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HHS/CMS RIN: 0938-AT88 Publication ID: Fall 2020 
Title: Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary" (CMS-3372) 
Abstract:

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.

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: No 
EO 13771 Designation: Other 
CFR Citation: 42 CFR 405   
Legal Authority: 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)   
Legal Deadline:
Action Source Description Date
Final  Statutory  MMA sec. 902 requires Medicare final rules publish within 3 years of a proposed or interim final rule.  09/01/2023 

Overall Description of Deadline: 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.

Timetable:
Action Date FR Cite
NPRM  09/01/2020  85 FR 54327   
NPRM Comment Period End  11/02/2020 
Final Action  09/00/2023 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Linda Gousis
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Clinical Standards and Quality, MS: C1-26-12, 7500 Security Boulevard,
Baltimore, MD 21244
Phone:410 786-8616
Email: linda.gousis@cms.hhs.gov