Eli Lilly has announced a major policy change for participants in the 340B Drug Pricing Program, effective February 1, 2026. Moving forward, covered entities will be required to submit claims data for all Lilly drugs dispensed through in‑house pharmacies – a requirement that previously applied only to contract pharmacies. Under the new policy, covered entities must submit claims through the 340B ESP platform within 45–60 days after dispensing (timing varies by product). Lilly warns that delayed or incomplete submissions may result in loss of access to 340B pricing until outstanding data is provided. Some states remain exempt due to existing laws, these states include: CO, ME, NE, NM (FQHCs only), ND, OR, RI, SD, TN, VT, and WV.
Lilly says this expanded requirement is aimed at curbing 340B program abuse, such as double discounting, and supporting the company’s ability to conduct audits. However, the policy has already drawn strong pushback. This shift signals increasing scrutiny of 340B operations and could reshape the compliance landscape for covered entities heading into 2026.
