This bill clarifies that drug manufacturers participating in the 340B program must offer discounted prices on medications to covered entities like hospitals, clinics, and health centers regardless of whether those drugs are dispensed directly or through contracted pharmacies. The legislation prevents manufacturers from placing conditions on purchases that would discourage covered entities from using the program, such as restricting where drugs can be delivered or requiring submission of claims data. The bill affects drug manufacturers, hospitals, clinics, health centers, and patients who rely on these facilities for care. It establishes new civil penalties up to $2 million per day for manufacturers who knowingly violate these requirements, with the Department of Health and Human Services required to develop regulations within 180 days to enforce the rules and allow covered entities to report violations. The changes are intended to help hospitals and clinics stretch limited resources by using 340B savings to serve more patients and provide comprehensive services, particularly for specialty drugs used to treat serious conditions like cancer and arthritis.
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