Health and Human Services Delays the 340B 'Mega Rule'

The HHS Health Resources and Services Administration has withdrawn sweeping rules for the 340B drug pricing program and instead plans to provide proposed guidance addressing vital policy issues starting in 2015.

Last year, Pharmaceutical Research and Manufacturers of America submitted a lawsuit challenging a final HHS regulation that broadened the 340B drug discount program. PhRMA filed the suit in an attempt to omit all drugs with an "orphan" designation-- a pharmaceutical that has been developed specifically to treat a rare condition and frequently carries a hefty cost-- from the final rule. U.S. District Judge Rudolph Contreras ruled in favor of PhRMA, finding HHS doesn't possess the power to place policies into place which implement Patient Protection and Affordable Care Act 340B provisions.

However, HRSA consequently re-issued the policy that enables 340B-covered entities to buy orphan drugs at 340B rates when orphan drugs are used for any indicator apart from dealing with the rare disease or condition for which the drug received an orphan classification. In October, PhRMA filed an additional suit seeking to revoke the interpretive rule HRSA issued.

With HRSA opting to ditch what many in the sector are referring to as a "mega rule," health centers, health systems and pharmaceutical companies will have to wait to be given more direction regarding the program. HRSA declared there will be an opportunity for the public to discuss the guidance it issues, and American Hospital Association Executive Vice President Rick Pollack said "The AHA looks forward to working with HRSA on its efforts to improve the 340B drug pricing program, which is vital to so many vulnerable patients and communities.".