0938-AT88 202010 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 final rule establishes 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). We are also finalizing 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 Proposed Rule Stage Yes No Other 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 09/01/2023 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 09/00/2023 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