Zoll Life Vest Wearable Cardioverter Defibrillator denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: A 50-year-old female enrollee has requested reimbursement for the Zoll LifeVest wearable cardioverter defibrillator.The American College of Cardiology (ACC) and American Heart Association (AHA) guidelines note that patients with recent myocardial infarction, newly diagnosed nonischemic cardiomyopathy, recent revascularization, myocarditis, and secondary cardiomyopathy are at increased risk of sudden cardiac arrest. Patients who may benefit from automatic emergency cardioversion-defibrillation but do not meet indications for ICD implantation at the time of presentation include those who are at perceived increased risk of sudden cardiac death due to severe left ventricle dysfunction but for whom there may be optimism for clinical improvement, and those who have a clear indication for ICD but who have a contraindication to immediate placement.

Findings: The physician reviewer found that An enrollee has requested reimbursement for Zoll LifeVest external defibrillator. The records indicate that this patient was provided a Zoll LifeVest wearable cardioverter defibrillator for secondary prevention of sudden cardiac death in the setting of newly diagnosed severe ischemic cardiomyopathy, recently initiated on guideline directed medical therapy, and with an estimated high risk of sudden cardiac death that has the potential to evolve over time. The American College of Cardiology (ACC) and American Heart Association (AHA) guidelines noted that patients with recent myocardial infarction, newly diagnosed nonischemic cardiomyopathy, recent revascularization, myocarditis, and secondary cardiomyopathy are at increased risk of sudden cardiac arrest.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement and prospective authorization and coverage for a wearable cardioverter defibrillator (Zoll LifeVest). Findings: Two of the three physician reviewers found that there is a lack of support for the device at issue in this clinical setting. 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 greater than 90 days where continued left ventricular dysfunction is documented to persist despite appropriate treatment.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Zoll LifeVest wearable cardioverter defibrillator. Findings: The physician reviewer found that wearable defibrillator is a vest-like device worn under the clothing that continuously monitors heart rhythm, automatically delivers an electric shock when ventricular tachycardia (VT) or ventricular fibrillation (VF) is detected and is meant to be worn 24-hours a day except when bathing. The U.S. Food and Drug Administration (FDA) approves the use of a wearable automated external defibrillator for patients at risk for sudden arrhythmic death who are not candidates for an implantable defibrillator.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Zoll Life Vest Wearable Cardioverter Defibrillator, then check the rights and deadlines that apply to your plan.