Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: ST (interval on an ECG) elevation myocardial infarction (STEMI).
Treatment: Zoll Life Vest, code K0606.
The insurer denied coverage for Zoll Life Vest, code K0606.
The denial is upheld.

This case involves a male diagnosed with coronary atherosclerosis, hyperlipidemia, and myocardial infarction (MI) who underwent transthoracic echocardiogram due to a history of coronary artery disease. A critical finding included that the patient's left ventricular ejection fraction (LVEF) was 30%. Systolic pressure was mildly to moderately increased and estimated to be 50 mmHg (millimeters of mercury). There was hypokinesis of the anteroseptal myocardium and of the mid-apical anterolateral myocardium, of the mid-apical anterior myocardium, and diastolic dysfunction. The discharge summary stated that the patient had presented with crushing substernal chest pain for 30 minutes and radiation to the right arm along with diaphoresis. He was treated with aspirin, intravenous eptifibatide, heparin drops, and underwent right heart catheterization/ left heart catheterization (RHC/LHC) and was found to have 100% occlusion of the proximal left anterior descending artery (LAD). He had 4 x 15 mm (millimeter) drug eluting stent (DES) x1 placed, with the procedure complicated by post catheter hypotension requiring Levophed. He had intra-aortic balloon pump and Swan-Ganz catheter (SGC) placed. After being titrated off pressors, hemodynamics remained stable the following day. IABP (intra-aortic balloon pump) and SGC (soluble guanylate cyclase) were removed and eptifibatide was transitioned to Brilinta. The transthoracic echocardiogram showed reduced ejection fraction of 25 to 30% with hypokinesis of the anteroseptal myocardium. The patient was started on guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) due to ischemic cardiomyopathy (ICM).  He was given Toprol-XL 25 mg (milligrams) daily, losartan 25 mg daily, Aldactone 12.5 mg daily, with plans to continue aspirin 81 mg daily along with Brilinta 90 mg twice a day, and atorvastatin 80 mg. The patient had a LifeVest placed for primary prevention of sudden cardiac death (SCD) prior to discharge. 

Current medical literature states that the use of a wearable cardioverter defibrillator (WCD) is reasonable when there is a clear indication for an implanted/permanent device accompanied by a transient contraindication or interruption in implantable cardioverter defibrillator (ICD) care, such as infection. Use of the WCD's is reasonable as a bridge to more definitive therapy, such as cardiac transplantation. Indications are not well excepted to include ischemic cardiomyopathy with LVEF below 35% before reassessment, recent onset of an ICM or presumed myocarditis with LVEF less than or equal to 35% before reassessment, after ICD (implantable cardioverter-defibrillator) explant until reimplantation, and bridge to transplant. 

The literature does not support a result of improvement and health outcome for patients of this population. The Zoll Life Vest does not have final approval from the appropriate regulatory bodies for this diagnosis. According to medical literature, this patient is not a good candidate for Zoll Life Vest. The Zoll Life Vest is not the best available treatment for this patient at this time. The adverse risks are not increased over standard treatment/services.

The requested service is not likely to be more beneficial than any of the standard treatment/procedures for this patient.

The carrier's denial of coverage for Zoll Life Vest, code K0606 should be upheld.