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    Federal Agency: "Department of Health and Human Services"

    195 publications with a total of 393 open recommendations including 47 priority recommendations
    Director: Katherine M. Iritani
    Phone: (202) 512-7114

    1 open recommendations
    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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Timothy J. DiNapoli
    Phone: (202) 512-4841

    1 open 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: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Steve Morris
    Phone: (202) 512-3841

    2 open recommendations
    Recommendation: The Commissioner of FDA should pursue formal agreements with countries exporting seafood to the United States that commit these countries to test for drugs of concern to FDA and the corresponding maximum residue levels (MRLs) that FDA established for these drugs. (Recommendation 1)

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Commissioner of FDA should coordinate and communicate with FSIS in developing drug residue testing methods and corresponding maximum residue levels for imported seafood that may also be applicable to imported catfish. (Recommendation 4)

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Valerie C. Melvin
    Phone: (202) 512-6304

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: David A. Powner
    Phone: (202) 512-9286

    6 open recommendations
    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: 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 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: 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 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: 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 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: 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 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: 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 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: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: David A. Powner
    Phone: (202) 512-9286

    1 open recommendations
    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: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Katherine Iritani
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To improve CMS's oversight of states' MLTSS programs, the Administrator of CMS should take steps to identify and obtain key information needed to oversee states' efforts to monitor beneficiary access to quality services, including, at a minimum, obtaining information specific to network adequacy, critical incidents, and appeals and grievances.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Debra A. Draper
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: To help ensure that the WTC Health Program quality assurance (QA) program addresses required QA elements, including the three elements mandated in the Zadroga Act, the Director of NIOSH should develop and implement procedures for conducting systematic reviews of each clinic's QA plan (recommendation 1).

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To help ensure that the WTC Health Program QA program addresses required QA elements, including the three elements mandated in the Zadroga Act, the Director of NIOSH should develop and disseminate guidance that clearly specifies how the clinics should address mandated elements in their QA plans (recommendation 2).

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To help ensure that the WTC Health Program QA program addresses required QA elements, including the three elements mandated in the Zadroga Act, the Director of NIOSH should develop uniform performance measures that clinics are required to use to consistently evaluate mandated elements through their audits every quarter (recommendation 3).

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Kathleen M. King
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: The Administrator of CMS should evaluate the possible costs and savings of using disposable devices that could potentially substitute for DME, including options for benefit categories and payment methodologies that could be used to cover these substitutes, and, if appropriate, seek legislative authority to cover these devices.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Beryl H. Davis
    Phone: (202) 512-2623

    10 open recommendations
    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

    Comments: HHS concurred with this recommendation. HHS stated that in FY 2016, it completed a risk assessment of the advance PTC program and reported results in the FY 2016 Agency Financial Report. Currently, HHS is unable to specify the year the rate and amount will be reported due to the complexity and timing of the error rate measurement methodology process, which involves conducting pilot testing, using those pilots to refine the methodology, and then undergoing the rulemaking process before implementing the methodology to ensure accurate and efficient reporting of an improper payment rate.
    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. HHS stated that it reported information on the status of the advance PTC risk assessment in the FY 2014 to FY 2016 Agency Financial Reports. Now that the program's improper payment risk assessment is completed, HHS will continue to report on its progress in designing and implementing an improper payment estimate for the advance PTC program in future Agency Financial Reports.
    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: HHS neither agreed nor disagreed with this recommendation. However, regarding verification of filer identity, HHS stated that for individuals starting a new application via phone, the call center representatives use verbal attestations for identity 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. GAO continues to believe that because CMS does not validate the identities of individuals who apply by phone or mail, CMS is vulnerable to enrolling ineligible individuals in qualified health plans with advance PTC.
    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 assess and document the feasibility and availability of obtaining sufficiently reliable data to verify individuals' residencies and lack of minimum essential coverage from nonfederal employers and, if appropriate, design and implement procedures for using such data in its verification processes.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS concurred with this recommendation. HHS stated that its previous assessments of available electronic data sources did not identify any comprehensive national data source for verifying residency. HHS recently conducted a study to assess the feasibility of developing an employer-sponsored coverage database and determined that development would be costly and highly burdensome given available resources. Additionally, HHS stated that it would impose extra burden on employers to collect the information needed to build a comprehensive employer-sponsored coverage database. HHS will continue to assess and document whether any sufficiently reliable data sources exist and examine the feasibility of implementation.
    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 sending notices to nonfederal employers routinely and terminating advance PTC for individuals who have access to minimum essential coverage from their employers.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS neither agreed nor disagreed with this recommendation. However, regarding sending notices to nonfederal employers, HHS stated that it is evaluating its 2016 employer notice program to determine the best approach for notifying employers in the future. Such an evaluation may provide useful information; however, GAO continues to believe that designing and implementing procedures for sending notices to nonfederal employers and terminating advance PTC to individuals with access to employer-sponsored coverage can reduce the risk of providing advance PTC to issuers on behalf of ineligible individuals.
    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 assess and document the feasibility of approaches for (1) identifying duplicate government-sponsored coverage for individuals receiving Medicaid and Children's Health Insurance Program coverage in federally facilitated marketplace states outside of the states where they attest to residing and (2) periodically verifying individuals' continued eligibility by working with other government agencies to identify changes in life circumstances that affect advance PTC9 eligibility--such as commencement of duplicate coverage or deaths-- that may occur during the plan year and, if appropriate, design and implement these verification processes.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS concurred with this recommendation. HHS stated that its preliminary analysis indicates that identifying government sponsored coverage for individuals receiving Medicaid and CHIP in Federally-facilitated Exchange states outside of the state where the applicant is enrolled in coverage would add several months to the time needed to execute the process of identifying duplicate enrollees and ending their advance PTC. Such additional time would significantly reduce the timeliness and effectiveness of the process and lead to an increase in burden on the state Medicaid systems used to verify duplicate coverage. HHS stated that it will continue this analysis and document the feasibility of approaches for identifying duplicate government sponsored coverage for individuals receiving Medicaid and CHIP coverage in Federally-facilitated Exchange states outside the application state of the consumer as well as periodically verifying individual's continued eligibility. In addition, HHS stated that it has implemented a Periodic Data Matching process to proactively identify consumers who may be receiving Minimum Essential Coverage through Medicare, and thus are no longer eligible for financial assistance to help pay for Exchange coverage. HHS is also exploring approaches to identifying Exchange enrollees who may be deceased and should thus be disenrolled from coverage.
    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 assess and document the feasibility of approaches for terminating advance PTC on a timelier basis and, as appropriate, design and implement procedures for improving the timeliness of terminations.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS concurred with this recommendation. HHS stated that it continues to assess the feasibility of terminating advance PTC at various times of the month as a result of consumers not resolving inconsistencies. HHS currently terminates advance PTC between the 1st and 15th of the month following the end of the inconsistency clock in order to accommodate issuer processes. HHS stated that processing in these cohorts also allows for operational and quality efficiencies for HHS since processes can be completed in batches.
    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 compliance with applicable tax filing requirements--including the filing of the federal tax return and the Form 8962, Premium Tax Credit--necessary for individuals to continue to be eligible for advance PTC.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS concurred with this recommendation. HHS stated that the IRS provides information to Exchanges on consumers who received advance PTC in the prior coverage year but have not taken the necessary steps to file a tax return and reconcile advance PTC. Beginning in Open Enrollment for 2018, the Federally-facilitated Exchange will end advance PTC on behalf of the tax filers who have not filed or have not reconciled advance PTC when that information is reported to the Exchange by IRS.
    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 major life changes using documentation submitted by applicants enrolling during special enrollment periods.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS concurred with this recommendation. HHS stated that it is continually monitoring the operations of the Exchange and has taken several steps to analyze and strengthen current rules and procedures to ensure that only those who are eligible enroll through special enrollment periods. While special enrollment periods provide a criticial pathway to coverage for qualified individuals who experience qualifying events, it's equally important that special enrollment periods are not misused or abused. HHS also stated that in April 2017, it issued a final rule on Market Stabilization that promotes program integrity by requiring individuals to submit supporting documentation for special enrollment periods and ensures that only those who are eligible are able to enroll. It will encourage individuals to stay enrolled in coverage all year, reducing gaps in coverage and resulting in fewer individual mandate penalties and help to lower premiums. This process will begin in June 2017.
    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 with IRS (1) household incomes, when attested income amounts significantly exceed income amounts reported by IRS or other third-party sources, and (2) family sizes.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS neither agreed nor disagreed with this recommendation. However, regarding verification of household income and family sizes, HHS stated that as part of its eligibility verification requirements, it verifies consumer-reported income with data from IRS. However, HHS stated that because household incomes may fluctuate year to year, it is difficult for consumers to project income for the year in advance. According to HHS, in instances where applicant-reported income is higher than the IRS data, HHS accepts the consumer attestation. However, HHS stated that it will assess the feasibility and burden on individuals of setting a reasonable threshold for the generation of annual household income inconsistencies that would require additional verification for consumer-attested income that significantly exceeds income amounts reported by IRS or other third party sources. We believe that such an evaluation is a reasonable step to address our recommendation to enhance the effectiveness and efficiency of the program related to verification of household income. In addition, HHS stated that it currently accepts attestation when the family size provided by the individual does not match IRS's records. HHS stated that establishing a process to verify family size with IRS would require significant operational and privacy complexity. While we recognize that there may be certain complexities in the verification of family sizes, it is important that CMS develop policies and procedures to reasonably assure that such verifications are made on a regular basis.
    Director: John Dicken
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To help FDA meet its goal of facilitating expanded access to investigational drugs by patients with serious or life-threatening diseases or conditions, when appropriate, the Commissioner of FDA should clearly communicate how the agency will use adverse event data from expanded access use when reviewing drugs and biologics for approval for marketing and sale in the United States.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: James Cosgrove
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: To ensure that the HVBP program accomplishes its goal to balance quality and efficiency and to ensure that it minimizes the payment of bonuses to hospitals with lower quality scores, the Administrator of CMS should revise the formula for the calculation of hospitals' total performance score or take other actions so that the efficiency score does not have a disproportionate effect on the total performance score.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To ensure that the HVBP program accomplishes its goal to balance quality and efficiency and to ensure that it minimizes the payment of bonuses to hospitals with lower quality scores, the Administrator of CMS should revise the practice of proportional redistribution used to correct for missing domain scores so that it no longer facilitates the awarding of bonuses to hospitals with lower quality scores.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Dicken, John E
    Phone: (202)512-7114

    1 open recommendations
    Recommendation: To ensure efficient use of generic drug user fees, facilitate oversight and transparency, and plan for risks, the Commissioner of FDA should develop a plan for administering user fee carryover that includes analyses of program costs and risks and reflects actual operational needs and contingencies.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Persons, Timothy M
    Phone: (202) 512-6412

    5 open recommendations
    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of the Food and Drug Administration to consolidate information from individual diagnostic test labels and make this information available in a form that enables users to more readily compare information across tests.

    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 is working to consolidate and make available on its website information for Zika virus diagnostic tests that have emergency use authorization.
    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.
    Recommendation: The Secretary of Health and Human Services should direct the Director of Centers for Disease Control and Prevention to establish a transparent process to provide CDC diagnostic tests, upon request, to manufacturers that are in the final stages of diagnostic test authorization.

    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 Centers for Disease Control and Prevention (CDC) Technology Transfer Office is working to establish a transparent process that ensures CDC diagnostic tests can be provided to manufacturers.
    Recommendation: The Secretary of Health and Human Services should direct the Director of Centers for Disease Control and Prevention to include information on CDC-developed tests distributed to or shared with public health laboratories on CDC's website, including laboratory developed tests.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2017, officials from the Department of Health and Human Services told us the Centers for Disease Control and Prevention (CDC) provides information on CDC-developed diagnostic tests on the Food and Drug Administration?s (FDA) website. CDC stated that their website will feature a direct link to FDA information on CDC-developed tests. CDC will continue to explore additional outlets for publication of information on CDC-developed diagnostic tests.
    Recommendation: The Secretary of Health and Human Services should direct the Director of Centers for Disease Control and Prevention to provide details such as collection records, dates, and data limitations on posted and disseminated mosquito distribution maps to better inform mosquito control experts and the general public.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In June 2016, the Centers for Disease Control and Prevention (CDC) published a report on the distribution of the mosquitos that can transmit Zika virus and other viruses in the United States. This report included new county collection records, collection dates, and summary maps for each species of mosquitos. In August 2017, officials from the Department of Health and Human Services told us the CDC is planning to update the mosquito distribution information on their website by the end of 2017, and it will include the underlying model predictions and country collection records.
    Director: David Powner
    Phone: (202) 512-9286

    2 open recommendations
    Recommendation: The following 17 agencies (the Secretaries of the Departments of Commerce, Defense, Energy, Health and Human Services, Interior, Labor, State, Transportation, Treasury, and Veterans Affairs; the Attorney General; and the Administrators of the Environmental Protection Agency, National Aeronautics and Space Administration, Small Business Administration, and U.S. Agency for International Development; the Chairman of the Nuclear Regulatory Commission; and the Commissioner of the Social Security Administration) should each take action to complete the missing elements in their respective DCOI strategic plan, including addressing any identified challenges, and submit their completed strategic plan to OMB.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: The Department of Health and Human Services has not yet taken action to implement our recommendation. We will continue to monitor the department's efforts to address the recommendation.
    Recommendation: Finally, the following 11 agencies (the Secretaries of the Departments of Commerce, Education, Health and Human Services, Interior, Labor, State, Transportation, and Treasury; the Administrators of the Environmental Protection Agency, General Services Administration, and the U.S. Agency for International Development) should also each take action to ensure that the amounts of achieved data center cost savings and avoidances are consistent across all reporting mechanisms, including the quarterly data submissions and DCOI strategic plans.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: The Department of Health and Human Services has not yet taken action to implement our recommendation. We will continue to monitor the department's efforts to address the recommendation.
    Director: Marie Mak
    Phone: (202) 512-4841

    2 open recommendations
    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.
    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.
    Director: Seto Bagdoyan
    Phone: (202) 512-6722

    1 open recommendations
    Recommendation: To enhance consumer understanding of agency oversight roles and to strengthen agency oversight of Internet marketing, the Secretary of the Department of Health and Human Services and the Chair of the FTC should develop and provide additional guidance to consumers delineating the agencies' differing roles in their shared oversight of memory supplement and other dietary supplement marketing on the Internet.

    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.
    Director: Jacqueline M. Nowicki
    Phone: (617) 788-0580

    2 open recommendations
    Recommendation: To improve collaboration and leverage the knowledge of key federal agencies serving youth with ASD, the Secretary of HHS should regularly engage key non-member federal agencies that serve or provide supports to young adults with autism in IACC activities. This could include, for example, directly engaging and soliciting input from federal agencies on the IACC strategic plan, or inviting other federal agencies that serve or provide supports to young adults with autism to become IACC members.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In 2017, HHS stated that it has engaged with federal agencies as part of an interagency working group on the needs of youth and young adults with Autism Spectrum Disorder. Our report stated that the IACC missed opportunities to collaborate with non-member federal agencies to report on and monitor services and supports activities for individuals with ASD, which Congress has called for IACC to include in its annual strategic plan and monitoring activities. In response, HHS stated that it has engaged several nonmember federal agencies at various points. However, we continue to believe it should develop strategies to regularly engage key non-member federal agencies in IACC activities, such as by soliciting input on its annual strategic plan.
    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: HHS agreed with this recommendation but stated that the voluntary nature of the FPT precludes definitive implementation plans. We maintain, however, that being a voluntary initiative does not preclude the FPT from establishing long-term milestones and clarifying roles and responsibilities. Without a long-term implementation plan that includes milestones and specific agency roles and assignments, it is less likely that the priorities outlined in the Federal Youth Transition Plan will be achieved.
    Director: James Cosgrove
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To strengthen CMS's oversight of MA contracts, the Administrator of CMS should review data on disenrollment by health status and the reasons beneficiaries disenroll as part of the agency's routine monitoring efforts.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: John Neumann
    Phone: (202) 512-3841

    1 open recommendations
    Recommendation: To help improve the implementation of the fraud, waste, and abuse prevention requirements, the Secretary of Health and Human Services (HHS) should direct the HHS SBIR and STTR program offices to collect copies of the self-certification forms from its SBIR and STTR awardees.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In its comments on a draft of the report, HHS did not concur with our recommendation. In its June 2017 letter on plans for implementing the recommendation, HHS stated that the National Institutes of Health will collect life cycle certifications from SBIR and STTR program recipients through its electronic reporting system, which will allow other HHS components that use that system to also collect the forms. The National Institutes of Health plans to begin collecting the life cycle certification forms in fiscal year 2018. We will review the actions to address this recommendation once they are complete.
    Director: Katherine Iritani
    Phone: (202) 512-7114

    2 open recommendations
    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: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    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 issue formal guidance on the revised budget neutrality policy, including information on how the policy will be applied.

    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.
    Director: Carolyn L. Yocom
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: To build upon CMS's collaborative audit efforts and help enhance future collaboration, CMS should identify opportunities to address barriers that limit states' participation in collaborative audits. Such opportunities could include improving communication with states before, during, and after audits are completed; and ensuring that audits align with states' program integrity needs, including the need for oversight of services provided in managed care delivery systems.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To better support states' efforts to reduce improper payments and communicate effective program integrity practices across the states, CMS should collaborate with states to develop a systematic approach to collect promising state program integrity practices.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To better support states' efforts to reduce improper payments and communicate effective program integrity practices across the states, CMS should collaborate with states to create and implement a communication strategy for sharing promising program integrity practices with states in an efficient and timely manner.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Carolyn Yocom
    Phone: (202) 512-7114

    2 open recommendations
    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 develop performance measures to assess outcomes of key efforts related to patients' electronic access to longitudinal health information. Such actions may include, for example, determining whether the number of providers that participate in these initiatives have higher rates of patient access to electronic health information.

    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: 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: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: King, Kathleen M
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: To ensure MACs' provider education efforts are focused on areas vulnerable to improper billing and to strengthen CMS's oversight of those efforts, CMS should require sufficient detail in MAC reporting to allow CMS to determine the extent to which MACs' provider education department efforts focus on areas identified as vulnerable to improper billing.

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

    Comments: HHS concurred with this recommendation and said it would take steps to implement it. In April 2017, CMS released a revised Provider Customer Service Program Activity Report (PAR) template to Medicare Administrative Contractors (MAC). This revised template collects additional information from MACs on their provider outreach and education activities that are specifically geared towards reducing their improper payment rate. All PAR Reports submitted after July 2017 will include information on these topics. Additionally, CMS is implementing increased reporting by MACs in the Provider Customer Service Program Contractor Information Database to track whether education was provided related to the prioritization of efforts to reduce the error rate. CMS expects these additional reporting requirements to be released to the MACs in fall 2017. GAO will continue to monitor CMS efforts.
    Recommendation: To ensure MACs' provider education efforts are focused on areas vulnerable to improper billing and to strengthen CMS's oversight of those efforts, CMS should explicitly require that Medicare Part A and B claims, DME, and home health and hospice MACs work together to educate referring providers on documentation requirements for DME and home health services.

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

    Comments: HHS concurred with this recommendation and said it would take steps to implement it. CMS is developing instructions for the Medicare Administrative Contractors (MAC) that will require MACs to collaborate on a regular basis to provide education to referring providers on documentation and other requirements relative to durable medical equipment and home health services. CMS expects these new instructions to be released to MACs in fall 2017. Additionally, CMS is implementing increased reporting by MACs in the Provider Customer Service Program Contractor Information Database to track the instances of collaboration with other MACs. CMS expects these additional reporting requirements to be released to the MACs in fall 2017. Finally, CMS revised the Provider Customer Service Program Activity Report (PAR) to collect additional information from MACs on education topics where MACs collaborated with each other and with external partners. This new template was released to MACs in April 2017, and all PARs submitted after July 2017 will include information on these topics. GAO will continue to monitor CMS efforts.
    Recommendation: To ensure MACs' provider education efforts are focused on areas vulnerable to improper billing and to strengthen CMS's oversight of those efforts, for any future probe and educate reviews, CMS should establish performance metrics that will help the agency determine the reviews' effectiveness in reducing improper billing.

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

    Comments: HHS concurred with this recommendation and said it would take steps to implement it. Through the Targeted Probe and Educate Pilot, currently under way in Jurisdiction F and set to expand in the near future to additional jurisdictions, CMS has been working to develop more thorough metrics to monitor the outcome and impact of the probe and educate reviews. Detailed metrics in the expanded pilot include service and provider specific error rates, claims metrics, financial impact, education metrics, provider/suppler behavior metrics, as well as volume and outcome of appeals both pre- and post-probe and educate implementation. GAO will continue to monitor CMS efforts.
    Director: Jessica Farb
    Phone: (202) 512-6991

    2 open recommendations
    Recommendation: To improve the reliability and usefulness of program evaluations for agency program and budget decisions, the Chief Executive Officer of MCC, the Administrator of USAID, the Secretary of Agriculture, the Secretary of Defense, the Secretary of State, and the Secretary of Health and Human Services (in cooperation with State's Office of the U.S. Global AIDS Coordinator and Health Diplomacy) should each develop a plan for improving the quality of evaluations for the programs included in our review, focusing on areas where our analysis has shown the largest areas for potential improvement.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In a response to GAO in May 2017, HHS stated that the CDC Operationalization of the Evaluation Standards of Practice (ESOP) was updated in January 2017 and provides guidance on evaluation planning, protocol development, implementation, reporting, dissemination, and use of evaluation results, as well as reporting requirements. HHS also stated that it now reviews all evaluation and performance monitoring plans and assess report quality at several stages prior to publication and has begun to provide webinars and templates for evaluators to ensure that standards are addressed and reflected in the report. GAO will review the updated documents and request documentation of the actions taken for responsiveness to our recommendation.
    Recommendation: To better ensure that the evaluation findings reach their intended audiences and are available to facilitate incorporating lessons learned into future program design or budget decisions, the Secretary of Health and Human Services should direct the Centers for Disease Control and Prevention to update its guidance and practices on the posting of evaluations to require President's Emergency Plan for AIDS Relief (PEPFAR) evaluations to be posted within the timeframe required by PEPFAR guidance.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In a response to GAO in May 2017, HHS stated that the CDC, as of December 2016, now provides guidance noting that each new evaluation protocol specifically state that a report on the main findings of an evaluation will be produced in alignment with the PEPFAR ESOP and posted (in English) on a publically accessible website within 90 days of completion. GAO will review the updated document for responsiveness to our recommendation.
    Director: John Neumann
    Phone: (202) 512-3841

    3 open recommendations
    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: HHS neither agreed nor disagreed with this recommendation, and as of July 2017, we await action from FDA.
    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: HHS neither agreed nor disagreed with this recommendation, and as of July 2017, we await action from FDA.
    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: HHS neither agreed nor disagreed with this recommendation, and as of July 2017, we await action from FDA.
    Director: Beryl H. Davis
    Phone: (202) 512-2623

    5 open recommendations
    including 3 priority recommendations
    Recommendation: The Secretary of Health and Human Services should direct the Assistant Secretary for Financial Resources to revise policies and procedures to reasonably assure that management decisions contain the required elements and are issued timely in accordance with OMB guidance.

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

    Comments: The Department of Health and Human Services (HHS) concurred with this recommendation to the Assistant Secretary for Financial Resources (ASFR). HHS stated that it will enhance the Grants Policy Administration Manual (issued on December 31, 2015) to provide additional details regarding the elements to be included in the management decisions letters. ASFR stated that it will use its established Single Audit Resolution Workgroup, comprised of representatives from the HHS agencies who are responsible for single audit resolution activities, to continually evaluate and strengthen its relevant policies and procedures. We will assess these efforts once completed.
    Recommendation: The Secretary of Health and Human Services should direct the Assistant Secretary for Financial Resources to design and implement policies and procedures for identifying and managing high-risk and recurring single audit findings using a risk-based approach.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: The Department of Health and Human Services (HHS) concurred with this recommendations to the Assistant Secretary for Financial Resources (ASFR). HHS stated that it is committed to ensuring that grantees submit single audits in a timely and complete manner and that its subagencies utilize the findings to ensure proper management of its grantees. HHS stated that ASFR is taking over the single audit assignment and tracking function from the OIG and that this realignment will allow HHS to better meet the requirements of the Uniform Guidance. HHS stated that it would continue to evaluate its policies and procedures to ensure compliance with regulations, particularly as ASFR takes over the single audit findings assignment and tracking function from the OIG. In addition, HHS stated that ASFR will work to develop policies and procedures that utilize a risk-based approach for high-risk and recurring single audit findings. We will assess these efforts once completed.
    Recommendation: The Secretary of Health and Human Services should direct the Administrator of the Centers for Medicare and Medicaid Services to revise its policies and procedures to take action to obtain single audit reports when award recipients did not submit reports within the required time frames.

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

    Comments: The Department of Health and Human Services (HHS) concurred with this recommendation to the Centers for Medicare and Medicaid Services (CMS). HHS stated that CMS has developed a Standard Operating Procedure (SOP) based on the Grants Policy Administration Manual (GPAM) issued December 31, 2015. The SOP is currently under review and will be implemented after approval and signature by CMS leadership. The SOP includes provisions for following up with entities that have delinquent audits. We will assess these efforts once completed.
    Recommendation: The Secretary of Health and Human Services should direct the Administrator of the Centers for Medicare and Medicaid Services to revise its policies and procedures to reasonably assure that management decisions contain the required elements and are issued timely in accordance with OMB guidance.

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

    Comments: The Department of Health and Human Services (HHS) concurred with this recommendation to the Centers for Medicare and Medicaid Services (CMS). HHS stated that it has developed a Standard Operating Procedure (SOP) based on the Grants Policy Administration Manual (GPAM) issued on December 31, 2015, and the draft Management Decision Letter (MDL) HHS guidelines document. In April 2017, HHS informed us that the SOP is under review and will be implemented after approval and signature by CMS leadership. The SOP includes management decision letter elements and the timely issuance of MDLs. We will assess these efforts once completed.
    Recommendation: The Secretary of Health and Human Services should direct the Administrator of the Centers for Medicare and Medicaid Services to design and implement policies and procedures for identifying and managing high-risk and recurring single audit findings using a risk-based approach.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: The Department of Health and Human Services (HHS) concurred with this recommendation to CMS. HHS stated that CMS plans to update the 1982 Health Care Financing Administration Audit Resolution Manual and will work collaboratively with HHS to develop policies and procedures that utilize a risk-based approach for high-risk and recurring single audit findings. We will assess these efforts once completed.
    Director: Joe Kirschbaum
    Phone: (202) 512-9971

    1 open recommendations
    Recommendation: As HHS plans to respond to a pandemic, the Secretary of Health and Human Services should direct the Assistant Secretary for Preparedness and Response to use HHS's existing coordination mechanisms with DOD and FEMA to explore opportunities to improve their preparedness and response to a pandemic if DOD's capabilities are limited.

    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.
    Director: Diana Maurer
    Phone: (202) 512-8777

    2 open recommendations
    Recommendation: To better ensure grantees' compliance with the Drug-Free Communities Support Program's statutory requirements and to strengthen monitoring of grantee activities, SAMHSA should develop an action plan with time frames for addressing any deficiencies it finds through its reviews and making systemic changes to mitigate deficiencies on a prospective basis to strengthen the grant monitoring process.

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

    Comments: As of April 2017, according to the Department of Health and Human Services, SAMHSA is currently in the process of implementing routine audits of all its grant files. SAMHSA will also conduct an audit specifically of DFC files to ensure compliance by the end of summer 2017. Additionally, SAMHSA will offer regular training to government project officers (GPO) on grant report requirements and will ensure DFC GPO participation. Finally, SAMHSA is actively implementing the Grants Enterprise Management System to streamline the grants management process and make the process for maintaining grant files automated. By the end of fall 2017, all newly awarded DFC grants will be in this system. By the end of fall 2018, all active DFC grants will utilize this system.
    Recommendation: To better ensure grantees' compliance with the Drug-Free Communities Support Program's statutory requirements and to strengthen monitoring of grantee activities, SAMHSA should develop and implement a method for ensuring that the grantee status reports it provides to ONDCP are complete and accurate.

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

    Comments: As of April 2017, according to the Department of Health and Human Services, SAMHSA will develop a plan to ensure complete and accurate information is provided to ONDCP by the end of summer 2017.
    Director: John E. Dicken
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: In order for drug sponsors to benefit from FDA's revised guidance on antibiotic development and take full advantage of the QIDP designation, FDA should clarify how drug sponsors should utilize draft guidance documents that were released in accordance with GAIN.

