stable to respond.
Dr. Perez-Stable: Thank you, Dr. Collins, and thank you,
Senator Murphy, for that important question.
At the National Institute on Minority Health and Health
Disparities, and throughout NIH, the topics of social
determinants of health have always been present. We consider
self-identified race and ethnicity and socioeconomic status
standard measures to be fundamental factors that influence
health in ways that we do not really understand, and that is
why we believe that all research with human beings should
measure these routinely and follow them.
In addition to these two, though, there are other
demographic and individual social determinants of health, of
which many are issues related to age and gender, sexual
orientation, but then structural social determinants of health
that you refer to. Where one lives, plays, and prays, relate to
both transportation, housing, and issues around green space
and, of course, Internet access, which has become incredibly
important, as we know, in the last year. So, we have these
fundamentally incorporated into our standard research, and
community engagement is really part of everything that we do at
NIMHD, and increasingly across the Agency.
Senator Murphy. Well, thank you for that. I appreciate the
new focus you are putting on this. Again, this is an area of
potential bipartisan agreement. Senator Sullivan and I have
legislation in this space and look forward to working with you
on it.
Thank you, Madam Chair.
Senator Murray. Thank you. Senator Shelby, are you ready?
You want me to----
Senator Shelby. Yes, I am ready.
Senator Murray. Okay.
Senator Shelby. I just got here. Thank you. I have been at
another hearing, and this question may have been asked.
Dr. Collins, always good to see you.
Dr. Collins. Likewise.
Senator Shelby. I agree with a lot of people on this
committee that the money we put in to biomedical research
benefits mankind, period. Not just our people, but the world,
what it has taught.
AUTOIMMUNE RESEARCH BREAKTHROUGHS
Two or three promising areas, biomedical research in the
area of autoimmune--that is a big, big topic. You know it
better than anybody. What are we--what are the breakthroughs
there, the hopes, in two or three of those top areas?
Dr. Collins. Well, thank you, Senator. It is good to see
you, and I know you are running from one place to another. I am
glad you are here.
I just had a wonderful experience yesterday afternoon
listening to presentations from a consortium of researchers
that we have funded jointly with industry. So, this is called
the Accelerating Medicines Partnership, and it is focused on
rheumatoid arthritis and lupus.
What they have done is to take this field, which was
looking at immunology in a way that was pretty cutting edge 5
years ago, and now completely transformed it by looking at
individual immune cells in the synovium of people with
rheumatoid arthritis--the lining of the joint--and say, what
are you doing there, immune cells, and how does that teach us
what the real pathogenesis about----
And for lupus, they are looking at kidney biopsies,
because, of course, lupus affects the kidney and that is one of
its serious consequences. Same thing, looking at individual
cells.
It has completely revamped our understanding of these
diseases. We have learned, for instance, that the pericyte,
which was just sort of a cell that we thought was hanging out
watching in the kidney of somebody with lupus, might be the
driver of what is really happening there as far as the immune
response. This is not p-a-r-a. This is p-e-r-i, cyte, in case
that is not clear. For rheumatoid arthritis, it is the
fibroblasts.
And we are so excited about this. We are now planning to
expand that same approach to other autoimmune diseases, to
psoriasis, to psoriatic arthritis, to Sjogren's Syndrome, and
maybe others, as well.
So, you hit me at a great moment. I was so jazzed yesterday
to see what has been possible.
Senator Shelby. All based on bacteria, is it?
Dr. Collins. It is all based on this ability to look at
single cells, one at a time. We have not really been able to do
that until about 5 years ago. We would have to look at
thousands of cells and try to infer what was there, and now you
can ask each one. And the cell is, after all, the basic unit of
all life, and it has been outside of our reach, but not
anymore.
Senator Shelby. What could that do for the autoimmune area?
Dr. Collins. I think it can have a huge impact because we
now have new targets coming out of this recognition that I
think in the next 4 or 5 years, we are going to see a whole new
generation of drugs for autoimmune diseases based upon that
insight that is just now emerging.
CYSTIC FIBROSIS RESEARCH
Senator Shelby. I brought this up many a time, but in the
area of cystic fibrosis, there have been so many breakthroughs
in that area, extending children's lives, adults' lives, and
everything. Where are we going there? We have come a long way,
but we are not there yet.
Dr. Collins. We are not completely there, but, oh, boy,
have we come a long way, especially in the last 2 years now
with this 30-year effort, and I have been deeply engaged in
this having had a role in----
Senator Shelby. I know.
Dr. Collins [continuing]. Discovering the gene back in
1989. And, now, we have this triple drug therapy, which for 90
percent of patients with cystic fibrosis is dramatically
beneficial. I get messages almost every week from somebody who
was really in tough shape, and now they are back at work; or
somebody who was on a transplant list, and now they were taken
off of it because their lungs are doing so much better.
But, there is still that 10 percent. This is where I think
the gene-editing approach, where you actually figure out how to
fix that misspelling of the cystic fibrosis gene in the lungs
of somebody who is affected, might be the way to get to 100
percent, and there is a lot of work going on that.
LUPUS RESEARCH
Senator Shelby. What promises are out there that you have
talked about before dealing in lupus, which is an autoimmune
disease?
Dr. Collins. Well, as I mentioned, we have this ability now
to be able to see individual immune cells, what are they up to
in lupus, both in the kidney and in other areas, as well. I
think that is teaching us some new things about what the real
fundamental cause is. And it will tell us that some of the
treatments we have been giving, like steroids, are kind of a
little bit too much of a sledgehammer, and what we need now is
something much more subtle to go after the fundamental problem.
We have a better chance at that now.
PANCREATIC CANCER RESEARCH
Senator Shelby. What about the area of pancreatic cancer?
That is a fast-moving thing, I know.
Dr. Collins. It is, indeed. And if Dr. Sharpless is
listening, maybe he would like to quickly give a response since
that is his area at the Cancer Institute. Ned, are you there?
Dr. Sharpless. Sure. Yes. Thank you, Francis.
Pancreatic cancer is an area where we have not seen the
success that we have seen in other cancers, but it is not for
lack of good ideas. So, there are a number of----
One of the realizations is that pancreatic cancer comes in
lots of flavors, and each one needs its own treatment. So, now
we are working on the subset approach to pancreatic cancer. I
think there is also a real opportunity to detect pancreatic
cancer earlier at a more curable stage.
So, I think those are the exciting areas of pancreatic
cancer research.
Senator Shelby. Thank you. I would like to get in--I know
my time is moving on. The chairperson has been very kind.
CTSA PROGRAM
Dr. Collins, in the area of the CTSA Program, the Clinical
and Translational Science Award Program. The CTSA hubs and
their partners, I think, have done a lot of good work in that
area, and valuable work, especially during the COVID-19 thing.
It is my understanding that the NIH, National Institutes of
Health that you head, is considering significant changes to
that program that would discourage hubs, like UAB, for example,
in Birmingham, from forming partnerships with certain non-
clinical universities in research questions.
Is this true, and why is that?
Dr. Collins. That is not a correct assumption. I know there
are some rumors flying around about that, and there will be a
public announcement about this.
Basically, just, without trying to get too far ahead of
what has not been revealed publicly, I think we are trying to
simplify the application process to make it easier for those
hubs, and we intend to keep them going in vigorous ways; to
apply when they are up for renewal in a way that does not
require an application of 2,000 pages, which is what it has
been. But, we would not want to do anything to discourage these
collaborations that you are mentioning. Take that from me.
Senator Shelby. Thank you. Madam Chair, thank you.
Senator Murray. Thank you. Senator Manchin.
Senator Manchin. Thank you, Madam Chairman, and thank all
of our presenters. I appreciate very much them being here.
DOMESTIC DRUG SUPPLY CHAIN
My first question will go to Dr. Fauci. The Food and Drug
Administration reports that nearly 40 percent of finished drugs
and roughly 80 percent of active pharmaceutical ingredients are
manufactured abroad. During the COVID-19 pandemic, we saw
factories shut down in order to prevent the spread of virus,
drug supply chains disrupted, and drug shortages increase. As a
result, America's access to essential medicines was really put
into jeopardy.
As a preeminent infectious disease doctor, you know better
than anyone how important it is to have access to essential
medicines. So, my question will be, Doctor, can you comment on
the importance of a strong domestic supply chain for essential
medicines? And how can we ensure we do not experience future
drug shortages when the global supply chains are disrupted?
Dr. Fauci. Thank you very much for the question, Senator
Manchin. I think it is absolutely critical that we have the
capability, independent of supplies from foreign countries, to
be able to supply the necessary medicines that we need in the
United States. I have been of that opinion for a very long
period of time.
The solution to the problem is to be doing much less of the
outsourcing to foreign countries for the important ingredients
of many of our medications. So, right now, we are not in that
good position, and I believe, particularly since the
disruptions of the supply chain that have occurred with the
COVID-19 pandemic, that this might be a good lesson for us for
the future to make sure we have much more dependency on what we
can do domestically as opposed to in foreign nations.
Senator Manchin. Doctor, have you all looked at why? Why
has most of the manufacturing left the United States and why
are we not able to manufacture? Are we at a disadvantage in the
United States for other reasons, cost wise, or basically
different types of things, that we make people jump through
hoops and everything else as far as permitting and all that?
What would be the cause?
Dr. Fauci. You know, Senator, to be honest with you, I do
not know why that has happened. I think it was because it was
felt it would be much less expensive to get this done outside,
but I do not really know the answer to your question of why we
have so much of a dependency of important materials outside of
the Country. But, certainly, whatever the reason, I believe it
needs to be corrected.
Senator Manchin. Well, I need to work with you on that,
Doctor, if I can, basically, in making sure this
Administration--I think they understand the urgency we need to
start basically manufacturing again, not only just our drugs,
but so many things in our Country. So, I look forward to your
support on that.
RURAL HEALTH OUTCOMES
Dr. Collins, West Virginia is constantly ranked last in the
Nation for health outcomes. In 2020, the America's Health
Rankings reported my State of West Virginia 50th for premature
deaths, frequent mental distress, and multiple chronic
conditions. We also ranked last in life expectancy.
What is the NIH doing to bridge this gap in health
outcomes? And how do you ensure that the medical research that
you do benefits people in poor, rural communities?
Dr. Collins. Well, it is very troubling to see the fact
that you have just cited that health outcomes are not what we
would all want them to be. And, of course, there are many
factors that play into that, Senator, and we are deeply engaged
in research in trying to identify the ones that are
addressable.
Certainly, one of the things I might point to is the
increasing focus we have on disease prevention. If we simply
are limiting ourselves to trying to help people who have
already developed a serious disease, we have kind of missed the
opportunity. Unfortunately, our healthcare system does not do a
great job in that situation of providing support for disease
prevention, and it seems happier to pay for things once people
are already quite ill, so there is additional work that needs
to be done there.
One of the things that I think I would point to is a series
of large-scale efforts to really understand what are the
factors that play out in people staying healthy or getting a
chronic disease or how you manage that.
The All of Us Program, which this Congress has supported,
on the way to enrolling a million participants, including in
West Virginia, is a way in which we can collect that kind of
evidence, including their electronic health records and lots of
information about their environmental exposures, and try to
figure out in a holistic way, how can we take that information
and bring forward a better chance for people to live not just a
good lifespan, but a good health span. So, we are----
Senator Manchin. Thank you, Doctor.
Dr. Collins [continuing]. Deeply engaged.
Senator Manchin. Thank you, sir.
Dr. Fauci, finally, you know, my home State of West
Virginia is battling an epidemic during the middle of a
pandemic. We have been devastated by the drug epidemic, COVID-
19, and now--we now lead the Nation in new HIV infection rates.
You spent much of your career focused on prevention, diagnosis,
and treatment of HIV/AIDS, and your research has been
instrumental in saving countless lives in the United States and
around the world.
INFECTIOUS DISEASE SURVEILLANCE EFFORTS
So, Doctor, what is being done to replicate testing and
surveillance efforts we saw put into place for COVID-19 for
other infectious disease, like HIV/AIDS? And what public health
infrastructure would be required to bring better infectious
disease testing and surveillance to fruition?
Dr. Fauci. Thank you for that question, Senator. The HIV
testing situation, unfortunately, has been somewhat interrupted
by the COVID-19 pandemic because of the interruption of
multiple services.
But, as you know, we have a 10-year plan to end HIV as an
epidemic in the United States, and that is going to require
access to testing for those who are not infected to put them
on, if they are at risk, to pre-exposure prophylaxis; and those
who are infected to immediately put them on antiretroviral
therapy. Because, as we know, when you bring the level of virus
to below detectable, not only do you save the life of the
individual, but you make it essentially impossible for that
individual to infect someone else.
So, testing is really at the fundamental basis of how you
address the epidemic and, for that reason, it is going to be
extremely important to get our testing capabilities back up to
snuff once we get the Country back on a degree of normality
following control of the COVID-19 pandemic.
Senator Manchin. Thank you. Thank you, Madam Chairman.
Senator Murray. Thank you. Senator Braun.
Senator Braun. Thank you, Madam Chair.
Dr. Fauci, I was listening with interest in Senator
Kennedy's line of questioning, which probably was asking you to
maybe answer some things based upon what the WHO should do or
not.
INVESTIGATION INTO ORIGIN OF COVID-19
I would like to discuss something that is probably a little
simpler to answer in terms of transparency in general. From the
time I have known you and Dr. Collins, it has generally been in
this seat, and we have been talking about something related to
COVID. Would you agree that in the whole process of--now that
there are second thoughts on how this thing derived, that it
may have come from a lab, that we should emphasize as much
transparency as possible in pursuit of getting the answer?
Dr. Fauci. Without a doubt, Senator. No doubt.
Senator Braun. And the next logical question would be that
we do not know what we are going to get from the communist
regime or the WHO, but we do know that through our Director of
National Intelligence and probably DHS (Department of Homeland
Security), from Haines and Mayorkas, that they have probably
got information there. And, so, since you believe in
transparency, wouldn't you think that we should declassify all
the information that we own so that you, Americans, independent
researchers, can see what we have got to sort through how this
thing started?
Dr. Fauci. Well, Senator, I have said publicly and most
recently that I believe that there should be transparency, and
open, fair, and independent, continue to look. As I have said,
I still believe that the most likely scenario is that this was
a natural occurrence, but no one knows that 100 percent for
sure. And since there is a lot of concern, a lot of
speculation, and since no one absolutely knows that, I believe
we do need the kind of investigation where there is open
transparency and all the information that is available to be
made available to scrutinize.
Senator Braun. So, since you have been the point person on
just a variety of topics through the COVID saga, does that mean
then that you will ask President Biden to declassify that
information?
Dr. Fauci. I do not think I can promise you----
Senator Braun. But, I mean, would you ask him since you
believe in transparency? Wouldn't it make sense that we get the
information that we have? And I think if it does not come from
you, Dr. Collins, someone that has been in the mix from the
get-go, that we will not see it. And we owe it to the American
people with what we have been through to at least look at the
information that we have.
Dr. Fauci. Yes. I am not sure the information we have,
but--I am not sure if it is my place to tell the President of
the United States to declassify----
Senator Braun. But you have been very engaging on a wide
range----
Dr. Fauci. Right.
Senator Braun [continuing]. Of topics, and I think he would
respect your opinion as much as anyone.
Dr. Collins, where are you at on that subject of giving the
American people the information that we house?
Dr. Collins. Well, I am very much where Dr. Fauci is with
the desire to be as transparent as possible in this situation
and really try to find out what happened. I agree with him that
it is most likely that this is a virus that arose naturally,
but we cannot exclude the possibility of some kind of a lab
accident. That is why we have advocated very strongly that WHO
needs to go back and try again after the first phase of their
investigation really satisfied nobody, and this time we need a
really expert-driven, no-holds-barred collection of
information, which is how we are mostly really going to find
out what happened.
I am just not in a position to know what might be in the
classified documents and what else might be there that would
not be relevant to this and might actually be harmful to
national security. I get--I take your point. But, I know the
President is very interested, also, in seeing truth come out
here, so it may not require Tony or me to tell him that this
would be good, to make this as visible as possible.
Senator Braun. Well, I think for the American public, if we
are relying on the WHO to do it again, even though it seems
like they have had somewhat of an epiphany that we need to dig
deeper. I think if it does not come from the two of you to ask
for simply the release of information, of course, keeping
hidden anything that would be something that could not be
exposed. But, I am guessing there is a good bulk of that that
would be benign in terms of just the information we have about
the origin of the disease.
So, I think for many of us, many Americans, with what we
have gone through, we ought to at least be willing to look at
the information that we have to get people satisfied that we
are getting to the bottom of it. So, I would ask each one of
you to think about that and see if it makes sense, have our
President declassify it so we can see it.
Dr. Collins. Thank you.
Senator Braun. Thank you.
Senator Murray. Thank you. Senator Moran.
Senator Moran. Chairman, thank you.
Dr. Collins--well, Doctors, welcome. Good to be here with
you, and I appreciate your presence and your work.
Let me talk about clinical and translational science, if I
could. Under Dr. Austin's prior leadership, the National Center
for Advancing Translational Science at NIH has been essential
in facilitating clinical and translational research, and I have
seen it in Kansas. In fact, I have seen it with the director of
that directorate.
CTSA PROGRAM
In Kansas, NCATS' Clinical and Translational Science Award
Program has served for a catalyst to bring lots of
organizations in the research community and community partners
together to advance research.
I have concerns with potential changes that are under
consideration for the CTSA Program. In particular, changes that
would lower hub awards and limit CTSA partners.
Moving forward, will there continue to be consideration for
ensuring that CTSA centers are located in regions in the U.S.
which do not already have those hubs? There is already a
limited number in the Mid-West, and I would be concerned if any
new changes to the program that would make it more difficult
for these hubs to compete.
And, then, I would ask the question about partners. At the
University of Kansas, for example, they partner with Children's
Mercy, Kansas City University of Medicine and Biosciences,
Kansas State University, St. Luke's Health, University of
Kansas Health System, KU Office of Research, KU School of
Medicine in Wichita, and University of Missouri in Kansas City.
Since the CTSA Program is focused on partnerships between
regional research hubs and community partners, why would NCATS
limit the ability of the program, in my view, to accomplish its
goal?
Dr. Collins. Well, Senator, thank you for the question. I
am a big fan of the CTSA Program and enjoyed my opportunity to
travel to Kansas with you and see some of the things they were
doing a few years ago.
And this is, I think, one of those circumstances where
there seems to be some anxiety in the CTSA community about
something that has not actually been announced yet, and I would
like to be reassuring about this. The real intention of the
change that is being proposed is to de-complicate the renewal
process, which currently requires an application of about 2,000
pages that I do not think anybody enjoys putting together, and
to try to make this more straightforward.
There is no intention to reduce the number of hubs.
Certainly, every hub has to compete to show that they are
actually using the funds wisely, and we will continue that
process. And this notion that somehow the new process will
discourage collaborations with other institutions I find a
little hard to understand because I have no knowledge that that
is at all intended to be the case, and I would personally
oppose that.
Senator Moran. Thank you for your reassurance. My question
was more complicated than I wanted it to be, but your answer
was very comforting.
Let me ask just a couple of specific questions.
NCATS RARE DISEASE RESEARCH
What can this committee do to support NCATS' efforts to
enable and facilitate advanced important research in rare
diseases for patients living particularly in rural communities?
Dr. Collins. Well, the NCATS is deeply engaged in rare
diseases. Our former director, Chris Austin, not only was a
personal promoter of that; he was the head of the international
committee for rare diseases, and that tradition will continue
under Acting Director, Dr. Rutter.
Certainly, the support that this committee has provided to
NCATS to make it possible for that kind of investment to happen
in rare diseases, for which companies probably are not going to
make an investment because the market is too small, is one of
the reasons that we have now made really significant progress
in dozens of these rare diseases.
We are also engaged right now in a serious conversation
with industry about whether there is a way, with gene therapy
emerging as an even more attractive opportunity for rare
diseases, to make sure that we move that forward at all due
speed and not have it held up by such things as a limitation in
manufacturing of viral vectors.
So, they are right in the middle of that, and the support
that you all have provided has made that possible, particularly
through the Cures Acceleration Network, which is part of NCATS.
ALZHEIMER'S DISEASE RESEARCH
Senator Moran. Can one of the directors talk about the
improved science this additional investment in Alzheimer's
research will help fund, including a better understanding of
risks and protective factors in individuals, again perhaps with
a focus on rural populations?
Dr. Collins. That is probably me because Dr. Hodes is not
here. So, yes, this committee, this Congress, has increased
funding for Alzheimer's research by five-fold over the course
of the last 7 or 8 years, and that has made possible all kinds
of bold approaches we otherwise would not have had.
We now have dozens of new drug targets that have emerged
from the very careful analysis of who gets Alzheimer's and who
does not. Of course, we are all waiting to see what happens
maybe next month when FDA makes a review decision about the
monoclonal antibody from Biogen, Aducanumab, and that will make
a big difference if they decide there is something there. But,
we are not depending on that.
So, yes, I might add, this ARPA-H proposal, which is part
of the President's budget, specifically calls out Alzheimer's
as an area of great opportunity to do some of these very bold,
aggressive, and nimble approaches that would probably not
happen so easily by our standard grant mechanism.
Senator Moran. Dr. Collins, I was confused by what I
thought was all the directors were appearing, although just not
all of them in person. But, thank you. You can pinch-hit for
each and every one of them and you did it----
Dr. Collins. I will try.
Senator Moran [continuing]. This morning. I am going to see
if I can get Dr. Sharpless to come to Kansas and join us again
on a visit.
Dr. Collins. Well, he is listening, so he heard you.
Dr. Sharpless. Oh, I look forward to that.
Senator Moran. All right. Consider yourself invited, and I
consider you just accepted.
[Laughter]:
Senator Murray. Thank you. Senator Schatz.
Senator Schatz. Thank you, Chair Murray and Ranking Member.
PSYCHEDELIC DRUG THERAPIES
Dr. Collins, in 2019, I wrote to you and the then-FDA
commissioner requesting an update on efforts by NIH and FDA to
research psychedelic drugs to treat mental health illnesses.
Since then, there have been a number of potentially promising,
peer-reviewed clinical research on this topic. Can you give me
an update on what the next steps may be?
Dr. Collins. I appreciate the question. Yes, there has been
a resurgence, I think, of interest in psychedelic drugs, which
for a while were sort of considered like not an area that
researchers legitimately ought to go after. And I think as we
have learned more about how the brain works, we have begun to
realize that these are potential tools for research purposes
and might be clinically beneficial.
I will just mention one, which is Psilocybin, which has now
been tried in no less than three randomized, controlled trials
for depression, and is showing a signal there of potential
interest, and that could be quite exciting because we are
looking for new approaches to that.
But, there are other trials going on with MDMA, even with
Psilocybin--with LSD. I think at the moment, it is the
Psilocybin that has gotten the greatest attention.
Senator Schatz. And what are your next steps?
Dr. Collins. I have been talking with the Drug Abuse
Institute--and I am sorry they are not here--and the Mental
Health Institute--and they are not here, so I am pinch-hitting
for them, as well--about whether it is a good moment to
consider having perhaps a workshop to say, okay, what have we
learned so far, and what more might we want to do as far as
designing the next generation of clinical trials, to see where
these provide benefit going beyond depression to such things as
PTSD (Post-Traumatic Stress Disorder).
So, I think over the course of the next year, we are going
to want to have a hard look at this.
MARIJUANA RESEARCH
Senator Schatz. Thank you. In 2019, you wrote to me that
the NIH is committed to advancing research on the risks and
potential benefits of marijuana for therapeutic uses. In that
letter, you cited a number of barriers to advancing this type
of research. Are we making any progress?
Dr. Collins. We are making some progress. You may know
that, in the past, researchers who wanted to do a clinical
study on marijuana had all kinds of limitations. It took
generally at least a year to get through the process of
paperwork to be allowed to utilize marijuana because it is a
Schedule 1 agent.
But, it was also an issue that there was only one source,
which was our marijuana farm in Mississippi. When I became NIH
director, I was told, hey, you are running a marijuana farm.
Who knew? And that, of course, is an issue because it is a
limited opportunity for access. DEA (Drug Enforcement
Administration) has now given permission to expand the number
of suppliers. That will help.
But, frankly, what we really need is to moderate the
Schedule 1 limitation. Dr. Volkow and I have been proposing for
a while something called Schedule 1-R, which would be basically
a different pathway if you are going to use this material for
research.
Senator Schatz. So, I have a bill with Senators Feinstein
and Grassley, which passed the Senate, did not pass the House,
to address some of these barriers. Do I have your commitment to
work with my office on this legislation?
Dr. Collins. I would be glad to.
NON-OPIOID ALTERNATIVES TO CHRONIC PAIN
Senator Schatz. Thank you. I want to talk to you finally
about chronic pain and non-opioid alternatives. I passed a
couple of laws in this area to enable research. And I think
when people think about alternatives to opioids, they move
right to--in their mind, they move right into alternative
medicine. And, what I am talking about is a non-opioid,
pharmaceutical solution to chronic pain, and I am wondering
whether we are making progress in that space.
Because, certainly, if people find other ways to alleviate
their pain--physical therapy, yoga, whatever, mindfulness--I am
for all of it. But, there is still a space here for a pill that
you can take to alleviate chronic pain without getting you
hooked on an opioid. Where are we with this?
Dr. Collins. That is a critical issue, and this Congress
has supported NIH in something we call the HEAL Initiative,
which is--stands for Helping End Addiction Long Term. Part of
that is about how to better treat people who are addicted to
opioids, but a big part of it is coming up with alternatives
for chronic pain management that are not addictive, that are
not opioids.
As a result of that, we have partnered up with industry to
basically identify promising therapeutics that attack different
targets in the pain mechanism that might, therefore, be
beneficial. Such things as a sodium channel, for instance,
called Nav1.7, that is involved in the pain transmission. But,
if you block that, it should not give you any risk of
addiction. We are making real progress there.
We have something called EPPIC-Net, which is bringing
onboard promising compounds, getting them into Phase 2 trials
as part of the HEAL Initiative. I could give you a lot more
information about that if you would like.
Senator Schatz. Thank you. And I will just submit this one
that you can consider for the record.
The U.S. has the same Federal trust responsibility for
native Hawaiians as it applies to Alaska natives and American
Indians, and I am hoping that you will consider expanding the
scope of the Tribal Health Research Office to include native
Hawaiians. I will get you a more full question for the record
and look forward to your response. Thank you.
Dr. Collins. Glad to look at that.
Senator Murray. Thank you. Senator Hyde-Smith.
Senator Hyde-Smith. Thank you, Madam Chairman. Thank you
for holding the hearing, and thanks to all the witnesses who
are participating today, and I certainly appreciate your
willingness to serve. That is not lost here, for sure, with the
past year that we have had.
FIREARMS RESEARCH AND FIREARM REGISTRIES
Dr. Collins, I wrote to you last November to express my
concerns that projects recently funded by NIH disregard the
spirit, long-established policies against creation of a Federal
firearms registry. And particularly, an NIH grant to Northwell
Health of New York provided Federal funds for the hospital to
ask the questions about lawful gun ownership of every patient
seeking healthcare for any reason whatsoever at the hospital's
emergency department.
Even more concerning, every member of the advisory
committee overseeing the grant has been a very outspoken
advocate for expansive gun control, including bans on large
classes of common and popular firearms.
I have long been concerned about how firearm registries can
undermine the ability of law-abiding citizens to exercise their
Second Amendment rights. Several provisions of Federal law
already prohibit data collection related to lawful gun
ownership, and I have introduced legislation to strengthen
these provisions even further.
Dr. Collins, given that President Biden is seeking
increased funding for grants like the one awarded to Northwell,
how are you making sure that such projects do not infringe on
Americans' constitutional gun rights or violate Federal
statutory prohibitions on gun registries as they stand right
now?
Dr. Collins. Senator, I recall your letter, and we looked
closely at that particular grant from Northwell and what they
were proposing to do.
First of all, I think we can all agree that gun violence,
which takes about 40,000 lives every year, is something that
does deserve close attention and scrutiny as far as the
research that we might be able to do to understand what are the
causes and how to save those lives if it is possible to do so.
So, we will actually be glad to pursue those opportunities.
But, we are mindful of the prohibition that Congress has
put forward many years ago about not advocating for gun
control, and we have been pretty careful about that. I think in
that instance, the particular grant, while you are right that
they were asking for this information, it fell somewhat short
of what most people would have called a broad concept of a gun
registry. And I think that is, if I remember, what we said in
the letter in response to you.
But, I want to promise you, we are going to be very
sensitive to those issues, as we now, with the President's
budget, seek to see if we can do more to try to identify
reasons that gun violence is so prominent and what research
might teach us about how to save lives.
Senator Hyde-Smith. Thank you. I appreciate your
consciousness of that.
ORIGIN OF COVID-19
And this question may have been asked before. I have been
in another hearing. I hope I am not being redundant. But, like
many of my colleagues, I firmly believe we need to get to the
bottom of the origin of COVID-19, and this seems even more
important after this week's Wall Street Journal report that
three researchers from China's Wuhan Institute of Virology
sought hospital care in November 2019--for symptoms consistent
with COVID-19.
First, I want to go down the line for all of our witnesses
of how strongly do you believe that it is possible that the
origin of the COVID-19 pandemic resulted from a leak of the
virus from the Chinese lab?
And second, Dr. Fauci, I would like to ask you
specifically, how is your institute working to get to the
bottom of the origins of COVID-19, including exploring the
laboratory leak theory?
So, I am going to start with the entire panel for the first
question of, how strongly do you believe that this is possible?
Dr. Collins. Well, I will start, and then others can
respond. Again, I will say, I think the most likely reason,
mechanism, by which SARS-CoV-2 arose was a natural process of
transfer from an animal to humans, but it is certainly possible
that other options might have occurred, including a possible
lab leak. We just do not have evidence to be able to say what
that likelihood is.
Dr. Bianchi.
Dr. Bianchi. Yes. So, I would agree with Dr. Collins. We
have no personal knowledge of anything that might have happened
in China at the National Institute of Child Health and Human
Development, but we fully support a full investigation of
getting at the facts.
Dr. Collins. Dr. Gibbons. Dr. Gibbons, are you there?
Dr. Gibbons. Yes. I concur with my colleagues in terms of
transparency is a critical part of this.
Dr. Collins. Dr. Sharpless, I think I saw you on the
screen.
Dr. Sharpless. Sure. Yes, Senator Hyde-Smith, I saw the
same report and I found that concerning. I think lab accidents
happen and we need to investigate the possibility. Although I
think many of us feel zoonotic transfer is perhaps more likely,
I think we should investigate all possible explanations.
Dr. Collins. Dr. Perez-Stable.
Dr. Perez-Stable. I concur with my colleagues. I think of
concern, but certainly we need evidence.
Dr. Collins. And Dr. Tromberg.
Dr. Tromberg. Yes, I agree with my colleagues, as well, and
would like to see more investigation.
Dr. Collins. Dr. Fauci.
Dr. Fauci. Yes. As I have said many times, I feel the
likelihood is still high that this is a natural occurrence.
But, since we cannot know 100 percent whether it is or is not,
other possibilities exist and, for that reason, I and my
colleagues have been saying that we are very much in favor of a
further investigation to the next phase from the WHO, who has
already done a phase one. And, we are strongly in support of
continuing that to a phase two investigation.
Senator Hyde-Smith. Thank you----
Senator Murray. Thank you.
Senator Hyde-Smith [continuing]. Very much, and I yield my
time.
Senator Murray. Thank you so much. Senator Baldwin.
Senator Baldwin. Thank you, Madam Chair.
Last week, I had the privilege of joining some of my
colleagues on a visit to the National Institutes of Health.
While much of our discussion was centered on the response to
the COVID-19 pandemic, I was struck by the broad applications
of the innovation that we have seen during this time.
ADVANCES IN VACCINE AND THERAPEUTIC DELIVERY SYSTEMS
(RADX PROGRAM)
And, I have often spoken about the Wisconsin-based company,
FluGen, which is working to make vaccines that can be
administered as a nasal spray. I also believe that this type of
innovation is key in terms of how we think about our ability to
respond to future pandemics.
Dr. Tromberg, it was great to see you on that trip to NIH.
I wonder if you could describe how engineering advancements
have contributed to our response to COVID-19. And, how are you
thinking about the future of delivery and administration of
vaccines and therapeutics? And, how will these advancements
help us prepare for the future?
Dr. Tromberg. Thank you, Senator Baldwin, for the question,
and it was great to meet you last week, or I guess it was 2
weeks ago when you came to visit.
So, for COVID, we have supported a wide range of
technologic advances in medical imaging and artificial
intelligence, digital health platforms, PPE (Personal
Protective Equipment), ventilators, new therapeutic approaches.
Of course, the biggest probably and most impactful has been the
RADx testing program, which has delivered, as you have seen,
more than 300 million tests, including over-the-counter tests
with very advanced technologies from nanoscience.
In terms of vaccines, this is a very exciting area. Another
one that we have had in our portfolio, one of the strategies
that we have been supporting, are micro needle patches. So,
imagine a dime-sized micro needle patch that has got--the
needles are entirely soluble in water, and as soon as you put
them into your skin, they start to deliver the vaccine. After
the delivery, the needles are all gone, and you throw the patch
away. You get a new one in the mail. So, this has moved into
Phase 1 clinical trials. Efficacy has been shown.
I might, if you have a moment, toss it over to Dr. Fauci
because we have collaborated with his institute in the
development of these new delivery approaches and they may have
some other approaches, as well.
Senator Baldwin. Please. Dr. Fauci.
Dr. Fauci. Thank you, Bruce. Yes. We have an active
collaboration with Dr. Tromberg's Institute and we are looking
towards the future about how we can make it much easier to get
people vaccinated. This is of particular relevance right now
because, with COVID-19, even though we are doing really very
well with vaccination, we still have a group of individuals who
were really difficult to get to. And hopefully, when we have a
much easier way to administer the way Dr. Tromberg has
mentioned, that will make it easier for us.
Senator Baldwin. Excellent. In April, the University of
Wisconsin launched the Center for Health Disparities Research
Center, which has a leadership team comprised entirely of
women, will focus on how physical environment and social
conditions intersect to influence an individual's health.
Their first initiative, funded by the NIH, will use data
from 22 Alzheimer's disease research centers throughout the
U.S. to examine how social determinants of health throughout a
person's lifetime impact their brain health.
The pandemic has made it clear that we need to do more
research like this to better understand and respond to health
inequities, and I applaud the work of Dr. Amy Kind and the
University of Wisconsin. It is imperative that we maintain our
commitment to this into the future.
COVID-19 AND HEALTH DISPARITIES
So, Dr. Perez-Stable, how has the impact of the COVID-19
pandemic on communities of color informed how NIH thinks about
studying health disparities going forward? And what additional
investments are needed to fill these gaps?
Dr. Perez-Stable. Thank you, Senator Baldwin, for that
question. I think a year ago, when we understood the dimension
of the dramatic, disproportionate burden by race, ethnicity,
and socioeconomic status on the population, there was sort of
an aha moment for all of NIH to say, this problem has been with
us for a long time. We have made limited progress. It is time
we put our innovation, our efforts, to address this.
Out of this effort, we created the Community Engagement
Alliance Against COVID-19. Dr. Gibbons and I are co-chairing
that. Dr. Collins mentioned it in his opening statement. And I
think to heighten the importance of community engagement, so
talk to the people that are affected, bring them in as full
partners, identify the problems, and then mobilize all sectors
that we can mobilize. Not just the researchers and the
healthcare clinicians, but also the housing, transportation,
zoning, all the different sectors of society, to see how we can
begin to make a difference in this setting.
And I applaud the effort of Dr. Kind. She was a grantee of
ours, as well as others, and also applaud the effort of looking
at existing data with standardized measures to address problems
of this kind, like Alzheimer's disease.
Senator Baldwin. Yes. Thank you so much.
Madam Chair, I yield back.
Senator Murray. Thank you. Senator Rubio.
Senator Rubio. Thanks, all of you, for being here.
I think I will direct this to Dr. Fauci, but I welcome
everybody's answer. I just want to go through, so, what we do
know. We have heard a lot about what we do not know.
So, here are the things that we do know, okay?
ORIGIN OF COVID-19
So, SARS-1, we identified the host animal within 4 months.
MERS, I believe, we identified the host animal within 9
months.
It has now been 15 and a half, 16 months, we have still not
seen and China has not produced any evidence of the host animal
that transmitted COVID-19 to a human.
We know that China has a history of lab accidents. I think,
Dr. Fauci, you answered Senator Graham's question. I think he
phrased it as, has there ever been a pandemic that came out of
a laboratory, and the answer was no.
But, we know of outbreaks that came out of a laboratory. I
believe back in 2004, two researchers in Beijing were infected
doing research on SARS and it led to an outbreak. China has a
history of lab accidents.
This outbreak happened in a city that happened to be the
home, coincidentally, of a lab which we know is involved in
extensive research. And, what they do is they take this
naturally-occurring virus and they manipulate it and they
change it to make it infectious to humans. We know that they do
that there. They have published about it.
And, it also happened in a city in a lab where a Rutgers
biosecurity expert raised concerns about its safety, and our
diplomats in 2018 were cabling back to Washington expressing
concern about the safety.
So, I take all those facts together, right?
SARS, we knew the host in 4 months.
MERS we knew the host in 9.
We still do not know the host in--for COVID, even though--
and China is not being transparent about it even though they
have a vested interest in producing the host so they can put
all this down.
In a lab that we know is involved in changing viruses
synthetically so that they become infectious for humans.
In a lab that diplomats have told us is unsafe.
In a country that had history of lab leaks.
And, by the way, in a virus that we know can be
synthetically-created because the Swiss did it. The Swiss
created an exact replica of this virus in the lab for purposes
of answering it.
All of these facts were available to us last May, last
April. Why--I will start with Dr. Fauci. Why did you dismiss
the lab leak theory as credible?
Dr. Fauci. I have always said that the high likelihood is
that this is a natural occurrence. I did not dismiss anything.
I just said it is a high likelihood that this is a natural
occurrence from the environment of an animal reservoir that we
have not yet identified, and I still maintain that.
But, as I just mentioned in response to other questions,
that since you do not know 100 percent about that, because no
one knows, including me, 100 percent what the origin is, is the
reason why we are in favor of further investigation.
Senator Rubio. Well, given everything I have just cited--
and if anything I just cited is incorrect, I hope I will be
corrected. I am relying--obviously, not my field of study, so I
am relying on what other experts have published. What is the
basis for this high likely--what is the basis for the
conclusion that it is likelier to have been naturally occurring
than a lab accident?
I asked a specific question to the Director of National
Intelligence, and how I posed it is, is it not true that it is
the assessment that they are equally likely, based on our
information that we have.
So, as I outline all of these things here, is she wrong
when she answered me yes? And, based on everything I have just
cited, why the--what is it that we are basing the higher
likelihood of naturally occurring? Is it simply because that is
all we have ever seen in the past?
Dr. Fauci. Well, we have historical experience that
happened with SARS-CoV-1. It happened with MERS. It happened
with HIV. It happened with virtually all the influenza
pandemics. So, the historical basis for pandemics evolving
naturally from an animal reservoir is extremely strong, and it
is for that reason that we felt that something similar like
this has a much higher likelihood.
But, again, getting back to what I said--and let me repeat
so there is no lack of clarity in that. No one knows, not even
I, 100 percent at this point, which is the reason why we are in
favor of further investigation.
Senator Rubio. But, going back to precedent, precedents
require them to be similar. The difference between this one and
that one is--as I said, 4 months we knew the host for SARS, at
9 months we knew the host for MERS. China has all the incentive
in the world to produce this host and has not done so. And,
then, you add up all these other things, I mean, is it just a
coincidence it happened in the city that is doing this kind of
research, which, by the way, is controversial? I know you and
others have been supportive of it, but it is controversial. It
is not widely accepted as good.
My whole point is there are people out there who had
Facebook posts taken down. They are called kooks, conspiracy
theorists, for saying publically a year ago what we now say may
be possible. I think those people deserve an apology, at a
minimum.
Thank you.
Senator Murray. Thank you.
COVID-19 AND MIS-C
Dr. Bianchi, thank you. NICHD (National Institute of Child
Health and Human Development) is trying to develop ways to
identify children at high risk for multi-system inflammatory
syndrome in children. It is a rare and life-threatening after
effect of COVID-19. Now, while most children who become
infected, I know, have mild or no symptoms, some do go on to
develop this severe and sometimes fatal condition. I know your
research is still in the early stages, but could you describe
the NICHD's efforts to develop clinical, predictive models
using machine learning to identify children at risk and how
physicians are using this testing device and data?
Dr. Bianchi. Thank you very much for your question, Senator
Murray. As you know, there are almost four million children who
have been infected with SARS-CoV-2, but the key is to figure
out which is the one-in-a-thousand child who is going to get
very sick with this MIS-C, and that child could get critically
ill, although most do recover. So, as a parent, you would want
to know if my child tests positive, what is going to happen.
And, so, as part of the RADx RAD program--NIH is supporting
this. It is four different programs CARING for Children with
COVID, but the predictive one that is using artificial
intelligence and machine learning is called the PreVAIL Kids
Program. And what that is, is it is eight different programs
around the Country, with some international partners, that are
using existing cohorts, as well as prospectively enrolled
cohorts, to collect biospecimens and use artificial
intelligence in conjunction with the electronic health records.
The program started within the past few months, so we do
not have evidence yet. But, the enrollments are on target, and
we are expecting to enroll about 12,000--actually, we have
already enrolled about 12,000 children out of 16,000 that are
expected.
A.I. DETECTION OF CANCERS
Senator Murray. Okay. And Dr. Sharpless, artificial
intelligence has been shown to help improve the detection of
breast cancer in mammograms, and lung cancer in CT scans. And
suggesting that AI appears well suited for imaging, are you
looking at the potential for AI to help early detection of
other cancers?
Dr. Sharpless. Oh, yes. This is a very important topic. I
think artificial intelligence has really the ability to
transform cancer research and cancer clinical care in dramatic
ways.
We have a very lively set of collaborations going on with
the Department of Energy that has extensive expertise in this
topic. To use, you know, AI to try and identify drug targets
for medicinal chemistry, or to use AI to read 600,000 pathology
reports that we get for the SEER database every year, or to use
artificial intelligence for image analysis, both pathology
images and radiology images.
So, I think this is a tremendously exciting technology that
has real opportunities to advance cancer research and cancer
care in many important ways.
I think we were also worried about the ethical issues of
AI, and we want to make sure that we use practices that will
not reinforce biases that are latent in some of our data sets.
But, overall, I think the promise of AI is very exciting
for cancer research.
Senator Murray. Interesting. Okay.
CLIMATE CHANGE AND HEALTH
Dr. Gibbons, the request, budget request, includes $110
million to study the impact climate change is having on health.
Talk to us about what kind of serious effects have we been
seeing from climate change, and what kinds of research do you
expect NHLBI (National Heart, Lung, and Blood Institute) to
support with this kind of funding?
Dr. Gibbons. Yes. Thank you for that question. As we know,
climate change often involves these changes in our air, in our
air quality, particularly it is likely to promote more air
pollution. Certainly, the constituents on the West Coast are
familiar with the impact of wild fires on air quality.
And although air is all around us, air pollution tends to
concentrate and have its greatest impact on certain
communities, particularly communities in which those
neighborhoods are closer to sources of air pollution, and
therefore, the impact is also inequitable in terms of the
health consequences of air pollution, and that is falling on
the most vulnerable.
We know that it exacerbates certain chronic conditions,
certainly cardiopulmonary ones like chronic obstructive
pulmonary disease, asthma, heart failure. Heart attacks are
increased in the context of higher air pollution promoted by
climate change.
And, we anticipate that there will be a need to not only
mitigate the impact of climate change, but also to enhance
resilience to the effects of air pollution on health, and we
anticipate that that will involve enhancing healthy communities
that are disproportionately affected by the consequences of air
pollution derived from climate change. And our programs that
are community-engaged research with that health equity lens
should be promising in that regard.
Senator Murray. Okay. I think this is really important, and
I think we all should recognize that this is an area we need to
look at, so I appreciate your work on this and we will be
following it closely.
I will turn to----
SEXUAL HARASSMENT AT NIH
Okay. I have one additional question and that is for Dr.
Collins. In 2018, the National Academies, as you know, released
a report that found that nearly 60 percent of women in academia
have experienced--60 percent--have experienced sexual
harassment on the job and recommended that Federal research
agencies require institutions to notify them when individuals
on grants have violated harassment policies or put on
administrative leave due to harassment allegation. And other
science agencies, like National Science Foundation, have
implemented these changes.
Tell me, what is NIH doing to require its research
institutes to do the same?
Dr. Collins. Senator, I share the sense that this is an
extremely important issue. The National Academy report that you
mentioned I think really got everybody to recognize how
pervasive sexual harassment is and what a significant negative
it has been for far too long for women in our scientific
workforce.
We conducted our own working group in the Advisory
Committee to the Director that reported to me in December of
2019 and made a series of very significant recommendations
about how we might change our approach to this. We have been
working through those and have already implemented a
significant fraction of them. There are some that still require
some additional legal authority that is hard for us to be able
to do at the present time.
In terms of what you are particularly pointing to, we have
had now more than 300 allegations that have been brought to us
about sexual harassment in our grantee institutions; others
within our own intramural program. Of those 300, about 30
percent of them have turned out to be actually entirely
validated. That has resulted in a hundred different changes in
grants that--particularly, removal of principal investigators
and replacement of those with other individuals.
One hundred and twenty-five individuals have been taken out
of our pool of peer reviewers because of this kind of concern
about the bias that they bring to that experience.
And we have made it very clear to our institutions that we
expect them to report any circumstance----
Senator Murray. Well, expecting them does not require them
to.
Dr. Collins. And, Senator, you and I are in an interesting
discussion here that I agree--I wish we were able to simply say
require. At the present time, legally, we are told we do not
have that authority. We would have to go through a 2-year
rulemaking effort, or we would need statutory assistance.
Senator Murray. Well, okay. This is really important, and
whatever we need to do, I do not--you know, I know you have
worked on it, I know you have focused on it, but I know of
women who have left our scientific research institutes because
of this. We cannot afford to have that happen for a thousand
reasons. So, whatever it is we need to do here, we need to know
what it is so we can do it.
Dr. Collins. I am so with you. And if there is another
iteration we can take at this to try to figure out--I will say
that what we have said in terms of the expecting response from
our institutions has gotten their attention in a pretty
remarkable way. Even without requiring it, we are seeing
reporting coming through.
Senator Murray. Well, to every one of them that is
listening, I am not done with this.
Dr. Collins. Okay.
Senator Murray. Senator Blunt.
Senator Blunt. Thank you, Chair.
I have three or four questions. Let me eliminate a couple
of other topics by just making a couple of comments on some
things that have already been said, one, and one thing that has
not been, I do not believe, brought up today.
One is on the CTSA awards. None of the people talking to us
that are current recipients think that this simplifying the
process makes it more likely that they will get the research
bench-to-bedside result that they think you want and they think
is the key to this award.
And, you have heard a number of schools mentioned, and
University of Washington would be one of them that Senator
Murray would be very familiar with. Washington University in
St. Louis collaborates through this program with Saint Louis
University and the University of Missouri to get to more rural
hospital settings and do things. So, I suspect you have heard a
number of concerns about that today.
I have not heard brought up one of my concerns, which I am
just going to mention. I do not think you need to respond to
it. I do think that waiving the intellectual property rights on
COVID-19 vaccines is a problem. I think it is a problem because
I do not think it actually would increase the number of
vaccines, the capacity to produce a vaccine that has efficacy,
in the timeframe we need to make it. It probably is not
benefitted much by waiving the rights to the research. The WTO
(World Trade Organization) has to unanimously agree, which I do
not think they do. But, if they do, we give our research to
everybody.
And third, when this comes up again, companies would have
less willingness, I think, to step forward. At least one of the
companies, Dr. Collins that we dealt with in Warp Speed, there
was no agreement at all that if they were not successful--we
had a contract. We would buy 100,000 doses, but only if they
were FDA authorized. So, they were out there totally on their
own, as these companies you would expect to be.
I do not think this is likely to happen because of the WTO,
but I have some concerns that I suspect are shared by others at
NIH.
IMPACT OF COVID-19 PANDEMIC ON CHILDHOOD DEVELOPMENT
Dr. Bianchi, just the title--let's just take the title of
your Institute and look at COVID. What do you think the impact
on child health and development of COVID and the COVID
environment, the pandemic environment, the quarantine
environment, has been? And how are we going to be looking at
what the long-term ramifications of that might be and what
advice we may be able to give to schools and moms and dads and
behavioral health and other health providers as it relates to
child development impacted by this?
Dr. Bianchi. Thank you so much for that question, Senator
Blunt, because children, you know, have not--I think they are
so important in terms of our Nation's future, first of all.
But, the fact that children have been home from school has
affected the entire family, has affected the workforce, et
cetera.
But, because children in general have been asymptomatic or
mildly symptomatic, they have not gotten as much attention, and
yet being at home, being away from in-person schooling, I think
may have significant impact for years to come. And, for that
reason, we are trying to get the kids back to school as soon as
possible.
And as part of the RADx Underserved Population program, we
are also leading an initiative to really develop, evaluate, and
implement testing, along with mitigation, of, you know, hand
washing, social distancing, et cetera, to get evidence to
reassure people to get kids back to school. Two of the sites
are actually in Missouri, and one is in Washington State. There
is a program in Yakima, and there is a special program in
Missouri that is looking at how you deal with kids who have
intellectual disabilities and cannot mitigate in the same way.
So, to answer your question, I think there will be long-
term effects. I think the answer is to get kids back to school
safely, with evidence. And, this program is based on a funded
project that was very successful in North Carolina that showed
with all the mitigation, with the work with the superintendents
of schools, that the secondary infection rate in schools was
extremely low compared to the community.
Senator Blunt. Yes. I would think here that some of the
developmental issues, and they will be different with 4 and 5
year olds and kindergarten and first grade than they will
people in seventh grade, and those may be different than
people----
Dr. Bianchi. Absolutely.
Senator Blunt [continuing]. In the eleventh and twelfth
grade and how--you know, I think we are going to have to watch
this carefully and try to get data and then share that data.
FUTURE OF MRNA TECHNOLOGY
On vaccines--actually, on--maybe more on mRNA than
vaccines, what do we think the impact may be as it relates to
cancer, to HIV? We will start, Dr. Fauci, with you. Can we look
at the flu shot in a different way? And what do we think the
mRNA impact, now that we know this different use for it, may
have on other healthcare settings? And Dr. Sharpless, I am
going to come to you second on this.
Dr. Fauci. It is going to--I believe, and many of my
colleagues believe, that the mRNA technology, as it has been so
spectacularly successful with SARS-CoV-2 to develop a vaccine
against COVID-19, is already being pursued for other
infections, including HIV and including influenza. So, there
are a couple of things that are going on now. Even as we see
the successes with COVID-19 in using the mRNA technology for
the development, for example, of universal flu vaccines, as
well as now having HIV vaccine researchers now looking at the
possibility of an mRNA platform technology to use for HIV. So,
it is already happening.
Senator Blunt. Dr. Sharpless, on mRNA, I mean, we know the
impact in just the last half dozen years of immunotherapy on
cancer treatment. What about this mRNA intervention and how it
might impact the way we look at fighting cancer?
Dr. Sharpless. Yes, this is a very exciting topic. You
know, people interested in this space have been working on
this, you know, long before the pandemic. So, using mRNA for
cancer therapy has many potential applications because you can
really get the body to make a protein, and that protein could
have a desirable effect against cancer, for cancer therapy, in
a lot of ways.
The furthest advance, as you mentioned, is the use of mRNA
vaccines, you know, cancer vaccines. And clearly, they tend to
be highly personalized, the ideas that you can sequence
someone's own tumor and then make the vaccine to their very own
tumor in a way that will not cause them autoimmune side
effects, and this is an idea to augment other kinds of
autoimmune cancer--or anti-immune cancer therapies.
So, it is a very promising area. It is in clinical trials,
and we just need to see how this develops.
Senator Blunt. Thank you. My last question, Chair.
IMPACT OF COVID-19 PANDEMIC ON RESEARCH AND RESEARCHERS
Dr. Collins, in the pandemic, particularly with lab
closings, we obviously lost some time, and lost research that
is going to take a long time to recreate. Are the lab
reopenings happening in the way they need to? And, do you have
the flexibility to extend a grant to overcome the disruption?
And probably just not this disruption of the time closed, but
the research lost by closing, as well.
Dr. Collins. I am glad you are asking because this is yet
another of the terrible casualties of this terrible pandemic.
It has been very hard on researchers, especially those who need
a laboratory to do their work or who were running a clinical
trial that was very hard to enroll participants. And, yes, we
did have to have many of those folks staying away from the
workplace for their own safety.
They are coming back. Our own program at NIH, our
intramural program, now is up to about 50 percent occupancy,
but it is not anywhere near where it was pre-pandemic. We have
done everything we can with our flexibilities to try to make
sure, particularly, that trainees and early-stage investigators
do not get further injured by this by extending the periods of
their training; or by allowing grants if they are able to put
forward a special request to be extended for an extra year,
either without extra funds, or with, if the case is strong.
And yes, I also think we need to be cognizant of the way in
which this is affecting people in other ways. We have now come
up with a way to provide childcare support for our trainees who
otherwise have not had that, and that has been one additional
burden on their shoulders.
Our estimates are that it is about a $16 billion loss that
has occurred because of the way in which this has affected
research in our extramural institutions; that they are in a
tough place to try to make up. So, I appreciate your asking the
question.
We are going to have a really big challenge getting
ourselves back into the place that we were before this
happened.
Senator Blunt. Well, let us know what we need to be
thinking about as we think about the rest of this bill on that
topic. And thank you, Chair.
Senator Murray. Thank you very much. And I want to thank
all of our witnesses today for their really--for a really
productive hearing. I think we all learned a lot. So, thank you
very much.
ADDITIONAL COMMITTEE QUESTIONS
For any Senators who wish to ask additional questions,
questions for the record will be due one week after the
President's budget is delivered at 5 p.m. The hearing record
will also remain open until then for members who wish to submit
additional materials for the record.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted to Dr. Francis Collins
Questions Submitted by Senator Patty Murray
Question. The President's fiscal year 2022 skinny budget proposed a
major new biomedical research effort by establishing ARPA-H. While the
skinny budget was light on details regarding the structure of the
program, the Administration's statement indicated that the initial
focus of ARPA-H would be `on cancer and other diseases such as diabetes
and Alzheimer's.'
Assuming Congress and the Administration work together to establish
ARPA-H, how would you envision ARPA-H setting priorities for research
into additional diseases?
Answer. Over the long term, the proposed structure for the Advanced
Research Projects Agency for Health (ARPA-H) is intended to empower the
ARPA-H leadership and staff to set and execute on research priorities
for a variety of high-risk, high-reward, milestone-driven projects that
can lead to novel capabilities, platforms, and resources that are
applicable to a range of diseases.
For the initial direction, the Administration is working to set up
multiple pathways, both within the government and the broader
stakeholder community, for priority setting and for exploring new areas
ripe for research at ARPA-H. At the time of this hearing, the White
House Office of Science and Technology Policy (OSTP) and the National
Institutes of Health (NIH) are in the planning phases of convening
multiple listening sessions with key stakeholder groups including
patient organizations, industry, venture capitalists and
philanthropists, and others from the academic and research communities.
During these sessions, stakeholders will be asked to offer their
perspective on what they see as the greatest research challenges and
opportunities that could be addressed using the ARPA-H model. This
input will help refine the scope and provide a wealth of ideas for the
first ARPA-H director to consider as they develop the agency's vision.
In mid-July, the Administration established a Joint Fast Track
Action Committee (FTAC) to help steer the creation of ARPA-H and lay
the groundwork for strong interagency coordination. OSTP and NIH serve
as co-chairs of this committee that includes representatives from
Department of Agriculture, DARPA, Office of the Under Secretary of
Defense for Research & Engineering, ARPA-E, BARDA, CDC, CMS, FDA, VA,
EPA, NSF, and the Smithsonian Institution, among others.
Question. Some of the greatest advances in medical innovation in
the last decade have been brought on through genetic analyses and use
of sophisticated computer programs that can shorten the time taking
drug candidates through clinical studies. In fact, the development of
COVID-19 vaccines benefited from the use of 21st century technology
like cloud computing and AI to help stop the virus' spread and save
lives.
How will the President's budget build on the use of modern tools
like cloud computing, AI, and genetic analyses to further accelerate
the delivery of cures to patients?
Answer. Over the last decade, pharmacogenetics has advanced the
frontier of personalized medicine such that drug therapeutics are
developed based on the genetic aberrations of disease. This approach is
most notably applied for cancer treatments and also other diseases.
Cancers of various types are treated by first knowing the genetic
mutations and/or deletion of genes. Then drug candidates are screened
and developed by computer modeling of the target sites along with
potential drug candidates. Such modeling requires various large
datasets and analytics that, if stored in the cloud and interoperable,
can be mined to find the best drug candidates that bind to the target
sites for treatment. Storing large datasets in the cloud is only the
first requirement for cloud computing. Such computation requires new
tools, and support for tool development is essential to realize the
opportunities for cloud computing.
Artificial intelligence (AI) has advanced the pace of drug
discovery and development via predictive models of drug/target
interactions and also facilitates clinical trial design based on
algorithms for go/no go decisions during the trials.
The President's Budget Request supports the application of AI to
improve diagnostics for diseases as diverse as coronavirus disease 2019
(COVID-19) and cancer. In each case, information-rich data sources that
are stored, aggregated together, and analyzed in the cloud are used to
rapidly train and test these new capabilities. New programs like the
Artificial Intelligence/Machine Learning Consortium to Advance Health
Equity and Researcher Diversity program, or AIM-AHEAD, and Bridge2AI
will harness AI for health by generating AI-ready datasets and best
practices for machine learning. This will allow researchers to
accelerate data-driven discovery for grand challenges in biomedicine
using AI-based technologies. Additionally, NIH's partnership with cloud
services providers--Google, AWS and now Microsoft Azure--further
enhances researchers' abilities to leverage industry technologies and
utilize AI-ready data for drug discoveries and therapeutic treatments.
______
Questions Submitted by Senator Richard J. Durbin
Question. I have worked with the Subcommittee Chair and Ranking
Member for years on sustained, predictable increases to the NIH
budget--with the goal of providing at least 5 percent real growth year-
over-year. We have had success, leading to a 42 percent increase over
the past 6 years, along with supplemental funding in COVID-19 relief
packages. The President's fiscal year 22 budget calls for a 19 percent
increase to the NIH overall budget. The vast majority of that comes
from the proposed creation of a new advanced research effort, called
ARPA-H. When I toured the NIH campus recently with many members of this
Subcommittee, you discussed how innovative efforts during the
pandemic--such as with the RADx testing program or Warp Speed vaccine
development--align with the ARPA-H proposal, incorporation closer
partnerships with industry and coordination at different stages in the
research and development of promising breakthroughs. Your testimony
discusses application of this nimble ARPA-H proposal for cancer,
infectious diseases, and autoimmune diseases.
As we evaluate this proposal, what are the core aspects of this
ARPA-H policy that you want us to keep in mind?
Answer. We envision that the Advanced Research Projects Agency for
Health (ARPA-H) will be able to tackle large-scale challenges using a
proven high-risk, high-reward approach that embraces nimbleness and
flexibility with the broader goal of delivering rapid breakthroughs
that serve all patients. Being successful in this endeavor requires
close communication and collaboration across government and with key
stakeholders in the external biomedical community. This could include
undertaking projects with Federal agencies, private companies,
independent research institutes, medical centers, as well as academic
institutions--all collaborating to advance innovative health research.
NIH deployed similar approaches in response to the COVID-19 pandemic
(Accelerating COVID-19 Therapeutic Interventions and Vaccines, or ACTIV
and Rapid Acceleration of Diagnostics, or RADx)--which yielded life-
saving results for Americans, and also served as a learning opportunity
to appreciate further the value of employing a DARPA--like model to
support research. With Congressional support, we believe we can
leverage these models in other areas of health research to drive
transformative change and impact.
Question. We have spoken in the past about two seemingly divergent
issues. On one hand, we talk about the need to invest in medical
research to find breakthroughs and cures for patients, so we rightfully
appropriate billions into NIH-funded research--sign me up for that. But
then these drugs come to market--the vast majority of them benefitting
from NIH research (e.g. a study finding that all 210 drugs approved by
FDA between 2010 and 2016 benefitted from NIH-funded research in some
form)--and too many of them with exorbitant price tags. Recent studies
show that high costs contribute to poor medication adherence, including
with one-quarter of cancer patients choosing not to fill a prescription
due to cost. I know Dr. Sharpless has talked about the ``financial
toxicity'' for cancer patients. Americans pay the highest prices for
medications in the world, with a recent GAO report finding that the
U.S. pays two- to four-times more for certain medications than other
developed countries. It is counterintuitive and an outrage that
taxpayers fund cutting-edge research, which leads to drugs, that we
often cannot afford once they hit the market. I understand NIH does not
set drug prices and does not want to limit the handoff or development
of its research to stakeholders that commercialize the discoveries. But
the current system does not maximize the benefits for patients.
Given the role of NIH research in contributing to FDA-approved
medications, many of which come with extremely high price tags, what
specific steps can NIH take to ensure that patients are able to afford
the incredible discoveries made at NIH?
The NIH has received several petitions to exercise march-in rights
(35 U.S.C. Sec. 203), but has never done so.
--Under what circumstances would NIH consider doing so?
--Under that statutory authority, how does NIH define and evaluate
the term ``practical application'' for the purposes of how a
contractor or assignee makes a subject invention funded by NIH
available to the public on reasonable terms?
--What are the factors used in such definition and evaluation?
--Can you provide an example of the analysis undertaken in evaluation
of a previously filed march-in-petition?
Answer. The National Institutes of Health (NIH) shares your concern
about the high price of drugs and the impact on public health. The
article you reference shows that all of the 210 drugs approved by U.S.
Food and Drug Administration from 2010 to 2016 were based on at least
one scientific publication reporting on research funded by the NIH.\1\
The researchers reported that 96 percent of the NIH funded projects
were identified based on a search for the ``target'' rather than the
drug itself. Identifying a drug target, meaning a protein in a cell
that has a function in a disease process, opens the door for any
researcher in industry or academia to screen for drugs that bind to the
target to slow or arrest disease processes. This research is key to a
vibrant drug discovery process in the United States and does not limit
discovery to one drug for each target. The development of multiple
drugs for a particular disease allows the patient and physician to
choose the best one for them and can lead to price competition in the
market. Drug pricing is a complex problem that involves various
segments of the market, much of which NIH has no control over. A
smaller number of important drugs utilize patented inventions funded by
the NIH. When NIH has been asked to consider march-in under the Bayh-
Dole Act based on the price of such drugs, NIH has stated that the
issue of drug pricing is one that should be address by Congress, as it
considers these matters in a larger context.\2\
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\1\ Cleary et al., 2018, www.ncbi.nlm.nih.gov/pmc/articles/
PMC5878010/.
\2\ NIH march-in responses from 1997-2013 at ott.nih.gov/policy/
policies-reports under ``NIH March-In Response''.
---------------------------------------------------------------------------
The Bayh-Dole march-in provision (See 35 U.S.C. 203) allows a
government funding agency to require a grantee to grant a license to a
patent of an invention made under that agency's awarded grants or
contracts and allows other ``responsible applicants'' to obtain the
license if one of four circumstances are met:
1. the contractor or assignee has not taken, or is not expected to
take within a reasonable time, effective steps to achieve practical
application of the subject invention in such field of use
2. to alleviate health or safety needs which are not reasonably
satisfied by the contractor, assignee, or their licensees
3. to meet requirements for public use specified by Federal
regulations and such requirements are not reasonably satisfied by the
contractor, assignee, or licensees
4. the agreement required by section 204 [a requirement that
patented products be manufactured substantially in the United States
unless a waiver is granted]
The first two criteria are typically cited in petitions to consider
a march-in by the National Institutes of Health (NIH). For example, if
a company has rights to a government funded patent for a drug candidate
but is not making reasonable efforts to bring it to market, the company
may be failing to meet the requirements to achieve practical
application of the invention. These criteria are considered on a case-
by-case basis by the agency in view of the facts presented in each
case.
If NIH were to march-in, the grantee could appeal that decision
through the Federal courts. Only after the company had lost all legal
appeals could NIH grant a license to a second company, should there be
one interested in developing a new version. Additionally, the drug
could be covered by other patents that cover certain aspects of the
drug, such as methods of making and administering it. In such
instances, the march-in could be ineffective, because the original
company could stop a new company from making the generic until the
other patents expire.
After the court appeals and expiration of any other patents, a
company would typically have to conduct clinical trials or otherwise
establish equivalency with the brand drug to obtain U.S. Food and Drug
Administration approval. The entire process, including administrative
hearings, court appeals and new clinical trials, could take years
before the new product reached the market. In the meantime, alternative
therapies may have become available or the patent subject to march-in
may have expired.
NIH has considered march-in on several occasions and was either
able to work with parties to reach an agreement to address the issues
raised, such as the case with CellPro and Fabrazyme, or decided that
the march-in legal requirements were not met to march-in to address the
public health and safety issues raised, such as was the case with
Norvir.\3\
---------------------------------------------------------------------------
\3\ See ott.nih.gov/policy/policies-reports under NIH March-In
Response.
---------------------------------------------------------------------------
Question. The COVID-19 pandemic has impacted every major sector of
the economy of the United States, including our nation's biomedical
research. I have heard from countless universities across the state of
Illinois about the impact that this pandemic has had on the medical
research pipeline. From shuttered labs, to interrupted or delayed
clinical trials, to unforeseen pandemic-related costs, they have
estimated that this pandemic has caused over $10 billion in lost
research. Last year, Senator Moran and I sent a bipartisan letter to
Senate leadership, requesting at least $10 billion in additional
funding to help make-up for the unforeseen disruptions and costs to
medical research nationwide.
Dr. Collins, I am wondering if you can speak to the toll that the
pandemic has taken on medical research nationwide and what Congress
might be able to do to help.
Answer. The National Institutes of Health (NIH) remains deeply
concerned and mindful about how the spread of coronavirus disease 2019
(COVID-19) has negatively affected the biomedical research
enterprise.\4\ Last summer, the NIH estimated it would cost at least
$10 billion to restart labs which were forced to rapidly close. That
original estimate proved overly optimistic as the pandemic subsequently
continued, and as such, the NIH now estimates the financial impacts to
be approximately $16 billion on the biomedical and behavioral research
enterprise.
---------------------------------------------------------------------------
\4\ https://nexus.od.nih.gov/all/2020/11/04/continued-impact-of-
covid-19-on-biomedical-research/.
---------------------------------------------------------------------------
The estimates considered many factors:
--Key resources, such as animal colonies, cell lines and expired
reagents that need to be re-established.
--Access to core facilities that was limited due to a backlog of
requests.
--Delicate and complicated equipment that required recalibration and
quality control testing prior to returning to routine use.
--Requirements for social distancing to protect staff and clinical
trial participants coupled with anticipated reluctance by
participants to travel, which slowed the rate of clinical trial
accrual and progress and increased the cost of conducting
trials.
In addition to the financial estimates, the NIH fielded two online
surveys to objectively document COVID-19's impact on the extramural
research workforce.\5\ The main finding from the surveys was that the
majority of respondents noted concerns about research functions,
research productivity, and financial status.\6\ Well into the pandemic,
many NIH-supported research labs enforced social distancing, inherently
restricting access and severely limiting the ability to generate
research results and preliminary data at a crucial time in career
development of early stage investigators and trainees. Junior faculty,
often with only a single NIH award and unable to access their labs to
generate additional data, are at risk of losing all funding and may
have insufficient data to write papers while working from home. Some
investigators, especially women with dependent care responsibilities,
are more negatively affected. Investigators supported by training or
career development awards are experiencing hiring freezes and job
revocations, jeopardizing the ability of early-stage career
investigators to transition to independence, particularly as they come
to the end of their current funding. Clinical investigators have been
diverted from their research labs to meet the clinical demands of
COVID-19 patient care.
---------------------------------------------------------------------------
\5\ https://nexus.od.nih.gov/all/2020/10/05/encouraging-
participation-in-upcoming-nih-surveys-to-identify-impacts- of-covid-19-
on-extramural-research/.
\6\ https://nexus.od.nih.gov/all/2021/03/25/the-impact-of-the-
covid-19-pandemic-on-the-extramural-scientific-workforce-outcomes-from-
an-nih-led-survey/.
---------------------------------------------------------------------------
Considering these effects, the NIH is concerned about potential
pandemic-related losses of scientists exiting the biomedical research
workforce and abandoning scientific careers to seek alternative
employment. In an effort to address the unanticipated impacts of the
pandemic on the career trajectories of early career scientists, the NIH
has provided several policy flexibilities, including grant award
extensions (both funded and un-funded), opportunities for investigators
to extend the timeline for early career status, provided administrative
supplements, and more.
______
Questions Submitted by Senator Brian Schatz
Question. At the hearing, we discussed psychedelic drug research
and the potential of these drugs to treat mental health illness. You
stated that the NIH would consider having a workshop on this subject.
What is the current status of NIH-funded clinical trials involving
human subjects on the potential benefits of psychedelics combined with
psychotherapy?
Are there statutory or regulatory barriers to NIH pursuing or
funding human subject research on psychedelic drugs?
When does NIH plan to convene a workshop on psychedelic drug
research?
Answer. The National Institutes of Health (NIH) supports research
on the development and testing of pharmacological interventions--
including the use of hallucinogens such as ketamine, and psychedelic
drugs such as psilocybin--for the treatment of illnesses. In
particular, the National Institute of Mental Health (NIMH) requires an
experimental therapeutic approach for the development and testing of
therapeutic interventions for mental illnesses, in which the studies
not only evaluate the clinical effect of an intervention, but also
generate information about the mechanisms underlying a disorder or an
intervention response. Research on psychedelic drugs holds promise for
uncovering mechanisms of mental illnesses and possible interventions,
ultimately leading to novel treatments with fewer side effects and
lower abuse potential. Further research is needed to examine the
efficacy and long-term safety of psychedelic drugs, including with
repeated exposure and potential interactions with existing treatments.
The dissociative anesthetic ketamine has recently emerged as an
effective fast-acting antidepressant.\7\ The NIMH Director's Message,
``New Hope for Treatment-Resistant Depression: Guessing Right on
Ketamine,'' describes the role of NIMH and other researchers in the
development of esketamine, a U.S. Food and Drug Administration-
approved, rapid-acting medication that targets treatment-resistant
depression.\8\ Within the NIMH Intramural Research Program, Dr. Carlos
Zarate is now conducting clinical trials to better understand how
ketamine rapidly reduces depressive symptoms in people with treatment-
resistant depression or bipolar depression.\9,10\
---------------------------------------------------------------------------
\7\ pubmed.ncbi.nlm.nih.gov/27839782/.
\8\ www.nimh.nih.gov/about/director/messages/2019/new-hope-for-
treatment-resistant-depression-guessing-right-on- ketamine.
\9\ clinicaltrials.gov/ct2/show/NCT03065335.
\10\ clinicaltrials.gov/ct2/show/NCT03973268.
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The National Institute on Drug Abuse (NIDA) currently supports a
clinical trial which aims to assess the efficacy of ketamine, in
combination with behavioral therapy, in the treatment of cocaine use
disorders.\11\
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\11\ clinicaltrials.gov/ct2/show/NCT03344419.
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Additionally, a privately funded clinical trial is assessing the
potential efficacy of the psychedelic drug psilocybin for the treatment
of obsessive-compulsive disorder.\12\ While the NIH is not directly
funding this trial, NIMH does support the trial's principal
investigator through a Mentored Patient-Oriented Career Development
Award.\13\
---------------------------------------------------------------------------
\12\ clinicaltrials.gov/ct2/show/NCT03356483.
\13\ reporter.nih.gov/project-details/10127338.
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Further, a number of NIH-funded researchers are conducting basic
and preclinical research to investigate the use of psychedelic drugs as
potential therapeutic interventions for mental illnesses. For example,
NIMH-funded researchers are examining the mechanisms underlying the
antidepressant effects of psychedelic drugs in an effort to develop
novel, non-hallucinogenic treatment strategies that are both safer and
more effective than existing treatment options.\14\
---------------------------------------------------------------------------
\14\ reporter.nih.gov/project-details/10003396.
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As with all human subjects research, clinical research on
psychedelic drugs is governed by several statutes, regulations, and
policies intended to protect the rights and welfare of research
participants. For example, NIH has specific requirements for research
staff and policies regarding research conduct, safety monitoring, and
reporting of information about research progress.\15\ In accepting an
award that supports human subjects research, the recipient institution
assumes responsibility for all research conducted under the award,
including protection of human subjects at all participating and
consortium sites.\16\ All human subjects research must also be
reviewed, approved, and monitored by an Institutional Review Board.\17\
---------------------------------------------------------------------------
\15\ grants.nih.gov/policy/humansubjects/policies-and-
regulations.htm.
\16\ grants.nih.gov/grants/policy/nihgps/html5/section_4/
4.1.15_human_subjects_
protections.htm.
\17\ www.fda.gov/regulatory-information/search-fda-guidance-
documents/institutional-review-boards-frequently-asked-questions.
---------------------------------------------------------------------------
Because psychedelic drugs are controlled substances, clinical
research using psychedelic drugs must also follow Drug Enforcement
Administration requirements, including registration, inspection, and
certification of the drugs.\18\
---------------------------------------------------------------------------
\18\ grants.nih.gov/grants/policy/nihgps/html5/section_4/
4.1.5_controlled_substances.htm.
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From April through June 2021, the Trans-NIH Integrative Medicine
Course Organizing Committee hosted a series of research talks on
psychedelic drugs.\19\ Building on these research talks, NIMH and NIDA
are now working together to convene a scientific workshop in winter
2021. This workshop will bring together leading researchers to examine
the state of the evidence for the use of psychedelics in the treatment
of mental illnesses.
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\19\ events.cancer.gov/nci/psilocybinresearch/agenda.
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Question. The United States shares a unique political relationship
with the Native Hawaiian community. Different Federal agencies within
HHS are responsible for the administration of Native healthcare
programs, but the same Federal trust responsibility requires the
provision of comprehensive, quality healthcare to Native Hawaiians,
Alaska Natives and American Indians. In 2015, NIH established the
Tribal Health Research Office within the Office of the Director to
coordinate tribal health research activities across NIH. However, no
such research office exists for Native Hawaiians.
Would you consider expanding the scope of the Tribal Health
Research Office to include Native Hawaiians? Would this help to
increase the number of Native Hawaiian researchers and the amount of
Native Hawaiian research being conducted across the country?
Has NIH set any goals for the Tribal Health Research Office, and
how will you measure its success and impact across NIH's Institutes and
Centers?
Some funding opportunities at NIH, such as the Native American
Research Centers for Health program, do not permit entities serving
Native Hawaiian communities to apply. Why are these entities excluded,
and would NIH consider including these entities in the eligibility for
these grant opportunities?
Answer. The National Institutes of Health (NIH) Tribal Health
Research Office (THRO) does not conduct disparity research on Native
American populations. THRO ensures that the NIH fulfills its
obligations to Indian Tribes as federally recognized sovereign nations,
conducts government to government interactions appropriately, and holds
formal Consultations with Tribal governments on policy, regulatory, and
legislative issues that have a significant direct impact on Indian
Tribes.
The National Institutes of Health (NIH) published the NIH Strategic
Plan for Tribal Health Research with input from American Indian/Alaska
Native (AI/AN) Communities and the NIH Tribal Advisory Committee (TAC).
The plan includes four agency-wide strategic goals: enhancing
communication and collaboration; building research capacity for AI/AN
communities; expanding research; and enhancing cultural competency and
community engagement. The Tribal Health Research Office (THRO), along
with the NIH Institutes and Centers (ICs), developed processes and
metrics for evaluating progress on the strategic objectives and their
supporting action items to achieve these goals. THRO regularly collects
data on AI/AN health research activities from all ICs through an
automated process to analyze the NIH research portfolio, assess
progress towards the strategic goals, and measure impact across NIH.
The National Institute of General Medical Sciences in conjunction
with multiple NIH Institutes, Centers, and Offices (ICOs) partner with
Indian Health Service (IHS) to support the Native American Research
Centers for Health (NARCH). NARCH grant applications are submitted by
and awarded to a tribe or tribal organization, who are sovereign
nations with distinct governing bodies. Awarding the grant directly to
the tribe or tribal organization allows for the community to dictate
and oversee research priorities, while drawing upon necessary expertise
from the research community to accomplish its scientific goals.
______
Questions Submitted by Senator Joe Manchin, III
Question. West Virginia is consistently ranked last in the nation
for health outcomes. In 2020, the America's Health Rankings Report
ranked West Virginia 50th for premature deaths, frequent mental
distress, and multiple chronic conditions. We also rank last in life
expectancy. West Virginia has, in many ways, been left behind as
medical advances have saved lives in other places.
What is NIH doing to bridge this gap in health outcomes?
How do you ensure that the medical research that you do benefits
people in poor, rural communities?
How can we better expand the access rural Americans have to
successful medical treatments, particularly in states like mine where
the disease burden is so high?
Answer. The National Institutes of Health (NIH) recognizes the
unique health disparities that rural communities face, and as such,
rural health is an important area of research for the agency.
Through diverse collaborations and partnerships with communities,
academic institutions, and state agencies, NIH supports and conducts
rural health research to improve health outcomes and reduce rural
health disparities with a special emphasis on the poor in rural
communities. In fiscal year 2020, NIH supported more than 1,000 rural
health-related grants for approximately $728 million. In 2020, West
Virginia received approximately $45.7 million in funding from NIH, of
which about $6.4 million supported research and research capacity-
building activities related to rural health.
In 2019, NIH held the Inaugural NIH Rural Health Seminar, a
collaboration of several NIH Institutes and Centers to explore topics
in rural health and opportunities for research collaborations to
improve rural health outcomes. In 2020, NIH hosted a virtual rural
health conference entitled, NIH Rural Health Seminar: Challenges in the
Era of COVID-19. In October 2021, NIH will host the Pathways to
Prevention Workshop: Improving Rural Health Through Telehealth-Guided
Provider-to-Provider Communication, a virtual event to identify
research gaps, explore barriers, and facilitate successful, sustainable
implementation of provider-to-provider telehealth in rural settings.
NIH's rural health research focuses on key areas aimed at
addressing health disparities that rural populations in West Virginia
and around the United States experience. In fiscal year 2020, in
response to the disproportionate impact of coronavirus disease 2019
(COVID-19) on racial and ethnic minority, and other vulnerable
communities including rural populations, NIH established the Rapid
Acceleration of Diagnostics for Underserved Populations (RADx-UP)
initiative. The overreaching goal of the RADx-UP initiative is to
understand the factors associated with disparities in COVID-19
morbidity and mortality and to lay the foundation to reduce disparities
for those underserved and vulnerable populations more impacted by
COVID-19. One example of a RADx-UP project in your state, is the
Developing Novel Strategies to Increase COVID-19 Testing among
Underserved and Vulnerable Populations in West Virginia through
Community and State Partnerships. This project will implement
collaborative strategies to increase availability and uptake of severe
acute respiratory syndrome coronavirus 2 (SARS CoV-2) testing among the
medically underserved, rural West Virginia population that includes
multiple vulnerable groups at risk for severe COVID-19 and death. This
initiative will test whether those implemented strategies, including
home test kit and mobile unit mechanisms, successfully increase
testing, and if not, determine why the interventions did not work to
inform future sustainable testing policy.
In addition, NIH supports the West Virginia University Health
Sciences TME CoBRE project, which focuses on the microenvironment of
different tumor types, including cancers initiating in the bone marrow,
head and neck, breast, and brain. This project will increase
understanding of the constant interaction between the tumor and its
environment, provide diverse training opportunities and mentoring
strategies for junior faculty, and develop critical infrastructure and
recruit additional tumor microenvironment focused scientists to West
Virginia. Another project, the West Virginia Clinical and Translational
Science Institute: Improving Health through Partnerships and
Transformative Research (WVCTSI), leads statewide collaborations and
innovation in clinical and translational research. This project will
build sustainable research infrastructure, recruit clinician scientists
and translational researchers that excel in team science, and actively
engage with multiple stakeholders that include communities, medical
providers, and policy makers to improve the health of West Virginians.
NIH is committed to ensuring that there are opportunities for poor
rural Americans to access the benefits of research and that research
addresses the unique strengths and challenges of rural communities by
supporting several initiatives focused on human immunodeficiency virus
(HIV), cardiovascular disease, cancer, drug addiction, and other
chronic diseases disproportionately affecting rural communities. First
announced in April 2018, the NIH Helping to End Addiction Longterm\SM\
Initiative, or NIH HEAL\SM\ Initiative, is an expansive agency-wide
effort. It spans basic, translational, clinical, and implementation
science and promotes collaborations of all types of research to address
the crises of opioid misuse, addiction, and overdose in the United
States. Launched in fiscal year 2020, Strategies to Improve Health
Outcomes and Reduce Disparities in Rural Populations supports research
to promote a greater understanding of the challenges faced by rural
populations in developing or adapting evidence-based interventions that
can reduce health risks faced by rural Americans. A total of eight
awards were funded including: Harnessing the Power of Peer Navigation
and mHealth to Reduce Health Disparities in Appalachia which is using a
community-based approach to integrate peer navigation and mobile health
strategies to develop a culturally congruent, bilingual intervention to
increase the use of HIV, sexually transmitted infection, and Hepatitis
C prevention and care services among individuals with health
disparities living in rural Appalachia. Another study, Heart of the
Family: A Cardiovascular Disease and Type 2 Diabetes Risk Reduction
Intervention in High-Risk Rural Families is examining the effects of a
family focused, lifestyle intervention that is culturally tailored for
use with rural Hispanic or Latino and non-Hispanic or Latino adults. In
2020, the National Institute on Minority Health and Health Disparities
(NIMHD) funded four rural Resource Hubs to focus on rural health
research. These hubs will involve coalitions of researchers and
community partners to build research capacity in an identified rural
catchment area and offer opportunities to share resources and data
across collaborators.
NIH continues to support the Accelerating Colorectal Cancer
Screening and Follow-Up Through Implementation Science (ACCSIS)
Program, a Cancer Moonshot? Initiative, designed to reduce cancer
screening disparities. The aim is to identify evidence-based
interventions and identify promising approaches for bringing these
interventions to unscreened populations. Researchers test interventions
such as mailing programs for home testing, provider education, and
clinic-based patient navigation among Medicaid, rural, and racial and
ethnic minority groups. In fiscal year 2020, NIH reissued and released
the Pragmatic Research in Healthcare Settings to Improve Diabetes and
Obesity Prevention and Care funding opportunity announcement. This
initiative aims to improve diabetes and obesity prevention and/or
treatment that are adapted for implementation in healthcare settings
where individuals receive routine medical care. One of the funded
grants, Telemedicine for Reach, Education, Access, Treatment and
Ongoing Support (TREAT-ON), is a diabetes educator-driven, primary
care-based telemedicine model that redesigns primary care practice to
provide access to real-time ongoing support and help high risk
participants in an underserved rural community to achieve and sustain
improvements in clinical, psychosocial and behavioral outcomes. The NIH
Minority Health and Health Disparities Strategic Plan 2021-2025 aims to
test best practices for dissemination and implementation of minority
health and health disparities research in diverse diseases and
conditions into rural communities.
Continued collaborations and partnerships with scientists and
organizations from rural communities, such as West Virginia, will
contribute to NIH's reach in rural communities and support our work to
combat rural health disparities.
Question. The NIH funds the WV Clinical and Translational Science
Institute at West Virginia University through a 5-year $20 million
grant. The Institute provides critical health research across West
Virginia and has successfully mentored early career investigators,
established pilot project funding, and created a research network
across 27 primary care sites. Their research has focused on important
health issues in my state including lung disease in coal miners, opioid
addiction, and the hepatitis C epidemic, as well as cancer, heart
disease, and stroke. Most recently, the Institute has been on the front
line of COVID-19 research, having received a $1.5 million NIH Grant to
lead an 8-state effort so that data from COVID-19 patients could be
analyzed to develop the most impactful COVID-19 research. They're also
responsible for utilizing the NIH RADx grant to scale up COVID-19
testing in WV Communities.
Can you comment on the importance of continued collaboration
between the NIH and research institutions like the WV Clinical and
Translational Science Institute at West Virginia University?
What more can we be doing to support young researchers, such as
those mentored through this Institute?
Answer. One of the core programs supported by the National
Institute of General Medical Sciences (NIGMS) Institutional Development
Award (IDeA) is the IDeA Networks for Clinical and Translational
Research (IDeA-CTRs), which includes the West Virginia Clinical and
Translational Science Institute (WV CTSI). The IDeA-CTR network aims
to:
--Support the development and/or enhancement of infrastructure and
human resources required to address clinical and translational
research needs in IDeA-eligible states and jurisdictions;
--Strengthen clinical and translational research that addresses the
broad spectrum of health challenges faced by populations in
IDeA-eligible regions; and
--Foster and coordinate collaboration in clinical and translational
research within an IDeA-CTR network and with other
institutions.
Strengthening and expanding the capacity for clinical and
translational research in IDeA-eligible states is a pressing need,
since health conditions such as obesity, diabetes, cardiovascular
diseases, cancer, infectious diseases, chronic obstructive pulmonary
disease, maternal health issues, and substance use disorders are
disproportionally present in and borne by communities in these states.
The IDeA-CTR networks support health research professionals who have
first-hand knowledge of these challenges in order to understand and
improve the health outcomes of residents in affected jurisdictions.
Having the WV CTSI in place during the coronavirus disease 2019 (COVID-
19) pandemic, for instance, has allowed it to act as a springboard for
West-Virginia-based research aimed at studying and addressing the
virus. The $1.5 million supplemental award referenced in this question
facilitated the development of an eight-state consortium that created
an IDeA State COVID-19 Patient Registry. Through the collaboration
between the NIH and WVU, the Registry has become a key component of the
National COVID Cohort Collaborative, making important contributions in
addressing the unique challenges brought by COVID-19 to traditionally
underserved groups such as rural populations. Another supplement to the
WV CTSI supports a network for conducting COVID-19 testing in West
Virginia that includes the state health department, the national guard,
and rural clinics. This collaborative effort is playing a major role in
facilitating the state's testing efforts. Finally, the WV CTSI is also
a key participant of an NIH-sponsored multi-site Post-Acute Sequelae of
SARS-CoV-2 (PASC) study of ``Long COVID'' patients who continue to
experience symptoms long after initial infection.
Both NIGMS and NIH remain committed to supporting IDeA-CTR networks
like the WV CTSI, given the very important role that such networks play
in developing research infrastructure and improving health outcomes
within IDeA states.
The National Institutes of Health (NIH) believes that supporting
early career researchers is crucial to maintaining a productive,
innovative, and diverse biomedical research workforce that can continue
to advance the vitality of the scientific research enterprise. NIH's
Next Generation Researchers Initiative (NGRI) is developing and
implementing strategies to identify, support and retain investigators
across early career stages.
As part of the NGRI, NIGMS has prioritized and included several
strategies for supporting trainees and early-stage investigators (ESIs)
within its 2021-2025 Strategic Plan, along with targets for
implementing those strategies that provide accountability and the
ability to measure progress. Career development initiatives such as the
recently launched Maximizing Opportunities for Scientific and Academic
Independent Careers (MOSAIC) program focus on retaining and supporting
postdoctoral scholars from diverse backgrounds through the critical
point of transitioning them into independent faculty careers.
Cooperative agreements with professional organizations support
educational activities that equip MOSAIC scholars with professional
skills, mentoring, and career networks. At the individual level, grants
such as NIGMS' Maximizing Investigators' Research Award (MIRA) offer
support to early-stage investigators (ESIs) by providing them both the
opportunity to perform creative and ambitious research as well as the
flexibility to follow important new research directions and scientific
insights. Since launching this award mechanism in 2015, MIRA has
supported 628 early-stage investigators (ESIs), at least two of whom
were in West Virginia. In fiscal year 2020 alone, NIGMS funded 200 ESIs
through MIRA. As these examples illustrate, both the NIGMS and NIH
remain committed to supporting promising early career investigators in
every state in the nation.
______
Questions Submitted by Senator Roy Blunt
Question. Dr. Collins, I am a big supporter of the Clinical and
Translational Science Award (CTSA) program. I believe we should look
for ways to strengthen the CTSA program and reinforce the hubs around
the country. That is why I am troubled to hear about a possible CTSA
reorganization that will be announced in June. This reorganization
comes with limited discussion and consultation with the CTSA directors.
I am concerned, specifically, with the proposal to break up hub awards
into smaller pieces, requiring CTSAs to write several grant
applications instead of just one. Dr. Collins, I have two questions.
First, as you know, this Committee pays a lot of attention to CTSAs and
has been concerned in the past about communication between NCATS and
the CTSA community. For example, NCATS emailed relevant stakeholders to
combat the rumors about changes to the CTSAs, but did not provide any
relevant data to explain what they want to do and why they want to do
it. That did nothing but add to the concerns and speculation in the
community.
Why haven't these specific changes been discussed broadly within
the CTSA community? I believe if there was open dialogue and a stronger
partnership between NCATS and CTSAs, there would likely be more buy-in
from the community.
Two, how does cutting the hub award and requiring CTSAs to compete
for multiple awards strengthen the program? It appears to me that this
change would bring uncertainty to the program and jeopardize the
stability of the hubs.
Answer. The Clinical and Translational Sciences Award (CTSA)
program is indeed a very valuable and important program for the
National Center for Advancing Translational Sciences (NCATS), NIH, and
the nation. NCATS understands that there are often concerns when there
are planned updates to a program, particularly one as large and
impactful as the CTSA Program. The planned updates are part of the
regular NIH business process for reissuing Funding Opportunity
Announcements (FOAs), which is required because FOAs expire after 3-4
years. The planned updates will maintain the structure of the program
and reflect the public input received--much of which was provided by
the CTSA hub institutions and investigators. The planned updates are
designed to strengthen the program, by prioritizing hub strengths,
streamlining the overall application process, emphasizing clinical
partnerships which are critical to achieving the objectives of this
national program, and stabilizing the funding provided to the hub
institutions by allowing up to 7 years of funding (rather than the
typical five-year award period for NIH awards).
How NCATS Engages with the CTSA Community: NCATS agrees that a
strong partnership is extremely important and works closely with the
CTSA community on a regular basis.
--Regular Meetings: A CTSA Steering Committee \20\ including
leadership from NCATS and the CTSA Principal Investigator
community, meets monthly. A monthly webinar for all CTSA
Program investigators also shares information about the
program. NCATS CTSA leadership and program officers also
routinely engage with investigators and institutional
leadership across the CTSA Program as part of their regular
duties for implementing a program of this size and complexity.
In addition, there are yearly multi-day conferences where the
CTSA investigators and NCATS staff engage deeply on important
issues related to the CTSA program.
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\20\ clic-ctsa.org/groups/steering-committee.
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--Engaging the Community on Updates to the Planned FOA: To maintain
fair and open competition for funding opportunities, NCATS
cannot discuss specific details about a draft FOA with select
groups of the public, particularly those who already have
funding and would be re-competing for the funds. The level of
engagement must be framed to ensure that all investigators and
institutions, not only the current awardees, have an equal
opportunity to compete for the program funds and that NCATS
officials act impartially and not give preferential treatment
to any organization or individual.\21\ In following these NIH
policies, NCATS provided multiple opportunities to ask for and
receive input from the broader public, including the CTSA
community, on how to improve the CTSA Program.
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\21\ ethics.od.nih.gov/principles-ethical-conduct-government-
officers-and-employees.
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--A key approach for input was a Request for Information (RFI)
released in the Fall of 2019. The comments received, many
from the CTSA community, significantly influenced the
updates to the CTSA Program that NCATS is planning. (RFI;
NOT-TR-19-027 \22\)
---------------------------------------------------------------------------
\22\ grants.nih.gov/grants/guide/notice-files/NOT-TR-19-027.html;
(see this video,www.youtube.
com/watch?v=LDBJSl-_QbQ, for an overview presentation of feedback
received).
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--General feedback was sought from CTSA application peer reviewers
over multiple study sections; many of whom are also CTSA
investigators.
--Informal discussions occurred with CTSA Program consortium
members, individually and in small group settings, over the
course of typical program oversight and interactions.
--Often the first public discussion about a future FOA occurs when
NCATS, like other NIH Institutes and Centers, seeks concept
approval from its Advisory Council during a session open to
the public. This occurs on June 11, 2021. Of note, the
NCATS Advisory Council includes three members that are
Principal Investigators from the CTSA Program.
--In addition, NCATS has built in additional time after the release
of the new FOA--6 months, instead of 2-4 months, prior to
the first application receipt date--to familiarize all
potential applicants with the new FOA, including hosting of
webinars to provide technical assistance to the applicant
community.
--NCATS widely shared a communication to address inaccuracies and
rumors about changes to the CTSA Program FOA. The letter
did not discuss planned changes to the CTSA Program nor
provide data, as sharing details about the FOA in a non-
public manner prior to its posting is not permissible.
--Summary of Stakeholder Feedback: From the input received through
the multiple approaches described above, stakeholder
feedback centered around four distinct areas: (1)
decreasing application administrative burden, (2)
increasing Hub flexibility and Hub specialization
opportunities, (3) expanding Hub funding options, and (4)
preserving partnerships and collaborations. Three
additional areas were identified by NCATS for improvement:
(1) ensuring the CTSA Program's sustainability (in terms of
avoiding the need to reduce the number of hubs or cut
budgets), which requires updates to budget formulas and
calculations; (2) increased emphasis towards addressing
health disparities; and (3) strengthening clinical research
capabilities, which have been critical to the national
responses to the opioid epidemic and the coronavirus
disease 2019 (COVID-19) pandemic.
Hub Budgeting: NCATS takes the proper stewardship of taxpayer funds
very seriously. NCATS does not intend to change the number of hubs or
the amount of funding dedicated to the hub core awards. Future award
amounts will be based on the amount requested by each applicant and
will follow a revised formula for classifying the size of awards from
what is currently used. In addition to incorporating feedback from
different stakeholders, one of NCATS' objectives is to ensure the long-
term sustainability of the program while avoiding a reduction in the
number of hubs or reducing hub budgets to stay within the appropriated
budget for the program. Requested budgets for CTSA awardees have been
increasing to the highest award size under the CTSA graduated award
structure, which is not sustainable under current funding for the
program, so a restructured award calculation is needed. The total award
size of future hubs is anticipated to be similar to the current awards
for the vast majority of awardees.
Structure of the Program Applications: NCATS considered extensive
public feedback, outlined above, in updating the CTSA Program FOA,
including how these updates could contribute to stabilization for the
awardees and to sustainability of the program. To date, the application
process for institutions applying for CTSA hub awards has been
complicated and burdensome, linking up to three separate activities
together into one package, the U54 application. Linking the Hub, Career
Development, and Training activities together for application
submission and peer review is primarily for the benefit of NIH in being
able to track these activities. However, based on feedback, it places
substantial burden on the applying institution in the form of
developing large, complex applications, often containing several areas
of duplicate information. The review of three separate activities in
one application risks pulling an institution out of funding range, due
to one of the activities not faring well in peer review. Applicants
that do not successfully compete face a prolonged period of uncertainty
for funding, while having to address, revise, and resubmit the entire
U54 application package for a subsequent review cycle. These factors
combined with the duration of the awards--five years --raises the
stakes of each application and contributes to an environment where
applying and awarded institutions are in a constant state of
application preparation.
Stakeholder concerns about the complexity of the current
application are an important and consistent piece of feedback NCATS
received. Separating the applications will streamline the submission
process for each component, will reduce duplication of information in
an application, will result in less reliance on the success of one part
of the application, will avoid the risk of significant delays in
awarding a hub if the Training or Career Development components are not
strong, and may allow better alignment of Training and Career
Development awards with the clinical training calendar. Separating the
Hub application from the training and career development applications
will also allow the Hub application, which is the key institutional
award, to be awarded for up to 7 years, more than the standard 5 years.
With this strategy, NCATS intends to provide further stability to an
institution's funding by extending the Hub award. Combining all
applications together does not allow for that seven-year Hub award
option, as NIH limits training and career development awards to 5
years. Separating the applications and providing the additional planned
funding opportunities will also give the institutions more control over
where they place their priorities based on their own strengths, another
key piece of feedback received through stakeholder input.
In closing, we hope that these responses have addressed your
concerns. If not, NCATS is happy to provide additional information.
NCATS recognizes the significance of the CTSA Program. The pandemic has
further served to highlight the importance of this program in
responding to emerging clinical and translational needs at local,
regional, and national levels. NCATS' intent with the proposed updates
to the CTSA FOA is to strengthen the program, provide additional
funding stability, and continue to incorporate research to tackle
health disparities through this program. NCATS also wants to address
important concerns raised by the CTSA community to streamline
application and award preparation processes, continue to emphasize the
importance of partnerships, and allow institutions more flexibility to
leverage their strengths in contributing to this important national
resource.
Question. Dr. Collins, the impact of COVID-19 has been
significant--both to Americans physical health, but also to their
mental health. The fiscal year 2022 budget includes $25 million for
focused research on the impact of the pandemic on mental health.
Can you discuss what research areas this funding will be focused on
and how the All of Us research initiative will play a role in
understanding the full impact of the pandemic?
Answer. The All of Us Research Program's participants come from
diverse communities across the United States and generously donate
their data and time to drive a wide range of biomedical discoveries,
which are vital for informing public health strategies and
preparedness. Due to the diverse nature of the program, the All of Us
Research Program will play a vital role in understanding the mental and
physical impact of the pandemic across the United States and within
some of the hardest-hit communities. All of Us began to address the
challenge of the coronavirus disease 2019 (COVID-19) pandemic in May
2020 by leveraging its significant and diverse participant base to seek
new insights into COVID-19 and its impact through an online COVID-19
Participant Experience (COPE) survey.\23,24\ The COPE surveys focused
on understanding the mental and physical impacts of the COVID-19
pandemic on participants and included questions on symptoms, stress,
social distancing, social determinants of health, and economic impacts.
Participants were invited to take the survey in May, June, July,
November, and December 2020, and February 2021. This multi-pronged
assessment will enable researchers to study the effects of COVID-19
over time and better understand how COVID-19 affects people's mental
and physical health differently. To date, over 10,000 participants
completed all six COPE surveys and over 100,000 completed at least one
COPE survey during the pandemic, with 70 percent of those participants
coming from a community that is historically underrepresented in
biomedical research.
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\23\ allofus.nih.gov/news-events-and-media/announcements/all-us-
research-program-launches-covid-19-research- initiatives.
\24\ www.nlm.nih.gov/dr2/
COPE_Survey_NIH_All_of_Us_Clean_4.27.20.pdf.
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In addition to COPE, All of Us tested blood samples from over
24,000 participants collected between January 2 and March 18, 2020, for
the presence of SARS-CoV-2 antibodies, which provided evidence of
infection in five states prior to initial reports. The program
anticipates making the full results of this study available in June
2021.\25\ Additionally, All of Us is collecting relevant electronic
health record (EHR) information from more than 246,000 participants,
some of whom have been diagnosed with COVID-19 or sought healthcare for
related symptoms, to help researchers look for patterns and learn more
about the physical and mental health impacts of COVID-19 and the
effects of different medicines and treatment. As data are made
available from all of these efforts, researchers will look for new
leads that may bring greater precision to the diagnosis, treatment, and
prevention of COVID-19, including those communities that have been hit
the hardest. The program will make data gathered through these
activities broadly accessible to approved researchers on a rolling
basis, in future releases of its secure data platform, the Researcher
Workbench.\26\ The program will continue to explore additional ways it
can leverage its unique and diverse dataset to answer critical research
questions to enhance our understanding about the full impact of the
pandemic, especially with a focus on mental health.
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\25\ The results of this study were announced on June 15, 2021;
complete details at: allofus.nih.gov/news-events-and-media/
announcements/nih-study-offers-new-evidence-early-sars-cov-2-
infections-us.
\26\ www.researchallofus.org/.
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Question. Dr. Collins, the COVID-19 pandemic highlighted the need
to use non-human primates (NSP) in research. The budget requests $30
million for NSP infrastructure.
Can you provide further details to the Committee on the need for
this funding and details on how this funding would be allocated and to
whom?
What types of research would be at jeopardy if NSPs were not
replaced or expanded?
Answer. The National Institutes of Health (NIH) remains committed
to protecting animal welfare while, at the same time, advancing
biomedical research and human health. The budget request for $30
million for nonhuman primate infrastructure would cover facilities used
to house nonhuman primates which require continual updates and
maintenance to ensure responsible stewardship over these invaluable
resources. The funds in the budget request would be distributed by
soliciting applications from NIH grantees to improve existing
facilities, not to establish new nonhuman primate facilities. Several
nonhuman primate facilities have existed for over 60 years and housing
enclosures require frequent repair and replacement. New construction
for research facilities would include animal holding rooms, necessary
equipment such as surgical tables, centrifuge, ultrasound, clinical
analyzer, procedure, and veterinary clinical support in order to meet
or exceed the current high-level care of the nonhuman primates.
Additionally, the COVID-19 pandemic highlighted the need for new
construction to expand animal biosafety level 3 areas in order to have
biocontainment facilities associated with nonhuman primate facilities.
In addition to ethically appropriate housing, nonhuman primates require
a proper diet, clinical/veterinary care as well as psychological and
environmental enrichment, which necessitates skilled staff and
additional resources including supplemental produce, various enrichment
devices such as foraging devices for food, various toys, and puzzles.
NIH would support expansion at existing NIH-supported facilities to
leverage the investment. The NIH Office of Research Infrastructure and
Programs (ORIP) supports a well-coordinated national consortium of
seven National Primate Research Centers (NPRCs) and other breeding
colonies that collectively address research needs and trends, best
husbandry practices, maintenance of genetic diversity, standardization
of models, ethics, rigor, and reproducibility. NPRCs are national
resources serving not only NIH-funded investigators but other federally
funded investigators, foundations, and industry, including many SARS-
CoV-2 projects in the last year.
Research with animal species, including nonhuman primates, remains
critical for modeling human physiology and is essential for developing
new prevention strategies, treatments, and cures for disease beyond the
need for responding to emerging infectious diseases. Nonhuman primates
have been essential for understanding human biology and developing
treatments for diseases, mostly because of our shared anatomy,
physiology, and behavior. Importantly, the genetic sequence
similarities between nonhuman primates and humans can reach up to 98.77
percent, which has made nonhuman primates models critical for studying
neurobiology, transplant tolerance and rejection, infectious diseases,
reproductive biology, and regenerative medicine. More recent
applications have been in regenerative medicine and gene therapy and
editing. There is a rapidly emerging need for marmosets in the
neurosciences where recent National Academies of Sciences, Engineering,
and Medicine (NASEM) reports and the Brain Research Through Advancing
Innovative Neurotechnologies (BRAIN) Initiative community have pointed
out that demand far exceeds supply.\27\ Another critical area of
intense need and research development is nonhuman primate models of
Alzheimer's disease to develop therapies. Nonhuman primate models are
commonly used for studies of visual systems, auditory systems,
cognitive function, and brain connectivity. The single largest
application of nonhuman primates continues to be in developing vaccines
and therapies for HIV/AIDS.
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\27\ www.nap.edu/read/25356/chapter/7.
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Research using animal models, including nonhuman primate models,
has led to tremendous advances critical for saving countless lives and
extending human life expectancy around the world. Until suitable non-
animal models are developed, the complexity of human systems, both in
health and in disease, can only be truly understood through
complementary model systems with sufficient complexity, and nonhuman
primates remain invaluable for this effort. When animal models are
required, NIH will only conduct and support research in accordance with
the highest scientific and ethical principles. To uphold these
principles, the NIH budget includes investments in nonhuman primate
facilities, resources, and enrichment.
Question. Dr. Collins, how much funding, broken down by Institute
or Center, has NIH repurposed for COVID-19 related lab reopenings or
lost research activities?
Answer. To support our recipients affected by the pandemic, the
National Institutes of Health (NIH) provided extensions, both funded
and unfunded, as well as administrative supplements, to address the
unanticipated impacts of the pandemic. The NIH has also issued multiple
funding opportunities for current recipients to repurpose existing
awards and expand the scope of ongoing research to include coronavirus
disease 2019 (COVID-19) research activities.\28\ Continued support for
these projects is contingent on satisfactory progress, the availability
of funds, and NIH Institute and Center (IC) funding priorities, which
continue to change as the pandemic, and research on COVID-19
progresses.
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\28\ grants.nih.gov/grants/guide/COVID-Related.cfm.
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Decisions related to individual awards are made by the funding NIH
IC on a case-by-case basis, taking into account those critical factors.
All requests to change the scope of an NIH grant award require prior
approval from the awarding NIH IC, as stipulated in the NIH Grants
Policy Statement, section 8.1.2.5.\29\
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\29\ grants.nih.gov/grants/policy/nihgps/HTML5/section_8/
8.1.2_prior_approval_
requirements.htm#Change4.
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The NIH continues to analyze the data on the impact of COVID-19 on
the biomedical research community, and its potential impact on NIH
budget and grant activities.
Question. It is my understanding that one of the main issues NIH
faced related to COVID-19 expenses was for post-doctoral candidates
finishing their training, research, or fellowship.
How has this issue been addressed and do you expect to see a
funding issue related to the extension of some of these grant awards
into fiscal year 2022?
Answer. The coronavirus disease 2019 (COVID-19) pandemic, along
with extensive mitigation measures, has adversely affected progress in
many biomedical research settings. Evidence from multiple sources,
including results from a survey during the fall of 2020, indicates
legitimate concerns about career trajectory for early career
scientists.\30\ Hearing these concerns, the National Institutes of
Health (NIH) issued a Guide Notice detailing our approach to support
early career scientists whose career trajectories may have been
significantly affected by the pandemic.\31\ Specifically, NIH is
providing an opportunity for recipients in their last year of NIH
Fellowship (F) and NIH Career Development (K) awards who have been
impacted by COVID-19 to request extensions.\32\ Such extensions will be
considered on a case-by-case basis, within the existing availability of
funds.
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\30\ nexus.od.nih.gov/all/2021/03/25/the-impact-of-the-covid-19-
pandemic-on-the-extramural-scientific-workforce-outcomes-from-an-nih-
led-survey/.
\31\ grants.nih.gov/grants/guide/notice-files/NOT-OD-21-052.html.
\32\ https://nexus.od.nih.gov/all/2021/02/08/extensions-for-early-
career-scientists-whose-career-trajectories-have-been-significantly-
impacted-by-covid-19/.
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Generally speaking, the NIH typically makes between 500 to 600 F
and K extensions per year, the vast majority (more than 95 percent) of
which are no-cost extensions. Only seven funded extensions were awarded
in fiscal year 2019. In fiscal year 2020, the NIH awarded 548
extensions, with 75 (14 percent) of these being funded extensions. Thus
far in fiscal year 2021, 15 funded extensions are linked to NOT-OD-21-
052, but we will have a much better sense of uptake as the fiscal year
concludes. Though there appears to be a relative increase in the number
of funded extensions commensurate with the pandemic, the absolute
numbers remain low.
______
Questions Submitted by Senator Cindy Hyde-Smith
Question. What is the fully intended scope of ARPA-H? Will it
address diseases beyond cancer, diabetes, and Alzheimer's, such as ones
with more challenging markets? Do you have examples?
Answer. The scope of the Advanced Research Projects Agency for
Health (ARPA-H) is intended to be broad and, indeed, stretch beyond the
areas initially identified by the President. There are a number of
areas with substantial unmet needs--some examples include emerging
infectious disease, rare and ultra-rare disease, and antimicrobial
resistance--and, with targeted investments over time, breakthrough
progress could be made. In addition to specific disease areas, ARPA-H
intends to build capabilities and explore various platform
technological approaches which may have broad applicability across a
range of diseases and conditions. A recent commentary in Science \33\
outlined some exciting concepts such as developing mRNA vaccines to
prevent most cancers; creating molecular ``zip codes'' to more
precisely target tissues and cell types while minimizing side effects;
deploying holistic interventions that identify those at high-risk and
leverage new telehealth approaches to eliminate racial disparities in
maternal morbidity and mortality rates and premature births; and
developing small, highly accurate, inexpensive, non-intrusive, wearable
24/7 monitors for blood pressure and blood sugar. While these examples
are meant to illustrate the breadth of potential projects that ARPA-H
could support, we believe it is projects like these that can have a
significant impact for patients who are relying on biomedical research
and innovation to live longer, healthier lives.
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\33\ science.sciencemag.org/content/373/6551/165.
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Question. Additionally, how will ARPA-H fit into the larger health
focused R&D structure? How will its role be defined as unique among the
various funding programs, and will there be coordination with other
entities such as BARDA to ensure cooperation and avoid duplication?
Answer. The Advanced Research Projects Agency for Health (ARPA-H)
is meant to become an integral component of the constellation of
agencies focused on promoting health and research and development--both
within and beyond NIH and HHS. As described in a recently published
commentary in Science,\34\ ARPA-H should be housed as a new entity
within NIH. The rationale for this organizing principle is two-fold.
First, the goals of ARPA-H fall squarely within the mission of the NIH,
which is ``to seek fundamental knowledge about the nature and behavior
of living systems and the application of that knowledge to enhance
health, lengthen life, and reduce illness and disability.'' Second, the
NIH offers a rich source of fundamental health research that will be
foundational for a constructive, collaborative, and productive
relationship with ARPA-H. We envision robust collaborations on
synergistic topics with the existing NIH Institutes and Centers, along
with organizations both outside and within the government. The added
benefit of housing ARPA-H within NIH is that it will create
administrative efficiencies so that more resources can be directed
toward the mission and help avert duplication of effort.
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\34\ science.sciencemag.org/content/373/6551/165.
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In mid-July, the Administration launched a Federal Joint Fast Track
Action Committee (FTAC) intended to help steer the creation of ARPA-H
and lay the groundwork for strong interagency coordination. OSTP and
NIH serve as co-chairs of this committee that includes representatives
from the Department of Agriculture, DARPA, Office of the Under
Secretary of Defense for Research & Engineering, ARPA-E, BARDA, CDC,
CMS, FDA, VA, EPA, NSF, and the Smithsonian Institution, among others.
Bringing these entities together at an early stage will help ensure
strong collaboration and coordination among the various research-
focused organizations throughout the Federal Government. The agency
personnel who sit on the FTAC will also be a valuable source of insight
and advice as ARPA-H is launched.
______
Questions Submitted by Senator Patrick J. Leahy
Question. I strongly support the Administration's renewed approach
to innovation in medical research through the establishment of the
Advanced Research Projects Agency for Health (ARPA-H). COVID-19 has
shown that a commitment to breakthrough innovation, directed allocation
of resources, and collaborative approaches can accelerate how
scientific breakthroughs can be transitioned to treatments and cures.
The administration has proposed that the agency will focus on
innovative treatments in cancer, Alzheimer's disease, and opioid
disorders. Several institutions in Vermont are national leaders in
these stated research fields despite their smaller and more rural
nature. While I strongly support any efforts to accelerate innovation,
I am concerned that valuable collaborators could be left out or lose
out on Federal funding, particularly if there is no traditional grant
application process.
What role will smaller and more rural research institutes play in
ARPA-H? If projects are funded outside a grant application process,
will there be established guidelines to include collaborators from
rural or traditionally underrepresented areas?
Answer. Over the long term, the proposed structure for the Advanced
Research Projects Agency for Health (ARPA-H) is intended to empower the
ARPA-H leadership and staff to set and execute on research priorities
for a variety of high-risk, high-reward, milestone-driven projects that
can lead to novel capabilities, platforms, and resources that are
applicable to a range of diseases. These priorities include the
opportunity to fund smaller and more rural research institutes.
For the initial direction, the Administration is working to set up
multiple pathways, both within the government and the broader
stakeholder community, for priority setting and for exploring new areas
ripe for research at ARPA-H. At the time of this hearing, the White
House Office of Science and Technology Policy (OSTP) and the National
Institutes of Health (NIH) are in the planning phases of convening
multiple listening sessions with key stakeholder groups including
patient organizations, industry, venture capitalists and
philanthropists, and others from the academic and research communities.
During these sessions, stakeholders will be asked to offer their
perspective on what they see as the greatest research challenges and
opportunities that could be addressed using the ARPA-H model. This
input will help refine the scope and provide a wealth of ideas for the
first ARPA-H director to consider as they develop the agency's vision.
In mid-July, the Administration established a Joint Fast Track
Action Committee (FTAC) to help steer the creation of ARPA-H and lay
the groundwork for strong interagency coordination. OSTP and NIH serve
as co-chairs of this committee that includes representatives from
Department of Agriculture, DARPA, Office of the Under Secretary of
Defense for Research & Engineering, ARPA-E, BARDA, CDC, CMS, FDA, VA,
EPA, NSF, and the Smithsonian Institution, among others.
Soliciting a diversity of perspectives and approaches will be a key
tenet of the Advanced Research Projects Agency for Health (ARPA-H).
Much like DARPA and ARPA-E, it will do so by supporting the best
strategies to solve an identified challenge and by pursuing multiple
approaches. Program managers will also have the authority to combine
proposals from different institutions to assemble the boldest, most
innovative portfolio, allowing each team to build on their strengths
while benefiting from the knowledge, expertise, and resources from
other institutions. ARPA-H will also provide awards that range in size
and mechanism--from smaller, pilot projects to develop a prototype, to
complex multi-site trials, to prizes that stimulate healthy competition
and ingenuity. Further, ARPA-H will support a Small Business Innovation
Research (SBIR) and Small Business Technology Transfer (STTR) program
with business development, commercialization, and other resources to
provide small businesses with the tools they need to be successful.
These approaches are examples of mechanisms that ARPA-H will utilize to
support a range of organizations across the country which may include
small and/or rural institutions, and its portfolio will be regularly
evaluated to ensure there is diversity of perspective. Because ARPA-H
will be a nimble, dynamic organization, it will be able to readily
pivot to experiment with new approaches.
Question. Chronic pain is a significant public health issue
affecting an estimated 50.2 million Americans each year. Based on data
from the National Health Interview Survey (NHIS), the total value of
lost productivity due to chronic pain is estimated to be nearly $300
billion annually. With little known about alternatives for treating and
managing relief from pain, medical providers are often limited to
prescribing highly addictive opioids or muscle relaxants to help
patients mitigate symptoms from pain. Scientific research suggests that
long term use of such medications can result in the body's reduction of
its own ability to fight pain. Even for patients who do not experience
direct abuse or addiction with long term use, scientists have found
that withdrawal symptoms are present when patients stop taking these
medications. Unfortunately, research into addiction and alternatives to
treatment has historically lagged at NIH. Enhanced research on chronic
pain management and treatment, other than through the use of highly
addictive opioid painkillers, has the potential to reduce substance
abuse and promote better methods for addressing pain.
I strongly support the NIH Heal Initiative to find solutions to
curb the national opioid public health crisis by understanding,
managing, and treating pain. Please describe any progress made by the
HEAL Initiative on medication development to alleviate pain and to
treat addiction. What remains the biggest barrier to research to
investigate new and alternative options to treat chronic pain?
Answer. The National Institutes of Health (NIH) recognizes the need
to improve pain management without risk of addiction and other serious
side effects. NIH is taking a multi-pronged approach to develop safe
and effective therapies to reduce our reliance on opioids and treat
addiction. The NIH Helping to End Addiction Long-term (HEAL) Initiative
launched in 2018 has awarded over $1.5 billion for research to discover
and accelerate development of non-addictive pharmacological and non-
pharmacological pain treatments, as well as treatments for opioid use
disorder (OUD) and overdose.
Through the HEAL Initiative, NIH supports over 70 targeted studies
to accelerate the development of treatments for OUD, including novel
medications and biologic agents, as well as novel formulations of
approved medications to treat OUD and prevent opioid overdose. To date,
16 Investigational New Drug Applications were filed with the U.S. Food
and Drug Administration and authorized to proceed for human studies.
These studies focus on a variety of drug targets, as well as vaccines
that could prevent opioids from entering the brain. HEAL currently
funds nine opioid vaccine projects including vaccine candidates
targeting oxycodone,\35\ fentanyl \36\ and heroin.\37\ This strategy
could offer more accessible, manageable treatment through longer-
lasting vaccines to reduce the risk of relapse.
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\35\ reporter.nih.gov/search/Pcd2IghkPU6lnJkOT7FlFQ/project-
details/9778811.
\36\ reporter.nih.gov/search/Wp_sHzUhIUuYqDimSa90iw/project-
details/9737173.
\37\ reporter.nih.gov/search/GNnJWbYvQUeIlbwhgFofXA/project-
details/9734921.
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HEAL-supported work also includes studies to identify, optimize and
test promising molecules, biologics, and devices for treating pain that
target non-opioid pathways in the nervous system. Biomarker studies to
enhance clinical trials and improve best practices are moving forward.
In addition, non-pharmacological approaches to manage many different
pain conditions are being evaluated through effectiveness and
implementation research approaches.
In these ways, HEAL is providing much needed resources to advance
research on new and safe alternatives to opioids for chronic pain. The
complexity and diverse nature of chronic pain itself along with a high
prevalence of other co-occurring chronic conditions such as diabetes,
depression, and autoimmune disorders create an enormous challenge for
advancing research.
Mechanisms for the causes of different pain conditions vary,
biomarkers for patient response to treatment and likelihood for
progression of disease also are characteristic of the disease
condition. In addition, treatments for co-morbidities require careful
balancing and often long- term multidisciplinary care. These and other
factors require an expanded breadth and scope of pain research to
better provide personalized care for those with chronic pain. The
Federal Pain Research Strategy \38\ describes research priorities to
relieve the burden of pain. The NIH HEAL initiative provided support to
move many of the report's recommendations forward.
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\38\ www.iprcc.nih.gov/federal-pain-research-strategy-overview.
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Specifically, the NIH HEAL initiative established essential pain
research infrastructure to accelerate development of new medications
and devices to treat pain. An analgesic screening platform uses animal
and human cell-based models such as neural tissue chips for rapid
screening of molecules or devices for analgesic-relevant biological and
pain behavioral activity. HEAL, with input from academic and industry
partners, established an Early Phase Pain Investigation Clinical
research network (phase 2 studies) to test safety and efficacy of novel
therapeutics and a later stage pain management Effectiveness Research
Network (ERN) to compare effectiveness of pharmacological and non-
pharmacological approaches in many different pain conditions. The
Pragmatic and Implementation Studies for the Management of Pain to
Reduce Opioid Prescribing (PRISM) network focuses on clinical trials of
non- pharmacologic pain therapies in healthcare systems. The Phase 2
network will launch trials on two new analgesics in late 2021. The ERN
is supporting eight large trials for various pain management
strategies. PRISM is supporting six large trials in healthcare systems.
In addition, HEAL established an analgesic development pipeline to
accelerate the development and testing of novel drugs and devices. This
comprehensive program uses team-based science coupled with a
comprehensive set of research resources to bring new therapeutics
rapidly to the clinic. To advance the discovery and validation of new
drug targets, HEAL has funded over 30 projects to discover and verify a
diverse set of drug target types across multiple pain conditions, six
drug optimization studies on new safe and effective pain treatments,
and 11 projects to test the effectiveness of implanted devices and
noninvasive stimulation of nerves in the brain or throughout the body
to reduce perception of pain. In addition, to improve the efficacy of
clinical trials for pain treatments, and to increase the chance that
new therapeutics will advance along the regulatory path to approval,
HEAL tests the development of biomarkers to objectively measure pain,
including pain associated with sickle cell disease, musculoskeletal
disease, nerve pain and headache. Promising biomarkers identified
through this program may advance to clinical validation through the
Early Phase Pain Investigation Clinical Network (EPPIC-Net). Findings
from these studies could improve quality of life for millions of people
in the United States who experience pain daily. Recent HEAL
accomplishments toward new therapeutics include two patent filings for
small molecule modulators of pain receptors involved in chronic pain
and migraine.
New directions for HEAL will also continue to pursue goals laid out
in the Federal Pain Research Strategy,\39\ including demonstration
projects to aid in the development of a coordinated approach to pain
management in healthcare systems. This effort would assess multi-
disciplinary and multimodal approaches to pain management embedded in
healthcare systems. Research within systems of pain care would allow
for effective interventions to be adopted into the healthcare system
and improve access for patients. Focused discussion with select
healthcare program leadership would identify pain conditions of
greatest opportunity, with an emphasis on effectiveness research,
quality management and team-based care. This effort would seek to
leverage existing infrastructure through ongoing collaborative and
interagency efforts.
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\39\ www.iprcc.nih.gov/federal-pain-research-strategy-overview.
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Another specific effort in development aims to advance health
equity to address the wide disparities in care and treatment for pain
and addiction, known to result in both the undertreatment and
overtreatment with opioids, increased risk of addiction and overdose,
lack of access to effective non-pharmacological options for pain
treatment, and lack of access to evidence-based addiction care.
Disparities in pain management exist across multiple levels: pain
assessment, treatment, and management at the patient, provider,
community, and healthcare system levels. Planned expansion to HEAL
includes the development and implementation of culturally appropriate
interventions for the prevention and management of pain and addiction
in diverse populations, with a focus on sustainable and scalable
interventions that can be rapidly implemented by healthcare systems.
In addition, recent discoveries in human genetics and molecular
biology will be incorporated into the development of a novel team-based
platform to rapidly test targets and candidate therapeutics for diverse
human pain conditions and share findings with the wider pain research
community. This research will address pain systems and allow for a
variety of research questions including conditions of chronic analgesic
use, other drug use, substance use disorders (SUDs) and other co-morbid
conditions, and will enable and accelerate human gene- and cell- based
validation of pain therapeutic targets through the HEAL initiative and
other pipelines. This will build on existing HEAL research on
preclinical and translational research in pain, and ongoing efforts to
accelerate the development of novel treatments for pain. Through these
and other efforts at HEAL and across the NIH, we aim to continue to
improve our understanding of pain and develop non-addictive, effective
therapies.
Question. Migraine is currently the second leading cause of all
global disability. Unfortunately, due in part to limited research and
treatment, inappropriate opioid prescriptions for migraine present
Americans with ongoing risks of opioid use disorders and have worsened
outcomes in patients. Overall, 6 million Americans living with
migraines are active opioid users. I strongly support the NIH Heal
Initiative to find solutions to curb the national opioid public health
crisis by understanding, managing, and treating pain. While migraine
grant proposals are eligible for consideration under the HEAL request
for applications (RFAs) issued for pain research, less than 1 percent
of HEAL Initiative appropriations have funded headache disorders
research--the least funded NIH area among all the nation's burdensome
diseases. I am very concerned about the failure to attract enough
investigators to this historically under-funded research area.
Does NIH have plans to issue specific RFA programs for headache
disorders research, comparable in scope to the Back Pain Consortium
(BACPAC) group of RFAs for research on back pain?
Answer. The National Institutes of Health (NIH) recognizes the
burden of pain at the individual and population levels and that
headache disorders are prevalent and disabling conditions which affect
millions of Americans. The NIH launched the HEAL Initiative (Helping to
End Addiction Long-term) to improve pain care and better prevent and
treat opioid use disorder. Priorities of the HEAL initiative, developed
with our stakeholders with expertise in pain research and care, include
enhanced understanding of pain, discovery and validation of novel pain
therapeutic targets, testing therapies in clinical settings, and
accelerating the process to bring new therapies to patients. The
initiatives are, or were, open to all pain conditions. The HEAL
initiative also established much needed research infrastructure to
support innovative science. Headache research fits within the scope of
all these initiatives and will benefit from the enhanced
infrastructure.
HEAL funding solicitations call for proposals across all pain
conditions. NIH staff recognizes the low submission rate of headache
applications and broadly disseminates information on HEAL and other
funding announcements to the research community to encourage
submissions. Most funding announcements specifically cite headache as
an area of interest and others are inclusive of headache. Low back pain
is an exception among pain conditions in that it has unique research
gaps such as lack of diagnostic tools and technologies, no accepted
common data elements, poor diagnostic criteria, complex etiology, and
lack of an adequate evidence base for effective practice guidelines.
The HEAL Back Pain Consortium (BACPAC) initiative was launched to fill
these extensive gaps to improve pain care across the spectrum of low
back pain.
Migraine and other headache disorders have good classification
schemas, a range of effective treatment therapies whose development was
supported by NIH research, and evidence-based diagnostic categories and
treatment protocols (International Headache Society). Our understanding
of migraine etiology is more advanced than that for back pain. NIH has
supported transformative basic research that advanced our knowledge of
migraine mechanisms, causes, and predictors, biomarker identification,
and new therapy development. For example, NIH supported investigators
provided the foundation for development of CGRP antibodies now used
widely for migraine therapy. NIH sponsored research also contributed to
understanding how migraine auras activate nociceptors and initiate a
migraine, and the mechanism of action for new migraine therapies such
as vagus nerve stimulation. Basic research on potassium channels,
delta, or kappa opioid receptors, and TRP channels fundamentally
increased our understanding of trigeminal nociceptors and their
involvement in initiating a migraine, giving us new targets for
potential treatments. An NIH sponsored pivotal pediatric migraine
clinical trial changed clinical practice for children with chronic
daily headaches.
NIH and HEAL leadership recognize that far too many headache
sufferers are prescribed opioids despite clear clinical practice
guidelines that call for non-opioid effective alternatives rather than
opioids. This practice reflects the sparsity of headache specialists
and the lack of and education of our primary care providers who are
often the first to treat those with disabling migraines. NIH also
recognizes the need to expand the headache research workforce. The HEAL
initiative recently released funding announcements to support training
and mentorship of early and mid- career researchers in the field of
basic, translational, and clinical pain research. We encourage those
interested in headache research to benefit from these opportunities.
______
Questions Submitted to Dr. Anthony Fauci
Questions Submitted by Senator Richard J. Durbin
Question. I have received a lot of questions from Illinois
families, who are hoping for more clarity on the CDC's most recent mask
guidelines. Many vaccinated parents--with unvaccinated children at
home--are wondering if they should be wearing masks when out in public.
What advice would you give to vaccinated parents who have
unvaccinated children at home?
When do you think we will have a COVID vaccine approved for
children younger than 12 years of age?
Answer. Currently authorized coronavirus disease 2019 (COVID-19)
vaccines meet the U.S. Food and Drug Administration's (FDA's) rigorous
standards for safety and effectiveness, and current data suggest that
fully vaccinated people are less likely to transmit severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) to others. According to
the Centers for Disease Control and Prevention (CDC), fully vaccinated
people--including those living with unvaccinated children or
adolescents--can resume activities without wearing masks or physically
distancing, except where required by Federal, state, local, tribal, or
territorial laws, rules, and regulations. Individuals ages 2 and older
who are unvaccinated, however, should continue to wear masks in public
and when around people who do not live in their household, except when
eating or sleeping. CDC will continue to evaluate and update public
health recommendations for fully vaccinated people as more information,
including on Delta and other new variants, becomes available.
Efforts to evaluate COVID-19 vaccines in children under age 12
currently are underway, and a COVID-19 vaccine may be available for
this age group by the end of 2021. On March 16, 2021, Moderna, in
collaboration with the National Institute of Allergy and Infectious
Diseases (NIAID) and the Biomedical Advanced Research and Development
Authority (BARDA), launched KidCOVE, a Phase 2/3 study to evaluate the
safety and efficacy of the Moderna COVID-19 vaccine in children ages 6
months to less than 12 years. Pfizer also is conducting a Phase 1/2/3
trial to evaluate its COVID-19 vaccine in this age group. In addition,
other vaccine developers are planning to begin trials to test their
vaccine candidates in children. Until a COVID-19 vaccine is available
for children under age 12, it will be important for all individuals,
especially children and other unvaccinated individuals, to continue to
follow all public health measures for COVID-19 advised by the CDC,
including frequent hand washing and the use of masks and social
distancing in certain settings.
______
Questions Submitted by Senator Joe Manchin, III
Question. My home state of West Virginia is battling an epidemic
during the middle of a pandemic. My state has been devastated by the
drug epidemic, COVID-19, and we now lead the nation in new HIV
infection rates. You have spent much of your career focused on the
prevention, diagnosis, and treatment of HIV/AIDS. Your research has
been instrumental in saving countless lives in the United States and
around the world. The National Institute of Allergy and Infectious
Diseases supports initiatives focused on diagnosing, treating,
preventing and responding to the HIV epidemic in the United States.
These efforts represent steps in the right direction, but will not
alone end West Virginia's increasing numbers of new HIV infections and
other opioid-related infectious diseases.
What is being done to replicate testing and surveillance efforts we
saw put into place for COVID-19 for other infectious diseases, like
HIV/AIDS?
What public health infrastructure would be required to bring better
infectious disease testing and surveillance to fruition?
Answer. The Federal response to coronavirus disease 2019 (COVID-19)
relied heavily on the utilization and expansion of existing resources
for human immunodeficiency virus (HIV) and other infectious diseases.
By leveraging available resources, we have been able to accelerate the
development of diagnostic tests and other medical countermeasures, as
well as surveillance and community engagement efforts. In turn,
knowledge gained from the COVID-19 response may inform strategies to
address other infectious diseases such as HIV. This includes efforts
undertaken by the U.S. Department of Health and Human Services (HHS) to
end HIV in the United States by 2030 through the Ending the HIV
Epidemic in the U.S. (EHE) initiative. EHE is coordinating across HHS
agencies and with patient, community, academic, and other partners to
plan, design, and deliver local HIV prevention and care services. This
``whole-of-society'' approach is a model for ending both the HIV
epidemic as well as the COVID-19 pandemic. Proper diagnosis and
treatment of HIV are key components of this initiative, and efforts to
improve testing and surveillance for HIV are ongoing.
An important aspect of the response to the COVID-19 pandemic as
well as the HIV epidemic is community engagement. The National
Institute of Allergy and Infectious Diseases (NIAID), in cooperation
with the Department of Defense, established the COVID-19 Prevention
Network (CoVPN) by leveraging existing NIAID-funded clinical trials
networks, including networks focused on HIV treatment and prevention.
The CoVPN built on existing community relationships to enhance trust
and meaningful engagement in key racial and ethnic minority communities
throughout the United States to promote diverse participation in
clinical trials for COVID-19. The community relationships enhanced by
the CoVPN may be further leveraged to advance efforts, including
testing and surveillance, for HIV and other infectious diseases.
The National Institutes of Health (NIH) also anticipates that the
rapid establishment of COVID-19 testing and surveillance may help to
address HIV and other infectious diseases. NIH launched the Rapid
Acceleration of Diagnostics (RADx) initiative to speed innovation in
technologies to test for severe acute respiratory syndrome coronavirus
2 (SARS-CoV-2), in partnership with the Biomedical Advanced Research
and Development Agency (BARDA), the Centers for Disease Control and
Prevention (CDC), the U.S. Food and Drug Administration (FDA), and the
Defense Advanced Research Projects Agency (DARPA). As part of RADx, NIH
and CDC are evaluating whether frequent self-administered, at-home
SARS-CoV-2 testing helps reduce community transmission of SARS-CoV-2.
Efforts to develop and deploy rapid, point-of- need diagnostics for
SARS-CoV-2--including at-home testing kits--may inform community-based
testing and surveillance strategies for other infectious diseases,
including HIV.
NIH and NIAID will continue to build on investments in improved
diagnostic tests for SARS- CoV-2 to support the development of novel
diagnostic tests for other infectious diseases such as HIV. In
addition, lessons learned on the best way to integrate and expand on
existing research efforts and infrastructure will be invaluable as we
continue to prepare for--and respond to-- other existing and emerging
infectious disease threats.
As discussed in response to part a of this question, the Federal
response to the COVID-19 pandemic has strengthened existing
partnerships and coordination mechanisms, as well as established new
partnerships that will inform the response to future infectious disease
pandemics and existing epidemics, such as the HIV/AIDS epidemic in the
United States. The coordinated efforts through RADx and the CoVPN
allowed us to leverage the intrinsic strengths from public and private
sector partners to achieve an unprecedented level of scientific
achievement and community engagement. When the COVID-19 pandemic ends,
lessons learned from our experiences with RADx and the CoVPN will
continue to help inform efforts to address other infectious disease
threats.
NIH and NIAID will continue to work with HHS Operating Divisions
and other Federal agencies to identify the actions that were most
effective in responding to the COVID-19 pandemic. This information may
result in new initiatives, strategic plans, and/or formal assessments
of pandemic preparedness.
______
Questions Submitted by Senator Richard C. Shelby
Question. As America begins to assist the world to vaccinate all
who want it, the current vaccine options can be problematic for
countries without the infrastructure to store vials in a cooled or
frozen environment.
How beneficial could an effective, intranasal vaccine option be for
developing countries that cannot store the current vaccines at frigid
temperatures or produce the healthcare workers to give the shot?
Do you see this option benefitting Americans who may be hesitant to
receive the current vaccine dosage in a shot?
Answer. Global access to safe, effective vaccines will be critical
to address the coronavirus disease 2019 (COVID-19) pandemic. Limiting
the spread of the severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) virus in foreign countries helps to control the pandemic
in those countries while also limiting the development and spread of
variants that could eventually be introduced into the United States. To
enhance vaccine availability in foreign countries, the Biden
Administration has supported and contributed to COVAX, a global
mechanism for equitable access to COVID-19 vaccines. COVAX has
delivered COVID-19 vaccines to more than 100 countries, the majority of
which have lower-income economies. The United States also has made
millions of doses of COVID-19 vaccines available to other countries to
support vaccination campaigns around the world.
Existing COVID-19 vaccines are being successfully administered
globally, and several COVID-19 vaccines authorized for emergency use or
in clinical testing in the United States can be shipped and stored at
refrigerator temperatures (2-8 degrees Celsius). Still, the development
of vaccines that can be administered with less skill and/or stored at
warmer temperatures have the potential to expand vaccination efforts
both in the United States and abroad. The National Institute of Allergy
and Infectious Diseases (NIAID) is supporting the development of
vaccine candidates and platforms that may be more accessible and
convenient than currently available COVID-19 vaccines, including a
single-dose intranasal SARS-CoV-2 vaccine candidate called ChAd-SARS-
CoV-2-S. NIAID scientists and collaborators recently showed that the
intranasal ChAd-SARS-CoV-2-S vaccine candidate limited infection in
non-human primates. Novel vaccines with alternative administration
strategies, such as intranasal vaccines, may reduce barriers to
transporting and administering vaccines in developing countries. It is
important to note, however, that these vaccines may still need to be
kept at low temperatures or may require administration by a healthcare
provider with specialized training to ensure accurate dosing and
administration. For example, FluMist Quadrivalent--a U.S. Food and Drug
Administration-approved intranasal vaccine against influenza--must be
administered by a healthcare provider in the United States.
In addition, National Institutes of Health (NIH) scientists and
NIH-supported researchers are studying additional vaccine delivery
technologies, including vaccines that can be orally administered or
that utilize microneedles in patches placed on the skin to deliver the
vaccine. For example, NIH scientists have begun preclinical evaluation
of a virus-like-particle-based vaccine candidate for SARS-CoV-2 that
can be administered orally, and NIH-supported researchers are
evaluating a patch-based vaccine for SARS-CoV-2. An NIH-supported Phase
I trial of a patch-based vaccine candidate for influenza showed that
individuals that received the vaccine had a similar immune response to
those receiving the influenza vaccine via intramuscular injection. NIH
also is supporting the development of another promising patch-based
vaccine candidate for influenza that uses biodegradable microneedles
originally developed through NIH-supported research to stabilize
vaccines and antibiotics outside of the cold chain. Although additional
testing will be necessary, orally administered and patch-based vaccines
may prove to be an invaluable tool in resource-limited settings as they
may require little to no refrigeration, as well as less training to
administer correctly.
As we work to address the COVID-19 pandemic, as well as other
infectious disease threats, recent innovations in vaccine technology
will help make it easier to get vaccines to areas that can be difficult
to serve with traditional vaccines. NIH continues to support research
on intranasal, oral, and patch-based vaccine platforms, all of which
could be highly adaptable for use against a number of infectious
pathogens.
Vaccines that can be administered intranasally may be considered
less invasive than those that require an injection. Such an option may
encourage individuals who are hesitant to receive the COVID-19 vaccines
currently authorized for emergency use in the United States, which are
all administered via intramuscular injection, to become vaccinated.
Additional vaccine delivery technologies, such as oral or patch-based
vaccines may also provide additional flexibilities when trying to reach
individuals in resource-limited areas or who are vaccine hesitant or
needle adverse. As noted in the response to part a of this question,
NIAID is supporting and will continue to support the development of
vaccine candidates with different delivery technologies to reduce
vaccine hesitancy as well as barriers to vaccine access.
______
Questions Submitted to Dr. Diana Bianchi and Dr. Eliseo Perez-Stable
Questions Submitted by Senator Richard J. Durbin
Question. Our nation continues to struggle with racial disparities,
especially in maternal health. The U.S. is one of only 13 countries
where our nation's maternal mortality rates are worse now than they
were 25 years ago. Every year, 700 women in the U.S. die as a result of
their pregnancy--and more than 60 percent of these deaths are
preventable. Tragically, African American and Hispanic women are three
times as likely as White women to die from pregnancy-related issues.
For years, I have introduced the MOMMA's Act with Rep. Robin Kelly, and
I'm so pleased that a major component of our bill was recently signed
into law as part of the American Rescue Plan. Now states can follow in
Illinois' footsteps by allowing new moms to keep their Medicaid
coverage for a full year, versus just 60 days.
What research NIH is doing in this space?
How is NIH working to actually improve maternal and infant
healthcare?
Answer. Maternal health is a priority for the National Institutes
of Health (NIH) and multiple NIH institutes have heavily invested in
research to prevent maternal morbidity and mortality (MMM) and improve
health for women, before, during, and after pregnancy. In fiscal year
2020 NIH supported $407 million in research on maternal health and $224
million in research on MMM.
In a year that was dominated by both the coronavirus disease 2019
(COVID-19) pandemic and renewed calls to combat health disparities and
inequities, NIH ensured these challenges were integrated into efforts
to reduce MMM. In March 2020, researchers in the Eunice Kennedy Shriver
National Institute of Child Health and Human Development's (NICHD)
Maternal-Fetal Medicine Units Network designed the Gestational Research
Assessments for COVID-19 (GRAVID) study, which evaluated data from more
than 1,200 pregnant women at 33 hospitals across the country and found
that pregnant COVID-19 patients with severe disease are at higher risk
for cesarean delivery, postpartum hemorrhage, hypertensive disorders of
pregnancy, and preterm birth. Data from the study is being shared with
a larger registry to inform future studies of COVID-19's effects on
pregnancy and maternal health.
Tackling the challenge of reducing maternal MMM requires strong
partnerships with and among local communities and resources,
particularly with racial and ethnic minority populations that
experience stark health disparities. To that end, several NIH
Institutes, Centers, and Offices (ICOs) held community engagement
activities to hear first-hand how patient communities can inform future
research and what engagement strategies might enhance local efforts to
improve maternal health. A common refrain was that research conducted
in a community should be developed with and vetted by the community to
ensure success and improved outcomes. These engagement activities
informed the development of the IMPROVE (Implementing a Maternal health
and PRegnancy Outcomes Vision for Everyone) Initiative, which aims to
build an evidence base that will improve maternal care and outcomes
from pregnancy through 1 year postpartum. IMPROVE is co-led by NICHD
and the NIH Office of Research on Women's Health and engages over 30
ICOs to research the leading causes of maternal mortality in the United
States--cardiovascular disease, infection, and immunity--as well as
contributing health conditions or social factors, such as mental health
disorders, diabetes, obesity, substance use disorders, and structural
and healthcare system issues that disproportionately affect Black
pregnant and postpartum women. IMPROVE prioritizes comprehensive,
interdisciplinary research that engages communities with high rates of
maternal deaths and complications. This work will help create tailored,
evidence-based solutions for pregnant and postpartum women.
NIH research on MMM generates evidence that improves outcomes and
clinical care, and several NIH Institutes have strong investments in
this space. For example, an NICHD-funded study demonstrated that when
hospitals implemented evidence-based recommendations for clinical
practice there was a reduction in the risk of severe maternal morbidity
from obstetric hemorrhage, a common complication of childbirth. The
reduction was more dramatic for Black women more than for White women,
reducing disparities and improving outcomes. NICHD is also supporting a
machine learning framework to predict severe maternal morbidity.
Researchers aim to analyze population-based data from Maryland state
databases and hospital surveys to develop techniques that can predict
maternal risks early. Identifying key predictors of severe maternal
morbidity can help ascertain health disparities, strengths and
weaknesses in obstetric care, and prevent adverse maternal and neonatal
outcomes.
In fiscal year 2020, the National Institute on Minority Health and
Health Disparities (NIMHD) started an initiative entitled Addressing
Racial Disparities in Maternal Mortality. This initiative supports
multidisciplinary research projects that examine the clinical, social,
behavioral, and healthcare system interventions to address racial
disparities in MMM in the United States. Additionally, NIMHD funded the
Maternal and Developmental Risks from Environmental and Social
Stressors (MADRES) project in collaboration with the National Institute
on Environmental Health Sciences, to examine prenatal environmental
exposures and social stressors in relation to depression and
cardiovascular risk factors postpartum.
The National Heart, Lung, and Blood Institute (NHLBI) is weaving
together a network of community-engaged researchers who will not only
work to improve women's heart health and reduce maternal mortality, but
will also address other health disparities. For example, NHLBI's new
Maternal Health Community Implementation Program, will fund three or
four regional coalitions to pilot test community-based strategies in
areas where maternal death rates are high, particularly in the
southeast. Additionally, NHLBI's Early Intervention to Promote
Cardiovascular Health of Mothers and Children (ENRICH) will tap into
existing Federal home health/wellness programs that serve at-risk
families to determine if adding a cardiovascular intervention will
enhance maternal and early childhood outcomes. Approximately 3,000
mother- child pairs across various sites will be reached as part of
this effort.
These are just a few examples of how NIH's broad investment in
addressing MMM is improving maternal and infant care.
______
Questions Submitted by Senator Jeanne Shaheen
Question. I am hopeful that our continued investment in the Special
Diabetes Program, and diabetes research at NIH as a whole, can help
spur a new wave of breakthroughs, and maybe one day a cure for
diabetes.
Now that Congress has secured longer-term funding for the Special
Diabetes Program, can you please provide information on NIH's priority
areas for Special Diabetes Program research in the years to come?
Answer. The National Institutes of Health (NIH) appreciates the
recent extension of the Special Diabetes Program, which will allow us
to continue critical ongoing research programs and to support new
research to improve the health and quality of life of people with or at
risk for type 1 diabetes and its complications. For example, the recent
extension will allow the National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK) to continue the Human Islet Research
Network, which is working to better understand how insulin-producing
cells are lost in type 1 diabetes and to find strategies to replace or
protect them in people, toward curing the disease. NIDDK plans to begin
new clinical trials through the Type 1 Diabetes TrialNet network,
testing agents to prevent onset of clinical type 1 diabetes. Such
research will build on the landmark success of previous TrialNet
research demonstrating for the first time ever that early preventive
treatment can delay onset of clinical type 1 diabetes in high-risk
individuals. NIDDK also plans to support research building on the
tremendous recent progress in developing transformative diabetes
management technologies, such as artificial pancreas devices. For
example, future research is needed to improve components of artificial
pancreas devices (e.g., glucose sensors, hormone formulations), develop
simpler and more user-friendly devices, and test devices in
understudied populations (e.g., older adults, pregnant women, people
with poorly controlled blood glucose levels). This type of research
will move us closer to our goal of developing multiple different
artificial pancreas technologies for people of all ages so that they
can choose the technology best suited to their clinical needs. NIDDK
also plans to support new research to identify novel ways to detect and
monitor type 1 diabetes onset and progression, such as by determining
whether ``extracellular vesicles'' that originate from pancreatic
tissue may be useful to detect earlier stages of type 1 diabetes than
currently possible. NIDDK is collaborating with the National Heart,
Lung, and Blood Institute on new research toward reducing
cardiovascular disease in people with type 1 diabetes, as very little
is known about how best to prevent and treat this life-threatening
complication. To inform other future research directions, NIDDK is
spearheading a planning meeting in spring 2022 under the auspices of
the statutory Diabetes Mellitus Interagency Coordinating Committee to
obtain input from external scientific and lay experts on critical new
and emerging research opportunities that could be supported by the
Special Diabetes Program.
Question. New Hampshire continues to be one of the hardest-hit
states in the substance use disorder epidemic, with one of the highest
overdose death rates in the country. I am very supportive of the
ongoing work at the National Institute on Drug Abuse (NIDA) to research
potential non-addictive alternatives to opioids for pain management.
Could you discuss progress on any research within NIDA to study
these types of alternatives?
Answer. The National Institutes of Health (NIH) recognizes the need
to improve pain management without risk of addiction and other serious
side effects. NIH is taking a multi-pronged approach to develop safe
and effective therapies to reduce our reliance on opioids.
To avoid replay of the spike in opioid deaths related to over-use
of medical opioids for pain management we need more effective, non-
addictive pain medications and data that can inform best practices in
pain care. The NIH Helping to End Addiction Long-term (HEAL) Initiative
was launched in 2018 and significantly expanded research to discover
and accelerate development of non-addictive pharmacological and non-
pharmacological pain treatments. HEAL has awarded over $1.5 billion for
research to improve pain management and address opioid use disorder and
overdose. Studies supported by HEAL, the Blueprint Neurotherapeutics
Program, and multiple NIH Institutes, in particular the National
Institute for Neurological Disorders and Stroke (NINDS), are underway
to identify, optimize and test promising molecules, biologics, and
devices that target non-opioid pain pathways in the nervous system.
Biomarker studies to help with diagnosis of pain conditions and to
identify patients most likely to respond to a particular treatment will
enhance pain clinical trials and improve best practices are moving
forward. In addition, non-pharmacological approaches to manage many
different pain conditions are being evaluated through effectiveness and
implementation research approaches.
The NIH HEAL initiative established essential pain research
infrastructure to accelerate development of new medications and devices
to treat pain. An analgesic screening platform uses animal- and human
cell-based models such as neural tissue chips for rapid screening of
molecules or devices for analgesic relevant biological and pain
behavioral activity. HEAL, with input from academic and industry
partners, established an Early Phase Pain Investigation Clinical
research network (phase 2 studies) to test safety and efficacy of novel
therapeutics and a later stage pain management Effectiveness Research
Network (ERN) to compare effectiveness of pharmacological and non-
pharmacological approaches in many different pain conditions. The ERN
is supporting eight large trials for various pain management
strategies. The Pragmatic and Implementation Studies for the Management
of Pain to Reduce Opioid Prescribing (PRISM) network focuses on
clinical trials of non-pharmacologic pain therapies in healthcare
systems.
The Phase 2 network will launch trials on two new analgesics in
2021. The ERN is supporting eight large trials for various pain
management strategies. PRISM is supporting six large trials in
healthcare systems. In addition, HEAL established an analgesic
development pipeline to accelerate the development and testing of novel
drugs and devices. This program uses team-based science coupled with a
comprehensive set of research resources to bring new therapeutics
rapidly to the clinic. To advance the discovery and validation of new
drug targets, HEAL has funded over 30 projects to discover and verify a
diverse set of drug target types across multiple pain conditions, six
drug optimization studies on new safe and effective pain treatments,
and 11 projects to test the effectiveness of implanted devices and
noninvasive stimulation of nerves in the brain or throughout the body
to reduce perception of pain. This effort greatly expands on NINDS
supported studies in these areas.
Recent HEAL accomplishments toward new therapeutics include two
patent filings for small molecule modulators of pain receptors involved
in chronic pain and migraine. One ongoing study received
Investigational New Drug (IND) approval for use of buprenorphine with
nonpharmacological treatment to relieve pain in patients undergoing
kidney dialysis. Through the NIH Blueprint Neurotherapeutics Program
researchers are developing non-addictive kappa opioid receptor
antagonists for treatment of migraine and a safe, non-opioid epoxide
hydrolase inhibitor to reduce diabetic nerve pain. Earlier, NIH
supported basic science research led to calcitonin gene-related peptide
therapy for migraine and nerve growth factor therapy for inflammatory
pain. Drugs that target these molecules are now approved by the U.S.
Food and Drug Administration to treat migraine and osteoarthritis pain.
Through the Brain Research through Advancing Innovative
Neurotechnologies (BRAIN) Initiative, which is a major effort to
develop tools to map, monitor, and modulate neural circuits, NIH has
supported studies that will enhance diagnostics and therapies for
chronic pain and other neural circuit disorders.
Question. The Institutional Development Award (IDeA) program at NIH
has proven critical in funding New Hampshire researchers, including
especially the innovative work at Dartmouth College and Dartmouth-
Hitchcock Health. I am hopeful that Congress can continue to support
funding for this program.
Can you provide any insight into how NIH is currently making use of
Institutional Development Award funds and whether more funding for the
program would be helpful?
Answer. The Institutional Development Award (IDeA) supports basic,
clinical, and translational research, faculty development, and
infrastructure improvements at institutions in states and territories
that have historically received a lower aggregate level of NIH funding.
The program aims to strengthen biomedical research capacity, enhance
the competitiveness of investigators in securing research funding, and
enable clinical and translational research that addresses the specific
needs of rural and medically underserved communities. Currently,
institutions in 23 States and Puerto Rico are eligible for funding
through the IDeA Program, the various components of which include:
--IDeA Networks of Biomedical Research Excellence (INBRE). INBRE
enhances, extends, and strengthens the research capabilities of
biomedical research faculty in IDeA states through a statewide
program that links a research-intensive institution with
primarily undergraduate institutions. INBRE supports
institutional research and infrastructure development; research
by faculty, postdoctoral scientists, and students at
participating institutions; and targeted outreach to build
science and technology knowledge within a state's workforce.
Only one INBRE award is made per IDeA-eligible state. The New
Hampshire INBRE, which is led by Dartmouth and co-led by the
University of New Hampshire, is in its twelfth year of
operation and has used the program's support to improve and
expand research capacity at all eight of its partner
institutions, including adding additional labs, cores and
instrumentation/infrastructure; establishing fully functional
Office of Sponsored Programs for faculty members to
competitively seek extramural grants; training and mentoring of
both faculty and students; and enhancing a vibrant
institutional research culture. In fiscal year 2020, the
National Institute of General Medical Sciences (NIGMS)
supported 24 INBRE awards.
--Centers of Biomedical Research Excellence (COBRE--Phases I, II, and
III). COBRE supports the establishment and development of
innovative, state-of-the-art biomedical and behavioral research
centers at institutions in IDeA-eligible states that: (a)
galvanize multidisciplinary research to develop a critical mass
of investigators that are competitive for peer-reviewed
research funding; (b) provide improvements to research
infrastructure; and (c) maintain research cores to sustain a
collaborative, multidisciplinary research environment that
includes pilot project programs, mentoring, and workforce
training. In fiscal year 2020, NIGMS supported 112 COBRE
awards. One such example, a Phase I COBRE at Dartmouth's Geisel
School of Medicine called iTarget (Institute for Biomolecular
Targeting), aims to catalyze the development of new therapeutic
approaches to address cancer, chronic obstructive pulmonary
disease, and respiratory syncytial virus, a common viral
infection that can be dangerous to young children and the
elderly. This COBRE is providing unique resources to
investigators at Dartmouth and its IDeA partners, thus
enhancing research productivity and funding competitiveness
across the region.
--IDeA Networks for Clinical and Translational Research (IDeA-CTR).
IDeA-CTRs develop a network infrastructure and capacity in
IDeA-eligible states to conduct clinical and translational
research focused on health concerns that disproportionately
affect rural and medically underserved populations and/or that
are prevalent in IDeA states. IDeA-CTR awards support mentoring
and career development activities in clinical and translational
research. In fiscal year 2020, NIGMS supported 12 IDeA-CTR
awards.
--Regional Technology Transfer Accelerator Hubs. NIGMS established
the Regional Technology Transfer Accelerator Hubs for IDeA
states in each of the four IDeA regions (central, northeast,
southeast, and western regions). The hubs provide both
consulting services and skills development in entrepreneurship,
technology transfer, small business finance, and other areas
needed to transform important discoveries made in the
laboratory into potentially viable commercial products that
address human health. In fiscal year 2020, NIGMS supported four
accelerator hubs. The northeast hub is located at Celdara
Medical in Lebanon, New Hampshire.
--Research Co-Funding. NIGMS provides co-funding for applications
from IDeA state institutions that have been judged meritorious
by NIH peer-review committees and national advisory councils
but that may also fall outside the usual range of support by a
given NIH Institute or Center (IC). In fiscal year 2020, NIGMS
co-funded 42 research project grants at 20 NIH ICs; one of
these was at Dartmouth College.
______
Questions Submitted to Dr. Ned Sharpless
Questions Submitted by Senator Patty Murray
Question. The American Cancer Society's Annual Report to the Nation
on the Status of Cancer highlighted that we are making good progress in
the battle against cancer, with the incidence and mortality rates for
most cancers have dropped significantly. However, among the 20 most
common cancers, relative survival for patients significantly improved
since the mid-1970s except for those with uterine cancer.
What plans does the NCI have in fiscal year 2022 to develop a
paradigm of increased research to improve hope for survival for
patients with uterine cancer?
Answer. The National Cancer Institute (NCI) shares the committee's
commitment to research on uterine cancers, including endometrial cancer
(cancer of the inner lining of the uterus), and improving outcomes for
patients.
Today, nearly 40 percent of adults are obese, and without
intervention, the obesity epidemic will result in more cancers. Uterine
cancer incidence and mortality have increased in recent years,\40\
believed to be partially associated with rising rates of obesity.\41\
Women who are obese or overweight are approximately two to four times
as likely as normal weight women to develop uterine cancer, including
endometrial cancer, making interventions to address weight and obesity
vital to combatting uterine cancer incidence and mortality. Examples of
NCI-supported research on this topic include a study of how changes in
body composition following weight loss impact inflammatory biomarkers
in biopsy-collected endometrial tissue and blood samples and whether
these processes differ between Black and White women; \42\ the
development of a weight loss intervention among Appalachian residents;
\43\ and a study of the Deep South Interactive Voice Response (IVR)-
supported Active Lifestyle (DIAL) Intervention to increase physical
activity levels among residents of the Deep South.\44\
---------------------------------------------------------------------------
\40\ pubmed.ncbi.nlm.nih.gov/30521505/,seer.cancer.gov/
report_to_nation/statistics.html#
factors.
\41\ www.cancer.gov/about-cancer/causes-prevention/risk/obesity/
obesity-fact-sheet.
\42\ reporter.nih.gov/project-details/10129305.
\43\ reporter.nih.gov/project-details/10065366.
\44\ reporter.nih.gov/project-details/10163139.
---------------------------------------------------------------------------
Researchers at the University of North Carolina Lineberger
Comprehensive Cancer Center are directly examining the metabolic and
molecular differences of endometrial tumors in obese and non-obese
women. In addition, this research team is exploring how metformin,
widely used to treat type II diabetes, may also exhibit anti-tumor
activity through its effects on a patient's metabolism.\45\
---------------------------------------------------------------------------
\45\ reporter.nih.gov/project-details/10104456.
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Translational research to bridge the gap between basic research on
endometrial cancer and potential therapies is also essential to
improving outcomes for patients. NCI supports a Specialized Program of
Research Excellence (SPORE) focused on translational research for
endometrial cancer at the University of Texas/MD Anderson Cancer
Center. This SPORE is conducting research aimed at developing
therapeutic strategies for advanced/recurrent endometrial cancer and
aggressive subtypes, addressing unmet clinical needs in prevention and
conservative therapy of high-risk precancerous lesions and low-grade
endometrial cancer, and incorporating molecular diagnostics into
clinical decisionmaking.\46\
---------------------------------------------------------------------------
\46\ trp.cancer.gov/spores/endometrial.htm.
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As of July 2021, NCI is supporting over 150 clinical trials with a
primary focus on uterine (including endometrial) cancer. Examples of
these projects include studies of the use of an immunotherapy agent, in
combination with other cancer therapies, to treat high risk endometrial
cancer; \47,48\ a trial examining a combination therapy to treat
endometrial cancers that express the HER2 protein; \49\ and a study
evaluating the use of the experimental therapy triapine to treat
endometrial serous adenocarcinoma, a difficult to treat subtype of
uterine cancer.\50\ Clinical trials are an integral part of advancing
research in this important topic area, and NCI is committed to reaching
out to disparate, at-risk communities to explain, educate, and
encourage clinical trial participation.
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\47\ clinicaltrials.gov/ct2/show/NCT04214067.
\48\ clinicaltrials.gov/ct2/show/NCT03914612.
\49\ clinicaltrials.gov/ct2/show/NCT04585958.
\50\ clinicaltrials.gov/ct2/show/NCT04494113.
---------------------------------------------------------------------------
As part of the National Institutes of Health (NIH) efforts to
identify future research directions, NCI and the Eunice Kennedy Shriver
National Institute of Child Health and Human Development (NICHD)
explored research opportunities into the progression of benign
gynecologic conditions to cancers through a collaborative workshop in
April 2019. Currently, NICHD funds research on benign gynecologic
conditions such as endometriosis and uterine fibroids, while NCI funds
research on women's cancers. The workshop sought to bridge the two
research areas and identify gaps in the biologic, epidemiologic, and
clinical understanding of progression from benign conditions to cancer.
The workshop addressed three gynecologic disease types: (1)
endometriosis or endometrial cancer and endometrial-associated ovarian
cancer, (2) uterine fibroids (leiomyoma) or leiomyosarcoma, and (3)
denomyosis or adenocarcinoma. Working groups were formed for each
disease type, and key questions and current challenges that emerged
from the discussions, along with potential research opportunities to
advance understanding of progression of gynecologic benign conditions
to cancer, were published. Specific research questions and gaps were
identified in all three focus areas, and several cross-cutting topics
emerged. The results of this workshop, as well as ongoing horizon-
scanning activities, will continue to inform NIH's next steps to
address uterine cancer.
Question. Non-Hispanic Black women are two time as likely as non-
Hispanic White women to die from uterine or cervical cancer (https://
www.ajog.org/article/S0002-9378(16)46212- 5/pdf).
Can NIH/NCI please share with the Committee the research activities
the NCI is supporting to address this disparity, particularly with
regards to access to care, prevention, early diagnosis, treatment
completion and developmental therapeutics?
Answer. The National Cancer Institute (NCI) shares the Committee's
concern regarding cervical and uterine/endometrial cancer disparities
and is working to support research to eliminate these disparities, as
well as cancer disparities more broadly. Examples of research aimed at
addressing disparities in uterine and cervical cancer outcomes are
provided below.
NCI is a leader in developing and supporting definitive, practice-
changing gynecologic (GYN) clinical trials, as well as responding to
areas of scientific inquiry that are unaddressed by private industry.
The NCI GYN Cancers Steering Committee sets clinical trials strategic
priorities that address areas of unmet clinical need, important
unanswered clinical questions, and potential new approaches to disease
treatment.\51\ The Institute has supported and advanced GYN cancer
research that will provide greater insight into these cancers,
additional options for drug therapies, and improved surgical techniques
with the intent of increasing survivorship and quality of life. As of
July 2021, NCI is supporting over 150 interventional clinical trials
with a primary focus on uterine (including endometrial) cancer, two
trials on the rare uterine sarcoma, and nearly 100 trials for cervical
cancer patients. NCI also has several trials that are ``disease
agnostic,'' meaning that they are open to patients with certain genetic
alterations rather than traditional cancer types, creating
opportunities for patients to potentially benefit from precision
medicine and targeted therapy.
---------------------------------------------------------------------------
\51\ www.cancer.gov/about-nci/organization/ccct/steering-
committees/nctn/gynecologic.
---------------------------------------------------------------------------
A recent study led by NCI intramural researchers used population
data from NCI's Surveillance, Epidemiology, and End Results (SEER)
database to evaluate trends of hysterectomy-corrected uterine cancer
incidence rates for women overall and by race and ethnicity, geographic
region, and histologic subtype. Correct estimation of these rates
requires accounting for hysterectomy prevalence, which varies by race,
ethnicity, and region. The researchers found that incidence rates of
common subtypes of uterine cancer were stable in non-Hispanic White
women over the study period and increased in women of other racial/
ethnic groups. By contrast, incidence rates of aggressive subtypes have
been increasing dramatically over time in all racial/ethnic groups; in
particular, much higher rates of these aggressive subtypes were
observed in Black women than in other racial/ethnic groups. The
researchers also observed that survival rates were lower among all
women with aggressive subtypes than among women with common subtypes,
and Black women had the lowest survival rates within each stage at
diagnosis or histologic subtype.
