Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Cardiomyopathy
Treatment: LifeVest (K0606)
The insurer denied the LifeVest (K0606)
The denial is upheld

This male with newly diagnosed congestive heart failure (CHF) from an ischemic cardiomyopathy (ICM) was approved for wearable cardioverter defibrillator (WCD) therapy during the waiting period while he was treated with guideline-directed medical therapy (GDMT) until reevaluated for implantable cardioverter defibrillator (ICD) therapy. His past medical history (PMH) is pertinent for left ventricular ejection fraction (LVEF) of 30-35% and coronary artery disease (CAD) by cardiac catheterization. He underwent five vessel (5v) coronary artery bypass grafting (CABG) surgery. An extension for coverage for wearable cardioverter defibrillator (WCD) was requested for additional time, but was denied as investigational and not medically necessary by his medical plan and the patient is appealing the decision.

No, the health plan should not cover the proposed treatment.
The proposed treatment, extended wearable cardioverter defibrillator (WCD) use after coronary artery bypass grafting (CABG) surgery is investigational and therefore, is not medically indicated.

No, the requested health service or treatment is not more beneficial than any standard treatment for the insured's condition or disease.
The paper by Chung et al. published in the Journal of the American College of Cardiology (JACC) entitled "Aggregate National Experience With the Wearable Cardioverter-Defibrillator Event Rates, Compliance, and Survival" reported the outcomes in greater than (>)3,500 patients from the Zoll manufacturer's database who wore this device between 08/2002 and 12/2006. The patients included those with a left ventricular ejection fraction of 35% or less and had recent coronary bypass surgery.  The authors and the editorial by Ralph J. Verdino MD on this topic concluded that wearable cardioverter defibrillator (WCD) is a technology that can save lives if prescribed for the correct patients, but wearable cardioverter defibrillator (WCD) should not be routinely prescribed for this particular patient subgroup since the outcomes have not been shown to be improved. 

The CABG Patch Trial, a clinical trial that evaluated prophylactic use of implanted cardiac defibrillators for ventricular arrhythmias after coronary artery bypass grafting (CABG) surgery, showed no evidence of improved survival among patients with coronary heart disease, a depressed left ventricular ejection fraction and an abnormal signal-averaged electrocardiogram in whom a defibrillator was implanted prophylactically at the time of elective coronary bypass surgery, as well. 

Therefore, wearable cardioverter defibrillator's (WCDs) effectiveness remains unproven in this particular clinical situation for patients with a left ventricular ejection fraction of 35% or less and had recent coronary bypass surgery. It is not considered standard treatment by the medical community, based on clinical evidence reported by the peer-reviewed medical literature and by generally recognized academic experts. The current peer-reviewed medical literature does not demonstrate improved health outcomes with wearable cardioverter defibrillator (WCD) compared to conventional medical therapy, such as ace inhibitors, aspirin, statins and beta-blockers for this patient group during the implantable cardioverter defibrillator (ICD) waiting period. Several clinical trials have demonstrated that alterations of heart rate variability with ace inhibitors and beta-blockers have a beneficial effect on mortality and often there is significant recovery of left ventricular systolic function over time following surgical myocardial revascularization in these patients making implantable cardioverter defibrillator (ICD) therapy not indicated. Thus, the requested health service or treatment is not more beneficial than any standard treatment for the insured's condition or disease, based on the submitted information and the current published medical literature evidence-based standards.