VA provides nursing home care for veterans whose health needs are extensive enough to require skilled nursing and personal care in an institutional setting. VA provides or pays for the cost of nursing home care for eligible veterans. GAO was asked to examine VA nursing home care. In this report, GAO 1) describes utilization of and expenditures for VA-funded nursing home care, 2) examines VA's use of inspections to assess the quality of nursing home care and its oversight of the process, and 3) examines the information VA publicly provides through its website on the quality of nursing home care. To perform this work, GAO reviewed VA policies and information on inspections and interviewed VA officials. GAO also selected six VA medical centers based on factors such as their participation with CLCs, SVHs, and CNHs and location. For each, GAO interviewed medical center officials and officials from corresponding VA regional offices, CLCs, SVHs, and CNHs. According to the Department of Veterans Affairs (VA), veterans' use of nursing home care increased 3 percent, from an average daily census of 37,687 to 38,880 veterans, from fiscal years 2012 to 2017. VA projects that use will increase 16 percent from fiscal years 2017 to 2022 with the aging of Vietnam War veterans. VA's nursing home expenditures increased 17 percent (8 percent adjusted for inflation), from $4.9 billion to $5.7 billion, from fiscal years 2012 to 2017. During the contract year completed in 2018, VA contractors conducted required inspections of community living centers (CLC) (VA-owned and -operated) and state veterans homes (SVH) (state-owned and -operated) to ensure they complied with quality standards. Selected VA medical centers also completed required annual reviews of Centers for Medicare & Medicaid Services data and conducted optional onsite reviews for community nursing homes (CNH), with which VA contracts. However, VA has opportunities to enhance its oversight. For example, VA did not conduct the quarterly monitoring of contractor performance as stipulated in its contract for CLC inspections from April 2017 to April 2018. VA officials also said they intended to regularly observe contractors conducting inspections to ensure they effectively determine compliance with standards, but have not done so due to competing demands. Officials also said they had performed these observational assessments in the past but were unable to provide documentation of them occurring. Conducting and documenting the quarterly observational assessments would allow VA to identify areas for improvements and to take any needed corrective actions. VA's Access to Care website provides publicly available information about the quality of CLCs and CNHs based on inspections. Veterans and their families can use the website to help inform their decisions on nursing home placement. However, the website does not include any SVH information. Although VA has access to SVH quality information, according to VA officials, they are not required to publicly report it. For some SVHs, VA is the only source for quality care information. Some of the quality information is available locally, but the VA website is an important tool for veterans and their families. Providing SVH information on its website could enhance veterans and their families' ability to evaluate all nursing home options.


VA receives billions of dollars per year to provide health care and disability compensation to promote the wellness of veterans with service-connected conditions. VA studies veterans' health through research and assesses changes in service-connected conditions through its reevaluation process. GAO was asked to review VA's efforts to study and gauge the health outcomes of veterans with service-connected conditions. This report examines the extent to which (1) veterans used VA health care services to treat service-connected conditions, and what is known about their health outcomes; (2) VA uses information on reevaluations to help manage the program; and (3) VA's procedures position it to determine when to conduct a reevaluation. GAO reviewed fiscal year 2018 VA health care data; selected studies; VA data on completed reevaluations from fiscal years 2013-2018; and relevant federal laws, regulations, and program guidance. GAO also interviewed staff at four VA regional offices (selected for variation in claims workload and location) and VA officials at the agency's central office. In fiscal year 2018, about 54 percent of veterans receiving Department of Veterans Affairs (VA) disability compensation had at least one VA outpatient visit to treat an injury or illness that VA deemed was incurred or aggravated during military service (i.e., a service-connected condition). However, the health outcomes of veterans with service-connected conditions, such as changes in the severity of symptoms or the incidence of mortality, are not well understood. Information about health outcomes is central to ensuring veterans' wellness and assessing improvement in their disability status. According to VA researchers GAO spoke with and academic studies GAO reviewed, various challenges have limited research on this population. For example, data reside in different VA systems and use different identifiers for medical conditions, hindering use of the data. While VA has begun to consider ways to analyze health outcomes, it has not yet established a plan for this effort, including the scope, specific activities, and timeframes for addressing the identified research challenges. VA does not glean information from the results of reevaluations to help manage its disability compensation program. Disability reevaluations help VA gauge whether veterans' service-connected conditions have changed, and whether disability compensation should be modified to reflect those changes (see figure). However, VA does not fully use key management information, such as: trends in how frequently certain conditions are reevaluated, including those required by VA regulations to be reevaluated; and outcomes of reevaluation decisions for individual conditions (i.e., whether conditions worsened or improved). Both trend and outcome information could help VA better target its resources toward reevaluating conditions more likely to change. VA recently updated its procedures manual to specify which staff may determine whether a veteran's condition should be reevaluated, but has not clearly defined skill sets and training needed to consistently implement these procedures. Specifically, the updated procedures do not indicate the knowledge, skills, and abilities staff need to determine when to conduct reevaluations. Further, VA has not ensured that training aligns with these needed skillsets. Without improving procedures and training, VA is at risk of conducting unnecessary reevaluations and burdening veterans.


VA spends hundreds of millions of dollars annually to meet the health care needs of about 9 million veterans. In March 2019, GAO added VA Acquisition Management to its High Risk list due to longstanding problems such as ineffective purchasing of medical supplies and lack of reliable data systems. This statement summarizes findings from GAO's 2017 MSPV-NG report and 2019 High Risk report and preliminary observations from two ongoing GAO performance audits to discuss VA's progress in building a more resilient supply chain. For the ongoing work, GAO reviewed VA documentation and interviewed VA officials, and VA medical center staff. Finally, GAO met with senior VA officials on June 5, 2020, to obtain agency views on the new observations GAO discusses in this statement. The Department of Veterans Affairs (VA) has taken some steps in recent years to modernize its processes to acquire hundreds of millions of dollars-worth of medical supplies annually. However, implementation delays for key initiatives, including a new, enterprise-wide inventory management system, limit VA's ability to have an agile, responsive supply chain. Prior to the Coronavirus Disease 2019 (COVID-19) pandemic, in November 2017 and in GAO's High-Risk report in March 2019, GAO reported on weaknesses in VA's acquisition management. For example, GAO reported that VA's implementation of its Medical-Surgical Prime Vendor-Next Generation (MSPV-NG) program—VA's primary means for purchasing medical supplies—lacked an effective medical supply procurement strategy, clinician involvement, and reliable data systems. GAO also found that several of VA's medical supply management practices were not in line with those employed by private sector leading hospital networks. VA is developing another iteration of its MSPV program, called MSPV 2.0, which GAO's preliminary observations show is intended to address some of the shortfalls GAO has identified in its past and ongoing program reviews. In November 2017, GAO recommended that VA develop, document and communicate an overarching MSPV-NG strategy—to include how the program office will prioritize categories of supplies and increase clinician involvement in this process. Preliminary observations from GAO's ongoing work indicate that VA has taken some steps, as it implements MSPV 2.0, to address this priority recommendation. However, GAO's preliminary observations also indicate that the MSPV 2.0 program implementation is delayed and some of these existing program challenges may not be remedied. Based on preliminary observations from GAO's ongoing work, VA's implementation of a new supply and inventory management system is delayed. As a result, VA had to rely on an antiquated inventory management system, and initial, manual spreadsheets to oversee the stock of critical medical supplies at its medical centers. This limited the ability of VA management to have real-time information on its pandemic response supplies, ranging from N95 face masks to isolation gowns, to make key decisions. As of April 2020, VA has an automated tool to manage its reporting process, but the information must be gathered and manually reported by each of VA's 170 medical centers on a daily basis. GAO's preliminary observations also show that in response to COVID-19, VA is using various contracting organizations and mechanisms to meet its critical medical supply needs. These include using national and regional contracting offices to obtain supplies from existing contract vehicles, new contracts and agreements, and the Federal Emergency Management Administration's Strategic National Stockpile to respond to the pandemic.


VA's VR&E program helps veterans with service-connected disabilities obtain and maintain suitable employment. VR&E participants work with vocational counselors to develop career goals and employment plans. However, some veteran service organizations have questioned the consistency with which participants are treated by counselors in developing these plans. GAO was asked to review how VR&E vocational counselors work with participants to select employment plans, and VA's efforts to ensure high quality and consistency. This report examines (1) the factors that vocational counselors considered when developing VR&E participants' plans and how consistently they applied those factors, and (2) the extent to which VA trains and monitors vocational counselors to ensure a consistent, high-quality approach to helping veterans develop plans. GAO analyzed VR&E quality review data from fiscal years 2016 through 2018; reviewed a random, non-generalizable sample of 34 VR&E case files from 2019; reviewed relevant federal laws, regulations, and VA policy; and interviewed VR&E counselors and other program officials. The Department of Veterans Affairs' (VA) Vocational Rehabilitation and Employment (VR&E) counselors in GAO's review generally considered a set of common factors when developing plans to help veterans with disabilities obtain employment, but counselors explained that inconsistent application of those factors likely occurs. These factors included the veteran's disability, his or her interests, and local labor market conditions. The 34 VR&E plans GAO reviewed showed that counselors' generally considered and documented these factors (see table). Counselors in each of the three regional offices GAO visited said that plans are individualized to suit the veteran's needs and as a result will differ because each veteran's case is unique. Nonetheless, these counselors acknowledged that some veterans with similar circumstances likely receive different types of plans given differences in counselor judgment and experience. VA trains and monitors counselors to develop complete VR&E plans but does not assess the consistency of plans across counselors for veterans with similar circumstances. VA's training for VR&E counselors emphasizes that plans should accommodate each veteran's individual needs, abilities, aptitudes, and interests. In designing training for counselors, VA followed principles identified by GAO for strategically developing training. VA monitors the completeness of VR&E plans through national and regional quality reviews that check, among other elements, whether plans have an employment focus and include needed services. However, these quality reviews do not assess the consistency of plans developed by different counselors. VR&E officials explained that the agency has not yet conducted such an analysis because of other priorities, but agreed that it could do so. One of the objectives of VR&E's central office is to provide training and guidance to help ensure consistency among field staff. Assessing consistency across counselors would better position VA to mitigate any unfair differences in plans for similarly-situated veterans.


