CHA News Article

Court Rules to Limit Access to ‘Orphan’ Drugs Under 340B Program

Late last week a federal court ruled against the Department of Health and Human Services (HHS) in a lawsuit brought by the Pharmaceutical Research and Manufacturers of America, seeking to exclude all drugs with an “orphan” designation from the 340B drug pricing program. Last year HHS issued a final rule allowing certain 340B hospitals (critical access, sole community providers, rural referral centers and freestanding cancer hospitals) to purchase orphan drugs under the 340B program if they did not use them to treat conditions for which the orphan drug designation was given. As a result of the court’s latest ruling, the HHS final rule is no longer in effect.