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    Results:

    Topic: "Health Care"

    224 publications with a total of 606 open recommendations including 73 priority recommendations
    Director: Debra A. Draper
    Phone: (202) 512-7114

    5 open recommendations
    Recommendation: The Undersecretary for Health should develop and implement a process to accurately count all physicians providing care at each medical center, including physicians who are not employed by VHA. (Recommendation 1)

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Undersecretary for Health should develop and issue guidance to the VAMCs on determining appropriate staffing levels for all mission-critical physician occupations. (Recommendation 2)

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Undersecretary for Health should ensure that when multiple offices issue similar productivity data on physician occupations, any methodological differences are clearly communicated and guidance is provided on how to interpret and reconcile the data. (Recommendation 3)

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Undersecretary for Health should establish a system-wide method to share information about physician trainees to help fill vacancies across VAMCs. (Recommendation 4)

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Undersecretary for Health should conduct a comprehensive, system-wide evaluation of the physician recruitment and retention strategies used by VAMCs to determine their overall effectiveness, identify and implement improvements, ensure coordination across VHA offices, and establish an ongoing monitoring process. (Recommendation 5)

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

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

    2 open recommendations
    Recommendation: The Undersecretary for Health should take additional steps to ensure that VA's website reports health care quality measures that cover a broad range of health care services, highlights key differences in the clinical quality of care, and presents this information in an easily accessible and understandable way (Recommendation 1).

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Undersecretary for Health should direct VA Central Office to conduct a systematic assessment of the completeness and accuracy of patient clinical information across VAMCs that is used to calculate the health care quality measures VA reports and address any deficiencies that affect the accuracy of these measures (Recommendation 2).

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: 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

    6 open recommendations
    Recommendation: The Under Secretary for Health should further clarify when and for what purposes each national policy and guidance document type should be used, including whether guidance documents, such as program office memos, should be vetted and recertified. (Recommendation 1)

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Under Secretary for Health should develop standard processes for consistently maintaining and disseminating guidance documents to each level of the organization. (Recommendation 2)

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Under Secretary for Health should systematically obtain information on potential implementation challenges from VISNs and VAMCs and take the appropriate actions to address challenges prior to policy issuance. (Recommendation 3)

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Under Secretary for Health should establish a mechanism by which program offices systematically obtain feedback from VISNs and VAMCs on national policy after implementation and take the appropriate actions. (Recommendation 4)

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Under Secretary for Health should establish a standard policy exemption waiver process and centrally track and monitor approved waivers. (Recommendation 5)

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Under Secretary for Health should establish a standard process, including designated oversight roles, to periodically monitor that local policies established by VISNs and VAMCs align with national policies. (Recommendation 6)

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

    Comments: 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: John E. Dicken
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: In implementing the age and gender adjustment, the Commissioner of Internal Revenue should consider taking steps to mitigate the limitations of the BCBS Standard plan premium cost data--such as by combining data from multiple FEHBP plans. If combining the costs of plans with different benefit structures, the Commissioner should consider whether an appropriate actuarial adjustment should be used. If the Commissioner interprets that the statute does not provide the flexibility to mitigate the limitations of the BCBS Standard plan premium cost data by combining data from multiple sources or by other means, the Commissioner should seek that authority from Congress.

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

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

    4 open recommendations
    Recommendation: The Secretary of Veterans Affairs should direct the Acting Under Secretary for Health to develop and disseminate a system-wide standard operating procedure that clearly defines the roles and responsibilities of VAMCs in resolving pending enrollment applications.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Secretary of Veterans Affairs should direct the Acting Under Secretary for Health to clearly define oversight roles and responsibilities for HEC, and for Veterans Integrated Service Networks as appropriate, to help ensure timely processing of applications and accurate enrollment determinations.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Secretary of Veterans Affairs should direct the Acting Under Secretary for Health to develop procedures for collecting consistent and reliable data system-wide to track and evaluate timeliness of enrollment processes, and institute an oversight mechanism to ensure VAMC and HEC enrollment staff are appropriately following the procedures.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Secretary of Veterans Affairs should direct the Acting Under Secretary for Health to clarify its 5-day timeliness standard for processing enrollment applications, including whether it covers the total time needed to make an enrollment determination and the time applications are pending, and ensure the clarification is communicated system-wide.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    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: 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: Gerald L. Dillingham, Ph.D.
    Phone: (202) 512-2834

    4 open recommendations
    Recommendation: To increase transparency and obtain information to better inform decisions on whether to investigate potentially unfair or deceptive practices in the air ambulance industry, the Secretary of Transportation should communicate a method to receive air ambulance-related complaints, including those regarding balance billing, such as through a dedicated web page that contains instructions on how to submit air ambulance complaints and includes information on how DOT uses the complaints.

    Agency: Department of Transportation
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To increase transparency and obtain information to better inform decisions on whether to investigate potentially unfair or deceptive practices in the air ambulance industry, the Secretary of Transportation should take steps, once complaints are collected, to make pertinent aggregated complaint information publicly available for stakeholders, such as the number of complaints received by provider, on a monthly basis.

    Agency: Department of Transportation
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To increase transparency and obtain information to better inform decisions on whether to investigate potentially unfair or deceptive practices in the air ambulance industry, the Secretary of Transportation should assess available federal and industry data and determine what further information could assist in the evaluation of future complaints or concerns regarding unfair or deceptive practices.

    Agency: Department of Transportation
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To increase transparency and obtain information to better inform decisions on whether to investigate potentially unfair or deceptive practices in the air ambulance industry, the Secretary of Transportation should consider consumer disclosure requirements for air ambulance providers, which could include information such as established prices charged, business model and entity that establishes prices, and extent of contracting with insurance.

    Agency: Department of Transportation
    Status: Open

    Comments: 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

    15 open recommendations
    including 4 priority 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.
    Recommendation: To comply with improper payments reporting requirements and improve procedures related to processing PTC information on tax returns, the Commissioner of Internal Revenue should direct the appropriate officials to assess the program against applicable IPIA-defined thresholds and conclude on its susceptibility to significant improper payments, and revise the scope of its improper payments susceptibility assessment for the PTC program to include instances in which advance PTC is greater than or equal to the amount of PTC claimed on the tax return. If the program meets the IPIA definition for being susceptible to significant improper payments based on this assessment, estimate and report improper payments associated with the PTC program consistent with IPIA requirements.

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

    Comments: The IRS partially agreed with this recommendation. IRS stated that instances in which the advance payment of the PTC is greater than or equal to the amount of the PTC claimed on the tax return do not result in the IRS increasing the outlay related to PTC, and so by definition these occurrences are not subject to IPIA, as amended. The IRS understands and shares the concern about the misreporting of items on tax returns, including cases where the taxpayer misreports excess advance PTC, but the IRS has many compliance programs that operate outside the scope of IPIA and that address taxpayer error and noncompliance. The IRS conducted its fiscal year 2016 PTC improper payment risk assessment consistent with guidance from the Office of Management and Budget (OMB), which concurred with our methodology. However, the IRS is committed to discussing with OMB a future change to the agreed-upon procedures to assessing PTC improper payments as part of our larger and ongoing discussions with OMB about the administration of refundable tax credits and the challenges of reporting those credits through the framework of improper payments legislation and guidance.
    Recommendation: To comply with improper payments reporting requirements and improve procedures related to processing PTC information on tax returns, the Commissioner of Internal Revenue should direct the appropriate officials to assess and document the feasibility of approaches for incorporating information from the marketplaces on individuals who did not demonstrate that they met the eligibility requirements for citizenship or lawful presence in the tax compliance process. If determined feasible, IRS should work with Treasury to require marketplaces to periodically provide such information on individuals and use such information to recover advance PTC made for those individuals.

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

    Comments: The IRS agreed with this recommendation. IRS stated that it will evaluate the feasibility of receiving information from the marketplaces, and the value of using that information in its processes. If IRS determines that obtaining the data would be feasible and using it would be cost-effective, IRS will consult with Treasury on regulations or other guidance needed to obtain the information. Although eligibility determinations for the advance PTC are made outside the IRS's purview, the IRS has taken steps to ensure that the PTC is administered fairly and properly. For example, IRS has updated guidance in Publication 974, Premium Tax Credit, to clarify that any advance payment of the PTC made on behalf of individuals who did not meet the citizenship or lawful presence requirements must be repaid in full. Taxpayers are required to report the excess advance PTC on their tax returns. If they do not, IRS will address it through post-filing compliance. We will request and review supporting documentation for IRS's reported actions.
    Recommendation: To comply with improper payments reporting requirements and improve procedures related to processing PTC information on tax returns, the Commissioner of Internal Revenue should direct the appropriate officials to assess whether IRS should require its examiners to verify health care coverage of individuals to determine eligibility for PTC. To do this, IRS should complete its evaluation of the level of noncompliance related to duplicate health insurance coverage. Based on this evaluation and if cost effective, IRS should design and implement formal policies and procedures to routinely identify individuals inappropriately receiving PTC because of their eligibility for or enrollment in health care programs outside of the marketplaces and notify such individuals of their ineligibility for PTC.

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

    Comments: IRS agreed with this recommendation. IRS stated that it developed an Affordable Care Act (ACA) Compliance Strategy in October 2016, which included post-filing checks for the PTC. The IRS must rely upon post refund checks to verify if taxpayers had other healthcare coverage and therefore were not eligible to claim the PTC. For tax year 2017 the IRS plans to implement additional capabilities to evaluate coverage. The IRS will continue to evaluate the results and design and implement cost effective policies and procedures that routinely identify individuals inappropriately receiving PTC, as warranted.
    Recommendation: To comply with improper payments reporting requirements and improve procedures related to processing PTC information on tax returns, the Commissioner of Internal Revenue should direct the appropriate officials to design and implement procedures in the Internal Revenue Manual (IRM) for examiners in the post-filing compliance units to review tax returns for health insurance coverage for the entire year, and to identify and assess individual shared responsibility payments (SRP) from those who are not appropriately reporting SRPs on their tax returns.

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

    Comments: IRS disagreed with this recommendation. However, IRS stated that, among other things, it has drafted a new IRM section for examiners who are responsible for reviewing tax returns to determine whether health insurance is reflected for the taxpayer for the entire year, and for identifying and assessing SRP on taxpayers who are not appropriately reporting SRP on their tax returns. IRS stated that the IRM section is pending approval by Exam Policy. Although IRS stated that it disagreed with our recommendation, we believe that the actions that IRS described in its response to our draft report would sufficiently address our recommendation if implemented effectively.
    Recommendation: To comply with improper payments reporting requirements and improve procedures related to processing PTC information on tax returns, the Commissioner of Internal Revenue should direct the appropriate officials to design and implement procedures in the IRM to regularly notify nonfilers of the requirement to file tax returns in order to continue to receive advance PTC in the future.

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

    Comments: The IRS partially agreed with this recommendation. IRS stated that using a research-based approach to evaluate the 2015 tax filing season, it developed a post-compliance process for sending notices to individuals who received advance PTC paid on their behalf in the previous calendar year but failed to file a tax return and also to those who requested an extension to file. IRS stated that being flexible in its approach has allowed IRS to refine the process to improve efficiency and effectiveness. IRS further stated that based on the 2017 research analysis, IRS will determine whether the information should be included in an existing IRM. We agree that IRS should review its process to improve the efficiency and effectiveness of its operations. However, we continue to believe that designing and implementing procedures to regularly notify non-filers of the need to file to continue receiving advance PTC decreases the risk that the ad hoc notification process will not be followed consistently in each filing season.
    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: Gretta L. Goodwin
    Phone: (202) 512-8777

    5 open recommendations
    Recommendation: To better understand the available opportunities for collecting inmate health care utilization data, BOP should conduct a cost-effectiveness analysis of potential solutions, and take steps toward implementation of the most effective solution.

    Agency: Department of Justice: Bureau of Prisons
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To better understand the available opportunities for controlling health care costs, BOP should implement its guidance to conduct "spend analyses" of BOP's health care spending, using data sources already available

    Agency: Department of Justice: Bureau of Prisons
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To determine the actual or likely effectiveness of its ongoing or planned health care cost control initiatives, BOP should evaluate the extent to which its initiatives achieve their cost control aim.

    Agency: Department of Justice: Bureau of Prisons
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To enhance its strategic planning for and implementation of health care cost control efforts, BOP should incorporate elements of a sound planning approach and (1) establish a means of measuring progress toward and effectiveness of its activities for its current strategic objectives and goals related to controlling health care costs; and (2) identify the resources and investments necessary for implementation of its planned health care cost control initiatives.

    Agency: Department of Justice: Bureau of Prisons
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To improve the reliability and utility of its Federal Medical Center mission analyses, BOP should document the analyses and findings that underlie its recommendations.

    Agency: Department of Justice: Bureau of Prisons
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Melissa Emrey-Arras
    Phone: (617) 788-0534

    3 open recommendations
    Recommendation: To help ensure VHA medical examiners are prepared to conduct the Gulf War general medical exam, the Secretary of Veterans Affairs should direct the Under Secretary for Health to require medical examiners to complete training, such as the 90-minute Gulf War Illness web-based course, before conducting these exams.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VA agreed this recommendation and stated it has plans to address it. Specifically, VA said it plans to make its 90-minute web-based training course mandatory for its medical examiners who conduct Gulf War Illness exams.
    Recommendation: To provide more complete information to veterans whose Gulf War Illness claims are denied, the Secretary of Veterans Affairs should direct the Under Secretary for Benefits to update guidance to require that decision letters indicate whether Gulf War Illness medical issues were evaluated under both a presumptive and direct service connection method.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VA agreed this recommendation and stated it has plans in place to address it. Specifically, VA noted it would improve how it communicates decisions to veterans and is in the process of updating its guidance to the regional offices to clarify the language required for its Gulf War Illness decision letters.
    Recommendation: To increase the likelihood of making progress toward developing a single case definition of Gulf War Illness, the Secretary of Veterans Affairs should direct the Under Secretary for Health to prepare and document a plan to develop a single case definition of Gulf War Illness. This plan should include near- and long-term specific actions, such as analyzing and leveraging information in existing datasets and identifying any areas for future research to help VA achieve this goal.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VA agreed this recommendation and stated it has plans to address it. Specifically, VA noted it would convene a group of subject matter experts to work on a plan - as described in our report - to establish a single case definition of Gulf War Illness.
    Director: Valerie Melvin
    Phone: (202) 512-6304

    6 open recommendations
    Recommendation: To provide clinicians and pharmacists with improved tools to support pharmacy services to veterans and reduce risks to patient safety, the Secretary of Veterans Affairs should direct the Assistant Secretary for Information and Technology and the Under Secretary for Health to establish and implement a plan for updating the pharmacy system to address the inefficiencies with viewing patient medication data in the Outpatient Pharmacy application and between the pharmacy application and viewers.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VA concurred with our recommendation and in August 2017 stated that it had identified $4 million in fiscal year 2018 to establish a pharmacy graphical user interface. According to the department, it plans to complete its action in response to this recommendation by June 2018.
    Recommendation: To provide clinicians and pharmacists with improved tools to support pharmacy services to veterans and reduce risks to patient safety, the Secretary of Veterans Affairs should direct the Assistant Secretary for Information and Technology and the Under Secretary for Health to complete a plan for the implementation of an approach to data standardization that will support the capability for clinicians and pharmacists to view complete DOD data and receive order checks that consistently include DOD data.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VA concurred in principle with our recommendation and in August 2017 stated that it plans to implement the electronic health record system that is being deployed by DOD, which will present VA clinicians with complete DOD data and the ability to perform order checks on DOD data. In parallel, the department is continuing and expanding the implementation of data standardization. According to the department, it plans to complete its action in response to this recommendation by October 2019.
    Recommendation: To provide clinicians and pharmacists with improved tools to support pharmacy services to veterans and reduce risks to patient safety, the Secretary of Veterans Affairs should direct the Assistant Secretary for Information and Technology and the Under Secretary for Health to conduct an assessment to determine to what extent interoperability of VA's pharmacy system with DOD's pharmacy system is impacting transitioning service members.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VA concurred with our recommendation and in May 2017 stated that the health executive committee would complete an assessment to determine the extent interoperability with DOD's pharmacy system is impacting transitioning service members. According to the department, it planned to complete its actions in response to this recommendation by September 2017. We will update the status of this recommendation when VA provides documentation of its interoperability assessment to us.
    Recommendation: To provide clinicians and pharmacists with improved tools to support pharmacy services to veterans and reduce risks to patient safety, the Secretary of Veterans Affairs should direct the Assistant Secretary for Information and Technology and the Under Secretary for Health to develop and execute a plan for implementing the capability to send outbound e-prescriptions to non-VA pharmacies, in accordance with National Council for Prescription Drug Programs standards.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VA concurred with our recommendation and in August 2017 stated that it will review its plan for e-prescribing functionality after it has signed a contract to adopt the electronic health record system that is being deployed by DOD. According to the department, it plans to complete its action in response to this recommendation by March 2018.
    Recommendation: To provide clinicians and pharmacists with improved tools to support pharmacy services to veterans and reduce risks to patient safety, the Secretary of Veterans Affairs should direct the Assistant Secretary for Information and Technology and the Under Secretary for Health to ensure that the department's evaluation of alternatives for electronic health records includes consideration for additional generation level 3 capability such as navigating from an alert to medication order in the electronic health record system.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VA concurred with our recommendation and in August 2017 stated that it had entered into contract negotiations to acquire and deploy a level 3 electronic health record system that is expected to address pharmacy functions. The department plans to award this contract in December 2017. We will update the status of this recommendation when VA provides documentation of its evaluation of alternatives to us.
    Recommendation: To provide clinicians and pharmacists with improved tools to support pharmacy services to veterans and reduce risks to patient safety, the Secretary of Veterans Affairs should direct the Assistant Secretary for Information and Technology and the Under Secretary for Health to reassess the priority for establishing an inventory management capability to monitor and update medication levels and track when to reorder medications.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VA concurred with our recommendation and in August 2017 stated that it will reassess the prioritization of medication inventory management after a contract for adoption of the electronic health record system is signed in December 2017. According to the department, it plans to complete its action in response to this recommendation by June 2018.
    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: Randall B. Williamson
    Phone: (202) 512-7114

    4 open recommendations
    Recommendation: To improve the completeness and accuracy of VA's productivity metrics and efficiency models and strengthen the monitoring of clinical productivity and efficiency VA-wide, the Secretary of the Department of Veterans Affairs should direct the Undersecretary for Health to expand existing productivity metrics to track the productivity of all providers of care to veterans by, for example, including contract physicians who are not VA employees as well as advance practice providers acting as sole providers.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To improve the completeness and accuracy of VA's productivity metrics and efficiency models and strengthen the monitoring of clinical productivity and efficiency VA-wide, the Secretary of the Department of Veterans Affairs should direct the Undersecretary for Health to help ensure the accuracy of underlying staffing and workload data by, for example, developing training to all providers on coding clinical procedures.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To improve the completeness and accuracy of VA's productivity metrics and efficiency models and strengthen the monitoring of clinical productivity and efficiency VA-wide, the Secretary of the Department of Veterans Affairs should direct the Undersecretary for Health to develop a policy requiring VAMCs to monitor and improve clinical efficiency through a standard process, such as establishing performance standards based on VA's efficiency models and developing a remediation plan for addressing clinical inefficiency.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To improve the completeness and accuracy of VA's productivity metrics and efficiency models and strengthen the monitoring of clinical productivity and efficiency VA-wide, the Secretary of the Department of Veterans Affairs should direct the Undersecretary for Health to establish an ongoing process to systematically review VAMCs' remediation plans and ensure that VAMCs and Veterans Integrated Service Networks are successfully implementing remediation plans for addressing low clinical productivity and inefficiency.

    Agency: Department of Veterans Affairs
    Status: Open

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

    5 open recommendations
    Recommendation: To increase its assurance that PTSD and TBI are appropriately considered prior to separating certain servicemembers from the military for misconduct, the Secretary of Defense should direct the Air Force and Navy to address inconsistencies with DOD policy in their policies related to screening certain servicemembers, including servicemembers separating in lieu of trial by court-martial, for PTSD and TBI and reviewing the results prior to separation for misconduct.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To increase its assurance that PTSD and TBI are appropriately considered prior to separating certain servicemembers from the military for misconduct, the Secretary of Defense should direct the Air Force and Navy to address inconsistencies with DOD policy in their policies related to training servicemembers, including officers, on how to identify mild TBI symptoms in the deployed setting.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To increase its assurance that PTSD and TBI are appropriately considered prior to separating certain servicemembers from the military for misconduct, the Secretary of Defense should ensure that the military services routinely monitor adherence to policies related to screening certain servicemembers for PTSD and TBI prior to separation for misconduct.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To increase its assurance that PTSD and TBI are appropriately considered prior to separating certain servicemembers from the military for misconduct, the Secretary of Defense should ensure that the military services routinely monitor adherence to policies related to training servicemembers, including officers, on how to identify mild TBI symptoms in the deployed setting.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To increase its assurance that PTSD and TBI are appropriately considered prior to separating certain servicemembers from the military for misconduct, the Secretary of Defense should ensure that the military services routinely monitor adherence to policies related to counseling about VA benefits and services during the process of separating certain servicemembers for misconduct.