VA's disability compensation program pays cash benefits to veterans with disabilities connected to their military service. In recent years, veterans who appealed VA decisions on their claims have waited an average of 3 years. The subset of appeals resolved by the Board of Veterans Appeals—a separate VA agency that provides a higher level of appeals review—took on average 7 years to resolve. The Veterans Appeals Improvement and Modernization Act of 2017 makes changes to VA's current (legacy) process, giving veterans options to have their claims reviewed by VA or to appeal directly to the Board. The Act requires VA to submit to Congress and GAO a plan for implementing a new appeals process (which VA submitted in November 2017) and periodic progress reports (which VA submitted in February, May, August, and November 2018). The Act also includes a provision for GAO to assess VA's original plan. In March 2018, GAO found that VA could help ensure successful implementation of appeals reform by addressing gaps in planning and made four recommendations, with which VA agreed. This testimony focuses on the steps VA has taken to address GAO's recommendations, what aspects remain unaddressed, and risks these gaps pose for implementation. For this statement, GAO reviewed VA's updated plans, assessed VA's schedules against best practices, interviewed VA officials and reviewed information they provided about steps taken to implement GAO's recommendations. In a March 2018 report, GAO made four recommendations to address planning gaps in the Department of Veterans Affairs' (VA) November 2017 plan for changing its appeals process for disability compensation claims. Since then, VA has updated its appeals reform plan and taken steps to address aspects of these recommendations, but further steps could enhance its readiness for implementation: Address all legally required elements . VA's November 2017 plan did not address one and only partially addressed four of 22 elements required by the Veterans Appeals Improvement and Modernization Act of 2017 (Act); GAO recommended VA fully address all 22. As of November 2018, VA addressed one element related to projecting productivity and took steps to partially address the other four. VA is still missing information the agency needs to certify that it has the resources needed to successfully implement appeals reform. Articulate plans for performance monitoring and assessment . GAO recommended VA clearly articulate how it will monitor and assess the new appeals process relative to the legacy process, including, for example, specifying timeliness goals for the five new appeals options, and measures for decision accuracy in processing appeals. As of November 2018, VA officials stated their intention to use productivity, timeliness, accuracy, and veteran satisfaction metrics to assess the new versus the legacy appeals processes. However, VA has yet to specify a complete set of goals or measures for monitoring and assessing the relative efficacy of the new process or articulate detailed steps and timeframes for establishing them. Augment master schedule . GAO recommended VA augment its master schedule for appeals reform to reflect sound practices for guiding implementation of reform. Although VA's updated schedule reflected progress since VA's original 2017 plan, it still did not fully meet sound practices for project management. For example, the schedule does not appropriately define the work, activities, and resources necessary to accomplish appeals reform implementation. Without following sound practices, it is unclear whether the schedule poses risks to successful implementation of appeals reform. Address risk fully . GAO recommended that VA's plan more fully address risks in implementing a new appeals process by, for example, testing all appeals options prior to full implementation. As of November 2018, VA took many steps to address risks, although opportunities exist to better assess them. For example, although VA has used lessons learned from tests to update the implementation process, it has not fully tested all aspects nor has it developed mitigation strategies for all identified risks, such as veterans appealing to the Board at higher rates than expected. Until VA takes these remaining steps, it may not have sufficiently accounted for key risks in implementing the new process.


CSBG is one of the key federal programs focused on reducing poverty in the United States. In fiscal year 2019, CSBG provided about $700 million in block grants to states. In turn, states provided grants to more than 1,000 local agencies, which used the funding to provide housing and other services to program participants. HHS is responsible for overseeing states' use of this funding, and states have oversight responsibility for local agencies. GAO was asked to review CSBG program management. This report examines (1) how HHS and selected states conduct their oversight responsibilities and (2) how HHS assesses the effectiveness of the CSBG program. GAO reviewed files for six of the 12 states where HHS conducted onsite compliance evaluations during fiscal years 2016 and 2017, and six states where HHS conducted routine monitoring—five of which were randomly selected. GAO visited three states, selected based on their CSBG funding amount and other factors, to conduct in-depth reviews of their monitoring activities. GAO also reviewed agency documents and interviewed HHS and selected state and local officials. The Department of Health and Human Services (HHS) and the selected states GAO reviewed provided oversight of the Community Services Block Grant (CSBG) program through onsite visits and other oversight activities to assess grant recipients' use of funds against program requirements. Specifically, GAO found: HHS and the selected states conducted required oversight activities. The Community Services Block Grant Act requires HHS to conduct compliance evaluations for several states each year and requires states to conduct onsite visits to local CSBG recipients at least once every 3 years to evaluate whether recipients met various goals. During fiscal years 2016 and 2017, HHS conducted onsite compliance evaluations for 12 states that it deemed most at risk of not meeting CSBG requirements. GAO's visits to three states found that all three had conducted onsite visits to local grantees during the same fiscal years. HHS and the selected states also conducted additional oversight activities. This included routine reviews and quarterly calls. HHS and state monitoring activities primarily identified administrative errors, instances of non-compliance and other issues, which grant recipients took steps to address. For example, a HHS fiscal year 2017 compliance evaluation found that in fiscal year 2015 one state neither implemented procedures to monitor and track findings from a state audit, nor monitored eligible entities as required. HHS uses state outcome data to report on CSBG's national effectiveness, but these data are not aligned with the national program goals to reduce poverty, promote self-sufficiency, and revitalize low-income communities. HHS recently redesigned its' performance management approach to improve its ability to assess whether the CSBG program is meeting these three goals, but several elements of the approach do not align with leading practices in federal performance management. GAO found that HHS's redesigned approach does not demonstrate: How the agency's newly developed national performance measure—intended to provide a count of the number of individuals who achieved at least one positive outcome through CSBG funds—will assess the program in meeting national program goals. How the state outcome data, consisting of more than 100 state and local program measures, relate to CSBG's three national goals. How data collected from state and local agencies will be assessed for accuracy and reliability. Without aligning its redesigned performance management approach with leading practices, OCS cannot properly assess its' progress in meeting CSBG's three national goals.


VA's existing EHR system is antiquated, costly to maintain, and does not fully support VA's need to exchange health records with other organizations, such as the Department of Defense. As a result, VA has undertaken a modernization effort to replace it. As VA prepares to transition from its existing EHR system to a commercial system, it has the opportunity to design standardized work processes to support the delivery of care and ensure information on veterans' care is consistently captured, regardless of site of care. GAO was asked to review VA's EHR system configuration process. This report examines, among other objectives: (1) how VA made EHR system configuration decisions and assessed the compatibility of the commercial EHR system with its work processes; and (2) the effectiveness of VA's decision-making procedures, including ensuring key stakeholder involvement. GAO observed national and local workshop meetings; visited planned initial implementation sites; reviewed documentation on the processes and schedule; and interviewed VA, DOD, and contractor officials. The Department of Veterans Affairs (VA) used a multi-step process to help ensure that its future commercial electronic health record (EHR) system is configured appropriately for, and is compatible with, its clinical work processes. To configure the EHR system, which VA planned to implement initially at the Mann-Grandstaff VA Medical Center, in Spokane, Washington, in July 2020, and at the Puget Sound Health Care System in the fall of 2020, VA established 18 EHR councils comprising VA clinicians, staff, and other experts in various clinical areas and held eight national workshops between November 2018 and October 2019. At these workshops, the councils decided how to design the functionality of the EHR software to help clinicians and other staff deliver care and complete tasks such as administering medication. VA also held eight local workshops at both medical centers to help ensure that the EHR configuration supported local practices. As of March 2020, the EHR councils were continuing to meet to complete configuration decisions. Furthermore, VA plans to hold local workshops in advance of the EHR system implementation at future VA medical facilities. In April 2020, the VA Secretary announced that the department had shifted priorities to focus on caring for veterans in response to the pandemic created by COVID-19. According to program officials, at that time, they paused the implementation of the EHR system and were assessing the impact of the COVID-19 pandemic on VA's planned implementation schedule. GAO found that VA's decision-making procedures were generally effective as demonstrated by adherence to applicable federal internal control standards for establishing structure, responsibility, and authority, and communicating internally and externally, but that VA did not always ensure key stakeholder involvement. Specifically, the councils included a wide range of stakeholders from various geographic regions. However, according to clinicians from the two initial medical facilities for implementation, VA did not always effectively communicate information to stakeholders, including medical facility clinicians and staff to ensure relevant representation at local workshop meetings. As a result, local workshops did not always include all relevant stakeholders. VA has not indicated how it plans to describe these future sessions and define key terms to ensure key stakeholder participation in local workshops. By ensuring that all relevant stakeholders are included, VA will increase the likelihood that it is obtaining input from a wide range of clinicians and staff who will use the EHR system and will increase the likelihood that when it is implemented, the EHR system will effectively support the delivery of care at VA medical centers.


