HHS may appeal, issue guidance regarding 340B orphan drug exclusion

AHA News Now

The Department of Health and Human Services is evaluating its options for responding to a recent federal court ruling that invalidated a 2013 final rule allowing certain hospitals to purchase “orphan drugs” through the 340B Drug Pricing Program when the drugs are not used to treat the rare conditions for which the orphan drug designation was given. In a document filed with the court yesterday, HHS said its options include appealing the decision or propounding a rule or guidance setting forth its interpretation of the law regarding the program’s orphan drug exclusion. “HHS does not interpret the Court’s decision as precluding it from issuing an interpretive rule or other type of interpretive guidance, even if the rule or guidance sets forth the same interpretation previously embodied in the challenged regulation,” the agency wrote. The U.S. District Court for the District of Columbia last month ruled that HHS and its Health Resources and Services Administration did not have the rulemaking authority to issue, as a legislative rule, its new regulation addressing the treatment of orphan-designated drugs under the Section 340B Program. The 2013 rule applied to critical access hospitals, sole community providers, rural referral centers and free-standing cancer hospitals. AHA filed a friend-of-the-court brief supporting HHS in the lawsuit, which was brought by the Pharmaceutical Research and Manufacturers of America.

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