Medical societies, medtech companies and clinicians weigh in as CMS considers sweeping TAVR changes
The U.S. Centers for Medicare and Medicaid Services (CMS) is considering making substantial changes to how Medicare covers transcatheter aortic valve replacement (TAVR) procedures in the United States. Some stakeholders are excited about the idea, embracing the possibility of expanded indications and fewer restrictions. Others are less enthusiastic, sharing concerns that patient care could suffer as a result.
What could change if CMS updates its Medicare policies for TAVR?
CMS first finalized its national coverage determination (NCD) for TAVR back in 2012 and then revisited that policy in 2019. Now, after receiving a formal request from Edwards Lifesciences, CMS is once again reconsidering the NCD to determine if any major updates are needed.
It is not exactly clear how far CMS is thinking about going with its changes to the TAVR NCD, but multiple major updates appear to be on the table.
- The end of CED requirements
TAVR techniques and technologies have evolved significantly in recent years, and Edwards said in its request that coverage policies need to evolve as well. For example, the TAVR NCD has always included coverage with evidence development (CED) rules that require patient data to be gathered through clinical trials or registries. CED requirements are meant to be temporary, Edwards argued, and the TAVR has matured enough as a therapy that these restrictions are no longer necessary.
“TAVR is among the most rigorously studied medical device technologies subject to CED,” according to the Edwards. “Through this NCD reconsideration, CMS has an opportunity to demonstrate responsiveness to the extensive evidence collected to date by establishing a successful end to CED for TAVR.”
- Approved TAVR procedures for asymptomatic patients
Edwards also asked CMS to consider fully covering TAVR in asymptomatic patients. TAVR was initially approved for patients with symptomatic severe aortic stenosis (AS)—no symptoms meant no procedure—but there has been a push in recent years to approve treatment in asymptomatic patients who present with signs of severe AS on medical imaging results.
Edwards has been leading that particular charge, pointing to clinical evidence from the EARLY TAVR clinical trial—which it sponsored—as proof that treating these patients right away provides significant value.
In May 2025, when the U.S. Food and Drug Administration (FDA) officially approved Edwards’ balloon-expandable Sapien 3 TAVR platform for the treatment of asymptomatic AS, it became clear the company would be pushing CMS to rethink its current coverage policies.
Even experts who do not necessarily agree with treating asymptomatic patients with TAVR still largely believe CMS and the FDA should to be on the same page. When the FDA is approving medical devices for specific therapies, but CMS does not cover the therapy in question, it creates the potential for considerable confusion.
- A changing approach to multidisciplinary heart teams
For Medicare to cover any TAVR procedure, there are rules in place that required at least one cardiac surgeon to be consulted. Now that the procedure has evolved, however, there is a belief among some TAVR advocates that surgeon evaluations are no longer necessary and an interventional cardiologist can handle any treatment decisions.
The Edwards request pointed to positive outcomes during the COVID-19 pandemic, a time when collaborations were harder in healthcare for logistical reasons, as evidence that surgeons only need to be consulted on more complex cases. CMS now appears to be considering changes to these requirements.
Potential changes receive mixed feedback
CMS announced its intention to reconsider the current NCD for TAVR in December, urging stakeholders to share public comments by Jan. 14. Medical societies, medtech vendors, cardiologists, surgeons and many other stakeholders all stepped forward to share their perspective.
Leading medical societies share unified statement
Five leading U.S. medical societies responsible for the treatment of patients with severe AS collaborated on a unified response to the CMS request. The American Association for Thoracic Surgery (AATS), American College of Cardiology (ACC), Heart Failure Society of America (HFSA), Society for Cardiovascular Angiography and Interventions (SCAI) and Society of Thoracic Surgeons (STS) all signed on to the statement
One key takeaway from the statement is that the societies think it is still too early to end the CED requirements. Registry data and clinical trials have provided substantial evidence that directly led to TAVR being offered to additional patient populations, the groups wrote. They emphasized that real-world evidence and clinical data remain necessary as the procedure continues to evolve.
“The societies strongly believe that continuation of the CED paradigm is essential to address existing and emerging clinical questions,” they wrote. “Submission of data on all TAVR procedures to a national registry should remain a requirement.”
The five societies also appear to accept that TAVR may be covered for the treatment of asymptomatic patients in the near future. This remains a relatively controversial topic among cardiologists and cardiac surgeons, with some embracing the use of asymptomatic TAVR and others fearful that it could put patents at risk, but it does appear to be inevitable in the wake of the FDA’s approval of the Edwards platform.
Instead of arguing against the treatment of asymptomatic patients, the groups highlighted the importance of maintaining high-quality patient care. Treating AS requires a “comprehensive, team-based approach,” they wrote, and multi-disciplinary teams should remain at the center of any treatment decisions.
Click here for the full public comment from AATS, ACC, HFSA, SCAI and STS.
Medtronic shares its own perspective on potential TAVR coverage changes
Medtronic and Edwards are largely seen as the two leading TAVR vendors in the United States. Edwards was the company that initially got this process started, but what does Medtronic think about these potential changes? The company shared a public comment that summarized where it stands.
Overall, Medtronic said it remains in support of CED as “a mechanism to support coverage and evidence generation.” Data can be captured in a “minimally burdensome manner,” the company wrote, and doing so is beneficial for both providers and the patients they serve.
In addition, Medtronic shared its concerns about Medicare coverage being approved for symptomatic patients. While the initial approval of TAVR in symptomatic patients was based on a significant amount of data, the company wrote, there is still only limited data on the treatment of patients who present without symptoms.
“While promising, the evidence of efficacy of TAVR in asymptomatic patients is focused on one trial plus another which is noted to have inadequate statistical power, with two more randomized controlled trials currently enrolling,” according to the Medtronic comment.
Medtronic also said it still wants cardiac surgeons to be involved in treatment decisions, highlighting the importance of their experience and expertise when it comes to surgical aortic valve replacement.
Edwards provides an additional comment
Edwards did issue a public comment of its own. The company reiterated that it believes 1.) the NCD’s CED requirements have been satisfied, and 2.) TAVR should be covered for the treatment of asymptomatic severe AS.
However, Edwards also said it believes cardiac surgeons should remain a central part of any multidisciplinary heart team. Removing surgeons from TAVR discussions is one potential change the company does not appear to support.
The full Edwards statement is available here.
Other public comments show a variety of responses
CMS received a total of 170 public comments about the TAVR NCD. Many of those comments cheered the possibility that there could soon be fewer restrictions on patient car, but others included genuine concerns about how things might unfold if too many changes are put into place.
For now, CMS certainly has a lot of feedback to consider. A proposed decision memo is expected in June 2026.
Click here for more details from CMS about the TAVR NCD.
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.