Uterine serous carcinoma (USC) is a rare but aggressive type of
endometrial cancer. In about one-third of women with USC, their tumor
cells overproduce a protein called HER2 (human epidermal growth factor
receptor 2), which is associated with poor prognosis in women with
endometrial cancer. Black women with endometrial cancer are more likely
than White women to be diagnosed with UCS and are more likely than
women of other races/ethnicities to have HER2 overproducing UCS tumors.
NCI clinical studies for patients with HER2 overproducing uterine
serous cancer and carcinosarcoma are currently in development.
NCI-supported researchers are working to describe additional
differences in subtypes of uterine and endometrial cancers, with the
eventual goal of targeting therapies to treat each disease subtype. For
example, investigators at Brigham and Women's Hospital, using data from
the NCI-supported Epidemiology of Endometrial Cancer Consortium
(E2C2),\52\ are studying genomic variation across the full spectrum of
endometrial tumors, distinct risk factor profiles across tumor types,
and the role of underlying tumor biology to better understand the
disparities in outcomes between African-American and non-African-
American women.\53\ NCI-supported investigators at Wayne State
University are examining aggressive subtypes of high-grade endometrial
tumors, including endometrioid, serous, clear cell and mixed
carcinomas, by analyzing both clinical and genetic data in 500 women
(250 African-American, 250 White) diagnosed with these cancers.\54\ In
addition, NCI is supporting a planning grant to establish a Specialized
Program of Research Excellence (SPORE) at Northwestern University
focused on gynecologic cancer disparities. One of the pilot projects
will focus on the tumor genomics of endometrial cancer.\55\
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\52\ epi.grants.cancer.gov/eecc/.
\53\ reporter.nih.gov/search/o5KPkwNzZUavBogOfHXfCgproject-details/
10156374.
\54\ reporter.nih.gov/search/frdhnx_EQkONjxE8GPyxvQ/project-
details/9916725.
\55\ reporter.nih.gov/search/-UP_KUgEu0G9_0Zt655Nsg/project-
details/9961257.
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To more accurately evaluate the risk of cervical precancer and
study novel biomarkers in women undergoing cervical cancer screening,
intramural researchers in NCI's Division of Cancer Epidemiology and
Genetics have partnered with the University of Mississippi Medical
Center and the Mississippi State Department of Health in the STRIDES
Study (Studying Risks to Improve Disparities of cervical cancer in
Mississippi). This study, based in one of the top five states for
cervical cancer incidence and mortality, combines the expertise of
clinicians, laboratory scientists, epidemiologists, and implementation
scientists to address all aspects of cervical cancer prevention and
control.\56\
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\56\ dceg.cancer.gov/research/cancer-types/cervix/cervix-
mississippi.
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In 2020, NCI launched the ``Last Mile Initiative,'' with the goal
of improving cervical cancer screening coverage to underserved, never
screened, and under-screened women. This initiative will evaluate an
alternative cervical cancer screening approach: self-collection of
samples (self- sampling) by women, which are then sent to labs for
human papillomavirus (HPV) testing. This approach aims to identify
cervical cancer cases in these groups of women, which account for over
half of cervical cancer cases in the United States each year. Self-
sampling offers several benefits, including ease of collection at the
time and place of the patient's choosing, without the need for a clinic
appointment or speculum exam. To conduct this assessment, NCI
established a public-private partnership between Federal agencies,
industry partners, and professional societies/clinical guidelines
organizations, and will support a nationwide, multicentric screening
trial in diverse settings, the Last Mile Initiative Self-sampling for
HPV Testing to Improve Cervical Cancer Prevention Trial (LMI-SHIP
Trial).\57\
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\57\ prevention.cancer.gov/major-programs/nci-cervical-cancer-last-
mile-initiative.
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Additionally, NCI is collaborating with the NIH Office of Research
on Women's Health (ORWH) and other NIH Institutes and Centers to
participate in an ORWH Advisory Committee on Research on Women's Health
Consensus Conference to be held in October 2021. The conference will
include a focus on cervical cancer disparities and research
opportunities to continue to address disparities in incidence and
mortality.
NCI will continue to identify opportunities to better understand
and address cancer health disparities, including for cervical and
uterine/endometrial cancers.
______
Questions Submitted by Senator Richard J. Durbin
Question. Approximately 20,000 people in the United States have
germline mutations in the gene RUNX1. Patients with RUNX1-familial
platelet disorder are at a heightened risk for developing blood
cancers. NCI supports a longitudinal natural history study of patients
with such germline mutations and their families. While germline RUNX1
mutations are rare, I understand that NIH-funded research in this area
holds promise for the fields of hematology and oncology.
How can deepening our understanding of, and ultimately developing
cancer prevention strategies for, inherited blood cancer predisposition
syndromes like RUNX1 familiar platelet disorder advance the entire
cancer research field forward?
Answer. The RUNX1 gene regulates the development of blood cells
(hematopoiesis), controlling other genes that help determine the fate
of hematopoietic stem cells, which have the potential to develop into
all types of mature blood cells, including platelets. Platelets are
cells that help blood to clot. Inherited mutations in the RUNX1 gene
cause familial platelet disorder with associated myeloid malignancies
(RUNX1-FPDMM) and predispose individuals to some types of blood
cancers. Although genetic predisposition to solid tumors such as breast
and colon cancers has been widely recognized over the past several
decades, the contribution of inherited genetic disorders related to
blood cancer is a more recent field of study.
There are many instances where understanding the molecular basis
for a rare inherited disease has provided insight into more common
forms of a particular disease. For example, BRCA1 and BRCA2 mutations
were discovered as hereditary breast cancer genes but are also relevant
to sporadic (non-hereditary) breast cancers, ovarian cancers, and some
hereditary forms of colon cancer. Similarly, understanding the blood
cancers associated with RUNX1-FPDMM may lead to improved understanding
of other types of blood cancers as well.
Research efforts across the National Institutes of Health (NIH) are
underway to better understand RUNX1-FPDMM. Investigators funded by the
National Heart, Lung, and Blood Institute (NHLBI) are studying cells
from people with this disorder to better understand key target genes
regulated by RUNX1 and their role in hematopoiesis.\58\ This work could
also yield a better understanding of genetic pathways that lead to
blood cancers, as well as the blood clotting mechanisms that contribute
to cardiovascular disease. Investigators at the National Human Genome
Research Institute (NHGRI), along with intramural scientists at the
National Cancer Institute (NCI), are conducting a natural history study
at the NIH Clinical Center that is intended to identify and follow
patients with RUNX1 mutations to hopefully identify biomarkers that can
predict which patients will develop cancers.\59\ To date, the study has
enrolled 198 patients from 55 families, representing the largest FPDMM
cohort being followed prospectively at a single institution in the
world.
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\58\ reporter.nih.gov/project-details/10083753.
\59\ www.genome.gov/Current-NHGRI-Clinical-Studies/hematologic-and-
premalignant-conditions-associated-with-RUNX1-
mutation;clinicalstudies.info.nih.gov/ProtocolDetails.
aspx?id=2019-HG-0059; clinicaltrials.gov/ct2/show/NCT03854318.
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Studying RUNX1-FPDMM will have broader significance than just this
rare disease. Germline (inherited) predisposition to hematopoietic
malignancies is often under-diagnosed, with recent studies indicating
that 10-30 percent of RUNX1 mutations detected in acute myeloid
leukemias are inherited, which is much more common than previously
appreciated.\60\ In addition, FPDMM can serve as a model to study the
development of leukemia, since researchers can monitor individuals with
the RUNX1 mutation before they develop leukemia to identify factors
associated with cancer risk and to map tumor evolution.
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\60\ pubmed.ncbi.nlm.nih.gov/32315381/.
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______
Questions Submitted by Senator Jack Reed
Question. The fiscal year 2021 Appropriations law included full
funding--$30 million--for the Childhood Cancer STAR Act, which I
authored.
Could you provide an update on how that funding will be spent in
the coming year?
How will that work be coordinated with the childhood cancer data
initiative?
Answer. NCI is supporting several new and ongoing Childhood Cancer
STAR Act research projects in fiscal year 2021, for a total planned
investment of $28 million. The Centers for Disease Control and
Prevention continues to support enhancements to expand capacity within
the National Program of Cancer Registries (NPCR) to help cancer
registries collect and make the data on pediatric cancer cases
available more rapidly, a $2 million effort in fiscal year 2021.
Consistent with provisions in Section 101 of the STAR Act, NCI's
fiscal year 2021 appropriation for STAR Act activities is supporting
new and expanded projects focused on the collection and storage of
biospecimens for future research. Several projects are conducted
through the NCI-supported Children's Oncology Group (COG) to focus
additional attention to rare cancer subtypes that are currently
underrepresented in NCI-supported biorepositories, as well as tumor
types with a high risk of treatment failure. For example, particularly
rare subtypes of pediatric cancers for which COG does not have open
clinical trials, tumor tissue collection options are limited. STAR Act
appropriations are supporting the COG Rare and Under-Represented Cancer
Tissue Banking project to enable tumor tissue and associated germline
(e.g., blood) sample collection for specific groups of patients for
which current tumor tissue collection is lacking or inadequate, with
priority for tumor types such as sarcomas and brain and central nervous
system (CNS) tumors, which have high risk of treatment failure.
The COG Rare and Under-Represented Cancer Tissue Banking project
was launched in fiscal year 2020 and is expanding in scope in fiscal
year 2021. This initiative is collaborating closely with CCDI, and with
the use of fiscal year 2021 CCDI funds, tumor tissue will undergo
clinically-relevant molecular profiling through the CCDI Molecular
Characterization Protocol. The data generated will be returned to
treating physicians to help guide the diagnosis and treatment of
patients, and the data will additionally be stored and made available
to the research community through CCDI data platforms. In addition to
rare cancer populations, the CCDI Molecular Characterization Protocol
will initially support characterization of tumors from children with
CNS tumors and from children with soft tissue sarcomas. The Protocol
aims to collect, store, and make available detailed clinical and
molecular information for each child participating in the study,
including data that will help a pediatric oncologist treat that patient
and help researchers learn more about childhood cancers.
NCI is continuing support in fiscal year 2021 for other STAR Act
biobanking projects launched in fiscal year 2020. Through the COG Rapid
Autopsy Specimen Collection project, NCI and COG are working with
patient organizations to support rapid autopsy collection of tumor
samples from children and adolescents and young adults (AYAs) who have
died of their disease. Foundations and families within the pediatric
brain tumor community have been leaders in such programs, and NCI
continues to learn from their experiences to expand this model to other
childhood cancers. We are incredibly grateful to these parents and
caregivers, who amidst unimaginable grief and loss, contribute to
future research to advance science and help other families.
NCI is also supporting the COG to continue to expand the collection
of specimens taken at the time of relapse, as well as collecting
diagnostic samples for children and AYAs who have already submitted
samples at relapse through NCI's Pediatric Molecular Analysis for
Therapy and Choice (MATCH) Precision Medicine Trial. An important
impediment to understanding mechanisms of treatment failure for
childhood solid tumors is the limited numbers of paired specimens from
both diagnosis and relapse that are available for researchers to study.
Specimens at relapse are critical for evaluating biological changes
between diagnosis and relapse that can lead to the identification of
mechanisms of treatment failure and to the development of strategies
for circumventing these mechanisms. Through CCDI, Pediatric MATCH tumor
specimens from diagnosis and from relapse are being molecularly
characterized to identify the changes in gene mutations and gene
expression that occur between diagnosis and relapse, which could inform
better treatments.
Consistent with Section 202 of the STAR Act, in fiscal year 2021,
NCI will continue to conduct and support childhood cancer survivorship
research. NCI has supported two new Requests for Applications (RFAs)
since fiscal year 2019 that are directly aligned with survivorship
research areas emphasized in the STAR Act. Issued in fiscal year 2019,
RFA CA-19-033: \61\ Improving Outcomes for Pediatric, Adolescent and
Young Adult Cancer Survivors focused on projects to develop and test
interventions that prevent, mitigate or manage adverse outcomes in
pediatric and/or AYA cancer survivors and/or evaluate models of care
that strengthen coordination, continuity, and quality, or that reduce
access barriers to needed services including follow-up care, and that
improve outcomes across the survivor's lifespan. Development of
interventions to address disparities in outcomes and/or access to
needed care, and to address the needs of minority or medically
underserved pediatric and/or AYA populations were also prioritized. NCI
is supporting seven awards in response to this RFA, and the awards will
focus on various patient sub-populations (e.g. disease site),
developmental groups, specific late and long-term effects, and the
types of interventions (both preventive and supportive care).
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\61\ grants.nih.gov/grants/guide/rfa-files/RFA-ca-19-033.html.
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Issued in fiscal year 2020, RFA CA-20-027 \62\ and RFA CA-20-028:
\63\ Research to Reduce Morbidity and Improve Care for Pediatric, and
Adolescent and Young Adult (AYA) Cancer Survivors invite applications
for research projects to improve care and health-related quality of
life for childhood and AYA cancer survivors, with a focus on six key
domains that align with research priorities emphasized in the STAR Act:
(1) disparities in survivor outcomes; (2) barriers to follow-up care
(e.g. access, adherence); (3) impact of familial, socioeconomic, and
other environmental factors on survivor outcomes; (4) indicators for
long-term follow-up needs related to risk for late effects, recurrence,
and subsequent cancers; (5) risk factors and predictors of late/long-
term effects of cancer treatment; and (6) development of targeted
interventions to reduce the burden of cancer for pediatric/AYA
survivors.
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\62\ grants.nih.gov/grants/guide/rfa-files/RFA-CA-20-027.html.
\63\ grants.nih.gov/grants/guide/rfa-files/rfa-ca-20-028.html.
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In fiscal year 2021, NCI will support subsequent years for grants
initially awarded in fiscal year 2019 and fiscal year 2020, as awards
were made for five-year terms, and the Institute will be making several
new grant awards through the RFA launched in fiscal year 2020. The
first round of applications is in the final stages of review, and
awards will be made before the close of fiscal year 2021. The second
round of applications are due on July 30, 2021, and awards are
anticipated to be made in fiscal year 2022.
NCI also continues to make additional investments in childhood
cancer survivorship research beyond the STAR Act appropriation, funding
several notable initiatives and projects with resources provided
through the Institute's general appropriation. For example, NCI
continues to fund long-standing investments in the Childhood Cancer
Survivor Study (CCSS),\64\ which the Institute has supported
continuously since establishing CCSS in 1994. This cohort of more than
38,000 childhood cancer survivors diagnosed between 1970 and 1999 (and
5,000 siblings of survivors who serve as the comparison group for the
study) serves as a foundational resource for the survivorship research
community.
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\64\ cancer.gov/types/childhood-cancers/ccss.
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Additionally, NCI continues to support research projects that
investigators develop and submit independent of specific childhood and
AYA cancer survivorship funding opportunities such as the STAR Act RFAs
described above. These investigator-initiated research projects provide
critical contributions to this field, and awards made to date in fiscal
year 2021 include a project to compare symptom burdens (toxicity),
neurocognitive change, and functional outcomes in children with
pediatric brain tumors treated with proton versus photon radiotherapy.
Proton beam radiotherapy (PBRT) is often thought to be a promising
treatment for children with brain tumors as it may preserve cognitive
functioning without sacrificing disease control. This will be the first
large-scale study to prospectively compare the two therapies to assess
important measures of daily functioning that will quantify the clinical
significance of any differences identified between groups in
survivorship. This project aims to help physicians and families better
understand the relative effect of PBRT on symptoms and neurocognitive
functioning to inform treatment decisions.\65\ Another award is
supporting further study of psychosocial risk in young survivors of
pediatric cancer diagnosed in early childhood, including the role of
both physical and neurocognitive late effects. This project aims to
identify specific medical and neurocognitive late effects that increase
psychosocial morbidity, as well as protective factors, to inform more
effective interventions to optimize quality of life in children
affected by cancers diagnosed in early childhood.\66\ In addition, the
NCI-supported ASPIRES (Activating cancer Survivors and their Primary
care providers to Increase coloREctal cancer Screening) study aims to
prevent the development of subsequent cancers among childhood cancer
survivors treated with abdominal or pelvic radiotherapy, who are almost
four times more likely to develop colorectal cancer (CRC) compared to
the general population. The study will test a remote intervention aimed
at promoting early CRC screening and detection.\67\
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\65\ reporter.nih.gov/search/kPIDddsyREmcoShhVEYN4Q/project-
details/10146799.
\66\ reporter.nih.gov/search/5Nb7PgFn7kyHJnjYOFzMQA/project-
details/10122486.
\67\ reporter.nih.gov/search/5Nb7PgFn7kyHJnjYOFzMQA/project-
details/10096080.
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NCI remains committed to implementing the research sections of the
STAR Act directed toward the Institute, and to ensuring that these
efforts continue to complement the Institute's broader portfolio of
childhood and AYA cancer research. This includes CCDI, the COG, the
CCSS, and many other research programs and projects working together to
support much needed progress for children with cancer and their
families, including survivors and caregivers facing the challenges of
managing the late effects of cancer and its treatments.
______
Questions Submitted by Senator Roy Blunt
Question. Dr. Sharpless, one of the goals I had when I was Chairman
of this Subcommittee was to increase NIH funding, in an effort to
increase the success rates of grants--meaning more research grants
would be funded. This is important because the NIH peer review system
does not always reward high-risk science or young researchers' grant
applications. But, if you have additional funding, you can fund more
than just the `safest' science grants from the most established
researchers. NCI has seen an increase of more than 50 percent in the
number of grant applications since 2013, keeping your success rates and
paylines lower than most NIH Institutes. While the positive aspect of
this statistic is that the cancer research community is energized and
applying for NCI funding, you can only fund a certain amount of
applications because of the significant increase in grant applications.
The last two LHHS bills have included specific funding for NCI to
increase their Research Project Grants.
How has this allowed you to increase success rates, raise the
payline, and make more awards?
Answer. The intense competition and demand for NCI funding reflects
incredible scientific opportunities in cancer research and presents a
major challenge for the NCI to carefully balance increasing demand for
competing grant funding while sustaining previous years' commitments to
multi-year grants.
Investigator-initiated research has proven itself to be one of the
biggest drivers of progress in cancer research, and accordingly is the
biggest driver of NCI's budget, with long-term investments into funding
new and continuing awards constituting more than 40 percent of NCI's
annual budget. These awards have been the source of some of the most
innovative and transformative ideas in cancer research, leading to
direct benefits for patients in the form of new oncology drug
approvals, the development of immune checkpoint inhibitor therapy
(Nobel Laureate Jim Allison), CAR-T (chimeric antigen receptor-T) cell
immunotherapy (Carl June), and novel drug design strategies such as
PROTACs (proteolysis targeting chimeras) \68\ that use normal cellular
processes to identify and destroy proteins in cancer cells that drive
cancer growth (Raymond DeShais and Craig Crews).
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\68\ www.cancer.gov/research/annual-plan/scientific-topics/protac-
infographic.
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Considering all funding mechanisms, NCI supported 109 additional
awards in fiscal year 2020 as compared to fiscal year 2019 (from 6,053
in fiscal year 2019 \69\ to 6,162 in fiscal year 2020 \70\). Across
fiscal year 2020 and 2021, the successive funding increases allowed NCI
to increase the R01 payline from the 8th percentile in fiscal year 2019
to the 11th percentile in fiscal year 2021. With the fiscal year 2020
budget increase, NCI increased R01 paylines by 25 percent compared to
fiscal year 2019 and restored continuing grants to 100 percent of their
committed level, providing researchers the full fiscal year 2020 budget
approved during the initial grant award. Funding increases in fiscal
year 2021 allowed NCI to further raise the payline for R01 research
awards, for an overall 35 percent increase compared to 2019, as well as
to keep funding continuing awards at 100 percent. In addition, for
those two consecutive years (fiscal year 2020 and fiscal year 2021),
NCI also raised the payline for Early-Stage Investigators, reflecting
NCI's commitment to developing and supporting early career scientists
to build the next generation of cancer researchers.
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\69\ www.cancer.gov/about-nci/budget/congressional-justification/
fy2021-nci-congressional-justification.pdf.
\70\ www.cancer.gov/about-nci/budget/congressional-justification/
fy2022-nci-congressional-justification.pdf.
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We have the final success rate and total number of awards results
for fiscal year 2020, the year when Congress targeted an additional
$212.5 million for new and continuing grants, but we will not have
final results for fiscal year 2021 until after the first quarter of
fiscal year 2022. Our fiscal year 2020 results show that NCI increased
the number of competing R01s we issued within the payline by more than
100 awards, a jump of more than 15 percent from the prior year. The
funding increase also allowed us to pay other meritorious R01
applications that scored just outside the payline. Overall, our success
rate for fiscal year 2020 rose to 12.7 percent, from 11.6 percent in
the prior year.
The targeted increases that Congress has provided allows NCI to
increase paylines, achieve a corresponding increase in the overall NCI
application success rate, and issue more grant awards. This funding has
been critical to awarding new grants, while also allowing NCI to
support ongoing research and the breadth of core NCI research
investments, such as NCI's designated cancer centers, Specialized
Programs of Research Excellence (SPOREs), and large national networks
of clinical trials. All of these awards and programs will continue to
fuel broad, sustained progress that serves the needs of individuals
with cancer and those at risk of cancer, leading to a deeper
understanding of the biology of cancer and new strategies to prevent,
screen, diagnose, and treat cancer, in all its forms.
______
Questions Submitted by Senator Shelley Moore Capito
Question. The NCI is doing tremendous work in implementing the new
Childhood Cancer Data Initiative, which holds the promise of vastly
improving the treatment of childhood cancer and the quality of life for
survivors. The Childhood Cancer STAR Act calls for a major investment
in biorepository and bio-specimen collection.
Can you tell us how these two vital initiatives are working
together? NIH Response:
Answer. The National Cancer Institute (NCI) agrees that it is vital
for biospecimen collection and storage efforts supported through the
STAR Act and data generation, analysis, and sharing supported through
Childhood Cancer Data Initiative (CCDI) to continue to contribute to
and enhance each initiative's progress in a complementary manner. To
that end, NCI is utilizing STAR Act appropriations to support the
Children's Oncology Group (COG) Rare Tumor Populations Biobanking
project, which enables tumor tissue and germline (e.g., blood)
collection for specific groups of patients for which current tumor
tissue collection is lacking or inadequate, with priority for tumor
types such as sarcomas and brain and central nervous system tumors,
which often have the highest risk of treatment failure.
The COG Rare Tumor Populations Biobank was launched in fiscal year
2020 and is expanding in scope in fiscal year 2021. This initiative is
collaborating closely with CCDI, and with the use of fiscal year 2021
CCDI funds, tumor tissue will undergo clinically-relevant molecular
profiling through the CCDI Molecular Characterization Protocol. The COG
Rare Tumor Populations Biobank provides a critical foundation for these
characterization efforts within CCDI. The data generated will be
returned to treating physicians to help guide the diagnosis and
treatment of patients, and the data will be stored and made available
to the research community through CCDI data platforms. In addition to
rare cancer populations, the CCDI Molecular Characterization Protocol
will initially support characterization of tumors from children with
Central Nervous System (CNS) tumors and from children with soft tissue
sarcomas. The Protocol aims to collect, store, and make available
detailed clinical and molecular information for each child
participating in the study, including data that will help a pediatric
oncologist treat that patient and help researchers learn more about
childhood cancers.
NCI is also supporting a STAR Act biobanking project through the
COG to continue to expand the collection of specimens taken at the time
of relapse, as well as collecting diagnostic samples for children and
adolescents and young adults (AYAs) who have already submitted samples
at relapse through NCI's Pediatric Molecular Analysis for Therapy and
Choice (MATCH) Precision Medicine Trial. An important impediment to
understanding mechanisms of treatment failure for childhood solid
tumors is the limited numbers of paired specimens from both diagnosis
and relapse that are available for researchers to study. Specimens at
relapse are critical for evaluating biological changes between
diagnosis and relapse that can lead to the identification of mechanisms
of treatment failure and to the development of strategies for
circumventing these mechanisms. Through CCDI, Pediatric MATCH tumor
specimens from diagnosis and from relapse are being molecularly
characterized to identify the changes in gene mutations and gene
expression that occur between diagnosis and relapse, which could inform
better treatments.
These are specific examples of early and ongoing collaboration
between STAR Act and CCDI- supported projects, and more broadly, there
will be additional opportunities for data generated through STAR Act
specimen collection and survivorship research efforts to contribute to
the CCDI data ecosystem. For example, other STAR Act biobanking
projects have supported additional biospecimen collection within the
NCI-supported Childhood Cancer Survivor Study (CCSS), focused on
subsequent cancers and chronic health conditions. CCDI funds were used
to molecularly characterize specimens from patients who developed
second cancers to enhance understanding of the genetic factors that
lead to increased risk of second malignant tumors. Additionally, CCDI
funds have supported submission and management of CCSS data to NCI and
other NIH repositories so that they can be linked within the CCDI data
ecosystem and more easily shared with the broader research community.
As NCI's CCDI continues to link data resources across the childhood
cancer research field, we envision these linkages and the data
ecosystem they create serving as a resource for continued research, and
as a growing repository for all types of data generated through NCI and
other funded childhood and AYA cancer research. Similar to the CCSS,
individual research projects, including preclinical studies and
clinical trials, will have the opportunity to contribute data to CCDI,
linking this additional data to CCDI resources such as the Molecular
Characterization Protocol and the National Childhood Cancer Registry,
two foundational CCDI initiatives.
______
Questions Submitted by Senator Cindy Hyde-Smith
Question. I, along with many members of the committee remain
concerned with the lack of targeted therapies for rare cancer patients.
It is my understanding that rare cancers account for 380 of 400
distinct forms of cancer and almost 1/3 of all diagnoses and include
all pediatric cancers. A recent analysis showed that 80 percent of all
patients who lacked an FDA-targeted therapy were rare cancer patients.
In addition, of the 3,994 clinical trials in phases 1, 2, and 3 from
January 1, 2012 to January 1, 2017, almost 75 percent did not include a
rare cancer by name. While rare cancer affects every population,
translational research and commercial drug development has
traditionally neglected small patient populations. Each subtype of
cancer requires a targeted therapy in order to save a life or to
significantly improve lifespan.
What is NIH's plan to ensure there are adequate investments for
treatments for rare cancer patients and what can Congress and this
committee do to help?
Answer. The National Institutes of Health (NIH) remains committed
to supporting research to advance the understanding of all cancers,
including rare cancers, and to inform the development of targeted
cancer therapies for rare cancers and rare subtypes of cancers,
including pediatric cancers (all types and subtypes of pediatric
cancers are considered ``rare'' by definition).
The cancer research community--thanks to NIH-supported developments
in understanding the specific genes, proteins, and other unique
molecular characteristics driving certain cancer subtypes--continues to
recognize that cancer is made up of a collection of hundreds, if not
thousands, of subtypes defined by these characteristics. As a result of
National Cancer Institute (NCI)-supported efforts and other relevant
research, ``cancer'' is increasingly becoming a collection of rare
cancer subtypes.
This evolved understanding of cancer is reflected in NCI's current
clinical trials portfolio and investments in translational and basic
research, including several initiatives in the intramural Center for
Cancer Research (CCR).
Increasingly, clinical trials are examining targeted therapies
based on molecular subtypes. For example, NCI's National Clinical
Trials Network (NCTN) is currently supporting trials assessing
therapies to treat gliomas with certain genetic alterations \71\ and
pancreatic cancers with specific gene alterations.\72,73\ NCI also
supports trials that are dedicated to patients with rare tumors,
including the NCTN-supported Dual Anti-CTLA-4 and Anti-PD1-Blockade in
Rare Tumors (DART) Trial \74\ and the Rapid Analysis and Response
Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE
CANCER) Trial,\75\ which is supported by NCI's Experimental
Therapeutics Clinical Trials Network.
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\71\ www.clinicaltrials.gov/ct2/show/NCT00887146.
\72\ www.clinicaltrials.gov/ct2/show/NCT04858334.
\73\ www.clinicaltrials.gov/ct2/show/NCT04548752.
\74\ www.clinicaltrials.gov/ct2/show/NCT02834013.
\75\ www.clinicaltrials.gov/ct2/show/NCT04449549.
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To ensure that researchers have a strong pipeline of therapy
candidates to consider for use in clinical trials, NCI supports several
initiatives to support the preclinical stage of development of
therapeutics to treat rare cancers, including the NCI Experimental
Therapeutics (NeXT) Program and the Pediatric Preclinical Testing
Consortium (PPTC). The mission of NeXT is to advance clinical practice
and bring improved therapies to patients with cancer by supporting the
most promising new drug discovery and development projects. The PPTC
addresses key challenges associated with the development of new
therapies for children with cancer by developing reliable preclinical
testing data for pediatric drug candidates that can be used to inform
new agent prioritization decisions.
The first step in identifying new therapeutic targets, however, is
elucidating the basic biological mechanisms that give rise to cancers.
To further these research efforts, NCI supports the development of
resources for broad use across the cancer research community. These
resources include cell lines, organoid models, patient derived
xenograft (PDX) models, biospecimens, and other biological samples. NCI
makes drug information summaries available on its website, along with
extensive cancer treatment summaries. Additional resources include the
Developmental Therapeutics Program, the National Clinical Trials
Network (NCTN) Navigator, Patient-Derived Xenograft (PDX) Centers, PDX
Finder, the NCI Mouse Repository, and the Physician Data Query (PDQ)
Database.\76\
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\76\ A more extensive list is available at www.cancer.gov/research/
resources/.
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The Rare Tumor Patient Engagement Network, launched in fiscal year
2018 and part of NCI's CCR, leverages the resources of the NCI
intramural research program and the NIH Clinical Center to bring
together investigators, patients, and advocacy groups to study rare
tumors. Under the umbrella of this effort, NCI launched the My
Pediatric, Adolescent, and Adult Rare Tumor (MyPART) Network, a
collaboration of scientists, patients, family members, advocates, and
healthcare providers to find treatments for rare cancers. The MyPART
Network collects samples like blood, saliva, and archived biopsy tissue
from people with rare solid tumors as part of the Natural History Study
of Rare Solid Tumors. The purpose of the study is to engage rare tumor
patients and their families in the research process, study how rare
tumors grow, track participants' health history over a long period of
time, share data with other scientists, build new ways of testing new
treatments, and design new clinical trials for rare cancers. MyPART
scientists also hold clinics on rare tumors to facilitate
collaborations between researchers, patients, and advocacy
organizations; to date, MyPART has hosted clinics on chordomas, SDH-
deficient gastrointestinal stromal tumors, and medullary thyroid
cancer, and more clinics are in the planning stages. Additionally, the
NCI Comprehensive Oncology Network Evaluating Rare CNS Tumors (NCI-
CONNECT) program aims to advance the understanding of rare adult
central nervous system (CNS) cancers by establishing and fostering
patient-advocacy-provider partnerships and networks to improve
approaches to care and treatment; seven clinical studies and trials are
currently open through NCI-CONNECT.\77\
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\77\ www.cancer.gov/rare-brain-spine-tumor/refer-participate/
clinical-studies.
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Because of these and similar investments, the U.S. Food and Drug
Administration (FDA) has approved a number of therapies in recent years
for patients with rare cancer subtypes and related conditions. For
example, in May 2021, the FDA granted accelerated approval to sotorasib
(Lumakras) for patients with locally advanced or metastatic non-small
cell lung cancer (NSCLC) with alterations in the KRAS G12-C gene, a
mutation which is present in only 13.8 percentsa of NSCLC patients.
Similarly, the FDA approved selumetinib (Koselugo) in 2020 for the rare
tumor condition neurofibromatosis type 1, in patients over the age of
two, as the first approved treatment for this condition. In 2018, the
FDA granted accelerated approval to larotrectinib (Vitrakvi) for adult
and pediatric patients with solid tumors with a neurotrophic receptor
tyrosine kinase (NTRK) gene fusion. NTRK gene fusions are prevalent in
nearly all cases of certain rare cancer subtypes, including secretory
carcinoma of the breast or salivary gland and infantile fibrosarcoma;
they have also been observed in some patients with more common types of
cancer, such as glioma, melanoma, and carcinomas of the thyroid, lung,
and colon.\78\
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\78\ www.ncbi.nlm.nih.gov/pmc/articles/PMC6859817/.
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NIH will continue to support research efforts that reflect the
scientific understanding of the many subtypes of cancers, including
work that will enable the development of therapies for rare tumor
subtypes.
______
Questions Submitted to Dr. Gary Gibbons
Questions Submitted by Senator Roy Blunt
Question. Dr. Gibbons, we have all heard about the plight of COVID-
19 ``long-haulers'' who have symptoms after their acute COVID-19
infection has subsided. A growing number of studies suggest that many
patients experience some type of heart damage after contracting the
infection, even in those not sick enough to be hospitalized. According
to the American Heart Association, nearly one-fourth of those
hospitalized with COVID-19 have been diagnosed with cardiovascular
complications. A study in the Journal of the American Medical
Association stated that researchers found abnormalities in the hearts
of 79 percent of recovered patients and ``ongoing myocardial
inflammation'' in 60 percent.
Who is most at-risk of this type of heart damage, and is there
indication that this damage is permanent?
With heart damage appearing to be widespread, will screenings to
detect cardiovascular damage be included as routine follow-up care for
COVID-19 patients?
Do you have any sense of how long longitudinal studies should last
to follow long-haulers?
Answer. While severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) enters the body through the respiratory tract, the virus
also infects many other cell types and can damage multiple organs and
tissues, including the heart and blood vessels. In rare cases, acute
infection has been associated with cardiovascular complications
including acute myocardial injury, myocarditis (heart inflammation),
and arrhythmias (irregular heartbeat). This is not surprising given
that viruses frequently trigger inflammation, and as the body's immune
system fights off the virus, the inflammatory process can damage
healthy tissues, including the heart. Many different viruses are known
to cause myocardial injury and myocarditis.
Many patients with coronavirus disease 2019 (COVID-19) experience
damage to their blood vessels, leading to the formation of blood clots
(thrombosis) that can develop in or travel to vital organs, including
the heart. Blood clots in the coronary arteries can starve the heart of
oxygen and damage the heart muscle. NIH's ACTIV-4 Antithrombotics
adaptive master protocols have made progress in evaluating the safety
and effectiveness of various types of blood thinners (e.g., aspirin,
heparin, apixaban) for treating adults with signs of blood vessel
damage and thrombosis from COVID-19, known as COVID-19-associated
coagulopathy.\79\ Clinical trials are ongoing across three patient
populations (inpatient, outpatient, and convalescent or patients
recovering from COVID-19). These trials are providing valuable
information about how to help prevent moderately ill patients with
COVID-19 from progressing to intensive care, and could perhaps help
mitigate future cardiac complications. For example, ACTIV-4 has shown
that full-dose heparin is safe and effective at preventing blood clots
in moderately ill hospitalized patients and reduced the need for life
support.
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\79\ www.nih.gov/research-training/medical-research-initiatives/
activ/covid-19-therapeutics-prioritized-testing-clinical-trials#activ4.
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Studies have shown that patients with COVID-19 may show signs of
cardiac injury, detected by a release of the cardiac muscle protein
troponin into the bloodstream.\80\ Such injury is associated with worse
short-term outcomes and higher mortality. An analysis of more than 40
studies involving more than 8,000 COVID-19 patients found that venous
thromboembolism (VTE; blood clots originating in a vein) occurred in
approximately 21 percent of patients.\81\ Among COVID-19 patients
admitted to intensive care, the VTE rate was as high as 31 percent. A
review of myocarditis associated with acute COVID-19 estimated that the
incidence is less than five percent; although less than previously
thought, this could still mean a large number of patients with acute
myocarditis given that COVID-19 cases in the United States have
surpassed 33 million.
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\80\ www.heartrhythmjournal.com/article/S1547-5271(20)30625-1/
fulltext#tbl1.
\81\ pubmed.ncbi.nlm.nih.gov/33251499/.
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The incidence of continuing or new cardiac problems after COVID-19
or asymptomatic SARS-CoV-2 infection remains unknown. Although most
people with COVID-19 get better within weeks of illness, some people
experience post-acute sequelae, including chest pains, shortness of
breath, exhaustion, heart palpitations, and chest pain. In addition,
patients diagnosed with cardiac injury, thrombosis, or myocarditis
during acute COVID-19 could sustain damage to the heart that persists
long after the acute illness has passed. There is still much to be
learned about the long-term cardiovascular consequences of SARS-CoV-2
infection.
NIH's Researching COVID to Enhance Recovery (RECOVER) initiative
seeks to understand, and ultimately to prevent and treat, long COVID
and other post-acute sequelae of SARS-CoV-2 (PASC) across the
lifespan.\82\ At the center of the Initiative is an observational study
that will include adults and children recruited from ongoing studies of
COVID-19, long COVID clinics, and other cohorts. RECOVER is designed to
significantly expand both our knowledge about the full clinical
spectrum, long term outcomes, and underlying biology of PASC; as well
as our ability to provide safe and effective therapeutic interventions.
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\82\ recovercovid.org/.
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Current diagnostic protocols generally include physical, cognitive,
and psychological assessments. The evaluation of patients hospitalized
with COVID-19 includes elements of a cardiovascular evaluation,
including assessment of known cardiovascular disease and risk factors
for cardiovascular disease, assessment of symptoms that may be caused
by respiratory or cardiac disease, laboratory testing (including a
complete blood count and complete metabolic panel), chest radiograph,
electrocardiogram (ECG), and troponin testing (which is followed if
elevated). A more targeted cardiac evaluation may be needed depending
on the patient's symptoms. Patients who develop new onset heart
failure, for example, may need an echocardiogram (echo) to determine
the best course of action. One of the goals of the RECOVER meta-cohort
study is to develop core defining characteristics and diagnostic
criteria for long COVID and other forms of post-acute sequelae of SARS-
CoV-2 infection (PASC), including understanding the impact the virus
has on the cardiovascular system.
NIH plans to, and has support to follow the RECOVER meta-cohort for
at least 3 years. In addition to addressing the public health impact of
SARS-CoV-2 infection, RECOVER also has the potential to enhance our
understanding of other chronic syndromes theorized to have a viral
origin, at least in some individuals, such as chronic fatigue syndrome
and postural orthostatic tachycardia syndrome (POTS).
______
Questions Submitted by Senator Shelley Moore Capito
Question. Pulmonary fibrosis (PF) means scarring in the lungs. Over
time, the scar tissue can destroy the normal lung and make it hard for
oxygen to pass through the walls of the air sacs into the bloodstream.
PF is not just one disease--it is a group of more than 200 different
lung diseases that all look very much alike.
The most recent studies show that more than 200,000 Americans are
living with PF today. Approximately 50,000 new cases are diagnosed each
year and as many as 40,000 Americans die each year. With no known cure,
certain forms of PF, such as idiopathic pulmonary fibrosis, (IPF), may
take the lives of patients within three to 5 years from diagnosis.
PRECISIONS is the first-ever clinical trial to apply the principles
of precision medicine to the diagnosis and treatment of idiopathic
pulmonary fibrosis. PRECISIONS is supported by a $22 million grant from
the National Institutes of Health (NHLBI grant number HL145266) and
Three Lakes Foundation, a philanthropic organization.
PRECISIONS is designed as a double-blind, multi-center, randomized,
placebo-controlled trial investigating the safety and efficacy of NAC
in patients with IPF who have a specific genetic variant which is
present in 25 percent of IPF patients. The trial will enroll 200
patients from approximately 20 PFF Care Center Network (CCN) sites.
Initial recruitment into the study is being facilitated by looking at
phenotypic data from patients that are enrolled in the PFF Registry.
Can you provide an update on the NHLBI-funded PRECISIONS grant,
which seeks to shed more light on the role of genetics in pulmonary
fibrosis?
How has the COVID pandemic affected this study?
Answer. The National Heart, Lung, and Blood Institute (NHLBI) is
committed to supporting research on pulmonary fibrosis, which leads to
progressive scarring of the lungs that makes it increasingly more
difficult to breathe. PRECISIONS \83\ is a five-year study that aims to
enroll 200 patients with idiopathic pulmonary fibrosis (IPF) and use
genetic testing to identify those patients most likely to respond to an
experimental treatment, an antioxidant known as N-acetylcysteine or
NAC. This first-of-its-kind precision medicine trial builds on an
earlier study suggesting that a gene called TOLLIP influences how
patients respond to NAC, such that it might be helpful only for a
subgroup of patients who have a particular version of the gene. The
trial will enroll only that subgroup, in order to increase the
likelihood of detecting a benefit.
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\83\ reporter.nih.gov/project-details/9822535.
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PRECISIONS is co-funded by the Three Lakes Foundation, a non-profit
philanthropy that supports education and research efforts to improve
the time to diagnosis and accelerate new therapies for IPF. The study
also involves a partnership with the Pulmonary Fibrosis Foundation,
whose patient registry is being leveraged to perform molecular analyses
on biospecimens obtained from patients with IPF. These analyses are
intended to uncover novel genetic risk factors that will improve IPF
diagnosis, predict its clinical course, and understand its underlying
disease mechanisms--all of which could yield further insight into
potential targeted therapies.
The study was delayed in the latter half of fiscal year 2020 due to
COVID-19-related institutional research restrictions, which led to
NHLBI approval of a six-month interim no-cost extension. By December
2020, the investigators had successfully completed all pre-specified
project milestones for the first phase of their biphasic research plan,
including enrollment of the first study participant. NHLBI approved the
transition to the second phase of the project in March 2021. To date,
six study sites have been activated, the percentage of eligible
participants who meet the study's genotype inclusion criteria has been
exactly as expected, and recruitment has proceeded on target.
During COVID-19-related delays and uncertainty regarding the
feasibility of in-person lung function assessments (spirometry),
PRECISIONS initiated an ancillary study to understand the utility of
home spirometry to monitor patients with IPF. The study also intends to
add a COVID-19--specific questionnaire to baseline and follow-up visits
in the clinical trial as a means of leveraging this existing patient
cohort to capture additional data on the epidemiological and clinical
characteristics of COVID-19.
______
Questions Submitted by Senator Cindy Hyde-Smith
Question. Concerned about other countries' ability to obtain
vaccines quickly for their populations, the Administration recently
announced that it will support a waiver of the World Trade Organization
TRIPS Agreement, which would waive intellectual property protections
for COVID-19 vaccines. It is my understanding, however, that there are
no guarantees that the companies or countries who seek to use vaccine
manufacturer's intellectual property to make copies will be able to
deliver safe and effective vaccines, or that their manufacturing
processes will meet the strict regulatory standards necessary for
authorization. Furthermore, there are already reports of counterfeit
vaccines being used to exploit vulnerable populations in the U.S. and
around the world.
Are you concerned that giving away intellectual property via a
TRIPS waiver could make worse the problem of counterfeit and low-
quality vaccines in the market? What effect could this have on
endangering lives and undermining public confidence in the vaccines
that have been proven safe and effective?
Answer. The National Institutes of Health (NIH) is concerned about
counterfeit and low-quality vaccines; however, NIH does not have the
expertise or authority to investigate these matters. The degree to
which any TRIPS waiver addresses these issues of concern will not be
known unless and until the terms are agreed upon.
Question. The Administration recently endorsed the idea of waiving
intellectual property (IP) protections for COVID-19 vaccines, in the
hopes that it will speed up manufacturing of the vaccines around world.
However, it is my understanding that some vaccine developers are
already experiencing constraints in everything from raw materials to
fill-finish capacity critical to producing and administering vaccines.
Are you concerned that diverting critical supplies from
manufacturers with proven track records for delivering high-quality,
safe and effective vaccines could actually worsen the supply chain
constraints we're currently seeing, and not just for COVID vaccines,
but also non-COVID-19 medicines such as oncology and other infectious
diseases?
Answer. The National Institutes of Health (NIH) fully supports
efforts to ensure reliable supply chains for vaccines and other
medicines; however, NIH is not directly involved in these efforts.
______
Questions Submitted to Dr. Perez-Stable
Questions Submitted by Senator Roy Blunt
Question. Dr. Perez-Stable, we typically talk about getting
researchers into the NIH field and staying there as a pipeline.
However, when we look at the pipeline for minority researchers, it can
easily be called a funnel. We have a lot of work to do in increasing
the diversity of NIH researchers. And as the COVID-19 pandemic has
highlighted, NIH must also focus on health disparities research. The
problems to these two solutions may go hand-in-hand. I know that Dr.
Collins has started the UNITE program to look at racial inequities
within the NIH community and has started a Common Fund program to fund
transformative research into health disparities. While I commend these
steps, many of the fundamental issues these programs are trying to
address are reasons we started the Institute you fund--the National
Institute for Minority Health and Health Disparities.
Can you provide your perspective on how we get more minority
scientists into the NIH community?
And, specifically, what role should NIH take in making sure
minorities have the educational background necessary to go into STEM
fields--which often starts at the high school level, if not earlier?
Answer. The National Institutes of Health (NIH) is committed to
diversifying the research workforce and will continue to identify
opportunities to increase its focus on building and supporting a
diverse scientific workforce. The NIH UNITE initiative was developed to
address inequity in biomedical research and will help NIH to identify
more strategies and opportunities to strengthen its efforts to
diversify the research workforce and attract and prepare more students
from underrepresented backgrounds for STEM careers. The NIH already has
several efforts to diversify the STEM pipeline and to train students at
all levels of education as described below.
NIH supports several initiatives to attract and recruit more
minority scientists into the NIH intramural community. For example, the
NIH Equity Committee systematically tracks and evaluates diversity,
inclusion, and equity metrics in the intramural research program. In
addition, the Distinguished Scholars Program (DSP) enhances the
diversity of principal investigators in the NIH Intramural Research
Program (IRP) by supporting first year tenure-track investigators with
supplemental funds to start their research lab and engaging in
activities designed to foster a sense of belonging and to promote
research and career success. Moreover, the IRP provides a diverse
environment for NIH-wide scientific recruitments through the Stadtman
Tenure-Track Investigators, Lasker Clinical Research Scholars, and
Early Independent Scientists recruitment programs. This approach has
led to a greater proportion of women and scientists from
underrepresented backgrounds recruited to NIH. The 2019 DSP cohort was
comprised of approximately 7 percent Hispanics or Latinos, 27 percent
African Americans or Blacks, 27 percent Asians, 40 percent White, and
73 percent female. Among the fiscal year 2020 cohort, 21 percent was
African American or Black, 21 percent Hispanic or Latino, 21 percent
Asian, 36 percent White, and 50 percent female. Of the 15 Distinguished
Scholars selected in the 2019 cohort, nine were Stadtman Tenure-Track
Investigators, and two were Lasker Clinical Research Scholars. Of the
14 Distinguished Scholars selected in the 2020 cohort, 10 were Stadtman
Investigators, and three were Lasker Scholars.
Extramurally, NIH has dedicated efforts to recruit diverse
scientists from underrepresented groups to prepare successful NIH
grants. NIH provides Diversity Research Supplements to enhance the
diversity of the research workforce by recruiting and supporting
graduate students, post-doctoral fellows, and eligible investigators
from diverse backgrounds, including those from groups that have been
shown to be underrepresented in health-related research. These
supplements to existing grants provide a pathway to career success for
scientists from diverse backgrounds and remains relatively
underutilized. There are several other NIH programs that promote
diversifying the research workforce and some are highlighted below.
First, the NIH/National Institute on Minority Health and Health
Disparities Loan Repayment Program (NIMHD LRP), which aims to increase
the pool of qualified researchers who conduct health disparities
research. Over a 15-year period, recipients of an LRP award from NIMHD
are more likely to be awarded a subsequent NIH grant than their
counterparts who were not successful. The LRP Health Disparities
applications have now been extended to all NIH Institutes as of 2019.
Second, the Native American Research Centers for Health promote a cadre
of scientists and health research professionals interested in American
Indian/Alaska Native health research. Third, NIMHD established the
NIMHD Health Disparities Research Institute to support the research
career development of promising early-career minority health and health
disparities research scientists. Fourth, the NIH's Faculty
Institutional Recruitment for Sustainable Transformation (FIRST)
program, announced in 2020, will increase the participation of
researchers dedicated to inclusive excellence, including minority
researchers, in biomedical research at NIH-funded institutions. The aim
of the program is to enhance institutional inclusive excellence, with
diversity and equity at its core enabling biomedical research
institutions to hire a diverse cohort of early-stage research faculty
committed to inclusive excellence and diversity. The current pipeline
of underrepresented scientists is not empty with about 14 percent of
new U.S.-granted Science, Technology, Engineering and Math (STEM) PhDs
awarded to underrepresented groups and similarly 14 percent of current
medical students are from these groups.Lastly, the Science Education
Partnership Award (SEPA) Program funds innovative pre-kindergarten to
grade 12 science, technology, engineering, and mathematics (STEM) and
Informal Science Education (ISE) educational projects. SEPA projects
create partnerships among biomedical and clinical researchers and
teachers and schools, museums and science centers, media experts, and
other educational organizations. The NIH will continue to identify
opportunities to increase its focus on building and supporting a
diverse scientific workforce.
SUBCOMMITTEE RECESS
Senator Murray. The meeting is adjourned. Thank you.
[Whereupon, at 12:08 p.m., Wednesday, May 26, the
subcommittee was recessed, to reconvene subject to the call of
the Chair.]
DEPARTMENT OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2022
----------
WEDNESDAY, JUNE 9, 2021
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10:02 a.m., in room SD-124, Dirksen
Senate Office Building, Hon. Patty Murray (chairwoman)
presiding.
Present: Senators Murray, Reed, Shaheen, Schatz, Baldwin,
Murphy, Manchin, Blunt, Capito, Hyde-Smith, Braun, and Leahy.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
STATEMENT OF HON. XAVIER BECERRA, SECRETARY
OPENING STATEMENT OF SENATOR PATTY MURRAY
Senator Murray. Good morning. The Senate Appropriations
Subcommittee on Labor, Health and Human Services, Education,
and Related Agencies will come to order. Today, we are having a
hearing on the Biden administration's fiscal year 2022 budget
request for the Department of Health and Human Services.
Senator Blunt and I will each have an opening statement, then I
will introduce our witness, Secretary Becerra. After his
testimony, Senators will each have 5 minutes for a round of
questions, and before we begin, I do want to walk through the
COVID-19 safety protocols in place today, and I want to thank
all of our clerks and everyone who has worked really hard to
get this set up and help everyone stay safe and healthy.
As I mentioned before the break, with the change in
guidance from the Office of the Attending Physician, the
committee is now returning to requiring in-person attendance by
witnesses and members who wish to make statements or ask
questions. However, social distancing remains in effect, and
those who have not been fully vaccinated are strongly
encouraged to wear masks.
While we are unable to have the hearing fully open to the
public or media for in-person attendance, live video is
available on our committee website, and if you are in need of
accommodations, including closed captioning, you can reach out
to the committee or the Office of Congressional Accessibility
Services.
Secretary Becerra, I am pleased to say this budget
represents a world of change from the past few years on
healthcare, and a road map on progress for years to come. It
proposes increasing the Centers for Disease Control and
Prevention's budget by nearly a quarter, which, as we discussed
in our hearings with Director Walensky, will not only help see
our Nation through this pandemic, but help us rebuild our
public health system, and better prepare for the next one.
It also proposes serious investments to tackle other
ongoing public health crises. Healthcare providers across my
State have reported a sharp uptick in youth mental health
emergencies during this pandemic, and the national suicide rate
has been climbing for years. This budget builds on the
resources we've provided for mental health and substance use
services in our COVID-19 bills with an additional $9.7 billion
for the Substance Abuse and Mental Health Services
Administration, and an increase of $3.7 billion over fiscal
year 2021 levels.
Washington State also saw drug overdoses increase by 38
percent over the first half of 2020, and our Nation saw a
record-breaking number of overdose deaths last year. President
Biden is proposing an historic investment of $10.7 billion
across HHS (Department of Health and Human Services) programs
to end the opioid epidemic, and he is proposing we continue the
progress we've seen towards ending another epidemic by
investing $670 million in the HIV/AIDS elimination initiative.
And to aid the fight against cancer, Alzheimer's, long-term
COVID-19, and countless other diseases, President Biden is
calling for the largest budget increase for the National
Institutes of Health in the agency's history.
In the fight against systemic racism, he has proposed new
investments across the department to reduce health disparities,
and after years of relentless attacks on women's healthcare and
reproductive rights, President Biden is charting a clear path
in a new direction, one that puts women's health first, and
puts patients, not politicians, in charge of their own
healthcare decisions.
I am pleased to see this budget call for $340 million for
the Title X Family Planning Program, which helps so many
patients, particularly women of color, get birth control,
cancer screening, STD screenings, and other essential care.
This funding will build on the administration's recent progress
to restore the Title X Family Planning Program with a new
proposed rule.
The budget would also eliminate the Hyde Amendment, which
is a critical step towards ensuring every person is trusted to
make their own individual choices about their life and future,
based on their own values, no matter who they are, where they
live, or how much money they make. I do recognize that is an
area of strong disagreement among members of this committee,
but for too long, Hyde has made abortion accessible only to
those with means, while women of color and women who are paid
low incomes struggle to get care.
This budget also takes other important steps to prioritize
women's health. Our maternal death rate is the highest in the
developed world, and two in three of those deaths is
preventable. The death rate for rural mothers is 50 percent
higher, and black and native women are two to three times more
likely to die from a pregnancy-related cause than white women.
This budget will invest $220 million to combat our maternal
mortality crisis.
Domestic violence is another longstanding and urgent
problem, and one made more challenging by a pandemic that makes
it even harder for people to get away from their abusers. This
budget proposes doubling Federal funding for programs that
provide shelter and support for survivors of domestic violence.
We've also seen throughout this pandemic how the childcare
crisis has grown worse, and been particularly hard on women,
and hardest of all on women of color, and women who are paid
low wages. This budget acknowledges the importance of investing
in a bright future for every child in our Nation, and proposes
to increase funding for childcare and development block grants
by $1.5 billion in addition to the bold investments proposed in
the American Families Plan, and provide an increase of over $1
billion for Head Start and pre-school development grants.
It also acknowledges our moral obligation to provide relief
to some of the world's most vulnerable populations, including
making sure the children in our Nation's custody are treated
with decency, humanity, and kindness by calling for $1 billion
in funding for refugee programs, and $3.3 billion for the
unaccompanied children program, which has been stretched thin
by this pandemic. These funds will help ensure children in HHS
custody are quickly and safely placed in appropriate homes,
provide care and services for them while they are in HHS
custody, and provide social and legal services after they leave
HHS custody.
Secretary Becerra, I look forward to hearing more from you
on how the department is prioritizing the health and well-being
of these children, and how this funding will help that work.
I always say a budget is a reflection of your values, and
all-in-all, this budget paints a clear, encouraging picture of
President Biden's values on healthcare. It shows he values
public health, science, equity, women, children, families, and
critically, the health and well-being of every single American,
and that he believes healthcare must truly be a right in this
country, not a privilege. I look forward to working with him
and Secretary Becerra and my Senate colleagues to pass
investments like those outlined in this budget into law to take
bold steps to lower healthcare costs, and expand coverage, and
apply lessons learned from the COVID-19 pandemic. With that, I
will turn it over to Senator Blunt for his remarks.
STATEMENT OF SENATOR ROY BLUNT
Senator Blunt. Thank you, Senator Murray. Appreciate
Secretary Becerra being here today. We spent several years
working together in the House before I came to the Senate, and
you went home to become the Attorney General of California, and
I look forward to what we can do together over the next couple
of years.
Certainly, over the past year, we've faced a global
pandemic that nobody would have anticipated, and nobody was
trained for. You said in the House hearing in May that the
fight against COVID-19 isn't over yet, and certainly, I agree
with that. While the vaccination rates are going up, and the
cases are going down, we still have a lot to finish to win this
fight.
Many public experts have stated, and that includes those
within the administration, that we really do have to achieve a
certain vaccination level necessary to reach the kind of
immunity where the virus ceases to spread, and we would hope,
when it had no opportunity to spread, it would then cease to be
something we need to be concerned about right now.
But we also are going to be looking carefully to see if a
booster is going to be required, and, of course, if a booster
is required to maintain that level of immunity, it's going to
be a great obligation on you, and the administration, and the
Congress to see that we have a plan that makes that work.
We also really need to have a clear strategy to provide
vaccines to developing nations. We've seen in the past that
outbreaks like Ebola, the one thing we know is that the next
sick patient is only a plane ride away from here, and so, what
we can do to help there ultimately protects us, as well.
I'm particularly concerned about what we're doing and the
strategy we have for unaccompanied alien children. You and I
have talked about that even yesterday, and I look forward to
chances to talk about that more. Many people think that this
unaccompanied children issue has nothing to do with COVID, but,
of course, how you deal with individuals coming in from another
country does have something to do with COVID, and it also has
something to do with COVID when you're taking money from our
COVID-19 funds to deal with this problem that has to be dealt
with.
So far, the department's transferred $2.98 billion to the
unaccompanied children account to deal with the fallout of
border policies that just simply aren't working. This includes
funding specifically that came out of COVID-19 relief, out of
the American Rescue Plan. I want to remind the committee than
only a few short months ago, President Biden felt it was so
imperative to pass a COVID-19 supplemental bill that the
administration pushed a $1.9 trillion bill through on a totally
partisan vote, with no real input from my side of the aisle,
and then, immediately, almost immediately, transferred $850
million of that funding that was going to go for COVID-19
relief to this fund for unaccompanied children.
Just last week, the administration transferred another $846
million to the unaccompanied children program from COVID-19
funding. That money in the bill was intended to fund community
health centers, behavioral health centers, workforce training,
public health workforce, and other programs. Well, you know, $3
billion of that money won't be allowed to do that because we're
having to deal with a policy at the border that has to be dealt
with, with even the vice president, in the last week, trying to
do things to tell people to stop coming to the border. We have
to have a policy that works better there.
The supplemental passed in December that was written by
this committee included, and it was a bipartisan vote, included
critical resources for the Strategic National Stockpile. We saw
the problems during the pandemic of what happened if the
Stockpile wasn't there. The department already has taken $850
million from the Stockpile fund to, again, the unaccompanied
children program. I will remind all of us that we've all had
questions over the last year of why didn't we do a better job
having the Stockpile money being used for the Stockpile. We
don't want to see the Stockpile again become a fund that is
easily transferred.
Finally, the department transferred $426 million from
fiscal year Labor/HHS funds for programs like--children's
hospitals, graduate medical education, the Ryan White HIV/AIDS
Program, medical research, childcare. One of the problems in
this last bill that was passed--I hope we don't repeat this in
a bill that comes through our committee.--I don't believe we
will, but unlike language we had normally had, there was no
real restraint on transfers, no restriction on those transfers,
no requirement to justify to the committee the transfers, no
notification of the transfers.
Those things were in every other bill we passed last year.
They were not in the first bill that was passed this year, and
so, the department hasn't given us notice on all of those
transfers in a timely way, but the bill didn't require them to
give us notice in a timely way. The members on my side of the
aisle want to have discussions about how we deal with this
ongoing in a better way.
Without a dialogue with this committee, I would hope again
that we don't have the flexibility next year that we have
insisted on, like reporting and things, in the past. While we
may disagree, and I may disagree with the Department's
transfers, or even the way the Unaccompanied Children Program
has been managed, there are certainly significant areas where I
do agree.
I support the National Institutes of Health increases. I
think the new research institute at NIH (National Institutes of
Health), ARPA-H (Advanced Research Projects Agency for Health),
is in the right place at the right time with the right focus,
and I announced in our hearing last week, you remember, Chair,
that I intend to be supportive of that, and I believe we can
make it work in a way we wouldn't have envisioned before the
last couple of years, and the new things we did to step up to
the pandemic.
I certainly agree with the expansion of the Certified
Community Behavioral Health Clinics to help address the mental
health crisis. I agree with efforts to end the HIV pandemic and
bring additional resources to bear on the opioid epidemic. The
devil's always in the details, but I hope we can move forward
on those things and others, but the administration is obviously
requesting a huge increase in nondefense discretionary funding.
In the Department of Health and Human Services alone, a 23
percent increase, or an increase of $23 billion. That's
compared to a defense department budget that the increase of
1.6 percent doesn't even keep up with inflation.
For the last several years, our friends on the other side
of this dais have pushed for parity between defense and
nondefense when Republicans were in charge and were advocating
defense spending. I hope we can have, and I expect, frankly,
will have a similar discussion this year.
Finally, I wholeheartedly disagree with the
administration's removal of the longstanding Hyde Amendment.
One of things I've had a chance to do in both House and Senate
is count, and I don't believe we can get a bill out of this
committee without having the Hyde Amendment in that bill. It's
been in the Appropriations Bill for 40 years. Every person on
this committee who has ever voted for a final Labor/HHS bill
has voted for Hyde since it first appeared in 1976. I don't
think this year should be or, frankly, at the end of the day,
will be different, but it is clearly, as the chair's already
pointed out, going to be an issue we're going to vigorously
discuss.
This committee, Mr. Secretary and Chair, have been
successful over the past 6 years with passing the bill, because
we've really done things that, while they move things in a
great direction, in the right direction, I think, didn't do it
in a way that made drastic policy changes. I look forward to
that same kind of incremental approach, and look forward to
working with you, Mr. Secretary, as we move forward to continue
to head your critically important department in the right
direction, because it serves the American people, and in many
ways, serves people all over the world. Thank you, Chairman.
[The statement follows:]
Prepared Statement of Senator Roy Blunt
Thank you, Chair Murray. I appreciate Secretary Becerra
(pronounced: ba-serra) for being here today to discuss the
Administration's fiscal year 2022 budget request.
Over the past year, we have faced the challenges of a global
pandemic. At a hearing in the House in May, you testified that, ``The
fight against COVID-19 is not yet over.'' I agree. While vaccination
rates are going up and cases are going down, we're still not finished
with the fight. First, as many public health experts have stated, even
those within the Administration, there is a certain vaccination level
necessary to reach herd immunity and we're not there quite yet. Second,
we may or may not need COVID-19 boosters at some point in the future
and if we do, that will require further outreach and vaccination
campaigns. Finally, we need to have a clear strategy to provide
vaccines to developing nations. As we have seen with past infectious
disease outbreaks like Ebola, the next sick patient is only a plane
ride away.
That is why I have been particularly concerned with the
Administration's strategy on Unaccompanied Alien Children. Many may
think that one issue has nothing to do with the other. But when the
Administration is robbing Peter to pay Paul, they become inextricably
linked.
Mr. Secretary, over the past three months the Department has
transferred $2.98 billion to the Unaccompanied Children account to deal
with the fallout of the Administration's failed border policies. This
includes funding specifically for COVID-19 relief from the American
Rescue Plan. I want to remind the Committee that only a few short
months ago, President Biden felt it was so imperative to pass a COVID-
19 supplemental bill that the Administration pushed through a $1.9
trillion partisan bill, with no input from Republicans, and then almost
immediately transferred $850 million from funding that should have gone
to additional COVID-19 testing to fund additional unlicensed shelter
beds for Unaccompanied Alien Children. And just last week, the
Administration transferred an additional $846.5 million to the
Unaccompanied Children program from their partisan COVID-19 bill
intended to fund Community Health Centers, behavioral health workforce
training, public health workforce, among other programs.
Second, the bipartisan COVID-19 supplemental passed in December
that was written by this Committee included critical resources for the
Strategic National Stockpile--which has proven essential during this
pandemic, and for future crises. The Department took $850 million from
this vital stockpile under the guise that the Unaccompanied Children
program needed money due to COVID-19 and not failed border policies.
Finally, the Department transferred $426 million from fiscal year
2021 Labor/HHS funds, from programs like Children's Hospitals Graduate
Medical Education, Ryan White HIV/AIDS, medical research, and child
care. Prior to making these choices, none of these decisions were
discussed with this Committee. In fact, Members on my side of the aisle
have had no substantive discussions with you about the crisis at the
border, even though the Administration has transferred or reprogrammed
almost $3 billion of funding to address it.
I understand that the Department is not in charge of our
immigration laws and that the Department has to care for unaccompanied
children that cross the border, regardless of where they come from or
how they arrive. But without a dialogue with this Committee on how to
do so, I suspect you will not have the flexibility to run this program
next year as you have had this year. The Appropriations Committee
appropriates funding based on the budget request, through arduous
negotiations between the Senate and House, between Republicans and
Democrats. I do not think the Administration should simply ignore that.
While we may disagree on the Department's management of the
Unaccompanied Children program, there are significant places where we
agree. I support the increase to the National Institutes of Health and
think that the new research Institute at NIH is coming at the right
time with the right focus. I agree with expansion of Certified
Community Behavioral Health Clinics to help address the mental health
crisis, efforts to end the HIV epidemic, and bringing additional
resources to bear to end the opioid epidemic.
However, this is going to be a difficult year and the devil is
always in the details. For example, the Administration is requesting a
15.9% increase for non-defense discretionary funding, and the
Department of Health and Human Services is requesting a 23% increase or
an increase of $23 billion. That is significant, especially when
compared to the Defense Department's budget request doesn't even keep
up with inflation. Over the last several years, the other side of the
aisle has pushed for parity between defense and non-defense funding and
that is where we have ended up. I would expect a similar outcome this
year.
Finally, I wholeheartedly disagree with the Administration's
removal of the longstanding Hyde Amendment. The Hyde Amendment prevents
the Department from using federal taxpayer dollars to fund elective
abortions. Hyde has been included in every government funding bill for
more than 40 years. Every person on this Committee who has ever voted
for a final Labor/HHS bill has voted for Hyde since its first
appearance in 1976. And I do not think this year should be any
different.
Mr. Secretary, this Committee has been successful over the last six
years with passing a bill because we haven't made fundamental, drastic
policy changes. That is the position I took as Chairman and it will
continue to be my position this year. I hope the Department will set
aside its partisan policies to support programs that benefit all
Americans instead.
Thank you, again, for being here today.
Senator Murray. Thank you very much, Senator Blunt. I will
now introduce our witness today. It's Xavier Becerra, the
Secretary of the Department of Health and Human Services. Thank
you for joining us today. And at this point, I'm going to turn
the gavel over to Senator Reed. Thank you for being here. I
have to go introduce three constituents at another committee
meeting. I will return, but until that time, Senator Reed will
hold the gavel, and Secretary Becerra, you can begin your
testimony. Thank you.
SUMMARY STATEMENT OF HON. XAVIER BECERRA
Secretary Becerra. Madam Chair, thank you. Ranking member
Blunt, members of the committee, thank you again. The
Department of Health and Human Services is at the center of
many challenges facing our country today. The COVID-19 pandemic
has shed light on how inequities and inefficient Federal
funding can leave communities vulnerable to crisis. Now, more
than ever, we must ensure that the Department has the resources
to achieve its mission, and to build a strong public health
system, and a healthier America.
For HHS, the budget proposes $131 billion in discretionary
budget authority, and $1.5 trillion in mandatory funding. This
budget underscores the administration's commitment to prepare
the Nation for the next public health crisis, to expand access
to affordable healthcare, to address health disparities, to
tackle the opioid and other drug crises, and to invest in other
priority areas, like maternal health, Tribal health, and early
childhood education.
We know the fight against COVID-19 is not yet over, but
even as HHS works to beat the pandemic, we must also prepare
for the next public health challenge. To start, the budget
makes significant investments in our preparedness and response
capabilities, including by investing in the Strategic National
Stockpile, and the public health workforce. It provides a new
mandatory funding stream for the manufacture of medical
countermeasures here at home, to protect Americans from future
pandemics, and create U.S. jobs.
The budget includes the largest fiscal year investment in
the CDC (Centers for Disease Control and Prevention) in almost
two decades. The budget reflects the president's commitment to
expand access to quality, affordable healthcare for all
Americans. It builds on the groundbreaking reforms introduced
in the American Rescue Plan by permanently extending the
enhanced premium subsidies that put affordable healthcare
coverage within reach for millions more Americans.
The budget also expands access to home and community-based
services under Medicaid, critical services that allow older
Americans and our loved ones with disabilities to live
independently in their homes and communities. And the budget
calls for Congress to take additional steps this year to lower
the costs of prescription drugs, and further expand and improve
health coverage through additional benefits and public coverage
options.
Healthcare must be a right, not a privilege, and I will
work hard to ensure that families across the Nation are able to
secure the healthcare that they need. And as we work to expand
access to affordable healthcare and address the challenges of
COVID-19 and future pandemics, we need to address public health
crises that are already here. Like violence in our communities
and climate change.
The President's budget increases funding to support
domestic violence survivors. It addresses gun violence by
doubling funding for firearm violence prevention research and
allows HHS to play a major role in the administration's
government-wide effort to tackle the climate crisis, by
supporting research and programs identifying the human health
impacts of the climate change and establishing an Office of
Climate Change and Health Equity.
To ensure that HHS is equitably serving all Americans, the
budget invests in reducing maternal mortality and morbidity
that disproportionately impacts women of color. It builds on
the American Rescue Plan's State option to extend Medicaid
postpartum coverage, it funds a range of rural healthcare
programs, and expands the pipeline for rural health providers.
It includes a dramatic funding increase in advance
appropriations for the Indian Health Services, and it invests
in improving access to vital reproductive and preventative care
services through Title X.
To support families and build the best possible future for
our children, the budget makes major investments to ensure high
quality childcare is affordable for low- and middle-income
families, and to provide high-quality pre-K for all 3- and 4-
year-olds. We know our experiences as children shape the adults
we become. Support in childhood leads to success in the future.
To address COVID-19's unprecedented acceleration of
substance use and mental health disorders, the budget makes
historic investments in SAMHSA (Substance Abuse and Mental
Health Services Administration) to support research,
prevention, treatment, and recovery services. To support
innovation in research, the budget increases funding for NIH by
$9 billion, $6.5 billion of which will go to establish the
advanced research project agency for health, ARPA-H, with an
initial focus on cancer and other diseases such as diabetes and
Alzheimer's.
This major investment in Federal research and development
will leverage ambitious ideas to build transformational
innovation through health research and the application and
implementation of health breakthroughs.
Finally, to ensure our funds are used appropriately, the
budget invests in program integrity, including efforts to
combat fraud, waste and abuse in Medicare, Medicaid, and
private insurance.
Madam Chair, I'd like--and Mr. Chairman, I'd like to close
by recognizing the women and men at HHS for their outstanding
and tireless work fighting COVID-19 to protect the health of
their fellow Americans. To build back a prosperous America, we
need a healthy America. We've taken important steps over the
past few months to expand access to quality, affordable
healthcare, to lower healthcare premiums, and to protect
women's health at home and abroad. President Biden's budget
request builds on that progress. Thank you.
[The statement follows:]
Prepared Statement of Hon. Xavier Becerra
Chair Murray, Ranking Member Blunt, and Members of the Committee,
thank you for the opportunity to discuss the President's Fiscal Year
(FY) 2022 Budget for the Department of Health and Human Services (HHS).
I am pleased to appear before you, and I look forward to continuing to
work with you.
HHS is at the center of many challenges facing our country today--
the COVID-19 pandemic, safely caring for unaccompanied children at our
southern border, the overdose and the addiction epidemic gun violence,
racial inequality, and more--and we are rising to meet those
challenges. I am honored to be given the responsibility to lead HHS at
this time.
COVID-19 has shed light on how health inequities and insufficient
Federal funding can leave communities vulnerable to crises. The
President's Budget invests in America, demonstrates a conscious effort
to address racial disparities in health care, tackles the opioid and
other drug crises, and puts us on a better footing to take on the next
public health crisis.
Now more than ever, we must ensure that HHS has the resources to
achieve its mission and tackle these challenges after years of
underfunding. The President has put forward a budget that does just
that. The FY 2022 budget proposes $131.8 billion in discretionary
budget authority and $1.5 trillion in mandatory funding. The Labor-HHS
total is $119.5 billion, an increase of $23 billion. Investments in the
budget support families in areas such as behavioral health (mental
health and substance use), maternal health, emerging health threats,
science, data and research, tribal health, early child care and
learning, and child welfare.
To build back a prosperous America, we need a healthy America, and
President Biden's budget builds on that vision while investing in the
many programs housed at HHS to save lives.
preparing for and responding to public health crises
The fight against COVID-19 is not yet over. Even as HHS works to
beat this pandemic, we are also preparing for the next public health
crisis. The FY 2022 budget makes significant investments in our
preparedness and response capabilities.
The Strategic National Stockpile, within the HHS Office of the
Assistant Secretary for Preparedness and Response, has served a
critical role in the COVID-19 response, permitting rapid deployment of
personal protective equipment, ventilators, and medical supplies to
states, cities, tribes, and territories across the country. The budget
provides $905 million for the stockpile, $200 million above FY 2021, to
ensure that the stockpile is ready to respond to future pandemic events
and any other public health threats while maintaining a robust
inventory of critical medical supplies, enhancing visibility of the
domestic supply chain, and modernizing the stockpile's distribution
model. In addition, the budget provides $823 million, $227 million
above FY 2021, for the Biomedical Advanced Research and Development
Authority, which has supported the development of new vaccines,
therapeutics, and diagnostics for the COVID-19 response. Additional
resources will support improved medical countermeasure platforms that
will enable quicker, more effective detection and public health and
medical responses to health security threats. The budget also supports
a strong public health workforce, and addresses gaps in the existing
public health infrastructure, including at the state and local levels.
In addition to discretionary investments, the budget includes $30
billion over four years in mandatory funding for HHS, the Department of
Defense, and the Department of Energy to protect Americans from future
pandemics and create U.S. jobs through major new investments in medical
countermeasures manufacturing; research and development; and related
biopreparedness and biosecurity investments.
During this pandemic, we have seen the critical role of the Centers
for Disease Control and Prevention (CDC). To ensure that CDC is well
positioned to address current and emerging public health threats, the
budget restores capacity to the world's preeminent public health agency
by investing an additional $1.6 billion over the FY 2021 level for a
discretionary funding total of $8.7 billion. This is the largest budget
authority increase for CDC in almost two decades. A core function of
CDC is partnering with state, tribal, local, and territorial entities,
and this funding will enhance those partnerships. The budget will also
provide CDC with additional resources to further develop and expand
teams of highly trained and deployable public health experts to support
preparedness at the local level.
The COVID-19 pandemic has also shown the importance of producing
reliable data. Bad inputs lead to bad outputs, and without good data,
CDC cannot effectively prepare for, or respond to, public health
threats and make well-informed decisions to protect the American
people. With funding provided in the FY 2022 budget, CDC will build
upon previous investments in the data infrastructure to date and
continue efforts to modernize public health data collection and
analysis nationwide.
Public health threats know no borders, and CDC is working to
prevent, detect, and respond to epidemic threats at home and abroad.
With CDC experts embedded in countries around the world, CDC is
supporting global COVID-19 response by leveraging core public health
capacities and relationships built through decades of CDC global health
activities. As we continue to confront new and emerging COVID-19
variants, as well as a surge of cases in India, support for CDC's work
is even more important. CDC is working closely with U.S. government
agencies, ministries of health, and other partners to assist countries
in responding to COVID-19, while simultaneously developing and
implementing adaptations to interventions for malaria, HIV, and
vaccine-preventable diseases. With the President's proposed FY 2022
investments, CDC will not only address preparedness within the United
States, but will also support core public health capacity improvements
overseas and strengthen global health security by improving our ability
to deploy experts internationally and support efforts to prevent,
detect, and respond to emerging global biological threats. CDC will
invest in global health security and continue to fight health threats
worldwide while simultaneously enhancing domestic preparedness to
address threats here at home. Domestic health is increasingly impacted
by global factors and CDC's global health security efforts include
conducting research to ensure efficient disease response.
The Assistant Secretary for Preparedness and Response (ASPR) and
CDC investments complement preparedness activities across HHS including
basic and clinical research within National Institutes of Health (NIH)
and activities within the Food and Drug Administration (FDA) to advance
regulatory science and mitigate potential supply or drug shortages.
While we prepare for future pandemic threats, we are also facing a
public health crisis that is already here: violence in our communities.
The current public health emergency has shone a light on the issue of
domestic and gender-based violence. More than 1 in 4 women and more
than 1 in 10 men have experienced contact sexual violence, physical
violence, or stalking by an intimate partner and reported significant
impacts. The budget provides $489 million for the Administration for
Children and Families (ACF) to support and protect domestic violence
survivors, which is more than double the FY 2021 enacted levels. The
budget also provides $66 million for victims of human trafficking and
survivors of torture, more than 45 percent above FY 2021 enacted
levels.
We have also seen the devastating impact of gun violence in
communities across the country. Almost 40,000 people die as a result of
firearm injuries in the United States every year, while homicide is the
third leading cause of death for people ages 10-24. This is a public
health issue, and one that disproportionately impacts communities of
color. The budget addresses this crisis by doubling CDC and NIH funding
for firearm violence prevention research. The budget provides $100
million in discretionary funding to CDC to start a new Community
Violence Intervention initiative, in collaboration with the Department
of Justice, to implement evidence- based community violence
interventions at the local level. In addition to the discretionary
investment for the Community Violence Intervention initiative, the
budget includes a total of $5 billion in mandatory funding for CDC and
the Department of Justice, beginning in FY 2023 and continuing through
FY 2029.
The climate crisis has real public health impacts, and the HHS'
mission depends on healthy and sustainable environments. HHS thus has a
major role to play in the Administration's government-wide effort to
tackle this crisis. HHS' investments to combat climate change in the FY
2022 Budget will advance health equity, lay the foundations for
economic growth, and ensure that benefits from tackling the climate
crisis accrue to tribal communities, communities of color, low-income
households, and disadvantaged communities that have been marginalized
or overburdened. The budget includes a $100 million increase in NIH
funding to support research aimed at understanding the health impacts
of climate change, as well as an additional $100 million investment in
CDC's Climate and Health program to support efforts to understand and
identify potential health effects, including children's environmental
health considerations associated with climate change and implement
plans to adapt to a changing environment. The American Jobs Plan also
would invest $1.5 billion to increase the resilience of hospitals and
critical infrastructure, fund health emergency preparedness cooperative
agreements, and build resilience including in relation to the effects
of a changing climate.
caring for all americans through health and human services
Central to the HHS mission is the charge to enhance the health and
well-being of all Americans. The budget invests in areas across HHS to
ensure that we are equitably serving the American people. As Secretary,
I will ensure that this focus is fundamental to all of our work.
A critical part of this is investing in civil rights enforcement to
ensure that all people receiving services from HHS-conducted or HHS-
funded programs, no matter who they are, or where they live, can
receive health care free from discrimination.
The FY 2022 Budget makes expanding affordable health care access a
priority across Centers for Medicare & Medicaid Services programs. A
recently released report titled ``Health Coverage Under the Affordable
Care Act: Enrollment Trends and State Estimates'' shows that the
Affordable Care Act (ACA) has expanded health insurance coverage to
millions of Americans, and the budget goes even further. It builds on
the groundbreaking reforms introduced in the American Rescue Plan Act
by extending the enhanced premium subsidies that put affordable health
care coverage within reach of millions more Americans. These
improvements in the American Rescue Plan Act are lowering premiums for
more than nine million current enrollees by an average of $50 per
person per month. In addition, due to the COVID-19 pandemic, an ongoing
opportunity to apply for enrollment in Marketplace health care coverage
is available on HealthCare.gov through August 15. This extension
provides individuals and families a desperately needed opportunity to
get quality, affordable health insurance coverage. As of May 10, over 1
million additional Americans have signed up for health insurance
through the Marketplace, and an additional 2 million obtained improved
benefits through the Marketplace, benefitting from both reduced
premiums and more affordable cost sharing.
The FY 2022 Budget also expands access to critical home- and
community-based services (HCBS) under Medicaid, critical health care
services that allow older people and people with disabilities to live
independently in their homes and communities. The budget builds on the
additional Medicaid funding included in the American Rescue Plan that
not only expands access to these important services but also
strengthens state HCBS programs by allowing states to use the
additional money to, for example, provide additional benefits, like
mental health and substance use services, to beneficiaries, as well as
to raise wages and provide paid leave for home care workers.
I look forward to working with the Congress to achieve the
Administration's goal of lower costs and expanded and improved coverage
for all Americans. This includes reforms to lower the costs of
prescription drugs, such as allowing Medicare to negotiate payment for
certain high-cost drugs, and requiring manufacturers to pay rebates
when drug prices rise faster than inflation. We will also work to
improve Medicare, Medicaid, CHIP, and private insurance coverage, by
pursuing changes such as improving access to dental, hearing, and
vision coverage in Medicare, making it easier for eligible people to
get and stay covered in Medicaid, promoting Early and Periodic
Screening, Diagnostic and Treatment (EPSDT) requirements for eligible
youth, and reducing out-of-pocket costs for individuals in private
insurance coverage obtained through the Marketplace. The Administration
also supports additional public coverage options, including a public
option that would be available through the insurance marketplaces.
Health care is a right, not a privilege, and I will work to ensure that
families across the nation are able to secure this right.
The United States has the highest maternal mortality rate among
developed nations, with an unacceptably high mortality rate for Black
and American Indian/Alaska Native women. Addressing this critical
public health issue is a major priority of this Administration, as
evidenced by the American Rescue Plan's state option to extend Medicaid
postpartum coverage. Building on HHS's longstanding efforts to improve
maternal health, including the Department's recent Medicaid postpartum
waiver approvals, the budget provides more than $220 million in
discretionary funding to reduce maternal mortality and morbidity by
implementing evidence-based interventions to address critical gaps in
maternity care service delivery and improve maternal health outcomes.
This includes increased funding to CDC's Maternal Mortality Review
Committees and the Health Resources and Services Administration's
(HRSA) Rural Maternity and Obstetrics Management Strategies program.
HRSA also prioritizes maternal health through its Title V Maternal and
Child Health Block Grant and Alliance for Innovation on Maternal Health
programs. As with all our public health work, collecting good data will
be critical. In addition to these discretionary resources, the budget
includes $3 billion in mandatory funding over five years, to invest in
maternal health and reduce the maternal mortality rate and end race-
based disparities in maternal mortality.
HRSA's work is central to our focus on serving all Americans, given
their mission to improve health outcomes and address health
disparities. HRSA-funded Health Centers provide access to care for low-
income and marginalized populations, and they serve 1 in 11 people in
the nation. The President's Budget increase to workforce diversity
programs, highlights HRSA's commitment to supporting health care
providers dedicated to working in underserved areas and building toward
a workforce that reflects the communities it serves and is able to
provide culturally relevant care.
The budget provides $670 million across HHS to continue efforts to
end the HIV epidemic in the United States by working closely with
communities that have high rates of HIV transmission to implement
effective prevention, diagnosis, and treatment strategies, including
ones that address the disproportionate impact of HIV and Hepatitis C
infections in Tribal communities. HHS programs have already made major
progress in combating the HIV epidemic. HRSA ensures equitable access
to services and supports for low-income people with HIV through Health
Centers as well as the Ryan White HIV/AIDS Program. In 2019, 88.1
percent of those served under the Ryan White HIV/AIDS Program had
achieved viral suppression, a record level that exceeds the national
average of 64.7 percent. HHS will build on this work to end the
epidemic once and for all.
Also, directly connected to the HHS mission is the need to provide
access to high-quality care, no matter where you live. HHS will
continue to focus on the unique needs of rural communities. HHS
administers a range of programs that address rural health, from those
that serve large populations such as Health Centers, to those serving
targeted populations such as the Black Lung Clinics Program. The FY
2022 budget serves active, inactive, retired, and disabled coal miners
and their families through high-quality medical, outreach, educational,
and benefits counseling services. It also provides funding to increase
the number of individuals receiving training and serving in health
professions in rural communities, as research has shown that providers
are likely to remain in the communities where they train as residents.
HHS will also address the stark health disparities that persist in
Tribal communities by investing in the Indian Health Service (IHS),
which serves over 2.6 million American Indians and Alaska Natives. The
COVID-19 pandemic's devastating impact on Tribal communities has
demonstrated the real human toll of these disparities. The budget
provides a $2.2 billion, or 36 percent, increase for IHS in order to
take a historic step to address chronic underfunding, expand access to
high-quality health care, and address critical facilities and
information technology infrastructure deficiencies across Indian
Country. For the first time, the budget also proposes advance
appropriations for IHS to provide stability for the Indian Health
system and parity with how other Federal health agencies are funded. I
am committed to strengthening the Nation-to-Nation relationship between
the United States and Indian Tribes. To this end, the budget supports
self-determination through a consultative process to consider long-term
solutions, including mandatory funding, to ensure adequate and stable
funding for IHS.
The budget also provides an 18.7 percent increase to the Title X
Family Planning program to improve access to vital reproductive and
preventive care and to advance gender equity. Over the last two years,
nearly half of the programs supported by Title X lost providers as a
result of the 2019 regulation which added burdensome restrictions
inconsistent with quality care guidelines and ultimately resulted in
many highly qualified, longstanding healthcare entities to exit Title
X. The budget allows Title X to not only restore highly qualified
providers, but also to expand its essential services to meet increased
demand as a result of the global pandemic and resulting recession. In
2019, Title X-funded clinics served almost 3.1 million Americans, 66
percent of whom had incomes at or below the federal poverty level and
41 percent of whom were uninsured. This is nearly 1 million fewer
people served than in 2018.
investing in children's futures
Our experiences as children shape the adults we become, and support
in childhood can mean success in the future. As Frederick Douglass
wrote, ``It is easier to build strong children than to repair broken
men.'' High-quality early care and education lay a strong foundation so
that children can take full advantage of education and training
opportunities later in life. The American Jobs Plan and the American
Families Plan invest in school and child care infrastructure and
workforce training, and ensure that low and middle-income families pay
no more than 7 percent of their income on high-quality child care.
These investments include $200 billion over ten years for a national
partnership with states to offer free, high-quality, accessible, and
inclusive preschool to all three- and four-year-olds, benefitting five
million children. The budget also invests $250 billion over ten years
to make child care affordable.
The budget also provides $19.8 billion in discretionary funding for
the Department's early care and education programs in ACF, $2.8 billion
over FY 2021 enacted. This includes $11.9 billion for Head Start, which
helps young children enter kindergarten ready to learn. Head Start
programs deliver services through 1,600 agencies in local communities,
and they provide services to more than a million children and pregnant
women every year, in every U.S. state and territory. In addition, the
budget provides $7.4 billion for the Child Care and Development Block
Grant, $1.5 billion over FY 2021 enacted, to expand access to high-
quality child care for families in all corners of the country. Over a
million children receive child care subsidies every month funded by the
Child Care and Development Fund, and nearly half of the families
receiving child care subsidies reported income below the Federal
Poverty Level. These investments will improve outcomes for children
across the country.
The budget also invests in improvements to the child welfare
system, particularly to address its racial inequity. The budget
provides $100 million in new competitive grants for states and
localities to advance reforms that would reduce the overrepresentation
of children and families of color in the child welfare system and
address the disparate experiences and outcomes of these families. This
funding will also give more families the support they need to remain
safely together. The budget also provides $200 million for states and
community-based organizations to respond to, and prevent, child abuse,
over 30 percent above FY 2021 enacted.
combating mental health and substance use crises
HHS must address the public health crises associated with mental
health and substance use disorders. This need is especially urgent
given that both crises have accelerated during the COVID-19 pandemic.
Calls to mental health helplines have increased across the country as
Americans struggle with increased anxiety, depression, risk of suicide,
and trauma-related disorders resulting from the pandemic. Younger
adults, racial minorities, essential workers, and unpaid adult
caregivers are particularly impacted. Similarly, preliminary data from
2020 suggests that overdose deaths, which were already increasing,
accelerated at an unprecedented rate during the pandemic. Provisional
data suggest that over 90,000 drug overdose deaths occurred in the
United States in the 12 months ending in September 2020. That
represents a year-over-year increase of close to 29 percent.\1\ This
crisis is also evolving--overdose deaths involving substances other
than opioids are also increasing. HHS will ensure that our work is
responsive to the needs of communities across the country.
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\1\ Centers for Disease Control and Prevention. (2021). Vital
Statistics Rapid Release: Provisional Drug Overdose Death Counts.
Retrieved May 6, 2021 at https://www.cdc.gov/nchs/nvss/vsrr/drug-
overdose-data.htm.
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The budget addresses these crises through investments in the
Substance Abuse and Mental Health Services Administration.
In a historic investment, the budget provides $1.6 billion to the
Community Mental Health Services Block Grant to respond to the systemic
strain on our country's mental health care system--more than double the
FY 2021 level. To address the undeniable connection between the
criminal justice system and mental health, the discretionary request
will also invest in programs for people involved in the criminal
justice system. HHS will also focus on the behavioral impact of COVID-
19, including on children. When children and young people face Adverse
Childhood Experiences (ACEs) such as trauma, it can continue to affect
them across their lifespan, so it is critical we intervene now to
support their social, emotional, and mental well-being.
The budget also takes action to address addiction and the overdose
epidemic, investing $11.2 billion across HHS, $3.9 billion more than in
FY 2021, including $3.5 billion for the Substance Abuse Prevention and
Treatment Block Grant, which has historically failed to keep up with
increases in the cost of providing substance use care to America's
neediest citizens. For the first time, the budget includes a 10 percent
set aside for recovery support services, a critical step for building
and sustaining the nation's recovery support services infrastructure.
The Block Grant remains a critical source of funding for states,
tribes, and territories to provide prevention, treatment, and recovery
support services to their citizens. The impact of this epidemic is felt
in our communities, and the budget will direct funding to states and
Tribes to increase community-level response. The budget will also
increase access to medications for opioid use disorder and expand the
behavioral health provider workforce, particularly in underserved
areas. I greatly appreciate the investments the American Rescue Plan
Act provided to the Substance Abuse Prevention and Treatment Block
Grant, Mental Health Block Grant, and Certified Community Behavioral
Health Centers, and HHS will continue to build on these efforts.
promoting biomedical research
HHS' work is responsible for major scientific breakthroughs, and we
are committed to supporting innovative science and research in order to
advance the health and well-being of our nation. As the world's premier
biomedical research agency, NIH will continue to be at the forefront of
scientific advancements. The budget includes $52 billion for NIH, a $9
billion increase or 21 percent increase over FY 2021 enacted. Included
in this increase is $6.5 billion to establish the Advanced Research
Projects Agency for Health (ARPA-H). With an initial focus on cancer
and other diseases such as diabetes and Alzheimer's, this major
investment in Federal research and development will leverage ambitious
ideas to build transformational platforms, capabilities, and resources
to speed the application and implementation of health breakthroughs and
shape the future of health and medicine in the U.S.
This bold new approach will complement NIH's existing research
portfolio, which is a vital contributor to longer and healthier lives,
supports and trains world-class scientists, and drives economic growth.
Outside of ARPA-H, the remaining $2.5 billion increase will allow NIH
to continue investing in basic research and translating research into
clinical practice to address the most urgent challenges, such as HIV/
AIDS and ending the opioid crisis.
restoring america's promise to refugees
HHS plays a critical role in promoting the wellbeing of those
seeking refuge or relief in the U.S. The FY 2022 budget provides over
$4.4 billion to the Office of Refugee Resettlement (ORR)--an increase
of over $2.5 billion above FY 2021 enacted. This funding would allow
ORR to support an increase in the refugee admissions ceiling to 62,500
this fiscal year and to continue to rebuild the resettlement
infrastructure in order to resettle up to 125,000 refugees in FY 2022.
This funding increase also reflects a commitment to ensuring that
unaccompanied children are provided with care and services that align
with child welfare best practices while they are in ORR's custody, and
unified with relatives and sponsors as safely and quickly as possible.
Despite significant challenges posed by COVID-19 and policies from the
previous administration, HHS is humanely caring for unaccompanied
children while working to unite them with a vetted sponsor. Working
across government and in close partnership with the Department of
Homeland Security, we have substantially increased our ability to
quickly facilitate the transfer of children out of U.S. Customs and
Border Patrol custody and into child-appropriate settings, including
with fully vetted sponsors.
funding core program operations
It is simply not possible to meet the HHS mission and address all
these key changes without sufficient funding to cover our operational
needs. The FY 2022 budget invests to bolster operations. It strengthens
administrative and operational resources throughout the Department
needed to ensure proper stewardship of resources entrusted to HHS by
Congress.
providing oversight and program integrity
Given the magnitude of HHS's work-and the taxpayer dollars used to
fund it-it is critical that we ensure that our funds are used
appropriately. The budget invests in program integrity, including
efforts to combat fraud, waste, and abuse in Medicare, Medicaid, and
Private Insurance.
conclusion
I want to thank the Committee again for inviting me to discuss the
President's FY 2022 Budget for HHS, which offers a comprehensive fiscal
vision for the nation that reinvests in America's health, supports
future growth and prosperity, and meets U.S. commitments in a fiscally
sustainable way. I look forward to continuing to show how HHS helps
fulfill that vision.
Senator Reed [presiding]. Thank you very much, Mr.
Secretary. Chairwoman Murray has allowed me to go first, and
then I'll recognize Senator Blunt. Like Senator Blunt, one of
the privileges of my life in public service is having served
with you in the House of Representatives, and congratulations,
Mr. Secretary, on your well-deserved position.
NATIONAL SUICIDE PREVENTION LIFELINE
One of the legislative initiatives that I was involved with
was the National Suicide Prevention Lifeline. I worked together
with Senators Gardner, Baldwin, and Moran. We've changed the
ten-digit number to a three-digit number, and several States
have already adopted the number. Everyone has to adopt it by
next year, but the reality is we'll need more funding, because,
as more people use this number, we'll need more counselors and
more capacity.
We asked that SAMHSA provide a cost estimate to Congress on
Lifeline in early April. Could you give us an update on the
cost estimate, Mr. Secretary?
Secretary Becerra. Senator, thank you for the question,
because this one is important. Even though it's not one of the
bigger items, it is crucial for a lot of people. Just as 911
has become indispensable, 988, I believe, will become
indispensable for those who need some help in crisis.
And where we are right now, Senator, is we have had some
briefings with members on the Hill. We're trying to follow up
with those. We're hoping to move as quickly as possible. You
may have seen in the budget, the President has quadrupled the
amount of money that he would allocate for this particular 988
program and so, we would hope to receive funding for--about a
year's worth of funding of about $102 million over the 24 or so
million that there was before.
We're hoping to move quickly, but I think you're right. To
do this well, and to do it throughout the country, we may need
to come back to you.
Senator Reed. Well, thank you, Mr. Secretary, but I think
we all recognize there's been an incredible increase in
suicides, and particularly disturbing, among young people, also
among service members, and so, I appreciate your efforts to get
this thing done.
LOW INCOME HOME ENERGY ASSISTANCE PROGRAM
Turning to another issue, LIHEAP (Low Income Home Energy
Assistance Program). It's a critical program, long supportive
of it. The resources in the budget are impressive, and I
appreciate it, but one of the issues we have is getting the
word out, if you will. There are many individuals who could
participate, but they're not aware of the program. Can you
share the steps the agency is taking to conduct outreach and
make sure that eligible individuals get their LIHEAP?
Secretary Becerra. Senator, on top of increasing the budget
for the LIHEAP program, because, like you, I have been a
fighter for this program for quite some time, and we're also
reaching out. We're reaching out to the utility companies,
we're reaching out to local governments, we're trying to have
them help us reach out to people who qualify for these
services, and so, we don't want to just wait and believe that
people will hear that we're increasing the funding for LIHEAP.
We're going to try to work with our local partners, private
sector and public, to try to reach those families that really
need this funding to help them survive, and make sure, monthly-
wise they're covered.
Senator Reed. Well, thank you, Mr. Secretary. One of the
agencies that has been very effective are the community action
agencies. They have roots in the community, so, I'm sure
they're on your list, but I just wanted to mention that for the
record.
PERSONAL PROTECTIVE EQUIPMENT MANUFACTURERS
We all are concerned about PPE (Personal Protective
Equipment). We had a wake-up call during the pandemic, and we
are concerned about how you're stockpiling it in terms of
prioritizing U.S. manufacturers, or at least manufacturers that
are consistent allies of the United States, and not potential
competitors. But can you comment?
Secretary Becerra. Here I have to thank you all for the
work you did to help us stand up a sizeable pot of money, $10
billion, that will help us make sure that we're doing all we
can to increase domestic manufacturing of that. Not just the
PPE, but the types of material, and the types of product that
we need in the event of a future pandemic, or a future crisis.
And so, we're trying to adapt. The stockpile has to enter
the 21st century. We have to make sure that what we do have
stored actually will work once we need it, and we have to make
sure that what we are storing is what we need to be equipped
for the crises of the 21st century. But thank you for that
support.
Senator Reed. Well, thank you very much, Mr. Secretary, and
again, thank you for your service, and I'm extremely pleased
that you're the Secretary. Thank you.
Secretary Becerra. Thank you, Senator.
Senator Reed. Senator Blunt, please.
Senator Blunt. Thank you, Senator. Secretary, the Congress
has provided $178 billion over the course of the last year for
the Provider Relief Fund. There's another $8.5 billion in
addition to that for rural hospitals in the American Rescue
Plan that passed in January. I think most of that money has to
be spent by June 30.
You answered some questions on that at the Ways and Means
Hearing yesterday. You said we're trying to make sure we don't
make the mistakes of the past. What are a couple of those
mistakes, and how are you trying to move forward without
continuing what you think was a mistake?
Secretary Becerra. Senator, I think we would all agree that
we want to know where and why taxpayer dollars are going to
particular item or cause, and I think most people will tell
you--at least the comments that we're seeing are that there
wasn't enough transparency in the process. How the money was
allocated. Why was one provider provided dollars, in some
cases, quite a bit of money, and in other cases, other
providers who were also in need, didn't?
And so, what we want to do is provide that transparency. At
the same time, we understand that there were a number of
providers who were left behind because of the formula that was
used to disperse the dollars, based on Medicare claims.
And in many cases, if you happened to be a provider that
relied a lot on, say, Medicaid or other sources, or you
provided a lot of charity care, you might not have had the same
level of claims. That doesn't mean you didn't have the COVID
patients. So, we're trying to provide the transparency, make
sure we direct the money where it's needed, and with the money
that's still left, we want to make sure that you all can look
at this and say, we get it.
Senator Blunt. So, I think there's approximately $50
billion left. I also believe that money, most of it, needs to
be spent by June 30. What are you doing to get that money out,
and when you do get it out, what are you doing to make it more
likely that the hospitals will be able to spend that money
before the deadline?
Secretary Becerra. Senator, there's a tranche of money that
has not yet been allocated, and so the deadline for spending
that has not yet been determined, but there is money that did
go out that does have a deadline, and what we're trying to do
is, over the next few weeks, make sure we provide some guidance
so people understand how we can make sure that everyone
fulfills their commitments in getting these dollars.
We want to make sure we provide some flexibility. We also
want accountability. We want to make sure folks understand that
when they got these taxpayers dollars to help Americans in
need, that taxpayers expect that it went to help those families
in need. And so, what we'll try to do is--understand that we
can't change the process that began before, but what we can try
to do is make sure we get the accountability while trying to
provide some flexibility.
Senator Blunt. So, advice I gave the previous
administration on this in a letter I wrote last fall was, don't
make it needlessly difficult by continuing to change the
guidelines that you've giving hospitals on how they can spend
the money. So, I hope as you allocate this last amount of
money, or put out whatever guidance you need, that it doesn't
suddenly restrict what they were earlier told they could do,
but more importantly, it does let them know that you're going
to have guidelines out there that they can rely on if they
spend the money that way, that it meets the guidelines.
UNACCOMPANIED CHILDREN
On the unaccompanied children issue, Secretary, I think you
have an average of about 400 children coming in every day. You
can verify that, if you know, and how many children do you have
leaving the program every day?
Secretary Becerra. It's a number, Senator, as you know,
that fluctuates. A couple months ago, the average was probably
closer to 600, maybe above that. Today, you're probably right.
It hovers somewhere between 3 to 5 hundred a day, but we can't
predict it.
Senator Blunt. Well, the average is kind of what I'm
wondering about, both on children coming in and then children
leaving the program.
Secretary Becerra. Yes, again, right now, and what we do at
the department, my team, we try to use a week average. We go
week by week to see the trends, but I'd say you're probably
accurate. Somewhere between 3 to 5 hundred a day, over the last
week, two weeks coming in.
Those that we are discharging to a responsible sponsor,
after checking the background of those individuals, somewhere
between, probably between 4 to 6 hundred, probably closer to
the higher range of 600 than 400.
Senator Blunt. And who checks the background on the
individuals that these children are given responsibility for?
Secretary Becerra. We have a dedicated team of people
who've been trained to do background checks.
Senator Blunt. And they work for you? HHS team, or a----
Secretary Becerra. It's an HHS team. We pay for all the
services that are provided. In many cases, we've been
fortunate, the Department of Homeland Security has been very
generous in providing us with some of their personnel who have
been trained in doing intake work and processing. We have
others within the Federal Government who have volunteered, and
certainly we have folks from within HHS who are doing this.
We had to substantially increase the number of caseworkers
that we use so we could make sure we process in a timely
fashion those children's record to see if they could be
discharged to a responsible custodian.
Senator Blunt. Well, when 400 are coming in, or 500 or
coming in, but more importantly, when say, 500-600 are going
out, I know you don't want, and I don't want any of those
children to go to a place where they're less safe, where
they're going to be exploited or taken advantage of, and I
would hope you're doing everything you can dealing with those
big numbers to be sure that that does not happen.
Secretary Becerra. Senator, I can assure you, the reason
back in March and April we were looking at this and really
seeing it as a major challenge in CBP, that's Customs and
Border Protection, was having these large number of children in
their adult detention facilities, where they should not be, is
because we wanted to make sure before we took that child, we
could provide exactly what you just said.
The safety, the health requirements, wherever we are going
to place that child. We ran out of the licensed care facilities
that we typically would send these kids to a substantial time
ago. We've had to stand up a number of emergency shelters to be
able to properly house these children, and where possible, we
try to move them as quickly as we can to a safe home once we've
gone through the vetting process.
It is tough, it's challenging, and it's expensive, but
we're going to do it right.
Senator Blunt. Thank you, Mr. Secretary, thanks.
Senator Reed. Thank you very much, Senator Blunt. And now,
on behalf of Chairwoman Murray, let me recognize Senator
Schatz.
TELEHEALTH
Senator Schatz. Thank you Mr. Chairman, Ranking Member.
Thank you, Secretary. Last month, Mr. Secretary, you said that
telehealth can be a godsend. I agree. 55 senators on a
bipartisan basis who cosponsored my telehealth bill agree, but
we're facing a telehealth cliff, because your current authority
to expand Medicare's coverage of telehealth expires when the
public health emergency ends.
Unless Congress acts, we will go back to the Dark Ages,
with very limited access to telehealth. So, Secretary, do you
believe that Medicare beneficiaries should have access to
telehealth, no matter whether they live in rural or urban
areas?
Secretary Becerra. Absolutely. Telehealth is something that
we have to move towards. We learned lessons from COVID, and I
hope that you all are able to agree on legislation that gives
us more authority.
Senator Schatz. Do you think that it's important that
Medicare beneficiaries are able to use telehealth in their
homes?
Secretary Becerra. We want to make sure telehealth reaches
every part of the beneficiaries' surroundings. I want to be
careful here, because we want to make sure there's
accountability, and there are some proposals that would show
that accountability. But we want to make sure that, in fact, if
we're going to provide reimbursement for that service, that
those beneficiaries are receiving real service.
Senator Schatz. Are you satisfied that the current law that
we're utilizing under this public health emergency is working,
and that there's sufficient accountability?
Secretary Becerra. Thank you for asking it that way. I
think we need better authority.
Senator Schatz. Thank you. Do you believe that federally
qualified health centers and rural health clinics should be
able to provide telehealth services to their patients?
Secretary Becerra. Again, with accountability, yes.
Senator Schatz. Do I have your commitment to work with
Congress to provide the necessary data and technical assistance
that we need to enact these telehealth policies this year?
Secretary Becerra. You have me at hello on that one.
NATIVE HAWAIIAN HEALTH
Senator Schatz. All right. Great. Let me just talk to you a
little bit about issues of native Hawaiian health. The U.S.
shares a unique political relationship with the native Hawaiian
community. Different Federal agencies within HHS are
responsible for the administration of native healthcare
programs, but the same Federal trust responsibility requires
the provision of comprehensive, quality healthcare to native
Hawaiians, Alaska natives, and American Indians.
But native Hawaiians are often overlooked or left out of
HHS initiatives, and it does not always seem that HHS staff
understand the Federal trust responsibility to native
Hawaiians, and I don't think this is anybody's fault. We do
oftentimes fall under a different statutory architecture
because there's not a treaty relationship, there's a trust
relationship, and so, what I'm really asking is if you would
lay eyes on this particular relationship.
The way the statutory architecture works is sort of, in my
view, immaterial to whether or not we're going to recognize
this trust responsibility, and then in its implementation as we
do native Hawaiian health programs, and other dollars that flow
through HHS, we want to make sure that we are on equal footing
with all native people. Do I have your commitment for that?
Secretary Becerra. Absolutely.
PUBLIC HEALTH EMERGENCY FUND
Senator Schatz. Thank you very much. We have seen a--I want
to talk to you about one final thing, and this is the Public
Health Emergency Fund. We've seen a pattern where every few
years, when an infectious disease outbreak or public health
emergency occurs, we're taken by surprise, totally flat-footed.
The Federal Government cobbles together funding, and then
Congress appropriates.
But often, these are delayed, and they're delayed for
idiosyncratic reasons, whether the particular disease resonates
with the public, whether or not Congress is in session, and so,
you know, the idea here is to establish a reserve fund so that
you don't have to come back to Congress in order to respond to
a public health emergency.
Do you think it would be helpful for Federal response
agencies such as CDC, FDA (Food and Drug Administration), and
NIH to be able to respond proactively and get ahead of these
public health emergencies before they get out of control, and
then you have to come to Congress and ask for not a few
billion, but a few hundred billion?
Secretary Becerra. Senator, I think I have to hire you, but
yes, the answer is yes.
Senator Schatz. Well, I'm often told if this doesn't work
out, I'd be an okay staffer.
[Laughter.]
Senator Schatz. Thanks very much.
Secretary Becerra. Thank you.
Senator Murray [presiding]. Senator Manchin is next, I
believe. He is not down there? Okay, we'll turn to Senator
Baldwin.
SHORT TERM PLANS
Senator Baldwin. Thank you, Madam Chair. A record 31
million Americans have obtained coverage through the Affordable
Care Act, and that's in part thanks to this administration's
efforts to stand up a special enrollment period, and increase
funding for the Navigator Program, which assists people in
searching for a plan that's right for them. These are two of my
top priorities that I called for at the very beginning of the
pandemic, but obviously didn't occur until this year.
I know that these actions have made a huge difference in
people's lives. Unfortunately, under the previous
administration, there were rules changes that allowed the
proliferation of plans that I would refer to as junk insurance
plans, that don't have to provide the same protections based on
pre-existing conditions, et cetera.
Secretary Becerra, does the administration have any way of
knowing how many Americans have signed up for these junk
insurance plans?
Secretary Becerra. Senator, I don't know if we can give a
precise number, but we do know that the number of people who've
signed up for these plans has increased, and it is very
troublesome, because now we see the consequences when you think
you have insurance, and you go and use services, and lo and
behold, you're going to pay out-of-pocket a whole lot of money.
Senator Baldwin. Yes. We also know that many of these plans
engage in deceptive or misleading marketing practices kind of
aimed at confusing customers during both special enrollment
periods and open enrollment. At a time when comprehensive
coverage is more affordable than ever, and the administration
is working to get more Americans covered, why hasn't there been
any sort of action taken to combat these junk plans and their
practices?
Secretary Becerra. Probably the best answer there, Senator,
is stay tuned. We are looking to do some things. We want to
make sure whatever we do withstands any legal challenge, but we
are taking a close look at these plans that are really offering
no real benefit or service to the people who are paying money.
And so, I'd look forward to working with you on that, because
it is a development that is alarming, especially during this
time of pandemic when everyone needs to know what they actually
have access to.
MEDICAID REENTRY ACT
Senator Baldwin. Exactly. I look forward to working with
you on that. Incarcerated and newly released individuals who
have substance use disorder are at significant risk of overdose
and death, as well as recidivism. And during the pandemic,
these individuals have been at a substantially higher risk of
contracting and dying from COVID-19. I was proud to introduce a
bipartisan measure called the Medicaid Reentry Act, which would
allow States to restart Medicaid coverage for eligible
individuals 30 days prior to their release from a jail or
prison. This coverage is really vital to facilitating what we
might call a warm hand-off to addiction treatment and other
healthcare services. Mr. Secretary, can you speak to the
importance of providing comprehensive care for reentering
individuals, and will you commit to working with me to pass and
implement the Medicaid Reentry Act?
Secretary Becerra. Senator, not only do I want to be
supportive, we want to help get this through quicker than you
think, because so many people are falling through the cracks,
and we know that there is a way to help many of these folks.
We just put out, about 2 or 3 weeks ago, we announced $3
billion that we were putting out as a result of your good work
on the American Rescue Plan. $3 billion, half of which is going
to go towards substance use disorder services, and the other
half for mental health issues, and so, we want to get out there
quickly, and so, we look forward to working with you on this,
because this is a major endeavor.
We have money in the budget to help us deal with folks who
are reintegrating back into the community, and so, very much
prepared to do that work with you.
STRATEGIC NATIONAL STOCKPILE
Senator Baldwin. Yes. I believe you've been asked some
questions, significant questions, on the Strategic National
Stockpile already in this hearing. I just wanted to note that I
spent much of last year writing letters to the previous
administration to ensure that my State, the State of Wisconsin,
received the supplies that it needed from the Strategic
National Stockpile to combat COVID-19. And unfortunately, it
often took you know, public pleas from governors and Senators,
and letters from congressional delegations as a whole for
States to obtain the supplies that they needed during this
crisis in its early days.
And that's unacceptable. The President's fiscal year 2022
budget calls for an increase of $200 million for the Strategic
National Stockpile, including for modernizing the Stockpile's
distribution model, and increasing visibility of the domestic
supply chain to improve our response capabilities.
So, can you describe how HHS has worked to increase the
supplies available in the Stockpile? And why it's important for
us to prioritize this funding for distribution and oversight
improvements.
Secretary Becerra. Senator, first I want to thank you for
the good work that you've done here. This probably looks very
familiar, what you see in the budget, because it really follows
much of what you were proposing and calling for. And so, we do
want to increase the transport of supplies, the capabilities.
We want to refine and modernize our inventory. We want to be
able to track our supplies better. We want to be able to expand
domestic manufacturing. The $10 billion that was made available
for us to really focus on domestic manufacturing will be
critical.
All that's going to get underway. More will be done if we
get a budget that reflects those priorities. If we can move the
budget from $900 million to $1.1 billion, that's significant.
And if that is included, then we can really launch in ways that
really let us make sure that we tell the American people we're
stockpiling for what you need to get ready for in the future,
and not say, ``Oops, we didn't realize we'd need that,'' when
it finally hits us.
Senator Baldwin. Thank you.
Senator Murray. Thank you. Senator Shaheen.
Senator Shaheen. Thank you, Madam Chairman. Mr. Secretary,
we're delighted to have you in front of us this morning, and
congratulations on your new role. You are in a position that
touches the lives of the majority of Americans, and so, we
appreciate your good work.
EXCESS VACCINES
I wanted to first ask you about a news report I heard this
morning on the number of States that have excess vaccines,
coronavirus vaccines that are going to expire if we don't
figure out some way to use them. Estimates I've seen say that
as many as 500 million excess vaccines could be available by
fall.
I just came back from a trip to Eastern Europe, where they
are desperate for vaccines. While I was there, we were able to
announce the decision to provide vaccines to the country of
Georgia, and they were very pleased to hear that.
Are we considering doing more to make those excess vaccines
available to countries that are really in need?
Secretary Becerra. Senator, thank you for the question.
Obviously troubling if we do see vaccines expire, but we are
working with our state partners. The difficulty is we have to
make sure there's a process that's orderly, that we could
ensure the utility of the vaccine, and that people can have
confidence that it is still a viable vaccine.
And so, there are a number of things that we have to do if
we're going to move that vaccine, because you need to have that
chain of custody in place. And so, we're absolutely working
with our state partners on this.
We want to make sure our state partners understand that, as
much as they may want to just get out there and help somebody,
we have to do it the right way, because we have to have the
confidence that the vaccines still work.
Senator Shaheen. Well, I appreciate that. I agree that's
very important, but we know that China is doing this very well.
In fact, when I was at a dinner in Georgia, I sat next to a
woman who had just had her second vaccine from China. And so,
if they can do it, we ought to be able to do it, and we should
make this a priority. So, I hope you will agree to do your part
to help make that happen.
Secretary Becerra. We'll make it a priority, but we'll do
it our way, not China's way.
STATE OPIOID RESPONSE GRANTS
Senator Shaheen. That's appropriate. New Hampshire's one of
those States that's been very hard hit by the substance misuse,
and the opioid epidemic has hit us very hard. The decision by
the previous administration to provide set-aside funding to
help the hardest hit States was very helpful to us, those State
opioid response grants that came to us, and the support in so
many other ways.
We have gotten much better at saving people's lives through
Narcan and other means, but we're seeing people migrate to
other substances, methamphetamines, cocaine, heroin, and I hope
that you will commit to work with our office and some of those
other States that have been so hard hit so that even though our
overdose death rate may be flat, we don't see a dramatic drop
in funding because of that.
Secretary Becerra. Senator, as you probably saw in our
budget, we actually try to increase the amount of money there
is----
Senator Shaheen. Which I appreciate.
Secretary Becerra. Yes, the State opioid response grants
that are out there. And so, we hope to work with New Hampshire
and all the States. Quite honestly, there's not a State in the
country that isn't being impacted by opioids. Some, however,
like your State, more impacted than others.
And so, definitely looking forward to working with you.
This is one issue where I did a lot of work as State AG
(Attorney General). I would have thought by now we might have
heard, but I know there is a settlement in the making that will
help supplement what the Federal Government is doing, and I
hope together, with what the States acquire through a
settlement, and what we're able to do working with you, we can
actually tackle this in a meaningful way.
Senator Shaheen. Well, now that we are seeing COVID in our
rear-view mirror, it will really be important to get back to
some of those programs so that we can reach people, so that we
can make progress, and I appreciate the commitment that you
have.
CHILDCARE PROVIDERS
One of the other areas that has been heavily impacted
because of the coronavirus has been childcare. We've seen the
reports of what's happened to women because they can't get
childcare anymore. In meeting with childcare providers in New
Hampshire, they have had a very difficult time, and continue to
have, as people try and come back, and they try and provide
coverage for families. But one challenge has been expediting
the funds that are going out to States, and it's an issue for
us at the State level, as well, because of the challenge of
making sure people understand the guidance and are very clear.
What I heard from childcare providers is that they don't
want to spend money and then find out later that they haven't
complied with the rules and have to give it back. So, will you
work with New Hampshire and other States to make sure that that
guidance and assistance is there for our childcare providers,
who are really struggling at this time?
Secretary Becerra. Absolutely. Absolutely, and I look for
your guidance, and any member who wishes to make sure that we
are working closely with your state partners.
HEALTH INSURANCE SUBSIDIES
Senator Shaheen. Thank you. Finally, I've only got a few
seconds left, but if I could, Madam Chair, just ask a final
question about health insurance, because we have a chart here
that shows what would happen if we are able to address
deductibles in a way that does what the American Rescue Plan
did to help expand coverage. And what this shows is--I have
legislation that would tie the plans and deductibles to the
Gold plan rather than the Silver plan. And so, this shows what
happens for a family making $25,000 or less, in terms of the
impact of expanding the help so that they could get additional
assistance with their deductibles if we peg it to the Gold plan
rather than the Silver plan.
And you can see the numbers behind me for medium cost-
sharing assistance is $800. For the highest cost-sharing
assistance right now, it's $177. So, it would be really helpful
to families to be able to expand, thus, to help with those
deductible costs, and I hope we can work with you to do that.
Secretary Becerra. Senator, I'd only add--I know time has
expired--I'd only add that President Biden made a very strong
commitment here, and the fact that we are trying to extend
permanently the increase in subsidies that families get would
be tremendously important, because all those families who
you're pointing to who fall off that cliff, that fiscal cliff,
when they hit that point in their income, where they no longer
get the subsidies.
Senator Shaheen. Right.
Secretary Becerra. Wow. All of a sudden, they can't afford
the care, and President Biden wants to extend the good work
that you all did to provide additional subsidies for those
middle-class families. So, we want to work with you.
Senator Shaheen. Thank you, I appreciate it. Thank you,
Madam Chair.
Senator Murray. Thank you. Thank you. We have been honored
to be joined by the Chair of the full committee, Senator Leahy.
Thank you for being here. Turn to you.
Senator Leahy. Thank you very, very much. Thank you and
Senator Blunt for having this hearing. I appreciate having the
Secretary here. I should note for the record, the Secretary and
I have known each other for years. We've worked together at the
Smithsonian as regents, and he knows that I'm a huge fan of
his, and I look forward to working with him on this.
I was glad to see a large increase in funding to support
research and prevention treatment. Recovery support services,
as you can tell from Senator Shaheen's question and others, and
your own experience, really concerns all of us. We see the
fatalities in opioid overdoses going up. We tried a lot of
innovative, community-based approaches in my State of Vermont,
and with your own experience in the Congress, you know that
it's not unusual for local issues to come up among the members
of the Appropriations Committee.
ALTERNATIVES TO OPIOIDS FOR TREATMENT OF CHRONIC PAIN
But I think that research to addiction alternatives has
lagged at the Federal level. I think we have to have more
research on chronic pain management and treatment, other than
through the use of opioid painkillers, and I think that is
extremely important, because we're going to need to help people
with the chronic pains. Will your budget support funding for
alternatives to opioids for treatment of chronic pain?
Secretary Becerra. Mr. Chairman, first, great to see you,
and thank you for your concern and the work that you've done.
We're going to try to be as flexible as we can, because the
solutions to opioids will not come from Washington, D.C., the
support will, and we can provide some resources, so there are
any number of ways to tackle substance abuse disorders, and,
quite honestly, and one of the things I found when I was the
attorney general of California is that even the medications
differ in their utility State by State.
And so, we have to be able to provide our state partners,
local partners the flexibility. They're the ones that are going
to do the work. They're the ones who have the know-how. We want
to provide the support and be a partner.
Senator Leahy. I know that the University of Vermont, their
Center of Rural Addiction helps rural counties, and the budget
includes a request increase of $55 million for rural
communities' opioid response programs. And I hope we can use
that to train, recruit, retain addiction specialists to serve
in rural areas, because obviously, a State like mine, and
actually every State here, has rural areas, and I would hope
that you could look at what they're doing in the Center of
Rural Addiction that we have. There could be similar ones in
other States, and I just want you to think about how we can
most effectively use that funding.
Secretary Becerra. And Senator, again, having come from a
position as a leader in my State of California, I want to now,
as Secretary at the Federal level, make sure that I'm listening
as closely as I can to the local leaders. And so, what we try
to do should be to try to support the innovation, the best
practices locally.
Opioids is going to be very difficult, and even with all
the resources that we're providing, and that this future
settlement may provide with the attorneys general, it's still a
bear. And we've learned many things about how to deal with
opioids, but it's still going to be a bear, and so, whether
it's rural or inner city urban, there are people doing this on
the ground, and we should go with the most effective best
practices that are out there.
TELEHEALTH
Senator Leahy. Well, and I will make sure I get to you some
of the things that we're doing, because the rural health
programs are much needed. Telehealth is very needed, but then
you have the problem that many of us find in rural areas,
broadband connectivity and all these others, it's not the
medication, it's getting the telehealth there in the first
place. So, I hope your budget will address some of these
issues.
Secretary Becerra. Yes. And Senator, we spoke a little
earlier about telehealth, and one of the things you want to do
with telehealth as you learn from what COVID has taught us is
to make sure that we expand access to that Internet service, to
that technology. And it would be a shame, especially in rural
communities that you just mentioned, and its poor rural and
urban communities, if we expand telehealth but forget them
because they can't get it because they lack good broadband.
Senator Leahy. Thank you. Thank you, Madam Chairman.
Senator Murray. Thank you, Mr. Chairman. Senator Capito.
Senator Capito. Thank you, Chair Murray. I appreciate the
hearing, and thank you, Secretary Becerra, who we served
together, and congratulations on your new position. Before I
begin to ask questions, I just wanted to echo the theme that I
know Ranking Member Blunt had conveyed, and I share.
I am the ranking member on Homeland Security, and so I have
a particular interest in this, and I am, Mr. Secretary, I can't
decide if I'm frustrated or grateful, but you have overseen the
transfer and reprogramming of almost $3 billion within your
department from COVID-related purposes. I believe testing and
strategic reserve is where those dollars came from, to address
the migrant crisis at the border.
So, I'm frustrated you ignored the intent of the funds, but
I appreciate that your action signals to your own
administration something that we have been calling for months,
and that is that billions of unspent COVID funds can and should
be used for a more pressing need.
My question is--I'm very interested, obviously, as a
citizen and a representative from West Virginia, on the opioid
and overdose issue, but I think you've answered that, and we
certainly want to be a partner. When you mentioned that the
answers are local, can be found locally, I think our State in
many sections of our State, and Senator Manchin I think would
agree here, have come forth with some tremendous ideas to be
solutions to the problem that are community based, that are
widespread within the community, and that lift those
communities.
Unfortunately, the pandemic--there's a lot of backsliding,
as you know, so we've got to get this right back on the screen.
And we also have along with that an increase in my own home
county of HIV, which is very concerning to me, and I'm hoping
that the CDC, while they're in our State right now on this
issue, can be a bit more aggressive there.
ALZHEIMER'S DISEASE
What I wanted to ask, then, I'll move to another area of
passion for me, and that's the Alzheimer's disease. We saw most
recently that a new treatment that emerged and was approved,
tentatively, I think, is targeted for people at early stages of
Alzheimer's disease. And it is the only drug on the market that
aims to slow the brain's deterioration instead of just treating
the symptoms.
But along with this comes an effort that we've had,
bipartisan here in the Senate, which is this new--not new, but
the existing welcome to Medicare initial exam, where we are
empowering and trying to empower our medical professionals to
begin asking questions early to try to meet the challenges that
not just that particular Medicare patient could have, but also
the family. As you know, caring for the folks afflicted with
Alzheimer's is very intense, and very, very difficult for
families. And expensive.
But in those visits, we encourage screen detection,
diagnosis, and other things of related dementia. I think what
we have here is, if we have this progression of a possibility
of a drug that can help, we need to merge this with the welcome
to Medicare exam so that we are expanding the possibilities
that a welcome to Medicare exam could do, and sort of heading
off what could be the later ravages of Alzheimer's.
I don't know if you all have thought about that, in terms
of Medicare, what your perspectives might be there.
Secretary Becerra. Senator, you've hit on something that's
crucial as we continue to see innovation in new medicines, and
that is how do we incorporate them, because these are not
inexpensive medicines.
Senator Capito. Right.
Secretary Becerra. And so, to your point, the earlier we
start in the process of trying to detect conditions that a
person might present with, the sooner we'll know if we have to
provide these types of medicines. And it's going to save us a
lot of money if we get them upfront versus later stages when
it's extremely expensive to treat some of these very difficult,
devastating diseases.
So, I think you're absolutely right. It's the preventative
model. It's approaching folks early. It's trying to do the
intervention while you can, and maybe have a chance to either
slow, or maybe in some cases cure the condition. But certainly,
we should not be waiting until it's at its worst point.
Senator Capito. Right. I agree with that. This one is a
particular challenge, as you know, because it's not something
that maybe is apparent in your blood count, or you know, you
can physically see it. It's something that those of us who have
experienced, and comes on very gradually in some cases, and
before you know it, you can't ask that last question. So, I
thank you for your dedication here. I want to work with your
department to see if we can enhance that welcome to Medicare
wellness check so we can prevent on the front end. Thank you.
Secretary Becerra. Thank you.
Senator Murray. Senator Manchin.
DOMESTIC MANUFACTURING
Senator Manchin. Thank you, Madam Chairman. Secretary, the
Food and Drug Administration reports that nearly 40 percent of
finished drugs, and roughly 80 percent of active pharmaceutical
ingredients are manufactured abroad. Widespread shortages of
personal protective equipment, the PPEs as we know, and other
medical equipment at the beginning of the COVID-19 had a
disastrous impact on all of us, in hospitals and consumers
especially.
While global shortages of semiconductors in recent months
forced U.S. manufacturers to slow or halt production lines.
Just yesterday, President Biden directed Federal agencies to
institute whole of government efforts to strengthen domestic
competitiveness, and supply chain resilience, important to
supporting domestic manufacturing of generic essential
medicines.
So, how is HHS responding to this directive to strengthen
our domestic supply chain?
Secretary Becerra. Senator, we've had conversations on
this. And thank you, first, for providing us with some
resources. The American Rescue Plan does provide us several
billion dollars to try to move towards more domestic
manufacturing. We've also seen as a result of COVID and the
Strategic Stockpile how we lack the kinds of product and
medicines that we needed.
And so, what we're trying to do is, working within ASPR,
(Assistant Secretary for Preparedness and Response) the agency
within HHS that would deal with this, we're trying to move as
quickly as we can to start having a stockpile that really will
have us ready for the 21st century. We know COVID's not the
last pandemic, and so we want to be ready. This report that was
just issued yesterday that speaks to these issues on domestic
manufacturing will go a long way in directing all of us in how
we do this. But, no doubt, when it comes to anything related to
health, HHS has to be on top of it.
Senator Manchin. Has HHS done any type of an inventory,
looking at what manufacturing facilities might be able to be
restarted if or if not, or basically put into production for
the needs of our country?
Secretary Becerra. I'd say that's underway----
Senator Manchin. Okay.
Secretary Becerra [continuing]. Nowhere near completion.
Senator Manchin. If you can, whenever you can have your
people working on that, or we can work with them or something--
--
Secretary Becerra. Yes.
Senator Manchin [continuing]. Identifying those facilities.
Secretary Becerra. Absolutely.
OPIOIDS
Senator Manchin. Sir, also, we had 90,000 Americans die
from overdose last year. My State's been hit the hardest. We
have an average of about 70 to 75 thousand every year. We had a
spike because of the COVID. The problem that I have seen is
that basically they're putting more and more products on the
market. Manufacturers are producing larger and larger volumes.
It just doesn't stop, and I've never seen any of us being able
to stop that or thwart that, so, if we know that these opioids
are causing the problem, we need treatment centers, and we have
not enough.
I look at domestic shelters we have. When we identified
domestic violence as really an epidemic in our country, we put
domestic shelters in about every neighborhood. This is an
epidemic. Overdose. So, I've had a piece of legislation called
Lifeboat, and all we're doing is saying you will pay one penny
per milligram production fee if you're going to make opioids.
We never had opioids when you and I were growing up in it,
okay? So, if this is what they think that they need, and that's
their model business model, then you're going to pay for one
penny per milligram, and every penny of that goes into
treatment centers. So, every part of our Nation, any part of
our Nation will have treatment centers to help people. Is it
something you all think you could support, or have you heard
much about it, or can we set with yours?
Secretary Becerra. We look forward to working with you on
that because we agree. In fact, just two or three weeks ago--I
already mentioned this earlier--we put out grant funding of $3
billion, half of which----
Senator Manchin. You went $3.7. I applaud you all on the
three and a half billion.
Secretary Becerra. Yes. We're still----
Senator Manchin. But still yet, it kind of goes you know,
we hit these ebbs. This would be consistent. $2 billion a year.
One penny is $2 billion a year.
Secretary Becerra. Yes.
Senator Manchin. Unbelievable. It doesn't hurt anybody.
Secretary Becerra. Go to it. We'll offer you whatever
technical assistance and whatever else we can, because what
we're putting in our budget and we've already done through the
American Rescue Plan, what you all have been working on, we're
still not keeping pace with this epidemic.
340B
Senator Manchin. With the need. I agree with you. Thank
you. And then also, my final question. The 340B program is
essential for providing access to safe and affordable
medications for low-income West Virginians, and low-income all
over our country. Recently, HHS determined that six
pharmaceutical companies have violated the program by
restricting access to contract pharmacies.
The undermining of the 340B program by pharmaceutical
companies and pharmacies' benefit managers has taken its toll
on my West Virginia hospitals, community health centers, and
their contract pharmacy partners, and I'm sure in every State
every one of us have been hit with this. What are the next
steps that you will take as the head of HHS to ensure the
integrity of the 340B program?
Secretary Becerra. Well, Senator, as you just said, we just
put out, in writing, we didn't just say it verbally, we put
out, in writing, a clear message to these six manufacturers
that we believe that they're violating the law. You violate the
law, you pay the consequences, and so----
Senator Manchin. Has it been turned over to DOJ (Department
of Justice)?
Secretary Becerra. We're waiting for responses.
Senator Manchin. Okay.
Secretary Becerra. Some have responded, but we're waiting
for full responses. By the way, our budget also does increase
funding in this area. I think we provide almost a doubling, not
quite a doubling of the money that is available to make sure
that we can do the grant rule-making that we need. I hope what
you'll do is you'll give us more authority to actually give
clear guidance on what can be done and can't be done on 340B
because----
Senator Manchin. And I really think we could do that in a
bipartisan way, because I tell you, we're all being affected.
Every one of us.
Secretary Becerra. That would be helpful, because this way
the manufacturers can't sort of play this shell game with us.
Senator Manchin. Okay.
Secretary Becerra. They'd know what their responsibility
is.
Senator Manchin. Well, I look forward to working with you,
and thank you for your service, Secretary.
Secretary Becerra. Thank you.
Senator Manchin. Thank you, Madam Chairman.
Senator Murray. Thank you. Senator Hyde-Smith.
Senator Hyde-Smith. Thank you, Madam Chairman. Mr.
Secretary, I recently visited the border with several of my
colleagues a few months ago, and we just saw how many children
were down there. The issue that's going on. The possibility of
thousands of illegal immigrants crossing the Southern border
and being transported to our State and housed in facilities in
Mississippi is what the concern is.
UNACCOMPANIED CHILDREN
But I understand that your department reached out to many
States, including Mississippi, to identify potential housing
locations for these unaccompanied migrant children, and when
Mississippi declined to participate, your office sidestepped
State and local governments by asking private organizations and
nonprofits to house the immigrant children.
And I've been getting several calls on this. I mean, from a
friend who said the local caterer just had a called asking,
``can you put in a bid of feeding 200 seven days a week, three
times a day?'' Where is this coming from, Mr. Secretary? What
do you know about this? Do we need to get our local resources
ramped up for these children coming in? And I said, I know
nothing about this.
But this action, you know, just ignored the elected
officials, who said that they were not going to participate,
and they're not being notified or given up-to-date information.
We just have to rely on these calls that we get. But you know,
there's just no transparency whatsoever in the last few weeks,
other than calls from my local sheriff saying, ``I heard this
is happening,'' because of the inquiries being made in the
community.
It is of great concern to me and my constituents that HHS
would send distressed children to States without the
involvement or approval of those States and communities and
without the resources and security that we would need to care
for such a large influx of migrants.
But I firmly believe this administration's misguided
actions have created a humanitarian crisis on the Southern
border, and you know, they're looking for the States to pick up
the pieces, to make this happen if those children get
transported without our knowledge into our State.
Does your department plan to continue on this path and to
circumvent the will of the State governments? Do they plan to
continue that if we know best what the capabilities of us
serving those children are, and how do you plan to improve
communications with the States and provide up-to-date
transparent information on the UC (unaccompanied children)
program?
Secretary Becerra. Senator, thank you for the question.
Very important. And by the way, I hope in the future you feel
comfortable reaching out to me. I'd like to develop that
relationship with you so that your team and my team can work
together on some of these issues. On this particular matter, my
sense is that some of the information that you've been given is
not only incorrect, but it's disturbing.
We never make any approach into a State without talking to
the State's leadership, and local leadership. As you just
mentioned yourself that some of the State officials said that
they were approached and they rejected the opportunity to have
some of these migrant kids go into their State.
We have an obligation to provide a safe place for these
children. We typically look for licensed care facilities,
people who are licensed and trained to do this. They're
children. And so, we go wherever we can. We do reach out to the
State leadership to see if they will help us, but if the State
leadership doesn't want to help us with children who are in
distress, we still have an obligation to find a place for these
kids.
We do nothing behind anyone's back, because all these
facilities are licensed by the very State. And so, whoever is
telling you that they don't know anything about this is either
being disingenuous or they're not interested in helping us make
sure we take care of children. We don't offer them luxury, we
try to provide them with the basics. And we look for licensed
care facilities. We're not going to put them in a facility
where we don't have people who are trained to care for kids,
and we have to search far and wide throughout the United
States, because we don't just use facilities that are near the
borders where these kids cross.
And so, I would hope to be able to work with you and your
team to show you how we do this, because we're not hiding
anything. What I can guarantee you is that we're going to
provide a safe place for these kids while they're in our care.
However temporary it is, while they're in our care, we're going
to do this the right way. I suspect you have kids or grandkids.
I have children. No grandkids yet. I would expect whoever has
my child to take the best care they can with what they've got.
Senator Hyde-Smith. But you do understand the concerns of
the local medical facilities and law enforcement if we were to
overnight get 200 children in a small area.
Secretary Becerra. Certainly, if that were the case. But
that never happens, because we don't do something overnight.
You can't, not with 200 kids. There's nothing you can do with
200 kids that is just done overnight. We have to go through the
process of establishing the relationship. Remember, most of
these licensed facilities can't accommodate more than just a
handful of kids.
The emergency intake sites that we have stood up,
principally in places like Texas and in California, those are
large. But those take months. In some cases, maybe weeks, but
months to stand up. And there's no way to hide when you have a
facility that's holding maybe three or 400 kids, or more from
the sight of any official.
But the licensed care facilities are typically 10, 12, 20
kids, and the State knows about it because these folks, these
facilities have to seek a license from the State in order to
operate. These are facilities that operate for these migrant
children, unaccompanied migrant children. We don't take money
from the foster care program to do this. It is a separate
stand-alone program, because there are special circumstances.
These kids are here under temporary--not even status--they
are requesting asylum, and so we have to process them. That's
done by DOJ and DHS (Department of Homeland Security), but we
have the responsibility, HHS, to provide them with the care,
either under our custody, or if we're able to find a
responsible custodian, temporarily in that custodian's care.
And the only activity that might occur in your State is
only the result of having worked with that licensed care
facility to reach an arrangement to have some of these kids
housed temporarily there.
Senator Hyde-Smith. Well, we may be contacting you, because
it was a large number of calls. It was a couple hundred all in
one, and the locals--and, of course we called everybody we knew
in Mississippi, and no one knew anything about it. So, we may
be contacting you on that, because----
Secretary Becerra. Please do so.
Senator Hyde-Smith [continuing]. You know, we just
definitely want to be prepared and know those things.
Secretary Becerra. Please, I invite you to.
FETAL TISSUE RESEARCH
Senator Hyde-Smith. Another concern I have is funding
research that uses fetal tissue from unborn children who have
been aborted, I believe that science is best when it's ethical
and respects the dignity of life. I also believe that the
Americans who object to abortion should not have their taxpayer
dollars going toward purchasing fetal tissue from abortionists
like Planned Parenthood.
Furthermore, even the American Medical Association has
raised concerns regarding the serious ethical problems created
by the financial benefits to those involved in the sale of
fetal tissue. And I'm over my time, but I just want to make a
couple of points here. Is----
Senator Murray. If the Senator could be concise, we've got
another Senator waiting quite a bit of time, and you are way
over time.
Senator Hyde-Smith [continuing]. We are concerned about
that, and that the justification rule from 1995 is still being
used, and we know that science has changed a lot since 1995,
and so we may want to have another discussion about that. Thank
you, Madam Chairman.
Secretary Becerra. Look forward to it.
Senator Murray. Thank you. Senator Murphy.
Senator Murphy. Thank you very much, Madam Chair. Let me
just underscore the Secretary's remarks about these kids and
the facilities they're in. These are State-licensed facilities,
as the Secretary said repeatedly. These are not federally
licensed facilities. And so every State knows where these kids
are, and they all have the opportunity, if they want to, to
pull the license, modify the license, do whatever they need to
do.
But, let's be honest, these kids are not security concerns.
I mean, I understand there's a logistical effort necessary to
care for these kids, and I would hope that notwithstanding
folks' political opposition to the President, we would all
agree that if these kids are here applying for asylum, we
should you know, all be in the business of trying to you know,
make sure that they have a roof over their head. But they're
not a security concern. These are you know, 13-, 14-, 15-year-
old kids who you know, fled destitute poverty and violence to
come to a better life, and are temporarily in our care until
they get connected with a relative. So, I just don't want to
overstate the danger or the impact that these young people
have.
Let me just, Mr. Secretary, associate myself with the
remarks of Senator Baldwin on the short-term, limited duration
plans. I wasn't here for your answer, but I heard that you said
we should wait and stay put for additional announcements. I
hope that that is coming shortly. These plans you know, they're
just frauds. They're sold a bill of goods, these folks who pick
them up, and then find out that they actually have no
insurance, and I hope that we can get those out of the
marketplace as quickly as possible.
My question to you is around the proposal for additional
ACA (Affordable Care Act) premium subsidies, about $60 billion
in the President's budget over the next 4 years to continue the
increased subsidies, and I thank Senator Shaheen for her
advocacy and her leadership on this. I'm very supportive of
that proposal, but I just want to point out that that is $60
billion not necessarily going to consumers. That's $60 billion
that's going to the for-profit healthcare industry. That's $60
billion that's going to end up in the pockets of insurance
companies, and drug companies, medical device companies, for-
profit hospitals. You know, all sorts of entities that are just
making a king's ransom off of our healthcare system today.
I'm very glad that Senator Murray and Chairman Pallone have
kicked off a process by which we're going to, I gather, start
to come up with a path forward on a public option. The ability
to put a Medicare, Medicare-like plan on these exchanges that
does not have the kind of profit motive that private insurance
plans do, and, if done right, will provide some real price
pressure on the private sector.
PUBLIC OPTION
For instance, Senator Merkley and I have introduced what we
believe to be the sort of most aggressive public option, and in
it would be included bulk purchasing authority for you or for
CMS (Centers for Medicare and Medicaid Services) that would
result in a lower price for the Medicare-like plan. But it
would also create pressure that would have benefits to private
sector plans, as well.
What do you think of the process that has been announced in
the Senate and the House to begin conversations about public
option legislation? Do you see this as part of the answer on
price moving forward? Because my only worry about a strategy on
affordability that is predicated mostly on subsidy for the
exchanges is that that ends up just feeding the for-profit
health insurance and medical industry machine, which you know,
ends up doing very well for them, ends up in increased coverage
for Americans, but doesn't get at the price question.
Secretary Becerra. So, Senator, having served with you as
we were going through the process of passing the Affordable
Care Act, and having pushed for many of the things that you're
discussing, what I can tell is now, in this position, I just
want you all to get something done, because, give me some
authority to do something to lower costs, give me the ability
to try to drive down the cost of those services, and to expand
coverage.
Any number of good ideas, but I know that you all have to
go through this process and figure out how to get to the right
number to get something passed. The President has publicly
stated he is supportive of the public option, we have dollars
in this budget to try to support movement towards getting more
Americans onto coverage, and I would simply tell you, we're
ripe to get something done. The American public wants to see us
do something, and so, it's almost--yes to all of the above.
Just let's see something cross over the finish line.
Senator Murphy. I appreciate that the administration and
you have a lot on your plate right now, but at some point, some
leadership to point us and others in the right direction on
this question on how we construct a public option would
probably be helpful, but I thank the Chair for her leadership
on this. Thank you.
Senator Murray. Thank you. Senator Braun.
Senator Braun. Thank you, Madam Chair. Good to be talking
to you again----
Secretary Becerra. Thank you.
PARTIAL-BIRTH ABORTIONS
Senator Braun. February 23, in your nomination hearing, I
asked will you follow the law, and it was in reference to the
Hyde Amendment back then and some other things. Recently, you
were testifying in a House committee, and the subject of
partial-birth abortions came up, and I think there was some
confusion as to whether there was a law on the books or not,
and I assume that you of course now know there is.
I think what I'm interested in is not so much what you're
going to do to enforce existing law, what you might be
proposing or pushing when it comes to, you know, the issue of
abortion, sanctity of life. So, is there any interest in your
office pushing or trying to get legislation out there that
would overturn the ban on partial-birth abortions?
Secretary Becerra. Senator, thanks for the question, and
thanks for following up from our previous discussion on this. I
think the President has been fairly clear, and maybe if I
wasn't so clear in my previous testimony, I could try to
elaborate a bit. We're going to do what the law permits us to
do. We're going to follow the law. This is a subject that,
obviously, people differ on. These issues usually are premised
on very deeply held beliefs. But what I can tell you is that if
I'm doing my job, I'm following the law, and right now, Roe v.
Wade is the law of the land.
We're going to do everything we can to protect a woman's
reproductive rights, to have healthcare. We want everyone to
have access equitably to healthcare, and so, we're going to do
everything we can to make sure that whether you're rich, poor,
young, old, tall, short, you're going to have access to the
care you need.
HYDE AMENDMENT
Senator Braun. So, the current law incorporates the Hyde
Amendment, and in the President's budget, that is a clear
omission. So, does that mean that, and were you part of the
formulation of the budget you know, that would have that not as
part of it? And that's been around since 1977. So, when you
hear statements that would be unclear about an existing law of
partial-birth abortions, which you actually voted against that
law, the one banning it, it would give many of us pause in
terms of what might be done.
You're clear that you're going to respect the law, but I
think I'm more interested in what you might be interested in
doing to change the law. And the fact that the Hyde Amendment
is not part of the budget, is that something more ominous on
the horizon that it would be incorporated into law, at least
it's reflected in the proposed budget, and were you part of
crafting that omission?
Secretary Becerra. Remember, Senator that President Biden,
before he became president, said that he would be against
maintaining the Hyde Amendment, and so, the budget is a
reflection of what the President has said in the past. I have
thousands of votes in my 24 years in the House of
Representatives. I think my record's pretty clear where I stand
on this issue, as well.
But, as you just said, my obligation is to respect the law,
and the law is not established by the executive, it is
established by Congress. And so, we will respect and follow
whatever the law is that you all pass.
Senator Braun. Well, I'm glad to hear you're going to
respect the law. I think that would be the minimum that we'd
require out of anyone here in any capacity, and I think that
what you're saying is that you may be trying to change the law,
and President Biden has been clear, according to you, that he
does not want the Hyde Amendment to be part of what ideally
would be part of law in that area.
And then, what would worry some of us is that then the next
step might be taken to where partial-birth abortions come into
play, and I think it just good to be honest about what one's
intentions are, and we're in a climate right now when it looks
like there's a lot out there legislatively, and for any of us
that are passionate about the sanctity of life, it is
something--obviously, we would love to know clearly you know,
what the intentions of the administration would be. Your
intentions and lawmakers, as well. So, I think that we're not
going to get any further on that topic here today, but I
thought it was definitely worth mentioning.
Secretary Becerra. Senator, I look forward to working with
you. The art of compromise and the ability to come together is
what makes this democracy work, and so, we don't have to have
the exact same views to be able to get things done for the
country.
Senator Braun. Thank you.
Secretary Becerra. Thank you.
MATERNAL MORTALITY
Senator Murray. Thank you. Mr. Secretary, the U.S. is the
only industrialized nation where the maternal death rate is
rising. Each year, 700 women die due to pregnancy, childbirth,
or subsequent complications, according to the CDC, and the vast
majority of those deaths are preventable. Black, Tribal, and
women who live in rural areas are at much greater risk, so we
need to address the gaps in care for pregnant and postpartum
women and root out bias and discrimination in maternity care
settings.
So, I was really pleased to see your budget build on some
of our bipartisan investments that we've been making in recent
years to combat this crisis with $220 million across several
agencies within HHS. I want you to talk to us about how this
new funding will address the problems driving these disparities
for women of color and women who live in rural areas, and maybe
what lessons you've learned from the committee's initial
investments.
Secretary Becerra. Senator, thank you. This one is
important, not only because it's the right thing to do, but, as
you said, we as a country, as a Nation, a leading Nation are
doing something totally wrong when it comes to protecting
women, women who are going to help us move the next generation
of leaders. And so, it's time, and I'm thrilled that the
President saw the need to make a substantial investment here.
Not only is it the $3 billion to improve the maternal
health programs that we have under the American Families Plan
that he has proposed, but it's the $223 million that I hope we
get in funding, that's in this budget for a program that he
wants to start to help improve maternal health programs around
the country.
It is the challenge to States to say, under Medicaid, we
right now provide a woman 60 days of postpartum care after
she's delivered. We're saying, guess what? You join in, and
we'll give you--we'll help you pay for a full year's, 12
months' worth of care for that woman. Because it's not just the
delivery and the recuperation from the delivery, it's making
sure the woman is ready to move forward in that first year of
life of that child.
And so, this one's critical, and, as I've always mentioned,
this is something my wife, as an OBGYN has always talked so
much about. How we don't really care too much except for making
sure that we see the delivery go well. There's so much that
goes on before the delivery, and so much that has to go on
after. And to have in our own country, pockets of America where
women are still dying, or their children are dying at birth,
it's just incredible.
So, these are the investments that we need to make, and
it's unacceptable to not do otherwise.
Senator Murray. Well, thank you. I look forward to working
with you on that. Mr. Secretary, the number of migrant children
referred to HHS's care began steadily increasing last year,
including after courts enjoined the prior administration's
policy of applying Title 42 restrictions to unaccompanied
children. And at the same time, as you well know, COVID-related
limitations significantly reduced HHS's capacity in its entire
network of State licensed shelters.
UNACCOMPANIED CHILDREN EMERGENCY INTAKE SITES
And as a result of that, this administration inherited a
system already approaching a breaking point, and the use of
emergency intake sites has, thankfully, gotten a lot of our
kids out of CBP facilities, and the department has made some
progress in a very short period of time, I know, to reduce the
number of kids at these emergency sites.
But those sites do not provide the same level of care or
services that HHS's other facilities, and their extended use
really raises concerns. I wanted to ask you what is HHS doing
to phase out of these emergency sites as quickly as possible by
placing more kids into these State licensed facilities, and
with appropriate families and sponsors as soon and safely as
possible?
Secretary Becerra. Well, Senator, as you may have heard in
my discussion with Senator Hyde-Smith, we reach out to every
facility we can, in any part of the country. Because you're
right, while these emergency intake sites have done the job of
providing these kids with the care that you would expect, far
more than the Custom and Border Protection Service could, we
know that it's better to have them in a facility that is
licensed to provide that care.
There are any number of licensed facilities, but very few
of them we haven't already approached, and so, we're going
everywhere we can, and we have been able to expand the number
of licensed beds that have been available. There was a point
where we had more kids in emergency intake centers than we had
in licensed care facilities, when our census numbers were
really high. But we have now flipped that, and there are more
kids today in licensed care facilities than we have in these
emergency intake sites.
Senator Murray. Okay, and are you addressing the emergency
intake sites, and what are we doing there to improve the level
of care? Because they still do exist and will for a time.
Secretary Becerra. Substantial amount. Today, those intake
sites offer behavioral health services to kids, which we know
that is important for so many of these kids because they come--
--
Senator Murray. At all of the emergency intake sites?
Secretary Becerra. I think we have it at all of the sites
now. We do have behavioral health specialists who are there to
provide for their needs. We've always provided the medical
care. We were never sure when we first started standing up
these sites how long they would be around, and so, we made sure
we had the medical services. But getting behavioral health
specialists is obviously a little bit extra. It's a tougher
thing. But now, we do, because we've seen how we've had to open
a number of them.
We also now do discharge work. We actually do the process
of doing the intake, getting the information, doing the
background checks on potential custodians, sponsors. And that
wasn't done at the beginning either, because they were just
emergency intake sites to help us deal with the overflow.
But we've seen that so many of these kids would end up
staying in these sites for weeks, and so, we decided, no, let's
start doing the work now of finding a responsible sponsor that
can hold them, versus keeping them in one of these sites.
So, it's almost a full service--it is a full service. If
you go to Long Beach, California, not only is it a full-service
site, several hundred kids, but the community has so much
gotten involved that they ended up getting, and this was about
a month or so ago, 70,000 toys and books donated by the
community. Several hundred kids, but they got 70,000 gifts from
the community, which now is making it possible for us to send
some of these things to some of the other kids in some of these
other sites.
And so, it's a whole of agency approach, because we want to
make sure that we provide the right service. Again, I have to
acknowledge, this is expensive stuff. It is not easy. And we
are not going to let a child go to someone unless we feel
confident that they're going to be responsible caregivers. And
so, it's very difficult, but these are kids.
Senator Murray. Yes. Okay, thank you. Senator Blunt.
COVID-19 VACCINE GOALS
Senator Blunt. Thank you, Chair. Mr. Secretary, are we
going to reach the White House goal of 70 percent of all U.S.
adults with at least one shot by July 4, and for 160 million
Americans to be fully vaccinated by that date?
Secretary Becerra. I would not bet against this President,
Senator, because he's so far done a pretty good job of hitting
his marks, and I know he's determined, and we're working with
him to get to that 70 percent. But, quite honestly, it
shouldn't be just a goal of the President. It should be a goal
of every American to try to help us get to that 70 percent
threshold and beyond, because it's for the good of the people,
not just for the President.
Senator Blunt. Well, I agree with that. I guess we'll see
if there are enough donuts, and enough cans of beer, and
whatever else is being offered as the incentive to get people
to take that vaccine. It's really important to get this done,
and I hope we meet that goal. I'd be pleased if we exceeded it.
Who's taking principal responsibility for that?
Secretary Becerra. The President has thought it so
important that he established, even before he came into office,
this working group. Jeffrey Zients has been leading that group
for some time, and over the course, it's gone mostly from
trying to address to combat the pandemic and COVID-19, to now
making sure folks are getting vaccinated.
We're still doing all of the other things. But the major
focus has been now getting that vaccine out as best we can, and
I'm waiting for the invite, Senator, so that we can go to your
State and see the pockets that still have to get vaccinated,
and we'll do what we can.
Senator Blunt. Well, good. We'd be glad to have you, and
we're trying to do that. I think one of the lessons we learned
early on in this is you don't want to make it too complicated.
Hopefully, we won't face this situation again in a hurry, but
we might with the booster shots and, you know, the more people
that can, without wondering if they qualify, can line up and
get their vaccination, the better off we are, I think.
GRADUATE MEDICAL EDUCATION
I noticed in your budget submission that there is no
increase in children's hospitals graduate medical education. As
you know, that's the one part of medical education that's not
funded out of Medicare. We've made an increase every year in
the last 6 years. I hope you'll help us look at that again and
find an increase. There are accounts really close to that that
have increases. You know, if you don't have the opportunities
to go into children's hospitals and get your specialty that
way, you wind up going somewhere else, and I think we'd all
agree that we don't benefit from having a lack of people
focused on children's healthcare.
Secretary Becerra. GME (graduate medical education)
programs are critical. When I was in the House, I fought very
hard. LA obviously has a number of facilities, and at one
point, we almost lost MLK hospital in Los Angeles, which was
one of the safety net providers, and we fought really hard to
preserve the GME slots that we had for MLK, so that once it got
back into business, we'd still be able to bring in graduate
medical students, and so, I absolutely agree with you. We have
to do everything we can to try to increase the number of, and
supply of these doctors. Especially because, as you know, we
lack those physicians and in those specialties for children.
Senator Blunt. I'd like to figure out some way we could do
with children's medical education what we've done with all
other medical education for all other specialties. Maybe we can
work together and figure out if there is a way in some other
fund we could fund this like we fund everything else.
ACA/UNINSURED NUMBER
How many people--I know it was mentioned earlier that I
think 31 million people have insurance through the Affordable
Care Act. How many people do we believe don't have insurance
now?
Secretary Becerra. There are still probably tens of
millions. I don't want to give you a number off the top of my
head.
Senator Blunt. Will you get back to us with a number on
that?
Secretary Becerra. Absolutely.
Senator Blunt. I think when we started down this road a
decade ago, it was 30 million we thought didn't have insurance.
I'm afraid it's still about 30 million, but I'll let you take
that for the record.
Secretary Becerra. Will do, Senator.
Senator Blunt. Okay. Thank you, Chair.
Secretary Becerra. Thank you.
CHILDCARE
Senator Murray. Thank you. Mr. Secretary, the pandemic
really exposed what many of us have known for a very long time
that the childcare system in our country is really broken. And
childcare is just such an essential of our infrastructure. It's
really key to our economy, and during the pandemic, we saw four
times as many women leave the labor force as men, in large part
due to increased caregiving and distance learning
responsibilities. And the problem was even worse for Black and
Latina mothers.
So, I'm really glad to see your budget propose large
investments in childcare, including a $1.5 billion increase to
the Child Care and Development Block Grant. Prior to the
pandemic, CCDBG (Child Care and Development Block Grant)
programs served just one in seven eligible children, and the
need for the services is now expected to rise significantly
given the economic turmoil that's been created by this
pandemic.
So, talk to us about how this funding will improve access
to childcare.
Secretary Becerra. Madam Chair, you've said it. I mean, our
economy will not fully recover until we address the childcare
needs, especially for women, single women. And so, it is
important for us to make these kinds of investments. But it
still doesn't take us where we need to go. As you just
mentioned, just for those who were eligible, we were only
providing services to one in seven.
It's unfortunate that we look at it this way. Maybe it's
our tradition that we think that we could take care of our kids
ourselves, but today, that's not the reality. More often than
not, even if it's a two-parent household, both parents have to
work. And no one wants to see a scenario--I grew up being a
latchkey kid. No one wants to see a scenario where we damage
our future because we didn't think of investing in our kids.
The President's proposals to provide full-time pre-K for 3-
and 4-year-olds would be a tremendous help for a lot of
families. Providing the childcare tax credit that I know is
before you, a tremendous help. But investments in these block
grants that help those families is critical, especially for
middle and low-income families.
Senator Murray. Well, you know, there's a recent report
that showed nationwide the cost of childcare jumped, on
average, 47 percent during the pandemic. We now have people
trying to go back to work, and they're going, I couldn't afford
this before, now what am I going to do?
And another problem we're seeing is the wages for childcare
providers and early educators is abysmal, and yet these
operators are now trying to operate on extremely thin margins,
like everyone else. They can accept fewer kids, they have to
have all of the sanitation equipment. It is much harder to run
these businesses. So, I wanted to ask you how the budget
requests address the funding gap that now exists between what
parents can afford to pay and what high-quality childcare
providers need so they can operate?
Secretary Becerra. Madam Chair, probably the best way to
say it is this is what happens when you fail to invest for a
long time. It all starts to come at you, it hits you in your
face, and what we're finding is that the costs will continue to
increase, families will have a harder time, but quite honestly,
we should not be paying the dirt low wages that so many of
these childcare workers have been receiving. They deserve to be
paid for the work they do. They're taking care of our most
precious assets.
And so, we need to see them receive a decent wage and
salary, which will cost more in terms of the service for the
parents, but we have failed for so long to really invest in
taking care of our kids and helping our brothers and sisters in
America care for their kids that things are coming home to
roost. We have to make the investments. Fortunately, President
Biden wants to make those investments. I know that there's a
great deal of support in the House and in the Senate to do
something serious when it comes to childcare, whether it's the
tax credit or major direct investments, we need to do it,
because----
Senator Murray. Well, this is a top priority for me, and I
know it is for pretty much every working parent out there so,
we will work with you on that.
Secretary Becerra. Amen.
HEALTH DISPARITIES
Senator Murray. I wanted to ask you one last question. The
pandemic's deadly impact on communities of color really shows
that we have a long way to go to address systemic racism and
health inequities, and there's factors from housing to food
deserts to access to health services that can really have an
impact on somebody's health. So, I was really pleased to see
the budget focus on addressing those problems, including an
increase of $150 million for CDC's social determinates of
health activities. Can you talk a little bit about what those
initiatives will do to reduce health disparities?
Secretary Becerra. Madam Chair, the most important things
is that we're now recognizing--the fact that we're using the
words social determinants of health show how far we've come as
a Nation and as a policy-making body that we recognize that, in
so many ways, your health is determined by your background, too
often by your ZIP code, and we have to change those things,
because there are people in America who are left out. There are
places, the pockets in America where the services don't reach
them, whether it's rural America or whether it's inner-city
America.
And the President has made equity one of the prominent
features of his administration, and we will do the same at HHS.
Senator Murray. Well, thank you very much, and that will
end our hearing today. I do want to thank all of our fellow
committee members and Secretary Becerra for a very thoughtful
discussion today about the President's budget request and how
we can work together to really address some of these really
critical issues of lowering healthcare costs, and helping
families across the country get covered, address inequities,
respond to public health crisis, childcare. So much more that
is within your jurisdiction. So, really appreciate your
testimony today.
Secretary Becerra. Thank you.
ADDITIONAL COMMITTEE QUESTIONS
Senator Murray. For any Senators who wish to ask additional
questions, questions for the record will be due June 18 at 5
p.m. The hearing record will also remain open until then for
members who wish to submit additional material for the record.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted to Secretary Xavier Becerra
Questions Submitted by Senator Patty Murray
Question. The past year has been particularly devastating for
children and young adults' mental health. The CDC found the proportion
of emergency room mental health visits increased by a quarter from
April to October last year for children ages 5 and 11, and by nearly a
third for those between ages 12 and 17. Suicide attempts and
psychiatric help calls for children are also on the rise. Seattle
Children's Hospital in Washington is seeing 170 children with mental
health emergencies a week--compared to 50 before the pandemic. Sacred
Heart Children's Hospital in Spokane saw admissions to its adolescent
psychiatric unit and its pediatric floor for behavioral health issues
both rise by around 70 percent.
How does the budget request target mental health services
specifically to children and young adults?
How does the request address the ability for children to access
mental health services within their communities?
Answer. HHS is committed to providing mental health services that
address the needs of children and young adults. SAMHSA supports school-
based programming in part through Project AWARE (Advancing Wellness and
Resilience in Education). The purpose of this program is to build or
expand the capacity of State Educational Agencies, in partnership with
State Mental Health Agencies (SMHAs), to increase awareness, provide
training and promote connection to services for youth with behavioral
health needs. From October, 2016 to September, 2020, Project AWARE
trained over 56,000 providers and ensured that more than half a million
school-aged youth had access to and were referred to mental health
services.
School-based health centers (SBHC) are typically funded by U.S
DHHS-Health Resources and Services Administration (HRSA; https://
www.hrsa.gov/our-stories/school-health-centers/index.html) and/or by
individual State Departments of Health. SBHCs provide students with a
variety of age-appropriate health services, including, but not limited
to, primary medical care, health education, and nutrition education.
SBHCs are increasingly offering behavioral healthcare services such as
mental health and substance use screening, counseling, and case
management/referral services. SBHCs are often operated as a partnership
between the school and a community health organization, such as a
community health center (FQHC) or local health department; and for
behavioral health services, SBHCs often partner with local community
mental health centers.
SAMHSA has continued to expand the Certified Community Behavioral
Health Clinics (CCBHCs) through expansion grants, awarding 134 grants
in early 2021 through recent emergency funding, with up to 74
additional grants being awarded in summer of 2021 as part of the
regular appropriations process. 166 CCBHC grantees were awarded in
fiscal year 2020. SAMHSA is also planning a formal technical assistance
arrangement to support organizations in implementation and
sustainability. The CCBHC programs provide an array of critical,
integrated services to meet the behavioral health needs of communities.
CCBHCs provide a full continuum of timely, person and family-centered
services, including access to crisis services 24/7, and are
particularly focused on the needs of individuals with serious mental
illness (SMI), serious emotional disturbance (SED) and/or substance use
disorder (SUD). The program is designed to support individuals and
families who are uninsured or underinsured and who may otherwise lack
access to effective screening and treatment. The program encourages use
of telehealth and other modalities to increase reach of services and to
address barriers to care access.
Question. The fiscal year 2021 Labor-HHS bill included a new, 5
percent set aside in the Mental Health Block Grant for states to
develop crisis systems to improve their ability to respond to
individuals experiencing a mental health crisis. These systems are
intended to connect people with appropriate services, rather than
referring them to law enforcement or emergency rooms.
How does the request build on the crisis response set aside created
in the fiscal year 2021 bill and how does HHS plan to work with states
to ensure these systems are fully accessible with adequate coordination
between mental health and law enforcement?
