HHS is evaluating its options for responding to a federal court ruling last month that struck down a final rule from the agency allowing rural and cancer hospitals to access 340B drug program discounts on orphan drugs when the drugs are not used for the rare conditions that resulted in orphan designation, according to an AHA News report.
The Pharmaceutical Research and Manufacturers of America filed the suit, seeking to exclude all drugs with an "orphan" designation — a drug that has been developed specifically to treat a rare condition and often carries a hefty price tag — from the final rule. U.S. District Judge Rudolph Contreras ruled in favor of PhRMA, finding that HHS does not have the authority to implement regulations implementing PPACA 340B provisions.
In a document filed with the court, HHS indicated its options are appealing the decision or propounding a rule putting forth its interpretation of the law concerning orphan drug exclusion, according to the report.
Hospital associations, including the American Hospital Association and Safety Net Hospitals for Pharmaceutical Access, have supported HHS in the suit.
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