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December 16, 2019 - Updated 04.06.20

Documentation Reminder for TAVR

Transcatheter Aortic Valve Replacement (TAVR): This procedure is used for the treatment of aortic stenosis when furnished according to the Food and Drug Administration (FDA)-approved indications.

The Comprehensive Error Rate Testing (CERT) contractor has issued errors resulting in a denial of inpatient claims due to missing documentation to support the need for the TAVR procedure. CERT Reviewer Comments include: The submitted medical records were missing evidence that two cardiac surgeons had independently examined the patient face-to-face and evaluated the patient's suitability for open aortic valve replacement (AVR) surgery. Both surgeons must document the rationale for their clinical judgment and that the rationale was available to the heart team.

Please review the NCD 20.32, Transcatheter Aortic Valve Replacement (TAVR) Please review the NCD 20.32, Transcatheter Aortic Valve Replacement (TAVR) for ALL RECENT coverage updates which include in part:

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. 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. The heart team includes the following:
    1. Cardiac surgeon and an interventional cardiologist experienced in the care and treatment of aortic stenosis who have:
      1. independently examined the patient face-to-face, evaluated the patient's suitability for surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy;
      2. documented and made available to the other heart team members the rationale for their clinical judgment.
    2. Providers from other physician groups as well as advanced patient practitioners, nurses, research personnel and administrators.
  3. The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR.
  4. TAVR must be furnished in a hospital with the appropriate infrastructure that includes but is not limited to:
    1. On-site heart valve surgery and interventional cardiology programs,
    2. Post-procedure intensive care facility with personnel experienced in managing patients who have undergone open-heart valve procedures,
    3. Appropriate volume requirements per the applicable qualifications below:

Providers should ensure that all documentation to support the medical necessity for this procedure is submitted when requested by CERT and other Medicare contractors.

References

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