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

    Comments: HHS gave GAO information on its Good Guidance Practices, which provide that guidance documents are not binding on FDA or the public and that sponsors can use alternative approaches consistent with applicable statutes. HHS also noted that FDA issues guidance in draft form to solicit public comment before finalizing its current thinking and recommendations. This practice, as reflected by language on applicable QIDP draft guidance documents indicating that the guidance will represent FDA's current thinking "when finalized," created uncertainty for sponsors in planning their antibiotic drug development programs. Without clarifying the role of draft guidance in the QIDP designation and process, this uncertainty will continue to persist. GAO considers this recommendation open.
    Recommendation: In order for drug sponsors to benefit from FDA's revised guidance on antibiotic development and take full advantage of the QIDP designation, FDA should develop and make available written guidance on the QIDP designation that includes information about the process a drug sponsor must undertake to request the fast track designation and how the agency is applying the market exclusivity incentive.

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

    Comments: According to HHS, FDA intends to begin developing guidance on the QIDP designation and will eventually make this guidance publicly available.
    Director: Yocom, Carolyn L
    Phone: (202) 512-7114

    2 open recommendations
    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 the Centers for Medicare & Medicaid Services (CMS) and ONC to evaluate the effectiveness of HHS's key efforts to determine whether they are contributing to HHS's goal for increasing the use of EHRs and electronic exchange of health information in post-acute care settings.

    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: 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: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Katherine Iritani
    Phone: (202) 512-7114

    4 open recommendations
    Recommendation: To improve the collection of complete and consistent personal care services data and better ensure CMS can effectively monitor the states' provision of and spending on Medicaid personal care services, CMS should establish standard reporting guidance for personal care services collected through Transformed-MSIS (T-MSIS) to ensure that key data reported by states, such as procedure codes, provider identification numbers, units of service, and dates of service, are complete and consistent.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To improve the collection of complete and consistent personal care services data and better ensure CMS can effectively monitor the states' provision of and spending on Medicaid personal care services, CMS should better ensure, for all types of personal care services programs, that data on provision of personal care services and other home-and community-based services (HCBS) collected through T-MSIS claims can be specifically linked to the expenditure lines on the CMS-64 that correspond with those particular types of HCBS services.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To improve the collection of complete and consistent personal care services data and better ensure CMS can effectively monitor the states' provision of and spending on Medicaid personal care services, CMS should better ensure that personal care services data collected from states through T-MSIS and MBES comply with CMS reporting requirements.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To improve the collection of complete and consistent personal care services data and better ensure CMS can effectively monitor the states' provision of and spending on Medicaid personal care services, CMS should develop plans for analyzing and using personal care services data for program management and oversight.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Carolyn L. Yocom
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: To improve oversight of states' payment structures for MLTSS, the Administrator of CMS should require all states to collect and report on progress toward achieving MLTSS program goals, such as whether the program enhances the provision of community-based care.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To improve oversight of states' payment structures for MLTSS, the Administrator of CMS should establish criteria for what situations would warrant exceptions to the federal standards that the data used to set rates be no older than the three most recent and complete years.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To improve oversight of states' payment structures for MLTSS, the Administrator of CMS should provide states with guidance that includes minimum standards for encounter data validation procedures.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Kathy King
    Phone: (202) 512-7114

    1 open recommendations
    including 1 priority recommendation
    Recommendation: To help ensure that quality care is provided to AI/AN people, as part of the implementation of its quality framework, the Secretary of HHS should direct the Director of IHS to ensure that agency-wide standards for the quality of care provided in its federally operated facilities are developed, that facility performance in meeting these standards is systematically monitored over time, and that enhancements are made to its adverse event reporting system.

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

    Comments: HHS agreed with our recommendation and cited steps it already has underway to improve the quality of care in IHS's federally-operated facilities. HHS described the development of the IHS Quality Framework and Implementation Plan released in November 2016. However, as of June 2017, IHS had not developed agency-wide standards for the quality of care provided in its federally operated facilities.
    Director: Elizabeth H. Curda
    Phone: (202) 512-7114

    2 open recommendations
    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: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    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 develop a plan to evaluate states' and tribes' after-action reports to assess the impact of the reassignment authority on states' public health emergency response and medical surge and to provide technical assistance as necessary.

    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.
    Director: Carolyn L. Yocom
    Phone: (202) 512-7114

    1 open recommendations
    including 1 priority recommendation
    Recommendation: The Administrator of CMS should take immediate steps to assess and improve the data available for Medicaid program oversight, including, but not limited to, T-MSIS. Such steps could include (1) refining the overall data priority areas in T-MSIS to better identify those variables that are most critical for reducing improper payments, and (2) expediting efforts to assess and ensure the quality of these T-MSIS data.

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

    Comments: As of September 2017, CMS has begun targeted efforts to assess and improve T-MSIS data available for Medicaid program oversight, including initiating a pilot study with four states to identify data anomalies and obtaining input from external experts on data quality. However, because these initiatives are ongoing and further efforts to improve T-MSIS data are still evolving, this recommendation remains open.
    Director: Kay E. Brown
    Phone: (202) 512-7215

    1 open recommendations
    Recommendation: To help states effectively address ongoing challenges related to ensuring the appropriate use of psychotropic medications for children in foster care, the Secretary of HHS should consider cost-effective ways to convene state child welfare, Medicaid, and other stakeholders to promote collaboration and information sharing within and across states on psychotropic medication oversight.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS agreed with this recommendation and provided examples of the virtual convening of contingency groups they employed to provide technical assistance and peer to peer networking in child welfare. The agency plans to offer additional technical assistance that is specifically related to the topic of mental health and psychotropic medication. GAO will consider closing the recommendation when the agency completes these efforts.
    Director: Marcia Crosse
    Phone: (202) 512-7114

    2 open recommendations
    including 1 priority recommendation
    Recommendation: To help ensure that FDA's foreign offices are able to fully meet their mission of helping to ensure the safety of imported products, as the agency continues to test performance measures and evaluate its Office of International Programs (OIP) strategic workforce plan, the Commissioner of FDA should assess the effectiveness of the foreign offices' contributions by systematically tracking information to measure whether the offices' activities specifically contribute to drug safety-related outcomes, such as inspections, import alerts, and warning letters.

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

    Comments: HHS concurred with this recommendation and stated that FDA plans to conduct internal annual reviews of its foreign offices' performances and track their contributions by type of commodity. We will assess these actions once they have been completed.
    Recommendation: To help ensure that FDA's foreign offices are able to fully meet their mission of helping to ensure the safety of imported products, as the agency continues to test performance measures and evaluate its OIP strategic workforce plan, the Commissioner of FDA should establish goals to achieve the appropriate staffing level for its foreign offices, which would include separating foreign office vacancies from the OIP-wide vacancy rate, and setting goals by position type.

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

    Comments: HHS concurred with this recommendation. HHS said that the strategic workforce plan for FDA's foreign offices will be updated to reflect the disaggregation of performance measures that track foreign office vacancy rates and targets by position type. We will assess these actions once they have been completed.
    Director: Elizabeth H. Curda
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: In order to ensure that the agency is adequately protecting the White Oak campus as a designated high-risk facility and strategically planning for the White Oak campus's future, as FDA moves forward with its proposed planning efforts, the Commissioner of FDA, in consultation with the Administrator of GSA, should implement vehicular access control measures on the White Oak campus to meet the requirements of the high-risk facility level designation assigned in the 2014 risk assessment report, or fully document the rationale for any deviations from these requirements.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: In order to ensure that the agency is adequately protecting the White Oak campus as a designated high-risk facility and strategically planning for the White Oak campus's future, as FDA moves forward with its proposed planning efforts, the Commissioner of FDA, in consultation with the Administrator of GSA, should further incorporate leading strategic facilities planning practices into FDA's proposed planning efforts by ensuring that FDA establish strategic linkage between its strategic priorities and its facilities plans.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: In order to ensure that the agency is adequately protecting the White Oak campus as a designated high-risk facility and strategically planning for the White Oak campus's future, as FDA moves forward with its proposed planning efforts, the Commissioner of FDA, in consultation with the Administrator of GSA, should document the key information related to daily operational activities and ongoing benefits and challenges that are needed to inform FDA's proposed planning efforts in the areas of needs assessment, gap identification, and alternatives analysis, and incorporate into proposed planning efforts a detailed strategy for collecting and analyzing this information.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Powner, David A
    Phone: (202) 512-9286

    1 open recommendations
    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 has provided a written response to this recommendation and we are currently evaluating it.
    Director: Katherine Iritani
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: To achieve a better understanding of the effect of certain Personal care services (PCS) services on beneficiaries and a more consistent administration of policies and procedures across PCS programs, the Acting Administrator of CMS should collect and analyze states' required information on the impact of the Participant-Directed Option and Community First Choice programs on the health and welfare of beneficiaries as well as the state quality measures for the Participant-Directed Option and Community First Choice programs.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To achieve a better understanding of the effect of certain PCS services on beneficiaries and a more consistent administration of policies and procedures across PCS programs, the Acting Administrator of CMS should take steps to harmonize requirements, as appropriate, across PCS programs in a way that accounts for common risks faced by beneficiaries and to better ensure that billed services are provided.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: A. Nicole Clowers
    Phone: (202) 512-7114

    4 open recommendations
    Recommendation: To strengthen CMS's efforts to improve the usefulness of the Nursing Home Compare website for consumers, the Administrator of CMS should establish a systematic process for reviewing potential website improvements that includes and describes steps on how CMS will prioritize the implementation of potential website improvements.

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

    Comments: HHS concurred with this recommendation and reported that CMS is working to develop a method that would track potential changes to Nursing Home Compare. We will update the status of this recommendation when we receive further information.
    Recommendation: To help improve the Five-Star System's ability to enable consumers to understand nursing home quality and make distinctions between high- and low- performing homes, the Administrator of CMS should add information to the Five-Star System that allows consumers to compare nursing homes nationally.

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

    Comments: HHS did not concur with this recommendation. However, we maintain that adding national comparison information is important.
    Recommendation: To help improve the Five-Star System's ability to enable consumers to understand nursing home quality and make distinctions between high- and low- performing homes, the Administrator of CMS should evaluate the feasibility of adding consumer satisfaction information to the Five-Star System.

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

    Comments: HHS concurred with this recommendation and reported that CMS is evaluating the feasibility of adding consumer satisfaction to Nursing Home Compare. We will update the status of this recommendation when we receive further information.
    Recommendation: To help improve the Five-Star System's ability to enable consumers to understand nursing home quality and make distinctions between high- and low- performing homes, the Administrator of CMS should develop and test with consumers introductory explanatory information on the Five-Star System to be prominently displayed on the home page. Such information should explain, for example, how the overall rating is calculated, the importance of the component ratings, where to find information on the timeliness of the data, and whether the ratings can be used to compare nursing homes nationally.

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

    Comments: HHS concurred with this recommendation and reported that CMS is in the process of revising the explanatory language on Nursing Home Compare and plans to implement those changes on the website in late 2017. We will update the status of this recommendation when we receive further information.
    Director: Kathleen M. King
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To improve the efficiency and effectiveness of the agency's enrollment screening process, the Administrator of CMS should establish objectives and performance measures for assessing progress toward achieving its goals.

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

    Comments: As of August 2017, the Department of Health and Human Services (HHS) considers this recommendation still open. HHS noted that the Centers for Medicare & Medicaid Services is planning to implement this recommendation in early 2018. GAO will continue to monitor the agency's progress and will update the status of the recommendation when we receive additional information.
    Director: Clowers, Angela N
    Phone: (202) 512-7114

    2 open recommendations
    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 2017, HHS told us that ONC and CMS are prioritizing efforts to understand challenges associated with the development and implementation of electronic clinical quality measures. However, we determined that the actions did not fully address the recommendation because they focus on efforts to understand the challenges associated with electronic clinical quality measures as opposed to efforts to prioritize their development of measures from the core measure sets that CMS and private payers have agreed to use. As of August 2017, HHS officials have not informed us of any additional actions taken to implement this recommendation. We will update the status of this recommendation when we receive additional information.
    Recommendation: 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 January 2017, HHS told us that it considers this recommendation open and CMS will continue to explore ways for greater alignment through its planning efforts. As of August 2017, HHS officials have not informed us of any additional actions taken to implement this recommendation. We will update the status of this recommendation when we receive additional information.
    Director: David Powner
    Phone: (202) 512-9286

    1 open recommendations
    Recommendation: To improve federal agencies' efforts to rationalize their portfolio of applications, the heads of the Departments of Agriculture, Commerce, Education, Energy, Health and Human Services, Housing and Urban Development, the Interior, Labor, State, Transportation, the Treasury, and Veterans Affairs; and heads of the Environmental Protection Agency; National Aeronautics and Space Administration; National Science Foundation; Nuclear Regulatory Commission; Office of Personnel Management; Small Business Administration; Social Security Administration; and U.S. Agency for International Development should direct their Chief Information Officers (CIOs) and other responsible officials to improve their inventories by taking steps to fully address the practices we identified as being partially met or not met.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In its comments on a draft of our report, the department concurred with our recommendation. Subsequent to the department informing us that it has taken action to implement the recommendation, we will follow up.
    Director: James Cosgrove
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: To improve the accessibility and reliability of SNF expenditure data, the Acting Administrator of CMS should take steps to improve the accessibility of SNF expenditure data, making it easier for public stakeholders to locate and use the data.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To improve the accessibility and reliability of SNF expenditure data, the Acting Administrator of CMS should take steps to ensure the accuracy and completeness of SNF expenditure data.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Beryl H. Davis
    Phone: (202) 512-2623

    6 open recommendations
    Recommendation: To improve the design of internal controls over the indirect cost rate-setting process, the Director of CAS should develop a standardized checklist and document procedures in its internal guidance instructing negotiators to use the checklist during negotiation.

    Agency: Department of Health and Human Services: Division of Cost Allocation
    Status: Open

    Comments: HHS concurred with this recommendation. In response, HHS stated that its Cost Allocation Services (CAS) will update and complete standardized checklists and that staff will be instructed to use these checklists by December 31, 2016. We are currently reviewing support received from HHS to determine if we can close the recommendation.
    Recommendation: To improve the design of internal controls over the indirect cost rate-setting process, the Director of CAS should develop detailed internal guidance for the completion and documentation of supervisory review of the indirect cost rate negotiation process to provide reasonable assurance that key control activities have been performed by the negotiators.

    Agency: Department of Health and Human Services: Division of Cost Allocation
    Status: Open

    Comments: HHS concurred with this recommendation. In response, HHS stated that by December 31, 2016, its Cost Allocation Services (CAS) will establish a document outlining standardized review procedures for supervisory review of workpapers and rate agreements. We are currently reviewing support received from HHS to determine if we can close the recommendation.
    Recommendation: To improve the design of internal controls over the indirect cost rate-setting process, the Director of CAS should develop internal guidance for negotiating indirect cost rates with all types of research organizations, including hospitals, as well as universities using the simplified method.

    Agency: Department of Health and Human Services: Division of Cost Allocation
    Status: Open

    Comments: HHS concurred with this recommendation. In response, HHS stated that its Cost Allocation Services (CAS) will update internal guidance for negotiating indirect cost rates with universities using the simplified method by December 31, 2016. This guidance will include an example under the two types of direct cost bases, a salary and wage base and a modified total direct cost base. CAS will develop internal guidance for negotiating with hospitals as soon as possible. We are currently reviewing support received from HHS to determine if we can close the recommendation.
    Recommendation: As NIH-DFAS begins formalizing its internal guidance, the Director of NIH-DFAS should update internal guidance to include key characteristics, such as policy number, purpose of the policy, effective date, and approving official, that are normally included in formal policy and procedures.

    Agency: Department of Health and Human Services: Public Health Service: National Institutes of Health: Office of Management: Office of Acquisition and Logistics Management: Office of Acquisition Management and Policy: Division of Financial Advisory Services
    Status: Open

    Comments: HHS concurred with this recommendation. In response, HHS stated that by December 31, 2016, National Institute of Health's Division of Financial Advisory Services (DFAS) will update internal guidance to include key characteristics that are normally included in formal policy and procedures. NIH-DFAS has finalized three of the five polices, which are effective as of July 1, 2017. The remaining two policies will be finalized by August 31st, 2017. We will continue to monitor the status of this recommendation.
    Recommendation: As NIH-DFAS begins formalizing its internal guidance, the Director of NIH-DFAS should develop detailed procedures for the completion and documentation of supervisory review of the indirect cost rate negotiation process to provide reasonable assurance that key control activities have been performed by the negotiator.

    Agency: Department of Health and Human Services: Public Health Service: National Institutes of Health: Office of Management: Office of Acquisition and Logistics Management: Office of Acquisition Management and Policy: Division of Financial Advisory Services
    Status: Open

    Comments: HHS concurred with this recommendation. In response, HHS stated that the National Institute of Health's Division of Financial Advisory Services (DFAS), will develop detailed procedures for the completion and documentation of supervisory review of the indirect cost rate negotiations process. NIH-DFAS has developed draft internal guidance to address the supervisory review of the indirect cost negotiation process. NIH-DFAS plans to finalize these procedures by August 31, 2017. We will continue to monitor the status of this recommendation.
    Recommendation: As NIH-DFAS begins formalizing its internal guidance, the Director of NIH-DFAS should establish a mechanism for tracking key milestones in the indirect cost rate-setting process, such as when indirect cost rate proposals are due.

    Agency: Department of Health and Human Services: Public Health Service: National Institutes of Health: Office of Management: Office of Acquisition and Logistics Management: Office of Acquisition Management and Policy: Division of Financial Advisory Services
    Status: Open

    Comments: HHS concurred with this recommendations. In response, HHS stated that National Institute of Health's Division of Financial Advisory Services (DFAS) will establish a mechanism for tracking key milestones in the indirect cost rate-setting process. NIH-DFAS has initiatives underway that include moving from paper to electronic submissions of indirect cost proposals and developing a replacement to its Commercial Rate Agreement Distribution Services website. DFAS is looking into the feasibility of incorporating key milestones into these two major initiatives. NIH-DFAS is currently working with a contractor to develop a web based system that will establish a tracking system to account for when indirect cost proposal are due from organizations. The original initiative to enable the electronic submission of indirect cost proposals was modified to incorporate this new requirement. NIH-DFAS anticipates the planned date for implementation of this system to be October 1, 2017. We will continue to monitor the status of this recommendation.
    Director: Gregory C. Wilshusen
    Phone: (202) 512-6244

    3 open recommendations
    Recommendation: To effectively implement key elements of the FDA's information security program, the Secretary of Health and Human Services should direct the Commissioner of FDA to update security plans to ensure the plans fully and accurately document the controls selected and intended for protecting each of the six systems.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: FDA concurred with the recommendation but has not yet provided sufficient evidence that it has implemented the recommendation.
    Recommendation: To effectively implement key elements of the FDA's information security program, the Secretary of Health and Human Services should direct the Commissioner of FDA to implement a process to effectively monitor and track training for personnel with significant security roles and responsibilities.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: FDA concurred with the recommendation but has not yet provided sufficient evidence that it has implemented the recommendation.
    Recommendation: To effectively implement key elements of the FDA's information security program, the Secretary of Health and Human Services should direct the Commissioner of FDA to ensure that personnel with significant security responsibilities receive role-based training.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: FDA concurred with the recommendation but has not yet provided sufficient evidence that it has implemented the recommendation.
    Director: Persons, Timothy M
    Phone: (202) 512-6412

    6 open recommendations
    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 July 2017, 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 2 to 3 years.
    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 CDC and NIH to revise reporting forms within their respective areas of oversight to help identify when incidents involving incomplete inactivation occur and analyze the information reported to help identify the causes of incomplete inactivation to mitigate the risk of future incidents.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In March 2017, officials from the Federal Select Agent Program told us that they are in the process of modifying the program's incident reporting form to include reporting of inactivation failures, with completion anticipated by summer 2017. In addition, in August 2016, the National Institutes of Health (NIH) revised its template for reporting incidents subject to the NIH Guidelines to include a specific checkbox for entities to identify incidents that involve incomplete inactivation.
    Recommendation: To increase scientific information on inactivation and viability testing, the Secretaries of Health and Human Services and Agriculture should coordinate research efforts and take actions to help close gaps in the science of inactivation and viability testing across high-containment laboratories.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In March 2017, Department of Health and Human Services (HHS) officials stated that the department, in coordination with the United States Department of Agriculture (USDA), has examined current gaps related to inactivation and are in the process of taking steps to increase research on applied biosafety, in part to improve scientific understanding of processes for inactivation in high-containment laboratories. We are waiting for documentation and timeframes for implementation.
    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 March 2017, 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 2 to 3 years.
    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 by 2020. HHS plans to release the updated manual in 2 to 3 years.
    Recommendation: To help ensure more consistent enforcement for violations involving incomplete inactivation of select agents, the Secretary of Health and Human Services should direct CDC to develop and implement consistent criteria and documentation requirements for referring violations to investigative entities and enforcing regulations related to incidents involving incomplete inactivation.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In September 2017, the Federal Select Agent Program finalized a document that provides criteria on when to refer violations and options for enforcement. The document categorizes regulatory departures, grouped by level of risk, along a spectrum of severity with associated enforcement options. In addition, the Centers for Disease Control and Prevention worked with the Department of Health and Human Services (HHS) Office of Inspector General (OIG) to develop a policy document that outlines criteria for referring violations to the HHS OIG. One of the criterion for referral is any departure from the select agent regulations that creates a danger to public health and safety. This policy document was finalized in June 2017. The program continues to develop associated documentation requirements for referring violations to investigative entities and enforcing regulations.
    Director: Gregory C. Wilshusen
    Phone: (202) 512-6244

    5 open recommendations
    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 update security guidance for covered entities and business associates to ensure that the guidance addresses implementation of controls described in the National Institute of Standards and Technology Cybersecurity Framework.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS concurred with the recommendation and plans to implement it. Subsequent to the agency stating that is has taken action, we plan to verify whether implementation has occurred.
    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 update technical assistance that is provided to covered entities and business associates to address technical security concerns.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS concurred with the recommendation and plans to implement it. Subsequent to the agency stating that is has taken action, we plan to verify whether implementation has occurred.
    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 revise the current enforcement program to include following up on the implementation of corrective actions.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS neither concurred nor nonconcurred with the recommendation but plans to implement it. Subsequent to the agency stating that is has taken action, we plan to verify whether implementation has occurred.
    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: HHS concurred with the recommendation and plans to implement it. Subsequent to the agency stating that is has taken action, we plan to verify whether implementation has occurred.
    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 and implement policies and procedures for sharing the results of investigations and audits between OCR and Centers for Medicare & Medicaid Services to help ensure that covered entities and business associates are in compliance with the Health Insurance Portability and Accountability Act of 1996 and the Health Information Technology for Economic and Clinical Health Act.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS neither concurred nor nonconcurred with the recommendation but plans to implement it. Subsequent to the agency stating that is has taken action, we plan to verify whether implementation has occurred.
    Director: Gregory C. Wilshusen
    Phone: (202) 512-6244

    1 open recommendations
    Recommendation: To ensure that the role of the CISO is defined in department policy in accordance with FISMA 2014, the Secretary of Health and Human Services should define the CISO's role in department policy for ensuring that plans and procedures are in place to ensure recovery and continued operations of the department's information systems in the event of a disruption.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: The Department of Health and Human Services concurs with our recommendation but has not yet provided sufficient evidence that it has implemented the recommendation.
    Director: Kathleen M. King
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To improve available data about the direct care workforce, the Acting Administrator of the Health Resources and Services Administration should take steps to produce projections of direct care workforce supply and demand and develop methods to address data limitations in order to do so.

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

    Comments: HHS concurred with this recommendation, agreeing that developing projections of the direct care workforce is timely and important. Since the release of the report, HHS's Health Resources and Services Administration (HRSA) published a fact sheet presenting national demand projections for nursing assistants and home health aides. HRSA also reported awarding a contract to develop a projection model for the supply, demand, and distribution of long-term service and support providers. The agency expects reports from this model to be available in 2018.
    Director: David A. Powner
    Phone: (202) 512-9286

    2 open recommendations
    Recommendation: To improve the quality of the seven departments' information on project incremental delivery reported to the IT Dashboard, the Secretaries of Commerce, Defense, Education, Health and Human Services, Homeland Security, Transportation, and the Treasury should direct their CIOs to review major IT investment project data reported on the IT Dashboard and update the information as appropriate in the following areas: (1) whether the project is in-progress or complete; (2) whether the project is a software development project or not; and (3) the status of the delivery of functionality every 6 months, ensuring that these data are consistent across all reporting channels.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: The Department of Health and Human Services (HHS) concurred with our recommendation. However, after our report was issued in August 2016, the IT Dashboard was not publicly updated from the end of August 2016 until the end of May 2017, during the formulation of the President's budget request. Now that the Dashboard is being publicly updated again, we will continue to analyze and monitor the department's progress in updating investment information on the Dashboard and the implementation of our 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 to establish a departmentwide certification policy. However, HHS officials reported in April 2017 that they did not have a timeframe for when the department's new certification guidance would be completed. Until this guidance is finalized, HHS will not be able to fully ensure adequate implement of, or benefit from, incremental development practices. We will continue to evaluate HHS's progress in implementing this recommendation.
    Director: Kay Brown
    Phone: (202) 512-7215

    1 open recommendations
    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. The agency noted that some tribal-state agreements might predate 2008, when GAP was established. HHS also said that regional office staff participate annually in joint planning for the title IV-B and IV-E programs with their respective states and tribes and that participation in GAP is a topic covered in joint planning activities. In addition, HHS said that regional office staff are available to assist states and tribes with discussions about GAP participation when tribal-state agreements are renegotiated and that technical assistance is available to tribes, if needed. According to HHS, the agency plans to add information to the Children's Bureau website about direct federal funding for tribal title IV-E agencies and about tribal-state partnership agreements and plans to distribute issue briefs on GAP and best practices for tribal-state agreements. We agree that HHS has the planning process, technical assistance resources, and regional staff in place to discuss GAP participation with title IV-E state and tribal agency officials. However, our review found that tribal participation in GAP remains low, which suggests that HHS needs to identify actions to increase participation in this program. We believe that the additional actions HHS plans to take - providing information on the Children's Bureau website about direct funding and distributing issue briefs on GAP and best practices for tribal - state partnerships and agreements - could support tribes' participation in GAP either by helping tribes to directly operate a title IV-E program or to negotiate a tribal-state agreement that includes a provision for GAP participation. Because some tribes reported challenges at the state level to participating in GAP and several tribes reported that the state where they are located does not participate in the program, we encourage HHS to engage title IV-E state agency officials in discussions about tribal participation in GAP during the annual review of the their title IV-E state plan. HHS could identify ways that regional office staff might help state agencies resolve any challenges to GAP participation that tribes experience at the state level. HHS has taken several steps over the past few years to help tribes with their title IV-E programs, including hiring a tribal coordinator to facilitate communication between regional offices and tribal title IV-E agencies. Taking additional steps to ensure that tribes have the opportunity to participate in GAP could go a long way toward helping tribes gain more resources for children under their care and better support tribes' efforts to care for children exiting foster care to permanent homes.
    Director: Gretta L. Goodwin
    Phone: (202) 512-8777

    1 open recommendations
    Recommendation: To enhance the clarity and transparency of sexual violence data that is reported to the public, the Secretary of Education should direct the Assistant Secretary for the Office of Postsecondary Education, the Secretary of Health and Human Services should direct the Director of Centers for Disease Control and Prevention, and the Attorney General should direct the Director of the Bureau of Justice Statistics to make information on the acts of sexual violence and contextual factors that are included in their measurements of sexual violence publicly available. This effort could entail revising their definitions of key terms used to describe sexual violence so that the definitions match the measurements of sexual violence.

    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.
    Director: Yvonne D. Jones
    Phone: (202) 512-6806

    1 open recommendations
    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. HHS stated the agency is currently 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.
    Director: James Cosgrove
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: CMS should periodically verify the sales price data submitted by a sample of drug manufacturers by requesting source documentation from manufacturers to corroborate the reported data, either directly or by working with the HHS Office of Inspector General as necessary.

