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HHS/CMS RIN: 0938-AU28 Publication ID: Fall 2022 
Title: Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434) 

This rule proposes requirements related to manufacturers’ misclassification of covered outpatient drug products under the Medicaid Drug Rebate Program (MDRP). In addition, it proposes beneficiary protections, as well as MDRP program integrity and administration changes.

Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 42 CFR 433    42 CFR 438    42 CFR 447   
Legal Authority: Pub. L. 116–16, sec. 6    42 U.S.C. 1396r-8   
Legal Deadline:  None
Action Date FR Cite
NPRM  02/00/2023 
Regulatory Flexibility Analysis Required: No  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