Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cerebrovascular accident.
Treatment: LifeVest wearable cardioverter defibrillator.
The insurer denied the LifeVest wearable cardioverter defibrillator.
The denial is upheld.

The patient is an adult male with no prior cardiac history who was found to have a cerebrovascular accident (CVA) and cerebrovascular disease, and he was diagnosed with dilated cardiomyopathy with an ejection fraction (EF) in 30% range on echocardiogram. Cardiac catheterization revealed no obstructive coronary artery disease (CAD). The patient was started on medical therapy for management of cardiomyopathy and was prescribed LifeVest wearable cardioverter defibrillator for primary prevention of ventricular arrhythmia. His ejection fraction continued to be low, despite therapy. The patient subsequently had an automatic implantable cardioverter-defibrillator (AICD) placed.

No, the proposed LifeVest wearable cardioverter defibrillator was not medically necessary.

The LifeVest is a wearable cardioverter defibrillator (WCD) used on an outpatient basis. The LifeVest is designed to perform the same functions as an automatic implantable cardioverter defibrillator (AICD), but is worn outside the body and therefore is noninvasive. Two pivotal studies were designed to examine the safety and efficacy of the LifeVest wearable cardioverter defibrillator (WCD) system. The WEARIT study enrolled ambulatory patients typical of those awaiting a heart transplant and who had a left ventricular ejection fraction (LVEF) less than 30% and New York Heart Association (NYHA) functional Class III or IV heart failure. These patients went on to receive the heart transplant, implantation of an implantable cardioverter defibrillator (ICD), or a circulatory assist device. The BIROAD study enrolled patients who were waiting for at least four months for implantation of an implantable cardioverter defibrillator (ICD), and included patients who had experienced a recent myocardial infarction or received a coronary artery bypass graft (CABG). Additional inclusion criteria for the BIROAD study were complication of the coronary artery bypass graft (CABG) or myocardial infarction with ventricular tachyarrhythmias within 48 hours of the event, and a left ventricular ejection fraction (LVEF) less than 30% at least three days after the event; a Killip Class III or IV three days following the infarction and syncopal ventricular tachyarrhythmias two days post infarction. Although the BIROAD and WEARIT studies were initiated independently and performed in a total of 18 centers in the United States and one center in Germany, the Food and Drug Administration (FDA) requested that the two studies be combined with each group being considered as a subpopulation. Another study supporting the utility of a wearable cardioverter defibrillator (WCD) is a retrospective review of a database of 3,569 patients (mean age 59 years) who received a wearable cardioverter defibrillator (WCD) in 2002-2006. Survival of these patients was compared to that of patients who received an implantable cardioverter-defibrillator (ICD). In this study, short-term survival in patients with a wearable cardioverter defibrillator (WCD) was similar to that of patients with an implantable cardioverter defibrillator (ICD). The conclusion was that wearable cardioverter defibrillator (WCD) provides very useful temporary protection from death due to ventricular tachycardia (VT)/ventricular fibrillation (VF) in implantable cardioverter defibrillator (ICD) candidates who require 'bridging therapy,' for example, in the first 40 days after a large myocardial infarction or when an implantable cardioverter defibrillator (ICD) is explanted because of infection. 

The patient in this particular case has the diagnosis of non-ischemic dilated cardiomyopathy with an ejection fraction (EF) of less than 35%. There was no evidence of spontaneous ventricular arrhythmia, history of syncope or abnormal electrophysiology (EP) study. There was no evidence of any obstructive coronary disease or ischemia. Patients such as this one were not included in the prospective studies described above, and thus the impact on health outcomes with the use of this technology in this patient population is not known. Therefore, the use of this device in patients such as this one remains unproven, as there is no evidence from the published peer-reviewed medical literature that the technology leads to improvement in health outcomes in this patient's particular clinical scenario.