On August 11 the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (RIN 0906-AA90) that would implement an administrative dispute resolution (ADR) process that would apply to all drug manufacturers and covered entities that participate in the 340B drug pricing program.

The rule if implemented as proposed will establish and implement a binding ADR to resolve:  (i) claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers; and (ii) claims by manufacturers after they have conducted an audit that a covered entity has violated the statutory prohibition on diversion of 340B drugs to ineligible patients or duplicate discounts.

The rule when finalized will replace the 340B program’s guidelines on the informal dispute resolution process developed to resolve disputes between covered entities and manufacturers, which was published in December 1996 (61 Federal Register 65406 (Dec. 12, 1996)).

The proposed rule will be published in the Federal Register on August 12 and public comments must be submitted to HRSA no later than October 11.

The proposed rule is available at FederalRegister.gov.