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.

This patient has a past medical history which includes breast cancer, status post bilateral mastectomy, prophylactic partial hysterectomy, insomnia, and depression. She presented with 2-3 months of progressive exertional dyspnea despite outpatient treatment for pneumonia, as well as orthopnea and paroxysmal nocturnal dyspnea, with significant unexpected weight gain. She was admitted, with an initial evaluation notable for hyponatremia, transaminitis, and elevated brain natriuretic peptide (BNP), and with a physical exam suggestive of heart failure and volume overload. Abdominal computed tomography (CT) scan revealed hepatomegaly with trace ascites. Ultimately, hepatic, and renal failure were attributed to hypoperfusion from left ventricle (LV) dysfunction.

The patient presented with cardiogenic shock from severe non-ischemic cardiomyopathy, was initially treated with Impella and milrinone, and was stabilized. She was discharged with milrinone infusion and LifeVest.   

The LifeVest has clinically relevant approval from the appropriate regulatory bodies. The LifeVest was approved by the Food and Drug Administration (FDA), with approvals for multiple incremental improvements since that time.  Clinical indications are driven by national guidelines. In this case, the relevant guidelines are the science advisory from the American Heart Association and endorsed by the Heart Rhythm Society,  and the American Heart Association/ American College of Cardiology/ Heart Rhythm Society (AHA/ACC/HRS) guidelines (referenced above). In those documents, appropriate criteria for use of wearable cardioverter defibrillation (WCD) include "Patients with newly diagnosed nonischemic cardiomyopathy with severely reduced LV systolic function (LVEF [left ventricular ejection fraction] less than or equal to (<=) 35 percent) that is potentially reversible", or "Patients with severe heart failure who are awaiting heart transplantation." Both of these diagnoses applied to the patient at the time of her diagnosis, making the use of the WCD appropriate in her care, as approved by the relevant regulatory bodies for her diagnosis.

This patient is a reasonable candidate for the LifeVest device, by virtue of her non-ischemic cardiomyopathy with LVEF less than (<) 30%, and the scientific data supporting its use in this population. See question #1 for a summary of the relevant evidence.

The LifeVest device was the best available treatment for this patient at this time. She was initially not yet a candidate for ICD with her recent diagnosis and the hope that LVEF would improve over time. WCD is an appropriate and medically indicated treatment for bridging to ICD or transplant. A more complete response is that the LifeVest device, coupled with appropriate medical therapy and ongoing evaluation for additional intervention, is actually the best available treatment for this patient at this time. 

The requested service is likely to be more beneficial than any of the standard treatments/ procedures for this patient. In an important sense, the requested service actually represents the standard treatment/ procedures for this patient. As noted, the evidence is not as clear as it would be in other conditions and is not definitive. At the current time, however, with the imperfect evidence currently available, use of the LifeVest in a case such as patient's is a part of the treatment strategy most likely to be beneficial to her.

Some adverse risks (notably the risk of inappropriate shock, or the discomfort associated with any shock) are increased with the use of a defibrillator, whether wearable or internal. Of course, these risks need to be considered in comparison with the potential benefits. In this case, it is reasonable to conclude that overall risk to the health of the patient is likely to be reduced using the LifeVest, not increased, when compared to standard treatment/services.

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