# Recent Reports

Reports News from the GAO

- Medicare and Medicaid: Additional Actions Needed to Enhance Program Integrity and Save Billions What GAO FoundThe Department of Health and Human Services (HHS) estimated a combined total of over $100 billion in improper payments in the Medicare and Medicaid programs in fiscal year 2023. This represents 43 percent of the government-wide total of estimated improper payments that agencies reported for that year.Improper Payments Estimates for Fiscal Year 2023Note: Estimates also include payments whose propriety cannot be determined due to lacking or insufficient documentation.The Centers for Medicare &amp; Medicaid Services (CMS), within HHS, has taken several steps in response to GAO recommendations to help reduce improper payments in Medicare and Medicaid. These actions have resulted in billions of dollars in federal savings. For example:Improved fraud prevention in Medicare.   CMS implemented capabilities that automatically stopped payments of certain improper and non-payable claims. These improvements generated an estimated almost $2 billion in savings over a 5-year period.	Improved Medicaid managed care oversight.  CMS worked with states and audit contractors to improve oversight. This included an exponential increase in investigations of managed care providers, from 16 in 2016 through 2018 to 893 in 2019 through 2021. Preliminary results indicate that the audits are identifying overpayments.In the current fiscal environment, addressing improper payments and providing sufficient oversight of program spending, more generally, is particularly important. Federal spending for Medicare and Medicaid has grown by almost 80 percent over the past decade and growth in these and other health programs is projected to continue.Health Care and Other Government Program Spending, Actual and ProjectedCMS and congressional action on GAO recommendations related to Medicare and Medicaid has resulted in over $200 billion in financial benefits since 2006. Action on recommendations that remain unimplemented would further enhance program integrity and save billions of dollars in Medicare and Medicaid spending.Provider screening and enrollment.  GAO recommended CMS expand its review of states' implementation of provider screening and enrollment requirements in Medicaid, and monitor progress when states are not fully compliant. For Medicare, GAO recommended that CMS implement a risk-based plan for revalidating enrollment for Medicare providers after pauses during the COVID-19 pandemic.	Prepayment claim reviews in Medicare.  GAO recommended that CMS seek legislative authority to allow Recovery Auditors to conduct prepayment claim reviews, which are generally more cost effective than postpayment reviews in preventing improper payments.	Equalizing certain Medicare payments.  GAO recommended that Congress take action to address that Medicare pays more for certain services based on where they are provided. Congress has taken some actions. For example, this committee proposed and the House passed legislation to equalize payments for certain drug administration services. Taking additional steps to equalize payments has been estimated to save Medicare $141 billion over 10 years.	Telehealth.  In response to the COVID-19 pandemic, HHS temporarily waived certain Medicare restrictions on telehealth and use increased dramatically. We recommended CMS comprehensively assess the quality of telehealth services in Medicare, which is needed to ensure those services are medically necessary, among other things.	Medicaid demonstrations.  In response to GAO recommendations, CMS has made changes to its policies for ensuring that demonstrations do not increase federal spending, reducing federal liabilities by over $120 billion. Additional action by CMS and Congress could result in further savings.	State auditors.  State auditors play an important role in Medicaid oversight and have identified improper payments and other deficiencies through their reviews. GAO recommended that CMS use trends in state auditor findings to inform its Medicaid oversight and share information on the status of actions to address findings with state auditors.Why GAO Did This StudyIn 2023, the Medicare program spent an estimated $1.0 trillion to provide health care services for approximately 66 million elderly and disabled individuals. This involved processing over a billion transactions. Medicaid is a joint federal-state program that finances health care for low-income and medically needy individuals. It is the second largest health care program by expenditures, with an estimated $849 billion in federal and state spending for services provided to about 90 million individuals in 2023.Medicare and Medicaid are complex and large programs. They represented 26 percent of federal program spending in fiscal year 2023. The programs are susceptible to improper payments, as well as potential mismanagement and fraud, waste, and abuse. As a result, GAO added Medicare to its High-Risk list in 1990 and Medicaid in 2003.This testimony focuses on examples of steps taken by CMS to reduce improper payments in Medicare and Medicaid, as well as actions still needed by CMS and Congress. It draws on GAO's reports issued and recommendations made from 2008 through 2024 on the Medicare and Medicaid programs and known steps CMS has taken to address these recommendations as of March 2024.
- Prescription Drugs: Selected States' Regulation of Pharmacy Benefit Managers What GAO FoundPrivate health plans contract with pharmacy benefit managers (PBM) to administer their prescription drug benefits and help control costs. Each of the five states selected for review—Arkansas, California, Louisiana, Maine, and New York—enacted a variety of laws to regulate PBMs.Fiduciary or other “duty of care” requirements.  Four of the five states (California, Louisiana, Maine, and New York) enacted laws to impose a duty of care on PBMs. The laws varied from imposing a fiduciary duty—that is, a requirement to act in the best interest of the health plan or other entity to which the duty is owed—to what state regulators described as “lesser” standards such as a requirement to act in “good faith and fair dealing.”	Drug pricing and pharmacy reimbursement requirements.  The five states enacted a variety of laws relating to drug pricing and pharmacy payments, such as laws limiting PBMs' use of manufacturer rebates and their ability to pay pharmacies less than they charge health plans—a practice referred to as “spread pricing.”	Transparency, including licensure and reporting requirements.  To increase the transparency of PBM operations, the five states enacted laws that require PBMs to be licensed by or registered with the state, or both, and to report certain information such as drug pricing, fees charged, and the amounts of rebates received and retained.	Pharmacy network and access requirements.  The five states also enacted laws regarding pharmacy networks and patient access. Examples include laws prohibiting discrimination against unaffiliated pharmacies and limiting patient co-pays charged by PBMs.The regulators GAO interviewed from selected states described lessons learned regarding PBM regulation. Examples include the following.Regulators in four states said that providing regulators with broad regulatory authority was more effective than enacting specific statutory provisions. Doing so allowed regulators to address emerging issues without new legislation, according to regulators from one state.	Some regulators also stressed the need for robust enforcement of PBM laws and effective penalties to enforce them. Two pharmacy associations GAO interviewed concurred with these views, while a health plan association said that monitoring is needed to ensure compliance with PBM requirements. Three regulators also said that clear reporting requirements and definitions helped ensure consistent enforcement.The Department of Labor provided technical comments on a draft copy of this report, which GAO incorporated as appropriate.Why GAO Did This StudyPrescription drug spending by private health plans climbed to nearly $152 billion in 2021, an 18 percent increase from 2016. Health plans generally rely on PBMs to process claims, develop pharmacy networks, and negotiate rebates from drug manufacturers. However, some researchers and stakeholders have questioned certain PBM practices, such as PBMs retaining a share of the rebates and use of spread pricing. In response, states have begun to enact legislation addressing PBMs, with all 50 states having enacted at least one PBM-related law between 2017 and 2023.GAO was asked to review states' regulation of PBMs serving private health plans. Among other things, this report describes actions selected states have taken to regulate PBMs, and lessons learned that state regulators identified for PBM regulation.GAO focused on a selection of five states that have enacted a wide range of PBM laws, based on existing inventories maintained by national policy research organizations, such as the National Conference of State Legislatures. GAO reviewed states' laws and interviewed state regulators as well as a variety of other stakeholders. These included state pharmacy associations and state health plan associations in each of the five states, and four national organizations representing interests of PBMs, patients, employers, and drug manufacturers, respectively.For more information, contact John E. Dicken at (202) 512-7114 or dickenj@gao.gov.
- Military Health Care: DOD Should Improve Its Process for Clinical Adverse Actions against Providers What GAO FoundThe Defense Health Agency (DHA) uses its clinical adverse action process to investigate concerns about a health care provider's quality of care, and if warranted, to take action to limit or prohibit the care a provider is allowed to deliver. GAO reviewed 55 clinical adverse action cases at four selected military medical treatment facilities and found that they did not always adhere to certain requirements. For example, in more than one-third of the cases, the facilities did not adhere to the DHA requirement to establish a deadline for the investigation of a provider. GAO found that, while DHA monitors facilities' adherence by conducting an audit of each case and by monitoring the process, DHA's monitoring approach does not include information needed to assess adherence to many of the facility-level steps of the clinical adverse action process.GAO also found that DHA did not always report providers within required time frames to the National Practitioner Data Bank. This database is an electronic repository administered by the federal government that is used by hospitals and others across the health care industry to obtain information on providers with histories of substandard care or misconduct. GAO found that while DHA reported all 14 of the providers from the four facilities in GAO's review who received a final clinical adverse action, DHA did not meet the 30-day reporting requirement for four providers.Defense Health Agency Adherence to Requirements for Reporting 14 Final Clinical Adverse Actions to the National Practitioner Data BankDHA's approach to monitoring its clinical adverse action process does not include information needed to assess adherence to certain requirements, such as whether DHA reports providers within required time frames. Further, DHA has not established timeliness requirements for many of the DHA-level steps in the process, such as legal reviews and appeal panel meetings. GAO found it took DHA almost one year on average to complete its steps for 14 cases that resulted in final clinical adverse actions. While DHA's procedures state that the purpose of the clinical adverse action process is to ensure timely resolution of issues and reporting, GAO found that DHA does not sufficiently monitor its timeliness. Such deficiencies could present risks to the quality and safety of care that military service members and their families receive in DOD facilities.Why GAO Did This StudyLike all health care delivery settings, concerns may arise about the quality and safety of care delivered by individual health care providers in the Department of Defense's (DOD) military medical treatment facilities. DHA and its medical facilities share responsibility for investigating concerns and determining whether to take clinical adverse action against providers. DHA is also responsible for reporting any actions taken against providers to regulatory bodies for use among the health care industry.Senate Report 117-39 accompanying the National Defense Authorization Act for Fiscal Year 2022 includes a provision for GAO to review DOD's clinical adverse action process. GAO's review examines adherence to DHA clinical adverse action requirements at four selected facilities and at the DHA-level. GAO reviewed documentation of 55 clinical adverse action cases initiated between October 2019 and September 2022 by four facilities, selected to obtain variation in location and the number of clinical adverse actions conducted. Additionally, GAO reviewed DHA procedures and interviewed DHA officials and facility staff.
