https://www.gao.gov Mon, 26 Oct 2020 16:36:59 -0400 GAO /images/gao_logo_rss.gif https://www.gao.gov/ Feed provided by GAO. Click to visit. https://www.gao.gov/products/GAO-21-41 What GAO Found Literature GAO reviewed indicated that private insurance payments for anesthesia services on average were more than 3-1/2 times those of Medicare payments. This payment difference increased from what GAO reported in 2007—average private insurance payments for certain anesthesia services in 2004 were about 3 times those of Medicare. While Medicare rates for anesthesia services are set by the Centers for Medicare & Medicaid Services (CMS), private insurance rates are set through negotiations between providers and private insurers. GAO identified three recent studies with analyses of private insurance and Medicare payments for anesthesia services: Researchers from Yale University calculated that private insurance payments were 3.67 times Medicare payments, on average, for services provided by anesthesiologists for one large private insurer in 2015 operating across all 50 states and the District of Columbia. The Health Care Cost Institute calculated that in 2017 private insurance payments ranged from 2 to 7 times Medicare payments, on average, across six common services provided by anesthesiologists in 33 states. Wide state-to-state variation within specific services was reported. The American Society of Anesthesiologists reported that private insurance payments were 3.46 times Medicare payments, on average, based on a survey of its members in 2019. According to studies GAO reviewed and stakeholders GAO interviewed, market factors likely enhanced anesthesia providers' negotiating position and allowed them to secure higher private payments. For example, several studies and stakeholders cited market concentration as a key factor that increased private payments for anesthesia services. In a market with high provider concentration—or relatively few providers in a given market—there is little competition between providers, enabling the providers within that market to negotiate for higher payments from private insurers. Studies also indicated that specialists, including anesthesia providers, could negotiate higher in-network payment rates because they were able to leave an insurer's network with little risk of losing patients or revenue. In addition, when anesthesia providers are not a part of a private insurer's network, they are typically able to bill for a higher amount than the insurer would pay for an in-network provider, known as out-of-network billing. This dynamic decreases providers' incentives to participate in insurer networks because it creates an attractive alternative to network participation. GAO's interviews with stakeholders, literature review, and review of agency data generally did not indicate that the supply of anesthesia providers was insufficient for Medicare beneficiaries. CMS data indicate that the number of active anesthesia providers per 100,000 Medicare beneficiaries increased from 2010 through 2018 and that a very small number of anesthesia providers opted out of the Medicare program. Furthermore, researchers and stakeholders GAO interviewed were not aware of any issues with access to anesthesia services for Medicare beneficiaries, including those in traditionally underserved rural areas. Why GAO Did This Study In 2018, Medicare paid over $2 billion for anesthesia services, such as general anesthesia administered to beneficiaries undergoing surgical or other invasive procedures. The joint explanatory statement for the Further Consolidated Appropriations Act, 2020 included a provision for GAO to update its 2007 report and examine how differences in payment rates for anesthesia services have changed since that time. In 2007, GAO reported that Medicare payments in 2004 for certain anesthesia services provided by anesthesiologists were on average 67 percent lower than private insurance payments in certain geographic areas—indicating that private payments were about 3 times more than Medicare payments at that time. This report describes what is known about (1) recent trends in differences between Medicare and private payments for anesthesia services, and (2) the sufficiency of the supply of anesthesia providers for Medicare beneficiaries. GAO reviewed literature and available published data on payment differences for anesthesia services, published in the United States since 2010. GAO also reviewed data from CMS on the number of anesthesia providers from 2010, 2018, and 2020. GAO also interviewed a nongeneralizable selection of three research groups, two beneficiary advocacy groups, and five stakeholder groups, including those representing anesthesiologists, nurse anesthetists, and hospitals, to obtain their perspectives on these issues. The Department of Health and Human Services provided no comments on this report. For more information, contact Jessica Farb at (202) 512-7114 or farbj@gao.gov. Mon, 26 Oct 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-21-72 What GAO Found In response to the Department of Labor's Home Care Rule—which extended Fair Labor Standards Act (FLSA) minimum wage and overtime protections to more home care workers—some states made changes in their Medicaid programs, according to studies and GAO interviews with stakeholders and selected state officials. Many stakeholders said the rule led some states to limit home care workers' hours in their Medicaid programs to avoid overtime costs. For example, in Oregon, newly hired home care workers provided through Medicaid were generally limited to 40 hours per week, according to state documentation. Some states also budgeted additional funds for overtime pay. In addition, according to a few stakeholder groups, some states changed service delivery in their Medicaid programs, for example, by discontinuing services such as live-in care. In contrast, several stakeholders said some states did not make any major changes to their Medicaid programs' home care services. Provider agencies, workers, and consumers experienced changes after the Home Care Rule took effect. Specifically, some provider agencies restricted workers' hours to limit overtime costs, though this can result in the need to hire more workers, leading to increased costs of recruiting, training, and scheduling, according to several stakeholders. GAO's analysis of national survey data found that home care workers, when compared to occupations with similar education and training requirements, were more likely to work full-time but did not earn significantly higher earnings following the Home Care Rule (see figure). Many stakeholders GAO spoke with described ongoing challenges consumers face in obtaining home care services, such as difficulty finding workers to hire. Estimated Median Weekly Earnings of Employed Workers, 2010 through 2019 Note: The margins of error at the 95 percent confidence level are within plus or minus 7.2 percent of the estimate itself. Why GAO Did This Study Employment in home care is projected to grow nearly 40 percent over the next decade to meet demand from an increasing population of older adults and people with disabilities. Home care workers help those who need assistance with activities of daily living such as dressing, eating, or bathing. State Medicaid programs may allow home care for eligible individuals as an alternative to institutional care. The Department of Labor's (DOL) Home Care Rule, which went into effect in 2015, extended FLSA protections to more home care workers. GAO was asked to review the implementation and effects of the Home Care Rule. This report examines what is known about (1) changes states made to their Medicaid programs in response to the Home Care Rule; and (2) the Home Care Rule's effect on home care provider agencies, workers, and consumers. To address these objectives, GAO analyzed 2010 through 2019 national survey data on workers' hours and wages; interviewed stakeholders from 15 organizations that represent the different groups affected, DOL officials, and home care program officials from three states selected based on variation in their Medicaid programs and minimum wage levels; and reviewed studies on state strategies to implement the Home Care Rule. For more information, contact Melissa Emrey-Arras at (617) 788-0534 or emreyarrasm@gao.gov. Mon, 19 Oct 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-21-69 What GAO Found The Department of Veterans Affairs' (VA) Veterans Health Administration (VHA) analyzes national-level data by birth sex to assess health outcomes for women veterans. For example, it analyzes frequency data to identify their most common health conditions. However, VHA is limited in its assessment of health outcomes for the lesbian, gay, bisexual, and transgender (LGBT) veteran population because it does not consistently collect sexual orientation or self-identified gender identity (SIGI) data. VHA officials stated that providers may record veterans' sexual orientation—which can be used to identify lesbian, gay, and bisexual veterans—in non-standardized clinical notes in electronic health records. However, without a standardized field, providers may not be consistently collecting these data, and VHA does not know the total number of these veterans in its system. VHA officials recognize the importance of consistently collecting these data, but have yet to develop and implement a field for doing so. VHA collects SIGI data—which can be used in part to identify transgender veterans—in enrollment, administrative, and electronic health record systems. Although VHA has worked to improve the collection of these data, GAO found inconsistencies in how VHA records SIGI and, according to VA, 89 percent of veterans' records lack SIGI information. VHA added a field to collect this information in the administrative system; however, these data are not linked to electronic health records. As such, VHA providers cannot see the data during clinical visits when determining the appropriate services for transgender veterans, such as screening certain transgender men for breast and cervical cancers, as required by VHA policy. VHA's plan to link SIGI data across both systems has been postponed several times, and the data remain unlinked. VHA Sexual Orientation and Self-Identified Gender Identity (SIGI) Data Collection Limitations, Fiscal Year 2020 Until VHA can more consistently collect and analyze sexual orientation and SIGI data for the veteran population served, it will have a limited understanding of the health care needs of LGBT veterans, including any disparities they may face. Why GAO Did This Study VHA provides care to a diverse population of veterans, including women and LGBT veterans. These veterans may experience differences in health outcomes that are closely linked with social or economic disadvantage, and VA considers it important to analyze the services they receive as well as their health outcomes to improve health equity. House Report 115-188 included a provision for GAO to review VA's data collection and reporting procedures for information on veterans' gender and sexual orientation. This report describes how VHA assesses health outcomes for women veterans and examines the extent to which VHA assesses health outcomes for LGBT veterans. GAO reviewed VHA directives and VHA's Health Equity Action Plan. GAO interviewed officials from VHA's Women's Health Services and LGBT Health Program, VHA researchers who focus on women and LGBT veterans, and representatives from other health care systems with experience collecting gender and sexual orientation information. What GAO Recommends GAO is making four recommendations to VA to consistently collect sexual orientation and SIGI data, and analyze these data to assess health outcomes for LGBT veterans. VA concurred with GAO's recommendations and identified actions it is taking to address them. For more information, contact Debra A. Draper at (202) 512-7114 or draperd@gao.gov. Mon, 19 Oct 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-21-22 What GAO Found Physicians GAO interviewed generally found prescription drug monitoring programs (PDMPs) to be useful in preventing drug misuse and potentially dangerous drug prescribing. PDMPs are state-operated electronic databases that track prescriptions patients receive for opioids or other medications that are at risk of being misused. Most of the 31 physicians GAO interviewed said PDMP information helped them identify potential doctor shopping (when patients inappropriately seek medications from multiple physicians) and avoid potentially dangerous drug prescribing (such as dangerous drug combinations or high cumulative amounts). About half of the physicians also found PDMPs useful for providing overall patient care. Some of these physicians said their PDMPs provided more comprehensive information on patients' prescription histories than was available in patients' electronic health records (EHR). Physicians described how they could use PDMP information to determine which medications a patient had received and to discuss with patients the risks or benefits of treatment options. Physicians identified the lack of integration of PDMP information into EHR systems as a key challenge for most effectively using PDMPs for patient care. With integration, physicians can access PDMP information within EHR systems they use, rather than accessing the PDMP separately. Most of the physicians GAO interviewed said their PDMP was not integrated with their EHR system and accessing the PDMP separately was a challenge. Some stakeholders knowledgeable about PDMPs said the extra time it takes to search the PDMP without integration could place a significant time burden on some physicians, such as those working in an emergency department in which time may be limited. Steps Reported by Physicians and Prescription Drug Monitoring Program (PDMP) Officials to Search PDMPs Using Non-integrated and Integrated Approaches State and federal agencies are taking steps to improve PDMP integration with EHR systems. For example, state officials from nine of the 10 states in GAO's review described efforts to facilitate integration of PDMP information into EHRs. Federal agencies that support PDMPs, including the Department of Justice (DOJ) and Department of Health and Human Services (HHS), have also made funding and technical support available to states to help improve integration. Why GAO Did This Study Prescription medications—particularly when misused or overprescribed—can contribute to dangerous drug interactions, substance use disorder, overdoses, and deaths. The federal government has identified PDMPs as key tools to help ensure the safe and appropriate prescribing of opioids and other controlled substances. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act includes a provision for GAO to study the operation of PDMPs. In this report, GAO describes (1) physicians' views on the usefulness of PDMPs when making patient care decisions; and (2) challenges to using PDMPs when making patient care decisions, as well as state and federal efforts to address these challenges. GAO interviewed 31 physicians in 10 selected states and PDMP officials in nine of the 10 states. The selected states vary geographically and by other factors such as overdose death rates. GAO selected physicians from medical specialties that prescribe opioids. GAO also conducted interviews with relevant national organizations, organizations representing pharmacists, and officials from federal agencies that support PDMPs, and reviewed relevant federal strategy documents and grant announcements. GAO received technical comments on a draft of this report from HHS, DOJ, and the Office of National Drug Control Policy, and incorporated them as appropriate. For more information, contact Alyssa M. Hundrup, (202) 512-7114 or HundrupA@gao.gov. Thu, 01 Oct 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-487 What GAO Found The Department of Veterans Affairs' (VA) Medical-Surgical Prime Vendor-Next Generation (MSPV-NG) program is intended to provide an efficient, cost-effective way for its 170 medical centers to order supplies. But only 11 percent of these centers met VA's target of using the MSPV-NG formulary—the list of supplies offered—for 90 percent of medical supply purchases. GAO met with 12 medical centers and found contributing factors, such as a manual formulary management system, that resulted in ordering errors and delivery delays. VA's planned MSPV 2.0 program is designed to fix some, but not all, issues. The manual formulary management system, among others, will remain unaddressed. In addition, GAO found that supplies shipped directly from manufacturers instead of local warehouses—known as drop shipments—often result in late deliveries (see figure). About a third of supplies on the MSPV-NG formulary are drop-shipped, and this issue will continue under MSPV 2.0, as reducing drop-shipped items is not part of VA's planned changes under the new program. Out-of-Stock Notices Observed in VA Medical Center Supply Storage Areas VA is also piloting the use of the Defense Logistics Agency's (DLA) MSPV program at three VA medical centers to determine whether it provides a more effective means of obtaining required medical and surgical supplies than MSPV 2.0. VA started the pilot at one location but delayed rollout to the other locations by almost a year, to July and August 2020, because of technology integration challenges. VA has not established comprehensive metrics or criteria from which to determine the pilot's success or whether the pilot could be scalable to medical centers VA-wide. Without these metrics, VA risks not having an effective methodology for evaluating pilot success. In September 2020, after GAO sent a draft of this report to VA for comment, senior VA officials stated VA has decided to implement DLA MSPV VA-wide in place of MSPV 2.0, and will continue to implement MSPV 2.0 in the interim. This planned approach makes assessing the outcomes of the implementation at the initial sites all the more important, to help VA understand potential challenges. Why GAO Did This Study VA is developing the next iteration of its prime vendor program, MSPV 2.0, to meet the healthcare needs of about 9 million veterans. GAO's prior work found that VA medical centers' use of the MSPV formulary fell below targets in VA's prior iteration of the program and that VA lacked an overarching medical supply program strategy. In 2019, GAO elevated VA Acquisition Management to its High Risk List, in part due to its lack of an effective strategy for procuring medical supplies. GAO was asked to review VA's MSPV program. This report assesses, among other things, VA medical centers' use of MSPV-NG and whether MSPV 2.0 will mitigate current program issues, as well as whether VA has measures for DLA MSPV pilot success and scalability. GAO analyzed VA and DLA documents and data, conducted site visits to 12 VA medical centers with higher medical supply spending, and interviewed VA and DLA officials within various levels at the agencies. GAO completed most of this review prior to March 2020, and, thus, did not address the COVID-19 pandemic. What GAO Recommends GAO is making eight recommendations to VA, including that it examine opportunities to automate aspects of the formulary management process, reduce the number of drop-shipped items, and develop a plan to measure the success and scalability of its DLA MSPV pilot. VA agreed with GAO's recommendations. For more information, contact Shelby S. Oakley at (202) 512-4841 or OakleyS@gao.gov. Wed, 30 Sep 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-669 What GAO Found To help ensure veterans' access to timely health care services, the Department of Veterans Affairs (VA) purchases care from non-VA providers, known as community care. VA estimates that by fiscal year 2022, its obligations for veterans' community care will total $21.3 billion, an increase of $6.6 billion (45 percent) from fiscal year 2018. This estimated increase reflects implementation of the VA MISSION Act of 2018, which, among other things, expanded veterans' access to community care starting in June 2019. VA Actual and Estimated Community Care Obligations, Fiscal Years 2018 through 2022 aTotals may not sum due to rounding. Each year, VA develops an estimate of the budgetary resources needed to provide VA health care services, including community care, by following established processes. However, when providing data to its consultant responsible for the actuarial modeling, VA does not communicate all relevant information on the quality of its community care utilization and cost data, including any limitations affecting these data. VA officials responsible for providing the data told GAO that they rely on the offices that compile and validate the data for use throughout the department, without collecting information on the data quality from those offices. Such information could improve the actuarial modeling. In addition, VA does not fully assess and communicate to stakeholders the degree of uncertainty inherent in actuarial projections for community care that directly inform the community care budget estimates. VA officials told GAO that stakeholders have an awareness that actual community care experience may differ from projections. By fully assessing and communicating the degree of overall uncertainty associated with its projections, however, VA stakeholders would have more comprehensive information for responding to uncertainty affecting model projections when making decisions regarding VA's community care budget estimates. Why GAO Did This Study In fiscal year 2019, VA obligations for veterans' community care accounted for over 17 percent of all obligations for VA health care. In implementing the VA MISSION Act of 2018, VA continues to focus on community care as a way to improve veterans' access to health care. When informing Congress of the resources needed for community care, VA must ensure its budget estimates, which are based mostly on actuarial projections, are reliable. The process to develop these estimates is inherently complex, as it requires making assumptions based on imperfect information. GAO was asked to review VA's efforts to develop projections for community care. This report (1) describes VA's actual community care obligations for fiscal years 2018 and 2019 and estimated obligations for fiscal years 2020 through 2022 and (2) examines VA's processes related to its use of actuarial modeling for developing budget estimates for community care, among other objectives. GAO reviewed VA data and documents used to develop estimates for the budget requests for fiscal years 2020 through 2022, the most recent years for which data and documents were available. GAO also interviewed officials from VA and its actuarial consultant responsible for developing estimates. What GAO Recommends GAO recommends that VA (1) communicate information on data quality to its actuarial consultant and (2) assess and communicate overall uncertainty associated with actuarial projections to stakeholders. VA concurred with GAO's recommendations. For more information, contact Sharon M. Silas at (202) 512-7114 or silass@gao.gov or Frank Todisco at (202) 512-2700 or todiscof@gao.gov. Wed, 30 Sep 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-643 What GAO Found The Department of Veterans Affairs (VA) established an appointment scheduling process for the Veterans Community Care Program (VCCP) that allows up to 19 days to complete several steps from VA providers creating a referral to community care staff reviewing that referral. However, as the figure shows, VA has not specified the maximum amount of time veterans should have to wait to receive care through the program. GAO previously recommended in 2013 the need for an overall wait-time measure for veterans to receive care under a prior VA community care program. Subsequent to VA not implementing this recommendation, GAO again recommended in 2018 that VA establish an achievable wait-time goal as part of its new community care program (the VCCP). 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 VCCP through routine referrals (non-emergent), and have VA medical center staff—Referral Coordination Team (RCT) and community care staff (CC staff)—schedule the appointments on their behalf. VA has not yet implemented GAO's 2018 recommendation that VA establish an achievable wait-time goal. Under the VA MISSION Act, VA is assigned responsibility for ensuring that veterans' appointments are scheduled in a timely manner—an essential component of quality health care. Given VA's lack of action over the prior 7 years implementing wait-time goals for various community care programs, congressional action is warranted to help achieve timely health care for veterans. Regarding monitoring of the initial steps of the scheduling process, GAO found that VA is using metrics that are remnants from the previous community care program, which are inconsistent with the time frames established in the VCCP scheduling process. This limits VA's ability to determine the effectiveness of the VCCP and to identify areas for improvement. Why GAO Did This Study In June 2019, VA implemented its new community care program, the VCCP, as required by the VA MISSION Act of 2018. Under the VCCP, VAMC staff are responsible for community care appointment scheduling; their ability to execute this new responsibility has implications for veterans receiving community care in a timely manner. GAO was asked to review VCCP appointment scheduling. This report examines, among other issues, the VCCP appointment scheduling process VA established and VA's monitoring of that process. GAO reviewed documentation, such as scheduling policies, and referral data related to the VCCP and assessed VA's relevant processes. GAO conducted site visits to five VAMCs in the first region to transition to VA's new provider network, and interviewed VAMC staff and a non-generalizable sample of community providers receiving referrals from those VAMCs. GAO also interviewed VA and contractor officials. What GAO Recommends GAO recommends that Congress consider requiring VA to establish an overall wait-time measure for the VCCP. GAO is also making three recommendations to VA, including that it align its monitoring metrics with the VCCP appointment scheduling process. VA did not concur with one of GAO's recommendations related to aligning monitoring metrics to VCCP scheduling policy time frames. GAO continues to believe this recommendation is valid, as discussed in the report. For more information, contact Sharon M. Silas at (202) 512-7114 or silass@gao.gov. Mon, 28 Sep 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-652 What GAO Found The Veterans Health Administration's (VHA) Readjustment Counseling Service (RCS) provides counseling through 300 Vet Centers, which can be found in community settings and are separate from other VHA facilities. RCS has set expectations for counselor productivity at Vet Centers. For example, one expectation is for counselors to achieve an average of 1.5 visits for each hour they provide direct services. However, RCS officials told GAO that they have not conducted, and do not have plans to conduct, an evaluation of the expectations. VA Vet Center Productivity Expectations for Counselors Although most counselors met the productivity expectations in fiscal year 2019, counselors GAO spoke with said the expectations led them to change work practices in ways that could negatively affect client care. For example, counselors at one Vet Center told GAO that, to meet productivity expectations, they spend less time with each client to fit more clients into their schedules. Without an evaluation of its productivity expectations, RCS lacks reasonable assurance that it is identifying any unintended or potentially negative effects of the expectations on counselor practices and client care. RCS officials told GAO that by the start of fiscal year 2021 they plan to implement a staffing model to identify criteria for determining staffing needs at Vet Centers. The model incorporates data on counselors' productivity (work hours and number of visits), and total clients to determine criteria for adding or removing a counselor position from a Vet Center. However, the model does not fully address key practices in staffing model design GAO identified in previous work. For example, the model does not include the input of Vet Center counselors, or client data associated with directors, who also provide counseling. As a result, RCS is at risk of making decisions about Vet Center staffing that may not be responsive to changing client needs. Shortages of mental health staff within VHA coupled with the increasing veteran demand for mental health services highlight the critical importance of ensuring appropriate Vet Center staffing. Why GAO Did This Study VHA's RCS provided counseling (individual, group, marriage, and family) and outreach services through Vet Centers to more than 300,000 veterans and their families in fiscal year 2019. In 2017, RCS implemented changes to expectations that it uses to assess Vet Center counselor productivity, setting expectations for counselors' percentage of time with clients and number of client visits. GAO was asked to review Vet Center productivity expectations for counselors and staffing. Among other issues, this report examines the extent to which VHA (1) evaluates its productivity expectations; and (2) assesses Vet Centers' staffing needs. To do this work, GAO reviewed RCS documentation regarding counselors' productivity expectations and analyzed RCS data on counselor productivity expectations and staffing, for fiscal year 2019. GAO interviewed RCS leadership, including district directors, and directors and counselors from 12 Vet Centers, selected for variation in geographic location and total number of clients, among other factors. What GAO Recommends GAO is making four recommendations, including that VHA (1) evaluate Vet Center productivity expectations for counselors; and (2) develop and implement a staffing model that incorporates key practices. The Department of Veterans Affairs concurred with GAO's recommendations and identified actions VHA is taking to implement them. For more information, contact Debra A. Draper at (202) 512-7114 or draperd@gao.gov. Wed, 23 Sep 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-689 What GAO Found From fiscal years 2012 through 2019, the Food and Drug Administration (FDA) obligated a combined total of $14.7 billion to support operations at the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health. During this period, 56 percent of the three centers' total obligations came from user fees, which FDA negotiates with and collects from regulated industries (e.g., manufacturers). The other 44 percent of the centers' total obligations came from regular appropriations. On average, property-related expenses represented 12 percent of the centers' total annual obligations; approximately half of property-related expenses were for rent. Obligations for Three of the Food and Drug Administration's Regulatory Centers by Budget Authority Type, Fiscal Years 2012 through 2019 In managing their personal property (e.g., scientific equipment, computers, and office furniture), these centers did not consistently use quality information related to three phases of asset management: (1) planning for property needs; (2) operating and maintaining property; and (3) reviewing property performance. For example, officials at all three centers described informal, disparate processes for collecting and using information to identify and prioritize personal property needs. Furthermore, center staff conducted these activities differently, potentially resulting in inconsistent asset data. Using quality information—which involves consistently collecting, analyzing, and verifying the accuracy of data—can help agencies effectively manage assets such as personal property. It is a key characteristic integral to effective asset management, criteria GAO developed in prior work based on federal guidance and international standards. By establishing and implementing formal policies for using quality personal property information, FDA and the three centers can more effectively manage their personal