Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for a Zoll LifeVest for treatment of the enrollee who had a recent episode of tachycardia.  Findings:  2/3 of the physician reviewers found that based on the records provided, the patient has been diagnosed with a newly recognized nonischemic cardiomyopathy, a left ventricular ejection fraction of about 30 to 35% and sustained wide complex tachycardia of uncertain origin in the absence of documented syncope. In this circumstance, since the origin of the tachycardia is not clearly ventricular and may be supraventricular, further evaluation with an electrophysiology study is most appropriate to define the tachycardia prior to committing to a defibrillator (wearable of implantable).  If the tachycardia is confirmed to be supraventricular with aberrancy then a defibrillator of any kind would not be recommended at this time. Placement of a prophylactic defibrillator is not recommended until a period of time where continued left ventricular dysfunction (ejection fraction less than or equal to 35%) is documented to persist in spite of appropriate treatment. A prophylactic defibrillator, wearable or implantable, before this time has not been demonstrated to improve outcome. For example, studies assessing efficacy of prophylactic defibrillators early after diagnosis of myocardial infarction and reduced ejection fraction less than 35% before ventricular function has had a chance to recover have not demonstrated improved outcomes. Also, studies evaluating wearable defibrillators during periods of increased risk where criteria for implantable defibrillators have not yet been met are largely comprised of registry data without adequate control groups. At this time, prophylactic wearable external defibrillator would be indicated only if accepted criteria for an implantable defibrillator were met and an implantable defibrillator could not be placed or needed to be significantly delayed (due to infection, for example) or required explantation.  Accepted criteria for an implantable defibrillator would be met only if the patients sustained tachycardia is proven to be ventricular in origin. Therefore, according to current scientific literature, Zoll LifeVest is not likely to be more effective for treatment of this patient than any available standard treatment modality. Final Result: 2/3 of the reviewers determined that the requested equipment is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewer number one is board certified in internal medicine with sub-specialty certification in cardiovascular disease and is actively practicing. The reviewer is an expert 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.Physician reviewer number two is board certified internal medicine with sub-specialty certification in cardiovascular disease and is actively practicing. The reviewer is an expert 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.Physician reviewer number three is board certified in internal medicine with sub-specialty certification in cardiovascular disease and is actively practicing. The reviewer is an expert 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.