Recommendation: The Undersecretary for Health should consistently collect sexual orientation data in VHA's health record system, which could include adding a field for providers to input veterans' sexual orientation. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Undersecretary for Health should analyze veterans' sexual orientation data in order to assess health care outcomes for lesbian, gay, and bisexual veterans. (Recommendation 2)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Undersecretary for Health should consistently collect veterans' self-identified gender identity data within and across record systems. (Recommendation 3)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Undersecretary for Health should analyze veterans' self-identified gender identity data in order to assess health care outcomes for transgender veterans. (Recommendation 4)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Veterans Affairs should ensure the Executive Director of the Veterans Health Administration's Office of Procurement and Logistics, as part of the Veterans Health Administration's ongoing efforts to establish and maintain supplier agreements for the Medical-Surgical Prime Vendor 2.0 formulary, examines opportunities to reduce the number of items delivered via drop shipment to minimize less-preferred methods to purchase supplies. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Veterans Affairs should ensure the Executive Director of the Veterans Health Administration's Office of Procurement and Logistics, as part of the Veterans Health Administration's ongoing efforts to establish and maintain supplier agreements for the Medical-Surgical Prime Vendor 2.0 formulary, examines opportunities to establish delivery time frame requirements for drop-shipped items. (Recommendation 2)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Veterans Affairs should ensure the Executive Director of the Veterans Health Administration's Office of Procurement and Logistics automates aspects of the manual Medical-Surgical Prime Vendor formulary management process where feasible, such as electronic transmittal of real-time updates to medical centers and prime vendors, to minimize ordering errors and delivery delays. (Recommendation 3)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Veterans Affairs should ensure the Executive Director of the Veterans Health Administration's Office of Procurement and Logistics and the Strategic Acquisition Center develop processes to routinely use transaction-level data to validate prime vendor performance on key program metrics, such as order completion rate, and identify how this information will be used to oversee the prime vendors. (Recommendation 4)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Veterans Affairs should ensure the Executive Director of the Veterans Health Administration's Office of Procurement and Logistics develops a process for calculating accurate historical coverage and utilization data for the Medical-Surgical Prime Vendor program, such as archiving monthly formulary snapshots, to increase visibility into medical center needs and issues over time. (Recommendation 5)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Veterans Affairs should ensure the Executive Director of the Veterans Health Administration's Office of Procurement and Logistics develops a plan for assessing the results of the Defense Logistics Agency Medical-Surgical Prime Vendor pilot, including criteria for assessing pilot success and scalability, as well as performance metric targets, and use these criteria and metrics to inform the department's future decision on whether the program should be deployed to all medical centers. (Recommendation 6)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Veterans Affairs should ensure the Executive Director of the Veterans Health Administration's Office of Procurement and Logistics seeks input from stakeholders within the agency, such as the Office of Small and Disadvantaged Business Utilization and medical center staff, on operation of the Defense Logistics Agency Medical-Surgical Prime Vendor pilot to help inform any needed improvements as the pilot progresses. (Recommendation 7)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Veterans Affairs should ensure the Executive Director of the Veterans Health Administration's Office of Procurement and Logistics works with the Office of Small and Disadvantaged Business Utilization to provide written guidance to VA logistics officials at facilities participating in the Defense Logistics Agency Medical-Surgical Prime Vendor pilot program on how to prioritize veteran-owned small businesses when purchases are made through the pilot program, to achieve VA's goal of providing opportunities for these firms to participate in the pilot program. (Recommendation 8)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Under Secretary for Health should establish steps for communicating to VA's actuarial consultant information on data quality, including any limitations, used in the actuarial modeling that informs VA's community care budget estimates. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Under Secretary for Health should establish further steps for assessing and communicating to stakeholders the degree of overall uncertainty associated with actuarial projections for community care that inform the community care budget estimates. (Recommendation 2)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: Congress should consider requiring VA to establish an overall wait-time performance measure for veterans to receive care under the VCCP that will permit VA to measure and monitor the timeliness of VCCP appointments and compare timeliness to that of VA medical facilities. (Matter for Consideration 1)

Agency: Congress
Status: Open

Comments: When we determine what steps the Congress has taken, we will provide updated information.

Recommendation: The Under Secretary of Health should align its monitoring metrics with the time frames established in the VCCP scheduling process. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Under Secretary of Health should conduct a review of community provider enrollment and use of the HSRM to include identifying and taking steps to remove any challenges to community provider enrollment and use; and, if determined appropriate, establish a requirement for community providers to use the HSRM; and (Recommendation 2)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Under Secretary of Health should direct VAMC leadership to assess their community care staffing and resource needs, and develop a plan to address any identified risks to their ability to schedule appointments in a timely manner, including strategies to adjust staff levels and address recruitment and retention challenges as needed. (Recommendation 3)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Under Secretary for Health should ensure the RCS Chief Officer evaluates Vet Center productivity expectations for counselors, including (1) obtaining systematic feedback from counselors on any potentially negative effects on client care, and (2) determining whether directors and counselors need additional training or guidance on how the expectations are calculated. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Under Secretary for Health should ensure the RCS Chief Officer develops a plan and time frames for periodically reassessing its productivity expectations for counselors, and implementing any needed changes as appropriate. (Recommendation 2)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Under Secretary for Health should ensure the RCS Chief Officer develops and implements a Vet Center staffing model that incorporates key practices in the design of staffing models. (Recommendation 3)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Under Secretary for Health should ensure the RCS Chief Officer establishes a plan and time frames for assessing and updating its staffing model regularly, and for implementing any needed changes as warranted. (Recommendation 4)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should establish and implement formal policies to use quality information (e.g., linking decisions to mission-related goals) in the three centers' planning for their personal property needs, consistent with key characteristics integral to asset management leading practices. (Recommendation 1)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should establish and implement formal policies to use quality information (e.g., tracking condition, and maintenance and repair costs) in the three centers' operations and maintenance of personal property, consistent with key characteristics integral to asset management leading practices. (Recommendation 2)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should establish and implement formal policies to use quality information (e.g., measuring and documenting performance) in the three centers' reviews of personal property performance, consistent with key characteristics integral to asset management leading practices. (Recommendation 3)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of GSA should take steps to ensure that the condition of all White Oak facilities that FDA occupies are assessed, including limited access areas and tenant improvements that are above the standard services and facilities that GSA provides. (Recommendation 4)

Agency: General Services Administration
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Health and Human Services in coordination with the Administrator of the Federal Emergency Management Agency—who head agencies leading the COVID-19 response through the Unified Coordination Group—should immediately document roles and responsibilities for supply chain management functions transitioning to the Department of Health and Human Services, including continued support from other federal partners, to ensure sufficient resources exist to sustain and make the necessary progress in stabilizing the supply chain, and address emergent supply issues for the duration of the COVID-19 pandemic. (Recommendation 1)

Agency: Department of Health and Human Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Health and Human Services in coordination with the Administrator of the Federal Emergency Management Agency—who head agencies leading the COVID-19 response through the Unified Coordination Group—should further develop and communicate to stakeholders plans outlining specific actions the federal government will take to help mitigate remaining medical supply gaps necessary to respond to the remainder of the pandemic, including through the use of Defense Production Act authorities. (Recommendation 2)

Agency: Department of Health and Human Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Health and Human Services—who heads one of the agencies leading the COVID-19 response through the Unified Coordination Group—consistent with their roles and responsibilities, should work with relevant federal, state, territorial, and tribal stakeholders to devise interim solutions, such as systems and guidance and dissemination of best practices, to help states enhance their ability to track the status of supply requests and plan for supply needs for the remainder of the COVID-19 pandemic response. (Recommendation 3)

Agency: Department of Health and Human Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of the Federal Emergency Management Agency—who heads one of the agencies leading the COVID-19 response through the Unified Coordination Group—consistent with their roles and responsibilities, should work with relevant federal, state, territorial, and tribal stakeholders to devise interim solutions, such as systems and guidance and dissemination of best practices, to help states enhance their ability to track the status of supply requests and plan for supply needs for the remainder of the COVID-19 pandemic response. (Recommendation 4)

Agency: Department of Homeland Security: Directorate of Emergency Preparedness and Response: Federal Emergency Management Agency
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Health and Human Services, with support from the Secretary of Defense, should establish a time frame for documenting and sharing a national plan for distributing and administering COVID-19 vaccine, and in developing such a plan ensure that it is consistent with best practices for project planning and scheduling and outlines an approach for how efforts will be coordinated across federal agencies and nonfederal entities. (Recommendation 5)

Agency: Department of Health and Human Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: As the Centers for Disease Control and Prevention (CDC) implements its COVID-19 Response Health Equity Strategy, the Director of the Centers for Disease Control and Prevention should determine whether having the authority to require states and jurisdictions to report race and ethnicity information for COVID-19 cases, hospitalizations, and deaths is necessary for ensuring more complete data, and if so, seek such authority from Congress. (Recommendation 6)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: As CDC implements its COVID-19 Response Health Equity Strategy, the Director of the Centers for Disease Control and Prevention should involve key stakeholders to help ensure the complete and consistent collection of demographic data. (Recommendation 7)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: As CDC implements its COVID-19 Response Health Equity Strategy, the Director of the Centers for Disease Control and Prevention should take steps to help ensure CDC's ability to comprehensively assess the long-term health outcomes of persons with COVID-19, including by race and ethnicity. (Recommendation 8)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of the Treasury, in coordination with the Commissioner of Internal Revenue, should update and refine the estimate of eligible recipients who have yet to file for an economic impact payment to help target outreach and communications efforts. (Recommendation 9)

Agency: Department of the Treasury
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of the Treasury, in coordination with the Commissioner of Internal Revenue, should make estimates of eligible recipients who have yet to file for an economic impact payment, and other relevant information, available to outreach partners to raise awareness about how and when to file for economic impact payments. (Recommendation 10)

Agency: Department of the Treasury
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Director of the Office of Management and Budget, in consultation with the Department of the Treasury, should issue the addendum to the 2020 Compliance Supplement as soon as possible to provide the necessary audit guidance. (Recommendation 11)

Agency: Executive Office of the President: Office of Management and Budget
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Director of the Centers for Disease Control and Prevention should ensure that, as it makes updates to its federal guidance related to reassessing schools' operating status, the guidance is cogent, clear, and internally consistent. (Recommendation 12)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Homeland Security, in coordination with the Secretary of Defense, should (1) revise the criteria in the 2019 National Interest Action code memorandum of agreement to clearly identify steps they will take to obtain input from key federal agencies prior to extending or closing a National Interest Action code, (2) establish timelines for evaluating the need to extend a National Interest Action code, and (3) define what constitutes a consistent decrease in contract actions and routine contract activity to ensure the criteria for extending or closing the National Interest Action code reflect government-wide needs for tracking contract actions in longer term emergencies, such as a pandemic. (Recommendation 13)

Agency: Department of Homeland Security
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Defense, in coordination with the Secretary of Homeland Security, should (1) revise the criteria in the 2019 National Interest Action code memorandum of agreement to clearly identify steps they will take to obtain input from key federal agencies prior to extending or closing a National Interest Action code, (2) establish timelines for evaluating the need to extend a National Interest Action code, and (3) define what constitutes a consistent decrease in contract actions and routine contract activity to ensure the criteria for extending or closing the National Interest Action code reflect government-wide needs for tracking contract actions in longer term emergencies, such as a pandemic. (Recommendation 14)

Agency: Department of Defense
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Health and Human Services, in consultation with the Centers for Medicare & Medicaid Services and CDC, should develop a strategy to capture more complete data on confirmed COVID-19 cases and deaths in nursing homes retroactively back to January 1, 2020, and to clarify the extent to which nursing homes have reported data before May 8, 2020. To the extent feasible, this strategy to capture more complete data should incorporate information nursing homes previously reported to CDC or to state or local public health offices. (Recommendation 15)

Agency: Department of Health and Human Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: Based on the imminent cybersecurity threats, the Secretary of Health and Human Services should expedite implementation of our prior recommendations regarding cybersecurity weaknesses at its component agencies. (Recommendation 16)

Agency: Department of Health and Human Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Under Secretary for Health should, in collaboration with relevant VBA and NCA officials, improve its process to accurately identify all on-campus veteran deaths by suicide by ensuring that it uses updated information and corroborates information with VA facility officials. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Under Secretary for Health should expand the policy requirement for a root cause analysis to include all cases of on-campus veteran death by suicide, regardless of whether the veterans involved were enrolled in VHA health care services at the time of their death. (Recommendation 2)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Under Secretary for Health should direct the Office of Mental Health and Suicide Prevention to expand its analyses of on-campus veteran deaths by suicide to include all relevant information VA collects for these incidents, such as data from root causes analyses and information collected through the Behavioral Health Autopsy Program. (Recommendation 3)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of CMS should develop formal procedures that include specific steps to be taken in the APD review process, including how CMS will document the review (including the name of the reviewer, date of review, and what was reviewed); what documentation should be retained after the review; as well as decision-making criteria for approval or denial decisions for state Medicaid IT funding requests. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of CMS should, as part of the APD review process and prior to approval, verify that all of the required information (e.g. alternatives analysis, feasibility study, and cost benefit analysis) is included in the funding request. (Recommendation 2)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of CMS should ensure that all APD-related artifacts are retained within the designated CMS document management system, including documentation of key information from meetings and email communications with the states, the MITA self-assessment and independent verification and validation reports, when creating APD decision packages. (Recommendation 3)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of CMS should require analysts to maintain relevant MMIS and E&E system artifacts based on the entire system life cycle instead of individual APDs. (Recommendation 4)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of CMS should, in consultation with the HHS and CMS CIOs, develop a documented, comprehensive, and risk-based process for how CMS will select IT projects for technical assistance and provide recommendations to states to assist them in improving the performance of the systems, with consideration to those that are high-cost and performing poorly. (Recommendation 5)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of CMS should encourage state Medicaid program officials to consider involving state CIOs in overseeing Medicaid IT projects. (Recommendation 6)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of CMS should establish a timeline for implementing the outcome-based certification process for MMIS and E&E systems. (Recommendation 7)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of CMS should establish documented procedures for how the results of the outcome-based certification process will be used for conducting oversight and making funding decisions. The procedures should include specific steps that CMCS will take to oversee individual state MMIS and E&E projects and how it will demonstrate that the steps have been taken. (Recommendation 8)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: Prior to approving funding for MMIS and E&E systems, the Administrator of CMS should identify areas of duplication or common functionality, such as core MMIS modules, in order to facilitate sharing, leveraging, or reusing Medicaid technologies. CMS should share the results of the review with the state or territory requesting federal funding for a duplicative or similar project and take steps to encourage states to share, leverage, or reuse Medicaid technologies, where possible. (Recommendation 9)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should, as part of the agency's efforts to update OLS's strategic plan for overseeing agency-wide laboratory safety, resolve agency-wide disagreements on the roles and responsibilities for the centers and OLS in implementing laboratory safety reforms. (Recommendation 1)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should, as part of the agency's efforts to update OLS's strategic plan for overseeing agency-wide laboratory safety, address issues of duplication, overlap, and fragmentation within the safety program. (Recommendation 2)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should, as part of the agency's efforts to update OLS's strategic plan for overseeing agency-wide laboratory safety, identify how FDA leadership will communicate agency-wide on a sustained basis about the importance of laboratory safety and OLS's role in ensuring successful implementation of laboratory safety reforms. (Recommendation 3)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should provide OLS—as FDA's laboratory oversight body—with the necessary oversight authority and access to laboratories to oversee FDA's laboratory safety program and ensure compliance with the agency's laboratory safety policies. (Recommendation 4)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should take steps to assess and mitigate any risks to independence posed by funding OLS—as FDA's laboratory safety oversight body—through the working capital fund. In conducting its risk assessment, FDA should specifically focus on ensuring the decision-making processes of the working capital fund supports OLS's independence and ability to hire sufficient staff to implement its laboratory safety oversight priorities. (Recommendation 5)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Under Secretary for Health should fully define in VHA policy the oversight roles and responsibilities related to ensuring facilities' adherence to disbursement agreement policies, including roles related to ReDPro and the role of VISNs. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Under Secretary for Health should more clearly define in VHA policy the purposes of the periodic independent audits and the ReDPro checklist reviews—including differentiating their purposes from one another and ensuring that they do not unnecessarily overlap. (Recommendation 2)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Under Secretary for Health should ensure that OAA and CBI modify the ReDPro checklist and associated guidance, to include ensuring that checklist items are clearly stated, relevant to the updated purpose of the ReDPro checklist, and not unnecessarily duplicative of items to be addressed by the periodic independent audits. The guidance should also include detailed instruction on what the compliance officers should review, and how they should determine the appropriate response for each checklist item. (Recommendation 3)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Under Secretary for Health should ensure that OAA and CBI develop and provide additional ReDPro training for compliance officers, consistent with the updated checklist and guidance. This training should include general information on GME programs and disbursement agreement oversight, as well as detailed information about how ReDPro reviews should be conducted. (Recommendation 4)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Under Secretary for Health should ensure that OAA implements a standardized independent audit tool that is consistent with the updated purpose of the periodic independent audits, and does not unnecessarily overlap with the ReDPro checklist. This could include modifying its existing recommended checklist, or developing a new tool. (Recommendation 5)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Under Secretary for Health should ensure that OAA develops guidance for periodic independent audits to assist the audit teams and facility management in understanding how audits are to be conducted. (Recommendation 6)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Under Secretary for Health should ensure that OAA develops substantive training for independent audit team members, consistent with the updated audit purpose, guidance, and tools. This training should include general information on GME programs and disbursement agreement oversight, as well as detailed information about how the independent audits should be conducted. (Recommendation 7)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of CBP should develop and implement additional guidance for ensuring funds appropriated for specific purposes are obligated consistent with the purpose of the funds. (Recommendation 1)

Agency: Department of Homeland Security: United States Customs and Border Protection
Status: Open

Comments: DHS concurred with this recommendation and said it would take steps to implement it. In July 2020, CBP's Office of Finance issued new guidance on how to execute the remaining funds CBP received in the 2019 Emergency Supplemental. In September 2020, the CBP Budget Directorate's Program Analysis Division also updated its standard operating procedures to describe how it will review samples of purchase requests for supplemental funds. To fully implement our recommendation, CBP should develop and implement guidance for ensuring all funds appropriated for specific purposes, including future appropriations CBP may receive, are obligated consistent with the purpose of the funds.

Recommendation: The Commissioner of CBP should establish and document oversight roles and responsibilities to ensure funds appropriated for specific purposes are obligated consistent with the purpose of the funds. (Recommendation 2)

Agency: Department of Homeland Security: United States Customs and Border Protection
Status: Open

Comments: DHS concurred with this recommendation and said it would take steps to implement it. In September 2020, the CBP Budget Directorate's Program Analysis Division updated its standard operating procedures to describe how it will review samples of purchase requests for supplemental funds. To fully implement our recommendation, CBP should establish and document oversight roles and responsibilities to ensure all funds appropriated for specific purposes, including regular appropriations, are obligated consistent with the purpose of the funds.

Recommendation: The Commissioner of CBP should develop and implement oversight mechanisms for CBP's implementation of policies and procedures relating to medical care for individuals in its custody to include documentation of expected practices, metrics and corresponding performance targets, and roles and responsibilities for taking corrective action. (Recommendation 3)

Agency: Department of Homeland Security: United States Customs and Border Protection
Status: Open

Comments: DHS concurred with this recommendation and said it would take steps to implement it. We will continue to monitor DHS' efforts to address this recommendation.

Recommendation: The Commissioner of CBP should document what information it is using to assess whether to offer the influenza vaccine to individuals in custody, including how it weighs costs and benefits. (Recommendation 4)

Agency: Department of Homeland Security: United States Customs and Border Protection
Status: Open

Comments: DHS concurred with this recommendation and said it would take steps to implement it. We will continue to monitor DHS' efforts to address this recommendation.

Recommendation: The Commissioner of CBP should develop and implement training on recognizing medical distress in children for all CBP officers and Border Patrol agents who may come into contact with children in custody. (Recommendation 5)

Agency: Department of Homeland Security: United States Customs and Border Protection
Status: Open

Comments: DHS concurred with this recommendation and said it would take steps to implement it. We will continue to monitor DHS' efforts to address this recommendation.

Recommendation: The Commissioner of CBP should provide additional guidance to field personnel to ensure they classify significant incident reports on deaths, serious injuries, and suicide attempts, in accordance with CBP policy. (Recommendation 7)

Agency: Department of Homeland Security: United States Customs and Border Protection
Status: Open

Comments: DHS concurred with this recommendation and said it would take steps to implement it. We will continue to monitor DHS' efforts to address this recommendation.

Recommendation: The Commissioner of CBP should update the Significant Incident Reporting System to include categories that align with CBP's directive on the reporting of significant incidents. (Recommendation 8)

Agency: Department of Homeland Security: United States Customs and Border Protection
Status: Open

Comments: DHS concurred with this recommendation and said it would take steps to implement it. We will continue to monitor DHS' efforts to address this recommendation.

Recommendation: The Commissioner of CBP should provide additional guidance to components on the procedures for reporting deaths in custody to OPR and other entities within CBP. (Recommendation 9)

Agency: Department of Homeland Security: United States Customs and Border Protection
Status: Open

Comments: DHS concurred with this recommendation and said it would take steps to implement it. We will continue to monitor DHS' efforts to address this recommendation.

Recommendation: The Commissioner of CBP should ensure that timely, reliable information on deaths in custody is reported to Congress, as directed, and maintain documentation on those reports. (Recommendation 10)

Agency: Department of Homeland Security: United States Customs and Border Protection
Status: Open

Comments: DHS concurred with this recommendation and said it would take steps to implement it. We will continue to monitor DHS' efforts to address this recommendation.

Recommendation: The Secretary of Labor should, in consultation with the Small Business Administration and the Department of the Treasury, immediately provide information to state unemployment agencies that specifically addresses the Small Business Administration's Paycheck Protection Program loans, and the risk of improper payments associated with these loans. (Recommendation 1)

Agency: Department of Labor
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of Internal Revenue should consider cost-effective options for notifying ineligible recipients on how to return payments. (Recommendation 2)

Agency: Department of the Treasury: Internal Revenue Service
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of the Small Business Administration should develop and implement plans to identify and respond to risks in the Paycheck Protection Program to ensure program integrity, achieve program effectiveness, and address potential fraud, including in loans of $2 million or less. (Recommendation 3)

Agency: Small Business Administration
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: In the absence of efforts to develop a plan, we urge Congress to take legislative action to require the Secretary of Transportation to work with relevant agencies and stakeholders, such as the Departments of Health and Human Services and Homeland Security, and members of the aviation and public health sectors, to develop a national aviationpreparedness plan to ensure safeguards are in place to limit the spread of communicable disease threats from abroad while at the same time minimizing any unnecessary interference with travel and trade. (Matter for Consideration 1)

Agency: Congress
Status: Open

Comments: When we determine what steps the Congress has taken, we will provide updated information.

Recommendation: To provide agencies access to Social Security Administration's more complete set of death data, we urge Congress to provide the Department of the Treasury with access to the Social Security Administration's full set of death records, and to require that the Department of the Treasury consistently use it. (Matter for Consideration 2)

Agency: Congress
Status: Open

Comments: When we determine what steps the Congress has taken, we will provide updated information.

Recommendation: To help ensure that federal funding is targeted and timely, we urge Congress to use GAO's Federal Medical Assistance Percentage formula for any future changes to the Federal Medical Assistance Percentage during the current or any future economic downturn. (Matter for Consideration 3)

Agency: Congress
Status: Open

Comments: When we determine what steps the Congress has taken, we will provide updated information.

Recommendation: ASPR should develop an NDMS responder workforce target that aligns with the goals and objectives in ASPR's forthcoming strategic plan. (Recommendation 1)

Agency: Department of Health and Human Services: Office of the Assistant Secretary for Preparedness and Response
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: ASPR should develop an NDMS responder workforce target that accounts for the critical skills and competencies that are needed to meet current and future programmatic results, such as a workforce target that considers (1) a nationwide event or multiple concurrent events, (2) the needs of at-risk individuals, and (3) the availability of other medical responders. (Recommendation 2)

Agency: Department of Health and Human Services: Office of the Assistant Secretary for Preparedness and Response
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: ASPR should develop strategies to fill gaps to achieve its revised workforce target. (Recommendation 3)

Agency: Department of Health and Human Services: Office of the Assistant Secretary for Preparedness and Response
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: ASPR should develop a process to evaluate the web-based and in-person training provided to NDMS responders using GAO-identified key practices for evaluating training. (Recommendation 4)

Agency: Department of Health and Human Services: Office of the Assistant Secretary for Preparedness and Response
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: ASPR should develop a process or approach to prioritize various in-person training needs for its NDMS responders while taking into account budget constraints. (Recommendation 5)

Agency: Department of Health and Human Services: Office of the Assistant Secretary for Preparedness and Response
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of HHS should develop and implement a plan to improve data collected on the prevalence of brain injuries resulting from intimate partner violence and use these data to inform HHS's allocation of resources to address the issue. (Recommendation 1)

Agency: Department of Health and Human Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: For implementation of the EHR system at future VA medical facilities, we recommend that the Secretary of VA direct the EHRM Executive Director to clarify terminology and include adequate detail in descriptions of local workshop sessions to facilitate the participation of all relevant stakeholders including medical facility clinicians and staff. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Defense should ensure that the Assistant Secretary of Defense for Health Affairs, in coordination with the Surgeons General of the military departments and the Director of the DHA, consistently collect complete and accurate information about the quality of available civilian health care in proximity to its MTFs (such as ratings from the Centers for Medicare and Medicaid Services and perceptions from MTF officials who regularly coordinate with civilian providers, among other means) and assess that information to inform recommendations for future MTF restructuring decisions. (Recommendation 1)

Agency: Department of Defense
Status: Open

Comments: DOD partially concurred with this recommendation. In its response, the department described its planned implementation steps, such as publishing measures it may use for assessing available civilian health care. We will continue to monitor the status of the measures and any other actions the department takes to address the recommendation.

Recommendation: The Secretary of Defense should ensure that the Assistant Secretary of Defense for Health Affairs, in coordination with the Surgeons General of the military departments and the Director of the DHA, consistently collect complete and accurate information about the extent to which current health care providers within the TRICARE networks meet access-to-care standards, and assess that information to inform recommendations on future MTF restructuring decisions. (Recommendation 2)

Agency: Department of Defense
Status: Open

Comments: DOD partially concurred with this recommendation. The department noted actions underway and planned to implement it, including a centralized appointment booking system and monitoring access to care as MTFs restructure. We will continue to monitor the status of this effort and any other actions the department takes to address the recommendation.

Recommendation: The Secretary of Defense should ensure that the Assistant Secretary of Defense for Health Affairs, in coordination with the Surgeons General of the military departments and the Director of the DHA, consistently collect complete and accurate information about the extent to which non-network civilian health care providers that could be incorporated into the TRICARE network meet access-to-care standards in terms of drive time, and assess that information to inform recommendations on future MTF restructuring decisions. (Recommendation 3)

Agency: Department of Defense
Status: Open

Comments: DOD partially concurred with this recommendation, and described planned steps to implement it for future MTF restructuring decisions. We will continue to monitor actions the department takes to address the recommendation.

Recommendation: The Secretary of Defense should ensure that the Assistant Secretary of Defense for Health Affairs, in coordination with the Surgeons General of the military departments and the Director of the DHA, conducts a sensitivity analysis of the relative cost-effectiveness of MTF-provided care compared to civilian-provided care under varying assumptions, and document that information for decision makers to inform recommendations on future MTF restructuring decisions. Varying conditions could include different types of health care services, reducing the cost of military personnel salaries, and increasing estimated MTF wRVUs and civilian reimbursement rates. (Recommendation 4)

Agency: Department of Defense
Status: Open

Comments: DOD partially concurred with this recommendation. We will continue to monitor actions the department takes to address the recommendation.

Recommendation: The Secretary of Defense should ensure that the Assistant Secretary of Defense for Health Affairs, in coordination with the Surgeons General of the military departments and the Director of the DHA, establishes clear roles and responsibilities for executing and monitoring transitions for MTFs identified for restructuring. (Recommendation 5)

Agency: Department of Defense
Status: Open

Comments: DOD concurred with this recommendation and described actions underway and planned to implement it. We will continue to monitor actions the department takes to address the recommendation.

Recommendation: The Secretary of Defense should ensure that the Assistant Secretary of Defense for Health Affairs, in coordination with the Surgeons General of the military departments and the Director of the DHA, defines measurable objectives for MTF restructuring transitions, establishes thresholds and goals for each objective, and applies them to evaluate progress and challenges. For example, measurable objectives, thresholds, and goals, should include an evaluation of medical providers' clinical readiness, civilian health care provider adequacy, and the cost-effectiveness of MTF and purchased care. (Recommendation 6)

Agency: Department of Defense
Status: Open

Comments: DOD concurred with this recommendation and described actions underway and planned to implement it. We will continue to monitor actions the department takes to address the recommendation.

Recommendation: The Administrator of CMS should ensure that the Medicare & You publication includes explicit information on the services covered by the Medicare program for beneficiaries with a SUD. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Assistant Secretary for Employment and Training should clarify DOL's expectations of the role of state workforce agencies in addressing the employment and training needs of those affected by SUD and how non-targeted WIOA funding can be used to assist job seekers and employers. (Recommendation 1)

Agency: Department of Labor
Status: Open

Comments: DOL agreed with this recommendation. ETA anticipates providing information and technical assistance to help workforce system grantees understand how they can address the impacts of SUD on the workforce. The agency also plans to issue guidance by the end of 2020 to share promising practices and describe how WIOA funds can be used to support job seekers in recovery and employers.

Recommendation: The Assistant Secretary for Employment and Training should share information from targeted grantees with all state workforce agencies, tribal governments, and outlying areas regarding lessons learned and promising practices in addressing the needs of job seekers affected by SUD and potential employers. (Recommendation 2)

Agency: Department of Labor
Status: Open

Comments: DOL agreed with this recommendation, noting that ETA has created resources that are available to all states based on its experience administering some of the targeted grants. ETA officials cited the recently published literature review and companion resource guide, and said they also plan to share the evaluation of the Phase 1 grants widely when it is available, including any resources or tools developed by states that were awarded Phase 1 grants. In addition, ETA plans to host at least one webinar to share additional promising practices from the targeted grants that could be useful to local workforce boards around the country.

Recommendation: The Secretary of Health and Human Services should develop a mechanism to routinely monitor, evaluate, and report on coordination efforts for infectious disease modeling across multiple agencies. (Recommendation 1)

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services concurred with this recommendation and stated that it is developing a process whereby it will coordinate its efforts in infectious disease modeling across its components, including efforts to monitor, evaluate and report on its coordination. When we confirm what actions the agency has taken in response to the recommendation, we will provide updated information.

Recommendation: The Secretary of Health and Human Services should direct CDC to establish guidelines that ensure full reproducibility of CDC's research by sharing with the public all permissible and appropriate information needed to reproduce research results, including, but not limited to, model code. (Recommendation 2)

Agency: Department of Health and Human Services
Status: Open

Comments: The Centers for Disease Control and Prevention concurred with this recommendation. When we confirm what actions the agency has taken in response to the recommendation, we will provide updated information.

Recommendation: The Director of CDC should take steps to determine participation rates and distribution needed in the AR Option of the National Healthcare Safety Network for conducting regional and national assessments of antibiotic resistance of public health importance. (Recommendation 1)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
Status: Open

Comments: The Department of Health and Human Services concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Director of CDC should ensure that CDC's evaluation of its surveillance system for antibiotic-resistant gonorrhea includes measures of its representativeness, such as comparison of the trends in the sample population with those in the overall U.S. population, using specially designed studies if needed. (Recommendation 2)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
Status: Open

Comments: The Department of Health and Human Services and the Centers for Disease Control and Prevention concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Director of CDC should provide information on uncertainties for antibiotic resistance estimates in its consolidated Threats Reports, including standard errors or confidence intervals, as appropriate. (Recommendation 3)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
Status: Open

Comments: The Department of Health and Human Services generally concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Director of CDC should develop a plan for timely, consolidated reports of antibiotic resistance in priority pathogens at regular intervals. (Recommendation 4)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
Status: Open

Comments: The Department of Health and Human services concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Secretary of HHS should identify leadership and clarify roles and responsibilities among HHS agencies to assess the clinical outcomes of diagnostic testing for identifying antibiotic-resistant bacteria. (Recommendation 5)

Agency: Department of Health and Human Services: Office of the Secretary
Status: Open

Comments: The Department of Health and Human Services concurred with GAO's recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should direct the Center for Devices and Radiological Health to conduct additional monitoring and evaluation of the status of FDA-authorized tests that rely on breakpoints, on a regular basis, to determine whether test manufacturers are updating breakpoints, seeking additional resources as needed. (Recommendation 6)

Agency: Department of Health and Human Services: Public Health Service: Food and Drug Administration: Office of the Commissioner
Status: Open

Comments: The Department of Health and Human Services and the Food and Drug Administration concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Secretary of HHS should develop a strategic framework to further incentivize the development of new treatments for antibiotic-resistant infections, including through the use of postmarket financial incentives, and, if appropriate, make recommendations to Congress for necessary authority. (Recommendation 7)

Agency: Department of Health and Human Services: Office of the Secretary
Status: Open

Comments: The Department of Health and Human Services did not concur with GAO's recommendation. In commenting on our report, the department noted that it has convened a workgroup to develop a strategic framework that includes proposals to address a variety of challenges facing antibiotic product developers and agreed that additional incentives are needed. However, the department stated it is still analyzing whether postmarket financial incentives should be included in this framework. We believe our recommendation is still warranted, given the importance of antibiotic resistance to public health and the importance of sustaining the antibiotic pipeline, including after antibiotics are brought to market. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Secretary of HHS should direct the CARB Task Force to include in its annual updates to the President plans for addressing any barriers preventing full implementation of the National Action Plan and, as appropriate, make recommendations for new or modified actions. Specifically, the CARB Task Force should identify plans to address barriers, such as those related to expanding (1) a CDC program designed to strengthen the U.S. response to resistant gonorrhea; (2) antibiotic stewardship programs across health care settings; and (3) antibiotic use data collection across health care settings, to the extent feasible. (Recommendation 8)

Agency: Department of Health and Human Services: Office of the Secretary
Status: Open

Comments: The Department of Health and Human Services concurred with this recommendation, and stated that beginning in 2020 and continuing annually thereafter, the CARB Task Force's progress reports will include discussion of any barriers preventing full implementation of the National Action Plan, including, as appropriate, barriers that GAO has identified. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Administrator of CMS should take steps to obtain quality information on the experiences of dual-eligible beneficiaries who have been default enrolled into D-SNPs, such as by obtaining information about the extent to which and reasons that beneficiaries disenroll from a D-SNP after being default enrolled. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Director of the Office of Workers' Compensation Programs should develop and implement procedures for coal mine operator self-insurance renewal that clarifies how long an operator is authorized to self-insure; when an operator must submit its renewal application and supporting documentation; and the conditions under which an operator's self-insurance authority would not be renewed. (Recommendation 1)

Agency: Department of Labor: Office of Workers' Compensation Programs
Status: Open

Comments: DOL agreed with this recommendation and said it is acting to implement it to achieve further improvements in ensuring the effective oversight of coal mine operator insurance. DOL reported that it would ensure letters granting or renewing self-insurance authority will inform operators that their authorization expires in one year and that they must submit renewal information three months in advance of the expiration date.

Recommendation: The Director of the Office of Workers' Compensation Programs should develop and implement procedures for self-insured coal mine operator appeals that identify time lines for self-insured operators to submit documentation supporting their appeals and that identify a goal for how much time DOL should take to make appeals decisions. (Recommendation 2)

Agency: Department of Labor: Office of Workers' Compensation Programs
Status: Open

Comments: DOL agreed with this recommendation and said it is acting to implement it to achieve further improvements in ensuring the effective oversight of coal mine operator insurance. DOL reported that it will ensure letters denying self-insurance will inform operators that they have a 30-day appeal period (limited to one extension) and that DOL has set a goal of resolving all appeals within 90 days of the denial letter.

Recommendation: The Director of the Office of Workers' Compensation Programs should develop and implement a process to monitor operator compliance with commercial insurance requirements and periodically evaluate the effectiveness of this process. This process should be designed to detect errors and omissions in reporting insurance coverage using complete, accurate, and consistently recorded data. (Recommendation 3)

Agency: Department of Labor: Office of Workers' Compensation Programs
Status: Open

Comments: DOL agreed with this recommendation and said it is acting to implement it to achieve further improvements in ensuring the effective oversight of coal mine operator insurance. DOL reported that it will modify existing computer systems to identify lapses or cancellations of commercial insurance coverage, and require operators identified as having lapsed or cancelled coverage to obtain or provide proof of coverage within 30 days.

Recommendation: The Secretary of VA should direct GEC leadership to develop measurable goals for its efforts to address key long-term care challenges: workforce shortages, geographic alignment of care, and difficulty meeting veterans' needs for specialty care. (Recommendation 1)

Agency: Department of Veterans Affairs: Office of the Secretary
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of VA should direct GEC leadership to set time frames for and implement a consistent GEC structure at the VAMC level. (Recommendation 2)

Agency: Department of Veterans Affairs: Office of the Secretary
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of VA should direct GEC leadership to set time frames for and implement a VAMC-wide standardization of the tool for assessing the noninstitutional program needs of veterans. (Recommendation 3)

Agency: Department of Veterans Affairs: Office of the Secretary
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of HHS should direct the Biodefense Coordination Team to establish a plan that includes change management practices—such as strategies for feedback, communication, and education—to reinforce collaborative behaviors and enterprise-wide approaches and to help prevent early implementation challenges from becoming institutionalized. (Recommendation 1)

Agency: Department of Health and Human Services: Office of the Secretary
Status: Open
Priority recommendation

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of HHS should direct the Biodefense Coordination Team to clearly document guidance and methods for analyzing the data collected from the agencies, including ensuring that nonfederal resources and capabilities are accounted for in the analysis. (Recommendation 2)

Agency: Department of Health and Human Services: Office of the Secretary
Status: Open
Priority recommendation

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of HHS should direct the Biodefense Coordination Team to establish a resource plan to staff, support, and sustain its ongoing efforts. (Recommendation 3)

Agency: Department of Health and Human Services: Office of the Secretary
Status: Open
Priority recommendation

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of HHS should direct the Biodefense Coordination Team to clearly document agreed upon processes, roles, and responsibilities for making and enforcing enterprise-wide decisions. (Recommendation 4)

Agency: Department of Health and Human Services: Office of the Secretary
Status: Open
Priority recommendation

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Director of DHA should develop and implement plans with timeframes and specific actions needed for all 13 required elements to be reflected in the TRICARE contracts. (Recommendation 1)

Agency: Department of Defense: Office of the Under Secretary for Personnel and Readiness: Defense Health Agency
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of CMS should determine the extent to which state Medicaid programs are in compliance with federal requirements to cover MAT medications in all formats and take actions to ensure compliance, as appropriate. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of CMS should ensure that state Medicaid programs have written policies and procedures that specify the extent to which covered entities can use 340B drugs for Medicaid beneficiaries, are designed to effectively identify if 340B drugs were used, and if so, how they should be excluded from Medicaid rebate requests. The policies and procedures should be made publically available and cover FFS, managed care, and all of the dispensing methods for outpatient drugs. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS concurred with this recommendation and in August 2020 stated that it is developing guidance to state Medicaid programs directing them to strengthen policies and procedures related to 340B drugs for Medicaid beneficiaries.

