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Open Recommendations (15 total)

Maternal and Infant Health: HHS Should Strengthen Processes for Measuring Program Performance

GAO-24-106605
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1 Open Recommendations
Agency Affected Recommendation Status
Health Resources and Services Administration The Administrator of HRSA should implement a documented process to review Healthy Start performance measures (including their definitions, associated data collection forms, and data dictionary), before a grant period begins, to ensure they are clear and allow for the collection of reliable data. (Recommendation 1)
Open – Partially Addressed
HHS partially agreed with this recommendation. In September 2024, HHS provided a standard operating procedure (SOP) HRSA created in August 2024 to be used for reviewing Healthy Start performance measures. This SOP outlines considerations and steps that program staff should take to determine whether to update the program's performance measure definitions, associated data collection forms, and data dictionary. It states that implementation of the SOP should start 2 years prior to the next grant period; however, the SOP lacks details about the timing needed to conduct the steps within the SOP to ensure that all SOP steps are completed before a grant period begins. The SOP also lacks details on how the process ensures that the measures (including their definitions, associated data collection forms, and data dictionary) are clear to grantees. GAO will continue to monitor HRSA's efforts towards implementing this recommendation to ensure the agency's actions result in the establishment of clear measures before the next grant period begins. Therefore, GAO considers this recommendation open.

Maternal and Infant Health: HHS Should Strengthen Processes for Measuring Program Performance

GAO-24-106605
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1 Open Recommendations
Agency Affected Recommendation Status
Health Resources and Services Administration The Administrator of HRSA should implement a documented process for program officials to coordinate the selection of performance measures across its related programs—Healthy Start; the Maternal, Infant, and Early Childhood Home Visiting; and the Title V Maternal and Child Health Services Block Grant. (Recommendation 2)
Open – Partially Addressed
HHS concurred with this recommendation. In September 2024, HHS provided a HRSA memo from April 2024 that detailed steps the agency planned to implement to review existing performance measures across its related programs. The memo described which staff were to be involved, what activities they would complete, and the associated time frames. For example, one step was to convene a workgroup to review existing performance measures. According to HHS, the workgroup was formed and developed options to align measures but had not finalized any decisions as of September 2024. GAO will continue to monitor HRSA's progress toward implementing this recommendation, including reviewing the workgroup's decisions. Further, HRSA's steps, as described in the memo, are one-time only actions. Given that performance measures may change over time, a process to ensure that coordination occurs on a recurring basis is needed, per GAO's recommendation. Therefore, GAO considers this recommendation open.

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

GAO-20-212
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1 Open Recommendations
Agency Affected 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 March 2024, 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 to ensure covered entities' compliance with 340B Program requirements.

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

GAO-20-212
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1 Open Recommendations
Agency Affected Recommendation Status
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 March 2024, 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.

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

GAO-20-108
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3 Open Recommendations
Agency Affected Recommendation Status
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 March 2024, 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.
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 March 2024, 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.
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 March 2024, 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 are appropriately identifying deficiencies in nongovernmental hospitals' contracts with state or local governments.

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

GAO-20-108
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1 Open Recommendations
Agency Affected 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 March 2024, 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.

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

GAO-18-480
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2 Open Recommendations
Agency Affected 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 March 2024, 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.
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 March 2024, HRSA noted that its existing regulatory authority to issue guidance is subject to ongoing legal challenges. HRSA officials told us that since FY2017 it had requested additional regulatory authority for the program. The FY2025 President's Budget includes a proposal to provide HRSA explicit regulatory authority to define necessary terms for the program.
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