Public Health Response

Medical Supply Chain

• Helping preserve existing supplies. The Advisory Group worked with CDC and the Food and Drug Administration (FDA) to provide guidance to health care providers and others on PPE decontamination and equipment efficiencies, such as techniques for using one ventilator to provide oxygen to two individuals simultaneously.[15]
• Accelerating the delivery of supplies. On June 30, 2020, FEMA concluded its operation of Project Air Bridge, which expedited the delivery of materials from overseas, such as masks and gloves.[16] Additionally, based on the Advisory Group’s efforts to understand national demand, HHS and FEMA used DPA Title I authorities to place priority ratings on at least 18 contracts from March through May 2020 to acquire ventilators, N95 respirators, and other face coverings, with most types of items scheduled to be delivered by August 31, 2020.[17] DPA Title I authorities require the contractor (and the contractor’s supply chain) to provide preferential treatment to fulfill the delivery requirements of the rated contract or order.
• Expanding the production of supplies. The Advisory Group and others have continued efforts to increase the domestic production of supplies. For example, as of August 15, 2020, DOD had used DPA Title III authorities and other funds to award about $627 million on 17 projects to expand domestic production of medical (including testing) supplies, such as N95 respirators, testing kits, and swabs.[18]
  These efforts to increase supply production will also help HHS accumulate stockpiles to prepare for future shortages when current demand for supplies abates. Specifically, HHS intends to build a 90-day supply of PPE in the SNS, including N95 respirators, gloves, and testing supplies, in case of an increase in COVID-19 cases.[19]
• Gathering data to help allocate scarce supplies. To aid in the allocation of PPE, the Advisory Group gathered supply and demand data from a variety of sources, including interagency partners and industry. For example, by obtaining and aggregating proprietary information on supply orders to, and fulfillments from, the six largest domestic medical supply distributors, officials said they received real-time information on the movement of critical medical supplies and a sense of gaps and shortfalls in supplies.[20] The Advisory Group transitioned this data collection effort to HHS, and ASPR officials told us the transition was completed September 1, 2020.

• Nursing home distributions. FEMA also coordinated the delivery directly to Medicare- and Medicaid-certified nursing homes of a 14-day supply of gloves, surgical masks, gowns, and eye protection from May through August 2020. Additionally, in July 2020, HHS announced that it would provide point-of-care testing devices and kits to all nursing homes across the country, beginning with distribution to 2,000 prioritized nursing homes.[21] According to HHS’s Daily Communications Report, as of September 3, 2020, the federal government had shipped 9,894 nursing homes almost 3 million tests and 10,637 testing instruments.
• Monthly state testing allocations. According to HHS officials, states received monthly allocations of certain testing supplies based, in part on each state’s testing plan, utilization of supplies from the prior month, epidemiological indicators, and logistical considerations. HHS officials also said that states are able to request additional testing supplies when needed, which HHS makes every effort to accommodate.
  Additionally, CDC’s International Reagent Resource continues to distribute reagents—substances needed to process tests—and other resources to public health laboratories; CDC officials told us they are able to fulfill 90 percent or more of the requests they receive.[22]
• Federal delivery deferrals. According to Advisory Group officials, the federal government is renegotiating contracts with some of its manufacturers to defer delivery of N95 respirators to federal warehouses to help ensure supplies are available on the commercial market. Additionally, the government will work with the manufacturers to allocate those supplies to nursing homes, hospitals, and other groups that had not been previously prioritized, such as dentists’ offices.

• FDA announced a list of devices determined to be in short supply. On August 14, 2020, FDA published a list of devices—PPE, testing supplies and equipment, and ventilation-related products—that it had determined to be in shortage during the duration of the COVID-19 pandemic (see fig. 4).[27] The Advisory Group and FEMA officials also acknowledged the constrained availability of supplies, in part due to limited U.S. manufacturing and high global demand. For example, FEMA stated that the agency had open requests from state, local, tribal, and territorial governments for more than 139 million nitrile gloves (which Advisory Group officials said were not domestically manufactured), 11 million surgical gowns, and 6 million N95 respirators, as of August 4, 2020.[28] FEMA also noted that the supply of N95 respirators for medical use is not expected to catch up to demand until January 2021. Officials within HHS’s Office of the Assistant Secretary for Health (OASH), who lead federal efforts to support states in their COVID-19 testing plans, acknowledge that there are testing supply shortages. In particular, they noted shortages around some of the more efficient testing platforms requiring specialized and proprietary supplies.

