Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atrial Fibrillation with Rapid Ventricular Response, Ischemic Cardiomyopathy and Non-Sustained Ventricular Tachycardia 
Treatment: Wearable Cardioverter Defibrillator
The insurer denied the Wearable Cardioverter Defibrillator. The denial was upheld. 

This is a middle age male who presented to the Emergency Department in early 2019 after being seen at his PMDs office where he complained of shortness of breath. He stated that he had been having shortness of breath since 2018 when it had been treated as COPD. His shortness of breath was noted to be worse when he was in the supine position; his dyspnea was worse on exertion and was accompanied by some left-sided chest pain. It was reported that he had an 18 pounds weight gain in the last 112 months. He had a past medical history of COPD, an active smoker, hypertension, liver disease, and Barrett's esophagus. His past surgical history includes an appendectomy, hernia repair and right knee surgery.  Cardiology consulted the patient.  A Chest x-ray was performed which showed possible left sided infiltrates and upper airway vascular redistribution. His EKG showed atrial fibrillation at a rate of 146 bpm with ventricular premature beats/contractions (VPC). Another EKG 40 minutes later showed atrial fibrillation (AF) at 101 bpm in addition to VPC's. A CT angiogram of the chest was done which revealed no evidence of pulmonary emboli but did show mild CHF superimposed on COPD with a small bilateral pleural effusion. Echocardiogram showed severe bi- atrial enlargement with evidence of a small patent foramen ovale with left to right shunt, moderate mitral regurgitation and moderate pulmonary hypertension. His Left ventricular ejection fraction was 20-25%. It was suggested that the medical plan was to treat his new onset atrial fibrillation with rapid ventricular response. It was determined that the alarm on the life vest was precipitated by the rapid ventricular response. The manufacturer was contacted to increase the rate threshold to deliver a shock. The patient's medications were adjusted and he was discharged home when medically stable.

The results of the VEST trial were presented in March 2018, at the ACC annual meeting and recently published in the NEJM.  The results showed there was no significant difference in the primary endpoint rate between the WCD and control groups (1.6 vs. 2.4 percent). Total mortality was 3.1 percent in the WCD group and 4.9 percent in the control group. For the secondary endpoint of overall non-sudden death, there was no significant difference between groups.(5)

This patient had evidence of a non-ischemic cardiomyopathy possibly due to atrial fibrillation with a rapid ventricular response. The literature cited indicates that the only randomized trial concerning the Life Vest was recently concluded and did not show any significant difference in the primary endpoints.    Therefore, there is no proven evidence of medical necessity for the Life Vest for this patient's condition. In addition, since a recent randomized trial did not show any benefit for the life vest for this patient's clinical condition.  The health plan acted reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage for wearable cardioverter defibrillator services is upheld. The medical necessity is not substantiated.