VBA has increased the use of contractors in conducting veterans' disability medical exams. From fiscal year 2012 through mid-September fiscal year 2019, VBA reported that the number of exams completed by contractors rose from about 178,000 to nearly 958,000, which is more than half of all exams completed to date in fiscal year 2019. The remaining exams were completed by medical providers from the Veterans Health Administration. According to VBA, its contracts are worth up to $6.8 billion over 10 years. In light of issues GAO identified with VBA's oversight of contracted examiners in its October 2018 report (GAO-19-13), this testimony provides updates on VA's efforts to 1) improve its oversight of contracted examiners to ensure quality and timely exams and proper invoicing, and 2) ensure that examiners are properly trained. The Veterans Benefits Administration (VBA) has not fully resolved issues regarding how it oversees the quality and timeliness of and invoicing for disability compensation medical exams that are completed by contracted examiners. VBA uses medical exam reports from both VHA and contract examiners to help determine if a veteran should receive disability benefits. GAO reported in October 2018 that VBA was behind in completing quality reviews of contracted exams and did not have accurate information on contractor timeliness. VBA's lack of quality and timeliness data hindered its oversight of contractors' performance. In 2018, GAO made recommendations for VBA to address these issues. VBA has begun to implement GAO's recommendations, but continued action is needed to: Develop and implement a plan for using data from its new medical exam management system to (1) assess contractor timeliness, (2) monitor time spent correcting exams, and (3) verify proper exam invoicing. According to VBA, the agency has not fully implemented its plan for using this new system to resolve challenges with oversight of contractors' performance. For example, due to system issues, VBA has not been able to implement an automated invoicing system it planned to use to validate the accuracy of contractors' invoices. Further, VBA has not yet completed quarterly performance reviews of contracted exams under its new contracts, including any reports for fiscal year 2019. As a result, VBA still is unable to ensure that it is paying contractors the correct amounts based on its contract terms. Monitor and assess aggregate performance data and trends over time to identify higher-level trends and program-wide challenges. VBA officials stated that as the agency makes improvements to the exam management system data it will be able to implement this recommendation, but officials could not provide a target completion date. VBA has taken steps to address issues GAO identified with its oversight of contracted examiner training requirements but has not yet fully addressed them. Having properly trained examiners who can provide high quality exam reports is critical to ensuring that claims processors can make timely and accurate disability determinations for veterans. In 2018, GAO recommended that VBA improve its training oversight by: Implementing a plan to verify that all contracted examiners have completed required training. In response, VBA began conducting random audits of training completed by contracted examiners, but it is still in the process of developing a centralized training system that will collect this information. Such a system could help ensure that contracted examiners complete training and, ultimately, conduct high-quality exams. Collecting information from contractors or examiners on training and use this information to assess training and make improvements. VBA has since developed a feedback tool for examiners to complete following training and plans to use it to improve the training, where needed.


VHA anticipates that it will provide care to more than 7 million veterans in fiscal year 2019. The majority of veterans using VHA health care services receive care in one or more of the 172 medical centers or at associated outpatient facilities. VHA collects an extensive amount of data that can be used to assess and manage the performance of medical centers. Many measures are publicly reported on VA web pages, allowing veterans the ability to compare medical centers' quality of care. GAO was asked to assess VHA's management of medical center performance. This report examines (1) the tools VHA uses to assess medical center performance; (2) VHA's use of medical center performance information to assess medical center directors; and (3) the extent to which VHA has evaluated the effectiveness of the SAIL system. GAO reviewed VHA policies, guidance, and performance information for medical centers and their associated directors. GAO also interviewed officials from VHA as well as from four VA medical centers, selected for variation in performance and geographic location. Department of Veterans Affairs' (VA) Veterans Health Administration (VHA) officials told GAO they primarily use the Strategic Analytics for Improvement and Learning (SAIL) system to assess VA medical center performance. SAIL includes 27 quality measures in areas such as acute care mortality and access to care. VHA officials use SAIL to calculate and assign each medical center an annual star rating of 1 (lowest) to 5 (highest) stars as an assessment of overall quality. For the 146 medical centers that received star ratings in fiscal year 2018, the distribution of star ratings was as follows: 6 percent, 1 star; 24 percent, 2 stars; 38 percent, 3 stars; 19 percent, 4 stars; and 12 percent, 5 stars. Although the specific medical centers within each star-rating category could change from year to year, GAO found that the fiscal year 2018 star ratings for 110 of the 127 medical centers (87 percent) that received star ratings in fiscal year 2013 did not differ by more than 1 star from their fiscal year 2013 rating. Changes in VHA Strategic Analytics for Improvement and Learning Star Ratings, Fiscal Year 2013 Compared to Fiscal Year 2018 GAO found that VHA's appraisal process for assessing medical center director performance relies heavily on medical center performance information, including SAIL. For example, the most heavily weighted appraisal element (40 percent of the overall rating) is made up entirely of medical center performance information. SAIL was evaluated in 2014 and 2015, but VHA has not assessed the recommendations from those evaluations, or taken action on them. The evaluations, which found issues related to the validity and reliability of SAIL and its star ratings for measuring performance and fostering accountability, together included more than 40 recommendations for improving SAIL. The findings are similar to concerns expressed by officials GAO interviewed from VHA, networks, and medical centers about SAIL's effectiveness and how it is currently being used to assess medical center performance. VHA officials told GAO the findings and recommendations of the previous SAIL evaluations were not assessed because the evaluation reports were not widely distributed within VHA due to leadership turnover, as well as attention that was diverted to other concerns such as extensive wait times for medical appointments. Without ensuring that the recommendations resulting from these previous evaluations are assessed and implemented as appropriate, the identified deficiencies may not be adequately resolved, and VHA's ability to hold officials accountable for taking the necessary actions may be diminished.


VHA is the largest single provider of medical care to HIV infected individuals in the nation. In 2018, VAMCs tested approximately 240,000 veterans for HIV and provided HIV care to over 31,000 veterans. Early diagnosis and timely treatment is important for achieving favorable health outcomes and reducing the risk of transmitting the virus to others. The accompanying Joint Explanatory Statement for the Consolidated Appropriations Act, 2018 included a provision for GAO to examine how VAMCs have implemented VHA's HIV screening policy. This report examines (1) approaches that selected VAMCs use to facilitate HIV screening, and (2) the extent to which VHA monitors HIV screening. GAO analyzed VHA documents, including VHA directives and a nongeneralizable sample of 103 veterans' medical records, to understand how providers made decisions and documented actions related to HIV screening. GAO also interviewed VHA and VAMC officials, the latter from five facilities selected based on factors such as the range of HIV prevalence rates. Officials from five selected Department of Veterans Affairs (VA) medical centers (VAMC) reported using various approaches to facilitate human immunodeficiency virus (HIV) screening, which involves three stages. For example, for the first stage of HIV screening (providing HIV tests to consenting veterans), officials told GAO that VAMCs use information technology solutions, such as clinical reminders that prompt providers to offer HIV tests to veterans who have not been tested. These clinical reminders can also prompt providers to offer an HIV test on a repeated, rather than a one-time, basis to veterans with known higher risk factors for acquiring HIV. The Veterans Health Administration (VHA) monitors the first stage of HIV screening by collecting and disseminating data that VAMCs can use to calculate and, if necessary, improve facility HIV testing rates. VHA also collects data on the time frames in which results for eight types of tests are communicated to veterans; these data could indicate how timely test results are being communicated generally (stage two of HIV screening). However, VHA has not effectively communicated the availability of these data to HIV lead clinicians. In addition, VHA does not currently monitor whether VAMCs link veterans who test positive for HIV to care in a timely manner (stage three of HIV screening). VHA officials indicated that they are in the process of building the capacity to collect and disseminate to HIV lead clinicians data on the number of veterans at each VAMC who are linked to HIV care within 30 days, as recommended. However, the time frames for completing these efforts have been extended due to competing priorities, such as implementing required improvements in the diagnosis and treatment of veterans with Hepatitis C. Until VHA improves VAMC staff's access to, or provides them with, these data, it increases its risk that HIV-positive veterans do not receive timely treatment. Such treatment can improve veterans' health outcomes and prevent the transmission of the virus to others.