    Agency: Department of Defense
    Status: Open

    Comments: 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

    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: 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: Randall B. Williamson
    Phone: (202) 512-7114

    6 open recommendations
    Recommendation: To help VHA achieve its objective of reducing the risk of diversion through effective implementation and oversight of the controlled substance inspection program, the Secretary of Veterans Affairs should direct the Under Secretary for Health to ensure that VA medical facilities have established an additional control procedure, such as an alternate controlled substance coordinator or additional inspectors, to help coordinators meet their responsibilities and prevent missed inspections.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To help VHA achieve its objective of reducing the risk of diversion through effective implementation and oversight of the controlled substance inspection program, the Secretary of Veterans Affairs should direct the Under Secretary for Health to ensure that VA medical facilities have established a process where coordinators, in conjunction with appropriate stakeholders (e.g., pharmacy officials), periodically compare facility inspection procedures to VHA's policy requirements and modify facility inspection procedures as appropriate.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To help VHA achieve its objective of reducing the risk of diversion through effective implementation and oversight of the controlled substance inspection program, the Secretary of Veterans Affairs should direct the Under Secretary for Health to improve the training of VA medical facility controlled substance coordinators by ensuring the training includes the inspection procedures that VHA requires.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To help VHA achieve its objective of reducing the risk of diversion through effective implementation and oversight of the controlled substance inspection program, the Secretary of Veterans Affairs should direct the Under Secretary for Health to ensure that medical facility directors have designed and implemented a process to address nonadherence with program requirements, including documenting the nonadherence and the corrective actions taken to remediate nonadherence or the actions that demonstrate why no remediation is necessary.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To help VHA achieve its objective of reducing the risk of diversion through effective implementation and oversight of the controlled substance inspection program, the Secretary of Veterans Affairs should direct the Under Secretary for Health to ensure that networks review their facilities' quarterly trend reports and ensure facilities take corrective actions when nonadherence is identified.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To help VHA achieve its objective of reducing the risk of diversion through effective implementation and oversight of the controlled substance inspection program, the Secretary of Veterans Affairs should direct the Under Secretary for Health to ensure that networks monitor their medical facilities' efforts to establish and implement a review process to periodically compare facility inspection procedures to VHA's policy requirements.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Joe Kirschbaum
    Phone: (202) 512-9971

    3 open recommendations
    Recommendation: As DOD plans to respond to a pandemic, the Secretary of Defense should direct the Under Secretary of Defense for Policy and other DOD officials, as appropriate, to use DOD's existing coordination mechanisms with HHS and the Federal Emergency Management Agency (FEMA) to explore opportunities to improve their preparedness and response to a pandemic if DOD's capabilities are limited.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: 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.
    Recommendation: As DHS, through FEMA, plans to respond to a pandemic, the Secretary of Homeland Security should direct the Administrator of FEMA to use FEMA's existing coordination mechanisms with DOD and HHS to explore opportunities to improve their preparedness and response to a pandemic if DOD's capabilities are limited.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    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: Brenda S. Farrell
    Phone: (202) 512-3604

    8 open recommendations
    Recommendation: The Secretary of Defense should direct the Under Secretary of Defense for Personnel and Readiness to incorporate medical screening questions specific to gambling disorder as part of a systematic screening process across DOD, such as DOD's annual Periodic Health Assessment, for behavioral and mental-health issues.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Secretary of Defense should direct the Under Secretary of Defense for Personnel and Readiness to update DOD Instruction 1010.04, Problematic Substance Use by DOD Personnel, to explicitly include gambling disorder as defined in the 2013 Diagnostic and Statistical Manual of Mental Disorders.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Secretary of Defense should direct the Secretary of the Army to update Army Regulation 600-85, The Army Substance Abuse Program, to explicitly include gambling disorder.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Secretary of Defense should direct the Secretary of the Navy to update Naval Operations Instruction 5350.4D, Navy Alcohol and Drug Abuse Prevention and Control, to explicitly include gambling disorder.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Secretary of Defense should direct the Secretary of the Air Force to update Air Force Instruction 44-121, Alcohol and Drug Abuse Prevention and Treatment (ADAPT) Program, to explicitly include gambling disorder.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Secretary of Defense should direct the Commandant of the Marine Corps to update Marine Corps Order 5300.17, Marine Corps Substance Abuse Program, to explicitly include gambling disorder.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Commandant of the Coast Guard should update Commandant Instruction M6000.1F, Coast Guard Medical Manual, to classify gambling disorder as an addiction and not as an impulse control issue.

    Agency: Department of Homeland Security: United States Coast Guard
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Commandant of the Coast Guard should update Commandant Instruction M1000.10, Coast Guard Drug and Alcohol Abuse Program, to explicitly include gambling disorder.

    Agency: Department of Homeland Security: United States Coast Guard
    Status: Open

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

    4 open recommendations
    Recommendation: The Secretaries of Veterans Affairs and Defense should collaborate to develop time frames and interim milestones for tracking and implementing each of their jointly developed recommended improvements.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Secretaries of Veterans Affairs and Defense should collaborate to develop time frames and interim milestones for tracking and implementing each of their jointly developed recommended improvements.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Secretaries of Veterans Affairs and Defense should collaborate to conduct a cost-effectiveness analysis for the FHCC to establish a baseline for measuring the facility's efficiency over time.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Secretaries of Veterans Affairs and Defense should collaborate to conduct a cost-effectiveness analysis for the FHCC to establish a baseline for measuring the facility's efficiency over time.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    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: Robert Goldenkoff
    Phone: (202) 512-2757

    12 open recommendations
    including 5 priority recommendations
    Recommendation: To improve the capacity of HR functions at VA medical centers, the Secretary of Veterans Affairs should instruct the Under Secretary for Health to assign the following responsibility to the Assistant Deputy Under Secretary for Health for Workforce Service: develop a comprehensive competency assessment tool for HR staff that evaluates knowledge of all three personnel systems, (Title 5, Title 38 and Title 38-Hybrid).

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: We will provide updated information once we confirm what actions the agency has taken in response to this recommendation.
    Recommendation: To improve the capacity of HR functions at VA medical centers, the Secretary of Veterans Affairs should instruct the Under Secretary for Health to assign the following responsibility to the Assistant Deputy Under Secretary for Health for Workforce Service: ensure that all VHA HR staff complete the competency assessment tool and use this data to identify and address competency gaps within HR offices.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To improve the capacity of HR functions at VA medical centers, the Secretary of Veterans Affairs should instruct the Under Secretary for Health to assign the following responsibility to the Assistant Deputy Under Secretary for Health for Workforce Service: evaluate the extent to which training strategies are effective for improving the skills and competencies of HR staff.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: We will provide updated information once we confirm what actions the agency has taken in response to this recommendation.
    Recommendation: To improve the capacity of HR functions at VA medical centers, the Secretary of Veterans Affairs should instruct the Under Secretary for Health to establish clear lines of authority that provide the Assistant Deputy Under Secretary for Health for Workforce Service the ability to oversee and hold medical center HR offices accountable for implementing initiatives to improve HR processes within HR offices as well as monitoring and reporting on the results of these initiatives.

    Agency: Department of Veterans Affairs
    Status: Open
    Priority recommendation

    Comments: VA agreed with our recommendation and stated that it plans to address this recommendation through an organizational realignment. As a first step, in March 2017, the Acting Under Secretary for Health issued a memo to VHA Deputy Under Secretaries, Network Directors, and Medical Center Directors stating that these officials are accountable for ensuring efficient and effective human capital service delivery. To fully implement the recommendation to hold medical center HR offices accountable, VA needs to establish procedures for monitoring and reporting on the results of its HR improvement initiatives.
    Recommendation: To improve the capacity of HR functions at VA medical centers, the Secretary of Veterans Affairs should instruct the Under Secretary for Health to establish clear lines of authority that provide the Assistant Deputy Under Secretary for Health for Workforce Service the ability to oversee and hold medical center HR offices accountable for requiring all HR staff to complete the competency assessment tool within HR offices.

    Agency: Department of Veterans Affairs
    Status: Open
    Priority recommendation

    Comments: VA agreed with our recommendation and stated that it was taking steps to address it. As a first step, in March 2017, the Acting Under Secretary for Health issued a memo stating that the Assistant Deputy Under Secretary for Health for Workforce Services (ADUSHWFS) is authorized to establish HR competencies for VHA HR staff, and also require VHA HR staff to complete HR competency assessments and training. Further, the memo requires the ADUSHWFS to report quarterly to the DUSHOM on the status of HR competency assessments and training completion. In late April 2017, VA officials stated that they are establishing processes to collect and monitor data on completion rates for the HR staff competency assessment tool. To fully implement the recommendation, VA should implement these processes and provide quarterly data on competency tool completion rates to the DUSHOM.
    Recommendation: To ensure VA medical centers make needed improvements to HR functions, such as those identified by VA's Office of Oversight and Effectiveness and VHA's Consult, Assist, Review, Develop, and Sustain (CARDS) reviews, the Secretary of Veterans Affairs should provide the Assistant Secretary for Human Resources and Administration (HR&A) and the Under Secretary for Health with the oversight responsibility of effectively monitoring the status of corrective actions at medical center HR offices and ensuring that corrective actions are implemented.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: We will provide updated information once we confirm what actions the agency has taken in response to this recommendation.
    Recommendation: To ensure that positions across all VHA medical facilities are placed in the appropriate class and grade, the Secretary of Veterans Affairs should direct the Assistant Secretary for HR&A and the Under Secretary for Health to clarify their lines of authority and processes for overseeing and holding Veterans Integrated Service Network (VISNs) and VHA medical facilities accountable for the consistent application of federal classification policies.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: We will provide updated information once we confirm what actions the agency has taken in response to this recommendation.
    Recommendation: To accelerate efforts to develop a modern, credible, and effective performance management system the Assistant Secretary for HR&A should, with input from VHA stakeholders, ensure that meaningful distinctions are being made in employee performance ratings by (1) developing and implementing a standardized, comprehensive performance management training program for supervisors of Title 5, Title 38, and Title 38-Hybrid employees based on leading practices and ensuring procedures are in place to support effective performance conversations between supervisors and employees; (2) reviewing and revising Title 5 and Title 38 performance management policies consistent with leading practices (e.g., require definition of all performance levels); and (3) developing and implementing a process to standardize performance plan elements, standards, and metrics for common positions across VHA that are covered under VA's Title 5 performance management system.

    Agency: Department of Veterans Affairs: Assistant Secretary for Human Resources and Administration
    Status: Open
    Priority recommendation

    Comments: VA partially agreed with our recommendation and described the preliminary steps it is planning to take to identify and implement a modern, credible, and effective performance management system. In late April 2017, VA officials stated that they are in the early stages of identifying a way forward for a revised performance management system, and are considering different options. To implement our recommendation, VA must ensure that meaningful distinctions are being made in employee performance ratings. This includes reviewing and revising Title 5 and Title 38 performance management policies consistent with leading practices (e.g., requiring definition of all performance levels), and developing and implementing a process to standardize performance plan elements, standards, and metrics for all common Title 5 positions across VHA. We recognize that identifying and implementing a new performance management system will require significant effort on VA's part, and will continue to monitor its actions and progress in this area.
    Recommendation: To accelerate efforts to develop a modern, credible, and effective performance management system, the Assistant Secretary for HR&A should, with input from VHA stakeholders, ensure that ratings-based performance awards are administered in a manner that is consistent with leading practices and promotes improved employee performance.

    Agency: Department of Veterans Affairs: Assistant Secretary for Human Resources and Administration
    Status: Open
    Priority recommendation

    Comments: VA partially agreed with our recommendation and stated that it will explore how to create effective incentive and reward systems. VA also noted that due to constrained funding for such systems, it will pursue ways to maximize effective use of both monetary and non-monetary awards to promote employee performance. In late April 2017, VA officials stated that they are in the early stages of identifying a way forward for a revised performance management system (including ratings-based awards), and are considering different options. To implement our recommendation, VA must ensure that its award programs are administered in a valid, reliable, and transparent manner. We recognize that identifying and implementing a new performance management system will require significant effort on VA?s part, and will continue to monitor its actions and progress in this area.
    Recommendation: To accelerate efforts to develop a modern, credible, and effective performance management system, the Assistant Secretary for HR&A should, with input from VHA stakeholders, develop a plan for how and when it intends to implement a modern information technology (IT) system to support employee performance management processes.

    Agency: Department of Veterans Affairs: Assistant Secretary for Human Resources and Administration
    Status: Open
    Priority recommendation

    Comments: VA partially agreed with this recommendation and stated that it continues to pilot its performance appraisal IT system -- known as the ePerformance system -- but that broad implementation of new technology for performance management will require adequate IT funding. In late April 2017, VA officials stated that they are exploring other potential IT systems to support the performance management process. To implement our recommendation, VA must develop a plan for how and when it intends to implement a modern performance management IT system.
    Recommendation: To better monitor and improve employee engagement, the Under Secretary for Health should establish clear and effective lines of authority and accountability for developing, implementing, and monitoring strategies for improving employee engagement across VHA, such as by establishing an employee engagement office at the VHA headquarters level with appropriate oversight of VISNs and medical center initiatives.

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

    Comments: We will provide updated information once we confirm what actions the agency has taken in response to this recommendation.
    Recommendation: To better monitor and improve employee engagement, the Under Secretary for Health should ensure that VHA and VISN entities jointly develop (1) a system to facilitate sharing of employee engagement leading practices/lessons learned; and (2) a strategy to help address barriers to improving engagement, particularly for those medical centers with the lowest engagement scores.

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

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

    1 open recommendations
    Recommendation: The Executive Director of NCD should assign responsibilities for conducting future campaign activities and develop an evaluation plan for its activities.

    Agency: National Council on Disability
    Status: Open

    Comments: As of July 2017, the National Council on Disability (NCD) had developed a plan for conducting campaign activities that had assigned responsibilities. However, as a result of recent changes in leadership and staff, several key activities do not have staff assigned and will need to be updated to ensure responsibility for completing the plan. Additionally, NCD said that they plan to conduct an internal audit in December 2017 to monitor the progress of their activities. While this audit is helpful in identifying progress to date, our recommendation suggests that NCD should also plan to evaluate the effectiveness of its activities.
    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: Randall B. Williamson
    Phone: (202) 512-7114

    2 open recommendations
    including 1 priority recommendation
    Recommendation: To improve care for women veterans, the Secretary of Veterans Affairs should direct the Under Secretary for Health to strengthen the environment of care inspections process and VHA's oversight of this process by expanding the list of requirements that facility staff inspect for compliance to align with VHA's women's health handbook, ensuring that all patient care areas of the medical facility are inspected as required, clarifying the roles and responsibilities of VA medical facility staff responsible for identifying and addressing compliance, and establishing a process to verify that noncompliance information reported by facilities to VHA Central Office is accurate and complete.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: As of June 2017, VA has taken some actions to address this recommendation, but additional actions are needed to fully implement it. We will update the status of this recommendation when we receive additional information from VA.
    Recommendation: To improve care for women veterans, the Secretary of Veterans Affairs should direct the Under Secretary for Health to monitor women veterans' access to key sex-specific care services--mammography, maternity care, and gynecology--under current and future community care contracts. For those key services, monitoring should include an examination of appointment scheduling and completion times, driving times to appointments, and reasons appointments could not be scheduled with community providers.

    Agency: Department of Veterans Affairs
    Status: Open
    Priority recommendation

    Comments: As of June 2017, VHA still lacks data and performance measures for the availability under Choice of sex-specific care, such as mammograms, maternity care, or gynecology. In contrast, for another VA care in the community program, PC3 (a program that the Choice third party administrators also administer) VHA collects data and has performance measures to evaluate women veterans' access to mammography and maternity care. To fully implement this recommendation, VHA needs to extend the collection of data to include care delivered through the Choice Program and other community care programs and establish related performance measures.
    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: David B. Gootnick
    Phone: (202) 512-3149

    4 open recommendations
    Recommendation: To ensure that USAID reimburses funds in accordance with section 9002 of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2015, the Administrator of USAID should reverse reimbursements that were not made to the same appropriation account as the account from which USAID obligated the funds.

    Agency: United States Agency for International Development
    Status: Open

    Comments: USAID concurred with the recommendation. In written comments on a draft of this report, USAID noted that it is examining whether sufficient appropriate resources exist to support all of the obligations against the accounts that were improperly reimbursed. As of September 2017, USAID is in the process of reversing the improper reimbursements. We will continue to monitor USAID's efforts to implement our recommendation.
    Recommendation: To ensure that USAID reimburses funds in accordance with section 9002 of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2015, the Administrator of USAID should reverse reimbursements for which there is no documentary evidence that the obligation was incurred to prevent, prepare for, and respond to the Ebola outbreak.

    Agency: United States Agency for International Development
    Status: Open

    Comments: USAID concurred with the recommendation. In written comments on a draft of this report, USAID stated that it would reverse reimbursements for which the documentation was lacking that the obligation was incurred to prevent, prepare for, and respond to the Ebola outbreak. As of September 2017, USAID is in the process of reversing the reimbursements. We will continue to monitor USAID's efforts to implement our recommendation.
    Recommendation: To ensure that USAID reimburses funds in accordance with section 9002 of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2015, the Administrator of USAID should determine whether reversing any of these reimbursements results in the obligation of funds in excess of appropriations in violation of the Antideficiency Act and, if so, report any violations in accordance with law.

    Agency: United States Agency for International Development
    Status: Open

    Comments: USAID concurred with the recommendation. In written comments on a draft of this report, USAID noted that USAID's Office of the Chief Financial Officer has been notified of a potential funds control violation and that USAID's ongoing review will determine whether an Antideficiency Act violation occurred. USAID further noted that, in the event it finds an Antideficiency Act violation, the agency would notify the violation in accordance with the law. In September 2017, USAID told GAO that it is finalizing the determination regarding the potential Antideficiency Act violation. We will continue to monitor USAID's efforts to implement our recommendation.
    Recommendation: To help ensure that USAID complies with reimbursement provisions that may arise in future appropriations laws, the Administrator of USAID should develop written policies and procedures for the agency's reimbursement process.

    Agency: United States Agency for International Development
    Status: Open

    Comments: USAID concurred with the recommendation. In written comments on a draft of this report, USAID noted that the agency will develop written policies and procedures that adequately address reimbursement provisions of applicable appropriations laws. In September 2017, USAID told GAO that it is in the process of finalizing the written policies and procedures for the agency's reimbursement process. We will continue to monitor USAID's efforts to implement our recommendation.
    Director: Debra A. Draper
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: The Secretary of Veterans Affairs should direct the Under Secretary for Health to define the roles and responsibilities of VAMCs in operationalizing VHA's strategic goals and objectives; this could be accomplished by establishing roles and responsibilities for VAMCs similar to how VHA defines roles and responsibilities for VISNs in VHA Directive 1075 and by developing guidance for VAMCs similar to guidance developed for VISNs.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: According to officials, VHA's Office of Policy and Planning continues to routinely communicate that all components of the organization should align their activities and resources to VA's 2014-2020 strategic goals and objectives, the MyVA Priority and Management Initiatives, and to the five VHA Priorities for Strategic Action. VHA's Office of Policy and Planning has also developed and disseminated Strategic Principals for Operational and Programmatic Decision Making, which was intended to provide a set of unifying principles for operational and programmatic decision-making. In its September 2017 update, VHA provided GAO with a copy of its draft FY 2018-2019 Operational and Modernization Plan. VHA is also in process of developing an Operational Planning Worksheet that is intended to provide instructions, definitions and examples to help create meaningful tactics, identify accountable leads, and document relevant interdependencies and requirements across the organization for VAMCs, VISNs and Program Offices. In its September 2017 update, VHA also noted that the National Leadership Council Strategic Planning Summit was held in June 2017, and that the focus of the summit was to ensure a clear understanding of the five VA/VHA priorities and how to operationalize the priorities at all levels of the organization. According to officials, VHA also held its National Planning Training (NPT) in August 2017 and the training was designed around the five VA/VHA priorities with a significant emphasis on clarifying the roles and responsibilities of VA Health Care Systems, VISNs and Program Offices in operationalizing the five priorities. According to officials, presentations incorporated the five priorities and a discussion on the various operational roles across the organization. VHA also noted that an online discussion board was opened at the conclusion of each NPT session with discussion questions specific to clarifying implementation responsibilities for the five VA/VHA priorities and other strategic initiatives. GAO has requested that VHA provide documentary evidence of these activities to support closure of this recommendation.
    Recommendation: The Secretary of Veterans Affairs should direct the Under Secretary for Health to consistently develop strategies that can be used by VISNs and VAMCs to operationalize VHA's goals and objectives, ensuring that they clearly link directly to VHA's goals and objectives.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: According to officials, VHA held its annual National Leadership Council Strategic Planning Summit in June 2017, during which NLC members and other strategic thinkers representing Program Office and VA Health Care Systems identified a set of strategies and milestones that link to and support operationalizing the five VA/VHA priorities. According to officials, these 16 strategies and milestones serve as the initial framework for operational planning at the VA Health Care System, VISN, and Program Office levels. VHA has provided evidence that it is currently developing its 2018 modernization and operational planning guidance, which is expected to link VA's strategic goals and objectives to the modernization plan and the five VA/VHA priorities. The guidance is also expected to require program offices, VISNs, and VAMCs to submit plans that articulate tactics and milestones and identify requirements that clearly link organizational activities back to operationalizing strategies and accomplishing priorities and goals. According to officials, the next phase of operational planning will occur at the VA Senior Leaders' Business Meeting, during which VA Health Care System, VISN, and Program Office leaders will further detail plans by identifying the tactics and requirements each will implement to operationalize the strategies and achieve the priorities, including identifying individuals that will be responsible for leading implementation of tactics. According to officials, VHA will initiate the final phase of operational planning following this meeting. During this final phase, VHA expects to disseminate its operational plan, and guidance, to VISNs and Program Offices with guidance to work with their subcomponents (VAMCs and other divisions) to finalize details in support of the operational plan. Following, the VISNs and Program Offices are expected to return their plans to VHA's Office of Policy and Planning to be incorporated into VHA's final modernization and operational plan. According to officials, VHA's Office of Policy and Planning has also continued to work very closely with the VA Office of Enterprise Integration to link VHA's strategies and measures with VA's draft 2018-2024 goals, objectives, strategies and measures to ensure consistency and alignment in planning and operationalization. According to officials, these linkages will enable VHA and VA to monitor and report progress on achieving the five VA/VHA priorities.
    Recommendation: The Secretary of Veterans Affairs should direct the Under Secretary for Health to develop an oversight process to assess progress made in meeting VHA's strategic goals and objectives, including feedback on how well activities and programs are contributing to achieving these goals and objectives.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: In its 60-day update, VHA notified GAO that performance plans for senior executives will be updated to include requirements to provide oversight to assure that day-to-day activities on initiatives and programs are consistent with organizational goals, objectives and priorities. Furthermore, VHA informed GAO that executive performance, and performance of the organizations they lead, will be assessed using periodic review of performance against established organizational metrics associated with priorities, and annual performance plans of senior executives. In its 60 day update, VHA also notified GAO that VHA's Office of Policy and Planning will monitor implementation on a periodic basis to identify when initiatives or programs are progressing appropriately or at risk of not achieving goals and objectives in accordance with priorities. In VHA's August 2017 update on open recommendations, officials noted that VHA has also developed an internal Healthcare Operations Dashboard--which provides immediate and daily information regarding veterans' health care access, including wait times, productivity, and utilization--and an externally-facing Access and Quality in VA Healthcare web site--which provides veterans, caregivers, and other stakeholders with tools to view access and quality performance for specific VA facilities. According to VHA officials, both VA and VHA are monitoring strategic programs and activities to identify barriers that may impede progress towards the achievement of goals and objectives, which can then be elevated to leadership, as appropriate. In VHA's September 2017 update, officials also noted that VHA's Office of Policy and Planning and Office of Strategic Integration are coordinating the monitoring and quarterly reporting of progress on achievements related to the five VA/VHA priorities and the supporting strategies. According to officials, Priority and Strategy leads have been identified and are responsible for reporting operational progress and for managing any challenges that slow or prevent operationalization. According to officials, progress on all strategies and priorities is being reported at the VHA senior leaders morning meeting on a routine basis. GAO has requested that VHA provide documentary evidence of these activities to support closure of this recommendation.
    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: Debra Draper
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: The Secretary of Veterans Affairs should direct the Under Secretary for Health to conduct an evaluation of the implementation of the VISN realignment to determine whether deficiencies exist that need corrective actions, and apply lessons learned from the evaluation to future organizational structure changes, such as possible changes to VISN staffing models or actions to implement Commission on Care recommendations.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VHA concurred with this recommendation, stating that VHA's Office of Workforce Management and Consulting (WMC) would evaluate the implementation of the VISN realignment to include the identification of deficiencies for correction, lessons learned, and potential changes to the VISN staffing models. VHA stated that as the implementation activities near completion in fiscal year 2017, WMC would evaluate the effectiveness and efficiency of the VISN realignment processes. In December 2016, VHA reported that WMC had begun consultations with the Office of Strategic Integration on a strategic assessment of the VHA organizational structure in the field to 1) identify and recommend to leadership optimal proposals for organization design efficiencies and 2) define and recommend analytical and implementation procedures that will avoid the challenges from previous field reorganizations. As of April 2017, VHA reported that the Principal Deputy Under Secretary for Health found that lessons learned from the VISN Realignment Workgroup needed to be incorporated into the VA Modernization initiative, and directed the VHA's Office of Strategic Integration to coordinate with WMC and former members of the VISN Realignment Workgroup to determine how best to document lessons learned and apply them to future organizational structure changes. In July 2017, VHA told us that a Rapid Design and Implementation functional assessment of VHA Central Office and VISN organizations had been completed, which included a survey, interviews with central office and VISN officials, and other meetings. VHA stated its target completion date of September 2017 was unchanged, but did not provide additional detail on how the functional assessment is related to the evaluation of the VISN realignment that we recommended VHA conduct, or how lessons learned from the realignment are being incorporated into organizational structure changes such as the new functional chart VHA reported developing.
    Recommendation: The Secretary of Veterans Affairs should direct the Under Secretary for Health to develop a process to ensure that organizational structure recommendations resulting from internal and external reviews of VHA are evaluated for implementation. This process should include the documentation of decisions and assigning officials or offices responsibility for ensuring that approved recommendations are implemented.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VHA concurred with this recommendation. In December 2016, VHA stated that its Office of Workforce Management and Consulting (WMC) had begun to develop a consistent process to ensure that organizational structure changes are evaluated and implemented appropriately. In addition, a first draft of a permanent organization approval procedure had been completed and was undergoing review for the Under Secretary for Health. In May 2017, VHA officials told us their initial work on this recommendation was paused to allow the Agency to respond to President Trump's Executive Order dated March 13, 2017, on "Comprehensive Plan for Reorganizing the Executive Branch." VHA reported that WMC's proposed process will be assessed in the context of the Executive Order. In July 2017, VHA reported that the VA Modernization Team evaluated the results from a VHA Rapid Design and Implementation functional review, which was conducted to determine where shared areas of responsibilities and redundancies exist across VHA, and developed a draft functional chart that was under review. WMC anticipated continuing work on this recommendation after the functional chart's approval, with an anticipated completion date of September 2017. We will follow-up with VHA to obtain updates on both the organizational structure changes process as well as the new functional chart for VHA.
    Director: Farrell, Brenda S
    Phone: (202) 512-3604

