Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: End-Stage Non-Ischemic Cardiomyopathy

Treatment: LifeVest device (procedure code K0606)

The insurer denied coverage for LifeVest device (procedure code K0606)

The denial is overturned.

The patient has a history of breast cancer, bilateral mastectomy and chemotherapy that presented to the hospital complaining of dyspnea, weight gain and orthopnea.  On exam she was noted to be fluid overloaded. She reported pruritis and excoriation and ecchymosis were noted over her entire abdomen.  She was diagnosed with acutely decompensated right and left heart failure, acute kidney injury, and shock liver with Aspartate transaminase (AST/ALT) (1156/1008 respectively).  Electrocardiogram (ECG) revealed normal sinus rhythm with a QRS (interval on ECG) duration of 130 milliseconds and a prolonged corrected QT (interval on ECG) interval of 486. Cardiac catheterization revealed no significant coronary disease.  Right heart catheterization revealed a capillary wedge pressure of 42 with a cardiac index of 1.1.  Echocardiogram revealed an left ventricular ejection fraction (LVEF) of 20% (percent) with moderate to severe mitral regurgitation and moderate tricuspid regurgitation. The patient was treated with an impella device and milrinone.  She was ultimately sent home on intravenous (IV) milrinone with an external life vest defibrillator while GDMT [guideline directed medical therapy] was up titrated. Consideration for LVAD [left ventricular assistive device] and additional therapies were to take place once the patient was on maximal medical therapy.

The scientific evidence in peer reviewed literature supports a result of improvement in health outcome. 

The LIfeVest defibrillator is approved for patients at risk for sudden cardiac death that are not eligible for ICD [implantable cardioverter defibrillator] implantation.

This patient is a good candidate for the lifevest. The LifeVest device is the best available for the patient while the patient is on home milrinone therapy and guideline directed medical therapy is adjusted. There are no adverse risks to lifevest defibrillator therapy. This therapy is likely to be more beneficial to the patient than any other standard treatment.

External lifevest defibrillator for a patient presenting with right and left systolic congestive heart failure and cardiogenic shock requiring home milrinone therapy is supported by general medical community and the peer reviewed literature.  Such therapy is both safe and efficacious. 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 therapy. (Reference 1) However patients enrolled in SCDHFT were in cardiogenic shock requiring home inotropic therapy.  Such patients are ineligible for implantable defibrillator therapy.  Prior to implanting an ICD, patients must be treated with guideline directed medical therapy for at least 3 months in an attempt to allow for ventricular remodeling and improve LVEF.  If medical therapy is effective, then patients often do not require device implantation. (Reference 2) During this period of treatment, patients are at risk for sudden cardiac death and must be protected.  External lifevest defibrillator therapy provides such protection. Guideline statements from the Heart Rhythm Society/American Heart Association and the American College of Cardiology specify that external lifevest defibrillator therapy should be utilized during periods when patients are at risk of sudden cardiac death and require further cardiac workup/treatment. (References 3-5) A recent real-world study of patients treated with external lifevest defibrillators, almost 5% of subjects received lifesaving therapy. (Reference 6). Current American Heart Association/ American College of Cardiology (AHA/ACC) guidelines support the use of the lifevest defibrillator therapy for patients that are ineligible for ICD such as those waiting for transplant or LVAD.  (7) In conclusion wearable lifevest defibrillator therapy is medically necessary and likely to be more beneficial than any other standard therapy. 

The carrier's denial of the LifeVest device (procedure code K0606) provided should be overturned.