CMS opened its Medicare Part D Claims Data 340B Repository Oct. 1 for voluntary data submissions, ahead of a proposed Jan. 1, 2027, deadline when submissions would become mandatory for 340B covered entities and their third-party administrators.
Here are four things to know:
- The repository allows covered entities to submit data elements from Part D 340B claims under the Medicare Prescription Drug Inflation Rebate Program.
- The launch lands as 340B stakeholders brace for a cluster of changes taking effect the same day the mandate would begin: 15 more Part D drugs move to negotiated Medicare prices, the CY 2027 Part D benefit redesign applies and a 340B rebate pilot is set to go live, shifting some covered entities from the program’s traditional upfront discount model to a post-sale rebate structure.
- The repository also arrives amid an ongoing standoff between drugmakers and hospitals over claims-level data more broadly. Eli Lilly and Johnson & Johnson have required covered entities to submit claims data directly to them, citing concerns about duplicate discounts under the IRA, a practice AHA and hospital groups have challenged as unlawful.
- Eleven states have enacted laws barring manufacturers from conditioning 340B pricing on claims-data submission. A centralized, CMS-run repository could offer covered entities an alternative path for compliance that does not run directly through individual manufacturers.