    6 open recommendations
    Recommendation: To fully assess the size and composition of the medical force, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to conduct a new analysis of the required number of active-duty and civilian medical personnel that mitigates known limitations.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To strengthen ongoing efforts to analyze the costs of medical force readiness and establish clinical currency standards, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to take steps to identify and mitigate limitations regarding the standard for maintaining providers' clinical skills, including improving the accuracy of information concerning providers' workload and conducting an analytically rigorous calculation of active-duty providers' time devoted to military-specific responsibilities.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To help achieve DOD's goals for transferring health care into its own facilities and increasing the productivity of active-duty medical providers, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to develop a strategy for achieving these goals that reflects the leading practices of effective federal strategic planning.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To strengthen ongoing efforts within DOD to address the Study's recommendations to use the provider model outputs to inform execution of health care delivery and to refine the model for future use, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to modify DOD's model to reflect the military service of the physicians and military treatment facilities included in the model.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To strengthen any future assessments of additional changes to DOD's network of military treatment facilities, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to describe steps taken to assess the reliability of data supporting the assessment, including, at a minimum, the sources of data, data limitations, and efforts to test data reliability.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To strengthen any future assessments of additional changes to DOD's network of military treatment facilities, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to include in any accompanying cost estimates an appropriate level of detail, all significant costs, and an assessment of the reliability of the data supporting the cost estimate.

    Agency: Department of Defense
    Status: Open

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

    1 open recommendations
    including 1 priority recommendation
    Recommendation: In order to ensure that veterans receive quality care from qualified physicians, the Secretary of Veterans Affairs should direct the Under Secretary for Health to develop and implement a comprehensive oversight strategy that includes ongoing monitoring and evaluations of the contractors' verification of PC3 and Choice physicians' credentials, as well as VHA staff's review of Choice physicians. VHA's oversight should include reviewing documentation and assessing whether the contractors' plans for improving their processes for Choice credentials verification are effective.

    Agency: Department of Veterans Affairs
    Status: Open
    Priority recommendation

    Comments: In June and July 2017, the Veterans Health Administration (VHA) completed separate audit evaluations of both contractors' verification of Patient-Centered Community Care (PC3) and Choice physicians' credentials. This supplements the ongoing monitoring that VHA already had in place for routinely and independently checking the credentials for a sample of PC3 and Choice providers. However, as of October 2017, VHA has not yet implemented a strategy to oversee VHA staff's review of Choice physicians through the VHA Choice Provider Agreement program.
    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

    11 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.
    Recommendation: To improve the design of internal controls over the indirect cost rate-setting process, the Director of ONR should implement the May 2014 policy requiring an annual review of guidance so that internal guidance is updated when changes are made to applicable regulations and procedures to reasonably assure that the guidance reflects current requirements.

    Agency: Department of Defense: Department of the Navy: Office of Naval Research
    Status: Open

    Comments: DOD concurred with this recommendation. In response, DOD stated that the Office of Naval Research (ONR) will comply with its requirement for an annual review of its internal policy on negotiating indirect costs. As of June 15, 2017, no updated information has been provided by the Department of Defense. We will continue to monitor the status of this recommendation.
    Recommendation: To improve the design of internal controls over the indirect cost rate-setting process, the Director of ONR should include in its internal guidance acceptable Defense Contract Audit Agency (DCAA) audit completion time frames and identify supplemental procedures to be performed by negotiators if DCAA cannot perform its audits timely or if DCAA issues a qualified opinion or rescinds one of its previously issued audit opinions, to reasonably assure that the indirect cost rate proposal has been adequately reviewed and the negotiated rate complies with applicable regulations.

    Agency: Department of Defense: Department of the Navy: Office of Naval Research
    Status: Open

    Comments: DOD concurred with this recommendation. In response, DOD stated that the Office of Naval Research's (ONR) internal guidance will be updated to provide more realistic audit report due dates and will include general procedures to be performed by negotiators in the case of untimely audits, qualified opinions, or rescinded opinions. As of June 15, 2017, no updated information has been provided by the Department of Defense. We will continue to monitor the status of this recommendation.
    Recommendation: To improve the design of internal controls over the indirect cost rate-setting process, the Director of ONR should develop detailed procedures for the completion and documentation of supervisory review of the indirect cost rate negotiation process to provide reasonable assurance that required certifications and assurances are obtained and follow-up with the research organization is documented.

    Agency: Department of Defense: Department of the Navy: Office of Naval Research
    Status: Open

    Comments: DOD partially concurred with this recommendation. DOD did not agree that the Office of Naval Research (ONR) lacks procedures to ensure supervisors confirm that negotiators adequately performed and documented key controls. DOD noted that both the primary and secondary supervisors are required to review and approve the Business Clearance Memorandum, which records steps performed by the negotiator. While we agree that the Business Clearance Memorandum documents steps performed by the negotiator, these steps are documented at a high level and do not include detailed procedures for supervisors to follow to reasonably assure that the negotiator has performed and documented all key control activities, such as obtaining all required certifications and assurances. DOD agreed in its response that ONR's Business Clearance Memorandum can be improved and stated that ONR will update it to require the negotiator to cross-reference the review steps to the proposal to facilitate the supervisor's review process. However, it is not clear whether the planned Business Clearance Memorandum revisions will include providing detailed procedures for supervisory review as we recommended. As of June 15, 2017, no updated information has been provided by the Department of Defense. We will continue to monitor the status of this recommendation.
    Recommendation: To improve the design of internal controls over the indirect cost rate-setting process, the Director of ONR should finalize and issue internal guidance for negotiating indirect cost rates with universities and nonprofit organizations, including establishing a time frame for issuance of the internal guidance, to help ensure that the procedures are implemented in a timely manner.

    Agency: Department of Defense: Department of the Navy: Office of Naval Research
    Status: Open

    Comments: DOD concurred with this recommendation. In response, DOD stated that the Office of Naval Research (ONR) is currently updating its internal guidance and currently plans to issue this guidance by December 31, 2016. As of June 15, 2017, no updated information has been provided by the Department of Defense. We will continue to monitor the status of this recommendation.
    Recommendation: To improve the design of internal controls over the indirect cost rate-setting process, the Director of ONR should update ONR's existing process for tracking key milestones in the indirect cost rate-setting process to include information such as when indirect cost rate proposals are overdue and when DCAA's audit reports are due.

    Agency: Department of Defense: Department of the Navy: Office of Naval Research
    Status: Open

    Comments: DOD concurred with this recommendation. In response, DOD stated that the Office of Naval Research will update its existing processes for tracking key milestones to include information such as due dates for rate proposals and DCAA audit reports. As of June 15, 2017, no updated information has been provided by the Department of Defense. We will continue to monitor the status of this recommendation.
    Director: Persons, Timothy M
    Phone: (202) 512-6412

    9 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 Agriculture should direct APHIS to revise reporting forms 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 Agriculture
    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.
    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 Agriculture
    Status: Open

    Comments: In March 2017, United States Department of Agriculture (USDA) officials stated that the department, in coordination with the Department of Health and Human Services (HHS), 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 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 Agriculture should direct APHIS 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 Agriculture
    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. The program continues to develop associated documentation requirements for referring violations to investigative entities and enforcing regulations.
    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: 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: Cosgrove, James C
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To determine the suitability of Medicare's Part B drug payment rate methodology for drugs with coupon programs, Congress should consider (1) granting CMS the authority to collect data from drug manufacturers on coupon discounts for Part B drugs paid based on ASP, and (2) requiring the agency to periodically collect these data and report on the implications that coupon programs may have for this methodology.

    Agency: Congress
    Status: Open

    Comments: When we determine what steps the Congress has taken, we will provide updated information.
    Director: Brenda S. Farrell
    Phone: (202) 512-3604

    7 open recommendations
    Recommendation: To increase oversight of the Army's Warrior Transition Unit program, the Secretary of the Army should direct the Army Surgeon General to assess the Triad of Care model's effectiveness in light of the changes in WTU diagnoses and take the appropriate action.

    Agency: Department of Defense: Department of the Army
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To increase oversight of the Army's Warrior Transition Unit program, the Secretary of the Army should direct the Army Surgeon General to exercise oversight responsibility to track full adherence to selection processes for squad leaders and platoon sergeants, including the requirement to conduct interviews for these positions.

    Agency: Department of Defense: Department of the Army
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To increase oversight of the Army's Warrior Transition Unit program, the Secretary of the Army should direct the Army Surgeon General to develop a mechanism to conduct post-training assessments on squad leaders and platoon sergeants' application of training to the work environment and incorporate the results into the training program.

    Agency: Department of Defense: Department of the Army
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To increase oversight of the Army's Warrior Transition Unit program, the Secretary of the Army should direct the Army Surgeon General to develop plans to adjust staff levels, if needed, to accommodate a potential future surge in demand.

    Agency: Department of Defense: Department of the Army
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To increase oversight of the Army's Warrior Transition Unit program, the Secretary of the Army should direct the Army Surgeon General to establish a process that assigns oversight responsibility for tracking instances in which Commanders make exceptions to WTU entrance criteria so that the Army Surgeon General is aware of the extent Commanders' decisions are consistent with program goals.

    Agency: Department of Defense: Department of the Army
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To increase oversight of the Army's Warrior Transition Unit program, the Secretary of the Army should direct the Army Surgeon General to develop and implement an approach and associated procedures for providing senior leadership, such as the Warrior Transition Command, with complaints information concerning the WTU program and WTU soldiers.

    Agency: Department of Defense: Department of the Army
    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 the best use of resources for managing the medical care of soldiers recovering from serious medical conditions, the Secretary of the Army should direct the Chief of the Army Reserve, in conjunction with the Army Surgeon General, to develop an analysis that compares the costs and benefits of maintaining the current system of Community Care Units with the costs and benefits of expanding the Reserve Component Managed Care program.

    Agency: Department of Defense: Department of the Army
    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 help the Department of Health and Human Services ensure accuracy in Part B drug payment rates, Congress should consider requiring all manufacturers of Part B drugs paid at ASP, not only those with Medicaid drug rebate agreements, to submit sales price data to CMS, and ensure that CMS has authority to request source documentation to periodically validate all such data.

    Agency: Congress
    Status: Open

    Comments: As of August 2017, no action has been taken on this Matter for Congressional Consideration.
    Recommendation: CMS should periodically verify the sales price data submitted by a sample of drug manufacturers by requesting source documentation from manufacturers to corroborate the reported data, either directly or by working with the HHS Office of Inspector General as necessary.

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

    Comments: In 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

    10 open recommendations
    Recommendation: To increase awareness of the health and legal consequences of FGM/C among visa recipients, the Secretary of State should update the Foreign Affairs Manual to require posts located in countries where FGM/C is commonly practiced to directly provide information about FGM/C to nonimmigrant visa recipients in the same manner as is done for immigrant visa recipients.

    Agency: Department of State
    Status: Open

    Comments: The Department of State (State) concurred with this recommendation, and noted in a September 2016 update that it will expand the pool of visa applicants who will receive information on FGM/C. Specifically, once its transition to providing paperwork electronically during the visa application process is complete, State will directly distribute the fact sheet on FGM/C to both immigrant and nonimmigrant visa recipients. According to State, both immigrant and nonimmigrant visa recipients will have to certify that they have read and understood the fact sheet on FGM/C before signing and submitting their respective visa applications. As of August 2017, State has not yet completed these actions.
    Recommendation: To increase awareness of the health and legal consequences of FGM/C among visa recipients, the Secretary of State should update the Foreign Affairs Manual to require posts located outside of the countries where FGM/C is commonly practiced to directly provide information on FGM/C to immigrant and nonimmigrant visa recipients who are nationals of countries where FGM/C is commonly practiced.

    Agency: Department of State
    Status: Open

    Comments: The Department of State (State) concurred with this recommendation, and noted in a September 2016 update that it will expand the pool of visa applicants who will receive information on FGM/C. Specifically, once its transition to providing paperwork electronically during the visa application process is complete, State will directly distribute the fact sheet on FGM/C to both immigrant and nonimmigrant visa recipients who are from or were nationals of a country where FGM/C is commonly practiced. State noted that this change will ensure the widest distribution possible by providing all individuals from countries where FGM/C is commonly practiced with access to the fact sheet on FGM/C regardless of place of application or visa recipient type. As of August 2017, State has not yet completed these actions.
    Recommendation: To make the best use of federal resources directed toward combating FGM/C in the United States, the Attorney General and the Secretaries of Education, Health and Human Services, Homeland Security, and State should each develop a written plan that describes the agency's approach for conducting education and outreach to key stakeholders in the United States regarding FGM/C.

    Agency: Department of Education
    Status: Open

    Comments: The Department of Education (Education) concurred with this recommendation, and noted in a September 2016 update that it will develop a written plan for disseminating relevant FGM/C resources to the agency?s key stakeholder groups. As of August 2017, Education reported that action is still pending.
    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 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 Justice
    Status: Open

    Comments: The Department of Justice (DOJ) concurred with this recommendation, and noted in a September 2016 update that the Human Rights and Special Prosecutions Section of its Criminal Division is taking the lead on developing a written plan on its FGM/C outreach and awareness efforts. As of August 2017, DOJ has not yet developed 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 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 State
    Status: Open

    Comments: The Department of State (State) did not concur with our recommendation, and, as of August 2017, has not indicated that it would implement this recommendation.
    Recommendation: To make the best use of federal resources directed toward combating FGM/C in the United States, the Attorney General and the Secretaries of Education, Health and Human Services, Homeland Security, and State should each communicate the plan with other relevant federal agencies and stakeholder groups, as appropriate.

    Agency: Department of Education
    Status: Open

    Comments: The Department of Education (Education) concurred with this recommendation, and noted in a September 2016 update that it will develop a written plan for disseminating relevant FGM/C resources to the agency?s key stakeholder groups and will explore how to best communicate and coordinate efforts at the federal level. As of August 2017, Education reported that action is still pending.
    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.
    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 Justice
    Status: Open

    Comments: The Department of Justice (DOJ) concurred with this recommendation, and noted in a September 2016 update that the Human Rights and Special Prosecutions Section of its Criminal Division is taking the lead on developing a written plan on its FGM/C outreach and awareness efforts. DOJ also noted that it would communicate its written plan with other relevant federal agencies and stakeholder groups, as appropriate. As of August 2017, DOJ has not yet disseminated 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 State
    Status: Open

    Comments: The Department of State (State) did not concur with our recommendation, and, as of August 2017, has not indicated that it would implement this recommendation.
    Director: Seto Bagdoyan
    Phone: (202) 512-6722

    5 open recommendations
    Recommendation: To help ensure that practitioners who may be ineligible do not possess a controlled substance registration and that practitioners who pose an increased risk of illicit diversion are identified, the Acting Administrator of DEA should take additional actions to strengthen verification controls. Specifically, the Acting Administrator of DEA should develop a legislative proposal requesting authority to require SSNs for all individuals, regardless of whether they hold an individual or business registration.

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

    Comments: In August 2016, DEA told us it is exploring the possibility and practicality of implementing policy or rule changes that would require Social Security Numbers (SSN) from all persons applying for a DEA Registration as a practitioner or mid-level practitioner. We will continue to monitor DEA's progress in implementing this recommendation.
    Recommendation: To help ensure that practitioners who may be ineligible do not possess a controlled substance registration and that practitioners who pose an increased risk of illicit diversion are identified, the Acting Administrator of DEA should take additional actions to strengthen verification controls. Specifically, the Acting Administrator of DEA should develop policies and procedures to validate SSNs and apply the policies and procedures to all new and existing SSNs in the CSA2; such an approach could involve collaborating with SSA to assess the feasibility of checking registrants' SSNs against the Enumeration Verification System.

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

    Comments: In August 2016, DEA told us that it had initiated discussions with the Social Security Administration (SSA) to determine the legality and feasibility of using SSA's Enumeration Verification System (EVS) to verify SSNs provided during the registration process. DEA stated that SSA has informed both GAO and DEA that its current legislative authorities do not authorize SSA to provide the information to DEA. As a a result, DEA stated that legislative action will be required to allow DEA additional access to EVS. As stated in our report, the use of EVS is one possible approach to validate SSNs. We will continue to monitor DEA's progress in implementing this recommendation.
    Recommendation: To help ensure that practitioners who may be ineligible do not possess a controlled substance registration and that practitioners who pose an increased risk of illicit diversion are identified, the Acting Administrator of DEA should take additional actions to strengthen verification controls. Specifically, the Acting Administrator of DEA should develop a legislative proposal to request access to SSA's full death file.

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

    Comments: In August 2016, DEA told us that the Social Security Administration (SSA) determined that it cannot provide data from the full death file to DEA under existing law for use in administering the DEA Registration Process. DEA also said that if legislative changes allow DEA full access to SSA's full death file, DEA will work with SSA to ensure implementation of the new legislative authority. We continue to believe that DEA should develop a legislative proposal to request access to SSA's full death file and we will continue to monitor DEA's progress in implementing this recommendation.
    Recommendation: To help ensure that practitioners who may be ineligible do not possess a controlled substance registration and that practitioners who pose an increased risk of illicit diversion are identified, the Acting Administrator of DEA should take additional actions to strengthen verification controls. Specifically, the Acting Administrator of DEA should identify and implement a cost-effective approach to monitor state licensure and disciplinary actions taken against its registrants; such an approach could include using data sources that contain this information, such as the National Practitioner Data Bank or the Federation of State Medical Boards.

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

    Comments: In August 2016, DEA told us that currently, the Controlled Substance Act and its implementing regulations do not specifically give DEA authority to access state medical licensing boards' databases. DEA also said that it met with representatives of the Federation of State Medical Boards (FSMB) to develop a process that will allow DEA to accomplish the objectives GAO articulated in the draft report. Specifically, DEA said that it is exploring use of the FSMB service to verify the existence and status of state licenses to ensure all applicants for registration who are Doctors of Medicine and Doctors of Osteopathy, or Physician Assistants (in the states that provide this data to FSMB), meet the requirements to possess a DEA Registration. To implement the above described actions, DEA stated it will need to enter into an agreement with FSMB to provide this data in a format that allows real-time access to the data and accommodates the large numbers of applicants for DEA Registrations. DEA also said it obtained information from FSMB to begin the agreement process and is currently obtaining information on data elements that can be used to test user account codes to flag records in the FSMB. We will continue to monitor DEA's progress in implementing this recommendation.
    Recommendation: To help ensure that practitioners who may be ineligible do not possess a controlled substance registration and that practitioners who pose an increased risk of illicit diversion are identified, the Acting Administrator of DEA should take additional actions to strengthen verification controls. Specifically, the Acting Administrator of DEA should assess the cost and feasibility of developing procedures for monitoring registrants' criminal backgrounds, such as conducting matches against federal law-enforcement databases, and document decisions about the approach chosen.

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

    Comments: In August 2016, DEA told us they are in the process of determining the feasibility of implementing actions that would permit DEA to comply with the recommendation utilizing the current legal framework and within reasonable cost parameters. DEA also said that the large volume of DEA registrations and the large number of applications received monthly present extensive technical and fiscal challenges with addressing this recommendation. We will continue to monitor DEA's progress in implementing this recommendation.
    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: Randall B. Williamson
    Phone: (202) 512-7114

    1 open recommendations
    including 1 priority recommendation
    Recommendation: To help provide reasonable assurance that VHA achieves its long-term goal of modernizing its claims processing system, the Secretary of Veterans Affairs should direct the Under Secretary for Health to ensure that the agency develops a sound written plan that includes the following elements: (1) a detailed schedule for when VHA intends to complete development and implementation of each major aspect of its new claims processing system; (2) the estimated costs for implementing each major aspect of the system; and (3) the performance goals, measures, and interim milestones that VHA will use to evaluate progress, hold staff accountable for achieving desired results, and report to stakeholders the agency's progress in modernizing its claims processing system.