• Officials from seven of eight states interviewed in July and August 2020 and stakeholder groups we interviewed also identified ongoing constraints around certain types of PPE. For example, one state official told us that the state was unable to fulfill local entities’ requests for N95 respirators and nitrile gloves, but that the state had a sufficient supply of other items, such as face shields.
  Additionally, two states’ officials we interviewed expressed concern about the uncertain path of the virus and the impact of a fall surge on supply availability. As such, while the commercial market is currently the route for most states to obtain supplies, some state officials told us they plan to continue to request supplies from FEMA for items with more limited availability.
• Information reported by nursing homes and medical provider associations also indicated ongoing specific constraints with PPE. According to data that nursing homes self-reported to CDC, about 22 percent of nursing homes reported they did not have a 1-week supply of at least one or more of the following: N95 respirators, surgical masks, gloves, eye protection, or gowns, as of July 26, 2020. The American Nurses Association surveyed both members and nonmembers in late July and early August about their PPE experiences over the prior 2 weeks. Their results found that 88 percent of the over 14,000 responding nurses reported being required or encouraged to reuse single-use N95 respirators. For those who reported reusing N95 respirators, 62 percent expressed concerns about their safety as a result. Additionally, the biggest obstacle to physicians reopening their practices is “ongoing shortages of PPE, especially N95 masks and gowns,” according to a June 30, 2020, American Medical Association letter to the Vice President, who leads the White House Coronavirus Task Force.[29]
• States and associations also report pervasive testing supply shortages. Consistent with FDA’s reporting of key testing supply shortages for the duration of the pandemic, officials from seven of the eight states we interviewed in July and August 2020 identified previous or ongoing shortages of testing supplies, including swabs, reagents, tubes, pipettes, and transport media.[30]
  The Association of Public Health Laboratories reported in early August that 23 percent of public health laboratories reported they would run out of reagents or other testing supplies within a week.[31] Officials in six of the eight states we interviewed identified difficulty acquiring reagents and test kits from the commercial market, and one state official noted that challenges obtaining testing supplies have grown with the increase in testing demand across the country. Hospitals in Arkansas have had to limit their COVID-19 testing to 10 percent of full capacity due to a shortage of reagents, according to a July 2020 letter from members of the Arkansas congressional delegation to the Vice President.[32] Furthermore, officials from three of eight states and two stakeholder groups that we interviewed in July and August identified plastic supplies such as pipettes as a new type of item in shortage.
  In HHS’s initial COVID-19 Strategic Testing Plan, submitted to Congress in May 2020, HHS did not identify specific actions it or other federal agencies would take to address certain testing supply shortages.[33] For example, the May COVID-19 Strategic Testing Plan stated that because an efficient reagent marketplace was already in place, the federal government did not intend to purchase and distribute reagents on behalf of states; however, we heard from several states that they were experiencing reagent shortages.
  The subsequent COVID-19 Strategic Testing Plan, submitted to Congress in August 2020, outlined recent actions that the federal government had taken to enhance the testing supply chain, including using DPA authorities for supplies such as reagents, and that HHS would consider further use of DPA authorities moving forward.[34] However, the August COVID-19 Strategic Testing Plan did not identify actions to address pipettes and other plastic supplies that states and stakeholders have recently reported to be in short supply.

• ASPR officials noted that “shortages” are subjective and depend upon several factors, including the amount and target number of days of supplies the state or hospital has determined to stockpile, or the time that it takes between requesting and receiving supplies—a perspective echoed by Advisory Group officials.
• FEMA and ASPR officials noted that state, local, tribal, and territorial governments have overestimated their needs for supplies. For example, ASPR officials noted that one state with a population of around 11 million people overestimated its need by requesting approximately 15 million N95 respirators. FEMA officials said it was difficult for states and others to assess their true resource needs, in particular, earlier in the pandemic. This exacerbated the view that shortages existed, which in turn may have led to current needs being exaggerated in the volume of open requests for supplies, according to ASPR officials.
• Some federal officials and stakeholders we spoke with noted that testing supply shortages can be fluid in nature. Many components are required to run a laboratory-based test, and many testing instruments require specialized and proprietary supplies to operate. According to some state officials, the market can experience a shortage in supply for one component that is then resolved, only to be followed by the shortage in supply of another component. For example, one state reported that early in the pandemic response, there were reported shortages of swabs, but as those shortages resolved, shortages of other instrument-specific items, such as reagents, emerged.

• assessing critical medical supply chain requirements and gaps,
• identifying and implementing strategies to resolve and mitigate gaps and shortfalls between production and supplies, and
• developing contingency capacity and capability to address future gaps or shortfalls.[35]

• In May 2020, the President signed an Executive Order authorizing the Chief Executive Officer of the International Development Finance Corporation to make loans and take other actions to expand domestic production of strategic resources to respond to the pandemic.[36]
• In August 2020, the President signed an Executive Order intended to increase domestic production of essential medicines, medical countermeasures including PPE, and their critical inputs.[37] It directs the FDA Commissioner, in consultation with the Director of the Office of Management and Budget, ASPR, the Assistant to the President for Economic Policy, and the Director of the Office of Trade and Manufacturing Policy, to create a list of these items within 90 days. It also directs federal agencies to take various steps to increase domestic production of these items.

• Responsibility for procuring and distributing testing swabs and transport media to states transitioned from FEMA to HHS’s OASH in July 2020, according to HHS officials.
• Responsibility for monitoring commercial supply availability to, for example, inform procurement decisions by analyzing data from domestic medical supply distributors transitioned from the Advisory Group to ASPR in September 2020, according to ASPR officials.
• Responsibility for other supply acquisition conducted by DOD on behalf of ASPR—including market research, contract solicitation, proposal evaluation, and contract execution—will begin to transition to ASPR in September. In preparation for this transition, DOD is currently guiding ASPR staff on these activities, according to officials from both agencies.
• Responsibility for fulfilling state, local, tribal, and territorial governments’ requests for supplies and other resources will transition from FEMA to the SNS, according to HHS officials and documentation we received from ASPR.[38]

