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    Subject Term: "Prescription drugs"

    25 publications with a total of 49 open recommendations including 3 priority recommendations
    Director: Elizabeth H. Curda
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: The Administrator of CMS should gather information over time on the number of beneficiaries at risk of harm from opioids, including those who receive high opioid morphine equivalent doses regardless of the number of pharmacies or providers, as part of assessing progress over time in reaching the agency's goals related to reducing opioid use. (Recommendation 1)

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Administrator of CMS should require its contractor, National Benefit Integrity Medicare Drug Integrity Contractor, to identify and conduct analyses on providers who prescribe high amounts of opioids separately from providers who prescribe high amounts of any Schedule II drug. (Recommendation 2)

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Administrator of CMS should require plan sponsors to report to CMS on investigations and other actions taken related to providers who prescribe high amounts of opioids. (Recommendation 3)

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    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: Seto Bagdoyan
    Phone: (202) 512-6722

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

    Agency: Department of Health and Human Services
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To enhance consumer understanding of agency oversight roles and to strengthen agency oversight of Internet marketing, the Secretary of the Department of Health and Human Services and the Chair of the FTC should develop and provide additional guidance to consumers delineating the agencies' differing roles in their shared oversight of memory supplement and other dietary supplement marketing on the Internet.

    Agency: Federal Trade Commission
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Diana Maurer
    Phone: (202) 512-8777

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

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

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

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

    Comments: As of April 2017, according to the Department of Health and Human Services, SAMHSA will develop a plan to ensure complete and accurate information is provided to ONDCP by the end of summer 2017.
    Director: John 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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.