HB4581, the 340B PATIENTS Act of 2025, would amend section 340B of the Public Health Service Act to strengthen and clarify the federal drug discount program for covered entities such as hospitals, clinics, and health centers. The bill states that drug manufacturers must provide 340B discounted pricing regardless of where or how a covered outpatient drug is dispensed, including through contract pharmacies, and it bars manufacturers from imposing conditions that limit delivery, dispensing, claims submission, or other business practices that would undermine the program.
The bill also makes explicit that covered entities may use contract pharmacies to dispense 340B drugs to patients, and that manufacturers’ obligations apply equally when a covered entity uses those pharmacies. It adds enforcement provisions authorizing civil monetary penalties for intentional violations of the new restrictions, with penalties that can reach up to $2 million per day, and directs the Secretary of Health and Human Services to issue regulations within 180 days to implement the new standards and claims process.
Impact
If enacted, the bill would amend 340B provisions in the Public Health Service Act by codifying protections for contract pharmacy arrangements and limiting manufacturer restrictions on discounted drug access. It would expand the statutory basis for covered entities to obtain 340B drugs through pharmacies of their choice, create new compliance and enforcement mechanisms, and require HHS rulemaking to define and administer violations and claims. The measure would primarily affect drug manufacturers, 340B covered entities, contract pharmacies, and patients served by safety-net providers, especially those relying on specialty or mail-order pharmacy access.
Sentiment
The bill’s stated purpose and findings reflect strong support for the 340B program and for preserving contract pharmacy access, emphasizing that the program helps safety-net providers stretch scarce resources and reach more patients. The bill was introduced by a group of Democratic sponsors and referred to committee, with no recorded votes or committee transcript in the provided materials. Based on the text, the overall sentiment is supportive of expanding and protecting 340B access rather than limiting it.
Contention
The main point of contention is the scope of manufacturer obligations and whether manufacturers may impose conditions on 340B dispensing, especially through contract pharmacies. The bill takes the position that manufacturers should not restrict where drugs are delivered, administered, or dispensed, or require claims data or other conditions that could discourage participation. This directly addresses disputes that have arisen over manufacturer attempts to limit contract pharmacy distribution and over what business practices are permissible under 340B. The bill also raises enforcement stakes by authorizing substantial daily penalties for intentional violations, which manufacturers may view as significant regulatory exposure.
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