Federal Policy·1d ago
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.