CMS Greenlights Reimbursement for Transcatheter Tricuspid Valve Replacement (TTVR)

 A major milestone just dropped in the world of interventional cardiology! The Centers for Medicare & Medicaid Services (CMS) has officially agreed to reimburse Transcatheter Tricuspid Valve Replacement (TTVR) — but there’s a catch. Let’s break it down piece by piece 🧩.

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📜 What Did CMS Approve?

As of March 19, 2025, CMS issued a final national coverage determination (NCD) for TTVR. The therapy will now be reimbursed when it’s used for an FDA-approved indication, specifically for patients with symptomatic tricuspid regurgitation (TR) who haven’t responded to optimal medical therapy.

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👨‍⚕️👩‍⚕️ The Heart Team Matters

CMS is not playing around when it comes to patient selection. Reimbursement will only occur when a multidisciplinary heart team is involved. At a minimum, the team must include:

Specialist Role	Required Expertise
Cardiac Surgeon	Structural heart interventions
Interventional Cardiologist	Valve replacement procedures
Heart Failure Cardiologist	Heart failure management
Electrophysiologist	Rhythm disorder expertise
Imaging Specialists	Multimodality cardiac imaging
Interventional Echocardiographer	Intra-procedural echo guidance

✅ All team members must have prior experience with TR management.

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🧪 Evidence First: Coverage With Evidence Development (CED)

CMS isn't offering a blank check 💵. TTVR is only covered under the Coverage with Evidence Development (CED) pathway. That means:

• Must be done in a CMS-approved study 🧪
• Primary outcomes: All-cause mortality and/or hospitalizations 🏥
• Minimum 24-month follow-up ⏳
• Must include an active comparator group 🔄
• Requires a care management plan involving every team member 💼
• Should allow for subgroup analysis (think gender, comorbidities, etc.) 📊

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🧬 Behind the Decision: Trials That Turned the Tide

This decision didn’t happen in a vacuum 🌪️. It was backed by data from two pivotal studies of the Evoque system, the first FDA-cleared TTVR device (approved in Feb 2024):

🔬 Key Trials

Trial Name	Design	Key Outcomes at 1 Year
TRISCEND	Single-arm	Symptom improvement, reduced TR
TRISCEND II	Randomized	🔻 TR “nearly eliminated” ✅ Better symptoms & quality of life 💀 Fewer deaths & HF hospitalizations (numerically)

These studies demonstrated that TTVR + optimal medical therapy significantly outperformed medical therapy alone, transforming the clinical landscape for severe TR patients 🙌.

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🗣️ Public Input & Process

The journey began in June 2024 when the manufacturer requested CMS coverage. Since then, there were:

• 2 public comment periods 🗨️
• A proposed decision in December 2024 📅
• Now: A final determination in March 2025 ✅

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🧠 Take-Home Points

💡 Here's what you need to remember:

• TTVR is now reimbursable under CMS — but only within approved clinical studies
• Patients must have symptomatic TR and failed medical therapy
• A full multidisciplinary heart team is mandatory
• The Evoque system led the charge with impressive trial outcomes
• Long-term data collection is key — CED model requires 2-year follow-up
• This sets a precedent for evidence-based innovation reimbursement 💼💉

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🔮 The Future?

This move by CMS could pave the way for wider adoption of structural tricuspid therapies, potentially opening the door to more permanent coverage in the future—once we have long-term outcomes 🔍.

For now, we celebrate a victory for patients with severe TR, and a signal that technology and policy can dance together, with rhythm and precision 🕺🎶.