- Coast Guard Health Care: Information on Telehealth Usage What GAO FoundThe Coast Guard began offering video and telephone telehealth appointments to its personnel in 2021 in response to the COVID-19 pandemic, according to officials. The Coast Guard piloted an updated video telehealth platform in 2022 across behavioral health clinics, with full deployment to primary care settings occurring in September 2023. The service continues to formalize its telehealth program; for example, the Coast Guard formalized its telehealth policy in December 2023, and Coast Guard officials told GAO they are working on establishing standardized scheduling practices for telehealth appointments and improving their monitoring capabilities.According to Coast Guard officials and documents, the benefits of telehealth include increasing access to medical care for personnel located in remote locations and maximizing staff resources at Coast Guard clinics. Challenges the Coast Guard identified include issues with the Coast Guard's IT infrastructure that may, for example, limit the use of telehealth while at sea due to inconsistent internet connectivity aboard Coast Guard vessels.GAO found that the Coast Guard has plans to address these challenges. For example, the service is in the process of improving its internet capabilities aboard its vessels and is developing standardized scheduling practices for telehealth appointments in Coast Guard clinics.Why GAO Did This StudyThe James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 includes a provision for GAO to report on aspects of the Coast Guard's telehealth program. This report describes how the Coast Guard uses telehealth to provide medical care to its active duty personnel, as well as describes telehealth benefits and challenges identified by Coast Guard officials and documents.To conduct this work, GAO reviewed Coast Guard telehealth policy and guidance documentation, interviewed officials, and conducted site visits to three Coast Guard clinics and three afloat sickbays. Additionally, GAO obtained and reviewed data on the Coast Guard's use of video telehealth from the Defense Health Agency, which manages the video platform. GAO analyzed data from October 2022, the earliest data available at the time of the request, through December 2023, the most recent available at the time of GAO's work.For more information, contact Alyssa M. Hundrup at (202) 512-7114 or hundrupa@gao.gov.
- Health Centers: Revenue, Grant Funding, and Methods for Meeting Certain Access-To-Care Requirements What GAO FoundIn 2022, nearly 1,400 health centers provided primary and preventive health services to more than 30 million people, regardless of their ability to pay. Health centers' total revenue rose from about $28.7 billion in 2018 to $42.9 billion in 2022—an increase of more than $14 billion. The largest single source of revenue was Medicaid, accounting for over one-third of total revenue each year. The second largest revenue source each year was grants, including those provided by the Health Resources and Services Administration (HRSA).Health Center Revenue Sources and Amounts, 2018 and 2022Note: For more details, see figure 2 in GAO-24-106815.HRSA awarded about $34 billion in grant funding to health centers through its Health Center Program in fiscal years 2018 through 2022. About two-thirds of that funding—$23.5 billion—was awarded for service area funding, which supports ongoing operations and services, including existing and recently expanded services, at health centers. The second largest category of funding was provided for the purpose of assisting health centers with preventing, mitigating, and responding to COVID-19. The remaining grant funding supported special initiatives, such as cancer screening; increasing services at existing health centers; and increasing the number of health centers and sites.Health centers used various methods to meet requirements that they provide care at accessible locations and hours, and coverage for medical emergencies after regularly scheduled hours. According to officials from five primary care associations—organizations that provide technical assistance to health centers —most health centers in their states have at least one site that regularly offers extended hours, such as evenings or weekends, to accommodate patient needs. Officials said health centers have varied arrangements to ensure patients are evaluated after hours by a clinician and referred to emergency care or local urgent care as appropriate. GAO's analysis of HRSA's site visit findings from 2018 through 2022 found that over 93 percent of the 1,391 health centers that had a site visit complied with both of these access-to-care requirements. Health centers not in compliance took corrective actions, such as expanding clinic hours to include weekend hours and contracting with nurse triage services to clinically evaluate patients who called with symptoms after regular hours.Why GAO Did This StudyHealth centers rely on revenue from a variety of public and private sources, including grants awarded by HRSA through its Health Center Program. Among other things, HRSA requires health centers to have locations and hours that are responsive to patient needs, and to have procedures to handle medical emergencies that arise after hours.GAO was asked to review health centers' revenue, grant funding, and efforts to meet certain access-to-care requirements. This report describes (1) amounts and sources of health centers' revenue from 2018 through 2022; (2) purposes of HRSA grants awarded from fiscal year 2018 through 2022; and (3) methods used to meet requirements for accessible locations and hours, and coverage of medical emergencies after hours.GAO analyzed health center revenue data from HRSA and the Department of Health and Human Services for 2018 through 2022, the most recent data available. GAO also reviewed documentation for HRSA grants awarded from fiscal years 2018 through 2022 to determine grant amounts and purposes.Additionally, GAO reviewed results of health center site visits HRSA conducted from 2018 through 2022 that assessed compliance with certain access-to-care requirements. GAO also interviewed officials from five primary care associations, selected to achieve variation in geographic distribution and number of health centers in their states.For more information, contact Michelle B. Rosenberg at (202) 512-7114 or rosenbergm@gao.gov.
- Indian Health Service: Opportunities Exist to Improve Clinician Screening Adherence and Oversight What GAO FoundTo provide patients with the highest level of care at its federally operated facilities, the Indian Health Service (IHS) reviews and verifies professional qualifications of clinicians through a process known as credentialing and privileging. GAO found that existing IHS oversight methods did not ensure adherence to all of IHS's credentialing and privileging requirements. GAO's review of a random nongeneralizable sample of 91 clinician files found that IHS generally met some of the requirements reviewed. However, IHS did not meet six of the requirements in 10 percent or more of the applicable files GAO reviewed. (Some of these requirements only apply to clinicians new to IHS.)Indian Health Service (IHS) Adherence to Selected Credentialing and Privileging RequirementsThis lack of adherence was due to IHS not having a single, comprehensive source of its credentialing and privileging requirements and limited monitoring by headquarters. Currently, IHS requirements are spread across multiple, sometimes conflicting, documents, making it challenging for officials to know of and meet them. Further, existing IHS oversight is concentrated at the local level and does not routinely include headquarters' reviews of clinicians' files for adherence with IHS requirements. IHS officials said they plan to improve guidance and oversight, but plans are in initial stages and have not yet been implemented. Until it ensures clinicians are appropriately screened, IHS risks hiring or retaining clinicians with performance, health, or other issues, potentially affecting the quality of care provided to patients and putting them at risk.The 24 IHS clinicians from federally operated facilities who GAO interviewed reported performing a range of tasks they considered to be administrative, including entering data in IHS's electronic health record (EHR) system and communicating about patient care. They varied in the time they estimated spending on administrative tasks; 11 clinicians said they spent 20 percent or less of their time, while 13 said they spent from 21 to 50 percent of their time on such tasks. Clinicians who previously worked in non-IHS facilities generally reported spending less time performing administrative tasks at those facilities than at their IHS facilities. They attributed the difference to non-IHS facilities having a superior EHR, fewer training requirements, or more administrative support.Why GAO Did This StudyIHS provides health care services to 2.8 million American Indians and Alaska Natives, including through a system of federally operated facilities. Clinician competence and excessive time spent on administrative tasks are factors that can affect the quality of care that clinicians provide.GAO was asked to review IHS clinician screening and the performance of administrative tasks. This report examines IHS oversight of credentialing and privileging. It also describes administrative tasks performed by IHS clinicians at federally operated facilities.GAO reviewed IHS policies and other documents, including the most recently available credentialing and privileging file for a random nongeneralizable sample of 91 clinicians. GAO also interviewed officials from IHS headquarters and nine geographic areas, as well as a random nongeneralizable sample of 24 clinicians who were working at an IHS federally operated facility.
- Patient-Centered Outcomes Research Institute: Review of the Audit of the FY 2023 Financial Statements What GAO FoundGAO reviewed the independent public accounting firm's (IPA) financial audit of the Patient-Centered Outcomes Research Institute's (PCORI) fiscal year 2023 financial statements. Based on the limited procedures GAO performed in reviewing the IPA's audit, GAO did not identify any significant issues that it believes require attention. Had GAO performed additional procedures, other matters might have come to its attention that it would have reported. The IPA provided an unmodified audit opinion on PCORI's fiscal years 2023 and 2022 financial statements. Specifically, the IPA found that PCORI's financial statements were presented fairly, in all material respects, in accordance with U.S. generally accepted accounting principles. Further, for fiscal year 2023, the IPA did not identify any deficiencies in internal control that it considered to be material weaknesses or any reportable noncompliance with the selected provisions of laws, regulations, contracts, and grant agreements it tested. PCORI concurred with the IPA's conclusions.Why GAO Did This StudyThis report presents the results of GAO's review of PCORI's fiscal year 2023 financial statement audit. PCORI is a federally funded, nonprofit corporation that is neither an agency nor establishment of the U.S. government. PCORI's purpose is to help patients, clinicians, policymakers, and others make informed decisions about their health and health care options.The Patient Protection and Affordable Care Act requires PCORI to obtain an annual financial statement audit from a private entity with expertise in conducting financial audits. The act includes a provision for the Comptroller General of the United States to review the audit and report the results to the Congress annually. GAO's objective was to review the financial audit of PCORI's fiscal year 2023 financial statements. To satisfy this objective, GAO (1) read and considered various documents relating to the IPA's independence, objectivity, and qualifications; (2) analyzed key IPA audit documentation; (3) read PCORI's fiscal years 2023 and 2022 financial statements, the IPA's audit report on the financial statements, and the IPA's report on internal control over financial reporting and compliance; and (4) met with IPA representatives and PCORI management officials.For more information, contact Cheryl E. Clark at (202) 512-9377 or clarkce@gao.gov.
