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HHS/CMS RIN: 0938-AT82 Publication ID: Spring 2021 
Title: Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value Based Payments (VBP) for Drugs Covered in Medicaid (CMS-2482) 

This rule proposes to delay the January 1, 2022, effective date for amendatory instruction 10.a., which addresses the reporting by manufacturers of multiple best prices connected to a value based purchasing arrangement, of the final rule entitled, Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements”, published on December 31, 2020.  This rule also proposes to delay the April 1, 2022, effective date of the amended regulatory definitions of States” and United States” to include the U.S. territories (American Samoa, Northern Mariana Islands, Guam, Puerto Rico, and the Virgin Islands) for purposes of the Medicaid Drug Rebate Program (MDRP), adopted in the interim final rule with comment period entitled, "Medicaid Program; Covered Outpatient Drug; Further Delay of Inclusion of Territories in Definitions of States and United States”, published on November 25, 2019.

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: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 433    42 CFR 438    42 CFR 447    42 CFR 456   
Legal Authority: 42 U.S.C. 1302 and 1396r-8   
Legal Deadline:  None
Action Date FR Cite
NPRM  06/19/2020  85 FR 37256   
NPRM Comment Period End  07/20/2020 
Final Action  12/31/2020  85 FR 87000   
Final Action Effective  03/01/2021 
Proposal to Delay Selected January 2022 Provision Effective Dates  05/00/2021 
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:
Wendy Tuttle
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S1-01-16, Center for Medicaid and CHIP Services, MS: S2-14-26, 7500 Security Boulevard,
Baltimore, MD 21244
Phone:410 786-8690