Recommendation: The Secretary of Health and Human Services should ensure that the agency uses a spend analysis on a regular basis to identify IT contract duplication. (Recommendation 8)

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 OHS Director should require Head Start grantees to document that water provided to children has been tested for lead. OHS could determine various ways that are feasible and efficient for grantees to satisfy this requirement; for example, verification could be done through OHS' current grantee data collection or monitoring processes. (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 Assistant Secretary for the Administration for Children and Families should direct OCC and OHS to develop an agreement with EPA on their roles and responsibilities in implementing the Memorandum of Understanding on Reducing Lead Levels in Drinking Water in Schools and Child Care Facilities. For example, these agreements may include the ways in which guidance and information will be shared with states and Head Start grantees, such as through webinars or email, and how frequently. (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 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 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 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 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 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 Director of ORR should clarify in its grant announcements the information and supporting documentation applicants are required to provide in their grant applications with respect to their state licensing status, eligibility, and allegations and concerns. (Recommendation 1).

Agency: Department of Health and Human Services: Administration for Children and Families: Office of Refugee Resettlement
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 ORR should take steps to develop, and ensure that officials reviewing grant applications implement, a process to verify the accuracy and completeness of information reported by grant applicants on state licensing status, eligibility, allegations and concerns. (Recommendation 2).

Agency: Department of Health and Human Services: Administration for Children and Families: Office of Refugee Resettlement
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 ORR should ensure that the grant review process includes a documented review of applicants' past performance on ORR grants for those that have previously received grants to care for unaccompanied children. This could include, for example, a systematic review of previous quarterly and annual performance reports and a review of corrective actions issued by all ORR monitoring staff to all ORR-funded facilities previously operated by the applicant. (Recommendation 3).

Agency: Department of Health and Human Services: Administration for Children and Families: Office of Refugee Resettlement
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 ORR should clarify in its instructions to grantees the information they are required to report on state licensing citations in their quarterly performance reports. (Recommendation 4).

Agency: Department of Health and Human Services: Administration for Children and Families: Office of Refugee Resettlement
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 ORR should take steps, such as through guidance or training, to ensure that project officers clearly understand the requirement that grantees report state licensing citations at any of their facilities within 24 hours and include state licensing citations in their quarterly performance reports. (Recommendation 5).

Agency: Department of Health and Human Services: Administration for Children and Families: Office of Refugee Resettlement
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 ORR should work with state agencies that license ORR-funded facilities to develop a plan for mutual information sharing, including processes for ORR outreach to states during the grant application review process and ongoing information sharing on ORR and state monitoring processes and identified deficiencies. (Recommendation 6).

Agency: Department of Health and Human Services: Administration for Children and Families: Office of Refugee Resettlement
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 ORR should ensure that ORR provides and maintains a current point of contact for each state agency that licenses ORR grantees to facilitate information sharing regarding ORR-funded facilities. (Recommendation 7).

Agency: Department of Health and Human Services: Administration for Children and Families: Office of Refugee Resettlement
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 ORR should develop a plan—including roles, responsibilities, and timeframes—to guide and focus ORR's efforts to meet its goals to:

• conduct an audit of each facility's compliance with ORR standards on preventing and responding to sexual assault, as required under the Interim Final Rule,
• conduct on-site monitoring visits to each facility at least every 2 years in accordance with ORR policy, and
• report any noncompliance to the facility within 30 days of the site visit, in accordance with ORR policy.

(Recommendation 8).

Agency: Department of Health and Human Services: Administration for Children and Families: Office of Refugee Resettlement
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 the FDA should ensure that PAC renews its charter. (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 Director of NIH should establish and implement a policy requiring all FACA committees under NIH's jurisdiction to post meeting minutes online. (Recommendation 6)

Agency: Department of Health and Human Services: Public Health Service: National Institutes of Health
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 establish a process for the agency to communicate directly with all U.S.-based commercial airlines, including regional airlines, to encourage them to request construction inspections to ensure compliance with the agency's standards for the sanitary construction of aircraft galleys and lavatories. (Recommendation 1)

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

Comments: HHS concurs with GAO's recommendation. FDA agrees that enhancing communication with U.S.-based commercial airlines, including major national and regional commuter airlines, to encourage them to request construction inspections can have a positive impact on efforts to gain compliance with the Agency's standards for aircraft galley and lavatory sanitation and potable water system installation. FDA has a long history of working collaboratively with interstate travel conveyance stakeholders to provide public health oversight to the industry. As part of this collaboration, FDA and the airline industry connect through a variety of mechanisms to provide access to diverse industry partners. To effectively engage all relevant stakeholders, FDA will consider ways to enhance current mechanisms and coordinate with airlines on better communication. FDA will review its existing outreach channels to allow airline stakeholders to actively and directly engage with the Agency on construction inspections. FDA will review its Interstate Travel Program website to determine if updates can be made to emphasize airline construction and reconstruction information. FDA maintains open dialog with airline organizations, including the Airlines for America (A4A), the Regional Airline Association (RAA), and the International Flight Services Association (IFSA). Members of A4A are comprised of major national airlines, whereas those of RAA are comprised of regional commuter airlines and those in IFSA include airlines and airline food suppliers. These industry associations are valuable partners in developing solutions to problems that concern the airlines and airline construction. FDA will continue to engage with these organizations in written correspondence and at relevant national industry meetings (such as the Environmental Protection Agency biennial meeting on aircraft drinking water safety) and will include the topic of construction inspections. FDA will also continue to use these existing mechanisms to develop a better communication process with the airline industry on its efforts to improve industry practice and government oversight.

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 Director of IHS should document approved hardware inventory information by associating FISMA systems with the hardware on its network in a format that can be readily integrated into its CDM tools. (Recommendation 10)

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 Director of IHS should document agency-specific variations from federal core configuration benchmarks for each operating system on its network. (Recommendation 11)

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 Director of IHS should configure its CDM tools to compare configuration settings against federal core benchmarks applicable to its environment. (Recommendation 12)

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 Associate Commissioner of the Administration for Children and Families Children's Bureau within the Department of Health and Human Services should develop a process to assess the reliability of grantee performance information contained within annual performance reports for tribal recipients of its Stephanie Tubbs Jones Child Welfare Services Program. (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 Assistant Secretary for the Administration for Children and Families (ACF) should establish an ongoing process to proactively share information and best practices with states about programs it administers that are available to serve kin caregivers, especially in states with a relatively large share of grandparent caregivers. This could be achieved, for example, by leveraging regional office staff to provide additional assistance and information sharing, particularly related to kinship navigator programs. (Recommendation 1)

Agency: Department of Health and Human Services: Administration for Children and Families
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 for the Administration for Community Living (ACL) should establish an ongoing process to proactively share information and best practices with states about using National Family Caregiver Support Program (NFCSP) funds to serve older relative caregivers of children, especially in states with a relatively large share of grandparent caregivers. This could be achieved, for example, by leveraging regional office staff to share information from states and area agencies on aging that have successfully used this program to serve older relative caregivers. (Recommendation 2)

Agency: Department of Health and Human Services: Administration for Community Living
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 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: The Administrator of CMS should, in collaboration with OMB, solicit input from FBI, IRS, SSA, and state agency stakeholders on revisions to its security policy to ensure that cybersecurity requirements for state agencies are consistent with other federal agencies and NIST guidance to the greatest extent possible and document CMS's rationale for maintaining any requirements variances.(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 revise its assessment policies to maximize coordination with other federal agencies to the greatest extent practicable. (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 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 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 Secretary of HHS, in consultation with the Council on Economic Mobility, should make information that would assist state and local entities in developing and implementing two-generation poverty reduction approaches readily available across federal programs and offices. (Recommendation 1)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS agreed with this recommendation. The agency stated that through its coordination of the Council on Economic Mobility it will promote poverty reduction approaches that aim to provide more integrated, person-centered service delivery. It will also work to identify opportunities for collaboration, promising practices, and successful models that promote economic mobility and will develop strategies for promoting them, such as through technical assistance. We will monitor the progress of these efforts.

Recommendation: The Secretary of Health and Human Services should ensure that the agency's Chief Information Officer develops a policy that requires the agency's components to maintain an inventory of the telecommunications assets and services that they acquire independently from headquarters; updates the telecommunications inventory to include all telecommunications assets and services in use at HHS, and updates the agency's process for ongoing maintenance of the inventory to include the complete inventory. (Recommendation 6)

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

Comments: HHS concurred with this recommendation. We will continue to follow-up on the department's efforts to address it.

Recommendation: The Secretary of Health and Human Services should ensure that the agency's Chief Information Officer completes efforts to identify future telecommunications needs using a complete inventory of existing telecommunications services; and aligns HHS's telecommunications needs with its long-term IT plans. (Recommendation 7)

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

Comments: HHS concurred with this recommendation. We will continue to follow-up on the department's efforts to address it.

Recommendation: The Secretary of Health and Human Services should ensure that the agency's Chief Information Officer identifies and documents telecommunications transition roles and responsibilities related to (1) managing assets and human capital during the planning and execution phases of the transition and (2) providing legal expertise during the execution phase of the transition, and assigns the transition information security management role to a staff member; and establishes and implements configuration and change management processes for HHS's transition. (Recommendation 8)

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

Comments: HHS concurred with this recommendation. We will continue to follow-up on the department's efforts to address it.

Recommendation: The Secretary of Health and Human Services should ensure that the agency's Chief Information Officer identifies all of the funding needed to support the telecommunications transition at each of the agency's components, justifies requests for transition resources related to hardware and software upgrades, conducts an analysis to identify staff resources needed for the entire transition effort, and analyzes training needs for staff assisting with the transition. (Recommendation 9)

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

Comments: HHS concurred with this recommendation. We will continue to follow-up on the department's efforts to address it.

Recommendation: The Secretary of Health and Human Services should ensure that the agency's Chief Information Officer completes efforts to identify telecommunications transition measures of success that can be used to assess transition progress; and takes into account all of the agency's components, as well as its mission critical systems, contingency plans,and telecommunications transition risks, in HHS's transition time line. (Recommendation 10)

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

Comments: HHS concurred with this recommendation. We will continue to follow-up on the department's efforts to address it.

Recommendation: The Commissioner of the Food and Drug Administration, in coordination with the Secretary of Agriculture, should more fully incorporate the seven leading practices for effective collaboration in the agencies' interagency agreement for the joint oversight of cell-cultured meat. (Recommendation 1)

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

Comments: FDA and USDA partially concurred with this recommendation. FDA stated that it concurred with the intent of incorporating the seven leading practices into the interagency agreement, and both agencies said that they are open to incorporating the practices into their development of the structure for joint oversight of cell-cultured meat. However, the agencies stated that they did not agree to revise the agreement at this time. FDA and USDA stated that the agreement is a general framework and that incorporating the leading practices would constitute an inappropriate level of detail. Instead, the agencies stated that they believe it would be most valuable to incorporate the leading practices into a more detailed joint framework or standard operating procedure they plan to issue. We appreciate the agencies' willingness to incorporate the leading practices for effective collaboration into their efforts. The March 2019 interagency agreement states that the agencies have the ability to modify it as needed and will review the agreement every 3 years to determine whether they should modify or terminate it. Therefore, the agencies are due to revisit the agreement in March 2022, if not sooner. Regarding the agencies' concern that incorporating the leading practices in the interagency agreement would add an inappropriate level of detail, we note that, as we state in our report, the existing agreement already partially incorporates each of the seven leading practices. We continue to believe that FDA and USDA should more fully incorporate the seven leading practices for effective collaboration into their interagency agreement for the joint oversight of cell-cultured meat. Developing a more detailed joint framework or standard operating procedure in accordance with the existing interagency agreement that incorporates those leading practices would meet the intent of our recommendation to improve the effectiveness of the agencies' collaboration.

Recommendation: As the three cell-cultured meat working groups move forward, the Commissioner of the Food and Drug Administration, in coordination with the Secretary of Agriculture, should more fully incorporate the seven leading practices for effective collaboration, such as identifying specific outcomes and a way to monitor and evaluate progress toward outcomes. (Recommendation 3)

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

Comments: In March 2020, FDA officials agreed with this recommendation. We will follow up to determine what steps they take to implement the recommendation.

Recommendation: The Commissioner of the Food and Drug Administration, in coordination with the Secretary of Agriculture, should clearly document in their interagency agreement, or other publicly available document, which agency will oversee cell-cultured seafood other than catfish. (Recommendation 5)

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

Comments: In March 2020, FDA officials agreed with this recommendation. We will follow up to determine what steps they take to implement the recommendation.

Recommendation: The Secretary of Health and Human Services should document in policies and procedures HHS's improper payment corrective action plan process. As part of these procedures, HHS should include processes for (1) establishing planned completion dates, (2) monitoring the progress of implementing corrective actions, and (3) measuring the effectiveness of improper payment corrective actions. The process for measuring the effectiveness of corrective actions should clearly demonstrate the effect HHS's corrective actions have on reducing improper payments. (Recommendation 4)

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

Comments: In commenting on our draft report, HHS elaborated on the improper payment corrective action plan process that is called for in OMB guidance. HHS stated that OMB guidance provides agencies the flexibility to measure the effectiveness of corrective actions and believes that this flexibility is vital to its oversight processes to reduce improper payments.

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 Secretary of the Department of Health and Human Services should direct the Director for the Office for Civil Rights to publicize a stand-alone list of promising practices for Title IX compliance on its websites for their university grantees. (Recommendation 3)

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

Comments: HHS agreed with the recommendation. In its February 2020 formal comment letter, the department stated the Office for Civil Rights will incorporate effective practices from materials posted on its website and external sources in a stand-alone list of effective practices to help universities comply with Title IX. The Office for Civil Rights will also draw from its Title IX enforcement work to update the effective practices list on an ongoing basis.

Recommendation: The Secretary of the Department of Health and Human Services should direct the Director for the Office for Civil Rights to assess the feasibility of receiving and reviewing concerns of sex discrimination—including sexual harassment—and communicating to individuals on agency-funded grants the option to notify the agency of these concerns, outside of the Title IX complaint process. (Recommendation 7)

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

Comments: HHS agreed with the recommendation. In its February 2020 formal comment letter, the department stated that outside of the Title IX enforcement process, the Office for Civil Rights updated its sex discrimination web pages to inform persons on how to file complaints of discrimination directly to the Office for Civil Rights, including complaints of sexual harassment. The Office for Civil Rights has also incorporated information about Title IX rights and obligations in outreach material used on university campuses, including information addressing sexual harassment.

Recommendation: The Secretary of the Department of Health and Human Services should direct the Director for the Office for Civil Rights and the Director of NIH to develop and implement formal procedures for sharing relevant information about Title IX (compliance reviews, violations, and complaints) and sex discrimination concerns, including sexual harassment. For example, HHS components should internally share information regarding findings of Title IX violations, concerns of sex discrimination, including sexual harassment, and Title IX compliance review reports. (Recommendation 11)

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

Comments: HHS agreed with the recommendation. In its February 2020 formal comment letter, the department stated that the Office for Civil Rights and NIH will review the current procedure for sharing information, and development and implement (as necessary) formal procedures for sharing relevant information about Title IX and sexual harassment concerns. Furthermore, an action plan to address the recommendation will be provided in the department's 180-day letter response to Congress.

Recommendation: The Secretary of the Department of Health and Human Services should establish goals and an overall plan to assess all of the agency's sexual harassment prevention efforts for their university grantees, including methods to regularly monitor and evaluate its sexual harassment prevention policies and communication mechanisms (e.g. Title IX or sex discrimination websites). (Recommendation 13)

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

Comments: HHS agreed with the recommendation. In its February 2020 formal comment letter, the department stated that NIH has created goals for all NIH grantee sexual harassment prevention efforts, as noted in GAO's report. NIH will develop a plan to assess progress towards achieving those goals, including methods to regularly monitor and evaluate policies and communication methods. To the extent Title IX enforcement and outreach efforts may prevent sexual harassment, the Office for Civil Rights will develop a plan for leveraging enforcement efforts and outreach communications to help HHS grantees implement prevention efforts. HHS will submit an action plan that fully address department efforts regarding this recommendation in its 180-day letter response to Congress.

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 OCC should establish internal written policies to effectively implement and document the State Plan review and approval process for future review and approval periods. (Recommendation 1)

Agency: Department of Health and Human Services: Administration for Children and Families: Office of the Child Care Bureau
Status: Open

Comments: In September 2020, OCC told us it has been working on establishing written policies (e.g., internal guidance documents and checklists) to implement and document the State Plan review and approval process. OCC expects to complete this work for the FY2022-2024 Plan period. We will continue to monitor OCC's efforts to implement this recommendation.

Recommendation: The Director of OCC should define the informational needs related to the results of program-integrity activities. (Recommendation 2)

Agency: Department of Health and Human Services: Administration for Children and Families: Office of the Child Care Bureau
Status: Open

Comments: In September 2020, OCC told us that it is developing the next CCDF State/Territory Plan Preprint due for submission by states and territories July 1, 2021. According to OCC, it plans to incorporate its information needs regarding the results of program integrity into the Preprint document as it develops the document. We will continue to monitor OCC's progress in implementing this recommendation.

Recommendation: The Director of OCC should communicate externally to the states its informational needs related to the results of states' program-integrity activities. (Recommendation 3)

Agency: Department of Health and Human Services: Administration for Children and Families: Office of the Child Care Bureau
Status: Open

Comments: In September 2020, OCC told us that it is developing the next CCDF State/Territory Plan Preprint due for submission by states and territories July 1, 2021. According to OCC, it plans to communicate its information needs regarding the results of program integrity activities to states and territories as part of the Preprint Training activities - including webinars and peer-to-peer virtual meetings - so Lead Agencies understand what is expected for them to address in the CCDF Plan. We will continue to monitor OCC's progress in implementing this recommendation.

