Recommendation: The Director of BOP should develop and document the agency's methods for determining the number of additional agency personnel it reports needing to support its MAT program expansion. (Recommendation 1)

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

Comments: BOP concurred with this recommendation and is taking steps to implement it. Specifically, as of June 2020, BOP stated it is working to identify the number of additional agency personnel needed to support its MAT program expansion, including evaluating existing program requirements and consulting with external subject matter experts. To fully address this recommendation, BOP will need to provide documentation on how it determined the number of additional agency personnel it needs to fully implement the MAT program.

Recommendation: The Director of BOP should document how the agency plans to recruit and onboard additional personnel for expanding and implementing the MAT program. (Recommendation 2)

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

Comments: BOP concurred with this recommendation and is taking steps to implement it. Specifically, as of June 2020, BOP stated that its recruiters for medical personnel positions needed to implement the MAT program were being trained to focus on promising candidates within a larger pool. Additionally, BOP stated that market factors had been established to incentivize new applicants and existing BOP personnel to engage in the MAT program. To fully implement this recommendation, BOP must provide more information and documentation supporting these steps, and additionally, provide information on how these and other steps relate to BOP's plans for recruiting and onboarding necessary personnel.

Recommendation: The Director of BOP should develop and document time frames and target goals for key milestones—including a completion date—for the MAT program expansion. (Recommendation 3)

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

Comments: BOP concurred with this recommendation and, as of June 2020, indicated that it continues to develop and adjust target goals and milestones for MAT services expansion leading to full nationwide implementation. To fully implement this recommendation, BOP will need to provide evidence that it has developed and documented time frames and target goals for expanding the MAT program, including a target date for when the MAT program expansion will be completed.

Recommendation: The Director of BOP should update its program evaluation plan to include the MAT program and re-prioritize the time frames for evaluating all programs in the plan based on available funding and staffing levels for conducting evaluations. (Recommendation 4)

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

Comments: BOP concurred with this recommendation and indicated in June 2020 that it would provide GAO with an updated program evaluation plan. To fully implement this recommendation, BOP will need to provide this updated plan along with supporting documentation outlining BOP's process for updating it.

Recommendation: The Director of BOP should implement the revised program evaluation plan based on available funding and staffing levels for conducting them. (Recommendation 5)

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

Comments: BOP concurred with this recommendation and is taking steps to implement it.

Recommendation: The Director of BOP should develop and document a plan for managing its portfolio of drug education and treatment programs, including the MAT program. This plan should, among other components, identify specific activities and resources necessary to achieve desired results. (Recommendation 6)

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

Comments: BOP concurred with this recommendation and is taking steps to implement it. Specifically, as of June 2020, BOP stated it will develop a portfolio management plan to ensure necessary resources are secured and appropriately allocated in a manner consistent with the agency's strategic plan. To fully implement this recommendation, BOP will need to develop this plan to include, among other components, specific activities and resources necessary to effectively manage its portfolio of drug education and treatment programs.

Recommendation: The Director of BOP should implement BOP's plan for managing its portfolio of drug education and treatment programs. (Recommendation 7)

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

Comments: BOP concurred with this recommendation and is taking steps to implement it.

Recommendation: In order for drug sponsors to benefit from FDA's revised guidance on antibiotic development and take full advantage of the QIDP designation, FDA should develop and make available written guidance on the QIDP designation that includes information about the process a drug sponsor must undertake to request the fast track designation and how the agency is applying the market exclusivity incentive.

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

Comments: According to HHS, FDA issued draft guidance (a document of frequently asked questions) in January of 2018 that describes the QIDP designation. However, this document is in draft form and has not yet been finalized. As of August 2020, FDA reported it is working to finalize this guidance this year. GAO will revisit this recommendation when the final guidance is issued.

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 November 2019, FDA released for public comment its new Draft Guidance for Industry #256 - Compounding Animal Drugs from Bulk Drug Substances. The draft guidance describes FDA's policy regarding the compounding of animal drugs from bulk drug substances including the conditions under which FDA does not intend to take enforcement action for violations of the Federal Food, Drug, and Cosmetic Act's requirements for approval, adequate directions for use, and current Good Manufacturing Practices. We will review the updated guidance when it is finalized and determine if it addresses this recommendation. In August 2020, FDA indicated that, in response to numerous requests from external stakeholders, the comment period on the draft guidance has been extended to October 2020. Once the comments have been reviewed, FDA anticipates finalizing the guidance by the end of calendar year 2021.

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: In July 2019, FDA reported to GAO that when the Draft Guidance for Industry #256 was issued that calendar year, FDA intended to develop a risk-based compliance program to address compounding of animal drugs from bulk drug substances. As part of that compliance program, FDA reported that it intended to consistently document the basis for its decisions about what actions are taken, for example, warning letters, adverse event reports, and complaints. In August 2020, FDA reported that a working group has been formed to develop a risk-based compliance strategy, which will include a process for documenting the basis for FDA's decisions about how or whether it followed up on warning letters, adverse event reports, and complaints about drug compounding for animals. FDA anticipates implementing this strategy simultaneously with the finalization of Guidance for Industry #256, which is anticipated to occur at the end of calendar year 2021. We will follow-up with FDA regarding these actions and determine if the actions address our recommendation.

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 an October 2018 written response, Health and Human Services (HHS) noted that they released 2017-2018 Drug Utilization Review Summaries for Prescription Drug Fee-For-Service Programs as it relates to national statistics on state oversight of psychotropic medications, as well as new state requirements to report on their Medicaid managed care organizations. However, as of August 2019, HHS confirmed they have not issued any 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, as we recommended. 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.

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: CMS, as required by the Protecting Access to Medicare Act of 2014 (PAMA), delayed until 2024 when the bundled payment for dialysis care is expanded to cover oral-only ESRD drugs. Because PAMA requires CMS to use the most recent year of data available to implement this payment change, CMS has been unable to implement our recommendation. We will update the status of this recommendation upon receipt of additional information from CMS.