*CMS TCET (Transitional Coverage for Emerging Technologies) _ CMS-3421-FN)

The TCET (Transitional Coverage for Emerging Technologies) pathway, finalized by CMS in August 2024, targets select FDA-designated Breakthrough Devices to expedite Medicare coverage. cms

Key Mechanism

It leverages existing NCD (National Coverage Determination) and Coverage with Evidence Development (CED) frameworks, aiming for NCD finalization within six months of FDA marketing authorization. advisory.avalerehealth

NCD Impact

CMS explicitly states that TCET increases the annual number of NCDs conducted, as it prioritizes up to five eligible devices yearly while maintaining evidence safeguards for Medicare beneficiaries. ncmedsoc

Eligibility Limits

Devices must be FDA Breakthrough-designated, fit a Medicare benefit category (excluding most digital therapeutics), lack prior NCDs, and not be statutorily excluded. cms