The pharmaceutical industry notched another win in its campaign to rein in the federal 340B drug pricing program. Last week, a federal judge struck down the Obama administration's policy giving rural and cancer hospitals discounts on orphan drugs.
It was unclear late Friday whether the administration would appeal the ruling.
The drug industry's lobbying group, the Pharmaceutical Research and Manufacturers of America, has twice sued over HHS' attempts to implement the policy through different forms of regulation.
The Affordable Care Act expanded access to 340B drug discounts, but excluded orphan drugs from the program. HHS, however, interpreted the law to allow discounts when those drugs were used to treat something other than the rare diseases and conditions they were developed to target.
Hospital groups say the decision could lead to higher prices for patients, block access to drugs and limit uncompensated care at already struggling hospitals.
But they're also focused on the drug industry's broader battle against the growth of the program and the sweeping 340B guidance that HHS proposed this past summer.
The orphan drug ruling may have a significant impact on certain hospitals, said Rena Conti, an assistant professor at the University of Chicago, who specializes in health policy and economics, “but it's likely small in comparison to what the impact of the mega-rule guidance will be on all covered entities,” she said.