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Letter441 G St. N.W.Washington, DC 20548March 2, 2021The Honorable Gary C. PetersChairmanThe Honorable Rob PortmanRanking MemberCommittee on Homeland Security and Governmental AffairsUnited States SenateThe Honorable Carolyn B. MaloneyChairwomanThe Honorable James ComerRanking MemberCommittee on Oversight and ReformHouse of RepresentativesSince the early 1990s, our high-risk program has focused attention ongovernment operations with greater vulnerabilities to fraud, waste, abuse,and mismanagement, or that are in need of transformation to addresseconomy, efficiency, or effectiveness challenges. This effort, supportedby the Senate Committee on Homeland Security and GovernmentalAffairs and by the House of Representatives Committee on Oversight andReform, has brought much needed attention to problems impedingeffective government and costing billions of dollars each year.We have made hundreds of recommendations to reduce thegovernment’s high-risk challenges. Executive agencies either haveaddressed or are addressing many of them and, as a result, progress isbeing made in a number of areas.Congress also continues to take important actions. For example,Congress has enacted a number of laws in recent years that are helpingto make progress on high-risk issues. Financial benefits to the federalgovernment due to progress in addressing high-risk areas over the past15 years (fiscal year 2006 through fiscal year 2020) totaled nearly 575billion or an average of about 38 billion per year. Since our last update in2019, we recorded approximately 225 billion in financial benefits. 11Financialbenefits are based on actions taken in response to our work, such as reducinggovernment expenditures, increasing revenues, or reallocating funds to other areas.Page 1GAO-21-119SP High-Risk Series

Nonetheless, substantial efforts are needed on high-risk areas to achievegreater progress and to address regression in some areas since the lasthigh-risk update in 2019. Tens of billions of dollars in additional benefitsand substantial improvements to the health, well-being, and security ofthe nation would be achieved by fully addressing high-risk issues.Sustained congressional attention and executive branch leadershipremain key to success.The nation faces unprecedented challenges that require the federalgovernment to perform better, be more responsive to the Americanpeople, and achieve greater results. Major issues facing the nationinclude the Coronavirus Disease 2019 (COVID-19) pandemic, economicdownturns and the federal response, race in America, and the federalgovernment’s ability to meet these and other strategic challenges andperform better. 2 Concerted action on High-Risk List areas is vital to buildthe capacity of the federal government and make progress on the currentand emerging challenges facing the nation.We are issuing this year’s High-Risk Report while the federal governmentand the country continue to respond to and recover from the COVID-19pandemic. In addition to catastrophic loss of life, the pandemic hascaused substantial damage to the economy, with many peopletemporarily or permanently unemployed. Moreover, the surge in casesthis winter has overwhelmed the health care system in multiple areasacross the country.The CARES Act includes a provision for us to conduct monitoring andoversight of the federal government’s efforts to prepare for, respond to,and recover from the COVID-19 pandemic. 3 As of January 2021, we hadissued six reports in response to this provision, made 44recommendations to federal agencies, and raised four matters forcongressional consideration to improve the federal government’s2Wealso highlight our work on these issues on our Presidential and CongressionalTransition website at https://www.gao.gov/presidential and congressional transition/.3Pub.L. No. 116-136, § 19010, 134 Stat. 281, 579-81 (2020).Page 2GAO-21-119SP High-Risk Series

