The HHS Health Resources and Services Administration has decided to stand by its final rule 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, in spite of a federal court ruling last month against the agency's 340B final rule.
The Pharmaceutical Research and Manufacturers of America filed a lawsuit 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. Hospital associations, including the American Hospital Association and Safety Net Hospitals for Pharmaceutical Access, have supported HHS in the suit.
Last month, 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.
"However, the Court did not invalidate HRSA's interpretation of the statute," HRSA states on its website. "HHS/HRSA continues to stand by the interpretation described in its published final rule, which allows the 340B covered entities affected by the orphan drug exclusion to purchase orphan drugs at 340B prices when orphan drugs are used for any indication other than treating the rare disease or condition for which the drug received an orphan designation."
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The 340B Drug Discount Program Controversy: 5 Things to Know