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: The Director of CDC should take steps to determine participation rates and distribution needed in the AR Option of the National Healthcare Safety Network for conducting regional and national assessments of antibiotic resistance of public health importance. (Recommendation 1)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
Status: Open

Comments: The Department of Health and Human Services concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Director of CDC should ensure that CDC's evaluation of its surveillance system for antibiotic-resistant gonorrhea includes measures of its representativeness, such as comparison of the trends in the sample population with those in the overall U.S. population, using specially designed studies if needed. (Recommendation 2)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
Status: Open

Comments: The Department of Health and Human Services and the Centers for Disease Control and Prevention concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Director of CDC should provide information on uncertainties for antibiotic resistance estimates in its consolidated Threats Reports, including standard errors or confidence intervals, as appropriate. (Recommendation 3)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
Status: Open

Comments: The Department of Health and Human Services generally concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Director of CDC should develop a plan for timely, consolidated reports of antibiotic resistance in priority pathogens at regular intervals. (Recommendation 4)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
Status: Open

Comments: The Department of Health and Human services concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Secretary of HHS should identify leadership and clarify roles and responsibilities among HHS agencies to assess the clinical outcomes of diagnostic testing for identifying antibiotic-resistant bacteria. (Recommendation 5)

Agency: Department of Health and Human Services: Office of the Secretary
Status: Open

Comments: The Department of Health and Human Services concurred with GAO's recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should direct the Center for Devices and Radiological Health to conduct additional monitoring and evaluation of the status of FDA-authorized tests that rely on breakpoints, on a regular basis, to determine whether test manufacturers are updating breakpoints, seeking additional resources as needed. (Recommendation 6)

Agency: Department of Health and Human Services: Public Health Service: Food and Drug Administration: Office of the Commissioner
Status: Open

Comments: The Department of Health and Human Services and the Food and Drug Administration concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Secretary of HHS should develop a strategic framework to further incentivize the development of new treatments for antibiotic-resistant infections, including through the use of postmarket financial incentives, and, if appropriate, make recommendations to Congress for necessary authority. (Recommendation 7)

Agency: Department of Health and Human Services: Office of the Secretary
Status: Open

Comments: The Department of Health and Human Services did not concur with GAO's recommendation. In commenting on our report, the department noted that it has convened a workgroup to develop a strategic framework that includes proposals to address a variety of challenges facing antibiotic product developers and agreed that additional incentives are needed. However, the department stated it is still analyzing whether postmarket financial incentives should be included in this framework. We believe our recommendation is still warranted, given the importance of antibiotic resistance to public health and the importance of sustaining the antibiotic pipeline, including after antibiotics are brought to market. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Secretary of HHS should direct the CARB Task Force to include in its annual updates to the President plans for addressing any barriers preventing full implementation of the National Action Plan and, as appropriate, make recommendations for new or modified actions. Specifically, the CARB Task Force should identify plans to address barriers, such as those related to expanding (1) a CDC program designed to strengthen the U.S. response to resistant gonorrhea; (2) antibiotic stewardship programs across health care settings; and (3) antibiotic use data collection across health care settings, to the extent feasible. (Recommendation 8)

Agency: Department of Health and Human Services: Office of the Secretary
Status: Open

Comments: The Department of Health and Human Services concurred with this recommendation, and stated that beginning in 2020 and continuing annually thereafter, the CARB Task Force's progress reports will include discussion of any barriers preventing full implementation of the National Action Plan, including, as appropriate, barriers that GAO has identified. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The DEA Administrator should develop and implement additional ways to use algorithms in analyzing ARCOS and other data to more proactively identify problematic drug transaction patterns. (Recommendation 1)

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

Comments: DOJ agreed with this recommendation and DEA stated it will continue to examine a variety of technologies to analyze ARCOS and other data and implement additional ways to use algorithms to more proactively identify problematic drug transaction patterns.

Recommendation: The DEA Administrator, in coordination with the department-wide efforts on data strategy, should establish and document a data governance structure to ensure DEA is maximizing its management of industry-reported drug transaction data. (Recommendation 2)

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

Comments: DOJ agreed with this recommendation. As of September 2019, DEA officials stated that its Office of Information Systems' Chief Data Officer just recently started to work with DOJ and other components to develop a data strategy in response to the recently released department wide strategy, and has begun efforts to develop a governance structure. In November, 2019 DEA indicated it will continue to mature its data governance structure. The intent of this recommendation is for DEA to establish a formalized data governance structure to manage its collection and use of data used to support the Diversion Control Division's mission.