Recommendation: The Director of OCC should communicate internally to staff its informational needs related to the results of states' program-integrity activities. (Recommendation 4)

Agency: Department of Health and Human Services: Administration for Children and Families: Office of the Child Care Bureau
Status: Open

Comments: In September 2020, OCC told us that it is developing the next CCDF State/Territory Plan Preprint due for submission by states and territories July 1, 2021. According to OCC, it plans to communicate its information needs regarding the results of program integrity activities to staff in both regional and central offices as part of the Preprint Training activities so staff understand what is expected for Lead Agencies to address in the CCDF Plan. We will continue to monitor OCC's progress in implementing this recommendation.

Recommendation: The Director of OCC should develop documented criteria to guide the review of CAPs submitted by states to ensure that proposed corrective actions are aimed at root causes of improper payments and are effectively implemented. (Recommendation 5)

Agency: Department of Health and Human Services: Administration for Children and Families: Office of the Child Care Bureau
Status: Open

Comments: In September 2020, OCC told us it revised the CAP Review Tool to in response to our recommendation. OCC also told us that it plans to implement the revised CAP Review Tool beginning September 2020 to document the review of CAPs submitted for the most recent ACF-404 reporting cycle (June 2020). We asked OCC to provide documentation showing the revised CAP Review Tool is responsive to our recommendation. We will update this recommendation status after reviewing the documentation OCC provides.

Recommendation: The Director of OCC should timely complete its effort to develop established written policies for the CAP follow-up process to ensure that OCC's oversight and monitoring of CAPs is carried out consistently. (Recommendation 6)

Agency: Department of Health and Human Services: Administration for Children and Families: Office of the Child Care Bureau
Status: Open

Comments: In September 2020, OCC told us it developed draft written policies for the CAP follow-up process to ensure that OCC's oversight and monitoring of CAPs is carried out consistently. However, due to the impact of the COVID-19 on staffing capacity, OCC has not presented the draft policies to regional offices for feedback. OCC told us it plans to finalize the written policies for the CAP follow-up process by December 2020. We will continue to monitor OCC's progress in implementing this recommendation.

Recommendation: The Director of OCC should develop and document criteria to assess the effectiveness of states' program-integrity control activities. (Recommendation 7)

Agency: Department of Health and Human Services: Administration for Children and Families: Office of the Child Care Bureau
Status: Open

Comments: In September 2020, OCC told us it analyzed information gathered from federal and state resources to develop and document criteria to be used to assess the effectiveness of states' program integrity control activities. We asked OCC to provide us the document showing all criteria to be used to assess the effectiveness of states' program integrity control activities. We will update this recommendation status after reviewing the documentation OCC provides.

Recommendation: The Director of OCC should evaluate the feasibility of collecting information from the Grantee Internal Controls Self-Assessment Instrument (Self-Assessment Instrument) and Fraud Toolkit, such as during its Monitoring System process, to monitor the effectiveness of states' program-integrity control activities. (Recommendation 8)

Agency: Department of Health and Human Services: Administration for Children and Families: Office of the Child Care Bureau
Status: Open

Comments: In September 2020, OCC told us it is working to make the Self-Assessment Instrument and Fraud Toolkit more user-friendly to encourage increased use within the state CCDF program. With increased usage, OCC believes it will be in a better position to assess how the collection of data from these two instruments can be incorporated into the Onsite Monitoring System or other oversight activity. OCC told us it anticipates completing work to implement this recommendation by December 2020. We will continue to monitor OCC's progress in implementing this recommendation.

Recommendation: The Assistant Secretary for ACF should ensure that ACF conducts a fraud risk assessment to provide a basis for the documentation and development of an antifraud strategy that describes the CCDF program's approach to address prioritizing fraud risks identified. (Recommendation 9)

Agency: Department of Health and Human Services: Administration for Children and Families
Status: Open

Comments: In September 2020, HHS told us it anticipates completing the initial fraud risk assessment for the CCDF program by December 2020. We will continue to monitor HHS's efforts to implement this recommendation.

Recommendation: The Secretary of Health and Human Services, in coordination with the Secretary of Agriculture, should take steps to consult with respective sector partner(s), such as the SCC, DHS, and NIST, as appropriate, to collect and report sector-wide improvements from use of the framework across its critical infrastructure sector using existing initiatives. (Recommendation 7)

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

Comments: In written comments provided in January 2020, the Department of Health and Human Services (HHS) stated that it concurred with our recommendation. The department noted that it would work with the appropriate entities to refine and communicate best practices to the sector.

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 Secretary of Health and Human Services, jointly with the Secretary of Homeland Security, should collaborate to address information sharing gaps identified in this report to ensure that ORR receives information needed to make decisions for UAC, including those apprehended with an adult. (Recommendation 9)

Agency: Department of Health and Human Services
Status: Open

Comments: In commenting on a draft of our report, HHS reported that the department plans to coordinate with DHS, beginning in June 2020, on periodic updates to the interagency Joint Concept of Operations. To fully address this recommendation, HHS and DHS should address the information sharing gaps identified in our report.

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 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 Secretary of HHS should direct the Director of CDC to update the security plan for the selected system to identify the authorization boundary, the system operational environment and connections, a description of security controls, and the individual reviewing and approving the plan and date of approval. (Recommendation 8)

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

Comments: In June 2020, CDC stated it has taken actions to address our recommendations, but we have not received evidence of its corrective actions. We will continue to monitor the agency's progress and update the recommendation's status when CDC provides its corrective actions.

Recommendation: The Secretary of HHS should direct the Director of CDC to update the security assessment report for the selected system to identify the summarized results of control effectiveness tests. (Recommendation 9)

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

Comments: In June 2020, CDC stated it has taken actions to address our recommendations, but we have not received evidence of its corrective actions. We will continue to monitor the agency's progress and update the recommendation's status when CDC provides its corrective actions.

Recommendation: The Secretary of HHS should direct the Director of CDC to update the list of corrective actions for the selected system to identify the specific weaknesses, funding source, changes to milestones and completion dates, identified source of weaknesses, and status of corrective actions. (Recommendation 10)

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

Comments: In June 2020, CDC stated it has taken actions to address our recommendations, but we have not received evidence of its corrective actions. We will continue to monitor the agency's progress and update the recommendation's status once CDC provides its corrective actions.

Recommendation: The Secretary of HHS should direct the Administrator of CMS to update the system security plans for selected systems to identify a description of security controls. (Recommendation 11)

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

Comments: In June 2020, HHS stated CMS took actions to close this recommendation, but CMS has not yet provided evidence of its corrective actions. We will continue to monitor the agency's progress and update the recommendation's status when CMS provides its corrective actions.

Recommendation: The Secretary of HHS should direct the Administrator of CMS to update the security assessment report for selected system to identify the summarized results of control effectiveness tests. (Recommendation 12)

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

Comments: In June 2020, HHS stated CMS took actions to close this recommendation, but CMS has not yet provided evidence of its corrective actions. We will continue to monitor the agency's progress and update the recommendation's status when CMS provides its corrective actions.

Recommendation: The Secretary of HHS should direct the Administrator of CMS to update and document the CMS remedial action plan for the selected system to identify the anticipated source of funding. (Recommendation 13)

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

Comments: In June 2020, HHS stated CMS took actions to close this recommendation, but CMS has not yet provided evidence of its corrective actions. We will continue to monitor the agency's progress and update the recommendation's status when CMS provides its corrective actions.

Recommendation: The Secretary of HHS should direct the Administrator of CMS to prepare letters authorizing the use of cloud services for the selected systems and submit the letters to the FedRAMP program management office. (Recommendation 14)

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

Comments: In June 2020, HHS stated CMS took actions to close this recommendation, but CMS has not yet provided evidence of its corrective actions. We will continue to monitor the agency's progress and update the recommendation's status when CMS provides its corrective actions.

Recommendation: The Secretary of HHS should direct the Director of NIH to update security plans for selected systems to identify the authorization boundary, system operation in terms of mission and business processes, operational environment and connections, and a description of security controls. (Recommendation 15)

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

Comments: In June 2020, NIH stated it is taking actions to address this recommendation, but the agency did not provide evidence of its corrective actions. NIH stated it will provide an update in December 2020. We will continue to monitor the agency's progress and update the recommendation's status when NIH provides its corrective actions.

Recommendation: The Secretary of HHS should direct the Director of NIH to update the security assessment report for selected systems to identify summarized results of control effectiveness tests. (Recommendation 16)

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

Comments: In June 2020, NIH stated it is taking actions to address this recommendation, but the agency did not provide evidence of its corrective actions. NIH stated it will provide an update in December 2020. We will continue to monitor the agency's progress and update the recommendation's status when NIH provides its corrective actions.

Recommendation: The Secretary of HHS should direct the Director of NIH to update the NIH list of corrective actions for selected systems to identify estimated funding and anticipated source of funding, key milestones with completion dates, and changes to milestones and completion dates. (Recommendation 17)

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

Comments: In June 2020, NIH stated it is taking actions to address this recommendation, but the agency did not provide evidence of its corrective actions. NIH stated it will provide an update in December 2020. We will continue to monitor the agency's progress and update the recommendation's status when NIH provides its corrective actions.

Recommendation: The Secretary of HHS should direct the Director of NIH to submit the division's letters authorizing the use of cloud services for the selected systems to the FedRAMP program management office. (Recommendation 18)

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

Comments: In June 2020, NIH stated it is taking actions to address this recommendation, but the agency did not provide evidence of its corrective actions. NIH stated it will provide an update in December 2020. We will continue to monitor the agency's progress and update the recommendation's status when NIH provides its corrective actions.

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 the Agency for Healthcare Research and Quality should take steps to ensure appropriate agency-funded research data are readily findable and accessible to the public. (Recommendation 3)

Agency: Department of Health and Human Services: Public Health Service: Agency for Healthcare Research and Quality
Status: Open

Comments: The Agency for Healthcare Research and Quality 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 Commissioner of the Food and Drug Administration should take steps to ensure appropriate agency-funded research data are readily findable and accessible to the public. (Recommendation 4)

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

Comments: The Food and Drug Administration 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 the Agency for Healthcare Research and Quality should complete development of data management plan requirements. (Recommendation 9)

Agency: Department of Health and Human Services: Public Health Service: Agency for Healthcare Research and Quality
Status: Open

Comments: The Agency for Healthcare Research and Quality concurred with this recommendation. When we confirm what actions the agency has taken to implement the recommendation we will provide updated information.

Recommendation: The Commissioner of the Food and Drug Administration should evaluate training needs for agency officials or others involved in reviewing the merits of researchers' data management plans and, if additional training is found to be warranted, develop and provide such training. (Recommendation 14)

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

Comments: The Food and Drug Administration concurred with this recommendation. When we confirm what actions the agency has taken to implement the recommendation we will provide updated information.

Recommendation: The Director of the Agency for Healthcare Research and Quality should evaluate training needs for agency officials or others involved in reviewing the merits of researchers' data management plans and, if additional training is found to be warranted, develop and provide such training. (Recommendation 17)

Agency: Department of Health and Human Services: Public Health Service: Agency for Healthcare Research and Quality
Status: Open

Comments: The Agency for Healthcare Research and Quality concurred with this recommendation stating that it would assess training needs for agency officials and others involved in reviewing the merits of researchers' data management plans and would develop and provide additional training if warranted. When we confirm what actions the agency has taken to implement the recommendation we will provide updated information.

Recommendation: The Director of the Agency for Healthcare Research and Quality should develop and implement a mechanism to ensure researcher compliance with the public access plan and associated requirements.(Recommendation 23)

Agency: Department of Health and Human Services: Public Health Service: Agency for Healthcare Research and Quality
Status: Open

Comments: The Agency for Healthcare Research and Quality 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 Commissioner of the Food and Drug Administration should develop and implement a mechanism to ensure researcher compliance with the public access plan and associated requirements. (Recommendation 24)

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

Comments: The Food and Drug Administration 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 the National Institutes of Health should fully develop and implement a mechanism to ensure researcher compliance with the public access plan and associated requirements. (Recommendation 25)

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

Comments: The National Institutes of Health concurred with this recommendation but stated that the agency already had mechanisms in place to ensure compliance with public access plan and associated requirements for publications and data. As discussed in the report, we believe our recommendation, as worded, appropriately reflected the extent to which the agency had implemented researcher compliance mechanisms at the time of issuance of our report. When we confirm what actions the agency has taken in response to the recommendation, we will provide updated information.

Recommendation: As the Subcommittee on Open Science moves forward, the National Institutes of Health co-chair, in coordination with other co-chairs and participating agencies, should take steps to fully implement leading practices that enhance and sustain collaboration. (Recommendation 35)

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

Comments: NIH concurred with GAO's November 2019 recommendation. NIH stated that the subcommittee and its working groups are actively coordinating and building consensus on issues and processes to implement leading practices that enhance and sustain collaboration across federal agencies. In March 2020, the Office of Science and Technology Policy provided information on steps the subcommittee has taken to address issues associated with public access to federally funded research results, including certain areas GAO identified as presenting challenges to public access plan implementation in the November 2019 report. GAO will collect and evaluate additional information to determine the extent to which these steps incorporate leading practices for interagency collaboration GAO has identified. By taking steps to fully implement the relevant leading practices we have identified, the subcommittee and its member agencies could better marshal their collective efforts to address common public access plan implementation challenges that agency officials and stakeholders identified.

Recommendation: The Administrator of ACL should work with other relevant HHS officials to document the department's plan to focus on the specific nutritional needs of older adults in the 2025-2030 update of the Dietary Guidelines for Americans, which would include, in part, plans to identify existing information gaps on older adults' specific nutritional needs. (Recommendation 1)

Agency: Department of Health and Human Services: Administration for Community Living
Status: Open

Comments: HHS agreed with this recommendation, stating that ACL plans to work with the Office of Disease Prevention and Health Promotion and other relevant HHS officials and agencies to document HHS's plans to emphasize the specific and varying nutritional needs of older adults in the 2025-2030 update. HHS also stated that ACL plans to acquire the services of a registered dietician with specialized expertise in older adults' nutritional needs. We will consider closing this recommendation when these efforts are completed.

Recommendation: The Administrator of ACL should direct regional offices to take steps to ensure states are monitoring providers to ensure meal consistency with federal nutrition requirements for meals served in the congregate and home-delivered meal programs. (Recommendation 2)

Agency: Department of Health and Human Services: Administration for Community Living
Status: Open

Comments: HHS agreed with this recommendation. HHS stated that ACL's program and evaluation offices will collaborate on the development of plans to ensure state compliance with federal requirements.

Recommendation: The Administrator of ACL should centralize information on promising approaches for making meal accommodations to meet the nutritional needs of older adult participants in the congregate and home-delivered meal programs, for example in one location on its National Resource Center on Nutrition and Aging website, to assist providers' efforts. (Recommendation 4)

Agency: Department of Health and Human Services: Administration for Community Living
Status: Open

Comments: HHS agreed with this recommendation. The agency stated that ACL will award a contract in fiscal year 2020 for a new National Resource Center on Nutrition and Aging to, among other things, centralize information on promising approaches so nutrition services providers can access it easily. We will consider closing this recommendation when this effort is complete.

Recommendation: The Director of OCS, in developing the new performance management approach for the CSBG program, should ensure that its performance framework includes information on (1) details for how the national measure is linked to and used to assess the three national program goals, (2) descriptions of how the updated state and local performance outcome measures align with national program goals, and (3) a written plan for how OCS will assess the reliability of state performance outcome data. (Recommendation 1)

Agency: Department of Health and Human Services: Office of Community Services
Status: Open

Comments: HHS agreed with this recommendation and and stated that it plans to take actions to better align its performance measures with the three national performance goals outlined in the new CSBG Theory of Change. We commend HHS for its plans to address this recommendation, but encourage the agency to focus on aligning its performance outcomes with the three national goals of the CSBG program as established by the CBBG Act, which are similar but not identical to the three goals outlined in the new CSBG Theory of Change. HHS also stated that it would implement additional actions to assess the reliability of state performance outcome data.

Recommendation: The Commissioner of FDA should establish a process to monitor whether the agency is meeting its audit goals and expectations for sampling and inspections to support its removal decisions for seafood import alerts. This could be done through regularly analyzing data that FDA collects, such as those in CMS, FACTS, and OASIS. (Recommendation 1)

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

Comments: FDA agreed with our recommendation. In August 2020, FDA told us that the agency is working to review and modify appropriate sections of its Regulatory Procedures Manual to better reflect the importance of foreign suppliers' corrective actions when making decisions to remove a firm from an import alert and identify higher-risk problem areas where more robust information may be needed. In addition, a checklist for import alerts and associated Compliance Management System (database) functionality are under development. According to FDA, the agency is also working to refine internal communications to better assure that firms which have recently been removed from an import alert are also considered for an inspection. Additionally, in November 2019, FDA published a Notice of Proposed Rulemaking on accreditation of laboratories that conduct food testing to support removal from import alert and other purposes. We will continue to monitor FDA's planned actions to determine if they satisfy our recommendation.

Recommendation: The Commissioner of FDA should establish a time frame for developing performance goals and measures for its imported food safety program. (Recommendation 2)

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

Comments: FDA agreed with this recommendation. In August 2020, FDA told us that the agency has published some performance metrics and plans to develop additional performance measures and outcome indicators for imported food safety, to support FDA's Strategy for the Safety of Imported Food (Strategy). In addition, after publishing these initial metrics for the Strategy, the agency will develop additional performance metrics. FDA stated that the COVID-19 situation is quite fluid and the agency is unable to project timelines for developing additional performance measures at this time. We will continue to monitor FDA's planned actions to determine if they satisfy our recommendation.