VHA operates one of the largest health care systems in the nation with an estimate of $81 billion for providing care to over 6.9 million veterans in fiscal year 2019. Recently, VHA has repeatedly requested that Congress provide supplemental funding due to higher-than-expected needs for care. GAO was asked to examine how VHA allocates funds and monitors use of these funds. This report examines (1) VHA's processes for allocating general purpose and specific purpose funds to its VISNs and medical centers and (2) the extent to which VHA monitors the use of these funds. GAO reviewed VHA's processes for allocating funds, analyzed data on allocation levels for fiscal years 2015 through 2019, and reviewed documentation on VHA's processes for allocating funds and monitoring. GAO interviewed officials from VHA; all 18 VISNs; and a non-generalizable sample of five medical centers selected based on size, facility complexity, growth in funding, and geographic variation. The Department of Veterans Affairs' (VA) Veterans Health Administration (VHA) has developed processes for allocating health care funds to its regional Veterans Integrated Service Networks (VISN) and medical centers. Each year, VHA allocates about two-thirds of funds for general patient care—known as general purpose funds—using two, main allocation models. The first model allocates general purpose funds to each VISN and a second model then allocates these funds to the medical centers that report to each VISN. These models are based on patient workload—that is, the number and type of veterans served and the complexity of care provided. VHA allocates its remaining one-third of funds—known as specific purpose funds—to program offices that manage various, specific programs, such as community care and prosthetics. Program offices, in turn, allocate these funds directly to medical centers using different methodologies, including a workload-based model for community care. GAO found the following weaknesses in VHA's processes for allocating funds: VHA's allocation models do not use workload data from the most recently completed fiscal year. For example, the fiscal year 2019 allocation levels determined by the models were based on data from fiscal years 2013 through 2017 but did not include data from fiscal year 2018. The models do not use more recent data because officials believed that doing so would not significantly affect allocations. By not using the most recent data available when it makes final allocations, VHA's allocations may not accurately reflect medical centers' funding needs if they experience workload changes. For example, from fiscal years 2017 through 2018, 34 medical centers had patient workload growth of over 3 percent, and 9 experienced a decline of over 3 percent, which was not reflected in the fiscal year 2019 allocations. VISNs are allowed to make adjustments to allocated funding levels determined by the models and must submit written explanations for doing so according to VHA guidance. However, VHA officials did not adequately review adjustments for fiscal year 2019 to ensure adjustments were documented. Specifically, VHA officials did not provide evidence they sought an explanation for adjustments made by two VISNs that provided no written explanation for their adjustments. Furthermore, GAO also found that VHA guidance does not require VISNs to explain how they determined adjustment amounts and why they made them. Without requiring this information, VHA cannot ensure that these adjustments lead to efficient use of funds. Once VISNs have made adjustments to allocated funding levels and funds are distributed to VISNs and medical centers, VHA uses multiple mechanisms to monitor the balance of funds. Throughout the year, VHA redistributes funds across the VA health care system to address unfunded needs and surpluses that are identified. However, GAO found that VHA does not adequately monitor the redistribution of allocated funds between VISNs and medical centers. VHA does not require VISNs to provide explanations for redistributions and does not review the amount redistributed. As a result, VHA does not know the extent to which redistributions deviate from workload-based allocations and if VISNs and medical centers are operating efficiently.


VHA operates one of the nation's largest health care systems with more than 1,200 sites across the country; however, many facilities were built decades ago and do not align with the agency's current emphasis on outpatient and specialized care. Additionally, new or expanded facilities are needed to accommodate veterans returning from recent conflicts. VHA is constructing and leasing new facilities to respond to these needs. GAO was asked to review VHA's efforts to activate new major medical facilities. This report examines the extent to which VHA is able to compare the actual costs of activation against the estimated costs, among other objectives. GAO analyzed VHA's documentation on estimating activation costs. GAO also interviewed officials and analyzed cost information reported by a non-generalizable selection of eight medical facilities. The facilities had more than $1 million in annual rent or $20 million in construction costs, reported finishing activation in fiscal years 2016 and 2017, and were located in various regions. The Veterans Health Administration (VHA) under the Department of Veterans Affairs (VA) is constructing and leasing new medical facilities, such as outpatient clinics, to better serve and meet the changing needs of veterans. VHA equips and staffs these new facilities in a multi-year process called “activation.” From fiscal year 2012 through 2018, VHA channeled more than $4 billion to major medical facilities undergoing activation, which these facilities could use toward furniture, equipment, and new staffing costs, among other start-up expenses. VHA lacks processes and clear definitions for estimating total activation costs and for comparing actual expenses against these estimates. Specifically, VHA's current cost estimation process does not cover the full duration of activation. Headquarters officials have never compared activation costs against estimated costs because until recently, officials said, VHA lacked the accounting mechanisms to facilitate such comparisons; however, while VHA now possesses these mechanisms, it has not documented the process for how the new information should be used. VHA documentation does not clearly define allowable activation expenses or the appropriate spending timeframes. Local and regional officials expressed confusion over what items could be purchased with activation funds. In addition, local officials held inconsistent beliefs regarding how long expenses could qualify as activation-related. VHA management's priorities include data-driven decision-making. Further, the Office of Management and Budget's guidance states that agencies should compare actual project costs against planned expenses so managers can determine if cost goals are being met. Without processes and clear definitions associated with measuring activation costs, VHA does not have reasonable assurance that it will be able to effectively manage the resources associated with activation.


Veterans rely on long-term care to address a broad spectrum of needs, from providing occasional help around the house to daily assistance with eating or bathing to round-the-clock clinical care. Veterans' eligibility for this care is primarily based on their service-connected disability status, among other factors. Congress included a provision in statute for GAO to review VA's long-term care programs. This report (1) describes the use of and spending for VA long-term care and (2) discusses the challenges VA faces in meeting veterans' demand for long-term care and examines VA's plans to address those challenges. GAO reviewed VA documents, such as strategic planning documents for long-term care programs and analyzed VA utilization and expenditure data for fiscal years 2014 through 2018 (the latest available at the time of the review) and projected data through 2037. GAO also interviewed officials from VA, including officials from VA's GEC, which is responsible for overseeing long-term care programs; and from Veterans Service Organizations. The Department of Veterans Affairs (VA) provides or purchases long-term care for eligible veterans through 14 long-term care programs in institutional settings like nursing homes and noninstitutional settings like veterans' homes. From fiscal years 2014 through 2018, VA data show that the number of veterans receiving long-term care in these programs increased 14 percent (from 464,071 to 530,327 veterans), and obligations for the programs increased 33 percent (from $6.8 to $9.1 billion). VA projects demand for long-term care will continue to increase, driven in part by growing numbers of aging veterans and veterans with service-connected disabilities. Expenditures for long-term care are projected to double by 2037, as shown below. According to VA officials, VA plans to expand veterans' access to noninstitutional programs, when appropriate, to prevent or delay nursing home care and to reduce costs. VA currently faces three key challenges meeting the growing demand for long-term care: workforce shortages, geographic alignment of care (particularly for veterans in rural areas), and difficulty meeting veterans' needs for specialty care. VA's Geriatrics and Extended Care office (GEC) recognizes these challenges and has developed some plans to address them. However, GEC has not established measurable goals for these efforts, such as specific staffing targets for programs with waitlists or specific targets for providing telehealth to veterans in rural areas. Without measurable goals, VA is limited in its ability to address the challenges it faces meeting veterans' long-term care needs.


Virtual currencies, such as bitcoin, have grown in popularity in recent years. Individuals and businesses use virtual currencies as investments and to pay for goods and services. GAO was asked to review IRS's efforts to ensure compliance with tax obligations for virtual currencies. This report examines (1) what is known about virtual currency tax compliance; (2) what IRS has done to address virtual currency tax compliance risks; (3) the extent to which IRS's virtual currency guidance meets taxpayer needs; and (4) whether additional information reporting on virtual currency income could assist IRS in ensuring compliance. GAO reviewed IRS forms and guidance and interviewed officials at IRS, FinCEN, and other federal agencies, as well as tax and virtual currency stakeholders. Taxpayers are required to report and pay taxes on income from virtual currency use, but the Internal Revenue Service (IRS) has limited data on tax compliance for virtual currencies. Tax forms, including the information returns filed by third parties such as financial institutions, generally do not require filers to indicate whether the income or transactions they report involved virtual currency. IRS also has taken some steps to address virtual currency compliance risks, including launching a virtual currency compliance campaign in 2018 and working with other agencies on criminal investigations. In July 2019, IRS began sending out more than 10,000 letters to taxpayers with virtual currency activity informing them about their potential tax obligations. IRS's virtual currency guidance, issued in 2014 and 2019, addresses some questions taxpayers and practitioners have raised. For example, it states that virtual currency is treated as property for tax purposes and that using virtual currency can produce taxable capital gains. However, part of the 2019 guidance is not authoritative because it was not published in the Internal Revenue Bulletin (IRB). IRS has stated that only guidance published in the IRB is IRS's authoritative interpretation of the law. IRS did not make clear to taxpayers that this part of the guidance is not authoritative and is subject to change. Information reporting by third parties, such as financial institutions, on virtual currency is limited, making it difficult for taxpayers to comply and for IRS to address tax compliance risks. Many virtual currency transactions likely go unreported to IRS on information returns, due in part to unclear requirements and reporting thresholds that limit the number of virtual currency users subject to third-party reporting. Taking steps to increase reporting could help IRS provide taxpayers useful information for completing tax returns and give IRS an additional tool to address noncompliance. Further, IRS and the Financial Crimes Enforcement Network (FinCEN) have not clearly and publicly explained when, if at all, requirements for reporting financial assets held in foreign countries apply to virtual currencies. Clarifying and providing publicly available information about those requirements could improve the data available for tax enforcement and make it less likely that taxpayers will file reports that are not legally required.


