The Centers for Medicare & Medicaid Services (CMS) proposed the Transitional Coverage for Emerging Technologies (TCET) pathway to enable quicker coverage decisions for breakthrough devices needing accelerated regulatory review. As described in JAMA Health Forum, TCET allows tailored oversight based on an innovation’s specific benefits and risks. TCET focuses on FDA Breakthrough-designated devices for serious conditions supported by limited clinical data for market authorization. By facilitating transitional coverage, TCET aims to help make cutting-edge technologies accessible to patients while additional real-world evidence is gathered to meet CMS’ “reasonable and necessary” standard. For developers to optimize TCET’s streamlined approach they should be sure to: - Pursue FDA Breakthrough designation when criteria are met. This opens the TCET pathway. - Engage CMS early on study designs and evidence needs. Incorporate draft guidance on endpoints and real-world data....
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