Proposed TAVR NCD Decision Memo Posted; More Positive Than We Expected

Research evidence excerpt

Proposed TAVR NCD Decision Memo Posted; More Positive Than We Expected

I N D U S T R Y N O T E

J u n e 1 5 , 2 0 2 6

Medical Technology and Devices

CONCLUSION Adam C. Maeder

Today, CMS published its proposed decision memo for the TAVR NCD. The most important Sr. Research Analyst, Piper Sandler & Co.

proposed update is the addition of asymptomatic AS coverage as this should streamline 212 284-9392, adam.maeder@psc.com

reimbursement for this patient segment and provide a tailwind to volumes beginning in Kyle Winborne

Q4:2026. The changes to the operator requirements and hospital criteria were generally Research Analyst, Piper Sandler & Co.

212 466-8060, kyle.winborne@psc.compositive and we believe should allow for more TAVR centers to be established in the

coming years and an incremental volume uplift. We were also pleased to see the “joint Andrea Irawan

Research Analyst, Piper Sandler & Co.

operator” requirement removed in the proposed document. Finally, the elimination of the 212 284-9587, andrea.irawan@psc.com

CED requirements for symptomatic severe AS was a welcomed surprise and should help

remove some red tape. Overall, we see the contents of the draft document as positive and Related Companies: Share Price:

better-than-expected. To be clear, today’s document is just a proposal. Up next is another ABT 88.67

public comment period (ends 7/15/26) before the final NCD is furnished (expected 9/13/26). EW 86.28

INDUSTRY RISKS

• What Happened? Today (6/15), CMS published its proposed decision memo for the

TAVR (transcatheter aortic valve replacement) NCD (national coverage determination) Competition, Pricing Pressure, Reimbursement,

Clinical Data, Commercial Execution, Litigation following an initial comment period earlier this year. The draft TAVR NCD document