Water resources development projects undertaken by the Corps—such as those to reduce the risks from coastal storms—historically have taken years or even decades to complete. To implement these projects, the Corps first conducts a feasibility study, which includes an analysis of the federal interest and the costs, benefits, and environmental impacts of a project; such studies can take several years to complete. WRRDA 2014 requires the Corps to, among other things, conduct activities to accelerate the completion of feasibility studies. The act also includes a provision for GAO to assess acceleration reforms. This report examines the extent to which the Corps has (1) addressed the WRRDA 2014 feasibility study acceleration provisions, (2) reviewed the impact of its feasibility study acceleration reforms, and (3) maintained complete milestone data for its studies. GAO reviewed WRRDA 2014 and Corps documents; reviewed 19 feasibility studies subject to the act's acceleration provisions; analyzed data on key milestones; and interviewed Corps officials and stakeholders. The U.S. Army Corps of Engineers has taken steps to address some feasibility study acceleration provisions under the Water Resources Reform and Development Act of 2014 (WRRDA 2014) but not others. For example, to implement a provision related to coordination, the Corps in September 2015 issued guidance emphasizing the importance of early coordination with other federal agencies to avoid delays later in the process. However, the Corps has not taken steps to address other provisions, such as one that calls for the Corps to establish a database to make publicly available information on the status of feasibility studies, citing resource constraints. The Corps does not have a plan to address these other provisions. A plan that includes resource estimates would better position the Corps to address the remaining acceleration provisions. The Corps regularly monitors feasibility studies and has conducted some reviews of its acceleration reforms, such as an analysis that found that some studies were too complex to complete within the agency's timing and cost requirements—i.e., within 3 years and for less than $3 million. However, the Corps has not comprehensively evaluated the reforms' impacts. Corps officials and stakeholders expressed differing views on the reforms' impacts on the costs, time frames, and quality of feasibility studies. For example, many Corps officials GAO interviewed said the reforms' overall goals to reduce studies' cost and time frames were positive, but others raised concerns, such as that the $3 million cost limitation may not be realistic for different geographic areas. Corps officials said they have not conducted a comprehensive impact review in part because they are focused on monitoring ongoing studies. These officials said they see the value in conducting such a review as they complete more studies, but they have not developed a plan to do so. Developing an evaluation plan would help the Corps conduct a timely and effective review. The Corps has not maintained complete milestone data in its central data system for the 19 feasibility studies GAO reviewed (see figure). For example, 12 studies did not include data for one or more milestones. Corps officials said agency policy requires the entry of information on 10 key milestones in the agency's central data system. However, GAO found that the policy only explicitly requires that two of the key 10 milestones be entered into the agency's central data system. Without clarifying its policy to help ensure officials enter data on all milestones in the central data system, the Corps will not have complete data to efficiently monitor the progress of feasibility studies.


Weaknesses identified after the 2007–2009 financial crisis included management weaknesses at large depository institutions and the need for federal regulators (FDIC, Federal Reserve, and OCC) to address the deficiencies in a timely manner. Concerns remain that positive economic results of recent years could mask underlying risk-management deficiencies. This report examined (1) how consistent regulators' revised policies and procedures are with leading risk-management practices, (2) how they applied examination policies and procedures, and (3) trends in supervisory concern data since 2012 and how regulators tracked such data. GAO compared regulators' policies and procedures for oversight against leading practices; compared documents from selected bank examinations for 2014–2016 against regulator's risk-management examination procedures; reviewed aggregate supervisory concern data for 2012–2016; and interviewed regulators and industry representatives. Since 2009, federal banking regulators have revised policies and procedures for use by examiners in supervising depository institutions' management activities (such as those related to corporate governance and internal controls) and for identifying and communicating supervisory concerns. For example, regulators differentiated levels of severity for supervisory concerns and specified when to communicate them to boards of directors at the depository institutions. GAO found that the updated policies and procedures generally were consistent with leading risk-management practices, including federal internal control standards. Examination documents that GAO reviewed showed that examiners generally applied the regulators' updated policies and procedures to assess management oversight at large depository institutions. In particular, for the institutions GAO reviewed, the regulators communicated deficiencies before an institution's financial condition was affected, and followed up on supervisory concerns to determine progress in correcting weaknesses. However, practices for communicating supervisory concerns to institutions varied among regulators and some communications do not provide complete information that could help boards of directors monitor whether deficiencies are fully addressed by management. Written communications of supervisory concerns from the Federal Deposit Insurance Corporation (FDIC) and the Board of Governors of the Federal Reserve System (Federal Reserve) that GAO reviewed often lacked complete information about the cause of the concern and, for the Federal Reserve, also lacked information on the potential consequences of the concern, which in one instance led to an incomplete response by an institution. Communicating more complete information to boards of directors of institutions, such as the reason for a deficient activity or practice and its potential effect on the safety and soundness of operations, could help ensure more timely corrective actions. While supervisory concern data indicated continuing management weaknesses, regulators vary in how they track and use the data. Data on supervisory concerns, and regulators' internal reports based on the data, indicated that regulators frequently cited concerns about the ability of depository institution management to control and mitigate risk. However, FDIC examiners only record summary information about certain supervisory concerns and not detailed characteristics of concerns that would allow for more complete information. With more detailed information, FDIC management could better monitor whether emerging risks are resolved in a timely manner. In addition, the regulators vary in the nature and extent of data they collect on the escalation of supervisory concerns to enforcement actions. FDIC and the Office of the Comptroller of the Currency (OCC) have relatively detailed policies and procedures for escalation of supervisory concerns to enforcement actions, but the Federal Reserve does not. According to Federal Reserve staff, in practice they consider factors such as the institution's response to prior safety and soundness actions. But the Federal Reserve lacks specific and measurable guidelines for escalation of supervisory concerns, relying solely on the judgment or experience of examiners, their management, and Federal Reserve staff, which can result in inconsistent escalation practices.


Cannabidiol (CBD), a compound in the Cannabis sativa plant, has been promoted as a treatment for a range of conditions, including epileptic seizures, post-traumatic stress disorder, anxiety, inflammation, and sleeplessness. However, limited scientific evidence is available to substantiate or disprove the efficacy of CBD in treating these conditions. In the United States, CBD is marketed in food and beverages, dietary supplements, cosmetics, and tobacco products such as electronic nicotine delivery systems (ENDS)âproducts that are primarily regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. Â§Â§301 et seq.). CBD is also the active ingredient in Epidiolex, an FDA-approved pharmaceutical drug. The Regulation of Marijuana and Hemp CBD is derived from the Cannabis sativa plant (commonly referred to as cannabis), which includes both hemp and marijuana. Marijuana is a Schedule I controlled substance under the Controlled Substances Act (CSA, 21 U.S.C. Â§Â§802 et seq.) and is regulated by the Drug Enforcement Administration (DEA). Schedule I substances are subject to the most severe CSA restrictions and penalties. Except for purposes of federally approved research, it is a federal crime to grow, sell, or possess marijuana. Until December 2018, hemp was included in the CSA definition of marijuana and was thus subject to the same restrictions. Legislative changes enacted as part of the 2018 farm bill (Agriculture Improvement Act of 2018, P.L. 115-334 ) removed longstanding federal restrictions on the cultivation of hemp. No longer subject to regulation and oversight as a controlled substance by DEA, hemp production is now subject to regulation and oversight as an agricultural commodity by the U.S. Department of Agriculture (USDA). The 2018 farm bill expanded the statutory definition of what constitutes hemp to include "all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers," as long as it contains no more than a 0.3% concentration of delta-9 tetrahydrocannabinol (THC; 7 U.S.C. Â§1639o). All non-hemp cannabis and cannabis derivativesâincluding marijuana-derived CBDâare considered to be marijuana under the CSA and remain regulated by DEA. Production and Marketing of Hemp Products Legislative changes related to hemp enacted as part of the 2018 farm bill were widely expected to generate additional market opportunities for the U.S. hemp market. However, the farm bill explicitly preserved FDA's authority under the FFDCA and Section 351 of the Public Health Service Act (PHSA, 42 U.S.C. Â§262), including for hemp-derived products. Following enactment of the farm bill, in a December 2018 statement, FDA stated that it is "unlawful under the [FFDCA] to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived." The agency has maintained this view in subsequent communications. Despite FDA's determination, CBD continues to be widely marketed and sold in both food and dietary supplements in the United States. To date, FDA has generally prioritized enforcement against companies and products that pose the greatest risk to consumersâfor example, CBD products claiming to treat Alzheimer's or stop cancer cell growth. In 2014, total U.S. CBD sales were a reported $108 million. In 2018, more than 1,000 companies produced and marketed CBD for the U.S. market, and U.S. CBD sales were estimated at $534 million, according to the Hemp Business Journal . That dollar amount is projected to exceed $1 billion in 2020 and to reach nearly $2 billion in 2022. This amount includes sales from hemp-derived CBD, marijuana-derived CBD (currently a Schedule I controlled substance), and pharmaceutical CBD (currently only Epidiolex). Congressional Interest Congress has expressed concern about the proliferation of CBD products marketed in violation of federal law and has called on FDA to provide guidance on lawful pathways for marketing hemp-derived CBD in food and dietary supplements. In absence of a regulatory framework for hemp-derived CBD, in the explanatory statement accompanying the FY2020 enacted appropriation, Congress directed FDA to issue a policy of enforcement discretion with respect to CBD products that meet the statutory definition of hemp. In addition to the activities directed in the explanatory statement, Congress could also take further legislative action in the future, such as requiring FDA to issue a regulation, under its FFDCA authorities, expressly permitting CBD that meets the definition of hemp to be used as a food additive or dietary supplement. Congress also could amend the FFDCA provisions that FDA has identified as restricting marketing of CBD in food and dietary supplements. In determining whether a legislative approach is appropriate, Congress may consider the potential for adverse health effects and other unintended consequences.