    Agency: Department of Veterans Affairs
    Status: Open
    Priority recommendation

    Comments: As of June 2017, VHA's Office of Community Care is in the process of consolidating VA's community care programs, and as part of this process it plans to transition to a third party administrator for the purposes of claims processing. While an active procurement is underway, VHA still needs to develop a written plan to fully implement this recommendation. VHA's written plan must include details about the schedule, cost estimates, performance goals, and interim milestones associated with transitioning to a third party administrator for the purposes of processing claims for VA community care.
    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: Williamson, Randall B
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: To develop and maintain medical sharing expertise within the network contracting offices, the Secretary of Veterans Affairs should direct the Under Secretary for Health to create a plan for increasing the retention of contracting officers that work in medical sharing teams.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: In March 2017, VHA reported that it is working on creating a plan for increasing the retention of contracting officers that work in medical sharing teams. The Medical Sharing Office (MSO) has taken several steps including conducting research on possible ways to minimize or eliminate steps within its existing plan and expanding the number of topical training provided virtually network contracting offices to develop competency in VHA Health Care 1102 staff. In addition, VHA reported they are developing a training schedule to ensure newly deployed interns have received the training and resource to successfully conduct health care contracts if they are assigned to health care resources team and continuing to collaborate with the field to ensure awareness of MSO support and assistance.
    Recommendation: To ensure VHA effectively communicates with its affiliates regarding SSACs, the Secretary of Veterans Affairs should direct the Under Secretary for Health to reach out to all of its affiliates, identify any concerns, and determine the most effective method of communicating with affiliates regarding SSAC development.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: In March 2017, the VHA reported that it plans to have an Academic Affiliate Contracting Forum on August 15-16, 2017 in Nashville, TN or Dallas, TX for VHA staff responsible for health care contracts and University affiliates. The purpose of the Forum is to strengthen and advance the collaborative partnership for providing service to Veterans; share perspectives; and enhance awareness about processes, procedures and tools that will help make contracting processes faster and easier for all parties.
    Director: Randall B. Williamson
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To enhance oversight of access to mental health care and help ensure that servicemembers have timely access to mental health care, the Secretary of Defense should direct the Assistant Secretary of Defense for Health Affairs to establish an access standard for mental health follow-up appointments and regularly monitor data on these appointments.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Cindy Brown Barnes
    Phone: (202) 512-7215

    3 open recommendations
    Recommendation: To strengthen DOL's efforts to ensure employers protect the safety and health of workers at meat and poultry plants, the Secretary of Labor should direct the Assistant Secretary for Occupational Safety and Health, working together with the Commissioner of Labor Statistics as appropriate, to develop and implement a cost-effective method for gathering more complete data on musculoskeletal disorders.

    Agency: Department of Labor
    Status: Open

    Comments: DOL generally agreed with this recommendation and stated that its implementation would make a difference in working conditions in the meat and poultry industry. The agency also noted that resource constraints may make it difficult to implement.
    Recommendation: To develop a better understanding of meat and poultry sanitation workers' injuries and illnesses, the Secretary of Labor should direct the Assistant Secretary for Occupational Safety and Health and the Commissioner of Labor Statistics to study how they could regularly gather data on injury and illness rates among sanitation workers in the meat and poultry industry.

    Agency: Department of Labor
    Status: Open

    Comments: DOL generally agreed with this recommendation and stated that its implementation would make a difference in working conditions in the meat and poultry industry. The agency also noted that resource constraints may make it difficult to implement.
    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: Brenda S. Farrell
    Phone: (202) 512-3604

    7 open recommendations
    Recommendation: The Secretary of Defense should direct the Under Secretary of Defense for Personnel and Readiness to collect and monitor deployed civilians' perceptions related to mental health care.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Secretary of Defense should direct the Under Secretary of Defense for Personnel and Readiness to leverage recommendations made by the RAND Corporation in its 2014 report on mental health stigma in the military to update and clarify policies as needed to remove stigmatizing provisions, such as career restrictions that may be too limiting for individuals who have received mental health care.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Secretary of Defense should direct the Under Secretary of Defense for Personnel and Readiness to establish a clear, consistent definition of those barriers to care generally understood by DOD as "mental health care stigma," to include explanations of its causes or contributing risk factors and ways that stigma is apparent in behaviors and policies.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Secretary of Defense should direct the Under Secretary of Defense for Personnel and Readiness to establish goals for efforts to address barriers to care generally understood by DOD as "stigma reduction efforts," and performance measures that link to these goals.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Secretary of Defense should direct the Under Secretary of Defense for Personnel and Readiness to develop a method to collect and analyze information on barriers to seeking mental health care, including stigma, so that reliable data may be gathered and used to measure the effectiveness of stigma reduction efforts over time.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Secretary of Defense should direct the Under Secretary of Defense for Personnel and Readiness to designate an entity to coordinate efforts to reduce mental health care stigma, among other barriers to care.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Secretary of Defense should direct the Under Secretary of Defense for Intelligence to reissue consolidated guidance, incorporating subsequent updates for the denial or suspension of access to classified information and for assignment to sensitive duties based solely on information about mental health care.

    Agency: Department of Defense
    Status: Open

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

    28 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 Agriculture should revise existing department policies for managing hazardous biological agents in high-containment laboratories to contain specific requirements for reporting laboratory incidents to senior department officials, including the types of incidents that should be reported, to whom, and when, or direct the Administrator of the Food Safety and Inspection Service to develop agency policies that contain these requirements.

    Agency: Department of Agriculture
    Status: Open

    Comments: In October 2016 USDA reported that its science and safety councils chartered a joint biorisk management policy committee to oversee the revisions of existing policies to include department-wide incident reporting requirements and time frames. USDA also reported that FSIS will collaborate with the department to ensure that FSIS policies comply with USDA reporting requirements. USDA did not provide an anticipated completion date for revising departmental polices.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Agriculture should review and update outdated department policies for managing hazardous biological agents in high-containment laboratories and direct the Administrators of the Animal and Plant Health Inspection Service (APHIS) and Agricultural Research Service to update their policies and, in the case of APHIS, establish a regular review schedule.

    Agency: Department of Agriculture
    Status: Open

    Comments: In October 2016, USDA reported that the science and safety councils' joint biorisk management policy committee will review and update the existing outdated USDA policies. In addition, USDA reported that APHIS will review agency policies for biological laboratories every 3-5 years or sooner, if necessary, and that this schedule will be reflected in USDA policy. USDA did not provide an anticipated completion date for reviewing and updating departmental polices. USDA reported that ARS has finalized its policies for its institutional biological safety committee in April 2016. Once all USDA and component agency policies have been updated and review schedules established, we will close this recommendation.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Agriculture should routinely analyze results of the department's laboratory inspections and incident reports to identify potential trends that may highlight recurring laboratory safety or security issues and share lessons learned with laboratory personnel.

    Agency: Department of Agriculture
    Status: Open

    Comments: In October 2016, USDA reported that the joint biorisk management policy committee will oversee efforts to collect and analyze laboratory inspection and incident reports and share these reports and critical analyses with USDA senior leadership. USDA did not provide an anticipated start date for analyzing reports and sharing analyses with senior departmental officials. USDA stated that the joint biorisk committee also serves as an information-sharing platform across USDA agencies and, as such, is positioned to share lessons learned from analyses of inspection and incident reports with laboratory personnel as necessary. USDA also provided additional information on APHIS, ARS, and FSIS planned or ongoing inspection and incident report analyses.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Agriculture should require routine reporting of the results of department, agency, and select agent laboratory inspections to senior department officials.

    Agency: Department of Agriculture
    Status: Open

    Comments: In October 2016, USDA reported that the joint biorisk management policy committee will oversee efforts to revise existing departmental regulations to include requirements for routine reporting of inspection results to senior USDA officials. USDA did not provide an anticipated completion date for revising existing departmental regulations. USDA also provided additional information on APHIS, ARS, and FSIS planned or ongoing reporting of inspection results or revisions of agency policies to require such reporting.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Agriculture should require routine reporting of incidents at agency laboratories to senior department officials.

    Agency: Department of Agriculture
    Status: Open

    Comments: In October 2016, USDA reported that the joint biorisk management policy committee will oversee efforts to revise existing departmental regulations to include requirements for routine reporting of laboratory incidents to senior USDA officials. USDA did not provide an anticipated completion date for revising existing departmental regulations. USDA also provided additional information on APHIS, ARS, and FSIS planned or ongoing incident reporting or revisions of agency policies to require such reporting.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Defense should revise existing department policies for managing hazardous biological agents in high-containment laboratories to contain specific requirements for inventory control for all of DOD's high-containment laboratories, not just for its select agent-registered laboratories, or direct the Secretaries of the Air Force, Army, and Navy to revise their existing, respective policies to contain these requirements.

    Agency: Department of Defense
    Status: Open

    Comments: In June 2016, DOD noted that its comments on the final report--in which it agreed with all of our findings and recommendations for the department--had not changed. However, DOD did not provide us with an update on its status in implementing these 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 Defense should direct the Secretaries of the Air Force and Army to review and update their respective outdated policies for managing hazardous biological agents in high-containment laboratories.

    Agency: Department of Defense
    Status: Open

    Comments: In June 2016, DOD noted that its comments on the final report--in which it agreed with all of our findings and recommendations for the department--had not changed. However, DOD did not provide us with an update on its status in implementing these 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 Defense should routinely analyze agencies' inspection results and incident reports to identify potential trends that may highlight recurring laboratory safety or security issues and share lessons learned with laboratory personnel, or direct the Secretaries of the Army and Navy to do so.

    Agency: Department of Defense
    Status: Open

    Comments: In June 2016, DOD noted that its comments on the final report--in which it agreed with all of our findings and recommendations for the department--had not changed. However, DOD did not provide us with an update on its status in implementing these 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 Defense should require routine reporting of the results of Air Force, Army, and Navy inspections of non-select agent registered laboratories to senior department officials.

    Agency: Department of Defense
    Status: Open

    Comments: In June 2016, DOD noted that its comments on the final report--in which it agreed with all of our findings and recommendations for the department--had not changed. However, DOD did not provide us with an update on its status in implementing these 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 Defense should require routine reporting of laboratory incidents at Air Force, Army, and Navy non-select agent registered laboratories to senior department officials.

    Agency: Department of Defense
    Status: Open

    Comments: In June 2016, DOD noted that its comments on the final report--in which it agreed with all of our findings and recommendations for the department--had not changed. However, DOD did not provide us with an update on its status in implementing these 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 Defense should direct the Secretaries of the Army and Navy to require reporting of agency and select agent laboratory inspection results to senior agency officials.

    Agency: Department of Defense
    Status: Open

    Comments: In June 2016, DOD noted that its comments on the final report--in which it agreed with all of our findings and recommendations for the department--had not changed. However, DOD did not provide us with an update on its status in implementing these 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 Defense should develop time frames for the 19 specific recommendations from the July 2015 review, or direct the Secretary of the Army to do so.

    Agency: Department of Defense
    Status: Open

    Comments: In June 2016, DOD noted that its comments on the final report--in which it agreed with all of our findings and recommendations for the department--had not changed. However, DOD did not provide us with an update on its status in implementing these 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 Energy should revise existing department policies for managing hazardous biological agents in high-containment laboratories to contain specific requirements for inspections, or direct the Administrator of the National Nuclear Security Administration and the Director of the Office of Science to develop agency policies that contain this requirement.

    Agency: Department of Energy
    Status: Open

    Comments: In August 2016, DOE reported that it is revising department policy for its select agent and toxin work to highlight oversight of facilities working with these agents and toxins. DOE will solicit input from NNSA, the Office of Science, and its biosurety executive team to determine if specific inspection requirements should be included in the select agent, or other department or agency policies. DOE provided us with information as to other department policies and regulations that allow for inspections. DOE plans to complete its efforts by the end of July 2017. We maintain that DOE should make laboratory inspection requirements explicit and that these requirements apply to all high-containment laboratories, not just those registered with the select agent program.
    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 Energy should review and update its outdated policies for managing hazardous biological agents in high-containment laboratories.

    Agency: Department of Energy
    Status: Open

    Comments: In August 2016, DOE reported that it is updating its outdated select agent policy and plans to complete this update by the end of July 2017.
    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 Administrator of the Environmental Protection Agency (EPA) should revise existing EPA policies for managing hazardous biological agents in high-containment laboratories to contain specific requirements for inventory control, or direct the Director of the Office of Pesticide Programs to incorporate this requirement into its policy.

    Agency: Environmental Protection Agency
    Status: Open

    Comments: EPA agreed with this recommendation in its February 2016 comments on the draft report, but maintains that agency, or senior-level policies, exist that include this requirement. EPA officials cited a Microbiology Laboratory Branch standard operating procedure (SOP) as containing inventory control requirements for the agency's one high-containment laboratory. However, in July 2016, EPA officials told us that it disagreed with our assessment that the SOP, as a laboratory-level document, was insufficient to meet our expectations for senior-level policies. In November 2016, EPA officials reiterated its position stating that the SOP had been approved by senior agency management and, as the requirements in it are universally applied by all laboratory staff, appropriately represents an agency-level policy. EPA further noted that the Office of Pesticide Policy, in which the Microbiology Laboratory Branch is located, is a sub-office within EPA's Office of Chemical Safety and Pollution Prevention (OCSPP), an Assistant Administrator-level office. We continue to believe that senior-level policies--in this case, either those policies issued at the EPA level or at the OCSPP/OPP level--that include all of the policy elements we analyzed reflect critical management commitment to and support for a culture of laboratory safety throughout the organization, regardless of the number of agency laboratories.
    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 Administrator of EPA should review and update EPA's outdated policies for managing hazardous biological agents in high-containment laboratories and establish a regular schedule for reviewing and updating EPA and Office of Pesticide Programs policies.

    Agency: Environmental Protection Agency
    Status: Open

    Comments: In July 2016, EPA reported that the policies and procedures for both the facility that houses its microbiology laboratory and the laboratory itself are reviewed and updated on a bi-yearly or yearly basis consistent with the EPA schedules for biosafety and laboratory plans set in policy. However, EPA did not provide us with the policy that sets the EPA schedules. In addition, our analysis focused on policy documents issued by EPA or its senior-level offices, such as EPA's Safety, Health, and Environmental Management Program manual, dated November 2012. When we analyzed that policy for the report, we were unable to determine whether it was up-to-date because it did not include a review and update schedule or a specific recertification date. As of November, 2016, EPA maintains that this recommendation has been completed, because the office revised the standard operating procedure that provides guidance for establishing the receipt, expiration dates, and disposal of biological inventory used in the laboratory. As of April 2017, we have reached out to EPA for documentation of the actions the agency stated it has taken. Until received, we continue to believe that EPA action on this recommendation is still needed, such as by providing an updated EPA-level safety manual that includes a schedule for reviewing and updating, or providing EPA's schedule set in policy, so long as it also applies to agency- or senior office-level policies.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Administrator of EPA should require routine reporting of the results of department, agency, and select agent laboratory inspections to senior department officials.

    Agency: Environmental Protection Agency
    Status: Open

    Comments: EPA agreed with this recommendation in its February 2016 comments on the draft report. ?In July 2016, EPA reported that its high-containment laboratory will notify senior officials within 3 weeks of any laboratory inspection findings. ?This is a positive step. We are waiting for EPA to provide us with supporting documentation.
    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.
    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 the Interior should develop department policies, or direct the Directors of Fish and Wildlife Service and U.S. Geological Survey to develop agency 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--and specific requirements for roles and responsibilities, training, inventory control, and inspections.

    Agency: Department of the Interior
    Status: Open

    Comments: In July 2016, DOI reported that the Fish and Wildlife Service and U.S. Geological Survey will develop agency-level policies that contain the key elements GAO identified. DOI did not provide us with a time frame for these activities.
    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 the Interior should routinely analyze the results of the agency's laboratory inspections and incident reports to identify potential trends that may highlight recurring laboratory safety or security issues and share lessons learned with laboratory personnel, or direct the Directors of Fish and Wildlife Service and U.S. Geological Survey to do so.

    Agency: Department of the Interior
    Status: Open

    Comments: In July 2016, DOI reported that its Biosafety Working Group, composed of officials across the department, including Fish and Wildlife Service and U. S. Geological Survey, is developing an automated process for analyzing results of laboratory inspections and incident reports to identify safety and security trends. The working group is also developing a process to share information gleaned from these analyses, including lessons learned, with laboratory personnel in a timely manner. DOI did not provide us with a time frame for these activities.
    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 the Interior should require routine reporting of the results of agency and select agent inspections to senior department officials.

    Agency: Department of the Interior
    Status: Open

    Comments: In July 2016, DOI reported that in according with the reporting requirements it plans to incorporate into agency-level policies in response to our first recommendation, Fish and Wildlife Service and U. S. Geological survey will be required to submit routine or periodic reports of the results of agency and select agent inspections to the department's designated agency safety and health official.
    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 the Interior should direct the Director of the U.S. Geological Survey to require routine reporting of the results of agency and select agent laboratory inspections to senior agency officials.

    Agency: Department of the Interior
    Status: Open

    Comments: In July 2016, DOI reported that the U. S. Geological Survey will modify and expand its existing policies to require reporting of agency and select agent inspection results to senior USGS officials.
    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 Veterans Affairs 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--and requirements for inventory control for all of its high-containment laboratories, including its select agent-registered clinical laboratory, or direct the Under Secretary of Health to incorporate these requirements into its policies.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: In June 2016, VA reported that while it has policies for reporting laboratory incidents at the local level (VA medical center or laboratory level), VA plans to develop a national level policy for reporting laboratory incidents to senior department officials, including the types of incidents to report, to whom, and when. VA will convene a task force for the purposes of developing such a policy and anticipates that the task force will finalize its policy by March 2018. In June 2017, VA reported that the task force concluded that VA's existing emergency management plan contained all of the necessary requirements for laboratory incident reporting. However, VA has not provided GAO with the emergency management plan. VA further noted that a intradepartmental memorandum was sufficient for making employees aware of such policy requirements in the emergency plan and that such a memorandum was drafted and was being processed for dissemination throughout VA, with an anticipated completion date of August 2017.
    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 Veterans Affairs should direct the Under Secretary of Health to review and update outdated agency policies for managing hazardous biological agents in high-containment laboratories.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VA updated and finalized its outdated policy for its clinical laboratories in February 2016. In July 2016, VA reported that it has begun updating its policies for its research laboratories and anticipated finalizing them in 6 months. In June 2017, VA reported that its policies for its research laboratories remain under review and revision, with an anticipated completion date of December 2017.
    Director: Debra A. Draper
    Phone: (202) 512-7114

    1 open recommendations
    including 1 priority recommendation
    Recommendation: The Secretary of Veterans Affairs should direct the Under Secretary for Health to monitor the full amount of time newly enrolled veterans wait to be seen by primary care providers, starting with the date veterans request they be contacted to schedule appointments. This could be accomplished, for example, by building on the data collection efforts currently being implemented under the "Welcome to VA" program.

    Agency: Department of Veterans Affairs
    Status: Open
    Priority recommendation

    Comments: In March 2016, GAO recommended that VA monitor the full amount of time newly enrolled veterans wait to be seen by primary care providers, starting with the date veterans request they be contacted to schedule appointments. VA concurred with this recommendation, and in June 2017, reported to GAO that it had taken actions to address this recommendation. Specifically, VA indicated that it revised an internal report to help identify and document all newly enrolled veterans and monitor their appointment request status. The report is intended to enable VHA and its medical centers to oversee the enrollment and appointment process by tracking the following timeframes: (1) application to enrollment, (2) enrollment to initial contact, (3) initial contact to primary care appointment, and (4) total time from application from appointment. However, VA also indicated in its response that it does not have data that captures application dates for all newly enrolled veterans. As a result, this report cannot be used to consistently monitor the full amount of time these veterans wait to be seen by primary care providers. To fully implement this recommendation VA needs to capture the application date for all newly enrolled veterans. Upon receiving further information about how and when VA plans to capture this information, we will assess whether VA's actions are sufficient to warrant closure of this recommendation.
    Director: Andrew Sherrill
    Phone: (202) 512-7215

    1 open recommendations
    including 1 priority recommendation
    Recommendation: To help determine whether current efforts are effective or if additional action may be needed, such as development of a workplace violence prevention standard for health care employers, the Secretary of Labor should direct the Assistant Secretary for Occupational Safety and Health to develop and implement cost-effective ways to assess the results of the agency's efforts to address workplace violence.

    Agency: Department of Labor
    Status: Open
    Priority recommendation

    Comments: According to OSHA officials, the agency has a study underway that will review OSHA's workplace violence enforcement cases in health care to better understand the obstacles OSHA compliance officers encountered during these investigations and identify factors which led to citations. OSHA expects the final report to be completed in 2017, which will help its compliance officers develop citations in workplace violence cases. In addition, in December 2016, OSHA published a Request for Information on Preventing Workplace Violence in Healthcare and Social Assistance (RFI), which will help the agency identify workplace violence prevention requirements that could be effective and economical if a regulation were to be developed. The comment period closed in April 2017. In June 2017, the agency reported that it is reviewing the information received through the RFI. As of August 2017, the Prevention of Workplace Violence in Health Care and Social Assistance rulemaking status is classified as a long term regulatory action. To fully implement this recommendation, DOL should complete its ongoing study to better understand the obstacles OSHA compliance officers encountered during these investigations and identify factors that led to citations; and analyze the input received from the RFI to determine whether regulatory action is needed.
    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: Melissa Emrey-Arras
    Phone: (617) 788-0534

    4 open recommendations
    including 2 priority recommendations
    Recommendation: To support the collection of complete and accurate safety and health information on the condition of BIE school facilities nationally, the Secretary of the Interior should direct the Assistant Secretary-Indian Affairs to ensure that all BIE schools are annually inspected for safety and health, as required by its policy, and that inspection information is complete and accurate. This could include: (1) Analyzing the key challenges to ensuring that all BIE schools are inspected, as well as implementing a plan to mitigate those challenges. (2) In the interim, prioritizing inspections at schools where facility conditions may pose a greater risk to students--such as schools with dormitories or those that have not been recently inspected.

    Agency: Department of the Interior
    Status: Open
    Priority recommendation

    Comments: In September 2016, Indian Affairs reported that it had completed annual safety inspections at all BIE school locations for the first time in at least 15 years. In late August 2017, officials reported that Indian Affairs was on course to complete all inspections in 2017 but did not provide documentation on its progress. Further, Indian Affairs stated that it understands the need to ensure that completing school inspections does not detract from inspection quality. However, as of August 2017 we had not received documentation that the agency had taken steps to ensure that its safety personnel collect inspection information that is complete and accurate. We believe the steps Indian Affairs has taken to prioritize the completion of safety inspections at all BIE schools are important ones. However, we believe it is also important that the agency take specific steps to ensure that the inspection information it collects is complete and accurate. Without complete and accurate information, BIE schools may not have the information they need on potential safety hazards, which may endanger students and staff. We will continue to monitor Indian Affairs' efforts to implement this recommendation.
    Recommendation: To support the collection of complete and accurate safety and health information on the condition of BIE school facilities nationally, the Secretary of the Interior should direct the Assistant Secretary-Indian Affairs to revise its inspection guidance and tools to ensure that they are comprehensive and up-to-date; require that regional safety inspectors use them to ensure all vital areas are covered, such as school fire protection; and monitor safety inspectors' use of procedures and tools across regions to ensure they are consistently adopted.