response efforts. 4 Agencies agreed with some of these recommendationsand disagreed with others. We maintain that all our recommendations arewarranted. We also have other work under way that addresses thegovernment’s response and recovery activities. 5We urge Congress and the administration to take swift action inimplementing these recommendations and matters. We will continue toprovide ongoing oversight of the federal government’s pandemicresponse and recovery efforts. This report discusses the Department ofHealth and Human Services’ (HHS) leadership and coordination of publichealth emergencies as an emerging issue meriting close attention.COVID-19 has particularly affected several areas on the High-Risk List,including the Decennial Census, Protecting Public Health throughEnhanced Oversight of Medical Products, Improving and ModernizingFederal Disability Programs, Enforcement of Tax Laws, and others. Theeffects of COVID-19 on individual high-risk areas are discussed further inappendix II, where we discuss the status of each high-risk area.This report describes (1) progress made addressing high-risk areas andthe reasons for that progress, and (2) actions that are still needed. It alsoidentifies two new high-risk areas—National Efforts to Prevent, Respondto, and Recover from Drug Misuse and Emergency Loans for SmallBusinesses—and one high-risk area we removed from the list because itdemonstrated sufficient progress in managing risk—Department ofDefense (DOD) Support Infrastructure Management.4GAO,COVID-19: Critical Vaccine Distribution, Supply Chain, Program Integrity, andOther Challenges Require Focused Federal Attention, GAO-21-265 (Washington, D.C.:Jan. 28, 2021); COVID-19: Urgent Actions Needed to Better Ensure an Effective FederalResponse, GAO-21-191 (Washington, D.C.: Nov. 30, 2020); COVID-19: Federal EffortsAccelerate Vaccine and Therapeutic Development, but More Transparency Needed onEmergency Use Authorizations, GAO-21-207 (Washington D.C.: Nov. 17, 2020); COVID19: Federal Efforts Could Be Strengthened by Timely and Concerted Actions,GAO-20-701 (Washington, D.C.: Sep. 21, 2020); COVID-19: Brief Update on InitialFederal Response to the Pandemic, GAO-20-708 (Washington, D.C.: Aug. 31, 2020); andCOVID-19: Opportunities to Improve Federal Response and Recovery Efforts,GAO-20-625 (Washington, D.C.: June 25, 2020).5For more information on our ongoing review of the federal response to the COVID-19pandemic and oversight of related spending, see https://www.gao.gov/coronavirus/.Page 3GAO-21-119SP High-Risk Series

This report is based primarily on reports we had issued as of mid-January2021.How We Identify andRate High-Risk AreasTo determine which federal government programs and functions shouldbe designated high risk, we use our guidance document, DeterminingPerformance and Accountability Challenges and High Risks. 6We consider qualitative factors, such as whether the risk involves public health or safety, service delivery, national security,national defense, economic growth, or privacy or citizens’ rights, or could result in significantly impaired service; program failure; injury orloss of life; or significantly reduced economy, efficiency, oreffectiveness.We also consider the exposure to loss in monetary or other quantitativeterms. At a minimum, 1 billion must be at risk, in areas such as the valueof major assets being impaired; revenue sources not being realized;major agency assets being lost, stolen, damaged, wasted, orunderutilized; potential for, or evidence of, improper payments; andpresence of contingencies or potential liabilities.Before making a high-risk designation, we also consider correctivemeasures planned or under way to resolve a material control weaknessand the status and effectiveness of these actions.Our experience has shown that the key elements needed to makeprogress in high-risk areas are top-level attention by the administrationand agency leaders grounded in the five criteria for removal from theHigh-Risk List, as well as any needed congressional action. The fivecriteria for removal are as follows: Leadership commitment. Demonstrated strong commitment and topleadership support. Capacity. Agency has the capacity (i.e., people and resources) toresolve the risk(s). Action plan. A corrective action plan exists that defines the rootcause and solutions and provides for substantially completing6GAO,Determining Performance and Accountability Challenges and High Risks,GAO-01-159SP (Washington, D.C.: November 2000).Page 4GAO-21-119SP High-Risk Series