When Congress considers legislation, it takes into account the proposal's potential budgetary effects. Although this information may come from numerous sources, Congress generally relies on estimates provided by the Congressional Budget Office (CBO) and the Joint Committee on Taxation (JCT) when determining whether legislation complies with congressional budgetary rules. Generally, CBO and JCT estimates include projections of the budgetary effects that would result from proposed policy changes, and incorporate anticipated individual behavioral responses to the policy. The estimates, however, do not typically include the macroeconomic effects of those individual behavioral responses that would alter gross domestic product (GDP). In recent decades, however, Congress has sometimes required that JCT and CBO provide estimates that incorporate such macroeconomic effects (effects on overall economic outputâGDP). These estimates are often referred to as dynamic estimates or dynamic scores . Proponents of dynamic estimates have argued that such estimates provide a more accurate assessment of budgetary impact than conventional scoring, and that they can improve Congress's ability to compare competing policy proposals. Proponents argue that dynamic estimates are important for the sake of consistency, and that by not including dynamic effects, the legislative process is biased against policy proposals designed to encourage productive economic activity. Opponents of dynamic estimates argue that estimates of macroeconomic feedback effects are too uncertain to be relied upon as accurate projections of budgetary outcomes. Opponents of dynamic estimates have stated that, with assumptions about the behavioral responses that determine macroeconomic feedback being so uncertain, there is consistency in assuming, for all legislative proposals, that GDP remains the same, regardless of changes in tax or spending policy. Between 1997 and 2018, congressional rules existed that required JCT or CBO to provide dynamic estimates under certain circumstances. These congressional rules and requirements varied, sometimes permitting the creation of dynamic estimates, and sometimes requiring it. During this period, some dynamic estimates provided a range of potential budgetary outcomes, while some included a point estimate . During this period, dynamic estimates were used only for informational purposes, as opposed to being used to determine whether Congress was complying with its budgetary rules. In some cases, published estimates showed wide variation in estimated results depending on the model type and assumptions. While committees and Members continue to have the ability to request that CBO or JCT provide dynamic estimates for certain policies or legislative proposals, for the first time in decades there are no explicit congressional rules or requirements that pertain specifically to the preparation or use of such estimates. If Congress were to reinstitute explicit rules related to dynamic estimates, it may choose to consider many facets of such a potential rule, such as whether a threshold should exist for the creation of such estimates (i.e., should such estimates be provided only for "major legislation"); whether dynamic estimates should be provided for spending as well as revenue proposals; what types of information should be included in such estimates; whether dynamic estimates should be used only for informational purposes, or also for enforcement purposes; and whether additional resources ought to be provided to CBO and JCT so that they might develop greater capacity for providing dynamic estimates.


When Congress enacted the Patient Protection and Affordable Care Act (ACA) in 2010, it required employment-based health plans and health insurance issuers to cover certain preventive health services without cost sharing. Those services, because of agency guidelines and rules, would soon include contraception for women. The "contraceptive coverage requirement," or "contraceptive mandate" as it came to be known, was heavily litigated in the years to follow, and exemptions from the requirement are currently the subject of a pending Supreme Court case. The various legal challenges to the contraceptive coverage requirement primarily concerned (1)Â what types of employers and institutions should be exempt from the requirement based on their religious or moral objections to contraception; (2)Â what procedures the government can require for an entity to invoke a religious-based accommodation; and (3) how much authority federal agencies have to create exceptions to the coverage requirement. As originally formulated, only houses of worship and similar entities were exempt from the requirement, but the government later added an accommodation process for certain religious nonprofit organizations. On June 30, 2014, the Supreme Court held in Burwell v. Hobby Lobby Stores, Inc. that the contraceptive coverage requirement violated federal law insofar as it did not also accommodate the religious objections of closely held, for-profit corporations. The law at issue in that caseâthe Religious Freedom Restoration Act of 1993 (RFRA)âprohibits the federal government from "substantially burden[ing] a person's exercise of religion" except under narrow circumstances. Since Hobby Lobby , the agencies tasked with implementing the ACA have faced numerous hurdles in their attempts to accommodate the interests of sincere objectors while minimizing disruptions to the provision of cost-free contraceptive coverage to women. The lower courts split on whether the accommodation processâwhich required eligible objecting entities to notify their insurers or the government that they qualified for an exemptionâsubstantially burdened the objectors' exercise of religion. Initially, most circuit courts rejected the view that such an accommodation triggered, facilitated, or otherwise made objectors complicit in the provision of coverage, denying their RFRA claims. After consolidating some of these cases for review, the Supreme Court ultimately vacated and remanded the decisions when the government and the objecting parties suggested that a solution might be reached so that the objectors' insurers could provide the required coverage without notice from the objecting parties. Following a change in presidential administration, the implementing agencies reevaluated and reversed their position on the legality of the then-existing accommodation process, concluding that it violated RFRA when applied to certain entities. The agencies opted to automatically exempt most nongovernmental entities that objected to providing coverage for some or all forms of contraception on religious or moral grounds. These expanded exemptions sparked a new round of litigation based on claims that the agencies exceeded their authority under the ACA or violated federal requirements for promulgating new rules. Federal courts, including the U.S. Court of Appeals for the Third Circuit, preliminarily enjoined the government from implementing the expanded exemptions. The Supreme Court is slated to hear arguments on the Third Circuit's decision in May in Little Sisters of the Poor v. Pennsylvania . Meanwhile, the government is largely precluded from relying on the prior accommodation process as a result of a nationwide injunction issued by a federal district court. Little Sisters of the Poor marks the fourth Supreme Court term in six years in which the Court has granted certiorari in a dispute about the federal contraceptive coverage requirement. During that time period, the Executive Departments promulgated six different rules concerning the requirement, a change in presidential administration marked a turning point in the Departments' RFRA calculus, and the Supreme Court underwent its own changes with the appointment of two new Justices. A Supreme Court decision in Little Sisters of the Poor could inform Congress's next steps with regard to the contraceptive coverage requirement. From a legal perspective, Congress has several options for clarifying the requirement's scope, including through amendments to the ACA and RFRA. An opinion in Little Sisters may also provide additional direction to lawmakers and federal agencies asked to accommodate the religious and moral beliefs of regulated entities when enacting or implementing laws of broader applicability.


When acquiring major weapon systems, DOD can choose between several different contract types. One of these is cost-type, under which DOD pays allowable costs incurred by the contractor. Historically, DOD has struggled to manage its major acquisition programs. The result has been billions in cost growth and schedule delays in providing systems to the warfighter. GAO was asked to review DOD's use of cost-type contracts for its major acquisition programs. This report addresses the use of and range of cost and schedule outcomes for cost-type contracts for major weapon system acquisitions, and how military departments share information about contract choice. GAO analyzed government contracting data on obligations by contract type for fiscal years 2011 through 2019 on contracts in DOD's portfolio of major acquisition programs. GAO compared contract types for 21 major acquisition programs with their cost and schedule outcomes; reviewed seven recently awarded cost-type contracts for major acquisition programs, selected to reflect the different military departments and appropriation types; and interviewed contracting officials. To acquire new major weapon systems, such as aircraft, ships, and satellites, the Department of Defense (DOD) uses a variety of contract types including cost-type contracts, under which the government assumes more risk. DOD is required to document its risk assessment in choosing contract types for major programs. Risks assessed can include use of new technologies and stability of system costs and requirements. Once awarded, cost-type contracts have additional reporting requirements to help monitoring of cost and schedule performance. GAO analyzed program cost and schedule outcomes for 21 major acquisition programs, and did not find a clear relationship between these outcomes and contract types used. However, programs that completed certain knowledge-based acquisition practices generally had better cost and schedule outcomes than programs that did not implement those practices. These practices include completing preliminary design review before the start of system development and releasing at least 90 percent of design drawings by critical design review. From fiscal years 2011 through 2019, DOD used cost-type contracts for a small proportion—under one-fifth on average—of obligations for its major acquisition programs. This proportion varied across the military departments (see figure). A change to DOD's peer review process for its largest contract awards reduced a means for sharing best practices and lessons learned about contract choice across the military departments. In 2019, the Office of the Secretary of Defense announced the end of its peer reviews for most competitive procurements above $1 billion. While these contracts will instead be reviewed through the military departments' own processes, DOD currently does not require the departments to collect and share their findings. DOD has an online compendium of peer review findings; however, this was last updated in 2013. Using an existing centralized resource such as the compendium could help contracting officials learn from the experiences of peers across DOD by exposing them to good practices for structuring contracts.