• Knowing when or which supplies will arrive. Officials from the majority of 10 states we interviewed, as well as officials from one FEMA regional office and an association representing emergency managers, described challenges regarding deliveries.[41] For example, an official from one state described frustrating experiences verifying the delivery of supplies and said that manifests containing tracking information often arrived several days behind the arrival of the actual shipment. The official noted that the people delivering federal supplies did not provide estimated times of arrival and said that on multiple occasions, the delivery went to a place other than the expected delivery site, requiring state officials to respond to phone calls at 2 or 3 a.m. to help manage the resulting confusion.
  An official from another state similarly described frustrations with uncertainty about when PPE would be delivered, saying that even a number of months into the response, the state's staff cannot say with any confidence when items will arrive; rather, shipments “just show up” without advance notice.
• Tracking deliveries made directly to local points of care. Officials from the majority of the states we interviewed, as well as officials from one FEMA regional office, reported having trouble confirming that the right entities received correct and usable supplies when supplies provided through federal programs arrive directly at local points of care, such as hospitals, laboratories, or nursing homes. For example, officials from one state described trying to track supplies delivered directly to medical facilities, and after raising the issue with FEMA and HHS representatives, received only a list of which counties received the supplies but not the specific facilities where those supplies were delivered. Another state official in a different FEMA region said that the FEMA regional office provided information stating that FEMA had shipped supplies to somewhere in the state, but the information did not specify where the supplies went or to whom they were delivered.
• Budgeting for ongoing supply needs. State officials described challenges determining how to best apply funding from various federal programs and make budgeting decisions for future supply needs:
  • Officials from the majority of the 10 states we interviewed expressed concerns and frustrations over uncertainty about whether and to what extent states and other recipients would be responsible for sharing the cost of supplies provided by the federal government. Officials from the majority of FEMA regional offices we interviewed also described states’ confusion about reimbursement, cost share responsibility, and concerns about potential duplication of benefits.
    FEMA generally reimburses 75 percent of the eligible cost of medical supplies that states purchase under its Public Assistance program and received through mission assignments.[42] Conversely, supplies that states and other recipients receive directly from the SNS are covered at 100 percent and are not subject to cost sharing. To illustrate, officials from at least two states described being uncertain as to which supplies and delivery efforts were provided by FEMA programs and which were provided through another federal channel because shipments did not always contain paperwork indicating the provider, compounding confusion about whether their states would be responsible for sharing the cost for such supplies and activities.
  • State officials also reported that different timelines and guidance for FEMA’s Public Assistance Program and the CRF make it difficult for nonfederal entities to optimize resources from these programs. Certain supplies are eligible under both programs.
    In addition, the Department of the Treasury (Treasury) has provided information describing use of the CRF to meet the nonfederal cost share for FEMA assistance. Therefore, state, territorial, and tribal officials have to make decisions about the best way to apply these funds to meet their medical supply needs. According to one state official, the different timelines and requirements for each program, particularly the requirement that payments from the CRF may only be used to cover costs incurred by the end of calendar year 2020, have made deciding the best way to use these funds challenging. [43] Completing Public Assistance projects typically takes time, and users can face delays during the review and approval process.

Testing Capacity

• Continued federal expenditures for testing. The COVID-19 relief laws appropriated a total of $26.5 billion to HHS to support COVID-19 testing. HHS reported total testing-related obligations of about $14.35 billion as of July 31, 2020, and total expenditures of $1.17 billion.[50] See table 1 for HHS-reported obligations and expenditures for testing-related activities.

  Table 1: HHS’s Reported Obligations and Expenditures for Testing-Related COVID-19 Response Activities, as of July 31, 2020

  Key Activity	Obligations ($ billions)	Expenditures ($ billions)	Percentage of obligations expended, as of July 31, 2020
  Support to state, local, territorial, and tribal organizations’ preparedness	$12.690	$0.867	7%
  Testing for uninsured	0.163	0.161	99
  Testing	1.496	0.137	9
  Total	14.349	1.165	8

  Source: GAO analysis of Department of Health and Human Services (HHS) information. | GAO-20-701

  Note: the percentages represent the share of obligations for each key activity that were expended as of July 31, 2020.

  We requested information from HHS to explain why expenditures represent a small share of total obligations. HHS responded that it was primarily due to the slow rate at which states have used the funds they were awarded; however, HHS’s response did not address why its expenditures of amounts allocated for federal testing activities comprised 9 percent of its obligations. HHS noted that the length of time it will take to spend all federal appropriations allocated for testing is highly dependent on the progression of the COVID-19 pandemic and its impact on specific U.S. geographic locations and populations.
  The Paycheck Protection Program and Healthcare Enhancement Act required each state, territory, or local jurisdiction receiving funding to submit to HHS a plan for how they will meet their testing targets.[51] Officials from states we interviewed told us they intend to use these funds to support testing in various ways, such as by procuring additional testing supplies when available, creating partnerships with local private sector entities to expand testing capacity, improving mobile testing capacity, expanding the laboratory and epidemiological workforce, and investing in information technology upgrades. HHS officials told us that the funding is available to recipients for 30 months and is expected to be expended over time.
• Enhanced support for testing supplies. As described above, FEMA and HHS have continued to procure swabs, transport media, and point-of-care tests on behalf of states and territories. FEMA and HHS also procured point-of-care tests on behalf of certain federal agencies.[52] HHS will continue to procure these supplies through December 2020.
• Invested in new testing technologies. In late July, the National Institutes of Health's (NIH) Rapid Acceleration of Diagnostics (RADx) initiative awarded contracts totaling nearly $250 million to seven companies to support new testing technologies. NIH stated that these investments have the potential to increase the number, type, and availability of tests by fall 2020.[53] Four of the technologies could increase testing capacity while reducing the time to receive test results. Three of the technologies use platforms that can give rapid results in non-laboratory settings, such as work sites, nursing homes, and schools. In early September, NIH announced an additional round of awards totaling over $129 million to nine companies.[54]
• Invested in capacity expansion for two laboratories. On August 13, 2020, HHS announced a $6.5 million dollar investment in two commercial laboratories.[55] Specifically, the agency is providing these companies with resources, such as testing equipment and supplies, to increase testing capacity by up to an additional 4 million tests per month starting in early October.
• Expanded support for testing sites. HHS established public-private partnerships with a commercial laboratory company and retail pharmacy and grocery store chains to implement and reimburse testing through August 2020.[56] As of mid-August, these sites had tested more than 1.6 million individuals, according to HHS documentation. In addition, HHS set up surge temporary testing sites in multiple communities to increase federal support in areas with recent spikes in new cases and hospitalizations.[57]
• Clarified guidance and implemented enforcement mechanisms to enhance testing data. Shortly before the August 1, 2020 testing data reporting deadline, HHS published implementation specifications with standard definitions for all of the data that laboratories are required to report to CDC through state and territorial health departments.[58] These specifications are aimed to help improve the quality of testing data CDC receives, and in turn allow the agency to more accurately monitor testing. According to CDC, 40 of the 56 states and territorial jurisdictions had completely developed the capability to relay detailed testing data to CDC as of August 24, 2020.
  To improve consistency and uniformity in the reporting of testing data, on September 2, 2020, CMS published an interim final rule that provides sanctions for laboratories that fail to report COVID-19 testing data consistent with the form and manner specified by HHS.[59] We will monitor the implementation of this guidance in our ongoing work.

