In August 2024, the Centers for Medicare and Medicaid Services (CMS) established the Transitional Coverage for Emerging Technologies (TCET) pathway. TCET is intended to expedite national coverage for certain new technologies designated by the FDA as Breakthrough Devices. TCET leverages existing National Coverage Determination (NCD) and Coverage with Evidence Development (CED) processes to accelerate Medicare coverage for approved technologies. Medicare is the largest single healthcare purchaser in the United States and serves over 62 million beneficiaries.
Potential Benefits From Securing TCET:
Payers often have higher evidence demands than the FDA for coverage of novel medical devices; this misalignment often leads to devices entering the market with slow growth while they establish the evidence necessary to secure reimbursement.
Direct Feedback from CMS on the Evidence Development Strategy
Early CMS feedback on the technology’s evidence develop strategy can help optimize evidence generation to meet the needs of CMS and other payers.
US Market Challenges Not Changed by TCET:
TCET only impacts Medicare coverage. New procedure and/or product codes through the AMA (e.g., CPT) or CMS (e.g., HCPCS) and/or assignment of appropriate payment rates may still be required.
Commercial Payers
TCET is a Medicare-specific program and does not apply to commercial payers.
CMS Benefit Categories
TCET is not a solution for technologies that do not meet the requirements for an existing Medicare benefit category; certain technologies such as prescription digital therapeutics are still ineligible for Medicare coverage.
Contact us to learn more about how TCET impacts your technology’s US reimbursement and market access strategy. Learn more about other reimbursement pathways available for FDA Breakthrough Devices.