Ensuring a Transparent, Thorough Investigation of COVID-19’s Origin

Michael R. Pompeo, Secretary of State

The United States has repeatedly called for a transparent and thorough investigation into the origin of COVID-19. Understanding the origin of this pandemic is essential for global public health, economic recovery, and international security.

To assist the vital work of the World Health Organization (WHO) investigative team that arrived in China this week, the United States government is today sharing new information concerning the activities inside China’s government laboratories in 2019.

In particular, we urge the WHO to press the government of China to address the following:

  1. Illnesses at the Wuhan Institute of Virology (WIV): The United States government has reason to believe that several researchers inside the WIV became sick in autumn 2019, before the first identified case of the outbreak, with symptoms consistent with both COVID-19 and common seasonal illnesses. This raises questions about the credibility of WIV senior researcher Shi Zhengli’s public claim that there was “zero infection” among the WIV’s staff and students of SARS-CoV-2 or SARS-related viruses.
  1. WIV Research on “RaTG13” and “gain of function”: Starting in at least 2016, WIV researchers studied RaTG13, the bat coronavirus identified by the WIV in January 2020 as its closest sample to SARS-CoV-2 (96.2% similar). Since the outbreak, the WIV has not been transparent nor consistent about its work with RaTG13 or other similar viruses, including possible “gain of function” experiments to enhance transmissibility or lethality.
  1. Secret WIV Links to Military Research: Despite the WIV presenting itself as a civilian institution, the WIV has collaborated on publications and secret projects with China’s military. The WIV has engaged in classified research, including laboratory animal experiments, on behalf of the Chinese military since at least 2017.

The COVID-19 pandemic was avoidable. Any responsible country would have invited world health investigators to Wuhan within days of an outbreak. China instead refused offers of help – including from the United States – and punished brave Chinese doctors, scientists, and journalists who tried to alert the world to the dangers of the virus. Beijing continues today to withhold vital information that scientists need to protect the world from this deadly virus, and the next one.

The United States reiterates the importance of unfettered access to virus samples, lab records and personnel, eyewitnesses, and whistleblowers to ensure the credibility of the WHO’s final report. Until the CCP allows a full and thorough accounting of what happened in Wuhan, it is only a matter of time until China births another pandemic and inflicts it on the Chinese people, and the world.

Fact Sheet: Activity at the Wuhan Institute of Virology

More from: Michael R. Pompeo, Secretary of State

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    The Justice Department today announced that it has reached a settlement, through a court-supervised settlement agreement, with the State of Michigan and the Michigan Department of Corrections (MDOC) to resolve a sex discrimination lawsuit brought by the United States of America.
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  • Operation Warp Speed: Accelerated COVID-19 Vaccine Development Status and Efforts to Address Manufacturing Challenges
    In U.S GAO News
    Operation Warp Speed (OWS)—a partnership between the Departments of Health and Human Services (HHS) and Defense (DOD)—aimed to help accelerate the development of a COVID-19 vaccine. GAO found that OWS and vaccine companies adopted several strategies to accelerate vaccine development and mitigate risk. For example, OWS selected vaccine candidates that use different mechanisms to stimulate an immune response (i.e., platform technologies; see figure). Vaccine companies also took steps, such as starting large-scale manufacturing during clinical trials and combining clinical trial phases or running them concurrently. Clinical trials gather data on safety and efficacy, with more participants in each successive phase (e.g., phase 3 has more participants than phase 2). Vaccine Platform Technologies Supported by Operation Warp Speed, as of January 2021 As of January 30, 2021, five of the six OWS vaccine candidates have entered phase 3 clinical trials, two of which—Moderna's and Pfizer/BioNTech's vaccines—have received an emergency use authorization (EUA) from the Food and Drug Administration (FDA). For vaccines that received EUA, additional data on vaccine effectiveness will be generated from further follow-up of participants in clinical trials already underway before the EUA was issued. Technology readiness. GAO's analysis of the OWS vaccine candidates' technology readiness levels (TRL)—an indicator of technology maturity— showed that COVID-19 vaccine development under OWS generally followed traditional practices, with some adaptations. FDA issued specific guidance that identified ways that vaccine development may be accelerated during the pandemic. Vaccine companies told GAO that the primary difference from a non-pandemic environment was the compressed timelines. To meet OWS timelines, some vaccine companies relied on data from other vaccines using the same