CMS Approves National Coverage for Transcatheter Tricuspid Valve Replacement (TTVR)
CMS Approves National Coverage for Transcatheter Tricuspid Valve Replacement (TTVR)
Highlighted on: March 21, 2025.
Full article: CMS Announcement.
1. What is CMS?
• The Centers for Medicare & Medicaid Services (CMS) is a U.S. federal agency that administers the nation’s major healthcare programs and determines national coverage policies for medical procedures and devices.
2. Key Update:
• CMS has approved Medicare coverage for transcatheter tricuspid valve replacement (TTVR) on a national level.
3. Clinical Indication:
• The procedure is indicated for patients with symptomatic tricuspid regurgitation (TR) who have not responded to optimal medical therapy.
• The goal is to reduce symptoms and improve outcomes without the need for open-heart surgery.
4. Device Background:
• The Evoque TTVR system by Edwards Lifesciences is the first FDA-approved TTVR device for this indication.
• Approval and coverage were supported by favorable results from the TRISCEND II trial.
5. Ongoing Developments:
• CMS is also evaluating coverage for transcatheter tricuspid valve repair, with a final decision expected soon.https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=314