HRSA proposed rule would establish dispute resolution process for 340B program

The Health Resources and Services Administration today released a proposed rule that would implement an Affordable Care Act provision requiring a binding administrative dispute resolution process for 340B Drug Pricing Program participants who claim they have been overcharged for drugs purchased through the program. 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 proposed rule will be published in the Aug. 12 Federal Register with comments accepted through Oct. 11. AHA staff are reviewing the rule, and member hospitals that are 340B participants will receive more information.