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Nominations of Andrea Joan Palm and Chiquita Brooks-LaSure — Senate Finance Committee Hearing (April 15, 2021)

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Printed record of the hearing of the Committee on Finance, United States Senate, on April 15, 2021, on the nominations of Andrea Joan Palm to be Deputy Secretary of Health and Human Services and Chiquita Brooks-LaSure to be CMS Administrator. Chairman Ron Wyden calls both nominees highly qualified and names priorities including updating the Medicare guarantee, mental health services, health-care disparities and prescription drug costs. Ranking member Mike Crapo stresses innovation, concern over how some health policies would be enacted and paid for, and drug pricing. Senators Baldwin and Menendez introduce the nominees. A letter from health-law advocates urging confirmation of Brooks-LaSure is also reproduced.

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Congressional materials
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61 Medicaid Fmapp Nominations Of Andrea Joan Palm And Chiquita Brooks Lasure
Case
61 Medicaid Fmapp Nominations Of Andrea Joan Palm And Chiquita Brooks Lasure

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“Nominations of Andrea Joan Palm and Chiquita Brooks-LaSure — Senate Finance Committee Hearing (April 15, 2021).” Original at www.govinfo.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/61-medicaid-fmapp-nominations-of-andrea-joan-palm-and-chiquita-brooks-lasure/, SHA-256 5efecfece7a1353ff3f6d67805f48ad43a75dac64c9787a060e7640635e8c9a8.

Full text

                                                                                                                      S. HRG. 117–341

                                                 NOMINATIONS OF ANDREA JOAN PALM
                                                    AND CHIQUITA BROOKS-LaSURE


                                                                          HEARING
                                                                                  BEFORE THE


                                                          COMMITTEE ON FINANCE
                                                          UNITED STATES SENATE
                                                    ONE HUNDRED SEVENTEENTH CONGRESS
                                                                                FIRST SESSION

                                                                                     ON THE

                                                                               NOMINATIONS OF

                                      ANDREA JOAN PALM, TO BE DEPUTY SECRETARY, DEPARTMENT OF
                                       HEALTH AND HUMAN SERVICES; AND CHIQUITA BROOKS-LaSURE, TO
                                       BE ADMINISTRATOR, CENTERS FOR MEDICARE AND MEDICAID SERV-
                                       ICES


                                                                                APRIL 15, 2021




                                                                                    (

                                                          Printed for the use of the Committee on Finance


                                                                   U.S. GOVERNMENT PUBLISHING OFFICE
                                           48–327—PDF                          WASHINGTON : 2022




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                                                                       COMMITTEE ON FINANCE
                                                               RON WYDEN, Oregon, Chairman
                                      DEBBIE STABENOW, Michigan             MIKE CRAPO, Idaho
                                      MARIA CANTWELL, Washington            CHUCK GRASSLEY, Iowa
                                      ROBERT MENENDEZ, New Jersey           JOHN CORNYN, Texas
                                      THOMAS R. CARPER, Delaware            JOHN THUNE, South Dakota
                                      BENJAMIN L. CARDIN, Maryland          RICHARD BURR, North Carolina
                                      SHERROD BROWN, Ohio                   ROB PORTMAN, Ohio
                                      MICHAEL F. BENNET, Colorado           PATRICK J. TOOMEY, Pennsylvania
                                      ROBERT P. CASEY, JR., Pennsylvania    TIM SCOTT, South Carolina
                                      MARK R. WARNER, Virginia              BILL CASSIDY, Louisiana
                                      SHELDON WHITEHOUSE, Rhode Island      JAMES LANKFORD, Oklahoma
                                      MAGGIE HASSAN, New Hampshire          STEVE DAINES, Montana
                                      CATHERINE CORTEZ MASTO, Nevada        TODD YOUNG, Indiana
                                      ELIZABETH WARREN, Massachusetts       BEN SASSE, Nebraska
                                                                            JOHN BARRASSO, Wyoming


                                                                      JOSHUA SHEINKMAN, Staff Director
                                                                   GREGG RICHARD, Republican Staff Director

                                                                                      (II)




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                                                                                      CONTENTS

                                                                                   OPENING STATEMENTS
                                                                                                                                                                     Page
                                      Wyden, Hon. Ron, a U.S. Senator from Oregon, chairman, Committee on
                                        Finance ..................................................................................................................     1
                                      Crapo, Hon. Mike, a U.S. Senator from Idaho ......................................................                               3
                                      Menendez, Hon. Robert, a U.S. Senator from New Jersey ...................................                                        6

                                                                                CONGRESSIONAL WITNESS
                                      Baldwin, Hon. Tammy, a U.S. Senator from Wisconsin .......................................                                       5

                                                                              ADMINISTRATION NOMINEES
                                      Palm, Andrea Joan, nominated to be Deputy Secretary, Department of Health
                                        and Human Services, Washington, DC ..............................................................                              7
                                      Brooks-LaSure, Chiquita, nominated to be Administrator, Centers for Medi-
                                        care and Medicaid Services, Department of Health and Human Services,
                                        Washington, DC ...................................................................................................             9

                                                          ALPHABETICAL LISTING AND APPENDIX MATERIAL
                                      Baldwin, Hon. Tammy:
                                          Testimony ..........................................................................................................         5
                                      Brooks-LaSure, Chiquita:
                                          Testimony ..........................................................................................................         9
                                          Prepared statement ..........................................................................................               49
                                          Biographical information .................................................................................                  50
                                          Responses to questions from committee members .........................................                                     59
                                      Crapo, Hon. Mike:
                                          Opening statement ...........................................................................................                3
                                          Prepared statement ..........................................................................................              103
                                      Menendez, Hon. Robert:
                                          Opening statement ...........................................................................................                6
                                      Palm, Andrea Joan:
                                          Testimony ..........................................................................................................         7
                                          Prepared statement ..........................................................................................              104
                                          Biographical information .................................................................................                 105
                                          Responses to questions from committee members .........................................                                    113
                                      Wyden, Hon. Ron:
                                          Opening statement ...........................................................................................                1
                                          Prepared statement with attachments ...........................................................                            137

                                                                                                     (III)




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                                         NOMINATIONS OF ANDREA JOAN PALM,
                                      TO BE DEPUTY SECRETARY, DEPARTMENT OF
                                          HEALTH AND HUMAN SERVICES; AND
                                           CHIQUITA BROOKS-LaSURE, TO BE
                                       ADMINISTRATOR, CENTERS FOR MEDICARE
                                               AND MEDICAID SERVICES

                                                                   THURSDAY, APRIL 15, 2021

                                                                                  U.S. SENATE,
                                                                           COMMITTEE ON FINANCE,
                                                                                        Washington, DC.
                                        The hearing was convened, pursuant to notice, at 9:30 a.m., via
                                      Webex, in the Dirksen Senate Office Building, Hon. Ron Wyden
                                      (chairman of the committee) presiding.
                                        Present: Senators Stabenow, Cantwell, Menendez, Carper,
                                      Cardin, Brown, Bennet, Casey, Warner, Whitehouse, Hassan, Cor-
                                      tez Masto, Warren, Crapo, Grassley, Cornyn, Thune, Cassidy, and
                                      Daines.
                                        Also present: Democratic staff: Michael Evans, Deputy Staff Di-
                                      rector and Chief Counsel; Ian Nicholson, Investigative and Nomi-
                                      nations Advisor; and Joshua Sheinkman, Staff Director. Republican
                                      staff: Kellie McConnell, Health Policy Director; and Gregg Richard,
                                      Staff Director.
                                       OPENING STATEMENT OF HON. RON WYDEN, A U.S. SENATOR
                                         FROM OREGON, CHAIRMAN, COMMITTEE ON FINANCE
                                         The CHAIRMAN. The Finance Committee will come to order.
                                      Today, the committee meets to discuss two important health-care
                                      nominations. Chiquita Brooks-LaSure has been nominated to serve
                                      as Administrator for the Centers for Medicare and Medicaid Serv-
                                      ices, and Andrea Palm is nominated to serve as Deputy Secretary
                                      of the Department of Health and Human Services.
                                         Ms. Brooks-LaSure has served at OMB, on the staff at Ways and
                                      Means, at the Department of Health and Human Services, and she
                                      has worked in the private sector. She helped craft policies bringing
                                      down costs for older people. She helped to develop and pass key
                                      portions of the Affordable Care Act. She helped implement the law,
                                      and she worked hard to make sure that middle-class families shop-
                                      ping for private health options would get a fair shake thanks to
                                      strong consumer protections.
                                         Now, the Trump administration later undermined a lot of those
                                      protections, and that has created a host of new challenges for the
                                      committee and for the Biden administration.
                                                                                          (1)




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                                         Ms. Brooks-LaSure is also very well-versed in Medicaid policy,
                                      which is a hugely important part of this committee’s responsibility.
                                      She has worked closely with the Federal Government, States, and
                                      private organizations to expand coverage.
                                         Continuing on the theme of impeccable qualifications and experi-
                                      ence, Ms. Palm is a proven health-care agency leader who knows
                                      what it takes to run HHS in a smooth way. She previously served
                                      as the Department’s Chief of Staff and Senior Counselor to the Sec-
                                      retary during the Obama administration. Most recently, she served
                                      as Secretary-Designee of the Wisconsin Department of Health Serv-
                                      ices, a $12-billion agency. She has been the point person when it
                                      comes to COVID response in the State of Wisconsin. There she led
                                      efforts to expand insurance coverage, improve mental health care,
                                      and reduce hunger.
                                         My bottom line: these are two individuals who are extraor-
                                      dinarily qualified for these essential positions and would be ready
                                      to go on Day 1 after they are confirmed by the Senate. There is
                                      a lot of work to be done at HHS; vaccinations are way up, but cases
                                      and deaths are still awfully high. Long, long way to go on the pan-
                                      demic.
                                         Now, the committee is also going to keep working on other im-
                                      portant health challenges, which I and other members have dis-
                                      cussed with our nominees. For example, I have said that every sin-
                                      gle time this committee talks about Federal health programs, we
                                      are going to be talking about updating the guarantee of Medicare.
                                      When I was coming up with the Gray Panthers, Medicare was an
                                      acute-care program. If you broke your ankle, it was Part A, or if
                                      you had a horrible case of the flu, then you went to the doctor or
                                      hospital for the broken ankle. Today, Medicare is cancer and diabe-
                                      tes and heart disease and strokes, and so many older Americans
                                      have two or more of these conditions.
                                         So this committee led the bipartisan passage of the CHRONIC
                                      Care Act in 2017. The Trump administration slow-walked the im-
                                      plementation. So I am looking forward to working with both of our
                                      nominees to turn this situation around.
                                         Second, the American Rescue Plan made a big down payment on
                                      mental health services. Senator Stabenow has worked tirelessly on
                                      this issue. And I was very pleased that now in the Medicaid pro-
                                      gram, for several years, we will have the CAHOOTS program,
                                      which is a fresh and exciting model so that mental health profes-
                                      sionals and law enforcement professionals are teaming up to deal
                                      with the tragedies we see on our streets that so often involve men-
                                      tal health needs. I am very proud that Oregon has been a pioneer,
                                      and I gather, based on reports, that the Oregon program, their
                                      phones are ringing off the hook from around the country, from com-
                                      munities that want to copy what we have done.
                                         A special priority for us on the Finance Committee is dealing
                                      with the issue of inequality in Federal health programs. We saw
                                      once again, during the pandemic, the results of health-care dispari-
                                      ties up close. Blacks, Latinos and Native Americans have suffered
                                      and died from COVID–19 at much higher rates. Now, it is not just
                                      about COVID–19; it is about maternal health, because women
                                      today are more likely to die in childbirth than their mothers were
                                      a generation ago.




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                                        It is outrageous, I say to our nominees and colleagues, that in
                                      affluent white suburbs there are all kinds of health-care services
                                      of the most sophisticated nature, and in so many communities of
                                      color, it is like a health-care desert, and this committee is deter-
                                      mined to change that.
                                        Finally, we will be working closely with all of you on the issue
                                      of lowering prescription drug costs. A lot of Americans feel they are
                                      just getting mugged when they go to the pharmacy counter, and we
                                      have concrete ideas for doing something about it.
                                        In addition to the CAHOOTS program, there will be other men-
                                      tal health issues. I am very troubled about the fact that the parity
                                      law, which is supposed to give mental health and physical health
                                      the same treatment, seems to be honored too often in the breach
                                      rather than in the observance. We will talk to you about that as
                                      well.
                                        I want to thank both of you for being willing to do another stint
                                      in public service. We will hear from Senator Crapo, our ranking
                                      member, also from the Pacific Northwest, and then we have our
                                      colleagues here to introduce our nominees.
                                        Senator Crapo?
                                        [The prepared statement of Chairman Wyden appears in the ap-
                                      pendix.]
                                                    OPENING STATEMENT OF HON. MIKE CRAPO,
                                                          A U.S. SENATOR FROM IDAHO
                                         Senator CRAPO. Thank you, Mr. Chairman.
                                         When we held our hearing for Xavier Becerra to be Secretary of
                                      Health and Human Services, I noted the size and importance of the
                                      department he would lead.
                                         In normal times, HHS and its agencies provide health-care serv-
                                      ice to nearly 150 million people, and those agencies affect the lives
                                      of many, many more on a daily basis. The COVID–19 pandemic has
                                      raised the salience of the Department. The Department’s leader-
                                      ship, including the Deputy Secretary, will continue to play a key
                                      role in bringing us out of this public health emergency.
                                         Similarly, Medicare and Medicaid are providing essential health
                                      care to patients who have suffered disproportionately from the
                                      COVID–19 pandemic. Looking to the future, the Secretary, the
                                      Deputy Secretary, and the CMS Administrator must carefully
                                      evaluate how best to use resources available to them to promote
                                      the health of our citizens. They must do so carefully, constructively,
                                      and creatively.
                                         Two months ago, I outlined several issues in the health-care
                                      space where I intend to focus my efforts as ranking member, in-
                                      cluding fostering innovation to improve patient care and make our
                                      health-care system more efficient. The COVID–19 pandemic has
                                      threatened Americans’ physical and economic health, but it has
                                      also reinforced the value of innovation and provided an opportunity
                                      to test changes that foster it.
                                         HHS has used this authority under the public health emergency
                                      to waive numerous requirements to ensure Medicare and Medicaid
                                      beneficiaries and other patients receive care during the pandemic.
                                      Patients and providers have benefited from expanded access to
                                      telehealth and expedited approval of COVID–19 vaccines, diag-




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                                      nostics, and treatments. Going forward, Medicare and Medicaid pa-
                                      tients must have the same access to those innovative items and
                                      services as those with commercial insurance.
                                         We must carefully evaluate our response to the pandemic and
                                      implement appropriate reforms based on the lessons we have
                                      learned. HHS should partner with this committee in that effort.
                                         However, media reports about certain health-care policies that
                                      may come before Congress, or be enacted through executive actions,
                                      are concerning to me. Some of these policies, such as including ad-
                                      ditional benefits under Medicare, could experience bipartisan sup-
                                      port if considered through a transparent, cooperative, bipartisan
                                      process. Unfortunately, reconciliation does not afford Congress the
                                      opportunity to work together to evaluate these changes and make
                                      necessary reforms to protect the long-term financial viability of the
                                      program.
                                         Other policies, such as expanding Obamacare’s premium subsidy
                                      to everyone, regardless of income, would be incredibly expensive for
                                      taxpayers without taking appropriate steps to lower the cost of
                                      health insurance.
                                         Creative, bipartisan ideas to lower the cost of insurance in the
                                      individual market have been raised by States and my colleagues in
                                      this committee. I welcome the opportunity to work together on
                                      these ideas, such as allowing States to use waivers to their full po-
                                      tential, diversifying benefit designs and incentivizing competition.
                                         Finally, I am concerned about paying for some of these policies
                                      through changes in our drug pricing system that could stifle inno-
                                      vation. We can see the end of the COVID–19 pandemic approach-
                                      ing, thanks to groundbreaking vaccines developed by pharma-
                                      ceutical manufacturers. In this crisis, industry responded to the
                                      Nation’s call to arms, code-named Project Warp Speed, developing
                                      powerful and effective vaccines in record time.
                                         This success was possible because of the private sector. I strongly
                                      agree with my colleagues that this innovation is only valuable if
                                      patients can afford it. We should establish an out-of-pocket spend-
                                      ing cap and reform Medicare Part D with the market-based prin-
                                      ciples of competition and transparency in mind.
                                         Ms. Palm and Ms. Brooks-LaSure, if you are confirmed, I look
                                      forward to working with you to improve our health-care system. I
                                      ask you to commit to careful assessments of the risks and consider-
                                      ations in every policy decision you make.
                                         Political pressures possibly make unilateral actions seem attrac-
                                      tive, but you should also consider how the market, individual
                                      choice, public policy, and incentives play vital roles in development
                                      and delivery of health care.
                                         I look forward to hearing your testimony and your responses to
                                      questions.
                                         These positions to which you have been nominated have substan-
                                      tial influence over policy. The members of this committee need to
                                      understand how you will implement the administration’s agenda.
                                      And we expect your answers here and in response to the QFRs to
                                      be detailed and candid.
                                         I look forward to the opportunity to visit with you today.
                                         Thank you, Mr. Chairman.




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                                        [The prepared statement of Senator Crapo appears in the appen-
                                      dix.]
                                        The CHAIRMAN. Thank you, Senator Crapo.
                                        Our nominees have the good fortune of being introduced by two
                                      Senators with a long history of health-care advocacy, and we will
                                      start with Senator Baldwin, who will introduce Ms. Palm; then we
                                      will go with Senator Menendez, who will introduce Ms. Brooks-
                                      LaSure.
                                        Senator Baldwin?
                                                         STATEMENT OF HON. TAMMY BALDWIN,
                                                           A U.S. SENATOR FROM WISCONSIN
                                        Senator BALDWIN. Thank you, Chairman Wyden and Ranking
                                      Member Crapo, for holding this hearing, and I am honored to be
                                      here today to introduce Andrea Palm, President Biden’s nominee
                                      for Deputy Secretary of Health and Human Services.
                                        More than 2 years ago, Governor Tony Evers selected Andrea
                                      Palm to serve as Secretary of the Wisconsin Department of Health
                                      Services. I met with her very soon after that announcement and
                                      was immediately struck with her expert understanding of the
                                      health policy landscape, as well as her keen interest in building re-
                                      lationships with stakeholders from across our State.
                                        Her prior experience, as a Senior Counselor to HHS Secretary
                                      Burwell and as a Senior Advisor on the White House Domestic Pol-
                                      icy Council, provided her with strong qualifications to serve our
                                      State. With this foundation of experience, Andrea Palm delivered
                                      leadership to Wisconsin during the COVID–19 pandemic, and she
                                      built an effective response to the public health crisis we faced in
                                      our State, including her efforts to build a testing, contact tracing,
                                      and vaccination infrastructure in the State of Wisconsin.
                                        Andrea’s nomination as Wisconsin DHS Secretary, like other
                                      nominations from our Governor, was politicized from the beginning
                                      by the Republican-controlled Wisconsin State legislature. It is true
                                      they held up her nomination for months during an unprecedented
                                      global health crisis. It is also true that the State legislature refused
                                      to convene for more than 9 months, and instead sought to limit the
                                      power of the Governor and other public health leaders even as Wis-
                                      consin was experiencing one of the worst COVID–19 outbreaks in
                                      the country.
                                        Despite these barriers, Andrea Palm led and put the people of
                                      Wisconsin ahead of State capital politics. In the face of consistent
                                      and constant political bickering and obstruction, Andrea Palm
                                      stayed the course and lived up to our State motto: ‘‘Forward.’’ She
                                      made every possible effort to collaborate with stakeholders and
                                      trusted messengers throughout the State to protect Wisconsinites
                                      and provide them with the information needed to protect them-
                                      selves and their families. And most importantly, Andrea provided
                                      leadership in Wisconsin that was always focused on science, public
                                      health, and the idea that we are all in this together.
                                        Because of Andrea’s leadership, Wisconsin has maintained one of
                                      the fastest vaccination rates in the country. She set us up for suc-
                                      cess in Wisconsin as a national leader in getting people vaccinated
                                      quickly, and I give her a tremendous amount of credit for where
                                      we today, because she helped put the partnerships in place that we




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                                      have used to get shots in people’s arms and to protect public
                                      health.
                                         She also worked to ensure robust data transparency since the
                                      very beginning of the pandemic, which continues to inform our vac-
                                      cine roll-out and help us reach underserved communities. And in
                                      rural areas of Wisconsin, residents are getting vaccinated as quick-
                                      ly and as easily as residents in urban areas, a direct result of her
                                      focus on building relationships with stakeholders across our State.
                                         Having Andrea back at HHS will be a tremendous benefit for the
                                      Department and all of our States, because she understands the ur-
                                      gent need to beat this pandemic and ensure the health and safety
                                      of all Americans.
                                         Andrea, welcome back to the Senate, and thank you for your
                                      service to the State of Wisconsin. Your hard work has always en-
                                      abled you to meet and overcome challenges, and I look forward to
                                      seeing you confirmed as Deputy Secretary of Health and Human
                                      Services.
                                         The CHAIRMAN. Senior Baldwin, thank you, and you are always
                                      welcome in this committee.
                                         Senator Menendez?
                                              OPENING STATEMENT OF HON. ROBERT MENENDEZ,
                                                    A U.S. SENATOR FROM NEW JERSEY
                                         Senator MENENDEZ. Well, thank you, Mr. Chairman. And there
                                      are many reasons we want to finally beat this pandemic: the health
                                      and welfare of our families, our neighbors, and our fellow Ameri-
                                      cans. And because, after 16 years, I had finally worked my way
                                      down this dais close to Senator Stabenow, I am hoping that we can
                                      get to that point—that we can get there again.
                                         Mr. Chairman, Ranking Member Crapo, and fellow members of
                                      the Senate Finance Committee, today I have the pleasure of intro-
                                      ducing you to Ms. Chiquita Brooks-LaSure, President Biden’s nomi-
                                      nee to lead the Center for Medicare and Medicaid Services. And I
                                      must admit, I was thrilled to learn of Ms. Brooks-LaSure’s nomina-
                                      tion to serve as CMS Administrator.
                                         A native of Willingboro, NJ, Ms. Brooks-LaSure graduated from
                                      Princeton University, earned a master’s in public policy from
                                      Georgetown, and embarked on an impressive career in Federal
                                      health policy.
                                         To say Ms. Brooks-LaSure understands the U.S. health-care sys-
                                      tem would be an understatement. Over the course of more than 2
                                      decades, she has amassed a deep working knowledge of Federal
                                      health-care policy and the vital role that programs like Medicare,
                                      Medicaid, and the Affordable Care Act play in the lives of patients
                                      and consumers, especially those who are from low-income commu-
                                      nities and communities of color.
                                         CMS is sure to benefit from Ms. Brooks-LaSure’s extensive expe-
                                      rience, from her early days coordinating Medicaid policy in the Of-
                                      fice of Management and Budget; to her work with the House Ways
                                      and Means Committee, passing signature legislation like the Af-
                                      fordable Care Act; to her service as Director of Coverage Policy at
                                      the Department of Health and Human Services; as well as deputy
                                      director for policy at the Center for Consumer Information and In-
                                      surance Oversight.




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                                        Most recently in the private sector, Ms. Brooks-LaSure worked at
                                      the firm of Manatt, Phelps, and Phillips, helping clients in the
                                      health-care space navigate regulatory issues often involving Med-
                                      icaid and Medicare.
                                        Simply put, her credentials are impeccable. And her commitment
                                      to building a more equitable and accessible health-care system is
                                      unshakable. If confirmed, Ms. Brooks-LaSure will be the first
                                      African-American woman ever to serve as CMS Administrator, and
                                      her historic nomination comes at a historic moment for our coun-
                                      try.
                                        The COVID–19 pandemic has exposed and aggravated the long-
                                      standing racial inequalities and inequities in our country, that
                                      even in good times, leave people of color more vulnerable to poor
                                      access, financial hardship, disease, and death. As we emerge from
                                      this crisis, I can think of no one better positioned or more com-
                                      mitted to rooting out the disparities in our health-care system than
                                      today’s nominee, Ms. Brooks-LaSure.
                                        And I know my colleague from New Jersey, Senator Booker,
                                      asked as well to join in our enthusiasm for her historic nomination.
                                        Thank you, Mr. Chairman.
                                        The CHAIRMAN. I thank our colleague, and our colleague has
                                      been heavily involved on health-care issues here today, so we are
                                      glad to hear his ringing support for the nominee.
                                        I am also at this point going to introduce a letter of support, and
                                      a statement for the record.
                                        Without objection, I will make these a part of today’s hearing
                                      record.
                                        [The letter and statement appear in the appendix beginning on
                                      p. 138.]
                                        The CHAIRMAN. We will now have opening statements for Ms.
                                      Palm and Ms. Brooks-LaSure, and then we have some formalities
                                      we have to deal with. I thank our colleagues for being here.
                                        Ms. Palm?

                                      STATEMENT OF ANDREA JOAN PALM, NOMINATED TO BE DEP-
                                       UTY SECRETARY, DEPARTMENT OF HEALTH AND HUMAN
                                       SERVICES, WASHINGTON, DC
                                         Ms. PALM. Thank you, Chairman Wyden, Ranking Member
                                      Crapo. Good to see you both this morning. I’m grateful for the op-
                                      portunity to testify before you today as President Biden’s nominee
                                      for Deputy Secretary of the United States Department of Health
                                      and Human Services.
                                         I want to thank Senator Tammy Baldwin for the kind introduc-
                                      tion and for her work on behalf of the people of Wisconsin. I’d also
                                      like to acknowledge and thank my husband Dan, who is here with
                                      me today. And thank you to the members of this committee for con-
                                      sidering my nomination. I have enjoyed the opportunity to speak
                                      with many of you individually throughout this process.
                                         I was born and raised in Star Lake, NY, a town of about 1,000
                                      people. When you grow up in a small town, you understand from
                                      a young age that together is the only way to get things done. That
                                      sense of community was formative and is what led me to become
                                      a social worker. I spent my twenties as a caseworker, finding safe




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                                      homes for children in crisis and working with people in behavioral
                                      health crises.
                                         These experiences shaped the rest of my career. It was the chil-
                                      dren and families I worked with during this time that made me
                                      want to change the system, and drew me to public service and to
                                      public policy. The memories of these kids are what still motivates
                                      me today.
                                         I have spent my entire career focused on health and human serv-
                                      ices policy and lifting our most vulnerable communities, from my
                                      time in the Senate working on the HITECH Act to serving at HHS,
                                      where I played a key role in implementing the Affordable Care Act
                                      and negotiating bipartisan policies with Congress like the 21st
                                      Century Cures Act.
                                         Most recently, I had the privilege of leading Wisconsin’s Depart-
                                      ment of Health Services. I am proud of the work we were able to
                                      accomplish in Wisconsin. There, we found ways to make progress
                                      on a bipartisan basis, expanding access to telehealth services, our
                                      innovative children’s health insurance program to tackle childhood
                                      lead poisoning, and improving delivery of the programs at the De-
                                      partment more broadly to better serve the people of Wisconsin.
                                         And when the pandemic hit, we led with fact, science, and trans-
                                      parency to protect our communities. As every single State did, we
                                      faced challenges in Wisconsin. But we built a strong, State-wide re-
                                      sponse, leveraging government assets and the expertise of our
                                      private-sector partners to build a stable testing and contact tracing
                                      system, reaching our rural communities, and vaccinating Wiscon-
                                      sinites. And it is working. As Senator Baldwin noted, Wisconsin is
                                      among the top States in vaccinating our residents.
                                         When I was previously at HHS, then-Secretary Burwell would
                                      joke that if there was an issue that was going to require bipartisan
                                      cooperation, the team should give it to me. She called my portfolio
                                      the ‘‘common ground agenda.’’ And if I have the honor of being con-
                                      firmed and returning to HHS, that is what I am bringing with me:
                                      a common ground agenda.
                                         First, we must end the COVID pandemic. I know we can all
                                      agree that we have lost far too many Americans to this virus.
                                      President Biden put forward ambitious goals, and Congress has fol-
                                      lowed through, providing the resources to get the job done.
                                         If confirmed, I look forward to implementing the American Res-
                                      cue Plan, getting vaccines in arms, rebuilding the public health
                                      workforce, and securing the Nation’s supply chain.
                                         Second, we must expand access to high-quality, affordable health
                                      care. The American Rescue Plan took a major step in bringing
                                      down the cost of health care for working families, but we cannot
                                      stop there. We must strengthen our Medicare and Medicaid life-
                                      lines, reduce the cost of prescription drugs, better integrate mental
                                      health and substance use disorder treatment into our health-care
                                      system, and ensure our global leadership in research, development,
                                      and innovation.
                                         And finally, we must prioritize human services. HHS has an im-
                                      portant role to play, from caring for children to advancing the
                                      health and well-being of people with disabilities. We must not lose
                                      sight of those core missions.




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                                        HHS faces big challenges. And it is our responsibility to be tire-
                                      less stewards of an agency that touches nearly every aspect of
                                      American life. To me, that is what public service is all about; mak-
                                      ing government work for the people it serves, and leaving the coun-
                                      try better than we found it.
                                        I am ready for the task, and eager to continue serving. Thank
                                      you again for considering my nomination.
                                        The CHAIRMAN. Thank you very much, Ms. Palm. And we will
                                      have some questions here in a bit.
                                        [The prepared statement of Ms. Palm appears in the appendix.]
                                        The CHAIRMAN. Ms. Brooks-LaSure?

                                      STATEMENT OF CHIQUITA BROOKS-LaSURE, NOMINATED TO
                                       BE ADMINISTRATOR, CENTERS FOR MEDICARE AND MED-
                                       ICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN
                                       SERVICES, WASHINGTON, DC
                                         Ms. BROOKS-LASURE. Chairman Wyden, Ranking Member Crapo,
                                      and members of the committee, thank you for considering my nomi-
                                      nation to be the Administrator of the Centers for Medicare and
                                      Medicaid Services. It is humbling to be before you. And thank you
                                      to Senator Menendez for his kind introduction.
                                         My career in public service started at the Office of Management
                                      and Budget, working on CMS’s budget, Medicaid, and CHIP. But
                                      after 9/11, everything changed. It did for the victims of that terrible
                                      tragedy, their families, and for first responders. It also changed for
                                      many of you and for all of us in government service.
                                         For me, my work shifted to finding coverage for dislocated work-
                                      ers in the wake of the attack. I worked closely with the Treasury
                                      Department and key members of the Bush administration to en-
                                      sure that those impacted by this senseless attack had the health
                                      coverage they needed for such a vulnerable time in their lives.
                                         It was inspiring to be part of a bipartisan effort to ensure that
                                      people who lost their jobs as a result of the attack and the eco-
                                      nomic aftermath were able to get the health care they needed. I
                                      took that philosophy and sense of mission with me to the Ways and
                                      Means Committee and then to HHS and CMS, where I led the de-
                                      velopment of policies that expanded coverage to more than 20 mil-
                                      lion Americans.
                                         I have approached my work in the private sector with the same
                                      philosophy, working with States and stakeholders to expand cov-
                                      erage options, especially for those living in rural parts of the coun-
                                      try and for traditionally marginalized communities.
                                         Today, as we navigate this public health crisis and its aftermath,
                                      that philosophy guides me yet again, and if confirmed, that is the
                                      collaborative, common-sense, results-oriented philosophy I will take
                                      to CMS to address the complex challenges we face.
                                         First, we must get the pandemic under control. COVID–19 has
                                      put unbearable pressure on front-line health-care workers, put vul-
                                      nerable seniors and those with disabilities at great risk, and un-
                                      masked inequities that persist in our health-care system. My own
                                      home town, a predominantly black community where my parents
                                      still live, experienced higher rates of COVID infections and deaths
                                      compared to many of our surrounding communities.




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                                        I am committed to working with you and leaders across the gov-
                                      ernment to ensure that CMS is supporting patients, their families,
                                      and providers, including communities of color, who have been hard-
                                      est hit by this pandemic.
                                        If confirmed, I will work to make CMS programs work together
                                      better and remain the pillars of our health-care system. This in-
                                      cludes addressing Medicare solvency to protect Medicare for cur-
                                      rent and future beneficiaries. There is much we can do to strength-
                                      en these programs, to improve quality, lower cost, and expand ac-
                                      cess, including implementing the critical reforms in last December’s
                                      appropriations bill and the American Rescue Plan.
                                        If confirmed, I am also committed to working with you to expand
                                      access to innovative therapies, procedures, and models of care. We
                                      are living in an era of incredible change, as researchers find new
                                      ways to conquer disease and improve our quality of life. We must
                                      bear in mind, though, that innovation is only effective if patients
                                      can actually afford it. So I will work with you to reign in health-
                                      care costs, including for prescription drugs.
                                        I realize we may not always agree on the best approaches to
                                      solve these challenges, but I pledge to work closely with all of you
                                      to ensure that our decisions are transparent, our team is acces-
                                      sible, and that CMS is listening to your views.
                                        Before I close, I would be remiss if I did not acknowledge the out-
                                      pouring of support I have received from women of color across this
                                      country. I am proud that, if I have the honor of being confirmed,
                                      I will be the first black woman to lead CMS. I would not be here
                                      without God and my family, my husband sitting behind me, my
                                      parents, my brother and sister, and the many strong, smart black
                                      women and men who came before me. Too often they were not
                                      given the opportunity to live up to their full God-given potential,
                                      but their selfless, often silent sacrifice paved the way for me and
                                      so many other women of color.
                                        Today, I am proud that my daughter can see her mother nomi-
                                      nated by the President of the United States to lead such a critical
                                      agency and know that she can be anything she wants to be.
                                        Thank you for considering my nomination, and I look forward to
                                      answering your questions.
                                        The CHAIRMAN. Thank you very much, Ms. Brooks-LaSure. And
                                      let the record show that Ms. Brooks-LaSure was also an intern to
                                      the Senate Finance Committee, and so we are very proud of that.
                                        [The prepared statement of Ms. Brooks-LaSure appears in the
                                      appendix.]
                                        The CHAIRMAN. Now, we have some obligatory questions we are
                                      going to ask, and I am just going to ask the question and have a
                                      response from each of you, if that would be all right.
                                        First, is there anything that you are aware of in your background
                                      that might present a conflict of interest with the duties of the office
                                      to which you have been nominated?
                                        Ms. Palm?
                                        Ms. PALM. No.
                                        The CHAIRMAN. Ms. Brooks-LaSure?
                                        Ms. BROOKS-LASURE. No.
                                        The CHAIRMAN. Second, do you know of any reason, personal or
                                      otherwise, that would in any way prevent you from fully and hon-




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                                      orably discharging the responsibilities of the office to which you
                                      have been nominated?
                                         Ms. Palm?
                                         Ms. PALM. No.
                                         The CHAIRMAN. Ms. Brooks-LaSure?
                                         Ms. BROOKS-LASURE. No.
                                         The CHAIRMAN. Third, do you agree, without reservation, to re-
                                      spond to any reasonable summons to appear and testify before any
                                      duly constituted committee of the Congress, if you are confirmed?
                                         Ms. Palm?
                                         Ms. PALM. Yes.
                                         The CHAIRMAN. Ms. Brooks-LaSure?
                                         Ms. BROOKS-LASURE. Yes.
                                         The CHAIRMAN. Finally, do you commit to provide a prompt re-
                                      sponse in writing to any questions addressed to you by any Senator
                                      of the committee?
                                         Ms. Palm?
                                         Ms. PALM. Yes.
                                         The CHAIRMAN. Ms. Brooks-LaSure?
                                         Ms. BROOKS-LASURE. Yes.
                                         The CHAIRMAN. Thank you both.
                                         All right. Let us go on now to members’ questions. We are going
                                      to do this in 5-minute rounds. And let me start with questions for
                                      you, Ms. Brooks-LaSure, and it really speaks to this judgment that
                                      I have had—and I have had two colleagues sitting on my sides who
                                      have shared it with me over the years—which is that I do not be-
                                      lieve the Federal Government has a monopoly on good ideas. If the
                                      States can do better, they ought to be able to do it.
                                         That is why I wrote section 1332 of the Affordable Care Act. It
                                      allows States to get a waiver to put in place fresh and creative
                                      strategies as long as they meet—this is critical—the essential con-
                                      sumer protection guard rails that are embedded in the Affordable
                                      Care Act.
                                         So now, all over the country, there are States that would like to
                                      promote a public option, for example, to increase competition and
                                      hold down health-care costs, and there are some that are interested
                                      in aggregating Medicare and Medicaid dollars because they would
                                      like to move closer to a single-payer approach at the State level.
                                      Conversely, there are States with conservative ideas that would
                                      like to advance what they believe is the right course, and they be-
                                      lieve that they can advance those conservative ideas while meeting
                                      consumer protection guard rails.
                                         The reason I am asking you this question, Ms. Brooks-LaSure, is
                                      you had years of experience working closely with the States. And
                                      if confirmed—I believe, when you are confirmed—you will have au-
                                      thority to be involved in promulgating those kinds of guidance
                                      rules that will give a road map for the States on how to proceed.
                                         How are you looking at your authority with respect to the States,
                                      and particularly ensuring that both progressive States and conserv-
                                      ative States will say they have been treated fairly, showing that
                                      they have good ideas but never fudging on the essential consumer
                                      protection guidelines? How do you see your job in that regard?
                                         Ms. BROOKS-LASURE. Thank you, Chairman Wyden, for the ques-
                                      tion and for your leadership in ensuring that States had an option




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                                      of applying for waivers to think about ways to improve upon the
                                      Affordable Care Act.
                                         As you said, the Federal Government does not have a monopoly
                                      on good ideas and, in fact, some of the best ideas that are eventu-
                                      ally enacted in Washington start at the State level, through waiv-
                                      ers, through demonstrations. And there are so many States that
                                      are looking for the best ways to cover their populations; there is
                                      so much variety in our great country.
                                         I see the role of the Federal Government in granting waivers as
                                      being a trusted partner with the States that have a great deal of
                                      responsibility across the Medicaid program, and in many States,
                                      their marketplaces and certainly their insurance markets. And I
                                      want States to understand what the rules are, to have consistent
                                      guidance, and to make sure they are meeting the standards that
                                      are set forth in the law.
                                         Certainly I agree, and I think that States want to use the 1332
                                      guidance to expand coverage and test different options in many
                                      ways. And if confirmed, CMS will certainly have an open door to
                                      States, to new ideas. And I really want to treat all the States with
                                      consistency and fairness, and then make sure they are meeting the
                                      guard rails.
                                         The CHAIRMAN. One last question on this. Would you make it a
                                      priority to get the guidance out so that States with different philo-
                                      sophical viewpoints would know how to proceed?
                                         Ms. BROOKS-LASURE. Absolutely. States need certainty and are
                                      on important schedules, annual budgets, and that is absolutely im-
                                      portant.
                                         The CHAIRMAN. We will have more conversations about the guid-
                                      ance, and I thank you for that.
                                         Ms. Palm, let us talk about this whole question of health-care eq-
                                      uity. I think you heard me in my opening statement say I think
                                      there are two health-care systems in America, plain and simple.
                                      The most affluent, and particularly those who live in suburbs, have
                                      a technology treasure trove in front of them in terms of how they
                                      can use telehealth and all kinds of services that are beneficial.
                                      Conversely, folks of modest means are just trying to figure out how
                                      to make their way through the maze of rules, even dealing with
                                      COVID services.
                                         So my question to you is, if confirmed—and I believe you will be
                                      confirmed—how would you actually lead at the Department to root
                                      out the significant racial, ethnic, and geographical health dispari-
                                      ties? Because I think that is what this is going to be all about. We
                                      are going to need leadership that has a real agenda to root out
                                      these systematic inequities. Tell us what yours would be.
                                         Ms. PALM. Thank you, Chairman Wyden.
                                         From my perspective, as Deputy Secretary, should I be con-
                                      firmed, I think about this sort of on two levels. One is how we are
                                      working to ensure, at the programmatic and policy development
                                      level, equity and that an equity lens is baked into the development
                                      and implementation of our programs.
                                         And then I lift up and think operationally about how we as a de-
                                      partment are infusing, within our processes, the ways we need to
                                      do the work better, to bake equity in at the beginning so that we
                                      are not chasing it at the end. And so that, for me, is both pro-




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                                      grammatic and policy development, but then also operationally, we
                                      have the opportunity to really structurally change the way we do
                                      our work so that everybody is responsible for equity and making
                                      sure that the work that we do is equitable and that we are elimi-
                                      nating the systemic issues that have brought us to where we are
                                      today.
                                         The CHAIRMAN. I think your point about individual account-
                                      ability—my time is up—is hugely important, because at the end of
                                      the day, these issues have just gotten short shrift. I mean, the
                                      country has known about them, people say that you ought to do
                                      something about it, but it is really time for the kind of account-
                                      ability that you just mentioned.
                                         Senator Crapo?
                                         Senator CRAPO. Thank you very much, Mr. Chairman. And I
                                      want to return in my questioning to the issue that the chairman
                                      dedicated his first question to: that of waivers.
                                         I appreciated the chairman highlighting this issue and the focus
                                      that he brought to it. Waivers are an essential tool for States, al-
                                      lowing them to tailor insurance programs to fit the needs of their
                                      patients. Across the country, States continue to prioritize flexibility
                                      and the use of innovative, local solutions to expand coverage.
                                         Unfortunately, this desire for flexibility has met Federal Govern-
                                      ment roadblocks, and this is especially true for Idaho. As I men-
                                      tioned with both of you privately when we talked, Idaho has tried
                                      numerous creative approaches to expand and coordinate coverage
                                      between certain individual market and Medicaid populations. Med-
                                      icaid 1115 waivers grant important flexibilities for States to im-
                                      prove benefits and to try new ideas in their Medicaid programs.
                                         Obamacare’s 1332 waivers allow States to implement policies
                                      that stabilize the market, lower insurance costs, and incent com-
                                      petition, provided—as Senator Wyden mentioned—that the guard
                                      rails are protected.
                                         Yet when States try to merge the two waivers to coordinate and
                                      expand coverage, they are met with rejection and disappointment
                                      from the Federal Government far too often. This appears to be a
                                      statutory problem in many cases that prevents novel approaches to
                                      creating more seamless, harmonized insurance markets for pa-
                                      tients. Without solving this issue, States must deal with population
                                      churn, inconsistent benefits, budget uncertainty, and the inability
                                      to advance changes that would improve care.
                                         I realize you cannot change the statutes, but I do believe that as
                                      much flexibility as possible to allow States to use these creative op-
                                      tions should be utilized. And I just first want to ask—and I think
                                      you have already basically said this to Senator Wyden—but if con-
                                      firmed, would you work with me and others interested in improv-
                                      ing the 1115 and 1332 waiver coordination through statutes? It is
                                      just a ‘‘yes’’ or ‘‘no’’ for each of you.
                                         Ms. PALM. Yes.
                                         Ms. BROOKS-LASURE. Yes.
                                         Senator CRAPO. And I appreciate that.
                                         And while this waiver work is underway, do you commit to incor-
                                      porating State perspectives and expertise in CMS and HHS
                                      decision-making to ensure that local solutions to address coverage
                                      are included in your work?




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                                         Ms. BROOKS-LASURE. Yes.
                                         Ms. PALM. Yes.
                                         Senator CRAPO. Thank you.
                                         And finally on this, I am deeply concerned by the current admin-
                                      istration’s approach to Medicaid waivers that were granted in the
                                      last administration. In other words, what will be the approach to
                                      waivers that have already been granted? While we should work to
                                      improve evaluations and processes for all waivers and demonstra-
                                      tions, the changes that have occurred this year on Medicaid waiv-
                                      ers necessitate more immediate action.
                                         Ms. Brooks-LaSure, do you believe revoking approved Medicaid
                                      waivers or portions of approved Medicaid waivers immediately fol-
                                      lowing an election sends the wrong message to the States?
                                         Ms. BROOKS-LASURE. Senator Crapo, thank you for raising the
                                      issue, and as I have mentioned, I do a lot of work with States and
                                      understand how much they want certainty from the Federal Gov-
                                      ernment. That is something, if confirmed, I will really work on: to
                                      make sure that States understand decisions and, as you said, are
                                      part of the decision-making.
                                         Senator CRAPO. All right; thank you.
                                         And in the little bit of time I have left, I want to go back to you,
                                      Ms. Brooks-LaSure, on the Medicare Advantage issue.
                                         I am a huge advocate for Medicare Advantage; I think it is one
                                      of the best-working pieces of Medicare, and we should do all we can
                                      to take advantage of it.
                                         During the COVID–19 pandemic, CMS provided Medicare Ad-
                                      vantage plans with additional flexibilities, such as expanding tele-
                                      health services, providing beneficiaries with devices to use for tele-
                                      health and remote patient monitoring, and reducing cost sharing
                                      and premiums, and we found some things that really worked.
                                         Ms. BROOKS-LASURE. Yes.
                                         Senator CRAPO. How would you work with stakeholders and Con-
                                      gress to continue these certain enhanced benefits and flexibilities?
                                      What I am talking about is, why do we have to stop this when the
                                      pandemic ends? Could you respond to that.
                                         Ms. BROOKS-LASURE. Absolutely. I think that this pandemic has
                                      given us an opportunity to take the lessons across a variety of
                                      issues, and telehealth has been something that has been discussed
                                      for more than a decade, and now we have been able to see what
                                      value it brings. My brother is a psychologist, and he has been able
                                      to see more patients during a difficult time as a result of it.
                                         I really want to work with all of you to look at what CMS’s ad-
                                      ministrative authority is and what changes we may need congres-
                                      sionally to work on bringing the lessons that we have learned from
                                      COVID into our health-care system on a permanent basis.
                                         Senator CRAPO. All right. Thank you very much.
                                         My time has expired so, Ms. Palm, I will have to probably send
                                      you some questions for the record.
                                         Ms. PALM. Thank you.
                                         The CHAIRMAN. Colleagues, here is where we are: Senator Stabe-
                                      now will go next in person, then we will have Senator Grassley on
                                      the web, and then we will have Senator Cantwell in person.
                                         Senator Stabenow?




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                                        Senator STABENOW. Thank you very much, Mr. Chairman, and
                                      welcome to Ms. Palm and to Ms. Brooks-LaSure. We are so lucky
                                      to have both of you willing to commit to public service at this very
                                      important time, and I am very impressed with your credentials,
                                      both of you—your experience and your credentials.
                                        I care about every part of the health-care system, as you know.
                                      I have worked for years—it was actually health care that got me
                                      in to my own public service, and I think it is probably no surprise
                                      that I would like to start talking about behavioral health.
                                        And so I would ask both of you—and I know, Ms. Palm, that you
                                      were at HHS when Senator Roy Blunt and I were able to pass the
                                      Excellence in Mental Health and Addiction Services Treatment Act,
                                      and that you were involved in the initial implementation and in es-
                                      tablishing the quality standards. So I appreciate that very much,
                                      and I know you both have been involved in these issues.
                                        But as you know, so many people are living with mental health
                                      issues and addiction issues right now, even more because of
                                      COVID. In January, 41 percent of American adults reported that
                                      they were struggling with anxiety and depression, and that is up
                                      from 11 percent before the pandemic. So we have serious, serious
                                      issues.
                                        And more than one in four young people have reported suicidal
                                      thoughts. Meanwhile, communities are seeing more people over-
                                      dose. Just yesterday the CDC reported that more than 87,000
                                      Americans died of drug overdoses over a 12-month period that
                                      ended in September, the most deaths in a year since the opioid epi-
                                      demic began in the 1990s. Serious alarm.
                                        So long after the epidemic ends, these behavioral health issues
                                      will linger. And I have talked to both of you about—I believe
                                      strongly we need to treat health care above the neck the same as
                                      health care below the neck as part of the health-care system.
                                        The good news is that, through Certified Community Behavioral
                                      Health Clinics that we now have in 41 States—and expanding now
                                      because of the American Rescue plan as well—we have a structure
                                      that allows clinics to truly meet the needs of the community. This
                                      has been a tremendous success, a model for the future, and I have
                                      to commend our chairman on the CAHOOTS program which this
                                      model also embraces as a partnership; so this is so, so important.
                                        And now we have the opportunity to expand it nationwide so
                                      that every State has the opportunity to meet quality standards and
                                      provide comprehensive services. And now is really the time to do
                                      that.
                                        So my question—I will start with Ms. Palm—is, could you talk
                                      about your experience working on behavioral health issues and how
                                      you will work with us to ensure high-quality comprehensive care,
                                      including through the CCBHC program?
                                        Ms. PALM. Yes. Thank you for the question, and thank you for
                                      your leadership on this issue.
                                        I think to your point, the bipartisan nature of the work that you
                                      and Senator Blunt have done on this, the bipartisan work that has
                                      happened around the opioid epidemic, really does afford us a crit-
                                      ical opportunity at this moment to do additional work, to really, as
                                      I mentioned in my opening, integrate behavioral health into the
                                      health-care system. Your analogy of the neck-up and the neck-down




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                                      is exactly right, and I think it is really time that we think about
                                      mental health, substance abuse, the behavioral health issues as
                                      chronic conditions that need to be managed and treated the way
                                      other health-care conditions are; and that the health and wellness
                                      of people and putting them at the center of their health care means
                                      that we have to do that for behavioral health.
                                         I have worked in behavioral health from direct service all the
                                      way to, as you mentioned, implementation of programs, and then
                                      most recently running them at the Department of Health Services
                                      in Wisconsin. And so I would look forward to the opportunity to
                                      work with you and others on this committee to really sort of turn
                                      the crank and take these next important steps in behavioral
                                      health.
                                         Senator STABENOW. Thank you.
                                         Ms. Brooks-LaSure?
                                         Ms. BROOKS-LASURE. I join my colleague in thanking you for
                                      your bipartisan work in this area, and highlighting just how much
                                      of an issue this is and has been. And then as you have stated, with
                                      COVID–19, it has been an incredibly difficult time for a host of
                                      people, including children, for a number of reasons.
                                         I think that one of the important pieces is increasing providers,
                                      which is what the work of your clinic does by making more avail-
                                      ability. We have seen telehealth help in this area. One of the
                                      things, if confirmed, I really want to focus on is helping CMS to
                                      coordinate better with the Department on these critical issues.
                                      States are doing some incredible things in their Medicaid programs
                                      and really coordinating that with the grants from SAMHSA to
                                      make sure that we are integrating behavioral health and substance
                                      abuse with physical health.
                                         And finally I mention, of course, mental health parity is an im-
                                      portant part of CMS’s role of enforcing and ensuring that mental
                                      services are treated equally.
                                         Senator STABENOW. Thank you.
                                         Mr. Chairman, I know my time is up, but I have just one other
                                      thing I want to mention—no question, though—and that is school-
                                      based health clinics. We have authorized school-based health clin-
                                      ics to the end of the year, bipartisan legislation, but they are not
                                      yet funded. And yet we know that children and young adults have
                                      been hit particularly hard by the pandemic, not only anxiety and
                                      depression and other issues, but routine vaccination rates are
                                      down, and many children have missed primary care doctor’s ap-
                                      pointments and dental visits.
                                         So Senator Capito and I are working together to secure funding
                                      for these clinics that have been authorized. We invite all of our col-
                                      leagues to join us. I also want to work with each of you on these
                                      issues to make sure that school-based health centers are able to get
                                      the CHIP funding and Medicaid funding that will allow them again
                                      to be a permanent part of our health-care structure. This is very,
                                      very important for our children.
                                         Thank you, Mr. Chairman.
                                         The CHAIRMAN. Thank you, Senator Stabenow.
                                         Senator Cantwell?
                                         Senator CANTWELL. I thought Senator Grassley was next.
                                         The CHAIRMAN. Excuse me, he is not available right now.




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                                         Senator CANTWELL. Okay; thank you, Mr. Chairman. I just want-
                                      ed to make sure we were not skipping ahead.
                                         Thank you to the witnesses, and congratulations on your nomina-
                                      tions. I certainly support moving you forward.
                                         We have had a chance, at least our CMS nominee, Ms. Brooks-
                                      LaSure, to talk about the basic health plan I mentioned to you;
                                      how in New York approximately 800,000 people are enrolled in a
                                      plan that costs $500—$500—$500 annually for a family of four
                                      buying coverage. That saves $1,000 compared to the silver ex-
                                      change plans, and it saves the State billions of dollars as well. So
                                      I want to make sure that it also saves us federally if more States
                                      implement this.
                                         So I want to hear if both nominees are comfortable with States
                                      expanding this program, and if you would encourage them to do so.
                                      I do not mean to tell them to do so; I mean if they wanted to do
                                      so, would you be encouraging of that?
                                         Can I get it for the record so we can hear you?
                                         Ms. BROOKS-LASURE. Yes, Senator. Absolutely.
                                         Senator CANTWELL. Thank you.
                                         Also I want to make sure that the Department, Ms. Palm, would
                                      assist people in the implementation of that.
                                         Ms. PALM. Absolutely.
                                         Senator CANTWELL. Okay; great.
                                         On Medicaid rebalancing, Senator Portman and I have been very
                                      big supporters. I just want to add that Senator Stabenow was also
                                      a big supporter of the basic health plan, and so I do not want to—
                                      she is very much appreciated, her efforts in getting that imple-
                                      mented; and we would like to continue to see the implementation.
                                         On the Money Follows the Person program, Senator Portman
                                      and I and several others have been continuing to push that, giving
                                      over 8,000 individuals in long-term care facilities the ability to go
                                      back into their homes, saving Medicaid dollars. We feel like this
                                      has been—and rebalancing in general—a big cost savings.
                                         So, Ms. Palm, will you work with States to implement the Money
                                      Follows the Person program to assure seniors and people with dis-
                                      abilities can avoid institutional living?
                                         Ms. PALM. Absolutely.
                                         Senator CANTWELL. Thank you.
                                         And, Ms. Brooks-LaSure, do you support Federal incentives like
                                      those to help States move people from these high-cost institutional
                                      settings?
                                         Ms. BROOKS-LASURE. Yes.
                                         Senator CANTWELL. Okay; great.
                                         My colleague has covered mental health.
                                         So on my colleague from Idaho’s conversation about telehealth,
                                      let’s see if we can get a little more granular here.
                                         What do you think—how do you characterize where the reim-
                                      bursement rate should be? I have had great conversations with the
                                      University of Washington, Paul Ramsey, the CEO of that institu-
                                      tion’s health-care system. So in the Northwest we definitely are
                                      going to support more broadband access; we definitely see how this
                                      worked—you mentioned your brother. I can tell you personally
                                      there are lots of indications in my State of how successful this has




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                                      been. I think we got a real feel—a real feel for the medicine of the
                                      future.
                                        So what do we do about the reimbursement rate? Is it 100 per-
                                      cent; is it the same? Is it slightly different for some reason? Where
                                      do you think we are? And I will start with you, Ms. Brooks-LaSure.
                                        Ms. BROOKS-LASURE. Thank you for the question. I think it is an
                                      incredibly important issue, and one, as you said, that has been
                                      really critical in a number of States, in rural areas. And we need
                                      to think about how we continue to move this issue forward.
                                        Reimbursement, I would say, is something I, if confirmed, would
                                      be happy to talk with you about and think through. There are cer-
                                      tainly safeguards that we need, to make sure, from a program in-
                                      tegrity perspective, that we know that services are being delivered,
                                      but it is one that I think that we will have to titrate but figure out.
                                        Senator CANTWELL. Okay. For somebody who is intellectually
                                      smart on this subject, I consider that a little bit of a punt, but——
                                        I think the issue—I am good with examining the savings, but I
                                      would say to people that this is just a new efficiency discovered in
                                      the information age, with COVID being the thing that prompted us
                                      here. But my guess is, we are going to see huge savings. So I would
                                      say you are at or close to the reimbursement rate that we are at
                                      today. It is almost something we want to incent, just like we have
                                      had pay follow the person, just like we have had these other things.
                                      Why? Because we are going to discover that there are probably sav-
                                      ings here in the system overall.
                                        So anyway, I do not know if you have any comments, Ms. Palm.
                                        Ms. PALM. I would echo what my colleague said. I would also say
                                      we worked hard on a bipartisan bill in Wisconsin to bring tele-
                                      health into the Medicaid program, where we treated them the same
                                      for purposes of coverage and reimbursement, and we were really so
                                      grateful to put that statutory framework in place before the pan-
                                      demic, and we used our flexibilities to really make sure we were
                                      ensuring access during the pandemic.
                                        But I would certainly welcome an opportunity to continue work-
                                      ing with you on this issue.
                                        Senator CANTWELL. Thank you.
                                        Well, Mr. Chairman and Senator Crapo, I think this is an incred-
                                      ibly important subject. We in the Commerce Committee with Sen-
                                      ator Luján will be working on a broadband piece for the medicine
                                      delivery system. And one thing we really like is that we do have,
                                      even in rural communities, rural hospitals everywhere. So they are
                                      a system of delivery, and I think it would be foolish not to try to
                                      pair the broadband investment with the right reimbursement rate,
                                      because otherwise we would be making this investment and giving
                                      us access but not having the utilization because physicians or the
                                      system would continue to defer to see people in person.
                                        So we have to get it right, and I so appreciate my colleagues.
                                      Thank you.
                                        The CHAIRMAN. Senator Cantwell, as always, you are out in front
                                      on these issues. And Senator Crapo and I have been talking about
                                      a bipartisan effort in this telehealth area and as part of the critical
                                      reimbursement issue you mention, because this committee really
                                      shoehorned the telehealth efforts into the first CARES package.




