New bipartisan bill calls for 340B reform

A bipartisan group of senators introduced a bill in early August to clarify requirements, increase oversight, and reform the payment and data infrastructure of the 340B Drug Pricing Program. If passed, the Supporting Underserved and Strengthening Transparency, Accountability and Integrity Now and for the Future of 340B Act (SUSTAIN 340B Act) would mark the first time the program’s rules are codified in statute.

The bill would codify requirements for who qualifies as a 340B patient, including a qualifying service within the prior two years and an auditable medical record. It would also establish requirements for prescriptions resulting from referrals to non-340B providers.

Another key provision in the bill would terminate the 340B Rebate Model Pilot Program. Under the pilot, a covered entity initially purchases an eligible drug at the regular price. After the transaction is verified, the entity receives a manufacturer rebate that brings the price down to the 340B ceiling price. The bill directs HHS to terminate the program within one year of enactment and prohibits the department from expanding the pilot or any similar rebate program.

Instead, the bill would establish a national data clearinghouse (operated by an independent third party) to collect and validate claims data, prevent diversion, and identify duplicate discounts in the 340B program.

The legislation would codify the use of contract pharmacies in the 340B program. Covered entities would be required to register and annually recertify contract pharmacy arrangements with HHS, submit agreements before implementation, and cancel arrangements with pharmacies that have not dispensed 340B drugs in the previous year, with limited exceptions. The bill would also require manufacturers to provide 340B drugs to contract pharmacies without imposing certain distribution or data-reporting restrictions.

Other provisions in the SUSTAIN 340B Act include patient financial assistance requirements, new child-site requirements, enhanced auditing and reporting, and additional protections for providers and pharmacies.