• In early July, LabCorp announced on its website that its average time to deliver test results was 4 to 6 days, citing constraints in the availability of supplies and equipment.[60]
• Quest Diagnostics announced in late July that the average turnaround time for reporting test results had increased to 7 days or more for nonpriority populations.[61]

• In the HHS COVID-19 Strategic Testing Plan, submitted to Congress on August 22, 2020, HHS stated that communities seeing increased turnaround times for test results may choose to prioritize testing to only those who “need” a test according to CDC or state and local guidelines; however, HHS did not define who needs a test in this plan. Subsequently, on August 24, CDC revised its testing guidelines to state that asymptomatic individuals with a known exposure to COVID-19 do not necessarily need a test unless they are a vulnerable individual or their health care provider or state or local public health officials recommend a test. Further, the revised guidelines stated that asymptomatic individuals without a known exposure do not need to be tested.[65]
  Several public health organizations, including the American Medical Association, the National Association of County and City Health Officials, and others, have expressed concern over CDC’s guidelines for asymptomatic people who have been exposed to COVID-19, citing the need for a rationale for the change. For example, the Association of American Medical Colleges expressed concern that the new CDC guidelines will result in less testing of asymptomatic individuals, who may go on to infect others if they carry the virus. GAO will continue to monitor this issue.
• Several states, including Alabama, California, Michigan, Minnesota, and Virginia, have issued guidelines for prioritizing testing of certain populations, such as people requiring hospitalization and health care workers. Guidelines from California, Minnesota, Michigan, and Virginia recommend prioritizing testing for asymptomatic individuals who are close contacts of confirmed COVID-19 cases.
• In May 2020, the University of Minnesota’s Center for Infectious Disease Research and Policy noted that the need for testing will likely far outpace capacity, particularly during surges, and recommended prioritizing testing based on CDC guidelines at that time.[66]

• Public health researchers from the Rockefeller Foundation and Harvard University have called for an increased use of antigen tests in a screening capacity, including among asymptomatic individuals, noting that this approach would be useful when re-opening certain settings, such as schools and large workplaces.
• In July and August 2020, the federal government awarded contracts to manufacturers of three antigen tests to purchase or increase production of these tests. For example, HHS awarded a contract for the delivery of 150 million Abbott BinaxNOW COVID-19 Ag Card Point of Care tests, with the intention of distributing them for testing at schools and for testing other special needs populations.[73] Also, in August 2020, 10 states joined together to conduct group purchasing of 5 million antigen tests.[74]

Vaccine and Therapeutics Development, Manufacturing, and Distribution

• HHS and DOD have announced a total of about $12.6 billion in awards to support Operation Warp Speed and to accelerate the development, manufacturing, and distribution of COVID-19 vaccines and therapeutics, as of September 1, 2020.[77] For example, HHS and DOD announced an award of a $138 million contract for the production of more than 100 million prefilled syringes by the end of 2020.
• Manufacturing capacity is being advanced for selected Operation Warp Speed vaccine candidates while they are still in development; typically, large-scale manufacturing of vaccine occurs after it is shown to be safe, pure and potent (i.e., safe and effective). According to HHS, the federal government is taking a financial risk by manufacturing certain selected vaccines before information about the vaccines’ safety and efficacy is known to ensure vaccines are available as soon as possible, once such information is determined.
• A memorandum of understanding between DOD and HHS states that DOD will coordinate the logistics, supply chain, development, and manufacturing of vaccines and therapeutics in support of Operation Warp Speed, among other things.