Recommendation: The Administrator of HRSA should incorporate assessments of covered entities' compliance with state Medicaid programs' policies and procedures regarding the use and identification of 340B drugs into its audit process, working with CMS as needed to obtain states' policies and procedures. (Recommendation 2)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS did not concur with this recommendation and, as of August 2020, did not plan to take any actions to implement the recommendation. As noted in our report, covered entities' compliance with state Medicaid programs' policies and procedures is fundamental to preventing duplicate discounts. Thus, we continue to believe that HRSA's audit process should include an assessment of covered entities' compliance with state Medicaid programs' policies and procedures related to 340B drugs as it is necessary to identify potential duplicate discounts and to ensure covered entities' compliance with 340B Program requirements.

Recommendation: The Administrator of HRSA should require covered entities to work with affected drug manufacturers regarding repayment of identified duplicate discounts in Medicaid managed care. (Recommendation 3)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS did not concur with this recommendation and, as of August 2020, did not plan to take any actions to implement the recommendation. As noted in our report, HRSA officials told us that covered entities' obligations for preventing duplicate discounts are the same for Medicaid fee-for-service and managed care. Thus, we continue to believe that when duplicate discounts related to Medicaid managed care have been identified, the agency should require covered entities to work with manufacturers to remedy them as they do for duplicate discounts related to Medicaid fee-for-service to help ensure compliance with 340B Program requirements.

Recommendation: The Commissioner of the Social Security Administration should clarify policies and procedures to remind staff that a diagnosis of a substance use disorder is not necessary to conduct a Drug Addiction and Alcoholism evaluation. (Recommendation 1)

Agency: Social Security Administration
Status: Open

Comments: SSA agreed with this recommendation. The agency stated that it had revised related policies in February 2020, and had planned to issue guidance and video-on-demand training to further clarify policies and procedures in this area. However, SSA said its efforts to maintain mission critical activities amid the COVID-19 pandemic have delayed further implementation of this recommendation and a specific implementation date could not be provided at this time.

Recommendation: The Commissioner of the Social Security Administration should ensure that staff document their rationale for decisions involving the Drug Addiction and Alcoholism evaluation process. (Recommendation 2)

Agency: Social Security Administration
Status: Open

Comments: SSA agreed with this recommendation. The agency said it had planned to issue guidance reinforcing its policy on properly documenting decisions involving the Drug Addiction and Alcoholism evaluation process. However, SSA said its efforts to maintain mission critical activities amid the COVID-19 pandemic have delayed implementation of this recommendation and a specific implementation date could not be provided at this time.

Recommendation: The Director of ONDCP should develop and document key planning elements to help the agency meet the SUPPORT Act requirements for the 2020 National Drug Control Strategy and future Strategy iterations. These planning elements should include descriptions of resource investments, time frames, and any processes, policies, roles, and responsibilities needed to address each requirement. (Recommendation 1)

Agency: Executive Office of the President: Office of National Drug Control Policy
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Director of ONDCP should—after developing and documenting key planning elements to meet the SUPPORT Act requirements—routinely implement an approach, based on these planning elements, to meet the requirements for the 2020 National Drug Control Strategy and future Strategy iterations. (Recommendation 2)

Agency: Executive Office of the President: Office of National Drug Control Policy
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Director of ONDCP should develop and document key planning elements to help the agency meet the SUPPORT Act requirements to establish a Drug Control Data Dashboard that would include descriptions of resource investments, time frames, and any processes, policies, or roles, and responsibilities needed to address this requirement. (Recommendation 3)

Agency: Executive Office of the President: Office of National Drug Control Policy
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Director of ONDCP should—after developing and documenting key planning elements—implement an approach, based on these planning elements, to meet the SUPPORT Act requirements to establish a Drug Control Data Dashboard. (Recommendation 4)

Agency: Executive Office of the President: Office of National Drug Control Policy
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Assistant Secretary of Labor for the Employee Benefits Security Administration should evaluate whether targeted oversight in response to information received is effective for ensuring compliance with MH/SU parity requirements. If this evaluation determines the current targeted oversight approach results in significant program risks, the Employee Benefits Security Administration should develop a plan to more effectively enforce MH/SU parity requirements and if necessary seek additional oversight authority, as warranted. (Recommendation 1)

Agency: Department of Labor: Employee Benefits Security Administration
Status: Open

Comments: DOL agreed with this recommendation. In February 2020, DOL reported that its Employee Benefits Security Administration plans to evaluate its targeted approach to MH/SU parity enforcement. When we confirm what actions DOL has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of CMS should evaluate whether targeted oversight in response to information received is effective for ensuring compliance with MH/SU parity requirements for non-federal governmental plans. If this evaluation determines the current targeted oversight approach results in significant program risks, CMS should develop a plan to more effectively enforce MH/SU parity requirements and if necessary seek additional oversight authority, as warranted. (Recommendation 2)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS agreed with this recommendation. In August 2020, HHS reported that CMS has developed a two-part evaluation to determine whether targeted oversight of non-federal governmental plans is effective for enforcing MH/SU parity requirements. According to HHS, this evaluation will include (1) a review of non-federal governmental plan documents for compliance with MH/SU parity requirements and (2) a survey of state enforcement authority and regulatory best practices for ensuring MH/SU parity compliance. As of August 2020, HHS reported that the first part of the CMS evaluation is underway.

Recommendation: The Administrator of HRSA should ensure that the information it uses to verify nonprofit status for all nongovernmental hospitals that participate in the 340B Program is reliable—for example, by requiring and reviewing the submission of official documentation hospitals must already maintain or by ensuring the reliability of the data the agency uses. (Recommendation 1)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS concurred with this recommendation and in June 2020, reiterated that HRSA believes that the information it uses to determine nonprofit status is reliable, because hospital administrators attest to its accuracy. However, as discussed in our report, neither HRSA nor the agency that collects the data has evaluated the reliability of the data for verifying nonprofit status. Without ensuring it is using reliable information, HRSA cannot effectively determine if nongovernmental hospitals participating, or seeking to participate, in the 340B Program meet the statutory eligibility requirements.

Recommendation: The Administrator of HRSA should implement a process to verify that every nongovernmental hospital that participates in the 340B Program has a contract with a state or local government as required by statute. (Recommendation 2)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS did not concur with this recommendation and, as of June 2, 2020, did not plan to take any actions to implement the recommendation. HHS noted that requiring all covered entities to submit a state or local government contract would create a significant burden for covered entities. However, as we noted in our report, HRSA already requires hospitals to maintain copies of their state or local government contracts. Therefore, it is unclear how implementing a process to verify the existence of those contracts would represent a significant burden. Without this information, HRSA does not have reasonable assurance that nongovernmental hospitals have the statutorily required contracts to participate in the 340B Program.

Recommendation: The Administrator of HRSA should provide more specific guidance for 340B Program auditors on how to determine if nongovernmental hospitals' contracts with state and local governments require the provision of health care services to low-income individuals not eligible for Medicaid or Medicare. (Recommendation 4)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS concurred with this recommendation and in June 2020, indicated that HRSA had updated its audit guidance and procedures to more clearly specify that contracts must contain requirements for the provision of health care services to low-income individuals. However, these documents do not contain any specific guidance on how auditors are to evaluate whether contracts require these services. Without more specific guidance for auditors' review of contracts, HRSA lacks reasonable assurance that the audits are appropriately identifying deficiencies in nongovernmental hospitals' contracts with state or local governments.

Recommendation: The Administrator of HRSA should require nongovernmental hospitals participating in the 340B Program to demonstrate that they have contracts with state or local governments in effect prior to the beginning of their audits' periods of review and should apply consistent and appropriate consequences for hospitals that are unable to do so. (Recommendation 6)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS concurred with this recommendation. As noted in our report, HRSA updated its draft audit procedures for fiscal year 2020 audits in September 2019 to specify that auditors should look for effective dates that cover the entire audit period. While this is an important step, HRSA must also show that it has ceased accepting retroactive contract documentation, and has applied consistent and appropriate consequences when auditors find that nongovernmental hospitals did not have contracts in effect prior to the beginning of their audit periods. As of June 2020, HHS indicated that HRSA had not taken these actions. Allowing hospitals that are unable to demonstrate that they have contracts in place that cover their audits' periods of review to continue to participate without consequences undermines the effectiveness of HRSA's audit process and increases the risk that ineligible hospitals will receive discounts under the program.

Recommendation: The Director of DHA should define data sharing requirements with more specificity in its transition guidance for outgoing and incoming contractors, including the time period covered and the types of data that must be shared. (Recommendation 1)

Agency: Department of Defense: Office of the Under Secretary for Personnel and Readiness: Defense Health Agency
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Director of DHA should revise the process the agency has in place for resolving issues raised between contractors during transition to ensure such issues are resolved within time frames that will not adversely affect the transition schedule. (Recommendation 2)

Agency: Department of Defense: Office of the Under Secretary for Personnel and Readiness: Defense Health Agency
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Director of DHA should incorporate lessons learned from this transition and ensure that subject matter experts review PRV/PRAV requirements and performance guarantees prior to the issuance of the request for proposal for the next transition. These requirements should be reviewed to ensure their feasibility and effectiveness for assessing contractor readiness. (Recommendation 3)

Agency: Department of Defense: Office of the Under Secretary for Personnel and Readiness: Defense Health Agency
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: Congress should consider giving CMS authority to establish additional enforcement remedies for hospices that do not meet federal health and safety requirements. (Matter for Consideration 1)

Agency: Congress
Status: Open

Comments: In October 2019, we suggested that Congress should consider giving CMS authority to establish additional enforcement remedies for hospices that do not meet federal health and safety requirements. As of June 2020, Congress has not implemented this suggestion.

Recommendation: The Administrator of CMS should incorporate the use of additional information, such as quality measures or other information that could identify potential quality of care issues, into its survey process for overseeing hospice providers. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS concurred with this recommendation. In May 2020, HHS said CMS is evaluating ways in which the Hospice Consumer Assessment of Health Providers and Systems (CAHPS) survey data can be used to inform surveys of hospice providers. HHS also said CMS intends to incorporate use of the current Hospice Quality Reporting Program (HQRP) measurement data into the survey process to provide additional items that inform a surveyor's evaluation of a hospice provider. HHS noted that these changes would be incorporated into a more comprehensive update to the survey process to target providers and areas where risk of noncompliance is greatest. HHS projected the updated process would be implemented by the end of the first quarter of calendar year 2021. In order for us to close the recommendation, CMS has to implement an updated survey process that incorporates the use of additional information that could identify potential quality of care issues, such as that described above.

Recommendation: The Commissioner of FDA should consult with TTB and CBP to determine and document—for example in Memorandums of Understanding or other written agreements—procedures and time frames for FDA to receive quality data from TTB and CBP that will allow FDA to complete its reconciliation process in a timely manner. (Recommendation 1)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: According to HHS, FDA officials met with CBP officials in September, 2019, and with TTB officials in October, 2019, to discuss the development of procedures and time frames for FDA to receive data from the respective entities that will allow FDA to complete its reconciliation process in a timely manner . In August, 2020, FDA reported that the agency had provided a draft agreement to both CBP and TTB subsequent to these meetings, but that agreements had not yet been finalized. Because FDA is still in the process of developing written agreements with CBP and TTB, the recommendation remains open.

Recommendation: The Administrator of CMS should expand its review of states' implementation of the provider screening and enrollment requirements to include states that have not made use of CMS's optional consultations. Similar to CMS's contractor site visits, such reviews should include any necessary steps to address areas of noncompliance for all types of enrolled providers, including those under contract with managed care organizations. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open
Priority recommendation

Comments: CMS concurred with our recommendation. In February 2020, CMS told us that it plans to reach out to states that have not yet participated in its optional consultations to discuss their progress towards implementing provider screening and enrollment requirements, and outline steps that the states should take to come into full compliance with them. In order to fully address this recommendation CMS would need to review all states' implementation of the provider screening and enrollment requirements, including states that have not made use of CMS's optional consultations. As such, this recommendation remains open until CMS provides evidence that it has assessed the compliance of all states; we will continue to monitor CMS's progress.

Recommendation: The Administrator of CMS should annually monitor progress toward addressing any areas of noncompliance related to the provider screening and enrollment requirements for any state with one or more corrective action plans. (Recommendation 2)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: As of February 2020, HHS officials have not informed us of any actions taken to implement this recommendation. We will update the status of this recommendation when we receive additional information

Recommendation: The Administrator of CMS should require states to submit and make public projections of administrative costs when seeking approval of demonstrations, including those with work requirements and all other demonstrations. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS did not concur with this recommendation in its September 2019 comments on the report. We maintain that the recommendation is valid because requiring states to make public information about administrative costs would help to ensure that demonstration proposals provide sufficient information to ensure meaningful public input.

Recommendation: The Administrator of CMS should account for the administrative costs of demonstrations, including those with work requirements and all other demonstrations, when assessing whether demonstrations are budget neutral. (Recommendation 2)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS did not concur with this recommendation in its September 2019 comments on the report. We maintain that the recommendation is valid because including administrative costs in its assessments will help HHS ensure that demonstrations are budget neutral.

Recommendation: The Administrator of CMS should assess the risks of providing federal funds for costs to administer work requirements that are not allowable and should respond to risks by improving oversight procedures, as warranted. This assessment should consider risks related to costs for information systems, beneficiary supports, and managed care. (Recommendation 3)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS did not concur with this recommendation in its September 2019 comments on the report. We maintain that the recommendation is valid and that assessing these risks of providing federal funds for costs that are not allowable and improving oversight, as warranted, would help HHS to ensure the integrity of the Medicaid program.

Recommendation: The VA Under Secretary of Health should use workload data from the most recently completed fiscal year as part of the models that inform VISNs' and medical centers' general purpose funding needs, when doing so would not significantly delay the allocation of funds. (Recommendation 1)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open

Comments: April 2020: GAO will update the status of this recommendation when VA provides additional information.

Recommendation: The VA Under Secretary of Health should establish a formal process to document VHA's review of VISNs' adjustments to medical center allocation levels. (Recommendation 2)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open

Comments: April 2020: GAO will update the status of this recommendation when VA provides additional information.

Recommendation: The VA Under Secretary of Health should revise VHA's existing guidance to require VISNs to provide information on how they determined how much and for what reasons they made adjustments to medical center allocation levels. (Recommendation 3)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open

Comments: April 2020: GAO will update the status of this recommendation when VA provides additional information.

Recommendation: The VA Under Secretary of Health should revise its existing guidance to require VISNs—in conjunction with medical centers—to develop and submit approaches to improve efficiency at medical centers with declining workload that received adjusted funding levels. These approaches could include adjusting the level of services offered. (Recommendation 4)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open
Priority recommendation

Comments: April 2020: GAO will update the status of this recommendation when VA provides additional information.

Recommendation: The VA Under Secretary of Health should require VISNs to provide explanations on the amount of funds redistributed between VISNs and medical centers and VHA to document its review of these redistributions. (Recommendation 5)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open

Comments: April 2020: GAO will update the status of this recommendation when VA provides additional information.

Recommendation: ASPR should develop a response personnel strategy to ensure, at a minimum, a lead ASPR liaison officer is consistently at the local emergency operations center(s) during an emergency support functions (ESF) #8 response and another liaison, if not more, is at strategic location(s) in the area. (Recommendation 1)

Agency: Department of Health and Human Services: Office of the Assistant Secretary for Preparedness and Response
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: As ASPR finalizes its federal patient movement framework, the agency should exercise the framework with its National Disaster Medical System (NDMS) partners to ensure that patients evacuated through NDMS will be consistently tracked from the start of their evacuation. (Recommendation 2)

Agency: Department of Health and Human Services: Office of the Assistant Secretary for Preparedness and Response
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: ASPR should put controls in place to ensure data on all NDMS evacuated patients are complete and accurate. (Recommendation 3)

Agency: Department of Health and Human Services: Office of the Assistant Secretary for Preparedness and Response
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: ASPR Region II should revise its Incident Response Plans for the territories to include strategies for providing chronic and primary care in isolated communities. These strategies could include the incorporation of Federally Qualified Health Centers and other local health clinics as part of a response. (Recommendation 4)

Agency: Department of Health and Human Services: Office of the Assistant Secretary for Preparedness and Response
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: ASPR should work with support agencies to develop and finalize memorandums of agreement that include information on the capabilities and limitations of these agencies to meet ESF#8 core capabilities. (Recommendation 5)

Agency: Department of Health and Human Services: Office of the Assistant Secretary for Preparedness and Response
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: ASPR should develop a strategy demonstrating how it ESF#8 core capabilities can be provided through HHS and ESF#8 support agencies if DOD's capacity to respond is limited. (Recommendation 6)

Agency: Department of Health and Human Services: Office of the Assistant Secretary for Preparedness and Response
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: ASPR should take steps to ensure the perspectives of key external parties are incorporated in the development of HHS's after-action reviews, following future ESF#8 activations. (Recommendation 7)

Agency: Department of Health and Human Services: Office of the Assistant Secretary for Preparedness and Response
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of CMS should, to the extent feasible, maintain more complete information on both the total amount of funding allocated for quality measurement activities and the extent to which this funding supports each of its quality measurement strategic objectives. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of CMS should develop and implement procedures to systematically assess the measures it is considering developing, using, or removing in terms of their impact on achieving CMS's strategic objectives and document its compliance with those procedures. (Recommendation 2)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of CMS should develop and use a set of performance indicators to evaluate the agency's progress towards achieving its quality measurement strategic objectives. (Recommendation 3)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of the VA should direct the Under Secretary for Health to collect complete staffing data for the Family Caregiver Program that includes Caregiver Support Program Office funded staff, VAMC funded staff, and staff that assist the program as a collateral duty at each VAMC. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open

Comments: VA concurred with this recommendation. The Veterans Health Administration (VHA) has reported that the Caregiver Support Program Office had identified a solution for identifying VHA Family Caregiver Program staff in the Human Resource (HR) Smart system. VHA reported that current full- and part-time employees funded by the Caregiver Support Program Office will be identified with a specific specialty code in HR Smart. However, as of April 2020, this capability was not yet available in HR Smart and staffing for the program continued to be manually updated and tracked. Further, the proposed use of HR Smart will still not result in complete information that the Caregiver Support Program Office can use to track all staff who support the program because according to VHA, staff that assist the program as a collateral duty and VAMC-funded staff who support the program will not be tracked through HR Smart. As of July 2020, this recommendation remains open pending further updates from VHA.

Recommendation: The Secretary of the VA should direct the Under Secretary for Health to establish a process to ensure that the Family Caregiver Program staffing data that are collected and reported to the Caregiver Support Program Office are accurate. (Recommendation 2)

Agency: Department of Veterans Affairs
Status: Open

Comments: VHA concurred with this recommendation. In February 2020, the Veterans Health Administration (VHA) reported that the Caregiver Support Program Office had identified a solution for identifying full-time VHA Family Caregiver Program staff in the Human Resource (HR) Smart system through the use of a specific specialty code. VHA reported that once implemented, the use of the HR SMART specialty code would provide more accurate information regarding staffing. In April 2020, VHA stated that were would also be a static field called "position skill type" that would track positions with a skill type category of caregiver and that Veterans Integrated Service Network (VISN) leads for the Family Caregiver Program would use this field to cross check the new specialty code and identify and correct any reporting inconsistencies. As of July 2020, this recommendation remains open pending further updates from VHA.

Recommendation: The Administrator of CMS should work with states and relevant federal agencies to collect accurate and complete data on blood lead screening for Medicaid beneficiaries in order to ensure that CMS is able to monitor state compliance with its blood lead screening policy, and assist states with planning improvements to address states' compliance as needed. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open
Priority recommendation

Comments: In June 2020, Centers for Medicare & Medicaid Services (CMS) officials said that obtaining complete data on blood lead screenings for children enrolled in Medicaid will not be possible, but that the agency is committed to improving the accuracy and completeness of the data. For example, in February 2020, CMS reported that the agency is planning to use a new data system-as states meet certain data quality and completeness benchmarks for the system-to generate the report that includes states' blood lead screening data. CMS stated that this will improve the agency's and states' ability to assess gaps in blood lead screening data. This is a positive step, yet any new data system will also need to consider how to help address known limitations in the current blood lead screening data, such as the under-counting of blood lead screening tests not paid for by Medicaid. To implement this recommendation, CMS should address limitations in blood lead screening data to better monitor compliance with the agency's blood lead screening policy.

Recommendation: The Administrator of CMS should regularly assess the appropriateness of performance measures and targets for the EPSDT benefit, and take any necessary actions to ensure their relevance and use, including adding, changing, or removing measures, or targets, and regularly communicating performance measures and targets to states. (Recommendation 2)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: In June 2020, CMS officials reiterated that they do not concur with this recommendation, in part because the agency does not have the authority to set binding targets for every EPSDT measure. As we stated in our report, our recommendation does not assume that targets should be set for every measure--rather, that CMS needs to regularly assess the appropriateness of performance measures and targets for the EPSDT benefit and communicate them to states. This includes assessments of the CMS-416 performance measures, such as the participant and screening ratios. which CMS officials acknowledge have limitations.

Recommendation: The Administrator of CMS should conduct regular evaluations of state performance by comparing states' performance measurement data with CMS's EPSDT targets to identify gaps in states' performance and areas for improvement. (Recommendation 3)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: In June 2020, CMS officials reiterated that they do not concur with this recommendation, in part because the agency provides states with information about their performance on ESPDT measures reported on the Child Core Set, including a state's performance relative to other states' performance. We noted the limitations of this approach in our report; descriptions of a state's performance relative to other states is subject to change over time. For example, because the median is the midpoint of all states' performance, it ensures that half of states will not meet it, regardless of their individual performance. A fixed target--or targeted improvement goal, such as the one developed as part of the Oral Health Initiative--would provide states with the opportunity to measure performance over prior years' results, which is a more meaningful measure that all states can strive to achieve.

Recommendation: The Administrator of CMS should assist states with planning needed improvements, including providing focused assistance, to resolve gaps in states' performance in meeting CMS's EPSDT targets. (Recommendation 4)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: In June 2020, CMS officials reiterated that they do not concur with this recommendation, in part because the agency does not believe that it is productive or appropriate to set targets for every EPSDT measure. As we stated in our report, our recommendation does not assume that targets should be set for every measure. However, developing additional targets on performance measures critical to beneficiaries' health and well-being could help improve oversight of EPSDT. Targeted technical assistance could be valuable for CMS to provide to states after identifying gaps in states' performance relative to EPSDT targets. Doing so would allow CMS to share additional strategies to help states plan and implement needed improvements.

Recommendation: The Administrator of CMS should develop a plan with time frames and interim milestones for using T-MSIS data to generate the necessary data from the Child Core Set to improve EPSDT oversight and streamline state reporting. (Recommendation 6)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: In June 2020, CMS officials said that they are currently exploring the feasibility of using T-MSIS data to generate certain Child Core Set measures. Specifically, the agency is conducting a pilot with five Child Core Set measures. CMS officials said that they will use the pilot's results to determine the timeline for generating the additional Child Core Set measures through T-MSIS. GAO will continue to follow the agency's progress on this activity.

Recommendation: The Administrator of CMS should ensure the agency's Medicaid third-party liability guidance is consistent with federal law related to

• the requirement for states to apply cost avoidance procedures to claims for labor, delivery, and postpartum care services,
• the requirement for states to make payments without regard to potential third-party liability for pediatric preventive services unless the state has made a determination related to cost-effectiveness and access to care that warrants cost avoidance for 90 days, and
• state flexibility to make payments without regard to potential third-party liability for pediatric services provided to child support enforcement beneficiaries. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: On November 14, 2019, CMS issued an Informational Bulletin providing further guidance to Medicaid Bipartisan Budget Act (BBA) of 2018 and changes to Medicaid Provisions Passed in April 2019-Third Party Liability in Medicaid and CHIP. The intent of the information Bulletin is to further clarify CMS guidance issued in the agency's June 2018 Bulletin on key provisions related to third party liability in Medicaid and CHIP. The Bulletin also addresses April 2019 changes to the Bipartisan Budget Act of 2013. The bulletin clarifies CMS guidance on two of the three issues we identified in our 2019 report. The bulletin notes that (1) effective February 9, 2018 a state is required to use standard coordination of benefits cost avoidance when processing claims for prenatal services which now includes labor and delivery and postpartum care claims, and (2) effective October 1, 2019, a state is required to make payments without regard to third party liability for pediatric preventive services unless the state has made a determination related to cost-effectiveness and access to care that warrants cost avoidance for 90 days. However, with regard to the third issue, the bulletin notes that, effective April 18, 2019, a state is allowed 100 days to pay claims related to child support enforcement, but does not note that states may choose to make payment within 30 days, if the state determines doing so is cost-effective and necessary to ensure access to care. We will continue to monitor CMS guidance on payments related to child support enforcement to assess whether the recommendation is fully implemented.

Recommendation: The Administrator of CMS should determine the extent to which state Medicaid programs are meeting federal third-party liability requirements and take actions to ensure compliance as appropriate. Such actions can include ensuring that state plans reflect the law. (Recommendation 2)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: As of February 2020, we are unaware of any actions taken by CMS to implement this recommendation.

Recommendation: The Under Secretary for Health should document same-day services objectives and develop performance goals and related performance measures to facilitate the periodic assessment of the impact of same-day services on veterans' access to care. (Recommendation 1)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should take additional steps to address inconsistency in its written comments to generic drug applicants—including the clarity of writing and the content of comments—among reviewers, such as requiring additional training for reviewers. (Recommendation 1)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: FDA concurred with this recommendation and is taking steps to implement it. As of August 2020, FDA stated that it is evaluating methods to improve the clarity and content of primary reviewer comments by developing and providing training and work aids on written communication to ensure that FDA conveys deficiency comments in a clear and consistent manner to applicants. FDA noted that best practices on ensuring consistency in deficiency comments will be shared with primary reviewers. In addition, FDA stated that the agency is reviewing current training and providing coaching for secondary reviewers to exchange, compare, discuss, and improve the content and consistency of common deficiencies communicated in primary reviewer comments.

Recommendation: The Commissioner of FDA should assess the extent to which the timing of brand-name drug companies' drug labeling changes affect the approval of generic drug applications in the first review cycle, and take steps, as appropriate, to limit the effect of brand-name drug labeling changes on pending generic drug applications. (Recommendation 2)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: FDA concurred with this recommendation and is taking steps to implement it. As of August 2020, FDA reported that it is identifying and assessing examples of applications in which the brand-name drug company submitted a supplemental application for a labeling change that impacted the timeline of the generic drug approval. After gathering data, FDA officials stated that they will assess what particular actions could address this issue, including whether FDA has the authority to take any such identified actions.

Recommendation: The Secretary of the Treasury, as Chairperson of the Boards of Trustees, should work with the other trustees to take steps—in consultation with the chief actuaries of SSA and CMS—to improve the management of the report development schedule in order to provide the Trustees reports to Congress by the statutory deadline. These steps could include regularly updating the schedule using actual progress and archiving the final iteration of the schedules. (Recommendation 1)

Agency: Department of the Treasury
Status: Open

Comments: Treasury agreed with the recommendation and said they would work with the other trustees to take steps to improve the management of the report development schedule.

Recommendation: The Secretary of the Treasury, as Chairperson of the Boards of Trustees, should work with the other trustees to establish a policy to inform Congressional committees of jurisdiction when the trustees determine that the reports are expected to miss the issuance deadline. This outreach should include 1) the factors that are contributing to delays, and 2) the reports' expected issuance dates. (Recommendation 2)

Agency: Department of the Treasury
Status: Open

Comments: Treasury agreed with this recommendation. The agency said it would explore the potential for a policy to inform Congressional committees of jurisdiction when the trustees determine that the reports are expected to miss the April 1 deadline.

Recommendation: The Secretary of VA should direct the Under Secretary for Health and the Assistant Secretary for Information and Technology/Chief Information Officer to develop and implement a methodology for reliably identifying and reporting the total costs of VistA. The methodology should include steps to identify the definition of VistA and what is to be included in its sustainment activities, as well as ensure that comprehensive costs are corroborated by reliable data. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open

Comments: The Department of Veterans Affairs (VA) generally agreed with our conclusions and concurred with our recommendation. In a January 2020 update, the department described steps it planned to take to address the recommendation including establishing a team of experts to formulate a comprehensive taxonomy for VistA and all of its components, identifying authoritative and reliable data sources to assign costs to those components, and developing a methodology for ongoing cost tracking and reporting. The department expects these steps to be implemented by September 30, 2020. We will continue to monitor the department's progress to address this recommendation.

Recommendation: The Under Secretary of Health should require that all failures to meet quality standards are cited as deficiencies on SVH inspections. (Recommendation 2)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open

Comments: VA concurred with this recommendation and, as of July 2020, had taken some initial steps to address the recommendation such as modifying the SVH contractor's contract to stop the practice of using 'recommendations' for low-level deficiencies and beginning the process of revising a VA policy to address this practice.

Recommendation: The Under Secretary of Health should develop guidance for Veterans Affairs Medical Center staff conducting optional onsite CNH reviews. (Recommendation 3)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open

Comments: VA concurred in principle with this recommendation and indicated in January 2020 that it had begun taking actions to address this recommendation such as developing a memo of clarification and planning the release of additional guidance for staff.

Recommendation: The Under Secretary of Health should provide information on the quality of all SVHs that is comparable to the information provided on the other nursing home settings on its Access to Care website. (Recommendation 4)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open

Comments: VA concurred in principle and, as of July 2020, had begun taking some steps to address this recommendation such as exploring options for presenting SVH quality measure data.

Recommendation: The Under Secretary for Health should develop a process to assess the overall performance of VISNs in managing and overseeing medical centers. (Recommendation 1)

Agency: Department of Veterans Affairs: Office of the Under Secretary for Health
Status: Open

Comments: VHA concurred with our recommendation. In December 2019, VHA reported efforts to modernize its governance structure with a newly created VHA Governance Board. In February 2020, VHA reported additional efforts to charter governance councils to support the VHA Governance Board and work continues to develop these councils and responsibilities, with a target completion date of September 2020. For closure, VHA will need to provide documentation that shows the process developed to assess the overall performance of VISNs in managing medical centers. Providing documentation explaining how these governance structures plan to assess overall VISN performance, including any metrics or tools that would be used as a part of this process, would be useful in determining if this recommendation can be considered for closure.

Recommendation: The Under Secretary for Health should establish a comprehensive policy that clearly defines VISN roles and responsibilities for managing and overseeing medical centers. (Recommendation 2)

Agency: Department of Veterans Affairs: Office of the Under Secretary for Health
Status: Open
Priority recommendation

Comments: VHA concurred in principle with our recommendation. In December 2019, VHA told us they were working to streamline reporting structures at all levels, focusing on governance and workflow, including defining consistent levels of authority. In February 2020, VHA told us they were realigning Central Office in addition to making changes to the governance structure to support clarity of roles and responsibilities. VHA plans to crosswalk existing policies to the new structure and organizations, with a target completion date of September 2020. Following completion of VHA's efforts to streamline Central Office and ensure reporting structures are in place, VHA will need to provide policy documentation that clearly outlines VISN roles and responsibilities, including how these governance structures plan to define the VISN's roles and responsibilities. While governance and reporting structures are a first step, it is important for roles and responsibilities to be clearly outlined in a policy vehicle, as VHA requires the use of policy to assign responsibilities for executing a course of action to individuals or groups.

Recommendation: The Under Secretary for Health should establish a process to routinely oversee VISN staffing, to include ensuring VISNs are consistent with VHA's standardized VISN staffing levels and positions, and documenting the rationale for approving staffing that does not adhere to VHA's standardized approach. (Recommendation 3)

Agency: Department of Veterans Affairs: Office of the Under Secretary for Health
Status: Open

Comments: VHA concurred with our recommendation. In December 2019, VHA reported its office for Manpower Management began reviewing changes to VISN organizational structure and positions. In February 2020, VHA provided GAO with the guidance for VISN staffing and a draft Manpower Management directive, with target completion date of May 2020 for approval. For closure, VHA should provide the approved VA Directive 5010 documentation outlining the process developed to routinely oversee VISN staffing, including efforts by the DUSHOM in partnership with Workforce Management and Consulting and Manpower and Management, such as policy directives, organizational charts, amongst others.

Recommendation: The Veterans Health Administration should disseminate guidance for VISNs and VAMCs that more clearly reflects its expectation that mental health providers in specialty care should record mental health treatment plans within veterans' medical records in an easily identifiable way. (Recommendation 1)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open

Comments: VHA concurred with this recommendation and provided an update on its progress in implementing it. In December 2019, VHA reported that it had developed a new memorandum regarding mental health treatment planning that explicitly states the requirement for mental health providers in specialty care to record mental health treatment plans as a separate, easily identifiable document in the medical record. According to this memorandum, these treatment plans are expected to ensure that it is clear what treatment is being provided, that different treatments were considered, and that ongoing assessments are used to determined whether treatment changes are needed for the patient. VHA also reported that the memorandum states that facilities must either use the current treatment planning software or another method to create such a plan. Finally, VHA noted that the memorandum requires VAMCs to attest to full implementation of these requirements. According to VHA, the memorandum was distributed in May 2019 and the implementation process is currently underway across VAMCs. As of March 2020, this recommendation remains open pending further updates from VHA.

Recommendation: The Veterans Health Administration should develop and implement an approach for monitoring treatment plans for veterans with mental health conditions to ensure that such plans include documentation that different evidence-based treatment options were considered. (Recommendation 2)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open
Priority recommendation

Comments: VHA concurred with this recommendation and provided an update on its progress in implementing it. In December 2019, VHA reported that it had developed a new memorandum regarding mental health treatment planning that explicitly states the requirement for mental health providers in specialty care to record mental health treatment plans that include (among other things) an indication that different treatments were considered. VHA stated that the memorandum requires VAMCs to implement ongoing chart reviews to ensure providers were meeting treatment planning expectations. Specifically, VHA stated that the memorandum requires all VAMCs to ensure that each licensed independent provider had 5 treatment plans reviewed biannually to determine whether treatment planning expectations were achieved, including whether different evidence-based treatments were considered. Finally, VHA noted that the memorandum requires VAMCs to attest to full implementation of this process. According to VHA, the memorandum was distributed in May 2019 and the implementation of this process is currently underway across VAMCs. As of March 2020, this recommendation remains open pending further updates from VHA.

Recommendation: The administrator of CMS should require that abuse and perpetrator type be submitted by state survey agencies in CMS's databases for deficiency, complaint, and facility-reported incident data, and that CMS systematically assess trends in these data. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open
Priority recommendation

Comments: HHS concurred with this recommendation. In February 2020, HHS said CMS is developing the ability to review survey trends related to alleged perpetrator and alleged abuse types and aims to implement this recommendation by December 2020.

Recommendation: The administrator of CMS should develop and disseminate guidance—including a standardized form—to all state survey agencies on the information nursing homes and covered individuals should include on facility-reported incidents. (Recommendation 2)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS concurred with this recommendation. In February 2020, HHS said CMS will list the elements that all nursing homes should report to state agencies and aims to implement this recommendation by December 2020.

Recommendation: The administrator of CMS should require state survey agencies to immediately refer complaints and surveys to law enforcement (and, when applicable, to Medicaid Fraud Control Units (MFCU)) if they have a reasonable suspicion that a crime against a resident has occurred when the complaint is received. (Recommendation 3)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open
Priority recommendation

Comments: HHS concurred with this recommendation. In February 2020, HHS said CMS will require state survey agencies to immediately refer complaints upon receipt and surveys to law enforcement (and, when applicable, to Medicaid Fraud Control Units) if they have a reasonable suspicion that a crime against a resident has occurred and aims to implement this requirement by December 2020.

Recommendation: The administrator of CMS should conduct oversight of state survey agencies to ensure referrals of complaints, surveys, and substantiated incidents with reasonable suspicion of a crime are referred to law enforcement (and, when applicable, to MFCUs) in a timely fashion. (Recommendation 4)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS concurred with this recommendation. In February 2020, HHS said CMS will revise guidance to ensure state survey agencies will investigate and track incidents of abuse and neglect and report substantiated findings to local law enforcement. CMS aims to implement this recommendation by December 2020.

Recommendation: The administrator of CMS should develop guidance for state survey agencies clarifying that allegations verified by evidence should be substantiated and reported to law enforcement and state registries in cases where citing a federal deficiency may not be appropriate. (Recommendation 5)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS concurred with this recommendation. In February 2020, HHS said CMS will provide clarification to the state survey agencies regarding the definition of substantiated and when cases need to be referred to law enforcement. CMS aims to implement this recommendation by December 2020.

Recommendation: The administrator of CMS should provide guidance on what information should be contained in the referral of abuse allegations to law enforcement. (Recommendation 6)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS concurred with this recommendation. In February 2020, HHS said it will provide guidance to state agencies and nursing homes on identifying and reporting potential abuse and neglect of residents and will develop a list of standardized elements that should be included when reporting an abuse allegation to law enforcement. HHS aims to implement this recommendation by July 2020.

Recommendation: The Secretary of Defense should direct DHA to ensure that MTFs' referral management center staff are trained to process and accurately document information in MHS Genesis about specialty care referrals, including the receipt of CLRs, the submission of referral results, and the closure of referrals. (Recommendation 1)

Agency: Department of Defense
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Defense should direct DHA to ensure that MHS Genesis is configured to produce reports that accurately reflect the use and outcomes of specialty care referrals. (Recommendation 2)

Agency: Department of Defense
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of CMS should develop and communicate a policy that defines when changes to a pending section 1115 demonstration application are considered major and should prompt a new review of the application against the transparency requirements applicable to the pending application. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: In response to this recommendation, HHS stated that existing regulations permit CMS at its discretion to direct an additional public comment period when states make a modification to an application that substantially changes the design. In July 2020, CMS officials said the agency would continue to exercise its regulatory discretion as needed and planned no further action in response to this recommendation. In light of past CMS decisions to not require states to first seek public comment before submitting major changes to their demonstration applications, we maintain that a policy is needed defining when changes are considered major and should prompt a new review of the application against transparency requirements. We will continue to monitor CMS's actions in this area.

Recommendation: The Administrator of CMS should develop and communicate a policy whereby applications for section 1115 demonstration amendments that may have significant impact are subject to transparency requirements comparable to those for new demonstrations and extensions. (Recommendation 2)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open
Priority recommendation

Comments: HHS stated that it plans to implement a policy applying state public input processes and application criteria to amendments proposing significant or substantial changes in the same manner as for new demonstrations. In July 2020, CMS stated the agency plans to develop criteria for determining whether an amendment application proposes a substantial change to an existing demonstration and to include this in guidance by early 2021. We will continue to monitor CMS's actions in this area and will close this recommendation once this policy guidance is issued.

