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HHS/CMS RIN: 0938-AU86 Publication ID: Fall 2022 
Title: Transitional Coverage for Emerging Technologies (CMS-3421) 

This proposed rule would establish the criteria for an expedited coverage pathway to provide Medicare beneficiaries with faster access to innovative and beneficial technologies. This pathway would build off of prior initiatives, including coverage with evidence development. The proposed rule will meet the following principles previously published by CMS:
1) Manufacturers may enter the process on a voluntary basis. This process will be limited to medical devices that fall within the Medicare statute and that are relevant to the Medicare population.
2) CMS may conduct early evidence review (before the device secures FDA marking authorization) and discuss with the manufacturer the best Medicare coverage pathway, depending upon the strength of the evidence collected.
3) At the manufacturer’s request, CMS may initiate the coverage process before FDA market authorization, which could require developing an additional evidence development plan and confirming that there are appropriate safeguards and protections for Medicare beneficiaries.
4) If CMS determines that further evidence development is the best coverage pathway, the agency would explore how to reduce the burden on manufactures, clinicians and patients while maintaining rigorous evidence requirements.

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: Undetermined 
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    ...   
Legal Deadline:  None

Statement of Need:

This rule is necessary to codify the Coverage with Evidence Development (CED) coverage pathway in regulation and aims to incresase predictability, transparency, and timeliness of Transitional Coverage for Emerging Technologies (TCET).

Summary of the Legal Basis:

This rule would be proposed under the authority of sections 1862(a)(1)(A) and 1862(a)(1)(E) of the Social Security Act.


Not yet determined.

Anticipated Costs and Benefits:

Not yet determined.


Not yet determined.

Action Date FR Cite
NPRM  04/00/2023 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal, State 
Small Entities Affected: Businesses, Governmental Jurisdictions  Federalism: Undetermined 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: Yes 
Agency Contact:
Lori Ashby
Senior Technical Advisor
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Clinical Standards and Quality, MS: S3-02-01, 7500 Security Boulevard,
Baltimore, MD 21244
Phone:410 786-6322