• As of August 18, 2020, BARDA had awarded about $10.8 billion in support of seven vaccine candidates; these awards included support for the development, manufacturing, and purchase of vaccine doses. Of these seven vaccine candidates, one was in phase 1 of clinical trials, one was in phase 1 and phase 2 of clinical trials, one was in phase 2, three were in phase 3, and the remaining vaccine candidate was not yet in clinical trials, as of September 3, 2020.[78]
• BARDA also awarded about $1 billion for nine therapeutic candidates as of August 18, 2020, and two of these candidates were in phase 1 of clinical trials, one was in phase 2 of clinical trials, and one was in phase 3 trials as of September 1, 2020. In addition, two therapeutics that received BARDA awards had been in phase 3 clinical trials but were no longer supported by BARDA.[79]

• HHS and DOD announced that McKesson Corporation will be a central distributor of COVID-19 vaccines and related supplies in support of Operation Warp Speed. McKesson, which distributed the H1N1 vaccine during the H1N1 pandemic, will work under CDC’s guidance to deliver COVID-19 vaccine to administration sites, according to HHS and DOD announcements released on August 14, 2020.
• HHS has announced it is planning a tiered approach for vaccine distribution. This tiered approach will build on a methodology developed as part of pandemic influenza planning and will be adjusted based on experience during the first wave of the COVID-19 response, among other things, according to an Operation Warp Speed Fact Sheet.
• CDC and NIH have sponsored a committee of experts to develop a framework to assist policymakers in planning for the equitable allocation of COVID-19 vaccine. This committee—convened through the National Academies of Sciences, Engineering, and Medicine and the National Academy of Medicine—held its most recent public meeting in early September 2020. On September 1, 2020, the committee released a discussion draft of a potential allocation framework for public comment.[82] The committee’s final report, expected early this fall, will include a final recommended allocation framework, according to a press release announcing the draft framework. The press release also noted that the committee’s final report will address related issues, such as vaccine hesitancy, demand, and promotion as well as risk communication and strategies for community engagement.[83]
• CDC’s Advisory Committee on Immunization Practices has established a COVID-19 vaccine work group to consider approaches for vaccine distribution.[84] This work group intends to collect, analyze, and prepare information related to COVID-19 vaccines for presentation, discussion, deliberation, and vote by the advisory committee.[85] It is expected to make recommendations on the groups for vaccine prioritization to CDC and HHS leadership.[86] As of August 26, 2020, these recommendations had not yet been made. According to HHS, the advisory committee recognizes that vaccine prioritization will be an iterative process that will be continually refined as more information about the COVID-19 virus, vaccines, and vaccine availability becomes known.
• CDC sent early distribution planning documents to states. CDC sent several documents to state and local jurisdictions in late August 2020 to help them prepare for COVID-19 vaccination. These documents include (1) planning scenarios for state and local jurisdictions to use to develop operational plans for early COVID-19 vaccination when vaccine supply may be constrained, (2) planning assumptions, such as the potential timing for initial availability of a vaccine and storage and handling requirements, and (3) a checklist of early planning action items, such as identifying existing community vaccination providers.

• Representatives said they would need time to enroll additional providers if a COVID-19 vaccine is distributed using the established immunization network that was used during the H1N1 pandemic in 2009.[87]
• It will be important to consider if using uniformed military personnel will improve or undermine confidence in a COVID-19 vaccine, if DOD is expected to play a role in vaccine distribution and administration. This is particularly true in certain minority and underserved communities, where trust in the medical and political systems is strained, according to state, local, and territorial health officials.
• Advanced planning will be needed to develop and disseminate clear public health messaging to help ensure public acceptance and uptake of the vaccine. It will be important to address vaccine hesitancy for people concerned about the safety or effectiveness of the vaccine and to manage expectations about vaccine availability, according to representatives of state, local, and territorial health officials and immunization managers.[88]

HHS Efforts to Collect COVID-19 Data by Race and Ethnicity

• Testing. CDC publishes data on COVID-19 testing results on its website, such as the total number of positive tests out of the total number of tests reported. However, it does not include results by race and ethnicity, as these data are not typically collected by laboratories or sent to laboratories by providers, according to some stakeholders we interviewed.[93] We previously reported that since August 1, 2020, all laboratories have been required to report data on COVID-19 test results by race and ethnicity to CDC.[94] On July 31, 2020, HHS published guidance with standard definitions for all information that should be included in testing data, including categories to be used for race and ethnicity data.[95]
• Cases. CDC collects and makes available data on COVID-19 cases, including those that are probable or confirmed, from state and jurisdictional health departments. However, as of July 31, 2020, race and ethnicity data were not available for more than half—52.6 percent—of cases with case report forms received by CDC, or 63.8 percent of total cases reported.[96] CDC officials stated that they have worked with state and local partners to improve the completeness of demographic data, including race and ethnicity, obtained through case reporting.
  In addition, CDC updated its epidemiological case report form on May 15, 2020, to encourage state and jurisdictional health departments to report more detailed demographic case data, including race and ethnicity, when reporting case information.[97] CDC is also working to expand electronic case reporting through an initiative called Electronic Case Reporting Now, which the agency expects will improve the completeness of race and ethnicity data for cases.[98]
• Hospitalizations. CDC collects and makes available data on COVID-19 hospitalizations, including by race and ethnicity. CDC’s COVID-19-Associated Hospitalization Surveillance Network (COVID-NET) makes data available on hospitalizations by race and ethnicity. However, as of August 1, 2020, these data were limited to approximately 10 percent of the U.S. population because the data represent select counties in 14 participating states.[99] CDC also collects data on hospitalizations from states and jurisdictions that voluntarily report cases; however, according to CDC officials, these data are incomplete.
• Deaths. CDC collects and makes available data on COVID-19 deaths through death certificates collected in the National Center for Health Statistics’ National Vital Statistics System (NVSS).[100] According to CDC, as of August 7, 2020, data on race and ethnicity were available for almost all (over 99 percent) of COVID-19 deaths reported through this system.
  CDC also collects and makes available data on deaths reported to the case surveillance system from state and jurisdictional health departments. However, CDC reported that as of July 30, 2020, several states did not provide data on race and ethnicity for deaths reported through case reporting. Race and ethnicity data were available for 83.4 percent of deaths with case report forms received by CDC, or 64.6 percent of total deaths reported through case reporting, as of July 31, 2020.[101] According to CDC, it is important to have complete data on deaths by race and ethnicity through case reporting because these data are generally available 2 weeks before data reported through NVSS, allowing state and jurisdictional health departments to identify trends more rapidly.

