CHA News Article

HHS Continues to Allow 340B Orphan Drug Discounts

The Health Resources and Services Administration (HRSA) announced yesterday that it will continue to allow covered entities to purchase orphan drugs through the 340B Drug Pricing Program as long as the drugs are not used to treat the conditions for which the orphan drug designation was given. Despite a recent federal court decision that seemed to rule against HRSA regulations for 340B drugs, HRSA maintains that the court did not invalidate its interpretation of the statute. HRSA has also posted updated orphan drug designation lists and an orphan drug selection file to assist 340B stakeholders in complying with its policy. The orphan drug exclusion policy applies to critical access hospitals, sole community providers, rural referral centers and free-standing cancer hospitals.