GAO Cites Need for More Transparency Around Vaccine Development and Testing, in Unemployment Numbers, and the Urgent Need to Address Medical Supply Shortages in New CARES Act Report
Washington, D.C. (November 30, 2020) –The U.S. Government Accountability Office (GAO) today issued its fourth report on the implementation of the CARES Act and other pandemic relief measures. To help improve the nation’s response, GAO is making 11 new recommendations for agencies and is raising one matter for congressional consideration. Targeted areas needing attention from the Administration and the Congress include medical supplies, vaccines and therapeutics, COVID-19 testing guidance, estimates of the number of individuals relying on unemployment insurance, nursing home care, and economic impact payments.
“GAO continues to provide policymakers with a snapshot in real time of the federal government’s efforts to address the public health and economic impacts of the pandemic,” said Gene L. Dodaro, Comptroller General of the United States and head of the GAO. “We are at a critical time in this pandemic. Our latest report makes a number of recommendations that would significantly strengthen the federal response, both now and in the coming months.” Additionally, Dodaro emphasized the need to fully implement the 19 outstanding recommendations GAO has already made in its CARES Act work.
Examples of key GAO findings and its 11 new recommendations include the following:
Medical Supplies. Although the Department of Health and Human Services (HHS) and the Federal Emergency Management Agency are working to mitigate supply shortages and expand the medical supply chain, shortages of certain items persist. GAO raised this issue previously and this time surveyed public health and emergency management officials from all states, the District of Columbia, and all territories, and found that
- Most states reported no shortages of swabs or transport media, but about one-third to one-half reported shortages in other types of testing supplies such as rapid point-of-care tests, reagents and testing instruments.
- Most states said they were largely able to fulfill requests for PPE from organizations and entities within their states. At the same time, certain items, such as nitrile gloves, remain scarce.
- About one-third of responding states indicated that they were “greatly” or “completely” concerned about having enough supplies to administer COVID-19 vaccines. An additional 21 states indicated that they were “moderately” concerned.
HHS and the Department of Homeland Security disagreed with GAO’s previous recommendations for developing a plan to address critical supply gaps and to work with states to ensure adequate supplies for the remainder of the pandemic. Given the surge of COVID-19 cases, along with reported nationwide shortages in medical supplies, GAO believes it is critically important that its recommendations be implemented.
Vaccines and Therapeutics. The federal government has made a concerted effort to speed the development of vaccines and therapeutics, as seen in Operation Warp Speed. One tool being used to spur the creation of therapeutics is Emergency Use Authorizations, which allow for the emergency use of medical products without Food and Drug Administration (FDA) approval or licensure. As of November 9, FDA had used that approach to make four treatments available for COVID-19. GAO previously recommended FDA identify ways to uniformly disclose information from its scientific review of safety and effectiveness data when issuing Emergency Use Authorizations for therapeutics and vaccines, a move that could help improve the transparency of, and strengthen public confidence in, FDA’s decisions. FDA agreed that transparency is an important goal.
COVID-19 Testing Guidance. HHS and its component agencies have taken important steps to document a federal COVID-19 testing strategy and provide testing-related agency guidance. This guidance has not always been transparent, however, raising the risk of confusion and reduced trust in government. Although guidance is expected to evolve as new information about the coronavirus emerges, frequent changes to general testing guidelines issued by the Centers for Disease Control and Prevention (CDC) have not always been communicated with a scientific explanation. HHS needs to ensure that CDC clearly discloses the scientific rationale for any change to testing guidelines at the time the change is made. HHS agreed.
Unemployment Insurance Estimates: Weekly news releases issued by the Department of Labor (DOL) do not provide an accurate estimate of the total number of individuals actually claiming unemployment insurance (UI) because they have potentially both over-estimated and underestimated the total number of individuals actually claiming unemployment insurance. That is because DOL presents state-reported data on the total count of weeks claimed, nationwide, as the number of people claiming benefits. DOL has traditionally used the total count of weeks claimed to estimate the number of individuals claiming benefits because the two numbers were a good approximation of each other. However, due to state backlogs in processing claims and other data issues, these traditional estimates are not appropriate in the context of the pandemic. For example, state backlogs in processing claims led to individuals submitting claims for multiple weeks of retroactive benefits during single reporting periods. So, by using claims counts to represent the number of people, many individuals are counted more than once in DOL’s estimate.
In addition, DOL has also inaccurately characterized changes in claims numbers from week to week, in large part because of inconsistency in the group of states reporting Pandemic Unemployment Assistance (PUA) data each period. For example, in its July 23, 2020, publication, DOL reported that the number of claims in all programs for continuing unemployment during the week ending July 4 decreased by about 200,000 from the previous week. However, Arizona did not report PUA data for that week, after reporting almost 2.3 million claims the previous week. Had Arizona submitted data, DOL likely would have reported a significant increase in claims from the prior week instead of a decrease. To understand the role UI benefits are playing in the economy during the pandemic, reliable data are needed on both the number of new claimants each week and the number of claimants who continue to rely on UI benefits. DOL should revise its weekly news releases to clarify that in the current unemployment environment, the numbers it reports for weeks of unemployment claimed do not accurately estimate the number of unique individuals claiming benefits. DOL agreed.
As part of this report GAO also made numerous other recommendations, including areas related to Veterans Affairs oversight of nursing homes, economic impact payments, electronic filing capability for tax year 2019 and improvements in tracking improper payments. The agencies disagreed with one of the 11 new recommendations.
Four relief laws, including the CARES Act, have provided funding to address the public health and economic threats posed by COVID-19. As of September 30, federal agencies reported that they had obligated $1.8 trillion and expended $1.6 trillion of the $2.6 trillion in COVID-19 relief funds. GAO is required to report regularly on its efforts to monitor and oversee the response to the COVID-19 pandemic.
For more information, contact Sarah Kaczmarek, Director of GAO Public Affairs, at kaczmareks@gao.gov or (202) 512-4800.
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