HHS/HRSA stand firm in allowing 340B orphan drug discounts

AHA News Now

The Department of Health and Human Services and its Health Resources and Services Administration will continue to allow hospitals subject to the orphan drug exclusion 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, according to an HHS document filed yesterday in the U.S. District Court for the District of Columbia. Responding to a June 19 motion by the Pharmaceutical Research and Manufacturers of America, which challenged the agency’s position, HHS stated that it has authority to continue the discounts and that HRSA will issue additional guidance on the purchase of orphan drugs through the 340B program. In May, the court vacated HHS’ adoption of a rule to implement the policy; however, it did not invalidate HRSA’s interpretation of the statute. The orphan drug exclusion policy applies to critical access hospitals, sole community providers, rural referral centers and free-standing cancer hospitals.

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