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The HHS Health Resources and Services Administration has withdrawn sweeping regulations for the 340B drug pricing program and instead intends to issue proposed guidance addressing key policy issues beginning in 2015.

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. 

However, HRSA subsequently re-issued the policy that allows 340B-covered entities 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. In October, PhRMA filed another suit seeking to vacate the interpretive rule HRSA issued.

With HRSA deciding to scrap what many in the industry are referring to as a "mega rule," hospitals, health systems and drug manufacturers will have to wait to receive more guidance regarding the program. HRSA announced there will be an opportunity for the public to comment on 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." 

More articles on the 340B program: 

Are hospitals abusing the 340B drug discount program? New study reignites controversy 
340B Program: Time to recertify  
HHS issues interpretive rule allowing 340B orphan drug exclusion 

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