Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chest Pain

Treatment: Durable Medical Equipment

The insurer denied wearable cardiac defibrillator.

The denial was upheld.   

The patient is a patient who presented to the emergency department (ED) because of chest pain. The pain had been constant since the previous night and was associated with nausea and pain with motion. The patient has a past medical history of diabetes mellitus type II. They have no pertinent surgical history and review of systems is negative except for what has been mentioned above. The patient had a cardiac catheterization performed. The indication was ST elevation myocardial infarction (STEMI). The procedure was done through the left femoral vein access. An intra-aortic balloon was inserted. A 99% lesion was found in the proximal left anterior descending (LAD) artery and the drug eluting (DES) was inserted. The circulation was right dominant and there was moderate mid vessel disease of a large right coronary artery (RCA). There was also 70% stenosis of the left main coronary artery and disease in a moderately sized left circumflex (LCx) artery. No complications occurred during the Cath Lab visit. Vital signs include BP 120/82, pulse 92, respirations 20, oxygen saturation 92% and body mass index (BMI) 22.11. On physical exam the patient is described as alert and in no acute distress with no jugular venous distension (JVD), no cardiac murmurs and normal breathing with no rales or rhonchi. Laboratory results obtained included WBC 6.55, hematocrit 41.8, sodium 139, potassium 3.8, BUN 21 and creatinine 0.6. An EKG showed sinus rhythm at 91 bpm, probable left atrial enlargement, borderline left axis deviation, acute anterior infarct with ST segment elevation, consider inferior injury since lateral leads are also involved. Assessment and plan states that the patient has a STEMI and non-insulin-dependent diabetes mellitus type II. The plan was to admit the patient to the intensive care unit (ICU) and plan urgent cardiac catheterization. Aspirin and brilinta were given. Vital signs listed on 7/5 include blood pressure (BP) 85/69, pulse 90, temperature 100.2, respirations 26 and oxygen saturation 97%. The patient was described as comfortable and in no apparent distress. Pulmonary exam revealed crackles at the bases and an S4 was noted. An echocardiogram was performed. The summary describes the left ventricle as having a normal cavity size and regional wall motion abnormalities are present. The left ventricular ejection fraction (LVEF) is moderately reduced and was 35-40%. There is akinesis of the apical septum, apical lateral, apical inferior, and apical anterior and mid to basal anterior septum myocardium. Right ventricle (RV) systolic function is normal. The mitral annulus is mildly calcified and there is trace mitral regurgitation (MR). There is one plus tricuspid regurgitation (TR) and a small pericardial effusion is present. Laboratory data include hematocrit 35.5, sodium 138, potassium 3.7, BUN 20 and creatinine 0.5 is glucose was 172.His medications at the time of discharge include aspirin, Lipitor, metformin, metoprolol and brilinta. A note states that they cannot give the patient beta blockers or ACE inhibitors because of low blood pressure. The patient's creatinine is 0.7 and they plan to give the patient a life vest pre-discharge.

A 2016 AHA Science Advisory states that despite their obvious benefits, current defibrillator technologies have limitations and risks.  Wearable Cardioverter Defibrillators (WCDs) can serve as a temporary means of aborting arrhythmic death in patients with transient risk of sudden cardiac death (SCD) or those with indications for ICD implantation who have a transient barrier to permanent device implantation. Providers need to keep many factors in mind and to continuously weigh the individual risks and benefits of ICD placement and WCDs in their patients. Furthermore, discussion of patient preferences is an integral part of patient care and WCD therapy. Further research, including randomized trials, is needed to better inform the optimal use of WCD therapy. (1)

Despite the high rate of sudden death after myocardial infarction among patients with a low ejection fraction, implantable cardioverter-defibrillators are contraindicated until 40 to 90 days after myocardial infarction. Whether a wearable cardioverter-defibrillator would reduce the incidence of sudden death during this high-risk period is unclear.

Implantable cardioverter-defibrillator (ICD) therapy has been shown to improve survival in patients with various heart conditions who are at high risk for ventricular arrhythmias. Whether benefit occurs in patients early after myocardial infarction is unknown. Investigators conducted the Defibrillator in Acute Myocardial Infarction Trial, a randomized, open-label comparison of ICD therapy (in 332 patients) and no ICD therapy (in 342 patients) 6 to 40 days after a myocardial infarction. They enrolled patients who had reduced left ventricular function (left ventricular ejection fraction, 0.35 or less) and impaired cardiac autonomic function (manifested as depressed heart-rate variability or an elevated average 24-hour heart rate on Holter monitoring). The primary outcome was mortality from any cause. Death from arrhythmia was a predefined secondary outcome. During a mean (+/-SD) follow-up period of 30+/-13 months, there was no difference in overall mortality between the two treatment groups: of the 120 patients who died, 62 were in the ICD group and 58 in the control group (hazard ratio for death in the ICD group, 1.08; 95 percent confidence interval, 0.76 to 1.55; P=0.66). There were 12 deaths due to arrhythmia in the ICD group, as compared with 29 in the control group hazard ratio in the ICD group. (2)

A 2018 NEJM study randomly assigned (in a 2:1 ratio) patients with acute myocardial infarction and an ejection fraction of 35% or less to receive a wearable cardioverter-defibrillator plus guideline-directed therapy (the device group) or to receive only guideline-directed therapy (the control group). The primary outcome was the composite of sudden death or death from ventricular tachyarrhythmia at 90 days (arrhythmic death). Secondary outcomes included death from any cause and non-arrhythmic death. Of 2302 participants, 1524 were randomly assigned to the device group and 778 to the control group. Arrhythmic death occurred in 1.6% of the participants in the device group and in 2.4% of those in the control group. Death from any cause occurred in 3.1% of the participants in the device group and in 4.9% of those in the control group, and non-arrhythmic death in 1.4% and 2.2%, respectively. Of the 48 participants in the device group who died, 12 were wearing the device at the time of death. A total of 20 participants in the device group (1.3%) received an appropriate shock, and 9 (0.6%) received an inappropriate shock. These investigators concluded that among patients with a recent myocardial infarction and an ejection fraction of 35% or less, the wearable cardioverter-defibrillator did not lead to a significantly lower rate of the primary outcome of arrhythmic death than control. (3)

The literature cited indicates that the only randomized trial concerning the Life Vest was recently concluded and did not show any significant difference in the primary endpoints.  The only justification for use of this device includes ICD ex-plantation for infection or lead displacement or contraindications to an ICD such as systemic infection that would temporarily delay an ICD implantation or being on the waiting list for heart transplantation. None of these conditions were present in this patient. The current medical literature does not support the use of the Life Vest that was requested for three months. 

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

The carrier's denial of coverage for Life Vest (K0606) x 3 months is upheld.  The medical necessity is not substantiated.