Cardiologists and surgeons share early feedback after CMS proposed sweeping TAVR changes
The U.S. Centers for Medicare and Medicaid Services (CMS) made a big splash June 15 when it proposed substantial changes to current transcatheter aortic valve replacement (TAVR) coverage policies. If finalized, these changes are expected to transform patient care by significantly increasing patient access to TAVR and changing the decision-making process for U.S. care teams.
The initial responses to this proposal have been a mix of excitement and disappointment.
Background on the proposed TAVR changes
CMS first announced it was reviewing possible changes to the current TAVR national coverage determination (NCD) back in December. The agency had already revisited the NCD once in 2019, but a formal request from Edwards Lifesciences prompted this latest look.
After receiving feedback during an initial public comment period, CMS ended up proposing most—but not all—of the changes it was originally considering. Those proposals include:
- Cover TAVR in patients with asymptomatic aortic stenosis (AS)
- End coverage with evidence development (CED) requirements for TAVR in symptomatic patients
- Revise certain operator and procedural volume requirements in a way that gives care teams more flexibility.
Some other changes CMS was initially considering—such as reducing the role of cardiac surgeons—were ultimately not proposed.
Society of Thoracic Surgeons shares disappointment
The Society of Thoracic Surgeons (STS), the country’s largest medical society for the field of cardiac surgery, was one of the first groups to comment on the proposed NCD.
STS worked closely with CMS as it considered making these proposals. The group advocated for surgeons to remain a critical part of the heart team and for CED requirements to remain in place for a wide variety of patient populations.
“We are disappointed that the June 15 proposed decision memo from CMS does not fully reflect the priorities of STS,” STS President Vinay Badhwar, MD, said in a letter the society’s members. “Throughout this process, we have focused on the following over-arching goals: to protect the heart team, preserve the value of evidence-informed decisions, and avoid disruption of optimal case adoption and safety. We intend to specifically note these concerns in the open comment period.”
One of the biggest issues STS has with these proposed changes is the lack of CED requirements. Care teams were previously required to participate in clinical trials or registries if they performed TAVR, but that is no longer the case with the new-look NCD. STS is also worried that this proposal allows TAVR to be performed by a single interventional cardiologist without the assistance of a cardiac surgeon.
“Cardiothoracic surgeons bring essential expertise to the heart team,” Badhwar said. “The quality and safety standards built into the prior NCD are critical evidence-based protections for patients, particularly for complex patients and evolving indications.”
Cardiology groups share initial responses
The American College of Cardiology (ACC) and Society for Cardiovascular Angiography and Interventions (SCAI), two of cardiology’s most influential medical societies, each shared an early response to the CMS proposal. However, both groups also said they are still reviewing the document and may offer additional thoughts at a later date.
The ACC did share a quick rundown of how the proposal lines up with the group’s own recommendations for patient care. One key takeaway was the group’s continued belief that multidisciplinary heart teams play a critical role in patient care.
“The ACC remains committed to advancing policies that promote high-quality, patient-centered cardiovascular care, support appropriate access to TAVR, and reinforce strong program integrity and oversight,” the group said. “The College is reviewing the proposed decision memo and will submit formal comments before the July 15 deadline.”
Meanwhile, SCAI President J. Dawn Abbott, MD, shared the group’s perspective on the proposal and what it means for interventional cardiology going forward.
“Over the past several months, SCAI has actively engaged the interventional cardiology community through a SCAI member survey and a public town hall focused on the NCD review process,” she said in a statement. “While SCAI continues to evaluate the proposal in detail, many elements align with themes consistently emphasized by stakeholders, including the importance of preserving the heart team, maintaining appropriate quality oversight, protecting patient access, and providing greater flexibility for physicians and TAVR programs.”
Abbott pointed out that 38.4% of SCAI members polled on these issues were in favor of allowing TAVR to be performed by a single operator—no surgeon required. On the other hand, nearly 59.3% of respondents did not want to continue CED requirements for all TAVR procedures.
Advocacy group applauds changes
The Alliance for Aging Research, a U.S.-based nonprofit focused on advancing the science of aging, has also commented on the CMS proposal. The group was a vocal advocate for CMS to follow through with these changes to the TAVR NCD and shared its excitement going forward.
“The proposed updates to Medicare’s national TAVR coverage policy represent a transformative milestone for heart-valve disease patients and their families,” Sue Peschin, MHS, president and CEO of the Alliance for Aging Research, said in the group's statement. “The TAVR procedure is often preferred by patients with severe AS because it avoids open-heart surgery and allows quicker treatment and recovery. By lifting the 14-year CED requirement, CMS is formally recognizing that TAVR is reasonable and necessary for the treatment of severe, symptomatic AS.”
The Alliance for Aging Research praised other updates as well, asking CMS to “maintain this momentum and finalize these pivotal 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.