With the HRSA 340B Rebate Pilot temporarily on hold pending litigation, Eli Lilly and Company is expanding its efforts for 340B claims oversight. Effective February 1, 2026, Lilly will require claims-level data (CLD) submission for all 340B dispenses, including those from in-house pharmacies, as a condition of continued access to Lilly drugs at the 340B ceiling price. Data must be submitted through 340B ESP within 45 days of dispensing, with noncompliance potentially resulting in temporary suspension of 340B pricing access until the data is provided. A few drugs will allow for 60 days submission timeline.
In the notice, Lilly states that the submitted data will be used “to evaluate for duplicate discounts and other 340B Program abuses,” making clear that this requirement is intended to support manufacturer oversight and compliance monitoring—not simply administrative reporting.
This policy reinforces a broader industry direction: manufacturers increasingly view claims-level transparency as a prerequisite for 340B access, even for in-house dispensing. If other drug makers follow Lilly’s lead, covered entities should anticipate expanded reporting requirements, greater reliance on third-party platforms like ESP, and increased operational complexity to maintain 340B pricing.
Note, this requirement does not apply to covered entities located in Colorado, Maine, Nebraska, North Dakota, Oregon, Rhode Island, South Dakota, Tennessee, Vermont, or West Virginia, nor to Community Health Centers (CHCs) in New Mexico.
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Read the full policy
https://340besp.com/resources/eli_lilly/in_house_policy.pdf
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Why This Matters:
For covered entities, this development means the 340B rebate pilot is effectively paused, reducing near-term operational and cash-flow risk, but leaving ongoing uncertainty as HHS reconsiders whether, and how, the program could move forward in a revised form.