HRSA: 340B hospitals should get refunds for overcharged orphan drugs

AHA News Now

Some drug manufacturers should refund hospitals participating in the 340B Drug Pricing Program for certain orphan drugs they charged hospitals at non-discounted prices, the Health Resources and Services Administration told drug manufacturers this month. HRSA, which oversees the 340B program, sent letters to more than 50 drug manufacturers on Oct. 7 regarding this issue. In the letter, HRSA asked the drug manufacturers within 30 days “to notify HRSA of plans to repay affected covered entities and to institute the offer of the discounted price in the future.” The Department of Health and Human Services and HRSA in July issued an interpretive rule that continues to allow hospitals subject to the orphan drug exclusion to purchase “orphan drugs” through the 340B program when the drugs are not used to treat the rare conditions for which the orphan drug designation was given. The Pharmaceutical Research and Manufacturers of America this month filed a lawsuit challenging the interpretative rule.

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