Noridian has received notification of recent CERT reviews for TAVR claims with identified errors related to the cardiac surgeon evaluation requirement. A recurring issue occurs when documentation includes only one independent cardiac surgeon evaluation or when both evaluations are completed by the same surgeon. These situations do not meet Medicare coverage requirements and may result in claim denials.

To be compliant with the National Coverage Determination (NCD 20.32) requirement for TAVR, documentation would include two individual evaluations, performed by two separate cardiac surgeons, with the rationale for their clinical judgement, and signature by the authoring cardiac surgeon.

All documentation supporting medical necessity must be:

• Legible
• Maintained in the patient's medical record
• Meet all Medicare signature requirements
• Available to the A/B MAC or other CMS review entity upon request

Please review the Indications and Limitations of Coverage from the National Coverage Determination (NCD) 20.32 which includes in part:

2. National Covered Indications
   The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED) with the following conditions:
   1. TAVR is covered for the treatment of symptomatic aortic valve stenosis when furnished according to a Food and Drug Administration (FDA)-approved indication and when all of the following conditions are met
      1. The procedure is furnished with a complete aortic valve and implantation system that has received FDA premarket approval (PMA) for that system's FDA approved indication.
      2. 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.
      3. The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multi-disciplinary, team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care.

Reference

• CMS NCD 20.32 - Transcatheter Aortic Valve Replacement (TAVR)