Diagnosis: Ischemic Cardiomyopathy, Coronary Artery Disease
Treatment: Wearable automatic external defibrillator life vest (K0606RR)
The insurer denied coverage for wearable automatic external defibrillator life vest (K0606RR).
The denial is upheld.

This is a male patient with a history of ischemic cardiomyopathy, hypertension, coronary artery disease status post percutaneous intervention (PCI) with 2 stents and myocardial infarction (2018) with PCI x 3 and hypertension. The patient's echocardiogram performed showed an ejection fraction (EF) of 30-35%. A Life Vest was ordered, with an estimated length of need of 4 months. Per the Treatment Plan, there was a planned date to re-assess the patient's EF. The patient was waiting for an echocardiogram and EF after his last percutaneous coronary intervention, while being managed medically. The plan was to reassess his EF and to place an implantable cardioverter device (ICD) as indicated by his EF.

The Life Vest is FDA approved for prevention of sudden cardiac death. However, the use of Life Vest for the dates under review is not medically necessary. The patient was diagnosed with ischemic cardiomyopathy, with ejection fraction of 30-35%. This technology has not been shown to be clinically beneficial when compared with standard-of-care medical therapy for prevention of sudden cardiac death in patients with newly diagnosed cardiomyopathy. For the dates under review, Life Vest technology is not medically necessary. There is no clinical research evidence documenting incremental benefit of this technology over conventional medical therapy in prevention of sudden cardiac death. This technology would therefore be considered experimental and/or investigational in this clinical setting and does not represent the standard of care for such patients. The patient's clinical presentation and the absence of extenuating circumstances do not support the medical necessity for use of the requested, Life
Vest for the dates under review.

The health plan acted reasonably with sound medical judgment, and in the best interest of the patient.

Based on the above, the medical necessity for wearable automatic external defibrillator life vest (K0606RR) is not substantiated. The insurer's denial should be upheld.