Recommendation: The Commissioner of FDA should, as the agency develops goals and measures for its imported food safety program, develop performance goals and corresponding performance measures specific to seafood import alerts. (Recommendation 3)

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

Comments: FDA agreed with this recommendation. In August 2020, FDA told us that the agency remains committed to developing additional performance goals and measures for its imported food safety program. FDA is still reviewing the Import Alert Effectiveness Program and will consider metrics, as appropriate, based on the outcome of that review. FDA stated that the COVID-19 situation is quite fluid and the agency is unable to project timelines for developing additional performance measures at this time. We will continue to monitor FDA's planned actions to determine if they satisfy our recommendation.

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: 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 Health and Human Services should issue a progress report on the department's environmental justice efforts each year. (Recommendation 14)

Agency: Department of Health and Human Services
Status: Open

Comments: In comments on our report, the department agreed with this recommendation. We will continue to review the department's actions and provide updated information.

Recommendation: The Director of OHS should perform a fraud risk assessment for the Head Start program, to include assessing the likelihood and impact of fraud risks it faces. (Recommendation 1)

Agency: Department of Health and Human Services: Administration for Children and Families: Office of Head Start
Status: Open
Priority recommendation

Comments: In February 2020, HHS told us that the Administration for Children and Families (ACF) is developing a Fraud Risk Assessment template for all of its programs (including the Office of Head Start) and is on track to complete the initial Fraud Risk Assessment for its pilot program by June 30, 2020. Upon completion of the Fraud Risk Assessment for the ACF pilot program, ACF anticipates completing its initial Fraud Risk Assessment for OHS, by March 31, 2021. We will assess these actions once completed.

Recommendation: The Director of OHS should establish procedures to monitor and evaluate OHS's new internal workflows for monitoring reviews, to include establishing a baseline to measure the effect of these workflows and identify and address any problems impeding the effective implementation of new workflows to ensure timeliness goals for monitoring reviews are met. (Recommendation 3)

Agency: Department of Health and Human Services: Administration for Children and Families: Office of Head Start
Status: Open

Comments: HHS did not concur with this recommendation. In February 2020, HHS stated that OHS regularly evaluates its effectiveness of its workflows to determine how to best adjust the system to support effective follow-up. HHS also stated that, for Fiscal Year 2020, OHS has updated its internal workflow timelines to increase responsiveness to identified findings and ensure grantee support. We will continue to monitor HHS's efforts in this area.

Recommendation: The Director of OHS should provide program-wide guidance on when a student's slot should be considered vacant due to absenteeism. (Recommendation 5)

Agency: Department of Health and Human Services: Administration for Children and Families: Office of Head Start
Status: Open

Comments: In February 2020, OHS told us that it is finalizing program guidance that will address when a child's slot should be considered vacant due to absenteeism and what a program should do fill it. OHS stated that it anticipates having a final paper published by summer, 2020. We will continue to monitor OHS's efforts in this area.

Recommendation: The Director of OHS should develop and implement a method for grantees to document attendance and services under EHS pregnancy programs. (Recommendation 6)

Agency: Department of Health and Human Services: Administration for Children and Families: Office of Head Start
Status: Open

Comments: In February 2020, OHS told us that it is developing a toolkit of resources specifically designed to offer best practice tips for Early Head Start programs on how to track attendance and services to pregnant women. OHS is surveying the Head Start community to better determine what resources are already available and how programs in different regions and cities track services to pregnant women. OHS anticipates a rollout for the toolkit by summer, 2020.

Recommendation: The Commissioner of FDA should work with the Secretary of Agriculture to develop a mechanism to facilitate coordination with relevant nonfederal stakeholders, including state, local, and tribal governments, on actions related to date labels as part of their efforts to reduce food loss and waste. (Recommendation 2)

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

Comments: FDA agreed with our recommendation and is taking actions to implement the recommendation. For example, as of August 2020, FDA said it is meeting regularly with USDA and EPA to coordinate activities including to clarify and communicate information on food date labels. FDA also named a representative to the Association of Food and Drug Officials (AFDO) Food Recovery Committee. FDA is encouraging the Committee to explore how date labels on packaged foods can create a barrier to food donation and to track state legislative activities related to date labeling of food. We will update the status of this recommendation as FDA makes more progress.

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 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 Health and Human Services should develop a cybersecurity risk management strategy that includes the key elements identified in this report. (Recommendation 10)

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

Comments: The Department of Health and Human Services concurred with this recommendation. As of January 2020, HHS stated that it is drafting a cybersecurity risk management memo that will detail its risk management strategy, including how the department will assess, respond to, and monitor risk. Once the department has provided evidence of these actions, we plan to verify whether implementation has occurred.

Recommendation: The Secretary of Health and Human Services should update the department's policies to require (1) an organization-wide cybersecurity risk assessment and (2) the use of risk assessments to inform security control tailoring. (Recommendation 11)

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services partially concurred with this recommendation. As of January 2020, HHS stated that it is in the process of updating its policies to address the missing elements and plans to finalize the revisions by March 2021. Once the department has provided evidence of these actions, we plan to verify whether implementation has occurred.

Recommendation: The Secretary of Health and Human Services should establish a process for conducting an organization-wide cybersecurity risk assessment. (Recommendation 12)

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

Comments: The Department of Health and Human Services concurred with this recommendation. As of January 2020, HHS stated that it is drafting a cybersecurity risk management memo and capability model that will include a process for an organization-wide assessment of cybersecurity risk. Once the department has provided evidence of these actions, we plan to verify whether implementation has occurred.

Recommendation: The Administrator of Centers for Medicare & Medicaid Services (CMS) should create and implement a policy for standard posting requirements regarding comments and their identity information, particularly for duplicate comments, and should clearly communicate this policy to the public on the CMS website. (Recommendation 2)

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

Comments: In January 2020, the Department of Health and Human Services stated that CMS already has policies for standard posting requirements, and noted that they would update their policy and communicate it on the CMS website. However, while CMS provided us with an excerpt of the updated language, as written, it does not include information about how the agency posts duplicate comments. Further, CMS did not provide us with this policy, and our review of the website does not indicate any changes have been made. HHS stated it would provide additional follow up actions by 7/23/2020. Given that we found significant variation in the way that CMS posts comments, even within a single docket, we continue to believe that it is important for CMS to develop and implement a standard policy for posting duplicate comments and their identity information, in addition to communicating this policy to the public on the CMS website.

Recommendation: The Commissioner of FDA should work with the Administrator of EPA and Secretary of Agriculture to incorporate leading collaboration practices as they implement their interagency FLW reduction strategic plan, to include (1) agreeing on roles and responsibilities; (2) developing mechanisms to monitor, evaluate, and report on results; (3)clearly defining short- and long-term outcomes; (4) identifying how leadership commitment will be sustained; and (5) ensuring that the relevant stakeholders have been included in the collaborative effort. (Recommendation 2)

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

Comments: The agency agreed with this recommendation. As of December 2019, we are following up with the agency. 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 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 Administrator of ACL should take steps to better centralize access to and promote awareness of information on promising practices or other useful information pertinent to serving rural older adults.

Agency: Department of Health and Human Services: Administration for Community Living
Status: Open

Comments: HHS agreed with this recommendation, stating that it would encourage its resource centers to identify promising practices and other information specific to rural communities so that these resources would be searchable. In December 2019, ACL stated that it would continue to list all resource centers on its website so that anyone can find resources specific to any topic funded by ACL. The agency also noted that it would begin implementation of this action with new resource centers funded with FY 2020 appropriations. GAO continues to encourage ACL to centralize access to information pertinent to rural older adults by making it easily searchable across these websites or compiling it in other ways and promoting awareness of this information.

Recommendation: The Administrator of the Centers for Medicare and Medicaid Services should develop a plan with time frames and milestones to discontinue knowledge-based verification, such as by using Login.gov or other alternative verification techniques. (Recommendation 1)

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

Comments: HHS, on behalf of CMS, did not concur with this recommendation. In its February 2020 response to GAO, HHS stated that current NIST guidance to agencies was insufficient and that CMS would look forward to future guidance from NIST and OMB to help guide consideration of non-knowledge-based verification options. We continue to believe that our recommendation is valid because a variety of alternative methods to knowledge-based verification are available that CMS can consider to address the diverse population it serves. Further, NIST has agreed with our recommendation to develop additional guidance for agencies, and CMS may be able to use that guidance to identify a verification approach that does not really on knowledge-based techniques. We will continue to monitor the actions CMS may take to address the recommendation.

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 Senior Procurement Executive for the Department of Health and Human Services (HHS) should review the contracts we identified as being awarded to contractors that reported qualifying federal tax debt under FAR § 52.209-11 and (1) determine whether the contracting officer was required to consider the contractor's reported tax debt; if so, (2) determine the reasons controls to identify and refer these contractors to the SDO before contract award did not operate effectively; and (3) design or modify controls to help ensure compliance with applicable regulations. (Recommendation 2)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS provided us information on their review of the contracts that reported qualifying federal tax debt under FAR ? 52.209-11. We are assessing HHS's review of these contracts and will provide updated information when we confirm whether the agency's review, and any subsequent actions stemming from its review, are consistent with our recommendation.

Recommendation: The Senior Procurement Executive for HHS should review the contracts we identified as being awarded to contractors that reported qualifying federal tax debt under FAR § 52.209-5. Specifically, the Senior Procurement Executive should determine whether each contract value was expected to exceed the simplified acquisition threshold when the solicitation was issued and, if so, (1) determine the reasons controls to identify and notify the SDO of these contractors before contract award did not operate effectively and (2) design or modify controls to help ensure compliance with applicable regulations. (Recommendation 7)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS provided us information on their review of the contracts that reported qualifying federal tax debt under FAR ? 52.209-5. We are assessing HHS's review of these contracts and will provide updated information when we confirm whether the agency's review, and any subsequent actions stemming from its review, are consistent with our recommendation.

Recommendation: The Secretary of the Department of Health and Human Services (HHS) should take action to meet the data center closure targets established under DCOI by OMB. (Recommendation 8)

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services (HHS) is taking action to implement our recommendation. After the Office of Management and Budget (OMB) released the updated Data Center Optimization Initiative policy in June 2019, the department established a new data center closure target. The department subsequently reported meeting its closure target for fiscal year 2019. However, given the short time to evaluate implementation efforts between when OMB released the updated policy in June 2019 and the end of fiscal year 2019, we will continue to monitor HHS's efforts to implement this recommendation through fiscal year 2020.

Recommendation: The Secretary of HHS should take action to meet the data center optimization metric targets established under DCOI by OMB. (Recommendation 9)

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services (HHS) is taking action to implement our recommendation. After the Office of Management and Budget (OMB) released the updated Data Center Optimization Initiative policy in June 2019, the department established new data center optimization targets. Subsequently, the department reported meeting its targets for the virtualization, advanced energy metering, and server utilization metrics. However, given the short time to evaluate implementation efforts between when OMB released the updated policy in June 2019 and the end of fiscal year 2019, we will continue to monitor HHS's efforts to implement this recommendation through fiscal year 2020.

Recommendation: The Secretary of the Department of Health and Human Services (HHS) should ensure that the CIO of HHS establishes guidance on assessing new and existing IT investments for suitability for cloud computing services, in accordance with OMB guidance. (Recommendation 13)

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services (HHS) concurred with our recommendation and stated that the Office of the CIO would revise its guidance by September 30, 2019 to address it. As of May 2020, we have not received a more recent update from HHS regarding its implementation of our recommendation. We will continue to monitor HHS's progress in implementing this recommendation.

Recommendation: The Secretary of Health and Human Services should ensure that the CIO of HHS completes an assessment of all IT investments for suitability for migration to a cloud computing service, in accordance with OMB guidance. (Recommendation 14)

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services (HHS) concurred with our recommendation and stated that the CIO would complete an assessment of all IT investments as part of its portfolio review for fiscal year 2021. As of May 2020, we have not received a more recent update from HHS regarding its implementation of our recommendation. We will continue to monitor HHS's progress in implementing this recommendation.

Recommendation: The Secretary of Health and Human Services should ensure that the CIO of HHS establishes a consistent and repeatable mechanism to track savings and cost avoidances from the migration and deployment of cloud services. (Recommendation 15)

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services (HHS) concurred with our recommendation and stated that the CIO would take action to track savings as part of its portfolio review process for fiscal year 2021. As of May 2020, we have not received a more recent update from HHS regarding its implementation of our recommendation. We will continue to monitor HHS's progress in implementing this recommendation.

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 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: To complete the appropriate assignment of codes to their positions performing IT, cybersecurity, or cyber-related functions, in accordance with the requirements of the Federal Cybersecurity Workforce Assessment Act of 2015, the Secretary of Health and Human Services should take steps to review the assignment of the "000" code to any positions in the department in the 2210 IT management occupational series and assign the appropriate NICE framework work role codes. (Recommendation 8)

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

Comments: The Department of Health and Human Services concurred with the recommendation and stated that it would complete a review of the assignment of the "000" code to its positions in the 2210 IT management occupational series and assign the appropriate NICE framework work role codes. As of March 2020, HHS has made significant progress toward reviewing the assignment of work role codes to its positions in the 2210 IT management occupational series and ensuring that such positions are not coded with the "000" code. To fully implement this recommendation, HHS will need to provide evidence that it has assigned the appropriate NICE framework work role codes to all or nearly all of its remaining positions in the 2210 IT management occupational series. We will continue to monitor the situation.

Recommendation: The Secretary of Health and Human Services should revise HHS's process for conducting improper payment risk assessments for Head Start to help ensure that it results in a reliable assessment of whether the program is susceptible to significant improper payments. This should include preparing sufficient documentation to support its risk assessments. (Recommendation 1)

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

Comments: The Department of Health and Human Services (HHS) concurred with this recommendation. In fiscal year 2019, HHS reported that it utilized Microsoft SharePoint to facilitate and begin to automate the Improper Payment Risk Assessment process. According to HHS, the SharePoint risk assessment form included the added ability to track the status of submissions and collect any applicable supporting documentation. Also, HHS stated that the Assistant Secretary for Financial Resources staff discussed the importance of maintaining supporting documentation during the fiscal year 2019 Improper Payment Risk Assessment Kick-Off meeting with HHS's operating divisions, and also built this feature into the SharePoint form. In fiscal year 2020, HHS reported that the implementation of the long-term solution to conducting improper payment risk assessments, the Risk Assessment Portal (previously called the Automated Improper Payment Framework), is underway and went into production in March 2020. Additionally, HHS indicated that it has revised its improper payment questionnaire and scoring process to ensure HHS performs a reliable assessment of susceptibility to significant improper payments. Also, HHS stated that it will leverage the Risk Assessment Portal, new questionnaire, and revised scoring process in the fiscal year 2020 risk assessment reporting period. Further, HHS stated that it is reviewing GAO reports and resources, capturing best practices from other agencies, and soliciting feedback from HHS's operating divisions to further improve its processes. Last, HHS stated that it will continue to develop policies, procedures, and supporting tools throughout calendar year 2020. We will continue to monitor the agency's actions to address this recommendation.

Recommendation: The Secretary of Health and Human Services should revise HHS's procedures for conducting improper payment risk assessments to help ensure that all programs and activities are assessed for susceptibility to significant improper payments at least once every 3 years, as required by IPIA. (Recommendation 2)

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

Comments: The Department of Health and Human Services (HHS) concurred with this recommendation. In fiscal year 2019, HHS reported that it utilized DATA Act information to create an inventory of programs and activities that could potentially be subject to improper payment risk assessment requirements. According to HHS, it developed a risk-based methodology for selecting programs and activities for review using the DATA Act files. Data fields within the DATA Act files allow HHS to further analyze the program and activity inventory. For example, the object class data enabled HHS to categorize the program's spending to provide insight into each program's unique risks. HHS stated that this methodology was used and documented in fiscal year 2019 but HHS plans to further refine and finalize this approach. In fiscal year 2020, HHS reported that its Office of the Inspector General (OIG) is currently reviewing the methodology as part of the Annual Inspector General review of HHS's improper payment reporting under the Improper Payments Elimination and Recovery Act of 2020. HHS stated that it will implement any feedback from the OIG, as well as lessons learned from the fiscal year 2019 and fiscal year 2020 risk assessment reporting period, in fiscal year 2021. We will continue to monitor the agency's actions to address 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 Secretary of Health and Human Services should provide guidance, training, or other instruction to help contracting officials: (1) Identify the factors that should be considered in order to determine the applicability of the Trade Agreements Act and waiver of the Buy American Act; (2) Document determinations of the use of Buy American exceptions for domestic non-availability and ensure the required approvals are obtained; and (3) Identify sources of information available for determining products' origins and the steps they should take to verify information that is inconsistent. (Recommendation 4)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS concurred with this recommendation and has taken steps to implement it. HHS issued a memorandum in February 2019 requiring all contracting officers as part of their continuous learning program to complete the Buy American Statute course, FAC063, offered by the Federal Acquisition Institute. As of February 2020, about 90 percent of contracting officials had taken the required training. However, due to its COVID-19 Pandemic response activities, HHS stated that all of its contracting officials had not completed the training as intended. HHS also developed checklists and guidance related to the Buy American Act and Trade Agreements Act. We plan to keep this recommendation open until HHS completes its training initiative.

Recommendation: The Secretary of Health and Human Services should direct the Associate Deputy Assistant Secretary for Acquisition to identify the reasons behind the high rate of miscoding for orders awarded under multiple award contracts and use this information to identify and take action to improve the reliability of the competition data entered into FPDS-NG. (Recommendation 2)

Agency: Department of Health and Human Services
Status: Open

Comments: In February 2019, HHS stated it was performing analysis and research to understand the reasons for the miscoding of orders. Once this analysis and research is completed, HHS reported it plans to work to address the root causes of the previously identified miscodings, so as to prevent future errors. In July 2019, HHS officials stated they did not have an update regarding planned actions to address the recommendation. As of September 2020, HHS officials did not respond to our multiple requests for updates to this recommendation.

