Stifel sees CMS TAVR coverage update as positive for Edwards

Investing.com -- CMS published a finalized, updated TAVR national coverage determination Friday, with language that closely mirrors the June proposal document. Stifel analysts said the final determination is constructive for the overall TAVR market and for Edwards Lifesciences given the company's market leadership position.

TAVR is a $7 billion-plus global market and represents approximately 75% of Edwards revenues and around 5.5% of Medtronic revenues, according to the firm.

CMS concurrently announced it is initiating a national coverage analysis for TAVR devices that treat aortic regurgitation, including devices like Edwards' clinical-stage J-Valve and the privately held, FDA-approved JenaValve. The expected completion date for this analysis is June 8, 2027.

The final decision re-affirmed CMS proposal to support TAVR in asymptomatic aortic stenosis patients. Stifel called this expected and positive for TAVR, noting that asymptomatic aortic stenosis support was one of the key factors which drove the national coverage determination re-opening.

CMS maintained the heart team and the role it plays in aortic stenosis patient evaluation. The final document confirms and explicitly states the cardiac surgeon's continued role, specifically saying that the heart team process includes input from both cardiac surgery and interventional cardiology.

The finalized decision allows asynchronously using medical records to identify patient suitability for TAVR or other treatments, though patients still must have an in-person evaluation and the cardiac surgeon still plays a role. Stifel said this finalized update appears to be a net positive for TAVR.

CMS finalized that only one TAVR operator needs to be present in the operating room during a procedure. CMS also held that TAVR must be performed at a site with cardiac surgery back-up. Stifel said dropping the surgeon in the room requirement is a key TAVR scheduling efficiency benefit.

TAVR volume requirement standards from the proposal document were maintained in the final decision. The document states that operators must perform 20 or more total transcatheter cardiac valve procedures, 15 of which must be TAVR, every year, or perform 40 or more such procedures, 30 of which must be TAVR, every two years.

Medicare eliminated the coverage with evidence development requirement for all severe aortic stenosis patients except in the newly supported asymptomatic severe aortic stenosis group.

Stifel said the update supports Edwards' overall 10%-plus long-range plan revenue growth outlook, along with the company's pipeline innovations and positive competitive dynamics.

You May Also Be Interested In

• Edwards Lifesciences responds to CMS TAVR coverage decision
• Jefferies conference highlights mining sector optimism on copper
• Wells Fargo analyst sees deepening troubles for Western brands in China