platforms, where available, or conducted certain animal studies at the same time as clinical trials. However, as is done in a non-pandemic environment, all vaccine companies gathered initial safety and antibody response data with a small number of participants before proceeding into large-scale human studies (e.g., phase 3 clinical trials). The two EUAs issued in December 2020 were based on analyses of clinical trial participants and showed about 95 percent efficacy for each vaccine. These analyses included assessments of efficacy after individuals were given two doses of vaccine and after they were monitored for about 2 months for adverse events. Manufacturing. As of January 2021, five of the six OWS vaccine companies had started commercial scale manufacturing. OWS officials reported that as of January 31, 2021, companies had released 63.7 million doses—about 32 percent of the 200 million doses that, according to OWS, companies with EUAs have been contracted to provide by March 31, 2021. Vaccine companies face a number of challenges in scaling up manufacturing to produce hundreds of millions of doses under OWS's accelerated timelines. DOD and HHS are working with vaccine companies to help mitigate manufacturing challenges, including: Limited manufacturing capacity: A shortage of facilities with capacity to handle the vaccine manufacturing needs can lead to production bottlenecks. Vaccine companies are working in partnership with OWS to expand production capacity. For example, one vaccine company told GAO that HHS's Biomedical Advanced Research and Development Authority helped them identify an additional manufacturing partner to increase production. Additionally, the U.S. Army Corps of Engineers is overseeing construction projects to expand capacity at vaccine manufacturing facilities. Disruptions to manufacturing supply chains: Vaccine manufacturing supply chains have been strained by the global demand for certain goods and workforce disruptions caused by the global pandemic. For example, representatives from one facility manufacturing COVID-19 vaccines stated that they experienced challenges obtaining materials, including reagents and certain chemicals. They also said that due to global demand, they waited 4 to 12 weeks for items that before the pandemic were typically available for shipment within one week. Vaccine companies and DOD and HHS officials told GAO they have undertaken several efforts to address possible manufacturing disruptions and mitigate supply chain challenges. These efforts include federal assistance to (1) expedite procurement and delivery of critical manufacturing equipment, (2) develop a list of critical supplies that are common across the six OWS vaccine candidates, and (3) expedite the delivery of necessary equipment and goods coming into the United States. Additionally, DOD and HHS officials said that as of December 2020 they had placed prioritized ratings on 18 supply contracts for vaccine companies under the Defense Production Act, which allows federal agencies with delegated authority to require contractors to prioritize those contracts for supplies needed for vaccine production. Gaps in the available workforce: Hiring and training personnel with the specialized skills needed to run vaccine manufacturing processes can be challenging. OWS officials stated that they have worked with the Department of State to expedite visa approval for key technical personnel, including technicians and engineers to assist with installing, testing, and certifying critical equipment manufactured overseas. OWS officials also stated that they requested that 16 DOD personnel be detailed to serve as quality control staff at two vaccine manufacturing sites until the organizations can hire the required personnel. As of February 5, 2021, the U.S. had over 26 million cumulative reported cases of COVID-19 and about 449,020 reported deaths, according to the Centers for Disease Control and Prevention. The country also continues to experience serious economic repercussions, with the unemployment rate and number of unemployed in January 2021 at nearly twice their pre-pandemic levels in February 2020. In May 2020, OWS was launched and included a goal of producing 300 million doses of safe and effective COVID-19 vaccines with initial doses available by January 2021. Although FDA has authorized two vaccines for emergency use, OWS has not yet met its production goal. Such vaccines are crucial to mitigate the public health and economic impacts of the pandemic. GAO was asked to review OWS vaccine development efforts. This report examines: (1) the characteristics and status of the OWS vaccines, (2) how developmental processes have been adapted to meet OWS timelines, and (3) the challenges that companies have faced with scaling up manufacturing and the steps they are taking to address those challenges. GAO administered a questionnaire based on HHS's medical countermeasures TRL criteria to the six OWS vaccine companies to evaluate the COVID-19 vaccine development processes. GAO also collected and reviewed supporting documentation on vaccine development and conducted interviews with representatives from each of the companies on vaccine development and manufacturing. For more information, contact Karen L. Howard and Candice N. Wright at (202) 512-6888 or howardk@gao.gov or wrightc@gao.gov.
