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September 14, 2026

CMS Issues Final NCD on Coverage of TAVR for Severe Aortic Stenosis

KEY TAKEAWAYS

  • CMS issues final NCD on TAVR that removes the CED requirements for TAVR in patients with symptomatic severe AS.
  • Medicare coverage now extends to asymptomatic severe AS under CED requirements.
  • The final NCD removes hospital procedural volume requirements and permits TAVR to be performed by a single operator.

September 14, 2026—The Centers for Medicare & Medicaid Services (CMS) issued the updated the National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR).

As outlined in the NCD, the updates do the following:

  1. Cover TAVR for symptomatic severe aortic valve stenosis (aortic stenosis; AS) without the coverage with evidence development (CED) requirement
  2. Expand coverage of TAVR to asymptomatic severe AS with CED
  3. Revise coverage criteria related to preprocedural patient assessment, intraoperative requirements, and operator and hospital procedural volume requirements.

The final NCD is available on the CMS website.

SCAI President J. Dawn Abbott, MD, posted an analysis of the key changes in the NCD. It compared how these changes compare with member feedback that SCAI received during the development of the NCD. Also, Dr. Abbott advised that next steps include SCAI continuing to advocate with CMS to ensure proper implementation of the new coverage decision and associated payment.

Finally, Dr. Abbott noted that although the final decision did not address coverage for aortic regurgitation (AR), CMS has opened a separate NCD decision memo to evaluate AR and create a separate coverage policy. SCAI will participate in this NCD process and submit comments.

As outlined by Dr. Abbott, the key changes in the final NCD address the following issues:

  • Heart team requirements. The decision memo maintains a heart team requirement while providing greater flexibility in how evaluations are conducted. CMS will require an in-person evaluation by the TAVR operator, while allowing greater flexibility for other Heart Team members to participate in the evaluation process.
  • Modernizing the current framework. The final decision includes several significant changes that modernize the current framework, including removal of CED requirements for symptomatic severe AS; coverage of TAVR for asymptomatic severe AS under CED requirements; revised operator competency requirements; and removal of hospital procedural volume requirements.
  • Operator flexibility. The final decision removes the requirement that TAVR procedures be performed by both an interventional cardiologist and a cardiac surgeon. Under the decision, TAVR procedures may be performed by a single operator. Additionally, when the heart team deems two operators are necessary, coverage is provided as long as both are part of the heart team. The two operators can be any combination of interventional cardiologists and cardiac surgeons.
  • Quality oversight and registry reporting. The final decision continues to emphasize quality oversight and program infrastructure requirements designed to monitor patient outcomes and support continuous quality improvement while removing specific reporting mandates.
  • Program requirements. The final decision removes hospital procedural volume requirements and instead focuses on program infrastructure and quality processes. These include on-site structural heart interventional cardiology and cardiac surgery programs; intensive care capabilities appropriate for managing patients undergoing surgical aortic valve replacement; and continuous quality improvement processes that assess procedural outcomes and support patient safety.
  • CED. The final decision removes CED requirements for patients with symptomatic severe AS while maintaining CED requirements for the newly proposed coverage indications of asymptomatic severe AS.

Additionally, a joint statement on the final NCD was released by SCAI, the American College of Cardiology (ACC), and the Society of Thoracic Surgeons (STS) that included the following comments:

“The ACC, STS, and SCAI appreciate CMS’s efforts to evolve Medicare coverage for TAVR and enhancing access to more patients as the evidence supporting this therapy continues to grow.

“As TAVR expands into new patient populations, it is critical to preserve the quality framework that has contributed to its success. The preservation of the Heart Team, continued collaboration across specialties, collection of real-world evidence outcomes, monitoring, and continuous quality improvement are the foundation of ensuring and improving outcomes for our patients with severe AS.

“Participation in national registries, externally benchmarked quality programs and rigorous outcomes reporting remain essential to preserving the high standards of care that have defined TAVR’s success. The societies will continue to support the STS/ACC TVT Registry and other quality initiatives that promote evidence generation, patient safety, continuous improvement, and health care value across the cardiovascular community.”

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