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

    Comments: In its comments on a draft of this report, HHS concurred with this recommendation. HHS stated that it will continue to work with the Office of Inspector General (OIG) as appropriate to collect source documentation from drug manufacturers and take action as may be warranted. HHS also stated that OIG reviews and compares the submitted average sales price (ASP) to the average manufacturer price (AMP) for Medicare Part B drugs and CMS has the authority to adjust ASP-based payment amounts when the difference between the two rates reaches a certain threshold. We do not consider this recommendation closed because CMS only collects source documentation from manufacturers under very limited circumstances (e.g., when there are obvious inconsistencies in the data submitted by manufacturers). CMS does not periodically request source documentation, such as sales invoices, from a sample of drug manufacturers to verify that the reported data reflect actual sales prices. As of August 17, 2017, CMS has not provided any additional information about actions to address this recommendation.
    Director: Katherine Iritani
    Phone: (202) 512-7114

    2 open recommendations
    including 2 priority recommendations
    Recommendation: To ensure efficient use of federal resources, the Administrator of CMS should improve alignment of Medicare UC payments with hospital uncompensated care costs by basing these payments on hospital uncompensated care costs.

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

    Comments: The Department of Health and Human Services concurred with this recommendation and indicated that the agency planned to implement it beginning in fiscal year 2021 to allow time for hospitals to collect and report reliable uncompensated care cost data. We believe this action could be implemented sooner.
    Recommendation: To ensure efficient use of federal resources, the Administrator of CMS should account for Medicaid payments a hospital has received that offset uncompensated care costs when determining hospital uncompensated care costs for the purposes of making Medicare UC payments to individual hospitals.

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

    Comments: The Department of Health and Human Services concurred with this recommendation and indicated that the agency planned to implement it beginning in fiscal year 2021 to allow time for hospitals to collect and report reliable uncompensated care cost data. We believe this action could be implemented sooner.
    Director: Marcia Crosse
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: To make the best use of federal resources directed toward combating FGM/C in the United States, the Attorney General and the Secretaries of Education, Health and Human Services, Homeland Security, and State should each develop a written plan that describes the agency's approach for conducting education and outreach to key stakeholders in the United States regarding FGM/C.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: The Department of Health and Human Services (HHS) concurred with this recommendation, and noted in a September 2016 update that various HHS offices and agencies are working together to develop a written plan for its approaches to addressing FGM/C. In August 2017, HHS reported that once a key leadership position has been filled, it will provide more information on developing a written plan.
    Recommendation: To make the best use of federal resources directed toward combating FGM/C in the United States, the Attorney General and the Secretaries of Education, Health and Human Services, Homeland Security, and State should each communicate the plan with other relevant federal agencies and stakeholder groups, as appropriate.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: The Department of Health and Human Services (HHS) concurred with this recommendation, and noted in a September 2016 update that various HHS offices and agencies are working together to develop a written plan for its approaches to addressing FGM/C. HHS also noted that it would share this plan with other federal partners and key stakeholders. In August 2017, HHS reported that once a key leadership position has been filled, it will provide more information on disseminating a written plan.
    Director: John Neumann
    Phone: (202) 512-3841

    3 open recommendations
    Recommendation: To reduce pre-award administrative workload and costs, particularly for applications that do not result in awards, the Secretary of Energy, the NASA Administrator, and the Secretary of Health and Human Services should conduct agency-wide reviews of possible actions, such as further use of preliminary proposals, to postpone pre-award requirements until after a preliminary decision about an applicant's likelihood of funding and, through OSTP's Research Business Models working group, coordinate and report on these efforts.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: According to HHS, NIH is considering the feasibility of an approach to streamline its application process. As of May 2017, HHS anticipated implementing this recommendation by early fiscal year 2019.
    Recommendation: To better target requirements on areas of greatest risk, while maintaining accountability over grant funds, the Secretary of Health and Human Services, as part of the planned evaluation of the HHS regulation governing financial conflicts of interest in NIH-funded research, should evaluate options for targeting requirements on areas of greatest risk for researcher conflicts, including adjusting the threshold and types of financial interests that need to be disclosed and the timing of disclosures.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS stated that, as of May 2017, NIH was proceeding with plans to assess the financial conflict of interest regulation, including how to reduce administrative burden on researchers while maintaining the integrity and credibility of research findings.
    Recommendation: To further standardize administrative research requirements, the Secretary of Energy, the NASA Administrator, the Secretary of Health and Human Services, and the Director of NSF should coordinate through Office of Science and Technology Policy's (OSTP) Research Business Models working group to identify additional areas where they can standardize requirements and report on these efforts.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In January 2017, the American Innovation and Competitiveness Act was signed into law, requiring the Office of Management and Budget, in coordination with the Office of Science and Technology Policy, to establish an interagency working group to reduce administrative workload and costs while protecting the transparency of and accountability for federally funded research. As of March 2017, DOE, HHS, NASA, and NSF stated that, as part of their efforts to implement GAO's recommendation, they would coordinate with other research funding agencies through this interagency working group.
    Director: J. Christopher Mihm
    Phone: (202) 512-6806

    1 open recommendations
    Recommendation: To improve the public reporting of major management challenges and to ensure performance information is useful, transparent, and complete, the Secretary of Health and Human Services (HHS) should include performance goals, milestones and an agency official responsible for resolving each of HHS's major management challenges as part of HHS's agency performance plan.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: According to its website, for fiscal year 2018, HHS is meeting its performance reporting requirements as designated in the GPRA Modernization Act of 2010 and OMB Circular A-11 through the program performance information provided in the FY 2018 HHS Budget Justifications to Congress. As of August 2017, however, HHS has not taken action to implement our recommendation. Our review of HHS' 2018 Congressional Budget Justification found that it did not include recommended information. When the 2019 CBJ is issued, we will update the status of this recommendation.
    Director: David A. Powner
    Phone: (202) 512-9286

    2 open recommendations
    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 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. When we confirm what actions have been taken, we will update.
    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 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. When we confirm what actions have been taken, we will update.
    Director: Steve Morris
    Phone: (202) 512-3841

    1 open recommendations
    Recommendation: To further enhance FDA's PREDICT tool and its ability to ensure the safety of imported food, the Secretary of Health and Human Services should direct the Commissioner of FDA to document the process for identifying the type of open source data to collect, obtaining such data, and determining how PREDICT is to use the data.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of February 2017, GAO was awaiting action by the agency to implement this recommendation.
    Director: David A. Powner
    Phone: (202) 512-9286

    1 open recommendations
    Recommendation: To address obsolete IT investments in need of modernization or replacement, the Secretaries of Agriculture, Commerce, Defense, Energy, Health and Human Services, Homeland Security, State, the Treasury, Transportation, and Veterans Affairs; the Attorney General; and the Commissioner of Social Security should direct their respective agency CIOs to identify and plan to modernize or replace legacy systems as needed and consistent with OMB's draft guidance, including time frames, activities to be performed, and functions to be replaced or enhanced.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: The agency agreed with the recommendation and in a September 2016 written update stated that the office of the CIO is working to identify and plan to modernize or replace IT systems. As of July 2017, the agency had not responded to requests for updates on the implementation of this recommendation. We will continue to monitor this recommendation.
    Director: Melissa Emrey-Arras
    Phone: (617) 788-0534

    2 open recommendations
    Recommendation: To help foster and unaccompanied homeless youth better navigate the college admissions and federal student aid processes, the Secretaries of Education and HHS should jointly study potential options for encouraging and enabling child welfare caseworkers, McKinney-Vento homeless youth liaisons, and other adults who work with these youth to more actively assist them with college planning.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS, working with the Department of Education, issued a Foster Youth Transition Toolkit in May 2016 which encourages current and former foster youth to pursue college and addresses both financial aid and college admissions processes. The toolkit was written for youth in or formerly in foster care, and HHS considers it a resource for unaccompanied homeless youth as well as for the adults who serve these youth. Making such information available through this joint publication is an encouraging step. However, child welfare caseworkers, school homelessness liaisons, and other professionals who work with homeless and foster youth have competing goals and priorities and multiple responsibilities. To encourage and facilitate college planning and admissions efforts, Education and HHS would need to carefully consider professional staff's workloads, responsibilities, and training needs, among other issues, and develop some options for encouraging college planning efforts among professionals in these programs who work with homeless and foster youth.
    Recommendation: To simplify program rules for Chafee ETV vouchers and improve access to these vouchers for former foster youth ages 21 and 22, the Secretary of HHS should consider developing a legislative proposal for congressional action to allow foster youth to be eligible for the Chafee ETV voucher until age 23 without also requiring that they start using the voucher before they turn 21.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS's budget request for fiscal year 2018 does not contain a legislative proposal to improve access to Chafee vouchers for former foster youth ages 21 and 22. In July 2016, HHS noted that it had made a proposal for mandatory programs to improve foster youth's access to vouchers for title IV-E Chafee programs in the Administration for Children and Families' fiscal year 2017 budget request. However, the agency explained that the proposal's purpose is to extend eligibility for Chafee Foster Care Independence Program (CFCIP) services to youth up to age 23 in jurisdictions that have extended foster care to age 21. According to HHS, the budgetary proposal does not affect the Chafee Vouchers. A legislative proposal to simplify program rules for Chafee ETV vouchers would support improving access to these vouchers for former foster youth ages 21 and 22.
    Director: Marcia Crosse
    Phone: (202) 512-7114

    2 open recommendations
    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: On 9/6/16, FDA provided an update on its actions to address this recommendation. FDA concurred with the recommendation and reiterated that it plans to identify opportunities for setting measurable goals related to regulatory science. The agency indicated that it would provide an update by 3/6/17.
    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: On 9/6/16, FDA provided an update on its actions to address this recommendation. FDA concurred with the recommendation and reiterated that it is identifying mechanisms to improve its tracking of funding across the priority areas. The agency indicated that it would provide an update by 3/6/17.
    Director: Marcia Crosse
    Phone: (202) 512-7114

    1 open recommendations
    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: On 9/8/16, FDA provided an update on its actions to address this recommendation. FDA concurred with the recommendation and reiterated that it had started a process to identify key crosscutting themes for the medical products centers, which it would then use to develop an overarching strategic planning framework to guide the work of these centers. The agency indicated that it would provide additional updates in fiscal year 2018.
    Director: Kathleen King
    Phone: (202) 512-7114

    3 open recommendations
    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 September 2017, HHS officials have not implemented this recommendation. We will update the status of this recommendation when we receive additional information.
    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 September 2017, HHS officials have not implemented this recommendation. We will update the status of this recommendation when we receive additional information.
    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. Specifically, HHS stated that, in November 2016, CMS will modify MAS to standardize appeal categories between Levels 1 through 3 and that OMHA will incorporate the standardized MAS appeal categories for Levels 1 and 2 into ECAPE in its next release. DAB will also work to incorporate these standardized categories into its new appeals data system. In addition, HHS reported that CMS is working to modify MAS to collect additional information related to appeal decisions. As of September 2017, HHS officials have not implemented this recommendation. We will update the status of this recommendation when we receive additional information.
    Director: Cindy Brown Barnes
    Phone: (202) 512-7215

    1 open recommendations
    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. The agency reported that it would reach out to stakeholders, such as worker unions, USDA and OSHA, to discuss the range of types of study that could be conducted to provide useful information. GAO will await the progress of this effort and close the recommendation when the agency initiates a study.
    Director: Carolyn L. Yocom
    Phone: (202) 512-7114

    3 open recommendations
    including 2 priority recommendations
    Recommendation: To improve the effectiveness of states' and plans' Medicaid managed care (MMC) plan provider screening efforts, the Acting Administrator of CMS should consider which additional databases that states and MMC plans use to screen providers could be helpful in improving the effectiveness of these efforts and determine whether any of these databases should be added to the list of databases identified by CMS for screening purposes.

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

    Comments: HHS concurred with this recommendation. CMS analyzed 22 databases that were reported to GAO as being used by Medicaid managed care plans to screen providers. It determined that several were already in use by CMS and mentioned in its guidance, several required more study by CMS, and others were not reliable. In April 2017, we reviewed CMS's analysis. For 8 of the databases, CMS noted that more information is needed, including the availability of the data and whether CMS would need an identifier to link providers to the data. CMS has requested additional information for these databases and has not yet concluded whether the databases should be added to the list of databases it has identified for screening purposes. To close the recommendation, CMS will need to determine whether the remaining databases it has studied should be added to the CMS list of databases to be used for provider screening and take the appropriate action.
    Recommendation: To improve the effectiveness of states' and plans' MMC plan provider screening efforts, the Acting Administrator of CMS should collaborate with SSA to facilitate sharing CMS's Death Master File subscription with state Medicaid programs.

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

    Comments: HHS concurred with this recommendation. CMS has signed an Interagency Agreement that provides for the states' ability to access the SSA Death Master File. CMS said that it will provide Death Master File information to specific individuals within each state in the near future. To close the recommendation, CMS will need to begin to provide the states with access to Death Master File data and provide us with documentation that it has done so.
    Recommendation: To improve the effectiveness of states' and plans' MMC plan provider screening efforts, the Acting Administrator of CMS should coordinate with other federal agencies, as necessary, to explore the use of an identifier that is relevant for the screening of MMC plan providers and common across databases used to screen MMC plan providers.

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

    Comments: HHS concurred with the recommendation. We will update the status of this recommendation when we receive additional information.
    Director: Kay E. Brown
    Phone: (202) 512-7215

    1 open recommendations
    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 is working with the child advocate contractor to develop standard operating procedures (SOP) to assign child advocates for children as well as address issues identified in the report and monitor the referral and selection process. ORR also reported that its field staff are working with care providers to ensure that care providers are making referrals for child advocates where a local program exists. In July 2017, ORR reported that new SOPs are under development and the program continues to deny cases when child advocates are unavailable due to the limited number of child advocates. Finalizing standard operating procedures for program referrals and developing a process to review information on the children the program contractor determines it is unable to serve would be positive steps towards addressing the recommendation.
    Director: Kathleen M. King
    Phone: (202) 512-7114

    2 open recommendations
    including 2 priority recommendations
    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 May 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. 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: In order to ensure that CMS has the information it needs to evaluate MAC effectiveness in preventing improper payments and to evaluate and compare contractor performance across its Medicare claim review program, CMS should provide the MACs with written guidance on how to accurately calculate and report savings from prepayment claim reviews.

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

    Comments: In May 2016, we recommended that the Centers for Medicare and Medicaid Services (CMS) should provide the Medicare Administrative Contractors (MACs) with written guidance on how to accurately calculate and report savings from prepayment claim reviews. HHS concurred with this recommendation and stated that it will develop a uniform method to calculate savings from prepayment claim reviews and issue guidance to the MACs. According to CMS, as of April 2017, the agency is in the process of developing a methodology for the MACs to use to estimate the amount that CMS would have paid providers had their claims not been denied. We will assess HHS's actions once we can review any guidance provided to the MACs.
    Director: James Cosgrove
    Phone: (202) 512-7114

    2 open recommendations
    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 July 2016, the U.S. Department of Health and Human Services (HHS) reiterated its disagreement with our recommendation. HHS stated that the Centers for Medicare & Medicaid Services (CMS) uses Medicare fee-or-service(FFS) spending rates when setting the benchmark, which excludes services provided by Department of Veterans Affairs (VA) facilities. In addition, HHS stated that incorporating VA utilization and diagnosis data into CMS's analysis may not materially improve the analysis and the resulting adjustment. HHS indicated that it will continue to review the need for incorporating additional data or for methodology changes in the future. As we note in the report, only VA's utilization and diagnosis data can account for services provided by and diagnoses made by VA. Depending on the number and mix of services provided by and the diagnoses made by VA, risk-adjusted Medicare FFS spending for veterans may either be higher or lower than it would be if CMS accounted for VA-provided services and diagnoses. Therefore, relying exclusively on Medicare FFS spending to estimate the effect of VA spending on Medicare FFS-enrolled veterans could result in an inaccurate estimate of how VA spending on services for Medicare FFS-enrolled veterans affects per capita county Medicare FFS spending. While there may be challenges associated with incorporating VA utilization and diagnosis data into CMS's analysis, we maintain that CMS should work to do so given the implications that not incorporating the data may have on the accuracy of payment to MA plans.
    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: The Department of Health and Human Services (HHS)has proposed adjusting the benchmark for 2017 to account for the Department of Veterans Affairs (VA) spending on Medicare-covered services. As of July 2016, HHS had not yet completed its assessment of whether an additional adjustment to MA payments is needed to ensure that payment to Medicare Advantage (MA) plans are equitable for veterans and nonveterans. In order to close this recommendation, CMS will need to complete its assessment.
    Director: Carolyn L. Yocom
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To ensure the appropriate level of Medicaid program integrity oversight in the territories, the Acting Administrator of CMS should reexamine CMS's program integrity strategy and develop a cost-effective approach to enhancing Medicaid program integrity in the territories. Such an approach could select from a broad array of activities, including--but not limited to--establishing program oversight mechanisms, such as requiring territories to establish a Medicaid Fraud Control Unit or working with them to obtain necessary exemptions or waivers from applicable program oversight requirements; assisting territories in improving their information on Medicaid and CHIP program spending; and conducting additional program assessments of program integrity as warranted.

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

    Comments: CMS has plans that may enhance Medicaid program integrity in the territories, but as of September, 2016, they have not yet been implemented. In May 2016, CMS notified all territories regarding the requirement to create a Medicaid Fraud Control Unit (MFCU) or seek a waiver of this requirement. As of September, 2016, according to CMS, Puerto Rico has indicated interest in establishing a MFCU, American Samoa and Guam have requested a waiver to the MFCU requirement, the Commonwealth of the Northern Mariana Islands has indicated interest in seeking a waiver, and the agency is working with the United States Virgin Islands regarding its response to this requirement. CMS intends to conduct comprehensive reviews of program integrity activities in the territories during fiscal year 2017, which have the potential to strengthen program integrity. Although these planned activities have the potential to strengthen program oversight, they have not yet been implemented. As of September 2016, no territory has established a MFCU or been granted a waiver to this requirement and comprehensive program integrity reviews will not occur until fiscal year 2017.
    Director: James Cosgrove
    Phone: (202) 512-7114

    5 open recommendations
    including 1 priority recommendation
    Recommendation: As CMS continues to implement and refine the contract-level RADV audit process to improve the efficiency and effectiveness of reducing and recovering improper payments and to improve the accuracy of CMS's calculation of coding intensity, the Administrator should modify that calculation by taking actions such as the following: (1) including only the three most recent pair-years of risk score data for all contracts; (2) standardizing the changes in disease risk scores to account for the expected increase in risk scores for all MA contracts; (3) developing a method of accounting for diagnostic errors not coded by providers, such as requiring that diagnoses added by MA organizations be flagged as supplemental diagnoses in the agency's Encounter Data System to separately calculate coding intensity scores related only to diagnoses that were added through MA organizations' supplemental record review (that is, were not coded by providers); and (4) including MA beneficiaries enrolled in contracts that were renewed from a different contract under the same MA organization during the pair-year period.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: As CMS continues to implement and refine the contract-level RADV audit process to improve the efficiency and effectiveness of reducing and recovering improper payments. The Administrator should modify CMS's selection of contracts for contract-level RADV audits to focus on those contracts most likely to have high rates of improper payments by taking actions such as the following: (1) selecting more contracts with the highest coding intensity scores; (2) excluding contracts with low coding intensity scores; (3) selecting contracts with high rates of unsupported diagnoses in prior contract-level RADV audits; (4) if a contract with a high rate of unsupported diagnoses is no longer in operation, selecting a contract under the same MA organization that includes the service area of the prior contract; and (5) selecting some contracts with high enrollment that also have either high rates of unsupported diagnoses in prior contract-level RADV audits or high coding intensity scores.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: As CMS continues to implement and refine the contract-level RADV audit process to improve the efficiency and effectiveness of reducing and recovering improper payments. The Administrator should enhance the timeliness of CMS's contract-level RADV process by taking actions such as the following: (1) closely aligning the time frames in CMS's contract-level RADV audits with those of the national RADV audits the agency uses to estimate the MA improper payment rate; (2) reducing the time between notifying MA organizations of contract audit selection and notifying them about the beneficiaries and diagnoses that will be audited; (3) improving the reliability and performance of the agency's process for transferring medical records from MA organizations, including assessing the feasibility of updating Electronic Submission of Medical Documentation for use in transferring medical records in contract-level RADV audits; and (4) requiring that CMS contract-level RADV auditors complete their medical record reviews within a specific number of days comparable to other medical record review time frames in the Medicare program.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: As CMS continues to implement and refine the contract-level RADV audit process to improve the efficiency and effectiveness of reducing and recovering improper payments. The Administrator should improve the timeliness of CMS's contract-level RADV appeal process by requiring that reconsideration decisions be rendered within a specified number of days comparable to other medical record review and first-level appeal time frames in the Medicare program.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: As CMS continues to implement and refine the contract-level RADV audit process to improve the efficiency and effectiveness of reducing and recovering improper payments. The Administrator should ensure that CMS develops specific plans and a timetable for incorporating a RAC in the MA program as mandated by the Patient Protection and Affordable Care Act.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: David A. Powner
    Phone: (202) 512-9286

    1 open recommendations
    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: We are following up with HHS on their service level agreement (SLA) guidance.
    Director: Kathleen King
    Phone: (202) 512-7114

    1 open recommendations
    including 1 priority recommendation
    Recommendation: To help ensure that timely primary care is available and accessible to AI/AN people, the Secretary of HHS should direct the Director of IHS to monitor patient wait times in its federally operated facilities and ensure corrective actions are taken when standards are not met.

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

    Comments: As of June 2017, according to IHS, the implementation of an agency-wide standard for patient wait times will be accomplished as follows: A decision will be made on the standard to be used, by the IHS Director no later than July 2017. Using a pilot sample of facilities (two to four facilities), the standard will be assigned to the Area Directors over the selected pilot facilities in October 2017. Systems of measurement will be decided and communicated to the Area Directors for the pilot facilities. By December 31, 2017, three months of activity will be analyzed and evaluated against the standard. Between January and March, 2018, adjustments to the necessary systems of measure, or adjustments to the reasonably expected performance standard will be made. A final evaluation will be performed not later than September 2018, and final adjustments will be made to either the measurement system or the standard to allow for full implementation of the standard across all IHS Areas by October, 2018.
    Director: Gregory C. Wilshusen
    Phone: (202) 512-6244

    2 open recommendations
    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 stated that it plans to implement it. Subsequent to the agency informing us that it has taken action, we plan 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 stated that it plans to implement it. Subsequent to the agency informing us that it has taken action, we plan to verify whether implementation has occurred.
    Director: Marcia Crosse
    Phone: (202) 512-7114

    5 open recommendations
    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. CDC did not provide an anticipated completion date. FDA anticipated completing the policy revisions/updates by summer 2018.
    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.
    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.
    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 FDA is working to establish a process for notifying senior agency officials of inspection results, and in August 2017, FDA reported that it was in the process of updating its policies to reflect such a notification process. FDA anticipated that the updated policies and processes would be in place by summer 2018. 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.
    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 is 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.
    Director: Linda Kohn
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: To enhance its stewardship of clinical trials across the ICs, the Secretary of the Department of Health and Human Services (HHS) should direct the NIH OD to finalize data on clinical trial activity that the OD needs to collect from ICs.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS concurred with this recommendation and stated that the agency plans to complete its efforts to identify additional data that will be collected from the ICs on a regular basis. HHS indicated that these data will provide the OD with readily available information on the number, type, and progress of clinical trials funded across the ICs. HHS stated that a working group of NIH staff with expertise in clinical trials has been assembled to begin developing specific requirements for the enterprise-wide system for clinical trial management and oversight.
    Recommendation: To enhance its stewardship of clinical trials across the ICs, the Secretary of HHS should direct the NIH OD to establish and implement a process for using those data.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS concurred with this recommendation and stated that the agency plans to complete its efforts to identify additional data that will be collected from the ICs on a regular basis. HHS indicated that these data will provide the OD with readily available information on the number, type, and progress of clinical trials funded across the ICs. HHS stated that a working group of NIH staff with expertise in clinical trials has been assembled to begin developing specific requirements for the enterprise-wide system for clinical trial management and oversight, and that the system will be used by NIH OD and the NIH ICs to meet stewardship responsibilities and for strategic planning and priority setting.
    Director: David Powner
    Phone: (202) 512-9286

    1 open recommendations
    Recommendation: The Secretaries of the Departments of Agriculture, Commerce, Defense, Education, Energy, Health and Human Services, Homeland Security, Housing and Urban Development, the Interior, Labor, State, Transportation, the Treasury, and Veterans Affairs; the Attorney General of the United States; the Administrators of the Environmental Protection Agency, General Services Administration, National Aeronautics and Space Administration, and U.S. Agency for International Development; the Director of the Office of Personnel Management; the Chairman of the Nuclear Regulatory Commission; and the Commissioner of the Social Security Administration should take action to improve progress in the data center optimization areas that we reported as not meeting OMB's established targets, including addressing any identified challenges.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: The Department of Health and Human Services agreed with our recommendation, and has taken initial steps to implement it. In May 2016, the department stated in correspondence to GAO that it would work to improve the data center optimization metrics that did not meet the Office of Management and Budget's (OMB) established targets. The department further stated that it expected to have a more detailed approach available through a Data Center Strategy, which was expected before the end of fiscal year 2016 . However, as of July 2017, the department reports on OMB's IT Dashboard that it meets only one (power usage efficiency) of the five data center optimization metric targets OMB currently requires agencies to report against. The department further reports that it does not meet the remaining four targets (related to server utilization and monitoring, energy metering, server virtualization, and data center facility space). We will continue to monitor and evaluate the department's progress in implementing this recommendation.
    Director: Seto J. Bagdoyan
    Phone: (202) 512-6722

    8 open recommendations
    including 8 priority recommendations
    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 conduct a comprehensive feasibility study on actions that CMS can take to monitor and analyze, both quantitatively and qualitatively, the extent to which data hub queries provide requested or relevant applicant verification information, for the purpose of improving the data-matching process and reducing the number of applicant inconsistencies; and for those actions identified as feasible, create a written plan and schedule for implementing 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 it was reviewing options for conducting a feasibility study to monitor and analyze information received from the Hub as recommended. HHS plans to examine the hub process in delivering usable information for applicant verification and analyzing data to identify trends or patterns that could suggest improvements in verification or actions that could reduce the number of inconsistencies that require further attention. HHS reported that this effort began March 2016. In March 2017, the agency said it is making significant progress towards implementing the recommendation. We will continue to monitor HHS'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 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. Once received, we will review to determine whether the efforts taken warrant closing the recommendation. In March 2017, HHS provided us information on their response to this and other recommendations from this report. However, HHS has not provided sufficient documentation to show that they have implemented this recommendation. 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, 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
    Priority recommendation

    Comments: In April 2016, HHS reported it considers this recommendation closed because CMS has considered whether it would be feasible to create a mechanism to recapture CSRs and determined that this is not possible under the current statute. HHS also noted that as currently written, the statute does not provide this authority and to pursue developing a mechanism to do so would require Congress to change the statute. In May 2016, we agreed to consider the recommendation closed upon HHS advising us if it made any review or inquiry into the feasibility of recapture apart from statutory authority and providing documentation of such consideration so that we have a full record of the agency's consideration prior to closing the recommendation. In March 2017, HHS provided us information on their response to this and other recommendations from this report. However, HHS has not provided sufficient documentation to show that they have implemented this recommendation. 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 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. In March 2017, HHS provided us information on their response to this and other recommendations from this report. However, HHS has not provided sufficient documentation to show that they have implemented this recommendation. 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. Once received, we will review to determine whether the efforts taken warrant closing the recommendation. In March 2017, HHS provided us information on their response to this and other recommendations from this report. However, HHS has not provided sufficient documentation to show that they have implemented this recommendation. 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 it considers this recommendation closed because since May 2015, call center representatives have received daily updates on the status of eligibility documentation. It is working to provide call center representatives with real-time data that is tentatively scheduled for later in 2016. In May 2016, we noted that our 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. Once received, we will review to determine whether the efforts taken warrant closing the recommendation. In March 2017, HHS provided us information on their response to this and other recommendations from this report. However, HHS has not provided sufficient documentation to show that they have implemented this recommendation. 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 conduct a fraud risk assessment, consistent with best practices provided in GAO's framework for managing fraud risks in federal programs, of the potential for fraud in the process of applying for qualified health plans through the federal Marketplace.