property's useful life, plan for and respond to potential changes to the centers' funding and priorities, and maximize the value of the centers' personal property. Why GAO Did This Study Three FDA regulatory centers have primary responsibility for ensuring human medical products' safety, security, and effectiveness. FDA uses personal property and real property (e.g., buildings) to help achieve this oversight mission. Congress included a provision in statute for GAO to examine FDA's expenses related to property at the three centers and evaluate FDA's ability to further its mission through management of those assets. Among other things, this report: (1) identifies the funds FDA obligated for these centers, and (2) assesses FDA's use of quality information to manage the centers' personal property. GAO reviewed financial data and interviewed officials about FDA's obligations from fiscal years 2012 through 2019. In addition, GAO compared criteria related to using quality information to FDA's relevant policies and processes, and interviewed FDA and General Services Administration (GSA) officials about FDA's property management. What GAO Recommends GAO is making four recommendations to FDA and GSA, including that FDA establish and implement formal policies to use quality information to plan for, operate and maintain, and review performance of personal property used by the three centers. The agencies agreed with the recommendations. For more information, contact David Trimble at (202) 512-2834 or Trimbled@gao.gov or Kristen Kociolek at (202) 512-2989 or Kociolekk@gao.gov. Wed, 23 Sep 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-701 What GAO Found In the government’s ongoing response to the COVID-19 pandemic, the Congress and the administration have taken action on multiple fronts to address challenges that have contributed to catastrophic loss of life and profound economic disruption. These actions have helped direct much-needed federal assistance to support many aspects of public life, including local public health systems and private-sector businesses. However, the nation faces continued public health risks and economic difficulties for the foreseeable future. Among other challenges, the public health system, already strained from months of responding to COVID-19 cases, will face the additional task of managing the upcoming flu season. At the same time, many of the federal, state, and local agencies responsible for responding to the ongoing public health emergency are called on to prepare for and respond to the current hurricane season. Timely and concerted federal leadership will be required in responding to these and other challenges. GAO has identified lessons learned and issues in need of continued attention by the Congress and the administration, including the need to collect reliable data that can drive decision-making; to establish mechanisms for accountability and transparency; and to protect against ongoing cyber threats to patient information, intellectual property, public health data, and intelligence. Attention to these issues can help to make federal efforts as effective as possible. GAO has also identified a number of opportunities to help the federal government prepare for the months ahead while improving the ongoing federal response: Medical Supply Chain The Department of Health and Human Services (HHS) and the Federal Emergency Management Agency (FEMA), with support from the Department of Defense (DOD), have taken numerous, significant efforts to mitigate supply shortages and expand the medical supply chain. For example, the agencies have coordinated to deliver supplies directly to nursing homes and used Defense Production Act authorities to increase the domestic production of supplies. However, shortages of certain types of personal protective equipment and testing supplies remain due to a supply chain with limited domestic production and high global demand. The Food and Drug Administration (FDA) and FEMA have both identified shortages, and officials from seven of the eight states GAO interviewed in July and August 2020 identified previous or ongoing shortages of testing supplies, including swabs, reagents, tubes, pipettes, and transport media. Testing supply shortages have contributed to delays in turnaround times for testing results. Delays in processing test results have multiple serious consequences, including delays in isolating those who test positive and tracing their contacts in a timely manner, which can in turn exacerbate outbreaks by allowing the virus to spread undetected. In addition, states and other nonfederal entities have experienced challenges tracking supply requests made through the federal government and planning for future needs. GAO is making the following recommendations: HHS, in coordination with FEMA, should immediately document roles and responsibilities for supply chain management functions transitioning to HHS, including continued support from other federal partners, to ensure sufficient resources exist to sustain and make the necessary progress in stabilizing the supply chain. HHS, 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. HHS and FEMA—working with relevant stakeholders—should devise interim solutions, such as systems and guidance and dissemination of best practices, to help states enhance their ability to track the status of supply requests and plan for supply needs for the remainder of the COVID-19 pandemic response. HHS and the Department of Homeland Security (DHS) objected to GAO’s initial draft recommendations. GAO made revisions based on their comments. GAO maintains that implementation of its modified recommendations is both warranted and prudent. These actions could contribute to ensuring a more effective response by helping to mitigate challenges with the stability of the medical supply chain and the ability of nonfederal partners to track, plan, and budget for ongoing medical supply needs. Vaccines and Therapeutics Multiple federal agencies continue to support the development and manufacturing of vaccines and therapeutics to prevent and treat COVID-19. These efforts are aimed at accelerating the traditional timeline to create a vaccine (see figure). Traditional Timeline for Development and Creation of a Vaccine Note: See figure 5 in the report. As these efforts proceed, clarity on the federal government’s plans for distributing and administering vaccine, as well as timely, clear, and consistent communication to stakeholders and the public about those plans, is essential. DOD is supporting HHS in developing plans for nationwide distribution and administration of a vaccine. In September 2020, HHS indicated that it will soon send a report to Congress outlining a distribution plan, but did not provide a specific date for doing so. GAO recommends that HHS, with support from DOD, establish a time frame for documenting and sharing a national plan for distributing and administering COVID-19 vaccine, and in developing such a plan ensure that it is consistent with best practices for project planning and scheduling and outlines an approach for how efforts will be coordinated across federal agencies and nonfederal entities. DOD partially concurred with the recommendation, clarifying that it is supporting HHS in developing plans for nationwide distribution and administration of vaccine. HHS neither agreed nor disagreed with the recommendation, but noted factors that complicate the publication of a plan. GAO maintains that a time frame is necessary so all relevant stakeholders will be best positioned to begin their planning.On September 16, 2020, HHS and DOD released two documents outlining a strategy for any COVID-19 vaccine. GAO will evaluate these documents and report on them in future work.GAO will also continue to conduct related work, including examining federal efforts to accelerate the development and manufacturing of COVID-19 vaccines and therapeutics. COVID-19 Data Data collected by the Centers for Disease Control and Prevention (CDC) suggest a disproportionate burden of COVID-19 cases, hospitalizations, and deaths exists among racial and ethnic minority groups, but GAO identified gaps in these data. To help address these gaps, on July 22, 2020, CDC released a COVID-19 Response Health Equity Strategy. However, the strategy does not assess whether having the authority to require states and jurisdictions to report race and ethnicity information is necessary to ensure CDC can collect such data. CDC’s strategy also does not specify how it will involve key stakeholders, such as health care providers, laboratories, and state and jurisdictional health departments. GAO recommends that CDC (1) determine whether having the authority to require the reporting of race and ethnicity information for cases, hospitalizations, and deaths is necessary for ensuring more complete data, and if so, seek such authority from Congress; (2) involve key stakeholders to help ensure the complete and consistent collection of demographic data; and (3) take steps to help ensure its ability to comprehensively assess the long-term health outcomes of persons with COVID-19, including by race and ethnicity. HHS agreed with the recommendations. In addition, HHS’s data on COVID-19 in nursing homes do not capture the early months of the pandemic. HHS’s Centers for Medicare & Medicaid Services (CMS) began requiring nursing homes to report COVID-19 data to CDC by May 17, 2020, starting with information as of May 8, 2020, but made reporting prior to May 8, 2020 optional. By not requiring nursing homes to submit data from the first 4 months of 2020, HHS is limiting the usefulness of the data in helping to understand the effects of COVID-19 in nursing homes. GAO recommends that HHS, in consultation with CMS and CDC, develop a strategy to capture more complete data on COVID-19 cases and deaths in nursing homes retroactively back to January 1, 2020. HHS partially agreed with this recommendation by noting the value of having complete data, but expressed concern about the burden of collecting it. GAO maintains the importance of collecting these data to inform the government’s continued response and recovery, and HHS could ease the burden by incorporating data previously reported to CDC or to state or local public health offices. Economic Impact Payments The Department of the Treasury’s (Treasury) Internal Revenue Service (IRS) has issued economic impact payments (EIP) to all eligible individuals for whom IRS has the necessary information to do so; however, not everyone eligible was able to be initially identified. To help ensure all eligible recipients received their payments in a more timely manner, IRS took several actions to address challenges GAO reported on in June, including a policy change—reopening the Non-Filers tool registration period for federal benefit recipients and extending it through September 30—that should allow some eligible recipients to receive supplemental payments for qualifying children sooner than expected. However, Treasury and IRS lack updated information on how many eligible recipients have yet to receive these funds. The lack of such information could hinder outreach efforts and place potentially millions of individuals at risk of missing their payment. GAO recommends that Treasury, in coordination with IRS, (1) update and refine the estimate of eligible recipients who have yet to file for an EIP to help target outreach and communications efforts and (2) make estimates of eligible recipients who have yet to file for an EIP, and other relevant information, available to outreach partners to raise awareness about how and when to file for EIP. Treasury and IRS neither agreed nor disagreed with the recommendations and described actions they are taking in concert with the recommendations to notify around 9 million individuals who may be eligible for an EIP. Coronavirus Relief Fund The Coronavirus Relief Fund (CRF) is the largest program established in the four COVID-19 relief laws that provides aid to states, the District of Columbia, localities, tribal governments, and U.S. territories. Audits of entities that receive federal funds, including CRF payments, are critical to the federal government’s ability to help safeguard those funds. Auditors that conduct single audits follow guidance in the Single Audit Act’s Compliance Supplement, which the Office of Management and Budget (OMB) updates and issues annually in coordination with federal agencies. OMB issued the 2020 Compliance Supplement in August 2020, but the Compliance Supplement specified that OMB is still working with federal agencies to identify the needs for additional guidance for auditing new COVID-19-related programs, including the CRF payments, as well as existing programs with compliance requirement changes. According to OMB, an addendum on COVID-19-related programs, including the CRF payments, will be issued in the fall of 2020. Further delays in issuing this guidance could adversely affect auditors’ ability to issue consistent and timely reports. GAO recommends that OMB, in consultation with Treasury, issue the addendum to the 2020 Compliance Supplement as soon as possible to provide the necessary audit guidance, as many single audit efforts are underway. OMB neither agreed nor disagreed with the recommendation. Guidance for K-12 Schools State and local school district officials tasked with reassessing their operating status and ensuring their school buildings are safe are generally relying on guidance and recommendations from federal, state, and local public health and education officials. However, portions of CDC’s guidance on reopening K-12 schools are inconsistent, and some federal guidance appears misaligned with CDC’s risk-based approach on school operating status. Based on GAO’s review, Education has updated the information and CDC has begun to do so. GAO recommends that CDC ensure that, as it makes updates to its guidance related to schools’ operating status, the guidance is cogent, clear, and internally consistent. HHS agreed with the recommendation. Tracking Contract Obligations Federal agencies are tracking contract actions and associated obligations in response to COVID-19 using a National Interest Action (NIA) code in the Federal Procurement Data System-Next Generation. The COVID-19 NIA code was established in March 2020 and was recently extended until March 31, 2021, while a draft of this report recommending that DHS and DOD extend the code beyond September 30, 2020, was with the agencies for comment. GAO has identified inconsistencies in establishing and closing these codes following previous emergencies, and has continued concerns with the criteria that DHS and DOD rely on to determine whether to extend or close a code and whether the code meets long-term needs. GAO recommends that DHS and DOD make updates to the 2019 NIA Code Memorandum of Agreement so as to enhance visibility for federal agencies, the public, and Congress on contract actions and associated obligations related to disaster events, and to ensure the criteria for extending or closing the NIA code reflect government-wide needs for tracking contract actions in longer-term emergencies, such as a pandemic. DHS and DOD did not agree, but GAO maintains implementation of its recommendation is essential. Address Cybersecurity Weaknesses Since March 2020, malicious cyber actors have exploited COVID-19 to target organizations that make up the health care and public health critical infrastructure sector, including government entities, such as HHS. GAO has identified numerous cybersecurity weaknesses at multiple HHS component agencies, including CMS, CDC, and FDA, over the last 6 years, such as weaknesses in key safeguards to limit, prevent, and detect inappropriate access to computer resources. Additionally, GAO’s March 2019 high-risk update identified cybersecurity and safeguarding the systems supporting the nation’s critical infrastructure, such as health care, as high-risk areas. As of July 2020, CMS, FDA, and CDC had made significant progress by implementing 350 (about 81 percent) of the 434 recommendations GAO issued in previous reports to address these weaknesses. Based on the imminent cybersecurity threats, GAO recommends that HHS expedite implementation of GAO’s prior recommendations regarding cybersecurity weaknesses at its component agencies. HHS agreed with the recommendation. Why GAO Did This Study As of September 10, 2020, the U.S. had over 6.3 million cumulative reported cases of COVID-19 and over 177,000 reported deaths, according to federal agencies. The country also continues to experience serious economic repercussions and turmoil. Four relief laws, including the CARES Act, were enacted as of September 2020 to provide appropriations to address the public health and economic threats posed by COVID-19. As of July 31, 2020, the federal government had obligated a total of $1.6 trillion and expended $1.5 trillion of the COVID-19 relief funds as reported by federal agencies on USAspending.gov. The CARES Act includes a provision for GAO to report bimonthly on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. This third report examines key actions the federal government has taken to address the COVID-19 pandemic and evolving lessons learned relevant to the nation’s response to pandemics. GAO reviewed data, documents, and guidance from federal agencies about their activities and interviewed federal and state officials, as well as industry representatives. What GAO Recommends GAO is making 16 new recommendations for agencies that are detailed in this Highlights and in the report. For more information, contact A. Nicole Clowers at (202) 512-7114 or clowersa@gao.gov. Mon, 21 Sep 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-695R What GAO Found The Defense Health Agency (DHA)—the agency within the Department of Defense (DOD) that administers DOD's health care program, TRICARE—has identified a number of value-based initiatives for potential implementation with civilian providers and hospitals under the TRICARE program. These initiatives aim to help DHA build a value-based health care delivery system, in which providers are rewarded for value of services provided instead of volume of services provided. For these initiatives, value is generally measured in terms of improved health outcomes, enhanced experience of care for the patient, and reduced health care costs over time. GAO found that DHA has identified 20 value-based initiatives, including a program that makes incentive payments for hospitals that meet certain quality metrics for maternity services and a program that promotes adherence to medication regimens by waiving co-payments, among others. According to DHA officials, the 20 initiatives include five that have been implemented (two complete, three underway); three that will be implemented in the future—two with anticipated 2020 start dates are currently on hold due to the department's need to focus on the response to the Coronavirus Disease (COVID-19) pandemic and one that is expected to be implemented in January 2021; eight that are still under review, but no decisions have been made about whether and when they might be implemented; and four that were considered but will not be implemented. Why GAO Did This Study In fiscal year 2019, DOD offered health care services to approximately 9.6 million eligible beneficiaries worldwide through TRICARE, its regionally structured health care program. Beneficiaries may obtain health care services through DOD's direct care system of military hospitals and clinics or from its purchased care system of civilian providers. DOD contracts with private sector companies—referred to as managed care support contractors—to develop and maintain networks of civilian providers and perform other customer service functions for its purchased care system. The National Defense Authorization Act for Fiscal Year 2017 (NDAA 2017) required DOD to develop and implement value-based incentive initiatives in its TRICARE contracts. The NDAA 2017 also included a provision that required GAO to review these initiatives. This correspondence describes the initiatives DHA has developed and the status of each, as of June 2020. To do this work, GAO interviewed knowledgeable DHA officials and analyzed available documentation on each initiative, including decision papers, congressional reports, and Federal Register notices. For more information, contact Debra A. Draper at (202) 512-7114 or draperd@gao.gov. Thu, 17 Sep 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-630 What GAO Found Almost all states have a network of health care volunteers—the Medical Reserve Corps—who can augment federal, state, and local capabilities in response to public health emergencies, such as those arising from wildfires and hurricanes, and infectious disease outbreaks. Having sufficient, trained personnel, such as these volunteers, is critical to a state's capability to respond and recover from public health emergencies. According to federal data, 48 states and the District of Columbia reported 102,767 health care volunteers in 838 Medical Reserve Corps units as of September 2019, with nurses making up 43 percent. Number of Medical Reserve Corps Volunteers by Type, as of September 2019 Note: These data illustrate 90 percent of total health care volunteers. The remaining five types volunteers each make up less than 5 percent of the total. Other Public Health Medical volunteers may include cardiovascular technicians, sonographers, and phlebotomists. Medical Reserve Corps volunteers in states included in GAO's review—Alabama, California, North Carolina, and New Mexico—were deployed in response to natural disasters in 2018 and 2019, migrants at the southern border in 2019, and COVID-19 in 2020. Department of Health and Human Services (HHS) documentation shows these volunteers performed a variety of health care activities, such as providing medical services, setting up and providing support at shelters, and distributing medical supplies. Volunteers from these four states and others also participated in the response to COVID-19 by supporting testing sites, collecting specimens, and performing administrative tasks, such as data entry. For example, one unit deployed four volunteers a day for 3 days to work alongside nurses at a drive-through testing site. In addition to responding to public health emergencies, volunteers participated in preparedness activities, such as an initiative to train the public on how to respond to emergencies. HHS oversees the Medical Reserve Corps program and has assisted units in developing their volunteer capabilities. For example, HHS funded the development of a checklist of activities that should occur during volunteer deployment such as re-verifying medical credentials; provided training to new unit leaders on developing, managing, and sustaining Medical Reserve Corps units; and issued generally accepted practices, such as periodically re-evaluating volunteer recruitment procedures. Why GAO Did This Study The Medical Reserve Corps consists of health care volunteers—medical and public health professionals—who donate their time to help strengthen a response to public health emergencies and build community resilience. These volunteers prepare for and respond to public health emergencies, which may include natural disasters—such as hurricanes and wildfires—as well as disease outbreaks, whether intentional or natural. The Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 included a provision for GAO to review states' use of health care volunteers during public health emergencies. This report describes (1) the number and type of Medical Reserve Corps volunteers; (2) the types of public health emergencies volunteers have participated in; and (3) how HHS has assisted in developing volunteer capabilities. To conduct this work, GAO analyzed data reported to HHS as of September 2019; reviewed HHS documentation on four states' use of volunteers, which GAO selected based on population, number of volunteers, and event; and interviewed officials from HHS who oversee the Medical Reserve Corps program. GAO plans to further examine how states have used health care volunteers to respond to public health emergencies, including COVID-19, and any associated challenges to doing so in a future report. GAO provided a draft of this report to HHS. In response, HHS provided technical comments, which were incorporated as appropriate. For more information, contact Mary Denigan-Macauley at (202) 512-7114 or deniganmacauleym@gao.gov. Mon, 14 Sep 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-664 What GAO Found The Department of Veterans Affairs' (VA) process for identifying on-campus suicides does not include a step for ensuring the accuracy of the number of suicides identified. As a result, its numbers are inaccurate. VA's Veterans Health Administration (VHA) first started tracking on-campus veteran suicides in October 2017, and uses the results to inform VA leadership and Congress. GAO reviewed the data and found errors in the 55 on-campus veteran suicides VHA identified for fiscal years 2018 and 2019, including 10 overcounts (deaths that should not have been reported but were) and four undercounts (deaths that should have been reported but were not).   Examples of Errors on the Department of Veterans Affairs' (VA) List of 55 On-Campus Veteran Suicides for Fiscal Years 2018 and 2019 (as of September 2019) VA has taken some steps to address on-campus veteran suicides, such as issuing guidance and staff training. However, GAO found that the analyses informing these efforts are limited. Specifically, VHA requires root cause analyses—processes to determine what can be done to prevent recurrences of incidents—for some but not all on-campus veteran suicides. According to VHA officials, only 25 percent of on-campus suicides from October 2017 to April 2019 met the criteria for a root cause analysis. does not make use of all relevant information VA collects about these deaths, such as clinical and demographic data collected through other VA suicide prevention efforts. VHA officials said they could not link the different sources of information, but GAO found that selected medical facilities could do so. Without accurate information on the number of suicides and comprehensive analyses of the underlying causes, VA does not have a full understanding of the prevalence and nature of on-campus suicides, hindering its ability to address them. Why GAO Did This Study VA established suicide prevention as its highest clinical priority. In recent years, there have been reports of veterans dying by suicide on VA campuses—in locations such as inpatient settings, parking lots, and on the grounds of cemeteries. GAO was asked to review veteran deaths by suicide on VA campuses. This report examines (1) VA's process to track the number of veterans that died by suicide on VA campuses, and (2) steps VA has taken to address these types of suicides. GAO reviewed the sources of information VHA uses to identify and analyze on-campus veteran suicides, VA and VHA strategic plans and policies related to suicide prevention and reporting, and federal internal control standards. GAO also interviewed VA and VHA central office officials, and officials from three medical facilities that GAO selected because they reportedly had on-campus veteran suicides between fiscal years 2018 and 2019. What GAO Recommends GAO is making three recommendations, including that VA improve its process to accurately identify all on-campus veteran suicides and conduct more comprehensive analyses of these occurrences. VA did not concur with one of GAO's recommendations related to conducting root cause analyses. GAO continues to believe that this recommendation is valid, as discussed in the report. For more information, contact Debra A. Draper at (202) 512-7114 or draperd@gao.gov. Wed, 09 Sep 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-179 What GAO Found The Centers for Medicare and Medicaid Services (CMS) has reimbursed billions of dollars to states for the development, operation, and maintenance of claims processing and information retrieval systems—the Medicaid Management Information Systems (MMIS) and Eligibility and Enrollment (E&E) systems. Specifically, from fiscal year 2008 through fiscal year 2018, states spent a total of $44.1 billion on their MMIS and E&E systems. CMS reimbursed the states $34.3 billion of that total amount (see figure). Money Spent by States and Reimbursed by CMS from 2008–2018 for Medicaid Management Information Systems (MMIS) and Eligibility and Enrollment (E&E) Systems For fiscal years 2016 through 2018, CMS approved 93 percent and disapproved 0.4 percent of MMIS funding requests, while for E&E it approved 81 percent and disapproved 1 percent of the requests. The remaining 6.6 percent of MMIS requests and 18 percent of E&E requests were either withdrawn by states or were pending. GAO estimates that CMS had some level of supporting evidence of its review for about 74 percent of MMIS requests and about 99 percent of E&E requests. However, GAO estimates that about 100 percent of E&E requests and 68 percent of MMIS requests lacked pertinent information that would be essential for indicating that a complete review had been performed. Among CMS requirements for system implementation funding is that states submit an alternatives analysis, feasibility study, and cost benefit analysis. However, GAO found that about 45 percent of such requests it sampled for fiscal years 2016 through 2018 did not include these required documents. The above weaknesses were due, in part, to a lack of formal, documented procedures for reviewing state funding requests. CMS also lacked a risk-based process for overseeing systems after federal funds were provided. CMS provided helpful comments and recommendations to states in selected cases, but in other instances it did not. In two states that had contractors struggling to deliver successful projects, state officials said they had not received recommendations or technical assistance from CMS. The states eventually terminated the projects after spending a combined $38.5 million in federal funds. According to CMS officials, they rely largely on states to oversee systems projects. This perspective is consistent with a 2018 Office of Management and Budget (OMB) decision that federal information technology (IT) grants totaling about $9 billion annually would no longer be tracked on OMB's public web site on IT investment performance. Accordingly, the CMS and Health and Human Services chief information officers (CIO) are not involved in overseeing MMIS or E&E projects. Similarly, 21 of 47 states responding to GAO's survey reported that their state CIO had little or no involvement in overseeing their MMISs. Such non-involvement of officials with duties that should be heavily focused on successful acquisition and operation of IT projects could be hindering states' ability to effectively implement systems. To improve oversight, CMS has begun a new outcome-based initiative that focuses the agency's review of state funding requests on the successful achievement of business outcomes. However, as of February 2020, CMS had not yet established a timeline for including MMIS and E&E systems in the new outcome-based process. CMS had various initiatives aimed at reducing duplication of Medicaid systems (see table). Description and Status of Centers for Medicare and Medicaid Services Initiatives Aimed at Reducing Duplication by Sharing, Leveraging, and Reusing Medicaid Information Technology Initiative Description Implementation status Number of surveyed states reporting use of the initiative Reuse Repository Used by states to collect and share reusable artifacts. Made available in August 2017. As of January 2020, CMS was no longer supporting this initiative. 25 of the 50 reporting states Poplin Project Was to provide free, open-source application program interfaces for states to use in developing their modular Medicaid systems. Initiative never fully implemented. As of January 2020, CMS was no longer supporting this initiative. Three of the 50 reporting states Open Source Provider Screening Module Open-source module for states to use at no charge. Made available in August 2018. As of January 2020, CMS was no longer supporting this initiative. One of the 50 states reported attempting to use the module. Medicaid Enterprise Cohort Meetings A forum where states can discuss sharing, leveraging, and/or reuse of Medicaid technologies. As of January 2020, Cohort meetings were being held on a monthly basis. 