Key Insights from GAO's Oversight of the Federal Public Health Response (GAO-21-396T)

Summary

GAO testimony, GAO-21-396T, before the House Committee on Homeland Security on February 24, 2021, the statement of A. Nicole Clowers, Managing Director, Health Care Team, on key insights from GAO's oversight of the federal public health response to COVID-19. It notes that as of February 17, 2021 the U.S. had about 27 million cumulative reported cases and more than 486,000 reported deaths, according to the Centers for Disease Control and Prevention. GAO states that more than a year after COVID-19 was declared a public health emergency, the pandemic continues to lay bare the fragmented public health sector, the fragility of the medical supply chain and longstanding disparities in health care access, treatment and outcomes.

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United States Government Accountability Office
Testimony
Before the Committee on Homeland
Security, House of Representatives

COVID-19
For Release on Delivery
Expected at 9:30 a.m. ET
Wednesday, February 24, 2021

Key Insights from GAO’s
Oversight of the Federal
Public Health Response
Statement of A. Nicole Clowers, Managing Director,
Health Care Team

GAO-21-396T
February 24, 2021

COVID-19
Key Insights from GAO’s Oversight of the Federal
Public Health Response
Highlights of GAO-21-396T, a testimony
before the Committee on Homeland Security,
House of Representatives

Why GAO Did This Study What GAO Found
As of February 17, 2021, the U.S. had More than a year after the U.S. declared COVID-19 a public health emergency,
about 27 million cumulative reported the pandemic continues to result in catastrophic loss of life and substantial
cases of COVID-19 and more than damage to the economy. It also continues to lay bare the fragmented nature of
486,000 reported deaths, according to our public health sector, the fragility of the nation’s medical supply chain, and
the Centers for Disease Control and longstanding disparities in health care access, treatment, and outcomes.
Prevention. The country also continues
to experience serious economic GAO has made 44 recommendations to federal agencies. Of these
repercussions. recommendations, 16 relate to the following public health topics:
Five relief laws, including the CARES COVID-19 Testing. GAO has made two recommendations to date to improve the
Act, have appropriated $3.1 trillion to federal government’s efforts in diagnostic testing for COVID-19, critical to
address the public health and controlling the spread of the virus. In January 2021, GAO recommended that the
economic threats posed by COVID-19. Department of Health and Human Services (HHS) develop and make publicly
The CARES Act also includes a available a comprehensive national COVID-19 testing strategy.
provision for GAO to report on its
ongoing monitoring and oversight Vaccines and Therapeutics. GAO has made two recommendations to improve
efforts related to COVID-19. transparency, communication, and coordination around the government’s efforts
to develop, manufacture, and distribute vaccines and therapeutics to prevent and
This testimony summarizes GAO’s treat COVID-19. For example, in September 2020, GAO recommended that HHS
insights from its oversight of the federal establish a time frame for a national vaccine distribution and administration plan
government’s pandemic response in a
that follows best practices, with federal and nonfederal coordination.
series of comprehensive reports issued
from June 2020 through January 2021. Medical Supply Chain. GAO has made seven recommendations for the federal
In particular, the statement focuses on government to respond to vulnerabilities highlighted by the pandemic in the
the public health response, including nation’s medical supply chain, including limitations in personal protective
testing, vaccines and therapeutics, equipment and other supplies necessary to treat individuals with COVID-19. In
medical supply chain, health January 2021, GAO recommended that HHS establish a process for regularly
disparities, and health data. engaging with Congress and nonfederal stakeholders as the agency refines and
GAO reviewed data, documents, and implements its supply chain strategy for pandemic preparedness, to include the
guidance from federal agencies about role of the Strategic National Stockpile.
their activities and interviewed federal
COVID-19 Health Disparities. GAO has made three recommendations to
and state officials and stakeholders for
the series of reports on which this
improve COVID-19 data by race and ethnicity, as available data show
testimony is based. See communities of color bear a disproportionate burden of COVID-19 positive tests,
https://www.gao.gov/coronavirus/. cases, hospitalizations, and deaths. In September 2020, GAO recommended that
the Centers for Disease Control and Prevention involve key stakeholders to help
What GAO Recommends ensure the complete and consistent collection of demographic data.
GAO has made 44 recommendations COVID-19 Data. GAO has made two recommendations to improve the collection
for agencies and four matters for of data needed to respond to COVID-19 and prepare for future pandemics. GAO
congressional consideration in its recommended in January 2021 that HHS establish an expert committee to help
comprehensive series of bimonthly systematically define and ensure the collection of standardized data across the
reports on the federal response to relevant federal agencies and related stakeholders; the absence of such data
COVID-19 over the last year. GAO will hinders the ability of the government to respond to COVID-19, communicate the
issue its next report in this series in status of the pandemic with citizens, or prepare for future pandemics.
March 2021.
Although the responsible agencies generally agreed with the majority of the 16
recommendations, only one has been fully implemented. GAO maintains that
View GAO-21-396T. For more information,
contact A. Nicole Clowers, (202) 512-7114 or implementing these recommendations will improve the federal government’s
clowersa@gao.gov. public health response and ability to recover as a nation.

