Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Cardiac/Circulatory Problems. 
Treatment: Durable Medical Equipment (DME)(including Wearable Defibrillators). 
The insurer denied a Zoll LifeVest. 
The denial was upheld. 

The patient is a male, who initially presented to the emergency department (ED) with shortness of breath. The patient was found to have an elevated troponin and brain (or B-type) natriuretic peptide (BNP) and was transferred to another hospital for further evaluation. The patient's electrocardiogram (ECG) was abnormal and suggestive for non-ST elevation myocardial infarction (NSTEMI). The patient was taken to the catheterization (Cath) lab on an emergent basis. His coronary angiography revealed 3 vessel coronary artery disease (CAD). His Echocardiogram revealed an ejection fraction of 20%.
His cardiac magnetic resonance imaging (MRI) scan was done and it found subendocardial myocardial scarring predominantly involving the apex of the heart as well as the lateral wall and inferior wall. Severe dyskinesia of the left ventricle with akinetic segment involving the distal left anterior descending coronary artery distribution in the region of the apex. There was less than 25% delayed enhancement of the region, the apicolateral wall of the left ventricular myocardium. The patient underwent a coronary artery bypass graft (CABG). The patient was started on guidelines directed medical management. The patient was discharged home with a LifeVest on.
The patient was seen one month after surgery, and was free of chest pain, chest tightness or chest discomfort at rest or with exertion. There were no episodes of palpitations, syncope or near syncope. No change of medical regimen was done. The patient was referred for cardiac rehabilitation and a follow up echocardiogram was scheduled. The patient was recommended to continue to wear the LifeVest.
At issue is whether the Zoll LifeVest is likely to be more beneficial than any standard treatment or treatments.

The health plan's determination regarding the proposed health service or treatment is upheld in whole.

The proposed health service or treatment Zoll LifeVest is not likely to be more beneficial than any standard treatment or treatments for the insured's life-threatening condition.
A LifeVest for prevention of sudden cardiac death is frequently used in clinical scenarios of newly diagnosed low ejection fraction, below 35%, when an implantable cardioverter defibrillator (ICD) is not being indicated yet because 90 days of optimal medical management should be attempted prior to an ICD implantation. However, multiple trials failed to support this practice, because LifeVest was not superior to medical therapy in these patients (with newly diagnosed low EF). Therefore, LifeVest is not medically necessary for primary prevention of sudden cardiac death, as in this case.
Application of LifeVest might appear to protect the patient from sudden death and gives comfort to the provider, however, it lacks any evidence of survival benefit and, despite on multiple trials, failed to be demonstrated clinically and statistically significant outcome. The latest guidelines listed indications for wearable cardioverter-defibrillator (WCD) as class IIB with level of evidence C. The service classified as IIB indications with level of evidence C means, that benefit was not demonstrated, and further studies are necessary. 
Therefore, the proposed health service of Zoll LifeVest is not likely to be more beneficial than any standard treatment.