Transcatheter Aortic Valve Replacement

The CMS CERT program produces a national Medicare FFS error rate, as required by the Improper Payments Information Act. CMS strives to eliminate improper payments in the Medicare Program to maintain the Medicare trust funds and protect patients. If a claim is found to be in error, payment will be retracted.

We are providing you with this reminder as a result of several errors identified through the CERT program related to the NCD for transcatheter aortic valve replacement (TAVR) (20.32).

NCD 20.32 establishes comprehensive requirements which must be met in order for the TAVR to be considered reasonable and necessary. In particular, there is a need to ensure the hospital record reflects that, “Two cardiac surgeons have independently examined the patient face-to-face and evaluated the patient's suitability for open aortic valve replacement (AVR) surgery; and both surgeons have documented the rationale for their clinical judgment and the rationale is available to the heart team.”

Please note there are many other requirements within NCD 20.32 which must also be met. Briefly, these other requirements include:

1. The valve and implantation system that has received FDA approval;
2. The patient (preoperatively and postoperatively) is under the care of a heart team which meets the requirements listed in the NCD regarding volume, availability of related services and personnel, and other qualifications;
3. The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intraoperative technical aspects of TAVR;
4. The heart team and hospital are participating in a prospective, national, audited registry.

Please review the full text of NCD 20.32 available through the Medicare Coverage Database found on the CMS website