On December 29, 2025, a federal judge granted a preliminary injunction blocking HRSA from implementing the 340B Rebate Model Pilot Program. As a result, the rebate model will not go into effect on January 1, 2026, and the current 340B upfront pricing structure remains in place for now.
The court determined that HRSA likely did not meet required administrative standards in rolling out the program, particularly around evaluating hospital reliance on upfront 340B discounts and the financial and operational impact of a rebate-based approach. This injunction pauses implementation until further court order. While the government is expected to appeal, the injunction remains effective unless a higher court lifts it.
We are continuing to monitor developments closely and will keep you informed of any changes that would impact operations or planning. Please reach out if you have questions or would like to discuss what this means for your program specifically.