When awarding a contract competitively, agencies can evaluate proposals using a best value, LPTA process that assesses which firm offered the lowest priced technically acceptable proposal. Section 813 of the NDAA for Fiscal Year 2017, as amended, included limitations on DOD's use of the LPTA process and required DOD to revise its acquisition regulation to reflect new criteria for use of the LPTA process. Section 880 of the NDAA for Fiscal Year 2019 required the FAR to be updated with similar requirements for civilian agencies. Sections 813 and 880 also included provisions for GAO to report on the number of instances where the LPTA process was used for contracts exceeding $5 million. This report describes (1) the status of regulatory changes governing the use of the LPTA process; and (2) the extent to which DOD and selected civilian agencies used the LPTA process to competitively award contracts and orders valued over $5 million in fiscal year 2018. GAO interviewed DOD and civilian agency officials involved in revising the DFARS and the FAR. GAO used data from the Federal Procurement Data System-Next Generation to select the top four DOD components and the top five civilian agencies based on the total number of contracts and orders valued at $5 million or more and competitively awarded in fiscal year 2018. Using this data, GAO developed generalizable samples to estimate these components' and agencies' use of the LPTA process in fiscal year 2018. Defense and civilian agencies are in the process of revising acquisition regulations to include criteria and limitations for using the lowest price technically acceptable (LPTA) process, as established under the National Defense Authorization Acts (NDAA) for Fiscal Years 2017 and 2019. While the Acts required revised regulations to be in place within 120 days of enactment, officials involved in revising the regulations stated that this process typically takes at least a year. The Department of Defense (DOD) issued a proposed Defense Federal Acquisition Regulation Supplement (DFARS) rule in December 2018 and expects the rule to be finalized by the end of fiscal year 2019. Officials responsible for revising the Federal Acquisition Regulation (FAR) have drafted a proposed FAR rule. The proposed FAR rule is scheduled to be published in the Federal Register in September 2019. See the figure below for the time frames and actions taken to update the DFARS and the FAR. Based on the results of GAO's generalizable samples, DOD used the LPTA process more frequently than selected civilian agencies in fiscal year 2018 for competitive contracts and orders valued at $5 million or more (see table).


When investigational drugs show promise for treating serious or life-threatening diseases, patients are often interested in obtaining access to them. Congress included a provision in the FDA Reauthorization Act of 2017 for GAO to review actions taken to facilitate access to these drugs. This report describes (1) actions FDA and drug manufacturers have taken to broaden eligibility criteria for clinical trials, (2) actions FDA has taken to facilitate access to investigational drugs outside of clinical trials, and (3) information drug manufacturers have communicated to patients and physicians about access to investigational drugs outside of clinical trials. GAO reviewed laws, regulations, FDA documents, and manufacturer policies and interviewed FDA officials and a non-generalizable selection of 10 manufacturers and 14 other stakeholders (including patient advocacy and physician organizations). The manufacturers were developing drugs to treat serious or life-threatening diseases, and were selected for variation in company size. GAO also reviewed information that a non-generalizable selection of 29 manufacturers communicated through their websites about access to investigational drugs outside of clinical trials. GAO selected manufacturers for variation in the type of serious diseases their investigational drugs were intended to treat, company size, and other factors. HHS provided technical comments on a draft of this report, which GAO incorporated as appropriate. Individuals may access investigational drugs—those not yet approved for marketing in the United States by the Food and Drug Administration (FDA)—by participating in clinical trials conducted by drug manufacturers to test drug effectiveness and safety. FDA has ongoing efforts to help manufacturers identify the circumstances under which they could broaden clinical trial eligibility criteria to include patients who are commonly excluded, such as pediatric patients and patients with impaired liver and kidney function, without compromising study results. FDA issued guidance in March 2019 with recommendations on ways manufacturers could broaden eligibility criteria for cancer clinical trials, when clinically appropriate. In June 2019, FDA issued related guidance that applies to a wider range of clinical trials beyond cancer trials. One of the 10 manufacturers GAO interviewed reported broadening its eligibility criteria to include more patients, such as those with HIV. Another manufacturer has begun reviewing its eligibility criteria and expects to include adolescents, as appropriate, in future studies—a population that has generally been excluded from trials. However, these and two other manufacturers cited challenges in these efforts. One stated that expanding participation to patients who use other medications, for example, could adversely affect a study's ability to identify the effects of the studied drug. Outside of clinical trials, patients with certain medical conditions, who are unable to enroll in a clinical trial, and have no other comparable medical options, may request to obtain access to investigational drugs. This can occur under FDA's expanded access program, or through a 2018 federal law known as “Right to Try.” Under either pathway, a patient can only access the investigational drug if its manufacturer agrees to the request. FDA has taken steps to facilitate access to investigational drugs outside of clinical trials, and most manufacturers in GAO's review communicated information to patients and physicians through their websites about how to access their investigational drugs outside of clinical trials. For example: Since 2017, FDA took steps to simplify its expanded access program to make it easier to participate. In addition, to address concerns raised by manufacturers, FDA clarified guidance on how it would review data resulting from the program. Seven of the 10 manufacturers GAO interviewed viewed the guidance as an improvement. GAO's review of information communicated by 29 manufacturers on their websites found that 23 had policies about accessing investigational drugs outside of clinical trials. At the time of GAO's review, 19 of the 23 stated they would consider individual requests for access, while the other four stated they would not. More than half of the manufacturers stated that if they approve a request, they require additional steps, such as FDA review of the request.


When legislation is introduced in the House or received from the Senate, it is referred to one or more committees primarily on the basis of the jurisdictional statements contained in clause 1 of House Rule X. These statements define the policy subjects on which each standing committee may exercise jurisdiction on behalf of the chamber. The statements themselves tend to address broad policy areas rather than specific departments, agencies, or programs of the federal government. Because comm ittee jurisdiction often is expressed in general policy terms, it is possible for more than one committee to claim jurisdiction over different aspects of a broad subject that may encompass a myriad of specific programs and activities. When referring a measure to more than one committee (a "multiple referral"), the Speaker is directed by clause 2 of House Rule XII to identify a "primary" committee of referral, which is the panel understood to exercise jurisdiction over the main subject of the measure. Rule XII further provides the Speaker with the authority to refer legislation to more than one committee either at the point of introduction (an "initial additional referral"), or after another committee has reported (a "sequential referral"). The Speaker may also divide a measure into its component parts and refer individual pieces to different House panels (a "split referral"), but split referrals are rare in current practice. The Speaker is empowered to place time limits on any referral and always does so in the case of a sequential referral. The Speaker also "may make such other [referral] provision as may be considered appropriate." House rules vest these powers of referral in the Speaker; in practice, the House Parliamentarian makes day-to-day referral decisions acting as the Speaker's nonpartisan and disinterested agent. Although clause 1 of Rule X is the main determinant of House committee jurisdiction, other factors may also influence how legislation is referred, including precedents established by past referrals; agreements between committees outlining their jurisdictional boundaries on new, evolving, or contested policy subjects; and statutes that identify how particular kinds of matters will be referred. The jurisdictions of subcommittees are not explicitly stated in House rules. The jurisdiction of a subcommittee is generally determined by the full committee that created it. If a subcommittee's jurisdiction is not explicitly defined by its parent committee, measures are generally referred to subcommittee or retained by the full committee at the discretion of its chair. A distinction can be made between legislative and oversight jurisdiction. Legislative jurisdiction describes the authority of a committee to receive and report measures to the House. Oversight jurisdiction refers to a committee's ability to review matters within its purview, for instance by conducting hearings and investigations. Legislative jurisdiction is defined in clause 1 of Rule X, while clause 2 of the same rule directs all standing committees to "review and study on a continuing basis the application, administration, execution, and effectiveness of laws and programs addressing subjects within its [legislative] jurisdiction."


When the Food and Drug Administration (FDA) approves a drug for sale in the United States, the approval includes a section entitled "Indications for Use." This section lists the one or more diseases, conditions, or symptoms for which the drug's sponsor (usually the manufacturer) has provided, to FDA's satisfaction, evidence in support of the drug's safety and effectiveness. FDA approval is also based on its review of the drug's dosage, packaging, manufacturing plan, and labeling. Before changing any of those elements, the sponsor must inform, and usually receive permission from, FDA. In essence, FDA regulates all approval and post-approval aspects of a drug product. But FDA traditionally has not regulated the practice of medicine. Physicians, therefore, may prescribe an FDA-approved drug for indications that FDA has not reviewed for safety and effectiveness. Those uses, furthermore, are not addressed in the labeling information regarding, among other things, dosing, warnings about interactions with other drugs, and possible adverse events. How Are Off-Label Prescription Drugs Used? Prescribing for so-called off-label uses can be accepted medical practice, often reflecting cutting-edge clinical expertise. For example, this is the case with oncology drug use, more than half of which is off-label. Off-label prescribing can be a reasonable choice when labeling overlooks certain populationsâfor example, when a drug tested in adults is prescribed to children. A drug may be used off-label when it was tested for the treatment of one disease and prescribed in an attempt to prevent or treat another, when it was tested at one dose and used at higher or lower doses, or when it was tested in an eight-week trial and prescribed for long-term use. Estimates for how common off-label prescriptions are in the United States are hardly precise. Credible researchers have estimated they make up as little as 12% and as much as 38% of doctor-office prescriptions. What Are the Risks of Off-Label Prescriptions? Prescriptions for off-label uses of FDA-approved drugs are made without the benefit of an FDA-reviewed analysis of safety and effectiveness data. Physicians may resort to such prescribing to take advantage of new ideas and treatment approaches when available information to support them is inadequate. However, despite the potential risks associated with off-label uses, efforts to prohibit such uses might hurt the public. Some off-label prescribing may result because manufacturers have chosen not to invest the resources needed to have FDA add indications to the drug's approval and labeling. A worst-case scenario for the nation's health would be the widespread acceptance of a drug for an off-label use that sufficient research would have revealed to be ineffective, unsafe, or both. Aside from the drug's direct harm, the time spent waiting to see whether it worked would have been time not spent exploring other treatment options. Unchecked off-label prescribing may also threaten the FDA gold standard of drug approval. If clinicians had already accepted a new use into practice through off-label prescribing, a manufacturer may choose to not invest resources to go through clinical trials and the FDA process to win approval. Although manufacturers do share information on off-label uses, courts have sometimes found they had overstepped allowable bounds. Congress has given permission for limited sharing. Are there other ways to share clinical information that do not put the public's health or FDA's authority at risk? What Role Can Congress Play in the Use of Off-Label Prescriptions? How might Congress, in its legislative or oversight roles, consider the use of off-label drugs to protect the public's health? Legislators and health analysts have suggested both restrictive and permissive actions regarding off-label use. Ideasâsome of which conflict with othersâinclude disclosure to patients; data collection, availability, and analysis; dissemination of clinical data; linking reimbursement and coverage to evidence of safety and effectiveness; clinical research and research transparency; clinical guidance; congressional oversight through the Government Accountability Office, the Federal Trade Commission, and the Department of Health and Human Services; and consideration of other countries' approaches to off-label use. Some actions would require federal legislation. Other proposals would involve actions by other entities, such as state authorities and professional organizations, which Congress could urge.