Answer. The Community Mental Health Services Block Grant received
an increase of $825 million in the fiscal year 2022 President's Budget,
for a total of $1.6 billion, to expand access to behavioral healthcare.
Within the total, $75 million is directed to the crisis services set-
aside. This investment in crisis services will direct funding to states
to build much needed crisis systems that will provide high quality,
expeditious mental healthcare. This funding also will support the
partnering of behavioral health providers with law enforcement.
SAMHSA has been actively engaging with states on the use of MHBG
funds, including this crisis set-aside ($75 million in fiscal year 2022
President's Budget). This coordination has included technical
assistance on the use of funds, requests for information on specific
allocations of funding across the crisis continuum of care, and
recommended changes to the data reporting system. States are at
different stages in their implementation of core crisis services and
currently use the funds to expand existing core services or develop new
services. Funding regional or statewide crisis centers is an allowable,
but not required, use of the funds. There is significant variation in
the degree to which states are using MHBG funds to support activities
such as the Lifeline crisis call centers. The fiscal year 2022
President's Budget includes funds for SAMHSA to further expand the
capacity of the call centers to ensure they can respond to the expected
increase in call volume accompanying the transition to 988.
Beyond the current Lifeline functionality, it is critical that
individuals experiencing a behavioral health emergency have access to a
coordinated crisis system of care. Effectively responding to people in
crisis who are experiencing a behavioral health emergency has three
main components as outlined in SAMHSA's National Guidelines for
Behavioral Health Crisis Care: providing someone to talk to, providing
in-person response, and providing a place to go. Implementing 988
successfully will be a critical first step in the crisis response.
Current research suggests that many crises can be effectively addressed
through a call alone. In addition, call centers that have follow-along
capacity and/or access to local outpatient treatment resources can
provide enhanced crisis care. A robust crisis system, including 988
access through the Lifeline network, will decrease suicides, reduce
arrests and criminal justice involvement for individuals with
behavioral health needs, and will facilitate linkages to care to reduce
unnecessary emergency department boarding and hospitalization.
Implementation of the Lifeline, partnered with the development of a
coordinated and comprehensive behavioral health crisis services system
across the United States, will save lives.
The fiscal year 2022 President's Budget further supports local
communities in meeting the mental health needs of people who are
incarcerated by investing $45 million more in these programs for a
total of $51 million to support the needs of those who are involved in
the criminal and juvenile justice system(s) providing funding for
partnerships between mental health providers and law enforcement.
SAMHSA will award a new cohort of grants to community-based behavioral
health providers that focus specifically on the delivery of mental
disorder treatment while in jail and provide linkages to care post-
incarceration.
Question. The President's budget request includes a $77.6 million
increase for the National Suicide Prevention Lifeline in order to help
build the infrastructure necessary to make a smooth transition to the
new three-digit code (9-8-8) as required by the National Suicide
Hotline Designation Act.
Please describe how this funding will strengthen the existing
infrastructure of the Lifeline and better prepare local centers to
respond to the increase in calls expected once the transition to 9-8-8
occurs.
Answer. The creation of 988 is a once-in-a-lifetime opportunity to
strengthen and expand the Lifeline and transform America's behavioral
health crisis care system to one that saves lives by serving anyone, at
any time, from anywhere across the nation. Preparing the Lifeline for
full 988 operational readiness will require a bold vision for a system
that provides direct, life-saving services to all in need and links to
community-based providers uniquely positioned to deliver a full range
of crisis care services. SAMHSA sees 988 as the linchpin and catalyst
for a transformed behavioral health crisis system in much the same way
that, over time, 911 spurred the growth of emergency medical services
in the United States.
SAMHSA envisions a multi-phase approach to making 988 operational
and effective. SAMHSA is committed to using this investment to
strengthen the existing infrastructure and prepare for the launch of
988. The first phase is focused on increasing the capacity and
operational readiness for the National Suicide Prevention Lifeline to
accept 988 calls, chats, and texts by July of 2022. This includes
support to ensure a national back-up system or safety net. SAMHSA has
reviewed modeling estimates to anticipate the expected call volumes
with 988 rollout. The President's Budget includes funds to support the
resources needed for network and telephony infrastructure expansion,
training to harmonize protocols across all local centers, and staffing
to increase the capacity of the Lifeline to respond to the anticipated
increase in calls expected with the 988 transition.
An ideal crisis system would include state and regional crisis
hubs, which can be fully integrated with mobile crisis response, crisis
receiving facilities and follow up care. SAMHSA believes that the
crisis system will be critical to make 988 optimally effective in
addressing behavioral health crisis needs and reducing unnecessary
hospitalizations and law enforcement involvement.
Question. The budget request notes that this funding will be used
to increase the capacity to respond to text messages and to those who
need specialized services. Does the Department plan on leveraging
existing infrastructure rather than recreating these capabilities?
Answer. Yes, leveraging existing infrastructure will be
instrumental in the success of 988. Initially established by Congress
in 2005, the Lifeline is a national network of over 180 independently
operated crisis call centers, three Spanish language centers, and the
Veterans Crisis Line (VCL). The network is currently linked by the
toll-free telephone number, 1-800-273-TALK, which is available 24 hours
a day, 7 days a week. The Lifeline network also consists of 9 national
backup and 38 chat/text centers. The backup and chat/text core network
centers operate under contractual obligations through the Lifeline
Administrator, who oversees the current Lifeline cooperative agreement
from SAMHSA.
Until recently, funding for the National Suicide Prevention
Lifeline was only $7 million. This funding along with limited state
investments has been insufficient to pay local centers to answer
Lifeline calls. With the President's Budget request, as well current
state investments in the answering of Lifeline calls, important
progress is being made.
It is critical to invest in strengthening Lifeline network
operations. While further system transformation will require additional
capacities (e.g., substance use integration, coordination across the
crisis continuum, etc.), the immediate priority is ensuring the
Lifeline has sufficient resources to address the scope of contacts
addressed directly in the National Suicide Hotline Designation Act,
including individuals in suicidal or mental health crisis. In the near
term, efforts should be made to map available local resources so that
facilitated transfers and referrals can be made to support individuals
with additional needs.
SAMHSA recognizes the need for a multi-pronged approach to address
the needs of populations at higher risk of suicide. This includes both
leveraging existing technologies as well as piloting and developing
novel approaches to enhance access to crisis care.
Question. When does the Department intend to provide the
Subcommittee with the report on the costs associated with a transition
to 9-8-8?
Answer. SAMHSA has been working diligently on three important
reports to Congress--the 988 Appropriations Report, the Report on
Training and Access to 988 for High Risk Populations, and the Report on
988 Resources. SAMHSA worked collaboratively with the VA to develop the
Resources report to Congress. All three reports are in the final stages
and will be submitted to the respective Committees and your
Subcommittee shortly.
Question. The pandemic's impact on child-care has been especially
hard on communities of color, undermining parents' economic stability
and children's school readiness. Virtually all child-care workers are
women, disproportionately women of color and immigrant women who do not
receive adequate wages or benefits. COVID has only made these
inequities worse. Additionally, even before the pandemic, children of
color were less likely to attend a high- quality early learning program
than their white peers, and entered kindergarten 9 months behind their
white non-Hispanic peers in math and almost 7 months behind in reading,
on average. Furthermore, Center closures because of the pandemic have
threatened an already limited supply of care for infants and toddlers
and made it even harder for families of color to get quality,
affordable child-care. I am concerned these closures will deepen racial
and socioeconomic inequities in access to high-quality early learning
opportunities that promote kindergarten readiness for children.
What role is HHS playing in addressing the racial inequities in
child-care for families and providers?
Answer. The HHS Office of Child Care (OCC) is providing guidance,
technical assistance, and oversight to assist states, tribes, and
territories with administering the multiple rounds of COVID-19 child
care supplemental funding, including the $39 billion in child care
funding provided by the American Rescue Plan Act consisting of $24
billion in child care stabilization funds and $15 billion in
supplemental Child Care and Development Fund (CCDF) awards. This
funding is helping to stabilize and improve the child care sector and
improve access for all children and families, including addressing
racial and ethnic inequities.
The American Rescue Plan Act child care stabilization funds are
providing immediate financial relief to child care providers facing
increased costs and declining revenue. Our guidance on these funds
(Information Memorandum CCDF-ACF-IM-2021-02) indicates that
applications, technical assistance, and written resources should be
available in multiple languages, and that states are encouraged to work
with culturally relevant organizations to meet the ongoing needs of
providers receiving grants. We are also collecting data on the race,
ethnicity, and location of child care providers to track the equitable
distribution of resources.
The CCDF supplemental funds in the American Rescue Plan Act are an
unprecedented opportunity to expand access to high-quality child care
and move toward a more equitable child care system by assisting many
families and providers who have not previously participated in the
child care subsidy system--including families and providers from
communities of color. Our guidance (Information Memorandum CCDF-ACF-IM-
2021-03) strongly recommends that states prioritize increasing provider
payment rates and workforce compensation so that child care providers
can retain a skilled workforce and deliver higher-quality care to
children receiving subsidies. These steps will advance equity for
women, particularly women of color, lift families out of poverty, boost
the broader economy, increase women's labor force participation, and
improve outcomes for children. Our guidance also encourages states to
pursue opportunities to build the supply of child care--including the
use of grants and contracts--for historically-underserved populations.
The guidance also encourages states to use some of the funds for
outreach activities to underserved populations, including to
disseminate materials in multiple languages, and to fund partners and
organizations trusted by families and child care providers--including
culturally relevant organizations.
OCC has developed a number of technical assistance (TA) resources
to help state, territory, and tribal CCDF administrators and other
systems-level professionals assess and ensure equitable child care
service delivery to racially disadvantaged communities. These resources
encompass all child care settings, e.g., center-based care, family
child care, and family, friend, and neighbor care; as well as the range
of age groups served by CCDF. Our TA system embeds racial equity
considerations in the planning, development, and evaluation of new
resources to ensure they are inclusive of diverse perspectives and
responsive to disadvantaged community's needs.
--The National Center on Early Childhood Quality Assurance (ECQA) has
developed resources on considerations for leadership in early
childhood systems development and for child care licensing
systems, as well as other health equity resources to help
grantees develop integrated strategies to support the social
and emotional wellness of children by highlighting promising
strategies used by CCDF grantees. See for example Kickoff:
Office of Child Care Initiative to Improve the Social-Emotional
Wellness of Children and A Resource Guide for Developing
Integrated Strategies to Support the Social and Emotional
Wellness of Children.
--Our TA Center for the Preschool Development Grants, Birth to Five
(PDG B-5)--which supports early childhood systems development,
including child care--recently delivered a webinar on building
state capacity to consider equity in data collection,
specifically administrative data, to improve equitable access
and outcomes through data collection and analysis. The Center
also developed a research to practice brief that highlights
current research trends and implications for racial and ethnic
disparities related to early childhood, including policy
choices to reduce disparities and set children and families on
more favorable trajectories. TA website users have demonstrated
a strong interest in this equity content and it is among the
PDG B-5 TA Center's most popular links: https://
childcareta.acf.hhs.gov/improving-equity-services.
--In recognition of the disproportionate impact of the COVID-19
pandemic on indigenous communities, OCC has made a focused
effort over the last year to identify ways to support Tribal
CCDF programs' response and recovery. Understanding that
cultural connection is a strength and resiliency factor in
tribal children and families, the National Center on Tribal
Early Childhood Development (NCTECD) has developed a number of
resources to support grantees with culturally relevant quality
improvement activities, including resources focused on CCDF
quality requirements; ideas and innovations for quality
improvement activities that meet community needs; support with
planning, including prioritization and budgeting; and
developing clear and strong policies and procedures. See
https://childcareta.acf.hhs.gov/quality-improvement- resource-
page.
In addition, our TA providers regularly refer states and other TA
recipients to resources published by national organizations (such as
the Annie Casey Foundation and Child Trends) that center racial equity
in the development and implementation of child care policies and
practices. These resources are used in the provision of intensive/
individualized, targeted/group, and universal TA strategies depending
on grantee need and readiness.
Looking ahead, the Biden-Harris Administration's Build Back Better
vision for early childhood would add substantial ongoing investments to
early learning services and infrastructure and continue the momentum
created by the American Rescue Plan Act--to benefit all children,
families and providers--including in communities of color. The
President's fiscal year 2022 Budget includes $250 billion over 10 years
to make child care affordable and to modernize and expand child care
facilities. High-quality early care and education opportunities lay a
strong foundation so that children can take full advantage of education
and training opportunities later in life. The President's Build Back
Better invests in child care infrastructure and workforce training and
ensures that low and middle-income families pay no more than 7 percent
of their income on high-quality child care. The Build Back Better also
proposes $200 billion for a national partnership with states to offer
free, high-quality, accessible, and inclusive prekindergarten to all
three- and four-year-olds. The proposed universal prekindergarten
program is designed to give states incentives to build out their
existing pre-k programs to reach more 3- and 4 -year-olds and to
increase program quality by building on what has already been
established in states. The Budget also proposes increased funding
levels for existing early care and education programs, including nearly
$11 billion for CCDF and a total of $11.9 billion for Head Start.
Question. Title X is the only Federal program dedicated to
providing family planning services for people who are paid low incomes.
It disproportionately serves communities of color, where the pandemic
has hit the hardest and exposed sharp disparities in access to care.
Sadly, this critical program has been chronically underfunded for too
long. The President's Budget proposes to increase the program by $54
million, its first increase in nearly a decade. Yet, research shows
Title X would need hundreds of millions more annually to provide family
planning services to all women without insurance and who are paid low
incomes in the United States.
Please explain how HHS plans to use this increase to help increase
access for women of color and women who are paid low incomes?
Answer. HHS agrees the nation must take swift action to prevent and
remedy stark racial and ethnic disparities in health and healthcare
delivery in America, including advancing equity and reducing health
disparities in all healthcare programs. As you noted, the budget
provides a 19 percent increase to the Title X Family Planning program
for a total of $340 million to support family planning services for
approximately 3.5 million persons, with approximately 90 percent having
family incomes at or below 200 percent of the Federal poverty level and
a disproportionate number of clients served identify as a person of
color. The Office of Population Affairs (OPA), part of the Office of
the Assistant Secretary for Health (OASH), advises the HHS Secretary on
a range of public health priorities including quality family planning
and adolescent health and serves as a key stakeholder on HHS' effort to
advance health equity.
OPA administers the Title X family planning program, the only
Federal program devoted solely to the provision of family planning and
related preventive healthcare. By law, under the Title X program,
priority is given to individuals from low-income families, which
include many communities of color. On January 28, 2021, President Biden
issued a ``Memorandum on Protecting Women's Health at Home and Abroad''
directing the Department to review the 2019 Title X Final Rule and
``consider, as soon as practicable, whether to suspend, revise, or
rescind, or publish for notice and comment proposed rules suspending,
revising, or rescinding, those regulations, consistent with applicable
law, including the Administrative Procedure Act.'' The memorandum
specifically directed the Department to ensure that undue restrictions
are not put on the use of Federal funds or on women's access to medical
information. After reviewing the 2019 rule, the Department went through
notice-and-comment rulemaking and finalized a regulation to revoke the
2019 rules and restore the 2000s regulation that successfully guided
the program for decades with several modifications needed to strengthen
the program and ensure access to equitable, affordable, client-
centered, quality family planning services for all clients.
Question. Chairman Pallone and I recently wrote a letter to
interested parties requesting input on how best to write legislation
establishing a public health insurance option. The objective is to
create a strong Federal public option that makes healthcare more
accessible, more affordable, and simpler for patients and families. In
addition to policies like permanently extending the increased premium
tax credits in the American Rescue Plan, a public option would go a
long way towards ensuring every person has quality, affordable coverage
regardless of income, age, race, disability, or zip code. We were
pleased that the budget expressed the President's support for a public
option available through the ACA marketplaces.
How would a public option help expand coverage, bring down
healthcare costs, and make healthcare easier to access for patients and
families?
Answer. The President supports providing Americans with additional,
lower-cost coverage choices by creating a public option that would be
available through the ACA marketplaces and giving people age 60 and
older the option to enroll in the Medicare program with the same
premiums and benefits as current beneficiaries, but with financing
separate from the Medicare Trust Fund. . President Biden has been clear
that his goals for improving the American healthcare system begin with
building on the successes of the Affordable Care Act, and HHS is
committed to working toward that goal.
Question. The Affordable Care Act (ACA) authorized $30 million for
Consumer Assistance Programs (CAPs) to provide a dedicated Federal
funding stream to help health insurance consumers effectively steer
their way through our nation's complex health insurance system and to
avail themselves of new consumer protections in the ACA. In 2010, HHS
awarded nearly $30 million in CAP grants to 40 states, territories, and
the District of Columbia. Regrettably, efforts to overturn and then
weaken the ACA resulted in blocking additional funding after the first
year. Many states--including New York, Massachusetts, Maine,
Connecticut, Rhode Island, Vermont, the District of Columbia, Maryland
and more--maintained CAPs with limited state funds, but others closed
altogether for lack of funding. These programs help consumers
understand and use their insurance plans, resolve medical billing
problems, and appeal insurance denials. As the Biden Administration
joins Congress to provide support to individuals who are underinsured
or who have lost their jobs and healthcare coverage due to the economic
downturn caused by the COVID-19 pandemic, assistance is needed to help
consumers navigate and understand their healthcare options.
Does the Administration support the resumption of the ACA CAP
programs to sufficiently meet the demand for such assistance?
How does the Administration plan to prioritize the provision of
services provided in the CAP programs to people across the nation?
Answer. HHS is committed to using all available tools to strengthen
the ACA Marketplaces, making it easier for people to get and keep
health insurance, and making sure more Americans know about their
options and are supported in their enrollment.
Question. In December 2018, the bipartisan 21st Century IDEA (PL
115-336) was signed into law. It requires agencies to modernize their
websites, intranets and digitize their paper-based forms with the goal
of improving the Federal Government's customer experience and digital
service delivery. Since Congress passed the 21st Century IDEA, the
nature of how individuals engage with the government has fundamentally
changed--in large part because of the COVID- 19 pandemic. These changes
underscore an even stronger need to implement the 21st Century IDEA and
allow Federal agencies to deliver an excellent customer experience from
anywhere, to anyone, on any device.
Has CMS fully implemented the 21st Century IDEA Act (Public Law No:
115-336)? What barriers has CMS faced in implementing this law and
modernizing its digital services?
The law required each executive agency to digitize and ensure any
paper- based form was made available to the public in a fully usable
mobile friendly option. Where does CMS stand in ensuring its forms can
be filled out and submitted electronically on all digital devices?
Who is responsible inside CMS for ensuring the agency fully
implements PL 115-336?
Answer. CMS is committed to making sure beneficiaries, enrollees,
providers, and other stakeholders have access to the information they
need to make important decisions about their healthcare. The 21st
Century IDEA provided CMS with valuable resources and guidance that
bolstered its ongoing efforts to modernize its websites. CMS has
implemented the 21st Century IDEA for all of its public websites, and
many CMS forms are available for beneficiaries, enrollees, providers,
and other stakeholders to fill out and submit online. The CMS Office of
Communications continues to make updates that make it easier to access
and submit these forms from a mobile device.
Question. HRSA's C.W. Bill Young Cell Transplantation Program,
along with its nonprofit partner the National Marrow Donor Program
(NMDP), provides support and access for patients who need lifesaving
bone marrow transplants. The President's budget request proposes to
combine the Cell Transplantation/National Registry Program with the
National Cord Blood Inventory (NCBI) Program. It also appears to
request an increase of $7 million for the Cell Transplantation/National
Registry Program.
Please provide greater detail than what was included in the HRSA
Congressional Justification (CJ) on the proposed consolidation and how
HHS plans to spend the proposed increase.
Answer. In fiscal year 2022, HHS will use approximately $49.2
million in consolidated funds from the C.W. Bill Young Cell
Transplantation Program (CWBYCTP) and the National Cord Blood Inventory
(NCBI) to support the common legislative and therapeutic functions of
both programs (i.e. bone marrow functions, cord blood functions, single
point of searching access, stem cell therapeutic outcomes database, and
patient advocacy) outlined in the TRANSPLANT ACT of 2021.
In fiscal year 2022, HHS expects to award approximately $10 million
to licensed cord blood banks to continue banking high-quality, diverse
cord blood units. HHS also plans to provide approximately $7 million to
examine ways to optimize cord blood utilization. The remaining $32.2
million will support the five legislative functions described above
through one or more contracts. HHS will obligate these funds primarily
for contract-supported initiatives (i.e. adult donor recruitment and
tissue typing, searches for stem cell sources through a single point of
electronic access, patient education, case management, donor advocacy,
public outreach, professional development, and data collection). HHS
will use a small portion for administrative costs.
Question. In addition, this Committee provided increases for this
program in both fiscal year 2200 and fiscal year 2021, yet the CJ
includes little detail on how HRSA plans to use these resources. Please
provide execution detail for each of these fiscal year increases and
the total amount that was obligated and applied to HRSA's partners who
run the program.
Answer. In fiscal year 2020, HRSA provided an increase in funding
to support new and existing activities under the Single Point of
Access-Coordinating Center contract. The activities for the Office of
Patient Advocacy and Stem Cell Therapeutic Outcomes Database contracts
remained unchanged. The funding provided for each CWBYCTP contractor is
outlined below:
--National Marrow Donor Program--
--Single Point of Access-Coordinating Center (SPA-CC)--$21.8
million used to support the SPA-CC contract, which carries
out three legislative functions (i.e., bone marrow, cord
blood, single point of access);
-- This funding included an additional $5.4 million, which
increased existing support for adult donor recruitment and
tissue typing; high-resolution tissue typing of cord blood
units and collaboration with cord blood banks to enhance
cord blood operations. The funding also supported new
activities under the contract, including: cytomegalovirus
testing of adult donors; COVID-19 related increases
including donor and courier costs; and cryopreservation of
blood stem cell products.
--Office of Patient Advocacy (OPA)--$877,000 used to support the
Office of Patient Advocacy; and
--Medical College of Wisconsin's Center for International Blood and
Marrow Transplant Research--
--Stem Cell Therapeutic Outcomes Database--$4.6 million used to
collect outcomes data on blood stem cell transplants using
bone marrow and cord blood.
In fiscal year 2021, HRSA plans to fund existing and enhanced
activities carried out by the following CWBYCTP contractors:
--Single Point of Access-Coordinating Center (SPA-CC)--$29.8 million
used to support the SPA-CC contract.
--HHS will fund many of the same activities, including adult donor
recruitment and tissue typing, high-resolution tissue typing of
cord blood units, and collaboration with cord blood banks.
Also, HHS will fund donor advocacy and contingency planning
activities.
--The additional $7 million will support existing NCBI cord blood
banks; raise physician awareness of all cellular therapy
treatment options, including cord blood; and support
engagement with the cord blood community.
--Office of Patient Advocacy (OPA)--$903,000 used to support the
patient advocacy and case management. The scope for this
contract has not increased in recent years.
--Stem Cell Therapeutic Outcomes Database--$4.7 million used to
collect outcomes data on blood stem cell transplants using bone
marrow and cord blood. The scope for this contract has not
increased in recent years.
Question. The Committee included language in the fiscal year 2021
Conference Agreement that encouraged HHS to ``review the accreditation
and eligibility requirements for the Public Health Service Corps and
behavioral health workforce programs to allow access to the best
qualified applicants, including those who graduate from Psychological
Clinical Science Accreditation System (PCSAS) programs''. This review
and these changes are necessary to update Department policy that was
adopted prior to the establishment of PCSAS to permit the graduates of
the current 44 PCSAS University accredited doctoral programs in
psychological clinical science to be eligible to compete.
Please provide an update on progress to update these Department
policy and regulation.
Answer. As of December 2020, the Public Health Service Commissioned
Corps includes the Psychological Clinical Science Accreditation System
programs in the Category Specific Appointment Standards. This means
that individuals with such accreditation are permitted into the Corps.
HRSA is currently exploring options to include PCSAS doctoral
programs as eligible entities in the upcoming fiscal year 2022 Graduate
Psychology Education competition. HRSA will continue to explore options
to include such programs in other future competitions, including, but
not limited to, the Behavioral Health Workforce Education and Training
program, and the Geriatric Academic Career Awards. HRSA currently
anticipates posting the Notice of Funding Opportunity for the Graduate
Psychology Education program in November 2021.
Question. The Centers for Medicare & Medicaid Services (CMS) posted
a final rule for Medicare's radiation oncology alternative payment
model (RO APM) on September 18, 2020. Implementation of the model has
been delayed by Congress until January 2022.
Is the Biden Administration reviewing and planning to issue an
updated RO APM?
Will HHS commit to working with both Congress and stakeholders to
improve the RO APM and ensure that a transition to new value-based
models does not result in reduced patient access to innovative cancer
treatments?
Answer. Since 2014, CMS has explored potential ways to test an
episode-based payment model for radiotherapy (RT) services. In December
2015, Congress passed the Patient Access and Medicare Protection Act,
which required the Secretary of Health and Human Services to submit to
Congress a report on ``the development of an episodic alternative
payment model'' for RT services. The report was published in 2017 and
identified three key reasons why RT is ready for payment and service
delivery reform: the lack of site neutrality for payments; incentives
that encourage volume of services over the value of services; and
coding and payment challenges.
The Radiation Oncology (RO) Model, implemented through the CMS
Innovation Center, aims to improve the quality of care for cancer
patients receiving RT and move toward a simplified and predictable
payment system. The RO Model tests whether prospective, site neutral,
modality agnostic, episode-based payments to physician group practices,
hospital outpatient departments, and freestanding radiation therapy
centers for RT episodes of care reduces Medicare expenditures while
preserving or enhancing the quality of care for Medicare beneficiaries.
I am happy to work with Congress and other stakeholders to address any
concerns about this model.
The Consolidated Appropriations Act, 2021 enacted on December 27,
2020 included a provision that prohibits implementation of the
Radiation Oncology Model prior to January 1, 2022, effectively delaying
the start date by at least 6 months. CMS intends to address the delay
and make other modifications to the RO Model through notice and comment
rulemaking.
Question. Analysis of CDC data and other reports indicate a
reduction in routinely recommended vaccination of children and youth
last year resulting from the disruption to routine healthcare caused by
the COVID-19 pandemic. Lack of proper vaccinations could provide an
additional challenge to the return to in-person learning in the fall.
How is HHS working with the Department of Education to support the
vaccination of children and youth needed for school enrollment for in-
person learning?
Answer. CDC issued a Call to Action in April 2021 encouraging
healthcare providers to identify and follow up with families whose
children have missed doses, and to schedule appointments for those
children. CDC encouraged schools and state and local government
agencies to use the state's immunization information system's reminder-
recall capacity to notify families whose children have fallen behind on
routine vaccines and encourage compliance with vaccination
requirements. In June 2021, CDC issued an MMWR article describing the
decrease in routine childhood and adolescent immunizations in 10 U.S.
jurisdictions during March-September 2020 as compared with the same
period in 2018 and in 2019.
______
Questions Submitted by Senator Richard J. Durbin
Question. Secretary Becerra, the budget proposes $767 billion for
Medicare. One of the greatest drivers of outlays by the Medicare
program is the cost of chronic conditions, including tobacco-related
costs. By some estimates, 10 percent of Medicare spending is
attributable to smoking and the health harms it causes. So it would
seem that the Department would want to be doing everything it can to
prevent tobacco use, especially among youth. As you know, youth e-
cigarette use has skyrocketed over the past decade. Four million kids
are now vaping--one in every five high school students.
And for years, the Federal Government failed to regulate these
addictive, kid-friendly products. Nine months ago, e-cigarette
companies were required to submit applications to the FDA in order to
stay on the market. This is a momentous time for the FDA, as it will
evaluate whether these e-cigarettes are ``appropriate for the
protection of public health.'' That is a high bar. But the FDA's
priority should be protecting our youth and preventing a lifetime of
addiction. I am deeply concerned that the FDA will let a product such
as JUUL--which has partnered with Marlboro-maker Altria and had a
years-long documented campaign of hooking our kids on nicotine--to
remain on the market. In particular, I am worried that FDA will allow
flavored products--which we know are meant to target kids--to
proliferate.
Can you commit to me that HHS and FDA will not authorize any vaping
products that will lead to more youth use, including flavored products?
Answer. FDA has a very important responsibility to review new
tobacco products before they can be legally marketed. FDA determines if
a new tobacco product may be legally marketed by assessing whether the
marketing of the product meets the applicable standard Congress set in
the law to protect the public health.
As required by statute, a key consideration in our review of
premarket tobacco product applications submitted for products like e-
cigarettes is to determine whether permitting the marketing of the
product would be ``appropriate for the protection of the public
health,'' taking into account the risks and benefits to the population
as a whole. This determination includes consideration of how the
products may impact youth use of tobacco products and the potential for
the products to completely move adult smokers away from use of
combustible cigarettes. Importantly, we know that flavored tobacco
products are very appealing to young people. Therefore, assessing the
impact of potential or actual youth use is a critical factor in our
determination as to whether the statutory standard for marketing is
met.
Looking forward, FDA continues to work expeditiously to complete
review of the remaining pending applications. While the Agency cannot
prejudge applications or categorically deny marketing authorization
based on certain characteristics, such as flavors, be assured that HHS
and FDA share your concern about youth initiation and use of tobacco
products, and we will continue to keep you updated as reviews continue.
Question. Two decades ago, a CDC study came out that changed the
way we think about public health. It was called the Adverse Childhood
Experiences or ``ACEs'' study, and it established the link between
exposure to trauma--things like witnessing violence or an overdose--and
our long-term health, education, and economic outlook. We now
understand how trauma and ACEs harm brain development, and how these
emotional scars can lead to lower life expectancy, and a higher
likelihood of suicide or drug use.
When you look at the public health crisis of gun violence--along
with the mental health and addiction--it's clear we must focus on the
root issue of trauma. So Senator Capito and I teamed up in 2018 to pass
legislation that created an ACEs program at CDC, and I am pleased to
have secured $10 million over the past 2 years for this work. We also
passed provisions creating the Interagency Task Force on Trauma-
Informed Care that brings our Federal agencies around the table to
promote this understanding of trauma in every Federal grant program,
increasing the authorization for the National Child Traumatic Stress
Network, and authorizing a $50 million trauma and mental health
services grant program for schools, which we have not yet been able to
fund. This grant program--Section 7134 of the SUPPORT for Families and
Communities Act--would assist schools in adopting trauma-informed
practices, training more staff, engaging families, and forging
partnerships with clinical mental health professionals.
Now, the 2022 budget proposes a $61 million increase to SAMHSA's
Project AWARE mental health funding, and a $100 million investment at
CDC in community-based violence interventions, working with
neighborhood organizations and hospitals to deliver services. Chicago
is home to many of these programs--including street outreach efforts,
trauma programming in schools, and hospital programs that pair victims
of violence with social workers to address their trauma and reduce the
current 50 percent re-injury rate.
Secretary Becerra, can you explain how this new CDC community-
violence proposal can support programs like those in Chicago, and how
you envision this constellation of programs working together?
Secretary Becerra, in addition to, or as part of, the proposed
increase to Project AWARE, would you also support appropriations for
this already-authorized Sec. 7132 program to address the breadth of
trauma needs in schools--setting up comprehensive plans, trainings, and
partnerships?
Answer. The Community Violence Initiative (CVI) proposal would help
CDC address the root causes of community violence and support systemic
approaches to violence prevention. CDC would prioritize implementing
evidence-based, community strategies to reduce rates of violence;
expand our prevention data surveillance, conduct research to address
critical gaps; and enhance what is known about what works to prevent
community violence. This approach includes prevention strategies that
address the structural determinants of health that contribute to
violence inequities within and across communities, such as those
currently implemented in Chicago. In addition, Hospital-Community
Partnerships, such as HEAL, represent an important type of strategy to
prevent and reduce community violence and could be supported under the
proposed Community Violence Initiative.
A comprehensive approach is critically important to achieving and
sustaining long-term reductions in community violence. A strong and
growing research base demonstrates that there are multiple prevention
strategies that are scientifically proven to reduce violence
victimization and perpetration. Many of these strategies are upstream
approaches that have yielded community savings that far outweigh
implementation costs. These upstream approaches, coupled with programs
like hospital-community partnerships, can create safe, healthier, and
more resilient communities.
In addition to funding 25 cities with the highest overall number of
homicides and the 25 cities with the highest number of homicides per
capita, the CVI proposal would also fund up to five non-governmental
organizations that have expertise in partnering with communities most
impacted by community violence. Doing so will build a network of
violence prevention efforts, from local health departments to community
organizations. The CVI proposal will also help modernize data systems
like the National Violent Death Reporting System (NVDRS) to provide
more timely data on causes of violence in communities.
SAMHSA is also committed to effective school based mental health
services that address the needs of children and families. Project AWARE
grantees have established mechanisms to provide tiered services in
school settings. This tiered system has three main components. One pays
attention to the overall school climate and promotes social and
emotional learning opportunities and supports for all children. The
next tier has special programming for children at risk for the
development of behavioral health conditions. The third and final tier
is comprehensive services for children and their family with serious
emotional disturbance (SED). A comprehensive approach to behavioral
healthcare in schools is critical to build resilience in our children
and youth include building trauma-informed school systems and providing
training and community partnerships in trauma-informed care. Building
in trauma-informed care to AWARE projects and augment that work with
additional partnerships to address the breadth of need in schools is
critical to meet the mental health needs of our children and youth.
Several programs funded by HRSA are focused on measuring and
addressing the impact of ACEs, as well as providing trauma-informed
care in schools.
national coordinating committee on school health and safety
HRSA in collaboration with CDC leads the National Coordinating
Committee on School Health and Safety (NCCSHS) to support student well-
being and ensure school facilities are healthy and safe environments.
Since its inception in 1996, NCCSHS aims to support communication among
governmental agencies and national non-governmental organizations in
order to share resources and disseminate information about school
health and safety to local and state partners. NCCSHS members are
working to coordinate communication and encourage uptake at the state/
local levels of school-based approaches that protect student's mental
health and well-being through expanding comprehensive, trauma-informed
mental health services in schools and the Whole School, Whole
Community, Whole Child model (WSCC). NCCSHS includes 170 members
including eight Federal agencies and non-governmental organizations
such as the American Academy of Pediatrics, American Psychological
Association, and Council of Chief State School Officers.
collaborative improvement and innovation network for school-based
health services
The Collaborative Improvement and Innovation Network for School-
Based Health Services (CoIIN-SBHS) provides trauma-informed, behavioral
health technical assistance to state partners (e.g., Title V Maternal
and Child Health programs, state Medicaid programs, child mental health
agencies, education agencies, state-level non-profit organizations),
school districts, comprehensive school mental health systems and
school- based health centers. This program is in its fifth of 5 years
of funding and is administered by the School Based Health Alliance in
partnership with the National Center for School Mental Health.
adverse childhood experiences (aces) in primary care settings
demonstration project
The newly awarded Adverse Childhood Experiences (ACEs) in Primary
Care Settings Demonstration Project will study how best to implement,
in primary care settings, screening protocols and evidence-based
interventions for children and adolescents who have experienced ACEs.
The goal of this program is to yield a model for integrating ACEs
screening and strength-based, trauma-informed services into primary
care settings. This three-year demonstration project aims to:
--Study how primary care settings can best screen and provide care to
children impacted by ACEs, including strengths, limitations,
and implementation challenges; and
--Produce a scalable model that can help pediatric providers
effectively integrate screening with strength-based, trauma-
informed care and services in primary care settings.
National Survey of Children's Health:
The National Survey of Children's Health (NSCH), funded and
directed by HRSA's Maternal and Child Health Bureau, is the nation's
largest annual survey of children's health at the state and national
levels.
This parent-reported survey includes questions to assess a range of
Adverse Childhood Experiences (ACEs) among U.S. children.
Data from 2019-2020, show that 21.7 percent of U.S. children ages
0-17 had experienced one ACE in their lifetime, while 18.1 percent had
experienced two or more ACEs. Data from the 2021 NSCH will be released
on October 3rd, 2022.
Question. Secretary Becerra, the United States is world's largest
importer of personal protective equipment. Three-quarters of N95 masks
in the U.S. are produced overseas, the majority from China. And from
2019 to 2020, American imports of PPE from China skyrocketed from $2
billion to $14 billion. This created shortages and price spikes--
resulting in those horrific images of our health heroes wearing garbage
bags to stay safe. 80 percent of nurses reported re-using masks meant
for single use. When it came to our prized Federal backstop--the
Strategic National Stockpile--the supply was inadequate. 5 million N95
masks in the Stockpile were expired. Governors only got a fraction of
the masks, gowns, and gloves they asked for.
Senator Cassidy and I have introduced the PPE in America Act to
boost domestic manufacturing of PPE and medical supplies so we no
longer have to rely on China and others to keep our health workers
safe. Our bill would use the purchasing power of the Stockpile as an
engine to sustain domestic PPE manufacturers. And it would enable a
replenishable, churning mechanism for the Stockpile to routinely sell
supplies to other agencies, states, and the commercial market . . . and
re-stock equipment from domestic producers. This arrangement will
provide predictability that domestic PPE manufacturers can depend on .
. . and will improve their coordination with the Stockpile to avoid
expiration of supplies.
Secretary Becerra, I'm pleased to see the budget proposes a $200
million increase for the Stockpile. Do you support policies that boost
domestic PPE production, mitigate risk for expiration, and provide
sustainability for manufacturers, including through replenishing
mechanisms for the SNS?
Answer. The global pandemic has highlighted the vulnerabilities of
the global supply chain. It is critical that steps are taken to invest
in expansion of U.S. domestic manufacturing capacity. To that end, the
Office of the Assistant Secretary for Preparedness and Response (ASPR)
is leveraging the authorities delegated to the Secretary under the
Defense Production Act (DPA) to ensure that private sector partners
making life-saving products are able to acquire raw materials, retool
their machinery, scale their production facilities, train their
workforces, and ultimately deliver their product. Throughout the COVID-
19 response, ASPR has used the DPA authority to issue 46 priority
ratings for United States Government (USG) contracts for health
resources, eight priority ratings for USG contracts for industrial
expansion, and 3 priority ratings for non-USG contracts to indirectly
support COVID-19 and/or mitigate the potential stockout of critical
lifesaving therapies. Going forward, ASPR will continue to build
capacity and partnerships with private industry toward the shared goal
of ending the COVID-19 pandemic and preparing for future pandemics.
ASPR is also working to support efforts in expanding the domestic
industrial base. These industrial base expansion (IBx) efforts seek to
reduce supply chain vulnerabilities and generate a domestic ``warm-
base'' for manufacturing that can be leveraged in a crisis. During the
COVID-19 pandemic, all contracts--competitive and sole-sourced--awarded
by the Department of Health and Human Services for N95 respirators were
for U.S.-produced supplies. A total of approximately 800 million
domestically produced N95 respirators were procured for the Strategic
National Stockpile. Contracting actions executed in March 2020 were
intended to encourage manufacturers to immediately increase production
of N95 respirators, and these manufacturers with domestic production
capabilities stepped up to support the nation with quality products at
the best prices for the USG. Furthermore, with $10 billion received for
emergency medical supplies enhancement, ASPR has been establishing and
maintaining domestic capacity for critical supplies.
Lastly, ASPR's Hospital Preparedness Program (HPP) included two
requirements in the fiscal year 2019-2023 funding opportunity
announcement to help address supply chain vulnerabilities. First, HPP
recipients and their healthcare coalitions must conduct a supply chain
integrity assessment to evaluate equipment and supplies that will be in
demand during emergencies and develop mitigation strategies to address
potential shortfalls. Second, each healthcare coalition must update and
maintain a regional resource inventory assessment.
ASPR will continue to assess and monitor domestic manufacturing
capabilities going forward. As the COVID-19 pandemic continues, we will
modify and refine efforts, as needed, to ensure they do not interfere
with the private sector but support efforts to maintain and build a
robust domestic capability.
Question. One of the major lessons learned from the pandemic was
the need to bolster our healthcare workforce. But this is not a new
problem. Even before COVID-19, our nation faced a shortfall of 120,000
doctors and a quarter-million nurses, with many rural and urban areas
facing recruitment challenges. Across Illinois, 5 million people live
in shortage areas for mental health providers, 3 million with too few
primary care doctors. The problem starts with medical education in
America. We take promising students, put them through years of rigorous
education and training, and license them on one condition: student loan
debt that can average more than $200,000. The burden of paying off
these loans steers our brightest minds into higher- paying specialties
and more affluent communities. This is especially true for healthcare
providers of color. You may be aware there are fewer Black men entering
medical school today than there were in the 1970s. Black and Latinx
Americans make up 31 percent of the nation's population, yet just 6
percent of doctors. We know that this discrepancy leads to worse care
and outcomes for patients of color.
Thankfully, the National Health Service Corps helps to address
these gaps by providing scholarship or loan repayment for healthcare
workers who commit to serve in urban and rural areas with shortages.
President Biden's American Rescue Plan included a provision I authored
with Senator Rubio to provide $1 billion in loan repayment and new
scholarship awards to the National Health Service and Nurse Corps. It
will help surge tens of thousands of new clinicians into under-served
areas, representing the largest single-year appropriation to our
healthcare pipeline in history. We know that scholarship-based awards
can make a particularly meaningful difference when it comes to
emphasizing recruitment from under-represented populations.
The pandemic has also magnified acute workforce shortages in
communities facing natural disasters or other public health
emergencies. The GAO has recently reported on how the National Disaster
Medical Service--which activates health personnel from private
practices for deployment intermittent Federal employees--does not have
the planning in place to ensure a workforce capable of responding to
nationwide or multiple concurrent health events, and that its workforce
is only a fraction of its target level. I have introduced legislation
with Senator Rubio (S.54, the Strengthening America's Health Care
Readiness Act), to test a pilot program that provides supplemental loan
repayment for NHSC alumni who continue to practice in a shortage area,
and current NHSC clinicians, who concurrently serve in the NDMS and are
available for rapid, short-term deployment for health emergencies.
Under this pilot program, HRSA and ASPR would have the authorities and
directive to coordinate to ensure adherence to their core missions and
the appropriate application of NHSC contract requirements and covered
benefits/protections of NDMS employment. I have also introduced
legislation with Senator Blackburn (S.924, Rural America Health Corps
Act), to increase recruitment and retention of NHSC clinicians in rural
areas, given the fact that only 5 percent of incoming medical students
hail from rural areas and one-third of placements are in rural
communities. This legislation would test a pilot program to explore
whether an elongated service commitment and increased loan repayment
award--5 years and $200,000--could enhance recruitment and retention in
rural America.
Secretary Becerra, your budget proposes a $47 million increase to
the National Health Service Corps. Do you support using appropriations
for certain pilot program approaches that test and evaluate new
strategies to address specific nuances and acute gaps in our country's
health workforce needs, including in health preparedness, health
disparities, and in rural America?
Answer. HRSA will implement the programs that Congress enacts. The
aim of National Health Service Corps (NHSC) is to address the primary
care needs of underserved populations and to provide them with access
to quality healthcare. The $47 million request for the NHSC will be
dedicated to bolstering the health workforce in rural and underserved
communities where there is an existing shortage of primary care
providers. Similar, in part, to the goals of the Rural America Health
Corps Act, the proposed funding will expand access to primary care
services to vulnerable populations, specifically those areas facing
barriers to obtaining evidence-based substance use disorder (SUD)
treatment services. The NHSC Rural Community Loan Repayment Program
(LRP), SUD Workforce LRP, and the traditional NHSC LRP will serve as
the mechanisms for distributing this requested funding, as these
programs have proven their effectiveness in mobilizing and retaining
providers in the areas where they are needed most. A total of 28,405
clinicians in the NHSC and Nurse Corps completed their service between
2012 and 2019; of these, 80 percent continue to serve in Health
Professional Shortage Areas (HPSAs) after their service obligation is
completed. One out of three of those NHSC alumni work in rural
communities. Over the same timeframe, 78 percent of the NHSC
participants who completed their service obligation at a site in a
rural area continue to work in a rural area, with over 50 percent
continuing to work in a HPSA in the same county where they completed
their NHSC service.
The Hospital Preparedness Program (HPP) supports efforts to
strengthen healthcare sector readiness to provide coordinated, life-
saving care in the face of emergencies and disasters. The HPP portfolio
supports a comprehensive, national network for healthcare preparedness
and response. The programs and activities within the HPP portfolio are
coordinated to address the many, complex facets of the nation's
healthcare system, creating mechanisms and infrastructure to improve
coordination between localities, states, and regions, as well as
developing new capabilities (e.g., telemedicine, specialty healthcare,
etc.) specific to key challenges within the modern threat landscape
(e.g., highly pathogenic disease; biological/chemical incidents, etc.).
As the primary source of Federal funding for healthcare system
preparedness and response, HPP promotes a consistent national focus to
improve patient outcomes during emergencies and to enable rapid
healthcare service resilience and recovery. Since 2002, investments
administered through HPP have improved individual healthcare entities'
preparedness and have built a system for coordinated healthcare system
readiness and response through healthcare coalitions (HCCs) and other
partnerships, such as the Regional Disaster Health Response System
(RDHRS) demonstration project. With respect to infrastructure needs,
recipients of funding are expected to consider how to provide and plan
for uninterrupted care when faced with damaged or disabled healthcare
infrastructure during an emergency response; however, the HPP
cooperative agreement does not allow for construction or major
renovation costs.
HPP provides cooperative agreement funding to states to support
healthcare system preparedness efforts. Specific to Colorado, if
appropriated at the requested level in fiscal year 2022, it is
estimated that Colorado will receive $3,584,461 via the HPP cooperative
agreement. Colorado will delegate this funding within the state to
support such efforts, including enhancing rural capabilities.
--Additional ASPR Programs and Tools Concerning Colorado and Rural
Health:
--The Denver Health and Hospital Authority was also recently
awarded the Partnership for Disaster Health Response System
Cooperative Agreement to establish the Region 8 Mountain
Plains RDHRS demonstration site. To address gaps in
regional healthcare delivery during disasters, ASPR
developed the RDHRS: a tiered system that builds upon and
unifies existing healthcare and ASPR assets within states
and across regions that supports a more coherent,
comprehensive, and capable healthcare disaster response
system able to respond to health security threats. The
RDHRS helps improve disaster readiness capabilities and
capacity, increase medical surge capacity, and extend
provision specialty care--including trauma, burn and
infectious disease, among others--during large-scale
disasters or public health emergencies.
--Additionally, the Rural Health Care Surge Readiness Portal was
established in 2020 to provide the most up-to-date and
critical resources for rural healthcare systems preparing
for and responding to a COVID-19 surge. The resources span
a wide range of healthcare settings (including EMS,
inpatient and hospital care, ambulatory care, and long-term
care) and cover a broad array of topics ranging from
behavioral health to healthcare operations to telehealth.
This portal was developed by the COVID-19 Healthcare
Resilience Working Group, a partnership with the U.S.
Department of Health & Human Services, the U.S. Department
of Homeland Security, and other Federal agencies, to
provide support and guidance for healthcare delivery and
workforce capacity and protection.
______
Questions Submitted by Senator Jack Reed
Question. My colleague on the LHHS Subcommittee, Sen. Capito, and I
authored the Childhood Cancer Survivorship, Treatment, Access, and
Research (STAR) Act--the most comprehensive childhood cancer bill in
history--which was signed into law on June 5, 2018 (Public Law No: 115-
180). Every year since becoming law, Congress has provided full funding
($30 million) to support the programs created by the STAR Act. However,
two provisions remain to be implemented: Title 2, Section 201(a), which
requires the Secretary of Health and Human Services to make awards to
establish pilot programs to develop, study, or evaluate model systems
for monitoring and caring for childhood cancer survivors throughout
their lifespan, including evaluation of models for transition to adult
care and care coordination; and Title 2, Section 201(b), which requires
the Secretary to conduct a review of HHS activities related to
workforce development for healthcare providers who treat pediatric
cancer patients and survivors and to report the findings within 2 years
of the enactment of the STAR Act.
Could you provide a status update on the implementation of these
two key provisions of the STAR Act?
Answer. Senator Reed, first, thank your sponsorship of the
Childhood, Cancer Survivorship, Treatment, and Research Act (STAR Act).
The STAR Act enhances the research on the late effects of childhood
cancers and is a critical step toward improving the quality of life for
survivors of childhood cancer. The Agency for Healthcare Research and
Quality (AHRQ) has partnered with the National Cancer Institute (NCI)
to commission three evidence reports as part of the Department's
response to the two provisions of the Act that you reference: Section
201(a) and 201(b).
--Disparities and Barriers to Pediatric Cancer Survivorship Care
(https://effectivehealthcare.ahrq.gov/products/pediatric-
cancer-survivorship/research). The report was posted on the
AHRQ for public comment in October 2020, with simultaneous peer
review and the final report was published March 1, 2021.
--Findings from the report were presented on April 20, 2021 on a
free NCI- sponsored webinar. The recording can be found at
https://cancercontrol.cancer.gov/ocs/events/disparities-
and-barriers.
--A manuscript titled ``Interventions to address disparities and
barriers to pediatric cancer survivorship care: a scoping
review'' derived from the report was published in the
Journal of Cancer Survivorship on June 16, 2021.
--Findings from the technical brief were presented at University of
Cincinnati Hematology-Oncology Grand Rounds (5/28/2021); MD
Anderson Cancer Survivorship Grand Rounds (6/18/2021);
Cancer Support Community Seminar (7/27/2021); and the
University of Kentucky Markey Cancer Center Affiliate
Network's 15th Annual Cancer Care Conference (9/30/2021).
The NCI used the findings of the report to provide administrative
supplements for the ``NCI P30 Cancer Center Support Grants'' to support
research to understand and address organizational factors that
contribute to disparities in outcomes among childhood cancer survivors.
Additionally, this report has already begun to inform the broader
cancer survivorship research community and survivorship care providers
based on dissemination of the review findings.
--Models of Care That Include Primary Care for Adult Survivors of
Childhood Cancer (https://effectivehealthcare.ahrq.gov/
products/pediatric-adolescent-cancer-survivorship/protocol).
This report was posted on the AHRQ website for four weeks of
public comment in June 2021, with simultaneous peer review. The
report is now being finalized. The final report is expected to
be shared with NCI and publicly posted by the end of 2021.
AHRQ and NCI expect to widely disseminate this report to the
research community and the general public once it can be
publicly posted to raise awareness of the role that primary
care providers can play in the care of adult survivors of
childhood cancer. The NCI also plans to use the findings of
this report to evaluate its current grant portfolio, to
identify and assess potential gaps and opportunities for
additional research on this topic.
Transitions of Care from Pediatric to Adult Services for Children
with Special Healthcare Needs (https://
effectivehealthcare.ahrq.gov/products/transitions-care-
pediatric-adult/protocol). The draft report was posted on
AHRQ's website in September 2021 for four weeks of public
comment and simultaneously underwent peer review. A final
report will be shared with NCI and posted publicly in 2022.
Similar to the Models of Care report, AHRQ and NCI expect to widely
disseminate this report to the research community and the
general public once it can be publicly posted to raise
awareness of challenges in transitioning care from pediatric to
adult services for children with special healthcare needs. This
report is expected to serve as a resource for those with
interests related to a number of serious healthcare diseases
and conditions including cancer. The NCI also plans to use the
findings of this report to evaluate its current grant
portfolio, to identify and assess potential gaps and
opportunities for additional research on this topic.
______
Questions Submitted by Senator Jeanne Shaheen
Question. While I am pleased that we've made so much progress on
vaccinations and getting through this pandemic, I continue to hear from
hospitals and nursing homes in New Hampshire that are running on tight
budgets after significant financial losses due to the pandemic. In
particular, many of these hospitals and nursing homes are located in
southern New Hampshire counties that were left behind in previous
rounds of the Provider Relief Fund. These providers did not qualify for
previous rural-focused rounds of the grants, despite treating
significant portions of patients from surrounding counties that are
rural. To help address that, we worked to give HHS more flexibility to
make these types of hospitals and nursing homes eligible for the $8.5
billion in Provider Relief Fund grants from the American Rescue Plan
Act of 2021.
Do you have an update that you can share on the plans that HHS has
for the remaining Provider Relief Fund grants that have not yet been
awarded?
Answer. HHS is committed to distributing the remaining provider
relief payments as quickly, transparently, and equitably as possible
while utilizing effective safeguards to protect taxpayer dollars. HHS
is planning for future Provider Relief Fund (PRF) allocations,
including the $8.5 billion from American Rescue Plan Act and Phase 4 of
the General Distribution.
HHS is actively considering feedback from stakeholders, as well as
operational lessons learned from prior PRF payments, as part of the
planning process. The feedback from Members of Congress and other
stakeholders informs HHS' ability to administer the PRF in a manner
that bolsters the healthcare system and helps providers experiencing
COVID-related financial hardships during this crisis. HHS will publish
additional information on future distributions on the Health Resources
and Services Administration's PRF webpage, at www.hrsa.gov/provider-
relief, as soon as it becomes available.
Question. I am pleased that the President has announced his
intention to resettle 62,500 refugees in the second half of this fiscal
year. However, the enormous cuts to refugee resettlement over the past
4 years under the previous Administration have severely decimated the
U.S. Refugee Admissions Program's capacity to provide local support for
newly arrived refugees. Local resettlement agencies face substantial
challenges as they work to restore their staffing and the services they
provide, and they need timely support in order to hire and train the
new staff necessary to meet the needs of increased numbers of newly-
arrived refuges.
What specific measures are you taking to help resettlement agencies
bolster capacity and prepare for the increased rate of refugee arrivals
in the second half of this fiscal year?
Answer. The President's fiscal year 2022 budget request includes an
increase of $515 million over the fiscal year 2021 enacted level for
Refugee and Entrant Assistance programs to accommodate the expected
increase in arrivals through the end of this calendar year and beyond.
This request would support a total of up to approximately 214,000
arrivals in fiscal year 2022, including up to 125,000 refugees as well
as other entrants, such as asylees, Cuban and Haitian entrants, and
Special Immigrant Visa holders.
This includes more than doubling the Refugee Support Services
program, from $207 million in fiscal year 2021 to $450 million in the
fiscal year 2022 Budget. This is one of the major sources of funding
for resettlement agencies to bolster their capacity.
In addition to the potential budgetary support, ORR has taken
several programmatic steps to ensure that the resettlement network is
prepared for an increase in refugee and other ORR-eligible arrivals.
ORR conducted listening sessions in the spring of 2021 to better
understand current state and local capacity to resettle refugees, plans
to increase resettlement capacity, and barriers to such growth. ORR and
the Department of State/PRM conducted a joint training for State
Refugee Coordinators to ensure understanding of their role in local
capacity planning.
ORR and PRM are exploring options to strengthen policy and practice
for the required community consultations, as well as private
sponsorship. ORR staff are conducting coordinated outreach with other
Federal agencies to ensure access to mainstream benefits and services.
We are also planning for enhancements to existing services such as
mental health, employer engagement, youth and family literacy,
Preferred Communities and Matching Grant in anticipation of increased
arrivals.
Question. Does ORR anticipate being able to provide forward funding
to refugee resettlement agencies, so they have the advance funding
necessary to build capacity in anticipation of the increased rate of
refugee arrivals?
Answer. ORR continues to provide support and guidance to its
partners and anticipates being able to provide sufficient forward
funding through the President's fiscal year 2022 budget request.
______
Questions Submitted by Senator Brian Schatz
Question. In the hearing, you agreed that Congress should move
forward with legislation to expand telehealth coverage in Medicare and
committed that you would work with Congress to provide the necessary
data and technical assistance to enact telehealth legislation this
year. You also stated that you need ``greater accountability'' and
``better authority.''
What authority to ensure accountability and put safeguards into
place for telehealth services does HHS need that it does not already
have?
What measures to ensure accountability does HHS plan to put into
place when Congress expands coverage of telehealth services?
What has the HHS Office of Inspector General determined about
concerns related to fraud, waste, and abuse associated with expanded
utilization of telehealth during the COVID-19 pandemic?
Last July, ASPE released early data on Medicare beneficiary use of
telehealth. Is HHS planning to release additional data on the use of
telehealth in Medicare during the pandemic?
What is the expected timeframe on the study that CMS has
commissioned on the telehealth flexibilities during the COVID-19
pandemic?
What Center for Medicare and Medicaid Innovation (CMMI) models
include telehealth waivers, and what are those waivers for? For each
waiver, please specify how many model participants have elected the
waiver and how many beneficiaries have used telehealth services under
the waiver.
In which CMMI models have waivers enabled healthcare professionals
other than physicians and practitioners to furnish telehealth services,
and how many participants have used those waivers?
A 2018 OIG report recommended that CMS offer education and training
sessions to practitioners on Medicare telehealth requirements. How has
CMS addressed this recommendation?
Answer. Telehealth is an important tool to improve health equity
and improve access to healthcare. Healthcare should be accessible, no
matter where you live. HHS continues to examine the telehealth
flexibilities developed for the current public health emergency and
determine how we can build on this work to improve health equity and
improve access to healthcare. An HHS study released by ASPE has shown
that massive increases in the use of telehealth helped maintain some
healthcare access for Medicare beneficiaries during the pandemic. CMS
also released a data snapshot showing increases in Medicare
telemedicine utilization during the pandemic. Lessons learned from CMS
Innovation Center models also provide valuable insight into how
providers furnish high-value care and innovate in care delivery,
including the use of telehealth. In addition to looking at which
flexibilities HHS can and should continue administratively, I look
forward to working with Congress to address changes that may need to be
done through legislation.
HHS is also dedicated to making sure providers are aware of the
telehealth options available to them as they treat their patients. CMS
routinely educates practitioners through various channels, including
the Medicare Learning Network, weekly electronic newsletters, and
quarterly compliance newsletters. CMS will continue to use channels
such as these to educate and provide training sessions for
practitioners on Medicare telehealth requirements and related
resources.
ASPE/HHS is currently preparing a follow-up issue brief on Medicare
FFS beneficiary use of telehealth compared with in-person visit trends
in 2020 which will examine telehealth use by beneficiary
characteristics including race/ethnicity, urban/rural geography, state,
visit type (primary care, specialist, mental health. The brief will
also examine various telehealth modalities, including audio-only
visits, telecommunications in addition to two-way interactive video-
based telehealth visits and whether the beneficiary was located at home
or in a health-care setting for the telehealth visit. This issue brief
is anticipated to be published later this fall.
OIG is conducting significant oversight work (8 ongoing audits and
studies) assessing telehealth services during the public health
emergency. Once complete, these reviews will provide objective,
independent findings and recommendations to policymakers and other
stakeholders regarding the effect that the public health emergency
flexibilities had on telehealth. This work will help HHS ensure the
potential benefits of telehealth are realized for patients, providers,
and HHS programs without being compromised my fraud, abuse, or misuse.
OIG anticipates the first telehealth work products to be published this
fall.
Question. The Bipartisan Budget Act of 2018 authorized Medicare
Advantage plans to offer additional telehealth benefits in their annual
bid amount beyond eligible telehealth services under Medicare fee-for-
service.
What percentage of plans have offered additional telehealth
benefits?
What type of additional telehealth benefits have been offered
(i.e., types of services, types of healthcare professionals, etc.)?
Has HHS determined if there are any concerns related to fraud,
waste, and abuse associated with additional telehealth benefits in
Medicare Advantage plans?
Answer. Beginning in plan year 2020, Medicare Advantage plans have
been permitted, but not required, to offer additional telehealth
benefits as part of the basic benefit package beyond what is allowable
under the original Medicare telehealth benefit. These benefits can be
available in a variety of places, and people with Medicare Advantage
plans can use them at home instead of going to a healthcare facility.
For plan year 2021, over 94 percent of Medicare Advantage plans offered
additional telehealth benefits reaching 20.7 million beneficiaries.
Medicare Advantage plans have the flexibility to determine which
services are clinically appropriate to furnish through additional
telehealth benefits on an annual basis, consistent with the limits in
statute and regulations. For example, a Medicare Advantage plan may
offer a dermatology exam using store-and-forward technology.
All Medicare Advantage plans are required to have an effective
program to prevent, detect, and correct Medicare Advantage
noncompliance and fraud, waste, and abuse. HHS is committed to
oversight of plan compliance with this requirement while ensuring
access to care for Medicare Advantage enrollees through additional
telehealth benefits.
Question. In January, HHS said that the COVID-19 public health
emergency declaration would likely be in place for all of 2021.
As we are now halfway through 2021, does HHS have an updated
expectation for how long the public health emergency will last?
What are the factors you are considering for when the public health
emergency could be declared over (i.e., vaccination rates, daily cases,
etc.)?
Answer. The Secretary of Health and Human Services may, under
section 319 of the Public Health Service (PHS) Act, determine that: (a)
a disease or disorder presents a public health emergency (PHE); or (b)
that a public health emergency, including significant outbreaks of
infectious disease or bioterrorist attacks, otherwise exists. If and
when declared, a PHE lasts until the Secretary declares that the
emergency no longer exists or for 90 days, whichever comes first, but
it may be extended for additional 90-day periods as needed and as
determined by the Secretary.
HHS will continue to evaluate the infection rate of COVID-19 and
will modify the PHE, as needed, when cases decrease and the authorities
under a PHE are no longer needed to support response operations.
Question. In the hearing, you agreed that it would be helpful for
Federal response agencies, such as CDC, FDA, and NIH to be able to
respond proactively to public health emergencies before they get out of
control.
Would automatic funding to the Public Health Emergency Fund upon
the declaration of certain public health emergencies--including
infectious disease outbreaks--modeled after FEMA's Disaster Relief
Fund, be helpful to ensure a quick and effective response to public
health emergencies?
Answer. A key lesson learned during the ongoing COVID-19 pandemic
is that having available funding in the Public Health Emergency Fund
would ensure that HHS can immediately respond while working in
partnership with Congress on broader supplemental needs. For example,
during the initial days of the COVID-19 pandemic, the Biomedical
Advanced Research and Development Authority (BARDA) shifted program
funds and redirected contracts from some of its investments in emerging
infectious diseases (Zika and Ebola contracts) and leveraged pandemic
influenza preparedness contracts to support vaccine and therapeutic
development efforts. The funds were used to start a few critical
programs early on; however, there were insufficient funds available to
start the multi-pronged approach that led to success in both the
vaccine and therapeutic development efforts. Using funds planned for
other programs impacted the long-term investments that were in place
for other identified threats, and there is no guarantee in a future
public health emergency, that it would be possible to similarly shift
program funds.
If funded, the Public Health Emergency Fund would ensure that HHS
could take immediate action to respond to a public health emergency
before Congress enacts supplemental funding legislation. Immediate
action can reduce the overall societal and economic impact of the
public health emergency, reduce the lead time for development of
supporting resources (e.g., medical countermeasure development if
needed), and ultimately result in less overall expenditures if
potential threats are quickly contained.
Question. The pandemic has illustrated that Native communities
often do not have access to the same resources that other communities
do. For example, IHS-funded Tribal epidemiology centers are public
health authorities, but do not have access to CDC public health
authority data. And HHS agencies do not often work with states and
other public health authorities to improve data collection to allow for
disaggregation of American Indian/Alaska Native/Native Hawaiian
information.
How will you ensure that Native health systems, especially Native
public health systems, have parity access to HHS resources going
forward?
What steps is HHS taking to include Native Hawaiians, who are too
often overlooked and left out, in HHS programs and initiatives?
Answer. Regarding your question about Native health systems, the
HRSA funding opportunities for which tribes and tribal organizations
were eligible to compete, as well as awards to tribes and tribal
organizations have expanded.
HRSA's Office of Intergovernmental and External Affairs leads the
agency's Tribal Affairs, participates in HHS Tribal Consultations, and
collaborates with IHS and other Federal and community stakeholders to
address tribal issues. In response to tribal requests, the HRSA Tribal
Advisory Council is being established to provide advice on how HRSA
programs can better address tribal needs. HRSA IEA regional offices
regularly communicate with tribal leaders to respond to issues and
ensure they are aware of HRSA funding opportunities, program updates,
and technical assistance.
In fiscal year 2020, tribes and tribal organizations were awarded
more than $16 million from Rural Tribal COVID-19 Response Program. The
awards were distributed to 57 recipients across 22 states.
Additionally, in fiscal year 2020, the Health Center Program
awarded grant funding as further described below for Tribal/Urban
Indian health center organizations.
--Awarded nearly $88 million in annual operational grant funding to
35 health center organizations operating over 250 service
delivery sites serving Native communities across the U.S.
--Awarded over $2.3 million to Tribal/Urban Indian health centers to
support infrastructure needs related to disaster response and
recovery efforts.
--Awarded $31 million in Health Center Program supplemental funding
to Tribal/Urban Indian health centers to support efforts to
address the impact of the COVID-19 pandemic.
Below are fiscal year 2021 Health Center Program actions related to
health centers that are tribes or tribal organizations providing health
services within Native American communities:
--Continued annual health center operating grants, totaling
approximately $88 million for 35 health center organizations.
--Awarded $60 million to 35 Tribal/Urban Indian health centers, as
part of the American Rescue Plan Act awards. Health centers use
the funds to support and expand COVID-19 vaccination, testing,
and treatment for vulnerable populations; deliver needed
preventive and primary healthcare services to those at higher
risk for COVID-19; and expand health centers' operational
capacity during the pandemic and beyond, including modifying
and improving physical infrastructure and adding mobile units.
This investment will help increase access to vaccinations among
hard- hit populations, and increase confidence in the vaccine
by empowering local, trusted health professionals in their
efforts to expand vaccinations.
--In fiscal year 2021, HRSA and the Centers for Disease Control and
Prevention launched the Health Center COVID-19 Vaccine Program
to allocate COVID-19 vaccines to HRSA-supported health centers
directly. The program ensures our nation's underserved
communities and those disproportionately affected by COVID-19
are equitably vaccinated against COVID-19. HRSA invited all
HRSA funded health centers to participate in the program,
including the 35 Tribal/Urban Indian health centers. Eight
tribal organizations have set up accounts to participate in the
Health Center COVID-19 Vaccine Program. Six of the eight tribal
organizations have placed at least one order through the
program.
--In late September 2021, HRSA expects to announce approximately $1
billion in awards supporting health center construction,
expansion, alteration, renovation, and other capital
improvements to modify, enhance, and expand healthcare
infrastructure.
HRSA projects that 32 grants totaling approximately $18 million
will be awarded to Tribal/Urban Indian health centers through this
funding opportunity.
native hawaiian health care systems
In fiscal year 2021, HRSA provided $20.5 million in grants and
scholarship awards to Native Hawaiian Health Care Systems to improve
the provision of comprehensive disease prevention, health promotion,
and primary care services to Native Hawaiians.
Additionally, in fiscal year 2021, HRSA provided $20 million under
the American Rescue Plan Act to Native Hawaiian Health Care Systems to
aid their response to COVID-19. The awards provided six Native Hawaiian
Health Care Improvement Act (NHHCIA) recipients resources to strengthen
vaccination efforts, respond to and mitigate the spread of COVID-19,
and enhance healthcare services and infrastructure in their
communities.
technical assistance--health centers located in hawaii
HRSA continues to make technical assistance available for Hawaii
health centers to identify and address the primary healthcare needs of
their target communities and populations, and to aid in identifying
Federal programs to support those efforts. HRSA IEA Region 9 Office can
assist Hawaii stakeholders with technical assistance and other HRSA
resources.
______
Questions Submitted by Senator Joe Manchin, III
Question. Secretary Becerra, as you may be aware, Federal data
shows that more than 1.5 million students experienced homelessness in
the 2017-2018 school year, and in my home state of West Virginia, we
had well over 10,000 students identified as homeless during the 2019-
2020 school year alone. Unfortunately, identification and reporting
challenges have existed for years, and when you couple those existing
challenges with the COVID-19 pandemic- we can only expect these numbers
will be far greater than pre-pandemic levels. The Administration of
Children and Families (ACF) is tasked with promoting the economic and
social well-being of families and children, including those
experiencing homelessness. That is why, in the height of the pandemic,
I worked alongside Senator Murkowski and others to introduce the
Emergency Family Stabilization Act; that would have created a dedicated
funding stream through ACF to assist children, youth, and families
experiencing homelessness during the COVID-19 pandemic. While I was
able to work with my colleagues to secure dedicated funding through the
Department of Education for identifying and assisting children and
youth experiencing homelessness, it is not a permanent solution and
does not incorporate the all the needed resources to address the issue.
In recognizing the pandemic has greatly increased the need for
better access to services for children, youth, and families
experiencing homelessness; how does the President's budget further
improve resources for those charged with identifying and connecting our
children and youth experiencing homelessness with the services provided
by ACF?
Answer. The Administration for Children and Families receives
funding, through the Runaway and Homeless Youth Act (RHYA), to provide
services and resources to youth experiencing homelessness. Through the
Family and Youth Services Bureau (FYSB), ACF funds a National
Communications System (NCS), which is a national, toll-free, runaway
and homeless youth crisis hotline to assist runaway and homeless youth,
and those at risk of running away, in communicating with their families
and with service providers. The NCS includes telephone, Internet,
mobile applications, and any technology-driven services used for
runaway and homeless youth or youth who are at risk of running away.
The NCS provides crisis intervention, referral services, information,
and prevention resources to youth at risk of separation from their
families, runaway and homeless youth, their families, legal guardians,
and service providers.
The RHYA also authorizes the Runaway and Homeless Youth Training &
Technical Assistance Center (RHYTTAC) to provide training and technical
assistance to RHY program-funded grantees and allied professionals.
RHYTTAC assists these organizations in developing effective approaches
for serving runaway and homeless youth, accessing new resources to
enhance their ability to serve these youth, and establishing linkages
with other programs with similar interests and concerns. RHYTTAC also
helps to ensure that grantees have effective interventions in place to
build skills and capacities that contribute to the healthy, positive,
and productive functioning of children and their successful transition
from youth into adulthood.
The President's fiscal year 2022 Budget proposed to fund RHY
programs at a level of $144,987,000, which would be an increase of
$8.2M from the fiscal year 2021 appropriation level. With the proposed
increase, ACF/FYSB will seek to increase the number of RHY grantees and
continue to support training and technical assistance. ACF commits to
working with other Federal youth-serving agencies to increase awareness
of resources available through RHY Programs, and to further develop
coordinated efforts to support prevention, outreach, engagement, and
timely referral to ACF services as well as services available from
other Federal agencies. Additionally, Head Start and Child Care
Development Fund (CCDF) Block Grants also serve families with young
children experiencing homelessness.
Question. During the COVID-19 pandemic, rural health providers have
been hit hard. Last year alone, West Virginia had three hospitals
close, putting patients at risk of accessing care. In response Congress
passed $8.5 billion in the American Rescue Plan aimed at supporting
rural health providers. Since this was signed into law, HHS has made no
announcements on the plan to distribute this funding, yet rural health
providers remain at risk.
When will this funding begin to be allocated to our rural
communities?
Answer. HHS is working to finalize the $8.5 billion in American
Rescue Plan Act of 2021 funding for rural Medicare and Medicaid
providers and suppliers. HHS is considering operational lessons learned
from prior Provider Relief Fund (PRF) payments, as well as feedback
from Members of Congress and other stakeholders.
Question. During the previous Administration, determining the
status of the Provider Relief Fund was nearly impossible to do. Will
you commit to ensuring transparency when distributing this $8.5 billion
for rural providers?
Answer. HHS is committed to an equitable, transparent, and
responsive approach when distributing future provider relief payments.
HHS has listened to stakeholder input and feedback and is committed to
ensuring equity in future PRF distributions, better support to
providers applying for funds, and transparency in communication to
providers. Furthermore, the Administration is committed to building a
strong working relationship with Congress going forward and plans to
provide periodic updates on the distribution of $8.5 billion for rural
providers.
Question. The COVID-19 pandemic had significant impacts on rural
communities in West Virginia, who were already at a disadvantage when
it comes to accessing healthcare services. We have seen exponential
growth in telehealth adoption across Americans of all ages, locations,
and conditions to help address these disparities. Telehealth is a
lifeline to countless patients and their doctors in my state of West
Virginia. Telehealth among Medicare beneficiaries has been made
possible by temporary flexibilities in place for the duration of the
public health emergency. You have previously committed to work to
expand certain telehealth policies after the end of the public health
emergency. And we have learned and seen in practice that telehealth has
saved lives throughout this pandemic.
Secretary Becerra, how do we ensure that there is equitable access
to telehealth services, particularly for individuals who lack a
connection to broadband and rely on audio-only methods to communicate
with their doctors?
Answer. Telehealth is an important tool to improve health equity
and improve access to healthcare. Healthcare should be accessible, no
matter where you live. HHS continues to examine the telehealth
flexibilities developed for the current public health emergency and
determine how we can build on this work to improve health equity and
improve access to healthcare.
There are a number of efforts underway to help underserved
communities and individuals, particularly rural and tribal communities,
utilize telehealth services through access to broadband Internet
connections. HRSA's Office for the Advancement of Telehealth serves as
HHS's focal point on telehealth, which includes the management of the
Telehealth.HHS.gov website and improving collaboration across HHS and
Federal agencies. For example, HRSA's Office for the Advancement of
Telehealth leads a Rural Telehealth Initiative, established through a
memorandum of understanding with HHS, the Federal Communications
Commission, and the
U.S. Department of Agriculture, to increase access to affordable
broadband services, which is the foundation for improving access to
telehealth services. HRSA's Office for the Advancement of Telehealth
also supports grants such as a Telehealth Broadband Pilot Program to
measure access to high speed Internet in rural and underserved
communities as well as programs to support the provision of direct
telehealth services, telementoring, research, licensure portability,
and technical assistance to providers and patients through the
Telehealth Resource Center Programs.
Question. What steps is the Department of Health and Human Services
taking to ensure that Americans who have come to rely on telehealth
services don't lose access when the public health emergency ends?
Answer. Telehealth services are an important tool to improve health
equity and access to healthcare. Throughout the pandemic, telehealth
services have filled an urgent need to maintain access to care while
social distancing was necessary. For example, federally Qualified
Health Centers and Rural Health Clinics were able to be paid by
Medicare as distant site telehealth service providers, which had not
been permitted outside of the COVID-19 public health emergency. After
the pandemic, HHS will continue to support telehealth services. HHS is
currently reviewing the telehealth flexibilities developed for the
current public health emergency to determine which can and should
continue after the public health emergency has ended. HHS plans to
continue to support telehealth after the pandemic through resources
like the Telehealth.HHS.gov website and the Telehealth Resource Centers
so patients and providers have access to telehealth technical
assistance.
Question. The 340B program is essential for providing access to
safe and affordable medications for low-income West Virginians.
Recently HHS determined that six pharmaceutical companies have violated
the program, by restricting access to contract pharmacies. The
undermining of the 340B program by pharmaceutical companies and
pharmacy benefit managers has taken its toll on West Virginia's
hospitals, community health centers and their contract pharmacy
partners.
What are the next steps HHS will be doing to ensure the integrity
of the 340B program?
Answer. On May 17, 2021, HRSA sent letters to six pharmaceutical
manufacturers stating that HRSA has determined that their policies
placing restrictions on 340B Program pricing to covered entities that
dispense medications through pharmacies under contract have resulted in
overcharges and are in direct violation of the 340B statute. In
addition, the letters explain that the 340B Program Ceiling Price and
Civil Monetary Penalties final rule (CMP final rule) states that any
manufacturer participating in the 340B Program that knowingly and
intentionally charges a covered entity more than the ceiling price for
a covered outpatient drug may be subject to a Civil Monetary Penalty
(CMP) not to exceed $5,000 for each instance of overcharging. Any
assessed CMPs would be in addition to repayment for each instance of
overcharging.
In its letters, HRSA informed the pharmaceutical manufacturers that
continued failure to provide the 340B price to covered entities
utilizing contract pharmacies, and the resultant charges to covered
entities of more than the 340B ceiling price, may result in CMPs as
described in the CMP final rule. While there is ongoing litigation on
these matters, HRSA is actively reviewing each manufacturer's response
to its May 17, 2021, letter to determine whether subsequent action,
such as referral to the HHS Office of the Inspector General for the
imposition of CMPs is warranted.
______
Questions Submitted by Senator Roy Blunt
covid-19 boosters
Question. Mr. Secretary, at our last two hearings--one with the CDC
Director and one with the NIH Director--the issue of whether we need
vaccine boosters was raised. Even from our own officials, there seems
to be a divide as to whether they'll be necessary. In early May, BARDA
notified the Subcommittee that they intend to purchase 400 million
vaccine doses for boosters for $7.9 billion. Does that notification
mean that you believe boosters are necessary? Even though neither the
Directors of CDC or NIH have officially said the same? My concern is
that it could be very dangerous if vaccine companies, rather than
public health experts, are stetting the public's expectations around
COVD-19 boosters.
Answer. Throughout the COVID-19 pandemic, BARDA has worked to
develop and ensure that once authorized and/or approved by the FDA
medical countermeasures (including vaccines) would be available to the
American public immediately or with minimal delay. This has meant,
contracting with companies to purchase millions of doses of vaccines
prior to FDA authorization based on the lead time for vaccine
manufacturing to ensure doses are available. Further, many
manufacturers require orders to be placed several months ahead of the
expected delivery date. Placing the order after a need is identified
would result in a lapse/gap in production and ultimate delivery.
Supporting the early manufacturing of countermeasures ensures that
once the FDA issues an EUA, vaccine doses are immediately available. It
has also meant that, if a vaccine we invested in failed, the USG would
have realized the financial risk associated with the aggressive
development strategy underlying Operation Warp Speed which is now
called the Countermeasures Acceleration Group or CAG. BARDA is taking
the same approach to purchasing additional vaccine doses to be
available immediately if/when the FDA authorizes/approves boosters.
covid-19 vaccines donated internationally
Question. Secretary Becerra, on June 3, 2021, the Administration
announced it would donate 80 million vaccines to the international
community by the end of June. Did the Department of Health and Human
Services fund the vaccines that are being donated?
Specifically, which vaccines are being donated? Please provide
estimates based on vaccine producer and number of doses.
Answer. All vaccine doses the Department of Health and Human
Services has purchased to date were ordered for domestic use. However,
international donations have been made available from amounts that have
been in excess of demand once vaccines were available for use.
barda misused funds
Question. In January, the Office of Special Counsel investigated
the misuse of funds appropriated to BARDA. The Special Counsel found
that at least since fiscal year 2010, the Office of Assistant Secretary
for Preparedness and Response misused funds appropriated for BARDA and
failed to accurately report this mismanagement to Congress. In fact,
the practice of using BARDA funding by ASPR for non-BARDA purposes was
so common that it was referred to in the agency as the ``Bank of
BARDA.'' Mr. Secretary, has the Department determined whether these
actions violated the Anti-deficiency Act and what steps has HHS taken
to address this issue?
Answer. HHS/ASPR is committed to ensuring taxpayers dollars are
used in the most judicious manner and in accordance with statutory
obligations. In response to the HHS Inspector General's report, HHS's
Office of Finance is undertaking an internal review of the HHS
Assistant
Secretary for Preparedness and Response (ASPR)'s use of advanced
research and development funding from the Public Health and Social
Services Emergency Fund for fiscal years 2015 through 2019 to identify
any potential Anti-deficiency Act violations. HHS also hired an outside
accounting firm which is auditing ASPR's use of these funds. Both
reviews are estimated to be completed in 2021.
disease x
Question. The COVID-19 pandemic has highlighted the need for the
Federal government to respond rapidly to the next fast-moving, novel
infectious disease. The fiscal year 2021 LHHS bill included language
that encouraged the Department of Health and Human Services to work
with the Department of Defense to implement a program focused on
developing flexible vaccines and antiviral treatments to address
emerging and previously unidentified infectious disease threats,
referred to as Disease X. Mr. Secretary, what progress has the
Department made in implementing such a program and how is the
Department planning to develop countermeasures for previously
unidentified viral threats?
Answer. While no specific Disease X program has been established,
BARDA does have processes and capabilities to prepare to respond to
various disease threats. While BARDA has a mandate to develop medical
countermeasures against emerging infectious disease threats, these
efforts cross over and could support a robust and effective response to
any rapidly emerging infectious disease event, subsequent to funding
availability. One example is BARDA's support of platform technologies
to develop vaccines and therapeutics for Ebola Zaire virus (Merck,
Janssen, Regeneron) and Zika (Moderna). When COVID-19 outbreaks began,
BARDA was able to pivot these efforts to develop medical
countermeasures to aid the response to the emerging threat.
unaccompanied children
Question. Mr. Secretary, while your Department has no role in
setting border policy or enforcing border security, HHS is responsible,
by law, for the safety and well-being of the unaccompanied children
referred to its care. And this fiscal year, HHS is on track to have the
highest number of referrals of unaccompanied children on record, with
almost 69,000 referrals already. Instead of working to open multiple
Influx facilities that provide an equivalent standard of care for
children as the shelters in the permanent network, HHS created a new
concept of Emergency Intake Sites that do not have the same
accountability requirements as Influx facilities and provide children
with only a minimal level of care. Why, months after this crisis began,
have you not opened additional Influx facilities or transitioned some
of these Emergency Intake Sites into Influx facilities?
Answer. ORR's preference is to place unaccompanied children into
state-licensed care provider facilities, including transitional foster
homes while their sponsorship suitability determinations or immigration
cases are adjudicated (in cases when a child has no viable sponsor).
ORR has prioritized increasing its network of state licensed beds by:
(1) safely bringing back online beds that were impacted by COVID-19
restrictions, (2) partnering with current providers to provide
additional bed capacity through recipient-initiated supplements, and
(3) engaging non-governmental organizations and governmental
jurisdictions to identify ways to expand bed capacity. However, during
a time of sustained high referrals, ORR activates and operates Influx
Care Facilities and Emergency Intakes Facilities (EIS) to meet its
statutory obligations to care for unaccompanied children (UC)
transferred from the Department of Homeland Security (DHS) and ensure
that children are not waiting in CBP custody for longer than 72 hours.
Since March 2021, ORR has activated a total of 14 EISs, and to date,
ORR operates only one ICF and three EIS. At a minimum, these EISs
provide lifesaving services, consistent with best practices in
humanitarian and disaster response efforts. In addition, ORR has been
working diligently to ramp up services including wrap-around services,
where possible, to ensure the safety and well-being of the children in
ORR care and custody.
Question. When do you expect to ensure that every unaccompanied
child in the care of HHS receives the required standard of care?
Answer. ORR recognizes that children who enter ORR care may have
experienced significant trauma not only in their home countries but
also during their journey to the United States, and ensures that ORR's
continuum of care remains rooted in trauma-informed care, and
prioritizes the best interest of each child across its network of care
provider facilities, including Carrizo ICF and the EISs.
Question. HHS has transferred or reprogramed almost $3 billion to
cover the costs of the influx of unaccompanied children crossing at the
southern border. Do you expect that the transferred amount will cover
the costs of the UC program for the remainder of the fiscal year?
Answer. Yes. HHS anticipates that the allocated amount will cover
the costs of the UC program through the end of the fiscal year.
Question. Do you anticipate that your request of $3.3 billion for
the program in fiscal year 2022 accurately reflects the amount needed
for the next fiscal year?
Answer. HHS strongly supports the President's budget request.
However, given the ever- evolving situation at the southern border, it
can be challenging to predict medium-to-long term funding needs with
any degree of certainty. HHS continues to gather data and employ
rigorous evaluation methods to inform its budgetary requests and
decisionmaking, and will continue to update the Office of Management
and Budget (OMB) and both the House and Senate Appropriations
Committees on the dynamic situation at the southern border and the
resultant resource requirements. HHS remains committed to working with
Congress to ensure all relevant funding needs are communicated in a
timely manner.
Question. What are the key assumptions behind both of those cost
estimates?
Answer. To arrive at its cost estimates, ORR considers a variety of
factors such as external political events, natural disasters, and other
issues that may impact the number of referrals from DHS.
Additionally, cost estimates for fiscal year 2022 includes
expanding the scope of post-release services and the number of children
who receive them, as well as other critical programmatic reforms such
as improving case management and implementing policies and procedures
intended to reduce the time it takes to unify children with their
sponsors.
organ transplantation
Question. Mr. Secretary, I was pleased to see the Administration
move forward with finalizing the Centers for Medicare and Medicaid
Services' (CMS) rule to improve oversight and accountability of organ
procurement organizations (OPOs) (CMS-3380-F2).
Related, a government contractor, the United Network for Organ
Sharing (UNOS), has great influence over the protocols and processes
for organ procurement and allocation. UNOS has held the government
contract to run the Organ Procurement and Transplantation Network
(OPTN) for roughly 35 years and appears to operate with little to no
oversight by HHS. Over the course of the last few years, UNOS policies
have had the effect of redistributing donated organs from the Midwest
and South to more urban and coastal areas. In addition to the CMS OPO
accountability rule, what more can the Department do to bring
accountability and oversight to the organ procurement process and to
hold the OPTN contractor accountable to actually improve the organ
transplantation system in the U.S.?
Answer. HRSA provides oversight of the OPTN and the OPTN
contractor. HRSA exercises its oversight according to statutory
requirements, regulatory requirements, and through the OPTN contract.
The OPTN Board of Directors develops organ allocation policies with the
advice of the OPTN membership and other interested parties The OPTN
contractor neither develops nor approves OPTN policies. HRSA staff are
ex-officio members of OPTN committees and the OPTN Board of Directors
and attend all OPTN business meetings.
HRSA currently works closely with CMS on CMS' regulation of organ
procurement and transplantation services. Additionally, HRSA and CMS
collaborated to establish a new Affinity Group on Organ Procurement and
Transplantation to improve oversight by the two agencies.
Question. The fiscal year 2021 Appropriations Joint Explanatory
Statement encouraged CMS to consider removing the disincentive for
Medicare Certified Transplant Centers to transfer patients suffering
from complete loss of brain function to organ recovery centers operated
by organ procurement organizations. What is the status of this work at
CMS?
Answer. CMS published a final rule \1\ on December 2, 2020 that
updates the OPO Conditions for Coverage to change the way OPOs are held
accountable for their performance. The final rule improves the current
measures by using objective and reliable data, incentivizes OPOs to
ensure all viable organs are transplanted, and holds OPOs to greater
oversight while driving higher OPO performance. Under new outcome
measures introduced in this final rule, except for pancreas procured
for research (which is required by law to be counted), an OPO will not
receive credit for procuring an organ if the organ is not transplanted,
creating greater incentive for OPOs to place all organs for transplant
that they procure. Following review, the final rule went into effect
March 30, 2021 (except for amendment 3).\2\
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\1\ https://www.Federalregister.gov/documents/2020/12/02/2020-
26329/medicare-and-medicaid-programs-organ-procurement-organizations-
conditions-for-coverage-revisions-to.
\2\ The January 20, 2021 memorandum from the Assistant to the
President and Chief of Staff, entitled ``Regulatory Freeze Pending
Review,'' instructed Federal agencies to delay the effective date of
rules published in the Federal Register, but which have not yet taken
effect, for a period of 60 days. The effective date of the final rule,
except for amendment number 3, which would have been February 1, 2021,
became March 30, 2021. CMS also included a 30-day public comment period
on the rule to allow interested parties to provide comments about
issues of fact, law and policy raised by the rule. The 60-day delay in
effective date was necessary to give Department officials the
opportunity for further review of the issues of fact, law, and policy
raised by this rule.
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mental health
Question. The pandemic has exacerbated the children's mental health
crisis across the country and we are seeing alarming increases in
children presenting in emergency rooms in severe crisis. Could you
comment on how your budget addresses this crisis and ensures that
children can get access to mental and behavioral health services
earlier, closer to home, and in their communities?
What are your thoughts on further efforts we should consider to
direct funding to address this crisis, such as Children's Hospital
Graduate Medical Education which helps train frontline professionals
focused on treating children's mental and behavioral health?
Answer. HHS is committed to improving access to mental and
behavioral healthcare services for children and families. The fiscal
year 2022 President's Budget requests includes an additional $756
million for SAMHSA to increase access to children's behavioral health
services, which includes $473 million for mental health, $281 million
for substance use treatment, and $2 million for substance use
prevention related services and activities.
Within HRSA, the Budget provides $10 million for pediatric mental
healthcare access to increase access to behavioral health. This
investment promotes behavioral health integration in pediatric primary
care by supporting the development of new, or the improvement of
existing, statewide or regional pediatric mental healthcare telehealth
access programs.
The Children's Hospitals Graduate Medical Education (CHGME) Program
is a formula based payment program that helps eligible hospitals
maintain Graduate Medical Education (GME) programs to support graduate
training for physicians to provide quality care to children. As such,
the program supports the training of pediatric psychiatrists and other
pediatric physician behavioral subspecialists. In Academic Year 2019-
2020, 199 Child and Adolescent Psychiatry fellows received training
through the CHGME Program. In addition, CHGME-funded hospitals served
as sponsoring institutions for 42 residency programs and 252 fellowship
programs, and also served as major participating rotation sites for 628
additional residency and fellowship programs. The CHGME Program also
supported the training of 5,433 Pediatric residents that included
General Pediatrics residents, as well as residents from seven types of
combined pediatrics programs (e.g., Internal Medicine/Pediatrics). In
total, 3,055 Pediatric Medical Subspecialists, including 199 Child and
Adolescent Psychiatry fellows, received training.
hyde amendment
Question. Mr. Secretary, for more than forty years, Democrat and
Republican-led Administrations, as well as Democrat and Republican-led
Congresses have supported the principle that taxpayer dollars should
not fund elective abortions. As members of Congress, President Biden,
Vice President Harris, and you, Mr. Secretary, all voted in favor of
funding bills year after year that included this prohibition. It
remains unclear why this radical change in public policy is suddenly an
imperative for the Biden Administration to fund elective abortions with
taxpayer dollars. Further, your request does not detail the cost this
change will have on the U.Ss taxpayer. Can you please provide an
estimate of how many abortions would receive Federal funding, and what
amount of Federal expenditures would be incurred to pay for abortions,
relative to current law for this fiscal year and the next ten?
Answer. The Hyde Amendment disproportionately impacts the growing
number of low- income, women of color who are enrolled in Medicaid, and
is a barrier to expanding access to healthcare. That is why the
President's first budget calls for Congress to remove the restriction
from government spending bills.
The Department of Health & Human Services implements the laws that
Congress passes. Implementation of any changes in coverage related to
the President's Budget would depend on the final language Congress
passes. After passage of any legislation, agency staff and counsel
review the language to determine the agency's authority and options for
implementation action, such as initiating notice and comment rulemaking
or issuing guidance documents.
Question. HHS issued a proposed rule in April that would allow
Title X grantees to promote abortion as a form of family planning. The
preamble of the proposed rule cites ``that Planned Parenthood conducted
a major fundraising campaign with the 2019 Title X regulatory changes
as its key motivating message. If funds are more efficiently gathered
and distributed via a program such as Title X than through such private
campaigns, the efficiency would represent a cost savings attributable
to the proposed rule.'' It is widely known that Planned Parenthood
walked away from the Title X program in 2019, so I am troubled by the
fact that HHS' proposal implies that Planned Parenthood is somehow
entitled to taxpayer funding. This notion and the rush to finalize the
proposed rule also raises questions about your agency's ability to be
impartial in awarding of future Title X grants. How is this proposed
rule not a kickback to Planned Parenthood?
Answer. On January 28, 2021, President Biden issued a ``Memorandum
on Protecting Women's Health at Home and Abroad'' directing the
Department to review the 2019 Title X Final Rule and ``consider, as
soon as practicable, whether to suspend, revise, or rescind, or publish
for notice and comment proposed rules suspending, revising, or
rescinding, those regulations, consistent with applicable law,
including the Administrative Procedure Act.'' The memorandum stated
that undue restrictions on the use of Federal funds have made it harder
for women to access medical information.
After conducting an extensive review and consideration of the 2019
Title X Final Rule (84 Fed. Reg. 7714) pursuant to the Presidential
memorandum, the Department published a Notice of Proposed Rulemaking
(NPRM) entitled ``Ensuring access to equitable, affordable, client-
centered, quality family planning services'' in the Federal Register
that was open for public comment from April 15, 2021 to May 17, 2021.
As outlined by the Title X statute and reinforced in its
regulations, ``None of the funds appropriated under this title shall be
used in programs where abortion is a method of family planning.''
Consistent with the program's statute and regulations, any public or
private nonprofit organizations, including faith-based organizations,
state, county, local, and tribal governments, school districts, and
public and state higher education institutions are eligible to apply
for Title X grant funds. Title X's regulations, in the NPRM, also
clearly define the criteria the Department uses to decide which family
planning services projects to fund and in what amount.
psychological clinical science accreditation system
Question. The fiscal year 2021 Appropriations Joint Explanatory
Statement encouraged HHS to ``review the accreditation and eligibility
requirements for the Public Health Service Corps and behavioral health
workforce programs to allow access to the best qualified applicants,
including those who graduate from Psychological Clinical Science
Accreditation System (PCSAS) programs.'' Currently, there are more than
40 PCSAS University accredited doctoral programs in psychological
clinical science, including Washington University in St. Louis, but the
Department's guidance and regulations were adopted prior to the
establishment of PCSAS and do not permit the graduates of PCSAS
programs to be eligible to compete for these funding opportunities.
What is the status of this review and updates at the Department and
within the Health Resources and Services Administration, as it relates
to the behavioral health workforce programs?
If this process has not yet started, please provide an explanation,
an estimated start date, and any additional information that may be
necessary to proceed.
Answer. HRSA is currently exploring options to include PCSAS
doctoral programs as eligible entities in the upcoming fiscal year 2022
Graduate Psychology Education competition. HRSA will continue to
explore options to include such programs in other future competitions,
including, but not limited to, the Behavioral Health Workforce
Education and Training program, and the Geriatric Academic Career
Awards. HRSA currently anticipates posting the Notice of Funding
Opportunity for the Graduate Psychology Education program in November
2021.
provider relief fund (prf)
Question. Mr. Secretary, Congress provided $178 billion over the
course of the last year for the Provider Relief Fund, and the American
Rescue Plan included an additional $8.5 billion for rural providers.
How is HHS planning to distribute the approximately $50 billion
remaining, and when can we expect to see the distribution?
Answer. HHS is committed to distributing the remaining provider
relief payments as quickly, transparently, and equitably as possible
while utilizing effective safeguards to protect taxpayer dollars.
HHS is planning for future Provider Relief Fund (PRF) allocations,
including the $8.5 billion from American Rescue Plan Act and Phase 4 of
the General Distribution.
HHS is actively considering feedback from stakeholders, as well as
operational lessons learned from prior PRF payments, as part of the
planning process. The feedback from Members of Congress and other
stakeholders informs HHS' ability to administer the PRF in a manner
that bolsters the healthcare system and helps providers experiencing
COVID-related financial hardships during this crisis. HHS will publish
additional information on future distributions on the Health Resources
and Services Administration's PRF webpage, at www.hrsa.gov/provider-
relief, as soon as it becomes available.
Question. How are you planning to account for the ongoing needs of
rural hospitals and rural healthcare providers in the distribution of
the $8.5 billion?
Answer. HHS is working to finalize the $8.5 billion in American
Rescue Plan Act of 2021 funding for rural Medicare and Medicaid
providers and suppliers. HHS will publish additional information on
future distributions on the Health Resources and Services
Administration's PRF webpage, at www.hrsa.gov/provider-relief, as soon
as it becomes available.
opioids
Question. There is no question that the pandemic has been
challenging for many people and the data shows an unprecedented rise in
opioid overdose deaths in 2020. What can you say about the latest
trends in opioid overdoses and what we need to do to build on the
investments of the last 6 years to combat the opioid epidemic?
Answer. The overdose crisis has certainly worsened in the face of
the COVID-19 public health emergency. Estimates from the CDC find that
more than 90,000 drug overdose deaths have occurred in the 12 months
ending in September 2020. That represents a year-over-year increase of
close to 29 percent. For the last few years, this increase in lives
lost is principally driven by synthetic opioids like fentanyl, but
increasingly, we are seeing stimulants, including methamphetamine and
cocaine also involved. HHS is investing $11.2 billion in programs
responding to the overdose crisis, an increase of $3.9 billion over
fiscal year 2021 Enacted, with the goal of ending the crisis of opioids
and other substance use by increasing funding for States and Tribes for
medication-assisted treatment, and by expanding the behavioral health
provider workforce. Of the $11.2 billion, $6.6 billion is from SAMHSA's
prevention and treatment activities that address the substance use and
opioid crisis, an increase of $2.6 billion over Fiscal year 2021
enacted. HHS is committed to investments in the Substance Abuse
Prevention and Treatment Block grant to expand implementation of
evidence-based prevention, treatment and recovery support services for
individuals, families, and communities across the nation. The budget
includes a new 10 percent set-aside to direct funds to states for
recovery support services, which can be provided prior to, during,
after, and in lieu of treatment. This funding will allow SAMHSA to
serve 2.1 million people in fiscal year 2022 and to significant
strengthen the Nation's recovery support services infrastructure. The
fiscal year 2022 President's Budget also makes significant investments
in First Responder Training programs to train first responders to
respond to and prevent opioid overdose deaths, as well as expanding
treatment for SUD for pregnant and post-partum women.
HHS is committed to continued support for efforts to increase
access to SUD and broader behavioral healthcare services through the
Rural Communities Opioid Response Program (RCORP). The budget includes
a total of $165 million to support prevention, treatment, and recovery
services for opioids and other SUDs in the highest-risk rural
communities. Through RCORP, more than 23,000 individuals received
medication-assisted treatment; and the number of DATA-waivered
providers serving rural communities was increased. In fiscal year 2019
and 2020, the National Health Service Corps Rural Community Loan
Repayment Program (NHSC RC LRP) also served to further increase access
to behavioral healthcare workforce services in rural communities with
651 providers working in rural communities, and 118 of those working
specifically at RCORP service sites.
Other considerations to address the overdose epidemic include:
Treatment Capacity: The SAMHSA-HRSA Workforce projections report
indicates a shortage of over 10,000 full time equivalents for child
psychiatrists and master's level mental and SUD counselors by the year
2025. The report also highlights the need for peer specialists in a
wide variety of integrated and specialty care settings. Peers, as
members of integrated healthcare teams, support all team members in
working at the top of their scope of practice, improving efficiency and
maximizing skill utilization.
Decreasing Barriers: Research reveals geographic and
sociodemographic barriers to receiving treatment.\3\ Indeed, many
treatment facilities are found in urban and suburban areas, and there
is disparity in access to buprenorphine providers and Opioid Treatment
Programs (OTPs).\4\ Recent policy changes, such as The Practice
Guidelines for the Administration of Buprenorphine for Treating Opioid
Use Disorder, remove perceived barriers to obtaining a DATA-2000 Waiver
and expand access to this treatment.. New flexibilities enable more
OTPs to establish mobile medication units (e.g., vans), which can
improve geographic access and expand the provision of opioid use
disorder treatment to disparate populations. Grants such as the State
Opioid Response (SOR), Medicated Assisted Treatment for Prescription
Drug and Opioid Addiction (MAT-PDOA), Targeted Capacity Expansion-
Special Projects (TCE-SP), and Screening, Brief Intervention and
Referral to Treatment (SBIRT) will be used to address this need. The
fiscal year 2022 President's Budget Request proposes increases for each
of these programs.
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\3\ Sharma RN, Casas RN, Crawford NM, Mills LN. Geographic
distribution of California mental health professionals in relation to
sociodemographic characteristics. Cultur Divers Ethnic Minor Psychol.
2017 Oct;23(4):595-600.
\4\ Goedel WC, Shapiro A, Cerda M, Tsai JW, Hadland SE, Marshall
BDL. Association of Racial/Ethnic Segregation With Treatment Capacity
for Opioid Use Disorder in Counties in the United States. JAMA Netw
Open. 2020;3(4):e203711. Published 2020 Apr 1. doi:10.1001/
jamanetworkopen.2020.3711.
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Wrap Around Services Addressing Social Determinants of Health:
These services not only improve the treatment experience, but also
provide support to clients during their recovery. For example, research
demonstrates that women's SUD treatment outcomes are improved when
women-specific needs are addressed through wraparound services, such as
the provision of childcare, employment assistance, or mental health
counseling.\5\ Additionally, the receipt of basic needs, child care,
educational, family, and medical services is associated with
improvements in several outcomes.\6\ These services represent an
important opportunity to support clients and to ameliorate many of
those social determinants of health that precipitate substance misuse.
That is why the fiscal year 2022 President's Budget Request proposes
increase for programs such as the Pregnant & Postpartum Women,
Treatment, Recovery, and Workforce Support, Adult and Family Treatment
Drug Courts.
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\5\ Oser C, Knudsen H, Staton-Tindall M, Leukefeld C. The adoption
of wraparound services among substance abuse treatment organizations
serving criminal offenders: The role of a women-specific program. Drug
Alcohol Depend. 2009;103 Suppl 1(Suppl 1):S82-S90. doi:10.1016/
j.drugalcdep.2008.12.008.
\6\ Pringle, J, et al. The Role of Wrap Around Services in
Retention and Outcome in Substance Abuse Treatment: Findings From the
Wrap Around Services Impact Study. Addict Disord Their Treatment
2002;1:109--118.
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Telehealth: The recent pandemic has demonstrated the utility of
telehealth in reaching disparate populations. Telehealth is a mode of
service delivery that has been used in clinical settings for over 60
years and empirically studied in the mental health space for over 20
years.\7\ Telehealth is not an intervention itself, but rather a mode
of delivering services. This mode of service delivery increases access
to screening, assessment, treatment, recovery supports, crisis support,
and medication management \8\ across diverse behavioral health and
primary care settings. Practitioners can offer telehealth through
synchronous and asynchronous methods. The increase requested under
SAMHSA's SOR grants can be used to address this need.
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\7\ Bashshur, R. L., Shannon, G. W., Bashshur, N., & Yellowlees, P.
M. (2016). The empirical evidence for telemedicine interventions in
mental disorders. Telemedicine and e-Health, 22(2), 87-113.
\8\ Substance Abuse and Mental Health Services Administration.
(2015). Using technology-based therapeutic tools in behavioral health
services. Treatment Improvement Protocol (TIP) Series 60.
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Evidence Based Practice: There is a need for combining leadership
development with organizational strategies to support a climate
conducive to evidence based practice implementation.\9\ This represents
an opportunity to promulgate the evidence and best practices through
SAMHSA publications, reports, and announcements. Beyond this, SAMHSA
will work with grantees to consider implementation science strategies
that support program sustainability and fidelity to the evidence base.
The Evidence-Based Practice Center and Technical Assistance Grants will
be used to address this need. Additionally, the Prevention Technology
Transfer Center Network and the Addiction Technology Transfer Network
will continue to help states develop capacity through training,
consultation, and technical assistance and SAMHSA's new Peer Recovery
Center of Excellence, authorized under Section 7152 of the SUPPORT Act
for Patients and Communities, will continue to provide training and
technical assistance to support integration of peer support workers
into non-traditional settings, build and strengthen recovery community
organizations, a key component of recovery support services
infrastructure. It will also enhance the professionalization of peers
through workforce development, providing evidence-based and practice-
based toolkits and resources to diverse stakeholders.
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\9\ Aarons GA, Ehrhart MG, Moullin JC, Torres EM, Green AE. Testing
the leadership and organizational change for implementation (LOCI)
intervention in substance abuse treatment: a cluster randomized trial
study protocol. Implement Sci. 2017 Mar 3;12(1):29.
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Harm Reduction Activities: The promotion and distribution of
naloxone and fentanyl test strips, similar to the existing syringe
services programs, represents an opportunity to not only promote life-
saving interventions, but to also provide education on drug potency and
mortality.\10\ This might be achieved in partnership with public safety
agencies, providers, community organizations and the public.
Additionally, syringe services programs reduce transmission of HIV and
viral hepatitis within the community. A comprehensive and coordinated
approach must incorporate innovative and established prevention and
response strategies, including those focused on polysubstance use.
Among the programs that can support these efforts are the Treatment
Systems for Homeless and Minority AIDS program, both of which request
an increase in funding.
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\10\ Han JK, Hill LG, Koenig ME, Das N. Naloxone Counseling for
Harm Reduction and Patient Engagement. Fam Med. 2017 Oct;49(9):730-733.
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Education: Medical school graduates play a pivotal role in
educating their patients and colleagues; screening, diagnosing, and
treating patients; and modeling positive attitudes to reduce the stigma
attached to SUDs. Research demonstrates that SUD educational
interventions, using various approaches and durations, produce a
positive impact on medical students' knowledge, skills, and
attitudes.\11\ Studies also reveal that simply increasing exposure to
patients with addiction does not provide the formative knowledge
required to identify, treat or even prevent SUDs without the presence
of a concurrent, comprehensive didactic curriculum.\12\ Even as the
overdose crisis deepens, there remains wide heterogeneity in SUD
curricula across medical schools.\13\ This adversely impacts patient
care--a lack of preparedness has been identified as a barrier in the
provision of buprenorphine to patients with opioid use disorder by
early career family physicians.\14\ Moreover, a lack of appropriate
education has also been shown to foster negative attitudes towards the
treatment of SUD with buprenorphine.\15\ Such negative attitudes
adversely impact patient-physician dialogues and contribute to the
under treatment of SUDs by primary care and specialty providers.\16\
Comprehensive and uniform medical school teaching on SUDs, addiction,
and treatment modalities has the potential to overcome these deficits
and to positively impact all graduates and their patients. It also
represents an important area of engagement with academic institutions.
The Provider's Clinical Support System--Universities (PCSS-
Universities) grant will be used to address this need and would be
further supported by the increase proposed in the fiscal year 2022
President's Budget Request.
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\11\ Muzyk A, Smothers ZPW, Akrobetu D, Ruiz Veve J, MacEachern M,
Tetrault JM, Gruppen L. Substance Use Disorder Education in Medical
Schools: A Scoping Review. Acad Med. 2019 Nov;94(11):1825-1834. doi:
10.1097/ACM.0000000000002883. PMID: 31663960.
\12\ Tetrault, J. Improving Health Professions Education to Treat
Addiction: The Time Has Come. The Josiah Macy Jr Foundation, News and
Commentary. May 2018.
\13\ Blanco, C., Wiley, T.R.A., Lloyd, J.J. et al. America's opioid
crisis: the need for an integrated public health approach. Transl
Psychiatry 10, 167 (2020). https://doi.org/10.1038/s41398-020-0847-1.
\14\ DeFlavio JR, Rolin SA, Nordstrom BR, Kazal LA Jr. Analysis of
barriers to adoption of buprenorphine maintenance therapy by family
physicians. Rural Remote Health. 2015;15:3019.
\15\ Tong ST, Hochheimer CJ, Peterson LE, Krist AH. Buprenorphine
Provision by Early Career Family Physicians. Ann Fam Med.
2018;16(5):443-446. doi:10.1370/afm.2261
\16\ Kennedy-Hendricks A, Busch SH, McGinty EE, et al. Primary care
physicians' perspectives on the prescription opioid epidemic. Drug
Alcohol Depend. 2016;165:61-70.
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Reducing Stigma: Stigma can reduce willingness of policymakers to
allocate resources, reduce willingness of providers in non-specialty
settings to screen for and address substance misuse , and may limit
willingness of individuals with SUDs to seek treatment.\17\ Negative
attitudes toward patients with substance use disorder are common among
health professionals, who generally lack adequate education, training
and support structures to effectively serve patients with SUD. Health
professionals' negative attitudes reduced patients' feelings of
empowerment and diminished treatment outcomes. These attitudes resulted
in less provider engagement, a more task-oriented approach to care
delivery, and diminished empathy.\18\ All of these factors may help
explain why so few individuals with SUDs receive treatment. Public
education that reduces stigma and provides information about treatment
is needed. This represents an opportunity to engage across multiple
disciplines and modalities. Among others, PCSS-U and SOR grants seek to
overcome stigma. The fiscal year 2022 President's Budget requested
increases for both programs.
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\17\ Yang LH, Wong LY, Grivel MM, Hasin DS. Stigma and substance
use disorders: an international phenomenon. Curr Opin Psychiatry.
2017;30(5):378-388.
\18\ van Boekel LC, Brouwers EPM, van Weeghel J, Garretsen HFL.
Stigma among health professionals towards patients with substance use
disorders and its consequences for healthcare delivery: Systematic
review. Drug and Alcohol Dependence. 2013;131(1):23-35.
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Partnering With Public Safety Officials And Community
Organizations: Working with law enforcement, community groups,
patients, and treatment teams to address the growing overdose epidemic
has the potential to channel new ideas, data sources, and efforts
towards reducing mortality and use of illicit substances. Such
engagement promotes cross collaboration and encourages the creation of
innovative and community focused interventions, such as pre- and post-
arrest deflection to treatment. Increases proposed to SAMHSA grants
such as the First Responder Training/Rural Emergency Medical Services
can help address this need.
Question. This Subcommittee has worked in a bipartisan fashion to
provide $4 billion in fiscal year 2021 to address the opioid epidemic,
including $1.5 billion for State Opioid Response grants. This is a
flexible grant provided directly to states to use funds as they see
fit. Unfortunately, we continue to hear that states are not spending
those funds in a timely manner. Does HHS know why this is the case?
Answer. The State Opioid Response (SOR) grants give states
flexibility in providing a range of prevention, treatment, and recovery
support services for opioid and stimulant use disorders. The grants
also support infrastructure development to enhance/expand systems of
care. One of the most common reasons grantees attribute spending
challenges to is state procurement processes. Procurement challenges
include state legislative timelines that do not align with Federal
appropriation cycles; reluctance from contract bidders because of the
short duration of the grant (i.e., 2 years); and delays that result
from contract negotiations. Grantees have also cited challenges related
workforce shortages. Additionally, the COVID-19 pandemic has also
impacted states' ability to spend funds.
Question. How does this trend align with the 50 percent budget
increase for SOR?
Answer. The fiscal year 2022 President's Budget increased the State
Opioid Response grant program to allow grantees to enhance and expand
evidence-based opioid and stimulant use disorder prevention, treatment
and recovery support activities currently underway. Additionally,
grantees will have the ability to increase their focus and efforts on
continued areas of need such as workforce development, harm reduction
and public education and training. This will also increase access to
opioid and stimulant use disorder treatment services in states,
territories, and tribes. Within this total, SAMHSA will direct $75
million to the Tribal Opioid Response grant program to specifically
address the opioid substance use needs in tribal communities. This
critical investment will drive funding to States and Tribes to increase
community-level response to the opioid crisis, expand access to
evidence-based treatment and recovery services, and provide targeted
investment to crisis services and recovery support services. HHS is
committed to working to ensure that the SOR program supports states in
addressing and investing in evidence-based treatment and recovery
services for the ongoing opioid and substance use epidemic. SAMHSA is
committed to providing technical assistance to ensure states understand
how they can utilize these funds, as well as oversight to ensure funds
are spent appropriately in a timely manner.
Question. What can be done to increase the spending rates by
states?
Answer. Currently, SAMHSA monitors grantees' program implementation
activities and provides feedback to states when benchmarks are not
being met. SAMHSA also has a wealth of general and targeted technical
assistance resources that SOR grantees may access. For example, the
Addiction Technology Transfer Center (ATTC) Network is a
multidisciplinary resource for professionals in the addiction treatment
and recovery services field. The ATTC Network's mission and vision are
to: accelerate the adoption and implementation of evidence-based and
promising addiction treatment and recovery-oriented practices and
services; heighten the awareness, knowledge, and skills of the
workforce that addresses the needs of people with substance use or
other behavioral health disorders; and foster regional and national
alliances among culturally diverse practitioners, researchers, policy
makers, funders, and the recovery community. SAMHSA also funds the
Opioid Response Network (ORN) which was designed to provide training
and other resources in efforts to address the opioid crisis. The ORN
has local consultants in all 50 states and nine territories to respond
to local needs by providing free educational resources and training to
states, communities and individuals in the prevention, treatment and
recovery of opioid use disorders and stimulant use. SAMHSA has also
extended flexibilities to grantees considering the COVID-19 pandemic
including granting no-cost extensions to give grantees up to an
additional 12 months to use any unexpended funds from the official
grant period.
Question. To respond to the changing nature of the opioid epidemic,
the fiscal year 2020 LHHS bill expanded the State Opioid Response grant
authority to allow states to use funds on stimulants, like cocaine and
methamphetamine. Mr. Secretary, how is the rising use of stimulants
impacting the ability for state and local communities to provide
effective treatment for opioid use disorders?
Answer. The Department has no evidence to suggest that the rise in
use of stimulants is impacting states' ability to provide effective
treatment for opioid use disorders.
It is important to consider stimulant misuse in the context of
polysubstance misuse--increasingly, substances are not used in
isolation. Individuals with polysubstance misuse involving alcohol,
marijuana, opioids, and/or stimulants receive care in a variety of
settings, and often require withdrawal management, psychological and
FDA-approved pharmacological treatment, and monitoring as part of their
care plan.
SAMHSA recently created an Evidence-Based Practice Guide to address
polysubstance misuse. Through a literature review and consensus from
technical experts, SAMHSA identified three effective practices used to
treat polysubstance misuse in adults. These are (1) FDA-approved
pharmacotherapy with counseling; (2) Contingency management (CM) with
FDA-approved pharmacotherapy and counseling, and (3) Twelve-step
facilitation (TSF) therapy with FDA-approved pharmacotherapy. These
treatments should be delivered in a patient-centered and integrated
manner in order to achieve the best outcomes. Many facilities offer
such treatments, and they demonstrate a high level of success.
There currently are no Food and Drug Administration-approved
medications specific for stimulant use disorders, making it important
that behavioral health and healthcare service providers understand and
offer (or offer referrals for) CM or other psychosocial treatments.
Despite an increase in research into psychosocial treatments for people
with stimulant use disorders, currently the only treatment with
significant evidence of effectiveness is CM. Other psychosocial
treatments that have some support (especially if used in combination
with CM) are cognitive--behavioral therapy/relapse prevention,
community reinforcement, and motivational interviewing. These
interventions demonstrate efficacy in treating stimulant use disorder
across age ranges. SAMHSA's State Opioid Response grants allow the use
of Federal funds to provide CM. In treating stimulant use disorder,
clinicians also are recommended to promote harm reduction (especially
because of the high level of contamination of the drug supply with
fentanyl and analogs) through educating about needle exchange programs,
offering naloxone, and encouraging the use of fentanyl test strips, as
these strategies can help save lives.
``ending hiv'' initiative
Question. I was pleased to see the fiscal year 2022 budget increase
of $267 million for the Ending the HIV Epidemic initiative, started by
this Subcommittee in fiscal year 2020. The Trump Administration,
however, was notably more aggressive in their funding requests to
address the HIV epidemic, requesting $716 million in the second year of
the initiative. After the challenging year of the pandemic, where do we
stand as a nation in combatting new HIV infections?
Answer. Although it is too early to assess quantitatively the full
impact of COVID-19 on HIV research, based on listening sessions
conducted by the NIH OAR across the United States, the COVID-19
pandemic has placed a tremendous strain on sustaining research in
general. Basic and translational research unrelated to COVID-19 in
academic settings was suspended for months, severely delaying progress
for trainees and principal investigators. Healthcare workers and
clinical researchers were diverted to the care of COVID-19 patients,
while clinical research resources had to be redirected to COVID-19.\19\
Recruitment and staffing for HIV and other clinical trials was halted
due to distancing, travel restrictions and ``lockdown'' measures.
Broadly, public health measures required to control the spread of
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have led
to societal restrictions that have negatively impacted the economy and
limited access to routine non-emergency healthcare. Specifically, the
COVID-19 pandemic has had a negative effect on HIV testing, linkage to
care, and access to treatment and HIV research laboratories and
investigation sites.
---------------------------------------------------------------------------
\19\ nature.com/articles/s41581-020-00336-9.
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Preliminary reports suggest that COVID-19 is likely to affect key
HIV study outcomes. For example, adverse events may be caused by SARS-
CoV-2 infection or by deferral of care for other health issues due to
fear of contracting SARS-CoV-2 infection. Research study participants
likely changed their lifestyles to minimize contact with others, which
may affect research outcomes. SARS-CoV-2 infection could worsen HIV
comorbidities, such as glycemic control in persons with diabetes, blood
pressure control in those with hypertension, or accelerate progression
of chronic kidney disease.\20\
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\20\ academic.oup.com/jid/advance-article/doi/10.1093/infdis/
jiab114/6167835.
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The impact of COVID-19 on HIV research has been bidirectional.
Contributions by the HIV researchers and community to COVID-related
efforts are significant: from the successful mRNA vaccine platform, to
clinical trials networks for testing candidate vaccines, to rapid
testing and molecular epidemiology for tracking--the HIV research
footprint is widely recognized in the response to COVID-19. In
addition, there have been some positive aspects related to the COVID-19
response, such as the accelerated innovations that have advanced the
way we conduct clinical research overall. These include new approaches
to conduct remote visits by telehealth, use home-based testing or
monitoring technologies. The NIH OAR HIV and COVID-19 Taskforce is
meeting to discuss further impacts of the COVID-19 pandemic on HIV
research progress and investigator retention within the NIH extramural
community.
Question. What factors were considered for the fiscal year 2022
funding request? Please provide an updated cost estimate of resources
needed over the next 5-years, by fiscal year and Operating Division for
the Ending the HIV Epidemic initiative.
Answer. The Centers for Disease Control and Prevention (CDC)
developed a methodology to estimate the number of people who need to be
tested, diagnosed, and provided HIV medical care and treatment or PrEP.
The CDC's methodology then informed the initial EHE budget for HRSA,
which was developed to meet the EHE goal of enrolling newly diagnosed
and people with HIV no longer in care into EHE-funded medical,
treatment, and support services.
CDC provided data to HRSA on the number of diagnosed people with
HIV in each Eligible Metropolitan Area, Transitional Grant Area, or
State (not just the county of interest). HRSA then used CDC estimates
for the percent of people with HIV who are undiagnosed in each state to
calculate estimated undiagnosed. Using this data, overall cost
estimates were then developed using the average RWHAP costs per person
served.
The HRSA cost estimates for the EHE initiative are outlined in the
table below. The Health Center fiscal year 2022 budget request for the
EHE Initiative was developed in the context of increasing participation
in the Phase I targeted areas. The estimated number of clients served
(reflected below) through the EHE were adjusted from the initial
estimates for the EHE initiative to align with appropriated funds.
Projections for fiscal year 2023 and beyond are under development.
[Dollars in millions]
------------------------------------------------------------------------
Fiscal Year
-------------------------------
2021 Enacted 2022 Budget
------------------------------------------------------------------------
Health Centers.......................... $102.25 $152.25
HAB EHE................................. $105.00 $190.00
-------------------------------
Total............................... $207.25 $342.25
-------------------------------
Estimated Clients:
Budget Health Centers (PrEP)............ 285,000 425,000
HAB EHE................................. 27,000 50,000
------------------------------------------------------------------------
Question. The jurisdictions involved in the Ending the HIV Epidemic
program have invested significant resources. Do you anticipate any
changes to the geographic distribution of the funding?
How does the initiative account for new HIV outbreaks, such as
what's happening in West Virginia, which wasn't one of the seven
targeted states?
Answer. No, HRSA does not anticipate any changes to the geographic
distribution of funding in fiscal year 2022.
HRSA health centers continue to make HIV prevention technical
assistance and training available nationwide, including those centers
with increasing HIV prevalence in their communities. In total for
fiscal year 2020, health centers across the U.S. reported providing
approximately 2.5 million HIV tests and PrEP related services to
389,000 health center patients.
HRSA also responds to HIV outbreaks through the RWHAP's established
care, treatment and support systems in partnership with the CDC. Since
2015, HRSA's RWHAP has worked closely with CDC to address HIV outbreaks
that have resulted from injection drug use, such as what is happening
in West Virginia. This collaboration has been crucial in helping states
and local communities identify those at risk for HIV due to injection
drug use, getting at-risk individuals tested for HIV and hepatitis C,
and getting people linked to and engaged in services for HIV and
hepatitis care or for pre-exposure prophylaxis, substance use disorder
treatment and other needed services.
supplemental and reconciliation funding
Question. In response to the COVID-19 pandemic, states have
received billions of dollars in aid, with the intent of giving them
maximum flexibility to respond to their unique needs and challenges. It
is my understanding there is a sizable portion of unobligated funds
remaining from the bipartisan emergency supplemental bills. And now
there is even more funding provided for similar activities as part of
the partisan reconciliation bill. While it is important to know how
fast HHS is getting this funding into the hands of the frontline
responders on the state level, it is just as important to know if the
states are actually spending the money. What are the spend rates that
HHS is seeing at the state level?
Answer. HHS has awarded over $146 billion to states across six
supplemental appropriations. In many cases, funds were directed to
states by Congress in the COVID supplemental appropriations. As of
early November, award recipients have drawn down $29.5 billion, or
twenty percent, of the total funding awarded. When examining the first
four supplementals, state recipients have drawn down at least 50
percent or significantly higher percentages for resources appropriated
at the earliest stages of the pandemic. Evaluating how the funds are
being used cannot be achieved by examining draw down data alone since
it is not a good indicator of how much jurisdictions have spent. States
and jurisdictions are able to bill again their awards through the end
of the established period of performance for that specific award.
Funding recipients will typically draw down funds as expenses are
incurred or after activities are executed and invoices are reconciled
to confirm reimbursement totals. Drawdowns may occur monthly,
quarterly, or at another frequency depending on the awardee. As a
result there can be a significant time lag in the draw down data since
actual state and jurisdiction expenditures are usually greater than the
amount reflected in our draw down data. HHS grants policies and
regulations require monitoring and award recipient reporting and HHS
agencies closely monitor award recipient performance, activities, and
progress through regular engagement.
Question. What accountability do the states have to tell the
Department how they used the funds?
Answer. With respect to Centers for Disease Control and Prevention
(CDC) grant awards, HHS awarding agencies adhere to HHS Grant Policies
and Regulations, which detail required monitoring and reporting for
award recipients. These may differ in frequency by type of award or
program.
CDC for example continuously and closely monitors recipient/
jurisdiction performance, activities, and progress through regular
engagement. Monitoring activities include routine and ongoing
communication between CDC and recipients, site visits, and recipient
reporting (including work plans, performance, and financial reporting).
Monitoring includes tracking recipient progress in achieving the
desired outcomes, ensuring the adequacy of recipient systems that
underlie and generate data reports, and creating an environment that
fosters integrity in program performance and results.
Monitoring may also include the following activities deemed
necessary to monitor an award.
--Ensuring that work plans are feasible based on the budget and
consistent with the intent of the award.
--Ensuring that recipients are performing at a sufficient level to
achieve outcomes within stated timeframes.
--Working with recipients on adjusting the work plan based on
achievement of outcomes, evaluation results and changing
budgets.
--Monitoring performance measures (both programmatic and financial)
to assure satisfactory performance levels.
CDC complies with HHS requirements to implement internal tracking
methods for issued Federal awards. Award recipients report expenditures
into HHS' Payment Management System (PMS) quarterly and submit a Final
Financial Report 90 days after the end of the budget period. All awards
have assigned budget activity codes that are used to track and monitor
funding
Question. Given the unprecedented amount of funding going out from
HHS as a result of the partisan reconciliation bill, can you explain
HHS' decisionmaking process and planning mechanisms for deploying such
large sums of money in such a short period of time?
How does HHS plan for states and the public health infrastructure
to sustain these advancements when the funding runs out?
Answer. The American Recuse Plan provided over $160 billion for
activities across HHS agencies. The legislation identified specific
purposes for the resources appropriated to HHS agencies and many were
intended to support states public health. In many cases, HHS was able
to leverage existing program mechanisms to efficiently and quickly
execute funding. For example, the American Rescue Plan appropriated
substantial resources for existing block grants within ACF for child
care development, and for mental health and to prevent substance abuse
within SAMHSA. HHS was able to leverage existing program mechanisms to
rapidly award funds when they were needed most by the population served
by these critical programs. These large infusions of funds are
supporting state implemented programs to meet both demands and other
challenges presented during the COVID pandemic. Looking forward, HHS
will work within the Administration to identify future investments in
public health programs through the annual budget process taking into
consideration experiences from the COVID response.
Question. The Administration has placed an emphasis on addressing
health equity, especially as it relates to the pandemic response
efforts. What trends are you seeing in rural communities right now with
regard to the pandemic?
How does the HHS' health equity work account for the needs of rural
communities?
Answer. COVID had a disproportionate impact in rural areas given
limited clinical infrastructure (for example, fewer number of beds,
workforce staffing issues already a challenge pre-pandemic, challenges
accessing PPE). Rural communities suffered with high case rates and
high mortality rates, often worse than in urban areas.
HHS has been intentional about targeting COVID relief to rural
communities (and those populations with at higher risk within rural)--
for example HRSA provided funding to grantees in the Mississippi Delta
Region to promote the vaccine, supported regional trainings for
community health workers in that region as well as the region along the
U.S.--Mexico border, programs that have been proven effective in
populations of racial and ethnic minorities that often face even higher
health disparities than the broader rural populations.
Programs this year targeted Rural Health Clinics and small rural
hospitals to support testing and mitigation activities for these key
providers of the rural health safety net. Additionally, funding to
support vaccine distribution and confidence was distributed to Rural
Health Clinics--getting funding to trusted community providers.
We are enhancing our focus on the need to look at rural health
issues through the lens of health equity; expanding the use of our
research centers to gather more data to inform future work in this
area; and providing targeted outreach to key underserved communities
and populations to help them leverage our funding.
Question. Throughout the pandemic, and to date, we have heard
concerns about the impact to the NIH research community. For example,
scientists who had to close their labs and cull their animals lost
valuable research data and post-doctoral candidates couldn't finish
their research in time to get jobs in September. What is the strategy
for using fiscal year 2021 or fiscal year 2022 dollars for COVID-19
related expenses and how much of non-emergency supplemental funding has
been used by agencies to address these concerns?
Answer. As noted in the question, research on many NIH grants was
impacted by the pandemic, causing delays in research activities and
outcomes. NIH is considering various strategies to address these
coronavirus disease 2019 (COVID-19) related expenses to support our
recipients, such as:
--Providing extensions, both funded and un-funded, for recipients of
NIH Fellowship (F) and NIH Career Development (K) awards who
have been impacted by COVID-19 \21\
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\21\ grants.nih.gov/grants/guide/notice-files/NOT-OD-21-052.html.
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--Supporting administrative supplements, competitive revisions, and
extensions to existing grants
--Allowing extensions to one's early-stage investigator status due to
effects related to pandemic shutdowns \22\
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\22\ nexus.od.nih.gov/all/2020/04/09/can-esi-status-be-extended-
due-to-disruptions-from-covid-19/.
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--Temporary extensions of eligibility for select NIH programs,
including the NIH K99/R00 Pathway to Independence Award \23\
---------------------------------------------------------------------------
\23\ NOT-OD-21-158 and NOT-OD-21-106, and those listed on
grants.nih.gov/policy/natural-disasters/corona-virus.htm under
Temporary Extension of Eligibility.
---------------------------------------------------------------------------
--Flexibilities for NIH-funded clinical trials and human subjects for
the duration of the declared public health emergency \24\
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\24\ NOT-OD-20-087 and grants.nih.gov/sites/default/files/
Considerations-New-Ongoing-Human-Subjects-Research-During-the- COVID-
19-Public-Health-Emergency.docx.
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--Flexibilities for assured institutions for activities of
institutional animal care and use committees \25\
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\25\ 25 NOT-OD-20-088.
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The budgetary impact of these flexibilities and additional funding
on new grants funded is not yet fully known. NIH will continue to
analyze the data on the impact of COVID-19 on the biomedical research
community, and its potential impact on our budget and grant activities.
NIH received the authority in Section 152 of the Continuing
Resolution signed into law in September 2020 to extend multi-year
funded grants awarded in fiscal year 2015, specifically for those
active when the COVID-19 public health emergency was declared.\26\ The
project period end dates for those limited number of awards were
extended through August 31, 2021. NIH is also requesting a similar
extended disbursement authority for certain amounts available for
obligation through fiscal year 2016 that were obligated for multi-year
research grants, such that those amounts would continue to be available
through fiscal year 2022.
---------------------------------------------------------------------------
\26\ 26 Section 152. (a) Funds made available in Public Law 113--
235 to the accounts of the National Institutes of Health that were
available for obligation through fiscal year 2015 and were obligated
for multi-year research grants shall be available through fiscal year
2021 for the liquidation of valid obligations incurred in fiscal year
2015 if the Director of the National Institutes of Health determines
the project suffered an interruption of activities attributable to
SARS--CoV--2. (b)(1) This section shall become effective immediately
upon enactment of this Act.
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influenza
Question. Influenza occurs seasonally each year, and has on
occasion caused devastating pandemics in the past. Reports are already
speculating that the next flu season may be bad after a year of hardly
any flu cases. The budget requests an increase of $25 million for CDC
Influenza Planning and Response and an increase of $48 million for
ASPR's Pandemic Flu program. Are these resources sufficient to meet the
needs outlined in the U.S. National Influenza Vaccine Modernization
Strategy, which projected far greater needs over 10 years?
How will the budget request advance the National Strategy?
Answer. The budget request aligns with and supports the pandemic
influenza strategy. The key investments you note are also critical down
payments to incorporate what we are learning in the ongoing COVID-19
response. Specifically, the budget provides $335 million, an increase
of $48 million above fiscal year 2021 enacted, for pandemic influenza
preparedness activities carried out by ASPR and the Office of Global
Affairs (OGA). ASPR will continue to support priorities in the 2019
Executive Order, ``Modernizing Influenza Vaccines in the United States
to Promote National Security and Public Health,'' and apply lessons
learned from the COVID-19 response to improve pandemic influenza
response capabilities. Through established public-private partnerships,
ASPR will advance non-egg-based vaccine platforms, including more
flexible manufacturing technologies (e.g., cell-based and recombinant
technologies) that can produce influenza vaccine more quickly in the
event of a pandemic. The budget also supports the development of
alternative devices for vaccine administration to allow for rapid,
large-scale vaccinations. The COVID-19 pandemic response has
demonstrated the importance of therapeutics that can prevent
progression to severe disease and treat severely ill individuals.
ASPR will continue to support the advanced development of new
influenza therapeutics and diagnostic platforms to allow for earlier
detection and, subsequently, faster treatment of influenza infections.
OGA will continue to enhance international influenza preparedness by
providing strategic coordination and technical expertise on health
policy development and diplomacy to global partners, including nearly
200 Ministries of Health.
In addition, CDC provides technical expertise, resources, and
leadership to support diagnosis, prevention, and control of influenza
domestically and to address the threat posed by seasonal and pandemic
influenza. The fiscal year 2022 Centers for Disease Control and
Prevention budget request invests an additional $25 million to continue
supporting implementation of the influenza planning and response
activities outlined in the 2020-2030 National Influenza Vaccination
Modernization Strategy. These activities include expanding vaccine
effectiveness monitoring and evaluation, enhancing virus
characterization, and expanding vaccine virus development for use by
industry, increasing genomic testing of influenza viruses, and
increasing influenza vaccine use.
______
Questions Submitted by Senator Richard C. Shelby
Question. On August 2, 2019, the Centers for Medicare and Medicaid
Services (CMS) finalized the Inpatient Prospective Payment System
(IPPS) payment rule, which updated Medicare payment policies for
hospitals in states with a low Area Wage Index (AWI). CMS's AWI
calculation has plagued states like Alabama since its inception. Prior
to the IPPS rule being finalized in August 2019, Alabama had the lowest
AWI floor and ceiling of any state in the country, around .66 and .8
respectively. The IPPS rule made formula changes to Medicare's AWI for
fiscal years 2020--2024, which have benefitted several states to this
point, including Alabama, by boosting annual hospital revenue for
Alabama hospitals collectively by $35--$40 million annually, which
saved many rural hospitals from closing their doors prior to the COVID-
19 pandemic.
This is an important issue to all residents of Alabama. The ability
to deliver healthcare in small towns maintains their ability to recruit
businesses to the area. What are your thoughts on the AWI changes that
were made in the fiscal year 2020 IPPS final rule?
Answer. The Inpatient Prospective Payment System (IPPS) pays
hospitals for services provided to Medicare beneficiaries using a
national base payment rate, adjusted for a number of factors that
affect hospitals' costs, including the cost of hospital labor in the
hospital's geographic area. This adjustment, or Area Wage Index, is
updated by CMS annually.
In the fiscal year 2020 IPPS Final Rule,\27\ to help mitigate wage
index disparities between high wage and low hospitals, CMS adopted a
policy to increase the wage index values for certain hospitals with low
wage index values (the low wage index hospital policy). This policy was
adopted in a budget neutral manner through an adjustment applied to the
standardized amounts for all hospitals. CMS also indicated that this
policy would be effective for at least 4 years, beginning in fiscal
year 2020, in order to allow employee compensation increases
implemented by these hospitals sufficient time to be reflected in the
wage index calculation. For fiscal year 2022, CMS is continuing the low
wage index hospital policy.
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\27\ Final Rule (CMS-1716-F) and Correction Notice (CMS-1716-CN2)
available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-
Payment/AcuteInpatientPPS/fiscalyear2020-
IPPS-Final-Rule-Home-Page-Items/fiscalyear2020-IPPS-Final-Rule-
Regulations.
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Question. I understand that the pending fiscal year 2022 IPPS rule
includes some significant policy changes regarding organ
transplantation, which could yield a significant negative impact to
transplant centers. Constituents have told me that the rule was written
without input from stakeholders in the transplant community, without
adequate analysis of the impact to patients' access to transplantation,
and without consideration of budgetary impact, if any, on state
Medicaid/CHIP programs. I am concerned about unintended consequences if
this rule were to go into effect, including to access to care,
especially for the children.
Will you ensure that my concerns will be addressed before this rule
is finalized? Will you also engage with all stakeholders on the issues
I've raised?
Answer. The Medicare Program supports organ transplantation by
providing an equitable means of payment for the variety of organ
acquisition services. I can assure you that CMS will take all comments
and concerns into consideration before issuing a final decision on the
proposed Medicare usable organ counting policy.
Question. The overall budget requests $10.7 billion to fight the
opioid epidemic. Previous Administrations have spent billions of
dollars on all aspects of the epidemic including prevention, research,
education, and treatment and there are still severe issues.
Please provide details as to how the Department plans to spend this
money and how it will have a different impact than the money spent
before.
Answer. The budget takes action to address the epidemic of opioids
and other substance use, investing $11.2 billion, including $10.7
billion in discretionary funding, across HHS, $3.9 billion more than in
fiscal year 2021. The impact of this epidemic is felt in our
communities, and the budget will direct funding to states and Tribes to
increase community-level response. The budget will also increase access
to medications for opioid use disorder and expand the behavioral health
provider workforce, particularly in underserved areas. HHS will
continue to build on the investments the American Rescue Plan provided
to the Substance Abuse Prevention and Treatment Block Grant, Community
Mental Health Services Block Grant, and Certified Community Behavioral
Health Centers. This crisis is evolving--overdose deaths involving
substances other than opioids are also increasing. HHS will ensure our
work is responsive to the needs of communities across the country.
Specifically, the $3.9 billion increase in funding includes:
--FDA: +$38 million above fiscal year 2021, for a total of $113
million, to develop opioid overdose reversal treatments and
treatments for opioid use disorder and continue to support
opioid research efforts.
--HRSA: +$190 million above fiscal year 2021, for a total of $1.1
billion to increase behavioral health workforce grant programs
and expand response to the opioid crisis in rural communities.
--IHS: +$27 million above fiscal year 2021, for a total of $42
million to expand activities that increase access to culturally
appropriate opioid use interventions, including medication-
assisted treatment, for American Indians and Alaska Natives
($15 million) and improve prevention and treatment of Hepatitis
C and HIV in tribal communities ($27 million). The prevalence
of Hepatitis C and HIV in Indian Country is closely linked to
rates of injection drug use.
--CDC: +$244 million above fiscal year 2021, for a total of $733
million to address infectious diseases associated with
injection drug use and expand opioid overdose prevention
programs to communities heavily impacted by the overdose
crisis. The additional resources will support collection and
reporting of real-time, robust mortality data and investments
in prevention for people put at highest risk as well as for
testing, diagnosis, linkage to care, and treatment for
infectious diseases related to injection drug use.
--NIH: +$627 million above fiscal year 2021, for a total of $2.2
billion to increase opioid, stimulant, and substance use
research. Within this total, $811 million supports the Helping
to End Addiction Long-term (HEAL) Initiative, NIH's aggressive,
trans-agency effort to provide scientific solutions to the
opioid crisis. Over $1.4 billion supports ongoing research in
this critical area.
--SAMHSA: +$2.7 billion above fiscal year 2021, for a total of $6.8
billion to increase funding for SAMHSA block grants and grant
programs directing funding to local public health response to
the substance use and opioid crisis, including Certified
Community Behavioral Health Clinics. This increase also will
expand access to treatment for pregnant and post-partum women,
access to medication-assisted treatment, access to recovery
support services, and access to drug treatment activities.
--AHRQ: +$7 million above fiscal year 2021, for a total of $10
million for new research grants to increase equity in substance
use disorder (SUD) treatment access and outcomes, accelerate
the implementation of effective evidence-based care in primary
and ambulatory care, and develop whole person models of care
that address the social factors that shape SUD treatment
adherence and long-term recovery.
--CMS: +$12.9 million above fiscal year 2021, for a total of $16.3
million, to increase opioid activities, including funding
certain SUPPORT Act provisions. The funding requested will be
used for data and information technology needs, provider
education, monitoring and auditing, performance measurement,
and claims analysis. CMS will continue to provide technical
assistance to states on behavioral health, developing an
updated opioid and SUD Action Plan, working with the Office of
National Drug Control Policy on the National Drug Control
Strategy, and collaborate with other HHS operating divisions on
opioid and SUD actions, behavioral health, and pain
initiatives.
--ACF: +$40 million above fiscal year 2021, for a total of $140
million to increase state child abuse prevention grant funding
focusing on developing infant safe care plans and expansion of
kinship navigator and regional partnership grants which assist
families at risk due to substance use of a family member.
--ACL: +$1 million above fiscal year 2021, for a total of $3 million
to increase grants for adult protective services and opioid-
related activities to maximize the impact on direct services to
the most affected clients.
The fiscal year 2022 President's Budget provides $713 million for
CDC's opioid overdose prevention and surveillance activities, which is
an increase of $239 million from fiscal year 2021. With the support of
Congress and increases in appropriations in previous years, CDC has
scaled its overdose surveillance and prevention program from 5 states
in 2014 to 47 states, 16 localities, and two territories today.
With the fiscal year 2022 increased funding request, CDC would
continue improving the timeliness and comprehensiveness of drug
overdose data and scaling overdose prevention strategies, evaluation,
and applied research. Because successful response strategies must be
tailored to local communities, CDC would also use the increased funding
to scale local investments so more local communities can quickly
identify changes in local drug supply and prevent overdoses. The
increased funding would also support states and communities that
require additional resources to respond to an increase in overdoses due
to the COVID-19 pandemic.
Question. After significant investment over the past several years,
state Prescription Drug Monitoring Programs (PDMPs) are still not real-
time, not interoperable, and are not incorporated into a provider's
workflow, yet the technology exists to fix all these issues. How does
your budget support improvements to PDMPs and will any funds
specifically support upgrading these systems to address the concerns
I've outlined?
Answer. CDC's goal is to maximize interconnectivity of all
resources within this space. CDC's Overdose Data to Action (OD2A)
program expanded previous Prescription Drug Monitoring Program (PDMP)
investments and has worked to make PDMPs easier to use and more
accessible to both clinicians and under-resourced communities. Under
OD2A, required activities related to PDMPs include:
--Universal use among providers within a state
--Inclusion of more timely or real-time data contained within a PDMP
--Actively managing the PDMP in part by sending proactive or
unsolicited reports to providers to inform prescribing
--Ensuring that PDMPs are easy to use and access by providers
--Propose activities to enhance and maximize the use of PDMPs, such
as moving towards real-time data collection
In addition to the base OD2A funding provided to recipients to
implement required PDMP activities, states were provided with the
option to apply for additional funds to make PDMP data more actionable
both within and across state borders. Activities under this
supplemental funding include integrating state PDMPs with other health
systems data and integrating the PDMP across state lines/interstate
operability.
With Federal funding and substantial technical assistance provided
by CDC, the Bureau of Justice Administration (BJA), the Centers for
Medicaid & Medicare Services (CMS),SAMHSA, and the Office of the
National Coordinator for Health Information Technology (ONC), states
have made significant strides in reporting data faster and achieving
interstate and intrastate PDMP operability, most commonly via the
RxCheck hub or PMP Interconnect. As of May 2021, there are 46
jurisdictions that are live on the RxCheck hub and actively able to
share data across state lines. PMP Interconnect, from the National
Association of Boards of Pharmacy, currently includes 51 participating
jurisdictions. In addition to those jurisdictions sharing data across
states, 45 states and territories are also engaged in intrastate
integration with electronic health records (EHRs), Health Information
Exchanges (HIEs), and Pharmacy Dispensing Systems. CDC collaborated
with other Federal partners to support PDMP/EHR integration in states
through several different projects, including OD2A. CDC also
collaborated with Office of the National Coordinator for Health
Information Technology to select three states (Kentucky, Utah, and
Illinois) as pilots to demonstrate how to integrate PDMP data with EHR
information through the RxCheck Hub.
Currently, only the Oklahoma PDMP has real-time data reporting.
However, 49 state, district, and territory PDMPs have daily or next day
reporting. CDC and BJA funds continue to help states report data
faster. For example, Maine is moving towards real-time PDMP reporting
by using CDC funds to support reporting dispensed controlled substances
no later than the next business day. With fiscal year 2022 funds, CDC's
OD2A program will continue supporting states to improve PDMPs and
maximize interconnectivity. CDC will also support states to increase
data sharing within states, particularly increasing PDMP data within
EHRs and HIEs.
Question. What are your thoughts on continuing the CMS issued
flexibilities around telehealth once the Public Health Emergency has
ended?
Answer. Telehealth is an important tool to improve health equity
and improve access to healthcare. Healthcare should be accessible, no
matter where you live. HHS continues to examine the telehealth
flexibilities developed for the current public health emergency and
determine how we can build on this work to improve health equity and
improve access to healthcare. In addition to looking at which
flexibilities HHS can and should continue administratively, I look
forward to working with Congress to address changes that may need to be
done through legislation.
______
Questions Submitted by Senator Jerry Moran
Question. Before turning to the fiscal year 2022 budget request, I
would like to discuss the remaining money in the Provider Relief Fund.
According to May data from the Health Resources and Services Agency,
there is around $24 billion left in the PRF plus the additional $8.5
billion allocated to rural healthcare providers in the American Rescue
Plan. While HHS has rolled out programs using some of the remaining PRF
funding, I want to ensure the PRF is still serving its original purpose
of protecting healthcare facilities.
Are you considering allocating any of the remaining PRF funds to
assist rural hospitals who may still be struggling in the aftermath of
the pandemic?
Answer. HHS is committed to distributing the remaining provider
relief payments as quickly, transparently, and equitably as possible
while utilizing effective safeguards to protect taxpayer dollars. HHS
is planning for future Provider Relief Fund (PRF) allocations,
including the $8.5 billion from American Rescue Plan Act and Phase 4 of
the General Distribution.
HHS is actively considering feedback from stakeholders, as well as
operational lessons learned from prior PRF payments, as part of the
planning process. The feedback from Members of Congress and other
stakeholders informs HHS' ability to administer the PRF in a manner
that bolsters the healthcare system and helps providers experiencing
COVID-related financial hardships during this crisis. HHS will publish
additional information on future distributions on the Health Resources
and Services Administration's PRF webpage, at www.hrsa.gov/provider-
relief, as soon as it becomes available.
Question. The CARES Act established the PRF to prevent hospitals
from closing during the most severe pandemic mitigation measures and
rural hospitals in particular needed this financial assistance. While
the PRF was largely successful, hospitals that opened in late 2019 did
not receive enough relief and are now strapped for cash. Rock Regional
in Derby, Kansas, which opened just months before the pandemic in 2019,
is one such hospital that deserves more PRF funding under the
guidelines of the Consolidated Appropriations Act of 2021.
Would you consider reopening Phase 3 PRF applications to accept
updated documentation consistent with guidelines of the Consolidated
Appropriations Act?
Answer. In processing PRF applications, HHS has sought to make
payments as quickly and equitably as possible while taking appropriate
precautions to safeguard taxpayer dollars. HHS recognizes that
providers may have questions regarding the accuracy of their PRF
payments. HHS will provide any updates on Phase 3 payments on the
Health Resources and Services Administration's PRF webpage, at
www.hrsa.gov/providerrelief, as soon as they becomes available.
Question. Given the purpose of the PRF, if hospitals are still
struggling, that ought to lead to consideration of a Tranche 4
targeting such healthcare facilities, especially those that opened in
2019.
Is this something you will consider as you look at allocating the
remaining PRF funding?
Answer. As HHS plans for future Provider Relief Fund (PRF)
allocations, including the $8.5 billion from American Rescue Plan Act
and Phase 4 of the General Distribution, we are cognizant that
hospitals that began operating in 2019 and 2020 are facing unique
financial burdens related to the pandemic. Under the previous PRF
distribution payment methodology, HHS paid new providers based on the
average lost revenues and increased expenses for their provider type to
avoid disadvantaging these entities.
As we move forward, HHS is actively considering feedback from
stakeholders, as well as operational lessons learned from prior PRF
payments, as part of the planning process for future funding. The
feedback from Members of Congress and other stakeholders informs HHS'
ability to administer the PRF in a manner that bolsters the healthcare
system and helps providers experiencing COVID-related financial
hardships during this crisis.
HHS will publish additional information on future distributions on
the Health Resources and Services Administration's PRF webpage, at
www.hrsa.gov/provider-relief, as soon as it is available.
Question. I have been concerned with the challenges that the senior
living community has faced throughout the duration of the pandemic.
Long-term care and assisted living facilities were tasked with caring
for the population most vulnerable to COVID-19. In caring for the over
two million seniors across the country, these facilities faced
increasing costs in protecting residents and their staff. As you have
heard me mention before, these senior living facilities have not been
receiving enough support from HHS and are in need of assistance.
Can you confirm that senior and assisted living facilities will
actually see meaningful financial support from the remaining Provider
Relief Fund money in a timely manner?
Answer. As of June 4, 2021, over 10 percent of the total PRF
payments made and kept by providers were directed to nursing homes,
assisted living facilities, and skilled nursing facilities, including
more than $9 billion in PRF Targeted Distribution payments and over $3
billion in PRF General Distribution payments to provider organizations
with at least one nursing home, skilled nursing facility, assisted
living facility, or long term care facility.
HHS appreciates the care being given to seniors across the nation
and recognizes that some assisted living facilities are still
experiencing financial burdens related to the pandemic. HHS is
committed to distributing the remaining provider relief payments as
quickly and equitably as possible while utilizing effective safeguards
to protect taxpayer dollars. At present, HHS is planning a Phase 4 of
the General Distribution. Congress also appropriated an additional $8.5
billion, which has not yet been obligated, in the American Rescue Plan
Act for Medicare and Medicaid providers and suppliers in rural areas or
who serve rural patients.
HHS is actively considering feedback from stakeholders, as well as
operational lessons learned from prior PRF payments, as part of the
planning process. The feedback from Members of Congress and other
stakeholders informs HHS' ability to administer the PRF in a manner
that bolsters the healthcare system and helps providers experiencing
COVID-related financial hardships during this crisis. HHS will publish
additional information on future distributions on the Health Resources
and Services Administration's PRF webpage, at www.hrsa.gov/provider-
relief, as soon as it becomes available.
Question. I would like to ask about your approach to Community
Health Centers. Health Centers in Kansas have been among the leaders in
responding to the COVID-19 pandemic. Since the beginning of the year,
Kansas Health Centers have tested nearly 20,000 patients and
administered vaccines for over 48,000 patients. The fiscal year 2022
budget request mentions the Administration looks forward to working
with Congress to advance the President's goal of doubling the Federal
investment in community health centers. However, the budget also
included a $45 million cut to the overall program due to budget
sequestration.
Could you please discuss HHS' support for greater health center
funding and how you intend to work with Congress to double Federal
investments in community health centers?
Answer. HRSA supports the President's goal to double the Federal
investment in community health centers and looks forward to working
with Congress to expand the Health Center Program to: (1) increase
access to primary medical care services in the high need communities;
(2) ensure that health center patients receive a full range of
comprehensive primary healthcare services; (3) improve health outcomes
and reduce health disparities through new, evidence-based and
innovative approaches to care; and (4) invest in local healthcare
infrastructure and expand employment opportunities in medically
underserved communities.
Question. As I'm sure you're aware, the Children's Hospital
Graduate Medical Education (CHGME) program supports the specialized
training that occurs in many children's hospitals. For example,
Children's Mercy in Kansas City trains the majority of pediatricians
that serve the state of Kansas, instructing nearly 230 pediatric
residents and fellows annually. The fiscal year 2022 budget request
included $350 million for CHGME, marking the first time since fiscal
year 2021 the budget request included a separate request for CHGME.
Could you expand on HHS' goals for the separate funding request and
fiscal year 2022 increase for the CHGME?
Answer. The budget requests $350 million for CHGME to provide
continued support for the pediatric workforce. The funding amount of
$350 million aligns with the fiscal year 2021 enacted funding level and
is expected to support approximately 7,700 resident full-time
equivalents (FTEs). CHGME payments are for direct and indirect medical
expenses for medical residency training programs. The funding will also
support contracts to meet legislative requirements such as the FTE
reconciliation which ensures correct reporting and that residents are
not funded by other Federal programs to prevent duplicate payments.
______
Questions Submitted by Senator John Kennedy
Question. A recent report indicated that HHS has approximately $24
billion in unspent CARES funding. Many healthcare providers are still
working their way through the financial effects of the COVID-19
pandemic, and this funding is crucial.
Can you indicate if healthcare providers, including air ambulances,
can expect to see this funding made available, or will you be returning
unspent CARES funding so that we can reduce the overall financial
impact of spending related to the pandemic response?
Answer. HHS is committed to distributing the remaining provider
relief payments as quickly, transparently, and equitably as possible
while utilizing effective safeguards to protect taxpayer dollars. HHS
is planning for future Provider Relief Fund (PRF) allocations.
HHS is actively considering feedback from stakeholders, as well as
operational lessons learned from prior PRF payments, as part of the
planning process. The feedback from Members of Congress and other
stakeholders informs HHS' ability to administer the PRF in a manner
that bolsters the healthcare system and helps providers experiencing
COVID-related financial hardships during this crisis. HHS will publish
additional information on future distributions on the Health Resources
and Services Administration's PRF webpage, at www.hrsa.gov/provider-
relief, as soon as it becomes available.
Question. If HHS is going to retain unspent CARES Act funds, can it
be used to waive recoupment of Medicare Advanced Payments?
Answer. HHS is committed to distributing the remaining provider
relief payments as quickly, transparently, and equitably as possible
while utilizing effective safeguards to protect taxpayer dollars. HHS
is planning for future Provider Relief Fund (PRF) allocations.
As we move forward, HHS is actively considering feedback from
stakeholders, as well as operational lessons learned from prior PRF
payments, as part of the planning process for future funding. The
feedback from Members of Congress and other stakeholders informs HHS'
ability to administer the PRF in a manner that bolsters the healthcare
system and helps providers experiencing COVID-related financial
hardships during this crisis.
HHS will publish additional information on future distributions on
the Health Resources and Services Administration's PRF webpage, at
www.hrsa.gov/provider-relief, as soon as it is available.
______
Questions Submitted by Senator Cindy Hyde-Smith
Question. Secretary Becerra, new data has just been released by
NORC at the University of Chicago finding that nearly two-thirds of
assisted living facilities reported no deaths from COVID-19 in 2020.
Despite this positive data, some have expressed concerns assisted
living providers caring for nearly 2 million elderly individuals have
received less than 1 percent of all provider relief funding to date. It
is my understanding that assisted living providers expended a great
deal of capital in order to ensure COVID-19 safety in their facilities,
as well as to compete for staffing in a tight nursing labor market. I
have been informed that assisted living caregivers will suffer $30
billion in losses through June 2021 due to these efforts and that over
half of assisted living facilities nation-wide are operating at a loss
currently.
How can HHS help support these assisted living providers, through
the PRF and otherwise?
Answer. As of June 4, 2021, over 10 percent of the total PRF
payments made and kept by providers were directed to nursing homes,
assisted living facilities, and skilled nursing facilities, including
more than $9 billion in PRF Targeted Distribution payments and over $3
billion in PRF General Distribution payments to provider organizations
with at least one nursing home, skilled nursing facility, assisted
living facility, or long term care facility.
HHS appreciates the care being given to seniors across the nation
and recognizes that some assisted living facilities are still
experiencing financial burdens related to the pandemic. HHS is
committed to distributing the remaining provider relief payments as
quickly and equitably as possible while utilizing effective safeguards
to protect taxpayer dollars.
HHS is actively considering feedback from stakeholders, as well as
operational lessons learned from prior PRF payments, as part of the
planning process. The feedback from Members of Congress and other
stakeholders informs HHS' ability to administer the PRF in a manner
that bolsters the healthcare system and helps providers experiencing
COVID-related financial hardships during this crisis. HHS will publish
additional information on future distributions on the Health Resources
and Services Administration's PRF webpage, at www.hrsa.gov/provider-
relief, as soon as it becomes available.
Question. Your budget calls for the elimination of the Hyde
Amendment to allow taxpayer funding of abortion through Medicaid,
Medicare, and other programs under Labor/HHS appropriations.
Why is this Administration insistent on reversing four decades of
bipartisan precedent and ignoring the will of most Americans who object
to their tax dollars funding the destruction of human life?
Answer. The Hyde Amendment disproportionately impacts the growing
number of low-income, women of color who are enrolled in Medicaid, and
is a barrier to expanding access to healthcare. That is why the
President's first budget calls for Congress to remove the restriction
from government spending bills.
The Department of Health & Human Services implements the laws that
Congress passes. Implementation of any changes in coverage related to
the President's Budget would depend on the final language Congress
passes. After passage of any legislation, agency staff and counsel
review the language to determine the agency's authority and options for
implementation action, such as initiating notice and comment rulemaking
or issuing guidance documents.
Question. Your budget proposes a 19 percent increase in funding for
the Title X family planning program by $53.521 million to $340 million
from $286.479 million. I am concerned that Title X will be a slush fund
for Planned Parenthood and the abortion industry.
Can you ensure that these new funds will not be used to bolster
abortion giant Planned Parenthood and its cohorts?
Answer. The Title X program does not provide abortion services.
Section 1008 of the Public Health Service Act specifically states that
``None of the funds appropriated under this title shall be used in
programs where abortion is a method of family planning.'' Consistent
with the program's statute and regulations, any public or private
nonprofit organizations, including faith-based organizations, state,
county, local, and tribal governments, school districts, and public and
state higher education institutions are eligible to apply for Title X
grant funds. Title X's regulations, in the NPRM, also clearly define
the criteria the Department uses to decide which family planning
services projects to fund and in what amount.
Question. As you know, the previous administration disallowed $200
million in Medicaid funds from California because it was literally
forcing nuns to buy abortion insurance in violation of conscience
protection laws.
Will you commit to not reversing the findings made by career
professionals supporting the disallowance and not otherwise restoring
the money to California?
Answer. In my ethics agreement signed on January 17, 2021, and the
subsequent authorization issued on March 31, 2021, I have agreed not to
participate in any litigation involving the State of California that
was pending during my tenure as Attorney General. I understand that
there has been no litigation on this matter, however, as Attorney
General I did issue a public statement on the matter. After consulting
with the HHS Acting Designated Agency Ethics Official, I have
determined that it is prudent for me to recuse myself from this
Medicaid financing matter to avoid even an appearance of impropriety. I
trust that the very talented employees of the Department who, at the
working level, handle the vast amounts of work, including specific
enforcement and program financing matters, will resolve this matter in
a manner that is consistent with the Department's obligations and in
the best interest of the American people. If leadership input is
required, the Chief of Staff will either handle the case without any
input from me or will refer the case to the appropriate person for
decision.
Question. Your budget asks for a $9 million increase for the Office
for Civil Rights (OCR), yet OCR inherited over $60 million in
enforcement settlement funds that you are free to use right now to
support the bulk of OCR operations.
Do you think it is appropriate for you to ask Congress for more
taxpayer money for an Office that is sitting on such a huge sum of
money?
Answer. The Health Insurance Portability and Accountability Act of
1996 ( HIPAA) law requires the Office for Civil Rights (OCR) to spend
any money that it collects in HIPAA settlements on HIPAA enforcement
only. This means that these funds are limited in their use as directed
by Congress.
The proposed increase in OCR's budget would support civil rights
authorities and operations, specifically working on improving overall
enforcement stemming from OCR's authority over healthcare.
Question. Will you commit to preserving the Conscience and
Religious Freedom Division as a Division within OCR?
Answer. HHS will continue to protect the religious, civil, and
constitutional rights of all Americans. This means that we will
continue to enforce conscience and religious freedom protections,
including receiving complaints, investigating cases, and making
findings consistent with the law.
Question. A few weeks ago you announced that HHS will interpret
prohibitions on sex discrimination in healthcare to include ``sexual
orientation and gender identity.''
As I read your announcement, male or female are no longer to be
understood as being based on biology. What does it mean to be a man or
a woman going forward under these laws?
Under your announcement, do doctors, who receive HHS funding, have
a right to decline to perform procedures that violate their religious
beliefs or conscience?
Do you favor HHS funds being available for sex-reassignment
surgeries in minors? If so, please explain your justification under
current Federal law.
Do you favor HHS funds being available for puberty blockers and
cross-sex hormones for young children? If so, please explain your
justification under current Federal law.
Answer. HHS will continue to protect the religious, civil,
constitutional rights of all Americans.
Question. As of this week over 60 percent of Americans have
received at least one dose of the COVID-19 vaccine. This extraordinary
milestone was made possible by the unprecedented speed of developing a
vaccine less than 1 year after the start of the COVID-19 pandemic.
However, when the next pandemic hits, the U.S. will need to move even
faster. With the frequency of epidemics and pandemics increasing, the
next fast-moving, novel infectious disease pandemic could occur within
the next 10 years. In addition to naturally occurring threats, rapid
advances in biotechnology increase the chance that novel pathogens
could be created with the potential to start major outbreaks. Given the
uncertainty about how the next pandemic will arise, we must harness
innovative technologies, outside the box thinking, and game changing
science to develop countermeasures that are pathogen-agnostic. In the
fiscal year 2021 House and Senate Committee Reports we included
language that encouraged the Department to work with the Department of
Defense to implement a dedicated medical countermeasures program
focused on developing flexible vaccines and antiviral treatments to
address emerging and previously unidentified infectious disease
threats, referred to as Disease X.
Mr. Secretary, what progress has the Department made in
implementing such a program?
How is the Department planning to develop countermeasures for
previously unidentified viral threats?
Answer. The U.S. Department of Health and Human Services recognizes
the importance of developing flexible, broadly applicable technologies
for the development of medical countermeasures, especially vaccines, to
be able to respond quickly to emerging infectious diseases. The
development of highly adaptable vaccine platforms and structural
biology tools enabling the design of novel and improved immunogens have
helped usher in a new era of vaccinology. In addition, the development
of broadly acting antivirals and other therapeutics will be critical as
we prepare to respond to a future Disease X.
The National Institute of Allergy and Infectious Diseases (NIAID)
at the National Institutes of Health (NIH) supports and conducts
research to both identify previously unidentified viral threats and to
develop medical countermeasures that can be used to respond to them. On
August 27, 2020, NIAID established the Centers for Research in Emerging
Infectious Diseases (CREID), a multidisciplinary global network that
seeks to identify how and where viruses and other pathogens emerge from
wildlife and spillover to cause disease in people. The CREID network,
along with other U.S. Government funded global surveillance efforts,
will enable early warnings of emerging diseases wherever they occur,
facilitate a coordinated outbreak response to an emerging virus, and
may be a crucial tool in early identification of a future Disease X
with pandemic potential. This program will build upon prior U.S.
Government efforts in global disease surveillance and complement
important ongoing activities supported by Federal partners.