- Veterans Community Care Program: Additional Information on VA Statutory Appointment Timeliness Measurements is Needed What GAO FoundThe Department of Veterans Affairs (VA) met some but not all of the statutory requirements related to the administration of the Veterans Community Care Program. This critical program allows eligible veterans to obtain health care from community providers under certain conditions. Specifically, VA met the statutory requirement to review and report on community care staffing and training at VA facilities, as required by the Johnny Isakson and David P. Roe, M.D. Veterans Health Care and Benefits Improvement Act of 2020 (Isakson-Roe Act).However, VA did not meet the statutorily required measurements on the timeliness of scheduling community care appointments because its approach prevents it from making certain measurements. Specifically, VA's approach cannot yield data on a certain time point—the date a provider accepts a referral for care—which is needed to calculate two required measurements. According to VA, staff are not required to collect referral acceptance dates. VA told GAO it monitors the scheduling process through other standard reports. While VA disclosed the limitation in its January 2022 report to Congress on the required measurements, it did not indicate how it planned to resolve it to comply with the statute, or if it sought legislative relief in light of changes in its scheduling process since the act was enacted. VA is continuing to internally update these timeliness measurements biweekly, as required by the statute. By engaging with Congress on the limitations it faces, VA could determine any refinements needed to address Congress's oversight needs, or seek legislative relief, as appropriate.VA developed 15 metrics that measure periods of time within its community care scheduling process. It uses these to inform the broader timeliness measurements discussed above. However, GAO found four of the 15 metrics to be unreliable, as these metrics also require data on provider referral acceptance dates (described above) in order to be calculated. For example, GAO found that of the 20,463 referrals for community care completed at nine selected VA facilities from Aug. 16-31, 2023 (the most recent data available at the time of GAO's analysis), only 3 percent (673 referrals) were included in VA's calculations of the four metrics due to the incomplete data on referral acceptance dates. Since VA is continuing to internally update its timeliness data, ensuring that VA discloses to any users of the data the quantity of referrals used to generate the timeliness data would help ensure users understand what the data represent.Why GAO Did This StudyGAO and others have previously identified challenges VA has had in scheduling community care appointments in a timely manner. The Isakson-Roe Act included requirements for VA related to administering community care and to measuring appointment scheduling timeliness, from the date the veteran requires care to the date the community care appointment occurs. It also includes a provision for GAO to review VA's compliance with section 3103 of the act.This report examines (1) VA's compliance with statutory requirements to review and report on community care staffing and training, (2) VA's compliance with statutory requirements to measure community care appointment scheduling timeliness, and (3) the reliability of the metrics VA used to inform the statutorily required timeliness measurements.GAO reviewed community care program reports VA submitted to Congress on staffing, training, and appointment scheduling timeliness. GAO also analyzed the reliability of timeliness data (metrics) for nine VA medical facilities selected for geographic diversity.
- Maternal and Infant Health: HHS Should Strengthen Processes for Measuring Program Performance What GAO FoundThe U.S. has the highest rates of maternal and infant death of developed, high-income countries. The Healthy Start program, administered by the Department of Health and Human Services (HHS), has three goals: reduce rates of infant death, improve maternal health outcomes, and reduce racial and ethnic disparities.HHS funded 101 Healthy Start grantees—e.g., health departments and not-for-profit organizations—in the 2019-2024 grant period. In 2022, grantees served nearly 85,000 participants, including pregnant women, partners, and children. Slightly more than half of participants were Black or African American. Grantees are expected to provide one-on-one consultation and health and parenting education classes, as well as connect participants with medical services.Percentage of Healthy Start Participants by Race in 2022Note: “Other” includes Asian, Native Hawaiian or other Pacific Islander, and multiple races.HHS uses performance data to assess progress toward the first two of Healthy Start's three goals. It has plans to begin stratifying these data by race and ethnicity in 2024 to assess progress toward the third goal: reducing racial and ethnic disparities. HHS is also conducting an evaluation, to be completed in 2025, to assess program progress toward all three goals.Healthy Start data to measure program performance—known as performance measures—align with most GAO-identified key attributes of effective measures. However, the measures do not align with two attributes related to clarity and reliability. For example, HHS's updates to the measures during the 2019-2024 grant period made it challenging for grantees to collect consistent and therefore reliable data. This occurred because HHS lacks a documented process to review its performance measures before implementation. Such a process would help ensure HHS is using measures that are clear and allow for the collection of reliable data.Also, HHS officials said they try to align performance measures across Healthy Start and two related programs. However, HHS lacks a documented process to coordinate the selection of measures used across the programs, and officials could not provide examples of coordination. Implementing a documented process could help ensure that HHS is using the most appropriate measures. Ultimately, this could help HHS gather the best evidence across the programs as they pursue the shared goal of improving health outcomes for mothers and infants.Why GAO Did This StudyThe Healthy Start program awards funding to organizations in areas with high rates of infant death and other adverse maternal and infant health outcomes. In fiscal year 2022, the Healthy Start program received $131 million in appropriations.The CARES Act included a provision for GAO to review and assess Healthy Start. This report: describes Healthy Start grantees and participants served, examines HHS's efforts to assess progress towards Healthy Start goals, examines the extent to which Healthy Start performance measures meet key attributes of effective measures, and examines HHS' efforts to align Healthy Start performance measures with those of related HHS programs.GAO analyzed Healthy Start and other HHS program documentation and data for the most recent grant period (April 2019–March 2024) and the upcoming period (beginning April 2024), including performance measure information. GAO also interviewed HHS officials and six Healthy Start grantees, selected to vary by factors such as geography and years as a grantee.
- Veterans Health Care: Improvements Needed in Patient Tracking for Non-Biological Implantable Medical Devices What GAO FoundMultiple Veterans Health Administration (VHA) offices are involved in overseeing implantable medical devices received by veterans. VHA's National Center for Patient Safety, the lead office for patient safety issues, is responsible for monitoring device safety issues. This office evaluates patient risk when safety issues are identified and collaborates with VHA's clinical program offices to develop VHA's response. National program offices for clinical specialties such as the National Cardiac Device Surveillance Program and the National Surgery Office are also responsible for overseeing cardiac electronic and orthopedic devices, respectively.GAO found that VHA is unable to ensure that all non-biological implantable medical devices are tracked to individual patients. Such tracking is important so that when a safety issue occurs VHA can ensure patients are notified and receive appropriate care. For the two clinical specialties reviewed, the National Cardiac Surveillance Program was able to effectively track cardiac electronic devices to individual patients, but the National Surgery Office was not able to effectively do so for orthopedic devices. VHA policy requires tracking outside the medical record for cardiac devices but does not require it for orthopedic devices. Accordingly, this gap adversely affects VHA's ability to ensure such tracking is occurring.Example of Knee and Hip Replacement Implantable Medical DevicesGAO also found VHA has not fully assessed, across all specialties, its ability to ensure that non-biological implantable medical devices can be effectively tracked to individual patients. Officials with the National Center for Patient Safety and others have recognized the need to develop better tracking capabilities across VHA. An assessment of VHA's ability to track all non-biological implantable medical devices across all clinical specialties could help the agency target and prioritize the most critical devices. This would help ensure these patients receive appropriate care in the event of safety issues.Why GAO Did This StudyVHA provided health care to over 6 million veterans in fiscal year 2022. Such care can include receiving an implantable medical device. The approximately 226,000 implants provided each year by VHA include biological implants made from body tissues, such as skin grafts, or non-biological implants made from materials such as plastic or metal. Examples of the latter include pacemakers and hip replacements.The James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 includes a provision for GAO to study VHA's oversight of implantable medical devices. This report (1) describes VHA offices that oversee implantable medical devices; (2) describes VHA's monitoring of implant safety issues; and (3) examines how VHA ensures tracking of non-biological implants to individual patients.GAO reviewed policies, data, safety reports, and other information on non-biological implants with a focus on certain cardiology and orthopedic implants. GAO interviewed officials from VHA and four VA medical centers (and their regional management), selected based on factors such as the volume of cardiology and orthopedic implants, facility size, and location.
- Science & Tech Spotlight: At-Home Tools to Diagnose Alzheimer's, Parkinson's, and Related Diseases Why This MattersNeurodegenerative diseases such as Alzheimer’s and Parkinson’s can make day-to-day tasks challenging because they may affect cognitive, motor, and social function. Neurodegenerative diseases affect about 7 million people in the U.S. Researchers expect cases to increase as the population ages. Earlier detection of these diseases may help health care providers treat patients before the onset of severe symptoms and slow disease progression.Key TakeawaysAt-home tools may facilitate earlier detection of neurodegenerative diseases.	These tools can be a cost-effective way to collect information that is difficult to gather in a clinical setting.	Health care providers can use information from at-home tools to help diagnose neurodegenerative disease, but such tools are not a replacement for clinical care.The TechnologyWhat is it?&nbsp;At-home tools collect and analyze patient data on certain indicators that relate to cognitive ability—memory, reasoning, and language—and motor function. This includes walking, writing, stability, and the presence of tremors. Tools such as digital cognitive assessments and wearable sensors have the potential to help health care providers detect and diagnose neurodegenerative diseases earlier and more accurately. The tools help assess patients in an environment more reflective of daily life, detect indicators that are challenging to observe in a clinical setting, and collect data on patients’ health over time. Traditional diagnostic approaches—which occur in a clinical setting such as a physician’s office—can be more invasive, less convenient, and may not identify these symptoms until the disease is more advanced.Figure 1: Patient and health care provider use of at-home toolsHow does it work?&nbsp;Digital cognitive assessments use web- or application-based technologies to gather data on a patient’s cognitive abilities. For example, one activity asks patients to memorize objects and their position in a pictured room.Wearable sensors worn on or near the body measure a range of indicators. Sensors on the hands, wrists, or ankles can collect data on the speed and direction of movements—such as hand tremors, sway, or postural adjustments—that may be indicative of neurodegenerative disease. Smartphones equipped with movement sensors can collect similar data when worn near the body. Researchers found that smartphone sensors can identify whether a person exhibits symptoms associated with Parkinson’s disease based on the way they move.How mature is it?&nbsp;Multiple manufacturers of digital cognitive assessments—which could be administered at-home—have registered with the Food and Drug Administration. However, such at-home assessments are not widely commercially available, and more research is needed on their accuracy.Wearable sensors vary in their maturity and use. Specifically, sensors worn on the body are an established tool to assess mobility. Researchers call for further studies to investigate the accuracy of smartphone-based sensors prior to applying them more broadly in diagnosis.OpportunitiesProvide data to support early diagnosis.&nbsp;Providers can use data from at-home tools to inform earlier or more appropriate interventions to slow cognitive decline and improve symptom management. As technologies mature, patients could also potentially use insights from at-home tools to decide whether they need to consult a provider.	Reduce time and cost.&nbsp;At-home tools can be a practical and cost-effective way to reduce the number of clinic visits in the early stages of a disease when symptoms are still ambiguous. Because the tools can be used remotely, patients can reduce travel time and cost, especially if they live far from a clinic or have limited mobility.	Provide easier access to diagnosis.&nbsp;At-home tools could help improve access to diagnostic information if they are self-administered, which can be particularly helpful in instances where a patient has health care access issues.ChallengesLimited testing.&nbsp;Some tools were designed for use at the clinic and researchers have conducted limited testing for at-home use. For example, quality control testing of at-home digital cognitive assessments lags behind those delivered in a clinical setting, but testing is critical to understand a tool’s reliability.	Digital divide.&nbsp;At-home tools may be less useful and less widely adopted if patients do not understand how they work or do not have devices to access them. This challenge could contribute to disparities in diagnosis.	Data privacy and security.&nbsp;Data could be sold, shared without consent, or accessed via data breaches, although data covered by the Health Insurance Portability and Accountability Act of 1996 are provided some additional safeguards.Policy Context and QuestionsWhat are the possible policy implications for existing federal programs such as Medicare, Medicaid, and Social Security Insurance?	What strategies, if any, might help enhance the benefits and use of at-home tools?	What oversight or resources could help ensure the tools do not exacerbate health disparities and the digital divide?	What safeguards could protect data privacy and security?Selected GAO WorkScience &amp; Tech Spotlight: Wearables,&nbsp;GAO-24-107303Technology Assessment: Artificial Intelligence in Health Care,&nbsp;GAO-22-104629Selected ReferencesOhman et al., “Current Advances in Digital Cognitive Assessment for Preclinical Alzheimer’s Disease,”Alzheimer’s and Dementia Diagnosis,Assessment and Disease Monitoring,&nbsp;(2021) doi: 10.1002/dad2.12217.Adams et al., “Digital Technology in Movement Disorders: Updates, Applications, and Challenges,”Current Neurology and Neuroscience Reports,vol. 21, no. 4(2021).For more information, contact Karen L. Howard, PhD at (202) 512-6888 or howardk@gao.gov.
