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    Results:

    Subject Term: Health

    20 publications with a total of 43 open recommendations including 2 priority recommendations
    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: Farrell, Brenda S
    Phone: (202)512-3604

    2 open recommendations
    Recommendation: To provide decision makers with more-complete information on the planned implementation, management, and oversight of DOD's newly created DHA, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to develop and present to Congress a comprehensive timeline that includes interim milestones for all reform goals that could be used to show implementation progress.

    Agency: Department of Defense
    Status: Open

    Comments: As of September 2015, DOD has not submitted a comprehensive timeline that includes interim milestones for all reform goals. Further, as we reported in September 2015, DOD's plan for assessing the personnel requirements of the DHA lacks a detailed timeline with milestones and interim steps. Until DOD develops a comprehensive timeline for its reform, this recommendation should remain open. June 2017 Update: The DHA strategic plan/CONOPS showing a comprehensive timeline for all of its reform goals has yet to be released.
    Recommendation: To provide decision makers with more-complete information on the planned implementation, management, and oversight of DOD's newly created DHA, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to monitor implementation costs to assess whether the shared-services projects are on track to achieve projected net cost savings or if corrective actions are needed.

    Agency: Department of Defense
    Status: Open

    Comments: As we reported in September 2015, DOD has taken some action on this recommendation for 8 of its 10 shared services. The DHA's internal leadership briefings now identify the major types of implementation costs where relevant, or otherwise address their potential impact. For example, information technology costs are identified as one primary type of costs for the Health Information Technology and Medial Logistics shared services, while contract costs are identified for the Budget and Resource Management, Medical Logistics, and Health Information Technology shared services. By identifying the major types of implementation costs, decision makers are better able to gauge the sensitivity of areas of uncertainty as they make decisions concerning future investments in shared services. MAY 2016 UPDATE: DHA reported and we verified financial savings of $722 million for FY14 and FY15 due to shared services implementation. June 2017 Update: DHA reported and we verified financial savings of $686.6 million for FY 16 due to shared services implementation.
    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: Gootnick, David B
    Phone: (202) 512-3149

    2 open recommendations
    Recommendation: In order to improve the ability of the U.S. agencies participating in the Joint Economic Management Committee (JEMCO) and Joint Economic Management and Financial Accountability Committee (JEMFAC) to conduct required oversight of compact funds, the Secretary of the Interior should direct the Director of Insular Affairs, as Chairman of JEMCO, to coordinate with other JEMCO-member U.S. agencies to have JEMCO take all necessary steps, or, as the administrator of compact grants, to directly take all necessary steps, to ensure that the FSM (1) completes satisfactory plans to address annual decrements in compact funds, (2) produces reliable indicator data used to track progress in education and health, and (3) addresses all single audit findings in a timely manner.

    Agency: Department of the Interior
    Status: Open

    Comments: JEMCO accepted decrement plans from the FSM which addressed one element of the recommendation. However, as of June 16th, 2017 the other parts of the recommendation have not been addressed.
    Recommendation: In order to improve the ability of the U.S. agencies participating in the JEMCO and JEMFAC committees to conduct required oversight of compact funds, the Secretary of the Interior should direct the Director of Insular Affairs, as Chairman of the JEMFAC, to coordinate with other JEMFAC-member U.S. agencies to have JEMFAC take all necessary steps, or, as the administrator of compact grants, to directly take all necessary steps, to ensure that the RMI (1) completes satisfactory plans to address annual decrements in compact funds, (2) produces reliable indicator data used to track progress in education and health, and (3) addresses all single audit findings in a timely manner.

    Agency: Department of the Interior
    Status: Open

    Comments: JEMFAC accepted decrement plans from the RMI, which addressed one element of the recommendation. However, as of June 16th, 2017 the other parts of the recommendation have not been addressed.
    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: Cosgrove, James C
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: To increase beneficiaries' awareness of providers' financial interest in a particular treatment, Congress should consider directing the Secretary of Health and Human Services to require providers who self-refer IMRT services to disclose to their patients that they have a financial interest in the service.

