CMS Backs Edwards Lifesciences’ TTVR Treatment in New Proposal

The Centers for Medicare & Medicaid Services (CMS) have put forth a proposition to include transcatheter tricuspid valve replacement (TTVR) as a covered treatment for Medicare participants grappling with severe symptomatic tricuspid regurgitation.

This suggested coverage would be granted under a Coverage with Evidence Development (CED) framework, mandating the procedure to be a part of a CMS-endorsed clinical research endeavor to guarantee the collection of safety and efficacy data.

As per CMS, TTVR would be financially supported for patients whose conditions persist in severity despite receiving medical treatment. Eligibility for the procedure requires validation from a multidisciplinary heart team comprised of a cardiac surgeon, interventional cardiologist, heart failure cardiologist, electrophysiologist, imaging experts, and an interventional echocardiographer, all adept in treating tricuspid regurgitation.

The CED studies are asked to center on vital outcomes, including all-cause mortality and hospitalization rates, assessed over a minimum period of 24 months. Additionally, CMS highlights that studies should perform subgroup investigations based on age, gender, ethnicity, and existing health conditions.

Outside CMS-sanctioned trials, TTVR won’t be available under Medicare coverage, although it still may be considered through Medicare’s Clinical Trial Policy or covered under the FDA’s Investigational Device Exemption program.

TTVR is a procedure that replaces a defective or poorly functioning tricuspid valve in the heart with an artificial valve using a minimally invasive technique. A catheter is introduced through a blood vessel located in the groin and aimed towards the heart.

Two devices for TTVR have gained FDA approval under its breakthrough device initiative – including the Evoque system from Edwards Lifesciences and Abbott’s TriClip transcatheter edge-to-edge repair system.

In a prepared remark shared with MassDevice, Edwards emphasized, “The proposed transcatheter tricuspid valve replacement (TTVR) National Coverage Determination (NCD) lays down a route for Medicare recipients to have access to this transformative technology. We are grateful to CMS for its dedication to advancing ongoing evidence-based evaluations to ensure expedited patient access to groundbreaking treatments. We are thoroughly reviewing the policy and intend to submit feedback during the public commenting period.”