47 of the 50 states reported participating in the meetings. Source: GAO analysis of agency data. | GAO-20-179 However, as of January 2020, the agency was no longer supporting most of these initiatives because they failed to produce the desired results. CMS regulations and GAO's prior work have highlighted the importance of reducing duplication by sharing and reusing Medicaid IT. To illustrate the potential for reducing duplication, 53 percent of state Medicaid officials responding to our survey reported using the same contractor to develop their MMIS. Nevertheless, selected states are taking the initiative to share systems or modules. Further support by CMS could result in additional sharing initiatives and potential cost savings. Why GAO Did This Study The Medicaid program is the largest source of health care funding for America's most at-risk populations and is funded jointly by states and the federal government. GAO was asked to assess CMS's oversight of federal expenditures for MMIS and E&E systems used for Medicaid. This report examines (1) the amount of federal funds that CMS has provided to state Medicaid programs to support MMIS and E&E systems, (2) the extent to which CMS reviews and approves states' funding requests for the systems and oversees the use of these funds, and (3) CMS's and states' efforts to reduce potential duplication of Medicaid IT systems. GAO assessed information related to MMIS and E&E systems, such as state expenditure data, federal regulations, and CMS guidance to the states for submitting funding requests, states' system funding requests, and IT project management documents. GAO also evaluated a generalizable sample of approved state funding requests from fiscal years 2016 through 2018 to analyze, among other things, CMS's review and approval process and conducted interviews with agency and state Medicaid officials. GAO also reviewed relevant regulations and guidance on promoting, sharing, and reusing MMIS and E&E technologies; and surveyed 50 states and six territories (hereafter referred to as states) regarding the MMIS and E&E systems, and assessed the complete or partial responses received from 50 states. What GAO Recommends GAO is making nine recommendations to improve CMS's processes for approving and overseeing the federal funds for MMIS and E&E systems and for bolstering efforts to reduce potential duplication. Among these recommendations are that CMS should develop formal, documented procedures that include specific steps to be taken in the advanced planning document review process and instructions on how CMS will document the reviews; develop, in consultation with the HHS and CMS CIOs, a documented, comprehensive, and risk-based process for how CMS will select IT projects for technical assistance and provide recommendations to assist states that is aimed at improving the performance of the systems; encourage state Medicaid program officials to consider involving state CIOs in overseeing Medicaid IT projects; establish a timeline for implementing the outcome-based certification process for MMIS and E&E systems; and identify, prior to approving funding for systems, similar projects that other states are pursuing so that opportunities to share, leverage, or reuse systems or system modules are considered. In written comments on a draft of this report, the department concurred with eight of the nine recommendations, and described steps it had taken and/or planned to take to address them. The department did not state whether it concurred with GAO's recommendation to encourage state officials to consider involving state CIOs in Medicaid IT projects. HHS stated that it was unable to discern evidence as to whether a certain structure contributed to a specific outcome. GAO believes, consistent with federal law, that CIOs are critically important to the success of IT projects. For more information, contact Vijay D’Souza at (202) 512-6240 or dsouzav@gao.gov. Wed, 09 Sep 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-594 What GAO Found The Food and Drug Administration (FDA) has taken steps intended to improve safety at its laboratories, including those that work with hazardous biological agents. Specifically, FDA created the Office of Laboratory Safety (OLS) in 2017 as a safety oversight body for all FDA laboratories. Establishment of FDA's Office of Laboratory Safety (OLS) Note: Prior to March 2019, OLS was referred to as the Office of Laboratory Science and Safety. In coordination with FDA's operating divisions—known as centers—OLS has standardized safety policies, incident reporting, inspections, and safety training. However in creating OLS, FDA did not implement key reform practices that could have helped ensure OLS's effectiveness. For example, FDA's centers and OLS did not reach a shared understanding of OLS's roles and responsibilities—a key practice for effective agency reforms. Although senior agency leaders were involved in developing OLS's strategic plan, disagreements about OLS's role raised by center directors at that time still remain. For example, center directors told GAO that OLS's mission should not include science, laboratory quality management, or inspections. Conversely, the director of OLS said OLS remains committed to its mission as envisioned in the strategic plan, which includes these areas of responsibility. FDA officials said they plan to update the plan in 2021, which presents an opportunity for FDA to address areas of disagreement. In its current form, FDA's laboratory safety program also does not meet the key elements of effective oversight identified in GAO's prior work. For example, The oversight organization should have clear authority to ensure compliance with requirements. However, as part of a 2019 reorganization, FDA placed the OLS director at a lower level than the center directors. Also, OLS does not directly manage the center safety staff responsible for ensuring the implementation of safety policies that OLS develops. As a result, OLS has limited ability to access centers' laboratories—in part because they cannot inspect them unannounced—or to ensure compliance with safety policies. The oversight organization should also be independent from program offices to avoid conflict between program objectives and safety. However, OLS depends on the centers for much of its funding and has had to negotiate with the centers annually for those funds, which can allow center directors to influence OLS priorities through the funding amounts they approve. FDA has not assessed potential independence risks from using center funds for OLS. Without taking steps to do so, FDA's laboratory safety program will continue to compete with the centers' mission objectives and priorities. Why GAO Did This Study In 2014, FDA discovered improperly stored boxes of smallpox virus, posing a risk to individuals who might have been exposed. This raised concerns about the oversight of FDA's laboratories that conduct research on hazardous biological agents. In 2016, GAO made five recommendations to improve FDA's laboratory safety, four of which the Department of Health and Human Services (HHS) had not fully implemented as of July 2020. GAO was asked to examine FDA's efforts to strengthen laboratory safety. This report examines FDA's efforts since GAO's 2016 report to improve safety in its laboratories that work with hazardous biological agents. To conduct this work, GAO reviewed FDA documents; assessed FDA's safety oversight practices against key reform practices and oversight elements GAO identified in prior work; and interviewed FDA officials, including staff and senior leaders at OLS and the three centers that work with hazardous biological agents. What GAO Recommends GAO is making five recommendations to FDA, including to resolve disagreements over roles and responsibilities, to provide OLS with the authority and access to facilities necessary to oversee laboratory safety, and to take steps to assess and mitigate any independence risks posed by how OLS is funded. HHS agreed with all five recommendations. For more information, contact Mary Denigan-Macauley at (202) 512-7114 or deniganmacauleym@gao.gov. Tue, 08 Sep 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-662 What GAO Found Section 3610 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act generally authorizes agencies at their discretion to reimburse a contractor for the cost of paid leave incurred during the pandemic so that it can maintain its workforce in a ready state. Between March 2020—when the CARES Act was enacted—and early July 2020, the Office of Management and Budget (OMB) and each of the seven other agencies in GAO's review issued guidance to implement section 3610. While largely similar, GAO's work identified some differences across these guidance documents, including the extent to which the rates used to calculate these reimbursements could include profit or fees. OMB issued additional guidance on July 14, 2020, that addressed these differences and clarified how agencies should handle each situation. For example, OMB noted that profit or fees should generally not be reimbursed but provided options for addressing situations in which removing profit or fees would be burdensome. OMB advised agencies to report the amount reimbursed using section 3610 authority via contract modifications to the Federal Procurement Data System-Next Generation (FPDS-NG). After excluding reported obligations identified by agency officials as not associated with section 3610 authority, the reported data indicated that agencies made relatively little use of the authority through July 2020 (see figure). However, the Department of Energy (DOE) reimbursed contractors for almost $550 million in paid leave costs, stating it used existing obligations rather than adding funding via a contract modification. As a result, these amounts were not reported to FPDS-NG as section 3610 reimbursements. Obligations Using Section 3610 Authority Reported to the Federal Procurement Data System-Next Generation by Selected Agencies from January 31 to July 20, 2020 Agency officials and industry representatives GAO interviewed identified several factors that limited section 3610 obligations to date, including the absence of dedicated funding. With the exceptions of the Department of Defense (DOD) and DOE, agency officials GAO met with either did not expect a large amount or were uncertain about the level of future requests for section 3610 reimbursements. DOD officials stated that they expected requests amounting to billions of dollars. Why GAO Did This Study In March 2020, Congress passed the CARES Act, which provides over $2 trillion in emergency assistance and healthcare response for individuals, families, and businesses affected by COVID-19. The CARES Act also includes a provision for GAO to review federal contracting pursuant to authorities provided in the Act. This report addresses the implementation of section 3610 of the CARES Act, which authorizes federal agencies to reimburse contractors for paid leave related to the COVID-19 pandemic through September 30, 2020. This report describes (1) the extent to which section 3610 implementation guidance provided by selected federal agencies and OMB differs and (2) the extent to which selected federal agencies reported use of section 3610 authority through July 20, 2020. GAO reviewed relevant guidance issued by OMB and the seven federal agencies with contract obligations greater than $10 billion in fiscal year 2019; interviewed cognizant officials from OMB and each agency; and reviewed comments provided by and spoke with representatives from four industry associations. GAO also analyzed public procurement data reported by selected agencies to FPDS-NG through July 20, 2020 on the use of section 3610 authority. GAO will continue to assess how agencies are implementing section 3610 authority as part of a series of planned reports regarding the federal response to COVID-19. For more information, contact Timothy J. DiNapoli at (202) 512-4841 or dinapolit@gao.gov. Thu, 03 Sep 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-708 Why GAO Did This Study As of August 20, 2020, the U.S. had over 5.5 million cumulative reported cases of COVID-19, and 158,000 reported deaths, according to federal agencies. The country also continues to experience serious economic repercussions and turmoil. Four relief laws, including the CARES Act, were enacted between March and July 2020 to provide appropriations for the response to COVID-19. The CARES Act includes a provision for GAO to report bimonthly on its ongoing monitoring and oversight efforts related to COVID-19. This second report examines federal spending on the COVID-19 response; indicators for monitoring public health and the economy; and the status of matters for congressional consideration and recommendations from GAO’s June 2020 report (GAO-20-625). GAO reviewed data through June 30, 2020 (the latest available) from USAspending.gov, a government website with data from government agencies. GAO also obtained, directly from the agencies, spending data, as of July 31, 2020, for the six largest spending areas, to the extent available. To develop the public health indicators, GAO reviewed research and federal guidance. To understand economic developments, GAO reviewed data from federal statistical agencies, the Federal Reserve, and Bloomberg Terminal, as well as economic research. To update the status of matters for congressional consideration and recommendations, GAO reviewed agency and congressional actions. What GAO Found In response to the national public health and economic threats caused by COVID-19, four relief laws making appropriations of about $2.6 trillion had been enacted as of July 31, 2020. Overall, federal obligations and expenditures government-wide of these COVID-19 relief funds totaled $1.5 trillion and $1.3 trillion, respectively, as of June 30, 2020. GAO also obtained preliminary data for six major spending areas as of July 31, 2020 (see table). COVID-19 Relief Appropriations, Obligations, and Expenditures for Six Major Spending Areas, as of July 2020 Spending area Appropriationsa ($ billions) Preliminary obligationsb ($ billions) Preliminary expendituresb ($ billions) Business Loan Programs 687.3 538.1 522.2c Economic Stabilization and Assistance to Distressed Sectors 500.0 30.4 19.2c Unemployment Insurance 376.4 301.1 296.8 Economic Impact Payments 282.0 273.5 273.5 Public Health and Social Services Emergency Fund 231.7 129.6 95.9 Coronavirus Relief Fund 150.0 149.5 149.5 Total for six spending areas 2,227.4 1,422.2 1,357.0 Source: GAO analysis of data from the Department of the Treasury, USAspending.gov, and applicable agencies. | GAO-20-708 aCOVID-19 relief appropriations reflect amounts appropriated under the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, Pub. L. No. 116-123, 134 Stat. 146; Families First Coronavirus Response Act, Pub. L. No. 116-127, 134 Stat. 178 (2020); CARES Act, Pub. L. No. 116-136, 134 Stat. 281 (2020); and Paycheck Protection Program and Health Care Enhancement Act, Pub. L. No. 116-139, 134 Stat. 620 (2020). These data are based on appropriations warrant information provided by the Department of the Treasury as of July 31, 2020. These amounts could increase in the future for programs with indefinite appropriations, which are appropriations that, at the time of enactment, are for an unspecified amount. In addition, this table does not represent transfers of funds that federal agencies may make between appropriation accounts or transfers of funds they may make to other agencies. bObligations and expenditures data for July 2020 are based on preliminary data reported by applicable agencies. cThese expenditures relate to the loan subsidy costs (the loan’s estimated long-term costs to the United States government). The CARES Act included a provision for GAO to assess the impact of the federal response on public health and the economy. The following are examples of health care and economic indicators that GAO is monitoring. Health care. GAO’s indicators are intended to assess the nation’s immediate response to COVID-19 as it first took hold, gauge its recovery from the effects of the pandemic over the longer term, and determine the nation’s level of preparedness for future pandemics, involving subsequent waves of either COVID-19 or other infectious diseases. For example, to assess the sufficiency of testing—a potential indicator of the system’s response and recovery—GAO suggests monitoring the proportion of tests in a given population that are positive for infection. A higher positivity rate can indicate that testing is not sufficiently widespread to find all cases. That is higher positivity rates can indicate that testing has focused on those most likely to be infected and seeking testing because they have symptoms, and may not be detecting COVID-19 cases among individuals with no symptoms. Although there is no agreed-upon threshold for the test positivity rate, governments should target low positivity rates. The World Health Organization recommends a test positivity rate threshold of less than 5 percent over a 14-day period. As of August 12, 2020, 12 states and the District of Columbia had met this threshold (38 states had not). Resolve to Save Lives, another organization, recommends a threshold of less than 3 percent over a 7-day period, and 11 states and the District of Columbia had met this threshold (39 states had not) as of August 12, 2020. GAO also suggests monitoring mortality from all causes compared to historical norms as an indicator of the pandemic’s broad effect on health care outcomes. Mortality rates have tended to be consistent from year to year. This allows an estimation of how much mortality rose with the onset of the pandemic, and provides a baseline by which to judge a return to pre-COVID levels. According to Centers for Disease Control and Prevention data, about 125,000 more people died from all causes January 1–June 13 than would normally be expected (see figure). CDC Data on Higher-Than-Expected Weekly Mortality, January 1 through June 13, 2020 Note: The figure shows the number of deaths from all causes in a given week that exceeded the upper bound threshold of expected deaths calculated by CDC on the basis of variation in mortality experienced in prior years. Changes in the observed numbers of deaths in recent weeks should be interpreted cautiously as this figure relies on provisional data that are generally less complete in recent weeks. Data were accessed on July 16, 2020. Economy. GAO updated information on a number of indicators to facilitate ongoing and consistent monitoring of areas of the economy supported by the federal pandemic response, in particular the COVID-19 relief laws. These indicators suggest that economic conditions—including for workers, small businesses, and corporations—have improved modestly in recent months but remain much weaker than prior to the pandemic. In June and July initial regular unemployment insurance (UI) claims filed weekly averaged roughly 1.4 million (see figure), which was six and a half times higher than average weekly claims in 2019, but claims have decreased substantially since mid-March, falling to 971,000 in the week ending August 8, 2020. Increasing infections in some states and orders to once again close or limit certain businesses are likely to pose additional challenges for potentially fragile economic improvements, especially in affected sectors, such as the leisure and hospitality sector. National Weekly Initial Unemployment Insurance Claims, January 2019–July 2020 Note: See figure 5 in the report. As GAO reported in June, consistent with the urgency of responding to serious and widespread health issues and economic disruptions, federal agencies gave priority to moving swiftly where possible to distribute funds and implement new programs designed to help small businesses and the newly unemployed, for example. However, such urgency required certain tradeoffs in achieving transparency and accountability goals. To make mid-course corrections, GAO made three recommendations to federal agencies: To reduce the potential for duplicate payments from the Paycheck Protection Program (PPP)—a program that provides guaranteed loans through lenders to small businesses—and unemployment insurance, GAO recommended that the Department of Labor (DOL), in consultation with the Small Business Administration (SBA) and the Department of the Treasury (Treasury), immediately provide information to state unemployment agencies that specifically addresses PPP loans, and the risk of improper unemployment insurance payments. DOL issued guidance on August 12, 2020, that, among other things, clarified that individuals working full-time and being paid through PPP are not eligible for UI. To recoup economic impact payments totaling more than $1.6 billion sent to decedents, GAO recommended that the Internal Revenue Service (IRS) consider cost-effective options for notifying ineligible recipients of economic impact payments how to return payments. IRS has taken steps to address this recommendation. According to a Treasury official, nearly 70 percent of the payments sent to decedents have been recovered. However, GAO was unable to verify that amount before finalizing work on this report. GAO is working with Treasury to determine the number of payments sent to decedents that have been recovered. Treasury was considering sending letters to request the return of remaining outstanding payments but has not moved forward with this effort because, according to Treasury, Congress is considering legislation that would clarify or change payment eligibility requirements. To reduce the potential for fraud and ensure program integrity, 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 has begun developing oversight plans for PPP but has not yet finalized or implemented them. In addition, to improve the government’s response efforts, GAO suggested three matters for congressional consideration: GAO urged Congress to take legislative action to require the Department of Transportation (DOT) to work with relevant agencies and stakeholders, such as HHS, the Department of Homeland Security (DHS), and international organizations, to develop a national aviation-preparedness plan to ensure safeguards are in place to limit the spread of communicable disease threats from abroad, while also minimizing any unnecessary interference with travel and trade. In early July 2020, DOT collaborated with HHS and DHS to issue guidance to airports and airlines for implementing measures to mitigate the public health risks associated with COVID-19, but it has not developed a preparedness plan for future communicable disease threats. DOT has maintained that HHS and DHS should lead such planning efforts as they are responsible for communicable disease response and preparedness planning, respectively. In June 2020, HHS stated that it is not in a position to develop a national aviation-preparedness plan as it does not have primary jurisdiction over the entire aviation sector or the relevant transportation expertise. In May 2020, DHS stated that it had reviewed its existing plans for pandemic preparedness and response activities and determined it is not best situated to develop a national aviation-preparedness plan. Without such a plan, the U.S. will not be as prepared to minimize and quickly respond to future communicable disease events. GAO also urged Congress to amend the Social Security Act to explicitly allow the Social Security Administration (SSA) to share its full death data with Treasury for data matching to help prevent payments to ineligible individuals. In June 2020, the Senate passed S.4104, referred to as the Stopping Improper Payments to Deceased People Act. If enacted, the bill would allow SSA to share these data with Treasury's Bureau of the Fiscal Service to avoid paying deceased individuals. Finally, GAO urged Congress to use GAO's Federal Medical Assistance Percentage (FMAP) formula for any future changes to the FMAP—the statutory formula according to which the federal government matches states' spending for Medicaid services—during the current or any future economic downturn. Congress has taken no action thus far on this issue. GAO incorporated technical comments received the Departments of Labor, Commerce, Health and Human Services, Transportation, and the Treasury; the Federal Reserve; Office of Management and Budget; and Internal Revenue Service. The Small Business Administration commented that GAO did not include information on actions taken and controls related to its loan forgiveness program or its plans for loan reviews. GAO plans to provide more information on these topics in its next CARES Act report. For more information, contact A. Nicole Clowers at (202) 512-7114 or clowersa@gao.gov. Mon, 31 Aug 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-634R What GAO Found GAO performed 31 covert tests to selected sales representatives and stated that we had pre-existing conditions, such as diabetes or heart disease, and we requested coverage for these conditions to see if the sales representative directed GAO's undercover agents to a comprehensive Patient Protection and Affordable Care Act (PPACA)-compliant plan, or a PPACA-exempt plan that does not cover what we requested. As part of these tests, GAO gauged whether sales representatives engaged in potentially deceptive practices, such as making false or misleading statements about coverage or omitting material information about coverage. The results of the covert tests ranged from sales representatives appropriately explaining to GAO's undercover agents that a PPACA-exempt plan would not cover the pre-existing condition the undercover agents stated that they had, to engaging in potentially deceptive marketing practices that misrepresented or omitted information about the products they were selling. Specifically, in 21 of 31 covert tests, the sales representative appropriately referred undercover agents to a PPACA-compliant plan. In two of 31 covert tests, the sales representatives did not appear to engage in deceptive marketing practices but were not always consistent or clear in their explanation of the type of coverage and plans they were selling. In the remaining eight of 31 covert tests, the sales representatives engaged in potentially deceptive marketing practices, such as claiming the pre-existing condition was covered when the health plan documents GAO received after purchase said otherwise. GAO plans to refer these eight cases of potential deceptive marketing practices to the Federal Trade Commission (FTC) and corresponding state insurance commissioners' offices for follow-up as appropriate. Why GAO Did This Study Millions of Americans obtain health insurance coverage in the individual market, which consists mainly of private plans sold directly to consumers without access to group coverage. While generally regulated by states, starting in 2014, PPACA established a number of new federal requirements for the individual health insurance market. For example, PPACA prohibited insurers from excluding coverage or charging higher premiums for pre-existing conditions and required that individual market plans cover a set of essential health benefits, including coverage for mental health and substance abuse disorder services, prescription drugs, and maternity and newborn care. Certain types of health coverage arrangements that can be sold directly to consumers do not have to comply with some or all of PPACA's individual market requirements and, as a result, may be less expensive, but also offer more limited benefits compared to PPACA-compliant plans. Recent changes to federal law and regulations could result in the increased use of PPACA-exempt health coverage arrangements as alternatives to PPACA-compliant plans in the individual market. For example, in 2018, federal regulations expanded the availability of short term, limited duration insurance (STLDI) plans, a type of PPACA-exempt arrangement. In addition, starting January 1, 2019, individuals who fail to maintain "minimum essential coverage," as required by PPACA, no longer face a tax penalty. Further, the devastating economic effects of the Coronavirus Disease 2019 (COVID-19) pandemic could create additional demand for affordable health coverage, including PPACA-exempt plans.  With these changes, and because of their lower relative costs, PPACA-exempt health coverage arrangements may be attractive to consumers, particularly those who find it difficult to afford PPACA-compliant plans. However, such arrangements generally do not need to follow PPACA's requirement that plans in the individual market be presented to consumers in defined categories outlining the extent to which they are expected to cover medical care. As a result, depending on how they are marketed and sold, PPACA-exempt arrangements could present risks for consumers, if, for example, they buy them mistakenly believing that coverage is as comprehensive as for PPACA-compliant plans. GAO was asked to obtain insights on the marketing and sales practices of insurance sales representatives who sell PPACA-exempt plans. In this report, GAO describes the results of covert tests we conducted involving selected sales representatives, when contacted by individuals stating that they had pre-existing conditions. In this regard, GAO agents performed a number of covert tests (i.e., undercover phone calls) from November 2019 through January 2020 posing as individuals needing to purchase health insurance to cover pre-existing conditions. GAO also discussed the marketing and oversight of PPACA-exempt arrangements with senior officials from federal agencies, including the FTC, and Centers of Medicare and Medicaid Services (CMS) within the Department of Health and Human Services (HHS), as well as the National Association of Insurance Commissioners (NAIC)5. GAO provided a draft of this product to FTC, HHS, and NAIC for review and comment. FTC, HHS, and NAIC provided technical comments, which GAO incorporated as appropriate. HHS provided additional written comments on a draft of this report. For more information, contact Seto Bagdoyan at (202)-6722 or bagdoyans@gao.gov. Mon, 24 Aug 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-611R What GAO Found The Department of Defense (DOD) screens for eating disorders for all applicants entering into the military but does not specifically screen servicemembers for eating disorders after entrance. However, after joining the military, servicemembers receive annual health screenings, and medical personnel may be able to diagnose eating disorders during in-person physical exams. Service branch behavioral health specialists told GAO that DOD medical personnel are trained to notice signs of eating disorders, such as changes in vital signs and emaciated appearance. DOD is examining ways to improve its screening of eating disorders in the military and recently expanded the available research funding for eating disorders in its Peer-Reviewed Medical Research Program (PRMRP). DOD provides health care services to approximately 9.5 million eligible beneficiaries, including services to treat those diagnosed with eating disorders, through TRICARE, DOD’s regionally structured health care system. Servicemembers can obtain these services at military treatment facilities—referred to as direct care—or receive care purchased from civilian providers—referred to as purchased care. DOD officials told us that the specialized level of care necessary to treat eating disorders is available to TRICARE beneficiaries through purchased care, rather than direct care. The Defense Health Agency (DHA), which oversees the TRICARE program, uses two contractors to develop regional provider networks. According to the two TRICARE contractors’ data for purchased care, as of spring 2020, there were 166 eating disorder facilities located in 32 states throughout the country and the District of Columbia. The facilities vary by geographic location, population served, and level of treatment provided: Geography: About half of the 166 facilities (79) are located in the following five states: California (24), Florida (18), Illinois (15), Texas (13), and Virginia (nine).  