- Clinical Research: FDA Should Evaluate Its Efforts to Recruit and Retain Its Inspection Workforce What GAO FoundThe Food and Drug Administration (FDA) conducts inspections to, among other things, help ensure the quality and integrity of clinical research used to support drugs seeking marketing approval in the U.S. FDA's clinical research inspections peaked in fiscal year 2017 but have since declined. FDA officials attributed this decrease to the COVID-19 pandemic and not having enough investigators.Number of FDA Clinical Research Inspections Related to Drugs, Fiscal Year 2014 through March 1, 2023From fiscal years 2012 through 2020, FDA classified 3 percent of clinical research inspections as having serious deficiencies that would warrant regulatory actions. Investigators GAO spoke with were frustrated that problems they identified (e.g., failure to follow research protocols) did not result in more serious classifications. FDA is limited in its ability to cite serious deficiencies for a common type of study supporting generic drugs. Specifically, the regulations for these studies do not include certain requirements for basic study conduct, such as record retention and following study protocols. FDA has started the process of revising these regulations. Having effective requirements will be important to help ensure high-quality research.FDA has faced challenges recruiting and retaining investigators, resulting in fewer inspections and a less experienced workforce. For example, FDA was unable to complete about 30 percent of one type of common inspection within the requested time frames from fiscal year 2018 through July 2023, according to agency information. FDA officials and the investigators GAO spoke with identified low compensation and high amounts of travel as contributing to these challenges. FDA has taken steps to increase recruitment and retain investigators, such as increased compensation and student loan repayment. The agency recently made progress recruiting new investigators, but attrition has been a persistent problem and it can take new investigators up to a year to independently conduct inspections. Although FDA made progress, the agency has not formally evaluated its efforts to determine their effectiveness. Such an evaluation could help FDA determine whether it is using the most appropriate tools to maintain its workforce. GAO has cited workforce as a concern across multiple FDA programs and sustained attention in this area will be critical.Why GAO Did This StudyClinical research—clinical trials and other studies involving human subjects—for drugs seeking FDA approval can occur in the U.S. or overseas. During inspections, FDA goes on-site, such as to hospitals or other health care settings, to examine research protocols and records as well as the entity and facility involved in the research. Challenges in other FDA inspection programs contributed to GAO placing FDA medical product oversight on its High-Risk List in 2009.GAO was asked to review FDA's inspections of clinical research. This report, among other objectives, describes inspections FDA conducted from fiscal years 2012 through 2023; describes the frequency with which FDA identified serious deficiencies during inspections; and examines FDA's efforts to maintain its investigator workforce. For this work, GAO examined FDA data and documents and interviewed FDA officials. GAO also interviewed 15 out of about 100 investigators, selected to represent diversity among the different investigator positions and tenure with FDA.
- SUPPLEMENTAL MATERIAL FOR GAO-24-106446: Strengthening Coordination and Monitoring of Autism Activities in the Federal Government This supplement is a companion to GAO's report entitled Autism Research and Support Services: Federal Interagency Coordination and Monitoring Efforts Could Be Further Strengthened, GAO-24-106446. The purpose of this supplement is to provide an "Easy Read" version of the report. Easy Read is a way some groups make their written information easier to understand. For example, Easy Read documents use short sentences and plain language.In its report, GAO found that the National Institutes of Health (NIH) works with 18 federal agencies that have activities to help people with autism. NIH has followed several key actions to coordinate these activities, through the Interagency Autism Coordinating Committee and the National Autism Coordinator. But more action could be taken. For example, NIH could find other ways to track progress on the Committee's autism goals and to identify problems reaching goals. This would help make sure agencies and other entities with autism activities understand the types of steps being taken on Committee goals. This would also help show where there may be gaps. Also, NIH could write down the steps that its Office of National Autism Coordination uses to check for possible duplication among autism activities.GAO made two recommendations in its report: The Department of Health and Human Services should (1) develop a process to clearly track and report progress toward the Committee's goals; and (2) ensure that NIH writes down the steps its Office of National Autism Coordination uses to make sure federal autism activities are not unnecessarily duplicative. The Department of Health and Human Services concurred with the recommendations.For more information, contact John E. Dicken at (202) 512-7114 or dickenj@gao.gov.
- Medicaid Managed Care: Additional Federal Action Needed to Fully Leverage New Appeals and Grievances Data What GAO FoundManaged care plans have some flexibility in determining when to authorize services for enrollees. Managed care enrollees may appeal denials of requested services and file grievances about any dissatisfaction not covered by an appeal. Data on appeals and grievances are an important tool for oversight of managed care, as they can help reveal quality and access issues. The first year of data from state annual managed care reports indicated that rates of appeals and grievances per 1,000 enrollees varied widely across states in 2022. Among other things, this could signal problems with access to needed services.Medicaid Managed Care Plan Appeal Rates Across States with Reliable Appeals Data, Contract Year 2022The Centers for Medicare &amp; Medicaid Services (CMS) has begun taking steps to address limitations in the new appeals and grievances data. For example, as of December 2023, CMS had conducted technical assistance with seven states to address data gaps and inconsistencies. CMS has also outlined its intentions to use these data for oversight and to enhance transparency. However, GAO found:No data on outcomes or number of denials.  CMS does not require states to report on the outcomes of enrollee appeals (e.g., whether a plan overturns its initial denial upon review) or the number of denials. These data elements are key to identifying potential problems with enrollee access to services.	Delayed progress on planned actions to use the data.  As of December 2023, CMS had made limited progress on its plans to analyze the data and make data available to the public. Taking these steps would help to inform CMS's data quality efforts and provide incentives for states to focus on quality.By requiring states to report additional data and implementing planned steps to use the data, CMS would be better positioned to meet its goal to use the data to target program improvement, including around enrollee access to care.Why GAO Did This StudyOver 70 percent of Medicaid enrollees receive services through managed care. Because there can be financial incentives for managed care plans to deny or limit services, appeal and grievance systems serve as a safeguard to protect enrollees. States are required to use appeals and grievances data to monitor managed care plans' performance. Beginning in 2022, states were also required to report certain managed care plan appeals and grievance data and other information to CMS annually.GAO was asked to examine the new appeals and grievances data. This report (1) describes what the first-year data indicate about appeals and grievances, and (2) examines CMS's efforts to address any limitations in the data and its efforts to use the data for oversight.GAO analyzed appeals and grievances data for state contract year 2022 across 35 states, and interviewed officials from five of these states, selected on the basis of geography and other factors. GAO also reviewed CMS documents, interviewed CMS officials, and assessed CMS's efforts against agency guidance.
- VA Health Care: Organization of the Office of Mental Health and Suicide Prevention What GAO FoundThe Department of Veterans Affairs (VA) bases its approach for suicide prevention on its 2018 National Strategy for Preventing Veteran Suicide. This strategy outlines a comprehensive public health approach to suicide prevention that includes a combination of (1) clinically-based interventions, such as suicide risk screening for individual patients, and (2) community-based programs and services, such as programs to promote firearm safety to the public to reduce the risk of suicide by firearms.In 2017, the Veterans Health Administration (VHA) organizationally combined the Office of Suicide Prevention and the Veterans Crisis Line——which GAO refers to collectively as suicide prevention programs—with mental health policy and operations in its newly created Office of Mental Health and Suicide Prevention (OMHSP). VHA stated that it created OMHSP to ensure oversight and management of evidence-based strategies within VHA and the community related to identifying veterans with mental health care needs, identifying veterans in crisis, and decreasing the rate of veteran suicide.OMHSP leadership officials identified benefits and challenges related to the placement of suicide prevention programs within OMHSP. For example, OMHSP's leadership officials reported that including suicide prevention and mental health within the same office facilitated internal coordination, which was beneficial when implementing new legislation that targeted suicide prevention and mental health issues. However, Suicide Prevention Branch officials reported challenges related to the office's public health suicide prevention efforts. For example, officials said their placement within OMHSP has given them less autonomy with decision-making, such as decisions about suicide prevention initiatives, which require multiple levels of approval.In July 2023, VHA approved a number of changes to its organizational structure that include moving both the Suicide Prevention Program and Veterans Crisis Line out of OMHSP into a separate program office within VHA's Office for Clinical Services. VHA conducted an assessment to determine the best placement for these programs. VHA's assessment and officials GAO spoke with identified several benefits and challenges related to this organizational change. The benefits included the importance of having the Suicide Prevention Office in a more elevated position within Clinical Services given its priority within the department and its need to coordinate across multiple VHA offices. The challenges included that keeping suicide prevention within the Office for Clinical Services could give the impression that suicide prevention is solely a clinical issue. VHA documents indicate that it plans to implement this change in 2024. As VHA implements these organizational changes, it will be important for it to determine whether this structure achieves the benefits it has anticipated and addresses anticipated, as well as any unanticipated, challenges or risks.Why GAO Did This StudySuicide is a persistent public health problem facing all populations, but particularly veterans. Veterans suffer a disproportionately higher rate of suicide compared to non-veterans. An average of almost 18 veterans died by suicide each day in 2021—a rate about 72 percent higher than the general adult population. VA reported that about 62 percent of the veterans who died by suicide in 2021 had not obtained recent health care through VHA. VHA works to build networks of support, communication, and health care across communities in which veterans live and work to help prevent deaths by suicide of veterans who do not obtain care through VA' health system.Suicide prevention is VA's stated top clinical priority. VHA's suicide prevention programs have the lead responsibility for overseeing and implementing the department's suicide prevention initiatives. Among its responsibilities, the Suicide Prevention Program helps implement VA's National Strategy. VHA's Crisis Hotline is a national toll-free number that supports veterans in emotional crisis. Since establishing these programs in 2007, VHA has moved their organizational placement within various program offices at its national headquarters, also referred to as the central office, multiple times.In May 2017, both suicide prevention programs were placed alongside VHA's mental health programs within the newly established OMHSP. However, in July 2023, VHA approved a number of changes to its organizational structure, including changes to the placement of these suicide prevention programs.GAO conducted its review of VA's management of its mental health and suicide prevention services, including OMHSP's organizational structure, pursuant to law. This report answers key questions related to the organization of OMHSP and its suicide prevention programs.For more information, contact Alyssa M. Hundrup at (202) 512-7114 or hundrupa@gao.gov.
