Recommendation: The Commissioner of FDA should establish and implement formal policies to use quality information (e.g., linking decisions to mission-related goals) in the three centers' planning for their personal property needs, consistent with key characteristics integral to asset management leading practices. (Recommendation 1)

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

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

Recommendation: The Commissioner of FDA should establish and implement formal policies to use quality information (e.g., tracking condition, and maintenance and repair costs) in the three centers' operations and maintenance of personal property, consistent with key characteristics integral to asset management leading practices. (Recommendation 2)

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

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

Recommendation: The Commissioner of FDA should establish and implement formal policies to use quality information (e.g., measuring and documenting performance) in the three centers' reviews of personal property performance, consistent with key characteristics integral to asset management leading practices. (Recommendation 3)

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

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

Recommendation: The Administrator of GSA should take steps to ensure that the condition of all White Oak facilities that FDA occupies are assessed, including limited access areas and tenant improvements that are above the standard services and facilities that GSA provides. (Recommendation 4)

Agency: General Services Administration
Status: Open

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

Recommendation: The 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 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 determine the extent to which state Medicaid programs are in compliance with federal requirements to cover MAT medications in all formats and take actions to ensure compliance, as appropriate. (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 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 Director of ONDCP should develop and document key planning elements to help the agency meet the SUPPORT Act requirements for the 2020 National Drug Control Strategy and future Strategy iterations. These planning elements should include descriptions of resource investments, time frames, and any processes, policies, roles, and responsibilities needed to address each requirement. (Recommendation 1)

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

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

Recommendation: The Director of ONDCP should—after developing and documenting key planning elements to meet the SUPPORT Act requirements—routinely implement an approach, based on these planning elements, to meet the requirements for the 2020 National Drug Control Strategy and future Strategy iterations. (Recommendation 2)

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

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

Recommendation: The Director of ONDCP should develop and document key planning elements to help the agency meet the SUPPORT Act requirements to establish a Drug Control Data Dashboard that would include descriptions of resource investments, time frames, and any processes, policies, or roles, and responsibilities needed to address this requirement. (Recommendation 3)

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

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

Recommendation: The Director of ONDCP should—after developing and documenting key planning elements—implement an approach, based on these planning elements, to meet the SUPPORT Act requirements to establish a Drug Control Data Dashboard. (Recommendation 4)

Agency: Executive Office of the President: Office of National Drug Control Policy
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 HRSA should ensure that the information it uses to verify nonprofit status for all nongovernmental hospitals that participate in the 340B Program is reliable—for example, by requiring and reviewing the submission of official documentation hospitals must already maintain or by ensuring the reliability of the data the agency uses. (Recommendation 1)

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

Comments: HHS concurred with this recommendation and in June 2020, reiterated that HRSA believes that the information it uses to determine nonprofit status is reliable, because hospital administrators attest to its accuracy. However, as discussed in our report, neither HRSA nor the agency that collects the data has evaluated the reliability of the data for verifying nonprofit status. Without ensuring it is using reliable information, HRSA cannot effectively determine if nongovernmental hospitals participating, or seeking to participate, in the 340B Program meet the statutory eligibility requirements.

Recommendation: The Administrator of HRSA should implement a process to verify that every nongovernmental hospital that participates in the 340B Program has a contract with a state or local government as required by statute. (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 June 2, 2020, did not plan to take any actions to implement the recommendation. HHS noted that requiring all covered entities to submit a state or local government contract would create a significant burden for covered entities. However, as we noted in our report, HRSA already requires hospitals to maintain copies of their state or local government contracts. Therefore, it is unclear how implementing a process to verify the existence of those contracts would represent a significant burden. Without this information, HRSA does not have reasonable assurance that nongovernmental hospitals have the statutorily required contracts to participate in the 340B Program.

Recommendation: The Administrator of HRSA should provide more specific guidance for 340B Program auditors on how to determine if nongovernmental hospitals' contracts with state and local governments require the provision of health care services to low-income individuals not eligible for Medicaid or Medicare. (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 and in June 2020, indicated that HRSA had updated its audit guidance and procedures to more clearly specify that contracts must contain requirements for the provision of health care services to low-income individuals. However, these documents do not contain any specific guidance on how auditors are to evaluate whether contracts require these services. Without more specific guidance for auditors' review of contracts, HRSA lacks reasonable assurance that the audits are appropriately identifying deficiencies in nongovernmental hospitals' contracts with state or local governments.