Population: Of the 166 eating disorder facilities, over three-quarters provide treatment to both adult (132 facilities) and child and adolescent (132 facilities) populations. Level of Treatment: Most facilities provide inpatient hospitalization programs, which are for serious cases requiring medical stabilization (81 facilities); partial hospitalization, which are day programs providing treatment 5 to 7 days a week (133 facilities); or intensive outpatient programs, which are treatment programs providing therapy 2 to 6 days a week (107 facilities). About one-fifth of the facilities (35) provide residential treatment services, which are living accommodations providing intensive therapy and 24-hour supervision. TRICARE contractors have met with some challenges entering into contracts with eating disorder treatment facilities in certain areas of the country, according to DHA officials and both contractors. However, both contractors told GAO they consider it their responsibility to ensure beneficiaries receive the care they need regardless of the location of the facility. No access-to-care complaints related to eating disorder treatment were reported by TRICARE beneficiaries, according to the most recent DHA data for years 2018 through 2019. Why GAO Did This Study Eating disorders are complex conditions affecting millions of Americans and involve dangerous eating behaviors, such as the restriction of food intake. They can have a severe impact on heart, stomach, and brain functionality, and they significantly raise the risk of mortality. Many with eating disorders also experience co-occurring conditions such as depression. Research has yielded a range of estimates of the number of servicemembers with an eating disorder, due to differences in research methods. For example, a 2018 DOD study concluded that servicemembers likely experienced eating disorders at rates that are comparable to rates in the general population, while other survey-based research suggested the number of servicemembers with eating disorders may be higher than those with a medical diagnoses of such disorders. The potential effects that eating disorders can have on the health and combat readiness of servicemembers and their dependents underscores the importance of screening and treating this population. GAO was asked to provide information on eating disorders among servicemembers and their dependents. To describe how DOD screens for eating disorders among servicemembers, GAO reviewed DOD policies related to health screening and interviewed behavioral health specialists from the military branches. To understand approaches and challenges with implementing screening in a military environment, any planned or ongoing DOD-sponsored research related to this topic, and available eating disorder treatment, GAO interviewed representatives from the Eating Disorder Coalition, Uniformed Services University of Health Sciences, and the University of Kansas. To describe how DOD provides eating disorder treatment to servicemembers and their dependents, GAO interviewed DHA officials and TRICARE contractors and reviewed the TRICARE policy manual to identify the types of eating disorder diagnoses and treatments that are covered through direct and purchased care. GAO received data from the two TRICARE contractors related to the availability of eating disorder treatment services as of spring 2020. For more information, contact Sharon Silas at (202) 512-7114 or Silass@gao.gov. Fri, 07 Aug 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-616 What GAO Found Substance use disorders (SUD)—the recurrent use of alcohol or illicit drugs causing significant impairment—affected about 19.3 million adults in the United States in 2018, according to the Substance Abuse and Mental Health Services Administration. State Medicaid programs have the option to cover services offered by peer providers—individuals who use their own lived experience recovering from SUD to support others in recovery. GAO's review of Medicaid and CHIP Payment and Access Commission data found that, in 2018, 37 states covered peer support services for adults with SUDs in their Medicaid programs. Medicaid Coverage of Peer Support Services for Adults with Substance Use Disorders, 2018 Officials from the three states GAO reviewed—Colorado, Missouri, and Oregon—reported that their Medicaid programs offered peer support services as a complement, rather than as an alternative, to clinical treatment for SUD. Missouri officials said that peer providers did not maintain separate caseloads and were part of treatment teams, working in conjunction with doctors and other clinical staff. Similarly, officials in Colorado and Oregon said peer support services were only offered as part of a treatment plan. State officials reported that peer support services could be offered as an alternative to clinical treatment outside of Medicaid using state or grant funding. Why GAO Did This Study SUD treatment can help individuals reduce or stop substance use and improve their quality of life. In 2007, the Centers for Medicare & Medicaid Services recognized that peer providers could be an important component of effective SUD treatment, and provided guidance to states on how to cover peer support services in their Medicaid programs. However, states have flexibility in how they design and implement their Medicaid programs, and coverage for peer support services is an optional benefit. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act included a provision for GAO to report on peer support services under Medicaid. This report describes, among other objectives, the extent to which state Medicaid programs covered peer support services for adult beneficiaries with SUDs nationwide, and how selected state Medicaid programs offered peer support services for adult beneficiaries with SUDs. GAO obtained state-by-state data from the Medicaid and CHIP Payment and Access Commission on 2018 Medicaid coverage of peer support services. GAO also reviewed information and interviewed officials from a nongeneralizable sample of three states, which GAO selected for a number of reasons, including to obtain variation in delivery systems used. The Department of Health and Human Services provided technical comments on a draft of this report, which GAO incorporated as appropriate. For more information, contact Carolyn L. Yocom at (202) 512-7114 or yocomc@gao.gov. Thu, 06 Aug 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-617 What GAO Found Of the medications used to treat opioid use disorder (OUD), only buprenorphine is both a controlled substance and available as an injection or implant. Buprenorphine is used to treat patients with OUD because it reduces or eliminates opioid withdrawal symptoms and blunts the euphoria or dangerous side effects of other opioids, such as heroin. When used to treat OUD, buprenorphine, in any form, is subject to additional laws and regulations that are overseen by the Drug Enforcement Administration (DEA), within the Department of Justice (DOJ) and the Substance Abuse and Mental Health Services Administration (SAMHSA), within the Department of Health and Human Services (HHS). To ensure patient safety when injectable and implantable buprenorphine is used, the Food and Drug Administration (FDA), within HHS has also required drug companies to establish risk evaluation and mitigation strategies to help ensure the benefits of these medications outweigh their risks. Providers and pharmacies must follow a number of specific steps based on federal requirements when providing treatment with injectable and implantable buprenorphine. Providers are responsible for prescribing, storing, and administering injectable and implantable buprenorphine, while pharmacies are responsible for dispensing these medications (see figure). Representatives GAO interviewed from provider groups and pharmacies said they did not find the steps involved in treating patients to be difficult overall. However, they stated that careful and timely coordination with each other and patients is needed at key steps of the process to ensure that the patient receives treatment. Representatives from provider groups and pharmacies reported that the risk of diversion of injectable and implantable buprenorphine is low. For example, all of the provider groups GAO spoke with said that diversion of injectable or implantable buprenorphine is unlikely, and representatives from three of the six provider groups said that the design of these formulations reduces opportunities for diversion due to how they are administered. Process for Treating Opioid Use Disorder with Injectable and Implantable Buprenorphine The use of injectable and implantable buprenorphine to treat OUD is relatively low compared to oral forms of buprenorphine. HHS has reported that about 7,250 prescriptions were issued for injectable and implantable buprenorphine in fiscal year 2019, compared to over 700,000 patients who received buprenorphine prescriptions for oral formulations to treat OUD or pain in that year. Why GAO Did This Study In 2018, SAMHSA estimated that about one-quarter of the estimated 2 million people with OUD had received some form of substance use treatment in the prior year. One form of treatment—medication-assisted treatment (MAT)— combines behavioral therapy with the use of certain medications. HHS has identified expanding access to treatment for OUD as an important strategy for reducing opioid morbidity and mortality, which includes increasing the number of injectable and implantable buprenorphine prescriptions. Congress included a provision in the SUPPORT Act for GAO to review access to and the potential for the diversion of controlled substances administered by injection or implantation. This report focuses on injectable and implantable controlled substances that can be used to treat OUD and specifically, describes the process for treating OUD with injectable and implantable buprenorphine and what is known about their use. GAO reviewed laws, regulations, and documentation from DEA, FDA, and SAMHSA governing the process of providing treatment with buprenorphine and interviewed officials from those agencies. GAO also interviewed representatives from stakeholder groups representing MAT providers; drug companies that manufacture injectable or implantable buprenorphine; and pharmacies that dispense these medications. HHS and DOJ reviewed a draft of this report, and GAO incorporated their technical comments, as appropriate. For more information, contact James Cosgrove at (202) 512-7114 or cosgrovej@gao.gov. Tue, 04 Aug 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-593 What GAO Found Genetic counselors and medical geneticists are two groups who typically work together to provide genetic services, such as genetic testing and counseling. Genetic counselors have at least a master's degree in genetic counseling and assess individuals or families with or at risk for genetic conditions, and provide counseling and education on test results. Medical geneticists are typically physicians who specialize in medical genetics and genomics, and provide comprehensive genetic services, ranging from diagnosis and interpretation of test results to the management and treatment of genetic conditions. GAO's analysis of data from the professional organizations representing this workforce shows the number of genetic counselors certified to provide genetic counseling services has nearly doubled since 2009, and is projected to continue growing. The data show there were approximately 4,700 certified genetics counselors in the United States in 2019. The data also show the number of new medical geneticists has increased modestly since 2009, and the total number certified in the United States was approximately 1,240 as of April 2020. There is no widely accepted measure for how many genetic counselors and medical geneticists should be available; however, representatives from professional organizations GAO interviewed stated that demand for genetic services is rising. Data from the professional organizations representing the genetic counselor and medical geneticist workforces, as well as data from the Census Bureau, also show the number of genetic counselors and medical geneticists varied across states. States averaged seven genetic counselors per 500,000 people in 2019 and two medical geneticists per 500,000 people in 2020. Genetic counselors and medical geneticists primarily practice in hospital settings. Distribution of Genetic Counselors by State, 2019 Why GAO Did This Study Advances in genetic technology and research have increased the amount of information available to individuals and providers, and may have increased the demand for genetic services. The medical genetics workforce—which includes genetic counselors and medical geneticists—plays an essential role in providing access to genetic services. Some studies have identified concerns with the size of the medical genetics workforce and its ability to meet the current and future demand for genetic services. A House Committee on Appropriations report included a provision for GAO to conduct an analysis of the medical genetics workforce. This report describes, among other objectives, what is known about changes in the size of the genetic counselor and medical geneticist workforces; and what is known about the geographic distribution of these workforces. GAO reviewed relevant studies of the genetic counselor and medical geneticist workforces; interviewed agency officials and professional organizations representing each workforce; and analyzed the most recent available data on the size and distribution of each workforce in the United States, as well as population data from the Census Bureau. GAO provided a draft of this report to the Department of Health and Human Services and the Department of Labor. The Department of Health and Human Services provided technical comments, which GAO incorporated as appropriate. For more information, contact James Cosgrove at (202) 512-7114 or CosgroveJ@gao.gov. Fri, 31 Jul 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-636R What GAO Found Stakeholders GAO interviewed and studies GAO reviewed identified three factors that affect access to follow-up care for childhood cancer survivors—individuals of any age who were diagnosed with cancer from ages 0 through 19. These factors are care affordability, survivors' and health care providers' knowledge of appropriate care, and proximity to care. Childhood cancer survivors need access to follow-up care over time for serious health effects known as late effects—such as developmental problems, heart conditions, and subsequent cancers—which result from their original cancer and its treatment. Affordability: Survivors of childhood cancer may have difficulty paying for follow-up care, which can affect their access to this care. For example, one study found that survivors were significantly more likely to have difficulty paying medical bills and delay medical care due to affordability concerns when compared to individuals with no history of cancer. Knowledge: Survivors' access to appropriate follow-up care for late effects of childhood cancer can depend on both survivors' and providers' knowledge about such care, which can affect access in various ways, according to stakeholders GAO interviewed and studies GAO reviewed: Some survivors may have been treated for cancer at an early age and may have limited awareness of the need for follow- up care. Some primary or specialty care providers may not be knowledgeable about guidelines for appropriate follow-up care, which can affect whether a survivor receives recommended treatment. Follow-up care may include psychosocial care (e.g., counseling), and palliative care (e.g., pain management). Proximity: Survivors may have difficulty reaching appropriate care settings. Stakeholders GAO interviewed and studies GAO reviewed noted that childhood cancer survivors may have to travel long distances to receive follow-up care from multidisciplinary outpatient clinics—referred to as childhood cancer survivorship clinics. The lack of proximity may make it particularly difficult for survivors with limited financial resources to adhere to recommended follow-up care. The National Cancer Institute (NCI) and the Centers for Disease Control and Prevention (CDC)—agencies within the Department of Health and Human Services (HHS) that conduct activities specific to childhood cancer survivors, including research about access to care—have taken steps to implement three provisions in the Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2018 (Childhood Cancer STAR Act) relevant to access to care for survivors. For example, CDC has awarded a contract to develop software to improve the collection of information on individuals with childhood cancer, and NCI has funded three research projects focused on interventions aimed at addressing adverse outcomes among childhood cancer survivors. NCI has also funded research to study the health status and use of follow-up services of 2,000 young adult survivors. Why GAO Did This Study Stakeholders have raised questions about the ability of childhood cancer survivors to access needed follow-up care. According to the most recent data available, approximately 465,000 childhood cancer survivors—children, adolescents, and adults—were alive in the United States as of January 1, 2017. Although the 5-year survival rate for childhood cancer has increased from about 62 percent in the mid-1970s to about 86 percent in the mid-2010s, childhood cancer survivors may face late effects, which could require follow-up care across multiple stages of their lives. The conference report accompanying Public Law 115-245 included a provision for GAO to report on barriers to obtaining medical care for childhood cancer survivors, including psychosocial services and palliative care. This report identifies factors reported to affect access to follow-up care for this population. GAO spoke with officials from NCI and CDC and interviewed stakeholders such as providers who care for childhood cancer survivors, professional associations, and advocacy groups. Additionally, GAO reviewed peer-reviewed studies related to access to care for survivors, outcomes of treatment they may receive, and factors that may affect their access to follow-up care. To supplement this work, GAO reviewed the status of selected HHS activities to support access to care for childhood cancer survivors, including steps taken to implement selected provisions in the Childhood Cancer STAR Act. GAO provided a draft of this report to HHS for review and comment. HHS provided technical comments, which GAO incorporated as appropriate. For more information, contact Jessica Farb at (202) 512-7114 or FarbJ@gao.gov. Fri, 31 Jul 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-601R What GAO Found The Department of Health and Human Services' (HHS) Biomedical Advanced Research and Development Authority has taken steps towards implementing an authority provided by the 21st Century Cures Act to accelerate the development of medical countermeasures. Medical countermeasures are drugs, vaccines, and devices to diagnose, treat, prevent, or mitigate potential health effects of exposure to chemical, biological, radiological, and nuclear threats. However, as of June 2020, HHS had not selected a medical countermeasures innovation partner—an independent, nonprofit entity that the 21st Century Cures Act authorizes HHS to partner with to use venture capital practices and methods to invest in companies developing medical countermeasures. Towards implementing the authority, HHS has developed a vision for the innovation partner, staffed a division to manage HHS's medical innovation partnership and determined an initial amount of funding needed, solicited and considered feedback from venture capital and other stakeholders, and developed preliminary plans for structuring and overseeing the partnership. HHS officials explained this type of partnership approach was new to the agency and required due diligence to develop. According to agency officials, the innovation partner will allow HHS to invest in potentially transformative medical countermeasures that have the potential to benefit the government. For example, the innovation partner could invest in innovative wearable technologies to help early detection of viral infections. HHS officials told GAO that the partner, which is required by law to be a nonprofit entity, will be required to reinvest BARDA's revenues generated from government investments into further investments made through the partnership. BARDA's ultimate goal will be to use these revenues to fund new investments. According to a review of stakeholder comments submitted to HHS, potential venture capital partners identified concerns regarding aspects of the agency's plans for the innovation partner, which the stakeholders indicated could hinder HHS's implementation of the authority. For example, there is a statutory limit to the annual salary that can be paid to an individual from HHS's annual appropriation, which some stakeholders indicated was too low to attract an entity to manage the innovation partner funds. HHS officials told GAO they are assessing options to mitigate some of these concerns, but that plans will not be final until they select the partner. GAO provided a draft of this correspondence to HHS and the Department of Defense for review and comment. HHS did not provide comments on this report and DOD provided technical comments that we incorporated as appropriate. Why GAO Did This Study The COVID-19 pandemic and other public health emergencies caused by chemical, biological, radiological, and nuclear agents or emerging infectious diseases raise concern about the nation's vulnerability to, and capacity to prevent or mitigate, potential health effects from exposure to such threats. The 21st Century Cures Act authorized HHS to partner with a private, nonprofit entity that can use venture capital practices and methods to invest in companies developing promising, innovative, medical countermeasures. The 21st Century Cures Act included a provision for GAO to review activities conducted under the innovation partner authority. This report describes the status of HHS's implementation of the authority. GAO reviewed relevant statutes and HHS documentation regarding its plans and actions taken to implement the authority, reviewed responses HHS received to the two requests for information it used to collect information from venture capital and other stakeholders, interviewed HHS officials, and interviewed officials from the Department of Defense, which has partnered with a private, nonprofit entity to make investments using venture capital practices. For more information, contact Mary Denigan-Macauley at (202) 512-7114 or DeniganMacauleyM@gao.gov. Wed, 29 Jul 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-697T What GAO Found The Department of Veterans Affairs (VA) pays over $1 billion a year to state veterans homes (SVH)—homes owned and operated by the states—to provide nursing home care to approximately 20,000 veterans. In fiscal year 2019, VA paid SVHs $1.17 billion for an average daily census of 20,072 veterans (51 percent of the total veterans receiving nursing home care through VA). Further, VA projects its payments to SVHs will continue to increase; VA projects it will pay $1.7 billion to SVHs to provide care to veterans in fiscal year 2022. VA oversees the quality of care veterans receive at SVHs mainly through annual inspections that VA hires a contractor to perform. In its July 2019 report, GAO found that VA's SVH contractor performed the required annual inspections for all SVHs in 2018, but VA needed to take action to enhance its oversight of SVHs and to ensure that information on quality of care provided in this setting is publicly available to veterans. Specifically, GAO found the following: VA does not require its SVH contractor to identify all failures to meet quality standards during its inspections as deficiencies . For example, GAO found that VA allows its SVH contractor to cite some failures to meet quality standards as “recommendations,” rather than as deficiencies. VA officials said they do not track or monitor the nature of the recommendations or whether they have been addressed. As a result, VA does not have complete information on all failures to meet quality standards at SVHs and cannot track this information to identify trends in quality across these homes. VA is not conducting all monitoring of its SVH contractor. GAO found that, at the time of its review, VA had not monitored the SVH contractor's performance of inspections through regular observational assessments to ensure that contractor staff effectively determine whether SVHs are meeting required standards. Specifically, VA officials said they intended to observe the SVH contractor's inspections on a quarterly basis; however, at the time of GAO's review, VA officials could not recall when VA last observed the SVH contractor's inspections. In July 2020, VA provided information indicating that they will regularly monitor the SVH contractor's performance in conducting inspections through observational assessments. VA does not share information on the quality of SVHs on its website. GAO found that, while VA provides information on the quality of other nursing home care settings on its website, it does not do so for SVHs. According to VA officials, there is no requirement to provide information on SVH quality on its website, as SVHs are owned and operated by the states. VA is the only federal agency that conducts regular oversight inspection on the quality of care of all SVHs and, as a result, is the only agency that could share such quality information on its website. Why GAO Did This Study Veterans—like over a million other Americans—rely on nursing home care to help meet their health needs. For eligible veterans whose health needs require skilled nursing and personal care, VA provides or pays for nursing home care in three nursing home settings: the VA-owned and -operated community living centers, public- or privately owned community nursing homes, and state-owned and -operated SVHs. In fiscal year 2019, VA provided or paid for nursing home care for over 39,000 veterans. The majority of these veterans received care at SVHs. This statement summarizes the GAO's July 2019 report, GAO-19-428 , with a focus on issues related to SVHs. Specifically, it describes the: (1) use of and expenditures for SVHs, (2) inspections used by VA to assess the quality of SVH care and VA's oversight of the inspection process, and (3) information VA provides publicly on the quality of SVH care. As part of that work GAO analyzed VA data on expenditures for SVHs and interviewed VA officials. For this statement GAO reviewed expenditure and utilization data for fiscal year 2019. What GAO Recommends In its July 2019 report, GAO made three recommendations related to SVHs, including that VA require that all failures to meet quality standards are cited as deficiencies on SVH inspections. VA concurred with two recommendations and concurred in principle with the third. VA has addressed one recommendation and continued attention is needed to address the two remaining recommendations. For more information, contact Sharon M. Silas at (202) 512-7114 or silass@gao.gov. Wed, 29 Jul 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-632 What GAO Found Government-wide contract obligations in response to the COVID-19 pandemic totaled $17.8 billion as of June 11, 2020. Four agencies accounted for 85 percent of total COVID-19 contract obligations (see figure). This report provides available baseline data on COVID-19 federal contract obligations. Contract Obligations in Response to COVID-19 by Department, as of June 11, 2020 About 62 percent of federal contract obligations were for goods to treat COVID-19 patients and protect health care workers—including ventilators, gowns, and N95 respirators. Less than half of total contract obligations were identified as competed (see figure). Top Five Goods and Services and Percentage of Obligations Competed, as of June 11, 2020 Why GAO Did This Study According to the Centers for Disease Control and Prevention, as of June 30, 2020, the United States has documented more than 2.5 million confirmed cases and more than 125,000 deaths due to COVID-19. To facilitate the U.S. response to the pandemic, numerous federal agencies have awarded contracts for critical goods and services to support federal, state, and local response efforts. GAO's prior work on federal emergency response efforts has found that contracts play a key role, and that contracting during an emergency can present unique challenges as officials can face pressure to provide goods and services as quickly as possible. The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) included a provision for GAO to provide a comprehensive review of COVID-19 federal contracting. This is the first in a series of GAO reports on this issue. This report describes, among other objectives, key characteristics of federal contracting obligations awarded in response to the COVID-19 pandemic. Future GAO work will examine agencies' planning and management of contracts awarded in response to the pandemic, including agencies' use of contracting flexibilities provided by the CARES Act. GAO analyzed data from the Federal Procurement Data System-Next Generation on agencies' reported government-wide contract obligations for COVID-19 through June 11, 2020. GAO also analyzed contract obligations reported at the Departments of Health and Human Services, Defense, Homeland Security, and Veterans Affairs—the highest obligating agencies. For more information, contact Marie A. Mak at (202) 512-4841 or MakM@gao.gov. Wed, 29 Jul 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-572 What GAO Found The Food and Drug Administration (FDA) has regulated most over-the-counter (OTC) drugs—that is, drugs available without a prescription—through the OTC monograph process. FDA has described an OTC monograph as a "rulebook" for marketing safe and effective OTC drugs, such as aspirin, cough and cold medicine, and hand sanitizer. OTC monographs established conditions—such as active ingredients, indications for use, dosage forms, and product labeling—under which an OTC drug was generally recognized as safe and effective. According to FDA officials, before the CARES Act, which was enacted in March 2020, the agency's ability to update and finalize monographs in response to safety issues and to reflect new scientific information was limited by the rulemaking process the agency was required to follow, as well as insufficient resources. Agency officials estimated that it took at least 6 years to complete the required rulemaking process. Additionally, the agency reported it was critically under-resourced to regulate the estimated 100,000 OTC drugs marketed through the monograph process. However, the CARES Act provided for a new process to regulate these OTC drugs rather than the rulemaking process. FDA officials expect it will take less time to update and finalize requirements for OTC drugs using the new process. The CARES Act also authorized FDA to assess user fees to provide additional resources to regulate OTC drugs. Although FDA officials said this new process and user fees should improve its regulation of OTC drugs, the agency's analysis of the effect of the CARES Act is still ongoing. FDA officials told GAO that prior to the CARES Act, they used various methods to identify and respond to safety issues related to OTC drugs. For example, to identify these issues, FDA officials said they read medical literature related to safety issues and reviewed reports submitted to the agency's adverse event reporting system. To respond to these issues, FDA took steps such as issuing drug safety communications to consumers and requesting that manufacturers make changes to a drug's labeling. For example, in 2015, two FDA advisory committees recommended that cough and cold drugs with codeine be removed from the relevant OTC