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

    Comments: In April 2016, HHS reported that it considered this recommendation open. It noted that CMS has launched a Marketplace Integrated Project Team (IPT) through the Program Integrity Board, which includes senior staff from across CMS. An objective of the IPT is to complete the fraud risk assessment of Marketplace eligibility and enrollment based on GAO's Fraud Risk Framework, as required by the recommendation. HHS said the first three steps of GAO's framework for this part were to be completed by early summer. Once HHS has completed all relevant steps of the framework, and the agency has fully documented its implementation efforts-including discussion of any items contemplated by the framework that HHS elected not to follow-we will review to determine whether the efforts taken warrant closing the recommendation. In March 2017, HHS provided us information on their response to this and other recommendations from this report. However, HHS has not provided sufficient documentation to show that they have implemented this recommendation. 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. In March 2017, HHS provided us information on their response to this and other recommendations from this report. However, HHS has not provided sufficient documentation to show that they have implemented this recommendation. We will continue to monitor the agency's progress in this area.
    Director: Katherine Iritani
    Phone: (202) 512-7114

    2 open recommendations
    including 2 priority recommendations
    Recommendation: To promote consistency in the distribution of supplemental payments among states and with CMS policy, the Administrator of CMS should issue written guidance clarifying its policy that requires a link between the distribution of supplemental payments and the provision of Medicaid-covered services.

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

    Comments: CMS plans to publish a proposed rule for public comment in the summer of 2017 to improve the oversight of supplemental payments, including a proposal to require that supplemental payments be distributed proportional to the volume or cost of services delivered or be tied to meeting performance benchmarks. To the extent the agency issues a final rule that results in states distributing supplemental payments in a manner that aligns their distribution with individual facilities' Medicaid workloads, CMS's ability to ensure that state Medicaid payments are not excessive and are used for Medicaid purposes will improve.
    Recommendation: To promote consistency in the distribution of supplemental payments among states and with CMS policy, the Administrator of CMS should issue written guidance clarifying its policy that payments should not be made contingent on the availability of local funding.

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

    Comments: CMS plans to publish a proposed rule for public comment in the summer of 2017 to improve the oversight of supplemental payments, including a proposal to require that supplemental payments be distributed proportional to the volume or cost of services delivered or be tied to meeting performance benchmarksTo the extent the agency issues a final rule that results in states distributing supplemental payments in a manner that aligns their distribution with individual facilities' Medicaid workloads, CMS's ability to ensure that state Medicaid payments are not excessive and are used for Medicaid purposes will improve.
    Director: Kay E. Brown
    Phone: (202) 512-7215

    3 open recommendations
    including 1 priority recommendation
    Recommendation: The Secretary of the Department of Health and Human Services should direct the Office of Refugee Resettlement to develop a process to update its bed capacity framework on an annual basis to include the most recent data related to numbers of unaccompanied children who may be referred to its care and adjust its planning scenarios that guide its bed capacity as appropriate.

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

    Comments: The Office of Refugee Resettlement (ORR) developed a bed capacity framework for fiscal year 2016 and anticipated completing its fiscal year 2017 bed capacity framework by September 30, 2016. The framework includes bed capacity projections, including expected referrals and placement needs, based, in part, on data from the previous year. GAO will close this recommendation when HHS completes its 2017 bed capacity framework.
    Recommendation: The Secretary of the Department of Health and Human Services should direct the Office of Refugee Resettlement to review its monitoring program to ensure that onsite visits are conducted in a timely manner, case files are systematically reviewed as part of or separate from onsite visits, and that grantees properly document the services they provide to children.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS agreed with our recommendation and ORR is in the process of reviewing its monitoring templates and tools and, according to HHS, has conducted a monitoring training for its Project Officers. In addition, ORR is sending additional Project Officers into the field to complete scheduled monitoring visits to its care provider facilities. HHS reports that ORR is on track to complete all scheduled monitoring visits for FY 2016. We will close this recommendation when ORR has completed its review of its monitoring templates and tools and demonstrates that it can complete its planned monitoring visits on schedule.
    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: The Office of Refugee Resettlement (ORR) created a new section in its unaccompanied children's policy guide that, among other things, includes case reporting, records management, retention, and information sharing requirements for post-release service providers. Post-release service providers are required to maintain this information in an ORR-provided database. Also, the section requires that all reports made to ORR's National Call Center be documented and reported in accordance with mandatory reporting laws, state licensing requirements, federal laws and regulations, and ORR policies and procedures. Lastly, in May 2016, ORR released data for the first quarter of fiscal year 2016 on Safety and Well-Being (SWB) follow-up calls that were made to children and their sponsors.
    Director: Carolyn L. Yocom
    Phone: (202) 512-7114

    1 open recommendations
    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: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: John Neumann
    Phone: (202) 512-3841

    1 open recommendations
    Recommendation: The Secretaries of Energy, Defense, and Health and Human Services should develop detailed guidance to ensure that ORISE program coordinators, mentors, and research participants are fully informed of the prohibition on nonfederal employees performing inherently governmental functions.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS had not provided information as of July 2017 on steps it has taken to address the recommendation.
    Director: Kathleen M. King
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: To strengthen oversight of the provision of care coordination services in the Financial Alignment Demonstration, the Secretary of Health and Human Services should direct the Administrator of CMS to expediently develop and require organizations in the capitated model, and the states in the MFFS model, to report comparable core data measures across the demonstration that measure the following: (1) the extent to which interdisciplinary care team meetings are occurring, and (2) for MFFS states, the extent to which health risk assessments are completed.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In April 2016, CMS officials told us they are exploring whether it would be feasible to identify and develop additional measures related to interdisciplinary care team meetings and health risk assessment completion within the demonstration period. For the first part of our recommendation, CMS officials said that they did not believe it was feasible to implement a care team measure during the demonstration period. For the second part of our recommendation, CMS officials said they had begun discussions with their existing CMS contractor about the level of effort required to develop and implement a health risk assessment measure in the Managed-Fee-For-Service (MFFS) demonstrations. CMS also planned to have discussions with the MFFS model states about the feasibility of collecting and reporting this type of data. As of June 2017, 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 strengthen oversight of the provision of care coordination services in the Financial Alignment Demonstration, the Secretary of Health and Human Services should direct the Administrator of CMS to align CMS's existing state-specific measures regarding the extent to which individualized care plans are being developed across the capitated and MFFS states to make them comparable and designate them as a core reporting requirement.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In April 2016, CMS officials said they planned to use an existing CMS contractor to develop a care plan measure that more closely aligns the specifications across demonstrations. As of June 2017, 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.
    Director: Valerie Melvin
    Phone: (202) 512-6304

    2 open recommendations
    Recommendation: To help ensure that FDA's IT strategic planning activities are successful in supporting the agency's mission, goals, and objectives, the Commissioner of FDA should require the CIO to establish schedules and milestones for completing a version of an IT strategic plan that incorporates elements to align the plan's strategies with agency-wide priorities; includes results-oriented goals and performance measures that support the agency's mission, along with targets for measuring the extent to which outcomes of IT initiatives support FDA's ability to achieve agency-wide goals and objectives; identifies key IT initiatives that support the agency's goals; and describes interdependencies among the initiatives.

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

    Comments: FDA concurred with the recommendation and stated that the agency plans to implement it. We contacted the agency in March 2017 and have requested documents regarding FDA's actions to address the recommendation. We are waiting to receive the documents. We will update the status of the agency's actions after we receive and evaluate their response.
    Recommendation: To help ensure that FDA's IT strategic planning activities are successful in supporting the agency's mission, goals, and objectives, the Commissioner of FDA should require the CIO to implement the plan to ensure that expected outcomes of the agency's key IT initiatives are achieved.

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

    Comments: FDA concurred with the recommendation and stated that the agency plans to implement it. We contacted the agency in March 2017 and have requested documents regarding FDA's actions to address the recommendation. We are waiting to receive the documents. We will update the status of the agency's actions after we receive and evaluate their response.
    Director: Marcia Crosse
    Phone: (202) 512-7114

    2 open recommendations
    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 develop comprehensive plans, with goals and time frames, to help ensure that identified problems with the completeness, timeliness, and accuracy of information in its database on tracked safety issues and postmarket studies are corrected.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: FDA has started taking steps to help ensure that identified problems with its data on tracked safety issues and postmarket studies are corrected. For example, FDA plans to conduct an assessment of tracked safety data by 2022 and is developing a quality measurement plan that will include periodic audits of postmarket study data. However, as of August 2017, FDA has not provided specifics regarding what types of actions it will take once these assessments and audits are completed, including goals and time frames for when these actions will be completed. GAO is keeping this recommendation open until FDA provides information on how it will address issues identified in its assessments and audits and the time frames for doing so.
    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 identified actions that could potentially improve FDA's process for overseeing tracked safety issues, but as of August 2017, FDA has not indicated that stakeholder input has been solicited specifically regarding improvements to FDA's IT systems that would facilitate systematic oversight of these issues. FDA may address this as part of a planned assessment of its data system that is not scheduled to be completed until FY 2022. For postmarket studies, FDA has indicated that it intends to formally assess the IT needs of users once it has transferred postmarket data to its new informatics platform, which will not occur until 2018 at the earliest. GAO is keeping this recommendation open until FDA has worked with stakeholders to identify improvements to FDA's IT systems to capture information in a form that can be used by staff for oversight purposes.
    Director: Kathleen M. King
    Phone: (202) 512-7114

    1 open recommendations
    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.
    Director: Melissa Emrey-Arras
    Phone: (617) 788-0534

    1 open recommendations
    Recommendation: To comply with Title IX enforcement requirements, the Secretary of the Department of Health and Human Services, which funds STEM research at universities, should ensure that Title IX compliance reviews of NIH's grantees are periodically conducted.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS indicated it would consult with NIH and initiate a sex discrimination compliance review program that includes grantee institutions with STEM programs. We will update the status of this recommendation when the agency provides documentation that these efforts have been completed.
    Director: Gregory C. Wilshusen
    Phone: (202) 512-6244

    1 open recommendations
    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 Departments of Agriculture and Health and Human Services released an update to the food and agriculture sector-specific plan for 2015. The plan states the sector's lack of an overarching mechanism to measure and evaluate risk mitigation activities and the challenge of obtaining performance measurement data from non-federal partners. However, the plan notes a goal of evaluating the progress of individual protective programs and strategies. No metrics or reports of outcomes have been provided to address the challenge of monitoring the sector's cybersecurity progress. We will continue to follow up to determine whether HHS has developed and implemented mechanisms to measure the outcomes of its sector cybersecurity-related activities.
    Director: Linda Kohn
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: To improve the measurement of nursing home quality, the Administrator of CMS should establish specific timeframes, including milestones to track progress, for the development and implementation of a standardized survey methodology across all states.

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

    Comments: HHS concurred with this recommendation and in September 2017 reported that CMS is taking steps to address. We will update the status of this recommendation when we receive additional information.
    Recommendation: To improve the measurement of nursing home quality, the Administrator of CMS should establish and implement a clear plan for ongoing auditing to ensure reliability of data self-reported by nursing homes, including payroll-based staffing data and data used to calculate clinical quality measures.

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

    Comments: HHS concurred with this recommendation and in September 2017 reported that CMS is taking steps to address. We will update the status of this recommendation when we receive additional information.
    Recommendation: To help ensure modifications of CMS's oversight activities do not adversely affect the agency's ability to assess nursing home quality and that effective modifications are adopted more widely, the Administrator of CMS should establish a process for monitoring modifications of essential oversight activities made at the CMS central office, CMS regional office, and state survey agency levels to better understand the effects on nursing home quality oversight.

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

    Comments: HHS concurred with this recommendation and in September 2017 reported that CMS is taking steps to address. We will update the status of this recommendation when we receive additional information.
    Director: Linda Kohn
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: To ensure effective implementation of the Inclusion Policy in a manner consistent with the Revitalization Act's provisions regarding the design of certain clinical trials, the NIH Director should examine approaches for aggregating more detailed enrollment data at the disease and condition level, and report on the status of this examination to key stakeholders and through its regular biennial report to Congress on the inclusion of women in research.

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

    Comments: NIH agreed with our recommendation and began discussions in November 2015 regarding conducting these types of analyses. In April and May 2016, NIH officials identified a preliminary strategy for summarizing inclusion data at the disease and condition level. As of August 2017, NIH officials said that due to potential data limitations, NIH will continue to refine methods of reporting at this level, and the agency plans to report enrollment data at the disease and condition level in its next triennial NIH report to Congress, covering fiscal years 2015-2017, to be drafted in fiscal year 2018.
    Recommendation: To ensure effective implementation of the Inclusion Policy in a manner consistent with the Revitalization Act's provisions regarding the design of certain clinical trials, the NIH Director should, on a regular basis, systematically collect and analyze summary data regarding awardees' plans to conduct analyses of potential sex differences, such as the proportion of trials being conducted that intend to analyze differences in outcomes for men and women.

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

    Comments: In August 2017, NIH reiterated that the agency has established a number of policies and processes to ensure that sex differences are considered in the design of research, but has not taken action specific to this recommendation. We continue to believe that thoughtful, useful analysis and summary reporting would improve NIH's oversight of this aspect of the Inclusion Policy.
    Recommendation: To ensure effective implementation of the Inclusion Policy in a manner consistent with the Revitalization Act's provisions regarding the design of certain clinical trials, the NIH Director should report on this summary data and the results of this analysis in NIH's regular biennial report to Congress on the inclusion of women in research.

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

    Comments: NIH agreed with our recommendation in commenting on our report. In August 2017, NIH reiterated that the agency has established a number of policies and processes to ensure that sex differences are considered in the design of research, but has not taken action specific to this recommendation. We continue to believe that thoughtful, useful analysis and summary reporting would improve NIH's oversight of this aspect of the Inclusion Policy.
    Director: Carolyn L. Yocom
    Phone: (202) 512-7114

    2 open recommendations
    including 2 priority recommendations
    Recommendation: To improve the effectiveness of its oversight of eligibility determinations, the Administrator of CMS should conduct reviews of federal Medicaid eligibility determinations to ascertain the accuracy of these determinations and institute corrective action plans where necessary.

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

    Comments: The Department of Health and Human Services (HHS) has taken some steps to improve the accuracy of Medicaid eligibility determinations, as GAO recommended in October 2015, but has not conducted a systematic review of federal eligibility determinations. In March 2017, HHS reported that it is reviewing federal determinations of Medicaid eligibility in two of the nine states that have delegated eligibility determination authority to the federal marketplace and HHS is planning to include reviews of federal determinations as part of its future Payment Error Rate Measurement (PERM) reviews, which will resume in 2018 pending final publication of the proposed PERM rule (81 FR 40596). In October 2016, HHS officials provided information indicating that the Department is relying upon operational controls within federally marketplaces to ensure accurate eligibility determinations as well as new processes that would identify duplicate coverage. These actions have value, however, they are not sufficient to identify other types of erroneous eligibility determinations. Without a systematic review of federal eligibility determinations, HHS lacks a mechanism to identify and correct errors and associated payments.
    Recommendation: To increase assurances that states receive an appropriate amount of federal matching funds, the Administrator of CMS should use the information obtained from state and federal eligibility reviews to inform the agency's review of expenditures for different eligibility groups in order to ensure that expenditures are reported correctly and matched appropriately.

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

    Comments: As of October 2016, HHS is establishing a process to make the eligibilty and expenditure reviews interact with one another. GAO will work with the agency to determine if these actions address the recommendation.
    Director: James Cosgrove
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: To determine the extent to which Medicare payments are aligned with costs for specific types of dialysis treatment and training, the Administrator of CMS should take steps to improve the reliability of the cost report data for treatment and training associated with specific types of dialysis.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Administrator of CMS should examine Medicare policies for monthly payments to physicians to manage the care of dialysis patients and revise them if necessary to ensure that these policies are consistent with CMS's goal of encouraging the use of home dialysis among patients for whom it is appropriate.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To ensure that patients with chronic kidney disease receive objective and timely education related to this condition, the Administrator of CMS should examine the Kidney Disease Education benefit and, if appropriate, seek legislation to revise the categories of providers and patients eligible for the benefit.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Carolyn L. Yocom
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To better minimize the risk of coverage gaps and duplicate coverage for individuals transitioning between Medicaid and the exchange in FFE states, the Administrator of CMS should routinely monitor the timeliness of account transfers from state Medicaid programs to CMS and identify alternative procedures if near real time transfers are not feasible in a state.

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

    Comments: As of June 2017, CMS had taken a number of steps to improve the timeliness of account transfers. In June 2016, CMS conducted a webinar for states setting forth that best practices for account transfers was that they happen real time or, at a minimum, in daily batches. In July 2016, CMS issued guidance to states reiterating the requirement that states transfer accounts to CMS promptly and providing examples of ways for states to streamline that process. In June 2017, CMS reported that they have developed standard reports for reviewing errors in account transfers and those reports are being reviewed on a weekly basis. However, CMS reported that it does not have access to data on how promptly states are transferring accounts outside of limited survey data from 8 states that indicate that some transfers are occurring real-time while others are being transferred daily or weekly. We will continue to monitor CMS's progress and will close the recommendation when CMS has a greater understanding of how many states are transferring data in accordance with CMS guidance on the timeliness of transfers.
    Director: J. Alfredo Gómez
    Phone: (202) 512-3841

    1 open recommendations
    Recommendation: To enhance HHS's ability to protect public health from the impacts of climate change, the Secretary of HHS should direct CDC to develop a plan describing when it will be able to issue climate change communication guidance to state and local health departments, to better position relevant officials to effectively communicate about the risks that climate change poses to public health and address requirements of the Climate Ready States and Cities Initiative.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of December 2016, CDC has taken steps to start developing a communications strategy, and expects this process to include the development of guidance for public health officials to help them more effectively communicate about the health effects of climate change. CDC expects the strategy to be completed by the fall of 2017.
    Director: Steve D. Morris
    Phone: (202) 512-3841

    3 open recommendations
    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 modify the voluntary reporting form FDA uses to obtain information on adverse events to ask whether drugs involved in adverse events were compounded.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of July 2017, FDA has drafted a notice for publication in the Federal Register that seeks comment on editorial revisions to Form FDA 1932a to clarify how to report adverse drug events associated with compounded products using that form. The publication of the notice was issued in July 2017. After a 60-day public comment period, the revisions to Form FDA 1932a will be submitted to OMB for review and approval under the Paperwork Reduction Act.
    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 July 2017, FDA notified us that they are still in the process of developing guidance for agency staff that specifies circumstances under which FDA will enforce compounding regulations for animals. According to FDA, the agency received more than 150 comments regarding the draft Guide For Industry #230 and 280 nominations of bulk drug substances for use in compounding office stock; information necessary for updating the guidance. In addition, FDA is reviewing the substances that were nominated for use in compounding office stock. Officials did not provide a specific timeline for completing this work, but stated that developing updated guidance on compounding for animals continues to be a high priority for FDA.
    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: As of July 2017, FDA reported that it is still developing an enforcement strategy for compounded animal drugs that includes a process for documenting the Agency's actions with respect to follow-up on warning letters, adverse event reports, and complaints.
    Director: Valerie C. Melvin
    Phone: (202) 512-6304

    2 open recommendations
    Recommendation: To improve the oversight of states' marketplace IT projects, the Secretary of Health and Human Services should direct the Administrator of the Centers for Medicare & Medicaid Services to ensure that all CMS senior executives from IT and business units who are involved in the establishment of state marketplace IT projects review and approve funding decisions for these projects.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In 2015, Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) concurred with the recommendation. The department, in its agency comments, stated that it already included senior executives in its funding decisions for these projects. However, as noted in our report, CMS did not provide evidence that key senior executives from CCIIO, CMCS, and OTS were involved in various funding decisions associated with the states' IT projects. For example, CMS did not demonstrate that senior-level executives from all relevant business and IT units were involved in the initial approval of grant awards or the release of restricted IT funds from marketplace grants as states progressed with their projects. In addition, CMS did not provide evidence of senior executive involvement in the approval of Medicaid funds for marketplace IT projects. Furthermore, as of March 10, 2017, CMS still had not provided evidence that it had taken such actions to support the implementation of this recommendation. By ensuring such executive involvement, CMS would increase accountability for decisions to fund states' IT projects and ensure that these decisions are well informed in order to make efficient use of federal funds.
    Recommendation: To improve the oversight of states' marketplace IT projects, the Secretary of Health and Human Services should direct the Administrator of the Centers for Medicare & Medicaid Services to ensure that states have completed all testing of marketplace system functions prior to releasing them into operation.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In 2015, Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) concurred with the recommendation. The department noted that it would continue to follow its guidelines to determine if state marketplace system functions are ready for release. The department added that it would work closely with state-based marketplaces to improve their systems and verify that system requirements are met and fully tested before approving them for release into production. While CMS drafted guidance to update its process in June 2016, which required states to submit certain testing reports and supporting documentation, as of March 10, 2017, the agency had not provided evidence that it had determined that state systems had been sufficiently tested for release into operations.
    Director: David Powner
    Phone: (202) 512-9286

    1 open recommendations
    Recommendation: To improve the department's IT savings reinvestment plans, the Secretary of Health and Human Services should direct the CIO, as part of any future update to the department's IRM strategic plan or equivalent document, to include information regarding the approach to reinvesting savings from the consolidation of commodity IT resources (including data centers) in accordance with OMB's guidance.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: The Department of Health and Human Services (HHS) agreed with, and has taken initial steps to implement, our recommendation. Specifically, in November 2015, the department stated that its Office of the Chief Information Officer will include reinvestment strategies in its next update of the HHS Information Resource Management Strategic Plan. According to the department, the updated strategic plan was expected to be completed by the end of September 2016. However, as of May 2017, the agency had not yet updated its Information Resources Management Strategic Plan to include information regarding the approach to reinvesting savings from the consolidation of commodity IT resources. We will continue to evaluate the department's progress in implementing this recommendation.
    Director: James Cosgrove
    Phone: (202) 512-7114

    4 open recommendations
    Recommendation: To improve its oversight of network adequacy in MA, the Administrator of CMS should augment MA network adequacy criteria to address provider availability.

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

    Comments: HHS concurred with this recommendation, and noted in a January 2016 update that CMS will review how to augment the MA network adequacy criteria to address provider availability in future years. As of September 2016, agency officials have not implemented this recommendation.
    Recommendation: To improve its oversight of network adequacy in MA, the Administrator of CMS should verify provider information submitted by MAOs to ensure validity of the Health Services Delivery data.

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

    Comments: HHS concurred with this recommendation, and noted in a January 2016 update that the agency is working to standardize existing protocols to ensure the validity of the Health Services Delivery data submitted by MAOs with regards to exceptions requests and partial county justifications. However, unless CMS verifies provider information submitted by MAOs, the agency cannot be confident that MAOs are meeting network adequacy criteria. As of September 2016, agency officials have not implemented this recommendation.
    Recommendation: To improve its oversight of network adequacy in MA, the Administrator of CMS should expand network adequacy reviews by requiring that all MAOs periodically submit their networks for assessment against current Medicare requirements.

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

    Comments: HHS concurred with this recommendation. In a January 2016 update, the agency noted that CMS has expanded its reviews to include both existing and new service areas for network adequacy when MAOs apply for a service area expansion, However, unless CMS periodically requires evidence of compliance of all existing MAO networks, the agency cannot be confident that MAOs are meeting network adequacy criteria. As of September 2016, agency officials have not implemented this recommendation.
    Recommendation: To improve its oversight of network adequacy in MA, the Administrator of CMS should set minimum requirements for MAO letters notifying enrollees of provider terminations and require MAOs to submit sample letters to CMS for review.

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

    Comments: HHS concurred with this recommendation. In a January 2016 update, the agency noted that the Medicare Marketing Guidelines contain best practice suggestions of what should be included in the written termination notice; however, we note in our report those practices are not required, nor are the letters regularly reviewed. The agency also noted that it was considering rulemaking to require that MAOs submit sample written notices of termination to HHS for review and approval. As of September 2016, agency officials have not implemented this recommendation.
    Director: King, Kathleen M
    Phone: (202) 512-7114

    3 open recommendations
    including 3 priority recommendations
    Recommendation: As CMS prepares to solicit the next RAC contract(s), to improve the agency's RAC program operations and contractor oversight, the Administrator of CMS should ensure that work statements included in solicitations for contract proposals and the executed contract(s) set clear expectations about the work CMS intends the RAC to perform and that time frames are established that reflect the time needed to reach milestones.

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

    Comments: HHS agreed with our recommendation. As of March 2017, HHS stated that the agency was evaluating its strategy for the Medicare Part D RAC. Once HHS has completed its evaluation, we will update the status of these recommendations. As of May 2017, GAO considers this recommendation open.
    Recommendation: As CMS prepares to solicit the next RAC contract(s), to improve the agency's RAC program operations and contractor oversight, the Administrator of CMS should conduct annual evaluations of the RAC's performance against measurable performance standards to provide a clear basis on which CMS and the RAC can assess RAC performance in identifying improper payments.

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

    Comments: HHS agreed with our recommendations. As of March 2017, HHS stated that the agency was evaluating its strategy for the Medicare Part D RAC. Once HHS has completed its evaluation, we will update the status of these recommendations. As of May 2017, GAO considers this recommendation open.
    Recommendation: As CMS prepares to solicit the next RAC contract(s), to improve the agency's RAC program operations and contractor oversight, the Administrator of CMS should review the agency's process for identifying, reviewing, and approving new audit issues to identify process improvements that will help ensure the efficient development of appropriate audit issues (i.e., reduce audit issue denials and increase audit issue approvals) and thereby maximize the collection of improper payments.

