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Highlights

What GAO Found

More than a year after the U.S. declared COVID-19 a public health emergency, the pandemic continues to result in catastrophic loss of life and substantial damage to the global economy, stability, and security. According to data from the Centers for Disease Control and Prevention’s (CDC) National Center for Health Statistics, about 520,000 more deaths occurred from all causes (COVID-19 and other causes) than would be normally expected from February 2020 through mid-February 2021, highlighting the effect of the pandemic on U.S. mortality (see figure). The pandemic also continues to cause economic challenges, particularly for the labor market. As of February 2021, there were about 10 million unemployed individuals, compared to nearly 5.8 million at the beginning of 2020.

Higher-Than-Expected Weekly Mortality in the U.S., February 2020 through Mid-February 2021

In the past year, GAO has made 44 recommendations for agency actions, 6 of which have been implemented. Since taking office, the new administration has taken some action consistent with GAO’s recommendations, such as issuing the National Strategy for the COVID-19 Response and Pandemic Preparedness and issuing executive orders calling for the development of a pandemic supply chain resilience strategy and providing emergency economic relief. GAO will continue to monitor the administration’s actions toward addressing GAO’s recommendations in future reporting.

In this report GAO is making 28 new recommendations in the areas of public health, the economy, and program integrity. Implementing these 28 recommendations, as well as 38 of GAO’s 44 prior recommendations that have not been fully implemented from CARES Act reports issued since June 2020, would improve the ongoing federal response to COVID-19.

GAO’s new recommendations are discussed below.

Hospital and Pharmacy Perspectives on COVID-19 Vaccine Administration and Medical Supply Availability

In February 2021, GAO surveyed hospitals and interviewed large retail pharmacy chains and an association of independent pharmacies to gain their perspectives on vaccine administration and medical supply availability. Providers expressed concerns about COVID-19 vaccine availability and limitations in the availability of certain key medical supplies for administering the vaccines—notably syringes and needles. For example, representatives from one retail pharmacy chain stated that the chain has the capacity to administer 25 million doses per month at 9,900 locations, but the chain’s initial allocation of vaccines from the federal government was expected to be only 230,000 doses at 250 locations. Several retail pharmacy chain representatives also indicated that limited vaccine availability has led to uncertainty regarding the amount of vaccines their pharmacies can expect to receive each week. The new administration has taken steps to increase certainty and vaccine availability. For example, the White House announced at the end of January 2021 that the federal government would begin notifying states earlier about availability and shipments of vaccines, to give greater certainty for planning vaccination efforts.

Of the 146 surveyed hospitals that plan to or have begun administering COVID-19 vaccines, 40 hospitals reported at the time of GAO’s survey being greatly concerned about having a sufficient quantity of syringes in the next 30 days for vaccine administration following the survey, and 43 hospitals were greatly concerned about having a sufficient quantity of needles. Additionally, shortages of personal protective equipment (PPE) and COVID-19 testing supplies also remain a challenge for some providers. GAO and other entities have documented persistent and evolving supply chain challenges throughout the pandemic, such as shortages of key supplies used for COVID-19 testing. GAO will continue to examine the medical supply chain, including the role of the Strategic National Stockpile, in future reporting, including actions to respond to GAO’s previous recommendations.

Emergency Use Authorizations

Emergency use authorizations (EUA)—which allow for the temporary use of unapproved medical products—have been instrumental in increasing needed supply of certain devices, such as PPE, during the COVID-19 pandemic response (see figure). However, there have been instances of inconsistencies between EUAs issued by the Food and Drug Administration (FDA) and device guidance from CDC and the Department of Labor (DOL), which led to confusion and hesitancy among providers about using such devices, according to provider associations. GAO recommends that FDA, CDC, and DOL work together to develop a process for sharing information to facilitate decision-making and guidance consistency related to devices with EUAs. The Department of Health and Human Services (HHS)—which includes FDA and CDC—and DOL agreed with this recommendation.

Examples of Medical Devices Other Than Tests with Emergency Use Authorizations for COVID-19

In addition, stakeholders—including associations representing manufacturers, distributors, and users of authorized devices, such as health care providers—raised concerns about what will happen to devices with EUAs after the declarations permitting their use for COVID-19 end. HHS has indicated that it intends to develop draft guidance for a transition plan for medical devices distributed under EUAs for COVID-19 by the end of fiscal year 2021. A plan for devices with EUAs that specifies a reasonable timeline and process for transitioning away from their use, taking into account stakeholder input, would help ensure a smooth transition. As HHS develops a transition plan for devices with EUAs, GAO recommends that the agency specify a reasonable timeline and process for transitioning authorized devices to clearance, approval, or appropriate disposition that takes into account input from stakeholders. HHS agreed with this recommendation.

COVID-19 Data for Health Care Indicators

Since June 2020, GAO has identified concerns with federal COVID-19 data and underscored that in the midst of a nationwide public health emergency, clear and consistent communication between the federal government and the public is critical given that effective response requires the public’s participation. As part of its efforts to communicate with the public and stakeholders about the pandemic, several experts suggested that the federal government should improve the accessibility of its COVID-19 data by making these data available from a central location on the internet. HHS publishes its data on COVID-19 health indicators across several websites. However, the data it makes publicly available are not all located on, or available from website links on, one online location. As a result, the public, including stakeholders, may not be able to fully understand the extent of the pandemic and use the data to best inform their decision-making.

To make the data more easily accessible, GAO recommends that HHS make its different sources of publicly available COVID-19 data accessible from a centralized location on the internet. HHS neither agreed nor disagreed with this recommendation, but agreed that COVID-19 data should be made accessible to support communication with the public about the pandemic.

COVID-19 Health Disparities

GAO previously reported that communities of color have been disproportionately affected by the pandemic. According to HHS, as of February 8, 2021, data collected from states and jurisdictions on COVID-19 vaccine recipients were missing data on race and ethnicity for almost half of recipients. Without complete information on the race and ethnicity of those vaccinated, HHS may have difficulty determining whether vaccines are distributed equitably to communities of color. GAO recommends that HHS take steps to ensure the complete reporting of race and ethnicity information for recipients of COVID-19 vaccinations. HHS neither agreed nor disagreed with this recommendation.

HHS’s July 2020 COVID-19 Response Health Equity Strategy has a goal to reduce health disparities by using data-driven approaches to attain the highest level of health possible for all individuals, including communities of color. However, the strategy lacks important elements of an effective national strategy. For example, HHS’s strategy does not provide specific actions that the agency will take to determine whether or where it needs to increase access to testing for populations at increased risk for COVID-19—an essential first step before taking steps to increase testing access. GAO recommends that HHS incorporate key elements of a national strategy to implement the agency’s COVID-19 Response Health Equity Strategy, including determining how intermediate outcomes should be prioritized . HHS agreed with this recommendation.

Nursing Homes

Collecting detailed information on vaccinations for nursing home populations is important for tracking and transparency, particularly because nursing homes have been an epicenter of the COVID-19 pandemic and HHS has recommended priority vaccinations for this group. HHS established a pharmacy partnership program for vaccinating staff and residents of long-term care facilities, and publicly reports the number of vaccination doses, by state, provided to residents and staff of all long-term care facilities participating in the program. However, HHS does not report data showing vaccination rates specifically for nursing homes and does not collect or report data for nursing homes not participating in the program. To improve the monitoring and transparency of nursing home vaccination efforts, GAO recommends that HHS collect data specific to COVID-19 vaccination rates in nursing homes and make these data publicly available. HHS neither agreed nor disagreed with this recommendation.

In addition, as of January 2021, HHS had not specified whether nursing homes would be required to offer COVID-19 vaccinations as they have with other vaccines and how these vaccinations would be incorporated into the agency’s nursing home quality strategy. Data on COVID-19 vaccinations in nursing homes will also be important for HHS’s ongoing efforts to monitor nursing home quality. GAO recommends that HHS require nursing homes to offer COVID-19 vaccinations to residents and staff and design and implement associated quality measures. HHS neither agreed nor disagreed with this recommendation.

Veterans Health Care

According to the Department of Veterans Affairs (VA), many veterans enrolled in VA’s health care system are at a higher risk of infection or severe disease from COVID-19 due to their age or underlying health conditions. GAO identified several areas where VA can improve its vaccination efforts:
  • VA does not have metrics related to staff and veterans who do not show (no-shows) for their vaccination appointments. Without data on no-shows, VA may be at risk for not being able to determine the extent to which staff and veterans are not showing up for appointments for their second vaccinations, and may miss opportunities to better target outreach to individuals not showing up for appointments.
  • VA lacks targets for when it will move from one vaccination phase to another or within one phase for when the agency will move from one group of veterans to another, making it difficult for the department to assess progress.
  • VA is utilizing a phased vaccine rollout; however, VA’s current metrics do not capture vaccine data by phases. As a result, VA is not able to determine which facilities may be at an earlier phase than others and direct resources or assistance to those facilities.

GAO recommends that VA (1) collect data on the number of staff and veterans who do not show up for a vaccination appointment to better monitor for completion of the second dose of the vaccine; (2) develop preliminary vaccination targets for when it will move from one vaccination phase to another; or within one phase, from one group of veterans to another; and (3) develop metrics to assess the number of vaccines administered by vaccine rollout phase to better assess progress and make any necessary adjustments. VA agreed with the first and third recommendations and agreed in principle with the second recommendation.

Nutrition Assistance

The U.S. Department of Agriculture (USDA) administers a number of federal nutrition assistance programs to vulnerable populations. Recent legislative and executive actions made several changes to these programs as the negative economic effects of the COVID-19 pandemic have continued. However, until recently, USDA had released minimal data about participation in these programs during the pandemic, and when the department released data in late January 2021, it did not publicly share sufficient information about data quality. In August 2020, USDA announced it had identified significant issues with the quality of state-reported data on two programs. As it worked to identify the root causes of the issues, USDA opted not to release participation data for any of its other nutrition assistance programs from July 2020 until late January 2021. When USDA released the data, the department did not explain how it resolved the data quality issues it previously disclosed, nor did it share necessary context to help stakeholders and the public understand and interpret the data.

As a result, stakeholders and the public lack sufficient information and appropriate context to interpret key program data and understand the effects of the pandemic on the programs. GAO recommends that USDA (1) provide sufficient context to help stakeholders and the public understand and interpret data on federal nutrition assistance programs during the pandemic and (2) disclose potential sources of error that may affect data quality during the pandemic, such as manual processing. USDA generally agreed with these recommendations.

Disaster Relief Fund and Assistance to Tribal Governments

Available data from HHS indicate that tribes are among communities of color bearing a disproportionate burden of COVID-19 positive tests, cases, hospitalizations, and deaths. The Federal Emergency Management Agency (FEMA), within the Department of Homeland Security (DHS), plays a key role in the ongoing COVID-19 pandemic response effort, including using the Disaster Relief Fund to provide Public Assistance grants to reimburse tribal governments, among others, for pandemic costs, such as testing supplies, PPE, and vaccine distribution.

Several tribal organizations reported challenges related to completing administrative requirements to request and receive Public Assistance. For example, two tribal officials told GAO that when requesting technical assistance from FEMA to help with disaster activities such as developing a Public Assistance Administrative Plan, FEMA did not have staff to assist. FEMA’s initial assessment report of its response to the pandemic noted challenges and recommended that FEMA develop a tribal nation engagement strategy that includes providing the resources and personnel throughout each region required to support program delivery for all tribal nations. However, as of March 2021, FEMA had not developed this strategy.

GAO recommends that FEMA provide timely and consistent technical assistance to support tribal governments’ efforts to request and receive Public Assistance as direct recipients, including providing additional personnel, if necessary, to ensure that tribal nations are able to effectively respond to COVID-19. DHS agreed with this recommendation.

FEMA’s 2019 Tribal Consultation Policy specifies the process for consulting with tribes throughout the four phases that guide the agency in how to conduct regular and meaningful collaboration with tribes (see figure). However, GAO found that FEMA did not follow the tribal consultation process while developing an interim policy detailing eligible items for reimbursement under the Public Assistance program. If tribes had been formally consulted earlier in the process, they could have been in a better position to provide meaningful input to FEMA on how its policy might impact tribes. Further, there may have been less confusion on which items were considered eligible for reimbursement during the early months of the pandemic, and tribes could have made more informed decisions. GAO recommends that FEMA adhere to the agency’s protocols listed in the updated 2019 Tribal Consultation Policy by obtaining tribal input via the four phases of the tribal consultation process when developing new policies and procedures related to COVID-19 assistance. DHS agreed with this recommendation.

Overview of FEMA’s Tribal Consultation Policy Process

K-12 Education

The Department of Education (Education) has taken steps to track state and school district spending of certain COVID-19 relief funds, but the data give an incomplete picture of the status of funds and understate the rate at which funds are being used. According to data collected by Education, as of February 28, 2021, states and territories have spent about $6.1 billion of the approximately $75 billion appropriated through the Education Stabilization Fund for states’ and territories’ education needs. However, federal spending data alone provide an incomplete picture of states’ and school districts’ spending, as there are several factors that influence the rate at which funds appear to be spent. For example, there is often a significant gap between when a district “uses” the funds (i.e., orders, contracts for, installs, and pays for goods or services, such as information technology equipment) and when those funds are reported as “spent” in state and federal reporting systems, as is common in federal grants management processes.

According to Education officials, states award applicable funds to school districts so that the school districts can obligate those funds for specific purposes. The state does not transfer funds to the district until the district requests payment for services or deliverables received. Education officials do not consider the funds spent until the state requests payment for expenses. Given this gap between when a district uses funds and funds are recorded as spent, absent information on obligations, policymakers will not have complete information on how these funds are being used to address the pandemic-related education needs of America’s schoolchildren. GAO recommends that Education regularly collect and publicly report information on school districts’ financial commitments (obligations), as well as outlays (expenditures) in order to more completely reflect the status of their use of federal COVID-19 relief funds. For example, Education could modify its annual report on state and school district spending data to include obligations data in subsequent reporting cycles. Education agreed with this recommendation.

Small Business Assistance Programs

The Consolidated Appropriations Act, 2021, appropriated additional funding for the creation of the Targeted Economic Injury Disaster Loan (EIDL) Advance program and authorized additional Paycheck Protection Program (PPP) loans, among other things, highlighting the continued need for ensuring program integrity. Since March 2020, the Department of Justice has publicly announced charges in numerous fraud-related cases associated with loans made through these programs. As a result of concerns about program integrity, GAO has added Small Business Administration (SBA) loans to GAO’s High Risk List. SBA has taken some steps to mitigate fraud risks to EIDL and PPP, but it has not taken a strategic approach to managing fraud risks to both programs. GAO recommends that SBA (1) implement a comprehensive oversight plan to identify and respond to risk in the EIDL program to ensure program integrity, achieve program effectiveness, and address potential fraud; (2) conduct and document a fraud risk assessment for the EIDL program and PPP; (3) develop a strategy that outlines specific actions to address assessed fraud risks in the EIDL program; and (4) outline specific actions to monitor and manage fraud risks in PPP on a continuous basis. SBA agreed with these recommendations.

Unemployment Insurance Programs

GAO continues to have concerns about overpayments and potential fraud in the unemployment insurance (UI) system, including the federally funded Pandemic Unemployment Assistance (PUA) program, which authorizes UI benefits to certain individuals not otherwise eligible for these benefits, such as self-employed and certain gig economy workers. As of March 15, 2021, DOL reported that states had identified more than $3.6 billion in PUA overpayments from March 2020 through February 2021. In response to a recommendation in GAO’s January 2021 report, DOL has taken steps to collect data on states’ recovery of PUA overpayments. However, the Consolidated Appropriations Act, 2021, enacted in December 2020, provided states with authority to waive certain PUA overpayments. Thus, additional data on the amounts of PUA overpayments states have waived are also needed to effectively monitor the recovery of overpayments. GAO recommends that DOL collect data from states on the amount of overpayments waived in the PUA program, similar to the regular UI program. DOL agreed with this recommendation.

This report contains additional recommendations related to transparency and accountability in the following areas: relief for health care providers, economic impact payments, federal contracts and agreements, audits of nonfederal entities receiving federal pandemic assistance, and employer tax relief and payroll tax deferrals.

GAO is also examining the federal government’s COVID-19 vaccine efforts, which will be the focus of an upcoming report. Finally, GAO will review actions federal agencies have taken in response to the American Rescue Plan of 2021 in future reporting.

Why GAO Did This Study

As of March 15, 2021, the U.S. had over 29 million reported cases of COVID-19 and more than 523,000 reported deaths, according to CDC. The country also continues to experience serious economic repercussions.

Five relief laws, including the CARES Act, were enacted as of January 31, 2021, to provide appropriations to address the public health and economic threats posed by COVID-19. As of January 31, 2021, of the $3.1 trillion appropriated by these five laws for COVID-19 relief, the federal government had obligated a total of $2.2 trillion and expended $1.9 trillion, as reported by federal agencies.

Most recently, in March 2021, a sixth relief law, the American Rescue Plan of 2021, was enacted and provides additional federal assistance for the ongoing response and recovery.

The CARES Act includes a provision for GAO to report on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. This report examines the federal government’s continued efforts to respond to and recover from the COVID-19 pandemic.

GAO reviewed data, documents, and guidance from federal agencies about their activities and interviewed federal and state officials, experts, and other stakeholders, including health care professionals.

What GAO Recommends

GAO is making 28 new recommendations for agencies that are detailed in this Highlights and in the report.

Recommendations

Recommendations for Executive Action

Recommendations for Executive Actions

We are making a total of 28 recommendations to federal agencies:
Number Agency Recommendation
1 Department of Health and Human Services

The Secretary of Health and Human Services should make the Department’s different sources of publicly available COVID-19 data accessible from a centralized location on the internet. This could improve the federal government’s communication with the public about the ongoing pandemic. See Health Care Indicators enclosure. (Recommendation 1)
2 Department of Health and Human Services

The Secretary of Health and Human Services should finalize and implement a post-payment review process to validate COVID-19 Uninsured Program claims and to help ensure timely identification of improper payments, including those resulting from potential fraudulent activity, and recovery of overpayments. See Relief for Health Care Providers enclosure. (Recommendation 2)
3 Department of Health and Human Services

The Secretary of Health and Human Services should ensure that the Director of the Centers for Disease Control and Prevention collects data specific to the COVID-19 vaccination rates in nursing homes and makes these data publicly available to better ensure transparency and that the necessary information is available to improve ongoing and future vaccination efforts for nursing home residents and staff. See Nursing Homes enclosure. (Recommendation 3)
4 Department of Health and Human Services

The Secretary of Health and Human Services should ensure that the Administrator of the Centers for Medicare & Medicaid Services, in consultation with the Centers for Disease Control and Prevention, requires nursing homes to offer COVID-19 vaccinations to residents and staff and design and implement associated quality measures. See Nursing Homes enclosure. (Recommendation 4)
5 Department of Veterans Affairs : Office of the Under Secretary for Health

The Department of Veterans Affairs Under Secretary for Health should develop metrics to assess the number of vaccines administered by vaccine rollout phase to better assess progress and make any necessary adjustments as needed. See Veterans Health Care enclosure. (Recommendation 5)
6 Department of Veterans Affairs : Office of the Under Secretary for Health

The Department of Veterans Affairs Under Secretary for Health should develop preliminary vaccination targets for when it will move from one vaccination phase to another; or within one phase, from one group of veterans to another. See Veterans Health Care enclosure. (Recommendation 6)
7 Department of Veterans Affairs : Office of the Under Secretary for Health

The Department of Veterans Affairs Under Secretary for Health should collect data on the number of staff and veterans who do not show up for a vaccination appointment to better monitor for completion of the second dose of the vaccine. See Veterans Health Care enclosure. (Recommendation 7)
8 Department of Health and Human Services

The Secretary of Health and Human Services should ensure that the Food and Drug Administration and the Centers for Disease Control and Prevention work with the Assistant Secretary of Labor for Occupational Safety and Health to develop a process for sharing information to facilitate decision-making and guidance consistency related to devices with emergency use authorization. See Emergency Use Authorizations for Medical Devices enclosure. (Recommendation 8)
9 Department of Labor : Occupational Safety and Health Administration

The Assistant Secretary of Labor for Occupational Safety and Health should work with the Food and Drug Administration and the Centers for Disease Control and Prevention to develop a process for sharing information to facilitate decision-making and guidance consistency related to devices with emergency use authorization. See Emergency Use Authorizations for Medical Devices enclosure. (Recommendation 9)
10 Department of Health and Human Services : Food and Drug Administration

As the Food and Drug Administration develops a transition plan for devices with emergency use authorizations, the Commissioner should specify a reasonable timeline and process for transitioning authorized devices to clearance, approval, or appropriate disposition that takes into account input from stakeholders. See Emergency Use Authorizations for Medical Devices enclosure. (Recommendation 10)
11 Department of Health and Human Services : Public Health Service : Centers for Disease Control and Prevention

The Director of the Centers for Disease Control and Prevention should incorporate key elements of a national strategy in the agency’s COVID-19 Response Health Equity Strategy. These elements include (1) specific actions to achieve intermediate outcomes, such as increased access to testing; (2) how intermediate outcomes should be prioritized within its four broad priority areas; (3) who will implement actions to achieve intermediate outcomes; and (4) how the strategy relates to other relevant strategies. See Health Disparities enclosure. (Recommendation 11)
12 Department of Health and Human Services : Public Health Service : Centers for Disease Control and Prevention

The Director of the Centers for Disease Control and Prevention should take steps to ensure more complete reporting of race and ethnicity information for recipients of COVID-19 vaccinations, such as working with states and jurisdictions to facilitate consistent collecting and reporting of this information. See Health Disparities enclosure. (Recommendation 12)
13 Department of Agriculture : Office of the Secretary

The Secretary of Agriculture should direct the Administrator of the Agricultural Marketing Service to issue guidance—such as an acquisition alert or a reminder to contracting officials—on the use of the COVID-19 National Interest Action code for the Farmers to Families Food Box Program or successor food distribution program to ensure it accurately captures COVID-19-related contract obligations in support of the program. See Federal Contracts and Agreements for COVID-19 enclosure. (Recommendation 13)
14 Department of Agriculture : Office of the Secretary

The Secretary of Agriculture should direct the Administrator of the Agricultural Marketing Service to assess the contracting personnel needed to fully execute the award and administration of existing contracts in support of the Farmers to Families Food Box Program or successor future food distribution program, and take the necessary steps to ensure it has adequate contracting staff in place to award and administer any future contracts for the program. See Federal Contracts and Agreements for COVID-19 enclosure. (Recommendation 14)
15 Department of Labor

The Secretary of Labor should ensure the Office of Unemployment Insurance collects data from states on the amount of overpayments waived in the Pandemic Unemployment Assistance program, similar to the regular unemployment insurance program. See Unemployment Insurance Programs enclosure. (Recommendation 15)
16 Department of the Treasury : Internal Revenue Service

The Commissioner of Internal Revenue should periodically review control activities for issuing direct payments to individuals to determine that the activities are designed and implemented appropriately as IRS disburses a third round of Economic Impact Payments and prepares for advance payments on the Child Tax Credit. These control activities should include appropriate testing procedures, quality assurance reviews, and processes that ensure payments distributed by tax partners reach the intended recipients. See Economic Impact Payments enclosure. (Recommendation 16)
17 Department of Agriculture : Office of the Secretary

The Secretary of Agriculture should ensure that the Administrator of the Food and Nutrition Service (1) provides sufficient context to help stakeholders and the public understand and interpret data on federal nutrition assistance programs during the pandemic and (2) discloses potential sources of error that may affect data quality during the pandemic, such as manual processing. For example, the agency could publish key information from its internal communications plan that it developed for the January 2021 data release and include additional table notes in subsequent data releases to help explain these issues. See Nutrition Assistance enclosure. (Recommendation 17)
18 Department of the Treasury : Internal Revenue Service

The Commissioner of Internal Revenue should leverage employee counts from Form 941, Employer’s Quarterly Federal Tax Return, and Form 943, Employer’s Annual Federal Tax Return for Agricultural Employees, to identify potentially ineligible COVID-19 related sick and family leave credit claims, and address discrepancies the Internal Revenue Service deems significant. See Employer Tax Relief and Payroll Tax Deferrals enclosure. (Recommendation 18)
19 Department of the Treasury : Internal Revenue Service

The Commissioner of Internal Revenue should conduct outreach to employment tax return filers to educate and promote accurate reporting of employee counts on Form 941, Employer’s Quarterly Federal Tax Return, and Form 943, Employer’s Annual Federal Tax Return for Agricultural Employees. See See Employer Tax Relief and Payroll Tax Deferrals enclosure. (Recommendation 19)
20 Small Business Administration

The Administrator of the Small Business Administration should conduct and document a fraud risk assessment for the Economic Injury Disaster Loan program. See Economic Injury Disaster Loan Program enclosure. (Recommendation 20)
21 Small Business Administration

The Administrator of the Small Business Administration should develop a strategy that outlines specific actions to address assessed fraud risks in the Economic Injury Disaster Loan program on a continuous basis. See Economic Injury Disaster Loan Program enclosure. (Recommendation 21)
22 Small Business Administration

The Administrator of the Small Business Administration should implement a comprehensive oversight plan to identify and respond to risks in the Economic Injury Disaster Loan program to help ensure program integrity, achieve program effectiveness, and address potential fraud. See Economic Injury Disaster Loan Program enclosure. (Recommendation 22)
23 Small Business Administration

The Administrator of the Small Business Administration should conduct and document a fraud risk assessment for the Paycheck Protection Program. See Paycheck Protection Program enclosure. (Recommendation 23)
24 Small Business Administration

The Administrator of the Small Business Administration should develop a strategy that outlines specific actions to monitor and manage fraud risks in the Paycheck Protection Program on a continuous basis. See Paycheck Protection Program enclosure. (Recommendation 24)
25 Department of Homeland Security : Directorate of Emergency Preparedness and Response : Federal Emergency Management Agency

The Federal Emergency Management Agency Administrator should adhere to the agency’s protocols listed in its updated 2019 Tribal Consultation Policy by obtaining tribal input via the four phases of the tribal consultation process when developing new policies and procedures related to COVID-19 assistance. See FEMA’s Disaster Relief Fund and Assistance to Tribal Governments enclosure. (Recommendation 25)
26 Department of Homeland Security : Directorate of Emergency Preparedness and Response : Federal Emergency Management Agency

The Federal Emergency Management Agency Administrator should provide timely and consistent technical assistance to support tribal governments’ efforts to request and receive Public Assistance as direct recipients, including providing additional personnel, if necessary, to ensure that tribal nations are able to effectively respond to COVID-19. See FEMA’s Disaster Relief Fund and Assistance to Tribal Governments enclosure. (Recommendation 26)
27 Department of Education : Office of the Secretary

The Secretary of Education should regularly collect and publicly report information on school districts’ financial commitments (obligations), as well as outlays (expenditures) in order to more completely reflect the status of their use of federal COVID-19 relief funds. For example, Education could modify its annual report on state and school district spending data to include obligations data in subsequent reporting cycles. See K-12 Education enclosure. (Recommendation 27)
28 Executive Office of the President : Office of Management and Budget

The Director of the Office of Management and Budget should work in consultation with federal agencies and the audit community (e.g., agency Offices of Inspector General; National Association of State Auditors, Comptrollers, and Treasurers; and American Institute of Certified Public Accountants), to the extent practicable, to incorporate appropriate measures in the Office of Management and Budget’s process for preparing single audit guidance, including the annual Single Audit Compliance Supplement, to better ensure that such guidance is issued in a timely manner and is responsive to users’ input and needs. See Single Audits enclosure. (Recommendation 28)
View recommendation(s) status

Introduction 


Congressional Committees

More than a year after the Secretary of Health and Human Services first declared a public health emergency for the U.S. and the World Health Organization characterized the Coronavirus Disease 2019 (COVID-19) as a pandemic, COVID-19 continues to result in catastrophic loss of life and substantial damage to the global economy, stability, and security. [1] Worldwide, as of March 15, 2021, there were more than 119,452,000 reported cases and about 2,648,000 reported deaths due to COVID-19; within the U.S., there were about 29,270,000 reported cases and more than 523,000 reported deaths. [2]

The country also continues to experience serious economic repercussions and turmoil as a result of the pandemic. As of February 2021, there were about 10 million unemployed individuals, compared to nearly 5.8 million individuals at the beginning of 2020. [3]

In March 2020, Congress took action in response to this unprecedented global crisis to protect the health and well-being of Americans. Notably, 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 businesses affected by COVID-19. [4] Over the past year, agencies from across the federal government have demonstrated extraordinary dedication and commitment to responding to the unprecedented COVID-19 pandemic, including those serving on the front lines to establish and sustain services for those infected with the virus.

Since the enactment of the CARES Act—which includes a provision for GAO to report bimonthly on its ongoing efforts related to the pandemic—we have continued to monitor and oversee the federal government’s efforts to prepare for, respond to, and recover from the COVID-19 pandemic. [5] To date, we have issued six reports in response to this provision, made 44 recommendations to federal agencies, and raised four matters for congressional consideration to improve the federal government’s response efforts. [6]

Since taking office, the new administration has taken some action consistent with our recommendations, such as issuing the National Strategy for the COVID-19 Response and Pandemic Preparedness and issuing executive orders calling for the development of a pandemic supply chain resilience strategy and providing emergency economic relief. We will continue to monitor the administration’s actions towards addressing our recommendations in future reporting. Agencies should swiftly take action on the 38 prior recommendations that have not been fully implemented from our CARES Act reports issued since June 2020, including those on topics such as addressing potential fraud, developing national testing and vaccine strategies, and providing clear and consistent communication.

We are also examining the federal government’s COVID-19 vaccine efforts, which will be the focus of an upcoming report. In addition, we have issued other targeted COVID-19-related report in areas such as Federal Reserve lending programs supported by CARES Act funds, the Defense Production Act, and the CARES Act loan program for aviation and other eligible businesses, and we have reviews ongoing in these and other areas. [7] Additionally, we will review actions federal agencies have taken in response to the American Rescue Plan of 2021 in future reporting.

This report examines the federal government’s continued efforts to respond to and recover from the COVID-19 pandemic. We make 28 new recommendations to federal agencies in areas including relief for health care providers, veterans’ health care, nursing homes, federal contracts and agreements for the COVID-19 response, the Paycheck Protection Program, and unemployment insurance programs.

This report also includes 46 enclosures about a range of federal programs and activities across the government concerning public health and the economy. (See Appendix I ) Figure 1 lists these enclosures by topic area and highlights those with new recommendations.

Figure 1: Report Enclosures by Topic Area

Given the government-wide scope of this report, we undertook a variety of methodologies to complete our work, including examining a wide range of data sources and conducting interviews with federal and state officials and representatives from stakeholder groups including health care professionals and other entities. Among other things, we examined federal laws, agency documents, and guidance. In each enclosure, we include a summary of the methodology specific to the work conducted.

See Appendix II for a list of ongoing GAO work related to COVID-19 and Appendix III for the status of matters for congressional consideration and recommendations for executive action made in our June, September, November 2020, and January 2021 CARES Act reports and in our November 2020 report on vaccines and therapeutics.

We conducted this performance audit from October 2020 to March 2021 in accordance with generally accepted government auditing standards. 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 the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives.

Background 


Public Health and Economic Effects

The number of new reported COVID-19 cases reached a high in January 2021 and decreased considerably in February. Between February 25 and March 10, 2021, new reported COVID-19 cases averaged about 65,000 per day, which was about a quarter of the peak that occurred during the winter of 2021 and similar to the peak that occurred during the summer of 2020 (see fig. 2). [8] During this same 2-week period, reported new COVID-19 cases per day, on average, increased in 5 jurisdictions, held steady in 18 jurisdictions, and decreased in 28 jurisdictions. [9]

The need to remain vigilant in efforts to contain the spread of the virus is underscored by the emergence of new variants of the virus, 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. The virus also continues to be an obstacle to a more robust economic recovery.

Figure 2: Reported COVID-19 Cases per Day in the U.S., through March 10, 2021

Note: Reported COVID-19 cases include confirmed and probable cases. Beginning April 14, 2020, states could include probable as well as confirmed COVID-19 cases in their reports to CDC. Prior to that time, counts only included confirmed cases. According to CDC, the actual number of cases is unknown for a variety of reasons, including that people who have been infected may not have been tested or may have not sought medical care. The data were accessed on March 15, 2021.

According to data from the Centers for Disease Control and Prevention’s (CDC) National Center for Health Statistics, about 520,000 more deaths occurred from all causes (COVID-19 and other causes) than would be normally expected from February 2020 through mid-February 2021, highlighting the effect of the pandemic on U.S. mortality (see fig. 3).

Figure 3: Higher-Than-Expected Weekly Mortality, February 2020 through mid-February 2021

Note: The figure shows the number of deaths from all causes in a given week through February 13, 2021, reported in the U.S. that exceeded the upper bound threshold of expected deaths calculated by CDC’s National Center for Health Statistics on the basis of variation in mortality experienced in prior years. See CDC’s National Center for Health Statistics webpage on excess deaths for further details on how CDC estimates this upper bound threshold: https://www.cdc.gov/nchs/nvss/vsrr/covid19/excess_deaths.htm , accessed on March 15, 2021. The number of deaths in recent weeks should be interpreted cautiously as this figure relies on provisional data that are generally less complete.

Providing the public with safe and effective vaccines to protect people from getting sick with COVID-19 is crucial to mitigating the public health and economic impacts of the virus and ending the pandemic. It is also a time-sensitive undertaking, with over 6 million cases of COVID-19 and 95,704 deaths reported in the United States in the month of January 2021 alone. Two, two-dose COVID-19 vaccines were authorized for emergency use in December 2020 and a third, one-dose vaccine was authorized in February 2021. [10] Doses of COVID-19 vaccine administered each day have steadily increased from December 14, 2020 through March 10, 2021, with a temporary dip in February due to severe weather across the country (see fig. 4). As of March 15, 2021, about 109,082,000 doses had been administered, according to CDC.

Figure 4: Daily Count of Doses of COVID-19 Vaccine Administered and Reported to CDC, through March 10 2021

Note: Data show the number of COVID-19 vaccine doses administered in the U.S. as reported to CDC by state, territorial, and local public health agencies, and federal entities, since the national vaccine program began on December 14, 2020, and include doses administered through all vaccine partners including jurisdictional partner clinics, retail pharmacies, long-term care facilities, Federal Emergency Management Agency and Health Resources and Services Administration partner sites, and federal entity facilities. The data were accessed on March 15, 2021. As of March 15, 2021, three COVID-19 vaccines were authorized for emergency use; two of these vaccines are two-dose regimens and the third vaccine requires one dose. The number of doses administered on a given day may be affected by several factors, such as weekend days, holidays, weather, and vaccine availability. On February 19, 2021, officials from the White House COVID-19 Response Team said in a press briefing that severe weather across the country impacted vaccine distribution and administration in all 50 states. Further, officials said the shipment of 3 days’ worth—about 6 million doses—of vaccines was delayed due to weather.

In addition to the public health effects, the pandemic continues to cause economic challenges, particularly for the labor market. For example, in February 2021, the employment-to-population ratio, which measures the share of the population employed, was 3.5 percentage points lower than in February 2020, indicating that labor market conditions remain worse than in the pre-pandemic period (see fig. 5). [11]

Figure 5: Employment Remains below Its Pre-pandemic Level, as of February 2021

The pandemic has affected some sectors of the economy much more than others. In particular, sectors like leisure and hospitality, mining and logging, and education have seen the largest losses in employment during the pandemic. Importantly, individuals working in the leisure and hospitality sector historically have had the lowest average earnings among sectors and, moreover, during the pandemic have seen the most significant job losses, and many low-wage workers remained out of work as of February 2021 (see fig. 6).

Figure 6: Percentage Change in Employment by Sector, February 2020–February 2021

Federal COVID-19 Funding and Spending

In response to the far-reaching public health and economic crises, Congress has passed, and the President has signed, legislation to fund recovery efforts for COVID-19 (COVID-19 relief laws). Figure 7 shows the COVID-19 relief laws enacted from March 2020 through March 11, 2021.

Figure 7: COVID-19 Relief Laws Enacted, as of March 11, 2021

Note: The figure shows selected COVID-19-related federal legislation. It does not show all of the COVID-19-related actions taken by Congress and the administration. Additional federal actions, such as the enactment of legislation providing limited and targeted relief to certain individuals and presidential actions authorizing federal support for states and individuals, also occurred during this time frame. Amounts for the first five COVID-19 relief laws are based on appropriation warrant information provided by the Department of the Treasury (Treasury) as of January 31, 2021. These amounts have increased over time and could increase in the future for programs with indefinite appropriations, which are appropriations that, at the time of enactment, are for an unspecified amount. The amount for the American Rescue Plan Act of 2021 is based on estimates made by the Congressional Budget Office.
aThe Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, provided $7.8 billion to agencies for health emergency prevention, preparedness, and response activities related to COVID-19, with the Department of Health and Human Services receiving a majority of the funds. Pub. L. No. 116-123, 134 Stat. 146.
bThe Families First Coronavirus Response Act provided supplemental appropriations for nutrition assistance programs and public health services and authorized the Internal Revenue Service to provide tax credits for paid emergency sick leave and expanded family medical leave that the act required certain employers to provide. In addition, the act provided states with flexibility to temporarily modify provisions of their unemployment insurance laws and policies related to certain eligibility requirements and provided additional federal financial support to the states. Pub. L. No. 116-127, 134 Stat. 178 (2020).
cThe CARES Act provided supplemental appropriations for federal agencies to respond to COVID-19. In addition, it also funded various loans, grants, and other forms of assistance for businesses, industries, states, local governments, and hospitals; provided tax rebates for certain individuals; temporarily expanded unemployment benefits; and suspended payments and interest on federal student loans. Pub. L. No. 116-136, 134 Stat. 281 (2020).
dThe Paycheck Protection Program and Health Care Enhancement Act provided additional appropriations for small business loans, grants to health care providers, and COVID-19 testing. Pub. L. No. 116-139, 134 Stat. 620 (2020).
eThe Consolidated Appropriations Act, 2021, expanded or extended several CARES Act programs, including unemployment insurance programs, economic impact payments, and Paycheck Protection Program loans, and rescinded unobligated funds for certain programs. Pub. L. No. 116-260, 134 Stat. 1182 (2020). As of January 31, 2021, Treasury issued about $948.0 billion in warrants for appropriations for COVID-19 relief. In addition, approximately $478.8 billion from Treasury’s Economic Stabilization and Assistance to Distressed Sectors programs and $146.5 billion from the Small Business Administration’s Business Loans Program was rescinded, in response to the Consolidated Appropriations Act, 2021.
fThe American Rescue Plan Act of 2021 provided additional relief to address the continued impact of COVID-19 on the economy, public health, state and local governments, individuals, and businesses. The Congressional Budget Office estimates the budgetary effects of the law to be $1.9 trillion. Pub. L. No. 117-2, 135 Stat. 4.

As of January 31, 2021, about $3.1 trillion had been appropriated to fund response and recovery efforts for—as well as to mitigate the public health, economic, and homeland security effects of—COVID-19. [12] As of January 31, 2021, the most recent date for which government-wide information was available at the time of our analysis, the federal government had obligated a total of $2.2 trillion and expended $1.9 trillion of the COVID-19 relief funds as reported by federal agencies to the Department of the Treasury’s (Treasury) Governmentwide Treasury Account Symbol Adjusted Trial Balance System (GTAS). [13]

Eight spending areas—the Business Loan Programs, unemployment insurance, economic impact payments, Public Health and Social Services Emergency Fund, Coronavirus Relief Fund, Education Stabilization Fund, Disaster Loans Programs, and Economic Stabilization and Assistance to Distressed Sectors programs—represent $2.6 trillion, or 84 percent, of the total amounts appropriated. [14] For these eight largest spending areas, agencies reported obligations totaling $2.0 trillion and expenditures totaling $1.7 trillion as of January 31, 2021. Table 1 provides additional details on appropriations, obligations, and expenditures of government-wide COVID-19 relief funds, including the eight largest spending areas.
Table 1: COVID-19 Relief Appropriations, Obligations, and Expenditures, as of January 31, 2021

Major spending area

Total appropriations a
($ billions)

Total obligations b
($ billions)

Total expenditures b
($ billions)

Business Loan Programs
(Small Business Administration)

830.7c

611.3

538.1d

Unemployment Insurance
(Department of Labor)

651.8

437.8

424.1

Economic Impact Payments
(Department of the Treasury)

455.3

415.0

415.0

Public Health and Social Services Emergency Fund
(Department of Health and Human Services)

280.0

195.0

133.9

Coronavirus Relief Fund
(Department of the Treasury)

150.0

150.0

149.5

Education Stabilization Fund
(Department of Education)

112.6

100.0

16.6

Disaster Loans Programs
(Small Business Administration)

50.6

26.4

24.7d

Economic Stabilization and Assistance to Distressed Sectors
(Department of the Treasury)

21.2e

21.1

19.5d

Other Areas

504.3

216.4

194.9

Total f

3,056.6

2,172.9

1,916.2
Source: GAO analysis of data from the Department of the Treasury and applicable agencies. | GAO-21-387

aCOVID-19 relief appropriations reflect amounts appropriated under 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); CARES Act, Pub. L. No. 116-136, 134 Stat. 281 (2020); Families First Coronavirus Response Act, Pub. L. No. 116-127, 134 Stat. 178 (2020); and Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, Pub. L. No. 116-123, 134 Stat. 146. These amounts are based on appropriation warrant information provided by the Department of the Treasury as of January 31, 2021. These amounts have increased over time and could increase in the future for programs with indefinite appropriations, which are appropriations that, at the time of enactment, are for an unspecified amount. In addition, this table does not represent transfers of funds that federal agencies may make between appropriation accounts or transfers of funds they may make to other agencies.
bObligation and expenditure data are based on data reported by applicable agencies.
cThe Consolidated Appropriations Act, 2021, rescinded $146.5 billion from the Small Business Administration’s Business Loans Programs.
dThese expenditures relate mostly to the loan subsidy costs (the loan’s estimated long-term costs to the U.S. government).
eEconomic Stabilization and Assistance to Distressed Sectors programs received $500 billion in appropriations from the CARES Act, approximately $478.8 billion was rescinded in response to the Consolidated Appropriations Act, 2021.
fThe sum of amounts may not agree due to rounding.