monograph for use in drugs in children. In 2018, FDA also issued a drug safety communication stating the risks outweighed the benefits for the use of these drugs in children. However, FDA officials said these methods were not a substitute for rulemaking because manufacturers could legally market their OTC drugs without making requested safety changes until the rulemaking process was completed. According to FDA officials, the new process for regulating OTC drugs included in the CARES Act could improve FDA's ability to address identified safety risks in a more timely and efficient manner in the future. The act established an expedited process to address safety issues that pose an imminent hazard to public health or to change a drug's labeling to mitigate a significant or unreasonable risk of a serious adverse event. Why GAO Did This Study OTC drugs prevent and treat a variety of conditions; for example, sunscreen is used to help prevent sunburn. FDA officials and stakeholders, such as industry representatives and patient and provider groups, have questioned whether the monograph process used to regulate most OTC drugs has been overly burdensome and has limited FDA's ability to quickly update and finalize monographs in response to potential safety issues for consumers. Enacted in March 2020, the CARES Act changed how FDA regulates OTC drugs. The Sunscreen Innovation Act included a provision for GAO to review FDA's regulation of OTC drugs. This report describes, among other issues, (1) the factors that affected FDA's ability to regulate OTC drugs and (2) how FDA identified and responded to safety issues associated with these drugs. GAO reviewed federal statutes and agency documents and interviewed FDA officials and stakeholders familiar with the monograph process. These stakeholders included representatives from the OTC drug industry, health care provider and consumer groups, and researchers. The Department of Health and Human Services provided technical comments on this report, which GAO incorporated as appropriate. For more information, contact John E. Dicken at (202) 512-7114 or dickenj@gao.gov. Wed, 29 Jul 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-553 What GAO Found The Department of Veterans Affairs' (VA) Veterans Health Administration (VHA) provides training to more than 45,000 medical and dental residents annually through its Graduate Medical Education (GME) program. VHA has established policy for its GME program that details many roles and responsibilities for overseeing VA medical facilities' reimbursements to affiliated academic institutions for residents' salaries and benefits. However, this policy does not define key roles and responsibilities for VHA's central office components, its regional networks, or its medical facilities. For example, VHA's regional networks do not have defined roles and responsibilities for overseeing GME disbursements—contributing to noninvolvement or inconsistent involvement in disbursement agreement oversight. VHA officials reported that they are in the process of updating disbursement agreement policy, but did not indicate if the updates would address all identified concerns. While VHA officials said that VHA's two disbursement agreement oversight mechanisms—facility periodic audits and the Resident Disbursement Audit Process (ReDPro) checklist—are meant to have distinct but complementary purposes, GAO found that VHA policy, guidance, and the tools distributed for these oversight mechanisms did not reflect the distinct purposes officials described. VHA officials said that periodic audits are intended to be a first level of defense and to review actual payments to affiliates, whereas the ReDPro checklist is intended to be a second level of defense, aimed at reviewing the process to see if the rules related to disbursement agreements are being followed by VA medical facilities. However, the ReDPro checklist tool and VHA's recommended periodic audit tool have numerous areas of overlap, including duplicative questions. This overlap causes inefficiencies and unnecessary burden on VA medical facility staff. GAO also found additional weaknesses in the tools, guidance, and training for the two oversight mechanisms. For example, GAO found an unclear ReDPro checklist tool, along with insufficient guidance and training related to conducting the ReDPro reviews. Officials from eight of 13 facilities in GAO's review indicated that the ReDPro checklist instructions were unclear regarding appropriate supporting documents for checklist responses. These weaknesses contributed to errors and inconsistencies in ReDPro responses. the lack of a standard audit tool, and inadequate guidance and training for periodic audit teams that contributed to problematic inconsistencies in the methodologies used by the audit teams and deficiencies in some of the audits conducted. Officials from 10 of 13 facilities in GAO's review indicated that they would benefit from more tools, guidance, or training related to conducting periodic audits. These weaknesses limit the effectiveness of VHA's oversight mechanisms, and put VHA at increased risk of both not being able to identify and correct facilities' lack of adherence to disbursement agreement policy and of possible improper payments to GME affiliates. Why GAO Did This Study Under VHA's GME program, VA medical facilities use disbursement agreements to reimburse affiliated academic institutions for residents' salaries and benefits. VHA developed policy related to establishing and administering disbursement agreements, but audits have found that facilities have not always adhered to VHA policy—resulting in improper payments to affiliates. GAO was asked to review VHA policies and procedures related to reimbursements to affiliates for GME. This report examines (1) oversight roles and responsibilities for GME disbursement agreements and (2) VHA's mechanisms for ensuring VA medical facilities adhere to policy. GAO reviewed relevant VHA documents and federal internal control standards and interviewed VHA officials. GAO also reviewed ReDPro checklist responses and documentation from 13 VA medical facilities—selected based on factors including geographic variation, GME program size, and number of affiliates. GAO also visited four of the 13 facilities and interviewed officials at the other nine facilities. What GAO Recommends GAO is making seven recommendations to VA to define key roles in policy, reduce overlap between the ReDPro checklist and facility periodic audits, and improve the oversight mechanisms' tools, guidance, and training. VA concurred with GAO's recommendations. For more information, contact Sharon M. Silas at (202) 512-7114 or silass@gao.gov. Fri, 17 Jul 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-680T What GAO Found As of May 2020, U.S. Customs and Border Protection (CBP) within the Department of Homeland Security (DHS) had obligated nearly $87 million of the approximately $112 million it received specifically for consumables and medical care in a 2019 emergency supplemental appropriations act (2019 Emergency Supplemental). CBP obligated some of these funds for consumable goods and services, like food and hygiene products, as well as medical care goods and services, such as defibrillators, masks, and gloves. However, CBP obligated some of these funds for other purposes in violation of appropriations law. For example, CBP obligated some of these funds for goods and services for its canine program; equipment for facility operations like printers and speakers; transportation items that did not have a primary purpose of medical care; and upgrades to computer networks used for border enforcement activities. GAO identified two factors that contributed to CBP's appropriation law violations—insufficient guidance to CBP offices and components before obligations were made, and a lack of oversight roles and responsibilities for reviewing obligations once made. After the 2019 Emergency Supplemental was enacted, CBP did not provide sufficient guidance explaining how offices and components could obligate funds for consumables and medical care and, as a result, some offices and components may not have understood that there were limitations on how they could use those funds. For example, officials from one CBP component stated they believed they could use the consumables and medical care funds for any goods or services they considered to be in the interest of individuals in custody or that would help ensure the efficient processing of individuals. Additionally, while CBP offices and components took some steps to oversee obligations from the 2019 Emergency Supplemental funds, GAO identified gaps in CBP's roles and responsibilities for reviewing obligations to ensure they were consistent with the intended purpose of the funds. CBP took various steps to enhance medical care and services for individuals in its custody, including, among other things, increasing its use of contracted medical providers, issuing new health screening policies, and requesting the Centers for Disease Control and Prevention to assess conditions and make recommendations for the reduction of influenza in its facilities. In particular, in January 2019 CBP issued an interim directive which, among other things, required health interviews and medical assessments for certain individuals in its custody. CBP updated this directive in December 2019 and issued corresponding implementation plans in March 2020. GAO also identified gaps related to CBP's implementation and oversight of its medical care efforts. For example: CBP had not consistently implemented enhanced medical care policies and procedures at southwest border facilities. Through facility visits and analysis of data, GAO found that some locations were not consistently conducting health interviews and medical assessments, as required by the medical directives; and CBP decided not to implement a recommendation from the Centers for Disease Control and Prevention to offer influenza vaccines to individuals in custody but did not document how it had arrived at this decision. CBP documentation stated that vaccinating apprehended individuals would pose operational, medical, legal, and logistical challenges. CBP officials stated that they made this decision in consultation with others in the Department of Homeland Security and that this group continues to meet on public health issues and will use such meetings to reassess whether to offer influenza vaccines. Finally, from fiscal year 2015 through fiscal year 2019, CBP was directed to report on deaths of individuals in its custody to Congress. Additionally, in fiscal year 2014, DHS was directed to provide information on deaths in custody in summary statistics to Congress. GAO’s review of CBP documentation and reports to Congress showed that 31 individuals died in custody along the southwest border from fiscal years 2014 through 2019, but CBP documented 20 deaths in its reports. Why GAO Did This Study Three children died in CBP custody between December 2018 and May 2019, prompting questions about CBP's medical care for those in its custody. In July 2019, an emergency supplemental appropriations act was enacted, providing additional funds to CBP, including funds for consumables and medical care. This testimony summarizes key information contained in GAO's July 2020 report, entitled Southwest Border: CBP Needs to Increase Oversight of Funds, Medical Care, and Reporting of Deaths (GAO-20-536). What GAO Recommends In the report upon which this testimony is based, GAO made 10 recommendations to CBP, including providing additional guidance and oversight of appropriated funds; developing and implementing oversight mechanisms related to medical care policies; documenting decisions made regarding offering the influenza vaccine; and providing guidance to ensure that deaths in custody are reported to Congress, as directed. DHS concurred with all 10 recommendations. For more information, contact Rebecca Gambler at (202) 512-8777 or gamblerr@gao.gov, or Mary Denigan-Macauley at (202) 512-7114 or deniganmacauleym@gao.gov. Wed, 15 Jul 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-571R What GAO Found GAO provides a primer describing the most common types of arrangements used by states to finance the nonfederal share of state's Medicaid expenditures. The primer provides examples of how these arrangements can shift the magnitude or share of expenditures to local governments, providers, and the federal government. Federal law imposes requirements around the use of provider and local government funds to finance the nonfederal share of a state's Medicaid expenditures, but in some cases, the nonfederal share of a particular Medicaid payment can be financed entirely by local government or by using funding from taxes levied on providers with no contribution from state general funds. In these cases, the arrangement can shift responsibility for financing Medicaid expenditures to local governments, providers, and the federal government. For example, if a state finances the nonfederal share using local government funds (e.g. funds from a county-run hospital) the arrangement shifts the financing to the federal government because the net payment—the payment minus any funds contributed by the provider— the hospital receives consists entirely of federal funds. Example of a Medicaid Payment Financed by Local Government and Federal Funds Why GAO Did This Study The federal government and states share responsibility for financing Medicaid expenditures. The Centers for Medicare & Medicaid Services (CMS), the agency within the Department of Health and Human Services (HHS), which oversees Medicaid, matches each state's Medicaid expenditures for health care services with federal funds according to a statutory formula. These expenditures include payments for care provided to Medicaid beneficiaries, such as base payments directly to providers for services rendered, and supplemental payments, which are not tied to care for individual beneficiaries, but may help offset any remaining costs of care for Medicaid beneficiaries. Federal law requires that states finance at least 40 percent of their share of total Medicaid expenditures through state funds; within limits, they can use funding from local governments or funding from taxes levied on providers. The arrangements states use to finance the nonfederal share of Medicaid expenditures have implications for federal spending. For example, GAO found in past work that states rely heavily on local government and provider funds to finance supplemental payments, sometimes in ways that lowered their own expenditures by shifting a larger share of the payments to the federal government. GAO was asked to provide information on different arrangements states have used to finance the nonfederal share of Medicaid expenditures. In this report, GAO provides a primer on this topic, describing these financing arrangements, and provides examples of how these arrangements have shifted the magnitude or share of expenditures to local governments, providers, and the federal government. GAO was asked to provide information on different arrangements states have used to finance the nonfederal share of Medicaid expenditures. In this report, GAO provides a primer on this topic, describing these financing arrangements, and provides examples of how these arrangements have shifted the magnitude or share of expenditures to local governments, providers, and the federal government. To do so, GAO reviewed related GAO reports and other research published since 2012 that examined the arrangements most commonly used by states, as well as relevant federal laws, regulations, and guidance. Using that information, GAO produced illustrations of the financing arrangements and described their implications. GAO provided a draft of this report to HHS for review and comment. HHS provided technical comments, which GAOs incorporated as appropriate. What GAO Recommends Since designating Medicaid as a high-risk area in 2003, GAO has made at least 55 recommendations related to the appropriate use of program dollars. Of these recommendations, 15 were not yet implemented as of May 2020. For more information, contact Carolyn L. Yocom at (202) 512-7114 or yocomc@gao.gov. Tue, 14 Jul 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-536 What GAO Found As of May 2020, U.S. Customs and Border Protection (CBP) within the Department of Homeland Security (DHS) had obligated nearly $87 million of the approximately $112 million it received specifically for consumables and medical care in a 2019 emergency supplemental appropriations act. CBP obligated some of these funds for consumable goods and services, like food and hygiene products, as well as medical care goods and services such as defibrillators, masks, and gloves. However, CBP obligated some of these funds for other purposes in violation of appropriations law. For example, CBP obligated some of these funds for goods and services for its canine program; equipment for facility operations like printers and speakers; transportation items that did not have a primary purpose of medical care like motorcycles and dirt bikes; and facility upgrades and services like sewer system upgrades. GAO identified two factors that contributed to CBP's violations—insufficient guidance to CBP offices and components before obligations were made, and a lack of oversight roles and responsibilities for reviewing obligations once made. After the 2019 emergency supplemental was enacted, CBP did not provide sufficient guidance explaining how offices and components could obligate funds for consumables and medical care and, as a result, some offices and components may not have understood that there were limitations on how they could use those funds. For example, officials from one CBP component stated they believed they could use the consumables and medical care funds for any goods or services they considered to be in the interest of individuals in custody or that would help ensure the efficient processing of individuals. Once obligations were made, CBP did not provide oversight across its offices and components, such as by reviewing obligations, to ensure the obligations were consistent with the purpose of the funds. Until CBP develops and implements additional guidance, and establishes oversight roles and responsibilities, the agency does not have assurance that the remainder of funds appropriated for consumables and medical care—about $25 million as of May 2020—will be obligated consistent with the purpose of the funds. CBP took various steps to enhance medical care and services for individuals in its custody, including, among other things, increasing its use of contracted medical providers (see figure on the next page), issuing new health screening policies, and requesting the Centers for Disease Control and Prevention assess conditions and make recommendations for the reduction of influenza in its facilities. In particular, in January 2019 CBP issued an interim directive which, among other things, required health interviews and medical assessments for certain individuals in its custody. CBP updated this directive in December 2019 and issued corresponding implementation plans in March 2020. Contracted Medical Provider Office at a U.S. Customs and Border Protection Facility GAO identified gaps related to CBPs implementation and oversight of its medical care efforts. For example: CBP has not consistently implemented enhanced medical care policies and procedures at southwest border facilities. Through facility visits and analysis of data, GAO found that some locations were not consistently conducting health interviews and medical assessments, as required by the medical directives. Further, while CBP's implementation plans call for oversight of medical efforts, such as metrics to assess compliance, the plans do not include some elements necessary for effective oversight, such as performance targets and roles and responsibilities for corrective actions. Until CBP develops and implements oversight mechanisms that include targets, roles, and responsibilities, the agency is not well-positioned to ensure consistent implementation of medical efforts. CBP decided not to implement a recommendation from the Centers for Disease Control and Prevention to offer influenza vaccines to individuals in custody, but did not document how it arrived at this decision. CBP officials stated that vaccinating apprehended individuals for influenza would pose operational, medical, legal, and logistical challenges. CBP officials stated they made this decision in consultation with others in the Department of Homeland Security, and this group continues to meet on public health issues, and will use such meetings to reassess whether to offer influenza vaccines. Documenting what information it uses in reassessing this decision, such as how it weighs the costs and benefits, would help provide CBP, Congress, and the public assurance that the agency has taken all relevant factors into account. CBP does not have reliable information on deaths, serious injuries, and suicide attempts and has not consistently reported deaths of individuals in custody to Congress. CBP officials attributed this to several reasons, including that CBP's directive on significant incident reporting does not include a definition of suicide attempts and its automated reporting system does not have categories specific to serious injuries or suicide attempts. Instead, these incidents are classified together with less serious incidents and included as general “injuries or illnesses” in reports to senior leadership. Without additional field guidance and updates to its reporting system, CBP will continue to lack reliable information on the number of incidents that occur in its custody. Further, from fiscal year 2014 through fiscal year 2019, CBP was directed to report on deaths of individuals in its custody to Congress. GAO's review of CBP documentation and reports to Congress showed that 31 individuals died in custody along the southwest border from fiscal years 2014 through 2019, but CBP documented only 20 deaths in its reports. Ensuring that deaths in custody are reported to Congress and documented appropriately would help CBP improve transparency with Congress. Why GAO Did This Study Three children died in CBP custody between December 2018 and May 2019, prompting questions about CBP's medical care for those in its custody. In July 2019, an emergency supplemental appropriations act was enacted, providing additional funds to CBP, including funds for consumables and medical care. GAO was asked to review CBP's medical efforts for individuals in its custody along the southwest border. This report examines (1) the extent to which CBP obligated and oversaw funds for consumables and medical care, (2) steps CBP took to enhance medical care, (3) the extent to which CBP implemented and oversaw its medical care efforts, and (4) the extent to which CBP has reliable information on, and reported, deaths, serious injuries, and suicide attempts of individuals in custody. To conduct this audit GAO reviewed CBP documentation, including financial reports; directives, policies, and training related to screening individuals for medical issues; and directives and policy documentation on reporting deaths in custody. GAO interviewed CBP officials in headquarters and two field locations, and observed medical efforts in facilities in field locations, selected on the basis of volume of apprehensions. What GAO Recommends GAO is making 10 recommendations to CBP, including to: develop and implement additional guidance for ensuring supplemental funds are obligated consistent with their purposes; establish oversight roles and responsibilities to ensure supplemental funds are obligated consistent with their purposes; develop and implement oversight mechanisms for CBP's policies and procedures relating to medical care for individuals in its custody, to include performance targets and roles and responsibilities for taking corrective action, among other things; document what information it is using to assess whether to offer the influenza vaccine to individuals in custody; provide additional guidance to field personnel to ensure they classify reports on deaths, serious injuries, and suicide attempts in accordance with CBP policy; update its internal reporting system to include categories on serious injuries and suicide attempts; and ensure reliable information on deaths in custody is reported to Congress and appropriate documentation on such reporting is maintained. DHS concurred with all 10 recommendations. For more information, contact Rebecca Gambler at (202) 512-8777 or gamblerr@gao.gov, or Mary Denigan-Macauley at (202) 512-7114 or deniganmacauleym@gao.gov. Tue, 14 Jul 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-646SP Why This Matters Increasing the immunity of a population to an infectious disease like COVID-19 can slow the spread of infection and protect those most vulnerable. However, with limited information about important aspects of COVID-19, there are challenges to understanding the implications of herd immunity in the current pandemic. The Science What is it? A population can establish herd immunity to an infectious disease once a large enough portion of the population—typically 70 to 90 percent—develops immunity. Reaching this "herd immunity threshold" limits the likelihood that a non-immune person will be infected. In general, immunity develops through either infection (resulting in natural immunity) or vaccination (resulting in vaccine-induced immunity). Herd immunity helps protect people not immune to a disease by reducing their chances of interacting with an infected individual. This process slows or stops the spread of the disease.   Figure 1. Herd immunity helps reduce the likelihood of disease transmission from infected individuals to non-immune individuals. How does it work? Once a community has established herd immunity, someone without immunity is less likely to be exposed to an infectious individual during an outbreak. For example, because there are more people with immunity in the population, there are fewer people susceptible to infection, and thus the number of potential transmissions is limited. Similarly, those who are immune will not be infected, and thus will not transmit the disease to others. Both of these situations help limit the size of the outbreak. If an effective vaccine is available for a virus, achieving herd immunity can require a high rate of vaccination in the community. For diseases that spread more easily, more people must have vaccine-induced or natural immunity to achieve herd immunity. However, if a virus mutates quickly, the community's herd immunity may be relatively short-lived because the immunity from prior infection or vaccination may no longer be effective. Also, the disease can still circulate in segments of the population that are not immune, such as those with weakened immune systems who cannot effectively form immunity. For diseases where no vaccination is available, it is possible to develop herd immunity through exposure to, and recovery from, the disease. However, if COVID-19 runs its natural course, this approach would entail the risk of severe disease or death. Given the risk associated with COVID-19 infections, achieving herd immunity without a vaccine could result in significant morbidity and mortality rates. How mature is it? Knowledge of previous infectious disease outbreaks where a vaccine was available has allowed researchers to identify how herd immunity was achieved for those diseases. However, researchers currently have insufficient data on the factors that could contribute to herd immunity for the COVID-19 pandemic. These factors include the herd immunity threshold, the number of secondary cases typically generated by an infected individual, the viral mutation rate, and the length of time immunity lasts. At this stage in the COVID-19 pandemic, researchers have insufficient data to draw definitive conclusions about the level of immunity conferred by an infection, or how long immunity to the disease might last. For example, in order to determine the herd immunity threshold, it is important to know how contagious the disease is–which is affected by factors such as how many susceptible people an infected person can infect. While researchers have developed estimates for how contagious COVID-19 is, uncertainties about case reporting and testing—such as uncertainty in the accuracy of some tests—make this calculation difficult. Some peer-reviewed research on COVID-19 suggests the average number of people infected by a contagious person ranges from about one to seven. Figure 2. While data on previous disease outbreaks are available, for COVID-19, we don’t yet have all of the necessary data for many of the relevant factors. While analyses of viruses related to the novel coronavirus have shown that infection can provide some level of immunity, such immunity did not appear to last longer than a year. Studies of other infectious diseases, such as polio, exhibit a range in the threshold for herd immunity, the average number of people infected by an infected person, and how long people remained immune, among other factors. Opportunities Halt disease spread. Achieving herd immunity will slow or stop the spread of a disease within a population and limit the size of outbreaks. Support economic recovery. Established herd immunity could help bolster the economy by allowing people to safely return to work and conduct other activities. Restore medical capacity. Established herd immunity could help ease the burden on the medical system as fewer patients seek treatment. Challenges Limited data on immunity. Currently, there are a number of unknown factors, such as whether a COVID-19 infection leads to immunity and how long immunity might last. It may be necessary for more time to pass to monitor individuals who have been infected and recovered and thus determine how long they show disease immunity. This information is needed to determine the herd immunity threshold. Implications of natural herd immunity. Relying on natural immunity from the disease progression of COVID-19 could allow a population to establish herd immunity. However, such an approach risks exposing people to a debilitating and potentially fatal disease. Testing limitations. If infection confers immunity, researchers need accurate data on the number of recovered individuals and other disease transmission parameters to determine if or when herd immunity is achieved. Accurate testing data are critical to understanding these parameters. However, there are still challenges associated with the use and availability of antibody tests, as well as with determining their accuracy. Lack of vaccine. A vaccine could help a population safely achieve herd immunity. However, developing a vaccine is a complicated process that is costly, typically requires 10 to 15 years or more, and many candidates fail during the development process. Efforts are underway, however, to accelerate the process for COVID-19. Inconsistent immunity. Even if herd immunity is eventually achieved, outbreaks may still occur because immunity may not be uniform across the general population. Policy Context and Questions What studies are needed to gather data on the parameters for herd immunity against COVID-19, and how can this be reflected in resource priorities? If a COVID-19 vaccine is approved but the number of available doses is still limited, what factors may need to be considered in deciding who should be vaccinated first? If the path to COVID-19 herd immunity is uncertain, what steps might be needed to help strike a balance between public health and enabling the economy and society to function smoothly? How could infectious disease modeling assist in working towards establishing herd immunity? For more information, contact Karen Howard at (202) 512-6888 or HowardK@gao.gov. Tue, 07 Jul 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-610SP Why This Matters With millions of teens and young adults using e-cigarettes, a new generation could become addicted to nicotine and face other health risks. For some adult smokers, e-cigarettes may offer a less harmful substitute for traditional cigarettes. However, long-term