Recommendation: CMS should evaluate state survey agency processes in all states to ensure all state survey agencies are meeting federal requirements that state survey agencies are responsible for investigating complaints and facility-reported incidents alleging abuse in nursing homes, and that the results of those investigations are being shared with CMS. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS concurred with this recommendation. As of November 2019, HHS officials have not informed us of actions taken to complete implementation of this recommendation. We will update the status of this recommendation when we receive additional information.

Recommendation: CMS should identify options for capturing information from Oregon's APS investigations of complaints and facility-reported incidents of abuse and incorporate this information into oversight of Oregon nursing homes. (Recommendation 2)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS concurred with this recommendation. As of November 2019, HHS officials have not informed us of actions taken to complete implementation of this recommendation. We will update the status of this recommendation when we receive additional information.

Recommendation: The Administrator of CMS should institute a process to routinely assess, and take steps to ensure, as appropriate, that Medicare and Medicaid documentation requirements are necessary and effective at demonstrating compliance with coverage policies while appropriately addressing program risks. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open
Priority recommendation

Comments: The Department of Health and Human Services concurred with this recommendation. In February 2020, the Centers for Medicare & Medicaid Services (CMS) noted that it had clarified and amended several Medicare documentation requirements as part of an agency initiative to assess such requirements. CMS further stated that Medicaid documentation requirements are generally established at the state level, and that the agency has taken steps to identify best practices for documentation requirements and share them with states. However, we believe that CMS still needs to take steps to assess documentation requirements in both programs to better understand how the variation in the programs' requirements affects estimated improper payment rates. Without an assessment of how the programs' documentation requirements affect estimates of improper payments, CMS may not have the information it needs to ensure that Medicare and Medicaid documentation requirements are effective at demonstrating compliance and appropriately address program risks.

Recommendation: The Administrator of CMS should take steps to ensure that Medicaid medical reviews provide robust information about and result in corrective actions that effectively address the underlying causes of improper payments. Such steps could include adjusting the sampling approach to reflect state-specific program risks, and working with state Medicaid agencies to leverage other sources of information, such as state auditor and the Department of Health and Human Services' Office of the Inspector General findings. (Recommendation 2)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: The Department of Health and Human Services (HHS) did not concur with this recommendation. As of September 2020, HHS has stated that it does not plan to implement this recommendation because the agency believes the resource requirement is not justified based on the potential improper payment findings. HHS further stated that the agency already uses a variety of sources to identify and take corrective actions to address underlying causes of improper Medicaid payments. However, we found that the Centers for Medicare & Medicaid Services (CMS) and state Medicaid agencies are expending time and resources developing and implementing corrective actions that may not be representative of the underlying causes of improper payments in their states. Without robust information to effectively identify the underlying causes of improper payments, CMS and state Medicaid agencies may not develop corrective actions that effectively address Medicaid program risks.

Recommendation: The Administrator of CMS should take steps to minimize the potential for Payment Error Rate Measurement (PERM) medical reviews to compromise fraud investigations, such as by directing states to determine whether providers selected for PERM medical reviews are also under fraud investigation and to assess whether such reviews could compromise investigations. (Recommendation 3)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: The Department of Health and Human Services (HHS) concurred with this recommendation. In October 2019, the Centers for Medicare & Medicaid Services (CMS) updated Medicaid Payment Error Rate Measurement (PERM) program guidance to strongly encourage state Medicaid agencies to proactively review providers selected for the state's PERM review; determine whether any of the selected providers are subjects of current or impending fraud investigations; and assess whether a PERM review could compromise the fraud investigation. CMS included this clarification in updated contractor guidance and in information provided to state Medicaid agencies. CMS plans to include the updated guidance in the fiscal year 2019 PERM program manual, which CMS anticipates completing by the end of 2019. Such revisions to the PERM manual will further codify and encourage state efforts to prevent PERM reviews from potentially compromising ongoing fraud investigations. As of September 2020, CMS has not informed us of any additional actions taken to implement this recommendation, including of any revisions to the PERM manual; we will update the status of this recommendation when we receive additional information.

Recommendation: The Administrator of CMS should address disincentives for state Medicaid agencies to notify the PERM contractor of providers under fraud investigation. This could include educating state officials about the benefits of reporting providers under fraud investigation, and taking actions such as revising how claims from providers under fraud investigation are accounted for in state-specific FFS improper payment rates, or the need for corrective actions in such cases. (Recommendation 4)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: The Department of Health and Human Services (HHS) concurred with this recommendation. In October 2019, the Centers for Medicare & Medicaid Services (CMS) noted that the agency updated Medicaid Payment Error Rate Measurement (PERM) guidance regarding state Medicaid agencies' corrective action plans for providers under fraud investigation. If a state Medicaid agency opts to remove a provider from the state's PERM review due to a fraud investigation, claims associated with the provider are determined to be improper, due to no documentation. Under the updated guidance, states are no longer required to develop a corrective action plan for such claims, since the state is already addressing the issue through a fraud investigation. CMS included this updated guidance in the fiscal year 2017 PERM corrective action plan template, and plans to include the updated guidance in the fiscal year 2019 PERM program manual, which CMS anticipates completing by the end of 2019. Such revisions to the PERM manual will remove a disincentive for state Medicaid agencies to notify the PERM contractor of providers under fraud investigation. As of September 2020, CMS has not informed us of any additional actions taken to implement this recommendation, including of any revisions to the PERM manual; we will update the status of this recommendation when we receive additional information.

Recommendation: As VA and IHS revise the MOU and related performance measures, the Secretary of Veterans Affairs should ensure these measures are consistent with the key attributes of successful performance measures, including having measurable targets. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Veterans Affairs should, in consultation with IHS and tribes, establish and distribute a written policy or guidance on how referrals from IHS and Tribal Health Program (THP) facilities to VA facilities for specialty care can be managed. (Recommendation 2)

Agency: Department of Veterans Affairs
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: As VA and IHS revise the MOU and related performance measures, the Director of IHS should ensure these measures are consistent with the key attributes of successful performance measures, including having measurable targets. (Recommendation 3)

Agency: Department of Health and Human Services: Public Health Service: Indian Health Service
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Under Secretary for Health should ensure that facility officials who are responsible for credentialing, reviewing credentials, and hiring receive periodic mandatory training. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open

Comments: As of March 2020, VA officials told us that they expect to have this recommendation implemented during calendar year 2020.

Recommendation: The Under Secretary for Health should develop policies and guidance regarding DEA registrations, including the circumstances in which Drug Enforcement Administration (DEA) waivers may be required, the process for requesting them, and a mechanism to ensure that facilities follow these policies. (Recommendation 2)

Agency: Department of Veterans Affairs
Status: Open
Priority recommendation

Comments: As of March 2020, this recommendation remains open. VA sent a letter to DEA asking for clarification about DEA employment waivers and received a response from DEA dated November 26, 2019. VA officials told us that they are considering the input from DEA and consulting with relevant stakeholders to determine next steps. To fully implement this recommendation, VA needs to provide evidence of actions taken to ensure that DEA requirements regarding DEA registrations and employment waivers are met. Such actions include developing policies regarding when a DEA employment waiver may be necessary and guidance about how to request such a waiver.

Recommendation: The Under Secretary for Health should identify and review providers whose DEA registrations were revoked or surrendered for cause and determine whether an employment waiver may be needed from DEA. (Recommendation 3)

Agency: Department of Veterans Affairs
Status: Open
Priority recommendation

Comments: As of March 2020, VA has reported important steps toward implementing this recommendation. Specifically, VA officials told us that they reviewed licensed independent practitioners to see if any that are currently employed at VA have a revoked or surrendered DEA registration. They identified at least one provider with a revoked or surrendered DEA registration. To fully implement this recommendation, VA needs to provide evidence that appropriate action was taken for this provider, such as obtaining a DEA waiver if necessary.

Recommendation: The Secretary of Defense should ensure that the Under Secretary of Defense for Personnel and Readiness, in coordination with the Director, CAPE, the Joint Staff Surgeon, and the secretaries of the military departments, establish joint planning assumptions for developing operational medical and dental personnel requirements, including a definition of what forces should and should not be identified as "operational." (Recommendation 1)

Agency: Department of Defense
Status: Open

Comments: The Department of Defense concurred with this recommendation and said it would take steps to implement it. According to department officials, as of November 2019, they are drafting a report that will address this recommendation. We will continue to monitor DOD's efforts.

Recommendation: The Secretary of Defense should ensure that the Under Secretary of Defense for Personnel and Readiness, in coordination with the Director of Cost Assessment and Program Evaluation, the Joint Staff Surgeon, and the secretaries of the military departments, establish a method to assess options for achieving joint efficiencies in medical and dental personnel requirements and any associated risks. (Recommendation 2)

Agency: Department of Defense
Status: Open

Comments: The Department of Defense concurred with this recommendation and said it would take steps to implement it. According to department officials, as of November 2019, they are drafting a report that will address this recommendation. We will continue to monitor the department's efforts. .

Recommendation: The Secretary of Defense should ensure that the Under Secretary of Defense for Personnel and Readiness, in coordination with the Director of Cost Assessment and Program Evaluation, the Joint Staff Surgeon, and the secretaries of the military departments, apply joint planning assumptions and a method for assessing efficiencies and risk, use these to determine operational medical and dental requirements, and report to Congress. (Recommendation 3)

Agency: Department of Defense
Status: Open

Comments: The Department of Defense concurred with this recommendation and said it would take steps to implement it. According to department officials, as of November 2019, they are drafting a report that will address this recommendation. We will continue to monitor DOD's efforts..

Recommendation: The Secretary of Defense should ensure that the Assistant Secretary of Defense for Health Affairs, in coordination with the Surgeons General of the military departments, identify and mitigate limitations in the clinical readiness metric, such as data reliability, a lack of complete information on reserve component providers and patient care workload performed outside of medical treatment facilities (MTFs), and the lack of linkage between the metric and patient care and retention outcomes. (Recommendation 4)

Agency: Department of Defense
Status: Open

Comments: The Department of Defense concurred with this recommendation and said it would take steps to implement it. As of November 2019, DOD has not taken any actions to implement this recommendation.

Recommendation: The Secretary of Defense should ensure that the Assistant Secretary of Defense for Health Affairs, in coordination with the Surgeons General of the military departments and the Director of the Defense Health Agency, determines which critical wartime specialties perform high-risk, high-acuity procedures and rely upon perishable skill sets and use this information to prioritize specialties to which the clinical readiness metric could be expanded (Recommendation 5).

Agency: Department of Defense
Status: Open

Comments: The Department of Defense concurred with this recommendation and said it would take steps to implement it. As of November 2019, DOD has not implemented this recommendation.

Recommendation: The Secretary of Defense should ensure that the Assistant Secretary of Defense for Health Affairs, in coordination with each of the Surgeons General of the military departments and the Director of the Defense Health Agency, estimates the cost and benefits, by specialty, of implementing a clinical readiness metric and use that information to determine whether DODs approach should be revised. Costs to be considered should include those needed to provide additional training for medical personnel to achieve clinical readiness thresholds and to hire additional civilian personnel in MTFs to backfill military providers who leave to attend training. (Recommendation 6)

Agency: Department of Defense
Status: Open

Comments: The Department of Defense concurred with this recommendation and said it would take steps to implement it. As of November 2019, DOD has not implemented this recommendation.

Recommendation: CMS should take action to ensure South Dakota's Medicaid state plan provides coverage for abortions in cases of rape and in cases of incest, in addition to life endangerment, to comply with federal law, which currently requires such coverage. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: In June 2019, HHS officials reported they were reviewing agency processes and would determine the best course of action moving forward. Officials said they would provide an update on actions by 12/20/2019. As of April 6, 2020, this recommendation remains open.

Recommendation: CMS should determine the extent to which state Medicaid programs are in compliance with federal requirements regarding coverage of Mifeprex and take actions to ensure compliance, as appropriate. (Recommendation 2)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: In June 2019, HHS officials reported they were reviewing agency processes and would determine the best course of action moving forward. Officials said they would provide an update on actions by 12/20/2019. As of April 6, 2020, this recommendation remains open.

Recommendation: CMS should determine the extent to which state Medicaid programs are accurately reporting fee-for-service abortions on line 14 of the CMS-64 and take actions to ensure accuracy, as appropriate. (Recommendation 3)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: In June 2019, HHS officials reported they were developing written instructions for states to reiterate fee-for-service reporting requirements for abortions provided in their Medicaid programs. Officials said they would provide an update on actions by 12/20/2019. As of April 6, 2020, this recommendation remains open.

Recommendation: The Administrator of CMS should take steps to collect all of the data from all laboratories that are required to report. If only partial data can be collected, CMS should estimate how incomplete data would affect Medicare payment rates and address any significant challenges to setting accurate Medicare rates. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of CMS should phase in payment-rate reductions that start from the actual payment rates Medicare paid prior to 2018 rather than the national limitation amounts. CMS should revise these rates as soon as practicable to prevent paying more than necessary. (Recommendation 2)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of CMS should use bundled rates for panel tests, consistent with its practice prior to 2018, rather than paying for them individually; if necessary, the Administrator of CMS should seek legislative authority to do so. (Recommendation 3)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Defense should ensure that the Assistant Secretary of Defense for Health Affairs, in coordination with the military departments, perform an assessment of the suitability of federal civilian and contractor personnel to provide operational medical care and incorporate the results of the assessment into relevant policies, if warranted. (Recommendation 1)

Agency: Department of Defense
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Defense should ensure that the Under Secretary of Defense for Personnel and Readiness require consideration of cost when making determinations regarding the mix of active and reserve component medical personnel. (Recommendation 2)

Agency: Department of Defense
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Defense should ensure that the Assistant Secretary of Defense for Health Affairs, in collaboration with the Director of Cost Assessment and Program Evaluation and the military departments, develop full cost information for active and reserve component medical personnel, and the military departments use that information in its determinations regarding the mix of active and reserve component medical personnel. (Recommendation 3)

Agency: Department of Defense
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Defense should ensure that the Director of the Defense Health Agency develop a strategic total workforce plan which includes, among other things: (1) tailored human capital strategies, tools, and metrics by which to monitor and evaluate progress toward reducing personnel gaps, and; (2) integration of human capital strategies with acquisition plans, such as DOD's acquisition strategy for health care services at DOD's military treatment facilities. (Recommendation 4)

Agency: Department of Defense
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Defense and the Secretaries of the Army, the Navy, and the Air Force, respectively, should ensure that accompanying the transfer of administrative responsibility for military treatment facilities to the Defense Health Agency, that the Defense Health Agency and the military departments develop policies and procedures for management of military personnel, including agreement on specific roles and responsibilities for the military departments and the Defense Health Agency in this process. (Recommendation 5)

Agency: Department of Defense
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of Defense should ensure that the Assistant Secretary of Defense for Health Affairs, in coordination with Director of the DHA and the Surgeons General of the military departments, define and analyze the 16 operational readiness and installation-specific medical functions currently excluded from transfer to the DHA to determine whether opportunities exist to reduce or better manage duplicative functions and improve efficiencies in the administration of the MTFs. (Recommendation 1)

Agency: Department of Defense
Status: Open
Priority recommendation

Comments: DOD concurred with this recommendation. According to responses provided by DOD officials in December 2019, the department provided guidance on the division of the 16 operational readiness and installation-specific medical functions in a March 2019 memorandum from the Office of the Under Secretary of Defense for Personnel and Readiness. However, further detail is needed regarding what analysis DOD completed to assess the 16 functions for duplication.

Recommendation: The Secretary of Defense should ensure that the Assistant Secretary of Defense for Health Affairs, in coordination with DHA Assistant Director for Health Care Administration and the Secretaries of the military departments, validate headquarters-level personnel requirements to determine that they are established at the minimum levels necessary--per DOD guidance--to accomplish missions and achieve objectives before transferring authority, direction, and control of the MTFs to the DHA for the third phase. (Recommendation 2)

Agency: Department of Defense
Status: Open
Priority recommendation

Comments: DOD concurred with this recommendation. In December 2019, DOD officials stated that DOD conducted a review of the DHA personnel requirements and that the military departments also conducted reviews. DOD officials also stated that DOD will continue to evaluate the mix of contractors, military, and civilian employees during and after the transition. However, the review of DHA personnel requirements DOD officials referenced in their December 2019 responses, as GAO previously reported in GAO-19-53, did not validate personnel requirements. Further information is needed regarding what steps DOD is taking to validate headquarters-level personnel requirements.

Recommendation: The Secretary of Defense should ensure that the Assistant Secretary of Defense for Health Affairs, in coordination with DHA Assistant Director for Health Care Administration and the Secretaries of the military departments, conduct a comprehensive review to identify the least costly mix--per DOD guidance--of military, civilian, and contractors needed to meet validated requirements--that is, to perform the functions identified at the DHA headquarters and intermediate management organizations and at the military departments' headquarters and intermediate commands. Additionally, this comprehensive review should be completed before transferring authority, direction, and control of the MTFs to the DHA for the third phase. (Recommendation 3)

Agency: Department of Defense
Status: Open
Priority recommendation

Comments: DOD concurred with this recommendation. In December 2019, DOD officials stated that through the review of the budget development process, DOD transferred 1,900 personnel to the military departments for the management of their respective readiness missions. Further, DOD officials mentioned a 2018 report concerning a review of DHA personnel requirements. As reported in GAO-19-53, the report on DHA personnel requirements was specific to DHA and did not include information regarding the military departments' headquarters and intermediate commands. Further information is needed to determine whether DOD's efforts included a comprehensive review that considers the least costly mix--per DOD guidance--of military, civilian, and contractor personnel.

Recommendation: The Administrator of CMS should provide states with more information on how to fulfill the requirement for independent encounter data audits, including information on the required audit scope and methodology, and what should be described in the resulting report. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS agreed with our recommendation, noting that CMS would provide states with additional information on how to fulfill the requirement for independent encounter data audits. HHS also noted in January 2019 that CMS was developing voluntary guidance that will include information on best practices for validating encounter data. To implement this recommendation, the Administrator of CMS should inform states of the required audit scope and methodology as well as the resulting report. As of January 2020, HHS officials have not informed us of any additional actions taken to implement this recommendation. We will update the status of this recommendation when we receive additional information.

Recommendation: The Administrator of CMS should provide states information on the required content of the annual assessment of encounter data reporting. (Recommendation 2)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS agreed with our recommendation, noting that CMS would provide states further information on the required content of the annual assessment. In January 2019, HHS noted that CMS continues to develop guidance to states on how to fulfill the annual assessment requirement. As of January 2020, HHS officials have not informed us of any additional actions taken to implement this recommendation. We will update the status of this recommendation when we receive additional information.

Recommendation: The Administrator of CMS should provide states with information on the circumstances under which CMS would defer or disallow matching funds in response to noncompliant encounter data submissions. (Recommendation 3)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS neither agreed nor disagreed with our recommendation and noted steps it has already taken to remind states of their obligation to submit timely, quality encounter data, and prioritize data quality. In January 2019, HHS identified a possible step CMS could take in the event it finds deficiencies in states' encounter data reporting that cannot be resolved through informal monitoring and discussions with state Medicaid agencies. In particular, HHS noted that CMS would issue guidance on the parameters by which the agency would impose financial penalties on states for noncompliant encounter data submissions, if necessary. In February 2020, CMS officials told us that they continue to monitor state encounter data submissions and would issue guidance to states if they identify deficiencies in the data that cannot be resolved through informal monitoring and disccussions with state Medicaid agencies. To implement this recommendation, the Administrator of CMS should provide states with this information. We will update the status of this recommendation when we receive additional information.

Recommendation: The Secretary of the VA should direct the Undersecretary for Health to designate a focal point for overseeing VAMCs' pharmacy inventory management system-wide and define the focal point's responsibilities. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open

Comments: VA officials provided documentation showing approval as of September 2019 for the procurement of a perpetual inventory management system that would allow VA medical facilities to keep track of inventory for all prescription drugs and assist VA with system-wide oversight. As of January 2020, this contract has yet to be awarded. In January 2020, VA officials also stated that Pharmacy Benefits Management (PBM) Services has been designated as the focal point for overseeing VA medical facilities' inventory management system-wide. VA officials stated that PBM is responsible for developing VA medical facility inventory management policy; however, VA did not provide documentation on PBM's defined responsibilities for system-wide oversight in the absence of an inventory system and once the system is procured. We plan to keep this recommendation open until we receive documentation of PBM's defined responsibilities for overseeing VAMC's pharmacy inventory management system-wide.

Recommendation: As MHS governing bodies conduct their recurring reviews of quality measures selected for MHS's Core Dashboard and Purchased Care Dashboards, the Assistant Secretary of Defense for Health Affairs should direct those bodies to prioritize, as appropriate, the selection of measures that apply to both direct and purchased care at the provider level and that expand the range of quality measure types and medical conditions that are assessed. (Recommendation 1)

Agency: Department of Defense: Office of the Assistant Secretary of Defense (Health Affairs)
Status: Open

Comments: As of January 2020, DOD officials described proposed actions to address key elements of our recommendation. Specifically, DOD officials described compiling a comprehensive library of existing inpatient and outpatient quality measures for both direct and purchased care; categorizing those measures by type and medical condition; and identifying 8 measures that are common across direct and purchased care. DOD stated it is considering expanding those 8 common measures to 12 measures. The new measures would cover three cancer screening measures and an additional inpatient satisfaction measure. However, DOD officials noted these 12 measures are not reported at the provider level for purchased care given current contract reporting requirements and would require contract modifications. DOD officials also said they are participating in an interagency partnership to use a common set of quality measures across federal programs, including under the Department of Veterans Affairs. Once those quality measures are determined, DOD may expand the range of quality measures common across direct and purchased care to be consistent with other federal programs. We will keep this recommendation open until DOD provides additional information on actions taken to select and expand quality measures across direct and purchased care.

Recommendation: The Assistant Secretary of Defense for Health Affairs should establish, as appropriate, performance standards related to the Purchased Care Dashboard measures that are consistent with the MHS's performance standards for direct care; ensure they are applied to individual purchased care providers; and take steps, such as amending its managed care support contracts, if necessary, to require corrective actions to be taken when providers do not meet those standards. (Recommendation 2)

Agency: Department of Defense: Office of the Assistant Secretary of Defense (Health Affairs)
Status: Open

Comments: As of January 2020, DOD officials said that once a common set of quality measures is adopted to the extent possible across direct and purchased care (as discussed in Recommendation 1), DOD plans to establish consistent performance standards applied to individual providers and plans to develop processes to issue corrective actions for individual direct and purchased care providers who do not consistently meet established standards. We will update this recommendation as DOD provides progress updates on the implementation of these plans.

Recommendation: The Secretary of Veterans Affairs should ensure that the role and responsibilities of the Interagency Program Office are clearly defined within the governance plans for acquisition of the department's new electronic health record system. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open
Priority recommendation

Comments: The Department of Veterans Affairs (VA) concurred with our recommendation to ensure that the role and responsibilities of the Interagency Program Office (IPO) were clearly defined within the governance plans for acquisition of the department's new electronic health record system. As of December 2019, VA and the Department of Defense (DOD) have replaced the IPO with a new joint governance body. Specifically, the Federal Electronic Health Record Modernization (FEHRM) program office has been established to serve as the single point of accountability in the delivery of a common health record between the departments and the advancement of interoperability with the private sector. In its charter, the FEHRM was described as a single decision-making authority to manage issues in support of the departments' integrated electronic health record objectives and its leadership is responsible for, among other things, working to formulate, oversee, de-conflict, and ensure adherence to electronic health record-related VA and DOD policies. However, the corresponding Implementation Plan that is intended to document how the FEHRM executes its full responsibilities has yet to be issued. To fully implement this recommendation, VA needs to document the role and responsibilities of the FEHRM with respect to VA's acquisition of its new electronic health record system, explaining the role, if any, the FEHRM will have in the governance process. We will continue to monitor the departments' incorporation of the FEHRM into the plans for the ongoing acquisition.

Recommendation: Congress should consider passing legislation to put postal retiree health benefits on a more sustainable financial footing.

Agency: Congress
Status: Open

Comments: As of March 2020, Congress has taken no action on this matter.

Recommendation: The Director of IHS should obtain, on an agency-wide basis, information on temporary provider contractors, including their associated cost and number of full-time equivalents, and use this information to inform decisions about resource allocation and provider staffing. (Recommendation 1)

Agency: Indian Health Service
Status: Open

Comments: In February 2020, IHS reported that challenges in rolling-up contractor information on a national level stem from the fact that the agency often uses single contract vehicles, such as staffing companies, to hire multiple providers for temporary periods of time. IHS's contract databases do not centrally track the numbers of individual providers through such staffing contracts. The ability to analyze and compare detailed actual costs of federal hires vs. contract hires is currently limited to local information sources and on a narrow area of focus, such as one provider category or one facility at a time. IHS reported that the agency is implementing a monthly reporting requirement for IHS Areas and plans to use this information to inform decisions about resource allocation and provider staffing. We will review these reporting requirements when they have been fully implemented.

Recommendation: The Administrator of CMS should complete a comprehensive, national risk assessment and take steps, as needed, to assure that resources to oversee expenditures reported by states are adequate and allocated based on areas of highest risk. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open
Priority recommendation

Comments: CMS has taken steps to conduct a comprehensive national risk assessment. As of October 2019, CMS had developed a standard tool to assess risk and staff capacity. The agency indicated that once the assessment is complete, CMS will identify opportunities to increase resources, review the current allocation of financial staff, and determine the appropriate allocation of staff by state. We will continue to monitor CMS's action to complete this assessment.

Recommendation: The Administrator of CMS should clarify in internal guidance when a variance analysis on expenditures with higher match rates is required. (Recommendation 2)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: In October 2019, CMS indicated that the agency held meetings to clarify internal guidance on the variance analysis and is the process of drafting updated guidance for the CMS-64 review. We will continue to monitor CMS's actions to update the guidance.

Recommendation: The Administrator of CMS should revise the sampling methodology for reviewing expenditures for the Medicaid expansion population to better target reviews to areas of high risk. (Recommendation 3)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: In October 2019, CMS indicated that given their current resources, they believe the sampling methodology is sufficient and have no plans to revise it. The agency noted that the current methodology requires a minimum sample size but gives reviewers the flexibility to expand the size of the sample if warranted by risk and as resources permit. We continue to believe that the current methodology does not sufficiently target areas of high risk.

Recommendation: The Under Secretary of Health should ensure all RME inspections are being conducted and reported as required and that the inspection results VHA has are complete. (Recommendation 1)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open

Comments: VA agreed with this recommendation and indicated it would establish an oversight process for reviewing and monitoring findings from inspections. VA has described some of the oversight actions it has put in place and noted that actions would be completed in 2020. We will update the status of this recommendation when additional information is received.

Recommendation: The Under Secretary of Health should examine the Sterile Processing Services workforce needs and take action based on this assessment, as appropriate. (Recommendation 3)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open

Comments: VA agreed with this recommendation and indicated it would review workforce needs and take necessary actions. VA has described some of the actions taken and noted that actions would be completed in 2019. We will update the status of this recommendation when additional information is received.

Recommendation: The Administrator of CMS should eliminate impediments to collaborative audits in managed care conducted by audit contractors and states, by ensuring that managed care audits are conducted regardless of which entity--the state or the managed care organization--recoups any identified overpayments. (Recommendation 2)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open
Priority recommendation

Comments: CMS agreed with and has taken some steps to address this action, as recommended by GAO in July 2018. In September 2019, CMS reported that in July 2019 CMS held a meeting with states and collaborative audit contractors to discuss coordination of managed care audits, including a wide range of challenges with managed care audits. As result of the feedback and recommendations received, CMS is evaluating several process improvements and reiterated that audit contractors will continue to work with states to provide support and assistance in Medicaid managed care, and that Medicaid managed care audits should not be limited by MCO contract language. Although CMS has communicated to states the need to increase audits in managed care and address identified issues, it is unclear if these actions will remove known impediments to managed care audits or result in an increase in the number of collaborative audits. Implementing GAO's July 2018 recommendation is needed because few audits of Medicaid managed care have been conducted and overpayments can be significant based on the findings from federal and state audits and investigations that have been completed. .

Recommendation: The Secretary of HHS should establish numeric enrollment targets for healthcare.gov, to ensure it can monitor its performance with respect to its objectives. (Recommendation 2)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS does not concur with this recommendation. In October 2018, the agency noted that there are numerous external factors, such as the state of the economy and plan premiums, that may affect the number of people who decide to enroll in coverage. HHS also stated that it does not believe that numeric enrollment targets are relevant to assess the performance of objectives related to a successful open enrollment period. We continue to believe that the development of numeric enrollment targets is important for effective monitoring of the program and management of its resources. As of September 2019, HHS had not provided any additional information about steps to implement this recommendation. The status of this recommendation will be reconsidered once relevant action is taken.

Recommendation: Should the agency continue to focus on enhancing the consumer experience as a goal for the program, the Secretary of HHS should assess other aspects of the consumer experience, such as those it previously identified as key, to ensure it has quality information to achieve its goal. (Recommendation 3)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS concurs with this recommendation, and in October 2018, stated that as it is looking for ways to improve the consumer experience, it will consider focusing its assessment on other aspects of the consumer experience as needed. As of September 2019, HHS had not provided evidence of any additional steps it had taken to improve the consumer experience. The status of this recommendation will be reconsidered once relevant action is taken.

Recommendation: The Administrator of HRSA should require covered entities to register contract pharmacies for each site of the entity for which a contract exists. (Recommendation 1)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS does not concur with this recommendation and, as of July 2020, did not plan to take any actions to implement the recommendation. As noted in our report, without complete information on contract pharmacy arrangements--including information on with sites of a covered entity have contracts with a contract pharmacy--HRSA cannot ensure that it is optimally targeting the limited number of audits done each year. Additionally, manufacturers lack important information to help ensure that 340B discounted drugs are only provided to pharmacies with a valid 340B contract with the covered entity site for which the drug is being dispensed.

Recommendation: The Administrator of HRSA should issue guidance to covered entities on the prevention of duplicate discounts under Medicaid managed care, working with CMS as HRSA deems necessary to coordinate with guidance provided to state Medicaid programs.(Recommendation 2)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open
Priority recommendation

Comments: HHS concurred with this recommendation. In July 2020, HHS indicated that it believes that guidance does not provide HRSA appropriate enforcement capability and that this recommendation can only be accomplished after policy is issued. HRSA has requested regulatory authority for all aspects of the 340B Program in the FY 2021 President's Budget.

Recommendation: The Administrator of HRSA should incorporate an assessment of covered entities' compliance with the prohibition on duplicate discounts, as it relates to Medicaid managed care claims, into its audit process after guidance has been issued and ensure that identified violations are rectified by the entities. (Recommendation 3)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open
Priority recommendation

Comments: HHS concurred with this recommendation. In July 2020, HHS indicated that it believes that guidance does not provide HRSA appropriate enforcement capability and that this recommendation can only be accomplished after policy is issued. HRSA has requested regulatory authority for all aspects of the 340B Program in the FY 2021 President's Budget.

Recommendation: The Administrator of HRSA should issue guidance on the length of time covered entities must look back following an audit to identify the full scope of noncompliance identified during the audit.(Recommendation 4)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS concurred with this recommendation. In July 2020, HHS indicated that it believes that guidance does not provide HRSA appropriate enforcement capability and that this recommendation can only be accomplished after policy is issued. HRSA has requested regulatory authority for all aspects of the 340B Program in the FY 2021 President's Budget.

Recommendation: The Administrator of HRSA should require all covered entities to specify their methodology for identifying the full scope of noncompliance identified during the audit as part of their corrective action plans, and incorporate reviews of the methodology into their audit process to ensure that entities are adequately assessing the full scope of noncompliance. (Recommendation 5)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS does not concur with this recommendation and, as of July 2020, did not plan to take any actions to implement the recommendation. HHS noted that requiring all covered entities subject to an audit to specify their methodology for identifying the full scope of noncompliance identified during the audit would create a significant burden for covered entities. However, as noted in our report, HRSA already requires covered entities with audit findings to determine the full scope of noncompliance and requires entities subject to a targeted audit to provide their methodology for such assessments to HRSA. Thus, it is unclear how requiring covered entities subject to risk-based, as opposed to targeted, audits to provide HRSA with a written description of methodologies that they are already required to formulate and implement would create a significant additional burden. Without this information, HRSA does not have reasonable assurance that the majority of covered entities have adequately identified all instances of noncompliance.

Recommendation: The Administrator of HRSA should require all covered entities to provide evidence that their corrective action plans have been successfully implemented prior to closing audits, including documentation of the results of the entities' assessments of the full scope of noncompliance identified during each audit.(Recommendation 6)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS does not concur with this recommendation and, as of July 2020, did not plan to take any actions to implement the recommendation. HHS stated that requiring all covered entities with audit findings to provide evidence that their corrective action plans have been successfully implemented would create an undue burden for covered entities. However, HRSA already requires such evidence from covered entities subject to targeted audits, and it is unclear how providing evidence of implementation of corrective actions that entities developed and are required to implement would create significant additional burden for these entities. Additionally, without such evidence HRSA does not have a reasonable assurance that the majority of covered entities audited have corrected the issues identified in the audit, and are not continuing practices that could lead to noncompliance.

Recommendation: The Administrator of HRSA should provide more specific guidance to covered entities regarding contract pharmacy oversight, including the scope and frequency of such oversight. (Recommendation 7)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS concurred with this recommendation. In July 2020, HHS indicated that it believes that guidance does not provide HRSA appropriate enforcement capability and that this recommendation can only be accomplished after policy is issued. HRSA has requested regulatory authority for all aspects of the 340B Program in the FY 2021 President's Budget.

Recommendation: The Under Secretary for Health should establish an achievable wait-time goal for the consolidated community care program that VA plans to implement that will permit VHA to monitor whether veterans are receiving VA community care within time frames that are comparable to the amount of time they would otherwise wait to receive care at VHA medical facilities. (Recommendation 1)

Agency: Department of Veterans Affairs: Office of the Under Secretary for Health
Status: Open
Priority recommendation

Comments: The Veterans Health Administration (VHA) agreed with our recommendation and stated in March 2020 that it is taking steps to establish a wait-time goal for the new consolidated community care program-the Veterans Community Care Program. Actions include updating VHA's current directives and the implementation of the HealthShare Referral Manager, a software system that will provide VHA the capability to monitor wait times.

Recommendation: The Under Secretary for Health should design an appointment scheduling process for the consolidated community care program that VA plans to implement that sets forth time frames within which (1) veterans' referrals must be processed, (2) veterans' appointments must be scheduled, and (3) veterans' appointments must occur, which are consistent with the wait-time goal VHA has established for the program. (Recommendation 2)

Agency: Department of Veterans Affairs: Office of the Under Secretary for Health
Status: Open
Priority recommendation

Comments: The Veterans Health Administration (VHA) agreed with our recommendation and stated in March 2020 that it is taking steps to design an appointment scheduling process for the new consolidated community care program-the Veterans Community Care Program. This includes actions to develop a wait-time goal, and the development and review of VHA's new community care directive.

Recommendation: The Under Secretary for Health should establish a mechanism that will allow VHA to systematically monitor the average number of days it takes for VAMCs to prepare referrals, for VAMCs or TPAs to schedule veterans' appointments, and for veterans' appointments to occur, under the consolidated community care program that VA plans to implement. (Recommendation 3)

Agency: Department of Veterans Affairs: Office of the Under Secretary for Health
Status: Open

Comments: The Veterans Health Administration (VHA) agreed with our recommendation and stated in March 2020 that it is taking steps to establish a mechanism to monitor appointment timeliness for the new consolidated community care program-the Veterans Community Care Program. This includes the implementation of the HealthShare Referral Manager, a software system that will allow VHA to measure timeliness of appointment scheduling actions, development of a wait-time goal, review of current VHA directives, and the development of reports that can be used by VA medical centers to monitor appointment scheduling timeliness.

Recommendation: The Under Secretary for Health should implement a mechanism to prevent veterans' clinically indicated dates from being modified by individuals other than VHA clinicians when veterans are referred to the consolidated community care program that VA plans to implement. (Recommendation 4)

Agency: Department of Veterans Affairs: Office of the Under Secretary for Health
Status: Open

Comments: The Veterans Health Administration (VHA) agreed with our recommendation and stated that it is taking steps to implement a mechanism to prevent veterans' clinically indicated dates (CID) from being modified by VHA staff other than VHA providers for the new consolidated community care program-the Veterans Community Care Program. Specifically, VHA developed the HealthShare Referral Manager (HSRM), a software system for VA medical center (VAMC) staff to use to manage VCCP referrals, including creating authorizations and scheduling veteran appointments with community providers. VHA deployed the HSRM at all VAMCs as of June 24, 2019, and according to VHA officials, the system was fully implemented as of December 31, 2019. In March 2020, VHA provided documentation that shows (1) the VHA clinician populates the CID field when they create the referral in VA's electronic medical record system, (2) when the referral is forwarded to HSRM for referral management and appointment scheduling by VAMC staff, the CID field in HSRM is auto-populated based on the CID in VA's electronic medical record system, and (3) the auto-populated CID field in HSRM cannot be edited. However, under VA's current scheduling process, some VHA staff can still edit the referral after the VHA provider enters the CID and before it is sent to the HSRM for scheduling. VHA will need to take action to ensure this part of the process has protections to ensure veterans' CIDs aren't modified after being entered by the VHA provider.

Recommendation: The Under Secretary for Health should implement a mechanism to separate clinically urgent referrals and authorizations from those for which the VAMC or the TPA has decided to expedite appointment scheduling for administrative reasons. (Recommendation 5)

Agency: Department of Veterans Affairs: Office of the Under Secretary for Health
Status: Open

Comments: The Veterans Health Administration (VHA) did not concur with this recommendation, and states a mechanism is no longer needed as VA medical center staff are responsible for appointment scheduling under the new consolidated community care program, the Veterans Community Care Program (VCCP), not staff from third-party administrators. However, we believe this recommendation is still relevant, and in July 2020 we asked VHA for evidence to show that VA medical center staff, when scheduling VCCP appointments, are not changing routine referrals to an urgent status to expedite appointment scheduling in cases of delays.

Recommendation: The Under Secretary for Health should (1) establish oversight mechanisms to ensure that VHA is collecting reliable data on the reasons that VAMC or TPA staff are unsuccessful in scheduling veterans' appointments through the consolidated community care program VA plans to implement, and (2) demonstrate that it has corrected any identified deficiencies. (Recommendation 6)

Agency: Department of Veterans Affairs: Office of the Under Secretary for Health
Status: Open

Comments: The Veterans Health Administration (VHA) agreed with our recommendation and stated in March 2020 that it is taking steps to establish an oversight mechanism to ensure VHA is collecting reliable data in cases where staff are unsuccessful in scheduling veterans' appointments for the new consolidated community care program-the Veterans Community Care Program. This includes actions to implement the HealthShare Referral Manager, a software system that will allow VHA to produce reports on reasons for unsuccessful scheduling attempts, development of a community care directive, and an analysis of the reasons behind unsuccessful scheduling.