Recommendation: The Administrator of HRSA should require nongovernmental hospitals participating in the 340B Program to demonstrate that they have contracts with state or local governments in effect prior to the beginning of their audits' periods of review and should apply consistent and appropriate consequences for hospitals that are unable to do so. (Recommendation 6)

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

Comments: HHS concurred with this recommendation. As noted in our report, HRSA updated its draft audit procedures for fiscal year 2020 audits in September 2019 to specify that auditors should look for effective dates that cover the entire audit period. While this is an important step, HRSA must also show that it has ceased accepting retroactive contract documentation, and has applied consistent and appropriate consequences when auditors find that nongovernmental hospitals did not have contracts in effect prior to the beginning of their audit periods. As of June 2020, HHS indicated that HRSA had not taken these actions. Allowing hospitals that are unable to demonstrate that they have contracts in place that cover their audits' periods of review to continue to participate without consequences undermines the effectiveness of HRSA's audit process and increases the risk that ineligible hospitals will receive discounts under the program.

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 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 Undersecretary for Health should ensure that Central Office, Veterans Integrated Service Networks (VISN), and medical facilities document the actions they take towards achieving OSI goals. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open

Comments: VA concurred with the recommendation. To fully implement this recommendation, VHA needs to provide information about the new documentation requirements described in the November 2019 update.

Recommendation: The Undersecretary for Health should ensure that any OSI goals that have not been met have clearly defined, measurable outcomes, including milestones or numerical targets, as appropriate, and timeframes. (Recommendation 2)

Agency: Department of Veterans Affairs
Status: Open

Comments: VA concurred with the recommendation. To fully implement this recommendation, VHA needs to provide information about specific actions, described in the November 2019 update, taken to address the recommendation including documentation showing the actions taken to review the OSI goals and documentation of new OSI goals, metrics, and timelines.

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

Agency: Department of Veterans Affairs
Status: Open

Comments: VA concurred with our recommendation and in August 2017 stated that it had identified $4 million in fiscal year 2018 to establish a pharmacy graphical user interface. As of September 2020, VA was still in the process of implementing the pharmacy graphical user interface, which it estimated it would deploy in December 2020. We will continue to monitor the situation.

Recommendation: To provide clinicians and pharmacists with improved tools to support pharmacy services to veterans and reduce risks to patient safety, the Secretary of Veterans Affairs should direct the Assistant Secretary for Information and Technology and the Under Secretary for Health to complete a plan for the implementation of an approach to data standardization that will support the capability for clinicians and pharmacists to view complete DOD data and receive order checks that consistently include DOD data.

Agency: Department of Veterans Affairs
Status: Open

Comments: VA concurred in principle with our recommendation and in May 2018 awarded a contract to implement the same electronic health record system that is being deployed by DOD, which is intended to present VA clinicians with complete DOD data and the ability to perform order checks on DOD data. In parallel, the department is continuing and expanding the implementation of data standardization. According to the department's September 2020 update, the agency had updated its pharmacy system to improve data standardization. However, the agency had not submitted sufficient documentation to close the recommendation. We will continue to monitor the situation.

Recommendation: To provide clinicians and pharmacists with improved tools to support pharmacy services to veterans and reduce risks to patient safety, the Secretary of Veterans Affairs should direct the Assistant Secretary for Information and Technology and the Under Secretary for Health to conduct an assessment to determine to what extent interoperability of VA's pharmacy system with DOD's pharmacy system is impacting transitioning service members.

Agency: Department of Veterans Affairs
Status: Open

Comments: VA concurred with our recommendation and in May 2017 stated that the health executive committee would complete an assessment to determine the extent interoperability with DOD's pharmacy system is impacting transitioning service members. In October 2017, VA conducted an assessment, however it was limited to one part of its system, the Joint Legacy Viewer (JLV), and read-only data. In September 2020, the agency provided a written response to supplement its October 2017 assessment with additional data regarding the potential impact of failures of its system to exchange pharmacy and allergy data with DOD. However, VA had not submitted sufficient documentation to close the recommendation. We will continue to monitor the situation.