    Agency: Department of the Interior
    Status: Open

    Comments: In June 2016, Indian Affairs implemented new comprehensive guidelines for safety and health inspections and testing and maintaining fire prevention systems. The guidelines, which we reviewed, detail specific inspection procedures which all relevant safety personnel are required to follow. Indian Affairs provided training in May and June of 2017 to relevant staff on using the guidelines. According to the guidelines, Indian Affairs' safety office is required to monitor safety staff compliance with the new inspection procedures. We believe these are important steps to ensuring that regional inspectors have clear procedures in place for conducting BIE school inspections. However, Indian Affairs has not provided us with documentation, such as a plan, for how its safety office will monitor inspections to ensure procedures are consistently followed by inspectors across regions. For example, such monitoring could help ensure that all inspectors conduct a close out meeting with relevant school staff at the conclusion of an on-site safety inspection. We believe such monitoring is important to ensure that the practices of its safety inspectors consistently align with its procedures and result in inspection information that is complete and accurate. We will continue to monitor Indian Affairs' efforts to implement this recommendation.
    Recommendation: To ensure that all BIE schools are positioned to address safety and health problems with their facilities and provide student environments that are free from hazards, the Secretary of the Interior should direct the Assistant Secretary-Indian Affairs to develop a plan to build schools' capacity to promptly address safety and health problems with facilities. Such a plan could prioritize assistance to schools to improve the expertise of facility staff to maintain and repair school buildings.

    Agency: Department of the Interior
    Status: Open
    Priority recommendation

    Comments: Interior agreed with this recommendation. As of late August 2017, Indian Affairs had not provided us any documentation that it had taken steps to implement our recommendation. We will continue to monitor Indian Affairs' efforts to implement this recommendation.
    Recommendation: To ensure that all BIE schools are positioned to address safety and health problems with their facilities and provide student environments that are free from hazards, the Secretary of the Interior should direct the Assistant Secretary-Indian Affairs to consistently monitor whether schools have established required safety committees.

    Agency: Department of the Interior
    Status: Open

    Comments: In July 2017, Indian Affairs officials told us that they are developing a system that would enable them to monitor whether schools have established required safety committees. They also noted that Indian Affairs' new inspection procedures require that inspectors check to see if schools have established safety committees. Finally, the BIE Director reported that he would send a memorandum to all BIE schools reminding them about Indian Affairs' requirement to establish safety committees. We will review and evaluate Indian Affairs' actions when the agency has provided us with supporting documentation.
    Director: Rebecca Gambler
    Phone: (202) 512-8777

    1 open recommendations
    Recommendation: To enhance Department of Homeland Security's (DHS) U.S. Immigration and Customs Enforcement's (ICE) ability to make more effective business decisions across immigration detention facilities with respect to the provision of medical care, the Secretary of Homeland Security should direct ICE to track inspection results and conduct analyses of oversight data over time, by standards, and by facility type.

    Agency: Department of Homeland Security
    Status: Open

    Comments: As of May 2017, ICE has not provided a status update regarding the implementation of this recommendation. We will provide updated information after confirming any agency actions.
    Director: Debra A. Draper
    Phone: (202) 512-7114

    12 open recommendations
    Recommendation: The Secretaries of Veterans Affairs and Defense should collaborate to establish FHCC-specific selection criteria for the FHCC facility director and deputy director positions that include responsibilities and leadership competencies for effective collaboration.

    Agency: Department of Defense
    Status: Open

    Comments: We will update the status of this recommendation when we determine what steps the agency has taken to implement it.
    Recommendation: The Secretaries of Veterans Affairs and Defense should collaborate to establish FHCC-specific selection criteria for the FHCC facility director and deputy director positions that include responsibilities and leadership competencies for effective collaboration.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: We will update the status of this recommendation when we determine what steps the agency has taken to implement it.
    Recommendation: The Secretaries of Veterans Affairs and Defense should collaborate to ensure that the evaluation of the leadership performance at the FHCC is carried out jointly between VA and DOD.

    Agency: Department of Defense
    Status: Open

    Comments: We will update the status of this recommendation when we determine what steps the agency has taken to implement it.
    Recommendation: The Secretaries of Veterans Affairs and Defense should collaborate to ensure that the evaluation of the leadership performance at the FHCC is carried out jointly between VA and DOD.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: We will update the status of this recommendation when we determine what steps the agency has taken to implement it.
    Recommendation: The Secretaries of Veterans Affairs and Defense should collaborate to perform data-driven strategic workforce planning prior to implementing any future integration efforts.

    Agency: Department of Defense
    Status: Open

    Comments: We will update the status of this recommendation when we determine what steps the agency has taken to implement it.
    Recommendation: The Secretaries of Veterans Affairs and Defense should collaborate to perform data-driven strategic workforce planning prior to implementing any future integration efforts.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: We will update the status of this recommendation when we determine what steps the agency has taken to implement it.
    Recommendation: The Secretaries of Veterans Affairs and Defense should collaborate to determine how best to fill the FHCC's short-term staffing needs, including any additional statutory authorities that might be necessary to implement the desired approach.

    Agency: Department of Defense
    Status: Open

    Comments: We will update the status of this recommendation when we determine what steps the agency has taken to implement it.
    Recommendation: The Secretaries of Veterans Affairs and Defense should collaborate to determine how best to fill the FHCC's short-term staffing needs, including any additional statutory authorities that might be necessary to implement the desired approach.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: We will update the status of this recommendation when we determine what steps the agency has taken to implement it.
    Recommendation: The Secretaries of Veterans Affairs and Defense should collaborate to resolve differences in IT network security standards to the extent possible prior to implementing any future integration efforts.

    Agency: Department of Defense
    Status: Open

    Comments: We will update the status of this recommendation when we determine what steps the agency has taken to implement it.
    Recommendation: The Secretaries of Veterans Affairs and Defense should collaborate to resolve differences in IT network security standards to the extent possible prior to implementing any future integration efforts.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: We will update the status of this recommendation when we determine what steps the agency has taken to implement it.
    Recommendation: The Secretaries of Veterans Affairs and Defense should direct FHCC leadership to provide additional guidance on the patient priority system to all staff responsible for approving consults and ensure that the monthly capability and capacity reports include information on all categories of FHCC patients defined by the patient priority system.

    Agency: Department of Defense
    Status: Open

    Comments: We will update the status of this recommendation when we determine what steps the agency has taken to implement it.
    Recommendation: The Secretaries of Veterans Affairs and Defense should direct FHCC leadership to provide additional guidance on the patient priority system to all staff responsible for approving consults and ensure that the monthly capability and capacity reports include information on all categories of FHCC patients defined by the patient priority system.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: We will update the status of this recommendation when we determine what steps the agency has taken to implement it.
    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: Debra Draper
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: The Secretary of Defense should direct the Secretary of the Army to implement processes to review and monitor the Army military treatment facility prescribing practices for medications discouraged under the PTSD guideline and address identified deviations.

    Agency: Department of Defense
    Status: Open

    Comments: We requested an update on the status of this recommendation. As of June 21, 2016, we are waiting for a response from DOD.
    Director: James Cosgrove
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: In order to prevent the shift of services from physician offices to HOPDs from increasing costs for the Medicare program and beneficiaries, Congress should consider directing the Secretary of HHS to equalize payment rates between settings for E/M office visits--and other services that the Secretary deems appropriate--and to return the associated savings to the Medicare program.

    Agency: Congress
    Status: Open

    Comments: When we determine what steps the Congress has taken, we will provide updated information.
    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: Gerald Dillingham, Ph.D
    Phone: (202) 512-2834

    1 open recommendations
    Recommendation: To help improve the U.S. aviation sector's preparedness for future communicable disease threats from abroad, the Secretary of Transportation should work with relevant stakeholders, such as the Department of Health and Human Services, to develop a national aviation-preparedness plan for communicable disease outbreaks. Such a plan could establish a mechanism for coordination between the aviation and public health sectors and provides clear and transparent planning assumptions for a variety of types and levels of communicable disease threats.

    Agency: Department of Transportation
    Status: Open

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

    1 open recommendations
    Recommendation: To be able to identify and address problems that may occur and thus help ensure a smooth transition, the Secretary of Defense should require the Defense Health Agency ensure that planning documents for the expansion include specific requirements to continuously monitor affected beneficiaries, including whether (1) covered medications are available and filled in a timely and accurate manner through mail order and across MTF pharmacies; and (2) beneficiaries are satisfied with the transition to mail order and MTF pharmacies.

    Agency: Department of Defense
    Status: Open

    Comments: As of April 2016, DOD has not provided information that it plans to separately track through mail order and military treatment facilities the availability, timeliness, and accuracy of prescriptions filled by beneficiaries affected by the expansion of the TRICARE pharmacy pilot. Similarly, DOD has not provided information that it plans to separately track through mail order and military treatment facilities the satisfaction of beneficiaries affected by the expansion of the TRICARE pharmacy pilot.
    Director: Debra Draper
    Phone: (202) 512-7114

    3 open recommendations
    including 2 priority recommendations
    Recommendation: To help ensure the effective recruitment and retention of nurses across VA medical centers, the Secretary of Veterans Affairs should direct the Under Secretary for Health to develop a periodic reporting process to help monitor VA medical center compliance with the policies and procedures for each of its key recruitment and retention initiatives.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VHA convened a taskforce with accompanying charter to address all three of GAO's recommendations, including medical center compliance with policies and procedures for the key recruitment and retention initiatives. The taskforce consists of workgroups that are charged with reviewing current processes for reporting on compliance for the eight recruitment and retention initiatives we identified in our report, identifying opportunities for improvement, and developing recommendations to optimize medical centers' reporting on compliance. Based on the workgroup recommendations, VHA will generate and implement program-specific approaches for reporting on compliance of the initiatives. As of March 2017, the workgroups have reviewed, or are in the process of reviewing, compliance reporting processes for all eight initiatives. VHA anticipates implementing compliance reporting processes by October 2017.
    Recommendation: To help ensure the effective recruitment and retention of nurses across VA medical centers, the Secretary of Veterans Affairs should direct the Under Secretary for Health to evaluate the adequacy of training resources provided to all nurse recruiters at VA medical centers to ensure that they have the tools and information to perform their duties efficiently and effectively.

    Agency: Department of Veterans Affairs
    Status: Open
    Priority recommendation

    Comments: VHA convened a taskforce with accompanying charter to address all three recommendations, including evaluating training resources provided to nurse recruiters. VHA stated that it held nurse recruiter training in April 2016 to address immediate training needs and incorporated survey results and recommendations from the field on the training at an August 2016 curriculum redesign meeting. VHA's next national nurse recruiter training sessions are to be held in April and November 2017, as well as four additional intermittent training sessions. In October 2016, VHA stated that it had established a national nurse recruitment division that will focus on national oversight, guidance, training, monitoring of nursing workforce and recruitment matters but did not provide an anticipated date for when it would be able to staff and stand up the new division. VHA noted that it will pursue an external study examining the effectiveness of the role of the nurse recruiter in VHA and a comparison of the effectiveness of nurse recruiters assigned to nurses offices versus those assigned to human resources offices. However, VHA did not provide any information on when it plans to pursue or complete such an evaluation. VHA also noted that the taskforce is exploring improved data collection tools and methods to routinely evaluate the adequacy and effectiveness of training resources provided to nurse recruiters at VA medical centers.
    Recommendation: To help ensure the effective recruitment and retention of nurses across VA medical centers, the Secretary of Veterans Affairs should direct the Under Secretary for Health to conduct a system-wide evaluation of VHA's key nurse recruitment and retention initiatives, to determine the overall effectiveness of these initiatives, including any needed improvements, and communicate results and information in a timely manner to relevant stakeholders.

    Agency: Department of Veterans Affairs
    Status: Open
    Priority recommendation

    Comments: VHA convened a taskforce with accompanying charter to address all three of GAO's recommendations, including conducting a system-wide evaluation of VHA's key nurse recruitment and retention initiatives and identifying areas for improvement. The taskforce consists of workgroups that are charged with reviewing current processes for reporting on compliance for the eight recruitment and retention initiatives we identified in our report, identifying opportunities for improvement, and developing recommendations to optimize medical centers' reporting on compliance. Based on the workgroup recommendations, VHA will generate and implement program-specific approaches for reporting on compliance of the initiatives. As of March 2017, taskforce has evaluated, or is in the process of evaluating, the effectiveness of each of the eight initiatives. VHA anticipates completing these evaluations by October 2017. However, VHA did not provide any information on its efforts to evaluate the overall effectiveness of the key initiatives in meeting VHA's system-wide nurse recruitment and retention goals.
    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: Brenda S. Farrell
    Phone: (202) 512-3604

    3 open recommendations
    including 3 priority recommendations
    Recommendation: To provide decision makers with appropriate and more complete information on the continuing implementation, management, and oversight of the DHA, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to develop a comprehensive requirements assessment process that accounts for needed future skills through the consideration of potential organizational changes and helps ensure appropriate consideration of workforce composition through the determination of the final status of military personnel within the DHA.

    Agency: Department of Defense
    Status: Open
    Priority recommendation

    Comments: As of April 2017, DOD has taken some steps to implement this action. According to an April 2017 letter from the Acting Principal Deputy Assistant Secretary of Defense (Health Affairs), DOD has established processes and procedures to create an overall personnel management process which are documented in a draft Administrative Instruction estimated to be finalized and published by July 31, 2017.
    Recommendation: To provide decision makers with appropriate and more complete information on the continuing implementation, management, and oversight of the DHA, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to develop a plan for reassessing and revalidating personnel requirements as the missions and needs of the DHA evolve over time.

    Agency: Department of Defense
    Status: Open
    Priority recommendation

    Comments: As of April 2017, DOD has taken some steps to implement this action. According to an April 2017 letter from the Acting Principal Deputy Assistant Secretary of Defense (Health Affairs), DOD has established processes and procedures to create an overall personnel management process which are documented in a draft Administrative Instruction estimated to be finalized and published by July 31, 2017.
    Recommendation: To provide decision makers with appropriate and more complete information on the continuing implementation, management, and oversight of the DHA, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to determine the future of the Public Health and Medical Education and Training shared services by either identifying common functions to consolidate to achieve cost savings or by developing a justification for the transfer of these functions from the military services to the DHA that is not premised on cost savings.

    Agency: Department of Defense
    Status: Open
    Priority recommendation

    Comments: As of April 2017, DOD has taken some steps to implement this action. According to an April 2017 letter from the Acting Principal Deputy Assistant Secretary of Defense (Health Affairs), DOD has changed the designation of its Public Health function from a shared service to a division. This change recognizes the distinction that we previously highlighted between a shared service, or the consolidation of functions previously performed by the military services, and a transfer of functions from the military services to the DHA. The letter states that DOD is in the process of assessing business case analyses for various efficiency efforts, with one proposal estimated to save $613 million over three years. DOD has not taken similar action with regard to its Medical Education and Training shared service. As we previously reported in our prior update, while DOD cites future cost savings in its modeling and simulation and online learning product lines, we reported in 2014 that these initiatives overlap with the DHA's Contracting and Procurement and Information Technology shared services. For example, while cost savings for Modeling and Simulation are allocated to the Medical Education and Training Directorate, implementation costs are to be incurred by the Contracting and Procurement shared service. This recommendation will remain open until DOD either identifies common functions to consolidate within Medical Education and Training to achieve cost savings or develops a justification for the transfer of these functions from the military services to the DHA that is not premised on cost savings.
    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: Valerie C. Melvin
    Phone: (202) 512-6304

    4 open recommendations
    Recommendation: To facilitate oversight and inform decision making regarding their respective department's interoperability-related activities, the Secretaries of Defense and Veterans Affairs, working with the Interagency Program Office, should ensure related goals are defined to provide a basis for assessing and reporting on the status of interoperability-related activities and the extent to which interoperability is being achieved by the departments' modernized electronic health record systems.

    Agency: Department of Defense
    Status: Open

    Comments: The Department of Defense (DOD) and the Department of Veterans Affairs (VA) are working to define goals to provide a basis for assessing and reporting on the status of interoperability-related activities and the extent to which interoperability is being achieved by the departments' modernized electronic health record systems. Specifically, according to the DOD/VA Interagency Program Office (IPO), the office, in conjunction with the departments, has employed use cases in the Joint Interoperability Plan to define the interoperability-related goal areas, which are to be used as the basis for the development of outcome-oriented metrics, assessments, and reporting. The departments, the IPO, and workgroups within the Health Executive Committee's data sharing areas have focused on the feasibility and development of metrics aligned to six use cases as they relate to electronic health record interoperability between DOD and VA and outcomes to service members, veterans, and healthcare providers. The IPO reports that the work to establish these goals will be completed by December 2017. GAO will continue to review the results of these efforts.
    Recommendation: To facilitate oversight and inform decision making regarding their respective department's interoperability-related activities, the Secretaries of Defense and Veterans Affairs, working with the Interagency Program Office, should ensure related goals are defined to provide a basis for assessing and reporting on the status of interoperability-related activities and the extent to which interoperability is being achieved by the departments' modernized electronic health record systems.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: The Department of Veterans Affairs (VA) and the Department of Defense (DOD) are working to define goals to provide a basis for assessing and reporting on the status of interoperability-related activities and the extent to which interoperability is being achieved by the departments' modernized electronic health record systems. Specifically, according to the DOD/VA Interagency Program Office (IPO), the office, in conjunction with the departments, has employed use cases in the Joint Interoperability Plan to define the interoperability-related goal areas, which are to be used as the basis for the development of outcome-oriented metrics, assessments, and reporting. The departments, the IPO, and workgroups within the Health Executive Committee's data sharing areas have focused on the feasibility and development of metrics aligned to six use cases as they relate to electronic health record interoperability between VA and DOD and outcomes to service members, veterans, and healthcare providers. The IPO reports that the work to establish these goals will be completed by December 2017. GAO will continue to review the results of these efforts.
    Recommendation: To facilitate oversight and inform decision making regarding their respective department's interoperability-related activities, the Secretaries of Defense and Veterans Affairs, working with the Interagency Program Office, should update IPO guidance to reflect the metrics and goals identified.

    Agency: Department of Defense
    Status: Open

    Comments: According to the Department of Defense (DOD)/Department of Veterans Affairs (VA) Interagency Program Office (IPO), the office has issued an update to the Health Data Interoperability Management Plan that documents the IPO's role and outlines governance for supporting interoperability between the departments. The IPO is also in the process of updating additional guidance to describe the benefits of interoperability and reflect associated outcome-oriented metrics and goals. Specifically, IPO officials reported that the IPO's Joint Interoperability Plan is transitioning to the Joint Interoperability Strategic Plan and is expected to be finalized in November 2017. GAO will review this guidance once it is approved by DOD and VA.
    Recommendation: To facilitate oversight and inform decision making regarding their respective department's interoperability-related activities, the Secretaries of Defense and Veterans Affairs, working with the Interagency Program Office, should update IPO guidance to reflect the metrics and goals identified.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: According to the Department of Defense (DOD)/Department of Veterans Affairs (VA) Interagency Program Office (IPO), the office has issued an update to the Health Data Interoperability Management Plan that documents the IPO's role and outlines governance for supporting interoperability between the departments. The IPO is also in the process of updating additional guidance to describe the benefits of interoperability and reflect associated outcome-oriented metrics and goals. Specifically, IPO officials reported that the IPO's Joint Interoperability Plan is transitioning to the Joint Interoperability Strategic Plan and is expected to be finalized in November 2017. GAO will review this guidance once it is approved by VA and DOD.
    Director: James R. McTigue, Jr.,
    Phone: (202) 512-9110

    3 open recommendations
    Recommendation: To strengthen oversight of the individual shared responsibility and premium tax credit provisions, the Commissioner of Internal Revenue should assess whether or not the data received from the health insurance marketplaces are sufficiently complete and accurate to enable effective correction of tax returns at-filing based on matching with the marketplace data and, if the assessment determines that such corrections would be effective, seek legislative authority to correct tax returns at-filing based on the marketplace data.

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

    Comments: The Internal Revenue Service (IRS) agreed with GAO's recommendation. IRS reports that the quality of data submitted by health insurance marketplaces has improved since the 2015 return filing season, and it continues to use its correspondence process for resolving discrepancies between marketplace data and that reported by the taxpayer after the return has been filed. IRS has not considered requesting legislative authority to correct tax returns at the time of filing based specifically on discrepancies between the data submitted by the health insurance marketplace and reported by the taxpayer. Agency officials believe that would be premature at this time. They noted that a broader legislative initiative has already been proposed that would grant IRS with correctable error authority in cases where the information provided by the taxpayer does not match the information contained in government databases. Should this broad authority be granted in the future, IRS will then consider how to approach correction of tax returns at the time of filing based on discrepancies with health insurance marketplace data. Such authority was also included in the Administration's 2018 budget.
    Recommendation: To strengthen oversight of the individual shared responsibility and premium tax credit provisions, the Commissioner of Internal Revenue should work with CMS to get the total amount of advance PTC paid for the 2014 tax year and establish, as a baseline, the aggregate amount of the gap between advance PTC paid and advance PTC reported for the 2014 tax year, and track this aggregate gap for future tax years to help in evaluating the effectiveness of IRS's PTC education and compliance efforts.

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

    Comments: The Internal Revenue Service (IRS) agreed with GAO's recommendation in part. As one of the ongoing efforts by the IRS to evaluate the effectiveness of its implementation of the premium tax credit (PTC) provision for tax year 2014, IRS plans to perform as analysis of reporting of advance payments of the PTC by the Marketplaces. The results of this analysis and other efforts will help inform the IRS of potential areas for improvement in education, tax filing and compliance activities. IRS has been tracking the amount of advance PTC paid based on summary data provided by the Centers for Medicare & Medicaid Services (CMS) for 2014 and 2015 as well as the gap between the amounts paid compared to the amount reported by taxpayers. However, IRS has not yet resolved all issues with CMS related to properly allocating all payments to 2014 and 2015. Complete data for 2016 are not yet available.
    Recommendation: To strengthen oversight of the individual shared responsibility and premium tax credit provisions, the Commissioner of Internal Revenue should evaluate IRS efforts to collaborate and communicate with key external stakeholders to inform efforts related to implementation of the new 2015 PPACA requirements.

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

    Comments: The Internal Revenue Service (IRS) agreed with GAO's recommendation but has not yet initiated an evaluation of collaboration and communication efforts with external stakeholders. IRS currently utilizes informal feedback processes to share information and identify opportunities for improvement with external stakeholders in implementing the shared responsibility payment and premium tax credit provisions. We continue to encourage IRS to evaluate its collaboration and communication efforts.
    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: Linda Kohn
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: In order to strengthen DEA's communication with and guidance for registrants and associations representing registrants, as well as supporting the Office of Diversion Control's mission of preventing diversion while ensuring an adequate and uninterrupted supply of controlled substances for legitimate medical needs, the Deputy Assistant Administrator for the Office of Diversion Control should identify and implement means of cost-effective, regular communication with distributor, pharmacy, and practitioner registrants, such as through listservs or web-based training.