Recommendation: The Secretary of Veterans Affairs should ensure that the contracts for the consolidated community care program VA plans to implement include performance metrics that will allow VHA to monitor average driving times between veterans' homes and the practice locations of community providers that participate in the TPAs' networks. (Recommendation 7)

Agency: Department of Veterans Affairs
Status: Open

Comments: The Veterans Health Administration agreed with this recommendation, and as of March 2020, reported that it included performance metrics related to drive times in its contracts for the new third-party administrators in Regions 1-4 of the new Community Care Network under the Veterans Community Care Program. The contracts for Regions 5 and 6 have not been awarded yet.

Recommendation: The Under Secretary for Health should issue a comprehensive policy directive and operations manual for the consolidated community care program VA plans to implement and ensure that these documents are reviewed and updated in a timely manner after any significant changes to the program occur. (Recommendation 10)

Agency: Department of Veterans Affairs: Office of the Under Secretary for Health
Status: Open

Comments: The Veterans Health Administration agreed in principle with this recommendation, and stated that it has taken action to develop a new community care directive, which was under technical review as of March 2020.

Recommendation: The Administrator of APHIS should develop a timeline for (1) defining birds that are not bred for research and that are covered by the Animal Welfare Act, and (2) requiring that research facilities report to APHIS their use of birds covered by the act. (Recommendation 1)

Agency: Department of Agriculture: Animal and Plant Health Inspection Service
Status: Open

Comments: According to APHIS officials, the agency developed a timeline and a work plan for an Advance Notice of Proposed Rule Making (ANPRM) to define "bred for use in research" as it applies to birds (as well as to rats and mice) under the Animal Welfare Act and submitted it to USDA officials on July 18, 2019. However, as of October 2019, USDA had not established a date to publish the ANPRM and had instead placed it on the department's long-term regulatory agenda. We will continue to monitor USDA's efforts and provide updated information when it becomes available.

Recommendation: The Administrator of APHIS should instruct federal agencies to report their use of animals covered by the Animal Welfare Act in federal facilities located outside of the United States. (Recommendation 2)

Agency: Department of Agriculture: Animal and Plant Health Inspection Service
Status: Open

Comments: USDA disagreed with this recommendation for several reasons. For example, USDA stated that the absence of an exclusion to the requirements of the Animal Welfare Act or its regulations for federal research located outside of the United States does not create a requirement to collect information about such facilities' use of animals. In October 2019, APHIS officials said the agency continues to disagree with the recommendation. However, we have no reason to believe that such facilities should be excluded under the Act, and we continue to believe that the Administrator of APHIS should instruct federal agencies to report their use of animals in activities covered by the Animal Welfare Act in federal facilities located outside of the United States. We will continue to monitor any actions taken by APHIS to address this recommendation and provide updated information when it becomes available.

Recommendation: In developing the definition of field studies, the Administrator of APHIS should provide research facilities with clear criteria for identifying field studies that are covered by the Animal Welfare Act's regulations and that facilities should report to APHIS as well as field studies that facilities should not report. (Recommendation 3)

Agency: Department of Agriculture: Animal and Plant Health Inspection Service
Status: Open

Comments: In its comments on our draft report, USDA stated that APHIS agreed to issue a guidance document by December 31, 2018. According to APHIS officials, the agency prepared a draft guidance document entitled "Research Involving Free-Living Wild Species" for departmental review in April 2019. As of October 2019, APHIS was in the process of reviewing comments from the department. We will continue to monitor APHIS and USDA's actions to implement the recommendation.

Recommendation: The Undersecretary for Health should ensure that Central Office, Veterans Integrated Service Networks (VISN), and medical facilities document the actions they take towards achieving OSI goals. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open

Comments: VA concurred with the recommendation. To fully implement this recommendation, VHA needs to provide information about the new documentation requirements described in the November 2019 update.

Recommendation: The Undersecretary for Health should ensure that any OSI goals that have not been met have clearly defined, measurable outcomes, including milestones or numerical targets, as appropriate, and timeframes. (Recommendation 2)

Agency: Department of Veterans Affairs
Status: Open

Comments: VA concurred with the recommendation. To fully implement this recommendation, VHA needs to provide information about specific actions, described in the November 2019 update, taken to address the recommendation including documentation showing the actions taken to review the OSI goals and documentation of new OSI goals, metrics, and timelines.

Recommendation: The Assistant Secretary for Mental Health and Substance Use should establish procedures to better ensure that mid-performance changes to program priority goals, objectives, and targets are examined across multiple years. (Recommendation 1)

Agency: Department of Health and Human Services: Public Health Service: Substance Abuse and Mental Health Services Administration
Status: Open

Comments: As of October 2019, HHS reported that the Substance Abuse and Mental Health Services Administration (SAMHSA) would add new additional features to its web-based system for overseeing the mental health protection and advocacy programs, with an implementation target date of October 2020. The agency described one new feature as a tracking tool to monitor program requests to revise priority goals, objectives, and targets over multiple years. In the meantime, SAMHSA has developed a manual tracking tool for its project officers to use until the electronic tool is in place. Another new feature is a workflow that will allow project officers, team leaders, and branch chiefs to review and approve changes made by the programs. However, SAMHSA has not yet provided documentation of the latter feature to demonstrate that it has developed procedures for project officers to review the changes over multiple years. Therefore, the agency lacks assurances that its project officers will consistently examine whether a particular program is regularly making changes to benchmarks that may be indicative of a potential performance problem. We will review the web-based tracking tool when available and continue to monitor SAMHSA's efforts to develop procedures for examining changes to benchmarks over multiple years.

Recommendation: The Director of IHS should implement a targeted, resource-efficient method to identify additional eligible Indian homes that may have existing deficiencies to include in IHS's Home Inventory Tracking System (HITS). (Recommendation 1)

Agency: Department of Health and Human Services: Public Health Service: Indian Health Service
Status: Open

Comments: In August 2018, IHS's Division of Sanitation Facilities Construction issued a memo to its Area Directors directing them to identify additional eligible Indian homes that may have existing deficiencies to include in HITS. The memo directed Area Offices to use existing staffing resources to leverage their annual efforts to gather sanitation needs data, in collaboration with tribes, to identify any additional homes. In December 2019, IHS officials stated that, as a result of implementing the 2018 memo, Area Directors had increased the number of eligible homes that they identified in 2019. We will continue to monitor the results of IHS's actions.

Recommendation: The Director of IHS should implement a mechanism to indicate in HITS whether each home with a deficiency level of 0 has been assessed. (Recommendation 2)

Agency: Department of Health and Human Services: Public Health Service: Indian Health Service
Status: Open

Comments: As of December 2019, IHS had developed a mechanism in HITS to indicate whether a home currently classified as deficiency level (DL) 0 had been assessed. IHS stated that it has eliminated the category of DL 0 from HITS; in its place, it created a new category of "Pending Assessment" for those homes that are in HITS but that have not been assessed. IHS also came up with a way to prioritize the homes in the Pending Assessment category based on their eligibility to receive assistance from IHS. Homes currently in HITS that have a DL 0 and received service through the Sanitation Facilities Construction Program from 2015 through today will be reassigned a DL 1 to indicate the deficiencies are only associated with routine operations and maintenance. IHS stated that the changes to HITS have been implemented and shared a proposal of how it will distribute the former DL 0 homes across the new categories. We will evaluate IHS's actions after they are complete.

Recommendation: The Director of IHS should reassess the point distribution across the Sanitation Deficiency System scoring factors as part of its program guidelines update, in light of trade-offs between funding projects that address the most severe sanitation deficiencies and projects that meet other needs. (Recommendation 3)

Agency: Department of Health and Human Services: Public Health Service: Indian Health Service
Status: Open

Comments: As part of its reassessment of the point distribution across the scoring factors, in 2018 and 2019 IHS consulted with tribes and analyzed various options for changing the point distribution. We have asked IHS to provide additional information about its reassessment efforts. We will evaluate IHS's actions after we receive the additional information.

Recommendation: The Assistant to the Secretary of Agriculture for Rural Development should implement a scoring factor that awards points for proposed Native American program grant projects that address health risks from a lack of access to safe drinking water and wastewater disposal, as it does with the Colonias grant program. (Recommendation 4)

Agency: Department of Agriculture
Status: Open

Comments: As of January 2020, USDA stated it would prefer to use its discretionary points under its existing regulations to implement this scoring factor instead of making a regulation change to do so. USDA stated that using existing flexibility in the regulations could meet the intent of the recommendation more quickly than by permanently changing the regulation. USDA stated that it has established policy guidance to states that addresses scoring for projects with health and sanitation risks. We will monitor the actions that USDA has taken in response to this recommendation and evaluate them when complete.

Recommendation: The Director of IHS, in cooperation with other members of the tribal infrastructure task force, should review the 2011 task force report and identify and implement additional actions to help increase the task force's collaboration at the national level. (Recommendation 7)

Agency: Department of Health and Human Services: Public Health Service: Indian Health Service
Status: Open

Comments: As of December 2019, IHS had reviewed the 2011 task force report and summarized actions taken and challenges associated with implementing the remaining recommendations. IHS stated that it anticipated discussing its summary with the other members at a future tribal infrastructure task force meeting. We will evaluate IHS's actions when they are complete.

Recommendation: The Administrator of EPA, in cooperation with other members of the tribal infrastructure task force, should review the 2011 task force report and identify and implement additional actions to help increase the task force's collaboration at the national level. (Recommendation 8)

Agency: Environmental Protection Agency
Status: Open

Comments: As of June 2020, EPA had discussed the 2011 task force report with the other member agencies to identify and implement additional actions to increase collaboration at the national level. EPA published a summary matrix of relevant funding sources on the task force website and compiled a draft document summarizing actions the task force member agencies have taken to implement recommendations from the 2011 report. We will continue to monitor EPA's actions in response to this recommendation.

Recommendation: The Assistant to the Secretary of Agriculture for Rural Development, in cooperation with other members of the tribal infrastructure task force, should review the 2011 task force report and identify and implement additional actions to help increase the task force's collaboration at the national level. (Recommendation 9)

Agency: Department of Agriculture
Status: Open

Comments: In July 2019, the task force member agencies met to discuss the status of the recommendations in the 2011 task force report. The agencies each agreed to compile information about the actions they had taken and consider new actions in 2020. USDA stated in December 2018 that the task force agencies had made progress in developing efficiencies in environmental review processes and with online tribal resources and training, in addition to other areas. We will evaluate USDA's actions after the task force has compiled all actions taken in response to the 2011 report and evaluated what further actions or responses should be conducted.

Recommendation: The Deputy Assistant Secretary of the Department of Housing and Urban Development's Office of Native American Programs, in cooperation with other members of the tribal infrastructure task force, should review the 2011 task force report and identify and implement additional actions to help increase the task force's collaboration at the national level. (Recommendation 10)

Agency: Department of Housing and Urban Development
Status: Open

Comments: As of December 2019, the task force members had agreed to jointly consider the actions they have taken from the 2011 report and to discuss additional actions they could take to increase collaboration at the national level. We will evaluate HUD's actions once they are complete.

Recommendation: The Commissioner of Reclamation, in cooperation with other members of the tribal infrastructure task force, should review the 2011 task force report and identify and implement additional actions to help increase the task force's collaboration at the national level. (Recommendation 11)

Agency: Department of the Interior: Bureau of Reclamation
Status: Open

Comments: In April 2018, Reclamation met with other members of the task force and the agencies reviewed and discussed the 2011 task force report recommendations. As of December 2019, the task force members had agreed to jointly consider the actions they have taken from the 2011 report and to discuss additional actions they could take to increase collaboration at the national level. We will evaluate the agency's actions once they are complete.

Recommendation: The Director of IHS, in cooperation with other members of the tribal infrastructure task force, should direct IHS area offices to identify and pursue additional mechanisms to increase their collaboration. (Recommendation 12)

Agency: Department of Health and Human Services: Public Health Service: Indian Health Service
Status: Open

Comments: As of December 2019, IHS headquarters hosted a meeting that included staff from IHS Areas, EPA headquarters, and EPA regions to discuss additional mechanisms to increase collaboration, including best practices for identifying projects for joint funding collaborations. In addition, IHS and the other tribal infrastructure task force members agreed to jointly draft a memo for distribution to their field offices that would include contact information for other member agencies and encourage interagency coordination. We will evaluate IHS's remaining actions to satisfy this recommendation when they are complete.

Recommendation: The Assistant to the Secretary of Agriculture for Rural Development, in cooperation with other members of the tribal infrastructure task force, should direct USDA state offices to identify and pursue additional mechanisms to increase their collaboration. (Recommendation 13)

Agency: Department of Agriculture
Status: Open

Comments: In December 2018, USDA stated that it would send a memo to its state directors and program directors encouraging them to coordinate with tribal governments, IHS, EPA, and other members of the tribal infrastructure task force on funding infrastructure projects. As of December 2019, task force members had drafted a joint memo to distribute to their field offices encouraging additional coordination. We will evaluate USDA's actions in response to this recommendation once they are complete.

Recommendation: The Administrator of CMS should consider and take steps to mitigate the program risks that are not measured in the PERM, such as overpayments and unallowable costs; such an effort could include actions such as revising the PERM methodology or focusing additional audit resources on managed care. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open
Priority recommendation

Comments: CMS concurred with this recommendation. In October 2018, it reported that it was developing a plan to address the recommendation. CMS also reported that it has published several guidance documents and is in the process of finalizing others. In addition, it reported that it continues to develop educational strategies (such as a recent course managed care offered by CMS' Medicaid Integrity Institute) and oversight and audit strategies and mechanisms related to managed care. CMS communicated that it initiated 32 audits involving Medicaid managed care network providers in 6 states and an audit of a managed care plan in another state in FY 2018. For FY 2019, CMS stated that it will be establishing a medical loss ratio examination process and initiating such audits of managed care organizations in California. CMS also stated that it will be developing guidance for states and managed care plans on managed care delivery and oversight to develop program integrity capacity and reduce program risks. As of December 2019, CMS has not taken any additional steps; we will continue to monitor CMS's progress to mitigate the managed care program risks not measured in the PERM.

Recommendation: The Administrator of CMS should subject accessories essential to the group 3 power wheelchairs in the permanent DMEPOS program to prior authorization. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: In August 2018, the Department of Health and Human Services reported that it concurs with this recommendation and that CMS is exploring available options to subject accessories essential to the group 3 power wheelchairs in the permanent DMEPOS program to prior authorization. As of February 2020, HHS officials have not informed us of any actions taken to implement this recommendation. We will update the status of this recommendation when we receive additional information

Recommendation: The Administrator of CMS should take steps, based on results from evaluations, to continue prior authorization. These steps could include: (1) resuming the paused home health services demonstration; (2) extending current demonstrations; or, (3) identifying new opportunities for expanding prior authorization to additional items and services with high unnecessary utilization and high improper payment rates. (Recommendation 2)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open
Priority recommendation

Comments: In August 2018, the Department of Health and Human Services reported that it concurs with this recommendation. CMS has recently taken steps to evaluate and continue its prior authorization programs. In June 2019, CMS issued a final report on the independent evaluation of the non-emergency hyperbaric oxygen therapy demonstration. While the agency does not plan to conduct additional demonstrations on this service, CMS officials reported in December 2019 that the agency may consider this service for the new prior authorization process for certain hospital outpatient department services, established in a 2019 final rule. In April 2019, CMS issued a Federal Register notice that added 12 items-seven power wheelchairs and five pressure reducing support surfaces-to its required prior authorization list for the permanent program. CMS officials said in December 2019 that the agency was in the process of determining cost savings from this action and that additional items would be added to the list in early 2020. CMS resumed the home health services demonstration with changes in one state in June 2019 and in another state in September 2019. The agency plans to extend the demonstration to three additional states in 2020. In September 2019, CMS extended the repetitive scheduled non-emergency ambulance service demonstration for 1 year, through November 2020. GAO will continue to monitor issued agency guidance on the home health services demonstration and to evaluate additional steps CMS takes to evaluate and continue prior authorization in Medicare, such as determining cost savings from its actions and identifying new opportunities for prior authorization.

Recommendation: The Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to provide written documentation of DOD's approach to developing and approving the TRICARE Select access standards, as well as the final access standards, to Congress. (Recommendation 1)

Agency: Department of Defense
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The VHA Undersecretary for Health should provide updated guidance to VAMCs on the governance of the patient advocacy program, including clear definitions of reporting lines. (Recommendation 1)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open

Comments: VHA concurred with this recommendation and has provided regular updates on its progress in implementing it. As of April 2019, VHA's Office of Patient Advocacy (OPA) partnered with VA's Center for Healthcare Organization and Implementation Research (CHOIR) to better understand the current state of patient advocacy services in VHA, focusing on position descriptions, grade levels, and reporting structures. VA medical center staff completed questionnaires about the patient advocacy program in January 2019 and VHA analyzed the results. CHOIR officials are conducting site visits to interview key staff directly to identify the benefits and opportunities for improvements with patient advocacy services, including reporting structure. Upon completion of site visits to validate questionnaire findings, CHOIR will present their final recommendations to OPA. OPA will develop reporting structure guidance and work with workforce management and VHA senior leaders to communicate and implement the guidance. VHA's target completion for these efforts is December 2019.

Recommendation: The VHA Undersecretary for Health should assess and provide guidance to VAMCs on appropriately staffing the patient advocacy program, including guidance on how to determine the appropriate number and type of staff. (Recommendation 2)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open

Comments: VHA concurred with this recommendation and has provided regular updates on its progress in implementing it. As of April 2019, VHA's Office of Patient Advocacy (OPA) partnered with VA's Center for Healthcare Organization and Implementation Research (CHOIR) and VHA's Workforce Management to develop an evidence-based patient advocacy staffing model that accounts for facility size, complexity and geographic region. A set of questions was distributed to all VAMCs in December 2018. Responses to these questions have been analyzed by CHOIR, and on-site interviews at select facilities are in progress to validate the report findings. VHA's Workforce Management is working with CHOIR and OPA to use the results to develop a recommended and validated staffing model. This guidance will also be incorporated in the future revision of the VHA directive. The target completion of these efforts is December 2019.

Recommendation: The VHA Undersecretary for Health should monitor PATS data-entry practices to ensure all complaints are entered into PATS and that veterans' feedback is coded consistently. (Recommendation 5)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open

Comments: VHA concurred with this recommendation and has provided regular updates on its progress in implementing it. As of April 2019, VHA's Office of Patient Advocacy (OPA) receives a weekly report from both the Patient Advocate Tracking System (PATS) and PATS-Replacement (PATS-R) Systems reporting on the number of new cases entered at every VA medical center (VAMC). With development of the PATS-R web-based tool, OPA, the Veterans Experience Office and the PATS-R developers have conducted a review of existing codes and are currently working with various VHA program offices to standardize codes across various data systems. VA plans to develop an auditing toolkit to ensure standardized, timely documentation of complaints, including accurate coding within PATS. The target completion date for these efforts is December 2019.

Recommendation: The Director of ONDCP, in collaboration with law enforcement and public health counterparts, should lead a review on ways to improve the timeliness, accuracy, and accessibility of fatal and non-fatal overdose data from law enforcement and public health sources that provide critical information to understand and respond to the opioid epidemic. Such a review should expand on and leverage the findings from previous federal studies. It should also assess the benefits and scalability of ongoing efforts to leverage data systems, such as the Washington-Baltimore High-Intensity Drug Trafficking Areas' (HIDTA) OD MAP program, and examine ways in which laws that restrict access to public health data to protect patient privacy have exemptions for law enforcement entities that could be more widely leveraged while protecting patient privacy. (Recommendation 2)

Agency: Executive Office of the President: Office of National Drug Control Policy
Status: Open

Comments: In the 60-day letter, dated June 28, 2018, ONDCP officials noted a number of federal initiatives underway to evaluate the timeliness, accuracy, and accessibility of overdose data. For example, ONDCP discussed its participation in a new Interagency Working Group led by the National Security Council to consider the implementation of overdose tracking and analytic capability, such as the expansion of ODMAP, as well as evaluating the appropriate federal role to engage in this initiative. In March 2019, ONDCP reported that it had suspended its ODMAP working group in the summer of 2018, after determining that this effort would be more effective for the Department of Justice's Bureau of Justice Assistance (BJA) and the Centers for Disease Control and Prevention (CDC) to work together through the Comprehensive Opioid Abuse Program Initiative. Nevertheless, as of April 2019, ONDCP officials reported that they continue to provide grant funding and training and technical assistance towards the expansion and use of ODMAP by state and local jurisdictions. Further, ONDCP reported supporting other federal data initiatives, such as providing funding to develop software for the CDC's National Center for Health Statistics Mortality Data that could better read narrative fields in death certificates to improve the timeliness and accuracy of the data. While ONDCP's efforts are directed towards supporting and improving existing data sources, the recommendation asks ONDCP to lead a review which it has not done. Further, ONDCP's initiatives to date have not addressed issues raised in our report related to balancing law enforcement's access to restricted health data while protecting patient privacy. We will continue to monitor ONDCP's efforts towards implementing this recommendation.

Recommendation: The Director of ONDCP should work with the HIDTAs participating in the Heroin Response Strategy to establish outcome-oriented performance measures for the four main goals set out in the strategy. (Recommendation 3)

Agency: Executive Office of the President: Office of National Drug Control Policy
Status: Open

Comments: In the 60-day letter, dated June 28, 2018, ONDCP officials stated that they had engaged with leaders from HIDTA participating in the Heroin Response Strategy to develop performance measures. According to ONDCP, as of early May 2018, eleven performance measures had been established--nine mandatory measures and two optional measures--and four of these measures constitute outcome-oriented measures. The June letter also noted that the HIDTA Performance Management Process database was being updated to reflect the new measures and ONDCP expected the system to be fully operational by the end of September 2018. In March 2019, ONDCP reported that, throughout the summer of 2018, it had revisited the performance measures it had developed and settled on ten revised performance measures (eight mandatory measures and two optional measures) for the newly branded Opioid Response Strategy (formerly known as the Heroin Response Strategy). According to ONDCP, these measures were implemented in HIDTA's Performance Management Process as of February 1, 2019. We will continue to coordinate with ONDCP to obtain documentation of these new measures. Once we obtain them, we will review and work toward closing the recommendation, as appropriate.

Recommendation: The Executive Director of Organized Crime Drug Enforcement Task Forces should work with the National Heroin Initiative Coordinator to establish outcome-oriented performance measures for the goals set out for National Heroin Initiative. (Recommendation 4)

Agency: Department of Justice: Organized Crime Drug Enforcement Task Forces
Status: Open
Priority recommendation

Comments: In its 60 Day-letter, dated June 26, 2018, officials from the Organized Crime Drug Enforcement Task Force (OCDETF) noted the output metrics and statistics that OCDETF is tracking as part of its National Heroin Initiative. For example, the letter states that OCDETF will track statistics on opioid overdose deaths, however it is unclear how this tracking effort is being incorporated into the National Heroin Initiative. While our report noted that statistics on overdose deaths have been used as outcome-oriented measures by agencies like the Office of National Drug Control Policy to assess its efforts, it is unclear how OCDETF is using these statistics to assess its performance and inform its efforts under the National Heroin Initiative. In October 2018, OCDETFs National Heroin Initiative Coordinator told us that the OCDETF Regional Directors were in the process of establishing and tracking region-specific metrics, such as local data on drug overdoses. In January 2020, we reached out to OCEDTF officials for an update, and they did not have any further information to provide. In August 2020, OCDETF officials told us that the National Heroin Initiative had evolved and they are no longer positioned to collect and report on drug overdoses as a performance measure for the initiative. However, officials stated that the initiative is measuring the number of OCDETF cases that are produced that result in the disruption or dismantlement of criminal networks involved in heroin and opioid trafficking. We asked OCDETF to provide documentation of the current state of the initiative and its related goals and performance measures. Once received, we will review and follow-up with OCDETF, if needed, to work towards the closure of the recommendation as implemented.

Recommendation: The Attorney General should, in consultation with its relevant components such as the Drug Enforcement Administration (DEA) and Executive Office for United States Attorneys (EOUSA), establish goals and outcome oriented performance measures for its Strategy to Combat the Opioid Epidemic. (Recommendation 5)

Agency: Department of Justice
Status: Open
Priority recommendation

Comments: In its 60 Day-letter, dated June 26, 2018, DOJ officials reported a number of output measures, such as conviction rates, that they will use to assess the effectiveness of the department's efforts to respond to the opioid epidemic. However, it is unclear how, if all, these measures have been incorporated into the department-wide strategy or if additional outcome-oriented metrics are being developed. In October 2018, DOJ officials reported that while they have not updated the strategy, then-Attorney General Sessions had issued a memo to the U.S. Attorneys that communicated some goals for their efforts, such as reductions in overdose deaths, and called for the U.S. Attorneys Office's Regional Opioid Coordinators to develop metrics specific to their regions. In October 2019, DOJ officials reported that the department is currently working on finalizing its Annual Priority Goals and related performance measures with respect to opioids, however they could not provide additional details nor a timeline for when these efforts are to be completed. We reached out in January 2020 to receive additional details and the Department did not have any further information to provide. We will continue to coordinate with DOJ to learn more about these efforts and when officials expect them to be implemented.

Recommendation: The DEA Administrator should establish goals and outcome-oriented performance measures for the enforcement and diversion control activities within the 360 Strategy and establish outcome-oriented performance measures for the community engagement activities within the 360 Strategy. (Recommendation 6)

Agency: Department of Justice: Drug Enforcement Administration
Status: Open
Priority recommendation

Comments: In its 60-Day Letter, dated June 26, 2018, DEA officials noted the steps they had taken to develop performance metrics for its enforcement and diversion control activities under the 360 Strategy and reported that DEA had implemented outcome-oriented performance metrics for the 360 Strategy's community engagement activities for fiscal year 2019. Further, DEA officials noted applying DEA's Threat Enforcement Planning Process (TEPP) specifically to the 360 Strategy to develop outcome-oriented metrics. Further, according to DEA officials, the TEPP includes an impact report that assesses the outcomes of the activities undertaken under 360. In October 2018, DEA told us that TEPP was still in development and they did not give a date for projected completion. In January 2020, we reached out to DEA officials for an update, and they did not have any further information to provide. We will continue to follow up with DEA officials on their progress.

Recommendation: The Administrator of CMS should ensure that CMS has complete data on terminations of enrollee coverage for nonpayment of premiums by requiring issuers to report these data. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Administrator of CMS should provide a transparent process for issuers and CMS to systematically reconcile discrepancies in their data on terminations of enrollee coverage for nonpayment of premiums. (Recommendation 2)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of HHS should coordinate with federal agencies, including VA, that fund GME training to identify information needed to evaluate the performance of federal programs that fund GME training, including the extent to which these programs are efficient and cost-effective and are meeting the nation's health care workforce needs. (Recommendation 1)

Agency: Department of Health and Human Services
Status: Open

Comments: In January 2020, HHS indicated that the agency had not yet taken steps to identify information needed to evaluate the performance of federal programs that fund GME training, including the extent to which these programs are efficient and cost-effective and are meeting the nation's health care workforce needs. HHS reiterated its comments on GAO's report, noting that the President's fiscal year 2020 budget for HHS proposed consolidating federal spending from Medicare, Medicaid, the Teaching Health Center Graduate Medical Education Program, and the Children's Hospitals Graduate Medical Education Payment Program into a single grant program for teaching hospitals. The President's fiscal year 2021 budget for HHS also included this proposal. It noted that such a restructuring would allow the Department to set expectations for program performance in Medicare and Medicaid GME programs and allow the kind of tracking HRSA has been able to implement in the Children's Hospital GME program and its Teaching Hospital GME program. It noted that Congress had not responded to this request. As GAO noted in its 2018 report, this recommendation stands on its own and is separate from any legislative efforts to modify how federal GME funds are distributed. Whether or not legislation is enacted to implement a consolidated federal GME grant program, HHS should take action to identify information needed to evaluate the performance of federal programs that fund GME training. Such action is important for HHS to assure that federal programs fully meet workforce needs. However, HHS did not otherwise indicate whether it had coordinated with federal agencies that fund GME training. As of January 2020, this proposal had not been adopted.

Recommendation: The Secretary of HHS should coordinate with federal agencies to identify opportunities to improve the quality and consistency of the information collected within and across federal programs, and implement these improvements. (Recommendation 2)

Agency: Department of Health and Human Services
Status: Open

Comments: In January 2020, HHS indicated that the agency had not yet taken steps to identify opportunities to improve the quality and consistency of the information collected within and across federal programs, and implement these improvements. HHS reiterated its comments on GAO's report, noting that the President's fiscal year 2020 budget for HHS proposed consolidating federal spending from Medicare, Medicaid, the Teaching Health Center Graduate Medical Education Program, and the Children's Hospitals Graduate Medical Education Payment Program into a single grant program for teaching hospitals. The President's fiscal year 2021 budget for HHS also included this proposal. It noted that such a restructuring would allow the Department to set expectations for program performance in Medicare and Medicaid GME programs and allow the kind of tracking HRSA has been able to implement in the Children's Hospital GME program and its Teaching Hospital GME program. It noted that Congress had not responded to this request. As GAO noted in its 2018 report, this recommendation stands on its own and is separate from any legislative efforts to modify how federal GME funds are distributed. Whether or not legislation is enacted to implement a consolidated federal GME grant program, HHS should take action to identify information needed to evaluate the performance of federal programs that fund GME training. Such action is important for HHS to assure that federal programs fully meet workforce needs. However, HHS did not otherwise indicate whether it had coordinated with federal agencies that fund GME training. As of February 2020, this proposal had not been adopted.

Recommendation: The Secretary of the Army should develop targeted strategies for using its recruitment, training, and retention programs collectively to address key military physician gaps in a coordinated manner, and metrics that would monitor the effectiveness of its programs collectively in reducing gaps. (Recommendation 1)

Agency: Department of Defense
Status: Open

Comments: Army concurred with this recommendation. In October 2019, the Army reported that several steps have been taken, including creating a 6-year health professions officer retention bonus for critically short physician specialties; increased the number of Health Professions Scholarship Program scholarships to help decrease the overall physician shortfalls; and added a recruiting mission using Financial Assistance Program (FAP) scholarships to help decrease the physician shortfall in critical specialties. The FAP mission is to begin in fiscal year 2020. While the steps Army reported demonstrate progress toward fully implementing our recommendation, we believe that this recommendation should remain open until more progress is made.

Recommendation: The Secretary of the Navy should develop targeted strategies for using its recruitment, training, and retention programs collectively to address key military physician gaps in a coordinated manner, and metrics that would monitor the effectiveness of its programs collectively in reducing gaps. (Recommendation 2)

Agency: Department of Defense
Status: Open

Comments: Navy concurred with this recommendation. In October 2019, Navy officials stated that several steps have been taken, including exploring policy changes that would assist in meeting requirements. According to Navy officials, a working group has been formed which will address recruitment and retention of all critical specialties and plan to issue an end product by June 2020.

Recommendation: The Secretary of the Air Force should develop targeted strategies for using its recruitment, training, and retention programs collectively to address key military physician gaps in a coordinated manner, and metrics that would monitor the effectiveness of its programs collectively in reducing gaps. (Recommendation 3)

Agency: Department of Defense
Status: Open

Comments: Air Force concurred with our recommendation. In October 2019, the Air Force reported that several steps have been taken; including developing a sustainable process for improved marketing of key specialties to students and increasing the number of Health Professions Scholarship Program scholarships. While the steps Air Force reported demonstrate progress toward fully implementing our recommendation, we believe that this recommendation should remain open until more progress is made.

Recommendation: The Secretary of the Navy should track complete, accurate, and accessible information on the qualifications, performance, and progress of Navy AFHPSP medical students. (Recommendation 5)

Agency: Department of Defense
Status: Open

Comments: Navy concurred with this recommendation. In November 2018, the Navy changed its Navy Standard Integrated Personnel System (NSIPS) to allow tracking of qualification data fields. As of October 2019, the Navy reported it is taking steps to update NSIPS to track the complete performance and progress of AFHPSP medical students. While the steps Navy reported demonstrate progress toward fully implementing our recommendation, we believe that this recommendation should remain open until more progress is made.

Recommendation: The Secretary of the Air Force should track complete, accurate, and accessible information on the qualifications, performance, and progress of Air Force AFHPSP medical students. (Recommendation 6)

Agency: Department of Defense
Status: Open

Comments: Air Force concurred with this recommendation. In August 2018, the Air Force updated guidance to emphasize the requirement for accurate and complete reporting of qualification data of AFHPSP medical students. As of October 2019, the Air Force reported that it is partnering with the Army and Navy to secure a tri-service database to track students' performance across the continuum of learning. While the steps Air Force reported demonstrate progress toward fully implementing our recommendation, we believe that this recommendation should remain open until more progress is made.

Recommendation: The President of Uniformed Services University of the Health Sciences (USUHS) should track complete, accurate, and accessible information on the performance and progress of USUHS medical students. (Recommendation 7)

Agency: Department of Defense
Status: Open

Comments: Uniformed Services University of the Health Sciences concurred with our recommendation. In October 2019, the University reported that issues relevant to tracking its students continue to be researched and have offered to collaborate with the military departments. While the steps the University reported demonstrate progress toward fully implementing our recommendation, we believe that this recommendation should remain open until more progress is made.

Recommendation: The Secretary of the Navy should use information on medical student performance to evaluate Navy accession programs. (Recommendation 8)

Agency: Department of Defense
Status: Open

Comments: Navy concurred with this recommendation. In October 2019, the Navy reported that the Navy Standard Integrated Personnel System (NSIPS) now contains qualification data of AFHPSP medical students and also has some performance data of these students as they compete their post graduate training. NPSIS is capable of being queried and this data, according to the Navy, can be used to evaluate its accession programs. While the steps Navy reported demonstrate progress toward fully implementing our recommendation, we believe that this recommendation should remain open until more progress is made.

Recommendation: The Secretary of the Air Force should use information on medical student performance to evaluate Air Force accession programs. (Recommendation 9)

Agency: Department of Defense
Status: Open

Comments: Air Force concurred with our recommendation. In October 2019, the Air Force reported it plans to annually track and analyze information regarding its AFHPSP medical students and it is in the process of performing its annual review. While the steps Air Force reported demonstrate progress toward fully implementing our recommendation, we believe that this recommendation should remain open until more progress is made.

Recommendation: The Secretary of HHS should direct ACF to provide additional guidance and technical assistance to states to address known challenges and enhance their understanding of CAPTA requirements, including the requirements for health care providers to notify CPS of substance-affected infants and the development of a plan of safe care for these infants.

Agency: Department of Health and Human Services
Status: Open

Comments: HHS did not agree with this recommendation. The agency stated that it clarified guidance in the areas we raised. HHS also believes it is necessary to allow states the flexibility to meet the requirements in the context of their state CPS program. However, we found that states reported issues with the guidance and it did not address a key ongoing challenge regarding CAPTA requirements. HHS indicated that it will continue to provide technical assistance to states and fund demonstration sites to establish or enhance collaboration across community agencies and courts. Although continuing to provide technical assistance to states should be beneficial, our findings demonstrate that additional guidance is also needed. We continue to believe our recommendation is warranted. As of February 2020, the agency continues to disagree.

Recommendation: The Administrator of CMS should issue written criteria for when CMS will allow limited evaluation of a demonstration or a portion of a demonstration, including defining conditions, such as what it means for a demonstration to be longstanding or noncomplex, as applicable. (Recommendation 2)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS agreed with this recommendation. In November 2019, HHS reported that it was applying limited evaluation requirements to certain demonstration types, including routine family planning demonstrations. In July 2020, CMS stated that it continues to work with states as they apply for new or extensions of approved demonstrations to determine whether the demonstrations as a whole or certain components would qualify for limited evaluation. The agency, however, reiterated that it needs more experience before developing generalized guidance and that was not a priority for 2020. We will continue to monitor CMS's progress and will review whether to close the recommendation when these criteria are issued.

Recommendation: The Administrator of CMS should provide guidance and clarify requirements regarding the monitoring and reporting of deficiencies that states using home and community-based services (HCBS) waivers are required to report on their annual reports. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: CMS concurred with this recommendation and indicated the agency would provide guidance and clarify requirements regarding the monitoring and reporting of deficiencies in states' annual reports. According to CMS's fiscal year 2021 Budget Justification the agency expects to issue sub-regulatory guidance pertaining to health and welfare of Medicaid beneficiaries in residential facilities by the close of 2020.To fully implement this recommendation, the sub-regulatory guidance should clarify requirements for states' monitoring and reporting of deficiencies in HCBS annual reports. GAO will continue to monitor CMS actions in response to this recommendation.

Recommendation: The Administrator of CMS should establish standard Medicaid reporting requirements for all states to annually report key information on critical incidents, considering, at a minimum, the type of critical incidents involving Medicaid beneficiaries, and the type of residential facilities, including assisted living facilities, where critical incidents occurred. (Recommendation 2)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open
Priority recommendation

Comments: HHS neither agreed nor disagreed with this recommendation. According to CMS' fiscal year 2021 Budget Justification, the agency expects to issue sub-regulatory guidance pertaining to health and welfare of Medicaid beneficiaries in residential facilities by the close of 2020. To fully implement this recommendation, the sub-regulatory guidance should establish standard Medicaid reporting requirements for all states to report critical incidents annually. GAO will continue to monitor CMS actions in response to this recommendation.

Recommendation: The Administrator of CMS should ensure that all states submit annual reports for HCBS waivers on time as required. (Recommendation 3)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: CMS concurred with this recommendation and stated that it will review and update its communications with states to reaffirm reporting requirements and ensure that all HCBS annual reports are submitted on time. According to CMS' fiscal year 2021 Budget Justification, the agency expects to issue sub-regulatory guidance pertaining to the health and welfare of Medicaid beneficiaries in residential facilities by the close of 2020. To fully implement this recommendation, the sub-regulatory guidance should ensure that all states submit annual reports on time. GAO will continue to monitor CMS actions in response to this recommendation.

Recommendation: The Commissioner of FDA should develop performance metrics and use them to evaluate the implementation of the least burdensome requirements, such as during its planned audits of medical device deficiency letters. (Recommendation 1)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: In July 2019, FDA reported on efforts to increase device staff knowledge of least burdensome requirements and the implementation of a "least burdensome flag," which allows the submitter to flag a submission for FDA if it believes that the agency's request is not the least burdensome or that it was being held to an inappropriate review standard. In August 2020, FDA described its analysis of the flags, including the number of times it was used and the time it took to resolve them relative to FDA's goal. FDA indicated that it will continue to monitor the usage of the flag program to identify signals or trends that should be addressed. The agency indicated that the recommendation should remain open, and GAO will continue to monitor the implementation of this recommendation.

