Medicaid is jointly financed by the federal government and the states. States incur Medicaid costs by making payments to service providers (e.g., for doctor visits) and performing administrative activities (e.g., making eligibility determinations), and the federal government reimburses states for a share of these costs. The federal government's share of a state's expenditures for most Medicaid services is called the federal medical assistance percentage (FMAP). The FMAP varies by state and is inversely related to each state's per capita income. For FY2020, FMAP rates range from 50% (13 states) to 77% (Mississippi). Medicaid is a countercyclical program, which means that the rate of growth for Medicaid enrollment tends to accelerate when the economy weakens and tends to slow when the economy gains strength. During recessions, growth in the unemployment rate results in an increase in the rate of growth for Medicaid enrollment, which increases the rate of growth for Medicaid expenditures at the same time that state revenues decline. Reduced state revenues can make it difficult for states to continue financing their Medicaid program, especially with the recession-related growth in Medicaid enrollment. Federal fiscal relief to states is provided during recessions through adjustments to the FMAP rate because this process for getting federal Medicaid funding to states is already in place. Many states have indicated that past FMAP increases allowed the states to prevent further reductions to their Medicaid programs and other portions of their state budgets. The federal government provided states with temporary FMAP rate increases to provide states with fiscal relief on two past occasions: in response to the 2001 recession through the Jobs and Growth Tax Relief Reconciliation Act of 2003 (JGTRRA; P.L. 108-27 ) and in response to the Great Recession through the American Recovery and Reinvestment Act of 2009 (ARRA; P.L. 111-5 , as amended by P.L. 111-226 ). The JGTRRA FMAP increase provided a 2.95 percentage point increase to FMAP rates for the last two quarters of FY2003 and the first three quarters of FY2004. The ARRA FMAP increase provided an across-the-board increase, along with an unemployment-related increase for eligible states. The ARRA across-the-board increase was a 6.2 percentage point FMAP increase, starting in the first quarter of FY2009 and lasting through the first quarter of FY2011; the increase phased down to 3.2 and 1.2 percentage points for the second and third quarters of FY2011, respectively. Most recently, the Families First Coronavirus Response Act (FFCRA; P.L. 116-127 ) added a temporary Medicaid FMAP increase of 6.2 percentage points beginning January 1, 2020, and continuing through the Coronavirus Disease 2019 (COVID-19) public health emergency period. Although the country had not officially entered into a recession at the time FFCRA was enacted, a recession with significant increases in the unemployment rate was expected in the near term. The recession-related FMAP increases have similar components, but there are differences. Similarities of all three of these recession-related FMAP increases include across-the-board FMAP increases; requirements to maintain Medicaid eligibility standards that are no more restrictive than they were prior to the FMAP increases; and requirements to ensure that states do not increase the percentage that local governments contribute to Medicaid expenditures. However, there are differences in how the recession-related FMAP increases were determined. For instance, the JGTRRA and ARRA FMAP increases included hold-harmless provisions that kept the states' regular FMAP rates from declining, and these increases excluded certain Medicaid expenditures from the FMAP increases. The ARRA FMAP increase had an unemployment-related increase that the JGTRRA and FFCRA increases did not have. Also, the JGTRRA FMAP increase did not have additional requirements for states, but ARRA and FFCRA have differing sets of additional requirements for states to adhere to in order to qualify for the FMAP increases.


Medicaid, a joint federal-state health care financing program, is one of the nation's largest sources of health care coverage for low-income and medically needy individuals. A 2016 report published by the National Governors Association noted that high-expenditure Medicaid beneficiaries typically have poorly managed chronic conditions and a host of unmet social needs that result in potentially preventable use of costly services, such as emergency department visits. The report also noted that identifying and better managing those beneficiaries are key to reducing costs and improving outcomes. GAO was asked to examine state and federal efforts to manage costs and improve care coordination for high-expenditure Medicaid beneficiaries. This report describes (1) approaches selected states used to identify or predict high-expenditure Medicaid beneficiaries; (2) strategies selected states used to manage beneficiaries' health care costs while ensuring quality of care; and (3) resources CMS provided to states to help them identify, predict, or better manage high-expenditure beneficiaries. GAO interviewed officials from CMS, as well as Medicaid officials from a nongeneralizable sample of seven states (Indiana, Nevada, Pennsylvania, South Carolina, South Dakota, Vermont, and Washington) and five MCOs. States were selected for variation in their total Medicaid enrollment, enrollment in Medicaid managed care, percentage of state population living in rural settings, and percentage of state population with disabilities. MCOs were selected based on state suggestions, and varied in terms of whether they operated nationally or on a state or regional basis. GAO previously reported that in fiscal years 2009 through 2011, the most expensive 5 percent of Medicaid beneficiaries accounted for nearly half of the expenditures for all beneficiaries; others have also found that a small percentage of beneficiaries account for a disproportionately large share of Medicaid program expenditures. These high-expenditure beneficiaries are an extremely diverse population with varying needs. GAO found that the seven selected states identified or predicted high-expenditure Medicaid beneficiaries using statistics and other approaches. For example, states used risk scores, which estimate an individual beneficiary's expected health care expenditures relative to the average expenditures for beneficiaries in the group. Other approaches included examining service utilization data to identify statistical outliers and using diagnoses, service utilization and claims expenditure thresholds, or clinical judgment to identify or predict high-expenditure beneficiaries. To manage costs and ensure quality of care for high-expenditure beneficiaries, the seven selected states used care management and other strategies. Care management . All the selected states provided care management—providing various types of assistance such as coordinating care across different providers to manage physical and mental health conditions more effectively—for beneficiaries in their fee-for-service delivery systems. Five of the states also contracted with managed care organizations (MCO) to deliver services for a fixed payment and required the MCOs to ensure the provision of care management services to high-expenditure beneficiaries. Other strategies . Some of the seven selected states used additional strategies to manage care for high-expenditure beneficiaries. For example, Indiana officials described a program to restrict, or “lock in,” a beneficiary who has demonstrated a pattern of high utilization to a single primary care provider, hospital, and pharmacy, if other efforts to change the beneficiary's high utilization were unsuccessful. The Centers for Medicare & Medicaid Services (CMS), which oversees the Medicaid program at the federal level, offered optional tools and other resources to support states' efforts to identify or better manage high-expenditure beneficiaries. For example, CMS officials said states received access to resources and technical assistance on establishing health home programs—which seek to better coordinate care for those with chronic conditions—including how to focus on high-expenditure beneficiaries. CMS officials noted that they supported 23 states' and the District of Columbia's health home programs. CMS also offered several resources that, while not designed specifically to target high-expenditure beneficiaries, have been used to support states in identifying or better managing their care. For example, CMS's Medicaid Innovation Accelerator Program offered targeted technical support to states' Medicaid agencies in building their data analytic capacity as they designed and implemented delivery system reforms, which could be used to identify high-expenditure beneficiaries. Officials in two selected states reported that these tools were beneficial for managing the health care costs associated with high-expenditure beneficiaries. HHS provided technical comments, which GAO incorporated as appropriate.


Medicaid, a joint federal-state health care program, is one of the nation's largest sources of funding for medical and other health-related services for tens of millions of low income and medically needy individuals. In fiscal year 2018, estimated federal and state expenditures for Medicaid were $629 billion. The size and complexity of Medicaid make the program particularly vulnerable to improper payments—including payments made for people not eligible for Medicaid. States have significant flexibility to design and implement their Medicaid programs based on their unique needs. These programs are administered at the state level, overseen at the federal level by CMS, and jointly funded by the states and federal government. The federal government matches most state expenditures for Medicaid services based on a statutory formula. Under the Patient Protection and Affordable Care Act, states have the option to expand their Medicaid programs to cover nearly all adults with incomes at or below 133 percent of the federal poverty level. States that choose to expand their programs receive a higher federal matching rate for the Medicaid expansion enrollees. This testimony will cover improvements needed to ensure accurate eligibility determinations and focuses on (1) CMS's oversight of Medicaid eligibility and related expenditures; (2) CMS's efforts to improve Medicaid data; and (3) other opportunities to improve oversight and ensure appropriate enrollment. This testimony is generally based on GAO findings and recommendations on the Medicaid program issued from 2015 through 2018, and steps taken to address them through September 2019. The Centers for Medicare & Medicaid Services (CMS) has taken steps to improve its oversight of the Medicaid program; however, GAO has identified areas where additional actions could improve program oversight and ensure that only eligible individuals are enrolled in the Medicaid program. These actions include closing gaps in oversight of eligibility determinations and related expenses, improving data, and furthering federal-state collaboration. Gaps in oversight of Medicaid eligibility determinations and related expenses. Since 2014, CMS has not estimated improper payments due to erroneous eligibility determinations; it plans to report these estimates in November 2019. GAO found that for fiscal year 2017 Medicaid expansion enrollees accounted for nearly a quarter of all Medicaid enrollees and federal Medicaid expenditures. GAO's prior work has identified gaps in CMS oversight, which affects the federal match. An accurate determination of eligibility is critical to ensuring that only eligible individuals are enrolled, that they are enrolled in the correct eligibility group, and that states' expenditures are appropriately matched with federal funds for Medicaid enrollees. GAO recommended that CMS conduct reviews of federal Medicaid eligibility determinations to ascertain their accuracy and institute corrective actions where necessary, and revise the sampling methodology for reviewing expenditures for the expansion population. CMS concurred with these recommendations, though has since indicated that it will not revise the sampling methodology. We continue to believe that additional steps are needed to fully implement these recommendations. Better Medicaid data. Improvements in Medicaid data could aid program oversight to ensure that only eligible beneficiaries are enrolled. CMS officials acknowledged the need for improved data and cited the Transformed Medicaid Statistical Information System (T-MSIS) initiative as its primary effort—conducted jointly with states—to improve the collection of Medicaid expenditure and utilization data. According to CMS officials, aspects of T-MSIS are designed to broaden the scope and improve the quality of state-reported data, as well as the data's usefulness to states. GAO made a series of recommendations related to T-MSIS. CMS concurred with the recommendations, but some have not been fully implemented, including expediting the use of T-MSIS data for oversight, and outlining a plan and associated time frames for using the data for oversight. Further federal-state collaboration needed for oversight and appropriate enrollment. GAO has previously reported that collaborative activities between the federal government and the states are important to improving oversight of the Medicaid program. CMS has ongoing efforts to engage state agencies and others through a national Medicaid training program for state officials and partnerships to combat Medicaid fraud. Recently, steps were taken to better enable state auditors to audit states' eligibility determinations to ensure beneficiaries qualify for the Medicaid program and are enrolled in the correct eligibility group. GAO has previously suggested that CMS could leverage the unique qualifications of state auditors and help improve program integrity by further providing state auditors with a substantive and ongoing role in auditing state Medicaid programs.