NIAID supports basic, translational, and clinical research to
develop novel medical countermeasures, including novel vaccine
platforms, adjuvants, and directly acting oral antivirals. These
medical countermeasures are often developed for broad pathogen families
and can be quickly modified for efficacy against related emerging
pathogens with pandemic potential. NIAID also makes available to the
broader research community a suite of preclinical services that can
help lower the risk to developers and help to advance novel
diagnostics, therapeutics, and vaccines. In addition, NIAID has
leveraged and strengthened global and domestic clinical research
networks to facilitate preparedness for rapid launch of clinical trials
in outbreak situations. These long-standing NIAID investments were
crucial to the response to the emergence of severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19.
For example, the NIAID Vaccine Research Center played a key role in
both the development of novel vaccine platforms and the design of the
stabilized prefusion spike protein immunogen used in all three of the
COVID-19 vaccines currently authorized under an Emergency Use
Authorization from the FDA. The development--in record time--of these
highly efficacious vaccines with the potential for saving millions of
lives was only possible through an extraordinary multidisciplinary
effort leveraging decades of basic, preclinical, and clinical science.
NIH- and NIAID-supported advances in medical countermeasure
research and development, as well as other efforts across HHS to
prepare for novel disease threats, were vital to the Federal response
to COVID-19. Throughout the COVID-19 pandemic, NIH has supported HHS'
efforts to leverage highly productive public-private partnerships with
industry, academia, and the public-sector; utilize longstanding
relationships with community partners to facilitate the biomedical
research response; and engage existing domestic and international
research infrastructure to respond to COVID-19. The whole-of-government
approach that began under Operation Warp Speed and has continued under
the current HHS and Department of Defense Countermeasure Acceleration
Group partnership has efficiently supported the development of safe and
effective COVID-19 medical countermeasures. This effort led to the
rapid identification and clinical testing of candidate therapeutics for
the treatment of COVID-19, as well as multiple COVID-19 vaccine
candidates that progressed in record time from concept to FDA emergency
use authorization. Lessons learned from the Federal response to COVID-
19 will be used to inform future pandemic preparedness efforts at NIH
and across HHS.
In addition to developing platforms that allow for the accelerated
development of vaccines for emerging pathogens, there is a need to move
beyond chasing the different viral strains or variants as they emerge.
NIAID is leading efforts to develop ``universal'' influenza vaccines to
protect against multiple strains of seasonal and pandemic influenza
viruses that may emerge. NIAID also is conducting early-stage research
on the development of pan-coronavirus vaccines designed to provide
broadly protective immunity against multiple coronaviruses, especially
SARS-CoV-2 and others with pandemic potential. New viral threats will
continue to emerge, and the development of universal influenza vaccines
and pan-coronavirus vaccines will help us be better prepared for future
infectious disease threats.
Gaining a deeper understanding of the interplay between pathogens
and the human immune system also could expedite the development of
medical countermeasures against emerging pathogens. NIAID supports a
number of research initiatives to define human immune mechanisms that
provide protective anti-viral immunity or contribute to disease
pathogenesis. For example, the NIAID Vaccine Research Center is
establishing the Pandemic Response Repository through Microbial/Immune
Surveillance and Epidemiology (PREMISE) program. This program will use
data from T and B cell immune surveillance to inform diagnostic,
prophylactic, and therapeutic countermeasures and accelerate the global
response to pandemic threats. NIAID anticipates the research conducted
by PREMISE, and other similar NIAID initiatives, will advance our
knowledge of the immune response to vaccination and infection and help
inform the response to future pandemic threats.
The COVID-19 pandemic is an important reminder of the value of
sustained and robust support for the U.S. biomedical research
enterprise, which continues to accelerate the development of medical
countermeasures to protect against emerging and re-emerging infectious
diseases. NIH remains committed to working with our partners across the
Federal Government to continue advancing the research that will help us
respond to future pandemic threats from Disease X. NIAID will continue
to support the development of flexible vaccine platforms, novel
adjuvants, and antiviral treatments to address emerging and previously
unidentified infectious disease threats. NIAID also anticipates
launching new initiatives focused on preparing for future pandemic
threats from Disease X. These initiatives will continue to build on
long-standing NIAID efforts in this area, as well as lessons learned
from the research response to COVID-19.
Question. As you know from your previous role as a Member of the
Ways and Means Committee, chronic kidney disease (CKD) is unique to
Medicare in that individuals with irreversible kidney failure are
eligible for Medicare regardless of age or other disability. Over its
nearly 50-year existence, this unique coverage has saved tens of
thousands of lives, including 750,000 Americans who currently are on
dialysis or who have a functioning kidney transplant. Individuals with
chronic kidney disease cost Medicare $130 billion in fee-for-service
spending per year, almost $50 million of which is for patients with
irreversible kidney failure. Kidney failure patients represent 1
percent of Medicare beneficiaries but 7 percent of FFS expenditures.
Improving detection and care of early stage CKD can help reduce health
expenditures and improve patients' lives, yet an estimated 90 percent
of our nation's 37 million adults with CKD are unaware they have it.
How will you prioritize changes at your Department to expand the
focus on awareness, early detection, and early treatment to help
prolong kidney function and help ensure the solvency of Medicare?
Nearly 20 years ago, the CDC created the Chronic Kidney Disease
Initiative to increase awareness of the disease and expand public
health surveillance activities. Unfortunately, funding has been mostly
stagnant throughout its history, and it currently receives only $2.6
million, despite the tremendous cost of CKD to society, Medicare, and
Medicaid. The previous Administration created the Advancing American
Kidney Health Initiative, which was very favorably received by the
kidney community. One of the most important goals of AAKH, correlating
to the CDC kidney initiative, was to increase awareness and early
detection of kidney disease via a national kidney disease awareness
public health initiative.
Please comment on efforts to expand the Chronic Kidney Disease
Initiative to meet this awareness and early detection need.
COVID-19 has disproportionately affected kidney patients, who have
experienced some of the highest rates of hospitalization and mortality
from the pandemic. Additionally, COVID-19 is linked to acute kidney
injury (AKI) and to kidney disease in recovering COVID-19 patients who
have no prior history of kidney disease. A March 2021 study from Yale
University indicates that AKI occurred in up to 57 percent of COVID-19
hospitalizations and 78 percent of intensive care unit admissions. In
addition, reports from early in the pandemic indicate that barely a
third of patients who developed AKI had not yet recovered baseline
kidney function at a median of 21 days after leaving the hospital.
(https://www.ajmc.com/view/study-illustrates-kidney-impact-after-covid-
19-resolves)
Without intervention, these patients could develop chronic kidney
disease. What steps will HHS take to ensure COVID-19 patients have
access to the kidney services and care they need going forward?
Answer. Many beneficiaries with end-stage renal disease (ESRD)
suffer from poor health outcomes and face increased risk of
complications with underlying diseases. For example, people with ESRD
who get coronavirus disease 2019 (COVID-19) have higher rates of
hospitalization. Last year, CMS established the End-Stage Renal Disease
(ESRD) Treatment Choices (ETC) Model, a mandatory Medicare payment
model tested under the authority of section 1115A of the Social
Security Act. The ETC Model tests the use of payment adjustments to
encourage greater utilization of home dialysis and kidney transplants,
in order to preserve or enhance the quality of care furnished to
Medicare beneficiaries while reducing Medicare expenditures. This
payment model is expected to encourage participating healthcare
providers to invest in and build their home dialysis programs, allowing
patients to receive care in the comfort and safety of their home. Home
dialysis gives patients the freedom to choose the therapy that works
best with their lifestyles, without being tied to the dialysis
facility's schedule. The ETC Model also includes financial incentives
for participating ESRD facilities and clinicians to encourage
transplantation based on their transplant rate, calculated as the sum
of the transplant waitlist rate and the living donor transplant rate.
Increasing access to affordable coverage will increase access to
care, including preventive services and treatments that prolong kidney
function. The President's fiscal year 2022 Budget includes numerous
provisions that would work together to give Americans additional,
lower-cost coverage options. One provision would give people age 60 and
older the option to enroll in the Medicare program with the same
premiums and benefits as current beneficiaries, but with financing
separate from the Medicare Trust Fund. In States that have not expanded
Medicaid, the President has proposed extending coverage to millions of
people by providing premium-free, Medicaid-like coverage through a
Federal public option.
Question. Sec Becerra, as you know, influenza occurs seasonally
each year and throughout history has caused devastating pandemics--
including the 1918 pandemic that killed an estimated 675,000 Americans.
While this year's flu season was extremely mild, next year's could be
much worse. The U.S. National Influenza Vaccine Modernization Strategy
was released 1 year ago, with an ambitious vision of a domestic
influenza vaccine enterprise that is highly responsive, flexible,
scalable, and more effective at reducing the impact of seasonal and
pandemic influenza viruses. The HHS Budget included a $25 million
increase within CDC's Influenza Division and a $48 million increase for
ASPR Pan Flu.
Are these resources sufficient? The previous administration
estimated $1billion over 10 years would be needed to sufficiently
resource the Strategy.
Answer. ASPR/BARDA has a long and successful history of focused
efforts to invest in increasing influenza vaccine production capacity
in preparation for a pandemic influenza response. While these efforts
benefit seasonal influenza (e.g., cell-based vaccine, recombinant
protein vaccine), they are not specific for seasonal influenza. In
2020, ASPR/BARDA also worked with industry to develop respiratory panel
diagnostics that test for influenza and SARS-CoV-2 infection
simultaneously. ASPR/BARDA looks forward to continuing these efforts as
part of the National Influenza Vaccine Modernization Strategy and
working with our colleagues at NIAID supporting early development of a
universal influenza vaccine.
Question. Sec Becerra, the Administration has requested $30 billion
over 4 years in mandatory funding to protect Americans from the next
pandemic. According to the latest budget request, $24 billion of that
would be allocated to HHS for medical countermeasures manufacturing and
other initiatives.
Please elaborate on the need for this $30 billion investment.
Answer. The President's request for $30 billion over 4 years would
help protect Americans from future pandemics through major new
investments in medical countermeasures manufacturing; research and
development; and related biopreparedness and biosecurity. This includes
investments to shore up our nation's strategic national stockpile;
accelerate the timeline to research, develop and field tests and
therapeutics for emerging and future outbreaks; accelerate response
time by developing prototype vaccines through Phase I and II trials,
test technologies for the rapid scaling of vaccine production, and
ensure sufficient production capacity in an emergency; enhance U.S.
infrastructure for biopreparedness and investments in biosafety and
biosecurity; train personnel for epidemic and pandemic response; and
onshore active pharmaceutical ingredients. COVID-19 has claimed
hundreds of thousands of American lives and cost trillions of dollars,
demonstrating the devastating and increasing risk of pandemics and
other biological threats. The American Rescue Plan serves as an initial
investment of $10 billion. With this new major investment in preventing
future pandemics, the United States will build on the momentum from the
American Rescue Plan, bolster scientific leadership, create jobs,
markedly decrease the time from discovering a new threat to putting
shots in arms, and prevent or mitigate future biological catastrophes.
Question. Will any of these funds be targeted at influenza, which
has the potential for a pandemic even more devastating than Covid-19?
Answer. HHS will follow the requirements spelled out in statute and
follow the latest science in directing resources toward current and
future pandemics.
Question. Please also provide greater clarity into how those funds
would be allocated within HHS.
Answer. HHS is thankful for the resources provided by Congress to
address the COVID-19 pandemic. We will follow the statutory
requirements for use of funds appropriated to HHS and take a broad
approach to addressing COVID-19 by continuing to support research on
prevention, therapeutics, and vaccines; supporting workforce expansion
to ensure equitable distribution of vaccines and therapeutics;
investing in testing and screening to allow our schools and businesses
to remain open; addressing our supply chain and manufacturing
challenges; as well as addressing the mental health of those affected
by COVID-19 whether they lost a family member or friend, suffered
COVID-19, or lost the ability to fully participate in significant life
events over the past 18 months or more. We will invest in the science
and follow the science during this unprecedented time and do our best
to address the challenges it has brought to our public health
infrastructure.
Question. One of the silver linings of this pandemic has been the
wide-spread adoption of technology to bring people together, whether it
be families scattered across the nation or patients and their
providers. We have seen exponential growth in telehealth adoption
across Americans of all ages, locations, and conditions. Telehealth
among Medicare beneficiaries has been made possible by temporary
flexibilities in place for the duration of the public health emergency.
These include allowing Medicare beneficiaries to have telehealth
visits from their home, regardless of where they live across the
country. This has also allowed new types of providers, such as physical
therapists and speech pathologists to practice via telehealth.
Sec. Becerra, do you agree that access to telehealth has been
critical to protecting patients and providers during the nation's
response to COVID-19? b.Sec. Becerra, do you agree that providers and
beneficiaries have seen immense value from expanded access to
telehealth over the past year? Do you agree that Americans have been
overwhelming satisfied with care received virtually during the
pandemic?
Sec. Becerra, can you tell us where telehealth ranks in terms of
your priorities? d.Sec. Becerra, how can Congress ensure that Medicare
beneficiaries do not lose access to telehealth after the public health
emergency expires?
Will you commit to working with Congress to ensure that the
millions of Medicare beneficiaries enrolled in fee-for-service Medicare
do not face a telehealth service coverage cliff when the public health
emergency expires?
Sec. Becerra, as Congress considers permanent telehealth reform, we
will need your support, including an evidence-based assessment of how
many of the telehealth flexibilities extended in response to the
pandemic impacted both the Medicare program and beneficiaries. With
that said, do you believe that there are some telehealth regulatory
restrictions that Congress and HHS can work together to address in the
near term that do not require additional data?
About 46 million Americans, nearly 15 percent of the U.S.
population live in rural areas. Those living in rural areas are more
likely to die prematurely and face higher risks for chronic conditions
like heart disease and diabetes. Americans living in rural communities
face 17 percent higher prevalence of diabetes than those living in
urban areas and may have to wait months before needing to travel great
distances to see an endocrinologist to help manage their condition.
This scenario is not uncommon and instead is the reality of rural
Americans that routinely encounter not just a lack of specialty care,
but in my cases, primary care. Digital health tools, including
telehealth and remote monitoring, have the potential to relieve some of
the key healthcare challenges facing rural America.
Sec. Becerra, can you speak to the promise and value of telehealth
and digital health more broadly to rural communities?
Answer. Telehealth is an important tool to improve health equity
and improve access to healthcare. Healthcare should be accessible, no
matter where you live. HHS continues to examine the telehealth
flexibilities developed for the current public health emergency and
determine how we can build on this work to improve health equity and
improve access to healthcare. In addition to looking at which
flexibilities HHS can and should continue administratively, I look
forward to working with Congress to address changes that may need to be
done through legislation.
Throughout the pandemic, telehealth services have filled an urgent
need to maintain access to care while social distancing was necessary.
For example, federally Qualified Health Centers and Rural Health
Clinics were able to be paid by Medicare as distant site telehealth
service providers, which had not been permitted outside of the COVID-19
public health emergency. After the pandemic, HHS will continue to
support telehealth services. HHS is currently reviewing the telehealth
flexibilities developed for the current public health emergency to
determine which can and should continue after the public health
emergency has ended. HHS plans to continue to support telehealth after
the pandemic through resources like the Telehealth.HHS.gov website and
the Telehealth Resource Centers so patients and providers have access
to telehealth technical assistance.
Question. More than 147 million Americans are living with chronic
conditions. It's estimated that 180 million Americans are living with
mental health challenges. According to a 2017 RAND Corporation Study,
90 percent of the US healthcare spend is on chronic conditions, this
includes $327 billion on diabetes and $131 billion for the treatment of
hypertension. These are staggering figures. I believe that technology
has the potential to empower patients, improve access and allow those
Americans already living with these chronic conditions a chance at a
happier, healthier life. Unfortunately, Medicare has been slow to adopt
innovative digital health tools, some of which has been limited by
outdated statutory limitations.
Beyond telehealth, can you speak to the Administration's efforts to
enable Medicare beneficiaries to leverage digital health tools for the
prevention and treatment of disease?
Are their limitations in your ability to expand access to these
valuable resources for those that want to use them within Medicare?
What do you see CMMI's role to be in facilitating the demonstration
and evaluation of virtual care solutions and digital health tools?
Could you discuss how remote patient monitoring is used today in
Medicare and Medicaid today, in addition to telehealth, to help in the
care of those living with chronic conditions like diabetes,
hypertension, asthma or kidney disease?
Remote patient or physiologic monitoring (RPM) has shown great
value in facilitating the management of both acute and chronic
conditions. Using connected devices, individuals can, in real time,
have data shared back with their care team to allow for intervention
and ultimately prevention of more severe health outcomes. While HHS has
begun to allow for the reimbursement of RPM, use of the codes in
Medicare fee-for-service remains rather low.
Do you see value in enabling adoption of additional virtual care
technologies, such as remote monitoring, for Medicare beneficiaries?
From a health equity perspective, what more can be done to make
resources like remote monitoring tools available to all Americans,
especially those living with chronic conditions?
RPM solutions, which for someone with diabetes, may be leveraged
for years, warrants a recurring monthly 20 percent copay. Is there
value in revisiting copay structures for remote monitoring and chronic
care management services?
Answer. Innovation is important to advancing goals in healthcare,
including by learning how to better leverage digital health tools for
the prevention and treatment of disease. Individuals with chronic
disease benefit from access to comprehensive and coordinated care to
manage and treat their chronic conditions and prevent the need for more
costly care. Ensuring access to remote patient monitoring services,
including through evaluating the adequacy of payments, will be
important to beneficiaries who may benefit from these and other virtual
services that allow their physicians to help manage and treat their
health conditions outside of regular office visits. The CMS Innovation
Center is integral to the Administration's efforts to promote high-
value care and encourage healthcare provider innovation, including
virtual and digital health innovation. I look forward to hearing from
Congress on ideas to change coinsurance for Medicare covered services.
______
Questions Submitted by Senator Marco Rubio
Question. I am incredibly concerned about the Biden
Administration's decision to upend decades of bipartisan agreement by
failing to include the Hyde Amendment in the proposed budget.
Does the Administration support taxpayer-funded abortion?
When Congress likely rejects this radical proposal and includes the
Hyde Amendment in future spending bills--will the Administration follow
the law and ensure that Federal Medicaid dollars are not used to
finance abortions?
Answer. The Hyde Amendment disproportionately impacts the growing
number of low- income, women of color who are enrolled in Medicaid, and
is a barrier to expanding access to healthcare. That is why the
President's first budget calls for Congress to remove the restriction
from government spending bills.
The Department of Health & Human Services implements the laws that
Congress passes.
Question. Of additional concern, the NIH announced that it will end
its Ethics Advisory Board for reviewing external research applications
for Federal funding involving the use of human fetal tissue.
Why has the NIH moved to end the Ethics Advisory Board?
What plan does the NIH have in place to provide adequate oversight
and ensure Federal laws are followed?
Answer. NIH's mission is to seek fundamental knowledge about the
nature and behavior of living systems and apply that knowledge to
enhance health, lengthen life, and reduce illness and disability. Under
its broad research mission, and as authorized by the Public Health
Service Act, NIH conducts and funds biomedical research involving the
study, analysis, or use of human fetal tissue for a range of diseases
and conditions. NIH also funds research to develop, demonstrate, and
validate experimental models that are alternatives to the use of human
fetal tissue.
Given the current administration taking a different position on the
merit of this research, the U.S. Department of Health and Human
Services decided to rescind the 2019 decision that all research
applications for NIH grants and contracts proposing the use of human
fetal tissue from elective abortions will be reviewed by an Ethics
Advisory Board. So on April 16, 2021, NIH published an Update on
Changes to NIH Requirements Regarding Proposed Human Fetal Tissue
Research (NOT-OD-21-111),\28\ stating that HHS was reversing its 2019
decision that all research applications for NIH grants and contracts
proposing the use of human fetal tissue from elective abortions will be
reviewed by an Ethics Advisory Board. Accordingly, HHS/NIH will not
convene another NIH Human Fetal Tissue Research Ethics Advisory Board.
Please note that all other requirements described in NOT-OD-19-128 \29\
and updated in NOT-OD-19-137 \30\ for extramural research remain
unchanged. Furthermore, NIH reminded the scientific research community
of expectations to obtain informed consent from the donor for any NIH-
funded research using human fetal tissue, and of continued obligations
to conduct such research only in accord with any applicable Federal,
state, or local laws and regulations, including prohibitions on the
payment of valuable consideration for such tissue.\31\ The same
requirements apply to the NIH intramural research program.
---------------------------------------------------------------------------
\28\ grants.nih.gov/grants/guide/notice-files/NOT-OD-21-111.html.
\29\ grants.nih.gov/grants/guide/notice-files/NOT-OD-19-128.html.
\30\ grants.nih.gov/grants/guide/notice-files/NOT-OD-19-137.html.
\31\ grants.nih.gov/grants/guide/notice-files/not-od-16-033.html.
---------------------------------------------------------------------------
All NIH-supported organizations certify that they will comply with
the NIH Grants Policy Statement,\32\ which summarizes NIH policies
regarding the use of human fetal tissue in research and incorporates
Federal statutory requirements for research with human fetal tissue
(sections 498A and 498B of the PHS Act, 42 U.S.C. 298g-1 and 298g-2).
---------------------------------------------------------------------------
\32\ grants.nih.gov/grants/policy/nihgps/HTML5/introduction.htm.
---------------------------------------------------------------------------
Question. With much of the country finally moving to pre-pandemic
operations, and as Americans are taking flights, riding trains, and
generally living their lives, all without a Federal vaccine
requirement, there is one industry that the CDC continues to treat
differently.
The White House Press Secretary has stated: ``The government is not
now, nor will we be supporting a system that requires Americans
to carry a credential. There will be no Federal vaccinations
database and no Federal mandate requiring everyone to obtain a
single vaccination credential . . . Our interest is very simple
from the Federal Government, which is American's privacy and
rights should be protected so that these systems are not used
against people unfairly,''
Mr. Secretary, if this were true, then the CDC would not be
restricting cruise activities, and would not be putting unfair guidance
in place that essentially requires that a minimum number of cruise
passengers be vaccinated.
If the Biden Administration wants to protect the rights of
Americans and ensure that policies do not discriminate against certain
Americans, then why does the Biden Administration support vaccine
requirements for cruises that discriminate against families with young
children?
Answer. The Conditional Sail Order (CSO) is a phased approach for
the resumption of passenger operations on cruise ships in the U.S. The
timing of these phases depends on cruise ship operators' demonstrated
ability to mitigate COVID-19 risk on board their ships with crew.
Phases can also be adjusted based on lessons learned from the previous
phases.
Under the CSO, cruise ships are not mandated to require cruise
passengers to be vaccinated. CDC recommended that cruise operators
incorporate COVID-19 vaccination strategies to maximally protect
passengers and crew in the maritime environment, seaports, and land-
based communities to further reduce spread of SARS-CoV-2.
CDC is committed to ensuring that cruise ship passenger operations
are conducted in a way that protects crew members, passengers, and port
personnel, particularly with emerging COVID-19 variants of concern.
Question. When does the Biden Administration plan to end
discriminatory policies that make it more difficult for families with
children to go on vacation?
Answer. CDC currently recommends people delay travel until they are
fully vaccinated. Fully vaccinated travelers are less likely to get and
spread COVID-19 and can now travel at low risk to themselves within the
United States. If people are traveling with children who cannot get
vaccinated at this time, CDC recommends choosing safer travel options.
Question. I assume the vaccine mandate is based on science? If so,
can you elaborate on that science?
Answer. Under the CSO, cruise ships are not mandated to require
cruise passengers to be vaccinated. CDC recommended that cruise
operators incorporate COVID-19 vaccination strategies to maximally
protect passengers and crew in the maritime environment, seaports, and
land-based communities to further reduce spread of SARS-CoV-2. COVID-19
vaccinations significantly reduce the risk of severe illness,
hospitalization, and death.
Question. Does this science also apply to airlines, busses, or
trains?
Why or why not?
Answer. Yes, CDC's science applies in all travel settings. CDC's
current domestic and international travel recommendations suggest
people delay travel until they are fully vaccinated. Fully vaccinated
travelers are less likely to get and spread COVID-19 and can travel at
lower risk to themselves.
______
Questions Submitted by Senator Patrick Leahy
Question. The COVID-19 pandemic has disproportionately impacted
rural hospitals and healthcare providers that were already operating on
shrinking margins. The Department has proposed an increase of $71
million for Rural Health programs to ensure access to high-quality care
that caters to the unique needs of rural communities. This funding is
vital to ensure that our rural providers remain viable.
The COVID-19 pandemic has also exposed serious inequities in
healthcare for BIPOC and underserved populations. Rural communities
have been no exception to this issue. How can any funding proposed for
rural health programs help improve outcomes for BIPOC patients in rural
areas?
Answer. This is an important issue; one fifth of rural Americans
are from a racial or ethnic minority group. The Federal Office of Rural
Health Policy has added language in Notices of Funding Opportunity.
Applicants for rural health grants will be expected to address issues
of equity by targeting underserved communities and populations to
ensure program dollars can reach the people most in need to improve
their health outcomes.
While rural Americans face a range of disparities in terms of
mortality, life expectancy and chronic disease burden, those gaps are
even more pronounced for members of racial and ethnic groups who live
in rural communities, and ensuring the data analysis disaggregates race
and ethnicity, when possible, helps monitor progress toward eliminating
disparities. We will continue to do all we can to make sure rural
communities with populations adversely affected by persistent poverty
or inequality are leveraging our grant programs.
SUBCOMMITTEE RECESS
Senator Murray. This committee will next meet in Dirksen
138 Wednesday, June 16 at 10 a.m. for a hearing on the Biden
administration's budget request for the Department of
Education. The hearing is adjourned.
[Whereupon, at 11:48 a.m., Wednesday, June 9, the
subcommittee was recessed, to reconvene at 10 a.m., Wednesday,
June 16.]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2022
----------
WEDNESDAY, JUNE 16, 2021
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10 a.m., in room SD-138, Dirksen
Senate Office Building, Hon. Patty Murray (chairwoman)
presiding.
Present: Senators Murray, Durbin, Reed, Shaheen, Manchin,
Blunt, Moran, Hyde-Smith, and Braun.
DEPARTMENT OF EDUCATION
Office of the Secretary
STATEMENT OF HON. MIGUEL CARDONA, SECRETARY
OPENING STATEMENT OF SENATOR PATTY MURRAY
Senator Murray. Good morning. The Senate Appropriations
Subcommittee on Labor, Health and Human Services, Education and
Related Agencies will please come to order.
Today we are having a hearing on the Biden administration's
fiscal year 2022 budget request for the Department of
Education. Senator Blunt and I will each have an opening
statement. And then I will introduce our witness, Secretary
Cardona. After his testimony, Senators will each have 5 minutes
for a round of questions. And while we are unable to have the
hearing fully open yet to the public or media for in-person
attendance, live video is available on our committee website.
And if you are in need of accommodations, including closed
captioning, you can reach out to the committee or the office of
congressional accessibility services.
Secretary Cardona, after years of proposed budget cuts and
school privatization from your predecessor, this budget would
increase education funding by 40 percent to $103 billion, and
it is a much-needed breath of fresh air. It proposes bold
investments to help our schools and students as they respond to
and recover from this pandemic, and addresses long-standing
inequities in education, which COVID-19 has made even more
damaging.
LOST LEARNING TIME AND DISPARITIES
One of the biggest issues facing our Nation is getting our
students back on track and addressing the lost learning time
that they have experienced. We know students of color, students
with disabilities, students in rural and Tribal communities,
and students from families with low incomes have borne the
brunt of this pandemic.
One study, for example, found the pandemic set students of
color back 3 to 5 months from where they would be in a typical
year, and set white students back 1 to 3 months. We need to
make sure every student, no matter who they are, or where they
live, or how much money they or their family make, can receive
the supports they need to thrive despite this pandemic.
So I am glad this budget takes the task of reckoning with
these inequities seriously, with investments across a range of
programs to help ensure all students can get a quality public
education. It invests $20 billion in a new initiative intended
to reduce disparities in public, elementary, and secondary
education in our country, and proposes to use this funding to
help public schools address a variety of issues, including
inequities in State and local education funding, expanding high
quality preschool programs, and improving outcomes for all of
our students.
INDIVIDUALS WITH DISABILITIES EDUCATION ACT
Of course, improving outcomes for students means we must
also do more to support students with disabilities. This budget
takes an historic step on that front by proposing a $3 billion
increase for the Individuals with Disabilities Education Act.
Over the years, Congress has fallen short of its promise to use
40 percent of the funding to support the education of students
with disabilities through IDEA (Individuals with Disabilities
Education Act).
Currently only 13 percent is provided and struggling States
and districts have been left to fill in the gaps. President
Biden's proposal will help us better keep this promise and help
schools across the country, address the shortage of teachers
for students with disabilities, and provide early intervention
services so students can get the support they need to succeed
as soon as possible.
And when it comes to supporting students' academic, social,
emotional, and mental health needs, this budget proposes a $413
million increase for full-service community schools, an
increase of $120 million for English Language Acquisition
Grants, and a new $1 billion initiative to ensure students have
access to school counselors, nurses, and mental health
professionals.
This is especially critical, given the mental health
challenges students, educators, and school staff have faced
during the pandemic. These challenges will persist well into
the next school year. We need to make investments to support
student and staff wellbeing, and we need to bring in more
counselors, nurses, and psychologists. In Washington State we
only have one school psychologist for every 1,000 students.
This budget will help us tackle inequities in higher education
as well, and significantly expand support for students pursuing
a postsecondary education, including by increasing the maximum
Pell Grant by almost a third.
HIGHER EDUCATION
This is so important. Federal support like Pell Grants
allowed my six brothers, and sisters, and I, to all go to
college. But Pell has gone from covering 75 percent of the
average cost of a 4-year degree at its peak to less than 30
percent today. We have to strengthen and expand Pell. And this
budget is a clear step in the right direction. Ultimately, we
need to do even more to double the maximum Pell award over the
next 6 years, protect Pell from being cut by budget shortfalls,
and expand Pell Grants to more students.
Today, I join colleagues in the House and Senate to
introduce legislation to accomplish all of that. And I hope to
work with you, Secretary Cardona, and my colleagues here in
Congress to get this done. And increased Pell Grants are just
one of several investments, this budget proposes to make higher
education more accessible and affordable for all students,
provides funding to help implement the Bipartisan FAFSA (Free
Application for Federal Student Aid) Simplification Bill I
worked to pass last December.
This will make it easier for all students to apply for
financial aid, including Pell Grants, expand the number of
students eligible for support, and increase financial aid to
students with low incomes. It increases funding for TRIO
programs, which help first-generation college students,
students with disabilities, and students from families with low
incomes to get to and go through college successfully.
It nearly doubles funding for quality campus-based
childcare to support student and parents under the CCAMPIS
(Child Care Access Means Parents in School) Program. And it
provides increased funding for historically under-resourced
colleges and universities, including $345 million, which is a
44 percent increase, in funding for minority serving
institutions, like Historically Black Colleges, and
Universities, and other institutions predominantly serving low-
income students, like community colleges. And finally, this
budget increases funding for the Department's Office for Civil
Rights.
TITLE IX
Between this budget and the public hearings, the Department
started last week on the previous administration's inadequate
Title IX Rule, it is clear we have a President who is focused
on protecting students, no matter their race, ethnicity,
religion, sex, including sexual orientation, and gender
identity, or disability.
I will be watching your work in this space closely, and
encourage the Department to continue its efforts, to hear,
acknowledge and address the stories and concerns of survivors
of sexual assault.
EDUCATION FOR HOMELESS CHILDREN AND YOUTHS
I will say, one area where I would like to see an increased
investment, is funding to support education for children and
youth who are experiencing homelessness. But overall, this
budget is night-and-day different from the previous
administration. I always say a budget is a reflection of your
values. And this budget shows President Biden understands the
money we spend on schools, students, and public education is an
investment in our future. What our Nation accomplishes in the
years ahead will be determined by the opportunities and support
we are able to give children across the country, now.
I look forward to working with the administration and with
my colleagues on this committee to make the investments in
education we need to make so we have a brighter future for our
families.
With that, I will turn it over to Senator Blunt for his
remarks.
STATEMENT OF SENATOR ROY BLUNT
Senator Blunt. Well, thank you, Senator Murray. And welcome
to the hearing, Secretary Cardona. I know this is your first
time to appear before this committee, and I am sure by the end
of the hearing, you will be looking forward to next year when
you get to come back, and the other discussions we will have
between now and then. I am just glad we had a chance to talk,
not only during the confirmation process, but again yesterday,
and look for more opportunities to do that.
Certainly, the last year has been one of the most
challenging years for students, for parents, for school
administrators, for teachers, for everybody in the education
field, including cafeteria workers, and bus drivers who, in a
virtual setting, wound up without a job while everybody else's
jobs became maybe even longer in a day to get ready for the new
challenges of virtual education, where that occurred, and to
try to get back to school, as quickly as they could.
You know, you and I are both first-generation college
graduates, and we have both been classroom teachers, and so I
think because of that, hopefully, we have an understanding of
just how important education is, and what a difference, just a
slight change it points along the way of your trajectory of
where you think your life can take you, can make for the people
we taught, just like we both saw happen with us.
We also understand the critical role education plays in our
society. Our ability to compete around the world, the values
that we transmit from one generation to another, all very
important. I am a proud supporter of many of the programs we
are going to be talking about today, career and technical
education, state grants, IDEA, Title I, the TRIO Programs,
school-based mental health, that you and I talked about
yesterday.
Now I am concerned about the spending level. I just heard
the Chair mentioned the importance of this huge increase of
about 41 percent in spending. I think that increase on top of
the $280 billion in COVID-19 supplemental funding for
education, last year, is a lot of input into the system in a
very short period of time. In fact, last year's spending was
about four times as much as the Department normally receives in
annual appropriations each year. This year the request is
$102.8 billion, which is almost $30 billion, or 41 percent
greater than last year's spending.
It is a lot of money to try to put into the system all at
once. I look forward to hearing your plans and, hopefully, some
of your concerns about how that much new funding going into the
system would go in, in the best possible way. As a former
university president, I am particularly concerned about the
proposal to make community college tuition free for all
students. As, you know, my view is if you want to make a
college education really expensive, make it free, but we will
talk about that.
We will talk about what we are doing now to make it
possible for people to go to college and what you are proposing
in terms of making those first 2 years free at community
colleges. I would point out that in the average community
college in America, if you qualify for the full Pell Grant, you
have more money in that grant than books, fees, and tuition. I
think the average Pell Grant recipient was $3,946, the average
tuition and fees at community colleges was $3,700. I think
there may be other ways to make it possible for more people to
go to community college, and all other schools without cost.
But we are going to talk about that today, and as we move
forward with this budget.
Many States across the country already have programs that
make up the difference, and at a community college in Missouri
the A+ scholarship pays the community college tuition for
eligible students for up to 2 years. I do think those colleges
play an incredibly important role in the country. Both as an
access point for education, but also as a way to get people
ready for jobs that are available, or could be available, in a
specific community.
I am concerned that free community college for everybody
unfairly subsidizes higher-income students. And if it is
community college only, it creates an incentive for students to
attend schools that may not be the best fit for them. Through
the Pell Grant limited taxpayer dollars have targeted students
in the most need. It maintains the ability of students to Pell
Grant, and most of our other programs, to pick institutions
that best meet their individual needs.
Since this committee worked to reinstate year-round Pell
Grants, with Senator Murray and I working hard to lead on that
effort, students have the flexibility to accelerate their post-
secondary studies and complete their programs more quickly.
I am pleased to see that the budget does not include
widespread loan forgiveness. However, the Department has not
outlined a plan at the same time for borrowers to get back into
the repayment process. Federal student loan borrowers have gone
for over a year without being required to make a payment on
their loans. And I think it is important that the Department
begins communicating to those borrowers early and often to
ensure that all borrowers understand their responsibilities,
and their repayment options when a payment or a loan comes due
October 1 of this year. I don't see any discussion about that
in the comments you are making today, and something I would
like to see more thought given to.
I am also concerned that the Department has not announced
how long the student loan servicing will be handled moving
forward, once the legacy servicing contracts end later this
year. We have spent a lot of time in this committee looking at
past proposals on changing that system. As you and I discussed
yesterday, I look forward to hearing your thoughts as to how
that system moved forward.
We both support increased educational opportunities in
every State, such as Title I and IDEA. It is my goal to find
ways we can work together. This budget proposes a 10 percent
increase, or $120 million in discretionary funding for career
and technical education, teamed with $1 billion in mandatory
funding for a New Career Pathways Program. I do think it is
critically important we provide students with meaningful
information about the jobs that are out there with the work-
based learning opportunities and exposure to different career
paths early in high school.
We have been talking about that for some time. There is a
lost decade for so many people from the time they graduate
until the time they really settle in, to the career that
provides the most promise and the most satisfaction for them.
So I look forward to working together on this. I know we
are going to have a number of questions and concerns about this
budget, but it is a critically important part of how people
move forward in our country, giving them those opportunities
and the information they need. And I look forward to working
with you to find the appropriate balance between fiscal
responsibility and meaningful investment that supports access
to quality education for all students.
Thank you, Chair.
[The statement follows:]
Prepared Statement of Senator Roy Blunt
Good morning. Thank you, Chair Murray. And thank you, Secretary
Cardona, for appearing before the Subcommittee today to discuss the
Department of Education's FY2022 budget request.
This has been a long and challenging year for all Americans, but it
has been particularly difficult for students, parents, teachers, school
administrators, and all those in the education field. You and I are
both first generation college graduates and classroom teachers, we know
how much education can change the trajectory of a person's life,
because we saw it in our own lives and in the lives of the people we
taught. We also understand the critical role education plays in our
society and its impact on our nation's ability to compete in a global
economy.
Because of that, I am proud to support key programs that the
Department of Education administers such as career and technical
education state grants, IDEA, and Title I, Part A. However, I am
concerned with the unprecedented level of spending proposed in this
budget request, particularly at a time when Congress has already
provided almost $280 billion in COVID-19 supplemental funding for
education in the last year. For reference, that is about four times as
much as the Department receives in annual appropriations each year.
The FY2022 budget request for the Department of Education is $102.8
billion, which is $29.8 billion, or 41 percent, more than FY2021.
Future generations can't afford this budget. It also invests the
majority of new funding in new programs--and the budget provides few
details on how these programs will work and who will benefit.
As a former university president, I am particularly concerned about
the proposal to make community college tuition ``free'' for all
students. As the saying goes, if you think college is expensive now,
wait until you see what it costs when it's free.
First, for most low-income students who receive a Pell Grant,
community college tuition is already free. Last school year, the
average Pell Grant recipient at a community college received $3,946,
while the average tuition and fees at these schools were only $3,700.
Second, many states across the country already have programs to
make up the difference between a student's Pell Grant and the cost of
community college if there is one. In Missouri, the A+ Scholarship pays
the community college tuition for an eligible student for up to two
years.
Finally, while community colleges play a crucial role in our
diverse higher education system in America, they may not be the best
choice for every student.
Rather than subsidizing higher income students and incentivizing
students to attend schools that may not be the best fit for them, we
should instead focus our investments in programs that make a student's
choice in college affordable. And the best way to do so is through the
Pell Grant program and other programs like the GI bill, work study and
SEOG.
Through the Pell Grant program, limited taxpayer dollars are
targeted toward students most in need. It maintains the ability of
students to pick the institutions that best meets their individual
needs. And since this Subcommittee reinstated year-round Pell Grants in
FY2017, students have the flexibility to accelerate their postsecondary
studies and complete their programs more quickly. This Subcommittee has
boosted the maximum Pell Grant award for the past four years, and I
hope we can do so again this year.
While I am pleased to see that the budget request does not include
widespread loan forgiveness, I am concerned that the Administration has
not outlined a plan to transition borrowers back into repayment when
the student loan pause ends this fall. Federal student loan borrowers
have gone over a year without making a payment on their loans.
It is absolutely imperative that the Department begins
communicating with borrowers early and often to ensure that all
borrowers understand their responsibilities and their repayment options
when a payment or loan come due on October 1, 2021.
As borrowers begin to repay their loans after such a long pause,
student loan servicing will be more important than ever. However, I am
concerned that the Department has not announced how student loan
servicing will be handled moving forward once legacy servicing
contracts end later this year and early next year. This Subcommittee
has worked closely with the Department over the past several years as
it continues to reform and modernize the Federal student loan servicing
system, and I hope that will continue.
Mr. Secretary, while there are issues on which we disagree, we have
many shared priorities that are reflected in the budget request. I know
we both share a strong desire to fund programs that are proven and
benefit all students, and I know we both support increased educational
opportunities in every state, such as Title I and IDEA. It is my goal
for us to work together on many of these and other important issues.
In particular, the budget proposes a 10 percent increase, or $128
million, in discretionary funding for career and technical education,
teamed with $1 billion in mandatory funding for a new career pathways
program. While this Subcommittee will only consider the discretionary
request, I am interested in your ideas for how this and other efforts
could improve educational opportunities for students beginning in high
school, or earlier, to pursue the full-range of post-secondary college
and career opportunities.
Providing students meaningful work-based learning opportunities and
exposure to different career paths early in high school, or even middle
school, can help them identify interests that lead to well-paying jobs
and careers. Too often individuals only find opportunities through
apprenticeships or high-quality credential programs later in life, in
their late twenties or thirties.
I call this the Lost Decade and have provided the Department $10
million each of the past two years to work toward addressing these
issues. I think giving more students access to these opportunities
earlier on is an area of interest for us both, and I hope it is
something we can work on together.
Mr. Secretary, I look forward to working with you this year to find
the appropriate balance between fiscal responsibility and meaningful
investments that support access to quality education for all students.
Thank you again for being here today.
Senator Murray. Thank you, Senator Blunt.
Our witness is today, is Miguel Cardona, Secretary of the
Department of Education. Secretary Cardona, thank you for
joining us today. And I am so glad you could be here. I look
forward to your testimony, and you may begin now.
SUMMARY STATEMENT OF HON. MIGUEL CARDONA
Secretary Cardona. Thank you. Good morning, Chairwoman
Murray, Ranking Member Blunt, and distinguished members of the
subcommittee.
I recently attended an International Thespian Induction
ceremony at a high school where students were being inducted
for their commitment to theater after this long year. My
daughter was one of those students. I can tell you, it was the
first time we came together as a school community in over a
year. So the room was filled with a lot of emotion.
FULFILLING OUR ROLES TO IMPROVE THE EDUCATION SYSTEM
One thing caught my eye, there was a banner hanging that
had a quote from the renowned poet, Alexander Pope, and the
banner read, ``Act well your part, there all the honour lies.''
In other words, do your part, and that is where you will find
the honor.
I come to you today representing the Department of
Education, as we boldly do our part to serve the students
across the country. That is our responsibility and our
privilege. And that is where our collective honor lies.
To that end, I am proud to testify today about President
Biden's fiscal year 2022 budget request for the Department of
Education, because it makes good on the President's campaign
commitment to invest in education. It also begins to address
the significant inequities that students, primarily students of
color, confront every day in schools, in pursuit of higher
education, and career technical education. I want to thank
members of the subcommittee and your staff who have helped
ensure the passage of the American Rescue Plan, bringing vital
resources to our schools and colleges across the country. The
American Rescue Plan funds will ensure that school buildings
reopen for full-time in-person instruction safely and quickly.
EDUCATION AS AN EQUALIZER
I come to you today with a great sense of urgency about the
work we have to do. Generations of inequity have left far too
many students without equitable access to high-quality,
inclusive learning opportunities, including in our rural
communities. Education can be the great equalizer like it was
for me and for many of you, but we have to prioritize,
replicate, and invest in what works for all students. Not just
some.
We must do more to level the playing field, including
providing a strong foundation from birth, improving diversity
among the teacher workforce, creating learning pathways that
work for all students. To that end, the budget proposal calls
on Congress to invest nearly $103 billion in the Department of
Education's programs, a 41 percent increase over the fiscal
year 2021 appropriation to support students' success.
OVERVIEW OF THE BUDGET REQUEST
The fiscal year 2022 request also makes a meaningful down
payment toward the Biden-Harris administration's goal of
reversing inequities. That is what is at stake here, reversing
inequities. The centerpiece is a proposal for a new $20 billion
Title I equity grants program that would address inequities and
disparities between under-resourced schools and their wealthier
counterparts.
It would support competitive compensation for teachers and
Title I schools, expand access to pre-kindergarten, and
increase preparation for, access to, and success in rigorous
coursework. Our requests would put the Nation on a path to
double the number of school counselors, nurses, and mental
health professionals in our schools, and significantly expand
support for community schools to help increase the availability
of wraparound service services to students and families in
underserved schools and communities.
The pandemic reinforced the need for this. We also think it
is past time for the Federal Government to make good on its
commitment to students with disabilities, and their families,
and the request makes a significant move toward full funding of
IDEA, proposing a 20 percent increase for IDEA State grants of
$2.6 billion.
Turning to higher education, an area that needs immediate
attention. Our budget proposal begins the Biden-Harris
administration's critical work to increase access and
affordability for students. The budget proposal coupled with
increased proposals--proposed in the American Families Plan
would be the largest increase to Pell Grant ever, helping
millions of students and families pursue their goals.
Importantly, our proposal would ensure that Dreamers may also
receive Pell Grants if they meet current eligibility
requirements.
The fiscal year 2022 request paints a bold picture for the
future of our institutional and student support programs. The
budget increases institutional capacity and student supports at
minority-serving institutions, with additional funding for
HBCUs (Historically Black Colleges and Universities), Hispanic-
Serving Institutions, Asian-American, and Native-American
Pacific Islander-serving Institutions, and Tribally Controlled
Colleges and Universities, as well as our beloved TRIO and GEAR
UP programs to help ensure underserved students succeed and
graduate from college.
Finally, we would prioritize efforts to enforce civil
rights laws related to education through a 10 percent increase
for the Office for Civil Rights, to protect students and
advance equity and educational opportunity, and delivery in
preschool through college. This is a fundamental right we are
committed to for all students.
Working together with stakeholders, including students and
educators, we can and will heal, learn, and grow together,
during this challenging time. I am committed to working
collaboratively with each of you to strengthen our schools, and
campuses, and to help improve opportunities, pathways, and
outcomes for students across the country, including students in
our rural communities.
Thank you. And I look forward to answering any questions
you may have.
[The statement follows:]
Prepared Statement of Hon. Miguel Cardona
Good morning Chairwoman Murray and Ranking Member Blunt.
I am pleased to join you today, and I am proud to testify on behalf
of President Biden's fiscal year 2022 Budget Request for the Department
of Education. The full fiscal year 2022 Budget Request, which was
released a little over two weeks ago, makes good on President
Biden's campaign commitment to reverse years of underinvestment in
Federal education programs and would begin to address the significant
inequities that millions of students--primarily students of color--and
teachers confront every day in underserved schools across America.
These inequities in opportunity and access continue to be experienced
by students pursuing higher education and career and technical
education credentials as well.
american rescue plan act
Before I begin, I want to thank the Members of the Subcommittee--
and your staff--who helped carry the American Rescue Plan Act to the
finish line. I can tell you from immediate experience that the ARP
funds will make all the difference in ensuring that schools re-open for
full-time, in-person instruction as safely and soon as possible. In
addition, ARP funds will enable schools to address the mental health,
social, and emotional needs of students that the pandemic has laid
bare, and to fully recover from the massive impact of lost
instructional time on student achievement during the pandemic.
The plans to reopen are bold--and will require coordination among
key stakeholders at the Federal, State, and local levels. But they
match the urgency the challenges before us demand. It's important to
remember that once we fully reopen schools, we still have work to do.
Our job will not be done. Generations of inequity have left far too
many students without equitable access to high-quality, inclusive
learning opportunities. Education can be the great equalizer--it was
for me--if we prioritize, replicate, and invest in what works for all
students, not just some.
We must do more to level the playing field, including providing a
strong foundation from birth, improving diversity among the teacher
workforce, and creating learning pathways that work for all students.
To that end, the fiscal year 2022 budget proposal for the Department of
Education provides strong investments in key areas to ensure students
of all ages have what they need to succeed.
department of education funding levels
The President's fiscal year 2022 request calls for a significant
and long-overdue increase in Federal support for education from birth
through college and career. The proposed discretionary request of $103
billion for Department of Education programs, an increase of almost $30
billion over the fiscal year 2021 enacted level, would be complemented
by additional mandatory investments under the American Jobs Plan and
the American Families Plan. We understand that some have raised
questions about the unprecedented increase in Federal education funding
proposed by President Biden, particularly coming on top of emergency
appropriations over the past year to address the impact of the COVID-19
pandemic on our schools. However, it's important to recognize that
these bold proposals follow a decade of virtually no funding growth in
real terms for Department programs, a significant under-investment in
light of the rising needs of students and families.
The $73.5 billion that Congress appropriated for the Department for
the current fiscal year, fiscal year 2021, is about 8 percent more than
the fiscal year 2011 total of $68.3 billion. Title I funding did a
little better, up 10 percent, or 1 percent a year, over the same period
of time. The total Federal investment in elementary and secondary
education grew at the same rate--just 1 percent annually over the past
10 years--not even keeping up with inflation.
funding inequities in state and local education systems
This underinvestment in K-12 education matters because of the
dramatic and longstanding inequities in State and local education
funding systems, which despite more than half a century of litigation
and reform, too often continue to provide significantly less funding
for high-poverty districts and schools, which are more likely to serve
students of color, resulting in a disproportionate impact on these
students. Reversing these funding inequities, as well as immediately
addressing the negative impact of those inequities in service of
students, are critical goals of the Biden-Harris Administration's
racial equity agenda, and the President's fiscal year 2022 request for
the Department of Education would make a meaningful down payment toward
these goals. Addressing these inequities are critical to our nation's
future. Our country and our economy will be stronger when every child
is prepared to succeed in tomorrow's economy, regardless of race, zip
code, their family's income, or disability.
investment in title i grants to local educational agencies
The centerpiece of that request is $20 billion for a new Title I
Equity Grants program--part of the President's commitment to
dramatically increase funding for Title I schools--that would help
address long-standing funding disparities between under-resourced
school districts and their wealthier counterparts; ensure teachers in
Title I schools are paid competitively; support expanded access to
preschool; and increase preparation for, access to, and success in the
rigorous coursework needed to prepare for postsecondary education and
high-paying, in-demand careers. This proposal will further the goals of
Title I as outlined by President Johnson in partnership with Congress
back in 1965 as part of the War on Poverty, to help ensure that all
students--especially students from low-income backgrounds and students
of color in underserved communities--receive the high-quality education
they need to thrive and achieve their dreams.
investment in improving students' physical and mental health
Long before the COVID-19 pandemic there was increasing evidence
that the conditions of poverty--especially concentrated poverty--take a
tragic toll on the physical and mental health of students. This
warrants significant investments in mitigating the impact of this toll
in order to improve student outcomes. Congress recognized this problem,
in part, through the creation and rapid increase in funding for the
Title IV-A Student Support and Academic Enrichment program. Our request
would build on these efforts through a $1 billion investment for a new
School-Based Health Professionals program to support the mental health
needs of our students by increasing the number of counselors, nurses,
and mental health professionals in our schools, and building the
pipeline for these critical staff, with an emphasis on underserved
schools.
community-based programs
In addition, the President's request would help increase the
availability of a broad range of wrap-around services to students and
families in underserved schools and communities through a significant
expansion of the Full-Service Community Schools program, from $30
million in fiscal year 2021 to $443 million in fiscal year 2022. This
program recognizes the role of schools as the centers of our
communities and neighborhoods, and funds efforts to identify and
integrate the wide range of community-based resources needed to support
students and their families, expand learning opportunities for students
and parents alike, support collaborative leadership and practices, and
promote the family and community engagement that can help ensure
student success. The request would support implementation of the
community schools model at roughly 800 additional schools serving up to
2.4 million students, family members, and community members.
Our request also would help strengthen communities by fostering
diverse schools through renewed efforts to improve school racial and
socioeconomic diversity. We would provide $100 million for a new
Fostering Diverse Schools program that would help communities develop
and implement strategies that will build more racially and
socioeconomically diverse schools. Research suggests that diverse
learning environments benefit all students and can improve student
achievement, serve as engines of social and economic mobility, and
promote school improvement. Our proposal also would build evidence
around effective practices for addressing the growing concern that our
Nation's schools are becoming less diverse and more segregated each
year.
support for special education
We also think it is past time for the Federal Government to make
good on its commitment to students with disabilities and their
families, as expressed in the Individuals with Disabilities Education
Act. The President's request makes a significant move toward full
funding of the IDEA with a $2.6 billion, or 20 percent, increase for
IDEA Part B Grants to States above the regular fiscal year 2021
appropriation, for a total of $15.5 billion. Notably, this increase
would raise the Federal share of the excess cost of serving students
with disabilities for the first time in 8 years-demonstrating that IDEA
has been yet another casualty of the Federal underinvestment in
education over the past 10 years.
In addition, we would increase funding for the IDEA Part C Grants
for the Infants and Families program by more than 50 percent, or $250
million above the regular fiscal year 2021 appropriation level, for a
total of $732 million to expand access to early intervention services
for infants and toddlers with disabilities. We would pair this
increased funding with reforms to strengthen the Part C program,
particularly for children who have been historically underrepresented
in the program, including children of color.
The President's Request would also boost the Preschool Grants
program by $105 million over the 2021 appropriation, to aid in the
provision of special education and related services for children with
disabilities aged 3 through 5.
teacher training and support
The Title I Equity Grants proposal is just one demonstration of
President Biden's strong commitment to teachers. Other key investments,
split between discretionary and mandatory American Families Plan
funding, include $412 million ($132 million in discretionary funding
and an additional $280 in mandatory authority for fiscal year 2022) for
Teacher Quality Partnerships to address teaching shortages, improve
training and supports for teachers, and boost teacher diversity,
particularly through investment in teacher residencies and Grow Your
Own programs; $340 million ($250 million in discretionary funding and
an additional $90 million in mandatory authority for fiscal year 2022)
for Special Education Personnel Preparation to ensure that there are
adequate numbers of personnel with the skills and knowledge necessary
to help children with disabilities succeed educationally; and $60
million ($20 million in discretionary funding and an additional $40 in
mandatory authority for fiscal year 2022) to fund for the first time
the Hawkins Centers of Excellence program designed to increase the
quality and number of new teachers of color. In addition, the American
Families Plan would make a one-time mandatory investment of $1.6
billion to support additional certifications at no cost for more than
100,000 educators in high-demand areas like special education,
bilingual education, career and technical education, and science,
technology, engineering, and mathematics. We are also requesting,
through the American Families Plan, $200 million in mandatory authority
for a new Expanding Opportunities for Teacher Leadership and
Development program to support opportunities for experienced and
effective teachers to lead and have a greater impact on their school
community while remaining in the classroom (and be compensated for
additional responsibilities) through such activities as high-quality
teacher mentorship programs and job-embedded coaching. Lastly, the
American Families Plan would double TEACH Grants from $4,000 to $8,000
for future teachers while earning their degrees.
improving career pathways
The President's Request also recognizes that a skilled workforce is
critical for both strong communities and a strong economy by proposing
to make targeted investments that would help build the capacity of our
workforce development system. These investments include an increase of
$108 million in Career and Technical Education National Programs to
support an innovation grants initiative focused on youth work-based
learning and industry credential attainment, along with a $25 million
increase under Adult Education National Leadership Activities to expand
college bridge programs for low-skilled adults without a high school
degree. In addition, the American Jobs Plan would provide $1 billion in
mandatory funding in fiscal year 2022 ($10 billion total over 10 years)
to expand career pathways for underserved middle and high school
students that include partnerships with employers, community colleges
and other partners and allow students to earn credentials or college
credit while still in high school; and also would invest $100 million
annually over the next 10 years to help connect job-seeking adults to
employment opportunities by focusing on foundational skills and
embedded career services.
postsecondary education investments
Turning to higher education, our budget proposal would make
postsecondary education more affordable for students from low-income
households through a $400 increase to the maximum Pell Grant. In
combination with the $1,475 increase to the maximum Pell Grant proposed
in the American Families Plan, the increase in 2022 would be the
largest increase to the Pell Grant ever. This historic increase is just
a first step in a more comprehensive proposal to double the grant.
Importantly, our proposal also would ensure that postsecondary students
who are DACA recipients may receive Pell Grants and other federal aid
if they meet current eligibility requirements.
Through the American Families Plan, our budget proposal would
provide two years of free community college to first-time students and
those wishing to reskill. It would also make college more affordable
for low- and middle-income students at four-year Historically Black
Colleges and Universities (HBCUs), Tribal Colleges and Universities
(TCUs), and Minority Serving Institutions (MSIs) such as Hispanic-
Serving Institutions (HSIs) and Asian American and Native American
Pacific Islander-Serving Institutions (AANAPISIs).
The fiscal year 2022 request also would increase institutional
capacity and student supports at HBCUs, TCUs, and MSIs, and other
under-resourced institutions, such as community colleges. The
discretionary request includes more than $600 million in additional
funding for institutional supports programs and programs like TRIO and
GEAR UP, to help ensure underserved students succeed in and graduate
from college. The American Families Plan also provides historic
mandatory investments over ten years in college access and success,
including $46 billion for HBCUs, TCUs, and MSIs, and $62 billion for a
new Completion Grants program that would make formula grants to States
to support the use of evidence-based strategies to strengthen
completion and retention rates at institutions that serve students from
our most disadvantaged communities like community colleges.
school infrastructure
Too many students attend schools and child care centers that are
run-down, unsafe, and pose health risks. These conditions are dangerous
for our kids and exist disproportionately in schools with a high
percentage of low-income students and students of color. We can't close
the opportunity gap if low-income kids go to schools in buildings that
undermine health and safety, while wealthier students get access to
safe buildings with labs and technology that prepare them for the jobs
of the future. Accordingly, the American Jobs Plan would provide $10
billion in mandatory funding in 2022, and $50 billion over five years,
for grants to upgrade existing school facilities and build new public
elementary and secondary schools. Outside of the Department of
Education, funding would leverage an additional $50 billion in
investments in school infrastructure through bonds. The American Jobs
Plan would also provide $2.4 billion in mandatory funding in 2022, and
$12 billion over five years, for grants to invest in community college
facilities and technology in order to help protect the health and
safety of students and faculty, address education deserts (particularly
for rural communities), grow local economies, improve energy efficiency
and resilience, and narrow funding inequities.
student aid administration
In addition to making college more affordable, our budget proposal
will improve the services we provide students and families to help them
pay for college. We are requesting $2.1 billion to administer the
Federal student aid programs in fiscal year 2022, an increase of $200
million over the fiscal year 2021 appropriation. The requested funds
are necessary to implement the FAFSA(r) Simplification Act and FUTURE
Act, which together will greatly ease the process of applying for
student aid and accessing affordable, income-driven repayment options;
provide high-quality loan servicing to more than 40 million student
loan borrowers; and protect the personally identifiable information of
around 75 million students and parents.
enforcement of civil rights laws
Finally, we would prioritize efforts to enforce the Nation's civil
rights laws, as they relate to education, through a 10 percent increase
for the Office for Civil Rights to protect students, providing a total
of $144 million to advance equity in educational opportunity and
delivery at Pre-K through 12 schools and at institutions of higher
education.
closing remarks
Thank you again for this opportunity to share more about the
President's plan to invest in students of all ages and the institutions
that serve them. I look forward to hearing your reactions to this
historic budget request, and to learning more about your individual
interests and priorities related to Department of Education programs
and activities. I am committed to working collaboratively with each of
you, to the greatest extent possible, to help improve educational
opportunities and outcomes for all students.
Thank you, and I will do my best to respond to any questions you
may have.
RESOURCE ALLOCATION
Senator Murray. Thank you so much, Mr. Secretary. We will
now begin around a 5-minute questions of our witness, and I ask
our colleagues to, please, keep track of your clock. Stay
within those 5 minutes.
Mr. Secretary, the President's budget calls for major
investments in our Nation's public schools, acknowledging the
significant resource disparities between schools serving more
students from families with low incomes and their wealthier
peers. These resource discrepancies contribute to the
achievement gap between students of color who represent more
than half of our students served in Title I schools and white
students. One of the key provisions we included in the
Reauthorization of the Elementary and Secondary Education Act,
is a requirement to review the resource inequities in schools
which have been identified for support and improvement.
And we also included a requirement for per pupil
expenditure reporting for all States and school districts in
the Nation, a requirement that still has not been fully
implemented years after we passed the law. I believe that
combination of additional Federal education investments,
accurate and timely reporting, and thoughtful review of how all
education funds are being allocated and used in schools needing
additional support would improve the quality of education
services for all of our students and families.
I know the pandemic has likely impacted the implementation
of these resource allocation reviews, but can you share your
plans for supporting and monitoring State and local agencies
conducting these reviews, as well as your plans for ensuring
States and school districts do comply with the SEA's (State
Educational Agencies) fiscal equity reporting requirements?
Secretary Cardona. Thank you, Senator Murray. And you start
with an issue that is critically important that we must address
together. The opportunity gaps and achievement disparities and
outcomes are significant, so much so that I have been an
educator for over 20 years, it has almost become normalized.
And we have an opportunity here to address it, with the budget
proposal, and the American Families Plan, there is a
transformational opportunity for our country, to not only
recover from the pandemic, but to be better than we ever were
before in education.
And I look forward to ensuring that every penny that is
allocated is used to support our students in a way that is
equitable. You know, we talk a lot about education being the
great equalizer, well, this budget proposes strategies to get
there. And it is important for me to make sure that while the
resources are there, we have equal amounts of accountability to
make sure that the funds are being used for what they were
intended.
So, absolutely, to me, the work that we do at the agency to
ensure that the funds are being used for what they were
intended for is critically as important as providing resources.
We can't get to equalizing the playing field if the resources
are not being used where they are supposed to.
So I, and the team at the Department of Education, will be
very vigilant, especially with this new American Rescue Plan,
and the funding that has been provided over the last year. We
are going to be vigilant to make sure that the funds are being
used for what they are intended to be used for. And I will add
that as we rolled out the American Rescue Plan, we required
States to provide transparent reports on how they were going to
use the money, and engage stakeholders, so they are a part of
the process early and ensure that equity is at the heart of the
plan.
I envision this being something that is going to help lift
our students. And I look forward to working with you and others
to make sure it happens.
INVESTMENTS TO SUPPORT HIGHER EDUCATION
Senator Murray. Okay. Thank you. And on higher Ed, the
pandemic really exacerbated, as we know, the financial
challenges a lot of our students face pursuing a post-secondary
education. Congress, as you know, responded by providing
significant relief to students and borrowers, including
flexible funding to address students' basic needs during this
pandemic. But as our country begins to recover from this
pandemic, many of the financial strains that are facing
students who are low-income, students of color, student
parents, and first-generation students are really out there for
them.
This is not just the cost of tuition and fees I am talking
about, but housing, food, childcare, unexpected bills that can
quickly derail a student's plans. And as we turn this corner on
COVID, we should redouble our efforts to help all students
pursuing a post-secondary education. And this budget I think is
a positive step in that direction. But can you speak for a
moment about the increases for Pell Grants, and childcare, for
students, parents, TRIO, why those investments are so critical
right now?
Secretary Cardona. Thank you, Senator. We recognize now
that if we don't act with urgency, we are going to lose many of
our students who are thinking about higher education as an
opportunity to continue their growth. The increase in Pell
Grants, which is significant under the American Families Plan,
$1,400, and $400 increase here in this budget show the
commitment that the President has toward ensuring equitable
access to higher education for our students.
And we recognize that that, with other supports, are going
to allow for our students to continue to engage in college,
free community college for students, talk about giving an
opportunity to students who might not even think of higher
education, because it is too far off, or the fear of being in
debt for the rest of their lives. With that said, the pause on
loan repayment has provided--saved over $5 billion a month for
over 41 million borrowers. So we know how critically important
that is. It has covered 1.1 million borrowers in the process,
but programs like the Pell increase provide access to college
for many more students. And we were confident with support of
programs like that, and programs like TRIO, more and more
students will look at higher education as an option for
themselves.
Senator Murray. Okay. Thank you very much.
Senator Blunt.
Senator Blunt. Thank you, Chairman.
FREE COMMUNITY COLLEGE
Secretary, let's talk a little about the first 2 years of
college education being free, or at least if you choose to go
to a community college. I am much more inclined to be receptive
to your arguments about increasing the Pell Grant, increasing
even the level of maybe whether you qualify for that maximum
Pell sooner. What are you thinking about in terms of 2 years of
free community college education?
I am a big supporter of the community college system, every
community college in my State, I believe, understands that, but
I don't quite understand, one, why we want to make community
college free for everybody regardless of need. And then my
second question is going to be: Why just community colleges?
But how do you expect this plan to work? And would all students
who choose the community college have no cost of going to that
college?
Secretary Cardona. Thank you, Senator. I recognize that
there are many States that are doing amazing work providing
access to higher education institutions. I was in Michigan
recently, and I saw amazing efforts there to make college
affordable and accessible to students in Michigan. But this
plan would allow 5.5 million students to have access to higher
education who might not have had it previously.
And we know that not only is it a benefit for these
students, but it is a benefit for their families, their
community, and there is an economic benefit. Graduates of 2-
year colleges, on average, earn 21 percent more than students
with a high school diploma. We know that the skills that are
needed in the workforce today are skills that would require
some level of training.
So with good coordination, our free community colleges
connecting with our high schools, connecting with the workforce
and 4-year colleges, which stand to gain because there is going
to be a wider net of students seeking higher education. We do
feel that this is a step forward for the country.
Senator Blunt. Good. I don't disagree with any of those
thoughts, except your point that there would be, I think you
said 5 million students that would not have access to community
college, otherwise. What about all the students that could go
to community college, otherwise, that we are--are we now paying
that tuition as well?
Secretary Cardona. Many of those students are benefiting
from supports now. What we are doing is leveling.
Senator Blunt. No, no. That is not what I am asking. What I
am asking is if any student at any income level wants to go to
community college, can they go for free under this program?
Secretary Cardona. Yes, it would be accessible to all who
want to study in a community college.
EXPANDING FREE COLLEGE PROPOSAL TO ALL ACCREDITED INSTITUTIONS
Senator Blunt. So why would--so let's go to a second
question. Why would you focus that first 2 years on a community
college when students might want--that even qualify for, for
instance, the Pell Grant now, they can take that Pell Grant
money and go to any college, any accredited institution, public
or private, they want to, and many of those institutions now
with fully qualified Pell students, figure out how there is no
other costs beyond Pell. Why would you not allow them to
continue to have that same ability to go free to those schools
as well, if they are students in real economic need?
Secretary Cardona. Under this proposal, students will still
have the choice to attend the college that they would like,
benefiting from Pell Group programs if they are eligible. So it
does not limit options. If anything it provides more options,
and provides more opportunity for students who might not have
considered higher education an option for them due to the
costs.
Senator Blunt. What about, generally, to continue this
discussion, we should have free first 2 years of college, or
free college for everybody, but that almost always talks about
a college in a public school setting, as opposed to an
accredited school setting. I think one of the real strengths of
the American higher education system since World War II has
been virtually all of our programs, whether they were the GI
benefit, or Pell Grants, or any other Federal Government
program, you had the ability to use that at any accredited,
post-secondary institution.
What is your view on that? As we continue to discuss how
access to various levels of grants and fundings public--versus
both public and private competing with each other after high
school?
Secretary Cardona. Thank you, Senator. You know, I look
forward to continuing conversations with you and others to find
the right pathway. What we want to do is provide access to
higher education for students across the country; we know that
access to higher education affords students the opportunities
to better options in life, higher earning potential. And that
is good, not only for the student, but for the community and
the economy, as I said earlier. So I am a big proponent of
providing options for students who want to pursue different
careers, or different educational institution based on their
choice. And I would be in support of exploring options to make
sure that that is accessible under this plan.
Senator Blunt. Well, the current system, as you know,
creates lots of options to accredited institutions. I hope that
continues to be the case, and certainly something you and I
will continue to talk about. Thank you, Secretary.
Secretary Cardona. Thank you.
Senator Blunt. Thank you, Chair.
Senator Murray. Senator Shaheen.
Senator Shaheen. Thank you, Madam Chairwoman.
ACCESS TO AND USE OF COVID RELIEF FUNDS
Mr. Secretary, we are delighted to have you here today. I
want to start with a challenge that we are having in New
Hampshire. As you know, Congress has provided nearly $200
billion for emergency relief for elementary and secondary
schools as a result of the COVID pandemic. This funding was
intended to assist schools during this emergency, and Congress
was very clear when we passed that legislation, that the intent
of these funds is to be--allow them to be at the school's
discretion to meet a wide variety of local needs, including for
construction projects, such as HVAC (Heating, Ventilation, and
Air Conditioning) repairs and improvements.
I am very concerned about the delays that many New
Hampshire schools have experienced when trying to access this
relief funding. And I have been troubled by the Department's
delay in issuing clear implementation guidance that regards
regulatory requirements on States and school districts. Now I
appreciate the guidance that was just provided to--by the
Department to New Hampshire yesterday.
I hope it resolves some of this uncertainty, but there are
still questions that schools have, and in order for them to
benefit from this money, we have a limited time for
construction during the summer, and so it would be really
important to have the Department be very clear on the use of
these funds. So can you talk a little bit about how the
Department is working to allow expeditious access to the funds
that have been approved and appropriated by Congress?
Secretary Cardona. Thank you, Senator. You are absolutely
right. The importance of being expedient in the use of funds to
get them into the schools, to provide the resources that are
needed, to get the students what they need to be in the
classroom quickly and as safely as possible. And with the
distribution of funds, we recognize that different parts of the
country have different needs. I was in Philadelphia recently,
and I learned how the ventilation issues in those schools
prevented students from coming in at the same rate as
communities that had schools that were a bit newer and had
better ventilation. So in that particular area, the issue was
ventilation.
So what we want to do is balance flexibility around how the
funds are used with ensuring that the funds are being used to
safely reopen schools, and address inequities that were
exacerbated during the pandemic. And by the strategies that we
are taking is becoming accessible, and making sure we are
working with States on their individual needs, and their
individual challenges. We worked closely with various States,
meeting with them and having conversations with not only their
educators, but their elected officials, to ensure that
maintenance of effort is being kept, and that the funds are
being moved quickly to help the schools, and getting out to the
LEAs (Local Education Agency) as soon as possible, and we will
continue to do that.
Senator Shaheen. Well, I appreciate that, but that hasn't
happened as expeditiously in New Hampshire, as the school
districts really need it to happen. The ventilation systems,
the HVAC systems are clearly an issue in many of our schools,
and again, when Congress passed these funds, we tried to make
it very clear that we wanted them to be as flexible as possible
for use by the schools. So as you point out, the more the
Department can be accommodating, and working with States on
their needs as quickly as possible, the better.
Secretary Cardona. Thank you, Senator.
Senator Shaheen. So do I have your commitment that the
Department will continue to work with the State of New
Hampshire?
Secretary Cardona. We will be on the phone with New
Hampshire today, Senator.
STUDENT LOAN REPAYMENT
Senator Shaheen. Thank you. All right. I am going to hold
you to that. You and Senator Murray talked a little bit about
the student loan program, and the effort to help address the
challenge that many students are facing. This moratorium is
scheduled to end September 30. I just wonder if the Department
considers the final date of the moratorium, are you looking at
a further extension? One of the challenges we have heard from
people is needing certainty, as they are thinking about going
back to school, and both loan agencies and students themselves.
Secretary Cardona. Yes. You know, we are aiming to provide
as much of an on-ramp for these borrowers as possible. And the
date in September payments are--we are starting in October is
something that we have, but we are continuing conversations
about if that is the best time. No announcements today, but we
continue to have those conversations. We recognize that for
many families the recovery of this pandemic will come around
the same time. Students are going to be returning to schools,
mortgages have to start getting paid, and loans have to start
getting paid. So we want to make sure we are sensitive to the
needs of the borrowers and aware of the other challenges that
they have.
We are going to continue to do as much as we can with our
authorities. Just today we are announcing $500 million in new
discharges for, over 18,000 borrowers who attended ITT
technical college just to make--technical institutes, excuse
me, just to make sure that every authority that we have
currently, we are taking advantage of it to support our
borrowers who are in need. And we do want to provide timely
information, as Senator Blunt also mentioned, and make sure we
have as long an on ramp for these borrowers to start repayment.
Senator Shaheen. Well, thank you. I appreciate that. And I
know that it is a huge concern for borrowers, but the sooner
decisions can be made, I think the better people can plan.
Secretary Cardona. Thank you.
Senator Shaheen. So thank you. Thank you, Madam Chair.
Senator Murray. Thank you.
Senator Moran.
Senator Moran. Thank you, Chairwoman.
INDIVIDUALS WITH DISABILITIES ACT
Mr. Secretary, thank you for your presence today. Let me
just highlight a couple of things that I am pleased with, and
that would be IDEA. The increased funding support for that is
valuable, commitments were made a long time ago, and those
commitments have not been kept for a long time. And a
significant component of our success in education will be our
ability to educate those who need the IDEA aspect of our public
education system.
IMPACT AID
And I look forward to working with you to see that we
continue to provide additional support for those students. I
also want to highlight the importance of Impact Aid; Kansas
with Fort Riley and Fort Leavenworth, they are hugely important
to assist our school districts that have a large presence of
public lands. And I look forward to working with you to see we
support Impact Aid and its ability to level the playing field
in the finance of education in my State.
TRIO
Let me ask a question about TRIO. The Biden Administration
proposed investing $62 billion in new college retention and
completion services. This, to me, seems unnecessary spending on
a duplicative program when we have TRIO programs. And I noticed
in your comments you bragged about the significance and value
of TRIO, but what is the circumstance that suggests that this
is not duplicative or that the resources that you are putting
into new programs could not be utilized in the TRIO programs to
achieve the same outcome?
Secretary Cardona. Thank you, Senator. And I do agree that
the investment in special education is so needed. I have spoken
to families of children with disabilities, in particular,
families with children with autism, who have said, ``you know,
the laptop alone is not going to cut it.'' So I am hopeful that
our students with disabilities are going to get the support
that they need, and that we are on a path to fully funding it.
With regard to the TRIO programs, you know, one thing we
have heard is, students who are in our community colleges or in
our 4-year colleges, due to the pandemic have had to leave. And
there is a lot of concern whether or not they are going to be
able to come back. And we also know that this translates into
high school students who were maybe once thinking about going
to college, not having that opportunity, or having to work now
to supplement the income of the home, and have other factors
that are pulling them in a different direction.
So the $200 million increase in the TRIO programs, to me,
addresses what we know to be the case. What we are hearing from
educators, what we are hearing from families, what we are
hearing from students is that going to college for some
students who might have been considering it, it seems a little
bit further removed. And we want to make sure we are addressing
that, so that we do continue to have students in colleges
across the country.
Senator Moran. Well, my concern is not that you are
increasing the TRIO program by $200 million; it is if TRIO is a
valuable program, which I believe it is, why would we create
new programs with new funding, the $62 billion, without further
utilizing the TRIO programs that already exist? We have a habit
I think in Congress, and I can't imagine that is--an
administration that is immune. We in politics and public policy
have a habit, when we try to highlight the value or the
importance we place on something, we create a new program.
And my suggestion is, my request is an understanding of why
current programs, such as TRIO, would not be the vehicle by
which you deliver new assistance. There are lots of schools in
Kansas and across the country that would love to have a TRIO
program, would love to expand the number of TRIO programs they
have. Those are restrained in many instances because of lack of
funding, and yet we are putting significant new dollars into a
new program, which I would suggest has a pretty similar
objective as TRIO.
Secretary Cardona. Thank you, Senator. Well, we want to
make sure we have opportunities for all students. And I agree
with you, the TRIO program is successful when it is able to get
students into college. And I hear your question. You are
saying, why are we duplicating services if TRIO does similar? I
look forward to working with you to discuss this further. And
we would be happy to have conversations about where you feel we
should be looking at things, and combining them instead of
setting a new programs.
Senator Moran. I look forward to working with you. And I
was particularly interested in your response to Senator Blunt's
question, which I--the answer at least to me, was incomplete.
And I would be welcoming to see why, that the ideas that
Senator Blunt suggested are ones that don't, in your view, have
merit. Thank you.
Secretary Cardona. Thank you.
Senator Murray. Senator Durbin.
Senator Durbin. Thanks Madam Chairman.
Mr. Secretary, thanks for being here.
Secretary Cardona. Glad to be here.
FOR-PROFIT COLLEGES
Senator Durbin. This is not a trick question, but do you
have any idea what percent of post-secondary students in
America enroll in for-profit colleges and universities?
Secretary Cardona. Off the top of my head, sir, I don't,
but I can get you that information.
Senator Durbin. I will tell you what it is. I will give you
the answer, and it is not to trick you. It is 8, 8 percent
post-secondary students in America enroll in for-profit
colleges and universities.
Next question, what percent of student loan defaults in
America are accounted for by for-profit college students?
Secretary Cardona. I have a feeling you are going to share
that answer with me, sir. So, I will, turn it back to you.
Senator Durbin. As I said, I am not trying to trick you,
30.
Secretary Cardona. Thirty.
Senator Durbin. Eight percent of the students, 30 percent
of the student loan defaults. What does it tell us? It tells us
they are enrolling students who cannot finish, won't finish. It
tells us also they are charging money that students cannot
repay even if they are employed, 8 percent, 30 percent. As
often as I meet you here each year, I am going to ask you the
same question, because the numbers don't change.
But here is what is interesting, in the COVID-19 situation,
colleges and universities across America are generally
struggling for enrollment, except for the for-profit schools.
They have seen a 3 percent increase in students. How can that
be? Are they that good? They market and advertise constantly.
You don't have to turn on television, or look into the news
except to see the latest ad for them. Now, the reason I raise
that is because I think that raises a serious policy question
about a branch of higher education that is failing so many
students and yet receives such a handsome Federal subsidy.
Now you have many roles, a Secretary of Education,
educator, principal, president of the university, all these
things, all of the above, and you certainly have the background
for it, but there is one aspect of your responsibility then I
want to delve into that is not often brought up. You are the
Nation's--one of the Nation's biggest bill collectors. You are
a credit agency, you are a banker. And I want to tell you the
record that was written by your predecessor in this field is
not one that I think we want to see continue. For example, if I
might. Public service loan forgiveness. Are you familiar with
it?
Secretary Cardona. Sure.
STUDENT LOANS
Senator Durbin. Do you know what the DeVos administration
did with public service loan forgiveness? I will tell you. 99
percent of those who applied were denied, that is just
outrageous. And then Congress tried to extend the program with
a new version. That was ignored as well. So Secretary DeVos was
channeling Henry Potter and not George Bailey many, many times.
When it came to borrower defense of 108,000 students who
applied, and said that they were the victims of fraud by for-
profit colleges and universities, the DeVos Education
Department, as they were leaving town, denied 80,000 of them
after waiting month after month, and year after year. The lives
of these borrowers have been compromised.
Now, I don't know how familiar you are with ECMC
(Educational Credit Management Corporation). Has your staff
given you a briefing on your collection agency?
Secretary Cardona. Yes. I have heard it.
Senator Durbin. They have?
Secretary Cardona. Yes.
Senator Durbin. Well, I will tell you, the last point I
want to make before I turn it over for your response is this.
They are outrageous. The policies that they use to collect on
student loans, I don't think any of us want to try to defend in
public. If someone goes into bankruptcy court and tries with
the one narrow exception to the bankruptcy code for student
loans, undue hardship, they don't have a chance. ECMC is going
to beat them back, whether or not you are dealing with
veterans, who are so disabled that they can't pay back their
loans, people subsisting on Social Security Disability, people
with terminal illness, they are all beaten back and denied by
your collection agency. So, open question: What would you like
to do about it?
Secretary Cardona. Thank you, Senator Durbin, for bringing
out the facts, on something, that I will be very frank with you
is the top priority at the agency. We have done a disservice
and it is time to act. It is time to have our students at the
center of the conversations there. It is a high priority for me
to make sure that we correct that, it is unacceptable to have a
98-99 percent refusal with public service loan forgiveness.
I had a conversation with students who had to go through
that process and were given the run around. I was frustrated
after that call. They had to hold on and go through different
hoops to try to get an answer. And then the answers were not
accurate, and they had to go somewhere else. So, there is a lot
of work that has to be done.
I recently hired Richard Cordray. He was recently appointed
by the President. And we need to have a consumer protection
mentality, we need to put the students at the center of the
conversation, and we need to make sure that what we are doing
at the agency, is a model for what we expect. And we have to
put our loan providers on notice that we are going to put the
students first.
We have not been sitting around waiting either though, we
have provided a $1.5 billion in relief through borrower
defense, by delivering a billion in full relief to 72,000
borrowers, and approving 500 million in discharges, as I
mentioned with ITT. So, we are taking every opportunity now to
change the culture there. And the message is very clear to
Richard. Fix this. Fix this, and move quickly, and be
transparent, and change the culture that people perceive.
As you pointed out, we have a culture to change and we have
better--we have to implement strategies better. Our students
cannot wait, and we are contributing to the problem, you will
see a turnaround in that. That is a priority for me.
Senator Durbin. Thank you. Channel George Bailey. Thank you
very much.
Senator Murray. Thank you.
I will turn to myself, and then Senator Blunt for a second
round. I would just notify all committee--members and staff to
please tell your members to be here, because if there is no one
else to present at after that time we will wrap up this
hearing. I know Mr. Secretary, you are sad to hear that.
Secretary Cardona. I know.
RATIONALE FOR ADDITIONAL FUNDING
Senator Murray. Mr. Secretary, the President's budget calls
for major new investments in our Nation's public, elementary,
and secondary schools, totaling $66 billion. That is an
increase of $25 billion more than last year's, LHHS (Labor,
Health and Human Services) bill, now Republican and Democrats
were able to work together on COVID relief in our regular
appropriations bills last year. The $125 billion in K-12
education investments included in the American Rescue Plan Act
passed earlier this year did not have bipartisan support. And
some of our Republican colleagues expressed concern that those
funds would not be spent quickly or were unnecessary.
Tell us why you think the additional K-12 investments
proposed in the President's budget are needed on top of the
significant COVID supplemental appropriations that are already
enacted into law?
Secretary Cardona. The technical support that the
allocations provide are critical, and I will get into that, but
let me first talk about how important it is that the President
signal a transformational change in how we view education as
the foundation of our country's growth.
As the First Lady said, any country that out-educates us
outperforms us. So, this administration understands the
important investment in education. And I don't have to remind
you, because you mentioned it in your opening comments, years
of underinvestment in education. I have seen that. I was a
principal when we were asked to do more with less. I had class
sizes that were very high, with teachers who were doing their
very best to meet the needs of students, and those needs kept
increasing, but the funds kept decreasing.
There is a realization here, that if we don't get this
right, so much else is going to suffer. So, when we talk about
what this investment can turn into, it can turn into smaller
class sizes. It can turn into better teacher preparation.
Students are coming back from a trauma-filled year. I spoke to
a student at Harvey Milk School 2 days ago, in New York, who
told me his grandmother and his significant other died in the
last year.
This student is going back to school. If we are not
investing in additional trauma support, training to make sure
everyone, including our school bus drivers, our cafeteria aides
who have been heroes this past year, have the support and
training to help meet the needs of these students when they
come in, then we don't stand a chance. If we are not providing
funds to give students access to digital devices and broadband
so that they can have access to learning wherever they are,
then we lost an opportunity.
The pandemic exacerbated the need. You mentioned it in your
opening comments, the impact that it is having on our poor
communities, in our rural communities students didn't have
access to broadband during the entire pandemic. We cannot
continue under-investing in education and think that we are
going to continue to produce students that are going to lead
the world. We have an opportunity here, an obligation, a
privilege to make sure we are funding our schools, and giving
our educators the tools that they need to be successful. More
importantly, giving our students the tools that they need to be
successful.
Imagine our country, when students don't have to worry
about not having a teacher in front of their classroom, enough
materials, or access to technology so that they could get
access to basic deliverables in education. That is where we are
going. And this bill does that. The American Family Plan boldly
communicates that. And I am excited about supporting it moving
forward.
SIMPLIFICATION OF FREE APPLICATION FOR FEDERAL STUDENT AID
Senator Murray. Thank you. I really appreciate that
response. Mr. Secretary, too many students miss out on college
financial aid that they are eligible for, like Pell Grants, in
part because the application process has been so cumbersome.
Last December we were able to finally reach a bipartisan
agreement to significantly simplify the Federal Student Aid
Application process with the passage of FAFSA Simplification
Act, and that law, by the way, also expands eligibility for
Federal financial aid.
The administration's budget request does include a
significant increase in funding to implement those and other
related changes. But unfortunately, the Department announced
last week, as you know, that some of those changes cannot be
implemented quite as fast as all of us had really hoped. This
is not a criticism of the Department. Everyone wants the law
implemented as quickly as possible, but tell us what the
Department is doing to implement FAFSA as quickly as possible,
including moving forward with key benefits for students on
time?
Secretary Cardona. Thank you. And I recognize it is not a
criticism, but, but we need to get moving on this. And I thank
you, and Senator Blunt, and others who have really pushed this,
and understand the importance of that simplification process. I
have talked to students who said, you know what, that is too
much. Or families, I can't do that. And they have missed out on
opportunity.
So, the simplification process is critically important, but
the reality is we walked into a system that doesn't have the
capacity. As I mentioned in the previous statement, you know,
under-investment leads to results. Well, we have a 45-year-old
computer system that can't handle the changes that are needed,
and that you voted for.
So, we need to move quickly, swiftly, to make sure we are
prioritizing that, that is critically important, the FAFSA
simplification. We are on it. We are going to prioritize that,
again, another area that Richard is really prioritizing. And we
are going to keep you updated. You deserve to be updated on
what progress we are making, what challenges we have, that is a
priority for the agency, and for me as Secretary.
Senator Murray. Thank you very much.
Senator Blunt.
TRANSPARENCY OF COVID RELIEF SPENDING
Senator Blunt. Thank you. Thank you, Chair. On the topic of
new money to schools, Congress provided in the American Rescue
Plan and the COVID supplementals, a total of $190 billion to K
through 12 education. Data provided to us by the Department as
of June 4, less than $9 billion of that has actually been spent
by schools. What can we do to ensure that that money gets
spent, and there is more transparency about how and where it is
being spent?
Secretary Cardona. Thank you for that question. And it
gives me an opportunity to share that as the commissioner of
education, during the beginning of the pandemic and throughout
most of the pandemic, we also had to develop systems that did
not exist before, to distribute money in this unprecedented
time, to make sure that LEAs had the support they needed. And
as the Senator mentioned earlier, in some places that process
is slower than we would like.
So we are in communication with our districts, our State
LEAs, and we recognize, however, and I can tell you from
experience that, you know, a good portion, sometimes 80 percent
of budget is human resources, right? So that money is drawn
down as the contract, or the year goes by. And we recognize
also that this is a 3- to 4-year process where the funds are
going to be used to provide services for multiple years. Also,
contracts that are signed off on are not paid for until the
services are provided. And in many cases that extends years.
So, we recognize the need. I think the transparency, what
you brought up is critically important. We asked that any
planning that is being done for funds with the American Rescue
Plan have transparency that are posted on websites and that
engage stakeholders, so that folks know how the money is being
used. We have a responsibility to ensure every dollar of
taxpayer money is being used to support what it was intended to
use.
Senator Blunt. Right. Now I certainly agree with that. And
I think we actually assumed that more of that money would be
spent on technical support and things that wouldn't have been
part of the normal education system that districts had in
place, as opposed to long-term contracts with individuals, and
things that probably were in their normal and regular budget.
IN-PERSON INSTRUCTION
I hope we are looking carefully to see that that money is
spent, to be more ready for virtual education when we need it,
and different kinds of communication when we need it.
Obviously, as Senator Murray has pointed out, and others have,
the loss of learning in many cases to people who couldn't go to
school, either they didn't engage in a virtual class, or that
wasn't the right way for them to learn. Where do you think we
are going to be in the fall in terms of in-person learning?
What percentage of American public school students do you think
we will be back in school in the fall in person?
Secretary Cardona. Some of the expenditures that take time,
as you mentioned, are critical, virtual learning access,
broadband access, and that does take some time. With that said,
I do expect 100 percent of the students across the country to
have access to in-person learning. April data shows that 96
percent of the K-8 students had an opportunity to learn in
person. But I would argue that hybrid isn't a great option.
In many cases families can't do the hybrid option because
parents have to work. It is all or nothing. I am pushing really
hard to make sure that we are addressing, and we are working
with States, and local LEAs to address whatever factors might
be preventing them from offering full in-person learning, full-
time for all students in the fall.
That is my expectation. And we are having conversations
regularly with different State leaders, and local education
leaders to make sure that that is--the message is clear, and
that the expectation is there. The funds are there. We have to
make it happen for our students, Senator.
STUDENT LOAN SERVICING
Senator Blunt. Let's talk about loan servicing for just a
minute. Certainly, as you pointed out, and I was pleased to be
in involved in trying to simplify those loan forms. Senator
Murray and Senator Alexander and the Authorizing Committee,
last year, did a great job of leading there. Now there has been
a discussion with the Title IV additional servicers, how we
connect better with students--with individuals who have student
loans.
This committee was not supportive of the last plan for the
next generation of student loans. We are about to run out of
the current framework of contracts. I think the current not-
for-profit servicers contracts, and between December of this
year and March of next year, there appears to be no plan to
replace the current system. What I am asking is: Will you use
the authority you have in the fiscal year 2021 labor bill to
extend these legacy of servicing contracts while you work on a
long-term servicing solution? Or do you expect to have a long-
term service solution in place by December of this year?
Secretary Cardona. We are working aggressively to make sure
we have a system that has very high standards for loan
servicers. We have to put the students at the center, while I
don't have an announcement to make today, I will tell you that
we plan on having an update, and we will update you within the
next month or so to share what the plans are with that.
Senator Blunt. Well, I will tell you. I have been very
involved in this discussion. I would like to be updated, and
would hope to be updated before you absolutely have a plan you
are ready to announce. And then if, for whatever reason, that
plan can't be put in place by the time these servicing and
agreements run out I hope you are thinking about the authority
that we gave you to extend those agreements if that was the
best thing to do.
Thank you, Chair.
Secretary Cardona. Thank you, Senator. We will be in touch.
Senator Murray. Thank you.
Senator Braun.
Senator Braun. Thank you, Madam Chair. I remember in our
first or second conversations along the way, we have had a--
kind of a spirited discussion on resources that we put beyond
education, in general. And in my opinion education, along with
one's healthcare, we ought to be doing that as well as
possible, not only through public, but through the private
arena as well.
RETURN ON INVESTMENT IN POST-SECONDARY EDUCATION
And post-secondary education now has the dubious
distinction of being the place where costs are going up more
per year than any other significant sector of our economy. Just
eclipsed a few years ago, the rate of increase in healthcare,
which is a place I have, since I have been here wanted to
reform and try to fix, because I think it is a broken system
there in terms of what we do through the private sector, and
through government, because we have got the entity itself, the
system that doesn't deliver, it has cost us in healthcare twice
as much as what it does in other countries.
So, I think it is silly to pour more resources in anything
that is not delivering outcomes that look like they are at
least headed in the right direction. So do you think when it
comes to the results, and let us look at post-secondary
education, I will come back to secondary in a moment. Do you
think we have been getting a good bang for our buck?
Secretary Cardona. There is always room for improvement,
Senator. And I can assure you that the team that we are
assembling recognizes the importance, and the moment that we
have to make sure we are improving access and affordability.
Again, I mentioned earlier, the American Families Plan provides
opportunities for students to access community colleges for
free. We know how important that is to give them an opportunity
to join the workforce with skills that they need to be
successful. And that the earning potential of graduates of
community colleges can be up to 21 percent higher.
We have work to do and we are going to be aggressive to
make sure that students are getting a good return on investment
in post-secondary education. And we are addressing the issues
that exist, where students are being taken advantage of, or
sold a bill of goods and never delivered on. We are on that.
And that is a priority for me.
Senator Braun. So my observation before I got here is that
you generally don't pour resources into something until you
look at what you have got, that you are trying to rebuild, re-
energize, or make better. And 41 percent increase over fiscal
2021 levels is embedded in this budget proposal. And my
observation, from being on a school Board for 10 years, to
wrestling with education at the State level as a State
legislator, it is not about spending more money, it is really
more about finding how we change the system.
To me it is analogous to healthcare. And as long as we are
here, since we live with no constraints, now added in the two-
and-a-half years I have been here, nearly $10 trillion in
national debt. The need to be a little more entrepreneurial, a
little more concerned about changing the paradigm. And here I
see most of this just pouring more resources into something
that doesn't need to tell us any more clearly, that it is not
delivering the goods.
SECONDARY EDUCATION ALIGNMENT WITH JOB MARKET
Before I run out of time, let me pivot back to, the same
point would be made in secondary education, before you get to
college. College is runaway with costs that even parents are
really scratching their heads. Is it worth it to send my kid
into a system that 50 percent of the kids that go there don't
pursue it, and many get a misguided degree, and employers don't
have a market for?
Why don't we try to get it better at the secondary level
and match training and skills with the high-demand, high-wage
jobs that all of us have out there? My State of Indiana,
checked with my kids, I think we have got 70 to 80 job openings
in our own company, out of a total employment of 1200. We don't
need any more 4-year degrees, because the jobs that we have in
a State like Indiana, where we ship out twice as many 4-year
degrees as we use in the State, we need better skills that are
being delivered out of high school.
I look at a place like Garrett High School, west of Fort
Wayne that catches kids and, obviously, parents, when they are
fifth graders, before they go to middle school. That is
something that would cost no more money, but would change the
dynamic of where we need to change our emphasis in how we do
things. And until education does that, until healthcare does
that, I really think we are just going to be borrowing more
money and putting it down a dubious hole. I won't refer to the
word that comes to mind. So, a quick comment on that.
Secretary Cardona. Thank you. I agree with you. If we do
what we have done, we are going to get what we have gotten. So,
you know, the plans discussed CTE (Career and Technical
Education) changes. We really, if you recall, my hearing, one
of my goals as Secretary of Education is to make sure we evolve
our secondary schools to meet the demands of the workforce, and
the careers that are available today, as you mentioned, in your
own community.
So, this is something that I am eager to work with. Not
only in the budget do we see that in there. And it is not just
resources, it is the change in mindset. We are going to get
there. And I look forward to working with you on that. I know
the Jobs Plan has funds for that, the Families Plan. I know the
President gets it, it is in the budget, and we are going to
make it happen. And I look forward to working with you on that.
Senator Braun. Thank you. And I would invite you to take a
road trip to Indiana and visit some of the places that are
setting the trend on what we, as employers, need which is a
better elementary and especially secondary education, before
you start pushing kids into a broken system after that. Thank
you.
Secretary Cardona. Look forward to working with you on
that.
Senator Murray. Senator Reed.
Senator Reed. Thank you very much, madam Chairwoman.
SCHOOL INFRASTRUCTURE
Welcome, Mr. Secretary. Your experience as a State
Commissioner of Education is, I think, invaluable because you
have seen these issues up close and personal, as they used to
say on television. And one of the issues I hope is not
debatable is the poor status of school infrastructure, and this
is not just an urban issue, it is a national issue.
I have been working very hard to get resources in for
infrastructure repairs in schools, and also in the context of
infrastructure repairs, you can do a lot of things like, change
the heating system to be more efficient. We discovered in the
pandemic, in Providence they had to teach all winter with the
windows open, because the HVAC system, and you probably had the
same situation in Connecticut, the HVAC system would not
support a safe instruction, and was probably built in 1930, et
cetera.
I am pushing very hard to get $100 billion in the Jobs Plan
for the schools. And I hope you can assist me in doing that,
with the President and with my colleagues.
Secretary Cardona. Thank you, Senator. Part of the ``Help
Is Here Tour'' we visited about nine or ten different States,
and visited about ten different schools. And as I mentioned in
an earlier response, the needs in different communities, post-
pandemic, were different. And one really stood out to me. I was
in Philadelphia, and I visited schools that were over 120 years
old. You know, where the windows are shut with paint.
Senator Reed. Lead paint?
Secretary Cardona. Yes. The students, they need better. And
it really just brought to the surface what educators have known
for years; that facilities do matter, but what is the first
thing that goes in local budgets when there is not enough
funds, the facilities' maintenance. I remember as commissioner
of education, talking to district leaders who said, our system
hasn't been touched in years, the maintenance of the system
hasn't been touched in years, the filters haven't been changed
out.
I learned more about MERV 13, MERV 15, more than I ever
thought I needed to know. But the point is there has been
negligence on facilities for years. And what we are finding is,
in order to get students back into school safely and ensure a
safe learning environment where the community could feel
confidence in their schools. When we talk about reopening
schools, we have to take that into account. So, I agree with
you. Part of the Jobs Plan has the upgrade and building new
public schools where it is needed, the $50 billion over 5
years.
But the community colleges also need the support, and the
$12 billion over 5 years there, is a commitment to making sure
that our facilities are safe places for our learners, for our
educators. So that kids go to school, they attend regularly,
and they have a learning environment where they can grow. So, I
agree with you there, wholeheartedly, Senator.
Senator Reed. Well, thank you. And I must confess part of
my passion is the fact that my father was a school custodian.
And so he would get to--in fact supervisor custodian--so he
would get those calls in the middle of a winter night to go fix
the boiler that was installed in 1927 or something like that.
Secretary Cardona. Exactly.
LITERACY
Senator Reed. A further question. I had an interesting
discussion with adult education providers, and they reported
that 95 percent of the students that they are serving, come to
them with virtually no literacy skills. They can't read, they
might graduate from high school, or at least going the length
of time they have to, but they can't read. And if they can't
read, it is very difficult to train someone for a job,
particularly in the sophisticated, post-industrial economy.
Secretary Cardona. Right.
Senator Reed. One issue I think is if making sure we know
what at least the rates are. And I have just wondered, do you
have national, local, and States' reliable statistics about
literacy?
Secretary Cardona. We do, we have data that we are tracking
in terms of where the States are. But we have to do more. We
have to do more to make them transparent, and to ensure that
the funds that are being used through the American Rescue Plan
are aimed at addressing those literacy gaps. I will tell you;
we know in education that if a student is not reading by 3rd
grade, you are going to be intervening for the rest of that
student's school career.
And in the process, probably disengaging that student in
ways where they can't take the courses that they want to
select, or think about college as early as they need to, to
make sure they have the same opportunities as other students.
But that is where I also believe, sir, that the American Family
Plan and the commitment on early childhood education.
Three- four-year-old programs, I saw as a principal, when
5-year-olds walked into the kindergarten classroom on day one,
we knew which students had access to high quality programs. We
could tell which students didn't, and we knew, day one,
kindergarten, which students were going to need intervention
and support. So you pay now or pay later, we really need to
focus on early childhood education, and literacy skills early,
science-based, research-based practices, to make sure that we
are allowing our students to have the best opportunity in life
by reading by 3rd grade.
Senator Reed. I agree, but we also have to pay attention to
adults who will miss these prospective reforms but still have
low literacy skills.
Secretary Cardona. Right.
Senator Reed. Thank you. My time has expired.
Secretary Cardona. Thank you. Thank you, sir.
Senator Murray. Senator Hyde-Smith.
Senator Hyde-Smith. Thank you, Madam Chairman. And thank
you, Mr. Secretary, for being here. I absolutely loved the
background that you have, and it is very obvious that you
really get it.
Secretary Cardona. Thank you.
Senator Hyde-Smith. And I appreciate that, because I can
tell by your passion that you know exactly what these students
are going through. So that I truly want you to know how much I
appreciate that.
Secretary Cardona. Thank you.
FLEXIBILITY IN USE OF COVID FUNDING
Senator Hyde-Smith. As we know from COVID, so many kids got
just really far behind in so many areas, and great concern, not
just in Mississippi, but everywhere. But Mississippi has
recently received significant American Rescue Plan funding to
help reopen our schools. The reality is that most Mississippi
schools have been open for in-person learning for nearly 10
months, as many Mississippi schools resumed classroom
instructions last August. We really got back in quick with good
results, and made some good decisions there that our leaders
made. But the school year for most Mississippi schools ended in
early May, and students are already out for their summer break.
In your submitted testimony you stated that the plans to
reopen are bold, and will require coordination among key
stakeholders at the Federal, State, and local levels. However,
this statement, and several others from the Department, seem to
ignore the fact that many other States, like Mississippi, have
been opened since fall of 2020. So, we have this money, but we
have already been open, but how much flexibility are schools
being given to use the American Rescue Plan funding? Because
that is the calls that I get, and that is the questions that I
get, from my schools and my educators.
Secretary Cardona. Yes. Thank you, for first of all, for
your comments, and for the thoughts that you are bringing up on
behalf of the constituents you serve. And like you, my own
children have attended since August, and I have been fortunate
that some of the students in Mississippi that were able to
attend in person, early, safely. That is critical.
So, we know, as I mentioned in a previous response that the
impact of COVID effected some regions differently than other
regions. And we have to be aware of that and provide the
flexibilities where needed. We recognize that in some places,
while students have been in school, it might have been in a
hybrid model, or some students have had access more than other
students, due to, whether it is confidence, or trauma with the
pandemic, some students will still need support even if they
are going into school, maybe half-time, or full-time even.
We also know that summer learning will help bridge those
gaps of learning that we experienced through the disruption of
COVID-19. So, flexibility is important. And what we are trying
to do is balance flexibility while making sure that the impacts
of COVID-19 are being addressed with the American Rescue Plan,
as was the expectation from Congress.
So, we are working closely with States to communicate
flexibilities, and we are available, if there are questions in
Mississippi, to discuss how their plans are being rolled out,
and questions that they might have around flexibilities, or
adherences to specific requirements that might have come out of
the agency.
Senator Hyde-Smith. So, all we have to do is really contact
your Department and for these individual questions, because I
know they have some really good ideas, but we want to make sure
we are following the guidelines the way that we are supposed to
be doing that.
Secretary Cardona. Sure. Senator, you know, we do encourage
innovation also. So, we look forward to hearing it. As matter
of fact, we will reach out, just to make sure that we are
partnering with Mississippi to make sure that their questions
are answered, and that we can promote as much flexibility to
meet the needs of the students as needed.
CHARTER SCHOOLS
Senator Hyde-Smith. Thank you. And I have a little time
left. We have seven charter schools operating in Mississippi
and, you know, charter schools have given parents the
flexibility to decide which schools best fits their child's
needs, individually, and not the government. In some instances,
charter schools also have the freedom to adapt their classrooms
as they see fit. And over the years, charter schools have seen
increases in academic gains. We have had a lot of success
there, which allow children more opportunities as they continue
in their academic career.
And with your commitment to ensuring all students have
access to a quality education, how will you support school
choice in order to expand access to higher quality charter
schools?
Secretary Cardona. I am a big proponent of high-quality
schools for all students across the country. And I recognize
that students have options and, public charter schools are
options for students. And I feel that all schools should be
held to similar standards of accountability. And I think that
is where I stand with that. I have seen examples of schools
that needed a lot of intervention, but I have also seen
examples of schools that really met the needs of the student
and the families in a charter school.
Senator Hyde-Smith. Because we really had some good luck.
We had a Senator Michael Watson, State Senator at the time,
really worked on this a long time. He is Secretary of State
right now. But it really proved that we made a lot of ground
there that were good decisions and beneficial. So, you will
continue to support funding for the charter school program? Is
that what you are saying?
Secretary Cardona. Yes. The President made it very clear.
You know, we don't--we are not going to be promoting a private
charter school growth, but we are endorsing the programs that
exist now where students are taking advantage of public charter
schools.
Senator Hyde-Smith. Great. Thank you very much.
Thank you, Madam Chairwoman.
Senator Murray. Thank you. My understanding is Senator
Manchin is going to walk in the door behind me at any moment.
He will be our last questioner.
STATE PLANS FOR ESSER FUNDING
While we are waiting for him. Mr. Secretary, I just wanted
to thank you and your staff for all the hard work implementing
the American Rescue Plan Act and other COVID-19 Relief
Legislation, and the fiscal year 2021 Appropriations Bill. I
know you got a lot on your plate. And I know the processes--the
Department is really in the process of reviewing the State
plans that are being submitted for each State's final one-third
share of ESSER (Elementary and Secondary School Emergency
Relief Fund) allocations under the American Rescue Plan.
But one of my priorities really is, is that the
legislation--in the legislation is the required State and
school district set asides for evidence-based interventions
that address the academic, and social, and emotional needs of
students of color, students experiencing homelessness,
underserved students.
Secretary Cardona. Yes, right.
Senator Murray. And I really appreciate the Department's
template for State plans that include descriptions of state
strategies, for carrying out these required activities, and
strategies for States to support these district plans. Can you
just assure us that the Department will only approve high-
quality plans that effectively address the requirements of the
law?
Secretary Cardona. Yes. As I said at the beginning, that is
where the honor lies, making sure that we are serving our
students. And on behalf of the 50 million students, when we
review those plans, we want to ensure that we are building back
better, and that the plans are addressing the inequities that
were exacerbated by the pandemic, that the plans engage our
stakeholders in different ways, because that is critically
important. Many folks who were already struggling in school
prior to the pandemic are now further away. So, we need to
engage them to make sure that the schools that we are reopening
are welcoming places that are able to meet their needs as well.
Senator Murray. Well, thank you. I really appreciate that
commitment. And I just ask that you keep my staff updated on
the review of those plans. As you know, high quality plans are
only successful if they are effectively implemented. And I know
your Department has hosted webinars, and established a
clearinghouse, and taken some other actions, which I really
appreciate.
And while we are waiting for Senator Manchin, share some
thoughts on how the Department will support and monitor those
plans.
Secretary Cardona. Senator, I appreciate you mentioning the
actions that we have taken. We have--take your time. This is
something I want to talk about. So, we do have a best practices
clearinghouse, innovation doesn't come from Washington, D.C.,
alone. In fact, across the country, we have over 1,100
submissions of innovative practices to reopen schools, and
engage those students that were hardest to engage during the
pandemic.
So, we are lifting our best practices from across the
country. And, you know, I always say, we are going to heal
together, we are going to learn together, we are going to grow
together. And the tools that we have are at the disposal of the
districts now are tools that were developed with them, not for
them, with them. And I have to say that, you know, we are
continuing that conversation. We are having an equity summit
next week, where we are inviting everyone to come take a look
at what it means to rethink addressing inequities, and be bold.
Our students deserve it. Looking forward to that.
Senator Murray. Thank you. Thank you.
Senator Manchin.
Secretary Cardona. Senator.
Senator Manchin. Did I interrupt you?
Secretary Cardona. No. Not at all.
HOMELESS EDUCATION
Senator Manchin. Thank you so much. Let me, a few things.
And I appreciate so much, Secretary, on the difficult job you
have. And I want to go through a few things because a lot of it
either makes sense or doesn't make sense. But the main thing
is, I have really a problem with homelessness with children.
And I noticed that the budget hadn't been increased for that.
But I know that we put, myself and Murkowski, and all of our
colleagues on both sides of the aisle supported $800 million
going into that. But if the base doesn't move because, if it
hasn't moved, it has been flat.
Secretary Cardona. Right, right.
Senator Manchin. It is growing. I hope you would show
attention to that. I know we were able to meet it this year,
but we won't be able to meet a year after that.
Secretary Cardona. Right.
Senator Manchin. Okay? So, if you can.
Secretary Cardona. Sure. And I appreciate that. I recall
experiences with students in the district where I worked
before, who were experiencing homelessness. And I was always
amazed at how they were able to engage in learning, and be a
part of extracurriculars with housing instability, not knowing
where they were going to go.
And that reduces the bandwidth for learning when you are
thinking about where am I going to sleep tonight? So, the
money, the $800 million for homeless education through ARP
(American Rescue Plan) is critically important. But I also want
to share that the focus on community schools--the focus on
community schools, and the vast proposal in the American
Families Plan, is also intended to address some of these issues
that lead to homelessness, right?
Senator Manchin. And I think homelessness, and I was just
asking, we need to describe it make sure we are all on the same
page.
Secretary Cardona. Right.
Senator Manchin. McKinney-Vento describes homelessness one
way, and the Department describes it another way. So, they
might show in West Virginia we don't have that many. We know we
have because we are basically talking to the schools. We know
kids have been disrupted, things like that.
Secretary Cardona. Right.
Senator Manchin. We need to get that definition on the same
wavelength. And let me go through a few more.
Secretary Cardona. Sure.
Senator Manchin. So, on that one there, and the second
tranche of money is going to supposed to come out for them, the
McKinney-Vento. These are very, very important. The other thing
I wanted to talk about is community college. Okay. First of
all, I will talk about pre-K 3 and 4, which I agree one million
percent.
Secretary Cardona. Yes.
Senator Manchin. We have been doing it when it wasn't even
popular.
Secretary Cardona. Right.
Senator Manchin. Let me tell you why we did it. Just on
nutrition, just giving kids some stability in life. And we had
a challenge in Appalachia. So, we had to. And I did it when I
was governor, we have done it, and it has worked out great. So,
I am glad the whole Nation, because you cannot get ahead of the
curve if you don't start at 3 and 4 years of age.
Secretary Cardona. Right.
FREE COMMUNITY COLLEGE PROGRAM
Senator Manchin. God bless you on that. Where I disagree a
little bit on community and technical colleges, and I disagree
on free.
Secretary Cardona. Mm-hmm.
Senator Manchin. And I said, let me earn it. I have told
people this and, you know, someone said free college. I said, I
have a child, who is up 30-40 years of age. If they had had
free college, they would still be in college. They never left,
they loved it so much. That is just a little tidbit on that.
But on community, here is the thing. Community technical
colleges usually trained to skills, skill sets. It is not the
same as a 4-year baccalaureate, or it gives them a segue,
because their grades might not have been good enough. Okay. I
understand all that. But most of it is skill sets.
If we could determine the skill sets we need in different
categories, in different parts of our country. So, if our
community colleges are training for one thing in West Virginia,
you are training for another thing in California, another thing
in different parts of the country. If those skill sets are met
by someone who is going, and we have a Stafford loan that we
basically guarantee federally, you take the loan out. You, you
accomplish that within a 2-year period of a community college,
and you have that associate degree, then it should be forgiven.
Let them earn it. Don't give it on the front end, earn it
on the back end. You be surprised how much more they respect
and appreciate something they have earned, than something you
have given them. That is the only thing I have said about that,
because I can tell you, as a parent, it works and works very
well. And it is very efficient. You know, that would be like
the same as a kid getting it: Where is my allowance, dad? And
he is 35 years old. Do you understand where I am coming from?
Secretary Cardona. Yes. Thank you, Senator. And I look
forward to hearing more, and working with you, too. We need to
make sure that all students have access.
Senator Manchin. Right.
Secretary Cardona. We need to make sure that all students
have either access to the skilled development that you
mentioned. And you are absolutely right, the workforce needs--
--
Senator Manchin. And for a time, either way.
Secretary Cardona. But also, it might be an opportunity for
students who don't think that they have the potential to go to
college, to get access to a 2-year college and then continue on
to a 4-year school.
Senator Manchin. No problem.
Secretary Cardona. So, we are widening the net, and we know
the earning potential is greater when you graduate college. And
I can tell you, 21 percent for community college graduates, I
believe this is good for the economy in the long term. It is
really creating a workforce with higher earning potential,
better discretionary income, and I do think it is----
FINANCIAL LITERACY
Senator Manchin. What is the dropout rate? You ever look at
the dropout rate? Do you know why student loans are so high?
Because we cannot even demand that they have financial
literacy. They come in, we cannot even have a registrar say,
no, you are not getting that much, Miguel, you don't, you only
need $4,000. I know you qualify because your family is for
$11,004, but $4,000 is going to be fine. They cannot say that.
So, end up stacking up debt, 2 years they flunk out or they
quit because they haven't had to pay any payments out. And all
of a sudden it comes tumbling down.
Secretary Cardona. Yes.
Senator Manchin. We do a horrible job of managing student
debt, but we are talking about, eliminated before you have
people responsible for it.
Secretary Cardona. We are going to be aggressive on the
student debt, and making sure that we are communicating, that
we are advocating for students, working with students, putting
the students at the center. I am eager to get going on that and
get started.
Senator Manchin. I cannot wait to work--I cannot wait to
work with you.
Secretary Cardona. Same here.
Senator Manchin. There are so many good things--and I would
love to----
Secretary Cardona. Same here. Thank you, Senator.
Senator Murray. Thank you.
Senator Manchin. Thank you.
Senator Murray. That will end our hearing today. I want to
thank all of our fellow committee members for their
participation. Secretary Cardona, thank you for your very
thoughtful answers today, and to talk about the President's
budget. I do look forward to continuing to work with you, to
support students and families in our country.
ADDITIONAL COMMITTEE QUESTIONS
For any senators who wish to ask additional questions,
questions for the record will be due Friday, June 25, at 5 p.m.
The hearing record will also remain open until then for any
member who wishes to submit additional materials for the
record.
Secretary Cardona. Thank you.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted to Hon. Miguel Cardona
Questions Submitted by Senator Patty Murray
Question. I'd like to follow-up on our discussion during the
hearing about implementation of fiscal equity requirements under
current law. These requirements include resource allocation reviews by
states, school districts and schools identified for support and
improvement. Earlier this year, the Government Accountability Office
(GAO) reported most states (43 of 51) indicated helping districts
identify resource inequities as somewhat or very challenging based on
survey results prior to the pandemic.
Please share the Department's plans in fiscal year 2021 and fiscal
year 2022 for supporting, enhancing and monitoring resource allocation
reviews by state and local education agencies and schools?
Answer. Section 1111(d)(3)(A)(ii) of the Elementary and Secondary
Education Act of 1965 (ESEA) requires a State educational agency (SEA)
to periodically review resource allocation to support school
improvement in each local educational agency (LEA) in the State serving
a significant number of schools identified for support and improvement.
This requirement is part of the Department's monitoring protocol for
Title I, Part A (available at: https://oese.ed.gov/files/2020/08/SEA-
Protocol-Title-I.docx, under ``Support for LEA and School
Improvement''). Specifically, the protocol asks each SEA to describe
how it periodically reviews resource allocation to support school
improvement in each LEA serving a significant number or percentage of
schools identified for comprehensive or targeted support and
improvement.
In addition, the Department has been providing on-going technical
assistance to States regarding this requirement. For example, the State
Support Network, created by the Department in 2016 to provide technical
assistance to support the transition to the Every Student Succeeds Act
(ESSA), hosted a community of practice (CoP) with 13 States in 2019
that focused on planning for school resource allocation reviews. Please
find more information and several resources here: https://oese.ed.gov/
resources/oese-technical-assistance-centers/state-support-network/
resources/resource-allocation-reviews-community-practice-summary/. The
State Support Network also created a number of tools to assist with
school improvement planning, including Tools for School Improvement
Planning, a CoP for ``Implementing Needs Assessments'' and other
resources for developing needs assessments. It also published several
blogs about using school financial data in decisionmaking, including
``Going Beyond Finances in Resource Allocation Decisions''.
Further, the Department's Comprehensive Centers have provided
individualized technical assistance to several States on this topic. In
the past 2 years (since the 2019 competition established new TA
providers), the Comprehensive Centers have been supporting States in
their implementation of ESEA requirements. Two centers specifically
have provided assistance to States on resource allocation reviews. The
Region 15 Comprehensive Center is supporting Utah in the State's work.
WestEd and the Region 15 Comprehensive Center have worked on an equity
driven resource allocation framework during another State collaborative
session. The Region 13 Comprehensive Center has worked with the
Oklahoma State Department of Education to design a Resource Allocation
Review toolkit. The Region 2 Comprehensive Center is supporting efforts
in Connecticut and Rhode Island to develop a process to conduct
resource allocation reviews.
The fiscal year 2022 request would build on these efforts to
strengthen fisal equity through the Title I Equity Grants proposal,
which would require each State to collect and make publicly available
detailed data on the allocation of State and local education funding to
school districts and schools. The proposal also would require the use
of a consistent definition of per-pupil expenditures to support
identification and mitigation of disparities in funding for high-
poverty districts and schools, along with goals, interim targets, and
timelines for closing identified gaps.
In addition, our proposal would encourage States to undertake a
comprehensive review of their school finance systems through a $50
million reservation for voluntary State School Funding Equity
Commissions that would (1) identify funding and educational opportunity
gaps based on measures of equity and adequacy; (2) through extensive
community engagement, develop detailed action plans for addressing
existing gaps that include goals, interim targets, and timelines for
closing identified gaps; and (3) report on progress toward these goals
and targets.
Question. The Every Student Succeeds Act (ESSA) established a
policy requiring the reporting of actual personnel and nonpersonnel
expenditures, disaggregated by Federal, state and local source of funds
for each school and school district in each State. Transparently
providing this information would allow a range of uses from parents
seeing easily how their school's spending compares to other schools in
the district to other stakeholders using the information to participate
in equity conversations on differences within and between states.
What is the Department's plan for ensuring states and school
districts comply with ESSA's policy requiring the reporting of actual
personnel and nonpersonnel expenditures, disaggregated by Federal,
state and local source of funds for each school and school district and
such information is made available to the public in an accessible and
understandable manner?
Answer. The Department will ensure that SEAs and LEAS meet the
report card requirements in ESEA section 1111(h), including the
requirement to report per-pupil expenditure data. As you are aware, to
help facilitate compliance with these requirements, the Department
released non-regulatory guidance on State and local report cards in
September 2019 (available at: https://oese.ed.gov/files/2020/03/report-
card-guidance-final.pdf). This document includes detailed guidance for
SEAs and LEAs regarding how to calculate per-pupil expenditures. The
guidance encourages SEAs to establish uniform statewide procedures for
calculating per-pupil expenditures so that that data are uniform,
understandable, and comparable across each LEA and school in a State.
To help ensure SEAs and LEAs comply with applicable requirements,
including reporting per-pupil expenditures, a complete review of State
and local report cards is included in the Department's Title I, Part A
monitoring protocols, which are found at: https://oese.ed.gov/offices/
office-of-formula-grants/school-support-and-accountability/performance-
review/). An important aspect of our consolidated monitoring is a
thorough review, for each State monitored in a particular year, of the
State's report card to ensure that it includes all required elements.
In addition, each January, the Department reviews each State website to
determine if States and districts were in compliance with certain
report card requirements, including reporting per-pupil expenditure
data. The Department shares the results of its review with each State.
Over the past few years, the Department has initiated several
technical assistance activities through the State Support Network, a
four-year technical assistance contract begun in 2016 to support States
and districts as they transitioned to the new ESSA requirements. Some
of the technical assistance initiatives focused on State and local
report cards, several of which have had a particular focus on per-pupil
expenditure data. For example, in 2018 a community of practice
involving Arkansas, Montana, North Dakota, New Mexico, Nevada, and
Oklahoma focused on improving financial transparency. Other relevant
communities of practice have focused on data quality, State and local
report cards, and resource allocations. Information about these
communities of practice can be found at: https://oese.ed.gov/resources/
oese-technical-assistance-centers/state-support-network/resources/. The
Network also created the ``Financial Transparency and Reporting
Readiness Assessment Tool.'' This tool can help States and districts
meet the ESSA reporting requirements by identifying and analyzing
school level expenditure data. This tool contains two components--a
self-diagnostic framework and an analysis tool--that are designed to
help districts and States understand the dynamics of school-level per-
pupil reporting in their own district financial data. The tool can be
found at: https://oese.ed.gov/resources/oese-technical-assistance-
centers/state-support-network/resources/financial-transparency-
reporting-readiness-assessment-tool/.
The Department is also funding the National Comprehensive Center's
work with Georgetown University's Edunomics Lab to improve the quality
and utility of school-level per-pupil expenditure data that is reported
on State and local report cards as required under ESSA. Edunomics'
initial work through this project involved analyzing the utility and
usefulness of the school-level per-pupil expenditure data reported by
each State (https://edunomicslab.org/state-data-tracker/). The current
phase of the National Comprehensive Center's project with Edunomics is
focused on working with a little under 20 school districts across
different States to analyze each district's school-level expenditure
data and build staff capacity to use data to drive decisionmaking for
school improvement and equitable allocation of resources. After
piloting tools and communication materials with these school districts,
Edunomics will create a data visualization tool that all districts will
be able to access to analyze their school-level per-pupil expenditure
data and use it for finance decisionmaking.
Additionally, the Department's National Center for Education
Statistics (NCES) has been working with over 20 States to improve the
quality of expenditure data reported through a voluntary data
collection. Recently, NCES issued a report on highlights of school-
level finance data that were previously reported (https://nces.ed.gov/
pubs2021/2021305.pdf).
The Department looks forward to expanding and building upon these
efforts.
Question. I appreciate the Secretary's commitment to properly
implementing the American Rescue Plan Act of 2021, including required
state and school district set-asides for evidence-based interventions
that address the academic, social, and emotional needs of students of
color, students experiencing homelessness and other underserved student
groups disproportionately impacted by the pandemic.
Please describe in detail how the Department will support, monitor
and enforce requirements of the Elementary and Secondary School
Emergency Relief Fund (ESSER) related to these set-asides and
implementation of State and district ESSER plans related to these state
and district learning loss requirements.
Answer. We support these requirements through the State plan
process that the Department established, technical assistance efforts,
non-regulatory guidance documents, and ongoing communication with
States through our program officers.
The ARP ESSER State plan template requires grantees to describe how
they will use each required set-aside under the ARP Act. We will
monitor grantees against their approved ARP ESSER State plans as well
as statutory requirements. As needed, the Department will issue any
findings and develop corrective action plans to address those findings.
We are committed to working with grantees to resolve any findings.
In July, the Department issued a notice inviting comment related to
data submission requirements for the ESSER (including ESSER I, ESSER
II, and ARP ESSER) annual performance report (APR). The public is asked
to comment on data quality and burden-related concerns related to
collecting data on evidence-based summer learning or summer enrichment
programs, evidence-based afterschool programs, and extended
instructional time, among other items. After the data collection
instrument is finalized and APR data is submitted, the Department will
review grantee submissions to identify technical assistance needs and
inform future monitoring of grantees.
Question. Department regulations state the Secretary may make a
continuation award for a direct grant for a budget period after the
first budget period of an approved multi-year project if Congress has
appropriated sufficient funds for that purpose and the grantee is
making substantial progress toward meeting the goals of the project,
among other factors. The regulations further state ``In deciding
whether a grantee has made substantial progress, the Secretary may
consider any information relevant to the authorizing statute, a
criterion, a priority, or a performance measure, or to a financial or
other requirement that applies to the selection of applications for new
grants.''
For fiscal year 2018 and 2019, how many direct grantees did not
receive a continuation award for any reason? How many of such denials
were related to the lack of substantial progress on performance? How
much total funding was associated with such denial of a continuation
award due to lack of substantial progress on performance?
Answer. In fiscal years 2018 and 2019, 11 grantees received a
continuation award of $1, which is equivalent to a denial of a
continuation award but is the amount required to keep the grant award
active so grantees can complete work already funded. Of those, 10 were
at least in part because of issues related to substantial progress. The
total amount impacted grantees requested in their initial grant
applications for the budget period not funded is approximately $38
million. In addition, the Department reduced continuation awards for
other grantees if appropriate based on lack of substantial progress or
other considerations. Further, some grantees asked for their
continuation award to be reduced or for the grants to end early due to
their concerns about not being able to implement their projects
Question. What policies or criteria have the Department adopted for
considering information in making a determination of substantial
progress? If none, how does the Department consistently evaluate
substantial progress?
Answer. The Department follows the procedures for non-competing
continuation awards as set forth in 34 CFR 75.253 and has internal
policy about how to determine substantial progress, including what
should be included in documentation for non-competing continuation
award documents. The policy includes considerations to support
decisionmaking, including program- and grantee-specific context,
monitoring grantee performance, and discussing performance concerns
with grantees. There are also internal discussions across offices to
share about office practices and lessons learned, particularly in light
of the COVID-19 pandemic and how best to consider associated
disruptions to the project activities in making substantial progress
determinations.
Question. Earlier this year, the Department withdrew a notice
inviting applications for equity assistance centers (EACs) issued by
the previous administration and extended existing contracts for 1 year.
Equity Assistance Centers can play an important role in addressing
racial and other equity concerns and designing and implementing school
desegregation plans.
What are the Department's plans for the new notice inviting
applications?
Answer. The Department plans to publish a notice inviting
applications for new awards in the Federal Register in early 2022.
Question. How does the Department evaluate the resources needed for
EACs to carry out this important work? Please share any analysis
completed that supports the sufficiency of the $6.5 million requested
for EACs to delivery timely and effective services across the entire
United States.
Answer. We have not carried out any detailed analysis of EAC
resource needs, but we do ask the EAC grantees to tell us in their
annual performance reports the percentage of technical assistance
requests received from organizations that they accepted during the
performance period. Annually across 2017 to 2020, the EACs were able to
accept between 95 percent and 98 percent of the technical assistance
requests they received from the field.
Question. As of June 11, more than sixty percent of the CARES
Elementary and Secondary School Emergency Relief (ESSER) funds ($8
billion of $13.2 billion) have been recorded as spent and outlaid from
the Federal Treasury, while $2.1 billion of $54.3 billion provided
through ESSER in the Coronavirus Response and Relief Supplemental
Appropriations (CRRSSA) Act, 2021 and $25 million of $81 billion
obligated from ESSER funds in the American Rescue Plan (ARP) Act of
2021 have been so reported. The Department also is in the process of
reviewing state plans for the obligation of the remaining one-third of
the ARP ESSER funds. However, earlier this year the Government
Accountability Office reported ``Federal spending data alone provide an
incomplete picture of states' and school districts' spending'' noting
``there is often a significant gap between when a district uses the
funds and when those funds are reported as spent in state and Federal
reporting systems''.
Please describe actions taken and planned by the Department to
provide a more complete reporting of the use and status of ESSER funds.
Answer. Section 15011 of the CARES Act specifies the reporting
requirements for covered programs. Existing reporting requirements,
established under the Federal Funding Accountability and Transparency
Act of 2006 (FFATA), Public Law No. 109--282, as amended by the Digital
Accountability and Transparency Act (DATA Act), Public Law No. 113--
101, were deemed sufficient to meet many of the reporting requirements
for ESSER fund program. Specifically, States were required to report to
the General Services Administration's FFATA Subaward Reporting System
(FSRS), the amount of ESSER funds granted to school districts. These
data are required to be reported directly from States and are made
available to the Department and the public through USAspending.gov.
To further meet the Section 15011 reporting requirements and
additional reporting requirements described within the ESSER
Certification and Agreements, the Department created an annual
reporting process for ESSER grantees (States). The annual report
captures the following information (1) award and outlay information
from the Department to ESSER grantees (States); (2) award and outlay
information from ESSER grantees to their subgrantees (school districts/
LEAs); and (3) subgrantee expenditure data. States were required to
provide these data for district awards/expenditures made March 13,
2020--September 30, 2020 to the Department in early 2021. States will
be required to provide additional reports on ESSER funds annually
thereafter. The current ESSER reporting form is available for review
through: https://api.covid-relief-data.ed.gov/collection/api/v1/public/
docs/ESSER_Data_Collection_Final.pdf.
The Department acknowledges the importance of collecting and
publicly reporting information on school districts' financial
commitments (obligations), as well as outlays in order to more
completely reflect the status of their use of Federal COVID-19 relief
funds. Earlier this year, the Department proposed modifications to its
ESSER annual report on State and school district spending data to
include obligations data in subsequent reporting cycles. The proposed
modifications, in accordance with the Paperwork Reduction Act, are
currently available for public comment on the Federal Register:
(https://www.Federalregister.gov/documents/2021/07/02/2021-14200/
agency-information-collection-activities-comment-request-education-
stabilization-fund-elementary-and).
Question. The Department's fiscal year 2022 Annual Performance Plan
includes plans to identify opportunities to further build and use
evidence in both formula and competitive grant programs.
How many competitive grant programs will include an evidence
priority in fiscal year 2021?
Answer. In fiscal year 2021, 19 competitions required the use of
evidence through a requirement or an absolute priority and 6
competitions included a competitive priority for evidence, and 18
encouraged applicants to rely on evidence by including it in selection
criteria. An additional 2 competitions encouraged the use of evidence,
such as through an invitational priority. Note that two competitions
included evidence in more than one way and are thus counted in multiple
categories. An unduplicated total of 43 competitions, or almost 60
percent of all competitions in fiscal year 2021, included evidence in
at least one of these ways.
Question. How many competitive grant programs does the Department
plan to include an evidence priority in fiscal year 2022?
Answer. The Department is discussing how best to use and build
evidence in fiscal year 2022 competitions in alignment with statutory
requirements, the body of available evidence, and lessons learned from
previous competitions.
Question. Please identify the formula programs in which evidence
building and use will be promoted and supported and the specific
strategies to accomplish these goals.
Answer. The Department is supporting evidence building and use in
the ESEA formula grant programs under Titles I, II, and IV. Evidence is
also important within the context of IDEA formula grant programs. The
Department works with the Comprehensive Centers, the Regional
Educational Laboratories, and the technical assistance centers funded
by the Office of Special Education programs to identify and share
resources related to evidence building and use. To further support the
identification of evidence-based practices, The Institute of Education
Sciences' What Works Clearinghouse has recently added a new feature to
its website--evidence tier ``badges''--making it easier for users to
know whether a given approach meets regulatory definitions of strong,
moderate, or promising evidence. The WWC has also produced a series of
technical assistance materials supporting the use of this feature and
of the site overall. In addition, the Department is providing resources
related to the evidence-based strategies required under the Elementary
and Secondary School Education Relief Fund (ESSER Fund) under the
American Rescue Plan. Within the context of safely reopening all
schools, the Department has created the Safer Schools and Campuses Best
Practices Clearinghouse. The Clearinghouse provides resources for
practices that can be leading examples of how best to provide support
to students and educators.
Question. Please describe efforts the Department has undertaken to
build the internal capacity of staff in the use and implementation of
evidence in activities funded through formula and competitive grant
programs.
Answer. Measuring Skills. In 2020, ED developed and fielded the
inaugural Data and Evidence Use Survey to measure staff skills. In Q3,
the Office of the Chief Data Officer and the National Center for
Educational Evaluation finalized the survey to respond to requirements
of the Evidence Act and the Federal Data Strategy. CDOs in other
agencies, including DHS, Commerce, Labor, and the Air Force have
requested and received ED's survey to support their efforts. The
results of the ED Survey are used to target staff training to improve
data literacy and the capacity to use evidence.
The Evidence Act requires ED to assess its evaluation activities
and agency capacity to support the development and use of evaluation.
Congress explicitly made this requirement an agency-wide focus by
instructing the Evaluation Officer to coordinate activities with agency
officials in carrying out the functions of the Evaluation Officer in
section 313(d) of title 5. Additionally, the Open Government Data Act
requires the Chief Data Officer to support the Evaluation Officer in
identifying and using data to carry out their statutory functions
(Sec. 3520(c)(9)). The Evaluation Officer and the Chief Data Officer
share common interest and authority in carrying out these functions and
collaborate to field the annual Data and Evidence Use Survey.
Enhancing Skills. In 2021 ED launched its new Data Literacy
Program, an intentional commitment to upskilling and continual
learning. The program's goal is to develop a data culture at ED which
enables all staff to speak a shared language around data and evidence.
An expert-based approach was designed with support from The Data Lodge
to provide a comprehensive corpus of flexible training to reach 3,500
staff. A partnership among ED's data office, research office, and human
resources office resulted in a committee of 5 SES and GS15 leaders
(including ED's Evaluation Officer) who developed the program
blueprint. The blueprint mapped out a programmatic approach over 3
years, engaging ED offices in waves of customized, highly interactive
sessions. Learning pathways were developed using Skillsoft. ED also
developed plans for its own developed content and OCDO-led introductory
workshops. Current training consists of four major components: (1) a
hallmark initial, interactive 2-hour session ``Exploring Data
Literacy,'' (2) a one-hour ED-specific session, ``Data Literacy 101''
(3) four self-paced Learning Pathways of SkillSoft and external courses
around evidence, decisionmaking, visualization, and analytics and (4)
Learning Bytes, 15 min interactive topics recorded for easy use.
As ED staff begin to build data literacy, we continue our efforts
to ensure that all staff are increasingly well-versed in the role of
evidence in the work of schools, States, districts, and institutions of
higher education. This past year, the Institute of Education Sciences
and the Office of Planning, Evaluation, and Policy Development's Grants
Policy Office (GPO) began offering ``Evidence 101: Evidence Use at the
Department of Education'' to all new hires each quarter. As part of
that training, new staff are introduced to statutory and regulatory
requirements related to evidence use, the history of evidence use at
the Department, and Department resources that can support their work.
IES and GPO have also worked to build a virtual ``community of
practice'' focused on evidence use based on a monthly newsletter to
staff and associated website, the Evidence Connection. Approximately
250 staff across the Department are currently members and receive
regular updates about resources that can support their efforts to use
evidence in their own work and support the work of Department grantees.
Question. What is the Department's plan for continuing to build
this capacity in the coming year?
Answer. In 2022, the ED Data Literacy Program will advance general
staff ability to use, understand, and apply data and evidence to
support decisionmaking around programs, policy, and operations. In
2022, the program will mature current engagement, curriculum, and
resources. First, our engagement will broaden and deepen. Current Data
Literacy Ambassadors for the first wave of ED offices participating in
the program will customize and deliver existing program resources for
relevant and actionable professional development. We will onboard
additional offices to reach all 3,500 staff. Second, we will expand our
current curriculum and add new courses, both interactive and virtual,
asynchronous training. In 2022, we would like to add 4 major ED-
specific courses featuring ED leaders, data processes, core data
collections, and projects and tools. Lastly, we plan to augment and
enhance resources around data language (e.g., Glossary), expertise
(e.g., Directory) best practices and technology. To address the
specific capacity-building needs of ED data professionals who support
the production of evidence for grant programs, ED launched its new Data
Professionals Community of Practice (DPCoP) in August 2021. In
alignment with ED Data Strategy Objective 2.3 ``Establish clear career
paths and training curriculums for data professionals'', the DPCoP will
be a member-driven collaborative forum open to all ED data
professionals. It will provide opportunities to share resources, tools,
and successful practices in ED, inform leadership of data-related
issues or concerns, and establish workgroups to address specific topics
and challenges.
Question. How will the Department measure the growth of this
capacity and expected improved targeting of resources to activities
authorized by current law and aligned with evidence of effectiveness?
Answer. Evidence Use. As noted above, the Department is currently
fielding the second iteration of its Data and Evidence Use Survey. The
survey provides repeated cross-sectional estimates of ED staff capacity
to use evidence in their work in areas including: (1) designing
performance measures, (2) providing technical assistance on evidence
definitions and requirements, and (3) monitoring grantees for effective
evidence use. These data can be used to inform professional development
opportunities for ED staff and the production of new resources for both
staff and stakeholder use.
Resource Targeting. The Department will continue to work with SEAs,
LEAs, institutions of higher education and other entities to support
and increase the use of evidence to inform decisionmaking.
Question. How does the Department support and monitor SEA and LEA
decisionmaking related to reasonably available determinations for
evidence use under provisions of ESEA? What are the Department's plan
to monitor and further support such determinations?
Answer. To support States, local educational agencies (LEAs), and
schools in understanding the levels of evidence and interventions that
meet them, the Department continues to disseminate information and
provide technical assistance that highlights the evidence levels
associated with a wide range of interventions, strategies, and
approaches. Specifically, the Institute of Education Sciences What
Works Clearinghouse (WWC) provides information on the evidence levels
of interventions, strategies, and approaches on a wide range of topics
through both Intervention Reports and Practices Guides, as well as
individual studies. These user-friendly resources describe the level of
evidence demonstrated, the characteristics of students, and the setting
(urban, rural, suburban) of the research studies included. When
evaluations produced through discretionary grant programs are submitted
to the WWC for review to determine if they meet the evidence levels as
defined in the ESSA, they can be highlighted in the WWC for use in
supporting formula grantees. In addition, the Department's technical
assistance network also produces resources to support their respective
target audiences in understanding and using evidence. For example, this
resource from the Regional Education Laboratory West provides important
considerations for using evidence-based interventions.
With respect to monitoring use of evidence consistent with
statutory and regulatory requirements, the Department includes
questions regarding State and local compliance with evidence
requirements as relevant in its monitoring protocols. In addition to
understanding compliance with these requirements, these monitoring
protocol questions allow program officers to identify areas for future
technical assistance to support States, LEAs, and schools in their
efforts to support student achievement.
Question. Last year, Congress removed a limitation on Federal
education funds that prevented the use of such funds for transportation
costs associated with school integration efforts.
How will the Department and its technical assistance providers work
with state educational agencies (SEAs), local educational agencies
(LEAs) and schools to inform and support them in this use of funds?
Answer. While Congress has removed certain limitations on the use
of Federal education funds for transportation costs related to school
integration plans, section 8526(2) of the Elementary and Secondary
Education Act of 1965 (ESEA; 20 U.S.C. 7906(2)) prohibits ESEA funds
from being used for transportation unless otherwise authorized by the
ESEA. Most ESEA programs, including Title I Grants to LEAs and Title
IV-A Student Support and Academic Enrichment Grants, do not authorize
the use of funds to transport students to or from the regular school
day.
In addition, section 802 of the Education Amendments of 1972 (20
U.S.C. 1652), titled ``Prohibition against busing'' includes a
restriction for the use of funds under ED programs for the
transportation of students or teachers to carry out a plan of racial
desegregation of any school system, subject to certain contingencies.
Question. The previous administration failed to hire sufficient
staff at the Office for Civil Rights, despite increases in
appropriations and direction to do so.
Please describe the impact of each staff member having such a large
caseload on their ability to thoroughly investigate complaints for
associated evidence of systemic discrimination, timely process
complaints, conduct compliance reviews, and monitor corrective actions.
Answer. A critical component of OCR's mission is the prompt
investigation and resolution of complaints. A large per-staff caseload
hinders OCR's ability to discharge this responsibility in a timely
manner, which is also unacceptable to both complainants and recipients.
OCR enforcement staff are required to conduct investigations and make
determinations that are factually accurate and legally sound. Ensuring
that these standards are met is a process that requires careful
consideration of evidence provided by complainants and recipients.
There are no ``short cuts'' to fulfilling OCR's mission. Current
caseload numbers may impact OCR's ability to pursue proactive
enforcement activities--compliance reviews and directed
investigations--as well as effectively address an anticipated increase
in complaints. In short, large caseloads can slow the delivery of
justice for complainants and disserve school districts and
postsecondary institutions that need guidance from the Department to
ensure that they provide all students with an environment that is free
from discrimination.
Question. How would the additional staff requested in the budget be
utilized to enable OCR to more effectively fulfill its mission?
Answer. The majority of the additional staff will be utilized to
resolve complaints and proactive activities (compliance reviews and
directed investigations). OCR also requested additional legal staff
that will develop policy guidance and regulatory materials for civil
rights enforcement. Additional administrative staff will respond to
Freedom of Information Act (FOIA) requests and help reduce the FOIA
backlog and support Civil Rights Data Collection. Requested
administrative staff are also needed to provide oversight of OCR's IT
security, systems operations, website and records management.
Question. With respect to the Charter School Grants program, the
fiscal year 2022 Congressional Justification indicates: ``The
Department will work to ensure that Charter Schools Grants funds
support schools that are opened and operated with demonstrated family
and community support, serve students from diverse racial and
socioeconomic backgrounds, provide meaningful access to instruction for
students with disabilities and English learners, maintain diverse
educator workforces, and are subject to strong accountability,
transparency, and oversight.'' The document also indicates that 14
state entity grantees provide or plan to provide technical assistance
to charter school subgrantees in meeting the needs of students with
disabilities, while 13 provide or plan to provide technical assistance
to subgrantees in meeting the needs of English learners.
Please describe how the Department will accomplish each of the
objectives outlined above.
Answer. The Department looks forward to working with you and with
other stakeholders to address these important priorities.
Question. What does the Department know about the evidence base
supporting the state entity technical assistance strategies for
students with disabilities and English learners? With which tier, if
any, of the definition in section 8101(21)(A) of the Elementary and
Secondary Education Act (ESEA) do they align?
Answer. The program statue does not require applicants to propose
evidence-based technical assistance strategies, as such, information
regarding the evidence base for specific state entity (SE) technical
assistance strategies implemented by SE grantees to support students
with disabilities and English learners was not examined as part of the
review referenced in the program's Congressional Justification.
Question. Please describe how the Department would use national
activities funds available in fiscal year 2022 or supported by fiscal
year 2022 appropriations for each of the national activities
authorities available under the ESEA.
How would these plans be informed by evidence of effectiveness and
the needs of those served by each of the authorities?
Answer. The Department does not yet have detailed plans for
national activities in fiscal year 2022, since most planning for
discretionary grant programs, including national activities
authorities, takes place in the summer and fall prior to the beginning
of the fiscal year. In addition, such plans depend in part on
completion of final appropriations action, which includes both final
funding levels and any applicable Congressional priorities for the use
of national activities funds. Consideration of the needs of those
served by our programs, as well as maximizing the use of evidence-based
practices in meeting those needs, is the starting point for the
Department's planning process.
Question. Under the Every Student Succeeds Act, SEAs and LEAs were
required to develop plans for how they will identify and address the
disparities of low-income and minority children being
disproportionately taught by ineffective or inexperienced teachers.
How does the Department plan to support the timely implementation
of such plans, including through the use of funds appropriated and
requested for Title II-A of ESEA and other current law authorities?
Answer. ESEA section 1111(g)(1)(B) requires each SEA to describe
how low-income and minority children enrolled in Title I, Part A
schools are not served at disproportionate rates by ineffective, out-
of-field, or inexperienced teachers, and the measures the SEA will use
to evaluate and publicly report the progress of the SEA with respect to
such description. Consistent with ESEA section 8302, the Department
determined that this description was required as part of the
consolidated State plan. Thus, each SEA was required to provide a
description and how it will publicly report its progress in addressing
any identified disparities. This provision does not require each SEA to
submit a plan to the Department regarding how it will address those
disparities. Information about the ESSA Consolidated State Plan,
including each State's plan, can be found at: https://oese.ed.gov/
offices/office-of-formula-grants/school-support-and-accountability/
essa-consolidated-state-plans/.
The Department includes a review of this requirement in our
monitoring protocols for Title I, Part A (available at: https://
oese.ed.gov/files/2020/08/SEA-Protocol-Title-I.docx). The Department
requires each SEA monitored to describe how it evaluated its progress
toward ensuring that low-income and minority children in Title I
schools are not served at disproportionate rates by ineffective, out-
of-field, and inexperienced teachers and requests updated educator
equity data. The Department also requires each SEA to describe how it
publicly reported its progress toward meeting this requirement and asks
for documentation of public reporting. Finally, the Department asks
each SEA to describe how it supports LEAs in meeting this requirement.
The SEA must describe how it ensures each LEA receiving a Title I, Part
A subgrant identifies and addresses disparities resulting in low-income
and minority students having disproportionate access to ineffective,
out-of-field, and inexperienced teachers and requests that the SEA
provide the following documentation, if applicable: LEA plan template
reflecting this requirement; SEA guidance for LEAs related to equitable
access to educators; and/or SEA monitoring protocol that demonstrates
the SEA is verifying compliance with this requirement.
In our review of States over the past several years, the Department
has issued two monitoring findings related to these requirements. In
2020, the Department cited Kentucky for two issues: 1) the State
publicly reported inaccurate educator equity data; and 2) the State did
not adequately document how it ensures that each LEA receiving a Title
I subgrant identifies and addresses disparities resulting in low-income
and minority students having disproportionate access to ineffective,
out-of-field, and inexperienced teachers. In 2019, the Department
issued a finding for New Jersey because although the State provides
LEAs with multiple sources of related data, NJDOE is not currently
evaluating or publicly reporting its progress in ensuring that low-
income and minority children in Title I, Part A schools are not served
at disproportionate rates by ineffective, inexperienced, and out-of-
field teachers. The Department also issued a recommendation that New
Jersey incorporate the requirement in ESEA section 1112(b)(2) in the
State's subrecipient monitoring protocol to ensure that LEAs are
meeting the statutory requirements to ensure that low-income and
minority children in Title I, Part A schools are not served at
disproportionate rates by ineffective, inexperienced, and out-of-field
teachers. The reports for Kentucky and New Jersey (and all information
related to the Department's consolidated monitoring, can be found at:
https://oese.ed.gov/offices/office-of-formula-grants/school-support-
and-accountability/performance-review/).
Regarding the use of Title II, Part A funds, the ESEA consolidated
State plan asks each State to describe how it will use Title II, Part A
funds to address this requirement, if it chooses to do so. In addition,
the Department conducts an annual use-of-funds survey that asks SEAs to
account for how State-level Title II, Part A funds are used. In school
year (SY) 2019-2020, the most recent year for which survey data are
available, 20 States indicated that they had spent at least some of
their State-level Title II, Part A funds on activities to improve
equitable access to effective teachers. The Department also conducts an
annual survey on how LEA-level Title II, Part A funds are used; this
survey is distributed to a nationally- and State-level-representative
sample of LEAs in the country. In the survey covering expenditures in
SY 2029-2020, 34 percent of responding LEAs indicated that they had
spent at least some of their Title II, Part A funds on strategies to
recruit, hire, and retain effective educators, although it is not clear
if these expenditures specifically focused on ensuring equitable access
effective educators in the districts. Additional detail on the results
of the 2019-2020 surveys on how Title II, Part A funds were used is
available at https://ies.ed.gov/ncee/pubs/2021011/index.asp.
The Department looks forward to expanding and building upon these
efforts.
Question. Analysis of CDC data and other reports indicate a
reduction in routinely recommended vaccination of children and youth
last year resulting from the disruption to routine healthcare caused by
the COVID-19 pandemic. Lack of proper vaccinations could provide an
additional challenge to the return to in-person learning in the fall.
How is the Department working with HHS to support the vaccination
of children and youth needed for school enrollment for in-person
learning?
Answer. The Department is working to support HHS/CDC in the
dissemination of guidance on vaccination of children and youth in the
following manner:
--Collaborated and hosted a number of webinars to share mitigation
strategies and guidance with the educators, school personnel,
families, education stakeholders, and public
--Participated in bi-weekly ED/CDC planning calls to coordinate and
organize scheduled webinars with HHS/CDC and the Department
--Posted resource materials on the Department of Education website,
federally supported National Technical Assistance websites, as
well the newly launched Safer Schools and Campuses Best
Practices Clearinghouse (https://
Bestpracticesclearinghouse.ed.gov)
--Participated in weekly established ED/CDC K-12 Touchbase calls to
share information/research/guidance/upcoming agency planned
activities
--Released Guidance Handbooks for the education community and
included information on the topic
Question. The Department is developing supplemental priorities that
may be applied to fiscal year 2022 and future grant competitions. The
fiscal year 2022 Congressional Justification cites building and
enhancing the instructional skills of a more diverse educator workforce
as one possible supplemental priority.
What other supplemental priorities may be applied in fiscal year
2022 competitions?
Answer. The Department published a Notice of Proposed Priorities on
June 30, 2021. There are six draft priorities: (1) Addressing the
Impact of COVID-19 on Students, Educators, and Faculty; (2) Promoting
Equity in Student Access to Educational Resources, Opportunities, and
Welcoming Environments; (3) Supporting a Diverse Educator Workforce and
Professional Growth to Strengthen Student Learning; (4) Meeting Student
Social, Emotional, and Academic Needs; (5) Increasing Postsecondary
Education Access, Affordability, Completion, and Post-Enrollment
Success; and (6) Strengthening Cross-Agency Coordination and Community
Engagement to Advance Systemic Change.
Question. Please identify the programs in which supplemental
priorities will be applied.
Answer. The public comment period on the Notice of Proposed
Priorities closed on July 30. The Department is reviewing the comments
received and is considering how best to incorporate the Secretary's
priorities in fiscal year 2022 competitions once the priorities are
finalized.
Question. The budget includes $180 million, an increase of $15
million more than the fiscal year 2021 LHHS bill, for the National
Assessment of Educational Progress (NAEP). The requested funds would
maintain the current assessment schedule and provide funding for
initial research and development investments intended to improve
assessment quality and reduce future program costs. Over the past year,
staff of the Department, National Center for Education Sciences and
National Assessment Governing Board have provided informative updates
on COVID-19-induced changes to the NAEP schedule and cost increases.
Please provide:
A description of the policies and procedures implemented to ensure
sufficient oversight and monitoring of contracts, including cost
controls.
Answer. All Institute of Education Sciences (IES) acquisition
activities, including NAEP, adhere to the Department's internal control
strategies, policies, and procedures, with support from the
Department's Contracts and Acquisition Management (CAM) team and Budget
Service:
--Budget Service reviews every planned and on-going contract over
$100k. The Budget Service team reviews, approves, and allots
funds in the Department's payment management system before
funds can be obligated to support payments to vendors (by CAM).
--CAM ensures that new and current contracts are legal and consistent
with the Federal Acquisition Regulations (FAR). Contracting
Officers (who possess warrants to sign off on new acquisitions
and day-to-day commitments) independently review every invoice
submitted by vendors before payment to ensure that costs are
allowable. CAM also partners with IES to validate that FAR
requirements are maintained across the lifecycle of every
individual Assessment contract.
In the Department's most recent A-123 internal control entity level
review of IES, completed in Fall 2020, IES (including the Assessment
Division) provided evidence that IES meets and effectively implements
all 17 GAO Green Book principal areas across all five GAO Internal
Control component areas. IES recognizes that we need to do more to
better anticipate the challenges of increased cost and uncertainties
related to our assessment activities and unforeseeable events such as
COVID-19.
IES recently established an Acquisition Program Management Office
(PMO) that is focused on modernizing IES acquisition practices to
better align with our business model and improve outcomes for
customers. IES also recently awarded a small contract to conduct an
independent validation and review of our current controls and funds
management practices for the Assessment program. We initiated this
contract in part due to the rising costs of assessments, reflected in
the 2019 NAEP Alliance contracts, and in part due to the recent volume
of unplanned and unforeseen task revisions and cost adjustments within
the NAEP Alliance contracts resulting directly from COVID-19. We expect
the results of this quick-turnaround review at some point early in the
2022 calendar year.
Question. The amount and descriptions of additional funding needed
in each of fiscal year 2022, fiscal year 2023 and fiscal year 2024 for
research and development investments;
Answer. The requested $15 million increase would support NAEP
operations to fiscal year 24 and beyond for the current assessment
schedule and would begin to support necessary R&D investments. However,
we anticipate that additional investments would be needed in future
years both to maintain NAEP as the gold standard of large-scale
assessments and to produce cost savings and efficiencies in program
administration costs over time (see responses to 1d and e below).
We also note that while this response is based on the most accurate
budgetary estimates currently available, there may be adjustments to
these estimates based on additional modifications to NAEP alliance
contracts in response to the impact of COVID-19 on NAEP activities.
Estimated Allocations to Operations and R&D based on increase of
$15 million per year (as of 8.4.21)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Funding stream FY22 FY23 FY24 FY25 FY26 FY27 FY28 approp
--------------------------------------------------------------------------------------------------------------------------------------------------------
Operational..................................................... $14M $10M $12M $12M $12M $12M $12M $84M
Current R&D\*\.................................................. $1M $5M $3M $3M $3M $3M $3M $21M
Total....................................................... $15M $15M $15M $15M $15M $15M $15M $105M
--------------------------------------------------------------------------------------------------------------------------------------------------------
\*\See response to question 1d below for current R&D activities.
Question. The amount of additional funding needed in each of fiscal
year 2022, fiscal year 2023 and fiscal year 2024 for operating costs;
Answer. Please see the response to 1b. above. Based on the best
estimates available at this time, the requested $15 million increase
would support operational funding needs through fiscal year 2024;
however, as noted above, it may not fully support currently planned R&D
efforts.
Question. Studies planned and other actions necessary for
maintaining the continuity and integrity of NAEP in any changes
implemented to reduce future program costs;
Answer. We have a number of actions planned to achieve
efficiencies, starting in 2022. These include (i) transitioning to
online assessments, (ii) transitioning from Surface Pro tablets to more
cost-efficient devices in the short term and to school-owned devices in
the longer term, (iii) introducing automated scoring, (iv) reducing the
number of field staff needed to conduct the assessments, and (v)
implementing design changes, including adaptive testing and two-subject
design. Each change will be carefully studied in multiple rounds of
reviews to first explore feasibility and examine effect(s), if any, on
student performance. If any effect on student performance is detected,
IES will need to implement a bridge study to account for the effect and
maintain trends.
Question. Expected savings and supporting information by fiscal
year associated with research and development investments for reducing
future program costs; and
Answer. We expect to realize savings beginning in fiscal year 2024
as currently funded R&D efforts in automated scoring and the eNAEP test
platform take effect. These savings, which are measured against
estimated costs on the current NAEP platform in the absence of proposed
R&D-based modernization efforts, will grow through fiscal year 2030
assuming IES is able to implement fully its planned R&D investments on
eNAEP, which would enable NAEP to be administered on less costly
devices, including school equipment (device agnostic), and with reduced
NAEP field staff. We also note that the capacity to test individual
students in multiple subjects using such devices should dramatically
reduce student and school sample sizes, yielding further savings.
Estimated savings by two-year NAEP cycle are in the table below. Total
expected savings associated with current (and planned future R&D)
investments over the period are approximately $98 million. Note that
these estimated savings assume increased R&D funding in future years.
------------------------------------------------------------------------
Expected
Two-year cycle Savings
------------------------------------------------------------------------
FY23--24..................................................... $4M
FY25--26..................................................... $20M
FY27--28..................................................... $42M
FY29--30..................................................... $32M
Total.................................................... $98M
------------------------------------------------------------------------
Question. Potential additional reductions to future program costs
or program enhancements resulting from recommendations made under
current contract with National Academies of Sciences, Engineering, and
Medicine.
Answer. An independent expert panel convened by the National
Academies of Sciences, Engineering, and Medicine (NASEM) is currently
underway. This 17-month study focuses on how NAEP might modernize its
operations and reduce costs through innovations such as those mentioned
in (d) above. We expect that NASEM's recommendations, once released in
February 2022, will help further refine current plans for
modernization. Some of the innovations under consideration by NASEM are
not expected to result in cost savings (e.g., adaptive testing), but
could improve measurement quality, especially for students scoring at
below NAEP Basic level.
Question. The current NAEP assessment schedule outlines plans to
conduct the Long-Term Trend (LTT) assessment for 17 year-olds in 2022
as a result of the delay caused by the COVID-19 pandemic. However, also
repeating the LTT for 9-year-olds in 2022 would provide nationally
representative information on the impact of COVID-19 on reading and
math learning, including for students of color. This kind of
information would be one type of information and research on learning
loss intended to be funded by the $100 million provided to the
Institute of Education Science by the ARP.
Will the assessment schedule be changed to collect this important
information?
Answer. Yes. NCES and NAGB agreed that the NAEP schedule should be
changed to collect this important information for age 9-year-olds in
2022, while canceling the LTT for 17-year-olds. NAGB will take an
official vote on the change to the schedule at the August meeting.
Additionally, preparation for both LTT age 9 and age 17 would be
unsustainably expensive given available funding and the expected $8m
cost for each of these age groups. That is, preparation for paper
booklets, quality control reviews, printing, and distribution could not
be done for both cohorts given anticipated budget shortfalls in 2024.
Accordingly, we put preparations for LTT age 17 on hold in June based
largely on cost considerations. NCES has also confirmed that it is too
late to restart preparation work for age 17, even if funds were made
available.
Question. If the LTT for nine year olds was not paid for with funds
available to IES in the ARP, how would such a change impact the NAEP
2021 operating plan? How would such an additional cost for LTT impact
the rest of the currently approved assessment schedule? Please provide
a revised operating plan.
Answer. The Department considered using ARP funds for LTT but
decided against doing so because of legal concerns with using ARP funds
for research. Regarding the impact on the NAEP budget, since the data
collection costs for the two cohorts are comparable, changing from an
assessment of 17-year-olds to 9-year-olds would have no real effect on
anticipated outlays. The anticipated shortfall in 2024 would remain the
same if the requested $15 million increase in fiscal year 2022 is not
enacted.
We note that in 2025 the schedule calls for all three ages, 9, 13,
and 17 to be collected again as part of a bridge study to transition
the assessments from paper to digital formats.
Question. ESEA contains provisions on parent and family engagement
under ESEA programs and authorizes support for Statewide Family
Engagement Centers. These ESEA provisions include a 1 percent set-aside
of LEA Title I-A allocations for effective parent and family engagement
activities, along with requirements for parent, family and community
engagement activities using English Language Acquisition funds.
What are the Department's plans for supporting SEAs and LEAs in
implementing parent and family engagement requirements under section
1116 of ESEA, including in identifying and overcoming barriers to
greater participation by parents who have limited English proficiency
or are of any racial or ethnic minority background?
Answer. The Department administers the Statewide Family Engagement
Centers program which is authorized under Title IV, Part E of the
Elementary and Secondary Education Act of 1965, as amended. The purpose
of the SFEC program is to provide financial support to organizations
that provide technical assistance and training to SEAs and local
educational agencies LEAs in the implementation and enhancement of
systemic and effective family engagement policies, programs, and
activities that lead to improvements in student development and
academic achievement. For those families from diverse background and
who have limited English proficiency, there are 12 statewide family
engagement centers across the country that (1) carry out parent
education and family engagement in education, programs and (2) provide
comprehensive training and technical assistance to SEAs, LEAs, schools
identified by SEAs and LEAs, organizations that support family-school
partnerships and other such programs.
In addition, the Department administers the Comprehensive Centers
program, which is authorized under Title II, Sec. 203, of the
Educational Technical Assistance Act of 2002. The Comprehensive Centers
address needs identified by SEAs in meeting ESEA student achievement
goals, as well as priorities established by states. As part of this
work, Comprehensive Centers have developed resources on various topics
(e.g., literacy instruction) to support SEAs, LEAs, and educators.
Building SEA and LEA capacity to engage parents and families is a key
element of this support (e.g., Evidence Based Literacy Instruction:
Families as Partners). Comprehensive Centers have also developed
resources that specifically focus on establishing and nurturing
successful school-family relationships. Finally, parent and family
engagement has played an important role in the Summer Learning and
Enrichment Collaborative (SLEC). Several SLEC sessions have provided
SEAs, LEAs, and other participants with support on developing
partnerships for family engagement in high-needs communities, creating
authentic partnerships with marginalized families and communities, and
meeting whole student and family needs through collaborative
partnerships at school.
The Department looks forward to expanding and building upon these
efforts.
Question. How does the Department monitor and support the
coordination and integration of parent and family engagement strategies
under Title I-A with other relevant Federal programs?
Answer. Under ESEA section 1116, an LEA receiving Title I, Part A
funds must develop a written parent and family engagement policy in
collaboration with parents and family members of participating
students. Among other things, the policy must describe how, to the
extent feasible, the agency will coordinate and integrate Title I
parent and family engagement strategies with strategies under other
relevant Federal, State, and local laws and programs. An LEA's policy
also must describe how it will annually evaluate of the content and
effectiveness of the parent and family engagement policy, including
identifying barriers to participation, with particular attention to
parents who are economically disadvantaged, disabled, have limited
English proficiency, have limited literacy, or are of any racial or
ethnic minority background. The Department monitors ESEA section 1116,
Parent and Family Engagement, as part of the Title I, Part A monitoring
protocol (available at: https://oese.ed.gov/files/2020/08/SEA-Protocol-
Title-I.docx). Within the protocols, the Department specifically asks
each SEA it monitors to describe how it reviews LEA parent and family
engagement policies and practices to ensure the LEA meets the
requirements of section 1116, including those referenced above. In
addition, the Department asks each SEA to describe how, in its review
of the LEA's parent and family engagement policies and practices, it
ensures that the LEA's parent and family engagement policies provides
opportunities for the participation of all parents and family members
(including parents and family members who have limited English
proficiency, parents and family members with disabilities, and parents
and family members of migratory children) and provides information and
school reports, in a format and, to the extent practicable, in a
language that parents understand. The Department asks that each SEA
submit its process to review LEA policies and procedures for family
engagement as evidence during the monitoring review.
Additionally, the Department of Education has an Office of
Communications and Outreach that has a Family and Community Engagement
Team. The goal of the Team is to expand efforts to help schools,
districts, and states better engage families in education. This team
works to monitor and support the coordination and integration of parent
and family engagements strategies under Title I, Part A (and other
Titles) with other relevant Federal programs.
Question. The fiscal year 2022 Annual Performance Plan identifies a
goal of improving access to quality educational programs in
correctional settings.
Please identify the programs and strategies involved in improving
access to quality educational programs in correctional settings.