Recommendation: To provide clinicians and pharmacists with improved tools to support pharmacy services to veterans and reduce risks to patient safety, the Secretary of Veterans Affairs should direct the Assistant Secretary for Information and Technology and the Under Secretary for Health to develop and execute a plan for implementing the capability to send outbound e-prescriptions to non-VA pharmacies, in accordance with National Council for Prescription Drug Programs standards.

Agency: Department of Veterans Affairs
Status: Open

Comments: VA concurred with our recommendation and in August 2017 stated that it will review its plan for e-prescribing functionality after it has signed a contract to adopt the electronic health record system that is being deployed by DOD. Although VA awarded the contract for the new electronic health record system in May 2018, VA had not submitted sufficient documentation to close the recommendation as of September 2020. We will continue to monitor the situation.

Recommendation: To provide clinicians and pharmacists with improved tools to support pharmacy services to veterans and reduce risks to patient safety, the Secretary of Veterans Affairs should direct the Assistant Secretary for Information and Technology and the Under Secretary for Health to ensure that the department's evaluation of alternatives for electronic health records includes consideration for additional generation level 3 capability such as navigating from an alert to medication order in the electronic health record system.

Agency: Department of Veterans Affairs
Status: Open

Comments: VA concurred with our recommendation and in August 2017 stated that it had entered into contract negotiations to acquire and deploy a level 3 electronic health record system that is expected to address pharmacy functions. As of September 2020, the agency had not submitted sufficient documentation to close the recommendation. We will update the status of this recommendation when VA provides documentation of its evaluation of alternatives to us.

Recommendation: To provide clinicians and pharmacists with improved tools to support pharmacy services to veterans and reduce risks to patient safety, the Secretary of Veterans Affairs should direct the Assistant Secretary for Information and Technology and the Under Secretary for Health to reassess the priority for establishing an inventory management capability to monitor and update medication levels and track when to reorder medications.

Agency: Department of Veterans Affairs
Status: Open

Comments: VA concurred with our recommendation and in August 2017 stated that it will reassess the prioritization of medication inventory management after a contract for adoption of the electronic health record system is signed. As of September 2020, VA had not submitted sufficient documentation to close the recommendation. We will continue to monitor the situation.

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: As of August 2020, Congress had not passed legislation to address this Matter for Congressional Consideration. We will update the status of this Matter if such action occurs.

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

Agency: Department of Defense
Status: Open

Comments: DOD concurred with this recommendation and stated that any policy that it may issue related to the monitoring of prescribing practices would be directed toward all of the military services. In May 2018 DOD stated that it planned to (1) conduct a comprehensive review of existing prescribing practices for the treatment of PTSD; (2) develop policy guidance for addressing prescribing practices for the management of PTSD that deviate from the clinical practice guideline; and (3) implement an automated dashboard that will flag medications that the PTSD guideline discourages from use. In its February 26, 2020 response, DOD stated that July 30, 2020 is the estimated completion date for these planned actions. To close this recommendation, DOD needs to implement its planned actions and provide documentation showing that the Department is monitoring medications discouraged from use under the PTSD guideline and addressing identified deviations.

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: In order to strengthen DEA's communication with and guidance for registrants and associations representing registrants, as well as supporting the Office of Diversion Control's mission of preventing diversion while ensuring an adequate and uninterrupted supply of controlled substances for legitimate medical needs, the Deputy Assistant Administrator for the Office of Diversion Control should solicit input from distributors, or associations representing distributors, and develop additional guidance for distributors regarding their roles and responsibilities for suspicious orders monitoring and reporting.

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

Comments: In September 2019, DEA told us that the agency had refocused its efforts on revising draft regulations in line with the SUPPORT for Patients and Communities Act, and that the revised draft was undergoing internal DEA and Department of Justice review. The agency noted that it expected the rule to codify existing legal obligations related to due diligence and suspicious order reporting and provide additional guidance regarding the nature and timing of the suspicious order reporting requirement, but also indicated that it was not possible to be certain of the precise nature of the draft rule. While DEA has reported taking some actions to address this recommendation, as noted above, until the regulations are finalized we cannot determine if these changes will fully address the recommendation. We will continue to monitor DEA's progress in addressing our recommendation.

