Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cardiomyopathy.
Treatment: Life Vest.

The insurer denied coverage for Life Vest.  The denial is upheld. 

This patient is a male with a history of hypertension, chronic kidney disease, sleep apnea, chronic obstructive pulmonary disease (COPD), and tobacco and marijuana use. He presented to the Emergency Department (ED) with shortness of breath. Echocardiogram revealed that his ejection fraction (EF) was 20%. His physician ordered a Life Vest due to risk of sudden death during a time when implantable cardioverter defibrillator (ICD) was contraindicated. The estimated period of time was for four months.

According to Centers for Medicare & Medicaid Services (CMS), a wearable defibrillator is covered with one of the four following criteria: 1) Episode of ventricular fibrillation (VF) lasting 30 seconds or longer, 2) Familial or inherited conditions with high-risk of heart attack, 3) Prior myocardial infarction (MI) or dilated myocardial or dilated cardiomyopathy and a measured left ventricular ejection fraction (LVEF) less than 35%, and 4) Previous implanted defibrillator requiring ex plantation. It was thought that this patient met criterion number 3. CMS guidelines recommend deferment of ICD implementation for at least 90 days post diagnosis to allow time for medical therapy to be optimized. 

The patient was seen by his cardiologist for reevaluation and denied chest pain or pressure, shortness of breath, dizziness or syncope. Medications included spironolactone, Plavix, atorvastatin, carvedilol, hydralazine, Coumadin and albuterol. On exam he was in no distress with no jugular venous distention. Lungs were clear with no peripheral edema. The echocardiogram done a few months prior showed an EF of 25-30%; he was on dialysis for a few months then was discontinued. He then came to the hospital with shortness of breath and abdominal swelling. Because of a history non-compliance his cardiologist did not consider use of a Life Vest. The patient was seen again to be evaluated for fistula placement for dialysis. He denied chest pain and shortness of breath. A nuclear stress test showed no evidence of reversible or non-reversible perfusion abnormality. There was no evidence of myocardial ischemia, scar or infarction. There was normal cardiac wall motion and EF of 53%. 

In the setting of newly diagnosed non-ischemic cardiomyopathy, the benefit of ICD early after diagnosis remains controversial. In a Cardiomyopathy Trial, patients with recently diagnosed non-ischemic dilated cardiomyopathy and LVEF <=0.30 derived no benefit from ICD implantation. (2) The DEFINITE study (3) failed to demonstrate statistical benefit for non-ischemic dilated cardiomyopathy, New York Heart Association (NYHA) class I to III heart failure, LVEF <=0.35, and ventricular ectopy or non-sustained ventricular tachycardia (VT). Current guidelines state that the period of time required to ascertain improvement of LV function with guideline-directed medical therapy is uncertain and that timing of ICD implantation is a decision that requires careful consideration. Patients with recent diagnosis of heart failure in whom the prospect of improvement in ventricular function is still unknown represent a population for consideration of wearable cardioverter-defibrillator (WCD). WCD therapy may be appropriate in those patients with additional risk markers for arrhythmic death, including high-grade ventricular ectopy or non-sustained ventricular tachycardia.

This patient had transient left ventricular (LV) dysfunction that had resolved and resulted in an EF of 53%. That removes a major indication for use of the Life Vest. This patient had normal LV function, no evidence of ischemia, and no family or personal history of malignant arrhythmia. 

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

Based on the above, the medical necessity for the Life Vest is not substantiated. The insurer's denial should be upheld.