effects on users, second-hand exposure, and environmental effects are not yet fully known. The Technology What is it? Electronic cigarettes—or e-cigarettes—are battery-powered devices that convert a liquid, usually with nicotine, into an inhalable aerosol. They are designed as an alternative to smoking traditional cigarettes. First introduced in the United States about 15 years ago, e-cigarettes have evolved from disposable, single-use products to more sophisticated devices that can be refilled and customized (fig. 1). Figure 1. E-cigarettes can vary widely in design and appearance. E-cigarettes are popular among teens and young adults, according to the Centers for Disease Control and Prevention (CDC). In 2019, nearly 28 percent of high-school students and 11 percent of middle-school students reported using e-cigarettes. About 8 percent of young adults ages 18 to 24 reported using e-cigarettes in 2018. How does it work? Although e-cigarettes vary in design and appearance, they generally work the same way. An e-cigarette has four components: battery, cartridge or tank that holds a liquid, heating element or atomizer, and mouthpiece. Studies have identified a wide variety of chemicals in the cartridges, liquids, and aerosols, including between 60 and 113 ingredients in different liquid brands. According to CDC, the aerosol from the liquid generally contains fewer harmful chemicals than smoke from traditional cigarettes. However, risks of injury and death from e-cigarettes are becoming more apparent, and the toxicity of some ingredients in inhaled form is largely unknown. The liquid typically contains water and other solvents, nicotine, flavoring, and other substances. The liquid can also contain tetrahydrocannabinol (THC), the main psychoactive chemical in marijuana. The aerosol can contain metals, volatile organic compounds, and formaldehyde, which is a known carcinogen. The device heats the liquid, creating an aerosol. Inhalation, commonly called vaping, deposits particles in the user’s lungs (fig. 2). Substances in the particles, including nicotine, pass into the blood. Nicotine flows rapidly into the brain, resulting in the release of dopamine, which is associated with pleasure and appetite suppression. Nicotine can cause addiction. E-cigarettes mimic the sensory experiences of smoking a traditional cigarette, such as inhaling, exhaling, and the hand-to-mouth motion. These have been found to contribute to addiction by creating additional pleasurable sensations through the taste, sight, and smell. Figure 2. Substances from inhaled aerosol particles reaching the e-cigarette user’s lungs, blood, and brain. Nicotine exposure during adolescence can affect learning, memory, and attention. It can also increase risk for future addiction to nicotine and other drugs. However, many young users report they began using e-cigarettes because of the flavors and, according to CDC, do not realize they are inhaling nicotine. How mature is it? E-cigarettes are relatively new. Therefore, direct and indirect health effects are not yet fully known, including long-term effects on users (e.g., increase or reduction in smoking), second-hand exposure to exhaled aerosol and accidental ingestion of the liquid, and environmental effects (e.g., lack of recycling and waste streams for used devices). In addition to the risk of nicotine addiction, e-cigarette use is associated with serious lung injury. As of February 2020, e-cigarette lung injury resulted in over 2,700 hospitalizations, mostly among young adults, and 68 deaths in the United States. Public health agencies found these cases are strongly linked to vitamin E acetate, an additive in some THC-containing e-cigarettes, but have not ruled out the possible contribution of other chemicals. The Food and Drug Administration (FDA) extended its regulatory authority over tobacco products to include e-cigarettes in May 2016. In December 2019, Congress raised the minimum age to buy tobacco products, including e-cigarettes, from 18 to 21. Because of the popularity of certain flavored e-cigarette products among children, FDA stated in January 2020 that it would prioritize enforcement actions against the manufacture and sale of most flavors in cartridge-based e-cigarettes. In April 2020, FDA extended from May to September 2020 the deadline for manufacturers to apply for premarket authorization, a process that includes the scientific evaluation of risks and benefits of e-cigarettes for the U.S. population. Opportunities Possible reduction in smoking. E-cigarette use may offer opportunities to reduce the known long-term health effects of smoking traditional cigarettes, such as cancer and heart disease. According to CDC, e-cigarettes may benefit adult smokers who are not pregnant if used as a substitute for, not a complement to, traditional cigarettes. However, their long-term health effects and efficacy as tobacco cessation devices are not yet clear, and FDA has not approved e-cigarettes for tobacco cessation. Challenges Increased nicotine addiction. For younger users, e-cigarettes may lead to smoking, according to a 2018 study by the National Academies of Sciences, Engineering, and Medicine. This outcome could erase decades of progress in reducing smoking, the leading cause of preventable death in the United States and globally Toxicity of inhaled chemicals. The toxicity of some inhaled additives is unknown because they had not previously been used for inhalation. This includes additives considered safe for ingestion in food or drink. For example, it is known that one butter-flavor additive (diacetyl) used in e-cigarettes caused serious lung injury and death when inhaled by workers at a popcorn factory. Varying hazards due to lack of standardization. Differences in design and engineering influence the concentrations of chemicals in the liquid and aerosol. This likely has implications for the e-cigarettes' health impact on users exposed to inhaled aerosol and non-users exposed to exhaled aerosol or to the liquid. Effect on indoor and outdoor environments. E-cigarettes increase concentrations of nicotine, particulate matter, and other potentially toxic substances in indoor environments. The devices' lithium-ion batteries and trace amounts of hazardous chemicals make disposal and recycling difficult. Possible impact on COVID-19 patients. Some public health officials have cautioned that because the virus that causes COVID-19 affects the respiratory tract, e-cigarette users and smokers could be at higher risk of COVID-19 complications. This is a new area of research Policy Context and Questions What are the health and environmental effects of e-cigarettes? What information and data could help policymakers better understand the risks and potential benefits of e-cigarettes compared to traditional cigarettes? What additional approaches might help discourage young people from using e-cigarettes? For example, how might federal and state taxes affect use? How can e-cigarettes be made safer to reduce second-hand exposure? For more information, contact Karen Howard at (202) 512-6888 or HowardK@gao.gov. Tue, 30 Jun 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-659T What GAO Found In response to the national public health and economic threats caused by COVID-19, four relief laws were enacted as of June 2020 that appropriated $2.6 trillion. This funding provided support to individuals, health care providers, businesses, and state and local government. While complete government-wide data will not be available until July, GAO determined that as of May 31, 2020, a total of about $1.2 trillion of assistance has been provided—close to $700 billion in expenditures and over $500 billion in loan guarantees. Consistent with the urgency of responding to widespread health issues and economic disruptions, agencies have worked hard to give priority to moving swiftly. In moving quickly, however, agencies made trade-offs; thus, only limited progress has been made so far in achieving transparency and accountability goals. GAO also identified challenges with the federal response to the crisis, including: Paycheck Protection Program (PPP). The Small Business Administration (SBA) moved quickly to establish a new nationwide program, but the pace contributed to confusion and questions and raised program integrity concerns. GAO recommends that SBA develop and implement plans to identify and respond to risks in PPP to better ensure program integrity. SBA neither agreed nor disagreed. Implementing GAO’s recommendation is essential. Economic impact payments. The Internal Revenue Service (IRS) and the Department of the Treasury (Treasury) faced difficulties delivering payments to some individuals, and made some payments to ineligible individuals, such as decedents. GAO recommends that IRS should consider cost-effective options for notifying ineligible recipients how to return payments. IRS agreed. Unemployment Insurance (UI). The program could have an unintentional overlap with benefits provided under PPP. GAO recommends that the Department of Labor (DOL) immediately provide help to state unemployment agencies that specifically addresses PPP loans, and the risk of improper payments associated with these loans. DOL is planning additional guidance. Aviation-preparedness plan. In 2015, GAO recommended that the Department of Transportation (DOT) work with federal partners to develop a national aviation-preparedness plan for communicable disease outbreaks. Thus far, no plan exists. GAO recommends Congress require DOT to produce a plan. Full access to death data. It is important to consistently use safeguards when providing assistance to individuals. The Treasury and Bureau of Fiscal Service do not have access to the Social Security Administration’s full set of death records. GAO recommends that the Congress give Treasury that access and require that Treasury consistently use it. Medicaid. GAO previously found that during economic downturns, the Federal Medical Assistance Percentage (FMAP) formula does not reflect current state economic conditions. GAO recommends that, during an economic downturn, Congress use a formula to provide timely and targeted assistance during economic downturns. Why GAO Did This Study The outbreak of COVID-19 quickly spread around the globe. As of June 17, 2020, the United States had over 2 million reported cases of COVID-19, and over 100,000 reported deaths, according to federal agencies. Parts of the nation have seen severely strained health care systems. The country has also experienced a significant and rapid downturn in the economy. Four relief laws, including the CARES Act, were enacted as of June 2020 to provide appropriations to address the public health and economic threats posed by COVID-19. In addition, the administration created the White House Coronavirus Task Force. The CARES Act includes a provision for GAO to report regularly on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. Yesterday, GAO issued its first report (GAO-20-625). Like the report, this testimony focuses on key actions the federal government has taken to address the COVID-19 pandemic, GAO recommendations for improvement, and evolving lessons learned relevant to the nation’s response to pandemics, among other things. GAO reviewed data and documents from federal agencies about their activities and interviewed federal and state officials as well as industry representatives. GAO also reviewed available economic, health, and budgetary data. What GAO Recommends In the report, GAO makes three new recommendations for agencies and three matters for consideration for Congress that address these issues. For more information, contact A. Nicole Clowers, (202) 512-7114 or clowersa@gao.gov. Fri, 26 Jun 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-625 What GAO Found In response to the national public health and economic threats caused by COVID-19, four relief laws were enacted as of June 2020, including the CARES Act, in March 2020. These laws have appropriated $2.6 trillion across the government. Six areas—Paycheck Protection Program (PPP); Economic Stabilization and Assistance to Distressed Sectors; unemployment insurance; economic impact payments; Public Health and Social Services Emergency Fund; and Coronavirus Relief Fund—account for 86 percent of the appropriations (see figure). Appropriations for COVID-19 Response from COVID-19 Relief Laws Enacted as of May 31, 2020 Note: COVID-19 relief laws enacted as of May 31, 2020 include the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, Pub. L. No. 116-123, 134 Stat. 146; Families First Coronavirus Response Act, Pub. L. No. 116-127, 134 Stat. 178 (2020); CARES Act, Pub. L. No. 116-136, 134 Stat. 281 (2020); and Paycheck Protection Program and Health Care Enhancement Act, Pub. L. No. 116-139, 134 Stat. 620 (2020). These amounts represent appropriation warrants issued as of May 31, 2020, by the Department of the Treasury to agencies in response to appropriations made by COVID-19 relief laws. A warrant is an official document issued upon enactment of an appropriation that establishes the amount of money authorized to be withdrawn from the Treasury. These amounts could increase in the future for programs with indefinite appropriations. In addition, this figure does not represent transfers of funds that agencies may make between accounts or transfers of funds they may make to other agencies, to the extent authorized by law. Total federal spending data are not readily available because, under Office of Management and Budget guidance, federal agencies are not directed to report COVID-19 related obligations (financial commitments) and expenditures until July 2020. It is unfortunate that the public will have waited more than 4 months since the enactment of the CARES Act for access to comprehensive obligation and expenditure information about the programs funded through these relief laws. In the absence of comprehensive data, GAO collected obligation and expenditure data from agencies, to the extent practicable, as of May 31, 2020.  For the six largest spending areas, GAO found obligations totaled $1.3 trillion and expenditures totaled $643 billion. The majority of the difference was due to the PPP, for which the Small Business Administration (SBA) obligated $521 billion. The amounts for loan guarantees will not be considered expenditures until the loans are forgiven, and for those that are not forgiven, whether they are timely repaid. GAO also collected expenditure data on other programs affected by the federal response. For example, GAO also found that the Department of Health and Human Services (HHS) has provided $7 billion in COVID-19 Medicaid funding related to a temporary increase in the Federal Medical Assistance Percentage (FMAP), the statutory formula the federal government uses to match states' Medicaid spending. Based on the information GAO collected, government-wide spending totals at least $677 billion, as of May 31, 2020. Given the sweeping and unfolding public health and economic crisis, agencies from across the federal government were called on for immediate assistance, requiring an unprecedented level of dedication and agility among the federal workforce, including those serving on the front lines to quickly establish services for those infected with the virus. Consistent with the urgency of responding to serious and widespread health issues and economic disruptions, agencies have given priority to moving swiftly where possible to distribute funds and implement new programs. As tradeoffs were made, however, agencies have made only limited progress so far in achieving transparency and accountability goals. GAO has identified several challenges related to the federal response to the crisis, as well as recommendations to help address these challenges, including the following: Viral testing. The Centers for Disease Control and Prevention (CDC) reported incomplete and inconsistent data from state and jurisdictional health departments on the amount of viral testing occurring nationwide, making it more difficult to track and know the number of infections, mitigate their effects, and inform decisions on reopening communities. However, HHS issued guidance on June 4, 2020, to laboratories that identifies required data elements to collect and how to report it to CDC. GAO will continue to examine activities related to COVID-19 testing. Distribution of supplies. The nationwide need for critical supplies to respond to COVID-19 quickly exceeded the quantity of supplies contained in the Strategic National Stockpile, which is designed to supplement state and local supplies during public health emergencies. HHS has worked with the Federal Emergency Management Agency (FEMA) and the Department of Defense (DOD) to increase the availability of supplies. However, federal, state, and local officials have expressed concerns about the distribution, acquisition, and adequacy of supplies. GAO will continue to examine these issues as well as the administration's efforts to mitigate supply gaps. Paycheck Protection Program. As of June 12, 2020, the Small Business Administration (SBA) had rapidly processed over $512 billion in 4.6 million guaranteed loans through private lenders to small businesses and other organizations adversely affected by COVID-19. The $512 billion represents loan obligations for SBA and does not include lender fees. As of May 31, 2020, SBA had expended about $2 billion in lender fees. SBA moved quickly to establish a new nationwide program, but the pace contributed to confusion and questions about the program and raised program integrity concerns. First, borrowers and lenders raised a number of questions about the program and eligibility criteria. To address these concerns, SBA and the Department of the Treasury (Treasury) issued a number of interim final rules and several versions of responses to frequently asked questions (see figure). However, questions and confusion remained. The Paycheck Protection Program Flexibility Act of 2020, enacted in June 2020, modified key program components. Second, to help quickly disburse funds, SBA allowed lenders to rely on borrower certifications to determine borrowers' eligibility, raising the potential for fraud. GAO recommends 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 its recommendation is essential. Timeline for Paycheck Protection Program, as of June 12, 2020 Economic impact payments. The Internal Revenue Service (IRS) and the Treasury moved quickly to disburse 160.4 million payments worth $269 billion. The agencies faced difficulties delivering payments to some individuals, and faced additional risks related to making improper payments to ineligible individuals, such as decedents, and fraud. For example, according to the Treasury Inspector General for Tax Administration, as of April 30, almost 1.1 million payments totaling nearly $1.4 billion had gone to decedents. GAO recommends that IRS should consider cost-effective options for notifying ineligible recipients how to return payments. IRS agreed with the recommendation. Unemployment Insurance (UI). States are implementing three new, federally funded UI programs created by the CARES Act and, as of May 2020, states have received more than 42 million UI claims. The Department of Labor (DOL) has taken steps to help states manage demand, but DOL is developing its approach to overseeing the new UI programs. GAO will be evaluating DOL's monitoring efforts in future reports. Further, the UI program is generally intended to provide benefits to individuals who have lost their jobs; under PPP, employers are generally required to retain or rehire employees for full loan forgiveness. According to DOL, no mechanism currently exists that could capture information in real time about UI claimants who may receive wages paid from PPP loan proceeds. GAO recommends that DOL, in consultation with SBA and Treasury, immediately provide help to state unemployment agencies that specifically addresses PPP loans, and the risk of improper payments associated with these loans. DOL neither agreed nor disagreed with the recommendation, but noted it was planning forthcoming guidance. Contract obligations. Government-wide contract obligations in response to the COVID-19 pandemic totaled about $17 billion as of May 31, 2020. Goods procured include ventilators; services contracted for include vaccine development. In addition, the CARES Act provided $1 billion for Defense Production Act (DPA) purchases—$76 million of which, for example, was awarded to increase production of N95 respirators. GAO recommends Congress consider taking legislative action in the following areas: Aviation-preparedness plan. In 2015, GAO recommended that the Department of Transportation (DOT) work with federal partners to develop a national aviation-preparedness plan for communicable disease outbreaks. DOT agreed, but as of May 2020, maintains that HHS and DHS should lead the effort. Thus far, no plan exists. GAO recommends Congress take legislative action to require DOT to work with relevant agencies and stakeholders to develop a national aviation-preparedness plan to ensure safeguards are in place to limit the spread of communicable disease threats from abroad while at the same time minimizing any unnecessary interference with travel and trade. Full access to death data. The number of economic impact payments going to decedents highlights the importance of consistently using key safeguards in providing government assistance to individuals. IRS has access to the Social Security Administration's full set of death records, but Treasury and its Bureau of the Fiscal Service, which distribute payments, do not. GAO recommends that Congress provide Treasury with access to the Social Security Administration's full set of death records, and require that Treasury consistently use it, to help reduce similar types of improper payments. Medicaid. GAO previously found that during economic downturns—when Medicaid enrollment can rise and state economies weaken—the FMAP formula does not reflect current state economic conditions. GAO previously developed a formula that offers an option for providing temporary automatic, timely, and targeted assistance. GAO recommends Congress use this formula for any future changes to the FMAP during the current or any future economic downturn to help ensure that the federal funding is targeted and timely. Evolving lessons from the initial response highlight the importance of the following: Establishing clear goals and defining roles and responsibilities for the wide range of federal agencies and other key players are critically important actions when preparing for pandemics and addressing an unforeseen emergency with a whole-of-government response. Providing clear, consistent communication in the midst of a national emergency—among all levels of government, with health care providers, and to the public—is key. Collecting and analyzing adequate and reliable data can inform decision-making and future preparedness—and allow for midcourse changes in response to early findings. Establishing transparency and accountability mechanisms early on provides greater safeguards and reasonable assurance that federal funds reach the intended people, are used for the intended purposes, help ensure program integrity, and address fraud risks. Why GAO Did This Study The outbreak of COVID-19 quickly spread around the globe. As of June 17, 2020, the United States had over 2 million reported cases of COVID-19, and over 100,000 reported deaths, according to federal agencies. Parts of the nation have also seen severely strained health care systems. Also, the country has experienced a significant and rapid downturn in the economy. Four relief laws, including the CARES Act, were enacted as of June 2020 to provide appropriations to address the public health and economic threats posed by COVID-19. In addition, the administration created the White House Coronavirus Task Force. The CARES Act includes a provision for GAO to report bimonthly on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. This initial report examines key actions the federal government has taken to address the COVID-19 pandemic and evolving lessons learned relevant to the nation's response to pandemics, among other things. GAO reviewed data and documents from federal agencies about their activities and interviewed federal and state officials as well as industry representatives. GAO also reviewed available economic, health, and budgetary data. What GAO Recommends GAO is making 3 new recommendations for agencies and 3 matters for consideration for Congress that are detailed in this Highlights and in the report. For more information, contact A. Nicole Clowers, (202) 512-7114 or clowersa@gao.gov. Thu, 25 Jun 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-655T What GAO Found The United States still lacks a comprehensive plan for national aviation preparedness to limit the spread of communicable diseases through air travel. In December 2015 during the Ebola epidemic, GAO recommended that the Department of Transportation (DOT) work with relevant stakeholders, such as the Department of Health and Human Services (HHS), to develop a national aviation-preparedness plan for communicable disease outbreaks. GAO concluded that the absence of a national plan undermined the ability of the public-health and aviation sectors to coordinate on a response or to provide consistent guidance to airlines and airports. Moreover, Annex 9 to an international aviation treaty to which the United States is a signatory contains a standard that obligates member states to develop such a plan. DOT is now confronting an even more widespread public health crisis—the Coronavirus Disease (COVID-19) global pandemic—without having taken steps to implement this recommendation. Not only could such a plan provide a mechanism for the public-health and aviation sectors to coordinate to more effectively prevent and control a communicable disease threat, it could also help minimize unnecessary disruptions to the national aviation system, disruptions that to date have been significant. Some aviation stakeholders have publicly highlighted the resulting piecemeal approach to adopting standards during the response to COVID-19, such as various airline and airport policies regarding facemasks, as demonstrating the need for a more coordinated response. The existence of a national plan might have reduced some of the confusion among aviation stakeholders and passengers. While DOT agrees that a national aviation preparedness plan is needed, the agency continues to suggest that HHS and the Department of Homeland Security have responsibility for communicable disease response and preparedness planning. GAO continues to believe that DOT is in the best position to lead this effort given its oversight responsibilities and ties with relevant aviation stakeholders. The Federal Aviation Administration (FAA) has sponsored limited federal research into disease transmission onboard aircraft and in airports. FAA's research goals focus on areas like improving airport operations and air space management, and developing new technologies, which FAA has aligned to DOT's strategic goals related to safety, infrastructure, and innovation. Based on prior work and interviews with FAA officials, GAO found that FAA's research in cabin safety for crew and passengers does not focus on disease transmission. For example, according to FAA officials, ongoing research that most closely relates to disease contamination is research related to monitoring the quality of “bleed air,” which is outside air that is drawn through jet engines into an aircraft cabin. In 2017, GAO found that FAA could be more strategic in how it develops its research and development (R&D) portfolio, chiefly in identifying long-term research needs and explaining how FAA selects projects. Of the three recommendations GAO made in that report to improve FAA's management of its R&D portfolio, FAA fully addressed one, issuing guidance in 2018 on prioritizing and selecting R&D projects. While FAA has made some progress addressing GAO's recommendations on research portfolio development and reporting, further attention to these recommendations could help ensure that FAA strategically identifies research priorities across the agency. Why GAO Did This Study The transmission of COVID-19 has been greatly aided by air travel. In light of the pandemic and warnings about the risks of air travel, U.S. passenger airline traffic fell by 96 percent in April 2020 as compared to April 2019. COVID-19 is only the latest communicable disease threat to raise public health concerns regarding the spread of contagion through air travel. Ensuring that the United States is prepared to respond to disease threats from air travel, as well as conducting the necessary research to reduce the risks of contagion, are two vital responsibilities of the federal government. This statement provides information on (1) the U.S. aviation system's preparedness to respond to communicable disease threats and (2) FAA's management of its R&D portfolio, including the extent to which disease transmission on aircraft and at airports has been the focus of FAA research. This statement is based on GAO-16-127 issued in December 2015 and GAO-17-372 issued in April 2017. GAO conducted updates to obtain information on the actions agencies have taken to address these reports' recommendations. What GAO Recommends GAO made several recommendations in its prior work, including that DOT develop a comprehensive national aviation-preparedness plan, and that FAA identify long-term R&D priorities, among other things. Progress has been made in addressing some of the recommendations. Continued attention is needed to ensure that the remainder of these recommendations are addressed. For more information, contact Heather Krause, 202-512-2834, krauseh@gao.gov. Tue, 23 Jun 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-525 What GAO Found Major natural disasters in the past 3 years, as well as the COVID-19 pandemic, have heightened attention to the nation's ability to respond to these types of emergencies. The Department of Health and Human Services (HHS) is responsible for leading the public health and medical response to emergencies. HHS responded to COVID-19, in part, by deploying responders enrolled in the National Disaster Medical System (NDMS). These individuals, such as doctors and nurses, generally work outside the federal government and are federal employees used intermittently. In 2018, HHS developed an enrollment target for NDMS of 6,290 responders, but GAO found HHS did not follow key principles of effective strategic workforce planning in developing this target. For example, HHS did not identify the critical skills and competencies needed of its NDMS workforce to meet current and future programmatic results. Specifically, HHS's target does not take into consideration three key areas: a workforce capable of responding to (1) a nationwide event or multiple concurrent events, (2) the needs of at-risk individuals, and (3) the availability of other medical responders. Consequently, HHS cannot be sure its target, if achieved, will provide an adequate number of responders with the skill sets needed to effectively respond. HHS requires responders to take web-based training prior to deployment, such as characteristics of infectious diseases, and also offers optional in-person training, such as care delivery in a severe environment. However, HHS's process to evaluate its training does not align with key practices. As a result, HHS does not have assurance that it is effectively preparing responders for deployment, including keeping them and others safe during an emergency, such as COVID-19. For example, HHS requires a web-based course on donning and doffing personal protective equipment to protect against infectious disease, biological, and chemical threats. However, HHS does not know the training's effectiveness until responders have deployed; at which point, if ineffective, responders could potentially expose themselves to hazards. Further, HHS officials state their in-person training is most beneficial but more costly to provide, limiting its provision. A more effective training evaluation process would help the agency determine which in-person