Answer. The Office of Career, Technical, and Adult Education's
Integrated Education and Training (IET) in Corrections Project will
identify, develop, and document IET in corrections models to
demonstrate how to extend existing secondary-postsecondary pathway
models to include the corrections system. The project is intended to
provide strategies that can be disseminated and replicated.
Second Chance Pell (an Experimental Site Initiative) launched in
2016 and allowed 67 colleges and universities enroll incarcerated
students using Pell Grants on an experimental basis. In 2020, the
program was expanded to allow an additional 67 colleges and
universities to serve even more students. On July 30, 2021, the
Department announced a further expansion of Second Chance Pell to gain
critical insights about how to reinstate Pell Grant eligibility within
correctional facilities, consistent with the implementation of the
provisions of the Consolidated Appropriations Act of 2021 that will
expand Pell Grant eligibility for all eligible incarcerated students on
July 1, 2023. The Department has announced plans to publish regulations
on the program prior to its implementation and held public hearings in
June of 2021 to that end.
The Department has already taken steps to implement changes to the
Free Application for Federal Student Aid (FAFSA), which incarcerated
students and education institutions alike have reported as a major
stumbling block in implementing college-in-prison programming. For
example, for the 2021-2022 award year FAFSA, the Department has removed
the impact of responses to questions about Selective Service
registration and requirements around drug convictions. These questions
will be removed entirely from future FAFSAs.
Question. How will the Department work with relevant Federal
agencies on this goal?
Answer. The Department currently staffs interagency working groups
including the Federal Advisory Committee on Juvenile Justice, the Legal
Aid Interagency Roundtable, and the Interagency Working Group for Youth
Programs. The Department liaises on a regular basis with other Federal
agencies including the Departments of Justice, Labor, Health and Human
Services, and the Consumer Financial Protection Bureau to update these
agencies on Departmental initiatives, such as Pell reinstatement, that
are focused on quality educational program in correctional settings.
The Department also works collaboratively with these agencies as they
implement programming for incarcerated.
Question. CRDC data from the 2017-18 school year survey show that
Black students represented 15 percent of student enrollment but 38
percent of students who received one or more out-of-school suspensions.
Such discipline contributes to lost instructional time and negative
life outcomes.
Please describe planned activities for how the Department will
support a reduction in racial disparities in school discipline.
Answer. The Department is aware of these and other disparities in
the administration of school discipline nationwide--and the adverse
impacts that these disparities have on students--and is actively
planning to address these issues. The Department anticipates issuing
new guidance following its 2018 rescission of the Dear Colleague letter
on Nondiscriminatory Administration of School Discipline and related
materials, which provided guidance to schools on how to identify,
avoid, and remedy discrimination based on race, color, or national
origin in the design and administration of school discipline and create
a positive school climate. As part of that process, on May 11, 2021,
the Department's Office for Civil Rights (OCR) and the Civil Rights
Division of the U.S. Department of Justice organized a virtual
convening session, Brown 67 Years Later: Examining Disparities in
School Discipline and the Pursuit of Safe and Inclusive Schools, where
students, educators, school administrators, civil rights lawyers, and
researchers considered the impact of exclusionary school discipline
policies and practices on our nation's students, particularly students
of color, students with disabilities, and LGBTQ+ students. As a follow
up to the convening, on June 8, 2021, OCR published a Request for
Information (RFI), seeking public comments on what guidance schools and
school districts need to ensure all students attend welcoming,
supportive, and safe schools. As stated in the RFI, OCR recognizes that
students may experience multiple forms of discrimination at once and
encourages commenters to identify and address individual and
intersectional discrimination as appropriate. OCR expects that the
public comments in response to the RFI will inform future decisions
about what policy guidance, technical assistance, or other resources
would assist schools that serve students in pre-K through grade 12 with
designing and administering school discipline in a nondiscriminatory
manner and improving school climate and safety. The comment period for
the RFI closed on July 23, 2021, and OCR is in the process of reviewing
the comments received.
Question. The fiscal year 2022 President's budget proposes to
continue authority for performance partnership pilot and proposes a
priority for such pilots to include communities disproportionately
impacted by COVID-19.
What are the Department's plans for inviting new applications for
performance partnership pilots?
How will these pilots be informed by the national evaluation
released earlier this year, including the recommendations for more
planning time, additional guidance and technical assistance, and
support of systems change through developing and implementing related
metrics?
Answer. The Department, as part of the ongoing Administration
transition, is continuing to evaluate the lessons learned from previous
Performance Partnership Pilots for Disconnected Youth (P3), including
recommendations from the national evaluation, and how best to position
the program for maximum impact in the context of State and local needs
arising from the COVID-19 pandemic (including any flexibilities that
could facilitate more effective use of ARP funds), as well as other
Administration priorities.
Question. The ``Foundations for Evidence-Based Policymaking Act of
2018'' includes key provisions related to developing a multi-year
learning agenda, evaluation plan, improving coordination of data
government at the Department, and improving accessibility of education
data.
What is the Department's timeline for release of its multi-year
learning agenda? Please describe stakeholder consultations that have
occurred or will occur during its development.
Answer. Per OMB guidance, the Department will publish its multi-
year Learning Agenda for fiscal year 22-26 in February 2022, concurrent
with the release of the President's fiscal year 2023 Budget.
Consultation with stakeholders will include a broad Request for
Information published in the Federal Register, along with targeted
outreach to specific communities based on their role (e.g., chief state
school officers) or area of emphasis (e.g., researchers focused on, or
advocacy organizations related to, Federal student aid).
Question. When will the Department release its evaluation plan?
Answer. Per OMB guidance, the Department will publish its fiscal
year 2023 Annual Evaluation Plan in February 2022, concurrent with the
release of the Presidents' fiscal year 2023 Budget. The Department's
fiscal year 22 Annual Evaluation Plan, which was delayed so that
elements of the document could be better aligned to the Secretary's
priorities and the Department's strategic planning efforts, will be
posted in August 2021 to https://ed.gov/data.
Question. What is the Department's timeline for implementing other
provisions of the Act?
Answer. ED's implementation of the Evidence Act is informed by the
recommendations of the Commission on Evidence-Based Policymaking, the
Federal Data Strategy's Principles and Practices, and the Office of
Management and Budget's Phase 1 guidance on Evidence Act implementation
(M-19-23). Our implementation also is informed by discovery and
assessment activities in our own agency that led to a coherent ED Data
Strategy that now serves as ED's roadmap to data maturity.
The ED Data Strategy--the first of its kind for the U.S. Department
of Education--was released in December of 2020. The four ED Data
Strategy goals are highly interdependent with cross-cutting objectives
requiring a highly collaborative effort across ED's offices.
--The strategy calls for strengthening data governance to administer
the data it uses for operations, answer important questions,
and meet legal requirements. To that end, we are developing a
holistic agency-wide framework with established data governance
structures, functions, roles, policies, and procedures and
developing a comprehensive data quality framework for the
agency.
--To accelerate evidence-building and enhance operational
performance, it requires that ED make data more interoperable
and accessible for tasks ranging from routine reporting to
advanced analytics. To inform decisionmaking processes, we are
working to connect fragmented data from disparate sources, so
we can answer critical questions, and strengthen grant
programs' performance and accountability measures.
--The high volume and evolving nature of ED's data tasks necessitates
a focus on developing a workforce with skills commensurate with
a modern data culture in a digital age. We are developing an ED
data workforce plan to support long-term planning for our data-
related human capital needs; we are also building the capacity
of our data workforce while we increase data literacy among all
staff.
--At the same time, safely and securely providing access for
researchers and policymakers helps foster innovation and
evidence-based decisionmaking at the Federal, state, and local
levels. Aligned with these efforts, we are developing an Open
Data Plan, while awaiting OMB guidance on final requirements
for that plan; we are also building toward a comprehensive data
inventory to catalog data assets for both external open data
and internal sources and will incrementally expand the number
of Department data assets listed in the Federal Data Catalog.
Achieving the four ED Data Strategy goals requires a concerted
effort to address short-term challenges and thoughtfully set a course
for long-term data maturity. Each Goal includes a set of objectives--
designed to be completed in the next 12 to 18 months--that form an
action plan for tackling short-term challenges to continue building the
foundation of a data-driven culture. Future objectives under the four
goals will iteratively represent the next set of implementation
challenges to raise ED offices and the agency as a whole to an even
higher level of data maturity.
______
Questions Submitted by Senator Richard J. Durbin
Question. The Department notified me and other Members of Congress
on February 13, that Secretary DeVos had decided not to extend the
closed school discharge look-back period for students who attended
schools owned by Education Corporation of America (ECA). As the
Department has previously stated, ``during the months of March, April,
and May 2018, ACICS placed many locations of ECA on either campus-level
show-cause or campus-level compliance warning due to student
achievement rates'' and on ``May 8, 2018, ACICS placed ECA on show-
cause due to adverse action by another agency.''
Actions toward the removal of accreditation are a clear example of
exceptional circumstances as provided under 34 CFR Sec. 685.214. Will
you reconsider this decision?
Answer. Question answered elsewhere in this document.
Question. In that same February notification, the Department noted
that Secretary DeVos had not yet made a decision on the request from me
and other Members of Congress made on December 21, 2018, to extend the
look back period for Vatterott students--which also met the exceptional
circumstances bar in the law.
Will you look into this matter and render a decision?
Answer. The Department is cognizant of the significant harm to
students that occurs when a college suddenly closes. We are reviewing a
number of school closures to determine whether an extension of the
look-back window is appropriate, and hope to be able to share more on
the results of that review soon.
Question. On June 23, 2021, the Department provided a response to a
letter I sent on October 29, 2020, with several colleagues to then-
Secretary DeVos. Secretary DeVos failed to respond. Your Department's
response mentioned the announced rulemaking in several of the areas
mentioned in the letter--including closed school discharge.
While I'm pleased the Department is taking up many of these issues
in rulemaking, when can we expect a decision from you to the specific
requests in the letter--related to extending closed school look-back
dates?
Answer. We are reviewing a number of school closures to determine
whether an extension of the look-back window is appropriate, and hope
to be able to share more on the results of that review soon.
Question. Since June 2018, the Department has released borrower
defense data on a quarterly basis:
Please provide a breakdown of ``total denied'' borrower defense
claims to date by institution.
Answer. Beginning in December 2019, the term ``total denied'' was
no longer used in the quarterly borrower defense reports. The term
``total ineligible'' is used to refer to applications in which the
borrower has been notified that their claim does not meet the
requirements for a borrower defense to repayment discharge.
Question. Please provide a breakdown of ``total ineligible''
borrower defense claims to date by institution.
Answer. An Excel file providing the requested data as of June 30,
2021, is enclosed.
Question. Please provide a breakdown of ``total closed'' borrower
defense claims to date by institution.
Answer. An Excel file providing the requested data as of June 30,
2021, is enclosed.
Question. How many schools are being investigated for misconduct
due to borrower defense claims filed by their students?
Answer. The Department does not comment on deliberative,
preliminary, or ongoing investigative work, including disclosing a
number or list of institutions that may be subject to such work until
the outcomes of any investigations have been issued to the institutions
or entities. Nevertheless, the Department notes that it has opened
numerous investigations in 2021 and will be holding schools accountable
where appropriate. For schools with findings of misrepresentation or
misconduct, the Department will use evidence in connection with our
borrower defense fact-finding process.
Question. Please provide a list of for-profit colleges for which
the Department is aware of pending state or Federal investigations or
lawsuits--and the corresponding state or Federal entities.
Answer. The Department does not maintain a formal list of for-
profit colleges with pending state or Federal investigations or
lawsuits. However, the Department collaborates closely with law
enforcement partners where appropriate and requests evidence and input
when their investigations of for-profit colleges result in evidence
that the Department may consider in connection with its efforts to hold
schools accountable.
Question. For how many borrowers whose borrower defense
applications have been approved has the Department or its agents made
corrected reports to credit reporting agencies? What percentage?
Answer. FSA requires our vendors to remove the credit tradeline for
any loans that are approved for 100 percent borrower defense relief.
Question. How many and which institutions is the Department
currently investigating for purposes of making findings related to
borrower defense?
Answer. The Department does not comment on deliberative,
preliminary, or ongoing investigative work, including disclosing a
number or list of institutions that may be subject to such work until
the outcomes of any investigations have been issued to the institutions
or entities. To the extent that a Department investigation results in
obtaining evidence that may be relevant to borrower defense claims, the
evidence will be given to FSA's Borrower Defense Group for use in its
fact-finding process. Additionally, the Department is in the process of
increasing staffing within FSA's Investigations Group to advance these
efforts.
Question. Since the 2014 collapse and 2015 bankruptcy of Corinthian
Colleges, Inc., many for-profit colleges have followed suit--closing
their doors as part of a planned teach-out or shuttering precipitously.
In these cases, students are eligible for Federal closed school
discharges. Many are also eligible for Federal student loan discharges
through the Higher Education Act's borrower defense provision as a
result of their institution's fraud and misconduct. We cannot let
students be left holding the bag. At the same time, the Department's
enforcement failures, failures to hold accreditors accountable,
attempts to roll back the Gainful Employment and Borrower Defense
rules--including provisions allowing students to hold institutions
directly accountable in court for misconduct--mean that taxpayers are
ultimately on the hook.
Please provide the cumulative cost of approved closed school and
borrower defense discharges (including automatic closed school
discharges under the 2016 Borrower Defense rule) associated with for-
profit colleges since 2014.
Answer. As of June 30, 2021, the cumulative effectuated closed
school and borrower defense discharges amount is approximately $2.2
billion. This includes almost $1.1 billion in borrower defense
discharges and more than $1.1 billion in closed school discharges,
including automatic closed school discharges. The Department is
continuing to process the discharges of the roughly 91,800 borrower
defense approvals that have been announced in press releases in recent
months.
Question. Please provide the cumulative amount that the Department
has recouped from institutions for closed school discharge costs
associated with for-profit colleges since 2014.
Answer. The Department's recoupment of loan discharge liabilities
is a trailing process which follows the Department's quantification of
actual discharged loan amounts and assertion of liabilities. In
general, when an institution closes, it is required to submit a
``Close-Out Audit'' report to the Department. When FSA resolves a
close-out audit, it quantifies closed school loan discharges and
asserts liabilities in the final audit determination for the close-out
audit report. FSA may also pursue additional recovery of liabilities
arising after the close-out audit is resolved. In all cases, the
Department must provide institutions with appeal rights to challenge
asserted liabilities and the Department does not pursue collections
while an appeal is pending. In addition, the circumstances of some
school closures may require the Department to pursue recoveries through
protracted bankruptcy proceedings. To that end, the Department has
recouped more than $10.4 million from institutions for closed school
discharge costs associated with for-profit colleges since 2014.
Question. Please provide the cumulative amount that the Department
has recouped from institutions for borrower defense discharge costs
associated with for-profit colleges since 2014.
Answer. The Department has not recouped any costs associated with
borrower defense discharges from institutions. All approved claims to
date relate to closed schools.
Question. According to the April 2021 borrower defense report, the
Department currently has nearly 108,000 pending borrower defense
claims. Please provide:
The average length of time the 108,000 claims have been pending;
Answer. The average length of time that all applications have been
pending as of June 30, 2021, is 748 days. This is not specific to the
108,000 claims referenced, but rather the total number of pending
applications, which includes those in the Awaiting Adjudication and
Pending Notification categories, as of June 30, 2021.
Question. The percentage of pending claims related to for-profit
institutions (including institutions that have been for-profit
institutions within the past 10 years), public institutions, and
private not-for-profit institutions respectively;
Answer. As of June 30, 2021, 88 percent of total pending
applications were related to for-profit institutions; 4 percent were
related to public institutions; and 8 percent were related to private
not-for-profit institutions. A small number of applications (less than
1 percent) include those without a school assigned and those involving
foreign institutions.
Question. A breakdown of the 108,000 pending claims by institution;
and
Answer. An Excel file providing the requested data as of June 30,
2021, is enclosed. Please note that institutions may appear on the list
several times because the data was pulled based on the institutions' 8-
digit OPEID.
Question. A list of all group discharge applications the Department
has received from State attorneys general including the date submitted,
by whom, the school/programs, and the number of covered borrowers and
the status of each application.
Answer. Information regarding the group discharge requests from
attorneys general is provided in the enclosed file.
Question. How many of the applications referenced in (d) are
pending? How many have been granted? How many have been denied? Please
provide a list of each.
Answer. All of the AG submissions referenced in (d) are currently
under review.
Question. For each of the years 2016, 2017, 2018, 2019, 2020, and
2021 how many borrowers covered by a group discharge application are in
default on their Federal student loans?
Answer. At this time, the Department cannot narrow its reporting to
individual applications submitted by attorneys general. Most of the
attorney general submissions did not specifically identify the
borrowers covered by their group requests, and the Department is
currently working to identify the borrowers at issue.
Question. For each of the years 2016, 2017, 2018, 2019, 2020, and
2021 how many loans of the borrowers covered by a group discharge
application have been certified by the Department of Education for
Treasury offset?
Answer. Please see answer to question 10(f), above.
Question. For each of the years 2016, 2017, 2018, 2019, 2020, and
2021 how many borrowers covered by a group discharge application have
been subject to an administrative wage garnishment order put in place
by the Department?
Answer. Please see answer to question 10(f), above.
Question. For each of the years 2016, 2017, 2018, 2019, 2020, and
2021 what are the total dollar amounts of Federal student loans
(interest and principal) covered by each group discharge application
from a State attorney general?
Answer. Please see answer to question 10(f), above.
Question. For each of the years 2016, 2017, 2018, 2019, 2020, 2021
what are the total dollar amounts collected through the Treasury Offset
Program on defaulted student loans covered by each group discharge
application from a State attorney general?
Answer. Please see answer to question 10(f), above.
Question. In January 2017, State attorneys general--led by
Illinois--provided the Department with program-level enrollment data
for borrowers in their states that were covered by the Department's
Corinthian job placement misrepresentation findings. How many of these
borrowers have still not received relief despite being eligible?
Answer. Due to data limitations, FSA is unable to respond to this
question at this time. While the Illinois Attorney General did provide
a borrower list in December 2016, the list did not contain the unique
identifiers (Social Security Number and/or date of birth) necessary to
confidently match to borrowers in FSA's systems. The Department is now
working to identify any borrowers submitted by the Illinois Attorney
General and any other attorneys general who may be covered by the job
placement rate findings, as that work was not done previously.
Question. 34 CFR 685.300 governs Program Participation Agreements--
the contracts between schools and the Department of Education. CFR
685.300(e) prohibited schools from making or enforcing class action
bans and mandatory pre-dispute arbitration agreements.
Answer. As a preliminary observation, the Program Participation
Agreement (PPA) is primarily governed by 34 C.F.R. Sec. 668.14. 34
C.F.R. Sec. 685.300 provides additional participation requirements when
a school participates in the Direct Loan program. The provisions of 34
C.F.R. Sec. 685.300 are inapplicable if an institution elects not to
participate in the Direct Loan program. The provisions were removed
effective July 1, 2020. Therefore, the response to question a. extends
only to June 30, 2020.
Question. In how many schools' Program Participation Agreements did
the Department include this prohibition?
Answer. From July 21, 2019 and through June 30, 2020, the
Department created and executed Program Participation Agreements (PPAs)
that have included specific language referencing class action bans and
pre-dispute arbitration agreements for 1,155 schools. As of July 29,
2021, 1,070 of these schools were approved to participate in the Direct
Loan program, and 85 schools were not approved to participate in the
Direct Loan program. PPAs created before July 21, 2019, contained
overarching language indicating that schools were required to comply
with all Title IV, Higher Education Act and Direct Loan program
participation requirements, which would extend to the restrictions
relating to class action suits and pre-dispute arbitration agreements.
Question. In how many instances did the Department seek to enforce
this prohibition? What actions did it take?
Answer. The Department does not comment on deliberative,
preliminary, or ongoing investigative work, including the enforcement
of the Title IV regulations. Generally speaking, through our program
review authority, we will monitor compliance with the requirements that
schools end enforcement of any existing mandatory pre-dispute
arbitration clauses and class action restrictions in enrollment
agreements.
Question. Are you aware of any class actions that schools
participating in Title IV forced into arbitration while the prohibition
was in effect?
Answer. The Department is aware of two competing cases that relate
to the prior regulation, which is no longer in effect. The regulation
itself was subject to multiple implementation delays and litigation. In
Kourembanas v. InterCoast Colleges, a class action in the District of
Maine, 17-cv-00331, the court granted a motion to compel arbitration.
And in Young v. Grand Canyon University, the appellate court reversed
the Northern District of Georgia's initial decision to compel
arbitration in Carr et al. v. Grand Canyon University, 19-cv-01707.
Question. Please provide a list of all institutions for which the
Department currently holds a letter of credit or other surety and the
amount of such letter of credit or other surety.
Answer. Enclosed is an Excel file containing data on the Letters of
Credit (LOC) and other surety that the Department held as of July 14,
2021. As of July 14, 2021, the Department held 403 LOCs and other
surety from institutions, totaling more than $607.3 million in
financial protection. The first tab of the Excel file contains
institutional and other data regarding the LOCs held by the Department
as of July 14, 2021. The second tab provides the field definitions and
descriptions of the reasons why a LOC was requested from a listed
institution. Please note that this report differs from reports posted
to FSA's Data Center identifying LOCs requested by the Department
during an Award Year period. It is a ``snapshot'' of LOCs held by the
Department as of July 14, 2021 and it provides the most recent
information recorded in FSA's data sources regarding these LOCs. The
report does not provide historical context for the LOCs held as of July
14, 2021 in cases where FSA may have required an institution to renew
or amend a previously provided LOC. In a limited number of cases, the
report also identifies and includes funds held on deposit by the
Department in lieu of a LOC.
Question. Regarding institutional compliance with the incentive
compensation rules to date, please provide:
The number of program reviews, investigations, audits, or other
reviews that have examined institutional compliance with the
requirements of incentive compensation;
Answer. The Department has issued determinations for 60 program
reviews that were initiated during fiscal years 2017--20 and fiscal
year 2021 through June 30, 2021 that examined institutional compliance
with incentive compensation requirements.
The Department received and finalized its review and audit
resolution process for more than 15,900 compliance audit reports whose
audit period included any portion of fiscal years 2017, 2018, 2019,
2020, or 2021 through July 28, 2021. The compliance audit reports were
prepared either in accordance with the OIG's Guide for Audits of
Proprietary Institutions and For Compliance Attestation Engagements of
Third Party Servicers Administering Title IV Programs, or in accordance
with the OMB Compliance Supplements (2 CFR Part 200, Appendix XI--
Compliance Supplement) for audits reports prepared under the Single
Audit Act. The scope of these audits included audit objectives for an
independent auditor to determine whether the auditees did or did not
comply with the incentive compensation prohibitions.
Additionally, the Department conducted close to 300 ``New School
Visits'' during fiscal years 2017--20 and fiscal year 2021 through July
28, 2021 that reviewed incentive compensation requirements. A New
School Visit is a process focused on the start-up issues and needs of
schools that are new Title IV participants or that might not have
recent Title IV experience. A New School Visit is not a program review,
but rather a tool used to identify and eliminate any weaknesses that,
if left unaddressed, could result in improper use of Federal funds and
possible liabilities for the school. A standard component of a New
School Visit includes a discussion of incentive compensation
requirements, which may lead to the identification of a compliance
deficiency.
Question. how many program reviews, investigations, audits, or
other reviews found;
Answer. The Department has identified 10 instances of incentive
compensation noncompliance in the population of finalized program
reviews, investigations, and other reviews conducted in fiscal years
2017--20 and fiscal year 2021 through July 28, 2020, and finalized
compliance audit resolutions whose audit period included any part of
fiscal years 2017-20 and fiscal year 2021 through July 28, 2021.
Question. Noncompliance with the requirements of incentive
compensation; and the actions the Department has taken to ensure that
institutions correct deficiencies in compliance with the requirements
of incentive compensation
Answer. The Department has issued fine actions totaling $3,411,002
for four institutions in fiscal years 2017--20 and fiscal year 2021
through July 28, 2021.
Question. In recent years, several for-profit colleges have
attempted to convert to not-for-profit status in an effort to avoid the
stigma associated with the predatory for-profit college industry and to
avoid regulations meant to protect students and taxpayers. Dream Center
Education Holdings, which collapsed leaving thousands of students
stranded and whose conversion received preliminary Department approval,
is just one example. Please provide a list of all for-profit
conversions in the last 10 years including those pending (with current
status), previously approved, and denied or withdrawn.
Answer. An Excel file providing the requested information is
enclosed. Within the last 10 years, the Department has received 78
applications for a for-profit to nonprofit conversion. Of those 78
applications, the Department has made final decisions on 40 conversion
requests as of August 1, 2021. Of those 40 decisions, 37 were
approved.\*\ The Department denied Argosy University's request for
nonprofit recognition. The Department also denied Grand Canyon
University's and the American Academy of Art College's requests for
nonprofit recognition when it approved their respective Change in
Ownership applications. Additionally, 18 applications, including pre-
acquisition review applications, were closed due to a voluntary
withdrawal or school closure. There are 19 outstanding conversion
requests, and one pending pre-acquisition application where the Change
in Ownership date is imminent.
---------------------------------------------------------------------------
\*\ In August 2016, the four main locations operated by the Center
for Excellence in Higher Education (CEHE) were originally denied their
conversion request. Following the receipt of additional information and
an updated valuation in October 2018, the Department determined that it
would be appropriate to grant those institutions conditional approval
to convert to nonprofit institutions and issued Provisional Program
Participation Agreements in December 2018. The Department's December
2018 determination of CEHE's nonprofit status--based on the new
information CEHE provided--also provided a basis to dismiss a
longstanding lawsuit filed against the Department, because that was the
relief sought in the lawsuit. Just recently, under pressure from
further reviews of its conduct by FSA, CEHE made the decision to close
its remaining campuses effective Aug. 1, 2021. Additionally, one
approved Change in Ownership transaction involving Kaplan University
and Purdue University resulted in Kaplan University's conversion to
public institution status (rather than to nonprofit institution
status).
Question. Please provide, disaggregated for Corinthian Colleges,
Inc., ITT Educational Services, Inc., Charlotte School of Law,
Education Corporation of America, Vatterott Colleges, and Dream Center
Education Holdings, respectively:
The number of borrowers and the total loan amount of such borrowers
for whom the Department estimates are eligible for the applicable
closed school discharge window (either 120 days or as extended due to
``exceptional circumstances'');
The number of borrowers and the total loan amount of borrowers who
applied for a non-automatic, traditional closed school discharge;
The number of borrowers and the total loan amount that has been
discharged through non-automatic, traditional closed school discharge;
The number of borrowers and the total loan amount that has been
discharged through automatic closed school discharge; and
The number of borrowers and the total loan amount of such borrowers
in some form of debt collection (Treasury offset, wage garnishment,
assigned to PCAs).
Answer. Please find an Excel file with the requested data enclosed.
Question. Your predecessor allowed borrower defense claims to
balloon at the Department without processing any claim for more than a
year. At one time, the backlog had grown to several hundred thousand
claims. As pressure mounted to clear the backlog--of her own creation--
Secretary DeVos issued blanket and cursory denials of tens of thousands
of claims. Many of these are potentially meritorious claims that were
simply cast aside by the previous administration that always looked at
borrower defense as more of a problem to ignore than a mechanism for
justice and fairness. What steps will you take to review the DeVos
Department's borrower defense denials?
Answer. The Department agrees that all borrowers who have filed
borrower defense to repayment applications deserve a thorough and fair
review that is done as expediently as possible. While the Department
continues to approve new categories of borrower defense claims, I have
asked Federal Student Aid to conduct extensive outreach to state
attorneys general, other government agencies, and any other parties
that might be in possession of evidence showing institutional
misconduct. I have also asked FSA to reopen any borrower defense
denials when new evidence, or any other evidence in FSA's possession,
indicates misconduct or other concerns that were not considered during
the initial adjudication. In addition, FSA is conducting a review of
our policies related to borrower defense and will reopen any denied
claims based upon any of those policy changes.
The Department is working diligently to process borrower defense
claims in a timely manner. We are aware of the significant number of
borrowers with a denied claim and are reviewing potential options for
these borrowers.
Question. You recently announced an ambitious higher education
regulatory agenda which will include topics like gainful employment,
for-profit conversions, borrower defense, financial responsibility,
administrative capability. While I'm pleased the Department is
undertaking this process, it is lengthy and the Department's rules
subject to litigation. As it goes through the negotiated rulemaking
process, how will the Department--under your leadership--use its
extensive existing authorities to engage in aggressive oversight and
enforcement activities related to predatory for-profit colleges?
Answer. The Department of Education is working to ensure stronger
oversight of predatory institutions through multiple venues. I expect
that the rulemaking process will help the Department to design far
stronger protections against predatory practices by institutions.
Additionally, the Office of Federal Student Aid is working to ensure
careful oversight of institutions, investigating reports of problematic
practices and increasing monitoring of institutions that receive
Federal aid under Title IV of the Higher Education Act. The new Chief
Operating Officer of FSA, Richard Cordray, is committed to ensuring
consumer protection is embedded in how FSA serves students and
borrowers.
Question. During the Obama Administration, then-Secretary Arne
Duncan created a Federal interagency taskforce to coordinate oversight
and enforcement efforts related to for-profit colleges. The task force
was based on a bill that the late Rep. Elijah Cummings and I wrote
called the Proprietary Education Oversight Coordination Improvement
Act. The task force was successful in coordinating Federal action in
response to misconduct by several for-profit colleges--including a $100
million DeVry settlement with the Federal Trade Commission. Would you
be open to recreating this task force that was disbanded by Secretary
DeVos?
Answer. The Department is deeply interested in strengthening
oversight of misconduct across higher education. The interagency task-
force created by the Obama Administration provided a critical
opportunity for collaboration to identify potential illegal practices
and misrepresentations. The Department is already working to
reestablish those relationships with other Federal agencies through
MOUs and data-sharing agreements, as well as opening the lines of
communication with state Attorneys General, to improve accountability
in higher education.
Question. As part of the American Rescue Plan (Public Law 117-2),
Congress closed the 90/10 loophole which incentivized for-profit
colleges to prey on student veterans and servicemembers. I understand
that the bill prohibited the Department from promulgating regulations
to implement the statutory change before October 2021. In the meantime,
will the Department release Federal 90/10 data which counts accurately
as Federal revenue all revenue received by for-profit colleges from
Federal taxpayer-funded educational assistance programs? This would
include Department of Veterans Affairs GI Bill and Department of
Defense Tuition Assistance funding. While this data could not be used
for enforcement purposes yet, it would be very helpful to the public's
understanding of the problem. In fact, the Department released this
data, upon my request, in December 2016. On December 10, 2018, Chairman
Takano, Senator Carper, Representative Cohen, Ranking Member Murray,
Chairwoman DeLauro, Ranking Member Reed, Chairman Adam Smith, Senator
Blumenthal, Representative Susan Davis, and I wrote to then-Secretary
DeVos asking her to continue this data release. She refused during her
tenure.
Answer. As referenced in your question, section 2013 the American
Rescue Plan Act modifies section 487(a)(24) of the Higher Education Act
of 1965 (HEA) to require a proprietary institution to derive not less
than 10 percent of such institution's revenues from sources other than
``Federal funds that are disbursed or delivered to or on behalf of a
student to be used to attend such institution.'' The Department
unfortunately does not have an updated report covering Federal 90/10
data that counts accurately as Federal revenue all revenue received by
for-profit colleges from Federal taxpayer-funded educational assistance
programs report to release to you. Additionally, the Department does
not maintain the requisite VA, DoD, and other Federal education
benefits program funding data to prepare an updated 90/10 impact
analysis.
The Department wishes to clarify that although it released a 90/10
data report in 2016 covering VA and DoD funds, the Department did not
prepare that report. The Department's 2016 press release indicates DoD
and VA prepared that 90/10 estimate. The Department's December 21,
2016, transmittal letter identifies significant data limitations and
includes a cautionary note against using the data to draw inferences
about individual institutions or trends. The Department's subsequent
March 28, 2019, response to your December 2018 letter reiterated these
themes.
Due to the complexity and individualized nature of the 90/10
evaluation including, but not limited to, a requirement for an
institution to use the cash basis of accounting under section
487(d)(1)(A) of the HEA, an institution's 90/10 compliance is disclosed
in an institution's audited financial statement notes. To perform an
accurate analysis of the impact of the statutory change, an evaluation
must be conducted at the individual student account receivable level
for every recipient of any type of Federal taxpayer-funded educational
assistance program who attended every proprietary school. This type of
analysis is necessary in view of the requirements. The Department has
no confidence that any other analytical approach would yield the
accurate assessment requested.
The Department appreciates your longstanding concern with
institutions receiving Federal education benefits from multiple funding
sources. However, the knowing release of a report that uses
questionable data and depends on unsound assumptions could have harmful
effects in advance of the upcoming rulemaking, including possibly
misinforming and misleading members of the public who may seek to
forecast the anticipated impact of new rules, which may undermine
public trust. The Department is also concerned that the release of an
inaccurate report would violate the Government Accountability Office's
(GAO's) Standards for Internal Control in the Federal Government (GAO-
14-704G), especially Principle 13, ``Use Quality Data.''
Question. Over the last four fiscal years, this Subcommittee--with
the support of Chairman Blunt and Ranking Member Murray--has provided
$24 million to an Open Textbooks Pilot to expand the use of open
textbooks on college campuses to achieve savings for students. While
this program may be small, it has energized students and faculty across
the country who see open textbooks--free, high-quality alternatives to
costly traditional textbooks--as key to reducing student debt and
improving learning outcomes. Many students don't purchase required
course materials because they are too costly. It puts them at an
academic disadvantage and hits low-income, first-generation, and
students of color hardest. So, on a bipartisan basis, Congress created
this program. In early June, the Department made nine new awards with
its fiscal year 2021 appropriation--funding down the slate of fiscal
year 2020 applications. I am pleased that the Department took
Congressional directive and made a great number of awards. In order to
do so though, the Department only funded 1 year of the applicants'
projects. It was my understanding that if the Department took that
step, it would fully fund those nine projects pending the appropriation
of additional funds in fiscal year 2022.
Please confirm that remains the Department's intention.
How is that intention being relayed, with the appropriate caveats,
to the 9 grantees?
Answer. The Department worked extensively with Congress to identify
and implement a funding strategy that would maximize the number of new
awards in fiscal year 2021 that could be awarded with the $7 million in
available funding, ultimately making nine new awards from the fiscal
year 2020 slate. This strategy required a shift from the previous
strategy of frontloading OTP grantees, an approach that fully paid all
multi-year project costs with a single year's appropriation, but which
consequently required making a much smaller number of awards. The
larger number of awards enabled by the shift to incremental funding
allowed roughly twice as many highly rated applicants to launch their
projects in fiscal year 2021 as would have been possible with
frontloading. The Department used approximately $5.9 million to pay
first-year costs and approximately $1.1 million to partially pay down
the second-year costs for the 2021 OTP cohort. We plan to use an
estimated $8.3 million in fiscal year 2022 funds to pay remaining
second- and third-year costs for this cohort, as shown in the fiscal
year 2022 Congressional budget justification for this program.
While the project period for these grantees does not begin until
September 1, 2021, program staff have held post-award calls with the
nine grantees to explain the impact of the change in funding strategies
for the 2021 OTP cohort.
Question. When you came before us, I asked you about the high
percentage of denials under the Public Service Loan Forgiveness (PSLF)
program. You voiced your support for PSLF and your determination that
borrowers receive the forgiveness that they expected and to which they
are entitled. PSLF reform is part of the higher education regulatory
agenda that you have announced. What steps will you take
administratively, outside of formal rulemaking, to help fix the
problems with PSLF?
Answer. As we continue investigating the challenges of PSLF, the
Department is committed to undertaking a serious review of the PSLF
program and to making improvements that will result in better access to
relief for eligible borrowers. In addition to including PSLF on the
regulatory agenda, we recently issued a Request for Information (RFI),
inviting feedback on borrower experiences and possible policy solutions
with the PSLF program, to identify broader areas for improvement. The
Department has already begun to make improvements, including by
launching and updating the PSLF Help Tool, by allowing lump sum and
prepayments to count as qualifying payments, and by creating a single
application for PSLF, Temporary Expanded PSLF (TEPSLF), and Employment
Certification Forms (ECFs). We look forward to making additional
administrative and operational improvements that help eligible
borrowers access the benefits they have earned.
Further, on October 6, 2021, the Department of Education announced
an overhaul of the PSLF Program that it will implement over the next
year to make the program live up to its promise. This policy will
result in 22,000 borrowers who have consolidated loans--including
previously ineligible loans--being immediately eligible for $1.74
billion in forgiveness without the need for further action on their
part. Another 27,000 borrowers could potentially qualify for an
additional $2.82 billion in forgiveness if they certify additional
periods of employment. All told, the Department estimates that over
550,000 borrowers who have previously consolidated will see an increase
in qualifying payments with the average borrower receiving another 2
years of progress toward forgiveness. Many more will also see progress
as borrowers consolidate into the Direct Loan program and apply for
PSLF, and as the Department rolls out other changes in the weeks and
months ahead.
The first major change will result in a limited PSLF waiver that
allows all payments by student borrowers to count toward PSLF,
regardless of loan program or payment plan. This waiver will allow
student borrowers to count all payments made on loans from the Federal
Family Education Loan (FFEL) Program or Perkins Loan Program. It will
also waive restrictions on the type of repayment plan and the
requirement that payments be made in the full amount and on-time for
all borrowers.
Given this new policy, borrowers who currently have FFEL, Perkins,
or other non-Direct Loans, will receive the benefit of this limited
waiver if they apply to consolidate into the Direct Loan program and
submit a PSLF form by October 31, 2022. The waiver applies to loans
taken out by students.
Also, these changes will allow active duty service members to count
deferments and forbearances toward PSLF. This solves a problem for
service members who have paused payments while on active duty but were
not getting credit toward PSLF.
The Department is automatically providing credit toward PSLF for
military service members and Federal employees using Federal data
matches. The Department will implement data matches next year to give
these borrowers credit toward PSLF without an application.
Finally, the Department is reviewing denied PSLF applications for
errors and giving borrowers the ability to have their PSLF
determinations reconsidered. These actions will help identify and
address servicing errors or other issues that have prevented borrowers
from getting the PSLF credit they deserve.
Question. Students' Federal financial aid for higher education is
dependent on their expected family contribution. For many students from
low-income families, their expected family contribution qualifies them
for Federal assistance in the form of a Pell Grant. To confirm accurate
family contributions, some financial aid applications are flagged for
additional verification. Past data from the Department shows that over
half of Pell-eligible applicants were selected for verification in
2015-2016. It is estimated that more than 1 in 5 low-income students
selected for verification never complete the process, thus never end up
receiving Federal financial aid. Students who receive Pell grants have
much higher college retention rates than their peers who are Pell
eligible but do not receive the aid. This data implies it is possible
that the verification process is disproportionately harming the
educational success of low-income students, which is the opposite
intention of the Pell Grant program. The 2017/2018 Award Year ushered
in a new verification model. The Quality Assurance Program ended, which
had given institutions of higher education discretion on application
verification, leaving the Department to select which students needed to
be verified. The risk-model developed by the Department to identify
which FASFA applications needed verification led to a drastically
higher percentage of applications flagged. In fact, some schools
reported that nearly 50 percent of Pell eligible students were selected
for verification multiple times over their course of study even though
their financial information hadn't changed.
Please provide the metrics by which the Department selects which
applications are to be verified.
Answer. Prior to 2018, FSA relied solely on a Classification and
Regression Tree (CART) model to choose FAFSA filers for financial
verification. The CART model used combinations of Targeted Selection
Criteria (TSC) to choose FAFSA filers for verification. In September
2017, FSA funded the creation of an advanced Python-coded machine
learning model (MLM) to improve FSA's verification selection model by
better identifying applicants for whom an error on the FAFSA was more
likely to impact their Expected Family Contribution and, ultimately,
their Federal aid award. FSA has used this model since October 1, 2018.
The MLM updates the criteria used for selection of FAFSA filers for
verification to a gradient boosting classification and regression
model. The metrics the model employs to choose FAFSA filers for
verification include data from the FAFSA, as well as demographic data,
in several complex algorithms. In certain cases, TSC are used to
supplement MLM selection, and a small percentage of applicants are
randomly selected to provide necessary data for model building and
evaluation. As part of this single, overall selection process, a
separate TSC model is used to select applicants for identity/fraud
verification.
Finally, for your awareness, in July we announced some
modifications to our verification approach to the 2021-2022 FAFSA
processing cycle in response to the challenges and barriers resulting
from the ongoing national emergency by focusing solely on identity and
fraud. We continue to evaluate potential approaches for upcoming cycles
to ensure that they are balanced and equitable.
Question. What percentage of students chosen for verification, did
not complete, and failed their verification during the last award year
under model?
Answer. FSA uses the receipt of either a Pell Grant or Subsidized
Direct Loan as a measure of whether an applicant successfully completes
verification once selected. Of those selected for verification during
the 2020-21 FAFSA cycle, 64.5 percent received either a Pell Grant or a
Subsidized Direct Loan. Some students that submit a FAFSA do not enroll
in an institution of higher education for a variety of reasons, so we
would not expect this percentage to equal 100. Therefore, to understand
the impact of the verification process on student enrollment, the
Department compares this rate to the population not chosen for any type
of verification. The rate for those not selected for verification
receiving either a Pell Grant or a Subsidized Direct Loan is 56.8
percent. Please note this data is as of July 28, 2021 and may change
slightly as Award Year 2021 aid is finalized.
Question. We have a student debt crisis that isn't going to resolve
itself. Currently 45 million Americans hold more than $1.7 trillion in
student loan debt. Student debt is larger than credit card debt in our
nation. It is second only to mortgages when it comes to consumer debt.
The average debt per student borrower is more than $37,000. Most of
this is in Federal student loans. The student debt crisis is limiting
young people's life and career choices. Americans are putting off
starting a family and buying a home because of student debt. And it's
not just young people. More than 8 million Americans over age 50 have
student loan debt. For years, I have introduced legislation to fix the
absurd way that the bankruptcy code treats student debt. If a person
overextends himself on his credit card or goes into debt buying a car
or a boat or a luxury watch, he can address those debts in bankruptcy.
But the bankruptcy code provides no meaningful relief for student loan
debt. In 1998, Congress put Federal student loans in the category of
nondischargeable debts, along with alimony, child support, overdue
taxes, and criminal fines. Right now, the only way a student borrower
can get bankruptcy relief for student loans is if she can demonstrate
``undue hardship.'' This standard is not defined in law, and courts
have interpreted it to make it nearly impossible to meet. But,
Secretary Cardona, you have the ability to help this situation. The
Department of Education can set internal standards for when it views an
undue hardship as being met, and can direct its contractors and
servicers not to challenge those undue hardship claims in bankruptcy
court. For years, I have urged previous Secretaries of Education to use
this authority and to issue undue hardship guidance for its guaranty
agencies and contractors. There are categories of debtors where undue
hardship can be presumed--for example, debtors who suffer from certain
disabilities, or who have had a low income for a number of consecutive
years. If the Department would use this authority, it would create an
option of last resort for student debtors who truly have nowhere else
to turn. Will you commit to issue guidance on the Department's views of
when an undue hardship claim can be met?
Answer. The Administration is committed to ensuring that student
loan borrowers have options to make the burden of student loans more
manageable . The consequences of delinquency and default on Federal
student loans can be substantial, particularly for borrowers who are
suffering from other economic hardships, including many who ultimately
file for bankruptcy relief on their debts. We have already taken
initial actions to support borrowers; but we recognize that more work
remains to be done.
To that end, the Department is committed to reviewing its 2015
guidance on undue hardship student loan discharges in bankruptcy
proceedings, as well as other policies related to such proceedings to
assess the types of changes that might better protect borrowers. We
hope to have more to share on this soon.
Question. A recent report by the National Student Loan Defense
Network, entitled ``The Missing Billion,'' highlights the aggressive
tactics the Department uses to collect from struggling borrowers--
including challenging claims of undue hardship in bankruptcy. At the
same time, the report finds that the Department has failed to collect
on more than $1 billion owed to taxpayers by for-profit institutions
and executives. Please comment on the findings of this new report.
Answer. The National Student Loan Defense Network's (NSLDN's)
report, ``The Missing Billion,'' compares the differences in the
Department's collection of liabilities owed by institutions and its
collection of student loans owed by individual borrowers in default.
This difference primarily comes from statutory provisions that make it
difficult to hold individual owners liable for the corporate debts of
the institutions, in contrast to provisions that substantially limit
any bankruptcy relief under an ``undue hardship'' standard. See 11
U.S.C. Sec. 523(a)(8). The ``undue hardship'' standard applies to
educational debts when individuals seek bankruptcy protection. In
seeking to enforce that standard uniformly, the Department considers as
a factor the availability of several student loan repayment plans that
can take a borrower's circumstances into account to reduce a borrower's
scheduled loan installments to a more affordable monthly payment.
The Department uses oversight measures as provided in the
Department's regulations to identify institutions that are financially
weak and institutions with impaired administrative capability. These
measures include monitoring the numeric composite score of financial
responsibility, requiring institutions with failing financial scores to
provide letters of credit (LOCs), using Heightened Cash Monitoring
(HCM) methods of payment, and provisional certification to monitor
schools' compliance with the Department's requirements to mitigate
risk.
Frequently, LOC amounts, HCM requirements, and provisional
certification are linked to an institution's performance under the
Department's financial responsibility requirements and an institution's
numeric composite score determined by financial analysis of the
institution's annual financial statements in accordance with the
Department's regulations. Consistent with the Department's regulations,
LOC amounts are indexed to an institution's annual Title IV, HEA
funding. The proceeds of LOC collections can be applied towards an
institution's unpaid debts after any related appeals are fully
resolved. When the Department perceives increased financial or
administrative risk, the Department may require institutions to comply
with more stringent requirements, such as raising the amount of
financial protection an institution must provide and increasing the
level of scrutiny applied to payment requests through the HCM2 method
of payment. The Department also considers risks associated with
increased compliance requirements. One outcome of stringent enforcement
and oversight can be that an IHE may close if it is unable to fully
comply with more rigorous requirements, such as a posting a larger LOC.
The Department's Office of Finance and Operations collects debts
owed to the Department and follows applicable Federal debt collections
laws, including the Debt Collection Improvement Act of 1996, when
collecting debts and when referring delinquent debts for collections.
If an institution files for bankruptcy, it immediately loses
eligibility to participate in the Title IV, HEA programs. The
Department is bound to follow applicable bankruptcy law and pursues
debt recovery from the institution's estate through the bankruptcy
court. Institutions that close often do so with a lot of debt and
limited assets to be distributed among the creditors. Collection of
liabilities against an institution is generally limited to the direct
owner corporate entity unless there is litigation to ``pierce the
corporate veil,'' which often proves difficult. Litigation to recover
liabilities against individuals can only be brought by the U.S.
Department of Justice and requires piercing the corporate veil in order
to hold individuals personally accountable. The Department has taken
steps to prevent individuals with unpaid school debts or bad track
records running schools from operating other schools. The Department's
past performance regulations can bar school owners who owe unpaid debts
from owning or exercising substantial control over other schools until
their outstanding debts are paid.
We are reviewing the report to determine if there are any
outstanding actions that need to be resolved for currently
participating schools. While the report is critical of the Department's
administration of debts owed by institutions, an initial reading also
indicates the report contains unfounded conclusions and inaccurate
claims because it fails to take into account the requirements to
establish liabilities against institutions. The report also appears to
misinterpret the data provided to NSLDN via the Freedom of Information
Act (FOIA).
As an example, the report is critical of the Department's
administration of debts owed by institutions owned by Zovio, Inc, and
claims the Department failed to collect a $883,613 liability amount
assessed against the University of the Rockies (owned by Zovio, Inc.).
In actuality, the Department's efforts to collect this liability
(arising from a final close-out audit determination) have been
suspended in accordance with 34 C.F.R. Part 668, Subpart H--Appeal
Procedures for Audit Determinations and Program Review Determinations
because an appeal is currently pending resolution with the Department's
Office of Hearings and Appeals. The suspension of collections is
required under the Department's regulations at 34 C.F.R.
Sec. Sec. 668.23(f)(1); (g)(1)(i)-(ii); and 668.123. These regulations
provide that an institution must repay an audit liability within 45
days of the date of the Department's notification, unless the
institution files a timely appeal or unless a longer repayment period
is permitted. A liability may be established but not paid in full
because an institution is repaying the liability owed under a repayment
agreement. The Department monitors institutional compliance with
repayment requirements. Failure to comply with these repayment
requirements is a violation of the Department's financial
responsibility standards, as described above.
The report suggests that Department improperly issued a Program
Participation Agreement to Ashford University (also owned by Zovio,
Inc.) while Ashford owed a $32,965 liability. The Department's Federal
Student Aid office received confirmation on Oct. 5, 2016, that Ashford
University had fully repaid the $32,965 liability to the Department on
Sept. 9, 2016. The Department would not dispute that the $32,965
receivable erroneously included in the records provided to NSDLN
through the FOIA request was the result of a recordkeeping error.
However, before the Department provided a Program Participation
Agreement to Ashford University on Oct. 20, 2017, the Department had
determined that Ashford had fully paid the liability.
As another example, the report states ``The Department has asserted
a $283,782,751 claim in the bankruptcy proceeding against ITT Technical
Institute, plus an additional $1,544,738 against the school due to its
ownership and operation of Daniel Webster College. Yet the Department's
list of unpaid debt only includes approximately $343,000 from ITT and
nothing with respect to Daniel Webster College.'' In this instance, the
Department did not issue final determinations associated with the debts
identified in the proof of claim to avoid violating the automatic stay
provisions of the Bankruptcy Code.
The NSLDN report unfortunately misinforms its readers that ``[t]he
Department's inaction has irrevocably cost at least $218 million
because the statute of limitations on collections has expired'' by
misconstruing 28 U.S.C. Sec. 2462. The NSLDN report cites as support 28
U.S.C. Sec. 2462 and the Lincoln University case (Docket 13-68-SF),
April 25, 2016, in Footnote 35. A reading of 28 U.S.C. Sec. 2462
undermines the notion that there is a statute of limitations on
collections. Rather, 28 U.S.C. Sec. 2462 establishes a statute of
limitations for commencing actions to assess civil fines, etc. which
must be commenced within 5 years from the date when the claim first
accrued. In Lincoln University, the Department asserted on Oct. 25,
2013, fines for Clery Act violations which occurred on Oct. 1, 2006,
and were repeated annually on that date until 2009 under the
Department's regulations at 34 C.F.R. Part 668, Subpart G--Fine,
Limitation, Suspension and Termination Proceedings (Subpart G). The
question was whether the Sec. 2462 statute of limitations for these
violations had elapsed based on the date the violation occurred. After
close review of Sec. 2462, the Subpart G hearing official held in the
initial decision dated March 16, 2015 that the statute of limitations
barred the Department's fines for the 2006, 2007, and 2008 Clery Act
violations, but that the fines for the 2009 violations were not barred.
There is however no discussion in the Lincoln University decisions to
support the assertion that a fine is uncollectable under Sec. 2642
simply because the debt is asserted or continues to exist more than 5
years after the claim first accrued. Indeed, the initial and remand
decisions ordering payment of fines in Lincoln University were dated
more than 5 years after the violation. To assert otherwise implies that
those who are subject to a civil penalty or fine action can evade and
self-discharge their payment obligation after 5 years of making no
payments. Additionally, 28 U.S.C. Sec. 2462 only applies to civil
fines, penalties and forfeitures; it does not apply to repayment
liabilities. Funds owed back to the Title IV program are not subject to
any statute of limitations.
Question. Two decades ago, a CDC study came out that changed the
way we think about public health. It was called the Adverse Childhood
Experiences or ``ACEs'' study and it established the link between
exposure to trauma--things like witnessing violence or an overdose--and
our long-term health, education, and economic outlook. We now
understand how trauma and ACEs harm brain development and how having
multiple of these emotional scars can reduce life expectancy by up to
20 years make you two times less likely to graduate high school and
make you 10 times more likely to attempt suicide. Prior to COVID-19, we
already had an epidemic of gun violence, suicides, and overdoses--all
of which exacerbate and stem from the root issue of trauma. But the
pandemic has magnified this problem, with a recent CDC study finding a
50 percent increase in suicide attempts by teenage girls. Senator
Capito of West Virginia and I teamed up in 2018 to pass legislation to
increase funding and coordination across the Departments of Education
and HHS to promote this understanding of trauma in more Federal grant
programs. Specifically, we authorized a $50 million trauma and mental
health services grant program for schools, which we have not yet been
able to fund. This grant program--Section 7134 of the SUPPORT Act--
would support schools in adopting trauma-informed practices, training
more staff, engaging families, and forging partnerships with clinical
mental health professionals. I know the Biden Administration is
proposing $1 billion to support more counselors in schools--sign me up
for that. Would you also support appropriations for this already
authorized program to address the breadth of trauma needs in schools--
setting up comprehensive plans, trainings, and partnerships, beyond
just adding school psychologists or counselors?
Answer. COVID-19 has had a devastating impact on many families,
contributing to significant trauma resulting from isolation, economic
stress, housing insecurity, and the loss of loved ones, among other
traumatic events. Prior to COVID-19, many of these kinds of traumas and
others already existed and were only further exacerbated by the
pandemic. A significant number of students, predominantly students from
low-income backgrounds, rely on their schools for access to mental
health services and other services that are intended to meet their
physical, social, emotional, and mental health needs. The need for all
students, especially those most underserved, to have access to these
critical services is why the Department requested $1 billion to double
the number of school counselors, nurses, social workers, and school
psychologists over the next decade. It is also why we requested $250
million for IDEA, Part D Personnel Preparation to support the pipeline
into the profession , including mental health service providers, and
their preparation, development, and support. The Department is also
requesting $443 million to support Full Service Community Schools--
schools which have in place the kinds of comprehensive plans and
partnerships you describe to support students and families. We also
call for increased investments in the Promise Neighborhoods, School
Safety National Activities, and Student Support and Academic Enrichment
Grants programs, all in effort to provide a comprehensive set of
investments intended to mitigate the impact of traumatic experiences
and help our students heal from the trauma, develop, and thrive. We
look forward to working with you to make these kinds of critical
investments in existing programs and identify additional opportunities
for targeted and increased investments.
Question. Multiple Congressionally mandated Department of Education
studies of the D.C. Opportunity Scholarship program--the only
federally-funded voucher program--have found that the program does not
improve the academic achievement of students in the program. In fact,
two recent Department of Education studies of the program found that
students using vouchers have performed worse academically than their
peers not in the voucher program. And, previous studies have indicated
that many of the students in the voucher program are less likely to
have access to key services such as ESL programs, learning supports,
special education supports and services, and counselors than students
who are not part of the program. Moreover, a study from the Urban
Institute found that receiving a voucher does not increase D.C.
students' college enrollment rates. Given these troubling findings, do
you support continuing Federal support for the program?
Answer. The Administration seeks to phase out the D.C. Opportunity
Scholarship Program while providing scholarships to students currently
participating in the program through 12th grade. Accordingly, the
Administration has requested level funding for fiscal year 2022 to
continue funding scholarships for continuing students in school year
2022-2023.
______
Questions Submitted by Senator Jack Reed
Question. PSLF and Military Service Members--Earlier this year, the
Government Accountability Office (GAO) issued a report finding that 94
percent of the Public Service Loan Forgiveness (PSLF) applicants in
military service or Department of Defense (DoD) civilian jobs were
denied. Additionally, the GAO recommended that the Department of
Education could take additional steps to improve information sharing
about PSLF with DoD about military service members and DoD civilian
personnel seeking to participate as well with potential beneficiaries.
According to the GAO, as of February 17, 2021, 178,215 active-duty
service members had direct loans eligible for PSLF, and another 16,195
active-duty service members had Federal loans that could be
consolidated into new qualifying direct loans. These statistics offer
just a small snapshot of the full scope of eligible military borrowers
who should be benefiting from the protections of PSLF since borrowers
first became able to secure forgiveness through the program in 2017.
Using the Department of Defense's DMDC website, please provide the
total number of active duty service members (and veterans) with Federal
student loans who have served since PSLF launched on October 1, 2007
and who continue to be in repayment on Director Loans and/or FFELP
loans.
Answer. FSA is working to produce such an analysis, in
collaboration with the Department's Office of the General Counsel and
the Department of Defense.
Question. Please provide information on the Department's efforts to
implement the GAO recommendations. Also please include information
about the Department's plans to use any other authority, such as
authorities under the HEROES Act of 2003, to ease the process and
expand access to PSLF for military service members.
Answer. The Government Accountability Office (GAO) made two
recommendations for the Secretary of Education in its recent report,
``Public Service Loan Forgiveness: DoD and Its Personnel Could Benefit
from Additional Program Information (GAO-21-65).'' The other three
recommendations in the report were addressed to the Department of
Defense (DoD).
First, the GAO recommended that Federal Student Aid (FSA)
collaborate with officials in DoD's Office of the Under Secretary of
Defense for Personnel and Readiness to share information about the
Public Service Loan Forgiveness (PSLF) Program, including current
information on program participation and eligibility, as well as
program requirements. The Department concurred with the recommendation
and has already begun this collaboration with DoD. For example, FSA had
already begun discussions with DoD about enhancements to our digital
toolsets and is actively working with DoD on providing more and
improved information to employees interested in PSLF.
Second, the GAO recommended that FSA update the student loan guide
for service members to provide information on applying for PSLF and
TEPSLF, as well as the steps borrowers can take to count their annual
payment from DoD's student loan repayment program as multiple
qualifying payments for the PSLF program. The Department again
concurred with the recommendation and intends to update the next
version of the student loan guide for service members to reflect the
new combined PSLF form, which no longer requires borrowers to
separately apply for TEPSLF. In addition, FSA currently makes
information available on lump sum payments made by DoD for service
members through StudentAid.gov. We agree this information should be
included in the next version of the student loan guide for service
members. FSA will work with DoD to ensure there are clear instructions
for borrowers participating in DoD's student loan repayment program to
earn qualifying payments for the PSLF Program.
On October 6, 2021, the Department of Education announced a set of
actions that, over the coming months, will restore the promise of PSLF.
We will offer a time-limited waiver so that student borrowers can count
payments from all Federal loan programs or repayment plans toward
forgiveness. This includes loan types and payment plans that were not
previously eligible. We will pursue opportunities to automate PSLF
eligibility, give borrowers a way to get errors corrected, and make it
easier for members of the military to get credit toward forgiveness
while they serve. We will pair these changes with an expanded
communications campaign to make sure affected borrowers learn about
these opportunities and encourage them to apply.
The Department is working hard to eliminate barriers for military
service members to receive PSLF. The Department will allow months spent
on active duty to count toward PSLF, even if the service member's loans
were on a deferment or forbearance rather than in active repayment.
This change addresses one major challenge service members face in
accessing PSLF. Service members on active duty can qualify for student
loan deferments and forbearances that help them through periods in
which service inhibits their ability to make payments. But too often,
members of the military find out that those same deferments or
forbearances granted while they served our country did not count toward
PSLF. This change ensures that members of the military will not need to
focus on their student loans while serving our country. Federal Student
Aid will develop and implement a process to address periods of student
loan deferments and forbearance for active-duty service members and
will update affected borrowers to let them know what they need to do to
take advantage of this change.
Finally, the Department is working to automatically help service
members and other Federal employees access PSLF. Military service
members and other Federal employees devote themselves to serving the
United States, and we should make it as easy as possible for them to
receive PSLF. Next year, the Department will begin automatically giving
Federal employees credit for PSLF by matching Department of Education
data with information held by other Federal agencies about service
members and the Federal workforce. To date, approximately 110,000
Federal employees and 17,000 service members have certified some
employment toward PSLF. These matches will help the Department identify
others who may also be eligible but cannot benefit automatically, like
those with FFEL loans.
Question. Restarting Student Loan Repayment--Payments on Federal
student loans have been paused for over a year due to the pandemic,
with borrowers currently expected to begin repaying their student loans
on October 1 of this year. There are indications that the restart will
trigger unprecedented outreach to servicers, with survey data showing
that servicers could field inquiries from more than 9 million
borrowers. There have been indications that it will take approximately
2-4 months for servicers to rehire, train, and obtain background checks
for their workforce.
As the U.S. Department of Education and its student loan servicers
prepare for the repayment restart, what are the essential steps that
the Department is considering to ensure a seamless return to repayment?
What is the timeframe for implementing these steps so that the Office
of Federal Student Aid and servicers have sufficient time to implement
this plan so that both borrowers and servicers can prepare? What is the
Department's monitoring plan for servicers on their implementation of
the restart of repayment?
Answer. The Department's goal is to achieve a smooth transition
that minimizes borrower harm due to confusion, lack of awareness, and
insufficient servicing capacity. To this end, the Department has
produced a comprehensive plan that combines elements of borrower
outreach, servicer hiring, training and preparation, and vendor and
process oversight to ensure borrowers have the resources they need to
effectively manage the process of returning to repayment.
From an outreach perspective, in March 2020, FSA launched an
ongoing communications and engagement campaign to provide borrowers
clear, concise messaging related to available CARES Act benefits and
the eventual transition to repayment. Since then, FSA has engaged in
continuous communication efforts to encourage student loan borrowers to
take actions to put them on the best repayment plan for their economic
situation before payments resume. From July 2020 until the end of
February 2021, FSA sent over 220 million emails to borrowers,
supplemented by multiple paid media campaigns.
FSA has also posted information on StudentAid.gov to assist
borrowers in preparing for payments to resume, specifically
recommending that borrowers update their contact information with their
loan servicer and in their StudentAid.gov profile, use Loan Simulator
to find a repayment plan that meets their needs and goals, and consider
applying for an income-driven repayment plan. As we approach the end of
the forbearance period, outreach to borrowers will increase and include
broad campaigns aimed at increasing general awareness of payment
resumption and options to address ability to repay, as well as targeted
outreach to at-risk borrowers.
To ensure our servicers are prepared for the restart of repayment,
FSA engaged in ongoing conversations with loan servicers about their
preparations and staffing levels since the CARES Act was passed in
March 2020. During the payment pause, FSA has clearly communicated
expectations for how loan servicers should engage with borrowers. FSA
is continually analyzing historical, current, and projected future loan
servicer staffing levels against several customer service metrics to
ensure servicers are ready for payments to resume. As we prepare for
borrowers to enter repayment, FSA will provide detailed communications
``playbooks'' for loan servicers to follow. To ensure loan servicers
are held accountable for customer service performance during the return
to repayment effort, FSA plans to add explicit return-to-repayment
performance expectations, called service level agreements (SLAs), to
the servicers' existing contracts. Proposed SLAs would focus on call
center performance, such as abandon rates and Average Speed to Answer,
to ensure borrowers have prompt, easy access to information. As
borrowers exit the payment suspension period, FSA will expand our
monitoring to include all aspects of return to repayment. Vendors who
fail to adhere to any statutory, regulatory, or contractual standards
will be held accountable through appropriate corrective actions, which
may include financial penalties.
On Aug. 6, 2021, the Department announced a final extension of the
payment pause until Jan. 31, 2022. The Department is already working
diligently to ensure a smooth transition back to repayment for all
borrowers
The pause on student loan repayment will end on January 31, 2022,
and we are planning around that date. The Department's priority is to
ensure students and borrowers get the service they deserve. We are
committed to ensuring that student loan borrowers are able to
transition smoothly into repayment. The Department has established
timelines with key deadlines related to returning student loans to
repayment. Those plans include substantial communications and outreach
to make borrowers aware of the resumption of loan payment obligations.
FSA also continues to communicate with servicers about return to
repayment as information becomes available. Additionally, the
Department plans to collaborate with Federal and state regulators to
ensure our oversight of Federal student loan servicers is as effective
as possible, and are working to ensure the tools available to the
Office of Federal Student Aid are used to the fullest extent possible.
Question. FFEL and Repayment Relief--In April, Senator Murkowski
and I sent you a letter asking you to address the over 5 million FFEL
and the roughly 1.7 million Perkins loans borrowers who have been left
out of the CARES Act relief and the subsequent extensions of the pause
on student loan repayment.
What steps is the Department taking to ensure that all Federal
student loan borrowers have equal access to any current or proposed new
relief and benefits?
Answer. We have taken steps to assist those FFEL borrowers that
have defaulted during the national emergency. In March 2021, the
Department announced that the payment pause on interest and collections
would be extended to all defaulted FFEL loans, protecting more than
800,000 borrowers from debt collection activity such as wage
garnishment and seizure of tax refunds. FFEL loans on which borrowers
defaulted since March 13, 2020, the start of the national emergency,
are being restored to good standing, and the record of default removed
from their credit reports. The Department continues to explore
additional opportunities to aid all Federal student loan borrowers,
whether they hold FFEL, Perkins, or Direct Loans, and to ensure that
their payments remain affordable, particularly during a period that has
been challenging for so many borrowers.
______
Questions Submitted by Senator Joe Manchin, III
Question. I want to once again thank you for working with myself
and Senator Murkowski on getting out the first tranche of the American
Rescue Plan funding for homeless children and youth in an expedited
manner, so we could ensure that homeless children and youth are
identified and are able to access summer programming and wrap-around
supports they need in light of the COVID-19 Pandemic. In the
Department's initial announcement surrounding this funding, you
indicated that the second tranche of this funding could be available as
soon as June, to help states and school districts prepare for the fall.
This is critical as we expect to see even greater numbers of
homelessness and higher level of service needs, as communities return
to in person learning.
Can you tell me if those plans for the release of the second
tranche of homelessness funding are on schedule, and will be out this
month?
Answer. The awards for the second tranche of American Rescue Plan
funding for homeless students were made on July 27, 2021.
Question. In the final fiscal year 2021 spending package, I was
able to secure language urging the Department to ensure that local
educational agencies (LEA's) set aside adequate amounts of Title I Part
A funds for students experiencing homelessness and use those resources
effectively.
Can you tell me what the Department has done to date to implement
this request and does this budget proposal do anything to implement
that language further?
Answer. In July 2018, the Department sent a letter to State
educational agencies (available at: https://oese.ed.gov/files/2020/02/
letterforessatitleialeahomelesssetaside-1.pdf) that highlights the
requirement that an LEA reserve sufficient funds under Title I, Part A
to provide services for students experiencing homelessness. This
clarification was included in an update in August 2018 to the non-
regulatory guidance for the Education for Homeless Children and Youth
(EHCY) program and it is also part of the monitoring protocol for the
EHCY program. The Department asks the States that it is monitoring to
provide a list of all Title I, Part A set-asides by LEA. These are
compared with the latest available homeless student enrollment counts,
which usually lag by 1 year. The SEA is asked to explain if any LEAs
had homeless students enrolled but did not set aside a reservation from
Title I, Part A to serve them. We also correlate a per-pupil amount to
look for statewide patterns of insufficiency. The EHCY State
Coordinator Handbook developed by the National Center for Homeless
Education (NCHE) has a Summary of EHCY Performance Management Pilot
Monitoring, fiscal year 2015-18 that summarizes which States had
findings or recommendations in this area (Indicator 3.3). For fiscal
year 2022, due to the American Rescue Plan funds for homeless children
and youth, the Department will expand its monitoring of States for
homeless education programs, including the Title I, Part A LEA set-
aside.
In addition, NCHE also provides technical assistance concerning
Title I, Part A requirements for serving students experiencing
homelessness (see https://nche.ed.gov/legislation/title-1-part-a/).
The key proposal in the fiscal year 2022 request that would support
stronger implementation of Title I requirements related to meeting the
needs of homeless students is the additional $20 billion for Title I,
which would more than double funding for Title I districts and schools,
direct more funds to LEAs with the greatest concentrations of poverty,
and help close equity gaps for all students, including homeless
students.
Question. Student loan disclosure forms are essential in helping
students and families understand the costs and terms of their student
loans, but as currently written they are filled with unhelpful legal
jargon, are complicated. lengthy, and don't show the true cost
associated with taking out the loans leading to excess borrowing,
further contributing to the nation's student debt crisis.
What is the Department doing to address this issue and simplify
student loan disclosure forms? Is there anything in this budget
proposal to help with this?
Answer. We are regularly looking at ways to help students,
families, and borrowers better understand and support their efforts to
meet their student loan obligations. For instance, we continue to
promote use of the College Financing Plan, which provides a
standardized financial aid offer letter so students can understand and
compare their options for paying for college. If there are additional
improvements you have in mind, my staff would be grateful to have them
for consideration.
______
Questions Submitted by Senator Roy Blunt
student loan servicing
Question. Mr. Secretary, your budget requests $2.1 billion, which
is an increase of $200 million from the fiscal year 2021 level, to
administer the student aid programs. Yet the budget provides very few
details about how those funds would be used on student loan servicing
activities aside from mentioning a ``long-term servicing solution.''
Can you provide the Subcommittee additional details on your plans for
the long-term servicing solution?
Answer. The Department is currently working on its long-term
servicing plans and looks forward to sharing more information in the
future.
Question. For the last several years the Labor/HHS bill has
included appropriations language requiring the allocation of Federal
student loans to servicers based on the quality of their performance to
encourage the Department to leverage competition among student loan
servicers. The budget request proposes to strike this language because
the requirement will be included in FSA's ``long-term servicing
solution'' despite the fact that no information is included in the
request on what the long-term solution will look like. How will you
continue to hold the Federal student loan servicers to performance-
based allocations as required by years of appropriations laws
regardless of what a future long-term servicing solution may look like?
Answer. The Department currently allocates loan volume based on
servicer performance. We will continue this practice going forward
under the two-year extensions of servicer contracts (as outlined in the
appropriations language), as well as in the future under the final
servicing solution.
Question. The Department has struggled to complete the contracting
process to fully implement its Next Generation Financial Services
Environment. In light of that prolonged struggle, what are your plans
for using the current five Business Process Operations contractors,
which were awarded in June 2020, in the servicing of student loans
moving forward?
Answer. As you are aware, the Consolidated Appropriations Act, 2021
included several provisions related to the future state of loan
servicing, including provisions directly applicable to the Interim
Servicing Solution (ISS) solicitation and Business Process Operations
(BPO) contracts. Specifically, the language prohibited the use of ISS
as a transitional servicing solution and called for an accelerated BPO
implementation that would make it possible for BPO providers to perform
the full suite of loan servicing activities upon migrating accounts to
the ISS platform. After reviewing the change in the solicitation's
requirements as a result of the appropriations provisions, Federal
Student Aid (FSA) decided to cancel the ISS solicitation.
FSA is using this opportunity to work with our new leadership in
the Biden-Harris Administration to refine our long-term strategy for
loan servicing, with the first priority being to ensure student loan
borrowers have a stable, reliable, and accountable solution that meets
their needs. In developing this long-term solution, FSA will continue
to build on the newly modernized systems, tools, and resources for
customers. In particular, FSA expects to leverage the new
StudentAid.gov, the myStudentAid mobile app, and enhanced systems that
allow FSA to improve how we collect and analyze data, offer more self-
service options, provide better customer service, and communicate
directly with students, parents, and borrowers.
In addition, FSA will continue its work to bring BPO vendors online
in preparation for a fall 2021 migration of all non-servicing contact
center work. This work includes taking on FSA's legacy contact center
functions, including the Federal Student Aid Information Center,
Student Loan Support Center, Feedback Center, FSA Ombudsman, borrower
defense hotline, and Office of Inspector General fraud referral. The
BPO vendors will handle much of FSA's direct communication with
customers and partners, including inbound and outbound calls, email,
chat, social media inquiries, and physical correspondence. BPO vendors
will receive training from FSA to ensure they are providing customers
with correct and consistent information and are treating customers and
partners equitably.
The five-month transition to fully onboard the BPOs is expected to
begin in November 2021 and be finalized by April 2022.
career pathways
Question. Programs that provide academic and career counseling and
exposure to postsecondary opportunities to students, as early as 8th
grade and continuing through secondary and postsecondary education,
have been shown to significantly increase rates of postsecondary
enrollment and completion among rural students. To that end, the fiscal
year 2021 Labor/HHS bill included $10 million for the Department of
Education to improve rates of postsecondary enrollment and completion
among rural students through development of career pathways aligned to
high-skill, high-wage, or in-demand industry sectors and occupations in
the region. What is the timeline for publishing a Notice Inviting
Applications for these funds? What can you tell me about how the
Department plans to prioritize and spend this funding this year?
Answer. While the Department is still developing a notice inviting
applications (NIA), we plan to make up to 7 awards to institutions of
higher education and other public and private non-profit organizations
and agencies for 3-year projects that would implement innovative
approaches to improve rates of postsecondary enrollment and completion
among rural students through development of career pathways aligned to
high-skill, high-wage or in-demand industry sectors and occupations in
a specific region.
Question. The budget request proposes a new $1 billion program to
expand career pathways for middle and high school students,
particularly in underserved communities. This Subcommittee will only be
considering the discretionary request, but providing students in high
school or middle school with access to quality work-based learning
opportunities and exposure to their full range of postsecondary college
and career opportunities should be happening in every school. How will
additional funding for CTE help meet that goal?
Answer. Additional funding under both the Career and Technical
Education (CTE) State Grants formula program and CTE National Programs
would support opportunities to provide high school or middle school
students with access to quality work-based learning opportunities and
exposure to postsecondary college and career opportunities, albeit in
different in ways. The reauthorization of the Perkins Act in 2018 added
provisions and requirements pertaining to work-based learning and
including students in middle school in certain CTE activities. However,
States and local grantees have been expected to implement these and
other new requirements with relatively small increases in funding.
After more than a decade of relatively flat funding, the increase in
funding for the program since fiscal year 2019 (the implementation date
for the reauthorized Perkins program) has been approximately 5.7
percent. Increases for this program would provide additional resources
to State and local grantees to implement these provisions.
Increases in funding under CTE National Programs would provide
opportunities to quality work-based learning opportunities and exposure
to support and evaluate targeted activities to provide high school or
middle school students with access to postsecondary college and career
opportunities. Under that program the Department could fund focused,
high quality proposals for such activities and set priorities for
funding, such as funding to high-poverty LEAs and LEAs serving a high
percentage of students of color or a high percentage of students from
low-income backgrounds.
k-12 covid-19 funding/school reopening
Question. Mr. Secretary, you and I both agree it is crucial that we
get kids back in the classroom to prevent further learning loss. While
I'm encouraged to see that more and more schools are reopening for in-
person learning, the latest data from the Department shows that only 51
percent of 4th graders and 41 percent of 8th graders are enrolled in
fully in-person learning and these numbers are even worse for low-
income and minority students. Given the significant amount of COVID-19
emergency funding that has gone to K-12 schools, I would expect these
numbers to be closer to 100 percent. What actions have you taken to
help states and school districts use their ESSER funds to reopen
schools and get kids back in the classroom? Do you expect that all
schools will be fully open for in-person learning this fall?
Answer. We are doing everything possible to support students,
families, teachers, staff, school leaders, and communities to in
returning to full-time, in-person learning this fall, and the
Administration is confident that we, as a nation, will achieve this
goal to the greatest extent possible.
Most recently, on August 2, 2021, the Department released the
``Return to School Roadmap,'' an online resource available at https://
sites.ed.gov/roadmap/to support students, schools, educators, and
communities as they prepare to return to safe, healthy in-person
learning this fall and emerge from the pandemic stronger than before.
The Roadmap includes three ``Landmark'' priorities that schools,
districts, and communities are encouraged to focus on to ensure all
students are set up for success in the 2021-2022 school year: (1)
prioritizing the health and safety of students, staff, and educators,
(2) building school communities and supporting students' social,
emotional, and mental health, and (3) accelerating academic
achievement. The Roadmap also includes planned releases of additional
resources for practitioners and parents on each of these priorities and
will highlight schools and districts that are using innovative
practices to address these priorities. These resources also will
explain how American Rescue Plan funds, including ESSER funds, can be
used to address these priorities in schools and communities across the
country.
The Roadmap is part of the Department's broader efforts to support
schools and districts in the safe and sustained return to in-person
learning since the beginning of the Biden Administration. In addition
to releasing the Roadmap, the Department has issued three volumes of
the COVID-19 Handbook to support K-12 schools and institutions of
higher education in their reopening efforts, prioritized the
vaccination of educators, school staff and child care workers,
published a Safer Schools and Best Practices Clearinghouse, which
includes over 200 examples of schools and communities safely returning
to in-person learning, held a National Safe School Reopening Summit,
provided $122 billion in support through the American Rescue Plan
Elementary and Secondary School Emergency Relief Fund for K-12 schools,
provided over $3 billion in IDEA funds within the American Rescue Plan
to support children and families with disabilities impacted by the
pandemic, awarded $800 million within the American Rescue Plan to
support students experiencing homelessness who have been
disproportionately impacted by the pandemic, released a report on the
disparate impacts of COVID-19 on underserved students, and launched an
Equity Summit Series focused on addressing school and district
inequities that were made worse by the pandemic.
student loan pause
Question. Mr. Secretary, I am concerned that the Administration has
not outlined a plan to transition borrowers back into repayment when
the student loan pause ends this fall. Now that the pandemic is winding
down, it is time for this pause to end. Furthermore, the extension of
the pause beyond what was originally authorized in the CARES Act cost
taxpayers an additional $36 billion. I understand that some borrowers
may still be struggling, but they have access to income-driven
repayment plans where they can pay as little as $0 per month. Will you
commit to end the pause as scheduled at the end of this fiscal year?
Answer. On Aug. 6, 2021, the Department announced a final extension
of the payment pause until Jan. 31, 2022. We believe this additional
time and definitive end date will allow borrowers to plan for the
resumption of payments and reduce the risk of delinquency and defaults
after restart. The Department is already working diligently to ensure a
smooth transition back to repayment for all borrowers
Question. Federal student loan borrowers have gone over a year
without making a payment on their loans. It is absolutely imperative
that the Department begins communicating with borrowers early and often
to ensure that all borrowers understand their responsibilities and
their repayment options when their loans come due on October 1, 2021.
What are your plans to help ensure that borrowers are prepared to
begin repaying their loans when the pause ends?
Answer. In March 2020, FSA launched an ongoing communications and
engagement campaign to provide borrowers clear, concise messaging
related to available CARES Act benefits and the eventual transition to
repayment. Since then, FSA has engaged in continuous communication
efforts to encourage student loan borrowers to take actions to put them
on the best repayment plan for their economic situation before payments
resume. From July 2020 until the end of February 2021, FSA sent over
220 million emails to borrowers, supplemented by multiple paid media
campaigns.
FSA has also posted information on StudentAid.gov to assist
borrowers in preparing for payments to resume, specifically
recommending that borrowers update their contact information with their
loan servicer and in their StudentAid.gov profile, use Loan Simulator
to find a repayment plan that meets their needs and goals, and consider
applying for an income-driven repayment plan. As we approach the end of
the forbearance period, outreach to borrowers will increase and include
broad campaigns aimed at increasing general awareness of payment
resumption and options to address ability to repay, as well as targeted
outreach to at-risk borrowers.
Question. How will the Department engage the Federal student loan
servicers and provide the necessary instructions so that the return to
repayment process goes smoothly?
Answer. FSA has engaged in ongoing conversations with loan
servicers about their preparations and staffing levels since the CARES
Act was passed in March 2020. During the payment pause, FSA has clearly
communicated expectations for how loan servicers should engage with
borrowers. FSA is continually analyzing historical, current, and
projected future loan servicer staffing levels against several customer
service metrics to ensure servicers are ready for payments to resume.
As we prepare for borrowers to enter repayment, FSA will provide
detailed communications ``playbooks'' for loan servicers to follow.
To ensure loan servicers are held accountable for customer service
performance during the return to repayment effort, FSA plans to add
explicit return-to-repayment performance expectations, called service
level agreements (SLAs), to the servicers' existing contracts. Proposed
SLAs would focus on call center performance, such as abandon rates and
Average Speed to Answer, to ensure borrowers have prompt, easy access
to information. As borrowers exit the payment suspension period, FSA
will expand our monitoring to include all aspects of return to
repayment. Vendors who fail to adhere to any statutory, regulatory, or
contractual standards will be held accountable through appropriate
corrective actions, which may include financial penalties.
Question. Both the CARES Act and the December COVID-19
supplemental, as well as the American Rescue Plan, provided a total of
$161 million to FSA to prevent, prepare for, and respond to the COVID-
19 pandemic. How much of this funding has been used and what has it
been used for?
Answer. As of July 30, 2021, approximately $25 million has been
committed and obligated for the following activities: system changes
due to COVID-19; targeted communication campaigns to notify borrowers
of administrative forbearance; increased server capacity and support
for telework; and personnel and compensation for approximately 38 on-
board staff at FSA to support CARES Act related activities.
Question. Does the Department intend to use the remaining funds to
improve communications and outreach with borrowers about the upcoming
end of the repayment pause?
Answer. Yes, the remaining funds will be used to improve
communications and outreach to borrowers, as well as any additional
actions needed to support borrowers regarding the end of the payment
pause.
charter schools
Question. During the last school year, several states saw
significant enrollment shifts into charter schools. For example,
charter schools in California saw an increase of around 2.5 percent
while districts saw a decrease of 3 percent, Colorado saw a 4 percent
increase while districts saw the same decline. New York City charter
schools had an influx of 10,000 students--a 7 percent increase. And yet
the President's budget does not request new funding for the Charter
Schools program. Given the demand we are seeing at the state level, why
isn't the administration requesting more funds for the Charter School
Program?
Answer. The Administration's fiscal year 2022 request would provide
over $210 million for new awards under the various grant components of
the Charter Schools Program. We believe these resources will be
sufficient to meet demand for funding.
Question. The budget proposes prohibiting Charter School Program
funds from being provided to schools that are substantially operated or
managed through a contract with a for-profit entity. However, most
public schools are utilizing the services of for-profit entities in
some way, including for spending their COVID-19 relief funds.
What does ``substantially operated or managed'' mean? Does it
include contracting for services such as payroll and benefits,
staffing, curriculum, professional development, or individual student
services?
Answer. We recognize that public schools, including charter
schools, may contract with for-profit vendors for specific services
that do not constitute management or control of operations and do not
intend to prevent schools engaged in such procurements from accessing
funds under the CSP or other programs.
Question. Why are you proposing this restriction only for charter
schools? Are you considering this requirement for other programs?
Answer. The Administration believes that Charter Schools Program
(CSP) funds should not support charter schools that are operated or
managed by for-profit entities, and we urge Congress to adopt language
that would prohibit CSP funds from supporting schools that are operated
or managed by such entities through contractual relationships. We
believe this is consistent with intent of the program statute, under
which charter school developers or management organizations seeking CSP
funds must be nonprofit.
title i equity grants
Question. The budget request includes $20 billion for a new Title I
Equity grant that proposes to create a new formula not authorized in
statute to force State and local behavior changes related to school
funding systems, teacher compensation, access to advanced curricula,
and access to preschool. There have been a lot of questions and
concerns about this proposal, specifically how funding would be
allocated. Do you have any further details on the impact of this
formula and where the money would be allocated?
Answer. The Administration remains committed to addressing
longstanding concerns around equity in education funding at the
Federal, State, and local levels. However, we also recognize that
further consultation with a wide range of stakeholders, including
Congress, will be necessary to develop a comprehensive set of proposals
aimed at improving education funding equity that can generate broad
support. Consequently, the Administration supports allocating the
proposed $20 billion increase for Title I through the authorized
funding formulas.
Question. Why is the Department proposing to create a new grant
program that interferes with decisionmaking that is best left to State
and local school districts rather than putting additional funding into
programs we know work to increase student achievement, such as the
Charter Schools Program, or further increasing this existing Title I
programs or IDEA, which has long been underfunded?
Answer. The nearly $30 billion, or 41 percent, increase for the
Department of Education proposed by President Biden for fiscal year
2022 provides strong support for Federal education programs across the
board, including a $3 billion or 21 percent increase for IDEA State
formula grant programs. However, because nearly all Federal education
programs provide supplemental funding, the impact and effectiveness of
that funding depends in large part on a level playing field in terms of
the overall education resources made available at the State and local
levels. For this reason, the Administration strongly believes that a
key goal of any major new Federal investment in education should be to
leverage significant improvement in equity for all students, but
especially for students from low-income families and students of color.
In this context, the Administration is working closely with Congress
and stakeholders to leverage additional investments in Title I to
improve education funding equity, support high-quality preschool,
address teacher compensation, and enhance rigorous coursework in Title
I schools. In that context, the Department believes the proposed $20
billion increase for Title I would provide a meaningful incentive for
systemic changes in the equity of our decentralized education system.
naep funding
Question. NAEP provides crucial information about what our nation's
students know and can do in various subject areas. Ensuring we continue
to have this information is more important than ever given the
widespread learning loss that is expected as a result of the pandemic.
Your budget requests an additional $15 million for NAEP in fiscal year
2022. Will this increase ensure that the planned assessment schedule
can remain on track?
Answer. The $15 million proposed for fiscal year 2022, if sustained
in future years, would support operational funding needs, including
planned assessments, through 2024.
mental health
Question. Mr. Secretary, one of my priorities in the Senate has
been mental health--and ensuring that a person's mental health is
treated the same as their physical health. The Department's budget
requests $1 billion for a new program to increase the number of health
professionals in our public schools, including school counselors,
nurses, school psychologists, and social workers. I share your concern
about the well-being and mental health of our nation's students,
particularly given the widespread disruption to school that students
have experienced over the past year due to the COVID-19 pandemic.
However, states and school districts have yet to spend the vast
majority of COVID-19 funding provided to them, and one of the ways they
can spend this money is to provide mental health services to students.
What has the Department done to help states and school districts use
their COVID-19 funding to support the mental health of their students?
Answer. The Administration has recognized from the beginning of its
response to the pandemic that students need a strong social and
emotional foundation to excel academically. It is clear that many
students, and especially students from low-income backgrounds and
students of color, have suffered much over the past 18 months and
require additional support to help them heal and recover from all the
trauma and hardship the pandemic has brought. And we know for many
students, schools are the only place where they can access mental
health professionals, school counselors, nurses, and support structures
they need--including their friends--to help them through the adversity
of the last year. This is why we have emphasized meeting students'
mental health needs as part of our overall effort to reopen schools for
fully in-person learning, including through the hiring of school-based
health professionals as well as other efforts to address social and
emotional development needs.
For example, the Department published Volume 2 of the ED COVID-19
Handbook: Roadmap to Reopening Safely and Meeting All Students' Needs
(see https://www2.ed.gov/documents/coronavirus/reopening-2.pdf), in
April, 2021, which includes a section on Supporting Student Mental
Health Needs that highlights examples and best practices that States
and school districts can implement using funds provided by the American
Rescue Plan. Additional guidance is provided in our ESSER Fund
Frequently Asked Questions document (see Question C-14 at https://
oese.ed.gov/files/2021/05/
ESSER.GEER--.FAQs_5.26.21_745AM_FINALb0cd6833f6f46e03ba2
d97d30aff953260028045f9ef3b18ea602db4b32b1d99.pdf).
We have seen the results of these efforts in the plans that States
have developed for using ARP ESSER funds. For example, Nevada is
reserving ARP funds to hire 100 school-based mental health
professionals and Alaska is using ARP funds to help social workers
provide virtual lessons in self?care and methods to reduce student
stress, depression, and anxiety. The New York City Department of
Education is using ARP funding to hire over 600 mental health
professionals to provide care as students returned back this fall. This
means that every school will have at least one full-time social worker
or school-based mental health clinic.
In addition, we plan to issue guidance on using ARP funs to address
student mental health needs in fall 2021.
______
Questions Submitted by Senator Cindy Hyde-Smith
Question. The Institute of Education Sciences (IES) funds education
research, data collection and analysis, and a national assessment of
student progress. The fiscal year 2016 Omnibus included a $44 million
(8 percent) increase for IES. The budget request includes a further $76
million (12 percent) increase. The Investing in Innovation (i3) grant
program required that at least 20 percent of recipients be located in
rural areas. The i3 competition has been replaced with a new grant
program, the Education Innovation and Research program, in fiscal year
2017. Geographic diversity in all research grant programs is important.
From 2013 to 2015 the Department made almost 1,900 grants to
institutions of higher education and other research organizations.
However, those grants went to colleges, universities, and research
organizations in only 35 states. Not one went to a school or
organization in Mississippi and generally the same schools and
organizations tend to get the bulk of research grants year after year.
In my state, 92 percent of school districts and more 50 percent of
students are rural, yet most research is conducted in urban and
suburban communities. The Every Student Succeeds Act requires that
schools implement evidence-based strategies to improve student outcomes
yet most education research is conducted in urban and suburban
settings.
How will you ensure that education research addresses the unique
needs of rural districts?
Answer. Supporting education research to help understand and
address the unique needs of rural districts is a priority for IES. We
support education research, including on rural education, primarily
through two funding mechanisms: (1) field-initiated research grants,
and (2) research conducted by the Regional Educational Laboratories. We
discuss the role of each below.
Research Grants. As a scientific agency, funding decisions are
based on peer reviewer's independent assessments of the scientific
merit of applications, including the significance of the proposed
research project, the scientific quality of the research plan, the
skills of the personnel, and the resources available to support the
proposed project. We hold competitions on various topics to ensure that
the education research that we fund meets the needs of the diverse
populations and geographic settings of our nation.
For example, in 2021, IES launched a new research competition
inviting State agencies to apply for funds to expand use of their State
Longitudinal Data Systems (SLDS) for generating evidence in support of
education policy decisions. Using SLDS as a data source ensures that
all districts within a State can be included in their research
activities. Of the 7 awards made, 5 are made to States with substantial
rural populations, including Tennessee, Montana, Virginia,
Pennsylvania, and Oregon. Mississippi received $6.6 million in 2016 for
an NCES SLDS grant that ended 9/30/20 to enhance its SLDS system, so we
encourage the State education agency to apply for funding under this
program for projects using data from its SLDS for research on rural
populations, and to reach out to IES program officers for input as they
prepare their application.
In addition, IES invested $20 million in two five-year research and
development centers focused on the needs of rural education in 2019:
The National Center for Rural Education Research Networks (NCRERN) and
The National Center for Rural School Mental Health (NCRSMH): Enhancing
the Capacity of Rural Schools to Identify, Prevent, and Intervene in
Youth Mental Health Concerns. Rural districts participating in the work
of these two centers are located in: New York, Ohio, Iowa, New Mexico,
Wyoming, Missouri, Virginia, and Montana. Both rural centers are
actively engaged with communities in these States and beyond and are
developing and sharing resources for the rural education community. For
example, NCRSMH has developed an Early Identification System (EIS)
Intervention Hub (https://www.ruralsmh.com/intervention-hub/) designed
to connect rural educators to resources focused on preventing and
remediating student mental health challenges.
In addition, 27 of our new fiscal year 2021 research awards and 16
of our fiscal year 2020 research awards are being carried out in rural
settings. These studies are addressing teacher retention in rural
schools, fostering positive family-school involvement for students from
economically disadvantaged households in rural communities,
interventions to help special educators with behavior management, and
web-based professional development to help teachers improve students,
reading comprehension in rural districts.
The Regional Educational Laboratories (RELs). For more than 50
years, the REL program has worked in partnership with State, district,
and college and university leaders to develop and use research that
improves academic outcomes for students and their communities. REL
Southeast serves has successfully completed a number of projects
focused on the needs of rural communities in Mississippi, including:
--The Improving Schools in Mississippi Research Alliance, a
professional learning community that supports research and
practice on rural school improvement. Partners include district
leadership from the Vicksburg/Warren Public Schools, Durant
Public Schools, Yazoo City Public Schools, Holmes County Public
Schools, and Humphreys County Public Schools, as well as Alcorn
State University and Mississippi Valley State University.
--The Southeast School Readiness Research Alliance, which seeks to
build the capacity of preschool teachers and administrators
across Mississippi and the other five States in the Southeast
region to use evidence-based emergent literacy instruction to
support three-to five-year old children's language and literacy
learning and to help policymakers understand the factors that
influence access to high-quality childcare and preschool
programs.
--Examining School-level Reading and Math Proficiency Trends and
Changes in Achievement Gaps for Grades 3-8 in Florida,
Mississippi, and North Carolina, which detailed student
achievement trajectories for Mississippi students overall and
within student group, supporting stakeholders decisionmaking
about how to prioritize school improvement efforts.
--Educator Outcomes Associated with Implementation of Mississippi's
K-3 Early Literacy Professional Development Initiative, which
examined changes in teacher knowledge of early literacy skills
and ratings of quality of early literacy skills instruction,
student engagement during early literacy skills instruction,
and teaching competencies.
--Beating the Odds in Mississippi: Identifying Schools Exceeding
Achievement Expectations, which identified K-12 schools that
were performing better than would have been predicted and was
used to inform decisionmaking on statewide school improvement
efforts.
--Math Course Sequences in Grades 6-11 and Math Achievement in
Mississippi, which examined the relationship between students'
course-taking patterns in middle- and high-school and their
subsequent performance on college admission tests, supporting
local and State college readiness efforts.
Question. In awarding research grants, how will you ensure that the
Department considers the geographic distribution of research projects
and geographic disparities in education research funding? How will you
ensure funding is going to colleges, universities, and research
institutions in under-researched and underserved areas?
Answer. IES is required by law, under the Education Sciences Reform
Act, to base our funding decisions on the independently assessed
scientific merit of applications. In all of our grant competitions, we
explicitly seek to broaden participation in our research studies and to
expand the populations and geographic settings within which our studies
are taking place. We are currently supporting a research project at the
University of Southern Mississippi (grant award R305A200185) and two
projects that are collaborations between Arizona State University and
Mississippi State University (grant awards R305A180261 and
R305A180144). IES also periodically holds competitions with a specific
focus on addressing the unique needs of rural America, such as the two
R&D Centers on rural education awarded in 2019. It is important to
stress that these are competitive grant programs which are funded based
on the scientific merit of the applications submitted. We do not
include the State or geographic region in which the applicant
institution is located in the selection criteria for our education or
special education research grant programs.
We also actively seek to broaden participation in our applicant
pool through our research training programs. For example, our Pathways
to the Education Science Research Training program was established to
develop a pipeline of talented education researchers who bring fresh
ideas, approaches, and perspectives to addressing the issues and
challenges faced by the nation's diverse students and schools. These
grants are awarded to minority-serving institutions (MSIs) and their
partners. In the initial two rounds of competitions, IES made awards to
7 institutions and their partners. IES is currently accepting
applications for a new program: Early Career Mentoring Program for
Faculty at Minority Serving Institutions that seeks to prepare faculty
at MSIs to conduct high-quality education research that advances
knowledge within the field of education sciences and addresses issues
important to education policymakers and practitioners.
Question. President Biden's campaign included a Plan for Rural
America. That plan opened with the statement ``Rural America is home to
roughly 20 percent of Americans, but we are all connected to rural
communities in many ways. Rural Americans fuel us and feed us. Rural
lands provide us with places to spend time outdoors with friends and
family and relax.'' This statement suggests an attitude that rural
people and places exist to provide for and serve more populated urban
and suburban areas. The current version of the plan, available here
https://joebiden.com/rural-plan/contains some of the same language but
has been revised. It will be important that the administration move
beyond metro-centric policy making to ensure rural schools are treated
equitably.
How will you ensure that policies and practices in the Department
recognize and value the strengths and unique contexts of rural schools
and communities?
Answer. The Department is committed to educational opportunity and
academic achievement for all students throughout the nation, including
those in rural areas. Our Rural Education Achievement Program, for
example, recognizes the need of many rural school districts for
additional funding, as well as flexibility around the use of Federal
education funds, to address their unique circumstances. Similarly, many
of our discretionary (competitive) grant programs include rural set-
asides to ensure that rural applicants receive an equitable share of
grant funds, and we also use grant priorities for rural and new
applicants that help level the playing field and ensure that rural
applicants can compete successfully for Federal funds.
Question. In 2018, the Department released the Section 5005 Report
on Rural Education in response to a provision in the Every Student
Succeeds Act that called on the Department to critically examine its
policies and procedures in related to rural education. The 2018 report
touted some things the Department is doing to ensure the needs of rural
schools and students are met, and also listed steps the Department
intended to implement to address the needs of rural schools. To date,
not all of those seven steps have been accomplished, most notably, NCES
has not updated its 2007 report on the status of rural education. In
2019 this analysis by Devon Brenner (of MSU) of the Section 5005 report
summarized the reports findings and plans or implementation and
critiqued the report, saying ``it falls short of the 5005 mandate to
self-assess and determine actions to be taken. The Department engaged
in listening sessions and sought feedback from rural stakeholders, but
does not seem to have incorporated feedback from key stakeholder
organizations (e.g., AASA and Rural School and Community Trust, The
University Council for Educational Administration (UCEA), the National
Indian Education Association (NIEA), and the National Association of
federally Impacted Schools). The Department commits to increasing
listening sessions and improving communication but is not clear that
rural input is or will be ``baked into'' the system to ensure that
rural communities are considered in every facet of the Department's
work, particularly rulemaking.'' See https://
journals.library.msstate.edu/index.php/ruraled/article/view/535/501.
How will you ensure that the Department completes these commitments
to improve policies and procedures for rural schools and considers the
needs of rural schools in the development of regulations and the
implementation of programs?
Answer. The Department is committed to ensuring educational
opportunity for all students, including those in rural areas, and
recognizes the need to account for all education settings when
developing policies and procedures.
To that end, in recent years, the Department's Rural Interagency
Working Group has helped offices responsible for our programs,
including the Rural Education Achievement Program (REAP), collaborate
on issues such as access to broadband services which disproportionately
impacts rural schools and communities. Department staff are examining
how we can build upon these internal collaborations. Drawing on the
experience of other Federal agencies, the Department also plans to
collaborate more closely with the Departments of Agriculture, Interior,
and Health and Human Services to better support and serve students in
rural communities.
The Department interacts regularly with REAP grantees and
organizations advancing the interests of rural schools. The Department
appreciates input from rural stakeholders and is working toward being
responsive to that feedback. For example, in order to reduce burden on
rural local educational agencies (LEAs), the Department has simplified
the application process for the Small, Rural School Achievement (SRSA)
grant, under which OESE awards over 4,000 LEA grants annually. OESE
plans to increase its outreach to REAP grantees and its participation
in events organized by rural advocacy organizations such as the
National Rural Education Association (NREA). Additionally, the
Department has recently been in contact with the Organizations
Concerned about Rural Education (OCRE) regarding issues affecting rural
schools and communities and emphasizing collaborative efforts to
support rural schools.
The Department will continue to rely on local leaders and rural
stakeholders for their expertise and knowledge of rural schools, with
those conversations informing plans to support student achievement in
all settings.
Question. Across the nation, equitable access to effective teachers
remains an issue. Rural schools, especially, often struggle to recruit
and retain talented teachers and school leaders. Previous programs such
as the Transition-to-Teaching grant program provided for scholarships
for teacher preparation programs to meet the needs of schools with
demonstrated teacher shortages. In Mississippi, Transition-to-Teaching
grants awarded in the last decade led to the successful licensure of
hundreds of new teachers in the past 5 years, addressing the needs of
rural schools.
Please discuss how you envision the that the Department can
explicitly addresses inequitable distribution of effective teachers,
particularly in rural areas.
Answer. The Administration's fiscal year 2022 request provides both
flexible ESEA formula grant funding and competitive opportunities that
can help States and school districts carry out strategies aimed at
putting effective teachers in front of every classroom:
--The $20 billion increase proposed for the Title I program would
more than double the formula grant funding available to help
address under-resourced school districts while helping to
ensure that teachers in Title I schools, including thousands of
rural Title I schools, are paid competitively.
--The $2.1 billion requested for Title II will support ongoing State
and local efforts to improve teacher and principal
effectiveness and help ensure that all students have equitable
access to well-prepared, qualified, and effective teachers and
principals. In particular, States may use Title II-A funds for
programs that provide alternative routes for State
certification of teachers in areas where the State experiences
a shortage of educators, similar to the previously authorized
Transition to Teaching program.
--The $250 million request for IDEA Personnel Preparation, an
increase of nearly $160 million, would help ensure that there
are adequate numbers of personnel in underserved rural schools
with the skills and knowledge necessary to help children with
disabilities succeed educationally, including enhanced support
for beginning special educators.
--The $80 million requested for Supporting Effective Educator
Development (SEED) would support evidence-based educator
preparation and development efforts that can serve as models
for similar efforts across the country; new projects could have
a stronger focus on building and enhancing the instructional
skills of a more diverse educator workforce.
--The $200 million requested for Teacher and School Leader (TSL)
Incentive grants would support reforms to human capital
management systems and performance-based compensation systems;
the statue requires that priority be given to applicants that
support teacher and leaders in high-need schools; in addition,
consideration is given to ensuring an equitable geographic
distribution of grants, including equitable distribution
between urban and rural areas.
--The $30 million requested for first-time funding (since
reauthorization) of the School Leader Recruitment and Support
program would support grants for high-quality professional
development for principals, other school leaders, and aspiring
principals and school leaders. Under the first competition for
the program since the reauthorization of the ESEA, projects
would focus on ensuring that the nation's most underserved
schools have resources to improve school leadership.
--The $132.1 million request for the Teacher Quality Partnership
program, an increase of $80 million, supports projects that
improve the preparation of teachers, including through teacher
residencies and ``grow your own'' programs that can be
especially valuable in rural communities.
--The $20 million request for first-time funding of the Hawkins
Centers of Excellence program would support diversifying the
educator workforce, including in rural areas, by increasing the
number of high-quality teacher preparation programs at Minority
Serving Institutions.
Question. Rurally located and rural serving public colleges and
universities have an important role to play in the economic and social
recovery from the COVID-19 pandemic. Public institutions of higher
learning are important economic anchors in their communities and
provide important access to educational opportunities that drives rural
economies. However, rural colleges and universities are often
underfunded compared to more urban and suburban institutions of higher
learning, and students face particular challenges including geographic
access and access to broadband Internet and technology. This report on
the role that rural serving institutions play and Federal policy
solutions to strengthen rural anchor institutions https://
www.regionalcolleges.org/project/ruralanchor.
How will you work to enact policies and practices that strengthen
rural serving and rurally located public colleges and universities,
including HBCUs and other minority serving institutions, and the
communities they serve?
Answer. The Department, in general, provides funding to
institutions of higher education (IHEs) through two primary vehicles:
(1) formula-based institutional capacity-building grants, and (2)
discretionary competitive grants. For the Department's formula-based
institutional capacity-building grants, such as HBCUs, HBGI, PBIs, and
HBCU Masters, the Department has little flexibility given statutory
requirements to provide additional funding to rural IHEs. For
discretionary competitive grants, unless specifically prohibited by
statute, the Department generally can give priority to particular types
of institutions.
More broadly, rural-serving postsecondary institutions, include
HBCUs, would benefit significantly from key mandatory programs proposed
as part of the American Families Plan and now included in the Building
Back Better Act. These include Free Community College, which would
provide $108.5 billion over 10 years to create a new partnership with
States, territories, and Tribes to make 2 years of community college
free for first-time students and workers wanting to reskill,
potentially allowing up to 5.5 million students to pay zero in tuition
and fees for 2 years of community college; the Advancing Affordability
for Students program, which would award $39 billion over 10 years for
eligible 4-year HBCUs, TCUs, or MSIs to provide 2 years of subsidized
tuition for students from families earning less than $125,000; and
Completion Grants, which would provide $62 billion over 10 years for
grants to States and Tribes to support completion and retention
activities designed to ensure postsecondary success for low-income and
underserved students in high-need institutions.
______
Questions Submitted by Senator Patrick J. Leahy
Question. Even before the COVID-19 pandemic, Vermont was facing a
mental health crisis in its schools. Many students have been
irrevocably impacted by the opioid epidemic, losing parents and
caregivers. This trauma has had a negative impact on their mental and
behavioral health, leaving many teachers and school staff struggling to
deal with the consequences. This is why I am so pleased to see the new
$1 billion fund proposed by the administration to help schools hire
more counselors, nurses, and mental health professionals.
Unfortunately, Vermont is plagued with a severe shortage not only of
teachers but of mental health professionals. As of May 2021, there were
780 staffing vacancies among our mental health agencies in the state.
The number of kids seeking inpatient mental healthcare in Vermont
tripled between 2010 and 2019, as a dearth of community-based resources
has led many families no choice but to turn to the Emergency Room as a
last resort.
How does the administration propose to help schools, particularly
schools in rural areas, utilize this fund to hire school based health
staff in areas where there are community, or even statewide, shortages
of mental health professionals?
Answer. The School-Based Health Professionals proposal recognizes
the challenges to hiring such professionals in areas facing shortages,
and would allow State educational agencies to reserve up to 15 percent
of their allocations to address shortages of health professionals by
establishing partnerships with institutions of higher education to
recruit, prepare, and place graduate students in school-based health
fields in high-need LEAs and to complete required field work, credit
hours, internships, or related training as applicable for the degree,
license, or credential program of each health-based candidate. SEAs
also may use a portion of these funds for review and revision of State
licensure standards to promote mobility of health professionals into
school settings.We look forward to working with both chambers to ensure
this proposal provides adequate support for both hiring these key-staff
and developing the pipeline.
Question. I strongly support the administration's goal to increase
equity in public education funding. The COVID-19 pandemic has
particularly laid bare the systemic inequalities that exist in our
nation's schools. Vermont has many small and rural schools that have
historically struggled to close both the equity gap and the digital
divide due to a lack of resources. The proposed $20 billion for a new
Title I equity grant program would represent the most significant
Federal investment the program has ever seen. It is vital that this
grant program is an option for all schools that need it around the
country.
How will you ensure that these equity grants are distributed among
geographically diverse areas, particularly rural areas?
Answer. State educational agencies would allocate funds to school
districts based on existing Title I formulas, ensuring that virtually
all school districts--urban, suburban, and rural--receive significantly
more Title I funding to help close equity gaps in teacher compensation,
access to rigorous coursework, and access to preschool.
Question. TRIO and GEAR UP are vital student assistance programs
that helps first generation, disabled and low income college students
in Vermont succeed in all aspects of college life. These programs have
proven effective in increasing postsecondary enrollment and graduation
rates, as well as helping to address workforce shortages in the state.
Unfortunately, both the COVID-19 pandemic and a historical lack of
Federal funding for the programs has meant that many of the grant
application cycles have become highly competitive. For example, the
fiscal year 2020 TRIO Student Support Services (SSS) competition faced
a significant increase in applicants. Separated by mere percentage
points, 80 longstanding SSS programs were defunded, among more than 600
un-funded applicants. This left nearly 15,000 high-need students
without access to services provided by the program.
How does the administration propose to allocate the increase in
fiscal year 2022 funding for TRIO and GEAR UP? Will any of the funding
become eligible to programs that were defunded in the fiscal year 2020
SSS cycle?
Answer. The Administration recognizes that limited resources under
the TRIO and GEAR UP programs have historically resulted in an
inability to fund all high-scoring applicants. This is why the
increased funding proposed for TRIO in fiscal year 2022 would be
allocated, in part, based on historical trends in the programs
scheduled for competition in fiscal year 2022. Specifically, the
Administration reviewed peer review scores on all applications
submitted for fiscal year 2017 competitions under Upward Bound, Upward
Bound Math and Science, Veterans Upward Bound, and McNair
Postbaccalaureate programs (the last year in which competitions were
held under these programs also scheduled for competition in fiscal year
2022), and proposed to allocate additional funds to each program based
on the number of high-scoring unfunded applicants from that year to
ensure that funding more appropriately met demand. In addition, the
Administration has proposed to provide all grantees under the Student
Support Services program a 10 percent supplemental award to support the
critical services they provide our students. However, at this time
there are no plans to make additional Student Support Services awards
to applicants that were unsuccessful in the fiscal year 2020
competition.
Question. The Public Service Loan Forgiveness (PSLF) Program
forgives Federal student loan debt of borrowers who work for at least
10 years in qualifying public service employment. The program has been
plagued by complicated eligibility criteria and ongoing administrative
problems that have resulted in a dismal approval rate. I was pleased to
see the administration recently announce a regulatory review of PSLF
and other Federal student loan relief programs to understand how they
can better serve the needs of our nation's borrowers. However, the
President's Budget proposes a decrease in funding for PSLF.
Could you explain the justification for a 50 percent budget
decrease for PSLF? What progress has the agency made in addressing the
issues that have resulted in such a low approval rate for loan
forgiveness?
Answer. The Department recognizes that there are PSLF areas for
improvement and we are committed to addressing them as quickly as
possible so that our public servants receive the benefits they have
worked hard to earn. We have already made some improvements to make it
easier for eligible borrowers to access relief through administrative
actions and others are in store. For instance, the Department has
launched and updated the PSLF Help Tool, is now allowing lump sum and
prepayments to count as qualifying payments, and created a single
application for PSLF, Temporary Expanded PSLF (TEPSLF), and Employment
Certification Forms (ECFs). However, we recognize more needs to be
done. To that end, we recently announced that PSLF is among the topics
we intend to revisit through an upcoming rulemaking process. We also
recently issued a Request for Information, inviting feedback on
borrower experiences and possibly policy solutions with the PSLF
program, to identify broader areas for improvement.
At the same time, Congress has provided funds annually toward
TEPSLF so borrowers who may have made payments in a repayment plan not
previously eligible for PSLF could still qualify for relief. Though
these funds have remained largely unspent to-date, the Department still
requested additional funds for fiscal year 2022 in recognition of the
importance of this program to public servants. The additional $25
million the Administration requested will ensure even more borrowers
can access the program and receive relief under the TEPSLF program. In
addition to those funds, we are also working to improve administration
of the TEPSLF program and streamline access to its benefits; we believe
those improvements will lead to these funds being more easily awarded
to borrowers in the future.
SUBCOMMITTEE RECESS
Senator Murray. With that, this hearing is adjourned.
[Whereupon, at 11:31 a.m., Wednesday, June 16, the
subcommittee was recessed, to reconvene subject to the call of
the Chair.]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2022
----------
WEDNESDAY, JULY 14, 2021
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10 a.m. in room SD-138, Dirksen
Senate Office Building, Hon. Patty Murray (chairwoman)
presiding.
Present: Senators Murray, Reed, Shaheen, Merkley, Baldwin,
Blunt, Kennedy, and Braun.
DEPARTMENT OF LABOR
Office of the Secretary
STATEMENT OF HON. MARTIN J. WALSH, SECRETARY OF LABOR
OPENING STATEMENT OF SENATOR PATTY MURRAY
Senator Murray. Good morning. The Senate Appropriations
Subcommittee on Labor, Health and Human Services, Education,
and Related Agencies will come to order.
Today we are having a hearing on the Biden administration's
fiscal year 2022 budget request for the Department of Labor.
Senator Blunt and I will each have an opening statement. Then I
will introduce our witness, Secretary Walsh.
After his testimony, Senators will each have 5 minutes for
a round of questions. While we are unable to have this hearing
fully open to the public, or media for in-person attendance,
live video is available on our committee website. And if you
need accommodations, including closed captioning, you can reach
out to the Committee of the Office of Congressional
Accessibility Services.
VISION OF THE FISCAL YEAR 2022 PRESIDENT'S BUDGET
You know, a budget is a reflection of values and through
our hearings on President Biden's budget for the Department of
Health and Human Services, and the Department of Education, we
have seen a welcome change in values from the previous
administration, and the budget proposal for the Department of
Labor is no exception.
This budget is a message to workers across the country;
President Biden is fighting for you. Workers are the backbone
of our economy. When we invest in workers, in keeping them
safe, strengthening their rights, providing pathways for their
development, ensuring their financial security, and more, we
are investing in a stronger economy and a country for everyone.
And that is exactly what this budget, which proposes
increasing funding for the Department of Labor by 14 percent,
does. When it comes to workers' safety, this past year has been
a painful lesson on how important it is for every person to
have a safe workplace. But even before the pandemic, our Nation
saw 5,000 workplace deaths a year, one every 99 minutes. And
on-the-job deaths have disproportionately spiked for Black and
Latino workers since 2016, increasing 8 percent and 25 percent
respectively, compared to just 3 percent overall. And while we
know the economic cost of these deaths, a substantial $250
billion a year, the loss to families is immeasurable.
PROTECTING WORKERS AND THEIR WAGES
That is why the Occupational Safety and Health
Administration was founded 50 years ago, with the mission to
protect worker health and safety. President Biden's budget
would help us recommit to that mission by increasing OSHA's
(Occupational Safety and Health Administration) funding level
by 73 million from last year, and that will help the agency
hire more staff, provide more assistance to workers and
businesses, hold employers accountable to providing safe,
healthy workplaces, and ultimately save lives.
In addition to protecting workers' lives, this budget also
includes funding to protect their wages. It would provide
$276.5 million to the Wage and Hour Division, an increase of
$30 million. This agency investigates employer wage theft and
illegal compensation practices used to cheat people out of
their hard-earned wages, something which most commonly happens
to women, workers of color, and foreign-born workers. The Wage
and Hour Division recovers, on average, $1,120 per affected
employee. And they do it with a staff of barely 1,300 people
covering 148 million workers at over 10 million workplaces.
The funding in this budget would help them expand their
capacity, and put even more money back in the pockets of even
more workers who have been cheated by their employer. And
President Biden's budget not only invests in accountability for
employers in our country, but also in accountability for our
trading partners. So workers in Washington State, or Missouri,
or across the country, don't pay the price for unfair labor
practices across the world.
This budget increases funding for the International Labor
Affairs Bureau (ILAB) by over a quarter, including $19.16
million for ILAB to expand monitoring and enforcement of worker
rights under our trade agreements and preference programs, and
critical new investments to fight forced labor and child labor.
This budget also provides support to help workers
struggling in light of the economic crisis caused by COVID-19,
including the millions who have lost jobs, and especially
women, workers of color, and others who have been most set back
by it.
TRAINING AMERICA'S WORKFORCE
President Biden's budget would increase funding for
registered apprenticeships by $100 million, an increase well
over half of what its budget was last year.
These are proven apprenticeship models and lead to good-
paying jobs in high-demand fields. Funding for them will help
address long-standing inequities in apprenticeships, and change
the fact that women and workers of color are historically
underrepresented in these apprenticeship programs, and in the
careers that they lead to.
The budget would also increase funding throughout the
workforce training system, including with the $203 million
increase for workforce development State grants, which help
States make investments in career pathways for youth, and
support adults and dislocated workers, including those most
affected by the pandemic, and a new National Youth Employment
Program, and Veterans Clean Energy Training Initiative.
Secretary Walsh, I look forward to hearing more about your
plans here.
MODERNIZING UNEMPLOYMENT INSURANCE SYSTEMS
And finally, this budget includes funding to administer and
improve State unemployment insurance systems. This COVID-19
pandemic made really clear what a lifeline that support can be,
and how outdated and inadequate some of our systems are. This
budget would help modernize our unemployment insurance system,
and address vulnerabilities, inefficiencies, and other issues
with processing these critical benefits, so families can get
the support they need faster.
Of course, the need for better unemployment insurance
systems, workforce training programs, and workplace safety are
just a few of the many issues we have to tackle in the wake of
this pandemic.
EMPOWERING AMERICA'S WORKERS
If we want a stronger economy, if we want a stronger
country it all starts with stronger rights for workers. We also
need to make sure workers are safe from pandemics, sexual
assault, and harassment, and more. We need to make sure workers
have paid family, sick, and medical leave, quality, affordable
childcare, a livable minimum wage of $15 an hour, without
exceptions, and a secured retirement.
We need to make sure workers are not disadvantaged by pay
inequality. We need to address the inequities in our economy
that makes things so much harder for women, workers of color,
workers with disabilities, and others.
And we need to defend and strengthen the right to form and
join a union, a right, which allows workers to secure better
pay and benefits, and safer working conditions. This budget is
a bold step in the right direction. And my colleagues and I
have proposed other steps as well.
Secretary Walsh, I look forward to working with you and
President Biden in the months ahead to support workers in our
country.
With that, I will turn it over to Senator Blunt for his
opening statement.
STATEMENT OF SENATOR ROY BLUNT
Senator Blunt. Thank you, Senator Murray.
Good morning, Secretary Walsh. Welcome to the committee. I
look forward to your testimony today, and the chance to talk
about the Department's budget request for the coming year.
You know, the past 18 months have been challenging for our
country. The COVID-19 pandemic put unprecedented strain on the
economy, on its workforce, and on families who suddenly were
dealing with issues they hadn't expected to deal with, and that
families hadn't dealt with in the same way before.
Prior to the COVID-19 Public Health Emergency Declaration,
the unemployment rate was 3.5 percent. That was the lowest
since the late 1960s. I think you have to assume from that,
that some of the things that we are doing that were different,
were making a difference. But at the height of the pandemic, in
April of 2020, our unemployment rate exceeded 14 percent. While
we have made great strides in bringing our unemployment rate
back down since that point, I am concerned we won't reach the
3.5 percent pre-pandemic number due to, frankly, some misguided
Federal policies, specifically the additional $300 in Federal
supplemental unemployment payments that have unintentionally
incentivized unemployed individuals to remain exactly that,
unemployed.
In May of this year, the weekly--the average weekly
unemployment check in the country was $318. That is a bigger
check than a lot of people had taken home before, and you
didn't have the expenses of going to work. And so frankly, a
lot of people did not go to work. While businesses in America
have been searching for workers, this benefit has really
misaligned the workforce needs across the Nation.
And in Missouri recently, I continue, to see ``Help
Wanted'' signs all across the State, and in my hometown of
Springfield, these help wanted signs often included hiring
bonuses, and pay well above the $10.30 minimum wage in our
State. Missouri, like many States across the country, has
decided to end the Federal supplemental payment to increase the
level of participation in the economy.
I believe that it is beginning to work, but I also believe
it is now time for Congress to recognize the importance of
balancing, providing a safety net when you need it, and
ensuring that our labor needs are met. We need to create an
environment for Americans to thrive, where people want to go
back to work, where they are encouraged to go back to work, and
where people who can't go back to work have a basic
unemployment benefit.
However, I am concerned that some of the components of the
Department's budget request, and particularly some of the
increases, don't consider this, or the very real needs of local
communities, and the needs for a workforce to be more actively
engaged. Really, too much of this budget is driven by the
politics of the administration. Now every administration
should, and has every reason to make some changes. I think this
budget makes way too many changes, in way too short a time.
For example, instead of focusing funding on flexible
workforce training, determined by States to meet their own
unique employment needs, the administration is tying training
funds in many, many cases to green jobs. I am not opposed to
green jobs. I am just opposed to the Federal Government
deciding how States approach the needs they have right now.
According to the analysis of the U.S. Energy and Employment
Report, and the Department of Labor's Bureau of Labor
Statistics, when compared to jobs in fossil fuels, jobs in
solar, and wind power, employ a larger share of individuals in
their construction, rather than more permanent roles, as plant
managers, and other jobs. These jobs don't pay enough, and are
unionized at lower rates.
Mr. Secretary, I agree with you, and we have talked about
this, that we really need to target funding to the workforce of
the future. However, I think it is unlikely that the Federal
Government alone will be able to figure out what that workforce
of the future should look like. And we need to have more
involvement from States, communities, and local economies.
Now, we are going to disagree on some things in this
budget, but I am encouraged to see things we are going to agree
on. For instance, the increase of the apprenticeship program, I
think this has been, and needs to continue to be a successful
tool to allow workers to get paid while they train. And
frankly, to find out as early as possible, if what they think
they want to do is not meeting their expectations. So they
don't get way too far down a line before they realize, this is
not what I want to do.
This budget supports programs that are targeted to the
hardest hit parts of the country. For instance, the Appalachian
and the Lower Mississippi Delta regions have challenges there.
And I think your budget does what it needs to, to begin to
allow us to look at those challenges; there is support here for
veterans transitioning to civilian workforce, one of the key
priorities of this committee, and I think of this Congress.
Mr. Secretary, we are in a challenging environment. It is
going to be a difficult year. I believe we can work toward
consensus with the Department's budget, but frankly, as I have
said at our other budget hearings this year, I think this can
only be achieved by more parity between the defense and
nondefense funding. The President's budget request did not
achieve that goal. However, I remain confident that the final
appropriations bill will.
And Mr. Secretary, I am glad that you plan to be in St.
Louis tomorrow. I know we were told yesterday a couple of the
things you would be talking about: one, promoting vaccines, and
the other, the Job Corps. On the vaccine front, I was talking
about this at our leadership stakeout yesterday. I have talked
about it I think in every event I have been in in Missouri
since we started the Warp Speed effort to try to get vaccines
available more quickly.
Vaccines are a necessary, an absolutely necessary part of
us creating an environment where this virus can't continue to
replicate itself and change in new ways, and the variants are
going to be the future enemy. Vaccine is the answer to those
variants.
On Job Corps, Senator Murray, and I, and the committee have
worked together the last 6 years to increase that funding. I
know those programs continue to be programs that we can do more
with and, can look for reforms in. And I look forward to your
leadership in that area.
So again, thank you for your time here today. I look
forward to working together, as we try to be sure that
Americans, working families, have the opportunities they need,
and that our economy continues to grow. Thank you, Senator.
[The statement follows:]
Prepared Statement of Senator Roy Blunt
Thank you, Chair Murray. Good morning and welcome, Secretary Walsh.
I look forward to your testimony on the Department of Labor's fiscal
year 2022 budget request.
The past 18 months have been challenging for our nation. The COVID-
19 pandemic put unprecedented strain on our economy and its workforce.
Prior to the COVID-19 public health emergency declaration, the
unemployment rate was at 3.5%, the lowest since the late 1960s. At the
height of the pandemic, in April 2020, our unemployment rate exceeded
more than 14%. While we have made great strides in bringing our
unemployment rate back down since that point, I'm concerned that we
won't reach that 3.5% pre-pandemic number due to misguided federal
policies.
Specifically, the additional $300 in federal supplemental
unemployment payments have unintentionally incentivized unemployed
individuals to remain exactly that: unemployed. While so many
businesses in America are searching for workers, this excessive benefit
seems misaligned with the workforce needs across the nation.
When I was in Missouri recently, I saw ``help wanted'' signs across
the state. In my home town of Springfield, these ``help wanted'' signs
included hiring bonuses and pay well above the $10.30 minimum wage in
the state. Missouri, like many states across the country, has decided
to end the federal supplemental payment to increase the level of
participation in our state's economy. And I believe it is now time for
Congress to recognize the importance of balancing providing a safety
net, when needed, with ensuring that our labor needs are met.
We need to create an environment for Americans to thrive--where
people want to go back to work, where they are encouraged to go back to
work, and where people who can't go back to work have a basic
unemployment benefit. However, I am concerned that some components of
the Department of Labor's budget request, and particularly some of the
increases don't consider this or the very real needs of the local
communities. Instead, too much of the budget is engrossed in the
politics of this Administration.
For example, instead of focusing funding on flexible workforce
training determined by states to meet their own unique employment
needs, the Administration is tying training funds to ``green jobs.''
Yet, according to an analysis from the U.S. Energy and Employment
Report and the Department of Labor's Bureau of Labor Statistics, when
compared to jobs in fossil fuels, jobs in solar and wind power employ a
larger share of individuals in their construction rather than in more
permanent roles as plant operators; these jobs also don't pay as much,
and are unionized at lower rates.
Mr. Secretary, I agree with you that we should target funding to
the workforce of the future. However, I think it's wrong for the
federal government to dictate what that workforce should look like, and
for bureaucrats in Washington, DC to determine the speed at which we
get there. That should be left up to states, to communities, and to
local economies.
While we may disagree on this point, there are many components of
the budget request on which we do agree. I'm encouraged to see an
increase for the Apprenticeship Program--which has been a successful
tool to allow workers to get paid as they train--support for programs
targeted to the hardest hit parts of our country--in the Appalachian
and Lower Mississippi Delta regions--and support for our veterans
transitioning to the civilian workforce.
Mr. Secretary, we are in a challenging environment and this is
going to be a difficult year. I believe we can work toward consensus
with the Department's budget, but as I have said at other FY2022 budget
hearings this year, this can only be achieved when there is parity
between defense and non-defense funding. The President's budget request
did not achieve this goal. However, I remain confident that final
appropriations bills will.
Thank you for your time here today. I look forward to working with
you to strengthen our nation's workforce and create a more prosperous
economy for all Americans. Thank you.
Senator Murray. Thank you, Senator. Thank you.
And with that, we will turn to Secretary Walsh. Welcome to
our committee. And you may begin your testimony.
SUMMARY STATEMENT OF HON. MARTIN J. WALSH
Secretary Walsh. Thank you very much, Chairwoman Murray, I
appreciate it; and Ranking Member Blunt, and the members of the
subcommittee, thank you for having me today.
I look forward to aligning the Biden-Harris
administration's version of the Department of Labor's fiscal
year 2022 budget and beyond. And I am excited to be here in
person. This is my second in-person hearing. My first was my
confirmation. So if I make some mistakes, bear with me until I
get used to this process. So I truly appreciate it.
I want to just start by saying how humbled and honored I am
to be here, as the son of Irish immigrants, and a member--my
father was a member of the Labors Union in Boston, to lead the
Department of Labor. Just to think about their journey to
America, and having their son sitting in front of Congress--in
front of the Senate today.
I also believe, as the President says, we are at an
inflection point in our Nation's history right now. We are
coming out, as was mentioned a couple of times, of a pandemic
that has taken over 600,000 American lives. And it has pushed
working people to the breaking point in so many different ways,
in so many different corners of our country.
The President and Congress worked together to pass the
American Rescue Plan. It changed the course of the pandemic. It
delivered relief to the American people, and it certainly set
us on a pathway to recovery. At the Department of Labor, the
team over there is working hard to implement this plan, from
strengthening our unemployment systems to fully subsidizing the
corporate premiums, to protecting workers' health and safety.
But there is certainly much more work to be done. We need
to build back better. That means putting workers at the center
of a more resilient, more inclusive, and ultimately more
competitive economy as a country. That is what the President's
economic vision is all about.
The Bipartisan Infrastructure Framework negotiated with
members of the Senate would rebuild our communities and create
millions of good jobs all across this country. And the Build
Back Better agenda would make historic investments in working
people through job training, and education, which I think we
can all agree on, the CARES economy, and paid family leave, and
medical leave, and workers' rights and protections.
BUDGET INVESTMENTS
Building on that vision, the Department of Labor's fiscal
year 2022 budget request proposes an investment of $14.2
billion. That is, as the Chairwoman mentioned, a 14 percent
increase over 2021 enacted levels. That includes $3.7 billion
in Workforce Innovation and Opportunity Acts, and the Wagner
Peyser state formula grants. It is an increase of 6 percent.
That is about creating more pathways to good-paying jobs for
workers who need them the most. And we have seen it with people
unemployed now, and underemployed, the opportunity to make
those investments.
This budget also would invest $285 million in registered
apprenticeship programs. That is an increase of $100 million
that would allow us to expand and diversify a model of economic
mobility that has proven to produce results for both workers
and employers all across this country.
For unemployment insurance, we would fully fund and update
the formula for what States receive to administer UI
(Unemployment Insurance), it is the first update, quite
honestly, in decades. We also request $100 million for
technology solutions to prevent fraud and ensure access to UI
benefits for all people that need them.
For our worker protection agencies, this budget requests
$2.1 billion, a 17 percent increase. We need to rebuild and
strengthen our capacity to protect workers, wages, benefits,
and rights, and safety on the job sites.
This budget also requests $100 million for the multiagency
POWER Plus Initiative that is aimed at empowering displaced
workers in coal communities with new--with new skills and new
job opportunities. And it requests $20 million for a new
program to help veterans. The ranking member mentioned this. It
is transitioning services for members and military spouses to
get good careers in clean energy.
It was developed with the Department of Labor--with the
Department of Labor's Department of Veterans Affairs. Across
the Department of Labor's work, this budget invests in those
who have been shut out of economic opportunities in the past,
from women, and people of color, to rural Americans, and
veterans, to at-risk youth, justice-involved adults, and people
with disabilities.
The pandemic proved that the systems failing some workers
end up failing all workers, and failing our country,
ultimately. But we have an opportunity to do better now, coming
out of the pandemic. We can empower all American working
people. It is a moment in history when we need to move forward
together, we need to come together.
Madam Chairwoman, Ranking Member, thank you for the
opportunity; I know that we will have many more conversations,
and we will work together to support the economic recovery that
works for all American workers.
I look forward to discussing the budget proposals and
requests with you and the committee today. And I am happy to
respond to any questions that you have. And if I do not have an
answer to your question, I guarantee you our team will get back
to you in the next couple of days with questions--answers that
I don't have today. So thank you.
[The statement follows:]
Prepared Statement of Martin J. Walsh
Chairwoman Murray, Ranking Member Blunt, and members of the
Subcommittee, thank you for the invitation to testify today. I am
pleased to appear before this Subcommittee for the first time and to
outline the Biden Administration's vision for the Department of Labor
in Fiscal Year (FY) 2022 and beyond. I am honored and humbled to lead
the Department in its critical work.
The Department's mission is to foster, promote, and develop the
welfare of the wage earners, job seekers, and retirees of the United
States; improve working conditions; advance opportunities for
profitable employment; and assure work-related benefits and rights.
This mission is personal to me and my family's story. My father's
participation in the Laborers Union, Local 223 in Boston, was the
pathway to a fair wage, so my family was not worried about housing
insecurity. My parents had a safe workplace, so I never knew the fear
of them not returning from work. The job came with a pension, so my
parents could retire with dignity. And the job included health
insurance, so that when my parents experienced the worst nightmare of
having a child diagnosed with cancer, they had health insurance so that
I could be treated and recover.
Years later, I followed my father into construction and joined the
same union, and experienced those same benefits of having a safe
workplace, health insurance, a fair wage, and a pension. These are not
abstract policies--these are life-changing rights. I have spent my
career fighting for the rights of working people as a State
Representative, as General Agent for the Metro Boston Building Trades
Council, and as Mayor of Boston. I feel privileged to continue this
work as the Secretary of Labor.
american rescue plan
As a former Mayor, I know that our communities--and our families--
have been hit hard by the COVID-19 pandemic. That's why it was so
important that Congress worked with President Biden to pass the
American Rescue Plan (ARP) to change the course of the pandemic and
deliver immediate relief for American workers. In terms of jobs, not
only did the ARP extend unemployment insurance benefits for our friends
and neighbors who lost their jobs during this pandemic, but it also
laid the groundwork for shoring up and modernizing our unemployment
insurance system to help workers get the benefits they deserve when
they need them. The ARP also helps workers who lost their jobs or had
their hours reduced pay for health insurance by fully subsidizing COBRA
premiums for eligible individuals from April 1 through September 30 of
this year. And it provides additional funding for the Department to
help keep vulnerable workers healthy and safe. Finally, ARP also
distributes more than $360 billion in emergency funding for state,
local, territorial, and Tribal governments to ensure that they are in a
position to keep front line public workers on the job and paid, while
also effectively distributing the vaccine, scaling testing, reopening
schools, and maintaining other vital services. We appreciate this
landmark law, and we are working hard to ensure that this law is
implemented in the way that Congress and the President intended to
reopen our economy.
american jobs plan
As a former construction worker, I know a good job can change your
life. One of the most important things we do at the Labor Department to
improve the economy and strengthen the workforce is help people pursue
training that leads to good jobs and helps close racial and gender
equity gaps throughout the economy. The President's American Jobs Plan
is a historic investment in the working people of America. It will
create millions of good paying, family sustaining jobs that rebuild the
middle class by empowering our workers to build America's future.
The President's plan provides funding for sector-based training
programs focused on growing, high-demand sectors, such as clean energy,
manufacturing, and caregiving, helping workers of all kinds to find
good-quality jobs in an ever-changing economy. In addition, the plan
provides for a new Dislocated Workers Program that provides
comprehensive supports for workers who have lost jobs through no fault
of their own, to ensure they are able to successfully participate in
training that can prepare them for in-demand jobs. The plan will
prioritize workforce development opportunities for underserved
communities and ensure job opportunities are open to, and support,
women, people of color, people with disabilities, and people impacted
by the criminal justice system, among other disadvantaged groups.
Further, subsidized jobs programs will support unemployed and
underemployed workers who have faced significant barriers to employment
to gain a key foothold in the labor market. Additional investments to
establish more pathways to good jobs include creating up to two million
new registered apprenticeship slots, while strengthening access for
women, people of color, and individuals with disabilities; creating
career pathway programs in middle and high schools, including those
that increase access for underrepresented students to computer science
and other STEM sectors; and supporting community college partnerships
that build capacity to deliver job training programs that lead to good
jobs. The plan also makes key investments in expanded career services
and adult literacy programs to equip job seekers with the tools,
information, and foundational skills they need to be successful in the
labor market.
The plan provides critical funding to strengthen the capacity of
our labor enforcement agencies to prevent discrimination, protect wages
and benefits, enforce health and safety rules, and strengthen health
care and pension plans. In addition to these investments, the President
is calling for increased penalties when employers violate workplace
safety and health rules, which have proven inadequate to address
serious violations.
fy 2022 budget: supporting america's workers through the pandemic to
recovery
Building on the American Rescue Plan and the American Jobs Plan,
the Department's FY 2022 budget proposes investments in workers and in
our country's future: a future of opportunity and shared prosperity, a
future of robust job growth and a thriving middle class, a future where
workers nationwide get the skills and training that leads to jobs that
pay a fair wage without risking their health or safety. The
Department's budget requests an investment of $14.2 billion in
discretionary resources, which is a 14 percent increase above the FY
2021 enacted level.
The budget includes resources to expand training opportunities,
supporting workers and building a better future. There is no single
path to a good-paying job, and the country's future growth and
prosperity depend, in part, on ensuring workers have multiple pathways
to high-quality, good-paying jobs. To that end, the budget requests
$3.7 billion, a six-percent increase, for the Workforce Innovation and
Opportunity Act and Wagner Peyser state formula grants to make
employment services and training available to more dislocated workers,
low-income adults, and disadvantaged youth hurt by the economic fallout
from the COVID-19 pandemic.
The budget also invests additional resources in programs that serve
marginalized groups, such as justice-involved individuals, at-risk
youth, and vulnerable veterans. While higher-income earners have
recovered many of the jobs lost, workers in low-wage industries have
experienced persistent net loss. As seen in the June 2021 Employment
Situation, disparities among workers continue, and over 5.7 million
jobs that existed last February are yet to return. While the overall
unemployment rate was 5.9 percent, the African American unemployment
rate was 9.2 percent and the Hispanic rate was 7.4 percent, compared
with 5.2 percent for Whites. For individuals with disabilities, the
unemployment rate was 10.9 percent. Due in large part to the impact of
the pandemic, there are roughly 3.4 million fewer women working now
than there were in February 2020--and many women have had to reduce
their hours, often in response to caregiving demands. Women,
particularly women of color, continue to face barriers to good jobs
with equal pay. The budget prioritizes investments in these communities
of color, with a goal of increasing success for all groups, because
systems that are failing these populations are failing us all.
The Department will continue to invest in proven approaches, such
as expanding the Registered Apprenticeship model by investing $285
million, an increase of $100 million, which will allow the Department
to create a more balanced apprenticeship portfolio, support states'
efforts to implement a reauthorized National Apprenticeship Act, and
further the development of youth apprenticeship and pre-apprenticeship
opportunities, all while increasing equity for under-represented
populations. Registered Apprenticeships provide a pathway to good-
paying jobs, and as Secretary of Labor, I am committed to expanding
these opportunities across the United States, in order to help rebuild
the middle class and create millions of new opportunities for workers
to enter into relevant, high quality training that both protects
workers' rights and propels workers into career paths that provide a
sufficient and fair wage. Registered Apprenticeships produce strong
results for both employers and workers. The Department's investments in
Registered Apprenticeship will work to address the systemic disparities
that have impacted women, people of color, and other under-served and
under-represented populations.
This last year has again demonstrated that Unemployment Insurance
(UI) is an essential social insurance program and economic stabilizer,
and it has been a lifeline to millions of workers and to the economy
throughout the pandemic. Yet the pandemic uncovered longstanding
problems in the UI system, including the challenges facing states'
administration of their UI systems. These systems, in part as a result
of persistent underfunding and inadequate technology, have been plagued
by delays and obstacles that disproportionately affect workers of
color. When benefits are slow to reach workers who have lost their
jobs, it delays both their recovery and negatively impacts the country.
To address these challenges, the budget provides resources to ensure
States can better handle higher volumes of claims and be better
prepared for future crises or high unemployment levels. The budget
request fully funds and updates the formula for determining the amount
states receive to administer UI--the first comprehensive update in
decades. In addition, the budget requests $100 million to support the
development of information technology solutions that can be deployed in
states to ensure timely and equitable access to benefits. The $100
million increase will further support and complement the resources the
Department was appropriated under the American Rescue Plan to prevent
fraud, promote equitable access, and ensure timely payment of benefits.
The Biden-Harris Administration has taken stock of the challenges
the unemployment system faces and developed a set of high-level
principles that should guide future efforts to reform the UI system.
Those principles include ensuring adequate benefit levels and duration
for unemployed workers; ensuring the UI system can ramp up quickly and
automatically in response to recessions; addressing the lack of access
to UI for workers misclassified as independent contractors, low-income
and part-time workers, and workers with non-traditional work histories;
shoring up UI trust funds; and improving UI program access and
integrity.
The budget request includes $2.1 billion--a 17 percent increase in
funding--for our worker protection agencies, enabling the Department to
conduct the enforcement and regulatory work needed to ensure workers'
wages, benefits, and rights are protected, address the
misclassification of workers as independent contractors, and improve
workplace safety and health. These are the staff who recover back wages
owed, help prevent fatalities and life-altering injuries or illnesses,
respond to whistleblower complaints, reduce exposure to cancer-causing
agents, help ensure retirees get their benefits, and address pay
inequities.
Over the past four years, the Department's worker protection
agencies have lost 14 percent of their staff. A lack of enforcement
makes workers more vulnerable to workplace violations. The President's
budget reverses this trend by proposing $304 million in additional
funding for the Department's worker protection agencies, including $73
million for the Occupational Safety and Health Administration, $67
million for the Mine Safety and Health Administration, $35 million for
the Office of Federal Contract Compliance Programs, $31 million for the
Wage and Hour Division, and $37 million for the Employee Benefits
Security Administration.
The budget continues the President's commitment to tackling the
climate crisis. For the Department, the request includes an additional
$100 million investment in an initiative as part of the new Interagency
Working Group on Coal and Power Plant Communities and Economic
Revitalization, aimed at reskilling and reemploying displaced workers
in legacy energy communities. The request also includes $20 million for
a new discretionary program, developed in collaboration with the
Department of Veterans Affairs, which is focused on helping
transitioning service members, veterans, and military spouses to pursue
careers in clean energy, which will help combat climate change, while
preparing this population for good-paying jobs.
I know we will have a lot of conversations, as we collaborate on
the American Jobs Plan and the FY 2022 Budget. I look forward to those
collaborations and partnering with you all to invest in the nation's
economic recovery. The Department plays an important role in expanding
opportunity.
Madam Chairwoman, Ranking Member, thank you for the opportunity to
testify. I look forward to discussing our budget request with the
committee, and I am happy to respond to any questions you may have.
Senator Murray. Thank you very much, Mr. Secretary. We will
now begin a round of 5-minute questions of our witness. I ask
our colleagues to please keep track of your clock and stay
within your allotted time.
OSHA INCREASES IN THE AMERICAN RESCUE PLAN
I appreciate that the budget addresses the need to rebuild
and strengthen the capacity of the occupational safety and
health administration. Under the previous administration, OSHA
didn't do more than issue non-binding guidance on how employers
could protect workers from COVID-19. And that left a lot of
workers exposed, as we witnessed thousands of deaths and
illnesses of workers in healthcare, and meat packing, and other
essential industries.
Now, the Biden administration recently issued an Emergency
Temporary Standard, but it does not yet cover all frontline
workers. And as you know, OSHA received $100 million in the
American Rescue Plan, which it plans to use to support more
than 80 compliance and safety health officers, among some other
priorities. But as the economy continues to reopen, and more
contagious COVID variants emerge, workers need OSHA to be fully
engaged in its job of making sure employers provide a safe
workplace for their employees, and their workers.
So I wanted you to describe for the committee this morning,
your plans to use those ARP (American Rescue Plan) funds to
hire the staff OSHA needs to do its job, and how quickly do you
expect to get these staff on the job.
Secretary Walsh. Thank you very much, Madam Chair. OSHA is
one of the areas that, when I was sworn in, work had already
begun there, due to the help of the American Rescue Plan, and
investments in staffing up. They were severely understaffed to
be able to make sure that we keep our workplaces safe in
America. Certainly, we have a difficult time keeping up with
the average volume of business, but if you throw COVID-19 and
the atrocities of some of the workplaces in our country with
COVID-19, it made it very complicated.
We are currently in the process of hiring up and staffing
up in OSHA so that we can have more inspectors to go out to job
sites. Quite honestly, I would love OSHA, at some point--we are
asking for an increase in this budget--I would love OSHA at
some point to get to a point where we are not responding to
accidents on the job site, that we are actually being proactive
working with businesses, in how do we create better, safer work
conditions, and work sites.
We are not at that point right now, so we are at the point
where we are still looking to staff up, and hire up. And also
just--and I have spent many, many hours on Zooms with the OSHA
employees across the country, just thanking them for their
work, because throughout the pandemic OSHA employees went to
work every day. They didn't have the luxury of sitting home on
a Zoom and doing their job. They had to be on a job site. They
had to be touring facilities, and they had to see some of the
toughest situations out there. So I look forward to working
with this committee and continuing the staffing up of OSHA.
OSHA INCREASES IN FISCAL YEAR 2022 BUDGET
Senator Murray. Well, the budget requests an increase of
$73 million for OSHA in fiscal year 2022. Can you describe why
those funds are needed in addition to the ARP funds that were
provided?
Secretary Walsh. Yes, because--thank you. With the ARP
funds as it just--it restores us back to where we were pre-5-
years-ago. What the new funds allow us the opportunity to do is
expand the office and to get into some of the other work that
we want to do. People should not be, businesses should not look
at OSHA as a burden. People should be looking at OSHA as a
partner, and being able to create opportunities to help create
safe work environments.
When I was a young person working on construction sites,
and OSHA came on the job, they would come on the job to
investigate, but they were not investigating after an accident
happened, they were not investigating after a tragedy happened,
they were making sure that there were proper procedures in
place there to make sure that workplaces are safe.
We need to do work around this country to make sure that
our workplaces are safe, that workers are safe. And that we
collectively work with businesses as well as we move forward
here. So that additional revenue will go into continuing to
hire up in OSHA, and to create better opportunities to
training, and to have the best prepared--OSHA inspectors we
have in the country.
Senator Murray. You didn't mention whistleblower
complaints, but I understand that last year the inspector
general reported a significant increase in complaints, and
insufficient staff to investigate those complaints. What are
you going to do to address that issue?
Secretary Walsh. Again, it is about the staffing when--I
might have the numbers wrong--let me just get the numbers here
for you. We are going to double the number of inspectors by the
end of the administration, the first administration, Biden-
Harris administration, the first term, we are about--we were at
about 360 inspectors in the country, inspecting about 170
million workers in our country. That certainly is not going to
do the job.
So what we are doing here is making sure that we have
enough inspectors out there that when an employee calls the
office with a complaint, we are able to respond to that, and
not have it sit in a pile, or sitting in an inbox somewhere.
And again, it is about when you think about whether it is OSHA,
Wage and Hour, the Department of Labor was down about 3,000
employees to where it was 4 years ago.
And when you are down employees in the Department of Labor,
the Department of Labor is an agency, as you know, that is out
there protecting workers. If we don't have the staff and don't
have the employees to protect the workers, then we can't be on
the job sites, we can't be checking Wage and Hour, we can't be
making sure that people are working in safe conditions.
So our intention, with this investment that we are asking
for today, and with the intention of the American Rescue Plan,
to staff back up, to build back pre-4-years-ago level, but also
enhance that.
Senator Murray. Okay. I have a number of other questions,
and I am going to ask them at the end, so our other committee
members can have their time.
I will turn to Senator Blunt.
CREATING A WELL-PREPARED WORKFORCE
Senator Blunt. Thank you, Chair. Let me start with a
question that is really going to be more of a question I will
follow up with later, but I want to be sure we cover this. You
and I have talked about this before, Mr. Secretary, the idea
that people don't get the information they need early enough to
decide what kind of job is out there, what their personal sense
of job satisfaction would be, and what those jobs pay.
A few years ago I went with the Secretary of Labor to the
Carpenter Training facility in St. Louis, and as we visited
individually, the people, at the end of that visit, they were
all in their late-20s; they all had a similar story, and it was
sort of that lost decade of not knowing what they wanted to do,
or not having information about the importance of benefits, the
importance of job satisfaction.
And we have looked at that as sort of a lost decade that we
would like to avoid. It is hard to recover, frankly, from that
lost decade. You ask for $10 million to continue to pursue that
in your budget. The Secretary of Education didn't ask for the
$10 million education had last year. We put $10 million in both
budgets.
At some point when you have had time to think about this
more, I am going to ask you, I will be asking the Secretary of
Education what the two of you are doing to try to close that
gap between getting the information you need. If you want to
talk about the importance of knowing what jobs are out there
sooner rather than later. Just let me let you do that for a
moment.
Secretary Walsh. No. Thank you, ranking member. And to be
quite honest with you, I want to ask--add another component to
that: the Secretary of Commerce. So the Secretary of Commerce,
Gina Raimondo; the Secretary of Education, Secretary Cardona,
and myself, have had conversations. And when you think about
the jobs of the future, the three of us, the three of our
departments catch people--catch employers in educational
opportunities to prepare people for the future.
So what we are doing is, we are working collectively
together to make the investments. Gina Raimondo is working with
the business community as well as I am, to find out where the
gaps are, where they need employers--employees now, and in the
future, working with education on how do we create those
programs in our primary schools, in our high schools? How do we
create those opportunities in community college moving forward?
And the Department of Labor is offering--obviously has the
workforce development grants, and the workforce grants to be
able to fund those jobs. So it really has to be real
intentional work that we are doing here to make sure that this
money that we are asking for today, and the money through the
rescue plan, and potentially, through the CARES Economy Plan,
that this investment is preparing workers of the future.
ADAPTING TRAINING PROGRAMS TO MEET INDUSTRY NEEDS
You just said it yourself. I mean, when you think back and
look at the history of this country, and you look at the
investments that were made in the '50, and '60s and '70s, lots
of schools around America had training--had Vo-Tech schools,
and they were doing Vo-Tech training, and young people that
were going to those programs were going into the trades. That
would become an electrician, plumber, carpenter, laborer, and
mechanic, what have you.
Many of those programs are very different today. And I
think we are at a moment in time, coming out of a pandemic, or
getting through a pandemic, I should say--we are not out of it
yet--that we have an opportunity right now to retrain and
reskill workers, young people, as well as some older workers as
well, into those careers. But it has to be a coordinated
effort, it has to be the secretaries of commerce, labor, and
education, and it has to be Democrats and Republicans, quite
honestly.
Senator Blunt. All right. I am going to run out of time
here. I agree with that, but the component I want to be sure we
continue to add is like those Vo-Tech programs.
I was at a great new facility in Buffalo, Missouri, the
other day that they are building, and being focused again,
people need to know, sooner rather than later, what jobs are
out there, what those jobs pay. A lot of jobs that have that
kind of training actually produced greater satisfaction and
more income than jobs that you have a college degree for. And
sharing all that information early is important.
One way to create an early sense of what you want to do are
apprenticeships. Missouri, where you will be tomorrow, is
ranked second in the United States in apprenticeships. We are
working toward a goal in our State of having 20,000 active
apprenticeships by 2025. The one thing left out of that, it
appears to be the nontraditional industries and what we can do
to develop apprenticeships outside of the well-run trade union
programs, and other programs. For instance, like healthcare,
cybersecurity, even finance. What can we be doing to think
about how we expand that apprenticeship opportunity to new
fields?
Secretary Walsh. Well, what I have been doing, and what we
are going to continue to do is talk to companies, the tech
companies as well. We have opportunities in tech, and biotech,
and high-tech, and even pharmaceuticals. So having
conversations with those industries on how we create pathways
into those industries would be important. Those are good-paying
jobs, and they are looking for people.
And quite honestly, we have a huge opportunity right now in
this country to really think about those apprenticeships, and
how do we create more apprenticeships; and the beauty is--I
know my time is over--the beauty is, is the apprenticeships you
are paying while you are learning. And that is the difference
between workforce development and job training. You are
actually getting paid in the apprenticeship while you are
learning on the job.
Senator Blunt. Right.
Secretary Walsh. And that allows a person that might be
unemployed or underemployed right now, to get on-job
experience, real-life experience moving forward.
Senator Blunt. Thank you, Secretary. I will have some more
questions also later, Chairwoman. And thank you for the time.
Senator Murray. Thank you.
Senator Reed.
SHORT-TERM COMPENSATION PROGRAM
Senator Reed. Thank you very much, Madam Chairwoman.
And congratulations, Secretary Walsh, I am glad you are
there in the Department. Let me raise the first question about
the Short-Term Compensation Program, or otherwise known as
``work sharing''. After the last recession in 2010/2009, it is
estimated that we saved 570,000 jobs. And I know Congress and
the Biden administration stepped up and they are providing
fiscal support for this program, and it is saving tens of
thousands of jobs.
And as you know, what it does is it basically provides 1 or
2 days on unemployment compensation while the individual works
at the facility. Can you explain how, and if you will continue
to support this program, and try to extend it to every State in
the union?
Secretary Walsh. Thank you very much, Senator. And thank
you for raising this issue. Work sharing certainly is an
important and innovative tool. I agree with you, and I wished
that we had seen it across the States, and we want to see it
across the States. I think it is going to be very important for
the future of our workforce. It is important that we continue
to explore that. I am going to, as Secretary of Labor; our
Department is. The Department is certainly committed to
promoting State adaptation of this program.
And we are going to continue to find ways to increase
awareness and participation in the program. We have seen--you
have seen the benefit of it, and I think that--and workers are
seeing the benefit of it. And I think that those are
opportunities for us throughout the United States of America
for other States, and other workers, more honestly, to see the
benefit as well.
So I know that, Rhode Island, they have been a leader on
this, and I want you to know that I want to continue to work
with you, and maybe some of the other members of the Senate, in
governance, quite honestly, around the country to expand the
program.
DEMAND-DRIVEN TRAINING PROGRAMS
Senator Reed. Thank you, Mr. Secretary. Switching gears a
bit, I secured about $28 million in the Defense Appropriations
Bills for a submarine, industrial-based support of workers, and
of training, and education initiatives. And I think you have
seen one of these when you visited Westerly, Rhode Island, and
saw our training program, where our Department of Labor,
together with Electric Boat collaborates. And I think this is
another example of what Senator Blunt was getting at. This
demand-driven model for training, it is not the old-fashioned:
We turn out X, we have always done that. It is: What does
business need?
And up in our place where Electric Boat, over the next
several years, is going to have to hire 17,000 people, many of
them machinist, welders, et cetera. So how are you going to
continue to work with the Department of Defense to support
programs like this, and with other agencies to support demand-
driven programs?
Secretary Walsh. Well, first of all, thank you for your
work on this. Ranking Member Blunt talked about this as well. I
think first I want to say is that, the jobs that you work with
your hands are now computer jobs, meaning that you have to have
not just the skill to be able to be the craft person working
with your hands, but you need to be able to learn and read off
a computer because the work has gone so technical.
The Department of Labor has just awarded the State of Rhode
Island a $3 million--$3.9 million grant to expand registered
apprenticeship opportunities. I think that this is one of the
areas that we have such a great opportunity. Electric Boat is a
great example. I was in Connecticut; we went through Rhode
Island to get to Connecticut. I know there is facility in Rhode
Island, as well, and the expansion that was going on there, and
the opportunity for employees.
I guess the best way I can sum it up is what I am going to
do about it is make sure that these investments are there, and
that we work with companies like Electric Boat, but the human
side of it. When I was at Electric Boat, I was talking to a
couple of apprentices that were standing there next to me, and
I got to talking with them.
And I am like: What are you doing? You know, did you go to
college? One kid went to college a little while, dropped out.
It wasn't for him. I told them my story. I dropped out of
college after a-year-and-a-half.
He is now on a pathway to a career. He is on a pathway to
working on submarines for the United States of America. He is
on a pathway to doing some amazing work. He is proud of his
work. He is happy with what he does. He told me he is earning
good money. He is making a living. He is able to raise a
family.
That is the type of stories that we need to continue to
happen. So I think it is incumbent upon us. If I do anything as
Secretary of Labor, it is making sure that the money in the
workforce development grants, in the apprenticeship program,
money that we get, we get out in the street because that, that
is going to be the fundamental, biggest game changer in the
United States of America, to get workers retrained, or workers
trained, and the ability to raise and get into the middle-
class. That is what we can do. That is the one thing. If I
accomplish anything and I do that, I will be happy.
COMBATING LITERACY ISSUES
Senator Reed. Well, thank you very much, Mr. Secretary.
Just a final point, not a question; as I was sitting down with
adult educators in Rhode Island a few weeks ago, they pointed
out that one of the problems is literacy; that they have a
significant number of adults who walk in and they want jobs,
they want to work, but they have very poor literacy, and very
poor numeracy and, digital skills too.
And I will just, not a question, but I assume, and I know
you will follow up with the Department of Education to try to
collaborate, to see how we can integrate our literacy programs,
as well as our training programs. And I will then--I won't
follow up with additional question. I will just, thank you.
Thank you, ma'am.
Senator Murray. Thank you.
Senator Kennedy.
Senator Kennedy. Thank you, Madam Chair.
BUDGET INCREASES
Mr. Secretary, welcome. I agree with you, by the way, for
what it is worth, about getting the money out on the streets,
literally. So I am looking at your budget here. Your current
budget is $12.5 billion. You are asking for $14.2 billion. Does
that sound about right?
Secretary Walsh. Yes.
Senator Kennedy. That is a 14 percent increase. You want an
extra $1.7 billion?
Secretary Walsh. Yes.
Senator Kennedy. Okay. Explain to me why the American
people would be better off giving you $1.7 billion, than taking
that $1.7 billion and spending it on infrastructure? I did a
little math and for $1.7 billion, we can resurface a four-lane
highway from Washington to Denver. So why are the American
people better off giving you more money than putting it on
infrastructure?
Secretary Walsh. Well, thank you very much, Senator. And
thank you for the question. It is a great question. And I think
the way I would think about it is the $1.7 billion increase to
my--to the budget, my budget is an investment in infrastructure
as well. It is an----
Senator Kennedy. It is what? I am sorry?
Secretary Walsh. Infrastructure investment as well. It is
an infrastructure investment in the American worker in this
country. It is an opportunity for us to look at, as I think
about the Department of Labor----
Senator Kennedy. Would you believe every--excuse me for
interrupting--I am sorry, Mr. Secretary.
Secretary Walsh. No problem.
Senator Kennedy. We don't have much time. Do you believe
that every expenditure by the Federal Government is an
investment?
Secretary Walsh. This----
Senator Kennedy. What is the difference between an
investment and an expenditure?
Secretary Walsh. An investment is an investment in the
future of workers, and expenditure is an expenditure in
building a bridge.
Senator Kennedy. Okay. Well, you have a union background,
which I respect and admire. If we took $1.7 billion that you
say you need, you need more to run your Department, and we
spent that on infrastructure. That is going to create a lot of
union jobs. Isn't it?
Secretary Walsh. It is going to create a lot of jobs, but
we are also not going to be able to educate the workforce that
needs those new jobs that are going to be created off of that
infrastructure investment of new bridges.
Senator Kennedy. But they are already educated. The people
building the roads are already educated. They are good at what
they do.
Secretary Walsh. Well, Senator Reed just mentioned of--an
issue around literacy in this country. So again, it is an
investment in helping people to be able to be retrained and
trained in the jobs of the future. I come out of construction.
I worked construction as well. The construction industry that I
worked on in the early-'90s and late-'90s is different than the
construction industry of today.
TAX INCREASES FOR INFRASTRUCTURE BILL
Senator Kennedy. Yes, sir. Let me stop you for a second. I
don't want to get too far afield here into a history of the
construction industry. I used to work construction too.
Let me be sure I understand what you are saying. When my
constituents call me and they say, look, you are being asked to
raise taxes to pay for infrastructure. Why, instead of putting
$1.7 billion in extra taxes on us, why did you give $1.7
billion to the Department of Labor? Why didn't you use that for
infrastructure? Am I just supposed to say, because the
Department of Labor says they are going to make an investment?
What metrics are you going to use this time next year to be
able to prove to this Congress that your investment paid off
better than $1.7 billion in infrastructure?
Secretary Walsh. Before I answer that, let me just quickly
go back to the tax question. I think the beauty for your
constituents is that the infrastructure bill that is being
negotiated right now does not raise taxes on the average
American who earns under $400,000. So the average American is
not paying for that.
Senator Kennedy. That is not true.
Secretary Walsh. Okay. Well, that is not why I am here
today.
Senator Kennedy. We just have to agree to disagree.
Secretary Walsh. It really----
DEPARTMENT OF LABOR SURVEYS
Senator Kennedy. Let me move on, because I have got one
minute left, and I like to stay within my time. Does your
agency conduct surveys?
Secretary Walsh. As far as employee surveys?
Senator Kennedy. Any surveys.
Secretary Walsh. We do, yes.
Senator Kennedy. Okay. Do you pay people?
Secretary Walsh. Pay the people who do the surveys?
Senator Kennedy. No, to take the survey.
Secretary Walsh. I actually don't know the answer to that.
Senator Kennedy. Well, here is why I am asking. And I am
not trying to----
Secretary Walsh. I will get back. I don't know. I don't
know the answer to that.
Senator Kennedy. I need your help finding something. One of
my constituents got this in the mail. It is a letter--I know it
is not under your jurisdiction--from the Bureau--Census Bureau.
And they asked him to fill out a form on children's health, and
he opened it up, and look what fell out, a five-dollar bill.
And there is no reference in the letter to the $5 in cash he
got from the Federal Government. What is this all about?
Secretary Walsh. I have no idea. I will look into----
Senator Kennedy. Can you help me find out?
Secretary Walsh. I will help you find out.
Senator Kennedy. I took the----
Secretary Walsh. I didn't get one of those letters.
Senator Kennedy. Well, I filled out my census, my survey. I
want five bucks.
Secretary Walsh. I do, too.
Senator Kennedy. And I understand that under the Biden
administration is also sending people $40 gift cards.
Secretary Walsh. I doubt that is from the Biden
administration. But I will look into it.
Senator Kennedy. I looked it up, it is on the Internet. It
must be true.
Secretary Walsh. I will look into it with you, my friend.
Senator Kennedy. Would you?
Secretary Walsh. I promise.
Senator Kennedy. Thank you, Mr. Secretary.
Secretary Walsh. All right, sir.
Senator Murray. Senator Shaheen.
IMPORTANCE OF THE JOB CORPS PROGRAM
Senator Shaheen. Well, thank you, Madam Chair.
And congratulations, Mr. Secretary, we are delighted to
have you in your current role, and it is nice to have a New
Englander who I can understand.
You were talking earlier about the need to have more
nontraditional apprenticeships, and the potential for doing
that for organizations to make that possible. One of those
organizations in New Hampshire is the Job Corps where they have
a number of training programs that train people for healthcare
roles, for dental assistants, for some of the things that have
been nontraditional.
Can you speak to the importance of the Job Corps and why it
is a great opportunity for young people who may not have
another alternative?
Secretary Walsh. Absolutely, Senator. Thank you for that.
You know, prior to my being here, I did not have, per se, a Job
Corps Center in the City of Boston, but we had lots of
workforce development programs. My first Job Corps visit was in
Memphis, Tennessee, where I got a chance to tour the Job Corps
facility there. And I saw first-hand the unbelievable potential
of creating pathways for so many young people in America.
And then I started to look into it, and realize the amount
of young people that go through Job Corps. Job Corps, there is
no question in my mind, that everybody today who brought up the
question with me so far, Job Corps should be a main stay in
Opportunity For Economic Development and Job Growth.
I think that we need to continue--I am going to continue to
partner with Job Corps. I am going to do everything I can. I
have asked for a budget increase for Job Corps. I am also going
to do everything I can to make sure that Job Corps all across
this country is successful.
I know your Job Corps in New Hampshire. I know it is
successful, and we want to take those models and make it
successful. So I am spending, you know--again not to kind of
get off the beaten path here--but I know when I became
Secretary of Labor, you know, people talk about OSHA,
unemployment insurance, and all of the--kind of the bigger
ticket items, Job Corps is as important as any of these, if we
do it right and continue to create pathways.
