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HHS/CMS | RIN: 0938-AT88 | Publication ID: Fall 2021 |
Title: Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary" (CMS-3372) | |
Abstract:
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. |
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Agency: Department of Health and Human Services(HHS) | Priority: Economically Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Completed Actions |
Major: Yes | Unfunded Mandates: No |
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:
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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. |
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Timetable:
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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 |