Recommendation: The DEA Administrator should establish outcome-oriented goals and associated measurable performance targets related to opioid diversion activities, using data it collects, to assess how the data it obtains and uses supports its diversion control activities. (Recommendation 3)

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

Comments: DOJ neither agreed nor disagreed with this recommendation but DEA stated in November 2019, that it recognizes that measurable performance targets related to opioid diversion activities can serve as leading practices at different organizational levels including the program, project, or activity level. Our recommendation is intended to ensure that DEA can demonstrate the usefulness of the data it collects and uses to support its opioid diversion control activities.

Recommendation: The DEA Administrator, in consultation with industry stakeholders, should identify solutions to address the limitations of the ARCOS Enhanced Lookup Buyer Statistic Tool, to ensure registrants have the most useful information possible to assist them in identifying and reporting suspicious orders to DEA. (Recommendation 4)

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

Comments: DOJ agreed with this recommendation and in November 2019, stated it has consulted with industry stakeholders and identified solutions to address the limitations of the tool.

Recommendation: The Commissioner of Internal Revenue should assess options for updating Publications 590-A and 590-B to either include more information or direct taxpayers to other resources for IRA owners with investments in unconventional assets. Such information could include: storage requirements for IRA investments in certain precious metals; valuation methods for hard-to-value IRA assets; the Department of Labor's process for granting exemptions to IRA prohibited transactions rules; and IRA investments with the potential to create unrelated business income tax liabilities. (Recommendation 1)

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

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

Recommendation: The Commissioner of Internal Revenue, building on forthcoming compliance research using new IRA asset data, should evaluate the feasibility of requiring disclosure for high-risk IRA asset types associated with abusive schemes as transactions of interest. (Recommendation 2)

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

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

Recommendation: The Commissioner of Internal Revenue should develop resources (such as training materials or job aids) for Small Business/Self-Employed examiners conducting IRA owner audits that explain how IRAs with unconventional assets can generate unrelated business income tax liability, and how examiners can refer cases to unrelated business income experts in IRS for assistance. (Recommendation 3)

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

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

Recommendation: The Administrator of CMS should ensure that state Medicaid programs have written policies and procedures that specify the extent to which covered entities can use 340B drugs for Medicaid beneficiaries, are designed to effectively identify if 340B drugs were used, and if so, how they should be excluded from Medicaid rebate requests. The policies and procedures should be made publically available and cover FFS, managed care, and all of the dispensing methods for outpatient drugs. (Recommendation 1)

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

Comments: HHS concurred with this recommendation and in August 2020 stated that it is developing guidance to state Medicaid programs directing them to strengthen policies and procedures related to 340B drugs for Medicaid beneficiaries.

Recommendation: The Administrator of HRSA should incorporate assessments of covered entities' compliance with state Medicaid programs' policies and procedures regarding the use and identification of 340B drugs into its audit process, working with CMS as needed to obtain states' policies and procedures. (Recommendation 2)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS did not concur with this recommendation and, as of August 2020, did not plan to take any actions to implement the recommendation. As noted in our report, covered entities' compliance with state Medicaid programs' policies and procedures is fundamental to preventing duplicate discounts. Thus, we continue to believe that HRSA's audit process should include an assessment of covered entities' compliance with state Medicaid programs' policies and procedures related to 340B drugs as it is necessary to identify potential duplicate discounts and to ensure covered entities' compliance with 340B Program requirements.

Recommendation: The Administrator of HRSA should require covered entities to work with affected drug manufacturers regarding repayment of identified duplicate discounts in Medicaid managed care. (Recommendation 3)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS did not concur with this recommendation and, as of August 2020, did not plan to take any actions to implement the recommendation. As noted in our report, HRSA officials told us that covered entities' obligations for preventing duplicate discounts are the same for Medicaid fee-for-service and managed care. Thus, we continue to believe that when duplicate discounts related to Medicaid managed care have been identified, the agency should require covered entities to work with manufacturers to remedy them as they do for duplicate discounts related to Medicaid fee-for-service to help ensure compliance with 340B Program requirements.