Medicaid, the joint federal-state program that finances health care coverage for low-income and medically needy individuals, spent an estimated $177.5 billion on hospital care in fiscal year 2017. About a quarter ($46.3 billion) of those hospital payments were supplemental payments—typically lump sum payments made to providers that are not tied to a specific individual's care. States determine hospital payment amounts within federal limits. In fiscal year 2017, DSH payments totaled about $18.1 billion. Beginning in fiscal year 2020, the amount of DSH payments each state can make is scheduled to be reduced. GAO was asked to study Medicaid DSH payments to hospitals. Among other things, GAO examined hospital uncompensated care costs and DSH payments by state Medicaid program and hospital characteristics. GAO analyzed data from the 2014 DSH audits—states' independently audited and certified reports of hospital-level uncompensated care costs and DSH payments—from 47 states and the District of Columbia (48 states). Three states were excluded from the analysis because they either did not make DSH payments or the submitted data were unreliable. The 2014 data were the most recently available audited, hospital-specific, data at the time of GAO's analysis. We provided a draft of this report to HHS for review. HHS provided technical comments, which we incorporated as appropriate. Medicaid disproportionate share hospital (DSH) payments are one type of supplemental payment and are designed to help offset hospitals' uncompensated care costs for serving Medicaid beneficiaries and uninsured patients. Under the Medicaid DSH program, uncompensated care costs include two components: (1) costs related to care for the uninsured; and (2) the Medicaid shortfall—the gap between a state's Medicaid payment rates and hospitals' costs for serving Medicaid beneficiaries. GAO's analysis of hospitals receiving DSH payments showed that in 2014, costs related to care for the uninsured comprised 68 percent of total uncompensated care costs, and the remaining 32 percent was the Medicaid shortfall. Across states, GAO found that total DSH payments varied significantly in 2014. DSH payment levels are generally tied to state DSH spending in 1992 and since 1993 states have been subject to a limit on the amount of federal funding that may be used for DSH payments. Medicaid DSH payments covered 51 percent of the uncompensated care costs. In 19 states, DSH payments covered at least 50 percent of uncompensated care costs. DSH payments comprised about 14 percent of total Medicaid payments, yet wide variation existed. For example, DSH payments comprised about 97 percent of Medicaid payments to DSH hospitals in Maine and 0.7 percent of Medicaid payments to DSH hospitals in Tennessee. Some types of hospitals received a greater proportion of DSH payments relative to their share of total uncompensated care costs. For example, states generally provided more DSH payments to public hospitals (in comparison to private and non-profit hospitals) and teaching hospitals (as compared to non-teaching hospitals) relative to their share of total uncompensated care costs.


Medicare beneficiaries—more than 60 million as of 2019—have a series of decisions to make when selecting their Medicare health and prescription drug coverage. Beneficiaries must first choose between two main options for their Medicare coverage: either original fee-for-service Medicare or MA. Within these two options, beneficiaries have many additional choices, and they are permitted to change their coverage at least annually. These selections can be difficult due to the Medicare program's complexity and can have important implications for beneficiaries' out-of-pocket costs and access to providers. According to CMS, the MPF website is intended to help beneficiaries make informed decisions regarding their health care and prescription drug coverage. However, some stakeholders have raised concerns that beneficiaries experience challenges using MPF to compare their Medicare coverage options. GAO was asked to review MPF. This report examines what is known about the usability of MPF and the completeness of its information. GAO reviewed research and CMS documentation on MPF, and surveyed 51 directors of SHIP offices that have counselors who assist beneficiaries with Medicare decisions. Forty SHIP directors completed the survey, resulting in a 78 percent response rate. GAO also interviewed CMS officials and officials with 13 stakeholder groups, including seven beneficiary advocacy groups. GAO provided a draft of this report to the Department of Health and Human Services. The department provided technical comments, which GAO incorporated as appropriate. The Medicare Plan Finder (MPF) website—a primary resource for comparing Medicare coverage options—is difficult for beneficiaries to use and provides incomplete information, according to stakeholders and research studies. These sources and directors of State Health Insurance Assistance Programs (SHIP) GAO surveyed—who assist beneficiaries with their Medicare coverage choices—reported that beneficiaries struggle with using MPF because it can be difficult to find information on the website and the information can be hard to understand. For example, MPF requires navigation through multiple pages before displaying plan details, lacks prominent instructions to help beneficiaries find information, and contains complex terms that make it difficult for beneficiaries to understand information. In response to GAO's survey, 73 percent of SHIP directors reported that beneficiaries experience difficulty finding information in MPF, while 18 percent reported that SHIP counselors experience difficulty. Stakeholders and SHIP directors reported that MPF provides incomplete estimates of costs under original Medicare, making it difficult to compare original Medicare and Medicare Advantage (MA), the program's private heath plan alternative. Specifically, MPF's plan results pages do not integrate information on Medigap plans. (These plans help cover some of beneficiaries' out-of-pocket costs.) Seventy-five percent of the SHIP directors surveyed reported that the lack of Medigap information in MPF limits the ability of beneficiaries to compare original Medicare to MA. The Centers for Medicare & Medicaid Services (CMS)—the agency that administers MPF—is aware of the difficulities beneficiaries face using MPF and is planning to launch a redesigned website in August 2019. According to CMS, redesigning MPF involves multiple iterations of changes and ongoing user testing, and CMS will know more about how well the redesigned MPF addresses user needs after it is used by beneficiaries.


American Indian and Alaska Native students enrolled in public schools have performed consistently below other students on national assessments from 2005-2019. The JOM program provides academic and cultural supports, through contracts, to meet the specialized and unique educational needs of American Indian and Alaska Native students enrolled in public schools and select private schools. In fiscal year 2019, Interior allocated about $23 million for the JOM program, according to Interior's budget documentation. GAO was asked to review issues related to Interior's JOM program, administered by BIE. This report examines the extent to which BIE (1) has key program information, (2) provides training to JOM contractors, and (3) clearly defines and identifies JOM roles and responsibilities. GAO reviewed relevant federal laws, regulations, and both BIE and JOM contractor documents; analyzed existing data and information on JOM; and interviewed agency officials, five JOM contractors of different types, and two nonprofit organizations selected for their knowledge of the JOM program. The Department of the Interior's (Interior) Bureau of Indian Education (BIE) does not have key information to manage the Johnson-O'Malley (JOM) program which provides supplemental education services to meet the specialized and unique needs of American Indian and Alaska Native students. For example, BIE does not maintain a complete and accurate list of all its JOM contractors, who provide services including targeted academic supports, Native language classes, and cultural activities. In May 2019, BIE began to identify all the contractors, but officials acknowledged that their list is still incomplete, and GAO found problems with the list, such as duplicate entries. Federal internal control standards state that an agency should have relevant, reliable information to run its operations. Maintaining a complete list of contractors would improve BIE's administration of the JOM program. BIE does not provide any training for JOM contractors. For example, BIE does not provide training to contractors on how to effectively manage their JOM programs or meet program requirements. By providing training for contractors, BIE could ensure that contractors understand the program and are equipped to provide services to meet the educational needs of their students. In addition, BIE has not clearly defined the roles and responsibilities or identified the staff needed to effectively administer the JOM program (see figure). For example, when BIE closed a field office in California, staff were not identified to administer the office's contracts, including helping contractors renew their contracts when they expired. Also, BIE has not identified a role for Interior's attorneys in reviewing the contracts and some contractors have types of contracts for which they are not eligible. Further, BIE has not identified staff to conduct consistent program oversight, which is important to mitigating the risk of misuse and abuse of JOM funds. Until all JOM roles and responsibilities have been defined and identified, challenges may persist.


