BlueCross and BlueShield of Montana Medical Policy/Codes
Automatic External Defibrillators (AEDs) (Wearable and Nonwearable)
Chapter: Medicine: Treatments
Current Effective Date: February 01, 2014
Original Effective Date: May 09, 2008
Publish Date: January 15, 2014
Revised Dates: March 1, 2010; October 1, 2011; December 6, 2012; May 27, 2013; January 15, 2014
Description

Sudden cardiac arrest (SCA) is the most common cause of death in patients with coronary artery disease. The automatic implantable cardioverter defibrillator (AICD) has proven effective in reducing mortality for survivors of SCA and for patients with documented malignant ventricular arrhythmias. More recently, the use of AICDs has been potentially broadened by studies reporting a reduction in mortality for patients at risk for ventricular arrhythmias, such as patients with prior MI and reduced ejection fraction. AICDs consist of implantable leads in the heart that connects to a pulse generator implanted beneath the skin of the chest or abdomen. In the past, AICD placement required a thoracotomy, but current technology allows implantation with only a minor surgical procedure, with the cardiac leads placed percutaneously. Potential adverse effects of AICD placement are bleeding, infection, pneumothroax, and delivery of unnecessary counter shocks.

The wearable AED is an external device that is intended to perform the same tasks as an AICD, without requiring invasive procedures. It consists of a vest that is worn continuously underneath the patient's clothing. Part of this vest is the ‘electrode belt’ that contains the cardiac monitoring electrodes, and the therapy electrodes that deliver a counter shock. The vest is connected to a monitor with a battery pack and alarm module that is worn on the patient’s belt. The monitor contains the electronics that interpret the cardiac rhythm and determine when a counter shock is necessary. The alarm module alerts the patient to certain conditions by lights or voice messages. The U.S. Food and Drug Administration (FDA) approved the Lifecor WCD® 2000 system via premarket application approval in December 2001 for “adult patients who are at risk for cardiac arrest and are either not candidates for or refuse an implantable defibrillator.”

A nonwearable AED is a compact device that is used to deliver an electrical shock to a victim of SCA. These units use a microprocessor inside a portable defibrillator to interpret a victim’s heart rhythm through adhesive electrodes. The computer recognizes a VF or VT and either advises the operator whether electrical defibrillation is needed, or automatically delivers electrical therapy.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coverage

Wearable automatic external defibrillators (AED’s) may be considered medically necessary when an automatic implantable cardioverter defibrillator (AICD) is contraindicated or excluded from use AND the patient is at high risk for sudden cardiac death (SCD) due to one of the conditions described below:

  1. A documented episode of ventricular fibrillation (VF) or a sustained (lasting 30 seconds or longer) ventricular tachyarrhythmia (VT). These dysrhythmias may be either spontaneous or induced during an electrophysiologic (EP) study, but may not be due to a transient or reversible cause and not occur during the first 48 hours of an acute myocardial infarction (MI); or.
  2. Familial or inherited conditions with a high risk of life-threatening VT’s such as long QT syndrome or hypertrophic cardiomyopathy; or
  3. Documented prior MI or dilated cardiomyopathy and a measured left ventricular ejection fraction (LVEF) less than or equal to .35 (35%); or
  4. A previously implanted defibrillator (ICD) requiring explantation.

Nonwearable AED’s for home use are considered experimental, investigational and/or unproven.

Rationale

There is a consensus among experts that the appropriate endpoint for studies of automatic implantable cardioverter defibrillator (AICD) is total mortality. Few peer-reviewed published studies report on clinical outcomes of wearable automatic external defibrillators, and no studies evaluate the efficacy of wearable defibrillators in reducing mortality compared to alternatives. Only one, full-length English-language manuscript was identified in the peer-reviewed literature. This study included fifteen survivors of sudden cardiac arrest (SCA), and evaluated the ability of the wearable cardioverter defibrillator (WCD) to identify and convert arrhythmias induced in the electrophysiology lab. Of the fifteen patients, ten had inducible VT or VF. The wearable defibrillator correctly sensed the arrhythmia in nine of ten cases, and delivered a successful counter shock in all nine cases that were detected.

The FDA approved the Lifecor WCD® 2000 system via premarket application approval in December 2001 based on clinical data submitted to the FDA by the manufacturer, which has subsequently been published in the peer-reviewed literature. This prospective non-randomized trial study with historical controls enrolled 289 patients who were either 1) patients awaiting cardiac transplantation, a circulatory-assist device, or a permanent AICD used the WCD as a “bridge” to these procedures; or 2) patients who were post-myocardial infarction (MI) and/or post-CABG surgery and temporarily at high risk for ventricular arrhythmias (due to documented VT/VF during the acute event, or class III or IV congestive heart failure [CHF] post-event) wore the device for up to four months, or until implantation of a permanent AICD. During 901 patient-months of device use, there were eight episodes of VT/VF detected, with six of these successfully treated with counter shock. There were six unnecessary shocks delivered by the device during this period, for a rate of 0.67% per patient-month (95% CI: 0.30–1.35). Using historical controls consisting of patients suffering SCA who called emergency services/911, a “control” rate of 25% success for surviving SCA was obtained. Assuming that the device detected all episodes of VT/VF, the FDA review determined that the device had greater efficacy than the “control” group with 90% confidence.

