Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Non-ischemic cardiomyopathy. 
Treatment: Life Vest (Automatic External Defibrillator, CPT Code K0606 RR x four months). 

The insurer denied the Life Vest (Automatic External Defibrillator, CPT Code K0606 RR x four months). 
The denial is upheld. 

The patient is a female.  At the time of admission, she has a past medical history significant for CLL (chronic lymphocytic leukemia), DVT (deep venous thrombosis) and pulmonary embolism, arterial embolism, s/p (status post) embolectomy, atrial fibrillation and flutter. She was diagnosed with non-ischemic cardiomyopathy, with EF (ejection fraction) 15-20% by echocardiogram. There was no history of ventricular tachycardia or fibrillation. The patient was prescribed Life Vest Wearable Automatic External Defibrillator for primary prevention. 

No, the Life Vest (Automatic External Defibrillator, CPT Code K0606 RR x four months) is 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 (ICD), but is worn outside the body and therefore is noninvasive. 

Two pivotal studies were designed to examine the safety and efficacy of the LifeVest WCD system. The WEARIT study enrolled ambulatory patients typical of those awaiting a heart transplant and who had an LVEF (left ventricle ejection fraction) < (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 ICD, or a circulatory assist device. The BIROAD study enrolled patients who were waiting for four months for implantation of an ICD and included patients who had experienced a recent MI (myocardial infarct) or received a coronary artery bypass graft (CABG). Additional inclusion criteria for the BIROAD study were complication of the CABG or MI with ventricular tachyarrhythmias within 48 hours of the event, an LVEF < 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 postinfarction. 

Although the BIROAD and WEARIT studies were initiated independently performed in a total of 18 centers in the United States and one center in Germany, the FDA (Food and Drug Administration) 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 is a retrospective review of a database of 3,569 patients (mean age 59 years) who received a WCD in 2002-2006. Survival of these patients was compared to that of patients who received an ICD. In this study, short-term survival in patients with a WCD was similar to that of patients with an ICD. The conclusion was that WCD provides very useful temporary protection from death due to VT/VF (ventricular tachycardia/ventricular fibrillation) in ICD candidates who require 'bridging therapy,' for example, in the first 40 days after a large myocardial infarction or when an ICD is explanted because of infection. 

However, the most recent trial of WCD in patients with reduced EF (ejection fraction) after a myocardial infarction failed to show reduction in sudden cardiac death or arrhythmic death with the use of this device. 

The patient in this particular case has the diagnosis of non-ischemic dilated cardiomyopathy with EF of less than 35%. There was no evidence of spontaneous ventricular arrhythmia, history of syncope or abnormal EP (electrophysiology) study. There was no evidence of any obstructive coronary disease or ischemia. Patients such as this 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 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. There are no high-grade peer reviewed meta-analyses or randomized controlled trials of WCD for patients with cardiomyopathy during the "waiting period" prior to permanent ICD (implantable cardioverter defibrillator) implantation. The strategy of prescribing WCD (wearable cardioverter defibrillator) to all patients with cardiomyopathy awaiting recovery of LV (left ventricle) function or permanent ICD thus far has not been shown to be beneficial. Therefore, the medical necessity of the proposed treatment cannot be established.