CMS proposes major TAVR changes, including Medicare coverage for asymptomatic patients
After months of consideration, the U.S. Centers for Medicare and Medicaid Services (CMS) has proposed substantial changes to current transcatheter aortic valve replacement (TAVR) coverage policies. One of those changes, if finalized, would require Medicare to cover TAVR for the treatment of severe aortic stenosis (AS) in asymptomatic patients.
A closer look at the CMS proposal
CMS officially proposed three significant changes to its current national coverage determination (NCD) for TAVR.
1. TAVR will now be covered in asymptomatic patients
Medicare currently only covers TAVR in patients who present with symptoms. This proposal, however, would expand coverage to include patients who present with asymptomatic severe AS.
Many cardiologists and cardiac surgeons have come out publicly against the treatment of asymptomatic patients with TAVR. It creates unnecessary risks for patients who may not even require treatment, they argue. But there are also many clinicians who support the early treatment of these patients, noting that a large number of patients with asymptomatic severe AS eventually go on to develop symptoms and require care.
2. CED requirements are no longer required when treating symptomatic patients
The TAVR NCD has always required facilities performing TAVR to follow certain coverage with evidence development (CED) rules that require patient data to be collected through clinical trials or registries. Edwards argued that TAVR has matured enough over the years that these restrictions are no longer necessary—a belief many public commenters appeared to share.
However, five leading U.S. medical societies—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)—have all argued that CED requirements remain critical.
“The societies strongly believe that continuation of the CED paradigm is essential to address existing and emerging clinical questions,” the groups wrote in a January statement. “Submission of data on all TAVR procedures to a national registry should remain a requirement.”
3. Certain coverage criteria will be revised going forward in an effort expand access to more patients
According to its proposal, CMS wants to “streamline and update requirements related to pre-procedural patient assessments, intraoperative requirements, and operator and hospital procedural volume requirements.”
For example, the previous TAVR NCD required facilities performing TAVR to have a certain amount of established experience with open-heart valve procedures. Those requirements would be removed going forward.
Cardiac surgeon consultations are still required
Another key takeaway from this proposal is the fact that CMS is no longer considering a change that would have meant surgeons were no longer required to participate in multidisciplinary heart team discussions prior to TAVR.
The original idea was that TAVR is established enough now that cardiac surgeon feedback should not be necessary. Based on feedback from the cardiology and cardiac surgery communities, however, CMS has decided to “maintain the concept and composition of the heart team.”
What prompted these changes?
CMS agreed to consider these changes at the request of Edwards Lifesciences, one of the world’s largest TAVR vendors. Edwards pointed to EARLY TAVR data published in The New England Journal of Medicine as evidence that treatment with its balloon-expandable transcatheter heart valves was associated with key benefits for patients presenting with asymptomatic severe AS.[1]
On a related note, the U.S. Food and Drug Administration (FDA) approved the Sapien 3 TAVR platform from Edwards for treating asymptomatic severe AS in May. The FDA’s decision covered the Sapien 3, Sapien 3 Ultra and Sapien 3 Ultra Resilia transcatheter heart valves, which remain the only devices currently approved for the treatment of asymptomatic TAVR.
These proposals are certainly positive news for Edwards. It could also be argued that the changes would also be good for Medtronic and other TAVR vendors.
Edwards Lifesciences, Medtronic shares statements
Edwards, as one may expect, had a positive reaction to the CMS proposal.
"Edwards thanks CMS for continuing to prioritize and advance the reconsideration of the TAVR NCD," a company spokesperson told Cardiovascular Business. "We are encouraged the draft coverage policy has the potential to improve timely access to lifesaving TAVR therapy for Medicare beneficiaries, and look forward to participating in the public comment period over the next 30 days, ahead of the issuance of the final decision memo in September."
Medtronic, the medtech giant behind the Evolut TAVR platform, shared its own perspective on the proposal. In a statement sent to Cardiovascular Business, the company applauded CMS while highlighting the importance of tracking TAVR data over time.
"Medtronic thanks CMS for their clear commitment to help ensure that coverage policies continue to support patient access to safe, effective and evidence-based care. Over the past decade, consistent participation in national registries and CED have played a critical role in building a robust evidence base for TAVR, advancing patient outcomes and assuring high-quality care for patients.
As CMS considers potential updates, we believe it is important to build on this foundation by maintaining mechanisms that support ongoing quality monitoring and continuous evidence generation, including established registry-based reporting. These frameworks are essential to ensuring patient safety, enabling transparent benchmarking, and supporting responsible expansion of coverage as new indications emerge and new TAVR programs are activated."
Medtronic went on to share its perspective on other aspects of the new proposal.
"We applaud CMS for maintaining some key safeguards— including operator procedural volume thresholds, CED as appropriate, and defined multidisciplinary heart team requirements—as these impact the consistency of care delivery and the ability to monitor outcomes across sites. These elements have been foundational to maintaining strong standards of TAVR care. We appreciate CMS’ consideration of how changes to this framework may have implications for patient safety and outcomes, particularly as access expands to new sites and patient populations, and urge CMS to continue to consider how these important requirements can assure high-quality care.
We firmly believe that the multidisciplinary heart team model remains foundational to the delivery of optimal structural heart care, supporting appropriate patient selection, procedural planning and post-procedural management. At the core of this approach is coordinated participation from qualified procedural specialists with appropriate privileges at the TAVR facility. This will ensure that aortic stenosis patients continue to understand the full range of treatments available to them and have a full suite of services on-site in the event of emergency management.
As innovation advances and indications expand, we support a thoughtful, evidence-based approach to expanding coverage for new patient populations, including the continued use of tools such as enhanced quality oversight through established mechanisms like registry use and also CED where appropriate to ensure long-term outcomes are well understood. We urge CMS to ensure that it does not inadvertently reduce previously approved coverage for TAVR as it considers how best to continue to enhance access to new indications.
High-quality care delivered through a collaborative, multidisciplinary heart team will remain essential to the future of TAVR. We look forward to engaging in the public comment process and working with stakeholders to help ensure that any updates to the NCD reflect the latest science, support clinical judgment, and preserve appropriate access for patients who may benefit from TAVR.”
CMS now accepting public comments
CMS is accepting public comments on this proposal until July 15.
Click here for additional context or to leave a comment.
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.