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    Results:

    Subject Term: Drugs

    26 publications with a total of 49 open recommendations including 1 priority recommendation
    Director: Elizabeth H. Curda
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: The Assistant Secretary for Planning and Evaluation should establish performance measures with targets related to expanding access to MAT for opioid use disorders. (Recommendation 1)

    Agency: Department of Health and Human Services
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Assistant Secretary for Planning and Evaluation should establish timeframes in its evaluation approach that specify when its evaluation of efforts to expand access to MAT will be implemented and completed. (Recommendation 2)

    Agency: Department of Health and Human Services
    Status: Open

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

    5 open recommendations
    Recommendation: To help ensure that efforts to address smuggling through cross-border tunnels, ultralight aircraft, panga boats, and recreational vessels are effective and that managers and stakeholders have the information needed to make decisions, the Secretary of Homeland Security should direct the Commissioner of CBP to assess and document how the alternative technological solutions being considered will fully meet operational needs related to ultralight aircraft.

    Agency: Department of Homeland Security
    Status: Open

    Comments: DHS concurred with this recommendation and stated that it plans to assess and document requirements related to ultralight aircraft threats and how technological solutions will address these requirements as part of U.S. Customs and Border Protection Air and Marine Operations air domain awareness efforts. DHS plans to complete these efforts by July 2018.
    Recommendation: To help ensure that efforts to address smuggling through cross-border tunnels, ultralight aircraft, panga boats, and recreational vessels are effective and that managers and stakeholders have the information needed to make decisions, the Secretary of Homeland Security should direct the Commissioner of CBP and the Director of ICE to jointly establish and monitor performance measures and targets related to cross-border tunnels.

    Agency: Department of Homeland Security
    Status: Open

    Comments: DHS concurred with this recommendation and stated that U.S. Customs and Border Protection and U.S. Immigration and Customs Enforcement will review available information and develop performance measures and targets as deemed appropriate by February 2018.
    Recommendation: To help ensure that efforts to address smuggling through cross-border tunnels, ultralight aircraft, panga boats, and recreational vessels are effective and that managers and stakeholders have the information needed to make decisions, the Secretary of Homeland Security should direct the Commissioner of CBP to establish and monitor performance targets related to ultralight aircraft.

    Agency: Department of Homeland Security
    Status: Open

    Comments: DHS concurred and stated that within U.S. Customs and Border Protection, Air and Marine Operations and the U.S. Border Patrol are developing a joint performance measure and targets for interdicting ultralight aircraft. DHS plans to complete these efforts by October 2017.
    Recommendation: To help ensure that efforts to address smuggling through cross-border tunnels, ultralight aircraft, panga boats, and recreational vessels are effective and that managers and stakeholders have the information needed to make decisions, the Secretary of Homeland Security should direct the U.S. Customs and Border Protection (CBP)-U.S. Immigration and Customs Enforcement (ICE) tunnel committee to convene and establish standard operating procedures for addressing cross-border tunnels, including procedures for sharing information.

    Agency: Department of Homeland Security
    Status: Open

    Comments: DHS did not concur with this recommendation. However, CBP and ICE agreed that strengthening operational procedures may be beneficial and stated that they will jointly review procedures and discuss revising and/or consolidating the procedures. We continue to believe that the recommendation is valid and will monitor DHS's efforts to address it.
    Recommendation: To help ensure that efforts to address smuggling through cross-border tunnels, ultralight aircraft, panga boats, and recreational vessels are effective and that managers and stakeholders have the information needed to make decisions, the Secretary of Homeland Security should direct the Commandant of the Coast Guard, Commissioner of CBP, and the Director of ICE to establish and monitor Regional Coordinating Mechanisms performance measures and targets related to panga boat and recreational vessel smuggling.

