Appeal type: Medical necessity
Decision: Overturned

Diagnosis: heart failure
Treatment: durable medical equipment
The insurer denied Zoll LifeVest - Automatic External Defibrillator with Integrated Electrocardiogram Analysis, Garment Type 
The health plan's determination is overturned in part. 

The patient is a man with a history of nonischemic cardiomyopathy and New York Heart Association Class II heart failure. His left ventricular ejection fraction (LVEF) was 31% by Single-photon emission computed tomography (SPECT) myocardial perfusion imaging. Cardiac catheterization showed a 70% stenosis in the first obtuse marginal artery. The LVEF was 30% and was reduced out of proportion to the degree of coronary artery disease. Guideline directed medical therapy for heart failure was prescribed. The patient received a LifeVest wearable cardioverter defibrillator (WCD) for primary prevention of sudden cardiac death. 

Based on the documentation provided the LifeVest wearable cardioverter defibrillator (WCD) was medically necessary for 2 months.
Depressed left ventricular systolic function is a risk factor for, and powerful predictor of, sudden arrhythmic death. Consequently, 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 man, with nonischemic cardiomyopathy and left ventricular ejection fractions of 35% or less. However, due to the possibility that left ventricular function may improve with time and/or treatment, it is recommended that device implantation be delayed for at least 90 days following the initial diagnosis of nonischemic cardiomyopathy and initiation of therapy. If, after 90 days of optimal medical therapy, the LVEF remains less than or equal to 35%, ICD implantation is then recommended. However, subset analyses of patients from the large multi-center randomized DEFINITE trial evaluating the use of ICDs in nonischemic cardiomyopathy for the primary prevention of sudden cardiac death have shown that even patients with recently diagnosed cardiomyopathy are at risk for serious ventricular arrhythmias. Accordingly, many physicians prescribe the LifeVest WCD as a "bridge" to potential ICD implantation in newly diagnosed patients. The efficacy of the WCD in detecting and terminating serious ventricular arrhythmias compares favorably to that of the implanted device. In the published clinical studies the vast majority of episodes of rapid ventricular arrhythmias were successfully treated by the device. The WEARIT-II Registry was a prospective registry that enrolled 2000 patients with cardiomyopathy who were treated with the WCD; 927 (46%) had nonischemic cardiomyopathy. The rate of sustained ventricular tachyarrhythmias that were successfully treated with the WCD by 3 months was 1% among nonischemic patients. Thus, the risk of sudden death during this relatively short time period was not insignificant and the WCD successfully mitigated this risk.
In this case, once the MUGA scan performed showed an LVEF of 37% the WCD was no longer medically necessary.