Senator Shaheen. Well, thank you. I worked for 20 years,
first as governor, to get that Job Corps, with a lot of other
people who supported it. So it is really nice to see it be
successful. And I appreciate the support from--your support for
Job Corps.
H-2B VISAS
Something that has not been so positive this year has been
the challenges with finding workers in New Hampshire, as
everyone has spoken to already. And one of those issues in New
Hampshire has been the access for H-2B visa workers. You and I
talked about this last spring. But we have a lot of seasonal
businesses that rely on H-2B visa workers to fill those
temporary jobs. When we don't have workers in New Hampshire who
are willing to take those jobs, and we have an unemployment
rate that is now back to under 3 percent.
Congress charged the Secretary of Homeland Security and
you, as Secretary of Labor, with the responsibility of
collaborating to determine the appropriate number of additional
H-2B visas to release for this fiscal year. I was disappointed
to see the administration's ultimate decision to release just
22,000 additional visas. And just 16,000 of those were set
aside for returning workers. They were fully applied for less
than 2 weeks after being made available.
So can you tell us how the administration determined that
22,000 number, and why only 16,000 of those should be available
for returning workers?
Secretary Walsh. Yes. I can. First and foremost, it was, as
somebody who was literally on the job about 3 weeks at that
particular moment, I sat with Secretary Mayorkas, and we were
looking at different numbers. He had a very high number--a much
higher number than that. And we were looking at the consistency
of what the past practice has been, and what the average number
of additional visas have been; 22,000--well, let me, 16,000 of
the traditional ones is about the average of the last 3 years,
not including last year, what the average was.
The 6,000 that were added was for the Northern Triangle of
Central America and Southern America. So we have made--my
office and Homeland Security's office is coming up with a
better formula for how we operate and move forward next year.
And I think that, certainly, your office, I spoke to you
directly, and Senator Hassan called me, and many Senators from
around the country called me as well, from all over the
country, really concerned about this.
We got the number out late. And so what we want to do now
is prepare for next year as we move forward so this same thing
doesn't happen. I know that in New Hampshire, Maine, and other
places, the tourism industry is in desperate need of these
workers, and other parts of the country, the fishing industry
is desperately in need of these workers.
And then we are also looking at the H-1B program as well
for the farmers. So I don't have a great answer for you, how we
came up with that number, other than we sat down and had a
compromise, a conversation. But I can tell you this: you have
my commitment that next year we will not be dealing with this
at the last minute. We will have this conversation beforehand,
and may be even an opportunity for me to visit with you and
talk to some of the workers that are in your State, to talk
about the importance of that program.
Senator Shaheen. Well, thank you very much. I appreciate
that.
ADDRESSING THE WORKFORCE SHORTAGE
And I know I am out of time, Madam Chair. But I would just
remind us all that we are dealing with an aging workforce in
this country. And if we expect to fill the jobs that we are
creating, we need to get more older workers into the workplace,
and we need to get more immigrants into the workplace. And I
understand that is a charged political issue, but it is one we
need to face if we are going to address our workforce shortage.
Thank you.
Senator Murray. Thank you.
Senator Baldwin.
Senator Baldwin. Thank you, Chair Murray.
PARTNERS ACT APPRENTICESHIP LEGISLATION
Secretary Walsh, I am going to join the chorus here as a
big supporter of apprenticeship programs. And I plan to shortly
re-introduce my apprenticeships legislation, known as the
PARTNERS Act, in the near future. That is focused particularly
on collaboration between smaller work places, and technical
colleges, and workforce Boards to sometimes create novel
apprenticeships, but to assist, especially, smaller businesses,
in standing up apprenticeship programs.
DIVERSITY IN APPRENTICESHIP PROGRAMS
Anyways, I was pleased to see that your budget requested a
$100 million increase for apprenticeship programs, along with a
commitment to increase access to apprenticeships for,
historically underrepresented groups. I wanted to call your
attention to my home State of Wisconsin, where in Milwaukee we
learned that the number of Black apprentices decreased by
nearly 22 percent over the last year. That is a deeply
disturbing statistic.
And so I am interested in learning how the Department will
use the appropriated funds to attract more racially-diverse
apprentices. And what strategies you have to prevent the sort
of numbers that we have seen in Wisconsin, and Milwaukee in
particular?
Secretary Walsh. No. Thank you. I was in Milwaukee about 3
weeks ago, or with the Mayor, and we were on a job site,
replacing lead pipes, they were replacing lead pipes in one of
the neighborhoods in Milwaukee. And prior to that I was at a
roundtable with the Building Trades, I think that there are two
things we have to do.
Number one is, I think the people that we have to--that
want to get access to these apprenticeship programs, that there
are people of color, African-American, Latino. People want to
get in. It is about, you have to be real intentional about
reaching out to the community and creating open-door
opportunities for these programs. I have done it in the city as
a head of the Building Trades. I have done it as the Mayor of
the City of Boston.
And I think that we have a unique opportunity right now in
the--you know, at the Department of Labor equity is kind of at
the core of everything that we are doing, and we need to make
sure, if we want to really come back and build back better, it
has to be built back better for all people, it cannot just be
build back better for some communities.
And so I think we--number one, to answer your question, at
the Department of Labor, when we start to think about putting
RFPs (Request for Proposals) out, we start to expand these
apprentice programs, we also have to put in some
recommendations on how, and explain to people, how do you get
people that don't have access to these programs, access.
So you just got to be intentional about it, bottom line. I
mean, in Boston, it has worked. I mean, are the numbers great?
No. Are the numbers better? Yes. So we have to be better than
we were.
IT SOLUTIONS FOR AGING UI SYSTEMS
Senator Baldwin. During the pandemic Wisconsin's Department
of Workforce Development really struggled to make timely
unemployment insurance payments because of outdated computer
systems.
Secretary Walsh. Yes.
Senator Baldwin. And they were a product of years of
neglect, and frankly, partisan attacks on the unemployment
insurance program to begin with. I am encouraged to see that
your budget will provide, again, $100 million specifically for
IT solutions that can be deployed in the State. And this money,
I think will be well spent in Wisconsin. But I was also
interested in learning more about the first comprehensive
update in decades to the formula that determines the funding
States received to administer unemployment.
Can you provide more information on the proposed changes to
the formula? And is this something that the Department expects
to undertake administratively? Or do you think you are going to
need changes to authorizing language?
Secretary Walsh. Well, first of all, thank you for bringing
this up. Because as I was prepping for this hearing, most of my
prep was about--around unemployment insurance, so I thank you
for bringing it up. I think that a lot of what we can do,
Department of Labor, is working, going to be working with
States and territories to be able to look at what investments
are needed in those different areas.
We are using the funds that--through the American Rescue
Plan to tackle the most acute problems that the systems have
been facing for a long time. There are kind of four key
priorities, which I will touch upon: one is sending teams to
States to provide intensive technical assistance that is first
and foremost, really finding out, because every State system is
a little different on how they operate, and their computer
systems are completely different. We are going to provide
States with direct assistance and experts, to learn about the
challenges, and to begin to help immediately on what we need to
do. So that is one space.
Second is a focus on ID verification, and looking in that
area. A third is modernizing technology, probably one of the
biggest things that we have an issue with is technology, and
States are running on incredibly antiquated systems that they
have had for 30, 40, 50 years; and then a direct grant to
States to help them solve the challenges that they have in the
system.
I mean, reforming the united system will do a lot. Number
one, as you mentioned at the very beginning, at the beginning
of the pandemic people had problems accessing the benefit. They
couldn't get in. They were waiting, and they were waiting on
Zoom, they were waiting in the line, they were waiting and they
couldn't get through.
So creating a platform, a system, when somebody needs
unemployment, they can either sign up online, or get a phone
call. They can get in; number one.
Number two; it is also the fraud piece of it. Lots of--
there was lots of organized crime and fraud with the UI system
where millions and billions of dollars were taken that should
have gone to people. Again, that will address the fraud.
So we are going to have a comprehensive approach moving
forward. We are being very, very, focused on how we administer
this program, and how we move forward.
Senator Baldwin. Okay. And if you can follow up with some
more information about the formula changes that are being
undertaken, that would be great.
Secretary Walsh. Yes. I will get back to you. Thank you.
Senator Murray. Thank you very much.
BUDGET INCREASES FOR WORKFORCE DEVELOPMENT PROGRAMS
Mr. Secretary, the budget request includes significant
increases in funding across the workforce development program,
and like COVID itself, the economic impacts of the pandemic
issue now have fallen disproportionally on the most vulnerable,
including women, workers with low incomes, workers of color; so
the investments in this budget would help our economic
recovery, but also address changing workforce needs that were
apparent actually long before COVID; such as the transition to
clean energy, and the development of other in-demand industries
and sectors.
Can you talk to us about why the increases in workforce
development programs are so important right now, and
specifically what this budget does to address inequities in our
workforce programs?
Secretary Walsh. Yes. Let me try and do a better job than
the first time I was asked the question. Most people here today
that have asked me a question have discussed either, the
underemployment of people, or the lack of ability to get into a
better paying job. What the pandemic--we have known this before
the pandemic--but what the pandemic has really shown is that we
are in a crossroad in our country, and we have an opportunity
to create a platform for people to get into the middle-class.
President Biden's ``Build Back Better'' plan, not the plan,
but build back better, the words ``build back better'' when he
talked about in the very beginning before there were any plans
associated with that, was about creating opportunities and
pathways into the middle-class, that people wouldn't have to
live in poverty, people wouldn't have to worry about
unemployment, people wouldn't have to worry about not having
healthcare, and child's care, daycare, education, all of that.
And what our workforce investments are--what we are asking
for in this budget, and what we want to do with our workforce
investments in the Department of Labor, in this budget, is to
continue to advance what the President's agenda is, what we all
want to do moving forward. And so for every dollar that we
spend, with all due respect to one of the Senators today, for
every dollar that we spent in workforce development, it is an
investment in the future of America's workforce. And it is an
opportunity.
Ranking Member Blunt mentioned new emerging tech--new
emerging industries, those industries right now, a lot of them,
are just for college graduates. They are going into cities like
Boston, and they are grabbing up college graduates, but they
have more opportunities than they have people to work in those
jobs. And when I--when you talk to those CEOs, and the people
that create those companies, what they say is that we can train
the workforces to work in those industries. We don't need to
have a college degree, or a Ph.D, or a law degree.
So we have a unique opportunity right now. So the
investments that I am asking this committee to support, and I
am going to be asking the Full Senate and Congress to support,
are investments we are making in the future of American
workers.
We don't want the same-old, same-old Department of Labor,
where we are going to be giving grants to States and States
will be taking the money and maybe doing something with it.
What we want to do is make sure that these investments are
going in the right places so we can continue the opportunity to
get our--your constituencies, my constituents into good-paying
jobs.
That is the opportunity in front of us at this particular
moment in time. And I think that nobody wants to go back to the
old way. I think it is important for us, we continue to make
investments in American people for those jobs.
COMBATING WAGE THEFT
Senator Murray. Okay. There are workers around the country
right now, as you well know, trying to support their families,
make ends meet, but they are being denied the unacceptable--or
the unacceptably low Federal minimum wage, overtime pay, or
both. And it is clear more needs to be done to ensure workers
received the wages that they actually earn. And it is the Wage
and Hour Division's job, as you know, to investigate these
cases and recover back wages and damages on their behalf. Can
you talk to us about how your Department would use the $30
million increase that you have requested for Wage and Hour, to
address wage theft or increased back pay recovery, particularly
for our vulnerable workers?
Secretary Walsh. Yes. First and foremost I want to--again,
I wanted to just thank you for the American Rescue Plan because
we have made some investments there as well in Wage and Hour,
and we are building back up where we were a previous--to
previous levels. The investments that we want to invest there,
again it goes back to thinking about the Department of Labor in
a different way, as far as, the way I view the Department of
Labor is we represent workers in the morning, in the afternoon,
and at night.
And we represent workers in all different levels, whether
it is security on the job site, safe retirement, and safe
working conditions. So what we want to do in Wage and Hour is
make sure that we truly make an opportunity for people that are
being shortchanged or not getting their wages that they earn
and deserve, that we have the proper opportunity for
investigation to go in and investigate any cases out there, so
we are able to follow up, and get people's back wages.
If you look at the Department of Labor's website, every day
we have another case where we are able to recoup benefits of
people that lost their money.
Senator Murray. Thank you.
Senator Blunt.
Senator Blunt. Thank you. Thank you, Chair.
ALLEVIATING LICENSING RESTRICTIONS FOR MILITARY WORKERS AND THEIR
SPOUSES
The President on Friday released an executive order that
encourages the FTC (Federal Trade Commission) to ban
unnecessary occupational licensing restrictions. I have been
particularly involved in that as it related to returning
veterans who bring skills back with them, or veteran spouses or
military spouses who are going from one State to the next. What
are you doing? And what do you think we can do to encourage
more cross-State collaboration in licensing, and to eliminate
needless barriers for licensing, particularly for those people
who in some way have either been in the military, or have
spouses in the military?
Secretary Walsh. Yes. I don't have a direct answer for you
to that question, but my past understanding of being in the
legislature, or in the City of Boston as the mayor, it is a
concern because people would come to our city and they would
want to work in a certain industry, and the license was not
recognized in the City of Boston.
And there was an ability at the State level to get a
waiver, but it is something that I don't have enough
information on, and I will look into it. But I definitely think
that, particularly military families, as military families they
are not in--I have a cousin that is in the Coast Guard. In the
last 10 years he has spent time in San Diego, up in Portland,
Maine, he has been all over the country because he gets shifted
from base to base every 3 years.
Senator Blunt. Right.
Secretary Walsh. So again, you know, if he had a career
that, a side career that had a license, he needed to get that.
So let me--I will work on that with you. I don't have the
direct answer for you on that.
Senator Blunt. Let us work on that. I think the executive
order clearly heads in the right direction, but let us work on
what we can do now. That is largely a State and a local
determination. Up until this point many of the States,
including Missouri, are moving in the direction of making it
much easier. We just, I think our first military spouse that
got an immediate license when she came to this State, was a
lawyer, who, within a few days of moving to Missouri with her
husband who was at Fort Leonard Wood was practicing law. And
the more of that sort of thing, whether it is a lawyer, or a
beautician, or an electrician, or----
Secretary Walsh. A teacher.
INCREASE IN H-2B VISAS
Senator Blunt [continuing]. A commercial truck driver,
whatever those licenses are, I want to work with you on that.
In another area, I was pleased to see the Department, in
conjunction with the Department of Homeland Security, announce
the availability of an additional 22,000 H-2B visas, provided
for in the 2021 Omnibus Bill. You know, these H-2B visas are, a
lot of them in hospitality, and landscaping, in timber.
In our State, I see those generally as jobs that actually
protect the other jobs that are there, coming in, filling a
part-time gap that allows the full-time Missouri resident
employees to have a job that they wouldn't have, if the hotel
couldn't be open, or that they wouldn't have if all of the
landscaping work that needs to be done at a given time,
couldn't be done.
I don't want a detailed answer from you here today, but I
would like you to commit to working with this subcommittee to
guarantee that the program has sufficient returning workers to
meet the seasonal needs of our small businesses, and our local
industries. And fishing would be one of those industries in
coastal areas. Senator Mikulski and I used to work closely on
this particular issue.
Would you be willing to continue to work with us on this,
Secretary?
Secretary Walsh. Yes. There is no question about that. And
not only that, I think that this program also benefits the
people that are coming here, working and taking back home, the
revenue back home to their families. And I think that that also
is a kind of a win-win for all sides. So I certainly will
continue to work with you on that.
FUNDING FOR THE APPALACHIAN AND DELTA COMMISSIONS
Senator Blunt. Another area I mentioned in my opening
comments was that your budget request included a $35 million
set aside to serve workers in the Appalachian and Lower
Mississippi Delta regions, that we began funding in 2018. I was
the Chairman of the committee at the time, and Senator Murray
was the ranking member, and that funding has created, and will
create employment opportunities by providing reemployment and
training assistance in areas where they are needed.
Can you speak to the success of the grants in this area,
these regional commissions, like the Appalachian Regional
Commission, and the Delta Regional Commission?
Secretary Walsh. Certainly. I mean, there is no question
that these grants are beneficial to those areas of the country
and, you know, I hear, the feedback I get from the Department
of Labor, from the workforce development side of it, is that a
lot of these different areas want increased grants, and
opportunity to access to grants. So it is beneficial. And that
is why the additional revenue that I am looking for in some of
this workforce development and grant money will allow us the
opportunity to make more investments in those areas.
Senator Blunt. Thank you, Secretary.
Chair, I think that I will have some more questions for the
record. But I believe those are, at this point, at least all
the questions I have for the hearing today.
Senator Murray. Very good.
Senator Braun.
OSHA ENFORCEMENT BUDGET INCREASE
Senator Braun. Thank you, Madam Chair.
And good to see you, Mr. Secretary, enjoyed our
conversations in the past. And, you know, I come from the
business world, and especially small business, and I have been
able to see our business grow over the years, and interface
with all the things you have to do with government. And I have
always felt an inherent responsibility to do things right, keep
your employees safe, that that is part and parcel of growing an
enterprise.
I noticed where there is a request for $350 million
increase in enforcement funding, and would be curious, I tried
to get the information what that is on top of already, and is
it related to. I know maybe during the Trump administration,
which I welcomed, a lot of easing up on certain stuff that
maybe was in overdrive, still acknowledging that many things
need to be in place to keep a safe environment, to keep a safe
workplace.
Has there been an uptick in OSHA-related cases that would
warrant that kind of increase that would be targeted towards
enforcement?
Secretary Walsh. That is a great question. The problem we
have with OSHA is that we have seen an increase in cases, and
we have also seen a decrease in OSHA inspectors. So I guess the
answer is: that we are seeing increased potential problems, and
we have fewer people to go out and investigate those problems.
So we have a lot of our cases that are going kind of, I guess,
unchecked, if you will.
Again, as I said earlier, before you came in Senator, this,
I would like to get OSHA to a point where it is not just going
out and seen as a ``gotcha'' organization. I mentioned, when I
was a younger person, I worked on construction, and OSHA would
come out to the job site, and not because they are out there
because of an accident, they are out there to make sure that
there was proper safety procedures in place in construction,
which is dangerous, as you know.
I would like to get OSHA back where we are doing a lot more
collaboration of working with businesses to make sure we create
work--safe work sites across America, rather than having to
respond to a tragedy. And we are not there yet. So the increase
that we are looking for is to build back the OSHA Department,
and build back the Department of Labor to pre--you know, the
last 5 years we are down, the lowest amount of inspectors, I
believe, in the history since the beginning of the Department
of Labor, we are at the lowest number right now.
Senator Braun. So what I would like, and you can get that
to our office, would be: what the number of enforcement issues
have been from 5 years ago to the present, what the funding
levels were each year, to make sure it might get related to
that in some fashion.
OSHA ENFORCEMENT IN LARGE BUSINESS VS. SMALL BUSINESS
And then also I would want to bring up the distinction
between large business and small business. And NFIB (National
Federation of Independent Business Inc.) has been out there
with so many stats that have shown that small businesses have
been decimated, challenged with COVID, some of the things they
had to do there that was on top of what they have to normally
do to move forward and prosper. And I have also been an
observer there. The smaller your business is, normally, the
more intimate that relationship is with your employees.
So again, I would like to know whether the Department
currently differentiates between how it looks at enforcement
among big businesses versus small businesses. And to see if
there is a distinction in how you carry out those functions.
Secretary Walsh. Yes. Let me get back to you on that one. I
don't have the answer for you.
Senator Braun. Yes.
Secretary Walsh. But I understand here what you are saying.
And when you talk about small businesses, you are not
necessarily talking about the three-person mom-and-pop store,
you are talking about the 200-person store and----
Senator Braun. I would give it 500 and fewer.
Secretary Walsh. Yes.
Senator Braun. And it is that----
Secretary Walsh. So let me get back to you on that.
Senator Braun. Yes.
Secretary Walsh. Because I understand, I recognize the fact
that there is a big difference between a small business and a
corporation.
Senator Braun. Especially 50 and under.
Secretary Walsh. Yes.
Senator Braun. But let us take the common definition, and
whatever is being done in the future, I would want to make sure
it is based upon the need to do it, number one, especially in
the context of scarce resources. So much of what we are doing
today and not just after the Biden administration took over,
because we do it on borrowed money on anything that we do
enhance in a budget. And I think that will come into question
in the long run as well.
So if you could get back to my office on those two
particular pieces of information, I would appreciate it.
Secretary Walsh. I definitely will.
And I was at the Indy 500 the other day, I went around the
track, it was pretty amazing.
Senator Braun. Yes. And that is a kind of, I guess, a big
version of a small business.
Secretary Walsh. Yes. It certainly is.
Senator Braun. Right in my home State.
Secretary Walsh. It certainly is. It was interesting. It
was fun.
Senator Braun. Yes. Okay. Thank you.
Secretary Walsh. Thank you, Senator.
Senator Murray. Thank you very much.
That will end our hearing today, Mr. Secretary; and our
hearings on President Biden's Budget Proposal for fiscal year
2022.
I want to thank all of our fellow committee members for
their participation.
Secretary Walsh, thank you for your very thoughtful
answers. I look forward to continuing to work together with you
to fight for workers, and build a stronger, fair economy for
everyone.
ADDITIONAL COMMITTEE QUESTIONS
For any Senators who wish to ask additional questions,
questions for the record will be due Friday, July 23 at 5 p.m.
The hearing record will also remain open until then for members
who wish to submit additional materials for the record.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted to Hon. Martin J. Walsh
Questions Submitted by Senator Patty Murray
whistleblower complaints and staffing
Question. I'd like to follow-up on my question about OSHA's
whistleblower program. Last year's Inspector General report described
the significant increase in complaints and insufficient staff to
investigate those complaints during the pandemic.
Please describe the impact of complaints not being timely and
effectively investigated and the steps planned and being taken to
address this issue.
Answer. Over the past several years, OSHA has experienced a
significant increase in new whistleblower complaints being filed, while
the level of staffing has remained steady. This, coupled with new
whistleblower statutes added to the agency's growing portfolio,
including statutes unrelated to worker safety and health, has resulted
in a significant increase in the inventory of outstanding
investigations, with many going on for extended periods of time
(overage/backlog cases). These factors have created a lag time in
completing investigations and making agency determinations based on the
merits of the complainants' allegations. With the onset of the
coronavirus pandemic (with more than 5,500 COVID-19-related
whistleblower complaints filed so far), the additional increase in new
filings and subsequent backlog inventory have limited the agency's
ability to complete investigations in a timely manner. If OSHA does not
have sufficient resources to meet quality and efficiency standards for
its whistleblower investigations, and is unable to review all
complaints alleging workplace retaliation, the agency cannot properly
protect employees' rights to engage in protected activity and prevent
retaliation.
OSHA has taken many steps to address the challenge of achieving a
reasonable balance between an investigation's timeliness and quality in
order to handle its whistleblower inventory more efficiently and
effectively. First, the agency instituted a pilot program whereby the
agency conducted two rounds of assignments of complaints across
regional boundaries, allowing for regions with a lesser workload to
assist regions with a higher workload, focusing on establishing a more
reasonable workload balance nationwide. OSHA is actively exploring
other avenues to address backlogged inventory, both nationally and
regionally. Second, the agency is overhauling the Whistleblower
Investigations Manual (WIM) to streamline procedures without
compromising case quality. OSHA instituted a new Pilots Directive that
allows for innovative ideas and suggestions to be `tested' to see if
added efficiency is gained and successful pilots are incorporated into
the WIM and made national policy. Third, OSHA developed an
investigative checklist to ensure that key investigative steps are
followed, establishing clear and effective case monitoring during the
final stages of an investigation, and thus ensuring that the quality of
the investigation is maintained. Finally, OSHA is actively hiring
additional whistleblower staff to assist not only in addressing the
inventory of backlogged cases but also the total inventory of cases, by
promptly processing and investigating new complaints so they don't
become overaged. The agency's fiscal year 2022 budget request also
includes a requested increase 63 FTE and $5.3 million to provide
additional whistleblower staff to meet the workload demands.
OSHA will also continue to engage its stakeholders with meetings
throughout the year. These meetings provide a forum for the public to
offer suggestions and comments on ways the agency can improve the
whistleblower program. This will allow OSHA an opportunity to go beyond
the protection of individual whistleblowers by increasing outreach
efforts through the Whistleblower Outreach Plan in an effort to educate
employers about their responsibilities and employees on their rights
afforded under the statutes OSHA enforces. The agency will focus its
outreach efforts on industries with the highest, as well as the fewest
number of complaints filed, whistleblower protection provisions of the
newest statutes enacted, and vulnerable populations least aware of
worker protections while also continuing to promote the ``Recommended
Practices for Anti-Retaliation Programs'' guidance for employers. This
document outlines the steps recommended for employers to establish a
workplace where employees feel comfortable raising concerns, without
fear of retaliation. In turn, the employer benefits from improved
employee morale and productivity, as well as the likelihood of fewer
whistleblower complaints being filed by its workers.
Question. How would the American Rescue Plan Act funds, additional
funds requested in the fiscal year 2022 budget and policy changes
address a recommendations made by the Office of Inspector General to
more equitably distribute whistleblower complaints amongst
investigators, and provide consistent enforcement of whistleblower
rights among the regions.
Answer. OSHA will use the funding received under the American
Rescue Plan Act to address COVID-19 related whistleblower complaints.
OSHA published the COVID-19 National Emphasis Program, which
prioritizes investigating employers that retaliate against workers for
complaints about unsafe or unhealthy conditions, or for exercising
other rights protected by Federal law. OSHA plans to spend $13,079,000
to support 32 FTE in the Whistleblower budget activity, including 25
investigators over the course of the three-year supplemental. Funding
would also support seven national and regional whistleblower staff to
address evolving policy issues, and provide required high level review
of the growing number COVID-19 retaliation claims received by the
agency, with more than 5,500 COVID-19-related whistleblower complaints
filed so far.
In fiscal year 2022, OSHA is requesting $24,999,000 and 185 FTE,
which includes a program increase $4,100,000 and 50 FTE for
whistleblower investigators to effectively enforce 25 whistleblower
statutes, including the recently added Criminal Antitrust Anti-
Retaliation Act and the Anti-Money Laundering Act. In addition to
investigators, OSHA is requesting a program increase of $1,243,000 and
13 FTE to support the Alternative Dispute Resolution (ADR) Program,
policy development and review, and appropriate management support for
the Whistleblower Protection Program (WPP). As part of the effort to
build a stronger whistleblower program and have the necessary level of
resources to support the significant number of whistleblower statutes
the agency has been mandated to enforce, OSHA will make sure that every
worker, especially those in vulnerable and underserved communities,
knows about their rights and what to do if they believe their safety
and health is not being protected. The agency is committed to ensuring
that every worker is protected and feels empowered to raise concerns
when they feel their workplaces are unsafe.
The additional investigators requested in fiscal year 2022 will be
distributed throughout the agency's regional offices with a focus on
preventing an increase in the backlog of complaint investigations while
also reducing the overall inventory of pending investigations. The
requested resources will help OSHA keep up with the high demand, and
ensure that workers' concerns are properly and thoroughly processed and
responded to as expeditiously as possible.
OSHA has taken many steps to address this challenge of achieving a
reasonable balance between an investigation's timeliness and quality in
order to handle its whistleblower inventory more efficiently and
effectively. First, the agency instituted a pilot program whereby the
agency conducted two rounds of assignments of complaints across
regional boundaries, allowing for regions with a lesser workload to
assist regions with a higher workload, again, focusing on establishing
a more reasonable workload balance nationwide. OSHA is actively
exploring other avenues to address backlogged inventory, both
nationally and individually by Region. Second, the agency is
overhauling the Whistleblower Investigations Manual (WIM) to streamline
procedures without compromising case quality. OSHA has instituted a new
Pilots Directive that allows for innovative ideas and suggestions to be
`tested' to see if added efficiency is gained--those successful pilots
are incorporated into the WIM and made national policy. Third, OSHA
developed an investigative checklist to ensure that key investigative
steps are followed, establishing clear and effective case monitoring
during the final stages of an investigation, and thus ensuring that the
quality of the investigation is maintained. Lastly, the agency is
actively hiring additional staff to assist not only in addressing the
inventory of backlogged cases but also the total inventory of cases, by
promptly processing and investigating new complaints so they don't
become overaged.
In addition, with new fully trained staff in place, along with new
staff requested in the fiscal year 2022 Budget Request, OSHA will
continue to streamline its processes by developing alternative
procedures through piloted programs and strategies that are evaluated,
found to be effective, and implemented nationwide. Specific focus will
continue to be placed on backlog reduction strategies to reduce the
inventory of overaged cases. Additionally, OSHA will continue its
efforts to expand the use of the Alternative Dispute Resolution (ADR)
Program, which has proven to be an effective strategy to efficiently
process complaints/cases in a timely manner and with positive results.
With the delegation of two additional whistleblower laws in fiscal year
2021, the Anti-Money Laundering Act (AMLA) and the Criminal Antitrust
Anti-Retaliation Act (CAARA), OSHA plans to conduct training on the
investigative processes concerning these new laws for its staff in
fiscal year 2022, as done with the Taxpayer First Act (TFA) in fiscal
year 2020. OSHA also plans to develop an Intranet-based Whistleblower
Investigator (WBI) Resource Page for whistleblower personnel that will
include technical assistance and answer a myriad of questions presented
by the field, including those related to COVID-19, which is constantly
evolving. This will be accessible to all Regions, ensuring nationwide
consistency. All of the initiatives will be developed and implemented
to assist the agency in addressing the recommendations made by the
Office of the Inspector General.
davis bacon enforcement
Question. Mr. Secretary, construction workers across this nation
rely on the Department's Wage and Hour Division to enforce their right
to prevailing wages on federally assisted construction projects. As a
former construction worker, you know as well as anyone that
construction is hard, dangerous work. These protections ensure the
Federal Government is creating good jobs with fair pay and bringing
countless economic benefits to local communities. The workers and
communities who build our bridges, highways, and other critical
infrastructure deserve the protections and the benefits prevailing wage
provides.
Mr. Secretary--how would your Department use the funds requested
for the Wage and Hour Division to better enforce the Davis-Bacon Act,
particularly with respect to working with other Federal agencies to
ensure compliance?
Answer. The Davis Bacon Act protects construction workers' rights
to receive the local prevailing wage and leverages the purchasing power
of the Federal Government to support local contractors, local workers,
and local economies. The Department is currently engaged in a
comprehensive review of its Davis Bacon program including outreach,
education, compliance assistance in partnerships with contracting
agencies and enforcement. Additional enforcement resources will allow
the Wage and Hour Division to put more investigators into the field and
onto construction sites to make sure workers are getting the wages they
have earned on Davis Bacon projects.
ilab monitoring and enforcement
Question. Mr. Secretary, my home state of Washington is one of the
most trade dependent economies in the United States. That's one of the
reasons I support trade deals with strong labor and environmental
protections. So, I was pleased to see the budget proposes $124 million,
an increase of more than $27 million, for the International Labor
Affairs Bureau. This includes significant new investments for ILAB to
expand trade-related monitoring and enforcement of labor provisions in
our trade programs and new resources to investigate the use of forced
and child labor in global supply chains.
I know you have dedicated resources for work on our trade agreement
with Mexico and Canada. However, with 150 international trading
partners under existing free trade agreements or trade preferences,
your budget request won't stretch far enough to conduct monitoring and
enforcement with all of our trading partners.
How will you prioritize countries for monitoring and enforcement
activities?
Answer. DOL is committed to monitoring and enforcing the labor
provisions in all of our trade agreements and preference programs. Over
the last year, in addition to creating a new division dedicated to
enforcing the labor provisions of the U.S.-Mexico-Canada Free Trade
Agreement, our Office of Trade and Labor Affairs (OTLA) within the
Bureau of International Labor Affairs has increased the staffing level
and resources devoted to enforcing labor provisions in the other trade
agreements and trade programs as well. This has enabled us to intensify
our engagement with countries with the greatest need. For example, so
far in 2021, the Department has dramatically increased its work
allocated to our trade agreement with Central America (CAFTA-DR),
enabling us to integrate labor enforcement into the important work
being led by the White House on Central America. Likewise, with the
preference programs, we are continuing to monitor all countries
benefiting from the Generalized System of Preferences (GSP) and the
African Growth and Opportunity Act (AGOA) through the GSP triennial
assessment and the annual AGOA review. Based on these processes, our
team prioritizes and engages with key countries in an ongoing manner.
Both the GSP and AGOA processes consider information from a broad array
of sources, including U.S. government reporting, international and
national labor rights organizations, and public comment mechanisms
included in the preference programs. Our team shares the results of its
fact-finding, along with recommendations for priority countries, with
the Trade Policy Staff Committee (TPSC). Subsequent discussions with
interagency partners further shape OTLA's identification of priority
countries and inform ongoing strategies for engagement to promote
progress towards meeting the worker rights eligibility criteria.
Question. And, how will you partner with the State Department and
Office of the Trade Representative to ensure the most robust
enforcement possible of labor provisions in our trade programs?
Answer. DOL works closely with the Department of State and the
Office of the U.S. Trade Representative (USTR) in our goal for strong
enforcement of labor provisions in our trade agreements and trade
preference programs. DOL engages with key countries through bilateral
work and is in constant communication with our interagency partners,
trade partner country stakeholders, and the International Labor
Organization to maximize our effectiveness in labor enforcement. In
addition, DOL works with State and USTR in a variety of formal
mechanisms, such as the Trade Policy Staff Committee (TPSC), labor and
trade-related working groups such as the CAFTA-DR working groups, and
Trade and Investment Framework Agreements (TIFAs). For example, DOL's
Office of Trade and Labor Affairs (OTLA) collaborates with USTR's labor
office to develop and deliver talking points on labor priorities in
connection with TIFAs between the U.S. and parties to the TIFA. OTLA
also convenes regular calls with USTR and State to discuss and share
updates on priority labor issues, and ensures USTR and State's
participation on relevant labor-related country briefings.
child labor
Question. According to the latest report on child labor produced by
the International Labour Organization and UNICEF, the number of
children in child labor around the world dropped from 246 million in
2000 to 152 million in 2016. Unfortunately, this 16-year downward trend
has been reversed over the past 4 years, increasing to 160 million
children worldwide in 2020 with nearly half of these children engaged
in hazardous work.
Please describe how funds currently available to the International
Labor Affairs Bureau will be used to contribute to a reversal of this
increase in child labor.
Answer. Reversing the upward trend in child labor, as reported in
the latest ILO and UNICEF global estimates, will require a multi-
faceted approach. A range of factors have contributed to the
significant increase in child labor noted in some parts of the world,
particularly Sub-Saharan Africa. ILAB is increasing its focus on a
number of key areas where there is a great need and where we can have a
significant impact. This includes increased focus on global supply
chains; promoting greater access to social protection, training, and
education opportunities for vulnerable children and families;
confronting gender and racial inequity; and strengthening worker voice
and workers' rights.
ILAB's Office of Child Labor, Forced Labor and Human Trafficking is
currently overseeing 46 projects with activities in over 40 countries.
These projects are addressing root causes of child labor and forced
labor through research, awareness raising, education, improved
livelihoods, strengthening labor laws and enforcement, and by
increasing the capacity of governments and other stakeholders to scale
up and sustain effective practices for preventing and reducing these
abusive labor practices. ILAB has also worked with these existing
grantees to address urgent needs resulting from the global pandemic.
ILAB has allocated project resources to increase vulnerable groups'
access to information about the virus, address food insecurity, support
remote education and training, and provide masks and hygiene resources
to reduce exposure of vulnerable children and workers. ILAB is also
deeply engaged in addressing child labor and forced labor in Sub-
Saharan Africa, with over $40 million in active programming in the
region, including more than $18 million in new programming awarded in
2020 addressing child labor in key supply chains such as cobalt, cocoa,
and mica. These projects include a focus on issues of gender equity and
the need for enhanced monitoring and remediation. With fiscal year 2021
funds, ILAB is also currently in the process of funding new projects
that will address some of the key gaps identified in the ILO-UNICEF
report. For example:
--In Malaysia, ILAB is funding a $5 million project to combat forced
labor and child labor by increasing advocacy by workers and
civil society in the production of palm oil and garments,
worker voice in the implementation of a social compliance
systems, and workers access to remedies in these sectors.
--In El Salvador, Guatemala, and Honduras, a $7 million ILAB-funded
project will build civil society and workers organization
capacity to address child and forced labor and other
unacceptable conditions of work, promote greater gender and
racial equity, and address the needs of some of the most
vulnerable populations in these countries, including persons of
African descent and indigenous communities.
Moreover, as part of our efforts to achieve a larger and more
sustainable reduction in child labor and forced labor, ILAB will
actively engage with governments, the private sector, worker
organizations, civil society actors, other donor governments, and
international organizations to promote the replication of effective
practices. ILAB will call on governments to mainstream child and forced
labor elimination strategies into broader social initiatives as a way
to take to scale strategies that can help to reduce the vulnerability
of children, families, and workers to abusive labor practices. ILAB
will also continue to use its flagship reports on child labor and
forced labor to urge governments to take specific action to reduce
these abusive labor practices.
Question. How would resources requested in the fiscal year 2022
budget build on and learn from prior investments?
Answer. From more than 25 years of experience funding international
child labor projects and contributing to significant strides in the
fight against child labor, we have learned that our most successful and
impactful initiatives are those that adopt a holistic approach, based
on a broader rights-based ecosystem that places workers and vulnerable
communities at the center. We have also learned that it is critical to
create the right incentives for governments and businesses to take
actions to address child labor and forced labor, particularly in global
supply chains.
In fiscal year 2022, ILAB will focus its programming on addressing
the persistence of abusive labor practices in supply chains, including
through the funding of research to trace goods through supply chains
and targeted action to increase workers' voice in the monitoring of
labor rights abuses. Rigorous research and reporting can help us hold
both governments and corporations accountable for goods produced by
forced labor and child labor throughout the supply chain. We will also
support projects that help address decent work gaps, as child labor
tends to persist where adult workers cannot exercise their rights at
the workplace, especially the rights of freedom of association and
collective bargaining. Another critical element of ILAB's approach will
be to promote good practices and the expansion of social protection
schemes that build social safety nets for vulnerable communities where
labor abuses are most prevalent (e.g., in rural areas, in agricultural
sectors). ILAB will also increase support for workers in informal
sectors, where vulnerability to labor exploitation is more pronounced,
as noted in the new ILO-UNICEF global child labor estimates, including
through support for informal worker organizations. ILAB's increased
focus in these areas will be particularly important in addressing the
significant increase in child labor in Sub-Saharan Africa, as well as
the persistence of child labor in other parts of the world. Finally,
ILAB will partner with other donors and organizations to leverage our
resources and experience and support our goal for the replication and
scaling up of good practices to achieve the broader impact needed.
ILAB will continue to use evidence to inform action, drawing upon
our own research and reporting on forced and child labor as well as
lessons learned from past and current projects. ILAB's research serves
as an essential knowledge base for ILAB's technical cooperation
projects, helping ILAB focus its technical assistance in areas where it
is most needed and where it can have the greatest impact. ILAB also
relies on external evaluations of our projects, which systematically
assess the relative effectiveness of different approaches or
combination of approaches. ILAB uses good practices, identified through
project experience and project evaluations, as a way to leverage
learning to promote greater impact in the countries where we work. The
following are just a few examples of the impact of ILAB's strategic
approach:
--In Uzbekistan, our strategy of consistent, multi-year diplomatic
engagement coupled with programming on a broad labor rights/
decent work agenda helped achieve a radical reduction in the
country's use of forced labor in the cotton sector;
--In Honduras, we have used a multidisciplinary approach--research on
labor issues, monitoring, and technical assistance and
cooperation--to holistically and sustainably advance labor
rights, including child labor, freedom of association,
collective bargaining, minimum wages, hours of work, and
occupational safety and health (OSH). With support from an
ILAB's project, three Honduran cooperatives that export coffee
to the United States implemented a sustainable social
compliance system to reduce the prevalence of child labor in
their supply chain.
--In Mexico, we have focused research and technical assistance
efforts in the agriculture sector and on goods where there is
high risk of child labor, forced labor, and other labor
violations. ILAB has used strategic engagement to empower
workers and civil society organizations to advocate for
increased access to education and social protection services
for children at risk of child labor, their families, and
migrant workers.
Question. What are the specific plans to address the worst forms of
child labor in the cocoa supply chain in West Africa and build on prior
investments made toward this objective?
Answer. The recent release of the ILAB-funded, NORC (formerly the
National Opinion Research Center at the University of Chicago) report
on child labor in cocoa-growing areas of Cote d'Ivoire and Ghana
underscores the significant challenges remaining in the sector. ILAB
recognizes that moving toward large-scale reduction of child labor in
the cocoa supply chain will require securing a commitment to broader
action by the two West African governments and the International
Chocolate and Cocoa Industry, including to improve labor monitoring,
better regulate the sector, and expand remediation efforts. Current
ILAB programming is supporting efforts to build the capacity of cocoa
cooperatives to enhance child labor monitoring in the cocoa supply
chain and facilitate enforcement of child labor laws. ILAB is also
funding programming to help law enforcement, private sector due
diligence monitors, social service and civil society organizations, and
workers themselves to prevent, detect, and eliminate forced labor and
labor trafficking in supply chains.
During the most recent meeting of the Child Labor Cocoa
Coordinating Group (CLCCG)--a group established in 2010 under the
Declaration and Framework-- in May 2021, the Governments of Cote
d'Ivoire and Ghana, the International Chocolate and Cocoa Industry and
ILAB agreed on the need to continue to coordinate on joint efforts to
reduce child labor in the cocoa sector. ILAB is currently engaged in
dialogue with the two governments and industry on ways to (1) expand
this partnership to include other donor governments (e.g., the E.U.)
and organizations; (2) promote more active engagement with worker
organizations and civil society actors; (3) expand the scope of efforts
to include a greater focus on forced labor and human trafficking and
the advancement of decent work; (4) take good practices to scale and
increase support to children and families in more remote areas where
NORC research found the most significant increase in child labor; and
(5) increase transparency and develop and report more regularly on
indicators of progress.
ILAB will also continue to report on child labor and forced labor
in Cote d'Ivoire and Ghana in its three flagship reports--the Findings
on the Worst Forms of Child Labor, the List of Goods Produced by Child
Labor or Forced Labor, and the List of Products Produced by Forced or
Indentured Child Labor. In addition, ILAB continues to engage in active
dialogue with other U.S. government agencies, such as the State
Department, USAID, USDA, MCC, and DHS/CBP on efforts to combat child
and forced labor in the cocoa sector and potential opportunities for
enhancing interagency coordination and collaboration.
ofccp enforcement
Question. Mr. Secretary, the Department of Labor plays a unique and
vital role in Federal contracting policy through the Office of Federal
Contract Compliance Programs to protect workers' rights on jobs created
by Federal contracting. These critical protections ensure the Federal
Government is creating a fair and safe workplace when it does business
with the private-sector. And I'm pleased to see that the Biden
Administration has placed such a substantial emphasis on these
protections, including a guarantee of a $15 an hour minimum wage.
Mr. Secretary--how would your Department use the funds requested
for OFCCP to vigorously enforce anti-discrimination, safety, pay, and
other important protections for workers on Federal contracts?
Answer. OFCCP would use the $140,732,000 in funds requested for
fiscal year 2022 to rebuild its workforce, strengthen its enforcement
to remove systemic barriers to equal opportunity, advance workplace
equity, increase contractor accountability, and invest in its
technological infrastructure. An investment of critically needed
resources will enable OFCCP to play a powerful role in advancing
President Biden's commitment to equity by addressing employment
inequities that have denied opportunities to vulnerable workers.
Rebuilding Workforce
The fiscal year 2022 OFCCP funding request is $140,732,000 and 639
FTE. This includes a program increase in the amount of $34,756,000 and
188 FTE to rebuild OFCCP's workforce. Over the past 4 years, OFCCP's
staffing levels have dropped significantly. In fiscal year 2020, OFCCP
operated with a staffing level of 452 full-time equivalents (FTE)
compared to 755 in fiscal year 2011.
Strengthening Enforcement
Specifically, the agency will focus on identifying ways to
strategically allocate our limited resources on comprehensive
compliance evaluations that identify and remedy systemic issues
including in hiring and pay, especially as our economy begins to
rebuild. Our approach has often been data driven to identify
disparities, but OFCCP is interested in developing strategic approaches
to identify issues that do not lend themselves to the same kinds of
statistical analysis, such as discrimination against workers with
disabilities and LGBTQ+ workers.
OFCCP will also focus on reinvigorating its compliance program for
Federal construction contractors and subcontractors and federally
assisted construction contractors and subcontractors. This effort will
be instrumental for the Department to ensure equal employment
opportunity for good jobs in the construction industry. OFCCP plans to
launch an outreach and education campaign to advance equity in
construction contractor workplaces and to educate workers of their
rights under the mandates enforced by OFCCP.
On its regulatory agenda, OFCCP listed its intention to modernize
its supply and service regulations. OFCCP is interested in updating its
requirements to align them with the realities of today's workforce and
how employers operate. The agency is considering how it can streamline
its processes and reduce unnecessary burdens on contractors while
ensuring OFCCP can comprehensively address indicators of discrimination
across all its authorities.
Workplace Equity Initiative
The funding request would support OFCCP developing a comprehensive
initiative to advance all forms of equity at work. President Biden has
made a historic commitment to advancing equity, prioritizing it as a
key pillar of his Administration. OFCCP has a critical opportunity to
work with a broad coalition of stakeholders in the pursuit of a common
goal--to eliminate discrimination in the workplace and proactively
advance equality of opportunity for all workers, including women,
people of color, LGBTQ people, people with disabilities, veterans, and
people belonging to multiple protected classes.
The purpose of this initiative is to identify promising practices,
evidenced-based research, and innovative initiatives that can lead to
more diverse, equitable, and inclusive workplaces that increase equity
in employment opportunities. In particular, the initiative will focus
on examining employment practices that have been effective in closing
pay gaps, increasing the recruitment and hiring of underrepresented
workers, and facilitating the promotion of underrepresented workers
into senior-level and executive positions.
Technology Modernization
In fiscal year 2022, OFCCP will continue to prioritize expediting
the modernization of its technology to promote greater employer
compliance while maximizing the efficiency of agency staff. This
includes completing OFCCP's Compliance Management System (CMS)
development and deploying the Notification Construction Award Portal
(NCAP), which allows Federal procurement officers, States, and
construction contractors and subcontractors to electronically notify
OFCCP of constructions awards valued at $10,000 or more. This IT
modernization effort centralizes the notification process in the
national office, increasing field efficiencies by relieving staff from
having to manage contract award notifications
Question. Please describe your hiring plans for the proposed
investments in OFCCP included in your budget request.
Answer. This funding request specifically supports the hiring,
retention, and training of a highly qualified and diverse workforce to
support OFCCP in advancing its mission through enforcement, outreach
and education, stakeholder engagement, and compliance assistance while
emphasizing efficiency, productivity, and accountability throughout the
organization. The support for additional staff will enable OFCCP to
strengthen its capacity to conduct compliance evaluations, and identify
and resolve instances of systemic discrimination in hiring and pay.
OFCCP is actively hiring to fill critical vacancies the agency lost
over the course of several years, especially compliance officers. OFCCP
is strengthening its internal capacity to support the hiring surge by
filling the vacant HR Branch Chief position and hiring additional
management analysts to support the agency's hiring and employee
engagement needs. To expedite the hiring process, OFCCP is utilizing
standardized position descriptions, single vacancy announcements for
multiple positions at various locations, and an array of hiring
authorities, including the Recent Graduate authority for entry level
positions. In addition, OFCCP encourages its employees to share
announcements through their professional and social networks. OFCCP is
also working with OHR to reach a diverse talent pool for its vacancy
announcements.
OFCCP is developing several new training courses and resources for
its compliance officers. With the recent OMB approval of the
construction scheduling letter and the upcoming release of the
construction scheduling list, OFCCP will ensure that its compliance
officers are fully trained to handle construction compliance
evaluations in the most efficient and effective manner. This training
is scheduled to commence prior to the release of the scheduling list.
OFCCP is also developing training for new compliance officers. The
training will cover the foundational topics a new compliance officer
must know in order to successfully start performing their job, such as
relevant legal authorities, policies, enforcement authorities,
compliance evaluations, complaint processing, and compliance
assistance. This training will be ongoing for all cohorts of new
compliance officers as the agency continues to hire.
The training OFCCP provides to its compliance officers allows them
to communicate agency standards and processes through compliance
assistance and apply those standards and processes during compliance
evaluations and complaint investigations. A uniform training program
ensures consistency in training across the regional offices, which is
critical in following OFCCP's regulations, processes, and procedures
and carrying out the agency's mission. OFCCP will continue to
prioritize investing in compliance officer training as the agency
rebuilds and hires.
osha farmworker safety
Question. Under a longstanding appropriations rider of more than 40
years, farms with fewer than 10 employees at all times during the prior
year and no temporary labor camp within the previous 12 months are
exempt from enforcement of all rules and requirements of the
Occupational Safety and Health Act. Yet, according to the National
Institute of Occupational Safety and Health, agriculture ranks as one
of the most dangerous industries, with farmers at a very high risk for
fatal or non-fatal injuries. Any worksite fatality is unacceptable and
every step must be taken to avoid such tragic loss of life.
How would the Occupational Safety and Health Administration (OSHA)
use Federal funds to improve farmworker safety if Congress removed this
rider in the fiscal year 2022 appropriations bill for the Department of
Labor? Please describe compliance assistance it would undertake, as
well as how farms would be factored into planned enforcement
activities, including any emphasis programs or directives.
Answer. The existing appropriations rider has precluded OSHA from
conducting enforcement activities at a farming operation if it: (1)
employs 10 or fewer non-family member employees currently and all times
during the preceding twelve months and (2) has not had an active
temporary labor camp during the preceding twelve months. If Congress
removes the rider, OSHA can respond to imminent danger situations at
currently exempt farming operations and remove employees from those
dangers. The agency would also be able to respond to employee
complaints regarding workplace safety and health hazards, and
investigate fatalities (such as from grain engulfment) and severe
injuries. Lastly, OSHA would include small farming operations in
programmed or planned inspections, such as national, regional, and
local emphasis programs, that are aimed at specific high-hazard
industries.
While the appropriations rider has significant implications for
OSHA's enforcement activity, it should first be noted that it has not
prevented the agency from developing and distributing workplace safety
and health resources for agricultural settings, including those where
OSHA is unable to conduct enforcement. For example, OSHA maintains an
Agricultural Operations Safety and Health Topics Page with information
about hazards related to grain bins and silos, hazard communication of
chemicals, noise, musculoskeletal injuries, heat, and others. OSHA also
has a plethora of publications in both English and Spanish that are
relevant to agricultural operations that may be printed from the
agency's website directly or ordered free of charge from our
Publications Office.
The agency also conducts significant outreach to the agricultural
industry as a whole, and engages with agricultural industry
stakeholders whose target audiences include small agricultural
workplaces and family-operated farms. For example, following a
significant increase in fatal grain engulfments between fiscal year
2015 and fiscal year 2016, OSHA's Regions 5, 6, 7, and 8 launched a
``Stand-Up for Grain Engulfment Prevention'' event in fiscal year 2017.
That same year, OSHA signed an Alliance with the National Grain and
Feed Association, which helped to expand the Grain Stand-Up. Two
additional organizations, the Grain Elevator and Processing Society
(GEAPS) and Grain Handling Safety Coalition (GHSC), have since joined
the Alliance and lent their resources to expanding this initiative.
GHSC, in particular, has played a key role in ensuring the Grain Stand-
Up reaches smaller growers/producers over which OSHA does not have
jurisdiction.
If the rider were removed, and funds became available, OSHA could
greatly expand its outreach to smaller agricultural employers and
workers. Staff could pursue new relationships with Federal and state
farm associations, and proactively establish alliances for the express
purpose of conducting outreach, developing educational materials, and
providing workplace safety and health training opportunities to smaller
farm owners, operators, and employees. Removal of the rider would also
enable OSHA to expand its On-Site Consultation Program to provide no-
cost workplace safety and health services to smaller agricultural
operations who were previously not eligible for these services.
Information collected during OSHA's inspections (e.g., regarding types
and location of fatalities in smaller farm operations) could also be
used to strengthen, and more effectively target, outreach and
compliance assistance.
Question. How would OSHA use Federal funds to improve farmworker
safety if Congress were instead to modify the rider by allowing the
fiscal year 2022 appropriation to be used only to investigate
fatalities on such small farms and provide associated compliance
assistance necessary to decrease the likelihood of a similar injury or
fatality?
Answer. Farming operations experience workplace fatalities from a
variety of hazards, including from grain engulfment, falls from
structures, entanglement in grain moving machinery, and electrocution.
Researchers with the Agricultural Safety and Health Program of Purdue
University publish a report yearly, showing trends in the number of
grain entrapments and associated fatalities. Because small farming
operations are exempt from OSHA enforcement activities, OSHA cannot
investigate such incidents and determine the root causes to prevent
recurrence of such incidents. If Congress modifies the rider, OSHA can
inspect and thoroughly investigate the fatalities, and provide
necessary abatement methods and hazard recognition training to
employers engaged in small farming operations.
We assume that the provision of the direct compliance assistance
would be limited to the employers involved in the fatalities
investigated, and focused on decreasing the likelihood of a similar
injury or fatality at that facility. In this case, the agency would
continue the outreach it already engages in (noted above) but could not
meaningfully expand proactive outreach and compliance assistance to
smaller farm operations. In many instances, when OSHA responds to a
fatality in an agricultural operation and determines that it has no
enforcement jurisdiction (e.g., where an incident is voluntarily
reported), the responding staff will nevertheless advise them that
there is important safety and health information on the OSHA website
that could help them to decrease the likelihood of a similar injury or
fatality. However, the agency could enhance this effort by using the
findings gathered through any resulting investigations to augment
existing compliance assistance materials and share them broadly through
its outreach efforts. The agency may also be able to engage with the
individual employers through the On-site Consultation program; this
would need to be evaluated at the time the rider is issued.
multilingual worker protection staff
Question. The missions of worker protection agencies of the
Department of Labor include coverage of and assistance to all workers,
including those who speak languages other than English.
Please provide current counts of the number of multilingual staff
for the Wage and Hour Division (WHD) and Occupational Safety and Health
Administration (OSHA) in total and by region.
Answer. OSHA has a total of 111 staff who are multilingual. The
breakout by region is shown in the table below.
------------------------------------------------------------------------
OSHA Multilingual Staff 2021
-------------------------------------------------------------------------
Region Staff
------------------------------------------------------------------------
1 4
------------------------------------------------------------------------
2 4
------------------------------------------------------------------------
3 8
------------------------------------------------------------------------
4 14
------------------------------------------------------------------------
5 38
------------------------------------------------------------------------
6 14
------------------------------------------------------------------------
7 16
------------------------------------------------------------------------
8 0
------------------------------------------------------------------------
9 7
------------------------------------------------------------------------
10 4
------------------------------------------------------------------------
National Office 2
------------------------------------------------------------------------
Total 111
------------------------------------------------------------------------
These data were provided by the Office of the Assistant Secretary
for Administration and Management and includes positions that may
require a foreign language capability.
In total, WHD has 573 employees who are multilingual and speak 21
different languages.
By Region, the Northeast Region has 136 multilingual staff, the
Midwest Region has 87 multilingual staff, the Southeast Region has 107
multilingual staff, the Southwest Region has 117 multilingual staff,
and the Western Region has 126 multilingual staff.
Question. How will the Department use resources in the current
fiscal year and requested for fiscal year 2022 to recruit and hire
multilingual, qualified candidates for roles as investigators,
inspectors and other critical positions where language barriers could
prevent an agency from fulfilling its statutory mission? How will the
Department assess such language gaps and plan to meet its language
needs in carrying out the missions of its agencies?
Answer. OSHA plans to recruit and hire multilingual qualified
candidates for investigators, inspectors and other positions by working
with organizations such as Historically Black Colleges and
Universities, Hispanic Serving Institutions, the Asian American Network
and other organizations so that the agency's workforce has the
multilingual capabilities that reflects the communities that OSHA
serves. By reaching the most hazardous worksites and facilities, the
agency not only helps secure safe and healthy workplaces and reduce
workplace injuries, illnesses, and deaths, but also protects at-risk
workers in marginalized communities, who are less likely to have the
protections and training to work safely in high-hazard workplaces.
The Wage and Hour Division (WHD) utilizes targeted recruitment
strategies to attract a diverse pool of highly qualified candidates for
WHD positions. WHD routinely includes language requirements when hiring
to ensure that investigators can successfully communicate with workers
and employers about their rights and responsibilities under the law.
Currently, WHD has more than 570 multilingual staff.
In fiscal year 2022 WHD will continue to assess hiring needs
through a data-driven approach that will help to identify gaps in
services and resource allocation to particular communities. WHD is
implementing plans to increase recruitment and outreach to Minority
Serving Institutions and community based organizations to continue to
reach diverse applicants and ensure a pipeline of investigators who
reflect the communities they serve. Finally, WHD is opening positions
in remote, low-wage, underserved communities nationwide and increasing
flexibility in telework to serve these areas.
Question. Please describe how the WHD and OSHA will work with
stakeholders, including community-based organizations in reaching
worker populations such as those with language access barriers and
other factors that may contribute to a decreased likelihood of filing
of a complaint for a violation of labor law protections.
Answer. OSHA remains committed to working with and engaging its
whistleblower stakeholders. The agency has been conducting two
stakeholder meetings per year, some targeting specific industries,
seeking input and suggestions from them on a myriad of issues, such as
how to provide better customer service and how to conduct better
outreach to the public. The agency also listens to their concerns
regarding how the coronavirus pandemic has affected their workplaces.
The agency reviews each and every comment and suggestion from these
meetings and has implemented a number of them.
As a result of the most recent stakeholder meeting in May 2021,
OSHA is reaching out to migrant worker groups who provided comments, to
more fully understand their concerns, and to work with them on enhanced
ways to reach out to the people they represent. In addition, the
agency's whistleblower website, www.whistleblowers.gov, contains many
outreach documents that provide information to workers who may have
been retaliated against for engaging in protected activity. Much of the
information is available in English and Spanish.
The agency is committed to not only inform workers of their rights,
but also to remind employers of their responsibilities under these
laws. Moreover, OSHA is actively promoting its Recommended Practices
for Anti-Retaliation Programs guidance document, which focuses on
assisting employers in creating an effective anti-retaliation program
in their workplaces, where workers feel comfortable reporting concerns
without fear of retaliation, and without the need to file a
whistleblower complaint in the first place.
OSHA continues to prioritize outreach to vulnerable worker
populations. For example, OSHA translated its educational and outreach
materials into Spanish \1\ and more than 30 other languages.\2\ These
resources are printable from OSHA's website and print copies may be
shipped at no cost upon request. Several focus specifically on
workplace rights \3\ and OSHA created a video on filing a complaint
that is available in both English \4\ and Spanish,\5\ which is shared
along with its publications through the agency's outreach efforts.
---------------------------------------------------------------------------
\1\ https://www.dol.gov/newsroom/releases/odep/odep20200429-0.
\2\ https://www.osha.gov/publications/bylanguage.
\3\ https://www.osha.gov/publications/bytopic/workers'-rights-
outreach.
\4\ https://www.youtube.com/watch?app=desktop&v=k70Ln7gRWDE.
\5\ https://www.youtube.com/watch?app=desktop&v=zgv-Fuqx3K4.
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OSHA's Labor Liaisons \6\ maintain communication with organized and
unorganized workers, Committees on Occupational Health and Safety,
worker centers and coalitions, helping them navigate OSHA's
organizational structure and complaint procedures, and assisting them
in developing and updating health and safety programs.
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\6\ https://www.osha.gov/workers/liasons.
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The agency maintains regular communication with worker advocacy
organizations such as the National Council for Occupational Safety and
Health (National COSH), to ensure that safety concerns workers have
about their jobs are heard and addressed. On June 23, 2021, Acting
Assistant Secretary Jim Frederick participated in a bilingual town hall
meeting where he responded directly to questions from farm, poultry
plant, nursing home and other workers. Topics included the urgent need
to protect workers from heat exposure and the COVID-19 Emergency
Temporary Standard for healthcare. The recording is available in
English here \7\ and in Spanish here.\8\
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\7\ https://drive.google.com/file/d/
1HFikHihuIMbB69LGgdNsRsVkWCINtOXG/view.
\8\ https://drive.google.com/file/d/1gbM7sdTTonaNEGaMP-
PVO3Itdpf3uoH4/view.
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OSHA has numerous regional and area office alliances with
Consulates \9\ of Mexico and other Latin American countries through
which the agency shares information in English and Spanish about
workplace safety and health hazards and workers' rights, including use
of the OSHA complaint process. OSHA's Region 5 Regional Office also has
an Alliance with the Consulate of the Philippines in Chicago.
---------------------------------------------------------------------------
\9\ https://www.osha.gov/alliances/byemphasis#consulate-alliances.
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OSHA Compliance Assistance Specialists participate in regional task
forces and committees established to protect migrant farmworkers in
both the midwest and southeastern United States. Each August, OSHA and
WHD collaborate in supporting Labor Rights Week, a joint initiative
between the governments of the United States and Mexico to increase
awareness in the Mexican and Latino communities about the rights of
workers, including immigrant workers.
WHD is currently engaged in the Essential Workers, Essential
Protections initiative, which includes collaborating with stakeholders
nationwide to train them in protections for the most vulnerable, at-
risk worker populations as we emerge from the pandemic. Efforts to date
include conducting hundreds of educational webinars, reaching more than
26,000 participants; training advocates on how to file complaints;
producing and continuing to air television and radio public service
announcements in English and Spanish; and producing and placing
workers' rights posters in local stores to reach marginalized
populations. A nationwide series of listening sessions is now underway
to hear directly from stakeholders in contact with these workers how we
can better reach them. These efforts are designed to strengthen
relationships with community based organizations who are trusted
resources for the most vulnerable workers and can refer workers, file
third-party complaints, and amplify WHD's enforcement efforts.
subminimum wage
Question. The budget requests $42.7 million, an increase of $3.7
for the Office of Disability Employment Policy (ODEP). The budget notes
a priority for ODEP to advise Federal agencies and assist states and
employers in transitioning workers away from sub-minimum wage
employment currently authorized under 14(c) of the Fair Labor Standards
Act to competitive, integrated employment. My home state of Washington
recently enacted legislation ending a similar authority for issuing
certificates to pay workers with a disability less than the state
minimum wage generally as of July 31, 2023.
Please identify the Federal agencies involved and describe the
planned advisements that ODEP has for this and next year.
Answer. ODEP works with multiple Federal agencies to advance
competitive integrated employment (CIE) in order to reduce reliance on
Section 14(c) certificates. CIE is employment that pays at least the
Federal minimum wage (or state minimum wage when higher) and allows an
employee with a disability to interact with people without disabilities
to the same extent able-bodied employees interact with one another. The
main Federal agencies ODEP collaborates with include:
--AbilityOne
--Department of Labor (DOL), Office of Federal Contract Compliance
Programs (OFCCP)
--DOL, Employment and Training Administration (ETA)
--DOL, Employee Benefits Security Administration (EBSA)
--DOL, Veterans' Employment and Training Services (VETS)
--DOL, Wage and Hour Division (WHD)
--Department of Education (ED), National Institute on Disability
Independent Living, and Rehabilitation Research (NIDILRR)
--ED, Office of Career Technical and Adult Education (OCTAE)
--ED, Office of Special Education and Rehabilitation Services (OSERS)
--ED, Office of Special Education Programs (OSEP)
--ED, Rehabilitation Services Administration (RSA)
--Department of Health and Human Services (HHS), Administration for
Community Living (ACL)
--HHS, Centers for Medicare and Medicaid Services (CMS)
--HHS, Substance Abuse and Mental Health Services Administration
(SAMHSA)
--Social Security Administration (SSA)
--Department of Veterans Affairs (VA), Veterans Health Administration
(VHA)
--VA, Veterans Readiness and Employment (VRE)
ODEP planned activities and advisements for this year and next year
to promote CIE: In fiscal year 2021, ODEP is investing significant
effort \10\ to advance national and state-level policy promoting CIE to
reduce reliance on Section 14(c) certificates. ODEP maintains a list of
state ``Employment First'' policies and initiatives aimed at phasing-
out Section 14(c). The list is readily available to share with Federal
agencies, state partners and other stakeholders on request. ODEP
maintains a learning library of webinars and resources focused
specifically on advancing CIE and has worked directly in over 27 states
to align state policy, funding and service strategies to incentivize
integrated over segregated employment. ODEP remains a resource for
Federal agencies and state/local systems on use of best practices for
achieving CIE, such as supported and customized employment, and
reasonable accommodations. In designing activities to advance CIE and
eliminate Section 14(c) employment, ODEP organized the recommendations
of the Advisory Committee on Increasing Competitive, Integrated
Employment for Individuals with Disabilities (ACICIEID) into 10
critical areas. These 10 areas are needed for employment service
providers and systems to transform their systems from segregated to
competitive integrated business models and provide the overarching
framework for ODEP's work. Based on this framework, ODEP created a
Transformation Guide for states to assist in organizing the multiple
aspects of transformation needed across policy, funding and practice to
achieve CIE.\11\ Specific ODEP activities and advisements for fiscal
year 2021-2022 include:
---------------------------------------------------------------------------
\10\ https://www.dol.gov/agencies/odep/program-areas/integrated-
employment.
\11\ http://drivedisabilityemployment.org/employment-first-
resources/e1st-state-transformation-guide.
---------------------------------------------------------------------------
--National Expansion for Employment Opportunities Network (NEON):
ODEP's NEON project assists provider agencies to increase CIE
outcomes and thus reduce reliance on Section 14(c) employment.
In fiscal year 2020, NEON selected and worked with five
national provider organizations (NPOs): ACCESS, the American
Network of Community Options and Resources (ANCOR), the
Association of People Supporting Employment First (APSE), the
Arc US and SourceAmerica. ODEP helped the NPOs create national
strategic plans for their employment provider networks to
transition away from Section 14(c) strategies and increase CIE
outcomes. Through NEON, ODEP also supported 19 local provider
organizations (LPOs) transition to CIE in fiscal year 2020. In
fiscal year 2021, NEON is assisting 48 providers in 19 states,
including Washington state. ODEP is also working through NEON
to create a National Plan to Increase CIE within the provider
community (anticipated for release in late 2021). In addition,
ODEP manages a monthly Community of Practice bringing national
experts, promising practices and real-life examples of provider
transformation to the over 2,700 participants from every state.
In fiscal year 2022, NEON will support up to 75 LPOs with
transition to CIE, and will provide support and technical
assistance to implement the NEON National Plan to Increase
CIE.\12\
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\12\ https://www.dol.gov/newsroom/releases/odep/odep20200429-0.
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--Advancing State Policy Integration for Recovery and Employment
(ASPIRE): Established in fiscal year 2021, ODEP's ASPIRE
initiative provides technical assistance to seven states to
help them develop and align policies, funding and service
strategies to increase CIE for people with mental health
conditions. Each state is required to involve key systems that
provide employment service and support including: Vocational
Rehabilitation, Mental/Behavioral Health, Medicaid and
Workforce Development. ASPIRE's goal is to coordinate policy,
funding and service strategies to increase availability of
evidence-based supported employment opportunities for people
with mental health conditions in the state. A technical working
group (TWG) composed of national mental health stakeholder
organizations, mental health national experts and intermediary
associations of state and local government agencies provide
ongoing information and assistance to ASPIRE states. In
addition, a supported employment learning community meets
monthly to bring cutting-edge information on key issues in
supported employment implementation to ASPIRE states. In fiscal
year 2022, ODEP will expand the number of states included in
ASPIRE, and will utilize its State Exchange on Employment and
Disability (SEED) to increase state policy alignment across
systems to increase CIE for people with mental health
conditions.\13\
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\13\ https://www.dol.gov/agencies/odep/initiatives/aspire.
---------------------------------------------------------------------------
--ODEP's work with VA and DOL VETS on CIE for Veterans with
Disabilities: In fiscal year 2021, ODEP partnered with the VA's
VRE and VHA and DOL's VETS to develop and release two videos to
raise awareness about customized employment as an effective
strategy to help veterans with disabilities move from sheltered
employment or unemployment into CIE. Released in February 2021,
the videos are available at: Customized Employment Works for
Veterans: A Job That I Love \14\ and Customized Employment
Works for Veterans: A Win-Win Strategy.\15\
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\14\ https://www.youtube.com/watch?app=desktop&v=xIsekJpeyiw.
\15\ https://www.youtube.com/watch?app=desktop&v=5CFjKwJtXqc.
---------------------------------------------------------------------------
--ODEP work on Rate Rebalancing to Incentivize CIE: In May 2021, ODEP
released a comprehensive policy guide on state rate
reimbursement restructuring titled ``Value-Based Payment
Methodologies to Advance Competitive Integrated Employment: A
Mix of Inspiring Examples from Across the Country''. Guidance
on rate reimbursement restructuring is critical to increasing
CIE for people with significant disabilities. Many existing
rate structures are based on the assumption that some people
with disabilities are incapable of work, rather than on an
Employment First framework that assumes all people are capable
of work if given the necessary supports, accommodations and
work environment. ODEP developed three webinars on rate
restructuring in which relevant state agencies (Medicaid,
Vocational Rehabilitation, Mental/Behavioral Health) and
providers discuss how adjusting service rates enabled them to
incentivize CIE over segregated work models. This is important
because some state systems may reimburse providers higher
amounts for segregated outcomes. These systems could instead
elect to include services necessary for CIE in their list of
covered services and incentivize their use through higher
reimbursement rates. The webinars providing examples from
multiple states and multiple different systems include: (1)
Value, Outcome and Performance-Based Payment Methodologies to
Advance Competitive Integrated Employment in State Medicaid
Long-Term Services and Supports (LTSS) Systems and Managed Care
LTSS Systems; (2) Supporting Employment Service Providers to
Succeed and Prosper by Partnering to Advance Competitive
Integrated Employment: Applying Value, Outcome and Performance-
Based Payment Methodologies; and (3) Advancing Competitive
Integrated Employment: Value, Outcome and Performance-Based
Payment Methodologies in State Vocational Rehabilitation and
Behavioral Health Systems.
--Financial Literacy and Benefits Planning through the Lifespan:
Financial Literacy Toolkit: ODEP also worked with DOL's EBSA to
develop a toolkit for youth and adults with disabilities to
assist with their finances as they consider employment,
retention and advancement. It also shows them how they can
build savings. This toolkit provides valuable information for
all phases of employment, including consideration of the impact
on benefits from working as people with disabilities move from
sheltered settings to CIE. It provides information in essential
areas such as work incentives, Achieving a Better Life
Experience (ABLE) accounts, and other areas of financial
literacy essential for people with disabilities. For example,
one important resource is the new fact sheet on the Medicaid
buy-in, developed by ODEP in collaboration with ACL and CMS
(see Medicaid Buy-In Q&A Medicaid ``Buy-In'' Q&A
(dol.gov)).\16\ ODEP will continue to develop new resources in
this area and add them quarterly. On July 27, ODEP and EBSA
hosted a webinar, Secure Your Financial Future: A Toolkit for
Individuals with Disabilities,\17\ to launch this new financial
literacy toolkit.\18\ I provided welcoming remarks for the
webinar.
---------------------------------------------------------------------------
\16\ https://www.dol.gov/sites/dolgov/files/odep/topics/
medicaidbuyinqaf.pdf.
\17\ http://leadcenter.org/webinars.
\18\ https://www.dol.gov/agencies/ebsa/secure-your-financial-
future.
---------------------------------------------------------------------------
--Workforce Innovation and Opportunity Act (WIOA) Workforce
Development System: ODEP efforts to expand access to CIE
includes leveraging the services and connections available
through the American Job Centers (AJC) system operated under
WIOA. AJCs can register to become Employment Networks (ENs)
under the Ticket to Work (TTW) program. ENs are reimbursed for
employment services on a milestone basis for successfully
assisting people with disabilities into CIE employment.
Consequently, ODEP worked to expand the impact of the TTW/EN
program by connecting providers of CIE employment services to
ENs. The goal was to leverage additional support in achieving
CIE for people with disabilities who are eligible Social
Security recipients under TTW. To assist in this effort, on May
2021, DOL released a Ticket to Work: Operating a Workforce EN
Planning Guide and Workbook to promote the benefits of
operating as a workforce EN and to enhance awareness of
available resources to help in this process, including guidance
and promising practices. ODEP, ETA and SSA developed this
technical guide with input from 19 workforce systems currently
operating as ENs. The planning guide and workbook assist state
and local area workforce leadership in the process of becoming
and operating as a workforce EN. It includes a set of
activities (e.g., checklists, discussion questions and
exercises) to help walk through the process to make an informed
decision, and serve as an operational resource for existing
workforce ENs. ODEP also held a webinar on May 26, 2021,
Practices in Workforce Employment Network Operation--New
Technical Guidance,\19\ which provided highlights from the
technical guide, promoted the advantages this opportunity
provides to local workforce systems and shared the experiences
of three current workforce systems from the workforce EN
operators.
---------------------------------------------------------------------------
\19\ https://www.workforcegps.org/events/2021/03/23/13/16/
Practices-in-Workforce-Employment-Network-Operation-New-Technical-
Guidance.
---------------------------------------------------------------------------
--Advisement to Federal State and Local Governments, Providers and
Individuals with Disabilities on Current Federal Investments to
Advance CIE: In July 2021, in recognition of the 31st
anniversary of the Americans with Disabilities Act, ODEP
released a new fact sheet, ``Recent Funding Opportunities to
Expand Access to Competitive Integrated Employment (CIE) for
Individuals with Disabilities'', developed in collaboration
with the HHS' CMS, ACL, SAMHSA; ED's RSA and OSEP; and SSA. The
fact sheet highlights new funding and flexibilities which
provide significant opportunities to increase access to CIE for
youth and adults with disabilities. The increased funding and
flexibilities are provided under the Coronavirus Aid, Relief
and Economic Security Act (CARES), the American Rescue Plan Act
of 2021 (ARP), the Coronavirus Response and Relief Supplemental
Appropriations Act (CRRSA), the Further Consolidated
Appropriations Act of 2020 (FCAA), and through the work of
multiple Federal agencies providing services to individuals
with disabilities. The CIE fact sheet is located on the ODEP
web page at: Recent Funding Opportunities to Expand Access to
Competitive Integrated Employment (CIE) for Individuals with
Disabilities.\20\
---------------------------------------------------------------------------
\20\ https://www.dol.gov/sites/dolgov/files/ODEP/pdf/
508_odep_cie_07152021.pdf.
---------------------------------------------------------------------------
--Disability Innovation Fund: ED's RSA and ODEP are discussing RSA's
2020 and 2021 Disability Innovation Fund, which currently has
approximately $110 million in fiscal year 2020 available
funding, resulting from unused Federal vocational
rehabilitation funding returned by states. Congress directed
RSA to consult with DOL regarding the use of fiscal year 2021
funds. For the fiscal year 2021 funds, Congress stipulated that
the funds be used to award competitive grants to improve
opportunities for CIE for individuals with disabilities. ODEP
is working with WHD, RSA, ACL and CMS to design the next set of
grants.
Question. How does ODEP plan to assist states and employers in such
transitions?
Answer. ODEP remains committed to helping states and employers
transition from segregated Section 14(c) employment to CIE outcomes.
ODEP's most critical activities include NEON, ASPIRE, and a new
collaboration between ODEP's SEED initiative with ASPIRE and NEON.
--National Expansion for Employment Opportunities Network (NEON): As
described above, ODEP's NEON project assists provider agencies
to increase CIE outcomes and thus reduce reliance on Section
14(c) employment. In fiscal year 2022, NEON will increase the
number of providers developing and implementing transformation
plans and assist states in the critical task of rebalancing/
aligning their service funding in support of CIE. ODEP is also
developing multiple NEON tools for release. These include, but
are not limited to: an Employment First statewide strategic
planning manual to assist states in organizing their statewide
strategic planning efforts to effectively engage stakeholders
and implement Employment First systems change and a state self-
assessment tool for increasing CIE to assist states in
evaluating current policies, practices and infrastructures in
each of the Ten Critical Areas to Increase Competitive
Integrated Employment. The 10 sections of the assessment tool
are based on the recommendations of the final report of the
Advisory Committee on Increasing Competitive Integrated
Employment for Individuals with Disabilities. Additional focus
in NEON fiscal year 2022 activities will assist providers in
implementing the NEON National Plan to Increase CIE (expected
release late 2021).
--Advancing State Policy Integration for Recovery and Employment
(ASPIRE): As described above, ODEP's ASPIRE initiative is
assisting states and providers with aligning policy, funding
and service strategies across systems This is needed to expand
access to evidence-based supported employment throughout
participating states. In fiscal year 2022, ODEP will expand the
number of states included in ASPIRE, and will collaborate with
ODEP's SEED initiative to increase state policy alignment
across systems in other states to increase CIE for people with
mental health conditions.
--State Exchange on Employment and Disability/ASPIRE/NEON
partnership: ODEP's SEED works through state intermediary
organizations such as the National Conference of State
Legislatures (NCSL), the National Governors Association (NGA),
and the Council of State Governments (CSG) to assist state
legislatures and governors in developing more inclusive
workforce policies that promote disability employment. Since
transitioning away from subminimum wage is a priority for DOL
and an increasing priority for states, SEED and its
intermediaries will actively promote legislative and
administrative policy options for consideration by all of the
states, as well as share examples of recently passed or enacted
legislation. In fiscal year 2022, SEED and its intermediaries,
including NGA, will work with ODEP's ASPIRE and NEON
initiatives to establish a policy collaborative that will focus
on assisting those states supporting CIE and the phase-out of
Section 14(c). States with more mature CIE policy in place will
participate as CIE leaders to assist states with less developed
CIE policy, and subject matter experts will work directly with
participating states to develop CIE transformation plans.\21\
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\21\ https://www.dol.gov/agencies/odep/state-policy.
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bls move
Question. The last two Department of Labor Appropriations Acts have
appropriated a total of $40 million requested for the move of the
headquarters of the Bureau of Labor Statistics (BLS). The Congressional
Budget Justifications for fiscal years 2020 and 2021 both identified
this amount as the share of total project costs that BLS would
contribute to the move, with the General Services Administration (GSA)
paying for the remainder of construction and real property costs of
nearly $50 million. The fiscal year 2022 BLS budget requests $28.5
million for a portion of these real property costs and indicates the
remaining costs would be initially financed by the GSA and repaid by
BLS over time after the move is complete.
Why has GSA backed out of paying its share of project costs?
Answer. The fiscal year 2020 Budget, released in March 2019,
announced that the BLS headquarters would move to the Suitland Federal
Center. At the time, based on a high-level assessment of the project,
the Budget estimated a total project cost of $89 million. The personal
property costs of $40 million were assigned to BLS, and GSA was
assigned the real property costs at $49 million. These estimates were
done in advance of a detailed building assessment study which expanded
the scope of the renovation project resulting in a new cost estimate
and a detailed assignment of costs between BLS and GSA. The fiscal year
2022 BLS budget request for $28.5 million reflects this revised cost
estimate and an updated determination that BLS would fund tenant
improvement costs, the costs to be borne by the agency consistent with
the publicly posted GSA pricing guide, through a combination of
appropriated dollars (paid up front) and a tenant improvement allowance
(repaid over time through the rent stream). GSA's fiscal year 2022
budget also reflects increased renovation costs with a request of $20
million in fiscal year 2022. GSA continues to fund all renovation costs
consistent with the pricing guide while BLS is funding the tenant
related costs consistent with projects in GSA owned facilities.
Question. What actions has DOL taken to secure the GSA contribution
that DOL stated in prior Congressional Budget Justifications GSA would
provide?
Answer. Throughout the project, DOL has worked closely with GSA to
refine cost estimates and clarify funding mechanisms. This has involved
numerous and regular meetings with GSA executives within the National
Capital Region, in consultation with the Office of Management and
Budget.
Question. Please describe how the $28.5 million requested for costs
that GSA was going to cover could instead be used to strengthen BLS
programs for measuring labor market activity, working conditions,
productivity and other critical information for understanding the
economy of the United States? What about the additional $23.8 million
in costs that would need to be repaid in the future?
Answer. As mentioned above, the fiscal year 2022 BLS budget request
for $28.5 million reflects the revised cost estimate to realize the
move with the associated reduced footprint and the long-term rent
savings for the BLS National Office. The Department strongly supports
the move, as it will produce considerable savings and efficiencies that
will contribute to BLS' achievement of its mission. If the BLS
appropriation for fiscal year 2022 instead directed the $28.5 million
in additional funding for base programs, the BLS could fund work on
additional statistical program improvements that have been of interest
to Congress, such as improving the Job Openings and Labor Turnover
Survey (JOLTS) and Consumer Expenditure (CE) program poverty
measurement. However, without this funding, the BLS Suitland move would
be interrupted and the project timeline would be prolonged.
Additionally, it is critical for work to proceed in a timely fashion as
the $40 million appropriated to date for the move expires September
2024. Once the BLS National Office is located at Suitland, rental
savings are expected, which could be used to cover the tenant
improvement costs to be repaid over time and future program
improvements.
The $23.8 million in estimated costs to be paid to GSA in the
future are intended to take place over the course of several years in
the form of a tenant improvement allowance. As such, the payments will
be part of the BLS rent bill at the Suitland Federal Center (SFC) and,
at that level, will reduce the expected rent savings at the SFC by
approximately $2.5 million per year.
whd and osha foia requests
Question. With over 1,700 Freedom of Information Act requests
backlogged at the Wage and Hour Division and more than 800 backlogged
at the Occupational Safety and Health Administration as of the second
quarter of fiscal year 2021, it's clear more needs to be done to timely
process these requests.
Please identify the funding and staffing level dedicated to this
work at each of these agencies in the current fiscal year and the
amounts and staffing level in the fiscal year 2022 request.
Answer. OSHA's FOIA program is decentralized, with designated staff
performing FOIA work largely as an additional duty in the national
office and field offices across the country, and does not have a
designated budget line item. The funding and staffing for OSHA's FOIA
work is calculated based on a survey on the number of staff involved
and amount of time spent working on the program. In fiscal year 2020,
eight FTE worked full-time on FOIA. Staff working on FOIA as an
additional duty accounted for the equivalent of 54 FTE, for a total of
62 FTE working on the FOIA program at a cost of $6.4 million.
In fiscal year 2021, the Wage and Hour Division had nine FTE at an
approximate cost of $1.1 million performing work related to the Freedom
of Information Act. In fiscal year 2022, the Wage and Hour Division
expects staffing levels to be 11 FTE for approximately $1.3 million to
perform this work.
Question. What steps are these agencies taking and planning to
timely process FOIA requests?
Answer. OSHA acknowledges that there is room for improvement in the
FOIA program and is working to address the backlog of requests and to
improve the timeliness of responses to new requests. OSHA processes
approximately 9,000 FOIA requests every fiscal year. This accounts for
approximately 60 percent of all FOIA requests that come into the
Department of Labor. OSHA's FOIA program is decentralized and consists
mainly of staff working on FOIA requests as an additional duty. OSHA's
Office of Communications (OOC) coordinates the agency's FOIA program
and routinely coordinates with staff working on FOIA throughout the
country to address any issues, share information, and provide necessary
training. OOC continuously looks for ways to improve the effectiveness
and efficiency of the FOIA program. For example, OOC has conducted two
pilots to evaluate potential changes to the program's structure in
order to streamline and improve overall efficiency, consistency and
quality of the agency's FOIA process. The agency is evaluating the
results of the pilots and is considering next steps.
During fiscal year 2021, the Wage and Hour Division has reduced its
FOIA back log from 530 outstanding requests at the end of fiscal year
2020 to 285 as of July 30, 2021. WHD has accomplished this by
recruiting and retaining FOIA leadership and staff as well as
leveraging technological tools to speed processing requested records
within WHD.
ebsa consolidated budget
Question. The budget request for the Employee Benefit
Administration (EBSA) requests a consolidated employee benefits
security programs budget activity in place of separate budget
activities for enforcement and participant assistance, policy and
compliance assistance, and administration.
How would this new structure better enable EBSA to achieve its
statutory mission?
Answer. EBSA seeks to aggregate and consolidate program budget
activities for enforcement and participant assistance, policy and
compliance assistance, and program oversight.
By restructuring these three budget activities into a single
activity for Employee Benefits Security Programs, EBSA can simplify
agency performance reporting and streamline agency performance and
operating plan development and implementation.
Question. How would EBSA continue to provide transparency and
oversight of its spending for each of the eliminated budget activities?
Answer. EBSA believes that restructuring its budget activities will
facilitate the allocation and redistribution of resources from lesser
performing and lower priority strategies/programs to better performing
and higher priority strategies/programs. The restructured budget
activities will create a responsive organization that facilitates
results-based management. Additionally, the restructured budget
eliminates artificial lines between activities, all of which are aimed
at a single outcome--employee benefits security. While this
restructuring would promote the more efficient allocation of resources,
it would not have any negative impact on EBSA's ability and
responsibility to report responsibly to Congress on how it expends
appropriated funds or on the agency's resulting performance.
research and evaluation funding
Question. The budget proposes new evaluation funding flexibility
for the Chief Evaluation Officer and Bureau of Labor Statistics at the
Department of Labor, as well as for certain offices within the
Department of Health and Human Services.
Please describe how each of the new authorities requested would
better advance research, evaluation and statistical purposes at the
Department of Labor.
Answer. High-quality evaluations, research, and statistical surveys
are essential to building evidence about what works, why, and for whom.
They are also inherently complicated, dynamic activities, with
uncertainty about the timing and amount of work required to design,
implement, and complete the studies. Further, we often want to know
about the outcomes for workers both in the short- and longer-term. This
usually requires information collections spanning five or more years
beyond the particular intervention or program under study. The proposal
allows flexibility to strategically plan evaluations over time by
extending the obligation period to 5 years, rather than constraining
obligation within 1-2 years (as current authorities for BLS or the
Chief Evaluation Office allow). In addition, the currently available
procurement vehicles lack the flexibility needed to match the dynamic
nature of these evidence-building projects. Some studies provide high
quality information useful across DOL sub-agencies or across Federal
agencies; the proposed authority to use a single Treasury account for
such activities, when multiple originating appropriations are used,
enables efficiencies for awarding contracts to evaluate DOL programs
when portions of funding from several DOL accounts are needed to
sufficiently fund the project, or when cosponsoring research across
Federal agencies. The proposed flexibilities enable DOL to maximize the
use of evaluation resources, reduce burden to the public, and mitigate
duplication of Federal efforts.
Further, evaluation and research projects often encounter
unexpected circumstances due to their dynamic nature. The proposed
authority would permit unexpended funds to be repurposed for another
research, evaluation, or statistical project, which is often not
currently possible because of the time-limited and inflexible nature of
these funds. This would allow the funds to be used efficiently for
their original intent. In order to streamline these procurement
processes, improve efficiency, and make better use of existing
evaluation resources the Budget proposes to provide the Department of
Labor with expanded flexibilities to spend funds over a longer period
of time through the ``Evaluation Funding Flexibility'' outlined in
General Provision, Section 521. This request is part of a provision
which includes the Departmental Program Evaluation activity in the
Departmental Management appropriation and the Bureau of Labor
Statistics; as well as the Department of Health and Human Services'
Assistant Secretary for Planning and Evaluation and the Office for
Planning, Research and Evaluation in the Administration for Children
and Families. These flexibilities will allow agencies to meet the
collective aim of efficient government investment in evidence-building
with embedded adaptability to reflect changing circumstances on the
ground.
wcf unobligated balances
Question.The budget proposes to increase the transfer authority
from unobligated balances available to the Secretary in fiscal year
2022 to the Working Capital Fund (WCF) from $18,000,000 to $36,000,000.
The budget also proposes to create a multi-year funding authority for
building space optimization within the WCF.
Please identify the additional investments that could be supported
by the increased transfer authority and describe the cost avoidance and
risk reduction expected to be achieved through these additional
projects.
Answer. The Department will use these funds to modernize a host of
legacy agency applications. DOL's 27 agencies have developed and
maintained distinct, customized systems and applications to meet the
unique requirements of their respective missions, but many of these
systems and applications are outdated and quite cumbersome by modern
standards. These legacy applications are costly to maintain,
inefficient for both Federal staff and the public to use, and are less
secure than modernized alternatives.
The Department is well prepared to modernize these systems thanks
to investments in the centralized IT platform made through the IT
Modernization appropriation. By investing in and promoting DOL's
centralized IT platform, the Department has established common
foundational components that are being leveraged across the Department
to ensure scalability, reliability, innovative development and minimum
time to deployment. DOL's platform and standardized process to
consolidate disparate and outdated systems, enables data sharing and
component re-use--allowing DOL to be forward-focused and on the
forefront of innovation with capabilities such as data analytics, case
management, artificial intelligence and machine learning, and Robotic
Process Automation. In addition to access to this standardized process
and best practices, agencies have access to optimized infrastructure in
a hyper-converged, hybrid-cloud data center environment and
technologies that facilitate design of an overall improved user
experience to allow employees to focus on mission work instead of
technology. The cloud-based platform has helped achieve DOL-wide
operational efficiencies in support of mission-driven IT applications
resulting in consolidated resources, eliminated redundancies,
accelerated modernization, and enhanced security.
While DOL has made significant progress in investing in the IT
platform, there is still an extensive list of legacy systems requiring
modernization overhauls. By applying a set of common criteria, DOL
prioritized legacy systems for modernization. DOL has been working to
address the top 50 systems and is making progress in this multi-year
effort. Based on DOL's FITARA's score, DOL has a proven track record of
making the right investment decisions to streamline technologies and
garner efficiencies for its IT, but budget limitations impede progress.
Consolidating, integrating, and updating DOL's legacy systems improves
DOL's security posture with capabilities such as standardized PIV-based
application access, multi-factor authentication, Continuous Diagnostics
& Mitigation (CDM) for cyber incident detection and response, and real-
time vulnerability and threat monitoring. Investing in information
technology provides significant public-impacting benefits in many
policy areas, including mine safety, visa processing, grants
management, and retirement benefits assurance, among many others. This
authority will enable DOL to modernize systems to ease public access to
DOL services, improve accessibility for users with disabilities,
mitigate security issues due to legacy technologies, and reduce the
increasing costs of supporting incompatible and obsolete technologies.
Each effort will improve reliability and accessibility for the public
to the Department's programs for employment, worker safety and health,
and benefits.
The investments that can benefit by the increased budget authority
include (but are not limited to):
--OLMS--Electronic Labor Organization Reporting System (e.LORS)
Investment: OCIO has identified e.LORS as one of the highest
priority systems in the Department for modernization due to
inherent risks associated with this outdated legacy technology
which has no vendor support nor is it supportable by DOL's
cloud-based enterprise platform infrastructure. Modernization
is projected to provide initial annual cost savings of
approximately $600,000 the year following initial deployment.
After the system is fully deployed, OLMS expects to experience
a 15 percent savings in annual IT cost due to a reduction in
costs for maintenance of the new system versus the old.
--OSHA--Information Management System Investment: The data
modernization and Transparency Initiative will help with the
Agency's ability to store data, retrieve it in the most
applicable form for operational use, and provide it in the most
user-friendly format for the public. Internally, easier
accessibility, paired with standardized data output from the
OSHA systems, will result in more efficient searches and better
ability for staff to analyze the data to lead to swifter
decisionmaking. Improvements in data retrieval and analysis
could also provide OSHA staff with insight into the types of
violations they might find at a facility, or enable a
compliance assistance specialist to provide best practices to
abate hazards most likely to be found at the worksite. These
efficiencies will lead to improved performance and cost savings
will be realized in the higher utilization by OSHA data
stakeholders of standardized reports with reliable information.
--WHD--Wage Determination System Investment: Modernizing the agency's
technology infrastructure is critical to WHD's success and a
key factor in mitigating risk across the agency. With the
recent implementation of the Electronic Case File (ECF), WHD is
realizing the ways in which streamlined business processes and
more agile technology can revolutionize and bring value to the
agency's work. In doing so, WHD improves its abilities to be
good stewards of taxpayer money and to provide the best
possible service and results to those the agency is here to
serve. Cost savings will be achieved in the following areas:
(1) a shift to the cloud will minimize the need for WHD to pay
for expensive O&M resources, which will yield an estimated
savings of $3 million per year; (2) elimination of paper record
keeping costs associated with case files storage and
administration once ECF is fully rolled out, will yield an
estimated savings of $500,000 per year which equates to
1,557,000 pages transferred between offices and to record
centers per year; and (3) automated ingestion of data through
the new WDS customer portal will yield a reduced need for
contractor support on data entry and processing of paper
records and provide an estimated savings of $300,000 per year
in actual contract costs. This represents total costs impacts
of $4 million per year, which can be readily redirected towards
mission-critical enforcement staff and activities.
--OFCCP--Case Management System Investment: The Affirmative Action
Verification Initiative (AAVI) is modernization need that would
allow OFCCP to ingest and process its administrative data in a
more uniform digital format. It will also allow staff to
retrieve and store data in a central repository that will
improve operations and enforcement by driving efficiency and
increasing the number and depth of analytical assessments
performed by the scheduling, policy, and enforcement branches.
Once development is completed, the ongoing costs will be
operations & maintenance, and a fraction of the help desk
service. The total operating cost is anticipated to be reduced
by approximately 65 percent, assuming no further development
efforts.
Question. How will the Department assure that unobligated balances
for the WCF are only generated from unexpected balances rather than the
delay of spending on the original purpose of the Congressional
appropriation?
Answer. The Department has a robust program to ensure that
unobligated balances are only generated from unexpected balances. The
Office of the Chief Financial Officer meets regularly with agencies to
review budget execution data and, in coordination with the Performance
Management Center, tracks the percent of discretionary appropriations
canceled after the five-year period of obligation authority has
expired. The results are reported in the Congressional Budget
Justification. In fiscal year 2020, the Department targeted 1.9 percent
in canceled appropriations and outperformed this target with a
cancellation rate of only 1.6 percent.
learning agendas and evaluation plan
Question. The ``Foundations for Evidence-Based Policymaking Act of
2018'' includes key provisions related to developing a multi-year
learning agenda, evaluation plan, improving coordination of data
government at the Department, and improving accessibility of labor
data. The Department has indicated it plans to release an updated
learning agenda and Capacity Assessment for Research, Evaluation,
Statistics, and Analysis in February 2022.
Please describe stakeholder consultations that have occurred or
will occur during the development of these plans.
Answer. The Department has engaged with a wide range of
stakeholders external to DOL to understand evidence production, use,
and future needs. For example, given the critical role of the
Department in supporting the public workforce system across the
country, DOL targeted early engagement with the workforce development
field. From November 2020 to April 2021, the Department sponsored
unstructured group discussions and individual conversations with 104
individuals representing 53 organizations spanning the U.S. workforce
development system. The objectives of the meetings were to encourage
participants to discuss what research, information, or evidence would
be most useful to them to improve the services they provide, and to
identify future research topics related to employment programs and
services and the future of work.
In addition to this broad-based engagement, the Department convened
an 11-member panel of highly qualified experts in the workforce
development field, including representatives from workforce boards,
academics, nonprofit organizations that partner with or study the
workforce system, and labor unions. The panel provided DOL with
targeted input on high-priority research topics related to WIOA
programs and services that could build on the current evidence base,
fill key knowledge gaps, and could be potentially suitable for rigorous
evaluation. A summary of the findings from these engagements will be
available on the Department's Chief Evaluation Office website later
this year.
DOL has also sought input on our evidence-building agenda from
Congressional stakeholders. On July 29, 2021, DOL's Office of
Congressional and Intergovernmental Affairs sponsored a Congressional
outreach session, which included a high-level briefing on the
Department's strategic and evidence-building planning approach.
Further, it allowed Congressional aides from both appropriations and
authorizations committees to ask questions and to provide direct
comments and reactions on the Department's activities.
Looking to the future, the Department will gain insights from
additional activities. For example, the responses to the equity RFI
issued by OMB on May 5, 2021 will be helpful to all Federal agencies,
including the Department, in evidence-building plans.\22\ Further, the
Department will engage in further targeted stakeholder feedback, to
support ongoing evidence development and dissemination activity. As
evidence building evolves to meet emerging needs, the Department
anticipates refining activities based on future stakeholder inputs. DOL
is especially interested in ensuring perspectives from a diverse array
of stakeholders who represent the communities our programs serve.
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\22\ The full text on the OMB RFI, Methods and Leading Practices
for Advancing Equity and Support for Underserved Communities Through
Government, can be found here: https://www.govinfo.gov/content/pkg/FR-
2021-05-05/pdf/2021-09109.pdf.
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Question. What has the Department learned from its prior
evaluations and how has the information been used in decisionmaking and
its programs, policies and operations? How will it inform future
decisions on programs, policies and operations?
Answer. The Department has learned a great deal from its
evaluations, data analytics efforts, surveys, and other rigorous
research projects to help improve our work on specific programs and
topics, and also to better understand how to best help specific
populations, especially populations facing barriers to full
participation and inclusion in the labor market. Specifically, the
Department has used the results from its evaluations and rigorous
research to expand and scale proven training strategies, to better
target enforcement and worker protection activities, to identify
underrepresented populations for tailored outreach, and even to improve
internal employee engagement, among other outcomes.
As decision-makers develop policies and programs to support workers
with job training and other employment supports, they have used the
results of evaluations to effectively target future investments. One
important example comes from evaluations of the Registered
Apprenticeships (RA) program. DOL funded a large-scale impact study of
RAs across 10 states, which was published in 2012. That study found
that RA participants had substantially higher short- and long-run
earnings than did non-participants and that the broader benefits of the
RA program for apprentices, government agencies, and society greatly
outweighed program costs. RA participants earned an average of $5,839
more than similar nonparticipants. Further, the completers of RA
programs earn over $300,000 more in salary and benefits during their
careers than similarly situated individuals who do not complete such
programs. This study is regularly cited by researchers, program
administrators, and policymakers as evidence for the return on
investment to RAs.
In part on the basis of those findings, both Congress and the
Department have pursued expansions of the RA program. In partnership
with the Department's Employment and Training Administration, the Chief
Evaluation Office is now actively evaluating these new investments in
the RA program, including studying efforts to expand apprenticeships to
underrepresented populations, as well as assessing the effectiveness of
expanding apprenticeships into high-growth and high-paying industries,
such as information technology.
Another important area of ongoing evidence-to-practice is related
to building the capacity of the nation's community colleges' education-
to-employment pipeline to meet 21st century demands. Based on the
results of a national evaluation of the DOL capacity-building grant
program, Trade Adjustment Assistance Community College and Career
Training (TAACCCT), the Department identified a range of promising
practices for future adoption including accelerated learning/career
pathways, persistence and completion strategies, and learning-based
connections to employment. The national evaluation generated these and
a wealth of other findings based primarily on a synthesis of 71
evaluation reports completed by grantees' third-party evaluators.
Evidence-based practices and insights from these studies' findings are
being applied to the Strengthening Community Colleges Training Grants
(SCCTG) Round 2 Funding Opportunity Announcement and future DOL
investments.
The Department has also helped states and local areas in their
efforts to build strong evaluation capacity, such as with the
Reemployment Services and Eligibility Assessment (RESEA) program.
Beyond funding and broadly disseminating findings from the largest
evaluation of the RESEA predecessor program, Reemployment and
Eligibility Assessment (REA) program, the Department has developed a
suite of resources to support states in implementing and leveraging
insights from the evidence base, as they build, pilot, and evaluate new
RESEA program components. The Department has provided evaluation
technical assistance resources, including webinars and other tools and
templates to help states understand, build, and use evidence.\23\
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\23\ The Department has developed a number of dedicated web-based
resources for states, including https://clear.dol.gov/reemployment-
services-and-eligibility-assessments-resea and https://
rc.workforcegps.org/resources/2016/10/03/06/29/RESEA.
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Other research efforts with notable impact on Departmental
operations include the Family and Medical Leave Act (FMLA) surveys of
workers and businesses. Fielded in 1995, 2000, 2012, and 2018, these
large-scale nationally representative surveys represent a primary
source of credible information about workers' leave needs, patterns of
usage, reasons for leave, awareness of leave benefits, among many other
factors. In addition, the size of the survey sample permits
disaggregation and analysis by geography and a variety of demographic
groups. The results of these surveys have helped the Department improve
and target educational campaigns on Federal leave worker protections,
as well as to provide technical assistance to businesses with
administration of this benefit as part of compliance and enforcement
efforts. The surveys have also been very important to Federal, state,
and local policymakers interested in understanding gaps in worker leave
needs and designing potential leave program proposals.
Question. What are the Department's plans for increasing the
investment in evaluation and evidence-building activities authorized by
the annual evaluation transfer provided in the Department of Labor
Appropriations Acts which significantly decreased from more than
$22,000,000 in fiscal year 2016 to $2,000,000 in fiscal year 2020?
Answer. The Department is committed to supporting a robust research
and evaluation portfolio, including the capacity to develop and deploy
evidence across agency management activities. Doing so is consistent
with this Administration's priorities, as reflected in the President's
Memorandum on Restoring Trust in Government through Scientific
Integrity and Evidence-Based Policymaking and through the Office of
Management and Budget's guidance to Federal agencies on the
implementation of the Evidence Act (OMB M-21-27). Bolstering the
Department of Labor's research and evaluation activities is reflected
in our fiscal year 2022-2026 strategic plan, which includes a
management goal to ``strengthen the Department's commitment and
capacity for evidence-based decisionmaking.''
______
Questions Submitted by Senator Jack Reed
wioa and public libraries
Question. Workforce Innovation and Opportunity Act and Public
Libraries.--Public libraries are critical but often under-resourced
partners in the workforce development system supported under the
Workforce Innovation and Opportunity Act. As the nation continues to
recover from the COVID-19 emergency, libraries will play a critical
role in helping people access benefits and get back to work.
What are the Department's plans to build and strengthen
partnerships between the one-stop system and public libraries and
ensure that public libraries have the resources necessary to provide
these workforce development services?
Answer. States have used WIOA funding for partnerships with public
libraries to conduct digital and financial literacy education
activities; educate library staff about available in-person and virtual
employment and workforce development resources; provide resume writing,
interview preparation, and other adult education programs; use the
libraries' space to provide career assistance and host job fairs; and
share workforce and labor market information. As an example,
California's Library Workforce Partnership Initiative (LWPI) recently
announced a funding opportunity for ten California public libraries to
partner with local Workforce Development Boards to build staff skills
and knowledge about workforce development and enhance workforce
development efforts in their communities. Local Boards in California
will work with public libraries, and together they will promote
employment, career development, and skill-building for job seekers.
The Department has partnered with the Institute of Museum and
Library Services (IMLS) for several years and continues to collaborate
with libraries since the passage of the Workforce Innovation and
Opportunity Act. This collaboration has included webinars to ensure
both libraries and the workforce development system know about the
assets and services they each have available to support jobseekers. The
Department published guidance to the workforce system reiterating the
importance of library partnerships and continues to make the workforce
system aware of the resources available in libraries to support
workforce development (See Training and Employment Notice 35-15,
``Encouraging Collaborations between the Workforce Investment System
and Public Libraries to Meet Career and Employment Needs'').
Other ongoing collaborative work with IMLS includes the Performance
Partnership Pilot (P3) authorized in 2014, in which pilot sites can
test innovative strategies to achieve significant improvements in
education, employment, and other key outcomes for disconnected youth.
P3 gives the Departments of Education, Labor, Health and Human Services
(HHS), and Justice (DOJ), the Corporation for National and Community
Service (CNCS), and IMLS authority to waive Federal statutory and
regulatory requirements that inhibit access to assistance and effective
service delivery for disconnected youth provided certain conditions and
requirements are met.
Public libraries play an integral role and are a crucial resource
in communities for job seekers. The Department will continue working
with libraries and promoting libraries as key partners in the workforce
system.
______
Questions Submitted by Senator Joe Manchin, III
black lung benefits
Question. Black lung is a terrible disease caused by inhaling coal
dust and mainly affects coal miners. After years of dedication to
providing our nation with energy, America's coal miners continue to
face the devastation of black lung disease. We are seeing more and more
cases of black lung--particularly in younger miners who have spent less
time working in the mines. Today, more than 25,000 coal miners and
their dependents rely on the Black Lung Disability Trust Fund to pay
for critical medical treatments and basic expenses. The Black Lung
Disability Trust Fund is financed primarily by an excise tax on coal
produced and sold domestically. In both 2019 and 2020, Congress passed
1 year extensions to ensure revenue streams for the Trust Fund did not
plummet. Current rates are set to expire on December 31, 2021, putting
an indebted Trust Fund in a precarious financial situation.
How can we ensure these benefits are protected and that our coal
miners continue to get the help they need?
Answer. President Biden has consistently expressed his
understanding of the harms to individuals and communities impacted by
black lung disease. He has also expressed his belief that coal mine
companies must be responsible for the occupational harms incurred by
their workers.
When the Government Accountability Office evaluated options for
improving the Trust Fund's financial condition in May 2018, it examined
different options and noted that permanently increasing the excise tax
on coal to at least $1.38 per ton for underground-mined coal and $0.69
for surface-mined coal (25 percent higher than the current rates),
could keep the Trust Fund solvent through 2050. The Administration is
committed to ensuring coal miners continue to receive their benefits in
any case, and without a legal change, the Trust Fund will continue to
borrow from Treasury in order to finance the benefits. Without
increased funding, the GAO estimated that the Trust Fund will
accumulate $15 billion of debt by 2050. That debt would be shouldered
by taxpayers instead of the responsible coal mine companies. The
Administration is eager to work with Congress to protect these critical
benefits and ensure that the Black Lung Disability Trust Fund is
solvent.
silica dust rule
Question. The extraction, refining, and transportation of coal
generates significant amounts of coal dust, which contains silica.
While coal dust is hazardous to miners' health on its own, silica is
classed as a carcinogen and is substantially more dangerous. Excessive
exposure to silica has been linked to black lung, silicosis, and the
most lethal type of black lung, progressive massive fibrosis (PMF). The
U.S. Department of Labor's Office of Inspector General (OIG) produced
an audit report last year critical of the Mine Safety and Health
Administration's (MSHA) inadequate efforts to safeguard coal miners
from crystalline silica exposure. The Inspector General's report found
that MSHA needs to update its regulations to: (1) Lower the legal
exposure limit to silica, (2) Improve the ability of the agency to
issue citations and fines for excess exposure to silica, and (3)
Increase sampling protocols where were found to be too infrequent to
protect miners adequately. These findings are extremely troubling--
especially while we continue to grapple with the COVID-19 pandemic.
How far along is the agency in creating a silica dust standard for
underground coal mines?
Answer. The Notice of Proposed Rulemaking for MSHA's Respirable
Crystalline Silica standard is scheduled for January 2022. MSHA is in
the process of developing the proposed rule including the preamble and
supporting documentation. Under Section 101 (a) of the Federal Mine and
Safety and Health Act of 1977, the proposal must go through the notice
and comment process, which includes solicitation of comments from
stakeholders. This allows the public opportunity to submit both written
comments and to present testimony at public hearings, if requested. The
substance of the final rule would take into consideration the comments
and testimony received during the rulemaking process.
Question. When do you anticipate releasing a new rule?
Answer. The Notice of Proposed Rulemaking for MSHA's Respirable
Crystalline Silica standard is scheduled for January 2022.
miners and covid-19 protections
Question. In March 2021, the Mine Safety and Health Administration
issued Federal guidance for mine operators, but fell short of issuing
an enforceable standard that would apply to mines and miners. Last
month, the Occupational Safety and Health Administration issued an
Emergency Temporary Standard for healthcare workers, which set
requirements to protect workers from contracting COVID-19 in healthcare
settings. I introduced a bipartisan bill in February, the COVID-19 Mine
Worker Protection Act, which would require you as the Secretary of
Labor to issue an Emergency Temporary Standard to requires mine
operators to protect their workers from COVID-19. This would include
development and implementation of a comprehensive infectious disease
exposure control plan, provide PPE to miners, and a framework for
documenting data. Mining is a dangerous business, we in West Virginia
know this all too well. But we should take all appropriate steps to
ensure miners are protected against COVID-19, something we know is
continuing to spread in our country.
Secretary Walsh, can you provide an update on what are you doing to
protect miners from COVID-19 exposure in and around mining sites?
Answer. On March 10, 2021, the Mine Safety and Health
Administration issued worker safety guidance to help mine operators and
mine workers implement a coronavirus protection program and better
identify risks that could lead to exposure. ``Protecting Miners: MSHA
Guidance on Mitigating and Preventing the Spread of COVID-19'' provides
updated guidance and recommendations, and outlines existing safety and
health standards. The guidance details key measures for limiting the
coronavirus's spread, including ensuring infected or potentially
infected miners are not in the workplace, implementing and following
physical distancing protocols and using surgical masks or cloth face
coverings. It also provides guidance on use of personal protective
equipment, improving ventilation, good hygiene and routine cleaning.
MSHA announced the guidance to more than 450 stakeholders during a
quarterly meeting and answered questions from the mining community.
Question. Will you work with me on this proposal to protect miners
from COVID-19 exposure?
Answer. We need to take all appropriate steps to ensure miners are
protected from COVID-19. The state of the pandemic is in constant flux
and MSHA will follow the science. If it becomes necessary, we will
issue an Emergency Temporary Standard for COVID-19 for the mining
industry.
addiction and returning to work
Question. As the opioid epidemic continues to take its toll, there
are more and more men and women who face severely limited job
opportunities after serving their time for crimes committed as a result
of addiction. To help fix this problem, I reintroduced a bill called
the Clean Start Act that seeks to help former addicts with criminal
records seal those records if they complete a comprehensive addiction
treatment program and show that they have turned their lives around.
West Virginia has now enacted its own version of the Clean Start Act.
What are some of the key ways the Department of Labor can help in
getting those struggling with addiction to get back to work?
Answer. The public workforce system complements health, law
enforcement, and social service agencies to address the impact of
opioid addiction and other substance use disorders. Since 2018, the
Department has issued three grant opportunities addressing the
workforce impacts of opioid addiction and other substance use
disorders. Under these programs, grantees provide reemployment services
for individuals impacted by the crisis; train individuals to transition
into professions that can impact the crisis, such as alternative pain
management, mental health treatment, and addiction treatment; and
create temporary employment opportunities for peer recovery counselors
and other positions that have a direct impact on the crisis. States and
eligible applicants can continue to apply for National Health Emergency
(NHE) Dislocated Worker Grants (DWGs) at www.grants.gov. ETA encourages
State Workforce Agencies, local Workforce Development Boards, outlying
areas, and tribal organizations to develop comprehensive partnerships
to creatively align and deliver career, training, and supportive
services that will best serve workers impacted by substance use
disorders and opioid addiction. The services that the public workforce
system offers complement evidence-based treatment for substance use
disorders.
DWG grantees use two main approaches to strengthen enrollment and
services for individuals with substance use disorders: bringing
individuals into the American Job Center for tailored services, and
bringing American Job Center services to providers of behavioral health
services. DWG grantees have also reported that courts and justice-
related agencies are strong partners. These may include juvenile and
family courts, drug courts, as well as prison and probation offices.
The workforce system can connect individuals who have been involved in
the juvenile and/or adult justice system to Reentry Employment
Opportunities grant programs (where available) to receive services and
resources. These partnerships help to bridge the gap between recovery
services and employment and self-sufficiency.
For further information, ETA issued Training and Employment Notice
2-21, Serving Individuals and Communities Impacted by Opioid Addiction
and Other Substance Use Disorders, July 23, 2021. This is in addition
to a series of virtual programs in 2021 to train professionals in the
workforce system on serving individuals impacted by substance use
disorder.
Question. What programs and initiatives, in your experience, will
be most effective in assisting former offenders rejoin the workforce?
Answer. The Department's Reentry Employment Opportunities (REO)
program, which includes current reentry grants Reentry Projects,
Pathway Home, and Young Adult Reentry Partnerships, align with
evidence-based practices that result in people involved in the justice
system getting employment. Our grant programs include flexibility to
support the individualized needs of participants. Supportive services
such as transportation, housing, mental health and substance abuse
counseling, and assistance with gaining identification necessary for
employment are crucial to initial and long-term stable employment for
this population. Without these basic supports, it is hard for
participants to succeed in training that leads to better employment
outcomes. People connected to the justice system also need mentors,
especially mentors with similar lived experiences, who can support them
through the transition from incarceration to reenter the community. The
use of Work Opportunity Tax Credits and the Federal Bonding Program can
also increase employers' hiring of previously incarcerated individuals.
Moreover, connecting participants to work that is legally available
to them after release is imperative. Sometimes local or state licensure
laws present barriers to employment. The Department is currently
developing a tool that will help individuals re-entering their
communities learn how license/certification laws align with their
employment goals. The tool will be available on https://
www.careeronestop.org/.
The Department has used existing evidence to support current
initiatives, building off the Linking Employment Activities Pre-Release
(LEAP) implementation study to develop the 2020 and 2021 Pathway Home
grants. The LEAP pilots provided pre-release services through jail-
based American Job Centers and linked participants to post-release
services. The study documented effective approaches to serving
individuals in jails. The Pathway Home grants further test the
identified concepts and link participants in jails and prisons to the
workforce system while still incarcerated. Additionally, the
participants maintain the same case manager pre- and post-release for
seamless reentry into the community. Federal Bonding is also an
important tool to help justice-involved individuals overcome existing
prejudice and stigma that may prevent potential employers from hiring
them due to perceived risks.
The Reentry Projects and Pathway Home initiatives are currently
being rigorously evaluated, which will further support the evidence
base for connecting people involved with the justice system to gainful
employment. Learnings from these projects will inform future grant
models for continuous improvement and refinement of reentry employment
projects.
unemployment insurance and returning to work
Question. Mr. Secretary, it's no question that the COVID-19
pandemic has had a tremendous impact on our country since the start of
2020. Among many actions that were taken to respond to its effects, I
was proud to work with my colleagues here in Congress to provide
Americans with unprecedented relief in the form of unemployment
insurance benefit programs, which has been a needed source of income
for many West Virginians and Americans during these trying times.
However, we are noticing that in some states and localities, despite
our economy steadily returning to full, pre-pandemic capacity,
unemployment rates still remain high. This trend is, of course,
concerning, especially given the fact that the U.S. economy is adding
jobs at rates seen before the COVID-19 pandemic set in. My
understanding is that this combination of still elevated unemployment
and elevated job growth has led many states, including my state of West
Virginia, to end the pandemic unemployment assistance program before
its expiration on September 4, 2021. Like many of my colleagues, I want
to ensure that folks in my state and our country can return to work and
can do so safely. I remain willing to work with anyone and through any
means to do so.
Do you believe that the enhanced unemployment insurance programs
Congress has implemented have contributed to the inability of some
employers to fill employment vacancies?
Answer. I am not aware of evidence that enhanced unemployment
insurance programs have contributed to the inability of some employers
to fill employment vacancies. The President has said: ``I think people
who claim Americans won't work, even if they find a good and fair
opportunity, underestimate the American people. So we'll insist that
the law is followed with respect to benefits. But we're not going to
turn our backs on our fellow Americans.'' And I agree.
Question. What can we do in Congress to support the economy and our
returning workforce as we return to pre-pandemic output levels and
activity?
Answer. The COVID-19 pandemic created widespread economic
disruption and further highlighted pre-existing deficiencies in the
availability of opportunities for all Americans to find good-paying,
safe employment. While existing WIOA funding amounts to states are set
by a statutory formula, the fiscal year 2022 Budget reflects the
Department's continued commitment to help American workers and job
seekers, particularly those from disadvantaged communities, get back on
their feet, access job training, and find pathways to high-quality jobs
that can support a middle-class life. The fiscal year 2022 Budget
requests $3.7 billion for WIOA programs, a $203 million increase over
the fiscal year 2021 funding. The Budget includes increases of
approximately $37 million for the Adult Program, $94 million for the
Dislocated Worker Formula Program, $100 million for Dislocated Worker
Grants (DWG), and $43 million for the Youth Program. This request will
make employment services and training available to more dislocated
workers, low-income adults, and disadvantaged youth who have been hurt
by the economic impacts of the COVID-19 pandemic.
The fiscal year 2022 Budget also includes the American Jobs Plan,
an investment that will create millions of high-quality jobs and
rebuild our country's infrastructure. This includes investments in
American workers--providing people with the skills they need to
succeed, strengthening the pathways to success, and ensuring that the
jobs that are created are high quality. Structural racism and
persistent economic inequities have undermined opportunity for millions
of workers, and these investments will prioritize underserved
communities and communities negatively impacted by the transforming
economy. The United States currently spends just one-fifth of the
average that other advanced economies spend on workforce and labor
market programs.
The Department included legislative proposals to implement the
American Jobs Plan, totaling $81.5 billion over 10 years, to address
these multiple challenges. This investment in proven workforce
development models includes:
--Creating and expanding sector-based training programs;
--Providing comprehensive support for dislocated workers to enable
their participation in high-quality training programs;
--Expanding Registered Apprenticeship and pre-apprenticeship
opportunities;
--Building community colleges' capacity to deliver high-quality job
training programs;
--Expanding access to evidence-based intensive, staff-assisted career
services;
--Providing subsidized jobs to workers with barriers to employment;
--Expanding workforce development services for justice-involved
individuals; and
--Phasing out the subminimum wage provided to workers with
disabilities while expanding their access to competitive,
integrated employment opportunities.
The Administration also has requested $100 million in the next
fiscal year to enable states to overcome the loss of legacy industries
or persistent employment challenges and work towards a clean energy
economy, helping to ensure steady employment opportunities into the
future.
Question. Are there any lessons to be learned with how our
unemployment systems have responded over the last year to better
prepare them if faced with another economic crisis in the future?
Answer. The Unemployment Insurance system has served as a critical
lifeline over the last year, helping nearly 53 million workers stay
afloat during the pandemic and the resulting economic crisis infusing
over $800 billion into the economy--staving off an even deeper
recession. At the same time, this crisis only further exposed
longstanding challenges in the UI program. While states mobilized
quickly to implement new crucial pandemic unemployment programs, they
were hamstrung by outdated technology and a lack of resources that made
them vulnerable to fraud from international crime rings. State
administrative funding was at a historic low. Recent policy changes in
state law are designed to make it more difficult to access UI. These
challenges made it difficult for states to quickly and equitably
deliver benefits to unemployed workers. Even as economic conditions
continue to improve, states face significant backlogs that have delayed
benefits to workers, and they have struggled to address fraud
perpetrated by sophisticated crime rings that persist in using new
techniques to attack UI systems.
The Department welcomes the $2 billion that Congress provided in
the American Rescue Plan Act and agrees that UI technology and
infrastructure modernization are urgently needed. State systems must
operate on a high-quality technology infrastructure that enables them
to administer their UI programs equitably and efficiently, so all
eligible unemployed workers have timely and meaningful access to this
vital benefit. The Administration is fully engaged in developing
detailed plans to achieve the goals and purposes set in the American
Rescue Plan Act and will keep Congress informed of those plans and
progress on the implementation of this important project.
The Department has engaged with states on this topic. The
Department conducted an initial webinar with state UI agencies on June
22, 2021, to share some of the current plans and approach on pursuing
UI information technology modernization. The webinar also solicited
states for engagement and partnership in these activities. Since then,
seven states have begun working with the U.S. Department of Labor (DOL)
and the U.S. Digital Service in research partnerships designed to help
fill in research gaps and provide input on the current and future
stages of UI modernization. Also, there have been follow-up virtual
office hours offered to states for further conversations on this topic.
All states should benefit from the funding provided in the American
Rescue Plan Act. As a state modernizes its IT system, there may be
opportunities to take advantage of the central, modular, open
technology solutions developed through this DOL/state partnership. DOL
is also deploying teams of experts, initially to six states, on a
voluntary basis to help identify process improvements that can speed
benefit delivery, address equity, and fight fraud (i.e., Tiger Teams).
The Tiger Teams can provide support, including funding, as states like
West Virginia look at business processes through a fraud-fighting and
equity lens in the course of modernization. Additionally, DOL is making
grants to states available to promote equity and fight fraud. These
grants will be designed to help states improve worker access to the UI
system, while helping states make system improvements that will
safeguard them against fraud.
______
Questions Submitted by Senator Roy Blunt
apprenticeships and nontraditional industries
Question. As Chairman of the Subcommittee in fiscal year 2016, I
began funding for the Apprenticeship program. I note that while the
Administration is requesting an increase of $100 million for the
program, the Department is no longer pursuing Industry Recognized
Apprenticeship Programs (IRAPs)--which would allow third-party entities
to apply for awards without being registered by the Department of
Labor. The previous Administration argued that IRAPs are intended to
supplement the current system, not replace or weaken it. IRAPs would
also allow non-traditional apprenticeship programs to thrive alongside
of the more traditional apprenticeships.
During a period when our nation is recovering from the
unprecedented strain of COVID-19 on our workforce, it is paramount that
we provide the most opportunities to get our country back to work.
How will you work with non-traditional industries to bring them
into the Apprenticeship program?
Answer. The Department supports industry-driven and employer-led
innovation in the Registered Apprenticeship System, a key strategy to
increase the representation of non-traditional industries in Registered
Apprenticeship. In fact, expanding Registered Apprenticeship into non-
traditional industries has been a Departmental priority for the past 10
years, and we've seen incredible growth due to numerous investments and
promotional activities. Since 2015, the number of Registered
Apprenticeships in non-traditional industries (non-construction) has
grown by over 43 percent.\24\
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\24\ https://www.dol.gov/agencies/eta/apprenticeship/about/
statistics/2020.
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Industry designs and operates Registered Apprenticeship programs.
The Department works in partnership with industry to provide technical
assistance to support and ensure programs meet minimum quality
standards for apprentice safety, welfare, and equal opportunity. This
approach ensures that Registered Apprenticeship programs are employer-
led, industry-driven, of high quality, responsive to the changing needs
of employers, and capable of producing highly skilled workers that can
compete in a highly-competitive global economy.
Over the past 6 years, the Department has made significant
investments to support apprenticeship and work-based learning in non-
traditional industries. Investments include recent awards to support
state-led expansion, equity and innovation grants, innovative
approaches to developing consistent standards in non-traditional
occupations through competency-based occupational frameworks, as well
as the establishment of new Registered Apprenticeship (RA) Technical
Assistance (TA) Centers of Excellence. This includes a dedicated RA TA
Center to support the development of Registered Apprenticeship Program
frameworks (competency-based, hybrid, and other innovative models),
national standards including those that include industry-recognized
credentials, and supporting industry in meeting Registered
Apprenticeship Program design and development requirements in
compliance with 29 C.F.R. Part 29, Subpart A.
The Department has also supported employer-led innovation in
Registered Apprenticeship through the following mechanisms:
--Industry Intermediaries: Since 2016, DOL has funded industry
associations, also referred to as ``industry intermediaries''
to develop National Apprenticeship Programs to meet critical
industry needs and lead the expansion of Registered
Apprenticeship across a wide range of industries. The most
recent round of industry intermediary awards included a focus
on expanding registered apprenticeship into non-traditional
industries.
--Growth of National Programs: To better support national employers
and industry-led efforts, the Department has enabled
significant growth in the number of organizations that have
registered as National Apprenticeship Programs. This growth has
nearly doubled over the past several years. Between January
2019 and May 2021, the Department registered approximately 70
National Apprenticeship Programs. These National Apprenticeship
Programs allow employers to quickly and easily adopt industry
vetted and Departmental-approved Registered Apprenticeship
programs into their organization through a simple employer
acceptance agreement, reducing paperwork and program
duplication.
Question. What resources are needed to ensure that all
opportunities for apprenticeships are considered at the Department?
Answer. Dedicated resources for Registered Apprenticeship are
critical to expand the program. I urge Congress to enact the
President's Budget and the American Jobs Plan. Within the fiscal year
2022 President's Budget, the Administration proposes increasing
apprenticeship funding by $100 million, for a total of $285 million.
The Department will prioritize investments that expand the
apprenticeship model to new sectors and occupations and increase access
for historically underrepresented groups, including people of color,
women, individuals with disabilities, and justice-involved individuals.
The American Jobs Plan provides another opportunity for Congress to
ensure support for apprenticeship. The Administration proposes
investing $10 billion over 10 years to create between one and two
million new Registered Apprenticeship slots.
green jobs
Question. The budget request includes an increase of $100 million
within the Dislocated Worker National Reserve for a new initiative that
will target investments for training and employment opportunities in
communities for new industries, including those supporting ''green
jobs''.
Additionally, the budget request includes an increase of $20
million for a new competitive grant program to prepare eligible
veterans, transitioning service members, and their spouses for careers
in ``green jobs.'' This new competitive grant program is proposed to be
housed within Training and Employment Services, as opposed to within
the Veterans' Employment and Training Service program.
I'm concerned with the notion that the Federal Government is
dictating the future of our workforce by tying training dollars to
``green jobs.'' Specifically, the new Power initiative will impose
significant restrictions on local economies to focus only on green
jobs, and not necessarily jobs their local economy may need. The
Department already spends millions of dollars to train workers for jobs
that are needed in local communities because of the partnership with
state and local workforce boards. Therefore, why is the Federal
Government simultaneously determining what industries can prosper in
local economies through this new initiative?
Answer. The $100,000,000 requested is part of a new Interagency
Working Group on Coal and Power Plant Communities and Economic
Revitalization. The Working Group is not an attempt by the Federal
Government to determine which industries can prosper. Rather, it is an
initiative that will complement other targeted Federal investments to
assist workers and transform local economies in communities
transitioning into new, sustainable industries, including those
supporting new or sustainable energy sources. This targeted program
will help energy industry workers who have been adversely impacted by
changes in the economy prepare for jobs in demand in states and local
communities that choose to apply. The initiative will build on the
success of the original POWER initiative and expand beyond the coal
industry. It will address changes in the energy economy, and other
legacy industries, through strategic planning, partnership development,
and reskilling and reemployment activities aligned with longer-term
economic transformation efforts. It will support community-led
workforce transition, layoff aversion, job creation, and other
strategic initiatives designed to ensure economic prosperity for
workers and job seekers in the coal, oil, gas, and other industries in
decline.
Question. I'm encouraged to see an increase for veterans' programs
in the budget request. Many service members leave the military with
significant training that can translate to the civilian workforce, and
it should be a priority to ensure that our veterans have the resources
necessary to transition to civilian life. Our workforce system should
be flexible to allow these workers to succeed. However, I'm concerned
about the proposal for a new, $20 million program to train our nation's
heroes for ``clean energy'' jobs, only. I do not think we should tie
our training dollars to specific jobs, especially jobs for our
veterans, nor should the Federal Government be in the position to pick
winners and losers in the economy. Why does the Department think that
it can better dictate workforce opportunities for our transitioning
service men and women, as opposed to our local economies and the local
job creators that truly understand the workforce needs of our
communities?
Answer. The Veterans' Clean Energy Training Program will be a new
competitive grant program to prepare eligible veterans, Transitioning
Service Members (TSMs), and their spouses for careers in the clean
energy sectors of the energy industry. This program does not dictate
workforce opportunities but, instead, allows states and local
communities, based on their local workforce needs and in partnership
with local businesses, to help veterans prepare for jobs that are in
demand. Clean energy job opportunities are expected to grow between now
and 2029. Certain occupations are expected to grow rapidly in the next
several years or have large numbers of job openings. A skilled
workforce is foundational to achieving the President's goal of having
100 percent carbon-free electricity by 2035 while creating a more
resilient energy grid, lowering energy bills for middle-class
Americans, and improving air quality and public health outcomes. The
Department's Employment and Training Administration will develop and
implement the program collaboratively with the Department's Veterans'
Employment and Training Service and the Department of Veterans Affairs
to identify appropriate state, Federal, and industry partners to
deliver the education, training, and job placement of program
participants.
Grantees will use effective outreach, media, and engagement to
recruit a diverse cohort of participants for job training. Grantees
will use robust, comprehensive work-based learning strategies, such as
On-the-Job Training, customized training, Incumbent Worker Training,
Registered Apprenticeship, pre-apprenticeship programs that matriculate
to Registered Apprenticeship programs and paid work and internships.
Other allowable approaches will include classroom, including
competency-based, and technology-based training strategies, culminating
in the attainment of an appropriate industry-recognized certificate or
credential.
Grantees will also provide technical assistance to this network of
employers to successfully employ and retain veterans, TSMs, and
military spouses. In addition, grantees will provide participants with
supportive services, such as transportation and childcare, to enable
them to participate in activities authorized under the program.
The program will engage a wide array of employers, large and small,
including Veteran-Owned Small Businesses and Service Disabled Veteran
Owned Small Businesses in the adoption and deployment of training and
work-based learning. These will be public-private partnerships engaging
employers across clean energy sectors, which will help empower local
communities and ensure that we are training workers for occupations
that are in demand.
The program will develop new or expand existing successful industry
sector partnerships and build off of lessons learned from the
Department of Energy's Solar Ready Vets program. These partnerships of
multiple employers, educational institutions, economic development
agencies, workforce development entities, and community-based
organizations will identify and collaboratively meet the workforce
needs of the growing clean energy sector within a given labor market,
incorporating career pathway strategies by aligning education and
training programs with industry needs.
joint employer rule
Question. In June 2021, DOL sent its proposed rescission of the
previous Administration's Joint Employer rule to the Office of
Information and Regulatory Affairs for final rule. I am concerned that
the Department is moving to rescind the previous Administration's Joint
Employer rule and potentially issue another new rule. This
Administration's steps will further burden small and local businesses,
who are the economic drivers of our economy. As our nation recovers
from COVID-19, we need to be encouraging job growth and job creation,
not stifling it with further regulations and complicated, ambiguous
standards.
What are the Department's substantive plans and timeframe with
respect to this rulemaking?
Answer. The Department issued a final rule rescinding the previous
Administration's Joint Employer rule on July 30, 2021. The rescission
will be effective October 5, 2021.
covid-19 emergency temporary standard
Question. The Occupational Safety and Health Administration (OSHA)
published an emergency temporary standard (ETS) relating to COVID-19
protections in the workplace. The requirements of the ETS apply to
``all settings where any employee provides healthcare services or
healthcare support services.'' I am concerned that there's ambiguity
regarding who and what are exempt from the emergency rule. While retail
pharmacies have a blanket exemption, walk-in medical clinics, doctor's
offices, dental practices, and other ``non-hospital ambulatory care
settings'' may qualify for exemptions depending on their screening
policies and the type of care performed. To qualify for an exemption,
the employer must limit the number of entrances to a facility and have
a screening process where people are checked at the entrance or outside
of the facility. ``Screening'' is defined as ``asking questions to
determine whether a person is COVID-19 positive or has symptoms of
COVID-19.'' Testing is optional.
Workplaces and employers that are not exempt from this emergency
rule must develop and implement a COVID-19 plan; provide and ensure the
wear of facemasks for employees; provide respirators and other Personal
Protective Equipment to employees; ensure social distancing when
possible; install physical barriers where social distancing cannot take
place; and clean and disinfect all workplace areas in accordance with
CDC guidelines.
While I appreciate that hospitals and nursing homes must comply
with the provisions of this emergency temporary standard, as those are
the settings in which there's an increased risk of coming into contact
with an infected person, I am worried that there's too much ambiguity
as to who and what are exempt outside of those facilities. Further, the
provisions of this emergency standard place a burden on the employer,
and I'm concerned that certain workplaces that could be exempt from
these provisions may not realize it. Can you detail what settings are
exempt from this standard, and will these settings be subject to an
OSHA inspection?
Answer. The COVID-19 ETS applies to employers in settings where any
employee provides healthcare services or healthcare support services.
This includes: Employees in hospitals, nursing homes and assisted
living facilities; emergency responders; home healthcare workers; and
employees in ambulatory care facilities. The focus of the ETS is on
protecting healthcare workers in settings where suspected or confirmed
COVID-19 patients are treated. Thus, the standard targets healthcare
settings where OSHA has found the elevated risk associated with care of
persons with confirmed and suspected COVID-19, and associated
activities, constitute a grave danger. Accordingly, it exempts out
settings where this elevated risk does not exist.
Paragraph (a)(2) of the standard serves to limit the applicability
of the ETS and provides that the ETS does not apply to the following:
(i) The provision of first aid by an employee who is not a licensed
healthcare provider; (ii) the dispensing of prescriptions by
pharmacists in retail settings; (iii) non-hospital ambulatory care
settings where all non-employees are screened prior to entry and people
with suspected or confirmed COVID-19 are not permitted to enter those
settings; (iv) well-defined hospital ambulatory care settings where all
employees are fully vaccinated and all non-employees are screened prior
to entry and people with suspected or confirmed COVID-19 are not
permitted to enter those settings; (v) home healthcare settings where
all employees are fully vaccinated and all non-employees are screened
prior to entry and people with suspected or confirmed COVID-19 are not
present; (vi) healthcare support services not performed in a healthcare
setting (e.g., off-site laundry, off-site medical billing); or (vii)
telehealth services performed outside of a setting where direct patient
care occurs.
The agency has developed numerous compliance assistance materials
to help employers understand and apply the ETS to their workplace.
These materials can be found at the OSHA website.\25\ In particular,
the agency has developed a flow chart to help employers determine
whether and how their workplace is covered by the COVID-19 Healthcare
ETS. The flow chart is available on the website.\26\ The agency has
also provided responses to many Frequently Asked Questions (FAQs),
several of which address scope issues.\27\
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\25\ https://www.osha.gov/coronavirus/ets.
\26\ https://www.osha.gov/sites/default/files/publications/
OSHA4125.pdf.
\27\ https://www.osha.gov/coronavirus/ets/faqs.
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Employers that are covered by the ETS can consult the Inspection
Procedures for the COVID-19 Emergency Temporary Standard \28\
compliance directive for information about inspection procedures and
enforcement policies for the ETS. It should be noted that upon opening
a COVID-19 related inspection where the ETS could potentially apply,
the agency's enforcement personnel are specifically directed to
determine if any of the exemptions outlined in sections 29 CFR
Sec. 1910.502(a) apply to the whole facility or to well-defined
portions to ensure that the ETS is not inappropriately applied to an
employer who may be exempt.
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\28\ https://www.osha.gov/sites/default/files/enforcement/
directives/DIR_2021-02_CPL_02.pdf.
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Employers not covered by the ETS can consult the Updated Interim
Enforcement Response Plan for Coronavirus Disease 2019 (COVID-19) \29\
for more information about how OSHA is handling COVID-19-related
complaints, referrals, and severe illness reports in these workplaces.
All employers can also consult the Revised National Emphasis Program--
Coronavirus Disease 2019 (COVID-19) \30\ for more information about how
OSHA is targeting specific high-hazard industries or activities where
COVID-19 hazards are present in its enforcement activities.
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\29\ https://www.osha.gov/laws-regs/standardinterpretations/2021-
07-07.
\30\ https://www.osha.gov/sites/default/files/enforcement/
directives/DIR_2021-03_CPL_03.pdf.
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restoration of dol staffing
Question. The fiscal year 2022 budget request includes an increase
of $1.7 billion over the fiscal year 2021 level for the Department.
Included in that increase is an increase of an additional 1,949 full-
time equivalents (FTE) for the Department, increasing total FTE levels
from 14,906 to 16,855. The vast majority of the increases are within
Worker Protection components, which will ultimately increase the number
of enforcement actions against businesses.
The budget includes an additional 1,949 full-time equivalents for
the Department. 362 of those are for OSHA alone, increasing the number
of employees by over 13 percent. Most of those personnel won't focus on
training individuals to renter the workforce, which is arguably the
most important part of the Department's mission, especially as we
recover from the unprecedented strain on our economy from COVID-19. Why
is the Department not prioritizing training programs over increasing
Federal bureaucracy?
Answer. In addition to a much-needed restoration of staffing levels
in Worker Protection activities, the fiscal year 2022 Budget renews
DOL's commitment to help American workers and job seekers, particularly
those from disadvantaged communities, get back on their feet, access
job training, and find pathways to high-quality jobs that can support a
middle-class life. Significant investments in training include:
--Apprenticeship: The Budget requests $285 million, a $100 million
increase above the fiscal year 2021 enacted level, to expand
Registered Apprenticeship (RA) opportunities while increasing
access for historically underrepresented groups, including
people of color and women, and diversifying the industry
sectors involved.
--Workforce Innovation and Opportunity Act State Grants: The fiscal
year 2022 Budget also requests $3.7 billion, a $203 million
increase over the fiscal year 2021 enacted level, for Workforce
Innovation and Opportunity Act State Grants. This request will
make employment services and training available to more
dislocated workers, low-income adults, and disadvantaged youth
hurt by the economic fallout from the pandemic.
--Training displaced coal workers: The Budget requests a $100 million
investment for DOL's role in the new multi-agency POWER+
Initiative, aimed at reskilling and reemploying displaced coal
workers in Appalachian communities. This request would
complement other targeted Federal investments in POWER+ to
assist workers and transform local economies in communities
transitioning away from fossil fuel production.
--Veterans: The VETS Budget prepares America's veterans, service
members, and their spouses for meaningful careers, provides
them with employment resources and expertise, protects their
employment rights, and promotes their employment opportunities.
The Budget provides funding for the Veterans' Employment and
Training Service's (VETS) core programs, which help improve
skills and provide employment opportunities for veterans across
the country. The request also provides the Employment and
Training Administration (ETA) $20 million for a new program,
developed in collaboration with VETS and the Department of
Veterans Affairs, focused on helping veterans shift to careers
in clean energy, which would help combat climate change while
preparing veterans for good-paying jobs.
cares act and american rescue plan spending
Question. The Department of Labor received $385 million in
discretionary and mandatory supplemental funds through the CARES Act
that was passed in March 2020 and more than $2.2 billion in mandatory
funds through the American Rescue Plan (reconciliation bill) that was
passed in March 2021.
As of June 30th, a little more than $270 million has been obligated
and only $91 million has been drawn-down from the $385 million provided
in CARES. Further, of the $2.2 billion provided in the American Rescue
Plan, less than $25 million has been obligated and only $5.6 million
has been drawn-down. What is the delay in spending this funding and how
long will it take you to expend these dollars?
Answer. The CARES Act appropriated to the Department with $345.0
million for National Dislocated Worker Grants (DWGs) and $15.0 million
for the Departmental Management account to prevent, prepare for, and
respond to coronavirus, including enforcing worker protection laws and
regulations. In addition, the CARES Act appropriated $25.0 million to
the Office of Inspector General (OIG) for oversight of the unemployment
provisions enacted in the CARES Act.
The Department issued guidance to States explaining how to apply
for Disaster Recovery DWGs and Economic Recovery DWGs. The Department
accepts applications on a rolling basis. Based on the anticipated large
volume of funding requests across the nation, the Department approved
reduced initial funding amounts to address the critical community needs
in areas hardest impacted by the COVID-19 public health emergency. The
amount initially provided was 33 percent of the grant amount requested
or a set initial award amount correlated to a severity rating. The
Department typically funds DWG awards on an incremental basis, although
on rare occasions, it may award funds in full or in larger-than-typical
increments, depending on factors such as the severity of the disaster
and the viability of a proposed project.
The Department has awarded nearly $398 million in Disaster Recovery
and Economic Recovery DWGs related to COVID-19. Of this total,
approximately $143 million was obligated from the Program Year 2019
appropriation; the remainder was obligated from the supplemental funds
appropriated under the CARES Act. ETA determines the amount to award
for subsequent funding opportunities on a recipient's justification for
the additional funds and continued demonstrated need, as evidenced by
productive performance, enrollments and expenditures. ETA has
traditionally considered requests for subsequent funding opportunities
when expenditures have reached approximately 70 percent of the total
DWG funds awarded to date. ETA works closely with states in determining
their needs and identifying when additional resources may be warranted.
Of the $15.0 million appropriated to the Departmental Management
account, $1.0 million was transferred to OIG, as required. OIG's funds
are available without fiscal year limitation. The remaining $14.0
million was allocated between the Occupational Safety and Health
Administration ($5.5 million); the Employment and Training
Administration's Program Administration account ($4.0 million); the
Wage and Hour Division ($2.5 million); the Employee Benefits Security
Administration ($1.0 million); and the Office of the Solicitor ($1.0
million). These funds are available for obligation until September 30,
2022.
As of July 31, 2021, the Department has obligated approximately
$11.0 million and $9.9 million has been expended. The Department will
obligate the remaining $4.0 million over the remainder of fiscal year
2021 and fiscal year 2022 and expend the funds shortly thereafter.
Of OIG's $25.0 million CARES Act appropriation, as of July 31,
2021, OIG has obligated approximately $9.5 million and expended
approximately $5.1 million. These funds are available for obligation
until expended. The OIG indicated that it has allocated its CARES Act
appropriation to support audits and investigations related to the
expansion of the UI program during the pandemic, to include the hiring
of more than 50 criminal investigators to combat unprecedented levels
of fraud in the program. The OIG's funding will cover activities,
salaries, and benefits through the end of fiscal year 2022.
The American Rescue Plan Act (ARPA) appropriated $2.0 billion to
detect and prevent fraud, promote equitable access, and ensure the
timely payment of benefits with respect to the unemployment
compensation program, $8.0 million to carry out Federal activities
related to the administration of unemployment compensation programs,
and $200.0 million to carry out COVID-19 related worker protection
activities.
The unemployment insurance (UI) system provided a critical lifeline
for millions of workers during the pandemic. The pandemic also exposed
longstanding challenges in the UI system. The funds appropriated under
ARPA are critical to helping states address the most acute challenges
they have faced this past year. The Department will be using the funds
to tackle these acute problems facing the system in the short-term
while also working to address long-term challenges. The Department is
currently focusing on four key areas: sending multidisciplinary teams
to states to provide intensive technical assistance; a comprehensive
approach to implementing identify verification; modernizing technology;
and directing grants to states to help solve some of these challenges
immediately. Regarding the worker protection funding, the Department
has set up a website \31\ that outlines the planned use of funds for
the worker protection activities and a quarterly status of obligations.
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\31\ https://www.dol.gov/general/american-rescue-plan/worker-
protection-supplemental-appropriation.
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unemployment insurance and consumer finance applications
Question. In your testimony, you stated that you have two key goals
for unemployment insurance: decreasing fraud and increasing access to
benefits. You mentioned that the Department will have a four-pronged
approach to bolstering unemployment insurance, including modernizing
technology.
What are your thoughts on utilizing consumer finance applications
to assist states in modernizing their unemployment insurance systems
and preventing fraud?
Answer. The pandemic has only underscored states' desperate need
for technological support and improvements. Many state systems are
operating on outdated technology, which made it difficult for them to
rapidly respond to changes in law and economic conditions. Part of our
plan for the $2 billion appropriated under the American Rescue Plan Act
is to address this problem by centrally developing open, modular
technology solutions that states may adopt as part of ongoing
modernization and improvement efforts. Shared IT solutions will be
designed to integrate with state systems and will focus on the needs
that are shared across states, while supporting states to implement and
continue operating state specific elements. DOL's vision is to provide
software to support end-to-end administration of UI, including benefit
delivery, employer tools, and appeals. As part of this effort, DOL will
consider all possible IT solutions that will assist states in
modernizing their systems and preventing fraud, including consumer
finance applications. DOL will work with the IT staff in the States to
develop and execute a plan that builds resilience in the UI systems
across the country.
______
Questions Submitted by Senator Shelley Moore Capito
funding for west virginia grantees
Question. The Employment and Training Administration, an agency
within your Department, is the leading agency responsible for providing
job training and workforce development. My home state of West Virginia
has one of the highest rates of unemployment in the nation, and yet we
receive a minimal amount of ETA grant funding to retrain workers in
emerging industries as we unfortunately shift away from a coal-
dominated economy.
Why is it that we are missing out on this funding and how will you
ensure that states like West Virginia, which have a clear need for
investment in our workforce development, are adequately supported?
Answer. The Employment and Training Administration (ETA) provides
grant awards to eligible entities to carry out a public purpose for the
direct benefit or use of the United States Government. Many of these
programs are funded through formula grants whereby the law specifies or
allows ETA to determine the formula to distribute funding to the
recipients. These grants include funding under Title I of the Workforce
Innovation and Opportunity Act (WIOA), Unemployment Insurance
Administrative Awards, Foreign Labor, Employment Service, and Trade
Adjustment Assistance grants to states and territories. The allocation
formula and funding allotments for these programs are published in ETA
guidance and are made available publicly.\32\
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\32\ https://wdr.doleta.gov/directives/all_advisories.cfm.
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In addition to formula-funded programs, some legislation provides
discretionary funding for the Department to improve operations,
performance, or knowledge. These competitive grants are typically
awarded to eligible entities to create or expand innovative workforce
development programs for workers and employers. The Department develops
grant competitions and formally issues Funding Opportunity
Announcements (FOAs) that convey the application requirements and
evaluation considerations. These FOAs are published on the Grants.gov
website and provide prospective applicants with the framework for
preparing a grant application. The Department will often host a webinar
or other event to discuss new FOAs for prospective applicants during
the open period. A Technical Review Panel, composed of Federal staff
and other workforce development experts, evaluates FOA applications.
Reviewers evaluate and score applications based solely upon the
evaluation criteria in the published FOA. The ranked application scores
serve as the primary basis for the Department's selection of funding
applications.
During fiscal year 2020, ETA awarded more than $83.33 million in
grant funding to West Virginia, including $78.67 million for formula
programs and an additional $4.66 million in discretionary grants. These
awards included two grants under the Workforce Opportunities for Rural
Communities (WORC) program that enables communities within the
Appalachian and Delta regions that have been hard-hit by economic
transition, with slow recovery, to develop local and regional workforce
development solutions that align with economic development strategies.
ETA anticipates making a third round of WORC awards this Fall.
Question. On that same note, I was disappointed to learn two
YouthBuild programs weren't selected for continued funding. I'd love to
learn more about why, this program has helped so many young adults get
back on track for a career.
Answer. The Department issues the YouthBuild Funding Opportunity
Announcement (FOA) each year. This FOA is a competition open to both
previously-funded applicants and entities that never received an award.
Since this is a competitive process, not all applicants are selected
for funding. Of the 130 applications reviewed this year, due to limited
funds available, only 68 were selected. All applicants are contacted
with the results of the competition and provided guidance on how to
receive evaluative feedback related to their application. This feedback
often helps applicants submit a more competitive application in the
future.
______
Questions Submitted by Senator Mike Braun
dol freedom of information act requests
Question. The Freedom of Information Act (FOIA), codified at 5
U.S.C. Sec. 552, provides public access to certain Federal agency
information.
Please provide the Committee with the Department of Labor's (DOL)
budget request specifically for continued administration of and
compliance with FOIA requests.
Answer. The DOL's FOIA processing is a decentralized operation such
that each of the Agency's components account for their own expected
FOIA processing costs within their individual budget requests. In the
Agency's last annual FOIA report, completed for fiscal year 2020, DOL
reported a total of 120.5 Equivalent Full-Time FOIA Employees and spent
$19,103,622 in FOIA related processing costs for the DOL's 23
decentralized FOIA components,
While DOL's President's Budget for fiscal year 2022 does not
include a specific request for the aggregate cost of FOIA processing
and administration, DOL is able to identify certain items included
within its budget request that relate specifically to FOIA processing
and administration. First, for fiscal year 2022, the DOL has projected
a cost of $1,170,000 for its Office of Information Services (OIS),
which supports the statutorily mandated functions of the Department's
Chief FOIA Officer (currently the Solicitor) in carrying out
Department-level responsibilities under the Freedom of Information Act.
5 U.S.C. Sec. 552. In addition, DOL's Office of the Chief Information
Officer (OCIO) has projected fiscal year 2022 FOIAXpress System cost to
be $1,121,576, to include $891,210 for FOIA System Costs (Licensing and
Hosting), $155,366 for FOIA.
Question. Pertaining to the January 1, 2021 to July 15, 2021
timeframe, please also provide:
1. An update on the volume of FOIA requests;
2. The average time the agency took to fulfill such and the
volume of FOIA requests outstanding; and
3. How many requests the agency has utilized a statutory
exemption to deny fulfillment of a FOIA request.
Answer.
1. An update on the volume of FOIA requests
------------------------------------------------------------------------
Total Number of Initial FOIA Requests Received............. 7,632
Total Number of Initial FOIA Requests Processed............ 8,442
------------------------------------------------------------------------
``Total Number of Initial FOIA Requests Processed'' includes requests
received prior toP January 1, 2021.
2. The average time the agency took to fulfill such and the
volume of FOIA requests outstanding:
------------------------------------------------------------------------
Average Number of Days to Process (Simple Queue)........... 45.8
Average Number of Days to Process (Complex Queue).......... 72.2
Average Number of Days to Process (Expedited Queue)........ 79.1
Total Number of Pending Requests (outstanding) request..... 2,296
Total Number of Backlogged Requests (20 workdays or older). 1,503
------------------------------------------------------------------------
``Simple Queue'' is based on low volume and/or simplicity of records
requested and ``Complex Queue'' is based on high volume and/or
complexity of records requested.
3. How many requests the agency has utilized a statutory
exemption to deny fulfillment of a FOIA request: 2
Question. Please also provide a comparison of such FOIA volume and
related fulfillment to calendar year 2020.
Answer.
1. An update on the volume of FOIA requests
------------------------------------------------------------------------
Total Number of Initial FOIA Requests Received............. 15,820
Total Number of Initial FOIA Requests Processed............ 15,645
------------------------------------------------------------------------
2. The average time the agency took to fulfill such and the
volume of FOIA requests outstanding:
------------------------------------------------------------------------
Average Number of Days to Process (Simple Queue)........... 39
Average Number of Days to Process (Complex Queue).......... 53.3
Average Number of Days to Process (Expedited Queue)........ 18.8
Total Number of Pending Requests (outstanding)............. 2,589
Total Number of Backlogged Requests (20 workdays or older). 1,714
------------------------------------------------------------------------
3. How many requests the agency has utilized a statutory
exemption to deny fulfillment of a FOIA request: 0
payroll audit independent determination program
Question. In the Trump Administration, the Department of Labor's
Wage and Hour Division (WHD) saw both record-breaking enforcement
numbers, and record-breaking outreach efforts. Despite these incredible
outcomes for workers, the Biden Administration ended a voluntary
compliance program called PAID (Payroll Audit Independent
Determination). Will you commit to reviewing and reestablishing the
PAID program?
Answer. The Department ended the Payroll Audit Independent
Determination (PAID) program in January 2021. Between 2018 and 2021,
approximately 70 employers participated in the PAID program. The
Department continues to provide outreach and education resources for
employers. Employers may continue to contact any of our 200 Wage and
Hour Division offices to confidentially discuss their compliance
questions, or to self-report violations they would like to resolve.
teleworking
Question. How many of DOL's approximately 15,279 Full Time
Equivalent (FTE) person workforce in Washington, D.C. is currently
teleworking either (1) part-time or (2) full-time?
Answer. Based on data from the end of July 2021, 99.1 percent of
DOL and PGBC employees are teleworking either on a part-time or full-
time basis.
Question. For part-time staff, what proportion of their time is
spent teleworking, on average?
Answer. Pre-pandemic, part-time employees spent 21 percent of their
time teleworking. During the maximum telework posture, part-time
employees spent 92 percent of their time teleworking.
Question. What has such teleworking done to decrease commuting and
parking reimbursements, energy consumption, and other expenditures
compared to years prior to the pandemic?
Answer. Transit subsidy costs have decreased and these funds have
been reinvested by agencies in their program activities. There have
been some savings in energy consumption related to the reduction in on-
premises staff. To comply with safety recommendations from the Centers
for Disease Control and Prevention in response to the COVID-19
pandemic, however, the Heating, Ventilation and Air Conditioning system
is now run 24 hours a day to increase ventilation in the building. This
has increased energy usage overall from prior years.
secretary's calendar
Question. Previous administrations posted the calendars of their
agency head for public inspection. As of July 23, 2021, there is no
calendar information available to the public to understand your daily
efforts on the public's behalf.
Will you commit to begin sharing your calendar information with the
public on the DOL website? Can you provide a date on which your
calendar detailing the first several months of your tenure will be
published publicly?
Answer. No later than September 29, 2021, Secretary Walsh's
calendar will be available at https://www.dol.gov/general/foia/
readroom.\33\ This will include the Secretary's calendar dating back to
March 23, 2021 through July 31, 2021. Moving forward the calendars will
be updated on a monthly basis.
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\33\ https://www.dol.gov/general/foia/readroom.
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unemployment insurance and third-party income verification
Question. Pandemic Unemployment Assistance (PUA) has brought
Unemployment Insurance (UI) eligibility to a significant number of
``gig'' or 1099 workers. These workers often face the greatest lag
between income loss and access to benefits.
Some have suggested using consumer finance applications (apps) to
reduce processing overhead, decrease fraud, and enable automation
resulting in streamlined access to benefits.
Do you believe that states should use available funds to modernize
UI systems and prevent fraud by creating partnerships with such
consumer finance apps?
Answer. The pandemic has only underscored states' desperate need
for technological support and improvements. Many state systems are
operating on outdated technology, which made it difficult for them to
rapidly respond to changes in law and economic conditions. Part of our
plan for the $2 billion appropriated under the American Rescue Plan Act
is to address this problem by centrally developing open, modular
technology solutions that states may adopt as part of ongoing
modernization and improvement efforts. Shared IT solutions will be
designed to integrate with state systems and will focus on the needs
that are shared across states, while supporting states to implement and
continue operating state specific elements. DOL's vision is to provide
software to support end-to-end administration of UI, including benefit
delivery, employer tools, and appeals. As part of this effort, DOL will
consider all possible IT solutions that will assist states in
modernizing their systems and preventing fraud, including consumer
finance applications. DOL will work with the IT staff in the States to
develop and execute a plan that builds resilience in the UI systems
across the country.
Question. Is the Department of Labor considering issuing guidance
in regard to the ability of the states to use third-party income
verification technology to accurately verify 1099 and gig worker income
distribution?
Answer. Within the scope of the temporary Pandemic Unemployment
Assistance (PUA) program authorized by the Coronavirus Aid, Relief, and
Economic Security (CARES) Act, as amended, DOL has advised states
through webinars and individual technical assistance requests regarding
the use of third parties when obtaining documentation to verify 1099
income distribution for purposes of eligibility. Because the Department
has already provided information to states on using third parties to
verify income for PUA claimants and the program will end shortly, the
Department does not plan on issuing guidance on using third party
income verification technology.
______
Questions Submitted by Senator Patrick J. Leahy
unemployment insurance it modernization
Question. The COVID-19 pandemic highlighted the cracks in the
foundation of many critical support systems across all levels of
government, including the unemployment insurance system. After 15 very
long months, Vermont is finally back to its pre-pandemic unemployment
levels of 2.6 percent. The State has reinstated its work search
requirements, and plans to allocate Federal unemployment benefits
through the summer.
In April, your Department contacted the Vermont Department of Labor
requesting that they re-process thousands of Federal unemployment
benefit claims. During this difficult and unprecedented time, the state
was trying to get money out the door to people in need as fast as they
could. I, along with the rest of the Vermont congressional delegation,
wrote you in late April about the need for flexibility when it came to
the reprocessing of unemployment insurance claims given to claimants
for the ``able and available'' eligibility criteria.
While the response from your Department recognized the strain under
which state UI programs are operating, and stated that you will
continue to provide the state with technical assistance to fulfill the
Department's request, the Vermont delegation did not receive a response
to our inquiry until last week, on July 7. I appreciate your
Department's willingness to work with the state, but this was a long-
delayed response. I hope the Department will keep me and my staff
updated on this issue, as the state is doing, and in the future, I hope
the responses to my office will be received in a timelier manner.
One issue highlighted by the pandemic is how many smaller, rural
states including Vermont lack adequate, modern unemployment insurance
technology. While trying to process thousands of new unemployment
claims, the Vermont Department of Labor, for example, had to work with
a 50-year-old computer mainframe that repeatedly froze and crashed the
system at the beginning of the pandemic in the spring of 2020. I
appreciate your Department's request for $100 million to bolster state
Department of Labor's IT systems to administer unemployment, which is
on top of the $2 billion committed in the American Rescue Plan for the
same purpose.
How will your Department work to ensure that departments of labor
with older unemployment insurance IT systems, such as Vermont's 50-
year-old mainframe, are prioritized when administering UI modernization
funding?
Answer. The Department welcomes the $2 billion that Congress
provided in the American Rescue Plan Act and agrees that UI technology
and infrastructure modernization is urgently needed. It is critical
that state systems operate on a high-quality technology infrastructure
that enables them to administer their UI programs equitably and
efficiently, so all eligible unemployed workers have timely and
meaningful access to this vital benefit. Formulating large scale
spending plans across the UI system, which is comprised of 53 different
programs operated by the states, the District of Columbia, Puerto Rico,
and the U.S. Virgin Islands, requires multiple complex considerations.
The Administration is fully engaged in developing detailed plans to
achieve the goals and purposes set in the American Rescue Plan Act and
will keep Congress informed of those plans and progress on the
implementation of this important project.
The Department has engaged with states on this topic. The
Department conducted an initial webinar with state UI agencies on June
22, 2021, to share some of the current plans and approach on pursuing
UI information technology modernization. The webinar also solicited
states for engagement and partnership in these activities. Since then,
seven states have begun working with the U.S. Department of Labor (DOL)
and the U.S. Digital Service in research partnerships designed to help
fill in research gaps and provide input on the current and future
stages of UI modernization. Also, there have been follow-up virtual
office hours offered to states for further conversations on this topic.
All states should benefit from the funding provided in the American
Rescue Plan Act. As a state modernizes its IT system, there may be
opportunities to take advantage of the central, modular, open
technology solutions developed through this DOL/state partnership. DOL
is also deploying teams of experts, initially to six states, on a
voluntary basis to help identify process improvements that can speed
benefit delivery, address equity, and fight fraud (i.e., Tiger Teams).
The Tiger Teams can provide support, including funding, as states like
Vermont look at business processes through a fraud-fighting and equity
lens in the course of modernization. Additionally, DOL is making grants
to states available to promote equity and fight fraud. These grants
will be designed to help states improve worker access to the UI system,
while helping states make system improvements that will safeguard them
against fraud.
workforce shortages
Question. Even as Vermont's unemployment rate has fallen back to
pre-pandemic levels, workforce shortages remain and no sector has been
spared. Businesses in smaller, more rural states like Vermont, have
struggled for decades to address skilled workforce shortages--whether
it is in the healthcare, education, child care, or manufacturing
industry. Your Department's budget requests $3.7 billion, a 6 percent
increase, for the Workforce Innovation and Opportunity Act and Wagner
Peyser state formula grants to make employment services and training
available to dislocated workers impacted by the COVID-19 pandemic.
How will your Department work to ensure that the DOL's workforce
development help dislocated workers in rural states like Vermont that
currently lack the services available to provide workers with the
skills necessary to re-enter the post-pandemic economy?
Answer. The Department is working to ensure that all American
workers and job seekers, including those in Vermont, have access to the
services needed to make them ready for good jobs with family-sustaining
wages. The COVID-19 pandemic created widespread economic disruption and
further highlighted pre-existing deficiencies in the availability of
opportunities for all Americans to find good-paying, safe employment.
While WIOA funding allotments to states are set by a statutory formula,
the fiscal year 2022 Budget reflects the Department's continued
commitment to help American workers and job seekers, particularly those
from disadvantaged communities, get back on their feet, access job
training, and find pathways to high-quality jobs that can support a
middle-class life. The fiscal year 2022 Budget requests $3.7 billion
for WIOA programs, a $203 million increase over the fiscal year 2021
funding. The Budget includes increases of approximately $37 million for
the Adult Program, $94 million for the Dislocated Worker Formula
Program, $100 million for Dislocated Worker Grants (DWG), and $43
million for the Youth Program. This request will make employment
services and training available to more dislocated workers, low-income
adults, and disadvantaged youth who have been hurt by the economic
impacts of the COVID-19 pandemic.
The fiscal year 2022 Budget also includes the American Jobs Plan,
an investment that will create millions of high-quality jobs and
rebuild our country's infrastructure. This includes investments in
American workers--providing people with the skills they need to
succeed, strengthening the pathways to success, and ensuring that the
jobs that are created are high quality. Structural racism and
persistent economic inequities have undermined opportunity for millions
of workers, and these investments will prioritize underserved
communities and communities negatively impacted by the transforming
economy. The United States currently spends just one-fifth of the
average that other advanced economies spend on workforce and labor
market programs.
