The Centers for Medicare & Medicaid Services will launch a new Medicare Part D Claims Data 340B Repository on October 1.
The agency’s 340B data repository will be a centralized, federally managed information system that will collect, store, and process specific claim-level utilization data for prescription drugs dispensed under the Medicare Part D benefit that also are subject to discounts through the 340B Drug Pricing Program.
CMS developed the repository to support implementation of the Medicare Prescription Drug Inflation Rebate Program, which was mandated by the Inflation Reduction Act of 2022. Under this program, the federal government must exclude drug units that receive a 340B discount from the total calculations used to determine manufacturers’ inflation-based rebates.
Authorized users – 340B-covered entities, third-party administrators, and their designated reporting partners – will submit distinct, auditable data elements directly to the repository.
The repository will be launched on October 1 with a voluntary testing period designed to give safety-net providers an opportunity to test their reporting mechanisms and refine the accuracy of the data they submit. CMS has formally proposed a regulatory transition that would make data submission to the repository mandatory for 340B-covered entities starting on January 1, 2027.
Information housed by the system is designated for internal agency analysis to ensure accurate rebate calculations and will be confidential and not shared with external third parties, drug manufacturers, and commercial Part D plan sponsors.
The potential impact of the introduction of the Medicare Part D Claims Data 340B Repository is especially important to community safety-net hospitals because all such hospitals participate in the 340B program.
Learn more about the program by going here and scrolling down to “Medicare Part D Claims Data 340B Repository” and from this fact sheet and FAQs, which provide new information for future users about data submission requirements, implementation time frames, and more.
