Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Myocardial Infarction

Treatment: Zoll Life Vest - Code K0606

The insurer denied coverage for Zoll Life Vest - Code K0606

The denial is overturned

Reviewer #3:

This is a patient who reported dyspnea and chest pain. The patient was initially found to have a rhythm consistent with ventricular tachycardia on rhythm strip as performed by Emergency Medical Services (EMS) and was subsequently diagnosed with non-ST elevation myocardial infarction (NSTEMI). The patient underwent coronary artery bypass grafting (CABG) for severe three-vessel coronary artery disease. At the time of the bypass, the patient had a significant ischemic cardiomyopathy, with a left ventricular ejection fraction (LVEF) of ~20% (percent), and a posterior left ventricular aneurysm. Due to their severe cardiomyopathy and associated shock, an Impella (a form of left ventricular support) was implanted at the time of surgery and removed 1 week later.

Zoll (the company that manufactures and sells the LifeVest) sent an appeal letter. They include the Centers for Medicare and Medicaid Services (CMS) criteria for use of a LifeVest, one of which is prior myocardial infarction (MI) or dilated cardiomyopathy with LVEF < Less-than 35% . They include a literature review indicating the high risk of ventricular arrhythmias and death in the early post-op phase for patients such as the patient, the effectiveness of the LifeVest in treating these arrhythmias, and two studies (one at Cleveland Clinic, the other the VEST trial) demonstrating significant outcome improvements - including mortality at 90 days, and reduction in sudden death - in patients using the LifeVest. They mention the Class IIb recommendation from the American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Rhythm Society (HRS) guidelines for use of the LifeVest in patients such as this patient. 

The scientific evidence in peer-reviewed literature does support a result of improvement in health outcomes. However, the IIb indication and Level B Non-Randomized (B-NR) evidence level are consistent with a very incomplete body of literature regarding this particular patient population - every study that can be cited to show a benefit has issues that make application to the patient's case challenging. The picture is not nearly as clear as that presented by Zoll in their literature review. Despite that caveat, the preponderance of evidence falls on the side of likely benefit. 

These facts, in total, support the use of a Wearable Cardioverter Defibrillator (WCD) for the patient.

The patient is a reasonable candidate for the LifeVest device, by virtue of his ischemic cardiomyopathy with LVEF <30%, and the scientific data supporting its use in this population. See question #1 for a summary of the relevant evidence.

The requested service is likely to be more beneficial than any of the standard treatments/ procedures for this patient. In an important sense, the requested service actually represents the standard treatment/ procedures for this patient. Use of the LifeVest in a case such as the patient's is a part of the treatment strategy most likely to be beneficial to them.

In summary, the denial of Zoll Life Vest - Code K0606 and coverage for the requested treatment should be reversed. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.