Medicare's physician fee schedule contains over 8,000 billing codes for office visits, surgical procedures, or other services provided to beneficiaries. Some provider groups have concerns that these codes do not sufficiently account for the LCCP-type services they provide to Medicare beneficiaries with complex medical needs. The BBA included a provision that GAO examine billing codes that may be used for LCCP-type services for beneficiaries with a serious or life-threatening illness. GAO identified, among other things, (1) existing Medicare physician fee schedule billing codes that can be used to bill LCCP-type services; and (2) trends in Medicare spending on these services from 2013 through 2017. GAO reviewed Centers for Medicare & Medicaid Services (CMS) billing code manuals and American Medical Association (AMA) code descriptors to identify existing codes containing key components of LCCP-type services; analyzed Medicare Part B claims data from 2013 to 2017 (the most recent available at the time of GAO's review); and interviewed officials from CMS and 19 stakeholders, including the AMA, national physician groups, and other provider groups that had previously given input on the topic to Congress. GAO provided a draft of this report to the Department of Health and Human Services (HHS). In response, HHS provided technical comments, which GAO incorporated as appropriate. The 2018 Bipartisan Budget Act (BBA) defined longitudinal comprehensive care planning (LCCP) as services involving an interdisciplinary team of providers who develop and communicate a care plan to Medicare beneficiaries diagnosed with a serious or life-threatening illness. GAO identified at least 58 billing codes in Medicare's physician fee schedule that could be used by providers to bill for services that cover some or all of the LCCP service components as defined in the 2018 BBA —referred to by GAO as LCCP-type services. The 58 billing codes may be used individually or in combination, depending on a beneficiary's medical needs. Stakeholders representing providers told GAO their members generally use one or a combination of these codes to bill for LCCP-type services. Forty-five of the 58 codes are broadly-defined longstanding codes that can be used for LCCP-type services as well as other services such as the treatment of a specific medical complaint. The remaining 13 codes are more recent narrowly-defined codes introduced starting in 2013 that only cover LCCP-type services. They include transitional care management services introduced in 2013, chronic care management starting in 2015, advance care planning in 2016, and behavioral health integration in 2017. GAO found that overall Medicare spending on LCCP-type services that were billed to the 58 codes increased from $26 billion in 2013 to almost $29 billion in 2017. While narrowly-defined services accounted for a small share of this total spending ($467 million in 2017), spending on these narrowly-defined services such as chronic care management increased rapidly. Moreover, spending growth on narrowly-defined services was driven by increased use of these services rather than increases in reimbursement rates. From 2013 through 2017, more beneficiaries received and more providers billed for narrowly-defined services. The number of Medicare beneficiaries receiving these services grew from about 267,000 to about 2.5 million. The number of providers billing these services grew from about 31,000 to about 100,000.


Medication adherence—that is, taking medications as prescribed—is important because not doing so increases the risk of hospitalization and can result in avoidable medical costs. According to some pharmacy industry groups, medication synchronization may help improve medication adherence, particularly for patients with multiple chronic conditions. More than 40 percent of Medicare beneficiaries had two or more chronic conditions in 2015. Congress included a provision in the Bipartisan Budget Act of 2018 for GAO to review and report on the use of medication synchronization. In this report, GAO examines (1) what is known about the use and potential effects of medication synchronization and (2) steps CMS and selected states have taken to support its use. GAO identified and reviewed 22 peer-reviewed studies on medication synchronization. In addition, GAO interviewed CMS officials and 30 stakeholders to gather a wide range of perspectives on medication synchronization. Among others, GAO interviewed six selected pharmacies and two selected Medicare health plans. GAO also reviewed CMS regulations as well as medication synchronization laws from five selected states that vary by geographic region. GAO provided a draft of this report to the Department of Health and Human Services, which provided technical comments. GAO incorporated these comments, as appropriate. Medication synchronization is a process whereby a pharmacist aligns the refill dates of two or more of a patient's medications to a single day (see figure below). GAO found that no comprehensive national data exist on the extent to which medication synchronization has been used or its potential effects. However, limited information suggests that the use of medication synchronization has increased in recent years and that it may have benefits. According to a study published in the American Journal of Managed Care that examined survey data on retail pharmacies, the number of pharmacies using medication synchronization increased from 3,324 in 2013 to 5,534 in 2014. Most of the studies that GAO identified found positive effects from medication synchronization, primarily on patients. For example, a 2018 study reported a 3 percent improvement in medication adherence among patients using medication synchronization than those who were not. Several stakeholders also identified potential limitations of using medication synchronization. For example, some patients may not be able to afford paying all the copayments for their medications at one time each month, and some patients prefer the social interaction of multiple trips to the pharmacy each month. The Centers for Medicare & Medicaid Services (CMS) issued a regulation and some states enacted laws that may help support the use of medication synchronization. While CMS does not have a formal medication synchronization policy for Medicare, a CMS regulation allows for reduced beneficiary cost sharing (for example, a lower copayment) when the beneficiary receives less than a month's supply of a medication. Similar laws pertain to private health plans that provide prescription drug coverage for patients in the five states GAO selected—Georgia, Illinois, Maine, Texas, and Washington. Such measures support medication synchronization because initially aligning the refill dates of multiple medications may require one or more of these medications to be refilled with a quantity that is less than a month's supply. Officials from CMS and four of the selected pharmacies said that lowering the copayments for these refills reduces the financial burden on patients when they first have their medications synchronized. They noted that requiring full copayments for a shorter supply may have discouraged or prevented patients from using medication synchronization.


Members of Congress, the Administration, and outside groups have expressed concern over long-term projections of deficits and debt levels. The Congressional Budget Office (CBO) has stated that federal deficits and debt held by the public, which are higher than average, are projected to increase sharply over the next 30 years. Some have argued that the current congressional budget process has created, or at least exacerbated, the projected long-term deficit and debt challenges. It has been said that the current process does not encourage or require the consideration of long-term budgetary outcomes. Some argue that the lack of a formal requirement for Congress to consider long-term budget outcomes discourages long-term planning and encourages policy outcomes that are desirable in the short term at the expense of the long-term budget situation. It has therefore been suggested that Congress adopt a long-term budget focus. In considering budget or budget process reform, it may be useful to review current congressional tools that may be used for long-term budgeting. For example, information and data are publicly available that project spending, revenue, deficit, and debt levels in the long term, and in some instances, data evaluating the long-term outlook of specific programs are available. Congressional committees are useful resources for long-term budgeting as they gather information and make policy recommendations on individual programs, as well as the budget as a whole. In addition, Congress is able to develop and consider a multiyear budget plan in the form of a budget resolution. The budget resolution may also trigger the budget reconciliation process, which has been used to make legislative changes addressing long-term budgetary levels. Also, the House and Senate have internal rules that restrict or prohibit consideration of legislation that would have certain long-term budgetary effects (e.g., the PAYGO rule and the long-term deficit rule). And lastly, there are laws that restrict or prohibit the enactment of budgetary legislation that would have certain long-term budgetary effects (such as 10-year discretionary spending limits and statutory PAYGO).


Microelectronics (see figure) form the basis of nearly all electronic products, including nuclear weapons. U.S. nuclear weapons use a unique supply of “strategic radiation-hardened” microelectronics that must function properly when exposed to high levels of radiation. NNSA's facilities at Sandia are the only source for these unique microelectronics, and the age of the facilities may pose significant risk to NNSA's capability after 2025. A Senate committee report accompanying the National Defense Authorization Act for Fiscal Year 2019 included a provision for GAO to review NNSA's strategic radiation- hardened microelectronics activities. This report (1) describes NNSA's actions over the past decade to sustain existing facilities and identify future alternatives; and (2) examines NNSA's ongoing approach to managing its microelectronics activities and the extent to which this approach incorporates key management controls. GAO reviewed documents and interviewed officials and contractor representatives from NNSA and Sandia, toured Sandia's microelectronics facilities, and reviewed NNSA program and project management controls. Over the past decade, the Department of Energy's (DOE) National Nuclear Security Administration (NNSA) completed several actions to sustain the condition of its existing microelectronics facilities at Sandia National Laboratories (Sandia), which are NNSA's only source for producing strategic radiation- hardened microelectronics that can operate in environments with extreme exposure to radiation. In particular, during fiscal years 2012 through 2019, NNSA carried out a multiyear, $150-million effort at Sandia to replace or refurbish infrastructure and equipment in its primary microelectronics production facility to ensure continued operations through 2025. While NNSA was working with Sandia to sustain current facilities, the agency also began identifying and evaluating options for producing microelectronics after 2025, including constructing a new multi-billion dollar production facility at Sandia. However, because of changes to key assumptions, including longer-term viability of existing facilities, NNSA decided in November 2018 not to pursue any of the identified alternatives and instead stated that the agency was going to assess options to sustain its current capability at Sandia. NNSA's ongoing approach to managing its strategic radiation-hardened microelectronics activities includes two key efforts. First, the agency decided in October 2019 to invest about $1 billion over the next 20 years to upgrade and sustain its microelectronics capability at Sandia through 2040. Specifically, NNSA plans to upgrade its production process as well as complete identified infrastructure (such as electrical distribution) and equipment projects. Second, in November 2019 NNSA created and filled a new full-time microelectronics coordinator position that, among other things, will have responsibility for certain aspects of the agency's microelectronics activities, according to agency officials. However, NNSA's approach does not fully incorporate key management controls that NNSA applies to other important activities. For example, DOE and NNSA require their programs and projects to establish an overarching management plan that describes the procedures to define, execute, and monitor a program or project as well as establishing specific requirements in a variety of areas such as cost estimating and performance management. NNSA has not established a similar management plan to oversee and coordinate its microelectronics activities. By incorporating these key management controls, NNSA would have increased assurance that its planned microelectronics activities are clearly defined, efficiently executed, and effectively monitored.


