Noridian was notified by the CERT Review Contractor of errors related to Left Atrial Appendage Closure (LAAC) claims. In the cases reviewed, documentation did not demonstrate that the required formal shared decision-making interaction had occurred.

Please review the Indications and Limitations of Coverage from the National Coverage Determination (NCD) 20.34 which includes in part:

2. Nationally Covered Indications
   The Centers for Medicare & Medicaid Services (CMS) covers percutaneous LAAC for non-valvular atrial fibrillation (NVAF) through Coverage with Evidence Development (CED) with the following conditions:
   1. LAAC devices are covered when the device has received Food and Drug Administration (FDA) Premarket Approval (PMA) for that device's FDA-approved indication and meet all of the conditions specified below:
      The patient must have:
      • A formal shared decision-making interaction with an independent non-interventional physician using an evidence-based decision tool on oral anticoagulation in patients with NVAF prior to LAAC.

The shared decision-making interaction must be documented in the beneficiary's medical record.

All documentation supporting medical necessity must:

• Be legible
• Maintained in the patient's medical record
• Meet all Medicare signature requirements
• Be made available to the A/B MAC or other CMS review entity upon request.

Reference:

• CMS National Coverage Determinations (NCD) 20.34