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HHS/CMS RIN: 0938-AU28 Publication ID: Fall 2021 
Title: Medicaid Drug Misclassification, Beneficiary Access Protection, and Drug Program Administration (CMS-2434) 

This proposed rule would implement section 6 of the Medicaid Services Investment and Accountability Act of 2019, which created new penalties related to manufacturers’ misclassification of covered outpatient drug products under the Medicaid Drug Rebate Program (MDRP) including civil monetary penalties, suspension of a manufacturer’s drug, and the ability of states to recover unpaid rebates. In addition, it proposes beneficiary protections relating to access to drugs under value-based purchasing programs, as well as MDRP program integrity and administration changes.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: Pub. L. 116–16, sec. 6    42 U.S.C. 1396r-8   
Legal Deadline:  None
Action Date FR Cite
NPRM  05/00/2022 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Federal, State 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Cynthia Denemark
Deputy Director, Division of Pharmacy
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Medicaid and CHIP Services, MS: S2-14-26, 7500 Security Boulevard,
Baltimore, MD 21244
Phone:410 786-8764