US MedTech's Money Maze: Pure Global on New CMS Rules

About this episode

This episode discusses the new TCET pathway and its implications for MedTech manufacturers regarding insurance coverage and commercialization timelines.

Last week, the US FDA and CMS announced the TCET pathway, a landmark program to accelerate insurance coverage for innovative medical devices. This move aims to eliminate the notorious "valley of death" where approved devices fail to secure reimbursement, but it also creates new strategic challenges for MedTech manufacturers. This episode of MedTech Global Insights dives into the specifics of this new policy. We analyze how it fundamentally changes the commercialization timeline and what companies must do to capitalize on this opportunity while avoiding the potential pitfalls of early market access. **Featured Case:** Imagine your AI diagnostic software just received FDA Breakthrough Designation. Historically, you'd face another 12-18 months of uncertainty before Medicare might cover it. Now, with the new TCET pathway, coverage could be granted in months. Are you prepared to immediately start the large-scale health economic studies required to make that coverage permanent? This episode tackles that critical question. **Key Questions Answered:** - What are the eligibility criteria for the new TCET pathway? - How does this program change the strategic importance of the FDA's…

People in this episode

Host: Ran Chen

Topics covered

• MedTech
• insurance coverage
• FDA regulations
• commercialization
• health economic studies

Keywords

• MedTech
• TCET pathway
• FDA
• CMS
• insurance coverage
• breakthrough designation
• health economic studies

Mentioned in this episode

Organizations: US FDA, CMS, Pure Global

Products: AI diagnostic software

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