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

    Comments: HHS agreed with our recommendations. As of March 2017, HHS stated that the agency was evaluating its strategy for the Medicare Part D RAC. Once HHS has completed its evaluation, we will update the status of these recommendations. As of May 2017, GAO considers this recommendation open.
    Director: Rebecca Gambler
    Phone: (202) 512-8777

    1 open recommendations
    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

    Comments: In September 2015, DHS stated that the department was collaborating with HHS on finalizing a Memorandum of Agreement (MOA) regarding UAC procedures. According to DHS, the MOA is meant to provide a framework for interagency coordination on the responsibilities of the parties in coordinating and establishing procedures, shared goals, and interagency cooperation with respect to UAC. In February 2016, DHS and HHS finalized the MOA. The MOA states that DHS and HHS agree to establish a Joint Concept of Operations (JCO) that should be completed no later than one year following the signing of the MOA. According to the MOA, the JCO should include, among other things, standard protocols for consistent interagency cooperation on the care, processing, and transport of UAC during both steady state operations, as well as in the event the number of UAC exceeds the standard capabilities of the departments to process, transport, and/or shelter with existing resources. As of August 2017, HHS told GAO that HHS and DHS are still in the process of drafting the JCO. To fully address the recommendation, DHS and HHS will need to ensure that the JCO, once finalized and implemented, includes 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.
    Director: William T. Woods
    Phone: (202) 512-4841

    3 open recommendations
    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 (HHS) has made progress towards addressing this recommendation. The Indian Health Service (IHS) is currently working on efforts to revise the Acquisition Management section of the Indian Health Manual to clarify and codify policies related to the priority for use of the Buy Indian Act. IHS plans for the revision to include implementation and reporting mechanisms for contracts awarded under the Buy Indian Act. HHS reported that IHS plans to issue new policy guidance relating to the Buy Indian Act and how it is to be implemented and prioritized in conjunction with other set asides.
    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: Officials at the Department of Health and Human Services' Indian Health Service (IHS) told us they plan to continue oversight to ensure that contractors comply with key requirements such as (1) maintaining the proportion of Indian ownership, (2) not subcontracting more than half the work to other than Indian firms, and (3) providing a preference to Indians in employment, training, and subcontracting. However, as of July 2017, IHS had not provided evidence that they were collecting data on regional offices' implementation of these key requirements. IHS officials told us they plan to incorporate Buy Indian Act policy language and clauses into all contracts and track Buy Indian award actions and obligations. IHS officials also stated they will ensure that the contracting officer authenticates an Indian Economic Enterprise's categorization/credentials, before award and throughout the contract period.
    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 include Buy Indian Act contracts as a part of their regular procurement review process.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: Department of Health and Human Services officials told us initial on-site communications to raise awareness of the Buy Indian Act was included in the fiscal year 2017 Indian Health Service (IHS) Procurement Management Reviews (PMR) being conducted at all area offices. Starting in the fall of 2017, IHS plans to develop webinar training sessions to ensure that a large, diverse audience of contracting and management officials have access to the training. IHS will also incorporate the Buy Indian Act Policy into the established annual procurement management reviews beginning in fiscal year 2018 to ensure compliance.
    Director: William T. Woods
    Phone: (202) 512-4841

    3 open recommendations
    Recommendation: To help ensure contracting officers follow ordering procedures when using FSS, and to enhance internal controls, the Secretaries of DOD and HHS and the Administrator of GSA should issue guidance emphasizing the requirement to seek discounts and outlining effective strategies for negotiating discounts when using the FSS program.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In December 2016, HHS stated that it had assessed and reviewed existing guidance and determined that existing guidance was adequate, but that HHS contracting officials needed to be refreshed on the content. While HHS stated that it had tasked the contracting heads of each HHS component with ensuring that its officials attend refresher training, the agency has not yet ensured that this has been accomplished. In June 2017, HHS officials said they were again considering issuing additional guidance, per our recommendation.
    Recommendation: To help ensure contracting officers follow ordering procedures when using FSS, and to enhance internal controls, the Secretaries of DOD and HHS and the Administrator of GSA should issue guidance reminding contracting officials of the procedures they must follow with respect to purchasing open market items through the FSS program, including the requirement to perform a separate determination that the prices of these items are fair and reasonable.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In December 2016, HHS stated that it had assessed and reviewed existing guidance and determined that existing guidance was adequate, but that HHS contracting officials needed to be refreshed on the content. While HHS stated that it had tasked the contracting heads of each HHS component with ensuring that its officials attend refresher training, the agency has not yet ensured that this has been accomplished. In June 2017, HHS officials said they were again considering issuing additional guidance, per our recommendation.
    Recommendation: To help foster competition for FSS orders consistent with the FAR, the Secretary of HHS should assess reasons that may be contributing to the high percentage of orders with one or two quotes--including the practice of narrowing the pool of potential vendors--and if necessary, depending on the results of the assessment, provide guidance to help ensure contracting officials are taking reasonable steps to obtain three or more quotes above the simplified acquisition threshold.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS agreed with the recommendation. In January 2017, an HHS official stated that the agency had tried to conduct an assessment but had not yet been able to obtain enough information. In June 2017, HHS officials said that they would reexamine how to conduct an assessment per our recommendation.
    Director: James C. Cosgrove
    Phone: (202) 512-7114

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

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

    Comments: To help improve the Centers for Medicare & Medicaid Service's (CMS) process for establishing relative values for Medicare physicians' services, in May 2015 we recommended that the Administrator of CMS better document the process, including the methods used to review recommendations from the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC) and the rationale for final relative value decisions. CMS concurred with this recommendation, stating that CMS establishes relative values for new, revised, and potentially misvalued physicians' services based on its review of a variety of sources of information, including the RUC. CMS officials told us the agency continues to improve the transparency of its process by proposing and finalizing changes to the process in the annual rule for the Physician Fee Schedule. Officials also told us that the agency is developing a means of displaying the direct practice expense inputs component of relative values in a consistent manner that will allow for greater transparency and documentation of the process, since currently the RUC recommends direct practice expense inputs to CMS through inconsistent formats that are not conducive to public transparency. Officials estimated that this process will take several years to complete. In order to close this recommendation as implemented, CMS will need to demonstrate that it has improved its internal and external documentation of its process for establishing relative values. As of August 2016, CMS has not provided any additional information about actions to address this recommendation.
    Recommendation: To help improve CMS's process for establishing relative values for Medicare physicians' services, the Administrator of CMS should develop a process for informing the public of potentially misvalued services identified by the RUC, as CMS already does for potentially misvalued services identified by CMS or other stakeholders.

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

    Comments: To help improve the Centers for Medicare & Medicaid Service's (CMS) process for establishing relative values for Medicare physicians' services, in May 2015 we recommended that the Administrator of CMS develop a process for informing the public of potentially misvalued services identified by the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC), as CMS already does for potentially misvalued services identified by CMS or other stakeholders. CMS did not concur with this recommendation, asserting that the RUC is completely independent of CMS, and as such CMS has no authority to set the RUC's agenda for which services are reviewed. CMS reiterated their non-concurrence in February 2016. CMS officials noted that they recognize that some stakeholders, including those who are not participants in the RUC process, may not be aware of the new, revised, and potentially misvalued services that are under review by CMS prior to the establishment of interim final values in a final rule. For this reason and others, CMS proposed and finalized a change in its process for establishing or revising relative values for new, revised, or potentially misvalued services. Beginning in 2016, CMS will begin including proposed values for some of services in the annual proposed rulemaking for the Physician Fee Schedule, which means that the changes in values for these services will be open for public comment prior to them being finalized. In 2017, changes in values for almost all services will be included in the proposed rule for the Physician Fee Schedule. We continue to believe that CMS needs to inform the public of potentially misvalued services identified by the RUC, as the agency does for potentially misvalued services identified by other stakeholders for review. While the elimination of most interim final values in 2017 will allow stakeholders to comment on values before they become effective, we believe it is still important for CMS to inform stakeholders of those services identified by the RUC as potentially misvalued before CMS received RUC recommendations for these services and subsequently publishes the values in the proposed rule each year. Doing so would give stakeholders more time to provide input on values for services if they so choose before CMS included its proposed values in the annual proposed rulemaking, and we worded our recommendation to allow CMS to determine how to inform stakeholders of these services without delaying the timing of its revision of misvalued services.
    Recommendation: To help improve CMS's process for establishing relative values for Medicare physicians' services, the Administrator of CMS should incorporate data and expertise from physicians and other relevant stakeholders into the process as well as develop a timeline and plan for using the funds appropriated by the Protecting Access to Medicare Act of 2014.

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

    Comments: To help improve the Centers for Medicare & Medicaid Service's (CMS) process for establishing relative values for Medicare physicians' services, in May 2015 we recommended that the Administrator of CMS incorporate data and expertise from physicians and other relevant stakeholders into the process, as well as develop a timeline and plan for using the funds appropriated by the Protecting Access to Medicare Act of 2014 (PAMA). CMS concurred with this recommendation, stating that stakeholders have the opportunity each year to nominate potentially misvalued services for review through a public nomination process. In order to develop a timeline and plan for using the funds appropriated by PAMA, CMS is assessing the research conducted by two external contractors to determine the most effective and fiscally responsible way to use the funds. This work is ongoing, and CMS is using this work to understand the data collection limitations that exist and help inform the development of a timeline for the use of PAMA funds. CMS anticipates releasing a contract solicitation prior to the end of the calendar year. In order to close this recommendation as implemented, CMS will need to demonstrate that it has incorporated data and expertise from relevant stakeholders and has developed a timeline and plan for using the funds appropriated by PAMA. As of August 2016, CMS has not provided any additional information about actions to address this recommendation.
    Director: Carol R. Cha
    Phone: (202) 512-4456

    1 open recommendations
    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: The Department of Health and Human Services has not implemented this recommendation. In April 2016, an audit liaison in the Office of the Chief Information Officer reported that each component maintains processes and procedures for device management. However, as of August 2017, the department had not provided evidence that components have established procedures that address the elements of our recommendation. We will continue to monitor the department's implementation of this recommendation.
    Director: Kay Brown
    Phone: (202) 512-7215

    1 open recommendations
    Recommendation: The Secretary of the Department of Health and Human Services should facilitate development of a cross-agency federal strategy to help ensure that federal resources from Administration for Community Living, CMS, USDA, HUD, and DOT are effectively and efficiently used to support a comprehensive system of HCBS and related supports for older adults. Through such a strategy the agencies could, for example, define common outcomes for affordable housing with supportive services, non-medical transportation, and nutrition assistance at the federal level; develop lessons learned for the local networks that area agencies on aging and community-based organizations are forming; and develop strategies for leveraging limited resources.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS agreed with this recommendation, noting that it continually strives to improve its strategic coordination and described ways that it facilitates cross agency strategic efforts, including a community-living initiative with HUD and an interagency workgroup on Olmstead requirements. HHS also described collaboration by HHS and HUD on policy research projects concerning housing and supportive services for older adults, including a comparison of health service utilization by older adults who live in assisted housing with those who do not and an evaluation of a demonstration in Vermont that provides services and supports to residents of HUD-assisted housing. We continue to encourage HHS to engage all five agencies to develop a cross agency federal strategy for administering home and community-based services for older adults. Using the eight practices to enhance and sustain interagency collaboration that we identified in prior work could help the five agencies address some of the challenges. In May 2016, HHS reported that it believes it addressed the recommendation and plans no additional action.
    Director: Seto J. Bagdoyan
    Phone: (202) 512-6722

    1 open recommendations
    Recommendation: To further improve efforts to limit improper payments, including fraud, in the Medicaid program, the Acting Administrator of CMS should provide guidance to states on the availability of automated information through Medicare's enrollment database--the Provider Enrollment, Chain and Ownership System (PECOS)--and full access to all pertinent PECOS information, such as ownership information, to help screen Medicaid providers more efficiently and effectively.

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

    Comments: HHS considers this recommendation closed because they provide states with training and direct access to PECOS on an ongoing basis. Additionally, CMS also makes Medicare Enrollment data available to states through custom data extracts. We do not consider this action sufficient to close the recommendation, to provide states information on the availability of automated information through PECOS. For example, custom extracts do not constitute automated information containing all information in PECOS states need to screen providers in Medicaid. Additionally, the states the we interviewed for our study were not aware that custom extracts were available. CMS should provide guidance to state Medicaid programs that this information is available until fully automated access to PECOS is available. We reached out to CMS about the status of this recommendation. As of May 2017, we have not received a response. We will continue to monitor progress on this recommendation.
    Director: Kathleen M. King
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: CMS should conduct a formal analysis, using its experience and data it has collected since the implementation of the first MAC contracts, to determine whether alternative contracting approaches could be used--even if only for selected MAC contract responsibilities--to help promote improved contractor performance.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Michelle Sager
    Phone: (202) 512-6806

    3 open recommendations
    Recommendation: To better ensure the adherence to requirements for approval and public access to and feedback on significant guidance in accordance with OMB's Final Bulletin for Agency Good Guidance Practices (M-07-07), the Secretary of HHS should develop written procedures for the approval of significant guidance documents.

    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 explore the best mechanism for distributing written procedures for approval of significant guidance. As of August 2017, GAO is working with HHS officials to obtain additional updates and documentation regarding 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 strengthen their selected components' application of internal controls to guidance processes by adopting, as appropriate, practices developed by other departments and components, such as assessment of risk; written procedures and tools to promote the consistent implementation and communication of management directives; and ongoing monitoring efforts to ensure that guidance is being issued appropriately and has the intended effect. Examples of practices that could be adopted more widely include (1) written procedures for guidance production to, among other things, clearly define management roles; (2) improved communication tools, such as routing slips to document management review; and (3) consistent and ongoing monitoring to determine if guidance is being accessed and having the intended effect.

    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 continue to work with its agencies to share best practices and ensure that agency practices are alighted with departmental standards. As of August 2017, GAO is working with HHS officials to obtain additional updates and documentation regarding 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 August 2017, GAO is working with HHS officials to obtain additional updates and documentation regarding the department's implementation of this recommendation.
    Director: Katherine Iritani
    Phone: (202) 512-7114

    2 open recommendations
    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: As of August 2016, the Department of Health and Human Services (HHS) has taken some steps to assess whether section 1115 expenditure authorities are likely to promote Medicaid objectives. HHS has posted on its website four "general criteria" for assessing whether a demonstration meets Medicaid program objectives:(1) increase and strengthen overall coverage of low-income individuals in the state; (2) increase access to, stabilize, and strengthen providers and provider networks available to serve Medicaid and low-income populations in the state; improve health outcomes for Medicaid and other low-income populations in the state; or (4) increase the efficiency and quality of care for Medicaid and other low-income populations through initiatives to transform service delivery networks. We believe this is a positive step but maintain that the general criteria are not sufficiently specific to allow a clear understanding of what HHS considers to be approvable for Medicaid purposes. For example, although each of HHS's four general criteria relate to serving low-income or Medicaid populations, HHS does not define low-income or what it means to serve these individuals. Until more specific guidance is established that more precisely explains how demonstrations relate to serving low-income and Medicaid populations, the rationale for the agency?s approvals of expenditure authorities, which can amount to billions of dollars in federal spending, will not be transparent. We will update the status of this recommendation when HHS provides more specific guidance on how it applies these criteria or alternatively issues more specific criteria.
    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: As of August 2016, the Department of Health and Human Services (HHS) has taken some steps to ensure the application of the criteria is documented in all approvals of section 1115 demonstrations. HHS stated that since the release of our report, the Centers for Medicare & Medicaid Services (CMS) has been identifying in Medicaid demonstration approval documents which of its general criteria each approved expenditure authority promotes. In a review of section 1115 demonstration approvals issued on or after July 1, 2015 and posted on HHS?s website as of August 12, 2016, we found that approved demonstration expenditure authorities were linked to HHS's general criteria in some but not all approvals. More consistent documentation of the basis for HHS's approvals will provide assurance that HHS is consistently applying its criteria and increase transparency around how individual expenditure authorities are considered to promote Medicaid objectives. We will continue to monitor CMS's efforts in this area.
    Director: Katherine M. Iritani
    Phone: (202) 512-7114

    3 open recommendations
    including 2 priority recommendations
    Recommendation: To improve CMS's oversight of Medicaid payments, the Administrator of CMS should take steps to ensure that states report accurate provider-specific payment data that include accurate unique national provider identifiers (NPI).

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

    Comments: HHS concurred with GAO's recommendation. As of September 2016, CMS has not provided additional information showing that the recommendation has been implemented. GAO considers it to be open. We will update the status of this recommendation when we receive additional information.
    Recommendation: To improve CMS's oversight of Medicaid payments, the Administrator of CMS should develop a policy establishing criteria for when such payments at the provider level are economical and efficient.

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

    Comments: HHS concurred with GAO's recommendation and as of October 2016 was evaluating ways to improve its oversight, including gathering information from states to better inform future policies. In November 2016, CMS plans to publish a proposed rule for public comment to improve the oversight of supplemental payments made to individual providers. Supplemental payments are large lump sum payments that most states make to certain providers and are not based on claims for services provided. According to CMS, the proposed rule will establish criteria for determining the economy and efficiency of Medicaid payments made to individual providers.
    Recommendation: To improve CMS's oversight of Medicaid payments, the Administrator of CMS should, once criteria are developed, develop a process for identifying and reviewing payments to individual providers in order to determine whether they are economical and efficient.

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

    Comments: HHS concurred with GAO's recommendation and as of October 2016 was evaluating ways to improve its oversight, including gathering information from states to better inform future policies. In November 2016, CMS plans to publish a proposed rule for public comment to improve the oversight of supplemental payments made to individual providers. According to CMS, the proposed rule will establish a process for identifying and reviewing payments to individual providers to determine if these payments meet the criteria of economy and efficiency established by the rule.
    Director: Linda T. Kohn
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: To help ensure that HHS fully addresses its dissemination requirements under PPACA, the Secretary of Health and Human Services should direct AHRQ to expand dissemination efforts to federal and private health plans and vendors of health information technology focused on clinical decision support.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS officials provided information in 2017 on dissemination efforts conducted as part of the Patient-Centered Outcomes Research Clinical Decision Support Learning Network. However, we have not yet identified the extent to which these efforts are specifically focused on federal and private health plans, or on health IT vendors, as specified in the GAO recommendation.
    Recommendation: To help ensure that HHS fully addresses its dissemination requirements under PPACA, the Secretary of Health and Human Services should direct AHRQ to document and complete plans to develop a publicly available database, including plans to meet the needs of various potential users in the general public.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS officials provided information in 2017 to describe AHRQ's approach to address dissemination requirements through a website that includes instructions and links for searching multiple different publicly available databases that have information on comparative effectiveness research. However, we have not yet identified the extent to which AHRQ has plans to meet the needs of various potential users in the general public, as specified in GAO's recommendation.
    Recommendation: To help ensure that HHS fully addresses its dissemination requirements under PPACA, the Secretary of Health and Human Services should direct AHRQ to develop specific plans on how it will collaborate with the National Institutes of Health on its dissemination activities.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: AHRQ officials provided information in 2017 on how AHRQ and NIH officials have been meeting with each other to collaborate on dissemination activities. However, we have not yet identified specific plans for this collaboration, as specified in GAO's recommendation.
    Director: Kay Brown
    Phone: (202) 512-7215

    2 open recommendations
    Recommendation: To improve the consistency of assistance provided to tribes, the Secretary of Health and Human Services should take steps to provide consistent title IV-E guidance to tribes across its regional offices.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In May 2015, HHS hired a tribal coordinator who will work in the Office of the Associate Commissioner of the Children's Bureau. The tribal coordinator's primary functions will include facilitating communication across the regions and with tribes to share experiences and information, so as to ensure greater consistency and clarity. While this hire represents an initial step towards improving communication with tribal title IV-E agencies, more time is needed for the tribal coordinator to implement policies and procedures that will ensure consistent title IV-E guidance to tribes across HHS regional offices. In May 2017, the agency reported that tribal coordinator position was ultimately elevated to the Office of the ACYF Commissioner and became the Commissioner's representative to the Tribes. We await documentation on any guidance provided to the regional offices that would help with consistency.
    Recommendation: To improve the timeliness of assistance provided to tribes, the Secretary of Health and Human Services should establish procedures to ensure reviews of draft title IV-E plans are conducted by regional office staff in a timely manner.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of May 2017, HHS stated that it does not anticipate taking action in response to this recommendation because of its existing protocols for communicating with and responding to tribal title IV-E grantees. We maintain that establishing procedures, including but not limited to timeframes for responses, would help ensure that tribes receive timely feedback from regional offices regarding their draft title IV-E plans.
    Director: Marcia Crosse
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To strengthen DEA's and FDA's ability to respond to shortages of drugs containing controlled substances, the Administrator of DEA and the Commissioner of FDA should, either in the MOU or in a separate agreement, specifically outline what information the agencies will share, and time frames for sharing such information, in response to a potential or existing drug shortage.

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

    Comments: In March 2015, DEA and FDA updated the MOU to establish procedures regarding the exchange of proprietary and other sensitive information between the two agencies. The MOU calls for the development of separate plans to specify what information is to be shared and who it is to be shared with. Since establishing the MOU, DEA said that it had met with FDA to determine the specific procedures for sharing information about drug shortages and a draft work plan has been circulated between the two agencies for comment. As of July 2016, FDA officials said that it has completed its section of the work plan related to sharing information about drug shortages. Although GAO has been advised by DEA that the workplan has not been finalized, in August 2017, FDA stated that it and DEA are actively sharing information and have successfully completed numerous exchanges. GAO is continuing to monitor the status of this recommendation.
    Director: Melvin, Valerie C
    Phone: (202) 512-6304

    1 open recommendations
    Recommendation: To ensure that the federal government's and states' investments in information systems result in outcomes that are effective in supporting efforts to save funds through the prevention and detection of improper payments in the Medicaid program, the Secretary of Health and Human Services should direct the Administrator of CMS to require states to measure quantifiable benefits, such as cost reductions or avoidance, achieved as a result of operating information systems to help prevent and detect improper payments. Such measurement of benefits should reflect a consistent and repeatable approach and should be reported when requesting approval for matching federal funds to support ongoing operation and maintenance of systems that were implemented to support Medicaid program integrity purposes.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In comments on our report, agency officials agreed with this recommendation and provided information on CMS's plans to use a template to track cost savings resulting from state Medicaid offices' use of information systems for program integrity purposes. In April 2017, CMS officials said that they were no longer planning to use the template to gather information from the states, because of the varied approaches that states take to implement systems support for program integrity purposes. The officials stated that they are developing an alternative approach for capturing this information from the states, which will be provided to us when completed. We will continue to monitor CMS's progress toward addressing the recommendation.
    Director: J. Alfredo Gómez
    Phone: (202) 512-3841

    1 open recommendations
    including 1 priority recommendation
    Recommendation: To help ensure the safety of food imported into the United States, the Commissioner of Food and Drugs should complete an analysis to determine the annual number of foreign food inspections that is sufficient to ensure comparable safety of imported and domestic food. If the inspection numbers from that evaluation are different from the inspection targets mandated in FSMA, FDA should report the results to Congress and recommend appropriate legislative changes.

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

    Comments: In January 2015, we recommended that the Commissioner of FDA complete an analysis to determine the annual number of foreign food inspections that is sufficient to ensure comparable safety of imported and domestic food. Additionally, if the inspection numbers from that analysis are different from the inspection targets mandated in the FDA Food Safety Modernization Act (FSMA), FDA should report the results to Congress and recommend appropriate legislative changes. At the time of our report, FDA was not keeping pace with FSMA's mandate to increase inspections each year from 2011 through 2016. In April 2017, FDA indicated that that it does not anticipate going significantly beyond 1,200 foreign food facilities inspections per year, based on the amount of additional funding needed to meet the foreign inspection requirement of FSMA. However, FDA has not conducted an analysis to determine whether the increased number of inspections mandated by FSMA or the lower number of inspections it is currently conducting is sufficient to ensure comparable safety of imported and domestic food. FDA noted that, in January 2017, it began an analysis to define and describe the global inventory of human and animal food firms and examine the application of regulatory oversight tools across the inventory. According to FDA, the analysis will help it assess the annual number of foreign food facility inspections as part of an overall risk-based allocation of resources for ensuring that imported foods are produced in a manner the meets applicable U.S. safety standards. We continue to believe that FDA should complete such an analysis and report the results to Congress.
    Director: Iritani, Katherine M
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: The Secretary of HHS should expand its outreach and educational efforts aimed at reducing antipsychotic drug use among older adults with dementia to include those residing outside of nursing homes by updating the National Alzheimer's Plan.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In May of 2015, the Department of Health and Human Services (HHS) noted that the agency believes GAO's recommendation is worth pursuing, but that due to the timing of the 2015 update to the National Plan to Address Alzheimer's Disease, inclusion in 2015 was not possible. HHS further stated that the GAO recommendation was being considered for inclusion in the 2016 update to the Plan as a part of an expansion of the Centers for Medicare & Medicaid Services' National Partnership to Improve Dementia Care program. However, HHS did not address the recommendation in the August 2016 update. As of September 2017, HHS had not updated its National Plan to Address Alzheimer's Disease in a manner that addresses our recommendation. Until HHS specifically targets its outreach and education efforts relating to antipsychotic drug use to settings other than nursing homes, older adults living outside of nursing homes, their caregivers, and their clinicians in these settings may not have access to the same resources about alternative approaches to care.
    Director: Linda Kohn
    Phone: (202) 512-7114

    1 open recommendations
    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. As of August 2017, HHS 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, this report is not yet complete. 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.
    Director: Brown, Kay E
    Phone: (202) 512-7215

    1 open recommendations
    Recommendation: To encourage broader adoption and evaluation of promising approaches and address impediments to the use of the career pathways approach among TANF agencies, HHS should, in consultation with Congress, identify potential changes that would address the lack of incentives for states and localities to adopt promising approaches and then develop and submit a legislative proposal outlining those changes.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In June 2015, HHS noted that the agency's fiscal year 2016 budget includes a proposal to increase incentives for states to implement or strengthen subsidized employment programs and notes the Administration's willingness to work with Congress to improve the TANF program's effectiveness in accomplishing its goals. Additionally, HHS reported that it continues to provide technical assistance and disseminate research to help encourage TANF agencies to adopt or strengthen employment-focused approaches. While we commend these efforts, we continue to believe it is important for HHS, in consultation with Congress, to identify potential changes that would address the lack of incentives for states and localities to adopt promising approaches and develop and submit a legislative proposal outlining those changes.
    Director: Linda T. Kohn
    Phone: (202) 512-7114

    4 open recommendations
    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 July 2015 CMS indicated that it is working to implement this recommendation. Specifically, it is actively investigating options for allowing a more targeted and consumer-centric individual user experience on Physician Compare. We will follow up to gather additional information from CMS officials as they continue their work.
    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 July 2015, CMS indicated that it is working to implement this recommendation. We will follow up to gather additional information from CMS officials as they continue their work.
    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 July 2015, CMS indicated that it is working to implement this recommendation. Specifically, it is evaluating feasibility of including estimated out-of-pocket costs on physician compare. We will follow up to gather additional information from CMS officials as they continue their work.
    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 July 2015, CMS indicated that it is working to implement this recommendation. CMS also noted that Physician Compare is in the early stages of public reporting, and is evaluating the feasibility of listing providers based on their performance in the new carefinder.gov project. We will follow up to gather additional information from CMS officials as they continue their work.
    Director: John Neumann
    Phone: (202) 512-3841

    5 open recommendations
    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

    Comments: In February 2015, FDA posted a report summarizing the results of its Fiscal Year 2012 Pesticide Monitoring Program. The report identified which pesticides the agency tested for in FY 2012. However, the report did not identify which pesticides with EPA-established tolerances were not tested for, nor did it discuss the potential effect of not testing for those pesticides. As of December 2016, FDA had not provided an updated status for this recommendation. It plans to provide a status update in early calendar year 2017.
    Recommendation: To gather and report reliable, nationally representative data on pesticide residue violations, the Secretary of Health and Human Services should direct the Commissioner of FDA to design and implement a statistically valid sampling methodology that would enable the agency, within existing resources, to gather nationally representative pesticide residue incidence and level data for both domestically produced and imported foods, or justify statistically the use of a nonprobability method that can measure the estimation error. In designing either approach, FDA should consider the extent to which the benefits exceed the costs.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In February 2015, FDA issued a report summarizing the results of its pesticide monitoring program for Fiscal Year 2012. This report followed by about 4 months the issuance of our report, GAO-15-38, in October 2014. The FDA report stated that the sampling methodology used in FY 2012 was not statistically based. However, in light of our recommendation that FDA design and implement a statistically valid sampling methodology, the agency could have used its February 2015 report to announce its plan to develop such a methodology for use in the future, but it did not do so. As of December 2016, FDA had not provided an updated status for this recommendation. It plans to provide a status update in early calendar year 2017.
    Recommendation: To gather and report reliable, nationally representative data on pesticide residue violations, the Secretary of Health and Human Services should direct the Commissioner of FDA to report the nationally representative incidence and level data in its annual pesticide monitoring reports, including disclosing the limits of its chosen sampling methodology.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of December 2016, FDA had not provided an updated status for this recommendation. It plans to provide a status update in early calendar year 2017.
    Recommendation: To evaluate and refine its targeted pesticide compliance and enforcement monitoring program, the Secretary of Health and Human Services should direct the Commissioner of FDA to use the incidence and level data to assess the effectiveness of FDA's targeted pesticide compliance and enforcement monitoring program, including its use of the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting targeting tool for imported foods, by comparing the rate of violations detected through the program to the overall rate of pesticide residue violations within the domestic and imported food supplies.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of December 2016, FDA had not provided an updated status for this recommendation. It plans to provide a status update in early calendar year 2017.
    Recommendation: To evaluate and refine its targeted pesticide compliance and enforcement monitoring program, the Secretary of Health and Human Services should direct the Commissioner of FDA to identify any types of domestic and imported foods that are at high risk for pesticide residue tolerance violations to improve the ability of its targeted pesticide compliance and enforcement monitoring program to consistently identify food likely to have violations.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of December 2016, FDA had not provided an updated status for this recommendation. It plans to provide a status update in early calendar year 2017.
    Director: David J.Wise
    Phone: (202) 512-2834

    1 open recommendations
    Recommendation: HUD, General Services Administration, HHS, and USICH should work together to address the challenges that homeless assistance providers face with the Title V homeless assistance program by (1) identifying what kinds of properties are most practical for homeless assistance, and (2) developing a web-based source of information on the program for homeless assistance providers.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: When we confirm what actions HHS has taken in response to this recommendation, we will provide updated information.
    Director: David A. Powner
    Phone: (202) 512-9286

    1 open recommendations
    Recommendation: The Secretaries of HHS, the Interior, Justice, and Labor, and the Administrators of GSA and NASA should complete action plans for addressing their challenges in reporting cost savings, as discussed in this report.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: The Department of Health and Human Services agreed with, and has taken initial steps to implement, our recommendation. In June 2015, the department reported that it had begun an effort to calculate the tangible cost savings and avoidances derived from closing over 50 data centers as part of its data center consolidation efforts. As of March 2017, the department reported that it had closed a total of 74 data centers and had identified $6.64 million in cost savings and avoidances, which is approximately $2.30 million more than what we reported in September 2014. However, the identified cost savings does not include any savings from fiscal years 2015 or 2016. Accordingly, we conclude the department has not yet completed efforts to address challenges in calculating cost savings and avoidances. We will continue to evaluate the department's progress in implementing this recommendation.
    Director: Beryl H. Davis
    Phone: (202) 512-2623

    2 open recommendations
    Recommendation: The Secretary of Health and Human Services should direct the Administrator of the Centers for Medicare and Medicaid Services to develop and implement policies and procedures for responding to nonroutine CCIIO-related financial management information requests, including procedures for documenting the preparation process and the review and approval of the results.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: The Department of Health and Human Services (HHS) disagreed with this recommendation. HHS management indicated that it has up-to-date and clearly documented standard operating procedures (SOP) for its normal day-to-day work processes, and did not believe that non-standard data requests lend themselves to documented, standard SOPs. In May 2016, HHS indicated that its position on this issue has not changed. In June 2017, HHS indicated that its position on this issue has not changed. GAO believes the recommendation is still valid.
    Recommendation: The Secretary of Health and Human Services should direct the Administrator of the Centers for Medicare and Medicaid Services to identify and evaluate options to facilitate more timely and independently verifiable reporting of CCIIO-related financial management information, such as enhancing Healthcare Integrated General Ledger Accounting System's standard reporting or custom reporting capabilities.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: The Department of Health and Human Services (HHS) disagreed with this recommendation. HHS indicated that it tracks appropriations in accordance with all relevant federal laws and regulations, and that the information was complete and verifiable. Federal accounting concepts and standards concerning managerial cost accounting allow flexibility for agency managers to develop costing methods that are best suited to their operational environment. HHS indicated that would continue to evaluate options of enhancing the standard and/or custom reporting capabilities of its core financial system; the Health Integrated General Ledger System (HIGLAS). In May 2016, HHS indicated that its position on this issue has not changed. In June 2017, HHS indicated that its position on this issue has not changed. GAO believes the recommendation is still valid.
    Director: James Cosgrove
    Phone: (202) 512-7114

    2 open recommendations
    including 2 priority recommendations
    Recommendation: To ensure that MA encounter data are of sufficient quality for their intended purposes, the Administrator of CMS should establish specific plans and time frames for using the data for all intended purposes in addition to risk adjusting payments to MAOs.

