View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML
HHS/CMS RIN: 0938-AV90 Publication ID: 2026 
Title: ●Medicare Drug Price Negotiation Program (CMS-4215)(Section 610 Review) 
Abstract:

This proposed rule would codify the Medicare Drug Price Negotiation Program established in the Inflation Reduction Act. These changes would apply to the Negotiation Program effective initial price applicability year 2029.

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: No 
EO 14192 Designation: Other 
RFA Section 610 Review: Section 610 Review 
CFR Citation: 42 CFR 429   
Legal Authority: Pub. L. 117-169, Sec. 11001 and 11002    Pub. L. 119-21, Sec. 71203   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  07/00/2026 
Regulatory Flexibility Analysis Required: YES  Government Levels Affected: Federal 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Elisabeth Daniel
Director, Division of Policy
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Medicare, 7500 Security Blvd,
Baltimore, MD 21244
Phone:410 786-0549
Email: elisabeth.daniel@cms.hhs.gov