HRSA has updated its Office of Pharmacy Affairs website to confirm that it is pausing implementation of the 340B Rebate Model Pilot Program while litigation continues, following a January 29th federal court order blocking the pilot from moving forward. The pause stems from a preliminary injunction issued by the U.S. District Court for the District of Maine, which concluded that the rebate pilot raised significant procedural concerns and therefore could not proceed as planned for the January 1st start date. The update comes after the Department of Health and Human Services appealed that decision and sought an emergency stay and on January 31st the U.S. Court of Appeals for the First Circuit declined to lift the injunction. The court stated that it intends to resolve the appeal on an expedited timeline. For now, HRSA emphasized that it will maintain the existing 340B pricing structure and will provide further updates as the litigation progresses.

Ready for expert guidance on your 340B program based on the latest industry events? Contact us today to learn how we can support your entity's success.

Why This Matters:

The pause on the 340B rebate pilot preserves the existing drug pricing structure for covered entities and manufacturers while the courts determine whether HHS has the authority to fundamentally change how the 340B program operates.