    Agency: Congress
    Status: Open

    Comments: In August 2013, to increase beneficiaries' awareness of providers' financial interest in a particular treatment, we suggested that Congress should consider directing the Secretary of Health and Human Services to require providers who self-refer IMRT services to disclose to their patients that they have a financial interest in the service. As of June 2017, Congress has not implemented this suggestion.
    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: St James, Lorelei
    Phone: (202) 512-2834

    4 open recommendations
    Recommendation: A key matter for Congress to consider is whether or not to move forward with a USPS health plan that would result in an increase in retirees' use of Medicare. If Congress decides to approve this proposal, then Congress should also weigh the impact on other issues, including safeguards for all USPS health plan fund assets by placing appropriate constraints on their asset allocations, such as limiting investments to Treasury securities and inflation-indexed Treasury securities or, if Congress chooses to permit investments in non-Treasury securities, constraints on the discount rate for prefunding purposes so as not to anticipate returns on risk-bearing assets in excess of those on Treasury securities before such returns have actually been achieved.

    Agency: Congress
    Status: Open

    Comments: As of May 2017, Congress had not enacted legislation that would create a U.S. Postal Service health plan that would result in an increase in retirees' use of Medicare. Therefore, Congress had not fully addressed the impact of safeguards for all USPS health plan fund assets by placing appropriate constraints on their asset allocations. In September 2015, S.2051: Improving Postal Operations, Service, and Transparency Act of 2015 was introduced to the to the U.S. Senate Committee on Homeland Security and Governmental Affairs. The bill requires all Medicare-eligible postal annuitants and employees enrolled in a U.S. Postal Service health plan to also enroll in Medicare, including parts A, B and D. This bill, however, has not yet been approved by the Senate Committee on Homeland Security and Governmental Affairs.
    Recommendation: A key matter for Congress to consider is whether or not to move forward with a USPS health plan that would result in an increase in retirees' use of Medicare. If Congress decides to approve this proposal, then Congress should also weigh the impact on other issues, including standards for the disposition of any surplus health plan assets that reduce the risk of a new unfunded liability emerging in the future, standards such as amortizing any surplus to mirror the amortization of any unfunded liability, or using any surplus to offset normal cost payments.

    Agency: Congress
    Status: Open

    Comments: As of May 2017, Congress had not enacted legislation that would create a U.S. Postal Service health plan that would result in an increase in retirees' use of Medicare. Consequently, Congress has not fully addressed the issue of standards for the disposition of any surplus health plan assets that reduce the risk of a new unfunded liability emerging in the future, such as amortizing any surplus to mirror the amortization of any unfunded liability, or using any surplus to offset normal cost payments.
    Recommendation: A key matter for Congress to consider is whether or not to move forward with a USPS health plan that would result in an increase in retirees' use of Medicare. If Congress decides to approve this proposal, then Congress should also weigh the impact on other issues, including designation or creation of an independent entity responsible for the selection of actuarial assumptions used to annually determine the funded status of USPS's health plan for purposes of determining prefunding payments.

    Agency: Congress
    Status: Open

    Comments: As of May 2017, Congress had not enacted legislation that would create a U.S. Postal Service health plan that would result in an increase in retirees' use of Medicare. Consequently, Congress has not fully addressed the designation or creation of an independent entity responsible for the selection of actuarial assumptions used to annually determine the funded status of USPS's health plan for purposes of determining prefunding payments.
    Recommendation: A key matter for Congress to consider is whether or not to move forward with a USPS health plan that would result in an increase in retirees' use of Medicare. If Congress decides to approve this proposal, then Congress should also weigh the impact on other issues, including protections for postal employees and retirees that are comparable to those under FEHBP, including a formula for USPS retirees' contribution to the costs of their health coverage.

    Agency: Congress
    Status: Open

    Comments: As of May 2017, Congress had not enacted legislation that would create a U.S. Postal Service health plan that would result in an increase in retirees' use of Medicare. Consequently, Congress has not fully addressed the issue of protections for postal employees and retirees that are comparable to those under FEHBP, including a formula for USPS retirees' contribution to the costs of their health coverage.
    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: 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: 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: Kohn, Linda T
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To ensure that nonmedical DOD research organizations coordinate with the Assistant Secretary of Defense for Health Affairs early in the research process to understand medical research requirements and avoid inefficiencies that may lead to duplicative work, the Secretary of Defense should direct the Under Secretary of Defense for Acquisition, Technology and Logistics to communicate to DOD's nonmedical research organizations the importance of coordination with the Joint Program Committee for Combat Casualty Care chair on combat casualty care issues, and require this coordination early in the research process when these organizations conduct research with implications for combat casualty care.

