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 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: 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 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 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 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, 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 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 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 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: 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: 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 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 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 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 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 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 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 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 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 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: 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 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: 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: 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 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 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 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 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: 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: 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: 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 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 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 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 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 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 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 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 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: 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: 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 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: As HHS implements its current and forthcoming efforts to make transparent price information available to consumers, HHS should determine the feasibility of making estimates of complete costs of health care services available to consumers through any of these efforts.

Agency: Department of Health and Human Services
Status: Open

Comments: In May 2013, CMS released average inpatient hospital charge information for more than 3,000 hospitals that receive Medicare Inpatient Prospective Payment System payments for the 100 most frequently billed discharges using DRGs from FY2011 and corresponding average Medicare payments. Shortly thereafter CMS also released outpatient charges. In April 2014, CMS also released data on payments to physicians under Medicare part B. This represents an effort to provide price transparency, although these are not complete cost estimates according to our definition in this report. As of September 2015, we are awaiting an update from HHS on the status of this recommendation. We will update the status of this recommendation when we receive additional information.

Recommendation: As HHS implements its current and forthcoming efforts to make transparent price information available to consumers, HHS should determine, as appropriate, the next steps for making estimates of complete costs of health care services available to consumers.

Agency: Department of Health and Human Services
Status: Open

Comments: As of September 2015, we are awaiting an update from HHS on the status of this recommendation. We will update the status of this recommendation when we receive additional information.

Recommendation: PPACA contained several important program integrity provisions for the 340B program, and additional steps can also ensure appropriate use of the program. Therefore, the Secretary of HHS should instruct the administrator of HRSA to finalize new, more specific guidance on the definition of a 340B patient.

Agency: Department of Health and Human Services
Status: Open

Comments: In January 2017, HRSA withdrew proposed guidance that included further specificity on the definition of 340B patient in response to the new administration's January 20 memorandum directing agencies to withdraw regulations that were pending before the Office of Management and Budget but had not yet been published in the Federal Register. In March 2018, HRSA told GAO that it continues to assess next steps with the Administration on the proposed omnibus guidance, which included the patient definition. In June 2019, HRSA reported that it is still working with the Department to determine next steps for this recommendation. In July 2020, HRSA reported that it conducted an evaluation of its audit process and other program integrity efforts and determined that guidance does not provide the agency with appropriate enforcement capability. Therefore, HRSA is not pursing new guidance under the Program at this time. The FY 2021 President's Budget includes a proposal to provide HRSA comprehensive regulatory authority.

Recommendation: PPACA contained several important program integrity provisions for the 340B program, and additional steps can also ensure appropriate use of the program. Therefore, the Secretary of HHS should instruct the administrator of HRSA to issue guidance to further specify the criteria that hospitals that are not publicly owned or operated must meet to be eligible for the 340B program.

Agency: Department of Health and Human Services
Status: Open

Comments: In January 2017, HRSA withdrew proposed guidance that included additional specificity regarding hospital eligibility in response to the new administration's January 20 memorandum directing agencies to withdraw regulations that were pending before the Office of Management and Budget but had not yet been published in the Federal Register. In March 2018, HRSA reported that it believes it is unable to implement this recommendation without additional legislative authority because the statute does not speak to the issue raised in the recommendation. HRSA also noted that the FY19 President's Budget includes a proposal to provide HRSA comprehensive regulatory authority, and that if this proposal is enacted, it could regulate on hospital eligibility. In June 2019, HRSA reported that it is still unable to implement this recommendation without additional legislative authority, though the President's FY 2020 Budget includes a proposal to provide HRSA with such authority. In July 2020, HRSA reported that it conducted an evaluation of its audit process and other program integrity efforts and determined that guidance does not provide the agency with appropriate enforcement capability. Therefore, HRSA is not pursing new guidance under the Program at this time. The FY 2021 President's Budget includes a proposal to provide HRSA comprehensive regulatory authority.

Recommendation: To enhance the provision of dental care to children covered by Medicaid and CHIP, and to help ensure that HHS's Insure Kids Now Web site is a useful tool to help connect children covered by Medicaid and CHIP with participating dentists who will treat them, the Secretary of HHS should require states to verify that dentists listed on the Insure Kids Now Web site have not been excluded from Medicaid and CHIP by the HHS-OIG, and periodically verify that excluded providers are not included on the lists posted by the states.

Agency: Department of Health and Human Services
Status: Open

Comments: As of September 2020, CMS has not indicated taking steps to require states to ensure excluded providers are not listed on the Insure Kids Now website, nor has it indicated taking steps to periodically verify that providers excluded from Medicaid and CHIP are not on the list. CMS has said that it relies on states to provide accurate lists of eligible dentists and that data issues prevent the agency from independently verifying that excluded providers are not included on the Insure Kids Now website. We continue to believe that CMS should require states to ensure that excluded providers are not listed on the website and periodically verify that excluded providers are not included on the lists posted by the states, so that the website does not present inaccurate information about providers available to serve Medicaid-covered children.

Recommendation: To better account for physicians practicing in underserved areas through the use of J-1 visa waivers, the Secretary of Health and Human Services should collect and maintain data on waiver physicians--including information on their numbers, practice locations, and practice specialties--and use this information when identifying areas experiencing physician shortages and placing physicians in these areas.

Agency: Department of Health and Human Services
Status: Open

Comments: HHS concurred with our recommendation, commenting that the department's goal was to assure that the limited resources of the J-1 visa waiver program and other programs addressing areas and populations with limited access to health care professionals are targeted most effectively. In 2013, HHS indicated that it was considering the best approach to collect information to identify J-1 visa physicians practicing in underserved areas. As of February 2018, however, HHS reported that it does not have the capacity to track physicians practicing in underserved areas through the use of J-1 visa waivers, citing reasons such as the number of federal entities and states involved in the process. While we recognize that collecting and maintaining these data requires coordination with other agencies, we continue to believe that without data on waiver physicians, HHS--the federal agency with primary responsibility for addressing physician shortages--will lack the information needed to consider waiver physicians working in underserved areas when placing providers in these areas under other programs. As of August 2019, HHS officials have not informed us of actions taken to implement this recommendation. We are leaving this recommendation open until the department collects and maintains data on waiver physicians and considers those physicians in its efforts to address physician shortages.

Recommendation: To meet its fiduciary responsibility of ensuring that section 1115 waivers are budget neutral, the Secretary of Health and Human services should better ensure that valid methods are used to demonstrate budget neutrality, by developing and implementing consistent criteria for consideration of section 1115 demonstration waiver proposals.

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

Comments: As of January 2020, the Department of Health and Human Services (HHS) had taken some action to address GAO's 2002 recommendation. In August 2018, HHS issued written guidance through a State Medicaid Directors Letter documenting four key changes it made in 2016 to its budget neutrality policy. These changes addressed some, but not all of the questionable methods GAO identified in its reports. To fully address this recommendation, HHS should also address these other questionable methods, such as setting demonstration spending limits based on hypothetical costs-what the state could have paid-rather than payments actually made by the state. GAO has found that the use of hypothetical costs has the potential to inflate spending limits and thus threatens budget neutrality of demonstrations