Recommendation: The Commissioner of the Social Security Administration should clarify policies and procedures to remind staff that a diagnosis of a substance use disorder is not necessary to conduct a Drug Addiction and Alcoholism evaluation. (Recommendation 1)

Agency: Social Security Administration
Status: Open

Comments: SSA agreed with this recommendation. The agency stated that it had revised related policies in February 2020, and had planned to issue guidance and video-on-demand training to further clarify policies and procedures in this area. However, SSA said its efforts to maintain mission critical activities amid the COVID-19 pandemic have delayed further implementation of this recommendation and a specific implementation date could not be provided at this time.

Recommendation: The Commissioner of the Social Security Administration should ensure that staff document their rationale for decisions involving the Drug Addiction and Alcoholism evaluation process. (Recommendation 2)

Agency: Social Security Administration
Status: Open

Comments: SSA agreed with this recommendation. The agency said it had planned to issue guidance reinforcing its policy on properly documenting decisions involving the Drug Addiction and Alcoholism evaluation process. However, SSA said its efforts to maintain mission critical activities amid the COVID-19 pandemic have delayed implementation of this recommendation and a specific implementation date could not be provided at this time.

Recommendation: The Commissioner of FDA should take additional steps to address inconsistency in its written comments to generic drug applicants—including the clarity of writing and the content of comments—among reviewers, such as requiring additional training for reviewers. (Recommendation 1)

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

Comments: FDA concurred with this recommendation and is taking steps to implement it. As of August 2020, FDA stated that it is evaluating methods to improve the clarity and content of primary reviewer comments by developing and providing training and work aids on written communication to ensure that FDA conveys deficiency comments in a clear and consistent manner to applicants. FDA noted that best practices on ensuring consistency in deficiency comments will be shared with primary reviewers. In addition, FDA stated that the agency is reviewing current training and providing coaching for secondary reviewers to exchange, compare, discuss, and improve the content and consistency of common deficiencies communicated in primary reviewer comments.

Recommendation: The Commissioner of FDA should assess the extent to which the timing of brand-name drug companies' drug labeling changes affect the approval of generic drug applications in the first review cycle, and take steps, as appropriate, to limit the effect of brand-name drug labeling changes on pending generic drug applications. (Recommendation 2)

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

Comments: FDA concurred with this recommendation and is taking steps to implement it. As of August 2020, FDA reported that it is identifying and assessing examples of applications in which the brand-name drug company submitted a supplemental application for a labeling change that impacted the timeline of the generic drug approval. After gathering data, FDA officials stated that they will assess what particular actions could address this issue, including whether FDA has the authority to take any such identified actions.

Recommendation: The Director of JIATF-West should establish a vital few performance measures that are consistently measured over time. (Recommendation 1)

Agency: Joint Interagency Task Force West
Status: Open

Comments: In November 2019, DOD officials reported that JIATF-W identified measures of performance in critical mission areas that have not previously been captured, including the Counter Narcotics Operations Center, Operational Intelligence, and Mission Support units. However, it is unclear whether the measures JIATF-W identified are higher-level and part of a "vital few" rather than just additional output-based performance measures. GAO will need to review the new measures to understand whether DOD/JIATF-W's actions are aligned with the intent of the recommendation. GAO will continue to follow-up with DOD/JIATF-W on the their progress toward implementing the recommendation.

Recommendation: The Director of JIATF-West should establish specific targets that set a minimal level of performance. (Recommendation 2)

Agency: Joint Interagency Task Force West
Status: Open

Comments: In November 2019, DOD stated JIATF-W updated its Assessment Instruction to codify baseline standards and processes for collecting metrics in its directorates and would send personnel to train to improve their ability to measure performance against DOD minimal standards. However, it is unclear whether JIATF-W has set targets. We will continue to follow up with DOD/JIATF-W on their progress toward implementing the recommendation.

Recommendation: The Secretary of Homeland Security should develop outcome-based performance measures for the DHS JTFs that are consistent. (Recommendation 3)

Agency: Department of Homeland Security
Status: Open

Comments: DHS stated it concurred with the GAO recommendation. In December 2019, DHS officials stated it is overseeing the implementation of measures that contain outcome-based direction for assessing counter drug operations effects, which requires a phased approach, and added that DHS hopes to achieve two consecutive years of consistent reporting of performance measures. The estimated completion date for addressing this recommendation is June 2020. GAO will continue to follow-up with DHS on its progress towards implementing the recommendation.

