CMS Shares 340B Claims Repository Guidance

A new FAQ page and fact sheet from the Centers for Medicare & Medicaid Services (CMS) detail key features of the upcoming voluntary claims repository for the 340B Drug Pricing Program.

In the calendar year (CY) 2026 Physician Fee Schedule (PFS) rule, CMS finalized the voluntary repository to help identify drug sales that should be excluded from manufacturer penalty calculations for price increases that exceed inflation. The CY 2027 PFS proposed rule included a provision to mandate participation in the repository for all covered entities.

The fact sheet details who can submit to the repository, how to submit data, what entities are required to participate, and submission timelines.

The FAQ describe the repository's background, account creation, potential issues with multiple 340B IDs, claims submission details, and other information. CMS encourages stakeholders with additional questions to email [email protected].

Contact Director of Policy Rob Nelb, MPH, at [email protected] or 202.585.0127 with questions.