- Biomedical Research: Actions Needed to Adopt Collaboration Practices to Address Research Duplication What GAO FoundThe Department of Health and Human Services (HHS) has long invested in biomedical research. Within HHS, among others, the Advanced Research Projects Agency for Health (ARPA-H), the National Institutes of Health (NIH), the Biomedical Advanced Research and Development Authority (BARDA), and the Food and Drug Administration (FDA) fund or conduct biomedical research. Each of these four HHS agencies' research activities have the potential for duplication when funding research in common areas.GAO found the four selected HHS agencies use multiple practices intended to help avoid unnecessary research duplication. These include reviewing project and funding information provided by applicants, consulting with experts and other agencies, and using databases to identify potentially overlapping research (see figure). When evaluating instances of research duplication, agency staff also distinguish between necessary and unnecessary duplication. GAO previously reported that some research duplication is necessary to confirm results or otherwise advance a project or field, whereas unnecessary duplication is research not needed to replicate or complement prior results.Example of HHS Agencies' Practices to Avoid Unnecessary Research DuplicationIn 2022, Congress directed the ARPA-H Director to, among other things, coordinate with other federal departments and agencies to ensure that ARPA-H's research is free of unnecessary duplication and established the ARPA-H Interagency Advisory Committee of eight federal agencies to coordinate efforts, among other functions. Such coordination can be a means for ARPA-H and committee member agencies to share information on their research activities and help ARPA-H avoid unnecessary duplication. ARPA-H officials told GAO that the committee will serve as a forum to identify and address potential research duplication between ARPA-H and these agencies. However, the Committee's draft charter does not mention how the members would collaborate to help ARPA-H identify and avoid funding research duplication. Leading practices for interagency collaboration include identifying shared goals and having documented agreements regarding the collaboration. By finalizing the charter to include members' agreement on collaboration methods to avoid ARPA-H funding unnecessary duplication, ARPA-H will be better positioned to improve the future return on the nation's investment in transformational health research.Why GAO Did This StudyHHS's mission is to enhance the health and well-being of all Americans by, among other things, fostering sound, sustained advances in the sciences. HHS's longstanding agencies—NIH, BARDA, FDA—as well as its newest agency, ARPA-H, fund biomedical research.The Consolidated Appropriations Act, 2023, includes a provision for GAO to issue a series of reports on potential duplication in HHS's biomedical research and development portfolio. To manage the scope and reporting timeline, this first report focuses on ARPA-H, BARDA, FDA, and NIH as specified in the Act. It (1) describes practices used by the selected HHS agencies to identify and avoid unnecessary research duplication and (2) examines ARPA-H's collaboration and efforts to establish an interagency advisory committee as a potential means to prevent unnecessary research duplication.To conduct this work, GAO reviewed agency information, and legislation, among other documents. GAO also interviewed agency officials and a non-generalizable selection of non-federal experts in biomedical research.
- Autism Research and Support Services: Federal Interagency Coordination and Monitoring Efforts Could Be Further Strengthened What GAO FoundThe National Institutes of Health (NIH), within the Department of Health and Human Services (HHS), plays a key role in supporting the coordination of autism activities across 18 federal agencies, including the Departments of Defense and Education. For example, NIH manages the Interagency Autism Coordination Committee (IACC), a federal advisory committee composed of federal agencies and public members, through its Office of National Autism Coordination.GAO found that NIH, in support of the IACC and the National Autism Coordinator, generally followed six of eight key collaboration practices that GAO's prior work has shown can be effective in enhancing and sustaining interagency collaborative efforts among federal entities. For example, NIH has taken steps to bridge organizational cultures by convening meetings of the IACC.Assessment of the National Institutes of Health's (NIH) Role in Supporting Coordination of Federal Autism Activities Compared with Leading Practices for Interagency CoordinationGAO found NIH efforts to support interagency coordination partially followed the remaining two collaboration practices, including ensuring accountability. For example, although IACC strategic plans describe high-level progress made toward autism activities, they generally have not described how progress made relates to goals. NIH officials stated their progress tracking approach is driven by established processes, some of which are required by law. Establishing a clear process for tracking progress would help to determine progress toward IACC's goals and that interagency efforts are effective.NIH helps ensure federally funded autism activities are not unnecessarily duplicative through various activities, such as holding meetings and through data and information reviews. However, GAO found the processes used by NIH's Office of National Autism Coordination were not documented. For example, NIH does not have written procedures describing the steps these staff should follow when reviewing federal autism research information for potential duplication. Although NIH officials stated that they believe current monitoring processes are sufficient, documenting these procedures will help ensure they are properly designed and executed to provide reasonable assurance that duplication is not occurring.Why GAO Did This StudyThe federal government plays an important role supporting research, programs, and other activities to promote the health and well-being of people with autism. Multiple federal agencies are involved in autism activities. To help coordinate and monitor federal autism activities and to ensure activities are not unnecessarily duplicative, Congress directed the Secretary of Health and Human Services to establish the IACC and designate an official to facilitate coordination and implementation of autism activities, known as the National Autism Coordinator.GAO was asked to examine coordination and monitoring of federal autism activities. This report examines NIH efforts to (1) help coordinate federal autism activities and (2) monitor autism activities to ensure federal autism activities are not unnecessarily duplicative.GAO reviewed NIH documents and relevant federal laws; assessed NIH's role in supporting coordination of autism activities against key practices that GAO identified in prior work; and gathered information from 19 federal agencies that conduct autism activities.
- Maternal Health: HHS Should Improve Assessment of Efforts to Address Worsening Outcomes What GAO FoundMaternal mortality and other adverse outcomes associated with pregnancy or childbirth worsened significantly in 2020 and 2021, as compared with 2018 and 2019, according to Department of Health and Human Services (HHS) data. Disparities in maternal health outcomes persisted during the pandemic for certain groups. For example, the maternal mortality rate among non-Hispanic, Black or African American women was about 2.5 times greater than non-Hispanic, White women during these years, according to GAO's analysis of HHS data.Maternal Mortality by Race and Ethnicity, 2018 – 2022Notes: A maternal death is the death of a woman that occurs during or within 42 days of pregnancy from any cause related to or aggravated by the pregnancy or its management. All racial groups are not Hispanic or Latina; Hispanic or Latina women may be of any race.The  White House Blueprint for Addressing the Maternal Health Crisis  was released in June 2022 in response to worsening outcomes and disparities. It highlights specific federal actions and outlines long-term goals for improving maternal health. HHS offices intend to develop a strategy for assessing the performance of these long-term goals. However, as of September 2023, HHS had not indicated whether the strategy will include key practices, such as establishing near-term goals and performance measures, to track the performance of their efforts  .  Doing so would allow HHS to better assess its efforts to improve maternal health.The blueprint also identifies key maternal health efforts, such as the Centers for Disease Control and Prevention's (CDC) Perinatal Quality Collaborative program, which supports multidisciplinary teams implementing maternal health quality improvement initiatives. The CDC program has both long- and near-term goals, but the near-term goals lack quantitative targets, such as targets specifying the anticipated number of facilities participating in the Perinatal Quality Collaborative program. Establishing such targets would allow CDC to assess the program's progress to help improve maternal health outcomes.Why GAO Did This StudyThe U.S. is experiencing a maternal health crisis: it has one of the highest maternal mortality rates among high-income nations; increasing rates of complications from pregnancy or childbirth; and persistent disparities in such outcomes, according to HHS. GAO previously reported that the COVID-19 pandemic exacerbated maternal health outcomes and highlighted racial disparities.The CARES Act includes a provision for GAO to report on its COVID-19 pandemic oversight efforts. GAO was also asked to review maternal health during the pandemic. Among other things, this report describes what available HHS data show about maternal health during COVID-19, and examines the extent to which HHS agencies have incorporated key practices to assess the performance of selected HHS maternal health efforts. GAO selected efforts based on factors such as the number of states in which teams implement the efforts. GAO reviewed HHS data for various years from 2016 through 2022 (based on availability), reviewed agency documentation, compared efforts against key practices, and interviewed HHS officials and stakeholders.