Military families with special needs face unique challenges because of their frequent moves. To assist these families, each Military Service implements its own program, known as EFMP. The National Defense Authorization Act (NDAA) for Fiscal Year 2017 included a provision for GAO to review the Military Services' EFMPs, including DOD's role in providing guidance for these programs. This statement focuses on the extent to which (1) each Military Service provides family support in the continental United States and (2) the Military Services monitor and DOD evaluates assignment coordination and family support. This statement is based on a May 2018 GAO report and updates its three recommendations as of January 2020. For the report, GAO analyzed EFMP guidance and documents; reviewed federal laws; analyzed fiscal year 2016 EFMP data; visited military installations, selected for their large numbers of military-connected students; and interviewed officials responsible for implementing, monitoring, and evaluating the EFMPs. In May 2018, GAO found that variation in support provided to military family members with special medical and educational needs through the Department of Defense's (DOD) Exceptional Family Member Program (EFMP) could lead to potential gaps in assistance. GAO recommended that DOD assess the extent to which each Military Service is developing services plans for each family with special needs and is providing sufficient resources to staff an appropriate number of family support providers, as required. DOD concurred. Services plans are important because they describe the necessary services and support for a family with special needs enrolled in the EFMP as well as during the relocation process, such as when a servicemember is assigned to a new location. In April 2019, DOD reported that the Military Services had adopted a standardized form to use when developing services plans; however, DOD has not yet assessed the extent to which each Military Service is developing these plans. In January 2020, a senior DOD official said that the Department began collecting data related to services plans in the last quarter of 2019. In April 2019 (the most recent update), DOD officials said they were planning to pilot a staffing tool to help the Military Services determine the number of family support providers needed at each installation. However, the pilot is expected to last 2 years before it can be implemented across the Military Services. GAO also found that DOD lacked common performance measures for the EFMP and was unable to compare the program's performance across the Military Services. GAO recommended that DOD develop common performance metrics for the program. DOD concurred, and in April 2019 said that it was still in the process of developing performance metrics for assignment coordination and family support. In January 2020, DOD noted that it had not yet developed guidance regarding use of forms that would help improve its ability to collect common performance measures across the Military Services. Further, GAO found that DOD does not have a process to systemically evaluate the results of each Military Service's monitoring activities. GAO also reported that DOD did not systematically review the results of monitoring activities because it relies on each Military Service to self-monitor. DOD officials said efforts to standardize certification of EFMPs have been unsuccessful because the Military Services cannot agree on a set of standards that can be used across installations. GAO recommended that DOD implement a systematic process for evaluating the results of the Military Services' monitoring activities. DOD concurred with the recommendation, but has not yet fully implemented it.


Misuse and abuse of prescription opioids can lead to overdose and death. According to the Centers for Disease Control and Prevention (CDC), 47,600 overdose deaths in the United States in 2017 involved an opioid. GAO and other federal entities have raised concerns about opioid misuse and abuse in Medicare. The Comprehensive Addiction and Recovery Act of 2016 (CARA) authorized CMS and Medicare plan sponsors to establish voluntary DMPs that may limit access to frequently abused prescription drugs, such as opioids, for Medicare beneficiaries who are identified as being at risk for prescription drug abuse. DMPs will become mandatory in Medicare starting in January 2022. CARA included a provision for GAO to review DMPs under Medicare. This report: 1) describes how Medicare identifies beneficiaries at risk of opioid misuse and abuse and how it attempts to mitigate that risk; and 2) identifies the factors likely to affect the success of Medicare DMPs. GAO reviewed CDC's Guideline for Prescribing Opioids for Chronic Pain , CMS regulations, and other relevant CMS guidance. GAO also interviewed officials from CMS, the five largest Medicare Part D prescription drug plan sponsors, and officials from six other stakeholder organizations representing Medicare plan sponsors, physicians (including pain specialists), pharmacy benefit managers, state Medicaid programs, and patients. Medicare's drug management programs (DMP) identify beneficiaries at risk of opioid misuse or abuse, and attempt to mitigate that risk through the use of case management and coverage limitations. DMPs are overseen by the Centers for Medicare & Medicaid Services (CMS) and voluntarily implemented by Medicare Part D prescription drug plan sponsors (private health plans). CMS established a two-step framework for identifying at-risk beneficiaries under DMPs. First, CMS identifies potentially at-risk beneficiaries based on key factors, such as beneficiaries' daily dosage of opioids and the number of prescribers and pharmacies from which they receive opioids, with higher numbers possibly putting the beneficiary at more risk. Second, Medicare Part D prescription drug plan sponsors' clinicians coordinate the provision of care among prescribers and pharmacists (referred to as case management) to determine if those potentially at-risk beneficiaries are actually at risk. If a patient is deemed to be at risk, coverage limitation tools—such as limiting a beneficiary to a selected prescriber or pharmacy, and implementing point-of-sale restrictions on certain drugs or amounts—can be used to limit the at-risk beneficiary's access to opioids. Beneficiaries have an opportunity to appeal an at-risk designation. None of the five plan sponsors GAO interviewed expressed concerns about beneficiaries not receiving clinically appropriate doses of opioids under the Medicare DMPs. Medicare Part D prescription drug plan sponsors and other stakeholders GAO interviewed reported several factors beyond the case management process that could contribute to the success of DMPs. These factors included communication among sponsors, opioid prescribers, and pharmacies dispensing opioids to reduce potential resistance to participating in DMPs by opioid prescribers or beneficiaries. According to plan sponsors and stakeholders, plan sponsors could communicate with stakeholders to ensure that DMPs are not viewed as a punitive tool by beneficiaries, but rather as tools for keeping them safe. Plan sponsors and stakeholders noted that it is important for plan sponsors to have flexibility in varying coverage limitation features to fit regional and other differences in population groups. They noted that CMS should periodically reassess and adjust the elements of the DMP program where appropriate, to incorporate evidence from the outcomes of the DMP—such as how at-risk beneficiaries are identified, or which drugs are selected as frequently abused drugs. Finally, CMS officials told GAO that they are taking steps to assess the DMPs and gather the information required to make periodic changes to the DMP program. For example, CMS officials plan to analyze data for at-risk beneficiaries that DMPs are required to report to CMS, update their Medicare Part D audit protocol, and obtain feedback from plan sponsors about how the DMPs are working. The Department of Health and Human Services provided technical comments on a draft of this report, which GAO incorporated as appropriate.


Misuse of controlled substances continues to be a serious public health problem in the United States. Most commonly misused controlled substances include opioids (such as oxycodone), which are used to treat pain, and central nervous system depressants (such as diazepam), which are used to treat anxiety and sleep disorders. These types of drugs are commonly prescribed for patients in hospice care. The SUPPORT Act included a provision for GAO to examine disposal of controlled substances in home hospice settings. This report describes selected home hospices' controlled substances disposal practices and the challenges they face in disposing of these substances. GAO reviewed the SUPPORT Act and other related statutory and regulatory provisions. GAO also interviewed officials from the Centers for Medicare & Medicaid Services, the Drug Enforcement Administration, three national hospice trade associations, two national nurse trade associations, 11 state hospice associations, and seven hospices. Hospice care helps patients who are terminally ill maintain their quality of life. Most patients get hospice care at home, which typically includes use of controlled substances, including opioids such as oxycodone, to provide pain relief. When hospice patients die at home, they often leave behind unused controlled substances, which can be diverted and misused by anyone with access to them. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), enacted in 2018, allows employees of qualified hospice programs to dispose of unused controlled substances by collecting and destroying the drugs in patients' homes. In addition, some states had laws allowing hospice employees to dispose of patients' unused controlled substances prior to 2018. Three of the seven hospices GAO contacted operate in states without such laws. Officials from two of these hospices told us their hospices began disposing of patients' controlled substances in their homes following the enactment of the SUPPORT Act in 2018. However, one hospice had not begun disposing of these medications because the state department of health directed it not to do so until a state law granting disposal authority to hospices had been enacted. An official from that hospice said that it continued the practice of leaving the controlled substances in the home and educating family members about how to dispose of the drugs themselves. Hospice officials we spoke to identified best practices for preventing diversion and disposing of controlled substances. Best practices include prescription drug counts performed by hospice employees to determine if controlled substances are being used properly, use of lock boxes to limit access to controlled substances in situations where diversion is suspected to be a risk, and having a witness for the disposal of unused controlled substances. The officials also identified challenges their hospice employees have faced when disposing of controlled substances in patients' homes. Challenges include the cost of certain disposal methods, a lack of a witness to the disposal process, and inconsistencies between state laws and federal law concerning which hospice employees may dispose of controlled substances. The Departments of Justice and Health and Human Services provided technical comments on a draft of this report, which GAO incorporated as appropriate.


