Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the Zoll LifeVest durable medical equipment for treatment of the enrollees dilated cardiomyopathy. Findings:  2/3 of the physician reviewers found that based on the records provided the patient is a 65-year-old male who presented with heart failure and coronary ischemia treated with coronary bypass and left ventricular aneurysmectomy with a post-operative left ventricular ejection fraction of 25-30%. In this circumstance, there is potential for recovery of left ventricular function over time with medical therapy and there was no documented indication for immediate placement of a defibrillator such as sustained or inducible ventricular tachycardia, unexplained syncope or aborted sudden cardiac arrest. Placement of a prophylactic defibrillator is not recommended until a period of time (>90 days) where continued left ventricular dysfunction with an ejection fraction of  35% is documented to persist in spite of appropriate treatment. A prophylactic defibrillator either wearable or implantable before this time has not been demonstrated to improve outcome. Medical studies assessing efficacy of prophylactic defibrillators early after diagnosis of myocardial infarction and reduced ejection fraction  35% before ventricular function has had a chance to recover have not demonstrated improved outcome. 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, needed to be significantly delayed or required explantation. Therefore, the Zoll LifeVest durable medical equipment was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Final Result: 2/3 of the reviewers determined that the device at issue was 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 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 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.