CMS covers TAVR for asymptomatic patients and drops the evidence requirement for symptomatic ones

MedDevice Startups Staff · 2 days ago · 2 min read · Via CMS decision memo (CAG-00430R2)

CMS finalized a rewrite of the TAVR national coverage determination on September 10, closing the reconsideration it opened under CAG-00430R2. Medicare now covers transcatheter aortic valve replacement for asymptomatic severe aortic stenosis. It also covers symptomatic patients without a coverage with evidence development requirement.

Asymptomatic patients still fall under CED, so those procedures have to run inside a CMS-approved study addressing named evidence gaps. Five medical societies asked CMS to keep CED for symptomatic patients as well. CMS went the other way. Edwards Lifesciences, which requested the reconsideration, takes roughly 75 percent of its revenue from TAVR. Medtronic takes about 5.5 percent.

The structural requirements survived. A heart team with at least one cardiac surgeon and one interventional cardiologist still has to evaluate the patient, though the wording now reads aortic valve disease rather than aortic stenosis, which leaves room for indications beyond stenosis. Operators still need 20 transcatheter valve procedures a year, at least 15 of them TAVR. For a startup building a transcatheter valve, that volume floor is the part of the NCD that decides which hospitals can ever be a customer.

Questions & Answers

What did CMS decide about TAVR coverage for asymptomatic patients in September 2026?

On September 10, 2026, CMS finalized a reconsideration of the TAVR national coverage determination (CAG-00430R2) that extends Medicare coverage to asymptomatic severe aortic stenosis. Those procedures are covered under coverage with evidence development, meaning they have to be performed inside a CMS-approved study.

Does the CMS TAVR national coverage determination still require coverage with evidence development for symptomatic patients?

No. The September 10, 2026 CMS decision removes the coverage with evidence development requirement for symptomatic severe aortic stenosis. CED remains in place only for asymptomatic patients.

What operator volume does the 2026 CMS TAVR coverage determination require?

The CMS TAVR national coverage determination requires operators to perform at least 20 transcatheter cardiac valve procedures a year, at least 15 of which must be TAVR, or the equivalent volume over two years. A heart team including at least one cardiac surgeon and one interventional cardiologist must also evaluate the patient.

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