1/16/2026 – Eli Lilly Announces Covered Entities Must Submit Claims Data for All of Its Products

Pharmaceutical manufacturer Eli Lilly announced that, effective February 1, all covered entities must submit claims-level data for “all dispenses,” regardless of whether an entity uses contract pharmacies. Lilly warns that, if a covered entity fails to provide timely, complete, and accurate data for all 340B dispenses, the company may cancel 340B pricing for the entity. This policy is the most far-reaching and potentially punitive data submission requirement imposed by the drug industry on covered entities to date.

While many manufacturers have required covered entities to submit claims data to access contract pharmacies, Lilly is the first manufacturer to require data submission, regardless of whether an entity uses a contract pharmacy. Lilly said it is instituting the policy to “help identify the full universe of duplicate discounts and other program abuses, preserve [its] ability to initiate audits, and expand transparency even further.

Lilly directs covered entities that are not already submitting claims data to access contract pharmacies to contact www.340BESP.com to register and set up the claims submission process. Entities must submit claim data for all products manufactured under labeler codes 00002, 00077, and 66733 within 45 days of dispense, except for the following products for which entities must submit data within 60 days of product administration: Alimta, Amyvid, Cyramza, Erbitux, Kisunla, Omvoh, Portrazza, and Tauvid.

The new policy does not apply to covered entities in Colorado, Maine, Nebraska, North Dakota, Oregon, Rhode Island, South Dakota, Tennessee, Vermont, and West Virginia. FQHCs and FQHC “look-alikes” in New Mexico are also exempt from the policy.

Though Lilly does not directly market any of the ten drugs that have been subject to Medicare price negotiations under the Inflation Reduction Act (IRA) since January 1, it has an agreement with manufacturer Boehringer Ingelheim to market the drugs Jardiance and Tradjenta. Jardiance has a Medicare maximum fair price (MFP) in 2026, and Tradjenta will in 2027. The pause of HRSA’s Rebate Model Pilot could be causing manufacturers to examine other ways to receive 340B claims data. While Lilly’s policy does not address the IRA or the rebate pilot, the company’s decision to adopt this new policy may be in response to the pause. If so, Lilly’s approach is substantially broader than necessary given that only one of the company’s drugs is currently subject to MFP. Lilly’s policy may be appealing to the other manufacturers of drugs subject to MFP.

Powers will continue to monitor developments on drug manufacturer policies. Please contact Powers’ drug pricing team, or your lead Powers attorney, if you have any questions.