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HRSA releases proposed rule implementing 340B program orphan drug exclusion

  • Manatt Phelps & Phillips LLP
  • -
  • USA
  • -
  • May 19 2011

On May 19, 2011, the Office of the Federal Register put on display a Notice of Proposed Rulemaking ("NPRM") implementing a provision of the Affordable Care Act ("ACA") that prohibits certain newly-eligible Covered Entities from receiving discounts on orphan drugs under the 340B Drug Discount Program

Supreme Court rules 340b covered entities cannot sue drug manufacturers over drug pricing disputes

  • Manatt Phelps & Phillips LLP
  • -
  • USA
  • -
  • March 29 2011

On March 29, 2011, the Supreme Court, in a unanimous opinion by Justice Ruth Bader Ginsburg, ruled that safety-net health care providers, such as eligible hospitals and community health centers, enrolled in the federal 340B Drug Discount Program (the "340B Program") do not have a right to sue drug manufacturers for alleged overpricing of drugs they sell under the program