The Department included legislative proposals to implement the
American Jobs Plan, totaling $81.5 billion over 10 years, to address
these multiple challenges. This investment in proven workforce
development models includes:
--Creating and expanding sector-based training programs;
--Providing comprehensive support for dislocated workers to enable
their participation in high-quality training programs;
--Expanding Registered Apprenticeship and pre-apprenticeship
opportunities;
--Building community colleges' capacity to deliver high-quality job
training programs;
--Expanding access to evidence-based intensive, staff-assisted career
services;
--Providing subsidized jobs to workers with barriers to employment;
--Expanding workforce development services for justice-involved
individuals; and
--Phasing out the subminimum wage provided to workers with
disabilities while expanding their access to competitive,
integrated employment opportunities.
There are several current funding sources that may be able to
support rural communities in addressing workforce transition.
First, each state may reserve up to 15 percent of their WIOA
funding for statewide activities and an additional 25 percent of the
Dislocated Worker formula allotment for Rapid Response activities. Both
statewide and Rapid Response activities can be focused on prioritizing
business engagement activities and layoff aversion efforts. Business
engagement helps to develop long-term relationships with the business
community. It enables the public workforce system to partner with
businesses to play a more significant part in understanding their
workforce needs, both currently and in the future. Statewide resources,
or other WIOA resources, can then be used to train workers in the
specific skills these businesses need.
Second, state or local workforce areas may request additional
funding from the Department through the National Dislocated Worker
Grant (DWG) program when qualifying events occur, including large
layoffs or a number of smaller layoffs that add up to a larger impact.
DWG funds supplement the regular WIOA formula resources and allow
states to provide critical workforce services to more unemployed
workers than would otherwise be the case.
Lastly, the Department funds several other grant programs that may
benefit rural states and communities across the country. For example,
on June 28, 2021, the Department announced the Comprehensive and
Accessible Reemployment through Equitable Employment Recovery (CAREER)
DWG. CAREER DWGs are designed to fund strategies and activities to help
reemploy dislocated workers most affected by the economic and
employment fallout from the COVID-19 pandemic, in particular, those
from historically marginalized communities or groups and those who have
been unemployed for an extended period or who have exhausted UI or
other Pandemic Unemployment Insurance programs.
Another example is the competitive H-1B Rural Healthcare grants. In
January 2021, the Department awarded $40 million in funding to rural
communities through partnerships of public and private entities to
address rural healthcare workforce shortages across the country. This
investment is addressing a very specific need that was exacerbated
during the pandemic. It aims to increase the number of individuals
training in healthcare occupations that directly impact patient care
and alleviate healthcare workforce shortages by creating sustainable
employment and training programs in healthcare occupations serving
rural populations.
The Administration also has requested $100 million in the next
fiscal year to enable states to overcome the loss of legacy industries
or persistent employment challenges and work towards a clean energy
economy, helping to ensure steady employment opportunities into the
future.
regional apprenticeship program
Question. A primary focus of the Department of Labor's budget
request for fiscal year 2022 is a significant increase of Federal
funding for the Registered Apprenticeship Program of $100 million,
totaling $285 million for the program, which is a 154-percent increase
from fiscal year 2021. Apprenticeship programs add to the important
workforce development role in helping people succeed in learning for
the jobs of today and tomorrow. Many states, including Vermont, must
connect jobseekers to better paying jobs that are in high-demand in
order to continue to have a healthy economy. More than 90 percent of
apprentices find employment after completing their programs, with
graduates earning an average starting salary of more than $60,000.
The fiscal year 2022 budget request highlights the need for the
Registered Apprenticeship Program to focus on expanding access to the
model for historically underrepresented groups, including women and
people of color, and in high-growth sectors where apprenticeships are
underutilized. Despite the need for innovative programs to stem the
demographic trends of aging and shrinking rural areas, small rural
states such as Vermont have struggled with meeting some of the criteria
for the Department's Apprenticeship program. Expanding the Department's
partnership with regional commissions would ensure that small rural
areas can also build long-term community capacity and increase economic
competitiveness.
What is the Department's plan for ensuring that the increased
funding request for the Registered Apprenticeship Program also benefits
people who live in small rural states where the program's criteria has
historically been a barrier to access?
Answer. The Department is acutely aware of the need for improving
conditions in rural areas and reaching underserved populations and has
previously invested in the expansion of Registered Apprenticeships in
states, including small rural states, and is committed to continuing
these efforts through future grant funding.
Previously, the Department awarded several grants supporting
efforts to address access barriers to Registered Apprenticeship
Programs in rural areas. These include Registered Apprenticeship grants
awarded to states in 2016, 2018, 2019, and 2020 \34\ to support
building state capacity to expand Registered Apprenticeship. The
Vermont Department of Labor was a recipient of these awards in each of
those 4 years. Since 2016, according to the Department's records the
State of Vermont has seen a nearly 70 percent increase in the number of
active apprentices in Registered Apprenticeship programs, including
over 2,600 new apprentices during this period. In addition, in January
2021, the Department awarded nearly $40 million in grants as part of
the H-1B Rural Healthcare grant program, focused on addressing
healthcare workforce shortages by creating sustainable employment and
training programs in healthcare occupations serving rural populations.
This funding opportunity allowed applicants to propose a wide range of
training models, including Registered Apprenticeship Programs (RAPs)
to, meet the healthcare workforce needs of rural areas.
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\34\ https://www.apprenticeship.gov/investments-tax-credits-and-
tuition-support/active-grants-and-contracts.
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Most recently, the Department awarded more than $99 million to
states as part of the State Apprenticeship Expansion, Equity, and
Innovation \35\ grants to bolster states' efforts to expand programming
and inclusive recruitment strategies to attract a diverse workforce.
The awards include more than $85 million for states that demonstrated a
commitment to increasing their diversity, equity and inclusion efforts.
These grants also aim to develop partnerships with new industries and
non-traditional occupations, including industry sectors hardest hit by
the pandemic, and align Registered Apprenticeships with other work-
based learning opportunities within state education and workforce
systems. In addition, to ensure this funding opportunity could support
the diverse needs of small rural states, medium-sized, and large states
the funding opportunity allowed for a broad funding request range (from
$2 million up to $10 million) with performance outcome targets that
were commensurate with the amount of funding requested.
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\35\ https://www.apprenticeship.gov/investments-tax-credits-and-
tuition-support/active-grants-and-contracts.
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Further, to better facilitate the expansion of Registered
Apprenticeship, including in rural areas, the Department also awarded
nearly $31 million through cooperative agreements to establish four
Registered Apprenticeship (RA) Technical Assistance (TA) Centers of
Excellence \36\ to provide technical assistance to key apprenticeship
stakeholders. These RA TA Centers of Excellence will provide technical
assistance on a national scale focused on: (1) diversity and inclusion;
(2) strategic partnership and system alignment; (3) apprenticeship
occupations and standards; and (4) data and performance best practices.
Rural areas, as well as all states, will benefit from the technical
assistance being provided by these centers.
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\36\ https://www.apprenticeship.gov/investments-tax-credits-and-
tuition-support/active-grants-and-contracts.
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A focus of all of the Department's investments awarded in 2021 is
to fund opportunities to support innovation in Registered
Apprenticeship expansion efforts allowing states maximum flexibility
for determining where they should target resources. Such efforts may
include creating access for underrepresented populations; developing
distance learning approaches; identifying promising practices with
employer incentives that could bring employers on board, especially in
rural areas; and ensuring industries or occupations negatively impacted
by the COVID-19 pandemic are supported.
In fiscal year 2022, the Department will prioritize investments
that continue to expand the capacity of states to build and expand the
apprenticeship model to new sectors and occupations, increase access
for historically underrepresented groups; and address access barriers
to Registered Apprenticeship Programs in rural areas. The Department
will continue looking for additional opportunities to further these
efforts.
Question. Has the Department considered further utilizing its
partnerships with regional commissions and authorities to expand access
to vital workforce development programs such as the Regional
Apprenticeship Program? How can these partnerships best be utilized?
Answer. The Department believes partnerships that support workforce
system integration are critical to expand access to Registered
Apprenticeship Programs. This includes building partnerships with
governors, workforce agencies, workforce development boards, and
interdepartmental Federal leaders to further align registered
apprenticeship with other work-based learning opportunities within
state education and workforce systems.
As these partnerships are critical to expanding access to
Registered Apprenticeship Programs, the Department has and will
continue to fund activities that support building strategic
partnerships and system alignment. Most recently, the Department
awarded more than $99 million to states as part of the State
Apprenticeship Expansion, Equity, and Innovation \37\ (SAEEI) grants to
bolster states' efforts to expand programming and inclusive recruitment
strategies to attract a diverse workforce. Under these grants, states
must explore new and expanded opportunities with industry, employers,
education and training providers, the workforce system, state and local
governments, labor organizations, and other entities, to better
coordinate and maximize resources and assistance across Federal, state
and local funding streams, as well as from the private sector
enrollment in and access to apprenticeship opportunities that support
workforce system integration.
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\37\ https://www.apprenticeship.gov/investments-tax-credits-and-
tuition-support/active-grants-and-contracts.
---------------------------------------------------------------------------
Additionally, the Department also awarded nearly $31 million
through cooperative agreements to establish four Registered
Apprenticeship (RA) Technical Assistance (TA) Centers of Excellence
\38\ to provide technical assistance to key apprenticeship
stakeholders. One of the RA TA Centers funded will support strategic
partnerships and system alignment. Specifically, this center will focus
on establishing, building, and sustaining partnerships that support
system alignment of the national workforce and education systems to
accelerate Registered Apprenticeship Program adoption and expansion.
This RA TA Center of Excellence will provide technical assistance on a
national scope to Registered Apprenticeship Program sponsors, and will
also support state and local workforce development boards, American Job
Center programs and operators, governors and other essential
stakeholders that drive and inform economic and workforce development
policies and programs.
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\38\ https://www.apprenticeship.gov/investments-tax-credits-and-
tuition-support/active-grants-and-contracts.
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The Department is constantly striving to find new and better ways
to connect with the workforce system and its partners.
SUBCOMMITTEE RECESS
Senator Murray. With that, the subcommittee is adjourned.
[Whereupon, at 11:12 a.m., Wednesday, July 14, the hearings
were concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]
DEPARTMENT OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2022
----------
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
[Clerk's note.--The subcommittee was unable to hold
hearings on departmental and nondepartmental witnesses. The
statements and letters of those submitting written testimony
are as follows:]
DEPARTMENTAL WITNESSES
Prepared Statement of America's Public Television Stations and
the Public Broadcasting Service
On behalf of America's 158 public television licensees, we
appreciate the opportunity to submit testimony for the record on the
importance of federal funding for local public television stations and
PBS (Public Broadcasting Service). We urge the Subcommittee to support
$565 million in two-year advance funding for the Corporation for Public
Broadcasting (CPB) in FY 2024, $20 million for the Public Broadcasting
Interconnection System in FY 2022 and $30 million for the Ready To
Learn program at the Department of Education in FY 2022.
corporation for public broadcasting: $565 million (fy 2024)
two-year advance funded
Public television plays a key role in educating our children;
providing job training; preserving our diverse, dynamic culture and
democracy; and keeping Americans informed, safe and healthy. Public
television's essential services have never been more critical than
during the COVID-19 pandemic, when local public television stations in
all 50 states provided enhanced educational services and content to
help support students, families, teachers, and schools with the sudden
challenge of virtual learning.
Federal funding for CPB is essential to making these services
available to all Americans, including those in rural and underserved
areas, and this funding enjoys the overwhelming support of the American
people. At about $1.40 per person per year, this funding provides an
enormous return on investment for all Americans.
Yet these vital community-based services were level-funded at $445
million for a decade--resulting in an approximate $100 million in lost
purchasing power.
Recognizing this loss, we appreciate that Congress increased the
forward funded CPB appropriation by $20 million for FY 2022 and an
additional $10 million for FY 2023.
While public broadcasting is grateful for these increases, The
public broadcasting system is still about $75 million, in inflation-
adjusted dollars, behind where the system was 10 years ago, at a time
when it is bearing the costly expense of providing access to content on
ever emerging platforms and stations continue to offer more and more
essential services to their communities.
Public broadcasting respectfully requests that Congress take
another substantial step toward securing our current and future public
service goals in the FY 2022 appropriations process.
The $565 million that public broadcasting is requesting in FY 2022
for FY 2024 will help restore lost purchasing power and enable local
stations to leverage advancements in technology and make investments in
the future that will educate more children and adults, provide
additional critical resources and capabilities to teachers and schools,
further enhance public safety and expand the civic leadership work of
local stations.
Given the success of public media, and its potential to do so much
more for so many, it is sound public policy to increase federal funding
for this valuable service that provides an exceptional return on
investment.
Education
Public media is committed to education and service for all
Americans. Public broadcasting allows people at all income levels and
from all parts of the country-rural and urban-to have access to
consistent, high-quality, diverse content for free. This educational
programming is readily available to children, parents, teachers, senior
citizens, those pursuing their high school equivalency degrees, and
many others.
Since last spring, as schools across the country shifted to remote
learning in the face of the COVID-19 pandemic, local public television
stations rolled out new education initiatives, including curated At-
Home Learning broadcasts, airing instructional lessons created by
teachers, and educational datacasting pilots to serve students without
internet connectivity. These resources provided critical support to
schools, teachers, and parents and helped bridge the digital gap for
rural and underserved students. This extraordinary response by public
television stations, many of which partnered with state and local
education agencies, has provided much needed educational resources and
support in communities across the country.
Public television's educational broadcast content has helped more
than 90 million pre-school age children get ready to learn and succeed
in school. Beyond the iconic, proven educational programming, PBS, in
partnership with local public television stations and school districts
provides additional content directly to classrooms and homes through
PBS LearningMedia--which provides access to tens of thousands of State
curriculum-aligned digital learning objects--including videos,
interactives, lesson plans and more--for use in K-12 classrooms and at
home. Content is sourced from the best of public television in addition
to material from the Library of Congress, National Archives, NASA and
other high-quality sources. PBS LearningMedia provided teachers and
students with critical resources and digital content and the number of
users grew by 240% during the pandemic.
Additionally, local public television stations throughout the
country have partnered with PBS to bring a first-of-its kind, free PBS
KIDS 24/7 channel and live stream to their communities--providing kids
throughout the country with the highest level of educational
programming, available through local stations any time, over-the-air
and streaming. During the COVID-19 pandemic, many stations are using
this expanded broadcast capacity to directly serve families and
students from Pre-K--12 with state standards aligned educational
content and instructional content created by teachers. Last year, 60%
of kids ages 2-8 watched PBS KIDS content. Parents also looked to
public television for educational resources, with PBS Parents users
increasing by 80% during the pandemic.
Public television stations are also leaders in adult education.
Public television operates the largest nonprofit GED program in the
country, helping tens of thousands of second-chance learners earn their
high school equivalency degree. In addition, public television stations
are leaders in workforce development, including retraining American
veterans, by providing digital learning opportunities for training,
licensing, continuing education credits, soft skills and more.
Partners in Public Safety
Public broadcasting stations throughout the country are leading
innovators and essential partners to local public safety officers. In
partnership with FEMA, PBS WARN uses the public television
interconnection system and local stations' broadcast infrastructure to
support the Wireless Emergency Alert (WEA) system that enables cell
subscribers to receive geo-targeted text messages in the event of an
emergency-reaching citizens wherever they are.
The February 2019 Report from the FEMA National Advisory Council on
Modernizing the Nation's Public Alert and Warning System specifically
recommends, ``Encouraging use of public media broadcast capabilities to
expand alert, warning, and interoperable communications capabilities to
fill gaps in rural and underserved areas.''
In addition, and separate from the WEA system, local public
television stations' digital infrastructure and spectrum enable them to
provide state and local officials with critical emergency alerts,
public safety, first responder and homeland security services and
information during emergencies through a process known as datacasting.
Datacasting uses broadcast spectrum to send encrypted data and video to
first responders with no bandwidth constraints.
In partnership with local public television stations and local law
enforcement agencies, the U.S. Department of Homeland Security (DHS)
has conducted several successful pilots throughout the country that, in
addition to other local initiatives, prove the effectiveness of
datacasting in a range of use cases including: flood warning and
response; enhanced 911 responsiveness; over-water communications;
faster early earthquake warnings; multiagency interoperability; rural
search and rescue; high profile, large event crowd control; and
assistance with school safety, including in areas that lack broadband
or LTE services.
As a result of the successful pilots, the DHS Science and
Technology Directorate has partnered with America's Public Television
Stations (APTS) to maximize and promote datacasting technology and the
opportunity to partner with local public television stations in
communities nationwide.
Additionally, stations are increasingly partnering with their local
emergency responders to customize and utilize public television's
infrastructure for public safety in a variety of critical ways, with
many serving as their states' Emergency Alert Service (EAS) hub for
weather and AMBER alerts.
Providing Civic Leadership
Public television strengthens the American democracy by providing
citizens with access to the history, culture and civic affairs of their
communities, their states and their country. Through the pandemic,
public television has been providing essential front-line coverage to
ensure Americans have the facts they need to stay healthy and local
information on where they can turn for help if they need it.
For the 18th year in a row, PBS was ranked the most trusted among
national institutions. That trust is more important than ever. Over the
last year, when inaccurate information could endanger people's lives,
Americans could tune into their local public television station or view
their online resources for trusted information that could help keep
them safe.
Local public television stations often serve as the state-level
``C-SPAN'' covering state government actions. As some of the last
locally controlled media, public television stations also provide more
public affairs programming, forums for discussion of local issues such
as the opioid crisis, local history, arts and culture, candidate
debates, agricultural news, and citizenship information of all kinds
than anyone else. What truly sets public television stations apart is
that stations treat their viewers as citizens rather than consumers.
Public Broadcasting is a Smart Investment
All of this public service is made possible by the federal funding
to CPB. This federal investment sustains the public service missions of
public television, which are distinct from the mission of commercial
broadcasting and will not be funded by private sources, as the
Government Accountability Office concluded in a 2007 study commissioned
by Congress.
The need for federal investment is particularly acute in small-town
and rural America, where lower population density, a lack of corporate
and philanthropic support, and challenging topography make the
economics of local television and public service more challenging. As a
result, public broadcasters are sometimes the only local broadcaster
serving rural communities-and only with the help of the federal
investment.
For all stations, federal funding is the ``lifeblood'' of public
broadcasting, providing indispensable seed money to stations to build
additional support from state legislatures, foundations, corporations,
and ``viewers like you.''
For every dollar in federal funding, local stations raise six
dollars in non-federal funding, creating a strong public-private
partnership providing a valuable return on investment and supporting
approximately 20,000 jobs across America.
And yet, until two years ago, this critical funding remained flat
for a decade, forcing stations to make difficult programming, staffing
and service decisions as operational costs rose with inflation, while
CPB funding did not. Despite this severe financial constraint, local
public television stations have continued their deep commitments to the
communities they serve.
The $565 million that public broadcasting is requesting in FY 2024
is both prudent and necessary for the continued health of local
stations and the public broadcasting system as a whole--and for long-
delayed enhancements of the essential education, public safety and
civic leadership services described above.
Two-Year Advance Funding
Two-year advance funding is essential to the mission of public
broadcasting. This longstanding practice, proposed by President Ford
and embraced by Congress in 1976, establishes a firewall insulating
programming decisions from political interference, enables the
leveraging of funds to ensure a successful public-private partnership,
and provides stations with the necessary lead time to plan in-depth
programming and accompanying educational materials-all of which
contribute to extraordinary levels of public service and public trust.
Local stations leverage the two-year advance funding to raise
state, local and private funds, ensuring the continuation of this
strong public-private partnership. These federal funds act as the seed
money for fundraising efforts at every local station, no matter its
size. Advance funding also benefits the partnership between states and
stations since many states operate on two-year budget cycles.
Finally, the two-year advance funding mechanism gives stations and
producers, both local and national, the critical lead time needed to
raise the additional funds necessary to sustain effective partnerships
with local community organizations and engage them around high-quality
programs. Producers like Ken Burns, Henry Louis Gates, Jr. and Stanley
Nelson, spend years developing programs like The Vietnam War, Country
Music, The Black Church, Tell Them We Are Rising: The Story of Black
Colleges and Universities and a documentary on Muhammed Ali airing this
fall. It would be impossible to produce this in-depth programming and
the curriculum-aligned educational materials that accompany it without
the two-year advance funding.
public broadcasting interconnection: $20 million
The public television interconnection system is the infrastructure
that connects PBS and national, regional and independent producers to
local public television stations around the country. The
interconnection system is essential to bringing public television's
educational, cultural and civic programming to every American
household, no matter how rural or remote. Without interconnection,
there is no nation-wide public media service. The interconnection
system is also critical for public safety, providing key redundancy for
the communication of presidential alerts and warnings, and ensuring
that cellular customers can receive geo-targeted emergency alerts and
warnings.
Congress has always provided federal funding for periodic
improvements of the interconnection system. In FY 2018, Congress moved
to fund interconnection for public broadcasting on an annual, rather
than decennial, basis to enable dynamic, incremental upgrades in accord
with increasingly rapid advances in technology. Public television seeks
level funding of $20 million for interconnection in FY 2022.
ready to learn: $30 million (department of education)
The U.S. Department of Education's Ready To Learn (RTL) competitive
grant program, reauthorized in the Every Student Succeeds Act, uses the
power of public television's on-air, online, mobile, and on-the-ground
educational content to build the literacy and STEM skills of children
between the ages of two and eight, especially those from low-income
families.
Through their RTL grant, CPB and PBS deliver evidence-based,
innovative, high-quality transmedia content to improve the math and
literacy skills of high-need children. CPB, PBS, and local stations
have ensured that the kids and families that are most in need have
access to these groundbreaking and proven effective educational
resources. In addition to children, this outreach focuses on adults who
care for kids to empower and help them understand the important role
they play in their children's educational success.
RTL investments have supported the production and academic rigor of
PBS KIDS series: Elinor Wonders Why, Peg + Cat, SuperWhy!, Martha
Speaks, Odd Squad and Molly of Denali--a curious and resourceful 10-
year-old Alaska Native girl who lives in the fictional village of Qyah,
Alaska--and other iconic programming for children.
But this investment does not solely rely on trusted, educational
children's programming. CPB, PBS, and local public television stations
employ a national-local model to reach parents, teachers, and
caregivers on-the-ground in communities to help them make the most of
these media resources locally. These include television, online and
mobile apps, digital technology, mobile learning labs and on the ground
events that provide valuable content and support to local school
districts, county non-profits, preschools, homeschools, Head Start and
other daycare centers, libraries, museums, and Boys and Girls Clubs,
among others.
Results
RTL is rigorously tested and evaluated to assess its impact on
children's learning and to ensure that the program continues to offer
children the tools they need to succeed in school. Since 2005, more
than 100 research and evaluation studies have shown RTL literacy and
math content engages children, enhances their early learning skills and
allows them to make significant academic gains, helping bridge the
achievement gap. Highlights of recent studies show that:
--Children from low-income households who were provided with RTL-
funded Molly of Denali videos, digital games, and activities
were better able to solve problems using informational text, -
oral, written, or visual text designed to inform--a fundamental
part of literacy that paves the way for future learning,
particularly in social studies and the sciences. After only
nine weeks of access, this impact is equivalent to the
difference in reading skills a first-grader typically develops
over three months.\1\
---------------------------------------------------------------------------
\1\ Kennedy, J. L., Christensen, C., Maxon, T., Gerard, S., Garcia,
E., Hupert, N., Vahey, P., & Pasnik, S. (2021).
---------------------------------------------------------------------------
--Ready To Learn-funded resources from the PBS KIDS series The Cat in
the Hat Knows a Lot About That! increased science learning in
children from low-income households and had a positive impact
on children's understanding of core physical science concepts
of matter and forces-equivalent to the difference in science
knowledge an early elementary student develops over five
months.\2\
---------------------------------------------------------------------------
\2\ (Grindal, T., Silander, M., Gerard, S., Maxon, T., Garcia, E.,
Hupert, N., Vahey, P., Pasnik, S. (2019). Early Science and
Engineering: The Impact of The Cat in the Hat Knows a Lot About That!
on Learning. New York, NY, & Menlo Park, CA: Education Development
Center, Inc., & SRI International.)
---------------------------------------------------------------------------
An Excellent Investment
In addition to being research-based and teacher tested, RTL also
provides excellent value for our federal dollars. In the last five-year
grant round, public broadcasting leveraged an additional $50 million in
non-federal funding to augment the $73 million investment by the
Department of Education. RTL exemplifies how the public-private
partnership that is public broadcasting can change lives for the
better.
A funding level of $30 million is requested in FY 2022 to support
current grantees and further enhance the discoverability and impact of
Ready To Learn created content and the quantity and scope of local
station outreach to the kids, families, teachers and schools that need
it the most.
Given the rigorous, thoughtful educational research and evaluation
that goes into the creation of Ready To Learn content, Ready To Learn
grants are awarded every five years and supported through annual
appropriations. Funding in FY 2022 would provide the third year of
funding in the latest grant round. Providing $30 million for Ready To
Learn in FY 2022 will ensure that CPB, PBS and stations can continue to
create the highest quality, proven-effective kids educational media,
meeting kids, caregivers and teachers where they are on a variety of
platforms, while expanding local, on-the-ground outreach through local
partners.
conclusion
Americans across the political spectrum rely on and support federal
funding for public broadcasting because we provide essential local
education, public safety, and civic leadership services that are not
available anywhere else. And none of this would be possible without the
federal investment in public broadcasting.
Federal funding is the great equalizer that ensures that the best
of public broadcasting is available in both the urban centers of our
great cities and in Native American communities in America's heartland
and everywhere in between.
Federal funding for CPB is what ensures that young children in
Appalachia have the same access to the unparalleled PBS KIDS content as
their counterparts in Los Angeles. And federal funding is what ensures
that all households, regardless of their ability to pay for cable or
streaming subscriptions have access to local programming and the best
of NOVA, Masterpiece, NewsHour, Great Performances, and so much more.
Public broadcasters are the only broadcasters that reach nearly 97%
of U.S. households, and it is CPB funding that makes this possible.
For all of these reasons we request that Congress continue its
commitment to the highly successful, hugely popular public-private
partnership that is public broadcasting by providing $565 million in FY
2024 for CPB in addition to $20 million in FY 2022 for public
broadcasting's interconnection system and $30 million in FY 2022 for
the Ready To Learn Program.
______
Prepared Statement of the National Public Radio
Chairwoman Murray, Ranking Member Blunt and Members of the
Subcommittee,
Thank you for this opportunity to urge the Subcommittee's support
for a robust annual federal investment of $565 million in FY 2024 in
public broadcasting through the Corporation for Public Broadcasting
(CPB) and $20 million in FY 2022 to continue upgrading the public
broadcasting interconnection system and other technologies and services
that create system efficiencies.
As the President and CEO of National Public Radio (NPR), I offer
this statement on behalf of the public radio system, a nonprofit public
service media enterprise that includes NPR, more than 1,000 public
radio stations, other producers and distributors of public radio
programming, and many stations, large and small, that create and
distribute content through the Public Radio Satellite System(r)
(PRSS(r)). Every day, public radio connects with millions of Americans
on the air, online, through smart speakers and mobile devices, and in
person to explore current news, music, enduring ideas, and what it
means to be human. About 98.5% of the U.S. population is within the
broadcast listening area of one or more public radio stations.
Federal funding provided by Congress to the CPB enables local,
noncommercial radio stations to provide news, information, and cultural
programming to meet the needs of local communities and offer diverse
perspectives. This funding is the bedrock of the public broadcasting
system. On average, for every $1 in federal grant money that a public
radio station receives, it raises $10 locally from audiences and local
sponsors. Public radio stations are locally owned and managed, and
thereby accountable to the local leaders and listeners they serve.
Many newspapers have lost circulation and advertisers, and are
closing their doors, eliminating sources of local news. More than 3,100
journalists at local public radio stations help to fill this need--
bringing trusted, reliable, independent news and information of the
highest editorial standards to keep communities connected. On May 6,
2021, the Radio Television Digital News Association recognized this
quality journalism by awarding public radio 277 Regional Edward R.
Murrow Awards--80 percent of the 343 awards in U.S. radio categories.
Continued investments in newsgathering capacities at public radio
stations will help ensure that public media can continue to fill the
gap for news and information in America's communities with expanded
local and regional coverage and digital services. CPB is helping to
fund public radio collaboration across key regions. In 2019, NPR and
public radio stations in Texas joined together to launch the first
regional reporting hub. In 2020, NPR and local stations launched a Gulf
states hub covering Mississippi, Alabama, and Louisiana--one of the
most news deprived regions in the country--as well as hubs in
California and the Midwest. Another NPR collaboration funded by CPB--
the Stations Investigations Team-supports local stations' investigative
journalism, helping with technical skills such as data collection and
analysis, as well as training. These collaborative arrangements allow
stations to utilize resources more efficiently, increase the scope of
regional coverage, and promote journalistic skills and mentoring.
Public radio stations play an important role in civics--supporting
state house coverage, reporting on local elections, and fostering
dialogue among communities. On a broader scale, public radio seeks to
connect Americans, including students, through coverage of national
civics issues and questions. For example, with CPB support, New
Hampshire Public Radio produces Civics 101: A Podcast, exploring topics
such as types of civic action, electoral processes, fundamental rights,
landmark Supreme Court cases, and key documents, such as the Magna
Carta. NHPR also provides resources for educators, including teacher
created lesson plans, to use these audio resources in the classroom. By
inspiring audiences of all ages to engage with foundational civics
topics, public radio can support the search for common ground across
the political spectrum.
Throughout the COVID-19 pandemic, public radio stations have
provided life-saving information and documented stories of how the
pandemic affected communities across the nation. In May 2020, a
collaborative reporting project from NPR and The Texas Newsroom found
that COVID-19 testing sites in four major cities in Texas were located
in predominately white neighborhoods, and through the examination of
available testing data, revealed that it was harder for people of color
to find test sites near where they lived. Following this exclusive
report, Dallas County opened two walk-up testing sites in Southern
Dallas, and Governor Greg Abbot announced that the state would bring
more testing to underserved communities. In 2021, NPR and reporters
from The Texas Newsroom and The Gulf States Newsroom teamed up to
examine the availability of COVID-19 vaccination sites, again
identifying disparities in the location of vaccination sites in major
cities in the Southern United States.
At the beginning of the pandemic, as listeners transitioned to
working and living in quarantine, public radio's digital audiences grew
250 percent. Audiences sought insight into the nation's response to the
coronavirus and how their local communities were affected. Public radio
stations provided live blogs on the coronavirus, explanations of public
health orders, and information on the development and distribution of
vaccines. By the end of 2020, public radio station websites
demonstrated continued audience growth, showing a 31 percent year-over-
year growth in average monthly users and a 67 percent increase in
monthly newsletter traffic.
Madam Chairwoman, Ranking Member, and members of the subcommittee,
I would be remiss if I did not thank you for the support you provided
to public radio, and the entire public broadcasting system, through the
Coronavirus Aid, Relief, and Economic Security (``CARES'') Act in 2020
and the American Rescue Plan Act earlier this year. Your support during
this crisis ensured that local public radio stations received needed
resources to maintain essential programming and services for the
communities that depended upon them.
We have seen that the COVID-19 pandemic further demonstrated the
value of public radio embracing the challenges of a multi-platform
media marketplace, while continuing to hold a dominant position in
traditional radio broadcasting. Public radio stations offer original
content through a variety of platforms and channels to reach new
audiences, including terrestrial radio, satellite radio, the web
(desktop and mobile), smart speakers, and podcasts--and application-
driven mobile services on iOS and Android (both phone and tablet) and
via aggregators such as Apple Music, Facebook News, Stitcher, and
TuneIn. The strength of this multi-platform approach is that public
radio can reach listeners wherever they are and attract new and diverse
listeners. For example, Southern California Public Radio--with CPB
support--is reaching out to younger, Latino audiences by producing
innovative, on-demand content and increasing the diversity of its on-
air hosts, producers and production staff. NPR has also partnered with
classrooms across the country in the annual Student Podcast Challenge,
which invites middle school and high school students to work with their
teachers to develop and produce a podcast for the opportunity to be
featured on NPR; a similar challenge is available for college students.
Thousands of students and teachers have participated across all 50
states, utilizing resources designed to support the process in the
classroom, develop journalism and broadcast skills, and connect public
radio to youth audiences.
Public radio is more than journalism. Stations offer communities
access to innovative music, arts, entertainment, and other cultural
programming. Public radio music-format stations play a key role in
supporting noncommercial music in the United States, playing a broad
collection of sounds and styles including jazz, blues, classical, folk,
alternative, bluegrass, zydeco, roots, and other eclectic genres.
Public radio stations make this wide variety of music accessible to
listeners through traditional broadcasts, streaming, live performances,
and music journalism. This programming supports discovery and
creativity, and connects local and national audiences to a broader
cultural conversation thus enriching both hearts and minds. Funding for
CPB plays a key role in enabling stations and program producers to
provide these cultural opportunities.
Public radio would not be possible without the federal funding
provided for the PRSS--the satellite content distribution system on
which the public radio system--including almost all stations, networks,
and producers--generally depends. The federal appropriation would allow
the current satellite-and-internet delivery system to continue to be
modernized and maintained with next-generation equipment and software.
The PRSS is open to all public telecommunications entities,
including independent producers; program syndicators and distributors;
national, state, and local organizations; and public radio stations.
Stations that receive programming distributed by the PRSS range from
those located in remote villages in northern Alaska and on Native
American reservations in the Southwest, to major market stations such
as WNYC in New York City and KUSC in Los Angeles. Through almost 400
downlinks, PRSS transmits programs distributed from NPR, other major
content producers, and more than 100 independent radio producers and
organizations with a variety of formats that include news, public
affairs, documentaries, classical music, and jazz.
CPB's support of interconnection for the PRSS facilitates the cost-
effective and efficient distribution of high-quality, educational
programming to this country's increasingly diverse population. As part
of that mission, the PRSS provides free, or ``in kind,'' satellite
transmission services to distribute programming to un-served or under-
served audiences. Currently, full-time support is given to three
program service groups: Native Voice One serving Native American
listeners; Satelite Radio Bilingue, a Spanish-language service; and the
African American Public Radio Consortium.
The PRSS also plays a vital role in the nation's emergency alert
system by receiving Presidential alerts (also called Emergency Action
Notification (EAN) alerts) fed directly from FEMA, which it can
transmit to public radio stations in the event of a nationwide crisis.
In addition, the PRSS MetaPub service enables local public radio
stations equipped with this technology to issue emergency text and
graphic alerts--such as tornado and hurricane warnings, evacuation
routes, and COVID-19 information--that are visible on screens and
synched with over-the-air broadcasts to mobile phones, HD radios,
``connected car'' smart dashboards, Radio Data System displays, and via
online audio streaming. To date, about 10 percent of interconnected
public radio stations have the capability to issue live text alerts
using the MetaPub system in the event of a natural or humanmade
disaster, such as a chemical spill.
In closing, public radio provides an essential public service for
local communities across the nation--embracing their diversity, telling
their stories, and keeping them informed with trustworthy, independent
news, information, and public safety alerts upon which they rely. Your
support for the CPB appropriation will ensure that public media can
continue to provide these critical services and be positioned to
embrace the future of the media landscape. Thank you for your support
of the public broadcasting system.
[This statement was submitted by John F. Lansing, President and
CEO, National Public Radio.]
NONDEPARTMENTAL WITNESSES
Prepared Statement of the Academy for Radiology & Biomedical
Imaging Research
Madam Chair and members of the Subcommittee, I am Mitchell Schnall,
President of the Academy for Radiology & Biomedical Imaging Research
(Academy), and the Eugene P. Pendergrass Professor of Radiology and
Chair of the Radiology Department at the Perelman School of Medicine at
the University of Pennsylvania. The Academy is more than 200 academic
research departments, patient advocacy groups, industry partners, and
imaging societies that represents thousands of radiologists and
researchers in all 50 states. The Academy is the only advocacy
organization representing the broad spectrum of the imaging research
community by collectively advocating for robust and consistent federal
research funding.\1\ It is my pleasure to submit this testimony on
behalf of the Academy. We strongly support the President's request of
$52 billion for the National Institutes of Health and ask that no less
than $46.111 billion of that be for the NIH's base program budget for
FY2022. Investigator-initiated research continues to be the foundation
of basic science and discovery. The latter figure represents an
increase of $3.177 billion over the FY2021 enacted levels. Moreover,
the Academy supports a proportional increase to the National Institute
of Biomedical Imaging and Bioengineering (NIBIB), resulting in at least
$441.1 million for FY2022--a $30.4 million increase over FY2021. These
base increases reflect approximately 5% above the biomedical research
and development price index (BRDPI). Through consistent, strong funding
for NIH and our national research infrastructure we can continue to
make advancements that will improve the lives of patients with a wide
spectrum of diseases and disorders. The Academy is grateful for the
Subcommittee's past support of NIH and encourages you to continue
advancing biomedical research and radiology and imaging science.
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\1\ https://www.acadrad.org/about-the-academy/.
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Imaging is not limited to any one disease or condition. Instead, it
serves as a necessary diagnostic tool that researchers and clinicians
of all types use to help advance our understanding of biological
systems and how best to develop and deliver treatments benefitting
patients. By improving our imaging tools and techniques, we broaden the
resources available to address many challenging conditions. In my own
work as a clinician-scientist, I use state-of-the-art technologies like
specialized magnetic resonance imaging (MRI) and 3-dimensional
mammography (digital breast tomosynthesis) to improve the diagnosis and
treatment of cancer types, including breast, prostate, and pancreatic,
while also researching rare and orphan diseases.
Imaging Innovation to Help Patients
Imaging tools can apply to a wide range of diseases and disorders
and can have very real impacts on patient outcomes. This results from
Congress's sustained federal investment in biomedical research at NIH
over the last several years. Over time, basic science advancements
translate into a variety of clinical settings, ultimately benefitting
patients. This Subcommittee's continued support of NIH, and
specifically NIBIB and the other Institutes and Centers that support
imaging research, will help generate future breakthroughs across many
biomedical challenges. Moreover, these innovations can be translated
into the commercial products, supporting the biotechnology industry and
jobs. Below are examples of the community's response to the COVID-19
pandemic, advances in detecting and treating cancer, and the role of
imaging in detecting and treating neurodegenerative diseases.
Medical Imaging and Data Resource Center: Merging Diagnostics and
Machine Learning
In the first of a two-year effort launched in 2020, the goal of the
Medical Imaging and Data Resource Center (MIDRC) is ``to foster machine
learning innovation through data sharing for rapid and flexible
collection, analysis, and dissemination of imaging and associated
clinical data...in the fight against COVID-19.'' \2\ MIDRC is an NIBIB-
funded collaboration between the American College of Radiology (ACR),
the Radiological Society of North America (RSNA), the American
Association of Physicists in Medicine (AAPM), and the University of
Chicago. These partners are building an accessible and shareable
database that can be used to accelerate clinical diagnosis, monitoring,
and treatment of COVID-19. Datasets are now being released for public
use. Moreover, MIDRC is developing machine learning tools for
evaluating medical images to determine the likelihood and future
severity of infection, as well as the prognosis for recovery. While
currently focused on Covid-19, the methods can be applied to any large
set of biomedical images to analyze and identify the likelihood of
disease or disorder. Leveraging these innovations and computational
tools augments human evaluation. This technology, using nationwide
data, also improves predictive tools for identifying serious conditions
and recovery prognoses while serving as an ``early warning'' system for
future outbreaks.
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\2\ https://www.midrc.org/.
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Combining Diagnostics and Therapy to Treat Cancer
Recent technological advances in imaging have transformed the
landscape for detecting and treating many types of cancer. Today,
diagnostics and therapeutics can be combined into one action. The
evolving field of theranostics--therapy-diagnostics--uses imaging
agents, called radiotracers, to simultaneously diagnose and deliver
therapy to affected cells. These targeted molecules are engineered to
seek out specific types of cancer cells, which may be part of primary
tumors or circulating throughout the body as metastases. Imaging for
prostate cancer is now 100 times more effective than it was only 15
years ago. And now, these same agents can be loaded with radioisotopes
designed to kill cells, becoming ``smart bombs'' aimed at cancer.
Extensive work is underway to develop smart radiotherapy agents for
numerous cancers including prostate cancer. Other targeted agents
recently approved by the FDA can simultaneously seek out and destroy
neuroendocrine cancer cells, a form of pancreatic cancer. These
advances are helping physicians become much more effective in
diagnosing and treating these and many other types of cancer, including
lymphoma and thyroid cancer. Consequently, the patient receives very
real benefits--the ability to find and treat cancer in a single action
rather than requiring repeated visits, evaluations, and more invasive
procedures. Theranostics, built on research funded by multiple
institutes at NIH, has the potential to further advance society's goal
of making cancer a treatable disease across a broad array of tumor
types.
Detecting Neurodegeneration to Manage Treatments
Every American knows at least one family with a member afflicted by
a neurodegenerative condition such as Alzheimer's disease or another
form of dementia. The inexact and sometimes subtle symptoms of these
conditions in their early stages, combined with the challenges of
studying a living human brain, can make effective diagnoses
challenging. Recent breakthroughs in imaging provide alternative, more
precise tools physicians can use to diagnose and manage the care of
affected patients. New imaging agents allow investigators to detect and
quantify amyloid plaques and Tau proteins in the brains of patients--
two leading indicators for Alzheimer's disease. This ability informs
and accelerates the search for new treatments and methods to predict
which patients may benefit from such therapies. In fact, a recent
clinical trial investigated a new treatment for the removal of amyloid
plaque from patients, an approach enabled by an approved imaging agent
supported by an NIH grant.
Treatment of another neurological condition, Parkinson's disease,
has also advanced because of emerging imaging research. Patients
suffering from essential tremor symptoms, including those with
Parkinson's, can now benefit from therapies in which magnetic resonance
imaging (MRI) images are used to direct sound waves--High-intensity
Focused Ultrasound--in a non-invasive way to alter neuronal connections
and activities. This intervention often leads to instantaneous
improvement in patient symptoms. While not a cure, alleviation of
tremor symptoms allows patients to continue managing their condition by
caring for themselves through actions such as dressing, eating, and
other activities that require fine motor skills.
summary and conclusion
Sustained and robust NIH funding is crucial to advancing our
efforts to understand and ultimately treat a myriad of diseases and
disorders across human systems. NIH investments are also a key economic
driver at local research institutions, and NIH funds flow to every
state in the nation.\3\ If we are to remain a global leader in
biomedical research and innovation, continued, strong support for NIH
is essential. Funding NIH's base program with at least $46.111 billion
will provide the robust support needed to sustain growth for biomedical
research.
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\3\ https://www.unitedformedicalresearch.org/wp-content/uploads/
2021/03/NIHs-Role-in-Sustaining-the-U.S.-Economy-FINAL-3.23.21.pdf.
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Thank you for your strong, continued support of NIH, NIBIB, and all
the Institutes and Centers working to advance our biomedical research
efforts and to improve the lives of patients worldwide. On behalf of
the Academy, I urge you to continue your strong support of our nation's
research and innovation enterprise.
[This statement was submitted by Mitchell Schnall, M.D., Ph.D.,
President,
Academy for Radiology & Biomedical Imaging Research.]
______
Prepared Statement of the Academy of Nutrition and Dietetics
Dear Chair Murray and Ranking Member Blunt,
The Academy of Nutrition and Dietetics appreciates the opportunity
to submit testimony to the subcommittee for FY22 appropriations.
Representing more than 112,000 credentialed nutrition and dietetics
practitioners, the Academy is the world's largest organization of food
and nutrition professionals and is committed to improving the nation's
health with nutrition services and interventions provided by registered
dietitian nutritionists.
For FY22, we strongly urge you to provide funding for the promotion
of the 2020-2025 Dietary Guidelines for Americans by the HHS Office of
Disease Prevention and Health Promotion; the CDC Division of Nutrition,
Physical Activity, and Obesity; and for Americans Older Americans Act
senior nutrition programs. In the Department of Education, we support
the Health Professionals of the Future program proposed in the
President's budget.
Funding: DGA Promotion by the HHS Office of Disease Prevention and
Health Promotion--FY2022 Request: $3 million
The 2020-2025 Dietary Guidelines for Americans were released in
December 2020 and featured new nutrition recommendations for children
from birth through 24 months and pregnant and lactating women. For the
Dietary Guidelines for Americans to achieve their intended reach and
impact, it is essential that the federal government invest in educating
consumers and health care professionals on these new guidelines.
The HHS Office of Disease Prevention and Health Promotion (ODPHP)
and the USDA Center for Nutrition Policy and Promotion (CNPP) and they
should jointly work to develop materials for comprehensive education
campaigns aimed at: (1) educating consumers on how to use the new
Dietary Guidelines to inform their dietary choices; and (2) health care
professionals to align their dietary guidance with the new Guidelines.
The campaign should be informed by scientific research on health
behavior change, as well as input from key stakeholder groups,
including nutrition assistance program participants and administrators,
health care providers, community leaders, and health and nutrition
advocates. The campaign should incorporate educational materials
representing wide diversity of cultural food preferences and should be
available in languages that meet the needs of populations at risk for
diet-related disease.
Funding: Older Americans Act Nutrition Programs (HHS ACL)
The Older Americans Act authorizes a wide array of service programs
that are overseen by the HHS Administration for Community Living and
delivered through a national network of state agencies, area agencies
on aging, and nearly 20,000 service providers.\1\ Most program
participants have household incomes below 100% of the federal poverty
level.\2\ In addition to directly combatting senior hunger during this
time of uncertainty, senior meals programs have also reduced the need
for seniors to leave their homes to get food, helping to limit their
exposure to COVID-19. A significant increase in funding for these
programs would not only allow more seniors to be served but would free
up money for the nutrition assessment and educational components of
these programs that are often sacrificed in order to reduce wait lists
for meals.
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\1\ https://acl.gov/about-acl/authorizing-statutes/older-americans-
act.
\2\ https://fas.org/sgp/crs/misc/IF10633.pdf.
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Congregate Nutrition Services
Congregate Nutrition Services funds nearly 80 million meals per
year for 1.5 million participants and gives seniors access to
socialization. More than one-fifth of participants have been deemed to
be at high nutrition risk. These funds are also used to provide
nutrition screening and counseling to seniors who may be at risk of
malnutrition, food insecurity or other issues. For the duration of the
COVID-19 public health emergency, service agencies have been given the
flexibility to convert their congregate meals programs into drive-up or
grab-and-go programs and to use any surplus funds from their congregate
nutrition services budget to provide home-delivered meals.
Home-Delivered Nutrition Services
Home-Delivered Nutrition Services provides more than 145 million
meals per year to 867,000 participants, with more than half of program
participants categorized as being at high nutrition risk.\3\ The
program also serves as a welfare check for isolated seniors and as a
primary access point for other home- and community-based services. The
demand for this crucial nutrition security program has been
unprecedented during the COVID-19 pandemic.
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\3\ https://www.cdc.gov/nccdphp/dnpao/state-local-programs/
funding.html.
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Funding: CDC Division of Nutrition, Physical Activity, and Obesity--
Division of Nutrition, Physical Activity and Obesity--FY2022
Request: $125 million
The CDC Division of Nutrition, Physical Activity, and Obesity
(DNPAO) oversees grant programs that provide funds to states and
localities to address the obesity epidemic in their communities.\3\
Adult obesity prevalence is at over 42% in 2017-2018.\4\ Obesity-
related conditions include heart disease, stroke, type 2 diabetes and
certain types of cancer that are some of the leading causes of
preventable, premature death. In 2008, the annual medical cost of
obesity in the United States was estimated to be $147 billion; the
medical cost for people who have obesity was $1,429 higher than those
of normal weight. Having obesity is a top risk factor for severe
disease, hospitalization and death from COVID-19. Minority and low-
income communities often lack access to healthful foods and safe places
to be active, and these inequities contribute to obesity and other
chronic disease disparities that are contributing to disproportionate
COVID-19 morbidity and mortality.
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\4\ https://www.cdc.gov/obesity/data/adult.html.
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State Physical Activity and Nutrition Program--FY2022 Request: $60
million
The State Physical Activity and Nutrition (SPAN) grant program at
DNPAO awards competitive grants to states to implement multi-component,
evidence-based strategies at the state and local level to improve
nutrition and physical activity.\5\ With its current funding level,
SPAN is only able to fund 16 states, which is does via five-year grants
(currently FY18-22). DNPAO estimates that it would cost an additional
$1.2 million per state to expand the program, so we are requesting $60
million of the $125 million for DNPAO to go to SPAN to allow every
state to receive SPAN grant funding.
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\5\ https://www.cdc.gov/nccdphp/dnpao/state-local-programs/span-
1807/index.html.
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Funding: Health Professionals of the Future (ED)--FY2022 Request: $200
million
COVID-19's disproportionate impact on communities of color has made
the need for health professional workforce diversity and culturally
competent care more urgent than ever. Historically Black Colleges and
Universities (HBCUs), Tribal Colleges and Universities (TCUs), and
other Minority Serving Institutions (MSIs) have long been leaders in
addressing health equity in America. Specifically, HBCUs graduate 43%
of all African Americans with postsecondary degrees in STEM fields and
roughly 15% of all African American physicians. Despite these
successes, gaps remain, particularly among registered dietitian
nutritionists.
The Health Professionals of the Future proposal \6\ put forth in
the FY22 President's budget would help close these gaps by creating and
funding a competitive grant program that provides funding to MSIs to
create or expand graduate programs that prepare students for high-
skilled jobs in the health care sector and help diversify the
healthcare sector pipeline. Authorized activities would include the
development of a career and educational pathways exploratory system to
assist undergraduate and graduate students in learning about career
opportunities in these fields and connecting students to internships
and jobs; support services to help students complete graduate programs;
scholarships or fellowships for tuition or to support on-the-job
training.
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\6\ https://www2.ed.gov/about/overview/budget/budget22/
justifications/t-highered.pdf#page=147.
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Contact
Please feel free to contact me at [email protected] with any
questions on these important issues. Thank you for the opportunity to
submit our recommendations to the subcommittee.
Sincerely.
[This statement was submitted by Hannah Martin, MPH, RDN, Director,
Legislative and Government Affairs, Academy of Nutrition and
Dietetics.]
______
Prepared Statement of the Ad Hoc Group for Medical Research
The Ad Hoc Group for Medical Research is a coalition of nearly 400
patient and voluntary health groups, medical and scientific societies,
academic and research organizations, and industry. We appreciate the
opportunity to submit this statement in support of strengthening the
federal investment in biomedical, behavioral, social, and population-
based research conducted and supported by the National Institutes of
Health (NIH) through a recommendation of at least $46.1 billion for
NIH's base program level budget in FY 2022.
As a result of the strong, bipartisan vision of the House and
Senate Labor-HHS-Education Subcommittees over the last six years,
Congress has helped the agency regain some of the ground lost after
years of effectively flat budgets. That renewed investment in NIH has
advanced discovery toward promising therapies and diagnostics,
reenergized existing and aspiring scientists nationwide, and restored
hope for patients and their families. As the Subcommittee has
recognized, to remain a global leader in accelerating the development
of life-changing cures, pioneering treatments, and innovative
prevention strategies, and in this time of unprecedented scientific
opportunity, it is essential that Congress sustain long-term robust
increases in the NIH budget.
In FY 2022, the Ad Hoc Group for Medical Research supports at least
$46.1 billion for the NIH base program level budget, including funds
provided through the 21st Century Cures Act Innovation Fund for
targeted initiatives, a $3.2 billion increase over the NIH's program
level funding in FY 2021. This funding level, supported by nearly 400
stakeholder organizations, would provide 5% growth in the base budget
above inflation, expanding NIH's capacity to support promising science
in all disciplines. We are grateful for President Biden's enthusiasm
for medical research investments and welcome opportunities to engage
with the Congress and the Administration regarding the proposed
Advanced Research Projects Agency for Health (ARPA-H). Robust growth in
the foundational research that NIH supports will be key to this vision,
and we urge lawmakers to ensure no less than $46.1 billion for the
NIH's base and that any additional funds for ARPA-H or other targeted
initiatives supplement, rather than supplant, this core investment.
We further recommend a funding allocation for the Labor-HHS-
Education Subcommittee in FY 2022 that allows for the necessary
investment in NIH and other agencies that promote the health of our
nation. We believe that science and innovation are essential if we are
to continue to meet current and emerging health challenges, improve our
nation's physical and fiscal health, and sustain our leadership in
medical research.
In addition, we remain concerned about the lingering $16 billion
impact of the coronavirus pandemic on medical research progress in all
disease areas, and especially on the research workforce, as highlighted
by NIH Director Dr. Francis Collins' recent testimony before this
Subcommittee. The supplemental funding Congress has provided over the
last year has been instrumental in advancing research on COVID-19, with
tremendous success in the form of multiple safe and effective vaccines
to combat SARS-CoV-2 and other advances. But the pandemic has
threatened progress across numerous other areas, with particular
challenges for women, minorities, and early career investigators in the
research workforce. We continue to urge support for emergency
resources, as outlined in the RISE Act (H.R. 869/S. 289), that will
allow the NIH to rebuild the nation's strong and diverse research
workforce infrastructure and continue to invest in broad and new
research areas that will provide better health for patients in the
future.
NIH: A Partnership to Save Lives and Provide Hope. The partnership
between NIH and America's scientists, medical schools, teaching
hospitals, universities, and research institutions is a unique and
highly productive relationship, leveraging the full strength of our
nation's research enterprise to translate this knowledge into the next
generation of diagnostics, therapeutics, and cures. More than 80
percent of the NIH's budget is competitively awarded through nearly
50,000 research and training grants to more than 300,000 researchers at
over 2,500 universities and research institutions located in every
state and Washington, D.C. The federal government has an essential and
irreplaceable role in supporting medical research. No other public,
corporate or charitable entity is willing or able to provide the broad
and sustained funding for the cutting-edge basic research necessary to
yield new innovations and technologies of the future.
NIH has supported biomedical research to enhance health, lengthen
life, respond to emerging health threats, and reduce illness and
disability for more than 100 years. For patients and their families,
NIH is the ``National Institutes of Hope.'' The following are a few of
the many examples of how NIH research has contributed to improvements
in the nation's health.
--NIH-funded basic research laid the groundwork for the novel mRNA
vaccine technology used in the first two FDA approved SARS-CoV-
2 vaccines. Vaccines continue to be one of our most cost-
effective public health tools with every $1 spent on routine
childhood vaccinations estimated to save $5 in direct costs,
and $11 in broader costs to society.
--Following nearly three decades of NIH-funded research into novel
mechanisms of drug action, breakthroughs in the treatment of
depression came in 2019 with two new FDA-approved drugs--one
for treatment-resistant depression and the first ever treatment
for postpartum depression.
--In 2007, induced pluripotent stem cells (iPSC) were discovered when
adult cells were re-engineered into early non-differentiated
versions of themselves. In 2019, the National Eye Institute
launched a first-in-human clinical trial to test the safety of
a novel patient-specific iPSC therapy to treat the most common
form of Age-related Macular Degeneration, and the leading cause
of vision loss in the age 65+ population.
--NIH-supported researchers continue to work toward strategies to
better prevent, identify, and treat pain and substance use
disorders through the HEAL (Helping to End Addiction Long-term)
Initiative. HEAL aims to support research into new, non-
addictive medication and to establish public and private
partnerships to develop best practices in communities.
--Today, treatments can suppress HIV to undetectable levels, and a
20-year-old HIV-positive adult living in the U.S. who receives
these treatments is expected to live into his or her early 70s,
nearly as long as someone without HIV.
--The death rate for all cancers combined has declined in adults
since the early 1990s and since the 1970s for children. Overall
cancer death rates have dropped by 29% including a 2.2% drop
from 2016 to 2017, the largest single-year drop in cancer
mortality ever reported.
Sustaining Scientific Momentum Requires Sustained Funding Growth.
The leadership and staff at NIH and its Institutes and Centers have
engaged the broader community to identify emerging research
opportunities and urgent health needs and to prioritize precious
federal dollars to areas demonstrating the greatest promise. Sustained
robust increases in NIH funding are needed if we are to continue to
take full advantage of these opportunities to accelerate the
development of pioneering treatments and innovative prevention
strategies.
One long-lasting potential impact of investments in NIH is on the
next generation of scientists. Sustained increases in NIH funding over
the last six years have allowed NIH to more than double the investment
in early stage investigators (ESIs). In 2015, NIH only funded about 600
grants for ESIs and the career outlook for early career researchers
seemed grim. In FY 2020, NIH was able to fund more than 1,400 grants
for ESIs, reinvigorating the spirits of researchers in the biomedical
workforce. Sustained increases are needed to allow NIH to continue
support of new talent and innovation in medical research.
Even with recent investments in NIH, nearly 4 of every 5 research
ideas that are proposed to NIH every year cannot be funded. Additional
funding is needed if we are to strengthen our nation's research
capacity, ensure a medical research workforce that reflects the racial
and gender diversity of our citizenry, and inspire a passion for
science in current and future generations of researchers.
NIH is Critical to U.S. Competitiveness. Our country still has the
most robust medical research capacity in the world; however, other
countries have significantly increased their investment in biomedical
science, which leaves us vulnerable to the risk that talented medical
researchers from all over the world may return to better opportunities
in their home countries. We cannot afford to lose that intellectual
capacity, much less the jobs and industries fueled by medical research.
The U.S. has been the global leader in medical research because of
Congress's bipartisan recognition of NIH's critical role. To continue
our dominance, we must reaffirm this commitment to provide NIH the
funds needed to maintain our competitive edge.
NIH: An Answer to Challenging Times. Research supported by NIH
drives local and national economic activity, creating skilled, high-
paying jobs and fostering new products and industries, and catalyzes
increases in private sector investment. A $1 increase in public basic
research stimulates an additional $8.38 investment from the private
sector after eight years. A $1 increase in public clinical research
stimulates an additional $2.35 in private sector investments after
three years. According to a United for Medical Research report, in FY
2020, NIH-funded research supported more than 536,000 jobs across the
U.S. and generated more than $91 billion in economic activity.
The Ad Hoc Group's members recognize the tremendous challenges
facing our nation and acknowledge the difficult decisions that must be
made to restore our country's fiscal health. Robust funding of the NIH,
and strengthening our commitment to medical research, is a critical
element in ensuring the health and well-being of the American people
and our economy. Therefore, for FY 2022, the Ad Hoc Group for Medical
Research recommends that NIH receive at least $46.1 billion in base
funding to advance the foundational research NIH supports and continue
the momentum in our nation's investment in medical research.
______
Prepared Statement of The AIDS Institute
Dear Chairwoman Murray and Members of the Subcommittee:
The AIDS Institute, a national public policy, research, advocacy,
and education organization, is pleased to offer testimony in support of
domestic HIV and hepatitis programs in the FY2022 Labor, Health and
Human Services, Education, and Related Agencies (L-HHS) appropriation
measure. This year's L-HHS bill is more important than ever, as it will
set up critical funding streams to help rebuild and reinvest in our
nation's public health infrastructure, which has been decimated by
COVID-19. As you craft the FY2022 L-HHS appropriations bill, we urge
you to significantly increase funding for the Ending the HIV Epidemic
Initiative, as well as appropriate additional funds for core public
health programs that work to treat and prevent HIV and viral hepatitis
in the United States. These programs, many of which are a part of the
safety net health system, will be key tools in recovering from COVID-
19, and ensuring those most impacted by the COVID pandemic's economic
fallout can still access critical care.
hiv in the united states
Approximately 1.2 million people are living with HIV in the U.S.
Since the height of the epidemic, there have been tremendous
advancements in HIV treatment and prevention. A person living with HIV
on treatment can expect to live a near full life, and if they achieve
an undetectable viral load, are unable to pass HIV on to a partner. The
toolbox for HIV prevention is ever expanding, with pre-exposure
prophylaxis (PrEP) being the newest tool that couples with traditional
prevention techniques like condoms and syringe service programs.
Despite these advancements, new cases of HIV have been stagnant at
around 38,000 cases a year since 2013. Over the last year, COVID-19 has
severely impacted HIV prevention and treatment programs, many of which
have had to reduce services, suspend in-person testing, transition to
telehealth, and detail staff to COVID response. These programs have
been forced to innovate during COVID, and we hope some of the lessons
learned can be sustained after the pandemic has ended, such as
expansion of at-home HIV testing and increased utilization of
telemedicine for HIV treatment and PrEP expansion. It is extremely
important that additional funding goes to these programs this year so
that we can again start reducing new HIV infections while allowing
programs to refocus on core HIV prevention and treatment programs that
are vital to making progress against this epidemic.
Additionally, we believe that ending HIV is a racial justice issue.
Three quarters of new HIV infections are among people of color because
of racism and structural barriers in the healthcare system. To end HIV,
these barriers must be broken down, and we believe people living with
HIV and the communities they live in must be the drivers behind
eliminating racism in healthcare.
ending the hiv epidemic initiative
The Ending the HIV Epidemic Initiative (EHE), which began in 2019,
is focused on reducing new HIV infections by 90 percent over ten years.
In the last two years, your Committee provided $260 million and $404
million respectively for the EHE Initiative, which is run by the CDC,
the Health Resources and Services Administration (HRSA), and the
National Institutes of Health (NIH). The resources were focused on 57
jurisdictions with the greatest share of HIV incidence, enabling these
jurisdictions to craft and implement community-specific plans to reduce
the spread of HIV. HRSA's EHE funding for Community Health Centers has
already shown promising results, with more than 10,000 new clients
being treated for HIV, nearly 865,000 HIV tests administered, and
63,000 new PrEP prescriptions for people at risk for HIV. With greater
funding and continued commitment from the Biden Administration to grow
the EHE Initiative, The AIDS Institute believes this nation can make
significant progress toward the goal of ending the HIV epidemic.
We urge you to fund year three of the EHE Initiative at the
following levels: $371 million for the CDC Division of HIV/AIDS
Prevention to conduct targeted testing, connection to treatment, and
robust surveillance; $212 million for the Ryan White HIV/AIDS Program
to increase access to high-quality HIV care and treatment; $152 million
for HRSA's Community Health Center program to provide prevention
services emphasizing PrEP; $16 million for NIH's Centers for AIDS
Research to provide best practices to guide the plan; and $27 million
for the Indian Health Service to provide HIV prevention, treatment,
education, and hepatitis C (HCV) elimination in Indian Country. In
order for jurisdictions to better plan for years four through ten of
the Initiative, we urge the Committee to work with HHS, OMB and the
White House Office of HIV/AIDS Policy to make public out-year funding
projections for appropriations needed to accomplish the goals of the
Initiative by 2030.
cdc hiv prevention
CDC's Division of HIV/AIDS Prevention focuses resources on those
populations and communities most affected by investing in high-impact
prevention. One in seven people living with HIV in the United States
are unaware of their status, so it is critical that HIV testing and
prevention programs are in place to help connect people to care. There
is no single way to prevent HIV, but jurisdictions use a combination of
effective evidence-based approaches including testing, linkage to care,
education, condoms, syringe service programs, and PrEP. We urge the
Subcommittee to fund CDC's HIV Prevention program at $1.293 billion,
which includes $100 million for school-based HIV prevention efforts and
$371 million for the Ending the HIV Epidemic Plan.
the ryan white hiv/aids program
The Ryan White HIV/AIDS Program provides medications, medical care,
and essential coverage completion services to almost half of all people
living with HIV in the United States, many of whom are uninsured or
underinsured. The Ryan White Program successfully engages individuals
in care and treatment, increases access to HIV medications, and helps
over 88 percent of clients achieve viral suppression (which is critical
for HIV prevention, because people who have achieved viral suppression
cannot transmit HIV to others). Increased funding is required in FY2022
because COVID-19 has strained and will continue to strain Ryan White
programs, which have had to respond to increased demand from people
living with HIV who lost their jobs and their health insurance because
of the pandemic.
The AIDS Institute requests that the Subcommittee fund the Ryan
White HIV/AIDS Program at a total of $2.776 billion in FY2022,
distributed in the following manner: Part A at $686.7 million; Part B
(Care) at $444.7 million; Part B (ADAP) at $943.3 million; Part C at
$225.1 million; Part D at $85 million; Part F/AETC at $35.5 million;
Part F/Dental at $18 million; and Part F/SPNS at $34 million; Ending
the HIV Epidemic Plan at $212 million.
minority aids initiative
As racial and ethnic minorities in the U.S. are disproportionately
impacted by HIV/AIDS, it is critical that the Subcommittee continue to
fund the Minority HIV/AIDS Fund and Minority AIDS programs at SAMHSA.
We urge the Subcommittee to appropriate $105 million for the Minority
HIV/AIDS Fund; and $160 million for SAMHSA's Minority AIDS Initiative
Program.
viral hepatitis in the u.s
There has been significant increase in the number of new cases of
hepatitis A (HAV), hepatitis B (HBV), and hepatitis C (HCV) in the U.S.
over the past decade, despite medical advances that make preventing and
treating viral hepatitis more effective. There are highly effective
vaccines for both HAV and HBV, yet cases of HAV have increased 1,300
percent since 2015 and the number of new cases of HBV have remained
stable for the past decade. There are several curative treatments for
HCV, yet the number of new HCV cases has increased by 484 percent over
the past decade with no signs of slowing. The increased incidence of
viral hepatitis is largely due to increased injection drug use related
to the opioid epidemic. Moreover, the CDC estimates that as many as
half of the people who are living with chronic HBV and HCV (400,000 and
1.2 million people respectively) may be unaware that they have
contracted the conditions. Left untreated, viral hepatitis causes liver
damage, liver disease, cancer, and death. It also contributes to or
exacerbates other serious and chronic conditions, increasing health
care costs. We also expect to see even greater increases in viral
hepatitis cases when data become available for 2020, as we know that
many state public health systems were unable to maintain outreach,
testing, and treatment services for viral hepatitis while also battling
COVID-19, and many harm reduction programs were also unable to operate
at full capacity during the pandemic. We can eliminate viral hepatitis,
but doing so will require substantially increased investment in the
public health infrastructure for prevention, screening, and treatment.
infectious disease impact of the opioid crisis
The recent explosion of opioid use has created tremendous risk for
viral hepatitis and HIV outbreaks and increasing infection rates among
new groups and undoing progress toward curbing transmissions. The
COVID-19 pandemic has caused another surge in injection drug use, with
2020 poised to have the highest overdose death total on record. The
systems built to respond to HIV and viral hepatitis are well poised to
conduct outreach, engagement, and early intervention services with
individuals who use drugs. A comprehensive response to the opioid
epidemic must include infectious disease prevention efforts to reduce
the infectious disease consequences of the epidemic.
Starting in FY19, Congress allocated new funding to surveil,
prevent and treat infectious diseases commonly associated with
injection drug use, including viral hepatitis and HIV. We urge the
Subcommittee to appropriate $120 million for the CDC's infectious
diseases and opioid epidemic efforts.
cdc viral hepatitis prevention
The CDC's Viral Hepatitis program funding level is only $39.5
million, which is not nearly sufficient to address the increasing scope
of the epidemic. In 2016, the agency suggested it would need 10 times
that amount annually to establish a comprehensive national program to
effectively combat the spread of viral hepatitis. This year, we request
that the Subcommittee appropriate $134 million to the CDC to address
the rise in viral hepatitis and combat the impact of the opioid crisis.
syringe service programs
Syringe service programs (SSPs) are a critical tool in the fight to
end the opioid epidemic and eliminate viral hepatitis. These important
public safety programs reduce the spread of infectious disease, prevent
overdose deaths, and connect clients to treatment. The presence of SSPs
has been associated with a 50 percent decline in new HIV and viral
hepatitis incidence, and when combined with medication-assisted
treatment, there is a two-thirds reduction in HIV and HCV transmission.
Extensive research shows that these programs save money and that they
do not increase drug use. But there are not enough SSPs to meet the
growing need, and appropriations language prohibiting them from using
federal funds to purchase sterile syringes makes it difficult for many
programs to meet their biggest expense. We urge your Subcommittee to
increase funding for SSPs and to remove all restrictions on federal
funding for syringe service programs, including for the purchase of
sterile syringes. The President's FY22 Budget Request and the House's
FY21 appropriations bill both removed the restrictions for the purchase
of sterile syringes.
public health infrastructure
Decades of chronic underfunding of public health infrastructure
programs have left the United States extremely vulnerable to public
health disasters, as evidenced by the untold physical and economic harm
COVID-19 has wrought on our nation, with more than 33 million Americans
sickened and over 600,000 deaths to date. Pandemics are a threat to our
nation's safety and health, and we urge the Committee to fund public
health programs with the same priority as traditional defense programs.
Billions in increased funding is needed annually to ensure that public
health programs are modernized, fully staffed, and prepared for public
health emergencies. Yearly appropriations have fallen far short of what
is needed to protect America's health, which has allowed emerging
threats like COVID-19 to wreak havoc.
The AIDS Institute thanks Chairwoman Murray for reintroducing the
Public Health Infrastructure Saves Lives Act (S.674), which would
create the Core Public Health Infrastructure Program withing the CDC.
We believe that this program, if fully funded, will start to rebuild
and bolster critical infrastructure needed to prepare for the next
public health threat. We thank the Committee and your colleagues for
significant increases in emergency funding approved during COVID-19,
but we also urge you to ensure that this funding is sustained to
forestall future emergencies. We urge the Committee Members and your
colleagues to support S. 674, and once signed into law, ensure that the
authorized programs are fully funded by your Committee.
Thank you for your consideration of this written testimony. If you
have questions or would like to discuss these issues further, please do
not hesitate to contact Nick Armstrong at [email protected] or
Frank Hood at [email protected].
[This statement was submitted by Rachel Klein, Deputy Executive
Director, The AIDS Institute.]
______
Prepared Statement of AIDS United
Dear Chairman Leahy, and Vice Chairman Shelby:
As the committee continues its important deliberations on the
Fiscal Year (FY) 2022 Labor, Health and Human Services, Education, and
Related Agencies (Labor-HHS) appropriation bill, we thank you for your
commitment to ending the HIV/AIDS epidemic in the United States and
request that you increase the federal government's financial commitment
to meet the goals of the federal ending the epidemic initiative and
support safety net programs that protect the public health.
Our scientific knowledge of HIV treatment, prevention and
epidemiology has never been stronger, but progress, until recently, has
stalled. Over the past three years, a concerted effort to target
resources where they can be most effective has occurred through the
Ending the HIV Epidemic Initiative (EHE Initiative), which has the goal
of reducing new HIV infections by 90% by 2030. Additionally, the HIV
National Strategic Plan: A Roadmap to End the Epidemic has been
developed. We urge Congress to capitalize on the expertise developed by
communities as part of the EHE Initiative so that we can improve and
expand the Initiative. Ending HIV by 2030 is possible, but resources
are needed to achieve this goal.
The COVID-19 pandemic has shown a light on the impact of decades of
underfunding our Nation's public health infrastructure, resulting in an
inadequate response to an incredibly destructive pandemic. Below are
detailed domestic HIV funding requests that we join our coalition
partners in the Federal AIDS Policy Partnership in urging committee to
include in the FY2022 appropriations bills. A chart detailing each
request as well as previous fiscal year funding levels for each program
is available here: http://federalaidspolicy.org/fy-abac-chart/.
ending the hiv epidemic initiative
Over the last two years, on a bipartisan basis, Congress has
appropriated additional funding for the Ending the HIV Epidemic
Initiative, which sets the goal of reducing new HIV infections by 50%
by 2025, and 90% by 2030. We ask Congress to increase funding in FY2022
for the Ending the HIV Epidemic Initiative by at least the amounts
listed below in the following operating divisions:
--CDC Division of HIV/AIDS Prevention for testing, linkage to care,
and prevention services, including pre-exposure prophylaxis
(PrEP) (+$196 m);
--HRSA Ryan White HIV/AIDS Program to expand comprehensive treatment
for people living with HIV (+$107 m);
--HRSA Community Health Centers to increase clinical access to
prevention services, particularly PrEP (+$34.7 m);
--The Indian Health Service (IHS) to address the combat the disparate
impact of HIV on American Indian/Alaska Native populations
(+$22 m); and
--NIH Centers for AIDS Research to expand research on implementation
science and best practices in HIV prevention and treatment.
the ryan white hiv/aids program
The Ryan White Program provides comprehensive care to populations
disproportionately impacted by the HIV epidemic. Over three quarters of
Ryan White clients are racial and ethnic minorities, and nearly two
thirds are under the federal poverty level. With 88% of Ryan White
clients achieving viral suppression, the program has a proven track
record of success.
The Ryan White Program provides services critical to managing HIV,
often inadequately covered by insurance, including case management;
mental health and substance use services; adult dental services; and
transportation, legal, and nutritional support services. Many Ryan
White Program clients live in states that have not expanded Medicaid
and must rely on the Ryan White Program as their only source of HIV/
AIDS care and treatment. While increasingly clients have access to
insurance, patients still experience cost barriers, such as high
premiums, deductibles, and other patient cost sharing. The Ryan White
Program, particularly the AIDS Drug Assistance Program (ADAP), assists
with these costs so that clients can access comprehensive treatment.
Currently ADAPs are experiencing increased demand, particularly as
people have lost health coverage and incomes due to the economic impact
of COVID-19 and state and local budgets have been increasingly
stressed. We urge Congress to fund the Ryan White HIV/AIDS Program at a
total of $2.768 billion in FY2022, an increase of $345 million over
FY2021, distributed in the following manner:
--Part A: $731.1 million
--Part B (Care): $437 million
--Part B (ADAP): $968.3 million
--Part C: $225.1 million
--Part D: $85 million
--Part F/AETC: $58 million
--Part F/Dental: $18 million
--Part F/SPNS: $34 million
--EHE Initiative: $212 million
cdc prevention programs
CDC HIV Prevention and Surveillance
Increasing funding for high-impact, community focused HIV
prevention services has proven to result in a strong return on
investment. Not only are these prevention tools effective at halting
new HIV infections, but in the long term they result in decreased
lifetime medical costs that are associated with HIV treatment. HIV
prevention tools that meet the special prevention needs of these
populations must be expanded. HIV will not be eliminated unless we
focus resources on those most impacted.
The CDC's Division of HIV Prevention is the federal leader in
creating new and innovative strategies for HIV prevention. Through
partnerships with state and local public health departments and
community-based organizations, the CDC has expanded targeted, high-
impact prevention programs that work to address racial and geographic
health disparities. We urge you to fund the CDC Division of HIV
Prevention at $822.7 million in FY2022, an increase of $67 million over
FY2021. This is in addition to the $371 million for EHE Initiative work
within the Division.
CDC STD Prevention
Our nation faces a compounded public health crisis. STI rates are
at an all-time high for the sixth year in a row. STI data from 2018
shows that combined cases of chlamydia, gonorrhea, and syphilis
infections are nearing 2.4 million cases a year--up 30%. STIs have
life-changing and life-threatening consequences that include
infertility, cancer, ectopic pregnancy, pelvic inflammatory disease,
and transmission of HIV. More than 17 years of level funding for STI
programs has resulted in a more than 40% reduction in buying power. The
STI health infrastructure is part of the public health infrastructure
and the need to rebuild is higher than ever. While STI rates peak, the
same people who work to prevent the spread of sexually transmitted
diseases--contact tracers and disease intervention specialists--have
been redeployed to address the current COVID-19 pandemic. Consequently,
80% of sexual health screening clinics being forced to reduce hours or
shut down because of understaffing. We urge you to fund the CDC
Division of STD Prevention at $252.9 million to rebuild its
infrastructure and respond to the dramatic rise in STIs across the
country.
Congenital Syphilis is a fully preventable disease if women are
provided early, accessible prenatal care that includes STI testing.
Despite this, the transmission of congenital syphilis from mother to
child during birth increased by 185% between 2014-2018 with an increase
more than 40% between 2017 and 2018 alone. The result: a 22% increase
in newborn deaths. Twenty million dollars should be allocated to
activate a new congenital syphilis elimination initiative at the CDC
Division of STD Prevention (DSTDP)--with funds distributed to all STI-
funded health departments--to increase prenatal outreach and screenings
for congenital syphilis and postnatal follow up for both mothers and
babies to ensure that congenital syphilis is detected at the earliest
possible stage. We urge you to fund the CDC Division of STD Prevention
at $272.9 million in FY2022, an increase of $91.1 million over FY2021.
CDC Viral Hepatitis Prevention
The ongoing opioid crisis and increased injection drug has
drastically increased the number of new viral hepatitis cases in the
U.S. The CDC estimates that between 2010 and 2017 the country
experienced a 374% increase in new hepatitis C (HCV) infections, with
an estimated 44,600 new cases in 2017. The number of new cases of
hepatitis B (HBV) has also increased over the past several years, with
22,200 new cases in 2017, ending years of declining rates. Of the more
than 3.2 million people now living with HBV and/or HCV in the U.S., as
many as 65% are not aware of their infection.
The CDC's Division of Viral Hepatitis (DVH) remains the lead agency
combating viral hepatitis at the national level by providing important
information and funding to the states. The division is currently funded
at only $39.5 million. This is nowhere near the nearly $393 million CDC
estimates is needed for a national viral hepatitis program focused on
decreasing mortality and reducing the spread of the disease. We have
the tools to prevent this growing epidemic and the Viral Hepatitis
National Strategic Plan for the United States: A Roadmap to Elimination
(2021--2025). However, only with significantly increased funding can
there be an adequate level of testing, education, screening, treatment,
surveillance, and on-the-ground syringe service programs needed to
reduce new infections and put the U.S. on the path to eliminate
hepatitis as a public health threat. We urge you to fund the CDC's
Division of Viral Hepatitis at $134 million in FY2022, an increase of
$94.5 million over FY2021.
CDC Infectious Diseases and Opioid Epidemic Funding
The FY2019 budget included new funding for the CDC to combat
infectious diseases commonly associated with injection drug use in
areas most impacted by the opioid crisis. The United States is
experiencing an ongoing overdose crisis and some experts have estimated
that the U.S. surpassed 100,000 deaths from opioid overdose in 2020, a
more than 40% increase from 2019 itself a record year. Outbreaks or
significant spikes in infections of viral hepatitis, as well as HIV, in
a short period of time among people who inject drugs continue to occur
throughout the country. Syringe Services Providers (SSPs) are first
responders to the opioid and infectious diseases crisis effectively
help prevent drug overdoses and new HIV and hepatitis infections. They
have the knowledge, contacts, and ability to reach people who use
drugs; they provide naloxone and other overdose prevention resources;
and they connect people to medical care and support, including
Substance Use Disorder treatment. This program, which is only funded at
$13 million, increases prevention, testing, and linkage to care efforts
to combat increasing new infections and is strongly needed to provide a
strong on the ground response to this crisis. These services are
urgently needed, and adequate funding would provide a critical down
payment for services needed to help stop the spread of opioid-related
infectious diseases. We urge you to fund the CDC's Infectious Diseases
and Opioid Epidemic program in FY2022 at the $120 million requested in
the president's FY2021 budget, an increase of $107 million over FY2021.
Syringe Services Programs
The Department of Health and Human Services has said that syringe
service programs (SSPs) are a proven, evidence-based, and effective
tool in HIV and hepatitis prevention. Beyond providing access to
sterile syringes, SSPs connect people to substance use treatment, HIV
and hepatitis testing, and other supportive services. These cost-
effective programs must be expanded, especially in areas hardest hit by
the opioid epidemic. SSPs have also been providing COVID-19 related
services to vulnerable populations during the pandemic. The FY2021
appropriations bill continued a harmful policy rider that restricts the
use of federal funds for the purchase of sterile syringes, which
negatively impacts the ability of state and local public health groups
from expanding SSPs. We urge you to remove all restrictions on federal
funding for syringe service programs in those jurisdictions that are
experiencing or at risk for a significant increase in HIV or hepatitis
infections due to injection drug use.
Minority HIV/AIDS Initiative (MAI)
Racial and ethnic minorities in the U.S. are disproportionately
impacted by HIV/AIDS. African Americans, more than any other racial/
ethnic group, continue to bear the greatest burden of HIV in the U.S.
Three out of four new HIV infections occur among people of color. While
there have been consistent decreases in new HIV infections among
certain populations, HIV infections are not decreasing among Black and
Latinx gay and bisexual men.
The Minority HIV/AIDS Fund supports cross-agency demonstration
initiatives to support HIV prevention, care and treatment, and outreach
and education activities across the federal government. MAI programs at
the Substance Abuse and Mental Health Administration target specific
populations and provide prevention, treatment, and recovery support
services, along with HIV testing and linkage service when appropriate,
for people at risk of mental illness and/or substance abuse. We urge
you fund the Minority HIV/AIDS Fund at $105 million, and SAMHSA's MAI
program at $160 million in FY2022, an increase of $49.6 million and $44
million over FY2021 levels, respectively. We also urge you to fund
Minority AIDS Initiative programs across HHS agencies at $610 million
in FY2022.
We thank you for your continued leadership and support of these
critical programs for so many people living with HIV, and the
organizations and communities that serve them nationwide.
Please do not hesitate to be in touch for more information
regarding HIV appropriations with our Vice President and Chief Advocacy
Officer, Carl Baloney, Jr., at [email protected].
Sincerely.
[This statement was submitted by Jesse Milan, Jr., President & CEO,
AIDS United.]
______
Prepared Statement of the Alzheimer's Association and Alzheimer's
Impact Movement
The Alzheimer's Association and Alzheimer's Impact Movement (AIM)
appreciate the opportunity to submit outside witness testimony on the
Fiscal Year (FY) 2022 appropriations for Alzheimer's and other dementia
research and public health activities at the U.S. Department of Health
and Human Services. Specifically, we respectfully request a $289
million increase for Alzheimer's research at the National Institutes of
Health (NIH) and $20 million for implementation of the Building Our
Largest Dementia (BOLD) Infrastructure for Alzheimer's Act (P.L. 115-
406) at the Centers for Disease Control and Prevention (CDC).
The Alzheimer's Association is the world's leading voluntary health
organization in Alzheimer's care, support, and research. It is the
nonprofit with the highest impact in Alzheimer's research worldwide and
is committed to accelerating research toward methods of treatment,
prevention, and, ultimately, a cure. AIM is the advocacy affiliate of
the Alzheimer's Association, working in strategic partnership to make
Alzheimer's a national priority. Together, the Alzheimer's Association
and AIM advocate for policies to fight Alzheimer's disease, including
increased investment in research, improved care and support, and
development of approaches to reduce the risk of developing dementia.
alzheimer's impact on american families and the economy
Alzheimer's is a progressive brain disorder that damages and
eventually destroys brain cells, leading to a loss of memory, thinking,
and other brain functions. Ultimately, Alzheimer's is fatal. We have
yet to celebrate the first survivor of this devastating disease.
In addition to the suffering caused by the disease, Alzheimer's is
also creating an enormous strain on the health care system, families,
and federal and state budgets. The annual cost for all individuals with
Alzheimer's or other dementia will total $355 billion for health care,
long-term care, and hospice care in 2021. This does not include the
over $250 billion in unpaid caregiver costs. The U.S. taxpayer-funded
federal health care programs Medicare and Medicaid are expected to
cover about $239 billion, or 67 percent, of these costs this year.
While an estimated 6.2 million Americans age 65 and older are currently
living with Alzheimer's, nearly 13 million Americans will have
Alzheimer's by 2050 and costs will exceed $1.1 trillion (in 2021
dollars). Alzheimer's and other dementia threaten to bankrupt families,
businesses, and our health care system.
investing in alzheimer's treatments
The Food and Drug Administration (FDA) recently approved the first
treatment for Alzheimer's disease since 2003 and the first to address
the underlying biology of Alzheimer's disease. The FDA determined there
is substantial evidence that aducanumab (marketed as Aduhelm) reduces
amyloid plaques in the brain and that the reduction in these plaques is
reasonably likely to predict important benefits to patients.
This approval represents an important step forward in Alzheimer's
research. This new treatment is pivotal, while not a cure. This is the
first of a number of new treatments to come. We recognize the drug may
work differently for everyone who takes it, and may not work for some
individuals. Importantly, aducanumab was studied in and appropriate for
people living with early Alzheimer's dementia and mild cognitive
impairment (MCI) due to Alzheimer's who showed evidence of a buildup of
amyloid plaques in the brain. The therapy has not yet been tested on
people with more advanced cases of dementia or Alzheimer's disease.
The recent years of increased investment provided by Congress to
NIH have been integral to this and other promising therapeutic
approaches to treating Alzheimer's disease. For example, NIH supported
basic science investigations behind the discovery of immunotherapies
like aducanumab, as well as translational research for next-generation
immunotherapies. Additionally, the selection of participants for
aducanumab clinical trials hinged on amyloid PET imaging, a technology
that would not exist today without the publicly-funded research
supported by NIH. The federal commitment, combined with unprecedented
philanthropic support, provides the foundation for an optimistic view
of the future, which is needed because there is much work to be done.
This is just the beginning of meaningful treatment advances.
History has shown us that approvals of the first drug in a new category
invigorates the field, increases investments in new treatments, and
encourages greater innovation. We are hopeful that this drug is just
the beginning for better treatments to come. Looking at the big picture
of science, there is a crucial need for effective treatment options for
diverse populations living in all stages of Alzheimer's. Alzheimer's
must be addressed through multiple different pathways--more than just
amyloid--with an eye toward effective combination therapies,
pharmacological and nonpharmacological, that work at different stages
of the disease.
While recent NIH funding increases have laid the foundation for
breakthroughs in diagnosis, treatment, and prevention, and enabled
significant advances in understanding the complexities of Alzheimer's,
there is still much left to be done. We cannot leave any stone
unturned. Investment in Alzheimer's research is only a fraction of
what's been applied over time, with great success, to address other
major diseases. Between 2000 and 2017, the number of people dying from
Alzheimer's increased by 145 percent while deaths from other major
diseases have decreased significantly or remained approximately the
same. It is vitally important that NIH continues to build upon
promising research advances. An increase of $289 million in Alzheimer's
research at NIH in FY2022 would enable scientists to conduct more
inclusive, efficient, and practical clinical trials; increase knowledge
of risk and protective factors in individuals and across diverse
populations; discover better biomarkers to detect disease and monitor
treatment response; pursue a precision medicine approach to detect the
disease earlier and tailor treatment plans to an individual's unique
symptoms and risk profile; and leverage emerging digital technologies
and big data to speed discoveries. We need to continue to increase
investment in Alzheimer's and dementia research to maximize every
opportunity for success.
addressing alzheimer's as a public health crisis
As scientists continue to search for ways to cure, treat, or slow
the progression of Alzheimer's through medical research, public health
plays a critical role in promoting cognitive function and reducing the
risk of cognitive decline. Now more than ever it is apparent how
crucial it is to have an established infrastructure in place to respond
to public health threats.
In 2018, Congress acted decisively to address Alzheimer's as an
urgent and growing public health threat through the passage of the
bipartisan BOLD Act. This law authorizes $100 million over five years
for CDC to build a robust Alzheimer's public health infrastructure
across the country focused on public health actions that can allow
individuals with Alzheimer's to live in their homes longer and delay
costly long-term nursing home care. Congress appropriated $10 million
for the first year of BOLD's implementation in FY20, which allowed CDC
to award funding to three Public Health Centers of Excellence (PHCOE),
focused on risk reduction, caregiving, and early detection, and 16
public health departments across the country. These state, local, and
tribal public health department recipients are creating statewide
dementia coalitions, hiring dementia coordinators, and developing or
updating Alzheimer's and other dementia strategic plans. The $15
million Congress appropriated for the second year of BOLD's
implementation in FY21 will help fund additional public health
departments and expand the impact of this crucial work into more
communities across the country.
The Alzheimer's Association is grateful to be leading the Dementia
Risk Reduction PHCOE, focusing on community-level actions to reduce the
risk of developing Alzheimer's and other dementia. Researchers are
increasingly studying the impact that lifestyle behaviors may have on
the risk of developing Alzheimer's and other dementia. The future of
reducing Alzheimer's could be in treating the whole person with a
combination of drugs and modifiable risk factor interventions, as we do
now with heart disease. The Center will work with public health
agencies on addressing social determinants of health with respect to
dementia risk; capacity building to enable smaller public health
agencies to engage in dementia risk reduction activities; and
partnering with health systems in their communities to advance risk
reduction.
Over 65 percent of American adults have at least one risk factor
for dementia. Although risk factors like age, genetics, and family
history cannot be changed, other risk factors can be modified to reduce
the risk of cognitive decline and dementia. Examples of modifiable risk
factors are physical activity, smoking, education, staying socially and
mentally active, blood pressure, and diet. In fact, the 2020
recommendations of The Lancet Commission on dementia prevention,
intervention, and care suggest that addressing modifiable risk factors
might prevent or delay up to 40 percent of dementia cases.
The Alzheimer's Association is leading a five-year clinical trial
to evaluate a two-year intervention to see whether lifestyle
interventions that simultaneously target multiple risk factors can
protect cognitive function in older adults at increased risk for
cognitive decline. The U.S. Study to Protect Brain Health Through
Lifestyle Intervention to Reduce Risk (U.S. POINTER) will evaluate the
effects of lifestyle interventions, like physical exercise, a healthier
diet, cognitive and social stimulation, and self-management of heart
and vascular health, on changes in cognitive function. It is crucial
that forthcoming findings from studies like U.S. POINTER are translated
into public health interventions across the country. Investing now in a
robust public health infrastructure ensures cutting edge research can
be effectively and efficiently disseminated into local communities.
While these BOLD implementation efforts are important steps
forward, and we are grateful to this Subcommittee and Congress for the
initial funding, CDC must receive the full $20 million authorized in
the law for FY2022 to ensure the meaningful impact that Congress
intended. The Alzheimer's Association and AIM urge Congress to include
the full $20 million for the third year of BOLD's implementation at CDC
in FY2022. Activities supported by the requested $20 million in FY22
would enable CDC to award additional PHCOEs, focused on important
priorities such as Tribal Health and avoiding preventable
hospitalizations, and expand the number of state, local, and tribal
public health departments across the country that receive funding for
Alzheimer's public health activities. Finally, as Alzheimer's is one of
the most prevalent chronic diseases facing our nation, we look forward
to the day that the Subcommittee and CDC elevate Alzheimer's and other
dementia to the Division level as with other major chronic diseases.
conclusion
The Alzheimer's Association and AIM appreciate the steadfast
support of the Subcommittee and its priority setting activities. We
urge the Subcommittee and Congress to provide an additional $289
million for Alzheimer's research activities at NIH and $20 million for
full implementation of the BOLD Infrastructure for Alzheimer's Act at
CDC in FY 2022.
______
Prepared Statement of the Alzheimer's Foundation of America
On behalf of the Alzheimer's Foundation of America (AFA), a
national nonprofit that unites more than 2,000 member organizations in
the goal of providing support, services and education to individuals,
families and caregivers affected by Alzheimer's disease and related
dementias nationwide, I am submitting the following budget requests for
your consideration as you prepare fiscal year (FY) 2022 appropriations
levels for the federal budget.
For federal programs that impact those living with dementia and
their family caregivers, AFA recommends the following budget
allocations for FY '22:
--an additional $289 million for a total $3.4 billion for Alzheimer's
disease clinical research at the National Institutes of Health/
National Institute on Aging (NIH/NIA);
--$560 million to fund the Brain Research through Advancing
Innovative Neurotechnologies (BRAIN) Initiative, a trans-agency
effort to arm researchers with revolutionary tools to
fundamentally understand the neural circuits that underlie the
healthy and diseased brain;
--$46.1 billion (a $3.2 billion increase over FY '21) for total
spending at the NIH;
--support for President Biden's call for $6.5 billion to launch the
Advanced Research Projects Agency for Health (ARPA-H) at NIH;
--an additional $50 million to fund caregiver supports and services
provided by Older Americans' Act (OAA) programs administered by
the Administration for Community Living (ACL), including a $7.5
million increase for the Alzheimer's Disease Program for a
total expenditure of $35 million in FY '22; and
--$20.5 million to support BOLD Act initiatives, including a $500,000
increase for the Healthy Brain Initiative and $4 million for
fall prevention at the Centers for Disease Control and
Prevention (CDC).
National Institutes of Health/National Institute on Aging (NIH/NIA):
NIA sponsors and conducts the lion's share of federal aging-related
research, including research into Alzheimer's disease and related
dementias, and this pioneering science contributes significantly to the
improved care and quality of life of older adults. A key NIA priority
is translating research into better and more efficient care through the
development of effective interventions that are disseminated to health
care providers, patients, and caregivers. These interventions for the
prevention, early detection, diagnosis, and treatment of disease will
help reduce the burden of illness for older adults and lower cost of
care.
AFA is extremely grateful to the Subcommittee for recent increases
in federal funding for Alzheimer's disease research at NIH/NIA.
Additional resources for fighting Alzheimer's disease and related
dementias at NIH have greatly increased our chances that promising
research gets funded as we move closer to the goal of finding a cure or
disease-modifying treatment by 2025 as articulated in the National Plan
to Address Alzheimer's Disease.
Yet, meaningful treatment is still some ways off and basic science
into dementia--the type of research funded through NIH--remains vital
to finding a cure.
AFA asks the Subcommittee to build upon past progress and continue
making the battle against Alzheimer's disease a national priority. To
this end, AFA urges the Subcommittee to provide an additional $289
million, for a total of approximately $3.4 billion for Alzheimer's
disease clinical research at NIH in FY '22.
The BRAIN Initiative is a large-scale effort to accelerate
neuroscience research by equipping researchers with the tools and
insights necessary for treating a wide variety of brain disorders,
including Alzheimer's disease, schizophrenia, autism, epilepsy, and
traumatic brain injury. By mapping whole brains in action, the ability
to identify thousands of brain cells at a time and development of
innovative brain scanners, BRAIN Initiative research advances and tools
are needed to better understand the brain and cognitive functioning.
AFA is asking that $560 million be allocated to conduct BRAIN
Initiative research for FY '22.
AFA also urges the Subcommittee to budget at least $46.1 billion
for total NIH spending in FY '22, a $3.2 billion increase over the
NIH's program level funding in FY '21, as recommended by the Ad Hoc
Group for Medical Research. This funding level would allow for
meaningful growth above inflation in the base budget that would expand
NIH's capacity to support promising science in all disciplines. It also
would ensure that funding from the Innovation Account established in
the 21st Century Cures Act would supplement the agency's base budget,
as intended, through dedicated funding for specific programs.
AFA also supports the President's call for an additional $6.5
billion to launch the Advanced ARPA-H at NIH. ARPA-H would leverage
existing public sector basic science research programs along with
private sector efforts to accelerate development of new capabilities
for disease prevention, detection, and treatment and overcome
bottlenecks that have limited progress in areas such as Alzheimer's
disease. Any funding for ARPA-H, however, should not come from the
existing programming budget for NIH and should be considered an
additional appropriation to AFA's $46.1 billion request for all of NIH.
Centers for Disease Control and Prevention (CDC):
The Building Our Largest Dementia (BOLD) Infrastructure for
Alzheimer's Act requires CDC to establish Centers of Excellence in
Public Health Practice dedicated to promoting Alzheimer's disease
management and caregiving interventions, as well as educating the
public on Alzheimer's disease and brain health, will establish
Alzheimer's disease as a public health issue, increasing American
awareness and care training around the disease. To fund BOLD Act
initiatives at CDC, AFA is requesting $20 million in funding for FY
'22.
For older adults--especially for those living with dementia--falls
are common, costly, and often preventable. They represent the leading
cause of injury-related death among adults age 65 years of age and
older. CDC's National Center for Injury Prevention and Control
developed tools for clinicians and other health care partners to
identify and address falls and fall risk. AFA urges a continued
investment of $4 million to continue funding fall prevention programs
at CDC.
Administration for Community Living (ACL):
AFA is requesting a $50 million increase for vital ACL programming
impacting those living with dementia, including a $7.5 million increase
to the Alzheimer's Disease Program for a total funding of $35 million
in FY '22. In addition, AFA is requesting that the following amounts be
allocated to the following Older Americans' Act (OAA) programs
administered by ACL:
--National Family Caregiver Support Program (NFCSP): NFCSP provides
grants to states and territories, based on their share of the
population aged 70 and over, to fund a range of supportive
services that assist family and informal caregivers in caring
for those with dementia at home for as long as possible, thus
providing a more person-friendly and cost-effective approach to
institutionalization. AFA urges that an additional $24.5
million (for a total of $213.6 million) be allocated in FY '22
to support this important program.
--Lifespan Respite Care Program (LRCP): AFA urges the Subcommittee to
allocate a minimum of $10 million--a $2.9 million increase--to
LRCP in FY '22. LRCP provides competitive grants to state
agencies working with Aging and Disability Resource Centers and
non-profit state respite coalitions and organizations to make
quality respite care available and accessible to family
caregivers regardless of age or disability.
--Falls Prevention: In response to COVID, several community-based
fall prevention interventions, supported with ACL investments,
have transitioned to a digital environment in cases where they
can safely be implemented in the home. AFA, therefore, urges
$10 million, a $5 million increase over FY '21 funding, be
allocated so ACL can continue vital fall prevention activities
at ACL.
--Home Delivered Nutrition Program: This vital program provides
grants to states for nutrition services for older people,
including many living with dementia. In addition to healthy
meals, the programs provide a range of services including being
an important link to in-home and community-based supports such
as homemaker and home-health aide services, transportation,
home repair and modification, and falls prevention programs.
AFA calls for a $10.1 million increase, or $286.3 million, for
home delivered nutrition programs in FY '22.
AFA understands that during this time of crisis, Congress is
working hard to stem fallout of both the human and fiscal toll of
COVID-19. We are grateful for your work and urge that the Subcommittee
continues making services and supports available to our nation's most
vulnerable populations--including those older Americans with chronic
conditions like Alzheimer's disease--a priority. We know that through
determination, sacrifice and resilience, Americans will rise to the
challenge and take the necessary steps to mitigate the fallout of this
public health emergency.
AFA thanks the Subcommittee for the opportunity to present our
recommendations and looks forward to working with you and your staff
through the appropriations process. Please contact me at
[email protected] or Eric Sokol, AFA's senior vice president of
public policy, at [email protected], if you have any questions or
require further information.
Sincerely.
[This statement was submitted by Charles J. Fuschillo, Jr.,
President and CEO, Alzheimer's Foundation of America.]
______
Prepared Statement of the American Academy of Allergy,
Asthma & Immunology
Chairwoman Murray, Ranking Member Blunt, and Members of the
Subcommittee, the American Academy of Allergy, Asthma, & Immunology
(AAAAI) thanks you for the opportunity to submit written testimony on
the U.S. Department of Health and Human Services (HHS) Fiscal Year (FY)
2022 appropriations bill. AAAAI respectfully requests the subcommittee
to include $12.2 million in funding for the Consortium on Food Allergy
Research (CoFAR) within the National Institute of Allergy and
Infectious Disease (NIAID) at the National Institutes of Health (NIH).
In addition, we request report language reflecting the importance of
NIH engaging in trans-NIH research on food allergies. Also, the AAAAI
supports funding of $100 million for the National Healthcare Safety
Network which enables the Centers for Disease Control and Prevention
(CDC) to target prevention of healthcare acquired and antimicrobial
resistant infections and improve antibiotic prescribing.
Established in 1943, AAAAI is a professional organization with more
than 7,000 members in the United States, Canada, and 72 other
countries. This membership includes board certified allergist/
immunologists, other medical specialists, allied health and related
healthcare professionals--all with a special interest in the research
and treatment of patients with allergic and immunological diseases.
food allergies
Food allergies affect 32 million Americans, including 6 million
children. Each year, more than 200,000 Americans require emergency
medical care for allergic reactions to food--equivalent to one trip to
the emergency room every three minutes.
The Consortium on Food Allergy Research (CoFAR) was established by
the National Institutes of Health (NIH) within the National Institute
of Allergy and Infectious Disease (NIAID) in 2005. Over the following
16 years, CoFAR discovered genes associated with an increased risk for
peanut allergy and has also identified the most promising potential
treatments for egg and peanut immunotherapy, among many other
accomplishments. Breakthroughs like these, scaled across other major
food allergies, can significantly improve the quality of life for tens
of millions of Americans. Its annual $6.1 million budget is a
relatively small portion within NIH's almost $40 billion budget, yet
CoFAR has been able to achieve massive strides in the study of food
allergy prevention and treatment.
AAAAI enthusiastically supports an increase in funding for CoFAR of
$6.1 million, annually, bringing its yearly budget up to $12.2 million.
With its relatively low current level of funding, CoFAR has been able
to accomplish breakthroughs in the under-researched field of food
allergies. It is crucial that we continue investing at proportional
levels given the scale of this condition which impacts 10.8 percent of
the U.S. population.
AAAAI also requests that the Subcommittee's report accompanying the
FY22 Labor/HHS appropriation reflects the importance of trans-NIH
research on food allergies. AAAAI strongly supports the following NIAID
report language submitted by Senator Blumenthal that acknowledges the
groundbreaking work of CoFAR and encourages robust investment to expand
its research breadth and network.
Food Allergies.--The Committee recognizes the serious issue of food
allergies which affect approximately eight percent of children
and ten percent of adults in the U.S. The Committee commends
the ongoing work of NIAID in supporting a total of 17 clinical
sites for this critical research, including seven sites as part
of the Consortium of Food Allergy Research (CoFAR). The
Committee includes $12,200,000, an increase of $6,100,000, for
CoFAR to expand its clinical research network to add new
centers of excellence in food allergy clinical care and to
select such centers from those with a proven expertise in food
allergy research.
In addition to the AAAAI, the CoFAR funding request and report
language are supported by the American College of Allergy, Asthma &
Immunology; Allergy & Asthma Network; Asthma and Allergy Foundation of
America; Food Allergy & Anaphylaxis Connection Team; Food Allergy
Research and Education; and International FPIES Association.
antimicrobial resistance (amr) and penicillin allergy
The growing threat of antimicrobial resistance, combined with the
dwindling pipeline of novel antibiotic research, requires policies that
prevent inappropriate use of antibiotics. One of the primary ways to
combat this threat begins with penicillin--the most commonly reported
drug allergy. According to the CDC, approximately 10 percent of the
U.S. population report being allergic to penicillin, yet 9 out of 10
patients reporting a penicillin allergy are not truly allergic when
formally evaluated, such that fewer than one percent of the population
is truly allergic to penicillin. More recently, the CDC cited the
importance of correctly identifying if patients are penicillin-allergic
in decreasing the unnecessary use of broad-spectrum antibiotics in its
2018 update of Antibiotic Use in the United States: Progress and
Opportunities. The AAAAI strongly supports more widespread and routine
use of penicillin allergy evaluation for patients with a self-reported
history of allergy to penicillin. Evaluation can accurately identify
patients who, despite reporting a history of penicillin allergy, can
safely receive penicillin.
The AAAAI supports funding of $100 million for the National
Healthcare Safety Network which enables CDC to target prevention of
healthcare acquired and antimicrobial resistant infections and improve
antibiotic prescribing. The Antibiotic Resistance Solutions Initiative
will benefit from significant new resources to achieve the goals
outlined in the National Action Plan for Combating Antibiotic-Resistant
Bacteria, including strengthening antibiotic stewardship to promote
best practices for prescribing antibiotics such as penicillin.
AAAAI also wishes to express its appreciation to the subcommittee
for the inclusion of language regarding the importance of penicillin
allergy testing in the FY20 appropriations bill. The discovery of
penicillin opened the door to medical innovation allowing surgeries to
be performed, organs to be transplanted, as well as combat wounds and
burn victims to be treated. AAAAI encourages more widespread and
routine penicillin allergy evaluation for patients with a history of
allergy to penicillin or another beta-lactam drug (e.g., ampicillin or
amoxicillin). Penicillin allergy evaluation can accurately identify
patients who, despite reporting a history of penicillin allergy, can
safely receive penicillin. On behalf of the patients we serve, thank
you for your leadership in giving penicillin allergy testing the
attention it deserves.
Thank you for your consideration of these FY22 appropriations
requests. Please contact Sheila Heitzig, JD, MNM, CAE, AAAAI Director
of Practice and Policy, at [email protected] if you have any questions
or would like additional information.
______
Prepared Statement of the American Academy of Pediatrics
The American Academy of Pediatrics (AAP), a non-profit professional
organization of 67,000 primary care pediatricians, pediatric medical
subspecialists, and pediatric surgical specialists dedicated to the
health, safety, and well-being of infants, children, adolescents, and
young adults, appreciates the opportunity to submit this statement for
the record in support of strong federal investments in children's
health in Fiscal Year (FY) 2022 and beyond.
AAP urges all Members of Congress to put children first when
considering short and long-term federal spending decisions, and
supports funding levels for the following programs: $50 million for
Pediatric Subspecialty Loan Repayment (HRSA), $50 million for Firearm
Injury and Mortality Prevention Research (CDC/NIH), $10 million for
Pediatric Mental Health Care Access Grants (HRSA), $12 million for
implementation of Scarlett's Sunshine Act (CDC/HRSA), $22.334 million
for Emergency Medical Services for Children (HRSA), $280 million for
the National Center for Birth Defects and Developmental Disabilities
(CDC), $271.2 million for Global Immunizations (CDC), and $15 million
and report language for the Vaccine Awareness Campaign to Champion
Immunization Nationally and Enhance Safety (VACCINES) Act (CDC).
Pediatric Subspecialty Loan Repayment Program (HRSA):
FY 22 Request: $50 Million; FY 21 Level: Never Funded.--The AAP
requests $50 million in initial funding for the Pediatric Subspecialty
Loan Repayment Program, a Title VII health professions program to
improve access to care for children with special health care needs by
offering loan repayment to pediatric subspecialists and child mental
health providers who agree to serve in an underserved area. The United
States' supply of pediatric subspecialists is inadequate to meet
children's health needs. Many children must wait more than 3 months for
an appointment with a pediatric subspecialist, and approximately 1 in 3
children must travel 40 miles or more to receive care from a
pediatrician certified in certain subspecialties such as developmental
behavioral pediatrics. Spotlighting the needs of children with autism
spectrum disorder (ASD), as an example, there are approximately 1.5
million children with ASD but there are only about 700 practicing
board-certified developmental-behavioral pediatricians. The national
wait time for a pediatric developmental evaluation is 5.4 months. In
terms of equity, ASD prevalence among Hispanic children is about 16%
lower than among white and black children, which suggests that more
Hispanic children with autism are not being identified. In addition,
black children with ASD are significantly less likely than white
children to have a first evaluation by the age of three.
Firearm Injury and Mortality Prevention Research (CDC/NIH):
FY 22 Request: $50 Million Total; FY 21 Level: $25 Million Total.--
The AAP is tremendously appreciative of and applauds Congress for
continuing to provide $25 million total, split evenly between CDC and
NIH, for firearm injury and mortality prevention research in FY 21. In
the midst of the COVID-19 pandemic, communities across the U.S.
continue to suffer from the public health crisis of firearm-related
injuries and deaths with early data showing 2020 being a record-
breaking year for gun violence, injuries, and deaths. A public health
approach to firearm violence prevention is urgently needed to promote
health equity and address the disproportionate burden of this epidemic
on communities of color. The foundation of this approach is rigorous
research that can accurately quantify and describe the facets of an
issue and identify opportunities for reducing its related morbidity and
mortality. The initial investments in FY20 and FY21 are important, but
increased funding is still needed to overcome the decades-long lack of
federal funding that set back our nation's response to the public
health issue of firearm-related morbidity and mortality. Over time,
additional funding can generate research into important issues such as
the best ways to prevent unintended firearm injuries and fatalities
among women and children; the most effective methods to prevent
firearm-related suicides; the measures that can best prevent the next
shooting at a school or public place; and numerous other vital public
health questions. Continued and expanded investments are essential to
the success of this important work.
Pediatric Mental Health Care Access Grants (HRSA):
FY 22 Request: $10 Million; FY 21 Level: $10 Million.--The AAP
appreciates the additional funds included in the American Rescue Plan
for the Pediatric Mental Health Care Access Grants, in recognition of
the impact of COVID-19 on child and adolescent mental health, and urges
Congress to continue providing $10 million for FY 22 appropriations.
This program supports the development of new statewide or regional
pediatric mental health care telehealth access programs, as well as the
improvement of already existing programs. Research shows pervasive
shortages of child and adolescent mental/behavioral health specialists
throughout the U.S. Integrating mental health and primary care has been
shown to substantially expand access to mental health care, improve
health and functional outcomes, increase satisfaction with care, and
achieve costs savings.
Activities Authorized under Scarlett's Sunshine Act (CDC/HRSA):
FY 22 Request: $12 Million; FY 21: Level: N/A.--The AAP urges
Congress to provide first-time appropriations of $12 million to
implement the Scarlett's Sunshine Act. Little is known about the
tragic, sudden and unexpected deaths of young children because of
variations in investigations and death certifications. Enacted in
December 2020, this law will help states better understand sudden
unexpected infant death and sudden unexpected death in childhood,
facilitate data collection and analysis to improve prevention, and
support grieving families. Funds should support work at both CDC and
HRSA's Maternal Child Health Bureau given their complementary efforts
on this issue.
Emergency Medical Services for Children (HRSA):
FY 2022 Request: $22.334 Million; FY 21 Level: $22.334 Million.--
The AAP urges the committee to maintain $22.334 million in funding for
the Emergency Medical Services for Children (EMSC) Program in FY 22.
EMSC is the only federal program that focuses specifically on improving
the pediatric components of the emergency medical services (EMS)
system. EMSC aims to ensure state of the art emergency medical care is
available for the ill and injured child or adolescent, pediatric
services are well integrated into an EMS system backed by optimal
resources, and that the entire spectrum of emergency services is
provided to all children and adolescents no matter where they live.
National Center for Birth Defects and Developmental Disabilities (CDC):
FY 22 Request: $280 Million; FY 21 Level: $167.8 Million.--The AAP
requests $280 million for FY 22 for the National Center for Birth
Defects and Developmental Disabilities (NCBDDD), including $100 million
for Surveillance for Emerging Threats to Mothers and Babies (SET-NET).
This would allow the program to scale nationally and serve as the
nationwide preparedness and response network the United States needs to
protect pregnant individuals and infants from emerging public health
threats. According to the CDC, birth defects affect 1 in 33 babies and
are a leading cause of infant death in the United States. NCBDDD
conducts important research on fetal alcohol syndrome, infant health,
autism, attention deficit and hyperactivity disorders, congenital heart
defects, and other conditions like Tourette Syndrome, Fragile X, Spina
Bifida and Hemophilia. NCBDDD supports extramural research in every
State and has played a crucial role in the country's response to the
Zika virus, as well as COVID-19.
Global Immunization--Polio and Measles/Other (CDC):
FY 22 Request: $271.2 Million ($176 Million for Polio and $50
Million for Measles/Other); FY 21 Level: $226 Million ($176 Million for
Polio and $50 million for Measles/Other).--Vaccines are one of the most
cost-effective and successful public health solutions available. The
CDC provides countries with technical assistance and disease
surveillance support, with a focus on eradicating polio, reducing
measles deaths, and strengthening routine vaccine delivery. Global
mortality attributed to measles declined by 79% between 2000 and 2015
thanks to expanded immunization, saving an estimated 20.3 million
lives. Unfortunately, the gains from global immunization are in
jeopardy. During the COVID-19 pandemic, many countries diverted
resources set aside for polio and routine immunizations to fight the
pandemic. To finance immunization gaps in countries and recover from
pandemic-related disruptions requires an additional $255 million over
the next three years. Failing to close these gaps will leave millions
of children at risk and will compromise U.S. global health security due
to increased possibility of importing highly infectious diseases like
measles into the U.S.
Activities Authorized under the VACCINES Act (CDC):
FY 22 Request: $15 Million; FY 21 Level: N/A.--The AAP is very
appreciative that Congress specifically included the Vaccine Awareness
Campaign to Champion Immunization Nationally and Enhance Safety
(VACCINES) Act as part of Section 2302 of the American Rescue Plan that
provided $1 billion to improve vaccine confidence for both COVID-19 and
routine immunizations. We urge Congress to include $15 million
authorized by the VACCINES Act for CDC to research vaccine hesitancy
and establish an evidence-based public awareness campaign to help
improve vaccination rates across the lifespan. We also urge Congress to
request a report on the progress of these activities at the CDC.
There are many ways Congress can help meet children's needs and
protect their health and well-being. Adequate funding for children's
health programs is one of them. The American Academy of Pediatrics
looks forward to working with Members of Congress to prioritize the
health of our nation's children in FY 2022 and beyond. If we may be of
further assistance, please contact the AAP Department of Federal
Affairs at [email protected]. Thank you for your consideration.
[This statement was submitted by Lee Savio Beers, MD, FAAP,
President,
American Academy of Pediatrics.]
______
Prepared Statement of the American Alliance of Museums
Chairwoman Murray, Ranking Member Blunt, and members of the
subcommittee, thank you for the opportunity to submit this testimony.
My name is Laura Lott, and I am President and CEO of the American
Alliance of Museums (AAM). I urge you to provide the Office of Museum
Services (OMS) within the Institute of Museum and Library Services
(IMLS) with $80 million for fiscal year (FY) 2022, an increase of $39.5
million. We request that $2.5 million of this increase be directed to
explore establishing, and to fund projects related to, a roadmap to
strengthen the structural support for a museum Grants to States program
administered by OMS, as authorized by the Museum and Library Services
Act, in addition to the agency's current critical direct grants to
museums.
AAM--representing more than 35,000 individual museum professionals
and volunteers, museums of all types, and corporate partners serving
the museum field--stands for the broad scope of the museum community.
I want to express the museum field's gratitude for the $40.5
million in funding for OMS in FY 2021, and we applaud the bipartisan
group of 41 Senators who recently wrote to you in support of FY 2022
OMS funding. We also applaud the President's budget proposal for
additional funding for OMS for the grants program authorized by the
African American History and Culture Act and the grants program
authorized by the National Museum of the American Latino Act as steps
in the right direction. OMS is a vital investment in protecting our
nation's cultural treasures, educating students and lifelong learners
alike, and bolstering local economies. During the COVID-19 pandemic,
OMS has provided critical leadership to the museum community through
its CARES Act grants. For example, the agency has been providing
science-based information and recommended practices to reduce the risk
of transmission of COVID-19 to staff and visitors engaging in the
delivery of museum services.
Through the IMLS CARES Act Grants to Museums and Libraries, IMLS
awarded $13.8 million to 68 museums and libraries to support their
response to the coronavirus pandemic. IMLS received 1088 applications
from museums but was only able to fund 39 awards, fewer than 4 percent
of the applications, for a total of $8.28 million--far below the $261.5
million requested. Unfortunately, none or very little of the $200
million allocated to IMLS in the American Rescue Plan is expected to be
awarded to museums.
Museums are a robust and diverse business sector, including African
American museums, aquariums, arboreta, art museums, botanic gardens,
children's museums, culturally-specific museums, historic sites,
historical societies, history museums, maritime museums, military
museums, natural history museums, planetariums, presidential libraries,
public gardens, railway museums, science and technology centers, and
zoos.
Museums are economic engines and job creators: According to Museums
as Economic Engines: A National Report, pre-pandemic U.S. museums
supported more than 726,000 jobs and contributed $50 billion to the
U.S. economy per year, including significant impact on individual
states. For example, the total financial impact that museums have on
the economy in the state of Washington is $1.01 billion, supporting
14,145 jobs. For Missouri it is a $852 million impact, including 13,653
jobs. Nationally, museums spend more than $2 billion yearly on
education activities and the typical museum devotes 75% of its
education budget to K-12 students.
IMLS is the primary federal agency responsible for helping museums
connect people to information and ideas. OMS supports all types of
museums--from art museums to zoos--by awarding grants that help them
better serve their communities. OMS awards grants in every state to
help museums digitize, enhance, and preserve collections; provide
teacher professional development; and create innovative, cross-
cultural, and multi-disciplinary programs and exhibits for schools and
the public. Congress reauthorized IMLS at the end of 2018, with wide
bipartisan support. OMS grants to museums are highly competitive and
decided through a rigorous peer-review process. In addition to the
dollar-for-dollar match generally required of museums, grants often
spur more giving by private foundations and individual donors.
There is high demand for funding from OMS. In FY 2020 OMS received
784 applications requesting nearly $146 million, but current funding
has allowed the agency to fund only a small fraction of the highly
rated grant applications it receives. $80 million would allow OMS to
double its grant capacity for museums, funds that museums will need to
help recover from the pandemic and continue to serve their communities.
This substantial funding increase would still be greatly shy of the
high demand of $146 million in highly rated grant applications. A
Grants to States program administered by OMS, in addition to the
agency's current direct grants to museums, would merge federal
priorities with state-defined needs, expand the reach of museums, and
increase their ability to serve their communities, address underserved
populations, and meet the needs of the current and future museum
workforce.
Museums are vital to our nation's recovery from this pandemic, and
after sudden and long-term closures, they will require financial
assistance to reopen, maintain their staffs, provide educational
programs to communities, and assist in rebuilding local tourism
economies. PPP 1 and PPP 2, and Shuttered Venue Operators Grants
(limited to museums with theatres with fixed seating) have and will
provide a critical lifeline for many museums. But the museum field will
need robust ongoing support from IMLS, especially as not all museums
were eligible for pandemic relief funds. According to a report by
McKinsey and Company, the arts, entertainment, and recreation sectors
will not fully recover from this public health crisis and muted economy
until 2025.
Recent survey data confirmed that the dire economic harm to museums
caused by the COVID-19 pandemic will result in a long road to recovery
for the field. Three-quarters of museums (76 percent) report that their
operating income fell an average of 40 percent in 2020 while their
doors were closed to the public for an average of 28 weeks due to the
pandemic. Museums have largely been unable to offset losses by cutting
expenditures. Fifteen percent (the equivalent of more than 5,000 US
museums) confirmed there was a ``significant risk of permanent
closure'' or they ``didn't know'' if they would survive the next six
months absent additional financial relief. Nearly half (46 percent) of
museums surveyed report that their total staff size has decreased by an
average of 29 percent compared with pre-pandemic levels. Only 44
percent of all respondents plan to rehire or increase their staff size
in the coming year. Pre-pandemic museums supported 726,000 jobs. Fifty-
nine percent of responding museums were forced to cut back on
education, programming, and other public services due to budget
shortfalls and/or staff reductions during the pandemic. Thirty-nine
percent of responding museums require investments in their building,
HVAC equipment, and other infrastructure to improve energy efficiency
and reduce the environmental impact of their operations. The average
anticipated cost of these improvements is $668,000 per museum.
Despite economic distress, museums have been filling critical gaps
in our communities. During the pandemic, museum professionals--severely
impacted by the pandemic themselves-stepped up by serving the needs of
their communities. They are addressing education gaps and contributing
to the ongoing education of our country's children by providing free
lesson plans, online learning opportunities, and drop-off learning kits
to teachers and families. Museums are using their outdoor spaces to
grow and donate produce to area food banks and are maintaining these
spaces for individuals to safely relax, enjoy nature, and recover from
the mental health impacts of social isolation. They have donated their
PPE and scientific equipment to fight COVID-19, and provided access to
child care and meals to families of health care workers and first
responders. In the midst of financial distress, they are even raising
funds for community relief and providing reliable information on COVID-
19 and vaccinations, some even serving as vaccination sites themselves.
Museums are pivotal to our nation's ability to manage through the
pandemic and recover from it as our nation opens back up.
Here are just a few examples of how OMS helps museums better serve
their communities:
In 2021, the Suquamish Indian Tribe of the Port Madison Reservation
in Washington was awarded a $85,400 Native American/Native Hawaiian
Museum Services grant to update an oral history project conducted from
1981-83 that has guided the development of the Suquamish Museum for
over 30 years. The project will engage the 78 Suquamish elders who are
70 years of age and older to document their biographical, cultural, and
personal knowledge for use in more contemporary programming and museum
exhibits. Although the tribe recognized the need to gather oral
histories during a retreat in 2018, the COVID-19 pandemic not only
increased the sense of urgency but provided time to consider a plan for
the project. Collecting oral histories of experiences in the more
recent past will guide long range planning and help the museum focus
its collections acquisitions for the next foreseeable decades.
In 2020, the Seattle Art Museum in Washington was awarded a
$216,970 Museums for America grant to expand its early learner
initiative known as Artful Beginnings to create increased opportunities
for hands-on arts learning and engagement for children ages 2 through
6, their caregivers, and educators. The focus is on three core Artful
Beginnings programs: Tiny Tots Workshops and Family Fun Storytime, Art
Adventures, and an art-based outdoor preschool curriculum with Tiny
Trees. The museum's three locations--as well as community partner
facilities in South Seattle and South King County--will host the
programs. Programming will focus on engaging traditionally underserved
and lower-income audiences. The project underscores the museum's
commitment to equity and inclusion and will work to engage all
audiences more deeply.
In 2020, Port Townsend Marine Science Society in Washington was
awarded a $49,613 Program Inspire! Grants for Small Museums grant to
complete an exhibition master plan as part of a larger facility
improvement project. The expanded and renovated facility will create an
accessible, unified, cohesive exhibition experience with strong content
linkages and seamless indoor-outdoor integration that gives the feeling
of a journey into the Salish Sea. The process of developing the
exhibition master plan will involve formative evaluation, including
site visits, surveys, focus groups, and consultations with
professionals. Representatives of key stakeholder groups, including
educators and students, volunteers, marine conservation professionals,
and other Salish Sea environmental organizations will provide input on
the plan concept and exhibition content. The center intends to inspire
responsible stewardship of global oceans through the development of
immersive, informative content.
In 2020, the Walt Disney Hometown Museum in Marceline, Missouri,
was awarded a $38,240 Program Inspire! Grants for Small Museums grant
to expand its education and professional development programs for rural
educators. The initiative is the result of a collaborative partnership
that includes museum staff, K-16 educators, and others from the local
community. Educators will have the opportunity to participate in an
immersive learning workshop program where they will experience and
explore place-based learning opportunities alongside guided
instructional planning. The initiative will solidify bonds between the
museum and the community, as educators and museum personnel collaborate
to strengthen their understanding of how local culture connects to
learning.
In 2020, the Missouri Botanical Garden in Saint Louis, Missouri,
was awarded a $202,220 Museums for America grant to create a Butterfly
House Entomology Lab to serve as a functional space for staff and
volunteers to properly care for their invertebrate animal collection
while providing guests an interactive experience. This exhibition will
promote learning experiences focused on the butterfly life cycle,
invertebrate animal conservation, and the field of entomology. The
project also will include the addition of digital components such as
monitors that highlight the characteristics of each display species and
their region of origin. The addition of technology also will allow
virtual field trips to the Butterfly House Entomology Lab.
In closing, I highlight recent national public opinion polling that
shows that 95% of voters would approve of lawmakers who acted to
support museums and 96% want federal funding for museums to be
maintained or increased. Museums have a profound positive impact on
society.
If I can provide any additional information, I would be delighted
to do so. Thank you again for the opportunity to submit this testimony.
[This statement was submitted by Laura L. Lott, President/CEO,
American
Alliance of Museums.]
______
Prepared Statement of the American Association for Cancer Research
Chair Murray, Ranking Member Blunt, and members of the subcommittee
and staff, thank you for the opportunity to submit testimony. I am Dr.
David Tuveson, Director of the Cold Spring Harbor Laboratory Cancer
Center and Chief Scientist for the Lustgarten Foundation, the largest
pancreatic cancer research philanthropic organization. I am submitting
testimony as President of the American Association for Cancer Research
(AACR). On behalf of the AACR's 48,000 members, I ask for your support
for at least $46.1 billion in FY 2022 funding for the National
Institutes of Health (NIH), and $7.6 billion for the National Cancer
Institute (NCI).
We are in an era of unprecedented progress against cancer,
including advances in immunotherapies and targeted anti-cancer
therapies that led to spectacular decreases in cancer mortality. Thanks
to investments at the NCI, we have new tools at our disposal that could
only be dreamed of decades ago to maximize advances in early diagnosis
of many types of cancer and offer highly effective treatments that
improve health outcomes and reduce health disparities. Additionally,
the funding that NCI provides to the NCI-designated cancer centers that
are located all throughout the country is supporting pioneering new
research, serving patients in their communities, and training the next
generation of cancer scientists.
There are so many breakthroughs within our grasp, but to achieve
them, we need federal investments to keep up with demand on basic
research for cancer.
Since FY 2015, thanks to your leadership, NIH funding has increased
by nearly 42%. But due to other funding needs at NIH, including worthy
initiatives that take away from the top line, and a nearly 50% increase
in applications at NCI since 2013, the funding increases have not kept
up with demand.
Even with the significant funding you have provided, the percent of
NCI grant applications that are funded, referred to as the success
rate, is among the lowest of all institutes at NIH. In FY 2020, the
NIH-wide success rate for competing research project grants, or RPGs,
was nearly 21%. For NCI, it was only 12.8%, and that's the highest
NCI's success rate has been in six years.
NCI has been stretching dollars to fund more grants. NCI Director,
Dr. Sharpless, released his 15-by-25 milestone, an effort to increase
the number of R01 grants funded until it reaches the 15th percentile in
2025. The AACR strongly supports this important mission, but to achieve
the goal of funding more meritorious research, more funding will be
needed.
While the success rate of an RPG at NHLBI is 22.2%, and NIDDK is
23%, NIAID is 23.9%, and the National Institute on Aging is 25.8%,
NCI's rate of 12.8% is not sustainable to meet our pledge to apply new
cancer science and medicine towards improving patient outcomes. With
the low success rate, I worry the best and the brightest, in particular
early-stage researchers, will choose other career paths. The United
States cannot lead the world in cancer discoveries if the NCI success
rate is so low that researchers choose another field.
Thanks to your leadership, language was included in the last two
explanatory statements to prioritize competing grants and sustain
commitments to continuing grants. I humbly ask you to continue these
efforts in FY 2022 and provide funding to meet Dr. Sharpless' goal so
the cancer research community can accelerate the path to discoveries
and save lives.
I know cancer is personal for you, as it is for me. Thank you for
this opportunity and for your commitment to bringing us closer to our
mutual goal of conquering cancer.
[This statement was submitted by David A. Tuveson, MD, PhD, FAACR,
President, American Association for Cancer Research.]
______
Prepared Statement of the American Association for Clinical Chemistry
The American Association for Clinical Chemistry (AACC) welcomes the
opportunity to provide testimony to the Senate Appropriations
Subcommittee on Labor, Health & Human Services, and Education regarding
our nation's fiscal year (FY) 2022 budget priorities. AACC and its
partners are urging the subcommittee to support two initiatives vital
to improving the quality and efficacy of healthcare in the United
States:
--Improving Pediatric Reference Intervals--$10 million for the
Centers for Disease Control and Prevention, Division of
Laboratory Services, Environmental Health Laboratory to improve
the quality of pediatric reference intervals used by health
practitioners to diagnose, monitor, and treat children.
--Harmonizing Clinical Laboratory Test Results--an additional $7.2
million ($9.2 million in total) for the Centers for Disease
Control and Prevention, Division of Laboratory Services,
Environmental Health Laboratory to continue its ongoing efforts
to harmonize the reporting of clinical laboratory test results,
which is the vital to providing better, more consistent
healthcare in the United States.
improving pediatric reference intervals
AACC, the American Academy of Pediatrics, the Children's Hospitals
Association, and 30 other organizations have written to the
subcommittee urging additional funding for the Centers for Disease
Control and Prevention (CDC) to improve the quality of pediatric
reference intervals (PRIs)--the range of numeric values expected in a
healthy child--available to health practitioners to care for their
young patients.
When making a diagnosis, the healthcare professional considers a
laboratory test value within the context of a reference interval. If
the test result falls outside of the defined reference interval for a
healthy child--either higher or lower--the practitioner may order a
medical intervention to address a health condition or change an ongoing
treatment protocol. If the diagnosis or treatment change is incorrect
for any reason, including an inaccurate reference interval, it could
result in patient harm. Therefore, it is critical that the range of
values used by practitioners to interpret test results are accurate.
Whereas the reference intervals for adults are generally reliable,
there is considerable inconsistency and large gaps in the ranges
available for children. Healthcare practitioners need reference
intervals reflective of healthy children at each unique stage of
physical development from birth through adolescence to adulthood. In
addition, the intervals must also take into consideration any
variations due to biological factors, such as ethnicity and gender.
Accurate and actionable PRIs are particularly important for our
youngest patients, who are often unable to verbally communicate their
symptoms. Unfortunately, most laboratories are unable to obtain enough
samples from a diverse, healthy population of children to develop their
own reference intervals.
Congress recognized the importance of this issue when in the
accompanying report language to the Further Consolidated Appropriations
Act of 2020 it requested CDC to develop and submit a plan for improving
PRIs. The agency outlined its plan in the Department of Health and
Human Services fiscal year 2021 congressional justification to
Congress. The plan calls for the CDC to employ its existing
infrastructure to initiate and advance this vital work. According to
CDC, it can:
--collect clinical samples through its National Health and Nutrition
Examination Survey (NHANES), which has the organization and
expertise to collect specimens from healthy children; and
--utilize its Environmental Health Laboratory (EHL) to generate the
reference intervals for children and disseminate the
information to clinical laboratories. EHL has developed
reference intervals in the past.
AACC and its partners support providing CDC with an additional $10
million to improve the quality of PRIs critical to caring for our
nation's children.
harmonizing clinical laboratory test results
Another issue that AACC and its allies request your assistance with
is the harmonization of clinical laboratory test results. Laboratory
test methods provide accurate test results, but different methods
generate different numeric values. With different methods in use across
the healthcare system, lack of harmonization makes it difficult to
develop widely applicable clinical guidelines or performance measures.
It also complicates data aggregation, which limits the development of
tools to better inform health decision-making.
Tests that are harmonized (or standardized) provide the same
numeric value for a condition regardless of the method or instrument
used or the setting where the tests are performed. An early example of
harmonization is cholesterol, which is widely utilized by the medical
community to diagnose heart disease. A 2011 study published in
Preventing Chronic Disease reports that early drug intervention based
on cholesterol levels saved the health system $338 million to $7.6
billion annually between 1980--2000.\1\ Harmonization can improve
patient care while also saving money.
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\1\ Hoerger TJ, Wittenborn JS, Young W. A cost-benefit analysis of
lipid standardization in the United States. Preventing Chronic Disease
2011; 8: A136.
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In recent years, Congress has supported the expansion of CDC's
harmonization efforts, resulting in new activities to improve the
detection and management of hormone disorders, kidney disease, cancer,
and heart disease. With additional funding, the agency will be able to
expand its harmonization activities to develop materials for non-
traditional biomarkers, such as apolipoproteins, and the assessment of
point of care testing devices that are increasingly being used by
healthcare providers and patients.
AACC and its partners respectfully request that the subcommittee
provide an additional $7.2 million ($9.2 million in total) for the CDC
to continue and advance its harmonization activities. Congress has
provided $2 million annually for this program since FY18.
AACC is a global scientific and medical professional organization
dedicated to clinical laboratory science and its application to
healthcare. We look forward to working with the subcommittee on these
most important issues as it goes through the FY22 budget process. If
you have any questions, please email Vince Stine, PhD, AACC's Senior
Director of Government and Global Affairs, at [email protected].
[This statement was submitted by David Grenache, PhD, D(ABCC),
President, American Association for Clinical Chemistry.]
______
Prepared Statement of the American Association for Dental Research
On behalf of the American Association for Dental Research (AADR), I
am pleased to submit testimony describing AADR's funding requests for
fiscal year (FY) 2022. I currently serve as the chair of the Board of
Directors and president of the Association. I am a professor in the
Department of Diagnostic and Biological Sciences at the University of
Minnesota School of Dentistry, where I also serve as the director
emeritus of the Minnesota Craniofacial Research Training Program
(MinnCResT).
For FY 2022, the American Association for Dental Research--along
with our colleagues in the oral health community--is seeking at least
$520 million for the National Institute of Dental and Craniofacial
Research (NIDCR) and at least $46.111 billion for all of the Institutes
and Centers at the National Institutes of Health (NIH). Funding at
these recommended levels will allow for the entities' base budgets to
keep pace with the biomedical research and development price index
(BRDPI) and provide meaningful growth of 5%.
As our nation continues to respond to the global COVID-19 pandemic,
we are reminded of the importance of the federal investment in science,
and in particular, biomedical research. AADR is grateful to Congress
for consistently prioritizing this research at NIH by providing steady
and meaningful funding increases, which will be more important than
ever to carry forward in the wake of the pandemic. While we recognize
there will be funding challenges in FY 2022 given the tremendous
resources allocated to COVID-19 relief, we cannot afford to underfund
our nation's research agencies now. Underfunding will leave us ill-
equipped to complete our exit from the current pandemic, deal with
future pandemics, and risk losing the progress that has been made by
congressional investment in biomedical research.
The requested 5% growth above BRDPI would provide critical support
for these research agencies, which have been among the many enterprises
negatively impacted by this public health crisis. The ongoing pandemic
caused closures of university campuses and forced laboratories to scale
back or halt research projects. It also required research agencies to
shift existing resources and funding to coronavirus-related research at
the expense of other important scientific inquiries about health and
disease.
NIDCR--the largest institution dedicated exclusively to research to
improve dental, oral and craniofacial (skull and face) health--is one
the NIH Institutes and Centers that has prioritized COVID-19 research.
To date, NIDCR has funded approximately $3.9 million of immediate and
high impact research to protect and ensure the safety of personnel and
patients in dental practices during the COVID-19 pandemic. The
Institute will soon release a second round of funding related to COVID-
19.\1\ Funding for NIDCR COVID-19 research is critical to the nation's
public health, supporting work that includes the use of personal
protective equipment (PPE) in dental settings, aerosol and droplet
transmission in dental settings, the infection of salivary glands and
oral tissues by SARS-CoV-,\2\ and the use of biosensors to detect SARS-
CoV-2 in saliva.
This important research agenda with broad public health impact
notwithstanding, NIDCR was not included among the NIH Institutes and
Centers to receive targeted supplemental funding in COVID-19 relief
legislation--nor has the annual investment in NIDCR kept pace with the
overall funding increases provided to NIH over the past several years.
Funding of at least $520 million in FY 2022 would help bring NIDCR
funding into alignment with the overall NIH request and allow NIDCR to
build on its myriad successes in its mission to improve dental, oral
and craniofacial health.
Oral health--too often considered in isolation--is integral to
overall health. The research being conducted at, and supported by,
NIDCR impacts the lives of millions of Americans. Oral health can
affect activities that may be taken for granted: the ability to eat,
drink, swallow, smile, speak, and maintain proper nutrition. The oral
cavity also serves as a window into potential health issues, including
but not limited to systemic diseases, such as diabetes, HIV/AIDS and
Sjogren's, an autoimmune disease that causes one's immune system to
attack parts of its own body.
Coronavirus research shows that the virus can infect more than the
upper airways and lungs, but also cells in other parts of the body. In
fact, recent NIDCR-supported research has also shown that the novel
coronavirus can infect cells in the mouth. As the study's authors
explain.\2\ :
``The potential of the virus to infect multiple areas of the body
might help explain the wide-ranging symptoms experienced by COVID-19
patients, including oral symptoms such as taste loss, dry mouth and
blistering. Moreover, the findings point to the possibility that the
mouth plays a role in transmitting SARS-CoV-2 to the lungs or digestive
system via saliva laden with virus from infected oral cells.''
According to NIDCR's press release on the study, this research is
contributing to our understanding of COVID-19, including oral
transmission, and could inform interventions to help combat the virus
and alleviate the associated oral symptoms. Indeed, this seminal
research may have important implications to explain why super-spreader
events occur in places where people sing, speak loudly, or party.
Dental, oral and craniofacial research presents vast research
opportunities, and we know NIDCR will continue to be the key player in
advancing our understanding of the role of the mouth and oral tissues
in many scientific frontiers going forward. One path to highlighting
the Institute's work and the future of this research in the United
States is through the U.S. Surgeon General's Report on Oral Health, a
critical update to the seminal ``Oral Health in America'' report from
July 2000. The report--originally set to be released in the fall of
2020--will document the progress in the improvement of oral health
since 2000, provide insight into issues currently affecting oral
health, and identify opportunities and challenges that have emerged
over the past 20 years. The 2000 report shifted perspectives among the
public and policymakers by showing that oral health goes beyond healthy
teeth and gums and that it is essential to our general health and well-
being. We believe the 2020 report will also have a significant impact,
and we have encouraged the administration to swiftly review and release
the report. The long-awaited report is a critical public health
document and is essential to moving our nation's health forward.
In addition to the important work of NIDCR, AADR recognizes that
federal research and public health efforts work in concert and that
success in one area can benefit another. Therefore, we encourage
Congress--in addition to supporting NIH and NIDCR in FY 2022, to
support the full breadth of federal agencies supporting oral health.
Complementing our NIDCR and NIH requests, we urge you to provide $30
million for the CDC's Division of Oral Health, $46 million for the
Title VII Health Resources and Services Administration (HRSA) programs
that train the dental health workforce, at least $500 million for the
Agency for Healthcare Research and Quality (AHRQ), and at least $200
million for the National Center for Health Statistics (NCHS).
The COVID-19 crisis shook our nation and reminded us of the
critical role biomedical and public health research play in our
society. Over the course of 2020 and 2021, we saw how the research
enterprise can safeguard public health, national security and economic
growth. We urge Congress to continue to prioritize biomedical research,
including dental, oral and craniofacial research in FY 2022 so our
nation's citizens can continue to enjoy the benefits of state-of-the-
art, world-leading health care.
We appreciate the opportunity to submit this testimony and thank
the Subcommittee for considering our request of at least $520 million
in funding for NICDR and at least $46.111 billion for the Institutes
and Centers at NIH. AADR stands ready to assist the Congress in any way
we can and to answer any questions you may have.
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\1\ National Advisory Dental and Craniofacial Research Council--
January 2021. National Institutes of Health, 2021. https://
videocast.nih.gov/watch=38984.
\2\ Scientists Find Evidence that Novel Coronavirus Infects the
Mouth's Cells. Press Release, NIDCR. https://www.nidcr.nih.gov/news-
events/nidcr-news/2021/scientists-find-evidence-novel-coronavirus-
infects-mouths-cells; Huang, N., Perez, P., Kato, T. et al. SARS-CoV-2
infection of the oral cavity and saliva. Nat Med 27, 892-903 (2021).
https://doi.org/10.1038/s41591-021-01296-8.
[This statement was submitted by Mark C. Herzberg, D.D.S., Ph.D.,
President, American Association for Dental Research.]
______
Prepared Statement of the American Association of Colleges of Nursing
strengthening the current and future nursing workforce
On behalf of the American Association of Colleges of Nursing
(AACN), we want to thank the Subcommittee for its leadership and
continued support of nursing education, the nursing profession, and
nursing research, especially during this unprecedented time. As the
national voice for academic nursing, AACN represents nearly 840 schools
of nursing at private and public universities, who educate more than
580,000 students and employ more than 52,000 faculty.\1\ Collectively,
these institutions play a critical role in protecting the health of our
nation by graduating registered nurses (RN), advanced practice
registered nurses (APRN), educators, researchers, and other frontline
providers. As we work to combat current public health challenges, such
as COVID-19, and prepare for the future, ensuring a robust supply of
nursing professionals requires a strong and sustained federal
investment. For Fiscal Year (FY) 2022, AACN respectfully requests that
you provide bold support of at least $530 million for the Nursing
Workforce Development Programs (Title VIII of the Public Health Service
Act [42 U.S.C. 296 et seq.] administered by HRSA and at least $199.755
million for the National Institute of Nursing Research (NINR), which
was included in the President's FY 2022 Budget.
---------------------------------------------------------------------------
\1\ American Association of Colleges of Nursing. (2021) Who We Are.
Retrieved from: https://www.aacnnursing.org/About-AACN/Who-We-Are.
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the growing nursing workforce demand
Nurses comprise the largest sector of the healthcare workforce with
more than four million RNs and APRNs, which include Nurse Practitioners
(NPs), Certified Registered Nurse Anesthetists (CRNAs), Certified
Nurse-Midwives (CNMs), and Clinical Nurse Specialists (CNSs).\2\ Nurse
educators, students, and practitioners are leaders within their
institutions and communities; many of whom are also serving on the
frontlines of the COVID-19 public health emergency. Even prior to
COVID-19, our nation was in need of additional nurses. This demand is
only expected to grow as we continue to combat the pandemic and address
the healthcare needs of all patients, including those in rural and
underserved areas. In fact, the Bureau of Labor Statistics' outlook for
RN workforce demand projected an increase of 7% by 2029, representing
the need for an additional 221,900 jobs.\3\ Additionally, the need for
most APRNs is expected to grow by 45%.\4\ This increasing demand in the
nursing workforce can be attributed to several factors such as an aging
population, nursing retirements, and an increase in workplace
stress.\5\ Bold investments in Title VIII Nursing Workforce Development
Programs and NINR would help prepare a highly educated nursing
workforce and strengthen the foundation of nursing science, not only as
we confront existing health challenges, but as we provide tomorrow's
equitable and innovative healthcare solutions.
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\2\ National Council of State Boards of Nursing. (2021). Active RN
Licenses: A profile of nursing licensure in the U.S. as of April 23,
2021. Retrieved from: https://www.ncsbn.org/6161.htm.
\3\ U.S. Bureau of Labor Statistics. (2021). Occupational Outlook
Handbook-Registered Nurses. Retrieved from: https://www.bls.gov/ooh/
healthcare/registered-nurses.htm.
\4\ U.S. Bureau of Labor Statistics. (2021). Occupational Outlook
Handbook-Nurse Anesthetists, Nurse Midwives, and Nurse Practitioners.
Retrieved from: https://www.bls.gov/ooh/healthcare/nurse-anesthetists-
nurse-midwives-and-nurse-practitioners.htm.
\5\ American Association of Colleges of Nursing. (2020) Fact Sheet:
Nursing Shortage. Retrieved from: https://www.aacnnursing.org/Portals/
42/News/Factsheets/Nursing-Shortage-Factsheet.pdf.
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nursing workforce investments: sustaining education to secure a strong
nursing workforce
Our ongoing efforts to combat COVID-19 have made it abundantly
clear that a well-educated nursing workforce is essential. For over
fifty years, Title VIII Nursing Workforce Development Programs have
been a catalyst for strengthening nursing education at all levels, from
entry-level preparation through graduate study. Through grants,
scholarships, and loan repayment programs, Title VIII federal
investments positively impact the profession's ability to serve
America's patients in all areas, bolster diversity within the
workforce, and increase the number of nurses, including those at the
forefront of public health emergencies and caring for our aging
population.
Each Title VIII Nursing Workforce Development Program provides a
unique and crucial mission to support nursing education and the
profession. For example, the Advanced Nursing Education (ANE) programs
help increase the number of APRNs in the primary care workforce and
supported more than 8,200 students in Academic Year 2019-2020 alone.\6\
In addition, the Nurse Faculty Loan Program (NFLP) awarded 45 grants to
schools that supported 2,270 graduate nursing students in Academic Year
2019-2020.\7\ According to AACN's Annual Survey, student enrollment in
entry-level baccalaureate nursing programs increased by 5.6% in
2020.\8\ While this heightened interest in nursing education is
promising news, we need to ensure these students have ample nursing
faculty to guide them through their clinical and didactic education and
prepare them to respond to our nation's ever-changing healthcare
environment.
---------------------------------------------------------------------------
\6\ Department of Health and Human Services Fiscal Year 2022 Health
Resources and Services Administration Justification of Estimates for
Appropriations Committees. Pages 153-155. Retrieved from: https://
www.hrsa.gov/sites/default/files/hrsa/about/budget/budget-
justification-fy2022.pdf.
\7\ Department of Health and Human Services Fiscal Year 2022 Health
Resources and Services Administration Justification of Estimates for
Appropriations Committees. Page 167. Retrieved from: https://
www.hrsa.gov/sites/default/files/hrsa/about/budget/budget-
justification-fy2022.pdf.
\8\ American Association of Colleges of Nursing. (2021). Student
Enrollment Surged in U.S. Schools of Nursing in 2020 Despite Challenges
Presented by the Pandemic. Retrieved from https://www.aacnnursing.org/
News-Information/Press-Releases/View/ArticleId/24802/2020-survey-data-
student-enrollment%20%20%20%20%20.
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As we address social determinants of health and work to build an
equitable healthcare system for all patients, it is imperative that we
recruit individuals from diverse backgrounds to the nursing profession.
Increasing diversity in the profession will not only create lifelong
career pathways, but will also improve care quality and access to
population-centered care. The Nursing Workforce Diversity (NWD) program
serves as a glowing example of a successful Title VIII initiative that
accomplishes this goal. In fact, in Academic Year 2019-2020, the NWD
program awarded grants supporting 11,620 nursing students from
disadvantaged backgrounds.\9\ The recruitment of underrepresented
racial and ethnic individuals and those from economically diverse
backgrounds to nursing positively impacts the classroom, professional
practice environments, and ultimately patients.
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\9\ Department of Health and Human Services Fiscal Year 2022 Health
Resources and Services Administration Justification of Estimates for
Appropriations Committees. Page 159. Retrieved from: https://
www.hrsa.gov/sites/default/files/hrsa/about/budget/budget-
justification-fy2022.pdf.
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As such, to ensure the stability of our nursing workforce now and
in the future, we request at least $530 million for Title VIII Nursing
Workforce Programs.
from research to reality: nursing science protects americans' health
AACN recognizes how scientific research and discovery is the
foundation on which nursing practice is built and is essential to
advancing evidence-based interventions, informing policy, and
sustaining the health of the nation. As one of the 27 Institutes and
Centers at NIH, NINR plays a fundamental role in improving care and is
on the cutting edge of new innovations impacting how nurses are
educated and how they practice. In fact, 80% of research-focused
educational training grants at nursing schools are funded by NINR.\10\
Through these grants and others, nurse scientists, often working
collaboratively with other health professionals, are generating and
translating impactful new research in areas such as big data and data
science, precision health, and genomics.\11\ Despite the critical
research these grants support, NINR was only able to fund 8.9% of grant
applications in 2017, due to insufficient funding.\12\ This is the
lowest research project grant (RPG) success rate among all NIH
institutes and centers, and is significantly lower than the overall NIH
RPG success rate of 18.7%.\13\ To further this vital work, we are
requesting a total of at least $199.755 million for the National
Institute of Nursing Research.
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\10\ Schnall, R. (2020) National Institute of Health (NIH) funding
patterns in Schools of Nursing: Who is funding nursing science research
and who is conducting research at Schools of Nursing? Journal of
Professional Nursing, 36(1), 34-41. Retrieved from https://
www.sciencedirect.com/science/article/pii/S8755722319301164?via=ihub#.
\11\ National Institutes of Health, National Institute of Nursing
Research. The NINR Strategic Plan: Advancing Science, Improving Lives.
Retrieved from: https://www.ninr.nih.gov/sites/www.ninr.nih.gov/files/
NINR_StratPlan2016_reduced.pdf.
\12\ Federal Funding of Nursing Research by the National Institutes
of Health (NIH): 1993-2017 Kiely, Daniel P. et al. (2019) Page 9.
Retrieved from: https://www.nursingoutlook.org/article/S0029-
6554(19)30315-X/addons.
\13\ Ibid.
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From the classroom to the frontlines, nurses and nursing students
are integral members of the healthcare team. Strong investments in
Title VIII Nursing Workforce Development Programs and NINR have a
direct impact on sustaining pathways into nursing and patient access to
high-quality, evidence-based care in all communities across the nation.
During these unprecedented times, AACN respectfully requests bold
support in FY 2022 of at least $530 million for the Title VIII Nursing
Workforce Development Programs and at least $199.755 million for the
National Institute of Nursing Research. Together, we can ensure that
such investments promote innovation and improve health and healthcare
in America.
[This statement was submitted by Susan Bakewell-Sachs, PhD, RN,
FAAN, Board Chair, American Association of Colleges of Nursing.]
______
Prepared Statement of the American Association of Colleges of
Osteopathic Medicine
The American Association of Colleges of Osteopathic Medicine
(AACOM) strongly supports fiscal year (FY) 2022 funding for the
following programs important to the osteopathic medical education (OME)
community:
--$46.1 billion for the National Institutes of Health (NIH)
--$6.1 billion for the Teaching Health Centers Graduate Medical
Education (THCGME) Program
--$9.2 billion for discretionary Health Resources and Services
Administration (HRSA)
--$980 million for the Title VII health professions workforce
development programs under the Public Health Service Act
--Permanent funding for the Rural Residency Planning and Development
(RRPD) Program
--$130 million for discretionary National Health Service Corps (NHSC)
Scholarship and Loan Repayment programs
--$67 million for the Area Health Education Center (AHEC) Program
--$125 million for the Primary Care Training and Enhancement (PCTE)
Program
--$500 million for the Agency for Healthcare Research and Quality
(AHRQ)
--$10 billion for the Centers for Disease Control and Prevention
(CDC)
AACOM leads and advocates for the full continuum of OME to improve
the health of the public. Founded in 1898 to support and assist the
nation's osteopathic medical schools, AACOM represents all 37
accredited colleges of osteopathic medicine--educating nearly 31,000
future physicians, 25 percent of all U.S. medical students--at 58
teaching locations in 33 U.S. states, as well as osteopathic graduate
medical education professionals and trainees at U.S. medical centers,
hospitals, clinics, and health systems.
Osteopathic medicine plays an essential role in our nation's
healthcare delivery system and is a growing field. According to recent
data, AACOM received more than 28,000 applicants to osteopathic medical
school for the 2020-2021 application cycle, representing a 19.26
percent increase over the previous year. Osteopathic physicians focus
on treating the whole person, and over half practice in the primary
care specialties of family medicine, internal medicine, and pediatrics.
Importantly, osteopathic medical students receive 200 hours of
additional training in osteopathic manipulative treatment, a hands-on
treatment used to diagnose and treat illness and injury, giving us a
unique voice and perspective in the medical community. However, the
clinician workforce and scientists at osteopathic medical schools are
underutilized in NIH funding opportunities and underrepresented on NIH
Advisory Councils and standing study sections.
AACOM urges Congress to overcome the historic bias against
osteopathic medical research by expanding representation on NIH
Councils and study sections and increasing NIH funding. Expanding
engagement by osteopathic medical schools and professionals will result
in innovative healthcare delivery solutions, expanded evidence-based
research, and broader community-focused treatment models. OME
investment will advance research in primary care, prevention, and
treatment and employ an already diverse physician population that is
enriched in socioeconomically disadvantaged rural communities. AACOM's
request of $46.1 billion for NIH will support scientific advancements
that incorporate the osteopathic philosophy and strengthen the United
States position as the world's research and development leader.
OME has a proven history of establishing educational programs for
medical students and residents that target the healthcare needs of
rural and underserved populations. With health disparities on the rise,
and worsening because of the COVID-19 pandemic, we are proud to help
make healthcare access more equitable for all our country's patients
and communities. In fact, recent AACOM data show that 40 percent of
graduating 2019-2020 osteopathic medical students plan to practice in a
medically underserved or health shortage area; of those, 45 percent
plan to practice in a rural community.
AACOM expresses its strong support for $6.1 billion for the THCGME
Program and our desire for permanent, mandatory funding for this
critical program. According to HRSA, physicians who train in Teaching
Health Centers (THCs) are three times more likely to work in such
centers and more than twice as likely to work in underserved areas. The
continuation of this program is critical to addressing primary care
physician workforce shortages and delivering health care services to
underserved communities. AACOM is pleased that Congress supported this
highly successful bipartisan program through the Consolidated
Appropriations Act, 2021 and American Rescue Plan Act of 2021, which
extended the THCGME Program through fiscal year 2023 and provided
additional funding. However, new funding is needed to extend the THCGME
Program to meet economic challenges caused by the COVID-19 pandemic and
support additional expansion to underserved areas that face existing
shortages of primary care physicians.
AACOM appreciates the opportunity to submit its views and looks
forward to continuing to work with the Subcommittee on these important
matters.
[This statement was submitted by Robert A. Cain, DO, FACOI, FAODME,
President and Chief Executive Officer, American Association of Colleges
of
Osteopathic Medicine.]
______
Prepared Statement of the American Association of Immunologists
The American Association of Immunologists (AAI), the nation's
largest professional association of research scientists and physicians
who are dedicated to understanding the immune system through basic,
translational, and clinical research, respectfully submits this
testimony regarding fiscal year (FY) 2022 appropriations for the
National Institutes of Health (NIH). AAI recommends an appropriation of
$52 billion for NIH for FY 2022, including at least $46.1 billion for
the regular NIH budget, to enable the agency to fund needed research to
prevent dangerous infectious diseases and treat debilitating chronic
illnesses, support meritorious scientists at all career stages, and
ensure a robust research enterprise that maintains U.S. preeminence in
biomedical science and innovation. Because the COVID-19 pandemic has
posed difficult challenges, including lab closures and other
interruptions, to many biomedical (particularly early career)
scientists, NIH needs, and AAI strongly supports, an infusion of
additional funding that would likely be considered outside of the
annual appropriations process.
AAI also supports the appropriation of substantial funding to
launch the newly proposed Advanced Research Projects Agency for Health
(ARPA-H). While AAI is enthusiastic about ARPA-H's potential, we
believe that any funding provided must supplement, and not supplant,
the NIH regular budget, and that this new agency must enhance, and not
interfere with, NIH's historic commitment to funding basic research.
AAI also urges that NIH solicit stakeholder input to help answer many
outstanding questions, including whether existing programs--and which
research areas--will be integrated into ARPA-H. Finally, AAI believes
that funding for ARPA-H projects should be provided for longer than
three years to ensure sufficient time for the kind of innovative,
collaborative, and transformative research that is contemplated.
illustrating the importance of understanding the immune system: covid-
19
The COVID-19 pandemic has highlighted both the importance, and high
stakes, of biomedical research. Our lives, health, security, and
prosperity depend on scientific understanding and advances. What felt
remote to many people--scientists toiling away unseen in their
laboratories--has become urgent, everyday news. The surge of interest
in immunology--and scientists' ability to meet this historic moment--
have been bright spots in an otherwise tragic, painful, and
unprecedented year, and rapidly developed vaccines to prevent COVID-19
infection have been a historic success story.
But SARS-CoV-2, the virus that causes COVID-19, continues to
mutate, giving rise to new variants. We know that this is what viruses
do, and we know that this is what our immune systems must be primed to
fight. Despite excellent news on the vaccine front, the regular
appearance of new variants, our paucity of therapeutics for those who
contract COVID-19, and our lack of understanding of, and treatments
for, Post-Acute Sequelae of SARS-CoV-2 infection (PASC, or ``long
COVID'') all render as premature any declaration of victory. We must
continue to invest robustly not only in a deeper understanding of how
the immune system responds to this virus and these vaccines, but also
in research devoted to the basic understanding of the immune system.
Such research will help us both emerge from this pandemic and prevent--
and more rapidly extinguish--any future ones.
But the study of immunology is about much more than infectious
diseases. Research on the immune system has taught us how to harness it
to kill malignant tumors and treat other chronic diseases
(immunotherapy); how it prevents or exacerbates chronic conditions such
as Alzheimer's, multiple sclerosis, and cardio-vascular disease; how it
enables--or prevents--the successful transplantation of a lifesaving
organ; and how it can protect its host from (natural or man-made)
agents of bioterrorism.
how basic immunology research led to rapid approval of vaccines and
treatments for covid-19
In this pandemic era, there is no better way to illustrate the
importance of a long-term commitment to biomedical research, and
specifically to immunological research, than to describe how science
achieved the near-impossible: the successful testing, manufacture, and
distribution of multiple, highly effective, and safe vaccines against
COVID-19 in less than a year after the identification of the causative
agent. The development of both treatments and vaccines for SARS-CoV-2
infection and COVID-19 was a result of decades of basic research, much
of which was funded by, or performed at, NIH. This work includes
understanding the virus, identifying good antigens for a vaccine, and
defining immune system responses to infection.
SARS-CoV-2 is a member of the beta-coronavirus family responsible
for two other recent outbreaks, SARS-CoV-1 (2003) and MERS (2012) and
is related to the coronaviruses that cause 15-30% of common colds. More
than 50 years of research on this virus family has allowed us to
understand key portions of the viral genome and viral life cycle, as
well as the importance of the spike protein for infection. While work
at NIH's National Institute of Allergy and Infectious Diseases' Vaccine
Research Center identified how to manipulate the spike protein so it
could be used in a vaccine, work on other infectious diseases and some
cancers facilitated the implementation of the mRNA platform into a
ready-to-use state. After developing mRNA vaccines for 10-15 years,
scientists launched some of the first clinical trials using the mRNA
platform against Zika virus and influenza. As a result, the platform
was ready to be quickly adapted to target the SARS-CoV-2 spike protein.
In other work, scientists rapidly characterized immune responses in
people who experienced SARS-CoV-2 infection. Patients with poor
outcomes had over exuberant immune responses; blocking these responses
with steroids improved survival. Immunologists also identified several
immune molecules that are at too high levels (e.g., IL-6) or too low
levels (e.g., interferon). Work is ongoing to understand what
protective immunity looks like, including the types of antibodies and
cellular immunity that prevent reinfection and characterize immunity
after vaccination. These studies will support the generation of booster
vaccines and give us insight into how well current vaccines protect
against new viral variants.
Finally, because of this longstanding research into coronaviruses,
scientists can reasonably infer how long protective immunity will last
following infection with, or vaccination against, SARS-CoV-2, giving
the public confidence to resume their daily activities while providing
the scientific community with a needed window in which to develop
booster vaccines that will protect against circulating viral variants.
vaccines against other infectious diseases and newly emerging threats
Vaccines remain the most effective method of disease prevention.
Vaccination against more than two dozen viral, bacterial, and fungal
diseases prevents about 2.5 million deaths globally and reduces the
severity of illness for millions of people annually.\1\ As the world's
population grows and as travel enables people to become even more
interconnected, we will continue to experience the very real threat of
new emerging pathogens causing a deadly pandemic. Lessons we learn from
developing and administering vaccines against SARS-CoV-2 will be
essential to protecting against other infectious diseases and a future
pandemic.
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\1\ https://www.who.int/immunization/global_vaccine_action_plan/
GVAP_doc_2011_2020/en/.
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Last year, I testified that there was no approved vaccine against
SARS-CoV-2, but that NIH-funded research conducted on other causative
pathogens in recent epidemics, including SARS and MERS, had made
possible the rapid development of vaccine candidates against SARS-CoV-
2.\2\ Since then, three vaccine candidates have received an Emergency
Use Authorization (EUA) from the Food and Drug Administration (FDA),
and two will be considered soon for licensure.\3\ AAI is confident that
previously conducted research, together with new research now being
urgently pursued, will result in additional vaccines and treatments to
prevent and/or reduce both the lethality of, and long-term symptoms
caused by, COVID-19.
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\2\ https://www.niaid.nih.gov/diseases-conditions/coronaviruses.
\3\ https://www.fda.gov/emergency-preparedness-and-response/
coronavirus-disease-2019-covid-19/covid-19-vaccines; https://
www.pfizer.com/news/press-release/press-release-detail/pfizer-and-
biontech-initiate-rolling-submission-biologics; https://
investors.modernatx.com/news-releases/news-release-details/moderna-
announces-initiation-rolling-submission-biologics.
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nih: the essential role of the nation's leading biomedical research
agency
As the nation's major funding agency for biomedical research, NIH
is an indispensable scientific leader both in the U.S. and around the
world. The steward of nearly $43 billion in federal funds, NIH
distributes more than 80% of its budget via a competitive peer review
process to more than 300,000 researchers at 2,500 universities,
medical schools, and other research institutions across the nation and
internationally.\4\ About 10% of its budget supports 6,000 additional
researchers and clinicians who work at NIH facilities around the
country.\5\ By funding these researchers and laboratories, NIH not only
advances scientific achievement, it also helps strengthen state and
local economies; in 2020, NIH funding supported more than 536,000 jobs
and accounted for $91 billion in economic activity across the U.S.\6\
The basic research that NIH funds is an essential and irreplaceable
part of the biomedical research pipeline; data show that it contributed
to all 210 of the new drugs approved by the FDA from 2010-2016.\7\
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\4\ https://www.nih.gov/about-nih/what-we-do/budget; https://
report.nih.gov/award/index.cfm.
\5\ https://irp.nih.gov/about-us/research-campus-locations.