corrective measures, including steps necessary to implementsolutions we recommended. Monitoring. A program has been instituted to monitor andindependently validate the effectiveness and sustainability ofcorrective measures. Demonstrated progress. Ability to demonstrate progress inimplementing corrective measures and in resolving the high-risk area.We add clarity and specificity to our assessments by rating each high-riskarea’s progress on the five criteria and use the following definitions: Met. Actions have been taken that meet the criterion. There are nosignificant actions that need to be taken to further address thiscriterion. Partially met. Some, but not all, actions necessary to meet thecriterion have been taken. Not met. Few, if any, actions toward meeting the criterion have beentaken.Figure 1 shows a visual representation of varying degrees of progress ineach of the five criteria for a high-risk area. Each point of the starrepresents one of the five criteria for removal from the High-Risk List andeach ring represents one of the three designations: not met, partially met,or met.An unshaded point at the innermost ring means that the criterion has notbeen met, a partially shaded point at the middle ring means that thecriterion has been partially met, and a fully shaded point at the outermostring means that the criterion has been met. Further, a plus symbol insidethe star indicates the rating for that criterion progressed since our lasthigh-risk update. Likewise, a minus symbol inside the star indicates therating for that criterion declined since our last update.Page 5GAO-21-119SP High-Risk Series

Figure 1: Illustrative Example of High-Risk Progress Criteria RatingsSome high-risk areas are made up of segments or subareas that make upthe overall high-risk area. For example, the high-risk area ProtectingPublic Health through Enhanced Oversight of Medical Products includestwo segments—Response to Globalization and Drug Availability—toreflect two interrelated parts of the overall high-risk area.Multidimensional high-risk areas such as these have separate ratings foreach segment as well as a summary rating of the overall high-risk areathat reflects a composite of the ratings received under the segment foreach of the five high-risk criteria. High-risk areas that are primarily basedon the need for congressional action are not rated on the criteria and donot receive a star graphic.Changes to the 2021High-Risk ListDOD Support Infrastructure Management is being removed from the listdue to the progress that was made in addressing the issue. As we havewith areas previously removed from the High-Risk List, we will continue tomonitor this area to ensure that the improvements we have noted aresustained. If significant problems again arise, we will consider reapplyingthe high-risk designation.As discussed below, we added two areas to the High-Risk List since our2019 update: National Efforts to Prevent, Respond to, and Recover fromDrug Misuse; and Emergency Loans for Small Businesses.Page 6GAO-21-119SP High-Risk Series

In addition to specific areas that we have designated as high risk, otherimportant challenges facing our nation merit continuing close attention.One of these is HHS’s leadership and coordination of public healthemergencies. Another challenge is the management of the federal prisonsystem, including programs that help inmates prepare for a successfulreturn to the community.DOD SupportInfrastructureManagement Removedfrom the High-Risk ListWe are removing the DOD Support Infrastructure Management high-riskarea as DOD has addressed the remaining actions and outcomes fromour 2019 High-Risk Report. For example, under an Office of Managementand Budget (OMB) program to restrict the growth of excess orunderutilized federal properties, DOD contributed to reductions of 68percent of total government-wide office and warehouse space and 75percent of other government-wide properties.DOD also reduced base support costs by implementing our October 2018recommendations to monitor and evaluate use of intergovernmentalsupport agreements between military installations and local governments.In addition, DOD more efficiently utilized installation space through itsreduction of leases, reportedly saving millions of dollars. For example, theArmy reduced its leased footprint in the National Capital Region from apeak of 3.9 million square feet in 2011 to roughly 1 million square feet asof September 2019.DOD is also well positioned for the future to continue improving itssupport infrastructure management as it formally committed in October2019 to implement our remaining recommendations related to future BaseRealignment and Closure rounds. These recommendations included fullyidentifying the cost requirements for military construction, informationtechnology (IT), and relocating personnel and equipment.DOD continues to correct identified real property data discrepancies byissuing new requirements and processes. For example, the Air Force hasestablished a data quality program with a goal of 100 percent accuracy bySeptember 2023, which will help make further improvements to accuracyand completeness of its data moving forward.While we are removing DOD Support Infrastructure from the High-RiskList, it does not mean DOD has addressed all risk within this area. Itremains important that senior leaders continue their efforts to aligninfrastructure with the needs of the forces. Therefore, we will continue toexamine DOD’s efforts, including improving the completeness andPage 7GAO-21-119SP High-Risk Series