Recommendation: The Secretary of State should, in consultation with other U.S. agencies involved in counternarcotics efforts in Colombia, conduct an evaluation of the long-term effectiveness of eradication and interdiction in reducing the cocaine supply. (Recommendation 1)

Agency: Department of State
Status: Open

Comments: State generally agreed with our recommendation. As of February 2020, State reported that, working with the Department of Defense, it had signed a contract with RAND for an evaluation of counternarcotics efforts in Colombia. The evaluation will, among other things, asses the effectiveness of U.S. government-funded counternarcotics assistance programs in Colombia from 2000 through 2018. RAND plans to complete the evaluation within 16 months of the contract's execution. We will continue to monitor progress on the evaluation and State's efforts to implement our recommendation.

Recommendation: The Secretary of State should, in consultation with other U.S. agencies involved in counternarcotics efforts in Colombia, undertake a comprehensive review of the U.S. counternarcotics approach in Colombia and identify what changes, if any, should be made to the types and combination of U.S. activities, taking into consideration how the relative benefits and limitations between eradication, interdiction, and alternative development may impact the effectiveness of these efforts. (Recommendation 2)

Agency: Department of State
Status: Open

Comments: State generally agreed with our recommendation. As of February 2020, State reported that, working with the Department of Defense, it had signed a contract with RAND for an evaluation of counternarcotics efforts in Colombia. The evaluation will include, among other things, a comprehensive review of the U.S. counternarcotics approach in Colombia that considers the relative benefits and limitations between eradication, interdiction, and alternative development efforts. RAND plans to complete the evaluation within 16 months of the contract's execution. We will continue to monitor progress on the evaluation and State's efforts to implement our recommendation.

Recommendation: The Administrator of HRSA should require covered entities to register contract pharmacies for each site of the entity for which a contract exists. (Recommendation 1)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS does not concur with this recommendation and, as of July 2020, did not plan to take any actions to implement the recommendation. As noted in our report, without complete information on contract pharmacy arrangements--including information on with sites of a covered entity have contracts with a contract pharmacy--HRSA cannot ensure that it is optimally targeting the limited number of audits done each year. Additionally, manufacturers lack important information to help ensure that 340B discounted drugs are only provided to pharmacies with a valid 340B contract with the covered entity site for which the drug is being dispensed.

Recommendation: The Administrator of HRSA should issue guidance to covered entities on the prevention of duplicate discounts under Medicaid managed care, working with CMS as HRSA deems necessary to coordinate with guidance provided to state Medicaid programs.(Recommendation 2)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open
Priority recommendation

Comments: HHS concurred with this recommendation. In July 2020, HHS indicated that it believes that guidance does not provide HRSA appropriate enforcement capability and that this recommendation can only be accomplished after policy is issued. HRSA has requested regulatory authority for all aspects of the 340B Program in the FY 2021 President's Budget.

Recommendation: The Administrator of HRSA should incorporate an assessment of covered entities' compliance with the prohibition on duplicate discounts, as it relates to Medicaid managed care claims, into its audit process after guidance has been issued and ensure that identified violations are rectified by the entities. (Recommendation 3)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open
Priority recommendation

Comments: HHS concurred with this recommendation. In July 2020, HHS indicated that it believes that guidance does not provide HRSA appropriate enforcement capability and that this recommendation can only be accomplished after policy is issued. HRSA has requested regulatory authority for all aspects of the 340B Program in the FY 2021 President's Budget.

Recommendation: The Administrator of HRSA should issue guidance on the length of time covered entities must look back following an audit to identify the full scope of noncompliance identified during the audit.(Recommendation 4)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS concurred with this recommendation. In July 2020, HHS indicated that it believes that guidance does not provide HRSA appropriate enforcement capability and that this recommendation can only be accomplished after policy is issued. HRSA has requested regulatory authority for all aspects of the 340B Program in the FY 2021 President's Budget.