More than 2.7 million miles of pipeline transport and distribute natural gas, oil, and other hazardous products throughout the United States. Interstate pipelines run through remote areas and highly populated urban areas, and are vulnerable to accidents, operating errors, and malicious physical and cyber-based attack or intrusion. Pipeline system disruptions could result in commodity price increases or widespread energy shortages. Several federal and private entities have roles in pipeline security. TSA is primarily responsible for the federal oversight of pipeline physical security and cybersecurity. This statement summarizes previous GAO findings related to TSA's management of its pipeline security program. It is based on a prior GAO product issued in December 2018, along with updates as of April 2019 on actions TSA has taken to address GAO's recommendations from the report. To conduct the prior work, GAO analyzed TSA documents, such as its Pipeline Security Guidelines ; evaluated TSA pipeline risk assessment efforts; and interviewed TSA officials, 10 U.S. pipeline operators—a non-generalizable sample selected based on volume, geography, and material transported—and representatives from five pipeline industry associations. GAO also reviewed information on TSA's actions to implement its prior recommendations. The Department of Homeland Security's (DHS) Transportation Security Administration (TSA) has developed and provided pipeline operators with voluntary security guidelines, and also evaluates the vulnerability of pipeline systems through security assessments. However, GAO's prior work, reported in December 2018, identified some weaknesses and made recommendations to strengthen TSA's management of key aspects of its pipeline security program. Pipeline security guidelines . GAO reported that TSA revised its voluntary pipeline security guidelines in March 2018 to reflect changes in the threat environment and incorporate most of the principles and practices from the National Institute of Standards and Technology's (NIST) Framework for Improving Critical Infrastructure Cybersecurity. However, TSA's revisions do not include all elements of the current NIST framework and TSA does not have a documented process for reviewing and revising its guidelines on a regular basis. GAO recommended that TSA implement a documented process for reviewing and revising TSA's Pipeline Security Guidelines at defined intervals. TSA has since outlined procedures for reviewing its guidelines, which GAO is reviewing to determine if they sufficiently address the recommendation. Workforce planning . GAO reported that the number of TSA security reviews of pipeline systems has varied considerably over time. TSA officials stated that staffing limitations within its Pipeline Security Branch have prevented TSA from conducting more reviews. Staffing levels for the branch have varied significantly, ranging from 1 full-time equivalent in 2014 to 6 from fiscal years 2015 through 2018. Further, TSA does not have a strategic workforce plan to help ensure it identifies the skills and competencies—such as the required level of cybersecurity expertise—necessary to carry out its pipeline security responsibilities. GAO recommended that TSA develop a strategic workforce plan, which TSA plans to complete by July 2019. Pipeline risk assessments . GAO identified factors that likely limit the usefulness of TSA's risk assessment methodology for prioritizing pipeline security reviews. For example, TSA has not updated its risk assessment methodology since 2014 to reflect current threats to the pipeline industry. Further, its sources of data and underlying assumptions and judgments regarding certain threat and vulnerability inputs are not fully documented. GAO recommended that TSA update its risk ranking tool to include up-to-date data to ensure it reflects industry conditions and fully document the data sources, assumptions and judgments that form the basis of the tool. As of April 2019, TSA reported taking steps to address these recommendations. GAO is reviewing documentation of these steps to determine if they sufficiently address the recommendations. Monitoring performance . GAO reported that conducting security reviews was the primary means for TSA to assess the effectiveness of its efforts to reduce pipeline security risks. However, TSA has not tracked the status of key security review recommendations for the past 5 years. GAO recommended that TSA take steps to update information on security review recommendations and monitor and record their status, which TSA plans to address by November 2019


More than 2.7 million miles of pipeline transport natural gas, oil, and other hazardous liquids needed to operate vehicles and heat homes, among other things, in the United States. Responsibility for safeguarding these pipelines is shared by TSA, within the Department of Homeland Security (DHS); PHMSA, within the Department of Transportation (DOT); and pipeline operators. TSA oversees the security of all transportation modes, including pipelines. PHMSA oversees pipeline safety. DHS and DOT signed a MOU on their roles across all transportation modes in 2004. In 2006, TSA and PHMSA signed an annex to the MOU (MOU Annex) to further delineate their pipeline security-related responsibilities. The TSA Modernization Act includes a provision for GAO to review DHS and DOT roles and responsibilities for pipeline security. This report addresses, among other things: (1) the extent the MOU Annex delineates TSA's and PHMSA's pipeline security roles and responsibilities; and (2) the extent TSA has communicated federal incident response procedures for pipeline breaches to stakeholders. GAO reviewed the MOU annex and related documents and TSA's Pipeline Security and Incident Recovery Protocol Plan, and interviewed officials from PHMSA, TSA, and four pipeline associations. The memorandum of understanding (MOU) Annex signed by the Transportation Security Administration (TSA) and Pipeline and Hazardous Materials Safety Administration (PHMSA) in 2006 delineates their mutually agreed-upon roles and responsibilities for pipeline security, but has not been reviewed to consider pipeline security developments since its inception. As a result, the annex may not fully reflect the agencies' pipeline security and safety-related activities. Efforts to update the annex were delayed by other priorities. As of June 2019, there are no timeframes for completion. By developing and implementing timeframes for reviewing the MOU Annex and updating it, as appropriate, TSA and PHMSA could better ensure any future changes to their respective roles and responsibilities are clearly delineated and updated on a regular basis. TSA's Pipeline Security and Incident Recovery Protocol Plan, issued in March 2010, defines the roles and responsibilities of federal agencies and the private sector, among others, related to pipeline security incidents. For example, in response to a pipeline incident, TSA coordinates information sharing between federal and pipeline stakeholders and PHMSA coordinates federal activities with an affected pipeline operator to restore service. However, TSA has not revised the plan to reflect changes in at least three key areas: pipeline security threats, such as those related to cybersecurity, incident management policies, and DHS's terrorism alert system. By periodically reviewing and, as appropriate, updating its plan, TSA could better ensure it addresses changes in pipeline security threats and federal law and policy related to cybersecurity, incident management and DHS's terrorism alert system, among other things. TSA could also provide greater assurance that pipeline stakeholders understand federal roles and responsibilities related to pipeline incidents, including cyber incidents, and that response efforts to such incidents are well-coordinated.


More than 40 years after the end of the Vietnam War, unexploded ordnance (UXO) from numerous conflicts, but primarily dropped by U.S. forces over Cambodia, Laos, and Vietnam during the Vietnam War, continues to cause casualties in those countries. Over the past 25 years, the United States has provided a total of over $400 million in assistance for UXO clearance and related activities in those three countries through the Department of Defense (DOD), Department of State (DOS), and United States Agency for International Development (USAID), as well as funding for treatment of victims through USAID and the Leahy War Victims fund. Although casualty numbers have dropped in recent years, no systematic assessment of affected areas has been done, and many observers believe it may still take decades to clear the affected areas. War legacy issues such as UXO clearance and victim assistance may raise important considerations for Congress as it addresses the impact of U.S. participation in conflicts around the world and how the United States should deal with the aftermath of such conflicts. The continued presence of UXO in Southeast Asia raises numerous issues, including appropriate levels of U.S. assistance for clearance activities and victim relief; coordination in efforts among DOD, DOS, and USAID; the implications of U.S. action on relations with affected countries; whether U.S. assistance in Southeast Asia carries lessons for similar activity in other parts of the world, including Iraq and Afghanistan; and, more generally, efforts to lessen the prevalence of UXO in future conflicts. Many observers argue that U.S. efforts to address UXO issues in the region, along with joint efforts regarding other war legacy issues such as POW/MIA identification and Agent Orange/dioxin remediation, have been important steps in building relations with the affected countries in the post-war period. These efforts that have proceeded furthest in Vietnam, where the bilateral relationship has expanded across a wide range of economic and security initiatives. In Cambodia and Laos, where bilateral relations are less developed, UXO clearance is one of the few issues on which working-level officials from the United States and the affected countries have cooperated for years. Although some Cambodians and Laotians view U.S. demining assistance as a moral obligation and the U.S. government has viewed its support for UXO clearance as an important, positive aspect of its ties with the two countries, the issue of UXO has not been a major factor driving the relationships. The Consolidated Appropriations Act, 2019 ( P.L. 116-6 ) provides $196.5 million for "conventional weapons destruction" around the world, including $159.0 million for "humanitarian demining," with $3.85 million appropriated for Cambodia, $30.0 million for Laos, and $15.0 million for Vietnam. The Legacies of War Recognition and Unexploded Ordnance Removal Act ( H.R. 2097 ) would authorize $50 million per year for fiscal years 2020 to 2024 for humanitarian assistance in Cambodia, Laos, and Vietnam to develop national UXO surveys, conduct UXO clearance, and finance capacity building, risk education, and support for UXO victims.


