Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Myocardial infarction

Treatment: Automatic Wearable Defibrillator (Procedure code K0606)

The insurer denied coverage for the Automatic Wearable Defibrillator (Procedure code K0606).

The denial is overturned. 

This is a male patient who presented to the hospital with an acute anterior wall myocardial infarction (MI) and had a ventricular fibrillation arrest on the way to the hospital requiring antiarrhythmic therapy and external defibrillator shocks to restore normal rhythm. Cardiac catheterization revealed multi-vessel coronary artery disease with an occluded left anterior descending (LAD). The patient underwent revascularization and was treated for reduced left ventricular ejection fraction (LVEF). Relevant past medical history included end-stage renal disease (ESRD) status post kidney transplant, hypertension (HTN) and benign prostatic hypertrophy (BPH). Following revascularization, the patient's LVEF was noted to be 25-30%.

External LifeVest defibrillator for a patient presenting with MI complicated by ventricular fibrillation requiring emergent external defibrillation is supported by peer-reviewed literature, meets regulatory approval from the appropriate regulatory bodies and is the best available treatment for this patient.  In addition to ventricular fibrillation arrest, this patient had newly diagnosed systolic congestive heart failure with a LVEF of 25-30%.  The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) clearly demonstrated that such patients have a significant risk of sudden cardiac death and benefit from implantable cardioverter-defibrillator (ICD) therapy. Prior to implanting an ICD, patients must be treated with guideline directed medical therapy for at least three months in an attempt to allow for ventricular remodeling and improve LVEF. This particular patient had a ventricular fibrillation arrest in the setting of an acute myocardial infarction (MI) and he is not a candidate for immediate ICD implantation. If medical therapy is effective in increasing LVEF then patients often do not require device implantation. During this period of treatment, patients are at risk for sudden cardiac death and must be protected.  External LifeVest defibrillator therapy provides such protection. Guideline statements from the Heart Rhythm Society/American Heart Association and the American College of Cardiology specify that external LifeVest defibrillator therapy should be utilized during periods when patients are at risk of sudden cardiac death and require further cardiac workup/treatment.

The Vest Prevention of Early Sudden Death Trial (VEST) specifically studied patients at risk of sudden cardiac death following myocardial infarction.  In an as treated analysis wearing a LifeVest defibrillator was associated with a 57% reduction in arrhythmic death and a 74% reduction in mortality.

Based on the review of the medical record and literature, the requested service is likely to be more beneficial than any of the standard treatments/procedures for this patient.

The carrier's denial of coverage for the Automatic Wearable Defibrillator (Procedure code K0606) should be overturned.