The US Department of Health and Human Services (HHS) Office of the General Counsel this week released an advisory opinion concluding that drug manufacturers are required to deliver discounts under the 340B Drug Pricing Program (340B Program) on covered outpatient drugs when contract pharmacies are acting as agents of 340B covered entities.
The 340B Program requires drug manufacturers (in exchange for coverage of drugs under Medicaid, the state and federal program that provides health coverage for very low income patients) to offer substantial discounts to "covered entities," which include safety net hospitals, community health centers, and other institutions that serve vulnerable populations. Estimates suggest that discounts in the 340B Program can range between 25% and 50% and that around $30 billion of drugs are sold to covered entities each year, representing almost 6% of prescription drugs sold in the USA.
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