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 Health and Human Services should ensure that the Office of the CIO and other offices, as appropriate, address gaps in the department's FITARA plans by developing and implementing policies and procedures that establish department-wide policy for the level of detail of planned expenditure reporting to the CIO for all transactions that include IT resources. (Recommendation 16)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS agreed with this recommendation and is planning to take steps to implement it. Specifically, the agency intends to update its IT investment planning policy to include requirements for reporting expenditures that apply to all transactions with an IT component. We will continue to monitor the department's progress towards implementing our recommendation.

Recommendation: The Secretary of Health and Human Services should ensure that the Office of the CIO and other offices, as appropriate, address gaps in the department's FITARA plans by developing and implementing policies and procedures that include the CIO in the planning and budgeting stages for all programs that are fully or partially supported with IT resources. (Recommendation 17)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS agreed with the recommendation and is planning to take steps to implement it. Specifically, the agency intends to update its IT investment planning policy to amplify the CIO's role in the planning and budgeting stages for all programs with IT resources. Also, HHS intends to document procedures for ensuring that all delegated authorities are carried out. We will continue to monitor the department's progress towards implementing our recommendation.

Recommendation: The Secretary of Health and Human Services should ensure that the Office of the CIO and other offices, as appropriate, address gaps in the department's FITARA plans by developing and implementing policies and procedures that include the CIO as a member of governance boards that inform decisions regarding all IT resources, including component-level boards. (Recommendation 18)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS agreed with the recommendation. The department has provided charters that included the CIO as a member of department-level governance boards that inform IT decisions. However, HHS has not provided charters that include the CIO as a member of component-level IT governance boards. We will continue to monitor the department's progress in implementing our recommendation.

Recommendation: The Secretary of Health and Human Services should ensure that the Office of the CIO and other offices, as appropriate, address gaps in the department's FITARA plans by developing and implementing policies and procedures that document the processes by which program leadership works with the CIO to plan an overall portfolio of IT resources. (Recommendation 19)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS agreed with the recommendation and is planning to take steps to implement it. For example, HHS plans to develop an asset management policy and introduce a pilot program to manage inventories across the agency. However, the department has not developed policies and procedures that incorporate the processes by which the program leadership are planning the IT portfolio with the CIO for existing investments greater than or equal to $20 million annually and for investments delegated to components. We will continue to monitor the department's progress in implementing our recommendation.

Recommendation: The Secretary of Health and Human Services should ensure that the Office of the CIO and other offices, as appropriate, address gaps in the department's FITARA plans by developing and implementing policies and procedures that document the process for the CIO's review and approval of the major IT investments portion of the budget request. (Recommendation 20)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS agreed with the recommendation and is planning to take steps to implement it. Specifically, the department intends to update its IT investment planning policy to amplify the CIO's role in reviewing major investments. We will continue to monitor the department's progress in implementing our recommendation.

Recommendation: The Secretary of Health and Human Services should ensure that the Office of the CIO and other offices, as appropriate, address gaps in the department's FITARA plans by developing and implementing policies and procedures that document the CIO's role in reviewing IT resources that are to support major program objectives and significant increases and decreases in IT resources. (Recommendation 21)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS agreed with this recommendation and has taken steps towards implementing it. Specifically, HHS documented procedures that require the CIO to hold annual IT investment review meetings with components to review changes in IT resources. However, HHS has not documented procedures for the CIO's role in reviewing major program objectives. We will continue to monitor the department's progress toward implementing our recommendation.

Recommendation: The Secretary of Health and Human Services should ensure that the Office of the CIO and other offices, as appropriate, address gaps in the department's FITARA plans by developing and implementing policies and procedures that document the steps the CIO is to take to ensure whether the IT portfolio includes appropriate estimates of all IT resources included in the budget request. (Recommendation 22)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS agreed with the recommendation and is planning to take steps to implement it. Specifically, the department intends to assess and update its existing policies and procedures to document the steps the CIO is to take to review the IT portfolio for appropriate estimates of all IT resources. We will continue to monitor the department's progress toward implementing our recommendation.

Recommendation: The Secretary of Health and Human Services should direct the department CIO to establish, for any OMB common baseline requirements that are related to IT budgeting that have been delegated, a plan that specifies the requirement being delegated, demonstrates how the CIO intends to retain accountability for the requirement, and ensures through quality assurance processes that the delegated official will execute such responsibilities with the appropriate level of rigor. (Recommendation 23)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS agreed with the recommendation and is planning to take steps to implement it. Specifically, the department intends to develop an IT governance policy to define the accountability of the CIO over all IT projects and establish processes detailing quality reviews and the level of rigor that should be applied by its IT governance board. We will continue to monitor the department's progress towards implementing our recommendation.

Recommendation: The Secretary of Health and Human Services should direct the Office of the CIO and other offices, as appropriate, to take steps to ensure that the actions taken to comply with OMB's common baseline for implementing FITARA on individual investments are adequately documented. (Recommendation 24)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS agreed with the recommendation and is planning to take steps to implement it. Specifically, the agency intends to update its IT acquisition program policy and related processes. HHS also plans to document standard operating procedures for agency wide dissemination to ensure the effectiveness and efficiency of IT investment governance through transparent and repeatable procedures. We will continue to monitor the agency's progress in implementing our recommendation.

Recommendation: The Secretary of Health and Human Services should ensure that the Office of the CIO and other offices, as appropriate, establish quality assurance processes--such as data quality checks, reviews of estimation methods, linkages between the IT portfolio and procurement system data, and linkages between the IT portfolio and financial system data--for ensuring the annual IT budget is informed by complete and reliable information on anticipated government labor, contract, and other relevant IT expenditures. (Recommendation 25)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS agreed with the recommendation and are planning to take steps towards implementing it. Specifically, HHS established a working group and developed a roadmap for implementing the Technology Business Management Framework by fiscal year 2022. The agency anticipates that its strategy and approach will enable HHS to, among other things, link IT portfolio data, procurement system data, and financial system data. We will continue to monitor the department's progress towards implementing our recommendation.

Recommendation: The Administrator of CMS should ensure that the Office of the CIO and other offices, as appropriate, develop and implement policies and procedures that include the CIO in the planning and budgeting stages for all programs that are fully or partially supported with IT resources. (Recommendation 26)

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

Comments: CMS agreed with our recommendation. 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 the Office of the CIO and other offices, as appropriate, develop and implement policies and procedures that document the processes by which program leadership works with the CIO to plan an overall portfolio of IT resources. (Recommendation 27)

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

Comments: CMS agreed with our recommendation. 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 the Office of the CIO and other offices, as appropriate, develop and implement policies and procedures that document the CIO's role in reviewing IT resources that are to support major program objectives and significant increases and decreases in IT resources. (Recommendation 28)

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

Comments: CMS agreed with our recommendation. 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 direct the Office of the CIO and other offices, as appropriate, to take steps to ensure that the actions taken to comply with OMB's common baseline for implementing FITARA on individual investments are adequately documented. (Recommendation 29)

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

Comments: CMS agreed with our recommendation. 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 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 HHS should establish a process to monitor and evaluate HHS's grants training at the central office level. This process should include (1) a method for identifying all employees working on grants across the agency, and (2) oversight procedures to evaluate the sufficiency of sub-agencies' grants training efforts including the incorporation of leading practices related to assessing competencies, training approaches, accountability, and training results. (Recommendation 3)

Agency: Department of Health and Human Services
Status: Open

Comments: HHS concurred with our findings and recommendation. In its comment letter, HHS stated that its Office of Grants Policy, Oversight, and Evaluation, within the Office of Grants and Acquisition Policy and Accountability, Division of Grants, in conjunction with the HHS ReInvent Grants Initiative would be developing and implementing a department-wide financial assistance training and certification program to improve the functional effectiveness of the financial assistance management workforce in the areas of internal controls and risk mitigation. The program is designed to support the professional development of the HHS grants management workforce through both instructor-led and online courses. HHS' ReInvent Grants Management (RGM) staff and GAO held a conference call on November 30th, 2018 to discuss how RGM intended to address the recommendation in GAO-18-491 by developing a generalized framework for the Grants Management Training and Certification (GMTC) program for HHS. An HHS official reported that at its December 2019 quarterly meeting, the HHS Division of Workforce Development (DWD) reported they had in the past quarter: briefed the HHS Executive Committee on Grants Administration Policy (ECGAP) on the DWD mission and goals for training the grants workforce; developed briefing documents and presentations based on a RGM developed framework to develop competencies and outline curriculum of the GMTC program; continued to review and refine the program framework to incorporate DWD mission and goals; drafted the initial policy to further inform the structure and procedures of the GMTC program (e.g. certification levels, required coursework, career development requirements), which should be issued by HHS Office of Grants within Federal Fiscal Year 2020; and collaborated with the HHS Grants Closeout Business Process Reengineering Team to discuss current grants closeout status and how DWD can support grant staff and grant recipient closeout training efforts. Given the ongoing nature of HHS efforts, GAO will continue to monitor progress on a quarterly basis.

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 Secretary of Health and Human Services should ensure that the department's IT management policies address the role of the CIO for key responsibilities in the six areas we identified. (Recommendation 9)

Agency: Department of Health and Human Services
Status: Open

Comments: The agency agreed with the recommendation and revised its policies to address three of the 23 responsibility gaps identified in the report. In particular, it has addressed the responsibilities for the Chief Information Officer to: 1) report directly to the agency head or that official's deputy, 2) improve the management of the agency's IT through portfolio review (PortfolioStat), and 3) maintain an inventory of data centers. We will continue to monitor the steps the agency takes to address the remaining responsibilities.

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 Secretary of Health and Human Services should review the policies, procedures, and related control activities to ensure that the agency's Paperwork Reduction Act review process is operating effectively. (Recommendation 5)

Agency: Department of Health and Human Services
Status: Open

Comments: In October 2018, HHS provided a statement of actions it had taken to address this recommendation. HHS stated that it had added reporting tools to its Common Data Element Repository (CDER) Library that could help improve tracking of information related to HHS's Information Collection Requests. HHS also stated that it had launched daily emails to Paperwork Reduction Act (PRA) staff to inform them of Office of Management and Budget (OMB) Notices of Action related to Information Collection Requests. Additionally, HHS released an information collection burden calculator tool in the CDER Library to give PRA staff the ability to create burden tables for consistent use across multiple platforms for a single Information Collection Request. According to HHS officials, this tool incorporates both wages and employee benefits in the burden calculations. As of August 2019, HHS's burden calculator tool has been included as a resource on PRA.Digital.gov, a new OMB website that serves as a PRA knowledge base for federal staff. While these are important steps, we are awaiting additional details on how these changes have affected HHS's PRA review process. We will continue to monitor HHS's progress toward addressing our recommendation.

Recommendation: The Secretary of Health and Human Services should leverage existing consultation with stakeholders and the public to explicitly seek input on the estimated burden imposed by information collections. (Recommendation 6)

Agency: Department of Health and Human Services
Status: Open

Comments: In October 2018, HHS stated that it continues to leverage consultation mechanisms for input on the burdens imposed by information collections. According to the agency, it plans to increase the use of the eRulemaking program's Federal Docket Management System for all information collections, including non-rule Information Collection Requests. HHS also stated it plans to contact stakeholders to discuss potential information collections and receive burden estimates. As of August 9, 2019, we have not received an update about HHS's actions or plans. We will continue to monitor HHS's efforts to address our recommendation.

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 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 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 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 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 HHS should, consistent with its existing statutory authority, take additional steps to provide oversight of financial interchange calculations at the individual-case level. If the Secretary concludes that there are limitations in its authority in this area, the Secretary should seek to obtain the necessary additional authority. (Recommendation 8)

Agency: Department of Health and Human Services
Status: Open

Comments: As of July 2020, HHS continues to disagree with this recommendation. HHS officials said that RRB is responsible for certifying its costs through the financial interchange, and that they believe the department lacks the authority to question RRB's calculations. We continue to believe that HHS would be better positioned to ensure that the transfers it makes and receives through the interchange are calculated correctly if it reviews case-level calculations. We will close this recommendation if HHS seeks the authority to review financial interchange calculations or takes other steps to ensure the accuracy of financial interchange calculations performed by RRB.

Recommendation: The Commissioner of FDA should develop a timeline for updating the risk assessment on arsenic in rice. (Recommendation 1)

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

Comments: As of August 2020, FDA stated that it will update the risk assessment when more scientific evidence becomes available. In the meantime, FDA noted that it will continue to monitor research in this area, including ongoing work by the National Academies of Sciences (NAS) Board on Environmental Studies and Toxicology, which is currently reviewing EPA's work on inorganic arsenic, specifically on EPA's IRIS Toxicological Assessments of Inorganic Arsenic. GAO will assess whether FDA has taken action responsive to the recommendation when additional information becomes available.

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 Health and Human Services, in cooperation with the Secretary of Agriculture, should take steps to consult with respective sector partner(s), such as the SCC, DHS and NIST, as appropriate, to develop methods for determining the level and type of framework adoption by entities across their respective sector. (Recommendation 6)

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

Comments: In written comments, the Department of Health and Human Services (HHS) concurred with the recommendation in our report and stated that it would work with appropriate entities to assist in sector adoption. HHS officials, in collaboration with NIST and a joint Cybersecurity Working Group, developed 10 best practices in May 2017 (Health Industry Cybersecurity Practices) for the Healthcare and Public Health Services sector based on the framework. These practices allowed stakeholders to identify how to use the framework with existing sector resources by raising awareness and providing vetted cybersecurity practices to enable the organizations to mitigate cybersecurity threats to the sector. In addition, officials from HHS's Assistant Secretary for Preparedness and Response (ASPR) stated that the working group discussed the challenges associated with measuring the use and impact of the NIST framework, and approved the establishment of a task group to further investigate the issue. ASPR officials added that some of the ideas discussed included the use of surveys and identification of a set of voluntary reporting indicators. In its fiscal year 2021 budget justification, HHS noted that it participated in a Health Care SCC Cybersecurity Working Group survey that was sent to group members in June 2019. However, while the survey included a question on the extent a working group member used the framework, SCC officials stated that the survey results were not statistically meaningful. While the department has ongoing initiatives, it had yet to develop methods to determine the level and type of framework adoption. Implementing our recommendations to gain a more comprehensive understanding of the framework's use by critical infrastructure sectors is essential to the success of protection efforts.

Recommendation: The Commissioner of FDA should ensure that the FVM Program develops performance measures with associated targets and time frames for all eight of FDA's food safety- and nutrition-related objectives. (Recommendation 2)

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

Comments: As of August 2020, FDA had not fully implemented our recommendation, although the agency reported taking several steps. For example, FDA stated that implementation of Food Safety Modernization Act (FSMA) based preventive controls standards is a top priority for the agency and a key component of the Foods and Veterinary Medicine Program's strategic plan, and for this reason, FSMA-related performance metrics have been prioritized. In addition, FDA reported that in September 2019, the agency published an online Food Safety Dashboard, whose purpose is to measure the progress of each of the FSMA rules, and FDA provides regular updates to the dashboard to promote transparency to the public. FDA also stated that as of June 2020, the dashboard contains measures related to Preventive Controls and Current Good Manufacturing Practice Rules and Imported Food Safety Program, and it includes data for human and animal food and, in some cases, data starting in FY 2017. FDA added that since the FSMA rules have staggered compliance dates, the measures associated with the rules are developed in phases, and over time, the Food Safety Dashboard will be populated with additional data to show more FSMA-related outcomes. However, the recommendation is not fully implemented since our recommendation included the related objectives within the Foods and Veterinary Medicine Program's strategic plan. In August 2020, FDA told us that given the agency's 2018 reorganization, FDA has aligned the performance measures and dashboard with the FSMA rules, and the current alignment covers most of the food safety objectives within the strategic plan. FDA also reported that it is reviewing the strategic plan to ensure alignment with FDA's current priorities and structure, including the recently released New Era of Smarter Food Safety Blueprint. We will follow up with FDA and provide an update in FY 2021.

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 Secretary of HHS should ensure that IT acquisition plans or strategies are reviewed and approved according to OMB's guidance. (Recommendation 10)

Agency: Department of Health and Human Services
Status: Open

Comments: The agency agreed with our recommendation and in an April 2018 update stated that HHS has a policy for the HHS IT acquisition review process for acquisition strategies. However, as of February 21, 2020, the agency had not provided evidence that the CIO (or designee) was reviewing and approving IT acquisition plans, as required. We will continue to monitor the implementation of this recommendation.

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: 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: 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: To enhance management attention to closing out contracts, the Secretary of Health and Human Services should develop a means for department-wide oversight into components' progress in meeting their goals on closing contracts and the status of contracts eligible for closeout. (Recommendation 2)

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services agreed with the recommendation and has developed a template and instructions for quarterly reporting from its divisions. The Department identified some performance measures that it will monitor on a quarterly basis, such as contracts closed on time and total backlog. Due to competing priorities and focus on the COVID-19 response, the Department plans to provide additional steps toward progress at the next reporting cycle.

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 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: 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: The Secretaries of Agriculture, Commerce, Defense, Homeland Security, Energy, HHS, Interior, Labor, State, Transportation, Treasury, and VA; the Attorney General of the United States; the Administrators of EPA, GSA, and SBA; the Director of OPM; and the Chairman of NRC should take action to, within existing OMB reporting mechanisms, complete plans describing how the agency will achieve OMB's requirement to implement automated monitoring tools at all agency-owned data centers by the end of fiscal year 2018.

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services (HHS) concurred with our recommendation and described planned actions to implement it. Specifically, the department stated that HHS would direct its operating and staff divisions to acquire and install automated monitoring tools in all agency-owned data centers by the close of fiscal year 2018. In November 2019, HHS reported that it had 35 agency-owned data centers that the department planned to keep open. Of those 35, 22 had implemented the advanced monitoring tools. As of January 2020, we have not received a more recent update from the department about how it will meet the Data Center Optimization Initiative requirement to implement monitoring tools at the remaining 12 of its agency-owned data centers. We will continue to monitor the status of this recommendation.

