Dive Brief:
- The Centers for Medicare and Medicaid Services on Monday proposed an updated national coverage determination for transcatheter aortic valve replacement that could expand the treatment to more patients, benefiting Edwards Lifesciences.
- The proposed NCD adds Medicare coverage for beneficiaries with asymptomatic severe aortic valve stenosis who are enrolled in a CMS-approved study.
- “We are encouraged the draft coverage policy has the potential to improve timely access to lifesaving TAVR therapy for Medicare beneficiaries,” an Edwards spokesperson wrote in an email.
Dive Insight:
Medicare already covers beneficiaries who have symptomatic severe aortic stenosis, where the valve has narrowed and is reducing blood flow from the heart to the rest of the body. The CMS last updated its national coverage policy for TAVR in 2019.
Edwards last year asked the agency to reconsider the coverage policy to reflect new research that demonstrated improved outcomes when the valves are used to treat people who don’t have symptoms, such as shortness of breath and chest pain.
The Food and Drug Administration granted Edwards an expanded label last year for use of its Sapien 3 TAVR devices in asymptomatic severe aortic stenosis patients. The expanded indication reflected results of the company’s EARLY TAVR study, which showed people without symptoms had better outcomes after a TAVR procedure than if managed under clinical surveillance, also known as watchful waiting.
TAVR is Edwards’ largest business, generating 74% of its sales at the end of 2025. The company posted $4.5 billion in full-year TAVR sales last year.
Truist Securities analyst Richard Newitter said the CMS’ proposed coverage update could help the heart valve specialist gain TAVR market share from Medtronic and Boston Scientific.
Linking coverage to participation in a follow-up study could create “a slower ramp for asymptomatic volumes if the NCD is finalized as written,” but shouldn’t represent a major barrier, Newitter wrote in a note to clients.
“The revised NCD proposal reads as a clear positive to us albeit an expected one,” Newitter said.
The proposal also ends a requirement for coverage with evidence development for procedures in symptomatic patients, among other revisions.
“Ultimately in our view, the proposal loosens the site, surgeon, and volume gates rather than completely removing them but should be seen as a [positive] moving forward,” Newitter wrote.
Edwards said it looked forward to participating in the public comment process ahead of the CMS’ final decision memo. The agency will accept public comments over the next 30 days before the final decision is due in September.
