0938-AT88 202110 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0938 Centers for Medicare & Medicaid Services CMS 0900 Department of Health and Human Services HHS Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary" (CMS-3372)

This rule established a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA). It also finalized regulatory standards to be used in making reasonable and necessary determinations under section 1862(a)(1)(A) of the Social Security Act (the Act) for items and services that are furnished under Part A and Part B.

]]> Economically Significant Previously Published in The Unified Agenda Completed Actions Yes No 42 CFR 405 42 U.S.C. 263a 42 U.S.C. 405(a) 42 U.S.C. 1302 42 U.S.C. 1320b-12 42 U.S.C. 1395x 42 U.S.C. 1395y(a) 42 U.S.C. 1395ff 42 U.S.C. 1395hh 42 U.S.C. 1395kk 42 U.S.C. 1395rr 42 U.S.C. 1395ww(k) Statutory Final 09/15/2024 MMA sec. 902 requires Medicare final rules publish within 3 years of a proposed or interim final rule. Per the CMS notice published December 30, 2004 (69 FR 78442), except for certain Medicare payment regulations and certain other statutorily-mandated regulations, we schedule all Medicare final regulations for publication within the 3-year standardized time limit in the current Unified Agenda. We do not intend to delay publishing a Medicare final regulation for 3 years if we are able to publish it sooner. No NPRM 09/01/2020 85 FR 54327 NPRM Comment Period End 11/02/2020 Final Action 01/14/2021 86 FR 2987 Interim Final Rule-Delay in Effective Date 03/17/2021 86 FR 14542 Interim Final Rule Comment Period End 04/16/2021 2nd Final Action--Delay in Effective Date 05/18/2021 86 FR 26849 Final Action Effective 12/15/2021 2nd NPRM 09/15/2021 86 FR 51326 2nd NPRM Comment Period End 10/15/2021 Final Action 11/15/2021 86 FR 62944 Final Action Effective 12/15/2021 No Federal No No No Linda Gousis Health Insurance Specialist 0938 Centers for Medicare & Medicaid Services CMS 410 786-8616 linda.gousis@cms.hhs.gov Center for Clinical Standards and Quality, MS: C1-26-12, 7500 Security Boulevard, Baltimore MD 21244