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  • Veterans Community Care Program: Improvements Needed to Help Ensure Timely Access to Care
    In U.S GAO News
    In a September 2020 report, GAO found that the Department of Veterans Affairs (VA) established an appointment scheduling process for its new Veterans Community Care Program (VCCP) but did not specify allowable wait times for some key steps in the process. Further, GAO found that VA had not established an overall wait-time performance measure—that is, the maximum amount of time it should take for veterans to receive care from community providers. In 2013, GAO recommended that VA establish a wait-time measure under a prior VA community care program, and in 2018 again recommended that VA establish an achievable wait-time goal to receive care under the VCCP. VA has not implemented these recommendations. Potential Allowable Wait Time to Obtain Care through the Veterans Community Care Program Note: This figure illustrates potential allowable wait times in calendar days for eligible veterans who are referred to the Veterans Community Care Program through routine referrals (not urgent), and have VA medical center staff—Referral Coordination Team (RCT) and community care staff (CC staff)—schedule the appointments on their behalf. Given VA's lack of action over the prior 7 years in implementing wait-time measures for various community care programs, GAO believes that Congressional action is warranted requiring VA to establish such an overall measure for the VCCP. This should help to achieve timely health care for veterans. GAO found additional VCCP challenges needing VA action: (1) VA uses metrics that are remnants from the previous community care program and inconsistent with the time frames established in the VCCP scheduling process. (2) Few community providers have signed up to use the software VA intends for VA medical center (VAMC) staff and community providers to use to electronically share referral information with each other. (3) Select VAMCs faced challenges scheduling appointments in a timely manner and most did not have the full amount of community care staff VA's staffing tool recommended. In June 2019, VA implemented its new community care program, the VCCP, as required by the VA MISSION Act of 2018. This new program replaced or consolidated prior community care programs. Under the VCCP, VAMC staff are responsible for community care appointment scheduling. This statement summarizes GAO's September 2020 report. It describes for the VCCP: (1) the appointment scheduling process that VA established for veterans, (2) the metrics VA used to monitor the timeliness of appointment scheduling, (3) VA's efforts to prepare VAMC staff for appointment scheduling, and (4) VA's efforts to determine VAMC staffing needs. In performing that work, GAO reviewed VA documentation, such as guidance, referral timeliness data, and VAMC community care staffing data; conducted site visits to five VAMCs; and interviewed VA and VAMC officials. In its September 2020 report, GAO recommended that Congress consider requiring VA to establish an overall wait-time measure for the VCCP. GAO also made three recommendations to VA, including that it align its monitoring metrics with the VCCP appointment scheduling process. VA did not concur with this recommendation, but concurred with the other two. GAO maintains that all recommendations are warranted. For more information, contact Sharon M. Silas at (202) 512-7114 or silass@gao.gov.
