HHS withdraws 340B ‘mega rule’

The HHS Health Resources and Services Administration has withdrawn sweeping regulations for the 340B drug pricing program and instead intends to issue proposed guidance addressing key policy issues beginning in 2015.

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Last year, Pharmaceutical Research and Manufacturers of America filed a lawsuit challenging a final HHS rule that expanded the 340B drug discount program. PhRMA filed the suit in an attempt 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 HHS doesn’t have the authority to put regulations into place that implement Patient Protection and Affordable Care Act 340B provisions.

Read the full report on Becker’s Hospital Review.

 

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