Key Principles for an Effective Federal Response

Throughout our reporting in response to the CARES Act, we have identified and continued to reinforce the importance of key principles that are essential for an effective federal response based on our prior work examining responses to public health and fiscal emergencies. Specifically, federal agencies should
  • coordinate, establish, and define roles and responsibilities among those responding to the crisis;
  • provide clear, consistent communication;
  • collect and analyze data to inform decision-making and future preparedness;
  • establish clear goals; and
  • establish mechanisms for accountability and transparency to help ensure program integrity and address fraud risks.

As the nation enters the second year of the COVID-19 pandemic, these principles remain important factors in the federal response to the crisis and a focus of our oversight. In our 2021 High-Risk report, we added Small Business Administration (SBA) loans to our High-Risk List because of concerns about program integrity. [15] In addition, in that report, we discuss other important challenges facing our nation that merit continuing close attention as emerging issues of concern, including Department of Health and Human Services’ (HHS) leadership and coordination of public health emergencies. We will determine whether the leadership and coordination issue should be added to the High-Risk List once we have completed ongoing and planned work in this area.

Executive Summary 

Overview

In this report we are making 28 new recommendations across the federal government in the areas of public health and the economy. As Congress and the administration carry out plans for the federal government’s ongoing COVID-19 response, we urge action on these 28 recommendations, as well as 38 of our 44 prior recommendations that have not been fully implemented from six CARES Act reports. For a summary and the status of all prior recommendations from these reports, see Appendix III .

Hospital and Pharmacy Perspectives on COVID-19 Vaccine Administration and Medical Supply Availability

In February 2021, we surveyed 383 hospitals and interviewed nine large retail pharmacy chains and an association of independent pharmacies to gain their perspectives on vaccine administration and medical supply availability. Providers expressed concerns about COVID-19 vaccine availability and limitations in certain key medical supplies for administering the vaccines—notably syringes and needles. Reported concerns included the following.
  • Vaccine availability. Of the 166 total hospitals that responded to our survey, 102 (61 percent) reported not having sufficient information to respond to questions from their staff, the public, and others about vaccine availability. In addition, 35 hospitals (21 percent) described concerns with general vaccine availability in open-ended survey responses. Similarly, our interviews with officials representing retail pharmacy chains and an association of independent pharmacies also revealed concerns about vaccine availability. For example, representatives from one retail pharmacy chain stated that the chain has the capacity to administer 25 million doses per month at 9,900 locations, but the chain’s initial allocation of vaccines from the federal government was expected to be only 230,000 doses at 250 locations.

    Several retail pharmacy chain representatives also indicated that limited vaccine availability has led to uncertainty regarding the amount of vaccines their pharmacies can expect to receive each week. The new administration has taken steps to increase certainty and vaccine availability. For example, the White House announced at the end of January 2021 that the federal government would begin notifying states earlier about availability and shipments of vaccines, to give greater certainty for planning vaccination efforts.
  • Availability of syringes and needles. Out of the 146 hospitals that reported they have either begun administering COVID-19 vaccines or plan to do so, 40 hospitals (27 percent) reported being greatly concerned about having a sufficient quantity of syringes in the next 30 days, and 43 hospitals (29 percent) were greatly concerned about having a sufficient quantity of needles.
  • Capacity to administer COVID-19 vaccines. In addition to supplies, administering vaccines requires managing vaccine orders as well as having additional storage, staff, and information technology system capacity. Some of the most commonly cited concerns include having the ability to track the expected arrival of vaccine orders, having a sufficient number of trained providers to administer vaccines, and storing vaccines in ultra-cold storage.

Shortages of personal protective equipment (PPE) and COVID-19 testing supplies also remain a challenge for some providers.
  • PPE supply. Most of the 166 hospitals that responded to our survey reported having an adequate 7-day supply of the 11 types of PPE we asked about in our survey. However, in some cases, hospitals reported avoiding shortages only with reuse or extending the use of the items. For example, 37 hospitals (23 percent) reported needing to reuse or extend the use of N95 respirators in order to have a 7-day supply. Representatives from all nine retail pharmacy chains reported being confident or very confident their pharmacies could access 30 days or more of PPE, and independent pharmacies generally reported sufficient access. See our enclosure on the Strategic National Stockpile and the Medical Supply Chain in appendix I for additional information and recommendations related to the medical supply chain.
  • Testing supplies. Most of the surveyed hospitals conducting COVID-19 diagnostic testing reported having at least a 7-day supply of testing supplies we asked about in our survey. However, hospitals were somewhat less confident about levels of those same supplies over the next 15 days. Representatives of the retail pharmacy chains and independent pharmacies that conduct COVID-19 testing did not report current problems accessing testing supplies. See our enclosure on Funding for COVID-19 Testing in appendix I for more information on testing issues.

Along with other entities, we have documented persistent and evolving supply chain challenges throughout the pandemic, such as shortages of key supplies used for COVID-19 testing. We will continue to examine the medical supply chain, including the role of the Strategic National Stockpile, in future reporting.

SNS and Medical Supply Chain

The Strategic National Stockpile (SNS), overseen by HHS, is a federal stockpile of vaccines, pharmaceuticals, and medical supplies and devices designed to be deployed to support the response to a public health emergency. [16] The near depletion of the SNS early in the COVID-19 response raised questions among the state officials and experts we interviewed about the role and expectations of the SNS during a nationwide pandemic. However, HHS officials told us that the SNS was not designed to provide states with supplies for a prolonged nationwide event such as the COVID-19 pandemic; it is primarily designed to respond to discrete and localized events.

Over the course of our CARES Act work, we have reported on efforts to modernize and restructure the SNS, including progress toward building a 90-day supply of certain key types of PPE, including eye protection or face shields, gowns, gloves, and N95 respirators, in order to respond to future surges in COVID-19 cases. According to HHS officials, they were aiming to meet their 90-day targets of certain PPE by the end of 2020; however, they also noted that they had to balance replenishing the stockpile with ensuring adequate commercial availability. As such, HHS reported delayed delivery of some items to the SNS to enable manufacturers to make them available in the commercial market to alleviate supply constraints. According to HHS data from February 2021, the SNS has reached, or almost reached, its 90-day targets for N95 respirators, surgical or procedural masks, and eye protection or face shields. However, supplies of gloves and gowns or coveralls remain far from their 90-day targets.

As we reported in January 2021, reexamining the role of the SNS in the U.S. response to pandemics will require difficult policy decisions and trade-offs about systems, budgets, and authorities. Stockpiling the SNS for the near term could help address the challenges faced at the beginning of the pandemic response, including the quality and quantity of supplies provided, and allow for more targeted allocation strategies. However, HHS officials were uncertain whether they would maintain the current 90-day target supply levels beyond the COVID-19 response.

In January 2021, the President signed an Executive Order calling for the development of a pandemic supply chain resilience strategy to design, build, and sustain a long-term capability to manufacture medical supplies for future pandemics and biological threats. [17] Per the order, this strategy is to include the role of the SNS in (1) providing and allocating supplies across state, local, tribal, and territorial governments, (2) sustaining supplies during a pandemic, and (3) contingency planning, among other things, within 180 days. [18] As we previously recommended, a process for regularly engaging with Congress and stakeholders in the development and implementation of a medical supply chain strategy to enhance pandemic response capabilities—to include the role of the SNS—would help guide this complex transformation.

Additionally, the Consolidated Appropriations Act, 2021, included a provision requiring the President to make publicly available a report containing a whole-of-government plan for effective response to subsequent COVID-19 outbreaks and for future global pandemic diseases. [19] The act stipulates that this pandemic plan should address how to improve the role of the federal government with respect to the regulation, acquisition, and disbursement of medical supplies necessary to respond to COVID-19 as well as the procurement and distribution of PPE, among other things. See the Strategic National Stockpile and the Medical Supply Chain enclosure in appendix I for additional information.

Funding for COVID-19 Testing

Diagnostic testing for COVID-19 is critical to controlling and understanding the spread of the virus, according to HHS. Overall, HHS reported total testing-specific obligations of about $42.9 billion as of February 28, 2021. A majority of this funding was obligated to states, localities, territories, and tribal organizations, but funding was also used by HHS agencies for testing-related activities, such as procurement of testing supplies and funding for testing for the uninsured.

Officials from all nine selected jurisdictions we spoke with in January 2021 told us that they had sufficient funding to meet their immediate testing goals. [20] While it appears as though a relatively small percentage (about 7 percent) of the federal testing funding obligated for state, local, and territorial jurisdictions has been expended, we found this is due, in part, to funding availability time frames. For example, officials from six of nine selected jurisdictions told us they or their members prioritized spending federal funds whose availability ended earliest. However, more than half of selected jurisdictions told us they had concerns about maintaining testing capacity and preparedness in the longer term. While the supplemental funding has helped jurisdictions address needs to respond to the pandemic in the short term, most jurisdictions interviewed for this report had concerns about future testing and related preparedness. The American Rescue Plan of 2021, enacted on March 11, 2021, includes funding for implementation of a national testing strategy, manufacturing and procurement of tests, and assistance to state, local, and territorial health departments. [21] The additional assistance may help ameliorate concerns about the sufficiency of funding for COVID-19 testing in the longer term. See the Funding for COVID-19 Testing enclosure in appendix I for additional information.

Emergency Use Authorizations

Generally, medical devices must be cleared or approved by the Food and Drug Administration (FDA) to be marketed in the U.S.; however, the Secretary of Health and Human Services may declare that circumstances exist justifying the authorization of emergency use of certain medical products, including devices. [22] Such emergency use authorizations (EUA) allow for the temporary use of unapproved medical products or unapproved uses of approved medical products, provided certain statutory criteria are met. [23] EUAs have been instrumental in increasing needed supply of certain devices, such as PPE, during the COVID-19 pandemic response. However, there have been instances of inconsistencies between EUAs issued by FDA and device guidance from CDC and the Department of Labor (DOL)—agencies that also have a role in ensuring proper use of respirators and other devices. [24] Such inconsistencies led to confusion and hesitancy among health care providers about using devices with EUAs, according to health care provider association officials, and may have undermined the use of these critical medical products early in the pandemic. We recommend that FDA, CDC, and DOL work together to develop a process for sharing information to facilitate decision-making and guidance consistency related to devices with EUAs. HHS—which includes FDA and CDC—and DOL agreed with this recommendation.

Additionally, officials representing health care providers, device manufacturers, and distributors raised a number of concerns about what will happen to authorized devices after the declarations permitting their use for COVID-19 end. [25] The Secretary of Health and Human Services is required to provide advance notice prior to the termination of the EUA declarations and consult with manufacturers about proper disposition of authorized devices. HHS has indicated that it intends to develop draft guidance for a transition plan for medical devices distributed under EUAs for COVID-19 by the end of the fiscal year 2021. As of March 15, 2021, the agency had not released a draft plan to provide a transition for the use of these devices. Specifying a reasonable timeline and process for transitioning away from use of authorized devices before the EUA declarations end, taking into account stakeholder input, would help ensure a smooth transition.

We also recommend that as HHS develops a transition plan for devices with EUAs, it should specify a reasonable timeline and process for transitioning authorized devices to clearance, approval, or appropriate disposition that takes into account input from stakeholders. HHS agreed with this recommendation. See the Emergency Use Authorizations for Medical Devices enclosure in appendix I for additional information.

COVID-19 Data for Health Care Indicators

Since June 2020, we have identified concerns with federal COVID-19 data, and we have underscored that in the midst of a nationwide public health emergency, clear and consistent communication between the federal government and the public is critical given that effective response requires the public’s participation.

As part of its efforts to communicate with the public and stakeholders about the pandemic, several experts suggested to us that the federal government should make federal COVID-19 data more accessible, such as by making them available from a central online location. HHS publishes its data on COVID-19 health indicators across several websites, but does not make all of the data accessible from a central online location. That is, all of its publicly available data are not located on, or available from website links on, one online location. As a result, the public, including stakeholders, may not be able to fully understand the extent of the pandemic and use the data to best inform their decision-making.

We are recommending that HHS make its different sources of publicly available COVID-19 data accessible from a centralized location on the internet. This could improve the federal government’s communication with the public about the ongoing pandemic. HHS neither agreed nor disagreed with our recommendation, but it agreed that COVID-19 data should be made accessible to support communication with the public about the pandemic.

See the Health Care Indicators enclosure in appendix I for more information.

COVID-19 Health Disparities

We have previously reported that communities of color have been disproportionately affected by the pandemic. We continue to emphasize the need for HHS to implement our recommendation to improve data collection and work with stakeholders to identify and address COVID-19-related racial and ethnic disparities.

HHS released its COVID-19 Response Health Equity Strategy in July 2020 with a goal to reduce health disparities by using data-driven approaches to attain the highest level of health possible for all individuals, including communities of color. We found that HHS’s equity strategy does not include important elements of an effective national strategy, as defined by our prior work. For example, HHS’s strategy includes an intermediate outcome to increase access to testing for populations at increased risk for COVID-19. However, HHS’s strategy does not provide specific actions that the agency will take to determine whether or where it needs to increase access to testing for populations at increased risk for COVID-19—an essential first step before taking steps to increase testing access. By including these elements, HHS can better ensure the effective implementation of its equity strategy to help improve the health outcomes of populations disproportionately affected by COVID-19, including communities of color.

Improving completeness of race and ethnicity data for COVID-19 vaccinations is critical to federal efforts to advance equity. HHS plans to reach disproportionately affected communities through vaccination strategies, including plans to collect and report timely, complete, and representative data on COVID-19 vaccinations. However, according to HHS, as of February 8, 2021, data from states and jurisdictions on race and ethnicity were missing for almost half (45.6 percent) of COVID-19 vaccine recipients. HHS stated that this information is missing for a variety of reasons, including a lack of consistent data collection and reporting by physicians and pharmacists and challenges with transmitting data to HHS. Without complete information on the race and ethnicity of persons who have received COVID-19 vaccines, HHS may have difficulty determining whether vaccines are distributed equitably to communities of color who have been disproportionately affected by COVID-19.

We are recommending that HHS incorporate key elements of a national strategy in its COVID-19 Response Health Equity Strategy, including specific actions to achieve intermediate outcomes and determining how they should be prioritized. HHS agreed with this recommendation. In addition, we are recommending that HHS take steps to ensure more complete reporting of race and ethnicity information for recipients of COVID-19 vaccinations. HHS neither agreed nor disagreed with this recommendation. See the Health Disparities enclosure in appendix I for more information.

Relief for Health Care Providers

The Provider Relief Fund, which reimburses eligible providers for health-care-related expenses or lost revenues attributable to COVID-19, includes an allocation for the COVID-19 Uninsured Program. [26] Although HHS officials have not yet determined the total amount to be used for this program, as of March 1, 2021, approximately $2.2 billion from the Provider Relief Fund had been disbursed for COVID-19 treatment, testing, and vaccine administration of uninsured individuals. Providers who choose to participate in this program must attest to its terms and conditions, which include that the individual treated, tested, or administered a vaccine is uninsured, that the provider will accept reimbursement as payment in full, and that the provider will not bill the individual for the balance of the bill.

HHS’s risk assessment identified the potential for providers to falsify patients as being uninsured as a risk for the COVID-19 Uninsured Program. [27] HHS officials told us that HHS intends to perform post-payment reviews of claims to validate certain provider attestations. However, HHS did not have documentation describing how it plans to conduct these reviews. Without documented post-payment review policies and procedures and timely implementation of related control activities, HHS’s ability to consistently identify and recover improper payments will be limited, and the agency’s efforts to recover the payments identified as overpayments will be delayed, or the payments may not be recovered.

We are recommending that HHS finalize and implement a post-payment review process to validate COVID-19 Uninsured Program claims and to help ensure timely identification of improper payments, including those resulting from potential fraudulent activity, and recovery of overpayments. HHS agreed with the recommendation. See the Relief for Health Care Providers enclosure in appendix I for more information.

Nursing Homes

The health and safety of the 1.4 million elderly or disabled residents in the nation’s more than 15,000 Medicare- and Medicaid-certified nursing homes—who are often in frail health and living in close proximity to one another—has been of particular concern during the COVID-19 pandemic. According to HHS case-reporting data, as of February 7, 2021, more than 99 percent of Medicare- and Medicaid-certified U.S. nursing homes had reported at least one confirmed resident or staff case, and more than 80 percent had reported at least one resident or staff COVID-19 death.

Collecting detailed information on vaccinations for nursing home populations is important for tracking and transparency, particularly because nursing homes have been an epicenter of the pandemic and because HHS has recommended priority vaccinations for this group. The National Strategy for the COVID-19 Response and Pandemic Preparedness notes that agencies should share data on COVID-19 response and recovery efforts and that these data should be publicly available to support performance tracking and ensure transparency.

HHS collects data and publicly reports the number of vaccination doses, by state, provided to residents and staff of all long-term care providers participating in an HHS pharmacy partnership program for vaccinations in long-term care facilities. However, HHS does not publicly report data showing vaccination rates specifically for nursing homes and does not collect or report vaccination data for nursing homes not participating in this program. According to HHS, it does not report specifically for nursing homes because of concerns that such data would not accurately reflect vaccination rates in nursing homes—for example, some residents may have received their first dose before being admitted. Without public reporting of these data, it is unclear to what extent efforts to vaccinate nursing home residents have been successful, and it may be difficult to use these data to improve ongoing and future vaccination efforts for the nursing home population.

Further, since 2005, HHS has required nursing homes to offer influenza and pneumococcal vaccinations to nursing home residents. Data on these vaccinations are a key part of HHS’s oversight of nursing home infection prevention and control practices. However, as of January 2021, HHS had not specified whether nursing homes would be required to offer COVID-19 vaccinations or how these vaccinations would be incorporated into its requirements or quality measures for nursing homes. These data are important because they could help manage the risk of COVID-19 outbreaks in nursing homes and serve as an important source of information for consumers about quality of care, making the collection of complete vaccination rate data critical for any quality measures developed.

We are recommending that HHS (1) collect data specific to COVID-19 vaccination rates in nursing homes and make these data publicly available; and (2) require nursing homes to offer COVID-19 vaccinations to residents and staff and design and implement associated quality measures. HHS neither agreed nor disagreed with these recommendations. See the Nursing Homes enclosure in appendix I for more information.

Veterans Health Care

According to the Department of Veterans Affairs (VA), many veterans enrolled in VA’s health care system are at a higher risk of infection or severe disease from COVID-19 due to their age or underlying health conditions. VA developed and began executing a COVID-19 vaccination plan following the emergency use authorization of the Pfizer COVID-19 vaccine in December 2020. We identified several areas where VA can improve its vaccination efforts:
  • VA is utilizing a phased vaccine rollout; however, VA’s current metrics do not capture vaccine data by phases. Specifically, VA has metrics for vaccinations by veteran age and by high-risk condition, but these metrics do not provide information on vaccinations by phase, because phases may include veterans based on a combination of factors. For example, phase 1c includes veterans who are over the age of 65 and veterans under the age of 65 who have high-risk conditions. VA officials said that they only collect data required by CDC. Without the ability to review vaccination data by phase, VA is not able to determine which facilities may be at an earlier phase than others and direct resources or assistance to those facilities.
  • VA lacks targets for when it will move from one vaccination phase to another—or within one phase, from one group of veterans to another—making it difficult for the department to assess progress. According to VA, creating vaccination targets is challenging given that vaccine supply currently lags demand, and the amount of vaccine available to VA is unpredictable and fluctuates from week to week. As of March 10, 2021, VA had fully vaccinated—that is, administered two required doses of the Moderna or Pfizer vaccines, or one dose of the Janssen vaccine—to about 908,000 veterans out of the roughly 10 million currently enrolled in VA’s health care system and about 243,000 VA staff out of approximately 419,000. However, without preliminary targets, VA may not be able to assess the progress of its vaccination effort and signal to other groups when they might anticipate being vaccinated.
  • VA does not have metrics related to staff and veterans who do not show up for their vaccination appointments (no-shows), which is inconsistent with its own vaccination goal to track vaccine administration and completion of both doses of vaccine. Without data on no-shows, VA may be at an increased risk of not being able to determine the extent to which staff and veterans are not showing for appointments for their second vaccinations, and may miss opportunities to better target outreach to individuals not showing up for appointments. Officials told us that VA is collecting data required by CDC, which do not include no-show appointments.

We are recommending that VA (1) develop metrics to assess the number of vaccines administered by vaccine rollout phase to better assess progress and make any necessary adjustments as needed; (2) develop preliminary vaccination targets for when it will move from one vaccination phase to another—or within one phase, from one group of veterans to another—and (3) collect data on the number of staff and veterans who do not show up for a vaccination appointment to better monitor for completion of the second dose of the vaccine. VA agreed with our first and third recommendations and agreed in principle with our second recommendation. See the Veterans Health Care enclosure in appendix I for more information.

Nutrition Assistance

The U.S. Department of Agriculture (USDA) administers a number of federal nutrition assistance programs to vulnerable populations. Recent legislative and executive actions made several changes to these programs as the negative economic effects of the COVID-19 pandemic have continued. For example, benefits for the largest of these programs—the Supplemental Nutrition Assistance Program (SNAP), administered by USDA’s Food and Nutrition Service (FNS)—were increased by 15 percent from January through September 2021 for all participants, according to USDA. [28] Additionally, eligibility was temporarily expanded to certain vulnerable populations.

Until recently, USDA had released minimal data about participation in these programs during the pandemic, and when the department released data in late January 2021, it did not publicly share sufficient information about data quality. In August 2020, USDA announced that it had identified significant issues with the quality of state-reported data on two programs, leading to larger-than-actual estimates for SNAP participation. As it worked to identify the root causes of the SNAP data issues, USDA opted not to release participation data for any of its other nutrition assistance programs from July 2020 until late January 2021. When USDA released the data, the department did not explain how it resolved the data quality issues it previously disclosed, nor did it share necessary context to help stakeholders and the public understand and interpret the data, such as the potential for error that manual adjustments to data may introduce.

Office of Management and Budget (OMB) guidelines direct agencies to consider the usefulness of information they disseminate to intended users, including the public, and state that the information should be presented in an accurate, clear, complete, and unbiased manner, and within a proper context, and that agencies should disclose any sources of error that affect data quality. Because the department has not published information on its efforts to address prior data quality issues or disclosed potential sources of error, stakeholders and the public lack sufficient information and appropriate context to interpret key program data and understand the effects of the pandemic on the programs. We are recommending that USDA (1) provide sufficient context to help stakeholders and the public understand and interpret data on federal nutrition assistance programs during the pandemic and (2) disclose potential sources of error that may affect data quality during the pandemic, such as manual processing. USDA generally agreed with our recommendations.

See the Nutrition Assistance enclosure in appendix I for more information.

Disaster Relief Fund and Assistance to Tribal Governments

The Federal Emergency Management Agency (FEMA), within the Department of Homeland Security (DHS), continues to play a key role in the ongoing COVID-19 pandemic response effort, including using the Disaster Relief Fund to provide Public Assistance grants. [29] Public Assistance grants reimburse tribal governments, among others, for pandemic costs, such as testing supplies, PPE, and vaccine distribution.

Several tribal organizations reported challenges related to completing administrative requirements to request and receive Public Assistance as a direct recipient during the pandemic––requirements such as activating an emergency operations plan and submitting a tribal Public Assistance Administrative Plan. [30] While tribal representatives reported that some tribal nations received technical assistance, many other tribal nations were given little or no technical assistance when they requested support. For example, two tribal officials told us that when requesting technical assistance from FEMA to help with disaster activities, FEMA did not have staff available to assist. FEMA’s Tribal Pilot Guidance states that tribes may request technical assistance from FEMA to develop a disaster-specific Public Assistance Administrative Plan. Without the availability of consistent and timely technical assistance across regions, some tribal entities may be unable to request and receive Public Assistance directly from FEMA to help respond to the COVID-19 pandemic.

FEMA’s initial assessment report of its response to the pandemic noted challenges and recommended that FEMA develop a tribal nation engagement strategy that includes providing the resources and personnel throughout each region required to support program delivery for all tribal nations. However, as of March 2021, FEMA had not developed this strategy.

We are recommending that FEMA provide timely and consistent technical assistance to support tribal governments’ efforts to request and receive Public Assistance as direct recipients, including providing additional personnel, if necessary, to ensure that tribal nations are able to effectively respond to COVID-19. DHS agreed with our recommendation.

In addition, in May 2020, multiple tribal associations reported that DHS and FEMA did not formally consult with tribes for COVID-19 pandemic policies that have tribal implications. [31] In 2019, FEMA issued its Tribal Consultation Policy, which specifies the process for how FEMA engages with tribal governments in regular and meaningful consultation and collaboration on actions that have tribal implications. [32]

FEMA did not follow the tribal consultation process while developing an interim policy detailing eligible items for reimbursement under the Public Assistance program. FEMA officials agreed that this interim policy has tribal implications but the agency did not formally consult with tribes while developing the interim policy because they did not have the time due to the expedited nature of that policy and the immediate need to respond to questions from states, tribes, territories, and localities.

As a result, FEMA issued an interim policy clarifying the types of items and activities eligible for COVID-19 Public Assistance without tribal input. If tribes had been formally consulted earlier in the process, they could have been in a better position to provide meaningful input to FEMA on how its policy might impact tribes before FEMA issued the policy in September 2020. Further, there may have been less confusion on which items were considered eligible for reimbursement during the early months of the pandemic, and tribes could have made more informed decisions.

We are recommending that FEMA adhere to the agency’s protocols listed in its updated 2019 Tribal Consultation Policy by obtaining tribal input via the four phases of its tribal consultation process when developing new policies and procedures related to COVID-19 assistance. DHS agreed with our recommendation.

See the enclosure on FEMA’s Disaster Relief Fund and Assistance to Tribal Governments in appendix I for more information.

K-12 Education

The Department of Education (Education) has taken steps to track state and school district spending of certain COVID-19 relief funds, but the data give an incomplete picture of the status of funds. [33] According to data collected by Education, as of February 28, 2021, states and territories had spent about $6.1 billion of the approximately $75 billion appropriated for education. However, federal spending data alone provide an incomplete picture of states’ and school districts’ spending, as there are several factors that influence the rate at which funds appear to be spent.

For example, there is often a significant gap between when a district “uses” the funds (i.e., when the district orders, contracts for, installs, and pays for goods or services, such as information technology equipment) and when those funds are reported as “spent” in state and federal reporting systems, as is common in federal grants management processes. According to Education officials, states award applicable funds to school districts so that the school districts can obligate those funds to specific purposes. The state does not transfer funds to the district until the district requests payment for services or deliverables received. Education officials do not consider the funds to have been spent until the state requests payment for expenses.

Both Education and Congress have recognized the importance of accurately capturing the status of COVID-19 relief funds provided to states and school districts to inform the department’s monitoring and technical assistance, and to provide transparency to the public about uses of the funds. However, given the gap between when a district uses funds and funds are recorded as spent, without complete information on obligations, policymakers will not have information on how these funds are being used to address the pandemic-related education needs of America’s schoolchildren.

We are recommending that Education regularly collect and publicly report information on school districts’ financial commitments (obligations), as well as outlays (expenditures), in order to more completely reflect the status of their use of federal COVID-19 relief funds. For example, Education could modify its annual report on state and school district spending data to include obligations data in subsequent reporting cycles. Education agreed with our recommendation. See the K-12 Education enclosure in appendix I for more information.

Economic Impact Payments

The CARES Act and the Consolidated Appropriations Act, 2021, authorized Treasury and the Internal Revenue Service (IRS) to issue economic impact payments (EIP) as direct payments to help individuals address financial stress due to the pandemic. [34] Treasury and IRS quickly issued the second round of direct payments to most eligible individuals. As of February 28, 2021, Treasury and IRS had issued 168.2 million payments totaling $275.9 billion for the first round of payments (EIP 1) and 152.4 million payments totaling $147 billion for the second round of payments (EIP 2).

In December 2020, Treasury and IRS sent an estimated 13 to 19 million EIP 2 payments to temporary bank accounts. As a result, millions of individuals experienced a delay of up to a month to receive their EIP 2. Tax industry partners, such as tax preparers and tax financial services companies, had established these temporary accounts on behalf of their clients to receive tax refunds.

IRS officials said the EIP 2 payments were sent to the temporary bank accounts due to an error. These officials added that IRS attempted to address the issue of temporary bank accounts after EIP 1 but instead uploaded the wrong information for some accounts for EIP 2. IRS did not become aware of the error until December 31, 2020, when its tax industry partners notified it that EIP 2 payments had been sent to the temporary accounts. IRS officials said they did not perform a quality review of the revised records. According to officials, they were working under a compressed time frame, and preparing for the 2021 filing season.

IRS has documented quality review procedures for its operations. However, according to officials, they did not consistently follow these procedures for the second round of direct payments. With the enactment of the American Rescue Plan of 2021, which includes a third round of economic impact payments and advance payments of the Child Tax Credit, timely reviews of control activities for making direct payments to individuals could help IRS avoid costly or burdensome errors in the future. [35]

We are recommending that IRS periodically review control activities for issuing direct payments to individuals to determine that the activities are designed and implemented appropriately as IRS disburses a third round of EIPs and prepares for advance payments on the Child Tax Credit. These control activities should include appropriate testing procedures, quality assurance reviews, and processes that ensure payments distributed by tax partners reach the intended recipients. IRS disagreed with our recommendation. However, IRS acknowledged that it established additional procedures and reviews upon discovering that it had sent millions of payments to the wrong account. IRS stated it plans to assess the effectiveness of these new controls during the next round of Economic Impact Payments and will adjust them as warranted.

See the Economic Impact Payments enclosure in appendix I for more information.

Economic Injury Disaster Loan Program and Paycheck Protection Program

The Consolidated Appropriations Act, 2021, appropriated additional funding for the creation of the Targeted Economic Injury Disaster Loan (EIDL) Advance program and authorized additional Paycheck Protection Program (PPP) loans, among other things, highlighting the continued need for ensuring program integrity. [36] On March 11, 2021, the American Rescue Plan Act of 2021 appropriated additional funding for entities that qualified for targeted EIDL advances under the Consolidated Appropriations Act, 2021, including setting aside a portion for smaller and more economically impacted businesses in low-income communities. [37] The American Rescue Plan Act of 2021 also appropriated additional funding for PPP loans.

Since March 2020, the Department of Justice (DOJ) has publicly announced charges in numerous fraud-related cases across the country, including charges of identity theft, wire and bank fraud, and money laundering. See the Federal Fraud-Related Cases enclosure in appendix I for more information. For example:
  • From May 2020 to February 2021, DOJ publicly announced charges in over 30 fraud-related cases associated with EIDL loans, charging over 50 defendants.
  • From May 2020 to February 2021, DOJ publicly announced charges in over 100 fraud-related cases associated with PPP loans, charging over 170 defendants.
  • As of February 2021, at least five defendants had pleaded guilty to federal charges of defrauding the EIDL program, and at least 30 defendants had pleaded guilty to federal charges of defrauding PPP.

Law enforcement officials we spoke with noted a large number of ongoing investigations and hotline complaints related to CARES Act loans, including loans made under the EIDL program and PPP. For example, according to a senior official at SBA’s Office of Inspector General (OIG), as of January 2021, the agency had opened more than 260 investigations related to CARES Act loans and received over 70,000 hotline complaints—both far exceeding numbers the office would typically receive in a year. Law enforcement officials also reported systemic patterns of fraud across EIDL and PPP investigations, including identity theft, false attestations on loan documents, misuse of proceeds, and fictitious and inflated employee counts. SBA officials told us that for EIDL, SBA is supporting many of the DOJ and SBA OIG investigations of EIDL through a team that researches case files, responds to inquiries from law enforcement agencies, and shares data on suspected fraud cases with the SBA OIG, DOJ, and U.S. Secret Service.

SBA has taken some steps to mitigate fraud risks to EIDL and PPP, such as identifying and addressing risks on a loan-level basis for both programs, but has not taken a strategic approach to managing fraud risks. We are recommending that SBA (1) conduct and document fraud risk assessments for the EIDL program and PPP, (2) develop a strategy that outlines specific actions to address assessed fraud risks in the EIDL program, and (3) outline specific actions to monitor and manage fraud risks in PPP on a continuous basis. SBA agreed with our recommendations.

In addition, in December 2020, SBA’s independent financial statement auditor stated that SBA was unable to provide adequate documentation to support a significant number of transactions and account balances related to EIDL due to inadequate processes and controls. The auditor noted discrepancies including more than one loan or advance approved and disbursed to the same borrower, and identified over 6,000 disbursed EIDL loans (over $212 million total) issued to potentially ineligible borrowers. [38] The auditor noted that SBA management did not properly design and implement overall effective management controls to account for new and expanded programs, such as EIDL, under the CARES Act and related legislation. [39] In response to the audit findings, SBA did recognize that documentation of its processes and controls was not sufficiently well developed to support the financial statement audit and stated that it is working diligently to correct any shortcomings for future audits. As a result of concerns about program integrity, we have added SBA loans to GAO’s High Risk List. We are recommending that SBA implement a comprehensive oversight plan to identify and respond to risks in the EIDL program to help ensure program integrity, achieve program effectiveness, and address potential fraud. SBA agreed with our recommendation.

See the Economic Injury Disaster Loan Program and the Paycheck Protection Program enclosures in appendix I for more information.

Unemployment Insurance Programs

We continue to have concerns about overpayments and potential fraud in the unemployment insurance (UI) system, including DOL’s federally funded Pandemic Unemployment Assistance (PUA) program, which authorizes benefits to certain individuals not otherwise eligible for other UI benefits, such as self-employed and certain gig economy workers.

For example, according to DOJ, from March 2020 through January 2021, DOJ filed federal charges against 92 individuals for defrauding the UI programs and an additional 11 individuals pleaded guilty to federal charges. [40] See the Federal Fraud-Related Cases enclosure in appendix I for more information.

In addition, as of March 15, 2021, DOL reported that states had identified more than $3.6 billion in PUA overpayments from March 2020 through February 2021. [41] As of March 15, 2021, DOL reported that states had identified about $2.6 billion in regular UI overpayments during the pandemic, in the final 3 quarters of 2020 combined. Overpayments are not necessarily a result of fraud, though some may be.

In response to the recommendation in our January 2021 report that DOL collect data from states on the amounts of overpayments recovered in the PUA program, DOL has taken steps to collect data on states’ recovery of PUA overpayments. As of March 15, 2021, 14 states had begun reporting some overpayment recovery data to DOL. However, the Consolidated Appropriations Act, 2021, enacted on December 27, 2020, provided states authority to waive certain PUA overpayments. [42] Therefore, additional data on the amounts of PUA overpayments states have waived are also needed to effectively monitor the recovery of overpayments. The large amount of already-reported PUA overpayments (about $3.6 billion as of March 15, 2021) indicates the need for timely data to monitor and support states’ use of overpayment waivers. According to DOL, states are able to retroactively waive PUA overpayments from the beginning of the program onward; waived overpayments do not have to be recovered. However, DOL did not include PUA overpayments waived in updated state reporting requirements issued in early 2021 because, according to officials, the agency needed to quickly issue guidance on new PUA provisions in the Consolidated Appropriations Act, 2021. In early February, DOL officials told us they did not have plans to collect data on which states are utilizing the authority to waive PUA overpayments or the amount of overpayments that states have waived. In a subsequent meeting in late February, DOL officials responded that they were developing requirements for states to report these data, which would be included in a future round of guidance.

We are recommending that DOL collect data from states on the amount of overpayments waived in the PUA program, similar to the regular UI program. DOL agreed with our recommendation. See the Unemployment Insurance Programs enclosure in appendix I for more information.

Federal Contracts and Agreements for the COVID-19 Response

Federal contracting activity continues to play a critical role in response to the pandemic. As of February 28, 2020, agencies obligated more than $55 billion on contracts to support the COVID-19 response, including $5.2 billion obligated by USDA. Nearly all of USDA’s obligations supported the Farmers to Families Food Box Program—a program implemented in May 2020 to assist commodity suppliers impacted by the pandemic and to provide food assistance to the public. However, USDA faced some data reporting challenges for its Farmers to Families Food Box Program. For example, in February 2021, we found that over $1.2 billion in obligations for the program were not reported with the COVID-19 National Interest Action (NIA) code. The COVID-19 NIA code was established on March 13, 2020, to enable the consistent tracking of COVID-19 contracting actions in the Federal Procurement Data System-Next Generation. USDA has since corrected the data reporting issues we identified, but has not established guidance for its contracting officials to ensure these challenges do not persist. USDA also experienced challenges compiling complete contract documentation for its contract awards. According to USDA officials, the hundreds of contract actions for the program have largely been executed by a small staff of one contracting officer and seven contracting specialists. A contracting official told us the speed with which the contracts were executed and the sheer volume of awards may have affected officials’ ability to ensure accurate contract reporting and the compilation of complete contract files.

Without guidance reinforcing the need to use the NIA code to track Farmers to Families Food Box contract actions, USDA may continue to face challenges reporting quality information on billions of dollars in contract activity to the public—including congressional decision makers, entities with oversight responsibilities, and taxpayers. Further, without assessing the workforce needed to manage existing contracts that underpin the program and any future food distribution contracts, USDA cannot ensure that the challenges the department has encountered with contract reporting and management of contract documentation are addressed, particularly given that additional funding continues to be provided to support pandemic-related food distribution efforts. USDA has taken some steps to mitigate these issues, including using a different contracting approach and completing a workforce reorganization. However, the challenges we found related to inaccurate contract reporting and incomplete contract files have persisted even after the change in contracting strategy. USDA has not assessed whether additional contracting officers will be assigned to support the program as of February 2021.

We are recommending that USDA (1) issue guidance—such as an acquisition alert or a reminder to contracting officials–on the use of the NIA code for the Farmers to Families Food Box Program or successor food distribution program to ensure it accurately captures COVID-19-related contract obligations in support of the program and (2) assess the contracting personnel needed to fully execute the award and administration of existing contracts in support of the program or successor food distribution program, and take the necessary steps to ensure it has adequate contracting staff in place to award and administer any future contract awards for the program. USDA neither agreed nor disagreed with our recommendations. See the Federal Contracts and Agreements for COVID-19 enclosure in appendix I for more information.

Single Audits

Single audits—required for non-federal entities that receive federal awards when their award expenditures meet a certain dollar threshold amount in a fiscal year—help identify deficiencies in the award recipients’ compliance with applicable laws and regulations, help ensure the appropriate use of federal funds, and reduce the likelihood of federal improper payments. [43]

Through provisions enacted in the COVID-19 relief laws, the federal government has provided billions of dollars to non-federal entities that must undergo these single audits when their award expenditures meet the threshold. [44] Each year, OMB, after consultation with federal agencies, issues a tool that auditors rely on that consolidates applicable legal requirements for numerous programs into one central place, called a Compliance Supplement. [45] OMB’s 2020 Compliance Supplement—issued in August 2020—was incomplete despite numerous audits already being underway. OMB released an addendum to the supplement in December 2020.

The lag between the distribution of COVID-19 relief funds to recipients and OMB’s issuance of single audit guidance contributed to delays in auditors conducting single audits and reporting the results, which may lead to inconsistent reporting and affect award recipients’ development of corrective actions. A process for timely preparing and providing the guidance contained in OMB’s annual Compliance Supplements to auditors is essential to help ensure that single audits can be performed timely and enhance the federal government’s ability to help safeguard billions of dollars in federal funds, including those provided under COVID-19 relief laws.

In addition to providing timely guidance, it is also essential that OMB establish and maintain a clear process that provides adequate time to work with stakeholders—including federal agencies and the audit community—to determine needed changes to more fully address their input and concerns, which in turn could help ensure the quality of the guidance. This is especially critical going forward given the magnitude of COVID-19 relief funding. OMB stated that it solicits comments from members of the audit community, and makes revisions as appropriate, prior to issuing its final annual Compliance Supplement. However, it is unclear to members of the audit community what OMB’s decision-making process is for resolving concerns raised during the comment period.

We are recommending that OMB work in consultation with federal agencies and the audit community (e.g., agency OIGs; National Association of State Auditors, Comptrollers and Treasurers; and American Institute of Certified Public Accountants), to the extent practicable, to incorporate appropriate measures in OMB’s process for preparing single audit guidance, including the annual Single Audit Compliance Supplement, to better ensure that such guidance is issued in a timely manner and is responsive to users’ input and needs. OMB neither agreed nor disagreed with our recommendation.

