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340B Drug Discount Program: oversight of the Intersection with the Medicaid Drug Rebate Program needs improvement : report to Congressional requesters
340B Drug Discount Program: oversight of the Intersection with the Medicaid Drug Rebate Program needs improvement : report to Congressional requesters
Why GAO did this study. Covered entities can receive substantial discounts on outpatient drugs through the 340B Program, an estimated 25 to 50 percent of the cost of the drugs, according to HRSA. Additionally, Medicaid drug rebates are an important source of savings for states and the federal government, saving more than $36 billion in fiscal year 2018. However, ensuring that manufacturers are not subject to both discounts requires coordination within HHS, and between covered entities and states. GAO was asked to provide information on the prevention of duplicate discounts. Among other things, this report examines HHS’s efforts to ensure compliance with the prohibition on duplicate discounts. GAO reviewed documentation, including federal policies and those from all 50 states and Washington, D.C. on preventing duplicate discounts. GAO also interviewed officials from CMS, HRSA, and 16 covered entities from four states selected to obtain variation in the types of entities and other factors. What GAO recommends. GAO is making three recommendations, namely that: 1) CMS ensure that state Medicaid programs have written policies and procedures that are designed to prevent duplicate discounts and forgone rebates; and that HRSA 2) incorporate covered entities’ compliance with state policies into its audits, and 3) require covered entities to work with manufacturers regarding repayment of identified duplicate discounts in managed care. HHS agreed with the recommendation to CMS, but disagreed with those to HRSA. GAO continues to believe these are needed to improve oversight and the integrity of the 340B Program, as explained in the report.
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