    Agency: Department of Homeland Security
    Status: Open

    Comments: DHS did not concur with this recommendation. DHS stated that that it believes that by establishing common terminology to address our first recommendation, the RECOMs will have more reliable, usable analyses to inform their maritime interdiction efforts. However, DHS did not believe that performance measures and targets related to smuggling by panga boats would provide the most useful strategic assessment of operations to prevent all illicit trafficking, regardless of area of operations or mode of transportation. DHS also cited the recent creation of the DHS Office of Policy, Strategy, and Plans that is to work with U.S. Coast Guard, U.S. Customs and Border Protection, U.S. Immigration and Customs Enforcement, and other components and offices to better evaluate the effectiveness of all operations that work to prevent the illegal entry of goods and people into the country, as appropriate. We continue to believe that the recommendation is valid and will monitor DHS's efforts to address it.
    Director: Kay E. Brown
    Phone: (202) 512-7215

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

    Agency: Department of Health and Human Services
    Status: Open

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

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

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

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

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

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

    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: Jennifer Grover
    Phone: (202) 512-7141

    2 open recommendations
    Recommendation: The Attorney General should direct ODAG to document a plan specifying DOJ's process for monitoring the effects of marijuana legalization under state law, in accordance with DOJ's 2013 marijuana enforcement policy guidance, to include the identification of the various data ODAG will use and their potential limitations for monitoring the effects of state marijuana legalization, and how ODAG will use the information sources in its monitoring efforts to help inform decisions on whether state systems are effectively protecting federal marijuana enforcement priorities.

    Agency: Department of Justice
    Status: Open

    Comments: The Department of Justice (DOJ) concurred with the recommendation and reported plans to implement it. In October 2016, officials reported that several DOJ components have met and taken steps to compile sources of relevant data, and that the Attorney General's Advisory Committee Marijuana Working Group continues to conduct regular discussions about marijuana. In November 2017, officials reported that the marijuana subcommittee of the Attorney General's Task Force on Crime Reduction and Public Safety is reviewing DOJ's marijuana policy, which includes a review of relevant data sources, as well as outreach to relevant stakeholders, including state and local officials. DOJ officials reported that they will provide additional details about the departments monitoring plan once its review of marijuana policy is complete.
    Recommendation: The Attorney General should direct ODAG to use existing mechanisms to share DOJ's monitoring plan with appropriate officials from DOJ components responsible for providing information DOJ reports using regarding the effects of state legalization to ODAG, obtain feedback, and incorporate the feedback into its plan.

    Agency: Department of Justice
    Status: Open

    Comments: DOJ concurred with the recommendation and reported plans to implement it. In October 2016, officials reported that several DOJ components have met and taken steps to compile sources of relevant data, and that the Attorney General's Advisory Committee Marijuana Working Group continues to conduct regular discussions about marijuana. In November 2017, officials reported that the marijuana subcommittee of the Attorney General's Task Force on Crime Reduction and Public Safety is reviewing DOJ's marijuana policy, which includes a review of relevant data sources, as well as outreach to relevant stakeholders, including state and local officials. DOJ officials reported that they will provide additional details about the department's monitoring plan once its review of marijuana policy is complete.
    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: 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: 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: 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: 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: 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: Gomez, Jose A
    Phone: (202) 512-3841

    1 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.
    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: 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: Cosgrove, James C
    Phone: (202)512-7029

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

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

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

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

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

    1 open recommendations
    Recommendation: To 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: Siggerud, Katherine A
    Phone: (202)512-3000

    1 open recommendations
    Recommendation: Taking action to address the challenges FMCSA faces to ensure that its drug testing program detects drivers who are using illegal drugs, and to keep drivers who have tested positive off the road until they have completed the return-to-duty process, provides an opportunity to improve safety on the roads. In order to assist the Department of Transportation (DOT) and FMCSA in addressing these challenges, and thereby improving road safety, Congress may wish to consider adopting legislation to ban subversion products.

    Agency: Congress
    Status: Open

    Comments: On February 4, 2009, Representative Engel introduced the Drug Testing Integrity Act of 2009 in the House of Representatives. The Act would ban products designed to defraud drug tests. On February 15, 2011 Representative Engel re-introduced the bill, which was referred to the House Committee on Energy and Commerce and then to the Subcommittee on Commerce, Manufacturing, and Trade. Representative Engel re-introduced the bill in the 113th Congress in May of 2013. However, the bill has not been reintroduced since.