Lexology December 29, 2025
340B Covered Entities are breathing a sigh of relief in light of a court ruling that halted the 340B rebate model from taking effect at the beginning of the year. On December 29, 2025, the U.S. District Court for the District of Maine issued a ruling preventing the Health Resources and Services Administration (“HRSA”) from implementing the 340B Rebate Model Pilot Program (“Rebate Pilot Program”). The Rebate Pilot Program would have required 340B Covered Entities to purchase 340B drugs at full price and later obtain the discount through post-purchase rebates. The ruling halts the Rebate Pilot Program before its planned January 1, 2026, effective date and preserves existing 340B pricing practices while the litigation proceeds. Given the attention this program...