American taxpayers spent at least half a billion dollars in 2017 on financial products—issued by banks, through paid tax return preparers—to help them file taxes and get advances or loans against tax refunds. GAO was asked to review tax-time financial products. Among other things, GAO (1) described market trends and examined IRS data, (2) described characteristics of product users and factors that influence product use, and (3) described product disclosure practices. GAO reviewed fee and product usage data; conducted a multivariate regression analysis to determine user characteristics; and analyzed disclosures of selected providers that are national chains and those of their bank partners. GAO conducted nongeneralizeable undercover visits of nine randomly selected tax preparers in the Washington, D.C. area to understand how they communicate fees and terms to taxpayers. Preparers were selected to ensure a mixture of regulatory jurisdictions, among other factors. GAO reviewed laws, regulations, and guidance on the products, and interviewed IRS and other government officials and a nongeneralizeable selection of product and service providers, tax preparation companies, consumer groups, and academics. Trends in the market for tax-time financial products since 2012 include the decline of refund anticipation loans (short-term loans subject to finance charges and fees), the rise in use of refund transfers (temporary bank accounts in which to receive funds), and the introduction of refund advances (loans with no fees or finance charges). More recent product developments include increased online access to products for self-filers, higher refund advance amounts, the introduction of new products, and for tax year 2019, the reintroduction of fee-based loans. However, GAO identified some limitations in Internal Revenue Service (IRS) data on product use, including over- or under-counting of certain types of products. IRS has not communicated these data issues to users and has not updated guidance to tax preparers on how to report new product use. As a result, data users (including federal agencies and policymakers) have inaccurate information to inform their findings and decision-making. Lower-income and some minority taxpayers were more likely to use tax-time financial products, according to GAO analysis of 2017 data from IRS, the Bureau of the Census, and the Federal Deposit Insurance Corporation. Specifically, taxpayers who made less than $40,000 were significantly more likely to use the products than those who made more. African-American households were 36 percent more likely to use the products than white households. Product users tend to have immediate cash needs, according to studies GAO reviewed. For these users, tax-time financial products generally provide easier access to cash and more cash at a lower cost than alternatives such as payday, pawnshop, or car title loans. GAO's undercover visits with nine tax preparers, its review of selected provider websites, and review of documents obtained from selected banks and tax preparers found disclosures generally followed requirements for disclosing fees. However, disclosure practices by some paid tax preparers may pose challenges for consumers. For example: Preparers in GAO's review generally indicated that they present taxpayers with almost all of the documents with fee information after their tax returns have been prepared and the preparers determined the taxpayers qualified for a tax-time financial product. The timing of these disclosures would pose a challenge for taxpayers looking to compare prices for different providers. During six of nine undercover visits, GAO investigators explicitly requested literature on product fees but were not provided such information. Refund transfer fee information on websites GAO reviewed sometimes was presented only after the tax preparation process started, was in small print, or could be found only after navigating several pages. As a result, taxpayers may face challenges comparing prices.


More than 60 percent of establishments manufacturing drugs for the U.S. market were located overseas in fiscal year 2018. FDA has estimated that about 40 percent of finished drugs and 80 percent of active drug ingredients are manufactured overseas. 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 supply chain, an issue highlighted in GAO's High Risk Series for the last 10 years. 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) and 2016 (GAO-17-143) that FDA was conducting more of these foreign drug inspections, but GAO also reported that FDA may have never inspected many establishments manufacturing drugs for the U.S. market. This statement is based on ongoing work and provides preliminary GAO observations on 1) the number of foreign inspections FDA has conducted, 2) inspection staffing levels, and 3) challenges unique to foreign inspections. For this work, GAO examined FDA data, visited FDA foreign offices in China and India, and interviewed drug investigators based in these offices and in the United States. GAO's preliminary analysis of Food and Drug Administration (FDA) data shows that from fiscal year 2012 through 2016, the number of foreign drug manufacturing establishment inspections increased. From fiscal year 2016 through 2018, both foreign and domestic inspections decreased—by about 10 percent and 13 percent, respectively. Howevever, the total number of foreign inspections surpassed the number of domestic inspections in 2015, and a growing percentage of FDA's foreign inspections (43 percent in 2018) were conducted in China and India, where most establishments that ship drugs to the United States were located. FDA officials attributed the decline, in part, to vacancies among investigators available to conduct inspections. GAO previously noted the vital role that inspections play in FDA's oversight of foreign establishments. FDA has 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. FDA was in the process of 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 faces persistent vacancies among investigators in its foreign offices. FDA investigators identified persistent challenges conducting foreign inspections, raising questions about the equivalence of foreign to domestic inspections. For example, while domestic inspections are almost always unannounced, FDA's practice of preannouncing foreign inspections up to 12 weeks in advance may give manufacturers the opportunity to fix problems. Investigators from FDA's China and India offices do conduct some unannounced inspections, but they are involved in a small percentage of inspections in these countries (27 percent and 10 percent, respectively). Further, FDA continues to rely on translators provided by the foreign establishments being inspected, which investigators said can raise questions about the accuracy of information FDA investigators collect.


Most of the 270 million cars, trucks, and buses on U.S. highways are powered by internal combustion engines using gasoline or diesel fuel. However, improvements in technology have led to the emergence of vehicle electrification as a potentially viable alternative to internal combustion engines. Several bills pending in the 116 th Congress address issues and incentives related to electric vehicles and charging infrastructure. Experience with fully electric vehicles is relatively recent: While a few experimental vehicles were marketed in the United States in the 1990s, the first contemporary all-electric passenger vehicles were introduced in 2010. Since then, newer models have increased the range an electric vehicle can travel on a single charge, and charging stations have become more readily available. These developments have been spurred by a range of government incentives, both in the United States and abroad. Transit buses are the fastest-growing segment of vehicle electrification in China, while in the United States and the European Union, the pace of bus electrification is slower. In the United States, federal incentives for electric passenger vehicle purchases have remained largely unchanged for more than a decade and are based primarily on tax credits for electric vehicle purchases and recharging infrastructure investments, and spending on battery chemistry research to develop less-expensive technologies: The plug-in electric tax credit permits a taxpayer to take a credit of up to $7,500 for each vehicle that can be recharged from the electricity grid; it phases out after a manufacturer has sold 200,000 eligible vehicles, a threshold that has been met by Tesla and General Motors. A tax credit for installation of alternative fuel vehicle refueling property expired in 2017; it had allowed a tax credit of $1,000 for equipment installed at a residence and up to $30,000 for business installations. I nvestment in transportation electrification research and development (R&D) , which has led to the gradual reduction in the cost of producing lithium-ion batteries, is administered by the U.S. Department of Energy (DOE) in cooperation with private industry. Although the Trump Administration has recommended large reductions in these programs, Congress has maintained annual funding for sustainable transportation of nearly $700 million in the past two fiscal years. Other programs that directly influence the level of vehicle electrification include the DOE Clean Cities Program, which supports local efforts to reduce fossil fuel-powered transportation, and the Department of Transportation's Alternative Fuel Corridors, which are designated Interstate Highway corridors with a sufficient number of alternative fueling stations, including electric vehicle chargers, to allow alternative fuel vehicles to travel long distances. The federal government also funds municipal transit bus electrification through Federal Transit Administration grants, which may be used for the purchase of all-electric buses. The pace of electrification also may be affected by proposals for less stringent federal standards for Corporate Average Fuel Economy (CAFE) and greenhouse gas emissions from vehicles. Beyond these federal programs, states and electric utilities provide a range of incentives for electrification. The National Conference of State Legislatures reports that 45 states and the District of Columbia offer incentives such as income tax credits for electric vehicle and charger purchases, reduced registration fees, and permitting solo drivers of electric vehicles to use carpool lanes. The California Zero Emission Vehicle program is spurring sales of electric vehicles in 10 states. Utilities can provide incentives to charge during off-peak hours, install public electric charging infrastructure, and utilize vehicle-to-grid (V2G) storage. V2G storage would allow idle vehicle batteries to supply electricity to the grid rather than drawing power from it during peak demand periods.


Most of the civilian federal workforce is covered by one of two retirement systems: (1) the Civil Service Retirement System (CSRS) for individuals hired before 1984 or (2) the Federal Employees' Retirement System (FERS) for individuals hired in 1984 or later. FERS annuities are fully funded by the sum of employee and employer contributions and interest earned by the Treasury bonds held by the Civil Service Retirement and Disability Fund (CSRDF). The federal government makes supplemental payments into the CSRDF on behalf of employees covered by the CSRS because employee and agency contributions and interest earnings do not meet the full cost of the benefits earned by employees covered by that system. The Office of Management and Budget (OMB), in its FY2020 Budget, estimated that in FY2019, obligations from the CSRDF would total $88.4 billion, of which $87.9 billion will represent annuity payments to retirees and survivors. Other outlays consist of refunds, payments to estates, and administrative expenses. Obligations from the fund are projected to increase by 3.7% to $91.7 billion in FY2020, of which $91.3 billion will represent annuity payments. OPM estimated that receipts to the CSRDF from all sources would be $104.4 billion in FY2019 and $108.8 billion in FY2020. The year-end balance of the CSRDF was projected to increase from $915.3 billion at the end of FY2018 to $931.4 billion at the end of FY2019. According to the most recent reporting from the Office of Personnel Management, the total annual income of the CSRDF will increase from $124.9 billion in FY2018 to an estimated $151.0 billion in FY2025 and to $759.9 billion in FY2090. The total expenses of the fund are projected to rise more slowly, increasing from $85.8 billion in FY2018 to an estimated $104.9 billion in FY2025 and to $506.6 billion in FY2090. Consequently, the assets held by the CSRDF also are projected to increase steadily, rising from $947.8 billion in FY2018 to an estimated $1.2 trillion in FY2025 and $10.6 trillion in FY2090. Expenditures from the CSRDF currently are about 40% as large as federal expenditures for the salaries and wages paid to federal employees. Pension expenditures are projected to decline relative to the government's wage and salary expenses, beginning around FY2020. By FY2090, the expenditures of the CSRDF are estimated to be only about 32% as large as the government's expenditures for wage and salary payments to employees. Because CSRS retirement benefits have never been fully funded by employer and employee contributions, the CSRDF has an unfunded liability. The total unfunded liability of the CSRDF was $968.1 billion in FY2017. According to actuarial estimates, the unfunded liability of the CSRDF has already peaked, will steadily decline, and is projected to be eliminated by FY2085. Actuarial estimates indicate that the unfunded liability of the CSRS does not pose a threat to the solvency of the trust fund. There is no point over the next 80 years at which the assets of the Civil Service Retirement and Disability Fund are projected to run out.