See the Single Audits enclosure in appendix I for more information.

Employer Tax Relief and Payroll Tax Deferrals

The Families First Coronavirus Response Act and the CARES Act provided tax credits to covered employers to mitigate the cost of paid sick and family leave for employees affected by COVID-19, among other tax relief, and the Consolidated Appropriations Act, 2021, amended and extended some of these credits. [46] Our analysis of IRS data showed that 3,379 employers that claimed a Families First Coronavirus Response Act leave tax credit may be ineligible for the credit, based on our review of employee counts reported on tax forms employers submit to IRS. [47]

Because the employee counts on these employer tax forms only account for one pay period during each quarter, they are therefore imperfect determinants of eligibility for the tax credit. However, they could serve as a screening tool. For example, because only employers with fewer than 500 employees are eligible for these credits, employers that report 500 or more employees on these forms could be contacted and asked to resolve the discrepancy or return any credit claims for which they were not eligible.

While IRS conducts compliance examinations for these tax forms, resource constraints at the agency allow for only a small number of examinations (0.1 percent of employment tax filings per fiscal year 2019); as a result, IRS risks not identifying and addressing a large percentage of potentially ineligible claims.

We are recommending that IRS leverage employee counts from its tax forms to identify potentially ineligible COVID-19-related sick and family leave credit claims and address discrepancies IRS deems significant. This approach could be less resource intensive than the examinations that IRS currently conducts. We are also recommending that IRS conduct outreach to employment tax return filers to educate and promote accurate reporting of employee counts on its tax forms. IRS agreed with both of our recommendations.

See the Employer Tax Relief and Payroll Tax Deferrals enclosure in appendix I for more information.

Conclusions 


With the issuance of this report, we have now made 72 recommendations to federal agencies and four matters for congressional consideration to improve the federal response to COVID-19. These recommendations are tailored to specific federal programs and initiatives, and, if implemented, will strengthen the efficiency, effectiveness, and accountability of federal efforts. We will continue to monitor the status of these recommendations as part of our ongoing oversight of the federal government’s COVID-19 response and recovery efforts.

Closing 


We are sending copies of this report to the appropriate congressional committees, the Office of Management and Budget, and other relevant agencies. In addition, the report is available at no charge on the GAO website at https://www.gao.gov .

If you or your staff have any questions about this report, please contact me at (202) 512-5500 or dodarog@gao.gov. Questions can also be directed to Kate Siggerud, Chief Operating Officer, at (202) 512-5600; A. Nicole Clowers, Managing Director, Health Care, at (202) 512-7114 or clowersa@gao.gov; or Orice Williams Brown, Managing Director, Congressional Relations, at (202) 512-4400 or williamso@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report.

Gene L. Dodaro

Comptroller General of the United States

Congressional Addressees

The Honorable Patrick Leahy
Chairman
The Honorable Richard Shelby
Vice Chairman
Committee on Appropriations
United States Senate

The Honorable Ron Wyden
Chairman
The Honorable Mike Crapo
Ranking Member
Committee on Finance
United States Senate

The Honorable Patty Murray
Chair
The Honorable Richard Burr
Ranking Member
Committee on Health, Education, Labor, and Pensions
United States Senate

The Honorable Gary C. Peters
Chair
The Honorable Rob Portman
Ranking Member
Committee on Homeland Security and Governmental Affairs
United States Senate

The Honorable Rosa L. DeLauro
Chairwoman
The Honorable Kay Granger
Ranking Member
Committee on Appropriations
House of Representatives

The Honorable Frank Pallone, Jr.
Chair
The Honorable Cathy McMorris Rodgers
Republican Leader
Committee on Energy and Commerce
House of Representatives

The Honorable Bennie G. Thompson
Chair
The Honorable John Katko
Ranking Member
Committee on Homeland Security
House of Representatives

The Honorable Carolyn B. Maloney
Chairwoman
The Honorable James Comer
Ranking Member
Committee on Oversight and Reform
House of Representatives

The Honorable Richard Neal
Chair
The Honorable Kevin Brady
Republican Leader
Committee on Ways and Means
House of Representatives

Appendixes and Enclosures 


IN THIS SECTION


Appendix I: Enclosures

Health Care Indicators

The federal government’s communication of data and COVID-19 indicators to the public and stakeholders could be improved.

Entity involved: Department of Health and Human Services

Recommendation for Executive Action

The Secretary of Health and Human Services should make the Department’s different sources of publicly available COVID-19 data accessible from a centralized location on the internet. This could improve the federal government’s communication with the public about the ongoing pandemic.

The Department of Health and Human Services neither agreed nor disagreed with our recommendation, but it agreed that COVID-19 data should be made accessible to support communication with the public about the pandemic.

Key Considerations and Future GAO Work

In January 2021, we reported on the need for more complete and consistent COVID-19 data to inform health care indicators. As we previously reported, the lack of complete and consistent data limits the Department of Health and Human Services’ (HHS) and others’ ability to monitor trends in the burden of the pandemic across states and regions, such as COVID-19 cases and hospitalizations; make informed comparisons between such areas; and assess the impact of public health actions to prevent and mitigate the spread of COVID-19. Additionally, 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.

We recommended that HHS immediately establish an expert committee comprised of knowledgeable health care professionals from the public and private sectors, academia, and nonprofits to systematically review and inform the alignment of ongoing data collection and reporting standards for key health indicators. HHS agreed with our recommendation but said because of resource constraints and the ongoing response to the pandemic, it could not commit to immediately doing so. We plan to continue to monitor HHS’s progress in meeting this recommendation.

In addition to our January 2021 report, throughout this report and our other past bimonthly reports, we have identified continued concerns with federal COVID-19 data. For example, in this report we identified concerns with the quality of federal data related to
  • COVID-19 cases, deaths, and vaccinations in nursing homes—see our Nursing Homes enclosure; and
  • race and ethnicity for several COVID-19 health indicators, including testing, cases, hospitalizations, deaths, and vaccinations—see our Health Disparities enclosure.

Background

The rapid spread and evolving nature of the COVID-19 pandemic have underscored the importance of effectively communicating information about the current status of the pandemic with the public on a regular basis. In June 2020, we reported that, in the midst of a nationwide public health emergency, clear and consistent communication between the federal government and the public is critical given that effective response requires the public’s participation and that the lack of such communication can lead to a loss of credibility with the public.

Further, effectively communicating information about the incidence, spread, and containment of an outbreak can help ensure that the public complies with public health measures. For example, in our 2011 report on the H1N1 influenza pandemic, we found that uncoordinated communication between the federal government and the public contributed to confusion and in some cases, individuals’ failure to seek or receive public health interventions, such as influenza vaccinations.

The federal government has provided the public and other stakeholders with data on COVID-19 health indicators. For example, HHS has published data on COVID-19 cases, deaths, testing, hospitalizations, and vaccines on the Centers for Disease Control and Prevention’s (CDC) COVID Data Tracker. [48] Additionally, the Data Strategy and Execution Workgroup (under the White House COVID-19 Response Team) has published COVID-19 Community Profile Reports in another online location and the reports focus on trends in COVID-19 indicators in the last 7 days and changes relative to the week prior. [49] CDC also provides access to these reports through a web link on its COVID Data Tracker.

The COVID-19 Community Profile Reports also highlight selected “hotspot” areas that have a high case burden and thus have a potentially higher risk for experiencing health care resource limitations. For example, the March 10, 2021 Community Profile Report stated that in the last 7 days the Miami, Florida area reported 254 COVID-19 cases per 100,000 persons and a test positivity rate of 9.8 percent. [50] In comparison, in the last 7 days, the national rate of COVID-19 cases was 144 cases per 100,000 persons and the test positivity rate was 4.2 percent. In addition, Miami, Florida had a higher rate of confirmed COVID-19 hospital admissions (9 admissions per 100 beds) than the national rate of 5 admissions per 100 beds, in the last 7 days. [51] The report also noted some decreases from the previous week (e.g., the rate of confirmed COVID-19 hospital admissions decreased by 13 percent nationally and by 10 percent in Miami, Florida).

Additionally, on January 21, 2021, the White House released its National Strategy for the COVID-19 Response and Pandemic Preparedness (National Strategy) which states that the federal government will regularly communicate information to the public on the status of the pandemic through expert-led, science-based public briefings. On January 27, 2021, the federal government began regularly conducting these briefings which describe recent national trends in several COVID-19 indicators including cases, hospitalizations, and deaths.

Overview of Key Issues

All 10 of the National Academies experts we interviewed told us the federal government’s communication of COVID-19 health indicators to the public and stakeholders could be improved. Several of these experts highlighted the importance of the federal government making data on the allocation of vaccines available and ensuring the public and stakeholders are aware of, understand how to use, and are able to easily obtain the COVID-19 data most relevant to them. In addition, several experts also suggested the federal government improve the accessibility of the data by centralizing access to it.

Communicating data on populations receiving COVID-19 vaccinations. Several experts highlighted the importance of the federal government providing information about those receiving COVID-19 vaccinations to the public and stakeholders. Specifically, these experts suggested the federal government share data on the race and ethnicity of those being vaccinated, as well as other high-risk populations (e.g., such as those age 75 and older) to help ensure public confidence in the distribution of the vaccine.

Race and ethnicity. Several experts told us it was important to report information on the race and ethnicity of those being vaccinated to help ensure the vaccine is being equitably provided to different populations. In our November 2020 report, we found that racial and ethnic minority groups are disproportionately affected by the virus. Further, population immunity is not likely to be reached without high vaccination rates across all racial and ethnic groups.

On February 8, 2021, CDC began publishing data on the demographic characteristics of those who received vaccines on its COVID Data Tracker. Specifically, CDC is reporting data on the race and ethnicity, gender, and age of those vaccinated at the national level. However, the reporting of race and ethnicity is less complete compared to gender and age. For example, as of March 11, 2021, CDC found that reporting of race and ethnicity was 53.1 percent complete for recipients who received at least one dose while the same reporting on vaccine recipients’ age and gender were 92.0 percent and 91.1 percent complete, respectively. For further information on CDC data on the race and ethnicity of recipients of COVID-19 vaccinations, see our Health Disparities enclosure, which includes a recommendation for CDC to ensure the complete reporting of race and ethnicity information for recipients of COVID-19 vaccinations.

One expert suggested using community-level data on vaccination use and the social characteristics of communities to assess the equity of vaccine distribution. For example, the Social Vulnerability Index (SVI) is CDC’s index to measure the relative vulnerability of every county by ranking each on 15 social factors, including unemployment, minority status, and disability. [52] According to CDC, these data might be used to help emergency response and public health officials identify and plan support for communities most likely to need support with a public health emergency. Currently, CDC does not make available county-level data on vaccination use, but does provide access to SVI data on its COVID Data Tracker. [53] However, CDC officials stated that the agency plans to provide county-level data on vaccination use on its COVID Data Tracker in March 2021. [54]

Other high-risk populations. Several experts said that it is important to make available to the public vaccination data that corresponds to individuals at higher risk of infection, which includes health care personnel, residents of long-term care facilities (e.g., nursing homes), persons age 75 or older, essential workers, and others, according to CDC recommendations. [55] Data on who is being vaccinated would inform the public of whether the goal of vaccinating those at higher risk per CDC recommendations (such as those age 75 and older) is being met. (For information on the need for additional data related to COVID-19 vaccinations of nursing home residents and staff, see our Nursing Home enclosure, which includes a recommendation for CDC to collect data specific to the COVID-19 vaccination rates in nursing homes.)

Several of these experts told us sharing vaccination data on high-risk populations with the public is also important because it can help ensure public confidence in the distribution of the vaccine. However, it may be challenging to report on certain groups who are at higher risk of infection, such as health care personnel, as information about vaccine recipients’ occupations are not reported to CDC by vaccine providers.

Key considerations for communicating federal COVID-19 data. In addition to emphasizing the importance of consistently communicating COVID-19 information, several experts emphasized the importance of the federal government ensuring that the public and stakeholders are aware of, understand how to use, and are able to easily obtain the COVID-19 data that are most relevant to them. Some of these experts noted that, in general, the public may be more aware of non-federal sources of data on COVID-19 indicators (e.g., the COVID Tracking Project, Johns Hopkins) than sources from the federal government. [56] Experts explained that at the beginning of the pandemic, the public and other stakeholders may have turned to non-federal sources for COVID-19 data because these sources provided more data than the federal government. For example, Johns Hopkins began publishing data on COVID-19 in January 2020, while CDC officials told us that its COVID Data Tracker began publishing data in April 2020. Further, because of their greater familiarity with non-federal sources of data, the public and stakeholders may have continued to use them—even as the federal government has continued to expand the COVID-19 data that it makes available to the public, including as part of CDC’s COVID Data Tracker and the Community Profile Report. For example, some of the experts told us they continue to use other non-federal sources of COVID-19 data and also that they were unaware of the Community Profile Reports.

Several experts also told us that it is important that the federal government help the public and stakeholders understand how to use its COVID-19 data. This could be done by explaining how to interpret community-level COVID-19 data it makes available, for example, to help inform the decisions of the public and other stakeholders (e.g. business owners deciding whether to open). For example, while CDC makes data available on case numbers for the variants of the virus that cause COVID-19, one expert told us that CDC does not explain how to interpret these numbers nor does the agency describe how stakeholders, including state and local public health officials, could use these data to inform their efforts to respond to the pandemic. [57] According to this expert, this information is important because different variants could increase the number of COVID-19 cases and deaths and reduce health care systems’ ability to care for patients. Our 2014 work on health care transparency states that tools for sharing health care information such as websites are most effective if they explain the purpose and value of the data reported to guide users in their interpretation of the data.

Several experts also commented on the importance of the federal government ensuring that users can readily obtain information that is most relevant to them, such as information about the status of the pandemic in their local area. For example, some of these experts stated that it is important to give users the ability to “drill down” to the level of data they need. Further, one expert stated that the federal government should allow data users to create a customized report that includes COVID-19 data that are of most relevance to them. Our 2014 work on health care transparency states that tools for sharing health care information such as websites are most effective if the information is structured in a way that enables users to obtain information that they consider most relevant to their personal circumstances (e.g., information about their communities) and if they allow users to easily adjust how those data are presented.

CDC has taken steps to ensure the public and stakeholders are aware of, understand how to use, and can easily obtain the COVID-19 data most relevant to them. For example:
  • On February 5, 2021, CDC published a communications tool kit for its COVID Data Tracker that, according to CDC, is updated weekly and includes social media graphics, videos, and media resources. CDC officials also told us that CDC shares information about its COVID Data Tracker on multiple social media platforms, including by promoting enhancements to the Data Tracker and featuring five COVID Data Tracker posts a week.
  • On February 12, 2021, CDC launched the COVID Data Tracker Weekly Review. According to CDC officials, this newsletter highlights key data from the COVID Data Tracker along with data trends, narrative interpretations of the data, and visualizations from the week. [58] As an example, the February 19, 2021 Weekly Review featured information about the variants of the virus that cause COVID-19, including the number of variants that are of concern to global public health leaders to date, and how to stop new variants of the virus from emerging.
  • CDC’s COVID Data Tracker provides tools to help users obtain the data most relevant to them. This includes the COVID-19 Integrated County View, which allows users to simultaneously view multiple types of information about the status of the pandemic in their county. As of February 22, 2021, county-level data across several COVID-19 indicators (e.g., cases, deaths, hospitalizations) were available from CDC’s COVID-19 Integrated County View tool.

Centralizing access to federal COVID-19 data. As part of its efforts to communicate with the public and stakeholders about the pandemic, several experts suggested that the federal government should improve the accessibility of its COVID-19 data by making these data available from a central location on the internet. CDC officials told us they were unaware of a single location on the internet where the public and stakeholders could access all of HHS’s COVID-19 data.

Further, in our review of selected HHS websites and COVID-19 data elements we found examples in which HHS published data for COVID-19 health indicators across several locations but did not make all the data accessible from a central online location (e.g., through website links). For example, we visited CDC’s COVID Data Tracker on March 12, 2021, and were unable to identify and access other publicly available HHS COVID-19 data from that website. While CDC’s COVID Data Tracker provided access to data on cases, testing, deaths, hospitalizations, and vaccinations, among other data, it did not provide users access to other HHS COVID-19 data such as higher-than-expected deaths and vaccine adverse events. That is, these data were not available on the COVID Data Tracker or accessible through links to the other websites where these data were located.

Several experts told us that taking steps to make it easier for members of the public to locate data on COVID-19 indicators, such as by making them accessible from one website, would help facilitate the use of those data by the public. These experts told us it is important to make data on COVID-19 health indicators more accessible because the information may help inform individuals’ decision-making. For example, one expert cited the importance of communicating data on vaccine adverse events in promoting public confidence in the vaccines. In our November 2020 report on COVID-19 vaccines and therapeutics development, we noted that timely, clear, and consistent communication about vaccine availability, efficacy, and safety can help ensure public confidence and trust, which in turn could encourage vaccine use.

As part of its Outbreak Communication Planning Guide, the World Health Organization highlights the importance of ensuring information is accessible to the public. Specifically, this guide states that information needed by at-risk parties to adopt behaviors that could minimize risk must be proactively released by authorities in a timely and accessible manner. The guide further states that information relevant to decisions and decision-making associated with the management of a serious public health event should be made available to interested parties so as to maintain trust in authorities, public support for control efforts and coordination among partners.

The National Strategy emphasizes the importance of the federal government ensuring its data for COVID-19 health indicators are accessible to the public and stakeholders. It states CDC will maintain public dashboard data on key COVID-19 related metrics and the federal government will ensure that Americans can simply and easily find information relevant to them on everything from testing, vaccines, testimonials, and all available public health guidance. Further, an executive order signed on January 21, 2021, directs federal agencies, including HHS, to take steps to make federal COVID-19 data publicly available and accessible. [59] The order states these efforts will assist federal, state, Tribal, territorial, and local authorities and further the public’s understanding of the pandemic and the response.

CDC officials told us that CDC’s COVID Data Tracker will serve as the public dashboard as stated in the National Strategy and that they coordinate with other HHS agencies by providing COVID-19 data through the COVID Data Tracker. However, CDC officials emphasized that each HHS agency is responsible for making its own COVID-19 data more accessible to the public and stakeholders and were unaware of other coordinated efforts at HHS to do so. The absence of a centralized online location for publicly accessible HHS COVID-19 data is reflective of how HHS agencies generally communicate other data to the public and other stakeholders; that is, they generally report data that they collect for their own purposes on separate agency-specific websites. Without a centralized online location in which individuals can identify and access all publicly available HHS COVID-19 data and easily obtain the information most relevant to them, the public, including stakeholders, may not be able to fully understand the extent of the pandemic and use the data to best inform their decision-making.

Agency Comments

We provided HHS and the Office of Management and Budget with a draft of this enclosure. HHS provided general comments, which are reproduced in appendix VI . In its comments, HHS neither agreed nor disagreed with our recommendation to make its different sources of publicly available COVID-19 data accessible from a centralized location on the internet. HHS officials agreed that data should be made publicly accessible where possible to support communication with the public about the COVID-19 pandemic. They also stated that increased transparency of data remains a key priority and indicated that HHS will continue to assess opportunities to streamline and provide transparency to the public and other government stakeholders. Given the importance of effectively communicating information about the status of the pandemic with the public, we maintain that HHS should make its publicly available COVID-19 data accessible from a centralized online location. Centralizing access to these data in a way that allows individuals to easily locate and obtain the information most relevant to them would improve the ability of the public to fully understand the extent of the pandemic and use the data to best inform their ongoing decision-making.

HHS also provided technical comments, which we incorporated as appropriate. The Office of Management and Budget did not provide comments on this enclosure.

Methodology

To conduct this work, we obtained input from 10 experts with knowledge in public health, health systems, and health economics in January 2021. [60] We obtained assistance from the National Academies in identifying these experts to better ensure a breadth of expertise was brought to bear in its preparation; however, all final decisions on the selection of experts for this work are the sole responsibility of GAO. We asked these experts a core set of questions to obtain their input on federal efforts to communicate COVID-19 health indicators. In addition, we reviewed relevant HHS documents and also obtained input from CDC officials about communicating COVID-19 health indicators to the public.

Contact information: Jessica Farb, 202-512-7114, farbj@gao.gov

Related GAO Products

Influenza Pandemic: Lessons from the H1N1 Pandemic Should Be Incorporated into Future Planning. GAO-11-632 . Washington, D.C.: June 27, 2011.

COVID-19: Federal Efforts Accelerate Vaccine and Therapeutic Development, but More Transparency Needed on Emergency Use Authorizations. GAO-21-207 . Washington, D.C.: November 17, 2020.

Health Care Transparency: Actions Needed to Improve Cost and Quality Information to Consumers, GAO-15-11 . Washington, D.C.: October 20, 2014.

Economic Indicators

Since the onset of the COVID-19 pandemic, mandated public health-related restrictions on economic activity, precautions by consumers, and adjustments by the private sector combined to create an extraordinary shock to the economy. In response, the federal government adopted a range of measures designed to support different areas of the economy, including labor markets, households, small business finances, corporate credit markets, and state and local government finances. These areas of the economy have recovered to greatly varying degrees over the last year (see table). Going forward, the strength of the economic recovery will continue to depend on the success of public health measures against the COVID-19 pandemic.

As of February 2021, indicators for some areas of the economy supported by the federal pandemic response had returned to pre-pandemic levels while other areas remained far from their pre-pandemic conditions. [61] Improvements in bond market indicators, for example, suggest that corporate borrowers and state and local governments had access to credit that was somewhat improved compared to before the pandemic. In contrast, the share of the population employed remained significantly below pre-pandemic levels, and the share of borrowers seriously delinquent on mortgage payments remained well above pre-pandemic levels. Moreover, our analysis of job losses and small business delinquencies identified sectors hard hit by the pandemic that have yet to fully recover, in particular the leisure and hospitality and mining and logging sectors.

Indicators for Areas of the Economy Supported by the Federal COVID-19 Pandemic Response, November 2020 through February 2021, Cumulative Changes since February 2020

aThe employment-to-population ratio represents the number of employed people as a percentage of the civilian noninstitutional population 16 years and over. The ratio is subject to misclassification errors with respect to consistently identifying workers as employed and absent from work or unemployed on temporary layoff.
bHigher levels in the Consumer Credit Default Composite Index rate indicate more defaults on consumer loans, including auto loans, bank cards, and mortgages. The Consumer Credit Default Composite Index could be subject to seasonal variation but is not seasonally adjusted.
cSeriously delinquent loans are 3 months or more past due or in foreclosure, based on mortgages insured by the Federal Housing Administration (FHA). Increases in serious delinquency rates on FHA loans could to some extent reflect borrowers taking advantage of mortgage forbearance provisions of the CARES Act, but may also indicate financial challenges facing the minority and low-to-moderate income households that disproportionately take out mortgages insured by FHA.
dLower levels of the small business credit card delinquency index indicate more delayed payments on credit. The small business credit card delinquency index is published under license and with permission from Dun & Bradstreet, and no commercial use can be made of these data.
eCorporate bond spreads are option-adjusted spreads on dollar-denominated investment grade corporate bonds from Bloomberg and are measured in basis points or 1/100th of a percentage point. Higher spreads reflect higher perceived risk among corporate borrowers by investors.
fSpreads on municipal bonds are calculated relative to interest rates on Treasury securities based on the Bloomberg-Barclays Municipal Bond Index and are measured in basis points or 1/100th of a percentage point. Higher spreads reflect higher perceived risk among municipal borrowers by investors.
gState and local government employment data from January 2021 and February 2021 are preliminary.
hHealth care employment data from January 2021 and February 2021 are preliminary.

The national economy experienced a substantial contraction in the second quarter of 2020 but grew in the third and fourth quarters of 2020 based on the growth of Gross Domestic Product (GDP). The Federal Reserve Bank of New York’s Weekly Economic Index, which combines high-frequency economic data from a wide range of sources, also indicated a substantial contraction in March and April 2020, followed by a gradual recovery (see figure). [62] However, both GDP and the Weekly Economic Index suggest that, as of February 2021, the economic recovery has slowed and that the economy is smaller than it was a year ago.

Weekly Economic Index, January 2019 through February 2021

Note: The index value of the Weekly Economic Index corresponds to a year-over-year growth rate in gross domestic product were conditions to remain at that value for a full quarter.

As we noted in our June 2020 report, the impact of the COVID-19 pandemic on the economy will reduce federal tax revenues, while the fiscal response from the COVID-19 relief laws and heightened demands on federal social programs will increase expenditures. [63] Federal debt held by the public increased from $17.4 trillion in February 2020 to $21.8 trillion in February 2021. As a share of GDP, debt held by the public increased from 79.0 percent in the fourth quarter of 2019 to 100.7 percent in the fourth quarter of 2020. Interest rates on 3-month Treasury securities were 1.54 percent in February 2020 and fell to 0.14 percent in April 2020 as the Federal Reserve reduced its target interest rates. As of February 2021, 3-month interest rates were 0.04 percent. [64] While interest rates on Treasury securities are low at the moment, reducing the cost of newly issued debt, the long-term fiscal challenges facing the U.S. have been exacerbated by the pandemic and will require attention once the economy has returned to consistent growth and public health goals have been attained. [65]

Labor market conditions. In February 2021, the employment-to-population ratio, which measures the share of the population employed, was 3.5 percentage points lower than in February 2020, suggesting that labor market conditions remain worse than in the pre-pandemic period. The pandemic has affected some sectors of the economy much more than others. In particular, industries like leisure and hospitality and mining and logging have seen the largest percentage losses in employment during the pandemic (see figure). Importantly, individuals working in the leisure and hospitality sector historically have had the lowest average earnings among sectors and, moreover, during the pandemic have seen the most significant job losses, indicating that many low wage workers remained out of work as of February 2021.

Percentage Change in Employment by Sector, February 2020 through February 2021

Note: Other services include repair and maintenance, personal and laundry services, and membership associations and organizations. Data from February 2021 are preliminary.

Moreover, labor market conditions have weakened more for Hispanic, Black, and Asian Americans relative to White Americans since the pandemic began (see figure). In recent months, the number of initial claims for unemployment benefits have remained historically high, indicating ongoing instability in the labor market.

Change in Employment-to-Population Ratio by Race and Ethnicity, February 2020 through February 2021

Household financial conditions. While trends in consumer credit defaults suggest an overall improvement in household financial conditions over the last year, trends in mortgage delinquencies suggest ongoing financial challenges facing some households. Specifically, as of January 2021 the Consumer Credit Default Composite Index—a broad measure of households’ ability to make scheduled payments—improved somewhat over the course of the pandemic. In addition, subindexes for bank cards, first mortgages, and auto loans improved during the same time period. [66] Although changes in these indexes over time should provide a general indication of changes in the financial condition of households, forbearance arrangements could affect the measurement of consumer credit defaults. [67]

In contrast to measured consumer credit defaults, serious delinquency rates for single family mortgage loans—loans that are 90 or more days past due or in foreclosure—increased dramatically in May 2020, decreased slightly in more recent months, but remain much higher than in February 2020, as of January 2021 (see figure).

Serious Delinquency Rates on Single-Family Residential Mortgages, January 2019 through January 2021

Note: The serious delinquency rate on conventional loans is calculated based on a weighted average of serious delinquency rates of conventional loans guaranteed by Fannie Mae and Freddie Mac based on loan counts as of October 2020. Single-family seriously delinquent loans are 3 months or more past due or in the foreclosure process.

Increases in delinquencies to some extent reflect borrowers taking advantage of mortgage forbearance provisions of the CARES Act but may also indicate financial challenges facing households that may not be captured by indicators of default. Moreover, while serious delinquency rates on conventional loans, specifically those guaranteed by Fannie Mae and Freddie Mac, improved slightly in recent months, delinquency rates on loans insured by the Federal Housing Administration (FHA) still remain at near historically high levels. Increases in delinquency rates on FHA loans in particular could indicate that minority and low-to-moderate income households have experienced more financial hardship since the onset of the pandemic as FHA loans disproportionately serve minority and low-to-moderate income borrowers. [68]

Small business financial and credit conditions. Trends in the Small Business Health Index over the last year suggests that some aspects of the financial condition of small business have returned to pre-pandemic levels. However, small businesses also have earned less income and experienced significantly greater difficulty accessing credit than before the pandemic. In addition, small businesses in some sectors continue to make late payments on credit cards. [69]

The small business credit card delinquency index—a measure from Dun & Bradstreet of the timeliness of credit payments of small businesses—weakened for 3 consecutive months beginning in April 2020, but since then has returned to pre-pandemic levels. While the overall ability of small businesses to make timely payments on credit cards improved compared to February 2020, small businesses in some sectors, for example retail and mining and logging, had more late payment compared to pre-pandemic levels (see figure). In addition, small business income—measured by non-farm proprietors’ income from the Bureau of Economic Analysis—has been increasing gradually since June 2020 but as of January 2021 remained lower than in February 2020. [70]

Changes in the Small Business Credit Card Delinquency Index by Sector, February 2020 through January 2021

Note: Other services include repair and maintenance, personal and laundry services, and membership associations and organizations. The small business credit card delinquency index is published under license and with permission from Dun & Bradstreet, and no commercial use can be made of these data.

While some aspects of the financial condition of small businesses have improved compared with a year ago, more banks have tightened rather than loosened underwriting standards on the credit they have extended to small businesses for 4 consecutive quarters, beginning the first quarter of 2020, according to data collected by the Federal Reserve. [71] In addition, more banks have been raising rather than lowering the interest premiums they have charged on loans to small businesses over the same period. These changes indicate that banks anticipated greater risk associated with making these loans going forward.

Corporate credit market conditions. Trends in corporate bond market risk over the last year suggest that perceived risk among investment grade corporate borrowers and access to credit for investment grade corporations have returned to pre-pandemic levels. Specifically, spreads on investment grade corporate bonds increased dramatically starting in early March 2020, then fell rapidly starting in late March 2020 (see figure), and since August of 2020 have returned to levels that were typical during the past few years, prior to the pandemic. [72]

Spreads on Investment Grade Corporate Bonds, January 2019 through February 2021

Note: Corporate bond spreads are measured in basis points or 1/100th of a percentage point.

State and local government finances. State and local government fiscal conditions deteriorated significantly in the spring of 2020 as the national economy weakened and most states delayed income tax filing deadlines. Since this initial shock, total state and local government tax revenues and access to credit via municipal bond markets have significantly improved. In the aggregate, state and local government expenditures remained steady during the pandemic while state and local government employment is substantially lower than before the pandemic.

Based on Census Bureau data, tax revenue collected by state and local governments rose by $130 billion, on a seasonally adjusted basis, in the third quarter of 2020 after falling by over $69 billion in the second quarter (see figure). [73] With the increase in the third quarter revenues, over the first three quarters of 2020 state and local tax revenues were similar to the same period in 2019. Future tax revenues to state and local governments are likely to be sensitive to the strength of the economic recovery.

State and Local Government Tax Revenue, First Quarter 2019 through Third Quarter 2020

Note: State and local tax revenues are seasonally adjusted.

Spreads on municipal bonds increased dramatically in March 2020, peaking on March 23, and decreased gradually over the last year. [74] As of February 2021, municipal bond spreads were somewhat lower than their level as of February 2020, suggesting that perceived risk among municipal borrowers and access to credit for state and local governments were somewhat improved compared to pre-pandemic levels. In contrast, state and local government employment, another timely indicator of state and local fiscal conditions, fell dramatically in the spring of 2020 and remains 1.4 million below levels in February 2020 as of February 2021 (see figure). In the aggregate, state and local government expenditures remained steady during the pandemic, reflecting higher spending on social benefit payments but lower spending in other areas. [75]

State and Local Government Employment, January 2019 through February 2021

Agency Comments

We provided the Department of Housing and Urban Development (HUD), the Department of Labor (Labor), the Department of Treasury (Treasury), the Board of Governors of the Federal Reserve System (Federal Reserve), the Federal Housing Finance Agency (FHFA), the Office of Management and Budget (OMB), and the Small Business Administration (SBA) with a draft of this enclosure. Labor and Treasury provided technical comments, which we incorporated as appropriate. HUD, the Federal Reserve, FHFA, OMB, and SBA did not provide comments on this enclosure.

Methodology

To identify indicators for monitoring areas of the economy supported by the federal response to the COVID-19 pandemic, in particular by the six COVID-19 relief laws, we reviewed prior GAO work, data from federal statistical agencies, data from Fannie Mae and Freddie Mac, information from the Federal Reserve and relevant federal agencies responsible for the pandemic response and oversight of the health care system, data available on the Bloomberg Terminal, and input from internal GAO experts. We reviewed the most recent data from these sources as of January or February 2021, depending on availability.

We assessed the reliability of the economic indicators we used through a number of steps, including reviewing relevant documentation, reviewing prior GAO work, and interviewing data providers. Collectively, we determined the indicators were sufficiently reliable to provide a general sense of how the areas of the economy supported by the federal pandemic response were performing.

Contact information: Lawrance L. Evans, Jr., (202) 512-8678, evansl@gao.gov

Relief for Health Care Providers

The Department of Health and Human Services has not finalized and implemented a post-payment review process to validate claims for the HRSA COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured (COVID-19 Uninsured Program). As of March 1, 2021, it had disbursed a total of about $120 billion (about 67 percent) of the $178 billion appropriated by COVID-19 relief laws for the Provider Relief Fund to help support health care providers and finance care for COVID-19 patients and underserved populations. The department also lent about $106.5 billion to health care providers through a program expanded by the CARES Act.

Entities involved: Department of Health and Human Services, including its Centers for Medicare & Medicaid Services and Health Resources and Services Administration

Recommendation for Executive Action

The Secretary of Health and Human Services should finalize and implement a post-payment review process to validate COVID-19 Uninsured Program claims and to help ensure timely identification of improper payments, including those resulting from potential fraudulent activity, and recovery of overpayments. HHS concurred with the recommendation and stated that it anticipates, among other things, finalizing the audit review strategy with contractor support to help ensure timely identification of improper payments and recovery of overpayments.

Key Considerations and Future GAO Work

As the Department of Health and Human Services (HHS) works to get funds to eligible providers, it will continue to be important that HHS officials remain attentive to establishing robust internal controls to help ensure funds are appropriately disbursed and used. We plan to conduct additional work to examine HHS’s efforts to provide assistance to providers.

Background

Provider Relief Fund. To respond to the pandemic, three of the five COVID-19 relief laws enacted as of March 1, 2021, appropriated $178 billion to reimburse eligible providers for health-care-related expenses or lost revenues attributable to COVID-19, known as the Provider Relief Fund. Specifically, the CARES Act appropriated $100 billion, the Paycheck Protection Program and Health Care Enhancement Act appropriated $75 billion, and the Consolidated Appropriations Act, 2021, appropriated $3 billion for this purpose. [76] The Health Resources and Services Administration (HRSA), within HHS, administers payments from the Provider Relief Fund, including allocations to the COVID-19 Uninsured Program.

Accelerated and Advance Payments Program. HHS’s Centers for Medicare & Medicaid Services’ (CMS) Accelerated and Advance Payments Program provides loans to providers and suppliers when there is a disruption in claims submission or processing, including during a public health emergency or a presidentially declared disaster. [77] Section 3719 of the CARES Act authorized the expansion of this program due to the COVID-19 pandemic. Under the expanded program, active Medicare providers and suppliers could apply for loans of up to 100 percent or 125 percent of the Medicare payments they received for a prior 3-month or 6-month period, depending on the type of provider or supplier. On April 26, 2020, CMS announced that provider applications for the Advance Payments Program were discontinued in light of grant payments made available for similar purposes through the Provider Relief Fund. As of October 8, 2020, CMS stopped accepting applications for accelerated or advance payments as they relate to the COVID-19 Public Health Emergency, although CMS will continue to monitor the ongoing impacts of COVID-19 on the Medicare provider and supplier community.

Overview of Key Issues

Provider Relief Fund. As of March 1, 2021, HHS had allocated about $154 billion from the Provider Relief Fund, with about $24 billion not yet allocated. [78] Of the total $154 billion allocated, about $120 billion had been disbursed and about $34 billion was yet to be disbursed. According to HHS officials, the agency allocated about $77 billion for general relief for health care providers and about $57 billion for targeted areas. See table below for a summary of Provider Relief Fund allocations and disbursements.
Summary of the Provider Relief Fund ($178 billion) Allocations and Disbursements, as of March 1, 2021

Description

Allocation
($ billions)

Date of initial disbursement

Disbursement
($ billions)

General distributions

Phase I: Medicare

46.016

April 10, 2020

41.971

Phase II: Medicaid and Children’s Health

Insurance Program (CHIP) providers

4.067

July 3, 2020

3.143

Phase II: dental providers

1.290

July 28, 2020

0.978

Phase III: assisted living facilities

0.627

September 25, 2020

0.299

Phase III: general distribution

24.500

November 14, 2020

14.393

Subtotal of general distributions

76.500

60.784

Targeted distributions

Rural health care facilities

11.092

May 6, 2020

10.963

High-impact hospitals

20.750

May 7, 2020

20.668

Skilled nursing facilities

5.000

May 22, 2020

4.761

Indian health care providers

0.520

May 29, 2020

0.509

Safety net hospitals

13.074

June 12, 2020

12.907

Children’s hospitals

1.063

August 20, 2020

1.062

Nursing home infection control, quality, and performance

5.000

August 27, 2020

4.405

Subtotal of targeted distributions

56.499

55.275

Subtotal of general and targeted distributions

132.999

116.059

Other

Treatment and testing of the
uninsured/vaccine administration

10.000

May 15, 2020

2.165

Vaccine and therapeutic development

and procurement activities

9.970

November 25, 2020

1.664

Administration

0.980

n/a

0.036

Unallocated fundsa

24.051

n/a

0.000

Total

178.000

119.924
Legend: n/a = not applicable
Source: Summary of Health and Human Services funding data. | GAO-21-387

aHealth Resources and Services Administration (HRSA) officials told us that the amount of unallocated funds/uninsured treatment/vaccine administration is available for treatment of the COVID-19 Uninsured Program and for other Provider Relief Fund allocations.

Summary of fund disbursements. As of March 1, 2021, about $120 billion of the approximately $154 billion allocated from the Provider Relief Fund had been disbursed. The amount disbursed was less than the amount allocated because some of the disbursements were in progress and some of the funds were returned. HRSA officials told us that the returned funds are reflected in the above table. According to our analysis of information provided by HRSA, as of March 1, 2021, HHS had disbursed about $61 billion from general distribution allocations and about $55 billion from the targeted allocations.

From April 10, 2020, the date of the initial disbursement, to May 31, 2020, about $65 billion was disbursed. Funds were disbursed at a slower pace in the subsequent nine months through March 1, 2021. An additional $9.5 billion was disbursed during those months at an average monthly disbursement of $4.8 billion. HRSA officials told us that this slowdown reflected in part the fact that funds allocated through the General Distribution during that time required providers to submit applications that HRSA reviewed.

Payments returned to Provider Relief Fund. According to HRSA, providers had declined about $8 billion from previous disbursements as of February 26, 2021. HRSA officials told us that those funds are available for subsequent allocations. [79] According to our analysis of information provided by HRSA, 74 percent of the returned funds were from general distributions and 26 percent are from targeted distributions. About $4.4 billion was returned to HRSA after being disbursed as part of the first general allocation, Phase 1–Medicare. This amount is approximately 73 percent of all returned funds. About $1.2 billion was returned after being disbursed as part of the targeted allocation for High-Impact Hospitals. This amount is approximately 19 percent of all returned funds. Some providers returned funds because they were not needed. For example, a large health system headquartered in California returned all but one small disbursement, including funds from the Medicare, High-Impact, Skilled Nursing, and Nursing Home Infection Control allocations totaling to about $771 million. The health system stated in a press release that it was able to return the majority of funds due to actions taken to manage expenses.

COVID-19 treatment of uninsured. The Provider Relief Fund includes an allocation for the COVID-19 Uninsured Program, although the total amount to be used for this program has not yet been determined by HHS officials. [80] As of March 1, 2021, approximately $2.2 billion from the Provider Relief Fund had been disbursed for COVID-19 treatment, testing, and vaccine administration of uninsured individuals. As of March 1, 2021, over 25 million claims have been paid. HRSA officials reported that future disbursements for this purpose will come out of the approximately $24 billion remaining in unallocated funds in the Provider Relief Fund.

Providers who choose to participate in this program must attest to its terms and conditions, which include that the individual treated, tested, or administered a vaccine is uninsured, the provider will accept reimbursement as payment in full, and the provider will not bill the individual for the balance of the bill. Reimbursement is generally available at Medicare rates for treating uninsured individuals with a COVID-19 diagnosis as well as the testing and administration of a licensed or authorized COVID-19 vaccine to uninsured individuals.

HRSA has not yet finalized and implemented a post-payment review process to validate COVID-19 Uninsured Program provider claims. HRSA’s risk assessment identified a risk that COVID-19 Uninsured Program providers may falsify patient rosters. [81] In response to this risk, HRSA stated that providers must attest services were rendered to an uninsured patient. Under the COVID-19 Uninsured Program terms and conditions, HRSA can recover overpayments made for instances of provider non-compliance. HRSA intends to perform post-payment reviews of claims to validate certain provider attestations, according to agency officials. However, HRSA did not have documentation describing how it plans to conduct these reviews, such as review plans, standard operating procedures, or staff manuals, and the factors and criteria to be used for selecting and assessing the validity of selected provider claims.