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                                         I think it is going to be important to make sure that right now,
                                      as a result of the pandemic, we have removed some of the road-
                                      blocks for people to actually get to a telehealth provider. We are
                                      going to have to make those kinds of changes permanent, in addi-
                                      tion to working on the critical reimbursement issue you have men-
                                      tioned.
                                         And I want to thank Senator Crapo, because he has indicated
                                      that telehealth could be one of the real bipartisan priorities for the
                                      committee.
                                         Senator CANTWELL. Well, I am pretty sure that the three of us,
                                      whether it is the panhandle of Idaho or eastern Oregon or the
                                      Okanagan in my State, we see a very dispersed rural health-care
                                      delivery system where people have to drive hours. So I think this
                                      would be very helpful.
                                         Thank you, Mr. Chairman.
                                         The CHAIRMAN. Thank you for your leadership.
                                         We are now on to Senator Cassidy on the web, and then Senator
                                      Bennet. Colleagues have a hectic morning, so we are trying in a bi-
                                      partisan way to make sure that everybody gets a chance to be
                                      heard as soon as possible.
                                         Senator Cassidy, I think you are out in cyberspace. So we would
                                      like to hear from you.
                                         Senator CASSIDY. Yes, sir, Mr. Chairman.
                                         Ms. Brooks-LaSure, thanks for reaching out. I enjoyed our con-
                                      versation. As I told you, I was going to follow up on dual eligibles,
                                      not as a ‘‘got you’’ question but rather just kind of to explore it. We
                                      both know that we spend a lot of money in this country on duals,
                                      and we get miserable outcomes.
                                         Now duals are a heterogeneous population, both in terms of who
                                      they are medically but also in terms of the method by which they
                                      are financed. But one thing you pointed out in our conversation is
                                      the difficulty in aligning the incentive for the State and the Federal
                                      Governments.
                                         The ACA attempted to address the duals, and I do not think it
                                      worked. Can you give a little bit of a kind of ‘‘lessons learned’’ from
                                      the ACA’s attempt to address the lack of alignment among duals?
                                         Ms. BROOKS-LASURE. Senator Cassidy, I very much appreciated
                                      our conversation and enjoyed the opportunity to talk. As we talked
                                      about, dual eligibles are sometimes the most vulnerable in our soci-
                                      ety in terms of comorbidities, and often very expensive for both the
                                      Medicare and the Medicaid programs.
                                         I think that, as we talked about, greater alignment is something
                                      that we are going to need to continue to work on. Some of that can
                                      be done by CMS administratively, with getting the programs——
                                         Senator CASSIDY. But let me ask you particularly, what were the
                                      lessons learned from the ACA’s effort? Because I think Minnesota
                                      may have been the only State in which their particular program
                                      worked. And so again I would like to build upon what we have
                                      learned. What have we learned?
                                         Ms. BROOKS-LASURE. I would say—you know, when I look at the
                                      valuation, particularly around Minnesota, what I would say is,
                                      there still is a need to coordinate better on what we see in long-
                                      term care, and the nursing homes, and hospitalization. And some




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                                      of that is going to take legislation and really thinking about how
                                      do we treat people on the continuum?
                                         So particularly in assisted living, PACE programs, I think there
                                      is more we can do to encourage that kind of coordination.
                                         Senator CASSIDY. Ms. Palm, you have been kind of front and cen-
                                      ter on this in your jobs in Wisconsin. What thoughts do you have
                                      about the duals?
                                         Ms. PALM. I appreciate the question, and your point about the
                                      different financing, and States and the feds working together for
                                      us, we were very focused on the continuum of long-term care serv-
                                      ices and providing the opportunity for patients, for seniors, people
                                      with disabilities, to choose care that best met their needs with the
                                      greatest amount of independence. And our ability to do that most
                                      effectively and efficiently would benefit from, as Ms. Brooks-LaSure
                                      mentioned, a greater alignment as you are sort of driving to-
                                      wards——
                                         Senator CASSIDY. Let me stop you for a second. Let me just kind
                                      of stop you for a second. I think one of the things that happened
                                      in California was that there was an incredible amount of churn.
                                      People got assigned to a program, I think run by Medicaid, but
                                      with a Medicare—I may have this wrong, and you guys may know
                                      if I am correct. But this so-called patient choice ended up being
                                      churn where people were changing from program to program sev-
                                      eral times within a year, which of course destroyed continuity of
                                      care. And it begs the question as to whether or not the decision as
                                      to where to receive care was informed, or whether it was perhaps
                                      influenced by those who had other agendas.
                                         Any thoughts upon this? Is there a way to address that? I will
                                      start with you, Ms. Palm.
                                         Ms. PALM. Yes, I would say, Senator, we saw much more churn
                                      in our non-long-term care population in Wisconsin. I am not saying
                                      that what you are raising is not an issue——
                                         Senator CASSIDY. I am saying among duals in general—duals in
                                      general.
                                         Ms. PALM. Yes, I think that, sort of to your fundamental point,
                                      continuity of care, care coordination, making sure that we are put-
                                      ting patients at the center of the care they are receiving, and doing
                                      what we can to do that——
                                         Senator CASSIDY. I guess I am not making my point, Ms. Palm.
                                      Everything you are saying is true. What I am trying to get at is,
                                      how do we address the churn?
                                         Ms. PALM. Well, I think, Senator, from our perspective in Wis-
                                      consin, we wanted to make sure that the products that were avail-
                                      able and the choices that seniors had were transparent on the front
                                      end, that they understood them, and that when they made their
                                      choice, they made a good choice for them so that there were not—
                                      there was not a need to change——
                                         Senator CASSIDY. What was your rate of churn in Wisconsin? I
                                      am just curious; I do not know that answer.
                                         Ms. PALM. Again, I am not sure I can remember off the top of
                                      my head in long-term care versus in the regular population, but I
                                      would be happy to get that information back to you, Senator.
                                         Senator CASSIDY. Okay. I yield back. Thank you.
                                         The CHAIRMAN. I thank my colleague.




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                                         Senator Menendez is next.
                                         Senator MENENDEZ. Thank you, Mr. Chairman.
                                         In March of last year, as COVID began to spread in States like
                                      mine, the shutdowns helped save lives. But at the same time, there
                                      were not systems in place to help individuals who rely on home
                                      and community-based services to continue to access care in such a
                                      situation.
                                         The scarcity of protective equipment meant many providers were
                                      not able to access necessary gear. Fortunately, the American Res-
                                      cue Plan provided an enhanced FMAP for these services.
                                         My question to you is, will you commit to working with States
                                      to swiftly roll out information on how States can spend their in-
                                      creased FMAP for home and community-based services?
                                         Ms. BROOKS-LASURE. Yes, sir.
                                         Senator MENENDEZ. Okay.
                                         COVID–19 has disproportionately impacted black and Latino
                                      communities. I am pleased to see this administration is committed
                                      to improving health equity. However, even as we have seen record-
                                      breaking developments of diagnostic treatments and vaccines for
                                      COVID–19, members of the most heavily impacted communities do
                                      not have equal access to clinical trials for these innovations.
                                         And I believe we have to take active steps to remove these bar-
                                      riers. So, Ms. Brooks-LaSure, what role do you see for CMS to play
                                      in improving minority clinical trial participation?
                                         Ms. BROOKS-LASURE. Thank you, Senator, for the question. This
                                      is such a crucial issue, and I am glad that Congress has made it
                                      so that Medicaid will be paying for covered services, to make sure
                                      that people can get into clinical trials. I think CMS can do more
                                      to integrate with NIH, as well as work with trusted partners.
                                         One of the things that I think we have learned with the pan-
                                      demic is how important it is to have the medical community, com-
                                      munity organizations, really making sure that communities of color
                                      build trust in these types of programs.
                                         Senator MENENDEZ. So will you commit to working with me on
                                      improving clinical trial diversity?
                                         Ms. BROOKS-LASURE. Absolutely.
                                         Senator MENENDEZ. Ms. Palm, the same question to you.
                                         Ms. PALM. Yes, sir.
                                         Senator MENENDEZ. Thank you.
                                         Now throughout the pandemic, Americans have deferred health
                                      care. An October 2020 study in JAMA found that primary care vis-
                                      its declined 21 percent during the second quarter of 2020 as com-
                                      pared to the same time frames in 2018 and 2019.
                                         In particular, I am deeply concerned that delays in cancer and
                                      other screenings will translate into an increase in advanced disease
                                      cases, and ultimately death as a result of millions of Americans
                                      avoiding routine preventative care over the past year. And once
                                      again, I feel these delays in care will disproportionately harm
                                      health-care outcomes for black and Latino communities, who al-
                                      ready have less likely access to preventative care.
                                         So, Ms. Brooks-LaSure, what steps can the Centers for Medicare
                                      and Medicaid Services take to raise awareness and encourage
                                      Americans to seek important and necessary preventative screen-
                                      ings that have been delayed as a result of the pandemic?




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                                        Ms. BROOKS-LASURE. You are so right to raise this issue, with
                                      so many people being concerned about going back to their pro-
                                      viders. Because of the Affordable Care Act, preventative services
                                      across several of the programs are free. Because of its importance,
                                      CMS needs to continue to educate providers, beneficiaries, patients,
                                      and families, and again, working with stakeholders who are trust-
                                      ed partners, to encourage people to get preventative care.
                                        Senator MENENDEZ. Ms. Palm, what additional steps can HHS
                                      take to help raise awareness of this looming issue?
                                        Ms. PALM. It is a great question and really does lend itself to an
                                      opportunity across the Department, through our HRSA programs,
                                      to SAMHSA, to IHS, to the other avenues that we have, to reach
                                      the people that we serve with these messages encouraging folks to
                                      return for care, for the preventative treatment. So we should use
                                      all of our channels as well as our partners to reach people and en-
                                      courage folks to return for care that they need.
                                        Senator MENENDEZ. Finally, I worked on a bipartisan basis with
                                      members from both urban and rural areas at the end of the last
                                      Congress to secure 1,000 new Medicare-supported graduate medical
                                      education slots in the Consolidated Appropriations Act, the first in-
                                      crease in these positions in nearly 25 years.
                                        Senator Boozman and Leader Schumer joined me in reintro-
                                      ducing the Resident Physician Shortage Reduction Act, which
                                      would build upon our bipartisan success by further increasing Fed-
                                      eral support for GME.
                                        Now that Congress has provided the slots, it will be up to the
                                      administration to determine their implementation, and it is impor-
                                      tant that they are distributed in a timely and efficient manner.
                                        How would you plan to ensure smooth implementation of these
                                      critical new GME slots, and how do you envision working with
                                      Congress to address physician shortages?
                                        Ms. BROOKS-LASURE. Thank you, Senator, for your work on this
                                      critical issue. And I very much understand that the congressional
                                      intent is for these slots to go particularly to underserved areas. I,
                                      as we have talked about, want to make sure that we have an open
                                      dialogue, one with public notice and comment where stakeholders
                                      can engage, and certainly an open door to hear your views.
                                        Senator MENENDEZ. I will look forward to working with you on
                                      that.
                                        Thank you, Mr. Chairman.
                                        The CHAIRMAN. Thank you, Senator Menendez.
                                        Senator Bennet has to preside on the floor, so proceed.
                                        Senator BENNET. Thank you, Mr. Chairman, and I thank my col-
                                      leagues for letting me jump in.
                                        Ms. Palm and Ms. Brooks-LaSure, thank you for your willingness
                                      to serve and for all the work you have done to pass and implement
                                      reforms such as the Affordable Care Act, which dramatically im-
                                      proved coverage and affordability for health care in this country.
                                        Despite the ACA’s strides in coverage and affordability, many
                                      Coloradans and many Americans still face high costs and limited
                                      options. The American Rescue Plan expanded eligibility to the ACA
                                      premium tax credit. This capped how much Americans are paying
                                      for health plans on the exchange, which was, I think, very impor-
                                      tant, but still not enough.




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                                         Separately, Senator Kaine and I have previously introduced the
                                      Medicare-X Choice Act. It would work within the Medicare frame-
                                      work to establish a public option for individuals, families, and
                                      small businesses. It would also make the American Rescue Plan
                                      caps permanent.
                                         As you know, President Biden ran on a public option as the an-
                                      swer to creating universal health care in this country, so I would
                                      ask that, if you are confirmed, that you—are both of you committed
                                      to working with me and others on the public option, and when it
                                      passes, implementing it to ensure that every single American has
                                      the health care that they need?
                                         Ms. BROOKS-LASURE. Senator, thank you for your leadership on
                                      this issue, and for passing the American Rescue Plan which, as you
                                      have said, has significantly helped with affordability for middle-
                                      class families and given States options to expand the Medicaid pro-
                                      gram.
                                         Of course we will work with you, and really want to advance the
                                      President’s agenda; and as you said, he is supportive of a public op-
                                      tion.
                                         Senator BENNET. Ms. Palm?
                                         Ms. PALM. I would concur with my colleague. I look forward to
                                      working with you.
                                         Senator BENNET. I think this is something we should get done
                                      now. You mentioned it, Mr. Chairman, in your questions.
                                         The American people, coming through this pandemic, understand
                                      how critical it is for us to have, for everybody to have, access to
                                      primary care. And this was litigated extensively during the cam-
                                      paign, in both the Democratic primary and the general election.
                                         And so I hope the Biden administration will take us up on our
                                      offer to be helpful in fulfilling these commitments, and I look for-
                                      ward to working with the chairman as well.
                                         Children with complex medical needs may not be able to receive
                                      highly specialized care that they need in their home State. This re-
                                      quires families and State Medicaid officials to go through the dif-
                                      ficult process of finding out-of-State providers. Senator Grassley
                                      and I worked hard to pass the ACE Kids Act, which will be imple-
                                      mented in October of 2022 and would enable better care coordina-
                                      tion for these kids to make sure that they get the best services, no
                                      matter where they live.
                                         As a follow-up, last year we introduced the Accelerating Kids Ac-
                                      cess to Care Act. This bill would provide certainty for State Med-
                                      icaid agencies to better determine who is responsible for paying
                                      and reduce regulatory burdens that can slow or prohibit access to
                                      care.
                                         If confirmed, will you commit to a timely implementation of the
                                      ACE Kids Act and work with us on the Accelerating Kids Access
                                      to Care Act so we can make sure we are taking care of the Nation’s
                                      most sick kids.
                                         Ms. Brooks-LaSure?
                                         Ms. BROOKS-LASURE. Yes.
                                         Senator BENNET. Thank you.
                                         Ms. PALM. Yes. I would welcome the opportunity, Senator.
                                         Senator BENNET. Thank you. I would welcome the opportunity
                                      too.




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                                        I guess I have time for one more question, so I am going to ask
                                      one. In December we passed the No Surprises Act, which will end
                                      the practice of surprise billing. I think this was a major step to pro-
                                      tect patients who are often taken advantage of in their most vul-
                                      nerable state. I have been working on that effort for years with
                                      Senators Cassidy and Hassan and others on the committee, and I
                                      am grateful it was signed into law.
                                        Ms. Brooks-LaSure, in your written statement you mentioned
                                      you have the responsibility to implement the legislation when it
                                      goes into effect next year.
                                        Can you highlight your thoughts on eliminating surprise billing
                                      and reiterate your commitment to implement the legislation over
                                      the next year, should you be confirmed?
                                        Ms. BROOKS-LASURE. Thank you, Senator, and thank you to this
                                      committee, which has done so much work. Surprise billing has
                                      been an incredibly difficult issue for patients. Several States, before
                                      you passed legislation, had legislation on the books, but thank
                                      goodness that you all were able to reach a bipartisan agreement
                                      and really make sure the protections are in place.
                                        If confirmed, I will absolutely work very hard to implement the
                                      regulations. I know we are on a very tight timeline, so I hope that
                                      I am so fortunate to be confirmed quickly to help with that effort.
                                        Senator BENNET. Great. Thank you very much for your testi-
                                      mony.
                                        Thank you, Mr. Chairman.
                                        The CHAIRMAN. I thank my colleague.
                                        Senator Carper is next.
                                        Senator CARPER. Good morning. Great to see you both. I enjoyed
                                      talking with you by phone the other day. Thank you for joining us
                                      today, and congratulations on your nominations. We look forward
                                      to a swift confirmation, and the opportunity to work with you for
                                      any number of years.
                                        I have the opportunity—we have a bunch of caucuses here in the
                                      U.S. Senate, as you may know. One of those is called the Senate
                                      Community Health Center Caucus, and the last time I checked, we
                                      have about 1,400 federally qualified community health centers
                                      across the country.
                                        I think one of the smart things this administration has done
                                      early in its tenure is to make sure that people in neighborhoods
                                      across America can go to the federally qualified community health
                                      center and be vaccinated. I think that is a great move, and I think
                                      as we especially reach out to communities of color, folks who are
                                      frankly skeptical of taking the vaccine at all, it is a very wise move.
                                        Ms. Palm, can you think of any other areas where community
                                      health centers could be better leveraged to address rural and eth-
                                      nic health disparities and our pandemic recovery?
                                        Ms. PALM. Thank you for those questions, Senator, and for your
                                      leadership on this issue.
                                        I think from my experience in Wisconsin, I can tell you our part-
                                      nership with our community health centers was critical, both be-
                                      fore the pandemic and during the pandemic. Areas like behavioral
                                      health and their ability to be providers in that space, particularly
                                      in rural communities, were critical assets they brought to the table.
                                      We have a shortage of dentists in the State of Wisconsin, so dental




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                                      care in our community health centers is a critical access issue,
                                      again particularly in rural communities.
                                         But to your point, their ability to reach underserved and ethnic
                                      minority communities is really critical for us to tackle some of
                                      these health disparity issues and deal with those head-on. So I
                                      think there are lots of opportunities for us to continue to work with
                                      those critical partners, and I look forward to doing that.
                                         Senator CARPER. Good.
                                         Ms. LaSure—do people call you ‘‘Ms. LaSure,’’ or do they call you
                                      ‘‘Ms. Brooks-LaSure’’?
                                         Ms. BROOKS-LASURE. They call me Chiquita. [Laughing.]
                                         Senator CARPER. I want so badly to ask you who you are named
                                      after, but I am not going to go there.
                                         Ms. LaSure, as you know, we are not out of the woods yet on the
                                      pandemic. I think we are making some good progress; a lot still to
                                      be done, but it is incredibly important we keep the main thing the
                                      main thing—that is, to get as many people vaccinated as quickly
                                      as we can.
                                         When I was Governor, I was very active with the National Gov-
                                      ernors Association and helped stand up something called the Amer-
                                      ican Legacy Foundation, which was very actively involved in mes-
                                      saging on youth smoking, trying to convince young people not to
                                      use tobacco, and those who were using it to stop. Hugely successful
                                      initiative—hugely successful initiative.
                                         And we are in a situation right now where we need a hugely suc-
                                      cessful messaging process on convincing people to accept vaccina-
                                      tions. And part of that is coming out of the private sector, part of
                                      it is coming out of like NYU, part of it is coming out of a coalition
                                      led by former Governors of, I think of Idaho and Massachusetts.
                                         But I think it is a shared responsibility, and just talk to us, if
                                      you will, about that shared responsibility, the role the Department
                                      of Health and Human Services plays in getting that message out
                                      and convincing people to take the vaccine.
                                         Ms. BROOKS-LASURE. It is so important. Thank you for your lead-
                                      ership in this area, making sure that people know and are aware
                                      that they can get vaccines, that they do not have to pay for them.
                                         I, once again, want to talk about how what I really would like
                                      to see for CMS is to continue to partner with organizations. One
                                      of the things that I have heard over the last couple of months is
                                      how much people want to know, have their providers taken the
                                      vaccine? My brother-in-law, who sees many patients—he is a
                                      nephrologist—got vaccinated in part to make sure his patients
                                      knew he had taken the vaccine. And I think it is critical that we,
                                      if confirmed, at CMS are making sure that all the programs are en-
                                      couraging this; that the plans are encouraging patients to know
                                      that this is an option.
                                         Senator CARPER. One last quick question—and you can answer
                                      this for the record, but answer it a little bit while we are here—
                                      and that is, dealing with drugs, trying to rein in drug prices with
                                      the help of the Senate Finance Committee in Congress—and this
                                      would be for you, Ms. LaSure.
                                         In your testimony, I think you mentioned that, although research
                                      is finding new ways to conquer disease and improve our quality of
                                      life—and this is a quote, I believe, from you—‘‘we must bear in




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                                      mind, though, that innovation is only effective if patients can actu-
                                      ally afford it,’’ close quote.
                                         That being said, in the interest of reining in health-care costs in
                                      collaboration with the committee and Congress, as CMS Adminis-
                                      trator, how do you plan to use your role to address prescription
                                      drug costs? Please.
                                         Ms. BROOKS-LASURE. Thank you. This committee has done so
                                      much bipartisan work on prescription drugs. We have to address
                                      this issue and make sure that we are lowering costs for these inno-
                                      vative medicines; and as Ranking Member Crapo said, we have
                                      seen so much innovation, and we want to make sure that people
                                      have it available.
                                         I want to work with you all to make sure that we lower prescrip-
                                      tion drug costs—and am open to really working closely with you all
                                      on that.
                                         Senator CARPER. Oh, you will have an opportunity in answering
                                      questions for the record to respond more fully, but I really was
                                      looking for, how do you plan to use your rulemaking authority to
                                      address prescription drug costs. I realize we are in this together,
                                      and we look forward to working towards that. Thank you.
                                         The CHAIRMAN. Thank you, Senator Carper.
                                         Senator Grassley?
                                         Senator GRASSLEY. Thank you, Mr. Chairman. I want to take up
                                      where the Senator from Delaware just left off, because Senator
                                      Wyden and I have been working together for well over a year to
                                      lower prescription drug prices. Our bipartisan bill would cap out-
                                      of-pocket costs for seniors at $3,100. It slows the rate of growth of
                                      drug costs, saving the taxpayers $95 billion. Some believe we
                                      should let the government do more than what our bill would do.
                                      I am not sure that CBO is very interested in giving us much cost
                                      savings on that, if any. And some people in CBO would say if you
                                      did more, you would have to limit consumer choice and access to
                                      lifesaving drugs.
                                         I believe that Congress must pass a bipartisan prescription drug
                                      bill if it is going to get done. I suppose if Democrats stuck together,
                                      then you could do it under reconciliation and that argument would
                                      not hold, but I hope that is not the course you go. And I think that
                                      a Wyden-Grassley bill could get 60 votes very easily.
                                         The bill has meaningful provisions to lower drug prices. So is
                                      there any interest in the administration beyond what you told Sen-
                                      ator Carper to working on enacting bipartisan prescription drug
                                      legislation?
                                         Ms. BROOKS-LASURE. Senator Grassley, I so enjoyed our con-
                                      versation and so appreciate your leadership with Chairman Wyden
                                      on this area and this issue, as I know you all care very deeply
                                      about making sure that we lower costs for patients and families.
                                      I have heard it from almost everyone—I think in all of my discus-
                                      sions—how much you all care about prescription drugs, and the ad-
                                      ministration certainly wants to work with Congress to come up
                                      with solutions for patients.
                                         Senator GRASSLEY. And would I assume that that would be in a
                                      bipartisan effort?




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                                         Ms. BROOKS-LASURE. Absolutely, if people are interested—which
                                      I know you are—in lowering costs. The importance is in making
                                      sure we get this right.
                                         Senator GRASSLEY. On rural health care, this is a big item for
                                      me and even for the chairman, because Oregon has a lot rural
                                      areas as well. I led a charge to create a newly voluntary Medicare
                                      payment program called Rural Emergency Hospitals. It is a new
                                      voluntary Medicare designation; I suppose something specifically
                                      for critical access hospitals. It would let hospitals maintain essen-
                                      tial medical services in their communities, like 24/7 emergency
                                      care, outpatient care, ambulance services, and obviously a lot more.
                                      It will also let certain rural hospitals right-size their health-care
                                      infrastructure, letting them provide services that better align with
                                      the needs of their community.
                                         Maybe this is something both of you should comment on; of
                                      course, you do not have to repeat the first person. But for both of
                                      you: can I have your commitment to implement the Rural Emer-
                                      gency Hospital program as quickly as possible—and I suppose as
                                      fairly as possible?
                                         Ms. BROOKS-LASURE. Yes.
                                         Ms. PALM. Yes.
                                         Ms. BROOKS-LASURE. You have my commitment, Senator.
                                         Senator GRASSLEY. Okay. Thank you, and I appreciated that dis-
                                      cussion we had in my office.
                                         This will probably have to be my last question. During the last
                                      2 years as chairman of this committee, I worked to ensure that
                                      HHS’s Office of National Security received access to intelligence
                                      community information. This included information involving
                                      threats to the Nation’s health because of the virus. That office has
                                      gained access to some intelligence community elements, but more
                                      must be done.
                                         On March 8th, I wrote a follow-up letter to HHS and the Director
                                      of National Intelligence, asking what they have done to incorporate
                                      Federal health agencies into the intelligence community. HHS has
                                      failed to respond, so I hope you can help us get a full response to
                                      that letter.
                                         So let me go on to the second question. Do you agree that China
                                      is a significant and consistent bad actor when it comes to stealing
                                      U.S. taxpayer-funded intellectual property and academic research?
                                      If so, what will you do to protect American work products from the
                                      Communist Chinese Government’s theft and espionage activities?
                                         And if you do not feel that way, why.
                                         Ms. PALM. Senator, I will take that one first.
                                         If I am lucky to be confirmed as Deputy Secretary, I think this
                                      just is a place where my office—and where I—will certainly play
                                      a role in making sure, to your point, that HHS is read into intel-
                                      ligence that pertains to our health-care system, our data privacy,
                                      and some of the cyber issues that we hold at the Department.
                                         To your point on intellectual property, I think it is a critical issue
                                      as we think about how we maintain and reassert our leadership in
                                      technology and innovation, and bringing our products to market in
                                      a way that continues to drive the health-care system forward. And
                                      I would look forward to the opportunity to work with you on both
                                      of those issues, should I be confirmed.




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                                         The CHAIRMAN. I thank my colleague.
                                         Senator Cardin——
                                         Senator CARPER. Mr. Chairman, can I be recognized for 30 sec-
                                      onds out of order, please?
                                         The CHAIRMAN. Sure.
                                         Senator CARPER. To our witnesses I will say, I have the privilege
                                      of working along with Sheldon Whitehouse and Ben Cardin and
                                      others on this committee, and on the Environment and Public
                                      Works Committee. We spent a lot of time in the last Congress try-
                                      ing to come to agreement on water infrastructure, clean drinking
                                      water, that sort of thing; wastewater or sanitation stuff.
                                         We came close to getting it done; could not. We came back, and
                                      we were using that as a building block. To work on it, we are going
                                      to be on the floor next week with our water infrastructure legisla-
                                      tion, all bipartisan.
                                         And the other thing is, we spent a lot of time in the last Con-
                                      gress trying to pass service transportation reauthorization, a 5-year
                                      bill, and which we have part of the jurisdiction for; could not get
                                      it done. We are coming back and using what we did last year as
                                      a building block.
                                         I just think you—and Mr. Chairman, you and Senator Grassley,
                                      before he leaves—you fellows did great work, absolutely great
                                      work. And we ought to be using your work as a building block in
                                      this Congress on drug pricing, and I would just urge us to do that.
                                      Thank you.
                                         The CHAIRMAN. I thank my colleague for his kind words. I know
                                      we are going to talk about that topic this afternoon.
                                         Our next member is Senator Cardin, who is on the web.
                                         Senator CARDIN. Thank you, Mr. Chairman, and let me thank
                                      both of our nominees for their willingness to serve our country.
                                         Ms. Palm, I would like to start with a question following up on
                                      Chairman Wyden’s point in regards to minority health and health
                                      disparities. I heard your answer, but I would like to at least call
                                      attention to the fact that we have offices within the Department of
                                      Health and Human Services that are devoted to minority health
                                      and health disparities. We have the National Institute of Minority
                                      Health and Health Disparities, and we have been talking about a
                                      commitment to really deal with the systemic challenges that we
                                      have in health care in America. It came out very clearly in COVID–
                                      19.
                                         So I would ask if you are committed to using every resource we
                                      have, including the direct involvement by your office in the minor-
                                      ity health offices to develop a strategy to make fundamental
                                      changes in our health-care system to help the underserved commu-
                                      nities. Your response?
                                         Ms. PALM. Sir, I appreciate your raising this, and for your leader-
                                      ship in the creation of those components at HHS. And certainly, we
                                      need to integrate them in our work, because I think the challenge
                                      is that we cannot allow those offices to be seen as the only places
                                      where that work happens.
                                         And so it is critical that they exist, but it is critical that we inte-
                                      grate them in a way that helps us all be accountable for the equity
                                      work that we need to do.




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                                         Senator CARDIN. I thank you for that. I agree completely with
                                      that. These offices are critically important, but they need to be in-
                                      tegrated into the overall strategy on our health-care policies.
                                         I also was listening to my colleagues talk about telehealth, and
                                      I certainly concur in their view that telehealth offers tremendous
                                      potential for access to care, particularly in underserved commu-
                                      nities. We have talked about it being available for those who un-
                                      derstand how to use telehealth and have the access to it, but we
                                      also need to make a priority of dealing with the underserved com-
                                      munity, with access to telehealth as well as structural changes
                                      within the reimbursement structure, to allow the development of
                                      telehealth in so many different fields.
                                         We did that during COVID–19; we made some of those provisions
                                      permanent. We need to expand that, and I look forward to working
                                      with you and the other members of the committee as we expand
                                      telehealth.
                                         Ms. Brooks-LaSure, I want to ask you—we had a chance to talk
                                      about the fact that the Department has started the process of fill-
                                      ing the position of Chief Dental Officer. I just really want to under-
                                      score the importance of getting that position filled as soon as pos-
                                      sible. It was vacant during the Trump administration, but it dem-
                                      onstrates a priority within CMS to deal with the issues of oral
                                      health.
                                         So I hope that you will pay attention to getting that position
                                      filled when you are confirmed.
                                         Ms. BROOKS-LASURE. Absolutely, Senator Cardin. You have my
                                      commitment on that, and I want to thank you for your leadership
                                      in keeping the memory alive of the young boy who died because of
                                      lack of dental coverage. It will be a priority of mine to make sure
                                      that the Medicaid and CHIP programs have a dental officer who
                                      is informing the work.
                                         Senator CARDIN. Thank you. Deamonte Driver was that indi-
                                      vidual who died in my State in 2007, and it did change our under-
                                      standing of the importance of oral health care, as policy-makers,
                                      and I am pleased that we took action both in the CHIP program
                                      and in the Affordable Care Act program.
                                         My last point deals with the issue of prescription drugs, and one
                                      area which is totally unacceptable. In the wealthiest Nation in the
                                      world, we have relatively inexpensive drugs that are in drug short-
                                      age because drug manufacturers do not make the same amount of
                                      profit on those drugs as they do on others. In some cases, they are
                                      single-source manufactured drugs.
                                         And I would ask that there be a commitment by both of our
                                      nominees to make sure that that circumstance does not exist in
                                      this country, that we do not have drug shortages of inexpensive
                                      drugs that are not being made available solely because of the lack-
                                      of-profit motive to the private sector.
                                         And if I could have a commitment to work with us to deal with
                                      those drug shortages—let me start first, if I might, with Ms. Palm.
                                         Ms. PALM. Yes. It is a critical issue, Senator. You have my com-
                                      mitment.
                                         Senator CARDIN. Thank you.
                                         Ms. Brooks-LaSure?
                                         Ms. BROOKS-LASURE. And mine as well.




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                                         Senator CARDIN. Thank you.
                                         Thank you, Mr. Chairman.
                                         The CHAIRMAN. Thank you, Senator Cardin.
                                         The next member—and I believe he is on the web—would be
                                      Senator Thune. Is Senator Thune out there in cyberspace?
                                         [No response.]
                                         The CHAIRMAN. All right. Then Senator Brown is next, also on
                                      the web.
                                         Senator BROWN. Thank you, Mr. Chairman. I just want to thank
                                      Senator Cardin for always raising oral health and dental health,
                                      and that is so, so important, both for Medicare, obviously, and
                                      Medicaid, but especially Medicaid and the work that he has done.
                                         Thank you for that.
                                         Thanks to both of the witnesses for their willingness to serve and
                                      for their commitment to reducing health disparities, prioritizing
                                      policies to address social determinants of health. The history of in-
                                      stitutional racism within our health-care system continues to affect
                                      health outcomes for communities of color.
                                         I chair the Banking, Housing, and Urban Affairs Committee. We
                                      just had a hearing yesterday on, from the Black Codes to Jim Crow
                                      to redlining, to the Trump administration locking in discriminatory
                                      housing practices, what that has meant to health care and to
                                      wealth accumulation and inequality and all that. So what you are
                                      doing in health care is so very important.
                                         Ms. Brooks-LaSure, a question first for you. Medicaid and Medi-
                                      care are not just payers; they are powerful tools to advance health-
                                      care quality and access to improve population health outcomes and
                                      act as economic drivers for workers in their communities.
                                         Will you commit to working with my staff and others on this
                                      committee to create and strengthen initiatives across CMS to ad-
                                      dress social determinants of health and reduce health disparities?
                                         Ms. BROOKS-LASURE. Absolutely, Senator. And thank you for
                                      your leadership in this role, this critical issue. And it is certainly
                                      a priority of mine.
                                         Senator BROWN. Thank you. We knew that; we wanted to hear
                                      you say it again. So thank you.
                                         One of the topics I raised with Secretary Becerra at his confirma-
                                      tion hearing was the growing gulf between traditional Medicare
                                      and Medicare Advantage. In recent years, both Congress and HHS
                                      have expanded the scope of benefits available to those enrolled in
                                      Medicare Advantage plans without doing so for those individuals
                                      who choose to remain in traditional Medicare. You have seen what
                                      has happened over 20 years of essentially privatization efforts.
                                         This question is for you both. If confirmed, will you work with
                                      me to ensure all Medicare beneficiaries, whether they are in tradi-
                                      tional Medicare or enrolled in Medicare Advantage plans, have ac-
                                      cess to the same benefits and out-of-pocket protections?
                                         Ms. BROOKS-LASURE. Yes, Senator.
                                         Ms. PALM. Yes, sir.
                                         Senator BROWN. Thank you.
                                         One final issue for Ms. Palm. The Children’s Hospitals Graduate
                                      Medical Education (CHGME) program is of critical importance to
                                      Ohio’s six freestanding children’s hospitals. Senator Casey and I
                                      have for years worked together on a number of children’s issues




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                                      where he has led, and especially with children’s hospitals. Our
                                      States have some of the best children’s hospitals in the country.
                                         Ms. Palm, will you commit to working with Senator Casey and
                                      me and the future head of HRSA to make sure that the Children’s
                                      Hospitals Graduate Medical Education program and training for
                                      the next generation of pediatricians remains a priority for this ad-
                                      ministration?
                                         Ms. PALM. I would be happy to, Senator.
                                         Senator BROWN. Thank you. It has never been easy with any ad-
                                      ministration, by budget time and other things, for GME, for Chil-
                                      dren’s Hospitals GME. So we are counting on you to be a little bit
                                      different and a lot better than some of your predecessors, Ms.
                                      Palm. Thank you so much.
                                         Mr. Chairman, I yield back a minute and 40 seconds.
                                         The CHAIRMAN. Thank you, Senator Brown. Always leading, al-
                                      ways leading.
                                         Senator Thune, are you available now?
                                         [No response.]
                                         The CHAIRMAN. All right. Then we have Senator Casey and Sen-
                                      ator Whitehouse next.
                                         Senator Casey?
                                         Senator CASEY. Mr. Chairman, yes, thank you very much. And
                                      thanks for your leadership on a number of the issues we are going
                                      to raise with our two nominees. Ms. Brooks-LaSure and Ms. Palm,
                                      we are grateful for your willingness to continue public service, es-
                                      pecially at this time.
                                         I wanted to start by talking about an issue that, frankly, we
                                      have not spent enough time on over the last decade in terms of
                                      what the Federal Government does, and that is home and
                                      community-based services.
                                         President Biden’s American Jobs plan calls for a bold investment
                                      in a great American idea, which is Medicaid-only community-based
                                      services. The President has acknowledged what every family in
                                      America already knows to be true: caregiving is part of our basic
                                      American infrastructure. It is part of who we are; it is how we
                                      function. It is part of our efforts to build back better with the em-
                                      phasis on the word ‘‘better.’’ Not the old way, not the way it was
                                      in 2019, but better. And I would hope much better.
                                         Just as our society needs bridges, waterways, and roads to func-
                                      tion, families need services and supports to care for older family
                                      members, to care for people with disabilities, and to care for chil-
                                      dren. The President’s proposal builds on the $12.7 billion of fund-
                                      ing for home and community-based services that was made possible
                                      when Congress passed the American Rescue Plan.
                                         We know that investing in home and community-based services
                                      will, number one, improve the lives of both seniors and people with
                                      disabilities. It will at the same time increase wages and benefits
                                      for workers; and thirdly, it will create jobs, a lot of jobs across the
                                      country.
                                         A majority of these workers are low-income women of color who
                                      earn an average of just $12 an hour. An investment in their work
                                      is not only long overdue, it is consistent with American values. If
                                      we claim to be the greatest country in the world but our home and
                                      community-based services are not anywhere near the best in the




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                                      world, we cannot say we are the country we claim to be. And for
                                      seniors and people with disabilities, access to these services is the
                                      difference between simply just surviving and indeed thriving.
                                         So I would ask both Ms. Brooks-LaSure and Ms. Palm one funda-
                                      mental question, and I am going to ask you both the same ques-
                                      tion. I would ask for your commitment to work with us to secure
                                      funding for these services, the funding the President has outlined,
                                      and thereby realize the President’s vision for home and community-
                                      based services.
                                         Ms. Brooks-LaSure, I will start with you.
                                         Ms. BROOKS-LASURE. Yes; thank you, Senator, for your work on
                                      this issue, and so many of the members of this committee. Yes, I
                                      pledge to work with you on this.
                                         Senator CASEY. Thank you.
                                         Ms. PALM. You have my commitment as well, Senator. This was
                                      a priority in Wisconsin as we looked at the whole continuum of the
                                      long-term care system and making sure that we were modernizing
                                      and preparing for the needs of the future in this system. And it
                                      would be my pleasure to work with you moving forward.
                                         Senator CASEY. Thanks very much. I will stay with Ms. Palm for
                                      this question. I am holding a document which I think I have held
                                      up when we had a virtual engagement; it is called ‘‘Five Freedoms
                                      for America’s Children.’’ This is a document that our staff worked
                                      on for a good long time; we are about to reissue it in an even more
                                      ambitious form.
                                         But when I proposed the ‘‘Five Freedoms for America’s Chil-
                                      dren’’—borrowing directly from Franklin Roosevelt’s ‘‘Four Free-
                                      doms’’—we were focused on, of course, this in a domestic context
                                      for children. But what we wanted to do was put in place a strategy
                                      for America’s children. The good news is, in this long, 33-page, 136-
                                      footnote document that I am very proud of, some of the proposals
                                      in there were achieved in the American Rescue Plan: the great ex-
                                      pansion of the Child Tax Credit, for example; the expansion of the
                                      Child and Dependent Care Credit.
                                         So I would just ask Ms. Palm if you would make a commitment
                                      to working with me—and obviously as one of the leaders of the De-
                                      partment—working with me to get as much of this, of these five
                                      freedoms implemented in the time that you serve.
                                         Ms. PALM. I appreciate the question, and certainly your leader-
                                      ship on this issue. I think to your point, if I am confirmed, the Dep-
                                      uty Secretary has the opportunity to leverage across the Depart-
                                      ment. We touch children in a whole variety of ways, in various pro-
                                      grams at ACF, at SAMHSA, at HRSA, and across the board, and
                                      I would welcome the opportunity to work with you moving forward
                                      on these critical issues.
                                         Senator CASEY. Thanks very much, and, Mr. Chairman, thank
                                      you for working with me on all these issues. We are grateful.
                                         The CHAIRMAN. Thank you.
                                         Senator CASEY. I have one question for the record on nursing
                                      homes.
                                         The CHAIRMAN. Very good. Thank you for your outstanding work.
                                         The order now is Senator Thune next, followed by Senator
                                      Whitehouse and Senator Hassan.
                                         So, Senator Thune.




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                                         Senator THUNE. Thank you, Mr. Chairman.
                                         Ms. Palm, I raised this issue with Secretary Becerra when he
                                      was in front of the committee, but the topic of 340B is enormously
                                      important to hospitals all across South Dakota and across the re-
                                      gion; we have three systems that serve the State but also overlap
                                      into Minnesota and Iowa and Wyoming and Nebraska—places like
                                      that.
                                         And that program has been dysfunctional, I would say, for some
                                      time now. And we have heard concerns recently from covered enti-
                                      ties in my State about actions taken by manufacturers, not reim-
                                      bursing contract pharmacies, all of a sudden deciding to dispense
                                      with that—which they have questionable authority to do—and now
                                      PBMs that are imposing conditions on hospitals in order to get re-
                                      imbursed, to get payment. And that affects their ability to continue
                                      to provide a robust community benefit.
                                         So it is an issue that has been hanging around for a long time;
                                      it is a program, obviously, that Congress has expressed support for
                                      in law, and it seems like a lot of the entities that are designed to
                                      make it work are trying intentionally to undermine the program.
                                         So I am curious, if confirmed, how the Department would re-
                                      spond to ensure that covered entities are not harmed by these ac-
                                      tions taken in that sort of supply chain, if you will, both manufac-
                                      turers and PBMs.
                                         Ms. PALM. Thank you, Senator, for this question. And you are
                                      right. I recall from my previous time at HHS that the 340B pro-
                                      gram was often a topic of conversation, and a challenge. So you are
                                      right, there are things we can and need to be doing in this space.
                                         I think to your point, it is a critical program for our safety net
                                      providers and for the low-income folks who are able to access drugs
                                      through the program. And I, if confirmed, would look forward to
                                      the opportunity to make sure that the program is working as it is
                                      supposed to be working, and that the oversight and implementation
                                      are appropriate so that we really are implementing legislative in-
                                      tent and getting to our safety net providers in low-income commu-
                                      nities the access that they need.
                                         Senator THUNE. Thank you. And I am going to hold you to that
                                      and follow up with you. But thank you for that answer. You are
                                      absolutely right, it needs to be fixed, and I hope that, once con-
                                      firmed, you will help us get on top of this issue as quickly as pos-
                                      sible.
                                         Let me just ask you too, if confirmed: the Indian Health Service
                                      is one of the many operating divisions that would fall under your
                                      purview. As you may know, for several years IHS facilities in the
                                      Great Plains region have struggled with staffing and quality-of-
                                      care issues.
                                         Could you discuss your approach for how you would manage IHS,
                                      drive quality improvements, and ensure accountability to Con-
                                      gress? And maybe the follow-up to that, would you support legisla-
                                      tion that would enable IHS to terminate poor-performing employ-
                                      ees, and also to streamline the hiring process to enable the recruit-
                                      ment of talented health-care professionals?
                                         Ms. PALM. I really appreciate the question, Senator. I think that
                                      IHS is such a unique part of the Department of Health and Human
                                      Services, and when I served previously, I had the opportunity to




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                                      visit an IHS facility in your State, and so I certainly understand
                                      firsthand the need for the work that is before us to make sure that
                                      our tribal communities are receiving the high-quality care that
                                      they need.
                                         So I would look forward—I really appreciate you prioritizing this,
                                      because there is important work that needs to be done here to meet
                                      our mission at HHS as it relates to IHS, and I would look forward
                                      to working with you, both through the work we can do at IHS, but
                                      then you mentioned legislation. I would be happy to work with you
                                      legislatively if there are things we need to do in that space as well.
                                         Senator THUNE. Thank you.
                                         And very quickly, Ms. Brooks-LaSure, CMS plays a significant
                                      role with IHS as a payer and because of its involvement in accred-
                                      iting facilities and assessing compliance with quality and safety
                                      measures.
                                         Over the years, multiple facilities in my State have lost or were
                                      in jeopardy of losing CMS accreditation because of quality issues.
                                      What can we do to improve coordination between IHS and CMS in
                                      holding facilities accountable for delivering the highest quality of
                                      care?
                                         Ms. BROOKS-LASURE. This is a critical issue, and we have to
                                      maintain our commitment, as the government, to work with Indian
                                      populations to make sure they are getting the care that they need.
                                      I pledge to work with my colleague to make sure that IHS and
                                      CMS are coordinating well, and, whether it means that CMS needs
                                      to provide technical assistance or take other steps, we will work
                                      with you on this.
                                         Senator THUNE. Thank you.
                                         And thank you, Mr. Chairman. I would just point out one thing
                                      I forgot to mention. North Dakota is also a State that is impacted
                                      by all these 340B issues; the regional systems that serve South Da-
                                      kota also serve North Dakota.
                                         The CHAIRMAN. Thank you, Senator Thune.
                                         Senator Whitehouse?
                                         Senator WHITEHOUSE. Thank you, Mr. Chairman. Welcome to
                                      both of you. I have 5 minutes to ask you four questions, so I will
                                      try to go quickly, macro to micro.
                                         We have trillions of dollars in debt. Now, 2024 is the first insol-
                                      vency date for Medicare, and as my perennial graph that I have
                                      shown you before shows, something happened in here [pointing to
                                      graph] that has saved $6 trillion in Federal health-care spending
                                      predicted within the next decade. I think that what happened in
                                      here was delivery system reform.
                                         And I am asking that both of you agree that this needs to be a
                                      top priority for CMS and HHS, to figure out why that has hap-
                                      pened and to do more of it. Do you agree?
                                         Ms. BROOKS-LASURE. Yes, Senator. I think that delivery system
                                      reform is critical for addressing costs, making sure that we are de-
                                      livering the care that people need, and CMS will continue to look
                                      at its authority, through the Innovation Center and through the
                                      Medicaid program, to continue to work on these issues.
                                         Ms. PALM. I would echo my colleague and would just suggest that
                                      it is also the opportunity to put patients at the center of care, as
                                      we are thinking about this.




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                                         Senator WHITEHOUSE. Second point: ACOs. We have a lot of real-
                                      ly wonderful ACOs where I live. I have two of the best-performing
                                      ACOs in the country, and it has been a constant battle to defend
                                      the ACOs from you guys trying to pick their pockets before they
                                      really get the reward of the investment that they have made. We
                                      are seeing ACO participation shrinking rather than growing. And
                                      you need to make sure that the ACO lead dogs who are crafting
                                      a new model of care actually get supported and encouraged so that
                                      that model of care can propagate.
                                         Ms. PALM. Senator, you have raised such an important issue,
                                      which is that we want to make sure that our private-sector stake-
                                      holders want to continue to innovate. And, if confirmed, I will work
                                      with you to make sure that our incentives continue to keep inno-
                                      vators wanting to innovate.
                                         Senator WHITEHOUSE. Thank you. We have another project on
                                      end-of-life care where we will ask for waivers of some Medicare
                                      payment regulations that are frankly stupid when they are applied
                                      to this population. And I have been working on this now for 8
                                      years, and every time we get close, there is an administration
                                      change or a personnel change or something, and it is imperative to
                                      get a CMMI waiver to make this happen.
                                         Will you promise that you will work with me to help me get this
                                      CMMI pilot and those requisite waivers?
                                         Ms. BROOKS-LASURE. If confirmed, Senator, I am happy to un-
                                      derstand this demo better and work with you on what we can do
                                      here.
                                         Senator WHITEHOUSE. Yes; I come into this boiling with frustra-
                                      tion because of 8 years of work—and it always falls off the ledge
                                      because of a change in the executive branch. And I am going to get
                                      this done.
                                         Then the last thing is, we are working with medication-assisted
                                      treatment. We have seen telehealth be very helpful in this space.
                                      There is an ongoing conversation about the extent to which that
                                      telehealth engagement needs to be video conference and when it
                                      can be the audio conference. With people who do not have a home
                                      to go to, people who are in perilous circumstances of various kinds,
                                      the audio can be actually necessary, and often can be mediated by
                                      responsible groups that are serving that population.
                                         Can you help me understand the best practices for the video
                                      versus audio and also have somebody from HHS and CMS assigned
                                      to give me advice on where we should be fighting to draw that line:
                                      when is audio okay; when do you actually need it to be video for
                                      medication-assisted treatment in telehealth?
                                         Ms. PALM. Yes, Senator, this is a critical issue. So many under-
                                      served areas struggle with this distinction; and as much as we
                                      have seen telehealth improve care for some, we need to make sure
                                      that it really is available for all. I am happy to talk to you and
                                      learn more about this.
                                         Senator WHITEHOUSE. I will wrap up with the observation that
                                      a lot of people, including our people in our national security estab-
                                      lishment, have said that the biggest issues to America actually are
                                      the debt and deficits, and they go on to say that it appears that
                                      the biggest part in our debt and deficit area is this explosion of
                                      health-care expense. So that begs this question of how you draw




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                                      down without taking benefits from people and making this really
                                      turgid system clear, fast, and efficient and provide people care
                                      early so they do not have the expensive care. That to me is just
                                      such an important priority. I hope you will see it that way. You
                                      may end up being the most important people in government, as I
                                      see it, in solving that problem. Thank you.
                                         The CHAIRMAN. Thank you, Senator Whitehouse.
                                         Senator Hassan?
                                         Senator HASSAN. Well, thank you, Mr. Chair; and I want to
                                      thank you and our ranking member for this hearing. And to our
                                      nominees, thank you both for being here, for your willingness to
                                      serve, for the service you have already provided to your country
                                      and your State, and to your families too.
                                         And I want to associate myself with everything that Senator
                                      Whitehouse just asked you about; and I will just say that I know
                                      Senator Bennet asked about the elimination of surprise medical
                                      bills. I think that, the passage of that legislation to end that prac-
                                      tice, was an example of really patient-focused policy-making. So I
                                      would look forward to working with you both as we implement that
                                      provision and find further ways to really look at our health-care
                                      system from the patient’s perspective. And I appreciate very much
                                      your willingness to do that.
                                         Ms. Palm, I wanted to start with a question to you. As you know,
                                      the COVID–19 pandemic has exacerbated the ongoing substance
                                      use disorder crisis in the country. It is critical that Congress and
                                      HHS work together to ensure that States receive the funding that
                                      they need to support continued access to substance use disorder
                                      treatment and services.
                                         Over the past several years, State opioid response grant funding
                                      has allowed New Hampshire to dramatically expand access to
                                      opioid use disorder treatment and services for Granite Staters. But
                                      under the current funding formula, a significant portion of New
                                      Hampshire State opioid response grant funding is now at risk.
                                         I am working to ensure that States like New Hampshire do not
                                      face dramatic funding cuts that would devastate opioid use dis-
                                      order treatment programs. Will you commit, Ms. Palm, to working
                                      with Congress to ensure that States do not face dramatic cuts in
                                      State opioid response grant funding?
                                         Ms. PALM. Senator, I am so grateful for your leadership on this
                                      issue, and considering what we have seen with the pandemic—we
                                      were making such good progress—we have to double down. And it
                                      is critical that States have the funding that they need to continue
                                      to provide treatment for opioid use disorders.
                                         Senator HASSAN. Thank you very much.
                                         Ms. Brooks-LaSure, I want to turn to you, and I just want to say
                                      that I have two of the most eloquent colleagues in the world, Sen-
                                      ators Menendez and Casey, when it comes to talking about home
                                      and community-based services.
                                         So I will associate myself with their comments about the impor-
                                      tance of it. We know how important it is to individuals and families
                                      to have the choice to get their long-term care at home among famil-
                                      iar faces, in their community, and a chance to really interact with
                                      their loved ones and control their care that way.




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                                         But I want to drill down on a couple of things. Unfortunately,
                                      many individuals who receive care in home and community-based
                                      settings have really faced unique challenges accessing, for instance,
                                      COVID–19 vaccines. And we know that home health workers have
                                      struggled to access the personal protective equipment and COVID–
                                      19 testing that they need to do their jobs safely. Just as we saw
                                      other disparities really highlighted by the pandemic, the disparity
                                      in terms of being either a home health-care patient or a home
                                      health-care worker has really been exacerbated too.
                                         So, following up on the commitment you made to Senators
                                      Menendez and Casey, as CMS Administrator, how would you work
                                      with States to better support home health-care workers and indi-
                                      viduals who receive home and community-based care during the
                                      COVID–19 pandemic?
                                         Ms. BROOKS-LASURE. Thank you, Senator. This issue you raised,
                                      and the other Senators have raised, is such a critical issue. We
                                      want to make sure that people are in the setting that makes the
                                      most sense for them. And if confirmed, you certainly have my com-
                                      mitment to make sure that CMS is doing everything it can do,
                                      whether it is approving waivers or working with States to address
                                      issues; and I would love to follow up with you on this particular
                                      point.
                                         Senator HASSAN. Well, I would look forward to that as well, be-
                                      cause it continues to be a really serious issue.
                                         I have one more question, and it is to Ms. Palm. As the Secretary
                                      of the Wisconsin Department of Health Services, you emphasized
                                      the importance of health data infrastructure in expanding access to
                                      COVID–19 testing.
                                         With the continued emergence of COVID–19 variants, ongoing
                                      surveillance and health data exchange will be essential for tracking
                                      emergent variants and mitigating community spread.
                                         If confirmed, how will you leverage the tools at CMS or through-
                                      out the Department to incentivize health data modernization and
                                      improve data exchange?
                                         Ms. PALM. It is such an important question. I think, more broad-
                                      ly, our data infrastructure, our technology, our modernization of
                                      the way we think about surveillance and data is critical, and it is
                                      a place where HHS can and should help be a leader, so that we
                                      are learning the lessons of what our data infrastructure could do
                                      and could not do; what we need it to do; where we could partner
                                      with the private sector to really maximize our ability to understand
                                      community spread in the example you gave; and how that helps us
                                      get in front of the next surge or the next community that is facing
                                      an outbreak.
                                         And so there is a lot of opportunity there, and I think we really
                                      have to be focused, learn the lessons, and drive that into the next
                                      iteration of how we work on data and the transparency of that data
                                      moving forward.
                                         Senator HASSAN. Thank you very much. I look forward to work-
                                      ing with you on that.
                                         Thank you, Mr. Chair.
                                         The CHAIRMAN. I thank my colleague.
                                         Next is Senator Daines.
                                         Senator DAINES. Thank you, Mr. Chairman.




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                                         Due to the open-border policies of this administration, we are ex-
                                      periencing a public health and, sadly, humanitarian crisis at our
                                      southern border. I saw it firsthand myself; other Senators on this
                                      committee in fact were there as well, including Senator Cornyn just
                                      a few weeks ago.
                                         We had a chance to talk face-to-face with the border patrol
                                      agents, who are overwhelmed by the influx of migrants at the bor-
                                      der. The Donna, TX facility has a capacity of 1,000. With COVID,
                                      they reduced that number to 250. There were 4,200 migrants in
                                      that facility the day we visited, about 21⁄2 weeks ago.
                                         If confirmed, you will help oversee the agency that handles care
                                      for unaccompanied children.
                                         Ms. Palm, do you think the current situation at the southern bor-
                                      der is a crisis?
                                         Ms. PALM. Senator, I am so grateful that you raised this. This
                                      is one of the most pressing issues that HHS is working on right
                                      now; and should I be fortunate enough to be confirmed, I look for-
                                      ward to being part of helping get these children through the system
                                      and placed in safe places with sponsors as quickly as possible.
                                         Senator DAINES. Do you think it is a crisis?
                                         Ms. PALM. I think it is a very urgent need, and——
                                         Senator DAINES. Have you seen it?
                                         Ms. PALM. I have not been to the border.
                                         Senator DAINES. Have you seen the photos of the children in
                                      these overcrowded facilities with no COVID protocols in place? You
                                      know, I come from a northern border State. The northern border
                                      is still virtually shut down. The southern border had 4,200, many
                                      of whom were children, in this facility with a 250-person capacity.
                                      A high percentage of COVID transmission is going on, high positive
                                      COVID test rates.
                                         Have you seen those photos with really no COVID protocols in
                                      place?
                                         Ms. PALM. I have, Senator, and I can tell you as a social worker,
                                      the care and safety of those kids has to be our top priority at HHS,
                                      and if I am confirmed, I certainly will——
                                         Senator DAINES. And you are aware of what is going on across
                                      the Mexican desert with the cartels and the coyotes, the human
                                      trafficking, the abuse of these children that is going on as a result
                                      of creating an incentive by the Biden administration for them to
                                      make that dangerous journey, give their life savings away to the
                                      cartels to come across illegally?
                                         Ms. PALM. I think one of the most important parts of the process
                                      for us in placing these children with sponsors is that screening, to
                                      make sure that those children are going to safe homes, trusted
                                      homes, so that we are—so that human trafficking and those abuse
                                      issues are screened out.
                                         Senator DAINES. Yes, but once you get across the border, the
                                      trafficking issues and the abuse issues have already occurred. This
                                      becomes a question of, how do we prevent that and frankly stop it?
                                         Ms. PALM. Senator, I know that there are—my colleagues across
                                      the administration are looking at the broader issues at play here,
                                      at the root causes and other issues. What I can tell you is, should
                                      I be confirmed, our focus at HHS will be on the safety of those chil-




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                                      dren’s placement in safe homes and finding efficiencies in the sys-
                                      tem so that we are moving them quickly.
                                         Senator DAINES. Thank you. Do you think that the Vice Presi-
                                      dent, who the President has put in charge of resolving the issue at
                                      the southern border, do you think she should be visiting to see
                                      firsthand what is happening on the southern border and witness
                                      conditions that we all saw here 21⁄2 weeks ago?
                                         Ms. PALM. I think the Vice President has been tasked with a
                                      great challenge, and I am sure she is doing everything she needs
                                      to do——
                                         Senator DAINES. Why—we are just curious, why wouldn’t she go
                                      down and see this firsthand? The President has given her explicit
                                      responsibilities. And that was 20 days ago. And she has yet to
                                      show any interest in actually visiting the southern border; has not
                                      shown up.
                                         Ms. PALM. Senator, what I can tell you is, should I be confirmed,
                                      I really want to emphasize the priority that we have on placing
                                      those children as safely and quickly as possible.
                                         Senator DAINES. Throughout the pandemic, assisted living pro-
                                      viders in my home State have cared for over 6,000 vulnerable Mon-
                                      tanans, many of who are living with Alzheimer’s or some form of
                                      dementia.
                                         Due to PPE needs, workforce needs, occupancy deadlines, many
                                      of these providers have suffered millions in losses throughout the
                                      pandemic and will struggle to sustain their operations without fi-
                                      nancial relief. There is about $23 billion remaining in the Provider
                                      Relief Fund to help support our health-care heroes, who are on the
                                      front line of the COVID response. I have urged Secretary Becerra
                                      to distribute more of the remaining PRF to assisted living facilities
                                      and other senior care centers.
                                         Ms. Palm, would you support that kind of request?
                                         Ms. PALM. Yes; to your point, our front-line health-care workers
                                      have borne the brunt of this pandemic. When I was in Wisconsin,
                                      we added additional dollars to what the feds were providing to help
                                      ease the workload and the burden that they were facing.
                                         Senator DAINES. Thank you.
                                         One final question for Ms. Brooks-LaSure.
                                         I founded this pro-life caucus in the United States Senate. I am
                                      deeply committed to protecting the most vulnerable, and that is the
                                      unborn. That is why I was troubled to see the Democrats’ $1.9-
                                      trillion, quote ‘‘rescue package’’ include a taxpayer funding of abor-
                                      tion and numerous provisions, including through Obamacare.
                                         If confirmed, how will you ensure compliance with separate bill-
                                      ing requirements for abortion under section 1303 of Obamacare?
                                         Ms. BROOKS-LASURE. Senator, I will, if confirmed as CMS Ad-
                                      ministrator, absolutely follow the law. And Congress sets that, and
                                      whatever the requirements are, I will meet those.
                                         Senator DAINES. And more specifically, will you require recipi-
                                      ents of abortion-covering plans with zero-cost premiums due to the
                                      expanded tax credits to pay the required abortion coverage sur-
                                      charge of at least a dollar a month?
                                         Ms. BROOKS-LASURE. Senator, I will follow the law. So if that is
                                      the law, I will move forward with whatever you, as Congress, have
                                      passed for me to do. Those are my responsibilities.




