# Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”
> **Centers for Medicare and Medicaid Services** · Final rule. · Published 2021-01-14 · Effective 2021-03-15 · 86 FR 2987
## Document
- **Document number:** 2021-00707
- **Category:** fda-device
- **Sub-agency:** Centers for Medicare and Medicaid Services
- **Federal Register citation:** 86 FR 2987
- **CFR reference:** 42 CFR 405
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2021/01/14/2021-00707/medicare-program-medicare-coverage-of-innovative-technology-mcit-and-definition-of-reasonable-and)
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