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  • Small Business Administration: COVID-19 Loans Lack Controls and Are Susceptible to Fraud
    In U.S GAO News
    In April 2020, the Small Business Administration (SBA) moved quickly to implement the Paycheck Protection Program (PPP), which provides loans that are forgivable under certain circumstances to small businesses affected by COVID-19. Given the immediate need for these loans, SBA worked to streamline the program so that lenders could begin distributing these funds as soon as possible. For example, lenders were permitted to rely on borrowers' self-certifications for eligibility and use of loan proceeds. As a result, there may be significant risk that some fraudulent or inflated applications were approved. Since May 2020, the Department of Justice has publicly announced charges in more than 50 fraud-related cases associated with PPP funds. In April 2020, SBA announced it would review all loans of more than $2 million to confirm borrower eligibility, and SBA officials subsequently stated that they would review selected loans of less than $2 million to determine, for example, whether the borrower is entitled to loan forgiveness. However, SBA did not provide details on how it would conduct either of these reviews. As of September 2020, SBA reported it was working with the Department of the Treasury and contractors to finalize the plans for the reviews. Because SBA had limited time to implement safeguards up front for loan approval, GAO believes that planning and oversight by SBA to address risks in the PPP program is crucial moving forward. SBA's efforts to expedite processing of Economic Injury Disaster Loans (EIDL)—such as the reliance on self-certification—may have contributed to increased fraud risk in that program as well. In July 2020, SBA's Office of Inspector General (OIG) reported indicators of widespread potential fraud—including thousands of fraud complaints—and found deficiencies with SBA's internal controls. In response, SBA maintained that its internal controls for EIDL were robust, including checks to identify duplicate applications and verify account information, and that it had provided banks with additional antifraud guidance. The Department of Justice, in conjunction with other federal agencies, also has taken actions to address potential fraud. Since May 2020, the department has announced fraud investigations related to the EIDL program and charges against recipients related to EIDL fraud. SBA has made or guaranteed more than 14.5 million loans and grants through PPP and EIDL, providing about $729 billion to help small businesses adversely affected by COVID-19. However, the speed with which SBA implemented the programs may have increased their susceptibility to fraud. This testimony discusses fraud risks associated with SBA's PPP and EIDL programs. It is based largely on GAO's reports in June 2020 (GAO-20-625) and September 2020 (GAO-20-701) that addressed the federal response, including by SBA, to the economic downturn caused by COVID-19. For those reports, GAO reviewed SBA documentation and interviewed officials from SBA, the Department of the Treasury, and associations that represent lenders and small businesses. GAO also met with officials from the SBA OIG and reviewed OIG reports. In its June 2020 report, GAO recommended that SBA develop and implement plans to identify and respond to risks in PPP to ensure program integrity, achieve program effectiveness, and address potential fraud. SBA neither agreed nor disagreed, but GAO believes implementation of this recommendation is essential. For more information, contact William B. Shear at (202) 512-4325 or shearw@gao.gov.
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  • Aviation Cybersecurity: FAA Should Fully Implement Key Practices to Strengthen Its Oversight of Avionics Risks
    In U.S GAO News
    Modern airplanes are equipped with networks and systems that share data with the pilots, passengers, maintenance crews, other aircraft, and air-traffic controllers in ways that were not previously feasible (see fig. 1). As a result, if avionics systems are not properly protected, they could be at risk of a variety of potential cyberattacks. Vulnerabilities could occur due to (1) not applying modifications (patches) to commercial software, (2) insecure supply chains, (3) malicious software uploads, (4) outdated systems on legacy airplanes, and (5) flight data spoofing. To date, extensive cybersecurity controls have been implemented and there have not been any reports of successful cyberattacks on an airplane's avionics systems. However, the increasing connections between airplanes and other systems, combined with the evolving cyber threat landscape, could lead to increasing risks for future flight safety. Figure 1: Key Systems Connections to Commercial Airplanes The Federal Aviation Administration (FAA) has established a process for the certification and oversight of all US commercial airplanes, including the operation of commercial air carriers (see fig. 