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

    Comments: HHS was in general agreement with this recommendation. In January 2017 we reported that CMS had made progress in defining its objectives for using MA encounter data for risk adjustment and in communicating its plans and time frames to MAOs. However, although CMS had formed general ideas of how it would use MA encounter data for purposes other than risk adjustment, it had not specified plans and time frames for most of the additional purposes for which encounter data may be used. These other purposes include activities to support program integrity. As of July 2017, CMS officials told us that the agency had not taken any further actions in response to this July 2014 recommendation.
    Recommendation: To ensure that MA encounter data are of sufficient quality for their intended purposes, the Administrator of CMS should complete all the steps necessary to validate the data, including performing statistical analyses, reviewing medical records, and providing MAOs with summary reports on CMS's findings, before using the data to risk adjust payments or for other intended purposes.

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

    Comments: While in general agreement with this recommendation, HHS did not commit to completing data validation before using MA encounter data for risk adjustment. In January 2017 we reported that CMS had made limited progress toward validating encounter data by having begun compiling basic statistics on the volume and consistency of data submissions and preparing automated summary reports for MAOs indicating the diagnosis information used for risk adjustment. However the agency had not yet taken other important steps identified in its Medicaid encounter data validation protocol, such as establishing benchmarks for completeness and accuracy. In July 2017, CMS officials told us that the agency had not taken any further actions in response to this July 2014 recommendation.
    Director: Katherine M. Iritani
    Phone: (202) 512-7114

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

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

    Comments: In November 2016, CMS reported that states provide assurances to CMS that they are adhering to statutory requirements, such as the limit that no more than 60 percent of the nonfederal share of a state's total annual Medicaid expenditures may come from local sources. This process was in place prior to GAO's July 2014 report, and in its written comments in response to that report, the Department of Health and Human Services (HHS) acknowledged that it does not have adequate data on state financing methods for overseeing compliance with this requirement. HHS added that it will examine efforts to improve data collection toward this end. In July 2016, CMS reiterated that it did not consider T-MSIS to be the correct method to gather information on state sources of the nonfederal share. GAO continues to believe it is important that CMS and federal policymakers have more complete information about how increasing federal costs are impacting the Medicaid program, including beneficiaries and the providers who serve them and plans to continue to monitor CMS's actions to help ensure that states report accurate and complete data on all sources of the nonfederal share.
    Director: Kathleen M. King
    Phone: (202) 512-7114

    1 open recommendations
    including 1 priority recommendation
    Recommendation: In order to improve the efficiency and effectiveness of Medicare postpayment claims review efforts and simplify compliance for providers, the Administrator of CMS should monitor the Recovery Audit Data Warehouse to ensure that all postpayment review contractors are submitting required data and that the data the database contains are accurate and complete.

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

    Comments: As of March 2017, CMS had taken initial steps to monitor the Recovery Audit Data Warehouse, including implementing a new process to monitor monthly compliance reports on the data that contractors enter into the Warehouse. However, CMS noted that as it is in the beginning stages of implementing these compliance reports, it does not currently verify that contractors upload all of the records that they reviewed, nor does it assess the accuracy of the records they entered into the Warehouse. Also, CMS indicated that it does not currently monitor whether certain contractors "suppress" claims in the Warehouse that those contractors are considering for review as part of an investigation. CMS said it was considering additional options for future monitoring of compliance reports, but did not indicate when it would determine what additional steps to take. To close this recommendation, CMS should take additional steps to improve its oversight of the Recovery Audit Data Warehouse, such as verifying that contractors upload all of the records that they reviewed and taking steps to assess the accuracy of the records they uploaded.
    Director: Carol R. Cha
    Phone: (202) 512-4456

    6 open recommendations
    Recommendation: To ensure the effective management of software licenses, the Secretary of Health and Human Services should develop an agency-wide comprehensive policy for the management of software licenses that addresses the weaknesses we identified.

    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. We have requested documentation regarding implementation of this recommendation, and as of July 2017, are awaiting a response. We will follow up with HHS to obtain supporting documentation and continue monitoring its progress in implementing this recommendation.
    Recommendation: To ensure the effective management of software licenses, the Secretary of Health and Human Services should employ a centralized software license management approach that is coordinated and integrated with key personnel for the majority of agency software license spending and/or enterprise-wide licenses.

    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. We have requested documentation regarding implementation of this recommendation, and as of July 2017, are awaiting a response. We will follow up with HHS to obtain supporting documentation and continue monitoring its progress in implementing this recommendation.
    Recommendation: To ensure the effective management of software licenses, the Secretary of Health and Human Services should establish a comprehensive inventory of software licenses using automated tools for the majority of agency software license spending and/or enterprise-wide licenses.

    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. We have requested documentation regarding implementation of this recommendation, and as of July 2017, are awaiting a response. We will follow up with HHS to obtain supporting documentation and continue monitoring its progress in implementing this recommendation.
    Recommendation: To ensure the effective management of software licenses, the Secretary of Health and Human Services should regularly track and maintain a comprehensive inventory of software licenses using automated tools and metrics

    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. We have requested documentation regarding implementation of this recommendation, and as of July 2017, are awaiting a response. We will follow up with HHS to obtain supporting documentation and continue monitoring its progress in implementing this recommendation.
    Recommendation: To ensure the effective management of software licenses, the Secretary of Health and Human Services should analyze agency-wide software license data, such as costs, benefits, usage, and trending data, to identify opportunities to reduce costs and better inform investment decision making.

    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. We have requested documentation regarding implementation of this recommendation, and as of July 2017, are awaiting a response. We will follow up with HHS to obtain supporting documentation and continue monitoring its progress in implementing this recommendation.
    Recommendation: To ensure the effective management of software licenses, the Secretary of Health and Human Services should provide software license management training to appropriate agency personnel addressing contract terms and conditions, negotiations, laws and regulations, acquisition, security planning, and configuration management.

    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. We have requested documentation regarding implementation of this recommendation, and as of July 2017, are awaiting a response. We will follow up with HHS to obtain supporting documentation and continue monitoring its progress in implementing this recommendation.
    Director: David A. Powner
    Phone: (202) 512-9286

    2 open recommendations
    Recommendation: The Secretaries of Defense, Health and Human Services, Homeland Security, and Transportation should modify, finalize, and implement their agencies' policies governing incremental development to ensure that those policies comply with OMB's guidance, once that guidance is made available.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: The Department of Health and Human Services (HHS) has begun to take steps to address this recommendation. Specifically, in January 2015, HHS established a working group on incremental development in order to define a methodology for more rapid development. Further, HHS officials reported in April 2017 that the department was working to finalize its new guidance on incremental development and CIO certification as required by OMB guidance but could not provide a time frame for when the policy would be finalized. Until HHS finalizes and implements its incremental development policy, its information technology expenditures are more likely to produce sub-optimal results. We will continue to evaluate HHS's progress in implementing this recommendation.
    Recommendation: When updating their policies, the Secretaries of Defense, Health and Human Services, Homeland Security, and Transportation should consider the factors identified in this report as enabling and inhibiting incremental development.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: The Department of Health and Human Services (HHS) has begun to take steps to address this recommendation. Specifically, in January 2015, HHS established a working group on incremental development in order to define a methodology for incremental development that would address the factors identified in the report. Further, HHS officials reported in April 2017 that the department was working to finalize its new guidance on incremental development and CIO certification as required by OMB guidance but could not provide a time frame for when the policy would be finalized. Until HHS updates and implements its incremental development policy, its information technology expenditures are more likely to produce sub-optimal results. We will continue to evaluate HHS's progress in implementing this recommendation.
    Director: Stephen M. Lord
    Phone: (202) 512-6722

    1 open recommendations
    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 a July 2016 written response, Health and Human Services (HHS) stated that the Centers for Medicare & Medicaid Services (CMS) in collaboration with the Substance Abuse and Mental Health Services Administration (SAMHSA), issued an informational bulletin in August 2012 and in July 2013, that addressed this recommendation. However, in the report, we acknowledged that CMS issued this bulletin along with other guidance. Further, as we stated in our report, the HHS guidance did not address third-party MCOs administering medications. 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.
    Director: James Cosgrove
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: As CMS implements and refines its physician feedback and Value Modifier (VM) programs, to help ensure physicians can best use the feedback to improve their performance, the Administrator of CMS should consider developing performance benchmarks that compare physicians' performance against additional benchmarks such as state or regional averages.

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

    Comments: CMS stated that it would consider the GAO recommendation regarding the use of additional benchmarks to compare physician performance. In addition, Congress passed legislation in 2015 requiring CMS to incorporate certain benchmark methodologies, including the use of both improvement and achievement. The agency is also replacing the Value Modifier program with a new merit-based incentive payment system. CMS may, in time, address GAO recommendations to develop additional performance benchmarks, but they have yet to be fully implemented. As of August 2017, CMS officials have not implemented this recommendation. GAO considers it to be open. We will update the status of this recommendation when we receive additional information.
    Director: Linda T. Kohn
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: To address challenges that affect the ability of providers to electronically exchange health information, the Secretary of Health and Human Services should direct CMS and ONC to develop and prioritize specific actions that HHS will take consistent with the principles in HHS's strategy to advance health information exchange.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of August 28, 2014, HHS provided some information indicating that it had begun the process of developing milestones with time frames for its actions toward advancing exchange, and that it plans to make them publicly available. Because HHS has only just begun the process and has not provided documentation, these actions are in progress and therefore not complete. We will follow up in fiscal year 2015 to gather additional information to determine if the actions fully address the recommendation.
    Recommendation: To address challenges that affect the ability of providers to electronically exchange health information, the Secretary of Health and Human Services should direct CMS and ONC to develop milestones with time frames for the actions to better gauge progress toward advancing exchange, with appropriate adjustments over time.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of August 28, 2014, HHS provided some information indicating that it had begun the process of developing milestones with time frames for its actions toward advancing exchange, and that it plans to make them publicly available. Because HHS has only just begun the process and has not provided documentation, these actions are in progress and therefore not complete. We will follow up in fiscal year 2015 to gather additional information to determine if the actions fully address the recommendation.
    Director: Yocom, Carolyn L
    Phone: (202) 512-4931

    3 open recommendations
    including 2 priority recommendations
    Recommendation: To more effectively use CQMs to assess provider performance, the Secretary of Health and Human Services should direct CMS and ONC to develop a comprehensive strategy for ensuring that CQM data collected and reported using certified EHR technology are reliable, including testing for and mitigation of reliability issues arising from variance in certified EHR systems tested to different CQM specifications.

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

    Comments: In July 2015, CMS added that the agency is addressing the issue of reliability through the measure development process. Specifically, CMS stated that the agency has made tools available to measure developers which help to clarify the intent of the measure, catch errors in the development process, and minimize measure complexity. As of October 2016, CMS indicated that its National Testing Collaborative oversees implementation testing of quality measures, including testing for reliability issues. However, the agency did not indicate how these efforts constitute a comprehensive strategy, in conjunction with ONC, for achieving CQM reliability, as we recommended. In April 2017, CMS indicated that its pilot test of the National Testing Collaborative proved unsuccessful, and that CMS is continuing to look at how to best incorporate implementation testing into measure development and implementation. The agency did not indicate it has a comprehensive strategy for these efforts. We will update the status of this recommendation when we receive additional information.
    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
    Priority recommendation

    Comments: 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. However, in reviewing those materials, we did not see evidence that HHS has developed outcome-oriented performance measures that align to the intended outcomes of the EHR programs?that is, goals related to improving health care quality, efficiency, and patient safety. We will update the status of this recommendation when we receive additional information.
    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, HHS officials provided us documents, which they indicated show how information gathered through monitoring activities was used to inform the EHR programs. However, in reviewing those materials, we did not see evidence that HHS used information collected through outcome-oriented performance measures noted above. We will update the status of this recommendation when we receive additional information.
    Director: Marcia Crosse
    Phone: (202) 512-7114

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

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

    Comments: In August 2017, FDA reported that it had not conducted any rigorous analysis of predictors of drug shortages nor have new drug risk factors been identified. Although FDA adopted a new, commercially developed data system, the "Shortage Tracker" to track drug shortages in March 2016, it is used to help the Drug Shortage Staff manage their workload. FDA reported that this system has now been fully operational for over a year. However, no trend analysis relating to drug shortages has been conducted and the agency has no plans to conduct such analyses at this time.
    Director: Wilshusen, Gregory C
    Phone: (202) 512-6244

    2 open recommendations
    Recommendation: To improve the implementation of the act, the Secretary of Health and Human Services should ensure the DIB reviews cost-benefit analyses to make certain cost savings information for the computer matching program is included before approving CMAs.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: We have not yet received information to validate the agency's actions on this recommendation. Subsequent to the agency stating that is has taken action, we plan to verify whether implementation has occurred.
    Recommendation: To improve the implementation of the act, the Secretary of Health and Human Services should ensure the DIB performs annual reviews and submits annual reports on agency computer matching activities, as required by the act.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: We have not yet received information needed to validate agency actions on this recommendation. Subsequent to the agency stating that is has taken action, we plan to verify whether implementation has occurred.
    Director: Dicken, John E
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: The Secretary of HHS should direct the Administrator of CMS to monitor the relationship between PPACA-based FULs and the NADACs on an ongoing basis to help determine whether PPACA-based FULs effectively control federal Medicaid expenditures without reducing beneficiary access to drugs subject to FULs over time.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As part of the final rule implementing the PPACA-based FUL formula, CMS monitors the relationship between the FUL and the NADAC for individual drugs on an ongoing basis and ensures that the FUL does not fall below the NADAC. CMS, however, does not monitor the relationship between the FUL and NADAC in aggregate. This monitoring would provide CMS information on the extent to which the FUL effectively controls federal Medicaid expenditures, particularly in cases where there may be potential for over-reimbursement. CMS officials expect that, by mid-2017, many states will determine reimbursement using an average acquisition cost based on the NADAC. As a result, any potential variation between the FUL and NADAC would be reduced according to CMS officials. We plan to obtain state plan amendments from CMS to confirm whether states are reimbursing at an average acquisition cost or using some other methodology to control Medicaid expenditures.
    Director: Kohn, Linda T
    Phone: (202) 512-7114

    5 open recommendations
    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 Centers for Medicare & Medicaid Services (CMS) to establish key requirements for qualified CDRs that focus on improving quality and efficiency. These requirements could include, for example, having CDRs (1) identify key areas of opportunity to improve quality and efficiency for their target populations and collect additional measures designed to address them, (2) collect a core set of measures established by CMS, and (3) demonstrate that their processes for auditing the accuracy and completeness of the data they collect are systematic and rigorous.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As it has since initiation of the qualified CDR program, CMS continues to allow qualified CDRs to choose what quality measures they will track within very broad parameters. While it has developed a PQRS cross-cutting measure set requirement for physicians using other reporting mechanisms, this requirement does not apply to qualified CDRs. CMS officials report that they have addressed data accuracy and completeness by sharing with qualified CDRs issues and discrepancies that have been found in the data submitted so far.
    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: CMS officials report that they are working to implement this recommendation, but they have not yet put forward any specific proposals to address it.
    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: The limited changes for qualified clinical data registries that CMS outlined in its CY2016 proposed rule in July 2015 do not address this recommendation. CMS officials report that they are working to implement this recommendation, but the approach they describe focuses on assessing changes in the data submitted by qualified CDRs over several years.
    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: The limited changes for qualified clinical data registries that CMS outlined in its CY2016 proposed rule in July 2015 do not address the specific barriers to the development of qualified CDRs that we identified in our report. However, CMS officials report that they have provided technical assistance to qualified CDRs through monthly support calls and an annual kick-off meeting held in spring 2015.
    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: The limited changes for qualified clinical data registries that CMS outlined in its CY2016 proposed rule in July 2015 do not address this recommendation.
    Director: King, Kathleen M
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: In an effort to ensure that IHS has meaningful information on the timeliness with which it issues purchase orders authorizing payment under the CHS program and to improve the timeliness of payments to providers, the Secretary of the Department of Health and Human Services (HHS) should direct the Director of IHS to: (1) modify IHS's claims data system to separately track IHS referrals and self-referrals, revise the Government Performance Results Act measure for the CHS program so that it distinguishes between these two types of referrals, and establish separate timeframe targets for these referral types; and (2) improve the alignment between CHS staffing levels and workloads by revising its current practices, where appropriate, to allow available funds to be used to pay for CHS program staff.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of July 2016, HHS officials reported that they have not implemented this recommendation. GAO considers it to be open. We will update the status of this recommendation when we receive additional information.
    Recommendation: As HHS and IHS monitor the effect that new coverage options available to IHS beneficiaries through PPACA have on CHS program funds, the Secretary of HHS direct should the Director of IHS to proactively develop potential options to streamline program eligibility requirements.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of July 2016, HHS officials reported that they have not implemented this recommendation. GAO considers it to be open. We will update the status of this recommendation when we receive additional information.
    Director: Wilshusen, Gregory C
    Phone: (202) 512-6244

    3 open recommendations
    Recommendation: To improve their response to data breaches involving PII, the Secretary of Health and Human Services should direct the Administrator for the Centers for Medicare & Medicaid Services to require documentation of the risk assessment performed for breaches involving PII, including the reasoning behind risk determinations.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: We have not yet validated agency actions on this recommendation. Subsequent to the department stating that it has taken action, we plan to verify whether implementation has occurred.
    Recommendation: To improve their response to data breaches involving PII, the Secretary of Health and Human Services should direct the Administrator for the Centers for Medicare & Medicaid Services to document the number of affected individuals associated with each incident involving PII.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: We have not yet validated agency actions on this recommendation. Subsequent to the department stating that it has taken action, we plan to verify whether implementation has occurred.
    Recommendation: To improve their response to data breaches involving PII, the Secretary of Health and Human Services should direct the Administrator for the Centers for Medicare & Medicaid Services to require an evaluation of the agency's response to data breaches involving PII to identify lessons learned that could be incorporated into agency security and privacy policies and practices.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: We have not yet validated agency actions on this recommendation. Subsequent to the department stating that it has taken action, we plan to verify whether implementation has occurred.
    Director: Crosse, Marcia G
    Phone: (202) 512-7114

    2 open recommendations
    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 September, 2016, we are still awaiting an update from HHS on the status of any efforts 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 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 September, 2016, we are still awaiting an update from HHS on the status of any efforts to implement this recommendation. We will update the status of this recommendation when we receive additional information.
    Director: Crosse, Marcia G
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: To improve the usefulness of IACC data and enhance its efforts to coordinate HHS autism activities and monitor all federally funded autism activities, the Secretary of Health and Human Services should direct the IACC and NIH, in support of the IACC, to provide consistent guidance to federal agencies when collecting data for the portfolio analysis and web tool so that information can be more easily and accurately compared over multiple years.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS continues to disagree with this recommendation. In the spring of 2016 NIH released fiscal years 2011 and 2012 data, and in the spring of 2017, it released fiscal year 2013 data and made these data available through the IACC Web Tool. GAO continues to believe that the issuance of consistent guidance could enhance coordination and monitoring and that implementing this recommendation would be beneficial.
    Recommendation: To improve the usefulness of IACC data and enhance its efforts to coordinate HHS autism activities and monitor all federally funded autism activities, the Secretary of Health and Human Services should direct the IACC and NIH, in support of the IACC, to create a document or database that provides information on non-research autism-related activities funded by the federal government and make this document or database publicly available.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS continues to disagree with this recommendation. However, GAO believes that having a document or database that contains current information on these non-research activities is an important aspect of fulfilling the IACC's responsibility to monitor all federal autism activities, not just research. In May 2016, we issued another report on federal autism activities (GAO-16-446). During our work for this engagement, we found that HHS and the IACC have recently taken actions required by the Autism CARES Act that could help coordinate federal non-research autism activities and implement our November 2013 recommendation. First, as directed by the act, in April 2016, the Secretary of Health and Human Services designated an official to serve as the Autism Coordinator to oversee national autism research, services, and support activities and ensure that autism activities funded by HHS and other federal agencies are not unnecessarily duplicative. Secondly, the Act required the development of a strategic plan for autism research, including for services and supports as practicable, for individuals with autism and the families of such individuals. The plan is to include recommendations to ensure that autism research, and services and support activities to the extent practicable, of HHS and other federal departments and agencies are not unnecessarily duplicative. During IACC meetings in 2016, NIH staff and IACC members discussed updating the strategic plan to include services and supports. This plan is expected to be published in calendar year 2017. We acknowledge the steps taken by HHS and the IACC in response to the Autism CARES Act; however, we believe continued action is needed to develop these initial steps into methods for identifying and monitoring non-research autism-related activities funded by the federal government. We believe that continued fulfillment of provisions in the Autism CARES Act could help the department implement GAO's 2013 recommendation.
    Recommendation: To improve the usefulness of IACC data and enhance its efforts to coordinate HHS autism activities and monitor all federally funded autism activities, the Secretary of Health and Human Services should direct the IACC and NIH, in support of the IACC, to identify projects through its monitoring of federal autism activities--including Office of Autism Research Coordination's annual collection of data for the portfolio analysis and the IACC's annual process to update the strategic plan--that may result in unnecessary duplication and thus may be candidates for consolidation or elimination, and identify potential coordination opportunities among agencies.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS continues to disagree with this recommendation. However, GAO questions the purpose and value of devoting federal resources to collecting these data, if they are not then used to ensure federal funds are used appropriately. In May 2016, we issued another report on federal autism activities (GAO-16-446), which among other topics, examined the steps HHS and other federal agencies have taken to improve coordination and help avoid unnecessary duplication in autism research. We reported that HHS has recently taken actions required by the Autism CARES Act that could help coordinate federal autism research and implement our November 2013 recommendation. First, as directed by the act, in April 2016 the Secretary of Health and Human Services designated an official to serve as the Autism Coordinator to oversee national autism research, services, and support activities and ensure that autism activities funded by HHS and other federal agencies are not unnecessarily duplicative. Second, the Autism Cares Act requires that the IACC's strategic plan include recommendations to ensure that autism research funded by HHS and other federal agencies is not unnecessarily duplicative. During IACC meetings in 2016, NIH staff and IACC members discussed updating the strategic plan, including the aforementioned requirement. This plan is expected to be published in calendar year 2017. We acknowledge the steps taken by HHS and the IACC in response to the Autism CARES Act; however, until the designated Autism Coordinator takes steps to meet the act's requirements and the forthcoming strategic plan is published, there is a risk that opportunities to coordinate and create efficiencies and avoid unnecessary duplication in federal autism research will not be seized. We believe that continued fulfillment of provisions in the Autism CARES Act could help the department implement GAO's 2013 recommendation.
    Director: Kohn, Linda T
    Phone: (202) 512-7114

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

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

    Comments: As of July 7, 2015, NIH provided some information indicating that it had taken action to address our recommendation by tracking the size of indirect costs as a proportion of NIH's overall budget as part of the agency's annual budget planning process and risk assessment program. However, we determined that the actions did not fully address the recommendation because they focus on the agency's overall budget and do not assess the potential ongoing impact of indirect costs for universities on its mission. As of August 2017, NIH officials have not informed us of any additional actions taken to implement this recommendation. We will update the status of this recommendation when we receive additional information.
    Director: Powner, David A
    Phone: (202) 512-9286

    1 open recommendations
    Recommendation: The Secretary of Health and Human Services should direct appropriate officials to assess whether it would be cost effective to consolidate the remaining functions of the Medicare coverage determination systems.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: We contacted the department and are awaiting a response on its efforts to implement this recommendation.
    Director: Crosse, Marcia G
    Phone: (202) 512-7114

    2 open recommendations
    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 establish performance measures that include time frames for making final decisions on SE submissions and Exemption from SE submissions.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: FDA has established performance measures that include time frames for reviewing and acting on some of its new tobacco product submissions, including regular Substantial Equivalence (SE) submissions and Exemption from SE submissions, received in fiscal years 2015 through 2018. However, as of September, 2017, FDA has not developed performance measures for provisional SE submissions, the type of SE submissions that represent new tobacco products that may continue to be marketed unless and until FDA's Center for Tobacco Products finds that they are not substantially equivalent. We are keeping this recommendation open until the agency establishes performance measures, including time frames for making final decisions, for provisional SE submissions.
    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 monitors 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, because the agency has not yet reported establishing and monitoring performance measures for provisional SE submissions, we are leaving this recommendation open as of August 2017.
    Director: King, Kathleen M
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: To help ensure successful outreach efforts resulting in significant new enrollment, the Secretary of Health and Human Services should direct the Director of IHS to prepare for the increase in eligibility for expanded Medicaid and new coverage options, and the need for enrollment assistance and billing capacity, by realigning current resources and personnel to increase capacity to assist with these efforts.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of January 2017, IHS has reported that it developed a business plan template to help maximize capacity building and enrollment activities at the local level in coordination with IHS Headquarters and Area Offices. The agency reported that it will monitor the overall implementation process through performance plan evaluations of local leadership by their respective Area Directors. Until we receive documentation of these efforts, this recommendation will remain open.
    Recommendation: To help ensure successful outreach efforts resulting in significant new enrollment, the Secretary of Health and Human Services should direct the Administrator of CMS to develop a plan to educate state Medicaid agencies about when coverage status information may be shared between states and IHS facilities, tribal facilities, and urban Indian health programs (I/T/U) facilities and tribes.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of January 2017, CMS officials reported that the agency has implemented a plan to educate state Medicaid agencies about when coverage status information may be shared between states and I/T/U facilities on a case by case basis because of variation in how this information is shared from state to state. Until we receive documentation of the plan and its implementation, this recommendation will remain open.
    Director: Cosgrove, James C
    Phone: (202) 512-7114

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

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

    Comments: In August 2013, we recommended that the Administrator of the Centers for Medicare & Medicaid Services (CMS) insert a self-referral flag on its Medicare Part B claims form, require providers to indicate whether the intensity-modulated radiation therapy (IMRT) service for which a provider bills Medicare is self-referred, and monitor the effects that self-referral has on costs and beneficiary treatment selection. The Department of Health and Human Services (HHS) did not concur with this recommendation, noting that CMS does not believe that this recommendation will address overutilization that occurs as a result of self-referral, would be complex to administer, and may have unintended consequences. We continue to believe that such a flag on Part B claims would likely be the easiest and most cost-effective way for CMS to identify self-referred IMRT services and monitor the effects of self-referral. As of June 2017, CMS has not provided any additional information about actions it has taken to address this recommendation.
    Director: Brown, Kay E
    Phone: (202) 512-7215

    1 open recommendations
    Recommendation: To provide the basis for greater consistency across states in assessing elder justice service delivery, the Secretary of HHS, as chairman of the Elder Justice Coordinating Council, should direct the Council to make it a priority to identify common objectives for the federal elder justice effort and define common outcomes.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS agreed with this recommendation and noted the formation of the Elder Justice Coordinating Council (EJCC) as an effort to develop common objectives and plans for action to address elder justice issues. As of June 2014, the EJCC had developed eight recommendations for increased federal leadership in combating elder abuse based on input from elder justice experts in financial exploitation, public policy and awareness, enhancing response, and advancing research. Staff compiled information on best and promising practices for primary, secondary, and tertiary prevention; empirical evidence from peer-reviewed research; approaches used in related disciplines; and information about where gaps exist in the collective knowledge about elder abuse, neglect and exploitation. Staff then turned the suggestions into proposals with accompanying steps for federal action. Those proposals were subsequently presented at two public EJCC meetings (May and September 2013) and were made available for public review and comment. The Secretary of HHS formally accepted the recommendations in May 2014, and they were posted to the EJCC page of the Administration on Aging's website. In May 2015, HHS reported that the EJCC had published these recommendations in a document entitled "Eight (8)Recommendations for Increased Federal Involvement in Addressing Elder Abuse, Neglect, and Exploitation" and stated that the recommendations addressed the issues identified in GAO's recommendation. While we recognized that these 8 recommendations corresponded to the common objectives included in our recommendation, we also sought from HHS information on the status of common outcomes for the objectives. HHS reported that outcomes for the eight common objectives that the EJCC has approved were being discussed, but have not yet been approved. In March 2016,HHS reported that the EJCC's Elder Justice Working Group continued to gather and discuss action steps and outcomes for the eight recommendations. We will monitor the EJCC's progress in agreeing upon outcomes and close the recommendation when agreement on outcomes is reported.
    Director: Iritani, Katherine M
    Phone: (202) 512-7114

    2 open recommendations
    including 1 priority recommendation
    Recommendation: To improve the transparency of the process for reviewing and approving spending limits for comprehensive section 1115 demonstrations, the Secretary of Health and Human Services should update the agency's written budget neutrality policy to reflect actual criteria and processes used to develop and approve demonstration spending limits, and ensure the policy is readily available to state Medicaid directors and others.