    Agency: Department of Justice: Drug Enforcement Administration: Operations Division: Office of Diversion Control: Deputy Assistant Administrator for the Office of Diversion Control
    Status: Open

    Comments: As of March 2017, DEA officials reported that the agency was taking steps towards addressing this recommendation. In particular, DEA officials reported that they were in the process of developing a method to deliver information about registrant responsibilities through DEA's registration website, which registrants could access annually when they update their registration. DEA officials also reported that they would consider a method for registrants to subscribe to get email updates when new information is posted to Diversion Control Division website. We plan to continue to monitor the agency's efforts in this area, and this recommendation remains open.
    Recommendation: In order to strengthen DEA's communication with and guidance for registrants and associations representing registrants, as well as supporting the Office of Diversion Control's mission of preventing diversion while ensuring an adequate and uninterrupted supply of controlled substances for legitimate medical needs, the Deputy Assistant Administrator for the Office of Diversion Control should solicit input from distributors, or associations representing distributors, and develop additional guidance for distributors regarding their roles and responsibilities for suspicious orders monitoring and reporting.

    Agency: Department of Justice: Drug Enforcement Administration: Operations Division: Office of Diversion Control: Deputy Assistant Administrator for the Office of Diversion Control
    Status: Open

    Comments: In March 2017, DEA officials reported that the agency had worked with its Suspicious Orders Task Force to develop a draft Suspicious Orders regulation. They reported that the draft regulation was undergoing internal DEA review, but that it was uncertain when the draft regulation would be published in the Federal Register. We plan to continue to monitor the agency's efforts in this area, and this recommendation remains open.
    Recommendation: In order to strengthen DEA's communication with and guidance for registrants and associations representing registrants, as well as supporting the Office of Diversion Control's mission of preventing diversion while ensuring an adequate and uninterrupted supply of controlled substances for legitimate medical needs, the Deputy Assistant Administrator for the Office of Diversion Control should solicit input from pharmacists, or associations representing pharmacies and pharmacists, about updates and additions needed to existing guidance for pharmacists, and revise or issue guidance accordingly.

    Agency: Department of Justice: Drug Enforcement Administration: Operations Division: Office of Diversion Control: Deputy Assistant Administrator for the Office of Diversion Control
    Status: Open

    Comments: In April 2016, DEA reported that it had worked with the National Association of Boards of Pharmacy regarding issues raised during stakeholder discussions, which resulted in a March 2015 consensus document published by stakeholders entitled "Stakeholders' Challenges and Red Flag Warning Signs Related to Prescribing and Dispensing Controlled Substances." Additionally, in December 2016 DEA also described other ways in which the agency had been working with pharmacists or associations representing pharmacists to discuss their responsibilities, such as during regional one-day Pharmacy Diversion Awareness Conferences, and quarterly meetings with two pharmacy associations. In March 2017, DEA officials reported that while an update to the Pharmacist's Manual was still under way, they did not have an estimated completion date. We plan to continue to monitor the agency's efforts in this area, as well, and consequently this recommendation remains open.
    Director: James Cosgrove
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To help ensure the financial sustainability of the Medicare program, protect beneficiaries from unwarranted financial burden, and address potential concerns about the appropriateness of the health care provided to Part B beneficiaries, Congress should consider eliminating the incentive to prescribe more drugs or more expensive drugs than necessary to treat Medicare Part B beneficiaries at 340B hospitals.

    Agency: Congress
    Status: Open

    Comments: As of February 2017, no action had been taken on this Matter for Congressional Consideration.
    Director: Debra A. Draper
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: To eliminate the fragmentation and duplication in the storage of unclassified OEHS data, the Secretary of Defense should determine which IT system--DOEHRS or MESL--should be used to store specific types of unclassified OEHS data, clarify the department's policy accordingly, and require all other departmental and military-service-specific policies to be likewise amended and implemented to ensure consistency.

    Agency: Department of Defense
    Status: Open

    Comments: In November 2016, officials told us that draft versions of the revised DoDI 6490.03, Deployment Health, and the new Defense Health Agency Procedural Instruction (DHA PI) 6490.03, Deployment Health, are still under review with DOD components. These revised and updated documents will address the recommendation on OEHS data storage. Additionally, DoDI 6055.05, Occupational and Environmental Health (OEH), and Military Service and Combatant Command policy and guidance documents are still being revised to be consistent with DoDI 6490.03 and DHA PI 6490.03 after they are published. These revisions will ensure the consistency among policies. As of November 2016, the entire process is expected to be complete within 10 to 14 months.
    Recommendation: To ensure the reliability of OEHS data, the Secretary of Defense should establish clear policies and procedures for performing quality assurance reviews of the OEHS data collected during deployment, to include verifying the completeness and the reasonableness of these data, and require that all other related military-service-specific policies be amended and implemented to ensure consistency.

    Agency: Department of Defense
    Status: Open

    Comments: In August 2016, officials told us that draft versions of the revised DoDI 6490.03, Deployment Health, and the new Defense Health Agency Procedural Instruction (DHA PI) 6490.03, Deployment Health, are in review among the DOD Components. Further, DoDI 6055.05, Occupational and Environmental Health (OEH) and Military Service and Combatant Command policy and guidance documents will be revised to be consistent with DoDI 6490.03 and DHA PI 6490.03 after they are published. In addition, DOD is exploring improvement to the data quality assurance functionality within the Defense Occupational and Environmental Health Readiness System Industrial Hygiene (DOEHRS-IH). A new DOEHRS-IH version (2.0.18.1) was released on August 19, 2016 that contained several system enhancements and defect corrections to improve overall data quality in the system. DOD anticipates additional releases in FY 2017 that will further improve DOEHRS-IH data quality. The revised policies and the new DOEHRS-IH functionality will appropriately address the recommendation on quality assurance of OEHS data.
    Recommendation: To ensure that potential occupational and environmental health risks are mitigated for servicemembers deployed to Iraq and Afghanistan, the Secretary of Defense should require CENTCOM to revise its policy to ensure that base commanders' decisions on whether to implement risk mitigation recommendations identified in OEHSAs are adequately documented and consistently monitored by the appropriate command.

    Agency: Department of Defense
    Status: Open

    Comments: In August 2016, officials told us that the current DoDI 6055.01, DoD Safety and Occupational Health Program, requires DoD components to establish procedures that document, archive, and reevaluate risk management decisions on a recurring basis. Draft versions of the revised DoDI 6490.03, Deployment Health, and the new Defense Health Agency Procedural Instruction (DHA PI) 6490.03, Deployment Health, include language that is consistent with DoDI 6055.01. Additionally, U.S. Central Command Regulation 40-2 (CCR 40-2), which was updated as of March 8, 2016, references the requirement to establish procedures to assure risk management decisions are documented, archived, and reevaluated on a recurring basis. The DOD is also exploring a risk management decision and monitoring functionality in DOEHRS-IH. It has identified and approved the necessary system change requests required to improve risk management decisions and monitoring functionality. These functionalities are primarily focused around the Occupational & Environmental Health Site Assessment (OEHSA) and associated exposure pathways, sampling plans, and assessments. Subject to the availability of FY 2017 funding, DOD will implement the system change requests, and achieve the required enhancements to DOEHRS-IH. These policies once published and the new DOEHRS-IH functionality will appropriately address the recommendation on documenting and monitoring risk management decisions.
    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: 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: Susan Fleming,
    Phone: (202) 512-2834

    1 open recommendations
    Recommendation: The Secretary of Transportation should direct the Administrator of NHTSA to identify actions--in addition to the agency's currently planned efforts--to support state efforts to increase public awareness of the dangers of drug-impaired driving. This effort should be undertaken in consultation with ONDCP, HHS, state highway-safety offices, and other interested parties as needed.

    Agency: Department of Transportation
    Status: Open

    Comments: NHTSA met with ONDCP, HHS, and GHSA in March 2016 and discussed what consumer research has been done and education materials have been used in raising awareness for the drug-impaired driving issue. NHTSA completed marijuana creative concept focus group market research in the Fall of 2016; however, the findings from this research were inconclusive. NHTSA plans to determine next steps and develop a new strategy in communicating on this challenging topic by Spring 2017. NHTSA anticipates conducting additional market research that will provide the direction for the development of creative materials by Fall 2017.
    Director: James Cosgrove
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To help the Department of Health and Human Services better control spending and encourage efficient delivery of care, Congress should consider requiring Medicare to pay PCHs as it pays PPS teaching hospitals, or provide the Secretary with the authority to otherwise modify how Medicare pays PCHs. To generate cost savings from any reduction in outpatient payments to PCHs, Congress should also provide that all forgone outpatient payment adjustment amounts be returned to the Supplementary Medical Insurance Trust Fund.

    Agency: Congress
    Status: Open

    Comments: The 21st Century Cures Act enacted in December 2016 slightly reduces the additional payments to PCHs for outpatient services furnished on or after January 1, 2018, and returns savings to the Supplementary Medical Insurance Trust Fund. However, the law does not substantively change how PCHs are paid for outpatient services, which differs from how Medicare pays PPS teaching hospitals. In addition, as of March 1, 2017, no legislative action had been identified that changes how PCHs are paid for inpatient services, as GAO suggested in February 2015. Until Medicare pays these cancer hospitals in a way that encourages greater efficiency, Medicare remains at risk for overspending.
    Director: Vijay D'Souza
    Phone: (202) 512-7114

    2 open recommendations
    including 2 priority recommendations
    Recommendation: To better assess and address the full extent of improper payments in the TRICARE program, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to implement a more comprehensive TRICARE improper payment measurement methodology that includes medical record reviews, as done in other parts of its existing postpayment claims review programs.

    Agency: Department of Defense
    Status: Open
    Priority recommendation

    Comments: The Department of Defense's Defense Health Agency (DHA) has taken some action to incorporate medical record reviews in its improper payment estimate, as GAO recommended in February 2015. In October 2016, DHA released a request for proposals for claim record reviews, including medical record reviews, that the agency plans to use to support the agency's requirement to identify and report on the potential of improper payments to the Office of Management and Budget. This is a good first step. Once DHA incorporates medical record reviews in its improper payment rate calculation methodology, GAO will be able to close this recommendation.
    Recommendation: To better assess and address the full extent of improper payments in the TRICARE program, and once a more comprehensive improper payment methodology is implemented, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to develop more robust corrective action plans that address underlying causes of improper payments, as determined by the medical record reviews.

    Agency: Department of Defense
    Status: Open
    Priority recommendation

    Comments: Until the department implements a more comprehensive TRICARE improper payment measurement methodology and identifies the underlying causes of improper payments, the full extent of improper payments in the TRICARE program will likely not be identified and addressed. As of October 2016, the Department of Defense's Defense Health Agency has not yet implemented a more comprehensive TRICARE improper payment measurement methodology, and has, therefore, not developed more robust corrective action plans.
    Director: Randall B. Williamson
    Phone: (202) 512-7114

    6 open recommendations
    Recommendation: To improve identification of enlisted servicemembers separated for non-disability mental conditions, and to provide reasonable assurance that enlisted servicemembers, including Air Force National Guard members, are separated for non-disability mental conditions as appropriate and in accordance with DOD requirements, the Secretary of Defense should direct the Under Secretary of Defense for Personnel and Readiness and the Secretaries of the Army and the Navy and the Commandant of the Marine Corps to use the separation codes specific to a non-disability mental condition or develop another uniform method to track servicemembers who have been separated for specific non-disability mental conditions so that this information can be easily retrieved.

    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 improve identification of enlisted servicemembers separated for non-disability mental conditions, and to provide reasonable assurance that enlisted servicemembers, including Air Force National Guard members, are separated for non-disability mental conditions as appropriate and in accordance with DOD requirements, the Secretary of Defense should direct the Under Secretary of Defense for Personnel and Readiness and the Secretary of the Air Force to take steps to ensure there is an appropriately staffed process to identify and administratively separate enlisted National Guard members who are unable to function effectively in the National Guard because of a non-disability mental condition.

    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 improve identification of enlisted servicemembers separated for non-disability mental conditions, and to provide reasonable assurance that enlisted servicemembers, including Air Force National Guard members, are separated for non-disability mental conditions as appropriate and in accordance with DOD requirements, the Secretary of Defense should direct the Secretaries of the Army, the Air Force, and the Navy and the Commandant of the Marine Corps to update their services' administrative separation policies to be consistent with DOD regulations for those servicemembers separated for all non-disability mental conditions.

    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 improve identification of enlisted servicemembers separated for non-disability mental conditions, and to provide reasonable assurance that enlisted servicemembers, including Air Force National Guard members, are separated for non-disability mental conditions as appropriate and in accordance with DOD requirements, the Secretary of Defense should direct the Secretaries of the Air Force and the Navy and the Commandant of the Marine Corps to implement processes to oversee separations for non-disability mental conditions, such as reinstituting the requirement of annual compliance reporting of a sample of administrative separations, using current DOD policy requirements as review criteria for servicemembers of all military services and their Reserve components.

    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 improve identification of enlisted servicemembers separated for non-disability mental conditions, and to provide reasonable assurance that enlisted servicemembers, including Air Force National Guard members, are separated for non-disability mental conditions as appropriate and in accordance with DOD requirements, the Secretary of Defense should direct the Secretary of the Army to ensure that Army's planned oversight of separations for non-disability mental conditions is implemented and incorporates reservists and National Guard members separated for such conditions, or that Army implement another process to oversee such administrative separations using current DOD policy requirements as review criteria for all servicemembers, including reservists and National Guard members.

    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 improve identification of enlisted servicemembers separated for non-disability mental conditions, and to provide reasonable assurance that enlisted servicemembers, including Air Force National Guard members, are separated for non-disability mental conditions as appropriate and in accordance with DOD requirements, the Secretary of Defense should direct the Under Secretary of Defense for Personnel and Readiness to review any processes used by the military services to oversee such administrative separations to ensure compliance with DOD requirements.

    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: Vijay A. D'Souza
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: In order to ensure that efforts to address prenatal opioid use and NAS are systematically and effectively planned and coordinated across the federal government, the Director of ONDCP should document the process, including discussions held and information considered, of developing action items on prenatal opioid use and NAS. This may include documenting gaps that were considered in developing action items.

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

    Comments: In May 2017 and July 2017, ONDCP officials described the process used to develop the action items related to prenatal opioid use and NAS for the 2015 National Drug Control Strategy report. Specifically, officials described working directly with federal agencies to identify proposals for action items and review proposals during an interagency working group meeting in March 2015. However, ONDCP officials could not provide us any formal documentation, such as meeting minutes, showing the process used or what gaps were considered in developing the action items. ONDCP officials also told us the action items related to prenatal opioid use and NAS for the 2015 Strategy have been generally completed. No action items related to prenatal opioid use and NAS were included in the 2016 Strategy and ONDCP officials said they did not know whether any related action items will be included for the 2017 Strategy. We will update the status of this recommendation after future Strategy reports are published.
    Director: Marcia Crosse
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: To ensure that DEA is best positioned to administer the quota process to ensure an adequate and uninterrupted supply of controlled substances for legitimate medical use and respond to shortages of drugs containing controlled substances, the Administrator of DEA should expeditiously establish formal policies and procedures to facilitate coordination with FDA as directed by the Food and Drug Administration Safety and Innovation Act, including a specific time frame in which DEA will be expected to respond to FDA requests to expedite shortage-related quota applications.

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

    Comments: In June 2016, DEA stated that the agency had met with FDA to determine the specific procedures by which information regarding drug shortages will be exchanged pursuant to the Food and Drug Administration Safety and Innovation Act. DEA stated it will include these procedures in the work plan being created in response to the updated memorandum of understanding signed by FDA and DEA in March 2015. DEA officials also said that they plan to include in the work plan time frames for which DEA will be expected to respond to FDA requests to expedite shortage-related quota applications. GAO is continuing to monitor the status of this recommendation.
    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.
    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 Justice: Drug Enforcement 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. 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: Randall B. Williamson
    Phone: (202) 512-7114

    4 open recommendations
    Recommendation: To ensure DHA can accurately and consistently assess mental health provider staffing needs across each of the military services, the Secretary of Defense should direct the Secretaries of the Army, Air Force, and Navy to require the medical commands of each military service to include its estimated mental health provider staffing needs generated through PHRAMS in the requirements fields of DHA's quarterly mental health staffing reports.

    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: The Secretary of Defense should direct the Assistant Secretary of Defense for Health Affairs to ensure DHA, through the PHRAMS contractor, continue to refine PHRAMS to incorporate the needs of the military services to reduce the need for additional service-specific methods of determining mental health provider staffing needs.

    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 the Defense Health Agency (DHA) can accurately and consistently assess mental health provider staffing needs across each of the military services, the Secretary of Defense should direct the Secretaries of the Army, Air Force, and Navy to require the medical commands of each military service to report any additional service-specific methods they use to determine their final estimates of mental health provider staffing needs.

    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: The Secretary of Defense should direct the Assistant Secretary of Defense for Health Affairs to require the National Capital Region Medical Directorate to include its estimated mental health provider staffing needs generated through PHRAMS in the requirements fields of DHA's quarterly mental health staffing reports.

    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: 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

    2 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 Defense
    Status: Open

    Comments: The Department of Defense's position is that it already engages in periodic program evaluation of its psychological health programs as required. It noted that on November 24, 2014, the Under Secretary of Defense for Personnel and Readiness directed the Military Departments and other Department of Defense components to assist in an initiative to evaluate Psychological Health and Traumatic Brain Injury programs across the Department of Defense. As of September 2017, we have not received a further update on the Department of Defense's actions. We will continue to monitor these efforts and seek to determine whether they result in documentation of which programs should be evaluated and how such evaluations should be completed.
    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: Daniel Bertoni
    Phone: (202) 512-7215

    3 open recommendations
    including 1 priority recommendation
    Recommendation: To improve the ability of the agency to detect and prevent potential physician-assisted fraud, and to address potential disincentives for staff to detect and prevent physician-assisted fraud, SSA should review the standards used to assess DDS performance; and develop and distribute promising practices to incentivize staff to better balance the goal of processing claims promptly with the equally important goal of identifying and reporting evidence of potential fraud.

    Agency: Social Security Administration
    Status: Open

    Comments: SSA partially agreed with this recommendation, citing that their employees take their stewardship responsibilities seriously and that field office and disability determination services (DDS) employees are the agency's first and best line of defense against fraud. In 2016, the agency reported that it was working with experts in its OIG and Office of Anti-Fraud Programs to develop and disseminate promising practices on identifying and reporting fraud. We will close this recommendation once SSA takes steps to review its standards for assessing DDS performance and disseminates the best practices it is developing.
    Recommendation: To improve the ability of the agency to detect and prevent potential physician-assisted fraud, and to address the potential risks associated with medical evidence submitted by sanctioned physicians, SSA should evaluate the threat posed by this information and, if warranted, consider changes to its policies and procedures.

    Agency: Social Security Administration
    Status: Open

    Comments: As of 2016, SSA reported that it was pursuing several options to address the potential risks of medical evidence submitted by sanctioned physicians. This included determining how it could use licensure information from the List of Excluded Individuals and Entities. SSA stated that it believes the best opportunity to further evaluate the possible review of the license statuses of medical evidence providers is in conjunction with the implementation of the National Vendor File, part of the national Disability Case Processing System, which is under development. In addition, SSA reported it had drafted two Social Security Rulings to define fraud and to provide processes for disregarding evidence and making redeterminations in disability claims when there is reason to believe that fraudulent evidence was provided. We will close this recommendation once SSA articulates a strategy for using license status information in the vendor file and it finalizes its rulings.
    Recommendation: To improve the ability of the agency to detect and prevent potential physician-assisted fraud, and to help ensure new initiatives that use analytics to identify potential fraud schemes are successful, SSA should develop an implementation plan that identifies both short- and long-term actions, including: (1) timeframes for implementation; (2) resources and staffing needs; (3) data requirements, e.g., the collection of unique medical provider information; (4) how technology improvement will be integrated into existing technology improvements such as the Disability Case Processing System and National Vendor File; and (5) how different initiatives will interact and support each other.

    Agency: Social Security Administration
    Status: Open
    Priority recommendation

    Comments: Since fiscal year 2015, SSA has taken several steps that will help the agency to combat fraud, waste, and abuse. SSA established the Office of Anti-Fraud Programs to provide centralized oversight and accountability for the agency's initiatives, which, in consultation with the Office of the Inspector General and other SSA components, will lead the development of SSA's anti-fraud initiatives and activities. This includes efforts to mitigate fraud through data analytics that utilize SSA's existing data systems. SSA developed a strategic plan for fiscal years 2016-2018 to guide its anti-fraud efforts that includes the use of data analytics. However, this plan does not specifically address actions to combat potential physician-assisted fraud. As of April 2017, SSA stated that it continued to develop a fraud management strategy that is consistent with the leading practices identified in GAO's report. Once the strategy is complete, SSA plans to conduct a fraud risk assessment on its major lines of business, beginning with the disability program in fiscal year 2017. We will continue to monitor SSA's progress to identify and prevent fraud schemes that include physicians.
    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: Debra A. Draper
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To help ensure adequate and qualified nurse staffing at VAMCs, the Secretary of Veterans Affairs should direct the Interim Under Secretary for Health to enhance VHA's internal controls by completing evaluations of Phase I and Phase II and make any necessary changes to policies and procedures before national implementation of Phase II in all VAMCs.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VA agreed with this recommendation and, according to an update received April 2017, VA is taking actions towards addressing this recommendation and expects to complete those actions Fall 2017. When additional information is received GAO will update the recommendation as appropriate.
    Director: J. Alfredo Gómez
    Phone: (202) 512-3841

    1 open recommendations
    Recommendation: To help ensure that FSIS efforts protect human health by reducing Salmonella and Campylobacter contamination in FSIS-regulated poultry products, in future revisions of the compliance guidelines on controlling Salmonella and Campylobacter, the Secretary of Agriculture should direct the Administrator of FSIS to ensure the inclusion of information on the effectiveness of each recommended farm practice to reduce these pathogens in live poultry.

