HHS has filed a legal brief urging a federal judge to dismiss lawsuits brought by pharmaceutical companies challenging the agency’s stance on 340B rebate models.
Here are four takeaways:
- In the brief, HHS argued that the rebate-based pricing models proposed by drugmakers violate the 340B statute which requires upfront reimbursements. The agency stated that the models undermine the program’s purpose and create administrative burdens for hospitals that rely on 340B discounts.
- Eli Lilly, Novartis and Bristol Myers Squibb have each proposed rebate-based models that require hospitals to pay full price upfront and later seek reimbursement, according to March 17 court documents obtained by Becker’s. The drugmakers argue that the models increase transparency and ensure that savings benefit patients.
- This also comes after Sanofi notified 340B entities in November that it would roll out a new credit model in early 2025. In December, the HRSA sent Sanofi a warning letter urging the drugmaker to halt its 340B rebate model.
- Drugmakers have since filed lawsuits against HHS and HRSA seeking court rulings that their rebate models comply with federal law and blocking potential enforcement actions.
