New manufacturer communications indicate an important shift in how 340B-priced drugs may be accessed going forward. Letters issued by Eli Lilly and Company and Pfizer Inc. reflect an increased emphasis on claims-level data submission as a condition of 340B access.
As the timeline of a HRSA rebate pilot remains uncertain, manufacturers seem to be reassessing data transparency expectations and the distinction between contract pharmacy and in-house dispensing models may become less clear.
On February 2, Pfizer issued a notice outlining updates effective March 31, 2026. Pfizer’s update requires a new attestation that the entity has no entity-owned pharmacy, validation of current contract pharmacy arrangements, and requires claims data submission for continued access to 340B pricing at the contract pharmacy setting.
In a January, Eli Lilly and Company announced an expansion of its oversight requirements for the 340B Drug Pricing Program. Effective February 1, Lilly will require covered entities to submit claims-level data for all 340B dispenses, including those from in-house pharmacies. Lilly stated in the notice that the submitted data will be used to evaluate potential duplicate discounts and, “other 340B Program abuses”.
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Although the operational requirements differ, both letters reflect a consistent approach that claims data submission is now central to the manufacturers’ 340B access policies. This may signal the broader shift toward manufacturer-driven oversight that may continue to expand.
Finally, while HRSA has temporarily removed implementation of the proposed 340B rebate pilot, it has started laying the groundwork for approval of a revised or alternative approach in the future. On February 6, 2026, HHS/HRSA submitted a pre-rule posting for regulatory review titled “340B Drug Pricing Program Manufacturer Rebate Models.” At this time, no regulatory text or additional details regarding the substance or timeline of a potential rule have been released.
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Why This Matters:
These developments could have significant operational and compliance implications for covered entities. If claims data submission is increasingly required across dispensing models, it may introduce greater administrative complexity, tighter timelines, and reliance on manufacturer-designated platforms to maintain 340B access.