CMS proposed an update to its National Coverage Determination (NCD), having initiated a review in December 2025 after accepting a request from TAVR leader Edwards Lifesciences for an NCD update.
The proposal, set to be completed on Sept. 13, 2026, extends coverage to asymptomatic TAVR procedures. It also removes the coverage with evidence (CED) requirement for symptomatic TAVR procedures, removes hospital volume requirements and eliminates specific operator requirements for new TAVR programs.
BTIG analysts Marie Thibault, Alexandra Pang and Sam Eiber call the proposal a “clear positive” for Edwards, in particular. They say it benefits the TAVR field as a whole, including Medtronic and Abbott, among others. That could include Boston Scientific, which recently signaled its intent to re-enter the TAVR market through an investment in MiRus.
The analysts note that CMS’ addition of a CED requirement for asymptomatic TAVR, falling in line with expectations. TAVR programs need to maintain a certain volume threshold, which the analysts label achievable and not burdensome.
“These are all positive changes that we expect will remove barriers and can eventually lead to higher TAVR procedure volumes,” the analysts said. “We think this proposal is a good thing for TAVR volumes and if finalized, will serve as a tailwind for TAVR market leader [Edwards].”
