HR4581-119

What This Bill Does

The 340B PATIENTS Act codifies strong protection for contract-pharmacy dispensing under the 340B drug discount program. Congressional findings state that 340B lets hospitals, clinics, and health centers stretch scarce resources, that manufacturers participating in Medicaid and Medicare Part B must offer discounted outpatient drugs to covered entities, and that covered entities have long used contract pharmacies to dispense drugs to their patients. The operative amendments require manufacturers to furnish covered outpatient drugs at or below the 340B ceiling price regardless of the manner or location in which the drug is dispensed. Manufacturers may not place conditions on covered-entity purchase or use if those conditions limit delivery, limit purchase mechanisms, restrict delivery, administration, or dispensing locations, demand assurances of compliance, require claims data or other information, deviate from customary business practices, discourage 340B purchases, single out covered entities, disproportionately affect covered entities, or lack advance approval from HHS. The bill expressly applies the requirements and prohibitions when a covered entity contracts with one or more pharmacies to dispense drugs to the covered entity's patients.

Who Benefits and How

340B covered entities benefit from statutory protection for discounted drugs dispensed through contract pharmacies. Safety-net hospitals benefit because manufacturers could not condition 340B pricing on dispensing location or claims-data submissions without approval. Community health centers benefit from preserved contract-pharmacy access for patients who use outside pharmacies. Patients of 340B covered entities benefit if providers retain savings used for care, services, and medication access.

Who Bears the Burden and How

Drug manufacturers participating in Medicaid and Medicare Part B must offer 340B pricing without unapproved dispensing-location or delivery conditions. Manufacturers restricting contract pharmacies must stop conditions that limit delivery, purchase mechanisms, dispensing sites, or claims-data access unless approved by HHS. HHS must approve or police manufacturer conditions and enforce the new 340B prohibitions. HRSA 340B program staff must administer disputes and guidance around contract-pharmacy compliance.

Key Provisions

• Requires manufacturers to offer 340B ceiling-price drugs regardless of dispensing manner or location.
• Prohibits unapproved manufacturer conditions on delivery, purchase mechanisms, dispensing locations, compliance assurances, or claims-data submissions.
• Blocks conditions that discourage 340B purchasing, single out covered entities, or disproportionately affect covered entities.
• Applies the protections to covered entities contracting with one or more pharmacies to dispense to their patients.
• Preserves covered-entity use of 340B savings for patient care and community services.