United States Government Accountability Office
Letter Letter

Chairman Thompson, Ranking Member Katko, and Members of the
Committee:

Thank you for the opportunity to discuss the federal government’s
ongoing response to Coronavirus Disease 2019 (COVID-19). The
pandemic has resulted in catastrophic loss of life and substantial damage
to the global economy, and to the stability and security of our nation. As
of February 17, 2021, the U.S. had more than 27 million reported cases
and 486,000 reported deaths, according to the Centers for Disease
Control and Prevention (CDC).

The country also continues to experience serious economic
repercussions. In January 2021, there were more than 10.1 million
unemployed individuals, compared to nearly 5.8 million individuals in
January 2020.

Over the past 2 weeks, case counts and deaths have slowed since
peaking in January 2021. But public health officials warn that we should
not become complacent in our efforts, as new variants of virus appear
across the country. Until the country better contains the spread of the
virus, the pandemic will continue to lay bare the fragmented nature of our
public health sector, the fragility of our medical supply chain, and
longstanding disparities in health care access, treatment, and outcomes,
as well as impeding a more robust economic recovery.

In response to this ongoing public health emergency, and the resulting
economic challenges, Congress and the administration have taken a
series of actions to protect the health and well-being of Americans.
Notably, in March 2020, Congress passed, and the President signed into
law, the CARES Act, which provided over $2 trillion in emergency
assistance and health care response for individuals, families, and

Page 1 GAO-21-396T
businesses affected by COVID-19. 1 To date, the five enacted COVID-19
relief laws, including the CARES Act, have appropriated $3.1 trillion.

The CARES Act includes a provision for us to conduct monitoring and
oversight of the federal government’s efforts to prepare for, respond to,
and recover from the COVID-19 pandemic, including issuance of bi-
monthly reports to Congress. 2 We are to report on, among other things,
the effect of the pandemic on public health and the economy. To date, our
work in response to this provision includes five comprehensive issued
reports from June 2020 through January 2021; we will issue our next
government-wide report on the federal response to the COVID-19
pandemic at the end of March.

In our five reports we have made 44 recommendations to federal
agencies, and raised four matters for congressional consideration to
improve the federal government’s response efforts. 3 Our
recommendations are tailored to specific federal programs and initiatives,
and, if implemented, will strengthen the efficiency, effectiveness, and
accountability of these federal efforts. We urge the new Congress and
administration to consider these recommendations as well as the
principles of an effective federal response that we have previously
identified.

My comments today will summarize the key findings and
recommendations from our oversight of the federal government’s
continued efforts to respond to and recover from the COVID-19
pandemic. I will focus my comments on our findings related to the public
health response, including COVID-19 testing, vaccines and therapeutics,

1Pub. L. No. 116-136, 134 Stat. 281 (2020). As of January 1, 2021, four other relief laws
were also enacted in response to the COVID-19 pandemic: the Consolidated
Appropriations Act, 2021, Pub. L. No. 116-260, 134 Stat. 1182 (2020); Paycheck
Protection Program and Health Care Enhancement Act, Pub. L. No. 116-139, 134 Stat.
620 (2020); Families First Coronavirus Response Act, Pub. L. No. 116-127, 134 Stat. 178
(2020); and the Coronavirus Preparedness and Response Supplemental Appropriations
Act, 2020, Pub. L. No. 116-123, 134 Stat. 146. We refer to these five laws, each of which
was enacted as of January 1, 2021, and provides appropriations for the COVID-19
response, as “COVID-19 relief laws,” and the funding appropriated by these laws as
“COVID-19 relief funds.” In January 2020, the novel coronavirus was declared a public
health emergency.
2Pub. L. No. 116-136, § 19010, 134 Stat. at 579-81.

