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HHS/CMS RIN: 0938-AU28 Publication ID: Spring 2020 
Title: ●Misclassification of Drugs Under the Medicaid Drug Rebate Program (CMS-2434) 

This proposed rule would implement section 6 of the Medicaid Services Investment and Accountability Act of 2019, which clarifies the definitions for single source drug, innovator multiple source drug, and multiple source drug. It would propose additional penalty and compliance authorities with respect to manufacturers that have misclassified a drug product or misreported information about their drugs to the Medicaid Drug Rebate Program.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
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  02/00/2021 
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