Agency officials stated that the agency has been focused on prepayment processes and launching the Provider Relief Fund reporting portal. According to HRSA officials, the agency is working with a contractor to develop and recommend a post-payment audit strategy with phased implementation to begin in late calendar year 2021. Although we acknowledge that in emergency situations, such as the COVID-19 pandemic, agencies must implement programs and disburse certain relief funds quickly, strong internal controls help ensure that relief funds are used for only authorized purposes. Additionally, it is important for agencies to recover overpayments as quickly as possible.

Federal internal control standards state that management should design control activities to achieve objectives and respond to risks and implement control activities through policies. [82] As part of these standards, management designs specific actions to respond to the analyzed program risks on a timely basis, including the potential for fraud, and clearly documents internal controls in a manner that allows the documentation to be readily available for examination.

Without documented post-payment review policies and procedures and timely implementation of related control activities, HRSA’s ability to consistently identify and recover improper payments, including those resulting from potential fraudulent activity, will be limited. As a result, for those payments identified as an overpayment, HRSA’s efforts to recover them will be delayed, if they are recovered at all.

Single Audit Requirements. The Single Audit Act establishes requirements for states, the District of Columbia, local governments, U.S. territories, tribal governments, and nonprofit organizations that receive federal awards to undergo single audits of those awards annually (unless a specific exception applies), when their expenditures of the award meet a certain dollar threshold. [83] In its single audit implementing regulations, HHS further requires commercial (for-profit) organizations that meet a certain dollar threshold to undergo: (1) an audit in conformance with single audit requirements or (2) a financial related audit of the applicable award(s) in accordance with Generally Accepted Government Auditing Standards. [84] These audits are critical to helping to identify deficiencies in the award recipient’s compliance with applicable provisions of laws, regulations, contracts, or grant agreements and in its financial management and internal control systems. Correcting such deficiencies can help ensure the appropriate use of federal funds and reduce the likelihood of federal improper payments.

Auditors who conduct single audits follow guidance in the Office of Management and Budget’s (OMB) Compliance Supplement and agency guidance (e.g., FAQs) specific to their programs. The Provider Relief Fund reimburses health care providers for health-care-related expenses or lost revenues attributable to COVID-19. An auditor’s review of such reported health care expenditures and lost revenues may be a critical component of a Provider Relief Fund recipient’s single audit. [85]

Per the December 2020 Compliance Supplement Addendum, Provider Relief Fund expenditures (including lost revenues) will first be reported in the Schedule of Expenditures of Federal Awards (SEFA) and audited under OMB’s single audit guidance in fiscal years ending on or after December 31, 2020. However, for those entities with fiscal years ending on or after June 30, 2021, SEFA reporting guidance will be in the 2021 Compliance Supplement. As we previously reported, delays in issuing guidance could adversely affect auditors and the results and timing of their work, and may lead to inconsistent reporting. (See Single Audit enclosure for recommendation to OMB.)

Accelerated and Advance Payments Program. Under the expanded Accelerated and Advance Payments Program, amended by the CARES Act, CMS made accelerated and advance payments totaling about $107.3 billion as of January 12, 2021. Initially, recoupment of the accelerated and advance payments, through the offsetting of new Medicare claims, was to begin not more than 120 days after the funds were disbursed. Thus, recoupment was scheduled to begin in late July 2020.

However, the Continuing Appropriations Act, 2021 included a provision that delayed repayment until 1 year after the accelerated or advance payment was made, with recoupment of Medicare payments owed to providers beginning at 25 percent for the first 11 months, and at 50 percent for the following 6 months. [86] Accordingly, the provision allows 29 months from the date of the first payment to a provider or a supplier before requiring that the outstanding balance be paid in full. As of January 12, 2021, providers had voluntarily repaid about $8.4 billion and the outstanding loan balance in the Accelerated and Advance Payments Program was about $98.9 billion.

Agency Comments

We provided HHS and OMB with the draft of this enclosure. HHS provided technical comments on this enclosure, which we incorporated as appropriate. HHS provided written comments, reproduced in Appendix VI and technical comments, which we incorporated as appropriate. OMB did not provide any comments on this enclosure.

HHS agreed with our recommendation to finalize and implement a post-payment review process. As part of implementing this process, HHS stated that it will, with contractor support, finalize the audit review, pilot and test the post-payment audit review process, and validate COVID-19 Uninsured Program claims to help ensure timely identification of improper payments and recovery of overpayments. We urge HHS to implement this post-payment review process as expeditiously as possible.

Methodology

To conduct our work, we examined publicly released HHS information, federal laws and regulations, OMB’s single audit guidance, and obtained information from CMS and HRSA in the form of written responses to questions, documents, and datasets. Our review of the data sources provides reasonable assurance of the data’s reliability. The Provider Relief Fund dataset came from HRSA, which is the only available source for the disbursement data. The allocation amounts and categories that were provided by HRSA match publicly available information.

Contact information: Carolyn L. Yocom, (202) 512-7114, yocomc@gao.gov

Nursing Homes

After peaking in December 2020, rates of new COVID-19 cases and deaths in nursing homes have declined; however, additional data related to COVID-19 vaccinations in nursing homes is needed. Staffing in nursing homes also continues to be a concern.

Entities involved: Centers for Disease Control and Prevention and Centers for Medicare & Medicaid Services, both within the Department of Health and Human Services.

Recommendations for Executive Action

The Secretary of Health and Human Services should ensure that the Director of the Centers for Disease Control and Prevention collects data specific to the COVID-19 vaccination rates in nursing homes and makes these data publicly available to better ensure transparency and that the necessary information is available to improve ongoing and future vaccination efforts for nursing home residents and staff. HHS neither agreed nor disagreed with this recommendation.

The Secretary of Health and Human Services should ensure that the Administrator of the Centers for Medicare & Medicaid Services, in consultation with the Centers for Disease Control and Prevention, requires nursing homes to offer COVID-19 vaccinations to residents and staff and design and implement associated quality measures. HHS neither agreed nor disagreed with this recommendation.

Key Considerations and Future GAO Work

We have previously made two recommendations related to COVID-19 outbreaks in nursing homes:
  • In September 2020, we recommended that the Secretary of Health and Human Services, in consultation with the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC), develop a strategy to capture more complete data on confirmed COVID-19 cases and deaths in nursing homes retroactively back to January 1, 2020, and clarify the extent to which nursing homes had reported data before May 8, 2020.

    Although the Department of Health and Human Services (HHS) partially agreed with this recommendation, as of February 2021, this recommendation had not been implemented.
  • In November 2020, we recommended that the Administrator of CMS quickly develop a plan that further detailed how the agency intended to respond to and implement, as appropriate, the 27 recommendations in the final report of the Coronavirus Commission on Safety and Quality in Nursing Homes, which CMS released on September 16, 2020. [87]

    HHS neither agreed nor disagreed with our recommendation; instead, it highlighted actions that CMS has taken related to Commission recommendations and indicated that it would refer to and act upon the Commission’s recommendations as appropriate. As of February 2021, CMS had no additional updates.

We maintain the importance of our recommendations. Specifically, we maintain that collecting data on COVID-19 cases and deaths from nursing homes retroactively would better inform the government’s continued response and recovery, and we maintain that HHS could ease the burden by incorporating data previously reported to CDC or to state or local public health offices. Additionally, we maintain that developing a plan for whether and how CMS will proceed with the Commission’s recommendations would improve the agency’s ability to systematically consider the Commission’s recommendations going forward.

In this enclosure, we note additional concerns particularly around the availability of nursing home vaccination data. Further, we have ongoing work on the oversight of infection prevention and control and emergency preparedness in nursing homes.

Background

The health and safety of the 1.4 million elderly or disabled residents in the nation’s more than 15,000 Medicare- and Medicaid-certified nursing homes—who are often in frail health and living in close proximity to one another—has been a particular concern during the COVID-19 pandemic. [88] CMS, an agency within HHS, is responsible for ensuring that nursing homes meet federal quality standards to participate in the Medicare and Medicaid programs. To monitor compliance with these standards, CMS enters into agreements with state survey agencies within each state to conduct inspections, including recurring comprehensive standard surveys and as-needed investigations.

The CARES Act appropriated $100 million for this oversight, and it directed CMS to prioritize the use of funds for nursing home facilities in localities with community transmission of COVID-19. [89] According to CMS, of this amount, the agency plans to provide state survey agencies approximately $81 million through September 30, 2023, to be used to ensure that all nursing homes receive targeted infection control surveys, among other things. [90] CMS has set aside the remaining $19 million to enhance survey system technology, to fund PPE for federal surveyors, and to implement improvements recommended by the Nursing Home Commission, according to the agency. [91]

In addition, HHS announced in May 2020 that it would contribute $4.9 billion from the Provider Relief Fund, established with funds provided under COVID-19 relief laws to reimburse eligible providers for health care-related expenses or lost revenues attributable to COVID-19, as direct payments to assist nursing homes with responding to COVID-19. [92] In July, HHS announced that it would provide an additional $5 billion from the fund. HHS later announced that $2.25 billion from the fund would be dedicated to establishing an incentive-based program—the Quality Incentive Payment Program—to reward nursing homes that create and maintain safe environments for their residents. Payments would be made to nursing homes for their efforts to reduce COVID-19 infection and mortality rates among residents, based on CDC data. According to HHS, as of March 1, 2021, it awarded approximately $1.9 billion in four rounds.

In response to the pandemic, HHS, primarily through CMS and CDC, has taken a range of actions to address infection prevention and control in nursing homes, which we reported on in our previous reports from June, September, and November 2020 and January 2021. One recent action in October 2020 was to establish the Pharmacy Partnership for Long-Term Care Program, an agreement with pharmacy partners to conduct COVID-19 vaccination clinics for residents and staff of long-term care facilities, including nursing homes, to minimize the burden on facilities and jurisdictional health departments. [93]

Overview of Key Issues

COVID-19 cases and deaths in nursing homes. According to CDC case-reporting data, as of February 7, 2021, more than 99 percent of Medicare- and Medicaid-certified U.S. nursing homes had reported at least one confirmed resident or staff case, and more than 80 percent had reported at least one resident or staff COVID-19 death. [94] New weekly confirmed cases of COVID-19 in nursing homes fluctuated but generally remained under 12,000 new cases until late 2020 when weekly cases increased considerably reaching over 25,000. (See figure.) Specifically, new weekly resident cases peaked the week ending December 20, 2020, at more than 33,600 resident cases—178 percent higher than the previous peak for the week ending July 26, 2020. New weekly staff cases peaked one week prior with over 28,600 staff cases for the week ending December 13, 2020—141 percent higher than the week ending July 26, 2020. Since then cases have again been declining. [95]

New weekly resident deaths also saw an increase in late November, eventually reaching a new peak of 6,019 for the week ending December 20, 2020—about 72 percent higher than the previous peak the week ending May 31, 2020. Combined nursing home resident and staff deaths from COVID-19, as a percentage of total COVID-19 deaths in the U.S., remained largely unchanged throughout this time period (consistently making up about 30 percent of all COVID-19 deaths in the U.S.). The changing weekly COVID-19 death counts in nursing homes generally paralleled changes in the country as a whole.

New Weekly Confirmed COVID-19 Cases and Deaths among U.S. Nursing Home Residents and Staff, as Reported by Medicare- and Medicaid-Certified Nursing Homes, Weeks Ending May 31, 2020, through February 7, 2021

Notes: Dates refer to the end of a week (e.g., May 31 refers to the entire week from May 25 through May 31).
According to CDC, data used in this analysis are part of a live data set, meaning that facilities can make corrections to the data at any time. Data presented in this enclosure reflect the data downloaded as of February 18, 2021, which includes data through the week ending February 7, 2021. We excluded data for the week ending May 24, 2020, because it is the first week for which data are available from the Centers for Disease Control and Prevention (CDC) and could include cases and deaths from multiple weeks dating back to January 1, 2020.
Weekly and cumulative case and death counts are likely underreported because they do not include data for the nursing homes that did not report COVID-19 data to CDC for that week or from nursing homes that submitted data that failed data quality assurance checks. Additionally, as we previously reported, the Centers for Medicare & Medicaid Services (CMS) does not require nursing homes to report data prior to May 2020, although nursing homes may do so voluntarily. We recommended that the Secretary of Health and Human Services—in consultation with CMS and CDC—develop a strategy to capture more complete data on confirmed COVID-19 cases and deaths in nursing homes retroactively to January 1, 2020.
Weekly staff deaths reported for the weeks ending May 31, 2020, through February 7, 2021, ranged from 13 (week ending September 20) to 61 (week ending May 31).

Vaccination clinics for nursing home residents and staff offered through the pharmacy partnership near completion. The first vaccinations were administered to nursing home residents beginning in mid-December 2020, and CDC announced that the first round of on-site vaccine clinics, conducted through the Pharmacy Partnership for Long-Term Care Program, were completed in 99 percent of nursing homes by late January. The pharmacy partnership program, announced in October 2020, was responsible for much of the administration of vaccinations in nursing homes, as well as in other long-term care facilities. (See table below for a timeline of key dates.)
Key Dates in Roll Out of Vaccinations for Nursing Homes

Date

Milestone

October 2020
  • October 16: Pharmacy Partnership for Long-Term Care Program announced by HHS
    • Agreement with CVS, Walgreens, and Managed Health Care Associates to provide and administer COVID-19 vaccines to residents of long-term care facilities, including nursing homes
    • Manages the COVID-19 vaccination process, including storage, administration, and reporting, to minimize the burden on facilities and jurisdictional health departmentsa

December 2020
  • December 1: CDC’s Advisory Committee on Immunization Practices recommended prioritizing nursing home residents for vaccinations, in addition to health care personnel and other residents of long-term care facilities
  • December 3: CDC Director accepted the advisory committee’s recommendation for priority groups for the initial phase of the COVID-19 vaccination program
  • December 11: Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech vaccine
  • December 18: Food and Drug Administration authorized the emergency use of the Moderna vaccine
  • December 18: First vaccine doses were administered to nursing home residents and staff members in two trial states—Connecticut and Ohio
  • December 21: Vaccinations through the Pharmacy Partnership for Long-Term Care Program begin

January 2021
  • January 4: All 54 jurisdictions that elected to participate in the Pharmacy Partnership for Long-Term Care Program had started the vaccination process
  • January 25: 99 percent of nursing homes participating in the Pharmacy Partnership for Long-Term Care Program completed their first clinics by the end of the week

February 2021
  • Early February: Continued third, and final, on-site vaccination clinics at nursing homes participating in the Pharmacy Partnership for Long-Term Care Program
Source: GAO analysis of information from the Department of Health and Human Services. | GAO-21-387

aThere are 64 jurisdictions which include all U.S. states and territories and some local health programs.

According to CDC and nursing home association officials, the Pharmacy Partnership for Long-Term Care Program is making progress towards its intended goals, specifically its goal to vaccinate the long-term care populations, including nursing home residents. According to CDC, the pharmacy partnership aimed to complete first vaccination clinics within 4 weeks of starting clinics in a jurisdiction. [96] Vaccination clinics began the week of December 21, 2020, and CDC reports that, as of January 25, 2021, first vaccination clinics were completed in 99 percent of nursing homes. Additionally, the nursing home associations we interviewed were pleased that nursing homes were prioritized and acknowledged that vaccinating the entire nursing home population was a massive undertaking that was generally successful.

Another goal of the partnership was to reduce the burden on facility staff. The two nursing home associations we interviewed indicated satisfaction with the pharmacy partnership on this goal as well. Officials from one of the associations noted that the burden on their member facilities was lessened by having the pharmacy partnership responsible for some of the administrative tasks associated with administering the vaccines.

According to nursing home association and state and local health department officials, the Pharmacy Partnership for Long-Term Care Program faced some challenges during the initial launch of the program. Key challenges have included a shift from federal to state control of the program, resident vaccination consent issues, and staff members’ reluctance to be vaccinated, among others. [97]
  • Decentralization of the Pharmacy Partnership for Long-Term Care. The two nursing home associations we interviewed said that some of the difficulties implementing the partnership program stemmed from the fact that the program is a state-controlled program, though it was originally designed to be a federal program. The federal government entered into agreements with the pharmacy partners and required facilities to sign up to participate in the partnership. However, each state is responsible for activating the partnership and allocating doses from the state’s overall allocation from the federal government. [98] Thus, vaccinations by the pharmacy partners cannot begin until the state activates the agreement and allocates doses to the pharmacy partners. According to state and nursing home association officials, this resulted in more than 50 different plans for implementation, which caused confusion among jurisdictions’ health departments, nursing homes, and pharmacy partners and hampered communication and vaccine education efforts. The officials said a more centralized distribution model may have created a more efficient approach to vaccinating the nursing home population.
  • Obtaining resident consent. The state and nursing home association officials noted confusion and difficulties obtaining consent from nursing home residents and their families to administer the vaccine, indicating that pharmacy partners in some cases wanted to gather written consent from residents before administering the vaccines. According to the CDC, written consent is not required by federal law for COVID-19 vaccination, but pharmacy partners that are administering the vaccine in long-term care facilities have the discretion to require verbal, email, or written consent from recipients. [99] Initial attempts to gather written consent may have delayed the start of vaccination clinics at some locations, though association officials said that once the pharmacies accepted informed consent, this was no longer an issue.
  • Staff reluctance to be vaccinated. The state and nursing home association officials indicated that, while vaccine take-up rates among residents were high, take-up rates for staff vaccinations were much lower, making it difficult for facilities to predict how many vaccine doses were needed. [100] The officials attributed staff reluctance to be vaccinated to several factors, including the challenge of convincing people to be the first to take a quickly developed vaccine, underlying issues of government mistrust, myths spread on social media, and the initial lack of information resources on vaccine safety. CDC responded to concerns about vaccination hesitancy by increasing the availability of materials to better inform and empower health care providers, including a communications toolkit with messages and strategies to combat hesitancy.

Detailed data for nursing home resident and staff vaccinations is not publicly reported , making it difficult to monitor ongoing vaccination efforts and nursing home quality. According to CDC, approximately 4.25 million vaccine doses were administered to residents and staff in nursing homes through the Pharmacy Partnership for Long-Term Care Program, as of February 11, 2021—79 percent of all doses administered through the partnership. [101] See table below. According to detailed data that we obtained from CDC, as of February 11, 2021, the program has completed 13,433 first vaccination clinics, 11,975 second vaccination clinics, and 2,340 third vaccination clinics in nursing homes. [102]
COVID-19 Vaccinations Conducted in Nursing Homes through the Pharmacy Partnership for Long-Term Care Program by Recipient Type, as of February 11, 2021

Recipient

Number receiving a first dose

Number receiving a second dose

Residents

1,788,470

712,646

Staff members

1,251,087

497,276

Total

3,039,557

1,209,922
Source: GAO analysis of information from the Centers for Disease Control and Prevention. | GAO-21-387

CDC does not have complete data on vaccines administered to residents and staff members of nursing homes outside of the Pharmacy Partnership for Long-Term Care Program, so it does not have insight into vaccination rates for individual nursing homes that chose not to participate in the program or for states that opted out of the program. [103] For example, while West Virginia—the only state that opted not to participate in the program—completed its first round of nursing home vaccination clinics before the end of December 2020, administration information for long-term care facilities was not reported to CDC. [104] As a result, these data are not included in CDC tracking data on nursing home vaccinations. [105] According to CDC officials, data on vaccines administered to residents and staff members of nursing homes that did not enroll in the federal program can be voluntarily reported by the facilities through the National Healthcare Safety Network, but it is unclear how many of those that are reporting are receiving vaccinations outside of the pharmacy partnership. [106]

Further, while CDC collects data on the number of vaccinations administered to nursing home residents and staff through the Pharmacy Partnership for Long-Term Care Program, it does not publicly report this information for nursing homes specifically. Instead, CDC reports the number of vaccination doses, by state, provided to residents and staff of all long-term care facilities vaccinated through the pharmacy partnership, which includes other types of long-term care providers. [107] According to CDC, it is not reporting nursing home specific data because of concerns it would not accurately reflect the vaccination rates in nursing homes due to turnover within facilities. For example, some residents may have received only a second dose through the pharmacy partnership, as they may have received the first dose prior to being admitted into the nursing home. However, any considerations for interpreting the data could be noted when presenting the data publicly and does not negate the value of reporting information on the number of first and second doses administered to both staff and residents at the state level for nursing homes for tracking purposes.

With nursing homes having long been an epicenter of the COVID-19 pandemic, and with CDC’s Advisory Committee on Immunization Practices recommending that residents be among the first to be vaccinated, detailed information on vaccinations for this population—similar to what is provided for long term-care facilities overall—is important for tracking and transparency. The National Strategy for the COVID-19 Response and Pandemic Preparedness notes that agencies should be sharing data on COVID-19 response and recovery efforts and that these data should be publicly available to support performance tracking and ensure transparency. Without publicly providing detailed vaccination data that shows vaccination rates for the different long-term care facilities, including nursing homes, it is unclear how successful efforts have been to vaccinate nursing home residents and may make it difficult to use these data to improve ongoing and future vaccination efforts for the nursing home population.

Further, data on COVID-19 vaccinations in nursing homes will also be important for CMS’s ongoing efforts to monitor nursing home quality. In January 2021, CMS had not specified whether nursing homes would be required to offer COVID-19 vaccinations or how these vaccinations would be incorporated into its requirements or quality measures for nursing homes. CMS also had not provided a time frame for making these decisions. The agency said that it continues to evaluate when and whether changes regarding the COVID-19 vaccine need to be incorporated into its infection control requirements for nursing homes. It also noted that it is collaborating with CDC to develop quality measures for COVID-19 vaccinations for appropriate staff and patients.

Vaccination data are a key part of CMS’s oversight of nursing home infection prevention and control practices—practices critical for managing outbreaks such as COVID-19. Since 2005, CMS has required nursing homes to offer influenza and pneumococcal vaccinations to nursing home residents, given the risk of complications, hospitalizations, and death caused by influenza and pneumococcal disease, particularly among the elderly. [108] These vaccination rates are publicly reported as part of CMS’s Nursing Home Quality Initiative and provide information on the potential risk of influenza and pneumococcal outbreaks in facilities. Furthermore, making this data transparent through public reporting provides consumers with insight into how well nursing homes are caring for their residents' physical and clinical needs, and we have previously reported (October 2014) that timely information on provider quality are characteristics of effective transparency tools.

COVID-19 has a mortality rate far exceeding that of influenza and, according to CDC, spreads more easily than influenza, making it a significant threat to nursing home residents. Like data on influenza and pneumococcal vaccination rates, data on COVID-19 vaccination rates could help manage the risk of COVID-19 outbreaks in nursing homes and serve as an important source of information for consumers about quality of care, making the collection of complete vaccination rate data critical for any quality measures developed.

Staffing challenges continue. The percentage of nursing homes experiencing staffing shortages improved slightly from when we reported in January. [109] According to data nursing homes self-reported to CDC, as of February 7, 2021, approximately
  • 17 percent of nursing homes had a shortage of aides (a decrease of about 3 percentage points),
  • 16 percent had a shortage of nursing staff (a decrease of about 2 percentage points),
  • 9 percent had a shortage of other staff (a decrease of about 2 percentage points), and
  • 2 percent had a shortage of clinical staff (a decrease of less than 1 percentage point). [110]

Nursing home association officials we interviewed noted that the workforce situation has not improved since we reported in January. These association officials said that staff in nursing homes are exhausted, face burn out from emotional trauma, may be required to quarantine due to exposure to the virus, or must stay home to take care of family members who become sick, all of which may further strain resources. [111] According to one nursing home association we interviewed, the employment of temporary nurse aides has been an important tool to avoid larger staffing shortages, reinforcing information we heard and reported on earlier in the pandemic. During the public health emergency, nursing homes have relied on nurse aides hired or retained under a CMS flexibility that waived or reduced certain training and certification requirements for nurse aides to allow nursing homes greater flexibility to address staffing shortages during the pandemic. [112]

Agency Comments

We provided HHS and the Office of Management and Budget (OMB) with a draft of this enclosure. HHS provided general comments, which are reproduced in Appendix VI . In its comments, HHS neither agreed nor disagreed with our recommendations.

In response to our recommendation to collect and publicly report COVID-19 vaccination data for nursing homes, HHS said it is working towards better data transparency and noted that nursing homes have an opportunity to voluntarily report data through the National Healthcare Safety Network tracking system. However, our focus was on reporting data that is already collected through the Pharmacy Partnership for Long-Term Care and was provided to us for this report. Specifically, HHS should publicly report the first and second dose data for residents and staff of nursing homes—as it does for long-term care facilities on the whole—when the pharmacy partnership ends in order to provide insight into how successful the pharmacy partnership was in vaccinating nursing home residents and staff.

In response to our recommendation to require nursing homes to offer COVID-19 vaccinations to residents and staff and to design and implement associated quality measures, HHS said it agrees that access to vaccines is essential for nursing home residents. The department indicated that CMS is “actively evaluating” whether changes need to be made to its infection control requirements regarding the COVID-19 vaccine and that CMS and CDC “have made progress in developing quality measures related to COVID-19 vaccination.” We maintain the importance of these recommendations for providing insight into nursing home quality of care and protecting the vulnerable nursing home population.

HHS also provided technical comments, which we incorporated as appropriate. OMB did not have comments on this enclosure.

Methodology

To conduct this work, we reviewed CMS and CDC data, agency guidance, and other relevant information on HHS’s response to the COVID-19 pandemic. We also reviewed written responses from CMS and CDC and spoke to CMS and CDC officials. In addition, we interviewed representatives from two national nursing home associations and officials from associations representing various state and local officials.

In addition, we analyzed CDC data on COVID-19 reported by nursing homes for the week ending February 7, 2021. [113] We analyzed the CDC data as they were reported by nursing homes to CDC and publicly posted by CMS.

We did not otherwise independently verify the accuracy of the information with these nursing homes. We assessed the reliability of the data sets used in our analyses by checking for missing values and obvious errors and reviewing relevant CMS and CDC documents. We determined the data were sufficiently reliable for the purposes of our reporting objective.

Contact information: John E. Dicken, (202) 512-7114, dickenj@gao.gov

Related GAO Products

Infection Control Deficiencies Were Widespread and Persistent in Nursing Homes Prior to COVID-19 Pandemic. GAO-20-576R . Washington, D.C.: May 20, 2020.

Science & Tech Spotlight: COVID-19 Testing. GAO-20-584SP . Washington, D.C.: May 20, 2020.

Nursing Homes: Better Oversight Needed to Protect Residents from Abuse. GAO-20-259T . Washington, D.C.: November 14, 2019.

Health Care Transparency: Actions Needed to Improve Cost and Quality Information for Consumers, GAO-15-11 . Washington, D.C.: October 20, 2014.

Strategic National Stockpile and the Medical Supply Chain

While the Office of Assistant Secretary for Preparedness and Response has taken some steps to address immediate supply needs, the COVID-19 pandemic has highlighted long-standing challenges related to the Strategic National Stockpile’s role and capabilities; these will take time to address.

Entities involved: The Office of the Assistant Secretary for Preparedness and Response, within the Department of Health and Human Services.

Key Considerations and Future GAO Work

Over the course of our CARES Act work, we have reported on efforts to modernize and restructure the Strategic National Stockpile (SNS) including progress towards building a 90-day supply of certain key items to respond to future surges in COVID-19 cases, as well as federal and state efforts to address medical supply gaps. We made recommendations in our September and January reports.

In September 2020, we recommended that the Department of Health and Human Services (HHS), in coordination with the Federal Emergency Management Agency (FEMA) within the Department of Homeland Security, develop and communicate to stakeholders plans outlining specific federal government actions that will be taken to help mitigate supply gaps for the remainder of the COVID-19 pandemic, which could contribute to ensuring a more effective response. [114] HHS and the Department of Homeland Security disagreed with this recommendation.

In January 2021, we reported on HHS’s draft strategy to improve the medical supply chain to enhance pandemic preparedness by monitoring supply information, increasing domestic production, and re-thinking supply management. [115] We recommended that HHS develop a process for regularly engaging with Congress and nonfederal stakeholders as the agency refines and implements its supply chain strategy, to include the role of the SNS. HHS generally agreed with this recommendation.

We will continue to monitor federal actions to mitigate supply gaps through federal planning and SNS modernization efforts, as well as progress toward SNS 90-day inventory goals, in response to provisions in the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 and the CARES Act. [116]

Background

The SNS, overseen by HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR), is a federal stockpile of vaccines, pharmaceuticals, and medical supplies and devices designed to be deployed to support the response to a public health emergency. [117] At the outset of the COVID-19 pandemic, the SNS was a critical resource to states for needed and scarce medical supplies. However, the nationwide need for personal protective equipment (PPE) to protect responders and to treat Americans sickened with COVID-19 quickly exceeded quantities contained in the SNS.

On January 31, 2020 the Secretary of Health and Human Services declared a public health emergency and began to take actions to respond to the pandemic including distributing medical supplies through the SNS to states, localities, territories, and tribes beginning in March 2020. The U.S. Government COVID-19 Response Plan (PanCAP Adapted) identifies HHS as the lead federal agency for the COVID-19 response, with support from FEMA for coordination. [118] However, in March 2020, leadership for the overall response shifted to FEMA, including responsibility for the acquisition and distribution of supplies in conjunction with HHS. [119]

As of March 11, 2021, six relief laws had been enacted to assist the COVID-19 response. [120] These laws appropriated funding for HHS activities, and, in some cases, specifically authorized their use for the SNS. As of February 28, 2021, HHS reported it obligated about $8.9 billion of the $13.9 billion it planned to use for the SNS to purchase PPE and ventilators for immediate use as well as to replenish SNS inventory, among other purposes, and had expended about $5.2 billion.

Overview of Key Issues

Pandemic highlighted long-standing challenges related to SNS role and capabilities. The COVID-19 pandemic has been unprecedented in scale and has stressed the resources and capabilities of federal, state, and local governments, as well as the private and non-profit sectors. Over the course of the past year, as part of our CARES Act reports, we have discussed the SNS and its role in the pandemic response with officials from federal and state governments, public health associations, and experts on public health preparedness. From these interviews, a consistent set of long standing challenges emerged regarding the role, funding, and supply allocation of the SNS as well as challenges related to federal response coordination.

Determining the appropriate role of the SNS in a pandemic. The near depletion of the SNS early in the pandemic response raised questions among the state officials and experts we interviewed about the role, expectations and transparency of the SNS during a nationwide pandemic. For example, all eight states we interviewed in July and August 2020 reported that certain supplies they received from the SNS were not sufficient to meet their needs and most added that the SNS should be more transparent in the future about its contents to set realistic expectations about the availability of supplies.

ASPR officials, however, told us that the SNS was not designed to provide states with supplies for a prolonged nationwide event such as the COVID-19 pandemic; it is primarily designed to respond to discrete and localized events. The SNS was originally created to provide for the emergency health security of the United States in the event of a bioterrorist attack or other public health emergency. [121] Over time the SNS has been used to respond to a growing variety of threats including radiological and nuclear, influenza and other emerging infectious diseases, and natural disasters. In its fiscal year 2018-2022 budget plan for medical countermeasure development, HHS noted that building an inventory of supplies to address all types of threats has been a challenge.

Additionally, several of the experts we interviewed noted that a re-examination of the role of the SNS during a pandemic is needed so that there is clarity about what resources and capabilities would be made available to state, local, tribal, and territorial governments from the stockpile.

HHS has been discussing the proper role of the SNS for many years. For example, in 2016, HHS convened a National Academy of Sciences workshop to, among other things, reevaluate the SNS’s emphasis on potential chemical, biological, radiological, and nuclear attacks on the United States. [122] Participants noted that the role of the SNS was already broad and intended to support all types of hazardous events. As one participant noted, without better focus the SNS would not be able to fulfill the greatest amount of life saving potential.

Aligning SNS role and funding. Several of the experts we interviewed mentioned that it is important to ensure that SNS funding is adequate and flexible enough to match its role. The issue of aligning the SNS’s role with its funding was highlighted during the COVID-19 response as officials from all states and most public health associations we interviewed noted that certain types of PPE from the SNS were not sufficient in terms of quantity, and in some cases, quality. For example, one state and most public health associations reported that some supplies, such as masks, distributed by the SNS were past their expiration dates and could not be used.

ASPR officials told us that HHS did not replenish PPE to previous levels following the H1N1 influenza pandemic of 2009. According to an HHS budget document, in April 2009, at the start of the H1N1 pandemic, the SNS contained approximately 106 million N95 respirators. In December 2019, prior to the start of the COVID-19 pandemic, the SNS contained 12.6 million N95 respirators, which were remaining from the H1N1 pandemic. As of January 27, 2021, the federal response has supplied about 100 million N95 respirators to state, tribal, and territorial governments in response to COVID-19, according to federal data provided in a senior leadership brief.

ASPR officials told us that HHS did not replenish PPE to previous levels following the H1N1 influenza pandemic of 2009 because of a lack of funding. ASPR officials noted that requested funding has not always fully reflected SNS funding needs. They explained that this is because there are competing priorities and tradeoffs and the budget process involves aligning SNS budgetary needs with broader HHS needs and the President’s budget priorities.

Funding concerns were also identified in a 2013 working group report compiled by two HHS advisory bodies. [123] The working group concluded that the SNS was increasingly confronted with unfunded requirements as its responsibilities expanded and, without action, anticipated a widening gap between the responsibilities of the SNS and the resources available to fulfill them.

Allocating scarce SNS supplies. Some experts and all public health association officials told us that it was challenging to understand how the SNS allocated scarce medical supplies. For example, one expert—a state public health official—noted that it was difficult to understand what supplies were being sent out of the SNS and how they were being allocated, and all states noted that they did not receive the quantity of supplies requested.

As we reported in our June 2020 CARES Act report, ASPR officials told us they distributed SNS supplies to states in March and April 2020 primarily using a pro-rata allocation strategy, which provided supplies to every state based on population. [124] ASPR officials noted that this approach was used to distribute materials to states in previous public health emergencies, including the H1N1 influenza pandemic of 2009 when the SNS distributed 85 million N95 respirators, among other supplies. Given the finite amount of supplies contained in the SNS and the widespread demand, ASPR officials told us that this allocation strategy was the most equitable approach.

We also reported that HHS and FEMA officials believed that states may have requested more supplies than they needed. ASPR officials added that many of the processes the SNS and the states had put into place for supply request and distribution were not applicable to a nationwide response where the volume of supplies was not adequate. ASPR officials told us that another allocation approach—directing supplies to the areas of greatest need—was simply not an option at the beginning of the COVID-19 response due to the lack of reliable data and modeling uncertainty needed to target supplies. As such, they determined that pro-rata allocation was a reasonable approach for distributing the finite amount of supplies contained in the SNS at the start of the pandemic.

While the SNS had never faced a response of this scale or duration prior to the COVID-19 pandemic, ASPR has attempted to understand what supply allocation models might be appropriate in a large scale event. For example, the 2016 Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) Strategy and Implementation Plan noted that PHEMCE was working to identify approaches to address medical countermeasure resource allocation when stockpile inventory was inadequate to meet the needs of a large-scale public health emergency. [125] ASPR officials were unable to recall or provide further information specific to this effort, but noted certain actions taken around determining the allocation of medical countermeasures and vaccines for an anthrax event. ASPR officials added that resource allocation approaches have been part of the planning discussions for influenza or other emerging infectious diseases for many years.

Clarifying roles and responsibilities among response partners. States, experts, and public health association officials noted challenges with requesting supplies when the responsibility shifted from HHS to FEMA in March 2020. For example, one expert noted that supply request confusion was compounded by the fact that states had processes to request and receive supplies from the SNS, but during the response there were additional agencies involved in the process. We identified similar issues in our September 2020 CARES Act report and made recommendations about the need to document roles and responsibilities for supply management functions transitioning to HHS from other federal partners, such as the Department of Defense, and devising interim solutions to help states track supply requests and plan for supply needs.

HHS officials told us that they have had extensive coordination and communication with states during the response, including holding calls with state governors, delivering trainings, providing briefings, and disseminating guidance. HHS officials noted that improving the pandemic response capabilities, practices, processes, and capacity of state, local, tribal, and territorial governments is a priority. ASPR officials added that there is always some confusion and lack of clarity related to supplies during an emergency and they are always looking for ways to improve and refine.

After-action reports of actual events and pandemic exercises have also identified issues with federal coordination. For example:
  • FEMA’s initial assessment report of its COVID-19 response issued in January 2021 noted that not all response members understood who led the resource allocation mission and how it fit into the overall response. [126] The report noted that differences between FEMA and HHS component agencies, including ASPR, created significant issues with coordination and service delivery to state, local, tribal, and territorial partners.
  • The after-action report of a large-scale avian influenza pandemic exercise conducted in August 2019 (“Crimson Contagion”) noted confusion among exercise participants around the process for requesting supplies from multiple federal entities. [127] For example, the after-action report noted that the resource request process was not transparent to the range of state, local, tribal, territorial, and federal response partners.
  • Finally, coordination issues among multiple federal response partners were also noted in the Centers for Disease Control and Prevention’s after-action report for the 2014 Ebola response. That report noted that agencies and organizations were often unaware of the mission and responsibilities of other response partners and a deeper understanding of capabilities, roles, and responsibilities will likely be needed in the future.

Both the FEMA COVID-19 assessment and Crimson Contagion after-action report made recommendations about conducting training and exercises focused on how federal agencies coordinate and communicate with state, local, tribal and territorial partners. ASPR officials noted in February 2021 that they have not yet had a chance to address the recommendations in the Crimson Contagion after action report due to the pandemic response. ASPR officials told us that they are collecting data to inform their COVID-19 after-action report as the response is ongoing and will analyze the data and prepare the report after the response has ended.

ASPR has taken steps to help address immediate COVID-19 supply needs. In the short term, ASPR, in conjunction with its federal partners, determined a key action would be to stockpile a 90-day supply of certain PPE, which could help address the scarcity of these supplies for the immediate pandemic and could help address allocation issues by having adequate supply. According to HHS officials, this effort was funded with COVID-19 relief funds, such as those made available through the CARES Act.

According to ASPR officials they were aiming to meet their 90-day targets of PPE by the end of 2020; however, as we previously reported, ASPR has to balance replenishing the stockpile with ensuring adequate commercial availability. As such, ASPR officials reported that they have delayed delivery of some contracted items to the SNS to enable manufacturers to make them available in the commercial market to alleviate supply constraints. For example, ASPR contract information shows that the SNS deferred delivery of 10.1 million N95 respirators from October 2020 to April 2022. Additionally, HHS also reported distributing supplies from the stockpile to address immediate supply needs. Both of these activities may continue to affect progress towards 90-day targets; although ASPR officials noted in February 2021 that they were not planning any additional deferrals.

According to ASPR data, as of February 2021, the SNS has reached, or almost reached, its 90-day targets for N95 respirators, surgical or procedural masks, and eye protection or face shields. However, supplies of gloves and gowns or coveralls remain far from their 90-day targets. According to ASPR officials, ensuring adequate supplies of nitrile gloves continues to be a problem due to the issues with the global supply chain. See table below for more on the SNS inventory of PPE. (For more information on medical supply availability and efforts to expand domestic medical product manufacturing, please see our enclosures on Hospital and Pharmacy Perspectives on COVID-19 Vaccine Administration and Medical Supply Availability and Domestic Medical Product Manufacturing .
Strategic National Stockpile Personal Protective Equipment Inventory

Personal protective equipment

Feb. 26, 2021 inventory on hand

Planned 90-day Inventory

Gloves – surgical/exam

227 milliona

4.5 billion

N95 respirators

307 million

300 million

Surgical or procedural Masks

411 million

400 million

Gowns or coveralls

65.8 million

265 million

Eye protection or face shields

17.6 million

18 million
Source: Data from the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the Department of Health and Human Services. | GAO-21-387

Note: The SNS continues to deploy supplies in response to requests and these deployments may affect the ability to reach the SNS inventory targets and could also result in some fluctuation in inventory quantities over time, according to ASPR officials.
aAccording to ASPR officials, the SNS contains a mix of glove types in its inventory including latex, vinyl, nitrile, and a blend of vinyl and nitrile. Of these types, the vinyl-nitrile blend makes up most of the glove inventory.

Stockpiling for the near term could help address challenges the SNS had with the quality and quantity of supplies they were able to provide at the beginning of the COVID-19 response and allow for more targeted allocation strategies. However, ASPR officials were uncertain whether they would maintain these target supply levels beyond the COVID-19 response. Additionally, ASPR officials noted that they have limited ability to rotate expiring PPE stock but have requested the use of COVID-19 relief funds to replace depleted or expiring PPE.

ASPR has also taken steps to improve efficiency in the distribution of certain pandemic supplies through a vendor managed inventory approach. Under this approach, ASPR has contracted with vendors to hold and distribute products that the SNS has purchased in response to the COVID-19 pandemic. ASPR officials told us that this model has advantages in a pandemic since it utilizes multiple distribution centers that are geographically diverse and can deliver directly to points of care.

