Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”
fda-device · Centers for Medicare and Medicaid Services · Rule · Published 2021-01-14 · Effective 2021-03-15 · 86 FR 2987
Document
Document number
2021-00707
Federal Register citation
86 FR 2987
CFR reference
42 CFR 405
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Centers for Medicare and Medicaid Services
Publication date
2021-01-14
Effective date
2021-03-15
HHS docket
CMS-3372-F
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). The Medicare Coverage of Innovative Technology (MCIT) pathway will result in 4 years of national Medicare coverage starting on the date of FDA market authorization or a manufacturer chosen date within 2 years thereafter. This rule also implements 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.