AMC Joins Amicus Briefs Urging Court to Block 340B Rebate Models    

The AAMC over the past week joined the American Hospital Association, Children’s Hospital Association, and America’s Essential Hospitals to file amicus briefs (PDF) in several lawsuits in the U.S. District Court for the District of Columbia urging the court to uphold the Health Resource and Services Administration’s (HRSA’s) decision to prevent drug manufacturers from replacing upfront 340B discounts with back-end rebates. 

Johson & Johnson was the first drug company to propose a 340B rebate model, and HRSA warned the company that it would be subject to steep fines and loss of Medicaid and Medicare Part B coverage for its drugs if it proceeded with its model [refer to Washington Highlights, Sept. 20, 2024]. Johnson & Johnson suspended its rebate model plans and filed a lawsuit over the dispute [refer to Washington Highlights, Oct. 4, 2024, Nov. 14, 2024]. Subsequently, four additional companies (Bristol Myers Squibb, Eli Lilly, Novartis, and Sanofi) also sued HRSA in the same court seeking to impose rebate models. 

The briefs explain that “the rebate policy will require hospitals and other covered entities to float significant sums to J&J and other drug companies,” highlighting the negative impacts of these policies on 340B-covered entities and the patients they serve. The briefs argue that “Drug companies may be dissatisfied with that law or how the Executive Branch is enforcing it, but that does not permit J&J or other drug companies to try to enforce the law itself.”