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

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for a wearable cardiovascular defibrillator (Zoll LifeVest) provided Findings:  The physician reviewer found that The patient is a patient with a history of smoking, obstructive pulmonary disease and diabetes. The patient presented with dyspnea symptoms due to congestive heart failure. The patient was evaluated with severely depressed left ventricular ejection fraction and subsequent cardiac catheterization. The report noted normal coronary arteries without stenosis. The patient was medically managed and discharged  with a wearable defibrillator.  A follow up visit  reported fatigue and exertional dyspnea.  An echocardiogram  later reported a left ventricular ejection fraction of 15%. An implantable defibrillator was placed . The patient requested reimbursement for a wearable cardiovascular defibrillator (Zoll LifeVest) provided . The Health Plan denied reimbursement noting that the device at issue was investigational for the treatment of the patients medical condition.The superior efficacy of the device at issue has not been demonstrated in this clinical setting. In this patients case, there is potential for recovery of left ventricular function over time with medical therapy and there was no indication for immediate placement of a defibrillator. The patients record did not demonstrate a sustained or inducible ventricular tachycardia, syncope or aborted sudden cardiac arrest.  Placement of a prophylactic defibrillator is not recommended until a period of time (greater than 90 days) 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 percent before ventricular function has had a chance to recover have not demonstrated improved outcomes . There is a lack of evidence to demonstrate the superior efficacy of this device over medical therapy, in this patients case. Therefore, according to scientific literature, the wearable cardiovascular defibrillator provided  was not likely to have been more effective than standard treatment options available to this patient.Final Result: The reviewers determined that the device at issue was not likely to have been 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 reviewers 1, 2 & 3 are board certified in internal medicine with sub-specialty certification in cardiovascular disease and are  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.