2). While FAA recognizes avionics cybersecurity as a potential safety issue for modern commercial airplanes, it has not fully implemented key practices that are necessary to carry out a risk-based cybersecurity oversight program. Specifically, FAA has not (1) assessed its oversight program to determine the priority of avionics cybersecurity risks, (2) developed an avionics cybersecurity training program, (3) issued guidance for independent cybersecurity testing, or (4) included periodic testing as part of its monitoring process. Until FAA strengthens its oversight program, based on assessed risks, it may not be able to ensure it is providing sufficient oversight to guard against evolving cybersecurity risks facing avionics systems in commercial airplanes. Figure 2: Federal Aviation Administration's Certification Process for Commercial Transport Airplanes GAO has previously identified key practices for interagency collaboration that can be used to assess interagency coordination. FAA coordinates with other federal agencies, such as the Departments of Defense (DOD) and Homeland Security (DHS), and with industry to address aviation cybersecurity issues. For example, FAA co-chairs the Aviation Cyber Initiative, a tri-agency forum with DOD and DHS to address cyber risks across the aviation ecosystem. However, FAA's internal coordination activities do not fully reflect GAO's key collaboration practices. FAA has not established a tracking mechanism for monitoring progress on cybersecurity issues that are raised in coordination meetings, and its oversight coordination activities are not supported by dedicated resources within the agency's budget. Until FAA establishes a tracking mechanism for cybersecurity issues, it may be unable to ensure that all issues are appropriately addressed and resolved. Further, until it conducts an avionics cybersecurity risk assessment, it will not be able to effectively prioritize and dedicate resources to ensure that avionics cybersecurity risks are addressed in its oversight program. Avionics systems, which provide weather information, positioning data, and communications, are critical to the safe operation of an airplane. FAA is responsible for overseeing the safety of commercial aviation, including avionics systems. The growing connectivity between airplanes and these systems may present increasing opportunities for cyberattacks on commercial airplanes. GAO was asked to review the FAA's oversight of avionics cybersecurity issues. The objectives of this review were to (1) describe key cybersecurity risks to avionics systems and their potential effects, (2) determine the extent to which FAA oversees the implementation of cybersecurity controls that address identified risks in avionics systems, and (3) assess the extent to which FAA coordinates internally and with other government and industry entities to identify and address cybersecurity risks to avionics systems. To do so, GAO reviewed information on key cybersecurity risks to avionics systems, as reported by major industry representatives as well as key elements of an effective oversight program, and compared FAA's process for overseeing the implementation of cybersecurity controls in avionics systems with these program elements. GAO also reviewed agency documentation and interviewed agency and industry representatives to assess FAA's coordination efforts to address the identified risks. GAO is making six recommendations to FAA to strengthen its avionics cybersecurity oversight program: GAO recommends that FAA conduct a cybersecurity risk assessment of avionics systems cybersecurity within its oversight program to identify the relative priority of avionics cybersecurity risks compared to other safety concerns and develop a plan to address those risks. Based on the assessment of avionics cybersecurity risks, GAO recommends that FAA identify staffing and training needs for agency inspectors specific to avionics cybersecurity, and develop and implement appropriate training to address identified needs. develop and implement guidance for avionics cybersecurity testing of new airplane designs that includes independent testing. review and consider revising its policies and procedures for monitoring the effectiveness of avionics cybersecurity controls in the deployed fleet to include developing procedures for safely conducting independent testing. ensure that avionics cybersecurity issues are appropriately tracked and resolved when coordinating among internal stakeholders. review and consider the extent to which oversight resources should be committed to avionics cybersecurity. FAA concurred with five out of six GAO recommendations. FAA did not concur with the recommendation to consider revising its policies and procedures for periodic independent testing. GAO clarified this recommendation to emphasize that FAA safely conduct such testing as part of its ongoing monitoring of airplane safety. For more information, contact Nick Marinos at (202) 512-9342 or MarinosN@gao.gov, or Heather Krause at (202) 512-2834 or KrauseH@gao.gov.