Recommendation: The Administrator of HRSA should require all covered entities to specify their methodology for identifying the full scope of noncompliance identified during the audit as part of their corrective action plans, and incorporate reviews of the methodology into their audit process to ensure that entities are adequately assessing the full scope of noncompliance. (Recommendation 5)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS does not concur with this recommendation and, as of July 2020, did not plan to take any actions to implement the recommendation. HHS noted that requiring all covered entities subject to an audit to specify their methodology for identifying the full scope of noncompliance identified during the audit would create a significant burden for covered entities. However, as noted in our report, HRSA already requires covered entities with audit findings to determine the full scope of noncompliance and requires entities subject to a targeted audit to provide their methodology for such assessments to HRSA. Thus, it is unclear how requiring covered entities subject to risk-based, as opposed to targeted, audits to provide HRSA with a written description of methodologies that they are already required to formulate and implement would create a significant additional burden. Without this information, HRSA does not have reasonable assurance that the majority of covered entities have adequately identified all instances of noncompliance.

Recommendation: The Administrator of HRSA should require all covered entities to provide evidence that their corrective action plans have been successfully implemented prior to closing audits, including documentation of the results of the entities' assessments of the full scope of noncompliance identified during each audit.(Recommendation 6)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS does not concur with this recommendation and, as of July 2020, did not plan to take any actions to implement the recommendation. HHS stated that requiring all covered entities with audit findings to provide evidence that their corrective action plans have been successfully implemented would create an undue burden for covered entities. However, HRSA already requires such evidence from covered entities subject to targeted audits, and it is unclear how providing evidence of implementation of corrective actions that entities developed and are required to implement would create significant additional burden for these entities. Additionally, without such evidence HRSA does not have a reasonable assurance that the majority of covered entities audited have corrected the issues identified in the audit, and are not continuing practices that could lead to noncompliance.

Recommendation: The Administrator of HRSA should provide more specific guidance to covered entities regarding contract pharmacy oversight, including the scope and frequency of such oversight. (Recommendation 7)

Agency: Department of Health and Human Services: Public Health Service: Health Resources and Services Administration
Status: Open

Comments: HHS concurred with this recommendation. In July 2020, HHS indicated that it believes that guidance does not provide HRSA appropriate enforcement capability and that this recommendation can only be accomplished after policy is issued. HRSA has requested regulatory authority for all aspects of the 340B Program in the FY 2021 President's Budget.

Recommendation: The Director of ONDCP, in collaboration with law enforcement and public health counterparts, should lead a review on ways to improve the timeliness, accuracy, and accessibility of fatal and non-fatal overdose data from law enforcement and public health sources that provide critical information to understand and respond to the opioid epidemic. Such a review should expand on and leverage the findings from previous federal studies. It should also assess the benefits and scalability of ongoing efforts to leverage data systems, such as the Washington-Baltimore High-Intensity Drug Trafficking Areas' (HIDTA) OD MAP program, and examine ways in which laws that restrict access to public health data to protect patient privacy have exemptions for law enforcement entities that could be more widely leveraged while protecting patient privacy. (Recommendation 2)

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

Comments: In the 60-day letter, dated June 28, 2018, ONDCP officials noted a number of federal initiatives underway to evaluate the timeliness, accuracy, and accessibility of overdose data. For example, ONDCP discussed its participation in a new Interagency Working Group led by the National Security Council to consider the implementation of overdose tracking and analytic capability, such as the expansion of ODMAP, as well as evaluating the appropriate federal role to engage in this initiative. In March 2019, ONDCP reported that it had suspended its ODMAP working group in the summer of 2018, after determining that this effort would be more effective for the Department of Justice's Bureau of Justice Assistance (BJA) and the Centers for Disease Control and Prevention (CDC) to work together through the Comprehensive Opioid Abuse Program Initiative. Nevertheless, as of April 2019, ONDCP officials reported that they continue to provide grant funding and training and technical assistance towards the expansion and use of ODMAP by state and local jurisdictions. Further, ONDCP reported supporting other federal data initiatives, such as providing funding to develop software for the CDC's National Center for Health Statistics Mortality Data that could better read narrative fields in death certificates to improve the timeliness and accuracy of the data. While ONDCP's efforts are directed towards supporting and improving existing data sources, the recommendation asks ONDCP to lead a review which it has not done. Further, ONDCP's initiatives to date have not addressed issues raised in our report related to balancing law enforcement's access to restricted health data while protecting patient privacy. We will continue to monitor ONDCP's efforts towards implementing this recommendation.

