District Court Rules That Medicare 340B Rx Pricing Program Excludes ‘Orphan’ Drugs for Rare Conditions
Hospitals and other stakeholders say that a district court's ruling on Thursday that excludes "orphan" drugs -- which are developed to treat rare conditions -- from the 340B Drug Pricing Program for rural and cancer hospitals could reduce funds needed to provide uncompensated care. Under the 340B program, drugmakers must offer discounts of between 20% and 50% to providers that serve low-income individuals. Pharmaceutical Research and Manufacturers of America had sued HHS over the interpretive rule, arguing in part that it undermined drugmakers' incentives to research and develop new orphan medications. On Thursday, U.S. District Judge Rudolph Contreras issued a ruling that sided with PhRMA and vacated the interpretive rule. Contreras wrote in the ruling that the interpretive rule was "contrary to the plain language" of federal law.
- "Judge Sides With Drugmakers and Narrows 340B Drug Discounts" (Schencker, Modern Healthcare, 10/15).
- "AHA 'Very Disappointed' With Court's Ruling in 340B Orphan Drug Case" (AHA News, 10/15).