Recommendation: The Administrator of CMS should ensure that all types of Medicaid HCBS programs have requirements for states to avoid or mitigate potential conflicts of interest on the part of entities that conduct needs assessments that are used to determine eligibility for HCBS and to develop HCBS plans of service. These requirements should address both service providers and managed care plans conducting such assessments. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS concurred with our recommendation. However, in an April 2018 update, HHS noted that the recommendation should be closed based on existing Medicaid regulations. GAO disagrees. The existing regulations--which GAO reviewed at the time of this study--do not address all types of Medicaid HCBS programs. For example, specific conflict of interest requirements are generally not in place for needs assessments that are used to inform HCBS eligibility determinations. Similarly, managed care plans may have a financial interest in the outcome of HCBS assessments used for both determining eligibility and service amounts. GAO maintains that states should be required to avoid or mitigate potential conflicts of interest on the part of entities-including both service providers and managed care plans-that perform the needs assessments that states use for eligibility determinations and to develop plans of service. As of December 2019, HHS officials have not informed us of any additional actions taken to ensure that states avoid or mitigate potential conflict of interests in needs assessments for all types of Medicaid HCBS programs. We will update the status of this recommendation when we receive additional information.

Recommendation: The Administrator of CMS, in partnership with the states, should take additional steps to expedite the use of T-MSIS data for program oversight. Such steps should include, but are not limited to, efforts to (1) obtain complete information from all states on unreported T-MSISdata elements and their plans to report applicable data elements; (2) identify and share information across states on known T-MSIS datalimitations to improve data comparability; and (3) implement mechanisms, such as the Learning Collaborative, by whichstates can collaborate on an ongoing basis to improve thecompleteness, comparability, and utility of T-MSIS data.(Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open
Priority recommendation

Comments: HHS concurred with this recommendation. As of February 2020, CMS has taken steps to improve T-MSIS data quality, but further efforts are needed to expedite the data's use in oversight. With regard to obtaining complete information from all states, CMS released additional guidance in March 2019, on state compliance with T-MSIS requirements. This guidance includes the need to resolve data issues associated with 12 top priority items and missing data elements, both of which are key for using T-MSIS data. Further, CMS identified an additional 11 top priority items, noting it also expected states to resolve data issues with these items. CMS reports that it has helped resolve data issues related to these 23 top priority items by sending states summary data on compliance with associated reporting requirements. CMS has notified states of their compliance status and asked non-compliant states to submit corrective action plans. However, CMS reports that the level of states' T-MSIS data completeness varies and agency state liaisons and technical assistants continue to work individually with states to identify, prioritize, and resolve key missing data elements. With regard to identifying and sharing information, CMS has made some T-MSIS data available for use through five T-MSIS analytical files, which include data on Medicaid and CHIP enrollment, demographics, service utilization, and payments. Further, CMS has created resources to support researchers in their use of these analytical files, including information on the completeness and accuracy of certain data elements. With regard to implementing mechanisms for collaboration across states, additional CMS action is needed. In particular, CMS's efforts to create a mechanism for states to disseminate information about T-MSIS data and its comparability across states remain limited and the agency has not launched its proposed Learning Collaborative to facilitate ongoing feedback and collaboration. While progress has been made, additional actions, such as establishing mechanisms for ongoing feedback and collaboration across states, are needed to consider this recommendation implemented.

Recommendation: The Administrator of CMS should articulate a specific plan and associated time frames for using T-MSIS data for oversight. (Recommendation 2)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS concurred with this recommendation. As of February 2020, CMS has taken steps to articulate guidance to states, but has not outlined a specific plan and associated time frames for using T-MSIS data for oversight. Until CMS takes these actions, the recommendation remains open.

Recommendation: The Administrator of CMS should provide fraud-awareness training relevant to risks facing CMS programs and require new hires to undergo such training and all employees to undergo training on a recurring basis. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: The agency agreed with this recommendation. In July 2018, CMS reported that it is strengthening its efforts to ingrain fraud risk management principles throughout the Agency and is developing a training video, module, and curriculum to train staff agency-wide on fraud risks. In November 2019, CMS provided fraud-awareness training videos for new and current CMS employees. GAO requested and is awaiting documentation to show mandatory nature and annual frequency of the training in order to assess the extent to which the training is consistent with leading practices in fraud risk management.

Recommendation: The Administrator of CMS should conduct fraud risk assessments for Medicare and Medicaid to include respective fraud risk profiles and plans for regularly updating the assessments and profiles. (Recommendation 2)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: Agency agreed with this recommendation. In July 2018, CMS reported that it has initiated the fraud risk assessment for some programs in Medicare, including the Medicare Diabetes Prevention Program expanded model. CMS also reported that it is also continuing to draft fraud risk profiles for the Comprehensive End-Stage Renal Disease (ESRD) Care model, the Comprehensive Primary Care Plus model, the permanent Medicare Shared Savings Program, and the new Medicare Beneficiary Identifier. Additionally, CMS reported that it is assessing the Quality Payment Program, established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), utilizing the GAO fraud risk assessment framework. We will continue to monitor CMS's progress in this area. In November 2019, CMS provided a diagram depicting CMS approach to assessing fraud risks and a document for Home Health Request for Anticipated Payment, stating that fraud risk assessments on Medicare Diabetes Prevention Program and Quality Payment Program are under development. We requested and are awaiting additional information on CMS's approach and plans for conducting fraud risk assessments in Medicare programs, including the reasoning for program selection, overall order, and anticipated timeframes.

Recommendation: The Administrator of CMS should, using the results of the fraud risk assessments for Medicare and Medicaid, create, document, implement, and communicate an antifraud strategy that is aligned with and responsive to regularly assessed fraud risks. This strategy should include an approach for monitoring and evaluation. (Recommendation 3)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: Agency agreed with this recommendation. In November 2019, CMS reported on activities to conduct fraud risk assessments in Medicare programs (see Recommendation 2), however this work is ongoing and the recommendation remains open. Because completion of a fraud risk assessment is necessary before developing an antifraud strategy, this recommendation also remains open. We will continue to monitor CMS's progress in this area.

Recommendation: The Under Secretary for Health should specify in VHA policy that reviews of providers' clinical care after concerns have been raised should be documented, including retrospective and comprehensive reviews. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open

Comments: VA agreed with the recommendation and indicated plans to revise policy to codify requirements to document reviews. As of April 2020, VA estimates completing these and other revisions to the policy in August 2020.

Recommendation: The Under Secretary for Health should specify in VHA policy a timeliness requirement for initiating reviews of providers' clinical care after a concern has been raised. (Recommendation 2)

Agency: Department of Veterans Affairs
Status: Open

Comments: VA agreed with the recommendation and indicated plans to revise policy to incorporate timeline expectations for initiating reviews after clinical care concerns have been raised. As of April 2020, VA estimates completing these and other revisions to the policy in August 2020.

Recommendation: The Director of the MSPV-NG program office should, with input from the Strategic Acquisition Center (SAC), develop, document, and communicate to stakeholders an overarching strategy for the program, including how the program office will prioritize categories of supplies for future phases of requirement development and contracting. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open
Priority recommendation

Comments: The Department of Veterans Affairs (VA) agreed with GAO's November 2017 recommendation. VA planned to implement a new Medical-Surgical Prime Vendor (MSPV) program, called MSPV 2.0, by March 2020; however, this program has been delayed to at least January 2021. MSPV 2.0 includes a process where clinicians review requirements for a set list of products. As of August 2020, VA is beginning the national rollout of this clinician review process, but the results of this process won't be implemented until after MSPV 2.0 begins. VA's strategy for its MSPV program depends on full implementation of this clinician review process.

Recommendation: The Director of the MSPV-NG program office should provide complete guidance to medical centers for matching equivalent supply items, which could include defining the roles of clinicians and local Clinical Product Review Committees. (Recommendation 4)

Agency: Department of Veterans Affairs
Status: Open

Comments: The Department of Veterans Affairs (VA) agreed with GAO's November 2017 recommendation. VA implemented a tool-the Medical Product Data Bank's eZSAVE application-to improve the matching of equivalent supply items. In November 2018, VA reported that it holds monthly meetings with selected clinical and logistics staff to obtain their input on the matching process. However, as of August 2020, VA has not provided documentation showing how it has defined the role of clinical staff, including Clinical Product Review Committees, in this process. Without documentary support, GAO cannot assess the extent of the clinical staff role in the matching process. If the roles of clinicians are not clearly defined, it increases the risk of inconsistent involvement in the matching process.

Recommendation: The VHA Chief Procurement and Logistics Officer should use input from national clinical program offices to prioritize its MSPV-NG requirements development and standardization efforts beyond Phase 2 to focus on supply categories that offer the best opportunity for standardization and cost avoidance. (Recommendation 8)

Agency: Department of Veterans Affairs
Status: Open

Comments: The Department of Veterans Affairs (VA) agreed with GAO's November 2017 recommendation. VA's planned Medical-Surgical Prime Vendor (MSPV) 2.0 program includes engaging selected clinicians in its requirement development for a set list of products, known as Clinician-Driven Strategic Sourcing. In April 2019, VA began a pilot for this clinician review process, including input from national clinical program offices. As of August 2020, VA is beginning the national rollout of this process. VA does not plan to incorporate the results of this clinician review process in the list of available supplies until after MSPV 2.0 is implemented, which has been delayed until at least January 2021. Until VA implements MSPV 2.0 and incorporates the results of the Clinician-Driven Strategic Sourcing process, it will not be able to achieve its goals of cost savings and improved clinical consistency.

Recommendation: The VHA Chief Procurement and Logistics Officer should direct Veterans Integrated Service Network (VISN) Network Contracting Offices to work with medical centers to identify any opportunities to more strategically purchase goods and services frequently purchased on an emergency basis. For example, offices could do this by analyzing existing data. (Recommendation 9)

Agency: Department of Veterans Affairs
Status: Open

Comments: The Department of Veterans Affairs (VA) agreed with GAO's November 2017 recommendation. In August 2019, senior VA acquisition officials agreed to conduct an analysis of its spending to identify items that the department frequently purchases on an emergency basis and to develop plans to purchase those goods and services more strategically, such as by issuing a national contract or adding the items to the formulary as needed. As of August 2020, these officials indicated they would provide this analysis to GAO by the end of 2020.

Recommendation: VHA Chief Procurement and Logistics Officer should analyze data on items that are frequently purchased on an emergency basis, determine whether such items are suitable to be added to the MSPV-NG formulary, and work with SAC to make any suitable items available via MSPV-NG. (Recommendation 10)

Agency: Department of Veterans Affairs
Status: Open

Comments: The Department of Veterans Affairs (VA) agreed with GAO's November 2017 recommendation. VA reported that it added thousands of items to the Medical-Surgical Prime Vendor (MSPV) formulary from June 2018 through December 2018, some of which had previously been purchased on an emergency basis. VA also reported in June 2018 and updated in March of 2020 that it is tracking items purchased on an emergency basis. However, as of August 2020, VA has not provided documentation showing whether and how this analysis has informed its selection of which products to add to the formulary. Without documentary support, GAO cannot assess the extent to which items that VA added to the formulary were previously purchased on an emergency basis. If VA does not use analysis of emergency procurements to help inform which items should be added to the MSPV formulary, it will miss opportunities to avoid emergency procurements and increase efficiency.

Recommendation: The Undersecretary for Health should develop and implement a process to accurately count all physicians providing care at each medical center, including physicians who are not employed by VHA. (Recommendation 1)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open
Priority recommendation

Comments: As of January 2020, VHA continues to disagree with the recommendation and has not taken any action. Although VA responded to our report by stating that the ability to count physicians does not affect its ability to assess workload, we maintain that an accurate count of all physicians providing care at each medical center is necessary for accurate workforce planning. To implement the first recommendation, VHA needs to develop a system-wide process to collect information on all physicians providing care at VAMCs, including physicians that are not employed by VHA. This information should be available at the local level for workforce planning purposes.

Recommendation: The Undersecretary for Health should develop and issue guidance to the VAMCs on determining appropriate staffing levels for all mission-critical physician occupations. (Recommendation 2)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open

Comments: VHA concurred with this recommendation. In November 2017, VHA's Executive in Charge chartered the Specialty Care Provider Staffing and Network Model Workgroup to develop a methodology for determining the scope and complexity of specialty care services. The Workgroup also developed an analytical tool to support local decision-making around specialty staffing levels. According to VHA, the Specialty Care Services Staffing model has been validated across some VHA regions. The Workgroup was directed to develop an Executive Decision Memorandum for an official determination as to implementation of the model. As of January 2020, VHA was awaiting the results of the Governing Board's decision on the Executive Decision Memorandum, the guidance documents, and analytical template. VHA reported the target date for completion is March 2020.

Recommendation: The Undersecretary for Health should establish a system-wide method to share information about physician trainees to help fill vacancies across VAMCs. (Recommendation 4)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open

Comments: VHA concurred with this recommendation. VHA is working to develop the necessary capacity to enable a system-wide method for sharing information about physician trainees to help fill vacancies. In April 2019, VHA anticipated having this system in place by the end of fiscal year 2019. However, VHA has not submitted any additional information since April 2019. VHA has also created a VHA-Trainee Recruitment and Hiring Workgroup (the Workgroup). The Workgroup serves as the advisory group on trainee recruitment and hiring, for the purpose of developing a permanent Trainee Recruitment and Hiring Function. The Workgroup is holding Virtual Trainee Recruitment Events for critical occupations. Until GAO sees evidence of a system-wide method for sharing information about physician trainees, this recommendation will remain open.

Recommendation: To improve technical expertise and overcome fragmentation, the CDC director of the Select Agent Program should work with APHIS to develop a joint workforce plan that assesses workforce and training needs for the program as a whole. This assessment should be done in conjunction with the development of the strategic plan. (Recommendation 10)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
Status: Open

Comments: CDC agreed with this October 2017 recommendation and, as of January 2020, CDC and APHIS were in the process of finalizing a joint workforce assessment focusing primarily on inspections, according to officials from the Select Agent Program. However, this joint assessment does not account for other aspects of the program, such as training, which was part of GAO's recommendation. According to Select Agent Program officials, the program is developing a new information system and officials plan to conduct a follow-up workload assessment once this new system is fully implemented, as they anticipate that the program will gain efficiencies once this new system is in place. Officials from the Select Agent Program said they did not have a definitive timeframe as to when the new system would be in place and a new workload assessment could be completed but, as of December 2019, they said it would be several years. Once the updated workforce assessment is completed, GAO will review it to determine if it fulfills the recommendation. Developing a joint workforce plan as recommended would help the program to better manage fragmentation by improving how it leverages resources, which in turn would help to ensure that all workforce and training needs are met.

Recommendation: To improve technical expertise and overcome fragmentation, the APHIS director of the Select Agent Program should work with CDC to develop a joint workforce plan that assesses workforce and training needs for the program as a whole. This assessment should be done in conjunction with the development of the strategic plan. (Recommendation 11)

Agency: Department of Agriculture: Animal and Plant Health Inspection Service
Status: Open

Comments: APHIS agreed with this October 2017 recommendation and, as of January 2020, CDC and APHIS were in the process of finalizing a joint workforce assessment focusing primarily on inspections, according to officials from the Select Agent Program. However, this joint assessment does not account for other aspects of the program, such as training, which was part of GAO's recommendation. According to Select Agent Program officials, the program is developing a new information system and officials plan to conduct a follow-up workload assessment once this new system is fully implemented, as they anticipate that the program will gain efficiencies once this new system is in place. Officials from the Select Agent Program said they did not have a definitive timeframe as to when the new system would be in place and a new workload assessment could be completed but, as of December 2019, they said it would be several years. Once the updated workforce assessment is completed, GAO will review it to determine if it fulfills the recommendation. Developing a joint workforce plan as recommended would help the program to better manage fragmentation by improving how it leverages resources, which in turn would help to ensure that all workforce and training needs are met.

Recommendation: The Administrator of CMS should require plan sponsors to report to CMS on investigations and other actions taken related to providers who prescribe high amounts of opioids. (Recommendation 3)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS did not concur with this recommendation. As of September 2019, HHS had not provided information on actions taken to implement it. We will update its status when we receive additional information.

Recommendation: The Secretary of HHS should expeditiously develop a plan--that includes priorities, timeframes, clear roles and responsibilities, and methods for assessing progress--to effectively implement the NAS-related recommendations identified in the Protecting Our Infants Act: Final Strategy. (Recommendation 1)

Agency: Department of Health and Human Services
Status: Open
Priority recommendation

Comments: HHS concurred with this recommendation. HHS' Behavioral Health Coordinating Council finalized a plan for implementing the Strategy in 2019 . The plan includes priorities, timeframes, and clear roles and responsibilities for implementing NAS-related recommendations in the Strategy. The plan does not specifically identify methods for assessing progress on the recommendations, but HHS officials told us in November 2019 that the department holds quarterly conference calls to share updates and formal written updates will be collected at the end of each year. To close this recommendation, HHS needs to provide documentation-such as, the formal written updates-to show how the department assesses progress on the recommendations.

Recommendation: The Undersecretary for Health should take additional steps to ensure that VA's website reports health care quality measures that cover a broad range of health care services, highlights key differences in the clinical quality of care, and presents this information in an easily accessible and understandable way (Recommendation 1).

Agency: Department of Veterans Affairs
Status: Open

Comments: As of January 2020, VA provided information that they had updated information on its website to include more quality measures, particularly as they relate to outpatient care. While VA has made progress in reporting on additional measures, we reviewed VA's website-specifically, their Access and Quality webpage which is the primary webpage for veterans to access information on quality-as of February 2020 and found that VA has still yet to report on a broad range of quality measures that would assist veterans in making health care decisions for inpatient care. For example, VA does not report any quality measures related to readmissions and mortality; length-of-stay; or efficiency. VA also continues to report only one timely and effective care measure for inpatient care. With regards to presentation of its quality measures, VA no longer links its Access and Quality webpage to the homepage of VA's website, making it more difficult to find. Additionally, for the new outpatient measures that VA has added to its website, VA has not presented these measures in an easily understandable way as there is little explanation of what they are measuring and how veterans can use these measures to make healthcare decisions. We will keep this recommendation open until VA has made further updates to its website.

Recommendation: The Undersecretary for Health should direct VA Central Office to conduct a systematic assessment of the completeness and accuracy of patient clinical information across VAMCs that is used to calculate the health care quality measures VA reports and address any deficiencies that affect the accuracy of these measures (Recommendation 2).

Agency: Department of Veterans Affairs
Status: Open

Comments: As of January 2020, VA has said they have focused on three main efforts as it relates to documenting information on VA quality of care, including: timeliness of access information (e.g., wait times) to health care within VA facilities; timeliness and accuracy of payments to community care providers; and accuracy of coding and documentation within VA and from community providers. In particular, VA has conducted several efforts to improve education and training on clinical documentation and coding, particularly for providers. VA has also said it has made efforts in requiring programs across regional networks aimed at improving clinical documentation and coding. While these efforts can help with improving documentation of care to veterans, it is unclear how VA Central Office has assessed whether these efforts have actually achieved its goals and improved the accuracy of its quality measures. As we stated in our report, VA Central Office has not conducted a systematic assessment of the completeness and accuracy of the clinical data recorded in VA patient medical records across all VAMCs. The results of such a systematic analysis could help identify the deficiencies, if any, in the recording of patient clinical information and what steps, if any, VA Central Office may need to take to address them. We will keep this recommendation open until VA provides information on a systematic assessment of clinical documentation.

Recommendation: The Secretary of Energy should lead the development of a mechanism for interagency collaboration to determine roles and responsibilities for addressing priorities related to research on the health effects of low-dose radiation.

Agency: Department of Energy
Status: Open

Comments: In a July 2018 update, DOE stated that it believes that the White House Office of Science and Technology Policy's (OSTP) National Science and Technology Council (NSTC) is the appropriate entity to lead interagency collaboration and coordinate science and technology policy. According to DOE, OSTP intends to charter an interagency working group under the NSTC on a government-wide strategy related to research on the health effects of low-dose radiation. As of December 2019, OSTP had begun to address a related requirement under the American Innovation and Competitiveness Act to coordinate federal efforts related to radiation biology research and planned to release a report on this topic in early 2020. When we confirm what actions OSTP has taken to establish this working group, we will provide updated information.

Recommendation: The Under Secretary for Health should further clarify when and for what purposes each national policy and guidance document type should be used, including whether guidance documents, such as program office memos, should be vetted and recertified. (Recommendation 1)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open
Priority recommendation

Comments: VA agreed with our recommendation. In October 2019, VHA issued an interim policy on program office memos (also known as "operational memos") that described how these guidance documents should be vetted and recertified. For example, operational memos issued after VHA's new interim policy will expire 2 years after publication if no further action is taken. In November 2019, VHA further clarified in another interim policy the purpose of all national policy and guidance documents, including the purpose and audience for each document type. Because VHA interim policy, by definition, is automatically rescinded after 1 year unless incorporated into a national policy directive, VHA needs to provide us with the finalized version of its recertified national policy directive in order to fully implement this recommendation. The recertified national policy directive should include the framework outlined in its interim policy documents.

Recommendation: The Under Secretary for Health should develop standard processes for consistently maintaining and disseminating guidance documents to each level of the organization. (Recommendation 2)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open

Comments: VA agreed with our recommendation. VHA reported that it added a program office memo (also known as "operational memo") section to its internal publications website in November 2017. Uploading operational memos to this website allowed VHA to identify 327 outdated documents that it has since rescinded, as well as numerous other documents that may require rescission. In October 2019, VHA issued an interim policy requiring all operational memos to be maintained on its publications website. Because interim policy is automatically rescinded after 1 year, VHA needs to provide us with the finalized version of its recertified national policy directive that includes the process it established to maintain these documents. In addition, VHA has not provided documentation of how it will disseminate operational memos so that VHA program offices, VISNs, and VAMCs are aware of new or rescinded guidance.

Recommendation: The Under Secretary for Health should establish a mechanism by which program offices systematically obtain feedback from VISNs and VAMCs on national policy after implementation and take the appropriate actions. (Recommendation 4)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open

Comments: VA agreed with our recommendation. In June 2018, VHA reported that it had formed a Field Advisory Workgroup to provide continuing advice on national policy. VHA reported its findings and recommendations from the first workgroup meeting in December 2017 to senior leadership, and held another series of interviews in Summer 2018 to gain additional feedback about how national policy changes affect local facilities. In November 2019, VHA noted that it is developing a standardized process for collecting feedback from the field on published policies. To fully implement this recommendation, VHA should provide documentation of the mechanism by which program offices systematically obtain feedback from VISNs and VAMCs on national policy after implementation and how it will take the appropriate actions.

Recommendation: The Under Secretary for Health should establish a standard policy exemption waiver process and centrally track and monitor approved waivers. (Recommendation 5)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open

Comments: VA agreed with our recommendation. In October 2018, VHA reported that it had collected information on the waiver procedures and areas of improvement that exist at both the national and local levels. Based on this information, VHA's Waiver Workgroup was finalizing its recommendations for implementing a formal waiver process. As of November 2019, VHA had not yet reached a decision on how to proceed. To fully implement this recommendation, VHA should provide us with documentation of a process that standardizes policy exemptions waivers, including tracking and monitoring those that are approved.

Recommendation: The Under Secretary for Health should establish a standard process, including designated oversight roles, to periodically monitor that local policies established by VISNs and VAMCs align with national policies. (Recommendation 6)

Agency: Department of Veterans Affairs: Veterans Health Administration
Status: Open

Comments: VA agreed with our recommendation. In June 2018, VHA reported that it had identified approximately 55,000 local policies and included them in a SharePoint database, which will serve as a baseline for removing redundant or conflicting local policy. In November 2019, VHA issued an interim policy that established business rules for oversight and monitoring local policy development at the VISN and VAMC levels. Specifically, VHA will assess the number of local policies every 6 months as well as identify patterns of non-compliance. In addition, the interim policy includes standardized templates, a recertification requirement of 5 years to mirror the national policy requirement, and restricts VHA program offices from creating requirements for local policy development. VHA also established resources for the new interim policy, such as a list of local policies as required by national policy. Because VHA interim policy, by definition, is automatically rescinded after 1 year unless incorporated into a national policy directive, VHA needs to provide us with the finalized version of its recertified national policy directive in order to fully implement this recommendation.

Recommendation: The Commissioner of FDA should pursue formal agreements with countries exporting seafood to the United States that commit these countries to test for drugs of concern to FDA and the corresponding maximum residue levels (MRLs) that FDA established for these drugs. (Recommendation 1)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: FDA partially agreed with our recommendation. According to FDA, the agency is working on a plan to explore the viability of reaching cooperative arrangements with foreign regulatory bodies concerning imported aqua-cultured seafood. In exploring such arrangements, FDA stated that it will seek to explore a means by which the agency can leverage foreign regulatory bodies' seafood safety programs to provide additional oversight for seafood destined for the United States. According to FDA, such arrangements would be negotiated depending on the country's specific situation. We will continue to monitor FDA's specific efforts to implement this recommendation.

Recommendation: The Administrator of FSIS should require as part of an equivalence determination that countries exporting catfish to the United States include in their residue monitoring plans the drugs of concern to FSIS and the corresponding maximum residue levels. (Recommendation 3)

Agency: Department of Agriculture: Food Safety and Inspection Service
Status: Open

Comments: As of December 2019, FSIS had not yet acted on this recommendation. According to FSIS officials, the agency made a request to the USDA Office of General Counsel for their opinion on the legality of the recommendation. FSIS is waiting for OGC's response to that request. FSIS maintains that the information submitted by foreign countries as part of the equivalence determination that outlines their chemical residue monitoring plans and the review by the FSIS equivalence staff to ensure these countries employ an equivalent level of public health protection as that of the US already addresses this recommendation. We will continue to monitor how FSIS addresses this recommendation.

Recommendation: The Commissioner of FDA should coordinate and communicate with FSIS in developing drug residue testing methods and corresponding maximum residue levels for imported seafood that may also be applicable to imported catfish. (Recommendation 4)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open
Priority recommendation

Comments: FDA agreed with this recommendation. According to FDA officials, the agency shared its testing methods for two drugs with FSIS and as of as of April 2019, FSIS and FDA were using the same method for measuring and confirming these two unapproved drugs. In August 2020, FDA told GAO that the agencies convene quarterly to discuss emerging and ongoing research needs in laboratory method development and the establishment of drug residue limits in seafood. We commend FDA and FSIS for taking these steps to share information on testing methods. However, GAO found that the agencies continue to use different multi-residue testing methods that look for different numbers of drugs--99 for FSIS and 40 for FDA--which results in the agencies using different maximum residue levels for some drugs. FDA's method can detect drugs that FSIS's does not and can detect some drugs at lower levels. FSIS's multi-residue method can detect 59 more drugs than FDA's method. The agencies do not have any plans to work on a multi-residue method both agencies can use.

Recommendation: The Administrator of FSIS should coordinate and communicate with FDA in developing drug residue testing methods and corresponding maximum residue levels for imported catfish that may also be applicable to other imported seafood. (Recommendation 5)

Agency: Department of Agriculture: Food Safety and Inspection Service
Status: Open
Priority recommendation

Comments: According to FSIS officials in May 2020, the agency coordinates with FDA and EPA to carry out the National Residue Program, which entails testing FSIS-regulated products, including catfish, for chemical compounds of public health concern. FSIS officials indicated that FSIS will continue to use its own test methods that meet the agency's pre-defined quality assurance criteria, are applicable to the particular commodity under its jurisdiction, and fit its business model. Thus, FSIS currently does not have plans to work on a multi-residue method that both it and FDA can use on imported seafood, including catfish, as we have recommended.

Recommendation: To ensure progress is made toward the implementation of any IT enhancements needed to establish electronic public health situational awareness network capabilities mandated by PAHPRA, the Secretary of HHS should direct the Assistant Secretary for Preparedness and Response to task an integrated project team, made up of an IT project manager and business owner, with including specific actions in the Public Health and Medical Situational Awareness Strategy Implementation Plan for conducting all activities required to establish and operate the network.

Agency: Department of Health and Human Services
Status: Open

Comments: Officials have previously acknowledged that a public health situational awareness network capability is important for identifying, processing, and comprehending data in real-time and stated that such a capability requires coordination and participation from numerous federal entities, including numerous HHS's operating divisions. However, as of January 2020, GAO has not received any information demonstrating progress made to implement our recommendation. Further, HHS has not provided us with a plan of action describing how they would implement the recommendation. Until steps are taken to implement our recommendation, HHS may not make the progress needed to establish an electronic public health situational awareness network capability mandated by PAHPRA in 2013 and the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019.

Recommendation: To ensure progress is made toward the implementation of any IT enhancements needed to establish electronic public health situational awareness network capabilities mandated by PAHPRA, the Secretary of HHS should direct the Assistant Secretary for Preparedness and Response to task the integrated project team with developing a project management plan that includes measurable steps--including a timeline of tasks, resource requirements, estimates of costs, and performance metrics--that can be used to guide and monitor HHS's actions to establish the network defined in the plans.

Agency: Department of Health and Human Services
Status: Open

Comments: Officials have previously acknowledged that a public health situational awareness network capability is important for identifying, processing, and comprehending data in real-time and stated that such a capability requires coordination and participation from numerous federal entities, including numerous HHS's operating divisions. However, as of February 2020 agency officials have not indicated whether or not they concur with the recommendation, nor have they taken any action or provided a plan of action describing how they would implement the recommendation. Until steps are taken to implement our recommendation, HHS may not make progress toward establishing an electronic public health situational awareness network capability mandated by PAHPRA in 2013 and in the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 .

Recommendation: To ensure progress is made toward the implementation of any IT enhancements needed to establish electronic public health situational awareness network capabilities mandated by PAHPRA, the Secretary of HHS should direct the Assistant Secretary for Preparedness and Response to conduct all IT management and oversight processes related to the establishment of the network in accordance with Enterprise Performance Life Cycle Framework guidance, under the leadership of the HHS CIO.

Agency: Department of Health and Human Services
Status: Open
Priority recommendation

Comments: In HHS' Public Health and Social Services Emergency Fund's fiscal year 2021 budget justification-which includes the Office of the Assistant Secretary for Preparedness and Response-the agency stated it "concurred" with this recommendation. However, as of February 2020, GAO has not received any information demonstrating progress made to implement our recommendation. Until then, HHS may continue to lack the necessary progress needed in order to establish an electronic public health situational awareness network capability mandated by PAHPRA. To address this recommendation, HHS needs to direct the Assistant Secretary for Preparedness and Response to conduct all IT management and oversight processes related to the establishment of the network in accordance with Enterprise Performance Life Cycle Framework guidance.

Recommendation: The Secretary of Health and Human Services should direct the Administrator of the Centers for Medicare & Medicaid Services to take steps to ensure that state-based marketplace annual sustainability plans, to the extent possible, have complete 5-year budget forecasts. (Recommendation 1)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS did not concur with our recommendation and stated that it had updated its requirement to request 2-year budget forecasts instead of 5-year budget forecasts. In its December 2017 statement of actions, HHS stated that it was working to streamline and simplify its data collection effort as part of the annual sustainability plan. In April 2018, HHS provided a revised 2-year budget forecast template as well as related state marketplace training documentation. As of April 2020, HHS had not provided further documented evidence of its streamlined process using the 2-year budget forecast template or justification that a 5-year budget is not necessary for assessing long-term financial sustainability and state marketplace sustainability risks.

Recommendation: The Secretary of Health and Human Services should direct the Administrator of the Centers for Medicare & Medicaid Services to take steps to ensure that all state-based marketplaces provide required annual financial audit reports which are in accordance with generally accepted government auditing standards. (Recommendation 2)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS concurred with our recommendation and stated in its December 2017 update that it continued to provide technical assistance such as webinars and other trainings on independent financial and programmatic audit submission requirements. In April 2018, HHS provided evidence that it had taken some steps to ensure that state-based marketplaces provide required annual financial audit reports, including draft financial audit procedures, documentation of related training provided to states, and a revised HHS state officer annual review checklist emphasizing financial audit reporting. However as of April 2020, the department had not provided evidence of finalized procedures, examples of checklist usage, or of states providing annual financial audit reports. Further, HHS training documentation stated that state-based marketplaces could provide alternate financial audit reports, such as a state-wide financial audit report, in lieu of a marketplace specific report. It is not clear from the provided evidence that the department has ensured that state-based marketplaces are in compliance with financial audit reporting requirements. We will continue to monitor the department's progress in implementing the recommendation and provide updates when the agency takes further action.

Recommendation: The Secretary of Health and Human Services should direct the Administrator of the Centers for Medicare & Medicaid Services to take steps to ensure that marketplace IT self-sustainability risk assessments are based on fully defined measurable terms, a clear categorization process, and a defined response to high risks. (Recommendation 3)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS concurred with our recommendation and stated in its December 2017 update that it would refine its marketplace self-sustainability risk assessment process to provide greater insight into the state marketplace sustainability efforts and to identify areas where states may need assistance. In April 2018, HHS provided evidence that it had taken some steps to base its risk assessments on fully defined processes. CMS provided documentation of clearly defined and measurable terms used for state marketplace budget analysis. However, HHS did not provide evidence that these defined terms were incorporated into analyses or risk assessments. As of April 2020, CMS has not provided evidence that it took steps to develop a clear categorization process or a defined response to high risks. We will continue to monitor the department's progress in implementing the recommendation and provide updates when the agency takes action.

Recommendation: The Secretary of Health and Human Services should direct the Administrator of the Centers for Medicare & Medicaid Services to take steps to ensure that states develop, update, and follow performance measurement plans that allow the states to continuously identify and assess the most important IT metrics for their state marketplaces. (Recommendation 4)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS partially concurred with our recommendation and stated in its December 2017 update that though each marketplace was accountable for managing and reporting its own IT metrics in accordance with federal and state law, HHS would work with states on the improvement of their management and operations through technical assistance and oversight and accountability measures. As of April 2020, the agency had not yet provided sufficient evidence that it has implemented the recommendation. We will continue to monitor the department's progress in implementing the recommendation and provide updates when the agency takes action.

Recommendation: The Secretary of Health and Human Services should direct the Administrator of the Centers for Medicare & Medicaid Services to take steps to conduct operational analysis reviews and systematically monitor the performance of states' marketplace IT systems using key performance indicators. (Recommendation 5)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS did not concur with our recommendation and stated that it conducted Open Enrollment Readiness Reviews to assess marketplace key performance indicators, which according to CMS officials, are similar to operational analysis reviews. However, as of October 2018, HHS had not provided evidence that the Open Enrollment Readiness Reviewed systematically and comprehensively reported on the key performance indicators or include discussion of other key elements identified in best practices for operational analysis reviews, such as how objectives could be better met, or costs could be saved. As of April 2020, the agency had not yet provided sufficient evidence that it has implemented the recommendation.

Recommendation: The Secretary of Health and Human Services should direct the Administrator of the Centers for Medicare & Medicaid Services to take steps to ensure that metrics collected from states to monitor marketplaces' operational performance link to performance goals and include baselines and targets to monitor progress. (Recommendation 6)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS partially concurred with our recommendation and stated in its December 2017 update that states were responsible for monitoring their own performance measures but HHS would continue to review IT metrics of state marketplaces in the implementation phase of their systems through technical assistance activities and oversight and accountability measures. As of April 2020, the agency had not yet provided sufficient evidence that it has implemented the recommendation. We will continue to monitor the department's progress in implementing the recommendation and provide updates when the agency takes action.

Recommendation: To improve CMS's oversight of states' MLTSS programs, the Administrator of CMS should take steps to identify and obtain key information needed to oversee states' efforts to monitor beneficiary access to quality services, including, at a minimum, obtaining information specific to network adequacy, critical incidents, and appeals and grievances.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: The Department of Health and Human Services (HHS) agreed with this recommendation. In December 2017, HHS communicated its intent to review regulations and enhance its capacity to measure, monitor, and improve care and quality across a number of domains, including MLTSS. As of February 2020, HHS stated that it is developing guidance related to reporting on key information needed to oversee beneficiary access to care. GAO will continue to monitor the department's actions and any steps taken to address this recommendation.

Recommendation: To increase transparency and obtain information to better inform decisions on whether to investigate potentially unfair or deceptive practices in the air ambulance industry, the Secretary of Transportation should assess available federal and industry data and determine what further information could assist in the evaluation of future complaints or concerns regarding unfair or deceptive practices.

Agency: Department of Transportation
Status: Open
Priority recommendation

Comments: The FAA Reauthorization Act of 2018 (the Act), signed into law on October 5, 2018, directed the establishment of an Air Ambulance and Patient Billing (AAPB) Advisory Committee. The Act also required the committee to make recommendations on a variety of topics, including what additional data from air ambulance providers and other sources should be collected by DOT to improve its understanding of the industry. On September 12, 2019, DOT announced the formation of the AAPB Advisory Committee, including the appointment of 13 members. The first meeting of the AAPB Advisory Committee was held in January 2020. Soon after this meeting, three subcommittees were established, including one on Disclosure and Distinction of Charges and Coverage for Air Ambulance Services and another on Prevention of Balance Billing. Subcommittee meetings began in March 2020, although given the impact of COVID-19, the subcommittee meets scheduled for April and May 2020 were postponed. Pursuant to the Act, the AAPB Advisory Committee is to submit a report containing its recommendations not later than 180 days after the date of its first meeting. GAO will continue to monitor the work of the AAPB Advisory Committee related to this recommendation.

Recommendation: To increase transparency and obtain information to better inform decisions on whether to investigate potentially unfair or deceptive practices in the air ambulance industry, the Secretary of Transportation should consider consumer disclosure requirements for air ambulance providers, which could include information such as established prices charged, business model and entity that establishes prices, and extent of contracting with insurance.

Agency: Department of Transportation
Status: Open

Comments: The FAA Reauthorization Act of 2018 (the Act), signed into law on October 5, 2018, directed the establishment of an Air Ambulance and Patient Billing (AAPB) Advisory Committee. The Act also required the committee to make recommendations on a variety of topics, including the recommendations from this GAO report. On September 12, 2019, DOT announced the formation of the AAPB Advisory Committee, including the appointment of 13 members. The first meeting of the AAPB Advisory Committee was held in January 2020. Soon after this meeting, three subcommittees were established, including one on Disclosure and Distinction of Charges and Coverage for Air Ambulance Services and another on Prevention of Balance Billing. Subcommittee meetings began in March 2020, although given the impact of COVID-19, the subcommittee meets scheduled for April and May 2020 were postponed. Pursuant to the Act, the AAPB Advisory Committee is to submit a report containing its recommendations not later than 180 days after the date of its first meeting. GAO will continue to monitor the work of the AAPB Advisory Committee related to this recommendation.

Recommendation: The Administrator of CMS should evaluate the possible costs and savings of using disposable devices that could potentially substitute for DME, including options for benefit categories and payment methodologies that could be used to cover these substitutes, and, if appropriate, seek legislative authority to cover these devices.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: In March 2019, HHS included in its fiscal year 2020 budget a legislative proposal to extend Medicare coverage to disposable devices that could potentially substitute for DME in treating and managing diabetes. As of March 2020, CMS has not provided documentation of the evaluation of possible costs and savings that we recommended and that we believe underpins the legislative proposal. We will review this documentation once provided.