3See https://www.gao.gov/coronavirus/ for our comprehensive reports and other COVID-
19 related reports.

Page 2 GAO-21-396T
the medical supply chain, COVID-19 health disparities, and COVID-19
health data.

We conducted the work on which this statement is based, which was
completed on January 15, 2021, with updates to federal agency data, as
available, in accordance with generally accepted government auditing
standards. 4 Those standards require that we plan and perform the audit
to obtain sufficient, appropriate evidence to provide a reasonable basis
for our findings and conclusions based on our audit objectives. We
believe that the evidence obtained provides a reasonable basis for our
findings and conclusions based on our audit objectives.

In February 2020, at the outset of the COVID-19 pandemic, we identified
Key Insights from key principles that are essential for an effective federal
GAO’s Oversight of response. 5 Specifically, based on our prior work examining responses to
large-scale catastrophic disasters or public health emergencies, we
the Federal emphasized the need for federal agencies to coordinate, establish, and
Response to COVID- define roles and responsibilities among those responding to the crisis,
and to provide clear, consistent communication. In June 2020, we
19 reinforced the importance of these key principles and also emphasized
the need to collect and analyze data to inform decision-making and future
preparedness; establish clear goals; establish mechanisms for
accountability and transparency to help ensure program integrity; and
address fraud risks. Incorporating these principles into ongoing or new
COVID-19-related programs and policies will improve the effectiveness of
the federal government’s response.

Of the 44 recommendations we have made to date, 16 fall into one of the
following public health areas: COVID-19 testing, vaccines and
therapeutics, medical supply chain, COVID-19 health disparities, and
COVID-19 health data.

COVID-19 Testing Diagnostic testing for COVID-19 is critical to controlling the spread of the
virus, according to CDC. We have made two recommendations to
improve the federal government’s COVID-19 testing efforts, as shown in

4We reviewed data, documents, and guidance from federal agencies about their activities
and interviewed federal and state officials and stakeholders for the series of reports on
which this testimony is based.
5A. Nicole Clowers, Managing Director of GAO’s Health Care team, Roundtable: Are We
Prepared? Protecting the U.S. from Global Pandemics, testimony before the Senate
Committee on Homeland Security and Governmental Affairs. 116th Cong., 2nd sess., Feb.
12, 2020.

Page 3 GAO-21-396T
table 1. Most recently, in January 2021, we found that the Department of
Health and Human Services (HHS) had not issued a comprehensive and
publicly available national testing strategy. For example, stakeholders
involved in the response efforts told us that they either were unaware of
the national strategy or did not have a clear understanding of it. Without a
comprehensive, publicly available national strategy, HHS is at risk of key
stakeholders and the public lacking crucial information to support an
informed and coordinated testing response.

In January 2021, we recommended that HHS develop and make
publicly available a comprehensive national COVID-19 testing
strategy that incorporates all six characteristics of an effective
national strategy. Such a strategy could build upon existing strategy
documents that HHS has produced for the public and Congress to allow
for a more coordinated pandemic testing approach. (See table 1.)

