Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Nonischemic cardiomyopathy
Treatment: LifeVest wearable cardioverter defibrillator
The insurer denied the LifeVest wearable cardioverter defibrillator.
The determination is overturned.

The patient was admitted to the hospital with acute decompensated heart failure. Her medical history was remarkable for diabetes, hypertension, hyperlipidemia, cigarette smoking and morbid obesity. An echocardiogram showed a left ventricular ejection fraction of 25-30% (percent). An electrocardiogram showed left bundle branch block. The patient was diagnosed with nonischemic cardiomyopathy. Guideline-directed medical therapy for heart failure with reduced ejection fraction was initiated. At the time of hospital discharge a LifeVest wearable cardioverter defibrillator (WCD) was prescribed. The medical necessity for the WCD is under review.

The use of the WCD for this patient was medically necessary.
This patient presented to the hospital with decompensated heart failure and a markedly reduced left ventricular 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 the 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 left ventricular ejection fraction (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.
The patient did not meet the New York State Medicaid criteria for medical necessity for the wearable cardioverter defibrillator. Per the policy provided the device is considered medically necessary for patients with dilated cardiomyopathy and left ventricular ejection fractions of 35% or less when:
1)	There is a contraindication or temporary condition that precludes implantation of an implantable cardioverter defibrillator (ICD), such as infection; (NOT MET)
2)	A previously implanted ICD has been removed and re-implantation is planned when medically appropriate; (NOT MET)
3)	Less costly appropriate alternatives have been explored; (MET; there are no equally effective alternative treatments)
4)	The device was prescribed by a cardiologist with experience in managing patients at risk for sudden cardiac death. (NOT MET; the prescriber was not a physician)
Although the policy criteria were not met, use of the WCD in this care was supported by the medical literature. Therefore, the use of the WCD for this patient was medically necessary.