EW: TAVR 4 More - Proposed NCD Adjusted Positively on All Fronts of the Debate

研报英文原文证据摘录

EW: TAVR 4 More - Proposed NCD Adjusted Positively on All Fronts of the Debate

June 15, 2026

Topic-by-topic blackline

1. Covered population & coverage authority

OLD (NCD 20.32, v2 – 2019):

TAVR is covered under Coverage with Evidence Development (CED) for the treatment of symptomatic aortic valve

stenosis when furnished according to a Food and Drug Administration (FDA)-approved indicationMedicare

beneficiaries with: (1) symptomatic severe AS under §1862(a)(1)(A) of the Act; and (2) asymptomatic severe AS

under CED, §1862(a)(1)(E) of the Act.

NEW (Proposed CAG-00430R2 – 2026):

CMS proposes to (1) cover TAVR for symptomatic severe AS without the CED requirement; (2) expand coverage to

asymptomatic severe AS with CED; and (3) revise pre-procedural assessment, intraoperative, and operator/hospital

volume criteria.

2. Device requirement (unchanged in substance)

The procedure is furnished with a complete aortic valve and implantation system that has received FDA premarket

approval (PMA) for that system’s FDA-approved indication.

3. Heart team composition

The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multi-disciplinary

team of medical professionals with a specialized focus in cardiac care. The heart team includes a cardiac surgeon

and an interventional cardiologist experienced in the care and treatment of aortic stenosismust include at least one

cardiac surgeon and one interventional cardiologist experienced in the care and treatment of AS and each with

clinical privileges at the hospital where the TAVR will be furnished; plus providers from other physician groups,

advanced practitioners, nurses, research personnel and administrators.and may include other physicians, advanced