On September 10, 2026, the Centers for Medicare and Medicaid Services (“CMS”) issued a Decision Memorandum, finalizing significant updates to Medicare’s National Coverage Determination (“NCD”) for Transcatheter Aortic Valve Replacement (“TAVR”). The updated NCD makes sweeping changes as it expands coverage, reduces procedural restrictions and gives hospitals increased flexibility in organizing and delivering TAVR services.

TAVR’s Background and Evolution

TAVR is a minimally invasive alternative to Surgical Aortic Valve Replacement for patients with aortic stenosis. During TAVR, a physician inserts a bioprosthetic valve through a catheter, typically through an artery in the groin, and positions it within the patient’s diseased aortic valve. Since CMS first issued its TAVR NCD in 2012, TAVR has become the predominant method of treatment for aortic valve replacement patients with symptomatic severe aortic stenosis in the United States.

The 2012 TAVR coverage policy included requirements for a multidisciplinary heart team, face-to-face patient evaluations and joint participation by a cardiac surgeon and interventional cardiologist during the procedure. CMS revisited the NCD in 2019 but preserved the basic framework and requirements in the 2012 policy.

In December 2025, CMS announced its second reconsideration of the TAVR NCD following a formal request by Edwards Lifesciences, a manufacturer of TAVR devices. CMS sought and received public comments with extensive input from cardiac associations.

Changes Under the 2026 NCD Decision Memo

The Decision Memorandum substantially revises many aspects of the NCD including surgeon-patient evaluation requirements, dual operator requirements, volume requirements, coverage with evidence development (“CED”) requirements and registry participation requirements.

The 2019 NCD required surgeons to independently examine the patient face-to-face. The updated NCD requires that an initial evaluation is made by the heart team, but the evaluation can be asynchronous using medical records to identify patient suitability for TAVR. This evaluation method requires input from both cardiac surgery and interventional cardiology specialties. The NCD also requires that an in-person evaluation be conducted by a heart team TAVR operator. Additional evaluation by a heart team TAVR operator is not required but is covered if performed. These changes reflect the relaxed surgeon evaluation requirements for potential TAVR patients.

CMS previously required joint participation by the heart team’s interventional cardiologist and cardiac surgeon for every TAVR procedure. The NCD no longer requires two TAVR operators, but two operators are covered if determined appropriate by the heart team. CMS also stated that joint TAVR operators can be from the same specialty or different specialties. This requirement permits two interventional cardiologists, two cardiac surgeons or one of each to perform a TAVR procedure, depending on the patient’s needs and the program’s expertise. This is one of the most significant changes to the TAVR NCD.

Many comments supported imposing operator-level volume requirements instead of the hospital-level volume requirements imposed by the 2019 NCD. Specifically, public comments supported volume thresholds of 15 TAVR procedures per year, and alternatively, 30 TAVR procedures over a two-year period. CMS finalized these recommendations, stating that a TAVR operator must perform at least 20 transcatheter cardiac valve procedures, 15 of which must be TAVR, each year. Alternatively, a TAVR operator can perform 40 transcatheter cardiac valve procedures every two years, 30 of which must be TAVR. CMS stated that contemporary, retrospective and observational studies support the finalized volume requirements as favoring patient safety.

The 2019 NCD covered TAVR for symptomatic aortic stenosis through CED. Despite comments from five cardiac associations that CED requirements should remain in place, including requiring patient data collection through clinical trials or registries, the 2026 NCD ends the CED requirement for symptomatic severe aortic stenosis CMS concluded that the evidence is sufficient to cover those procedures directly under the traditional “reasonable and necessary” standard in § 1862(a)(1)(A) of the Social Security Act.

Importantly, CMS also created an express coverage pathway for asymptomatic severe aortic stenosis. That coverage remains limited to CMS-approved CED studies. CMS viewed the evidence supporting early intervention as promising and confirmed that other trials on asymptomatic patients are underway or planned.

TAVR NCD Enforcement

Compliance with the TAVR NCD requirements is a condition of Medicare payment and failure to comply may result in federal False Claims Act liability. Historically, hospitals have refunded potential overpayments for noncompliance with the NCD through voluntary refunds to applicable Medicare Administrative Contractors or have used the HHS Office of Inspector General’s (“OIG”) Self-Disclosure Protocol to self-disclose potential non-compliance with the TAVR NCD. Many of these refunds and settlements have been quite large. Current available data reflects OIG self-disclosure settlements ranging between $18 million and $24 million. With the recent updates to the NCD prior requirements in the TAVR NCD resulting in noncompliance, such as not having two TAVR operators in a TAVR procedure, are no longer problematic. However, it is difficult to determine whether OIG or DOJ will focus enforcement efforts on hospitals and operators who did not comply with the now obsolete requirements.

Practical Takeaways

The updated NCD still imposes stringent requirements, but it provides greater clinical and operational flexibility for hospitals and operators. Health care providers performing TAVR should ensure that their TAVR programs and practices are in compliance with the updated TAVR NCD. Ensuring quality care and safe outcomes should remain the highest priority. CMS makes clear that many of its updates streamline operational requirements, with the goal of improving efficiency and access while maintaining quality care.

If you have questions about current or past TAVR practices or compliance with the NCD or if you would like more information about this topic, please contact:

Special thanks to summer associate, Matt Moller, for his assistance with the preparation of this article.

Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.

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