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

    Comments: HHS does not agree with this recommendation. However, we continue to believe that HHS should have a formal written budget neutrality policy in place that reflects the Department's actual criteria and processes. HHS's written budget neutrality policy was last issued in 2001 and is not publicly available, and staff have acknowledged that aspects of the policy as written do not reflect their current criteria or processes.
    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 September 2016, HHS officials reported that they have not implemented this recommendation. GAO considers it to be open. We will update this information when we receive additional information
    Director: Cosgrove, James C
    Phone: (202) 512-7114

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

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

    Comments: In June 2013, we recommended that the Administrator of the Centers for Medicare & Medicaid Services (CMS) insert a self-referral flag on Medicare Part B claim forms and require providers to indicate whether the anatomic pathology services for which the provider bills Medicare are self-referred or not. The Department of Health and Human Services (HHS) did not concur with this recommendation, noting that CMS does not believe that this recommendation will address overutilization that occurs as a result of self-referral. We continue to believe that such a flag on Part B claims would likely be the easiest and most cost-effective way for CMS to identify self-referred anatomic pathology services and monitor the behavior of those providers who self-refer these services. As of June 2017, CMS has not provided any additional information about actions to address this recommendation.
    Recommendation: In order to improve CMS's ability to identify self-referred anatomic pathology services and help CMS avoid unnecessary increases in these services, the Administrator of CMS should determine and implement an approach to ensure the appropriateness of biopsy procedures performed by self-referring providers.

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

    Comments: In June 2013, we recommended that the Administrator of the Centers for Medicare & Medicaid Services (CMS) implement an approach to ensure the appropriateness of biopsy procedures performed by self-referring providers. The Department of Health and Human Services (HHS) does not concur with this recommendation and does not believe it would address overutilization that occurs as a result of self-referral. HHS noted that it would be difficult to make recommendations regarding whether anatomic pathology services are appropriate without reviewing a large number of claims. We continue to believe that it is important for CMS to monitor the self-referral of anatomic pathology services on an ongoing basis and determine if those services are inappropriate or unnecessary. We also continue to believe this can be achieved without reviewing a large number of claims. CMS could, for example, consider performing targeted audits of providers that perform a higher average number of biopsy procedures compared to providers of the same specialty treating similar numbers of Medicare beneficiaries. As of June 2017, CMS has not provided any additional information about actions to address this recommendation.
    Recommendation: In order to improve CMS's ability to identify self-referred anatomic pathology services and help CMS avoid unnecessary increases in these services, the Administrator of CMS should develop and implement a payment approach for anatomic pathology services that would limit the financial incentives associated with referring a higher number of specimens--or anatomic pathology services--per biopsy procedure.

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

    Comments: In June 2013, we recommended that the Administrator of the Centers for Medicare & Medicaid Services (CMS) develop and implement a payment approach for anatomic pathology services under the Physician Fee Schedule that would limit the financial incentives associated with referring a higher number of specimens--anatomic pathology services--per biopsy procedure. Although health care providers have discretion in determining the number of tissue samples from biopsy procedures that become specimens (anatomic pathology services), CMS's current payment system under the Physician Fee Schedule provides a financial incentive for providers to refer more specimens per biopsy procedure. Specifically, CMS pays for each specimen that a provider submits to be analyzed. HHS indicated that it concurred with our recommendation and that it had addressed this recommendation by reducing payment for the most commonly furnished anatomic pathology service (Current Procedural Terminology [CPT] code 88305) by approximately 30 percent in calendar year 2013. However, CMS's payment reduction did not change the financial incentive providers have to refer more specimens per biopsy procedure because they will still be paid separately for each specimen submitted. We continue to believe that CMS should develop a payment approach that addresses this incentive. As of June 2017, CMS had not provided any additional information about actions it has taken to address this recommendation.
    Director: Cosgrove, James C
    Phone: (202) 512-7114

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

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

    Comments: As of September 2016, HHS officials have not implemented this recommendation. GAO considers it to be open. We will update the status of this recommendation when we receive additional information.
    Recommendation: To help ensure that ADI suppliers provide consistent, safe, and high-quality imaging to Medicare beneficiaries, the Administrator of CMS should develop an oversight framework for evaluating accrediting organization performance, which could include collecting and analyzing information on accreditation results and conducting validation audits.

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

    Comments: As of September 2016, HHS officials have not implemented this recommendation. GAO considers it to be open. We will update the status of this recommendation when we receive additional information.
    Recommendation: To help ensure that ADI suppliers provide consistent, safe, and high-quality imaging to Medicare beneficiaries, the Administrator of CMS should develop more specific requirements for accrediting organization mid-cycle audit procedures and clarify guidance on immediate-jeopardy deficiencies to ensure consistent identification and timely correction of serious care problems for the duration of accreditation.

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

    Comments: As of September 2016, HHS officials have not implemented this recommendation. GAO considers it to be open. We will update the status of this recommendation when we receive additional information.
    Director: King, Kathleen M
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To improve the effectiveness of the unpublished MUEs and better ensure Medicare program integrity, the CMS Administrator should consider periodically reviewing claims to identify the providers exceeding the unpublished MUE limits and determine whether their billing was proper.

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

    Comments: In its comments on a draft of this report, HHS concurred with this recommendation and indicated that CMS would conduct further analysis to determine the most appropriate way to respond. In July 2015, HHS told us that CMS has established a process to identify providers exceeding the unpublished MUE limits and determine whether their billing was proper. In August 2016, CMS informed us that the agency is developing a process to review provider level data to determine potential improper billing that exceeds unpublished MUE limits. However, as of September 2016, CMS has not yet implemented this process. We requested that CMS provide documentation of the process once it has been implemented. With this documentary support, we hope to close the recommendation.
    Director: King, Kathleen M
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: Should the Congress decide to cap payments for physician and other nonhospital services made through IHS's CHS program, the Secretary of Health and Human Services should direct the Director of IHS to monitor CHS program patient access to physician and other nonhospital care in order to assess how any new payment rates may benefit or impede the availability of care.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS agreed with GAO's recommendation and indicated that monitoring patient access to care in light of any payment changes is essential to providing high-quality health care to American Indians and Alaska Natives. Since there have not been any changes to the payment rates, IHS has not yet implemented this recommendation.
    Director: Crosse, Marcia G
    Phone: (202)512-3407

    2 open recommendations
    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.
    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). As a result of the change to HPP's measures, GAO anticipates keeping this recommendation open at least for the next few budget periods, in order to determine whether HPP maintains consistency with its new performance measures during the new project cycle.
    Director: Gomez, Jose A
    Phone: (202) 512-3841

    2 open recommendations
    Recommendation: To enhance FDA's ability to use AERs and to oversee dietary supplement products, the Secretary of the Department of Health and Human Services should direct the Commissioner of FDA to incorporate a mechanism to collect information on when AERs are used to support and inform consumer protection actions (i.e., surveillance, advisory, and regulatory actions).

    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 update this information.
    Recommendation: To enhance FDA's ability to use AERs and to oversee dietary supplement products, the Secretary of the Department of Health and Human Services should direct the Commissioner of FDA to establish a time frame for issuing final guidance for the draft (1) New Dietary Ingredient (NDI) guidance and (2) guidance clarifying whether a liquid product may be labeled and marketed as a dietary supplement or as a conventional food with added ingredients.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: Although FDA issued final guidance for distinguishing liquid dietary supplements from beverages in January 2014, it has not yet issued final guidance on new dietary ingredients (NDI). Once FDA completes the NDI guidance, we can close the recommendation.
    Director: Cosgrove, James C
    Phone: (202) 512-7114

    1 open recommendations
    including 1 priority recommendation
    Recommendation: To reduce the incentive for facilities to restrict their service provision to avoid reaching the LVPA treatment threshold, the Administrator of CMS should consider revisions such as changing the LVPA to a tiered adjustment.

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

    Comments: CMS stated in April 2017 that the agency would continue examining the performance of the LVPA to determine whether a tiered adjustment is warranted.
    Director: Cosgrove, James C
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: As CMS continues to implement and refine the Value Modifier program to enhance the quality and efficiency of physician care, the Administrator of CMS should consider whether certain private-sector practices could broaden and strengthen the program's incentives. Specifically, she should consider (1) developing at least some performance benchmarks that reward physicians for improvement as well as for meeting absolute performance benchmarks, and (2) making Value Modifier adjustments more timely in order to better reflect recent physician performance.

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

    Comments: CMS stated that it is working to implement GAO's recommendation. Previously, the agency noted that it would investigate accelerating the timeline of the Value Modifier, keeping in mind reporting requirements, data availability, and the need for valid and reliable measures. In addition, Congress passed legislation in 2015 requiring CMS to incorporate certain benchmark methodology and timing aspects that reflect GAO's 2013 recommendation, and the agency is replacing the Value Modifier with a new merit-based incentive payment system. CMS's efforts may, in time, address GAO recommendations to improve performance benchmarks and the timeliness of payment adjustments, but they have yet to be fully implemented. As of August 2017, CMS officials have not implemented this recommendation. GAO considers it to be open. We will update the status of this recommendation when we receive additional information.
    Recommendation: The Administrator should develop a strategy to reliably measure the performance of solo and small physician practices, such as by aggregating their performance data to create informal practice groups.

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

    Comments: CMS stated that it is working to implement GAO's recommendation to measure the performance of solo and small physician practices. CMS included in its Value Modifier policies the amount of payment adjustments for solo and small physician practices, along with the parameters for measurement. In addition, Congress passed legislation in 2015 requiring CMS to establish a process to allow solo and physician practices under ten eligible professionals to be measured in a virtual group, and the agency is replacing the Value Modifier with a new merit-based incentive payment system. CMS's efforts may, in time, address GAO recommendations to reliably measure the performance of solo and small physician practices, but they have yet to be fully implemented. As of August 2017, CMS officials have not implemented this recommendation. GAO considers it to be open. We will update the status of this recommendation when we receive additional information.
    Director: King, Kathleen M
    Phone: (202) 512-7114

    1 open recommendations
    including 1 priority recommendation
    Recommendation: In order to promote greater use of effective prepayment edits and better ensure proper payment, and to promote implementation of effective edits based on national policies, the CMS Administrator should develop written procedures to provide guidance to agency staff on all steps in the processes for developing and implementing edits based on national policies, including (1) time frames for taking corrective actions, (2) methods for assessing the effects of corrective actions, and (3) procedures for ensuring consideration of automated edits whenever possible, including for all existing NCDs and other national policies.

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

    Comments: HHS concurred with this recommendation. CMS developed written procedures in November 2012 to provide guidance to agency staff on procedures for ensuring consideration of automated edits whenever possible, as GAO recommended in November 2012, but these procedures do not include several key elements of GAO's recommendation. For example, the written procedures do not include time frames for making decisions on whether an edit will be developed for all existing National Coverage Determinations (NCD) and national policies. The written procedures also do not include requirements for methods to assess the effects of corrective actions taken. Implementing a comprehensive written process for developing edits for national policies could help ensure that edits are implemented whenever possible to reduce improper payments. As of September 2017, CMS had not provided us updated documentation that addressed these aspects of our recommendation. Once received, we will review the information and update this recommendation accordingly.
    Director: Powner, David A
    Phone: (202) 512-9286

    1 open recommendations
    Recommendation: The Secretaries of Homeland Security and Health and Human Services should direct their Chief Information Officers to ensure OAs are performed annually on all major steady state investments and the assessments include all key factors.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: We are waiting for HHS's fiscal year 2016 OAs.
    Director: Cosgrove, James C
    Phone: (202)512-7029

    3 open recommendations
    including 3 priority recommendations
    Recommendation: In order to improve CMS's ability to identify self-referred advanced imaging services and help CMS address the increases in these services, the Administrator of CMS should insert a self-referral flag on its Medicare Part B claims form and require providers to indicate whether the advanced imaging services for which a provider bills Medicare are self-referred or not.

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

    Comments: HHS did not concur with this recommendation, noting that CMS did not think this recommendation would be effective in addressing overutilization resulting from self-referral and that it would be complex to administer. We continue to believe that such a flag on Part B claims would likely be the easiest and most cost-effective way for CMS to identify self-referred advanced imaging services and monitor the behavior of those providers who self-refer these services even though the agency has no plans to take further action. As of October 2016, CMS has not provided any additional information about actions to address this recommendation.
    Recommendation: In order to improve CMS's ability to identify self-referred advanced imaging services and help CMS address the increases in these services, the Administrator of CMS should determine and implement a payment reduction for self-referred advanced imaging services to recognize efficiencies when the same provider refers and performs a service.

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

    Comments: HHS did not concur with this recommendation, noting that CMS did not believe that a payment reduction would address overutilization that occurs as a result of self-referral and that the agency's multiple procedure payment reduction policy for advanced imaging already captures efficiencies inhering in providing multiple advanced imaging services by the same physician. Further, CMS officials stated that providers in self-referring arrangements could avoid this reduction by having one provider refer an advanced imaging service while having another perform the service. Finally, CMS questioned whether implementing our recommendation would violate the Medicare statute prohibiting paying a differential by physician specialty for the same service. Our recommendation, however, refers to specific self-referral arrangements in which the same provider refers and performs an imaging service, and therefore would not be addressed by CMS's multiple procedure payment reduction policy. As noted in our report, this payment reduction would affect about 10 percent of advanced imaging services referred by self-referring providers. In addition, while CMS raised questions about whether implementing our recommendation would violate Medicare's prohibition on paying a differential by physician specialty for the same service, the agency did not indicate how it would do so as of October 2016. We continue to believe that CMS should determine and implement a payment reduction to recognize efficiencies for advanced imaging services referred and performed by the same provider even though, as of October 2016, the agency has no plans to take further action.
    Recommendation: In order to improve CMS's ability to identify self-referred advanced imaging services and help CMS address the increases in these services, the Administrator of CMS should determine and implement an approach to ensure the appropriateness of advanced imaging services referred by self-referring providers.

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

    Comments: HHS noted that it would consider this recommendation. The Secretary of HHS has the authority to establish a program to promote the use of appropriate use criteria - criteria that are evidenced-based (to the extent feasible) and that assist professionals to make the most appropriate treatment decisions for a specified clinical condition - for advanced imaging services under the Protecting Access to Medicare Act of 2014. CMS has begun developing its appropriate use criteria program (e.g., in November 2015, CMS established criteria to identify Qualified Provider Led Entities that are responsible for developing appropriate use criteria and has since selected Qualified Provider Led Entities), but full implementation of the program will not occur until at least January 1, 2018. If it - and the subsequent prior authorization program that incorporates appropriate use criteria - are implemented broadly enough (i.e., they ensure the appropriateness of advanced imaging services by all physicians, including those who self-refer), we could close the recommendation.
    Director: Cha, Carol
    Phone: (202) 512-3000

    1 open recommendations
    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: The Department of Health and Human Services has not implemented this recommendation, or provided a plan to do so. As of August 2017, 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
    Director: Cosgrove, James C
    Phone: (202)512-7029

    1 open recommendations
    including 1 priority recommendation
    Recommendation: To increase D-SNPs' accountability and ensure that CMS has the information it needs to determine whether D-SNPs are providing the services needed by dual-eligible beneficiaries, especially those who are most vulnerable, the Administrator of CMS should conduct an evaluation of the extent to which D-SNPs have provided sufficient and appropriate care to the population they serve, and report the results in a timely manner.

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

    Comments: As of October 2016, HHS has not implemented this recommendation. CMS noted that, in 2012, they conducted two independent reviews to evaluate how well SNPs, including D-SNPs, developed and implemented a quality improvement tool used to ensure that the unique needs of SNP enrollees are identified and addressed through the plan's care management practices. However, CMS has not conducted an evaluation of the extent to which D-SNPs have provided sufficient and appropriate care to the population they serve. In prior updates, CMS officials said that they were uncertain whether an evaluation of D-SNPs would be conducted in the future, since the likelihood of an evaluation would be dependent on availability of funding for an independent contract. However, they noted that, to the extent that CMS is able to develop solid care coordination outcome measures (which would be incorporated into the HEDIS requirements), that they expect these measures will serve as key indicators of D-SNP performance. For this recommendation to be closed as implemented, CMS will need to conduct an evaluation of the extent to which D-SNPs have provided sufficient and appropriate care to the population they serve.
    Director: King, Kathleen M
    Phone: (202)512-5154

    1 open recommendations
    Recommendation: In order for CMS to implement an option for removing SSNs from Medicare cards, the Administrator of CMS should develop an accurate, well-documented cost estimate for such an option using standard cost-estimating procedures.

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

    Comments: The Medicare Access and CHIP Reauthorization Act of 2015, signed into law on April 16, 2015, required the Secretary of Health and Human Services, in consultation with the Commissioner of Social Security, to develop and implement an identifier for the Medicare card that is not related to or derived from a beneficiary's Social Security Number. As part of the President's fiscal year 2017 budget proposal, the Centers for Medicare & Medicaid Services (CMS) stated that it had begun the process of removing Social Security Numbers from Medicare cards and will replace them with randomly generated Medicare Beneficiary Identifiers. According to the CMS statement, in the course of initial planning efforts, the agency realized that it will need to re-evaluate the assumptions used to develop the cost estimate for replacing the old Medicare identification numbers, which were derived from Social Security Numbers. As of May 2016, HHS officials reported that they have not implemented this recommendation. GAO considers it to be open. Until CMS develops an accurate, well-developed cost estimate for implementing the Medicare Beneficiary Identifier using standard cost-estimating procedures, we will leave this recommendation open.
    Director: Shames, Lisa R
    Phone: (202) 512-3841

    1 open recommendations
    Recommendation: To strengthen FDA's process for ordering recalls, the Secretary of Health and Human Services should direct the Commissioner of FDA to document FDA's process for ordering food recalls in regulations or industry guidance to include information on how the agency will weigh evidence on whether a recall is necessary.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In May 2015, FDA published a notice in the Federal Register announcing that draft guidance for industry on mandatory food recalls was available for public comment. According to FDA officials, a review of public comments has been completed and finalization of the guidance is pending. We will continue to monitor FDA's efforts to finalize this guidance. (As of February 2017, we continue to await agency action.)
    Director: King, Kathleen M
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: To make IHS's allocation of CHS program funds more equitable, the Secretary of Health and Human Services should direct the Director of the Indian Health Service to require IHS to use actual counts of CHS users, rather than all IHS users, in any formula for allocating CHS funds that relies on the number of active users.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of January 2017, 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: To make IHS's allocation of CHS program funds more equitable, the Secretary of Health and Human Services should direct the Director of the Indian Health Service to require IHS to use variations in levels of available hospital services, rather than just the existence of a qualifying hospital, in any formula for allocating CHS funds that contains a hospital access component.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of January 2017, 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: To make IHS's allocation of CHS program funds more equitable, the Secretary of Health and Human Services should direct the Director of the Indian Health Service to develop written policies and procedures to require area offices to notify IHS when changes are made to the allocations of funds to CHS programs.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of January 2017, 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.
    Director: Melvin, Valerie C
    Phone: (202) 512-6304

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

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

    Comments: In commenting on our report, the Department of Health and Human Services neither agreed nor disagreed with our recommendations. However, in response to this recommendation, FDA officials developed an integrated master schedule (IMS) for the Mission Accomplishment and Regulatory Compliance System, along with corresponding sub-project schedules. The officials also provided explanations of their approach for updating the schedules and estimating resources that are reflected in the schedules, and evidence that the agency is updating the schedule regularly. However, the IMS did not identify all legacy systems to be replaced, did not trace all tasks and contractor subproject schedules, and did not include information reflecting the use of government resources. In 2016, we requested that FDA provide an update on their efforts to address these limitations. As of September 2017, the agency restructured MARCS into two projects and notified us that it was working to establish an IMS for each. FDA officials expect to complete the schedules by the end of calendar year 2017. Until FDA takes steps to address the noted deficiencies, it will lack key information needed for determining what work remains and for identifying and addressing potential problems, thus increasing risks to the success of the agency's modernization efforts. We will continue to work with the Department to address this recommendation.
    Recommendation: To help ensure the success of FDA's modernization efforts, the Commissioner of FDA should direct the CIO to monitor progress of MARCS against the integrated master schedule IMS.

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

    Comments: In commenting on the report, the Department of Health and Human Services neither agreed nor disagreed with our recommendations. However, in response to this recommendation, FDA officials provided a baseline schedule, integrated master schedule (IMS), and sub-project schedules intended to be used to monitor progress of the agency's efforts to implement changes to the Mission Accomplishment and Regulatory Compliance System (MARCS). Nonetheless, while the IMS is updated regularly, it contains data anomalies, and FDA has not documented reasons for changes to the schedule. Consequently, the schedule does not include complete and reliable information needed for monitoring progress of the system investment. As of September 2017, the agency restructured MARCS into two projects and notified us that it was working to establish an IMS for each. FDA officials expect to complete the schedules by the end of calendar year 2017, and to use the schedules to continually monitor the status of the projects. Until FDA takes steps to address deficiencies noted in the IMS for MARCS, it will continue to lack key data needed to monitor progress of the implementation of the system, and increase the risks of this key component of the agency's modernization efforts. We will continue to work with the Department to address this recommendation.
    Director: King, Kathleen M
    Phone: (202)512-3000

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

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

    Comments: As of September 2017, CMS reported that it was still in the process of implementing this recommendation about developing guidance regarding liability and no-fault set-aside arrangements. CMS reported that in February 2017, the agency issued instructions to its contractors confirming that CMS' shared systems will offer functionality to annotate liability insurance and no-fault insurance Medicare set-aside arrangements and that this functionality will be available no later than October 2017. However, CMS officials told us that they were still in the process of developing sub-regulatory guidance about liability and no-fault set-aside arrangements that could be used by other stakeholders, such as insurers and attorneys, and that they were unsure when this guidance would be finalized and distributed to those stakeholders
    Director: Cosgrove, James C
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: The Administrator of CMS should take steps to better align Medicare beneficiary use of preventive services with Task Force recommendations, including providing coverage of services with an 'A" or 'B" grade for the recommended population and at the recommended frequency, as she determines is appropriate considering cost-effectiveness and other criteria.

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

    Comments: CMS has noted that it extended Medicare coverage for several additional preventive services, and that it continues to review the Task Force's recommendations. However, while CMS has added new preventive services, the GAO report calls on CMS to provide Medicare coverage consistent with Task Force recommended services, for the specific recommended population and at the recommended frequency. For example, the Task Force has recommended that all women age 65 and over receive bone mass measurement to screen for osteoporosis, but Medicare coverage of this service remains limited. As of August 2017, CMS officials have not implemented this recommendation. GAO considers it to be open. We will update the status of this recommendation when we receive additional information.
    Director: Cosgrove, James C
    Phone: (202) 512-7114

    1 open recommendations
    including 1 priority recommendation
    Recommendation: To help ensure appropriate payments to MA plans, the Administrator of CMS should take steps to improve the accuracy of the adjustment made for differences in diagnostic coding practices between MA and Medicare FFS. Such steps could include, for example, accounting for additional beneficiary characteristics, including the most current data available, identifying and accounting for all years of coding differences that could affect the payment year for which an adjustment is made, and incorporating the trend of the impact of coding differences on risk scores.

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

    Comments: CMS noted in the Medicaid Advantage Call Letter of April 2016 that it has extensively analyzed the MA data and determined that the optimal way to apply the adjustment is to do so using the statutory minimum adjustment level of 5.66 percent. However, as of October 2016, CMS had not provided any documentation of its analysis and the basis for its determination. CMS has requested a meeting with GAO to discuss the issues and GAO will meet with CMS. However, until we receive additional information about the actions CMS has taken, this recommendation remains open.
    Director: King, Kathleen M
    Phone: (202)512-5154

    2 open recommendations
    Recommendation: To develop more accurate data for estimating the funds needed for the CHS program and improving IHS oversight, the Secretary of Health and Human Services should direct the Director of IHS to develop a written policy documenting how IHS evaluates need for the CHS program and disseminate it to area offices and CHS programs to ensure they understand how unfunded services data are used to estimate overall program needs.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In response to this recommendation, IHS reported in October 2015 that it was completing a comprehensive update of a policy chapter related to the Contract Health Services (CHS) Program (also called the Purchased/Referred Care Program). The agency indicated that this revised chapter would incorporate a written policy on how IHS evaluates need for the CHS program. It indicated that the chapter update had been under revision since December 20, 2012, with final approval anticipated in 2015. In July 2017, IHS indicated that the policy was still under development and would be issued to all IHS sites by September 30, 2017.
    Recommendation: To develop more accurate data for estimating the funds needed for the CHS program and improving IHS oversight, the Secretary of Health and Human Services should direct the Director of IHS to provide written guidance to CHS programs on a process to use when funds are depleted and there is a continued need for services, and monitor to ensure that appropriate actions are taken.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In response to this recommendation, IHS reported in October 2015 that it developed and distributed Fund Management Standardization guidance to Area Offices to monitor compliance by federal Contract Health Services (CHS) program (also called the Purchased/Referred Care program) Service Units. Also, IHS issued standardized spending plan procedures to all Area Offices and Federally-operated programs. Also, it indicated that spending plan guidance would be included in an update of a policy chapter related to the CHS program. The agency indicated that this chapter had been under revision since December 20, 2012, with final approval anticipated in 2015. In July 2017, IHS indicated that the policy was still under development and would be issued to all IHS sites by September 30, 2017.
    Director: Kohn, Linda T
    Phone: (202)512-3000

    2 open recommendations
    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.
    Director: Draper, Debra A
    Phone: (202) 512-3000

    2 open recommendations
    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.
    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.
    Director: Melvin, Valerie C
    Phone: (202)512-6304

    2 open recommendations
    Recommendation: To help ensure that the development and implementation of IDR and One PI are successful in helping the agency meet the goals and objectives of its program integrity initiatives, the Administrator of CMS should implement and manage plans for incorporating data in IDR to meet schedule milestones.

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

    Comments: While CMS has incorporated shared systems Medicare Part A (insurance for hospital and other inpatient services), Part B (insurance for hospital outpatient, physician, and other services), and three states' Medicaid data into IDR, it has not yet implemented and managed plans for incorporating all states' Medicaid data, as GAO recommended in June 2011. As a result, the repository does not yet include all the data that were planned to be incorporated by the end of 2012, and efforts to add the remaining states' Medicaid data to IDR continue to be behind schedule. As of March 2017, agency officials are working to develop plans to integrate all states' data into IDR as part of ongoing program integrity initiatives.
    Recommendation: To help ensure that the development and implementation of IDR and One PI are successful in helping the agency meet the goals and objectives of its program integrity initiatives, the Administrator of CMS should define any measurable financial benefits expected from the implementation of IDR and One PI.

