Eli Lilly and Co. will require all 340B covered entities to submit claims-level data for in-house pharmacy dispensing beginning Feb. 1, 2026.
The new requirement expands Lilly’s existing policy, which has applied to contract pharmacies since December 2021, according to a Jan. 15 company news release. All covered entity types must report claims-level data for Lilly’s full product portfolio — under labeler codes 00002, 00077 and 66733 — to the 340B ESP platform within 45 days of product dispense. For certain infused and administered products, data must be submitted within 60 days of administration. Those products are Alimta, Amyvid, Cyramza, Erbitux, Kisunla, Omvoh, Portrazza and Tauvid.
Entities that do not submit timely and complete data may lose access to 340B pricing until submission is resolved.
Covered entities in 10 states — Colorado, Maine, Nebraska, North Dakota, Oregon, Rhode Island, South Dakota, Tennessee, Vermont and West Virginia — are exempt from the requirement. Federally Qualified Health Centers and “look-alikes” in New Mexico are also excluded from the policy.
The policy has drawn pushback from the American Hospital Association, which urged the Health Resources and Services Administration in a Jan. 26 letter to prevent it from taking effect. The AHA called the requirements “prohibitively costly” and “unlawful,” and said they would impose significant burdens on hospitals while undermining access to 340B pricing. The group also raised concerns about the reliability of the 340B ESP platform and asked HRSA to consider civil monetary penalties against Lilly.
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