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  • COVID-19: Urgent Actions Needed to Better Ensure an Effective Federal Response
    In U.S GAO News
    The COVID-19 pandemic has resulted in catastrophic loss of life and substantial damage to the global economy, stability, and security. According to federal data, the U.S. had an average of 116,000 new COVID-19 cases per day from November 1 through November 12, 2020. Between January 2020 and October 2020, at least 237,000 more deaths occurred from all causes, including COVID-19, than would normally be expected, according to data from the Centers for Disease Control and Prevention (CDC). Further, while the economy has improved since July 2020, many people remain unemployed, including both those temporarily laid off and those who have permanently lost their job (see figure). Also, more households have become seriously delinquent on mortgage payments during the pandemic. In addition, GAO’s review of academic studies suggests the pandemic will likely remain a significant obstacle to more robust economic activity. Number of Unemployed Workers Permanently Losing Jobs and on Temporary Layoff, January 2019 through October 2020 In response to the pandemic and its effects, Congress and the administration have taken a series of actions to protect the health and well-being of Americans. However, as the end of 2020 approaches, urgent actions are needed to help ensure an effective federal response on a range of public health and economic issues. Medical Supplies While the Department of Health and Human Services (HHS) and the Federal Emergency Management Agency (FEMA) have made numerous efforts to mitigate supply shortages and expand the medical supply chain, shortages of certain supplies persist. In September 2020, GAO reported that ongoing constraints with the availability of certain types of personal protective equipment (PPE) and testing supplies remain due to a supply chain with limited domestic production and high global demand. In October 2020, GAO surveyed public health and emergency management officials from all states, the District of Columbia, and U.S. territories (hereafter states) and found the following: Testing supplies. 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 (see figure). State-Reported Testing Supply Shortages, as of October 2020   GAO surveyed officials in the 50 states; Washington, D.C.; and the five U.S. territories and received responses from 47 of the 56 locations, representing 41 states; Washington, D.C.; and all five territories. Not all states responded to every question. PPE. The majority of states that responded were mainly able to fulfill requests for supplies from organizations and entities within their states. However, availability constraints continue with certain PPE, such as nitrile gloves. Supplies for future vaccine needs. About one-third of states that responded stated that they were “greatly” or “completely” concerned about having sufficient vaccine-related supplies to administer COVID-19 vaccines. An additional 21 states indicated that they were moderately concerned. In September 2020, GAO recommended that HHS, in coordination with FEMA, should 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; and devise interim solutions, such as systems and guidance and dissemination of best practices, to help states enhance their ability to track the status of supply requests and plan for supply needs for the remainder of the pandemic response. HHS and the Department of Homeland Security disagreed with these recommendations, noting, among other things, the work that they had done to manage the medical supply chain and increase supply availability. In November 2020, HHS repeated its disagreement with GAO’s recommendations and noted its efforts to meet the needs of states. In light of the surge in COVID-19 cases, along with reported shortages, including GAO’s nationwide survey findings, GAO underscores the critical imperative for HHS and FEMA to implement GAO’s September 2020 recommendations. Vaccines and Therapeutics In a recent GAO report (GAO-21-207), GAO found that there has been significant federal investment to accelerate vaccine and therapeutic development, such as through Operation Warp Speed, a partnership between the Department of Defense and HHS that aims to accelerate the development, manufacturing, and distribution of COVID-19 vaccines and therapeutics. Separately, Emergency Use Authorizations (EUA), which allow for the emergency use of medical products without Food and Drug Administration (FDA) approval or licensure provided certain statutory criteria are met, have also been used for therapeutics. As of November 9, 2020, FDA had made four therapeutics available to treat COVID-19 through EUAs. In that report, GAO recommended that FDA identify waysto uniformly discloseinformation from its scientific review of safety and effectiveness data when issuing EUAs for therapeutics and vaccines. By doing so, FDA could help improve the transparency of, and ensure public trust in, its EUA decisions. HHS neither agreed nor disagreed with the recommendation, but said it shared GAO’s goal of transparency. COVID-19 Testing Guidance HHS and its component agencies have taken several key actions to document a federal COVID-19 testing strategy and provide testing-related agency guidance. However, this guidance has not always been transparent, raising the risk of confusion and eroding trust in government. In particular, while it is expected that guidance will change as new information about the novel virus evolves, frequent changes to general CDC testing guidelines have not always been communicated with a scientific explanation. GAO recommends that HHS ensure that CDC clearly discloses the scientific