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                                         Senator DAINES. Thank you.
                                         The CHAIRMAN. Thank you, Senator Daines.
                                         Next is Senator Cornyn.
                                         Senator CORNYN. Ms. Palm, as I think the chairman will back
                                      me up on this, China has risen to the top of everybody’s agenda,
                                      out of concerns about cybersecurity, cyber-attacks, stealing intellec-
                                      tual property, espionage, obviously with vast national security im-
                                      plications.
                                         So I will ask you some specific questions in writing later on, but
                                      I want to follow up on some of the things that Senator Daines
                                      raised, because it has such a dramatic impact on my State and the
                                      country.
                                         So, if confirmed, you would oversee the Office of Refugee Reset-
                                      tlement, correct?
                                         Ms. PALM. Yes, as part of the Administration for Children and
                                      Families; yes.
                                         Senator CORNYN. And you mentioned that the goal, your goal,
                                      would be to place these children, unaccompanied children, with
                                      sponsors as soon as you could.
                                         Ms. PALM. Yes. Our mission is to find the sponsors, the families,
                                      the relatives to care for these kids while their immigration proc-
                                      esses are proceeding.
                                         Senator CORNYN. And after you have placed them with sponsors,
                                      is the responsibility of the Office of Refugee Resettlement finished?
                                         Ms. PALM. As I understand it, Senator, yes.
                                         Senator CORNYN. Which government agency monitors the welfare
                                      of these children once they are placed with sponsors? Is there any
                                      government agency you are aware of that has that responsibility?
                                         Ms. PALM. It is my understanding—and I’m happy to follow up—
                                      that if there are concerns once they are placed, State child welfare
                                      agencies can become involved in those situations.
                                         Senator CORNYN. Are you aware of the fact that roughly 18 per-
                                      cent of the wellness checks, telephone calls made to the sponsors’
                                      telephone number, go unanswered?
                                         Ms. PALM. I did not know that, sir.
                                         Senator CORNYN. Are you aware of the investigation—the Perma-
                                      nent Subcommittee on Investigations of the Homeland Security and
                                      Governmental Affairs Committee revealed that some unaccom-
                                      panied children, once placed with sponsors, I believe in Ohio, were
                                      put into a forced labor condition. Have you heard of that?
                                         Ms. PALM. I have heard of that, sir, yes.
                                         Senator CORNYN. So do you share my concern for the welfare of
                                      these children once they are placed with these sponsors who may
                                      not even be American citizens, who may not even be related to the
                                      child?
                                         Ms. PALM. Senator, our mission at HHS is the safety and welfare
                                      of those children while they are in our custody; and it is our job
                                      to screen those sponsors before placement; and should I be con-
                                      firmed, I certainly am committed to doing that work.
                                         Senator CORNYN. Well, after they have been placed with the
                                      sponsors, who is supposed to protect these children?
                                         Ms. PALM. Senator, as I mentioned, it is my understanding that,
                                      if there are concerns beyond the placement, our placement and the




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                                      transfer of custody to those sponsors, child welfare agencies may
                                      get involved.
                                         Senator CORNYN. So there may or may not be a report to the
                                      child welfare agencies if these children are put into a forced labor
                                      situation or if they are being trafficked for sex or they are being
                                      recruited into gangs? We are supposed to wait on a report from
                                      somebody that alerts the child welfare system. Is that correct?
                                         Ms. PALM. Senator, it is my understanding that, if there are con-
                                      cerns post-placement by HHS, child welfare agencies may become
                                      involved.
                                         Senator CORNYN. Well, let us talk about while these children are
                                      still in the custody of HHS and the Office of Refugee Resettlement.
                                      Last week my Governor, Governor Abbot, sent a letter to Vice
                                      President Harris with regard to complaints of sexual assault while
                                      the young children, I think they are all males, were located at the
                                      Joe Freeman Coliseum in San Antonio in an HHS facility.
                                         The complaints outlined multiple allegations involving sexual as-
                                      sault, shortage of staff to supervise the children, and reports that
                                      the children were not receiving enough food. There were also com-
                                      plaints that the children who have been exposed to COVID were
                                      not properly isolated from other children who were not, had not
                                      been exposed.
                                         Obviously these allegations, if true, are extremely disturbing.
                                      What steps would you take, if confirmed, to address these sort of
                                      allegations?
                                         Ms. PALM. Senator, these are serious allegations and certainly
                                      ones that I take seriously. Should I be confirmed—I think there are
                                      a couple of things here. From my experience previously but also my
                                      priorities moving forward, there is a zero-tolerance policy for abuse
                                      in HHS facilities. There is an internal investigation and, because
                                      they are mandatory reporters, there also is an external investiga-
                                      tion that comes forward. Staff are removed from the facility pend-
                                      ing that investigation, and that speaks to the seriousness with
                                      which HHS takes allegations around abuse of children in our care.
                                         As it relates to COVID protocols, obviously that is a critical part
                                      of reducing the spread of COVID, and it is my understanding that
                                      CDC is both providing assistance in the development of those pro-
                                      tocols but also that there are CDC folks on the ground at our facili-
                                      ties to help with implementation and to help make sure that what
                                      is necessary is being done. But if there are concerns that that is
                                      not happening, I would look forward to hearing about them and
                                      working with you to make sure that those COVID protocols are in
                                      place and implemented.
                                         The CHAIRMAN. The time of my colleague has expired, and we
                                      still have other Senators waiting.
                                         Senator Warner?
                                         Senator WARNER. Thank you, Mr. Chairman.
                                         And again, Ms. Brooks-LaSure and Ms. Palm, thank you for your
                                      willingness to serve. I have a series of questions.
                                         Over the past decade, a hundred rural hospitals have closed; we
                                      have seen three of those in my State of Virginia. Obviously, the
                                      pandemic has particularly hit the rural communities extra hard,
                                      and rural hospitals extra hard. And it is no coincidence that the




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                                      vast majority of these hospital closures occurred in areas with the
                                      lowest Medicare area wage index rates.
                                         In Virginia, for example, I have been working for 3 or 4 years
                                      in one of our most rural far southwest counties, Lee County, to get
                                      a hospital facility reopened. And they have told me point-blank on
                                      the path to getting it reopened that fixing the Medicare area wage
                                      index would be a huge step in the right direction.
                                         To help solve this problem, we have bipartisan legislation—the
                                      Save Rural Hospitals Act of 2021, with Senators Blackburn, Cor-
                                      nyn, and Warnock—which would establish a reasonable match, no-
                                      minimum Medicare wage index of .85, which would increase Medi-
                                      care payments for rural hospitals in 22 States.
                                         Ms. Brooks-LaSure and Ms. Palm, obviously both HHS and CMS
                                      would play an incredibly important role. I would like you to both
                                      pledge to work with Congress, if you are confirmed, to support
                                      rural hospitals by addressing the problem in the Medicare area
                                      wage system, and any other comments you might have specifically
                                      on how we can guarantee the viability, long-term, of our rural
                                      health system.
                                         Ms. BROOKS-LASURE. Thank you, Senator Warner, for your lead-
                                      ership, and for other members of this committee, who I know very
                                      much care about your rural hospitals, which are in so many areas,
                                      backbones of their communities; and their issues can be different
                                      across the different States.
                                         We will absolutely work with you to make sure that we are sup-
                                      porting rural hospitals in the way that is appropriate, and I want
                                      to work with you on this topic.
                                         Senator WARNER. And specifically on the—you know, the rubber
                                      hits the road on the Medicare area wage system. You will work
                                      with us on that issue specifically as well?
                                         Ms. BROOKS-LASURE. Certainly.
                                         Senator WARNER. Ms. Palm?
                                         Ms. PALM. I look forward to working with you, Senator, on this
                                      issue.
                                         Senator WARNER. And both are very, very important. And I again
                                      think you are going to find broad-based bipartisan support for
                                      changing the ratio to the .85 we have suggested; and again, I look
                                      forward to working with you both on that.
                                         I want to raise another issue, which is the question around dia-
                                      betes and diabetes education. I think we all know—you know, one
                                      in three Americans has diabetes. My home, in Virginia—we have
                                      631,000 Virginians who have diabetes. To try to educate those indi-
                                      viduals—life-style changes have been a bit of a challenge. That na-
                                      tional diabetes prevention program, which again CMS has worked
                                      with, has shown, I think, great results. The problem has been that,
                                      for example in Virginia, we only have one in-person educator for
                                      the whole State.
                                         So with COVID coming, we have been able to show, through tele-
                                      health, that this is a much more efficient delivery model, often-
                                      times again to the rural communities we were just talking about.
                                      So I have legislation, bipartisan with Senator Scott of South Caro-
                                      lina, that would allow a virtual platform to be used. I do not know
                                      if this has come to your attention, Ms. LaSure, but again, it is for
                                      both nominees.




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                                         I would hope you would be willing to take some of the lessons
                                      learned from COVID in delivery of telehealth, particularly on the
                                      education side with diabetes. I think this may be one of the areas
                                      where we have a better solution set now, and my hope would be
                                      that we could make that permanent.
                                         Ms. BROOKS-LASURE. Thank you, Senator Warner. I certainly
                                      have heard, across this discussion, how important telehealth is,
                                      and what a great example of a clear area where it has been helpful.
                                      I really want to work with you and all the members of this com-
                                      mittee to see what we can do certainly, if confirmed, administra-
                                      tively, as well as where we might need congressional help.
                                         Senator WARNER. Ms. Palm?
                                         Ms. PALM. I would welcome the opportunity. I think we learned
                                      in Wisconsin that these flexibilities and the opportunities to be cre-
                                      ative in this space provided us learnings and places where we
                                      ought to maintain those flexibilities; and I would look forward to
                                      working with you.
                                         Senator WARNER. Mr. Chairman, this is an area I hope I could
                                      work with you on as well. I think getting diabetes education on a
                                      virtual platform really makes good sense.
                                         The CHAIRMAN. Absolutely, Senator Warner. I think it is hugely
                                      important. Thank you.
                                         Our next speaker is Senator Cortez Masto.
                                         Senator CORTEZ MASTO. Thank you. Congratulations to both of
                                      you.
                                         Let me just say, in nearly every conversation I have with Nevad-
                                      ans about the pandemic, they mention the toll COVID–19 has
                                      taken on mental health and wellness, from students experiencing
                                      trauma to isolated seniors, to communities of color who have been
                                      hardest hit, and families experiencing severe economic hardship.
                                      No one has been spared in Nevada, and similarly across the coun-
                                      try.
                                         In my view, addressing these impacts should be at the top of
                                      both of your lists. So let me start with—there has been a lot of dis-
                                      cussion about telehealth and telemedicine. Count me in; that is
                                      something that I have seen in my State that should be permanent.
                                      It has brought essential services into our underserved commu-
                                      nities.
                                         But one thing I do want to add, Ms. LaSure, is that utilization
                                      of telehealth services via telephone without any video is just as im-
                                      portant. So I hope, as we look at maybe making this a permanent
                                      infrastructure, we recognize the benefits of both, whether it is
                                      video or just a telephone, working with a patient. Because that has
                                      brought essential services into my communities as well. And I just
                                      want to put that on your radar.
                                         Another area I want to focus on is that, unfortunately, we have
                                      seen high suicide rates in southern Nevada from some of our stu-
                                      dents. And recently, I wrote a letter to Secretary Becerra and Sec-
                                      retary Cardona about my concerns over students’ mental health
                                      and behavioral health. And I asked the Secretaries to work to-
                                      gether to ensure that schools are welcoming kids back to class-
                                      rooms, and they have guidance and best practices at their finger-
                                      tips that incorporate the wealth of knowledge at HHS on dealing
                                      with youth mental health.




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                                         So let me ask, Ms. Palm, as the COO of HHS, how will you work
                                      to ensure that we are leveraging all of the expertise at the Depart-
                                      ment, from ACF’s work with kids in the child welfare system to
                                      SAMHSA’s experience in providing trauma-informed care, to make
                                      sure that we are spending the American Rescue Plan resources as
                                      effectively as possible?
                                         Ms. PALM. I really appreciate the question, Senator, and appre-
                                      ciate your leadership in this space. I think, as we talked about
                                      when we met and here today, it is—if I am fortunate enough to be
                                      confirmed, I think one of the places where the Deputy Secretary’s
                                      office has a real opportunity is in making sure that the whole is
                                      greater than the sum of its parts; that we really are leveraging the
                                      assets and the expertise of the various programs in the Depart-
                                      ment to really put the people that we serve, the American people,
                                      at the center of what we do and the programs that we implement.
                                         And so, whether it is kids’ mental health or other issues, we have
                                      a real opportunity, and I certainly would look forward to working
                                      with you on this issue and others where our coordination and our
                                      ability to work together really does better serve the people of this
                                      country.
                                         Senator CORTEZ MASTO. Thank you.
                                         And staying on the same theme of behavioral health—crisis serv-
                                      ices. So last year, SAMHSA released national guidelines for behav-
                                      ioral health crisis care. This playbook is the product of years of
                                      work by the agency and draws from innovative projects in commu-
                                      nities across the country that are going above and beyond to meet
                                      the needs of individuals experiencing behavioral health services.
                                         This tool is so important because it paints a picture of how we
                                      can build a sustainable continuum of crisis services that we do not
                                      have in Nevada. And similarly, I am hearing from some colleagues
                                      across the country.
                                         I started working with Senator Cornyn on legislation that would
                                      help States stand up crisis services and make them sustainable by
                                      integrating them into both public and commercial insurance plans.
                                         So Ms. Brooks-LaSure, these guidelines are a product of
                                      SAMHSA, but CMS will play an integral role in expanding crisis
                                      services to patients across the country. Can you speak to what you
                                      see as the need for behavioral health crisis services and how you
                                      would work with SAMHSA to make sure that those needs are met?
                                         Ms. BROOKS-LASURE. Thank you for raising this issue and for
                                      your leadership in this area, as we have been talking about today.
                                      What we have seen across our country in terms of mental health
                                      is, we had an issue before COVID, and COVID has absolutely had
                                      such an effect on so many individuals, and particularly students,
                                      as you raise and point out.
                                         One of the things that, if confirmed, I want to make sure of, is
                                      that CMS is really integrating very closely with the other parts of
                                      HHS and with my colleagues. States in the Medicaid program have
                                      a very important role in behavioral health, and many of them are
                                      engaging and working in this area. I think certainly in the Med-
                                      icaid program and others, we want CMS to integrate with
                                      SAMHSA to make sure we are tackling this issue holistically as op-
                                      posed to one part of the agency.




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                                         Senator CORTEZ MASTO. Thank you. And I know my time is up.
                                      I just want to say, you have heard from the discussion, this is such
                                      an important topic for all of my colleagues; we have talked about
                                      this in a bipartisan way, as you can imagine. We look forward to
                                      working with you to really bring additional resources that are nec-
                                      essary to address behavioral health needs across this country.
                                         Thank you again, and congratulations on your nominations.
                                         Ms. BROOKS-LASURE. Thank you.
                                         The CHAIRMAN. I thank my colleague.
                                         Senator Warren is next.
                                         Senator WARREN. Thank you, Mr. Chairman, and congratulations
                                      to our nominees.
                                         It is no secret that our health insurance system, even in the best
                                      of times, leaves millions of people without the coverage that they
                                      need. But because most Americans still depend on their jobs to pro-
                                      vide health coverage, our system performs even worse in a crisis
                                      like the one we are now living through.
                                         Heading into 2020, nearly 30 million people were uninsured.
                                      Then when the coronavirus hit, unemployment spiked, and up to
                                      3 million more people lost their employer-based insurance.
                                         Now President Biden has promised to expand health coverage,
                                      and public programs like Medicare that provide high-quality care
                                      at low cost will be the backbone of that expansion, not for-profit in-
                                      surers that will find any opportunity to shift costs to patients while
                                      they line their own pockets.
                                         So, Ms. Brooks-LaSure, you have testified previously about the
                                      popularity of the Medicare program. Americans aged 65 and up,
                                      and some people with disabilities, are eligible for Medicare right
                                      now, but there are a lot of people, many just below the eligibility
                                      age, who struggle to get high-quality, affordable care through pri-
                                      vate insurance.
                                         Can you just say a word about what are the challenges facing
                                      older Americans who may want Medicare but have not hit their
                                      65th birthday yet?
                                         Ms. BROOKS-LASURE. Thank you, Senator Warren, for your lead-
                                      ership in making sure that policy-makers continue to focus on mak-
                                      ing sure coverage is affordable in this country. The Affordable Care
                                      Act was such an incredible, important first step in making sure
                                      that people had affordable care options. The Congress has just
                                      passed the American Rescue Plan—thank you for that—which is
                                      making such a difference to people on the ground right now who,
                                      as a result of the COVID pandemic, may be struggling to pay for
                                      their health insurance.
                                         Being right below the Medicare-eligible age can be an incredible
                                      challenge for people if they do not have affordable employer-
                                      sponsored insurance. In many States, coverage through the mar-
                                      ketplaces is available to them, and we need to continue to work to
                                      make sure that we have affordable options available for that popu-
                                      lation in particular, as they may want to make decisions about re-
                                      tirement, make decisions about job changes at that point in their
                                      lives.
                                         Senator WARREN. Right. So we have this group of Americans who
                                      are not quite old enough yet for Medicare, but who are sometimes




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                                      struggling to access health care right now, during the time in their
                                      lives when they start to need health-care coverage the most.
                                         As a candidate, President Biden promised to help this group of
                                      Americans by lowering the age of Medicare eligibility to 60 years
                                      old. And doing so would expand Medicare coverage to roughly 23
                                      million people.
                                         Ms. Brooks-LaSure, analysts have shown that lowering the Medi-
                                      care eligibility age to 60 could ensure nearly 2 million previously
                                      uninsured people would get coverage, and it would help reduce pre-
                                      miums for the current Medicare population because it would add
                                      a younger, healthier population to the Medicare risk pool, bene-
                                      fiting the health system overall.
                                         Is that correct?
                                         Ms. BROOKS-LASURE. I am not familiar with that particular
                                      study. I do know that the population you are talking about is abso-
                                      lutely one that—I have worked with States where eligibility for
                                      various programs could be higher, and we need to make sure that
                                      that population has coverage.
                                         Senator WARREN. Well, let me just ask it slightly differently. I
                                      understand if you do not know this particular study, but the gen-
                                      eral principle makes sense.
                                         When we have fewer uninsured people, and when healthier,
                                      younger people join risk pools, that is a good thing, right?
                                         Ms. BROOKS-LASURE. Yes, it is a good thing when healthier,
                                      younger people join this pool.
                                         Senator WARREN. And more people get coverage.
                                         So, Ms. Brooks-LaSure, do you agree with President Biden that
                                      lowering the Medicare eligibility age could strengthen health-care
                                      coverage in America?
                                         Ms. BROOKS-LASURE. I think that the President has outlined sev-
                                      eral important policies, including as you said, the lowering of the
                                      Medicare age; and if confirmed, I will work to implement the poli-
                                      cies of the administration.
                                         Senator WARREN. All right. And I appreciate your answer. I have
                                      to tell you, lowering the Medicare eligibility age to expand coverage
                                      and lower costs is a no-brainer. I know President Biden has talked
                                      about dropping the Medicare age from 65 to 60, but frankly I think
                                      we should go even further. People need low-cost health-care op-
                                      tions, particularly as they get older and need more health care.
                                         Dropping the age to 60 could expand Medicare for 23 million peo-
                                      ple, but dropping the age to 55 could expand it for an additional
                                      14 million people. And doing so has the potential to lower pre-
                                      miums in the Medicare program, and depending on how we struc-
                                      ture it, lower premiums for private health insurance too.
                                         So we have this opportunity to expand Medicare coverage to tens
                                      of millions of Americans, and we cannot waste it. We need to get
                                      this done.
                                         Thank you, Mr. Chairman.
                                         The CHAIRMAN. Thank you, Senator Warren. And Senator War-
                                      ren is raising an important point. I was director of the Gray Pan-
                                      thers for about 7 years before I was elected to Congress, and one
                                      of the things we always talked about is that Medicare, when it
                                      began in 1965, was just half a loaf. It did not cover so many crucial




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                                      needs; dental care, for example, which we have seen during the
                                      pandemic being a particularly urgent priority.
                                         So I think these are critical issues that we are going to be
                                      digging into.
                                         I have a couple more questions, and then we will wrap up. On
                                      the chronic care question—apropos again to how Medicare has
                                      changed. Back in those Gray Panthers days, I taught gerontology
                                      as well. The first question on every exam I gave was, what was the
                                      difference between Medicare Part A and Medicare Part B? Because
                                      that was it. You had hospitals, you had doctors, and you were basi-
                                      cally dealing with acute care.
                                         That is not it anymore. Now the program is overwhelmingly
                                      about chronic illness, and it is increasingly headed that way.
                                         So I have a very specific question. Our bill in 2017 finally put
                                      a stake in the ground that we were going to update the Medicare
                                      guarantee. We did fairly well, in some key pieces. Telehealth would
                                      be one—the Trump administration, your predecessor, Ms. Brooks-
                                      LaSure, did not do much, but at least we got that position—Medi-
                                      care Advantage.
                                         But my question to you is, what are the next steps in your view,
                                      because it seems to me that one of the next crucial priorities for
                                      chronic care is doing more to bring traditional Medicare, which still
                                      covers millions and millions of people, into this circle of better care
                                      for what is overwhelmingly going to be the future of the program.
                                         What are your thoughts on that?
                                         Ms. BROOKS-LASURE. Thank you, Chairman Wyden, for your
                                      leadership in passing the CHRONIC Care Act, and I know that
                                      there has been so much analysis on how effective and helpful that
                                      is, including an article by the late Robert Pear. And Medicare Ad-
                                      vantage has been able to take advantage of the legislation and the
                                      work that you have passed.
                                         I think, as Senator Brown mentioned, it is critically important
                                      that we bring some of the innovations and advantages to tradi-
                                      tional fee-for-service and traditional Medicare. And whether that is
                                      something that we can, if confirmed, look at administratively or
                                      whether that is something we need to come back to Congress for,
                                      I am happy to work with you on this topic.
                                         The CHAIRMAN. Again, I put this in the context, not just if you
                                      are confirmed, but when you are confirmed, because we are deeply
                                      committed to that. I would very much like you all to assign some
                                      staff from the Department to work with us. We will work on a bi-
                                      partisan basis. Then-chairman Hatch and I did that when we wrote
                                      the original bill.
                                         But I just think we have to do more to bring traditional Medicare
                                      into the update of what is, I think to the American people, a guar-
                                      antee of Medicare.
                                         Now, a quick point about prescription drugs, because you have
                                      heard this back and forth and the like. I think we know why this
                                      is such an acutely important issue to millions of people; they just
                                      feel like they are getting mugged at the pharmacy counter.
                                         I mean, insulin prices went up 12-fold in a period of time that
                                      was not very long; the drug is not 12 times better. I mean, it is
                                      just plain old price gouging.




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                                         So I want you to know that what I am in favor of is a policy that
                                      has Medicare negotiate on behalf of the more than 60 million Medi-
                                      care beneficiaries in order to get them a better deal. That is piece
                                      number one.
                                         And the second piece, which we focused on here in the Finance
                                      Committee, is when big pharma is price-gouging, they are going to
                                      lose subsidies. You know, they get subsidies from the Federal Gov-
                                      ernment; if they price gouge on insulin, they are going to lose some
                                      of those subsidies.
                                         And so as you all in the administration, when confirmed, debate
                                      those issues, I want you to hear from me, we ought to be pursuing
                                      both policies: letting Medicare negotiate, because everybody tries to
                                      negotiate, it is just common sense; and we cut subsidies when there
                                      is price-gouging. That will produce more savings for the seniors
                                      and more savings for taxpayers.
                                         Last point, just to send you both off formally, I consider you both
                                      to be eminently qualified, and I think people who review this hear-
                                      ing and look at the record will see considerable bipartisanship.
                                      And, Ms. Palm, I noted that, if confirmed, you would advance the
                                      common-ground agenda. That is pretty conciliatory language. And,
                                      Ms. Brooks-LaSure, you indicated that you would work with Fi-
                                      nance members on several bipartisan issues like the telehealth
                                      question and the 1332 waivers which I talked about at some
                                      length; we do not need to do that again. But I appreciated your
                                      saying that that would be a priority for you when confirmed, in
                                      terms of getting the guidance out.
                                         So, we have had a long hearing today. I just want members to
                                      know I am going to support these two nominees strongly. The
                                      deadline for Senators to submit their questions for the record is 5
                                      p.m., Friday, April 16th.
                                         And with that, the Finance Committee is adjourned.
                                         [Whereupon, at 1 p.m., the hearing was concluded.]




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                                                                         APPENDIX
                                                  ADDITIONAL MATERIAL SUBMITTED FOR THE RECORD



                                      PREPARED STATEMENT OF CHIQUITA BROOKS-LASURE, NOMINATED TO BE ADMINIS-
                                        TRATOR, CENTERS FOR MEDICARE AND MEDICAID SERVICES, DEPARTMENT OF
                                        HEALTH AND HUMAN SERVICES
                                         Chairman Wyden, Ranking Member Crapo, and members of the committee, thank
                                      you for considering my nomination to be the Administrator of the Centers for Medi-
                                      care and Medicaid Services. And thank you to Senators Booker and Menendez for
                                      their kind words.
                                         As a graduate student, one of my first internships was with the Senate Finance
                                      Committee. I remember being so awestruck the first time I saw the committee room
                                      and the important business being done on behalf of the American people. So, it’s
                                      incredibly humbling to sit in front of this committee, this time to testify before you
                                      as President Biden’s nominee to lead CMS.
                                         My career in public service started at the Office of Management and Budget. My
                                      portfolio included CMS’s budget, the Children’s Health Insurance Program, and cov-
                                      erage options for the uninsured.
                                         But after 9/11, everything changed. It did for the victims of that terrible tragedy,
                                      their families, and for first responders. It also changed for many of you, and for ev-
                                      eryone in government service. For me, my work shifted toward finding coverage for
                                      dislocated workers in the wake of the attack. I worked closely with the Treasury
                                      Department and key members of the Bush administration to ensure that those im-
                                      pacted by this senseless attack had health coverage during such a vulnerable time
                                      in their lives.
                                         It was inspiring to be part of a bipartisan effort to ensure that people who lost
                                      jobs as a result of the attack and its impact on the economy were able to get the
                                      health care they needed. I took that philosophy of bipartisanship and sense of mis-
                                      sion to improve health care for patients and families with me to the House Ways
                                      and Means Committee—where I was privileged to work for the members of that
                                      committee on five bills that eventually became law. It’s the philosophy I took to
                                      HHS and CMS—where I led the development of policies needed to implement the
                                      Affordable Care Act and expand coverage to more than 20 million Americans.
                                         I’ve approached my work in the private sector with the same philosophy—working
                                      with States and other stakeholders to expand coverage options, especially for those
                                      living in rural parts of the country and for traditionally marginalized communities.
                                      Today, as we navigate this public health crisis and its aftermath, that philosophy
                                      guides me yet again. If confirmed, that is the collaborative, common-sense, results-
                                      oriented philosophy I’ll take to CMS to address the complex challenges we face.
                                         I am excited by the many opportunities we have to work together to improve
                                      health-care quality, lower costs, and promote better access. I am committed to lead-
                                      ing the agency in a way that ensures it acts with the utmost integrity and upholds
                                      its fiduciary responsibilities. This includes addressing Medicare solvency to protect
                                      Medicare for current and future beneficiaries.
                                         We must get the pandemic under control. COVID–19 has put unbearable pressure
                                      on front-line health-care workers, put vulnerable seniors and those with disabilities
                                      at great risk, and unmasked inequities that persist in our health-care system. I am
                                      committed to working with you and with leaders across government to ensure that
                                      CMS is supporting patients and providers, including communities of color who have
                                      been hardest hit by this pandemic.
                                                                                      (49)




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                                                                                      50
                                         But we cannot wait to deliver better care to patients and families. If confirmed,
                                      I will work to make the programs overseen by CMS work better together to help
                                      the people they serve. Medicare, Medicaid, and coverage on the marketplaces re-
                                      main the pillars of our health-care system, and there is much we can do to strength-
                                      en those programs to improve quality, lower costs, and expand access.
                                         That includes implementing the critical reforms in last December’s appropriations
                                      bill and in the American Rescue Plan, particularly the prohibition on surprise med-
                                      ical bills, the new emergency rural hospital designation, and the expansion of finan-
                                      cial help for working families to buy comprehensive coverage on the marketplaces.
                                         If confirmed, I am also committed to working with you to expand access to innova-
                                      tive therapies, procedures, and models of care. We are living in an era of incredible
                                      change as researchers find new ways to conquer disease and improve our quality
                                      of life. We must bear in mind though, that innovation is only effective if patients
                                      can actually afford it. I will also work with the committee and all of Congress to
                                      rein in health-care costs, including for prescription drugs.
                                         Finally, we must think broadly about health equity. During my career, I’ve seen
                                      how communities of color too often experience worse health outcomes, which we’ve
                                      seen so acutely during this pandemic. Last year in April, my own hometown, a pre-
                                      dominately black community where my parents still live, experienced higher rates
                                      of COVID–19 infections and deaths compared to much of the surrounding commu-
                                      nities. If confirmed, I look forward to working with each of you to expand access
                                      to quality care for all communities.
                                         I realize that members of this committee may not always agree on the best ap-
                                      proaches to solve these challenges. While there may be disagreements on policy, I
                                      pledge to work closely with all members of this committee to ensure that our deci-
                                      sions are transparent, our team is accessible, and that CMS closely listens to and
                                      respects your views and ideas for how we can ensure that CMS’s programs fulfill
                                      their mission to best serve patients, providers, and their communities.
                                         Before I close, I’d also be remiss if I did not acknowledge the outpouring of sup-
                                      port I’ve received from women of color from across the country. I am proud that,
                                      if I have the honor of being confirmed, I will be the first black woman to lead CMS.
                                         And I wouldn’t be here without my family—my husband sitting behind me, my
                                      parents and siblings, and the many strong, smart black women and men who came
                                      before me. Too often, they weren’t given the opportunity to live up to their full God-
                                      given potential. But their selfless, often silent sacrifice paved the way for me and
                                      so many other women of color. Today, I’m proud that my daughter can see her
                                      mother nominated by the President of the United States to lead such a critical agen-
                                      cy—and know that she can be anything she wants to be.
                                         Thank you for considering my nomination, and I look forward to answering your
                                      questions.
                                                                                   ----
                                                             SENATE FINANCE COMMITTEE

                                                  STATEMENT OF INFORMATION REQUESTED
                                                              OF NOMINEE
                                                                   A. BIOGRAPHICAL INFORMATION
                                       1. Name (include any former names used): Current: Chiquita White Brooks-
                                          LaSure; Former: Chiquita Lynn White.
                                       2. Position to which nominated: Centers for Medicare and Medicaid Services Ad-
                                          ministrator.
                                       3. Date of nomination: February 19, 2021.
                                       4. Address (list current residence, office, and mailing addresses):

                                       5. Date and place of birth: March 17, 1975; Philadelphia, PA.
                                       6. Marital status (include maiden name of wife or husband’s name):

                                       7. Names and ages of children:




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                                       8. Education (list all secondary and higher education institutions, dates attended,
                                          degree received, and date degree granted):
                                           Georgetown University.
                                           Dates Attended: August 1997–June 1999.
                                           Degree Received: Master of Public Policy (MPP).
                                           Date Degree Granted: June 1999.
                                           Princeton University.
                                           Dates Attended: September 1992–June 1996.
                                           Degree Received: Bachelor of Arts Degree (AB).
                                           Date Degree Granted: June 1996.
                                           Willingboro High School.
                                           Dates Attended: 8th–12th grade—September 1987–June 1992.
                                           Degree Received: High School Diploma.
                                           Date Degree Granted: June 1992.
                                       9. Employment record (list all jobs held since college, including the title or descrip-
                                          tion of job, name of employer, location of work, and dates of employment for
                                          each job):
                                           Manatt Health Strategies, Manatt, Phelps, and Phillips, LLP.
                                           Managing Director.
                                           January 2016–present.
                                           Washington, DC.
                                           CapView Associates (Consulting).
                                           Senior Advisor.
                                           July–December 2015.
                                           Headquarters: Washington, DC; worked from Melbourne, Australia and Falls
                                           Church, VA.
                                           Commonwealth Fund.
                                           Author.
                                           June–November 2015.
                                           Headquarters: New York, NY; worked from Melbourne, Australia and Falls
                                           Church, VA.
                                           Deakin University.
                                           Visiting Scholar.
                                           May–August 2015.
                                           Melbourne, Australia.
                                           Breakaway Policy (Consulting).
                                           Senior Advisor.
                                           June 2014–January 2015.
                                           Headquarters: Washington, DC; worked from Melbourne, Australia.
                                           U.S. Department of Health and Human Services.
                                           Director of Coverage Policy, Office of Health Reform.
                                           April 2010–December 2012.
                                           Washington, DC.
                                           Centers for Consumer Information and Insurance Oversight (CCIIO), Centers
                                           for Medicare and Medicaid Services (CMS).
                                           Deputy Center Director and Deputy Director for Policy and Regulation.
                                           December 2012–May 2014.
                                           Washington, DC and Bethesda, MD.
                                           U.S. House of Representatives.
                                           Majority Professional Staff, Ways and Means Committee.
                                           November 2007–April 2010.
                                           Washington, DC.
                                           Avalere Health.
                                           Senior Manager/Manager (September 2003–September 2006).
                                           Director (October 2006–October 2007).
                                           Washington, DC.
                                           Office of Management and Budget.
                                           Program Examiner.
                                           July 1999–September 2003.
                                           Washington, DC.




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                                                                                      52
                                          U.S. Senate.
                                          (Unpaid) Intern, Senate Finance Committee.
                                          January–June 1998 (Estimated).
                                          McCarter and English.
                                          Paralegal.
                                          July 1996–July 1997.
                                          Newark, NJ.
                                      10. Government experience (list any current and former advisory, consultative, hon-
                                          orary, or other part-time service or positions with Federal, State, or local gov-
                                          ernments held since college, including dates, other than those listed above):
                                          Advisory: Committee Member, Virginia Health Benefit Exchange (September
                                          2020–present). Upon confirmation, as outlined in my Ethics Agreement, I will
                                          resign from this position. My role is advisory; the committee provides advice to
                                          the Exchange Executive Director and VA State officials as they develop their
                                          State-based exchange in place of the federally facilitated exchange.
                                          Volunteered as one of the two leads for the Biden-Harris Transition Agency Re-
                                          view Team for HHS, October 2020–January 2021.
                                          Consultative: Authored reports for the States of Nevada (January 2021), New
                                          Mexico (December 2018 and January 2019), and Oregon (December 2020). Fur-
                                          ther detail included in response to Question 15.
                                      11. Business relationships (list all current and former positions held as an officer,
                                          director, trustee, partner (e.g., limited partner, non-voting, etc.), proprietor,
                                          agent, representative, or consultant of any corporation, company, firm, partner-
                                          ship, other business enterprise, or educational or other institution):
                                          The following are current positions. Upon confirmation, as outlined in my Eth-
                                          ics Agreement, I will resign from these positions:
                                          Board of directors, FAIR Health. I have served on the board of directors since
                                          Spring 2018. The board of directors provides input on the organization’s stra-
                                          tegic goals and activities and approves the organization’s budget and executive
                                          director’s salary. We receive regular updates on how the organization is per-
                                          forming against its goals and budget and are updated on personnel matters.
                                          Board of directors, Children’s Law Center. I have served on the board of direc-
                                          tors since May 2019. The role of the board of directors includes the activities
                                          and responsibilities listed above for FAIR Health, with the additional responsi-
                                          bility of fundraising. I am also on the Development Subcommittee which assists
                                          with the organization’s fundraising efforts, including planning for the annual
                                          benefit.
                                          Managing Director, Manatt, Phelps, and Phillips, LLP (income, but not equity,
                                          partner).
                                      12. Memberships (list all current and former memberships, as well as any current
                                          and former offices held in professional, fraternal, scholarly, civic, business, char-
                                          itable, and other organizations dating back to college, including dates for these
                                          memberships and offices):
                                          Alfred Street Baptist Church.
                                          Member.
                                          2012–present.
                                          Thursday Network, Auxiliary of the National Urban League.
                                          Member.
                                          2001–2005 (Estimated).
                                          Princeton Evangelical Fellowship (now Princeton Christian Fellowship).
                                          Social Chair: 1995–1996.
                                          Member: 1992–1996.
                                      13. Political affiliations and activities:
                                          a. List all public offices for which you have been a candidate dating back to the
                                              age of 18.
                                              None.
                                          b. List all memberships and offices held in and services rendered to all political
                                              parties or election committees, currently and during the last 10 years prior
                                              to the date of your nomination.




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                                                                                      53
                                              Co-led the Coverage Subcommittee within the volunteer Health Policy Com-
                                              mittee for the Biden Presidential Campaign, Summer 2020.
                                           c. Itemize all political contributions to any individual, campaign organization,
                                              political party, political action committee, or similar entity of $50 or more for
                                              the past 10 years prior to the date of your nomination.
                                              See Table.

                                                         Contribution Description                              Date             Amount

                                      OBAMA FOR AMERICA                                                           2012–08–31      $56.00

                                      OBAMA FOR AMERICA                                                           2012–10–03      $56.00

                                      CALONE FOR CONGRESS                                                         2016–04–27     $250.00

                                      PEOPLE FOR DEREK KILMER                                                     2016–04–27     $250.00

                                      HILLARY FOR AMERICA                                                         2016–07–06     $500.00

                                      HILLARY FOR AMERICA                                                         2016–11–07     $120.00

                                      HILLARY FOR AMERICA                                                         2016–11–07     $250.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2017–09–30     $100.00

                                      ROSEN FOR NEVADA                                                            2018–04–30     $100.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2018–05–29    $1,000.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2018–09–03     $100.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2018–09–03     $100.00

                                      ROSEN FOR NEVADA                                                            2018–09–30     $100.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2018–09–30     $100.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2019–06–10     $500.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2020–02–05     $100.00

                                      DSCC                                                                        2020–04–25     $125.00

                                      BIDEN FOR PRESIDENT                                                         2020–04–25     $125.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2020–04–25     $250.00

                                      BIDEN FOR PRESIDENT                                                         2020–04–29     $250.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2020–07–29     $100.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2020–07–29     $100.00

                                      DNC SERVICES CORP/ DEMOCRATIC NATIONAL
                                       COMMITTEE                                                                  2020–10–11    $1,000.00

                                      WARNOCK FOR GEORGIA                                                         2020–12–08     $250.00


                                      14. Honors and awards (list all scholarships, fellowships, honorary degrees, hon-
                                          orary society memberships, military medals, and any other special recognitions
                                          for outstanding service or achievement received since the age of 18.):
                                          Recognition Award for Ten Years of Federal Service: 2013.
                                          OMB Performance Award: 2002 (Estimated).
                                          Campbell Award for Alumni (Georgetown University): May 2001.
                                          Merit Scholarship (Georgetown University): 1997–1999.




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                                      15. Published writings (list the titles, publishers, dates and hyperlinks (as applica-
                                          ble) of all books, articles, reports, blog posts, or other published materials you
                                          have written):
                                      Publications
                                         Co-author, Senate Concurrent Resolution No. 10 Study: Evaluating Public
                                         Health Insurance Options for Nevada Residents, Nevada Legislative Commis-
                                         sion, January 2021.
                                           Co-author, ‘‘Oregon Public Option Report: An Evaluation and Comparison of
                                           Proposed Delivery Models,’’ Oregon Health Authority, December 17, 2020.
                                           Co-author, ‘‘State Strategies for Overcoming Barriers to Advance Health Eq-
                                           uity,’’ Robert Wood Johnson Foundation’s State Health and Value Strategies
                                           program, November 25, 2020.
                                           Co-author, ‘‘The Federal Government’s Response to the Coronavirus (COVID–
                                           19) Pandemic: Questions and Answers,’’ Robert Wood Johnson Foundation’s
                                           State Health and Value Strategies program, April 22, 2020.
                                           Co-author, ‘‘Building on the Gains of the ACA: Federal Proposals to Improve
                                           Coverage and Affordability,’’ Health Affairs, March 2, 2020.
                                           Author, ‘‘State Medicaid Buy-Ins: Key Questions to Consider,’’ Robert Wood
                                           Johnson Foundation’s State Health and Value Strategies program, April 25,
                                           2019.
                                           Co-author, ‘‘The Landscape of Federal and State Healthcare Buy-In Models:
                                           Considerations for Policymakers,’’ Arnold Ventures, February 2019.
                                           Co-author, ‘‘Quantitative Evaluation of a Targeted Medicaid Buy-In for New
                                           Mexico,’’ Health Action New Mexico and the New Mexico Center on Law and
                                           Poverty, January 31, 2019.
                                           Co-author, ‘‘A Promising Strategy for an Affordable Medicaid Buy-In Option in
                                           Colorado,’’ Colorado Center on Law and Policy, the Colorado Consumer Health
                                           Initiative, and the Bell Policy Center, December 2018.
                                           Co-author, ‘‘Evaluating Medicaid Buy-in Options for New Mexico,’’ Health Ac-
                                           tion New Mexico and the New Mexico Center on Law and Poverty, December
                                           7, 2018.
                                           Co-author, ‘‘Medicaid Buy-in: State Options, Design Considerations and 1332
                                           Implications,’’ Robert Wood Johnson Foundation’s State Health and Value
                                           Strategies program, May 16, 2018.
                                           Co-author, ‘‘Manatt on Medicaid: 10 Trends to Watch in 2018,’’ February 7,
                                           2018.
                                           Co-author, ‘‘Understanding the Rules: Federal Legal Considerations for State-
                                           Based Approaches to Expand Coverage in California,’’ California Health Care
                                           Foundation, February 2, 2018.
                                           Co-author, ‘‘State Marketplace Stabilization Strategies,’’ American Hospital As-
                                           sociation, January 22, 2018.
                                           Co-author, ‘‘Liberating Data to Enable Healthcare Market Transparency: A
                                           Guide for Regulators and Policymaker,’’ Novo Nordisk, March 22, 2016.
                                           Author, ‘‘Increased Transparency and Consumer Protections for 2016 Market-
                                           place Plans,’’ The Commonwealth Fund, December 22, 2015.
                                           Co-author, ‘‘The Insurance Commissioners,’’ Morning Consult Blog, September
                                           2014.
                                           Co-author, ‘‘Chapter Three: Quality of Care,’’ The Healthcare Delivery System:
                                           A Blueprint for Reform, Center for American Progress, October 2008.
                                           Co-author, ‘‘The Medicare Drug Benefit in California: Facts and Figures,’’ Cali-
                                           fornia HealthCare Foundation, September 2006.
                                           Co-author, ‘‘The Medicare Drug Benefit: How Good Are the Options?’’ California
                                           HealthCare Foundation, March 2006.
                                           Co-author, ‘‘The Impact of Enrollment in the Medicare Prescription Drug Ben-
                                           efit on Premiums,’’ Kaiser Family Foundation, October 2005.




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                                         Co-author, ‘‘The Medicare Drug Benefit: Implications for Chronic Disease Care,’’
                                         California HealthCare Foundation, October 2005.
                                         Co-author, ‘‘The Medicare Drug Benefit: Implications for California,’’ California
                                         HealthCare Foundation, April 26, 2005.
                                         Co-author, ‘‘State Disease Medicaid Management: Lessons From Florida,’’
                                         Avalere Health and Duke University, March 2005.
                                      Newsletters
                                         Co-author, ‘‘What a Supreme Court Vacancy Could Mean for the ACA,’’ Manatt
                                         on Health, October 21, 2020.
                                         Co-author, ‘‘House Passes the Heroes Act,’’ COVID–19 Update, May 19, 2020.
                                         Co-author, ‘‘ACA 10th Anniversary Infographic,’’ Manatt on Health, March 23,
                                         2020.
                                         Co-author, ‘‘Georgia Releases Section 1332 and 1115 Waivers,’’ Manatt on
                                         Health, November 20, 2019.
                                         Co-author, ‘‘California Supreme Court: Unpaid Wages Are Not Recoverable
                                         Under PAGA,’’ Retail and Consumer Products Law Roundup, October 11, 2019.
                                         Co-author, ‘‘With 2020 in View, Democrats Outline Healthcare Reform Posi-
                                         tions,’’ Manatt on Health, June 19, 2019.
                                         Co-author, ‘‘Marketplace Roundup: Recent Federal Marketplace Activity Pro-
                                         motes State-Level Policymaking,’’ Manatt on Health, May 2, 2019.
                                         Co-author, ‘‘Medicaid Buy-In and Public Option: The State of Play,’’ Manatt on
                                         Health, February 26, 2019.
                                         Co-author, ‘‘What’s Ahead for Health Policy in 2019,’’ Manatt on Health, Janu-
                                         ary 17, 2019.
                                         Co-author, ‘‘Now on Demand: The Midterm Elections’ Impact on Healthcare—
                                         and Your Organization,’’ Health Update, December 19, 2018.
                                         Co-author, ‘‘CMS Promotes New 1332 Waiver Models, States Weigh Options,’’
                                         Manatt on Health, December 19, 2018.
                                         Co-author, ‘‘The Midterm Elections’ Potential Impact on Healthcare,’’ Manatt on
                                         Health, October 24, 2018.
                                         Co-author, ‘‘New Webinar Series: The Midterm Elections’ Impact on
                                         Healthcare,’’ Health Update, October 23, 2018.
                                         Co-author, ‘‘New Webinar: Are Medicaid Buy-In Proposals Gaining Traction?’’,
                                         Health Update, September 25, 2018.
                                         Co-author, ‘‘State Action on Market Stabilization,’’ Manatt on Health, May 17,
                                         2018.
                                         Co-author, ‘‘States Choosing Divergent Paths for Individual Market Coverage,’’
                                         Manatt on Health, April 11, 2018.
                                         Co-author, ‘‘New Webinar: America’s Multidimensional Opioid Crisis,’’ Manatt
                                         on Health: Medicaid Edition, March 28, 2018.
                                         Co-author, ‘‘The President’s Budget and Shifting Policy on Prescription Drugs,’’
                                         Manatt on Health, February 26, 2018.
                                         Co-author, ‘‘What’s Ahead in 2018,’’ Manatt on Health, January 10, 2018.
                                         Co-author, ‘‘Next Steps on Healthcare Reform,’’ Manatt on Health, August 8,
                                         2017.
                                         Co-author, ‘‘Key BCRA Policy Concerns,’’ Manatt on Health, July 25, 2017.
                                         Co-author, ‘‘Special Edition: Key BCRA Policy Concerns,’’ Manatt on Health,
                                         July 21, 2017.
                                         Co-author, ‘‘BCRA Implications: Affordability of Coverage,’’ Manatt on Health,
                                         July 11, 2017.
                                         Co-author, ‘‘The Better Care Reconciliation Act of 2017,’’ Health Update, June
                                         28, 2017.
                                         Co-author, ‘‘Iowa Submits Sweeping 1332 Waiver Seeking Emergency Relief,’’
                                         Manatt on 1332, June 21, 2017.




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                                          Co-author, ‘‘House Repeal and Replace Bill: The American Health Care Act,’’
                                          Health Update, May 5, 2017.
                                          Co-author, ‘‘New Manatt Webinar, Election 2016: Strategic Implications for
                                          Healthcare,’’ Health Update, January 23, 2017.
                                          Co-author, ‘‘Special Edition: Comparison of Key Repeal and Replace Proposals,’’
                                          Health Update, December 6, 2016.
                                          Co-author, ‘‘The Election’s Impact on Healthcare: Preparing for Potential Sce-
                                          narios,’’ Health Update, September 22, 2016.
                                          Co-author, ‘‘Transparency and Decision Support for Medicaid Managed Care
                                          Consumers,’’ Manatt on Health: Medicaid Edition, June 30, 2016.
                                          Co-author, ‘‘Despite Differences in Coverage Markets, Regulatory Alignment Is
                                          Increasing,’’ Health Update, June 23, 2016.
                                          Co-author, ‘‘Now You Have a Second Chance to Benefit From What Does the
                                          Medicare Part B Drug Payment Model Mean for Hospitals, Physicians and Bio-
                                          pharmaceutical Companies?’’, Health Update, April 26, 2016.
                                          Co-author, ‘‘Liberating Data to Enable Healthcare Market Transparency: A
                                          Guide for Regulators and Policymakers,’’ Health Update, March 23, 2016.
                                      16. Speeches (list all formal speeches and presentations (e.g., PowerPoint) you have
                                          delivered during the past 5 years which are on topics relevant to the position
                                          for which you have been nominated, including dates):
                                          I delivered the following presentations but did not have formal prepared re-
                                          marks or slides for any of these presentations:
                                          Panelist, ‘‘Solutions Over Politics: Improving Healthcare for Every American
                                          Breakout Session,’’ NEXT: Powered by the NewDem Action Fund, October 14,
                                          2020.
                                          Speaker, ‘‘The Midterm Elections: How They May Impact Your Business in 2018
                                          and Beyond,’’ Bloomberg Next Webinar, November 8, 2018.
                                          Panelist, ‘‘Healthcare Exchanges,’’ Democratic Attorneys General Association
                                          Fall Policy Conference, Nashville Tennessee, September 14, 2017.
                                          Speaker, ‘‘The Future of Obamacare Individual Exchange Marketplaces,’’
                                          Leerink Partners’ 2017 Global Healthcare Conference, New York, NY, February
                                          16, 2017.
                                          Co-presenter, ‘‘The Election’s Impact on Healthcare: Preparing for Potential Sce-
                                          narios,’’ PharmaVOICE podcast, September 15, 2016.
                                      17. Qualifications (state what, in your opinion, qualifies you to serve in the position
                                          to which you have been nominated):
                                          My professional background and health policy experience have positioned me to
                                          serve as Centers for Medicare and Medicaid Services (CMS) Administrator. I
                                          have extensive knowledge of CMS, having worked at the agency as Deputy Di-
                                          rector for Policy in the Center for Consumer Information and Insurance Over-
                                          sight (CCIIO). In addition, I have a considerable amount of Federal Government
                                          experience—including my time in Congress, at the Office of Management and
                                          Budget (OMB), and the Department of Health and Human Services (HHS)—and
                                          I am thoroughly familiar with how these institutions work together to best
                                          serve the American people.
                                          I have deep expertise across all of CMS’s areas of responsibility, including Medi-
                                          care, Medicaid, and Affordable Care Act (ACA) coverage. Since the beginning of
                                          my career at OMB, I have worked extensively on Medicaid, the Children’s
                                          Health Insurance Program, and coverage for the uninsured. I also have Medi-
                                          care experience, most notably from my time at the House Ways and Means
                                          Committee, working on Medicare Advantage and Medicare Part D. I was fortu-
                                          nate to play a key role in the passage and implementation of the ACA—first
                                          on the Ways and Means Committee, and then in the Obama administration at
                                          HHS. In this capacity, I focused primarily on expanding access for the unin-
                                          sured through the creation of marketplaces, consumer protections for health
                                          coverage, and tax credits.
                                          In the private sector, I worked with States, consumer groups, and other stake-
                                          holders on options to cover more of the uninsured and underinsured—focusing
                                          on policies to expand access to health insurance coverage and working on strate-




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                                                                                      57
                                           gies to address health equity. This work included exploring the role that Med-
                                           icaid programs can play in addressing maternal mortality—a critical issue dis-
                                           proportionately affecting black and brown women in America. This work has
                                           never been more urgent as we have seen longstanding health disparities illumi-
                                           nated during the COVID–19 pandemic.
                                           My role serving as one of the leads for the Biden-Harris Transition Agency Re-
                                           view Team for HHS provided me a clear picture of the work needed to rebuild
                                           HHS and CMS. Moreover, this experience made clear the ways that CMS can
                                           work better within HHS and across government to address inefficiencies in our
                                           system, and also tackle public health crises such as COVID–19 and health in-
                                           equities.
                                           If I have the honor of being confirmed, my priorities for CMS are integrating—
                                           within CMS and between CMS and other parts of HHS—to make coverage more
                                           affordable for people and make programs work together for the people they
                                           serve. If our health-care system is better integrated, we will not only be better
                                           prepared for the next public health crisis, but also better equipped to advance
                                           health equity and improve health-care access and coverage. If confirmed, I
                                           would seek to advance payment reforms while promoting equity and health-care
                                           coverage—and also working with Congress to reduce prescription drug costs for
                                           seniors, people with disabilities, and other consumers.
                                           It would be an honor and a privilege to be confirmed by the Senate to lead
                                           CMS. And the significance of my nomination and possibility that I would be the
                                           first black woman confirmed to this role are not lost on me. After several dec-
                                           ades working on health policy on Capitol Hill, in the Obama administration,
                                           and in the private sector, I believe I have the experience and judgment needed
                                           to lead CMS during this critical time—not only to recover from the pandemic,
                                           but to ensure that all Americans have access to quality, affordable health care
                                           no matter their zip code.

                                                          B. FUTURE EMPLOYMENT RELATIONSHIPS
                                       1. Will you sever all connections (including participation in future benefit arrange-
                                          ments) with your present employers, business firms, associations, or organiza-
                                          tions if you are confirmed by the Senate? If not, provide details.
                                           Upon consultation with and approval by my agency ethics officials, I will receive
                                           a performance-based bonus for calendar year 2020 in three installments and an
                                           additional contribution to my Manatt, Phelps, and Phillips, LLP defined con-
                                           tribution plan.
                                       2. Do you have any plans, commitments, or agreements to pursue outside employ-
                                          ment, with or without compensation, during your service with the government?
                                          If so, provide details.
                                           No.
                                       3. Has any person or entity made a commitment or agreement to employ your
                                          services in any capacity after you leave government service? If so, provide de-
                                          tails.
                                           No.
                                       4. If you are confirmed by the Senate, do you expect to serve out your full term
                                          or until the next presidential election, whichever is applicable? If not, explain.
                                           Yes.

                                                            C. POTENTIAL CONFLICTS OF INTEREST
                                       1. Indicate any current and former investments, obligations, liabilities, or other
                                          personal relationships, including spousal or family employment, which could in-
                                          volve potential conflicts of interest in the position to which you have been nomi-
                                          nated.
                                           Any potential conflict of interest will be resolved in accordance with the terms
                                           of my ethics agreement, which was developed in consultation with ethics offi-
                                           cials at the Department of Health and Human Services and the Office of Gov-
                                           ernment Ethics. I understand that my ethics agreement has been provided to
                                           the committee. I am not aware of any potential conflict other than those ad-
                                           dressed by my ethics agreement.




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                                       2. Describe any business relationship, dealing, or financial transaction which you
                                          have had during the last 10 years (prior to the date of your nomination), wheth-
                                          er for yourself, on behalf of a client, or acting as an agent, that could in any
                                          way constitute or result in a possible conflict of interest in the position to which
                                          you have been nominated.
                                           Any potential conflict of interest will be resolved in accordance with the terms
                                           of my ethics agreement, which was developed in consultation with ethics offi-
                                           cials at the Department of Health and Human Services and the Office of Gov-
                                           ernment Ethics. I understand that my ethics agreement has been provided to
                                           the committee. I am not aware of any potential conflict other than those ad-
                                           dressed by my ethics agreement.
                                       3. Describe any activity during the past 10 years (prior to the date of your nomina-
                                          tion) in which you have engaged for the purpose of directly or indirectly influ-
                                          encing the passage, defeat, or modification of any legislation or affecting the ad-
                                          ministration and execution of law or public policy. Activities performed as an
                                          employee of the Federal government need not be listed.
                                           In the last 5 years as a managing director at Manatt, I have been involved in
                                           legislative and public policy issues at the local and State level (as summarized
                                           in my list of publications and discussed in my ethics agreement). I have testified
                                           one time before Congress:
                                           On June 12, 2019, I testified before the U.S. House of Representatives Ways
                                           and Means Committee regarding universal health coverage. The hearing was ti-
                                           tled, ‘‘Pathways to Universal Health Coverage.’’
                                       4. Explain how you will resolve any potential conflict of interest, including any
                                          that are disclosed by your responses to the above items.
                                           Any potential conflict of interest will be resolved in accordance with the terms
                                           of my ethics agreement, which was developed in consultation with ethics offi-
                                           cials at the Department of Health and Human Services and the Office of Gov-
                                           ernment Ethics. I understand that my ethics agreement has been provided to
                                           the committee. I am not aware of any potential conflict other than those ad-
                                           dressed by my ethics agreement.
                                       5. Two copies of written opinions should be provided directly to the committee by
                                          the designated agency ethics officer of the agency to which you have been nomi-
                                          nated and by the Office of Government Ethics concerning potential conflicts of
                                          interest or any legal impediments to your serving in this position.
                                           I understand that my ethics agreement has been provided to the committee.

                                                                   D. LEGAL AND OTHER MATTERS
                                       1. Have you ever been the subject of a complaint or been investigated, disciplined,
                                          or otherwise cited for a breach of ethics for unprofessional conduct before any
                                          court, administrative agency (e.g., an Inspector General’s office), professional as-
                                          sociation, disciplinary committee, or other ethics enforcement entity at any
                                          time? Have you ever been interviewed regarding your own conduct as part of
                                          any such inquiry or investigation? If so, provide details, regardless of the out-
                                          come.
                                           No.
                                       2. Have you ever been investigated, arrested, charged, or held by any Federal,
                                          State, or other law enforcement authority for a violation of any Federal, State,
                                          county, or municipal law, regulation, or ordinance, other than a minor traffic
                                          offense? Have you ever been interviewed regarding your own conduct as part
                                          of any such inquiry or investigation? If so, provide details.
                                           No.
                                       3. Have you ever been involved as a party in interest in any administrative agency
                                          proceeding or civil litigation? If so, provide details.
                                           No.
                                       4. Have you ever been convicted (including pleas of guilty or nolo contendere) of
                                          any criminal violation other than a minor traffic offense? If so, provide details.
                                           No.




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                                       5. Please advise the committee of any additional information, favorable or unfavor-
                                          able, which you feel should be considered in connection with your nomination.
                                          N/A.
                                                               E. TESTIFYING BEFORE CONGRESS
                                       1. If you are confirmed by the Senate, are you willing to appear and testify before
                                          any duly constituted committee of the Congress on such occasions as you may
                                          be reasonably requested to do so?
                                          Yes.
                                       2. If you are confirmed by the Senate, are you willing to provide such information
                                          as is requested by such committees?
                                          Yes.
                                                                                   ----
                                               QUESTIONS SUBMITTED FOR THE RECORD TO CHIQUITA BROOKS-LASURE
                                                              QUESTIONS SUBMITTED BY HON. RON WYDEN
                                                                          NURSING HOME QUALITY

                                        Question. The crisis of COVID–19 in nursing homes has been a collision of mis-
                                      management at every level of the industry from government regulators to individual
                                      facilities. More than 175,000 people living and working in the Nation’s long-term
                                      care facilities have died of COVID–19, including more than 130,000 in nursing
                                      homes participating in Medicare and Medicaid. The Senate Finance Committee
                                      heard from witnesses during a hearing on March 17, 2021 about ongoing issues in
                                      nursing homes that negatively affect patient care like understaffing, poor infection
                                      control and inadequate emergency preparedness. These issues have persisted for
                                      decades and left facilities particularly ill-prepared for a public health crisis like the
                                      COVID–19 pandemic. If confirmed, what would you do to improve the care provided
                                      in our Nation’s nursing homes?
                                        Answer. It has been heartbreaking to see how hard the COVID–19 pandemic has
                                      hit the Nation’s nursing homes, and as you noted, nursing home safety is not an
                                      issue newly created by the pandemic. Nursing homes’ first obligation should be to
                                      their residents, and every nursing home that participates in Medicare and Medicaid
                                      must meet Federal health and safety standards. If confirmed, it will be a top pri-
                                      ority for me to hold nursing homes accountable for providing high quality care to
                                      their residents. Thank you for your leadership on this critical issue.
                                        Question. Thorough and publicly available information on the health and safety
                                      of nursing homes is essential. I’ve worked closely with Senator Casey over the last
                                      year to push and prod CMS to collect and make public information about COVID–
                                      19’s impact on nursing homes that participate in Medicare and Medicaid. More re-
                                      cently, Senator Casey and I were joined by Ranking Member Crapo and Senator
                                      Scott (South Carolina) to request that CMS begin collecting and disseminating infor-
                                      mation regarding facility-level vaccination data. I was pleased to see CMS recently
                                      take some important steps toward improving transparency—such as requiring re-
                                      porting of staff vaccination rates—but there is more work to do. For example, the
                                      Finance Committee has repeatedly received testimony about the shortcomings of the
                                      Five Star System, which was created to provide clear and meaningful information
                                      on the quality of nursing homes. Unfortunately, in many cases a ‘‘five star’’ facility
                                      may not provide any better care or protection for residents than a one-star home.
                                      This system needs to be fundamentally rethought.
                                        Broadly speaking, if confirmed as CMS Administrator, will you support efforts to
                                      improve transparency relating to COVID–19 in nursing homes and address the dis-
                                      proportionate impacts of COVID–19 on nursing home residents of color?
                                        And specifically in regard to vaccinations, will you support efforts to provide con-
                                      sumers and Congress facility-level data about the rate of COVID–19 vaccinations in
                                      nursing homes?
                                        Answer. If I am fortunate enough to be confirmed, it will be a top priority for
                                      CMS to work to address the disproportionate impact of the COVID–19 pandemic on
                                      nursing home residents, especially those of color. I will also work to improve trans-
                                      parency, evaluation and accountability, including increasing the available data re-
                                      garding vaccinations in nursing homes.