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: 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 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: 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 ensure that IGCEs contain key information consistent with good cost estimating practices, the Secretaries of Education, Health and Human Services, Housing and Urban Development, and Labor should revise or clarify guidance to require that IGCEs document data sources, methodology, and assumptions, and take steps to help ensure that guidance is followed by, for example, providing training or issuing reminders to officials to include this information when developing IGCEs.

Agency: Department of Health and Human Services
Status: Open

Comments: HHS agreed with the recommendation and stated that it will revise guidance on independent government cost estimates. As of September 2020, despite numerous requests, we still have not received any information on steps HHS has taken to address this recommendation.

Recommendation: To ensure that IGCEs are optimized as a tool in the procurement planning process, the Secretaries of Defense, Education, Health and Human Services, Homeland Security, Housing and Urban Development, and Labor should take steps to ensure that, when appropriate, contracting staff document differences between IGCE and final contract award value in the contract file.

Agency: Department of Health and Human Services
Status: Open

Comments: HHS agreed with the recommendation and stated that it will revise guidance on independent government cost estimates. As of September 2020, despite numerous requests, we still have not received any information on steps HHS has taken to address this recommendation.

Recommendation: To implement the goals and policy priorities of the 2020 Federal Youth Transition Plan, the Federal Partners in Transition (FPT) workgroup--the Secretaries of HHS, Education, Department of Labor, and the Commissioner of the Social Security Administration--should develop a long-term implementation plan that includes milestones and specific agency roles and assignments.

Agency: Department of Health and Human Services
Status: Open

Comments: In July 2020, the HHS reported additional efforts by member federal agencies of the Federal Partners in Transition (FPT) to collaborate to make progress towards meeting the policy priorities outlined in the 2020 Federal Youth Transition Plan. In addition, HHS has reported that it has formalized and assigned certain FPT roles and responsibilities, is currently evaluating the 2020 plan priorities, is developing a charter to further define FPT milestones and federal agency roles and responsibilities, and the Office of Disability Employment Policy (ODEP) website will be updated to highlight FPT milestones and timelines. We are encouraged by this additional progress and anticipate we will close the recommendation once approved charter is provided and updates to the ODEP website are made as specified.

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: The Secretary of Health and Human Services should direct the Commissioner of FDA to develop a process, which may include time frames, to establish appropriate durations of use on labels of all medically important antibiotics used in food animals.

Agency: Department of Health and Human Services
Status: Open

Comments: In July 2017, as part of the agency's formal comments, HHS initially neither agreed nor disagreed with the recommendation. Subsequently, in a September 2017 letter, HHS agreed with this recommendation. In July 2018, HHS stated that FDA published a notice in the Federal Register In September 2016 requesting information from the public about how to establish appropriately targeted durations of use for therapeutic products affected by Guidance for Industry #213 with no defined duration of use. According to HHS, FDA evaluated the comments received and plans to develop a strategy to address this issue. In July 2019, HHS stated that FDA published a Request for Applications on April 1, 2019 for study proposals to help establish more targeted or defined durations of use for approved medically important antimicrobial drugs used in the feed of food-producing animals. There are currently no such products approved for use in water with an undefined duration of use. According to HHS, due to significant scientific and technical challenges, FDA anticipates that this initiative will require substantial time to fully implement so the primary objective is to update product dosage regimens to better target when and for how long the drug may be used.

Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to establish steps to increase veterinary oversight of medically important antibiotics administered in routes other than feed and water, such as injections and tablets.

Agency: Department of Health and Human Services
Status: Open

Comments: In July 2017, as part of the agency's formal comments, HHS initially neither agreed nor disagreed with the recommendation. Subsequently, in a September 2017 letter, HHS agreed with this recommendation. In July 2018, HHS stated that FDA recognizes that a limited number of medically important antimicrobial products, available in dosage forms other than feed or water (e.g., injectable), continue to be marketed as OTC products and the agency intends to work with the sponsors to put these products under veterinary oversight. In July 2019, HHS stated that FDA released a broad 5-year plan in September 2018 outlining steps to support stewardship of medically important antimicrobials in veterinary settings. As part of that plan, FDA intends to publish a draft strategy, likely in the form of draft guidance for industry, to bring all dosage forms (such as injectables and tablets) of medically important antimicrobial drugs under veterinary oversight. The draft strategy will also provide a framework, including proposed timelines, for transitioning from over-the-counter to prescription marketing status for all approved medically important antimicrobial drugs that are not yet subject to veterinary oversight. FDA plans to issue this draft strategy no later than the end of fiscal year 2019. In conjunction with issuing the draft strategy, FDA intends to publish a list of affected new animal drug applications.

Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to develop performance measures and targets for actions to manage the use of antibiotics such as revising the veterinary feed directive and developing guidance documents on judicious use.

Agency: Department of Health and Human Services
Status: Open

Comments: In July 2017, as part of the agency's formal comments, HHS initially neither agreed nor disagreed with the recommendation. Subsequently, in a September 2017 letter, HHS agreed with this recommendation. In July 2018, HHS noted that FDA has taken steps to develop performance measures and targets. According to HHS, FDA issued a final rule in May 2016 revising annual reporting requirements for drug sponsors of antimicrobials sold or distributed for use in food-producing animals to obtain estimates of sales broken out by major food-producing species (i.e., cattle, swine, chickens, and turkeys). Additionally, in August 2017, FDA published a paper proposing the use of a biomass denominator to adjust annual data on the volume of antimicrobials sold or distributed for use in food-producing animals in the United States. According to HHS, this adjusted estimate will provide insight into broad shifts in the volume of antimicrobials sold for use in food-producing animals. FDA is also funding two grants for antimicrobial use data collection. These collection efforts are intended to provide part of the baseline information on antimicrobial use practices in the four major food-producing animal groups (i.e., cattle, swine, chickens, and turkeys), which is a critical element in measuring overall impact of the agency's judicious use strategy. FDA expects these data collection efforts to provide important information on methodologies to help optimize long-term strategies to collect and report such antimicrobial use data. In addition, FDA has been working in close collaboration with USDA, including providing input on recent surveys administered by USDA to collect information on antimicrobial use on farms. In July 2019, according to HHS, FDA agrees that performance measures and targets are needed to help gauge the success of antimicrobial stewardship efforts. While the agency continues to work on developing such measures and targets, FDA reported a decrease in domestic sales and distribution of all medically important antimicrobials intended for use in food-producing animals (e.g. decreased by 33 percent from 2016 through 2017). HHS noted that the reduction in sales volume is an important indicator that ongoing efforts to support antimicrobial stewardship are having a significant impact even though sales data do not necessarily reflect antimicrobial use.

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: 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 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 facilitate the analysis of gaps between current skills and future needs, the development of strategies for filling the gaps, and succession planning, the Secretary of Health and Human Services should require the Chief Information Officer, Chief Human Capital Officer, and other senior managers as appropriate to address the shortfalls in IT workforce planning noted in this report, including the following actions: (1) establish and maintain a workforce planning process inclusive of all staff; (2) develop staffing requirements for all positions; (3) assess staffing needs regularly; (4) assess gaps in competencies and staffing for all components of the workforce; (5) develop strategies and plans to address gaps in competencies and staffing; (6) implement activities that address gaps, including an IT acquisition cadre, if justified and cost-effective; (7) monitor the department's progress in addressing competency and staffing gaps; and (8) report to department leadership on progress in addressing competency and staffing gaps.

Agency: Department of Health and Human Services
Status: Open

Comments: The department agreed with our recommendation and identified plans for (1) collecting and analyzing additional workforce data and (2) conducting targeted recruitment, staff planning, career development, and training. In October 2019 (in GAO-20-129), we reported the results of our evaluation of the department's progress in implementing the eight IT workforce planning activities. Specifically, we reported that the department had substantially implemented the activity to develop competency and staffing requirements, partially implemented three other activities, and either minimally or not implemented the remaining four activities. We will continue to monitor the department's efforts to address our recommendation.

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 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 improve the certification of adequate incremental development, the Secretaries of Defense, Education, Health and Human Services, and the Treasury should direct their CIOs to establish a department policy and process for the certification of major IT investments' adequate use of incremental development, in accordance with OMB's guidance on the implementation of the Federal Information Technology Acquisition Reform Act.

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services (HHS) concurred with our recommendation and has taken steps to establish a department policy and process for the certification of major IT investments' use of incremental development. Specifically, in September 2020, HHS officials reported that they have established a draft policy and anticipate publishing the finalized guidance by March 2021. We will continue to evaluate HHS's progress in implementing this recommendation.

Recommendation: To help improve tribes' ability to maintain safe, stable, and permanent care for children, the Secretary of Health and Human Services should direct the Children's Bureau to explore the reasons for low tribal participation and identify actions to increase this participation in the title IV-E Guardianship Assistance Program.

Agency: Department of Health and Human Services
Status: Open

Comments: HHS agreed with this recommendation. HHS reported that it would take several actions: 1) task the Tribal Workgroup with identifying reasons for low tribal participation in GAP and identifying actions to increase participation in GAP; 2) improve its website offerings on Tribal IV-E, including providing the briefing materials as well direct IV-E and pass-through related products created by the CB Central and Regional Offices and the Capacity Building Center for Tribes; 3) improve coordination with non-governmental organizations that provide technical assistance and direct outreach to tribes for Title IV-E; and 4) encourage states to work with tribes on GAP. HHS noted that some states have already developed GAP frequently asked questions, practice guides, and other GAP support products to raise awareness and engage tribal interest in GAP. GAO awaits documentation that these actions have been completed. The agency also hopes to host a national tribal consultation to solicit feedback and determine priorities to address tribal participation in GAP; and develop a strategy for serving tribes interested in and implementing IV-E, including GAP, to be posted on the website. GAO will close this recommendation when the agency shows that these efforts have been completed.

Recommendation: To help ensure HHS has reliable data on SGEs not serving on federal boards, the Secretary of HHS should take steps to improve the reliability of data on SGEs not serving on boards. For example, the agency could reconcile human capital data with general counsel and ethics office data, or issue clarifying guidance to human capital staff on appropriately identifying SGEs in human capital databases.

Agency: Department of Health and Human Services
Status: Open

Comments: In October 2016, HHS submitted its action plan to address GAO's recommendations. At that time, HHS stated the agency was reviewing its internal policies and procedures related to the hiring of special government employees not serving on boards to identify policy options that might improve data reliability. In January 2017, the Office of Government Ethics issued its Ethics Program Review of HHS and commented on ongoing and planned efforts by HHS to address challenges associated with identifying Special Government Employees who do not serve on federal advisory committees. Ongoing efforts include internal coordination between the Office of General Counsel-Ethics Division and human resource officials to implement new requirements based on 5 CFR part 2638. We are following up with HHS to determine the status of actions on the new requirements. As of September 2019, HHS has not responded to our requests for an update on their actions to respond to this recommendation. In May 2020, HHS noted that its Office of Human Resources has been responding to the COVID-19 pandemic and therefore has not been able to provide an update on this recommendation. HHS expects to provide us with an update in July 2020. We contacted the agency for an update and are awaiting a response as of September 1, 2020.

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 better ensure that the Dashboard ratings more accurately reflect risk, the Secretaries of the Departments of Agriculture, Education, Energy, Health and Human Services, the Interior, State, and Veterans Affairs; and the Director of the Office of Personnel Management should direct their CIOs to factor active risks into their IT Dashboard CIO ratings.

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services (HHS) agreed with the recommendation and, in a written response, stated that it updated its CIO evaluation methodology to measure active risks in areas such as budget variance, performance, policy and governance compliance, risk management, and contract risk. HHS submitted a draft version of this methodology in June 2018. Upon reviewing this documentation, however, we did not see evidence that the department was factoring active risks into its CIO ratings. In May 2019, HHS officials stated that they planned to update their CIO rating methodology to focus on active risk; however, department documentation from August 2020 stated that the new CIO rating methodology is still in draft form and is not finalized. We will continue to monitor HHS's efforts in implementing this recommendation.

Recommendation: To better ensure that the Dashboard ratings more accurately reflect risk, the Secretaries of the Departments of Agriculture, Commerce, Defense, Education, Energy, Health and Human Services, Homeland Security, State, Transportation, the Treasury, Veterans Affairs; the Administrator of the Environmental Protection Agency; and the Commissioner of the Social Security Administration should direct their CIOs to ensure that their CIO ratings reflect the level of risk facing an investment relative to that investment's ability to accomplish its goals.

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services (HHS) agreed with the recommendation and, in a written response, stated that it updated its CIO evaluation methodology to measure active risks in areas such as budget variance, performance, policy and governance compliance, risk management, and contract risk. According to HHS, these risk areas reflect both internal and external risks that affect an investment's ability to accomplish its goals. HHS submitted a draft version of this methodology in June 2018. While this documentation showed that HHS factored investment qualities related to overall project riskiness, it did not specify that active investment risks were also being factored as part of the evaluation. Without an additional focus on active risk, this methodology is unlikely to ensure that HHS's CIO ratings reflect the level of risk facing an investment. In May 2019, HHS officials stated that they planned to update their CIO rating methodology; however, per HHS documentation dated August 2020, this new methodology is still in draft form and is not finalized. We will continue to monitor HHS's efforts 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: To develop a better understanding of meat and poultry sanitation workers' injuries and illnesses, the Secretary of Health and Human Services should direct the Director of the Centers for Disease Control and Prevention to have the National Institute for Occupational Safety and Health (NIOSH) conduct a study of the injuries and illnesses these workers experience, including their causes and how they are reported. Given the challenges to gaining access to this population, NIOSH may want to coordinate with the Occupational Safety and Health Administration to develop ways to initiate this study.

Agency: Department of Health and Human Services
Status: Open

Comments: HHS concurred with this recommendation and noted the previous difficulties NIOSH has had gaining access to these workplaces and the potential resource commitment involved in conducting such a study. We acknowledge this access challenge and noted in our report that OSHA has negotiated access for NIOSH in other industries, hence the rationale for recommending that NIOSH may want to coordinate with OSHA. In February 2020, NIOSH reported it met with industry associations to discuss areas of mutual interest for research on worker safety in poultry plants. However, according to NIOSH, the advent of COVID-19 and its challenges have limited plans for field studies for FY20. During the COVID-19 epidemic NIOSH informed us its representatives have: (1) created COVID-19 safety guidelines with OSHA and (2) performed more than 30 meat and poultry worksite evaluations focusing on the prevention of COVID-19. NIOSH notes that it continues to have an interest in learning more about and providing assistance to minimize various types of illnesses and injuries that may affect meat and poultry sanitation workers, and at some point in the future they hope to "re-initiate" their interactions with stakeholders such as the National Chicken Council and US Egg & Poultry Association on the study of peracetic acid exposure in the poultry processing industry. Our recommendation was aimed at increasing the understanding of the various types of illnesses and injuries that are common among meat and poultry sanitation workers, including their causes and how they are reported. We look forward to hearing about future studies that address this topic.

Recommendation: To help ensure vulnerable unaccompanied children receive child advocate services, the Secretary of the Department of Health and Human Services should direct ORR to develop a monitoring process that includes: (1) regularly reviewing referrals to the program contractor, including identifying which care providers in locations with a child advocate program do not make referrals; and (2) reviewing information on the children the program contractor determines it is unable to serve.

Agency: Department of Health and Human Services
Status: Open

Comments: In June 2016, the Office of Refugee Resettlement (ORR) reported that it was working with the child advocate contractor to develop standard operating procedures (SOP) to assign child advocates for children. In February 2020, ORR reported that the finalized SOPs are being implemented. Agency officials stated that they are reviewing program referrals through monthly reporting and calls with the contractor. ORR officials also said they allow the contractor to determine which unaccompanied children are provided a child advocate and there are insufficient resources to assign advocates to all children that are referred. In August 2020, ORR reported that the agency is in the process of developing a new case management system that will enhance its monitoring of the child advocate program, including the ability to analyze child advocate referral data. This system is expected to be fully operational in late 2021.

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 help ensure continued progress in the implementation of effective cloud computing SLAs, the Secretaries of Health and Human Services, Homeland Security, Treasury, and Veterans Affairs should direct appropriate officials to develop SLA guidance and ensure key practices are fully incorporated as the contract and associated SLAs expire.

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services (HHS) concurred with our recommendation and reported that the department was in the process of addressing it. Specifically, a HHS official reported in August 2020 that the department had created a team to address cloud computing best practices and intended to finalize guidance on SLA key practices by June 2021. We will continue to evaluate the department's progress in implementing this recommendation.

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 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: 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: To help ensure that FDA's IT strategic planning activities are successful in supporting the agency's mission, goals, and objectives, the Commissioner of FDA should require the CIO to implement the plan to ensure that expected outcomes of the agency's key IT initiatives are achieved.

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

Comments: According to agency officials, FDA's CIO met with the FDA Commissioner in 2016 where the updated IT strategic plan was reviewed and approved. The Commissioner identified key IT initiatives to be implemented within FY2017 and incorporated them into the CIO's performance management appraisal program. According to officials, the Commissioner requires the CIO to implement a plan to ensure that expected outcomes of the agency's key IT initiatives are achieved. Although FDA provided us with an excel spreadsheet that identifies IT initiatives at the agency's weekly FDA project meeting, we requested additional documentation regarding the plan the CIO is required to implement to ensure that expected outcomes of the agency's key IT initiatives are fulfilled. We contacted FDA in September and December 2019 and January 2020 to obtain additional information on the actions taken to implement the recommendation, but have not received a response. We will update the recommendation when additional information is obtained.

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 better monitor and provide a basis for improving the effectiveness of cybersecurity risk mitigation activities, informed by the sectors' updated plans and in collaboration with sector stakeholders, the Secretaries of Agriculture and Health and Human Services (as co-SSAs) should direct responsible officials to develop performance metrics to provide data and determine how to overcome challenges to monitoring the food and agriculture sector's cybersecurity progress.