rationale for any change to testing guidelines at the time the changeis made. HHS concurred with this recommendation. Types of COVID-19 Testing Approaches Nursing Home Care In September 2020, the Coronavirus Commission on Safety and Quality in Nursing Homes (established by the Centers for Medicare & Medicaid Services (CMS) in June 2020) made 27 recommendations to CMS on topics such as testing, PPE, and visitation. CMS released a response to the commission that broadly outlined the actions it has taken to date, but it has not fully addressed the commission’s recommendations or provided an implementation plan to track and report progress toward implementing them. While CMS is not obligated to implement all of the commission’s recommendations, the agency has not indicated any areas where it does not plan to take action. GAO recommends that CMS quickly develop a plan that further details how it intends to respond to and implement, as appropriate, the commission’s recommendations. HHS neither agreed nor disagreed with this recommendation and said it would refer to and act upon the commission’s recommendations, as appropriate. In addition, the Department of Veterans Affairs (VA) partners with state governments to provide nursing home care to more than 20,000 veterans in over 150 state veterans homes. In March 2020, VA instructed its contractor to stop in-person inspections due to concerns about COVID-19. As of September 2020, these inspections had not resumed, leaving veterans at risk of receiving poor quality care. Additionally, VA does not collect timely data on the number of COVID-19 cases and deaths occurring at each state veterans home, hindering its ability to monitor and take steps to mitigate the spread of COVID-19 in these homes. GAO recommends that VA (1) develop a plan to resume inspections of state veterans homes, which may include using in-person, a mix of virtual and in-person, or fully virtual inspections, and (2) collect timely data on COVID-19 cases and deaths in each state veterans home. VA concurred with both recommendations. Economic Impact Payments The CARES Act included economic impact payments (EIP) for eligible individuals to address financial stress due to the pandemic. As of September 30, 2020, the Department of the Treasury (Treasury) and the Internal Revenue Service (IRS) had disbursed over 165.8 million payments to individuals, totaling $274.7 billion. According to IRS data, more than 26 million non-filers—individuals who do not normally file a tax return and may be hard to reach—received a payment (see figure). However, everyone that was supposed to receive a payment was not reached. Starting in September 2020, IRS sent notices to nearly 9 million individuals who had not yet received an EIP. Number of Filers and Non-Filers Issued an Economic Impact Payment, as of September 30, 2020 Treasury and IRS officials did not plan to track and analyze the outcomes of their EIP notice mailing effort until 2021. The lack of timely analysis deprives Treasury and IRS of data they could use to assess the effectiveness of their notice strategy and redirect resources as needed to other outreach and communication efforts. GAO recommends that Treasury, in coordination with IRS, should begin tracking and publicly reporting the number of individuals who were mailed an EIP notification letter and filed for and received an EIP, and use that information to inform ongoing outreach and communications efforts. Treasury agreed with this recommendation. Unemployment Insurance The CARES Act created three federally funded temporary programs for unemployment insurance (UI) that expanded benefit eligibility and enhanced benefits. In its weekly news releases, the Department of Labor (DOL) publishes the number of weeks of unemployment benefits claimed by individuals in each state during the period and reports the total count as the number of people claiming benefits nationwide. DOL officials told GAO that they have traditionally used this number as a proxy for the number of individuals claiming benefits because they were closely related. However, the number of claims has not been an accurate estimate of the number of individuals claiming benefits during the pandemic because of backlogs in processing a historic volume of claims, among other data issues. Without an accurate accounting of the number of individuals who are relying on these benefits in as close to real time as possible, policymakers may be challenged to respond to the crisis at hand. GAO recommends that DOL (1) 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, and (2) pursue options to report the actual number of distinct individuals claiming benefits, such as by collecting these already available data from states. DOL agreed with the recommendation to revise its weekly news releases, and partially agreed with the recommendation to pursue options to report the actual number of distinct individuals claiming benefits. Tax Relief for Businesses To provide liquidity to businesses during the pandemic, the CARES Act included tax measures to help businesses receive cash refunds or other reductions to tax obligations. Some taxpayers need to file an amended income tax return to take advantage of these provisions; at the same time, IRS faces an increase in mail and paper processing delays due to the pandemic, which may delay the timely processing of this paperwork and issuance of these refunds. GAO recommends that IRS update its form instructions to include information on its electronic filing capability for tax year 2019. IRS agreed with this recommendation. Program Integrity Although the extent and significance of improper payments associated with COVID-19 relief funds have not yet been determined, the impact of these improper