Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested a LifeVest wearable cardiovascular defibrillator for treatment of the enrollees medical condition.  Findings: Two physician reviewers found that the patient was presented with three week history of increasing dyspnea on exertion progressing to dyspnea at rest, orthopnea and paroxysmal nocturnal dyspnea. He presented with a new onset atrial fibrillation with rapid ventricular response. The patient underwent transthoracic echocardiogram and transesophageal echo (TEE) which revealed moderately severe global left ventricular (LV) dysfunction, moderately severe mitral insufficiency and left atrial appendage thrombus. The patient also underwent cardiac nuclear study which did not show active ischemia. The treating provider referred the patient for LifeVest wearable cardiovascular defibrillator placement for several months while medical therapy can be optimized prior to assessing need for permanent automated implantable cardioverter defibrillator (AICD). The Health Plan has denied the device at issue as experimental/investigational for treatment of this patient. The patient presented with atrial fibrillation and now a new diagnosis of severe symptomatic congestive heart failure (CHF) with global LV dysfunction and moderately severe mitral insufficiency. In the first few months, while he is being treated medically to try to improve his LV function, the patient is at risk for malignant arrhythmias and sudden death while the EF is low.  With time and medical therapy, perhaps eventual surgical therapy as well for mitral insufficiency, the patients EF could improve to the point where a permanent implantable cardio-defibrillator would not be indicated. If EF is not greater than 35% he would not be a candidate for a permanent AICD. In motivated patients who can manage the device, there is medical data that a wearable cardio-defibrillator can provide temporary protection from possible lethal ventricular arrhythmias in this patient population during this interim period. This short-term indication for the wearable defibrillator therapy has support from large published case series literature, a recently published longer term prospective registry, and expert opinion. In addition, in the recently published WEAR IT-II registry, many of the symptomatic ventricular tachycardia episodes were terminated with appropriate shocks and there were few inappropriate shocks (Kutyifa, et al). In this clinical situation, the patient has a severely depressed ejection fraction and needs aggressive ongoing medical treatment of his CHF and perhaps later surgical therapy of mitral insufficiency. Since current guidelines also require at least three months on optimal therapy before an LV function reassessment, and before an AICD could be placed, a wearable cardio-defibrillator is an effective treatment plan to address a short term clinical situation.  All told, LifeVest wearable cardiovascular defibrillator was and is likely to be superior over any available standard modality for treatment of this patient.Final Result: Two reviewers determined that the device at issue was and is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: All three physician reviewers are board certified in internal medicine with sub-specialty certification in cardiovascular disease and is actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.