• Testing. HHS’s testing guidance requires laboratories to report demographic data and recommends that health care or other providers, such as public health testing providers who do not require a doctor’s order, report demographic data to laboratories. However, some stakeholders we interviewed said it would be difficult for laboratories to comply with HHS’s guidance on testing because providers may not collect demographic data from patients at the point of care and are unlikely to do so unless there are requirements or incentives associated with capturing these data.[102]
  To help address these difficulties, CDC officials stated that the agency has conducted outreach to provider organizations such as the American Medical Association to offer education and assistance on collecting testing data. HHS officials stated that ongoing support for health care providers will be needed to help ensure complete and consistent collection and reporting of testing data.
• Cases. CDC encourages state and jurisdictional health departments to report information on race and ethnicity through its case report form, but agency officials stated that CDC does not have the authority to require the reporting of this information. Further, CDC may not be receiving consistent race and ethnicity data on cases.
  HHS reported that as of June 25, 2020, 21 state health departments reported race for cases using combined categories, such as including American Indian/Alaska Native and Native Hawaiian/Pacific Islander in an “Other” category.[103] CDC noted that while its case report form includes these two racial groups as separate, state and jurisdictional health departments may report categories for race and ethnicity as “Other” within their state or jurisdictional case reporting systems. HHS stated that it is important to separate data on these two racial groups for testing and all indicators of COVID-19 burden, including cases, hospitalizations, and deaths. HHS explained that the practice of grouping race categories together into an “Other” category can disguise issues that may be unique to specific minority populations, which can further exacerbate existing disparities.
• Hospitalizations. CDC officials stated that the agency does not have plans to require hospitals to report race and ethnicity data for hospitalizations because it does not have the authority to do so. HHS recently released guidance that directs hospitals to provide hospital capacity and utilization data directly to HHS, rather than to CDC; however, this guidance does not include a requirement for hospitals to include race and ethnicity information in their reporting to HHS.[104] Although CDC officials stated that the agency’s collection of hospitalization data, including race and ethnicity information, through COVID-NET has not been affected by this guidance, COVID-NET is limited to 14 participating states, and CDC officials noted that the agency has no immediate plans to expand it to additional states.
• Deaths. CDC officials stated that the agency does not have plans to require states to report race and ethnicity data for deaths reported through the case surveillance system because it does not have the authority to do so.

• CDC officials noted that electronic systems that share data between providers, laboratories, and state and jurisdictional public health departments are often not compatible, resulting in difficulties in transferring complete information on race and ethnicity for testing and indicators of COVID-19 burden. For example, officials stated that information on race and ethnicity from patients’ medical records may not be transferred electronically to laboratories when providers order tests. Further, the officials said that some state and jurisdictional public health departments are not able to automatically incorporate laboratory results, including any associated demographic data such as race and ethnicity, directly into their electronic surveillance systems for case reporting.
• In addition, CDC does not have a comprehensive mechanism to assess the long-term health outcomes of people who have had COVID-19, including by race and ethnicity, to identify potential long-term health effects, such as heart, brain, or lung abnormalities over many months and years. CDC stated that it is funding several studies, including a cohort study that will follow 3,900 patients with COVID-19 6 months after infection, to assess potential complications from COVID-19, including by race and ethnicity. Two additional studies will examine long-term health outcomes of persons with COVID-19 in specific groups, such as American Indian populations. However, these studies are limited to specific groups and time frames, so they are not able to identify long-term health outcomes across other population subgroups that are not included.
  Some research institutions have recommended the formation of registries that identify and follow individuals who have had COVID-19 over time to better understand the long-term effects on individual and population health.[105] Further, it may be important for CDC to coordinate with other HHS agencies, such as NIH, which conducts and funds long-term public health studies. Assessing the long-term effects of COVID-19 is particularly important for groups who are disproportionately affected by COVID-19, such as racial and ethnic minority groups, to effectively direct care, inform interventions, and tailor public health messaging to these communities.