    Agency: Department of Agriculture
    Status: Open

    Comments: In December 2015, USDA's Food Safety and Inspection Service released the draft revised compliance guideline to assist poultry establishments in controlling Salmonella and Campylobacter in raw poultry. The draft guideline included information on the effectiveness of each recommended farm practice to reduce Salmonella and Campylobacter in live poultry. FSIS announced the availability of and requested comment on the revised compliance guideline in a December 2015 Federal Register Notice. FSIS officials told us that they anticipate finalizing the draft guideline in fiscal year 2017 and the guideline states that while the document is draft, establishments are encouraged to incorporate information in the guideline in their decision-making process. As of April 2017, FSIS had not finalized the guideline.
    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: Randall B. Williamson
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: To ensure that the Family Caregiver Program is able to meet caregivers' demand for its services, the Secretary of the Department of Veterans Affairs should expedite the process for identifying and implementing an IT system that fully supports the program and will enable VHA program officials to comprehensively monitor the program's workload, including data on the status of applications, appeals, home visits, and the use of other support services, such as respite care.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VA concurred with our recommendation and stated that its efforts to develop and implement a new IT system has two key steps. First, VA will enhance and stabilize the existing Caregiver Action Tracker IT system. Second, a replacement IT system with new features and capabilities will be implemented by the end of FY 2017. However, in January 2017, VA reported that the short-term stabilization effort for the current IT system continues to experience multiple challenges resulting in significant schedule delays. Furthermore, the replacement IT system--which is partially dependent on the success of the current stabilization effort--has experienced project barriers of its own, and lacks the funding needed for a contract extension to complete the work. According to VA, the successful implementation of the replacement IT system is at significant risk.
    Recommendation: The Secretary of the Department of Veterans Affairs should direct the Undersecretary for Health to use data from the IT system, once implemented, as well as other relevant data to formally reassess how key aspects of the program are structured and to identify and implement modifications as needed to ensure that the program is functioning as envisioned so that caregivers can receive the services they need in a timely manner.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VA concurred with this recommendation; however, in January 2017, VA reported that barriers continue to place the replacement IT system at significant risk as stated in Recommendation 1. In advance of the electronic solution, VA has developed manual processes to obtain and monitor key data points, allowing it to reassess policies and procedures for the Program of Comprehensive Assistance for Family Caregivers. In its June 2015 update, VA stated that the Caregiver Support Program had started collaborating with VA's Health Services Research and Development to establish a Partnered Evaluation Center (PEC). The PEC is assessing the impact of all caregiver support services in order to evaluate their effectiveness and impact on the health and well-being of veterans and caregivers. In January 2017, VA reported that the PEC's initial work had concluded and key findings had been identified.
    Director: Brenda S. Farrell
    Phone: (202) 512-3604

    2 open recommendations
    Recommendation: To help ensure that DOD has the necessary information to determine the extent to which cost savings result from any future consolidation of training within METC or the Education and Training Directorate, the Assistant Secretary of Defense for Health Affairs should direct the Director of the DHA to develop baseline cost information as part of its metrics to assess achievement of cost savings.

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

    Comments: The House Report Accompanying the National Defense Authorization Act for Fiscal Year 2015, citing our work on this subject, required DOD to submit a report by January 31, 2015 detailing, among other things, an explanation of the purpose and goals of the medical education and training shared service with regard to its role in improving the cost efficiency of delivering training, including the challenges it will address, the practices it will put in place to address these challenges, and the resulting cost savings. However, as of September 2015, DOD has not submitted this report. Until DOD develops baseline cost information as part of its metrics to assess achievement of cost savings, this recommendation should remain open.
    Recommendation: To help realize the reform effort's goal of achieving cost savings, the Assistant Secretary of Defense for Health Affairs should direct the Director of the DHA to conduct a fully developed business case analysis for the Education and Training Directorate's reform effort. In this analysis the Director should (1) identify the cost-related problem that it seeks to address by establishing the Education and Training Directorate, (2) explain how the processes it has identified will address the costrelated problem, and (3) conduct and document an analysis of benefits, costs, and risks.

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

    Comments: The House Report Accompanying the National Defense Authorization Act for Fiscal Year 2015, citing our work on this subject, required DOD to submit a report by January 31, 2015 detailing, among other things, an explanation of the purpose and goals of the medical education and training shared service with regard to its role in improving the cost efficiency of delivering training, including the challenges it will address, the practices it will put in place to address these challenges, and the resulting cost savings. However, as of September 2015, DOD has not submitted this report. We reported in September 2015 that DOD has not yet presented a fully developed business case for its Medical Education and Training shared service. Until DOD addresses these concerns, this recommendation should remain open.
    Director: Debra A. Draper
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To eliminate unnecessary program duplication and to achieve increased efficiencies and potential savings within the integrated MHS, Congress should terminate the Secretary of Defense's authority to contract with the USFHP designated providers in a manner consistent with a reasonable transition of affected USFHP enrollees into TRICARE's regional managed care program or other health care programs, as appropriate.

    Agency: Congress
    Status: Open

    Comments: As of April 2017, no actions have been taken.
    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: Joseph Kirschbaum
    Phone: (202) 512-9971

    1 open recommendations
    Recommendation: To help ensure that DOD's investments are being applied toward developing medical countermeasures to respond to the most serious and likely biological threat agents, the Secretary of Defense should direct the appropriate DOD officials to develop and implement a process to update and validate DOD's list of biological threats, as required by DOD Directives 5160.05E and 6205.3, or implement a process that aligns with the department's current policies, practices, and priorities as reflected in the 2001 and 2010 Quadrennial Defense Reviews .

    Agency: Department of Defense
    Status: Open

    Comments: DOD concurred with the recommendation. DOD has been reviewing directives addressing biological warfare threats and is in the process of revising DOD Directive 5160.05E to ensure that the directive appropriately captures and institutionalizes the use of risk assessments to support research, development, and acquisition of chemical and biological defense capabilities. The Chemical and Biological Defense Program (CBDP) piloted the risk assessment process in 2014 and will continue to conduct annual risk assessments to support portfolio planning and guidance. In addition to this revision, the CBDP continues to improve stakeholder awareness and discussions on threats through the utilization of an annual threat day review and on-going Joint Service discussions on chemical and biological threats and capabilities to address those threats. Alignment of the threat information and medical countermeasure capabilities are discussed through the CBDP Medical Prime/Non-Prime Working Group, which was established in February 2015 to ensure the CBDP medical portfolio is addressing the highest priority threats considering available candidates and resources. The group meets quarterly to address key programmatic changes, discuss program strategic guidance, and to address information presented and discussed at the annual threat review sessions. In total, these efforts have improved the Department's ability to ensure biological threats are aligned and considered through holistic, threat-informed, risk-based assessments. DOD is also taking actions to improve the development of medical countermeasures against priority threats through a number of actions such as developing a process guide, holding threat days, and performing in-depth analyses on medical science and technology solutions. Once DOD completes and issues Directive 5160.05E, we will assess the extent to which DOD's combined actions address the recommendation.
    Director: J. Alfredo Gómez
    Phone: (202) 512-3841

    3 open recommendations
    Recommendation: To develop an estimate of the scope of work remaining to address uranium contamination on or near the Navajo reservation, Congress should consider requiring that the Environmental Protection Agency take the lead and work with the other federal agencies to develop an overall estimate of the remaining scope of the work, time frames, and costs.

    Agency: Congress
    Status: Open

    Comments: As of December 2016, we are not aware of any legislation being enacted to address this matter for congressional consideration.
    Recommendation: In light of the problems BIA has encountered in managing the cleanup at the Tuba City Dump site, the Secretary of the Interior should direct the Assistant Secretary for Indian Affairs to employ best practices in creating the schedule and cost estimates for the remedial action cleanup phase.

    Agency: Department of the Interior
    Status: Open

    Comments: As of December 2016, GAO is awaiting action by the agency to implement this recommendation.
    Recommendation: In light of the problems BIA has encountered in managing the cleanup at the Tuba City Dump site, the Secretary of the Interior should direct the Assistant Secretary for Indian Affairs to identify and examine any lessons learned from managing the remedial investigation and feasibility study contract and consider these lessons as part of the acquisition planning process for the remedial action contract.

    Agency: Department of the Interior
    Status: Open

    Comments: As of December 2016, GAO is awaiting action by the agency to implement this recommendation.
    Director: St James, Lorelei
    Phone: (202) 512-2834

    1 open recommendations
    Recommendation: To improve the management of VA's leased outpatient-clinic projects, the Secretary of Veterans Affairs should update VHA's guidance for leasing outpatient clinics to better reflect the roles and responsibilities of all VA staff involved in leasing projects.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: On March 30, 2017, the Executive Director, Office of Construction and Facilities management told GAO that VA intends to issue an updated Leasing Manual by the end of fiscal year 2017. GAO plans to close this recommendation when the new manual is issued.
    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: Debra Draper
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: The Secretary of Defense should require the Director of the Defense Health Agency to enhance existing guidance for the TROs to include more specificity on assessing nonenrolled beneficiaries' access to care. Specifically, the guidance should contain criteria for analyzing and interpreting the nonenrolled beneficiary and civilian provider surveys' results and the beneficiary population sizing model to facilitate a more rigorous and consistent approach across regions for identifying locations with potential access problems and determining whether actions should be taken.

    Agency: Department of Defense
    Status: Open

    Comments: In April 2016, DHA informed us that it has taken action to ensure a consistent approach across the regions for identifying locations with potential access problems and determining whether actions should be taken. Specifically, the TROs agreed in April 2014 to utilize the congressionally directed Survey of Civilian Provider Acceptance of, and Beneficiary Access to TRICARE Standard and Extra survey results as the source to identify areas of low awareness, acceptance and access scores. Once an area has been confirmed as an area of low awareness, acceptance and access, the SME will work with the respective managed care support contractor to develop an improvement action plan. In addition, to standardize analysis and provide for more specificity, in May 2014 the three TROs agreed upon a standardized Beneficiary Population Sizing Model (BPSM), an analytical tool to monitor access to care and beneficiary satisfaction for Standard beneficiaries outside PSAs. The standardized BPSM was implemented in the last TRO TRICARE Standard annual brief to the DHA Deputy Director in January 2016. DHA has noted that they took these actions as a result of our recommendation. Although they have taken these actions, we are awaiting further information regarding whether they enhanced existing guidance for the TROs to include this additional specificity on assessing nonenrolled beneficiaries' access to care. We will update this recommendation once we obtain additional information from DHA.
    Director: Dillingham, Gerald L
    Phone: (202) 512-2834

    1 open recommendations
    Recommendation: To improve the applicants' understanding of the medical standards and the information required to complete FAA's medical certification process, the Secretary of Transportation should direct the Administrator of FAA to enhance the online medical-application system by clarifying instructions and questions on the medical application form and providing useful information to applicants.

    Agency: Department of Transportation
    Status: Open

    Comments: When we confirm what actions FAA has taken in response to this recommendation, we will provide updated information.
    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: Randall Williamson
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To improve VA's ability to address its strategic plan objective of educating and empowering veterans, the Secretary of Veterans Affairs should direct the Under Secretary for Health to take steps to better understand gaps in veterans' knowledge regarding eligibility for Millennium Act emergency care, such as by conducting veteran surveys of health care benefits knowledge, and using information from those surveys to more effectively tailor the agency's education efforts regarding the Millennium Act benefit. In conducting these surveys, consideration should be given to including a sample of veterans who have had denied Millennium Act claims in order to provide their views and specific details of their experiences.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: As of September 2016, VA has taken some actions to address this recommendation, but additional actions are needed to fully implement it. We will update the status of this recommendation when we receive additional information from VA.
    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: 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: 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: Draper, Debra A
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: To provide decision makers with more complete information on the continued appropriateness of the current pharmacy services contract structure, and to ensure the best value and services to the government and beneficiaries, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to conduct an evaluation of the potential costs and benefits of alternative contract structures for the TRICARE pharmacy services contract.

    Agency: Department of Defense
    Status: Open

    Comments: The current TRICARE pharmacy services contract began in May 2015, with 1 base year and 7 option years. DOD officials stated that they intend to conduct an evaluation of the potential costs and benefits of alternative contract structures as they undergo the next acquisition cycle. GAO will continue to follow up on these recommendations as DOD begins its acquisition planning efforts for the next cycle.
    Recommendation: To provide decision makers with more complete information on the continued appropriateness of the current pharmacy services contract structure, and to ensure the best value and services to the government and beneficiaries, the Secretary of Defense should direct the Assistant Secretary of Defense (Health Affairs) to incorporate such an evaluation into acquisition planning.

    Agency: Department of Defense
    Status: Open

    Comments: DOD officials stated that they intend to include such an evaluation in their acquisition planning for the next acquisition cycle. GAO will continue to follow up on these recommendations as DOD begins its acquisition planning efforts for the next cycle.
    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: 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

    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: 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: Williamson, Randall B
    Phone: (202) 512-7114

    3 open recommendations
    including 1 priority recommendation
    Recommendation: To effectively manage fee basis care spending, the Secretary of Veterans Affairs should revise the beneficiary travel eligibility regulations to allow for the reimbursement of travel expenses for veterans to another VAMC to receive needed medical care when it is more cost-effective and appropriate for the veteran than seeking similar care from a fee basis provider.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: As of September 2015, VA has taken some actions to address this recommendation, but additional actions are needed to fully implement it. We will update the status of this recommendation when we receive additional information from VA.
    Recommendation: To effectively manage fee basis care wait times and spending, the Secretary of Veterans Affairs should direct the Under Secretary for Health to analyze the amount of time veterans wait to see fee basis providers and apply the same wait time goals to fee basis care that are used as VAMC-based wait time performance measures.

    Agency: Department of Veterans Affairs
    Status: Open
    Priority recommendation

    Comments: In October 2014, VHA established a new wait-time goal, which is that veterans should be seen within 30 days of the date that an appointment is deemed clinically appropriate by a VA health care provider, or if no such clinical determination has been made, the date a veteran prefers to be seen for hospital care or medical services. While VHA has been monitoring the timeliness of VHA-based care according to this standard, it has not been applying the same standard to community-based care, including care delivered through the Veterans Choice Program. Therefore, VHA cannot determine whether veterans are receiving care in the community sooner or later than they otherwise would receive care at VA medical facilities. To fully implement this recommendation, VHA needs to take steps to ensure that its wait-time policies and procedures for both VHA-based care and community-based care (fee basis care) are aligned.
    Recommendation: To ensure that VA Central Office effectively monitors fee basis care, the Secretary of Veterans Affairs should direct the Under Secretary for Health to ensure that fee basis data include a claim number that will allow for VA Central Office to analyze the episode of care costs for fee basis care.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: As of September 2015, VA has taken some actions to address this recommendation, but additional actions are needed to fully implement it. We will update the status of this recommendation when we receive additional information from VA.
    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: 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) 512-7114

    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: Draper, Debra A
    Phone: (202) 512-7114

    4 open recommendations
    including 2 priority recommendations
    Recommendation: To ensure reliable measurement of veterans' wait times for medical appointments, the Secretary of VA should direct the Under Secretary for Health to take actions to improve the reliability of wait time measures either by clarifying the scheduling policy to better define the desired date, or by identifying clearer wait time measures that are not subject to interpretation and prone to scheduler error.

    Agency: Department of Veterans Affairs
    Status: Open
    Priority recommendation

    Comments: VA concurred with our recommendations to revise its scheduling policy to implement more reliable wait time measures and require all schedulers to complete standardized training on a revised scheduling policy. In July 2016, VA published VHA Directive 1230-Outpatient Scheduling Processes and Procedures, which updated and replaced the prior policy. Although the updated directive provides new instructions for scheduling appointments, the new instructions, which form the basis for measuring wait times, are still subject to scheduler interpretation, making training vital to consistent and accurate implementation of the policy. According to VHA, Directive 1230 was developed to correspond with a technical enhancement to the scheduling system, known as the Vista Scheduling Enhancement (VSE), which will also require training. As of November 2016, VHA reported that the majority of staff with scheduling access had been trained on the new directive and that separate training on VSE was scheduled to begin in February 2017. GAO cannot assess whether VHA scheduling staff are accurately implementing the new scheduling policy until the VSE roll-out is complete and all relevant staff are trained on the new system.
    Recommendation: To better facilitate timely medical appointment scheduling and improve the efficiency and oversight of the scheduling process,the Secretary of VA should direct the Under Secretary for Health to take actions to ensure that VAMCs consistently and accurately implement VHA's scheduling policy, including use of the electronic wait list, as well as ensuring that all staff with access to the VistA scheduling system complete the required training.

    Agency: Department of Veterans Affairs
    Status: Open
    Priority recommendation

    Comments: VA concurred with our recommendations to revise its scheduling policy to implement more reliable wait time measures and require all schedulers to complete standardized training on a revised scheduling policy. In July 2016, VA published VHA Directive 1230-Outpatient Scheduling Processes and Procedures, which updated and replaced the prior policy. Although the updated directive provides new instructions for scheduling appointments, the new instructions, which form the basis for measuring wait times, are still subject to scheduler interpretation, making training vital to consistent and accurate implementation of the policy. According to VHA, Directive 1230 was developed to correspond with a technical enhancement to the scheduling system,known as the Vista Scheduling Enhancement (VSE), which will also require training. As of November 2016, VHA reported that the majority of staff with scheduling access had been trained on the new directive and that separate training on VSE was scheduled to begin in February 2017. GAO cannot assess whether VHA scheduling staff are accurately implementing the new scheduling policy until the VSE roll-out is complete and all relevant staff are trained on the new system.
    Recommendation: To improve timely medical appointment scheduling, the Secretary of VA should direct the Under Secretary for Health to develop a policy that requires VAMCs to routinely assess clinics' scheduling needs and resources to ensure that the allocation of staffing resources is responsive to the demand for scheduling medical appointments.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VA concurred with this recommendation and noted that it would ask VA facilities to routinely assess clinics' availability and ensure staff are distributed to meet access standards for clinics, as well as revising and implementing improved clinic management tools. In February 2015, VHA noted that it had finalized a Scheduling Resource Assessment report to address this recommendation. In December 2016, VHA noted that the Scheduling Resource Assessment tool had been further enhanced and clarified that the training for this tool is not mandatory and use of the tool is optional. Although VHA has developed this and other tools, such as the Clinic Access Report, Wait Time List Report, Missed Opportunity report, it has not developed and implemented a policy that requires VAMCs to routinely assess clinics' scheduling needs and resources. Without such policy, we believe it is not clear how these tools should be used together or who is responsible for assessing scheduling needs and resources and for making operational decisions. To close this recommendation, VA needs to develop a policy that requires its medical centers to routinely assess clinics' scheduling needs and resources to ensure that the allocation of staffing resources is responsive to the demand for scheduling medical appointments.
    Recommendation: To improve timely medical appointments and to address patient and staff complaints about telephone access,the Secretary of VA should direct the Under Secretary for Health to ensure that all VAMCs provide oversight of telephone access and implement best practices outlined in its telephone systems improvement guide.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VA concurred with this recommendation and stated that VISN and VA Medical Center leadership would use best practices to develop and implement improved telephone service plans. As of March 2015, VHA had developed a standardized telephone assessment tool and requested that facilities that care for 5,000 or more veterans complete the assessment and select actions for improvement based on its existing telephone systems improvement guide. Based on this request, VHA received telephone assessment and improvement plans from 286 facilities that care for 5,000 or more veterans. VHA is monitoring the facilities' telephone performance and is re-baselining call center infrastructure at each facility with a survey and new performance goals. In September 2015, VHA issued an updated Telephone Access and Contact Management Improvement Guide. VHA has also drafted an update to its directive on telephone access, but as of January 2017, it had not been published.
    Director: Iritani, Katherine M
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To improve transparency of and accountability for Medicaid non-DSH supplemental payments, Congress should consider requiring the Administrator of CMS to (1) improve state reporting of non-DSH supplemental payments, including requiring annual reporting of payments made to individual facilities and other information that the agency determines is necessary to oversee non-DSH supplemental payments; (2) clarify permissible methods for calculating non-DSH supplemental payments; and (3) require states to submit an annual independent certified audit verifying state compliance with permissible methods for calculating non-DSH supplemental payments.

    Agency: Congress
    Status: Open

    Comments: As of August 2017, no legislation had been enacted although at least one bill had been introduced in the Congress that would implement this Matter. If enacted, H.R. 541 would, among other things, require annual reporting of non-DSH supplemental payments made to individual institutional providers; information on type of ownership of providers that received the supplemental payments; and other information the agency determines is necessary to oversee non-DSH supplemental payments. However, CMS has taken some actions administratively to understand how to improve its oversight, which are underway. CMS had planned to publish a proposed rule for public comment in fall 2016 that could improve the oversight of supplemental payments made to individual providers. As of August 2017, the agency stated that it is gathering information from data submitted by states to better inform individual provider level payment criteria and establish policies and procedures to evaluate whether payments at the provider level are economic and efficient. They expect to complete this process by March 2018. CMS has also awarded a contract to review Medicaid supplemental payment information submitted by states that may, according to CMS officials, provide information to identify areas for future supplemental payment oversight, including issuing additional guidance on non-DSH supplemental payment submissions and developing standardized formatting. CMS reported that in 2016 it received approval from the Office of Management and Budget to issue standardized templates for all states to use when submitting the annual non-DSH supplemental payments for agency review, but did not specify when standard templates would be used. CMS also reported that the agency was developing a tool to assist in reviewing amendments to state plans and analyzing non-DSH supplemental payments. GAO plans to continue to monitor congressional action, as well as CMS's guidance on supplemental payments to individual providers and actions resulting from the contracted review to determine the extent to which improve state reporting of non-DSH supplemental payments, clarify permissible methods for calculating non-DSH supplemental payments, and require audits to verify that states use permissible methods to calculate non-DSH supplemental payments.
    Director: Williamson, Randall B
    Phone: (206)287-4860

    3 open recommendations
    including 2 priority recommendations
    Recommendation: To ensure that servicemembers have equitable access to the military services' wounded warrior programs, including the RCP, and to establish central accountability for these programs, the Secretary of Defense should establish or designate an office to centrally oversee and monitor the activities of the military services' wounded warrior programs to include the following: (1) Develop consistent eligibility criteria to ensure that similarly situated recovering servicemembers from different military services have uniform access to these programs; (2) Direct the military services' wounded warrior programs to fully comply with the policies governing care coordination and case management programs and any future changes to these policies; (3) Develop a common mechanism to systematically monitor the performance of the wounded warrior programs--to include the establishment of common terms and definitions--and report this information on a biannual basis to the Armed Services Committees of the House of Representatives and the Senate.

    Agency: Department of Defense
    Status: Open
    Priority recommendation

    Comments: DOD did not concur with our part (1) of our recommendation to develop consistent eligibility criteria, explaining that the three military department secretaries should have the ability to control entrance criteria into their wounded warrior programs and that varying eligibility criteria have not resulted in noticeable differences in access to these programs by recovering servicemembers or their families. In attachments to a memo dated April 8, 2014, DOD provided an update on progress made to implement parts (2) and (3) of the DOD-specific recommendation made in GAO-13-5. Regarding part (2), DOD reported that budget constraints had delayed its plan to conduct oversight visits to 63 service sites over a 12-month period to ensure that military wounded warrior programs were operating in compliance with DOD Recovery Coordinator Program policy. DOD stated that the Warrior Care Policy office, in coordination with the military service branches, had intended to begin these oversight visits and interviews in September 2013; that as of March 2014, five sites had been reviewed; and that results of the compliance visits would be available upon completion. Regarding part (3) of the recommendation, DOD's memo stated that DOD and VA continue work on developing policies on clinical and non-clinical care coordination. It also noted that interagency metrics for monitoring complex care coordination performance were under development by the DOD/VA Interagency Care Coordination Committee. Further, DOD stated that because the Joint Executive Council publishes an annual report, that reporting the progress in developing common terms and definitions used by wounded warrior programs to congressional committees would be of limited value. As of October 2016, when we determine what additional steps the agency has taken to implement this recommendation, we will update this information.
    Recommendation: To ensure that persistent challenges with care coordination, disability evaluation, and the electronic sharing of health records are fully resolved, the Secretaries of Defense and Veterans Affairs should ensure that these issues receive sustained leadership attention and collaboration at the highest levels with a singular focus on what is best for the individual servicemember or veteran to ensure continuity of care and a seamless transition from DOD to VA. This should include holding the Joint Executive Council accountable for (1) ensuring that key issues affecting recovering servicemembers and veterans get sufficient consideration, including recommendations made by the Warrior Care and Coordination Task Force and the Recovering Warrior Task Force; (2) developing mechanisms for making joint policy decisions; (3) involving the appropriate decision-makers for timely implementation of policy; and; (4) establishing mechanisms to systematically oversee joint initiatives and ensure that outcomes and goals are identified and achieved.