Recommendation: The Director of ONDCP should work with the HIDTAs participating in the Heroin Response Strategy to establish outcome-oriented performance measures for the four main goals set out in the strategy. (Recommendation 3)

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

Comments: In the 60-day letter, dated June 28, 2018, ONDCP officials stated that they had engaged with leaders from HIDTA participating in the Heroin Response Strategy to develop performance measures. According to ONDCP, as of early May 2018, eleven performance measures had been established--nine mandatory measures and two optional measures--and four of these measures constitute outcome-oriented measures. The June letter also noted that the HIDTA Performance Management Process database was being updated to reflect the new measures and ONDCP expected the system to be fully operational by the end of September 2018. In March 2019, ONDCP reported that, throughout the summer of 2018, it had revisited the performance measures it had developed and settled on ten revised performance measures (eight mandatory measures and two optional measures) for the newly branded Opioid Response Strategy (formerly known as the Heroin Response Strategy). According to ONDCP, these measures were implemented in HIDTA's Performance Management Process as of February 1, 2019. We will continue to coordinate with ONDCP to obtain documentation of these new measures. Once we obtain them, we will review and work toward closing the recommendation, as appropriate.

Recommendation: The Executive Director of Organized Crime Drug Enforcement Task Forces should work with the National Heroin Initiative Coordinator to establish outcome-oriented performance measures for the goals set out for National Heroin Initiative. (Recommendation 4)

Agency: Department of Justice: Organized Crime Drug Enforcement Task Forces
Status: Open
Priority recommendation

Comments: In its 60 Day-letter, dated June 26, 2018, officials from the Organized Crime Drug Enforcement Task Force (OCDETF) noted the output metrics and statistics that OCDETF is tracking as part of its National Heroin Initiative. For example, the letter states that OCDETF will track statistics on opioid overdose deaths, however it is unclear how this tracking effort is being incorporated into the National Heroin Initiative. While our report noted that statistics on overdose deaths have been used as outcome-oriented measures by agencies like the Office of National Drug Control Policy to assess its efforts, it is unclear how OCDETF is using these statistics to assess its performance and inform its efforts under the National Heroin Initiative. In October 2018, OCDETFs National Heroin Initiative Coordinator told us that the OCDETF Regional Directors were in the process of establishing and tracking region-specific metrics, such as local data on drug overdoses. In January 2020, we reached out to OCEDTF officials for an update, and they did not have any further information to provide. In August 2020, OCDETF officials told us that the National Heroin Initiative had evolved and they are no longer positioned to collect and report on drug overdoses as a performance measure for the initiative. However, officials stated that the initiative is measuring the number of OCDETF cases that are produced that result in the disruption or dismantlement of criminal networks involved in heroin and opioid trafficking. We asked OCDETF to provide documentation of the current state of the initiative and its related goals and performance measures. Once received, we will review and follow-up with OCDETF, if needed, to work towards the closure of the recommendation as implemented.

Recommendation: The Attorney General should, in consultation with its relevant components such as the Drug Enforcement Administration (DEA) and Executive Office for United States Attorneys (EOUSA), establish goals and outcome oriented performance measures for its Strategy to Combat the Opioid Epidemic. (Recommendation 5)

Agency: Department of Justice
Status: Open
Priority recommendation

Comments: In its 60 Day-letter, dated June 26, 2018, DOJ officials reported a number of output measures, such as conviction rates, that they will use to assess the effectiveness of the department's efforts to respond to the opioid epidemic. However, it is unclear how, if all, these measures have been incorporated into the department-wide strategy or if additional outcome-oriented metrics are being developed. In October 2018, DOJ officials reported that while they have not updated the strategy, then-Attorney General Sessions had issued a memo to the U.S. Attorneys that communicated some goals for their efforts, such as reductions in overdose deaths, and called for the U.S. Attorneys Office's Regional Opioid Coordinators to develop metrics specific to their regions. In October 2019, DOJ officials reported that the department is currently working on finalizing its Annual Priority Goals and related performance measures with respect to opioids, however they could not provide additional details nor a timeline for when these efforts are to be completed. We reached out in January 2020 to receive additional details and the Department did not have any further information to provide. We will continue to coordinate with DOJ to learn more about these efforts and when officials expect them to be implemented.

