Bristol-Myers Squibb (BMS) on Nov. 26 filed suit against the Health Resources and Services Administration (HRSA) to implement a 340B Drug Pricing Program rebate model. The suit makes BMS the fourth manufacturer to seek implementation of a rebate model. It follows Johnson & Johnson’s and Eli Lilly’s legal efforts to gain judicial approval for their proposed models and Sanofi’s attempt to unilaterally impose a rebate model beginning Jan. 6, 2025.
The filing — which requests an injunction against HRSA barring implementation of their model — describes how BMS would require that all covered entities purchase the drug Eliquis at commercial prices. The manufacturer argues that the complexity of complying with the Inflation Reduction Act’s Medicare drug negotiation program and the 340B program simultaneously necessitates a rebate model for those products. BMS additionally argues that statute explicitly allows a rebate and HRSA may not prohibit, nor may it require secretarial approval for, a rebate model.
BMS also states it has the capacity to provide rebate payments faster than its target window of seven to 10 days, but it is withholding statutorily mandated discounts to incentivize manufacturers to meet the manufacturer’s desired transparency requirements and uses for 340B savings.
Contact Director of Policy Rob Nelb, MPH, at rnelb@essentialhospitals.org or 202.585.0127 with questions.
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