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                                         Question. For years, press reports and academic research have repeatedly shown
                                      the negative impact that private-equity ownership of nursing homes takes on pa-
                                      tient care—an issue that has long been of interest to the Finance Committee. Most
                                      recently, a study published by the National Bureau of Economic Research found
                                      that private-equity ownership of nursing homes was associated with 10-percent
                                      higher short-term mortality of Medicare patients, was ‘‘accompanied by declines in
                                      other measures of patient well-being,’’ and led to 11-percent higher taxpayer spend-
                                      ing on a per-patient basis. Despite these issues, patients, families, and regulators
                                      are often hard-pressed to untangle when a nursing home is owned—or controlled
                                      through various subsidiaries—by a private equity firm. Section 6101 of the Afford-
                                      able Care Act sought to address the black box of nursing home ownership by setting
                                      out statutory requirements to increase the amount of information made available to
                                      the public. CMS issued a proposed rule to implement the statute in 2011, but with-
                                      drew it in 2012 after receiving comments. At the time, the agency signaled its inten-
                                      tion to reissue regulations that addressed the comments, but never did so.
                                         Does private equity’s growing role in the nursing home industry, and its impact
                                      on care quality, concern you?
                                         Do you plan to increase the transparency of nursing home ownership information,
                                      either through implementation of section 6101, or other regulatory requirements
                                      and guidance?
                                         Answer. Nursing homes’ first obligation should be to their residents, no matter
                                      what kind of ownership arrangements they have, and nursing homes participating
                                      in Medicare and Medicaid programs must meet required Federal health and safety
                                      standards. If confirmed, I am committed to working with you and your colleagues
                                      to ensure nursing homes provide high-quality care to their residents.
                                                                                   ----
                                                         QUESTIONS SUBMITTED BY HON. BENJAMIN L. CARDIN
                                                                           DXA REIMBURSEMENTS

                                        Question. Hip fracture is the most devastating fracture that someone with
                                      osteoporosis can experience. In Maryland, there has been an 18.5-percent decline in
                                      DXA testing of Medicare women since 2008, resulting in too many unnecessary and
                                      avoidable hip fracture related deaths each year.
                                        Will you commit to working with me and Senator Collins to improve access to
                                      osteoporosis testing by restoring adequate reimbursement for screenings in the phy-
                                      sician office?
                                        Answer. Thank you for bringing this issue to my attention. If confirmed, I am
                                      happy to work with you and Senator Collins to explore options to encourage osteo-
                                      porosis screenings.
                                                                               HOSPICE PAYMENTS

                                         Question. Hospices in Montgomery County, Maryland are at a long-term competi-
                                      tive disadvantage due to a Medicare hospice Federal payment inequity imposed in
                                      2006 by CMS involving the use of core-based statistical areas (CBSAs) when Metro-
                                      politan Divisions are present. Since CMS began using CBSAs to determine payment,
                                      hospices in Montgomery County have received lower payments than hospices in ad-
                                      jacent counties, or even those in more rural, low-cost parts of the tri-State area.
                                         Using CBSAs in this manner is flawed for the following reasons. Montgomery
                                      County has a similar cost of living compared to Washington, DC and shares the
                                      same labor market when competing for labor. As a result, hospices in Montgomery
                                      County are having difficulty providing the same level of services as hospices in DC,
                                      the three nearby Maryland counties, and the neighboring counties of Northern Vir-
                                      ginia, all of which are paid a higher reimbursement.
                                         I sought an administration solution to this issue in two delegation letters to CMS
                                      in 2017 and 2018 and hospices in Montgomery County have commented on this
                                      problem to CMS annually since 2005.
                                         In your role as CMS Administrator, will you commit to work to resolve this prob-
                                      lem?
                                         Answer. Thank you for raising this concern. I know you have been a leader in
                                      making sure Montgomery County, Maryland is treated fairly. I too want to make
                                      sure the Medicare program operates in an equitable and transparent way. If con-




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                                      firmed, I would be happy to work with you and others in the Maryland delegation
                                      on this issue to make sure your constituents have access to high quality hospice
                                      services.
                                                                                   ----
                                                           QUESTIONS SUBMITTED BY HON. SHERROD BROWN
                                                              MENTAL HEALTH SERVICES IN CHILD WELFARE

                                        Question. One of the ongoing challenges in child welfare is the greater need for
                                      mental health services including a greater supply of health professionals with
                                      knowledge and experience in child psychology. This is true in the need for post-
                                      adoption services as well as families we are trying to keep together.
                                        If confirmed, will you commit to working with States to improve coordination be-
                                      tween State child welfare agencies and State Medicaid departments to streamline
                                      services and supports for children and young people? How would you work to in-
                                      crease the supply of health professionals to better meet children and young people’s
                                      mental health needs?
                                        Answer. I share your commitment to making quality mental health services avail-
                                      able to children and families involved in the child welfare system, including families
                                      who adopt children from the child welfare system. If confirmed, I will make it a pri-
                                      ority for CMS to encourage better coordination between State Medicaid and child
                                      welfare agencies. The pandemic has created challenges for Americans’ mental
                                      health, especially for children, and increasing the number of providers is an impor-
                                      tant step to address these challenges. If I have the privilege of being confirmed, I
                                      also want to focus on improved coordination with other Agencies in HHS, including
                                      SAMHSA, to make sure we are better integrating mental and behavioral health into
                                      the health-care system.
                                                                               HCBS WORKFORCE

                                         Question. In order to strengthen Medicaid’s home and community-based services
                                      (HCBS), it is essential that we prioritize policies to develop, support, and build our
                                      Nation’s long-term care/HCBS workforce. We need to find ways to ensure higher
                                      wages for our home care workers and direct support professionals, and support their
                                      professional development.
                                         If confirmed, will you work with me and other members of Congress, the labor
                                      community, and other stakeholders on ways to provide more support for this essen-
                                      tial workforce?
                                         Answer. I appreciate your leadership in this area, and I understand we still have
                                      a ways to go to make HCBS a reality for seniors and individuals with disabilities
                                      in need of long-term care. Developing, supporting and building the workforce is key
                                      to ensuring access to these important services. If confirmed, I look forward to work-
                                      ing with you and our State partners to champion further progress to rebalance Med-
                                      icaid’s long-term care services and supports, including looking at what we can do
                                      together to help bolster the workforce.
                                                                          CONTINUOUS ELIGIBILITY

                                        Question. Each year, millions of Medicaid and CHIP beneficiaries who enroll in
                                      coverage are at risk of losing that coverage as a result of taking on an extra shift
                                      or working overtime, simply because their income fluctuates slightly. As a result,
                                      these short-term changes set in motion bureaucratic snafus that cause taxpayers to
                                      be disenrolled from their insurance. This breakdown in coverage often disrupts
                                      treatment plans and undermines the progress of their care, but can also cause sig-
                                      nificant administrative challenges that result in higher costs for States, providers,
                                      and health plans. This can be particularly disruptive for Medicaid beneficiaries
                                      using care coordination and care management services, which are interrupted every
                                      time a beneficiary is disenrolled.
                                        The Stabilize Medicaid and CHIP Coverage Act—legislation I’ve introduced with
                                      two other members of this committee, Senators Whitehouse and Warren—would
                                      ease the burden caused by churn by ensuring beneficiaries can depend on their cov-
                                      erage for a continuous 12-month period regardless of their age.
                                        Do you agree that we should work to minimize churn in health insurance cov-
                                      erage and eliminate disruptions in care that result when a beneficiary churns in
                                      and out of coverage?




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                                        If confirmed, will you work with me and my colleagues to strengthen the Medicaid
                                      and CHIP programs to minimize churn and ensure continued access to care for
                                      beneficiaries?
                                        Answer. I agree that reducing churn in health-care coverage is critical to ensuring
                                      continuity of care and positive health outcomes. I look forward to working with you
                                      on solutions to ensure that beneficiaries have continued access to health-care cov-
                                      erage they can rely on.
                                                              MEDICARE ADVANTAGE / PRIOR AUTHORIZATION

                                         Question. Thank you for your commitment to working with me to equal the play-
                                      ing field between traditional Medicare and the Medicare Advantage program. I look
                                      forward to collaborating on this effort.
                                         One area where we can create some parity lies in the prior authorization process.
                                      Last Congress, I introduced legislation with Senator Thune to establish an elec-
                                      tronic prior authorization program in Medicare Advantage (MA) to better facilitate
                                      the prior authorization process in MA and improve the timeliness and efficacy of
                                      care delivery for beneficiaries and their providers. CMS has issued a notice of pro-
                                      posed rulemaking to establish similar programs in Medicaid, the Children’s Health
                                      Insurance Program (CHIP), and insurers operating qualified health plans on the
                                      federally facilitated exchange under the Affordable Care Act (ACA). Beneficiaries
                                      and their providers should not have to jump through hoops in order to access medi-
                                      cally necessary services.
                                         If confirmed, will you work with Senator Thune and me to provide additional
                                      technical assistance on our legislation so that we can advance improved prior au-
                                      thorization processes that put the patient back at the center of care and reduce bar-
                                      rier to timely access to essential services?
                                         CMS has the legal authority to implement some of the provisions included in the
                                      Improving Seniors’ Timely Access to Care Act. As Administrator, will you consider
                                      regulatory action to move forward with the provisions of this legislation that are
                                      within your current authority to implement?
                                         Answer. I believe that ensuring Americans have timely access to health care is
                                      critical, and I agree with you that both providers and beneficiaries should not have
                                      to jump through unnecessary hoops for access to medically appropriate care. If con-
                                      firmed, I look forward to working with you, Senator Thune, and other members of
                                      Congress on these important issues.
                                                                               NURSING SCHOOLS

                                        Question. 42 U.S.C. 1395ww(l) provides an important source of support for
                                      hospital-based nursing schools across the country. Unfortunately, nearly a decade
                                      ago mistakes in the implementation of 42 U.S.C. 1395ww(l) resulted in several hun-
                                      dred million dollars of CMS overpayments. After becoming aware of these prior
                                      overpayments, CMS issued Transmittal 10315, requiring the recoupment of funds
                                      from hospitals to correct for past program overpayments.
                                        Unfortunately, this has resulted in a situation where hospital-based nursing
                                      schools in Ohio and across the country, due to no fault of their own, are required
                                      to pay back millions in funds that CMS mistakenly sent out in past years. While
                                      this claw-back of funding would be hard for hospital-based nursing schools to endure
                                      during normal times, this recoupment effort during the middle of a global pandemic
                                      that has decimated hospital revenues and highlighted the importance of our nursing
                                      workforce is both impossible and ironic.
                                        I have shared draft legislation with CMS that could help provide relief to these
                                      hospital-based nursing schools for the agency’s technical assistance. If confirmed,
                                      will you help expedite the process for agency feedback on this proposed fix and work
                                      with me and my colleagues on a solution that will support our hospital-based nurs-
                                      ing schools and their students?
                                        Answer. I am committed to supporting hospital-based nursing schools training the
                                      Nation’s next generation of practitioners. If I am fortunate enough to be confirmed,
                                      I will look into this important issue and look forward to working with you.
                                                               DIRECT AND INDIRECT REMUNERATION FEES

                                         Question. Community pharmacists are a critical player in our Nation’s health-care
                                      workforce, extending essential services to underserved and disproportionately at-
                                      risk communities. Especially during the COVID–19 pandemic, pharmacists have




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                                      been critical in our efforts to expand access to testing and vaccination services, in-
                                      cluding long-term care residents and other seniors and Part D beneficiaries.
                                        Unfortunately, the rapid growth of pharmacy direct and indirect remuneration
                                      (DIR) fees continues to create uncertainty for the community pharmacies Ohioans
                                      rely on for essential services. The use of DIR fees in Medicare Part D has exploded
                                      over the past several years, threatening the financial viability of pharmacies across
                                      Ohio and the health of the patients they serve. The Centers for Medicare and Med-
                                      icaid Services (CMS) has estimated that pharmacy DIR fee reform could result in
                                      saving Medicare beneficiaries between $7.1 and $9.2 billion in cost sharing burden
                                      over the next decade.
                                        If confirmed, will you commit to working with Congress on solutions to address
                                      the explosion of DIR fees and support stability for community pharmacies, while en-
                                      suring quality and low costs for Medicare beneficiaries?
                                        Answer. Small and rural pharmacies are critical to our Nation’s health-care sys-
                                      tem and have been especially important during the pandemic. It can be hard for
                                      these pharmacies to predict retroactive DIR fees. We must do all we can to ensure
                                      that Americans can access important health-care services, including from local phar-
                                      macies in their communities. If confirmed, I look forward to working with Congress
                                      to ensure that community pharmacists have predictability and to lower drug prices
                                      for patients and families.
                                                                     SOCIAL DETERMINANTS OF HEALTH

                                         Question. As was discussed during Thursday’s hearing, entities across the health-
                                      care and political spectrum are increasingly focused on ways to address the social
                                      determinants of health. The Centers for Medicare and Medicaid Services (CMS)—
                                      as both a payer and a policy driver—has many tools at its disposal to improve
                                      health and drive value by addressing social determinants.
                                         If confirmed, how will you use Federal payment policy—across Medicare and Med-
                                      icaid and through the Center for Medicare and Medicaid Innovation (CMMI)—to ad-
                                      dress the social determinants of health, ensure our Federal programs and models
                                      address health-related social needs of patients, and support upstream investments
                                      in the social determinants of health?
                                         Answer. The COVID–19 pandemic has further exposed the disparities that exist
                                      in our society. I understand the CMS Innovation Center is currently testing the Ac-
                                      countable Health Communities Model, which evaluates whether systematically iden-
                                      tifying and addressing the health-related social needs of Medicare and Medicaid
                                      beneficiaries through screening, referral, and community navigation services will
                                      impact health-care costs and reduce health-care utilization. In addition, if con-
                                      firmed, I intend to take a department-wide approach to the advancement of equity,
                                      consistent with President Biden’s charge to Federal departments and agencies, and
                                      this would include examination of ways to address the social determinants of health.
                                                               REIMBURSEMENTS FOR NEW TECHNOLOGIES

                                        Question. In January 2021, HHS released its Artificial Intelligence (AI) strategy,
                                      which reads, in part: together with its partners in academia, industry, and govern-
                                      ment, HHS will leverage AI to solve previously unsolvable problems by continuing
                                      to lead advances in the health and well-being of the American people, responding
                                      to the use of AI across the health and human services ecosystem, and scaling trust-
                                      worthy AI adoption across the Department.
                                        While the growth of technology in health care has the potential to facilitate access
                                      to care and improve quality for beneficiaries, it is critical that any strategy to incor-
                                      porate AI in HHS policy center consumers. As the Department works to leverage
                                      AI and incorporate AI applications and other advanced technologies across health
                                      care, HHS should use all existing tools, including payment systems, to support the
                                      adoption of technology that increases access to and quality of care.
                                        CMS payment policy has lagged behind when it comes to coverage of newer tech-
                                      nologies that offer more personalized approaches to diagnosis and treatment, includ-
                                      ing those that utilize a form of AI. If confirmed, will you commit to reviewing CMS
                                      payment policies for disparities in coverage of AI and other new technologies and
                                      acting to update payment systems, where appropriate, to ensure access to those
                                      technologies that improve access to and quality of care?
                                        Answer. Thank you for raising this important issue. It is incredible what scientific
                                      progress has been made with innovative drugs and treatments, and we need to con-




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                                      tinue to modernize the Medicare and Medicaid programs to make sure beneficiaries
                                      have access to proven new treatments. I understand that in 2019, CMS launched
                                      the AI Health Outcomes Challenge, to engage with innovators with harness AI solu-
                                      tions to predict health outcomes for potential use in CMS Innovation Center innova-
                                      tive payment and service delivery models. If confirmed, I commit to continuing to
                                      review how CMS can harness new technologies that utilize AI to improve health
                                      outcomes for beneficiaries.
                                                                                   ----

                                                          QUESTION SUBMITTED BY HON. ROBERT P. CASEY, JR.
                                        Question. The COVID–19 pandemic has underscored the urgent need to enhance
                                      quality in our Nation’s nursing homes. The profound loss of life we have experienced
                                      over the last year is a tragedy within the broader tragedy of this pandemic. More
                                      than 182,000 residents and workers have died of COVID–19 in nursing homes and
                                      other long-term care facilities. Well before the pandemic, I worked alongside Senator
                                      Toomey to shed light on cases of abuse and neglect in underperforming nursing
                                      homes. These nursing homes are part of what’s known as the Special Focus Facility
                                      program.
                                        My 2019 investigation with Senator Toomey found that this subset of nursing
                                      homes consistently fails to provide quality care, and yet not every nursing home
                                      that needs it is receiving intervention. We have an obligation to use every tool avail-
                                      able to ensure that the residents who live in these homes receive the highest stand-
                                      ard of care.
                                        That is why, last month, Senator Toomey and I reintroduced our bill, the Nursing
                                      Home Reform Modernization Act (S. 782). Together, we have laid out a bipartisan
                                      path forward to strengthen, target and expand oversight and give help and assist-
                                      ance to nursing homes that need it.
                                        Ms. Brooks-LaSure, can I count on you to prioritize making improvements to
                                      nursing home quality and to work with me and Senator Toomey to identify how to
                                      enhance oversight for the poorest performing facilities?
                                        Answer. It has been heartbreaking to see how hard the COVID–19 pandemic has
                                      hit the Nation’s nursing homes, and this is not an issue newly created by the pan-
                                      demic, as you noted. I agree that nursing homes must provide high-quality care to
                                      their residents. Nursing homes’ first obligation should be to their residents, and
                                      every nursing home that participates in Medicare and Medicaid must meet Federal
                                      health and safety standards. If confirmed, it will be a top priority for me to hold
                                      nursing homes accountable for providing high quality of care to their residents.

                                        Thank you for your leadership on this critical issue. I know this has been a pri-
                                      ority of yours, and I would be happy to work with you and Senator Toomey on this
                                      issue if I am fortunate enough to be confirmed.

                                                           QUESTIONS SUBMITTED BY HON. MARK R. WARNER
                                         Question. The PACE (Program of All-Inclusive Care for the Elderly) was estab-
                                      lished by Federal statute to provide the full range of Medicare and Medicaid bene-
                                      fits to seniors who want to remain safely in their homes, rather than enter a nurs-
                                      ing home setting. The COVID–19 pandemic bolstered the attractiveness of the
                                      PACE program as these programs were able to pivot from providing services in
                                      PACE centers toward doing more telehealth and in-home visits, showing that PACE
                                      can help maintain seniors’ well-being when it is dangerous for them to be in group
                                      settings.
                                         We have a number of large and successful PACE programs across Virginia. I have
                                      always been a fan of PACE, and Virginia is one of the more active and supportive
                                      States for PACE. PACE does have a big runway for growth, considering that more
                                      than two million people in the United States qualify for PACE, but only about
                                      55,000 individuals are currently enrolled.
                                         How do you feel about PACE? Do you have a plan for promoting more PACE cen-
                                      ters in the States?
                                         Answer. PACE is an important option that helps individuals in need of nursing
                                      home-level care to get health care at home or in community-based settings. PACE
                                      provides Medicare and Medicaid services under a model of care that includes com-
                                      prehensive care management. More can be done to encourage the kind of care co-




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                                      ordination and alternative to institutional care seen in PACE. If I am fortunate
                                      enough to be confirmed, I will look forward to working with you on this important
                                      issue.
                                         Question. The American Federation of Government Employees (AFGE) Local
                                      1923, the union that represents employees at the Centers for Medicare and Med-
                                      icaid Services (CMS), has expressed concerns to my office about unfair labor prac-
                                      tices enacted by the previous administration. Specifically, these dedicated public
                                      servants have expressed concern they were forced to accept an unfair collective bar-
                                      gaining agreement (CBA) due to the Trump administration’s executive orders (EOs)
                                      of 2018 and the Federal Services Impasses Panel (FSIP).
                                         If confirmed, will you commit to reexamining this collective bargaining agreement
                                      (CBA) to ensure it is fair to the dedicated public servants you will oversee?
                                         Will you also ensure that CMS engages in good faith negotiations with AFGE and
                                      that the agency and its managers appropriately implement EO 14003?
                                         Answer. Thank you for raising this important issue. Our workforce is critical to
                                      the continued success of CMS’s programs. If I am so fortunate to be confirmed, I
                                      would like to learn more about the issues that have been raised to your office, and
                                      I will look into this issue to make sure CMS employees have the protections they
                                      deserve.
                                                                                   ----
                                                        QUESTIONS SUBMITTED BY HON. SHELDON WHITEHOUSE
                                                                         ELEANOR SLATER HOSPITAL

                                         Question. The Rhode Island Department of Behavioral Health, Developmental
                                      Disabilities and Hospitals stopped billing CMS for Medicaid claims in 2019 following
                                      a State audit that flagged the need for some technical fixes to the Rhode Island
                                      Medicaid State Plan. CMS recently approved an amendment to the State Plan, but
                                      the suspension of billing may amount to approximately $60 million of lost Medicaid
                                      dollars for my State. I have contacted CMS with number of questions regarding the
                                      suspension and the possibility of the State recouping some of the $60 million. Will
                                      you commit to providing me with detailed information regarding the billing suspen-
                                      sion at Eleanor Slater Memorial Hospital and to working with me to recoup some
                                      of the funding that was lost?
                                         Answer. If confirmed, I would be happy to work with you on this issue. Respon-
                                      siveness and communication with Congress will be a key priority for me, as I under-
                                      stand your important role in helping your constituents.
                                                                   IMPUTED RURAL FLOOR IMPLEMENTATION

                                        Question. As part of the American Rescue Plan, I championed a legislative fix to
                                      restore the imputed rural floor for Medicare hospital reimbursement rates. CMS is
                                      responsible for implementing the legislative fix and should include the imputed
                                      rural floor in the FY22 Inpatient Prospective Payment System rule. Do you commit
                                      to restoring the imputed rural floor in the forthcoming IPPS rule?
                                        Answer. Thank you for your leadership on this issue. I want to make sure we op-
                                      erate the Medicare program in an equitable and transparent way. I know you
                                      worked very hard to make sure this was addressed in the American Rescue Plan
                                      Act, and I have every reason to anticipate that CMS is working hard to ensure that
                                      the provision will be implemented as quickly as possible. I would be very happy to
                                      stay in touch with you, if confirmed, on CMS’s implementation of this provision.
                                                                                   MEDICAID

                                        Question. Rhode Island’s Medicaid 1115 waiver will expire on December 31, 2023.
                                      The current 1115 waiver focuses on social determinants of health, long-term services
                                      and support rebalancing and alternative payment methodologies. How will CMS
                                      work with the State when it is time to renew the 1115 waiver?
                                        Answer. Medicaid is an important lifeline for many American families. Section
                                      1115 demonstration projects, or waivers, are one available tool to States to help test
                                      new and innovative policies in Medicaid. I have worked closely with States through-
                                      out my career, so I know they face different challenges and need consistency and
                                      predictability. If confirmed, I will keep in mind what I have learned working on be-
                                      half of States to make sure waiver requests are appropriately evaluated while giving
                                      them consistent guidance. I will support State innovation and the ability of States




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                                      to test out different models that meet the objectives of the Medicaid program. I look
                                      forward to seeing the ideas States bring to the table and will consider each one on
                                      its merits.
                                         Question. Rhode Island is committed to alternative payment methodologies, in-
                                      cluding Medicaid accountable care organizations but the Federal funding for this
                                      program is time-limited. What additional funding, policy support or technical assist-
                                      ance will CMS provide to advance alternative payment methodologies?
                                         Answer. Alternative payment methodologies and delivery reform, generally, are so
                                      important to moving our health-care system towards one that rewards value over
                                      volume. States, like Rhode Island, are often the leading innovators in this effort,
                                      and we should be learning from their successes. More integrated and coordinated
                                      care can help to improve care and lower costs. If confirmed, I want to work with
                                      you to make sure we are pursuing demonstration projects that achieve these goals,
                                      and I would be happy to work with you to support States’ efforts to innovate in their
                                      Medicaid programs.
                                                                                  HEALTH IT

                                         Question. CMS played a leading role in supporting significant HIT infrastructure
                                      under the HITECH Act. What resources does CMS need in order to fund new invest-
                                      ments in HIT infrastructure that are compliant with interoperability standards?
                                         Answer. Interoperability of patient records is so critical to ensure appropriate co-
                                      ordination of care. We need to improve health information technology across our
                                      health-care system, particularly for behavioral health providers—an important issue
                                      I know you have worked to address. I look forward to working with you on this
                                      issue, including determining what additional resources might be needed, if con-
                                      firmed.
                                                                           AFFORDABLE CARE ACT

                                        Question. How will CMS work with States like Rhode Island that fully embraced
                                      the ACA to reduce the remaining barriers to universal coverage?
                                        Answer. If I am fortunate enough to be confirmed, it will be a priority of mine
                                      to build on the successes of the Affordable Care Act (ACA). The ACA has extended
                                      coverage for millions of American families. It is so important that American patients
                                      and families be able to afford health insurance, and I appreciate Congress’s leader-
                                      ship in taking action through the American Rescue Plan Act to bring down pre-
                                      miums during the pandemic. We need to continue to work on this issue to make
                                      health care more affordable. This includes working with States, like Rhode Island,
                                      that have been leaders in ACA implementation to learn from their successes and
                                      continue to move the ball forward.
                                                                                   ----
                                                        QUESTIONS SUBMITTED BY HON. CATHERINE CORTEZ MASTO
                                         Question. A noteworthy pattern over the course of the pandemic has been the high
                                      utilization of telehealth services via telephone, without any video. This flexibility
                                      has allowed physicians to keep their doors open and continue treating patients, and
                                      vulnerable individuals who don’t have access to a smart phone or might struggle
                                      with technology are able to seek services.
                                         In your view, is it important that we maintain access to these services for both
                                      Medicare and Medicaid beneficiaries who are still unable to utilize in-person care?
                                         Answer. Telehealth has been invaluable during this pandemic to keep patients,
                                      their providers and their families safe. My brother is a psychologist, and telehealth
                                      has really helped his patients get the care they need. If I am fortunate enough to
                                      be confirmed, I will be taking a careful look at the telehealth flexibilities under
                                      Medicaid and Medicare before the Public Health Emergency ends. During that re-
                                      view, I will pay special attention to the issues of equity and access. I will look at
                                      what we can and should extend administratively and where we will need Congress’s
                                      help to ensure that we bring the lessons learned about telehealth during the pan-
                                      demic forward to modernize our health-care system.
                                         Question. Medicare Advantage plans serve more than 26 million vulnerable bene-
                                      ficiaries who have similarly benefited from this expansion in telehealth services. I’m
                                      concerned that current CMS risk adjustment policies that exclude audio-only diag-
                                      noses could hamper MA’s ability to serve beneficiaries during this crucial period and




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                                      negatively impact the program, its provider partners, and MA enrollees in the fu-
                                      ture.
                                        Will you further commit to reviewing this policy promptly to ensure that the pol-
                                      icy does not negatively impact premiums, benefits, out-of-pocket costs, or the avail-
                                      ability of plans in 2022?
                                        Answer. Medicare Advantage serves millions of Americans and is an important
                                      option for Medicare beneficiaries. During the pandemic, we have been able to see
                                      the value telehealth brings for patients, including those enrolled in Medicare Advan-
                                      tage. If confirmed, I look forward to working with you to ensure that beneficiaries
                                      enrolled in Medicare Advantage plans can continue to benefit from these services.
                                                                                   ----

                                                          QUESTIONS SUBMITTED BY HON. ELIZABETH WARREN
                                                                        UNIQUE DEVICE IDENTIFIERS

                                         Question. Although medical device failures are rare, when they do occur, they can
                                      create serious health problems and significant financial costs. A 2017 investigation
                                      by the Office of Inspector General at the Department of Health and Human Services
                                      found that recalls or premature failures of just seven faulty cardiac devices resulted
                                      in $1.5 billion in Medicare payments and $140 million in out-of-pocket costs to bene-
                                      ficiaries. Furthermore, the Inspector General was not able to examine the total cost
                                      of all device failures because of the lack of information about specific devices in
                                      claims data. Instead, OIG examiners were forced to engage in a ‘‘complex and labor-
                                      intensive audit’’ to assess the impact of the seven faulty devices. As a result, the
                                      OIG recommended that CMS add unique device identifiers (UDIs) to Medicare
                                      claims. Including device identifiers on claims transactions would greatly improve
                                      the health system’s ability to identify risks and reach patients who may be affected
                                      by device failures.
                                         The process of adding UDIs to Medicare claims is a complex one, but ultimately
                                      will require CMS to agree to act on the recommendations of X12, an entity that es-
                                      tablishes accredited standards for claims transactions. X12 recently recommended
                                      that the device identifier portion of a medical device’s UDI be included on the elec-
                                      tronic claims transaction. As the Administrator of CMS, will you commit to imple-
                                      menting X12’s recommendation and adding UDIs to Medicare claims?
                                         Answer. Thank you for your bipartisan leadership on this issue. I understand that
                                      a revised claims form that includes the device identifier has made it through the
                                      first step in the consensus- based process and that the next step is for the National
                                      Committee on Vital and Health Statistics to make recommendations. If I am fortu-
                                      nate enough to be confirmed, I would be happy to look into this issue further and
                                      to stay in touch about it with you.
                                                                      ELECTRONIC VISIT VERIFICATION

                                         Question. The 21st Century Cures Act of 2016 included a requirement that States
                                      implement electronic visit verification (EVV) systems for certain Medicaid services.
                                      EVV systems are designed to certify that personal care services and home health
                                      services in Medicaid are actually provided. They must verify the type of service pro-
                                      vided, the date of service, the location of the service, the time the service begins
                                      and ends, and the identities of the patient and provider. States that fail to imple-
                                      ment EVV programs are subject to a 1 percent, incremental FMAP reduction unless
                                      they can demonstrate that a ‘‘good faith effort’’ has been made to comply. States
                                      were required to begin implementing EVV for personal care services in January
                                      2020, and they must begin doing so for home health services in January 2023.
                                         Since the 21st Century Cures Act was passed, advocates for workers, people with
                                      disabilities, older adults, and Medicaid patients have expressed concern about the
                                      lack of worker and patient privacy protections in EVV programs. Meanwhile, they
                                      have expressed concern about the possibility of States losing Medicaid funding in
                                      the midst of the COVID–19 pandemic. As the Administrator of CMS, will you com-
                                      mit to reviewing existing Federal EVV guidance to determine (1) whether worker
                                      and service recipient civil rights are adequately protected, particularly with regard
                                      to the use of biometric and GPS data and (2) whether existing EVV guidance con-
                                      tributes to workforce shortages, and what improvements could made to the guidance
                                      to mitigate those shortages? Will you commit to ensuring that States do not lose
                                      funding for critical services via an FMAP decrease during the COVID–19 pandemic?
                                      Will you commit to improving existing Federal EVV guidance and considering the




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                                      possibility of using the rulemaking process to ensure that worker and service recipi-
                                      ent privacy and other rights are protected in EVV programs?
                                        Answer. Protecting the privacy of patients and our health-care workforce is criti-
                                      cally important. If confirmed, I will fully examine these issues to determine the ad-
                                      ministrative or legislative actions that would be needed to make sure that these re-
                                      quirements are protecting privacy and not placing an undue burden on States and
                                      health-care workers.

                                                                                    ----
                                                              QUESTIONS SUBMITTED BY HON. MIKE CRAPO
                                                                     MEDICARE /MEDICARE ADVANTAGE

                                         Question. During the COVID–19 pandemic, CMS provided Medicare Advantage
                                      (MA) plans with additional flexibilities, such as expanding telehealth services, pro-
                                      viding beneficiaries with devices to use telehealth and remote patient monitoring,
                                      and reducing cost sharing and premiums. How would you work with stakeholders
                                      and Congress to continue certain enhanced benefits and flexibilities, which could
                                      continue to further the MA program?
                                         Answer. Medicare Advantage serves millions of Americans and its enhanced bene-
                                      fits and plan flexibilities provide important options for beneficiaries who choose to
                                      enroll in it. I believe we have to take every approach we can in order to get people
                                      the health care they need at an affordable price, including through the appropriate
                                      use of telehealth services. Telehealth has been invaluable during this pandemic in
                                      helping to keep patients, their providers and their families safe. I want to be sure
                                      we take in the lessons from this pandemic, including the value of telehealth, and
                                      look at what flexibilities we can and should extend administratively, and where we
                                      may need to work with Congress. If confirmed as CMS Administrator, I look for-
                                      ward to working with you to achieve this important goal.
                                                                               MEDICARE SOLVENCY

                                         Question. Medicare is on a near-term path toward bankruptcy. The HI trust fund
                                      could be insolvent in anywhere from 4 to 5 years. Other than during the first few
                                      years of the Medicare program’s existence, Congress has never allowed the HI trust
                                      fund to project less than 4 years of solvency without acting in order to minimize
                                      the impact on health-care providers, taxpayers, and beneficiaries. Given the looming
                                      fiscal crisis, how soon can we expect a comprehensive legislative proposal from HHS
                                      that extends the life of the HI trust fund?
                                         Answer. Medicare solvency is an incredibly important, longstanding issue. I look
                                      forward to working with Congress on a bipartisan basis to address this. We will
                                      need both short-term and long-term strategies to make sure Medicare remains a
                                      bedrock of our health-care system. It is essential that we protect this program for
                                      Americans who have spent their lives paying into it.
                                                                                  DRUG PRICES

                                         Question. There is broad concern that establishing Medicare (or other) prescrip-
                                      tion drug payment amounts using foreign reference prices will harm patient access
                                      and stifle innovation. Do you support the use of foreign reference prices in Medi-
                                      care? Do you view the use of a foreign reference price to set payment amounts as
                                      price setting or a form of negotiation?
                                         Answer. We all agree that too many Americans cannot afford their prescription
                                      drugs. Lowering prescription drug costs for American patients and families is a pri-
                                      ority on both sides of the aisle, as is ensuring that the United States continues to
                                      allow for innovation in drug development. I want to work with you and other mem-
                                      bers of Congress to find ways to ensure patients have access to innovative drugs
                                      and bring down prescription drug prices.
                                                                                      CMMI

                                        Question. The Affordable Care Act established the Center for Medicare and Med-
                                      icaid Innovation (CMMI). There is significant bipartisan support for testing different
                                      ways to pay for services to figure out how patients can get better care at a lower
                                      cost. However, there is concern that Congress ceded too much authority to the exec-
                                      utive branch by allowing CMMI to override statute, especially in Medicare, in the
                                      name of a payment change ‘‘test.’’




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                                         What are your views on the appropriate use of CMMI authority?
                                         If confirmed, will you commit to ensuring that CMS would not use CMMI to avoid
                                      working with Congress?
                                         Considering that many CMMI tests have run for an extended period of time with-
                                      out meeting the criteria for expansion, is there a length of time sufficient to deter-
                                      mine if a model works?
                                         With CMMI having a large budget of $10 billion for each decade and little ac-
                                      countability to Congress, what metrics would you use to determine whether CMMI
                                      is successful?
                                         Answer. The Innovation Center has been an important tool to test new models
                                      to move our system from one that rewards volume to one that rewards value. It will
                                      continue to be important, as we move forward, to test models that improve patient
                                      care, advance health equity, and lower patient costs. We have now had 10 years of
                                      experience to learn from at the Innovation Center. We need to look at what has
                                      worked and what hasn’t, and I look forward to hearing from you about what you
                                      think is working well and what experiences you’ve seen in Idaho.
                                                                                  PAYMENTS

                                         Question. There are concerns that the inclusion of calcimimetic medications in the
                                      Medicare End Stage Renal Disease (ESRD) bundled payment rate may harm bene-
                                      ficiaries’ access to these treatments. There are anecdotal reports that some patients
                                      have had to change or otherwise stop using a medicine that has worked for them
                                      in response to this payment policy change. How would you ensure that ESRD pa-
                                      tients have access to calcimimetic treatments and monitor patient outcomes in this
                                      area?
                                         Answer. I agree that is it important for Medicare beneficiaries, particularly pa-
                                      tients with complex medical conditions such as ESRD, to have access to medically
                                      necessary treatments such as calcimimetics. If confirmed, I will work to preserve ac-
                                      cess to critical treatments and improve patient outcomes.
                                         Question. In the ‘‘Medicare Hospital Outpatient Prospective Payment and Ambu-
                                      latory Surgical Center Payment Systems’’ proposed rule for 2021, CMS solicited
                                      comments on the use of its ‘‘equitable adjustment’’ authority for pass-through prod-
                                      ucts adversely impacted by the reduction in surgical procedures during the COVID–
                                      19 pandemic. Will CMS use this authority to ensure that products impacted by the
                                      pandemic receive pass-through payments for a length of time that enables adequate
                                      cost data collection that ensures reasonable payment once these products are bun-
                                      dled into an ambulatory payment classification (APC) group?
                                         Answer. The COVID pandemic is taking a toll on Americans in so many ways,
                                      including reducing and delaying surgeries. If confirmed, I will work with you and
                                      other members of Congress as we look for ways to help providers, suppliers, and
                                      other stakeholders recover from the financial impacts of the pandemic and maintain
                                      access for beneficiaries.
                                                                               NEW TREATMENTS

                                        Question. The 21st Century Cures Act that was enacted in 2016 created a home
                                      infusion therapy benefit to provide for the nursing services necessary to support
                                      drug administration in the home setting when patients are unable to self-
                                      administer. To date, no new drugs requiring health-care professional administration
                                      have been able to get covered for home infusion. CMS issued a ‘‘Durable Medical
                                      Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Policy Issues and Level
                                      II of the Healthcare Common Procedure Coding System (HCPCS)’’ proposed rule in
                                      2020 that would create a pathway for drugs requiring healthcare professional ad-
                                      ministration to be covered for home infusion. This rule has not yet been finalized,
                                      even though many seniors would continue to benefit from being able to receive
                                      treatment at home during the COVID–19 pandemic. Will CMS prioritize the final-
                                      ization of this DMEPOS proposed rule to expand seniors’ access to the home infu-
                                      sion benefits?
                                        Answer. Thank you for raising this important issue. We share the goal of making
                                      sure people can receive care in their homes, when appropriate, especially during the
                                      pandemic. If confirmed, I am happy to make the review of this proposed rule a pri-
                                      ority.
                                        Question. Cell and gene therapies present a paradigm shift in the treatment of
                                      disease, no longer just treating symptoms, but using cutting-edge technology to ad-




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                                      dress the root cause of the disease itself. The FDA has previously predicted that it
                                      will be approving 10 to 20 cell and gene therapies a year by 2025. Many of the ini-
                                      tial diseases that these groundbreaking therapies aim to treat are disproportion-
                                      ately insured by Medicare and Medicaid. The cost of these potentially life-saving
                                      therapies has led to a national conversation on the use of value-based arrangements
                                      to ensure broader access for beneficiaries, especially for rare disease and cancer pa-
                                      tients where the population that is eligible for the therapy could be in the hundreds
                                      or thousands.
                                         Would you agree that CMS should do all they can to ensure access to FDA-
                                      approved cell and gene therapies when a doctor and a patient agree it is the best
                                      treatment option?
                                         As Administrator, would you commit to utilizing existing program flexibility and
                                      considering innovative demonstration programs to enable Medicare and Medicaid
                                      beneficiaries’ timely access to innovative cell and gene therapies? Will you commit
                                      to working with Congress on a statutory solution that maximizes access without
                                      threatening future development of these innovative products?
                                         Answer. Thank you for raising this important issue. It is incredible what scientific
                                      progress has been made with innovative drugs and treatments, and we need to con-
                                      tinue to modernize the Medicare and Medicaid programs to make sure beneficiaries
                                      have access to proven new treatments. I would be happy to work with you and other
                                      members of Congress on ways to spur innovation and facilitate beneficiary access
                                      to proven new advances in medicine.
                                                                                   ----

                                                           QUESTIONS SUBMITTED BY HON. CHUCK GRASSLEY
                                         Question. American taxpayers expect us to be good stewards of Federal money.
                                      Under section 1903(u) of the Social Security Act, the Federal Government is re-
                                      quired to recoup any improper Medicaid eligibility-related payments in excess of
                                      three percent made by States. The Centers for Medicare and Medicaid Services
                                      (CMS) has made little improvement since 1992 to recover any of these payments.
                                      In 2019, Congress passed the Payment Integrity Information Act requiring CMS to
                                      periodically review programs it administers, identify programs that may be suscep-
                                      tible to significant improper payments, estimate the amount of improper payments,
                                      and report on the improper payment estimates. The most recent annual reported
                                      improper payments figure across all Medicare and Medicaid/CHIP programs was
                                      $134.21 billion (2020 CMS estimated data) and $106 billion (2019 CMS data). The
                                      Medicaid improper payment rate for 2020 was 21.36 percent (or $84.49 billion) and
                                      the Medicare fee-for-service improper payment rate for 2020 was 6.27 percent (or
                                      $25.74). This has been ongoing for decades. If confirmed, how will you as CMS ad-
                                      ministrator address the improper payment rate and the waste of taxpayer dollars?
                                         Answer. Medicaid is a critical lifeline for beneficiaries across the country and typi-
                                      cally the largest expenditure for States. Reducing Medicaid improper payments is
                                      a priority because it helps ensure the fiscal health of the program. If confirmed, I
                                      will work with States and leaders in Congress to be responsible stewards of tax-
                                      payer dollars across both Medicaid and Medicare.
                                         Question. Ensuring access and protections for individuals with serious disabilities
                                      who rely on complex rehabilitative manual wheelchairs is important. In 2019, Con-
                                      gress provided 18-month relief for complex rehab technology (CRT) by including pro-
                                      tections for complex rehab manual wheelchairs. On June 30, 2021, a temporary pol-
                                      icy allowing users of complex rehabilitative manual wheelchairs the same benefits
                                      as complex rehabilitative power wheelchair users will expire. This policy has given
                                      equal access for the people with disabilities who depend on this new technology. If
                                      confirmed, would you support a permanent policy maintaining the equal access be-
                                      tween manual and power wheelchairs?
                                         Answer. I agree that is important to make sure Medicare beneficiaries have access
                                      to the durable medical equipment they need. If confirmed, I will work with you on
                                      this issue.
                                         Question. In 2020, I cosponsored the Temporary Reauthorization and Study of the
                                      Emergency Scheduling of Fentanyl Analogues Act and it was signed into law. The
                                      law extended the Drug Enforcement Administration’s temporary scheduling order to
                                      proactively control deadly fentanyl analogues. Fentanyl-related overdose deaths con-
                                      tinue to rise and sophisticated drug trafficking organizations manipulate dangerous
                                      substances to skirt the law, so this critical law placed fentanyl substances in Sched-




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                                      ule I so that they can be better detected and criminals can be held accountable for
                                      their actions. The law sunsets in May of 2021. In December 2019, 56 other State
                                      and territory attorneys general asked Congress to permanently codify a temporary
                                      emergency scheduling order keeping fentanyl-related substances classified as Sched-
                                      ule I drugs. If confirmed, do you support permanently codifying a temporary emer-
                                      gency scheduling order keeping fentanyl-related substances classified as Schedule I
                                      drugs?
                                         Answer. I recognize that fentanyl and fentanyl analogues pose a significant dan-
                                      ger and are responsible for far too many deaths every year. While CMS does not
                                      have a role in the scheduling process, I understand that HHS plays a key role that
                                      effort.
                                         Question. Science tells us that an unborn child has many of the neural connec-
                                      tions needed to feel pain, perhaps as early as eight weeks and most certainly by
                                      20 weeks fetal age. Providing health care to unborn children and their mothers can
                                      help reduce infant mortality rates in low-income communities, research also sug-
                                      gests. Some States already offer prenatal care and other health services to unborn
                                      children through the Medicaid program. What is your view on whether unborn chil-
                                      dren should be entitled to Medicaid coverage, and do you believe that the Federal
                                      Government has a role to play in encouraging such coverage?
                                         Answer. Medicaid is an important source of pre- and post-natal care, and if I am
                                      confirmed, I will work to ensure that pregnant people have access to quality health
                                      care that improves their own health and the health of their babies. I was happy to
                                      see that Congress included incentives for States to expand Medicaid postpartum
                                      coverage in the American Rescue Plan and that CMS has approved section 1115
                                      demonstration projects to this effect. I look forward to working with members of this
                                      committee and Congress to expand access to affordable, quality care, including
                                      through the Medicaid program.
                                         Question. Congress’s ability to acquire information from Federal agencies is crit-
                                      ical to its constitutional responsibility of conducting oversight of the executive
                                      branch. If you are confirmed, will you commit to providing thorough, complete, and
                                      timely responses to requests for information from members of this committee, in-
                                      cluding requests from members of the minority?
                                         Answer. If confirmed, I will provide responses to requests from any members of
                                      this committee.
                                         Question. In 2019, Congress passed bipartisan the Advancing Care for Exceptional
                                      (ACE) Kids Act to improve health outcomes and care coordination for children with
                                      complex medical conditions in Medicaid. In 2020, I introduced the bipartisan Accel-
                                      erating Kids’ Access to Care Act to further help families gain access to life-saving
                                      care for children with complex medical conditions. The legislation aims to facilitate
                                      access to care while retaining program safeguards and reducing regulatory burdens
                                      on providers. If confirmed, what steps would you take to improve the system of care
                                      for children with complex medical conditions?
                                         Answer. Thank you for your leadership on the ACE Kids Act and your focus on
                                      access to care for children with complex medical needs. I agree that we should do
                                      all we can to remove barriers to care for these children. If I am fortunate enough
                                      to be confirmed, I will look forward to working with you on solutions to ensure chil-
                                      dren with complex medical needs get the best care possible.
                                         Question. In Iowa, transitional health plans (including grandmothered health
                                      plans) have enabled many middle class Iowans to keep the health plans and doctors
                                      they like at a reasonable price since the Affordable Care Act was implemented. For
                                      example, over 56,000 Iowans are covered by grandmothered health plans. To put
                                      this in context, about 60,000 Iowans signed up for the Federal health insurance ex-
                                      change in 2021. Iowans have chosen these grandmothered health plans that meet
                                      their individual needs. Currently, grandmothered health plans’ existence is deter-
                                      mined by the Department of Health and Human Services (HHS) through the Cen-
                                      ters for Medicare and Medicaid Services (CMS) annually through non-enforcement
                                      extensions. If confirmed, are you committed to maintaining these affordable,
                                      consumer-chosen health plan options for Iowans by extending the non-enforcement
                                      authority?
                                         Answer. Making sure that all Americans have access to quality, affordable health
                                      care is one of the Biden administration’s top priorities. If confirmed, I will examine
                                      rules and other policies to ensure all Americans can access the care that they need,
                                      and I look forward to learning more from you about what is working in Iowa.




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                                         Question. Since this COVID–19 pandemic began, the Department of Health and
                                      Human Services (HHS) including within the Centers for Medicare and Medicaid
                                      Services (CMS) has provided health-care providers and patients many flexibilities
                                      under the public health emergency authority including over 80 services now fur-
                                      nished through telehealth for Medicare patients. A Centers for Disease Control and
                                      Prevention (CDC) Morbidity and Mortality Weekly Report found the use of tele-
                                      health increased 154 percent during the last week of March 2020 during the emer-
                                      gency of COVID–19 compared to the same period in 2019. We know the use of tele-
                                      health has continued throughout the COVID–19 pandemic. The data and response
                                      from patients and providers prove permitting telehealth services is a positive action
                                      to improve access and care. This last Congress, we provided permanent coverage for
                                      mental health telehealth visits under Medicare, which is helpful during the pan-
                                      demic and will remain critical for many Americans afterwards. If confirmed, are you
                                      committed to working with Congress and in the executive branch to extend tele-
                                      health flexibilities in Medicare beyond the pandemic? Additionally, some providers,
                                      including community health centers, face regulatory barriers based on provider type
                                      or site of service. If confirmed, do you support removing those telehealth barriers
                                      for certain providers?
                                         Answer. Telehealth has been invaluable during this pandemic to keep patients,
                                      their providers and their families safe. My brother is a psychologist, and telehealth
                                      has really helped his patients get the care they need. If I am fortunate enough to
                                      be confirmed, I will take a careful look at the telehealth flexibilities under Medicaid
                                      and Medicare before the Public Health Emergency ends. During that review, I will
                                      pay special attention to the issues of equity and access. I will look at what we can
                                      and should extend administratively and where we will need Congress’s help to en-
                                      sure that we bring the lessons learned about telehealth during the pandemic for-
                                      ward to modernize our health-care system.
                                         Question. As a direct result of the Affordable Care Act’s one-size-fits-all approach,
                                      many Iowans have been priced out of health insurance. To rectify this, the Trump
                                      administration and Iowa Insurance Division enabled Iowans more choice and com-
                                      petition in the health-care marketplace by enabling and expanding short-term
                                      limited-duration insurance (STLDI). This gives Iowans access to health insurance
                                      with consumer protections. If confirmed, will you work to maintain, modify, or re-
                                      scind the current regulations enabling Americans to purchase STLDIs?
                                         Answer. Making sure that all Americans have access to quality, affordable health
                                      care is one of the Biden administration’s top priorities. If confirmed, I will examine
                                      rules and other policies to ensure that plans provide Americans access to the care
                                      that they need.
                                         Question. It is important to give people affordable options for health insurance.
                                      Small business owners, like Iowa farmers, want to be able to provide insurance for
                                      their employees. Association Health Plans are a way for these small businesses to
                                      band together to expand access to health insurance and drive down costs. I have
                                      introduced legislation and support efforts to expand the pathway to affordable and
                                      accessible health care remaining open to employees across America. Association
                                      Health Plans allow small businesses to join together to obtain affordable health in-
                                      surance as though they were a single large employer. The coverage offered to asso-
                                      ciation members is subject to the consumer protection requirements that apply to
                                      the nearly 160 million Americans who receive coverage from large employers. If con-
                                      firmed, will you work to maintain, modify, or rescind current regulations enabling
                                      employers and employees access to Association Health Plans?
                                         Answer. Making sure that all Americans have access to quality, affordable health
                                      care is one of the Biden administration’s top priorities. If confirmed, I will examine
                                      all rules and policies to ensure all Americans can access the care that they need.
                                         Question. I support access to affordable health-care coverage for all Iowans, re-
                                      gardless of their health status or pre-existing conditions. Americans want to be in
                                      control of their own health care. National, single-payer health systems do not allow
                                      that. The Affordable Care Act took options away from people and adopting a single-
                                      payer system will make that worse. A national, single-payer health system would
                                      eliminate private health insurance for nearly 200 million Americans and require
                                      middle-class Americans to pay much more in taxes. Single-payer health care would
                                      also dramatically increase government spending substantially, fail to meet patient
                                      needs quickly, reduce provider payments rates and reduce quality of care, and the
                                      government would have more control over health care. It also threatens the benefits
                                      that current seniors on Medicare have paid into the system their entire working
                                      lives. If confirmed, do you intend to take administrative actions to implement the




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                                      vision of a one- size-fits-all government-run health-care scheme like single-payer? If
                                      so, please describe what authority you believe you have to take such actions?
                                         Answer. President Biden has made it very clear that his goals for improving the
                                      American health-care system begin with building on the successes of the Affordable
                                      Care Act, and I am committed to working toward that goal.
                                         Question. If confirmed, will you take actions that stifles innovation and competi-
                                      tion in health care?
                                         Answer. I believe it is important to foster innovation and competition in our
                                      health-care system. CMS has a critical role in promoting these goals and ensuring
                                      access to care. Americans should have access to health-care services and products
                                      at an affordable price.
                                         Question. In 2019, the Trump administration issued two rules requiring price
                                      transparency for hospitals and health plans. The rules took effect in January 2021.
                                      This effort shines a light on the health-care industry that is all too often shrouded
                                      in secrecy. While Congress can build upon the rules, consumers can finally see sun-
                                      shine in health-care pricing. I have cosponsored legislation to codify the two health-
                                      care price transparency rules. This transparency will bring more accountability and
                                      competition to the health-care industry. Consumers should have the ability to com-
                                      pare health-care prices online so they can make an informed choice about what’s
                                      best for them and their families. If confirmed will you modify, rescind, or maintain
                                      the Trump administration’s health-care price transparency regulations?
                                         Answer. I agree that the variation in pricing across hospitals is not always justi-
                                      fied and ultimately can be bad for consumers. For transparency measures to work
                                      properly, patients and their families must be able to understand them in a meaning-
                                      ful way. If I am fortunate enough to be confirmed, I look forward to continuing to
                                      work on this issue.
                                         Question. Some States have lacked transparency in reporting their nursing home
                                      COVID–19 deaths data. For example, the State of New York undercounted nursing
                                      home deaths by as much as 50 percent and State officials intentionally withheld
                                      data for months. The New York Attorney General Letitia James released a report
                                      in January 2021 suggesting that many nursing home residents died from COVID–
                                      19 in hospitals after being transferred from their nursing homes. These figures were
                                      not reflected in the New York Department of Health’s nursing home death figures
                                      for many months suggesting the State was undercounting by as much as 50 percent.
                                      There are also reports finding New York State officials including members of New
                                      York Governor Andrew Cuomo’s staff intentionally withheld data on COVID–19-
                                      related deaths in the State’s nursing homes. Following the release of the New York
                                      Attorney General report, the New York Department of Health reported 12,743 nurs-
                                      ing home residents occurred. This included an additional 3,829 confirmed COVID–
                                      19 fatalities of those residents who had been transported to hospitals. I have warned
                                      President Biden that an across-the-board termination of 56 U.S. attorneys could im-
                                      peril ongoing sensitive investigations. This concern has been expressed by Senate
                                      Democrats. Currently, Toni Bacon is serving as the U.S. attorney for the Northern
                                      District of New York. Ms. Bacon previously served as Justice Department’s national
                                      elder justice coordinator and who currently has jurisdiction over Federal public cor-
                                      ruption crimes in the State. Bacon is the obvious choice to continue a fair and unbi-
                                      ased investigation into possible violations of civil liberties of the elderly and the
                                      public corruption. Do you believe Department of Justice must have a fair, unbiased,
                                      and experienced U.S. Attorney in the Northern District of New York, such as Ms.
                                      Bacon?
                                         Answer. I defer to the Department of Justice on the selection of U.S. Attorneys.
                                         Question. I led an effort in the Senate making additional resources available to
                                      support elder justice initiatives that assist older Americans especially throughout
                                      the COVID–19 pandemic. During the 116th Congress as Senate Finance Committee
                                      chairman I convened two hearings on elder justice initiatives and gaps in nursing
                                      home oversight. In December 2020, I urged Senate leadership to make resources
                                      available for regional or statewide strike teams to support nursing homes in crisis
                                      during this pandemic. Through this work, the end-of-year COVID–19 relief package
                                      included $100 million to support elder justice initiatives, including $50 million for
                                      State adult protective service agencies as they cope with unique challenges of serv-
                                      ing vulnerable populations during the pandemic. This work includes nursing home
                                      strike teams who have provided needed support when an outbreak occurs at a nurs-
                                      ing home or when additional resources are needed to meet the infection control or
                                      diagnostic testing requirements. Have State or Federal nursing home strike teams




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                                      been effective at controlling outbreaks and protecting vulnerable Americans? If so,
                                      can you describe how their work slowed the spread and protected lives?
                                         Answer. It has been heartbreaking to see how hard the COVID–19 pandemic has
                                      hit the Nation’s nursing homes. Nursing homes and long term care facilities are the
                                      homes for some of our most vulnerable, and we must do everything we can to work
                                      to protect them. If confirmed, I look forward to reviewing the work of the Federal
                                      nursing home strike teams.
                                         Question. The global pandemic has exposed grave concerns our society must con-
                                      front to protect the Nation’s most vulnerable citizens. Approximately 1.4 million
                                      Americans live in about 15,000 nursing homes across the country. Many Iowans
                                      have a loved one who lives in a long-term care facility. In 2019, as chairman of the
                                      Senate Finance Committee, I conducted a series of hearings to examine gaps in en-
                                      forcement of nursing home abuse. A Government Accountability Office (GAO) inves-
                                      tigation found a 103-percent increase in abuse deficiencies between 2013 and 2017.
                                      The GAO noted abuse in nursing homes is often underreported. The report docu-
                                      mented physical, mental, verbal and sexual abuse perpetrated against residents.
                                      The number of nursing home deaths attributed to COVID–19 delivers a wake-up
                                      call we can’t afford to ignore. The Federal Government needs to do a better job en-
                                      forcing compliance with standards of care. When a loved one requires a long-term
                                      care facility to deliver around-the-clock services, every family deserves peace of
                                      mind that every nursing home resident will receive high-quality, compassionate care
                                      and be treated with dignity and respect. If confirmed, how will you as administrator
                                      ensure nursing homes uphold the standard or care that is necessary while not plac-
                                      ing onerous requirements and excessive administrative burdens on nursing home
                                      staff ?
                                         Answer. Thank you for your longstanding leadership on this important issue of
                                      preventing elder abuse. This will be a focus of mine if confirmed. Nursing homes
                                      and long-term care facilities are the homes for some of our most vulnerable, and
                                      we must do everything we can to work to protect them.
                                                                                   ----

                                                             QUESTIONS SUBMITTED BY HON. JOHN CORNYN
                                                                         END STAGE RENAL DISEASE

                                         Question. Four hundred thousand Medicare beneficiaries are on dialysis, and
                                      those patients have not benefited from any meaningful innovation in their standard
                                      of care in decades. Over the last several years I have joined colleagues on both sides
                                      of the aisle and worked with CMS, the patient community and innovators to encour-
                                      age adoption of a new policy to spur innovation in medical technology for Medicare
                                      patients under the ESRD bundled payment system. CMS has made significant
                                      progress, having created the TPNIES add-on payment for innovation in medical
                                      technology used in the provision of dialysis services. However, our work is not done.
                                      CMS should better align its metrics for innovation and clinical improvements over
                                      existing technologies with the lens FDA uses to evaluate such improvements and
                                      innovations. And CMS should also extend by another year the period of time during
                                      which the add-on payment can be made, having established an application and qual-
                                      ification process via rulemaking that essentially negates the first year of the add
                                      on payment window. I will again work with my colleagues on legislation to make
                                      these additional improvements to the work CMS has already done, and hope that
                                      you will commit to working with me to achieve full success on this policy for Medi-
                                      care patients in whatever is the most expeditious and achievable path.
                                         Will you commit to working with Congress to implement these policies and bring
                                      long overdue innovation to this vulnerable group of patients?
                                         Answer. I agree that it is important to spur innovation in medical technology that
                                      improves health outcomes, particularly for patients with complex illnesses such as
                                      ESRD. I will always look for ways to improve access to innovative and effective
                                      treatments for ESRD patients, and I believe there is plenty of room for bipartisan
                                      work in this area. If confirmed, I will work with you and other members of Congress
                                      on ways to improve access to these innovative treatments.
                                                                      MEDICARE PROGRAM INTEGRITY

                                        Question. I’m very concerned about the billions of Medicare funds lost to errors,
                                      waste, fraud, and abuse. Previously, CMS expressed the need to ‘‘elevate program
                                      integrity, unleash the power of modern private sector innovation, prevent rather




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                                      than chase fraud, waste, and abuse through smart, proactive measures, and unbur-
                                      den our provider partners so they can do what they do best—put patients first.’’
                                      Also, Congress included language in the Fiscal Year 2021 appropriations encour-
                                      aging CMS ‘‘to consider pilot programs using AI-enabled documentation and coding
                                      technology to address CMS’s top program integrity priorities and reduce administra-
                                      tive burden.’’ I think we can do more to harness the expertise used in the private
                                      sector to benefit our Medicare beneficiaries and safeguard the Medicare Trust Fund.
                                      I hope this is an area of policy that we can work on together.
                                         Will you commit to working with this committee to prioritize the use of artificial
                                      intelligence and other emerging technologies to bolster Medicare program integrity
                                      and protect the Medicare Trust Fund?
                                         Answer. Fighting fraud and abuse is important for maintaining a strong Medicare
                                      program. It is my understanding that CMS has taken steps to explore the possibili-
                                      ties of artificial intelligence for program integrity purposes in addition to a host of
                                      other tools it uses to detect waste, fraud and abuse. If confirmed, I will work with
                                      you to make sure that we are good stewards of the Medicare program and taxpayer
                                      dollars.
                                                                               BUNDLED PAYMENTS

                                         Question. CMMI has recently expressed their commitment to value-based pay-
                                      ment programs but is no longer allowing new participants in the BPCI model and
                                      last week announced they won’t take new applicants to the new direct contracting
                                      model. This is creating uncertainty about the agency’s commitment. My constituents
                                      have made substantial investments in participating and /or preparing for these pro-
                                      grams and strongly believe in their importance in driving value for Medicare bene-
                                      ficiaries and the trust fund.
                                         Can you assure me as CMS Administrator that you are indeed committed to these
                                      innovative models and that you will be open to stakeholder input to improve upon
                                      CMMI models before canceling them?″
                                         Answer. The Innovation Center has been an important tool to test new models
                                      to move our system from one that rewards volume to one that rewards value. It will
                                      continue to be important, as we move forward, to test models that improve patient
                                      care, advance health equity, and lower patient costs. We have now had 10 years of
                                      experience to learn from at the Innovation Center. We need to look at what has
                                      worked and what hasn’t and chart a path forward from there. This absolutely in-
                                      cludes getting stakeholder and congressional input. If confirmed, I will work with
                                      you to make sure we are pursuing models that recognize the strides providers have
                                      already made and improve our health-care system.
                                                                   LABORATORY DATE OF SERVICE POLICY

                                         Question. In 2017, CMS established regulations at 42 CFR § 414.510(b)(5) to re-
                                      vise its date of service policy for clinical laboratory tests to allow a laboratory to
                                      bill Medicare directly for molecular pathology tests and certain Advanced Diagnostic
                                      Laboratory Tests (ADLTs) (as defined under section 1834A(d)(5)(A) of the Social Se-
                                      curity Act) performed on specimens collected from hospital outpatients. These regu-
                                      lations eliminated access delays for Medicare beneficiaries that resulted from the
                                      previous requirement that the hospital at which the specimen was collected bill
                                      Medicare for these relatively uncommon tests. Under the current policy, hospitals
                                      and SNFs are similarly incentivized to delay submitting samples which can have
                                      an impact on patient care and time to treatment.
                                         Can you commit to working in future rulemaking to address this payment policy
                                      for skilled nursing facilities and inpatient hospitals as the agency has already done
                                      in the outpatient setting?
                                         Answer. I share your desire to protect Medicare beneficiaries’ access to laboratory
                                      testing services. My understanding is that payment to a hospital or skilled nursing
                                      facility for laboratory tests furnished to an inpatient whose stay is covered under
                                      Part A is generally included in the prospective payment system rate for the facility.
                                      If I am fortunate enough to be confirmed, I would be happy to hear more from you
                                      on this important issue and work with you to improve beneficiary access to labora-
                                      tory testing.
                                                                               SURPRISE BILLING

                                        Question. Complex molecular diagnostic tests for advanced cancer have tremen-
                                      dous benefit for patients and oncologists hoping to identify the best treatments.