courses are most beneficial and should be prioritized, or even made mandatory, for effective and safe responder deployment. Why GAO Did This Study NDMS is the main program through which HHS enrolls responders to assist with the federal medical and public health response to public health emergencies. HHS deploys NDMS responders to provide, among other things, patient care and movement. During the 2017 hurricanes, NDMS had a shortage of responders that resulted in HHS relying on other departments, such as the Department of Defense, to provide medical care. As of December 2019, HHS had 3,667 NDMS responders. The Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 included a provision for GAO to review HHS's responder surge capacity. This report examines (1) the workforce planning for NDMS responders to assist with public health emergencies, and (2) training provided to these responders. To conduct this work, GAO reviewed agency NDMS planning documentation, including NDMS staffing decisions, team structures, and training materials; compared HHS actions to key workforce planning practices; and interviewed HHS officials. What GAO Recommends GAO is making five recommendations to HHS, including to develop a workforce target that accounts for the critical skills and competencies that are needed to meet current and future programmatic results and to develop processes for evaluating its training to ensure an effectively trained workforce. HHS concurred with our recommendations and generally plans to take action. For more information, contact Mary Denigan-Macauley at (202) 512-7114 or deniganmacauleym@gao.gov. Thu, 18 Jun 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-534 What GAO Found According to the Centers for Disease Control and Prevention (CDC), one in three adults have experienced domestic violence, also known as intimate partner violence. Intimate partner violence includes physical violence, sexual violence, stalking, and psychological aggression. Victims of intimate partner violence may experience brain injury, resulting from blows to the head or strangulation. To address this issue, the Department of Health and Human Services (HHS) and the Department of Justice (DOJ) provide grants to state and local entities that work with victims. GAO identified 12 non-federal initiatives that provide education, screen for, or treat brain injuries resulting from intimate partner violence. All 12 developed and distributed education and training materials to domestic violence shelter staff, victims, health care providers, and others. Six of the 12 initiatives used screening tools to identify potential brain injuries among intimate partner violence victims, and two included a treatment component. Additionally, eight of the 12 initiatives received HHS or DOJ grant funding, although agency officials told us the funding had no specific requirements to address brain injuries resulting from intimate partner violence. Excerpt of Educational Materials from Ohio Domestic Violence Network Based on its review of the literature, as well as interviews with HHS officials and other non-federal stakeholders, GAO found that data on the overall prevalence of brain injuries resulting from intimate partner violence are limited. HHS officials acknowledged that the lack of data on the prevalence of these issues is a challenge in addressing the intersection of the issues. However, HHS does not have a plan for how it would collect better prevalence data. HHS agencies have some related efforts underway; however, the efforts are limited and generally do not examine the connection between brain injuries and intimate partner violence. Enhancing the health and well-being of Americans is critical to HHS's public health mission. As part of this mission, CDC, within HHS, uses its Public Health Approach, which includes collecting prevalence data to understand the magnitude of public health issues. With better data comes a better understanding of the overall prevalence of brain injuries resulting from intimate partner violence. This, in turn, could help ensure that federal resources are allocated to the appropriate areas and used as efficiently and effectively as possible to address this public health issue. Why GAO Did This Study Research has found brain injuries to be common among victims of intimate partner violence, and that such injuries are under-diagnosed and under-treated. House Report 115-952 included a provision for GAO to report on the relationship between intimate partner violence and brain injuries. GAO (1) describes efforts to provide education, screen for, or treat brain injuries resulting from intimate partner violence; and (2) examines what is known about the prevalence of brain injuries resulting from intimate partner violence, including HHS efforts to determine prevalence. GAO reviewed peer-reviewed literature, federal websites, and documentation from HHS and DOJ. GAO also interviewed officials from HHS, DOJ, and 11 non-federal stakeholders, such as domestic violence organizations. GAO identified 12 initiatives, though this list may not be exhaustive, and conducted site visits to three of them. What GAO Recommends HHS should develop and implement a plan to improve data collected on the prevalence of brain injuries resulting from intimate partner violence and use these data to inform its allocation of resources to address the issue. HHS concurred with our recommendation and is coordinating with its agencies to augment data collection. For more information, contact Carolyn L. Yocom at (202) 512-7114 or yocomc@gao.gov. Fri, 12 Jun 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-473 What GAO Found The Department of Veterans Affairs (VA) used a multi-step process to help ensure that its future commercial electronic health record (EHR) system is configured appropriately for, and is compatible with, its clinical work processes. To configure the EHR system, which VA planned to implement initially at the Mann-Grandstaff VA Medical Center, in Spokane, Washington, in July 2020, and at the Puget Sound Health Care System in the fall of 2020, VA established 18 EHR councils comprising VA clinicians, staff, and other experts in various clinical areas and held eight national workshops between November 2018 and October 2019. At these workshops, the councils decided how to design the functionality of the EHR software to help clinicians and other staff deliver care and complete tasks such as administering medication. VA also held eight local workshops at both medical centers to help ensure that the EHR configuration supported local practices. As of March 2020, the EHR councils were continuing to meet to complete configuration decisions. Furthermore, VA plans to hold local workshops in advance of the EHR system implementation at future VA medical facilities. In April 2020, the VA Secretary announced that the department had shifted priorities to focus on caring for veterans in response to the pandemic created by COVID-19. According to program officials, at that time, they paused the implementation of the EHR system and were assessing the impact of the COVID-19 pandemic on VA's planned implementation schedule. Electronic Health Record (EHR) System Configuration Decision Process GAO found that VA's decision-making procedures were generally effective as demonstrated by adherence to applicable federal internal control standards for establishing structure, responsibility, and authority, and communicating internally and externally, but that VA did not always ensure key stakeholder involvement. Specifically, the councils included a wide range of stakeholders from various geographic regions. However, according to clinicians from the two initial medical facilities for implementation, VA did not always effectively communicate information to stakeholders, including medical facility clinicians and staff to ensure relevant representation at local workshop meetings. As a result, local workshops did not always include all relevant stakeholders. VA has not indicated how it plans to describe these future sessions and define key terms to ensure key stakeholder participation in local workshops. By ensuring that all relevant stakeholders are included, VA will increase the likelihood that it is obtaining input from a wide range of clinicians and staff who will use the EHR system and will increase the likelihood that when it is implemented, the EHR system will effectively support the delivery of care at VA medical centers. Why GAO Did This Study VA's existing EHR system is antiquated, costly to maintain, and does not fully support VA's need to exchange health records with other organizations, such as the Department of Defense. As a result, VA has undertaken a modernization effort to replace it. As VA prepares to transition from its existing EHR system to a commercial system, it has the opportunity to design standardized work processes to support the delivery of care and ensure information on veterans' care is consistently captured, regardless of site of care. GAO was asked to review VA's EHR system configuration process. This report examines, among other objectives: (1) how VA made EHR system configuration decisions and assessed the compatibility of the commercial EHR system with its work processes; and (2) the effectiveness of VA's decision-making procedures, including ensuring key stakeholder involvement. GAO observed national and local workshop meetings; visited planned initial implementation sites; reviewed documentation on the processes and schedule; and interviewed VA, DOD, and contractor officials. What GAO Recommends GAO is recommending that VA ensure the involvement of all relevant medical facility stakeholders in the EHR system configuration decision process. VA concurred with GAO's recommendation. For more information, contact Debra A. Draper, (202) 512-7114 or DraperD@gao.gov or Carol C. Harris at (202) 512-4456 or HarrisCC@gao.gov. Fri, 05 Jun 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-626T What GAO Found In December 2019, GAO found that a growing number of foreign drug manufacturing inspections conducted by the Food and Drug Administration (FDA) were in China and India (43 percent in 2018), where most establishments that manufacture drugs for the United States were located. In fiscal year 2015, FDA, for the first time, conducted more foreign inspections than domestic inspections. However, from fiscal year 2016 through 2018, both foreign and domestic inspections decreased—by about 10 percent and 13 percent, respectively. FDA officials attributed the decline, in part, to vacancies among investigators available to conduct inspections. In March 2020, FDA announced that, due to Coronavirus Disease 2019 (COVID-19), it was postponing almost all inspections of foreign manufacturing establishments. While FDA has indicated it has other tools to ensure the safety of the U.S. drug supply, the lack of foreign inspections removes a critical source of information about the quality of drugs manufactured for the U.S. market. The 10 Countries with the Most Foreign Drug Establishments Shipping to the United States as of March 2019, by Country GAO also found that FDA had vacancies among each of the groups of investigators who conduct foreign inspections. FDA had 190 investigators in the United States who conduct the majority of foreign inspections, but an additional 58 positions were vacant. At the time of GAO's December 2019 testimony, FDA was in the process filling 26 of these vacancies, with 32 remaining. However, according to FDA officials, it could be 2 to 3 years before new staff are experienced enough to conduct foreign inspections. FDA also faced persistent vacancies among investigators in its foreign offices. GAO further found in December 2019 that FDA investigators identified persistent challenges conducting foreign inspections, raising questions about the equivalence of foreign to domestic inspections. Specifically, GAO found: While FDA inspections performed in the United States were almost always unannounced, FDA's practice of preannouncing foreign inspections up to 12 weeks in advance may have given manufacturers the opportunity to fix problems ahead of the inspection. Investigators from FDA's China and India offices had conducted some unannounced inspections, but these staff do not perform most of the inspections in these countries (27 percent and 10 percent, respectively). FDA Estimates of the Amount of Notice Provided to Foreign Drug Establishments Prior to Inspection, Fiscal Year 2018 Type of investigator Amount of notice provided Percentage of inspections involving this investigator type China office investigator 0-5 days Involved in 27 percent of total number of inspections in China India office investigator 0-5 days. Involved in 10 percent of total number of inspections in India U.S.-based investigator Generally 12 weeks Involved in: 73 percent of total number of inspections in China 90 percent of total number of inspections in India 100 percent of total number of inspections in other foreign countries Source: Interviews with Food and Drug Administration (FDA) officials and GAO analysis of FDA data. | GAO-20-626T FDA was not generally providing translators on foreign inspections. Rather, FDA continued to rely on translators provided by the foreign establishments being inspected, which investigators said raised questions about the accuracy of information FDA investigators collected. For example, one investigator said there was more risk of conflict of interest if the establishment used its own employees to translate. In addition, the establishment representative providing the translation may be someone who does not have the technical language needed, which can make it harder to communicate with establishment staff and facilitate the inspection. The overseas travel schedule can present challenges for FDA's domestically based investigators, who conduct the majority of foreign inspections. Domestically based investigators told us there is little flexibility for them to extend foreign inspections during an overseas trip. The inspections they conduct on an overseas trip are scheduled back-to-back in 3-week trips and may involve three different countries. Therefore, extending one inspection would limit the amount of time the investigator has to complete their other scheduled inspections. FDA officials said that inspections conducted by investigators based in China or India (and domestic inspections in the United States) are generally scheduled one at a time and can thus more easily be extended if the investigator needs additional time to pursue potential deficiencies. However, these in-country investigators are not involved in the majority of FDA inspections conducted in China or India. Why GAO Did This Study The outbreak of COVID-19 has called greater attention to the United States' reliance on foreign drug manufacturers and further highlighted the importance of ensuring a safe pharmaceutical supply chain. Much of the manufacturing of drugs for treating COVID-19 occurs overseas, which is also true of the majority of other drugs marketed in the United States. While the volume of drugs manufactured overseas for the U.S. market is not fully known, FDA reports that about 70 percent of establishments manufacturing active ingredients and more than 50 percent of establishments manufacturing finished drugs for the U.S. market were located overseas, as of August 2019. FDA is responsible for overseeing the safety and effectiveness of all drugs marketed in the United States, regardless of where they are produced, and conducts inspections of both foreign and domestic drug manufacturing establishments. GAO has had long-standing concerns about FDA's ability to oversee the increasingly global pharmaceutical supply chain, an issue highlighted in GAO's High Risk Series since 2009. In particular: GAO recommended in 2008 (GAO-08-970) that FDA increase the number of inspections of foreign drug establishments. GAO found in 2010 (GAO-10-961) that FDA continued to conduct relatively few foreign inspections than domestic inspections. GAO found in 2016 (GAO-17-143) that FDA was conducting more of these foreign drug inspections, and GAO closed its 2008 recommendation to conduct more foreign inspections. However, GAO also reported that FDA may have never inspected many foreign establishments manufacturing drugs for the U.S. market. In addition, in the summer of 2018, FDA began announcing recalls of blood pressure medications manufactured overseas that were tainted with a potential carcinogen, raising further questions about FDA’s oversight of foreign-manufactured drugs. This statement is largely based on GAO’s December 2019 testimony (GAO-20-262T) and discusses 1. the number of foreign inspections FDA has conducted, 2. inspection staffing levels, and 3. challenges unique to foreign inspections. For that testimony, GAO examined FDA data from fiscal years 2012 through 2018 and interviewed investigators from FDA’s 2019 cadre of investigators (who are based in the United States but exclusively conduct foreign drug inspections) and from FDA’s foreign offices in China and India. For more information, contact Mary Denigan-Macauley at (202) 512-7114 or deniganmacauleym@gao.gov. Tue, 02 Jun 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-371 What GAO Found The Department of Defense's (DOD) methodology to determine Medical Treatment Facilities' (MTF) restructuring actions in its implementation plan (the Plan) prioritized statutory elements. These included military readiness, adequacy of nearby civilian health care, and cost-effectiveness. However, DOD based part of its methodology on incomplete and inaccurate information. Civilian health care assessments did not consistently account for provider quality. DOD generally assumed that identified providers were of sufficient quality. GAO found that DOD considered the quality of nearby civilian providers for one of 11 selected MTFs. In this instance, information from the MTF about the variable quality of nearby civilian health care led to DOD's determination that such care was not yet adequate to support MTF restructuring. Officials GAO interviewed from other MTFs discussed concerns about quality of care from nearby civilian providers. Civilian health care assessments did not account for access to an accurate and adequate number of providers near MTFs. DOD may have included in its assessments providers who do not meet DOD's access-to-care standards for certain beneficiaries. For 11 selected MTFs, GAO found that about 56 percent of civilian primary care providers and 42 percent of civilian specialty providers that DOD identified as being nearby exceeded DOD's drive-time standards. Including such providers in its assessments means that DOD could have overestimated the adequacy of civilian health care providers in proximity to some MTFs. Cost-effectiveness assessments were based on a single set of assumptions. DOD concluded that civilian health care was more cost-effective than care in its MTFs without considering other assumptions that could affect its conclusions. For example, DOD applied assumptions about the cost of military personnel salaries, MTF workloads, and reimbursement rates for TRICARE that likely underestimated the cost-effectiveness of MTFs. GAO also found that DOD conducted limited assessments of MTFs' support to the readiness of military primary care and nonphysician medical providers—an issue DOD officials stated they will address during MTF transitions. Until DOD resolves methodology gaps by using more complete and accurate information about civilian health care quality, access, and cost-effectiveness, DOD leaders may not fully understand risks to their objectives in restructuring future MTFs. DOD's Plan identified actions needed to facilitate MTF restructuring, but the department is not well positioned to execute the transitions. DOD's Plan poses challenges for the military departments and the Defense Health Agency (DHA) related to MTF providers' readiness. Yet, DOD plans to move forward with restructuring without a process to monitor progress and challenges. By establishing roles and responsibilities for executing and monitoring MTF restructuring transitions, DOD can be better positioned to navigate organizational boundaries between the DHA that manages the MTFs and the military departments that provide staff. Additionally, by defining measurable objectives and progress thresholds, DOD can better ensure it is meeting objectives and facilitating timely adjustments to MTF restructuring transitions, as needed. Why GAO Did This Study DOD's MTFs are critical to the medical readiness of servicemembers and providing readiness training for about 107,000 active-duty medical providers. About 9.6 million beneficiaries are eligible for DOD health care through MTFs and civilian network providers. To further support readiness, the National Defense Authorization Act (NDAA) for Fiscal Year 2017 required DOD to plan to restructure MTFs. DOD's February 2020 Plan included decreasing capabilities at 43 MTFs and closing five. The NDAA included a provision for GAO to review the Plan. This report addresses the extent to which 1) the Plan's methodology prioritized statutory elements and considered complete information, and 2) DOD is positioned to execute MTF restructuring transitions. GAO reviewed DOD's Plan, MTF workload and cost data, and interviewed DOD leaders and officials at 11 MTFs selected on the basis of military department, restructuring action, and location. What GAO Recommends GAO is making six recommendations, including that future MTF assessments use more complete and accurate information about civilian health care quality, access, and cost-effectiveness; and that DOD establish roles, responsibilities, and progress thresholds for MTF transitions. DOD partially concurred with four recommendations and concurred with two. As discussed in the report, GAO continues to believe that all six recommendations are warranted. For more information, contact Brenda S. Farrell at (202) 512-3604 or farrellb@gao.gov. Fri, 29 May 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-583SP Why This Matters SARS-CoV-2 causes COVID-19, and developing a vaccine could save lives and speed economic recovery. The United States is funding multiple efforts to develop vaccines. Developing a vaccine is a complicated process that is costly, typically requires 10 years or more, and has a low success rate, although efforts are underway to accelerate the process. The Technology What is it? Vaccines protect people from disease by triggering the immune system to produce antibodies that will fight the pathogen attacking the body. In the case of COVID-19, the pathogen is the virus SARS-CoV-2. Developing a vaccine is an expensive, lengthy process that involves a rigorous series of steps to first identify a potential vaccine "candidate" and then assess it for safety and effectiveness. How does it work? A vaccine can use a virus that has been modified to be safe or a molecule that resembles a part of the virus. Once antibodies are produced, if the vaccinated person is exposed later to the virus, their body will produce those antibodies again, increasing their chances of fighting off infection. Development starts with identifying a "target," such as a protein, that can induce an immune reaction. Researchers create a vaccine candidate similar to that target that will induce production of antibodies effective against the virus. The vaccine candidate is then moved through phases of development, assessment, and approvals (fig. 1). Figure 1. The vaccine development process typically takes 10 to 15 years under a traditional timeline. Multiple regulatory pathways, such as Emergency Use Authorization, can be used to facilitate bringing a vaccine for COVID-19 to market sooner. Under normal circumstances, the entire process typically takes 10 to 15 years, with more than 65 percent of candidates failing, according to an MIT study. There is an effort to expedite this process for SARS-CoV-2. As of May 15, 2020, there are more than 110 COVID-19 vaccines in development globally; of those, at least three are being developed in the United States with federal funding. These three use different mechanisms to prompt the body to produce antibodies (fig. 2). Figure 2. Vaccine candidates use different mechanisms, such as those shown above, to prompt the body to produce antibodies against SARS-CoV-2. The first candidate, developed by National Institute of Allergy and Infectious Diseases scientists and their collaborators, uses a molecule called mRNA specifically coded to generate proteins that will induce an immune response. This is a newer method of vaccine development that has shown promise in animals during the preclinical phase. The second candidate uses a recombinant protein, which is produced by genetically engineering bacteria or other cells to produce a protein that mimics part of the spike protein found on the surface of the SARS-CoV-2 virus. The spike protein alone does not cause an infection but may be sufficient to produce an immune response. Recombinant protein vaccines are already being used successfully against other viruses, such as the human papillomavirus (HPV), which can cause cervical cancer. The third candidate uses a virus—adenovirus 26, or Ad26—but researchers have removed its infectious aspects, making it safe as a "vector" to deliver a piece of SARS-CoV-2 to trigger a protective immune response. This method is also in clinical trials against HIV and Ebola. How mature is it? The process for developing a new vaccine as outlined by the Food and Drug Administration (FDA) is well established. In the exploratory phase, the target and candidate vaccine are identified. In the preclinical phase, researchers use cells and animals to assess safety and produce evidence of clinical promise, evaluated by the candidate's ability to elicit a protective immune response. During clinical trials, more human subjects are added at each successive phase. Safety, efficacy, proposed doses, schedule of immunizations, and method of delivery are evaluated. The next phase is FDA approval and licensure, which includes oversight of manufacturing and postmarket surveillance, and may include Phase IV trials to monitor safety and efficacy, potency, purity, and other potential uses. At any phase, the process can be terminated for various reasons including detection of adverse events, such as serious side effects. FDA has four programs to facilitate and expedite the review and approval of new therapies for the treatment and prevention of serious or life-threatening conditions, such as COVID-19. Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review allow for expedited processes, such as overlapping vaccine development phases, to bring vaccines to market more quickly. Vaccine developers could potentially use any or all of these programs for vaccine candidates in the United States. FDA can also issue Emergency Use Authorizations (EUA) for review of vaccine candidates that have not completed all phases of development if there is sufficient scientific evidence on the product’s safety, effectiveness, risks, and benefits. Opportunities Several technologies and initiatives offer opportunities to accelerate vaccine development. For example: Genomic tools. Tools that provide information about a pathogen’s genetic makeup can reduce the length of time for target selection. Collaboration and partnerships. The National Institutes of Health’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) effort is a public-private partnership intended to provide a collaborative framework for vaccine development. Multiple vaccine mechanisms. Simultaneous testing of multiple vaccine mechanisms can improve the chances of developing a successful vaccine faster. Challenges Virus mutations. RNA viruses, such as SARS-CoV-2, can mutate and potentially reduce or eliminate a vaccine’s effectiveness, potentially creating a need for new vaccines. Risk from accelerated process. According to FDA, accelerating vaccine development could increase risk of adverse effects, since less time would be allocated to proving safety and effectiveness. Manufacturing and supply issues. Some production process and materials needs vary by vaccine type, complicating early expansion of manufacturing. Increasing export restrictions, dependence on imported supplies, and competition for materials may constrain access to supplies. Policy Context and Questions What mechanisms could be used for quickly scaling up vaccine manufacturing, production, and distribution? If a vaccine becomes available, who will have priority to be vaccinated? How will the vaccine be purchased and distributed, particularly if distribution requires special handling (e.g., maintaining a specific temperature)? How could vaccines developed or manufactured internationally be made more accessible for use within the United States? If a vaccine is not developed and widely available soon, what preparations are needed for a possible second wave of the COVID-19 outbreak this fall and winter? For more information, contact Karen Howard at 202-512-6888 or HowardK@gao.gov. Tue, 26 May 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-408 What GAO Found GAO's analysis of Medicare claims data shows that in 2018 almost 5 million beneficiaries used behavioral health services—services for mental and substance use disorders. This represented about 14 percent of the more than 36 million fee-for-service (traditional) Medicare beneficiaries and reflects about $3.3 billion in spending. Additionally, about 96 percent of all behavioral health services accessed by Medicare beneficiaries in 2018, the latest data available, were for a primary diagnosis in one of five behavioral health disorder categories. (See figure.) Mood disorders, such as depression and bipolar disorders, accounted for 42 percent of services. SUD services accounted for about 7 percent of all services accessed by beneficiaries. Further, two-thirds of behavioral health services were provided by psychiatrists, licensed clinical social workers, and psychologists in 2018. Number of Behavioral Health Services Accessed by Medicare Beneficiaries, by Diagnosis Group, 2018 The Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services' (HHS) agency that administers Medicare, uses various approaches to disseminate information to Medicare beneficiaries about coverage for behavioral health services. As part of these efforts, CMS mails out Medicare & You —the most widely disseminated source of information on Medicare benefits—to all Medicare beneficiaries every year. GAO reviewed the fall 2019 and January 2020 editions of Medicare & You. While the January 2020 edition describes a new coverage benefit for beneficiaries with opioid use disorders, neither edition includes an explicit and broader description of the covered services available for substance use disorders. Both HHS and CMS have stated that addressing substance use disorders is a top priority. Given that coverage for substance use disorders is not explicitly outlined in Medicare's most widely disseminated communication, Medicare beneficiaries may be unaware of this coverage and may not seek needed treatment as a result. Why GAO Did This Study Behavioral health disorders often go untreated, potentially leading to negative health consequences. Behavioral health disorders include substance use or mental health disorders. Medicare provides coverage for behavioral health services. