Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The enrollee has requested reimbursement for the wearable cardioverter defibrillator for treatment of the enrollees dilated cardiomyopathy.  Findings:  The physician reviewer found that Based on the records provided the patient presented with newly recognized severe left ventricular dysfunction in the setting of troponin elevation, respiratory failure and no obstructive coronary disease. 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 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 (ejection fraction  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. 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. All told, the wearable cardioverter defibrillator provided was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: Two of three 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.