Legal
Federal Court Decertifies 11 Clinics from 340B Program in Drugmaker Lawsuit
A federal district court in Washington, D.C. granted partial summary judgment to drugmakers including Amgen and Genentech on August 14, 2026, ordering 11 clinics' 340B certifications set aside for failing to meet statutory participation requirements. The ruling addresses longstanding disputes between drugmakers and covered entities over 340B program eligibility. The decision affects clinic access to discounted drugs under the 340B program and may signal stricter judicial scrutiny of covered entity qualifications.
Why it mattersMedicaid managed care organizations and FQHCs participating in 340B must reassess clinic eligibility criteria, as stricter judicial enforcement of statutory requirements could disrupt pharmacy benefit arrangements and contract pharmacy networks.