HHS Reissues Dsputed 340B Policy on Orphan-Drug Discounts

HHS issued an interpretive rule that requires drug companies to provide discounts on orphan drugs sold through a federal program just months after a judge struck down the government's previous version of the rule.

HHS issued an interpretive rule (PDF) that requires drug companies to provide discounts on orphan drugs sold through a federal program just months after a judge struck down the government's previous version of the rule.

The drug industry has contested the Obama administration's interpretation of a provision in the Patient Protection and Affordable Care Act, arguing that the government didn't have the authority to issue the legislative rule in 2013. The Pharmaceutical Research and Manufacturers of America, the drug industry's lobbying group, sued HHS last year, and a federal judge ruled against HHS in May. The administration, however, took the position that the outcome allowed it to reissue the same policy in a different form.

The new version of the rule, posted to the Federal Register on July 21, requires drug companies to provide discounts between 20% and 50% on orphan drugs used for non-orphan conditions or diseases to freestanding cancer hospitals, critical-access hospitals, rural referral centers and sole community hospitals that participate in the 340B program.

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Source: Modern Healthcare