- VA Health Care: Opportunities Exist to Further Meet Student Veterans' Mental Health Needs What GAO FoundThe Department of Veterans Affairs (VA) provides health care to veterans for mental health conditions, such as depression and substance use disorders. VA data showed that the percentage of student veterans who received mental health care at VA facilities increased from fiscal years 2017 through 2022, and at a higher rate than that of the total veteran population. (See figure.) VA data show student veterans were primarily treated for depression-related disorders, post-traumatic stress disorder, and anxiety-related disorders. VA officials said younger veterans typically seek mental health care more than older veterans, and most student veterans are younger than age 34. Further, the COVID-19 pandemic exacerbated mental health conditions for the general population, including for veterans.Comparison of Student Veterans and All Veterans Receiving Mental Health Care at VA Facilities, Fiscal Years 2017 through 2022Note: The percentages reflect student veterans and all veterans receiving mental health care (i.e., at least one visit for any mental health diagnosis), among student veterans and all veterans who received any health care at VA facilities, respectively. In fiscal year 2022, 261,000 student veterans and 5,966,000 veterans in total received health care at VA facilities.VA administers the Veterans Integration to Academic Leadership program to support the mental health needs of student veterans. Under this voluntary program, VA health care systems—including medical centers and other facilities—can partner with local colleges and universities to provide campus-based mental health support to student veterans. As of October 2023, 32 of 139 health care systems have such programs. However, GAO found VA does not communicate comprehensive information to its health care systems to help them consider when and how to implement programs, such as the types of staffing needed. Instead, VA communicates information about the program upon request. By more regularly communicating comprehensive information across its health care systems, such as through guidance, VA could help ensure its systems all have the information they need to consider participating in the program. This, in turn, would help ensure VA's ability to support the mental health needs of its student veteran population.Why GAO Did This StudyMental health conditions have been a persistent and growing issue for the nation's veterans. Research suggests that student veterans—those pursuing a course of education using VA's educational assistance benefits—are more likely to experience anxiety, stress, depression, and suicidal ideation than their nonveteran peers.The Support the Resiliency of Our Nation's Great Veterans Act of 2022 includes a provision for GAO to study the mental health needs of student veterans. Among other objectives, this report (1) describes what available VA data show on the use of mental health care by student veterans and (2) examines VA efforts to address the mental health needs of student veterans through its Veterans Integration to Academic Leadership program.GAO reviewed VA documentation and data for fiscal years 2017-2022 (the most recent available) on mental health care use and diagnoses and conducted a literature search. GAO also interviewed officials from VA and a non-generalizable selection of three veterans service organizations, as well as 12 student veterans identified by one of the veterans service organizations.
- Veterans Affairs: Improvements Needed in Estimating Funding for Potential Future Health Emergencies What GAO FoundAs of September 30, 2023, the Department of Veterans Affairs (VA) obligated roughly $36.2 billion (98.6 percent) of its CARES Act, Families First Coronavirus Response Act, and American Rescue Plan Act of 2021 funds, with the majority obligated by its Veterans Health Administration (VHA).VA Obligations of COVID-19 Supplemental Funding Totaled $36.2 Billion as of September 30, 2023VA used COVID-19 supplemental funds to support new efforts in response to the pandemic, such as expanding VA's information technology infrastructure to provide telehealth services. It also used the funding to support already established VA programs, such as providing health care at VA medical facilities.When the COVID-19 pandemic emerged, VHA requested supplemental funding to continue operations to meet its mission. However, VA found it was not prepared to estimate the amount of supplemental funding needed during such a catastrophic event, because it did not have the modeling capacity to do so. VHA officials told GAO they have not developed the modeling capacity needed to estimate the costs of future catastrophes, such as a pandemic, because such modeling is outside of the scope of its contract with its actuarial consultant responsible for developing VA's budget projections. By developing modeling capacity for estimating the resources needed to respond to potential future health emergencies, VHA would be better prepared to quickly estimate resource needs to allow better management and planning.Why GAO Did This StudyIn response to the COVID-19 pandemic, VA received approximately $36.70 billion in supplemental funding between 2020 and 2021. CARES Act and Families First Coronavirus Response Act funds were available until September 30, 2021, and September 30, 2022, respectively. American Rescue Plan Act of 2021 funds were generally available until September 30, 2023.The VA Transparency &amp; Trust Act of 2021 includes a provision for GAO to review VA's requests for and use of COVID-19 supplemental funding, including American Rescue Plan Act of 2021 funds. Among other issues, this report describes how VA used these funds and examines how VA estimated its funding needs to inform the fiscal year 2024 budget request for key areas previously supported with COVID-19 supplemental funds.GAO reviewed VA data and spending plans for COVID-19 supplemental funding and VA processes used to develop budget request estimates for fiscal years 2022 through 2024. GAO also interviewed VA officials and VA's actuarial consultant responsible for developing estimates.
- Defense Health Care: DOD Should Monitor Urgent Referrals to Civilian Behavioral Health Providers to Ensure Timely Care What GAO FoundDOD's Defense Health Agency (DHA) oversees the TRICARE program, which offers behavioral health care to active-duty service members. DOD aims to provide this care at its military treatment facilities (MTF), but may also refer service members to civilian network providers. GAO's analysis of DHA data found that in fiscal year 2022, service members obtained routine and urgent specialty behavioral health care appointments (e.g., psychotherapy and substance use disorder treatments) at MTFs within required time frames (see figure). For referrals to civilian network providers, appointments after routine referrals fell just outside time frame requirements. Regarding appointments after urgent referrals, DHA has not established a specific time frame, but MTFs are instructed to use such referrals when expedited care is needed. GAO found average appointment wait times following these referrals ranged from over 2 weeks, to more than 3 weeks, depending on the region.Average Days to Active-Duty Service Members' Initial Specialty Behavioral Health Care Appointments, Fiscal Year 2022Note: MTF urgent behavioral health care appointments should generally occur within 24 hours. For all other initial specialty appointments, including with civilian providers, DHA applies a 28-day standard.Provider vacancies were the main challenge to maintaining behavioral health care appointment availability for service members, according to officials at the six MTFs GAO selected for site visits. This is consistent with DHA-wide data, which showed vacancy rates for MTF civil service behavioral health care providers exceeded 40 percent, as of January 2023. To mitigate the effects of provider vacancies, officials from selected MTFs reported taking several steps, including increasing referrals to civilian network providers and prioritizing initial over follow-up appointments. DHA officials also reported taking mitigation steps, such as piloting a new triaging approach to better match patients' needs to level of care.GAO found that DHA generally monitors the timeliness of behavioral health care provided to its service members under TRICARE. However, because there is not an established time frame for obtaining specialty appointments specific to urgent referrals to civilian network providers, DHA monitors urgent and routine network referrals in the aggregate rather than separately. As a result, DHA does not know the extent to which service members with urgent behavioral health concerns are experiencing delays obtaining the critical care they need following a referral outside an MTF. It also is not able to identify factors that may be contributing to delays and in turn, address any timeliness issues.Why GAO Did This StudyMilitary service may carry a psychological cost for active-duty service members. Recent research has shown a fourfold increase in behavioral health conditions for this population. If left untreated, such conditions can affect deployment readiness, among other negative consequences.A House report includes a provision for GAO to examine efforts to address mental health under the Department of Defense's (DOD) TRICARE program. This report (1) describes DHA data on average days to outpatient specialty behavioral health care appointments for active-duty service members in fiscal year 2022; (2) describes challenges to availability for these appointments at selected MTFs and steps taken to mitigate those challenges; and (3) examines relevant DHA oversight efforts.GAO reviewed DHA documents and interviewed agency officials; analyzed DHA data on behavioral health care appointments in fiscal year 2022 (the most recent available) and staffing levels in fiscal year 2023; and conducted site visits at six MTFs, selected for variation in military service affiliation, installation size, and geographic location.
- Drug Safety: FDA Has Faced Persistent Challenges Overseeing Foreign Drug Manufacturing What GAO FoundOver the years, GAO has reported on efforts by the Food and Drug Administration (FDA) to improve its oversight of foreign drug manufacturing establishments. FDA inspected a relatively small number of foreign establishments in fiscal year 1997 but significantly increased these numbers over the next two decades, with a peak in fiscal year 2016. However, beginning in March 2020, FDA postponed most inspections because of the COVID-19 pandemic.During the time inspections were paused, FDA used alternative inspection tools to maintain oversight of drug manufacturing quality. These tools included relying on inspections conducted by foreign regulators and requesting and reviewing records and other information. The postponement of inspections led to a backlog of establishments never inspected or not inspected by FDA within 5 years—categories for which FDA considers inspections mandatory. GAO reported that this backlog could both extend the interval between inspections and reduce the resources FDA has available for other high-priority inspections.Since 2007, GAO also has reported on unique challenges to conducting foreign inspections that can raise questions about their equivalence to domestic inspections. For example, in January 2022, GAO reported that, while domestic inspections have almost always been unannounced, FDA's practice of generally preannouncing foreign inspections up to 12 weeks in advance may have given establishments the opportunity to fix problems before the inspection. As a result, investigators may be less likely to see the true day-to-day operating environment of foreign establishments as compared to domestic. Further, FDA has relied on translators provided by the foreign establishments being inspected, which investigators noted can raise questions about the accuracy of information FDA investigators collect.Vacancies among investigators available to conduct foreign inspections represent another challenge GAO identified in multiple reports. In January 2022, GAO reported that FDA had persistent vacancies among staff who specialize in foreign inspections. This included vacancies among U.S.-based staff who conduct foreign inspections and among staff in FDA's foreign offices located in China and India.Why GAO Did This StudyFDA is responsible for ensuring the safety and effectiveness of all drugs marketed in the U.S., regardless of where they are produced. Globalization and the COVID-19 pandemic have complicated FDA's oversight of the more than 4,800 establishments manufacturing drugs for the U.S. market. FDA reported that 58 percent of these establishments were located overseas as of October 2022. GAO has had long-standing concerns about FDA's ability to oversee the increasingly global drug supply chain, an issue highlighted in our High-Risk Series since 2009. A critical element in FDA's oversight of overseas manufacturing is its inspection of foreign manufacturing establishments.This statement discusses findings related to FDA's foreign drug inspection program that GAO has reported on over two decades, including findings that GAO previously reported in January 2022 and in its April 2023 High-Risk Series. This statement provides observations on FDA's inspections of foreign drug manufacturers, challenges unique to conducting foreign inspections, and FDA's foreign inspection workforce. For GAO's prior work, it analyzed FDA inspection and workforce data, interviewed FDA staff—including drug investigators who conduct foreign inspections—and reviewed agency documents. This statement also includes updates on the status of agency efforts to address relevant recommendations that GAO previously identified.