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                                      Many of these tests are viewed as out-of-network and have limited comparable tests
                                      for setting benchmarks.
                                        Can you commit to working with my office to make sure that access to these im-
                                      portant tests is not delayed due to surprise billing regulations promulgated under
                                      the No Surprises Act?
                                        Answer. Making sure that all Americans have access to quality, affordable health
                                      care is one of the Biden administration’s top priorities. I know that there will be
                                      a lot of work to do to implement the No Surprises Act. If confirmed, I look forward
                                      to working with you and other members of Congress to make sure that consumers
                                      are protected from surprise bills while ensuring they have access to the care that
                                      they need.
                                                             DISPROPORTIONATE SHARE HOSPITALS PAYMENTS

                                        Question. Disproportionate Share Hospitals (DSH) are owed more than $10 billion
                                      in reimbursements going back to 2005. CMS has challenged these payments based
                                      on a formula that defied congressional intent. The court have consistently ruled that
                                      CMS’s interpretation is wrong and therefore its rule making is invalid. The agency
                                      continues to fight and is planning to issue yet one more rule despite a loss on this
                                      issue at the Supreme Court.
                                        Will you commit to working to ensure DSH hospitals receive the DSH payments
                                      they are owed.
                                         Answer. Disproportionate Share Hospitals are critical to our Nation’s health-care
                                      system, providing care to low-income patients and the uninsured, and I know that
                                      this pandemic has placed significant pressure on these health-care providers. If con-
                                      firmed, I look forward to working with you and other members of Congress to en-
                                      sure CMS is using taxpayer dollars appropriately while supporting these providers
                                      and the work they do on behalf of their patients. I will also ensure that States and
                                      providers have the guidance they need to administer and participate in the Med-
                                      icaid program.
                                                                      DIALYSIS-RELATED AMYLOIDOSIS

                                        Question. We have watched for years as the Medicare program has delayed cov-
                                      erage for important medical breakthroughs offered by both prescription drugs and
                                      medical devices. Although we are aware of certain improvements over the past 2
                                      years in the coding process for new drugs and devices, the coverage process lags far
                                      behind. The result is that patients are not receiving the care they need.
                                         One recent example involves Dialysis-Related Amyloidosis (DRA), a disease that
                                      affects an estimated 3,000–5,000 patients who have been receiving dialysis treat-
                                      ment for 5 or more years. DRA results from the failure of the kidneys to filter and
                                      remove a protein called ‘‘beta-2 microglobulin,’’ cause cysts across the body, from
                                      joints to internal organs. These cysts can be extremely painful, and sometimes fatal,
                                      for those with DRA. Although for years there was no treatment available in the
                                      United States, a treatment was approved in 2015. Unfortunately, the Medicare pro-
                                      gram does not cover the treatment, which is of great concern to me and my constitu-
                                      ents.
                                         In March of 2015 the FDA approved a new treatment for DRA using a special
                                      apheresis ‘‘column’’ in which blood is taken from the patient, processed to remove
                                      an accumulation of the bad protein (beta-2 microglobulin) and returned to the pa-
                                      tient. Because the patient population is so small and the treatment was sufficiently
                                      safe, the FDA approved the treatment as a Humanitarian Use Device. Yet, despite
                                      being approved 6 years ago, I am told the Medicare program is still evaluating the
                                      appropriate coverage pathway for the treatment. Until Medicare reaches a decision,
                                      Medicare beneficiaries continue to be denied access to the only FDA approved treat-
                                      ment for DRA.
                                         Can you commit to work expeditiously to apply an appropriate Medicare benefit
                                      category and finally decide coverage for this DRA treatment, and any other Human-
                                      itarian Use Devices approved by FDA but not yet covered by the Medicare program?
                                         Answer. I agree that is it important for Medicare beneficiaries, particularly pa-
                                      tients with complex medical conditions such as ESRD, to have access to medically
                                      necessary treatments. If confirmed, I am happy to look into this further and work
                                      with you on this issue.




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                                                                                    HOSPICE

                                        Question. The COVID–19 pandemic has brought telehealth to the forefront of care,
                                      dramatically increasing accessibility and making strides toward health equity. The
                                      hospice community has rapidly expanded its telehealth services for the entire Inter-
                                      disciplinary Team, from nursing to chaplains. However, CMS does not appropriately
                                      capture telehealth claims and therefore lacks visibility into a critical aspect of hos-
                                      pice care delivery. The 2021 shift by CMS to only claims based hospice quality
                                      measurement, exacerbates this gap in essential care delivered. Creating telehealth
                                      codes for the entire hospice Interdisciplinary Team including the required chaplains’
                                      visits, would give CMS proper visibility into the hospice landscape.
                                        Will CMS commit to implementing appropriate codes for hospice’s telehealth serv-
                                      ices for every IDT discipline, including chaplain visits?
                                        Answer. Improving the safety and quality of end-of-life care is important, and
                                      telehealth has been and continues to be an important tool during the pandemic.
                                      While often at end of life, hands-on care is needed to manage symptoms, sometimes
                                      telehealth may be an appropriate and safe way to receive hospice care. If I am fortu-
                                      nate enough to be confirmed, I look forward to learning more from you about this
                                      issue and working to ensure that hospice patients have access to the highest quality
                                      care.
                                                           MA PLAN TREATMENT OF NEW TECHNOLOGY IN ESRD

                                         Question. As you know, Medicare Advantage plans are required to ensure cov-
                                      erage equal to that offered under fee-for-service. However, patient groups and other
                                      stakeholders have noted that Medicare Advantage plans may not have, or may not
                                      plan to, appropriately reimburse for End Stage Renal Disease (ESRD) drugs that
                                      are under the transitional drug add-on payment adjustment (TDAPA) through their
                                      negotiated monthly rates. Under certain circumstances this may just be a failing of
                                      timing, but what happens when new technologies appear after plans have already
                                      negotiated their rates? Failing to appropriately account for TDAPA payments puts
                                      a strain on dialysis organizations and hurts patient access to top of the line thera-
                                      pies. Additionally, many stakeholders continue to be concerned about the TDAPA
                                      ‘‘cliff.’’ After 2 years of additional payment for these innovative therapies, drugs
                                      which fall into minimally funded categories represent undue financial pressure for
                                      providers when the transitional payment goes away. This cliff can result in pro-
                                      viders having to make difficult choices about how to continue to provide innovative
                                      products to their patients.
                                         While CMS does not interfere in direct negotiations between Medicare Advantage
                                      plans and their contracted providers, it does bear responsibility for upholding parity
                                      of coverage. How will CMS rectify this patient access issue?
                                         Can you commit to patients that this and other over-arching issues with TDAPA
                                      will be something that you have CMS look at so that we can feel comfortable know-
                                      ing that the sickest patients will have access to all of these innovative therapies in
                                      the pipeline?
                                         Answer. It is important for Medicare beneficiaries with ESRD to have access to
                                      the ESRD therapies they need. Given that people with ESRD had the new option
                                      to enroll in Medicare Advantage plans for coverage beginning this year, Medicare
                                      Advantage now has a crucial role in providing access to ESRD therapies for Medi-
                                      care beneficiaries. If confirmed, I will work to ensure that beneficiaries have access
                                      to ESRD therapies under Medicare Advantage plans. I will also work to ensure that
                                      Medicare beneficiaries continue to have access to innovative therapies and to im-
                                      prove patient outcomes.
                                                        GLOBAL AND PROFESSIONAL DIRECT CONTRACTING MODEL

                                        Question. Recently CMS announced that it would not be allowing a second round
                                      of applications for the Global and Professional Direct Contracting Model. However
                                      based on multiple polls, letters to the agency, and media reports, there is a signifi-
                                      cant coalition of providers, including Baylor Scott and White in Texas, that were in-
                                      terested in participating in the second application cohort. Many providers appar-
                                      ently delayed participating in the program because of the pandemic.
                                        What will you be doing to ensure that those providers are given an opportunity
                                      participate if they want to take on risk in the Global and Professional Direct Con-
                                      tracting Model and what are the administration’s plans for this model and other
                                      models like it?




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                                        Answer. The Innovation Center has been an important tool to test new models
                                      to move our system from one that rewards volume to one that rewards value. It will
                                      continue to be important, as we move forward, to test models that improve patient
                                      care, advance health equity, and lower patient costs. We have now had 10 years of
                                      experience to learn from at the Innovation Center. We need to look at what has
                                      worked and what hasn’t and chart a path forward from there. This absolutely in-
                                      cludes getting stakeholder and congressional input. If confirmed, I will work with
                                      you to make sure we are pursuing models that recognize the strides providers have
                                      already made and improve our health-care system.
                                                                                 ALLINA RULING

                                        Question. As CMS Administrator, would you respect the ruling of the Supreme
                                      Court in the Allina case with regard to calculating DSH payments by including
                                      Medicare Advantage enrollees inpatient days who are also eligible for Medicaid?
                                        Answer. If confirmed, I will absolutely respect the Supreme Court rulings and fol-
                                      low the law.

                                                                               CHILDREN’S HEALTH

                                         Question. As CMS Administrator, you will oversee a number of programs and
                                      agencies important to children from health coverage programs vital to children’s
                                      health such as Medicaid and the Children’s Health Insurance Program (CHIP) to
                                      programs responsible for training the pediatric health-care workforce like the Chil-
                                      dren’s Hospital Graduate Medical Education Program (CHGME) to pediatric re-
                                      search initiatives at the National Institutes of Health.
                                         What are your priorities for child health, if confirmed?
                                         Answer. Programs such as Medicaid and the Children’s Health Insurance Pro-
                                      gram (CHIP) are critical programs that help ensure that children have adequate ac-
                                      cess to quality health care. If confirmed, I would work to ensure children are receiv-
                                      ing necessary health care through both programs. I would also look to better ensure
                                      access to oral health and vision care for children, as both are necessary for children
                                      to thrive in school. And we cannot forget that improving child health begins with
                                      ensuring maternal health. I will work tirelessly to reduce maternal and infant mor-
                                      tality and morbidity, using the expertise and resources across CMS and working col-
                                      laboratively with colleagues across HHS. I look forward to working with Congress,
                                      and with State and local partners to make sure that we are doing all we can to im-
                                      prove child health in this country.
                                         Medicaid and CHIP are critical programs for children, providing coverage for over
                                      40 million children. Medicaid is also the backbone of the pediatric health-care sys-
                                      tem providing care across the continuum from screenings and preventive to highly
                                      specialized diagnoses and treatments.
                                         Question. What are your plans to strengthen this safety net for children and the
                                      providers who care for them?
                                         Answer. If confirmed, I would work to support and strengthen Medicaid and CHIP
                                      to ensure that children have adequate access to quality health care. In particular,
                                      I would look to better ensure access to oral health and vision care for children, while
                                      working to reduce maternal and infant mortality and morbidity. If confirmed, I look
                                      forward to working with you to make sure our children have access to quality care.
                                         The pandemic is having a profound impact on children’s health and the providers
                                      who care for them.
                                         Question. What are your immediate plans to address the current crisis in the in-
                                      creasing number of children facing severe mental, emotional and behavioral health
                                      challenges due to social isolation and the serious impact of the pandemic on the
                                      health of their families and caregivers?
                                         Answer. I am deeply concerned about the impact of the COVID–19 pandemic on
                                      the mental, emotional, and other behavioral health outcomes of our children, their
                                      families and caregivers. I agree this must be an urgent national priority. If con-
                                      firmed, I commit to working on this issue. In particular, we must ensure that we
                                      are fully leveraging Medicaid and CHIP to connect children to the behavioral health
                                      care they need to navigate this unprecedented time, and to work toward better inte-
                                      gration of physical and behavioral health care. If confirmed, I would seek to collabo-
                                      rate with other HHS agencies, including SAMHSA, to do a better job of tackling this
                                      important issue.




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                                        Question. The pediatric health-care safety net has been affected by the pandemic
                                      in different ways then the adult health-care system, with less direct Federal finan-
                                      cial support because they are not eligible for Medicare funding streams. What are
                                      your plans to sustain a stable pediatric health-care system now and beyond the pan-
                                      demic?
                                        Answer. Medicaid and CHIP are lifelines to children and help form the fabric of
                                      the pediatric health-care safety net. Over 77 million individuals are enrolled in
                                      those programs, and about half are children. It is critical that we work to support
                                      our pediatric health-care safety net and pediatric health-care providers during the
                                      COVID–19 pandemic and beyond. If confirmed, I would make it a priority to work
                                      within CMS and with my HHS partners and State Medicaid agencies, to provide
                                      necessary support to pediatric providers.
                                        Question. The Children’s Hospital Graduate Medical Education Program
                                      (CHGME) provides significant support for the training of pediatricians and pediatric
                                      specialists. But unfortunately, the funding for this program still lags far behind the
                                      Medicare GME program—funding only half of what Medicare GME provides per
                                      resident.
                                        What are your plans to address this gap in training support for our Nation’s pedi-
                                      atric workforce?
                                        Answer. If confirmed, I will work with the resources within CMS and partner
                                      with State Medicaid agencies to support the health-care workforce, including those
                                      who work with pediatric populations. I would look forward to working with HHS
                                      partners as well, including HRSA, on ensuring access to needed health care for our
                                      Nation’s children.
                                        Question. During the pandemic telehealth has played a major role in providing
                                      access to care for Medicaid beneficiaries, including children.
                                        How will HHS support the continued use and enhancements needed under Med-
                                      icaid to ensure telehealth continues to enable access to care for children?
                                        Answer. Telehealth is an important tool to improve health equity and improve ac-
                                      cess to health care. Health care should be accessible, no matter where you live.
                                      Under current law, States have a great deal of flexibility with respect to delivering
                                      Medicaid services via telehealth. Medicaid has made great strides in expanding
                                      services available through telehealth, including pediatric services, during the public
                                      health emergency. If confirmed, I will look at the telehealth flexibilities under Med-
                                      icaid and determine how we can build on this work to improve health equity and
                                      improve access to health care for children.
                                        Question. As you know, pediatric health care is organized differently than adult
                                      health care. Pediatric care is more regionalized and often results in children, espe-
                                      cially those with complex health needs, having to travel across State lines for care.
                                      Under Medicaid, this can be challenging for them and their providers with different
                                      policies State to State. The ACE Kids Act passed in 2019 and is effective next year,
                                      is one step in addressing these inconsistencies and getting much needed national
                                      data to inform care improvements.
                                        If confirmed, how would you approach these cross-State challenges that children
                                      with complex needs face when traveling for needed care?
                                        Answer. Medicaid and CHIP are crucial to ensuring children have adequate access
                                      to quality health care, especially those with complex needs. If confirmed, I will work
                                      to ensure children are receiving necessary health care under both Medicaid and
                                      CHIP. I look forward to working across the administration and with Congress to
                                      make informed decisions that address the specific needs of children with complex
                                      medical conditions.
                                        Question. Oftentimes, changes in the larger health-care landscape take place, for
                                      example in the Medicare program, without a full examination of how these changes
                                      could potentially impact children, even inadvertently. At times, Medicare policies de-
                                      signed with the elderly population in mind have been applied to Medicaid or adopt-
                                      ed by State Medicaid programs and private payers.
                                        As you look at health-care changes at the national level as HHS Secretary, how
                                      will you ensure that children’s unique health-care needs are taken into account?
                                        Answer. If confirmed, I will work with Congress and States to spur and encourage
                                      innovation in these important programs. Innovative delivery system and payment
                                      models are vital to ensuring that Medicaid and CHIP are equipped to address




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                                      emerging pediatric health issues and can continue to provide children with access
                                      to quality health care.
                                        Question. A major focus in health care among policy-makers has been on pursuing
                                      delivery system reforms that improve quality and reduce costs. The Federal Govern-
                                      ment has traditionally focused more on adult populations rather than the needs of
                                      children in these reforms. As a result, Medicaid for children still lags behind Medi-
                                      care in supporting improvements in care and innovative payment models.
                                         What steps will you take to promote increased emphasis on these types of innova-
                                      tions in Medicaid targeting the unique needs of children?
                                        Answer. If confirmed, I will work with Congress and States to spur and encourage
                                      innovation in these important programs. Innovative delivery system and payment
                                      models are vital to ensuring that Medicaid and CHIP are equipped to address
                                      emerging pediatric health issues and can continue to provide children with access
                                      to quality health care.

                                                                   FOLLOW-UP QUESTIONS FOR THE RECORD

                                        Question. Recently, CMS announced it was withdrawing the 10-year renewal of
                                      Texas’s 1115 Medicaid waiver. The State negotiated intensively and in good faith
                                      with CMS to achieve approval of the renewal.
                                        If confirmed, how will you advise CMS to view the previous agreement reached
                                      on the budget neutrality calculation which impacts the amount of Federal Medicaid
                                      funding the State can expect to receive?
                                        Answer. Based on my experience working with many State officials throughout
                                      my career, I appreciate what is required for States to develop and submit waiver
                                      applications to CMS for consideration and approval. Additionally, I understand the
                                      challenges many States face in formulating waiver requests given their distinct
                                      budgetary processes and legislative calendars. With this in mind, if I am fortunate
                                      enough to be confirmed, I will make sure that CMS provides clear guidance and
                                      works closely with each State, including Texas, on its ideas to innovate in the Med-
                                      icaid program.
                                        Question. The waiver recession would prevent billions of dollars from flowing to
                                      Texans in need and would threaten numerous aspects of Texas’s health-care system,
                                      given Texas’s reliance for months on the extension approval. This could begin hav-
                                      ing dramatic impacts on Texas as soon as September.
                                        If confirmed, will you work with Texas to ensure that the State can continue to
                                      provide safety-net programs notwithstanding the unique challenges that the State
                                      faces?
                                        Answer. If I am fortunate enough to be confirmed, I will be happy to work with
                                      you and State officials in Texas on this issue.
                                        Question. The decision to rescind the extension comes at a time when the Biden-
                                      Harris administration continues to urge that COVID–19 is a public health emer-
                                      gency.
                                        How do you reconcile an action undermining the health care of many needy Tex-
                                      ans with the urgency of COVID–19, and if confirmed, what steps would you take
                                      to provide Texans facing potential funding losses with the care needed in light of
                                      COVID–19?
                                        Answer. While I am not an official at CMS, it is my understanding that this ex-
                                      tension was rescinded because the agency determined that the appropriate notice
                                      and public comment requirements were not met. I appreciate Congress’s leadership
                                      in making sure that patients suffering from COVID–19 have been able to get the
                                      care they need during the public health emergency, and if I am fortunate enough
                                      to be confirmed, I would look forward to working with you on this issue.
                                         Question. The letter purporting to rescind the extension would effectively overturn
                                      a discretionary decision by the former Secretary, on which Texas relied for months
                                      in planning and implementing health-care programs. This causes serious concern for
                                      Texas and other States considering whether they can rely on these types of discre-
                                      tionary decisions.
                                        If confirmed, what steps will you take to restore trust with States that are relying
                                      on such decisions in structuring their health-care systems?




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                                        Answer. I have worked closely with States throughout my career, and I under-
                                      stand the relationship with CMS as States’ Federal partner is crucial. If confirmed,
                                      I will keep in mind what I have learned working on behalf of States to make sure
                                      waiver requests are appropriately evaluated while giving the States clear guidance.
                                        Question. It has been reported that waivers like Texas’s that support uncompen-
                                      sated care pools are viewed as a roadblock to Medicaid expansion, and that they run
                                      counter to the Biden administration push for States to expand.
                                        Do you believe Medicaid expansion is the only way for States to provide care for
                                      uninsured individuals?
                                        If not, what other options are being considered by the administration?
                                        Answer. I support State innovation and the ability of States to test different mod-
                                      els that meet the objectives of the Medicaid program. No two Medicaid programs
                                      are exactly alike, just like no two States are alike. If I am so fortunate as to be
                                      confirmed, I look forward to engaging with any State that seeks to meet their popu-
                                      lation’s unique needs, including those of the most vulnerable.
                                        Question. It has also been reported that the decision to rescind the waiver was
                                      done to push State officials to accept Medicaid expansion.1
                                        Do you believe the 1115 waiver extension was rescinded in order to force Texas
                                      to expand their Medicaid program?
                                        Answer. It is my understanding that this extension was rescinded because CMS
                                      determined that the appropriate notice and public comment requirements were not
                                      met. If I am fortunate enough to be confirmed, I look forward to working with you
                                      and State officials in Texas if the State decides to resubmit a section 1115 dem-
                                      onstration extension application.


                                                             QUESTIONS SUBMITTED BY HON. RICHARD BURR
                                                                          CMS–FDA COORDINATION

                                        Question. I often hear from constituents about the reluctance of the Medicare pro-
                                      gram to cover new and innovative therapies. Even as the commercial market recog-
                                      nizes the benefits of breakthrough technologies and medicines, the Medicare pro-
                                      gram lags behind in covering novel products that can save and improve lives.
                                        A recent CBO report on pharmaceutical R&D provided a stark reminder of just
                                      how difficult it is to develop these new medicines. The costs of bringing a new drug
                                      to market have been estimated to top $2 billion.2 Given this immense cost, the Fed-
                                      eral Government should ensure a clear pathway to coverage for companies that
                                      work to meet the FDA’s gold standard of safety and efficacy and bring new treat-
                                      ments to patients.
                                        If confirmed, you will lead the agency at a time when innovative therapies and
                                      technologies are changing the way care is delivered. To meet this moment, Medicare
                                      must also adapt. I have long been a proponent of increasing the coordination be-
                                      tween CMS and FDA to ensure that our Federal health programs—and the Ameri-
                                      cans that rely on them—are prepared for the upcoming pipeline of novel tech-
                                      nologies.
                                        Will you commit to working with my office to further the goal of enhanced coordi-
                                      nation between CMS and FDA to bring innovative medical products to Americans
                                      in as timely a manner as possible?
                                        If so, what are some of the ways in which CMS could work with FDA in order
                                      to reduce the time patients wait for new treatments and therapies?
                                        Currently, there is a therapy under review at FDA that, if approved, would be
                                      indicated for the treatment of Alzheimer’s disease—a uniquely devastating illness
                                      in terms of its breadth and lethality. The action date for this therapy under the Pre-
                                      scription Drug User Fee Act is June 7, 2021. To date, FDA has only approved one

                                         1 ‘‘The decision was characterized as an effort to push State officials toward accepting the Af-
                                      fordable Care Act’s Medicaid expansion, which would cover more low-income residents, said two
                                      Federal health officials, who spoke on the condition of anonymity to discuss private conversa-
                                      tions.’’       https://www.washingtonpost.com/health/2021/04/16/biden-rejects-texas-medicaid-
                                      plan/.
                                         2 https://www.cbo.gov/system/files/2021-04/57025-Rx-RnD.pdf.




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                                      method of diagnosis for Alzheimer’s disease—a PET scan. CMS has denied Medicare
                                      coverage of PET scans for Alzheimer’s pathologies, however. If this therapy is ap-
                                      proved, Medicare’s decision to forego coverage of this diagnostic could present a bar-
                                      rier to access for patients with no other effective therapeutic options. This specific
                                      situation is just one that demonstrates the broader need for FDA and CMS coordi-
                                      nation. Will you commit to working with me on ensuring appropriate Medicare cov-
                                      erage of PET scans and other diagnostics that may benefit patients with Alzheimer’s
                                      disease?
                                        Answer. Thank you for your leadership on the issue of expanding access to the
                                      benefits of innovative medical technologies to American patients and families. It is
                                      incredible what science has been able to do with innovative drugs and treatments
                                      in recent years. We need to make sure we’re looking at modernizing the Medicare
                                      program to make sure beneficiaries have access to proven new treatments. I also
                                      think it is important for CMS to be collaborating with other agencies, including the
                                      FDA, to make sure we work better together. If I have the honor of being confirmed,
                                      I would be happy to work with you on this important issue.
                                        Question. In 2019, now-Acting FDA Commissioner Janet Woodcock testified before
                                      the House Energy and Commerce Committee that advanced manufacturing tech-
                                      nologies could enable domestic drug producers to compete with China’s lower labor,
                                      supply, and operating costs.3
                                        How can the programs administered by CMS play a role in strengthening the se-
                                      curity of supply chains, both broadly and for specific fields, like synthetic biology?
                                         Do you agree that if CMS is to play a role in addressing supply chain issues that
                                      it needs to coordinate with FDA to better understand the nuance and complexities
                                      of global supply chains?
                                         Answer. America continues to be a leader in medical innovation. This has been
                                      crucial during the pandemic. I agree that the Nation’s supply chain must be secure.
                                      If confirmed, I will make sure CMS is a helpful partner to FDA in this effort.
                                                                                 HI TRUST FUND

                                        Question. Medicare Part A has a longstanding insolvency problem. The Hospital
                                      Insurance (HI) Trust Fund that finances Part A is funded by payroll taxes and as
                                      program spending has outpaced payroll tax revenues, the balance of the trust fund
                                      has steadily declined. In February, the Congressional Budget Office (CBO) projected
                                      that the HI Trust Fund will run out of money by 2026. CBO also estimates that
                                      expenditures will continue to outpace payroll tax revenue after the trust fund has
                                      been depleted.
                                        Addressing Medicare’s finances sooner rather than later would allow for subtle,
                                      gradual changes that protect seniors’ access to high-quality care while ensuring sus-
                                      tainability for future generations. The alternative would threaten sudden and steep
                                      benefit cuts for tens of millions of senior citizens.
                                        As Administrator of CMS, if confirmed, you will be looked to by the President and
                                      Congress for leadership and assistance on reform proposals small and large. What
                                      specific experience do you have in crafting or evaluating proposals to reform the
                                      Medicare program?
                                        Answer. Medicare solvency is an incredibly important, longstanding issue. We will
                                      need both short-term and long-term strategies to make sure Medicare remains a
                                      bedrock of our health-care system, and I look forward to working with Congress on
                                      a bipartisan basis to address this. I look forward to working with you on ways to
                                      improve the solvency of the Medicare program.
                                                                               PRICE TRANSPARENCY

                                         Question. Empowering consumers with health-care price information so they can
                                      make informed health-care decisions has long been a bipartisan priority. If con-
                                      firmed as Administrator, are you committed to ensuring full implementation of the
                                      Transparency in Coverage final rule?
                                         Answer. I agree that empowering consumers with health-care price information
                                      is important. For transparency measures to work properly, patients and their fami-

                                        3 https://www.fda.gov/news-events/congressional-testimony/safeguarding-pharmaceutical-
                                      supply-chains-global-economy-10302019.




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                                      lies must be able to understand them in a meaningful way. If I am fortunate enough
                                      to be confirmed, I look forward to continuing to work on this issue.
                                                                                  FOSTER CARE

                                        Question. The Family First Prevention Services Act created a new Federal cat-
                                      egory for settings that deliver trauma-informed treatment for foster children with
                                      serious emotional or behavioral issues in a residential setting, known as Qualified
                                      Residential Treatment Programs (QRTPs). QRTPs are one of the few residential set-
                                      tings that are eligible for title IV–E reimbursement. Recently, however, the Centers
                                      for Medicare and Medicaid Services (CMS) indicated QRTPs with more than 16 beds
                                      may meet the definition of an Institutions for Mental Diseases (IMDs), preventing
                                      Medicaid reimbursement for care in these circumstances. This interpretation is not
                                      consistent with congressional intent.
                                        Do you believe that QRTPs should be exempted from the IMD payment exclusion,
                                      allowing children in foster care to have Medicaid coverage in these placements?
                                        Answer. This is an important and complex question that I am committed to ad-
                                      dressing if I am confirmed as CMS Administrator. I share your conviction that chil-
                                      dren in foster care should receive necessary medical care without disruption. If I am
                                      fortunate enough to be confirmed, I will be happy to work with you on this critical
                                      issue.
                                                                                MACPAC PROPOSAL

                                         Question. As you know, the statutory Medicaid Drug Rebate Program (MDRP) re-
                                      quires drug manufacturers to provide rebates on drugs to State Medicaid programs
                                      rebates to ensure Medicaid receives the lowest price relative to private payers.
                                      There is an additional mandatory rebate on drugs calculated according to increases
                                      in price that exceed inflation. Earlier this month, the Congressional Budget Office
                                      cited research showing that the MDRP contributes to higher prices paid by private
                                      payers, as offering additional discounts in the private markets would result in lower
                                      Medicaid revenues.4
                                        The Medicaid and Chip Payment and Access Commission (MACPAC) recently
                                      voted on recommendations to increase the amount of rebates manufacturers must
                                      pay for drugs brought to market under the accelerated approval pathway at FDA.
                                           Do you think this recommendation is appropriate?
                                        If so, what are your reasons for supporting this unprecedented approach to tying
                                      rebates to FDA approval pathways?
                                        MACPAC has acknowledged that this policy could create access issues for the
                                      Medicaid population. How would you ensure equitable access to these treatments
                                      and therapies if this policy were to be adopted?
                                         Answer. We can all agree that prescription drug costs are too high for American
                                      patients and families. From my many meetings with Senators in the last few weeks,
                                      I have seen that addressing this is a priority on both sides of the aisle. I think there
                                      is an opportunity for real impact here to lower costs for American patients and fami-
                                      lies, while making sure to continue to support innovation.
                                        Prescription drug costs, including in the Medicaid program, are very complex. Ul-
                                      timately, we need solutions that produce real results to bring down overall costs for
                                      American patients and families while avoiding barriers to access. I would be happy
                                      to examine this particular MACPAC proposal in more detail. If confirmed, I look for-
                                      ward to working with you and your colleagues to find solutions to the high cost of
                                      prescription drugs without reducing access to necessary treatments.
                                                                                CLINICAL TRIALS

                                         Question. Late last year, the Clinical Treatment Act, was signed into law. Senator
                                      Cardin and I crafted this legislation to ensure Medicaid beneficiaries have access
                                      to clinical trials by requiring State Medicaid programs to provide coverage of routine
                                      medical care associated with the trial—a benefit already provided by Medicare. This
                                      law will improve access to potentially life-saving therapies for sick Americans as
                                      well as broaden the base of clinical trial participants, which will improve the ability
                                      of manufacturers to conduct these trials.

                                           4 https://www.cbo.gov/system/files/2021-04/57020-Public-Option.pdf.




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                                         How will you ensure that this important benefit is available to Medicaid bene-
                                      ficiaries as expeditiously as possible?
                                         Answer. If I am fortunate enough to be confirmed, I will work with the National
                                      Institutes of Health and with trusted partners in the community to help to encour-
                                      age participation in clinical trials, which—as you noted—can offer potentially life-
                                      saving treatment opportunities to patients. One barrier to participation in these
                                      trials can be payment for routine medical care associated with the trial, so I think
                                      it is so important that Medicaid will pay for covered items and services provided
                                      as part of qualifying clinical trials starting January 1, 2022. If confirmed, I would
                                      look forward to working with you, Senator Cardin and other members of Congress
                                      on this issue as we work to implement this important benefit in a timely manner.
                                                                                     CMMI

                                         Question. The Patient Protection and Affordable Care Act (PPACA) created the
                                      Centers for Medicare and Medicaid Innovation (CMMI) and afforded it broad au-
                                      thority to test new payment models. The law requires the termination or modifica-
                                      tion of any model that does not improve quality of care without increasing spending;
                                      reduce spending without reducing quality of care; or improve quality of care while
                                      also reducing spending. Shockingly, the PPACA also included a clause attempting
                                      to block any administrative or judicial review of CMMI demonstration models, leav-
                                      ing the Administrator as a key, potentially unaccountable, arbiter of whether or not
                                      the law’s requirements are being followed.
                                         How specifically will you ensure that statutory requirements for CMMI models
                                      are stringently adhered to? Will you commit to working with members of this com-
                                      mittee to establishing a permanent mechanism for congressional input and over-
                                      sight?
                                         Answer. The Innovation Center has been an important tool to test new models
                                      to move our health-care system from one that rewards volume to one that rewards
                                      value. It will continue to be important, as we move forward, to test models that im-
                                      prove patient care, advance health equity, and lower patient costs. We have now
                                      had 10 years of experience to learn from at the Innovation Center. We need to look
                                      at what has worked and what hasn’t and chart a path forward from there. If I am
                                      fortunate enough to be confirmed, I want to have open lines of communication with
                                      Congress, and I look forward to hearing from you about CMMI models.
                                                                   CLINICAL LABORATORY FEE SCHEDULE

                                         Question. The Medicare Clinical Lab Fee Schedule (CLFS) payment rates for anti-
                                      gen testing that use visual interpretation for results have traditionally been the
                                      same as the tests that utilize instruments to interpret results. However, CMS has
                                      recently changed this practice for COVID–19 testing, bifurcating the rates for these
                                      types of tests. This bifurcation occurred in June 2020.
                                         Why does CMS believe that a bifurcation in reimbursement rates was warranted
                                      in the case of SARS–CoV–2 antigen testing?
                                         Under your leadership, how would CMS incentivize the development of digital
                                      health technologies that make diagnostic test results accurate and reliable?
                                         Answer. Access to safe and reliable testing is key to combating the COVID–19
                                      pandemic. If I am fortunate enough to be confirmed, I look forward to hearing from
                                      you about Medicare’s clinical laboratory fee schedule rates and protecting bene-
                                      ficiary access to laboratory testing services, including digital technologies where ap-
                                      propriate.
                                                                                   ----

                                                          QUESTIONS SUBMITTED BY HON. PATRICK J. TOOMEY
                                        Question. As part of the American Rescue Plan Act (ARPA; Pub. L. 117–2), ap-
                                      proximately $35 billion is estimated to be spent to temporarily expand Obamacare
                                      subsidies to current marketplace enrollees and individuals making over 400 percent
                                      of the Federal poverty level, including high-income earners or those making over
                                      six-figure salaries. The majority of these subsidies will go to individuals who already
                                      have health insurance. Furthermore, taxpayers are expected to spend an additional
                                      $6 billion to temporarily pause premium tax credit reconciliation for plan year
                                      2020—meaning individuals who received more than they should will not be asked
                                      by the Federal Government to repay taxpayers for those improper subsidies. In the
                                      past, multiple government watchdogs have concluded that these taxpayer subsidies




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                                      are susceptible to significant improper payments. As the Federal deficit hits records
                                      highs, more must be done to ensure our taxpayer dollars are spent wisely.
                                        You have extensive programmatic experience with the Federal marketplace and
                                      Virginia’s State marketplace. If confirmed, how will you work with the Internal Rev-
                                      enue Service to reduce the advance premium tax credit program’s susceptibility to
                                      improper payments? Please be specific.
                                        Answer. Advance payments of premium tax credits have helped make health in-
                                      surance more affordable for millions of Americans and improved their access to care.
                                      This has been especially important during the pandemic when access to affordable
                                      health care has been more critical than ever. If confirmed, I will take seriously these
                                      responsibilities, including working with the Internal Revenue Service to make sure
                                      that we are good stewards of Federal dollars.
                                        Question. Over the years, the Medicare improper payment rate has dropped well
                                      below 10 percent. In fact, the improper payment rate for FY2020 dropped to 6.27
                                      percent from 7.25 percent in FY 2019—its lowest rate in more than a decade. Fur-
                                      ther, over the past decade, the Medicare Advantage and Part D improper payment
                                      rates at their highest reached 11 percent and 3.7 percent respectively. In FY2020,
                                      the Medicare Advantage and Part D improper payment rates dropped to 6.78 per-
                                      cent and 1.15 percent respectively. Unlike the Medicare program, however, the Med-
                                      icaid improper payment rate has ballooned. Most recently, the national improper
                                      payment rate in Medicaid was 21.36 percent, or $86.49 billion. Not only has the
                                      Medicaid improper payment rate doubled since 2010, but it is now more than triple
                                      the improper payment rate of the Medicare program.
                                        If confirmed, what actions will you take to bring the improper payment rate in
                                      the Medicaid program under 10 percent? Please be specific.
                                        Answer. Medicaid is a critical lifeline for beneficiaries across the country. Reduc-
                                      ing Medicaid improper payments is a priority because it helps ensure the fiscal
                                      health of the program. If confirmed, I will work with States and leaders in Congress
                                      to be responsible stewards of taxpayer dollars.
                                        Question. Last fall, Senator Stabenow and I sent the Department of Health and
                                      Human Services a detailed letter recommending specific regulatory actions to im-
                                      prove our Federal health-care programs for beneficiaries with Alzheimer’s disease.
                                      These recommendations were formed with input from more than 30 organizations
                                      that responded to a request for information as well as hearings and briefings led
                                      by Senator Stabenow and myself. Recently, the Biden administration took action on
                                      one of our recommendations and finalized a centralized website for patients and
                                      their caregivers to access information regarding their care options and clinical trial
                                      enrollment. However, other recommendations remain unimplemented.
                                        If confirmed, how will you help increase access to innovative diagnostic tools and /
                                      or make improvements to existing methods of assessing cognitive impairment, such
                                      as direct observation, in the Medicare program to improve early detection of Alz-
                                      heimer’s disease? Additionally, with the potential for the first disease modifying
                                      drug to be approved by the U.S. Food and Drug Administration, existing tools like
                                      the amyloid PET scan are the only option for confirmatory diagnosis until a non-
                                      invasive, affordable, and rapid diagnostic tool, such as a blood test, is made avail-
                                      able to the public. Coverage determinations play a large role in diagnosing, treating,
                                      connecting to wrap-around services, and clinical trial enrollment. If confirmed, will
                                      you examine existing CMS coverage policies to ensure the Medicare program pro-
                                      vides seamless access to the best diagnostic tool(s) available to this patient popu-
                                      lation and other similarly situated disease groups?
                                        How can the Medicare Advantage program play a role in strengthening care co-
                                      ordination among this population?
                                        What other policies will you prioritize to improve the lives of Medicare and Med-
                                      icaid beneficiaries living with Alzheimer’s disease?
                                        Answer. Alzheimer’s disease is a devastating condition for patients and families.
                                      Early detection is critical to improve care, and I agree that CMS should work to
                                      improve coverage of proven diagnostics. I also agree that better coordinating health-
                                      care benefits patients, and we should strive to improve care coordination across pro-
                                      grams. Medicaid and Medicare, including Medicare Advantage, have an important
                                      role to play in providing this type of quality care, including to those living with com-
                                      plex conditions like Alzheimer’s disease. I would be happy to work with you on this
                                      important issue should I be confirmed.




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                                         Question. Through section 1115 waiver authority, State Medicaid programs can
                                      waive certain programmatic requirements to implement greater flexibilities with
                                      their eligibility, benefit, and delivery systems. CMS plays an instrumental role in
                                      the implementation of section 1115 waivers through the negotiation process and
                                      oversight of their financial performance.
                                         If confirmed, how would you work to uphold and enforce the longstanding policy
                                      of budget-neutrality for section 1115 waivers and ensure the integrity of their finan-
                                      cial performance?
                                         Answer. Each State is unique, and innovation is critical to improving the health-
                                      care system. Section 1115 demonstration projects, or waivers, are one available tool
                                      to States to help test new and innovative policies in Medicaid. I agree that it is im-
                                      portant that we are good stewards of taxpayer dollars while pursuing innovation.
                                      If confirmed, I will support State innovation and the ability of States to test out
                                      different models that meet the objectives of the Medicaid program.

                                                                                   ----
                                                               QUESTIONS SUBMITTED BY HON. TIM SCOTT
                                                   ON LEVERAGING VIRTUAL HEALTH TECHNOLOGY AND TELEHEALTH
                                                                   TO EXPAND ACCESS TO CARE

                                      On Enhancing Telehealth Access
                                         Question. Earlier this Congress, joined by Senator Schatz and a bipartisan group
                                      of my Senate colleagues, I introduced the Telehealth Modernization Act, legislation
                                      aimed at increasing access to high-quality health-care services, particularly for our
                                      Nation’s seniors, by codifying crucial flexibilities for telehealth coverage.
                                         Long before the pandemic began, South Carolina had emerged as a leader in tele-
                                      health innovation, hosting one of just two federally recognized Telehealth Centers
                                      of Excellence in the Nation. High-quality telehealth services and networks spear-
                                      headed by cutting-edge providers like the Medical University of South Carolina have
                                      transformed the Palmetto State’s health-care landscape. Unfortunately, however, for
                                      the majority of the State’s roughly 1 million Medicare beneficiaries, outdated cov-
                                      erage restrictions have long inhibited access to telehealth services.
                                         For years, rigid rules around patient location (geographic and site of service), eli-
                                      gible services and provider sites, and other components of care have created sub-
                                      stantial barriers to telehealth utilization. In February 2020, for instance, just prior
                                      to the COVID–19 public health emergency (PHE), only 0.1 percent of Medicare fee-
                                      for-service (FFS) primary care visits were delivered via telehealth. In any given
                                      week before the PHE, an average of just 14,000 Medicare beneficiaries received a
                                      telehealth service.
                                         Congress took decisive steps towards expanding telehealth access through the
                                      CHRONIC Care Act, particularly for the roughly 36 percent of Medicare bene-
                                      ficiaries nationwide who have chosen to enroll in Medicare Advantage (MA) plans,
                                      more than three-quarters of which provided extra telehealth benefits, even before
                                      the pandemic struck. For South Carolina, however, MA penetration remained below
                                      30 percent last year. For the 72 percent of SC’s Medicare beneficiaries enrolled in
                                      FFS coverage, substantial restrictions have remained.
                                         While these Medicare access gaps predated the pandemic, the spread of COVID–
                                      19 highlighted the urgency of updating telehealth coverage rules, prompting Con-
                                      gress to provide authority for pivotal emergency waivers designed to ensure safe ac-
                                      cess to care for seniors and other vulnerable populations. As the pandemic raged,
                                      Medicare beneficiaries turned to telehealth services to minimize viral exposure risk
                                      and receive medically necessary care in safe and accessible settings. In April 2020,
                                      more than two-fifths (43.5 percent) of Medicare FFS primary care visits were pro-
                                      vided through telehealth, and from mid-March through early July of that year, more
                                      than 10.1 million beneficiaries accessed telehealth services.
                                         Without congressional action, however, these emergency flexibilities will expire at
                                      the end of the PHE, creating an access cliff for tens of millions of Medicare bene-
                                      ficiaries, including many who have come to rely on telehealth for critically needed
                                      care.
                                         If confirmed, can you commit to making the expansion of telehealth access, par-
                                      ticularly for seniors and vulnerable populations, a priority for the Centers for Medi-
                                      care and Medicaid Services (CMS)?




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                                         The Telehealth Modernization Act would eliminate a number of outdated restric-
                                      tions on Medicare coverage for telehealth services, including by removing geographic
                                      and originating site restrictions and ensuring that federally qualified health centers
                                      and rural health clinics can continue to serve as distant sites, even after the pan-
                                      demic subsides. Would you support these types of policy proposals as a means of
                                      expanding access to care?
                                         Can you commit, if confirmed, to working with my office, Sen. Schatz’s office, and
                                      the offices of other telehealth access supporters to ensure that the tens of millions
                                      of Medicare beneficiaries enrolled in FFS do not face a coverage cliff when the pub-
                                      lic health emergency expires?
                                         In the absence of the emergency waivers, what would you cite as some of the most
                                      significant barriers to telehealth access, particularly for seniors and those with seri-
                                      ous health conditions, and what steps would you take as CMS Administrator, if con-
                                      firmed, to address some of these barriers?
                                         What role or roles do you see telehealth and other virtual health technologies in
                                      playing within the administration’s broader goal of combating health disparities?
                                         I see our digital infrastructure as a powerful tool in addressing health disparities.
                                      If confirmed, how would you work with other Federal agencies and officials to bol-
                                      ster broadband access and bridge the digital divide?
                                         Answer. Telehealth has been invaluable during this pandemic to keep patients,
                                      their providers, and their families safe. My brother is a psychologist, and telehealth
                                      has helped his patients get the care they need. Additionally, I agree that telehealth
                                      services have improved health equity as beneficiaries have used telehealth to access
                                      care during the COVID–19 pandemic. Broadband access is a challenge for many pa-
                                      tients, however, and I agree that digital infrastructure is an important issue to con-
                                      sider in the context of addressing health disparities. If confirmed, I want to be sure
                                      we learn lessons from this pandemic on telehealth about what we can and should
                                      extend administratively and what will need congressional action.
                                      On Improving the Medicare Diabetes Prevention Program (MDPP) Expanded Model
                                         Question. The Medicare Diabetes Prevention Program (MDPP) Expanded Model
                                      (EM) leverages proven interventions to prevent the onset of type 2 diabetes in Medi-
                                      care beneficiaries with prediabetes. In 2016, the Chief Actuary of CMS certified that
                                      ‘‘beneficiaries participating in diabetes prevention programs have achieved success
                                      with losing weight and reducing the incidence of diabetes’’ and that the expansion
                                      was ‘‘expected to reduce Medicare expenditures.’’ According to CMS, the program at
                                      the core of the expanded model ‘‘has been shown to reduce the incidence of diabetes
                                      by 71 percent in persons age 60 years or older.’’
                                         Unfortunately, the exclusion of innovative virtual suppliers from the MDPP EM
                                      has impeded the program’s reach and created substantial access gaps, particularly
                                      for older Americans living in rural and underserved urban communities. Politico re-
                                      ported that only 202 beneficiaries had used the program in 2018, and an American
                                      Journal of Managed Care study published in June 2020 concluded that ‘‘inadequate
                                      MDPP access’’ stemmed in part from ‘‘severe shortages’’ of suppliers, particularly in
                                      States with large populations of Medicare beneficiaries of color. The COVID–19 pan-
                                      demic has highlighted and exacerbated these access barriers, but regulatory flexi-
                                      bilities remain limited.
                                         In order to address these access gaps, last Congress, I partnered with Senator
                                      Warner in leading a number of letters to HHS and CMS leaders, urging them to
                                      take administrative action to enable the participation of CDC-recognized virtual
                                      suppliers in the MDPP EM. We also introduced the bipartisan, bicameral PREVENT
                                      DIABETES Act, which would accomplish the same goal legislatively. Unfortunately,
                                      virtual suppliers remain excluded from the program, and even the flexibilities pro-
                                      vided for the pandemic emergency period have proven unable to improve access for
                                      beneficiaries in need.
                                         The Biden administration has cited combating health disparities as a key policy
                                      priority. According to the CDC, 13 percent of American adults have diabetes, includ-
                                      ing 26.8 percent of those aged 65 or older. Diabetes prevalence varies substantially
                                      by race/ethnicity, affecting 16.4 percent of black adults, 14.9 percent of Asian adults,
                                      and 14.7 percent of Hispanic adults, versus 11.9 percent of white adults. A 2018
                                      study that focused specifically on the provision of DPP services through virtual pro-
                                      viders found statistically significant evidence of reduced costs and utilization pat-
                                      tern changes for a Medicare population, suggesting that the inclusion of virtual sup-
                                      pliers in MDPP, among other actions to strengthen the program, could help to ad-




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                                      dress disparities, reduce costs, and improve outcomes for older Americans across the
                                      board.
                                        If confirmed, can you commit to working, in consultation with my office, Senator
                                      Warner’s office, and other policy-makers, to enhance access to the Medicare Diabe-
                                      tes Prevention Program?
                                        Can you commit to reviewing the robust evidence base and giving due consider-
                                      ation to the bipartisan and bicameral requests that I have led, in partnership with
                                      Senator Warner and others, to secure the inclusion of CDC-recognized virtual sup-
                                      pliers in the MDPP EM?
                                        Beyond the MDPP EM, how do you envision CMMI’s role in terms of facilitating
                                      the demonstration and evaluation of virtual care solutions and digital health tools?
                                        More broadly, can you speak to the administration’s efforts to enable Medicare
                                      beneficiaries to leverage digital health tools for the prevention and treatment of dis-
                                      ease? Are their limitations in your ability to expand access to these valuable re-
                                      sources for those that want to use them within Medicare?
                                        Answer. The Medicare Diabetes Prevention Program is an important model, and
                                      I appreciate your leadership in supporting patients with diabetes. I absolutely want
                                      to look at all options to help prevent diabetes, and I look forward to hearing more
                                      from you, Senator Warner, and other members of Congress on ways we can improve
                                      the program for Medicare beneficiaries.
                                        The Innovation Center has been an important tool to test new models to move
                                      our system from one that rewards volume to one that rewards value. It will continue
                                      to be important, as we move forward, to test models that improve patient care, ad-
                                      vance health equity, and lower patient costs. We have now had 10 years of experi-
                                      ence to learn from at the Innovation Center. We need to look at what has worked
                                      and chart a path forward from there. I look forward to hearing more of your
                                      thoughts on the direction of CMMI.
                                                                   ON ENHANCING ACCESS TO INNOVATION

                                         Question. As co-chair of the bipartisan, bicameral Personalized Medicine Caucus,
                                      I have long championed the potential for cutting-edge innovations like gene and cell
                                      therapies to transform the treatment landscape. In recent years, the pace of devel-
                                      opment on these fronts has accelerated, with a report from last Spring suggesting
                                      that more than 360 gene and cell therapies were in the United States’ clinical pipe-
                                      line, versus fewer than 300 just 2 years earlier. More than one-third of these thera-
                                      pies aim to treat rare diseases, providing cause for optimism to patients across the
                                      country, as 95 percent of the 7,000 known rare diseases currently lack an FDA-
                                      approved treatment option. Individuals with sickle cell disease, for instance, which
                                      affects an estimated 100,000 Americans, could feasibly see a cure on the horizon.
                                        According to a 2019 statement by key FDA leaders, the agency anticipated, at
                                      that point, approving 10 to 20 new gene and cell therapies every year by 2025, in
                                      addition to receiving a projected 200 investigational new drug applications for gene
                                      and cell therapy candidates annually, beginning in 2020.
                                        I appreciate the emphasis that you placed, in your testimony, on advancing inno-
                                      vation.
                                        That said, even in the face of these potentially lifesaving developments, hurdles
                                      remain, even for gene and cell therapies that successfully gain FDA approval. A
                                      number of laws and regulations around Medicaid ‘‘best price,’’ the Anti-Kickback
                                      Statute (AKS), and the Stark Law, among other relevant statutes, understandably
                                      failed to contemplate this new generation of gene and cell therapies, which have
                                      only recently begun to come to market.
                                        A disproportionate share of the patients affected by the diseases most likely to
                                      be treated by the early waves of gene and cell therapies receive health-care coverage
                                      through Medicare or Medicaid. With that in mind, would you agree that HHS
                                      should do all that it can to ensure access to FDA-approved cell and gene therapies
                                      when a doctor and a patient agree that it is the most appropriate treatment option?
                                        The current Medicaid reimbursement structure was not designed with curative
                                      therapy payments in mind. For the roughly 100,000 Americans affected by SCD and
                                      other painful and debilitating conditions, these outdated rules risk delaying patient
                                      access and hinder Medicaid’s ability to pay for innovative therapies based on their
                                      value. How will HHS overcome barriers in the current Medicaid reimbursement




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                                      structure for cell and gene therapies, giving patients access to cures and not just
                                      treatments?
                                         In December, HHS finalized the ‘‘Establishing Minimum Standards in Medicaid
                                      State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing
                                      (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third
                                      Party Liability (TPL) Requirements (CMS 2482–F)’’ rule, which took important
                                      steps towards ensuring that State Medicaid programs have the flexibility they need
                                      to hold manufacturers accountable for the performance of their therapies. Will CMS
                                      commit to implementing the VBP components of this rule and ensuring that pa-
                                      tients have timely access to lifesaving cell and gene therapies?
                                         If and when CMS implements this rule, barriers to value-based arrangements will
                                      remain, both within the Federal health-care programs and in the private sector. Can
                                      you commit, if confirmed, to working with my office to develop the additional legisla-
                                      tive and regulatory solutions needed to facilitate meaningful value-based arrange-
                                      ments for drugs, biologics, devices, and other innovative medical products?
                                         The prior administration issued new AKS safe harbors to protect value-based ar-
                                      rangements among health-care providers and other industry stakeholders, but
                                      value-based arrangements for drugs and biologics received no such protections, in-
                                      hibiting the development of these types of agreements and jeopardizing patient ac-
                                      cess to innovation. Will you commit to developing a safe harbor that would help pro-
                                      mote greater innovation in the pricing of drugs and biologics?
                                         Generally speaking, what changes do you envision to CMS’s policies that would
                                      promote the development of curative medicines to ensure that they are available to
                                      Americans as soon as possible?
                                         With respect to sickle cell disease (SCD) in particular, can you commit to making
                                      efforts to combat SCD, both through novel gene therapies and through other innova-
                                      tive treatments and care models, a priority for CMS?
                                         While surveillance data on the SCD patient population remains limited in many
                                      ways, research suggests that the majority of individuals affected by SCD may re-
                                      ceive health-care coverage through Medicaid, giving CMS an especially significant
                                      role in ensuring access to care for these Americans. Would you be willing to consider
                                      pilot programs, demonstration projects, or other innovative models to drive care im-
                                      provement for those affected by SCD?
                                         Answer. It is incredible what scientific progress has been made with innovative
                                      drugs and treatments in recent years. We need to make sure we are looking at mod-
                                      ernizing the Medicare and Medicaid programs to foster innovation and to make sure
                                      beneficiaries have access to proven new treatments. Thank you for your leadership
                                      on Sickle Cell Disease.
                                         If confirmed, I look forward to working with you and other members to find solu-
                                      tions to improve treatments, care models, and access to new therapies, including for
                                      Sickle Cell Disease.
                                         Question. FDA has testified ‘‘that advanced manufacturing technologies could en-
                                      able U.S.-based pharmaceutical manufacturing to regain its competitiveness with
                                      China.’’
                                         How can CMS leverage and advance the U.S. advantage in synthetic biology to
                                      solidify our domestic drug supply chain security?
                                         Answer. America continues to be a leader in medical innovation. This has been
                                      crucial during the pandemic. I agree that the Nation’s supply chain must be secure.
                                      If confirmed, I will make sure CMS is a helpful partner to the FDA in this effort.
                                      On Coverage and Payment for Products Approved via Accelerated Approval
                                         Question. As described by FDA, the Accelerated Approval Program ‘‘allow[s] for
                                      earlier approval of drugs that treat serious conditions, and that fill an unmet med-
                                      ical need based on a surrogate endpoint,’’ meaning ‘‘a marker, such as a laboratory
                                      measurement, radiographic image, physical sign or other measure that is thought
                                      to predict clinical benefit, but is not itself a measure of clinical benefit.’’ Further-
                                      more, as explained by the agency, ‘‘[t]he FDA bases its decision on whether to accept
                                      the proposed surrogate or intermediate clinical endpoint on the scientific support for
                                      that endpoint’’ (emphasis mine).
                                         In explaining the rationale for the creation of Accelerated Approval, FDA has
                                      noted that the use of intermediate or surrogate endpoints ‘‘can save valuable time
                                      in the drug approval process.’’ In the example of cancer survival, for instance, the




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                                      agency points out that measuring the extension of survival for cancer patients could
                                      take many years, whereas trials can assess tumor shrinkage, which is reasonably
                                      likely to predict the desired endpoint, much more efficiently. In this broad example,
                                      the use of accelerated approval could result in patient access to a life-saving product
                                      literally years earlier than might have been possible otherwise. For countless Ameri-
                                      cans, from children suffering from debilitating cancers to adults afflicted by rare
                                      blood disorders, access to drugs and biologics cleared through the Accelerated Ap-
                                      proval pathway have been the difference between life and death.
                                         As we look towards the months and years ahead, scores of patients can look to
                                      Accelerated Approval and other innovative, evidence-based pathways as a source of
                                      hope, recognizing that a new generation of game-changing therapeutics could fea-
                                      sibly cure conditions like sickle cell disease.
                                         In 2018, CMS wrote to States affirming that drugs approved via the Accelerated
                                      Approval pathway ‘‘must be covered by State Medicaid programs, if the drug meets
                                      the definition of ‘covered outpatient drug,’ noting that said products ‘‘must meet the
                                      same statutory evidentiary standards for safety and effectiveness as those granted
                                      traditional approvals.’’ Can you commit to ensuring, if confirmed, that every State
                                      Medicaid program covers all covered outpatient drugs approved via the Accelerated
                                      Approval Program, with no difference in treatment between these products and
                                      products approved via the traditional approval pathway?
                                         Despite substantial pushback from patient advocates and policymakers, the Med-
                                      icaid and CHIP Payment and Access Commission (MACPAC) has moved to advance
                                      a proposal that would create a differential rebate structure for products approved
                                      via the Accelerated Approval Program, essentially penalizing drugs and biologics for
                                      moving to market and serving patients more quickly. In addition to disincentivizing
                                      the use of the Accelerated Approval pathway and thus denying scores of Americans,
                                      including many childhood cancer patients, with timely access to potentially life-
                                      saving medications, this policy risks deterring, chilling, or otherwise redirecting in-
                                      vestment in products that do not lend themselves to efficient trials with easily and
                                      expeditiously measured primary endpoints. Moreover, the framing of the proposal
                                      itself suggests a misunderstanding of the scientific integrity and underlying purpose
                                      of the Accelerated Approval Program. Before advocating for or otherwise seeking to
                                      advance any policy proposals that might weaken, penalize, or otherwise chill the use
                                      of the Accelerated Approval Program, can you commit to engaging with FDA offi-
                                      cials and experts, patient advocates, manufacturers, policymakers on the Hill, and
                                      other relevant stakeholders to assess the potential consequences of such policies?
                                         Regardless of the administration in question, critics have often argued that FDA
                                      and CMS could and should work more collaboratively to ensure that safe and effec-
                                      tive products can come to market as efficiently as possible. Can you commit to work-
                                      ing with your counterparts at FDA to bolster collaboration and communication be-
                                      tween the two agencies?
                                         Answer. Thank you for your leadership on the issue of expanding access to the
                                      benefits of innovative medical technologies to American patients and families. It is
                                      incredible what scientific progress has been made with innovative drugs and treat-
                                      ments in recent years. We need to make sure we’re looking at modernizing the
                                      Medicare and Medicaid programs to make sure beneficiaries have access to proven
                                      new treatments. I also think it is important for CMS to be collaborating with other
                                      agencies, including the FDA, to make sure we are working together to serve pa-
                                      tients. I would be happy to examine this particular MACPAC proposal in more de-
                                      tail. If confirmed, I look forward to working with you and your colleagues to find
                                      solutions to the high cost of prescription drugs without reducing access to necessary
                                      treatments.
                                      On Payment for FFR/iFR Technologies
                                         Question. CMS has recently committed to reexamining the Medicare payment pol-
                                      icy for specific procedures performed in an Ambulatory Surgical Center (ASC) to en-
                                      sure that physicians can ‘‘exercise their clinical judgement in making site-of service
                                      determinations.’’ One such policy that warrants reexamination is the ASC payment
                                      for fractional flow reserve and instantaneous wave-free ratio (FFR/iFR), technologies
                                      that accurately measure blood pressure and flow through a specific part of the coro-
                                      nary artery which can be critical for physicians in making treatment decisions for
                                      their patients.
                                         Many doctors rely on these technologies to assess whether to perform percu-
                                      taneous coronary intervention (PCI), driving improvements in quality of care and
                                      cost savings. However, the current Medicare ASC payment policy to package pay-




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                                      ment for FFR/iFR results in a payment rate that is three times lower than the out-
                                      patient hospital setting, where a complexity adjustment accounts for the cost of this
                                      important technology. The current ASC payment policy for FFR/iFR has made these
                                      procedures out-of-reach for physicians and Medicare beneficiaries in an ASC. Many
                                      stakeholders, including the Society for Cardiovascular Angiography and Interven-
                                      tions (SCAI) and the American College of Cardiology (ACC), have expressed con-
                                      cerns over this policy and have called for a change, whether by separately paying
                                      for FFR/iFR or providing a payment adjustment similar to the adjustment provided
                                      under the outpatient setting.
                                        If confirmed as Administrator, will you commit to reexamining this ASC policy in
                                      the upcoming rulemaking cycle and considering changes to the policy to make FFR/
                                      iFR a viable option for providers and patients in an ASC?
                                        Answer. As more and more services can be provided on an outpatient basis in var-
                                      ious settings, we need to be thoughtful about the incentives Medicare payment poli-
                                      cies have on utilization in these sites of care. If confirmed, I will make sure that
                                      CMS continues to examine how payment policies that vary by site of care impact
                                      quality of care and cost savings, especially for technologies that are critical for mak-
                                      ing treatment decisions.
                                                                                 ON VACCINES

                                      On Seniors’ Access to Preventive Care
                                         Question. While Medicare Part B covers a number of vaccines, including for influ-
                                      enza, pneumococcal, and hepatitis B, with no beneficiary cost-sharing, the majority
                                      of vaccines recommended for adults, including for older adults, are covered under
                                      Part D, where seniors can face substantial copays. While cost-sharing can serve as
                                      a useful and appropriate tool in other contexts, those rationales do not apply in the
                                      case of ACIP-recommended vaccinations, and studies have shown a direct correla-
                                      tion between cost-sharing and increased abandonment rates for vaccines.
                                        As a number of my colleagues and I noted in a letter we sent to CMS on this
                                      subject last summer, ‘‘A 2017 report by Avalere Health found between 47 and 72
                                      percent of the 24 million Medicare beneficiaries with Part D coverage had some
                                      level of cost sharing for vaccines, ranging from $35 to $70 in 2015. Another study
                                      found that only 4 percent or less of Medicare Part D enrollees had access to vaccines
                                      with no cost sharing.’’
                                        How can the Biden administration address the issue of ensuring medically nec-
                                      essary preventive care for all populations?
                                         Answer. Making sure that all Americans have access to quality, affordable health
                                      care is one of the Biden administration’s top priorities. I look forward to working
                                      with Congress to find ways to ensure preventive care, including recommended vac-
                                      cinations, is accessible for all populations served by CMS programs. If confirmed,
                                      I will work with stakeholders and trusted partners to educate providers, bene-
                                      ficiaries, and families, and encourage individuals to seek preventive care.
                                                                         ON MEDICARE ADVANTAGE

                                         Question. A growing share of Medicare beneficiaries, rising from just one-quarter
                                      in 2010 to 39 percent in 2020, have chosen to enroll in Medicare Advantage (MA)
                                      plan, which enjoy a 94-percent satisfaction rate. MA has enjoyed increasingly strong
                                      bipartisan backing, with 64 senators and 339 members of the House signing on to
                                      a letter of support for the program last year.
                                         MA plans cover an increasingly broad array of extra benefits, relative to the fee-
                                      for-service model. Of all MA plans, 88 percent cover hearing aids and 91 percent
                                      cover glasses and eye exams, while 92 percent include dental benefits and 96 per-
                                      cent have a fitness benefit.
                                         Given the overwhelming bipartisan support and the additional benefits, as well
                                      as the growing competition in the MA market, what steps would you look to take,
                                      if confirmed, to continue increasing access to and education on MA options for sen-
                                      iors?
                                         Answer. Medicare Advantage serves millions of Americans and is an important
                                      option for all beneficiaries, including older Americans and people with disabilities.
                                      I believe that we have to take every approach we can to provide people access to
                                      quality health care. If confirmed as CMS Administrator, I look forward to working
                                      with Congress on this important issue.