payments, including those that are the result of fraud, could be substantial. For example, numerous individuals are facing federal charges related to attempting to defraud the Paycheck Protection Program (PPP), UI program, or other federal programs, and many more investigations are underway. To address the risk of improper payments due to fraud and other causes, GAO previously recommended the following: The Small Business Administration (SBA) should develop and implement plans to identify and respond to risks in the PPP to ensure program integrity, achieve program effectiveness, and address potential fraud. The Office of Management and Budget (OMB), in consultation with Treasury, should issue timely guidance for auditing new and existing COVID-19-related programs, including Coronavirus Relief Fund payments, as soon as possible. Audits of entities that receive federal funds are critical to the federal government’s ability to help safeguard those funds.Also, Congress should amend the Social Security Act to explicitly allow the Social Security Administration to share its full death data with Treasury for data matching to prevent payments to ineligible individuals. GAO maintains that implementing these recommendations fully is critically important in order to protect federal funds from improper payments resulting from fraud and other risks. In this report, GAO also identifies new concerns about the timely reporting of improper payments for COVID-19 programs. The COVID-19 relief laws appropriated over a trillion dollars that may be spent through newly established programs to fund response and recovery efforts, such as SBA’s PPP. However, unlike the supplemental appropriations acts that provided for disaster relief related to the 2017 hurricanes and California wildfires, the COVID-19 relief laws did not require agencies to deem programs receiving these relief funds that expend more than a threshold amount as "susceptible to significant improper payments." In addition, based on OMB guidance, improper payment estimates associated with new COVID-19 programs established in March 2020 may not be reported until November 2022, in some instances. GAO is making two recommendations: OMB should develop and issueguidance directingagencies to include COVID-19 relief funding with associated key risks, such as changes to existing program eligibility rules, as part of their improper payment estimation methodologies, especially for existing programs that received COVID-19 relief funding. SBA should expeditiously estimate improper payments and report estimates and error rates for PPP due to concerns about the possibility that improper payments, including those resulting from fraudulent activity, could be widespread. GAO is also suggesting that Congress consider, in any future legislation appropriating COVID-19 relief funds, designating all executive agency programs and activities making more than $100 million in payments from COVID-19 relief funds as “susceptible to significant improper payments.” Aviation Assistance and Preparedness GAO identified concerns about efforts to monitor CARES Act financial assistance to the aviation sector. Treasury’s Payroll Support Program (PSP) provides $32 billion in payroll support payments and loans to help the aviation industry retain its employees. While recipients have begun submitting required compliance reports, Treasury has not yet finalized a monitoring system to identify and respond to the risk of noncompliance with PSP agreement terms, potentially hindering its ability to detect program misuse in a timely manner. GAO is recommending that Treasury finish developing and implement acompliance monitoringplan that identifies and responds to risks in the PSP. Treasury neither agreed nor disagreed with this recommendation, but committed to reviewing additional measures that may further enhance its compliance monitoring and ensure that PSP funds are used as intended. In June 2020, GAO suggested that Congress take legislative action to require the Secretary of Transportation to work with relevant agencies, such as HHS, the Department of Homeland Security, and other stakeholders, to develop a national aviation-preparedness plan to limit the spread of communicable diseasethreats and minimize traveland trade impacts. GAO originally made this recommendation to the Department of Transportation in December 2015. GAO urges Congress to take swift action to require such a plan, without which the U.S. will not be as prepared to minimize and quickly respond to ongoing and future communicable disease events. As of November 12, 2020, the U.S. had over 10.3 million cumulative reported cases of COVID-19 and about 224,000 reported deaths, according to federal agencies. The country also continues to experience serious economic repercussions. Four relief laws, including the CARES Act, were enacted as of November 2020 to provide appropriations to address the public health and economic threats posed by COVID-19. As of September 30, 2020, of the $2.6 trillion appropriated by these acts, the federal government had obligated a total of $1.8 trillion and expended $1.6 trillion of the COVID-19 relief funds, as reported by federal agencies. The CARES Act included 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. GAO also sent a survey to public health and emergency management officials in the 50 states, Washington, D.C., and the five U.S. territories regarding medical supplies. GAO is making 11 new recommendations for agencies that are detailed in this Highlights and in the report. GAO is also raising one matter for congressional consideration. For more information, contact A. Nicole Clowers at (202)512-7114 or clowersa@gao.gov.
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