A federal judge has largely sided with the U.S. Department of Health and Human Services in a high-stakes legal battle over proposed changes to the 340B Drug Pricing Program, dealing a significant blow to pharmaceutical companies seeking to implement rebate models for discounted medications.
Judge Dabney L. Friedrich of the U.S. District Court for the District of Columbia ruled Thursday that the Health Resources and Services Administration (HRSA) did not act illegally when it denied proposals from Bristol Myers Squibb Co., Novartis AG, Eli Lilly & Co., and Sanofi SA to fundamentally alter how they provide discounts to healthcare providers serving low-income and uninsured patients.
Court Upholds Agency Authority
The ruling addresses a complex dispute that emerged after pharmaceutical manufacturers began pushing for rebate models following passage of the Inflation Reduction Act. Under current 340B program rules, covered entities purchase drugs at steep discounts upfront. The proposed rebate models would require providers to pay commercial prices initially, then submit data to receive rebates later.
"To date, HRSA has not finally rejected Lilly, BMS, or Novartis's proposals—rather, it has informed those manufacturers that it cannot 'approve or disapprove' their rebate models 'to date,'" Friedrich wrote in her order, which grants and denies in part the government's cross motions for summary judgment.
The judge acknowledged the competing pressures facing the agency, noting that HRSA "asserts that it needs longer to complete its review of the varied proposals manufacturers began submitting in July of 2024, which represent a large-scale shift in the way the 340B program has operated for three decades."
Partial Victory for Sanofi
While the court largely favored the government's position, it provided some relief to Sanofi regarding the company's distinct "credit model" proposal. Unlike other manufacturers' rebate schemes, Sanofi's model would offer rebates in the form of credits that become effective before providers' bills are due.
Friedrich ruled that HRSA made a final decision on Sanofi's proposal but "failed to provide a reasoned explanation for disregarding concerns about duplications and diversions under the plan." The court vacated portions of HRSA's violation letter to Sanofi and remanded the matter back to the agency for further consideration.
"While we are disappointed in the court's decision overall, we appreciate that the opinion recognized that the 340B program is rife with abuse," a Sanofi spokesperson said in a statement. "We also applaud the court for ordering that HRSA address some of these flaws raised by Sanofi when reconsidering our 340B Credit Model."
Industry Reactions and Compliance Concerns
Pharmaceutical companies have argued that rebate models would bring greater transparency to the 340B program and help prevent duplicate discounts, particularly in light of obligations under the Inflation Reduction Act's Medicare Drug Price Negotiation Program.
A Novartis spokesperson indicated the company plans to seek further review, stating that "the use of a cash-rebate model is expressly allowed in the 340B statute and would help uphold critical statutory protections against duplicate discounts while maintaining timely access to 340B pricing."
Eli Lilly expressed satisfaction that the court found the 340B statute "explicitly contemplates" rebate models and that HRSA must evaluate manufacturers' proposals while addressing their "valid concerns" about widespread program abuses.
Bristol Myers Squibb announced plans to appeal the decision but noted appreciation that the court asked HRSA to continue reviewing duplication and diversion issues in the program.
Hospital Concerns Over Administrative Burden
Healthcare providers and their advocates have strongly opposed rebate models, citing significant administrative and financial concerns. UMass Memorial Medical Center estimated that compliance with one manufacturer's proposed rebate model would require diverting nearly $400,000 from its annual operating budget.
"On behalf of our more than 1,600 hospital members, we are pleased this opinion recognizes the immense harm unilateral drugmaker rebate schemes would cause safety-net hospitals and the patients in need whom they serve," stated 340B Health, a provider advocacy group that intervened in the case.
The organization emphasized that rebates would force hospitals to spend "hundreds of millions of dollars on drug-carrying costs, additional staff resources and other expenses for complying with drugmaker rebate mandates."
Regulatory Uncertainty Ahead
The court ruling comes amid broader uncertainty about the 340B program's future under the Trump administration. Plans call for HRSA to cease existing as a standalone agency, with 340B oversight transferring to the Centers for Medicare & Medicaid Services.
Judge Friedrich raised concerns about coordination between agencies, particularly regarding the intersection of the 340B program and Medicare's drug price negotiation plan. "Although HRSA represents that it plans to 'coordinate ... [with CMS] to provide and share information to support compliance with each agency's respective program requirements,' the absence of a definitive oversight plan to date is concerning," she wrote.
HRSA indicated to the court in May that it planned to provide additional guidance on rebate proposals within 30 days, though the agency has since submitted new regulatory guidance to the Office of Management and Budget for review, with details not yet public.
The 340B Drug Pricing Program requires manufacturers to provide discounts on medications to qualifying hospitals, clinics, and providers that treat disproportionate numbers of low-income and uninsured patients. The program has faced ongoing scrutiny over its integrity and how discounts are utilized, making the court's decision particularly significant for the healthcare industry's approach to serving vulnerable patient populations.