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                                      On Integrating Certain Diagnoses Obtained via Audio-Only Telehealth Visits for
                                           Risk Adjustment Purposes
                                        Question. South Carolina has seen substantial growth in MA market penetration
                                      in recent years. As a share of all Medicare beneficiaries across the State, MA enroll-
                                      ment has nearly doubled in the past decade, from 16 percent of total Medicare en-
                                      rollment in 2010 to 31 percent in 2020. We have also seen increased interest in Pro-
                                      grams of All-Inclusive Care for the Elderly (PACE), another innovative model in-
                                      tended to drive value-based care, particularly for those dually eligible for Medicare
                                      and Medicaid. While PACE has a much smaller population of participants, more
                                      than 400 reside in SC, receiving care across three different programs, which enjoy
                                      a high satisfaction rate.
                                        Last spring, I was pleased to see the Centers for Medicare and Medicaid Services
                                      (CMS) relax previous telehealth restrictions in Medicare to allow high-risk individ-
                                      uals more options for care, including allowing diagnoses obtained via telehealth to
                                      be used for risk adjustment in MA and PACE. However, CMS’s guidance requires
                                      a video component to validate any diagnosis for risk adjustment purposes, even
                                      though many beneficiaries and participants have received care via audio-only visits
                                      during the pandemic, due in part to broadband and technological access gaps. Ac-
                                      cording to some surveys, the majority of seniors who have access to a cell phone lack
                                      smartphone capabilities, and for many older Americans living in rural areas, includ-
                                      ing more than 27 percent of South Carolinians, broadband hurdles persist, making
                                      audio-visual visits challenging for many beneficiaries.
                                        I have heard from plans, providers, and researchers from across South Carolina
                                      that audio-only services have accounted for a substantial portion of telehealth serv-
                                      ices during the pandemic emergency, and lower-income patients disproportionately
                                      utilize audio-only telehealth over both in-person and video telehealth services. Ac-
                                      cording to CMS’s data, only 65 percent of beneficiaries making less than $25,000
                                      have access to any Internet service in their homes.
                                        Disqualifying diagnoses obtained via audio-only telehealth services, especially for
                                      chronic conditions that have been previously documented, will result in inaccurate
                                      and incomplete documentation for MA and PACE risk adjustment purposes, arbi-
                                      trarily reducing risk scores. This could lead to unequal access, fewer choices, higher
                                      premiums, or reduced benefits for seniors and individuals with disabilities.
                                         Notably, CMS has taken the opposite approach for insurers participating in the
                                      Department of Health and Human Services (HHS)-operated risk adjustment pro-
                                      gram in the commercial market. On April 27th and August 3, 2020, the Center for
                                      Consumer Information and Insurance Oversight (CCIIO) published sets of fre-
                                      quently asked questions (FAQs) clarifying that HHS will allow diagnosis codes from
                                      audio-only telehealth services for risk adjustment purposes in 2020. On March 24,
                                      2021, CCIIO issued updated FAQs stating that the policy would continue for 2021.
                                      The same logic underlying the exchange policy should justify the application of these
                                      flexibilities to MA and PACE risk adjustment as well.
                                        If confirmed, can you commit to thoroughly reviewing this policy within the agen-
                                      cy to ensure consistency, parity, and alignment between departments and programs
                                      regarding audio-only telehealth and risk adjustment in the future?
                                        The deadline for plan bid submission for 2022 is less than 2 months away. Will
                                      you commit to working with my office and other interested offices on this issue to
                                      prevent adverse impacts for MA beneficiaries and PACE participants through re-
                                      duced benefits, higher costs, or fewer choices next year?
                                        I understand and share potential concerns about beneficiary, participant, and tax-
                                      payer protections around fraud, waste, and abuse. For that reason, I have partnered
                                      with Senator Cortez Masto to introduce bipartisan legislation including numerous
                                      guardrails to prevent potential misuse. Will you commit to working with us on The
                                      Ensuring Parity in Medicare Advantage for Audio-Only Telehealth Act of 2021 by
                                      providing technical assistance for congressional action or looking to it as a potential
                                      guide for implementing policy changes within the agency?
                                        Answer. Medicare Advantage serves millions of Americans and is an important
                                      option for Medicare beneficiaries. During the pandemic, we have been able to see
                                      the value telehealth brings for patients, including those enrolled in Medicare Advan-
                                      tage. If confirmed, I look forward to working with you to ensure that beneficiaries
                                      enrolled in Medicare Advantage plans can continue to benefit from these services.




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                                                                           ON PENDING DME RULE

                                        Question. Last year, CMS issued a Durable Medical Equipment (DME) proposed
                                      rule that would make the 50/50 blended rate for rural areas permanent. Rural ac-
                                      cess to services and care has been a longtime priority for me, given that more than
                                      one-fourth of South Carolinians live in rural areas. The proposed rule would also
                                      create a pathway for drugs requiring health-care professional administration to be
                                      covered for home infusion, helping to address an urgent challenge that the pandemic
                                      has exacerbated.
                                         I appreciate all of the work that CMS has undertaken thus far regarding the
                                      Medicare Durable Medical Equipment benefit, and we appreciate the agency’s en-
                                      gagement with stakeholders regarding refinements to this and other rules.
                                         Can you commit, if confirmed, to working to finalize the DME rule as efficiently
                                      as practicable?
                                         Answer. I recognize that rural areas have unique needs and challenges, including
                                      access to durable medical equipment. If I am fortunate enough to be confirmed, I
                                      am happy to look into the status of this regulation and work with you and your of-
                                      fice on this important issue.
                                                                    ON MEDICAID WORK REQUIREMENTS

                                         Question. A report on health equity that you co-authored last year criticized work
                                      requirements and the Trump administration’s public charge rule, writing that both
                                      policies ‘‘disproportionately impact people of color’’ and ‘‘perpetuate historic struc-
                                      tural inequities and widen the health equity gap.’’ The report described both as ‘‘dis-
                                      criminatory policies.’’
                                         In 1996, bipartisan majorities in both chambers of Congress voted to pass the Per-
                                      sonal Responsibility and Work Opportunity Reconciliation Act (PRWORA), which
                                      President Clinton signed into law, authorizing work requirements for a number of
                                      safety-net programs. As Democrats and Republicans who supported the legislation
                                      at the time explained, these requirements aimed to encourage self-sufficiency and
                                      promote opportunity. What did you mean, last year, when you described work re-
                                      quirements as ‘‘discriminatory,’’ and do you stand by that assessment?
                                         Do you believe in the core principle of welfare-to-work—namely, that workforce
                                      entry or reentry provides the ideal avenue out of poverty and dependency?
                                         Answer. Medicaid is an important lifeline for many American families. Section
                                      1115 demonstration projects, or waivers, are one available tool to States to help test
                                      new and innovative policies in Medicaid. I have worked closely with States through-
                                      out my career, so I know they face different challenges and need consistency and
                                      predictability. If confirmed, I will keep in mind what I have learned working on be-
                                      half of States to make sure waiver requests are appropriately evaluated while giving
                                      them consistent guidance. I will support State innovation and the ability of States
                                      to test out different models that meet the objectives of the Medicaid program. I look
                                      forward to seeing the ideas States bring to the table and will consider each one on
                                      its merits.
                                                                   ON SUPPORT FOR NURSING HOME I–SNPS

                                        Question. As you know, Institutional Special Needs Plans (I–SNPs) are a type of
                                      Medicare Advantage plan where the only beneficiaries enrolled are seniors living in
                                      nursing homes. When nursing homes offer these plans, they are 100-percent at risk
                                      for all the care their residents need, either at their facilities or elsewhere. In the
                                      push towards value-based care, nursing homes taking on risk via I–SNPs are doing
                                      exactly what we want to see, but in 2020, being 100 percent at risk for a population
                                      exclusively made up of the individuals most vulnerable to COVID–19, and most like-
                                      ly to need high-cost hospitalization, created serious financial challenges for nursing
                                      homes with I–SNPs, including numerous communities in South Carolina. While
                                      nursing homes in general have received funds from the Provider Relief Fund (PRF),
                                      neither HHS nor CMS has provided relief to address the specific challenges nursing
                                      home I–SNPs have faced in order to ensure this model’s continued viability.
                                        Will you commit to using administrative authority to support I–SNPs and to rec-
                                      ognize the significant increased and unexpected costs that these plans have faced
                                      during the COVID–19 emergency?
                                        Answer. It has been heartbreaking to see how hard the COVID–19 pandemic has
                                      affected the Nation’s nursing home residents. Nursing home care will absolutely be




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                                      a focus of mine if confirmed. Medicare Advantage serves millions of Americans, and
                                      Institutional Special Needs Plans provide important options for people in need of
                                      the level of care provided in nursing homes and long-term care facilities. This pan-
                                      demic has given us the opportunity to take in lessons across a variety of issues.
                                      Moving forward, it is critical we examine every approach we can to improve afford-
                                      ability, quality, and access in long-term care. If confirmed as CMS Administrator,
                                      I look forward to working with you and other members of Congress to find ways
                                      to achieve this important goal.
                                                                                   ----
                                                           QUESTIONS SUBMITTED BY HON. JAMES LANKFORD
                                         Question. Biosimilar medicines are projected to save more than $100 billion in the
                                      next 4 years and increase patient access to lifesaving medicines. Recent analysis
                                      found roughly 40 percent of first generics are not covered under Part D 3 years after
                                      launch. Over the last 10 years, generic medicines have been increasingly placed on
                                      higher cost-sharing tiers in Medicare Part D. I have been an advocate for the cre-
                                      ation of a specialty tier to provide lower cost-sharing for biosimilars and specialty
                                      generics.
                                         What steps could CMS take to encourage the use of lower-cost biosimilars and
                                      generics?
                                         Will you work with Congress to ensure generics are covered soon after launch and
                                      seniors are provided rapid access to these lower-cost medicines?
                                         Will you work to reverse the trends of generics being placed on the inappropriate
                                      Part D tier in order to ensure patient access to low-cost generics with low cost shar-
                                      ing?
                                         Answer. Prescription drug costs are too high for American patients and families.
                                      From the meetings I have had with Senators in recent weeks, I have seen that low-
                                      ering drug prices is a priority on both sides of the aisle. I agree that patient access
                                      to lower-cost generics and biosimilars is important. Competition in the market has
                                      helped control the growth in spending on prescription drugs, and generics bio-
                                      similars certainly have a role to play in creating competition for reference products.
                                      If I am fortunate enough to be confirmed, I look forward to working with you and
                                      other members of Congress to lower the cost of prescription drugs.
                                         Question. I recently sent a letter to GAO alongside many of my colleagues asking
                                      for an investigation into some recent reports on fraud in the Medicaid program.
                                         What holes in the system did you see when you worked as a program analyst for
                                      Medicaid, and what possible solutions do you look toward to help solve the problem?
                                         Answer. Fighting fraud and abuse is so important for maintaining a strong Med-
                                      icaid program. Medicaid is a critical lifeline for beneficiaries across the country. If
                                      I am fortunate enough to be confirmed, I will be prepared to work with you, other
                                      members of Congress, and States to make sure that payments are made properly
                                      and we are good stewards of the Medicaid program and taxpayer dollars.
                                         Question. The pandemic has underscored the importance of managing and pre-
                                      venting chronic disease and removing health disparities. We also recognize that
                                      higher out-of-pocket costs correlate with less prescription drug access. To this end,
                                      we need to be proactive and address system challenges that inadvertently drive out-
                                      of-pocket costs up for seniors. For example, certain system fees, called DIR fees, lead
                                      to increased costs for seniors at the pharmacy counter, while also threatening the
                                      viability of pharmacies across the Nation, leading to gaps in care. As you are aware,
                                      the Centers for Medicare and Medicaid Services (CMS) has estimated that phar-
                                      macy DIR fee reform could result in saving Medicare beneficiaries between $7.1 and
                                      $9.2 billion in cost sharing burden over the next decade.
                                         To reduce out-of-pocket costs for seniors and safeguard access to care provided at
                                      local pharmacies, how will you commit to DIR fee claw-back reform and the estab-
                                      lishment of standardized performance measures for pharmacies in Part D to help
                                      drive quality for seniors and control rising costs?
                                         Answer. Small and rural pharmacies are critical to our Nation’s health-care sys-
                                      tem and have been especially important during the pandemic. It can be hard for
                                      these pharmacies to predict retroactive DIR fees. We must do all we can to ensure
                                      that Americans can access important health-care services, including from local phar-
                                      macies in their communities. If confirmed, I look forward to working with Congress
                                      to ensure that pharmacies have predictability.




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                                         Question. As you know, the Medicare Advantage institutional special needs pro-
                                      gram is an important source of personalized support for long-term care residents.
                                      It has proven to deliver quality care with supplemental benefits at a lower cost. As
                                      a result, Congress has seen the value and made the I–SNP program permanent.
                                      Since I–SNPs only serve long-term care populations, they cannot shift the risks they
                                      may assume. One of these plans is currently servicing several of the long-term care
                                      facilities in Oklahoma and, unsurprisingly, the COVID pandemic has had a particu-
                                      larly devastating effect on them, as nursing home residents continue to be on the
                                      front lines of those most negatively impacted. Special needs plans have fallen
                                      through the cracks of COVID support and have been subject to unintended con-
                                      sequences, leading to enrollment disincentives and further increasing the pressure
                                      on I–SNPs.
                                         Do you acknowledge that the I–SNPs are facing a significant problem?
                                         If so, will you commit to working with the struggling plans to address the dispari-
                                      ties they currently face, ensuring there are equitable private options available for
                                      nursing home residents, and finding a solution?
                                         If not, please explain why.
                                         Answer. It has been heartbreaking to see how hard the COVID–19 pandemic has
                                      affected the Nation’s nursing home residents. Nursing home care will absolutely be
                                      a focus of mine, if confirmed. Medicare Advantage serves millions of Americans, and
                                      Institutional Special Needs Plans provide important options for people in need of
                                      the level of care provided in nursing homes and long-term care facilities. I agree
                                      that it is critical we examine every approach we can to improve affordability, qual-
                                      ity, and access in long-term care. If confirmed as CMS Administrator,
                                         I look forward to working with you and other members of Congress to find ways
                                      to achieve this important goal.
                                         Question. Your career has focused on expanding health coverage for Americans.
                                         If confirmed, do you plan to increase the role of the Federal Government in health
                                      care by promoting a public option? Please detail your plans for expanded health cov-
                                      erage.
                                         Answer. President Biden has been clear that his goals for improving the American
                                      health-care system begin with building on the successes of the Affordable Care Act,
                                      and I am committed to working toward that goal. Ensuring that all Americans have
                                      access to affordable, quality health care will be a priority of mine. I want to work
                                      with States to expand coverage through Medicaid and the Marketplaces. I look for-
                                      ward to working with you to expand access to affordable, quality health care.
                                                                                   ----

                                                             QUESTIONS SUBMITTED BY HON. STEVE DAINES
                                         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. Telehealth has truly taken root,
                                      and we have seen exponential growth in telehealth adoption across Americans of all
                                      ages, locations and conditions. Much of the growth in usage among Medicare bene-
                                      ficiaries 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.
                                         Do you agree that the expanded access to telehealth services has been an impor-
                                      tant component in protecting patients and providers during the Nation’s response
                                      to COVID–19?
                                         As Congress considers permanent telehealth reform, I hope you will be willing to
                                      work with us to ensure that telehealth is available to all of those that wish to use
                                      it. Do you believe that there are some telehealth regulatory restrictions that Con-
                                      gress and CMS can work together to address in the near term?
                                         Answer. Telehealth has been invaluable during this pandemic to keep patients,
                                      their providers and their families safe. My brother is a psychologist, and telehealth
                                      has really helped his patients get the care they need. If I am fortunate enough to
                                      be confirmed, I will be taking a careful look at the telehealth flexibilities under
                                      Medicaid and Medicare before the Public Health Emergency ends.




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                                        I want to look at what we can and should extend administratively and what will
                                      need congressional action to ensure that we bring the lessons learned about tele-
                                      health during the pandemic into our health-care system going forward. I look for-
                                      ward to hearing more from you about what existing flexibilities you view as espe-
                                      cially important.
                                         Question. Emerging science indicates that addressing risk factors—including car-
                                      diovascular disease, diabetes, obesity, and hypertension—can delay the onset of de-
                                      mentia and Alzheimer’s. However, we continue to see our health-care system, par-
                                      ticularly Medicare, fail to pursue low-cost, effective policies to reduce the risk for
                                      chronic conditions, including Alzheimer’s. Instead, our system waits until people are
                                      sick and treatment costs are significantly higher.
                                        If confirmed, how will CMS pursue wellness and early intervention policies that
                                      reduce the risk of chronic diseases like Alzheimer’s?
                                        Answer. Alzheimer’s disease is a devastating condition for patients and families.
                                      It is only going to be a growing challenge for the Medicare program and our aging
                                      population in coming years. Preventive care is crucial to improving health outcomes,
                                      and it is so important to catch the signs of cognitive impairment early. I’d be happy
                                      to work with you on this should I be confirmed.
                                        Question. Late last year, CMS issued a Durable Medical Equipment proposed rule,
                                      which would make the 50/50 blended rate for rural areas permanent. This rule has
                                      not been made final as of yet. I appreciate all the work HHS and CMS have done
                                      regarding the Medicare Durable Medical Equipment benefit.
                                           When will HHS and CMS issue the final DME rule?
                                         Answer. I recognize that rural areas have unique needs and challenges, including
                                      access to durable medical equipment. If I am fortunate enough to be confirmed, I
                                      am happy to look into the status of this regulation and work with you and your of-
                                      fice on this important issue.
                                        Question. The coronavirus pandemic has underscored the value of vaccines for in-
                                      fectious diseases, including those that originate abroad. We all recognize that
                                      COVID–19 will not be the last time we have to respond to an outbreak for which
                                      vaccinations are necessary in order to stem an emerging public health threat.
                                         Public policy should make vaccines as accessible as possible for our citizens. That
                                      is why current law requires that insurers provide coverage without cost sharing for
                                      all recommended vaccines, without limitation.
                                        Yet, inexplicably, current HHS regulations implementing the law limit mandatory
                                      coverage to so-called ‘‘routine’’ vaccines on the Immunization Schedules. As a result,
                                      many vaccines for infectious diseases are not covered without cost-sharing, including
                                      those for current vaccines such as rabies, anthrax, Japanese Encephalitis, yellow
                                      fever and cholera, and those vaccines in the pipeline for malaria, chikungunya, den-
                                      gue, and Zika.
                                        Last year, my colleagues and I worked on bipartisan legislation included in the
                                      CARES Act that ensures immediate coverage of COVID–19 vaccines with no cost-
                                      sharing. As I said then, Montanans and Americans across the country need access
                                      to vaccines, and financial barriers should not stand in the way during a national
                                      emergency or otherwise.
                                         Congress should not have had to be reactive. A forward-looking, uniform approach
                                      is needed to ensure that we are prepared to move quickly on vaccinations when the
                                      next pandemic occurs.
                                        If confirmed, will you commit to quickly bringing agency regulations in line with
                                      the statute requiring no cost-sharing for all CDC recommended vaccines to maxi-
                                      mize access to the best preventative measures against infectious diseases?
                                        Answer. I agree that the COVID–19 pandemic has underscored the importance of
                                      vaccines to preventing the spread of disease, and I agree that we should remove bar-
                                      riers for patients to get proven vaccines. We need to be prepared for any potential
                                      future outbreak, and I agree we cannot afford to be reactive on such an important
                                      issue. I am happy to work with you to ensure we are ready for the next public
                                      health emergency.




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                                                             QUESTIONS SUBMITTED BY HON. TODD YOUNG
                                                        CENTER FOR MEDICARE AND MEDICAID INNOVATION (CMMI)

                                        Question. The Center for Medicare and Medicaid Innovation (CMMI) is charged
                                      with testing and evaluating voluntary healthcare payment and service delivery mod-
                                      els with the intent of increasing quality and efficiency while reducing program ex-
                                      penditures under Medicare, Medicaid, and the Children’s Health Insurance Program
                                      (CHIP).
                                        As we discussed during our meeting, I feel there is absolute value in innovating
                                      with health-care payment and service delivery systems. We won’t know if we’re
                                      truly making a difference unless we test and evaluate—it’s how we find out what
                                      works and what’s most effective for patients and doctors alike.
                                        However, the actual experience of CMMI can too often be marked by a lack of
                                      transparency and little stakeholder engagement in the development and implemen-
                                      tation of models.
                                         At times, models also seem to initiate wholesale policy changes rather than serve
                                      as true tests, circumventing Congress’s role in establishing Medicare policy. I also
                                      want to ensure that proposed models sufficiently take into consideration the poten-
                                      tial health-care access disparities for vulnerable populations.
                                        Will you work with the members of this committee on establishing protections to
                                      guarantee better transparency, stakeholder input, data sharing, and equity in the
                                      development of proposed models by CMMI?
                                        Will you commit to come back to this committee to share updates and release
                                      progress reports on CMMI actions and models?
                                        Answer. The Innovation Center has been an important tool to test new models
                                      to move our health-care system from one that rewards volume to one that rewards
                                      value. It will continue to be important, as we move forward, to test models that im-
                                      prove patient care, advance health equity, and lower patient costs. We have now
                                      had 10 years of experience to learn from at the Innovation Center. We need to look
                                      at what has worked and what hasn’t and chart a path forward from there. This in-
                                      cludes getting stakeholder input, and if I am fortunate enough to be confirmed, it
                                      will be a priority for me to have open lines of communication with Congress. I look
                                      forward to hearing from you about CMMI models.
                                                                                 TELEHEALTH

                                        Question. Even prior to the pandemic, I heard from my constituents in Indiana—
                                      particularly those in rural areas—about the ways in which telehealth can both in-
                                      crease access to underserved Americans and reduce health-care costs. Since the
                                      start of the public health emergency, telehealth flexibilities provided by Congress
                                      and HHS have been a lifeline for vulnerable seniors and others accessing care from
                                      the safety of their own homes.
                                        Currently, authorizations included in the CARES Act to create additional flexi-
                                      bility for patients and providers using telehealth only extend through the pandemic.
                                        We don’t want to take a step back on telehealth. The Medicare Payment Advisory
                                      Commission (MedPAC) has recommended that we should ‘‘temporarily continue
                                      some of the telehealth expansions for a limited duration of time (e.g., 1 or 2 years
                                      after the public health emergency) to gather more evidence about the impact of tele-
                                      health on beneficiary access to care, quality of care, and program spending to inform
                                      any permanent changes.’’ What data or evidence is CMS collecting now to determine
                                      what waivers should be made permanent?
                                        How should telehealth be used moving forward to expand access to mental and
                                      behavior health services for Medicare beneficiaries?
                                        Answer. Telehealth has been invaluable during this pandemic to keep patients,
                                      their providers and their families safe. My brother is a psychologist, and telehealth
                                      has really helped his patients get the care they need. If I am fortunate enough to
                                      be confirmed, I will be taking a careful look at the telehealth flexibilities under
                                      Medicaid and Medicare before the Public Health Emergency ends to determine what
                                      we can extend administratively and what we will need Congress’s help on to ensure
                                      that we use the lessons learned about telehealth during the pandemic to modernize
                                      our health-care system.




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                                                                           ORGAN PROCUREMENT

                                        Question. Thirty-three Americans die every day waiting for a lifesaving organ
                                      transplant, and Medicare spends roughly $36 billion annually on care for dialysis
                                      patients because there are not enough kidney transplants available to meet the
                                      need. The problem is a network of unaccountable government monopoly contractors
                                      that run the organ donation system, called organ procurement organizations
                                      (OPOs), with a history of severe performance failure.
                                        Recently, CMS finalized a rule started in the previous administration that would
                                      allow HHS to replace failing OPOs with high performers, and is projected to save
                                      more than 7,000 additional lives every year, as well as over $1 billion annually to
                                      Medicare.
                                        This rule has broad bipartisan support, and is even more important since COVID–
                                      19 damages organs. As CMS Administrator, will you commit to its swift implemen-
                                      tation?
                                        Answer. Thank you for bringing up this important issue. Federal law tasks CMS
                                      with conducting surveys of OPOs and recertifying them. As you noted, the rule re-
                                      placing current OPO measures with new transparent, reliable, and objective out-
                                      come measures is now effective. My understanding is that the new outcome meas-
                                      ures will be implemented on August 1, 2022, the start of the next recertification
                                      cycle. If confirmed, I will work to implement this rule in a timely way and ensure
                                      that all parts of the organ transplant system are as effective and efficient as pos-
                                      sible in order to save as many lives as possible.
                                                                           MEDICARE ADVANTAGE

                                        Question. We have seen a growth in the private/public partnership program in
                                      Medicare Advantage (MA). Over 40 percent of Medicare beneficiaries are choosing
                                      Medicare Advantage and they report high satisfaction with the provider networks,
                                      cost savings and coordinated care.
                                       What role do you see Medicare Advantage having in the future of Medicare as
                                      we work towards modernizing the program?
                                        Medicare Advantage is showing that it can provide lower consumer costs, offer ad-
                                      ditional benefits, and achieve better outcomes, like fewer avoidable hospitalizations
                                      including for high need, high risk patients for the same or lower cost as FFS Medi-
                                      care.
                                        Research from UnitedHealth Group shows that Hoosiers enrolled in a Medicare
                                      Advantage plan spend nearly $1,800 less on premiums and out-of-pocket costs than
                                      a Hoosier enrolled in traditional Medicare and a prescription drug plan; and, in ad-
                                      dition to the dental, vision, and hearing benefits typically offered, the average MA
                                      beneficiary in Indiana receives $170 annually in additional benefits such as care co-
                                      ordination, meals, and non-emergency transportation not offered by traditional
                                      Medicare.
                                       Do you see Medicare Advantage as an important part of modernizing Medicare
                                      while getting better results for our taxpayer dollars?
                                        What will you do to protect this public/private partnership and keep the program
                                      strong?
                                        Answer. Medicare Advantage serves millions of Americans and is an important
                                      option for Medicare beneficiaries. I believe that we have to take every approach we
                                      can to provide people access to quality health care. If confirmed as CMS Adminis-
                                      trator, I look forward to working with Congress on this important issue.
                                                                    SEPSIS TESTING STANDARD OF CARE

                                        Question. More than 20 million Americans present with symptoms of sepsis in
                                      acute care hospitals annually, and are treated under a ‘‘sepsis protocol’’ where blood
                                      culture tests are urgently drawn to diagnose bloodstream infections. However, ap-
                                      proximately 40 percent of these blood culture tests are false positives. This results
                                      in patients being subjected to extended hospital stays and the unnecessary use of
                                      potent antibiotics, which have been proven to contribute to the spread of antibiotic
                                      resistance.
                                        What is CMS doing to ensure that hospitals across the country are working to
                                      reduce their false positive sepsis test rates to ensure patient safety?




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                                        Answer. Thank you for raising this important issue. Timely diagnosis and treat-
                                      ment of sepsis is a critical issue as are actions that will enhance antibiotic steward-
                                      ship. If confirmed, I look forward to working with you to continuously improve the
                                      quality of care that hospitals are providing to patients, including with respect to ac-
                                      curately diagnosing sepsis while avoiding unnecessary use of antibiotics.
                                                                     END STAGE RENAL DISEASE (ESRD)

                                         Question. Last November, my staff shared some concerns we heard from rep-
                                      resentatives of the kidney care community about the proposed methodology to incor-
                                      porate certain drugs into the ESRD bundle. There have been reports of dialysis pa-
                                      tients on these therapies being forced off treatments that are working for them onto
                                      therapies that have not worked for the patient in the past.
                                        As CMS Administrator, how you will ensure patient quality of care is not being
                                      impacted—specifically for communities of color who are disproportionately impacted
                                      by kidney disease—so that patients can continue to access these medicines best suit-
                                      ed for their treatment?
                                         Answer. I agree that is it important for Medicare beneficiaries, particularly pa-
                                      tients with complex conditions such as ESRD, to have access to medically necessary
                                      treatments. Promoting health equity—particularly for communities of color and
                                      rural areas—needs to be at the forefront of CMS decision making. If confirmed, I
                                      will work to preserve access to these treatments in Medicare and improve patient
                                      outcomes.

                                                                                   ----
                                                               QUESTIONS SUBMITTED BY HON. BEN SASSE
                                                                                 TELEHEALTH

                                         Question. While my colleagues have pointed out many of the ways COVID–19 has
                                      challenged our health-care system and exposed existing inequities, one bright spot
                                      in the pandemic has been increased access to telehealth services as a way for pa-
                                      tients to maintain their health from the safety of their homes. This has been par-
                                      ticularly important for States like Nebraska with large areas of rural population.
                                         We know that CMS has allowed expanded use of audio-only services during the
                                      pandemic, but how is CMS working to ensure that those without broadband access
                                      can utilize appropriate telehealth services in a post-pandemic world?
                                         Where do you stand on audio-only telehealth coverage? What about on payment
                                      parity between in-person and virtual services?
                                         How will you approach geographic restrictions, both in patient location and pro-
                                      vider licensure?
                                         If confirmed, how do you plan to evaluate the use of telehealth over the last year
                                      and the places where it should—and potentially should not—be expanded beyond
                                      the end of the national emergency period?
                                         Answer. Telehealth has been invaluable during this pandemic to keep patients,
                                      their providers, and their families safe. My brother is a psychologist, and telehealth
                                      has really helped his patients get the care they need. If I am fortunate enough to
                                      be confirmed, I will take a careful look at the telehealth flexibilities under Medicaid
                                      and Medicare before the Public Health Emergency ends. During that review, I will
                                      pay special attention to the issues of equity and access. I will look at what we can
                                      and should extend administratively and where we will need Congress’s help to en-
                                      sure that we bring the lessons learned about telehealth during the pandemic for-
                                      ward to modernize our health-care system.
                                         Question. Individuals with chronic disease place an immense strain on our health-
                                      care system and account for a huge percentage of the overall costs to taxpayers. I
                                      think you would agree that early identification and treatment is crucial not only
                                      among those with chronic diseases but in our health systems in general. Remote pa-
                                      tient monitoring (RPM) can be beneficial in managing both acute and chronic condi-
                                      tions and identifying deteriorations in health as early as possible to allow for the
                                      best level of care. Issues with reimbursement continue to constrain Medicare recipi-
                                      ents’ access to this level of monitoring.
                                         Do you see value in increased access to remote patient monitoring and what are
                                      your views on the co-pay requirement for these services?




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                                         Answer. 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 bene-
                                      ficiaries who may benefit from these and other virtual services that allow their phy-
                                      sicians to help manage and treat their health conditions outside of regular office vis-
                                      its.
                                                                       MOST FAVORED NATION MODEL

                                         Question. I have concerns with the Most Favored Nation model rulemaking, both
                                      with the policy of tying Medicare reimbursements to the prices foreign countries pay
                                      and with the creation of the expansive rule through the Center for Medicare and
                                      Medicaid Innovation (CMMI) under the guise of being a pilot program.
                                         If confirmed, how will you approach this policy? Do you support tying the prices
                                      of American drugs to foreign prices?
                                         Will you commit to ensuring that CMMI is used as intended rather than as a con-
                                      gressional workaround?
                                         Answer. Prescription drug costs are too high for American patients and families.
                                      From the meetings I have had with Senators in recent weeks, I have seen that this
                                      is a priority on both sides of the aisle. I think there is an opportunity for real impact
                                      here to lower prescription drug costs, and—if I am fortunate enough to be con-
                                      firmed—I look forward to working with you and other members of Congress to
                                      achieve that goal.
                                         Regarding the Center for Medicare and Medicaid Innovation, the Innovation Cen-
                                      ter has been an important tool to test new models to move our system from one that
                                      rewards volume to one that rewards value. It will continue to be important, as we
                                      move forward, to test models that improve patient care, advance health equity, and
                                      lower patient costs. With 10 years of experience to learn from at the Innovation
                                      Center, we need to look at what has worked and what hasn’t, and I look forward
                                      to hearing from you about what you think is working well and what experiences
                                      you’ve seen on the ground in Nebraska.
                                                                                   MEDICAID

                                         Question. Enrollment in the Medicaid program has exploded during the pandemic,
                                      partially due to problematic language in last year’s relief bills where States have
                                      no choice but to provide services even to people who are not actually eligible for the
                                      program. The Families First Coronavirus Response Act (FFCRA) offered States an
                                      increased Federal Medical Assistance Percentage (FMAP) for their traditional Med-
                                      icaid populations and in turn restricted them from maintaining control over their
                                      Medicaid programs via maintenance-of-effort requirements. Across the country there
                                      are millions of Medicaid enrollees whose redetermination has been delayed, and in
                                      just seven States where we have data we know that roughly half a million enrollees
                                      are receiving benefits who are ineligible for the program.
                                         Do you commit to working with States and Congress to actually identify which
                                      enrollees are eligible and which are not?
                                         Do you commit to making sure that the Medicaid program is able to serve those
                                      individuals who are truly in need?
                                         Do you believe States should have the right to remove ineligible enrollees, which
                                      is currently restricted by FFCRA?
                                         Answer. Medicaid is a critical lifeline for beneficiaries across the country. If I am
                                      fortunate enough to be confirmed, I will also be prepared to work with you, other
                                      members of Congress, and States to make sure that payments are made properly
                                      and we are good stewards of the Medicaid program and taxpayer dollars. The re-
                                      quirement related to enrollment at section 6008(b)(3) of the Families First
                                      Coronavirus Response Act for States receiving the Medicaid FMAP increase will be
                                      in effect until the end of the month in which the COVID–19 public health emer-
                                      gency ends. As that time grows nearer, it will be important for CMS to work closely
                                      with States to plan for the transition.
                                                                       DURABLE MEDICAL EQUIPMENT

                                        Question. HHS and CMS have done a lot of work on the Medicare Durable Med-
                                      ical Equipment benefit, including issuing a proposed rule late last year that would
                                      have made the 50/50 blended rate for rural areas permanent.




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                                         When does CMS plan to issue the final DME rule given the change of administra-
                                      tions?
                                         Answer. I recognize that rural areas have unique needs and challenges, including
                                      access to durable medical equipment. If I am fortunate enough to be confirmed, I
                                      am happy to look into the status of this regulation and work with you and your of-
                                      fice on this important issue.
                                         Question. We know that some of our most vulnerable in society rely on ventilators
                                      for their care, yet access to new-generation, multi-function ventilators can often be
                                      restricted by complicated payment policies that have not adapted for new tech-
                                      nologies. This is particularly important in light of the pandemic, when ventilation
                                      in home care settings allows for more hospital space.
                                         If confirmed, will you work to update CMS payment regulations to account for ad-
                                      vancements in ventilator technology, including adjusting irregularities in payment
                                      that impede patient access?
                                         Answer. We know that some of our most vulnerable patients rely on ventilators
                                      for their care, yet access to new-generation, multi-function ventilators can often be
                                      impeded by statutory payment policies related to paying for equipment on a cap
                                      rental basis and the reasonable useful lifetime of the equipment. To help ensure ac-
                                      cess to ventilators in light of the COVID–19 public health emergency, I understand
                                      that CMS is allowing payment for multi-function ventilators even if separate devices
                                      have not met their reasonable useful lifetime.
                                         I agree that it is incredible what science has been able to do in recent years with
                                      innovative new drugs, treatments and devices. If I am fortunate enough to be con-
                                      firmed, I will make sure we are looking at modernizing the Medicare program to
                                      make sure beneficiaries have access to proven new technology, and I would be
                                      happy to work with you on that.
                                                                                   ----
                                                            QUESTIONS SUBMITTED BY HON. JOHN BARRASSO
                                         Question. At the end of 2020, Congress provided relief from reductions in reim-
                                      bursement to certain physicians which was included in last year’s physician fee
                                      schedule final rule. This was the result of budget neutrality requirements within the
                                      fee schedule. With many physician practices experiencing substantial challenges as
                                      a result of the COVID–19 pandemic, it is important to ensure providers are able
                                      to continue caring for patients.
                                         Can you please discuss your approach regarding future changes to the physician
                                      fee schedule? In particular your feelings on reducing reimbursements to providers
                                      during the pandemic.
                                         Answer. I believe that ensuring adequate payments for primary care and specialty
                                      physicians is essential to maintain beneficiary access to high-quality and affordable
                                      health care. If confirmed, I will work to ensure that payments under the Medicare
                                      physician fee schedule are implemented in accordance with the law while preserving
                                      beneficiary access.
                                         Question. Current law requires zero cost sharing for COVID therapeutics. How-
                                      ever, when the Public Health Emergency (PHE) is lifted many of these policies
                                      linked to the PHE declaration will no longer be in effect under the law and will po-
                                      tentially be subject to CMS’ discretion.
                                         Please discuss your approach to reimbursement for COVID therapeutics. In par-
                                      ticular your feelings on how this issue should be approach once the PHE is lifted.
                                         Answer. I appreciate Congress’s leadership in making sure that patients suffering
                                      from COVID–19 have been able to get the care they need during the public health
                                      emergency. I think we need to look at the policies in place during the pandemic and
                                      determine what we should do after the pandemic is over, either administratively or
                                      with legislation from Congress. If confirmed, I will be happy to work with you and
                                      other members of Congress as we look beyond the pandemic.
                                         Question. Drugs approved via accelerated approval at the Food and Drug Admin-
                                      istration (FDA) are novel treatments that address urgent and unmet medical needs
                                      involving serious and life-threatening diseases.
                                         As a doctor, I am particularly passionate about the new treatments approved
                                      through this pipeline to treat Duchenne Muscular Dystrophy. As you know, this is
                                      a deadly disease, which until very recently had no approved treatments. Today we




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                                      have five treatments approved through this pathway with many more in develop-
                                      ment. While certainly not a cure, these therapies are an important step forward.
                                        Recently, the Medicaid and CHIP Payment and Access Commission (MACPAC)
                                      issued recommendations to increase the required Medicaid rebates for drugs specifi-
                                      cally approved through the accelerated pathway.
                                         While I appreciate that MACPAC is a congressional advisory body, I believe their
                                      recommendation to single out these therapies is troubling. In particular, when you
                                      consider medications approved in this manner treat some of our most vulnerable pa-
                                      tients and make up a very small percentage of total Medicaid spending.
                                       Can you discuss your views on Federal reimbursement policies on the develop-
                                      ment of new therapies for people with rare diseases?
                                         Answer. Thank you for raising this important issue. It is incredible what scientific
                                      progress has been made with innovative drugs and treatments, and we need to con-
                                      tinue to modernize the Medicare and Medicaid programs to make sure beneficiaries,
                                      including those with rare diseases, have access to proven new treatments. If con-
                                      firmed, I would be happy to examine this particular MACPAC proposal in more de-
                                      tail, and to work with you and other members of Congress on ways to spur innova-
                                      tion and facilitate beneficiary access to new advances in medicine.
                                        Question. Last year I led a bipartisan letter with Senate and House colleagues to
                                      CMS expressing concerns about cuts to hip and knee replacement in the Calendar
                                      Year 2021 (CY21) Physician Fee Schedule and the implications for value based care.
                                        Specifically, the letter urged CMS to recognize the patient preoptimization work
                                      physicians are doing in alternative payment models. The CY’21 rule substantially
                                      cut lower joint arthroplasty even though physicians performing those procedure are
                                      doing more work and saving the Medicare Trust Funds money through their record-
                                      high participation in alternative payment models (APMs).
                                        These cuts are concerning. This appears to be a disconnect between the legacy fee-
                                      for-service evaluation of procedures, and innovative care we are encouraging in
                                      APMs. However, the Final Rule indicated CMS’s interest in capturing this patient
                                      preoptimization work.
                                           Would you please work with the stakeholders and I on the preoptimization issue?
                                        More broadly, can you discuss your feeling on alternative payment models and if
                                      there are specific areas where you wish to focus?
                                        Answer. I agree that we should continue efforts to further move our health-care
                                      system towards one that rewards value over volume. Delivery system reform efforts,
                                      including alternative payment models, can improve quality of care while reducing
                                      health-care costs. The Innovation Center has been an important tool to test new
                                      models to move our system from one that rewards volume to one that rewards
                                      value. It will continue to be important, as we move forward, to test models that im-
                                      prove patient care, advance health equity, and lower patient costs. We have now
                                      had 10 years of experience to learn from at the Innovation Center. We need to look
                                      at what has worked and what hasn’t, and if confirmed, I will work with you to make
                                      sure we recognize the good work providers are doing to move our system in the right
                                      direction, improve care, and lower Medicare spending.
                                        Question. I support price transparency in the health-care system. The Trump ad-
                                      ministration made good progress on this problem with their hospital price trans-
                                      parency rule, which went into effect on January 1, 2021.
                                        It appears from media reports that many hospitals are not following the rule. If
                                      confirmed, how will you address price transparency in health care, especially in
                                      terms of enforcement of the price transparency rule?
                                         Answer. I agree that the variation in pricing across hospitals is not always justi-
                                      fied and ultimately can be bad for consumers. For transparency measures to work
                                      properly, patients and their families must be able to understand them in a meaning-
                                      ful way. If I am fortunate enough to be confirmed, I look forward to continuing to
                                      work on this issue.




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                                                                                      103
                                                              PREPARED STATEMENT OF HON. MIKE CRAPO,
                                                                    A U.S. SENATOR FROM IDAHO

                                        When we held our hearing for Xavier Becerra to be the Secretary of Health and
                                      Human Services, I noted the size and importance of the Department he would lead.
                                      In normal times, HHS and its agencies provide health-care coverage to nearly 150
                                      million people, and those agencies affect the lives of many more on a daily basis.
                                      The COVID–19 pandemic has raised the salience of the Department.
                                        The Department’s leadership, including the Deputy Secretary, will continue to
                                      play a key role in bringing us out of the public health emergency. Similarly, Medi-
                                      care and Medicaid are providing essential health care to patients who have suffered
                                      disproportionately from the COVID–19 pandemic.
                                         Looking to the future, the Secretary, the Deputy Secretary, and the CMS Admin-
                                      istrator must carefully evaluate how best to use the resources available to them to
                                      promote the health care of our citizens. They must do so carefully, constructively,
                                      and creatively.
                                        Two months ago, I outlined several issues in the health-care space where I intend
                                      to focus my efforts as ranking member, including fostering innovation to improve
                                      patient care and make our health-care system more efficient. The COVID–19 pan-
                                      demic has threatened Americans’ physical and economic health, but it has also rein-
                                      forced the value of innovation and provided an opportunity to test changes that fos-
                                      ter it.
                                        HHS has used its authority under the public health emergency to waive numerous
                                      requirements to ensure Medicare and Medicaid beneficiaries and other patients re-
                                      ceive care during the pandemic. Patients and providers have benefited from ex-
                                      panded access to telehealth and expedited approval of COVID–19 vaccines, diag-
                                      nostics, and treatments. Going forward, Medicare and Medicaid patients must have
                                      the same access to innovative items and services as those with commercial insur-
                                      ance.
                                        We must carefully evaluate our response to the pandemic and implement appro-
                                      priate reforms based on the lessons we have learned. HHS should partner with this
                                      committee in that effort. However, media reports about certain health-care policies
                                      that may come before Congress or be enacted through executive actions are con-
                                      cerning. Some of these policies, such as including additional benefits under Medi-
                                      care, could experience bipartisan support if considered through a transparent, coop-
                                      erative process.
                                        Unfortunately, reconciliation does not afford Congress the opportunity to work to-
                                      gether to evaluate these changes and make necessary reforms to protect the long-
                                      term financial viability of the program. Other policies, such as expanding Obama-
                                      care’s premium subsidy to everyone, regardless of income, would be incredibly ex-
                                      pensive for taxpayers without taking appropriate steps to lower the cost of health
                                      insurance. Creative, bipartisan ideas to lower the cost of insurance in the individual
                                      market have been raised by States and my colleagues on this committee.
                                        I welcome the opportunity to work together on some of these ideas, such as allow-
                                      ing States to use waivers to their full potential, diversifying benefit designs, and
                                      incentivizing competition.
                                        Finally, I am concerned about paying for some of these policies through changes
                                      to our drug pricing system that could stifle innovation. We can see the end of the
                                      COVID–19 pandemic approaching, thanks to groundbreaking vaccines developed by
                                      pharmaceutical manufacturers. In this crisis, industry responded to the Nation’s call
                                      to arms, code-named Project Warp Speed, developing powerful and effective vaccines
                                      in record time. This success was possible because of the private sector.
                                         I strongly agree with my colleagues that this innovation is only valuable if pa-
                                      tients can afford it. We should establish an out-of-pocket spending cap and reform
                                      Medicare Part D with the market-based principles of competition and transparency
                                      in mind.
                                        Ms. Palm and Ms. Brooks-LaSure, if you are confirmed, I look forward to working
                                      with you to improve our health-care system. I ask you to commit to careful assess-
                                      ments of the risks and considerations in every policy decision you make. Political
                                      pressures may make unilateral action seem attractive, but you should also consider
                                      how the market, individual choice, public policy, and incentives play vital roles in
                                      the development and delivery of health care.




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                                         I look forward to hearing your testimony and your responses to questions. The po-
                                      sitions to which you have been nominated have substantial influence over policy.
                                      The members of this committee need to understand how you will implement the ad-
                                      ministration’s agenda.
                                           We expect your answers, here and in response to QFRs, to be detailed and candid.

                                                                                    ----

                                              PREPARED STATEMENT OF ANDREA JOAN PALM, NOMINATED TO BE DEPUTY
                                                    SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES
                                        Thank you, Chairman Wyden, Ranking Member Crapo. I am grateful for the op-
                                      portunity to testify before you today as President Biden’s nominee for Deputy Sec-
                                      retary of the United States Department of Health and Human Services. I want to
                                      thank Senator Tammy Baldwin for the kind introduction and for her work on behalf
                                      of the people of Wisconsin. And thank you to the members of this committee for con-
                                      sidering my nomination. I’ve enjoyed the opportunity to speak with many of you in-
                                      dividually.
                                        I was born and raised in Star Lake, NY—a town of about 1,000 people. When you
                                      grow up in a small town, you understand from a young age that together is the only
                                      way to get things done. That sense of community was formative and is what led
                                      me to become a social worker. I spent my twenties as a caseworker, finding safe
                                      homes for children in crisis and working for people with behavioral health needs.
                                        These experiences shaped the rest of my career. It was the children and families
                                      I worked with during this time that made me want to change the system and drew
                                      me to public policy and public service. The memories of these kids still motivate me
                                      today.
                                        I’ve spent my entire career focused on health and human services policy and lift-
                                      ing up our most vulnerable communities, from my time in the Senate working on
                                      the HITECH Act to serving at HHS, where I played a key role implementing the
                                      Affordable Care Act and negotiating bipartisan policies like the 21st Century Cures
                                      Act.
                                        Most recently, I had the privilege of leading Wisconsin’s Department of Health
                                      Services. I’m proud of the work I was able to accomplish in Wisconsin. There, we
                                      found ways to make progress on a bipartisan basis, expanding access to telehealth
                                      services and our innovative Children’s Health Insurance Program, and improving
                                      delivery of the Departments’ programs to better serve the people of Wisconsin.
                                        And when the pandemic hit, we led with facts, science, and transparency to pro-
                                      tect our communities. As every single State did, we faced obstacles. But we built
                                      a strong State-wide response—leveraging government assets and the expertise of
                                      the private sector—to build stable testing and contact tracing programs, reach rural
                                      communities, and vaccinate Wisconsinites.
                                           And it’s working. Wisconsin is among the top States in vaccinating its residents.
                                         When I was previously at HHS, then-Secretary Burwell would joke that if there
                                      was an issue that was going to require bipartisan cooperation, the team should give
                                      it to me. She called my portfolio the ‘‘common ground agenda.’’ And if I have the
                                      honor of being confirmed and returning to HHS, that’s what I’m bringing with me:
                                      a common-ground agenda.
                                         First, we must end the COVID–19 pandemic. I know we can all agree we have
                                      lost far too many Americans to this virus. President Biden put forward ambitious
                                      goals, and Congress has followed through, providing the resources to get the job
                                      done. If confirmed, I look forward to implementing the American Rescue Plan, get-
                                      ting vaccines in arms, rebuilding a public health workforce, and securing this Na-
                                      tion’s supply chain.
                                         Second, we must expand access to high-quality, affordable health care. The Amer-
                                      ican Rescue Plan took major steps to bring down the cost of health care for working
                                      families, but we can’t stop there. We must strengthen our Medicare and Medicaid
                                      lifelines; reduce the cost of prescription drugs; better integrate mental health and
                                      substance use disorder treatment into our health-care system; maintain our global
                                      leadership in research, development and innovation; and ensure that all Americans
                                      have access to quality, affordable health care.




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                                        Finally, we must prioritize human services. HHS has an important role to play.
                                      From caring for children, to advancing the health and well-being of people with dis-
                                      abilities, we must not lose sight of these core missions.
                                        HHS faces big challenges. And it’s our responsibility to be tireless stewards of an
                                      agency that touches nearly every aspect of American life. To me, that’s what public
                                      service is all about: making government work for the people, and leaving the coun-
                                      try better than we found it.
                                        I am ready for the task, and eager to continue serving. Thank you for considering
                                      my nomination.
                                                                                   ----
                                                             SENATE FINANCE COMMITTEE

                                                  STATEMENT OF INFORMATION REQUESTED
                                                              OF NOMINEE
                                                                   A. BIOGRAPHICAL INFORMATION
                                       1. Name (include any former names used): Andrea Joan Palm.
                                       2. Position to which nominated: Deputy Secretary, U.S. Department of Health and
                                          Human Services.
                                       3. Date of nomination: January 18, 2021.
                                       4. Address (list current residence, office, and mailing addresses):

                                       5. Date and place of birth: October 5, 1972, Star Lake, NY.
                                       6. Marital status (include maiden name of wife or husband’s name):

                                       7. Names and ages of children:

                                       8. Education (list all secondary and higher education institutions, dates attended,
                                          degree received, and date degree granted):
                                          Washington University.
                                          Dates Attended: August 1994–May 1996.
                                          Degree Received: Master of Social Work.
                                          Date Degree Granted: May 1996.
                                          Cornell University.
                                          Dates Attended: August 1990–May 1994.
                                          Degree Received: Bachelor of Science.
                                          Date Degree Granted: May 1994.
                                          Clifton-Fine Central.
                                          Dates Attended: 7th–12th grade, September 1985–June 1990.
                                          Degree Received: High School Diploma.
                                          Date Degree Granted: June 1990.
                                       9. Employment record (list all jobs held since college, including the title or descrip-
                                          tion of job, name of employer, location of work, and dates of employment for
                                          each job):
                                          Wisconsin Department of Health Services.
                                          Secretary-designee.
                                          January 2019–January 2021.
                                          Madison, WI.
                                          U.S. Department of Health and Human Services.
                                          Senior Counselor to the Secretary (January 2015–January 2017).
                                          Chief of Staff (April 2013–December 2014).
                                          Counselor to the Secretary for Public Health (October 2011–April 2013).
                                          Senior Advisor to the White House Domestic Policy Council (detailed from HHS;
                                          August 2010–October 2011).
                                          Acting Assistant Secretary for Legislation (August 2009–July 2010).
                                          Deputy Assistant Secretary for Public Health Legislation (January 2009–July
                                          2009).




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                                                                                      106
                                          Washington, DC.
                                          Office of Senator Hillary Clinton.
                                          Senior Health Policy Advisor (January 2008–Janaury 2009).
                                          Legislative Assistant (June 2004–January 2008).
                                          Washington, DC.
                                          Office of Congressman Robert T. Matsui.
                                          Legislative Director (December 2003–May 2004).
                                          Senior Legislative Assistant (June 2001–December 2003).
                                          Washington, DC.
                                          Volunteers of America.
                                          Government Relations Manager (June 2000–May 2001).
                                          Public Policy Associate (October 1998–June 2000).
                                          Alexandria, VA.
                                          City of Phoenix.
                                          Policy Analyst, Human Services Department.
                                          June 1997–September 1998.
                                          Phoenix, AZ.
                                          Arizona Justice Institute.
                                          Equal Justice Fellow (Policy Analyst).
                                          October 1996–May 1997.
                                          Phoenix, AZ.
                                          ComCare.
                                          Crisis Counselor.
                                          January 1996–September 1996.
                                          Phoenix, AZ.
                                          Life Crisis Services.
                                          Development Director (part-time).
                                          August 1995–December 1995.
                                          St. Louis, MO.
                                          St. Louis Circuit Attorney’s Office.
                                          Victim Services Caseworker (part-time).
                                          January 1995–December 1995.
                                          St. Louis, MO.
                                          Children’s Home and Aid Society.
                                          Crisis Counselor.
                                          September 1994–December 1994.
                                          Mobile position; territory included the northern St. Louis, MO suburbs.
                                      10. Government experience (list any current and former advisory, consultative, hon-
                                          orary, or other part-time service or positions with Federal, State, or local gov-
                                          ernments held since college, including dates, other than those listed above):
                                          None.
                                      11. Business relationships (list all current and former positions held as an officer,
                                          director, trustee, partner (e.g., limited partner, non-voting, etc.), proprietor,
                                          agent, representative, or consultant of any corporation, company, firm, partner-
                                          ship, other business enterprise, or educational or other institution):
                                          None.
                                      12. Memberships (list all current and former memberships, as well as any current
                                          and former offices held in professional, fraternal, scholarly, civic, business, char-
                                          itable, and other organizations dating back to college, including dates for these
                                          memberships and offices):
                                          Arizona Arts Chorale.
                                          President (1997–1998).
                                          Member (1996–1998).
                                          Chi Omega Sorority.
                                          Alumna (1994–present).
                                          President (1993–1994).
                                          Rush Chair (1992–1993).
                                          House Manager (1991–1992).
                                      13. Political affiliations and activities:




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                                                                                      107
                                           a. List all public offices for which you have been a candidate dating back to the
                                              age of 18.
                                              None.
                                           b. List all memberships and offices held in and services rendered to all political
                                              parties or election committees, currently and during the last 10 years prior
                                              to the date of your nomination.
                                              None.
                                           c. Itemize all political contributions to any individual, campaign organization,
                                              political party, political action committee, or similar entity of $50 or more for
                                              the past 10 years prior to the date of your nomination.
                                              See Table.

