Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cardiac/Circulatory. 
Treatment: Durable Medical Equipment. 

The insurer denied LifeVest. 
The denial is overturned in whole. 

The patient is a male with antiphospholipid syndrome who was hospitalized with an acute ST segment elevation myocardial infarction, likely due to thromboses in the left anterior descending (LAD) and left circumflex arteries due to subtherapeutic international normalized ratio (INR). Despite thrombectomy and balloon angioplasty, flow could not be restored past the mid LAD. His left ventricular ejection fraction (LVEF) was 27% by cardiac magnetic resonance imaging (MRI). He was treated with guideline directed medical therapy for heart failure with reduced ejection fraction. His hospital course was complicated by multiple cerebral emboli and acute kidney injury. By echocardiogram, his LVEF was 25%. A LifeVest wearable cardioverter defibrillator (WCD) was prescribed for three months. Medical necessity for a WCD is at issue. 

The health plan's determination is overturned. 

Sudden arrhythmic death is common in the early post-myocardial infarction period, especially in the first 30 days. The risk is highest in patients with heart failure, left ventricular dysfunction, or both. Accordingly, there has been considerable interest in interventions that might modify this risk. Studies using anti-arrhythmic drugs have been disappointing. The DINAMIT trial (Defibrillators in Acute Myocardial Infarction Trial) was a multicenter, randomized, prospective study designed to assess the impact of implantable cardioverter defibrillator (ICD) implantation, in addition to optimal medical therapy (OMT) vs OMT alone, on all-cause mortality in high-risk patients within 40 days after infarction. Of 14,609 patients, 903 died suddenly, and 164 were resuscitated after cardiac arrest. The risk was highest in the first 30 days - 1.4 percent. Patients with a left ventricular ejection fraction of 30 percent or less were at highest risk in this early period. However, there was no significant difference in all-cause mortality between the two groups. While the risk of sudden arrhythmic death was significantly lower in patients randomized to the ICD arm of the study than in the control group, this reduced risk was offset by an increase in nonarrhythmic death in the ICD arm of the study, compared with the control group. It is for this reason that current guidelines do not support ICD implantation within the first 40 days after myocardial infarct. A 40 day "waiting period" is recommended, in hopes that healing might result in improved left ventricular function. If revascularization is performed, a 90 day waiting period is recommended. In order to provide a "safety net" for high risk post-infarction patients during this time period, many physicians recommend the use of a WCD as a bridge to potential ICD implantation. These devices have been shown to be highly effective in terminating ventricular tachyarrhythmias, with close to a 100% efficacy, resulting in "aborted sudden death" as opposed to sudden death. 

In summary, the medical literature supports the use of the WCD in this patient. Use of the LifeVest wearable cardioverter defibrillator (WCD) was medically necessary.