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On January 15, 2026, Eli Lilly announced an expansion of its 340B Claims-Level Data (CLD) submission requirements.
Beginning with dispenses on or after February 1, 2026, covered entities will be required to submit claims-level data for all 340B dispenses, including in-house pharmacy dispenses and medical claims.
Since 2021, Lilly has required CLD submission for contract pharmacy dispenses. This latest update expands that requirement to include in-house dispensing as well.
While the announcement is straightforward, the operational implications are important. Here’s what is changing, and what covered entities should review now.
Eli Lilly and Company will now require covered entities to submit CLD for:
This applies to Lilly’s full product portfolio under labeler codes:
Data must be submitted through the 340B ESP™ platform
Lilly has stated that failure to submit timely, complete, and accurate data may result in loss of access to 340B pricing until the outstanding data is provided.
Lilly’s Contract Pharmacy Limited Distribution System remains in place and unchanged. Distribution of 340B ceiling-priced product continues to be limited to covered entities and their child sites, subject to Lilly’s existing policy.
This update does not expand contract pharmacy access. It expands data submission requirements.
According to Lilly, claims-level data provides transparency into:
Since 2021, CLD submission for contract pharmacies has become standard practice across much of the industry. Lilly is now extending that same expectation to in-house dispensing and medical claims.
At this time, covered entities located in the following states are exempt from the CLD requirement:
Colorado
Maine
Nebraska
North Dakota
Oregon
Rhode Island
South Dakota
Tennessee
Vermont
West Virginia
Additionally, FQHCs and FQHC look-alikes located in New Mexico are exempt.
Lilly has reserved the right to revise exemptions at any time.
For entities already submitting CLD for both contract and in-house dispensing, this change may not require significant adjustment beyond continuing timely submission.
For others, this may require:
The most important takeaway: this is no longer limited to contract pharmacy oversight. In-house dispensing and medical claims are now included.
For many organizations, that means reviewing whether internal controls and staffing capacity are aligned with this expanded reporting expectation.
In light of the recent Eli Lilly changes, we are taking a structured, operational approach.
We are continuing ESP submissions without interruption to ensure reporting remains consistent and defensible. At the same time, we are reviewing data extracts and working alongside TPAs to ensure accurate reports are available for submissions as the Eli Lilly requirements for medical claims are different than the in-house.