Plans to address longer-term challenges facing SNS will take time to address. Efforts to address longer-term challenges that we and others have identified—such as the role of the SNS in future pandemics, budget planning for that role, and sustainment of current PPE inventory—will take longer to address. ASPR officials told us these issues are tied to developing a broader supply chain capability that includes the ability to monitor the commercial supply chain for disruptions to it and supporting domestic manufacturing capabilities for PPE and other medical countermeasures. To that end, HHS developed a national supply chain strategy that outlines the capabilities that they must acquire—including, but not limited to, the SNS—to address the challenges identified by the pandemic. [128] The draft strategy discusses many of the longer-term challenges we raise above.

However, the federal government is in a period of transition when it comes to developing and implementing a longer-term supply chain strategy to address both the specific SNS challenges we and others identified and broader supply chain issues. ASPR officials told us in late January 2021 that their draft supply chain strategy was on hold as the agency examines how it aligns with the new administration’s priorities.

As we reported in January 2021, reexamining the role of the SNS in the U.S. response to pandemics will require difficult policy decisions and tradeoffs about systems, budgets, and authorities. Further, the COVID-19 pandemic has shown how complex and difficult a coordinated response across numerous federal and state, local, tribal, and territorial entities can be. Our prior work (see Related Product section for our 2004 work on national strategies, for example) and that of others has shown that implementing significant organizational change requires a comprehensive, integrated strategic plan with desirable characteristics that provide additional guidance to responsible parties for developing and implementing national strategies. Such a plan can set a clear direction for transformation efforts, help decision makers more effectively guide and assess progress, and do so in a clear and transparent manner. Additionally, such planning can provide the government with a sound basis for making investment decisions and help assure that it is developing and maintaining the optimal set of capabilities to achieve its transformational goals. ASPR officials stated that they remain committed to following stated guidance and best practices regarding strategic planning and implementation, consistent with previous ASPR efforts.

In January 2021, the President signed an Executive Order calling for the development of a pandemic supply chain resilience strategy to design, build, and sustain a long-term capability to manufacture medical supplies for future pandemics and biological threats. [129] Per the order, this strategy is to include the role of the SNS in (1) providing and allocating supplies across state, local, tribal and territorial governments, (2) sustaining supplies during a pandemic, and (3) contingency planning, among other things, within 180 days. Implementing the recommendation we made in January 2021 to develop a process for regularly engaging with Congress and nonfederal stakeholders in the development and implementation of a medical supply chain strategy to enhance pandemic response capabilities—to include the role of the SNS—would help guide this complex transformation.

To address more immediate supply needs, the President has also called for action that is consistent with our September 2020 recommendation that HHS—in coordination with FEMA—develop and communicate to stakeholders plans outlining specific federal government actions that will be taken to help mitigate supply gaps. Specifically, the Executive Order also directed the Secretaries of State, Defense, Health and Human Services, and Homeland Security among other federal agencies to immediately review the availability of pandemic response supplies, including PPE, and take appropriate action to fill any identified shortfalls in consultation with state, local, tribal, and territorial governments and other critical entities, as appropriate.

Additionally, the Consolidated Appropriations Act, 2021—enacted in December of 2020—included a provision requiring the President to make publicly available a report containing a whole-of-government plan for effective response to subsequent COVID-19 outbreaks and for future global pandemic diseases. [130] The act stipulates that this pandemic plan should address how to improve the role of the federal government with respect to the regulation, acquisition, and disbursement of medical supplies necessary to respond to COVID-19 as well as the procurement and distribution of PPE, among other things.

We will continue to monitor efforts to develop plans and strategies to address challenges raised by the COVID-19 pandemic regarding the SNS’s capabilities and other efforts to create resiliency in the medical supply chain, as part of our future CARES Act and SNS work.

Agency Comments

We provided HHS and the Office of Management and Budget (OMB) with a draft of this enclosure. HHS provided technical comments, which we incorporated as appropriate. OMB did not provide comments on this enclosure.

Methodology

To understand and categorize SNS COVID-19 challenges, we reviewed interviews we conducted and documents we received over the course of our CARES Act reporting. This included (1) interviews, written responses, and documentation from ASPR, FEMA, the Department of Defense and other interagency groups about actions related to increasing supply, making distribution decisions, and modernizing the SNS; (2) interviews with eight states (in July and August 2020) that were selected based on a variety of criteria including a range of COVID-19 case counts per capita, regional diversity, and participation in Crimson Contagion, among other things; (3) interviews with 9 individuals (in September, October, November, and December 2020) with expertise on the operations or activities of the SNS, and an understanding of public health funding, preparedness, and COVID-19 response actions (referred to as “experts” in this enclosure); and (4) interviews with public health, private industry, laboratory and health care associations throughout the course of our work. To understand ASPR efforts to address challenges, as well as current efforts to develop COVID-19 supply chain strategies, we held interviews with ASPR officials in the current and former administrations and reviewed executive orders related to pandemic response. Finally, to assess the reliability of the SNS inventory data reported in this enclosure, we discussed inventory controls with agency officials and conducted comparisons to other sources to check for consistency. We determined the data were sufficiently reliable for the purposes of our reporting objectives.

Contact information: Mary Denigan-Macauley, (202) 512-7114, deniganmacauleym@gao.gov

Related Product

Combating Terrorism: Evaluation of Selected Characteristics in National Strategies Related to Terrorism. GAO-04-408T . Washington, D.C.: February 3, 2004.

Funding for COVID-19 Testing

Selected jurisdictions told us that federal funding for testing has been generally sufficient for the short term, but concerns about longer-term sustainability remain.

Entities involved: Centers for Disease Control and Prevention, within the Department of Health and Human Services, and the Department of the Treasury

Key Considerations and Future GAO Work

We recently and repeatedly reported on concerns with the federal response to COVID-19 testing. For example:
  • In September 2020, we reported on challenges with testing supply availability, and recommended that HHS develop plans outlining specific actions the federal government could take to help mitigate remaining medical supply gaps—including testing supply shortages. As of January 2021, HHS disagreed with our recommendation, noting, among other things, the work that the department had done to manage the medical supply chain and increase supply availability. We acknowledge those efforts, but continue to maintain that our recommendations are warranted. For more information on the availability of testing supplies, see the Hospital and Pharmacy Perspectives on Administering Vaccines and Medical Supply Availability enclosure.
  • In November 2020, we reported on issues with the transparency of Centers for Disease Control and Prevention (CDC) testing guidelines and recommended that the Department of Health and Human Services (HHS) ensure that the scientific rationale for any changes is included when such changes are made. HHS concurred with our recommendation and has begun to implement it. For example, on February 16, 2021, CDC issued Interim Guidance on Testing Healthcare Personnel and provided links to studies that explained the scientific rationale for the changes in guidance. We will continue to monitor implementation of this recommendation to ensure that these efforts continue.

In January 2021, we reported on the HHS COVID-19 testing strategy at that time and recommended that HHS produce and make publicly available a consolidated and comprehensive national strategy document that incorporated all six characteristics of an effective national strategy. [131] The new administration issued its National Strategy for the COVID-19 Response and Pandemic Preparedness (National Strategy) on January 21, 2021 that includes increasing testing capacity among its seven goals. [132] To meet this goal, the National Strategy describes several actions, including the issuance of an Executive Order establishing the COVID-19 Pandemic Testing Board (Testing Board). The Testing Board is tasked with implementation of a clear, unified approach to testing and coordinating federal government efforts to promote COVID-19 testing, among other things. We will continue to monitor Testing Board efforts and the development of any comprehensive plans to implement testing goals outlined in the National Strategy.

The Paycheck Protection Program and Health Care Enhancement Act requires HHS to submit Testing Strategy reports to Congress every 90 days until funds provided under the act are expended. [133] As of March 16, 2021, HHS had not submitted the report due in February to Congress or released it to the public. HHS officials told us that they do not have plans to make the report public and will defer to Congress on whether they will share the report broadly. Until a comprehensive national testing strategy is publicly available, HHS is at risk of key stakeholders and the public lacking crucial information to support an informed and coordinated testing response.

Since we last reported in January, officials from eight states and one territory (hereafter referred to as jurisdictions) we interviewed in January 2021 reported that federal funding available for testing has been generally sufficient for the short run. While about 7 percent of the $30 billion in CDC funding awarded to states, localities, and territories for testing has been expended as of February 28, 2021, officials told us they prioritized spending down general use funds with a shorter period of availability before using money that is more specifically targeted for testing, provided through CDC, and available for longer periods. At the same time, these selected jurisdictions shared concerns about maintaining testing capacity and preparedness in the longer term. While recent funding appropriated after we interviewed jurisdictions will likely bolster response efforts for COVID-19 testing, it is too soon to know whether this new funding will meet longer term needs. We will continue to monitor the use of federal funding for testing.

Background

Diagnostic testing for COVID-19 is critical to controlling and understanding the spread of the virus, according to the CDC. As the coordinating agency for the federal response to public health and medical emergencies, HHS leads the development and implementation of the national COVID-19 testing strategy. Under the testing strategy from the previous administration, states managed their own COVID-19 testing programs with federal support.

According to the new administration’s National Strategy, issued on January 21, 2021, the federal government will partner with jurisdictional leaders to implement a cohesive response strategy that will include the goal of mitigating the spread of COVID-19 by expanding testing, among other things. [134] To meet this goal, the National Strategy describes several actions, including the issuance of an Executive Order establishing the Testing Board and directing agencies to facilitate testing free of charge for those who do not have insurance coverage.

Additionally, the Consolidated Appropriations Act, 2021, requires the President to make publicly available a report containing a whole-of-government plan for an effective response to subsequent major outbreaks of COVID-19 by late March 2021. [135]

Overall, HHS reported total obligations of about $42.9 billion as of February 28, 2021 with expenditures of about $8.5 billion, for testing-related activities. [136] About $35.5 billion of this funding was obligated for awards to states, localities, territories and tribal organizations, but funding was also obligated and expended by HHS agencies for testing-related activities, such as procurement of testing supplies and funding for testing for the uninsured. [137]

For certain funds appropriated specifically to be made available to states, localities, and territories for testing and related purposes, HHS awarded funding through the CDC’s longstanding Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC) Cooperative Agreement. The ELC program is intended to enhance the capacity of state public health departments to cohesively and comprehensively address infectious disease needs. [138] According to CDC guidance, allowable costs for COVID-19 testing funding through the ELC program include personnel, laboratory equipment and necessary maintenance contracts, collection supplies, courier service contracts, and hardware and software necessary for robust implementation of electronic laboratory and surveillance data, among others. As a condition of funding, ELC recipients were required, within 30 or 60 days of receiving an award, to submit a work plan and budget describing proposed activities. [139]

In addition to the testing-specific funds distributed through the ELC, jurisdictions received other funding to support response activities. For example, the CARES Act appropriated $150 billion to the Coronavirus Relief Fund (CRF) for payments to states, localities, territories, and tribal organizations for necessary expenses incurred due to the COVID-19 public health emergency. Jurisdictions could use these funds to further support testing. In addition, the American Rescue Plan of 2021, enacted on March 11, 2021 appropriated $47.8 billion to HHS to carry out activities to detect, diagnose, trace, and monitor SARS-CoV-2 and COVID-19 infections and mitigate the spread of COVID-19. [140] These activities include implementation of a national testing strategy, manufacturing and procurement of tests, and assistance to state, local, and territorial health departments. The appropriation is available until expended.

Overview of Key Issues

Selected jurisdictions told us that funding for testing was generally sufficient for the short term. Officials from all nine selected jurisdictions told us in January 2021 that they had sufficient funding for testing in the immediate future. Some officials told us this was in part due to the availability of an additional $19.11 billion in ELC funding from the Consolidated Appropriations Act, 2021 enacted in late 2020. These officials told us that federal funding allowed them to meet their immediate testing needs by increasing laboratory capacity and public health infrastructure. For example, these officials said they used ELC funds to support testing through various activities including
  • funding local health departments,
  • contracting with laboratories for testing services,
  • purchasing testing equipment and supplies,
  • purchasing information technology to manage testing data, and
  • hiring additional staff, such as laboratory technicians and case investigators.

HHS reported that $35.5 billion of COVID-19 relief funding had been made available for testing activities by jurisdictions—of which about $30 billion had been obligated through ELC awards—as of February 28, 2021. (See table below.)
Obligations and Expenditures of Federal Funding for Testing-Related COVID-19 Response Activities Provided to States, Localities, and Territories through the Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC) program, as of February 28, 2021

Key activity

Obligations
($ billions)

Expenditures
($ billions)

Percentage of obligated amounts expended, as of February 28, 2021

CARES Act ELC funding (March 27, 2020)

0.6

0.1

16.67

Paycheck Protection Program and Health Care Enhancement Act ELC funding (April 24, 2020)

10.3

1.9

18.45

Consolidated Appropriations Act, 2021 ELC funding (December 27, 2020)

19.1

-

0.00

Total support to state, local, and territorial preparedness through ELC

30.0

2.0

6.67
Source: GAO analysis of information provided by the Department of Health and Human Services. | GAO-21-387

Note: These amounts do not include funds appropriated and obligated for tribal organizations as those funds are not awarded through the ELC program. For example, the Indian Health Service (IHS) will provide $750 million in funds appropriated by the Paycheck Protection Program and Health Care Enhancement Act to IHS, tribal, and urban Indian Health programs to expand testing capacity and testing-related activities. In addition, these laws may have appropriated additional amounts that were available, but not required to be used, for testing-related COVID-19 response activities for states, localities, and territories. This table reflects only those amounts with availability limited to this purpose.

While it appears as though a relatively small percentage (about 7 percent) of the $30 billion in federal testing funding obligated for jurisdictions has been expended, we found this is due, in part, to funding availability time frames. First, much of the $30 billion was awarded relatively recently in January, 2021. Second, officials from six of nine selected jurisdictions, as well as three of four selected state and local public health stakeholder groups we interviewed, told us they or their members prioritized spending federal funds whose availability ended earliest. For example, some of these jurisdiction officials told us they began using ELC funds, which CDC made available until late 2022, to support testing largely after exhausting payments from the Coronavirus Relief Fund, which originally covered costs incurred only through the end of 2020. [141] (See figure below). Additionally, officials told us they have used ELC funds to hire staff and contract with laboratories, and that these jurisdiction-level obligations will be paid out over the full life of the ELC award.

Timeline of Selected Federal Funding Availability to States, Localities, Territories, and Tribal Organizations Used to Support Coronavirus Testing

Note: The CARES Act allows recipients to use CRF funds for eligible costs incurred beginning on March 1, 2020. ELC recipients may have applied awards to costs incurred up to 90 days prior to receiving awards and some reimbursed costs may have predated enactment of applicable appropriations. See 45 C.F.R. § 308(d)(1) (2019).
aELC awards are funds awarded through the Centers for Disease Control and Prevention’s (CDC) Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC) Cooperative Agreement.

More than half of selected jurisdictions told us they had concerns about maintaining testing capacity and preparedness in the longer term. Our prior work on ELC and other HHS programs that provide funding to jurisdictions for preparedness activities has found that funding to jurisdictions had generally decreased over time before the pandemic. [142] Such decreases have limited state and local preparedness capacity—such as being able to maintain preparedness staff—and have increased the importance of supplemental appropriations to respond to infectious disease threats. [143]

While the supplemental funding has helped jurisdictions address needs to respond to the pandemic in the short term, most jurisdictions interviewed for this report had concerns about future testing and related preparedness. Officials from five of nine jurisdictions told us they were concerned about their ability to maintain current testing efforts over the long run. For example:
  • Officials from one jurisdiction told us they did not have a sufficient public health workforce to support widespread virus testing prior to the pandemic. These officials told us they are concerned that without ongoing supplemental federal funds they will be unable to keep the trained epidemic and laboratory workforce they developed using federal funds for Coronavirus response.
  • Officials from another jurisdiction told us its public health funding had declined by almost 50 percent over the last decade. These officials told us that, as a result, their jurisdiction had reduced its epidemiology staff and their office was only able to employ one epidemiologist on a part-time basis prior to the pandemic, leaving the jurisdiction with no capacity to respond to new infectious diseases. While officials said the temporary funding available from the COVID-19 relief laws helped them respond to COVID-19, they added that when the next pandemic occurs, they will face the same challenges building a workforce to support testing if additional funds for public heath are not provided beforehand.

New funding available for testing appropriated by the American Rescue Plan Act of 2021 may help ameliorate concerns about the sufficiency of funding for COVID-19 testing in the longer term. Specifically, $47.8 billion—to remain available until expended—was appropriated to HHS to carry out activities to detect, diagnose, and monitor COVID-19 infections and to mitigate the spread of COVID-19, including through support to states, localities, and territories. [144] While this will likely bolster response efforts for COVID-19 testing, it is too soon to know whether this new funding will meet longer term needs. We will continue to monitor the use of federal funding for testing.

Agency Comments

A copy of this enclosure was sent to the Department of Health and Human Services and the Office of Management and Budget. CDC provided technical comments, which we incorporated as appropriate. The Office of Management and Budget did not provide comments on this enclosure.

Methodology

To conduct this work, we examined federal law and agency guidance related to federal funding for COVID-19 testing. We also obtained HHS data on obligations and expenditures for COVID-19 testing as of February 28, 2021, as well as written responses to questions from relevant agency officials. To assess the reliability of the data reported by HHS, we reviewed HHS documentation, obligation data published by CDC, and information from the federal spending database, USAspending.gov, as well as from HHS’s spending database, taggs.hhs.gov, and we determined that the HHS reported data were sufficiently reliable for the purposes of our reporting objective.

Furthermore, we selected a nongeneralizable sample of nine jurisdictions (eight states and one territory) and interviewed officials from those departments of health to obtain information on their experiences using federal funding for COVID-19 testing. We selected these jurisdictions to achieve variation in geographic region, testing volume, and case counts, among other things. In doing so, we spoke with officials from Arizona, Louisiana, Michigan, Pennsylvania, Puerto Rico, South Dakota, Texas, Vermont, and Washington.

Additionally, we obtained perspectives from a set of four stakeholder groups representing state and local public health officials, including groups that represent over 100,000 state and local public health officials and epidemiologists, as well as other individuals knowledgeable about funding for COVID-19 testing.

Contact information: Mary Denigan-Macauley, (202) 512-7114, deniganmacauleym@gao.gov

Related GAO Products

Infectious Disease Threats: Funding and Performance of Key Preparedness and Capacity-Building Programs. GAO-18-362 . Washington, D.C.: May 24, 2018.

Combating Terrorism: Evaluation of Selected Characteristics in National Strategies Related to Terrorism. GAO-04-408T . Washington, D.C.: February 3, 2004.

Medicaid Enrollment, Spending, and Flexibilities

While waivers and other flexibilities, as well as increased federal Medicaid funding, have helped states respond to the public health emergency, they are not permanent. States will face challenges in resuming normal Medicaid activities, including backlogs for redetermining beneficiary eligibility for Medicaid coverage.

Entity involved: Centers for Medicare & Medicaid Services, within the Department of Health and Human Services

Key Considerations and Future GAO Work

Since the beginning of the public health emergency, states have implemented various flexibilities and put certain eligibility renewals and redeterminations on hold in their Medicaid programs. States have also received additional federal funds to manage the increased number of individuals enrolled in Medicaid. These funds are set to be reduced to pre-public health emergency levels at the end of the quarter in which the public health emergency ends.

While the public health emergency is in effect at least through April 20, 2021, and according to the Acting Secretary of Health and Human Services, it will likely continue at least through the end of 2021, the Centers for Medicare & Medicaid Services (CMS) began issuing guidance and tools to states in December 2020 on resuming normal activities once the public health emergency has ended, including redetermining beneficiaries’ eligibility for Medicaid enrollment. The agency also plans to issue guidance on resuming Medicaid program integrity activities.

Medicaid officials we interviewed from eight selected states expressed concerns about various aspects of resuming operations post-public health emergency. [145] For example, most states expressed concerns about resuming normal activities at the same time additional federal funding is ending. State Medicaid officials’ concerns included resolving eligibility redetermination backlogs and enrolling beneficiaries ineligible for Medicaid coverage into new health insurance coverage. We will continue to monitor CMS guidance and states’ responses to the end of public health emergency going forward.

Background

Medicaid is one of the nation’s largest sources of funding for health care services for low-income and medically needy individuals, covering an estimated 77 million people and spending an estimated $673 billion in total federal and state spending in fiscal year 2020. [146] The federal government matches states’ spending for Medicaid services according to a statutory formula known as the Federal Medical Assistance Percentage (FMAP). [147]

The Families First Coronavirus Response Act (FFCRA) provided a temporary increase in the FMAP for all qualifying states and territories through the end of the quarter in which the public health emergency, including any extensions, ends. [148] To receive the increased FMAP, states and territories were required to meet certain conditions, such as maintaining Medicaid enrollment for certain beneficiaries through the end of the month in which the public health emergency ends. FFCRA also created an option for states to provide Medicaid coverage of COVID-19 diagnostic testing and related services to uninsured individuals. [149]

States and territories administer their Medicaid programs within broad federal rules and according to state plans approved by CMS, the agency within the Department of Health and Human Services which oversees Medicaid at the federal level. In addition to its normal authority to approve state waiver applications, CMS has additional authorities in certain emergency circumstances to waive Medicaid requirements to help ensure the availability of care. The temporary authorities CMS has approved will terminate based on the conclusion of the public health emergency unless the states make certain temporary changes permanent, for example, by submitting a state plan amendment for CMS’s review and approval.

Overview of Key Issues

Medicaid enrollment. In the months since the beginning of the public health emergency, the number of people covered under Medicaid increased, due in part to increased applications for Medicaid coverage and requirements under FFCRA for states to maintain Medicaid enrollment for certain beneficiaries regardless of their eligibility. To receive the temporary increased FMAP, states must provide continuous coverage to Medicaid beneficiaries who were enrolled in Medicaid on or after March 18, 2020, regardless of any changes in circumstances or redeterminations at scheduled renewals that otherwise would result in termination, through the end of the month in which the public health emergency ends, among other requirements. States may terminate coverage for individuals who request a voluntary termination of eligibility, or who are no longer considered to be residents of the state. As shown in the figure below, from February 2020 through August 2020—the last month for which updated data were available at the time of our reporting—Medicaid enrollment increased by 5.6 million, or 9 percent. Preliminary data for September 2020 suggest this trend continued, with almost 780,000 individuals added to the Medicaid rolls over comparable data in August.

Medicaid Enrollment from October 2019 through September 2020, Preliminary and Updated Data

Notes: Enrollment counts presented in this figure generally represent the total unduplicated number of individuals enrolled in comprehensive benefits as of the last day of the reporting period. Some states reported their data differently. States report preliminary data soon after the close of the reporting month; the preliminary enrollment counts generally do not include individuals with retroactive eligibility or individuals whose applications were not fully processed before the end of the month. States report updated data about one month later; these data are considered more complete because they account for individuals in both of these groups.

Medicaid operations. According to CMS, during the public health emergency all states have delayed processing eligibility and enrollment actions. [150] In December 2020, CMS issued guidance to states on resuming normal eligibility and enrollment operations after the end of the public health emergency. These operations include processing applications received during the public health emergency, redetermining Medicaid eligibility and terminating coverage, as appropriate; for example, terminating coverage for beneficiaries who no longer meet eligibility requirements, but remained enrolled during the public health emergency due to FFCRA requirements. As shown in the figure below, CMS expects states to resume timely processing of all eligibility and enrollment actions within 6 months of the end of the public health emergency.

Centers for Medicare & Medicaid Services Guideline for States Resuming Timely Medicaid Eligibility and Enrollment Actions

Medicaid officials we interviewed in selected states said that CMS has taken helpful actions throughout the public health emergency, such as issuing guidance and being responsive to states’ questions, but also expressed concerns about returning to normal operations. For example, officials in all eight states we interviewed reported that they were concerned about resuming timely processing of eligibility and enrollment actions. According to CMS’s December 2020 guidance, CMS expects this to be completed within 6 months of the end of the public health emergency. Officials in one of the states we interviewed noted that it would be challenging to resume normal operations by this date, since the state will need to resolve the backlog of eligibility redeterminations that have developed since the public health emergency began. Officials in one of the states we interviewed expressed concerns about smoothly enrolling beneficiaries who are no longer eligible for Medicaid into other health insurance coverage, and noted that a health insurance exchange open enrollment period during the transition would be helpful.

In January 2021, the Acting Secretary Health and Human Services issued a letter to state governors indicating that the public health emergency will likely continue through the end of 2021, and that the department will provide states with 60 days’ notice prior to ending the public health emergency. Medicaid officials in one of the states we interviewed had said that sufficient notice of the end of the public health emergency was important for a timely return to normal operations.

Medicaid spending. As of February 28, 2021, COVID-19-related federal Medicaid expenditures totaled approximately $33 billion, or 7 percent of total federal spending on Medicaid services for this time period. [151] The majority of the COVID-19-related spending is for the 6.2 percentage point FMAP increase. The temporary FMAP increase will extend through the end of the quarter in which the public health emergency ends. Medicaid officials in seven of the eight selected states said that the increased FMAP was among the most important Medicaid program changes, for example, to increase provider payments and provide services to an increasing number of beneficiaries. Officials in one of the states we interviewed suggested extending the increased FMAP an additional quarter following the end of the public health emergency. These Medicaid officials anticipated the state budget would fall short of Medicaid program needs in the months following the end of the public health emergency.

Our prior work has shown that state budget challenges can persist well beyond the end of a recession. In June 2020, we urged Congress to use GAO’s FMAP formula to determine the timing and increase in FMAP for any future changes to the current or any future economic downturn. The increased FMAP formula targets variable state Medicaid needs and provides assistance that is automatic, timely (both when to begin and to gradually end assistance), and temporary in response to national economic downturns. Improving the responsiveness of federal assistance to states during economic downturns would facilitate state budget planning, provide states with greater fiscal stability, and better align federal assistance with the magnitude of the economic downturn’s effects on individual states. In January 2021, the Medicaid and CHIP Payment and Access Commission approved a recommendation that Congress should adopt a statutory mechanism to amend the Social Security Act to provide an automatic Medicaid countercyclical financing model, using the prototype we developed as a basis.

The remainder of COVID-19-related spending—about $20 million—was reported by 13 of the 19 states and territories approved to cover COVID-19 diagnostic testing and related services for uninsured individuals with a 100 percent federal match. [152]

The table below summarizes federal Medicaid spending related to the 6.2 percentage point FMAP increase, COVID-19 expenditures in Medicaid programs approved to cover testing for uninsured individuals, and total Medicaid spending for services as of February 28, 2021.
Federal Medicaid COVID-19 and Total Expenditures, by State and Territory, as of February 28, 2021

State or territory

COVID-19-related federal Medicaid expenditures from the 6.2-percentage-point-increased FMAP
($ millions)

COVID-19-related federal Medicaid expenditures for uninsured testing
($ millions)

Total federal Medicaid services expenditures
($ millions)

Alabama

378

N/A

4,819

Alaska

65

N/A

1,498

Arizona

629

N/A

12,366

Arkansasa

337

N/A

5,900

California

4,015

19

65,432

Colorado

465

< 1 million

5,970

Connecticutb

297

< 1 million

4,096

Delawareb

120

N/A

1,689

District of Columbia

167

N/A

2,509

Florida

1,667

N/A

17,962

Georgia

692

N/A

8,323

Hawaiia

110

N/A

1,684

Idaho

129

N/A

2,053

Illinoisa

1,226

< 1 million

16,234

Indiana

744

N/A

11,276

Iowa

283

< 1 million

3,988

Kansas

242

N/A

2,552

Kentuckya

520

N/A

10,203

Louisiana

565

< 1 million

10,055

Maine

178

< 1 million

2,342

Maryland

566

N/A

7,854

Massachusetts

985

N/A

11,266

Michigan

937

N/A

14,543

Minnesotab

692

< 1 million

7,092

Mississippi

351

N/A

4,728

Missouri

663

N/A

8,017

Montana

67

0

1,612

Nebraska

144

N/A

1,495

Nevada

173

0

3,200

New Hampshire

109

< 1 million

1,411

New Jersey

804

N/A

10,725

New Mexico

278

< 1 million

5,453

New Yorkb

3,634

N/A

46,602

North Carolina

904

< 1 million

11,001

North Dakota

62

N/A

836

Ohiob

1,283

N/A

19,333

Oklahoma

308

N/A

3,745

Oregon

460

N/A

8,263

Pennsylvania

1,788

N/A

21,875

Rhode Island

132

N/A

1,809

South Carolina

416

< 1 million

5,142

South Dakota

54

N/A

639

Tennessee

681

N/A

7,741

Texas

2,607

N/A

29,114

Utah

153

< 1 million

2,530

Vermont

87

N/A

1,069

Virginiac

473

N/A

6,676

Washingtonb

541

N/A

9,598

West Virginia

201

0

3,486

Wisconsin

600

N/A

6,413

Wyominga

35

N/A

365

States total d

33,018

20

454,585

American Samoa

3

N/A

40

Guam

4

N/A

105

Northern Mariana Islands

3

0

42

Puerto Rico

100

0

2,456

Virgin Islands

3

0

73

Territories total d

113

0

2,715
Legend:
FMAP = federal medical assistance percentage
N/A = Not applicable. States that are not approved to provide COVID-19 testing for uninsured individuals as of February 28, 2021.
Source: GAO analysis of Centers for Medicare & Medicaid Services’ data accessed on March 1, 2021. | GAO-21-387

Note: COVID-19 related and total federal Medicaid expenditure data were available for the second, third, and fourth quarters of fiscal year 2020 (January 1, 2020, through September 30, 2020), and for the first quarter of fiscal year 2021 (October 1, 2020, through December 31, 2020). Some preliminary expenditure data were also available for the first two months of the second quarter of fiscal year 2021 (January 1, 2021, through February 28, 2021). States are not required to report expenditures for the second quarter of fiscal year 2021 until April 30, 2021, 30 days after the end of the quarter. Expenditures do not include expenses for program administration. State expenditures are reviewed by states and certified as being Medicaid allowable expenditures. Both certified and uncertified state expenditures are preliminary, as they are subject to further review and are likely to be updated as states continue to report their expenditures and receive federal matching funds. States can report payments and adjustments to payments up to 2 years after a quarter ends. Expenditure data are certified unless otherwise noted.
aFive states reported preliminary expenditures for the first two months of the second quarter of fiscal year 2021 (January 1, 2021, through February 28, 2021), with only Hawaii having certified its expenditures thus far.
bSix states reported uncertified expenditures for the first quarter of fiscal year 2021 (October 1, 2020, through December 31, 2020).
cOne state reported uncertified expenditures for the fourth quarter of fiscal year 2020.
dTotals may not sum exactly due to rounding.

State waivers and flexibilities. As of December 17, 2020, CMS reported that the agency had approved more than 600 different waivers, state plan amendments, and other flexibilities to provide states with flexibility to respond to the public health emergency. Common types of flexibilities that states sought and CMS approved are shown in the table below.
Common Types of State Flexibilities Approved by Centers for Medicare & Medicaid Services since March 16, 2020

Purpose of flexibility

Specific state flexibilities approved

Maintain beneficiary eligibility for services
  • Suspended fee-for-service prior authorizations, which are used to demonstrate compliance with coverage and payment rules before beneficiaries can obtain certain services, rather than after the services have been provided.a
  • Extended the dates for reassessing and reevaluating beneficiaries’ needs, which are normally required for beneficiaries to retain eligibility for some home- and community-based services.b

Expand beneficiary eligibility
  • Permitted virtual evaluations, assessments, and person-centered planning normally conducted in person.b
  • Expanded coverage to uninsured individuals for COVID-19 testing.c

Remove obstacles to beneficiary access to care
  • Allowed telehealth to continue to provide some services that were previously provided in person.c
  • Allowed early refills of certain medications to avoid interruption in care.c

Increase the availability of providers
  • Waived some requirements to allow licensed out-of-state providers to enroll in their programs to maintain provider capacity.a,d
  • Authorized payments changed or added for telehealth services.c
Source: GAO analysis of Centers for Medicare & Medicaid Services approval documentation for states and District of Columbia. | GAO-21-387

aStates received approval under section 1135 of the Social Security Act, which authorizes the Secretary of Health and Human Services to temporarily waive or modify certain federal health care program requirements, including Medicaid requirements, to ensure that sufficient health care items and services are available to meet the needs of enrollees during an emergency.
bStates received approval to make changes to their section 1915(c) home- and community-based services waivers under an Appendix K amendment in order to respond to the emergency.
cStates received approval to revise policies in their Medicaid state plan related to eligibility, enrollment, benefits, premiums and cost sharing, and payments. To make these changes, states must submit a State Plan Amendment to the Centers for Medicare & Medicaid Services for approval.
dStates approved to temporarily enroll licensed out-of-state providers must follow certain requirements, which include screening providers to ensure they are enrolled in the Medicaid program and licensed in the state relating to their Medicaid enrollment. Waiver of these federal requirements does not affect state or local licensure requirements.

Medicaid officials from the selected states we interviewed reported that these flexibilities were important for fulfilling their states’ Medicaid program mission. For example, Medicaid officials from all eight states noted that flexibilities to remove obstacles to beneficiary access to care, such as the use of telehealth, have been among the most important during the public health emergency. A Medicaid official in one of the states we interviewed said flexibilities permitting virtual evaluations, for example, provided Medicaid beneficiaries with an added sense of security and safety, while providing needed care.

Officials from all eight states we interviewed reported considering making certain flexibilities approved during the public health emergency permanent after the public health emergency has ended, in particular regarding telehealth. We will continue to monitor the use of services through telehealth, given the oversight challenges presented by the size, growth, and diversity of the Medicaid program.

Oversight of state Medicaid waivers and flexibilities. In our June 2020 report, we raised concerns about the potential effects of state flexibilities, including improper Medicaid payments. In December 2020, CMS reported that the agency plans to release guidance specific to COVID-19 program integrity issues, including beneficiary eligibility. According to CMS, the guidance will outline expectations for states to establish regular Medicaid program integrity operations both during and after the public health emergency, taking into account new changes to state programs as a result of implementing COVID-19 flexibilities. CMS officials have also reported that the agency is conducting and updating risk assessments for all Medicaid waivers and flexibilities issued as a result of the public health emergency. As of January 2021, CMS still plans to release the aforementioned guidance, which will include a discussion of CMS’ Medicaid risk assessment, so that states appropriately account for the risks and vulnerabilities associated with the Medicaid waivers and flexibilities. CMS has not specified when program integrity guidance will be released. We will continue to monitor CMS’s guidance and state efforts and report on our findings going forward.

Single audit requirements. The Single Audit Act establishes a requirement for federal award recipients (e.g., states, the District of Columbia, local governments, U.S. territories, Indian tribes, and nonprofit organizations) to undergo a single audit when federal award expenditures meet a certain dollar threshold in a fiscal year. The Office of Management and Budget (OMB) issued new guidance as to the applicability of the single audit to COVID-19 relief funding, including how to conduct such audits. Likewise, many federal awarding agencies issued new guidance to award recipients on how those funds should be reported and spent. CMS released several Frequently Asked Questions (FAQs) to provide guidance to state Medicaid agencies in their response to COVID-19 and implementation of the FFCRA and the CARES Act.

Single audits are essential in identifying deficiencies in the award recipient’s compliance with applicable provisions of laws, regulations, contracts, or grant agreements and in its financial management and internal control systems. Correcting such deficiencies can help ensure the appropriate use of federal funds and reduce the likelihood of federal improper payments. Medicaid is on GAO’s 2019 High-Risk list and has the largest reported amount of estimated improper payments out of all federal government programs determined to be susceptible to significant improper payment. For fiscal year 2020, HHS reported that Medicaid’s total estimated improper payments was about $86.5 billion, representing about 42 percent of the total $206.4 billion government-wide estimated improper payments reported for that fiscal year. Auditors who conduct single audits follow guidance in the Single Audit Act’s Compliance Supplement, which OMB updates and issues annually in coordination with federal agencies. Refer to the Single Audits enclosure for more information on single audits.

Agency Comments

We provided a draft of this enclosure to HHS and the Office of Management and Budget for review and comment. HHS provided technical comments, which we incorporated as appropriate. The Office of Management and Budget did not provide comments on this enclosure.

Methodology

To conduct this work, we reviewed federal laws and CMS data from both its Medicaid expenditure reporting system and Medicaid and CHIP performance indicators project. We also reviewed CMS Medicaid guidance, including requirements for administering the optional COVID-19 testing for the uninsured and resuming normal state eligibility and enrollment operations after the end of the public health emergency; and our prior work related to Medicaid. We also reviewed CMS guidance to states on reporting COVID-19 expenditures through the Medicaid expenditure reporting system and conducted data reliability checks on both the state reported-expenditure data and performance indicators. We determined that the CMS data were sufficiently reliable for the purpose of this enclosure.

We also interviewed Medicaid officials from eight selected states regarding flexibilities they requested during the public health emergency, CMS assistance in obtaining and implementing these flexibilities, and plans for resuming normal operations after the public health emergency has ended. We selected states based on geographic diversity, size of the state Medicaid program, and approved Medicaid flexibilities.

Contact information: Carolyn L. Yocom, (202) 512-7114, yocomc@gao.gov

Veterans Health Care

The Veterans Health Administration, within the Department of Veterans Affairs, began executing its COVID-19 vaccination plan following the Food and Drug Administration’s emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine in December 2020. Its vaccination effort could benefit from performance targets and improved metrics for vaccine administration.

Entities involved: Veterans Health Administration, within the Department of Veterans Affairs

Recommendations for Executive Action

The Department of Veterans Affairs Under Secretary for Health should develop metrics to assess the number of vaccines administered by vaccine rollout phase to better assess progress and make any necessary adjustments as needed. VA agreed with our recommendation.

The Department of Veterans Affairs Under Secretary for Health should develop preliminary vaccination targets for when it will move from one vaccination phase to another; or within one phase, from one group of veterans to another. VA agreed in principle with our recommendation.

The Department of Veterans Affairs Under Secretary for Health should collect data on the number of staff and veterans who do not show up for a vaccination appointment to better monitor for completion of the second dose of the vaccine. VA agreed with our recommendation.

Key Considerations and Future GAO Work

The Department of Veterans Affairs (VA) has used COVID-19 relief funds to vaccinate veterans and Veterans Health Administration (VHA) staff. As of March 10, 2021, about 908,000 veterans and 243,000 staff have been fully vaccinated (i.e. received required two doses of the Moderna or Pfizer vaccines, or one dose of the Janssen (Johnson & Johnson) vaccine) by VHA.

We will continue to examine VA’s vaccination efforts, including ongoing work, reviewing how the department used COVID-19 relief funds to distribute and administer vaccines. In addition, we have ongoing work focusing on the vaccination of veterans and staff at VA community living centers.

Background

VA, through VHA, provides health care services to approximately 10 million enrolled veterans. Veterans can access services at one of VHA’s 1,294 sites of care, which includes 170 VA medical centers and about 1,000 outpatient sites. VHA is leading VA’s efforts for the distribution of COVID-19 vaccines.

In September 2020, VHA began planning for the availability of a COVID-19 vaccine, and developed the COVID-19 Vaccination Plan for the Veterans Health Administration, which was most recently updated on December 14, 2020. [153] The document describes several aspects of VHA’s vaccination plan, which include
  • the guiding principles and priorities of VHA’s vaccination effort, such as the safety of veterans and staff;
  • how VHA will operationalize these principles, for example by developing and implementing a plan to distribute the vaccines to facilities, and for administering vaccinations to veterans and staff;
  • roles and responsibilities of national leadership, Veterans Integrated Service Network leadership, and VA medical center leadership; [154]
  • development of an integrated project team to review feedback from VHA staff and recommend revisions to plans and products about the COVID-19 vaccines; [155] and
  • the creation of workgroups to develop vaccine communication, vaccine distribution plans, and vaccination metrics among other things.

Starting in December 2020, the Food and Drug Administration (FDA) took several steps to pave the way for vaccine distribution and administration nationally. Specifically, on December 11, 2020, FDA issued an emergency use authorization (EUA) for the Pfizer-BioNTech (Pfizer) COVID-19 vaccine. [156] A week later, on December 18, 2020, FDA issued an EUA for the Moderna vaccine. More recently on February 27, 2021, FDA issued an EUA for the Janssen vaccine. [157]

After the first EUA was in place, on December 16, 2020, VA released guidance through a memo to Veterans Integrated Service Network and VA medical center leadership detailing how vaccines would be distributed to sites, how to schedule vaccination appointments, how to document administering the vaccine, and information on training and data reporting requirements. [158] VA updated this guidance on December 23, 2020. [159] In addition, beginning on December 29, 2020, VA published vaccine information in Spanish and on January 26, 2021 began publishing the information in Tagalog.

VHA received approximately $17.2 billion in supplemental appropriations from the CARES Act to assist its response to COVID-19. According to VHA officials, they expect staffing to be the primary cost associated with vaccine distribution. [160] As part of the American Rescue Plan Act of 2021, VA will receive an additional $14.482 billion of funding for COVID-19 related health care. [161]

Overview of Key Issues

As of March 11, 2021, VA has recorded 236,176 COVID cases, including about 4,600 active cases among veterans and 130 active cases among staff. In addition, VA has recorded more than 10,000 known COVID-19 deaths among its patient population and 134 COVID-19 deaths among its staff.