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services (HHS), as the co-sector specific agency for the food and agriculture sector, with the Department of Agriculture (USDA) continues to implement cybersecurity-related activities for the sector. In particular, through the sector coordination council, they routinely share best practices and informational bulletins from the Department of Homeland Security on cybersecurity with sector stakeholders via the Homeland Security Information Network. In addition, at semi-annual council meetings, they have hosted roundtable discussions of cybersecurity challenges and best practices. No evidence of performance metrics to track and report on the SSAs' activities or the sector's cybersecurity progress has been provided. As HHS and USDA continue to carry out their sector-specific agency role, we will continue to monitor their efforts and associated performance metrics to be developed to demonstrate the effectiveness of these activities

Recommendation: To ensure effective implementation of the Inclusion Policy in a manner consistent with the Revitalization Act's provisions regarding the design of certain clinical trials, the NIH Director should report on this summary data and the results of this analysis in NIH's regular biennial report to Congress on the inclusion of women in research.

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

Comments: In August 2020, NIH reported that summary data as described in our Recommendation 4--that is, data and analysis on awardees' plans to conduct valid analysis by sex/gender--will be included in the 2019-2020 version of this publication, which the agency expects will be published in October 2021. We will continue to monitor NIH's actions on this matter.

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 help ensure that FDA has relevant and timely information to support management decisions, including the critical information necessary to ensure the safety and effectiveness of drugs compounded for animals, the Secretary of Health and Human Services should direct the Commissioner of the FDA to develop policy or guidance for agency staff that specifies circumstances under which FDA will or will not enforce compounding regulations for animals and clearly define key terms.

Agency: Department of Health and Human Services
Status: Open

Comments: In November 2019, FDA released for public comment its new Draft Guidance for Industry #256 - Compounding Animal Drugs from Bulk Drug Substances. The draft guidance describes FDA's policy regarding the compounding of animal drugs from bulk drug substances including the conditions under which FDA does not intend to take enforcement action for violations of the Federal Food, Drug, and Cosmetic Act's requirements for approval, adequate directions for use, and current Good Manufacturing Practices. We will review the updated guidance when it is finalized and determine if it addresses this recommendation. In August 2020, FDA indicated that, in response to numerous requests from external stakeholders, the comment period on the draft guidance has been extended to October 2020. Once the comments have been reviewed, FDA anticipates finalizing the guidance by the end of calendar year 2021.

Recommendation: To help ensure that FDA has relevant and timely information to support management decisions, including the critical information necessary to ensure the safety and effectiveness of drugs compounded for animals, the Secretary of Health and Human Services should direct the Commissioner of the FDA to consistently document the bases for FDA's decisions about how or whether it followed up on warning letters, adverse event reports, and complaints about drug compounding for animals.

Agency: Department of Health and Human Services
Status: Open

Comments: In July 2019, FDA reported to GAO that when the Draft Guidance for Industry #256 was issued that calendar year, FDA intended to develop a risk-based compliance program to address compounding of animal drugs from bulk drug substances. As part of that compliance program, FDA reported that it intended to consistently document the basis for its decisions about what actions are taken, for example, warning letters, adverse event reports, and complaints. In August 2020, FDA reported that a working group has been formed to develop a risk-based compliance strategy, which will include a process for documenting the basis for FDA's decisions about how or whether it followed up on warning letters, adverse event reports, and complaints about drug compounding for animals. FDA anticipates implementing this strategy simultaneously with the finalization of Guidance for Industry #256, which is anticipated to occur at the end of calendar year 2021. We will follow-up with FDA regarding these actions and determine if the actions address our recommendation.

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 increase the efficiency and improve the accuracy of the interagency UAC referral and placement process, the Secretaries of Homeland Security and Health and Human Services should jointly develop and implement a documented interagency process with clearly defined roles and responsibilities, as well as procedures to disseminate placement decisions, for all agencies involved in the referral and placement of UAC in HHS shelters.

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

Comments: Since our 2015 report, DHS and HHS developed two documents to guide interagency procedures related to the processing of UAC. Specifically, in April 2018, HHS and DHS established a memorandum of agreement regarding information sharing for UAC. Subsequently, on July 31, 2018, DHS and HHS issued a Joint Concept of Operations to memorialize interagency policies, procedures, and guidelines related to the processing of UAC. However, in February 2020, we reported that DHS and HHS officials' indicated that, in practice, the agencies have not resolved long-standing differences in opinion about whether and how agencies are to share information, and what type of information is needed to inform decisions about the care and placement of UAC. In commenting on our draft report, DHS stated that its components are working with HHS to document current information sharing practices, to validate remaining information sharing gaps, and to draft a joint plan between DHS and HHS to ensure that HHS receives information needed to make decisions for UAC. In their comments, HHS officials stated that they intend to reach out to counterparts at DHS in June 2020 to discuss potential periodic updates to the Joint Concept of Operations. In August 2020, DHS informed us that the department is working with HHS to document current information sharing practices, validate gaps, and draft a joint plan between DHS and HHS, among other actions. DHS estimates that it will complete these actions by March 31, 2021. To fully address the recommendation, DHS and HHS should ensure that they have implemented procedures aimed at improving the efficiency and accuracy of the interagency UAC referral and placement process.

Recommendation: To ensure consistent implementation of the Buy Indian Act procurement authority across the agencies and to enhance oversight of implementation of the Act at regional offices, the Secretaries of the Interior and Health and Human Services should direct the Bureau of Indian Affairs and Indian Health Service respectively, to clarify and codify their policies related to the priority for use of the Buy Indian Act, including whether the Buy Indian Act should be used before other set-aside programs.

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services concurred with this recommendation. The Indian Health Service (IHS) informed GAO that in order to clarify and codify the policies related to priority for use of the Buy Indian Act, formal rulemaking was required. IHS published the intent to promulgate the regulation in the Fall 2019 and Spring 2020 Unified Agendas. According to IHS officials, the timeline for completion of the new regulation is December 31, 2020.

Recommendation: To ensure consistent implementation of the Buy Indian Act procurement authority across the agencies and to enhance oversight of implementation of the Act at regional offices, the Secretaries of the Interior and Health and Human Services should direct the Bureau of Indian Affairs and Indian Health Service respectively, to collect data on regional offices' implementation of key requirements, such as challenges to self-certification.

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services concurred with this recommendation. The Indian Health Service (IHS) informed GAO that in order to clarify and codify policies related to priority for use of the Buy Indian Act, formal rulemaking was required. IHS published the intent to promulgate the regulation in the Fall 2019 and Spring 2020 Unified Agendas. Further, the officials stated that once the new Buy Indian regulation is promulgated, IHS plans to identify a plan to collect data on area office implementation of key policy requirements, including monitoring authentication of contractor credentials. According to IHS officials, due to limitations within the Federal Procurement Data System- Next Generation IHS is unable to collect the necessary data until the rule is promulgated.

Recommendation: To help the department effectively manage spending on mobile devices and services, the Secretary of Health and Human Services should ensure procedures to monitor and control spending are established department-wide. Specifically, ensure that (1) procedures include assessing devices for zero, under, and over usage; (2) personnel with authority and responsibility for performing the procedures are identified; and (3) the specific steps to be taken to perform the process are documented.

Agency: Department of Health and Human Services
Status: Open

Comments: As of December 2019, the Department of Health and Human Services had not implemented this recommendation. We will continue to monitor the department's implementation of this recommendation.

Recommendation: To help improve CMS's process for establishing relative values for Medicare physicians' services, the Administrator of CMS should better document the process for establishing relative values for Medicare physicians' services, including the methods used to review RUC recommendations and the rationale for final relative value decisions.

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

Comments: To help improve the Centers for Medicare & Medicaid Service's (CMS) process for establishing relative values for Medicare physicians' services, in May 2015 we recommended that the Administrator of CMS better document the process, including the methods used to review recommendations from the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC) and the rationale for final relative value decisions. CMS concurred with this recommendation, stating that CMS establishes relative values for new, revised, and potentially misvalued physicians' services based on its review of a variety of sources of information, including the RUC. At that time, CMS officials told us the agency was working to improve the transparency of its process by proposing and finalizing changes to the process in the annual rule for the Physician Fee Schedule. Officials estimated that this process would take several years to complete. In order to close this recommendation as implemented, CMS will need to demonstrate that it has improved its internal and external documentation of its process for establishing relative values. As of June 2020, GAO was still waiting on confirmation from CMS that it had completed its enhancement process for establishing relative values for Medicare physicians' services in a way that would allow for greater transparency and documentation. CMS will need to demonstrate that it has improved its internal and external documentation for establishing relative values in order for GAO to close the recommendation. CMS officials agreed the recommendation should remain open as progress continues.

Recommendation: To help improve CMS's process for establishing relative values for Medicare physicians' services, the Administrator of CMS should develop a process for informing the public of potentially misvalued services identified by the RUC, as CMS already does for potentially misvalued services identified by CMS or other stakeholders.

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

Comments: To help improve the Centers for Medicare & Medicaid Service's (CMS) process for establishing relative values for Medicare physicians' services, in May 2015 we recommended that the Administrator of CMS develop a process for informing the public of potentially misvalued services identified by the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC), as CMS already does for potentially misvalued services identified by CMS or other stakeholders. CMS did not concur with this recommendation, asserting that the RUC is completely independent of CMS, and as such CMS has no authority to set the RUC's agenda for which services are reviewed. As of June 2020, CMS had not changed its position on the recommendation. We continue to believe that CMS needs to inform the public of potentially misvalued services identified by the RUC, as it does for potentially misvalued services identified by other stakeholders. We acknowledge that in 2017 CMS changed its process for establishing relative values by including proposed values for almost all services in the annual proposed rulemaking for the Physician Fee Schedule, which means that the changes in values for potentially misvalued services identified by the RUC are open for public comment before they become effective. However, we continue to believe CMS should inform stakeholders of these potentially misvalued services before CMS receives RUC recommendations for them and subsequently publishes the values in the proposed rule. Doing so would give stakeholders the same amount of time they have to provide input on potentially misvalued services identified by other stakeholders.

Recommendation: To help improve CMS's process for establishing relative values for Medicare physicians' services, the Administrator of CMS should incorporate data and expertise from physicians and other relevant stakeholders into the process as well as develop a timeline and plan for using the funds appropriated by the Protecting Access to Medicare Act of 2014.

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

Comments: To help improve the Centers for Medicare & Medicaid Service's (CMS) process for establishing relative values for Medicare physicians' services, in May 2015 we recommended that the Administrator of CMS incorporate data and expertise from physicians and other relevant stakeholders into the process, as well as develop a timeline and plan for using the funds appropriated by the Protecting Access to Medicare Act of 2014 (PAMA). CMS concurred with this recommendation, stating that stakeholders have the opportunity each year to nominate potentially misvalued services for review through a public nomination process. In August 2017, CMS officials reported that the final rulemaking for the 2017 Physician Fee Schedule included a data collection effort using PAMA funds and other authorities that will help furnish data to help in valuations for more than half of physician services. However, this effort pertains to global services, which are a specific type of service under the Physician Fee Schedule that include global, professional, and technical components, and does not apply to non-global services, which encompass almost half of physician services. Officials also reported that they had awarded a contract to explore data collection on practice expense and methodologies for using such data when valuing services in the Physician Fee Schedule. However, CMS did not indicate a specific timeline and plan for using the PAMA funds, just that the agency would continue to use these funds to explore more ways to gain improved data. In March 2018, CMS reported that it now incorporates data and expertise from relevant stakeholders-apart from the RUC-into its process for establishing relative values by including any new, revised, or potentially misvalued values in the annual proposed rulemaking, instead of establishing them on an interim final basis in the final rule. This means that the changes in values for services will be open for public comment prior to the implementation of changes to payment. We acknowledge that CMS has made progress towards meeting our recommendation by changing its process to allow for public comments on proposed changes to relative values before they go into effect. CMS has also made progress by beginning to use PAMA funds to assist with valuing global services and exploring avenues for collecting practice expense data. To close this recommendation, we need documentation that CMS has started to incorporate data more broadly into its process for establishing relative values and that it has a documented timeline and plan for how it will use the funds appropriated by the Protecting Access to Medicare Act of 2014. As of June 2020, we had not received this documentation.

Recommendation: To improve agencies' guidance development, review, evaluation, and dissemination processes for non-significant guidance, we recommend that the Secretaries of USDA, HHS, DOL, and Education should improve the usability of selected component websites to ensure that the public can easily find, access, and comment on online guidance. These improvements could be informed by the web and customer satisfaction metrics that components have collected on their websites. Some examples of changes that could facilitate public access to online guidance include (1) improving website usability by clarifying which links contain guidance; (2) highlighting new or important guidance; and (3) ensuring that posted guidance is current.

Agency: Department of Health and Human Services
Status: Open

Comments: In comments printed in the April 2015 final report, HHS concurred with the recommendation and stated that it would review current links to guidance documents and explore ways to enhance their visibility and usability. As of June 2020, GAO is working with HHS officials to obtain additional updates and documentation regarding the department's implementation of this recommendation.

Recommendation: To improve the transparency and accountability of HHS's section 1115 Medicaid demonstration approval process, and to ensure that federal Medicaid funds for the demonstrations do not duplicate other federal funds, the Secretary of Health and Human Services should issue criteria for assessing whether section 1115 expenditure authorities are likely to promote Medicaid objectives.

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services (HHS) partially concurred with this recommendation and has taken some steps to address the problems GAO identified. Initially, in August 2015, HHS posted on its website general criteria for assessing whether Medicaid section 1115 demonstration expenditure authorities are likely to promote Medicaid objectives, but GAO found the general criteria were not sufficiently specific. HHS later removed these criteria from its website and replaced them with six broad areas of reform that HHS encourages states to consider. As of January 2020, HHS does not have specific criteria for approving section 1115 expenditure authorities, but officials noted that the agency had begun including in approval letters the agency's rationale for approving specific expenditure authorities. GAO considers this a positive step towards improving the transparency of HHS's approval decisions, and if implemented consistently would address the intent of GAO's recommendation. HHS officials indicated that this step would be included in written protocols the agency is drafting but did not have a date for their completion. If these protocols are completed and consistently implemented, HHS's bases for its approvals of expenditure authorities, which can amount to billions of dollars in federal spending, will be more transparent. We will continue to monitor HHS's actions in response to this recommendation.

Recommendation: To improve the transparency and accountability of HHS's section 1115 Medicaid demonstration approval process, and to ensure that federal Medicaid funds for the demonstrations do not duplicate other federal funds, the Secretary of Health and Human Services should ensure the application of these criteria is documented in all HHS's approvals of section 1115 demonstrations, including those approving new or extending or modifying existing expenditure authorities, to inform internal and external stakeholders, including states, the public, and Congress, of the basis for the agency's determinations that approved expenditure authorities are likely to promote Medicaid objectives.

Agency: Department of Health and Human Services
Status: Open

Comments: HHS agreed with this recommendation and, as of January 2020, had taken some steps to ensure that the bases for its approval decisions are documented in all approvals of section 1115 demonstrations. In December 2017, HHS's Centers for Medicare & Medicaid Services (CMS) issued a letter to state Medicaid officials, stating it had begun requesting additional documentation of the demonstration purposes being served by certain types of previously approved funding in demonstration proposals. Additionally, the agency noted it was taking certain steps to ensure that only allowable costs were matched by federal Medicaid funds. In April 2018, CMS officials stated that the agency had begun addressing in approval documents how each intervention proposed by the state was determined to be likely to promote Medicaid objectives. Officials reported that this step would be included in formal written protocols that outline the agency's procedures for application review and preparation of approval documents for section 1115 demonstrations, but as of January 2020, the agency did not have time frames for the completion of these protocols. If CMS completes and implements the written protocols, stakeholders should be able to more easily and consistently assess the agency's decisions. We will continue to monitor CMS's efforts in this area.

Recommendation: To improve CMS's oversight of Medicaid payments, the Administrator of CMS should take steps to ensure that states report accurate provider-specific payment data that include accurate unique national provider identifiers (NPI).

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

Comments: In November 2019, CMS issued a proposed rule that the agency said would promote state accountability, improve federal oversight, and strengthen the fiscal integrity of the Medicaid program. Among other things, the proposed rule would require states to report supplemental payments made to individual providers; furthermore, it would require states to include the National Provider Identifier (NPI) number-a unique 10-digit identification number assigned to health care providers. GAO will continue to monitor the status of the proposed rule and will review a final rule, if one is issued, to determine the extent it addresses the recommendation.

Recommendation: To improve CMS's oversight of Medicaid payments, the Administrator of CMS should develop a policy establishing criteria for when such payments at the provider level are economical and efficient.

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

Comments: In November 2019, CMS issued a proposed rule that the agency said would require states to demonstrate to CMS that supplemental payments to individual providers are economical and efficient and also require states to end and then seek CMS approval to renew supplemental payments every three years. GAO will monitor the status of the proposed rule and will review a final rule, if one is issued, to determine the extent to which it addresses the recommendation.

Recommendation: To improve CMS's oversight of Medicaid payments, the Administrator of CMS should, once criteria are developed, develop a process for identifying and reviewing payments to individual providers in order to determine whether they are economical and efficient.

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

Comments: In November 2019, CMS issued a proposed rule that the agency said would require states to demonstrate to CMS that supplemental payments to individual providers are economical and efficient and also require states to end and then seek CMS approval to renew supplemental payments every three years. GAO will monitor the status of the proposed rule and will review a final rule, if one is issued, to determine the extent to which it addresses the recommendation.

Recommendation: To help ensure the safety of food imported into the United States, the Commissioner of Food and Drugs should complete an analysis to determine the annual number of foreign food inspections that is sufficient to ensure comparable safety of imported and domestic food. If the inspection numbers from that evaluation are different from the inspection targets mandated in FSMA, FDA should report the results to Congress and recommend appropriate legislative changes.

