Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Acute decompensated heart failure
Treatment: Automatic External Defibrillator with Integrated Electrocardiogram analysis (garment type)
The insurer denied Automatic External Defibrillator with Integrated Electrocardiogram analysis (garment type)
The determination is overturned.

This is a male patient who was hospitalized with acute decompensated heart failure. An echocardiogram showed a left ventricular ejection fraction (LVEF) of 15-25 percent (%) and severe mitral regurgitation. His electrocardiogram showed sinus rhythm with a right bundle branch block. Cardiac catheterization showed severe multi-vessel coronary artery disease with an LVEF of 20%. Guideline directed medical therapy for heart failure was prescribed. The patient was discharged with a LifeVest wearable cardioverter defibrillator (WCD). The patient underwent coronary artery bypass graft surgery and mitral valve replacement. Approximately three months after surgery, a repeat echocardiogram showed an LVEF of 30%. The patient had New York Heart Association Functional Class III symptoms. He underwent implantation of a biventricular implantable cardioverter defibrillator. The medical necessity for the WCD is at issue.
Based on the documentation provided the wearable cardioverter defibrillator was medically necessary.
This patient presented with congestive heart failure and a markedly reduced left ventricular ejection fraction (LVEF) due to multi-vessel coronary artery disease. Depressed left ventricular systolic function is a risk factor for, and powerful predictor of, sudden arrhythmic death. Therefore, implantation of an implantable cardioverter defibrillator (ICD) for the primary prevention of sudden cardiac death is a widespread practice, proven to be beneficial to heart failure patients with a variety of cardiac diagnoses. Current guidelines support ICD implantation in patients, such as this patient, with ischemic cardiomyopathy and left ventricular ejection fractions of 35% or less. However, due to the possibility that left ventricular function may improve with revascularization, it is recommended that device implantation be delayed for at least 90 days following coronary artery bypass graft surgery or percutaneous coronary intervention. If, 90 days post-revascularization, the LVEF remains less than or equal to 35%, ICD implantation is then recommended. However, the degree to which revascularization mitigates the risk for serious ventricular arrhythmias during this 90 day period is unclear. Accordingly, many physicians prescribe the LifeVest wearable cardioverter defibrillator (WCD) as a "bridge" to ICD implantation in these patients. The efficacy of the WCD in terminating serious ventricular arrhythmias compares favorably to that of the implanted device. In one large retrospective study of patients with left ventricular ejection fractions of 35% or less after coronary artery bypass graft surgery (CABG) or percutaneous intervention (PCI), the WCD was associated with a lower 90-day mortality in patients after CABG (no WCD: 7% vs WCD: 3%) and after PCI (no WCD: 10% vs WCD: 2%). Per the 2016 Science Advisory from the American Heart Association, use of the WCD in cases such as this one is a reasonable approach.
In this case, the patient wore the WCD while awaiting surgery, which was reasonable and medically necessary. He then continued to wear it until he had an echocardiogram approximately three months postoperatively and until his ICD implantation could be scheduled and performed. Thus, the use of the device was appropriate and medically necessary.