CMS finalizes sweeping TAVR changes, including Medicare coverage for asymptomatic patients
After months of consideration, the U.S. Centers for Medicare and Medicaid Services (CMS) has approved major changes to transcatheter aortic valve replacement (TAVR) coverage policies.
It is too early to tell how, exactly, these changes will impact patient care, but there is no doubt that the conversation surrounding TAVR has radically changed.
What changed?
On Thursday, Sept. 10, CMS officially finalized a new national coverage determination (NCD) for TAVR. Arguably the biggest change is that TAVR will now be covered in Medicare beneficiaries who present with asymptomatic severe aortic stenosis (AS). The treatment of asymptomatic patients has been a hot topic in recent years. Some specialists see it as a way to treat patients early and avoid long-term damage. Others disagree, preferring to save TAVR for patients who present with symptoms.
Another key update is that Medicare beneficiaries with symptomatic severe AS is now covered without any sort of coverage with evidence development (CED) requirements. The TAVR NCD has always required facilities performing TAVR to follow certain CED rules that require patient data to be collected through clinical trials or registries. This is no longer the case when it comes to performing TAVR on symptomatic patients.
Five leading U.S. medical societies—the American Association for Thoracic Surgery, American College of Cardiology, Heart Failure Society of America, Society for Cardiovascular Angiography and Interventions and Society of Thoracic Surgeons—did work together to argue that CED requirements should still be in place, but CMS still moved forward with that particular proposal.
It is worth noting, however, that CED requirements are still in place when it comes to performing TAVR on asymptomatic patients.
CMS also revised certain coverage criteria related to preprocedural patient assessments, intraoperative requirements and volume requirements. None of these revisions appear to be game-changers in terms of what is expected from clinicians in charge of the management and treatment of patients with severe AS. The idea behind these changes is to improve patient access to this established treatment.
Another key takeaway from this updated NCD is that CMS is maintaining “the concept and composition of the heart team.” Heart teams should still include at least one cardiac surgeon and one interventional cardiologist familiar with the treatment of aortic valve disease. Advanced practice clinicians, nurses and administrators should also be included in any heart team.
As CMS noted in its decision memo, the multidisciplinary heart team concept was first developed due to the rise of TAVR as a potential therapy for severe AS. Nearly everyone seems to agree that this introduction of the heart teams concept has been a major success.
One minor change to the heart team concept is the fact that participating surgeons and interventionalists should be experienced in aortic valve disease as opposed to only AS. This tweak was added due to the fact that future NCD updates may approve TAVR for "non-AS indications."
The Sapien 3 Ultra RESILIA transcatheter heart valve. Image courtesy of Edwards Lifesciences.
A bit of background about these changes
In June, CMS proposed making a number of substantial changes to current TAVR policies. Edwards Lifesciences, one of the world’s largest TAVR vendors, requested the update. The company pointed to EARLY TAVR data published in The New England Journal of Medicine, for example, as evidence that treatment with its balloon-expandable transcatheter heart valves was associated with key benefits for patients presenting with asymptomatic severe AS.[1]
Another key moment in the development of this story was when the U.S. Food and Drug Administration (FDA) approved the Sapien 3 TAVR platform from Edwards Lifesciences for treating asymptomatic severe AS in May 2025. The FDA’s decision covered the Sapien 3, Sapien 3 Ultra and Sapien 3 Ultra Resilia transcatheter heart valves.
Once that approval was announced, many experts assumed it would only be a matter of time before CMS considered updating the NCD for TAVR.
Hundreds of public comments were submitted to CMS about these changes. The agency pointed to many of those comments in its decision memo.
Leading TAVR vendors comment on changes
Edwards Lifesciences, the company that first requested an updated TAVR NCD, issued a quick statement celebrating the new policies.
“Edwards is pleased that this updated policy represents an important step toward improving and expanding patient access to TAVR while reinforcing the value of a multidisciplinary heart team," the company said. "AS is a serious, progressive disease, and delays in evaluation, diagnosis and treatment increase the risk of irreversible heart damage and hospitalization, leading to poorer outcomes and higher healthcare costs, as well as an increased risk of death. The modernized policy recognizes the importance of timely care by supporting a more streamlined patient care journey and giving heart teams greater flexibility to apply their expertise to both patient evaluation and treatment based on each patient’s clinical needs. Throughout this NCD process, our priority has remained the same: ensuring appropriate access to TAVR, a mature, reproducible procedure backed by an unparalleled body of evidence and support of the heart team approach. We appreciate the leadership of CMS and engagement of all stakeholders who contributed evidence, perspectives and expertise to inform this important review of Medicare coverage policy.”
Medtronic, another leading TAVR vendor, issued a statement of its own.
"We are also pleased that the final policy continues to recognize the importance of the multidisciplinary heart team," the company wrote. "Collaboration is foundational to individualized patient evaluation, treatment planning, procedural decision-making, and long-term care."
The company also highlighted its ongoing commitment to expanding access to care for heart patients.
"We look forward to working with CMS, physicians, hospitals, and the broader cardiovascular community to support implementation of the updated policy and help ensure patients benefit from safe, effective and high-quality care."
This is a developing story. Stay tuned to Cardiovascular Business for reactions from throughout the industry.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.