View Rule

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.

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.

Alternatives:

Not yet determined.

Anticipated Costs and Benefits:

Not yet determined.

Risks:

Not yet determined.