The primary goal of VA’s vaccination effort is to lower the COVID-19 risk of infection and severe disease. To achieve this goal, VA plans to offer vaccines to the roughly 10 million eligible veterans currently enrolled in VHA’s health care system and its approximately 419,000 staff. According to VHA, many enrolled veterans are at a higher risk of infection or severe disease from COVID-19. For example, more than half of the veteran population enrolled in VHA services are over the age of 65 and a large proportion have at least one high-risk medical condition, such as cardiovascular disease. VHA also acknowledges that many staff are at risk for COVID-19, and can potentially transmit the virus to high-risk veterans. According to VHA, its staff are not required to receive the vaccine. However, VHA has provided education to its staff on vaccine safety and education and they are encouraged to become vaccinated.

VHA’s vaccination approach. VHA has a phased approach for its vaccination effort. Veterans and staff are prioritized based on their risk for either COVID-19 transmission, morbidity, or mortality, with higher risk individuals included in earlier phases. According to VHA, a risk-based phased approach is necessary as demand for the vaccine continues to outpace supply. VHA’s approach follows a risk stratification framework based on the Centers for Disease Control and Prevention (CDC) guidance, and VHA’s previous vaccination efforts. [162] See table below for details on VHA’s vaccination prioritization and phases.

Veterans Health Administration (VHA) COVID-19 Vaccination Phases and Prioritization, December 14, 2020

Phase a

Types of VHA staff who will receive vaccines

Groups of veterans who will receive vaccine

1a

All health care personnel

Veterans in VHA long term care facilities and inpatients at VHA Spinal Cord Injuries and Disorders Centers

1b

Veterans 75 and older receiving VHA care

Veterans under the age of 75 who are in high risk groups, such as veterans experiencing homelessnessb

Veterans who are frontline essential workers as defined by CDCc

1c

Other VHA personnel, non-health care staff

Veterans 65-74 years of age receiving VHA care

Veterans with a high-risk condition, such as cancer or obesity

Other essential workers as defined by CDC
Source: Department of Veterans Affairs, COVID-19 Vaccination Plan for the Veterans Health Administration. | GAO-21-387

Notes: VHA’s vaccination prioritization is for eligible veterans enrolled in its health care system.
aVHA’s risk stratification is based on Centers for Disease Control and Prevention (CDC) guidance and VHA’s previous vaccination efforts. CDC’s guidance includes recommendations for prioritizing high-risk groups, such as health care personnel and long-term care residents, to receive vaccine doses first. CDC’s guidance allows for flexibility. For example, agencies can decide to further prioritize within a particular group.
bVHA considers veterans in these groups high risk because they have either an increased risk of COVID-19 transmission and mortality.
cCDC defines essential workers as those individuals who conduct a range of operations and services in industries that are essential to ensure the continuity of critical functions in the United States. Examples of Phase 1b essential workers include grocery store workers, postal workers, and public transit workers.

In addition, VHA developed a tool for facilities to help identify high-risk veterans. The tool identifies veterans by conditions such as age and comorbidities, which are known to elevate risk associated with COVID-19. According to officials from several VA medical centers in our review, the tool has been helpful in determining which staff and veterans to vaccinate first.

VHA’s top priorities are staff and veterans who are most at risk of contracting COVID-19 and of having the most severe symptoms. In particular, VA has prioritized:

Community living centers. According to CDC data, 21 percent of COVID-19 deaths have occurred in nursing home facilities, including community living centers (CLC)—which are owned and operated by VHA. [163] According to VHA’s risk stratification framework, staff working in CLCs were the first group of staff to be vaccinated because they interact with a greater number of residents and can more easily spread the virus. Veterans residing in CLCs were the first veterans to be vaccinated. According to VHA data we reviewed, 95 percent of CLC residents have received at least one dose of vaccine, and 86 percent have been fully vaccinated as of March 14, 2021.

Homeless veterans. Homeless veterans are also among the first groups of veterans eligible to receive a vaccine in VHA’s stratification framework. According to VHA, homeless veterans are a priority because they are at an increased risk of needing to be in congregate living settings where there is increased risk of infection, particularly during the winter months. Further, according to VHA, homeless veterans are more likely to have high-risk health conditions and be older, elevating the risk of morbidity and mortality from COVID-19. According to VHA officials, outreach efforts include bringing vaccine to homeless veterans in VA-funded congregate living environments, and a laminated pocket card with information about COVID-19 vaccination at VHA.

VHA estimates that as of December 14, 2020, there were about 242,000 homeless veterans. As of March 14, 2021, VHA data show that 41,253 homeless veterans have received at least one dose of vaccine, and 21,574 have been fully vaccinated.

VHA’s progress in distributing and administering vaccines. On December 14, 2020, VHA began distributing the initial doses of the Pfizer vaccine to 37 facilities. VHA reported that these facilities were selected because they had the ultra-cold storage capacity necessary for storage of the vaccine. [164] On December 21, 2020, VHA began distributing initial doses of the Moderna vaccines to 113 facilities that were identified based on factors such as their ability to appropriately store the vaccine. According to VHA, the Moderna vaccine is more suitable for smaller facilities due to less stringent cold storage requirements and smaller minimum order size, and it plans to focus distribution of those vaccines to rural and remote areas. [165] On March 3, 2021, VA received its first doses of the Janssen (Johnson & Johnson) vaccine. According to VA, the Janssen vaccine will help VA more effectively reach rural veterans as it only requires one dose. As of March 18, 2021, 868 of VHA’s 1,294 sites of care had received vaccine doses. VHA reported that it will distribute vaccines to additional facilities as vaccination supply increases.

As of March 10, 2021, VHA facilities had administered about 2.5 million vaccine doses to veterans and about 518,000 vaccine doses to staff. See figure below for details on the number of doses VHA has received, and administered.

Department of Veterans Affairs COVID-19 Vaccine Administration, as of March 10, 2021

Note: Both the Pfizer and Moderna vaccines require two doses separated by 3 weeks and 1 month, respectively. The Janssen vaccine requires one dose. Fully vaccinated individuals have either had two doses of the Pfizer or Moderna vaccines, or one dose of the Janssen vaccine.

VHA facilities noted challenges in planning due to vaccine allocation changes and uncertainty. Staff at VHA facilities in our review—12 facilities that received the Pfizer vaccine and 12 facilities that received the Moderna vaccine—told us that predictable vaccine allocation, or specified doses of vaccines to be made available, would improve their ability to plan for administration of the vaccine.
  • Facilities plan based on their assigned allocations of vaccines, which are based on the number of staff and veterans receiving care at a facility who are in specific risk categories (see above table showing COVID-19 vaccination phases and prioritization for details).
  • Staff from 18 of the 24 facilities in our review told us the vaccine supply chain was a challenge for several reasons, including the timeline for vaccine delivery changing and not receiving the quantity of vaccine they ordered. For example, staff at one facility reported to us receiving three times the amount of vaccine they initially planned for and noted that the facility had to make last-minute staffing changes to accommodate the increase. Further, staff from several of these 18 facilities told us that the uncertainties created challenges in scheduling appointments, staffing clinics, and accurately communicating with veterans and staff about what to expect.
  • Staff from some facilities in our review told us that uncertainty is challenging to manage because vaccination efforts are labor intensive to plan for and coordinate with staff. For example, vaccination clinics require coordination across a multidisciplinary team, such as staff from pharmacy, public affairs, scheduling, and information technology (IT) management. In addition, staff from some facilities told us the high volume of veterans to call and schedule for vaccination appointments, and the number of staff necessary to operate vaccination clinics is challenging.

Although VHA has received most of the vaccine doses it has ordered, VHA officials said planning at the facility level is challenging because VA learns its allocation of vaccine approximately one week in advance. Specifically, VA learns its weekly allocation of vaccine each Tuesday—it then uses its risk stratification framework to determine how these vaccines will be distributed across the country—and doses arrive on site between Monday and Thursday the following week.

VHA may face difficulties in assessing vaccination progress. Although VHA has outlined a phased vaccination approach, it has not developed metrics for tracking vaccines by phase, has not created vaccination targets for each phase, and does not track no-show appointments.

Phase-specific data. VHA is utilizing a phased vaccine rollout; however, VHA’s current metrics do not capture vaccine data by phases. VHA’s vaccination phases may include veterans based on a combination of factors. For example, Phase 1c includes veterans who are 65 and older and veterans under the age of 65 who have high-risk conditions or are essential workers. [166] According to VHA officials, VHA does not have data on all factors that define a particular phase, such as employment data to identify essential workers. However, VHA officials stated they are able to track age and health condition data, which includes the majority of some phases, such as 1b. Using data VHA currently has access to, VHA may be able to create metrics for some vaccination phases. VHA’s lack of data by vaccination phase is inconsistent with our Standards for Internal Control in the Federal Government, which states that management should use quality information to achieve objectives. Without the ability to review vaccination data by phase, VHA is not able to determine which facilities may be at an earlier phase than others and direct resources or assistance to those facilities.

Vaccination targets. VHA does not have targets as to when it will move from one vaccination phase to another; or within one phase, from one group of veterans to another. This lack of vaccination targets is inconsistent with effective management practices. We have previously reported that developing measurable targets is an effective practice to assess progress in meeting program goals.

VHA stated that creating vaccination targets is currently challenging given that vaccine supply currently lags demand that and the amount of vaccine available to VHA is unpredictable and fluctuates from week to week. Although the unpredictable supply of vaccine doses may prevent VHA from developing absolute targets, our previous work has shown that setting preliminary targets is an effective strategy when an agency cannot develop absolute targets. Without preliminary vaccination targets, VHA may not be able to determine its progress in vaccinating staff and veterans who have the highest risk, and signal to those lower risk groups when they might anticipate being vaccinated.

Appointment no-show data. VHA does not have metrics related to staff and veterans who do not show (no-shows) for their vaccination appointments, which is inconsistent with its own vaccination goal to track vaccine administration and completion of both doses of vaccine. [167] In addition, Standards for Internal Control in the Federal Government state that management should use quality information to achieve objectives. Without data on no-shows, VHA may be at an increased risk for not being able to determine the extent to which staff and veterans are not showing for appointments for their second vaccinations, and may miss opportunities to better target outreach to individuals not showing up for appointments. Officials told us that VHA is collecting data required by the CDC, which does not include no-show appointments. [168]

VHA’s outreach to minority and rural veterans. We have previously reported—including in our December 2019 report on opportunities for VA to address racial and ethnic disparities—that racial and ethnic minority veterans have had worse health outcomes for some diseases. Further, members of specific racial and ethnic minority populations, including Black, Hispanic, American Indian, or Alaska Native, have borne a disproportionate share of COVID illness and death in the United States, according to CDC data. (See our related Health Disparities enclosure for more information. VHA’s vaccination plan acknowledges the importance of equitably administering the vaccine, and describes steps taken by the agency to develop communication products targeted at minority and rural veterans. (See tables below for information on vaccines delivered to certain veteran groups, by race and ethnicity, as of March 11, 2021.)

Since beginning vaccinations in mid-December 2020, VHA reported that its COVID-19 Communications Team meets regularly with a variety of stakeholders, including veterans groups representing different racial and ethnic populations and minority outreach coordinators. [169] These efforts led VHA to take several actions, including developing videos to address vaccine hesitancy. For example, according to VHA officials, one video features clinicians discussing vaccine hesitancy and why they chose to be vaccinated. According to VHA officials, these videos are played at VHA facilities, and shared on multiple platforms, including VA’s social media platforms.
Administration of vaccine to veterans aged 65 and older by race as of March 11, 2021

Race

Number of veterans that are fully vaccinated

White

634,240

Black or African American

111,901

Multiple

4,830

Asian

6,225

American Indian or Alaskan Native

3,961

Native Hawaiian or Other Pacific Island

5,584

Unknown

37,541

Declined to answer

21,418

Total

825,701
Source: GAO analysis of Department of Veterans Affairs data. | GAO-21-387
Administration of vaccine to veterans aged 65 and older by ethnicity as of March 11, 2021

Ethnicity

Number of veterans that are fully vaccinated

Non-Hispanic or Latino

739,233

Hispanic or Latino

41,230

Unknown

32,292

Declined to answer

12,946

Total

825,701
Source: GAO analysis of Department of Veterans Affairs data. | GAO-21-387

VHA officials told us that they anticipated it would be a challenge to deliver vaccine doses to rural areas because of constraints around storage and handling of the vaccine. Staff from several facilities in our review said it was challenging to distribute doses of vaccine from VA medical centers to community-based outpatient clinics due to storage and handling requirements. Specifically, VHA officials said both the Pfizer and Moderna vaccines—which must be stored -70 and -20 degrees, respectively—require 24/7 temperature monitoring and staff availability to address any temperature deviations. According to VHA, smaller facilities may not have staff available 24/7 to address potential deviations. Further, according to VHA officials, the requirements for transporting vaccine make doing so challenging.

Since beginning vaccinations, VHA has made adjustments to address these challenges and get more vaccine into rural communities. For example, VHA initially required facilities to have backup power in place to ensure continuous maintenance and monitoring of vaccine temperature. According to VHA officials, this requirement was waived to increase the number of locations eligible to receive vaccine because backup power was not available at smaller community-based outpatient clinics.

Agency Comments

We provided a draft of this enclosure to VA for review and comment. VA provided technical and general comments on this enclosure, which we incorporated as appropriate. VA’s general comments are reproduced in appendix XII .

VA agreed with our recommendation to develop metrics to assess the number of vaccines administered by vaccine rollout phase in order to better assess progress, and provided a target completion date of October 2021. VA is using a phased approach to provide vaccines because vaccine demand currently outpaces supply. Without data by phase, VA is not able to determine which facilities are at an earlier phase and may require additional resources or assistance to vaccinate veterans and staff who are at the highest risk.

VA agreed in principle with our recommendation to develop vaccination targets for when it will move from one vaccination phase to another; or within one phase, from one group of veterans to another. Although VA acknowledged there are many factors to consider when moving from one phase to another, and the importance of flexibility for local conditions, VA did not provide dates for when it would develop targets. We reiterate the importance of developing preliminary targets to determine vaccination progress and signal to veterans and employees when they may expect to be vaccinated.

VA agreed with our recommendation to collect data on the number of staff and veterans who do not show up for a vaccination appointment to better monitor for completion of second dose of the vaccine. VA indicated that it is collecting data that can track the completion of first and second doses; however, these data do not indicate if staff or veterans missed their second dose because they did not show for their appointment. A missed second dose, for example, could be due to delays in shipment or other supply issues. Without no-show data, VA may miss opportunities to better target outreach to individuals not showing up for appointments.

Methodology

To conduct this work, we reviewed VHA’s vaccination plan and related guidance for facilities administering the vaccines. In addition, we analyzed VHA data on the number of COVID-19 vaccines VHA facilities administered from mid-December through March 18, 2021. We assessed the reliability of the data used in our analyses by conducting manual checks and obtaining written responses from agency officials about the data. We determined the data were sufficiently reliable for the purpose of this enclosure. We also collected information from 24 VHA facilities—12 facilities that received the Pfizer vaccine and 12 facilities that received the Moderna vaccine—to understand their vaccination experiences. We selected these facilities to reflect a range of geography and complexity level. [170] Information from these facilities is not generalizable across all VHA facilities. We also spoke to representatives from two veteran service organizations, the American Legion and Paralyzed Veterans of America, to gain additional context.

Contact information: Debra A. Draper, (202) 512-7114, draperd@gao.gov ; Sharon Silas, (202) 512-7114, silass@gao.gov

Related GAO Products

COVID-19: Federal Efforts Accelerate Vaccine and Therapeutic Development, but More Transparency Needed on Emergency Use Authorizations. GAO-21-207 . Washington, D.C: November 17, 2020.

VA Health Care: Opportunities Exist for VA to Better Identify and Address Racial and Ethnic Disparities. GAO-20-83 . Washington, D.C.: December 11, 2019.

Managing for Results: Strengthening Regulatory Agencies’ Performance Management Practices. GAO/GGD-00-10 . Washington, D.C.: October 28, 1999.

Military Personnel Vaccinations

The Department of Defense reported 255,716 cumulative, confirmed cases of COVID-19 as of March 10, 2021; has a phased approach for vaccinating 11.3 million DOD personnel and other eligible beneficiaries; and began administering vaccines in December 2020.

Entities involved: Department of Defense, including the Defense Health Agency, Defense Logistics Agency, geographic combatant commands, and military departments.

Key Considerations and Future GAO Work

We have ongoing work examining the Department of Defense’s (DOD) vaccination efforts and broader efforts to protect personnel against COVID-19. We plan to report the results of this work in spring 2021. We will also continue to monitor DOD’s vaccination progress.

Background

DOD, through its Defense Health Program, provides worldwide medical services to military personnel and other eligible beneficiaries (approximately 9.6 million individuals total) through 475 military medical treatment facilities and the delivery of TRICARE benefits. [171] The Defense Health Agency (DHA) manages and oversees DOD’s immunization programs and leads efforts to plan for the distribution of COVID-19 vaccines.

Geographic combatant commands, the three military departments, other DOD components, and the U.S. Coast Guard are responsible for planning distribution of COVID-19 vaccines within their specific areas of responsibility. Logistics personnel consolidate requests from medical treatment facilities or other vaccination sites and send them to the U.S. Army Medical Materiel Agency Distribution Operations Center, which enters the orders into the Department of Health and Human Services’ vaccine ordering system.

Overview of Key Issues

Prevalence of COVID-19 among DOD personnel and dependents. As of March 10, 2021, DOD reported 255,716 cumulative, confirmed cases of COVID-19 among its workforce personnel and dependents of military servicemembers. See the table below for more detailed information by personnel category, including for dependents of military servicemembers.
Number of Cumulative, Confirmed Cases of COVID-19, Hospitalizations, and Deaths Reported by the Department of Defense (DOD), as of March 10, 2021

Cumulative cases

Hospitalizations

Deaths

Military servicemembers (active and reserve components)

166,357

1,424

24

Dependents

25,272

364

10

Civilians

47,070

1,349

202

Contractors

17,017

491

69

Total

255,716

3,628

305
Source: DOD data from defense.gov/explore/spotlight/coronavirus/, accessed March 10, 2021. I GAO-21-387

Note: DOD defines a “COVID-19 case” as one confirmed by a positive molecular laboratory test and “dependents” as family members (according to specified criteria) of military servicemembers.

DOD vaccination approach. In light of the limited supply of COVID-19 vaccines, DOD has planned and implemented a phased approach to vaccinating up to approximately 11.3 million eligible personnel, including military servicemembers and their dependents, other beneficiaries (e.g., retired military servicemembers and their dependents), civilian employees, and selected contractor personnel. [172] DOD established a priority framework for determining which groups of eligible personnel should be vaccinated based on guidance from the Centers for Disease Control and Prevention (table).
Department of Defense (DOD) COVID-19 Vaccine Prioritization for Military Servicemembers, Other Beneficiaries, Civilian Employees, and Contractors

Vaccination phase

Population group

1a

All health care providers, health care support, and emergency services and public safety personnel

1b

Personnel providing critical national capabilities, personnel forward deployed to austere environments and those preparing to deploy to locations outside the U.S., DOD beneficiaries ages 75 years and older, and frontline essential workers

1c

DOD beneficiaries ages 65–74 and those ages 16–64 with increased risk for severe illness as defined by the Centers for Disease Control and Prevention, personnel deployed or serving temporary duty for more than 30 days outside the U.S., and essential workers not previously included in phases 1a or 1b

2

Remaining population ages 16 years and oldera
Source: Defense Health Agency. I GAO-21-387

aAs of February 24, 2021, only the Pfizer-BioNTech COVID-19 vaccine is authorized for individuals ages 16 and 17 years.

DHA’s immunization plan includes distributing the first available vaccines developed and authorized through the federal response effort. DOD distributed the first two vaccines authorized for emergency use within days after each authorization was made. Specifically:
  • On December 11, 2020, the Food and Drug Administration (FDA) issued an emergency use authorization for the Pfizer-BioNTech vaccine. [173] The same day, the U.S. Army Medical Materiel Agency Distribution Operations Center—responsible for managing vaccine shipments, to include tracking them through their delivery to states and territories—initiated shipments to the first of 14 initial vaccination sites within the U.S., selected because of their cold storage capabilities, proximity to substantial numbers of high-priority personnel, and access to sufficient medical personnel to administer the vaccines and monitor recipients after vaccination.
  • On December 18, 2020, the FDA issued an emergency use authorization for the Moderna vaccine and, within 2 days, the Army Medical Materiel Agency Distribution Operations Center initiated vaccine shipments to the first of 61 vaccination sites in the U.S. for that week. Within 4 days, the Defense Logistics Agency—responsible for shipments to foreign countries, deployed locations, and ships—began shipping Moderna doses to locations outside the U.S.

On February 27, 2021, the FDA issued an emergency use authorization for the Janssen (Johnson & Johnson) single-dose vaccine. DOD began administering the Janssen vaccine on March 2, 2021. DHA officials stated that the immunization plan may incorporate other new vaccines as they are authorized for emergency use by the FDA, including vaccines that DOD is developing.

Vaccination progress. From December 2020 through February 2021, DOD expanded its number of vaccination sites in the U.S. and overseas to more than 500 locations, according to briefing reports to the DHA Director. The percentage of vaccines DOD has administered at these sites relative to its on-hand supply has increased almost every week since vaccinations began in December 2020. As shown in the figure below, as of March 10, 2021, DOD had administered 1,412,016 vaccine doses, or about 87 percent of the doses delivered to its vaccination sites. A total of 875,707 individuals, or about 13 percent of DOD’s target population of 6.9 million in all vaccination phases, had received at least one dose, and 536,309 of these individuals had been fully vaccinated.

Vaccine Doses Received by Department of Defense Vaccination Sites and Administered to Individuals as of March 10, 2021

Notes: The 6.9 million eligible individuals targeted include those in all phases of DOD’s vaccination plan as of February 2021––phases 1a, 1b, 1c, and 2—who DHA estimates to be most likely to receive their vaccine from DOD rather than from a state-run facility or private provider. The target population includes eligible military servicemembers (those on active duty, members of the Selected Reserve including the National Guard, and members of the Coast Guard), military servicemembers who have retired and their dependent family members, dependent family members of active-duty servicemembers and of certain reserve component members, civilians, and contractors.
aThe number of doses administered is not equal to the total number of individuals fully and partially vaccinated because the Pfizer-BioNTech and Moderna vaccines for COVID-19 both require two doses for full vaccination, while the Janssen (Johnson & Johnson) vaccine requires a single dose.

Of the 875,707 individuals at least partially vaccinated, 489,703 were military servicemembers, comprising about 23 percent of the eligible military servicemembers in all phases. DHA officials stated that the winter holidays and weather temporarily slowed administration efforts in the first month after vaccinations began (mid-December 2020 through mid-January 2021). The pace has generally improved through March 2021.

Each DOD vaccination site may begin vaccinating individuals in lower tier phases at a different date due to differences in the proportion of individuals who are available within each phase at each location, according to DHA officials.

The DHA Director monitors vaccine plan implementation on a daily basis, including allotment, distribution, and administration, broken out by vaccine manufacturer, dose (initial and second), category of eligibility (e.g., service component, contractors, civilian employees, and other beneficiaries), and location. The Director also receives updates on public affairs activities, new information from the Centers for Disease Control and Prevention, and relevant clinical considerations, such as any adverse effects in DOD vaccine recipients reported to the Vaccine Adverse Event Reporting System (a national vaccine safety surveillance system overseen by the Centers for Disease Control and Prevention and FDA).

Challenges and lessons learned. DOD officials have identified a number of challenges to the efficient and timely vaccination of workforce personnel and dependents of servicemembers, and have taken corresponding corrective actions to address them.

Predictability of supply levels. According to DHA officials, during the first weeks of distribution in December 2020, some vaccine shipments arrived at receiving facilities unexpectedly and without tracking numbers from the Army Medical Materiel Agency. As a result, DHA officials stated that staff at vaccination sites became concerned about supply levels and initially held back doses from the initial shipments to conserve supply for second doses, rather than using them to administer first doses to other eligible personnel. Army officials stated that Pfizer had shipped vaccines to some locations during those initial weeks before providing tracking numbers, resulting in deliveries occurring before the Army Medical Materiel Agency could notify those sites. DHA officials communicated the concerns to the Army Medical Materiel Agency to improve distribution and they continue to monitor progress as shipments increase. For example, according to officials from the Army Medical Materiel Agency, they have since participated in DHA’s Operational Planning Team for vaccine distribution and administration, and have briefed the DHA Director on a daily basis. They stated that all vaccines have been delivered on time and without any losses.

Vaccine confidence. DOD encourages but does not require military servicemembers to receive a COVID-19 vaccine authorized for emergency use. [174] Senior DOD leaders and DHA officials emphasized to us that communication and transparency with their eligible population are paramount to increasing vaccine confidence. In particular, they stated that education about the benefits and low risk of the FDA-authorized COVID-19 vaccines is critical to expanding the vaccination campaign and thereby protecting the health of individuals. To these ends, DOD has implemented a public affairs campaign with approaches such as public service announcement videos to address topics of concern, a video message from the Secretary of Defense, updates to websites, social media, press releases and briefings, and media round tables. Senior DOD leaders and military health professionals were among the first to receive the vaccines after their FDA authorizations, which they promoted with media events.

According to senior DOD leaders, they believe that continuing to promote confidence in the FDA-authorized COVID-19 vaccines will help address some degree of hesitancy that may exist among military servicemembers just as with the general population. To that end, DOD leaders have used the term “vaccine acceptance” to categorize the proportion of the military servicemembers who received a vaccine compared with those eligible to receive it. However, “acceptance” suggests that individuals not counted in the ratio have actively declined or resisted vaccination, while there could be other reasons that they have not yet received a vaccine, such as insufficient supply in a certain location or because they were traveling or were on leave at the time they could have been vaccinated.

DOD officials stated that as long as the demand for vaccines exceeds available supply (projected to be the case through late spring or summer of 2021), they cannot reliably determine how many military servicemembers or others may have delayed vaccination or do not plan to be vaccinated. Individuals who show up for an appointment at a DOD vaccination site and decide not to request the vaccine after reviewing educational material are asked to record their decision on DHA Form 207–“COVID-19 Screening and Immunization Document.” However, DHA officials noted that this decision reflects a single point in time, and the individual may choose to receive the vaccine at a later date. Meanwhile, DHA officials stated that they are monitoring demographic trends among DOD vaccine recipients, and when supplies increase to meet or exceed demand, they expect to learn more about personnel who may have postponed or declined COVID-19 vaccination.

DOD officials involved in the vaccine distribution and administration process have been documenting lessons learned and sharing them among DOD vaccination sites, other federal agencies, and select foreign collaborators. For example, according to DHA officials, on the basis of lessons learned, they expedited procedures by having staff prepare paperwork and fill vaccine syringes from vials prior to the arrival of the individuals to be vaccinated. In addition, officials have found that using large facilities, such as gymnasiums and warehouses, makes it possible to administer vaccines to large numbers of individuals and observe them post-vaccination while adhering to social distancing requirements.

Agency Comments

We provided a draft of this enclosure to DOD and the Office of Management and Budget for review and comment. DOD provided technical comments on this enclosure, which we incorporated as appropriate. The Office of Management and Budget did not provide comments on this enclosure.

Methodology

To conduct this work, we reviewed DOD guidance and the most recent DOD data available as of March 2021 on COVID-19 cases and vaccines. We obtained COVID-19 case data from defense.gov/explore/spotlight/coronavirus and vaccine data from DHA. To assess the reliability of the data, we discussed them with agency officials, reviewed them for outliers or obvious errors, and reviewed relevant DOD documents. We determined that they were sufficiently reliable for the purposes of this enclosure but did not independently review them for accuracy.

We also interviewed DOD officials knowledgeable about COVID-19 vaccination efforts and reviewed publicly available DOD media reports, statements, and documents.

Contact information: Brenda S. Farrell, (202) 512-3604, farrellb@gao.gov

Defense Support of Civil Authorities

As COVID-19 cases have surged across the country in late 2020 and into early 2021, requests for the Department of Defense to provide personnel to support civil authorities have increased and focused on specialties, such as critical care nurses.

Entities involved: Department of Defense; Federal Emergency Management Agency, within the Department of Homeland Security; and Department of Health and Human Services

Key Considerations and Future GAO Work

We plan to continue to monitor how the Department of Defense (DOD) will support vaccine distribution and administration efforts as part of its Defense Support of Civil Authorities mission and the government-wide pandemic response.

Background

While DOD’s primary mission is to defend the nation, the department is often asked to play a prominent role supporting civil authorities and must be prepared to provide rapid response when called upon during disasters and declared emergencies (natural or man-made). DOD provides such support through its Defense Support of Civil Authorities mission, and is authorized to do so when requested by another federal agency, with approval from the Secretary of Defense, or when directed by the President. [175] DOD provides such support using federal military forces; DOD civilians and contract personnel; and DOD component assets, to include the National Guard, the U.S. Army Corps of Engineers, and the Defense Logistics Agency.

National Guard forces may provide support to civil authorities when ordered to active duty—commonly referred to as Title 10 duty status. When ordered to active duty, National Guard forces are funded and commanded by DOD. National Guard personnel may also be ordered to a duty status pursuant to Title 32 U.S.C. § 502(f)—commonly referred to as Title 32 duty status—by the President or Secretary of Defense and with the consent of the Governor. When operating in a Title 32 duty status, National Guard forces are funded by DOD and commanded by the state. The following figure shows the state and federal command relationship based on the National Guard’s or other forces’ status in supporting civil authorities.

State and Federal Command Relationship Regarding Defense Support of Civil Authorities

Congress appropriated approximately $1.5 billion through the CARES Act for Army and Air National Guard personnel and operations expenses incurred to prevent, prepare for, and respond to the coronavirus, domestically or internationally. [176] The approximately $1.5 billion was required to be obligated by September 30, 2020. According to USAspending.gov, as of November 30, 2020, the National Guard had obligated about $153.0 million and spent about $91.7 million of that appropriation from the Army and Air National Guards’ Personnel and Operation and Maintenance accounts. [177]

Section 13001 of the CARES Act provided DOD with the authority to transfer amounts appropriated to the department by the act to other applicable DOD appropriations for expenses incurred in preventing, preparing for, or responding to COVID-19, including in support of other federal departments and agencies, and state, local, and tribal governments. [178] As we noted in our September 2020 report, DOD officials stated that the total amounts appropriated to the National Guard in the CARES Act could not be fully obligated before they expired on September 30, 2020.

Amounts appropriated to the National Guard are not available to support state-level response activities. Moreover, National Guard support to the states for the COVID-19 response was reimbursed by FEMA and the states. Specifically, the initial mission assignments for Title 32 National Guard support were issued with 100 percent of the cost of support reimbursed by the federal government and no cost to the states. On August 3, 2020, the President issued memorandums extending the authorization of Title 32 status for National Guard troops supporting the COVID-19 pandemic through December 31, 2020. [179]

Consequently, amounts appropriated in the CARES Act to the National Guard in support of the states’ COVID-19 response for fiscal year 2020 were identified as available for transfer to other DOD appropriations for COVID-19-related priority activities. By September 30, 2020, DOD had transferred approximately $1.28 billion of the amounts appropriated to the Army and Air National Guard through the CARES Act to other DOD appropriations for COVID-related expenses (see fig.).

CARES Act Appropriations to the National Guard and Subsequent Transfers from the National Guard to Other DOD Accounts, Fiscal Year 2020

aCoronavirus Aid, Relief, and Economic Security (CARES) Act, Pub. L. No. 116-136, div. B, title III, 134 Stat. 281, 518 and 520 (March 27, 2020).

According to a DOD Comptroller official, the CARES Act amounts were transferred out of the four National Guard accounts to other DOD appropriation accounts as part of the department’s CARES Act reprogramming actions. The official further stated that the National Guard amounts were combined with other amounts identified for reprogramming and transferred to other DOD appropriations for use on COVID-19 expenses. Our analysis of DOD reprogramming documentation found that the department transferred amounts initially appropriated to Army and Air National Guard accounts in the CARES Act to a number of other DOD appropriation accounts (see table).
Department of Defense (DOD) Accounts That Received CARES Act Appropriations Transferred from National Guard Accounts

National Guard account with CARES Act amounts available for transfer

DOD appropriation receiving CARES Act amounts transferred from National Guard accounts

Army National Guard
  • National Guard Personnel, Army
  • Operation and Maintenance, Army National Guard
  • Military Personnel, Army
  • Military Personnel, Navy
  • Military Personnel, Marine Corps
  • Operation and Maintenance, Army
  • Operation and Maintenance, Navy
  • Other Procurement, Army
  • Reserve Personnel, Marine Corps
  • Research, Development, Test, and Evaluation, Army

Air National Guard
  • National Guard Personnel, Air Force
  • Operation and Maintenance, Air National Guard
  • Military Personnel, Air Force
  • Operation and Maintenance, Air Force
  • Operation and Maintenance, Navy
  • Operation and Maintenance, Navy Reserve
  • Operation and Maintenance, Marine Corps
  • Defense Working Capital Fund
Source: GAO analysis of Department of Defense (DOD) budget documents. I GAO-21-387

We reported on DOD’s reprograming actions in November 2020. According to a September 2020 DOD internal reprogramming action, $24.4 million was available for transfer from the Army National Guard Personnel account to the Army Research, Development, Test, and Evaluation account. The reprogramming action stated that the funds were needed to assess COVID-19 testing capability for the Army force and would be used to evaluate the viability and reliability of two COVID-19 testing systems in operational settings.

As another example, approximately $254.6 million of CARES Act amounts appropriated to the Air National Guard Personnel account were transferred to three other accounts, specifically Air Force Personnel ($157.8 million), Marine Corps Operation and Maintenance ($90.5 million), and Navy Reserve Operation and Maintenance ($6.3 million) in July 2020. According to the department’s internal reprogramming action document, the amounts transferred to the Marine Corps were needed to support temporary camps and contract lodging to ensure social distancing and a safe training environment for new recruits and officer candidates, among other things. [180]

Overview of Key Issues

DOD has faced increased demand for personnel to support civil authorities. According to DOD officials, demand for the department’s support of civil authorities has continued to increase as large portions of the country experienced surges in COVID-19 cases and the department began supporting new missions, as discussed in more detail below. On January 22, 2021, the new Secretary of Defense released a statement affirming the department’s continued commitment to aid the nation’s health care professionals.

DOD officials stated that from March 2020 through January 2021 the department received over 400 Federal Emergency Management Agency (FEMA) mission assignments and other requests for DOD support. According to DOD officials, as of late February 2021, the department had active mission assignments for active-duty personnel in 26 states and territories. For example, DOD personnel were supporting civilian health care providers at medical facilities in California, Arizona, Texas, and the Navajo Nation through February 2021. [181] Subsequently, officials from DOD and FEMA reported in February 2021 that additional assignments to support federally run vaccination centers using DOD active-duty forces were underway.

In late January 2021, DOD officials told us that 391 DOD medical personnel were providing support under FEMA mission assignments. However, that number increased significantly in February 2021 as the department began deploying personnel for the vaccination center missions. As of February 28, 2021, approximately 3,700 DOD active-duty personnel were providing assistance to the states under the COVID-19 response. [182]

In addition, the number of National Guard personnel supporting the COVID-19 pandemic response has also increased, following a period of decreased need in the fall of 2020. [183] Specifically, as of February 28, 2021, approximately 29,000 National Guard members were activated to support the COVID-19 response in all 50 states, 3 territories, and the District of Columbia. This total represents an increase of approximately 12,000 National Guard members put on orders to support the response since fall 2020; however, this is still below the peak of National Guard support provided in spring 2020, when approximately 40,000 members were on orders. According to FEMA’s January 2021 COVID-19 Initial Assessment Report, the response to COVID-19 is the first time Title 32 has been authorized for National Guard support at this scale and is the largest number of mission assignments ever issued for Title 32 support. [184]

The figure below shows DOD personnel totals supporting civil authorities by month from March 2020 through February 2021.

Department of Defense (DOD) Personnel Supporting Civil Authorities’ COVID-19 Response, March 2020 through February 2021

Note: Personnel totals are as of the end of each month.

DOD has received increased requests for specialized medical support. According to DOD officials, as more has become known about COVID-19, the types of support requested of and provided by DOD have changed and become more targeted. Officials stated that, as of January 2021, the states’ primary needs were for nurses, especially critical care nurses for intensive care units. [185] According to those officials, the need for more specialized medical support underscores a notable shift away from the requests for more general medical capabilities in the spring of 2020 when little was known about the virus or its treatment and the requests for assistance were not being evaluated all together. [186] DOD officials also stated that the department had to balance requests for critical care nurses to help ensure that sufficient numbers of this type of nurse was available at its own medical treatment facilities to handle trauma cases, among other things.

Subsequently, in February 2021, DOD officials stated that the department’s COVID-19 support efforts was shifting from augmentation of local medical capabilities to establishing and supporting federal vaccination sites in states, using both nonmedical and medical active-duty personnel. As part of this new line of effort, FEMA requested as many as 50 Type 1 teams and as many as 50 Type 2 teams from DOD to support the vaccination sites. [187]

As of March 2, 2021, more than 2,200 military medical and support personnel were deployed in teams to support the federal vaccine response to the COVID-19 pandemic. [188] More specifically, on February 16, 2021, the first team of 222 U.S. military personnel began supporting a Type 1 vaccination site at California State University, Los Angeles. [189] The team—consisting of active-duty Army personnel—was tasked with administering vaccinations and providing supervisory and pharmacy support for the site through March 26, 2021 (see fig.). According to a DOD official, the site is capable of administering up to 6,000 vaccinations a day. The department subsequently deployed additional teams ranging in size from 25 servicemembers to 222 servicemembers to locations in Florida, Georgia, Illinois, Michigan, New York, New Jersey, North Carolina, Ohio, Pennsylvania, Texas, and the U.S. Virgin Islands in late February and March. [190]

Department of Defense Personnel Provide COVID-19 Vaccination Support in Los Angeles, California (March 2021)

According to DOD officials, a number of factors—such as access to and training on state-level vaccination tracking systems and the overall supply of vaccine doses—had to be addressed before DOD’s involvement in the vaccination efforts could expand.

National Guard support has shifted to align with the evolving vaccination-related needs of the states, but members have continued to support broader COVID-19 missions.

According to the National Guard Bureau, demand for National Guard assistance is likely to continue due to vaccine distribution, the strain on the health care system, and continued unemployment. Throughout the surge in COVID-19 cases in late 2020 and early 2021, National Guard members continued to provide support to a range of broad missions. However, with the rollout and prioritization of vaccinations, National Guard members also began assisting civil authorities in the distribution and administration of vaccines throughout the states. As of January 2021, 30 states were utilizing National Guard personnel to administer vaccines to the civilian population.

National Guard members have continued to support the broader COVID-19 missions listed below.
  • Testing and screening. National Guard members in 42 states have continued to support state and local government testing and screening for COVID-19 cases, as of January 2021. For example, in December 2020, the Mississippi National Guard administered COVID-19 testing in communities and at long-term care and correctional facilities. This included staffing more than 34 drive-through testing sites per day in addition to providing personnel to serve as members of outbreak response teams.

Mississippi National Guard Members Supporting COVID-19 Testing throughout the State in 2020

  • Medical planning. National Guard members in 37 states have conducted medical planning, as of January 2021. For example, in December 2020, Rhode Island National Guard members worked with state agency partners to provide assistance in planning and coordination for the distribution of the COVID-19 vaccine.
  • Warehouse operations. National Guard members in 35 states have continued to perform tasks related to storing and distributing supplies and equipment in warehouses, as of January 2021. For example, in December 2020, Maine National Guard members conducted warehousing, inventory, and distribution efforts at Centers for Disease Control and Prevention receiving, staging, and storage facilities, while Kansas National Guard members conducted coordination efforts with the state health department at a Topeka warehouse facility.
  • Other missions. Throughout the COVID-19 pandemic response, National Guard members in a range of states have supported local long-term care facilities; assisted health departments with contact tracing and mapping; distributed personal protective equipment; collected COVID-19 specimens; and supported food banks by collecting and distributing food and supplies, among other things.

Agency Comments

We provided a draft of this enclosure to DOD and the Office of Management and Budget for review and comment. DOD provided technical comments on this enclosure, which we incorporated as appropriate. The Office of Management and Budget did not provide any comments on this enclosure.

Methodology

To conduct this work, we reviewed DOD documentation and the most recent information available as of March 2, 2021. We also interviewed DOD officials knowledgeable about COVID-19 response efforts. The data were provided to us by the DOD COVID-19 Task Force, which maintains the COVID-19 data of record for the department and reports them to senior DOD leaders. While we did not independently verify the accuracy of the data, we assessed the reliability of the data provided to us by checking for obvious errors or outliers, discussing the ongoing levels of DOD personnel support with knowledgeable DOD officials, and reviewing relevant documentation. We determined that the data were sufficiently reliable for the purposes of reporting the levels of personnel support provided by DOD. We also reviewed spending data from USAspending.gov through November 30, 2020.

Contact information: Diana Maurer, (202) 512-9627, maurerd@gao.gov

HHS COVID-19 Funding

As of February 28, 2021, the Department of Health and Human Services reported that it had obligated about $232 billion and expended about $148 billion of the approximately $324 billion in COVID-19 relief funds appropriated in the five COVID-19 relief laws enacted as of January 1, 2021—about 72 percent and 46 percent, respectively.

