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As of January 31, 2023, there are 4840 open recommendations that still need to be addressed. 471 of these are priority recommendations, those that we believe warrant priority attention. Learn more about our priority designation on our Recommendations page.

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1 - 15 of 15 Recommendations, including 2 Priority Recommendations

COVID-19: Additional Actions Needed to Improve Accountability and Program Effectiveness of Federal Response

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2 Open Recommendations
Agency Recommendation Status
Health Resources and Services Administration The Administrator of the Health Resources and Services Administration should establish time frames for completing post-payment reviews to promptly address identified risks and identify overpayments made from the Provider Relief Fund, such as payments made in incorrect amounts or payments to ineligible providers. See the Relief for Health Care Providers enclosure. (Recommendation 1)
Open

HRSA partially concurred with this recommendation. HRSA has a broad schedule of plans to conduct post-payment reviews. According to HRSA officials, they plan to schedule reviews in 2022, but the agency has not indicated when all of its reviews of payments will be scheduled, or completed. In March 2022, HRSA reported that it started performing post-payment reviews in October 2020. HRSA also stated that it has identified 58 types of reviews, each of which is currently either open, closed, scheduled for review, or to be scheduled for review. HRSA stated that it tracks the status and schedule of

Health Resources and Services Administration The Administrator of the Health Resources and Services Administration should finalize procedures and implement post-payment recovery of any Provider Relief Fund overpayments, unused payments, or payments not properly used. See the Relief for Health Care Providers enclosure. (Recommendation 2)
Open

HRSA partially concurred with this recommendation. Despite initial actions to address this recommendation, HRSA has suspended its post-payment recovery efforts. In March 2022, HRSA provided updated data for the total funds identified for recovery or potential repayment. HRSA has two categories of unused funds for which the agency will seek repayment. HRSA stated that it will seek repayment for all PRF payments reported as unused. For providers who HRSA required to report and failed to do so, HRSA will move forward to seek repayment of the full payment amount. However, HRSA told us that it has

340B Drug Discount Program: Oversight of the Intersection with the Medicaid Drug Rebate Program Needs Improvement

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2 Open Recommendations
Agency Recommendation Status
Health Resources and Services Administration 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)
Open

HHS did not concur with this recommendation and, as of January 2023, 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 ensure covered entities have adequate mechanisms in place to prevent duplicate discounts and

Health Resources and Services Administration 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)
Open

HHS did not concur with this recommendation and, as of January 2023, 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

340B Drug Discount Program: Increased Oversight Needed to Ensure Nongovernmental Hospitals Meet Eligibility Requirements

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4 Open Recommendations
Agency Recommendation Status
Health Resources and Services Administration 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)
Open

HHS concurred with this recommendation and , in January 2023, 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

Health Resources and Services Administration 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)
Open

HHS did not concur with this recommendation and, as of January 2023, 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

Health Resources and Services Administration 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)
Open

HHS concurred with this recommendation and in January 2023, 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 and directing auditors to contact HRSA if there are questions regarding this requirement. 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

Health Resources and Services Administration 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)
Open – Partially Addressed

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, to fully implement the recommendation, 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 January

Drug Discount Program: Federal Oversight of Compliance at 340B Contract Pharmacies Needs Improvement

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7 Open Recommendations
2 Priority
Agency Recommendation Status
Health Resources and Services Administration 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)
Open

HHS does not concur with this recommendation and, as of January 2023, 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

Health Resources and Services Administration 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)
Open

HHS concurred with this recommendation. After the report was issued, 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. In January 2023, HRSA noted that the agency had requested regulatory authority for all aspects of the 340B Program in the FY 2023 President's Budget.

Health Resources and Services Administration 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)
Open

HHS does not concur with this recommendation and, as of March 2021, indicated that it did not plan to take any actions to implement the recommendation. After the report was issued, HHS indicated that it believes that guidance does not provide HRSA appropriate enforcement capability. In January 2023, HRSA noted that the agency had requested regulatory authority for all aspects of the 340B Program in the FY 2023 President's Budget. However, HRSA already requires covered entities to register contract pharmacies, just not for each site of the entity for which a contract exists. Thus, it is unclear

Health Resources and Services Administration
Priority Rec.
This is a priority 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)
Open

HHS concurred with this recommendation. After the report was issued, 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. In January 2023, HRSA noted that the agency had requested regulatory authority for all aspects of the 340B Program in the FY 2023 President's Budget.

Health Resources and Services Administration
Priority Rec.
This is a priority 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)
Open

HHS concurred with this recommendation. After the report was issued, 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. In January 2023, HRSA noted that the agency had requested regulatory authority for all aspects of the 340B Program in the FY 2023 President's Budget.

Health Resources and Services Administration 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)
Open

HHS concurred with this recommendation. After the report was issued, 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. In January 2023, HRSA noted that the agency had requested regulatory authority for all aspects of the 340B Program in the FY 2023 President's Budget.

Health Resources and Services Administration 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)
Open

HHS does not concur with this recommendation and, as of January 2023, 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

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For questions about a specific recommendation, contact the person or office listed with the recommendation. For general information about recommendations, contact GAO's Audit Policy and Quality Assurance office at (202) 512-6100 or apqa@gao.gov.