"Title: Download of GAO Recommendation Results",,,,,,, "Prepared by: GAO",,,,,,, "Source: GAO recommendations database, status as of Mar 28, 2024 at 2:15 PM EST" ,,,,,,, ,,,,,,,, ,,,,,,,, "Publication Name","Publication Number","Date Publication Issued","Director Name","Director Phone",Agency,Recommendation,Status,Priority,Comments "Maternal and Infant Health: HHS Should Strengthen Processes for Measuring Program Performance",GAO-24-106605,"Mar 27, 2024","Mary Denigan-Macauley","(202) 512-7114","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,No,"When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information." "Maternal and Infant Health: HHS Should Strengthen Processes for Measuring Program Performance",GAO-24-106605,"Mar 27, 2024","Mary Denigan-Macauley","(202) 512-7114","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,No,"When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information." "340B Drug Discount Program: Oversight of the Intersection with the Medicaid Drug Rebate Program Needs Improvement",GAO-20-212,"Jan 27, 2020","Debra A. Draper","(202) 512-7114","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,No,"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,"Jan 27, 2020","Debra A. Draper","(202) 512-7114","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,No,"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,"Jan 10, 2020","Debra A. Draper","(202) 512-7114","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,No,"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." "340B Drug Discount Program: Increased Oversight Needed to Ensure Nongovernmental Hospitals Meet Eligibility Requirements",GAO-20-108,"Jan 10, 2020","Debra A. Draper","(202) 512-7114","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,No,"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." "340B Drug Discount Program: Increased Oversight Needed to Ensure Nongovernmental Hospitals Meet Eligibility Requirements",GAO-20-108,"Jan 10, 2020","Debra A. Draper","(202) 512-7114","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,No,"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,"Jan 10, 2020","Debra A. Draper","(202) 512-7114","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",No,"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." "Drug Discount Program: Federal Oversight of Compliance at 340B Contract Pharmacies Needs Improvement",GAO-18-480,"Jun 28, 2018","Debra A. Draper","(202) 512-7114","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,No,"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." "Drug Discount Program: Federal Oversight of Compliance at 340B Contract Pharmacies Needs Improvement",GAO-18-480,"Jun 28, 2018","Debra A. Draper","(202) 512-7114","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,No,"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." "Drug Discount Program: Federal Oversight of Compliance at 340B Contract Pharmacies Needs Improvement",GAO-18-480,"Jun 28, 2018","Debra A. Draper","(202) 512-7114","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,No,"HHS does not concur with this recommendation and, as of March 2024, did not plan to take any actions to implement the recommendation. In March 2023, HRSA noted that as long as the contract with a pharmacy says it includes all of the covered entities' sites, HRSA does not require the entity to register the pharmacy for each individual site. HRSA's draft audit protocols call for auditors to verify if the pharmacy contract specifies it includes all entity sites, and, if it does not, the auditor is to verify whether the pharmacy is registered for each entity site that is included in the contract. However, since HRSA only audits 200 covered entities per year, such procedures do not provide HRSA with complete data on entities' contract pharmacy arrangements. In March 2024, HRSA said that contracts with a pharmacy generally state that the contracted relationship applies to all sites of the covered entity. However, it is unclear how HRSA would know this since it only reviews contracts for a small sample of covered entities each year. Thus, HRSA does not know the extent to which covered entities' contracts with pharmacies may not apply to all entities sites and therefore does not have complete data on contract pharmacy arrangements. Such data are also important for manufacturers to help ensure that 340B discounted drugs are only shipped to pharmacies on behalf of a covered entity site with a valid 340B contract with that site." "Drug Discount Program: Federal Oversight of Compliance at 340B Contract Pharmacies Needs Improvement",GAO-18-480,"Jun 28, 2018","Debra A. Draper","(202) 512-7114","Health Resources and Services Administration","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,Yes,"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 February 2024, HRSA noted that the agency may be able to issue guidance to covered entities on the prevention of duplicate discounts under Medicaid managed care pending the outcome of a proposed CMS rule related to the Medicaid Drug Rebate program." "Drug Discount Program: Federal Oversight of Compliance at 340B Contract Pharmacies Needs Improvement",GAO-18-480,"Jun 28, 2018","Debra A. Draper","(202) 512-7114","Health Resources and Services Administration","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,Yes,"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 February 2024, HRSA noted that the agency may be able to issue guidance to covered entities on the prevention of duplicate discounts under Medicaid managed care pending the outcome of a proposed CMS rule related to the Medicaid Drug Rebate program. HRSA would then need to update its audit processes accordingly to implement this recommendation." "Drug Discount Program: Federal Oversight of Compliance at 340B Contract Pharmacies Needs Improvement",GAO-18-480,"Jun 28, 2018","Debra A. Draper","(202) 512-7114","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,No,"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." "Drug Discount Program: Federal Oversight of Compliance at 340B Contract Pharmacies Needs Improvement",GAO-18-480,"Jun 28, 2018","Debra A. Draper","(202) 512-7114","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,No,"HHS does 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 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."