CMS Finalizes Major Updates to Medicare TAVR Coverage Rules
CMS issued a Decision Memorandum on September 10, 2026, finalizing a reconsideration of the National Coverage Determination for Transcatheter Aortic Valve Replacement, prompted by a request from device manufacturer Edwards Lifesciences. The updated NCD relaxes the 2019 rules by allowing asynchronous heart-team patient evaluations, eliminating the requirement for two operators from different specialties, replacing hospital-level volume requirements with operator-level thresholds (20 valve procedures annually, 15 of which must be TAVR), and ending coverage-with-evidence-development requirements for symptomatic severe aortic stenosis. CMS also created a new coverage pathway for asymptomatic severe aortic stenosis, limited to CMS-approved studies. Hospitals and physicians performing TAVR must comply with the revised conditions of Medicare payment, as noncompliance can trigger False Claims Act exposure.
Hospitals and cardiac programs must update credentialing, staffing, and documentation practices to meet the new operator-level volume and evaluation standards or risk Medicare payment denials and False Claims Act liability.
Finance
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