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

Comments: On March 25, 2020, GAO staff met with FDA officials to discuss the status of the recommendation. FDA officials said that they cannot meet the number of foreign inspections required under FSMA due to capacity constraints, and FDA's current strategy for the safety of imported food relies on a "cumulative oversight" approach involving multiple programs (including the Third-Party Certification Program, the Foreign Supplier Verification Program, the Voluntary Qualified Importer Program, and systems recognition), in addition to foreign inspections. FDA officials said that it could be a number of years before these programs are fully implemented and that FDA will provide GAO with more specific status updates on the implementation and monitoring of each of these programs in future responses to this recommendation. Because FDA is still implementing their cumulative oversight approach and has not reported the number of foreign inspections required to ensure imported food safety, the recommendation remains open.

Recommendation: To help determine if programs are effective at supporting those individuals with serious mental illness, the Secretaries of Defense, Health and Human Services, Veterans Affairs, and the Attorney General--which oversee programs targeting individuals with serious mental illness--should document which of their programs targeted for individuals with serious mental illness should be evaluated and how often such evaluations should be completed.

Agency: Department of Health and Human Services
Status: Open

Comments: HHS did not concur with this recommendation. The Helping Families in Mental Health Crisis Reform Act of 2016 enacted in December 2016 included a requirement for HHS to develop a strategy for conducting ongoing evaluations of programs related to mental illness--including serious mental illness--and substance use disorders. HHS has said that it is in the process of preparing a report that identifies key programs and activities across the department, as well as summarizes data on those programs and develops criteria for use in prioritizing programs for evaluation. However, as of June 2019, HHS has not indicated that this report is complete or provided a copy to GAO. We will continue to monitor HHS's efforts in this regard and look for documentation of HHS plans for future evaluations of programs for individuals with serious mental illness.

Recommendation: To improve consumers' access to relevant and understandable information on the cost and quality of health care services, the Secretary of HHS should direct the Administrator of CMS to include in the CMS Compare websites, to the extent feasible, estimated out-of-pocket costs for Medicare beneficiaries for common treatments that can be planned in advance.

Agency: Department of Health and Human Services
Status: Open

Comments: As of September 2019, 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: To improve consumers' access to relevant and understandable information on the cost and quality of health care services, the Secretary of HHS should direct the Administrator of CMS to organize cost and quality information in the CMS Compare websites to facilitate consumer identification of the highest-performing providers, such as by listing providers in order based on their performance.

Agency: Department of Health and Human Services
Status: Open

Comments: As of September 2019, 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: To improve consumers' access to relevant and understandable information on the cost and quality of health care services, the Secretary of HHS should direct the Administrator of CMS to include in the CMS Compare websites the capability for consumers to customize the information presented, to better focus on information relevant to them.

Agency: Department of Health and Human Services
Status: Open

Comments: As of September 2019, 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: To improve consumers' access to relevant and understandable information on the cost and quality of health care services, the Secretary of HHS should direct the Administrator of CMS to develop specific procedures and performance metrics to ensure that CMS's efforts to promote the development and use of its own and others' transparency tools adequately address the needs of consumers.

Agency: Department of Health and Human Services
Status: Open

Comments: As of September 2019, 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: To better inform users of the annual monitoring report about the frequency and scope of pesticide tolerance violations, the Secretary of Health and Human Services should direct the Commissioner of FDA to disclose in the agency's annual pesticide monitoring program report which pesticides with EPA-established tolerances the agency did not test for in its pesticide monitoring program and the potential effect of not testing for those pesticides.

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

Comments: In February 2020, FDA said that the recommendation should be closed as not implemented. FDA has previously said that it remained concerned that the disclosure of pesticides for which FDA does not test would enable users to more easily circumvent the pesticide monitoring program, which could jeopardize public health and, at a minimum, would undermine FDA's law enforcement efforts. In addition, FDA said that it discloses in its annual reports all pesticides tested for within the reports' annual scope as required by the Pesticide Monitoring Improvements Act of 1988. FDA's annual reports also clarify that not all pesticides for which EPA has established tolerances were analyzed. FDA said that the Pesticide Monitoring Improvements Act of 1988 does not specifically direct the agency to report information on untested pesticides with EPA-established tolerances. We continue to believe that disclosing the pesticides that are not included in FDA's testing program would be consistent with OMB best practices for reporting limitations relevant to analyzing and interpreting results from a data collection effort. In particular, we continue to believe that FDA should be more transparent about the potential effect of not testing for all pesticides for which EPA has established tolerances. We also note that the Department of Agriculture's Food Safety and Inspection Service implemented a similar recommendation to disclose information about its pesticide monitoring program. As a result, we are keeping this recommendation open.

Recommendation: To ensure that MA encounter data are of sufficient quality for their intended purposes, the Administrator of CMS should establish specific plans and time frames for using the data for all intended purposes in addition to risk adjusting payments to MAOs.

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

Comments: HHS generally agreed with this recommendation. Although CMS reports using MA encounter data for purposes other than risk adjustment, as of February 2020, it has not fully developed specific plans and time frames with dates for all uses. CMS reports that it has begun testing the use of MA encounter data for public health purposes, such as identifying beneficiaries with a history of opioid-related overdose and with other conditions, such as cancer and sickle cell. Further, CMS uses MA encounter data to help identify beneficiaries at risk in areas affected by public health emergencies. CMS reports that its Office of the Actuary (OACT) has used MA encounter data to analyze MA beneficiary utilization of certain Part B drugs. Further, OACT reports that it intends to assess other areas where it could use MA encounter data, such as analyses comparing Medicare fee-for-service and MA. As of February 2020, the agency has not developed specific plans and time frames for this and other intended purposes. For example, although CMS intends to use MA encounter data for program integrity purposes, it has not yet developed specific plans and time frames to do so. We will continue to monitor CMS's progress in developing specific plans and time frames with dates for all intended purposes of MA encounter data.

Recommendation: To ensure that MA encounter data are of sufficient quality for their intended purposes, the Administrator of CMS should complete all the steps necessary to validate the data, including performing statistical analyses, reviewing medical records, and providing MAOs with summary reports on CMS's findings, before using the data to risk adjust payments or for other intended purposes.

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

Comments: HHS generally agreed with this recommendation, however, HHS did not commit to completing data validation before using MA encounter data for risk adjustment. As of February 2020, CMS has continued to make progress in examining the completeness and accuracy of MA encounter data, but more work remains to fully validate these data. CMS has developed and is implementing an MA Encounter Data Integrity and Monitoring plan, which includes data analysis, guidance, and monitoring. As part of this plan, CMS has established preliminary performance metrics for MA encounter data completeness and accuracy. CMS is also conducting analyses related to accuracy and completeness, but has not established performance benchmarks for these analyses. While the agency plans to communicate findings from the analyses to Medicare Advantage organizations, it has not yet done so. Finally, CMS has not verified MA Encounter data by reviewing medical records. While these steps are encouraging, without fully validating the completeness and accuracy of MA encounter data, CMS would be unable to confidently use these data for risk adjustment or other program management or policy purposes.

Recommendation: The Administrator of CMS should develop a data collection strategy that ensures that states report accurate and complete data on all sources of funds used to finance the nonfederal share of Medicaid payments. There are short- and long-term possibilities for pursuing the data collection strategy, including (1) in the short-term, as part of its ongoing initiative to annually collect data on Medicaid payments made to hospitals, nursing facilities, and other institutional providers, CMS could collect accurate and complete facility-specific data on the sources of funds used to finance the nonfederal share of the Medicaid payments, and (2) in the long-term, as part of its ongoing initiative to develop an enhanced Medicaid claims data system (T-MSIS), CMS could ensure that T-MSIS will be capable of capturing information on all sources of funds used to finance the nonfederal share of Medicaid payments, and, once the system becomes operational, ensure that states report this information for supplemental Medicaid payments and other highrisk Medicaid payments.

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

Comments: The Centers for Medicare & Medicaid Services (CMS) acknowledged that it lacks adequate data on state financing methods for overseeing compliance with a certain federal requirement related to the nonfederal share and that it will examine efforts to improve data collection toward this end. In November 2019, CMS issued a proposed rule that the agency said would promote state accountability, improve federal oversight, and strengthen fiscal integrity of the Medicaid program. The proposed rule would establish new policies and codify existing policies related to reporting the sources of funds used to finance the nonfederal share of Medicaid payments. For example, the proposed rule would require states to report, at the aggregate and provider level, contributions to the state or local governments used as a source of the nonfederal share for Medicaid supplemental payments. GAO will continue to monitor the status of the proposed rule, as well as review a final rule, if one is issued, to determine the extent to which it addresses the recommendation. GAO maintains it is important that CMS and federal policymakers have more complete information about how increasing federal costs are impacting the Medicaid program, including beneficiaries and the providers who serve them and plans to continue to monitor CMS's actions to help ensure that states report accurate and complete data on all sources of the nonfederal share.

Recommendation: To assist states that rely on or are planning to contract with an MCO to administer Medicaid prescription benefits, and to help provide effective oversight of psychotropic medications prescribed to children in foster care, the Secretary of Health and Human Services should issue guidance to state Medicaid, child-welfare, and mental-health officials regarding prescription-drug monitoring and oversight for children in foster care receiving psychotropic medications through MCOs.

Agency: Department of Health and Human Services
Status: Open

Comments: In an October 2018 written response, Health and Human Services (HHS) noted that they released 2017-2018 Drug Utilization Review Summaries for Prescription Drug Fee-For-Service Programs as it relates to national statistics on state oversight of psychotropic medications, as well as new state requirements to report on their Medicaid managed care organizations. However, as of August 2019, HHS confirmed they have not issued any guidance to state Medicaid, child-welfare, and mental-health officials regarding prescription-drug monitoring and oversight for children in foster care receiving psychotropic medications through MCOs, as we recommended. We continue to believe that additional HHS guidance that helps states implement oversight strategies within the context of a managed-care environment is needed to help ensure appropriate monitoring of psychotropic medications prescribed to children in foster care.

Recommendation: To ensure that CMS and ONC can effectively monitor the effect of the EHR programs and progress made toward goals, the Secretary of Health and Human Services should direct the agencies to develop performance measures to assess outcomes of the EHR programs--including any effects on health care quality, efficiency, and patient safety and other health care reform efforts that are intended to work toward similar outcomes.

Agency: Department of Health and Human Services
Status: Open

Comments: HHS neither agreed nor disagreed with our recommendation. In July 2015, CMS noted that the agency is working to align the programs to better enable monitoring using outcome-oriented performance measures and noted that the agency is collecting data that will help them to develop such measures. CMS did not indicate when HHS plans to develop such measures as GAO recommended. In June 2016, CMS also noted that it analyzed the results of the EHR programs as of October 2015, but did not indicate that it used performance measures that assess outcomes. In September 2017, HHS officials provided us a variety of publically available reports, which they indicated show how program participants are progressing in the EHR programs and the related impacts. In 2018, CMS changed the name of these programs to the Promoting Interoperability programs to focus on improving interoperability and patients' access to health information, and officials noted that the agency is working to develop related outcome-based measures. To fully implement this recommendation, CMS needs to develop performance measures that enable the agency to assess whether the Promoting Interoperability programs are improving outcomes, such as health care quality, efficiency, and patient safety, as we recommended.

Recommendation: To ensure that CMS and ONC can effectively monitor the effect of the EHR programs and progress made toward goals, the Secretary of Health and Human Services should direct the agencies to use the information these performance measures provide to make program adjustments, as appropriate, to better achieve program goals.

Agency: Department of Health and Human Services
Status: Open

Comments: In written responses provided by HHS in February 2014, on a draft of the report, the agency indicated that it agrees that outcome-oriented performance measures will be useful to evaluating the extent that the EHR programs--enacted through legislation--achieve the expected results. However, HHS did not identify any specific actions that it might undertake to address our recommendation. In July 2015, CMS indicated that the agency is still working to develop additional performance measures, which is a necessary first step towards implementing our recommendation to HHS that CMS and ONC use the outcome-oriented performance measures to make program adjustments, as appropriate. In September 2017 and March 2018, HHS officials provided us documents, which they indicated show how information gathered through monitoring activities was used to inform the EHR programs. In November 2018, HHS officials noted that CMS is actively working to use data submitted for the Promoting Interoperability Programs to improve upon the outcomes of patients, and also indicated (as noted above) that CMS is collaborating with stakeholders to develop outcome-based measures for the Promoting Interoperability Programs. To fully implement this recommendation, CMS needs to develop outcome-oriented performance measures and then demonstrate it is using them to make appropriate program adjustments. We will update the status of this recommendation when we receive additional information.

Recommendation: To enhance its oversight of drug shortages, particularly as the agency fine-tunes the manner in which it gathers data on shortages and transitions from its database to a more robust system, the Commissioner of FDA should conduct periodic analyses using the existing drug shortages database (and, eventually, the new drug shortages information system) to routinely and systematically assess drug shortage information, and use this information proactively to identify risk factors for potential drug shortages early, thereby potentially helping FDA to recognize trends, clarify causes, and resolve problems before drugs go into short supply.

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

Comments: In September 2018, FDA told us that it was using its drug shortage data system, the "Shortage Tracker," to summarize information reported by manufacturers as the reasons for existing shortages. The agency indicated that it was developing a model that would factor in drug shortage data, warning signs identified through social media, and other factors to help identify early indicators that may predict future shortages. In July 2019, the agency indicated it could conduct periodic analyses of the causes of drug shortages. However, FDA had not yet proactively conducted any rigorous analyses of predictors of drug shortages to help recognize trends, clarify causes, and resolve problems before drugs go into short supply. In an August 2020 written response, FDA reported that it was undertaking modeling efforts to explore the feasibility of predicting future drug shortages using machine learning approaches. FDA planned to complete the initial modeling by fall 2020, at which time it would identify next steps. The agency indicated that the recommendation should remain open, and GAO will continue to monitor the implementation of this recommendation.

Recommendation: To help ensure that qualified CDRs promote improved quality and efficiency of physician care for Medicare beneficiaries, the Secretary of Health and Human Services should direct CMS to establish a requirement for qualified CDRs to demonstrate improvement on key measures of quality and efficiency for their target populations.

Agency: Department of Health and Human Services
Status: Open

Comments: As of April 2019, HHS officials reported that they were implementing new requirements for qualified CDRs, but these requirements were not related to demonstrating improvement on the measures of quality and efficiency, as GAO recommended. We will update the status of this recommendation when we receive additional information.

Recommendation: To help ensure that qualified CDRs promote improved quality and efficiency of physician care for Medicare beneficiaries, the Secretary of Health and Human Services should direct CMS to establish a process for monitoring compliance with requirements for qualified CDRs that draws on relevant expert judgment. This process should assess CDR performance on each requirement in a way that takes into account the varying circumstances of CDRs and their available opportunities to promote quality and efficiency improvement for their target populations.

Agency: Department of Health and Human Services
Status: Open

Comments: As of April 2019, 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: To help ensure that qualified CDRs promote improved quality and efficiency of physician care for Medicare beneficiaries, the Secretary of Health and Human Services should determine and implement actions to reduce barriers to the development of qualified CDRs, such as (1) developing guidance that clarifies Health Insurance Portability and Accountability Act requirements to promote participation in qualified CDRs; (2) working with private sector entities to make relevant multipayer cost data available to qualified CDRs; (3) testing one or more models of shared savings between Medicare and qualified CDRs that achieve reduced Medicare expenditures with improved quality of care, and (4) providing technical assistance to qualified CDRs.

Agency: Department of Health and Human Services
Status: Open

Comments: As of April 2019, HHS officials have not informed us of any actions taken to implement this recommendation beyond providing limited technical assistance to qualified CDRs through monthly support calls and an annual kick-off meeting. We will update the status of this recommendation when we receive additional information.

Recommendation: To help ensure that qualified CDRs promote improved quality and efficiency of physician care for Medicare beneficiaries, the Secretary of Health and Human Services should determine key data elements needed by qualified CDRs--such as those relevant for a required core set of measures--and direct Office of the National Coordinator for Health Information Technology and CMS to include these data elements, if feasible, in the requirements for certification of EHRs under the EHR incentive programs.

Agency: Department of Health and Human Services
Status: Open

Comments: As of April 2019, 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: In order to reduce the administrative costs associated with a fragmented MAI grant structure that diminishes the effective use of HHS's limited HIV/AIDS funding, and to enhance services to minority populations, HHS should consolidate disparate MAI funding streams into core HIV/AIDS funding during its budget request and allocation process.

Agency: Department of Health and Human Services
Status: Open

Comments: HHS stated that it does not support the consolidation of Minority AIDS Initiative (MAI) funds into core funding. As of January 2020, HHS had not changed its position. We will update the status of this recommendation when we receive additional information.

Recommendation: In order to reduce the administrative costs associated with a fragmented MAI grant structure that diminishes the effective use of HHS's limited HIV/AIDS funding, and to enhance services to minority populations, HHS should seek legislation to amend the Ryan White Comprehensive AIDS Resources Emergency Act of 1990 or other provisions of law, as necessary, to achieve a consolidated approach.

Agency: Department of Health and Human Services
Status: Open

Comments: HHS stated that it does not support the consolidation of Minority AIDS Initiative (MAI) funds into core funding. As of January 2020, HHS had not changed its position. We will update the status of this recommendation when we receive additional information.

Recommendation: To help address the uncertainty NIH faces, related to the potential impact of increasing indirect costs on its funding of future research, the Director of NIH should assess the impact of growth in indirect costs on its research mission, including, as necessary, planning for how to deal with potential future increases in indirect costs that could limit the amount of funding available for total research, including the direct costs of research projects.