Recommendation: To improve annual reporting on PTC improper payments, control activities related to eligibility determinations, and calculations of advance PTC, the Secretary of Health and Human Services should direct the Administrator of CMS to annually report improper payment estimates and error rates for the advance PTC program.

Agency: Department of Health and Human Services
Status: Open
Priority recommendation

Comments: The Department of Health and Human Services (HHS) concurred with this recommendation. On May 23, 2018, HHS's Centers for Medicare and Medicaid Services (CMS) stated that it is currently in the process of developing an improper payment measurement for the advance premium tax credit (PTC). The development of the measurement methodologies will be a multi-year process which consists of the development of measurement policies, procedures, and tools. It also includes extensive pilot testing to ensure an accurate and efficient improper payment estimate, as well as, acquisition activities for procurement of improper payment measurement contractors. In January 2020, CMS stated that it is still in the process of developing an improper payment measurement for the advance PTC. Further, CMS stated that it provided progress updates in the fiscal year 2019 HHS agency financial report (AFR), and will continue to do so in future AFRs until an improper payment rate is estimated. We will continue to monitor the agency's actions to address this recommendation.

Recommendation: To improve annual reporting on PTC improper payments, control activities related to eligibility determinations, and calculations of advance PTC, and until annual reporting of improper payment estimates and error rates for the advance PTC program is performed, the Secretary of Health and Human Services should direct the Administrator of CMS to disclose significant matters relating to the Improper Payments Information Act (IPIA) estimation, compliance, and reporting objectives for the advance PTC program in the agency financial report, including CMS's progress and timeline for expediting the achievement of those objectives and the basis for any delays in meeting IPIA requirements.

Agency: Department of Health and Human Services
Status: Open

Comments: HHS concurred with this recommendation. On February 28, 2018, the Department of Health and Human Services's (HHS) Centers for Medicare and Medicaid Services (CMS) stated that updates on the advance premium tax credit (PTC) program improper payment measurement development were provided in the fiscal year (FY) 2017 Agency Financial Report (AFR), which was published in November 2017. In FY 2018, we reviewed the FY 2017 AFR that HHS's CMS cited in support for closing this recommendation. Based on our review, the FY 2017 AFR does not address our recommendation as it does not provide a timeline for reporting an improper payment estimate. In FY 2019, we reviewed HHS's FY 2018 AFR published in November 2018, which includes a statement that HHS will continue to update its annual AFRs on the status of the measurement program development until the improper payment estimate is reported. However, this latest AFR also does not provide a timeline for reporting an improper payment estimate for HHS's PTC program. In January 2020, CMS stated that it is in the process of procuring federal contractors to perform the improper payment measurement. However, CMS further stated that due to uncertainties surrounding the timing of the procurement, CMS does not anticipate publishing a reporting timeline until the contracts have been awarded. We will continue to monitor the agency's actions to address this recommendation.

Recommendation: To improve annual reporting on PTC improper payments, control activities related to eligibility determinations, and calculations of advance PTC, the Secretary of Health and Human Services should direct the Administrator of CMS to design and implement procedures for verifying the identities of phone and mail applicants to reasonably assure that ineligible individuals are not enrolled in qualified health plans in the marketplaces or provided advance PTC.

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services (HHS) neither agreed nor disagreed with this recommendation. Regarding verification of filer identity, HHS stated, in response to the draft report, that for individuals starting an application via phone, the call center representatives use verbal attestations for verifications from individuals. HHS stated that for paper applications, individuals must provide names and complete addresses as well as other information. In addition, HHS stated that individuals must attest that the information they provide on all applications is accurate by signing under penalty of perjury. However, these steps do not involve the verification of an applicant's identity to a third-party source. In August 2018, HHS officials stated that they are exploring alternatives for assessing risk and ensuring integrity of applicant information that is provided to the program and ways to ensure personal information provided by an individual is accurate through a variety of means. After this analysis phase, they will assess resource requirements, cost, and operational implications for potential implementation approaches with a target date for completion of 2019. As of December 2018, HHS had not designed and implemented procedures for verifying the identities of phone and mail applicants, as GAO recommended. As of January 2020, HHS indicated that it is developing new policy and guidance which could significantly change potential solutions or requirements. However, HHS did not provide us a time frame for when it plans to finalize the new policy and guidance. We will continue to monitor agency's actions to address the recommendation.

Recommendation: To comply with improper payments reporting requirements and improve procedures related to processing PTC information on tax returns, the Commissioner of Internal Revenue should direct the appropriate officials to assess the program against applicable IPIA-defined thresholds and conclude on its susceptibility to significant improper payments, and revise the scope of its improper payments susceptibility assessment for the PTC program to include instances in which advance PTC is greater than or equal to the amount of PTC claimed on the tax return. If the program meets the IPIA definition for being susceptible to significant improper payments based on this assessment, estimate and report improper payments associated with the PTC program consistent with IPIA requirements.

Agency: Department of the Treasury: Internal Revenue Service
Status: Open
Priority recommendation

Comments: The Internal Revenue Service (IRS) partially agreed with this recommendation. On December 13, 2019, IRS provided us a status update and stated that its Research, Applied Analytics and Statistics division completed an analysis of net premium tax credit (PTC) using National Research Program (NRP) tax years 2015 and 2014 data during the 4th quarter of fiscal year 2019 and developed improper payment estimates using two different methodological approaches. However, IRS indicated that it did not publish these improper payment estimates in Treasury's Agency Financial Report for two reasons: (1) there is as yet insufficient NRP data to develop an estimate that is within the confidence interval and margin of error prescribed by the Office of Management and Budget for improper payments sampling, and (2) the Department of the Treasury (Treasury) wishes to engage with Health and Human Services' Centers for Medicare & Medicaid Services on the potential for developing a joint rate estimate for advance PTC and PTC. In addition, IRS noted that it had not yet determined whether this is even possible from a data compatibility standpoint. Further, IRS stated that while the estimates do not meet the statistical precision requirement, they do suggest that Net PTC would meet the criteria to be considered susceptible to significant improper payments. IRS indicated that when it last discussed this recommendation with GAO, it was suggested this recommendation would be closed once improper payment rates are published. However, IRS would now like GAO to consider closing this recommendation at this time given (1) the IRS's efforts to analyze potential improper payments, (2) Treasury's new approach to reporting, and (3) the need for additional years of data before a statistically valid estimate can be developed. We do not believe the recommendation should be closed at this time based on the three reasons IRS has listed above. However, we credit IRS for exploring ways to meet the intent of the recommendation. We will continue to monitor the agency's actions to address this recommendation.

Recommendation: To comply with improper payments reporting requirements and improve procedures related to processing PTC information on tax returns, the Commissioner of Internal Revenue should direct the appropriate officials to assess and document the feasibility of approaches for incorporating information from the marketplaces on individuals who did not demonstrate that they met the eligibility requirements for citizenship or lawful presence in the tax compliance process. If determined feasible, IRS should work with Treasury to require marketplaces to periodically provide such information on individuals and use such information to recover advance PTC made for those individuals.

Agency: Department of the Treasury: Internal Revenue Service
Status: Open

Comments: The Internal Revenue Service (IRS) agreed with this recommendation. In December 2018, an IRS official indicated that IRS conducted a detailed review of the recommendation. IRS informed GAO that it is internally discussing an alternative way to address the recommendation to prevent premium tax credit to noncitizens. The IRS official indicated that IRS is reviewing this alternative with the Department of the Treasury and the Department of Health and Human Services' Centers for Medicare & Medicaid Services. IRS did not provide GAO with a time frame for its implementation. On December 13, 2019, IRS provided us a status update and stated that it had no new information for this recommendation. We will continue to monitor the agency's actions to address this recommendation.

Recommendation: To ensure that the HVBP program accomplishes its goal to balance quality and efficiency and to ensure that it minimizes the payment of bonuses to hospitals with lower quality scores, the Administrator of CMS should revise the formula for the calculation of hospitals' total performance score or take other actions so that the efficiency score does not have a disproportionate effect on the total performance score.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS indicated that it would examine the formula used for calculating hospitals' total performance scores and consider revisions, which would be subject to notice and comment rulemaking. In September 2018, HHS indicated that it had been examining alternatives and considering revising the formula for the calculation of hospitals' total performance scores (TPS) consistent with relevant statutory guidance, and in a way to reduce the effect of the efficiency domain on the TPS. In the Fiscal Year 2019 Inpatient Prospective Payment System proposed rule, CMS proposed to remove the safety domain weighted at 25 percent of the TPS and, in connection, increase the weight of the clinical care domain from 25 percent to 50 percent, which was estimated to reduce the effect of the efficiency domain on the TPS. According to CMS, stakeholders were concerned about the safety domain removal and adverse impacts to rural and smaller hospitals due to increasing outcome measure relative weights. CMS indicated that it analyzed current data in the fall of 2018 and found a similar trend, where rural and small hospitals' payment would be adversely impacted from increasing outcome measure weights. CMS decided to keep measure weights to avoid adversely impacting rural and small hospitals. However, CMS did not take actions so that the efficiency score would not have a disproportionate effect on the total performance score and bonus payments to hospitals with lower quality scores. As of January 2020, the recommendation remains open.

Recommendation: To ensure that the HVBP program accomplishes its goal to balance quality and efficiency and to ensure that it minimizes the payment of bonuses to hospitals with lower quality scores, the Administrator of CMS should revise the practice of proportional redistribution used to correct for missing domain scores so that it no longer facilitates the awarding of bonuses to hospitals with lower quality scores.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS indicated that it would explore alternatives to the practice of proportional redistribution, and any changes to the distribution of weights for missing domains would be evaluated for potential negative impacts and would be subject to notice and comment rulemaking. In September 2018, HHS indicated that it was exploring alternatives and considering revising the practice of proportional redistribution used to correct for missing domain scores while also being mindful of any potential unintended consequences. In the Fiscal Year 2019 Inpatient Prospective Payment System proposed rule, CMS proposed to remove the safety domain and, in connection, to require scores for the remaining three domains in order to calculate the total performance score, but CMS did not finalize the weighting revision. CMS reported that stakeholders were concerned about the safety domain removal and any adverse impact to rural and smaller hospitals due to increasing outcome measure relative weights. CMS reported that it analyzed data and found that rural and small hospitals' payment would be adversely impacted from changing proportional redistribution to assign greater relative weight to outcomes. As a result, CMS decided to keep proportional redistribution. However, CMS's actions did not revise the practice of proportional redistribution, and, as a result, the practice may continue to facilitate the awarding of bonuses to hospitals with lower quality scores. As of January 2020, the recommendation remains open.

Recommendation: To better understand the available opportunities for collecting inmate health care utilization data, BOP should conduct a cost-effectiveness analysis of potential solutions, and take steps toward implementation of the most effective solution.

Agency: Department of Justice: Bureau of Prisons
Status: Open

Comments: BOP agreed with GAO's June 2017 recommendation and has begun to take steps to address it. In 2018, BOP contracted with a management consulting firm to improve organizational alignment and strengthen data analytics capabilities. This firm is also examining data analytics solutions and by late March 2020 is expected to make recommendations to BOP to support a request for purchase (RFP) for the most cost-effective one. BOP anticipates the RFP will then follow within the subsequent three months. This contracting work is a positive step that should help BOP identify the most cost-effective solution to collect health care utilization data. BOP is still in the early stages of implementing this action, therefore it is too soon to assess whether its efforts will fully address GAO's recommendation. However, once these actions are completed, BOP could be better positioned to find a solution for collecting the needed data.

Recommendation: To better understand the available opportunities for controlling health care costs, BOP should implement its guidance to conduct "spend analyses" of BOP's health care spending, using data sources already available

Agency: Department of Justice: Bureau of Prisons
Status: Open

Comments: BOP agreed with GAO's June 2017 recommendation and has begun to take steps to address it. In 2018, BOP contracted with a management consulting firm to identify opportunities to improve organizational alignment and strengthen data analytics capabilities. As part of this effort, BOP also contracted with a health care finance expert, who began working with BOP Health Services Division in June 2019. The expert has met with subject matter experts across disciplines to identify reliable sources for medical cost data, including medical activities data, staffing data, and medical cost data to support conducting spend analyses. BOP expects this effort to be completed by late spring 2020. This contracting work is a positive step toward implementing BOP's spend analysis guidance; however, since BOP has not yet completed this effort, it is too soon to assess whether BOP's efforts will fully address GAO's recommendation. Once BOP has completed this effort, it could be better positioned to identify opportunities for controlling health care costs.

Recommendation: To determine the actual or likely effectiveness of its ongoing or planned health care cost control initiatives, BOP should evaluate the extent to which its initiatives achieve their cost control aim.

Agency: Department of Justice: Bureau of Prisons
Status: Open

Comments: BOP agreed with GAO's June 2017 recommendation and has begun to take steps to address it. In 2018, BOP contracted with a management consulting firm to identify opportunities to improve organizational alignment and strengthen data analytics capabilities. As part of this effort, BOP also contracted with a health care finance expert, who began working with BOP Health Services Division in June 2019. BOP is working with this expert to validate existing financial data sources and apply a standardized cost accounting model to evaluate the cost effectiveness of key health care cost control initiatives. According to BOP, the model is being developed in phases with the initial phase expected to be completed by late March 2020. The second phase of the model is scheduled to launch in October 2020. This is a positive step that will better position BOP to evaluate its health care cost control initiations. Since BOP has not yet completed this effort, it is therefore too soon to assess whether its efforts will fully address GAO's recommendation. However, once BOP has completed this effort, it could help BOP evaluate the effectiveness of its health care cost control initiatives.

Recommendation: To enhance its strategic planning for and implementation of health care cost control efforts, BOP should incorporate elements of a sound planning approach and (1) establish a means of measuring progress toward and effectiveness of its activities for its current strategic objectives and goals related to controlling health care costs; and (2) identify the resources and investments necessary for implementation of its planned health care cost control initiatives.

Agency: Department of Justice: Bureau of Prisons
Status: Open

Comments: BOP agreed with GAO's June 2017 recommendation and has begun to take steps to address it. In October 2018, BOP initiated a contract with an external group of public administration experts to examine BOP's organizational structure and its lines of authority. The group completed its study and issued a report in October 2019, which included recommendations for BOP. According to BOP, the Health Services Division is in the process of creating a Strategic Plan Advisory Group, which will implement recommendations in the October 2019 report, and will establish a 2020-2025 Strategic Plan. The Strategic Plan Advisory Group will also evaluate metrics, including those related to financial performance that will, according to BOP, enable it to identify the resources and investments to help control health care costs. This action is a positive step that could help BOP enhance its strategic planning for and implementation of health care cost control efforts. However, BOP is in the early stages of implementing this recommendation; thus it is too soon to assess if BOP will find the most effective method for enhancing its strategic planning.

Recommendation: To improve the reliability and utility of its Federal Medical Center mission analyses, BOP should document the analyses and findings that underlie its recommendations.

Agency: Department of Justice: Bureau of Prisons
Status: Open

Comments: In June 2017, BOP agreed with GAO's recommendation. However, BOP decided to end the Federal Medical Center mission analyses process. Instead, in September 2018 BOP established a Medical Referral Center (MRC) Executive Advisory Board, made up of BOP's Health Services Division leadership and wardens from all seven MRCs. According to BOP, the Board plans to develop and implement dashboard metrics by the end of calendar year 2020 to monitor essential functions at the centers, which it hopes will improve management of the inmate health care system. In the meantime, BOP reports that the Board has already developed and implemented the MRC pipeline patient dashboard, which permits the MRC wardens to monitor incoming patients in advance of arrival and to maximize the best patient care and housing until treatment is complete. In addition, the Board has developed and implemented the Memory Disorder Unit at one if its MRCs. This resulted in BOP making more efficient use its inpatient beds, as inmates that were housed in community hospitals could return to a BOP inpatient setting. While these steps might not fulfill the recommendation as worded, they have already resulted in some improvements to the utility of the MRCs, and therefore the intent of the recommendation. We will continue to monitor progress on this effort to ensure BOP develops and implements the metrics as planned.

Recommendation: The Secretary of Health and Human Services should direct the Commissioner of the Food and Drug Administration to require manufacturers to list the identity of comparator assays on their diagnostic test labels.

Agency: Department of Health and Human Services
Status: Open

Comments: In August 2017, officials from the Department of Health and Human Services told us that the Food and Drug Administration plans to recommend to sponsors of Zika virus diagnostic tests that they provide a description of the comparator assay. When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: To increase its assurance that PTSD and TBI are appropriately considered prior to separating certain servicemembers from the military for misconduct, the Secretary of Defense should direct the Air Force and Navy to address inconsistencies with DOD policy in their policies related to training servicemembers, including officers, on how to identify mild TBI symptoms in the deployed setting.

Agency: Department of Defense
Status: Open

Comments: At the time of report publication DOD indicated it did not concur with this recommendation. However after publication, the department indicated it concurred with the recommendation. As of September 2020, DOD is continuing to take actions to address this recommendation. When actions have been completed, GAO will update the status of the recommendation.

Recommendation: To increase its assurance that PTSD and TBI are appropriately considered prior to separating certain servicemembers from the military for misconduct, the Secretary of Defense should ensure that the military services routinely monitor adherence to policies related to screening certain servicemembers for PTSD and TBI prior to separation for misconduct.

Agency: Department of Defense
Status: Open

Comments: DOD concurred with this recommendation. As of July 2018, the department indicated that it was addressing the recommendation by requiring the military services to submit a report in March 2018 and March 2019 on how they are monitoring adherence to policies related to screening certain servicemembers for PTSD and TBI prior to separation for misconduct. In August 2020, the department indicated it completed a cycle of compliance reporting by the military services in April 2020. DOD stated it would conduct a final compliance reporting cycle in March 2021. GAO maintains that monitoring of compliance on a routine basis (i.e., ongoing) is necessary and will keep the recommendation open until the department indicates that routine monitoring will occur.

Recommendation: To increase its assurance that PTSD and TBI are appropriately considered prior to separating certain servicemembers from the military for misconduct, the Secretary of Defense should ensure that the military services routinely monitor adherence to policies related to training servicemembers, including officers, on how to identify mild TBI symptoms in the deployed setting.

Agency: Department of Defense
Status: Open

Comments: DOD concurred with this recommendation. As of September 2020, the department is continuing to take actions to address this recommendation. When actions have been completed, GAO will update the status of the recommendation.

Recommendation: To increase its assurance that PTSD and TBI are appropriately considered prior to separating certain servicemembers from the military for misconduct, the Secretary of Defense should ensure that the military services routinely monitor adherence to policies related to counseling about VA benefits and services during the process of separating certain servicemembers for misconduct.

Agency: Department of Defense
Status: Open

Comments: DOD concurred with this recommendation. As of July 2018, the department indicated that it was addressing the recommendation by requiring the military services to submit a report in March 2018 and March 2019 on how they are monitoring adherence to policies related to counseling about VA benefits and services during the process of separating certain servicemembers for misconduct. In August 2020, the department indicated it completed a cycle of compliance reporting by the military services in April 2020. DOD stated it would conduct a final compliance reporting cycle in March 2021. GAO maintains that monitoring of compliance on a routine basis (i.e., ongoing) is necessary and will keep the recommendation open until the department indicates that routine monitoring will occur.

Recommendation: To improve consistency in CMS oversight of federal spending under section 1115 demonstrations, the Secretary of Health and Human Services should require the Administrator of CMS to develop and document standard operating procedures for monitoring spending under demonstrations that (1) require setting reporting requirements for states that provide CMS the data elements needed for CMS to assess compliance with demonstration spending limits; (2) require consistent enforcement of states' compliance with financial reporting requirements; and (3) require consistent tracking of the amount of unspent funds under demonstration spending limits.

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services (HHS) has taken steps to improve the consistency of oversight of federal spending under section 1115 demonstrations. In November 2018, HHS officials reported that they have developed draft guidance, including a standard reporting tool for states, to better ensure consistent reporting of the elements needed to assess compliance with demonstration spending limits and was in the process of testing the tool with two states. In addition, the agency is developing standard operating procedures for agency staff to require consistent tracking of unspent funds under the spending limit. As of November 2019, HHS has not provided any updates. GAO will continue to monitor HHS's actions and once procedures are in place, GAO will assess whether they address our recommendation.

Recommendation: To help ensure that its efforts to increase patients' electronic access to health information are successful, the Secretary of HHS should direct ONC to use the information these performance measures provide to make program adjustments, as appropriate. Such actions may include, for example, assessing the status of program operations or identifying areas that need improvement in order to help achieve program goals related to increasing patients' ability to access their health information electronically.

Agency: Department of Health and Human Services
Status: Open

Comments: As of May 2019, ONC is collecting and evaluating information from national surveys, program data, and third-party data sources. As ONC works to implement its evaluations, it should identify how evidence collected from national surveys, program data and third-party data sources has been used to assess the outcomes of key efforts and adjust programs accordingly.

Recommendation: In order for drug sponsors to benefit from FDA's revised guidance on antibiotic development and take full advantage of the QIDP designation, FDA should develop and make available written guidance on the QIDP designation that includes information about the process a drug sponsor must undertake to request the fast track designation and how the agency is applying the market exclusivity incentive.

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: According to HHS, FDA issued draft guidance (a document of frequently asked questions) in January of 2018 that describes the QIDP designation. However, this document is in draft form and has not yet been finalized. As of August 2020, FDA reported it is working to finalize this guidance this year. GAO will revisit this recommendation when the final guidance is issued.

Recommendation: The Secretary of Defense should direct the Under Secretary of Defense for Personnel and Readiness to incorporate medical screening questions specific to gambling disorder as part of a systematic screening process across DOD, such as DOD's annual Periodic Health Assessment, for behavioral and mental-health issues.

Agency: Department of Defense
Status: Open

Comments: DOD non-concurred with this recommendation. However, the FY 2019 National Defense Authorization Act mandated that DOD implement this recommendation. As of August 2019, DOD had modified the Health Related Behaviors Survey (HRBS) to include questions on gambling and DOD and the Services are in the process of updating the electronic Periodic Health Assessment (PHA) assessment forms to capture the gambling screening data required by the legislation. Once the PHA is updated to include the gambling screening data, we will be able to close this recommendation.

Recommendation: The Secretary of Defense should direct the Under Secretary of Defense for Personnel and Readiness to update DOD Instruction 1010.04, Problematic Substance Use by DOD Personnel, to explicitly include gambling disorder as defined in the 2013 Diagnostic and Statistical Manual of Mental Disorders.

Agency: Department of Defense
Status: Open

Comments: DOD concurred with this recommendation. As of August 2019, DOD stated that this guidance is still in internal DOD coordination. Moreover, guidance related to gambling disorder screening, referral, and treatment needs to be coordinated with the Addictive Substance Misuse Advisory Committee (ASMAC) before issuance, which is anticipated to be July 2020.

Recommendation: The Secretary of Defense should direct the Secretary of the Army to update Army Regulation 600-85, The Army Substance Abuse Program, to explicitly include gambling disorder.

Agency: Department of Defense
Status: Open

Comments: DOD concurred with this recommendation. As of August 2019, the Army did not have any updates to provide on the status of this recommendation.

Recommendation: The Secretary of Defense should direct the Secretary of the Navy to update Naval Operations Instruction 5350.4D, Navy Alcohol and Drug Abuse Prevention and Control, to explicitly include gambling disorder.

Agency: Department of Defense
Status: Open

Comments: DOD concurred with this recommendation. As of August 2019, Navy officials stated that the draft Navy instruction was returned back to the Navy's Drug Detection and Deterrence Program Office to add language regarding the Secretary of the Navy's ban on hemp/CBD products that was announced this month. The Navy has added the language and pushed the instruction out to the main stakeholders for coordination. It is due back to the Director, Navy Staff no later than 30 August 2019 where it will go back into the queue for signature. Navy officials anticipate signature sometime later this fall.

Recommendation: The Commandant of the Coast Guard should update Commandant Instruction M6000.1F, Coast Guard Medical Manual, to classify gambling disorder as an addiction and not as an impulse control issue.

Agency: Department of Homeland Security: United States Coast Guard
Status: Open

Comments: The U.S. Coast Guard/DHS concurred with this recommendation. As of August 2019, the Coast Guard stated that updates to this manual are ongoing. According to Coast Guard officials, including gambling disorder in this manual is one of many significant updates the program is adjudicating for this manual and it's a lengthy clearance process. No timeline was provided for expected issuance.

Recommendation: To improve efforts to promote EHR use and electronic exchange of health information in post-acute care settings, the Secretary of Health and Human Services should direct CMS and ONC to comprehensively plan for how to achieve the department's goal related to the use of EHRs and electronic information exchange in post-acute care settings. This planning may include, for example, identifying specific actions related to post-acute care settings and identifying and considering external factors.

Agency: Department of Health and Human Services
Status: Open

Comments: HHS concurred with this recommendation. As of February 2020, HHS provided information describing actions it has taken to help increase the use of EHRs and electronic information exchange in post-acute care settings. These actions are important, but do not address the comprehensive planning that GAO recommended. To fully implement this recommendation, HHS should provide information to show comprehensive planning for how HHS's specific actions are expected to lead to achieving the goal of increasing the use of EHRs and electronic information exchange in post-acute settings.

Recommendation: To improve the collection of complete and consistent personal care services data and better ensure CMS can effectively monitor the states' provision of and spending on Medicaid personal care services, CMS should better ensure that personal care services data collected from states through T-MSIS and MBES comply with CMS reporting requirements.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: The Centers for Medicare & Medicaid Services (CMS) concurs with GAO's recommendation. In December 2017, CMS cited ongoing efforts related to claims data submitted by states through T-MSIS, CMS's new claims reporting system. Efforts included validation checks of personal care service claims to ensure that key data are not missing or incorrect. In addition, CMS stated it was working with the states to address concerns that are identified with the quality of claims data submitted. However, as of March 2020, CMS had not reported that it had addressed inaccurate state reporting of expenditures through CMS's expenditure reporting system, Medicaid Budget and Expenditure System (MBES). Complete implementation of the recommended action will better ensure state reporting of claims and expenditures is accurate and will allow CMS to effectively perform key management functions.

Recommendation: To improve the collection of complete and consistent personal care services data and better ensure CMS can effectively monitor the states' provision of and spending on Medicaid personal care services, CMS should develop plans for analyzing and using personal care services data for program management and oversight.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: The Centers for Medicare & Medicaid Services (CMS) concurred with this recommendation. However, as of March 2020, CMS had not developed a plan for analyzing and using personal care services data as GAO recommended in January 2017. Developing a plan for analyzing and using personal care services data for program management and oversight is an important step CMS needs to take to improve the oversight and management of personal care services.

Recommendation: To help ensure that HHS agencies and offices fully understand the requirements and processes for the temporary reassignment authority, their responsibilities under the authority, and that ASPR is adequately and comprehensively assessing the effect of the authority on public health emergency response and medical surge, the Secretary of HHS should direct ASPR to conduct outreach to HHS agencies and offices that administer programs eligible for the reassignment authority to inform them of their responsibilities and ASPR's expected time frames for reviewing and approving states' and tribes' requests for personnel reassignments, and inform them of their responsibilities and ASPR's expectations for reviewing states' and tribes' after-action reports.

Agency: Department of Health and Human Services
Status: Open

Comments: HHS provided us with information on its efforts to share information about the temporary reassignment authority throughout the department. However, it is not clear that HHS has routed the temporary reassignment standard operation procedures, which provides instructions on how to request use of the authority and documentation and reporting requirements, with the HHS agencies that are likely to be primarily affected.

Recommendation: To improve oversight of states' payment structures for MLTSS, the Administrator of CMS should require all states to collect and report on progress toward achieving MLTSS program goals, such as whether the program enhances the provision of community-based care.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: As of June 2020, CMS has not informed us of any additional actions taken to implement this recommendation. CMS previously reported that it is working to develop guidance on how states report on progress towards achieving MLTSS program goals, such as the extent to which the program enhances the provision of community-based care. CMS has contracted with a vendor to produce recommendations for what would be included in the state reporting. We will update the status of this recommendation when we receive additional information.

Recommendation: To improve oversight of states' payment structures for MLTSS, the Administrator of CMS should establish criteria for what situations would warrant exceptions to the federal standards that the data used to set rates be no older than the three most recent and complete years.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: As of June 2020, CMS has not informed us of any additional actions taken to implement this recommendation. CMS previously reported that it has monitored rate certifications and the data used for rating periods starting on or after July 1, 2017. CMS said that it has not had any states set rates that do not meet the federal standards for the data being no older than the three most recent and complete years and, therefore, does not believe that it should publish guidance on what situations would warrant exceptions. In order to better determine whether there is a need for such guidance, we believe that CMS should continue to monitor rate certifications and assess the data being used, particularly as additional states are developing or considering implementation of MLTSS programs. We will update the status of this recommendation as CMS conducts reviews of other states' payment structures and data used to establish them.

Recommendation: To improve oversight of states' payment structures for MLTSS, the Administrator of CMS should provide states with guidance that includes minimum standards for encounter data validation procedures.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: As of June 2020, CMS has not informed us of any additional actions taken to implement this recommendation. CMS previously reported to GAO that it has convened a workgroup to develop an Encounter Data Toolkit, which will provide best practices for encounter data submissions and validation procedures. The workgroup is also discussing minimum standards for states to determine if the encounter data are complete and accurate for purposes of rate setting. The workgroup met in June and July 2018, and two additional workgroup meeting are planned prior to the drafting of the toolkit. We will update the status of this recommendation when we receive additional information.

Recommendation: To accelerate efforts to develop a modern, credible, and effective performance management system the Assistant Secretary for HR&A should, with input from VHA stakeholders, ensure that meaningful distinctions are being made in employee performance ratings by (1) developing and implementing a standardized, comprehensive performance management training program for supervisors of Title 5, Title 38, and Title 38-Hybrid employees based on leading practices and ensuring procedures are in place to support effective performance conversations between supervisors and employees; (2) reviewing and revising Title 5 and Title 38 performance management policies consistent with leading practices (e.g., require definition of all performance levels); and (3) developing and implementing a process to standardize performance plan elements, standards, and metrics for common positions across VHA that are covered under VA's Title 5 performance management system.

Agency: Department of Veterans Affairs: Assistant Secretary for Human Resources and Administration
Status: Open
Priority recommendation

Comments: VA partially agreed with GAO's December 2016 recommendation. As of January 2020, VA has made progress toward addressing this recommendation. VA officials described a new pilot performance management system that is being used to develop an enterprise-wide performance management solution. VA officials also stated that they were developing policy revisions for performance management that are scheduled to be completed later this year. These actions, when fully implemented, should help VA make meaningful distinctions in performance and hold employees accountable.

Recommendation: To accelerate efforts to develop a modern, credible, and effective performance management system, the Assistant Secretary for HR&A should, with input from VHA stakeholders, develop a plan for how and when it intends to implement a modern information technology (IT) system to support employee performance management processes.

Agency: Department of Veterans Affairs: Assistant Secretary for Human Resources and Administration
Status: Open
Priority recommendation

Comments: The Department of Veterans Affairs (VA) partially agreed with GAO's December 2016 recommendation and as of January 2020 has made progress toward implementing the recommendation. For example, VA officials told GAO that they implemented a pilot project to develop a standard IT performance management system that started with about 12,000 employees and has expanded to about 67,00 employees. They told GAO that they are currently in the process of developing an enterprise-wide performance management IT solution. Activities such as finalizing a business case and analyzing alternatives are still in progress. GAO will continue to monitor VA's progress on this effort. Successful planning and implementation of a modern IT system should help VA capture reliable, timely, department-wide employee performance information and may also help VA realize cost savings by eliminating inefficient paper-based procedures.

Recommendation: To help ensure that FDA's foreign offices are able to fully meet their mission of helping to ensure the safety of imported products, as the agency continues to test performance measures and evaluate its Office of International Programs (OIP) strategic workforce plan, the Commissioner of FDA should assess the effectiveness of the foreign offices' contributions by systematically tracking information to measure whether the offices' activities specifically contribute to drug safety-related outcomes, such as inspections, import alerts, and warning letters.

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open
Priority recommendation

Comments: In June and July 2018 FDA reported on its recent efforts to assess the effectiveness of the foreign offices' contributions to drug-safety related outcomes. These efforts include the development of new performance measures for these offices along with a monitoring and evaluation plan; strengthened communications and collaboration between the foreign offices and FDA program centers and its Office of Regulatory Affairs; and an assessment of the foreign offices to help set their objectives and ensure the right balance of personnel, skillsets, and resources. However, FDA still had to develop intermediate outcomes to link with final outcomes. In an August 2020 written response, the agency reported that because of a reorganization and strategic planning effort for its Office of Global Policy and Strategy, it was still revising and updating its measures and its approach to evaluating impact in 2020 to align with a five-year strategic plan completed in March 2020. The agency indicated that the recommendation should remain open, and GAO will continue to monitor the implementation of this recommendation.

Recommendation: To improve care for women veterans, the Secretary of Veterans Affairs should direct the Under Secretary for Health to strengthen the environment of care inspections process and VHA's oversight of this process by expanding the list of requirements that facility staff inspect for compliance to align with VHA's women's health handbook, ensuring that all patient care areas of the medical facility are inspected as required, clarifying the roles and responsibilities of VA medical facility staff responsible for identifying and addressing compliance, and establishing a process to verify that noncompliance information reported by facilities to VHA Central Office is accurate and complete.

Agency: Department of Veterans Affairs
Status: Open

Comments: As of October 2018, VA has taken some actions to address this recommendation, but additional actions are needed to fully implement it. We will update the status of this recommendation when we receive additional information from VA.

Recommendation: To improve care for women veterans, the Secretary of Veterans Affairs should direct the Under Secretary for Health to monitor women veterans' access to key sex-specific care services--mammography, maternity care, and gynecology--under current and future community care contracts. For those key services, monitoring should include an examination of appointment scheduling and completion times, driving times to appointments, and reasons appointments could not be scheduled with community providers.

Agency: Department of Veterans Affairs
Status: Open
Priority recommendation

Comments: As of June 2017, VHA still lacks data and performance measures for the availability under Choice of sex-specific care, such as mammograms, maternity care, or gynecology. In contrast, for another VA care in the community program, PC3 (a program that the Choice third party administrators also administer) VHA collects data and has performance measures to evaluate women veterans' access to mammography and maternity care. To fully implement this recommendation, VHA needs to extend the collection of data to include care delivered through the Choice Program and other community care programs and establish related performance measures. VA is in the process of letting contracts for its new community care program and is expected to have contracts in place for all regions of the country in fiscal year 2019

Recommendation: To achieve a better understanding of the effect of certain Personal care services (PCS) services on beneficiaries and a more consistent administration of policies and procedures across PCS programs, the Acting Administrator of CMS should collect and analyze states' required information on the impact of the Participant-Directed Option and Community First Choice programs on the health and welfare of beneficiaries as well as the state quality measures for the Participant-Directed Option and Community First Choice programs.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: The Centers for Medicare & Medicaid Services (CMS) concurred with GAO's recommendation. On December 30, 2016, the agency issued guidance on the Community First Choice program to assist states in submitting information to CMS on the health and welfare of beneficiaries. In March 2019, CMS officials stated that the agency is currently developing the process for states to report this information to CMS. Agency officials also stated they are exploring the value of collecting this information for the Participant-Directed Option program given the limited number of states currently operating under this authority. In February 2020, CMS officials stated that the agency continues to develop policy related to this recommendation.

Recommendation: To help improve the Five-Star System's ability to enable consumers to understand nursing home quality and make distinctions between high- and low- performing homes, the Administrator of CMS should add information to the Five-Star System that allows consumers to compare nursing homes nationally.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS did not concur with this recommendation. CMS officials told us in July 2019 that they do not plan to implement this recommendation. We maintain that adding national comparison information is important.

Recommendation: To make it more likely that HHS will achieve its goals to reduce quality measure misalignment and associated provider burden, the Secretary of HHS should direct CMS and the Office of the National Coordinator for Health Information Technology to prioritize their development of electronic quality measures and associated standardized data elements on the specific quality measures needed for the core measure sets that CMS and private payers have agreed to use.

Agency: Department of Health and Human Services
Status: Open

Comments: In January 2019, HHS told us that CMS completed an analysis to determine which measures-from the core measure sets that CMS and private payers have agreed to use-are feasible to develop as electronic clinical quality measures. Further, in April 2019, CMS officials told us they will consider developing new electronic clinical quality measures where appropriate and feasible to fill future measure needs or gaps identified by the Core Quality Measures Collaborative (CQMC). However, we determined that the actions did not fully address the recommendation because they do not include efforts to work with ONC to prioritize their development of electronic clinical quality measures for the CQMC core measure sets. We will update the status of this recommendation when we receive additional information.

Recommendation: To make it more likely that HHS will achieve its goals to reduce quality measure misalignment and associated provider burden, the Secretary of HHS should direct CMS to comprehensively plan, including setting timelines, for how to target its development of new, more meaningful quality measures on those that will promote greater alignment, especially measures to strengthen the core measure sets that CMS and private payers have agreed to use.

Agency: Department of Health and Human Services
Status: Open

Comments: In April 2019, HHS told us that CMS had conducted an assessment of the impact of selected measures used in its quality programs and has linked key component of that assessment to some meaningful measure areas that CMS has identified as priorities. However, this document did not include elements of a comprehensive plan--such as setting timelines-for how to target its development of new, more meaningful quality measures that will promote greater alignment. We will update the status of this recommendation when we receive additional information.

Recommendation: To fully assess the size and composition of the medical force, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to conduct a new analysis of the required number of active-duty and civilian medical personnel that mitigates known limitations.

Agency: Department of Defense
Status: Open

Comments: DOD concurred with this recommendation. As of August 2020, DOD has not addressed this recommendation. In response to a provision in Senate Report 115-125, we assessed DOD's interim and final draft responses to a requirement in the National Defense Authorization Act (NDAA) for Fiscal Year 2017 to assess the required number of wartime medical and dental personnel. In our ensuing February 2019 report, we found that DOD had not determined the required size and composition of its operational medical and dental personnel who support the wartime mission or submitted a complete report to Congress. Specifically, leaders from the Office of the Secretary of Defense (OSD) disagreed with the military departments' initial estimates of required personnel that were developed to report to Congress. OSD officials cited concerns that the departments had not applied assumptions for operating jointly in a deployed environment and for leveraging efficiencies among personnel and units. We found that the military departments applied different planning assumptions in estimating required personnel, such as the definition of "operational" requirements. Further, although not required by the NDAA for Fiscal Year 2017, DOD's assessment did not include civilian medical personnel. Until DOD completes such an analysis, it cannot be assured that its medical force is appropriately sized.

Recommendation: To strengthen ongoing efforts to analyze the costs of medical force readiness and establish clinical currency standards, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to take steps to identify and mitigate limitations regarding the standard for maintaining providers' clinical skills, including improving the accuracy of information concerning providers' workload and conducting an analytically rigorous calculation of active-duty providers' time devoted to military-specific responsibilities.

