0938-AT82 202104 Unified Agenda of Federal Regulatory and Deregulatory Actions 0938 Centers for Medicare & Medicaid Services CMS 0900 Department of Health and Human Services HHS 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.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No 42 CFR 433 42 CFR 438 42 CFR 447 42 CFR 456 42 U.S.C. 1302 and 1396r-8 No 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 No Federal State No No No Wendy Tuttle Health Insurance Specialist 0938 Centers for Medicare & Medicaid Services CMS 410 786-8690 wendy.tuttle@cms.hhs.gov S1-01-16, Center for Medicaid and CHIP Services, MS: S2-14-26, 7500 Security Boulevard, Baltimore MD 21244