- Veterans Health Care: VHA Has Taken Steps towards Improving Vet Centers What GAO FoundThe Veterans Health Administration's (VHA) Readjustment Counseling Service (RCS) provides counseling to individuals, groups, couples, and families through 303 Vet Centers nationwide. In fiscal year 2023, RCS data show that Vet Centers provided about 1.3 million counseling visits to more than 104,000 clients.Example of a Department of Veterans Affairs Vet Center ExteriorIn its May 2022 report, GAO found that VHA lacked processes that would help it better assess Vet Center activities. Specifically,VHA did not collectively assess whether Vet Centers were meeting clients' needs.  GAO found that RCS and Vet Centers used assessments and feedback surveys to assess each individual client's needs. However, RCS had not assessed the extent to which Vet Centers were meeting the needs of client subpopulations, like those with traumatic brain injury, that may experience different readjustment challenges.	VHA lacked data to tailor outreach and assess its effectiveness.  GAO found that Vet Centers used data from outreach activities, such as the number of contacts made, to try to assess their effectiveness. However, there were limitations to using these data because not all outreach activities resulted in contacts, according to officials from RCS and Vet Centers.	VHA did not identify whether its actions were minimizing barriers to Vet Center care.  GAO found that RCS and Vet Center officials identified barriers to Vet Center care, such as lack of awareness of Vet Center services. Officials also identified steps they have taken to address barriers. However, RCS officials did not know the extent to which barriers to Vet Center care remained because RCS did not have an assessment process.Based on these findings, GAO made five recommendations in its May 2022 report. As of January 2024, VHA had implemented one of GAO's recommendations by assessing the extent to which Vet Centers were meeting the needs of their clients collectively. VHA has taken some steps towards implementing the other four recommendations. Continued attention to these recommendations will help ensure veterans and servicemembers are receiving the help they need readjusting to civilian life or to continued military service.Why GAO Did This StudySome veterans and servicemembers experience challenges, such as mental illness, when readjusting to civilian life or continued military service. This can be due to trauma experienced during military service. VHA's Vet Centers provide services to eligible veterans, servicemembers, and their families.This statement describes the findings from GAO's May 2022 report, GAO-22-105039, which examined VHA's efforts to assess Vet Center clients' needs, tailor outreach activities and assess their effectiveness, and identify and address barriers to care. This statement also describes the status of VHA's efforts to implement GAO's recommendations. For this statement, GAO reviewed VHA's reports of steps RCS has taken to address GAO's recommendations.
- Hospital Financing: Volume Limits and Reporting Could Help Manage Risks of Expanding FHA's Mortgage Insurance Program What GAO FoundThe Federal Housing Administration's (FHA) Hospital Mortgage Insurance Program insures loans for capital improvements at hospitals that primarily provide general acute care services. The number and types of loans FHA insured annually varied in fiscal years 2000–2022, partly in response to economic conditions and program expansions. For example, program use temporarily increased in 2009 following creation of the Build America Bonds program (which incentivized infrastructure projects) and in 2013 following a program expansion that codified certain options to refinance non-FHA-insured debt.Number of New Hospital Mortgage Loans Insured Annually by FHA, by Loan Type, Fiscal Years 2000–2022Hospital types generally ineligible for FHA's program, such as psychiatric and long-term care hospitals, have characteristics that can limit their financing options or increase financing costs compared to eligible hospital types. They are generally smaller facilities and have lower average revenues and profit margins than eligible hospital types. Hospitals with smaller revenue bases and weaker financial performance may have difficulty qualifying for affordable loans or securing public credit ratings needed to issue bonds.Extending the program to ineligible hospitals could increase program participation and risks, but specific effects are difficult to estimate. GAO estimates that about 2,600 additional hospitals could become eligible, but the number that could meet FHA's underwriting standards is unknown, and some characteristics of these hospitals could add uncertainty to FHA's underwriting process. For example, less predictable revenue sources at some psychiatric hospitals could challenge FHA's ability to estimate long-term default risks. Prior practices Congress has used to manage FHA program risks may be applicable to expanding the hospital program. These include initially limiting the volume of new loans and requiring FHA to regularly report on program activity, including the performance of new loans. Such practices would help ensure that program risks related to an expansion were effectively monitored, controlled, and evaluated.Why GAO Did This StudyFHA's Hospital Mortgage Insurance Program currently insures more than $6 billion in loans for the expansion and renovation of hospitals that provide general acute care services, such as surgeries and treatments for injuries and short-term illnesses. Legislation introduced but not enacted in the 117th Congress proposed extending eligibility to hospitals that primarily provide non-acute care services, such as treatment of mental health disorders.GAO was asked to evaluate the potential effects of expanding program eligibility. This report examines (1) use of the program from fiscal years 2000–2022, (2) characteristics of ineligible hospital types that may affect their financing options, and (3) the potential effects of extending eligibility on program participation and risks.GAO analyzed FHA documents and data for fiscal years 2000–2022; hospital financial data from the Centers for Medicare &amp; Medicaid Services for 2016–2020 (the most recent available year); and industry, academic, and government reports. GAO also interviewed representatives from FHA, lenders, mental health providers, appraisers, and hospital and health care associations.
- Federal Regulation: Selected Emerging Technologies Highlight the Need for Legislative Analysis and Enhanced Coordination What GAO FoundSelected federal agencies—the Department of Transportation (DOT), the Federal Communications Commission (FCC), and the Food and Drug Administration (FDA)—reported using a variety of practices and approaches to prepare for and address regulatory challenges and opportunities posed by emerging technologies. However, FDA officials said updated authorities would help it regulate medical devices enabled with artificial intelligence (AI), in particular. Members of Congress are currently considering enhancing oversight of AI, including in medical devices, and congressional members have discussed barriers with FDA. However, FDA has not clearly identified, documented, and communicated to Congress the specific legislative changes that would help it address these challenges. Without this information, Congress may not be able to appropriately update FDA's authorities, and FDA may miss opportunities to fully realize the public health benefits of this technology.Examples of Emerging Technologies: 3D Printing of Biological Materials, Next Generation Wireless, and Drones Selected federal agencies have reported coordinating with other domestic and foreign agencies to support their efforts to regulate some emerging technologies. Agencies' interagency collaboration activities include efforts to share information and pursue goals for these technologies. However, DOT has not communicated progress made on a department-wide council to resolve jurisdictional and regulatory gaps associated with emerging transportation technologies. By assessing and publicly communicating the council's plans and progress, DOT could provide important information to stakeholders and help ensure the council is accountable for achieving its goals.Knowledge-building and outreach efforts used by some selected foreign regulators were more extensive than those used by selected domestic regulators, particularly with industry and academia. For example, foreign regulators have clear channels for communicating with industry, the public, and regulated entities. The Federal Aviation Administration (FAA) recently established a group to engage with industry on drone regulation. But FAA could improve its outreach and communication with industry by publicizing this initiative, called the Emerging Technologies Coordination section. FAA currently does not include information online about how to contact this group. Industry can only participate in it by FAA's invitation, which may prevent some entities from getting the full benefit from its assistance.Why GAO Did This StudyEmerging technologies have the potential to unlock immense societal benefits. Developing effective regulations to tackle complex emerging problems takes time. As a result, these technologies present a pacing problem for regulators. Ensuring regulations keep pace with the rapid development of emerging technologies is critical to protecting public interests and facilitating innovation.GAO was asked to review how federal agencies regulate emerging technologies. This report examines, for selected agencies, (1) challenges and opportunities they report facing in regulating emerging technologies; (2) their collaboration and cooperation activities; and (3) lessons they can learn from other governments' experiences.GAO reviewed documentation and interviewed officials from DOT, FCC, FDA, and other knowledgeable agencies and compared agencies' coordination efforts to selected leading practices. GAO also interviewed government officials in the European Union, the United Kingdom, and Japan, as well as 10 stakeholders spanning industry groups, academia, and other experts about practices in regulating emerging technologies.
- Food Safety: FDA Should Finalize Plans to Implement Its Rule to Help Trace Source of Outbreaks What GAO FoundIn November 2022, the Food and Drug Administration (FDA) promulgated a final rule on food traceability to help identify the source of outbreaks of foodborne illness. In developing the rule, the FDA established a list of certain foods for which enhanced recordkeeping is required, and set a compliance date of January 20, 2026. Entities handling an item on the list must maintain specific records, including a traceability plan, at certain points in the item's supply chain.To identify foods for the list, FDA used an approach that incorporates statutorily mandated criteria, such as the history and severity of prior outbreaks involving the item. Several stakeholders GAO interviewed said FDA's methodology for identifying foods for the list was appropriate. Several other stakeholders disagreed with this assessment, stating that FDA's approach resulted in an overly inclusive list. In response to similar comments on the draft rule, FDA provided its rationale for considering foods at the commodity—or category—level, stating that foods in these groups had similar risk characteristics and associated hazards.Examples of Points in the Supply Chain Required to Maintain Traceability Records for a Produce Item on the Food Traceability List FDA has taken some steps to help industry and nonfederal regulators prepare for compliance with and enforcement of the rule. Also, in late 2022, FDA began an iterative planning process for implementing the rule. However, as of October 2023, FDA had not finalized or documented an implementation plan, according to FDA officials.Components of such a plan could help address challenges stakeholders identified in preparing for the compliance deadline. For example, the plan could include additional information on nonfederal regulators' roles in the inspection process and FDA's enforcement strategy and needed resources. It also could identify additional guidance, training, and tools for stakeholders. By finalizing and documenting an implementation plan, FDA will have better assurance it is well positioned to make progress toward its regulatory goals and address the various challenges that stakeholders identified to achieving compliance by the deadline.Why GAO Did This StudyFoodborne illness remains a common and costly public health problem in the U.S. Being able to efficiently trace products linked to a foodborne illness outbreak can help government agencies and those who produce and sell food identify the source of the outbreak. FDA, within the U.S. Department of Health and Human Services (HHS), is responsible for developing and implementing several rules required by the FDA Food Safety Modernization Act, enacted in 2011. These include the food traceability rule.The act also included a provision for GAO to report on the traceability rule. This report, among other things, (1) describes FDA's and selected stakeholders' views on the rule's recordkeeping requirements and (2) examines FDA's actions to implement the rule and challenges FDA and stakeholders may face in achieving compliance.GAO reviewed FDA documentation and interviewed FDA officials and 20 selected stakeholders representing industry associations, consumer advocacy groups, and nonfederal regulators.