Entity involved: Department of Health and Human Services

Key Considerations and Future GAO Work

We will continue to examine the Department of Health and Human Services’ (HHS) use of COVID-19 relief appropriations contained in COVID-19 relief laws enacted to help fund the COVID-19 response, including appropriations in the American Rescue Plan Act of 2021, a sixth COVID-19 relief law enacted on March 11, 2021.

Background

HHS received approximately $324 billion in COVID-19 relief appropriations from the five COVID-19 relief laws enacted as of January 1, 2021, to assist the response to COVID-19 (see table below). [191]

Appropriations to HHS for COVID-19 Response from the Five COVID-19 Relief Laws Enacted as of January 1, 2021

Legislation

Appropriations
($ millions)

Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (Pub. L. No. 116-123)

6,497.0

Families First Coronavirus Response Act (Pub. L. No. 116-127)

1,314.0

CARES Act (Pub. L. No. 116-136)

142,833.4

Paycheck Protection Program and Health Care Enhancement Act (Pub. L. No. 116-139)

100,000.0

Consolidated Appropriations Act, 2021 (Pub. L. No. 116-260) a

73,175.0

Total

323,819.4
Source: Department of Health and Human Services (HHS) data. | GAO-21-387

Note: The Department of Health and Human Services (HHS) reported that, of its total appropriations for COVID-19 relief, the agency transferred $289 million to the Department of Homeland Security, and $300 million are not available until HHS has taken certain actions.
aThis amount reflects appropriations provided in Divisions M and N of the Consolidated Appropriations Act, 2021 that are specifically designated for COVID-19 relief. An additional $638 million in COVID-19 relief funds were appropriated under Division H to the Administration for Children and Families, an agency within HHS, to prevent, prepare for, and respond to the coronavirus, for necessary expenses for grants to carry out a Low-Income Household Drinking Water and Wastewater Emergency Assistance Program. However, these funds were not included in the HHS-reported data on HHS COVID-19 relief appropriations, obligations, and expenditures, as HHS noted that it is not considered COVID-19 relief funding for USAspending.gov reporting purposes.

Overview of Key Issues

As of February 28, 2021, of the approximately $324 billion in COVID-19 relief funds appropriated, HHS reported that it had obligated about $232 billion and expended about $148 billion—about 72 percent and 46 percent, respectively (see figure below).

HHS’s Reported COVID-19 Relief Appropriations, Obligations, and Expenditures from COVID-19 Relief Laws, as of February 28, 2021

Note: These amounts reflect appropriations provided in Divisions M and N of the Consolidated Appropriations Act, 2021 that are specifically designated for COVID-19 relief.

In the following table, we list HHS appropriations, obligations, and expenditures by HHS agency that HHS reported as of February 28, 2021, from the five COVID-19 relief laws enacted as of January 1, 2021.
Department of Health and Human Services-Reported COVID-19 Relief Appropriations, Obligations, and Expenditures from Five COVID-19 Relief Laws, by Agency or Key Fund, as of February 28, 2021

Agency or key fund

Appropriations
($ millions)

Obligations
($ millions)

Expenditures
($ millions)

Administration for Children and Families

16,524.0

16,117.5

3,517.7

Administration for Community Living

1,480.0

1,380.0

801.3

Agency for Toxic Substances and Disease Registry

12.5

12.4

4.1

Centers for Disease Control and Prevention (CDC)

15,250.0

7,175.1

1,682.4

Centers for Medicare & Medicaid Servicesa

200.0

119.9

35.1

Food and Drug Administration (FDA)

196.0

45.5

20.8

Health Resources and Services Administration (HSRA)

1,320.0

1,319.4

998.3

Indian Health Service (IHS)

1,096.0

779.3

690.7

National Institutes of Health (NIH)

3,031.4

981.7

335.5

Public Health and Social Services Emergency Fund (PHSSEF)b

280,034.5

203,086.0

139,564.6

Office of the Assistant Secretary for Preparedness and Response c

15,695.1

10,507.8

6,436.4

Biomedical Advanced Research and Development Authority c

37,470.4

24,131.8

4,242.0

Provider Relief Fund c

178,000.0

128,601.4

120,151.7

Testing for uninsured c

2,000.0

1,968.8

1,967.2

CDC c

1,000.0

393.2

181.4

FDA c

22.0

0.4

0.3

HRSA c

979.8

971.4

617.4

IHS c

790.0

18.7

0.0

NIH c

1,806.0

1,011.6

351.0

Office of Inspector General c

12.0

2.7

2.4

Other PHSSEF c

42,259.2

35,478.2

5,614.8

Substance Abuse and Mental Health Services Administration

4,675.0

1,109.0

85.6

Grand Total

323,819.4

232,125.8

147,736.1
Source: Department of Health and Human Service (HHS) data. | GAO-21-387

Note: HHS reported that of the total COVID-19 relief appropriations the agency transferred $289 million to the Department of Homeland Security, and that $300 million in appropriations are not available until HHS takes certain actions. HHS’s reported appropriations specifically designated for COVID-19 relief in the Consolidated Appropriations Act, 2021 (Pub. L. No. 116-260) reflect only appropriations provided under Divisions M and N.
aThese amounts do not reflect Medicaid and Medicare expenditures. As of February 28, 2021, COVID-19-related federal Medicaid expenditures totaled approximately $33 billion, or 7 percent of total federal spending on Medicaid services for January 2020 through February 2021. In addition, the Congressional Budget Office estimated that some provisions of COVID-19 relief laws would affect Medicare payments. For example, the Congressional Budget Office estimated that provisions in Division N of the Consolidated Appropriations Act, 2021 will increase Medicare payments to providers by about $6 billion in 2021 through 2022.
bPHSSEF is an account though which funding is provided to certain HHS offices, such as the Office of the Assistant Secretary for Preparedness and Response. Amounts have been appropriated to this fund for the COVID-19 response to support certain HHS agencies and response activities. For example, NIH received about $1.8 billion in transfers from the PHSSEF, and this amount is not included in the approximately $3 billion appropriated directly to NIH.
cThe italicized amounts are subtotals of the PHSSEF and are already reflected in the total 280,034.5 billion listed for the PHSSEF. Italicized amounts listed under the PHSSEF appropriations column are HHS allocations based on appropriations made in the COVID-19 relief laws, and approved allotment decisions made by HHS in coordination with the Office of Management and Budget. Some amounts were appropriated to the PHSSEF for transfer to specified HHS agencies. The Provider Relief Fund reimburses eligible health care providers for health care-related expenses or lost revenues that are attributable to COVID-19. Provider Relief Fund expenditures also may be referred to as disbursements.

HHS reported allocations, obligations, and expenditures of appropriations from the five COVID-19 relief laws for a variety of COVID-19 response activities, including activities to support testing, the development of vaccines or therapeutics, and the acquisition of critical supplies. Across these activities, the percentage of allocated funds that had been expended as of February 28, 2021, ranged from about 98 percent for testing for the uninsured to about 9 percent for support to state, local, territorial, and tribal organizations, which includes, in part, recent allocations from the fifth COVID-19 relief law, enacted on December 27, 2020.

The following table provides HHS’s reported allocations, obligations, and expenditures by selected key response activity.
Department of Health and Human Services-Reported Allocations, Obligations, and Expenditures of COVID-19 Relief Funds from five COVID-19 Relief Laws, by Selected Key Response Activity, as of February 28, 2021

Key response activity

Allocations
($ millions)

Obligations
($ millions)

Expenditures
($ millions)

Health centersa

2,020.0

2,018.1

1,439.7

Head Start

1,000.0

744.5

352.6

Provider Relief Fundb

178,000.0

128,601.4

120,151.7

Testing for uninsured

2,000.0

1,968.8

1,967.2

Support to state, local, territorial, and tribal organizations for preparedness

37,392.1

35,529.5

3,442.3

Strategic National Stockpile

13,919.9

8,986.4

5,232.2

Telehealth

167.5

48.2

16.2

Testing

12,084.0

5,396.5

3,095.1

Vaccines

23,410.1

16,973.2

2,932.3

Drugs and therapeutics

7,628.4

7,014.2

1,246.0

Diagnostics research and development

3,100.6

1,569.9

474.2

Global disease detection and emergency response

800.0

306.3

84.3

Other response activitiesc

42,296.8

22,968.8

7,302.3

Total

323,819.4

232,125.8

147,736.1
Source: Department of Health and Human Services (HHS) data. | GAO-21-387

Notes: The selected response activities represent examples of certain targeted activities that fall within particular HHS agencies, such as funding for health centers or Head Start, as well as broader categories of response activities that may span HHS agencies, such as testing-, vaccine-, and therapeutics-related response activities. HHS reported allocations, obligations, and expenditures for these activities based on the primary programmatic recipient organization of the funds, although some activities apply to multiple categories. For example, certain funds in the “support to state, local, territorial, and tribal organizations for preparedness” category were provided for testing but are not reflected in the “testing” category. According to HHS officials, the allocations reported for the key activities above are based on amounts appropriated for these activities in the COVID-19 relief laws, and on approved allotment decisions made by HHS in coordination with the Office of Management and Budget. With respect to the Consolidated Appropriations Act, 2021, the amounts reflect only appropriations specifically designated for COVID-19 in Divisions M and N of the act.
aHealth centers provide a comprehensive set of primary and preventative health care services to individuals regardless of their ability to pay. Approximately $17 million of this funding is for Health Center Program look-alikes, which are centers that do not receive Health Center Program funding but meet program requirements.
bThe Provider Relief Fund reimburses eligible health care providers for health care-related expenses or lost revenues that are attributable to COVID-19. Provider Relief Fund expenditures may also be referred to as disbursements.
cAccording to HHS, other response activities include Centers for Disease Control and Prevention agency-wide activities and program support; health care preparedness and response activities; and certain activities conducted by the National Institutes of Health, among other activities.

Agency Comments

We provided HHS and the Office of Management and Budget (OMB) with a draft of this enclosure. HHS and OMB provided technical comments on this enclosure, which we incorporated as appropriate.

Methodology

We requested, and HHS provided, data on appropriations, allocations, obligations, and expenditures of COVID-19 relief funds by HHS agency and by key response activity, as of February 28, 2021. We also reviewed appropriation warrant information provided by the Department of the Treasury as of January 31, 2021. To assess the reliability of the data reported by HHS, we reviewed HHS documentation, Treasury appropriation warrant information, and information from the federal spending database, USAspending.gov, as well as HHS’s spending database, taggs.hhs.gov, and we determined that the HHS reported data were sufficiently reliable for the purposes of our reporting objective. [192] We also reviewed the five COVID-19 relief laws enacted as of January 1, 2021, to assist the response to COVID-19.

Contact information: Carolyn L. Yocom, (202) 512-7114, yocomc@gao.gov

Domestic Medical Product Manufacturing

Multiple federal agencies have efforts to enhance domestic manufacturing of medical products in response to the COVID-19 pandemic, and the federal government has recently initiated key steps to coordinate these efforts.

Entities involved: Department of Commerce, including the Bureau of Industry and Security and National Institute of Standards and Technology; Department of Defense; Department of Health and Human Services, including the Food and Drug Administration and the Office of the Assistant Secretary for Preparedness and Response; Department of Homeland Security, including the Federal Emergency Management Agency; Office of Management and Budget; U.S. International Development Finance Corporation

Key Considerations and Future GAO Work

The COVID-19 pandemic has highlighted the need to ensure a resilient U.S. supply chain for all medical products—drugs, biologics, and medical devices. One strategy to do so is to manufacture more medical products in the U.S. Enhancing domestic manufacturing of medical products is complex though, involving many different types of supplies and coordination of multiple federal agencies and the private sector.

In January 2021, we reported that the federal government had taken steps intended to create resilient domestic drug supply chains. However, we found that federal agencies did not have complete and accessible information to identify drug supply chain vulnerabilities or the manufacturing sources of drugs and their components. We recommended that the Food and Drug Administration (FDA) should obtain such information, including by working with manufacturers and other federal agencies and, if needed, seek authority to do so. FDA said that it would consider our recommendation as it continues efforts to enhance relevant authorities and close data gaps.

The federal government instituted many efforts to expand domestic production to respond to the COVID-19 pandemic. However, the dynamic environment and the shifting of responsibilities, raises questions about the federal government’s longer term plan for coordination and leadership.

The new administration took initial actions beginning in January 2021 to coordinate federal efforts to enhance domestic manufacturing, including directing federal agencies to develop a strategy for a resilient medical product supply chain by July 2021. We will continue to monitor these and other efforts to create a more resilient supply chain.

Background

The manufacturing of medical products has become an increasingly global enterprise over the past 30 years due in part to lower costs and fewer environmental regulations associated with overseas production, and other incentives. In particular, manufacturers of certain medical products, such as personal protective equipment (PPE) and generic drugs, have derived significant cost savings by manufacturing their products outside the U.S, which may also benefit consumers through lower prices for products. [193]

The COVID-19 pandemic has further increased interest in enhancing domestic manufacturing, also known as industrial base expansion, as demand and supply chain disruptions severely affected the availability of certain medical products, particularly PPE, that were coming from overseas. By increasing the availability of medical products manufactured in the U.S., the federal government hopes to strengthen national security by decreasing U.S. dependence on foreign sources, to respond more quickly and efficiently during current and future emergencies, and ultimately enhance the resiliency of the U.S. medical product supply chain.

However, the federal government faces many challenges with enhancing domestic manufacturing capacity. For example:
  • Industry associations have indicated that stringent environmental regulations, the cost and time needed to build facilities, and acquiring knowledgeable staff may serve as challenges to medical product manufacturing in the U.S.
  • Although federal purchasers are generally required to prioritize domestically manufactured products, federal purchasing alone is not a sufficient incentive for manufacturers to increase domestic production. Federal purchasers, such as the Department of Defense (DOD) and Department of Veterans Affairs (VA), make up about five percent of the U.S. commercial market, according to officials from DOD and the Office of the Assistant Secretary of Preparedness and Response (ASPR), within the Department of Health and Human Services (HHS).

Overview of Key Issues

Federal efforts to expand domestic production of medical products have increased in response to the COVID-19 pandemic. Multiple federal agencies have efforts, which include funding domestic manufacturing capacity, procuring domestically manufactured medical products, and promoting advanced manufacturing technology.

Funding domestic manufacturing capacity. The federal government has utilized CARES Act funding and Defense Production Act (DPA) authorities to directly fund manufacturers to increase production of PPE, drugs, and other medical supplies during the COVID-19 pandemic. [194] For example:
  • DOD and HHS awarded about $2.3 billion to domestic manufacturers to increase production of medical products, including PPE, drugs, and vaccine, ventilator, and testing materials, as of February 2021. (See the Defense Production Act enclosure for more detailed information about these awards.)
  • The U.S. International Development Finance Corporation, under DPA authority delegated to it, announced that it would award loans to U.S. private sector projects that supply resources or strengthen relevant supply chains needed to respond to the COVID-19 pandemic. [195] In November 2020, for example, this agency conditionally approved a $590 million loan to ApiJect to help build out infrastructure in North Carolina to package drugs and vaccines.
  • ASPR, through the Biomedical Advanced Research and Development Authority (BARDA), also made several awards to increase domestic production of medical products, including a May 2020 contract to Phlow Corporation for up to $812 million to manufacture drug ingredients needed during the COVID-19 response and future public health emergencies.

Federal procurement of domestically produced medical supplies. Recent Executive Orders, which are interrelated with existing federal acquisition requirements that preference U.S. made products, have further directed federal agencies to maximize the purchase of domestically manufactured goods. [196]
  • In August 2020, the Executive Order on Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States directed federal agencies to develop procurement strategies to purchase domestically sourced medical supplies and drugs. [197] This Order encourages agencies to take advantage of existing procurement authorities to limit competition, when permitted, to maximize the procurement of essential medicines, medical countermeasures, and critical inputs produced in the U.S. [198]
  • In January 2021, the Executive Order on Ensuring the Future Is Made in All of America by All of America’s Workers directed the federal government to consider amendments to the Federal Acquisition Regulation that would, among other things, increase the numerical threshold for domestic content requirements, under the implementation of the Buy American Act. [199] It also directed federal agencies to report on implementation of and compliance with domestic preference laws governing federal procurement, including the Buy American Act, and make recommendations on maximizing the use of products made in the U.S.

Federal agencies’ promotion of advanced manufacturing in the U.S. Several federal agencies have longstanding programs to promote technological advances in the domestic manufacturing of drugs and medical countermeasures, including PPE. In some cases, these programs have also assisted in the COVID-19 response.
  • In 2012, HHS established the Centers for Innovation in Advanced Development and Manufacturing to develop and manufacture medical countermeasures in the U.S. [200] In January 2021, one of these centers announced that production had begun for two separate COVID-19 vaccine candidates in Texas. [201]
  • Established in 2014, Manufacturing USA is a network of manufacturing institutes working with participating federal agencies, including the Department of Commerce (Commerce), DOD, and the Department of Energy. According to Commerce officials, each institute is a unique public-private partnership jointly funded by government and private industry that promotes U.S. advanced manufacturing through collaboration with private industry and academia. For example, in May 2020, Commerce awarded $8.9 million to the National Institute for Innovation in Manufacturing Biopharmaceuticals to, in part, identify reliable domestic supply chains for the production of respirators and PPE, and build flexible manufacturing capabilities that allow for the quick scale-up in production of biologic therapies and essential medical products.

    Additionally, America Makes, which is a DOD-sponsored Manufacturing USA institute, partnered with FDA, VA, and the National Institutes of Health (NIH) to create an online forum of manufacturers with 3D printing capabilities, designers willing to share 3D print designs, and health care providers in need of PPE, according to the National Institute of Standards and Technology (NIST), within Commerce. NIST officials explained that VA helps to test the designs, which then may be reviewed by FDA. According to NIST, the manufacturing community used validated models posted on the NIH 3D Print Exchange, with an estimated production of millions of facemasks, face shields, and parts aligned to the needs of the supply chain crises.
  • Also established in 2014, FDA’s Emerging Technology Program seeks to promote innovation in drug manufacturing, such as through advanced manufacturing and continuous manufacturing. In January 2021, FDA and NIST signed a memorandum of understanding to collaborate on increasing resilience in the U.S. medical supply chain and advancing domestic manufacturing of drugs and medical devices.

Recent federal actions aim to increase coordination of efforts to enhance domestic medical product manufacturing. In response to the COVID-19 pandemic, multiple federal actions were initiated to coordinate efforts to enhance domestic medical product manufacturing. (See figure below.)

Selected Federal Entities Involved in the Coordination of Domestic Manufacturing Capacity Efforts in Response to the COVID-19 Pandemic

  • In March 2020, HHS established the Supply Chain Task Force, later renamed the Supply Chain Advisory Group, which includes detailees from the Federal Emergency Management Agency (FEMA) and DOD, according to Supply Chain Advisory Group officials. [202] The Advisory Group was established to maximize the nationwide availability of supplies needed for the COVID-19 response. Supply Chain Advisory Group officials said the Advisory Group assists ASPR with identifying targets for domestic production capacity for various medical supplies. Since the Supply Chain Advisory Group does not have procurement authority, the Defense Assisted Acquisition Cell, within DOD, awards funding to domestic manufacturers to increase their production capacity, according to FEMA and ASPR officials. [203] The Supply Chain Advisory Group transitioned its responsibilities, including those related to enhancing domestic manufacturing, to ASPR in late January 2021, according to ASPR and DOD officials. Supply Chain Advisory Group officials said that they are continuing to assist ASPR with these responsibilities and anticipate doing so through mid-March 2021.

    In our September 2020 CARES Act report, we noted that DOD planned to transition their contract management responsibilities, including awarding domestic production expansion projects, to ASPR, within HHS, that month. In this report, we recommended that HHS, in coordination with FEMA, should immediately document roles and responsibilities for supply chain management functions transitioning to HHS. HHS disagreed, noting, among other things, the work that the departments had done to manage the medical supply chain and increase supply availability. We maintain the importance of this recommendation.
  • Separately, beginning in June 2020, ASPR led another work group, which was focused on modernizing the Strategic National Stockpile (SNS) and addressing supply chain vulnerabilities for critical drugs and medical supplies, called the Logistics, Supply Chain, Next Generation SNS Workgroup. This workgroup ended in September 2020, but ASPR’s work to expand domestic manufacturing work stream continued, according to ASPR officials. (See our Strategic National Stockpile and Medical Supply Chain enclosure for more details about the SNS).

    In Fall 2020 ASPR drafted a national supply chain strategy that includes the goal of increasing domestic manufacturing capabilities of medical countermeasures and PPE, referred to as the “SNS 2.0 Strategy – Modernize the SNS.” ASPR officials acknowledged that some aspects of the strategy are beyond its mission and that the agency would need to involve other HHS components to implement it fully. Due to the change in administration in 2021, issuance of the SNS 2.0 Strategy had been paused, according to officials, who noted that any ASPR strategy or other coordination efforts will align with the priorities outlined by the new administration.

    In December 2020, the Supply Chain and Industrial Base Assurance Steering Committee formed to continue ASPR’s work to expand domestic manufacturing. In particular, the Steering Committee will establish ASPR’s long-term strategy for a resilient supply chain for medical countermeasures, including by promoting domestic manufacturing. Additionally, ASPR plans to combine these responsibilities with those that were transferred from the Supply Chain Advisory Group. According to ASPR officials, ASPR also created an office focused on industrial base expansion in January 2021.
  • In September 2020, a White House task force on medical onshoring, which was led by the Office of Trade and Manufacturing Policy, started to coordinate the federal government approach to enhance domestic manufacturing, according to ASPR officials. The task force focused on implementation of the provisions of the Executive Order on Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the U.S. across the federal government, which included directing federal agencies to develop procurement strategies to increase U.S. manufacturing of medical supplies, among other things. Officials said that the efforts included the key federal agencies mentioned in the Executive Order, including FDA, DOD, and Commerce, but were unable to provide us with any additional details about the task force’s activities. According to ASPR officials, this task force was disbanded in November 2020 due to the change in administration.

Federal Coordination of Advanced Manufacturing

Federal coordination of advanced manufacturing was occurring prior to the COVID-19 pandemic. The America COMPETES Reauthorization Act of 2010, as amended, mandates the coordination of federal programs and activities that focus on advanced manufacturing programs, including those that pertain to enhancing domestic manufacturing. Specifically, the Committee on Technology under the National Science and Technology Council within the Executive Office of the President is responsible for planning and coordinating efforts to expand advanced manufacturing in the U.S., including for medical products. Members of the Council include the Department of Health and Human Services, the Department of Defense, and the Department of Commerce, among others. In 2018, the Council released a strategic plan, which included an objective to assure access to medical products through domestic manufacturing as part of its efforts to advance the technologies around medical product manufacturing.

Source: GAO analysis of 2018 report by the National Science and Technology Council and Pub. L. No. 111-358, 124 Stat. 3982 (2011) (codified in pertinent part, as amended, at 42 U.S.C. § 6622).| GAO-21-387

The new administration proposed additional actions to coordinate domestic manufacturing efforts for both the COVID-19 pandemic response and the longer term that may enhance federal coordination efforts beginning in late January 2021. Specifically, the White House
  • created the position of COVID-19 Response Supply Coordinator who is tasked with coordinating federal agencies involved in acquisition, supply, and expansion of domestic manufacturing to ensure a sustainable pandemic supply chain.
  • issued an Executive Order on A Sustainable Public Health Supply Chain directing federal agencies to present to the President a Pandemic Supply Chain Resilience Strategy. [204] The Order directs DOD, HHS, and the Department of Homeland Security (DHS), among others, to develop a strategy to design, build, and sustain a long-term capability in the U.S. to manufacture supplies for future pandemics and biological threats. According to ASPR officials, they have begun to coordinate with HHS, DOD, and DHS to develop the strategy. The strategy is to be completed by July 2021.
  • issued an Executive Order on America’s Supply Chains directing specified federal agencies to complete reports, including: (1) by June 2021, a review of supply chain risks and policy recommendations addressing them, including for HHS to report on the risks for drugs and active pharmaceutical ingredients; and (2) by February 2022, a report on the specified aspects of the supply chain, including for HHS to report on the supply chains for the public health and biological preparedness industrial base, such as by identifying the manufacturing or other capabilities needed to produce critical medical products, and assessing U.S. manufacturing capacity and gaps in domestic manufacturing capabilities. [205] These reports are to complement the ongoing work occurring for the A Sustainable Public Health Supply Chain Executive Order. The Assistant to the President for National Security Affairs and the Assistant to the President for Economic Policy are to coordinate the various federal agencies’ response to this Executive Order.
  • issued an Executive Order on Ensuring the Future Is Made in All of America by All of America’s Workers, which established the Made in America Office within the Office of Management and Budget (OMB) to further the Administration’s policy to use federal awards and procurements to maximize domestic manufacturing. [206] OMB officials indicated that efforts to implement the Executive Order are underway, but the Made in America Director had not yet been appointed as of February 2021. The office will assist the Director of OMB in reviewing and approving the waivers that federal agencies use to purchase products based on exemptions from federal acquisition regulations establishing a preference for domestic purchasing, including the Buy American Act provisions.

Enhancing domestic manufacturing is a complex endeavor involving multiple federal agencies and efforts. Since the COVID-19 pandemic, the number of actions to enhance domestic manufacturing has increased and some agency officials were unclear what entity, if any, was coordinating these efforts. In situations such as these, our key practices for interagency coordination, such as clarifying leadership roles and responsibilities and outlining how leadership will be sustained over the long term, may help ensure effective implementation and reduce the potential for duplication, overlap, and fragmentation. Several of the recent initial actions federal agencies are taking have the potential to enhance coordination and align with our best practices, but these efforts are all still in the early stages of development and we will continue to monitor them in our future work.

Agency Comments

We provided a draft of this enclosure to HHS, DOD, DHS, Commerce, and OMB; none of the agencies provided comments on this enclosure.

Methodology

To identify federal efforts to enhance domestic manufacturing of medical products and the coordination of such efforts, we reviewed federal agency documents and plans. We also received written responses and interviewed officials from ASPR, Commerce (Bureau of Industry and Security and NIST), DOD, FEMA, FDA, OMB, and the U.S. International Development Finance Corporation about their coordination of domestic manufacturing efforts in response to the COVID-19 pandemic and for advanced manufacturing.

Contact information: Mary Denigan-Macauley, (202) 512-7114, deniganmacauleym@gao.gov

Related Product

Managing for Results: Key Considerations for Implementing Interagency Collaborative Mechanisms. GAO-12-1022 . Washington D.C.: September 27, 2012.

Emergency Use Authorizations for Medical Devices

During the COVID-19 pandemic, the Food and Drug Administration issued emergency use authorizations to temporarily increase supply of certain medical devices, such as personal protective equipment. Stakeholders—e.g., manufacturers and users of products with emergency use authorization—have raised concerns about inconsistent guidance from agencies that outline permissible use of these devices, and the timeline and process for transitioning away from such devices as the pandemic ends.

Entities involved: Centers for Disease Control and Prevention and Food and Drug Administration, within the Department of Health and Human Services; Occupational Safety and Health Administration, within the Department of Labor

Recommendations for Executive Action

The Secretary of Health and Human Services should ensure that the Food and Drug Administration and the Centers for Disease Control and Prevention work with the Assistant Secretary of Labor for Occupational Safety and Health to develop a process for sharing information to facilitate decision-making and guidance consistency related to devices with emergency use authorization. The Department of Health and Human Services concurred with this recommendation.

The Assistant Secretary of Labor for Occupational Safety and Health should work with the Food and Drug Administration and the Centers for Disease Control and Prevention to develop a process for sharing information to facilitate decision-making and guidance consistency related to devices with emergency use authorization. The Department of Labor concurred with this recommendation.

As the Food and Drug Administration develops a transition plan for devices with emergency use authorizations, the Commissioner should specify a reasonable timeline and process for transitioning authorized devices to clearance, approval, or appropriate disposition that takes into account input from stakeholders. The Department of Health and Human Services concurred with this recommendation.

Key Considerations and Future GAO Work

Emergency use authorizations (EUA) allow for the temporary use of unapproved medical products when the Secretary of Health and Human Services declares circumstances exist to justify their emergency use. [207] These authorized medical products have been instrumental in increasing needed supply of certain devices—such as personal protective equipment (PPE)—during the COVID-19 pandemic response, according to Food and Drug Administration (FDA) officials and stakeholder associations we interviewed. However, we identified instances of inconsistencies between device use permitted by certain FDA EUAs and device guidance from the Centers for Disease Control and Prevention (CDC) and the Occupational Safety and Health Administration (OSHA). Such inconsistencies led to confusion and hesitancy among providers about using devices with EUAs, according to provider association officials, and may have undermined the use of these critical medical products early in the pandemic. Developing an interagency process for sharing information would help to facilitate decision-making and guidance consistency.

Officials representing health care providers, device manufacturers, and distributors also raised a number of concerns about what will happen to authorized devices after the declarations permitting their use for COVID-19 end. A plan for devices with EUAs that specifies a reasonable timeline and process for transitioning away from their use, taking into account stakeholder concerns, will help ensure a smooth transition.

In November 2020, we reported on FDA’s use of EUAs for other types of products for COVID-19—specifically, EUAs for therapeutics to treat COVID-19 and vaccines to prevent the disease. We recommended that FDA increase the transparency of its decisions related to EUAs for these products. Since our report, FDA has taken action to address our recommendation and we consider the recommendation closed.

We have additional ongoing work examining EUAs for COVID-19 diagnostic and antibody tests. Therefore, this enclosure focuses on medical devices other than tests, including PPE, decontamination systems, ventilators, infusion pumps, respiratory assistance devices, and remote patient monitoring devices, among others.

Background

Medical devices used for COVID-19. Medical devices, such as PPE and ventilators, may be necessary to provide medical care to patients during a pandemic such as COVID-19. See figure below for examples of certain devices used during the COVID-19 pandemic.

Examples of Medical Devices Used for COVID-19

Note: Tests are also devices used for detecting and diagnosing COVID-19; however, tests are outside the scope of this review.

Device marketing and EUA process. Generally, before a medical device can be marketed in the U.S., it must be approved or cleared by FDA. [208] While the amount of evidence required to meet the applicable FDA standard varies by the level of risk the device poses to patients or users, high-risk devices generally require FDA premarket review and approval to determine whether the device meets the statutory standard of reasonable assurance of safety and effectiveness for its intended use. Moderate-risk and some lower-risk devices may require premarket notification—also known as 510(k) clearance. [209]

The Secretary of Health and Human Services may declare that circumstances, prescribed by statute, exist justifying the authorization of emergency use of certain medical products, including devices. [210] For COVID-19, the Secretary issued three declarations in February and March 2020 permitting FDA to authorize the emergency use of different medical devices. [211] Once an EUA declaration has been made, FDA may temporarily authorize the emergency use of unapproved medical products or unapproved uses of approved medical products through EUAs, provided certain statutory criteria are met. [212] Prior to the COVID-19 pandemic, FDA had issued EUAs for certain respirators during the H1N1 pandemic.

Reissuing and revoking EUAs. FDA is required to periodically review the circumstances and appropriateness of EUAs it has issued. [213] FDA may revise an EUA—e.g., by reissuing the EUA with changes—or revoke an EUA if the circumstances that led to the EUA declaration no longer exist, the criteria for issuance are no longer met, or reissuance or revocation is appropriate to protect public health or safety. For example, FDA may reissue an EUA if there is a material change in the risk-benefit assessment based on evolving understanding of the disease or condition or availability of authorized devices. In general, an EUA will remain in effect for the duration of the EUA declaration unless revoked at an earlier date.

EUA declarations advanced notice. The Secretary of Health and Human Services is required to provide advance notice that EUA declarations will be terminated and must consult with the manufacturers of any authorized products regarding appropriate disposition of the products if authorizations cease to be effective due to termination of the declarations. [214]

Other agencies also responsible for ensuring safe and effective use of certain devices, such as PPE. CDC’s National Institute for Occupational Safety and Health (NIOSH) studies and makes recommendations focused on worker safety and health. As part of this effort, the agency provides a testing, approval, and certification program, assuring respirators used in the workplace meet certain standards. For example, NIOSH-approved “N95” respirators are proven to filter at least 95 percent of airborne particles. [215] In response to the COVID-19 pandemic, CDC released crisis capacity strategies with recommendations for optimizing supplies of PPE, such as limited re-use of respirators or use of non-NIOSH approved respirators when alternatives are not available.

The Department of Labor’s (DOL) OSHA helps ensure safe and healthy conditions for workers by setting mandatory workplace safety and health standards and conducting inspections to enforce those standards. [216] One such standard requires that employers provide respirators to employees exposed to certain respiratory hazards, and take steps to ensure their proper use, including by using NIOSH approved respirators. In response to the COVID-19 pandemic, OSHA has issued industry-specific voluntary guidance for employers on COVID-19-related precautions, as well as other actions.

Overview of Key Issues

EUAs issued, reissued, and revoked for medical devices during COVID-19. FDA has issued 55 EUAs for medical devices since March 2020, as of March 10, 2021. These include 46 EUAs for individual devices as well as nine umbrella EUAs—a new EUA approach FDA developed for COVID-19 that authorizes certain classes of devices for emergency use rather than individual models. [217] As part of FDA’s periodic reviews of EUAs, the agency has reissued 16 of these 55 EUAs issued since March 2020 and revoked three of them.

EUAs for individual devices. As of March 10, 2021 FDA has issued 46 EUAs for COVID-19 for individual devices, each covering a specific product. It has revoked one EUA for these devices and reissued 12 of them. See table for the number of EUAs issued and reissued by individual medical device type.
Number of Emergency Use Authorizations (EUA) Issued and Reissued for Individual Devices by Device Category for COVID-19, as of March 10, 2021

Device category

Number of EUAs

Number of EUAs reissued a

Number of EUAs revoked

Personal protective equipment (PPE)

6

1

0

Decontamination systems for PPE

15

10

1

Remote patient monitoringb

5

0

0

Respiratory assistance

5

0

0

Blood purification

4

0

0

Continuous renal replacement therapy and hemodialysis

3

0

0

Infusion pumps

1

0

0

Other devicesc

7

1

0

Total

46

12

1
Source: GAO analysis of data from the Food and Drug Administration’s (FDA) website and information obtained from agency officials. | GAO-21-387

Note: We reviewed documentation made publicly available by FDA, including authorization and reissuance letters and information on FDA’s website, to determine the information in this table.
aSome EUAs were reissued multiple times while others were reissued once. The count in this column reflects the number of EUAs FDA reissued at least once.
bFDA’s website lists six EUAs under this category. However, one Patient Isolation Treatment Unit EUA is identical to an EUA found under the PPE category. To avoid duplication, this EUA is only counted once under the PPE category due to its primary use as a protective barrier.
cOther medical devices consist of devices that provide life support to severely ill patients through external oxygenation (e.g., artificial lung and heart devices), conduct predictive screening for providers to anticipate which patients in intensive care units will be likely to experience low blood pressure or breathing difficulty, assist patients’ heart function through ventricular support systems, and help reduce COVID-19 transmission (e.g., non-surgical face masks).

Our review of FDA’s EUA documentation indicates that the majority of reissued individual EUAs were for decontamination units. This was primarily due to new information FDA received regarding respirators rather than due to issues surrounding the decontamination units themselves, according to FDA documentation. Specifically, FDA reissued certain decontamination unit EUAs to identify the types of respirators these units can decontaminate and to reduce the number of times a respirator could be decontaminated, among other things.

Umbrella EUAs. Since March 2020, FDA has issued nine umbrella EUAs for PPE and other medical devices. [218] FDA first used umbrella EUAs during the COVID-19 pandemic, allowing the agency to authorize certain types of devices rather than individual products, according to FDA officials. These nine umbrella EUAs covered at least 534 device models across at least 299 different manufacturers as of March 10, 2021, demonstrating how one umbrella EUA can expand access to many devices (see table). FDA has reissued four of these umbrella EUAs at least once and revoked two since March 2020.
Umbrella Emergency Use Authorizations (EUA), Reissuances, Revocations, and Number of Authorized Manufacturers and Device Models for COVID-19, as of March 10, 2021

Device category for EUA

Number of authorized manufacturers per each umbrella EUA

Number of authorized models per each umbrella EUA

Number of times EUA reissued

EUA revocations

Non-NIOSH approved KN95 respirators, manufactured in China

167

256

3

0

Non-NIOSH approved N95 respirators, manufactured outside of China

35

81

2

0

Surgical masks

17

34

0

0

Ventilators and ventilator accessories

84

163

0

0

NIOSH approved N95 respiratorsa

Not available

Not available

2

0

Surgical gowns and other apparela

Not available

Not available

0

0

Face shieldsa

Not available

Not available

1

0

Infusion pumpsb

0

0

0

1

Protective barrier enclosuresa

Not Available

Not Available

0

1

All devicesc

299

534

8

2
Source: GAO analysis of data from the Food and Drug Administration’s (FDA) website and information obtained from agency officials. | GAO-21-387

Note: We reviewed documentation made publicly available by FDA, including authorization, reissuance, and revocation letters and information on FDA’s website. Each row in the table represents a single umbrella EUA.
aFDA did not require manufacturers to submit separate requests for models under these umbrella EUAs. Therefore, we cannot determine the total number of authorized manufacturers and models.
bFDA authorized no manufacturers or infusion pump models prior to the EUA revocation.
cNumbers per EUA device category may not add up to the “all devices” total, as some manufacturers were authorized to produce devices for several EUAs and would not have been counted more than once.

According to FDA, the agency revoked two umbrella EUAs—one for infusion pumps and one for protective barrier enclosures—determining, among other things, that individualized consideration of each EUA request for these devices would better protect the public health. In the case of the umbrella EUA for infusion pumps, FDA authorized no manufacturers or infusion pump models prior to the EUA revocation. FDA officials said they have learned several lessons about the umbrella EUA process during the pandemic, which have included gaining a better understanding of what device types are suited for umbrella EUAs.

FDA reissued four umbrella EUAs at least once, three of which were umbrella EUAs for filtering facepiece respirators (respirators):
  • The umbrella EUA for NIOSH approved respirators was reissued to expand the scope of authorization beyond filtering facepiece respirators to include other types of respirators, as well as to include respirators that undergo decontamination with an FDA authorized decontamination system.
  • The umbrella EUA for non-NIOSH approved KN95 respirators manufactured in China was reissued three times between April and October 2020 due to safety concerns, among other reasons. According to FDA documents, FDA limited the scope of authorization for these devices at several points in time based on new data that these respirators were not meeting FDA standards. The final reissuance in October 2020 was due to decreased demand in KN95 respirators within health care settings, resulting in FDA’s decision not to review any additional EUA requests for this type of device.
  • The umbrella EUA for non-NIOSH approved N95 respirators manufactured outside of China was reissued twice to improve availability, as well as to address safety concerns. For example, one reissuance allowed for the reuse of these respirators once decontaminated with an authorized decontamination unit, according to FDA documents.

Benefits of EUAs for devices during COVID-19. FDA officials and most stakeholder associations we interviewed stated that the use of EUAs helped address critical medical device shortages. According to FDA officials, EUAs are one of the key pathways to allow providers to gain access to critical medical devices that have not received premarket approval or 510(k) clearance.

Officials from some health care provider associations told us that medical device EUAs—in particular, those related to respirators—enabled providers to provide better care for COVID-19 patients and to protect themselves from infection. Association comments included:
  • Respirator EUAs opened up a new supply that mitigated shortages seen at the beginning of the pandemic, officials from one provider association told us. According to these officials, hospitals would have been unable to respond to the pandemic without such EUAs.
  • Remote patient monitoring devices authorized under EUAs allowed clinics to monitor patients with chronic diseases who were unable to meet with providers in-person during the pandemic, according to officials at another association.

In addition, officials from a device manufacturer association said that device EUAs enabled the medical technology industry to mobilize quickly to support health care providers and their patients. For example, FDA authorized the use of a decontamination system that could result in 750,000 masks per day being decontaminated for re-use, if fully utilized, according to these officials.

Coordination across FDA, CDC, and OSHA during current and future pandemics. FDA, CDC, and OSHA each have a role in ensuring the proper use of respirators and systems used to decontaminate them. However, we identified some inconsistencies between device use permitted by FDA’s EUAs for respirators and systems for their decontamination, and CDC and OSHA guidance for such devices. For example
  • FDA issued an EUA on March 2, 2020, to authorize use of NIOSH approved respirators past the manufacturer’s recommended shelf life; however, OSHA did not issue guidance permitting this until roughly a month later. [219] Similarly, FDA reissued the EUA on March 28, 2020, to permit the decontamination and reuse of certain respirators; however, OHSA did not release guidance on this topic until April 24, 2020, nearly a month later.
  • In October 2020, CDC recommended that respirators be reused no more than five times. However, between March 2020 and January 2021, FDA guidance for certain EUAs for decontamination systems authorized respirator decontamination and reuse up to 10 or 20 times. In January 2021, FDA reissued many decontamination system EUAs to limit the number of cycles to no more than four, consistent with CDC’s recommendations.

FDA and CDC officials explained that guidance inconsistencies for decontamination arose in part due to differing perspectives on the number of times a respirator can safely be reused. For example, while both agencies relied on scientific evidence to support their decisions, FDA’s EUA decisions also took into account the agency’s goal to increase the available supply as much as possible to meet demand. Both agencies said that inconsistencies could be minimized by better information sharing.