Table 1: GAO’s Recommendations Related to COVID-19 Testing

Recommendation Status
The Secretary of Health and Human Services (HHS) should Open. HHS partially concurred with our recommendation. HHS
develop and make publicly available a comprehensive agreed that the department should take steps to more directly
national COVID-19 testing strategy that incorporates all six incorporate some of the elements of an effective national strategy,
characteristics of an effective national strategy. Such a but expressed concern that producing such a strategy at this time
strategy could build upon existing strategy documents that could be overly burdensome on the federal, state, and local entities
HHS has produced for the public and Congress to allow for a that are responding to the pandemic, and that a plan would be
more coordinated pandemic testing approach (January 2021 outdated by the time it was finalized or potentially rendered obsolete
report). by the rate of technological advancement.
The Secretary of Health and Human Services should ensure Open. HHS concurred with our recommendation, noting that CDC
that the Director of the Centers for Disease Control and officials typically consult with scientific stakeholders when issuing
Prevention (CDC) clearly discloses the scientific rationale for guidance and that HHS will continue to evaluate its processes in this
any change to testing guidelines at the time the change is area.
made (November 2020 report).
Source GAO I GAO-21-396T

Vaccines and Multiple federal agencies support the development and manufacturing,
Therapeutics and now distribution, of vaccines and therapeutics to prevent and treat
COVID-19. Agencies involved in the federal partnership (formerly called
Operation Warp Speed) include the Department of Defense (DOD) and
HHS, including HHS’s Biomedical Advanced Research and Development
Authority (BARDA), Food and Drug Administration (FDA), CDC, and the
National Institutes of Health (NIH). DOD is supporting HHS in nationwide
distribution efforts of any licensed or authorized vaccine. As of February
18, 2021, two of the six Operation Warp Speed vaccine candidates had
been authorized by FDA for emergency use, and vaccine distribution and
vaccine administration began in December 2020. A third company

Page 4 GAO-21-396T
submitted a request for emergency use authorization for its vaccine to
FDA on February 4, 2021.

In addition, the Federal Emergency Management Agency (FEMA)
provides funding to states (including D.C.), tribes and territories, for
expenses related to COVID-19 vaccination. In accordance with a January
21, 2021, presidential memorandum, FEMA will reimburse states,
territorial, local, and tribal governments for costs associated with vaccine
distribution and administration through the Disaster Relief Fund, which
had a balance of more than $12.2 billion, as of February 7, 2021,
according to FEMA. 6 The agency has also deployed staff across the
nation to support vaccine centers with federal personnel and technical
assistance.

As shown in table 2, we have made two recommendations to improve the
government’s efforts related to vaccines and therapeutics. In particular, in
September 2020, we reported that clarity on the federal government’s
plans for distributing and administering vaccine, as well as timely, clear,
and consistent communication to stakeholders and the public about those
plans, is essential. In September 2020, we recommended that HHS,
with the support of DOD, establish a time frame for documenting
and sharing a national plan for distributing and administering
COVID-19 vaccines that, among other things, outlines an approach
for how efforts would be coordinated across federal agencies and
nonfederal entities.

In our January 2021 report, we noted that vaccine distribution and
administration had, as of January, fallen short of expectations. We
reiterated the importance of fully implementing our September 2020
recommendation. (See table 2.)

6White House, Memorandum to Extend Federal Support to Governors’ Use of the National
Guard to Respond to COVID-19 and to Increase Reimbursement and Other Assistance
Provided to States, (Washington, D.C.: Jan. 21, 2021), accessed on February 4, 2021,
https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/21/extend-federal-
support-to-governors-use-of-national-guard-to-respond-to-covid-19-and-to-increase-reimb
ursement-and-other-assistance-provided-to-states/. According to FEMA, as of February 7,
2021, it had provided more than $2.29 billion to 32 states, the District of Columbia, three
territories, and two tribes for expenses related to COVID-19 vaccination efforts.

Page 5 GAO-21-396T
Table 2: GAO’s Recommendations Related to COVID-19 Vaccines and Therapeutics