                                                         Contribution Description                              Date             Amount

                                      HILLARY FOR AMERICA                                                         2016–07–24    $1,500.00

                                      HILLARY FOR AMERICA                                                         2016–08–31      $50.00

                                      HILLARY FOR AMERICA                                                         2016–09–21      $50.00

                                      HILLARY FOR AMERICA                                                         2016–09–26      $50.00

                                      HILLARY FOR AMERICA                                                         2016–10–19     $100.00

                                      HILLARY FOR AMERICA                                                         2016–10–27      $50.00

                                      HILLARY FOR AMERICA                                                         2016–10–29      $50.00

                                      HILLARY FOR AMERICA                                                         2016–10–31      $50.00

                                      HILLARY FOR AMERICA                                                         2016–11–01      $50.00

                                      HILLARY FOR AMERICA                                                         2016–11–03      $50.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2018–05–07     $250.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2018–09–22     $100.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2018–09–22     $100.00

                                      HALEY STEVENS FOR CONGRESS                                                  2018–09–22     $250.00

                                      SINEMA FOR ARIZONA                                                          2018–09–22     $100.00

                                      BREDESEN FOR SENATE                                                         2018–09–22     $100.00

                                      BETO FOR TEXAS                                                              2018–09–22     $100.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2018–09–29      $50.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2018–09–29      $50.00

                                      ROSEN FOR NEVADA                                                            2018–09–30     $100.00

                                      SINEMA FOR ARIZONA                                                          2018–09–30     $100.00

                                      HALEY STEVENS FOR CONGRESS                                                  2018–09–30     $100.00

                                      HALEY STEVENS FOR CONGRESS                                                  2018–09–30     $100.00

                                      HEIDI FOR SENATE                                                            2018–09–30     $250.00

                                      BREDESEN FOR SENATE                                                         2018–09–30     $100.00

                                      DONNELLY FOR INDIANA                                                        2018–09–30     $250.00




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                                                                                      108
                                                         Contribution Description                              Date             Amount

                                      HEIDI FOR SENATE                                                            2018–10–04    $250.00

                                      ROSEN FOR NEVADA                                                            2018–10–05    $100.00

                                      ROSEN FOR NEVADA                                                            2018–10–05    $100.00

                                      ROSEN FOR NEVADA                                                            2018–10–08    $100.00

                                      ROSEN FOR NEVADA                                                            2018–10–08    $100.00

                                      HEIDI FOR SENATE                                                            2018–10–08    $100.00

                                      HEIDI FOR SENATE                                                            2018–10–08    $100.00

                                      ROSEN FOR NEVADA                                                            2018–10–17    $100.00

                                      ROSEN FOR NEVADA                                                            2018–10–17    $100.00

                                      DONNELLY FOR INDIANA                                                        2018–10–18    $150.00

                                      DONNELLY FOR INDIANA                                                        2018–10–18    $150.00

                                      BREDESEN FOR SENATE                                                         2018–10–18    $100.00

                                      BREDESEN VICTORY FUND                                                       2018–10–18    $100.00

                                      HALEY STEVENS FOR CONGRESS                                                  2018–10–27     $50.00

                                      HALEY STEVENS FOR CONGRESS                                                  2018–10–27     $50.00

                                      DONNELLY FOR INDIANA                                                        2018–10–27    $100.00

                                      DONNELLY FOR INDIANA                                                        2018–10–27    $100.00

                                      BREDESEN FOR SENATE                                                         2018–10–27    $100.00

                                      BREDESEN FOR SENATE                                                         2018–10–27    $100.00

                                      ROSEN FOR NEVADA                                                            2018–10–27    $100.00

                                      ROSEN FOR NEVADA                                                            2018–10–27    $100.00

                                      SINEMA FOR ARIZONA                                                          2018–10–27    $100.00

                                      HEIDI FOR SENATE                                                            2018–10–27    $100.00

                                      STACEY ABRAMS                                                               2018–10–27    $250.00

                                      ANDREW GILLUM                                                               2018–10–27    $250.00

                                      RICHARD CORDRAY                                                             2018–10–27    $250.00

                                      LAURA KELLY                                                                 2018–10–27    $250.00

                                      TONY EVERS                                                                  2018–10–27    $250.00

                                      STEVE SISOLAK                                                               2018–10–27    $250.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2018–10–27    $100.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2018–10–27    $100.00

                                      SINEMA FOR ARIZONA                                                          2018–10–28    $100.00

                                      HEIDI FOR SENATE                                                            2018–10–28    $100.00




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                                                         Contribution Description                              Date             Amount

                                      PHIL HERNANDEZ                                                              2019–06–09    $250.00

                                      JOSH KAUL                                                                   2019–06–12    $250.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2019–06–25    $250.00

                                      HALEY STEVENS FOR CONGRESS                                                  2019–06–25    $250.00

                                      TONY EVERS                                                                  2019–06–29    $250.00

                                      HALEY STEVENS FOR CONGRESS                                                  2019–09–11    $100.00

                                      HALEY STEVENS FOR CONGRESS                                                  2019–09–11    $100.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2020–01–14    $100.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2020–01–14    $100.00

                                      HALEY STEVENS FOR CONGRESS                                                  2020–06–07    $100.00

                                      HALEY STEVENS FOR CONGRESS                                                  2020–06–07    $100.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2020–06–07    $100.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2020–06–07    $100.00

                                      MCGRATH FOR U.S. SENATE                                                     2020–06–07    $125.00

                                      DITCH FUND                                                                  2020–06–07    $125.00

                                      MARK KELLY FOR SENATE                                                       2020–06–07    $100.00

                                      THERESA GREENFIELD FOR IOWA                                                 2020–06–07    $100.00

                                      DOUG JONES FOR U.S. SENATE                                                  2020–06–07    $100.00

                                      HICKENLOOPER FOR COLORADO                                                   2020–06–07    $100.00

                                      CAL FOR NC                                                                  2020–06–07    $100.00

                                      SARA GIDEON FOR MAINE                                                       2020–06–07    $250.00

                                      JAIME HARRISON FOR U.S. SENATE                                              2020–06–07    $250.00

                                      MONTANANS FOR BULLOCK                                                       2020–06–07    $250.00

                                      BIDEN FOR PRESIDENT                                                         2020–06–07    $250.00

                                      BIDEN FOR PRESIDENT                                                         2020–08–27    $250.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2020–08–27    $100.00

                                      HALEY STEVENS FOR CONGRESS                                                  2020–08–27    $100.00

                                      MONTANANS FOR BULLOCK                                                       2020–08–27    $250.00

                                      JAIME HARRISON FOR U.S. SENATE                                              2020–08–27    $250.00

                                      SARA GIDEON FOR MAINE                                                       2020–08–27    $250.00

                                      CAL FOR NC                                                                  2020–08–27    $250.00

                                      DOUG JONES FOR U.S. SENATE                                                  2020–08–27    $100.00

                                      THERESA GREENFIELD FOR IOWA                                                 2020–08–27    $250.00




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                                                                                      110
                                                         Contribution Description                              Date               Amount

                                      MARK KELLY FOR SENATE                                                       2020–08–27       $100.00

                                      LAUREN UNDERWOOD FOR CONGRESS                                               2020–08–27       $100.00

                                      HALEY STEVENS FOR CONGRESS                                                  2020–08–27       $100.00

                                      AMY MCGRATH FOR SENATE, INC.                                                2020–08–27       $250.00

                                      HICKENLOOPER FOR COLORADO                                                   2020–08–27       $250.00

                                      JON OSSOFF FOR SENATE                                                       2020–08–27       $250.00

                                      JON OSSOFF FOR SENATE                                                       2020–12–06       $250.00

                                      WARNOCK FOR GEORGIA                                                         2020–12–06       $250.00

                                      14. Honors and awards (list all scholarships, fellowships, honorary degrees, hon-
                                          orary society memberships, military medals, and any other special recognitions
                                          for outstanding service or achievement received since the age of 18):
                                          Brown School of Social Work Distinguished Alumni Award, Washington Univer-
                                          sity: 2016.
                                      15. Published writings (list the titles, publishers, dates, and hyperlinks (as applica-
                                          ble) of all books, articles, reports, blog posts, or other published materials you
                                          have written):
                                          None.
                                      16. Speeches (list all formal speeches and presentations (e.g., PowerPoint) you have
                                          delivered during the past 5 years which are on topics relevant to the position
                                          for which you have been nominated, including dates):
                                          Below is a list that covers my tenure as the Wisconsin Department of Health
                                          Services Secretary-designee. In the 3 years prior to that, I did not deliver any
                                          speeches relevant to the position for which I have been nominated.

                                                                       Speech Forum                                              Date

                                      CCS Spring Conference                                                                     2019–04–16

                                      Wisconsin Assisted Living Association Conference                                          2019–04–30

                                      Doctor Day Conference                                                                     2019–05–01

                                      Wisconsin Public Health Association Conference                                            2019–05–23

                                      Surgical Collaborative of Wisconsin                                                       2019–05–29

                                      Bx Health Budget                                                                          2019–06–06

                                      SUD Prevention Conference                                                                 2019–06–11

                                      Drug Endangered Children Conference                                                       2019–07–16

                                      Wisconsin Personal Services Association Conference                                        2019–09–18

                                      Caregivers Taskforce Launch                                                               2019–09–25

                                      Disability Service Provider Network Conference                                            2019–10–17

                                      Covering Wisconsin 211 Webinar                                                            2019–10–21

                                      DHS DQA FOCUS Conference                                                                  2019–11–21

                                      LeadingAge Conference                                                                     2020–02–18

                                      WAFCA Leadership Summit                                                                   2020–03–05




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                                                                       Speech Forum                                              Date

                                      Rep. Gallagher Teletownhall                                                               2020–03–26

                                      Rep. Kind Teletownhall                                                                    2020–03–26

                                      Rep. Kind Teletownhall                                                                    2020–06–04

                                      Wisconsin Assisted Living Annual Conference                                               2020–09–17

                                      17. Qualifications (state what, in your opinion, qualifies you to serve in the position
                                          to which you have been nominated):
                                          I believe my public health and social services expertise and extensive health
                                          care and management experience qualify me to serve as the Deputy Secretary
                                          of the U.S. Department of Health and Human Services (HHS).
                                          I have been in public service for the vast majority of my career, from my ear-
                                          liest days as a caseworker for crime victims to my time as a crisis counselor
                                          for individuals struggling with serious mental health conditions and contem-
                                          plating suicide. I have broad experience in health care, behavioral health, public
                                          health, and children and families issues—working for private, non-profit organi-
                                          zations, as well as local, State, and Federal Government in direct service,
                                          policy-making, and administrative roles.
                                          During my tenure at HHS during the Obama-Biden administration, I worked
                                          on the legislative formulation and implementation of major bipartisan efforts,
                                          including the Food Safety Modernization Act, the Tobacco Control Act, reau-
                                          thorization of the Ryan White Act, and the 21st Century Cures Act, among oth-
                                          ers. As a member of the HHS Budget Council, I helped craft and implement
                                          each budget enacted during the Obama-Biden administration.
                                          As the Chief of Staff at HHS, I oversaw the operations of the Secretary’s office,
                                          which includes a number of offices that provide support to the work of the De-
                                          partment and the Department’s external partners, including communications,
                                          legislative and external affairs, as well as the general counsel, budget, and ad-
                                          ministrative functions, among others. In my final role at HHS, I served as the
                                          lead for the Department’s agency-wide work to stem the tide of the opioid epi-
                                          demic and enact then-Vice President Biden’s Cancer Moonshot Initiative.
                                          As the Department of Health Services (DHS) Secretary-designee, I ran one of
                                          the largest State agencies in Wisconsin, with an annual budget of $12 billion
                                          and more than 6,100 employees. I was responsible for the State Medicaid pro-
                                          gram, the Supplemental Nutrition Assistance Program (SNAP), and behavioral
                                          health programs, among others. I was also responsible for the health and safety
                                          of Wisconsinites living at our seven 24/7 residential facilities. And as the public
                                          health agency for the State of Wisconsin, I led the State’s response to the
                                          COVID–19 pandemic.
                                          During my tenure as Secretary-designee, I worked with the Legislature to enact
                                          a bipartisan telehealth bill, which was fundamental to our ability to expand ac-
                                          cess to care across the State, particularly in Wisconsin’s many rural commu-
                                          nities. It was also a critical springboard for the State’s ability to maintain and
                                          further expand access to care during the pandemic, particularly for behavioral
                                          health care.
                                          I was also proud to secure bipartisan support for State funding to allow the
                                          draw-down of additional Children’s Health Insurance Program dollars to sup-
                                          port a Lead Safe Homes Initiative. Wisconsin is one of just a handful of States
                                          to take this innovative approach to address a critical public health issue for
                                          children and families.
                                          As Secretary-designee, I launched the first-ever employee engagement effort at
                                          DHS, including an annual employee viewpoint survey to gauge the strengths of
                                          the organization and identify areas for improvement in an effort to attract and
                                          retain the best public servants at DHS.
                                          As we tackle the COVID–19 pandemic and help the American people recover,
                                          the work of the U.S. Department of Health and Human Services has never been
                                          more important than it is right now. I believe my experiences and background
                                          qualify me for the role of Deputy Secretary, and I am honored by President
                                          Biden’s nomination and ready for this responsibility. I would sincerely look for-




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                                           ward to the opportunity to work with the members of this committee, should
                                           I be confirmed.

                                                          B. FUTURE EMPLOYMENT RELATIONSHIPS
                                       1. Will you sever all connections (including participation in future benefit arrange-
                                          ments) with your present employers, business firms, associations, or organiza-
                                          tions if you are confirmed by the Senate? If not, provide details.
                                           Yes.
                                       2. Do you have any plans, commitments, or agreements to pursue outside employ-
                                          ment, with or without compensation, during your service with the government?
                                          If so, provide details.
                                           No.
                                       3. Has any person or entity made a commitment or agreement to employ your
                                          services in any capacity after you leave government service? If so, provide de-
                                          tails.
                                           No.
                                       4. If you are confirmed by the Senate, do you expect to serve out your full term
                                          or until the next presidential election, whichever is applicable? If not, explain.
                                           Yes.

                                                            C. POTENTIAL CONFLICTS OF INTEREST
                                       1. Indicate any current and former investments, obligations, liabilities, or other
                                          personal relationships, including spousal or family employment, which could in-
                                          volve potential conflicts of interest in the position to which you have been nomi-
                                          nated.
                                          Any potential conflict of interest will be resolved in accordance with the terms
                                          of my ethics agreement, which was developed in consultation with ethics offi-
                                          cials at the Department of Health and Human Services and the Office of Gov-
                                          ernment Ethics. I understand that my ethics agreement has been provided to
                                          the committee. I am not aware of any potential conflict other than those ad-
                                          dressed by my ethics agreement.
                                       2. Describe any business relationship, dealing, or financial transaction which you
                                          have had during the last 10 years (prior to the date of your nomination), wheth-
                                          er for yourself, on behalf of a client, or acting as an agent, that could in any
                                          way constitute or result in a possible conflict of interest in the position to which
                                          you have been nominated.
                                          Any potential conflict of interest will be resolved in accordance with the terms
                                          of my ethics agreement, which was developed in consultation with ethics offi-
                                          cials at the Department of Health and Human Services and the Office of Gov-
                                          ernment Ethics. I understand that my ethics agreement has been provided to
                                          the committee. I am not aware of any potential conflict other than those ad-
                                          dressed by my ethics agreement.
                                       3. Describe any activity during the past 10 years (prior to the date of your nomina-
                                          tion) in which you have engaged for the purpose of directly or indirectly influ-
                                          encing the passage, defeat, or modification of any legislation or affecting the ad-
                                          ministration and execution of law or public policy. Activities performed as an
                                          employee of the Federal Government need not be listed.
                                          In the last 2 years as Wisconsin Department of Health Services Secretary-
                                          designee, I have been involved in a number of legislative and public policy
                                          issues at the local and State level on behalf of my Department and the Evers
                                          administration. Also in this role, I have been involved in advocating at the Fed-
                                          eral level on health policies of concern to the State of Wisconsin. Prior to that,
                                          I had no activity or was an employee of the Federal government.
                                       4. Explain how you will resolve any potential conflict of interest, including any
                                          that are disclosed by your responses to the above items.
                                          Any potential conflict of interest will be resolved in accordance with the terms
                                          of my ethics agreement, which was developed in consultation with ethics offi-
                                          cials at the Department of Health and Human Services and the Office of Gov-
                                          ernment Ethics. I understand that my ethics agreement has been provided to




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                                                                                      113
                                          the committee. I am not aware of any potential conflict other than those ad-
                                          dressed by my ethics agreement.
                                       5. Two copies of written opinions should be provided directly to the committee by
                                          the designated agency ethics officer of the agency to which you have been nomi-
                                          nated and by the Office of Government Ethics concerning potential conflicts of
                                          interest or any legal impediments to your serving in this position.
                                          I understand that my ethics agreement has been provided to the committee.

                                                                   D. LEGAL AND OTHER MATTERS
                                       1. Have you ever been the subject of a complaint or been investigated, disciplined,
                                          or otherwise cited for a breach of ethics for unprofessional conduct before any
                                          court, administrative agency (e.g., an Inspector General’s office), professional as-
                                          sociation, disciplinary committee, or other ethics enforcement entity at any
                                          time? Have you ever been interviewed regarding your own conduct as part of
                                          any such inquiry or investigation? If so, provide details, regardless of the out-
                                          come.
                                          No.
                                       2. Have you ever been investigated, arrested, charged, or held by any Federal,
                                          State, or other law enforcement authority for a violation of any Federal, State,
                                          county, or municipal law, regulation, or ordinance, other than a minor traffic
                                          offense? Have you ever been interviewed regarding your own conduct as part
                                          of any such inquiry or investigation? If so, provide details.
                                          No.
                                       3. Have you ever been involved as a party in interest in any administrative agency
                                          proceeding or civil litigation? If so, provide details.
                                          I have not been involved in any administrative proceedings or civil litigation in
                                          my personal capacity. Supplemental information: In my official capacity as
                                          former Wisconsin Department of Health Services Secretary-designee, I was
                                          sometimes named in litigation.
                                       4. Have you ever been convicted (including pleas of guilty or nolo contendere) of
                                          any criminal violation other than a minor traffic offense? If so, provide details.
                                          No.
                                       5. Please advise the committee of any additional information, favorable or unfavor-
                                          able, which you feel should be considered in connection with your nomination.
                                          N/A.

                                                               E. TESTIFYING BEFORE CONGRESS
                                       1. If you are confirmed by the Senate, are you willing to appear and testify before
                                          any duly constituted committee of the Congress on such occasions as you may
                                          be reasonably requested to do so?
                                          Yes.
                                       2. If you are confirmed by the Senate, are you willing to provide such information
                                          as is requested by such committees?
                                          Yes.

                                                                                   ----

                                                   QUESTIONS SUBMITTED FOR THE RECORD TO ANDREA JOAN PALM

                                                              QUESTION SUBMITTED BY HON. RON WYDEN
                                                RACIAL AND ETHNIC DISPARITIES WITHIN THE CHILD WELFARE SYSTEM

                                        Question. The child welfare system is rife with racial, ethnic, and socioeconomic
                                      disparities. Black and American Indian children are over-represented in the child
                                      welfare system, and there are clear disparities that children and families of color
                                      experience when interacting with the child welfare system. As you know, the Family
                                      First Prevention Services Act (FFPSA) is groundbreaking in its support and financ-
                                      ing of evidence-based prevention services for children and parents to help them stay
                                      safely together and thrive.




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                                        If confirmed, how will you ensure that FFPSA implementation lives up to its con-
                                      gressional intent?
                                        In particular, how will you ensure the prevention services allowable under FFPSA
                                      are as inclusive and expansive as possible to ensure that there are a range of serv-
                                      ices for States and tribes to utilize that are culturally sensitive and have dem-
                                      onstrated positive outcomes for underserved communities, including tribal nations,
                                      black, Latinx, LGBTQ+ communities, and older, aging-out foster youth?
                                        Answer. The Family First Prevention Services Act (FFPSA) is an important law
                                      that seeks to transform child welfare services by increasing support for evidence-
                                      based prevention services to strengthen families and keep children and youth safely
                                      at home and in their communities with their parents, other family members or kin
                                      whenever possible. If confirmed as Deputy Secretary, I will be committed to ensur-
                                      ing that the prevention services available are culturally appropriate and responsive
                                      to the needs of all people and communities, especially communities that have been
                                      traditionally underserved. As you know, the Biden administration and Secretary
                                      Becerra are committed to advancing racial equity and support for underserved com-
                                      munities, as reflected in the executive order the President signed on his first day
                                      in office, ‘‘Advancing Racial Equity and Support for Underserved Communities
                                      Through the Federal Government.’’ As Deputy Secretary, I will strive to advance
                                      this goal in all of our work.

                                                                                   ----
                                                           QUESTIONS SUBMITTED BY HON. SHERROD BROWN
                                                                           PROVIDER RELIEF FUND

                                         Question. Throughout the past year, Congress has dedicated significant resources
                                      toward supporting hospitals and other health-care providers who have been nega-
                                      tively impacted by COVID–19. One of the largest sources of funding for provider re-
                                      lief has been through the Provider Relief Fund.
                                         If confirmed, will you commit to ensuring future distributions from the provider
                                      relief fund are equitable and transparent, and prioritize funding for those providers
                                      and facilities that continue to disproportionately struggle because of the pandemic?
                                         Answer. During the pandemic, while some providers have experienced challenges
                                      with overcapacity, many other providers have faced financial setbacks related to
                                      billing disruption, the suspension of non-essential surgeries and procedures, and
                                      health-care staff unable to work. HHS is committed to supporting providers who are
                                      taking care of patients during this pandemic and to making payments quickly while
                                      ensuring program integrity and effective oversight. If confirmed, I will work to en-
                                      sure that the Provider Relief Fund is run transparently and equitably.
                                                                        FDA CONSUMER PROTECTION

                                         Question. The Food and Drug Administration (FDA) is first and foremost a con-
                                      sumer protection agency; however, in the past there have been times when the FDA
                                      has served as little more than a rubber stamp for industry. It is time to rebuild con-
                                      sumer confidence in the FDA and give the FDA the tools, resources, and authorities
                                      it needs to help protect our health and safety.
                                         We have to be more aggressive on youth vaping and nicotine reduction. We must
                                      examine our drug supply chain and assess and correct vulnerabilities and gaps.
                                         If confirmed, how will you work with Secretary Becerra and the FDA Commis-
                                      sioner to ensure the consumer, the patient, remains at the center of all of the work
                                      HHS does—including the FDA?
                                         Answer. Patients and families should be at the heart of all of the work of HHS.
                                      It will be necessary for many agencies within HHS to work together in order to ad-
                                      dress this important issue. The work of FDA is critical for assuring consumer pro-
                                      tections, including through tobacco regulation and ensuring the safety and security
                                      of our drug supply chain. If confirmed, I look forward to working on these issues.
                                                                                 BIOSIMILARS

                                         Question. Thank you for your commitment to lowering the high cost of prescrip-
                                      tion drugs. The robust uptake of biosimilars represents an opportunity to increase
                                      competition in the prescription drug marketplace and reduce costs for patients and
                                      taxpayers. I’d like to work with you on ways to maximize the uptake of biosimilars




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                                      as they enter the market to ensure competition and reduce patient out-of-pocket
                                      cost.
                                        If confirmed, what additional steps should and will you take to build out a robust
                                      biosimilars market and ensure all patients who require treatment have immediate
                                      access to high quality, affordable biosimilar biologic medicines?
                                        Answer. Like President Biden and Secretary Becerra, I believe we must do all we
                                      can to lower the costs of prescription drugs and make them more accessible for
                                      Americans who depend on them. Competition in the market has helped control the
                                      growth in spending on prescription drugs. I believe that biosimilars have a role to
                                      play in containing the cost of expensive therapies by creating competition. I am com-
                                      mitted to reducing drug prices and ensuring Americans have access to the drugs
                                      that they need. If confirmed, I look forward to working with you to find ways to
                                      achieve these important goals. I will also work across the government to address
                                      barriers to reducing drug prices.
                                                                           ANTIBIOTIC RESISTANCE

                                        Question. From the CDC to the World Health Organization, public health experts
                                      consider antibiotic resistance to be one of the top threats to global health security.
                                      The threat posed by superbugs demands swift action and a robust response.
                                        I urge you to commit to building on the National Action Plan for Combating
                                      Antibiotic-Resistant Bacteria (CARB) and follow through on coordinated, strategic
                                      actions to address antibiotic resistance.
                                         What actions will you take, amidst and after this pandemic, to prioritize our Na-
                                      tion’s fight against antibiotic resistance in addition to building out our antibiotic
                                      stewardship programs and curbing the overuse of antibiotics?
                                        Answer. It is clear that antimicrobial resistance (AMR) must be a top public
                                      health priority, not only for the United States but around the world. Even during
                                      this time, AMR remains a top HHS priority, and if confirmed, we will continue in-
                                      vesting in key prevention strategies like early detection and containment, infection
                                      prevention, and ensuring the appropriate use of antibiotics in the U.S. and around
                                      the world. If confirmed, I will also support efforts to develop new antibiotics to treat
                                      infections that are becoming untreatable.

                                                                                    ----
                                                          QUESTIONS SUBMITTED BY HON. ELIZABETH WARREN
                                                                      OVER-THE-COUNTER HEARING AIDS

                                         Question. In 2017, President Trump signed into law the Over-the-Counter Hear-
                                      ing Aid Act, a bill that I introduced with Senator Grassley, Senator Hassan, and
                                      Senator Isakson. The bill requires the FDA to categorize certain hearing aids as
                                      over the counter (OTC). Under law, the FDA was required to issue regulations re-
                                      garding OTC hearing aid safety and manufacturing by August 18, 2020—but the
                                      agency failed to issue the rules on time. As Deputy Secretary of Health and Human
                                      Services, will you commit to (1) identifying the reason(s) why the OTC hearing aid
                                      proposed rules have been delayed past their statutory deadline, (2) identifying the
                                      individual(s) responsible for developing and releasing the proposed rules, (3) requir-
                                      ing those individual(s) to release the proposed rules as soon as possible, and (4) re-
                                      quiring those individual(s) to communicate frequently with my office on the timeline
                                      for the rules’ release?
                                         Answer. Thank you for your leadership on this issue. I commit that, if confirmed,
                                      I will support FDA in its rulemaking regarding over-the-counter hearing aids and
                                      look forward to working closely with you on this issue. I recognize this is a public
                                      health priority as hearing loss can have a negative effect on communication, rela-
                                      tionships, and other important aspects of life.
                                                                   THIRD-PARTY MEDICAL DEVICE SERVICING

                                        Question. The Food and Drug Administration is responsible for ensuring the safe-
                                      ty of medical devices. While some medical devices are disposable and are used only
                                      once, others are used repeatedly on multiple patients. Original equipment manufac-
                                      turers and third-party entities often refurbish, repair, recondition, rebuild, re-
                                      market, or remanufacture these devices to ensure that they continue to operate safe-
                                      ly and effectively after entering the market.




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                                         Entities that perform maintenance activities are subject to different regulatory re-
                                      quirements depending on the type of maintenance being performed. Activities that
                                      ‘‘significantly change’’ the performance, safety specifications, or intended use of a de-
                                      vice are considered ‘‘remanufacturing’’ activities, while activities that do not change
                                      the device are considered ‘‘servicing.’’ FDA has committed to issuing guidance clari-
                                      fying the difference between ‘‘remanufacturing’’ and ‘‘servicing.’’ In a 2020 letter to
                                      me and Senator Cassidy, FDA stated that it ‘‘intends to clarify the definitions of
                                      these activities so that entities can determine in which activities they are engaged,
                                      and with which regulatory requirements they should comply.’’ The agency said it
                                      would issue the guidance during FY2020, but it has not yet done so. As Deputy Sec-
                                      retary of Health and Human Services, will you commit to (1) identifying the rea-
                                      son(s) why this guidance has been delayed, (2) identifying the individual(s) respon-
                                      sible for developing and releasing that guidance, and (3) requiring those indi-
                                      vidual(s) to communicate frequently with my office on the timeline for the guid-
                                      ance’s release?
                                         Answer. Ensuring the appropriate consumer protections to keep patients and fam-
                                      ilies safe is a top priority for the Biden-Harris administration. If confirmed, I com-
                                      mit to supporting FDA in their work issuing guidance related to third party medical
                                      device servicing. I recognize that this is a complicated issue and regulatory clarity
                                      is very important.

                                                                                    ----
                                                              QUESTIONS SUBMITTED BY HON. MIKE CRAPO
                                                                       PRIVATE INSURANCE MARKETS

                                        Question. How do you view HHS’s role in the individual market, and what re-
                                      forms would you propose that could affect the types of plans offered to consumers?
                                         Answer. The Affordable Care Act expanded critical consumer protections to mil-
                                      lions of consumers enrolled in individual market plans across the country. HHS
                                      works together with States to make sure that consumers receive these important
                                      benefits. If confirmed, it will be a priority of mine to build on the successes of the
                                      ACA and to work with the Centers for Medicare and Medicaid Services to make sure
                                      American patients and their families continue to have access to quality, affordable
                                      health care.
                                                                               MEDICAID WAIVERS

                                        Question. What is your view of the appropriate role of incentives and disincentives
                                      in the Federal Government’s partnership with State agencies?
                                         Answer. The partnership between States and the Federal Government is central
                                      to Medicaid. I know each State—including Idaho—is unique, and innovation is crit-
                                      ical to improving the health-care system. If confirmed, I will support State innova-
                                      tion and the ability of States to test different models that meet the objectives of the
                                      Medicaid program. I look forward to working with colleagues at the Centers for
                                      Medicare and Medicaid Services on this issue and to hearing morefrom you about
                                      what ideas are working in Idaho.
                                                                               MEDICARE SOLVENCY

                                         Question. Medicare is on a near-term path toward bankruptcy. The HI trust fund
                                      could be insolvent in anywhere from 4 to 5 years. Other than during the first few
                                      years of the Medicare program’s existence, Congress has never allowed the HI trust
                                      fund to project less than 4 years of solvency without acting in order to minimize
                                      the impact on health-care providers, taxpayers, and beneficiaries. Given the looming
                                      fiscal crisis, how soon can we expect a comprehensive legislative proposal from HHS
                                      that extends the life of the HI trust fund?
                                        Answer. Medicare solvency is an incredibly important, longstanding issue. I look
                                      forward to working with Congress, and in concert with the Centers for Medicare and
                                      Medicaid Services, on a bipartisan basis to address this. We will need both short-
                                      term and long-term strategies to make sure Medicare remains a bedrock of our
                                      health-care system. It is essential that we protect and strengthen this program for
                                      Americans who have spent their lives paying into it.




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                                                           QUESTIONS SUBMITTED BY HON. CHUCK GRASSLEY
                                         Question. The Family First Prevention Services Act allows States to receive Fed-
                                      eral reimbursement for prevention services in order to keep children with their fam-
                                      ilies whenever possible. In order to qualify for IV–E reimbursement, programs are
                                      required to be evidence-based. Currently, there are 29 programs that have been
                                      rated as promising, supported, or well-supported, and many programs are still
                                      awaiting evaluation on the Administration for Children and Families’ (ACF) Clear-
                                      inghouse. The COVID–19 pandemic has caused prevention service providers to alter
                                      their service models to comply with social distancing and other precautions. Addi-
                                      tionally, some programs have faced decreased capacity or enrollment, leading to
                                      challenges in maintaining population sizes necessary for an evaluation. If confirmed,
                                      how will you work to ensure that ACF continues to add programs to the clearing-
                                      house while maintaining the standards for evidence-based practices required by the
                                      Family First Prevention Services Act?
                                         Answer. The Family First Prevention Services Act (FFPSA) is a law that offers
                                      the promise to transform child welfare services by increasing the availability of
                                      evidence-based prevention services to strengthen families and keep children and
                                      youth safely at home and in their communities with their parents, or kin whenever
                                      possible. If confirmed as Deputy Secretary, I will work with the leadership of ACF
                                      to ensure that the Title IV–E Prevention Services Clearinghouse has adequate re-
                                      sources to be able to review and rate programs in a timely manner. I will also sup-
                                      port the continued development of evidence-based practices through support of qual-
                                      ity evaluation.
                                         Question. Many States, including my home State of Iowa, have faced a shortage
                                      of qualified foster parents in recent years. The COVID–19 pandemic has exacer-
                                      bated these shortages in many areas. In addition to getting new foster parents in-
                                      volved, there is a challenge in retaining foster parents for longer than 1 year. If con-
                                      firmed, how would you work to improve foster parent recruitment and retention so
                                      that children are not placed in inappropriate settings due to a lack of available fos-
                                      ter homes?
                                         Answer. I understand the important role that foster parents play in caring for
                                      children. As reflected in the policy goals of the Family First Prevention Services Act,
                                      when children must enter foster care, family foster homes—preferably kinship
                                      care—must be the preferred placement setting and institutional placements used
                                      only under limited circumstances. Whenever possible, child welfare systems must
                                      seek relatives and kin to care for children, to reduce the trauma children experience
                                      when they are separated from their parents. The COVID–19 pandemic has placed
                                      great strain on all parents, including foster parents and kinship caregivers, and has
                                      had an impact on the ability to train and engage prospective foster parents and sup-
                                      port existing foster parents. I think it is essential that child welfare agencies pro-
                                      vide adequate support to foster parents, including relative caregivers and that they
                                      be proactive in recruiting diverse families to meet the needs of children who must
                                      come into foster care. If confirmed, I will work with leaders of the Administration
                                      for Children and Families to provide support for foster parent recruitment and re-
                                      tention.
                                         Question. The Adoption and Safe Families Act of 1997 required States to ensure
                                      that children in foster care did not languish in the system without permanency. It
                                      established that parental rights should be terminated if children have been in foster
                                      care for 15 out of the last 22 months. The law allows for exceptions if it is deter-
                                      mined that there is a compelling reason that termination of parental rights is not
                                      in a child’s best interest, or other limited reasons. States are not required to collect
                                      data on the enforcement of this law, and often do not provide a reason for granting
                                      an exception. If confirmed, will you work to improve oversight of this law to ensure
                                      that States are acting in the best interest of children?
                                         Answer. When children must enter into care, it is essential that we seek to ensure
                                      timely permanency. Whenever possible we should seek to support safe and timely
                                      reunification of children with their parents or extended family, but this is not al-
                                      ways possible. As you note, the Adoption and Safe Families Act of 1997 established
                                      time frames for the filing of petitions to terminate parental rights, but allowed for
                                      certain exceptions. If confirmed, I will work with the Administration for Children
                                      and Families to review oversight of this provision and explore any additional steps
                                      that may be needed to promote the best interests of children.
                                         Question. In 2017, I sponsored the Over-the-Counter Hearing Aid Act with Sen-
                                      ator Warren, which was included in the FDA Reauthorization Act of 2017. It re-




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                                      quired the Food and Drug Administration (FDA) to issue a regulation by August
                                      2020 establishing the requirements for products in this category. This legislation
                                      was based on recommendations put forth by the Presidential Council of Advisors on
                                      Science and Technology and the National Academies of Science Engineering and
                                      Medicine to increase consumer access to hearing aid technology and decrease costs
                                      associated with hearing aids. The FDA has not completed rulemaking on this. If
                                      confirmed, will you work to prioritize rulemaking so consumers can access afford-
                                      able help for hearing loss that Congress intended?
                                         Answer. Thank you for your leadership on this issue. I commit that, if confirmed,
                                      I will support FDA in its rulemaking and work to ensure availability of over-the-
                                      counter hearing aids. I recognize this is a public health priority as hearing loss can
                                      have a negative effect on communication, relationships, and other important aspects
                                      of life.
                                         Question. I support transparency in the 340B Drug Pricing Program. The previous
                                      administration finalized a 340B Drug Pricing Program Administrative Dispute Reso-
                                      lution regulation that went into effect in January 2021. This final rule sets forth
                                      the requirements and procedures for the 340B Program’s administrative dispute res-
                                      olution (ADR) process. The rule establishes a 340B Administrative Dispute Resolu-
                                      tion Board to review claims. In addition, on December 30, 2020, the Department of
                                      Health and Human Services’ Office of the General Counsel released an advisory
                                      opinion. If confirmed, are you committed to the continued implementation of the
                                      340B Drug Pricing Program Administrative Dispute Resolution final rule and Office
                                      of General Counsel’s advisory opinion? If confirmed, what detailed steps will the
                                      Biden administration take to ensure transparency in the 340B Drug Pricing Pro-
                                      gram?
                                         Answer. The 340B Drug Pricing Program is an indispensable program for our
                                      safety-net providers serving some of our neediest populations. If confirmed, I look
                                      forward to working with you and other members of Congress to uphold the law and
                                      ensure this vital program is able to continue supporting vulnerable communities.
                                         Question. During the last 2 years as chairman of the Senate Finance Committee,
                                      I’ve focused some of my oversight on what steps the Department of Health and
                                      Human Services has taken to detect and deter foreign threats to taxpayer-funded
                                      research. As part of my oversight, I’ve also worked to ensure that the Department’s
                                      Office of National Security is given full, complete, and consistent access to all Intel-
                                      ligence Community information involving threats to the Nation’s health care, such
                                      as COVID–19. That office has gained access to some Intelligence Community ele-
                                      ments but more must be done. On March 8, 2021, I wrote a follow-up letter to the
                                      Department of Health and Human Services and the Director of National Intelligence
                                      asking what they’ve done to incorporate Federal health agencies into the Intel-
                                      ligence Community. HHS has failed to respond. If confirmed, will you commit to an-
                                      swering that letter in full? If confirmed, will you commit to updating me on the
                                      functions of the Office of National Security and how it’s interacting within the Intel-
                                      ligence Community?
                                         Answer. HHS is committed to working with Congress on its critical oversight
                                      work. As I noted in my hearing, if confirmed, I look forward to working with you
                                      on this issue.
                                         Question. In 2020, I cosponsored the Temporary Reauthorization and Study of the
                                      Emergency Scheduling of Fentanyl Analogues Act and it was signed into law. The
                                      law extended the Drug Enforcement Administration’s temporary scheduling order to
                                      proactively control deadly fentanyl analogues. Fentanyl-related overdose deaths con-
                                      tinue to rise and sophisticated drug trafficking organizations manipulate dangerous
                                      substances to skirt the law, so this critical law placed fentanyl substances in Sched-
                                      ule I so that they can be better detected and criminals can be held accountable for
                                      their actions. The law sunsets in May of 2021. In December 2019, 56 other State
                                      and territory Attorneys General asked Congress to permanently codify a temporary
                                      emergency scheduling order keeping fentanyl-related substances classified as Sched-
                                      ule I drugs. If confirmed, do you support permanently codifying a temporary emer-
                                      gency scheduling order keeping fentanyl-related substances classified as Schedule I
                                      drugs?
                                         Answer. If confirmed, I will work with you on legislation to ensure the appro-
                                      priate scheduling of fentanyl and fentanyl analogues that pose a danger.
                                         Question. Science tells us that an unborn child has many of the neural connec-
                                      tions needed to feel pain, perhaps as early as eight weeks and most certainly by
                                      20 weeks fetal age. Providing health care to unborn children and their mothers can




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                                      help reduce infant mortality rates in low-income communities, research also sug-
                                      gests. Some States already offer prenatal care and other health services to unborn
                                      children through the Medicaid program. What is your view on whether unborn chil-
                                      dren should be entitled to Medicaid coverage, and do you believe that the Federal
                                      Government has a role to play in encouraging such coverage?
                                        Answer. Medicaid is an important source of pre- and post-natal care, and if I am
                                      confirmed, I will work to ensure access to quality pregnancy care that improves
                                      their own health and the health of their babies. I was happy to see that Congress
                                      included incentives for States to expand Medicaid postpartum coverage in the Amer-
                                      ican Rescue Plan and that CMS has approved section 1115 demonstration projects
                                      to this effect. I look forward to working with members of this committee and Con-
                                      gress to expand access to affordable, quality care, including through the Medicaid
                                      program.
                                        Question. Congress’s ability to acquire information from Federal agencies is crit-
                                      ical to its constitutional responsibility of conducting oversight of the executive
                                      branch. If you are confirmed, will you commit to providing thorough, complete, and
                                      timely responses to requests for information from members of this committee, in-
                                      cluding requests from members of the Minority?
                                        Answer. If confirmed, I will provide responses to requests from any members of
                                      this committee.
                                        Question. In 2019, Congress passed bipartisan the Advancing Care for Exceptional
                                      (ACE) Kids Act to improve health outcomes and care coordination for children with
                                      complex medical conditions in Medicaid. In 2020, I introduced the bipartisan Accel-
                                      erating Kids’ Access to Care Act to further help families gain access to life-saving
                                      care for children with complex medical conditions. The legislation aims to facilitate
                                      access to care while retaining program safeguards and reducing regulatory burdens
                                      on providers. If confirmed, what steps would you take to improve the system of care
                                      for children with complex medical conditions?
                                        Answer. Thank you for your leadership on the ACE Kids Act and your focus on
                                      access to care for children with complex medical needs. I agree that we should do
                                      all we can to remove barriers to care for these children. If I am fortunate enough
                                      to be confirmed, I will look forward to working with you on solutions to ensure chil-
                                      dren with complex medical needs get the best care possible.
                                        Question. In Iowa, transitional health plans (including grandmothered health
                                      plans) have enabled many middle-class Iowans to keep the health plans and doctors
                                      they like at a reasonable price since the Affordable Care Act was implemented. For
                                      example, over 56,000 Iowans are covered by grandmothered health plans. To put
                                      this in context, about 60,000 Iowans signed up for the Federal health insurance ex-
                                      change in 2021. Iowans have chosen these grandmothered health plans that meet
                                      their individual needs. Currently, grandmothered health plans’ existence is deter-
                                      mined by the Department of Health and Human Services (HHS) through the Cen-
                                      ters for Medicare and Medicaid Services (CMS) annually through non-enforcement
                                      extensions. If confirmed, are you committed to maintaining these affordable, con-
                                      sumer-chosen health plan options for Iowans by extending the non-enforcement au-
                                      thority?
                                        Answer. Making sure that all Americans have access to quality, affordable health
                                      care is one of the Biden administration’s top priorities. If confirmed, I will examine
                                      rules and other policies to ensure all Americans can access the care that they need.
                                        Question. Since this COVID–19 pandemic began, the Department of Health and
                                      Human Services (HHS) including within the Centers for Medicare and Medicaid
                                      Services (CMS) has provided health-care providers and patients many flexibilities
                                      under the public health emergency authority including over 80 services now fur-
                                      nished through telehealth for Medicare patients. A Centers for Disease Control and
                                      Prevention (CDC) Morbidity and Mortality Weekly Report found the use of tele-
                                      health increased 154 percent during the last week of March 2020 during the emer-
                                      gency of COVID–19 compared to the same period in 2019. We know the use of tele-
                                      health has continued throughout the COVID–19 pandemic. The data and response
                                      from patients and providers prove permitting telehealth services is a positive action
                                      to improve access and care. This last Congress, we provided permanent coverage for
                                      mental health telehealth visits under Medicare, which is helpful during the pan-
                                      demic and will remain critical for many Americans afterwards. If confirmed, are you
                                      committed to working with Congress and in the executive branch to extend tele-
                                      health flexibilities in Medicare beyond the pandemic? Additionally, some providers,
                                      including community health centers, face regulatory barriers based on provider type




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                                      or site of service. If confirmed, do you support removing those telehealth barriers
                                      for certain providers?
                                         Answer. Telehealth is an important tool to improve health equity and access to
                                      health care. Health care should be accessible, no matter where you live. If con-
                                      firmed, I would look forward to working with you and my colleagues at the Centers
                                      for Medicare and Medicaid Services on this issue.
                                        Question. As a direct result of the Affordable Care Act’s one-size-fits-all approach,
                                      many Iowans have been priced out of health insurance. To rectify this, the Trump
                                      administration and Iowa Insurance Division enabled Iowans more choice and com-
                                      petition in the health-care marketplace by enabling and expanding short-term
                                      limited-duration insurance (STLDI). This gives Iowans access to health insurance
                                      with consumer protections. If confirmed, will you work to maintain, modify, or re-
                                      scind the current regulations enabling Americans to purchase STLDIs?
                                        Answer. Making sure that all Americans have access to quality, affordable health
                                      care is one of the Biden administration’s top priorities. If confirmed, I will examine
                                      rules and other policies to ensure that plans provide Americans access to the care
                                      that they need.
                                         Question. It is important to give people affordable options for health insurance.
                                      Small business owners, like Iowa farmers, want to be able to provide insurance for
                                      their employees. Association Health Plans are a way for these small businesses to
                                      band together to expand access to health insurance and drive down costs. I have
                                      introduced legislation and support efforts to expand the pathway to affordable and
                                      accessible health care remaining open to employees across America. Association
                                      Health Plans allow small businesses to join together to obtain affordable health in-
                                      surance as though they were a single large employer. The coverage offered to asso-
                                      ciation members is subject to the consumer protection requirements that apply to
                                      the nearly 160 million Americans who receive coverage from large employers. If con-
                                      firmed, will you work to maintain, modify, or rescind current regulations enabling
                                      employers and employees access to Association Health Plans?
                                        Answer. Making sure that all Americans have access to quality, affordable health
                                      care is one of the Biden administration’s top priorities. If confirmed, I will examine
                                      all rules and policies to ensure all Americans can access the care that they need.
                                         Question. I support access to affordable health-care coverage for all Iowans, re-
                                      gardless of their health status or pre-existing conditions. Americans want to be in
                                      control of their own health care. National, single-payer health systems do not allow
                                      that. The Affordable Care Act took options away from people and adopting a single-
                                      payer system will make that worse. A national, single-payer health system would
                                      eliminate private health insurance for nearly 200 million Americans and require
                                      middle-class Americans to pay much more in taxes. Single-payer health care would
                                      also dramatically increase government spending substantially, fail to meet patient
                                      needs quickly, reduce provider payments rates and reduce quality of care, and the
                                      government would have more control over health care. It also threatens the benefits
                                      that current seniors on Medicare have paid into the system their entire working
                                      lives. If confirmed, do you intend to take administrative actions to implement the
                                      vision of a one-size-fits-all government-run health-care scheme like single-payer? If
                                      so, please describe what authority you believe you have to take such actions?
                                         Answer. President Biden has made it very clear that his goals for improving the
                                      American health-care system begin with building on the successes of the Affordable
                                      Care Act, and I am committed to working toward that goal.
                                         Question. If confirmed, will you take actions that stifle innovation and competition
                                      in health care?
                                         Answer. I believe it is important to foster innovation and competition in our
                                      health-care system. Americans should have access to health-care services and prod-
                                      ucts at an affordable price.
                                         Question. In 2019, the Trump administration issued two rules requiring price
                                      transparency for hospitals and health plans. The rules took effect in January 2021.
                                      This effort shines a light on the health-care industry that is all too often shrouded
                                      in secrecy. While Congress can build upon the rules, consumers can finally see sun-
                                      shine in health-care pricing. I have cosponsored legislation to codify the two health-
                                      care price transparency rules. This transparency will bring more accountability and
                                      competition to the health-care industry. Consumers should have the ability to com-
                                      pare health-care prices online so they can make an informed choice about what’s




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                                      best for them and their families. If confirmed will you modify, rescind, or maintain
                                      the Trump administration’s health-care price transparency regulations?
                                         Answer. If I am fortunate enough to be confirmed, I will ensure that the Depart-
                                      ment continues to take steps to improve price transparency, so consumers can look
                                      behind the curtain to understand how providers and insurers are operating.
                                         Question. Some States have lacked transparency in reporting their nursing home
                                      COVID–19 deaths data. For example, the State of New York undercounted nursing
                                      home deaths by as much as 50 percent and State officials intentionally withheld
                                      data for months. The New York Attorney General Letitia James released a report
                                      in January 2021 suggesting that many nursing home residents died from COVID–
                                      19 in hospitals after being transferred from their nursing homes. These figures were
                                      not reflected in the New York Department of Health’s nursing home death figures
                                      for many months suggesting the State was undercounting by as much as 50 percent.
                                      There are also reports finding New York State officials including members of New
                                      York Governor Andrew Cuomo’s staff intentionally withheld data on COVID–19-re-
                                      lated deaths in the State’s nursing homes. Following the release of the New York
                                      Attorney General report, the New York Department of Health reported 12,743 nurs-
                                      ing home residents occurred. This included an additional 3,829 confirmed COVID–
                                      19 fatalities of those residents who had been transported to hospitals. I have warned
                                      President Biden that an across-the-board termination of 56 U.S. attorneys could im-
                                      peril ongoing sensitive investigations. This concern has been expressed by Senate
                                      Democrats. Currently, Toni Bacon is serving as the U.S. attorney for the Northern
                                      District of New York. Ms. Bacon previously served as Justice Department’s national
                                      elder justice coordinator and who currently has jurisdiction over Federal public cor-
                                      ruption crimes in the State. Bacon is the obvious choice to continue a fair and unbi-
                                      ased investigation into possible violations of civil liberties of the elderly and the
                                      public corruption. Do you believe Department of Justice must have a fair, unbiased,
                                      and experienced U.S. Attorney in the Northern District of New York, such as Ms.
                                      Bacon?
                                         Answer. I defer to the Department of Justice on the selection of U.S. attorneys.
                                         Question. I led an effort in the Senate making additional resources available to
                                      support elder justice initiatives that assist older Americans especially throughout
                                      the COVID–19 pandemic. During the 116th Congress, as Senate Finance Committee
                                      chairman, I convened two hearings on elder justice initiatives and gaps in nursing
                                      home oversight. In December 2020, I urged Senate leadership to make resources
                                      available for regional or statewide strike teams to support nursing homes in crisis
                                      during this pandemic. Through this work, the end-of-year COVID–19 relief package
                                      included $100 million to support elder justice initiatives, including $50 million for
                                      State adult protective service agencies as they cope with unique challenges of serv-
                                      ing vulnerable populations during the pandemic. This work includes nursing home
                                      strike teams who have provided needed support when an outbreak occurs at a nurs-
                                      ing home or when additional resources are needed to meet the infection control or
                                      diagnostic testing requirements. Have State or Federal nursing home strike teams
                                      been effective at controlling outbreaks and protecting vulnerable Americans? If so,
                                      can you describe how their work slowed the spread and protected lives?
                                         Answer. It has been heartbreaking to see how hard the COVID–19 pandemic has
                                      hit the Nation’s nursing homes. Nursing homes and long-term care facilities are the
                                      homes for some of our most vulnerable, and we must do everything we can to work
                                      to protect them and ensure that they are receiving high quality health care. In Wis-
                                      consin, we developed a variety of strategies, including surging staff and other re-
                                      sources to assist our skilled nursing facilities protect their residents from COVID–
                                      19. If I have the honor of being confirmed, I look forward to working on this issue
                                      and coordinating with the Centers for Medicare and Medicaid Services.
                                         Question. The global pandemic has exposed grave concerns our society must con-
                                      front to protect the Nation’s most vulnerable citizens. Approximately 1.4 million
                                      Americans live in about 15,000 nursing homes across the country. Many Iowans
                                      have a loved one who lives in a long-term care facility. In 2019, as chairman of the
                                      Senate Finance Committee, I conducted a series of hearings to examine gaps in en-
                                      forcement of nursing home abuse. A Government Accountability Office (GAO) inves-
                                      tigation found a 103-percent increase in abuse deficiencies between 2013 and 2017.
                                      The GAO noted abuse in nursing homes is often underreported. The report docu-
                                      mented physical, mental, verbal, and sexual abuse perpetrated against residents.
                                      The number of nursing home deaths attributed to COVID–19 delivers a wake-up
                                      call we can’t afford to ignore. The Federal Government needs to do a better job en-
                                      forcing compliance with standards of care. When a loved one requires a long-term




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                                      care facility to deliver around-the-clock services, every family deserves peace of
                                      mind that every nursing home resident will receive high-quality, compassionate care
                                      and be treated with dignity and respect. If confirmed, how will you, as Deputy Sec-
                                      retary, ensure nursing homes uphold the standard of care that is necessary while
                                      not placing onerous requirements and excessive administrative burdens on nursing
                                      home staff ?
                                         Answer. Thank you for your longstanding leadership on this issue. Nursing homes
                                      and long-term care facilities are the homes for some of our most vulnerable, and
                                      we must do everything we can to work to protect them. If I have the honor of being
                                      confirmed, I look forward to coordinating with colleagues at the Centers for Medi-
                                      care and Medicaid Services to improve the safety and quality of care for residents
                                      of nursing homes.
                                                                                   ----
                                                             QUESTIONS SUBMITTED BY HON. JOHN CORNYN
                                                                      FOREIGN THREATS TO RESEARCH

                                         Question. Ms. Palm, in 2019, this committee held a hearing on foreign threats to
                                      taxpayer-funded research after multiple reports of espionage by the People’s Repub-
                                      lic of China. We have seen attempts by foreign entities like North Korea to steal
                                      intellectual property related to COVID vaccine development and I continue to hear
                                      concerns from research institutions in Texas.
                                         Do you believe that NIH and other funders of public research should consider cy-
                                      bersecurity protocols that institutions have in place when evaluating applications
                                      for research grant funds?
                                         What additional initiatives are you considering to ensure taxpayer funded re-
                                      search is protected from foreign threats?
                                         Answer. Protecting the integrity of taxpayer funded biomedical research is a mat-
                                      ter of great importance. I am committed to working with Congress, the NIH, and
                                      the HHS Office of National Security to ensure appropriate safeguards are in place
                                      to enhance and protect the security and the integrity of U.S. biomedical research.
                                                                                SUPPLY CHAIN

                                         Question. Regarding further distribution of personal protective equipment (PPE)
                                      and COVID–19 vaccines and ancillary products, how will government coordination
                                      with the private sector be managed? How will updates and information be commu-
                                      nicated to the healthcare supply chain in a timely manner?
                                         Answer. The global pandemic has highlighted the vulnerabilities of the health-
                                      care supply chain for many products. In order to continue responding to the
                                      COVID–19 pandemic and better prepare the Federal Government to respond to any
                                      future public health emergencies, it is critical that HHS work to improve and ex-
                                      pand health-care supply chain capabilities. If confirmed, I’m committed to working
                                      in coordination with the private sector on this urgent matter.
                                         Question. How does the new administration plan to coordinate with and leverage
                                      the expertise of the commercial healthcare supply chain to get product the last mile
                                      and get supplies into providers’ hands across the care continuum?
                                         Answer. Coordination across departments, agencies, and industries is key to en-
                                      sure the adequacy of the health-care supply chain. If confirmed, I’m committed to
                                      working on this urgent matter.
                                         Question. Once the COVID–19 pandemic is under control, how do you anticipate
                                      partnering with the commercial supply chain to ensure that the country is ready
                                      for the next public health emergency? Have you considered solutions such as a ‘‘ven-
                                      dor managed inventory’’ solution to help guarantee that non-expired product could
                                      be available on demand?
                                         Answer. As the Nation continues to turn the corner on the COVID–19 pandemic,
                                      it is important to think ahead to the next public health emergency. If confirmed,
                                      I will work with the Assistant Secretary of Preparedness and Response (ASPR) to
                                      ensure these efforts can increase the Nation’s ability to meet demand in future cri-
                                      ses.
                                         Question. How does the Biden administration intend to use the DPA authority
                                      and will the administration do so with thoughtful consideration of those with exper-




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                                      tise in the medical supply chain so the existing infrastructure and supply are aug-
                                      mented rather than duplicated?
                                         Answer. If confirmed, I commit to working closely with members of this committee
                                      on efforts related to the COVID–19 response, including the use of Defense Produc-
                                      tion Act and its potential impacts.
                                                                                    HOSPICE

                                        Question. Within the Medicare program, State survey agencies (SAs) are overbur-
                                      dened and often lack the capacity to respond to survey complaints in a timely and
                                      appropriate manner. The ability to respond to and correct issues arising from com-
                                      plaints is imperative, particularly for terminally ill beneficiaries in hospice. Accredi-
                                      tation Organizations (AOs) are also authorized to conduct complaint surveys. Ex-
                                      panding the use of qualified AOs that are trained in hospice would alleviate State
                                      regulatory burden, while continuing to ensure that all complaints are addressed in
                                      timely coordination with the SAs and CMS. The expanded use of AOs would lead
                                      to increased transparency and emphasize savings in the hospice community.
                                        How does the administration plan to emphasize the services of Accreditation Or-
                                      ganizations for hospice complaint surveys to relieve State regulatory burden and im-
                                      prove timely beneficiary safety and quality?
                                        Answer. Improving the safety and quality of care for American patients is critical,
                                      including in hospice settings. If confirmed I will work with my colleagues in the
                                      Centers for Medicare and Medicaid Services to make sure complaints are followed
                                      up on in a timely manner.
                                        Question. The Hospice Act brought attention to the need for Medicare surveyors,
                                      who are often State surveyors, to specifically be trained for the hospice population.
                                      Similar gaps in knowledge and judgement occur among the medical reviewers for
                                      OIG, MAC and Program Integrity hospice audits often driven by a similar hospice
                                      knowledge gap and compounded by a chart review that can never replicate the hos-
                                      pice program physician’s real time medical prognostication of the patients at the end
                                      of life. When payment denials are appealed by the hospice provider, most are over-
                                      turned on appeal, an expensive and time-consuming process for both hospices and
                                      HHS.
                                        I understand the need for program integrity, but we cannot place so much of a
                                      burden that it creates an issue for providers that could turn into an access issue
                                      for these vulnerable beneficiaries. How will HHS address the gap in knowledge of
                                      Medicare medical reviewers, who frequently look past the certifying physician’s
                                      medical judgment as reflected on the Certification of Terminal Illness (CTI); perhaps
                                      especially when the physician record entries as to the basis for prognostication are
                                      not as detailed as the Medicare reviewer believes was warranted.
                                        Answer. Thank you for bringing up this issue. If confirmed, I certainly want to
                                      look for any ways to be more efficient and improve processes, and I will work with
                                      my colleagues at the Centers for Medicare and Medicaid Services to find ways to
                                      improve the Medicare program.
                                                                               CHILDREN’S HEALTH

                                         Question. As HHS Secretary, you will oversee a number of programs and agencies
                                      important to children from health coverage programs vital to children’s health such
                                      as Medicaid and the Children’s Health Insurance Program (CHIP) to programs re-
                                      sponsible for training the pediatric health-care workforce like the Children’s Hos-
                                      pital Graduate Medical Education Program (CHGME) to pediatric research initia-
                                      tives at the National Institutes of Health.
                                         What are your priorities for child health if confirmed?
                                         Answer. Programs such as Medicaid and the Children’s Health Insurance Pro-
                                      gram (CHIP) are critical programs that help ensure that children have adequate ac-
                                      cess to quality health care. If confirmed, I would work to ensure children are receiv-
                                      ing necessary health care through both programs. I would also look to better ensure
                                      access to oral health and vision care for children, as both are necessary for children
                                      to thrive in school. And we cannot forget that improving child health begins with
                                      ensuring maternal health. I will work tirelessly to reduce maternal and infant mor-
                                      tality and morbidity, using the expertise and resources across HHS.
                                         Further, many other agencies of HHS work improve the lives of children in mat-
                                      ters beyond that of health-care coverage. For example, the Children’s Bureau part-
                                      ners with Federal, State, tribal, and local agencies to improve the overall health and




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                                      well-being of our Nation’s children and families. I look forward to working with Con-
                                      gress, and with State and local partners to make sure that we are doing all we can
                                      to improve child health in this country.
                                        Question. Medicaid and CHIP are critical programs for children, providing cov-
                                      erage for over 40 million children. Medicaid is also the backbone of the pediatric
                                      health-care system providing care across the continuum from screenings and pre-
                                      ventive to highly specialized diagnoses and treatments.
                                       What are your plans to strengthen this safety net for children and the providers
                                      who care for them?
                                        Answer. If confirmed, I would work to support and strengthen Medicaid and
                                      CHIP, as well as other programs for children, to ensure that children have adequate
                                      access to quality health care. In particular, I would look to better ensure access to
                                      oral health and vision care for children, while working to reduce maternal and in-
                                      fant mortality and morbidity, as well as programs that ensure the safety of well-
                                      being for children and families. If confirmed, I lookforward to working with you to
                                      make sure our children have access to quality care and are able to thrive.
                                        Question. The pandemic is having a profound impact on children’s health and the
                                      providers who care for them.
                                         What are your immediate plans to address the current crisis in the increasing
                                      number of children facing severe mental, emotional and behavioral health chal-
                                      lenges due to social isolation and the serious impact of the pandemic on the health
                                      of their families and caregivers?
                                         Answer. I am deeply concerned about the impact of the COVID–19 pandemic on
                                      the mental, emotional, and other behavioral health outcomes of our children, their
                                      families and caregivers. I agree this must be an urgent national priority. If con-
                                      firmed, I commit to working on this issue and I would seek to ensure collaboration
                                      across HHS agencies, including CMS and SAMHSA, to ensure we are fully lever-
                                      aging CHIP and Medicaid, and that we do a better job of tackling this important
                                      issue.
                                        Question. The pediatric health-care safety net has been affected by the pandemic
                                      in different ways then the adult health-care system, with less direct Federal finan-
                                      cial support because they are not eligible for Medicare funding streams. What are
                                      your plans to sustain a stable pediatric health-care system now and beyond the pan-
                                      demic?
                                        Answer. Medicaid and CHIP are lifelines to children and help form the fabric of
                                      the pediatric health-care safety net. Over 77 million individuals are enrolled in
                                      those programs, and about half are children. It is critical that we work to support
                                      our pediatric health-care safety net and pediatric health-care providers during the
                                      COVID–19 pandemic and beyond. If confirmed, I would make it a priority to work
                                      across HHS and with States to provide necessary support to pediatric providers.
                                        Question. The Children’s Hospital Graduate Medical Education Program
                                      (CHGME) provides significant support for the training of pediatricians and pediatric
                                      specialists. But unfortunately, the funding for this program still lags far behind the
                                      Medicare GME program—funding only half of what Medicare GME provides per
                                      resident.
                                        What are your plans to address this gap in training support for our Nation’s pedi-
                                      atric workforce?
                                        Answer. If confirmed, I would work with the resources across the Department and
                                      with States to support the health-care workforce, including those who work with pe-
                                      diatric populations.
                                        Question. During the pandemic, telehealth has played a major role in providing
                                      access to care for Medicaid beneficiaries, including children.
                                        How will HHS support the continued use and enhancements needed under Med-
                                      icaid to ensure telehealth continues to enable access to care for children?
                                        Answer. Telehealth is an important tool to improve health equity and improve ac-
                                      cess to health care. Health care should be accessible, no matter where you live.
                                      Under current law, States have a great deal of flexibility with respect to delivering
                                      Medicaid services via telehealth. Medicaid has made great strides in expanding
                                      services available through telehealth, including pediatric services, during the public
                                      health emergency. If confirmed, I will work with CMS to determine how we can




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                                      build on this work to improve health equity and improve access to health care for
                                      children.
                                        Question. As you know, pediatric health care is organized differently than adult
                                      health care. Pediatric care is more regionalized and often results in children, espe-
                                      cially those with complex health needs, having to travel across State lines for care.
                                      Under Medicaid, this can be challenging for them and their providers with different
                                      policies State to State. The ACE Kids Act passed in 2019 and is effective next year,
                                      is one step in addressing these inconsistencies and getting much needed national
                                      data to inform care improvements.
                                        If confirmed, how would you approach these cross-State challenges that children
                                      with complex needs face when traveling for needed care?
                                        Answer. Medicaid and CHIP are crucial to ensuring children have adequate access
                                      to quality health care, especially those with complex needs. If confirmed, I will work
                                      closely with CMS as well as across the Department to ensure children are receiving
                                      necessary health care. I look forward to working across the administration and with
                                      Congress to make informed decisions that address the specific needs of children
                                      with complex medical conditions.
                                        Question. Oftentimes, changes in the larger health-care landscape take place, for
                                      example in the Medicare program, without a full examination of how these changes
                                      could potentially impact children, even inadvertently. At times, Medicare policies de-
                                      signed with the elderly population in mind have been applied to Medicaid or adopt-
                                      ed by State Medicaid programs and private payers.
                                        As you look at health-care changes at the national level as HHS Secretary, how
                                      will you ensure that children’s unique health-care needs are taken into account?
                                        Answer. If confirmed, I will work with Congress and States to spur and encourage
                                      innovation in these important programs. Innovative delivery system and payment
                                      models are vital to ensuring that Medicaid and CHIP are equipped to address
                                      emerging pediatric health issues and can continue to provide children with access
                                      to quality health care.
                                        Question. A major focus in health care among policy makers has been on pursuing
                                      delivery system reforms that improve quality and reduce costs. The Federal Govern-
                                      ment has traditionally focused more on adult populations rather than the needs of
                                      children in these reforms. As a result, Medicaid for children still lags behind Medi-
                                      care in supporting improvements in care and innovative payment models.
                                         What steps will you take to promote increased emphasis on these types of innova-
                                      tions in Medicaid targeting the unique needs of children?
                                        Answer. If confirmed, I will work with Congress and States to spur and encourage
                                      innovation in these important programs. Innovative delivery system and payment
                                      models are vital to ensuring that Medicaid and CHIP are equipped to address
                                      emerging pediatric health issues and can continue to provide children with access
                                      to quality health care.