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

    Comments: As of March 2017, CMS officials reported that they have identified areas of potential cost savings to be achieved by requiring program integrity contractors to use IDR and One PI, as GAO recommended in June 2011. CMS is awarding new contracts to include this requirement, which is expected to result in the agency no longer funding contractors' efforts to establish and maintain their own data warehouses and analytical tools. However, not all of the contracts have been awarded and, therefore, the requirement has not been fully implemented. Until all the new contracts have been awarded that require the contractors to use IDR and One PI for program integrity purposes, CMS will not have reasonable assurance that using the systems will help improve CMS's ability to detect fraud, waste, and abuse in the Medicare and Medicaid programs, and to achieve the $21 billion in financial benefits program officials projected.
    Director: Shear, William B
    Phone: (202)512-4325

    1 open recommendations
    Recommendation: To more fully evaluate the effectiveness of their mentor-protege programs, the OSDBU and Mentor-Protege Program Directors of DHS, DOE, DOS, EPA, FAA, GSA, HHS, SBA, Treasury, and VA should consider collecting and maintaining protege postcompletion information.

    Agency: Department of Health and Human Services: Office of Small and Disadvantaged Business Utilization
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Dicken, John E
    Phone: (202)512-7043

    6 open recommendations
    Recommendation: To ensure that information entered into CMS's complaints database is reliable and consistent, the Administrator of CMS should identify issues with data quality and clarify guidance to states about how particular fields in the database should be interpreted, such as what it means to substantiate a complaint.

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

    Comments: HHS concurred with this recommendation. In November 2014, CMS officials reported that the agency's Survey and Certification Group was in the early stages of a planned multi-year review of all of its business processes, including those related to nursing home complaint investigations. Officials stated that, as part of that review, agency staff would seek to provide clarification on all aspects of the complaint process, including what it means to substantiate a complaint. As of September 2016, CMS officials have not implemented this recommendation. GAO considers it to be open. We will update the status of this recommendation when we receive additional information.
    Recommendation: To strengthen CMS's assessment of state survey agencies' performance in the management of nursing home complaints, the Administrator of CMS should conduct additional monitoring of state performance using information from CMS's complaints database, such as additional timeliness measures.

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

    Comments: In November 2014, CMS officials reported that the fiscal year 2014 protocol for assessment of state agency performance includes a new measure that tracks how soon after the completion of a complaint investigation a state agency uploads data from that investigation to CMS's complaint tracking system. However, the protocol does not call for assessment of the number of days by which state survey agencies miss the deadlines for some complaint investigations--a measure that we suggested could provide a more comprehensive picture of state agency performance. As of September 2016, CMS officials have not implemented this recommendation. GAO considers it to be open. We will update the status of this recommendation when we receive additional information.
    Recommendation: To strengthen CMS's assessment of state survey agencies' performance in the management of nursing home complaints, the Administrator of CMS should assure greater consistency in assessments by identifying differences in interpretation of the performance standards and clarifying guidance to state survey agencies and CMS regional offices.

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

    Comments: HHS agreed that CMS needed to strengthen its assessment of state survey agencies' performance in the management of nursing home complaints. In November 2014, CMS officials reported that the agency's fiscal year 2014 protocol for assessment of state agencies' performance requires CMS regional offices to review the extent to which the states' policies are consistent with CMS policies. CMS officials acknowledged that there was some variation among states and noted that the agency's Survey and Certification Group is in the early stages of a multi-year review of all of its business processes. Officials expected this review would identify additional opportunities to improve consistency among states in the application of the performance standards. As of September 2016, CMS officials have not implemented this recommendation. GAO considers it to be open. We will update the status of this recommendation when we receive additional information.
    Recommendation: To strengthen and increase accountability of state survey agencies' management of the nursing home complaints process, the Administrator of CMS should clarify guidance to the state survey agencies about the minimum information that should be conveyed to complainants at the close of an investigation.

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

    Comments: HHS agreed that CMS needed to take steps to strengthen and increase accountability of state survey agencies' management of nursing home complaints. In November 2014, CMS officials reported that while they believed the CMS State Operations Manual, which specifies procedures for addressing complaints, provides significant guidance regarding the information that state agencies should convey to complainants at the close of an investigation, they would review the guidance to identify any needed changes. As of September 2016, CMS officials have not implemented this recommendation. GAO considers it to be open. We will update the status of this recommendation when we receive additional information.
    Recommendation: To strengthen and increase accountability of state survey agencies' management of the nursing home complaints process, the Administrator of CMS should provide guidance encouraging state survey agencies to prioritize complaints at the level that is warranted, not above that level.

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

    Comments: HHS agreed that CMS needed to take steps to strengthen and increase accountability of state survey agencies' management of the nursing home complaints process and stated that CMS would provide clarification and guidance to states to ensure complaints were prioritized at the appropriate level. However, in CMS's fiscal year 2014 protocol for assessment of state agency performance, the prioritization standard still required only that complaints be assigned a priority level at or above the level assigned by CMS reviewers. We remain concerned that defining the standard this way may create an incentive for survey agencies to prioritize some complaints at a higher level than is warranted--which could increase workload and potentially jeopardize the timeliness of investigations that warrant the higher priority level. As of September 2016, CMS officials have not implemented this recommendation. GAO considers it to be open. We will update the status of this recommendation when we receive additional information.
    Recommendation: To strengthen and increase accountability of state survey agencies' management of the nursing home complaints process, the Administrator of CMS should implement CMS's proposed plans to publish state survey agencies' scores but limit publication to those performance standards that CMS considers the most reliable and clear.

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

    Comments: HHS agreed that CMS needed to take steps to strengthen and increase accountability of state survey agencies' management of the nursing home complaints process and said that CMS would work with state officials and others to identify key performance information that would be of public value. In November 2014, CMS officials reported that the agency had not yet outlined a method or timetable for publishing states' performance scores. As of September 2016, CMS officials have not implemented this recommendation. GAO considers it to be open. We will update the status of this recommendation when we receive additional information.
    Director: Iritani, Katherine M
    Phone: (206)287-4820

    2 open recommendations
    Recommendation: In light of the need for accurate and complete information on children's access to health services under Medicaid and CHIP, the requirement that states report information to CMS on certain aspects of their Medicaid and CHIP programs, and problems with accuracy and completeness in this state reporting, the Administrator of CMS should establish a plan, with goals and time frames, to review the accuracy and completeness of information reported on the CMS 416 and CHIP annual reports and ensure that identified problems are corrected.

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

    Comments: In September 2016, CMS said that it was taking new steps to review data on children's access and quality of care by reviewing required reports that evaluate states' Medicaid managed care plans; however, these reports do not represent a consistent set of measures used by all states that CMS can use for oversight purposes. Accurate, complete, and reliable data for both Medicaid and CHIP are necessary for CMS's oversight of children's access to services. GAO considers this recommendation open.
    Recommendation: In light of the need for accurate and complete information on children's access to health services under Medicaid and CHIP, the requirement that states report information to CMS on certain aspects of their Medicaid and CHIP programs, and problems with accuracy and completeness in this state reporting, the Administrator of CMS should work with states to identify additional improvements that could be made to the CMS 416 and CHIP annual reports, including options for reporting on the receipt of services separately for children in managed care and fee-for-service delivery models, while minimizing reporting burden, and for capturing information on the CMS 416 relating to children's receipt of treatment services for which they are referred.

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

    Comments: In September 2016, CMS said that it had changed the instructions for completing the CMS 416 to provide more detailed guidance for states on capturing required information on the total number of children who were referred for treatment services. However, CMS is not planning to require states to submit information on whether children received the treatment services for which they were referred. We maintain that having ability to monitor receipt of treatment services, receipt of services in managed care separate from fee-for-service, and having data from all states is important to CMS oversight. GAO considers this recommendation open.
    Director: Cosgrove, James C
    Phone: (202)512-7029

    2 open recommendations
    Recommendation: To help ensure that Medicare beneficiaries have access to high-quality dialysis care, the Administrator of CMS should assess the extent to which the bundled payment for dialysis care will be sufficient to cover an efficient dialysis organization's costs to provide such care when the bundled payment expands to cover oral-only ESRD drugs. The Administrator should conduct this assessment before implementing this expanded bundled payment.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: In order to ensure effective monitoring of treatment of mineral and bone disorder, the Administrator of CMS should continue collecting data for quality measures related to this condition from sources such as the Elab Project until CROWNWeb is fully implemented and concerns about its data reliability have been adequately addressed.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Cosgrove, James C
    Phone: (202)512-7029

    1 open recommendations
    Recommendation: To establish rates that more accurately reflect the distinct costs of providing each type of home oxygen equipment, the Administrator of CMS should restructure Medicare's home oxygen payment methodology. This should include removing the payment for portable oxygen refills from that for stationary equipment and paying for refills only for the equipment types that require them.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Iritani, Katherine M
    Phone: (206)287-4820

    2 open recommendations
    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 establish a process to periodically verify that the dentist lists posted by states on the Insure Kids Now Web site are complete, usable, and accurate, and ensure that states and participating dentists have a common understanding of what it means for a dentist to indicate he or she can treat children with special needs.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS has reported taking steps to improve the data on the Insure Kids Now website, including establishing an ongoing system to check that data are in the correct format and conducting validation surveys. HHS has also reported that CMS will provide technical assistance to low performing States and develop mechanisms to better identify providers that serve children with special health care needs. As of September 2017, CMS has not indicated that it has communicated with states and providers on what it means for a dentist to indicate he or she can treat children with special needs. We will leave this recommendation open until the agency takes steps to ensure that states and participating dentists have a common understanding of what it means for a dentist to indicate he or she can treat children with special needs.
    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 2017, CMS has not indicated the agency has required states to ensure that excluded providers are not listed on the Insure Kids Now website and has not indicated that the agency has taken steps to periodically verify that excluded providers are not listed. 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.
    Director: Crosse, Marcia G
    Phone: (202)512-3407

    1 open recommendations
    Recommendation: To help ensure that FDA's overseas offices are able to fully meet their mission of helping to ensure the safety of imported products, the Commissioner of FDA should ensure, as it completes its strategic planning process for the overseas offices, that it develops a set of performance goals and measures that can be used to demonstrate overseas office contributions to long-term outcomes related to the regulation of imported products and that overseas office activities are coordinated with the centers and Office of Regulatory Affairs (ORA).

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

    Comments: In August 2017, FDA reported that it remains committed to strengthening its efforts and systematically monitoring and evaluating the overseas offices' contributions to the agency's mission and objectives. FDA also stated that it is making significant progress in several areas by enhancing strategic planning and analysis, refining the Office of International Program's (OIP) performance metrics, and designing a monitoring and evaluation plan. For example, FDA stated it has developed a framework with refined performance metrics to distinguish and assess the distinct contribution of OIP and its foreign offices towards program objectives and broader agency goals. FDA said that the performance metrics will track and monitor the quantity, quality, and timeliness of activity outputs and intermediate outcomes resulting from OIP's work. The measures have been standardized and defined, and will be further disaggregated to enable various levels of analyses, including distinguishing the unique efforts by foreign offices and product type. According to FDA, it plans to roll out its performance framework, related metrics, and monitoring and evaluation processes in fiscal year 2018. FDA said it anticipates that its performance measures, enhanced monitoring, and increased sharing of best practices across foreign offices and FDA headquarters will facilitate tracking of performance, allow greater accountability, and provide a foundation for continuous improvement. GAO will continue to monitor FDA's progress.
    Director: Cosgrove, James C
    Phone: (202)512-7029

    1 open recommendations
    Recommendation: To help ensure that changes in Medicare payment methods for dialysis care do not adversely affect beneficiaries, the Administrator of CMS should monitor the access to and quality of dialysis care for groups of beneficiaries, particularly those with above average costs of dialysis care, under the new bundled payment system. Such monitoring should begin as soon as possible once the new bundled payment system is implemented and be used to inform potential refinements to the payment system.

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

    Comments: In March 2010, we recommended that the Administrator of CMS monitor the access to and quality of dialysis care for groups of beneficiaries, particularly those with above average costs, under the new bundled payment system to help ensure that changes in the Medicare payment methods for dialysis care do not adversely affect. We further specified that such monitoring begin as soon as possible once the new bundled payment system is implemented. CMS implemented the expanded bundled payment system for dialysis care in January 2011. As of August 2011, CMS is collecting data on dialysis care utilization that could be used to examine access to and quality of dialysis care by groups of beneficiaries. Although CMS anticipates using these data to identify potential problems in dialysis care, the agency has not begun using these data to examine access to and quality of care by groups of beneficiaries, nor has finalized plans to do so.
    Director: Shames, Lisa R
    Phone: (202) 512-2649

    2 open recommendations
    Recommendation: To better ensure FDA's oversight of the safety of GRAS substances, the Commissioner of FDA should develop a strategy to minimize the potential for conflicts of interest in companies' GRAS determinations, including taking steps such as issuing guidance for companies on conflict of interest and requiring information in GRAS notices regarding expert panelists' independence.

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

    Comments: In September 2014, FDA indicated that guidance on potential conflicts of interest for experts participating on GRAS panels is a priority for the agency. In its Final Rule on Substances Generally Recognized as Safe (81 FR 54959), issued Aug. 17, 2016, FDA stated that it had decided to issue guidance regarding conflicts of interest and that it would announce the availability of a draft guidance document through a notice in the Federal Register. As of December 2016, FDA had not yet issued this draft guidance.
    Recommendation: To better ensure FDA's oversight of the safety of GRAS substances, the Commissioner of FDA should develop a strategy to monitor the appropriateness of companies' GRAS determinations through random audits or some other means, including issuing guidance on how to document GRAS determinations.

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

    Comments: On Aug. 17, 2016, FDA published a final rule on Substances Generally Recognized as Safe (GRAS) (81 FR 54959). This final rule includes a section titled "Guidance on Documenting Conclusions of GRAS Status," which states that FDA is "issuing a guidance" for companies on how to document their GRAS determinations. It is not clear from the rule the time frame for issuing this guidance, whether it will be issued in draft first for comment, and whether it will part of the guidance on conflicts of interest that FDA also plans to issue at a later date, as noted elsewhere in the rule. As of December 2016, FDA had not issued this guidance.
    Director: Dicken, John E
    Phone: (202)512-7043

    2 open recommendations
    Recommendation: To address state agency practices and external pressure that may compromise survey accuracy, the Administrator of CMS should reestablish expectations through guidance to state survey agencies that noncitation practices--official or unofficial--are inappropriate, and systematically monitor trends in states' citations.

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

    Comments: September 2017: HHS reported CMS is working to address this recommendation. We will update the status of this recommendation when we receive further information. September 2016: CMS has not yet provided additional information. GAO will update the recommendation, as appropriate, when information is received. July 2015: CMS indicated it will provide GAO with updated actions in early 2016. May 2014: Though the best method to address external pressures on State Agencies was not identified, CMS is continuing to address the consistency, effectiveness, and integrity of the survey process through the following activities: reviewing citation patterns for the nursing home surveys; systematically identifying and testing opportunities to make the survey process more efficient and effective; and holding monthly CO and RO calls to address consistencies in the survey and enforcement process. CMS Regional Offices also routinely hold conference calls (e.g., monthly) with the State Survey Agencies in their region to address survey, enforcement and certification issues and conduct the federal validation survey of the state's findings. CMS is looking to review specific regulatory deficiencies for trends and areas where additional guidance is needed. Anticipated completion date of October 31, 2014. June 2013: Though the best method to address external pressures on State Agencies was not identified. CMS is continuing to address the consistency, effectiveness, and integrity of the survey process through the following activities: reviewing citation patterns for the nursing home surveys; systematically identifying and testing opportunities to make the survey process more efficient and effective; and holding monthly CO and RO calls to address consistencies in the survey and enforcement process. CMS Regional Offices also routinely hold conference calls (e.g., monthly) with the State Survey Agencies in their region to address survey, enforcement and certification issues and conduct the federal validation survey of the state's findings. September 2010: CMS held a State/Federal meeting in April 2010. The discussion with the State/Federal meeting did not shed light on best method to address possible external pressures on State Agencies. Some expressed that poor documentation/inadequate investigation may cause deficiencies to be dropped and not necessarily external pressure. They will continue to work on developing next steps.
    Recommendation: To address state agency practices and external pressure that may compromise survey accuracy, the Administrator of CMS should establish expectations through guidance to state survey agencies to communicate and collaborate with their CMS regional offices when they experience significant pressure from legislators or the nursing home industry that may affect the survey process or surveyors' perceptions.

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

    Comments: September 2017: HHS reported CMS is working to address this recommendation. We will update the status of this recommendation when we receive further information. September 2016: CMS has not yet provided additional information. GAO will update the recommendation, as appropriate, when information is received. July 2015: CMS indicated it will provide GAO with updated actions in early 2016. May 2014: CMS has undertaken a broader review of both the QIS and traditional survey processes, and the extent to which the methodology and guidance result in an effective and efficient survey process. In August 2012, CMS convened a broad group of surveyors to address these issues and make recommendations which have resulted in continuing work to develop and test alternative guidance and processes. CMS is looking to review specific regulatory deficiencies for trends and areas where additional guidance is needed. Anticipated Completion date of December 31, 2014. June 2013: Though the best method to address external pressures on State Agencies was not identified. CMS is continuing to address the consistency, effectiveness, and integrity of the survey process through the following activities: reviewing citation patterns for the nursing home surveys; systematically identifying and testing opportunities to make the survey process more efficient and effective; and holding monthly CO and RO calls to address consistencies in the survey and enforcement process. CMS Regional Offices also routinely hold conference calls (e.g., monthly) with the State Survey Agencies in their region to address survey, enforcement and certification issues and conduct the federal validation survey of the state's findings. September 2010: CMS held a State/Federal meeting in April 2010. The discussion with the State/Federal meeting did not shed light on best method to address possible external pressures on State Agencies. CMS will continue to work on developing next steps.
    Director: Dicken, John E
    Phone: (202)512-7043

    1 open recommendations
    Recommendation: To help ensure the longer-term compliance of nursing homes that have successfully returned to substantial compliance under temporary management, the Administrator of CMS should develop guidance for states to enhance their oversight of such homes, such as implementing reactivation of temporary management if the home does not maintain substantial compliance over the 2 years following the conclusion of the sanction.

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

    Comments: September 2017: CMS provided documentation of training documents developed for State Agency Directors and Enforcement Specialists covering a variety of topics including when to use the temporary management sanction. Neither the new training nor relevant sections of the CFR or State Operations Manual appear to provide guidance on longer-term oversight of nursing homes that have returned to substantial compliance under temporary management. September 2016: GAO has not received additional information from CMS. July 2015: CMS indicated it will provide GAO with updated actions in early 2016. July 2014: CMS said the recommendation was in process and CMS was drafting an internal enforcement action plan to discuss enforcement remedies including temporary management. June 2013: CMS officials said they have been making an effort to work with the Regional Offices and states on the appropriate use of all sanctions in general, including the use of Temporary Management. June 2012: CMS officials said that the agency continues to investigate the various uses of CMP monies and the potential to use CMPs to recruit, train and supervise temporary managers is one of several options under consideration. May 2011: CMS agreed this was an important recommendation, but due to the Affordable Care Act implementation, the agency said they temporarily deferred planned work until 2012.
    Director: Gomez, Jose A
    Phone: (202)512-2649

    1 open recommendations
    Recommendation: To enhance FDA's oversight of dietary supplements and foods with added dietary ingredients, and to better enable FDA to meet its responsibility to regulate dietary supplements that contain new dietary ingredients, the Secretary of the Department of Health and Human Services should direct the Commissioner of FDA to issue guidance to clarify when an ingredient is considered a new dietary ingredient, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing ingredient identity.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In July 2011, FDA published draft guidance for industry on new dietary ingredient notifications and related issues. This draft guidance includes information on when a dietary ingredient is considered new, evidence of safety, and methods for ingredient identity. We are waiting for the draft guidance to become final to close the recommendation.
    Director: Crosse, Marcia G
    Phone: (202)512-3407

    1 open recommendations
    Recommendation: The Secretary of Health and Human Services should direct the FDA Commissioner to expeditiously take steps to issue regulations for each class III device type currently allowed to enter the market through the 510(k) process. These steps should include issuing regulations to (1) reclassify each device type into class I or class II, or requiring it to remain in class III, and (2) for those device types remaining in class III, require approval for marketing through the PMA process.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: FDA has taken steps to respond to this recommendation; however we are leaving the recommendation open because the agency has not yet taken final steps to reclassify or require premarket approval (PMA) for two class III device types allowed to enter the market through the less stringent 510(k) process. In 2009, FDA began a 5-step process to reclassify or to require PMAs for 26 class III device types. This process was modified by the Food and Drug Administration Safety and Innovation Act (FDASIA)--instead of issuing regulations as the final step, FDA issues an administrative order to reclassify or require PMAs for the device types. In 2014, the agency reported it had set a goal to have all remaining devices finalized by the second quarter of 2015; however, as of August 2017, FDA had not finished the process of reclassifying or requiring PMAs for 2 of 26 devices types. The agency reported completing the process for 24 device types, and provided new planned milestones to complete the process for the remaining device types by the middle of 2018. We will leave this recommendation open until FDA makes progress in reclassifying or requiring PMAs for the remaining device types.
    Director: Iritani, Katherine M
    Phone: (202)512-3000

    1 open recommendations
    Recommendation: To improve the oversight of states' Medicaid supplemental payments, the Administrator of CMS should develop a strategy to identify all of the supplemental payment programs established in states' Medicaid plans and to review those programs that have not been subject to review under CMS's August 2003 initiative.

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

    Comments: As of July 2016, HHS officials reported that they have not implemented this recommendation. GAO considers it to be open. We will update the status of this recommendation when we receive additional information.
    Director: Dicken, John E
    Phone: (202)512-7043

    1 open recommendations
    Recommendation: To help states identify and address quality-of-care concerns among individuals with developmental disabilities receiving Medicaid HCBS waiver services, the Administrator of CMS should encourage states to (1) include death as a critical incident and conduct mortality reviews if they do not already do so and (2) broaden their mortality review processes if they already include death as a critical incident and conduct mortality reviews.

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

    Comments: In August 2009, CMS stated that it anticipated adding a question about mortality reviews to its next web-based version of the Home and Community-Based Services waiver application. CMS also indicated at that time that the next application version (i.e., Version 3.6) would be released in 2010. However, in July 2010, CMS indicated that this version would not be produced until 2011. In its 2011 update, CMS indicated that the version 3.6 online application had not yet been operationalized and therefore the recommendation should be left open until next year. In July 2013, CMS stated that version 3.6 remains on hold and that the agency is exploring other options for addressing this recommendation, with a target completion date of 12/31/2014.
    Director: Steinwald, Alan Bruce
    Phone: (202)512-3000

    1 open recommendations
    Recommendation: Given the contribution of physicians to Medicare spending in total, the Administrator of CMS should develop a profiling system that identifies individual physicians with inefficient practice patterns and, seeking legislative changes as necessary, use the results to improve the efficiency of care financed by Medicare. The profiling system should include methods for measuring the impact of physician profiling on program spending and physician behavior.

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

    Comments: Physician feedback reporting was initiated under section 131(c) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), and was expanded by section 3003 of the Patient Protection and Affordable Care Act (PPACA). In addition, PPACA required the Department of Health and Human Services to coordinate the physician feedback program with a Value Modifier (VM) that will adjust fee-for-service physician payments for the relative quality and cost of care provided to beneficiaries. In 2012, CMS provided Quality and Resource Use Reports (QRUR) to large providers nationwide and physician-focused QRURs to groups with 25 or more eligible providers in 9 states; by 2014, CMS sent QRURs to all group practices and solo practitioners. Also, as required in the act, CMS applied the VM to select physicians in 2015, with all physicians being subject to VM by 2017. The Act requires the VM to be implemented in a budget neutral manner, meaning that any upward payment adjustments for high performance must balance the downward payment adjustments applied for poor performance. CMS officials said they develop and will continue to develop experience reports related to each year's QRUR/VM cycle. In 2015, CMS used VM results for physicians in groups of 100 or more in public engagement of stakeholders, encouraging them to report quality, because quality performance was the driver of the payment adjustments in 2015. CMS is working with its Center for Clinical Standards and Quality to think of how to better engage physicians and groups in reporting, to avoid the automatic downward adjustment. As the program gains experience, CMS will use the experience reports to examine the impact of QRURs and VM on the Medicare program. In order for this recommendation to be closed as implemented, CMS will need to expand its efforts to measure the impact of QRURs and VM on program spending and physician behavior.
    Director: Iritani, Katherine M
    Phone: (202)512-3000

    1 open recommendations
    Recommendation: To enhance the transparency of CMS oversight and clarify and communicate the types of allowable state financing arrangements, the Administrator of CMS should provide each state CMS reviews under its initiative with specific and written explanations regarding agency determinations on the allowability of various arrangements for financing the nonfederal share of Medicaid payments and make these determinations available to all states and interested parties.

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

    Comments: As of July 2016, HHS officials reported that they have not implemented this recommendation. GAO considers it to be open. We will update the status of this recommendation when we receive additional information.
    Director: Aronovitz, Leslie G
    Phone: (312)220-7767

    1 open recommendations
    Recommendation: The Administrator of CMS should require the PSCs to develop thresholds for unexplained increases in billing--and use them to develop automated prepayment controls as one component of their manual medical review strategies.

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

    Comments: Despite progress in identifying potentially improper groups of claims by provider, CMS has not developed thresholds for unexplained increases in billing by providers and used them to develop automated prepayment controls, as GAO recommended in January 2007. CMS took action in July 2011 to improve Medicare payment accuracy by introducing predictive analytics to help identify patterns of potentially improper claims and has some other prepayment controls in place. Specifically, the Small Business Jobs Act of 2010 requires CMS to use predictive modeling and other analytic techniques?known as predictive analytic technologies?to identify improper claims and prevent improper payments under the Medicare fee-for-service program. CMS is streaming every Medicare fee-for-service claim through a predictive modeling technology system, known as the Fraud Prevention System (FPS), prior to payment. The FPS uses a series of algorithms to identify potentially fraudulent claims. As each claim streams through the FPS, the system builds profiles of providers, networks, and billing patterns. Using these profiles, CMS estimates a claim's likelihood of being fraudulent and prioritizes providers with the most suspicious groups of claims for further investigation. CMS also has other prepayment controls in place, for example, to identify duplicate billing. As of December 2015, CMS did have algorithms in FPS to flag providers with unexpected increases in billings for investigation. CMS also instituted prepayment controls that can deny a claim before payment, however these controls are related to Medicare coverage requirements and do not address the issue of large increases in provider billing. Prepayment controls can suspend claims processing or deny claims before claims are paid, which would provide a greater assurance that Medicare funds are not going to potentially fraudulent providers. As of August 2016, HHS officials reported that they have not implemented this recommendation. GAO considers it to be open. We will update the status of this recommendation when we receive additional information.
    Director: King, Kathleen M
    Phone: (312)220-7767

    1 open recommendations
    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's Health Resources and Services Administration (HRSA)is working with State Primary Care Offices (PCOs) to collect data to determine which geographic areas, population groups, and facilities are qualified and suitable to receive federal shortage designations. As part of this process, HRSA plans to have a list of the J-1 visa waiver providers who are providing patient care in underserved areas available after December 2016. As of September 2016, we are leaving this recommendation open until HRSA finishes collecting these data and finalizes plans on how the data will be used, particularly when identifying areas experiencing physician shortages and placing physicians in these areas.
    Director: Iritani, Katherine M
    Phone: (202)512-7059

    1 open recommendations
    including 1 priority recommendation
    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: HHS has generally disagreed with this recommendation. However, we have reiterated the need for increased attention to the fiscal responsibility in the approval of the section 1115 Medicaid demonstrations in subsequent 2008 and 2013 reports (GAO-08-87 and GAO-13-384). Although HHS has not issued a written budget neutrality policy as of October 2016, it has taken steps to change some aspects of methods states can use to determine budget neutrality and demonstration spending limits. The new methods are intended to result in more appropriate demonstration spending limits. For example, according to CMS officials, starting in May 2016, the agency began reducing the amount of accumulated savings that states can carryover when demonstrations are renewed, which was previously unlimited. We are continuing to monitor the effect of the recent changes. The recent changes did not address all of the questionable methods we have identifed in our reports.