- Public Health Preparedness: HHS Emergency Agency Needs to Strengthen Workforce Planning What GAO FoundThe Administration for Strategic Preparedness and Response (ASPR) leads the nation's medical and public health response to emergencies. Its workforce has increased substantially to fulfill this growing role, roughly doubling from 1,000 to almost 2,000 employees from fiscal year 2019 to 2022. Contract staff contributed to most of this growth. Officials stated they used these staff to scale up quickly to respond to the COVID-19 pandemic; use will decrease as the response unwinds.ASPR Workforce by Position Type, from Fiscal Year 2019 to 2022ASPR is developing an in-house hiring office with the aim of improving its hiring capabilities. ASPR officials expect the office to be fully operational by October 2025. The office is to address four areas of concern that ASPR had with services provided by the Department of Health and Human Services (HHS) staff division: hiring costs, time-to-hire, service quality, and unique workforce needs, according to ASPR documentation and interviews. However, ASPR does not have specific goals and performance measures to use for the office, once operational, to help ensure these areas of concern will be addressed. For example, while time-to-hire had been slow in the past, officials could not provide specific goals or measures that outline how the new office will improve upon the status quo, especially given that the HHS staff division has made service improvements, according to ASPR officials. Specific goals and measures provide a framework for monitoring progress and will allow ASPR to make adjustments, if needed. In addition, ASPR intends to hire 41 human capital staff for the office by October 2025. However, it does not have tailored recruitment and hiring strategies that account for government-wide shortages of these staff.ASPR's December 2022 strategic plan prioritized strategic workforce planning, including conducting workforce assessments to identify critical skills and competencies needed to achieve the agency's mission. Further, in February 2023, ASPR announced a new organizational structure to better achieve its mission. However, ASPR has not identified critical areas in the agency that need workforce assessments nor developed a plan to conduct them. It also has not conducted an agency-wide workforce assessment to prioritize the skills and competencies of greatest need to achieve the agency's goals and mission. Without conducting these assessments, ASPR cannot be assured that its workforce has the skills and competencies in place to support its reorganization, and ultimately, to meet its mission of leading the nation's response to public health emergencies.Why GAO Did This StudyASPR is a component within HHS. GAO placed HHS's leadership and coordination of public health emergencies on its high-risk list in January 2022, in part because ASPR did not have strategic workforce planning in certain areas. ASPR has relied on an HHS staff division, and other agencies, to assist with its hiring needs.The CARES Act includes a provision for GAO to report on oversight efforts related to the COVID-19 pandemic. This report examines: (1) the size of ASPR's workforce, (2) ASPR's plans for improving its hiring capabilities, and (3) ASPR's strategic workforce planning practices.To conduct this work, GAO reviewed ASPR documentation and workforce data and interviewed HHS and Office of Personnel Management (OPM) officials. GAO assessed ASPR's actions against GAO's key principles of strategic workforce planning and agency reform and OPM guidance.
- Veterans Health: VA Should Improve Its Monitoring of Severe Maternal Complications and Mental Health Screenings What GAO FoundThe Department of Veterans Affairs (VA) set a goal to understand and reduce veterans' maternal deaths and severe maternal morbidity, which is an unexpected outcome or complication of labor and delivery resulting in significant health consequences. VA data showed that 13 veterans died from pregnancy-related causes out of about 40,000 VA-paid delivery hospitalizations from fiscal years 2011 through 2020, 11 of whom were White. Further, GAO's analysis indicates the severe maternal morbidity rate increased from 93.5 per 10,000 VA-paid delivery hospitalizations in fiscal year 2011 to 184.6 per 10,000 in fiscal year 2020. This rate was highest among Black or African American veterans. VA monitors information on maternal deaths by race and ethnicity, and intends to start monitoring severe maternal morbidity rates. However, VA has not specified whether it will monitor these rates by race and ethnicity, among other veteran characteristics. Doing so would enhance VA's ability to improve this adverse maternal health outcome by identifying needed medical interventions or care coordination improvements for particular populations.Severe Maternal Morbidity Rates by Veterans' Race, Fiscal Years 2011—2020Note: VA data capture the number of veterans who had at least one severe maternal morbidity that was not a blood products transfusion as of labor and delivery, using the Centers for Disease Control and Prevention's definition of such morbidity and the Office of Management and Budget's categories of race. American Indian or Alaska Native, Asian, and Native Hawaiian or other Pacific Islander veterans had fewer than 1,000 VA-paid delivery hospitalizations each from fiscal years 2011 through 2020; thus, rates for these groups may be subject to fluctuations if calculated for different periods.According to research, mental health conditions may increase the risk for severe maternal health complications, as well as the risk of maternal death by suicide. VA requires that each VA medical center designate a maternity care coordinator to serve as a liaison among pregnant and postpartum veterans and their health care providers. These staff are required to screen veterans for depression, suicide risk, and, as of October 2023, anxiety and post-traumatic stress disorder. VA officials have taken initial steps to monitor the occurrence and results of these screenings by hiring knowledgeable staff to help identify relevant data. However, VA officials have yet to determine when they will begin such monitoring or how frequently it will occur. As a result, VA may not have necessary information to ensure screenings are completed, which may be particularly important as the new screenings are implemented. Further, VA may lack information on ways to improve maternity care coordination based on screening results.Why GAO Did This StudyPregnant veterans are more likely than other pregnant women to have physical and mental health conditions that may contribute to adverse maternal health outcomes, according to research. Veterans' hospital deliveries, a service VA pays for by referral to community providers, grew by about 85 percent (from 2,567 to 4,766 deliveries) from fiscal years 2011 through 2020.Congress included a provision in statute for GAO to review veterans' maternal health. This report, among other objectives, examines available VA data on, and VA's monitoring of, maternal health outcomes, as well as mental health screenings for pregnant and postpartum veterans.GAO analyzed VA data on deaths and severe maternal morbidity among pregnant and postpartum veterans from fiscal years 2011 through 2020 (the most recent data available); reviewed VA policy and guidance on maternity care coordination; and interviewed VA officials and VA medical center staff. Staff were from four medical centers GAO selected for variation in the average number of deliveries among veterans, among other factors.
- SUPPLEMENTAL MATERIAL FOR GAO-24-106689: Testing Results for Selected Prenatal Supplements This supplemental material is a companion to GAO's report entitled, Prenatal Supplements: Amounts of Some Key Nutrients Differed from Product Labels, GAO-24-106689. For this report, GAO contracted with an accredited laboratory to test 12 prenatal supplements for the amounts of certain nutrients and heavy metal contaminants. The purpose is to provide the detailed laboratory testing results for the 12 prenatal supplements. The supplemental material includes graphical representations of the measured amount of each tested nutrient relative to the amount of that nutrient stated on the label—called the "percent of the label amount." The graphs show these values for each tested nutrient across all tested samples of the selected prenatal supplements described GAO's full report. This supplemental material also includes a table of laboratory testing results for all samples in which heavy metal contaminants were found. For the unprocessed laboratory testing data underlying the analysis, please see the CSV file available on this supplemental material's homepage.For more information, contact Karen L. Howard at 202-512-6888 or HowardK@gao.gov.
- Prenatal Supplements: Amounts of Some Key Nutrients Differed from Product Labels What GAO FoundGAO contracted with an accredited laboratory to test 12 prenatal supplements for amounts of certain nutrients. GAO found that 11 of the 12 of the prenatal supplement products had at least one tested nutrient (folic acid, iodine, iron, or vitamin A, C, or E) that, on average, contained an amount outside of acceptable deviations from the amount stated on the label. This could lead to a pregnant individual either consuming too much or too little of these nutrients. Of these 11, we found one product with an average amount of folic acid that may cause a health concern based on metrics established by the Institute of Medicine. The other tested products that deviated from the amounts stated on the labels did not contain average amounts of nutrients likely to be a health concern. Of the six nutrients tested, Vitamin E showed the greatest variability between different prenatal supplement products, with a range of 28 percent to 332 percent of the amount stated on the label. Vitamin A was the nutrient most frequently found in amounts outside the acceptable deviations from the label value (nine of the 12 supplements). For a full description of the results, see GAO-24-107042.GAO also had the 12 prenatal supplements tested for certain heavy metal contaminants (arsenic, cadmium, lead, and mercury). GAO found trace amounts of two heavy metals—lead or cadmium—in half of the tested prenatal supplements (six of 12), but not in amounts likely to cause a health concern based on metrics used by the Food and Drug Administration (FDA).Many pregnant Americans take prenatal supplements to promote parental and fetal health as soon as they recognize they are pregnant, according to experts with the American College of Obstetricians and Gynecologists. However, dietary supplements—including prenatal supplements—are not generally required to be registered with FDA or evaluated for safety or effectiveness before reaching the shelves. This is because FDA regulates dietary supplements as a special category of food and not as drugs, limiting pre-market oversight. As a result, FDA has limited information about the dietary supplements on the market—including prenatal supplements—to inform its post-market inspections and oversight. Moreover, there is no federal statutory definition of what a prenatal supplement is and what these products should contain, resulting in a large and highly variable product market.Experts and stakeholders GAO spoke with identified a variety of challenges regarding dietary supplements and their oversight. Some concerns include a lack of standardization and limited market knowledge. Prior GAO work also found that FDA faces challenges related to limited information about the dietary supplement market. FDA and a dietary supplement trade association have publicly backed proposed legislation to increase FDA's oversight of dietary supplements, such as requiring dietary supplement manufacturers to register each product on the market with FDA. The stakeholders we interviewed also supported additional oversight of dietary supplements by FDA.Why GAO Did This StudyGAO was asked to assess the accuracy of over-the-counter prenatal supplement labels for amounts of certain nutrients and determine whether the supplements contain harmful substances, such as heavy metals. This Q&amp;A describes the accuracy of labels for the amounts of tested nutrients and possible heavy metal contaminants in 12 selected best-selling prenatal supplements. It also provides information on FDA's role overseeing prenatal supplements.GAO contracted with an accredited analytical laboratory to conduct blind testing of three different lots of each of the 12 selected supplement products for six nutrients and four heavy metals. GAO selected the nutrients and contaminants for testing based on a review of the literature and information available online from expert organizations. The prenatal supplement products tested are a nongeneralizable sample selected from a list of "best-selling" or "top-rated" prenatal supplements from the websites of major retailers and compared to "best of" lists found online. To gain contextual information for the testing results, GAO interviewed selected stakeholders and experts—including third-party dietary supplement testing organizations and the American College of Obstetricians and Gynecologists, respectively. GAO also interviewed officials from relevant federal agencies—including FDA—and reviewed agency guidance and data, relevant legislation, and prior GAO reports to analyze FDA's oversight role for dietary supplements.