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act enacted in 2018 included a provision for GAO to examine Medicare behavioral health services and how beneficiaries are informed of coverage and treatment options. This report (1) describes the utilization of behavioral health services by Medicare beneficiaries and the types of providers furnishing these services, and (2) examines how CMS provides information to beneficiaries about their coverage for behavioral health services. To describe service utilization and provider types, GAO analyzed 2018 Medicare claims data, the most recent data available. To examine how CMS shares information with beneficiaries, GAO reviewed CMS requirements for providing coverage information to beneficiaries, reviewed CMS publications, and interviewed CMS officials. What GAO Recommends CMS should include explicit information on the services covered by Medicare for beneficiaries with substance use disorder in its Medicare & You publication. HHS reviewed a draft of this report and concurred with the recommendation. For more information, contact James C. Cosgrove at (202) 512-7114 or cosgrovej@gao.gov. Thu, 21 May 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-337 What GAO Found Workforce officials GAO interviewed in four of the 10 states receiving targeted Department of Labor (DOL) grants as of March 2019 said they were using Workforce Innovation and Opportunity Act (WIOA) funding to help meet the unique needs of those affected by substance use disorder (SUD). These officials, who said they had limited experience serving those affected by SUD, worked with required organizational partners and hired specialists to assist job seekers and to provide intensive job readiness services. However, these efforts are relatively new and outcomes are not yet known. Workforce officials GAO interviewed in two selected states without targeted grants said they had viewed SUD primarily as a public health issue, but had recently taken some steps to address it. For example, one state added a workforce subcommittee to an existing opioid task force. State and local workforce officials in all six states identified a range of challenges they face in addressing the needs of SUD-affected job seekers. For example, criminal history or a lack of transportation may make it difficult for these job seekers to obtain and maintain employment. Officials said another challenge is finding employers who are willing to hire those in recovery. They stated that employers are concerned about the risks to their businesses, such as potential employee relapse and possible negative reaction from customers. Officials were seeking more information and assistance to help address such concerns. Criminal Histories May Deter Potential Employers from Hiring Those in Recovery DOL officials said they support SUD-affected communities mainly by providing information to states that apply for and receive targeted grants. However, officials in two selected states expressed uncertainty about DOL's expectations of states in serving the needs of SUD-affected job seekers and potential employers. Officials in another state said they were unclear on whether they could use non-targeted funds to continue targeted grant activities. GAO's review of related DOL guidance found that it does not provide specific information on expectations of states or the use of WIOA funds outside of targeted grants to address this issue. Further, while DOL has disseminated some information on serving job seekers with SUD (such as in quarterly calls with grant recipients), it does not plan to share information that grantees submit to the agency, such as lessons learned and successes, with all states. Doing so could help states meet the training and employment needs of those in recovery, and the needs of potential employers. Why GAO Did This Study The Department of Health and Human Services declared the opioid crisis a public health emergency in October 2017. DOL has awarded grants to help address this crisis. GAO was asked to examine how WIOA-funded programs are addressing the employment and training needs of those affected by SUD. This report examines (1) how workforce agencies in selected states are using WIOA funding to address employment and training needs, (2) challenges agencies face in addressing employment and training needs, and (3) how DOL is supporting communities affected by SUD. GAO interviewed officials in four of the 10 states that received DOL grants in the early award rounds (as of March 2019)—Maryland, New Hampshire, Ohio, and Washington—and two that did not—Alabama and Arizona; reviewed related documentation and relevant federal laws and regulations; and interviewed DOL officials and researchers, selected for their knowledge about these issues. What GAO Recommends GAO recommends that DOL clarify (1) its expectations of state workforce agencies and (2) how WIOA funding can be used in addressing the needs of those affected by SUD and potential employers, and share information with all states on lessons learned and promising practices. DOL agreed with our recommendations. For more information, contact Jacqueline M. Nowicki at (617) 788-0580 or nowickij@gao.gov. Thu, 21 May 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-576R What GAO Found The Centers for Medicare & Medicaid Services (CMS), an agency within the Department of Health and Human Services (HHS), is responsible for ensuring that approximately 15,500 nursing homes nationwide meet federal quality standards. These standards require, for example, that nursing homes establish and maintain an infection prevention and control program. CMS enters into agreements with state survey agencies to conduct surveys and investigations of the state's nursing homes and to cite nursing homes with deficiency citations if the home is not in compliance with federal standards. Infection prevention and control deficiencies cited by surveyors can include situations where nursing home staff did not regularly use proper hand hygiene or failed to implement preventive measures during an infectious disease outbreak, such as isolating sick residents. Many of these practices can be critical to preventing the spread of infectious diseases, including COVID-19. GAO analysis of CMS data shows that infection prevention and control deficiencies were the most common type of deficiency cited in surveyed nursing homes, with most nursing homes having an infection prevention and control deficiency cited in one or more years from 2013 through 2017 (13,299 nursing homes, or 82 percent of all surveyed homes). In each individual year, we found that about 40 percent of surveyed nursing homes had infection prevention and control deficiencies, and this continued in 2018 and 2019. About half—6,427 of 13,299 (48 percent)—of the nursing homes with an infection prevention and control deficiency had this deficiency cited in multiple consecutive years from 2013 through 2017. This is an indicator of persistent problems at these nursing homes. In each year from 2013 through 2017, nearly all infection prevention and control deficiencies (about 99 percent in each year) were classified by surveyors as not severe, meaning the surveyor determined that residents were not harmed. Our review of CMS data shows that implemented enforcement actions for these deficiencies were typically rare: from 2013 through 2017, CMS implemented enforcement actions for 1 percent of these infection prevention and control deficiencies classified as not severe. We plan to examine CMS guidance and oversight of infection prevention and control in a future GAO report, including the classification of infection prevention and control deficiencies. Why GAO Did This Study COVID-19 originated in late 2019 as a new and highly contagious respiratory disease causing severe illness and death, particularly among the elderly. Because of this, the health and safety of the nation's 1.4 million nursing home residents—who are often in frail health and living in close proximity to one another—has been a particular concern. In light of the COVID-19 pandemic, GAO was asked to examine CMS's oversight of infection prevention and control protocols and the adequacy of emergency preparedness standards for emerging infectious diseases in nursing homes, as well as CMS's response to the pandemic. In this report, GAO describes the prevalence of infection prevention and control deficiencies in nursing homes prior to the COVID-19 pandemic. Future GAO reports will examine more broadly infection prevention and control and emergency preparedness in nursing homes, and CMS's response to the COVID-19 pandemic. GAO reviewed CMS guidance and analyzed data on nursing home deficiencies. Specifically, GAO analyzed deficiencies cited by surveyors in all 50 states and Washington, D.C., from 2013 through 2017 provided by CMS for a prior GAO report, with a particular focus on deficiencies related to infection prevention and control. Using these data, GAO determined the most common type of deficiency among nursing homes, and the number of nursing homes that had infection prevention and control deficiencies—as well as the nursing homes with repeated infection prevention and control deficiencies over the 5-year period from 2013 through 2017, the characteristics of those homes, and the enforcement actions associated with the infection prevention and control deficiencies. In addition to the 2013 through 2017 data GAO obtained from CMS for a prior report, GAO also examined the number of nursing homes that had infection prevention and control deficiencies in 2018 and 2019 by analyzing publicly available data from CMS's Nursing Home Compare website. What GAO Recommends GAO is not making any recommendations. GAO provided a draft copy of this report to HHS for comment. GAO received technical comments and incorporated them as appropriate. For more information, contact John E. Dicken at 202-512-7114 or dickenj@gao.gov. Wed, 20 May 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-584SP Why This Matters As the nation works to save lives and flatten the curve of COVID-19 cases, widespread testing could help reduce the death rate, help identify those who should self-isolate, and help businesses recover. There are challenges, however, associated with the use and availability of tests, as well as with determining their accuracy. The Technology What is it? There are currently three types of tests for COVID-19: molecular, antigen, and serology. Molecular tests and a new antigen test help diagnose active COVID-19 infections, and serology tests help determine whether someone was previously exposed to the novel coronavirus, which causes COVID-19. How does it work? While each kind of test takes a different approach, they all collect vital information about exposure to the virus. Molecular tests amplify and detect genetic material from novel coronavirus in a sample taken from a patient’s saliva, nose, or throat to determine whether there is an active infection (fig. 1). For example, molecular tests based on the polymerase chain reaction (PCR) use a genetic photocopier, copying a unique portion of the coronavirus genetic material, if present, until there are enough copies to detect. Antigen tests can detect the virus by binding parts of the virus, called antigens, to a membrane. Antibodies that can fluoresce are also added to the membrane. If enough antigen is present to bind to the antibodies, the total fluorescence from the antibodies becomes high enough to indicate a positive result. Serology tests, which typically require a sample of blood from a patient, can detect the presence of antibodies produced by a patient’s immune system in response to the coronavirus (fig. 1). Such antibodies can persist in the blood after a patient recovers from an infection. Thus, a positive serology test result indicates prior exposure to the novel coronavirus but does not necessarily mean that the patient is still infected. Figure 1. Most Common COVID-19 Test Types. Molecular tests detect viral genetic material. Serology tests detect antibodies against the virus. How mature is it? All three kinds of COVID-19 tests are commercially available under the Food and Drug Administration’s (FDA’s) emergency use authorization (EUA), which allows for the use of certain unapproved medical products or unapproved uses of approved medical products under certain circumstances during a public health emergency. As of May 13, 2020, FDA has authorized at least 56 molecular tests for COVID-19 via EUA; these tests generally rely on PCR technology. Devices used for administering molecular tests range in size from larger equipment to smaller, portable devices that can be used on-site near the patient. On May 8, 2020, FDA authorized the first antigen test for COVID-19 via EUA. According to FDA, antigen tests, which can be run in minutes, have a higher chance of false negatives compared to molecular tests. FDA states that negative antigen test results may need to be confirmed with a molecular test before making treatment decisions. As of May 13, 2020, FDA has authorized at least 12 serology tests for COVID-19 via EUA. For COVID-19, serology tests were first authorized by FDA about a month after molecular tests were authorized. Devices used to administer serology tests also range in size, with some about the size of an over-the-counter pregnancy test. Opportunities Testing provides critical information for a variety of purposes, including medical care, policymaking, and business. For example: Determining risk. Serology tests can help establish the percentage of the population previously exposed to the virus. Such information can help improve the accuracy of statistics on infection rates, among other things Understanding disease impact. Testing can help establish the impact of the disease, including identifying those who may have been exposed to the virus but did not show symptoms and those who recovered. This is important for characterizing the risk of the disease to the elderly and other subpopulations. Guiding treatment and resource allocation. Molecular and antigen tests can provide information on the rate and geographic location of active infections. This can help guide patient treatment and inform decisions about the distribution of medical supplies and equipment. Informing responses. Testing is also important for informing decisions on quarantine and isolation, including decisions related to health care workers. Additionally, testing can help inform public responses such as school closures and reopenings. Challenges Although widespread testing offers a number of opportunities, there are also challenges in implementation. For example: Limited information on test accuracy. The performance characteristics of some COVID-19 tests have raised concerns about test accuracy. In particular, available data suggest variability in the rates of false positive and false negative results. This uncertainty can complicate patient treatment and public health decisions. Number and timing of test results. Centralized laboratories generally have higher reported testing throughput, but may take days to report test results. Point-of-care testing conducted on-site can return results more quickly, sometimes within an hour. However, the throughput of these tests can be lower than that of central laboratories. It may be challenging to balance the need for fast results and the need for large numbers of tests (fig. 2). Figure 2. Types of test processing based on site location. Decentralized testing, including testing at the point-of-care, reduces the time to obtain test results but can have limited throughput and other challenges. Centralized testing can have higher throughput, but may take longer to provide test results. Scalability. Expanding testing to reach more people would require greater availability of resources such as personal protective equipment needed by healthcare workers. Another option for expanding testing may be for FDA to authorize the use of additional at-home sample collection kits. Allowing consumers totake their own samples, however, could result in reduced test accuracy, due to sample contamination or other issues. Policy Context and Questions There are a number of important policy issues related to COVID-19 testing. For example: What are the barriers, if any, to FDA’s and CDC’s ability to help facilitate the development and use of tests during an early stage of an outbreak, and how could any barriers be addressed? What actions could help the general public and health care workers understand and assess the accuracy and reliability of different tests? What information could help decision-makers determine the number and distribution of tests to most effectively respond to outbreaks such as the COVID-19 pandemic? How can federal, state, and local health departments coordinate to facilitate accurate and timely testing and reporting of test results? For more information, contact Karen Howard at (202) 512-6888 or HowardK@gao.gov. Wed, 20 May 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-372 What GAO Found Within the Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC) and the Office of the Assistant Secretary for Preparedness and Response (ASPR) used models to inform decision-making during and after outbreaks of Ebola, Zika, and pandemic influenza. These agencies' modeling efforts informed public health planning, outbreak response, and, to a limited extent, resource allocation. Four CDC centers perform modeling. HHS agencies reported using multiple mechanisms to coordinate modeling efforts across agencies, but they do not routinely monitor, evaluate, or report on the extent and success of coordination. Consequently, they risk missing opportunities to identify and address modeling challenges—such as communicating clearly, and obtaining adequate data and resources—before and during an outbreak. As a result, agencies may be limiting their ability to identify improvements in those and other areas. Further, there is potential for overlap and duplication of cross-agency modeling efforts, which could lead to inefficiencies. Office of the Assistant Secretary for Preparedness and Response's Visualization Hub, which Can Be Used for Infectious Disease Planning and Response CDC and ASPR generally developed and assessed their models in accordance with four steps GAO identified as commonly-recognized modeling practices: (1) communication between modeler and decision maker, (2) model description, (3) verification, and (4) validation. However, for four of the 10 models reviewed, CDC did not provide all details needed to reproduce model results, a key step that lets other scientists confirm those results. GAO found that CDC's guidelines and policy do not address reproducibility of models or their code. This is inconsistent with HHS guidelines and may jeopardize the reliability of CDC's research. This report also identifies several modeling-related challenges, along with steps agencies have taken to address them. Why GAO Did This Study Outbreaks of infectious diseases—such as Ebola, Zika, and pandemic influenza—have raised concerns from Congress about how federal agencies use modeling to, among other things, predict disease distribution and potential impacts. In general, a model is a representation of reality expressed through mathematical or logical relationships. Models of infectious diseases can help decision makers set policies for disease control and may help to allocate resources. GAO was asked to review federal modeling for selected infectious diseases. This report examines (1) the extent to which HHS used models to inform policy, planning, and resource allocation for public health decisions; (2) the extent to which HHS coordinated modeling efforts; (3) steps HHS generally takes to assess model development and performance; and (4) the extent to which HHS has addressed challenges related to modeling. GAO reviewed documents and interviewed HHS officials, state officials, and subject matter experts. GAO identified practices commonly used to assess infectious disease model performance and reviewed 10 selected modeling efforts to see if they followed these practices. What GAO Recommends GAO recommends that HHS (1) develop a way to routinely monitor, evaluate, and report on modeling coordination efforts across multiple agencies and (2) direct CDC to establish guidelines to ensure full reproducibility of its models. HHS agreed with GAO's recommendations. For more information, contact Timothy M. Persons, PhD, Chief Scientist at (202) 512-6888 or personst@gao.gov. Wed, 13 May 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-545SP Why This Matters Infectious diseases like COVID-19 can spread rapidly from person to person. Social distancing saves lives by slowing disease transmission and reducing the load on the health care system. The scientific research regarding effective social distancing practices continues to evolve. The Science What is it? Social distancing, also known as physical distancing, is the practice of maintaining physical distance from others and avoiding large gatherings, with the intent of reducing the rate of transmission of infectious diseases. COVID-19 has brought social distancing practices to the forefront worldwide as a means of controlling local spread of the disease. How does it work? Practicing social distancing reduces the rate of new infections by limiting person-to-person transmission. This in turn can “flatten the curve,” by reducing the peak number of patients to levels the health care system can better manage, ultimately saving lives (fig. 1). Figure 1. Reducing the rate of disease transmission through interventions, including social distancing and other measures, can alleviate the burden on medical facilities. The success of social distancing depends on factors such as the distance that infectious particles can spread from a contagious person. The Centers for Disease Control and Prevention (CDC) currently recommends a 2 meter (about 6 feet) separation between people, while the World Health Organization (WHO) recommends 1 meter (about 3 feet). The scientific basis for these recommendations comes from studies in fields such as fluid mechanics, epidemiology, and microbiology. For example, several studies estimated the velocity and distance traveled by droplets of different sizes expelled by sneezing, coughing, and breathing. These studies showed that sneezing and coughing can propel droplets more than 2 meters, with sneezing possibly propelling them further, and breathing less than 1 meter (fig. 2). However, these estimates of speeds and distances are not absolute maximums. Coughing and sneezing are complex phenomena that are challenging to characterize precisely. And the behavior of droplets after they are expelled depends on their size, along with environmental factors such as humidity and air currents, making it challenging to be definitive about how far they may travel. Partly as a result of this ambiguity, social distancing guidelines are often conservative, recommending minimal personal contact except when necessary, such as within one’s own household. Figure 2. Droplets carrying infectious material can travel different distances, depending on factors such as size, humidity, and air currents. Microbiological studies on a variety of respiratory viruses have shown viral material can travel 2 meters or farther from an infected patient. Specifically for COVID-19, one study showed that viral material can be recovered from ventilation fans in a patient’s room. However, it was not established whether the viral material could lead to disease transmission. How mature is it? Some modeling studies of historical outbreaks suggest that social distancing is effective in reducing the spread of infections. For example, studies examining the use of social distancing during the 1918 influenza outbreak and the 2003 SARS outbreak showed such a reduction in part due to social distancing. While it is clear that maintaining separation between individuals provides important protection, there is no definitive statement in the literature regarding effectiveness of specific distances. While a CDC guideline suggests that, historically, risk is highest within 1 meter of an infected person, the studies described above suggest a buffer of over 2 meters may further reduce risk. Still, several unknowns limit the ability to set specific guidance. For example, the risk from those droplets that travel long distances is unknown, as is the risk from viral material in aerosol form, which may persist for at least 3 hours in the air. Additionally, the amount of infectious material needed for COVID-19 transmission is not clear, nor is the effect of duration of exposure on risk, making it unclear how long two people standing 2 meters apart may safely interact. Social distancing practices, such as avoiding crowds and staying home, remain important, particularly as some infected people can shed virus before showing symptoms, according to WHO. Figure 3. Determining the necessary spacing for effective social distancing, such as for riders in a subway car, can affect the extent of disease transmission. The shaded circle (top) shows the number of people who could be directly infected by droplets from a sick person. Opportunities Social distancing offers opportunities to mitigate infectious disease spread. For example: Social distancing is readily deployable because it mainly requires authorities to disseminate directives and instructions. It does not require special equipment or medication to be distributed. It does not require special qualifications or extensive training for the public to do. It can be particularly important when no treatment or vaccine is available. It can be used to buy time for manufacturing and distributing protective supplies. Challenges People may be reluctant or unable to practice social distancing, as it may be impossible for them to do, or adversely affect their daily routine and livelihood. Certain settings, such as onboard cruise ships or military vessels, can preclude some social distancing practices. There may be psychological impacts due to interruption of services such as mental health care to vulnerable populations, among other impacts. If implemented for long periods, social distancing may lead to large-scale disruptions in the economy, social cohesiveness, and the distribution of goods and services, which need to be considered in the context of public health assessments. Scientific studies to determine which distancing strategies are effective can be challenging, expensive, and risky, in part because some studies may test conditions that result in the spread of infection. Policy Context and Questions Social distancing, as a tool for public health response, raises a number of policy issues. How, when, and for how long can social distancing be broadly implemented and enforced effectively, while minimizing disruption to the daily routine of the populace and the economy? How can key complementary practices such as diagnostic testing best be used to inform the timing, location, and duration of social distancing? What research is needed to better establish the scientific basis of disease transmission so that effective methods for social distancing can be devised and promulgated, and who should conduct such research? For more information, contact Karen Howard at 202-512-6888 or HowardK@gao.gov. Wed, 13 May 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-531R What GAO Found On April 20, 2020, the Department of Health and Human Services (HHS) issued regulations for the recruitment and retention of research scientists actively engaged in biomedical research or clinical research evaluation to support its mission. This was done to implement authorities provided by the 21st Century Cures Act (enacted in December 2016). HHS officials said that the HHS agencies that are expected to use the authority for recruitment and retention are National Institutes of Health (NIH), Food and Drug Administration (FDA), Centers for Disease Control and Prevention, and Agency for Healthcare Research and Quality. According to HHS officials, the department is preparing guidance based on discussion with its agencies for the allocation of specific membership slots for each agency for recruitment and retention. NIH and FDA officials told GAO that after they receive their membership slots, they would begin their recruitment and retention process. FDA officials said that process could take up to 6 months until scientists are selected. Why GAO Did This Study HHS has cited difficulties in recruiting and retaining individuals in medicine, science, engineering, and other related fields to support its mission. Since 2001, GAO has designated strategic human capital management as a government-wide high-risk area in part because of the need to address current and emerging skills gaps that are undermining agencies' abilities to meet their missions. HHS agencies have cited difficulties recruiting and retaining scientists for a variety of reasons, including pay that is not competitive with the private sector. To provide additional hiring and retention authority to HHS, the 21st Century Cures Act revised and renamed one mechanism as the Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service (the Service). Among other things, it provides for the appointment of up to 2,000 scientists—1,500 more than the prior authorization—with doctoral or master's degrees in specialized areas (such as engineering, bioinformatics and related fields), and increases the top pay to be consistent with the President's salary. The Act also included a provision that GAO report on the extent to which the recruitment and retention of biomedical research scientists and those in related fields at HHS has been affected by these amendments. In this report, GAO describes HHS's efforts to implement the recruitment and retention authorities of the Service. To do so, GAO reviewed documentation about various hiring mechanisms, including the Service. GAO also interviewed departmental officials at HHS, as well as agency officials at NIH and FDA, about their implementation efforts. For more information, contact Mary Denigan-Macauley at 202-512-7114 or deniganmacauleym@gao.gov. Fri, 08 May 2020 00:00:00 -0400 https://www.gao.gov/products/GAO-20-447R What GAO Found The Department of Veterans Affairs (VA) may obtain advice and recommendations from private citizens and other entities to inform various agency decisions. GAO reviewed VA officials' interactions with three private citizens—Bruce Moskowitz, Isaac Perlmutter, and Marc Sherman (collectively, private citizens)—and others in relation to five activities or decisions, hereafter referred to as initiatives, that VA undertook including VA's negotiations for a contract for an electronic health record system with Cerner Government Services, Inc.; the development of mobile applications to help veterans access health records; implementation of a medical device registry summit; activities on veterans' suicide prevention and mental health awareness; and VA senior-level personnel decisions. We found that the interactions between VA officials and the three private citizens took place between 2016 and 2018. Our analysis shows that the time frames for the interactions between the private citizens and VA officials varied by initiative and former and current VA officials we spoke with had varying assessments of the impact the citizens had on VA initiatives. This correspondence describes the various interactions on these initiatives. Further, it describes the mode (e.g., email, phone, or in-person meeting), frequency, timing, and content of these interactions as well as their common themes. Finally, the correspondence describes the views of current and former VA officials and the private citizens in terms of the roles that the private citizens played in VA decision-making on these five initiatives. Why GAO Did This Study In a January 2017 news conference, then President-elect Trump acknowledged VA's challenges managing and overseeing its operations and stated that he and VA would consult business executive Isaac Perlmutter and other private citizens to help address these issues. The involvement of private citizens in VA activities has raised questions about the extent to which the private citizens had an impact on VA decision-making. GAO was asked to review issues related to the involvement of certain private citizens in VA activities and decision-making. This correspondence provides information on the interactions three private citizens—Bruce Moskowitz, Isaac Perlmutter, and Marc Sherman—had with VA related to five VA decisions or activities that VA undertook between 2016 and 2018. GAO reviewed VA documents including 223 email exchanges between private citizens and VA officials, and VA officials' calendar appointments and travel records, among other things. GAO also interviewed and received written responses from current and former VA officials, private citizens, and their legal representatives. For more information, contact A. Nicole Clowers at (202) 512-7114 or clowersa@gao.gov. Mon, 04 May 2020 00:00:00 -0400