Recommendation Status
The Secretary of Health and Human Services should direct the Closed. FDA developed a process for working with drug sponsors
Commissioner of the Food and Drug Administration (FDA) to to disclose its scientific review documents for therapeutic EUAs
identify ways to uniformly disclose to the public the information and has released this information for the EUAs it has already
from FDA’s scientific review of safety and effectiveness data— issued. For vaccine EUAs, FDA is holding public Vaccines and
similar to the public disclosure of the summary safety and Related Biological Products Advisory Committee meetings, through
effectiveness data supporting the approval of new drugs and which FDA and sponsors are making information from scientific
biologics—when issuing emergency use authorizations (EUA) for reviews publicly available. The agency also released decision
therapeutics and vaccines, and, if necessary, seek the authority memos with detailed information about the agency’s review of
to publicly disclose such information (November 2020 report on safety and effectiveness data for the two vaccines authorized to
vaccine and therapeutics). date.
The Secretary of Health and Human Services, with support from Open. The Department of Health and Human Services (HHS)
the Secretary of Defense, should establish a time frame for neither agreed nor disagreed with our recommendation. In
documenting and sharing a national plan for distributing and November 2020, we reported that HHS and the Department of
administering a COVID-19 vaccine and, in developing such a Defense had released initial planning documents for the distribution
plan, ensure that it is consistent with best practices for project and administration of potential COVID-19 vaccines, but also
planning and scheduling and outlines an approach for how reported that stakeholders indicated that they would like to see
eﬀorts will be coordinated across federal agencies and additional information as planning continued.
nonfederal entities (September 2020 report).
Source GAO Analysis I GAO-21-396T

Medical Supply Chain The pandemic has highlighted vulnerabilities in the nation’s medical
supply chain, which includes personal protective equipment and other
supplies necessary to treat individuals with COVID-19. Ensuring the
availability of medical supplies to meet the continuing needs of state,
local, tribal, and territorial governments, as well as point-of-care
providers, such as nursing homes, has been a persistent challenge for
federal agencies. Continued supply chain constraints may also hamper
HHS’s goal of building a 90-day supply of certain key items in the
Strategic National Stockpile (SNS).

Multiple federal agencies have responsibility for coordinating and
managing the medical supply chain, and HHS and FEMA lead the federal
response through the Unified Coordination Group. 7 HHS is designated as
the lead agency to address the public health and medical portion of the
response and FEMA is designated as the lead agency for coordinating
the overall federal response. The agencies are responsible for supporting
and informing decisions made by the Unified Coordination Group

7The Unified Coordination Group (UCG) is the primary field entity for the federal response.
The group integrates diverse federal authorities and capabilities and coordinates federal
response and recovery operations. The UCG is jointly led by the Administrator of FEMA,
the Assistant Secretary for Preparedness and Response, and a representative of CDC.

Page 6 GAO-21-396T
regarding the allocation, distribution, and procurement of COVID-related
supplies (see fig. 1).

Figure 1: Key Federal Agencies Involved in Coordinating and Managing the Medical Supply Chain during the COVID-19
Pandemic

We have made seven recommendations to improve the federal
government’s efforts to address medical supply challenges highlighted by
the pandemic (see table 3.) In our January 2021 report, we focused on
the role of the SNS, which is an important piece of HHS’s strategy to
improve the medical supply chain to enhance pandemic response
capabilities and was being finalized during the course of our review.
However, the department has yet to develop a process for engaging
about the strategy with key nonfederal stakeholders that have a shared
role for providing supplies during a pandemic, such as state and territorial
governments and the private sector. Our work has noted the importance
of directly and continuously involving key stakeholders, including

Page 7 GAO-21-396T
Congress, in the development of successful agency reforms and in
helping to harness ideas, expertise, and resources.

In January 2021, we recommended that HHS establish a process for
regularly engaging with Congress and nonfederal stakeholders—
including state, local, tribal, and territorial governments and private
industry—as the agency refines and implements its supply chain
strategy for pandemic preparedness, to include the role of the SNS.

