340B ACCESS Act

This proposal updates the federal 340B drug discount program. It lowers pharmacy costs for many low‑income and uninsured patients and sets clearer rules for hospitals, clinics, and partner pharmacies, while stopping health plans and pharmacy benefit managers from treating 340B drugs unfairly.

Key points

• Patient costs: Hospitals in 340B must post a simple discount policy and cap what eligible patients pay for each medicine: $0 if income is below the poverty line; up to $35 between 100%–200% of the poverty line; and up to $50 at higher incomes, with annual inflation updates. For self‑administered drugs, the discount applies at the counter; violations can bring $2,500 fines.
• Nonhospital clinics: If their federal program already requires affordability help, they must ensure no one is denied a 340B drug because they can’t pay.
• Health plans and PBMs: They cannot deny coverage or add extra hurdles just because a drug is a 340B drug, and they can’t block required co‑pay discounts; PBMs can be fined up to $5,000 per violation per day. These rules also apply to Medicare drug and Advantage plans.
• Pharmacies: Pharmacies that partner with 340B providers must honor the patient discounts and follow new registration and compliance steps.
• Tracking and oversight: All 340B claims must carry a clear tag, and providers/pharmacies must send claim‑level data to a national clearinghouse. Medicaid and Medicare must also send drug claims data quickly. The clearinghouse checks for duplicate discounts so drug makers don’t pay twice.
• Hospitals: New standards apply to off‑campus “child sites,” with deadlines to register or remove sites that don’t qualify. Some hospitals must show their charity care is at least as large as their 340B savings (“margin”) or leave the program. Certain private nonprofit urban hospitals must rank in the top 40% on state lists or deregister. The bill also bans harsh debt collection tactics against uninsured or low‑income patients.
• One national standard: The bill overrides conflicting state or local rules related to 340B.
• When: Most changes start one year after it becomes law; some parts, like the child‑site rules, start sooner.