Moving to shared services is one way agencies can operate more efficiently. WCFs provide a way to centralize and simplify the funding of shared services. HUD's WCF was established in 2016 to provide HUD offices services on a cost-reimbursable basis. The fund currently finances services from external federal shared service providers—the Departments of the Treasury (Treasury) and Agriculture (USDA). Congress included a provision for GAO to evaluate HUD's WCF. This report examines the extent to which HUD (1) delineated WCF roles and responsibilities and established performance measures, (2) established a transparent and equitable process to recover WCF costs, and (3) developed processes to obtain WCF customer feedback. GAO analyzed agency documentation of WCF management and financial and budget data, using its work on effective WCF management and unexpended balances as criteria. GAO interviewed HUD, Treasury, and USDA officials and conducted three focus groups with WCF customer offices. The Department of Housing and Urban Development's (HUD) Working Capital Fund (WCF) is a self-sustaining fund that collects fees from HUD customers to pay for services needed across the department. HUD's WCF finances human resource (HR) and financial management related services provided by external federal shared service providers. HUD defines most roles and responsibilities in its WCF handbook—the primary reference guide for WCF operations—and has established performance metrics. In addition, in response to GAO's review, HUD updated its handbook in February 2020 to include more current and complete information on existing WCF policies and procedures. However: HUD has not defined who is responsible for identifying and implementing opportunities for achieving efficiencies with service usage, including roles for the business process analyses it periodically conducts. HUD has not assessed the results of the business process analyses, or how those results could contribute to supporting efficient service delivery. Clearly defining WCF roles and assessing the results of its analyses can help HUD better manage the WCF and improve its ability to identify, monitor, and potentially realize cost savings and other efficiencies. GAO found that HUD has a process designed to equitably and transparently recover the WCF's costs for externally provided federal shared services. Prior to February 2020, it had not fully documented existing policies for managing the WCF's unexpended balances and operating reserves. However, HUD has since established its operating reserve policy that reflects all of the ways that the operating reserve can be used, such as to provide pricing stability to customers and ensure continuity of WCF activities in case of funding disruptions. Written documentation of such policies is essential to ensure that funds are managed appropriately and consistently over time. Finally, the WCF Committee has not conducted periodic reviews of shared services to help ensure effective management, strong performance, and customer satisfaction. Officials from both business line offices—the Office of the Chief Human Capital Officer (OCHCO) and Office of the Chief Financial Officer —stated that they use a variety of mechanisms to obtain customer feedback on services. However, WCF customers in two of three focus groups GAO held said that they have not been given opportunities to provide feedback on the overall quality of services they receive, and some participants shared specific concerns with HR services. Officials from OCHCO—the office that oversees HR services—told GAO they are aware of customer concerns, plan to take additional actions to obtain customer feedback, and acknowledged the need for periodic reviews called for in the WCF Committee Charter. Until such reviews are conducted to regularly assess customer satisfaction, HUD will likely lack a comprehensive understanding of the extent to which customer needs are being met and could be missing out on opportunities to improve the performance and management of services for which it pays.


Mozambique, a significant recipient of U.S. development assistance, is a southeastern African country nearly twice the size of California, with a population of 27.9 million people. It achieved rapid growth following a postindependence civil war (1977-1992), but faces a range of political, economic, and security challenges. These include a political scandal over state-guaranteed, allegedly corrupt bank loans received by state-owned firms, which created public debt that the government did not disclose to the International Monetary Fund (IMF). This placed the country's relations with the IMF at risk and has had major negative repercussions for the economy, donor relations, and Mozambique's governance record. Other challenges include unmet development needs, a range of governance shortcomings, organized crime, an ongoing economic slump, and political conflict and violence involving both mainstream political actors and violent extremists. Mozambique is also recovering from two powerful cyclones that hit the country in March and April 2019 (addressed in CRS Report R45683, Cyclones Idai and Kenneth in Southeastern Africa: Humanitarian and Recovery Response in Brief ). Between 2013 and 2016, the country experienced political violence arising from a dispute between the former socialist majority party, FRELIMO, and the leading opposition political party, RENAMO. (The latter is a former armed rebel group that fought the FRELIMO government during the civil war.) Their recent dispute, prompted by years of varied RENAMO grievances linked to FRELIMO's control of the state, led to numerous armed clashes between government and RENAMO forces. In 2019, the two parties signed a permanent cease-fire and a final political and military accord to end their dispute, but they have yet to fully implement those agreements, and the potential for failure remains. Since late 2017, Mozambique also has faced attacks by a violent Islamist extremist group that is active along its far northern coast. The groupâknown as Al Sunnah wa Jama'ah (ASWJ), among other namesâhas killed hundreds, often via beheading. The loan scandal has had far-reaching consequences: It has spurred local and U.S. criminal prosecutions, led some donor governments to suspend aid, undermined the state's credibility, and placed the country in debt distress, reducing its access to credit financing needed to help fund development and government operations. The scandal also is widely seen as contributing to a post-2015 slump in economic growth, which had been rapid for most of the post-civil war period. While that growth expanded the economy and contributed to a decline in extreme poverty, the majority of Mozambicans have remained poor, and while some socioeconomic indicators have improved, the country faces a range of persistent socioeconomic challenges. Development gains have remained limited despite large inflows of foreign assistance and foreign direct investment (FDI). Much of this FDI has financed large industrial projects, many of which have been criticized for being poorly integrated with the broader domestic economyâin which the informal sector and small-scale economic activity prevailâand for generating relatively few jobs or broad reductions in poverty. Mozambique's future may be transformed by the development of large natural gas reserves, discovered in the county's north in 2010. Gas exports are expected to begin in the early to mid-2020s and, together with rising exports of coal, to spur rapid economic growth. The U.S.-based firms Anadarko and ExxonMobil, the latter in partnership with Italy's ENI energy firm, lead international oil company consortia developing the reserves, although a merger involving Anadarko is likely to result in the sale of its Mozambique assets to France's Total SA. While the state may face challenges in effectively governing and managing the large anticipated influx of gas revenue, it has taken some steps to address such challenges. The government plans to establish a sovereign wealth fund to preserve gas income, which it intends to allocate, in part, to infrastructure development, poverty reduction, and economic diversification. U.S.-Mozambican ties are cordial and historically have centered on development cooperation. U.S. assistance, funded at an annual average of $452 million between FY2016 and FY2018, has focused primarily on health programs. Given recent events, U.S. engagement and aid may increasingly focus on the development of economic ties and security cooperation, notably to counter ASWJ, which is active in the area where large-scale gas processing development is underway. For many years, Mozambique received relatively limited congressional attention, but interest in the country may be growing; the country hosted congressional delegations in 2016 and 2018. U.S. humanitarian responses to the recent cyclones have also drawn congressional engagement. Developments in the countryâincluding the rise of violent extremism and prospects for U.S. private-sector investment and U.S. bilateral aid program outcomes in a context in which state corruption poses substantial challengesâcould attract increasing congressional attention in the coming years.


Multiple firms have produced cell-cultured meat as part of their research and development. These products appear likely to become available to consumers in coming years. FDA and USDA are the primary agencies responsible for overseeing the safety of the nation's food supply. However, some stakeholders have expressed concern about the agencies' oversight of cell-cultured meat amidst a fragmented federal food safety oversight system. GAO was asked to review federal oversight of cell-cultured meat. This report (1) describes what is known about methods for commercially producing cell-cultured meat, and (2) examines the extent to which FDA and USDA are collaborating to provide regulatory oversight of cell-cultured meat. GAO conducted a literature review; reviewed documentation from FDA, USDA, and stakeholder groups; analyzed public comments submitted to the agencies; compared agency efforts with leading practices for interagency collaboration; and conducted site visits to selected cell-cultured meat firms. General information about the process of making cell-cultured meat—food products grown from the cells of livestock, poultry, and seafood—is available. However, no company is commercially producing cell-cultured meat. Specific information about the technology being used, eventual commercial production methods, and composition of the final products is not yet known. The general process contains five phases: biopsy, cell banking, growth, harvest, and food processing (see figure). The technology and methods to be used for commercial production are still in development, and producers, regulators, and consumers do not have clarity about many specifics about the process and final product. For example, it is unclear whether production methods and products will use or contain genetically-engineered cells or medications such as antibiotics. The Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) have begun collaborating on regulatory oversight of cell-cultured meat. For example, in 2019, the agencies signed an interagency agreement and created three working groups to carry out the terms of the agreement. However, the agreement and working groups could more fully incorporate practices to enhance and sustain collaboration, such as defining outcomes. For example, the agreement identifies the development of labeling principles as an outcome, but does not describe how the agencies will track and monitor progress toward this outcome, and the working groups identify a lead agency but not members' roles. Also, agency officials said they decided FDA would oversee cell-cultured seafood other than catfish, but they have not formally announced or documented this decision. Developing and updating written guidance and agreements is also a leading practice for interagency collaboration. By fully incorporating leading practices into their efforts to collaborate, the agencies could minimize potential overlap and fragmentation, use resources in a more efficient manner, and better ensure the public and other key stakeholders have clarity about the agencies' oversight responsibilities.