Recommendation: In order to strengthen DEA's communication with and guidance for registrants and associations representing registrants, as well as supporting the Office of Diversion Control's mission of preventing diversion while ensuring an adequate and uninterrupted supply of controlled substances for legitimate medical needs, the Deputy Assistant Administrator for the Office of Diversion Control should solicit input from pharmacists, or associations representing pharmacies and pharmacists, about updates and additions needed to existing guidance for pharmacists, and revise or issue guidance accordingly.

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

Comments: In April 2016, DEA reported that it had worked with the National Association of Boards of Pharmacy regarding issues raised during stakeholder discussions, which resulted in a March 2015 consensus document published by stakeholders entitled "Stakeholders' Challenges and Red Flag Warning Signs Related to Prescribing and Dispensing Controlled Substances." Additionally, in December 2016 DEA also described other ways in which the agency had been working with pharmacists or associations representing pharmacists to discuss their responsibilities, such as during regional one-day Pharmacy Diversion Awareness Conferences, and quarterly meetings with two pharmacy associations. In February 2018, DEA reported that following input from pharmacists, and representatives of pharmacies and pharmacists, it had revised its existing Pharmacist's Manual. DEA reported in September 2019 that the manual was currently in the final approval process for publication, and that when published, DEA would provide the manual to GAO. Until the updated Pharmacist's Manual is published and we have a chance to review the revisions, we cannot fully assess DEA's actions in this area. Therefore, the recommendation remains open.

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: 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 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 September 2018, FDA told us that it was using its drug shortage data system, the "Shortage Tracker," to summarize information reported by manufacturers as the reasons for existing shortages. The agency indicated that it was developing a model that would factor in drug shortage data, warning signs identified through social media, and other factors to help identify early indicators that may predict future shortages. In July 2019, the agency indicated it could conduct periodic analyses of the causes of drug shortages. However, FDA had not yet proactively conducted any rigorous analyses of predictors of drug shortages to help recognize trends, clarify causes, and resolve problems before drugs go into short supply. In an August 2020 written response, FDA reported that it was undertaking modeling efforts to explore the feasibility of predicting future drug shortages using machine learning approaches. FDA planned to complete the initial modeling by fall 2020, at which time it would identify next steps. The agency indicated that the recommendation should remain open, and GAO will continue to monitor the implementation of this recommendation.

Recommendation: To help ensure the success of FDA's modernization efforts, the Commissioner of FDA should direct the CIO to, in completing the assessment of Mission Accomplishments and Regulatory Compliance Services (MARCS), develop an integrated master schedule (IMS) that (1) identifies which legacy systems will be replaced and when; (2) identifies all current and future tasks to be performed by contractors and FDA; and (3) defines and incorporates information reflecting resources and critical dependencies.

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

Comments: In 2018, we confirmed that FDA, in response to our recommendation, began efforts to identify which legacy systems will be replaced. FDA also developed an IMS for fiscal year (FY) 2017 and 2018 that identifies current and future tasks to be performed by contractors and FDA. However, FDA's IMS for FY 2017 and 2018 does not fully and clearly define resources. For example, although the FY 2017 IMS includes 265 names, roles, and teams, only 16 percent of activities have resource assignments. Further, FDA's fiscal year 2018 IMS does not fully define critical dependencies. For example, there are 14 activities and milestones with finish dates that are not properly tied to logic. Specifically, the finish dates of the 14 activities are not clearly tied to succeeding activities in the schedule. We contacted FDA in September and December 2019 and January 2020 for an update on the actions taken to implement the recommendation, but have not received a response. We will update the recommendation when additional information is obtained.

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: 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.

Recommendation: To meet its fiduciary responsibility of ensuring that section 1115 waivers are budget neutral, the Secretary of Health and Human services should better ensure that valid methods are used to demonstrate budget neutrality, by developing and implementing consistent criteria for consideration of section 1115 demonstration waiver proposals.

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

Comments: As of January 2020, the Department of Health and Human Services (HHS) had taken some action to address GAO's 2002 recommendation. In August 2018, HHS issued written guidance through a State Medicaid Directors Letter documenting four key changes it made in 2016 to its budget neutrality policy. These changes addressed some, but not all of the questionable methods GAO identified in its reports. To fully address this recommendation, HHS should also address these other questionable methods, such as setting demonstration spending limits based on hypothetical costs-what the state could have paid-rather than payments actually made by the state. GAO has found that the use of hypothetical costs has the potential to inflate spending limits and thus threatens budget neutrality of demonstrations