Dive Brief:
- The Centers for Medicare and Medicaid Services on Thursday published a finalized national coverage determination for transcatheter aortic valve replacement that is expected to expand the treatment to more patients with severe aortic stenosis, a narrowing of the heart valve that blocks blood flow to the body. The updated policy provides Medicare coverage for patients who are asymptomatic, among other changes.
- Edwards Lifesciences, which had asked the CMS to reconsider its 2019 coverage policy, said the new criteria will improve patient access and create opportunities for TAVR programs. Rival heart valve maker Medtronic also welcomed the decision and noted it encourages continued evidence generation.
- Wall Street analysts weighing in on the policy called it a clear positive for Edwards, which derives most of its revenue from TAVR.
Dive Insight:
The CMS decision comes after the Food and Drug Administration approved an expanded indication for Edwards’ Sapien 3 TAVR platform in April 2025 for people who have severe aortic stenosis without symptoms, such as shortness of breath and chest pain, in addition to symptomatic patients.
The expanded indication was based on the company’s EARLY TAVR study showing asymptomatic patients fared better after a TAVR procedure than if managed under clinical surveillance, also known as watchful waiting.
The CMS’ finalized NCD kept most key points from the agency’s June proposal, analysts said. The policy ends a requirement for coverage with evidence development for TAVR procedures in symptomatic severe aortic stenosis patients but requires evidence development in the asymptomatic group. Some U.S. medical societies had advocated for maintaining evidence requirements for all patients after the new policy was proposed.
Though medical groups generally supported covering TAVR in asymptomatic patients, some doctors argued that more data was needed.
TAVR represents about 75% of Edwards’ revenues and 5.5% of Medtronic’s revenues, according to Stifel analysts, who valued the global market for the procedure at more than $7 billion.
“With similar language as the recent proposal, to us, this final determination is clearly constructive for the overall TAVR market and for Edwards in particular given the company’s TAVR market leadership,” the analysts wrote.
BTIG analysts said the updated policy will benefit the TAVR field as a whole, but especially Edwards. “We see these as positive changes that can eventually increase TAVR procedure volumes,” they said.
Edwards, in its statement on the NCD, said that as the new CMS policy will take time to implement, “the company has confidence in its previously communicated financial guidance for 2026” and will provide longer-term guidance at an investor conference in December.
The CMS also said it would review TAVR coverage for patients with aortic regurgitation, a condition in which the valve does not close properly and allows blood to leak backward. The FDA approved the first TAVR system for aortic regurgitation, JenaValve’s Trilogy system, in March. The CMS expects to propose a coverage decision by March 2027.
