HRSA issues proposed rule on drug pricing dispute resolution


HRSA logoThe Health Resources and Services Administration (HRSA) is proposing a dispute resolution process for 340B Drug Pricing Program hospitals and clinics that claim they have been overcharged for drugs purchased through the program.

The proposed rule, published in the Aug. 12 Federal Register, would implement the Affordable Care Act provision requiring the binding administrative dispute resolution. Under the proposed process, which also would be available to drug manufacturers, a decision-making body within the Department of Health and Human Services would review and resolve the claims.

The American Hospital Association (AHA) says it’s concerned that hospitals do not have access to the 340B drug ceiling price information that HRSA would require them to submit as part of a dispute initiation. The AHA says it is reviewing the proposed rule further and will seek feedback from its 340B member hospitals.

Comments on the proposed rule are due Oct. 11.