CHA News Article

HRSA Releases Interpretive Rule on 340B Orphan Drug Discounts

The Department of Health and Human Services (HHS) and its Health Resources and Services Administration (HRSA) have issued the attached interpretive rule on the 340B Drug Pricing Program. The rule continues to allow hospitals subject to the “orphan drug” exclusion to purchase those drugs through the 340B program when the drugs are not used to treat the rare conditions for which the orphan drug designation was given. In May, a federal court vacated HHS’ adoption of a regulation to implement the orphan drug exclusion policy. The interpretive rule is effective July 23.