According to some association officials we interviewed, the inconsistent guidance caused confusion and hesitancy among providers about how these devices could be used. For example, providers were reluctant to use devices with EUAs out of concern that doing so would conflict with another agency’s standards. This potentially undermined the use of these critical devices in the early stages of the pandemic.

FDA initiated webinars with CDC and OSHA in June 2020 to help address stakeholder questions; however, officials from all three agencies acknowledged the importance of coordination and information sharing to help address conflicts between EUAs and related guidance sooner. Although officials from all three agencies noted that they have good informal relationships, there is no documented process for sharing information. [220] Such a lack of sharing between agencies increases the risk of inconsistent decision-making and guidance related to devices with EUAs during this pandemic or future emergencies. Our key practices for enhancing and sustaining collaboration among federal agencies recommend that agencies should establish compatible policies, procedures, and other means to operate across agency boundaries.

Developing a process for FDA, CDC, and OSHA to share EUA device information to facilitate decision-making and guidance consistency, would help to mitigate confusion and hesitancy among providers about using devices with EUAs. In turn, this would facilitate the realization of a key goal of EUAs—to mitigate device shortages by expanding access to and use of such critical medical supplies.

Transition from use of authorized devices after the relevant EUA declarations have been terminated . Officials from manufacturer and distributor associations we spoke with said that, to ensure a smooth transition after the EUA declarations have been terminated, it will be important for FDA to specify a reasonable timeline and process for transitioning devices authorized for use during the emergency to clearance, approval, or appropriate disposition. [221] Association officials made the following points:
  • Manufacturers with authorized devices will require time to obtain FDA clearance or approval to continue offering their devices after the EUA declarations end, according to officials from two associations. Depending on the level of risk associated with the devices, manufacturers generally need to obtain 510(k) clearance or premarket approval to continue to market authorized products after EUAs are no longer in effect. However, lengthy delays in FDA’s review of 510(k) submissions and lack of responsiveness about the status of submissions have been reported by medical device manufacturer association officials. FDA officials stated that 510(k) review times were within their goals for devices used in response to the pandemic, but explained that they have received a record number of EUA requests for COVID-19 and non-COVID-19 related 510(k) submissions.
  • Medical device distributors and manufacturers require a transition period to adjust supply chain purchasing, such as overseas material purchasing, and distribution, according to officials from two associations we interviewed. Distributors would be unlikely to be able to return—or recoup losses associated with—previously authorized devices. Similarly, manufacturers are not sure if they would need to immediately stop making and remove devices with EUAs from the market, or if there were any circumstances in which FDA might permit use of authorized devices after the EUA declarations end, according to association officials representing these stakeholders. Manufacturer association officials said that a member manufacturer did not pursue an EUA for a new device it had developed due to uncertainty about how the device could be used after the EUA declaration ends.
  • Frontline health care staff lack confidence in using some medical devices with EUAs because such usage is not standard care, and are concerned that employers will continue to use crisis capacity standards after the EUA declarations end, according to some provider associations. FDA, OSHA, and CDC will play a role in ensuring that providers return to conventional standards of care, for example, using only NIOSH approved respirators.

In addition to these association concerns, the Department of Health and Human Services (HHS) purchased for the Strategic National Stockpile certain ventilator models and respirators with EUAs, according to the agency responsible for the federal stockpile. Further, some states have stockpiled devices with EUAs, according to association officials representing states. As stockpiles are designed to provide for the security of the nation during public health emergencies, it is important to know how, and for how long, certain authorized devices may continue to be used after the EUA declarations end.

The ECRI Institute—an organization that conducts independent medical device evaluations—has similarly cautioned providers about the status of authorized products after the EUA declarations end. [222] For example, in an April 2020 alert, the ECRI Institute cautioned that hospitals should seek clarity on the post-EUA declaration status of ventilators before purchasing them, and in a May 2020 alert, it recommended that healthcare facilities consider the financial implications of purchasing devices with EUAs given that an EUA generally remains in effect only during the EUA declaration. [223]

The Secretary of Health and Human Services is required to provide notice prior to the termination of the EUA declarations and consult with manufacturers about proper disposition of authorized devices. [224] In addition, FDA has indicated that it intends to develop draft guidance for a transition plan for medical devices distributed under EUAs for COVID-19 by the end of the fiscal year 2021. FDA officials told us the agency would publish the transition plan as draft guidance to receive feedback from stakeholders and provide sufficient time before the EUA declarations end for stakeholders to provide comments. FDA officials also noted that they intend for the transition plan to describe a timeframe for manufacturers to obtain clearance or approval of their devices before the EUA declarations terminate. Further, FDA officials stated the transition plan will include a policy addressing authorized devices that have a pending premarket review submission but have not yet been approved or cleared by the time the EUA declarations terminate.

However, in light of the ongoing pandemic, as of March 15, 2021, the agency had not released a draft transition plan. As a result, important aspects of the transition plan for devices with EUAs are unknown and remain to be determined, including the timeline and process for transitioning authorized devices to full clearance, approval, or appropriate disposition and the extent to which stakeholder feedback, including from CDC and OSHA, will be incorporated.

Specifying a reasonable timeline and process for transitioning authorized devices to clearance, approval, or appropriate disposition that incorporates stakeholder input, before the EUA declarations end, would be consistent with the PanCAP Adapted. The PanCAP Adapted is the general operative plan for the federal response to COVID-19; it highlights the importance of clear communication during a crisis. [225] Further, it would be consistent with federal standards for control activities, which emphasize that agencies should design and implement policies and procedures to achieve their objectives—in this case, ensuring a smooth transition from use of authorized devices. [226]

Further, taking such action would help to provide a smooth transition for manufacturers, purchasers, and users of devices with EUAs. This is the agency’s opportunity to mitigate concerns about approval or clearance time, use of stockpiled devices with EUAs, and efforts by other federal agencies to return to conventional standards of care, prior to the end of the EUA declarations.

Agency Comments

We provided HHS, DOL, and the Office of Management and Budget (OMB) with a draft of this enclosure. HHS provided general comments, which are reproduced in Appendix VI: Comments from the Department of Health and Human Services . HHS concurred with both of our recommendations. Regarding our recommendation for FDA and CDC to work with OSHA to develop a process for sharing information related to devices with EUAs, FDA commented that there is an opportunity to build on prior collaboration and lessons learned during the pandemic to assure there is a process in place that yields timely and consistent information for stakeholders using and purchasing authorized devices. Regarding our recommendation for FDA to specify a reasonable timeline and process for transitioning authorized devices that takes into account stakeholder feedback, FDA stated that it believes it is important to provide such a transition period to allow sponsors to meet any additional requirements. In addition, FDA stated it will provide the transition plan in the form of draft guidance for public comment so the agency can work to incorporate suggestions from those impacted by the transition.

DOL also concurred with the recommendation for OSHA to work with FDA and CDC to develop a process for information sharing related to devices with EUAs. HHS and DOL provided technical comments on this enclosure, which we incorporated as appropriate. OMB did not provide comments on this enclosure.

Methodology

To conduct this work, we reviewed relevant agency documents, including FDA’s guidance for EUAs and transcripts from webinars for medical device EUAs that FDA began hosting in June 2020. For each device EUA, we reviewed publicly available documentation on FDA’s website as of March 10, 2021, including authorization letters for each EUA. [227] We also reviewed relevant CDC and OSHA documents related to safe use of devices during the COVID-19 pandemic. We received written responses to questions from FDA, CDC, and OSHA officials.

We also interviewed or received written responses from 15 stakeholder associations—2 associations representing device manufacturers, 1 association representing device distributors, and 12 associations representing a variety of medical device purchasers, including 3 associations representing state or local public health or emergency management departments, 8 associations representing a variety of provider types, and 1 public health association. We selected these national associations based on their involvement in representing stakeholders that manufacture or purchase devices for use on the front lines of responding to the COVID-19 pandemic.

Contact information: Mary Denigan Macauley, (202) 512-7114, deniganmacauley@gao.gov

Related GAO Products

COVID-19: Federal Efforts Accelerate Vaccine and Therapeutic Development, but More Transparency Needed on Emergency Use Authorizations. GAO-21-207 . Washington, D.C.: November 17, 2020.

Managing for Results: Key Considerations for Implementing Interagency Collaborative Mechanisms. GAO-12-1022 . Washington, D.C.: September 27, 2012.

Results-Oriented Government: Practices That Can Help Enhance and Sustain Collaboration among Federal Agencies. GAO-06-15 . Washington, D.C.: October 21, 2005.

COVID-19 Cyber Response

The Department of Health and Human Services has continued collaboration and coordination efforts to mitigate cyber threats against assets and organizations targeted during the federal response to COVID-19. In addition, the department continues to make progress implementing our prior recommendations regarding cybersecurity weaknesses at its component agencies. We encourage the Department of Health and Human Services’ component agencies to implement the remaining open recommendations to bolster its cybersecurity posture.

Entities involved: Department of Health and Human Services; Cybersecurity and Infrastructure Security Agency, within the Department of Homeland Security; and Federal Bureau of Investigation, within the Department of Justice

Key Considerations and Future GAO Work

In our September 2020 report, we recommended that the Department of Health and Human Services (HHS) expedite implementation of our prior 434 recommendations regarding cybersecurity weaknesses at its component agencies. As of February 2021, HHS officials reported actions the department is taking to implement the recommendation, to include leveraging its monthly Chief Information Security Officer Council meetings to discuss recommendations made across the HHS component agencies.

Additionally, HHS’s relevant component agencies—the Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services, and Centers for Disease Control and Prevention—have addressed additional cybersecurity weaknesses since we reported in November 2020. [228] Specifically, the three component agencies implemented an additional 17 of our previous cybersecurity recommendations, bringing the total number of implemented recommendations to 421 of the 434 we made to these agencies. [229] This amount reflects a 4 percent increase in corrective actions these component agencies have taken to bolster their cybersecurity. [230]

In addition to monitoring the department’s efforts to expedite implementation of our prior cybersecurity-related recommendations at its component agencies, we are conducting an ongoing review of HHS’s roles and responsibilities for assisting with cybersecurity in the health care and public health critical infrastructure sector. [231] This review includes an evaluation of the department’s efforts to collaborate and coordinate as part of its response to COVID-19-related cyberattacks.

Background

The federal response to COVID-19 has highlighted the need for additional focus on the security of information systems that are used by health care organizations involved in vaccine and therapeutic development and distribution, and that provide telehealth medical services. The prior administration initiated Operation Warp Speed in May 2020 to accelerate the development, manufacturing, and distribution of COVID-19 vaccines and therapeutics. In addition, health care organizations began offering health care services through telehealth appointments to slow the spread of the virus. All of these efforts rely heavily on the support of information systems.

During the nation’s response to COVID-19, systems operated by the health care and public health sector have been the target of malicious cyber activity. The actors behind this activity were attempting to obtain, among other things, patient information, intellectual property, public health data, and intelligence. Therefore, it is imperative that safeguards are implemented on the systems supporting the health care and public health sector. As the designated sector-specific agency for the health care and public health critical infrastructure sector, HHS is responsible for collaborating with sector partners and coordinating activities to mitigate the harm caused by cyber threats to the sector’s systems. [232]

Overview of Key Issues

In our November 2020 report, we described HHS’s collaboration with health care organizations and coordination with other federal agencies to address cybersecurity concerns associated with COVID-19 in the health care and public health sector between March 2020 and August 2020. Since that time, HHS has continued to collaborate with its sector partners through the various cybersecurity-focused working groups it leads. During the cybersecurity-focused working groups’ meetings, HHS and its partners shared information about efforts managed by Operation Warp Speed and ongoing efforts to secure telehealth medical services, as described here.
  • During an August 2020 meeting for the Joint Healthcare and Public Health Sector Cyber Working Group, the government and industry participants discussed chief information security officers’ concerns with Operation Warp Speed due to perceived cyber threats to potential COVID-19 therapeutic and vaccine supply chains. [233]
  • During a September 2020 biweekly meeting, the Government Coordinating Council’s (GCC) Cybersecurity Working Group Telehealth Task Group shared information on challenges to protecting the security and privacy of health information and personal data as telehealth medical services were expanded and information was transferred across networks. [234] The task group highlighted the importance of considering vulnerabilities in the system architecture supporting telehealth medical services as a way to mitigate security and privacy challenges.
  • During the October 2020 meeting for the GCC Cybersecurity Working Group, HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR) informed the meeting participants that its Telehealth Task Group would serve as the entity through which federal entities involved in providing telehealth medical services will collaborate to identify, prioritize, and develop resources for federal agencies and their stakeholders to mitigate the major cybersecurity, compliance, and privacy risks.
  • During a December 2020 meeting with the Joint Healthcare and Public Health Sector Cyber Working Group, the participants (1) discussed cybersecurity concerns related to Operation Warp Speed’s vaccine distribution process; and based on these concerns, (2) planned to document the cybersecurity risks and develop considerations for custodial checklists on cold storage that may help mitigate those risks.

Moreover, officials in HHS’s Office of the Chief Information Officer informed us that the department’s Chief Information Security Officer (CISO) attends weekly meetings with a limited group of key stakeholders to collaborate around the implementation of Operation Warp Speed. According to the officials, these meetings are held in addition to HHS CISO Council meetings and are classified. [235]

HHS has also continued to coordinate with the Cybersecurity and Infrastructure Security Agency (CISA) and Federal Bureau of Investigation (FBI). Specifically, HHS’s ASPR has continued to host weekly meetings with the HHS Health Sector Cybersecurity Coordination Center, CISA, and FBI as part of the Cyber Watch Project. [236] Since August 2020, these federal agencies have coordinated on:
  • identifying additional entities involved in the development of vaccines and therapeutics that the federal agencies plan to engage with as part of the project;
  • resolving redundancies in the list of entities covered by Operation Warp Speed and the Cyber Watch Project;
  • determining how best to accurately advertise cybersecurity webinars and briefings so that they reach the intended audiences;
  • informing critical entities about recent ransomware attacks that occurred within the health care and public health critical infrastructure sector; and
  • ensuring that all federal agencies leading cyber engagement activities with the entities involved in vaccine and therapeutic development have the latest information on all those activities.

Agency Comments

We provided HHS and the Office of Management and Budget a draft of this enclosure for review and comment. HHS and the Office of Management and Budget did not provide any comments on this enclosure.

Methodology

To conduct this work, we obtained documentation demonstrating recent efforts of HHS’s cybersecurity-focused working groups to collaborate and coordinate with other entities on cybersecurity issues related to COVID-19. Specific documentation we reviewed included meeting presentations, summaries, and notes describing the information shared and discussed during those working group meetings. In addition, we interviewed officials in HHS’s Office of the Chief Information Officer and ASPR to obtain information and documentation on any new collaboration or coordination efforts to respond to the increased cyberattacks associated with COVID-19. Further, to update the status of the recommendations made to the HHS component agencies, we obtained and assessed evidence to determine whether the agency took appropriate corrective action to resolve the cybersecurity weaknesses identified in our prior reports.

Contact information: Jennifer R. Franks, (404) 679-1831, franksj@gao.gov

Telecommunications Funding for Telehealth

Between April and July 2020, the Federal Communications Commission obligated the full $200 million appropriated by the CARES Act to prevent, prepare for, and respond to COVID-19, domestically or internationally, including for telehealth support through 539 awards to 532 health care providers to fund, among other things, telehealth visits and remote patient monitoring during the pandemic. According to Federal Communications Commission officials, as of February 18, 2021, $143.2 million of the $200 million had been disbursed.

Entity involved: Federal Communications Commission

Key Considerations and Future GAO Work

As of February 18, 2021, of the $200 million appropriated by the CARES Act, Federal Communications Commission (FCC) officials told us that $143.2 million had been disbursed to eligible health care providers (providers). FCC officials told us FCC expects the remaining $56.8 million to be disbursed shortly after FCC’s July 31, 2021, invoicing deadline. Additionally, in legislation enacted in December 2020, Congress appropriated approximately $250 million to FCC for the COVID-19 Telehealth Program, which FCC has used to provide additional funding to providers for telecommunications, information services, and connected devices. [237] As of February 2021, FCC officials told us that FCC was continuing to review comments received in the public record related to awarding this additional funding. We will continue to monitor FCC’s efforts to distribute funding appropriated through the COVID relief laws.

Background

Telehealth, or the provision of health care services through a range of telecommunications technologies, has increasingly assumed a critical role in health care delivery throughout the U.S. The ability to diagnose, monitor, and treat patients remotely allows providers to offer critical services to patients in their homes or in other physically distanced locations, which can reduce the spread of communicable diseases such as COVID-19.

Demand for telehealth services dramatically increased because the COVID-19 pandemic limited providers’ ability to treat patients in person. [238] However, providers faced challenges offering telehealth services, including high implementation costs and limited patient access to broadband internet. Such barriers particularly affect the public and nonprofit providers that serve low-income patients.

In March 2020, FCC established the $200 million COVID-19 Telehealth Program in response to the CARES Act to support eligible public and nonprofit providers’ provision of telehealth services by funding eligible telecommunications services, information services, and connected devices on a temporary basis. [239] Examples of eligible services and devices include costs for mobile hot spots, subscription costs for telehealth applications or platforms, and purchase costs for connected monitoring devices such as wifi, Bluetooth, or internet-connected blood pressure monitors. [240]

FCC obligated the $200 million to health care providers on a rolling basis between April 2020 and July 2020. As of February 18, 2021, approximately $143.2 million had been disbursed to awardees. In December 2020, FCC established a July 31, 2021 invoicing deadline for awardees to submit their requests for reimbursement to FCC.

Overview of Key Issues

FCC application and reimbursement processes. FCC required providers seeking CARES Act funding to submit applications that included information such as the medical services to be provided, conditions and types of patients to be treated, and supporting cost documentation. Providers were also required to complete additional steps, including obtaining an eligibility determination and registering with FCC and the System for Award Management. [241] FCC used a review process in which multiple teams at escalating levels of seniority iteratively reviewed applications. FCC officials considered a number of factors when reviewing and approving applications which, according to FCC officials, were consistent with the guidance in the Report and Order establishing the program. For example, FCC gave priority to providers that were located in areas hardest hit by COVID-19, including those that would have the greatest impact based on the amount of funding requested, the number of patients to be served, or whether a provider would serve tribal communities. [242]

Once FCC obligated funding to awardees, they purchased eligible goods and services and submitted requests to FCC for reimbursement, including invoice documentation, using the U.S. Department of the Treasury’s Invoice Processing Platform. FCC officials told us that, as with applications, these requests undergo a multilevel review process to verify that the goods and services purchased are eligible and that the invoice documentation supports the amount being requested for reimbursement.

FCC oversight and performance management. According to FCC officials, the multilevel application and reimbursement process provides FCC with oversight of the program and mitigates identified risks to program integrity. For example, awardees must submit detailed invoices substantiating reimbursement requests, which FCC reviews to ensure compliance with program rules. FCC officials explained that this process guards against the risk of, and helps FCC identify, improper payments. FCC officials told us that as of February 2021, they had identified seven improper payments totaling just under $160,000 through their invoice review processes or notification by awardees, and had recovered about $112,000. [243]

In addition, FCC is leveraging audits conducted under the Single Audit Act to oversee the program. [244] One FCC official told us that FCC estimates that about 66 percent of the funding disbursed through the program is subject to Single Audit Act requirements. As of February 2021, this official said that auditors had completed 22 audits under the Single Audit Act that contained the FCC compliance supplement for the COVID-19 Telehealth Program, and these audits did not contain any findings. FCC officials said that while FCC had not yet conducted any additional compliance audits, FCC continues to monitor the coverage of the Single Audit Act and other factors to determine the need for such audits. Further, FCC stated that all awardees should submit post-program feedback by January 2022 that includes, among other information, a description of the funding outcomes.

Program challenges. FCC officials, selected providers, and telehealth associations we spoke to identified some challenges with the application and reimbursement processes, such as the following:
  • Information technology system difficulties. FCC, both selected providers, and both telehealth associations we spoke to reported complicated application and reimbursement systems or systems that were not user-friendly or did not always work as planned. To address this challenge, FCC intends to update its application system before accepting applications for the additional funding appropriated in December 2020. [245]
  • Site-specific eligibility determinations. Both selected providers we spoke to told us that because eligibility is determined on a site-by-site rather than provider basis, it was more difficult for providers with multiple sites to apply for awards and seek reimbursement. FCC also noted that this site-specific requirement delayed its ability to move quickly on many applications. To address this challenge, in January 2021 FCC sought comment on using a different approach to determine whether a site is eligible for future funding. [246]
  • Lack of in-person assistance or unclear guidance from FCC. One selected provider and both telehealth associations told us that FCC guidance was confusing. For example, one provider said that email assistance from FCC did not help to clarify guidance on eligible goods and services, so the provider did not understand what was and was not eligible until the invoicing process, after completing purchases. As a result, the provider did not expect to receive reimbursement for its full award amount. In January 2021, FCC proposed providing additional outreach and guidance to applicants by, for example, publishing a list of eligible and ineligible equipment and services for future funding. [247]

Additionally, both selected providers and telehealth associations told us that FCC did not cover providers’ costs for support services and non-connected devices required to make eligible goods and services work properly, such as training costs or costs for things like power cords. As a result, according to one association, some providers were deterred from applying to the program, and some that received funding struggled to cover these costs.

Distribution of funding. FCC made 539 awards to 532 health care providers in 49 U.S. states, territories, and the District of Columbia. [248] According to our analysis of FCC data, the number of awardees and amount of funding varied across states (see figure). FCC awarded more than half of the $200 million to health care providers in 10 states: New York, Ohio, California, Pennsylvania, New Jersey, Texas, Florida, Massachusetts, Washington, and Louisiana. The awards generally aligned with FCC’s prioritization of the hardest-hit geographic areas. [249]

Total COVID-19 Telehealth Funding Awarded by the Federal Communications Commission and Number of Awardees, by State

Note: Funds for the awards came from CARES Act, Pub. L. No 116-136, 134 Stat. 281, 531 (2020).

According to our analysis of FCC public notices, most awards included funding to support telemedicine visits and to purchase connected devices, and were targeted toward continued patient care (see table). [250]
Purposes for the 539 COVID-19 Telehealth Awards Issued by the Federal Communications Commission

Award purpose

Number and percentage of awards that included funding for this purpose

Examples of award purposes

Type of health care service supported

Telemedicine visits and care

480 (89%)

Includes funding to support phone or video visits, consultations, or other remote care conducted over the phone or internet.

Remote monitoring

177 (33%)

Includes funding for a program in which a medical professional uses connected devices or telecommunications services to monitor vital signs, conditions, or other patient health statistics remotely.

Type of telecommunications service supported

Connected devices

471 (87%)

Includes devices such as laptops, tablets, telehealth carts, video equipment, or remote monitoring devices that are connected to and transmit health information using telecommunications services or that facilitate telehealth visits.

Telehealth software

297 (55%)

Includes applications, software licenses, subscriptions, or platforms that facilitate telehealth visits or remote monitoring.

Internet or telecommunications service

195 (36%)

Includes phone or internet services or plans, including mobile hotspots, as well as network upgrades that typically increase the overall speed, capacity, or capability of phone or internet services.

Target population

High-risk or vulnerable patients

251 (47%)

Includes funding specifically for patients that are at higher risk for adverse health outcomes, such as elderly or pediatric patients, patients with chronic conditions, and low-income, underserved, un- or under-insured, rural, and tribal populations.

Patients with suspected or confirmed COVID-19

173 (32%)

Includes funding for diagnosis or treatment of patients with suspected or confirmed COVID-19.

Continued care of patients without COVID-19

488 (91%)

Includes funding to support continued care of patients generally, such as primary or routine care, preventative care, or specialty care, or to treat patients with chronic conditions.
Source: GAO analysis of Federal Communications Commission public notices on COVID-19 telehealth awards from April to July 2020. | GAO-21-387

Note: Funds for the awards came from the CARES Act, Pub. L. No 116-136, 134 Stat. 281, 531 (2020). A single award can include all or some of the purposes listed here. As a result, the number of awards listed for each purpose does not add up to the total awards issued. Health care providers may seek reimbursement for different items or service than those upon which FCC based its awards, as long as they comply with program rules.

Agency Comments

We provided a draft of this enclosure to FCC and the Office of Management and Budget for comment. In its comments, reproduced in appendix V , FCC agreed with our findings. FCC also provided technical comments which we incorporated as appropriate. The Office of Management and Budget did not provide comments on this enclosure.

Methodology

We analyzed FCC data on COVID-19 telehealth funding obligated between April and July 2020, including FCC’s public notices issued during that time. We conducted manual reviews, cross-checked these data with corroborating sources, and interviewed FCC officials and found these data to be reliable for the purposes of describing the obligation and purpose of the funding. We also interviewed FCC officials responsible for overseeing the program. To obtain nongeneralizable perspectives on the application and reimbursement processes, we interviewed two health care providers that received funding, which we selected for a variety of funding amounts and locations, and two telehealth associations that represent health care providers.

Contact information: Andrew Von Ah, (202) 512-2834, vonaha@gao.gov

Hospital and Pharmacy Perspectives on COVID-19 Vaccine Administration and Medical Supply Availability

Our February 2021 hospital survey and interviews with large retail pharmacy chains and an association of independent pharmacies revealed concerns about COVID-19 vaccine availability and limitations in certain key medical supplies for administering the vaccines—notably, syringes and needles. Personal protective equipment and COVID-19 testing supplies also remain a challenge for some.

Entities Involved: The Department of Health and Human Services and the Federal Emergency Management Agency.

Key Considerations and Future GAO Work

Our CARES Act work has highlighted persistent constraints with the availability of certain types of personal protective equipment (PPE) and testing supplies due to a supply chain with limited domestic production and high global demand. Specifically:
  • In September 2020, we found that the Food and Drug Administration (FDA) and the Federal Emergency Management Agency (FEMA) had both identified shortages of certain supplies. We also reported that an American Nurses Association survey indicated widespread reuse of single-use N95 respirators, and that the majority of nurses who were required or encouraged to do so were concerned about their safety as a result.
  • In November 2020, we published the results of a nationwide survey of state and territorial public health and emergency management officials, which indicated continued limitations in the availability of certain medical supplies, such as nitrile gloves and reagents used for COVID-19 testing.
  • In January 2021, we reported that FEMA issued an extension through June 30, 2021, of its temporary final rule that generally prohibits the export of critical PPE, including N95 respirators, surgical masks, nitrile gloves, and surgical gowns. In issuing the rule on December 31, 2020, the agency noted that “domestic supply of the allocated PPE has not kept pace with demand and is not anticipated to do so.” [251] Similarly, as vaccination efforts ramp up, FEMA has identified projected shortages in certain medical supplies necessary for vaccination, such as specific types of syringes and needles. The temporary final rule added these items to the list of supplies that may not be exported.

To address issues of supply shortages, we recommended in September 2020 that the Department of Health and Human Services (HHS)—the lead agency in charge of the federal public health response to the pandemic—in coordination with FEMA
  • further develop and communicate to stakeholders plans outlining specific actions the federal government will take to help mitigate supply chain shortages for the remainder of the pandemic.
  • immediately document roles and responsibilities for supply chain management functions transitioning to HHS, including continued support from other federal partners, to ensure sufficient resources exist to sustain and make the necessary progress in stabilizing the supply chain.

HHS disagreed with these recommendations, noting, among other things, the work that the department had done to manage the medical supply chain and increase supply availability.

We recognize the efforts of federal agencies in improving the supply chain. However, our February 2021 survey of officials from selected hospitals and our interviews with representatives from retail pharmacy chains and an association of independent pharmacies, described below, underscore the critical imperative that HHS and FEMA implement our recommendations. For example, communicating with stakeholders, as we recommended, would help the agencies to determine further steps needed to address concerns for the remainder of the pandemic. In our February review, we found that some hospital officials and retail pharmacy chain representatives raised concerns that the amount of vaccine doses they could administer were limited by the types of syringes they were receiving. Taking the actions we previously recommended would help address current medical supply chain challenges, as well as help to mitigate any future challenges.

The Consolidated Appropriations Act, 2021—passed in December of 2020—requires the President to make publicly available a report containing a whole-of-government plan for effective response to subsequent COVID-19 outbreaks and for future global pandemic diseases. The act stipulates that this pandemic plan should address how to improve the role of the federal government with respect to the regulation, acquisition, and disbursement of medical supplies necessary to respond to COVID-19, including the procurement and distribution of PPE, among other things. Developing and making publicly available a pandemic plan that addresses medical supply needs for the remainder of the current pandemic would be consistent with our September recommendation.

We recognize that the new administration has taken initial actions beginning in January 2021 to create a more resilient supply chain and increase vaccine availability. For example, the administration has directed certain federal agencies to develop a strategy by July 2021 to design, build, and sustain medical supply manufacturing capabilities in the U.S. long-term. [252] Further, the President has announced increased vaccine production, stating that the administration anticipates enough vaccine supply for every adult in the U.S. by the end of May 2021. We will continue to monitor these efforts, as well as progress on our recommendations regarding the medical supply chain. [253]

Background

Administering vaccines. Administering vaccines requires the ability of providers, such as hospitals and pharmacies, to manage orders as well as additional storage, staff, and IT system capacity.
  • Order management. Providers must be able to monitor the expected arrival of vaccine and ancillary supply kits.
  • Storage. Providers administering the vaccine need space for vaccines that may require varying levels of cold storage.
  • Staff. Providing COVID-19 vaccines requires a sufficient number of trained staff to handle the vaccines, manage vaccine inventory, and administer vaccines.
  • IT systems. Providers need to use information technology (IT) systems capable of managing the various processes involved in tracking COVID-19 vaccines.

Vaccine supplies. The quantity of supplies needed to administer COVID-19 vaccines to the U.S. population is so large that the federal government has contracted for the production and assembly of vaccine-related supplies into ancillary kits that it is distributing to facilities administering the vaccine. The ancillary supply kits contain surgical masks, face shields, syringes, needles, alcohol prep pads, vaccination cards, and—if applicable—diluent, a liquid for reconstituting a vaccine. [254] The kits do not include other supplies such as sharps disposal containers or bandages. (See figure below.) Our previous survey of state and territorial public health and emergency management officials in October 2020 generally indicated there were concerns about whether providers would have sufficient supplies to administer vaccines when available.

Examples of COVID-19 Vaccine Administration Supplies

Notes: The exact content of the kits may vary depending on the specific vaccine. A vaccination card shows an individual has received a vaccine (and how many doses) and documents relevant information such as vaccine manufacturer, lot number, and date of administration for each dose. Diluent is used to reconstitute Pfizer-BioNTech’s COVID-19 vaccine.

PPE and testing supplies. The demands of the global COVID-19 pandemic overwhelmed the medical supply chain, causing constraints in the availability of PPE supplies, including N95 respirators, surgical gowns, and gloves, as well as supplies needed to test patients for COVID-19 (see figures below). Testing supplies include nasal swabs used to collect viral specimens from patients, transport media that keep samples viable for testing, reagents and laboratory consumables—such as pipette tips—used to process tests, and rapid point-of-care tests.

Examples of Personal Protective Equipment

Examples of COVID-19 Testing Supplies

Overview of Key Issues

Our February 2021 survey of hospitals and interviews with large retail pharmacy chains and an association of independent pharmacies indicate these providers are concerned about COVID-19 vaccine availability and limitations in certain key medical supplies for administering the vaccines—notably, syringes and needles. [255] PPE and COVID-19 testing supplies also remain a challenge for some.

Providers expressed concerns about COVID-19 vaccine availability. Of the 166 total hospitals responding to our survey, 102 (61 percent) reported not having sufficient information to respond to questions from their staff, the public and others about vaccine availability. [256] Among the subset of rural hospitals responding to our survey (68 of 166 hospitals), 42 were concerned about responding to questions about vaccine availability. [257]

In addition, 35 of the 166 hospitals (21 percent) described concerns with general vaccine availability in open-ended survey responses. [258] For example, three hospitals reported concerns about having enough vaccine to administer a second dose to vaccine recipients. Another hospital’s staff responded that they had to cancel more than 1,000 planned vaccine doses to their most vulnerable populations due to lack of vaccines.

Similarly, our interviews with representatives from retail pharmacy chains and an association of independent pharmacies also revealed concerns about vaccine availability. Representatives from all nine retail pharmacy chains we interviewed stated that although their pharmacies have begun administering vaccines, their potential to administer vaccines is far greater than the current amount of vaccines available.

For example, representatives from one retail pharmacy chain that is participating in the Federal Retail Pharmacy Partnership Program—a federal program for administering vaccines—stated that the chain has the capacity to administer 25 million doses per month at their 9,900 locations. [259] However, the chain’s initial allocation of vaccines via the program was expected to be only 230,000 doses at 250 locations.

Representatives from an association of independent pharmacies expressed similar concerns about the quantity of vaccines available.

In addition to underutilization, several retail pharmacy chain representatives indicated that limited vaccine availability has led to uncertainty regarding the amount of vaccines their pharmacies can expect to receive each week. Without sufficient information on vaccine allocation, it is difficult to determine how many vaccine appointments they can schedule or the number of staff needed to fulfill those appointments. For example, representatives from one retail pharmacy chain said that due to uncertainty over the amount of vaccines they may receive in a given week, they can only schedule appointments on a week-to-week basis, which makes it difficult to address customers’ questions about when they will be able to schedule their vaccinations.

The new administration has taken steps to increase certainty and vaccine availability. For example, the White House announced at the end of January 2021 that the federal government would begin notifying states earlier about availability and shipments of vaccines, to give greater certainty for planning vaccination efforts. [260] Further, the President stated on March 2, 2021, that the administration expects to have produced enough vaccine for every adult in the U.S. by the end of May 2021.

Providers expressed concerns about availability of syringes and needles. In our survey, hospitals expressed concerns about the syringes and needles provided in the ancillary supply kits. Out of the 146 hospitals that reported they have either begun administering COVID-19 vaccines or plan to do so, 40 hospitals (27 percent) reported being greatly concerned about having a sufficient quantity of syringes in the next 30 days, and 43 hospitals (29 percent) were greatly concerned about having a sufficient quantity of needles. [261]

Among the 146 hospitals that had either begun administering COVID-19 vaccines or planned to do so, a subset of 56 were rural hospitals. Of these 56 rural hospitals, 10 hospitals were greatly concerned about quantities of syringes in the next 30 days, and 14 hospitals were greatly concerned about needles.

According to FDA, certain types of syringes and needles may allow health care providers to extract more doses of the COVID-19 vaccines than others. [262] Maximizing the number of doses is crucial during a time of constrained vaccine supply. Four hospitals specifically noted this issue in open-ended responses. [263]

Representatives from retail pharmacy chains also discussed this issue. Specifically, representatives from five of the nine retail pharmacy chains expressed concerns that the provided ancillary supply kits do not always contain the most efficient syringes needed to obtain the maximum doses of vaccines from each vial. Representatives from one retail pharmacy chain that had administered more than 200,000 doses at the time of our interview indicated that optimal syringes were only included in the ancillary supply kits about 50 percent of the time. Representatives from two retail pharmacy chains also noted that these syringes are in short supply on the open market.

The lack of more efficient syringes limits the ability to maximize the number of doses per vial, which further constrains the supply of vaccine. In January 2021, HHS and Department of Defense officials managing vaccine implementation told us they have recognized this issue and are working toward ensuring the majority of syringes included in the ancillary supply kits are the more efficient type of syringes. We will continue to monitor HHS’s vaccination efforts moving forward, including whether they have addressed this issue.

Providers cited several areas of concern about their capacity to administer the COVID-19 vaccine. In addition to supplies, administering vaccines requires managing vaccine orders as well as having additional storage, staff, and IT system capacity. See table below for the most commonly cited concerns among the 146 hospitals that plan to or have begun administering vaccines at the time of our survey. The subset of 56 rural hospitals generally cited the same concerns. [264]
Surveyed Hospitals’ Most Commonly Cited Concerns about Capacity to Administer Vaccines in February 2021

Number of hospitals

Hospitals that plan to or have begun administering COVID-19 vaccines

146

Ordering aconcerns

Being able to track the expected arrival of vaccine orders

40

Being able to track the expected arrival of kits with ancillary vaccination supplies to the hospital

22

Storage b concerns

Storing vaccine in ultra-cold storagec

32

Staff dconcerns

Having sufficient number of trained providers to administer vaccine

33

IT systems econcerns

Interfacing with state or other external IT systems to document vaccine administration

31

Meeting federal reporting requirements for vaccine administration (e.g., reporting all required elements, reporting within required time frames)

24
Source: GAO analysis of hospital survey responses. | GAO-21-387

Notes: The results in this table are based on our non-generalizable survey sent to 383 short-term and critical access hospitals across the country. We fielded the survey from February 5, 2021 through February 25, 2021, and received responses from 166 hospitals. Twenty-one of the survey responses we received were on behalf of a larger health system or multiple facility group representing multiple hospitals. For the purposes of this enclosure, we reported each health system’s response as a single hospital response rather than as the number of hospitals represented by the system. For this survey question, we asked the 146 hospitals that reported they plan to, or have begun, administering COVID-19 vaccines to report whether they were greatly concerned about their capacity to handle specific aspects of the vaccine, as of the date they were answering the survey. Survey respondents also had an open-response option to report any other concerns not listed in the survey response options. The concerns in the table above were cited by at least 15 percent of the 146 hospitals.
aOrdering vaccine concerns response options were: using required IT systems to order vaccine; being able to monitor the expected arrival of vaccine orders to the hospital; being able to monitor the expected arrival of kits with ancillary vaccination supplies to the hospital; other (fill-in); and no great concerns about ordering vaccines. 146 hospitals responded to the questions in the ordering category.
bStoring vaccine concerns response options were: storing refrigerated (2°C to 8°C) vaccine; storing frozen(-15° C to -25°C) vaccine; storing ultra-cold (-60°C to -80°C) vaccine; other (fill-in); and no great concerns about vaccine storage. 145 hospitals responded to questions in the storing category.
cPfizer-BioNTech’s COVID-19 vaccine requires ultra-cold storage between -80°C and -60°C (-112°F and -76°F) when storing for longer periods of time.
dStaff to manage and administer vaccine concerns response options were: having sufficient number of trained staff to handle and manage vaccine inventory; having sufficient number of trained providers to administer vaccine; other (fill-in); and no great concerns about staff. 144 hospitals responded to questions in the staff category.
eHaving/using IT systems to track/report administered doses concerns response options were: having IT systems to track the first dose of vaccine administered to patients; having IT systems to remind patients of need for a second dose, if needed; interfacing with state or other external IT systems to document vaccine administration; meeting federal reporting requirements for vaccine administration (e.g. reporting all data elements required, reporting administrations within required time frames); other (fill-in); and no great concerns about IT systems. 144 hospitals responded to questions in the IT systems category.

Representatives from all nine retail pharmacy chains and an association of independent pharmacies named data reporting requirements as a concern. Commonly cited concerns included
  • different local, state, and federal requirements. Representatives from eight retail pharmacy chains and an association of independent pharmacies noted challenges in meeting data requirements that differ across local, state, and federal governments. For instance, according to representatives from one retail pharmacy chain, one locality requires documenting recipients’ professions, while others do not. These unique elements are not always included in existing data systems, making it difficult to determine how to report them.
  • interoperability limitations. Representatives from seven retail pharmacy chains and a representative from an independent pharmacy also stated that interoperability limitations of some state data reporting systems have resulted in challenges, such as pharmacy staff having to manually transfer required information. As one retail pharmacy chain’s representative noted, this process is complicated, especially for chains that must coordinate across hundreds of locations.
  • time frames for reporting. The deadlines for submitting reports present some challenges. The federal government requires pharmacies to report data within 72 hours. However, representatives from five retail pharmacy chains and one independent pharmacy said that some states require reports within 24 hours. A representative from an independent pharmacy said such daily reporting has been a learning curve.

Representatives from three retail pharmacy chains and two independent pharmacies reported taking various actions to address identified challenges, including investing in new software, hiring additional administrative support, or modifying staff responsibilities, such as diverting pharmacists from administering vaccines. Representatives from two independent pharmacies mentioned the increased expenses pharmacies have incurred to address COVID-19 but noted that they have not received federal funding to pay for the additional staff and supplies they need.

We have previously reported on data challenges related to COVID-19. For example, in September 2020 we described state and local public health officials’ concerns regarding the cost and effort associated with providing data to federal entities to be integrated and shared on a nationwide basis. Also, in January 2021, we reported that the federal government does not have a process to help systematically define and ensure the collection of standardized data across the relevant federal agencies and related stakeholders to help respond to COVID-19. We recommended that HHS immediately establish an expert committee or use an existing one to systematically review and inform the alignment of ongoing data collection and reporting standards for key health indicators. In its comments, HHS partially concurred that it should establish such a body, but said because of resource constraints and the ongoing response to the pandemic, it could not commit to immediately doing so. We reiterate the importance of immediately establishing an expert committee and maintain that HHS could use an existing committee, which would help streamline the process and leverage existing resources, to help inform the federal government’s response to the pandemic with more complete and consistent COVID-19 data.

Providers generally reported sufficient PPE at current levels with some reuse, but were less confident of future availability for certain items. Most of the 166 hospitals that responded to our survey reported having an adequate 7-day supply of the 11 types of PPE we asked about in our survey. (See figure below.) However, in some cases, hospitals reported avoiding shortages only with reuse or extending the use of the items. [265]