Recommendation: The DEA Administrator should establish goals and outcome-oriented performance measures for the enforcement and diversion control activities within the 360 Strategy and establish outcome-oriented performance measures for the community engagement activities within the 360 Strategy. (Recommendation 6)

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

Comments: In its 60-Day Letter, dated June 26, 2018, DEA officials noted the steps they had taken to develop performance metrics for its enforcement and diversion control activities under the 360 Strategy and reported that DEA had implemented outcome-oriented performance metrics for the 360 Strategy's community engagement activities for fiscal year 2019. Further, DEA officials noted applying DEA's Threat Enforcement Planning Process (TEPP) specifically to the 360 Strategy to develop outcome-oriented metrics. Further, according to DEA officials, the TEPP includes an impact report that assesses the outcomes of the activities undertaken under 360. In October 2018, DEA told us that TEPP was still in development and they did not give a date for projected completion. In January 2020, we reached out to DEA officials for an update, and they did not have any further information to provide. We will continue to follow up with DEA officials on their progress.

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: HHS did not concur with this recommendation. As of September 2019, HHS had not provided information on actions taken to implement it. We will update its status when we receive additional information.

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
Priority recommendation

Comments: HHS concurred with this recommendation. HHS' Behavioral Health Coordinating Council finalized a plan for implementing the Strategy in 2019 . The plan includes priorities, timeframes, and clear roles and responsibilities for implementing NAS-related recommendations in the Strategy. The plan does not specifically identify methods for assessing progress on the recommendations, but HHS officials told us in November 2019 that the department holds quarterly conference calls to share updates and formal written updates will be collected at the end of each year. To close this recommendation, HHS needs to provide documentation-such as, the formal written updates-to show how the department assesses progress on the recommendations.

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: In June and July 2018 FDA reported on its recent efforts to assess the effectiveness of the foreign offices' contributions to drug-safety related outcomes. These efforts include the development of new performance measures for these offices along with a monitoring and evaluation plan; strengthened communications and collaboration between the foreign offices and FDA program centers and its Office of Regulatory Affairs; and an assessment of the foreign offices to help set their objectives and ensure the right balance of personnel, skillsets, and resources. However, FDA still had to develop intermediate outcomes to link with final outcomes. In an August 2020 written response, the agency reported that because of a reorganization and strategic planning effort for its Office of Global Policy and Strategy, it was still revising and updating its measures and its approach to evaluating impact in 2020 to align with a five-year strategic plan completed in March 2020. The agency indicated that the recommendation should remain open, and GAO will continue to monitor the implementation of this recommendation.

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 June 2020, 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 September 2018, HHS officials reiterated that they believe the agency has addressed our recommendation because CMS works with HHS's Office of Inspector General (OIG) as appropriate to collect source documentation from drug manufacturers and takes action as warranted. HHS stated that CMS has continued to provide information regarding problematic ASP submissions to OIG for evaluation of misreporting and continues to use AMP and other benchmarks as comparisons for pricing determinations. They further stated that they do not believe that additional collection of detailed sales information about ASP, such as invoices, is authorized under Part B drug payment provisions in section 1847A or under section 1927(b). As of June 2020, CMS did not provide any additional updates. While we recognize that CMS conducts routine checks to assess the completeness of ASP data submitted by drug manufacturers, we do not believe these activities are enough to close the recommendation. Specifically, 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 verify the accuracy of ASP data for a sample of manufacturers by tracing the data to and from drug manufacturers' source documents, such as sales invoices. Because CMS does not routinely verify the accuracy of the underlying data used to determine Medicare payment rates, the resulting payment rates may be inaccurate if drug manufacturers do not report accurate data. With regards to CMS's authority to collect additional information, such as invoices, we believe the agency could work through OIG to collect such information.

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 April 2018, DEA told us that it assessed the feasibility of directly collaborating with SSA to check registrants' SSNs against any SSA systems, including the Enumeration Verification System (EVS), and is unable to implement a data verification process to validate SSNs against EVS without legislative authority. Specifically, DEA said that access to SSA's systems would require passage of new legislation to authorize DEA to fully participate in a data exchange agreement with SSA, which DEA said was also confirmed by Senate staff. In June 2020, DEA provided documentation of SSA's response to DEA's request to access EVS which stated that SSA was unable to enter into a data exchange under the conditions DEA initially proposed. However, it also stated that SSA would explore granting DEA access if DEA requested number-holder's consent. Therefore, we continue to believe there is a possible path forward in using SSA's service. Additionally, DEA told us that it would use information from the Federation of State Medical Boards (FSMB) to validate SSNs. However, as of August 2020, DEA has not provided any documentation to support how or if this has been implemented. Further, as noted in our report, FSMB is limited to information for medical doctors, osteopathic doctors and some physician assistants, which make up only a portion of DEA's registrants. As we noted in our report, validating SSNs will help establish registrants' identities which will better ensure DEA has the information necessary to implement its existing controls and to identify other registrations held by each individual, including past adverse actions taken against previous registrations. As such, we continue to believe that DEA should take steps to validate the information it receives. We will continue to monitor the agency's progress in this area.

