(Jan. 16, 2025) – In its Jan. 12 filing with the First Circuit Court of Appeals, the U.S. Department of Health and Human Services said it plans to drop its appeal of an order blocking the 340B rebate pilot. The filing also said HHS is in discussions with the American Hospital Association about "returning the approvals challenged in this litigation to the agency for reconsideration." HHS further indicated it plans to promptly request that the Health Resources and Services Administration reconsider its approvals of the pharmaceutical manufacturer rebate plans. If the appeal is dismissed, KHA and other state hospital associations will not file an amicus brief at this time.
Although not indicated in the filing, we anticipate HRSA will attempt to reissue 340B rebate pilot guidance addressing the issues the Maine District Court, and the First Circuit Court of Appeals, found HHS likely violated in implementing the current pilot, including failure to follow the Administrative Procedures Act and inadequate consideration of harm to participating hospitals. KHA staff will continue to monitor HRSA's actions, keep our members informed and direct our advocacy efforts accordingly.
While the KHA team is pleased with this latest development, we will continue to work to protect 340B for our members at both the state and federal level. To that end, please find the latest 340B infographic. The new infographic is located in the 340B Toolkit as well.
--Karen Braman