Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Dyspnea

Treatment: ZOLL LifeVest current procedural terminology (CPT) code K0606 (x [times] 3 months)

The insurer denied coverage for ZOLL LifeVest CPT code K0606 (x3 months).
 
The denial is upheld.

This is a patient with a history of coronary artery disease, coronary artery bypass graft surgery, and hypertension that presented to the hospital complaining of dyspnea on exertion. He was recently treated for right lower lobe pneumonia at another hospital with antibiotic therapy. On examination, vital signs were stable, BP (blood pressure) was 131/98 mmHg (millimeters of mercury) and the pulse was 91 bpm (beats per minute). Lungs were noted to be clear, and no abnormal findings were noted. A CXR (chest xray) demonstrated a right lower lobe infiltrate. Serum blood testing revealed an elevated troponin level of 30. Echocardiogram prior to presentation revealed an LVEF (left ventricular ejection fraction) of 30% (percent). Repeat echocardiogram on admission to the hospital revealed an LVEF Of 20-25%. Home medications revealed that the patient was treated with guideline directed medical therapy for heart failure with reduced ejection fraction. Cardiac recommendations included treatment with diuretics and dobutamine followed by cardiac catheterization to assess bypass grafts. Cardiac catheterization revealed triple vessel coronary artery disease with patent bypass grafts. The patient was treated with farxiga and entresto and discharged with a wearable LifeVest defibrillator. 

This patient presented with severely depressed LVEF and decompensated heart failure. Past medical history was significant for ischemic cardiomyopathy and a depressed LV (left ventricular) ejection fraction that was 30% despite adequate guideline directed medical therapy. The SCD-HFT (Sudden Cardiac Death in Heart Failure) trial clearly demonstrated that such patients have a significant risk of sudden cardiac death and benefit from ICD (Implantable cardioverter defibrillator) therapy. (Reference 1) Cardiologists must always attempt to treat reversible causes of cardiomyopathy prior to implanting an ICD. (Reference 2) During this period of diagnostic testing and treatment, patients are at risk for sudden cardiac death and must be protected. External LifeVest defibrillator therapy provides such protection while physicians determine whether treatment will result in an improvement in cardiac function. Ultimately, if medical therapy fails to result in an improvement in this patient's LVEF and functional class then an implantable device would be recommended. Guideline statements from the Heart Rhythm Society/American Heart Association and the American College of Cardiology specify that wearable LifeVest defibrillator therapy should be utilized during periods when patients are at risk of sudden cardiac death and require further cardiac workup/treatment. (References 3-4) However, a wearable LifeVest defibrillator is not indicated when patients have a class I (one) indication for ICD implant. In conclusion, wearable defibrillator therapy is not medically necessary.  In this case, an ICD should have been implanted.

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

The insurer's denial of coverage for the ZOLL LifeVest current procedural terminology (CPT) code K0606 (x [times] 3 months) is upheld. Medical necessity is not substantiated.