                                                                                   ----

                                                             QUESTIONS SUBMITTED BY HON. RICHARD BURR
                                                                     COUNTERMEASURE DEVELOPMENT

                                         Question. Platform technologies or innovative delivery platforms, such as a vac-
                                      cine or therapeutic administered through a patch, that can deliver medicine to pa-
                                      tients in certain circumstances, provide promising alternatives to traditional med-
                                      ical treatments. These platform technologies could provide a way to deliver vaccina-
                                      tions to patients. An innovation that provides a vaccine dose through a patch plat-
                                      form could replace or provide an alternative to vaccines injected via needles. A patch
                                      delivery platform does not need to be frozen, may require less ancillary medical sup-
                                      plies, and could be self-administered at home. If these characteristics were in place
                                      for a countermeasure, public health and health-care organizations could distribute
                                      vaccine or therapeutic doses more widely, improving access to underserved or hard
                                      to reach communities.
                                        How will this administration support the development of alternative delivery plat-
                                      forms for vaccines and other countermeasures, such as shelf-stable, self-applied
                                      patches during COVID–19?




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                                         How will this administration support expanding the use of alternative vaccine de-
                                      livery platforms for future pandemic needs?
                                         Answer. I agree that we must do all we can to improve vaccine technology and
                                      make vaccines easier to deliver. If confirmed, I will work with NIH and FDA, as
                                      well as our international partners, to ensure we take any steps needed to help facili-
                                      tate the development, review, and approval of new vaccine technologies.
                                                                               SYNTHETIC BIOLOGY

                                         Question. President Biden, in his remarks on the American Jobs Plan, stated
                                      ‘‘China . . . is racing ahead of us in the investments they have in the future.’’ Syn-
                                      thetic biology is an emerging field which, with the appropriate regulatory oversight
                                      and investment, has the potential to provide high-paying U.S. jobs and supply chain
                                      security. How will HHS encourage the development of synthetic biology and appro-
                                      priately evaluate the evolving science to ensure a regulatory approach that does not
                                      hamper innovation?
                                         Answer. Synthetic biology is an important, growing field and, if confirmed, I look
                                      forward working across HHS to support U.S. leadership in this space.
                                                                                   ----
                                                          QUESTIONS SUBMITTED BY HON. PATRICK J. TOOMEY
                                         Question. Over 2 months ago, my staff requested certain documents from the De-
                                      partment of Health and Human Services commonly referred to by the previous ad-
                                      ministration as ‘‘weekly draw down reports.’’ These reports provide some insight
                                      into the allocation of Federal funding and subsequent spending by the States as it
                                      relates to COVID–19 supplemental appropriations. It is my understanding that
                                      these reports have been shared with other members of this chamber and are gen-
                                      erally used for press inquiries. However, to date, my office has not received these
                                      reports despite repeated follow-ups with multiple staff members in the Department.
                                         I think we can both agree that transparency is a good thing—particularly when
                                      it involves trillions of taxpayer dollars. If you are confirmed, will you commit to
                                      making public the funding appropriated, obligated, and spent on COVID–19 relief
                                      in a manner that is easily accessible and understood by the general public? Further,
                                      will you commit to providing weekly draw down reports with Congress on a weekly
                                      basis?
                                         Answer. If confirmed, I commit to reviewing your request and providing this com-
                                      mittee with information relevant to its oversight functions.
                                         Question. During your time as Secretary-designee, on multiple occasions you at-
                                      tempted to bypass the Wisconsin State legislature or exceeded your authority to ex-
                                      tend State-wide stay-at-home orders during the COVID–19 pandemic. In May 2020,
                                      the Wisconsin Supreme Court struck down Emergency Order #28 because you ex-
                                      ceeded your statutory authority and you did not follow statutory emergency rule-
                                      making procedures established by the State legislature. This order would have ex-
                                      tended a previous executive order which confined all people to their homes, forbid
                                      travel, and closed businesses, but it also went a step further by establishing a crimi-
                                      nal penalty for violators. Many months later, on October 6, 2020, you signed another
                                      emergency order to limit the number of people in certain public indoor businesses
                                      and private gatherings. The order would have also implemented a fine for violators.
                                      At a press conference on the same day, you even encouraged local governments to
                                      go further and offer more restrictive orders. The non-partisan Wisconsin Legislative
                                      Reference Bureau (WLRB) reviewed this order and determined it needed to be pro-
                                      mulgated as a rule. A lawsuit was subsequently filed by the Wisconsin Tavern
                                      League on October 12, 2020, arguing that you once again exceeded your statutory
                                      authority and did not follow emergency rule making procedures established by the
                                      State legislature. On April 14, 2020, the Wisconsin Supreme Court ruled the emer-
                                      gency order violated State law and was not validly enacted.
                                         If confirmed, how can I be assured of your compliance with Federal laws even if
                                      those laws are not popular within your own political party? Further, do you commit
                                      to abiding by the Administrative Procedure Act when enacting rules and regula-
                                      tions?
                                         Answer. If confirmed, I will follow the law.
                                         Question. Nearly 120,000 children enrolled in Medicaid across the Appalachian re-
                                      gion received at least one opioid prescription in 2018. In some States, the share of




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                                      child beneficiaries receiving at least one prescription opioid outpaced that of adult
                                      beneficiaries. This reckless prescribing puts Medicaid beneficiaries at risk of misuse
                                      and overdose. Despite research demonstrating nonfatal overdoses are among the
                                      most significant predictors of a future overdose, the Medicaid program has persist-
                                      ently failed to help enrollees in these circumstances. In fact, a study of 3,606 Med-
                                      icaid enrolled adolescents (ages 13–22) who experienced an opioid-related overdose
                                      found that only one in 54 received medication-assisted treatment, and less than one
                                      in three received any treatment whatsoever. Equally concerning, Medicaid bene-
                                      ficiaries often receive a legal opioid prescription even after suffering a nonfatal,
                                      opioid-related overdose.
                                         Senator Joe Manchin (D–WV) and I will be reintroducing the IMPROVE Addiction
                                      Care Act this Congress. This legislation fixes a problem in the Medicaid program
                                      that fails to identify victims of previous overdoses and ensure prescribers are noti-
                                      fied of their patients’ fatal overdoses. Our legislation is supported by a handful of
                                      advocacy and provider groups including Shatterproof, Faces and Voices of Recovery
                                      and the American Society of Addiction Medicine (to name a few).
                                        In your previous role as Secretary-designee, what efficiencies did you bring to
                                      Wisconsin’s Medicaid program that directly benefited individuals suffering from sub-
                                      stance use disorder (SUD)? How did you reduce the silos associated with their care
                                      to help connect enrollees to SUD treatment? Please be specific.
                                        Answer. This was a crisis before the pandemic. And now we know COVID–19 has
                                      taken a toll on Americans in so many different ways. Like President Biden, I am
                                      committed to addressing the substance use disorder epidemic and to making sure
                                      patients have access to prevention, treatment, and recovery services. In Wisconsin,
                                      I was proud to work with Republicans in the State legislature to enact telehealth
                                      legislation, that among other things, improved access to substance use disorder
                                      treatment in rural and underserved communities. In addition, we launched a hub
                                      and spoke model to better integrate behavioral health treatment within health care
                                      to reduce barriers to care, break down silos and better coordinate care for Medicaid
                                      beneficiaries. If I have the honor of being confirmed, I look forward to partnering
                                      with you to continue to work on this important issue.
                                        Question. In your testimony, you highlight bipartisan work in your role at the De-
                                      partment of Health and Human Services under the Obama administration. How-
                                      ever, it does not specify bipartisan work performed in your most recent role at as
                                      Secretary-designee.
                                        What were some of your bipartisan accomplishments with the Republican-
                                      controlled State legislature in Wisconsin? What major compromises have you had
                                      to make in order to improve Wisconsin’s health-care system? Please be specific.
                                        Answer. I am proud of the work I was able to accomplish in Wisconsin. There,
                                      we secured bipartisan expansion and modernization of telehealth in the Medicaid
                                      program and bipartisan policy changes to Wisconsin’s Children’s Health Insurance
                                      Program (CHIP). We also worked in a bipartisan work manner to integrate a hub
                                      and spoke model of behavioral health treatment and stand up a residential treat-
                                      ment benefit—both of these initiatives improved access to substance use disorder
                                      treatment in Wisconsin. In all of my work, I prioritized judicious use of taxpayer
                                      dollars and working with members of both parties to improve health care for Wis-
                                      consin families.
                                        Question. In your testimony, you highlight reducing ‘‘the cost of prescription
                                      drugs’’ as one of your public health priorities.
                                           What policies do you support to reduce the cost of prescription drugs?
                                        Answer. I believe we must do all we can to lower the costs of prescription drugs
                                      and make them more accessible for Americans who depend on them. I am com-
                                      mitted to finding ways to reduce drug prices and ensure Americans have access to
                                      the drugs that they need. If confirmed as Deputy Secretary of HHS, I look forward
                                      to working with you and others in Congress to achieve these important goals. I will
                                      also work across the government to address barriers to reducing drug prices.




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                                                               QUESTIONS SUBMITTED BY HON. TIM SCOTT
                                                ON RELIGIOUS LIBERTY, LOCKDOWN ORDERS, AND REOPENING SCHOOLS

                                         Question. During your nomination hearing, you framed your priorities as part of
                                      a ‘‘common-ground agenda.’’ I appreciate this approach, and if you are confirmed,
                                      I look forward to working with you to advance a number of your stated goals, in-
                                      cluding, most immediately, a robust scale-up in vaccinations. Bipartisan collabora-
                                      tion has tremendous value as we seek to end the pandemic, bolster our economy,
                                      and increase access to health care. That said, some of my constituents have ex-
                                      pressed serious concerns with your nomination, primarily focused on two key issues.
                                        First, with respect to religious liberty, you faced substantial pushback from con-
                                      servatives and pro-life advocates during your tenure at Wisconsin’s health depart-
                                      ment, based in part on your selection of a longtime Planned Parenthood lobbyist to
                                      serve as your deputy, as well as what some Wisconsin lawmakers have described
                                      as vague or noncommittal responses around the use of public funds for abortion.
                                      Early in the pandemic, a number of State legislators also took issue with the ability
                                      of abortion clinics to continue operating and using needed medical supplies, even as
                                      countless entities across the State were forced to shutter under your shelter-in-place
                                      order. Many South Carolinians have cited these controversies as significant cause
                                      for concern, particularly given HHS’s role in overseeing a broad range of programs
                                      with profound implications for religious liberty and human life.
                                         Since long before I came to Congress, I have prioritized protections for religious
                                      liberty and freedom of conscience, one of our core constitutional rights. I have also
                                      been a committed defender of all human life, including the lives of the unborn.
                                        Prior to taking any actions with implications for people of faith, can you commit
                                      to consulting and engaging with religious liberty advocates, including those who dis-
                                      agree with your previously stated positions on the issues above?
                                        If confirmed, can you commit, through all of your actions as Deputy Secretary of
                                      HHS, to uphold religious liberty and freedom of conscience for all Americans, includ-
                                      ing those with deeply held religious convictions and beliefs?
                                        Answer. If confirmed, I commit to thoroughly consulting stakeholders and a di-
                                      verse set of voices on all relevant issues. If confirmed, I will follow the law.
                                         Question. I have also heard from constituents across the Palmetto State with con-
                                      cerns regarding the shelter-in-place order that you issued in Wisconsin on April
                                      16th of last year, which many have described as overreaching and arbitrary. In ad-
                                      dition to banning non-essential travel, extending a sweeping shutdown of diverse
                                      businesses, and placing severe restrictions on gatherings, the order in question
                                      adopted steep penalties for violations, with fines of $250 and imprisonment of up
                                      to 30 days on the table. The Wisconsin Supreme Court majority agreed with the or-
                                      der’s critics, with Justice Roggensack writing, in enjoining the order, ‘‘Rule-making
                                      exists precisely to ensure that kind of controlling, subjective judgment asserted by
                                      one unelected official, Palm, is not imposed on Wisconsin.’’ The court’s ruling caught
                                      the attention of The Wall Street Journal’s editorial board, which celebrated the deci-
                                      sion in an op-ed entitled ‘‘Democracy Lives in Wisconsin,’’ concluding that
                                      ‘‘[d]emocracy and the rule of law don’t end because there’s a pandemic.’’
                                         You were not alone, particularly among blue-State officials, in issuing and extend-
                                      ing far-reaching lockdown orders, and the tumultuous early days of the pandemic
                                      triggered a number of bold decisions across the Nation, many of which look more
                                      rash or counterproductive in retrospect than they might have appeared at the time.
                                      At the same time, lockdowns have led to dire consequences for scores of Americans,
                                      particularly in the case of vulnerable communities. We have seen unprecedented
                                      learning losses for young people, along with spikes in suicide, deaths of despair, and
                                      economic insecurity.
                                         As you reflect on the past year, what are some of the areas where you might, in
                                      retrospect, have revised your approach to pandemic response, and what would you
                                      cite as some of the lessons learned?
                                         In a letter to the chairman and ranking member, two members of the House who
                                      served in Wisconsin’s State government during your time as Secretary-designate al-
                                      leged that you ‘‘played a central role in the shuttering of Wisconsin schools for the
                                      final months of the 2019–2020 school year and led many throughout the State to
                                      operate in a hybrid or virtual learning model for 2020–2021.’’ How would you re-
                                      spond to these claims, and what steps do you believe that HHS should take, in con-




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                                      cert with other Federal agencies and with State and local authorities, to accelerate
                                      the reopening of K–12 schools for in-person learning?
                                        Answer. I am proud of the work I was able to accomplish in Wisconsin. Every sin-
                                      gle day, I got up and worked tirelessly to protect the health and well-being of the
                                      people of Wisconsin, especially as we navigated a public health crisis. If confirmed,
                                      I commit to working with the CDC and State and local leaders to ensure everyone
                                      has the resources and support necessary to ensure children nationwide are able to
                                      attend school safely, which is a top priority of the Biden administration.
                                                                   ON VACCINE TECHNOLOGY INNOVATION

                                        Question. Vaccine patches represent a promising alternative to traditional vac-
                                      cines injected via needles. Vaccine patches do not need to be frozen, do not use nee-
                                      dles, are single-dose, and can be self-administered at home. By reducing logistical
                                      challenge, wastage, and vaccine hesitancy, they could play a major role in improving
                                      our Nation’s response to the COVID–19 pandemic, as well as our preparedness for
                                      future pandemics.
                                        How will this administration support the development of alternative vaccine plat-
                                      forms, such as shelf-stable, self-applied patches?
                                        How will this administration support the expansion of use of alternative vaccine
                                      platforms for future pandemic needs?
                                        Answer. I agree that we must do all we can to improve vaccine technology and
                                      make vaccines easier to deliver. If confirmed, I will work with NIH and FDA, as
                                      well as our international partners, to ensure we take any steps needed to help facili-
                                      tate the development, review, and approval of new vaccine technologies.
                                                                       ON SUPPLY CHAIN RESILIENCY

                                         Question. President Biden, in his remarks on the American Job Plan, stated
                                      ‘‘China is racing ahead of us in the investments they have in the future.’’ Synthetic
                                      biology is an emerging field which, with the proper regulatory regime and invest-
                                      ment, will provide high-paying U.S. jobs and supply chain security.
                                        What legislative steps should Congress take to facilitate HHS development and
                                      support for the U.S. synthetic biology industry?
                                        Answer. I agree that synthetic biology is an area where the U.S. needs to be the
                                      world’s leader. I commit to work with you to determine what legislative or resource
                                      needs there may be at HHS to help make this a reality.
                                                                   ON SUPPORT FOR NURSING HOME I–SNPS

                                        Question. As you know, Institutional Special Needs Plans (I–SNPs) are a type of
                                      Medicare Advantage plan where the only beneficiaries enrolled are seniors living in
                                      nursing homes. When nursing homes offer these plans, they are 100 percent at risk
                                      for all the care their residents need, either at their facilities or elsewhere. In the
                                      push towards value-based care, nursing homes taking on risk via I–SNPs are doing
                                      exactly what we want to see, but in 2020, being 100 percent at risk for a population
                                      exclusively made up of the individuals most vulnerable to COVID–19, and most like-
                                      ly to need high-cost hospitalization, created serious financial challenges for nursing
                                      homes with I–SNPs, including numerous communities in South Carolina. While
                                      nursing homes in general have received funds from the Provider Relief Fund (PRF),
                                      neither HHS nor CMS has provided relief to address the specific challenges nursing
                                      home I–SNPs have faced in order to ensure this model’s continued viability.
                                        Will you commit to using administrative authority to support I–SNPs and to rec-
                                      ognize the significant increased and unexpected costs that these plans have faced
                                      during the COVID–19 emergency?
                                        Answer. It has been heartbreaking to see how hard the COVID–19 pandemic has
                                      affected the Nation’s nursing home residents. Nursing home care will absolutely be
                                      a focus of mine if confirmed. Medicare Advantage serves millions of Americans, and
                                      I understand that Institutional Special Needs Plans provide important options for
                                      people in need of the level of care provided in nursing homes and long-term care
                                      facilities. If I have the honor of being confirmed as Deputy Secretary, I will be
                                      happy to work on this issue along with my colleagues at the Centers for Medicare
                                      and Medicaid Services.




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                                                           QUESTIONS SUBMITTED BY HON. JAMES LANKFORD
                                        Question. I am concerned regarding inequities in the distribution of the Provider
                                      Relief Fund. Assisted living providers care for the population most vulnerable to
                                      COVID, yet have received far too little relief to date. In my State of Oklahoma, as-
                                      sisted living providers care for over 18,000 seniors in 194 facilities across the State.
                                      Unfortunately, assisted living providers were allocated less than 2 percent of the
                                      Provider Relief Fund (about $3 billion dollars) and have only received about a third
                                      of that. The average age of a resident in assisted living is 85. According to the CDC,
                                      this age group is 630 times more likely to die from COVID than a 29-year-old. In
                                      assisted living, these vulnerable individuals need assistance with daily activities
                                      such as eating, using the restroom, taking medications, and dressing. Social distanc-
                                      ing by their caregivers is not possible. Over 40 percent of assisted living residents
                                      have Alzheimer’s or some form of dementia. Due to PPE needs, workforce needs and
                                      occupancy declines, assisted living caregivers have incurred over $15 billion in
                                      losses. In Oklahoma, assisted living caregivers have suffered over $235 million in
                                      losses. Now, over half of assisted living facilities Nation-wide are operating at a loss,
                                      and 56 percent say they will not be able to sustain operations for another year.
                                        I recently signed a letter asking HHS Secretary Becerra to distribute more of the
                                      remaining PRF to assisted living facilities.
                                        Since you may be overseeing this distribution as well, will you commit to working
                                      with all long-term care providers to ensure our Nation’s most vulnerable are prop-
                                      erly cared for?
                                        Answer. If confirmed, I commit to working with all of our Nation’s front-line work-
                                      ers to ensure they receive the support and resources they need to care for those who
                                      rely on them.
                                        Question. I know that your home State of Wisconsin has some similarities to my
                                      State of Oklahoma in that we were both hit exceptionally hard by the opioid epi-
                                      demic.
                                        Please detail some of the solutions you will work on, if confirmed, to continue to
                                      combat the opioid epidemic.
                                        Answer. HHS has worked aggressively to address our Nation’s opioid epidemic.
                                      Progress was being made to increase access to evidence-based treatment and re-
                                      duced death by overdose until the pandemic hit. If confirmed, I will direct HHS
                                      agencies, including SAMHSA, HRSA, AHRQ, CDC, CMS, NIH, FDA and IHS, to
                                      work together and with ONDCP and other White House components, as well as with
                                      DOJ and other Federal entities, including VA and DOD, to increase access to pre-
                                      vention, early intervention, treatment, and recovery support programs. People with
                                      addiction to these powerful and tenacious drugs deserve access to the full range of
                                      evidence-based prevention, early intervention, treatment and ongoing recovery sup-
                                      ports. Substance use is a treatable condition. Through access to evidence-based pro-
                                      grams, people can and do recover.
                                                                                   ----

                                                             QUESTIONS SUBMITTED BY HON. STEVE DAINES
                                         Question. Throughout the pandemic, assisted living providers in my home State
                                      have cared for over 6,000 vulnerable Montanans—many who are living with Alz-
                                      heimer’s or some form of dementia. Due to PPE needs, workforce needs, and occu-
                                      pancy declines, I continue to hear that many of these providers have suffered mil-
                                      lions in losses throughout the pandemic and will struggle to sustain their operations
                                      without financial relief. There is roughly $23 billion remaining in the Provider Re-
                                      lief Fund to help support our healthcare heroes who are on the frontlines of the
                                      COVID response. I recently urged Secretary Becerra to distribute more of the re-
                                      maining PRF to assisted living facilities and other senior care centers.
                                         Do you support this request?
                                         Answer. If confirmed, I commit to working with all of our Nation’s front-line work-
                                      ers to ensure they receive the support and resources they need to care for those who
                                      rely on them.
                                         Question. For decades, the Federal Government has funded telehealth research
                                      grants. These grants have been administered by more than 10 agencies and oper-
                                      ating divisions across the Federal Government. Unfortunately, navigating the Fed-
                                      eral grant process can be a challenge for the average provider and health system.
                                      Also, despite the Federal Government funding significant amounts of telehealth




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                                      projects, we have very little data to point back to and it seems that grant programs
                                      can be duplicative or at odds with prior projects. Additionally, we know that there
                                      is still a learning curve for providers, patients and caregivers on telehealth. As we
                                      continue the shift toward a health-care system that will include virtual care perma-
                                      nently, I believe there is value in ensuring there is a function within HHS today
                                      to help with issues of digital literacy and education.
                                        Do you believe that we have a coordinated national telehealth strategy? Do you
                                      agree that a coordinated approach to telehealth investments and policies across at
                                      least HHS is important?
                                        Would it be beneficial for there to be an elevated presence within HHS leadership
                                      to coordinate telehealth investments and policy across the Federal Government?
                                        How can we improve digital health literacy for beneficiaries, caregivers and pro-
                                      viders alike? Do you agree that this should be a focus for HHS as telehealth policies
                                      are adopted permanently?
                                        Answer. Telehealth has been invaluable during this pandemic to keep patients,
                                      their providers and their families safe, while maintaining critical access to care. If
                                      confirmed, I will take a careful look at those telehealth flexibilities along with my
                                      colleagues at HRSA, SAMHSA, and CMS. I look forward to hearing more from you
                                      about what existing flexibilities you view as especially important.
                                         Question. About 46 million Americans, nearly 15 percent of the U.S. population,
                                      live in rural areas like my home State of Montana. 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
                                      many cases, primary care. Digital health tools, including telehealth and remote
                                      monitoring, have the potential to relieve some of the key healthcare challenges fac-
                                      ing rural America.
                                        Can you speak to the promise of telehealth and digital health care more broadly
                                      for rural communities?
                                        Answer. I believe that we have to take every approach we can to provide Ameri-
                                      cans access to quality health care, especially in rural areas, and telehealth is an im-
                                      portant tool to improve health equity and access to health care. Health care should
                                      be accessible, no matter where you live. If confirmed, I will look at how we can use
                                      telehealth to improve health equity and access to health care.
                                        Question. Virtual care can help address existing health disparities by eliminating
                                      the barriers of time, distance, and geography, while empowering patients to over-
                                      come the challenges of accessing in-person care, something Montanans know too
                                      well. One of the lessons learned from the COVID–19 pandemic is the value of
                                      leveraging telehealth to scale and meet rising demand for key health-care services.
                                      Health workforce shortages were at critical levels before COVID–19.
                                        I was pleased to lead the effort that resulted in section 3701 of the CARES Act,
                                      which created a temporary safe harbor that allows high-deductible health plans
                                      (HDHPs) to cover telehealth and remote care services prior to a patient reaching
                                      their deductible. This important safe harbor ensures that high-deductible health
                                      plans can support patients that are leveraging virtual care to access a range of crit-
                                      ical health-care services during the pandemic before the annual deductible is met.
                                      The CARES provision extended the safe harbor only through December 31, 2021.
                                        According to the Bureau of Labor Statistics (BLS), only 15 percent of workers em-
                                      ployed in the private sector participated in an HDHP in 2010. By 2018, that number
                                      had risen to 45 percent. Today, the number is estimated to be 54 percent. Impor-
                                      tantly, participation in HDHPs is even across wage groups and in industries with
                                      a significant proportion of black and Hispanic workers.
                                        As the U.S. health-care system emerges from the pandemic, permanently extend-
                                      ing the HDHP/HSA Telehealth Safe Harbor would allow half of American workers
                                      to continue accessing a range of clinically appropriate virtual services—for a range
                                      of common conditions—without the burden of first meeting a deductible. I look for-
                                      ward to working with my colleagues on this committee to support American workers
                                      and ensure this key policy continues beyond 2021.




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                                        Do you agree that there is value in expanding access to telehealth regardless of
                                      your health plan design?
                                        Answer. Telehealth has been invaluable during this pandemic to keep patients,
                                      their providers and their families safe, while maintaining access to critical health
                                      care. If I have the honor of being confirmed, I would be happy to work with you
                                      on ways to continue to improve access to care, including through telehealth.
                                         Question. One of the silver linings of this pandemic has been the widespread
                                      adoption of technology to bring people together, whether it be families scattered
                                      across the Nation or patients and their providers. Telehealth has truly taken root
                                      and we have seen exponential growth in telehealth adoption across Americans of all
                                      ages, locations and conditions. Much of the growth in usage among Medicare bene-
                                      ficiaries 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.
                                        Do you agree that the expanded access to telehealth services has been an impor-
                                      tant component in protecting patients and providers during the Nation’s response
                                      to COVID–19?
                                         As Congress considers permanent telehealth reform, I hope you will be willing to
                                      work with us to ensure that telehealth is available to all of those that wish to use
                                      it. Do you believe that there are some telehealth regulatory restrictions that Con-
                                      gress and HHS can work together to address in the near term?
                                         Answer. Telehealth has been invaluable during this pandemic to keep patients,
                                      their providers and their families safe, while maintaining access to critical health
                                      care. If I have the honor of being confirmed, I will be taking a careful look at tele-
                                      health along with my colleagues in the Centers for Medicare and Medicaid Services.
                                      I look forward to hearing more from you about what existing flexibilities you view
                                      as especially important.
                                        Question. The coronavirus pandemic has underscored the value of vaccines for in-
                                      fectious diseases, including those that originate abroad. We all recognize that
                                      COVID–19 will not be the last time we have to respond to an outbreak for which
                                      vaccinations are necessary in order to stem an emerging public health threat.
                                         Public policy should make vaccines as accessible as possible for our citizens. That
                                      is why current law requires that insurers provide coverage without cost sharing for
                                      all recommended vaccines, without limitation.
                                        Yet, inexplicably, current HHS regulations implementing the law limit mandatory
                                      coverage to so-called ‘‘routine’’ vaccines on the Immunization Schedules. As a result,
                                      many vaccines for infectious diseases are not covered without cost-sharing, including
                                      those for current vaccines such as rabies, anthrax, Japanese encephalitis, yellow
                                      fever, and cholera, and those vaccines in the pipeline for malaria, chikungunya, den-
                                      gue, and Zika.
                                        Last year, my colleagues and I worked on bipartisan legislation included in the
                                      CARES Act that ensures immediate coverage of COVID–19 vaccines with no cost-
                                      sharing. As I said then, Montanans and Americans across the country need access
                                      to vaccines, and financial barriers should not stand in the way during a national
                                      emergency or otherwise.
                                         Congress should not have had to be reactive. A forward-looking, uniform approach
                                      is needed to ensure that we are prepared to move quickly on vaccinations when the
                                      next pandemic occurs.
                                        If confirmed, will you commit to quickly bringing agency regulations in line with
                                      the statute requiring no cost-sharing for all CDC recommended vaccines to maxi-
                                      mize access to the best preventative measures against infectious diseases?
                                         Answer. As we have seen over the past year, vaccines are a critical part of the
                                      public health system working to keep Americans safe. We need to be prepared for
                                      any potential future outbreak, and I agree we cannot afford to be reactive on this.
                                      If confirmed, I would be happy to work with you to ensure we are ready for the
                                      next public health emergency.




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                                                             QUESTIONS SUBMITTED BY HON. TODD YOUNG
                                                                               MENTAL HEALTH

                                         Question. The coronavirus outbreak has created an unprecedented mental health
                                      challenge for our country. While we don’t yet know the full impact of the corona-
                                      virus in this area, we do know it has forced Americans to isolate from their loved
                                      ones and other support systems—causing a troubling spike in mental health and
                                      substance abuse problems. A Kaiser Family Foundation poll found that 45 percent
                                      of adults say the outbreak has affected their mental health, while a different study
                                      estimated that the pandemic could cause as many as 150,000 additional ‘‘deaths of
                                      despair’’ from suicide and overdose.
                                         In Indiana, preliminary data show that compared with 2019, last year had nearly
                                      a 50-percent increase in overdoses seen in emergency departments, with an 18-
                                      percent rise across the U.S. in just the first 4 months of the pandemic. In 2020,
                                      there was a 67-percent increase in the use of the opioid overdose reversal drug
                                      naloxone—further indicating a rise in overdoses.
                                         As HHS Deputy Secretary, how would you try to address this growing mental
                                      health crisis—both in the immediate aftermath of the public health emergency and
                                      in the long term?
                                         Given that mental health services cross many agencies, how will HHS coordinate
                                      efforts on this important issue? What programs or initiatives around mental health
                                      services would be your top priorities as Deputy Secretary?
                                         Answer. Unfortunately, the COVID–19 pandemic has dramatically impacted men-
                                      tal health and well-being for too many Americans. If confirmed, I am committed to
                                      working on this issue, including strong coordination among HHS agencies to support
                                      programs and initiatives across the continuum of prevention, intervention, treat-
                                      ment, and recovery support services as well as strengthening enforcement of this
                                      country’s mental health parity laws.

                                                                     SOCIAL DETERMINANTS OF HEALTH

                                        Question. Social determinants of health are the economic and social conditions in
                                      which people live, learn, work, and play—such as access to reliable transportation
                                      and stable housing. Addressing these factors can positively impact the health and
                                      well-being of the most vulnerable Americans.
                                        Do you have specific plans to address the social determinants of health?
                                        How would you work within HHS to better leverage existing programs and ad-
                                      dress the barriers to coordination between health and social services programs?
                                        Answer. We need to be smarter about tackling our biggest health-care challenges
                                      and understanding the many factors that affect outcomes is critical. Good data is
                                      critical in creating good policy, which can save money and lives, especially for our
                                      most vulnerable. If I have the honor of being confirmed, coordination across HHS
                                      programs would be instrumental to addressing social determinants of health. I look
                                      forward to working together with you on this important issue.

                                                                                   ----

                                                               QUESTIONS SUBMITTED BY HON. BEN SASSE
                                                                                 TELEHEALTH

                                         Question. While my colleagues have pointed out many of the ways COVID–19 has
                                      challenged our health-care system and exposed existing inequities, one bright spot
                                      in the pandemic has been increased access to telehealth services as a way for pa-
                                      tients to maintain their health from the safety of their homes. This has been par-
                                      ticularly important for States like Nebraska with large areas of rural population.
                                         We know that CMS has allowed expanded use of audio-only services during the
                                      pandemic, but how is CMS working to ensure that those without broadband access
                                      can utilize appropriate telehealth services in a post-pandemic world?
                                         Where do you stand on audio-only telehealth coverage? What about on payment
                                      parity between in-person and virtual services?
                                         How will you approach geographic restrictions, both in patient location and pro-
                                      vider licensure?




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                                        If confirmed, how do you plan to evaluate the use of telehealth over the last year
                                      and the places where it should—and potentially should not—be expanded beyond
                                      the end of the national emergency period?
                                         Answer. Telehealth is an important tool to improve health equity and access to
                                      health care. Health care should be accessible, no matter where you live. If con-
                                      firmed, I would look forward to working with you and my colleagues at the Centers
                                      for Medicare and Medicaid Services on this issue.
                                         Question. Individuals with chronic disease place an immense strain on our health-
                                      care system and account for a huge percentage of the overall costs to taxpayers. I
                                      think you would agree that early identification and treatment is crucial not only
                                      among those with chronic diseases but in ourhealth systems in general. Remote pa-
                                      tient monitoring (RPM) can be beneficial in managing both acute and chronic condi-
                                      tions and identifying deteriorations in health as early as possible to allow for the
                                      best level of care. Issues with reimbursement continue to constrain Medicare recipi-
                                      ents’ access to this level of monitoring.
                                        Do you see value in increased access to remote patient monitoring and what are
                                      your views on the co-pay requirement for these services?
                                         Answer. 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 bene-
                                      ficiaries who may benefit from these and other virtual services that allow their phy-
                                      sicians to help manage and treat their health conditions outside of regular office vis-
                                      its.
                                                                       MOST-FAVORED NATION MODEL

                                        Question. I have concerns with the Most-Favored Nation Model rulemaking, both
                                      with the policy of tying Medicare reimbursements to the prices foreign countries pay
                                      and with the creation of the expansive rule through the Center for Medicare and
                                      Medicaid Innovation (CMMI) under the guise of being a pilot program.
                                         If confirmed, how will you approach this policy? Do you support tying the prices
                                      of American drugs to foreign prices?
                                        Will you commit to ensuring that CMMI is used as intended rather than as a con-
                                      gressional workaround?
                                        Answer. We can all agree that bringing down the cost of prescription drugs needs
                                      to be a top priority. If confirmed, I will work to coordinate efforts across the Depart-
                                      ment to make sure we make progress toward this goal, and I look forward to work-
                                      ing with Congress on ideas that will result in lower costs for American patients and
                                      families.
                                                                               COVERAGE OPTIONS

                                        Question. As you have noted in the past, deductibles and premiums are often too
                                      high in the individual market for people who don’t receive subsidies. This has been
                                      particularly true in Nebraska, where for years we had one provider on the market
                                      and where even today the cheapest plan available on the individual market has a
                                      premium of $1,700 per month for a family of four.
                                        We have too often ignored the fact that States like Nebraska actually lost health-
                                      care options as a result of the ACA. My State benefited tremendously from the pre-
                                      vious administration’s rules expanding Associations Health Plans and Short-Term
                                      Limited Duration Plans, and I’m concerned about the rules establishing these plans
                                      potentially being rescinded due to politics rather than actual data on their effective-
                                      ness or service coverage. These plans are very popular in my State and often cost
                                      less than half as much as ACA plans while providing more personalized coverage.
                                      Having fewer options in this case actually increases the number of uninsured.
                                         In addition to your support for expanding subsidies in the individual market,
                                      would you also support continued access to more affordable options, such as Associa-
                                      tion Health Plans, Short-Term Limited Duration Plans, and Health Sharing Min-
                                      istries?
                                        If not, what data can you point to in recent years to say these plans haven’t prov-
                                      en to be popular and affordable options while still protecting those with pre-existing
                                      conditions?




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                                         Can you point to any actual evidence that these plans destabilized the market?
                                         Will you commit to working with Congress and other agencies to preserve these
                                      plan options for the millions of Americans who have enrolled?
                                         Answer. Making sure that all Americans have access to quality, affordable health
                                      care is one of the Biden administration’s top priorities. If confirmed, I will examine
                                      rules and other policies to ensure all Americans can access the care that they need.
                                         Question. Another popular and successful product in my State are Medicare Cost
                                      Plans, which offer a unique product in supplemental Medicare. These plans are par-
                                      ticularly popular in Western and rural Nebraska, where beneficiaries typically only
                                      have a fee-for-service product available to them.
                                         Do you believe the rules prohibiting competition between Medicare Advantage and
                                      Medicare Cost Plans make sense in today’s market, and does less competition ben-
                                      efit patients?
                                         Answer. Medicare Advantage and Medicare Cost Plans have an important role in
                                      giving people access to care. If confirmed, I would be happy to work with you on
                                      the unique needs and coverage options available to Nebraskans.
                                         Question. The previous administration worked on a rule to allow Direct Primary
                                      Care and Health Sharing Ministry expenses to be eligible expenses for use of health
                                      savings accounts under section 213 of the tax code. I believe strongly that Ameri-
                                      cans should be allowed to spend their health savings accounts on these services, and
                                      that more personalized choice in health markets leads to greater outcomes and high-
                                      er quality care.
                                         Would you commit to working with me to explore this policy change and others
                                      like it that expand access to these care and coverage options?
                                         Answer. Making sure that all Americans have access to quality, affordable health
                                      care is one of the Biden administration’s top priorities. As health-care costs have
                                      continued to rise, more burden has been shifted to consumers in the form of greater
                                      cost sharing. We must work to reduce barriers to access, including excessive cost
                                      sharing.
                                                                        TITLE X, CONSCIENCE RULES

                                         Question. The Department recently announced that it will replace the previous
                                      administration’s Protect Life rule, which upheld the long-time separation between
                                      abortion and health services by calling for title X grant recipients to ensure that
                                      abortion services were not co-located with federally funded services. This policy has
                                      been affirmed previously by the Supreme Court, and I believe it protects the integ-
                                      rity of the title X program.
                                         If confirmed, how do you plan to amend this rule moving forward?
                                         While it will ultimately be a decision made by Congress, will you commit to sup-
                                      porting continued inclusion of the Hyde amendment in future appropriations pack-
                                      ages, and if not, what is your justification for failing to protect the amendment,
                                      which has been the law of the land since 1976 and is supported by a majority of
                                      Americans?
                                         Will you commit to not reimpose the contraception mandate on religious min-
                                      istries like Little Sisters of the Poor?
                                         Will you commit to ensuring that medical professionals are not forced to perform
                                      procedures, like abortion, that go against their religious convictions?
                                         Answer. I understand that there are different, deeply held views on this issue.
                                      During my time in the Obama administration, I followed the law. If confirmed as
                                      Deputy Secretary, I will continue to follow the law.
                                                                                   ----
                                                            QUESTIONS SUBMITTED BY HON. JOHN BARRASSO
                                        Question. As a doctor, I strongly support increasing access to mental health serv-
                                      ices, especially in rural communities. Senator Stabenow and I have previously intro-
                                      duced legislation for many years that would allow mental health counselors and
                                      marriage and family therapists to receive reimbursement from Medicare.
                                        Can you discuss how the Department of Health and Human Services can improve
                                      access for mental health services, especially for those on Medicare?




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                                         In particular, can you comment on the merits of allowing licensed professional
                                      counselors and marriage and family therapists to receive reimbursements directly
                                      from Medicare?
                                         Answer. The COVID pandemic is taking a toll on Americans in so many ways,
                                      including their mental health. However, this Nation’s mental health crisis did not
                                      begin and will not end with the pandemic. We have to address this challenge from
                                      every angle, including by bolstering our mental health workforce. Mental health
                                      counselors and marriage and family therapists have an important role to play in our
                                      health-care system. If confirmed, I will work with you and other members of Con-
                                      gress to better integrate mental health care into our health-care system.
                                         Question. Rural communities are facing significant challenges, especially during
                                      the COVID–19 pandemic.
                                         Can you please discuss your priorities for improving health in rural America?
                                         Answer. I recognize that rural areas have unique needs and challenges. I’ve seen
                                      how rural areas can vary both among different States and also within a State. Rural
                                      areas in Wyoming can face different challenges than rural areas in Virginia or Geor-
                                      gia.
                                         The COVID–19 pandemic has further exposed weaknesses in our health-care sys-
                                      tem for both providers and patients in rural parts of the country. Rural hospitals
                                      and pharmacies are often the backbones of their communities, providing both nec-
                                      essary health care and employment. We should look at ways to bolster the rural
                                      health workforce, better utilize telehealth, and make sure these communities have
                                      the support they need. If confirmed, I look forward to working with you to ensure
                                      that rural communities are not left behind during the pandemic and beyond.
                                         Question. One of the most common challenges facing rural communities is recruit-
                                      ing enough health-care providers. These include doctors, but also nurse practi-
                                      tioners, physician assistants, nurses, and mental health providers, just to name a
                                      few.
                                         What are your general feelings on Federal health-care workforce policy?
                                         Answer. It is critically important to make sure we have enough providers to serve
                                      beneficiaries throughout the United States, including those in rural areas. This
                                      issue is becoming more acute as our population ages and doctors and other pro-
                                      viders retire. If confirmed, I look forward to working with you and other members
                                      of Congress to find creative ways to bolster the health-care workforce.
                                         Question. As you know, Medicare is the single largest funder of graduate medical
                                      education. Several years ago George Washington University released a study which
                                      found New York State received 20 percent of all Medicare’s graduate medical edu-
                                      cation (GME) funding while 29 States, including places struggling with a severe
                                      shortage of physicians, got less than 1 percent.
                                         Do you believe major reforms to Federal GME funding policy are needed?
                                         Do you believe the current funding formulas exacerbate health-care disparities in
                                      underserved communities?
                                         Answer. I believe it’s important to make sure we have enough providers, particu-
                                      larly as our population ages and doctors and other providers retire. I want to thank
                                      you for your work to add 1,000 new Medicare graduate medical education slots at
                                      the end of last year—the first increase to the program in nearly 25 years. I under-
                                      stand that Congress has prioritized these GME slots for teaching hospitals in under-
                                      served communities and other shortage areas, including rural areas. Prioritizing
                                      these communities for GME slots may help with provider shortages as doctors tend
                                      to want to stay where they trained. If confirmed, I want to work with you to make
                                      sure we have a robust health-care workforce across the country.
                                         Question. It is vital for the United States to learn from the COVID–19 pandemic
                                      and ensure we are better prepared for future public health emergencies. In par-
                                      ticular, I am interested in addressing the supply chain for personal protective equip-
                                      ment (PPE).
                                         How do you anticipate HHS partnering with the private sector supply chain to
                                      ensure that the country is ready for the next public health emergency?
                                         Answer. The global pandemic has highlighted the vulnerabilities of the global sup-
                                      ply chain for many products. In order to continue responding to the COVID–19 pan-
                                      demic and better prepare the Federal Government to respond to any future public




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                                      health emergencies, it is critical that HHS work to improve and expand domestic
                                      supply chain capabilities. If confirmed, I’m committed to working on this urgent
                                      matter.

                                                                                   ----
                                                              PREPARED STATEMENT OF HON. RON WYDEN,
                                                                   A U.S. SENATOR FROM OREGON

                                         The Finance Committee meets this morning to discuss two key health-care nomi-
                                      nations. Chiquita Brooks-LaSure is nominated to serve as Administrator for the
                                      Centers for Medicare and Medicaid Services, and Andrea Palm is nominated to
                                      serve as Deputy Secretary of the Department of Health and Human Services.
                                         Ms. Brooks-LaSure has served at OMB, on staff at the Ways and Means Com-
                                      mittee, at HHS, and in the private sector. She helped craft policies bringing down
                                      costs for seniors on Medicare. She helped to develop and pass key portions of the
                                      Affordable Care Act. At HHS she helped implement the law. She also worked hard
                                      to make sure that middle-class Americans shopping for private health insurance
                                      would get a fair shake thanks to strong consumer protections.
                                         The Trump administration later undermined a lot of those protections, which has
                                      created a lot of new challenges for this committee and the Biden administration to
                                      address.
                                         Ms. Brooks-LaSure is also well-versed in Medicaid policy. She’s worked closely
                                      with everybody involved in Medicaid—the Federal Government, States, and private
                                      organizations—to try to expand coverage, improve care, and help people get ahead.
                                         Continuing on the theme of impeccable qualifications and experience, Andrea
                                      Palm is a proven health-care agency leader who knows exactly what it takes to run
                                      HHS smoothly. She previously served as the Department’s Chief of Staff and senior
                                      counselor to the Secretary during the Obama administration. More recently, she
                                      served as Secretary-designee of the Wisconsin Department of Health Services, a
                                      $12-billion agency with 6,100 employees. She’s been the point person when it comes
                                      to the COVID response in the State of Wisconsin. She’s also led efforts to expand
                                      insurance coverage, improve mental health care, and reduce hunger.
                                         Bottom line, these are both highly qualified nominees who will be ready to go on
                                      Day 1 after they’re confirmed by the Senate. There’s a lot of work to be done at
                                      HHS in the months and years ahead, beginning with continuing the fight against
                                      COVID–19. Vaccinations are way up, but cases and deaths are still awfully high.
                                      There’s a long way to go in this pandemic.
                                         This committee’s also going to keep up its work on other health challenges facing
                                      the American people. For example, I’ve said that every time we discuss our Federal
                                      health programs, we’re going to talk about the transformation of Medicare. Medicare
                                      used to be an acute care program—broken ankles and bouts of the flu. These days
                                      it’s a chronic care program—cancer, Alzheimer’s, diabetes. This committee led the
                                      passage of the CHRONIC Care Act in 2017. The Trump administration slow-walked
                                      its implementation. I’m going to work with these nominees to turn that around.
                                         Second, in the American Rescue Plan the Congress made a big down payment for
                                      mental health services based on the CAHOOTS program. It’s all about using health
                                      care, rather than law enforcement, to help people experiencing a mental health cri-
                                      sis. It’s been a big success in Oregon, and I want to expand it even further.
                                         This committee is also putting a special focus on the issue of inequality in our
                                      Federal programs. Especially during the pandemic, the American people have seen
                                      the results of health-care disparities up close. Blacks, Latinos, and Native Ameri-
                                      cans have suffered and died from COVID–19 at much higher rates. However, it’s
                                      not just about COVID–19. It’s also about maternal health, because women today are
                                      more likely to die in childbirth than their mothers were a generation ago.
                                         I also want to work closely with HHS on the issue of lowering prescription drug
                                      costs. That’s because Americans get socked every time they walk up to the phar-
                                      macy window, and it’s long past time for Congress to act.
                                         Finally, this country needs a revolution when it comes to access to mental health
                                      care. The law says that mental health care and physical health care are equally im-
                                      portant, but in practice, mental health is often given short shrift. This is a major
                                      priority for members of this committee, so we’ll continue working closely with these
                                      nominees on this issue—and all these issues I’ve raised—when they’re confirmed.




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                                                                                       138
                                        I want to thank Ms. Brooks-LaSure and Ms. Palm for their willingness to serve
                                      in these extraordinarily challenging and vital roles. I look forward to the discussion
                                      today.


                                                                       NATIONAL ASSOCIATION OF ACOS
                                                                        601 13th Street, NW, Suite 900 South
                                                                               Washington, DC 20005
                                                                                   202–640–1985
                                                                                  info@naacos.com
                                                                             https://www.naacos.com/

                                      The National Association of ACOs (NAACOS) appreciates the opportunity to express
                                      our views on the nomination of Andrea Joan Palm to be Deputy Secretary of the
                                      Department of Health and Human Services (HHS) and Chiquita Brooks-LaSure to
                                      be Administrator of the Centers for Medicare and Medicaid Services (CMS). We
                                      strongly support the nominations of Ms. Palm and Ms. Brooks-LaSure and are hope-
                                      ful that they and the Committee will consider the following issues in their work
                                      ahead.
                                      NAACOS represents more than 12 million beneficiary lives through hundreds of or-
                                      ganizations participating in population health-focused payment and delivery models
                                      in Medicare, Medicaid, and commercial insurance. Models include the Medicare
                                      Shared Savings Program (MSSP), the Next Generation Model, the Direct Con-
                                      tracting Model, and alternative payment models supported by a myriad of commer-
                                      cial health plans and Medicare Advantage. NAACOS is a member-led and member-
                                      owned nonprofit organization that works to improve quality of care, outcomes, and
                                      healthcare cost efficiency.
                                      NAACOS looks forward to working collaboratively with the Committee and today’s
                                      nominees on these topics. Mostly notably, we hope these appointments will bolster
                                      the shift to value following recent years of policies that have hampered that critical
                                      transition. The transition to value should not be taken for granted. While much
                                      progress has been made in the past decade, this transformation is threatened. For
                                      example, according to new data 1 released by CMS, the number of participants in
                                      the largest and most successful value-based payment model, the MSSP, reached its
                                      lowest level since the Trump administration took office 4 years ago. As shown below,
                                      to start 2021, 477 ACOs are participating in the MSSP, down from a high of 561
                                      in 2018 and the lowest since 480 participated in 2017, the Trump administration’s
                                      first year in office.



                                                         Total Shared Savings Program ACOs




                                               2012      2013   201~     2015     2016      2017       2018    2019   2020        2021


                                      In contrast to the diminishing number of ACOs, the MSSP continued to produce
                                      greater savings every year and saw its best year yet in 2019,2 the most recent year
                                      for which data is available. Serving 11.2 million seniors in 2019, the MSSP saved

                                           1 https://www.cms.gov/files/document/2021-shared-savings-program-fast-facts.pdf.
                                           2 https://www.naacos.com/press-release--py-2019-results.




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                                                                                          139
                                      Medicare $2.6 billion and $1.2 billion after accounting for shared savings bonuses
                                      and collecting shared loss payments. Gross savings are shown below.




                                                                     Gross Savings
                                                           from the Shared Savings Program

                                             ~
                                             ~

                                             .i
                                              ..
                                              ::,

                                             "'
                                             ~ ---------;---...:........:..r---+--F:::.:::i--
                                             ~ $234  $292        $652

                                                    2013        2014       2015       2016       2017       2018      2019      TOTAL



                                      The Next Generation ACO Model, the premier accountable care model ran out of
                                      the CMS Innovation Center that emphasizes high risk and high reward, has also
                                      demonstrated great results. Serving 1.2 million patients in 2019, the model saved
                                      $559 million compared to the CMS-generated benchmarks and netted $204 million
                                      to the Medicare Trust Fund after accounting for shared savings, shared losses, and
                                      discounts paid to CMS. NAACOS urges CMS to extend the Next Gen model through
                                      2022, giving time to install it as a permanent option for ACOs, either as a stand-
                                      alone track or option within MSSP. The model is scheduled to sunset at the end
                                      of 2021. The above results should speak for themselves and substantiate perman-
                                      entizing.
                                      Given the success of the ACO program and need to strongly support the transition
                                      to value-based care and payment, we request HHS re-examine the balance of risk
                                      and reward for ACOs to bolster ACO growth and therefore savings to Medicare and
                                      to support high quality, coordinated patient care. Among those changes, we request
                                      that HHS and CMS reverse certain policies from a 2018 MSSP overhaul, which
                                      CMS called the ACO ‘‘Pathways to Success.’’ That overhaul included some damaging
                                      provisions such as a cut to the share of savings most ACOs are eligible to keep and
                                      a push for ACOs to assume risk too quickly. These policies have chilled ACO growth
                                      and should be changed.
                                      NAACOS also recommends that HHS focus the value transition on providers, keep-
                                      ing them at the center of payment models instead of implementing programs and
                                      policies to attract new players into traditional Medicare. As a telling example of
                                      CMS’s recent approach, in 2018 the agency released a model initially titled ‘‘Direct
                                      Provider Contracting,’’ only to later drop the word ‘‘Provider.’’ That name change
                                      went along with an emphasis on giving favorable treatment to entice new partici-
                                      pants, such as payers, to the model at the expense of those who have been on the
                                      frontlines of the value transition for the past decade.
                                      To support the ACO movement and recalibrate the value transition to center on and
                                      support healthcare providers, NAACOS recommends the following:
                                           • Set a national goal to have a majority of traditional Medicare beneficiaries in
                                             an ACO by 2025.
                                           • Deprioritize the rush to risk and build a population health infrastructure.
                                           • Address overlap of competing payment models to prioritize total cost of care
                                             models.
                                           • Strengthen incentives to attract new ACOs and retain existing ones.
                                           • Provide meaningful funding to build infrastructure necessary to spur innovation
                                             and value through expanded advanced payments and grants.
                                      To make progress on the broader goals listed above, NAACOS recommends enacting
                                      the following specific policy change this year:




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                                                                                       140
                                           • Adapt ACO and alternative payment model methodologies to account for
                                             COVID–19 anomalies.
                                           • Halt implementation of the Geographic Option of the Direct Contracting Model
                                             and improve aspects of the Professional and Global Options to benefit legacy
                                             ACOs/providers.
                                           • Improve the MSSP by increasing ACO shared savings rates, fixing key
                                             benchmarking and risk adjustment issues, allowing more time before requiring
                                             risk, and revisiting recently finalized quality policies.
                                           • Make the Next Generation ACO Model permanent.
                                           • Provide more timely and complete data to ACOs.
                                      Ultimately, President Biden’s administration inherits fewer ACOs than the Obama
                                      administration left at the start of 2017, which is a trend NAACOS hopes will be
                                      reversed under your leadership at HHS. We appreciate the work of the Committee
                                      on these topics and look forward to working with the nominees.

                                                                                     ----
                                                                      NATIONAL HEALTH LAW PROGRAM
                                                                            1444 I Street, NW, Suite 1105
                                                                               Washington, DC 20005
                                                                                   (202) 289–7661
                                                                               https://healthlaw.org/

                                      April 15, 2021
                                      The Honorable Ron Wyden                              The Honorable Patty Murray
                                      Chairman                                             Chair
                                      U.S. Senate                                          U.S. Senate
                                      Committee on Finance                                 Committee on Health, Education, Labor,
                                                                                             and Pensions
                                      Washington, DC 20510                                 Washington DC 20510
                                      The Honorable Mike Crapo                             The Honorable Richard Burr
                                      Ranking Member                                       Ranking Member
                                      U.S. Senate                                          U.S. Senate
                                      Committee on Finance                                 Committee on Health, Education Labor,
                                                                                             and Pensions
                                      Washington, DC 20510                                 Washington, DC 20510
                                      Dear Chairman Wyden, Ranking Member Crapo, Chair Murray, and Ranking Mem-
                                      ber Burr,
                                      On behalf of the National Health Law Program, we write to urge you to support
                                      Chiquita Brooks-LaSure’s confirmation as the next Administrator of the Department
                                      of Health and Human Services’ Centers for Medicare and Medicaid Services (CMS).
                                      As a long-time thought leader and expert on access to health care for low-income
                                      people, particularly those most underserved by our health-care system, Brooks-
                                      LaSure has the expertise, experience, and dedication to advancing access to quality
                                      health care and health equity needed to guide CMS.
                                      CMS provides vital health coverage to more than 100 million people through Med-
                                      icaid, CHIP, Medicare, and the health insurance marketplaces. With over two dec-
                                      ades of Medicaid and health-care reform leadership and expertise under her belt,
                                      as well as a demonstrated commitment to advancing health equity, Brooks-LaSure
                                      is an exceptional candidate to lead CMS.
                                      Before her most recent work as a Managing Director at Manatt, Brooks-LaSure
                                      served in key leadership roles advancing implementation of the Patient Protection
                                      and Affordable Care Act (ACA) within the Obama Administration. She served as Di-
                                      rector of Coverage Policy in the White Home Office of Health Care Reform, and later
                                      as Deputy Director for Policy at CMS’ Center for Consumer Information and Insur-
                                      ance Oversight. Before that, she served as staff on the House Ways and Means
                                      Committee, where she contributed to the ACA’s passage.
                                      Throughout her career, Brooks-LaSure has emphasized Medicaid and the ACA mar-
                                      ketplaces’ crucial roles in alleviating racial inequities in health outcomes. She has
                                      called out the role of the Trump administration’s Medicaid work requirements and
                                      2019 public charge rule in perpetuating health inequities, particularly for people of
                                      color. She has highlighted the importance of more robust data collection to better
                                      serve underserved populations and alleviate health inequities. Brooks-LaSure has
                                      stressed the importance of centering community voices in health policy development




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                                                                                      141
                                      and priority-setting—an approach that is essential to fostering a healthier and more
                                      equitable country for all.
                                      Brooks-LaSure has paid particular attention to our country’s unconscionable Black
                                      maternal health crisis. She has underscored the importance of extending Medicaid
                                      and CHIP to 12 months postpartum—a reform now possible through the American
                                      Rescue Plan Act’s new state plan amendment options. She has addressed the impor-
                                      tance of efforts to expand access to doula care. Her testimony at a 2019 House Ways
                                      and Means Hearing on pathways to universal health coverage specifically high-
                                      lighted racial injustices in maternal mortality.
                                      The challenges facing this nation are multifold, both acute and long-simmering. The
                                      pandemic has exposed flagrant flaws in our health-care system and painfully re-
                                      vealed the United States’ entrenched health inequities. There is much to be done
                                      and undone to build a more robust and equitable health-care system. Our country
                                      desperately needs a CMS administrator who will center urgent health equity chal-
                                      lenges and prioritize equitable solutions. We look forward to working with Brooks
                                      LaSure and the team at CMS to advance those solutions. We urge the Senate to
                                      confirm her nomination swiftly and resolutely.
                                      If you have any questions, please contact Madeline Morcelle at morcelle@healthlaw.
                                      org.
                                      Sincerely,
                                      Elizabeth Taylor                            Mara Youdelman
                                      Executive Director                          Managing Attorney, Washington, DC
                                                                                     Office



                                                                                      Æ




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