Table 3: GAO Recommendations Related to Medical Supply Chain Challenges

Recommendation Status
To improve the nation’s response to and preparedness for Open. HHS generally concurred with our recommendation, and
pandemics, the Assistant Secretary for Preparedness and added that improving the pandemic response capabilities of state,
Response should establish a process for regularly engaging with local, tribal, and territorial governments is a priority.
Congress and nonfederal stakeholders—including state, local,
tribal, and territorial governments and private industry—as the
Department of Health and Human Services (HHS) refines and
implements a supply chain strategy for pandemic preparedness,
to include the role of the Strategic National Stockpile (January
2021 report).
The Assistant Secretary for Preparedness and Response, in Open. HHS concurred with our recommendation and stated that it
coordination with the appropriate offices within HHS, should has taken steps to manually identify its other transaction
accurately report data in the federal procurement database agreements in its contract writing system to allow the public to
system and provide information that would allow the public to distinguish between spending on agreements and procurement
distinguish between spending on other transaction agreements contracts in the Federal Procurement Data System-Next
and procurement contracts (January 2021 report). Generation. HHS also plans to update its contract writing system.
The Commissioner of the Food and Drug Administration (FDA) Open. HHS neither agreed nor disagreed with our
should, as the agency makes changes to its collection of drug recommendation. In HHS’s response, FDA said that as the
manufacturing data, ensure the information obtained is complete agency continues efforts to enhance relevant authorities and close
and accessible to help it identify and mitigate supply chain data gaps, it will consider GAO’s recommendation.
vulnerabilities, including by working with manufacturers and other
federal agencies (e.g., the Departments of Defense and Veterans
Affairs), and, if necessary, seek authority to obtain complete and
accessible information (January 2021 report).
The Secretary of Health and Human Services, in coordination with Open. HHS disagreed with our recommendation at the time the
the Administrator of the Federal Emergency Management report was issued and noted, among other things, the work that
Agency(FEMA)—who head agencies leading the COVID-19 the department had done to manage the medical supply chain and
response through the Unified Coordination Group—should increase supply availability.
immediately document roles and responsibilities for supply chain
management functions transitioning to the Department of Health
and Human Services, including continued support from other
federal partners, to ensure sufficient resources exist to sustain
and make the necessary progress in stabilizing the supply chain,
and address emergent supply issues for the duration of the
COVID-19 pandemic (September 2020 report).

Page 8 GAO-21-396T
Recommendation Status
The Secretary of Health and Human Services in coordination with Open. HHS disagreed with our recommendation at the time the
the Administrator of FEMA—who head agencies leading the report was issued and noted, among other things, the work that
COVID-19 response through the Unified Coordination Group— the department had done to manage the medical supply chain and
should further develop and communicate to stakeholders plans increase supply availability.
outlining specific actions the federal government will take to help
mitigate remaining medical supply gaps necessary to respond to
the remainder of the pandemic, including through the use of
Defense Production Act authorities (September 2020 report).
The Secretary of Health and Human Services —who heads one of Open. HHS disagreed with our recommendation at the time the
the agencies leading the COVID-19 response through the Unified report was issued and noted, among other things, the work that
Coordination Group—consistent with the department’s roles and the department had done to manage the medical supply chain and
responsibilities, should work with relevant federal, state, territorial, increase supply availability.
and tribal stakeholders to devise interim solutions, such as
systems and guidance and dissemination of best practices, to
help states enhance their ability to track the status of supply
requests and plan for supply needs for the remainder of the
COVID-19 pandemic response (September 2020 report).
The Administrator of FEMA—who heads one of the agencies Open. The Department of Homeland Security, on behalf of FEMA,
leading the COVID-19 response through the Unified Coordination disagreed with our recommendation at the time the report was
Group—consistent with the department’s roles and issued and noted, among other things, the work that the
responsibilities, should work with relevant federal, state, territorial, department had done to manage the medical supply chain and
and tribal stakeholders to devise interim solutions, such as increase supply availability
systems and guidance and dissemination of best practices, to
help states enhance their ability to track the status of supply
requests and plan for supply needs for the remainder of the
COVID-19 pandemic response (September 2020 report).
Source GAO I GAO-21-396T

COVID-19 Health Available data from CDC and others demonstrate disparities in COVID-19
Disparities indicators by race and ethnicity, with communities of color bearing a
disproportionate burden of COVID-19 cases, hospitalizations, and deaths.
For example, the available data on COVID-19 hospitalizations show that
as of February 12, 2021, the rate of COVID-19-associated
hospitalizations for non-Hispanic American Indian/Alaska Native persons
is 3.7 times the rate for non-Hispanic White persons, when adjusting for

Page 9 GAO-21-396T
age. 8 Available data from CDC on the percentage of positive COVID-19
tests and on recipients of COVID-19 vaccinations also demonstrate racial
and ethnic disparities.