Agency: Department of Defense
Status: Open

Comments: DOD concurred with this recommendation. As of August 2020, DOD has taken steps to address this recommendation, but has not completed all necessary actions. In February 2019, we reported that DOD had begun work on a metric to assess the clinical readiness of providers, but noted that the department's methodology was limited. In particular, the methodology did not provide complete, accurate, and consistent data or fully demonstrate results. Further, although DOD provided documentation in February 2020 outlining the medical specialties to which its clinical readiness metric would apply, it has not fully budgeted for the cost of implementing the metric. DOD's July 2018 report in response to Section 703 of the National Defense Authorization Act for Fiscal Year 2017 notes steps taken to assess the accuracy of information concerning providers' workload, but does not address the time active-duty providers devote to military-specific responsibilities. Until DOD addresses these issues, its efforts to analyze the costs of medical force readiness and establish clinical currency standards will remain limited.

Recommendation: To help achieve DOD's goals for transferring health care into its own facilities and increasing the productivity of active-duty medical providers, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to develop a strategy for achieving these goals that reflects the leading practices of effective federal strategic planning.

Agency: Department of Defense
Status: Open

Comments: DOD concurred with this recommendation. As of September 2020, DOD has not yet addressed this recommendation.

Recommendation: To strengthen ongoing efforts within DOD to address the Study's recommendations to use the provider model outputs to inform execution of health care delivery and to refine the model for future use, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to modify DOD's model to reflect the military service of the physicians and military treatment facilities included in the model.

Agency: Department of Defense
Status: Open

Comments: DOD concurred with this recommendation. As of September 2020 DOD has not implemented this recommendation. In its July 2018 report in response to Section 703 of the National Defense Authorization Act for Fiscal Year 2017, DOD stated in response to this recommendation that facilities in several large Military Health System (MHS) markets are staffed in a multi-service manner. While this is an important point, it remains true that, as the report notes, DOD's model "assumed uniformed providers were interchangeable," and that such an approach does not reflect the single-service nature of most medical treatment facilities within the MHS. Until DOD's model reflects this, the results of its approach will continue to be limited.

Recommendation: To strengthen any future assessments of additional changes to DOD's network of military treatment facilities, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to describe steps taken to assess the reliability of data supporting the assessment, including, at a minimum, the sources of data, data limitations, and efforts to test data reliability.

Agency: Department of Defense
Status: Open

Comments: DOD concurred with this recommendation. As of September 2020, DOD has taken steps to address this recommendation, but has not completed all necessary actions. In its July 2018 report in response to Section 703 of the National Defense Authorization Act for Fiscal Year 2017, DOD included the sources of its data and some data limitations, but not efforts to test data reliability. Until DOD fully incorporates assessments of data reliability into its analysis of future changes to the Military Health System, such as its implementation plan Section 703, it will continue to lack assurance that its approach is fully supported by reliable information.

Recommendation: To strengthen any future assessments of additional changes to DOD's network of military treatment facilities, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to include in any accompanying cost estimates an appropriate level of detail, all significant costs, and an assessment of the reliability of the data supporting the cost estimate.

Agency: Department of Defense
Status: Open

Comments: DOD concurred with this recommendation. As of September 2020, DOD has not addressed this recommendation. As we reported in May 2020, DOD's plan to restructure MTFs in response to Section 703 of the National Defense Authorization Act for Fiscal Year 2017, DOD concluded that civilian health care was more cost-effective than care in its MTFs without considering other assumptions that could affect its conclusions. For example, DOD applied assumptions about the cost of military personnel salaries, MTF workloads, and reimbursement rates for TRICARE that likely underestimated the cost-effectiveness of MTFs. Until DOD's approach to assessing changes to its network of MTFs is accompanied by cost estimates with an appropriate level of detail, all significant costs, and an assessment of the reliability of the data supporting the cost estimate, its approach will remain limited.

Recommendation: To improve the accessibility and reliability of SNF expenditure data, the Acting Administrator of CMS should take steps to improve the accessibility of SNF expenditure data, making it easier for public stakeholders to locate and use the data.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: In September 2016, GAO recommended that CMS improve the accessibility and reliability of SNF expenditure data, thereby making it easier for public stakeholders to locate and use the data. The agency concurred with this recommendation in 2016 and stated that it would review the feasibility of increasing the accessibility of this data. However, in August 2017, HHS told GAO that it now believes that the cost of implementing this recommendation would outweigh its benefits. HHS confirmed in July 2019 that its position on this recommendation has not changed. GAO continues to hold that data on SNFs' relative expenditures should be readily accessible to the public to ensure transparency in SNF expenditures.

Recommendation: To improve the accessibility and reliability of SNF expenditure data, the Acting Administrator of CMS should take steps to ensure the accuracy and completeness of SNF expenditure data.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: In September 2016, GAO recommended that CMS take steps to ensure the accuracy and completeness of SNF expenditure data. However, the agency did not concur with this recommendation. HHS reported in 2016 that the amount of time and resources to verify the accuracy and completeness of SNF expenditure data could be substantial, without assurance of benefit to the agency and the public. However, during the course of our work, GAO found that CMS uses this expenditure data to update overall SNF payment rates, in addition to more general purposes. GAO continues to believe that CMS should take steps to ensure reliable expenditure data are accurate and complete. As of July 2019, the agency continues to non-concur with this recommendation.

Recommendation: As NIH-DFAS begins formalizing its internal guidance, the Director of NIH-DFAS should establish a mechanism for tracking key milestones in the indirect cost rate-setting process, such as when indirect cost rate proposals are due.

Agency: Department of Health and Human Services: Public Health Service: National Institutes of Health: Office of Management: Office of Acquisition and Logistics Management: Office of Acquisition Management and Policy: Division of Financial Advisory Services
Status: Open

Comments: HHS concurred with this recommendations. In response, HHS stated that National Institute of Health's Division of Financial Advisory Services (DFAS) will establish a mechanism for tracking key milestones in the indirect cost rate-setting process. NIH-DFAS has initiatives underway that include moving from paper to electronic submissions of indirect cost proposals and developing a replacement to its Commercial Rate Agreement Distribution Services website. DFAS is looking into the feasibility of incorporating key milestones into these two major initiatives. NIH-DFAS is currently working with a contractor to develop a web based system that will establish a tracking system to account for when indirect cost proposal are due from organizations. The original initiative to enable the electronic submission of indirect cost proposals was modified to incorporate this new requirement. NIH-DFAS anticipates the planned date for implementation of this system to be October 1, 2017. As of February 4, 2020, this recommendation is still open because DFAS does not have the "proposal due date" and "extension due date" data fields activated in eFLow. DFAS is looking into adding those enhancements and hope to have these updates implemented by June 30, 2020. On July 8th, 2020, NIH-DFAS notified us that they plan to update us with the status of this recommendation by October 2020. We will continue to monitor the status of this recommendation.

Recommendation: To understand the extent to which incomplete inactivation occurs and whether incidents are being properly identified, analyzed, and addressed, the Secretary of Health and Human Services should direct the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) to develop clear definitions of inactivation for use within their respective guidance documents that are consistent across the Select Agent Program, NIH's oversight of recombinant pathogens, and the Biosafety in Microbiological and Biomedical Laboratories manual.

Agency: Department of Health and Human Services
Status: Open

Comments: As of April 2020, the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) within the Department of Health and Human Service (HHS) are taking steps to address this recommendation. Specifically, in January and March 2017, HHS, in collaboration with the United States Department of Agriculture (USDA), issued updated select agent regulations and guidance that included clear definitions of inactivation and a validated inactivation procedure that are consistent across the Federal Select Agent Program. Additionally, HHS stated in December 2016 that NIH will consider providing clear and consistent definitions of inactivation in future guidance that is harmonized with the select agent regulations. Moreover, NIH and CDC told us they plan to include a new appendix in the revised Biosafety in Microbiological and Biomedical Laboratories manual that specifically addresses the development, validation, and implementation of inactivation protocols, which they anticipate releasing in June 2020, according to a CDC official.

Recommendation: To help ensure that inactivation protocols are scientifically sound and are effectively implemented, the Secretary of Health and Human Services should direct CDC and NIH to create comprehensive and consistent guidance for the development, validation, and implementation of inactivation protocols--to include the application of safeguards--across the Select Agent Program, NIH's oversight of recombinant pathogens, and the Biosafety in Microbiological and Biomedical Laboratories manual.

Agency: Department of Health and Human Services
Status: Open

Comments: In March 2017, the Department of Health and Human Services (HHS), in collaboration with the United States Department of Agriculture (USDA), issued Federal Select Agent Program guidance on the inactivation of select agents and toxins. According to HHS, this guidance is intended to provide additional information to regulated entities to assist them in meeting new requirements for rendering samples with select agents as non-viable. HHS also stated that the Federal Select Agent Program will continue to work with other federal agencies to ensure that the federal government is addressing inactivation in a consistent manner. In addition, according to HHS, the National Institutes of Health (NIH) will consider providing clear and consistent guidance related to inactivation that is harmonized with the Federal Select Agent Program as appropriate. As of April 2020, NIH and the Centers for Disease Control and Prevention (CDC) were in the process of revising the Biosafety in Microbiological and Biomedical Laboratories manual to include a new appendix that addresses the development, validation, and implementation of inactivation protocols. HHS plans to release the updated manual in June 2020, according to a CDC official.

Recommendation: To help ensure that dangerous pathogens can be located in the event there is an incident involving incomplete inactivation, the Secretary of Health and Human Services should direct the Directors of CDC and NIH, when updating the Biosafety in Microbiological and Biomedical Laboratories manual, to include guidance on documenting the shipment of inactivated material.

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services (HHS) stated in March 2017 that the National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC) are in the process of revising the Biosafety in Microbiological and Biomedical Laboratories manual to include a new appendix that addresses inactivation methods, including guidance on documenting the shipment of inactivated material. HHS plans to release the updated manual in June 2020, according to a CDC official.

Recommendation: To improve the effectiveness of HHS guidance and oversight of privacy and security for health information the Secretary of Health and Human Services should establish performance measures for the Office of Civil Rights (OCR) audit program.

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services (HHS) concurred with the recommendation but has not yet provided sufficient evidence that it had implemented the recommendation. In particular, as of August 2020, the HHS Office for Civil Rights (OCR) has not yet reviewed the feasibility of performance measures as part of its audit program, and plans to do so only after implementing a future redesign of its audit program. We will continue to monitor HHS actions in response to this recommendation.

Recommendation: To determine the suitability of Medicare's Part B drug payment rate methodology for drugs with coupon programs, Congress should consider (1) granting CMS the authority to collect data from drug manufacturers on coupon discounts for Part B drugs paid based on ASP, and (2) requiring the agency to periodically collect these data and report on the implications that coupon programs may have for this methodology.

Agency: Congress
Status: Open

Comments: As of August 2020, Congress had not passed legislation to address this Matter for Congressional Consideration. We will update the status of this Matter if such action occurs.

Recommendation: To increase oversight of the Army's Warrior Transition Unit program, the Secretary of the Army should direct the Army Surgeon General to assess the Triad of Care model's effectiveness in light of the changes in WTU diagnoses and take the appropriate action.

Agency: Department of Defense: Department of the Army
Status: Open

Comments: The Army concurred with this recommendation. As of August 2020, an Army Medical Command official stated that the Warrior Transition Unit manpower model is under review by the U.S. Army Manpower Analysis Agency and that the scheduled date for the release of the review is unknown.

Recommendation: To help the Department of Health and Human Services ensure accuracy in Part B drug payment rates, Congress should consider requiring all manufacturers of Part B drugs paid at ASP, not only those with Medicaid drug rebate agreements, to submit sales price data to CMS, and ensure that CMS has authority to request source documentation to periodically validate all such data.

Agency: Congress
Status: Open

Comments: As of June 2020, no action has been taken on this Matter for Congressional Consideration.

Recommendation: CMS should periodically verify the sales price data submitted by a sample of drug manufacturers by requesting source documentation from manufacturers to corroborate the reported data, either directly or by working with the HHS Office of Inspector General as necessary.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: In September 2018, HHS officials reiterated that they believe the agency has addressed our recommendation because CMS works with HHS's Office of Inspector General (OIG) as appropriate to collect source documentation from drug manufacturers and takes action as warranted. HHS stated that CMS has continued to provide information regarding problematic ASP submissions to OIG for evaluation of misreporting and continues to use AMP and other benchmarks as comparisons for pricing determinations. They further stated that they do not believe that additional collection of detailed sales information about ASP, such as invoices, is authorized under Part B drug payment provisions in section 1847A or under section 1927(b). As of June 2020, CMS did not provide any additional updates. While we recognize that CMS conducts routine checks to assess the completeness of ASP data submitted by drug manufacturers, we do not believe these activities are enough to close the recommendation. Specifically, CMS only collects source documentation from manufacturers under very limited circumstances (e.g., when there are obvious inconsistencies in the data submitted by manufacturers). CMS does not periodically verify the accuracy of ASP data for a sample of manufacturers by tracing the data to and from drug manufacturers' source documents, such as sales invoices. Because CMS does not routinely verify the accuracy of the underlying data used to determine Medicare payment rates, the resulting payment rates may be inaccurate if drug manufacturers do not report accurate data. With regards to CMS's authority to collect additional information, such as invoices, we believe the agency could work through OIG to collect such information.

Recommendation: To ensure efficient use of federal resources, the Administrator of CMS should account for Medicaid payments a hospital has received that offset uncompensated care costs when determining hospital uncompensated care costs for the purposes of making Medicare UC payments to individual hospitals.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open
Priority recommendation

Comments: No executive action taken as of March 2020. CMS initially agreed with GAO's June 2016 recommendation. However, in October 2018, and again in December 2019 , CMS indicated that it was reconsidering whether to offset Medicare Uncompensated Care (UC) payments by Medicaid's uncompensated care payments. CMS stated that because Medicare UC payments are distributed based on hospitals' relative (not actual) uncompensated care costs, it would not be appropriate to account for Medicaid payments that reduce hospital uncompensated care. However, in some states Medicaid payments reduce or even eliminate hospital uncompensated care costs, which can result in an inequitable distribution of payments. Because the total amount of Medicare UC payments is capped, not accounting for Medicaid payments will result in hospitals that have little or no uncompensated care costs receiving a higher proportion of Medicare UC payments than warranted, resulting in in less funding for hospitals that actually have uncompensated care costs. Implementing GAO's recommendation would ensure that Medicare UC payments are based on accurate levels of uncompensated care costs and result in CMS better targeting billions of dollars in Medicare UC payments to hospitals that do have with the most uncompensated care costs, while avoiding making payments to hospitals with little or no uncompensated care costs.

Recommendation: To make the best use of federal resources directed toward combating FGM/C in the United States, the Attorney General and the Secretaries of Education, Health and Human Services, Homeland Security, and State should each develop a written plan that describes the agency's approach for conducting education and outreach to key stakeholders in the United States regarding FGM/C.

Agency: Department of Education
Status: Open

Comments: The Department of Education (Education) concurred with this recommendation. In February 2020, Education told us that it had awarded three grants that, while not focused on FGM/C, may be used for student safety and health at the U.S. state and local levels. After it evaluates grantees' need for information and resources related to FGM/C, Education will determine its next steps. In addition, Education reported that it continues to participate on the federal interagency workgroup devoted to FGM/C and has dedicated program staff to respond to issues related to FGM/C. Education expects to finalize its written plan by August 2020.

Recommendation: To make the best use of federal resources directed toward combating FGM/C in the United States, the Attorney General and the Secretaries of Education, Health and Human Services, Homeland Security, and State should each communicate the plan with other relevant federal agencies and stakeholder groups, as appropriate.

Agency: Department of Education
Status: Open

Comments: The Department of Education (Education) concurred with this recommendation, and noted in a February 2020 update that it is in the process of determining next steps for certain FGM/C awareness activities that may be included in the written plan it will develop. Education expects that it will finalize its written plan by August 2020, at which point it should also communicate that plan with other federal agencies and stakeholder groups to address our recommendation.

Recommendation: To help ensure that practitioners who may be ineligible do not possess a controlled substance registration and that practitioners who pose an increased risk of illicit diversion are identified, the Acting Administrator of DEA should take additional actions to strengthen verification controls. Specifically, the Acting Administrator of DEA should develop policies and procedures to validate SSNs and apply the policies and procedures to all new and existing SSNs in the CSA2; such an approach could involve collaborating with SSA to assess the feasibility of checking registrants' SSNs against the Enumeration Verification System.

Agency: Department of Justice: Drug Enforcement Administration
Status: Open

Comments: In April 2018, DEA told us that it assessed the feasibility of directly collaborating with SSA to check registrants' SSNs against any SSA systems, including the Enumeration Verification System (EVS), and is unable to implement a data verification process to validate SSNs against EVS without legislative authority. Specifically, DEA said that access to SSA's systems would require passage of new legislation to authorize DEA to fully participate in a data exchange agreement with SSA, which DEA said was also confirmed by Senate staff. In June 2020, DEA provided documentation of SSA's response to DEA's request to access EVS which stated that SSA was unable to enter into a data exchange under the conditions DEA initially proposed. However, it also stated that SSA would explore granting DEA access if DEA requested number-holder's consent. Therefore, we continue to believe there is a possible path forward in using SSA's service. Additionally, DEA told us that it would use information from the Federation of State Medical Boards (FSMB) to validate SSNs. However, as of August 2020, DEA has not provided any documentation to support how or if this has been implemented. Further, as noted in our report, FSMB is limited to information for medical doctors, osteopathic doctors and some physician assistants, which make up only a portion of DEA's registrants. As we noted in our report, validating SSNs will help establish registrants' identities which will better ensure DEA has the information necessary to implement its existing controls and to identify other registrations held by each individual, including past adverse actions taken against previous registrations. As such, we continue to believe that DEA should take steps to validate the information it receives. We will continue to monitor the agency's progress in this area.

Recommendation: To help ensure that practitioners who may be ineligible do not possess a controlled substance registration and that practitioners who pose an increased risk of illicit diversion are identified, the Acting Administrator of DEA should take additional actions to strengthen verification controls. Specifically, the Acting Administrator of DEA should identify and implement a cost-effective approach to monitor state licensure and disciplinary actions taken against its registrants; such an approach could include using data sources that contain this information, such as the National Practitioner Data Bank or the Federation of State Medical Boards.

Agency: Department of Justice: Drug Enforcement Administration
Status: Open

Comments: In July 2018, DEA provided a copy of its purchase order award to the Federation of State Medical Boards (FSMB); however, as of August 2020, DEA has not provided documentation to demonstrate how use of FSMB will be implemented. Also, in April 2018, DEA said it was exploring how to establish a cost-effective system to obtain National Practitioner Data Bank (NPDB) information and will reevaluate the need to obtain NPDB information after DEA has had the opportunity to process the FSMB information. In June 2020, DEA stated it will not be taking additional action on obtaining NPDB. We will continue to monitor DEA's progress in implementing this recommendation.

Recommendation: To ensure that FDA can effectively coordinate and integrate its medical product centers' programs and emerging issues, the Secretary of Health and Human Services should direct the Commissioner of FDA to engage in a strategic planning process to identify challenges that cut across the medical product centers and document how it will achieve measurable goals and objectives in these areas.

Agency: Department of Health and Human Services
Status: Open

Comments: FDA concurred with the recommendation and in September 2016 and January 2018 described steps it had taken toward strategic planning for its medical product centers. However, in June 2020, FDA informed GAO that there had been several senior leadership changes and its agency-wide strategic planning process was paused to focus on the covid-19 pandemic response. Officials also noted that FDA continues to address existing strategic priorities. We will update the status of this recommendation when we receive additional information.

Recommendation: In order to improve FDA's strategic planning for regulatory science efforts, the Secretary of Health and Human Services should direct the Commissioner of FDA to develop and document measurable goals, such as targets and time frames, for its regulatory science efforts so it can consistently assess and report on the agency's progress in regulatory science efforts.

Agency: Department of Health and Human Services
Status: Open

Comments: In September 2018, the agency described the actions of committees developed by each of the centers to oversee their regulatory science activities. In July 2019, the agency indicated that it was revisiting its strategic regulatory science priorities as part of its cyclical strategic planning process, and the centers and various offices have taken steps to address the recommendation. In an August 2020 written response, the agency reported that a committee had undertaken a review its 2011 regulatory science strategic plan that will result in the issuance of an accountability framework--an internal document outlining the type of information that FDA centers and offices will provide to the agency's Chief Scientist to demonstrate progress made in addressing relevant focus areas of regulatory science. FDA reported that its goal was to complete this work by the end of December 2020. However, FDA still needs to document steps taken by these centers to develop measurable goals, and the agency indicated that the recommendation should remain open. GAO will continue to monitor the implementation of this recommendation.

Recommendation: In order to improve FDA's strategic planning for regulatory science efforts, the Secretary of Health and Human Services should direct the Commissioner of FDA to systematically track funding of regulatory science projects across each of its priority areas.

Agency: Department of Health and Human Services
Status: Open

Comments: In September 2018 and July 2019, the agency described actions taken by each center to better track its regulatory science funding. However, FDA still needed to complete these activities and document that funds are systematically tracked across each of the priority areas. In an August 2020 written response, the agency reported that there continue to be efforts to improve tracking of funds for regulatory science projects in priority areas. Specifically, it described the development of an accountability framework-an internal document outlining the type of information that FDA centers and offices will provide to the agency's Chief Scientist to demonstrate progress made in addressing relevant focus areas of regulatory science. According to FDA, as part of the internal accountability framework, it will track regulatory science projects. FDA reported that its goal was to complete this work by the end of December 2020. The agency indicated that the recommendation should remain open, and GAO will continue to monitor the implementation of this recommendation.

Recommendation: To reduce the number of Medicare appeals and to strengthen oversight of the Medicare FFS appeals process, the Secretary of Health and Human Services should direct CMS, Office of Medicare Hearings and Appeals (OMHA), or Departmental Appeals Board (DAB) to modify the various Medicare appeals data systems to collect information on the reasons for appeal decisions at Level 3.

Agency: Department of Health and Human Services
Status: Open

Comments: According to HHS as of August 2016, OMHA and DAB were considering the cost and technical feasibility of collecting this information within their appeals data systems. As of August 2018, OMHA has begun to take action on this recommendation. Specifically, in the July 2017 interim release of the Electronic Case Adjudication and Processing Environment (ECAPE) system, OMHA added a "Reason for Disposition" data field. However, the "Reason for Disposition" data field is currently limited in the number of reasons that can be selected, and ECAPE has not yet been rolled out to all OMHA offices. In May 2019, HHS reported that OMHA had modified the "Reason for Disposition" data field to capture more categories, and that DAB had modified its case management system to capture the reasons for appeal decisions at Level 3 and was working to develop system interoperability with ECAPE. In August 2019, OMHA officials noted that ECAPE had been implemented in 6 of OMHA's 10 field offices and was on track to implement ECAPE in all 10 field offices and its satellite office by the end of 2019. We will update the status of this recommendation when we receive additional information regarding DAB's efforts to implement this recommendation.

Recommendation: To reduce the number of Medicare appeals and to strengthen oversight of the Medicare FFS appeals process, the Secretary of Health and Human Services should direct CMS, OMHA, or DAB to modify the various Medicare appeals data systems to capture the amount, or an estimate, of Medicare allowed charges at stake in appeals in Medicare Appeals System (MAS) and Medicare Operations Division Automated Case Tracking System (MODACTS).

Agency: Department of Health and Human Services
Status: Open

Comments: According to HHS as of August 2016, this information was not captured in any CMS system, including MAS. HHS reported that if MAS is modified to capture the amount of Medicare allowed charges at stake, OMHA will consider modifying its Electronic Case Adjudication and Processing Environment (ECAPE) to include this information as well, and DAB can capture it in a new case management system currently being developed by the agency. As of August 2019, HHS officials stated that developing a methodology to estimate the amount that CMS would have paid providers is complex and would not be appropriate for use in determining whether the appeal meets the amount in controversy requirements for a Level 3 appeal. The basis for our recommendation was also so that HHS could better monitor important appeal trends. Additionally, without this information, HHS does not know the actual amount of Medicare reimbursement at issue in the appeals process. We will update the status of this recommendation when we receive additional information regarding HHS's efforts to implement it.

Recommendation: To reduce the number of Medicare appeals and to strengthen oversight of the Medicare FFS appeals process, the Secretary of Health and Human Services should direct CMS, OMHA, or DAB to modify the various Medicare appeals data systems to collect consistent data across systems, including appeal categories and appeal decisions across MAS and MODACTS.

Agency: Department of Health and Human Services
Status: Open

Comments: According to HHS as of August 2016, HHS reported taking several initial steps to standardize data across Medicare appeals systems. As of August 2018, HHS was continuing to take steps to implement GAO's recommendation to standardize data collection on appeals across its multiple data systems. Specifically, HHS stated that, in November 2016, CMS and OMHA modified the MAS system to standardize appeal categories between Levels 1 through 3, which will help to facilitate more accurate trending analyses across appeal levels. Further, as of April 2017, all Part A Medicare Administrative Contractors (MAC), who are responsible for Part A Level 1 appeals, were successfully processing appeals in MAS, according to HHS. In August 2019, OMHA officials noted that the ECAPE system, which will interact with MAS for reporting purposes, had been implemented in 6 of OMHA's 10 field offices and would be implemented in all 10 field offices and its satellite office by the end of 2019. However, Part B and DME MACs, which are responsible for Part B and DME Level 1 appeals, have not been fully transitioned to MAS. Therefore, appeals categories are still inconsistent for these claims. According to HHS, CMS has not received funding to transition the remaining Level 1 appeals contractors to MAS. Additionally, HHS reported that DAB continues to explore ways to develop interoperability between MODACTS and OMHA's ECAPE system. Therefore, we will continue to monitor progress on the implementation of this recommendation.

Recommendation: In order to better ensure proper Medicare payments and protect Medicare funds, CMS should seek legislative authority to allow the RAs to conduct prepayment claim reviews.

Agency: Department of Health and Human Services
Status: Open
Priority recommendation

Comments: In April 2016, we recommended that the Centers for Medicare and Medicaid Services (CMS) should seek legislative authority to allow the Recovery Auditors (RAs) to conduct prepayment claim reviews. The Department of Health and Human Services did not concur with this recommendation, and the President's fiscal year 2021 budget did not include a proposal for such authority. We continue to believe CMS should seek legislative authority to allow RAs to conduct these reviews. Until CMS seeks and implements this authority, it will be missing an opportunity to help identify improper payments before they are made.

Recommendation: The Secretary of Health and Human Services should direct the Administrator of CMS to assess the feasibility of updating the agency's study on the effect of VA-provided Medicare-covered services on per capita county Medicare FFS spending rates by obtaining VA utilization and diagnosis data for veterans enrolled in Medicare FFS under its existing data use agreement or by other means as necessary.

Agency: Department of Health and Human Services
Status: Open

Comments: In December 2017, the U.S. Department of Health and Human Services (HHS) indicated that it had further reviewed our recommendation and determined that updating the agency's study on the effect of VA-provided Medicare-covered services on per capita county Medicare fee-for-service (FFS) spending rates using the Department of Veterans Affairs' (VA) utilization and diagnosis data was not feasible. Challenges cited by HHS included (1) pricing each VA encounter using Medicare payment rules; (2) determining which Medicare provider would have treated each beneficiary; and (3) the resources required to have an ongoing data feed with VA and to protect VA utilization and diagnosis data. While we acknowledge that there may be challenges associated with incorporating VA utilization and diagnosis data into HHS's analysis, we believe that HHS needs to do additional work before it can determine whether such an approach is feasible. For example, while HHS noted resource concerns related to sharing and storing sensitive VA data, the agency already receives and stores some VA data. It remains unclear whether HHS has assessed what additional resources would be needed to store VA utilization and diagnosis data and whether such data would need to be shared via an ongoing data feed-another challenge mentioned by HHS. As of June 2020, HHS has not provided us with any additional information about actions it has taken to address this recommendation. We continue to believe that HHS should assess the feasibility of implementing a methodology for estimating the effect of VA-provided Medicare-covered services on per capita county Medicare FFS spending rates that incorporates VA data.

Recommendation: If CMS makes an adjustment to the benchmark to account for VA spending on Medicare-covered services, the Secretary of Health and Human Services should direct the Administrator of CMS to assess whether an additional adjustment to MA payments is needed to ensure that payments to MA plans are equitable for veterans and nonveterans.

Agency: Department of Health and Human Services
Status: Open

Comments: In December 2017, the U.S. Department of Health and Human Services (HHS) indicated that there are a number of limitations that would impede the Centers for Medicare & Medicaid Services' (CMS) ability to conduct an analysis of veteran versus nonveteran payments to MA plans. HHS indicated that in order to conduct a thorough assessment, CMS would need utilization and diagnosis data from the Department of Veterans Affairs (VA), which would take several years to collect and analyze. In addition, HHS indicated that if CMS determined an adjustment was needed, the agency would have to overcome other data, operational, and financial challenges related to making the adjustment. As a result, HHS indicated that implementing such an adjustment would be infeasible. However, CMS currently adjusts the benchmark to account for VA spending on Medicare-covered services without VA utilization and diagnosis data. While we agree that VA utilization and diagnosis data may improve the accuracy of an adjustment to MA payments to ensure that payments to MA plans are equitable for veterans and nonveterans, it is unclear why CMS could not make an adjustment without VA utilization and diagnosis data. As of June 2020, HHS has not provided us with any additional information about actions it has taken to address this recommendation. In order for us to close this recommendation, CMS would need to assess whether an additional adjustment to MA payments is needed.

Recommendation: As CMS continues to implement and refine the contract-level RADV audit process to improve the efficiency and effectiveness of reducing and recovering improper payments and to improve the accuracy of CMS's calculation of coding intensity, the Administrator should modify that calculation by taking actions such as the following: (1) including only the three most recent pair-years of risk score data for all contracts; (2) standardizing the changes in disease risk scores to account for the expected increase in risk scores for all MA contracts; (3) developing a method of accounting for diagnostic errors not coded by providers, such as requiring that diagnoses added by MA organizations be flagged as supplemental diagnoses in the agency's Encounter Data System to separately calculate coding intensity scores related only to diagnoses that were added through MA organizations' supplemental record review (that is, were not coded by providers); and (4) including MA beneficiaries enrolled in contracts that were renewed from a different contract under the same MA organization during the pair-year period.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: CMS is working to improve the accuracy of its calculation of coding intensity, as GAO recommended in April 2016. In October 2017, CMS officials told GAO that the agency is reevaluating the design of the risk adjustment data validation audits to ensure their rigor in the context of all the payment error data acquired since the original design of the audits. As part of this work, CMS officials told GAO that the agency will examine whether coding intensity is the best criterion to use to select contracts for audit. As a result, in October 2018, CMS told GAO that rather than coding intensity, it plans to implement a new methodology using payment error as the key sampling driver beginning with audits for payment year 2014. Additionally, CMS was taking steps to modernize its audit system to improve reliability. For example, it initiated a project to explore how to directly receive electronic medical record documentation. As of January 2020, the agency is continuing to reevaluate the design of these audits. Unless CMS takes this and other actions to improve the risk adjustment data validation contract-level audit process, it will fail to recover improper payments of hundreds of millions of dollars annually.

Recommendation: As CMS continues to implement and refine the contract-level RADV audit process to improve the efficiency and effectiveness of reducing and recovering improper payments. The Administrator should modify CMS's selection of contracts for contract-level RADV audits to focus on those contracts most likely to have high rates of improper payments by taking actions such as the following: (1) selecting more contracts with the highest coding intensity scores; (2) excluding contracts with low coding intensity scores; (3) selecting contracts with high rates of unsupported diagnoses in prior contract-level RADV audits; (4) if a contract with a high rate of unsupported diagnoses is no longer in operation, selecting a contract under the same MA organization that includes the service area of the prior contract; and (5) selecting some contracts with high enrollment that also have either high rates of unsupported diagnoses in prior contract-level RADV audits or high coding intensity scores.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: CMS is working to modify the selection of MA contracts for audit, as GAO recommended in April 2016. In October 2017, CMS officials told GAO that the initial RADV audit design was based on a limited set of payment error data available at the time. As part of efforts to improve the audits, CMS officials told GAO that the agency will examine whether coding intensity is the best criterion to select contracts for audit. In October 2018, CMS told GAO that it plans to implement a new methodology using payment error as the key sampling driver-rather than coding intensity-beginning with audits for payment year 2014. As of January 2020, the agency is using the revised methodology on the 2014 and 2015 payment year audits. They expect to conclude this process in late fiscal year 2020 and 2021, respectively. Unless CMS completes actions to improve the RADV contract-level audit process, it will fail to recover improper payments of hundreds of millions of dollars annually.

Recommendation: As CMS continues to implement and refine the contract-level RADV audit process to improve the efficiency and effectiveness of reducing and recovering improper payments. The Administrator should enhance the timeliness of CMS's contract-level RADV process by taking actions such as the following: (1) closely aligning the time frames in CMS's contract-level RADV audits with those of the national RADV audits the agency uses to estimate the MA improper payment rate; (2) reducing the time between notifying MA organizations of contract audit selection and notifying them about the beneficiaries and diagnoses that will be audited; (3) improving the reliability and performance of the agency's process for transferring medical records from MA organizations, including assessing the feasibility of updating Electronic Submission of Medical Documentation for use in transferring medical records in contract-level RADV audits; and (4) requiring that CMS contract-level RADV auditors complete their medical record reviews within a specific number of days comparable to other medical record review time frames in the Medicare program.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open
Priority recommendation

Comments: HHS concurred with this recommendation in its fiscal year 2021 budget justification. HHS reaffirmed its commitment to identifying and correcting improper payments in the MA program. It has begun taking steps to improve the timeliness of the contract-level RADV audit process, such as aligning the time frames in CMS's contract-level RADV audits with those of the national RADV audits. Once completed, CMS needs to provide evidence that the actions taken by the agency have enhanced the timeliness of CMS's contract-level RADV process.

Recommendation: As CMS continues to implement and refine the contract-level RADV audit process to improve the efficiency and effectiveness of reducing and recovering improper payments. The Administrator should improve the timeliness of CMS's contract-level RADV appeal process by requiring that reconsideration decisions be rendered within a specified number of days comparable to other medical record review and first-level appeal time frames in the Medicare program.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: CMS is working to improve the timeliness of the agency's contract-level risk adjustment data validation appeals process, as GAO recommended in April 2016. In October 2017, CMS officials told GAO that the agency is actively considering options for expediting the appeals process. For example, CMS is considering the appropriate number of days for rendering reconsideration decisions while allowing for a complete and thorough adjudication. In December 2019, CMS officials told GAO they expect to issue a final rule in January 2021 that will establish uniform timelines to expedite the appeals process. Specifically, they plan to require that a findings determination be made within 60-90 days of an arbiter's receipt of each party's arguments at each stage of an appeal. Unless CMS takes such actions to improve the risk adjustment data validation contract-level audit process, it will fail to recover improper payments of hundreds of millions of dollars annually.

Recommendation: As CMS continues to implement and refine the contract-level RADV audit process to improve the efficiency and effectiveness of reducing and recovering improper payments. The Administrator should ensure that CMS develops specific plans and a timetable for incorporating a RAC in the MA program as mandated by the Patient Protection and Affordable Care Act.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: CMS has attempted to incorporate a recovery audit contractor in the Medicare Advantage program, as GAO recommended in April 2016. After failing to receive any proposals when CMS first issued a request for proposals (RFP) in 2014, CMS issued a request for information to industry in December 2015, which included a draft Statement of Work to solicit feedback, gauge interest, and conduct market research regarding CMS entering into a contract with a recovery audit contractor to identify underpayments and overpayments associated with diagnosis data submitted to CMS by Medicare Advantage Organizations. CMS reported that it subsequently issued another RFP in 2016 and did not receive any proposals for a second time. In December 2019, CMS officials told GAO that the functions of the Part C recovery Audit programs are being performed through other program integrity mechanisms. CMS subsequently reported in its fiscal year 2021 budget justification that CMS believes the proposed scope of the Part C RAC has been subsumed by RADV and CMS will demonstrate that the RADV program satisfies this recommendation. Until CMS completes efforts to improve the risk adjustment data validation contract-level audit process and demonstrates that it has satisfied the requirement to incorporate a recovery audit contractor in the MA program, CMS will fail to recover improper payments of hundreds of millions of dollars annually.

Recommendation: To improve the oversight of privacy and security controls over the state-based marketplaces, the Secretary of Health and Human Services should direct the Administrator of the Centers for Medicare & Medicaid Services to define procedures for overseeing state-based marketplaces, to include day-to-day activities of the relevant offices and staff.

Agency: Department of Health and Human Services
Status: Open

Comments: The agency concurred with the recommendation and is actively working on addressing the recommendation. We will continue to work with the agency to verify whether implementation has occurred.

Recommendation: To improve the oversight of privacy and security controls over the state-based marketplaces, the Secretary of Health and Human Services should direct the Administrator of the Centers for Medicare & Medicaid Services to require continuous monitoring of the privacy and security controls over state-based marketplaces and the environments in which those systems operate to more quickly identify and remediate vulnerabilities.

Agency: Department of Health and Human Services
Status: Open

Comments: The agency concurred with the recommendation and is actively working on addressing the recommendation. We will continue to work with the agency to verify whether implementation has occurred.

Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Agriculture should revise existing department policies for managing hazardous biological agents in high-containment laboratories to contain specific requirements for reporting laboratory incidents to senior department officials, including the types of incidents that should be reported, to whom, and when, or direct the Administrator of the Food Safety and Inspection Service to develop agency policies that contain these requirements.

Agency: Department of Agriculture
Status: Open

Comments: In October 2016, the United States Department of Agriculture (USDA) stated that its Joint Committee on Biorisk Management Policy (JCBMP) would oversee the revisions of existing policies to include department-wide incident reporting requirements and time frames. As of July 2020, USDA estimated that these revisions should be completed by October 2020. Officials stated that updates to component agency policies would be completed shortly after issuance of the departmental policy. We will update the status of this recommendation when we receive additional information.

Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Agriculture should review and update outdated department policies for managing hazardous biological agents in high-containment laboratories and direct the Administrators of the Animal and Plant Health Inspection Service (APHIS) and Agricultural Research Service to update their policies and, in the case of APHIS, establish a regular review schedule.

Agency: Department of Agriculture
Status: Open

Comments: In October 2016, USDA stated that the JCBMP would oversee the revisions of existing outdated departmental policies. In addition, officials stated that APHIS reviews and updates agency policies every 3-5 years, and that this schedule will be reflected in the updated departmental policy. In October 2019, the Agricultural Research Service (ARS) updated its agency policy for its institutional biological safety committee, the entity responsible for ensuring biosafety in its laboratories. As of July 2020, USDA estimated that revisions to the departmental, APHIS, and Food Safety and Inspection Service (FSIS) policies should be completed by December 2020. We will update the status of this recommendation when we receive additional information.

Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Agriculture should routinely analyze results of the department's laboratory inspections and incident reports to identify potential trends that may highlight recurring laboratory safety or security issues and share lessons learned with laboratory personnel.

