Voluntary 340B Repository Data Element Reporting Requirements

[IRA Collection] Medicare Prescription Drug Inflation Rebate Program: Sections 11101 and 11102 of the Inflation Reduction Act (IRA) (CMS-10930)

CMS-10930 - PRA Disclosure Statement_clean_11.19.25docx

Voluntary 340B Repository Data Element Reporting Requirements

OMB: 0938-1485

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PRA Disclosure Statement

Medicare Prescription Drug Inflation Rebate Program under

Sections 11101 and 11102 of the Inflation Reduction Act (IRA)

(CMS-10930, OMB 0938-1485)


According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-1485 (CMS-10930). This information collection is for the Centers for Medicare & Medicaid Services (CMS) to collect information to implement regulatory requirements of Medicare Part D Drug Inflation Rebate Program as finalized in our November 5, 2025 (90 FR 49266) CY 2026 Physician Fee Schedule (PFS) final rule (CMS-1832-F, OMB 0938-AV50) and calculate a rebate amount for a manufacturer of a Part D rebatable drug if the annual manufacturer price exceeds the inflation-adjusted payment amount.


The reporting requirements are voluntary. We estimate it will take 8 hours per submission to complete this information collection. This includes the time to review instructions, search existing data resources, gather the data needed, to review and complete the information collection.


If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850.


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