    Agency: Department of Defense
    Status: Open

    Comments: DOD took several actions in 2014 to communicate to DOD's nonmedical research organizations the importance of coordination with the Joint Program Committee for Combat Casualty Care. Specifically, DOD chartered the Armed Services Biomedical Research Evaluation and Management Community of Interest to include both medical and non-medical researchers and to improve coordination, collaboration, and cooperation. DOD also appointed senior leaders to work in both this community of interest and in other DOD research communities of interest, to improve coordination. Furthermore, DOD conducted joint research meetings to share research data across the medical and non-medical communities. As of September 2017, DOD had not indicated a requirement for this coordination to occur early in the research process, as included in GAO's 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: Goldstein, Mark L
    Phone: (202) 512-2834

    2 open recommendations
    Recommendation: The Chairman of the FCC should formally reassess the current RF energy exposure limit, including its effects on human health, the costs and benefits associated with keeping the current limit, and the opinions of relevant health and safety agencies, and change the limit if determined appropriate.

    Agency: Federal Communications Commission
    Status: Open

    Comments: The Federal Communications Commission (FCC) is developing a record on radiofrequency (RF) exposure limits with a Notice of Inquiry (in dockets 13-84 and 03-137). In the Inquiry, FCC requested comment to determine whether the RF exposure limits and policies need to be reassessed. FCC has not issued any further actions related to this inquiry, and does not have a schedule to resolve the issues in the open proceeding.
    Recommendation: The Chairman of the FCC should reassess whether mobile phone testing requirements result in the identification of maximum RF energy exposure in likely usage configurations, particularly when mobile phones are held against the body, and update testing requirements as appropriate.

    Agency: Federal Communications Commission
    Status: Open

    Comments: In 2013, FCC issued a Further Notice of Proposed Rulemaking in ET Docket No. 03-137, proposing to update and revise its mobile phone testing procedures. FCC staff is reviewing comments on the Further Notice of Proposed Rulemaking, and developing a rulemaking for consideration by the Commission. FCC does not yet have a timeline for further action in this rulemaking.
    Director: King, Kathleen M
    Phone: (202) 512-7114

    4 open recommendations
    Recommendation: In order to ensure an equitable allocation of CHS program funds, the Congress should consider requiring IHS to develop and use a new method to allocate all CHS program funds to account for variations across areas that would replace the existing base funding, annual adjustment, and program increase methodologies, notwithstanding any restrictions currently in federal law.

    Agency: Congress
    Status: Open

    Comments: As of January 2017, Congress has not acted on this recommendation. We will update the status of this recommendation if Congress takes action.
    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: 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: 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: Williamson, Randall B
    Phone: (206)287-4860

    5 open recommendations
    Recommendation: To address weaknesses in DCOE's strategic plan, the Secretary of Defense, through the Director of TMA, should direct the DCOE director to revisit and revise as necessary the organization's goals for completing statutorily required responsibilities.

    Agency: Department of Defense
    Status: Open

    Comments: As of July 2017, DOD 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 address weaknesses in DCOE's strategic plan, the Secretary of Defense, through the Director of TMA, should direct the DCOE director to require the directorates to align their day-to-day activities to support DCOE's mission and goals.

    Agency: Department of Defense
    Status: Open

    Comments: As of July 2017, DOD 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 address weaknesses in DCOE's strategic plan, the Secretary of Defense, through the Director of TMA, should direct the DCOE director to improve the performance measures in the plan to enable DCOE to determine if achievement of each measure fully supports attainment of its associated goal.

    Agency: Department of Defense
    Status: Open

    Comments: As of July 2017, DOD 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 ensure that DCOE obligations are properly classified and recorded in accordance with OMB guidance, the Secretary of Defense, through the Office of the Assistant Secretary of Defense (Health Affairs) (ASD(HA)), should direct TMA to develop written procedures with detailed steps to be performed for ensuring proper classification and recording of obligations in TMA's financial management systems.

    Agency: Department of Defense
    Status: Open

    Comments: As of July 2017, DOD 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 ensure that DCOE obligations are properly classified and recorded in accordance with OMB guidance, the Secretary of Defense, through the ASD(HA), should direct TMA to assign responsibility for updating and maintaining procedural guidance and systems codes to assure consistency with annual OMB guidance.

    Agency: Department of Defense
    Status: Open

    Comments: As of July 2017, DOD 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: 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.