The proposed decision would allow coverage under a Coverage with Evidence Development (CED) framework, requiring the procedure to be part of a CMS-approved clinical study to ensure safety and efficacy data collection.
According to CMS, TTVR would be covered for patients whose condition remains severe despite medical therapy. A multidisciplinary heart team would have to confirm the appropriateness of the procedure. This team must include a cardiac surgeon, interventional cardiologist, heart failure cardiologist, electrophysiologist, imaging specialists, and an interventional echocardiographer, all of whom must have experience in treating tricuspid regurgitation.
The proposal requires CED studies to focus on critical outcomes such as all-cause mortality and hospitalizations over at least 24 months. The agency also said studies must conduct subgroup analyses by age, sex, race, and pre-existing conditions.
Outside of CMS-approved studies, TTVR would not be covered for Medicare beneficiaries. However, the procedure could still qualify for coverage under Medicare’s Clinical Trial Policy or the FDA’s Investigational Device Exemption program.
TTVR is a minimally invasive medical procedure that involves replacing a damaged or malfunctioning tricuspid valve in the heart with an artificial valve. A catheter is inserted through a blood vessel in the groin and guided to the heart.
The FDA has approved Edwards’ Evoque TTVR system through its breakthrough device program.
“Edwards believes the proposed transcatheter tricuspid valve replacement (TTVR) National Coverage Determination (NCD) provides a pathway for beneficiary access to this innovative technology. We appreciate CMS’ commitment to supporting ongoing evidence generation to enable timely patient access to new therapies. We are continuing to analyze the policy and will be submitting a public comment for consideration,” Edwards said in a statement shared with MassDevice.
Abbot has requested similar coverage for its TriClip transcatheter edge-to-edge repair (TEER) system, which the FDA also approved for tricuspid regurgitation through its breakthrough devices program. CMS anticipates a proposed decision memo in April 2025 and completion of its coverage analysis in July.
Medical Design & Outsourcing: How Abbott designed TriClip to repair the ‘forgotten’ tricuspid heart valve
— Managing Editor Jim Hammerand contributed to this report.