NASA is undertaking a trio of closely related programs to continue human space exploration beyond low-Earth orbit. All three programs (SLS, Orion, and supporting ground systems) are working toward a launch readiness date of June 2020 for the first mission. The House Committee on Appropriations included a provision in its 2017 report for GAO to continue to review NASA's human space exploration programs. This is the latest in a series of reports addressing the mandate. This report assesses (1) how NASA's human space exploration programs are performing relative to cost and schedule commitments, and (2) the extent to which NASA's use of contract award fees is achieving desired program outcomes. To do this work, GAO examined program cost and schedule reports and contractor data, and interviewed officials. This report does not assess the effect, if any, of the government shutdown that ended in January 2019. Due to continued production and testing challenges, the National Aeronautics and Space Administration's (NASA) three related human spaceflight programs have encountered additional launch delays and cost growth. In November 2018, within one year of announcing an up to 19-month delay for the three programs—the Space Launch System (SLS) vehicle, the Orion spacecraft, and supporting ground systems—NASA senior leaders acknowledged the revised date of June 2020 is unlikely. Any issues uncovered during planned integration and testing may push the launch date as late as June 2021. Moreover, while NASA acknowledges about $1 billion in cost growth for the SLS program, it is understated. This is because NASA shifted some planned SLS scope to future missions but did not reduce the program's cost baseline accordingly. When GAO reduced the baseline to account for the reduced scope, the cost growth is about $1.8 billion. In addition, NASA's updated cost estimate for the Orion program reflects 5.6 percent cost growth. The estimate is not complete, however, as it assumes a launch date that is 7 months earlier than Orion's baseline launch date. If the program does not meet the earlier launch date, costs will increase further. Updating baselines to reflect current mission scope and providing complete cost estimates would provide NASA management and Congress with a more transparent assessment of where NASA is having difficulty controlling costs. NASA paid over $200 million in award fees from 2014-2018 related to contractor performance on the SLS stages and Orion spacecraft contracts. But the programs continue to fall behind schedule and overrun costs. Ongoing contract renegotiations with Boeing for the SLS and Lockheed Martin for the Orion program provide NASA an opportunity to reevaluate its strategy to incentivize contractors to obtain better outcomes.


NASA is undertaking a trio of closely related programs to continue human space exploration beyond low-Earth orbit. These three programs include a launch vehicle, a crew capsule, and the associated ground systems at Kennedy Space Center. All three programs are working towards a launch readiness date of June 2020 for the first mission. NASA then plans for these systems to support future human space exploration goals, which include seeking to land two astronauts on the lunar surface. GAO has a body of work highlighting concerns over NASA's management and oversight of these programs. This statement discusses (1) the cost and schedule status of NASA's human spaceflight programs and (2) lessons that NASA can apply to improve its management of its human spaceflight programs. This statement is based on eight reports issued from 2014 to 2019 and selected updates as of September 2019. For the updates, GAO analyzed recent program status reports on program progress. The National Aeronautics and Space Administration's (NASA) three related human spaceflight programs are in the integration and test phase of development, a phase of the acquisition process that often reveals unforeseen challenges leading to cost growth and schedule delays. Since GAO last reported on the status of these programs in June 2019, each program has made progress. For example, the Orion program conducted a key test to demonstrate the ability to abort a mission should a life-threatening failure occur during launch. As GAO found in June 2019, however, the programs continue to face significant schedule delays. In November 2018, within one year of announcing an up to 19-month delay for the three programs—the Space Launch System (SLS) vehicle, the Orion crew spacecraft, and Exploration Ground Systems (EGS)—NASA senior leaders acknowledged the revised launch date of June 2020 is unlikely. In addition, any issues uncovered during integration and testing may push the date as late as June 2021. Moreover, GAO found that NASA's calculations of cost growth for the SLS program is understated by more than 750 million dollars. GAO's past work has identified a number of lessons that NASA can apply to improve its management of its human spaceflight programs. For example, NASA should enhance contract management and oversight to improve program outcomes. NASA's past approach in this area has left it ill-positioned to identify early warning signs of impending schedule delays and cost growth or reap the benefits of competition. In addition, NASA's approach to incentivizing contractors through contract award fees did not result in desired outcomes for the SLS and Orion programs. Further, NASA should minimize risky programmatic decisions to better position programs for successful execution. This includes providing sufficient cost and schedule reserves to, among other things, address unforseen risk. Finally, realistic cost estimates and assessments of technical risk are particularly important at the start of an acquisition program. But NASA has historically provided little insight into the future cost of these human spaceflight programs, limiting the information useful to decision makers.


NFIP has faced significant financial challenges over the years, highlighted by a rise in catastrophic flood events and its $20.5 billion debt to Treasury. Contributing to these challenges are repetitive loss properties—those that have flooded and received a claim payment multiple times. Acquiring and demolishing these properties is one alternative to paying for repeated claims, but questions exist about the cost, efficiency, and effectiveness of this approach. GAO was asked to review FEMA's property acquisition efforts as a means of addressing NFIP's financial challenges. This report examines (1) funding programs available for acquisitions, (2) FEMA's flood mitigation efforts, and (3) factors contributing to NFIP's fiscal exposure. To conduct this work, GAO reviewed FEMA guidance and other documentation; analyzed FEMA data sets related to NFIP policies and claims, repetitive loss properties, and mitigation projects; and interviewed FEMA officials. The Federal Emergency Management Agency (FEMA) administers three grant programs that can fund efforts to mitigate the flood risk of properties insured by the National Flood Insurance Program (NFIP). Together, these three programs funded $2.3 billion in mitigation projects from fiscal years 2014 through 2018. The largest program's funding is tied to federal recovery dollars following presidential disaster declarations, while the other two programs are funded each year through congressional appropriations. States and localities generally must contribute 25 percent of the cost of a mitigation project, but some other federal program funds can be used for that purpose. One example of such a project is property acquisition—purchasing a high-risk property from a willing property owner, demolishing the structure, and converting the property to green space. From 1989 to 2018, FEMA has helped states and localities mitigate more than 50,000 properties; however, the number of nonmitigated repetitive loss properties (generally meaning those that flooded at least twice in 10 years) has grown. Mitigation efforts varied by state. Property acquisition accounted for about 80 percent of mitigated properties nationwide, but, in some states, elevation (raising a structure) was more commonly used. In addition, some states (e.g., Missouri and North Carolina) mitigated a high number of properties relative to their numbers of repetitive loss properties, while others (Florida, New York, Louisiana, and Texas) mitigated a low number. While these efforts can reduce flood risk and claim payments, the federal government's fiscal exposure from NFIP remains high because premium rates do not fully reflect the flood risk of its insured properties. NFIP has experienced several catastrophic flood events in recent years, and the frequency and severity of floods is expected to increase. However, NFIP's premium rates have not provided sufficient revenue to pay claims. As a result, FEMA still owed Treasury $20.5 billion as of March 2020, despite Congress cancelling $16 billion of debt in 2017. As GAO has reported in the past (GAO-17-425), Congress will need to consider comprehensive reform, including mitigation and structural changes to premium rates, to ensure NFIP's solvency.


NFIP's effectiveness depends in part on communities implementing FEMA requirements on floodplain management and post-disaster rebuilding efforts. GAO was asked to undertake a comprehensive evaluation of federal disaster preparedness, response, and recovery efforts. This report examines (1) requirements NFIP communities must meet and challenges they face, (2) FEMA's use of community visits to ensure compliance, and (3) how FEMA oversees community implementation of NFIP requirements for conducting substantial damage assessments. GAO analyzed FEMA data on oversight visits and substantial damage assessments from January 2008 through July 2019. GAO also interviewed floodplain managers in 19 communities in Texas, Florida, and Louisiana, and officials from FEMA and floodplain management organizations. The Federal Emergency Management Agency (FEMA) requires communities participating in the National Flood Insurance Program (NFIP) to adopt FEMA floodplain maps; limit flooding caused by new development; and require that substantially damaged structures meet elevation requirements (see figure). Community floodplain officials cited challenges, including difficulty inspecting buildings after a flood, staff turnover, and adopting new NFIP flood maps. FEMA primarily uses community assistance visits to monitor compliance with NFIP requirements. The visits include evaluations of recent construction. Until 2019, FEMA's goal was to visit all communities considered to be high-risk every 5 years. However, FEMA did not meet this goal in Texas or Florida in 2008–2019 because of a lack of resources. Many high-risk communities received only one visit in this period, and some were not visited at all. Without regular monitoring, FEMA's ability to ensure communities comply with requirements is limited. FEMA and state specialists also are to close out records of these visits in FEMA's tracking system if they find no deficiencies or violations, or when the community has resolved any issues. However, in Florida and Texas GAO found that records for many visits remained open for several years, and FEMA staff were unsure whether this indicated unresolved deficiencies or incomplete recordkeeping. Unreliable recordkeeping hinders FEMA's ability to assess community compliance with NFIP requirements. After a flood, one key community responsibility is to assess whether flood damage on a property was substantial (50 percent or more of the property's value). In such cases, the community must ensure the properties are rebuilt to current NFIP standards. However, FEMA generally does not collect or analyze the results of these assessments, limiting its ability to ensure the process operates as intended. Furthermore, FEMA has not clarified how communities can access NFIP claims data. Such data would help communities target substantial damage assessments after a flood.