Assistance to Individuals

Economic Impact Payments

• Non-filers with qualifying children. We reported in June 2020 that individuals who used the Non-Filers tool between April 10 and May 17 did not receive a payment that included additional money for qualifying children.[125] As of July 24, IRS identified 355,103 non-filers who received an individual payment but were still waiting to receive an additional $500 per qualifying child. On August 5, IRS stated on its EIP FAQ webpage that impacted non-filers were to receive the payment via direct deposit on August 5, and paper checks or debit cards were scheduled to be mailed August 7.
  Additionally, IRS recently announced a policy change that should allow some eligible recipients to receive supplemental payments for qualifying children sooner than expected. As we previously reported, the benefit data IRS had used to automatically send payments to non-filers did not include information on qualifying children, so those recipients were asked to use the Non-Filers tool. However, Social Security and RRB benefit recipients, who comprised nearly 14 million EIP recipients, were given only a few days’ notice to add in information about qualifying children before they would no longer be able to do so. VA and SSI benefit recipients had 2 weeks to add qualifying children and totaled 2.5 million payments by the time of the deadline.
  Initially, IRS announced that those who missed the deadline would have to wait to file a tax return in 2021 to get a payment for qualifying children.[126] However, the CARES Act requires Treasury and IRS to make the payments as “rapidly as possible.”[127] Waiting 9 to 12 months before an individual or family receives a complete payment during the 2020 tax filing season would not provide the immediate relief intended by the law. Therefore, in the course of our audit work, we asked IRS officials whether they planned to reopen the Non-Filers tool to those individuals who missed the deadline to provide EIPs for qualifying children of non-filers sooner than 2021. IRS officials said they could not reopen the tool to those who missed the deadline to add qualifying children because they would have to manually process the additional information and they lacked the resources to do so, given backlogs caused by the COVID-19 closure of IRS service centers.
  On August 14, IRS changed this policy with an announcement that it would reopen the registration period. Federal beneficiaries who did not previously receive $500 per qualifying child now have until September 30, 2020, to enter information on their qualifying children and receive the supplemental $500 payments.[128] According to IRS officials, IRS figured out an automated solution that would allow IRS to add information to payments already made. Opening the registration period and extending it through September 30 allows more eligible recipients to seek the financial relief to which they are entitled and owed by law.
• Injured spouses and domestic abuse survivors. IRS is also taking action to issue payments to injured spouses—married taxpayers whose payments were used to cover the past-due child support of a spouse or ex-spouse. As of July 31, 2020, IRS estimated that 49,522 individuals filed an injured spouse claim and may be owed an adjustment. On August 25, IRS announced these catch-up payments will be mailed as checks to any eligible spouse the week of August 31. [129]
  There also may be some eligible EIP recipients who are domestic abuse survivors but may not have been able to claim their portion of the EIP if it was provided to an individual’s bank account or address to which eligible recipients do not have access. IRS said it is considering options that may provide relief to domestic abuse survivors, including outreach to advocacy groups for victims of domestic abuse who can advise survivors of legal and other options they can pursue in such situations.
• Widows, widowers, and spouses of deceased and incarcerated individuals. In some cases, Treasury stopped payments to surviving spouses before they were disbursed to account for the death or incarceration of a spouse. IRS did not yet have an estimate of the number of spouses of incarcerated individuals who had their portion of the payment stopped. IRS also estimates nearly 700,000 individuals may have had their payment stopped due to being the spouse of a decedent. IRS plans to pay the eligible spouses by late summer.

Unemployment Insurance

• Pandemic Unemployment Assistance (PUA) program. Generally authorizes up to 39 weeks of UI benefits to individuals not otherwise eligible for UI benefits, such as self-employed and certain gig economy workers, who are unable to work as a result of COVID-19, available through December 2020.[132]
• Federal Pandemic Unemployment Compensation (FPUC) program. Generally authorized an additional $600 benefit that augmented weekly UI benefits available under the regular UI program, as well as CARES Act UI programs, through July 2020.[133]
• Pandemic Emergency Unemployment Compensation (PEUC) program. Authorizes an additional 13 weeks of UI benefits to those who exhaust their regular UI benefits, available through December 2020.[134]

Assistance to Industry and the Economy

Paycheck Protection Program

• SBA’s interim final rules on loan forgiveness and a procedural notice issued on July 23, 2020, indicate that the lender is to review the borrower’s application for loan forgiveness and make the decision on forgiveness.[160] However, the extent of lender review required is unclear.[161] Prior to making the decision, lenders are expected to perform a “good-faith review” in a reasonable amount of time of the borrower’s calculations and supporting documents and confirm the borrower’s calculations concerning amounts eligible for loan forgiveness. The interim final rules and procedural notice do not clearly define the extent of review required but one rule provides an example.[162] At the same time, the loan review procedures interim final rule and the procedural notice state that an accurate calculation of the loan forgiveness amount is the responsibility of the borrower and that lenders may rely on borrower representations.
  On August 4, 2020, SBA posted responses to frequently asked questions on loan forgiveness that answer technical questions, but do not address broader questions about lenders’ role. After SBA issued additional guidance in July and August 2020, representatives of two lender associations we interviewed still had questions or concerns about the lender’s role in the forgiveness process, including the level of review required and the extent to which lenders could rely on borrower certifications and calculations.
• In its July 23, 2020, procedural notice, SBA noted that it had contracted with a company to develop and make available a secure platform for lenders to submit loan forgiveness decisions, supporting documentation, and requests for forgiveness payments.[163] SBA launched the platform on August 10, 2020. SBA officials told us they did not expect to receive a large number of loan forgiveness decisions from lenders until early August 2020 due to the timing of the CARES Act and SBA rules.[164]
• According to SBA officials, as part of its oversight SBA will put all lender decisions granting full or partial loan forgiveness through the automated review tool provided by one of its contractors. SBA’s interim final rule on loan review procedures and the July 23, 2020, procedural notice indicate that SBA reserves the right to direct a lender to deny an application or to review the lender’s decision.[165] As of August 14, 2020, SBA was still developing its processes for loan reviews, which include overseeing loan forgiveness.[166]