\6\ https://www.unitedformedicalresearch.org/wp-content/uploads/
2021/03/NIHs-Role-in-Sustaining-the-U.S.-Economy-FINAL-3.23.21.pdf.
\7\ https://directorsblog.nih.gov/2018/02/27/basic-research-
building-a-firm-foundation-for-biomedicine/.
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NIH plays an essential role in responding to emerging health
threats; throughout the coronavirus pandemic, NIH leaders and
researchers have provided critically needed scientific advice to the
President, Congress, and the American public while also utilizing their
expertise to help develop a vaccine and treatments. NIH also regularly
apprises our nation's leaders about other scientific advancements and
research priorities, and its unparalleled peer review process fosters
the wise distribution of taxpayer dollars.
continued funding increases needed to rebuild and grow nih capacity
Leadership by this subcommittee has helped Congress provide
generous increases to the NIH budget over the last six years. Although
these increases have helped restore much of the purchasing power that
NIH lost after years of inadequate budgets and erosion from biomedical
research inflation, NIH's purchasing power remains below its 2003 peak
funding level. Meaningful budget growth will help close this gap and
allow NIH to invest not just in important research priorities across
its Institutes and Centers, but also in the research workforce. While
NIH should continue to support meritorious senior scientists, it is
urgent to ensure that we will have sufficient mid- and early career
scientists ready to take on increasingly complex scientific challenges.
We must provide NIH with the resources needed to provide a dynamic
research environment that allows for the training, development, and
support of our next generation of researchers, doctors, professors, and
inventors--and give them the confidence to pursue these careers.
conclusion
AAI greatly appreciates the subcommittee's strong support for NIH
and urges a budget for NIH of $52 billion for FY 2022. Within that, AAI
recommends an appropriation of at least $46.1 billion for the regular
NIH budget to help the agency grow its ability to invest in critically
important research, including vital immunologic research, support
meritorious scientists at all career stages, and help scientists
discover new ways to prevent, treat, and cure deadly and debilitating
diseases that afflict people in the U.S. and throughout the world. AAI
also urges a substantial appropriation to launch the new ARPA-H, which
could greatly advance human immunology at a time in our history when
pressing public health needs, and unprecedented scientific
opportunities, have converged.
[This statement was submitted by Ross M. Kedl, Ph.D., Chair of the
Committee on Public Affairs, American Association of Immunologists.]
______
Prepared Statement of the American Association of Neuromuscular &
Electrodiagnostic Medicine
fiscal year 2022 recommendations
_______________________________________________________________________
--Please continue to provide meaningful, annual funding increases for
healthcare fraud and abuse programs at the Centers for Medicare
and Medicaid Services (CMS) while allowing for flexibility and
innovation to address emerging challenges.
--Please continue to include timely recommendations in the Committee
Report accompanying the annual Labor-Health and Human Services-
Education (LHHS) Appropriations Bill encouraging CMS to take
substantive action to systematically address fraud, abuse, and
the quality of patient care in electrodiagnostic (EDX)
medicine.
--Please provide the National Institutes of Health (NIH) with $46.1
billion in discretionary funding, an increase of $3.2 billion
over FY 2021. Please also provide proportional increases for
various NIH Institutes and Centers, including the National
Institute of Arthritis and Musculoskeletal and Skin Diseases
(NIAMS), the National Institute of Allergy and Infectious
Diseases (NIAID), and the National Institute of Neurological
Disorders and Stroke (NINDS).
--Please support adequate funding to establish the new Advanced
Research Projects Agency for Health (ARPA-H) at NIH to
facilitate robust and swift scientific progress on a variety of
neuromuscular conditions.
_______________________________________________________________________
Chairwoman Murray, Ranking Member Blunt, and distinguished Members
of the Subcommittee, thank you for the opportunity to present the views
of the American Association of Neuromuscular & Electrodiagnostic
Medicine (AANEM) during the consideration of FY 2022 L-HHS
appropriations. First and foremost, thank you for the ongoing
investment in medical research and patient care programs. Please
continue this investment in FY 2022.
In regards to fraud and abuse, the challenges and opportunities
that I will review today are not unique to AANEM, but impact a variety
of medical professional societies and patient communities who rely on
proper EDX testing. My comments are provided in the interest of
spotlighting serious issues that continue to undermine patient care and
waste federal healthcare resources, while advancing policy tools to
efficiently and effectively address these issues. In this regard,
please consider the AANEM a resource moving forward. Thank you again
for this important opportunity.
about aanem
AANEM is a nonprofit membership association dedicated to the
advancement of neuromuscular, musculoskeletal, and EDX medicine. Our
members--primarily neurologists and physical medicine and
rehabilitation (PMR) physicians--are joined by allied health
professionals and PhD researchers working to improve the quality of
medical care provided to patients with muscle and nerve disorders.
Founded in 1953, AANEM currently has over 5,400 members across the
country. Our mission is to improve quality of patient care and advance
the science of neuromuscular (NM) diseases and EDX medicine by serving
physicians and allied health professionals who care for those with
muscle and nerve disorders. Our members are dedicated to diagnosing and
managing a variety of nerve and muscle disorders including, but not
limited to, amyotrophic lateral sclerosis, muscular dystrophies, and
neuropathies, as well as more common conditions, such as pinched nerves
and carpal tunnel syndrome.
about edx medicine
When functioning properly, nerves send electrical impulses to the
muscles to activate them. A nerve disorder means that signals are not
getting through like they should. A muscle disorder means that muscles
aren't responding to the signals correctly. To determine whether your
nerves and muscles are working properly, your doctor may recommend you
have EDX testing, which generally includes both a nerve conduction
study (NCS) and needle electromyography (EMG) testing. Other tests may
include imaging, genetic testing, biopsies, biochemical tests, and
strength testing. The results of these tests help your doctor diagnose
your condition and determine the best treatment.
NCS.--These studies evaluate how quickly and efficiently electrical
impulse move through the nervous system. While it may sound straight-
forward, proper testing requires sophisticated equipment, an
understanding of the patient's health history, and, most importantly,
the ability to design/perform the study and interpret the results.
EMG.--These tests evaluate muscles and nerves through the use of
electrodes under the skin. Since the procedure is invasive and highly
technical, it is considered to be the practice of medicine by the
American Medical Association, requiring training, study, and experience
to ensure patient safety and testing efficacy.
about edx fraud and abuse
In 2014, the HHS OIG published a report entitled, Questionable
Billing for Medicare Electrodiagnostic Tests, which found roughly $140
million in suspicious activity annually. But experience tells us that
this is just the tip of the iceberg. And the toll of patient suffering
and hardship as the result of fraudulent EDX testing is incalculable.
Unfortunately, since this report was released, the situation has
deteriorated rather than improved. Our members have anecdotally noted
an increase in fraud activity (both through solicitations and by re-
testing patients that were victims of improperly performed tests),
which appears to be supported by CMS utilization data. CMS revised the
EDX codes in 2013 which has actually made it harder to identify
systematic fraud and abuse in this area. Bad actors are aware of the
gaps in the current CMS regulatory and enforcement framework that
create unique blind spots for EDX testing, and this deficiency
continues to be exploited with many criminal endeavors operating in the
open for years as sham professional service providers (the small number
that are caught and convicted annually has not served as a deterrent).
To be clear, the victims continue to be the patients that are
improperly tested, subjected to a battery of studies, and over-billed,
with no intention of receiving an accurate diagnosis or who were never
in need of testing in the first place.
current opportunities
CMS, the FBI, and the HHS OIG have been doing tremendous work to
root out fraud and abuse in EDX medicine, but these dedicated public
servants are limited by the constraints of the current pay-and-chase
model. Additional resources for ongoing CMS efforts to address
healthcare fraud and abuse will facilitate incremental improvements and
further protect patients, but modernization is needed as well. Over
recent appropriations cycles, Congress has called on CMS to work with
the EDX community on innovative solutions that could better identify
bad actors conducting EDX testing or simply prevent payments for
improper studies before they are made. Please continue to work with CMS
through the FY 2022 appropriations process to recommend greater
community collaboration and to encourage meaningful and timely progress
in the area of EDX fraud and abuse.
statement of aanem member dr. vince tranchitella
New NCS codes became effective on January 1, 2013. The new codes
were developed as a direct response to fraudulent activity that
resulted in the exponentially increased billing for NCSs.
Unfortunately, the new NCS codes failed to have the desired effect. My
most recent case involved 56 EDX studies, all of which were performed
AFTER the NCS codes were changed in 2013, and every single one of the
reports were deemed so far below the standard of care that none of them
could be considered a reliable representation of the true medical
status of the patients who received those tests. Therefore, none of
those tests should have been billed or reimbursed.
recent examples from dr. peter grant
EDX fraud not only wastes healthcare dollars, but, more
importantly, the quality of patient care suffers severely. As an
example, a recent case in which I testified in Houston working for the
FBI and the US Attorney's Office, many patients' insurance companies
were being billed more than $30,000 for a study that should cost $800
to $1200. Of note, when a detailed review was performed, more than 85%
of the diagnoses arrived at with these fraudulent studies were
incorrect and unreliable. These inappropriate and inaccurate studies
did not help these patients in finding appropriate treatments or
solutions to their medical problems. In fact, they often sent the
patients down costly and ineffective paths of treatment. In this case
alone the perpetrators were convicted of EDX fraud totaling nearly $5
million.
As is invariably the case with mobile EDX laboratories, quality of
care suffers while costs skyrocket and the real losers are,
unfortunately, the patients. In a case I had in California, a 47 year
old man had a mobile EDX study done that cost him (and his insurance
company) more than $7,500 and told him his symptoms were from a
``pinched nerve in his leg''. When I performed the correct study
(charging about $750) I found his true diagnosis to be ALS (or Lou
Gehrig's disease).
[This statement was submitted by Peter A. Grant, MD, EDX, Fraud and
Abuse Consultant for FBI/OIG, American Association of Neuromuscular &
Electrodiagnostic Medicine.]
______
Prepared Statement of the American Association of University Professors
Dear esteemed Members of Congress:
The American Association of University Professors (AAUP) is the
oldest organization of its kind, representing faculty and graduate
employees in institutions of higher education. Since its founding in
1915, the AAUP has been an active and influential voice in higher
education. The AAUP defines and develops fundamental professional
values, standards, and procedures for higher education; advances the
rights of academics, particularly as those rights pertain to academic
freedom and shared governance; and promotes the interests of higher
education teaching and research.
On behalf of all faculty, and our chapters across hundreds of
institutions, we write to thank you for your historic investments in
higher education over the course of the past year. Across the country,
funding provided by the CARES Act and subsequent COVID-19 relief bills
have stopped the worst financial impacts from hitting our campus
communities. However, as appreciated as the unprecedented $135 billion
has been, faculty and staff have not shared in all the benefits, to the
detriment of the student experience. According to a survey we recently
ran of faculty senate chairs, 10 percent of institutions had laid off
tenured faculty and 28 percent had laid off contingent faculty in the
past year,\1\ despite the influx of federal funds that explicitly said
that they could be used to meet payroll budget gaps. Faculty working
conditions are student learning conditions. To us, it is clear that our
institutions need sustained, increased funding to invest more in the
people and infrastructure that make them run.
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\1\ https://www.aaup.org/report/survey-data-impact-pandemic-shared-
governance.
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We are pleased to see the historic levels of funding proposed in
the American Families Plan and the President's FY22 budget. This
funding makes meaningful progress towards our call for a New Deal for
higher education,\2\ which calls for free college, faculty and staff
job security, and student debt cancellation. These planks of our New
Deal platform will provide institutions the resources they need to
better foster innovation and ensure high quality instruction. Beyond
that, in a time of political division and heightened social tension,
open access to a college education might also help us strengthen civic
engagement and advance racial and economic justice. However, as
ambitious and appreciated as the President's proposals have been, in
some ways they fall short of what students need--and don't go far
enough to equitably fund our institutions.
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\2\ https://newdealforhighered.org/.
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The AAUP recommends that the Appropriations Committee prioritize
the following to better meet the needs of faculty and students:
1. Double the Pell Grant, the purchasing power of which has
fallen to less than a third of the annual cost of tuition at
the average public institution. More than a thousand
organizations have called on Congress to increase Pell Grant
funding dramatically, and that call seems more urgent than ever
given increased student need during the pandemic. Furthermore,
we strongly encourage you to maintain the Pell Grant reserve,
and not rescind it to fund other programs within the Labor-HHS-
Education budget.
2. Increase funding for programs that support students of color,
non-traditional students, and low-income students, such as but
not limited to Title III funds to minority serving
institutions, TRIO, SEOG, work study, and CCAMPIS. These
programs ought to see more generous funding to help close
equity gaps between non-traditional students and their peers,
and to begin to address historic underfunding that minority-
serving institutions have faced.
3. Increase funding to scientific research programs, which are a
significant source of funding to support graduate students in
their pursuit of knowledge and a degree. The cutting-edge
academic and scientific discoveries made by researchers at
American institutions makes our higher education system one of
the most respected in the world. Many of these discoveries lead
to robust partnerships with private industry that result in job
creation and economic growth. And, the scientific breakthroughs
of the past year make a clear case for increased funding for
broad and exploratory research.
4. Create a federal-state partnership to make college free, so
that any qualified student might pursue an associate's or
bachelor's degree at the institution of their choice. Congress
should also consider how to increase funding to private
institutions so that they too can offer reduced costs, such as
Title III programs and noting in report language that states
may use these funds for student grant aid to subsidize the cost
of attendance at private institutions in their home state.
5. As a condition of this new funding, it ought to protect
faculty and staff job security by setting a baseline of support
for workers. Gig work and the exploitation of contingent
faculty erodes the foundations of what makes American higher
education so respected internationally. Beyond supporting an
increase in the share of faculty on the tenure track, where
applicable, positions on college campuses should provide a
guarantee of good pay, continuity of employment, and parity in
wages and benefits between full and part time positions.
Institutions should work as much as possible to convert
existing short-term contracts with employees to longer-term or
tenure-track appointments.
6. Promote shared governance, by making clear in bill and report
language that federal funding to institutions and states in the
aftermath of the COVID-19 pandemic ought to maintain
instructional spending levels and faculty jobs, ahead of
administrative costs or debt financing. Furthermore, faculty
and staff must have meaningful input when administration seek
to cut costs in moments of financial uncertainty.
We would again like to thank you for your generous and historic
funding to meet the needs of students and institutions of higher
education during the pandemic. We look forward to working with you to
help our country recover from the pandemic, strengthen our communities
and civil society, and create thousands more good-paying jobs on campus
in the process.
[This statement was submitted by Kaitlyn Vitez, Government
Relations Officer, and John McNay, Government Relations Committee
Chair, American Association of University Professors.]
______
Prepared Statement of the American College of Cardiology
The American College of Cardiology (ACC) commends Congress for
boosting funding for the National Institutes of Health (NIH) and
Centers for Disease Control and Prevention (CDC) in FY21. To continue
this important progress in FY22 and beyond, and to adequately fund
public health and research infrastructure in response to the COVID-19
pandemic, ACC urges members of Congress to appropriate the following
funds toward agencies doing vital work in cardiovascular disease (CVD)
treatment and prevention: $3.963 billion for the National Heart Lung &
Blood Institute (NHLBI) to increase the NIH's purchasing power and
preserve U.S. leadership in research; $160 million toward the CDC's
Division for Heart Disease and Stroke Prevention to strengthen heart
disease prevention efforts at state and local levels, $10 million
toward CDC's Million Hearts to prevent 1 million heart attacks and
strokes, $46.7 million toward CDC's WISEWOMAN to help uninsured or
under-insured women prevent or control heart disease, $10 million
toward CDC congenital heart research to study its effects over the
patient's lifespan, and $310 million toward CDC's Office on Smoking and
Health to maintain the program's cost-effective tobacco control
efforts. ACC asks for the inclusion of report language promoting
valvular heart disease research at the NHLBI since clinical predictors
of patients at higher risk of sudden cardiac death are still lacking.
ACC envisions a world where innovation and knowledge optimize
cardiovascular care and outcomes. As the professional home for the
entire cardiovascular team, the mission of the College and its more
than 52,000 members is to transform cardiovascular care and improve
heart health. The ACC bestows credentials upon cardiovascular
professionals who meet stringent qualifications and leads in the
formation of health policy, standards and guidelines. The College also
provides professional medical education, disseminates cardiovascular
research through its world-renowned JACC Journals, operates national
registries to measure and improve care, and offers cardiovascular
accreditation to hospitals and institutions.
CVD, a class of diseases that includes diseased blood vessels,
structural problems, and blood clots, continues to be the leading cause
of death among men and women in the United States and is responsible
for 1 in every 4 deaths.\1\ More than 92 million Americans currently
suffer from some form of CVD--nearly one-third of the population--but
it remains one of the most underfunded deadly diseases, as the NIH only
invests 4 percent of its research dollars on heart research.\2\ The
heart disease death rate has continued to drop since the 1970s \3\ due
to scientific advances and improved heart medications and procedures--
but to meet the challenges of an aging population, rising obesity rates
and the long-term complications of COVID-19 and patients with heart
disease, the NIH must maintain its place at the forefront of medical
innovation for years to come. The NHLBI, the third-largest institute at
the NIH, conducts research related to heart, blood vessel, lung, and
blood diseases, generating drugs for lowering cholesterol, controlling
blood pressure, and dissolving blood clots. These biomedical
advancements have contributed to a 71 percent \4\ decrease in death
rates due to cardiovascular disease.
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\1\ Heart Disease Facts; Centers for Disease Control and
Prevention. https://www.cdc.gov/heartdisease/facts.htm.
\2\ National Coalition for Heart and Stroke Research; American
Heart Association. http://www.heart.org/HEARTORG/Advocate/
IssuesandCampaigns/Research/National-Coalition-for-Heart-and-Stroke-
Research_UCM_428347_Article.jsp#.Wt4h-m4vypo.
\3\ Decline in Cardiovascular Mortality; National Library of
Medicine. https://www.ncbi.nlm.
nih.gov/pmc/articles/PMC5268076/.
\4\ HHS/NIH/NHLBI FY2017 Congressional Justification Report;
https://www.nhlbi.nih.gov/sites/default/files/media/docs/
Final%20NHLBI%202017%20CJ_R508_v1_0.pdf.
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Preventing and treating CVD applies to long-term COVID-19 patients.
Recent studies have shown that cardiovascular consequences of COVID-19
extend beyond initial infection, and many COVID-19 survivors experience
some type of heart damage, even if they did not have underlying heart
disease and were never hospitalized. Imaging tests taken months after
recovery from COVID-19 have shown lasting damage to the heart muscle in
people who experienced only mild symptoms, which may increase the risk
of heart failure or other heart complications in the future.\5\ As CVD
continues to be the country's leading cause of death while COVID-19
infections also present risks to cardiovascular health, we recommend
the NHLBI be funded at $3.965 billion to support research on COVID-19
by leveraging existing NIH-funded studies and infrastructure, and to
maintain current activities and investment toward new research and
emerging technologies related to heart disease.
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\5\ https://www.mayoclinic.org/diseases-conditions/coronavirus/in-
depth/coronavirus-long-term-effects/art-20490351.
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More than 11 million Americans have heart valve disease (HVD) which
involves damage to one or more of the heart's valves and leads to
disrupted blood flow by not opening or closing properly.\6\ HVD can
lead to major complications and some people with HVD do not always have
symptoms, even if their disease is severe. ACC recommends that the
NHLBI address gaps in understanding heart valve disease to better
recognize indicators of patients at higher risk of sudden cardiac
death. We propose report language to better understand and develop
guidelines for treatment of high-risk patients: The committee
recognizes that heart valve disease involves damage to one or more of
the heart's valves, and symptoms can be difficult to detect and lead to
major complications. The committee encourages the NHLBI to expand
research on valvular disease to better understand and develop
guidelines for treatment of high-risk patients by using precision
medicine and advanced technological imaging to generate data,
identifying and developing a cohort of individuals with valvular heart
disease and available data, and corroborating data generated through
clinical trials to develop a prediction model to identify patients at
high risk for sudden cardiac arrest or sudden cardiac death from
valvular disease.
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\6\ Heart Valve Disease Awareness Day; https://
www.valvediseaseday.org/the-issue/.
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The CDC plays a vital role in protecting public health through
healthy lifestyle promotion and educational activities designed to curb
non-infectious diseases such as obesity, diabetes, stroke, and heart
disease. The CDC Division for Heart Disease and Stroke Prevention
supports efforts to improve cardiovascular health by promoting healthy
lifestyles and behaviors, healthy environments, and access to early
detection and affordable treatment. The division engages with local and
state health departments, and a variety of other partners, to provide
funding and resources, conduct research, track risk factors, and
evaluate current programs and policies relating to heart disease. We
recommend that the CDC Division for Heart Disease and Stroke Prevention
be funded at $160 million to explore the intersections between COVID-19
and cardiovascular disease; build or enhance critical data
infrastructure; and expand current work in priority areas through new
partnerships, programs, and projects, all focused on eliminating
disparities in health outcomes.
Launched in 2012 and co-led by the CDC and the Centers for Medicare
and Medicaid Services, the Million Hearts program coordinates and
enhances CVD prevention activities with the objective of preventing 1
million heart attacks and strokes in 5 years. The initiative aims to
achieve this goal by encouraging the public to lead a healthy and
active lifestyle, as well as improving medication adherence for aspirin
and other medications to manage blood pressure, cholesterol, and
smoking cessation. New funding would frontload the success of Million
Hearts by facilitating extensive partner input into the design of the
next five-year phase; integration of insights gleaned from the
pandemic, including and especially the inequities further exposed by
COVID-19; and analysis of the individual, community, and healthcare
actions with the greatest impact on cardiovascular health for all. We
recommend that Million Hearts be funded at $10 million to enhance
efforts preventing heart attacks and strokes.
CDC's WISEWOMAN initiative provides more than 165,000 under-
insured, low-income women ages 40-64 with services to help reduce heart
disease and stroke risk factors. Heart disease ranks as the leading
cause of death for women. Only 1 in 5 \7\ women believes heart disease
is her greatest health threat, and 11 percent \8\ of women remain
uninsured. We recommend that $46.7 million be allocated for WISEWOMAN
to provide preventive health services, referrals to local health care
providers, lifestyle programs, and counseling in all 50 states.
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\7\ WISEWOMAN; Centers for Disease Control and Prevention. https://
www.cdc.gov/
wisewoman/.
\8\ Women's Health Insurance Coverage; The Henry J. Kaiser Family
Foundation. http://kff.org/womens-health-policy/fact-sheet/womens-
health-insurance-coverage-fact-sheet/.
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Congenital heart disease (CHD), a life-long consequence of a
structural abnormality of the heart present at birth, is the number one
birth defect in the U.S. While the diagnosis and treatment of CHD has
greatly improved over the years, most patients with complex heart
defects need special care throughout their lives, and only by expanding
research opportunities can we fully understand the effects of CHD
across the lifespan. As authorized by the Congenital Heart Futures
Reauthorization Act of 2017, we recommend that the CDC National Center
for Birth Defects and Developmental Disabilities be funded at $10
million for enhanced CHD surveillance and public health research.
Programs within CDC's Office on Smoking and Health (OSH) work to
prevent smoking among young adults and eliminate tobacco-related health
disparities in different population groups. From 2012-2018, the CDC
estimates that more than 16.4 million people who smoke have attempted
to quit and about 1 million have successfully quit because of the OSH
Tips from Former Smokers campaign.\9\ While these programs have proven
effective in tobacco cessation and prevention, more than 480,000 people
still die every year from causes attributable to smoking, and 33
percent of those deaths stem from heart disease\10\ We recommend that
OSH be funded at $310 million to continue leading the nation's efforts
in preventing chronic diseases caused by tobacco use.
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\9\ CDC Office on Smoking and Health; https://www.cdc.gov/
chronicdisease/pdf/aag/osh-H.pdf.
\10\ FDA Tobacco Products Public Health Information; https://
www.fda.gov/tobacco-products/public-health-education/health-
information.
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On behalf of our members who work to prevent and treat CVD, ACC
would like to thank members of Congress for supporting medical
innovation as we continue the fight against heart disease and
understand the cardiovascular consequences of COVID-19. Stable funding
for medical research and healthy lifestyle promotion will save lives
and health care costs in the long term by creating jobs and new
technologies, which will produce billions of dollars in Medicare and
Medicaid savings over the next decade. Please help us secure robust
funding for NIH and CDC funding to protect the health of future
generations.
[This statement was submitted by Dipti Itchhaporia, MD, FACC,
President,
American College of Cardiology.]
______
Prepared Statement of the American College of Obstetricians and
Gynecologists
The American College of Obstetricians and Gynecologists (ACOG),
representing more than 60,000 physicians and partners dedicated to
advancing women's health, is pleased to offer this statement to the
Senate Committee on Appropriations, Subcommittee on Labor, Health and
Human Services, Education, and Related Agencies. We thank Chairwoman
Murray, Ranking Member Blunt, and the entire Subcommittee for this
opportunity to provide comments on some of the most important programs
to support and advance women's health in FY22. ACOG commends Congress
for making great strides to support research and data collection that
advance the health of women and families. Looking ahead, we urge you to
appropriate:
--Centers for Disease Control & Prevention (CDC): At least $10
billion for the CDC, including $102.5 million for the Safe
Motherhood Initiative, including $30 million for maternal
mortality review committees and $30 million for perinatal
quality collaboratives; and $250 million for public health
surveillance;
--National Institutes of Health (NIH): $46.1 billion for the NIH,
including at least $1.7 billion for Eunice Kennedy Shriver
National Institute of Child Health and Human Development
(NICHD), and $50 million shared evenly between CDC and NIH, for
research into firearm morbidity and mortality prevention;
--Health Resources & Services Administration (HRSA): $750 million for
the Title V Maternal and Child Health Block Grant, including
$15 million for the Alliance for Innovation on Maternal Health
(AIM) within the Special Projects of Regional and National
Significance (SPRANS); $10 million to expand depression
screening and treatment for pregnant and postpartum women; and
$5 million to establish, identify, and distribute clinicians in
maternity care health professional target areas;
--Office of Population Affairs (OPA): $737 million for the Title X
Family Planning Program; and
--$500 million for the Agency for Healthcare Research and Quality
(AHRQ).
Safe Motherhood Initiative at CDC: The United States has the
highest rate of maternal mortality and severe morbidity of any
industrialized country. The Safe Motherhood Initiative at CDC works
with state health departments to collect information on pregnancy-
related deaths, supports maternal mortality review committees (MMRCs),
tracks preterm births, and improves maternal outcomes through perinatal
quality collaboratives. Important strides have been made as nearly
every state either currently has, is in the process of implementing, or
is making plans to develop a state MMRC. In addition, the CDC currently
supports 13 perinatal quality collaboratives (PQCs), often considered
the implementation arm of MMRCs. We must continue to build on this
progress and improve maternal health outcomes. ACOG requests that you
fund the Safe Motherhood Initiative at $102.5 million, including $30
million to help states expand or establish maternal mortality review
committees, and $30 million to support state-based perinatal quality
collaboratives in every state.
Women's Health Research at NIH: Women represent half of the US
population. As such, conditions and diseases that are specific to
women's health, or those that present differently in women than men,
must be a priority for federally funded research. Women's health
research is a central part of the research mission and portfolio of
NICHD, and the Institute has achieved great success in advancing
research on women's health throughout the life cycle; maternal, child,
and family health; fetal development; reproductive biology; population
health; and medical rehabilitation. With sufficient resources, NICHD
can build upon existing initiatives to produce new insights and
solutions to benefit women and families. ACOG supports an appropriation
of $46.1 billion for the NIH in FY22, including at least $1.7 billion
for NICHD.
Maternal Therapeutics at NIH: In the United States each year, more
than 4 million women give birth and more than 3 million breastfeed.
However, little is known about the effects of most drugs on the woman
and her child. In 2015 as part of the 21st Century Cures Act (Sec. 2041
of P.L. 114-255), Congress created the Task Force on Research Specific
to Pregnant Women and Lactating Women (PRGLAC) to advise the Secretary
of HHS on gaps in knowledge and research on safe and effective
therapies for pregnant and breastfeeding women. In August 2020, PRGLAC
produced an implementation plan for each of the 15 recommendations made
in 2018 to facilitate the inclusion of this population in clinical
research. ACOG supports the implementation of these recommendations
under the oversight of NICHD, working with other relevant NIH
Institutes, the CDC, and the Food and Drug Administration, and urges
Congress to express its continued support.
Title X Family Planning Program at OPA: Title X is the only federal
program dedicated to providing family planning services for people with
low incomes. For many individuals, particularly those who are low-
income, uninsured, or adolescents, Title X is essential to their
ability to affordably and confidentially obtain birth control, cancer
screenings, STI tests and other basic care. Title X has been cut or
flat-funded every year for the past decade. A significant investment is
needed to support robust restoration of the program and ensure demand
for services is met. ACOG requests $737 million for Title X in FY22 to
ensure individuals in need have access to evidence-based care. ACOG is
pleased that the Biden administration has proposed to eliminate the
2019 Title X regulations that decreased access to health care services
and disproportionately imposed barriers to care for Black, Latinx, and
Indigenous communities. ACOG urges Congress to show its strong support
for transparent, respectful, evidence-based, and comprehensive
reproductive health care by funding this critical program.
Title V Maternal and Child Health Block Grant at HRSA: The Title V
Maternal and Child Health (MCH) Block Grant at HRSA is the only federal
program that exclusively focuses on improving the health of mothers and
children. The Block Grant is a cost-effective, accountable, and
flexible funding source used to address critical, pressing, and unique
needs of maternal and child health populations in each state, territory
and jurisdiction. Notably, through the SPRANS discretionary grant, the
Block Grant supports the Alliance for Innovation on Maternal Health
(AIM) program--a program that works with states and hospital systems to
implement evidence-based best practices to improve maternal health
outcomes and reduce rates of maternal mortality and severe maternal
morbidity. For FY22, ACOG requests at least $750 million to respond to
the increased demands placed on the Block Grant, including $15 million
within SPRANS to support continued implementation of AIM.
Investing in Data and Quality at AHRQ: AHRQ is the federal agency
with the sole purpose of improving health care quality. AHRQ produces
data with the mission of making health care safer, higher quality, more
accessible, equitable, and affordable. AHRQ works with HHS and other
partners to ensure that the evidence improves patient safety. ACOG
supports $500 million for AHRQ in FY22, which reflects the FY10 funding
level for the agency adjusted for inflation and additional funding to
respond to the pandemic.
Public Health Surveillance at CDC: Uniform, accurate, and
comprehensive data is essential for addressing the rising rates of
maternal mortality and severe maternal morbidity in the US.
Unfortunately, the nation's public health data systems are antiquated,
lack interoperability and data and reporting standards, and are in dire
need of security updates. ACOG urges Congress to include a robust
investment in public health surveillance, and requests funding to be
used to modernize these systems to improve health. ACOG requests $250
million in FY22 for public health surveillance at CDC to implement
advanced technologies and train the next generation of data scientists.
Firearm Morbidity and Mortality Prevention (CDC and NIH): In 2017,
there were more than 39,000 U.S. firearm-related fatalities. Federally
funded public health research has a proven track record of reducing
public health-related deaths, whether from motor vehicle crashes,
smoking, or Sudden Infant Death Syndrome. This same approach should be
applied to increasing gun safety and reducing firearm-related injuries
and deaths, and CDC research will be as critical to that effort as it
was to these previous public health achievements. The foundation of a
public health approach is rigorous research that can accurately
quantify and describe the facets of an issue and identify opportunities
for reducing its related morbidity and mortality. For FY22, ACOG
requests $50 million, shared evenly between CDC and NIH, to conduct
public health research into firearm morbidity and mortality prevention.
Diagnosing and Treating Maternal Depression (HRSA): About 1 in 5
women experience maternal depression, and ACOG recommends that all
women be screened, yet barriers to accessing treatment remain. ACOG
commends Congress for funding Sec. 10005 of P.L. 114-255 to support the
establishment of a program at HRSA to expand depression screening and
treatment for pregnant and postpartum individuals. ACOG urges you to
fund the program at $10 million for FY22, a $5 million increase over
FY21, and increase support for the maternal mental health hotline to $5
million.
Maternity Care Target Areas (HRSA): Major pockets of the U.S. do
not have adequate access to needed maternity care, due to both a
workforce shortage and maldistribution of clinicians. This
disproportionately impacts access to obstetric care in rural
communities. Maternity care shortages threaten the ability of pregnant
individuals to receive timely prenatal and labor/delivery services.
According to the latest available data, more than half of pregnant
people living in rural areas reside more than 30-minutes by car from
the nearest hospital offering perinatal services. Further, a 2019 study
that analyzed severe maternal morbidity and mortality during childbirth
hospitalizations among rural and urban residents found that when
controlling for sociodemographic factors and clinical conditions, rural
residents had a 9 percent greater probability of severe maternal
morbidity and mortality, compared with urban residents.
The Improving Access to Maternity Care Act of 2018 (P.L. 115-320)
requires HRSA to identify maternity care health professional target
areas that are suffering from a shortage of maternity care clinicians,
including obstetrician-gynecologists and certified nurse-midwives, so
that those participating in the National Health Service Corps can be
placed in the communities most in need of their services. ACOG urges
you to fulfill the President's request for $5 million in FY22 to
implement the Improving Access to Maternity Care Act. Funding would be
used to establish criteria for and identify maternity care health
professional target areas, distribute maternity care health
professionals to those areas, and collect and publish data on the
availability and need for maternity care services within primary care
health professional shortage areas.
Thank you again for the opportunity to submit our recommendations
to the
subcommittee, and for your commitment to improving women's health.
______
Prepared Statement of the American College of Physicians
The American College of Physicians (ACP) is pleased to submit the
following statement for the record on its priorities, as funded under
the U.S. Department of Health & Human Services, for Fiscal Year (FY)
2022. ACP is the largest medical specialty organization and the second-
largest physician group in the United States. ACP members include
163,000 internal medicine physicians (internists), related
subspecialists, and medical students. Internal medicine physicians are
specialists who apply scientific knowledge and clinical expertise to
the diagnosis, treatment, and compassionate care of adults across the
spectrum from health to complex illness. As the Subcommittee begins
deliberations on appropriations for FY2022, ACP is urging funding for
the following proven programs to receive appropriations from the
Subcommittee:
--Health Resources Services Administration (HRSA), $9.2 billion;
--Title VII, Section 747, Primary Care Training and Enhancement
(PCTE), Health Resources and Services Administration (HRSA),
$71 million;
--National Health Service Corps (NHSC), $860 million in total program
funding;
--Agency for Healthcare Research and Quality (AHRQ), $500 million;
--Centers for Medicare and Medicaid Services (CMS), Program
Operations for Federal Exchanges, $296.5 million;
--Centers for Disease Control and Prevention (CDC), $10 billion,
Injury Prevention and Control, Firearm Injury and Mortality
Prevention Research, $50 million; National Center for Chronic
Disease Prevention and Health Promotion (NCCDPHP), Social
Determinants of Health program, $153 million;
--National Institutes of Health (NIH), $46.1 billion.
The United States is facing a shortage of physicians in key
specialties, notably in general internal medicine and family medicine-
the specialties that provide primary care to most adult and adolescent
patients. Current projections indicate there will be a shortage of
21,400 to 55,200 primary care physicians by 2033. Without critical
funding for vital workforce programs, this physician shortage will only
grow worse. HRSA is responsible for improving access to health-care
services for people who are uninsured, isolated or medically
vulnerable. Without critical funding for vital workforce programs, this
physician shortage will only grow worse. A strong primary care
infrastructure is an essential part of any high-functioning healthcare
system. A recent report by the National Academy of Sciences, calls on
policymakers to increase our investment in primary care as evidence
shows that it is critical for achieving health care's quadruple aim
(enhancing patient experience, improving population, reducing costs,
and improving the health care team experience. Therefore, we urge the
Subcommittee to provide $9.2 billion for HRSA programs for FY2022 to
improve the care of medically underserved Americans by strengthening
the health workforce.
The health professions' education programs, authorized under Title
VII of the Public Health Service Act and administered through HRSA,
support the training and education of health care providers to enhance
the supply, diversity, and distribution of the health care workforce.
Within the Title VII program, we urge the Subcommittee to fund the
Section 747 PCTE program at $71 million, in order to maintain and
expand the pipeline for individuals training in primary care. While the
College appreciates the $10 million increase to the program in FY2018,
ACP urges more funding because the Section 747 PCTE program is the only
source of federal training dollars available for general internal
medicine, general pediatrics, and family medicine. For example, general
internists, who have long been at the frontline of patient care, have
benefitted from PCTE grants for primary care training in rural and
underserved areas that have helped prepare physicians for a career in
primary care.
The College urges at least $860 million in total program funding
for the NHSC in FY2022. In FY2021, the NHSC received $120 million in
discretionary funding to expand and improve access to quality opioid
and substance use disorder treatment in underserved areas, in addition
to $310 million in mandatory funds which have been extended through
FY2023. The NHSC awards scholarships and loan repayment to health care
professionals to help expand the country's primary care workforce and
meet the health care needs of underserved communities across the
country. In FY2020, with a projected field strength of over 14,000
primary care clinicians, NHSC members are providing culturally
competent care to a target of almost 15 million patients at a targeted
18,000 NHSC-approved health care sites in urban, rural, and frontier
areas. These funds would help maintain NHSC's field strength helping to
address the health professionals' workforce shortage and growing
maldistribution. There is overwhelming interest and demand for NHSC
programs, and with more funding, the NHSC could fill more primary care
clinician needs. In FY2016, there were 2,275 applications for the
scholarship program, yet only 205 new awards were made. There were only
150 scholarship awards in FY2020. There were 7,203 applications for
loan repayment and only 3,079 new awards in FY2016. Accordingly, ACP
urges the subcommittee to double the NHSC's overall program funding to
$860 million to meet this need and to sustain the American Rescue Plan
Act's $800 million for the NHSC for when the pandemic subsides.
AHRQ is the leading public health service agency focused on health
care quality. AHRQ's research provides the evidence-based information
needed by consumers, clinicians, health plans, purchasers, and
policymakers to make informed health care decisions. The College is
dedicated to ensuring AHRQ's vital role in improving the quality of our
nation's health and recommends a budget of $500 million, restoring the
agency to its FY2010 enacted level adjusted for inflation. This amount
will allow AHRQ to help providers help patients by making evidence-
informed decisions, to fund research that serves as the evidence engine
for much of the private sector's work to keep patients safe, and to
make the healthcare more efficient by providing quality measures to
health professionals.
ACP supports at least $296.5 million in discretionary funding for
federal exchanges within CMS' Program Operations, which has been funded
at $2.8 billion in FY2020. This funding would allow the federal
government to continue administering the insurance marketplaces, as
authorized by the Affordable Care Act, if a state has declined to
establish an exchange that meets federal requirements. CMS now manages
and operates some or all marketplace activities in over 30 states.
Without these funds it will be much more difficult for the federal
government to operate and manage a federally-facilitated exchange in
those states, raising questions about where and how their residents
would obtain and maintain coverage, especially with increased need for
health coverage due to the COVID-19 pandemic.
The Center for Disease Control and Prevention's mission is to
collaborate to create the expertise, information, and tools needed to
protect their health-through health promotion, prevention of disease,
injury, and disability, and preparedness for new health threats. ACP
supports $10 billion overall for this mission, especially in light of
the ongoing COVID-19 public health emergency (PHE). The College also
supports $50 million for the CDC's Injury and Prevention Control to
fund research on firearm Injury and mortality prevention research and
support 10 to 20 multi-year studies to continue to continue to rebuild
lost research capacity in this area. ACP greatly appreciates funding
for this research in FY2020 and FY2021 after many years of no federal
resources for researching the prevention of firearms-related injuries
and deaths. The College also supports the administration's budget
request of $153 million for the NCCDPHP to fund its Social Determinants
of Health program. The PHE caused by the COVID-19 has highlighted the
urgent need to collect racial, ethnic, and language preference
demographic data on testing, infection, hospitalization, and mortality
during a pandemic. These data should be shared with local, state,
territorial, and tribal governments. Frequent, granular, and high-
quality disaggregated demographic data are needed to fully understand
the impact on racial and ethnic minority communities and better offer
targeted care not only for COVID-19, but for health care overall.
Lastly, the College strongly supports $46.1 billion for NIH in
FY2022 so the nation's medical research agency continues making
important discoveries that treat and cure disease to improve health and
save lives and that maintain the United States' standing as the world
leader in medical and biomedical research.
The College greatly appreciates the support of the Subcommittee on
these issues and looks forward to working with Congress on the FY2022
appropriations process.
[This statement was submitted by Jared Frost, Senior Associate,
Legislative
Affairs, American College of Physicians.]
______
Prepared Statement of the American College of Surgeons
Chairwoman Murray, Ranking Member Blunt, and Members of the
Subcommittee, on behalf of the more than 82,000 members of the American
College of Surgeons (ACS), thank you for the opportunity to submit
written testimony addressing fiscal year (FY) 2022 appropriations. The
ACS is a scientific and educational organization of surgeons that was
founded in 1913 to raise the standards of surgical practice and improve
the quality of care for all surgical patients. ACS is dedicated to the
ethical and competent practice of surgery. Its achievements have
significantly influenced the course of scientific surgery in America
and have established it as an important advocate for all surgical
patients.
The ACS respectfully requests your consideration of the following
priorities as the Subcommittee works through the annual appropriations
process for FY 2022:
Military and Civilian Partnership for the Trauma Readiness Grant
Program (MISSION ZERO)
In 2016, the National Academies of Science, Engineering, and
Medicine (NASEM) released a report titled, ``A National Trauma Care
System: Integrating Military and Civilian Trauma Systems to Achieve
Zero Preventable Deaths After Injury.'' This report suggests that one
in four military trauma deaths and one in five civilian trauma deaths
could be prevented if advances in trauma care reach all injured
patients. The report concludes that military and civilian integration
is critical to saving lives both on the battlefield and at home,
maintaining the nation's readiness and homeland security.
The MISSION ZERO Act was signed into law on June 24th, 2019 as part
of S. 1279, the Pandemic and All Hazards Preparedness and Advancing
Innovation (PAHPAI) Act (Public Law No:116-22). MISSION ZERO takes the
recommendations of the NASEM report to create a grant program, within
the U.S. Department of Health and Human Services (HHS), to cover the
administrative costs of embedding military trauma professionals in
civilian trauma centers. These military-civilian trauma care
partnerships will allow military trauma care teams and providers to
gain exposure to treating critically injured patients and increase
readiness for when these units are deployed, further advancing trauma
care and providing greater patient access.
By facilitating the implementation of military-civilian trauma
partnerships, this program will preserve lessons learned from the
battlefield, translate those lessons to civilian care, and ensure that
service members maintain their readiness to deploy in the future. The
ACS strongly supports the funding of MISSION ZERO at the authorized
amount of $11.5 million for FY 2022.
Funding for Cancer Research and Prevention
The ACS Cancer Programs, including the Commission on Cancer (CoC),
is dedicated to improving survival and quality of life for cancer
patients through advocacy on issues pertaining to prevention and
research. To continue the progress that has led to medical
breakthroughs for treatment therapies for millions of cancer patients,
the ACS supports the following funding increases for FY 2022.
To ensure a robust, long-term commitment to cancer research and
prevention, Congress should increase the overall budget of the National
Institutes of Health (NIH) to at least $46.111 billion including $7.609
billion for the National Cancer Institute (NCI). The ACS also urges the
inclusion of $559 million for cancer programs at the Centers for
Disease Control and Prevention (CDC), including $50 million for the
National Comprehensive Cancer Control Program, and $70 million for the
National Program of Cancer Registries (NPCR).
Firearm Morbidity and Mortality Prevention Research
According to the Centers for Disease Control and Prevention (CDC),
there were more than 39,000 firearm-related fatalities in 2019, a
measured increase over previous years. ACS believes this number can be
reduced through federally funded firearms research. As with other
injury prevention related efforts, public health research can play a
role in reducing the number of firearm-related injuries and deaths.
Federally funded research from the perspective of public health has
contributed to reductions in motor vehicle crashes, smoking, and Sudden
Infant Death Syndrome (SIDS). ACS believes that a similar approach can
provide necessary data to inform efforts to reduce firearm-related
injuries and deaths. The ACS supports $50 million specifically for
public health research into firearm morbidity and mortality prevention
through the CDC for FY 2022.
Removal of Language in Section 510
Serious patient safety concerns arise if a patient's health record
is mismatched or includes inaccurate or incomplete information,
potentially resulting in missed allergies, medication interactions, or
duplicate tests ordered. Unfortunately, there is no accurate or
consistent way for surgeons to link patients to their health
information across the continuum of care, due to long-standing federal
statutory language. The language, located in Section 510 of the LHHS
Appropriations bill, has prohibited HHS from spending any federal
dollars to promulgate or adopt a Unique Patient Identifier, thereby
hampering public-private sector collaborative efforts to advance a
nationwide patient identification strategy that is cost-effective,
scalable, secure, and prioritizes patient privacy.
Removing the language in Section 510 will provide HHS with the
ability to evaluate a range of patient identification solutions and
enable the agency to work with the private sector to explore potential
challenges. ACS supports removal of Section 510 from the Labor-HHS
appropriations bill that prohibits HHS from spending any federal
dollars to promulgate or adopt patient identification strategies.
Thank you for your consideration of our requests. Please contact
Amelia Suermann, ACS Congressional Lobbyist, at [email protected] if
you have any questions or would like additional information.
______
Prepared Statement of the American Educational Research Association
Chair Murray, Ranking Member Blunt, and Members of the
Subcommittee, thank you for the opportunity to submit written testimony
on behalf of the American Educational Research Association (AERA). AERA
recommends that the Institute of Education Sciences (IES) within the
Department of Education receive $737.47 million for FY 2022, aligned
with the top line included in the president's budget request. This
recommendation is also consistent with the request from the Friends of
IES coalition, for which we are a leading member. In addition, AERA
recommends the base funding level of $46.1 billion for the National
Institutes of Health (NIH) in fiscal year 2022, in support of important
research in the Eunice Kennedy Shriver National Institute of Child
Health and Human Development (NICHD) and the Office of Behavioral and
Social Science Research (OBSSR).
AERA is the major national scientific association of 25,000
faculty, researchers, graduate students, and other distinguished
professionals dedicated to advancing knowledge about education,
encouraging scholarly inquiry related to education, and promoting the
use of research to improve education and serve the public good. Our
members, as well as state and federal policymakers and practitioners,
rely on IES to provide and support reliable education statistics, data,
research, and evaluations.
IES is the independent and nonpartisan statistics, research, and
evaluation arm of the U.S. Department of Education charged with
supporting and disseminating rigorous scientific evidence on which to
ground education policy and practice. Located within the Department of
Education to provide essential education data, statistics, and science
to the Department, the federal government, and the nation, the mission
of IES is analogous to other prominent federal research agencies such
as the National Science Foundation and the National Institutes of
Health.
We appreciate the increase to IES appropriations over the past few
fiscal years and the funding provided in the American Rescue Plan Act,
the latter of which will go toward needed resources in data and special
education research to understand how schools will work to address
learning gaps due to lost instructional time. Throughout the pandemic,
IES has served as an important resource in providing information about
distance learning; pursuing interventions to address socioemotional
needs; and collecting salient data on schools offering remote, hybrid,
and in-person learning. The increased demand for evidence-based
programs since the onset of COVID-19 and the need to address potential
learning recovery only further speaks to the priority importance of
support for education research and statistics at IES to inform policy
and practice.
We see numerous examples of bipartisan support for scientific
research and evidence-based decision making. The Department of
Education is implementing the provisions of the bipartisan Foundations
of Evidence-Based Policymaking Act, which directs federal agencies to
leverage data and evaluations to inform policy decisions. A bipartisan
bill that has been introduced to inform the forthcoming reauthorization
of the Workforce Investment and Opportunity Act (WIOA) would call for
investment in research in adult education. The data and research
infrastructure to build evidence for improving educational outcomes
require additional funding necessitating action by your committee.
Since IES was created in 2002, it has made visible scientifically-
based contributions to the progress of education that are used in
classrooms across the country. For example, IES has funded research on
multi-tiered systems of support, including positive behavior
interventions and supports, that have been highlighted in the
Department of Education's COVID-19 handbook to guide school reopening.
Several webinars and resources produced by the Regional Educational
Laboratories highlighting evidence-based practices for educators,
school support staff, and school leaders are incorporated in the Safer
Schools and Campuses Best Practices Clearinghouse. As the nation
continues to emerge from the pandemic, this is a critical time to
invest in education research to produce essential knowledge about
teaching and learning across all levels of education as well as to
identify lessons learned that can foster educational innovations.
States are increasingly seeking ways to determine the long-term
impact of state policies, including in education, and they turn to
information in their Statewide Longitudinal Data Systems (SLDS).
Initially developed to help states measure accountability, data has
transformed from a hammer to a flashlight, increasing understanding
about student performance and teacher effectiveness. To date, IES has
been unable to meet the state demand for SLDS grants. For the FY 2019
competition, 28 of 44 states that submitted applications received
grants, although the average amount of grants was reduced by half
compared with those awarded in FY 2015. Growing interest in using data
from these systems, including an IES research competition encouraging
the research use of these data for examining longitudinal impacts of
state policies, show the importance of continuing investment in these
data systems.
AERA also is concerned with the reduced staff capacity at IES, and
I would like to draw particular attention to the decades-long staff
attrition at the National Center for Education Statistics (NCES). As
the second-oldest principal federal statistical agency in the United
States, NCES provides objective, nonbiased data on a wide range of
education indicators, including information on teacher salaries, the
amount of loans taken out by undergraduate students, and the
participation of students in English language learner programs. NCES
staff are also responsible for the development and administration of
the National Assessment of Educational Progress, detailing longitudinal
trends in student achievement. In recognizing the need for NCES to
produce accurate, reliable, and trustworthy data, we encourage the
subcommittee to ensure that NCES and IES have the appropriate level of
staff in order to effectively carry out their missions in the Program
Management line.
In addition to IES, AERA recommends $46.1 billion for the National
Institutes of Health (NIH) in fiscal year 2022 with proportional
increases for the Eunice Kennedy Shriver National Institute of Child
Health and Human Development (NICHD) and the Office of Behavioral and
Social Science Research (OBSSR). NICHD supports research at the
intersection of health and education, including ways to foster health
literacy, potential influencers of family environments on child well-
being and cognitive development, and interventions for students with
learning disabilities who struggle with reading. Investment in NICHD
will allow the institute to continue research to both increase
understanding how best to support executive functioning, and to bolster
the professional development of early career researchers. OBSSR plays
an important role in coordinating and co-funding behavioral and social
science research across NIH that contribute to the understanding of
influences on health and interventions to improve health outcomes.
OBSSR has long recognized the interdependence of education and health
and in terms of prevention, intervention, and the health-risk
consequences of a lack of or limited educational exposure.
Thank you for the opportunity to submit written testimony in
support of $737 million for IES and $46.1 billion in base level funding
for NIH in fiscal year 2022. AERA welcomes working with you and your
subcommittee on strengthening investments in essential research, data,
and statistics related to education and learning.
[This statement was submitted by Felice J. Levine, PhD, Executive
Director, American Educational Research Association.]
______
Prepared Statement of the American Foundation for Suicide Prevention
The American Foundation for Suicide Prevention (AFSP), the nation's
largest non-profit dedicated to saving lives and bringing hope to those
effected by suicide is submitting testimony on behalf of our over 30
thousand volunteer Field Advocates nationwide. AFSP has Chapters in all
50 states and sponsors a variety of community-based programming across
the country each year.
The following testimony outlines suicide in the United States and
AFSP's recommendations to the Subcommittee for Fiscal Year 2022.
suicide: a national public health crisis
Suicide is the second leading cause of death for ages 10-34 in the
United States and in 2019 was the 10th leading cause of death.\1\
Provisional 2020 suicide death data from the CDC show that deaths by
suicide in the U.S. declined from 47,511 to 44,834 (5.6%) between 2019
and 2020.\2\ Suicide reportedly moved from the tenth to the eleventh
leading cause of death as COVID-19 became the third leading cause of
death in 2020.\3\ While the decreases in suicide deaths are promising
and the curve may be beginning to shift downward, efforts must continue
to be expanded and built upon to ensure there are mental health
resources as the pandemic continues to shift and impact different
populations disproportionately. Historically, suicide rates have
initially gone down during some periods of wartime and other disasters
and have shown mixed results during or after previous epidemics.
Provisional 2020 data appear consistent with this trend. It is
possible, though not pre-determined, that we could experience an
increase in suicide risk as the immediate COVID-19 threat lessens and
in the aftermath period if community cohesion diminishes and if less
attention is paid to intentional social connections, proactive
resilience and mental health self-care, and the importance at key times
of engaging in mental health treatment and crisis care. Helping those
who are struggling with basic needs can also mitigate suicide risk.
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\1\ https://www.cdc.gov/injury/wisqars/index.html.
\2\ https://jamanetwork.com/journals/jama/fullarticle/
2778234?utm_source=newsletter&utm_
medium=email&utm_campaign=newsletter_axiosvitals&stream=top.
\3\ Ibid.
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While provisional 2020 mortality data show a declining rate of
suicide for the overall U.S. population, we do not yet have the full
picture as to how this translates to geographic areas within states or
specific populations. The pandemic has had a disproportionate impact on
certain populations; there are concerning signals of increasing suicide
rates in some non-White populations during the pandemic, e.g., in
Maryland and Connecticut.\4\ It may be a year or longer until data and
research are available to understand the entire impact of COVID-19 on
suicide.
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\4\ https://jamanetwork.com/journals/jamapsychiatry/fullarticle/
2774107.
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Furthermore, during the COVID-19 pandemic, data show 50-70% of the
population report elevations in experiences of depression, anxiety,
loneliness, trauma, loss, grief and increased substance use.\5\
Numerous studies have kept abreast of the nation's mental health
experiences and suffering during the pandemic through various
mechanisms such as the CDC Household Pulse Survey during COVID which
has been surveying 60-90,000 Americans adults every 3-5 weeks during
the pandemic. The portion of the American public experiencing anxiety,
isolation, symptoms of depression, insomnia and increased substance use
has been rising.
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\5\ https://www.cdc.gov/nchs/covid19/pulse/mental-health-care.htm.
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As the pandemic progressed during 2020, the proportion of
respondents who reported detrimental effects on their mental health
continued to rise--39% in May 2020 and 53% in July 2020. It was only
until just recently, in March 2021, that we are seeing the first
decreases in distress--8-10 percentage points--for depression and
anxiety across age and demographic groups.\6\ However, the CDC reported
on June 18, 2021 there was a 51 percent rise in suspected suicide
attempts among girls ages 12-17 from February 2021 to March 2021
compared to the same time period in 2019, prior to the pandemic.\7\
While this does not mean that there was necessarily an uptick in
suicide deaths, the statistic is certainly alarming, and we do not yet
have race and ethnicity data for when this study was conducted.
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\6\ https://www.cdc.gov/mmwr/volumes/69/wr/mm6932a1.htm.
\7\ https://www.cdc.gov/mmwr/volumes/70/wr/
mm7024e1.htm?s_cid=mm7024e1_w.
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recommendations
As instances of suicidal ideation and attempts increase, funding
and resources must meet the needs of those most at risk. Therefore,
AFSP is advocating for Fiscal Year 2022 funding increases to ensure
that communities are adequately prepared to respond to crisis,
implement community-based programming for those most at risk, collect
data to improve prevention, and to invest in research to meet patients
where they are, in healthcare settings. We thank Chairwoman Murray and
Ranking Member Blunt for the opportunity to share our below priorities.
Substance Abuse and Mental Health Services Administration (SAMHSA)
The National Suicide Prevention Lifeline coordinates a network of
over 180 crisis centers across the United States by providing 24/7 free
and confidential suicide prevention and crisis intervention services
for people in distress, their loved ones, and best practices for
professionals. The Lifeline routes calls from anywhere in the country
to a network of certified local crisis centers that can then link
callers to local emergency, mental health, and social services
resources. Last year, over 2.5 million calls were made to the Lifeline,
resulting in longer wait times and a strain on local crisis centers.
Additional funding is needed to ensure that the Lifeline is adequately
equipped to handle increasing call and outreach volume.
We request at least $102 million for the National Suicide
Prevention Lifeline, as included in the President's Fiscal Year 2022
Budget Request. Following passage of the National Suicide Hotline
Designation Act in September 2020, the easily accessible 9-8-8 dialing
code was designated to replace the Lifeline's current 1-800 number. 9-
8-8 will be the new easy to remember and universal phone number for
suicide prevention and mental health crisis by July 2022. This presents
an urgent need to ensure that local crisis call centers and the
national infrastructure for the Lifeline are prepared for the
anticipated increase in calls and strain on an already overburdened
system. Additional funding to the Lifeline would facilitate the
development of a unified call center platform and data analytics,
telecom costs for each contact and routing to local crisis centers,
provision of specialized services at national back up centers for
calls, chat, and text, targeted funding for call centers and national
backup centers, multi-lingual assistance, quality assurance and
training standards, and supporting partnership outreach. Based on an
initial analysis from Vibrant Emotional Health, the current
administrator of the Lifeline, year one implementation estimates for
988 could grow to as much as $240 million. It is expected that SAMHSA
and the Department of Veterans Affairs (VA) will jointly release a
final cost estimate report to Congress regarding Lifeline funding needs
later in the summer of 2021 which will help better inform the critical
resource needs that are urgently needed. We hope the Appropriations
Committee will work with us to adequately address this critical
resource, in Fiscal Year 2022 and beyond.
The Centers for Disease Control (CDC)
As the nation's leading health protection agency, it is a natural
fit that the CDC expand their suicide prevention efforts. Through
investing further in the CDC's new suicide prevention line, there is a
more holistic approach to suicide prevention programming beyond the
work that SAMHSA and the National Institutes of Health (NIH) are
implementing, evaluating, and researching. There is a need to make
strategic investments that will help save lives and reduce the suicide
rate. Therefore, AFSP advocates for $36 million for Suicide Prevention
initiatives at CDC's Center for Injury Prevention and Control. Created
in Fiscal Year 2020, the Congress has generously provided $22 million
for the program over the last two fiscal years. Enhanced funding in
Fiscal Year 2022 will help expand these community-based grants into
approximately 25 states. The grants are used to implement and evaluate
a comprehensive public health approach to suicide prevention, with
attention to vulnerable populations, such as Veterans, tribal and rural
communities, LGBTQ, or homeless citizens. These groups account for a
significant proportion of the suicide burden and have suicide rates
greater than the general population. A key outcome of this funding is a
10% reduction in suicide and suicide attempts among vulnerable
populations. Through these cooperative agreements, CDC aims to build a
national program that will help reverse increasing suicide trends
across our nation and contribute to the national goal of reducing
suicide by 20% by 2025.
Data collection as it relates to suicide deaths is an important
piece of preventing future deaths and implementing prevention
strategies within our communities. AFSP advocates for a $10 million
increase for the National Violent Death Reporting System (NVDRS) as
included in the President's Fiscal Year 2022 Budget Request. NVDRS is
the most comprehensive database on circumstances surrounding violent
deaths in the U.S., including suicide. Since the program's inception in
2002, NVDRS has grown to a nationwide program with funding to support
implementation in all 50 states and select territories. Yet, the
current funding is not sufficient for long-term program success. States
are clamoring for additional resources to address various
implementation challenges and support investments in program
infrastructure, as well as program growth and innovation. NVDRS
stakeholder organizations support a funding level of $50 million by FY
2027 to strengthen the program.
National Institute of Mental Health
As the largest private funder of suicide prevention research in the
US, AFSP continues to advocate for increased federal funding and
prioritization of suicide prevention research. The National Institutes
for Health and more specifically the National Institute of Mental
Health (NIMH) play a key role in advancing the Nation's suicide
prevention research priorities. AFSP encourages the continued
implementation of the Prioritized Research Agenda for Suicide
Prevention released by the National Action Alliance for Suicide
Prevention, that is meant to advance the National Strategy for Suicide
Prevention. To note, more recently, in January 2021, there was a
Surgeon Generals Call to Action to Implement the National Strategy for
Suicide Prevention, which further outlines the six actions and
associated strategies that will move the U.S. further towards
implementation of the National Strategy. Overall imparting the need for
increased federal investment in suicide prevention research and
programmatic needs.
As the COVID-19 pandemic shifts, there is a need to ensure that
when individuals are visiting the Emergency Department or their primary
care physician that screening tools and resources meet them, so if they
are in need of mental health and crisis services, they are able to
receive comprehensive care. This is an especially prominent area for
necessary research as, up to 45 percent of people who die by suicide
visit their primary care physician in the month prior to their
death.\8\ AFSP recommends the following report language for Fiscal Year
2022, to place a special emphasis on the primary care setting, given
the great number of Americans seeking mental health care from their
primary care physician.
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\8\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3146379/
#::text=A%20review%20of%20
studies%20analyzing,the%20month%20before%20their%20death.&text=Only%2020
%25%20 saw%20a%20mental,10%20in%20the%20preceding%20month.
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proposed fiscal year 2022 report language: suicide prevention
The Committee is encouraged that 2019 was the first year in two
decades in which the suicide rate decreased. But death by suicide
remains the tenth leading cause of death in the United States, and the
Committee remains committed to providing the resources necessary to
address this alarming crisis. The Committee commends NIMH for
consistently expanding resources for suicide screening and prevention
research over the last four fiscal years and strongly encourages the
Institute to provide additional increases for this purpose in fiscal
year 2022, with special emphasis on producing models that are
interpretable, scalable, and practical for clinical implementation,
including utilization of healthcare, education and criminal justice
systems that serve populations at risk. In addition, the Committee
encourages NIMH to prioritize research efforts related to primary care
settings to evaluate suicide prevention interventions, strategies, and
programs, including assessments of the effects of the COVID-19
epidemic. The Committee requests that NIMH provide an update on these
efforts in the fiscal year 2023 Congressional Justification.
The American Foundation for Suicide Prevention is grateful for the
Subcommittee's continued support of suicide prevention efforts and
looks forward to additional conversations about the vital resources
needed to help save lives and prevent suicide. Please do not hesitate
to contact Natalie Tietjen, Manager of Federal Policy
([email protected]) on my staff with additional questions or
clarifications.
[This statement was submitted by Laurel Stine, JD, MA, Senior Vice
President, Public Policy, American Foundation for Suicide Prevention.]
______
Prepared Statement of the American Gastroenterological Association
national cancer institute
Chairwoman Murray, Ranking Member Blunt, and members of the
Subcommittee, I would like to start by thanking you for the opportunity
to submit testimony on the U.S. Department of Health and Human Services
(HHS) fiscal year (FY) 2022 appropriations bill. I am Dr. Fola May, and
I am an associate professor of medicine at the University of
California, Los Angeles, and researcher at the UCLA Center for Cancer
Prevention Control Research (CPCR) and UCLA Kaiser Permanente Center
for Health Equity. I am submitting testimony on behalf of the American
Gastroenterological Association (AGA). The AGA was founded in 1897, and
today, it has expanded its membership to include more than 16,000
professionals who are dedicated to the advancement of science,
practice, and research in the field of gastroenterology. We want to
first thank you for your ongoing bipartisan investment in the National
Institutes of Health (NIH). We respectfully request the subcommittee to
support our FY 2022 NIH funding recommendation of at least $46.111
billion, a $3.177 billion increase over the comparable FY 2021 funding
level for the NIH, which would allow for the NIH's base budget to keep
pace with the biomedical research and development price index of 2.3 %
and allow meaningful growth of 5%. Additionally, we request report
language to support research to better understand the impact of COVID-
19 on colorectal cancer disparities.
Colorectal Cancer Incidence
Colorectal cancer (CRC) remains the second leading cause of cancer
deaths in the United States. The American Cancer Society (ACS) \1\
estimates 149,500 new cases of CRC and 52,980 CRC-related deaths in the
U.S. in 2021. The ACS 2021 cancer report also shows an emerging trend
of CRC in a younger demographic; The data shows a 2% increase in CRC in
individuals under 50 years.
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\1\ American Cancer Society. Cancer Facts & Figures 2021. Atlanta:
American Cancer Society; 2021. https://www.cancer.org/content/dam/
cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-
and-figures/2021/cancer-facts-and-figures-2021.pdf.
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CRC has a higher impact on communities of color. Specifically,
Black, and Native American individuals have the highest incidence of
CRC; Black Americans have the highest rate of CRC-related death, and
Latinos have CRC screening rates far below White and Black
Americans.\2\
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\2\ Balzora, S., Issaka, R. B., Anyane-Yeboa, A., Gray, D. M., 2nd,
& May, F. P. (2020). Impact of COVID-19 on colorectal cancer
disparities and the way forward. Gastrointestinal endoscopy, 92(4),
946-950. https://doi.org/10.1016/j.gie.2020.06.042.
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COVID-19's Impact on CRC Screenings
Screening can prevent colorectal cancer deaths by detecting
precancerous polyps early, allowing for early treatment and full
recovery. Unfortunately, as with other health care services, the COVID-
19 pandemic significantly reduced the volume of preventive screenings.
According to a report,\3\ CRC screenings were estimated to have dropped
by 86% in the first few months of the pandemic and have not yet fully
recovered.
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\3\ EPIC Health Research Network. Delayed Cancer Screenings-A
Second Look. Available at: https://ehrn.org/articles/delayed-cancer-
screenings-a-second-look/. pdf. Accessed May 17, 2021.
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With the drop in screenings, delay in diagnosis, lack of access to
care, abandonment of care, interruption or alteration in treatment and
job loss resulting in lapsed health insurance coverage etc., cancer
mortality rates across numerous cancers have increased. The National
Cancer Institute (NCI) estimates a 1% increase in deaths from breast
and colon cancer over the next 10 years, which equates to an additional
10,000 deaths due to the pandemic's impact on screening and
treatment.\4\
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\4\ Sharpless, N. E. (2020). COVID-19 and cancer. https://tcjl.com/
wp-content/uploads/2020/06/Science-COVID-19-and-Cancer-editorial-
copy.pdf.
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As communities across the U.S. fight the pandemic locally,
community-based health care facilities that typically would offer
cancer screenings and other preventative health services have
reallocated their limited resources and shifted workforce deployment to
address the pandemic. This reduction in cancer screening resources has
heightened the ongoing health care access issues that impact vulnerable
populations, and their worsening clinical outcomes. Specifically,
racial, and ethnic minority communities, who, including before the
pandemic, have lower rates of CRC screening and higher rates of
incidence and mortality from CRC.
Health disparities and CRC
Colorectal cancer (CRC) during the pandemic places a spotlight on
the health disparities and inequities stemming from social determinants
of health that continue to plague medically underserved populations.
COVID-19 cases, hospitalizations and deaths were highest among
communities of color, especially those with comorbidities like obesity,
diabetes, and asthma. Although screening rates are resuming, the rates
in minority communities likely still lag due to access, financial,
transportation and other socioeconomic factors exacerbated by the
pandemic.
The NIH resources spent on COVID-19 and health disparities have
been essential to better understand the long-term impact of the
pandemic on the medically underserved population in the U.S. To improve
CRC screening, prevention and treatment, AGA recognizes the continued
need to collect systemic data on the short and long-term outcomes of
COVID-19 and CRC disparities. Therefore, AGA urges the subcommittee to
include the following report language that would allow NIH to continue
its support of studies focused on CRC disparities heightened by the
COVID-19 pandemic.
COVID-19 Pandemic Impact on Colorectal Cancer Disparities.--Given
the impact that screening can have on reducing mortality and morbidity
in colorectal cancer (CRC), the Committee encourages the NIH to study
the impact of the COVID-19 pandemic on the incidence of CRC in minority
communities. The committee is hopeful that such information will
provide policymakers with a better understanding of the effects on
minority communities and help develop strategies to address barriers to
screening and reduce health inequities and cancer deaths.
On behalf of AGA, its members, and the GI community, I would like
to thank you for your consideration of this request. If you have any
questions, please contact Kathleen Teixeira, Vice President of
Government Affairs, at [email protected].
[This statement was submitted by Dr. Fola May, MD, PhD, MPhil,
Associate
Professor of Medicine, University of California, Los Angeles.]
______
Prepared Statement of the American Geophysical Union
The American Geophysical Union (AGU), a non-profit, non-partisan
scientific society, appreciates the opportunity to submit testimony
regarding the fiscal year (FY) 2022 appropriation for the National
Institute of Environmental Health Sciences (NIEHS). AGU, on behalf of
its community of 130,000 Earth and space scientists, respectfully
requests that the 117th Congress appropriate $875 million for the
NIEHS. AGU's appropriations request takes into consideration any
previous budget cuts is driven by the need for significant investment
in federal research and development to ensure that the U.S. remains at
the forefront of research and innovation.\1\
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\1\ This amount of growth is recommended by the Innovation: An
American Imperative statement, which was authored by nine large U.S.
corporations and endorsed by over 500 leading industry, higher
education, science, and engineering organizations from across the 50
states. https://innovation-imperative.herokuapp.com/index.html.
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Under the umbrella of the National Institutes of Health (NIH), the
NIEHS conducts essential, innovative research that advances our
understanding of the effects of environmental changes or exposures on
human health and disease in the U.S. and across the globe. Through
NIEHS research, policymakers have access to vital, unbiased science
that is necessary for making informed decisions when addressing public
health issues. A few examples of the NIEHS's invaluable work are
provided below.
Improving Disaster Response, Reducing Health Impacts, & Preventing
Future Harm
The NIH Disaster Research Response program, launched by the NIEHS
and the National Library of Medicine, helps to address the ongoing need
for time-sensitive research in the aftermath of disasters, such as
hurricanes, wildfires, oil spills, and public health crises. Such
research helps scientists, government agencies, and communities better
understand immediate environmental exposures and injury risks,
potential short-term and long-term health impacts, the effectiveness of
health response efforts and environmental cleanup efforts, as well as
factors affecting post-disaster recovery and resiliency to future
events. To support timely gathering of the environmental and toxicology
data needed, the program has readily available research protocols, data
collections tools, and training resources.\2\
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\2\ See, NIH Disaster Research Response Program (DR2), https://
dr2.nlm.nih.gov/.
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Increasing Knowledge of Health Effects Related to PFAS Exposure
The NIEHS continues to be at the forefront of research on
perfluoroalkyl and polyfluoroalkyl substances (PFAS). A couple of years
ago, at least 610 locations in 43 states were known to be affected by
PFAS contamination, which included drinking water systems serving an
estimated 19 million people.\3\ Research into the possible health
impacts of PFAS chemicals exposure has already unmasked many links to
adverse health outcomes. For example, research has revealed that PFAS
exposure may increase a woman's risk of pregnancy complications.\4\
However, there is still much to understand regarding the effects of
PFAS exposure, which is why the NIEHS continues to conduct research and
award grants to external organizations across the nation.
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\3\ Based on data analysis by the Environmental Working Group and
Northeastern University. Walker, B., (6 May 2019). Mapping the PFAS
contamination crisis: New data show 610 sites in 43 states, EWG News
and Analysis, https://www.ewg.org/news-and-analysis/2019/04/mapping-
pfas-contamination-crisis-new-data-show-610-sites-43-states.
\4\ Broadfoot, M., (February 2020). Replacement chemicals may put
pregnancies at risk. Environmental Factor, NIEHS Newsletter, https://
factor.niehs.nih.gov/2020/2/science-highlights/replacement/index.htm.
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Growing the Environmental Health Science Workforce
To further expand the world's understanding of environmental
impacts on human health and disease and support interdisciplinary
scientific research, the NIEHS provides training and educational
opportunities for students of all ages-from the high school and
undergraduate levels to graduate students and faculty. For example, the
NIEHS Medical Student Research Fellowship program provides medical
students an opportunity to train in environmental health-related
research for a year at the NIEHS.\5\ The NIEHS also awards NIH Summer
Research Experience Program (R25) grants that give high school and
college students and science teachers an opportunity to gain valuable
research experience at a higher education institution during the
summer.\6\
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\5\ See, NIEHS Medical Student Research Fellowships, https://
www.niehs.nih.gov/careers/research/med-students/index.cfm.
\6\ See, the NIH Summer Research Experience Programs (R25), https:/
/www.niehs.nih.gov/research/supported/irt/summer_research/index.cfm.
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conclusion
At a time when our nation is recovering and has many pressing
priorities that need to be addressed, the future of the U.S. will be
strengthened by strong and sustained investments in the full scope of
our research enterprise-including new, innovative research regarding
the impact of environmental factors on human health generated by the
NIEHS. AGU appreciates the Subcommittee's leadership in this area, as
well as the opportunity to submit this testimony. Thank you for your
thoughtful consideration of our request.
[This statement was submitted by Michael Villafranca, Senior
Specialist, Science Policy & Government Relations.]
______
Prepared Statement of the American Geriatrics Society
The American Geriatrics Society (AGS) greatly appreciates the
opportunity to submit this testimony. The AGS is a national non-profit
organization of nearly 6,000 geriatrics healthcare professionals and
basic and clinical researchers dedicated to improving the health,
independence, and quality of life of all older Americans. As the
Subcommittee works on its fiscal year (FY) 2021 Labor, Health and Human
Services, and Related Agencies Appropriations Bill, we ask that you
prioritize funding for the geriatrics education and training programs
under Title VII of the Public Health Service (PHS) Act, and for aging
research within the National Institutes of Health (NIH) and National
Institute on Aging (NIA).
We are appreciative of your ongoing support of the Title VII
Geriatrics Health Professions Programs at the Health Resources and
Services Agency (HRSA), which includes the Geriatrics Workforce
Enhancement Program (GWEP) and Geriatrics Academic Career Award (GACA)
program. However, the AGS believes it is urgent that we increase the
educational and training opportunities in geriatrics and gerontology
and ensure that HRSA receives the funding expansion necessary for these
critically important programs for the care and health of older adults.
We ask that the Subcommittee consider the following funding levels
for these programs in FY 2022:
--At least $105.7 million to support the GWEP and GACA program (PHS
Act Title VII, Sections 750 and 753(a))
--An increase of no less than $3.3 billion over the enacted FY 2021
level in the FY 2022 budget for total spending at NIH for
current institutes and operations; a minimum increase of $500
million to invest in biomedical, behavioral, and social
sciences aging research efforts across NIH; and a minimum
increase of $289 million for research on Alzheimer's disease
and related dementias over the enacted FY 2021 level in the FY
2022 budget
Sustained and enhanced federal investment in these initiatives is
essential to delivering high-quality, better coordinated, efficient,
and cost-effective care to our older Americans whose numbers are
projected to increase dramatically in the coming years. According to
the U.S. Census Bureau, the number of people age 65 and older is
projected to more than double from 54.1 million today \1\ to more than
94 million by 2060,\2\ while those 85 and older is projected to more
than triple from 6.4 million today to 19 million by 2060.\3\ As our
aging population increases, so too will the prevalence of diseases
disproportionately affecting older people--most notably Alzheimer's
disease and related dementias (including vascular, Lewy body, and
frontotemporal dementia)--and the economic burden associated with these
diseases.
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\1\ U.S. Census Bureau. 2019 American Community Survey 1-Year
Estimates Subject Tables. Available at https://data.census.gov/cedsci/
table?q=S0101&tid=ACSST1Y2019.S0101&hide
Preview=false.
\2\ U.S. Census Bureau. An Aging Nation: Projected Number of
Children and Older Adults. Available at https://www.census.gov/library/
visualizations/2018/comm/historic-first.html. Published March 13, 2018.
\3\ Ibid.
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To ensure that our nation is prepared to meet the unique healthcare
needs of this rapidly growing population, we request that Congress
provide additional investments necessary to expand and enhance the
geriatrics workforce, which is an integral component of the primary
care workforce, and to foster groundbreaking medical research.
programs to train geriatrics healthcare professionals
Geriatrics Workforce Enhancement Program and Geriatrics Academic Career
Award Program (at least $105.7 million)
Our healthcare workforce receives little, if any, training in
geriatric principles,\4\ which leaves us ill-prepared to care for older
Americans as health needs evolve, especially during the current COVID-
19 public health emergency. With our nation continuing to face a severe
shortage of geriatrics healthcare providers and academics with the
expertise to train these providers, the AGS believes it is urgent that
we increase the number of educational and training opportunities in
geriatrics and gerontology. The requested increase in funding over FY
2021 levels would help ensure that HRSA receives the funding necessary
to expand these critically important programs commensurate with the
increasing need.
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\4\ Only 3 percent of medical students take even one class in
geriatric medicine and fewer than 1 percent of RNs, pharmacists,
physician assistances and physical therapists are certified in
geriatrics or gerontology. Yet estimates are that by 2030, 3.5 million
additional health care professionals and direct-care workers will be
needed to care for older adults. 2018 Issue Brief, Eldercare Workforce
Alliance, Available at https://eldercareworkforce.org/wp-content/
uploads/2018/03/GWEP_OnePager_v2.pdf.
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The GWEP is currently the only federal program designed to increase
the number of providers, in a variety of disciplines, with the skills
and training to care for older adults. The GWEP awardees educate and
engage the broader frontline workforce, including family caregivers,
and focus on opportunities to improve the quality of care delivered to
older adults, particularly in underserved and rural areas. Due to
GWEPs' partnerships with primary care and community-based
organizations, GWEPs are uniquely positioned to rapidly address the
needs of older adults and their caregivers. The GWEP was launched in
2015 by HRSA with 44 three-year grants provided to awardees in 29
states. In 2019, HRSA funded a second cohort of 48 GWEPs across 35
states and two territories (Guam and Puerto Rico) and provided
extension grants to 15 former GWEP awardees.
The GACA program is an essential complement to the GWEP. GACAs
ensure we can equip early-career clinician educators to become leaders
in geriatrics education and research. It is the only federal program
designed to increase the number of faculty with geriatrics expertise in
a variety of disciplines. The program was eliminated in 2015 through a
consolidation of several training programs. However, the program was
reestablished in November 2018 when HRSA released a funding opportunity
indicating their intention to fund 26 GACAs for four years starting
September 1, 2019. Since 1998, original GACA recipients have trained as
many as 65,000 colleagues in geriatrics expertise and have contributed
to geriatrics education, research, and leadership across the U.S.
Most recently, the GWEPs and GACAs have been an asset for states as
many states and localities grapple with the rollout of the COVID-19
vaccine and address vaccine hesitancy. GWEPs have been staffing call
lines to assist older adults to register for the vaccine, advising
local authorities on making the sign-up websites age-friendly, and
working with health systems to participate in the rollout and outreach
to vulnerable and hard-to-reach populations, preventing widening the
health disparity gap exacerbated by the pandemic. Looking forward,
these programs will be critical in providing assistance for proactive
public health planning with their geriatrics expertise and knowledge of
long-term care and can help ensure states and local governments have
improved plans for older adults in disaster preparedness for future
pandemics and natural disasters. Furthermore, as the U.S. population
rapidly ages, access to a well-trained workforce and appropriate care
for medically complex older adults is imperative to maintaining the
health and quality of life for this growing segment of the nation's
population.
To address this issue, we ask the Subcommittee to provide a FY 2022
appropriation of at least $105.7 million for the GWEP and GACA program.
This increase in funding over FY 2021 levels would help ensure that
HRSA receives the funding necessary to carry these critically important
programs forward. Additional funding will also allow HRSA to expand the
number of GWEPs and GACAs and move towards closing the current
geographic and demographic gaps in geriatrics workforce training. As
laid out in President Biden's American Jobs Plan, the infrastructure of
care in the U.S. needs substantial investments so that access to long-
term services and supports is expanded while the healthcare workforce
is adequately supported and prepared to care for us all as we age.
research funding initiatives
National Institutes of Health/National Institute on Aging (additional
$500 million for aging research efforts and a minimum increase
of $289 million for Alzheimer's disease and related dementias
research)
The institutes that make up the NIH, and specifically the NIA, lead
the national scientific effort to understand the nature of aging and to
extend the healthy, active years of life. As a member of the Friends of
the NIA (FoNIA), a broad-based coalition of aging, disease, research,
and patient groups committed to the advancement of medical research
that affects millions of older Americans--the AGS urges you to include
an increase of at least $500 million in the FY 2022 budget for
biomedical, behavioral, and social sciences aging research efforts
across NIH and a minimum increase of $289 million for research on
Alzheimer's disease and related dementias over the enacted FY 2021
level.
The federal government spends a significant and increasing amount
of funds on healthcare costs associated with age-related diseases. By
2050, for example, the number of people age 65 and older affected by
dementia is estimated to reach 12.7 million cases--nearly double the
number in 2021--and is projected to cost $355 billion which does not
include the $256.7 billion in unpaid caregiving by family and
friends.\5\ Further, chronic diseases related to aging, such as
diabetes, heart disease, and cancer continue to afflict 80 percent of
people age 65 and older \6\ and account for more than 75 percent of
Medicare and other federal health expenditures.\7\ Continued and
increased federal investments in scientific research will ensure that
the NIH and NIA have the resources to conduct groundbreaking research
related to the aging process, foster the development of research and
clinical scientists in aging, provide research resources, and
communicate information about aging and advances in research on aging.
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\5\ Alzheimer's Association. 2021 Alzheimer's Disease Facts and
Figures. Alzheimers Dement. 2021; 17(3):327-406. https://doi.org/
10.1002/alz.12328.
\6\ National Prevention Council. Healthy Aging in Action: Advancing
the National Prevention Strategy. Available at https://www.cdc.gov/
aging/pdf/healthy-aging-in-action508.pdf. Published November 2016.
\7\ Erdem, E, Prada, SI, Haffer, SC. Medicare Payments: How Much Do
Chronic Conditions Matter?. Medicare & Medicaid Research Review.
2013;3(2). http://dx.doi.org/10.5600/mmrr.
003.02.b02.
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Additionally, the AGS supports no less than a $3.3 billion increase
over the enacted FY 2021 level in the FY 2022 budget for total spending
at NIH for current institutes and operations. We believe that a
meaningful increase in NIH-wide funding, in combination with aging and
increase in prevalence of diseases, will be essential to sustain the
research needed to make progress in addressing chronic disease,
Alzheimer's disease, and related dementias that disproportionately
affect older people.
Strong support such as yours will help ensure that every older
American is able to receive high-quality care. We greatly appreciate
the Subcommittee for the opportunity to submit this testimony.
______
Prepared Statement of the American Heart Association
Chair Murray, Ranking Member Blunt, and members of the
subcommittee, thank you for the opportunity to testify today. My name
is Dr. Keith Churchwell, and I am President of Yale New Haven Hospital
and a volunteer for the American Heart Association where I Chair the
National Advocacy Committee. As a cardiologist for over 25 years, a
hospital administrator who has worked in a number of roles across the
country to improve and expand care for our patients, along with more
than 20 years as a volunteer with the American Heart Association, I
understand firsthand the burden of heart disease as the world's leading
killer, and the importance of research and prevention.
I'm pleased to testify today on two specific opportunities to
improve Americans' health in the fiscal year (FY) 2022 Labor, Health
and Human Services, Education and Related Agencies appropriations bill.
I respectfully request you work over the next three years to triple the
budget of the Centers for Disease Control and Prevention (CDC) National
Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) to
$3.75 billion. I also respectfully request that, within this increase,
you provide $20 million in new funding to expand an existing COVID-19
Cardiovascular Disease (CVD) registry in partnership with NCCDPHP.
funding for the national center for chronic disease prevention and
health promotion
Chronic diseases represent 7 of the 10 leading causes of death,\1\
and account for 90% of the nation's $3.8 trillion in annual health care
costs.\2\ Heart disease remains the number one cause of death in the
United States, with approximately 655,000 individuals in America dying
from heart disease each year. In 2018, stroke accounted for about 1 of
every 19 deaths in the United States.\3\ Chronic diseases are best
managed by consistent access to health care services and treatments,
for example, a 10% increase in hypertension treatment could prevent
14,000 deaths each year.\4\
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\1\ Centers for Disease Control and Prevention. Leading causes of
death. Morality in the United States, 2019. Accessed online February
17, 2021.
\2\ Buttorff C, Ruder T, Bauman M. Multiple Chronic Conditions in
the United States. Santa Monica, CA: Rand Corp.; 2017 and Martin AB,
Hartman M, Lassman D, Catlin A. National Health Care Spending In 2019:
Steady Growth for The Fourth Consecutive Year. Health Aff.
2020;40(1):1-11.
\3\ Heart Disease and Stroke Statistics-2021 Update: A Report From
the American Heart Association https://www.ahajournals.org/doi/10.1161/
CIR.0000000000000950.
\4\ Call to Action: Urgent Challenges in Cardiovascular Disease: A
Presidential Advisory From the American Heart Association, Mark
McClellan, MD, PhD, Nancy Brown, BS, Robert M. Califf, MD, MACC, John
J. Warner, MD, FAHA (2019) https://www.ahajournals.org/doi/10.1161/
CIR.0000000000000652.
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My positions at Yale New Haven Hospital and the American Heart
Association have provided me a unique perspective on what individuals
and families need to prevent disease, cure illness, and manage chronic
health conditions, and I can personally attest to the importance of
cardiovascular disease prevention programs specifically supported by
the CDC. The burden of chronic disease is growing faster than our
ability to ameliorate the growth, putting an increasing strain on the
health care system, health care costs, our productivity, educational
outcomes, military readiness and well-being.\5\ Current funding for CDC
NCCDPHP falls far short of what is needed to prevent chronic disease,
slow its spread, and protect patients. The COVID-19 pandemic has only
exacerbated these challenges, and the underfunding of NCCDPHP has made
the nation more vulnerable to the pandemic. For example:
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\5\ Heidenreich PA, Trogdon JG, Khavjou OA, et al. Forecasting the
future of cardiovascular disease in the United States: a policy
statement from the American Heart Association. Circulation.
2011;123:933-944.
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--COVID-19 poses elevated health risks for people with chronic
conditions-including severe illness and death-and may lead to
heart failure, stroke, kidney failure, chronic lung disease,
blood pressure abnormalities, neurological conditions, and
other long-term health complications in people who have
survived the virus.
--Deaths from ischemic heart disease and hypertensive diseases in the
United States increased during the COVID-19 pandemic, while
globally, COVID-19 was associated with significant disruptions
in cardiovascular disease testing, diagnosis and timely
treatment.\6\
---------------------------------------------------------------------------
\6\ COVID-19 Pandemic Indirectly Disrupted Health Disease Care.
American College of Cardiology. January 11, 2021. Accessed online
February 17, 2021.
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After more than a decade of stagnant funding, a congressional
commitment to triple CDC NCCDPHP's budget over the next three fiscal
years is long overdue to respond to the increasing threat chronic
diseases pose to Americans. A robust investment, appropriate to the
magnitude of the problem, will allow CDC NCCDPHP to fulfill its mission
by expanding the current patchwork of existing programs nationwide and
by implementing new programs to address emerging health challenges,
including the emerging chronic disease cohort of COVID-19 ``long-
haulers.''
covid-19 cardiovascular disease registry
Since the start of the pandemic, researchers have made great
advances in our knowledge of the disease characteristics, associated
health risks, and appropriate mitigation and treatment of COVID-19. We
have learned that COVID-19 has a disproportionate impact on patients
who face endemic inequities, such as lower paying and hourly wage jobs
deemed ``essential.'' Unstable or unsafe housing and decreased
availability of health care and insurance coverage also add to that
impact. COVID-19 has laid bare the health inequities that have long
affected communities of color in the United States as the burden of
COVID-19 remains higher among African Americans, American Indians/
Alaska Natives, Hispanics/Latinos, and Asian Americans and Pacific
Islanders, compared with whites.\7\
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\7\ Lopez L, Hart LH, Katz MH. Racial and Ethnic Health Disparities
Related to COVID-19. JAMA. 2021;325(8):719-720. https://
jamanetwork.com/journals/jama/fullarticle/2775687.
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In April 2020, the American Heart Association launched the COVID-19
Cardiovascular Disease (CVD) Registry, which captures data on
hospitalized COVID-19 patients' clinical characteristics, medications,
treatments, biomarkers and outcomes, and focuses on real-time, granular
data from acute care hospitals to better help clinicians and
researchers understand and provide feedback on how to best treat COVID-
19 patients. To date, the COVID-19 CVD Registry includes nearly 170
hospitals and health systems across 35 states, reporting more than
40,000 adult COVID-19 patient records. Approximately 50 percent of the
registry patients identify as Black or Hispanic, making the registry
representative of communities disproportionately affected by the
pandemic.
According to initial research based on the COVID-19 CVD registry
data, obese patients experienced some of the worst outcomes of all
patients hospitalized with COVID-19, including increased risks for
blood clots, the need for breathing assistance and dialysis, and death.
Research has already found that patients with COVID-19 who are
hospitalized with a stroke have worse outcomes than stroke patients
without COVID-19. We are also now beginning to understand the long-term
health implications of COVID-19 in the population referred to as
``long-haulers.'' These patients have an increased risk of developing
myocarditis, or inflammation of the heart, that can lead to heart
failure, thromboembolic disease or blood clots, and other lingering
health conditions.
Additional funding is needed to expand the registry infrastructure
nationally to enhance geographic representation for both urban and
rural hospitals. A more robust, representative registry will provide
clinicians and researchers with the tools to advance our understanding
of post-COVID syndromes and provide much needed insights into this new
chronic disease cohort. Once expanded, this registry also will provide
an at-the-ready, adaptable infrastructure to respond to new and
emerging public health threats. Therefore, within the new funding
provided to the CDC NCCDPHP, the American Heart Association
respectfully requests that the Committee provide $20 million to expand
the COVID-19 CVD registry nationwide to include hundreds more
hospitals-including sole community hospitals, safety net hospitals, and
disproportionate share hospitals-and support CDC NCCDPHP in collecting,
curating, analyzing, and publishing the registry data.
As the pandemic has demonstrated, chronic diseases and infectious
diseases are inextricably linked. Therefore, any efforts to improve
pandemic preparedness and prevent the spread of infectious disease must
also include efforts to prevent chronic disease, address health
disparities, and ultimately, improve underlying health and wellness for
all. A significant investment in NCCDPHP is essential to that goal. We
must make these investments if we are to preserve health, well-being,
productivity, and longevity for all in America. I thank you for the
opportunity to offer my perspective today, and for your continued
leadership.
______
Prepared Statement of the American Indian Higher Education Consortium
On behalf of the nation's 37 Tribal Colleges and Universities
(TCUs), which collectively are the American Indian Higher Education
Consortium (AIHEC), we thank you for the opportunity to share our FY
2022 funding requests. The following is a list of recommendations
including Department, program, and funding requests.
Department of Education--Office of Postsecondary Education
--Strengthening Institutions HEA Title III--Part A (Sec. 316):
$53,080,000 (discretionary)
--Perkins Career and Technical Education Programs (Sec. 117):
$15,000,000
Department of Education--Office of Indian Education
--Indian Education Professional Development Program: $20,000,000
Department of Health and Human Services
--Administration for Children and Families/Office of Head Start
TCU-Head Start Partnership Program: $8,000,000 in existing funds
Tribal Colleges and Universities: Serving Students Across Indian
Country and Rural America
Currently, 37 TCUs operate more than 75 campuses and sites in 16
states. TCU geographic boundaries encompass 80 percent of American
Indian reservations and federal Indian trust lands. American Indian and
Alaska Native (AI/AN) TCU students represent more than 230 federally
recognized Tribes and hail from more than 30 states. Nearly 80 percent
of these students receive federal financial aid, and nearly half are
first generation students. In total, TCUs serve over 160,000 American
Indians, Alaska Natives, and other rural residents each year through a
wide variety of academic and community-based programs. Funding cuts of
any amount to even one TCU program would force TCUs to scale back vital
programs and services that students rely on to complete degree and
certificate programs needed to succeed in their chosen career paths.
Any reduction in funding will threaten TCU accreditation status and
will further stretch overtaxed faculty and staff or result in cuts to
faculty and staff. The following are justifications for TCU FY 2022
funding requests.
u.s. department of education
Strengthening Tribal Colleges (HEA Title III--Part A--Section 316):
TCUs urge the Subcommittee to provide $53,080,0000 for the
Strengthening Tribal Colleges program (HEA Title III-Part A). The
Strengthening Institutions HEA Title III program for TCUs (Section 316)
is specifically designed to address the critical, unmet needs of AI/AN
students and their communities. Through this program, TCUs are able to
provide student support services, Native language preservation, basic
upkeep of campus buildings and infrastructure, critical campus
expansion, enterprise management systems, faculty for core courses, and
other necessary elements for a quality educational experience. The
Strengthening Institutions program provides formula-based aid to 35
TCUs through two funding sources: Part A discretionary funding (FY
2021, $38.08 million) and Part F mandatory funding (FY 2020, $28.2
million). In 2019, TCUs feared losing nearly half of Title III funding
with the anticipated expiration of Part F funding. Fortunately, the
``Fostering Undergraduate Talent by Unlocking Resources to Education
Act (P.L. 116-91) was signed into law on December 20, 2019, permanently
authorizing Part F mandatory funding at $30 million for TCUs. Part A
and Part F of the Title III program are essential in supporting
institutional development and student services. AIHEC strongly supports
the President Budget Request for FY 2022, and we urge the Subcommittee
to fund these programs at the President's requested levels: HEA Title
III Part A (discretionary funding) at $53,080,000 and HEA Title III
Part F (mandatory funding) at $89,000,000.
Carl D. Perkins Career and Technical Education Programs
Tribally Controlled Postsecondary Career and Technical
Institutions: AIHEC requests $15,000,000 to fund grants under Sec. 117
of the Perkins Act. Carl D. Perkins Career and Technical Education Act
provides a competitively awarded grant opportunity for Tribally
chartered career and technical institutions (Sec.117), which provide
critical workforce development and job creation, education, and
training programs to AI/ANs from Tribes and communities with some of
the highest unemployment rates in the nation.
Native American Career and Technical Education Program (NACTEP):
NACTEP (Sec. 116) reserves 1.25 percent of appropriated funding to
support AI/AN career and technical programs. The TCUs strongly urge the
Subcommittee to continue to support NACTEP, which is vital to the
continuation of career and technical education programs offered at TCUs
that provide job training and certifications to remote reservation
communities.
Office of Indian Education
Indian Education Professional Development Program: AIHEC requests
$20,000,000 for grants to TCUs and other institutions of higher
education. The Indian Education Professional Development Program,
administered by the Office of Indian Education at the U.S. Department
of Education, provides grants to institutions of higher education to
prepare and train AI/ANs to serve as teachers and school administrators
at elementary and secondary schools. There is a growing teacher
shortage across the country, especially in urban and rural communities
with high AI/AN populations, where teacher recruitment and retention
pose unique challenges. In communities with teacher shortages, existing
obstacles to student success such as inadequate facilities and limited
broadband are further compounded by overcrowded classrooms. Targeted
resources like the Indian Education Professional Development Program
help address this shortage and ensure that AI/AN students receive high-
quality elementary and secondary education.
Report Language Needed: Funding for two distinct activities is
provided under the ``Special Programs for Indian Children'' account:
the Indian Education Professional Develop Program and Native Youth
Community Projects. Despite increased funding in 2016 to the overall
account, increases were only provided to Native Youth Community
Projects; the Indian Education Professional Development Program did not
receive increased funding. In FY 2020, the Special Programs for Indian
Children account received $67,993,000, of which $13,668,000 was
allocated for the Indian Education Professional Development Program.
AIHEC requests specific report language in order to increase funding
for the Indian Education Professional Development Program, at a minimum
of $20,000,000 in FY 2022.
u.s. department of health and human services programs
Administration for Children and Families--Office of Head Start:
Tribal Colleges and Universities Head Start Partnership Program: AIHEC
requests $8,000,000 for the TCU-Head Start Partnership program. The
TCU-Head Start Partnership program was re-established with the
designation of $4,000,000 within the FY 2020 LHHS appropriations bill
and continued with $4,000,000 within the FY 2021 LHHS appropriations
bill. TCUs have had marked success in training early childhood
educators and Head Start teachers who are urgently needed across Indian
Country. In 2017, 74.5 percent of Head Start teachers nationwide held a
bachelor's degree as required by federal law; but less than 42 percent
of Head Start teachers met the requirement in Indian Country (Head
Start Region 11); only 70 percent of workers in Region 11 met the
associate-level requirements or were enrolled in associate's degree
programs, compared to 90 percent nationally. TCUs are the most cost-
effective way for filling this gap. From 2000 to 2007, the U.S.
Department of Health and Human Services provided modest funding for the
TCU-Head Start Program (42 U.S.C. 9843g), which helped TCUs build
capacity in early childhood education by providing scholarships and
stipends for Indian Head Start teachers and teacher aides to enroll in
TCU early childhood/elementary education programs. Before the program
ended in 2007 (ironically, the same year that Congress specifically
authorized the program in the reauthorization of the Head Start Act),
TCUs had trained more than 400 Head Start workers and teachers, many of
whom have since left for higher paying jobs in elementary schools.
Today, TCUs such as Salish Kootenai College (Pablo, MT) are providing
culturally based early childhood education free of charge to local Head
Start professionals. In Michigan, Bay Mills Community College provides
online education programming for $50/credit to Head Start staff
nationwide. However, many Head Start programs in Indian Country are
paying far more for other sources to provide training. With the
restoration and continuation of this modestly funded program, TCUs can
aid in building an early childhood education workforce to better serve
the education needs of AI/AN children.
Substance Abuse and Mental Health Services Administration (SAMHSA)
NEW Tribal College and University Centers for Excellence in
Behavioral Health/Substance Abuse Prevention: AIHEC requests
$10,000,000 to establish this program. The goal of the TCU Centers of
Excellence program, similar to an existing SAMHSA program for HBCUs, is
to grow a highly skilled and culturally competent AI/AN behavioral
health workforce by developing an apprenticeship-based network of TCUs
and partners from the health industry and local, Tribal, state, and
regional providers. The TCU Centers of Excellence would share best
practices in curriculum development, program implementation, and
apprenticeships; recruit students to careers in behavioral health
fields to address mental and substance use disorders; provide job
training in behavioral health fields; and prepare students to earn
credentials in behavioral health fields. The TCU Centers of Excellence
would emphasize education, awareness, workforce training, and
preparation for careers in mental and substance use treatment,
prevention, and research, including addressing opioid abuse prevention,
opioid use disorder treatment, serious mental illness, and suicide
prevention.
conclusion
Tribal Colleges and Universities provide thousands of AI/AN
students with access to high-quality, culturally appropriate,
postsecondary education opportunities, including critical early
childhood education and behavioral health programs. The modest federal
investment in TCUs has paid great dividends in terms of employment,
education, and economic development. We ask you to renew your
commitment to help move our students and communities toward self-
sufficiency and request your full consideration of our FY 2022
appropriations requests. Thank you.
______
Prepared Statement of the American Liver Foundation
summary of fiscal year 2022 appropriations recommendations
_______________________________________________________________________
--Provide the National Institutes of Health (NIH) with at least $46.1
billion and provide individual NIH Institutes and Centers, such
as NIDDK, NIMHD, and NCI with proportional discretionary
increases.
--Please support establishment and adequate funding for the new
Advanced Research Projects Agency for Health (ARPA-H) at
NIH as proposed in the Administration's Budget Request to
Congress to facilitate robust scientific progress on
cancers and other conditions.
--Provide the Centers for Disease Control and Prevention (CDC) with
at least $10 billion to facilitate timely public health efforts
along with proportional increases for CDC Centers and
Divisions, such as NCCDPHP and NCHHSTP.
--Please provide $134 million for the Division of Viral Hepatitis
at CDC.
--Please provide $120 million for the Opioid and Infectious
Diseases Program at CDC.
--Please provide $5 million for the new Chronic Disease Education
and Awareness Program at CDC.
--Provide the Health Resources and Services Administration (HRSA)
with a funding level of at least $9.2 billion and ensure that
the agency has sufficient resources to enhance organ donation
through awareness activities and partnerships.
--Please support timely committee recommendations on liver diseases
and health disparities, NASH/NAFLD, organ donation, and related
areas.
_______________________________________________________________________
Thank you for the opportunity to submit testimony on behalf of the
American Liver Foundation (ALF) and the liver disease community.
Chairwoman Murray, Ranking Member Blunt, and distinguished members of
the subcommittee, we extend our thanks for the significant investments
in HHS, particularly NIH, provided over recent years. Please maintain
this commitment and further enhances support for public health programs
as you work on appropriations for Fiscal Year (FY) 2022. Thank you
again.
about the foundation
Founded in 1976, the American Liver Foundation (ALF) is the
nation's largest patient advocacy organization for people with liver
disease. ALF reaches more than?4?million individuals each year with
health information, education and support services via its national
office and an active online presence. Recognized as a trusted voice for
liver disease patients, ALF also operates a national toll-free helpline
(800-GO-LIVER), educates patients, policymakers and the public, and
provides grants to early-career researchers to help find a cure for all
liver diseases. ALF is celebrating more than 40 years of turning
patients into survivors. For more information about ALF, please visit
liverfoundation.org.
liver facts
The liver is one of the body's largest organs, performing hundreds
of functions daily including, removal of harmful substances from the
blood, digestion of fat, and storing of energy. Non-alcoholic fatty
liver disease (NAFLD), hepatitis C, and heavy alcohol consumption are
the most common causes of chronic liver disease or cirrhosis (severe
liver damage) in the U.S. Approximately 30% of adults and 3-10% of
children have excessive fat in the liver or NAFLD which can lead to a
severe liver disease called non-alcoholic steatohepatitis (NASH).
Approximately 4.4 million Americans are living with Hepatitis B or C
but most do not know they are infected. More than 2 million Americans
are living with alcohol related liver disease. Approximately 5.5
million Americans are living with chronic liver disease or cirrhosis.
Vaccinations for hepatitis A and B and treatments for hepatitis C are
helping to change the course of this chronic life altering disease for
the patient community.
cdc chronic disease education & awareness program
Thank you for establishing the CDC Chronic Disease Education &
Awareness Program in FY 2021 and providing $1.5 million in initial
support. Many patient organizations seek valuable collaborations with
CDC that can directly impact patients and improve public health. A few
contemporary examples include raising awareness of NASH/NAFLD, and
sharing public health information that can slow or stop the progression
of various liver conditions into liver cancer. This new program
provides a competitive mechanism that allows CDC to award meritorious
cooperative agreements on an annual basis. Since there is tremendous
demand in this area, and no shortage of quality opportunities for CDC,
we ask that funding be systematically increased with $5 million
provided for FY 2022.
organ donation
Consistently, the number of organs available for transplantation on
an annual basis amounts to only a fraction of the number of patients on
the transplant list. Compounding this situation is the fact that fatty
liver disease affects a large and growing number of individuals and
makes livers unavailable for transplantation. Another complicating
factor is the fact that the rationing of cures for hepatitis ensures
that many patients who could otherwise be healthy end up on the
transplant list too and arbitrarily deny available organs to other
patients facing a variety of life-threatening illnesses. Please promote
organ donation and otherwise work to ensure Medicaid and other patients
impacted by hepatitis receive curative therapy when medically
appropriate.
the opioid epidemic
CDC has dubbed opioids and the infectious diseases that arrive in
the wake of the opioid crisis a ``dual epidemic''. This epidemic has
been further fueled by the well-documents rise in opioid abuse during
the COVID-19 pandemic. Due to the ongoing increase in rates of
injection drug use, CDC recently identified a 400% increase in rates of
hepatitis C among 20--29 year olds an 300% increase among 30--39 year
olds. A few years ago, the elimination initiative was established at
CDC, and the current funding level is $13 million. We ask that this
allocation be systematically increased along with the annual funding
for the Division of Viral Hepatitis to ensure CDC has adequate
resources to make progress.
covid-19 and liver diseases
There is a growing body of work focused on COVID-19's impact on the
liver and persistent impacts for COVID ``long haulers''. We appreciate
that a well-resourced NIH and public health response can continue to
advance research in this critical area. Moreover, in regards to
vaccination, please note that the American Association for the Study of
Liver Diseases (AASLD) recommends that providers advocate for
prioritizing patients with compensated or decompensated cirrhosis or
liver cancer, patients receiving immunosuppression such as SOT
recipients, and living liver donors for COVID-19 vaccination based upon
local health policies, protocols, and vaccine availability.
nash bill of rights
Nonalcoholic steatohepatitis or NASH is liver inflammation and
damage caused by a buildup of fat in the liver. The prevalence of NASH
has been rising and innovative treatment options have been coming to
market along with improved healthcare. To better serve patients, ALF
crafted a NASH Patient Bill of Rights that provides critical
information on non-invasive testing options and coordinating
multidisciplinary healthcare. The Foundation looks forward to working
with the U.S. Public Health Services to disseminate critical
information about NASH to patients and providers.
patient perspectives
(Alison).--Alison is now a healthy 25-year-old from Trumbull,
Connecticut, only five years ago she was near death. Alison had been
suffering for most of her life with primary sclerosing cholangitis
(PSC), a condition that left her in need of a live-saving liver
transplant. On October 19th, 2009, Alison began her new life when her
transplant was successfully performed at Yale-New Haven Hospital.
Further complications ensued. Alison needed three additional surgeries
to ensure her health and that of her new liver. Today, she is healthy.
(Kevin).--In May 2007, a medical team at New York Columbia
Presbyterian Hospital conducted its first living donor liver transplant
surgery on a bile duct cancer patient. The patient was Kevin, my
younger brother. I was the living donor. The transplant worked, but
Kevin had to endure multiple follow-up surgeries to address a bile
leakage that would not stop. But now, over ten years later, he has long
since healed and doing great. We were lucky. And we know it. Despite
advances in medical and surgical science, the demand for organs
continues to vastly exceed the number of donors. Here, in New York,
only 27% of people age 18 and over have enrolled in the New York State
Donate Life Registry. But every ten minutes another person is added to
the national transplant waiting list. We need to encourage more people
to sign up to donate organs.
(David).--In October 2014 my mother Geraldine passed away after a
very brief and completely unexpected battle with late-stage NASH. They
call NASH the ``silent killer'' and in Mom's case it was certainly
true; she was never diagnosed with any form of liver disease at all
before NASH. We had noticed some yellowing of her eyes and convinced
her to go to the doctor about a month earlier, but it took time to get
an appointment with a specialist, who checked her into a hospital upon
the visit. I founded NASHAWARE.com to help raise awareness and educate
others. If I can help even a few people it will all be worth it. But I
still want to do much more.
[This statement was submitted by Lorraine Stiehl, Chief Executive
Officer,
American Liver Foundation.]
______
Prepared Statement of the American Lung Association
summary of fiscal year 2022 appropriations recommendations
_______________________________________________________________________
$10 billion for the Centers for Disease Control and Prevention (CDC)
--National Center for Chronic Disease Prevention & Health Promotion
(NCCDPHP)
Provide $3.75 billion for NCCDPHP
-- Provide $310 million for CDC's Office of Smoking and Health
(OSH)
-- Provide $5 million for CDC's Chronic Disease Education and
Awareness Program
--National Immunization Program at CDC's National Center for
Immunization and Respiratory Diseases (NCIRD)
Provide $1.13 billion for NCIRD
--National Center for Environmental Health (NCEH)
Provide $322 million for NCEH
-- Provide $110 million for CDC's Climate and Health Program
-- Provide $35 million for CDC's National Asthma Control Program
(NACP)
$46.1 billion for the National Institutes of Health (NIH)
--Provide $3.94 billion for the National Heart, Lung, and Blood
Institute
--Support establishment of, and adequate funding for, the new
Advanced Research Projects Agency for Health (ARPA-H) at NIH
_______________________________________________________________________
The American Lung Association is the leading public health
organization working to save lives by improving lung health and
preventing lung disease through education, advocacy and research.
Chairwoman DeLauro, Ranking Member Cole, and distinguished members of
the subcommittee, we extend our thanks for the significant investments
in the Department of Health and Human Service (HHS), including the
robust response to the COVID-19 pandemic. Please maintain this
commitment and further enhance support for public health programs as
you work on appropriations for Fiscal Year (FY) 2022. The American Lung
Association also asks for your leadership in opposing all policy riders
that would weaken key lung health protections.
The COVID-19 pandemic has underscored the need for significant and
sustained investments in our nation's public health infrastructure,
especially at CDC. For years, the Lung Association has requested for
robust CDC funding. Unfortunately, funding for CDC has remained
stagnant, and the failure to adequately invest has become evident
during the public health emergency that has taken the lives of over a
half a million people in the US. We ask that CDC funding be increased
to at least $10 billion for fiscal year 2022. This funding must be in
addition to, not in lieu of, emergency funds to respond to the current
pandemic.
The COVID-19 pandemic has also highlighted the importance of
preventing and managing chronic lung conditions. Individuals living
with certain lung diseases and people who smoke are among the most at
risk for severe illness from COVID-19. Research also shows that long-
term exposure to air pollution leads to worse COVID-19 outcomes. The
Lung Association recognizes the tremendous challenges Congress has
faced in responding to the pandemic and appreciates all that it has
done thus far. Continued investment in CDC programs that help smokers
quit; promote asthma control; support prevention and treatment of lung
and other chronic diseases, including chronic obstructive pulmonary
disorder (COPD) and lung cancer; and prepare for and respond to the
health impacts created by a warming climate is vital.
The American Lung Association strongly supports substantial federal
investments in key public health and biomedical research activities,
especially at CDC and NIH, respectively. For FY22, the Lung Association
encourages Congress to take a balanced approach in its increases for
these vital agencies and urges Congress to make significant investments
in public health programs at CDC.
Provide $10 billion for the Centers for Disease Control and
Prevention (CDC): The nation is relying on CDC more than ever before.
CDC is faced with unprecedented challenges and responsibilities,
especially in the respiratory space. Consequently, the American Lung
Association strongly supports the CDC Coalition's request of $10
billion for CDC for FY22 and sustained, robust and predictable funding
moving forward annually.
Provide $3.75 billion for National Center for Chronic Disease
Prevention and Health Promotion (NCCDPHP): In 2019, COPD was one of
seven chronic diseases included in the top 10 causes of death in the
United States. Chronic diseases can be prevented and/or managed through
supportive public health interventions including tobacco prevention and
cessation; however, they continue to be a major problem in the United
States. Over 90% of the nation's $3.8 trillion in annual health care
costs result from chronic diseases. The American Lung Association
strongly supports tripling the NCCDPHP budget over three years (FY22-
FY24). Such funding will allow NCCDPHP to fulfill its mission by
expanding the current patchwork of existing programs to all
jurisdictions nationwide and by implementing new efforts to address
health challenges currently without programs, including the chronic
disease cohort of COVID-19 ``long-haulers.'' It will also enable a
significant investment in CDC's Social Determinants of Health (SDOH)
program, which seeks to work with communities to identify and remedy
SDOH.
Provide $310 million for CDC's Office of Smoking and Health (OSH):
One in four high school students continues to use at least one tobacco
product. OSH is the lead federal agency for tobacco prevention and
control. The American Lung Association is appreciative of the $7.5
million increase in funding for OSH in FY21 and asks for an additional
$72.5 million for FY22. The additional funding will be used to continue
to address the e-cigarette pandemic, to enhance the ``Tips from Former
Smokers'' campaign so that it can be run year-round, to invest in youth
prevention efforts and to work to eliminate health inequities among
racial, ethnic, sexual, rural and socio-economic groups.
Provide $5 million for CDC's Chronic Disease Education and
Awareness Program: Far too many individuals in the United States have
or are at risk of potentially devastating chronic diseases without
knowing. COPD is one of the leading causes of death and disability in
the United States. Approximately 16 million people in the United States
have COPD, and millions more remain undiagnosed. Given this significant
gap in knowledge, the Lung Association greatly appreciates the creation
and funding of the Chronic Disease Education and Awareness competitive
grant program at CDC in FY21. In FY22, the Lung Association asks for
this program to be increased to $5 million to continue the momentum and
allow CDC to expand its work with stakeholders to respond to chronic
diseases, such as COPD, that do not have standalone programs.
Provide $110 million for CDC's Climate and Health Program: CDC's
Climate and Health Program is the only HHS program devoted to
identifying the risks and developing effective responses to the health
impacts of climate change (which include worsening air pollution;
diseases that emerge in new areas; stronger and longer heat waves; and
more frequent and severe droughts and wildfires) and provides guidance
to states in adaptation. Currently, projects in 16 states and two city
health departments develop and implement health adaptation plans and
address gaps in critical public health functions and services.
Unfortunately, the level of investment thus far has been insufficient
for this program to reach its full, possibly lifesaving, potential. The
President's budget requests $110 million, which would allow CDC to
implement a 50-state climate and health program.
Provide $35 million for CDC's National Asthma Control Program
(NACP): It is estimated that 24.8 million Americans currently have
asthma, of whom 5.5 million are children. The NACP tracks asthma
prevalence promotes asthma control and prevention and builds capacity
in states. This program has been highly effective: asthma mortality
rates have decreased despite the rate of asthma increasing. Additional
funding would allow approximately four to five additional states beyond
the current 25 states and localities to be funded to implement these
lifesaving programs.
Provide $1.13 billion for the National Immunization Program at
CDC's National Center for Immunization and Respiratory Diseases
(NCIRD): The success of the nation's vaccination programs has enabled
many individuals to forget about the impact of many vaccine preventable
diseases, such as polio, that once wreaked havoc. The COVID-19
pandemic, however, has provided a stark reminder of the need and
significance of vaccines and a robust national vaccination program. The
National Immunization Program must receive strong and sustained
funding. The Lung Association asks for $1.13 billion for NCIRD to
enhance COVID19 vaccinations, bolster the nation's immunization
infrastructure and address any gaps in routine immunizations that may
have emerged as a result of the pandemic.
Provide $46.1 billion for the National Institutes of Health (NIH):
The Lung Association supports increased funding for NIH research on the
prevention, diagnosis, treatment and cures for tobacco use and all lung
diseases including lung cancer, asthma, COPD, pulmonary fibrosis,
influenza and tuberculosis. The Lung Association also supports robust
funding increases for the individual institutes within NIH, recognizing
the need for research funding increases to ensure the pace of research
is maintained across NIH. Lastly, the Lung Association urges increased
funding for lung cancer research in addition to the Cancer Moonshot and
the All of Us Program.
Thank you for your consideration of our recommendations. Below
please find a vignette demonstrating the importance of CDC programs.
sharon l. from oklahoma: lung cancer & covid-19 survivor
``I now live with cancer. I am not a cancer patient; I am a patient who
has cancer.''
Sharon was diagnosed with Stage 4 lung cancer in October 2015.
After six rounds of aggressive chemotherapy, followed by another two
rounds shortly thereafter, Sharon is currently six years out from her
diagnosis and living without the need for additional treatment. This
past year, Sharon became one of the over 32 million individuals in the
United States diagnosed with COVID-19.
``I can't emphasize how important funding for the CDC is. Having
had COVID, it is even more important, but it has always been important
to me.''
Sharon and husband tenaciously fought to quit smoking, her husband
with the help of a CDC-funded quitline, and they were ultimately
successful in doing so. From her experiences, Sharon believes that
public health programs are critical to raising awareness about lung
cancer prevention and increasing tobacco cessation.
``What the CDC does with smoking cessation is vitally important, so
people don't end up like me, thinking they have 14 months to live and
watching every plan they have for growing old with their husband flash
before their eyes. It is vitally important. Public health is important
for everybody. You either pay for it now, or you pay for it at the end.
And it always costs more at the back end than now.''
michigan asthma prevention and control program (miapcp)
Michigan is one of the 23 states that receive funding through the
National Asthma Control Program (NACP). Through funding from CDC,
Michigan was able to create the Asthma Initiative of Michigan website,
www.GetAsthmaHelp.org, which enables access to a plethora of resources
for those struggling with asthma. The MiAPCP has also worked to
facilitate and support Managing Asthma Through Case-Management in Homes
(MATCH) throughout parts of Michigan with the highest burden of asthma.
Through MATCH programs, individuals can benefit from home visits, an
environmental assessment, access to a certified asthma educator, and a
physician care conference. As a result, Michigan saw a 60% decrease in
asthma-related emergency room visits, 82% decrease in hospitalizations
and a 58% decrease in the number of children who missed one or more
school days due to asthma.
``Interventions and policy efforts by our program that impact
asthma care and environments cannot be sustained without CDC's
support.''
--John Dowling, Lead Asthma Coordinator of the MiAPCP
Most recently, MiAPCP launched a cohesive effort to improve asthma
surveillance and data collection.
[This statement was submitted by Harold P. Wimmer, National
President and CEO, American Lung Association.]
______
Prepared Statement of the American Massage Therapy Association
The American Massage Therapy Association (AMTA) appreciates the
opportunity to submit written testimony for the record to the Senate
Subcommittee on Labor, Health and Human Services, and Education
Subcommittee in support of continued robust funding in FY 2022 for the
National Center for Complementary and Integrative Health (NCCIH) within
the National Institutes of Health (NIH) as well as for suggested report
language for both NCCIH as well as the Centers for Disease Control
(CDC).
Established in 1943 and numbering over 95,00 members, AMTA works to
advance the massage therapy profession through the promotion of fair
and consistent licensing of massage therapists in all states, public
education on the benefits of massage therapy, and support of research
to advance knowledge about massage therapy. Massage therapists are
currently licensed in 46 states and the District of Columbia.
We appreciate and acknowledge the Committee's ongoing support for
massage therapy, including past report language urging the adoption of
recommendations from the groundbreaking and widely supported 2019 HHS
final report from the Pain Management Best Practices Task Force (Task
Force). Unfortunately, most recommendations from that task force--
including those that support inclusion of massage therapy and other
integrative and complementary health treatments for pain--have still
not been adopted.
COVID-19 has exacerbated the already existing public health crisis
of acute and chronic pain from delayed access to health care, as well
as a rise in substance abuse and overreliance on opioids. We encourage
the Committee to include report language in the FY 2022 bill that
focuses on the need for greater public awareness on treatment options
for pain that include complementary and integrative approaches such as
massage therapy. We request the Committee to direct NIH to coordinate
with the DoD and VA to launch a much-needed public awareness campaign
about these non-opioid treatment options and to widely disseminate the
Task Force recommendations to health care providers and public health
stakeholders. Last, we request the Committee's continued support to
direct all relevant HHS agencies to update their pain management
practices to reflect the Task Force recommendations, including those
that support massage therapy.
We also support the inclusion of report language accompanying the
FY 2022 bill that would direct the CDC to collect and publish
population research data that provides a comprehensive assessment of
the nature of pain management, who is affected by pain, and direct and
indirect costs to society related to pain.
Over recent years, research continues to increase support for
massage therapy, which has thus increased policymakers' awareness of
the benefits of massage therapy as a non-pharmacologic alternative to
opioid use to manage pain. As noted above, massage is specifically
addressed throughout the 2019 Task Force report and is even included in
the Task Force ``Pain Management Toolbox'' as an example of a treatment
modality that should be considered as part of an overall integrative
and collaborative care model to ensure optimal patient outcomes.
https://www.hhs.gov/sites/default/files/pmtf-final-report-2019-05-
23.pdf. NCCIH notes the value of massage therapy for a wide variety of
health conditions involving both acute and chronic pain, including low
back pain, neck and shoulder pain, symptoms and side effects associated
with certain cancers, fibromyalgia, HIV/AIDS, among others.
In addition to NIH, massage therapy is supported by the American
College of Physicians and The Joint Commission. Massage is currently
utilized in many nationally renowned hospitals and other institutions,
such as the Mayo Clinic, M.D. Anderson Cancer Center, Duke Integrative
Medicine, the Cleveland Clinic, and Memorial Sloan Kettering Cancer
Center. Finally, CMS includes massage therapy provided by a state
licensed massage therapist as a supplemental benefit for pain
management in Medicare Advantage plans, and massage is also a covered
benefit for our nation's veterans and active-duty military personnel.
Despite the demonstrated value and efficacy of massage therapy
through research, we know that more needs to be done. As recently as
last August, a national survey of 1,581 people with pain indicated that
massage therapy is the most desired treatment for pain (at 48.4%,
followed by pain physician at 32.9% and acupuncture at 29%), but
unfortunately a majority of those surveyed indicated that cost
prevented them accessing massage therapy. This underscores the
disconnect between the best practices that already exist in pain
management and those that are realistically available to patients, due
to cost and lack of 3rd party insurance coverage, as well as
insufficient provider awareness of the benefits of massage and other
complementary therapies.
For over 30 years, the Massage Therapy Foundation (MTF) a 501(c)
(3) organization, working with AMTA, has provided over $1 million in
research grants studying the science behind therapeutic massage. This
seed money has funded needed research on a wide range of topics
including: the benefits of massage therapy for pediatric populations,
patients with heart failure, and those with muscle atrophy, among
others. Many of these efforts have been specifically designed to
include racially diverse and underserved populations.
We know that massage therapy can improve health outcomes and is
also among the most cost-effective therapies that can save health care
expenditures in the long run. Massage therapy demonstrably reduces or
mitigates reliance on opioids to address pain. Massage therapy can
serve as a 'portal' to increase patient involvement in other important
health activities, e.g. research shows that patients who obtain massage
are more likely to be able to move better, and thus engage in other
physician-prescribed activities such as corrective exercise programs.
We encourage a sustained and robust finding stream for NIH and
NCCIH that supports the role of integrative therapies to help mitigate
opioid abuse and misuse, and which will enable continued advancements
in the use of non-pharmacologic therapies such as massage.
Thank you for your consideration, and AMTA would be happy to
provide more information as needed.
Sincerely,
James Specker, AMTA Director, Industry and Government Relations at
[email protected].
______
Prepared Statement of the American National Red Cross and
the United Nations Foundation
Chairwoman Patty Murray, Ranking Member Roy Blunt, and Members of
the Subcommittee on Labor, Health and Human Services, Education and
Related Agencies, the American Red Cross and the United Nations
Foundation appreciate the opportunity to submit testimony. We are
writing to request that Congress invest $60 million for CDC's global
measles and rubella elimination efforts for fiscal year 2022.
The American Red Cross and United Nations Foundation recognize the
leadership that Congress has shown in funding CDC in prior years and
urge Congress to protect the CDC's funding necessary for their global
measles elimination activities for FY2022 at $60 million, which is part
of the overall Global Immunization Division line.
covid-19 environment
COVID-19 has had an unprecedented impact on global immunization
programs. As of June 1st twenty-three measles and rubella vaccination
campaigns that were scheduled for 2020 continue to be postponed as a
result of the COVID-19 pandemic, leaving an estimated one hundred and
thirty-five million children unvaccinated and vulnerable to the
diseases. This growing immunity gap is creating a looming cliff in
global public health, as social distancing measures are lowered, the
measles virus will quickly spread amongst unvaccinated individuals and
communities. Because the measles virus is one of the most transmissible
human viruses--with each infectious person capable of infecting as many
as 18 unvaccinated individuals--a drastic increase in measles outbreaks
around the world is anticipated. Failing to close these immunity gaps
will leave millions of children at risk and will compromise U.S. global
health security by disrupting economies, trade, and country stability,
and increasing the likelihood of the virus infecting U.S. communities.
Investments that will quickly close these global immunity gaps will
help to ensure that gains made in reducing maternal and child mortality
and morbidity are maintained, and that the global health infrastructure
established through these investments is preserved and strengthened.
Among other benefits, this global health architecture is vital to
protecting global health security. Measles investments have established
networks of laboratories around the world capable of processing
diagnostics, and has bolstered the global public health workforce of
trained professionals and volunteers who are often the first responders
during health crises. During the pandemic, for instance, these assets
and infrastructure investments were pivoted to detect and test cases of
COVID-19, giving vulnerable countries a head start in their pandemic
response. With this context in mind, we respectfully provide the
following justification for continued robust investment in CDC's global
measles and rubella elimination efforts.
why measles and rubella?
U.S. leadership has saved the lives of 25.5 million children
between 2000 and 2019, with the Measles & Rubella Initiative driving
measles deaths down by 62%.
Measles is a highly contagious disease that can cause blindness,
swelling of the brain, and death. Nine out of ten people who are not
immune to measles will contract the disease if they come into contact
with a contagious person, and there are long-term damages to the immune
system for those who contract the virus. The rubella virus is a leading
infectious cause of birth defects in the world despite availability of
an affordable, effective vaccine since 1969. Every day, roughly 567
children still die of measles-related complications. When rubella
occurs early in a pregnancy, it can cause miscarriages, stillbirths, or
a constellation of severe birth defects as part of congenital rubella
syndrome (CRS) that can impact vision, hearing, heart health, overall
development. Each year roughly 100,000 babies are born with CRS despite
the preventable nature of the disease.
Since 2000, measles vaccines have been the single greatest
contribution in reducing preventable child deaths globally. We have had
safe and effective vaccines against both rubella and measles for over
50 years, but unfortunately vaccination rates globally have stagnated
for over a decade.
domestic implications
In the U.S., measles control measures have been strengthened, and
endemic transmission of measles cases has been eliminated since 2000
and rubella in 2002. However, importations of measles cases into this
country continue to occur each year. In 2019, for example, the U.S.
reported 1,282 cases of measles in 32 states, the largest number of
cases since 1992. Major outbreaks in New York and Washington state have
been linked to importation of the disease by unvaccinated U.S.
residents returning from trips to Israel and Ukraine. Controlling
measles and rubella around the world reduces the likelihood of similar
disease importations in the future.
Responding to measles outbreaks is resource intensive and costly
for health systems, including in the U.S. In a literature review that
included 10 studies on measles outbreaks from 2001 to 2018 in the U.S.,
researchers estimated the cost per case to range from about $7,000 to
$76,000 and the total cost per outbreak ranged from $10,000 to $1
million. A recent study of a 72-case outbreak in the U.S. cost local
public health and government authorities an estimated $3.4 million for
response activities, medical costs, and productivity losses.
the measles & rubella initiative
The Measles & Rubella Initiative (M&RI)--which includes the
American Red Cross, CDC, UNICEF, the United Nations Foundation, and
WHO, all working in collaboration with Gavi, the Vaccine Alliance as
well as the Bill & Melinda Gates Foundation--supports countries to
prevent, identify, and respond to measles outbreaks through key
interventions like surveillance, supplementary vaccination campaigns,
and emergency response.
M&RI has achieved outstanding results by helping to vaccinate
nearly 3 billion individuals in over 90 countries since 2001, saving
the lives of more than 25.5 million children. In part due to M&RI,
global measles mortality has dropped 62%, from an estimated 545,000
deaths in 2000 to an approximately 207,000 in 2019 (the latest year for
which data is available), mostly children under the age of five. During
this same period, measles deaths in Africa fell by 57%.
Despite these gains, we continue to see unfortunate and preventable
deaths and complications due to both measles and rubella. In 2019,
every day approximately 567 children died of measles-related
complications. These deaths could have been prevented with a safe,
effective, and inexpensive vaccine that is typically available for less
than $2 USD in lower income countries, which protects against both
measles and rubella.
Thanks to M&RI leadership, most measles vaccination campaigns have
been able to reach more than 90% of their target populations. Countries
recognize the opportunity that measles vaccination campaigns provide in
reaching mothers and young children and integrating the campaigns with
other life-saving health interventions. These include administering
vitamin A, which is crucial for preventing blindness in under nourished
children; de-worming medicine to reduce malnutrition; doses of oral
polio vaccines; distributing insecticide treated bed nets to help
prevent malaria and screening for malnutrition. The provision of
multiple child health interventions during a single campaign is far
less expensive than delivering the interventions separately and has a
far greater impact on a child's health.
In addition to the lifesaving benefits of the measles-rubella
vaccine, immunization makes sound economic sense. A 2016 Johns Hopkins
University study compared the costs for vaccinating against 10 disease
antigens in 94 low- and middle-income countries between 2011-2020
versus the costs for estimated treatments of unimmunized individuals
during the same period. Their findings show, on average, every $1
invested in these 10 immunizations produces $44 in savings in
healthcare costs, lost wages, and economic productivity. The return on
investment for measles immunization was found to be the greatest with
$58 saved for every $1 invested.
Securing sufficient funding for measles and rubella-elimination
activities both globally and nationally is critical. The decrease in
donor funds available at a global level to support measles and rubella
elimination activities makes increased political commitment and country
ownership of the activities critical for achieving and sustaining the
goal of increasing measles vaccination coverage to 95%. Implementation
of timely measles and rubella vaccination campaigns is increasingly
dependent upon countries funding these activities locally, which can be
challenging under such downward financial pressure.
If such challenges are not addressed, the remarkable gains made
since 2000 will be lost and a major resurgence in measles death and
disability will occur. The combined factors of a highly contagious
disease, growing immunity gaps exacerbated by COVID-19 disruptions, and
our highly interconnected world means measles is poised to spread
quickly, with devastating results that could even threaten countries
that have already eliminated the disease. The threat of importation of
measles was one of the reasons that the Global Health Security Agenda
has selected measles as an important indicator of whether a country's
routine immunization system is able to effectively reach and vaccinate
all its children.
the role of cdc in global measles mortality reduction
Since FY 2001, Congress has generously provided funding to protect
children and their families from the threat of measles and rubella in
developing countries, thereby also protecting the U.S. population from
the threat of measles importations. Funding for measles and rubella
globally has remained level since FY 2010 at $50 million dollars. The
COVID-19 pandemic has gravely disrupted immunization systems around the
world, leaving millions of children vulnerable to measles and other
vaccine-preventable diseases. We must quickly ``catch up'' vaccination
coverage rates to reach unvaccinated populations and prevent
devastating measles outbreaks. The CDC plays an essential role within
this space by providing support for vaccination programs and
surveillance to detect outbreaks early and stop them at their source.
An increase in resources for these and other critical activities
provided by the CDC are needed to prevent needless childhood deaths
around the globe.
In 2019, thanks in part to U.S. funding, M&RI supported 62
immunization campaigns in 53 countries, resulting in the vaccination of
nearly 203 million children. Funding for CDC permitted the provision of
technical support to Ministries of Health that included: 1) planning,
monitoring, and evaluating large-scale measles vaccination campaigns;
2) conducting epidemiological investigations and laboratory
surveillance of measles outbreaks; 3) CDC's Global Measles Reference
Laboratory serving as the leading worldwide reference laboratory for
measles and rubella; and 4) conducting operations research to guide
cost-effective and high-quality measles and rubella elimination
programs.
Since FY10, the CDC's measles and rubella elimination program has
been funded at approximately $50 million. In FY 2022, the American Red
Cross and United Nations Foundation respectfully request an increase of
$10 million to raise funding to $60 million. This investment will allow
CDC to help countries to close the immunization gap created by COVID-
19, safeguard the progress made over the last decade and protect
Americans by preventing measles cases and deaths in the U.S. The CDC
Global Immunization Division, through which the Measles & Rubella
Initiative is funded, has been highly effective and we strongly support
fully funding this work. All the programs funded through the Global
Immunization Division budget line also help to build stronger health
systems. We respectfully request $60 million for CDC's measles
elimination activities, as part of the overall funding for the entire
Global Immunization Division account in FY2022.
Thank you for the opportunity to submit testimony, and for your
continued commitment to ending preventable death and disability from
measles and rubella.
[This statement was submitted by Koby J. Langley, Senior Vice
President,
International Services and Service to the Armed Forces, American
National Red Cross and Peter Yeo, Senior Vice President, United Nations
Foundation.]
______
Prepared Statement of the American Nurses Association
The American Nurses Association (ANA), representing the interests
of the nation's 4.2 million registered nurses, thanks Chair Murray,
Ranking Member Blunt, and the U.S. Senate Appropriations Subcommittee
on Labor, Health and Human Services, Education and Related Agencies for
the opportunity to provide written testimony for Fiscal Year (FY) 2022.
ANA is committed to advancing the nursing profession by fostering
high standards of nursing practice, promoting a safe and ethical work
environment, bolstering the health and wellness of nurses, and
advocating on health care issues that affect nurses and the public. ANA
is at the forefront of improving quality of health for all.
nursing workforce and health equity
Investments in the Title VIII Nursing Workforce Development
Programs are essential to ensuring nurses and nursing students have the
resources to tackle our nation's health care needs, remain on the
frontlines of the COVID-19 pandemic, and be prepared for the public
health challenges of the future. Funding for Title VIII has become even
more crucial during the pandemic, as these programs connect patients
with high-quality nursing care in community health centers, hospitals,
long-term care facilities, local and state health departments, schools,
workplaces, and patients' homes.
ANA believes there are multiple policy levers to eliminate or
reduce health disparities. Our Principles for Health System
Transformation \1\ call for expanded access to care through universal
coverage and other steps to improve the quality and affordability of
health care. We also believe policymakers must consider and account for
an adequate health care workforce of the future. The nursing workforce,
in particular, can play a tremendous role in efforts to create a more
equitable health care system. Nurses provide the type of care and
coordination that can help people manage their chronic conditions,
including links to community resources they need to be healthy.
Registered nurses and advanced practice registered nurses are often the
backbone of health care delivery in rural and underserved areas,
providing access to primary care, maternity care, and prevention. These
roles should be strengthened through meaningful reforms.
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\1\ https://www.nursingworld.org/4afd6b/globalassets/
practiceandpolicy/health-policy/principles-
healthsystemtransformation.pdf.
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Expanding the minority health care workforce would be one of the
most meaningful steps we could take to improve access and health care
in African American population groups. We know that positive patient
experience and trust in health care providers can be powerful drivers
of health outcomes. The National Sample Survey of Registered Nurses
recently reported an increase in the minority nursing workforce between
2008 and 2018.\2\ This is encouraging, but there is a long way to go.
An increased funding in minority nursing education, to develop a
workforce that is more reflective of the patient population would be a
first step in the right direction.
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\2\ https://bhw.hrsa.gov/data-research/access-data-tools/national-
sample-survey-registered-nurses.
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ANA is a member of the Nursing Community Coalition which is
comprised of 63 national nursing organizations who collectively
represent the cross section of education, research, practice, and
regulation within the nursing profession. Together, we respectfully
request supporting at least $530 million for the Nursing Workforce
Development Programs (authorized under Title VIII of the Public Health
Service Act [42 U.S.C. 296 et seq.] and administered by HRSA) in FY
2022.
public health infrastructure
The nation's public health infrastructure and workforce have been
underfunded for decades, and we have witnessed the highlighted impacts
of this chronic underfunding throughout the COVID-19 public health
emergency. Federal funds for state, local, and tribal public health
preparedness shrunk from $940 million in 2002 to $675 million in
2019.\3\ During the same time period, hospital emergency preparedness
was cut by nearly fifty percent, from $515 million in 2004 to $265
million in 2019. This has resulted in a loss of 55,000 public health
workers since 2008. The current COVID-19 public health emergency has
underscored that our nation must be better equipped with preparedness
and response personnel, measures and processes. A robust public health
infrastructure and workforce is not only important during the time of
crisis, but generally to address the overall health and well-being of
our population.
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\3\ https://www.tfah.org/wp-content/uploads/2020/04/
TFAH2020PublicHealthFunding.pdf.
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The public health nursing workforce touches every aspect of health
care and community well-being. Unfortunately, we can only imagine how
different the coronavirus response would have been had greater federal
public health infrastructure investment afforded availability of
sufficient numbers of nurses and other public health personnel in areas
of the greatest need. Nurses could have played an enhanced role in
encouraging and administering COVID-19 tests in high-risk populations,
conducting contact tracing at an effective pace, educating the public
about vaccine safety and all facets of COVID-19 prevention and
mitigation, informing school opening protocols, and collecting data for
feedback to pandemic response efforts.
mental health
Nurses, particularly those early in their career, continue to feel
exhausted and overwhelmed. According to the findings of an American
Nurses Foundation survey of nearly 13,000 nurses, 51 percent of nurses
surveyed continue to feel exhausted and 43 percent report feeling
overwhelmed. A breakdown of findings demonstrates that the mental
health of early-career nurses, 34 and under, is impacted most, with 81
percent reporting they are exhausted, 71 percent saying they are
overwhelmed, and 65 percent who report being anxious or unable to
relax. Nurses who are 55 and older reported some strain on their mental
health, with 47 percent reporting feeling exhausted and 31 percent
reporting they had a desire to quit.\4\
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\4\ https://www.nursingworld.org/practice-policy/work-environment/
health-safety/disaster-preparedness/coronavirus/what-you-need-to-know/
mental-health-and-wellness-survey-2/.
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ANA is a member of the Mental Health Liaison Group. We count the
American Psychiatric Nurses Association as a premier Organizational
Affiliate and many psychiatric nurses as members. We request that the
Committee approve the appropriations request put forward by the Mental
Health Liaison Group for FY 2022 for mental health and addiction
policies and programs.\5\
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\5\ https://www.mhlg.org/wordpress/wp-content/uploads/2021/04/MHLG-
FY2022-Approps-Request-Final-4.7.21.pdf.
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minority fellowship program
ANA supports funding and expanding the Minority Fellowship Program
(MFP), which is currently administered by the Substance Abuse and
Mental Health Services Administration (SAMHSA).\6\ The program provides
scholarships to minority mental health and addiction professionals in
nursing, but also in the fields of psychiatry, psychology, social work,
marriage and family therapy, counseling and addictions. The program's
mission is to increase the number of culturally competent behavioral
health professionals who provide mental health and substance use
disorders services to underserved populations.
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\6\ https://www.samhsa.gov/minority-fellowship-program/about.
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The MFP was created in 1974 to provide fellowships to minority
mental health professionals, and, since then, more than 4,400
fellowships have been issued to nurses, psychiatrists, psychologists,
social workers, marriage and family therapists, counselors, and
addiction specialists. According to HHS, minorities are less likely to
receive diagnosis and treatment for their mental illness, have less
access to and availability of mental health services, and often receive
a poorer quality of mental health care. The MFP is the only federal
program financing culturally competent mental health and substance use
disorders professionals.
ANA, along with the MFP Coalition, urges Congress to increase
funding for the MFP to $20,200,000 in FY 2022 in order to expand access
to nurses and other mental health professionals who provide culturally
competent mental health and substance abuse services to ethnic minority
populations.
Thank you for the opportunity to provide written testimony as the
Subcommittee continues its important work. If you have any questions,
please contact Ingrida Lusis, Vice President of Policy and Government
Affairs, at [email protected].
[This statement was submitted by Debbie D. Hatmaker, PhD, RN, FAAN,
Chief Nursing Officer/EVP.]
______
Prepared Statement of the American Psychological
Association Services, Inc.
The American Psychological Association (APA) is the largest
scientific and professional organization representing psychology in the
United States, with more than 122,000 researchers, educators,
clinicians, consultants, and students as its members. Our mission is to
promote the advancement, communication, and application of
psychological science and knowledge to benefit society and improve
lives.
Many programs in the Labor-HHS-Education Appropriations bill are
critical to strengthening the mental health workforce, supporting
psychology-based research and education, and improving access to needed
mental and behavioral health services, particularly for underserved
communities. As the COVID-19 pandemic continues to present broad
challenges for our nation in both the short and long term, federal
investments are needed to bolster research, expand equitable access to
primary and mental health services, and support data-informed
approaches to education and public welfare at all levels. To boost
critical research funding, support the psychology workforce, improve
access to mental and behavioral health services across the lifespan,
and address social determinants of health, APA requests the following
funding levels for FY22 within the U.S. Department of Health and Human
Services, U.S. Department of Education, and U.S. Department of Labor.
Boosting Critical Research Funding: APA requests at least $46.111
billion for NIH in FY22, including $48.9 million for the NIH Office of
Behavioral and Social Sciences Research (OBSSR). This funding would
allow OBSSR to continue leading the coordination and support of
research designed to address the social, behavioral, and economic
effects of COVID-19 and its associated containment and mitigation
efforts. Understanding these impacts will help policymakers improve
their long-term response to the pandemic and prepare more effectively
and efficiently for the country's next public health emergency. APA
encourages the Committee to resist calls to limit the availability or
use of non-human animal models in research, and to ensure this research
continues to be conducted appropriately and ethically.
APA recommends at least $700 million for the Institute of Education
Sciences (IES), which supports and disseminates scientific evidence on
which to base education policy and practice and funds innovative
research into many aspects of teaching and learning, including research
on pandemic-related learning loss. Finally, APA urges the Committee to
provide $50 million in funding shared evenly between the CDC and NIH to
conduct public health research into firearm morbidity and mortality
prevention. This research is fundamental to helping our nation better
understand and address our gun violence public health crisis.
Supporting the Psychology Workforce: The nation's mental and
behavioral health workforce must be expanded to adequately respond to
the long-term mental health and substance use disorder ramifications of
the COVID-19 pandemic, particularly the needs of long-underserved
communities like communities of color and older adults. This includes
foundational investments in higher education, as well as workforce
training programs that support the integration of behavioral
healthcare. To address this, APA supports increased funding for the
following programs within the Department of Education and HHS' Health
Resources and Services Administration (HRSA), Substance Abuse and
Mental Health Services Administration (SAMHSA).
Given the heavy burden of student loan debt, APA supports added
investments in grant programs for graduate study within the Department
of Education, including $35 million for the Graduate Assistance in
Areas of National Need (GAANN) Program. The most recent funding cycle
marked the first time in nearly a decade where psychology was among the
designated areas of national need under this program. As the mental
health impact of the pandemic continues to unfold, APA requests that
the committee again direct the Secretary to include academic areas that
fall under the Classification of Instructional Programs (CIP) 51.15
Mental Health Services in the next grant competition.
Within HRSA, APA joins the Mental Health Liaison Group (MHLG) in
urging the Committee to provide $23 million for the Graduate Psychology
Education Program; $90 million for the Behavioral Health Workforce
Education and Training (BHWET) Grant Program; and $37 million for the
Mental and Substance Use Disorder Workforce Training Demonstration.
These essential programs increase work to increase our nation's supply
of health service psychologists trained to provide integrated services
to high-need, underserved populations in rural and urban communities.
To expand access to non-pharmacological pain management to improve pain
care and reduce the incidence of opioid use disorders, APA recommends
$10 million for a program for education and training in pain care, as
authorized by the SUPPORT Act under Section 759 of the Public Health
Service Act (42 U.S.C. 294i).
Within SAMHSA, APA requests $20.2 million for the Minority
Fellowship Program (MFP). This increase will support the program's dual
mission to both increase the diversity of the mental and behavioral
health workforce while improving access to mental health and substance
use disorder services in underserved communities.
Improving Access to Mental and Behavioral Health Care Across the
Lifespan: Given the rise in COVID-related mental health concerns, APA
joins MHLG in requesting $833 million for SAMHSA's Community Mental
Health Block Grant (MHBG) and $1.9 billion for the Substance Abuse
Prevention and Treatment (SAPT) Block Grant in FY22. To address rising
suicide rates, we urge the Committee to provide $240 million for the
National Suicide Prevention Lifeline; $5 million for 988
implementation, $37 million for the State/Tribal Youth Suicide
Prevention Program; $6.7 million for the Campus Mental and Behavioral
Health Program; and $9.3 million for the Suicide Prevention Resource
Center.
To ensure that our K-12 students receive a well-rounded education,
and access to school-based mental health services and programs that
foster safe and healthy schools, APA requests $2 billion for Title IV-
A, the Student Support and Academic Enrichment (SSAE) block grant.
Additionally, to increase the number of mental health providers working
in school settings, APA requests $606 million for the Safe Schools
National Activities Program in order to support new competitions for
the School Based Mental Health Services Professional Demonstration
Grant and the School-Based Mental Health Services Grant Program. APA
also urges the Committee to include $15.5 billion for Part B (Grants to
States) of the Individuals with Disabilities Education Act (IDEA) to
help provide an equitable education for students with disabilities.
Given that maternal mental health conditions are the most common
complication of pregnancy and childbirth, APA joins the Maternal Mental
Health Leadership Alliance and more than 100 other organizations in
requesting $5 million for HRSA's Maternal Mental Health Hotline, and
$10 million for the Screening and Treatment of Maternal Depression and
Related Behavioral Disorders Program. APA urges to Committee to provide
$750 million for Title V Maternal and Child Health Services Block Grant
Program, which supported 92% of all pregnant women in the U.S. in FY19.
Finally, APA urges the Committee to provide much-needed funding to
support Mental Health Parity and Addiction Equity Act (MHPAEA)
enforcement. Within the DOL's Employee Benefits Security
Administration, APA requests $25 million for MHPAEA enforcement, with
10% allocated to Office of Solicitor for parity litigation. To support
MHPAEA enforcement within HHS, APA requests $10 million for CMS' Center
for Medicaid and CHIP Services (CMCS).
Addressing Social Determinants of Health & Social Safety Net:
Within HHS' Administration for Children and Families, APA supports $1.7
billion for the Social Services Block Grant, which provides vital
social services, such as protective services agencies and special
services to people with disabilities. In addition, APA urges the
Committee to provide $10.7 billion for the Head Start Program, $5.9
billion for Preschool Development Grants, and $500 million for CAPTA
Title I to support state child abuse prevention and treatment.
To expand the reach out various federal HIV programs, APA requests
$100 million for the CDC Division of Adolescent and School Health
(DASH), to increase access to health services, implement evidence-based
sexual health education, and foster supportive environments for young
people to learn. APA also supports $160 million for the SAMHSA Minority
AIDS Initiative to expand efforts at preventing domestic HIV
transmission and to increase treatment options for those living with
co-morbid conditions. APA urges the Committee to provide $120 million
for the infectious diseases and opioid program at CDC. Currently funded
at a level well below its actual need, this program increases
prevention, testing, and linkages to provide a strong ground-level
response to the intersecting crises of opioid addiction, HIV, and
hepatitis. Finally, to strengthen public health surveillance
activities, APA requests $250 million for the CDC's Data Modernization
Initiative (DMI).
[This statement was submitted by Katherine B. McGuire, Chief
Advocacy Officer, American Psychological Association Services, Inc.]
______
Prepared Statement of the American Public Health Association
APHA is a diverse community of public health professionals that
champions the health of all people and communities. We are pleased to
submit our request of at least $10 billion for the Centers for Disease
Control and Prevention and at least $9.2 billion for the Health
Resources and Services Administration in FY 2022. Robust funding for
CDC and HRSA programs that promote public health and prevention,
support surveillance of infectious disease and bolster America's public
health workforce will be critical in addressing both the short-term and
long-term health impacts of COVID-19 and the many other health
challenges we face as a nation. We are thankful for the emergency
supplemental funding provided to CDC and HRSA to support the nation's
response to COVID-19 and we urge the committee to ensure that all CDC
and HRSA programs are adequately funded in FY 2022.
Centers for Disease Control and Prevention: CDC provides the
foundation for our state and local public health departments,
supporting a trained workforce, laboratory capacity and public health
education communications systems. It is notable that more than 70% of
CDC's budget supports public health and prevention activities by state
and local health organizations and agencies, national public health
partners and academic institutions. We urge a funding level of at least
$10 billion in FY 2022. We are grateful for the important increases
provided for CDC programs in FY 2021 and for the critical emergency
funding provided to the agency to address COVID-19. We urge Congress to
build upon these investments to strengthen all of CDC's programs, many
of which remain woefully underfunded. We also urge your continued
support for the Prevention and Public Health Fund which currently makes
up approximately 11% of CDC's budget.
CDC serves as the command center for the nation's public health
defense system against emerging and reemerging infectious diseases.
From aiding in the surveillance, detection and prevention of the
current COVID-19 outbreak globally and in the U.S. to playing a lead
role in the control of Ebola in West Africa and the Democratic Republic
of the Congo, to monitoring and investigating disease outbreaks in the
U.S., to pandemic flu preparedness to combating antimicrobial
resistance, CDC is the nation's--and the world's--expert resource and
response center, coordinating communications and action and serving as
the laboratory reference center for identifying, testing and
characterizing potential agents of biological, chemical and
radiological terrorism, emerging infectious diseases and other public
health emergencies.
We strongly support the president's budget request for $400 million
in new funding to bolster core public health infrastructure and
capacity at the federal, state, territorial and local levels. This
flexible funding is critical to addressing the gaps in core public
health infrastructure and capacity at all levels as well as ensuring
our nation's health departments are able to attract and retain
experienced leaders and respond to future public health emergencies and
disease outbreaks. Sustained, flexible funding is critical to
rebuilding and strengthening the nation's public health system.
CDC serves as the lead agency for bioterrorism and other public
health emergency preparedness and response programs. We urge you to
provide adequate funding for the Public Health Emergency Preparedness
grants which provide resources to our state and local health
departments to help them protect communities during public health
emergencies. We also urge you to provide adequate funding for CDC's
infectious disease, laboratory and disease detection capabilities to
ensure we are prepared to tackle both ongoing COVID-19 pandemic and
other public health challenges and emergencies that will likely arise
during the coming fiscal year. Your continued support for CDC's public
health Data Modernization Initiative is critical to ensuring we have
both the world-class data workforce and data systems that are ready for
the next public health emergency.
We thank Congress for providing CDC with dedicated funding for
firearm morbidity and mortality prevention research in FY 2020 and FY
2021 and we strongly urge you to increase this funding in FY 2022 to
$50 million for CDC and NIH, as requested in President Biden's FY 2022
discretionary budget proposal. This will allow CDC to conduct research
into important issues including the best ways to prevent unintended
firearm injuries and fatalities among women and children; the most
effective methods to prevent firearm-related suicides; and the measures
that can best prevent the next shooting at a school or public place.
CDC's National Center for Environmental Health works to control
asthma, protect against threats associated with natural disasters and
climate change, reduce and monitor exposure to lead and other
environmental health hazards and ensure access to safe and clean water.
We urge you to provide at least $322 million for NCEH in FY 2022,
including $110 million for CDC's Climate and Health program, as
requested in President Biden's FY 2022 discretionary budget request.
Climate change is threating our health in many ways through the
increased spread of vector-borne diseases, degraded air quality from
ozone pollution and wildfire smoke, hotter temperatures and more
extreme weather events. Increased funding will allow CDC to provide
funding to all 50 states and to support additional, cities, counties
and tribes to help them prepare for and respond to the health impacts
of climate change in their communities.
Programs under the National Center for Chronic Disease Prevention
and Health Promotion address heart disease, stroke, cancer, diabetes
and tobacco use that are the leading causes of death and disability in
the U.S. and are also among the costliest to our health system. CDC
provides funding for state programs to prevent disease, conduct
surveillance to collect data on disease prevalence, monitor
intervention efforts and translate scientific findings into public
health practice in our communities. We strongly urge increased
investments in these critical programs that are essential to reducing
death, disability and health care costs. In particular, we urge your
support for the president's request of $153 million for CDC's Social
Determinants of Health Program. This increased funding would allow CDC
to provide public health departments, academic institutions and
nonprofit organizations funding and tools to support cross sector
efforts to address the impact that social determinants of health such
as unsafe and unstable housing, income insecurity, lack of
transportation, and underlying health inequities have on the health of
their communities.
Health Resources and Services Administration: HRSA is the primary
federal agency dedicated to improving health outcomes and achieving
health equity. HRSA's 90-plus programs and more than 3,000 grantees
support tens of millions of geographically isolated, economically or
medically vulnerable people, in every U.S. state and territory, to
achieve improved health outcomes by increasing access to quality health
care and services; fostering a health care workforce able to address
current and emerging needs; enhance population health and address
health disparities through community partnerships; and promote
transparency and accountability within the health care system.
We are grateful for the increases provided for HRSA programs in FY
2021 and for the emergency supplemental funding to battle the COVID-19
pandemic, but HRSA's discretionary budget authority is far too low to
effectively address the nation's current public health and health care
needs. We recommend Congress build upon the important increases they
provided HRSA in FY21 and provide at least $9.2 billion for the Health
Resources and Services Administration in FY 2022
HRSA programs and grantees are providing innovative and successful
solutions to some of the nation's greatest health care challenges
including the rise in maternal mortality, the severe shortage of health
professionals, the high cost of health care and behavioral health
issues related to substance use disorders-including opioid misuse.
Additional funding will allow HRSA build upon these successes and pave
the way for new achievements by supporting critical HRSA programs,
including:
Primary Health Care that supports nearly 13,000 health center sites
in medically underserved communities across the U.S., providing access
to high-quality preventive and primary care to nearly 30 million people
including 1 in 3 people living in poverty.
Health Workforce supports the health workforce across the training
continuum and offers scholarship and loan repayment programs to ensure
a well-prepared, well-distributed and diverse workforce that is ready
to meet the current and evolving health care needs of the nation.
Maternal and Child Health supports initiatives that reduce infant
mortality, minimize disparities, prevent chronic conditions and improve
access to quality health care for vulnerable women, infants and
children; and serves 60 million people through the MCH block grant.
HIV/AIDS programs deliver a comprehensive system of care to more
than 519,000 individuals impacted by HIV/AIDS, improving health
outcomes for people with HIV and reducing the chance of others becoming
infected, and provides training for HIV/AIDS health professionals.
HRSA's Ryan White HIV/AIDS Program effectively engages clients in
comprehensive care and treatment, including increasing access to HIV
medication, which has resulted in 88.1% of clients achieving viral
suppression, compared to just 64.7% of all people living with HIV
nationwide.
Family Planning Title X services ensure access to comprehensive
family planning and preventive health services for over 3.1 million
people, reducing unintended pregnancy rates, limiting sexually
transmitted infection transmission and increasing early detection of
cancers.
Rural Health supports community solutions to improve efficiencies
in delivering rural health services and expand access, including
supporting activities that aim to increase access to opioid treatment
in rural areas and promote the use of health information technology and
telehealth.
HRSA has also been active in the COVID-19 pandemic response,
awarding billions of dollars to health centers to administer COVID-19
tests and reimbursing providers who offer COVID-19 care to uninsured
individuals.
In closing, we emphasize that the public health system requires
stronger financial investments at every stage. It is critical that
Congress increase its investments in CDC and HRSA programs to enable
the nation to meet the mounting health challenges we currently face and
to become a healthier nation.
[This statement was submitted by Georges C. Benjamin, MD, Executive
Director, American Public Health Association.]
______
Prepared Statement of the American Society for Engineering Education
This written testimony is submitted on behalf of the American
Society for Engineering Education (ASEE) to the Senate Subcommittee on
Labor, Health and Human Services, Education, and Related Agencies for
the official record. ASEE appreciates the Committee's support for the
Department of Education (ED) in fiscal year (FY) 2021 and asks you to
robustly fund student aid, teacher preparation, and STEM programs in FY
2022. Additionally, ASEE requests federal funding to support
initiatives aimed at increasing the diversity of the STEM pipeline and
support for Minority-Serving Institutions (MSIs). The strong support of
the National Institutes of Health (NIH) in FY 2021 was greatly
appreciated and ASEE requests continued support of NIH.
The American Society for Engineering Education (ASEE) advances
innovation, excellence, and access at all levels of education for the
engineering profession and is the only society representing the
country's schools and colleges of engineering and engineering
technology. Membership includes over 12,000 individuals hailing from
all disciplines of engineering and engineering technology including
educators, researchers, and students as well as industry and government
representatives. As the pre-eminent authority on the education of
engineering professionals, ASEE seeks to advance the development of
innovative approaches and solutions to engineering education and
advocates for equal access to engineering educational opportunities for
all.
Student Aid
Student aid programs like Pell Grants, Federal Work-Study (FWS),
TRIO, and others make higher education accessible and affordable for
millions of students. We appreciate the commitment the Biden
Administration has made to affordable education through its preliminary
Presidential Budget Request and the American Families Plan. ASEE joins
the higher education community in requesting funding to support
doubling the maximum Pell Grant award to $12,990. Pell Grants are
essential to low-income students being able to afford higher education.
These awards are vital in helping students access the significant life
and career benefits that higher education provides. These benefits are
especially prevalent for engineering education, which provides a proven
pathway to the middle class, especially for students from low-income
backgrounds. ASEE requests funding for Federal Work Study (FWS) at
$1.480 billion and $1.061 billion for Supplemental Educational
Opportunity Grant (SEOG). These programs are need-based, and often this
aid provides the resources a student needs to complete their education.
ASEE asks the Committee to consider ways to support work-based
learning, such as co-operative education and apprenticeships, within
the FWS program. ASEE firmly believes in ensuring access to engineering
and engineering technology education for all students, not just those
who can afford it, which is why ensuring student aid programs for
graduate students is also very important. ASEE requests funding for the
Graduate Assistance in Areas of National Need (GAANN) program, which
provides fellowships, through academic departments and programs of
institutions of higher education, to assist graduate students with
excellent records who demonstrate financial need. ASEE requests $35
million for GAANN.
Teacher Preparation
The need for well-prepared and content-confident teachers in early
childhood, elementary, and secondary education is high, particularly in
STEM subjects. The lack of teacher training focused on STEM, and
engineering in particular, is an important issue facing K-12 education.
Problem-based learning that incorporates engineering design and
analysis skills are often absent from teacher preparation and
professional development programs. ASEE supports vigorous funding for
Title II of the Elementary and Secondary Education Act (ESEA), which
supports the preparation and professional development of school
personnel, and Title II of the Higher Education Act, which supports
teacher preparation programs at institutions of higher education. ASEE
also supports President Biden's proposal to invest $9 billion in
training and diversifying the teaching workforce presented in the
American Families Plan. Efforts to support teaching skills for STEM
postsecondary faculty should also be considered and could include
partnerships between STEM disciplines and Schools of Education to
support STEM faculty and support for teaching and learning centers at
postsecondary institutions. Support of postsecondary faculty and their
promotion of STEM learning should utilize research-based methods. Our
future is dependent on today's students finding solutions to tomorrow's
problems. This can only be accomplished if those students have teachers
who are prepared to guide them in developing the knowledge and skills
needed to solve those problems.
STEM
Support for science, technology, engineering, and mathematics
(STEM) continues to grow and ASEE appreciates the support many STEM
programs received in FY 2021. ASEE supports funding for Title IV of the
Elementary and Secondary Education Act (ESEA) at its authorized amount
of $1.6 billion, which will allow states and school districts
additional resources to pursue STEM programs. ASEE supports robust
funding for STEM programs for higher education students including the
Hispanic-Serving Institutions (HSI) STEM and Minority Science and
Engineering Improvement (MSEIP) programs. The STEM workforce is a
driving force behind innovation and our economic development. These and
other programs targeted towards increasing the representation of
historically underrepresented populations, including women, will ensure
a healthy STEM workforce pipeline.
Career and Technical Education (CTE)
ASEE knows that high-quality Career and Technical Education (CTE)
prepares students for careers and further postsecondary education while
fulfilling employer needs in high-demand sectors of the economy.\1\
ASEE supports CTE and wants to ensure best practices and high-quality
programs are embedded in its programs, for example through faculty
professional development and connections to the National Science
Foundation -supported Advanced Technological Education (ATE) programs.
ASEE also wants to strengthen pathways between CTE at the associate
degree level to 4-year engineering technology and engineering degrees.
ASEE believes that students should have lifelong options for continuing
study and career advancement and that CTE programs can help students
achieve their goals. In order for states and their CTE educators to
provide high-quality CTE opportunities for students and strengthen
pathways between two- and four-year institutions of higher education,
ASEE urges Congress to robustly fund the Perkins Basic State Grant
funding program in FY 2022 and encourage the program to build
connections with NSF's ATE program.
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\1\ https://www.acteonline.org/wp-content/uploads/2021/04/
2021_ACTE_Legislative_Priorities
_April.pdf.
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National Institutes of Health--National Institute of Biomedical Imaging
and Bioengineering (NIBIB)
NIBIB is the major NIH Institute focused on engineering
applications to human health and training the next generation of
biomedical engineers. ASEE is grateful to the committee for its strong
bipartisan support of the NIH in FY 2021. NIBIB funding is critical for
the development of devices and tools that can improve the detection,
treatment, and prevention of disease, and also plays a critical role in
assessing the effectiveness of new drugs and treatment procedures.
NIBIB also supports training programs to enhance and expand education
and training for the next generation biomedical engineering workforce.
Through grant programs like the Enhancing Science, Technology, and Math
Education Diversity Research Education Experiences, and Team-Based
Design in Biomedical Engineering Education, NIBIB is committed to
supporting all stages of the biomedical engineering career pathway and
increasing the participation of traditionally underrepresented groups
in engineering. ASEE urges the Committee to provide NIH with $46.1
billion in FY 2022 so that NIBIB can continue to support critical
biomedical engineering research and training.
conclusion
Engineering and engineering technology academic programs play
critical roles in the STEM ecosystem. The requests made here support
the development of a skilled technical workforce, broadening
participation, and transdisciplinary study. Thank you for the
opportunity to submit this testimony.
[This statement was submitted by Sheryl Sorby, Ph.D., President,
and Norman Fortenberry, Sc.D., Executive Director, American Society for
Engineering
Education.]
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