Unlocking Market Access With Medicare’s New TCET Pathway

For medtech founders, navigating the regulatory landscape is often the most daunting part of bringing an innovative device to market. Enter the Transitional Coverage for Emerging Technologies (TCET) Pathway—a game-changer that every medtech entrepreneur should have on their radar. Here’s why:

1. Faster Market Access: No More Waiting in Limbo

The new TCET Pathway (released Aug. 7, 2024) is designed to speed up the process for FDA-designated Breakthrough Devices to gain Medicare coverage. Historically, device makers have found themselves stuck in a “valley of death” between FDA approval and Medicare coverage, a gap that TCET aims to bridge. The program plans to accept five device makers each year, offering a lifeline to those innovators stuck in limbo. For founders, this means less time waiting and more time selling.

2. Clarity and Confidence: Say Goodbye to Coverage Uncertainty

One of the biggest headaches for medtech startups is the uncertainty surrounding Medicare coverage. With TCET, the process is transparent and predictable, providing clear guidelines and timelines. The Centers for Medicare & Medicaid Services (CMS) has committed to offering a coverage decision within six months after FDA authorization, which is a significant improvement. This is a huge win for startups, as it allows them to plan their go-to-market strategy with more certainty, making those investor pitches that much stronger.

3. Early Engagement: Shape Your Success from the Start

The TCET Pathway isn’t just about speed—it’s about smart planning. By encouraging early engagement between device manufacturers and CMS, the pathway allows you to get feedback on the potential benefits and risks of your technology before it hits the market. This early insight can help refine your product and business model, setting you up for success from the get-go.

4. Evidence Development: Close the Gaps, Boost Your Credibility

Innovative devices often face scrutiny over evidence gaps. TCET offers a clear framework for developing the necessary clinical evidence through targeted studies. This isn’t just about meeting regulatory requirements—it’s about proving the value of your innovation to payers, providers, and patients. For founders, this can be the difference between a product that’s “nice to have” and one that’s indispensable.

5. Take Control: Proactive Self-Nomination

Perhaps one of the most empowering aspects of the TCET Pathway is the ability for companies to self-nominate their devices for consideration. This gives you the power to take control of your product’s future, aligning your regulatory strategy with your business goals and market timelines.

Historical Context: Why Now?

So, why is the government rolling out the TCET Pathway now? The answer lies in a combination of factors that have evolved over the past decade:

• Complexity of Emerging Technologies: As medical technologies have grown more complex, the traditional methods of evaluating them have struggled to keep pace. This complexity has driven the need for more adaptive and flexible processes like TCET to ensure that cutting-edge innovations can be properly assessed and integrated into the healthcare system.

• Commitment to Transparency: There has been a growing emphasis on transparency in CMS’s decision-making processes. The TCET Pathway reflects this shift, aiming to provide clear and consistent guidelines that allow manufacturers, providers, and patients to make informed decisions with confidence.

• A Response to Industry Pressure: The medical device industry has been vocal about the need for quicker Medicare coverage, with lobby groups and legislative efforts pushing CMS to accelerate the process. For example, a House committee passed a bill in June that would allocate $10 million annually to CMS specifically for breakthrough device reimbursement decisions. The TCET Pathway can be seen as a response to these pressures, offering a balanced approach that prioritizes both innovation and patient safety.

These factors together underscore why the government is actively pursuing the TCET Pathway at this time. It’s not just about speeding up market access; it’s about ensuring that the regulatory environment keeps pace with innovation while maintaining the rigorous standards necessary to protect patient safety and trust.

Why It Matters

For medtech founders, the TCET Pathway is a sign of positive change. It represents a shift toward a more supportive regulatory environment that recognizes the challenges innovators face. While it doesn’t solve every problem, TCET offers a pathway that could make it easier for groundbreaking technologies to reach the people who need them most.

In an industry where timing and trust are everything, the hope is that TCET will provide a clearer path forward—one that balances the need for innovation with the responsibility to protect patients.