Drug manufacturers are increasingly expanding claims-data requirements under the 340B Drug Pricing Program, creating new compliance and operational challenges for covered entities. In a recent article, Drug Topics examines Johnson & Johnson’s new policy requiring covered entities to submit claims data for in-house pharmacy dispensing through the 340B ESP platform. Effective September 15, 2026, the policy generally requires data submission within 45 days, with a 60-day window for certain products. Johnson & Johnson follows other manufacturers, including Exelixis and Eli Lilly, that have expanded claims-data requirements beyond traditional contract pharmacy arrangements.
Drug Topics references analysis from Benjamin Youssef regarding the growing trend of manufacturer-imposed 340B data mandates. Youssef has cautioned covered entities against waiting until discounted pricing is suspended before addressing these policies. The article points to his analysis of Eli Lilly’s expanded requirements and subsequent pricing suspensions, emphasizing the importance of developing compliance strategies early while also preserving potential legal challenges to manufacturer mandates. Covered entities navigating these rapidly evolving requirements should evaluate operational capabilities, document compliance efforts, and consider submitting written legal objections before a pricing cutoff occurs.