Testing. As of January 7, 2021, among COVID-19 diagnostic test
results reported to CDC from laboratories in 48 jurisdictions, the
percent of tests that were positive by each racial and ethnic group
was: 17.9 percent for Hispanic or Latino persons, 13.2 percent for
non-Hispanic Native Hawaiian or Other Pacific Islander persons, 12.4
percent for non-Hispanic American Indian/Alaska Native, and 11.2
percent for non-Hispanic Black persons, compared to 9.5 percent for
non-Hispanic White persons. 9
Vaccinations. Data showed disparities by race and ethnicity in vaccine
recipients who received at least one dose whose race and ethnicity
was known as of February 8, 2021:
• 62.9 percent were non-Hispanic White (compared to 60.1 percent
of the U.S. population),
• 8.9 percent were Hispanic or Latino (compared to 18.5 percent of
the U.S. population), and

8Hospitalization data through January 30, 2021, are from CDC’s COVID-19-Associated
Hospitalization Surveillance Network (COVID-NET), which collects data on COVID-19
hospitalizations that are confirmed by laboratory testing from select counties in 14 states,
representing 10 percent of the U.S. population. It includes data from hospitals in select
counties in California, Colorado, Connecticut, Georgia, Iowa, Maryland, Michigan,
Minnesota, New Mexico, New York, Ohio, Oregon, Tennessee, and Utah. American
Indian/Alaska Native, Asian, and Black, and White persons were non-Hispanic. Hispanic
or Latino persons might be of any race.
Age-adjusted case, hospitalization, and death rates were standardized to the 2019 U.S.
intercensal population. Age-adjusted rates, which hold constant the age distributions
between different population groups, allow researchers to focus analyses on other
demographics, such as race and ethnicity, without being concerned about differences that
are due to different age distributions of the racial and ethnic groups. Age-adjusted rates
are particularly important to consider for indicators of COVID-19 because persons in older
age groups are more likely to experience hospitalizations and racial and ethnic groups
have different age distributions in the U.S. population.
9Department of Health and Human Services, Centers for Disease Control and Prevention.
Report to Congress on Paycheck Protection Program and Health Care Enhancement Act
Disaggregated Data on U.S. Coronavirus Disease 2019 (COVID-19) Testing, 8th 30-Day
Update (January 2021). CDC data represent viral COVID-19 laboratory test results from
laboratories in the U.S., including commercial laboratories, public health laboratories, and
other testing locations from 48 jurisdictions. The data represent total laboratory tests, not
individual people, and exclude antibody and antigen tests.

Page 10 GAO-21-396T
• 5.9 percent were non-Hispanic Black (compared to 13.4 percent of
the U.S. population). 10
While CDC collects and makes race and ethnicity data on indicators of
COVID-19 available to the public, we found gaps in the data for COVID-
19 indicators. For example, as of February 2, 2021, race and ethnicity
was missing for 48.8 percent of COVID-19 cases with case report forms
received by CDC, or 61.5 percent of total cases reported. 11 Additionally,
as of February 8, 2021, data collected from states and jurisdictions on
race and ethnicity for COVID-19 vaccine recipients were missing for
almost half (45.6 percent) of recipients who received at least one dose.

We made three recommendations to address the gaps in race and
ethnicity data (see table 4). CDC agreed with the recommendations.

Table 4: GAO’s Recommendations Related to COVID-19 Health Disparities

Recommendation Status
As the Center for Disease Control and Prevention (CDC) Open. CDC agreed with our recommendation. In response to
implements its COVID-19 Response Health Equity Strategy, the our recommendation, CDC stated in January 2021 that the
Director of CDC should determine whether having the authority to agency is committed to having discussions, both internally and
require states and jurisdictions to report race and ethnicity with stakeholders, to assess whether having and implementing
information for COVID-19 cases, hospitalizations, and deaths is authority to require states and jurisdictions to report race and
necessary for ensuring more complete data and, if so, seek such ethnicity information for COVID-19 cases would result in
authority from Congress (September 2020 report). improved reporting.
As CDC implements its COVID-19 Response Health Equity Open. CDC agreed with our recommendation. In response to
Strategy, the Director of CDC should involve key stakeholders to our recommendation, CDC stated in January 2021 that the
help ensure the complete and consistent collection of demographic agency is working with state and local health departments, in
data (September 2020 report). addition to other stakeholders, to accelerate the reporting of
demographic data and improve data quality, including for
information on race and ethnicity.
As CDC implements its COVID-19 Response Health Equity Open. CDC agreed with our recommendation. In response to
Strategy, the Director of CDC should take steps to help ensure our recommendation, CDC noted in October 2020 that the
CDC’s ability to comprehensively assess the long-term health agency is convening a team to develop a plan to monitor the
outcomes of persons with COVID-19, including by race and ethnicity long-term health outcomes of persons with COVID-19 by
(September 2020 report). identifying health care surveillance systems that can
electronically report health conditions to state and local health
departments.
Source GAO I GAO-21-396T

