The Department of Health and Human Services (HHS), in a Feb. 5 legal filing, told the U.S. District Court for the District of Maine that it would fully withdraw its proposed rebate pilot for the 340B Drug Pricing Program. HHS agreed to vacate the program as it currently exists while the agency considers whether to pursue a new administrative process.
This decision follows the District Court’s issuance of a temporary injunction on Dec. 29, 2025, prohibiting the rebate pilot from taking effect. After an initial appeal to the U.S. Court of Appeals for the First Circuit was rejected and HHS subsequently withdrew its appeal, the District Court continued to consider the case. America’s Essential Hospitals submitted friend-of-the-court briefs with both the District Court for the District of Maine and the First Circuit Court of Appeals, urging the government to block the rebate pilot.
In its filing, HHS concluded that further litigation “would not be fruitful.” The agency stated it will withdraw all existing guidance related to the pilot, including the program application notice and all previously approved rebate program applications from manufacturers.
HHS also pledged that if it moves forward with a new rebate program in the future, it will do so through a new administrative process. That process would include issuing a new notice with an opportunity for public comment, as well as providing a minimum of 90 days between rebate plan approval and implementation.
Contact Director of Policy Rob Nelb, MPH, at rnelb@essentialhospitals.org or 202.585.0127 with questions.
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