TCET—A Medicare Coverage Option for Breakthrough Devices

Why It Matters

For many device makers, the biggest commercial hurdle isn’t FDA authorization—it’s the long wait for Medicare to decide on coverage. Historically, the gap between FDA market authorization and a National Coverage Determination (NCD) has stretched several years, delaying access for seniors and slowing commercial adoption.

The Transitional Coverage for Emerging Technologies (TCET) pathway, finalized by CMS in August 2024, is a new voluntary process designed to close that gap. It applies to FDA-designated Breakthrough Devices and seeks to align regulatory and reimbursement timelines, giving manufacturers more predictability and patients earlier access.

"Early engagement under TCET is essential," says Katy Herman, Associate Attorney at Gardner Law. "By aligning your evidence development plan with Medicare’s coverage requirements before FDA authorization, you can avoid costly reimbursement missteps and keep your launch on track. We help companies design coverage strategies that not only accelerate access but also meet compliance obligations every step of the way."

What Is TCET?

TCET replaces CMS’s earlier “MCIT” (Medicare Coverage of Innovative Technology) proposal, which was rescinded in 2021. Where MCIT would have automatically covered all Breakthrough Devices for four years, TCET takes a more tailored approach, requiring early engagement, structured evidence planning, and a defined transition to permanent coverage decisions.

The goal: make coverage decisions faster, while ensuring that Medicare beneficiaries get access to safe, effective, and well-supported technologies.

Key Features You Should Know

1. Eligibility
CMS intends to accept only 3–5 devices into the TCET pathway each year, making early, well-prepared submissions critical. Additionally, your device must:

• Hold FDA Breakthrough Device designation

• Fit a Medicare benefit category

• Not already have an NCD or be excluded by statute/regulation

2. Early Engagement Pays Off

• Letter of Intent: 18–24 months before expected FDA authorization

• Formal Nomination: ≈12 months before anticipated authorization

Nominations are reviewed quarterly, with the next deadline on October 31, 2025.

3. Evidence Preview—Know the Gaps Before Approval
CMS will review your existing evidence, flag data gaps, and may consult its advisory committee (MEDCAC) on endpoints. This is a chance to align your clinical and real-world evidence strategy with coverage expectations before launch.

4. Evidence Development Plan (EDP)
If gaps exist, you’ll co-develop an EDP with CMS, often including real-world evidence collection. Coverage can run for up to 5 years while you generate the needed data.

5. Faster Coverage Timeline
Once FDA clears or approves your device, CMS aims to issue an NCD within 6 months, which is significantly shorter than historic timelines.

6. “Equity” Coverage
Similar Breakthrough Devices may also receive comparable TCET coverage, but must independently meet all eligibility criteria and complete their own EDP.

Practical Takeaways for Device Makers

• Start Early: Backward-plan from anticipated FDA authorization to hit the LOI and nomination windows.
• Align Regulatory & Market Access Teams: Coordinate FDA and CMS strategies to avoid evidence surprises.
• Budget for Evidence Generation: TCET can give you coverage earlier, but you must deliver on your EDP.
• Track Similar Devices: Competitors’ TCET outcomes may set precedents relevant to your product.

Contact Gardner Law

Contact Gardner Law to discuss how our reimbursement team can help you align your TCET strategy with long-term Medicare coverage goals, ensuring early wins translate into sustained market access without regulatory surprises.