Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Abnormal Heart Function, Chronic Heart Failure with Reduced Ejection Fraction
Treatment: Wearable Automatic External Defibrillator
The insurer denied the request for the Wearable Automatic External Defibrillator.
The health plan's determination is overturned.

The patient is a male with a history of hypertension, hyperlipidemia and diabetes. He was hospitalized with decompensated heart failure. His electrocardiogram showed a left bundle branch block. An echocardiogram was performed. The study was suboptimal due to poor acoustic windows. The left ventricle was dilated and globally hypokinetic with an estimated left ventricular ejection fraction (LVEF) of 30 to 39 percent (%). 

The health plan, in its determination of medical necessity, did not act reasonably, with sound medical judgment and in the best interest of the patient. 

Yes, the requested health service and treatment of the wearable automatic external defibrillator is medically necessary for the patient. Myocardial perfusion imaging showed no evidence of ischemia. The resting LVEF was 33% and with exercise it was 32%. The patient was treated with guideline directed medical therapy for heart failure with reduced ejection fraction. 

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 patient, 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 optimization of medical 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 Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (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. Antiarrhythmic drugs have not been shown to mitigate this risk. Accordingly, many physicians prescribe the LifeVest WCD as a "bridge" to potential ICD implantation in newly diagnosed patients. The efficacy of the WCD (Wearable Cardioverter Defibrillator) 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 Prospective Registry of Patients Using the Wearable Cardioverter Defibrillator (WEARIT-II) was a prospective registry that enrolled 2000 patients with cardiomyopathy who were treated with the WCD; 927 (46 percent (%)) had nonischemic cardiomyopathy. The rate of sustained ventricular tachyarrhythmias that were successfully treated with the WCD by 3 months was 1% among nonischemic patients. The meta-analysis by Masri, et al, reported that 6% of patients with nonischemic cardiomyopathy experienced an appropriate and successful WCD shock during a three-month period. Thus, the risk of sudden death during this relatively short time period was not insignificant and the WCD successfully mitigated this risk.