The CMS national coverage determination (NCD) for TAVR:
- Requires that both an interventional cardiologist and cardiac surgeon perform all procedures.
- Requires participation in a registry only for off label use.
- Restricts the use of TAVR to only the transfemoral approach.
- Requires an STS mortality risk score of > 20%.
Answer: A.
Rationale: This is required for all procedures via any FDA approved approach. Participation in a national registry is required for all patients irrespective of use. The NCD allows any approach be reimbursed provided the system being used and the approach have been approved by the FDA. An STS score is not specifically required but 2 cardiac surgeons who have evaluated the patient face-to-face must agree that the patient is high risk for SAVR.
References: cms.gov.
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