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 July 2018, DEA provided a copy of its purchase order award to the Federation of State Medical Boards (FSMB); however, as of August 2020, DEA has not provided documentation to demonstrate how use of FSMB will be implemented. Also, in April 2018, DEA said it was exploring how to establish a cost-effective system to obtain National Practitioner Data Bank (NPDB) information and will reevaluate the need to obtain NPDB information after DEA has had the opportunity to process the FSMB information. In June 2020, DEA stated it will not be taking additional action on obtaining NPDB. We will continue to monitor DEA's progress in implementing this recommendation.

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: FDA concurred with the recommendation and in September 2016 and January 2018 described steps it had taken toward strategic planning for its medical product centers. However, in June 2020, FDA informed GAO that there had been several senior leadership changes and its agency-wide strategic planning process was paused to focus on the covid-19 pandemic response. Officials also noted that FDA continues to address existing strategic priorities. We will update the status of this recommendation when we receive additional information.

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 made changes intended to improve its process for overseeing tracked safety issues, but as of August 2020, FDA was still working on changes to its process for postmarket study data. For tracked safety issues, FDA held a one-day workshop to solicit input from staff on changes to its tracked safety issue process and collect user requirements for a new IT system to support tracking safety issues. In April 2020, FDA finalized new policies and procedures and implemented a new IT system for tracking safety issues. The new IT system allows anyone within FDA's Center for Drug Evaluation and Research to enter new safety signals and has integrated product and adverse event dictionaries. FDA stated that integrating standardized data will support consistent regulatory decisions and improve the quality of analysis. For postmarket studies, FDA has indicated that it intends to formally assess the IT needs of users as part of the planned transfer of postmarket data to its new informatics platform. As of August 2020, FDA anticipated creating a project team to address specific concerns related to postmarket study data by the end of calendar year 2020 or the beginning of calendar year 2021. GAO is keeping this recommendation open until FDA has completed its planned improvements to its process for tracking postmarket study data.

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 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 June 2020, Congress had not acted on this Matter for Congressional Consideration.

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: We requested an update from ONDCP on the status of its efforts to implement this recommendation. As of August, 2018, 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: We requested an update from ONDCP on the status of its efforts to implement this recommendation. As of August, 2018, 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: We requested an update from ONDCP on the status of its efforts to implement this recommendation. As of August, 2018, we have not received a response. We will update the status of this recommendation when we receive additional information.

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. In March 2018, HRSA told GAO that it continues to assess next steps with the Administration on the proposed omnibus guidance, which included the patient definition. In June 2019, HRSA reported that it is still working with the Department to determine next steps for this recommendation. In July 2020, HRSA reported that it conducted an evaluation of its audit process and other program integrity efforts and determined that guidance does not provide the agency with appropriate enforcement capability. Therefore, HRSA is not pursing new guidance under the Program at this time. The FY 2021 President's Budget includes a proposal to provide HRSA comprehensive regulatory authority.

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. In March 2018, HRSA reported that it believes it is unable to implement this recommendation without additional legislative authority because the statute does not speak to the issue raised in the recommendation. HRSA also noted that the FY19 President's Budget includes a proposal to provide HRSA comprehensive regulatory authority, and that if this proposal is enacted, it could regulate on hospital eligibility. In June 2019, HRSA reported that it is still unable to implement this recommendation without additional legislative authority, though the President's FY 2020 Budget includes a proposal to provide HRSA with such authority. In July 2020, HRSA reported that it conducted an evaluation of its audit process and other program integrity efforts and determined that guidance does not provide the agency with appropriate enforcement capability. Therefore, HRSA is not pursing new guidance under the Program at this time. The FY 2021 President's Budget includes a proposal to provide HRSA comprehensive regulatory authority.

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.