When there is concern with deficit or debt levels, Congress will sometimes implement budget enforcement mechanisms to mandate specific budgetary policies or fiscal outcomes. The Budget Control Act of 2011 (BCA; P.L. 112-25 ), which was signed into law on August 2, 2011, includes several such mechanisms. The BCA as amended has three main components that currently affect the annual budget. One component imposes annual statutory discretionary spending limits for defense and nondefense spending. A second component requires annual reductions to the initial discretionary spending limits triggered by the absence of a deficit reduction agreement from a committee formed by the BCA. Third are annual automatic mandatory spending reductions triggered by the same absence of a deficit reduction agreement. Each of those components is described in further detail in this report. The discretionary spending limits (and annual reductions) are currently scheduled to remain in effect through FY2021, while the mandatory spending reductions are scheduled to remain in effect through FY2029. Congress may modify or repeal any aspect of the BCA procedures, but such changes require the enactment of legislation. Several pieces of legislation have changed the spending limits or enforcement procedures included in the BCA with respect to each year from FY2013 through FY2029. These include the American Taxpayer Relief Act of 2012 (ATRA; P.L. 112-240 ), the Bipartisan Budget Act of 2013 (BBA 2013; P.L. 113-67 , also referred to as the Murray-Ryan agreement), the Bipartisan Budget Act of 2015 (BBA 2015; P.L. 114-74 ), the Bipartisan Budget Act of 2018 (BBA 2018; P.L. 115-123 ), and the Bipartisan Budget Act of 2019 (BBA 2019; P.L. 116-37 ). Those laws included changes to the discretionary limits imposed by the BCA that increased deficits in each year from FY2013 to FY2021. Under current law there are no discretionary spending caps in place for FY2022 and beyond. Following enactment of BBA 2019, the discretionary caps in FY2020 are scheduled to be approximately $667 billion for defense activities and $622 billion for nondefense activities, and the FY2021 discretionary caps are scheduled to be $672 billion for defense activities and $627 billion for nondefense activities. This report addresses several frequently asked questions related to the BCA and the annual budget.


Whether many provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) apply to a particular drug product turns in part on the novelty of the "active ingredient" of the drug in question. In particular, the Food and Drug Administration (FDA) must assess the novelty of the active ingredient in a new drug, comparing it to a previously approved drug's active ingredient to determine whether the new drug qualifies for the five-year "new chemical entity" (NCE) exclusivity. FDA generally cannot accept new drug applications that refer to a drug with NCE exclusivity (i.e., rely on its clinical data and FDA's approval of the drug) for five years. Companies that receive approval for drugs with new active ingredients generally enjoy a competitive advantage in the market while the exclusivity is in effectâand after, depending how long it takes for generic versions to receive approval once applications can be submitted. Comparing active ingredients can be technically quite complicated. For instance, compounds in a final drug product may convert to other compounds through chemical reactions inside the body before arriving at the site of the therapeutic effect. In addition, related but distinct drug molecules may be clinically indistinguishable or convert into the same pharmacologically or physiologically active component inside the body. Alternatively, two drug molecules with the same core compound may have different compounds appended to them by either covalent or noncovalent bonds. For example, replacing a hydrogen atom in an acid molecule with "a metal or its equivalent" forms a salt, while replacing the hydrogen atom with "an organic radical" forms an ester. These derivatives may or may not vary from each other in clinically significant ways. This raises the question of which derivative(s), if any, should be considered to be the same active ingredient as the core or base molecule. Generally, a more expansive interpretation of phrase "active ingredient," that is, one that considers more types of derivatives to be the same active ingredient, reduces the number of drugs eligible for NCE regulatory exclusivity by expanding the drug ingredients considered previously approved, which allows for earlier introduction of generic versions of those drugs. Historically, for the exclusivity provisions, FDA has interpreted "active ingredient" to mean "active moiety," as defined by FDA regulations. FDA generally defines active moiety as the core molecule or ion of a drug (i.e., the drug molecule without certain appendages) that is "responsible for the physiological or pharmacological action of a drug substance." FDA's interpretation has generated disputes between FDA and pharmaceutical companies, as FDA's approach tends to exclude some drugs from being afforded five-year NCE exclusivity under the FD&C Act. In 2015, a federal district court rejected FDA's interpretation as inconsistent with the statutory language, though it did not explicitly invalidate FDA's regulations. In the 116th Congress, legislation has been introduced that would generally codify FDA's current approach to evaluating NCE exclusivity and extend that approach to certain other provisions under the FD&C Act. This proposed legislation would moot questions about the validity of FDA's interpretation and clarify when chemical entities are sufficiently similar to be considered identical for purposes of drug approval and exclusivity.


While many young people have access to emotional and financial support systems throughout their early adult years, older youth in foster care and those who are emancipated from care often lack such security. This can be an obstacle for them in developing independent living skills and building supports that might ease their transition to adulthood. Older foster youth who return to their parents or guardians may continue to experience poor family dynamics or lack supports, and studies have shown that recently emancipated foster youth fare poorly relative to their counterparts in the general population on measures such as education and employment. The federal government recognizes that older youth in foster care and those who have been emancipated, or aged out, are vulnerable to negative outcomes and may ultimately return to the care of the state as adults through the public welfare, criminal justice, or other systems. The U.S. Department of Health and Human Services (HHS) administers the primary federal programs that are targeted to these youth. These include the federal foster care program and the John H. Chafee Program for Successful Transition to Adulthood program ("Chafee program"), both of which are authorized under Title IV-E of the Social Security Act. Foster care is a temporary living arrangement intended to ensure a child's safety and well-being until a permanent home can be re-established or newly established. Under the Title IV-E foster care program, a public child welfare agency must work to ensure that each child who enters foster care is safely returned to his/her parents, or, if this is determined not to be possible or appropriate (by a court), to find a new permanent home for the child. Jurisdictions (states, territories, and tribes) may seek reimbursement for youth to remain in care up to age 21. Approximately half of all states extend care to that age. In addition, the foster care program has certain protections for older youth. For example, jurisdictions must annually obtain the credit report of each youth in care who is age 14 and older. They must also assist youth with developing a transition plan that is in place 90 days before aging out. The law requires that a youth's caseworker—and as appropriate, other representative(s) of the youth—assist and support him/her in developing the plan. The law requires that the plan be guided by the youth, and should include specific options on housing, health insurance, education, local opportunities for mentors, and other supports. The Chafee program provides supports and services to youth ages 14 to 21 who are or were in foster care (with some exceptions). Youth in states that extend foster care to age 21 can be served under the program until age 23. The program authorizes funds to be used for providing assistance in obtaining a high school diploma, career exploration, training in daily living skills, training in budgeting and financial management skills, and preventive health activities, among other purposes. States must meet certain requirements, including that not more than 30% of Chafee funds are used for room and board expenses. The Chafee Education and Training Voucher (ETV) provides funding for Chafee-eligible youth to attend institutions of higher education. Youth can receive up to $5,000 annually for up to five years (consecutive or nonconsecutive) until they reach age 26. The Chafee law directs HHS to collect outcome and other information for current and former foster youth, and HHS established the National Youth in Transition Database (NYTD) for this purpose. Along with the foster care and Chafee programs, other federal programs are intended to help youth currently and formerly in foster care make the transition to adulthood. Federal law authorizes funding for states and local jurisdictions to provide workforce support and housing to older foster youth and youth emancipating from care. Further, beginning on January 1, 2014, eligible young people who were in foster care at age 18 are covered under a mandatory Medicaid pathway until age 26. Youth in foster care or recently emancipated youth are also specifically eligible for certain educational supports.