HRSA asks drug manufacturers to refund 340B overcharges

The federal government is not abandoning hospitals on the 340B orphan drug issue. The Health Resources and Services Administration had decided that orphan drugs--often pricey medications used to treat rare diseases--should be provided in some instances to hospitals that participate in the 340B program at its permitted discount, according to AHA News Now.

Such drugs are available through the 340B program to free-standing cancer hospitals, critical access hospitals, rural referral centers and sole community hospitals.

The HRSA notified the drug manufacturers of its opinion in a letter sent to about 50 drug such companies last month. The agency's letter asked that 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," according to AHA News Now. The sum under dispute regarding the orphan drugs previously sold to providers is unknown.

The HRSA concluded in the interpretative rule it issued earlier this year that the pharmaceutical manufacturers should offer orphan drugs at the 340B discount rate if they are being used for off-label purposes: to treat patients for whom the drug was not originally designed. The HRSA said it issued the rule to provide greater clarity for the market, as well as keep the financial incentive intact for the pharmaceutical sector to continue to manufacture the drug. Hospitals cannot purchase orphan drugs through the 340B program if they purchase them for their specific purpose.

However, the primary lobby for the drug industry--the Pharmaceutical Research and Manufacturers of America--also filed suit in federal court this month, asking that the interpretive rule be thrown out. It had previously won a court ruling that allowed it to sell the drugs at full price if they're being used for their designated purpose.

To learn more:
- read the AHA News Now article