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The Department of Health and Human Services said its decision to prevent drug companies from implementing a 340B rebate model “was within its statutory authority,” according to a department filed March 17 with the U.S. District Court for the District of Columbia. In addition, the brief said the drug companies’ “proposed cash rebate models would have upended the way the 340B Program has operated for more than thirty years” and the agency’s decision to prevent the models from being implemented was “not arbitrary and capricious.” 

The HHS brief is in cases brought by Eli Lilly, Bristol Meyers Squibb and Novartis.

The AHA March 4 filed a friend-of-the-court brief in support of HHS, saying, “The 340B statute does not permit drug companies to unilaterally withhold discounts from 340B hospitals in exchange for the surrender of purchase data or what are, in essence, pre-payment audits. The Health Resources and Services Administration therefore correctly exercised its statutory authority to reject the rebate policies.” Others joining the AHA in that friend-of-the-court brief were the Children’s Hospital Association, the Association of American Medical Colleges and America’s Essential Hospitals.

The AHA and other groups have filed friend-of-the-court briefs supporting HHS in other 340B rebate model cases brought by Sanofi, Kalderos and Johnson & Johnson.