10CDC COVID Data Tracker, https://covid.cdc.gov/covid-data-tracker/#vaccination-
demographic, accessed February 9, 2021.
11CDC officials reported that the number of cases with case report forms received by CDC
is less than the total number of reported cases because there is generally a 2-week lag
from when total cases are reported by state and jurisdictional health departments to when
CDC receives the case report forms. Total cases reported by CDC include both probable
and confirmed cases as reported by states or jurisdictions. A probable case does not have
confirmatory laboratory evidence, but meets certain other criteria.

Page 11 GAO-21-396T
COVID-19 Data Collection The federal government does not have a process to help systematically
and Standardization define and ensure the collection of standardized data across relevant
federal agencies and related stakeholders to help respond to COVID-19,
communicate the status of the pandemic with citizens, or prepare for
future pandemics. As a result, COVID-19 information that is collected and
reported by states and other entities to the federal government is often
incomplete and inconsistent.

The lack of complete and consistent data limits HHS’s and others’ ability
to monitor trends in the burden of the pandemic across states and
regions, make informed comparisons between such areas, and assess
the impact of public health actions to prevent and mitigate the spread of
COVID-19. Further, incomplete and inconsistent data have limited HHS’s
and others’ ability to prioritize the allocation of health resources in specific
geographic areas or among certain populations most affected by the
pandemic. For example, HHS’s data on COVID-19 in nursing homes do
not capture the first 4 months of the pandemic, because the agency did
not require nursing homes to report until May 8, 2020. The gaps in
reporting limits the usefulness of data in helping to understand the effects
of COVID-19 in nursing homes. GAO has made two recommendations to
improve the collection of data needed to respond to COVID-19 and
prepare for future pandemics.

In January 2021, we recommended that HHS immediately establish
an expert committee comprised of knowledgeable health care
professionals from the public and private sectors, academia, and
nonprofits or use an existing one to systematically review and
inform the alignment of ongoing data collection and reporting
standards for key health indicators.

In addition, in September 2020, we recommended that HHS, in
consultation with CMS and CDC, develop a strategy to capture more
complete data on COVID-19 cases and deaths in nursing homes
retroactively back to January 1, 2020.

In conclusion, we have made 16 recommendations to improve the
government’s pandemic response in the areas of COVID-19 testing,
vaccines and therapeutics, medical supply chain, COVID-19 health
disparities, and COVID-19 health data. Most of the recommendations
have not been implemented. We maintain that doing so would improve
the government’s response. We will continue to monitor the
implementation of our past recommendations as part of our ongoing

Page 12 GAO-21-396T
oversight of the government’s COVID-19 response and recovery efforts
on behalf of Congress.

Chairman Thompson, Ranking Member Katko, and Members of the
Committee, this concludes my prepared statement. I would be pleased to
respond to any questions that you may have at this time.

If you or your staff have any questions about this testimony, please
GAO Contact and contact A. Nicole Clowers, Managing Director, Health Care at (202) 512-
Staff 7114 or clowersa@gao.gov. Contact points for our Offices of
Congressional Relations and Public Affairs may be found on the last page
Acknowledgments of this statement. GAO staff who made key contributions to this testimony
are Tim Bushfield, Assistant Director; Jill Center, Analyst-in-Charge;
Jennie Apter, Robert Dougherty, Kelly Krinn, and Elaina Stephenson.

(105030)
Page 13 GAO-21-396T
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