Physicians support Medicare coverage for TAVR in patients with aortic regurgitation
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The U.S. Centers for Medicare and Medicaid Services (CMS) is considering a policy change that would cover transcatheter aortic valve replacement (TAVR) for the treatment of native aortic regurgitation (AR). As it always does with these updates, the agency began by calling for public comments from clinicians and other stakeholders about how the change would impact patient care.
Three U.S. medical societies focused on cardiovascular care, the American College of Cardiology (ACC), Society for Cardiovascular Angiography and Interventions (SCAI) and Society of Thoracic Surgeons (STS), have now shared their official response to CMS. These three groups represent cardiologists, interventional cardiologists and cardiothoracic surgeons, respectively, and their feedback was written based on the perspective of all three specialties.
Background on TAVR and aortic regurgitation
TAVR is traditionally reserved for treating severe aortic stenosis (AS). Aortic valve surgery has been the go-to treatment option for severe AR for many years now. However, the risks associated with these surgeries—and the long recovery times—lead some clinicians to perform TAVR instead with valves specifically built to treat AS instead of AR. This off-label strategy is obviously less than ideal, though it does suggest that clinicians may embrace a change.
It was with all of this in mind that CMS announced it may cover TAVR to treat native AR. According to the agency, it made its decision internally after reviewing public comments and not at the request of an outside vendor.
It is also worth noting that JenaValve recently received U.S. Food and Drug Administration (FDA) approval for its Trilogy Transcatheter Heart Valve System to be used for TAVR in patients with symptomatic, severe AR. This was the first time the agency ever approved any TAVR technology for AR, and it seems to make it much more likely that CMS will ultimately decide to go through with this change. Additional TAVR systems are expected to be approved for this same indication in the future.
Leading medical societies share comments and recommendations
In a joint letter to CMS, the ACC, SCAI and STS emphasized that they “strongly support” Medicare coverage for TAVR to treat symptomatic, severe AR. The patient’s AR should be confirmed by echocardiography or cardiac MRI scans, they added, and only FDA-approved TAVR devices should be considered.
The groups also wrote that patients with AR have “historically faced limited treatment options” and the recent FDA approval of the Trilogy Transcatheter Heart Valve System “has the potential to expand access to life-improving and life-saving care.”
However, they noted that this update should include a coverage with evidence development (CED) framework that requires facilities to report their patient data to a registry so it can be reviewed and evaluated at a later date. CMS recently killed the CED requirements for symptomatic severe AS, but the requirements are still in place whenever asymptomatic patients undergo TAVR.
The three groups also called for CMS to establish a “clear and predictable coverage pathway that leverages existing TAVR program infrastructure while recognizing the unique clinical considerations associated with AR.”
“Doing so would help minimize unnecessary administrative burden, promote operational clarity for providers, and ensure timely beneficiary access to appropriate transcatheter treatment options as evidence and clinical experience continue to grow,” they wrote.
Another key takeaway from the joint letter was the relatively small amount of available data on patients undergoing TAVR to treat native AR. Nearly 1 million patients have undergone TAVR for AS, the groups wrote, but there is only real-world data on approximately 1,500 patients who underwent TAVR for native AR. This represents just one of the many reasons the three groups pointed to the importance of multidisciplinary heart team meetings when making decisions related to these procedures. The heart team has been a critical part of TAVR’s success and growth over the last two decades; it should be an essential step whenever patients for native AR are being considered for TAVR, the groups explained.
“The societies believe that an in-person evaluation by both an interventional cardiologist and a cardiac surgeon from the heart team must remain an essential component of patient assessment and treatment planning,” the groups wrote, including bold and italics to drive home their message. “This approach provides an important safeguard for appropriate patient selection and consideration of all available treatment options without relying on potentially burdensome numerical eligibility criteria that may not fully capture the complexity of individual patients. The complementary expertise of these specialists is critical to evaluating the full range of therapeutic options, including transcatheter intervention, surgical valve replacement, reconstructive options for the aortic valve, and management of associated aortic pathology.”
Multimodality imaging assessments are also essential parts of the care process, according to the joint letter. Getting imaging specialists involved in these decisions from the beginning is critical to ensure clinicians understand the specific details of each case.
The joint letter showed that the ACC, SCAI and STS also want a continued focus on quality improvement. While CMS is making it a priority to improve patient access to TAVR, the groups want to make sure this never results in substandard care.
“The success of TAVR in the U.S. has been driven not only by expanded access, but also by a longstanding commitment to evidence generation, quality oversight, and accountability,” they wrote. “Clarifying how programs may demonstrate adherence to quality improvement expectations would help preserve these principles as experience with TAVR for native AR continues to evolve.”
Click here to read the full letter.
What is next?
CMS has said it expects to share a proposal by March 2027. Stay tuned to Cardiovascular Business for more updates.
Other recent TAVR policy changes
CMS has been busy these last few months. In fact, the agency just finished finalizing several significant updates to the TAVR national coverage determination, including reduced reporting requirements and coverage for asymptomatic patients. Click here to read more about those changes.
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.