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TCET Pathway Could Accelerate Access to Innovating Technologies

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 Incorporate draft guidance on endpoints and real-world data.

- Enable rapid post-market product iterations while maintaining quality.

- Develop safety monitoring and launch protocols satisfying coverage safeguards. 

- Allocate resources for robust data collection and coordination with CMS under shifted evidence requirements.

This proactive, collaborative mindset allows developers to work synergistically with regulators, accelerating patient access while still demonstrating clinical value.

TCET is designed such that it may provide key advantages for AI, machine learning and other novel developments:

- Expedited coverage following truncated registries/pragmatic studies to supplement breakthrough designation data

- Flexibility to refine algorithms and update data inputs without full regulatory restarts

- Clearer expectations and endpoints for pre-market trials to meet CMS evidence needs

- Structured opportunities for manufacturer feedback on study improvements 

- Transitional coverage with “Coverage with Evidence Development” while real-world evidence is gathered

- Streamlined reviews of new data at scheduled milestones to make updated coverage determinations

By embracing TCET’s efficiency, developers can advance high-potential technologies through the pipeline with appropriate oversight. However, challenges may remain even under TCET:

- Non-breakthrough devices still face conventional regulatory burdens

- Reluctance to cover unproven categories like digital health despite clinical promise

- Real-world implementation unknowns and long-term safety monitoring needs 

- Provider training gaps and care integration difficulties

- Ongoing patient access barriers and health disparities

While a major step forward, TCET alone cannot resolve all impediments to emerging technology adoption. Still, TCET represents the type of flexible, sensible regulation needed to balance oversight and progress. As details finalize, TCET could catalyze development of transformative innovations to improve patient outcomes.

As CMS finalizes the pathway details, I’m excited to see TCET in action opening the door to cutting-edge medical breakthroughs. The alacrity of the constantly evolving medtech landscape demands regulatory nimbleness. By embracing agility through initiatives like TCET, CMS is demonstrating an impactful commitment to progress.



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