New Renters’ Relief Follows Expiration of Key CARES Act Provisions

Assistance to States, Localities, Territories, and Tribes

Coronavirus Relief Fund Guidance

Guidance for K-12 Schools

Federal Contracting

Government-wide Contract Obligations

Tracking Contract Activity

Terminated Contracts

International Response

• Pillar 1: Protecting U.S. Citizens and Maintaining U.S. Operations. State reported obligating supplemental funding to maintain consular operations, which faced a significant decline in visa and passport fees resulting from the pandemic. State planned to use supplemental funds to, among other things, increase secure communications bandwidth, accessibility, and support for those working remotely; expand cloud and email storage capacity; and support efforts by the Bureau of Medical Services to continue effectively and safely achieving State’s mission domestically and overseas by contracting for experts in areas such as infectious disease, mental health, and statistical analysis of health data. Efforts also included purchasing and distributing personal protective and testing equipment, targeted hiring, and adding capacity for medical evacuation travel and contract aviation to continue international operations in the face of reduced global commercial airline service.
• Pillar 2: Global Health Assistance. USAID reported obligating supplemental funding as of June 6, 2020, to provide global health assistance for at least 73 countries affected by and at risk of COVID-19; regional activities in the Caribbean, Pacific Islands, and Asia; and worldwide activities. This assistance included preventing and controlling infections in health facilities; conducting contact tracing; improving readiness to rapidly identify and treat cases; raising awareness in populations through risk communication; screening people at points of entry and exit; and purchasing commodities, including ventilators.
• Pillar 3: Humanitarian Assistance. USAID reported obligating supplemental International Disaster Assistance account funding as of June 6, 2020, for 11 countries, regional activities in the Pacific Islands, and worldwide activities. This funding focuses on mitigating widespread transmission of COVID-19, addressing public health consequences, and maintaining essential health services for crisis-affected populations, particularly displaced people. Assistance efforts have included support for health interventions; water, sanitation, and hygiene services; protection services, such as psychosocial support; and risk communication activities. This funding is also supporting response logistics and the response to the secondary impacts of COVID-19, including the enormous emergency food needs, according to USAID officials. In addition, State reported that it obligated supplemental Migration and Refugee Assistance account funding as of July 10, 2020, for 56 countries and regional and worldwide activities. These obligations support assistance efforts similar to those USAID has supported with International Disaster Assistance funds, but focus on the needs of specific populations of concern, including refugees, victims of conflict, internally displaced persons, stateless persons, and vulnerable migrants.
• Pillar 4: Economic and Development Assistance. USAID reported that State and USAID obligated supplemental funding under Pillar 4 as of June 6, 2020, for nine countries, as well as regional and worldwide activities.[212] Examples of activities supported include providing technical assistance and access to credit for micro, small, and medium-sized enterprises; strengthening civil society; protecting and assisting vulnerable people; monitoring legal protection for journalists; and providing direct cash relief to households.

• Host government COVID-19-related restrictions. Visa restrictions, curfews, quarantines, and movement restrictions have impeded the ability of humanitarian workers to operate in some countries. For example, according to USAID officials, Nigeria’s visa restrictions have created difficulty for relief workers to travel there, and Ethiopia has limited movements at land borders, except for the flow of cargo and essential goods. In Iraq, travel restrictions posed challenges delivering medical supplies to program sites.
• Lack of key commodities. Due to concerns around possibly diverting scarce PPE, such as surgical masks and gloves, from the domestic response to the COVID-19 pandemic in the United States, USAID officials told us that they instructed all implementing partners in early March 2020 to temporarily pause any purchases of PPE products using USAID funds. According to USAID, this pause posed challenges for implementing partners in both protecting their own staff as well as ensuring the continuity of USAID’s emergency health assistance. On June 9, 2020, USAID ended the pause by issuing interim policy guidance to allow implementing partners to procure restricted PPE materials without prior authorization in the following two situations: (1) for their staff from any source, and (2) for the protection of beneficiaries of USAID programs from PPE manufactured locally or in the same region where USAID is providing assistance as long as the PPE is not, and could not reasonably be, intended for the U.S. market.[214] Some countries may continue to face shortages of PPE, according to USAID officials. For example, USAID officials told us in early July that USAID-funded partners working in Sudan had reported that the shortage of PPE across the health sector has made it difficult for relief workers to respond safely to COVID-19.
• Lack of qualified partners or staff. For some countries with limited USAID presence, there are very few qualified partners to implement USAID-funded assistance. USAID partners have also faced challenges recruiting and training local staff to implement response activities. Additionally, USAID cited an example in which a program’s operations in Nigeria were suspended when a quarantine was imposed following the death of a relief worker who contracted COVID-19.
• Additional challenges for humanitarian assistance. According to State officials, partner organizations face several challenges to providing COVID-19-related assistance to vulnerable populations that are already in the midst of a humanitarian crisis. These challenges include limited in-person implementation and monitoring; xenophobic violence directed at aid workers, refugees, migrants, and other foreigners believed to be importing the virus; closed borders; and delays in health care delivery, among many other concerns.

Lesson: Need to Establish Clear Goals and Define Roles and Responsibilities

Lesson: Provide Clear Communication

Lesson: Need to Collect and Analyze Adequate and Reliable Data to Drive Future Decisions

Nursing Home Data

Nationwide COVID-19 Data System

Lesson: Establish Transparency and Accountability Mechanisms

COVID-19 Testing Payments

• Two states offer clear and accurate instructions that providers should bill the state Medicaid program first and that HRSA is the payer of last resort.
• One state provides opposite, and inaccurate guidance, directing providers to bill HRSA until HRSA’s funds are exhausted, at which point providers can bill Medicaid. The state’s website also provides a link for providers to access the HRSA payment website.
• Some other state websites we reviewed had more limited information on Medicaid’s optional coverage or HRSA’s provider payment program and how providers should bill the programs.

Lesson: Need to Guard against Cyber Threats

Continued Congressional Attention Needed in Several Areas