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

Comments: As of July 7, 2015, NIH provided some information indicating that it had taken action to address our recommendation by tracking the size of indirect costs as a proportion of NIH's overall budget as part of the agency's annual budget planning process and risk assessment program. However, we determined that the actions did not fully address the recommendation because they focus on the agency's overall budget and do not assess the potential ongoing impact of indirect costs for universities on its mission. As of September 2018, NIH 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: To improve CTP's ability to operate efficiently, achieve effective results, and plan appropriately, the Secretary of Health and Human Services should direct the Commissioner of FDA to monitor FDA's performance relative to those time frames, such as evaluating whether staff are performing reviews of these submissions efficiently and effectively.

Agency: Department of Health and Human Services
Status: Open

Comments: FDA has established and monitored performance measures that include time frames for reviewing and acting on regular SE submissions, Exemption from SE requests, and Modified Risk Tobacco Product applications for fiscal years 2015 through 2018. However, we are leaving this recommendation open until FDA begins monitoring its performance relative to timeframes for provisional SE submissions, which the agency plans to do at the end of fiscal year 2019.

Recommendation: The Administrator of CMS should insert a self-referral flag on its Medicare Part B claims form, require providers to indicate whether the IMRT service for which a provider bills Medicare is self-referred, and monitor the effects that self-referral has on costs and beneficiary treatment selection.

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

Comments: In August 2013, we recommended that the Administrator of the Centers for Medicare & Medicaid Services (CMS) insert a self-referral flag on its Medicare Part B claims form, require providers to indicate whether the intensity-modulated radiation therapy (IMRT) service for which a provider bills Medicare is self-referred, and monitor the effects that self-referral has on costs and beneficiary treatment selection. The Department of Health and Human Services (HHS) did not concur with this recommendation, noting that CMS does not believe that this recommendation will address overutilization that occurs as a result of self-referral, would be complex to administer, and may have unintended consequences. We continue to believe that such a flag on Part B claims would likely be the easiest and most cost-effective way for CMS to identify self-referred IMRT services and monitor the effects of self-referral. As of June 2020, CMS has not provided any additional information about actions it has taken to address this recommendation.

Recommendation: To improve the transparency of the process for reviewing and approving spending limits for comprehensive section 1115 demonstrations, the Secretary of Health and Human Services should reconsider adjustments and costs used in setting the spending limits for the Arizona and Texas demonstrations, and make appropriate adjustments to spending limits for the remaining years of each demonstration.

Agency: Department of Health and Human Services
Status: Open

Comments: As of January 2020, the Department of Health and Human Services (HHS) has taken steps to address GAO's 2013 recommendation, but more actions are needed for GAO to consider this recommendation implemented. Beginning in May 2016, the Centers for Medicare & Medicaid Services (CMS) began implementing a new budget neutrality policy. The new policy was outlined in a Letter to State Medicaid Directors in 2018, and it addressed certain problems GAO identified regarding states' allowed methods for determining budget neutrality of their demonstrations. CMS has begun phasing in the methods established under this new policy for all states, including the two states (Arizona and Texas) for which GAO recommended adjustments. One portion of the policy--under which spending limits will be updated to reflect more recent spending data--will be implemented beginning in 2021 and will address concerns GAO identified in Arizona's spending limit once its demonstration is renewed. In January 2019, CMS officials told GAO that the agency continues to allow states to include hypothetical costs when determining demonstration spending limits, an action GAO identified as a concern in Texas' demonstration. While CMS officials provided documentation on changes the agency made in the spending limit approved for Texas' new demonstration period beginning in January 2018, GAO reviewed these changes and found that further adjustments are needed to remove additional hypothetical costs from the Texas' spending limit.

Recommendation: In order to improve CMS's ability to identify self-referred anatomic pathology services and help CMS avoid unnecessary increases in these services, the Administrator of CMS should insert a self-referral flag on Medicare Part B claim forms and require providers to indicate whether the anatomic pathology services for which the provider bills Medicare are self-referred or not.

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

Comments: In June 2013, we recommended that the Administrator of the Centers for Medicare & Medicaid Services (CMS) insert a self-referral flag on Medicare Part B claim forms and require providers to indicate whether the anatomic pathology services for which the provider bills Medicare are self-referred or not. The Department of Health and Human Services (HHS) did not concur with this recommendation, noting that CMS does not believe that this recommendation will address overutilization that occurs as a result of self-referral. Although CMS has taken initial steps relevant to self-referral, the steps do not require a provider to indicate whether anatomic pathology services billed to Medicare are self-referred or not. Specifically, CMS has noted that Section 6409(a) of the Patient Protection and Affordable Care Act required the Secretary of the Department of Health and Human Services, in cooperation with the Inspector General of the Department of Health and Human Services, to establish a Medicare self-referral disclosure protocol that sets forth a process to enable providers of services and suppliers to self-disclose actual or potential violations of the physician self-referral statute. However, the protocol is voluntary and specific to actual or potential violations regarding self-referral, which is not relevant to our recommendation. As of January 2020, CMS has not provided any additional information about actions it has taken to address our recommendation. We continue to believe that inserting a flag on Part B claims to indicate whether an anatomic pathology service is self-referred would improve CMS's ability to monitor self-referred services, which in turn may help them take action to avoid unnecessary increases in these services.

Recommendation: In order to improve CMS's ability to identify self-referred anatomic pathology services and help CMS avoid unnecessary increases in these services, the Administrator of CMS should determine and implement an approach to ensure the appropriateness of biopsy procedures performed by self-referring providers.

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

Comments: In June 2013, we recommended that the Administrator of the Centers for Medicare & Medicaid Services (CMS) implement an approach to ensure the appropriateness of biopsy procedures performed by self-referring providers. The Department of Health and Human Services (HHS) did not concur with this recommendation and does not believe it would address overutilization that occurs as a result of self-referral. In November 2017, CMS officials noted that the agency does not have the ability to identify self-referred anatomic pathology services during medical reviews. As of January 2020, CMS has not provided any additional information about actions it has taken to address the recommendation. We continue to believe that it is important for CMS to monitor the self-referral of anatomic pathology services on an ongoing basis and determine if those services are inappropriate or unnecessary.

Recommendation: In order to improve CMS's ability to identify self-referred anatomic pathology services and help CMS avoid unnecessary increases in these services, the Administrator of CMS should develop and implement a payment approach for anatomic pathology services that would limit the financial incentives associated with referring a higher number of specimens--or anatomic pathology services--per biopsy procedure.

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

Comments: In June 2013, we recommended that the Administrator of the Centers for Medicare & Medicaid Services (CMS) develop and implement a payment approach for anatomic pathology services under the Physician Fee Schedule that would limit the financial incentives associated with referring a higher number of specimens--anatomic pathology services--per biopsy procedure. Although health care providers have discretion in determining the number of tissue samples from biopsy procedures that become specimens (anatomic pathology services), CMS's current payment system under the Physician Fee Schedule provides a financial incentive for providers to refer more specimens per biopsy procedure. Specifically, CMS pays for each specimen that a provider submits to be analyzed. HHS indicated that it concurred with our recommendation and that it had addressed this recommendation by reducing payment for the most commonly furnished anatomic pathology service (Current Procedural Terminology [CPT] code 88305) by approximately 30 percent in calendar year 2013. However, CMS's payment reduction did not change the financial incentive providers have to refer more specimens per biopsy procedure because they will still be paid separately for each specimen submitted. As of January 2020, CMS has not provided any additional information about actions it has taken to limit the financial incentives associated with referring a higher number of specimens. We continue to believe that CMS should develop a payment approach that addresses this incentive.

Recommendation: To help ensure that ADI suppliers provide consistent, safe, and high-quality imaging to Medicare beneficiaries, the Administrator of CMS should determine the content of and publish minimum national standards for the accreditation of ADI suppliers, which could include specific qualifications for supplier personnel and requiring accrediting organization review of clinical images.

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

Comments: In June 2019, HHS officials informed us that they plan to implement this recommendation in March 2020. We will update the status of this recommendation when we receive additional information.

Recommendation: To help ensure that ADI suppliers provide consistent, safe, and high-quality imaging to Medicare beneficiaries, the Administrator of CMS should develop an oversight framework for evaluating accrediting organization performance, which could include collecting and analyzing information on accreditation results and conducting validation audits.

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

Comments: In June 2019, HHS officials informed us that they plan to implement this recommendation in March 2020. We will update the status of this recommendation when we receive additional information.

Recommendation: To help ensure that ADI suppliers provide consistent, safe, and high-quality imaging to Medicare beneficiaries, the Administrator of CMS should develop more specific requirements for accrediting organization mid-cycle audit procedures and clarify guidance on immediate-jeopardy deficiencies to ensure consistent identification and timely correction of serious care problems for the duration of accreditation.

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

Comments: In June 2019, HHS officials informed us that they plan to implement this recommendation in March 2020. We will update the status of this recommendation when we receive additional information.

Recommendation: To help ensure that HHS is adequately and comprehensively assessing HPP and PHEP awardees' performance and progress in meeting the medical and public health preparedness goals of the cooperative agreements, the Secretary of Health and Human Services should direct ASPR and CDC to develop objective and quantifiable performance targets and incremental milestones that correspond to the new HPP and PHEP performance measures, against which HHS can gauge progress toward the medical and public health preparedness goals of the cooperative agreements and direct technical assistance, as needed.

Agency: Department of Health and Human Services
Status: Open

Comments: Since we examined the HPP and PHEP cooperative agreements in 2012, ASPR had developed few targets for the HPP program measures or their corresponding indicators that were contained in the HPP performance measurement guidance documents issued for Budget Periods (BP) 2-5, ending June 30, 2017. Additionally, the new HPP performance measure implementation guidance for the 5-year project cycle from 2017-2022 introduces 28 performance measures, with few having targets; the guidance notes that corresponding goals or targets may be set at a later date after data from the first budget period of this new project cycle has been reviewed. Regarding PHEP, CDC had developed performance targets for about half of the performance measures as of the PHEP BP5 performance measurement guidance (BP5 ended June 30, 2017). These performance measures generally remain the same, with existing targets, for BP1 (July 1, 2017-June 30, 2018) of the new 5-year budget cycle. GAO recognizes that it may not be appropriate to develop performance targets for every performance measure depending on the desired process or outcome; however, both agencies still have work to do in this area. In November 2017, both ASPR and CDC officials noted that they could not commit to setting consistent targets with incremental milestones over a budget cycle and therefore could not implement the recommendation. As of August 2018, there was no change from the agencies' position that they do not have plans to fully implement the recommendation at this time.

Recommendation: To help ensure that HHS is adequately and comprehensively assessing HPP and PHEP awardees' performance and progress in meeting the medical and public health preparedness goals of the cooperative agreements, the Secretary of Health and Human Services should ensure that performance measures and targets remain consistent across the 5-year project cycle and that any future measures be comparable to determine whether awardees are making progress toward meeting short- and long-term medical and public health preparedness goals of the cooperative agreements.

Agency: Department of Health and Human Services
Status: Open

Comments: Since we first examined the HPP and PHEP cooperative agreements in 2012, ASPR and CDC had made efforts to maintain consistency in their performance measures, particularly in the last 3 years of the prior project cycle which ended June 30, 2017. However, because part of the recommendation includes consistency of performance measures into future project cycles, we also examined whether both cooperative agreements continued to use basically the same performance measures into the current 5-year cycle, which began July 1, 2017. ASPR's HPP has made a significant change in its performance measures, introducing a new set of 28 performance measures for this new 5-year cycle. CDC's PHEP performance measures generally remained consistent in the last two budget periods of the prior 5-year cycle, and remained generally the same for the first year of the new 5-year cycle (some measures were "retired," though key components from a measure may continue to be used by CDC in other types of reviews). Additionally, in November 2017, both CDC and ASPR officials noted that they may need to continue to adjust the performance measures during the new 5-year cycle. As of August 2018, as a result of the change to HPP's measures and the agency statements in November 2017, GAO anticipates keeping this recommendation open at least for the next few budget periods, in order to determine whether the agencies maintain consistency with the performance measures during the new project cycle.

Recommendation: To reduce the incentive for facilities to restrict their service provision to avoid reaching the LVPA treatment threshold, the Administrator of CMS should consider revisions such as changing the LVPA to a tiered adjustment.

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

Comments: As of February 2020, CMS had not implemented this recommendation. CMS stated in February 2020 that the agency had extensive discussions with the Medicare Payment Advisory Commission regarding the Commission's suggestions for modifying the LVPA. CMS also stated that the agency was analyzing the design of the LVPA as part of its evaluation of the ESRD Prospective Payment System. This recommendation remains open because CMS has not provided documentation of steps such as those described above that the agency has taken to consider revisions to the LVPA. We will update the status of this recommendation upon receipt of additional information from CMS.

Recommendation: In order to improve CMS's ability to identify self-referred advanced imaging services and help CMS address the increases in these services, the Administrator of CMS should insert a self-referral flag on its Medicare Part B claims form and require providers to indicate whether the advanced imaging services for which a provider bills Medicare are self-referred or not.

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

Comments: HHS did not concur with this recommendation. CMS believes that a new checkbox on the claim form identifying self-referral would be complex to administer and providers may not characterize referrals accurately. We continue to believe that such a flag on Part B claims would likely be the easiest and most cost-effective way for CMS to identify self-referred advanced imaging services and monitor the behavior of those providers who self-refer these services, even though the agency has no plans to take further action. As of January 2020, CMS continues to indicate it will not take additional actions to address this recommendation.

Recommendation: In order to improve CMS's ability to identify self-referred advanced imaging services and help CMS address the increases in these services, the Administrator of CMS should determine and implement a payment reduction for self-referred advanced imaging services to recognize efficiencies when the same provider refers and performs a service.

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

Comments: HHS did not concur with this recommendation, noting that CMS did not believe that a payment reduction would address overutilization that occurs as a result of self-referral and that the agency's multiple procedure payment reduction policy for advanced imaging already captures efficiencies inherent in providing multiple advanced imaging services by the same physician. Further, CMS does not think a payment reduction for self-referred services would be effective. For example, the agency believes that providers in self-referring arrangements could avoid this reduction by having one provider refer an advanced imaging service while having another perform the service. Finally, CMS questioned whether implementing our recommendation would violate the Medicare statute prohibiting paying a differential by physician specialty for the same service. Our recommendation, however, refers to specific self-referral arrangements in which the same provider refers and performs an imaging service, and therefore would not be addressed by CMS's multiple procedure payment reduction policy. As noted in our report, this payment reduction would affect about 10 percent of advanced imaging services referred by self-referring providers. In addition, while CMS raised questions about whether implementing our recommendation would violate Medicare's prohibition on paying a differential by physician specialty for the same service, our report shows that self-referring providers generally referred more MRI and CT services, regardless of differences in specialties, and CMS did not indicate how this recommendation would implicate the prohibition on paying a differential by specialty. We continue to believe that CMS should determine and implement a payment reduction to recognize efficiencies for advanced imaging services referred and performed by the same provider. As of January 2020, the agency has no plans to take further action regarding this recommendation.

Recommendation: In order to improve CMS's ability to identify self-referred advanced imaging services and help CMS address the increases in these services, the Administrator of CMS should determine and implement an approach to ensure the appropriateness of advanced imaging services referred by self-referring providers.

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

Comments: HHS did not concur with this recommendation, according to its fiscal year 2021 budget justification. To fully implement this recommendation, CMS should determine and implement an approach to ensure the appropriateness of advanced imaging services referred by self-referring providers.

Recommendation: To enhance federal agencies' ability to realize enterprise architecture benefits, the Secretaries of the Departments of Health and Human Services and Housing and Urban Development should ensure that enterprise architecture outcomes are periodically measured and reported to top agency officials.

Agency: Department of Health and Human Services
Status: Open

Comments: As of January 2020, the Department of Health and Human Services had not implemented this recommendation. Specifically, it had not demonstrated that it had measured architecture metrics that it had established in its April 2014 Enterprise Roadmap. We will continue to monitor the department's efforts to implement the recommendation.

Recommendation: To help ensure the success of FDA's modernization efforts, the Commissioner of FDA should direct the CIO to, in completing the assessment of Mission Accomplishments and Regulatory Compliance Services (MARCS), develop an integrated master schedule (IMS) that (1) identifies which legacy systems will be replaced and when; (2) identifies all current and future tasks to be performed by contractors and FDA; and (3) defines and incorporates information reflecting resources and critical dependencies.

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

Comments: In 2018, we confirmed that FDA, in response to our recommendation, began efforts to identify which legacy systems will be replaced. FDA also developed an IMS for fiscal year (FY) 2017 and 2018 that identifies current and future tasks to be performed by contractors and FDA. However, FDA's IMS for FY 2017 and 2018 does not fully and clearly define resources. For example, although the FY 2017 IMS includes 265 names, roles, and teams, only 16 percent of activities have resource assignments. Further, FDA's fiscal year 2018 IMS does not fully define critical dependencies. For example, there are 14 activities and milestones with finish dates that are not properly tied to logic. Specifically, the finish dates of the 14 activities are not clearly tied to succeeding activities in the schedule. We contacted FDA in September and December 2019 and January 2020 for an update on the actions taken to implement the recommendation, but have not received a response. We will update the recommendation when additional information is obtained.

Recommendation: To improve the effectiveness of the MSP program and process for NGHPs, and to improve the agency's communication regarding the MSP process for situations involving NGHPs, the Acting Administrator of CMS should develop guidance regarding liability and no-fault set-aside arrangements.

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

Comments: As of March 2019, CMS officials reported that the agency was still in the process of implementing this recommendation about developing guidance regarding liability and no-fault set-aside arrangements. Since April 2012, the month the recommendation was made, CMS officials have reported at various times that the agency was planning to issue either regulatory or sub-regulatory guidance on this topic. In March 2019, officials said that the agency now planned to issue regulatory guidance, and that a Notice of Proposed Rulemaking was expected to be posted in October 2019. We will continue to update the status of this recommendation as new information is available.