Agency: Department of Agriculture
Status: Open

Comments: In October 2016, USDA stated that the JCBMP would oversee efforts to collect and analyze laboratory inspection results and incident reports and share these reports and critical analyses with USDA senior leadership on an annual basis. As of July 2020, USDA estimated that revisions to its departmental policy-which would reflect the JCBMP's role in analyzing inspection results and incident reports, identifying potential trends, and sharing lessons learned-should be completed by October 2020. We will update the status of this recommendation when we receive additional information.

Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Agriculture should require routine reporting of the results of department, agency, and select agent laboratory inspections to senior department officials.

Agency: Department of Agriculture
Status: Open

Comments: In October 2016, USDA stated that the JCBMP would oversee the revisions of existing policies to include requirements for routine reporting of inspection results to senior USDA officials. In July 2020, USDA estimated that these revisions should be completed by October 2020. We will update the status of this recommendation when we receive additional information.

Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Agriculture should require routine reporting of incidents at agency laboratories to senior department officials.

Agency: Department of Agriculture
Status: Open

Comments: In October 2016, USDA stated that the JCBMP would oversee the revisions of existing policies to include requirements for routine reporting of laboratory incidents to senior USDA officials. In July 2020, USDA estimated that these revisions should be completed by October 2020. Officials stated that updates to component agency policies would be completed shortly after issuance of the departmental policy. We will update the status of this recommendation when we receive additional information.

Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Defense should revise existing department policies for managing hazardous biological agents in high-containment laboratories to contain specific requirements for inventory control for all of DOD's high-containment laboratories, not just for its select agent-registered laboratories, or direct the Secretaries of the Air Force, Army, and Navy to revise their existing, respective policies to contain these requirements.

Agency: Department of Defense
Status: Open

Comments: DOD concurred with our recommendation. In June 2018, DOD stated that it had completed evaluation of existing DOD and service level guidance related to inventory control. DOD also stated that it will continue to analyze the adequacy of existing policy and the need to expand that policy across the DOD Lab Enterprise as the draft Department of Defense Manual (DoDM) 6055.18 is finalized for publication. As of August 2019, DoD said the draft DoDM 6055.18 was still in review and the agency estimated it would complete work to respond to this recommendation in February 2020.

Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Defense should direct the Secretaries of the Air Force and Army to review and update their respective outdated policies for managing hazardous biological agents in high-containment laboratories.

Agency: Department of Defense
Status: Open

Comments: DOD concurred with our recommendation. DOD stated that it had updated the Air Force policy (AF Instruction 10-2611-0) as of January 19, 2017; this document updates the biological safety standards used in AF labs and implements the draft update to Department of Defense Manual 6055.18M: Safety Standards for Microbiological and Biomedical Laboratories. As of July 2019, DOD provided GAO with the updated Army policy AR 190-17; however DOD officials stated that as the draft Department of Defense Manual (DoDM) 6055.18 was still undergoing review, this recommendation should remain open. DOD estimated it would complete work to respond to this recommendation in February 2020.

Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Defense should require routine reporting of the results of Air Force, Army, and Navy inspections of non-select agent registered laboratories to senior department officials.

Agency: Department of Defense
Status: Open

Comments: DOD concurred with our recommendation. In August 2019, DOD reported that the Air Force is planning to close its BSAT program by the summer of 2019 and planning was underway to move the Air Force BSAT inventory to another DOD BSAT facility. Additionally, the Army was revising its AR 385-10, which contains biosafety criteria unique to the Army, and estimated the revision would be completed by December 2019. Finally, the draft Department of Defense Manual (DoDM) 6055.18 was still undergoing review, and DOD estimated it would complete work to respond to this recommendation in February 2020.

Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Defense should require routine reporting of laboratory incidents at Air Force, Army, and Navy non-select agent registered laboratories to senior department officials.

Agency: Department of Defense
Status: Open

Comments: DOD concurred with our recommendation. In August 2019, DOD reported that the Air Force is planning to close its BSAT program by the summer of 2019 and planning was underway to move the Air Force BSAT inventory to another DOD BSAT facility. Additionally, the Army was revising its AR 385-10, which contains biosafety criteria unique to the Army, to include a new mishap classification for biosafety mishaps to effect better reporting and analysis of these mishaps, and estimated the revision would be completed by December 2019. Finally, the draft Department of Defense Manual (DoDM) 6055.18 was still undergoing review, and DOD estimated it would complete work to respond to this recommendation in February 2020.

Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Defense should direct the Secretaries of the Army and Navy to require reporting of agency and select agent laboratory inspection results to senior agency officials.

Agency: Department of Defense
Status: Open

Comments: DOD concurred with our recommendation. As of June 2018, DOD stated that the draft directive DODD 5101.XXE, which is expected to be published in October 2018, formally designates the Executive Agent Responsible Official for Biosafety and Biosecurity and will establish roles and responsibilities including a role for reporting inspection results. Further, DOD stated that all inspection results of a joint inspection team are provided to the Executive Agent Responsible Official, and that the joint inspection team was established in September 2016. As of September 2019, DOD officials had provided updated documentation regarding this recommendation, and GAO was reviewing these updates.

Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Health and Human Services should develop department policies for managing hazardous biological agents in high-containment laboratories that contain specific requirements for reporting laboratory incidents to senior department officials, including the types of incidents that should be reported, to whom, and when, or direct the Director of CDC and the Commissioner of FDA to incorporate these requirements into their respective policies.

Agency: Department of Health and Human Services
Status: Open

Comments: In August 2016, HHS reported that both CDC and FDA were working to incorporate incident reporting requirements and time frames into formal agency policies and practices but did not provide an anticipated completion date. In summer 2017, CDC and FDA reported that they were continuing to incorporate incident reporting, which includes all laboratory incidents, accidents, injuries, infections, and near-misses, into formal agency policies. In August 2019, FDA reported that it continues to work with the Biosafety and Biosecurity Coordinating Council to establish a process for the routine reporting of these results but had not yet completed its actions. As of September 2019 we had not received an update from HHS on the status of CDC's implementation of this recommendation.

Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Health and Human Services should develop department policies for managing hazardous biological agents in high-containment laboratories that contain specific requirements for training and inspections for all high-containment component agency laboratories and not just for their select-agent-registered laboratories; or direct the Director of CDC to provide these requirements in agency policies.

Agency: Department of Health and Human Services
Status: Open

Comments: In August 2016, HHS reported that CDC plans to revise its policies to include training and inspection requirements for inspections for all high-containment laboratories but did not provide an anticipated completion date. In June 2017, HHS reported that CDC was in the process of revising its formal policies to ensure they included requirements for training and inspections for all of the agency's high-containment laboratories but did not provide an anticipated completion date. In December 2017, HHS reported that CDC's policies were in the initial stages of the clearance process and anticipated they would be finalized in fall 2018. As of September 2019, HHS had not provided an update on the status of these policies.

Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Health and Human Services should require routine reporting of the results of agency and select agent laboratory inspections to senior department officials.

Agency: Department of Health and Human Services
Status: Open

Comments: In August 2016, HHS reported that CDC was working with FDA and NIH to establish a process for notifying HHS leadership of inspection results through the department's Biosafety and Biosecurity Coordinating Council. HHS did not provide us with an anticipated time frame for implementing this notification practice or when the agencies plan to begin notifying HHS of inspection results. In August 2019, FDA reported that it continues to work with the Biosafety and Biosecurity Coordinating Council to establish a process for the routine reporting of these results but had not yet completed its actions. As of September 2019, HHS had not provided an update on the status NIH's actions.

Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Health and Human Services should direct the Director of NIH and the Commissioner of FDA to require routine reporting of the results of agency laboratory inspections--and in the case of FDA, require routine reporting of select agent inspection results--to senior agency officials.

Agency: Department of Health and Human Services
Status: Open

Comments: In August 2016, HHS reported that NIH's ongoing practice is to report the results of external inspections to senior agency officials and, in May 2016, developed a standard operating procedure that outlines this reporting process. In March 2017, NIH officials provided assurance that its Division of Occupational Safety and Health provides NIH's intramural governing body with information about NIH's safety performance at least annually; officials further assured that this information includes the overall results of annual inspections (or audits, as NIH calls them) of all NIH laboratories and discussion of the top 10 most report safety infractions for the year. GAO considers NIH to have implemented the recommended action. GAO will close the overall recommendation once FDA has taken equivalent, appropriate action. As of August 2019, FDA reported that the agency began piloting a standardized agency-wide laboratory safety inspection checklist to ensure that all laboratories are inspected rigorously and consistently. As part of the pilot, all laboratories were to be inspected during the first 3 quarters of the calendar year. The agency said it planned to aggregate the results of the inspections, and trends and significant findings would be reported to FDA senior leadership in the fourth quarter of 2019. GAO will continue to monitor FDA's actions to implement this recommendation.

Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Health and Human Services should require routine reporting of incidents at CDC, FDA, and NIH laboratories to senior department officials.

Agency: Department of Health and Human Services
Status: Open

Comments: In August 2016, HHS reported that its Biosafety and Biosecurity Council was working to establish incident reporting requirements for CDC, FDA, and NIH but did not provide an anticipated completion date. HHS noted that NIH formally adopted a standard operating procedure that lays out the agency's requirements for reporting incidents to senior officials. In August 2019, FDA reported that it continues to work with the Biosafety and Biosecurity Coordinating Council to establish a process for the routine reporting of these results but had not yet completed its actions. As of September 2019, HHS had not provided an update on the status of NIH or CDC actions.

Recommendation: The Secretary of Veterans Affairs should direct the Under Secretary for Health to monitor the full amount of time newly enrolled veterans wait to be seen by primary care providers, starting with the date veterans request they be contacted to schedule appointments. This could be accomplished, for example, by building on the data collection efforts currently being implemented under the "Welcome to VA" program.

Agency: Department of Veterans Affairs
Status: Open
Priority recommendation

Comments: In March 2016, GAO recommended that VA monitor the full amount of time newly enrolled veterans wait to be seen by primary care providers, starting with the date veterans request they be contacted to schedule appointments. VA concurred with this recommendation, and in June 2017, reported to GAO that it had taken actions to address it. Specifically, VA indicated that it revised an internal report to help identify and document all newly enrolled veterans and monitor their appointment request status. The report is intended to enable VHA and its medical centers to oversee the enrollment and appointment process by tracking the following timeframes: (1) application to enrollment, (2) enrollment to initial contact, (3) initial contact to primary care appointment, and (4) total time from application to primary care appointment. However, VA also indicated in its response that it did not have data that captures application dates for all newly enrolled veterans. As such, the report could not be used to consistently monitor the full amount of time these veterans wait to be seen by primary care providers. In January 2018, VA reported developing and implementing technical enhancements to its electronic systems that will enable it to capture the application date for all newly enrolled veterans. In April 2018 and December 2018, VA reported making continued efforts to implement technical enhancements to its electronic system. In its February 2020 update, VA identified several steps that the agency was completing to fully implement the revised internal report and noted that following a successful piloting of the report, the agency would implement it system-wide. VA reported that it expects to fully address this recommendation by October 2020.

Recommendation: To help determine whether current efforts are effective or if additional action may be needed, such as development of a workplace violence prevention standard for health care employers, the Secretary of Labor should direct the Assistant Secretary for Occupational Safety and Health to develop and implement cost-effective ways to assess the results of the agency's efforts to address workplace violence.

Agency: Department of Labor
Status: Open
Priority recommendation

Comments: According to OSHA officials, the agency had a study underway to review OSHA's workplace violence enforcement cases in health care to better understand the obstacles OSHA compliance officers encountered during these investigations and identify factors which led to citations. The study was intended to help compliance officers develop citations in workplace violence cases. In addition, in December 2016, OSHA published a Request for Information on Preventing Workplace Violence in Healthcare and Social Assistance (RFI) to help identify workplace violence prevention requirements that could be effective and economical if a regulation were to be developed. OSHA reported in June 2018 that it is evaluating the information it received in response to the RFI and is gathering information on best practices in certain industries. As of April 2020, OSHA completed its review of the submissions in response to the RFI, is developing regulatory options, and will obtain additional input from potentially affected small businesses. The agency anticipates completing this process by the end of 2020. To fully implement this recommendation, the agency should complete its process of obtaining input on the regulatory options the agency is developing, and finalize its determination on whether regulatory action is needed.

Recommendation: To ensure that all BIE schools are positioned to address safety and health problems with their facilities and provide student environments that are free from hazards, the Secretary of the Interior should direct the Assistant Secretary-Indian Affairs to develop a plan to build schools' capacity to promptly address safety and health problems with facilities. Such a plan could prioritize assistance to schools to improve the expertise of facility staff to maintain and repair school buildings.

Agency: Department of the Interior
Status: Open
Priority recommendation

Comments: Interior agreed with this recommendation. In June 2018, Indian Affairs provided us with documentation on its efforts to build schools' capacity to address safety and health problems with facilities. In particular, the agency updated its Service Level Agreement between BIA and BIE, which details their roles and responsibilities for inspecting and providing technical assistance to BIE schools, among other areas. However, Indian Affairs' documents provided little information on how it planned to support BIE school personnel in fixing safety hazards in their facilities. In our 2016 report, we found that school personnel often lack the necessary technical expertise, time, and resources to address safety hazards in school buildings. Further, the agency did not include information on whether it has staffed regional offices with specialists to assist schools with safety and facility issues. In February 2020, agency officials said that they had not taken further actions to implement the recommendation and indicated that no office or official was currently responsible for coordinating efforts to implement the recommendation.

Recommendation: To better oversee the efficacy of PPACA's enrollment control process; to better monitor costs, risk, and program performance; to assist with tax compliance; to strengthen the eligibility determination process; to provide applicants with improved customer service and up-to-date information about submission of eligibility documentation; and to better document agency activities, the Secretary of Health and Human Services should direct the Acting Administrator of CMS to track the value of advance premium tax credit and cost-sharing reduction (CSR) subsidies that are terminated or adjusted for failure to resolve application inconsistencies, and use this information to inform assessments of program risk and performance. (See related recommendation 7.)

Agency: Department of Health and Human Services
Status: Open
Priority recommendation

Comments: In April 2016, HHS reported it considers this recommendation closed because it expanded the use of analytics to analyze the value of premium tax credit and CSR subsidies that are eliminated or adjusted for 2015 actions at the policy level, and that CMS continues to analyze the data to develop future operations changes. In May 2016, we requested documentation of these actions, including (1) information produced using the capability described; (2) ways in which this information is being used for analysis for purposes such as program operations, monitoring, risk assessment, or fraud cleaning; and (3) a description of the future operational changes contemplated based on the analyses done. However, as of December 2018, HHS officials had not provided GAO with evidence that the agency had implemented this recommendation. GAO said it would continue to monitor the agency's progress in this area. In March 2019, CMS reversed its initial concurrence with the recommendation, citing inability to obtain necessary data from another agency and a legal opinion on CSR subsidies. GAO kept the recommendation open, saying the developments HHS cited were irrelevant. In December 2019, after HHS reiterated its non-concurrence, GAO continued to maintain the recommendation as open.

Recommendation: To better oversee the efficacy of PPACA's enrollment control process; to better monitor costs, risk, and program performance; to assist with tax compliance; to strengthen the eligibility determination process; to provide applicants with improved customer service and up-to-date information about submission of eligibility documentation; and to better document agency activities, the Secretary of Health and Human Services should direct the Acting Administrator of CMS to, in the case of CSR subsidies that are terminated or adjusted for failure to resolve application inconsistencies, consider and document, in conjunction with other agencies as relevant, whether it would be feasible to create a mechanism to recapture those costs, including whether additional statutory authority would be required to do so; and for actions determined to be feasible and reasonable, create a written plan and schedule for implementing them.

Agency: Department of Health and Human Services
Status: Open

Comments: As of December 2018, CMS officials said the Department of Health and Human Services (HHS) had received a legal opinion from the U.S. Attorney General regarding validity of CSR payments, which prompted the agency to halt the payments as of October 2017. CMS officials said that if the recommendation were to be implemented, it would amount to creating new rules and a process for a program feature that no longer exists. However, in January 2019, HHS indicated that the administration supports a legislative solution that would appropriate CSR payments, and GAO continues to monitor for relevant legislative action. If funding becomes available to restore CSR payments, then implementing this recommendation would aid CMS in reducing improper payments. In December 2019, CMS reversed its initial concurrence with the recommendation, citing the legal opinion. GAO, however, continued to maintain the recommendation as open.

Recommendation: To better oversee the efficacy of PPACA's enrollment control process; to better monitor costs, risk, and program performance; to assist with tax compliance; to strengthen the eligibility determination process; to provide applicants with improved customer service and up-to-date information about submission of eligibility documentation; and to better document agency activities, the Secretary of Health and Human Services should direct the Acting Administrator of CMS to identify and implement procedures to resolve Social Security number inconsistencies where the Marketplace is unable to verify Social Security numbers or applicants do not provide them.

Agency: Department of Health and Human Services
Status: Open
Priority recommendation

Comments: In April 2016, HHS reported that it considered this recommendation open and was working on implementing functionality for updating consumers' Social Security numbers (SSN) and their eligibility based on the correct SSN. HHS reported that is it targeting deployment of the SSN update functionality in 2017. However, as of December 2018, HHS officials had not provided GAO with evidence that the agency had implemented this recommendation. In December 2019, HHS told GAO it continues to evaluate steps necessary to implement the recommendation, and expects close-out by October 2020. We will continue to monitor the agency's progress in this area.

Recommendation: To better oversee the efficacy of PPACA's enrollment control process; to better monitor costs, risk, and program performance; to assist with tax compliance; to strengthen the eligibility determination process; to provide applicants with improved customer service and up-to-date information about submission of eligibility documentation; and to better document agency activities, the Secretary of Health and Human Services should direct the Acting Administrator of CMS to reevaluate CMS's use of Prisoner Update Processing System (PUPS) incarceration data and make a determination to either (a) use the PUPS data, among other things, as an indicator of further research required in individual cases, and to develop an effective process to clear incarceration inconsistencies or terminate coverage, or (b) if no suitable process can be identified to verify incarceration status, accept applicant attestation on status in all cases, unless the attestation is not reasonably compatible with other information that may indicate incarceration, and forego the inconsistency process.

Agency: Department of Health and Human Services
Status: Open
Priority recommendation

Comments: In April 2016, HHS reported it considers this recommendation closed because in 2015, it made the determination to no longer require application filers to submit documentation regarding incarceration status. We were aware of that determination, but the recommendation was to reevaluate use of PUPS from the specific standpoint of using the data as it was intended to be used as in indicator of further research and then draw a conclusion on the use of the data. In May 2016, we requested documentation demonstrating that in the period since we made this recommendation, CMS has undertaken the reevaluation in the fashion that we indicated. As of December 2018, HHS officials had not provided GAO with evidence that the agency had implemented this recommendation. In December 2019, HHS told GAO it continues to evaluate steps necessary to implement the recommendation, and expects close-out by October 2021. We will continue to monitor the agency's progress in this area.

Recommendation: To better oversee the efficacy of PPACA's enrollment control process; to better monitor costs, risk, and program performance; to assist with tax compliance; to strengthen the eligibility determination process; to provide applicants with improved customer service and up-to-date information about submission of eligibility documentation; and to better document agency activities, the Secretary of Health and Human Services should direct the Acting Administrator of CMS to create a written plan and schedule for providing Marketplace call center representatives with access to information on the current status of eligibility documents submitted to CMS's documents processing contractor.

Agency: Department of Health and Human Services
Status: Open
Priority recommendation

Comments: In April 2016, HHS reported that since May 2015, call center representatives have received daily updates on the status of eligibility documentation. HHS reported that it is working to provide call center representatives with real-time data. HHS reported it considers this February 2016 recommendation to be closed. In May 2016, GAO noted that its February 2016 recommendation was focused on providing such real-time capability and requested (1) confirmation that call center representatives currently have on-demand, real-time access to up-to-date, application-level document status; and documentation showing development and implementation of this capability; or (2) a written plan and schedule for providing this capability as recommended. However, as of December 2018, HHS officials had not provided GAO with evidence that the agency has implemented this recommendation. In December 2019, the agency provided new evidence in support of closure, for which GAO requested supporting information. We will continue to monitor the agency's progress in this area.

Recommendation: To better oversee the efficacy of PPACA's enrollment control process; to better monitor costs, risk, and program performance; to assist with tax compliance; to strengthen the eligibility determination process; to provide applicants with improved customer service and up-to-date information about submission of eligibility documentation; and to better document agency activities, the Secretary of Health and Human Services should direct the Acting Administrator of CMS to fully document prior to implementation, and have readily available for inspection thereafter, any significant decision on qualified health plan enrollment and eligibility matters, with such documentation to include details such as policy objectives, supporting analysis, scope, and expected costs and effects.

Agency: Department of Health and Human Services
Status: Open
Priority recommendation

Comments: In April 2016, HHS reported it considers this recommendation closed because CMS prepares an annual Marketplace and Related Programs Cycle Memo to fulfill reporting requirements for internal control. The Memo describes all significant eligibility and enrollment policy and process changes, including new internal key controls associated with these changes, and the 2015 Memo was released in September 2015. In May 2016, we notified HHS that its actions do not close the recommendation. Information contained in the Memos is after-the-fact and while useful, does not meet the full range of documentation contemplated by our recommendation, especially development and analysis of changes prior to implementation. As of December 2018, HHS officials had not provided GAO with evidence that the agency has implemented this recommendation. In December 2019, HHS reversed its initial concurrence with the recommendation and said it would provide additional information on that decision. We will continue to monitor the agency's progress in this area.

Recommendation: To promote consistency in the distribution of supplemental payments among states and with CMS policy, the Administrator of CMS should issue written guidance clarifying its policy that requires a link between the distribution of supplemental payments and the provision of Medicaid-covered services.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open
Priority recommendation

Comments: CMS issued a proposed rule in November 2019 that may address this issue. According to the agency, the rule will promote state accountability, improve federal oversight, and strengthen the fiscal integrity of Medicaid. Specifically, the agency said the rule would require states to report to CMS a comprehensive description of the methodology used to calculate the amount and distribution of supplemental payments and the provider metrics used to calculate payment amounts, such as Medicaid utilization or costs. We will assess the extent to which the final rule addresses our recommendation when it is issued.

Recommendation: To promote consistency in the distribution of supplemental payments among states and with CMS policy, the Administrator of CMS should issue written guidance clarifying its policy that payments should not be made contingent on the availability of local funding.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open
Priority recommendation

Comments: CMS issued a proposed rule in November 2019 that may address this issue. According to the agency, the rule will promote state accountability, improve federal oversight, and strengthen the fiscal integrity of Medicaid. Specifically, the proposed rule clarifies the agency policy that Medicaid payments may not be contingent on the availability of local funding, according to agency officials. We will assess the extent to which the final rule addresses our recommendation when it is issued.

Recommendation: The Secretary of the Department of Health and Human Services should direct the Office of Refugee Resettlement to develop a process to ensure all information collected through its existing post-release efforts are reliable and systematically collected so that they can be compiled in summary form and provide useful information to other entities internally and externally.

Agency: Department of Health and Human Services
Status: Open

Comments: In March of 2016, the Office of Refugee Resettlement (ORR) created a new section in its unaccompanied children's policy guide that require ORR staff to make safety and well-being (SWB) follow-up calls to children and their sponsors after the child is release from ORR custody. In addition, in October of 2016, ORR added another section to its policy guide that included case reporting, records management, retention, and information sharing requirements for post-release service (PRS) providers. According to ORR officials, ORR collects and analyzes data from both its SWB calls and PRS providers. SWB call data include efforts made to contact both sponsor and child; participation rates; confirmation the child is currently residing with the sponsor; referrals made to the ORR National Call Center (NCC) for additional resources; any concerns regarding the child's safety and well-being; and whether any reports were made to the ORR Federal Field Specialist, child protective services, local law enforcement, and/or the ORR Sexual Abuse Hotline. PRS data include the reason for referral; level of services provided; services areas accessed by the child and/or sponsor; outcomes; any concerns regarding the child's safety and well-being; and when services were discontinued, according to ORR officials. According to ORR officials, because ORR is currently in the process of developing a new case management system, the majority of information from SWB calls and post-release efforts is collected manually, outside of ORR's current case management system. Information collected through ORR's SWB calls is aggregated quarterly and a fact sheet containing aggregate data is distributed internally to ORR leadership. ORR officials say the new case management system will include information on SWB calls and post-release efforts. ORR tentatively plans for the first phase of the system to be operational by November 2020 and to deploy a finished product with all planned enhancements in late 2021. GAO will close this recommendation once ORR completes this system and demonstrates that it can be used for the purpose of collecting reliable safety and well-being and post-release services data and disseminating it internally and externally, as appropriate.

Recommendation: To ensure states have appropriate and current guidance to assist them in designing and administering Medicaid NEMT, the Secretary of HHS should direct CMS to assess current Medicaid NEMT guidance and update that guidance as needed.

Agency: Department of Health and Human Services
Status: Open

Comments: As of July 2019, HHS officials reported that they are waiting for a policy decision from leadership concerning non-emergency medical transportation. GAO will continue to monitor and update the status of this recommendation.

Recommendation: The Secretary of Defense should direct the Secretary of the Army to implement processes to review and monitor the Army military treatment facility prescribing practices for medications discouraged under the PTSD guideline and address identified deviations.

Agency: Department of Defense
Status: Open

Comments: DOD concurred with this recommendation and stated that any policy that it may issue related to the monitoring of prescribing practices would be directed toward all of the military services. In May 2018 DOD stated that it planned to (1) conduct a comprehensive review of existing prescribing practices for the treatment of PTSD; (2) develop policy guidance for addressing prescribing practices for the management of PTSD that deviate from the clinical practice guideline; and (3) implement an automated dashboard that will flag medications that the PTSD guideline discourages from use. In its February 26, 2020 response, DOD stated that July 30, 2020 is the estimated completion date for these planned actions. To close this recommendation, DOD needs to implement its planned actions and provide documentation showing that the Department is monitoring medications discouraged from use under the PTSD guideline and addressing identified deviations.

Recommendation: In order to prevent the shift of services from physician offices to HOPDs from increasing costs for the Medicare program and beneficiaries, Congress should consider directing the Secretary of HHS to equalize payment rates between settings for E/M office visits--and other services that the Secretary deems appropriate--and to return the associated savings to the Medicare program.

Agency: Congress
Status: Open

Comments: The Bipartisan Budget Act of 2015, enacted in November 2015, partially addressed our recommendation as it limits certain providers from billing at higher hospital outpatient department payment rates. Specifically, the legislation excludes services furnished by off-campus hospital outpatient departments from reimbursement under Medicare's hospital outpatient prospective payment system, effective January 1, 2017. According to the Congressional Budget Office, this action saves the Medicare program $9.3 billion over 10 years. However, the Act does not apply to services furnished by providers billing as hospital outpatient departments prior to enactment of the legislation-which includes providers billing as hospital outpatient departments during the study period in our report-as well as hospital outpatient departments located on hospital campuses. This means that, even in 2017 and beyond, many providers will not be affected by the Act, and Medicare will continue to pay more than necessary for certain services. In November 2018, CMS issued a final rule adopting payment changes-that have since been partially overturned under a decision by a federal district court, which CMS has appealed-capping payment rates for certain services furnished by the off-campus hospital outpatient departments that existed or were under construction in 2015 at the physician fee schedule rate. Since these services furnished by these off-campus hospital outpatient departments were paid under a higher rate, the payment cap, which was to be implemented over 2 years, was intended to equalize payment rates for certain clinical visits between settings. In 2019, CMS applied 50 percent of the payment reduction and in 2020 and subsequent years planned to apply 100 percent of the payment reduction. The rule applied to specific clinical visits; and other services would continue to be paid at the higher rate. However, a federal district court overturned the payment cap in September 2019. CMS has appealed that ruling and adopted a final rule in November 2019 that will implement the payment reduction in 2020. A lawsuit challenging the November 2019 final rule has been filed.

Recommendation: To help improve the U.S. aviation sector's preparedness for future communicable disease threats from abroad, the Secretary of Transportation should work with relevant stakeholders, such as the Department of Health and Human Services, to develop a national aviation-preparedness plan for communicable disease outbreaks. Such a plan could establish a mechanism for coordination between the aviation and public health sectors and provides clear and transparent planning assumptions for a variety of types and levels of communicable disease threats.

Agency: Department of Transportation
Status: Open
Priority recommendation

Comments: The Department of Transportation (DOT) has not developed a national aviation-preparedness plan to respond to communicable disease threats from abroad. In June 2020, we urged Congress to take legislative action to require the Secretary of Transportation to work with relevant agencies and stakeholders to develop a national aviation-preparedness plan to limit the spread of communicable disease threats, and minimize travel and trade impacts (see GAO-20-625). GAO's periodic updates on the CARES Act of 2020 provide information about actions taken by Congress to address this matter. DOT partially concurs with our recommendation and agrees that an aviation preparedness plan is needed, but continues to suggest that the Department of Health and Human Services (HHS) and the Department of Homeland Security (DHS) have responsibility for communicable disease response and preparedness planning, respectively, and that these departments should lead any efforts to address planning for communicable disease outbreaks, including for transportation. In the absence of a national aviation-preparedness plan, DOT officials point to ongoing efforts to engage with interagency partners at DHS and HHS, as well as industry stakeholders, to better collaborate on communicable disease response and preparedness as they relate to civil aviation. For example, in July 2020, DOT, HHS, and DHS issued guidance to airports and airlines for implementing measures to mitigate public health risks associated with COVID-19. While this guidance is a positive step, DOT has not yet taken action to develop an aviation preparedness plan for future communicable disease threats that incorporate such things as protocols for responding to the threat and coordination among stakeholders.

Recommendation: To improve the data on tracked safety issues and postmarket studies that are needed for required reporting and for systematic oversight of postmarket drug safety, the Secretary of HHS should direct the Commissioner of FDA to work with stakeholders within FDA to identify additional improvements that could be made to FDA's current database or future information technology investments to capture information in a form that can be easily and systematically used by staff for oversight purposes.

Agency: Department of Health and Human Services
Status: Open

Comments: FDA has made changes intended to improve its process for overseeing tracked safety issues, but as of August 2020, FDA was still working on changes to its process for postmarket study data. For tracked safety issues, FDA held a one-day workshop to solicit input from staff on changes to its tracked safety issue process and collect user requirements for a new IT system to support tracking safety issues. In April 2020, FDA finalized new policies and procedures and implemented a new IT system for tracking safety issues. The new IT system allows anyone within FDA's Center for Drug Evaluation and Research to enter new safety signals and has integrated product and adverse event dictionaries. FDA stated that integrating standardized data will support consistent regulatory decisions and improve the quality of analysis. For postmarket studies, FDA has indicated that it intends to formally assess the IT needs of users as part of the planned transfer of postmarket data to its new informatics platform. As of August 2020, FDA anticipated creating a project team to address specific concerns related to postmarket study data by the end of calendar year 2020 or the beginning of calendar year 2021. GAO is keeping this recommendation open until FDA has completed its planned improvements to its process for tracking postmarket study data.

Recommendation: To ensure that HHS workforce efforts meet national needs, the Secretary of Health and Human Services should develop a comprehensive and coordinated planning approach to guide HHS's health care workforce development programs--including education, training, and payment programs--that (1) includes performance measures to more clearly determine the extent to which these programs are meeting the department's strategic goal of strengthening health care; (2) identifies and communicates to stakeholders any gaps between existing programs and future health care workforce needs identified in the Health Resources and Services Administration's workforce projection reports; (3) identifies actions needed to address identified gaps; and (4) identifies and communicates to Congress the legislative authority, if any, the Department needs to implement the identified actions.

Agency: Department of Health and Human Services
Status: Open

Comments: In December 2016, HHS indicated that the agency had not yet taken steps to implement a comprehensive workforce planning effort. Officials said that for the FY2018 cycle, HHS had planned to expand its group developing legislative proposals to include budget issues and gaps that warrant attention. While it did not do so during that cycle, officials indicated that they would recommend this broader approach to workforce planning for future budget and legislative cycles. In an update presented in HHS's FY2021 budget justification, HHS did not address efforts to develop a comprehensive and coordinated planning approach to guide HHS's health care workforce development programs. Instead, it described its current legislative and budget development effort and proposal to restructure CMS Graduate Medical Education (GME) programs into a discretionary grant program. It noted that such a restructuring would allow the Department to set expectations for program performance in CMS GME and allow the kind of tracking HRSA has been able to implement in the Children's Hospital GME program and its Teaching Hospital GME program. It noted that Congress had not responded to this request. However, this recommendation stands on its own and is separate from any legislative efforts to modify how federal GME funds are distributed. Whether or not legislation is enacted to implement a consolidated federal GME grant program, HHS should take action to develop a comprehensive and coordinated planning approach. Such action is important for HHS to assure that federal programs fully meet workforce needs. Further, the CARES Act of 2020 requires HHS to develop a comprehensive and coordinated strategic plan for HHS health workforce programs. We will be monitoring HHS's implementation of this requirement to determine if it satisfies the intent of this recommendation.

Recommendation: To improve the effectiveness of its oversight of eligibility determinations, the Administrator of CMS should conduct reviews of federal Medicaid eligibility determinations to ascertain the accuracy of these determinations and institute corrective action plans where necessary.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: The Department of Health and Human Services (HHS) has taken some steps to improve the accuracy of Medicaid eligibility determinations, as GAO recommended in October 2015, but has not yet conducted a systematic review of federal eligibility determinations. In July 2017, HHS issued its final rule on the Payment Error Rate Measurement (PERM) program, and stated that it would include reviews of federal eligibility determinations in states that have delegated that authority. In December 2017, HHS provided information noting that the first cycle of the revised PERM includes two states where there were federal eligibility determinations. However, as HHS confirmed in December 2019, the random sample of eligibility determinations reviewed in the first cycle of the revised PERM did not include any federal eligibility determinations. As such, the PERM has not systematically reviewed federal determinations, and we maintain that further reviews are needed to help ensure that only individuals eligible for Medicaid are receiving benefits. We will continue to monitor HHS to determine if HHS is ascertaining the accuracy of federal eligibility determinations and taking corrective action where necessary.

Recommendation: To determine the extent to which Medicare payments are aligned with costs for specific types of dialysis treatment and training, the Administrator of CMS should take steps to improve the reliability of the cost report data for treatment and training associated with specific types of dialysis.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: As of February 2020, CMS has not implemented this recommendation. HHS agreed with this recommendation and stated in February 2020 that CMS was exploring ways to clarify the cost report instructions in an effort to improve the accuracy of the information submitted. We will update the status of this recommendation when we receive additional information.

Recommendation: To ensure that patients with chronic kidney disease receive objective and timely education related to this condition, the Administrator of CMS should examine the Kidney Disease Education benefit and, if appropriate, seek legislation to revise the categories of providers and patients eligible for the benefit.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: As of February 2020, CMS has not implemented this recommendation. HHS did not agree with this recommendation and stated in June 2016 that CMS continuously works to pay appropriately for ESRD services and must prioritize its activities to improve care for dialysis patients. While we acknowledge the need for CMS to prioritize its activities to improve dialysis care, it is important for CMS to help ensure that Medicare patients with chronic kidney disease understand their condition, how to manage it, and the implications of the various treatment options available, particularly given the central role of patient choice in dialysis care. The limited use of the Kidney Disease Education benefit that we noted in our report suggests that it may be difficult for Medicare patients to receive this education and underscores the need for CMS to examine and potentially revise the benefit. We will update the status of this recommendation when we receive additional information.

Recommendation: To improve its oversight of network adequacy in MA, the Administrator of CMS should augment MA network adequacy criteria to address provider availability.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS concurred with this recommendation, and noted in a February 2018 update that CMS requires MAOs to identify provider availability in certain circumstances, such as in granting exceptions to the agency's network adequacy criteria. CMS also stated that it would consider augmenting MA network adequacy criteria to address provider availability in future years. However, CMS's 2018 MA network adequacy guidance stated that the agency does not currently consider provider availability when reviewing an organization's network adequacy, and this guidance was not updated in 2019. As a result, as of September 2019, agency officials have not implemented this recommendation.

Recommendation: To improve its oversight of network adequacy in MA, the Administrator of CMS should verify provider information submitted by MAOs to ensure validity of the Health Services Delivery data.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS concurred with this recommendation, and noted in a February 2018 update that the agency has standardized existing protocols to ensure the validity of the Health Services Delivery data submitted by MAOs with regards to exceptions requests and partial county justifications. However, CMS's 2018 MA network adequacy guidance stated that MAOs remain responsible for conducting validation of Health Services Delivery data. Unless CMS verifies provider information submitted by MAOs, the agency cannot be confident that MAOs are meeting network adequacy criteria. As of September 2019, agency officials have not implemented this recommendation.

Recommendation: To improve its oversight of network adequacy in MA, the Administrator of CMS should set minimum requirements for MAO letters notifying enrollees of provider terminations and require MAOs to submit sample letters to CMS for review.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS concurred with this recommendation. In a September 2017 update, the agency stated that it had met the spirit of our recommendation by adding its best practice suggestions of what should be included in the written termination notice to the Medicare Managed Care Manual. However, as we noted in our report, those practices are not required, nor are the letters regularly reviewed. As of September 2019, agency officials have not yet implemented this recommendation.

Recommendation: To strengthen oversight of the individual shared responsibility and premium tax credit provisions, the Commissioner of Internal Revenue should assess whether or not the data received from the health insurance marketplaces are sufficiently complete and accurate to enable effective correction of tax returns at-filing based on matching with the marketplace data and, if the assessment determines that such corrections would be effective, seek legislative authority to correct tax returns at-filing based on the marketplace data.

Agency: Department of the Treasury: Internal Revenue Service
Status: Open

Comments: The Internal Revenue Service (IRS) agreed with GAO's recommendation. IRS reports that the quality of data submitted by health insurance marketplaces has improved since the 2015 return filing season, and it continues to use its correspondence process for resolving discrepancies between marketplace data and that reported by the taxpayer after the return has been filed. IRS has not considered requesting legislative authority to correct tax returns at the time of filing based specifically on discrepancies between the data submitted by the health insurance marketplace and reported by the taxpayer. Agency officials believe that would be premature at this time. They noted that a broader legislative initiative has already been proposed that would grant IRS with correctable error authority in cases where the information provided by the taxpayer does not match the information contained in government databases. Should this broad authority be granted in the future, IRS will then consider how to approach correction of tax returns at the time of filing based on discrepancies with health insurance marketplace data. Such authority was also included in the Administration's 2021 budget.

Recommendation: To strengthen oversight of the individual shared responsibility and premium tax credit provisions, the Commissioner of Internal Revenue should evaluate IRS efforts to collaborate and communicate with key external stakeholders to inform efforts related to implementation of the new 2015 PPACA requirements.

Agency: Department of the Treasury: Internal Revenue Service
Status: Open

Comments: The Internal Revenue Service (IRS) agreed with GAO's recommendation but has not yet initiated an evaluation of collaboration and communication efforts with external stakeholders. IRS currently utilizes informal feedback processes to share information and identify opportunities for improvement with external stakeholders in implementing the shared responsibility payment and premium tax credit provisions. We continue to encourage IRS to evaluate its collaboration and communication efforts, but such an evaluation has not yet happened. We will continue to monitor IRS efforts.