CMS finalizes TAVR coverage: study requirement dropped for symptomatic AS, added for asymptomatic

Two things changed for TAVR claims on September 10, 2026. Symptomatic severe aortic stenosis no longer needs a coverage with evidence development (CED) study, and asymptomatic severe aortic stenosis is now coverable, but only when the procedure is furnished inside a CMS-approved CED study. CMS finalized both in its transcatheter aortic valve replacement (TAVR) decision memo, CAG-00430R2.

What CMS finalized

CMS made three changes at once. It dropped the CED requirement for symptomatic severe aortic stenosis. It extended coverage to asymptomatic severe AS under CED. And it revised the criteria for pre-procedure patient assessment, intraoperative care, and operator and hospital procedural volume.

The procedure is covered only when it uses a complete aortic valve and implantation system that holds FDA premarket approval (PMA) for that system's approved indication.

Symptomatic severe AS: the study requirement is gone

For symptomatic severe aortic stenosis, coverage now sits under Section 1862(a)(1)(A) of the Social Security Act, with no CED condition attached. That drops the study strings the prior NCD tied to these cases.

Practical read: the coverage basis for a symptomatic TAVR claim changed, but don't assume the billing mechanics did. CMS will revise the TAVR national coverage determination through the manual language in Appendix A of the memo, and the billing instructions follow through that implementation. Wait for it before you touch a modifier or a condition code.

Asymptomatic severe AS: covered, but only inside a CED study

This is the expansion. TAVR for asymptomatic severe aortic stenosis is now covered, but under CED and Section 1862(a)(1)(E). In plain terms, the claim only holds if the procedure is furnished in the context of a CMS-approved CED study. Coverage for asymptomatic disease is conditional on that, not automatic.

CMS also opened a separate national coverage analysis the same day for TAVR in aortic regurgitation (CAG-00430R3). That's a different question and isn't decided here.

New operator volume and heart-team rules

CMS finalized operator-level volume requirements for TAVR. A TAVR operator must be an interventional cardiologist or cardiac surgeon on the heart team and must perform:

• at least 20 total transcatheter cardiac valve procedures a year, at least 15 of them TAVR; or
• at least 40 such procedures over two years, at least 30 of them TAVR.

The heart team must include at least one cardiac surgeon and one interventional cardiologist experienced in aortic valve disease, each with clinical privileges at the hospital where the TAVR is furnished. The pre-procedure evaluation has to be in person: CMS states it can't be satisfied through a virtual encounter. A telehealth-only evaluation is a coverage gap.

Old vs new: TAVR coverage at a glance

What this changes on the claim

For a facility or cardiology coder, the split is the thing to hold onto. Symptomatic severe AS drops a condition. Asymptomatic severe AS gains one. The diagnosis on the record decides which coverage path the claim rides, so the assessment that establishes symptoms, or their absence, has to be legible in the note. Confirm the aortic stenosis diagnosis maps cleanly in the encoder, and pull the supporting documentation together with the evidence builder so the heart-team evaluation and operative note back the coverage path you billed. For the descriptors themselves, the code book carries the current aortic stenosis entries (I35.0, or I35.2 when insufficiency coexists). It's the second CMS coverage decision to cross the desk in recent months, alongside the ColoSense NCD, and both turn on the same discipline: match the claim to what the record actually shows.