accuracy of its real property data as part of our high-risk areas onManaging Federal Real Property and DOD Financial Management.See appendix II for additional detail on this high-risk area.National Efforts to Prevent,Respond to, and Recoverfrom Drug Misuse Addedto the High-Risk ListDrug misuse—the use of illicit drugs and the misuse of prescriptiondrugs—has been a persistent and long-standing public health issue in theUnited States. Ongoing efforts seek to address drug misuse througheducation and prevention, substance use disorder treatment, lawenforcement and drug interdiction, and programs that serve populationsaffected by drug misuse. These efforts involve federal, state, local, andtribal governments as well as community groups and the private sector.Drug misuse represents a serious risk to public health. It has resulted insignificant loss of life and harm to society and the economy. In recentyears, the federal government has spent billions of dollars and hasenlisted more than a dozen agencies to address drug misuse and itseffects.We determined in March 2020 that this issue is high risk. At that time, inconsideration of the challenges from the onset of the COVID-19pandemic, we reported we would be making the high-risk designationeffective in 2021. We also noted that the public health and economiceffects from the COVID-19 pandemic could fuel contributing factors ofdrug misuse, such as unemployment.In December 2020, the Centers for Disease Control and Prevention(CDC) reported, based on its analysis of National Center for HealthStatistics provisional data, that the largest recorded increase of drugoverdose deaths occurred during the 12-month period ending in May2020. In particular, CDC reported a concerning acceleration of theincrease in drug overdose deaths from March 2020 to May 2020,coinciding with the implementation of widespread mitigation measures forthe COVID-19 pandemic.Even before the COVID-19 pandemic, rates of drug misuse hadincreased from 2002 through 2019, and the rates of drug overdosedeaths had also generally increased nationally from the early 2000sthrough 2019. Although the rate of drug overdose deaths in 2018decreased compared to 2017, this improvement was reversed in 2019, asshown in figure 2.Page 8GAO-21-119SP High-Risk Series

Figure 2: Rate of Drug Overdose Deaths in the United States, 2002–2019Note: CDC adjusts drug overdose death rates for age and the population size to control for thechanging age distribution and size of the population, and thereby allows comparisons of rates overtime. Data are not yet available for all of 2020. However, in December 2020, CDC reported, based onits analysis of National Center for Health Statistics provisional data, that the largest recorded increaseof drug overdose deaths occurred during the 12-month period ending in May 2020.The Office of National Drug Control Policy (ONDCP) is responsible foroverseeing and coordinating the implementation of U.S. drug controlpolicy, including developing the National Drug Control Strategy (Strategy).ONDCP produced the Strategy in 2019 and 2020, but neither iterationcontained all the elements required by law. For example, the 2020Strategy did not include the required 5-year projection for the NationalDrug Control Program and budget priorities. It also did not includeestimates of federal funding or other resources needed to achieve each ofthe Strategy’s long-range quantifiable goals.Furthermore, in November 2020, we found that the 2020 National DrugControl Assessment, a companion document to the Strategy, did notinclude complete information on performance measures for a number ofprograms related to the Strategy’s prevention goals. Across our body ofwork, we have made recommendations to ONDCP and other NationalDrug Control Program agencies to help ensure that future iterations of theStrategy include all statutorily required elements and to ensure effective,Page 9GAO-21-119SP High-Risk Series

sustained implementation of the Strategy. Agencies have generallyagreed with our recommendations.Our past work also found that the federal government has faced barriersto in

Strategic Human Capital Management Improving Federal Oversight of Food Safety EPA's Process for Assessing and Controlling Toxic Chemicals . Source: GAO. GAO-21-119SP . View GAO -21 119SP. For more information, contact Michelle Sager at (202) 512-6806 or sagerm@gao.gov. Why GAO Did This Study