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Darius Lakdawalla, Barry Liden and colleagues responded to the Centers for Medicare and Medicaid Services’ request for comment on the agency’s reconsideration of the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) 20.32. The authors also provided comments on how CMS could implement an improved, predictable approach to Coverage with Evidence Development (CED) policy.
Their recommendations include:
- Establish a transparent framework with objective, pre-specified criteria for evaluating when CED requirements have been satisfied and should be retired.
- Enforce time limits on CED, ensuring that requirements do not extend beyond five years without compelling justification.
- Incorporate validated patient preference data into decisions about both the application and termination of CED requirements.
- Consider patient access implications of NCD requirements, particularly their impact on underserved populations.
Read the full comment letter here.