    Agency: Department of Defense
    Status: Open
    Priority recommendation

    Comments: As of October 2016, under the joint DOD/VA Interagency Care Coordination Committee, the departments have made progress to improve nonclinical care coordination procedures, primarily through the development of two initiatives?the Lead Coordinator initiative (in which a single care coordinator serves as the primary point of contact for a recovering servicemember) and through the use of a single, interagency care plan (ICP) for each recovering servicemember. As of March 2016, the departments were continuing the national rollout of the Lead Coordinator initiative and had trained nearly 3,700 DOD and VA personnel on the new process. In addition, DOD and VA continued the development of the ICP initiative, which will depend upon their ability to electronically exchange the information needed to implement servicemembers' care plans. In December 2015, DOD awarded a contract to support the ICP and to create electronic interoperability with VA. The departments anticipate testing their ability to exchange information digitally in June 2016 and achieving full operational capability by September 2016. We will continue to monitor progress to implement the joint Lead Coordinator and the ICP care coordination initiatives.
    Recommendation: To ensure that persistent challenges with care coordination, disability evaluation, and the electronic sharing of health records are fully resolved, the Secretaries of Defense and Veterans Affairs should ensure that these issues receive sustained leadership attention and collaboration at the highest levels with a singular focus on what is best for the individual servicemember or veteran to ensure continuity of care and a seamless transition from DOD to VA. This should include holding the Joint Executive Council accountable for (1) ensuring that key issues affecting recovering servicemembers and veterans get sufficient consideration, including recommendations made by the Warrior Care and Coordination Task Force and the Recovering Warrior Task Force; (2) developing mechanisms for making joint policy decisions; (3) involving the appropriate decision-makers for timely implementation of policy; and; (4) establishing mechanisms to systematically oversee joint initiatives and ensure that outcomes and goals are identified and achieved.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: As of October 2016, under the joint DOD/VA Interagency Care Coordination Committee, the departments have made progress to improve nonclinical care coordination procedures, primarily through the development of two initiatives?the Lead Coordinator initiative (in which a single care coordinator serves as the primary point of contact for a recovering servicemember) and through the use of a single, interagency care plan (ICP) for each recovering servicemember. As of March 2016, the departments were continuing the national rollout of the Lead Coordinator initiative and had trained nearly 3,700 DOD and VA personnel on the new process. In addition, DOD and VA continued the development of the ICP initiative, which will depend upon their ability to electronically exchange the information needed to implement servicemembers' care plans. In December 2015, DOD awarded a contract to support the ICP and to create electronic interoperability with VA. The departments anticipate testing their ability to exchange information digitally in June 2016 and achieving full operational capability by September 2016. We will continue to monitor progress to implement the joint Lead Coordinator and the ICP care coordination initiatives.
    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: Draper, Debra A
    Phone: (202)512-3000

    6 open recommendations
    Recommendation: To facilitate the departments' current collaboration efforts, VA and DOD should systematically identify areas where department-level actions could help address significant barriers that hinder collaboration. Specifically, the Secretaries of Veterans Affairs and Defense should expedite and communicate a plan with time frames for when iEHR solutions will be made available to joint ventures and other collaboration sites.

    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 facilitate the departments' current collaboration efforts, VA and DOD should systematically identify areas where department-level actions could help address significant barriers that hinder collaboration. Specifically, the Secretaries of Veterans Affairs and Defense should expedite and communicate a plan with time frames for when iEHR solutions will be made available to joint ventures and other collaboration sites.

    Agency: Department of Veterans Affairs
    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 facilitate the departments' current collaboration efforts, VA and DOD should systematically identify areas where department-level actions could help address significant barriers that hinder collaboration. Specifically, the Secretaries of Veterans Affairs and Defense should take steps to resolve problems with collaboration sites' incompatible business and administrative processes, including reimbursement for services, collection of workload information, dual credentialing, and computer security training.

    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 facilitate the departments' current collaboration efforts, VA and DOD should systematically identify areas where department-level actions could help address significant barriers that hinder collaboration. Specifically, the Secretaries of Veterans Affairs and Defense should take steps to resolve problems with collaboration sites' incompatible business and administrative processes, including reimbursement for services, collection of workload information, dual credentialing, and computer security training.

    Agency: Department of Veterans Affairs
    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 facilitate the departments' current collaboration efforts, VA and DOD should systematically identify areas where department-level actions could help address significant barriers that hinder collaboration. Specifically, the Secretaries of Veterans Affairs and Defense should clarify, as part of the newly initiated joint efforts to address base access, departmental guidance regarding collaboration to include a discussion of base access issues that local officials should consider when discussing and planning collaboration efforts; this could include a discussion of successful approaches that current collaboration sites have adopted to facilitate base access for veterans and their escorts.

    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 facilitate the departments' current collaboration efforts, VA and DOD should systematically identify areas where department-level actions could help address significant barriers that hinder collaboration. Specifically, the Secretaries of Veterans Affairs and Defense should clarify, as part of the newly initiated joint efforts to address base access, departmental guidance regarding collaboration to include a discussion of base access issues that local officials should consider when discussing and planning collaboration efforts; this could include a discussion of successful approaches that current collaboration sites have adopted to facilitate base access for veterans and their escorts.

    Agency: Department of Veterans Affairs
    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: 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: 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: Draper, Debra A
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: To clarify IT requirements within the Executive Agreement, to enable VA and DOD to make an informed recommendation about whether the FHCC should continue after the end of the demonstration, and to provide useful information for other integrations that may be considered in the future, the Secretaries of Veterans Affairs and Defense should develop plans with clear definitions and specific deliverables, including time frames for two IT capabilities-documentation of patient care to support medical and dental operational readiness and outpatient appointment enhancements-and formalize these plans, for example, by incorporating them into the Executive Agreement.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: As of July 2017, VA and 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 clarify IT requirements within the Executive Agreement, to enable VA and DOD to make an informed recommendation about whether the FHCC should continue after the end of the demonstration, and to provide useful information for other integrations that may be considered in the future, the Secretaries of Veterans Affairs and Defense should develop plans with clear definitions and specific deliverables, including time frames for two IT capabilities-documentation of patient care to support medical and dental operational readiness and outpatient appointment enhancements-and formalize these plans, for example, by incorporating them into the Executive Agreement.

    Agency: Department of Defense
    Status: Open

    Comments: As of July 2017, VA and 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: 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: Williamson, Randall B
    Phone: (202)512-3000

    2 open recommendations
    Recommendation: In order to better inform future budget requests, the Secretary of Veterans Affairs should develop a sound methodology for estimating savings from new operational improvements. This methodology should include: (1) an explanation of how savings from each operational improvement will be achieved; (2) an explanation for the basis of any assumptions included in the savings estimates; and (3) an implementation plan that includes a realistic timeline for implementation, to help ensure that savings can be achieved within the targeted time frame.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: In February 2012, we recommended that the Department of Veterans Affairs (VA) develop a sound methodology for estimating savings from new operational improvements in future budget submissions. While VA concurred with this recommendation, in June 2016, VA reported that it intends to implement this recommendation when new operational improvements are proposed in the budget. However, recent budget submissions have not included operational improvements.
    Recommendation: The Secretary of Veterans Affairs should develop a detailed process for tracking VA's actual savings resulting from those operational improvements for which we identified concerns. This process should provide detailed written guidance for those responsible for tracking the savings, which outlines the methodology for calculating savings.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: In February 2012, we recommended that the Department of Veterans Affairs (VA) develop a detailed process for tracking VA's actual savings resulting from those operational improvements for which we identified concerns. While VA partially concurred with this recommendation, in June 2016, VA reported that it has no future plans to fully implement this recommendation.
    Director: Cosgrove, James C
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: To further align Medicare beneficiary use of preventive services with Task Force recommendations, Congress may wish to consider requiring beneficiaries who receive services with a grade of 'D" to share the cost, notwithstanding that cost sharing may not be required for other beneficiaries receiving the same services.

    Agency: Congress
    Status: Open

    Comments: Congress has not yet taken action to require beneficiaries who receive services with a Task Force grade of "D" to share the cost.
    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: Crosse, Marcia G
    Phone: 202-512-3407

    3 open recommendations
    Recommendation: In order to ensure that federal efforts to prevent the abuse and misuse of prescription pain relievers are an effective and efficient use of limited government resources, the Director of ONDCP should establish outcome metrics and identify resources for conducting outcome evaluations for the national education campaigns about prescription drug abuse and safe storage and disposal proposed in the Prescription Drug Abuse Prevention Plan.

    Agency: Office of National Drug Control Policy
    Status: Open

    Comments: In June, 2016, we requested an update from ONDCP on the status of its efforts to implement this recommendation. We have not received a response. We will update the status of this recommendation when we receive additional information.
    Recommendation: In order to ensure that federal efforts to prevent the abuse and misuse of prescription pain relievers are an effective and efficient use of limited government resources, the Director of ONDCP should develop and implement a plan to evaluate outcomes from the proposed national education campaigns.

    Agency: Office of National Drug Control Policy
    Status: Open

    Comments: In June, 2016, we requested an update from ONDCP on the status of its efforts to implement this recommendation. We have not received a response. We will update the status of this recommendation when we receive additional information.
    Recommendation: In order to ensure that federal efforts to prevent the abuse and misuse of prescription pain relievers are an effective and efficient use of limited government resources, the Director of ONDCP should ensure that federal agencies undertaking similar educational efforts leverage available resources and use coordination mechanisms to share information on the development of their efforts.

    Agency: Office of National Drug Control Policy
    Status: Open

    Comments: In June, 2016, we requested an update from ONDCP on the status of its efforts to implement this recommendation. We have not received a response. We will update the status of this recommendation when we receive additional information.
    Director: Williamson, Randall B
    Phone: (202)512-3000

    8 open recommendations
    Recommendation: To help ensure that the military services' requirements for physician credentialing and privileging are consistent across the MHS, the Secretary of Defense should direct the Assistant Secretary of Defense for Health Affairs and the Surgeons General of the military services to establish a DOD-wide process to identify and address existing inconsistencies between DOD's and the military services' physician credentialing and privileging requirements, including those inconsistencies we identified in this report.

    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 help ensure that the military services' requirements for physician credentialing and privileging are consistent across the MHS, the Secretary of Defense should direct the Assistant Secretary of Defense for Health Affairs and the Surgeons General of the military services to establish a DOD-wide process to coordinate all current and future efforts to revise physician credentialing and privileging requirements.

    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 assure that information on a physician's clinical competence and practice history is documented and available to support credentialing and privileging decisions by Army MTFs, the Secretary of Defense should direct the Assistant Secretary of Defense for Health Affairs and the Army Surgeon General to coordinate individual MTFs' efforts to establish mechanisms to collect and analyze data to evaluate physician performance and support performance assessments.

    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 assure that information on a physician's clinical competence and practice history is documented and available to support credentialing and privileging decisions by Army MTFs, the Secretary of Defense should direct the Assistant Secretary of Defense for Health Affairs and the Army Surgeon General to clarify requirements for how MTFs document follow-up on peer recommendations, including who is responsible for documenting follow-up and where that documentation should be filed.

    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 assure that information on a physician's clinical competence and practice history is documented and available to support credentialing and privileging decisions by Army MTFs, the Secretary of Defense should direct the Assistant Secretary of Defense for Health Affairs and the Army Surgeon General to clarify requirements for the information that physicians need to provide in their curriculum vitae (CV) so that MTFs can identify unaccounted for periods in practice history, as well as how MTFs should document explanations of any unaccounted for periods.

    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 assure that information on a physician's clinical competence and practice history is documented and available to support credentialing and privileging decisions by Army MTFs, the Secretary of Defense should direct the Assistant Secretary of Defense for Health Affairs and the Army Surgeon General to establish requirements for MTFs to document significant events that occur during the review of a credentials file, including which types of significant events should be documented, who is responsible for documenting significant events, and where that documentation should be filed.

    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 assure that information on a physician's clinical competence and practice history is documented and available to support credentialing and privileging decisions by Army MTFs, the Secretary of Defense should direct the Assistant Secretary of Defense for Health Affairs and the Army Surgeon General to establish a process to ensure that relevant information from the DPDB is documented in the credentials file.

    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 assure that MTFs are fully complying with DOD's and the military services' requirements for physician credentialing and privileging and implementing these requirements appropriately, the Secretary of Defense should direct the Surgeons General of the military services to establish and implement an oversight process to conduct reviews of a sample of credentials files to identify and address areas of noncompliance and incomplete documentation.

    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: Yocom, Carolyn L
    Phone: (202)512-4931

    1 open recommendations
    Recommendation: To ensure that federal funding efficiently and effectively responds to the countercyclical nature of the Medicaid program, Congress may wish to consider enacting an FMAP formula that is targeted for variable state Medicaid needs and provides automatic, timely, and temporary increased FMAP assistance in response to national economic downturns.

    Agency: Congress
    Status: Open

    Comments: On February 10, 2016, GAO testified on considerations related to the Medicaid funding formula. See Medicaid: Changes to Funding Formula Could Improve Allocation of Funds to States GAO-16-377T January 26, 2016. We also cited this report in our discussion on Medicaid funding during economic downturns in Medicaid: Key Policy and Data Considerations for Designing a Per Capita Cap on Federal Funding(GAO-16-726).
    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: 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: Williamson, Randall B
    Phone: (206)287-4860

    1 open recommendations
    Recommendation: To help identify risks and address vulnerabilities in physical security precautions at VA medical facilities, the Secretary of Veterans Affairs should direct the Under Secretary for Health to require relevant medical center stakeholders to coordinate and consult on (1) plans for new and renovated units, and (2) any changes to physical security features, such as closed-circuit television cameras.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Trimble, David C
    Phone: (202)512-9338

    4 open recommendations
    Recommendation: To increase EPA's consistency, transparency, and clarity in implementing the Safe Drinking Water Act in a way that better assures the public of safe drinking water, and to systematically implement the statutory requirement to consider for regulation the contaminants that present the greatest public health concern, the EPA Administrator should require that the Office of Water to develop a coordinated process for obtaining both the occurrence and health effects data that may be needed for the agency to make informed regulatory determinations on these priority contaminants.

    Agency: Environmental Protection Agency
    Status: Open

    Comments: EPA has not demonstrated that it has developed a coordinated process for obtaining both occurrence and health effects data to make informed determinations on priority contaminants. EPA's response to this recommendation is that it will continue the status quo of obtaining occurrence data through UCMRs and work with the Office of Research and Development. As we reported, the approach EPA currently uses does not provide the agency with all of the data it needs in a timely manner to support determinations for some priority contaminants.
    Recommendation: To increase EPA's consistency, transparency, and clarity in implementing the Safe Drinking Water Act in a way that better assures the public of safe drinking water, and to support the development of regulatory determinations that are transparent, clear, and consistent and that follow applicable agency policy, the EPA Administrator should require the Office of Water to expeditiously develop, and make available to the public, policies or guidance that clearly articulates the agency's interpretation of the act's broad statutory criteria for making regulatory determinations and provides a protocol for making such determinations. In particular, the guidance should establish a process to ensure that the presentation of health effects and occurrence information in regulatory determination notices and support documents is comprehensive, consistent, informative, and understandable and that it includes clear explanations of key information, such as any exceptions to existing guidance reflected in the agency's support for its regulatory determinations.

    Agency: Environmental Protection Agency
    Status: Open

    Comments: EPA's Preliminary Regulatory Determinations for Contaminants on the Third Drinking Water Contaminant Candidate List (Reg Det 3) did not appear to include any cases in which EPA made an exception to existing guidance, negating the need for an explanation. EPA has not developed policies or guidance that establishes a process to ensure that the presentation of health effects and occurrence information in regulatory determination notices and support documents is comprehensive, consistent, informative, and understandable, and that it includes clear explanations of key information and the Protocol for Regulatory Determinations 3 does not appear to address this circumstance. Without policies or guidance establishing a process to ensure the comprehensive, consistent, informative, and understandable presentation of its regulatory determinations, there is no guarantee at this time that EPA would include this information in future regulatory determinations.
    Recommendation: To increase EPA's consistency, transparency, and clarity in implementing the Safe Drinking Water Act in a way that better assures the public of safe drinking water, and to support the development of regulatory determinations that are transparent, clear, and consistent and that follow applicable agency policy, the EPA Administrator should require the Office of Water to expeditiously develop, and make available to the public, policies or guidance that clearly articulates the agency's interpretation of the act's broad statutory criteria for making regulatory determinations and provides a protocol for making such determinations. In particular, the guidance should specify that appropriate stakeholders--that is, EPA offices with relevant expertise such as the Office of Children's Health Protection and regional offices that have known or likely occurrence of the contaminants being evaluated in public water systems within their areas of jurisdiction--be encouraged and have the opportunity to participate in the regulatory determination work groups.

    Agency: Environmental Protection Agency
    Status: Open

    Comments: EPA's response to this recommendation reflects the practice that was in place at the time we issued our report including this recommendation. As a result, it does not appear that EPA has taken any additional action to satisfy this recommendation at this time.
    Recommendation: In light of EPA's decisions to issue health advisories in conjunction with determinations to not regulate certain contaminants that have been detected in some public water systems at levels of public health concern, the EPA Administrator should (1) determine whether the Office of Water's use of health advisories provides sufficient information on these unregulated contaminants to support timely and effective actions by states, localities, public water systems, and the public to ensure the safety of public drinking water, and (2) if not, direct the Office of Water to develop a plan to more effectively communicate such information to these entities.

    Agency: Environmental Protection Agency
    Status: Open

    Comments: EPA indicated that it has begun a process of developing concise updates to carry forward into its health advisory table and that the process will be completed gradually over the next year, with updates continuing in the future, but has not yet published any updates for non-microbial contaminants. In addition, EPA has not addressed the call in the recommendation for the documentation of the process to update the advisories. The agency did indicate its plan to update the Drinking Water Standards and Health Advisory table in the fall of 2016, so we will leave this recommendation open and continue to monitor for future actions.
    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: 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: Cosgrove, James C
    Phone: (202)512-7029

    2 open recommendations
    Recommendation: Congress may wish to consider reducing home oxygen payment rates to better align them with home oxygen suppliers' costs.

    Agency: Congress
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    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: Mccool, Thomas J
    Phone: (202)512-8678

    1 open recommendations
    Recommendation: In developing legislation for a national reporting system for the biological laboratory community, Congress may wish to consider provisions for the agency it designates as responsible for the system to take into account the following in design and implementation: (1) including stakeholders in setting system goals; (2) assessing labs' organizational culture to guide design and implementation decisions; (3) making reporting voluntary, with open-reporting formats that allow workers to report events in their own words and that can be submitted by all workers in a variety of modes (Web or postal), with the option to report to either an internal or external entity; (4) incorporating strong reporter protections, data deidentification measures, and other incentives for reporting; (5) developing feedback mechanisms and an industry-level entity for disseminating safety data and safety recommendations across the lab community; and (6) ensuring ongoing monitoring and evaluation of the safety reporting system and safety culture.

    Agency: Congress
    Status: Open

    Comments: Congress has not taken action on this recommendation.
    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: 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: Williamson, Randall B
    Phone: (206)287-4860

    1 open recommendations
    Recommendation: To help DOD obtain reasonable assurance that all active and Reserve component servicemembers to whom the PDHRA requirement applies are provided the opportunity to have their health concerns identified, the Assistant Secretary of Defense for Health Affairs and the military services should take steps to ensure that PDHRA questionnaires are included in DOD's central repository for each of these servicemembers.

    Agency: Department of Defense
    Status: Open

    Comments: In its comments to this report, the Department of Defense (DOD) concurred with this recommendation. On October 2009, DOD's Force Health Protection and Response Office sent a memo to each of the military service Surgeons General emphasizing the need for the post-deployment health reassessment (PDHRA) to be offered to all service members who are eligible to complete the assessment. In 2010, DOD's noted that the services would work with the Armed Forces Health Surveillance Center (AFHSC) repository to ensure PDHRAs are submitted correctly, without transmission errors. DOD's 2011 case records showed that the Air Force and Army had developed data verification processes to ensure that AFHSC received PDHRAs. Further, the Defense Medical Data Center (DMDC) had planed to create a file consisting of the date of deployment for deployed personnel, and that the file would be available to the services in order to match DMDC with data from each of the service-specific systems, in accordance to requirements. In September 2011, although DMDC and the services had agreed to match rosters of deployed service members, there were still inconsistencies in deployment dates. In March 2012, DOD was still verifying data inconsistencies which, until resolved, leads to inaccurate reporting based on errors in the deployment dates.
    Director: Cosgrove, James C
    Phone: (202)512-7029

    1 open recommendations
    Recommendation: To ensure that savings are realized from the implementation of an MPPR or other policies that reflect efficiencies occurring when services are furnished together, Congress may wish to consider exempting these savings from budget neutrality.

    Agency: Congress
    Status: Open

    Comments: As of May 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: 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: Iritani, Katherine
    Phone: (212) 512-3000

    2 open recommendations
    Recommendation: Congress may wish to consider requiring increased attention to fiscal responsibility in the approval of section 1115 Medicaid demonstrations by requiring the Secretary of HHS to improve the demonstration review process through steps such as (1) clarifying criteria for reviewing and approving states' proposed spending limits, (2) better ensuring that valid methods are used to demonstrate budget neutrality, and (3) documenting and making public material explaining the basis for any approvals.

    Agency: Congress
    Status: Open

    Comments: As of July 2015, no legislation on this topic had been passed, although at least one bill had been introduced in Congress that would make budget neutrality a statutory requirement for Medicaid demonstrations.The House Energy and Commerce Committee held a hearing in June 2015 examining HHS's approval of spending under Medicaid demonstrations. In addition, the House Oversight and Government Reform and House Energy and Commerce Committees had sent letters to the Administration inquiring as to how HHS was responding to GAO findings and recommendations to improve the process and methods used to set demonstration spending limits.
    Recommendation: Congress may wish to consider addressing whether demonstrations that allow states to operate public managed care organizations and retain excess revenue to support programs previously funded by the state--including the Vermont demonstration--are within the scope of the Secretary of HHS's authority under section 1115 of the Social Security Act.

    Agency: Congress
    Status: Open

    Comments: As of July 2015, Congress had not passed legislation in response to our matter for congressional consideration.
    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.