Contraindications to an AICD are few. According to the American Heart Association /American College of Cardiology (AHA/ACC) guidelines on AICD use, the device is contraindicated in patients with terminal illness, with drug-refractory Class IV CHF who are not candidates for transplantation, and in patients with a history of psychiatric disorders that interfere with the necessary care and follow-up post-implantation. It is not known how many patients refuse an AICD after it has been recommended for them.

The WCD avoids potential complications associated with AICD implantation, but complication rates with current techniques are low. In one large trial of AICD versus antiarrhythmic drug therapy, complications of AICD implantation in 507 patients included hematomas in 13 (2.6%), bleeding requiring transfusion or reoperation in six (1.2%), infection in 10 (2.0%), pneumothroax in 8 (1.6%), and cardiac perforation in one (0.2%). Early mortality (within 30 days of procedure) was not higher for the AICD group (2.4%) as compared to the medication group (3.5%).

The above data establish that the WCD device can detect lethal arrhythmias and can successfully deliver a counter shock in the majority of cases. However, these data do not determine the true efficacy of the device or compare the efficacy to alternative treatment(s). For nearly all patients, the alternative is an AICD, which is currently the “gold-standard” treatment for preventing sudden death. Since complications of AICD placement are low and contraindications few, it is unlikely that the WCD can improve outcomes, even in patient populations where the need for an AICD is temporary.

2005 Update

Wearable automatic external defibrillators (AEDs)

An updated literature search was performed for the period of 2003 through December 2005. An editorial accompanying publication of the results of the WEARIT and BIROAD studies suggests that the wearable automatic external defibrillator device may be considered an alternative in the following patients:

  • Bridge to transplantation (i.e., the WEARIT population),
  • Bridge to implantable device or clinical improvement (i.e., the BIROAD population),
  • Post-bypass with ejection fraction < 30%,
  • Post-bypass with ventricular arrhythmias or syncope within 48 hours of surgery, 
  • Post-myocardial infarction with ejection fraction <30%,
  • Post-myocardial infarction with ventricular arrhythmias within 48 hours,
  • After device removal for infection, during antibiotic treatment,
  • During antibiotic treatment for non-device-related systemic infection,
  • During treatment of other medical illnesses that temporarily preclude device implant,
  • Drug-related arrhythmias (during drug washout or after, during evaluation of long-term risk),
  • Patients awaiting revascularization,
  • Patients too ill to undergo device implantation,
  • Patients who refuse device therapy.

However, the following comments are relevant to the above recommendations:

  • There may be interest in the WCD in the immediate post-myocardial infarction period as a bridge to possible AICD after a 30-day period to determine the final ejection fraction. This is a novel indication for a WCD since in this population it is not considered an alternative to an AICD, which is not indicated in the immediate post-infarction period.
  • Patients awaiting transplantation either are candidates for an AICD, or if they are not candidates for an AICD due to co-morbidities, they are typically hospitalized until they are stabilized enough to undergo AICD implantation. There may be a small set of transplant candidates who are considered at high risk for arrhythmia, but who are not candidates for an AICD, but who can be managed as an outpatient. Clarification of this small subset has not been addressed in the peer-reviewed literature.

As above, there may be some patients with an unusual combination of risk factors for arrhythmia and contraindications to an AICD that would require individual evaluation.

Nonwearable AED’s

The American Heart Association states there is not enough information available yet to recommend for or against using AED’s in the home.

2013 Update

Wearable AED’s

A BCBSA TEC assessment completed in 2010 (4) concluded that the evidence is sufficient to conclude that the wearable automatic external defibrillator can successfully terminate malignant ventricular arrhythmias. First, there is strong physiologic rationale for the device. It is known that sensor leads placed on the skin can successfully detect and characterize arrhythmias. It is also established that a successful counter shock can be delivered externally. The use of external defibrillators is extensive, ranging from in-hospital use to public placement and use at home. The novelty of this device is in the way that it is packaged and utilized.

A 2013 cohort study included hospital survivors after surgical (coronary artery bypass graft surgery) or percutaneous (percutaneous coronary intervention [PCI]) revascularization with left ventricular ejection fraction ≤35% from Cleveland Clinic and national WCD registries. Kaplan–Meier, Cox proportional hazards, propensity score-matched survival, and hazard function analyses were performed. Early mortality hazard was higher among 4149 patients discharged without a defibrillator compared with 809 with WCDs (90-day mortality post–coronary artery bypass graft surgery 7% versus 3%, P=0.03; post-PCI 10% versus 2%, P<0.0001). WCD use was associated with adjusted lower risks of long-term mortality in the total cohort (39%, P<0.0001) and both post–coronary artery bypass graft surgery (38%, P=0.048) and post-PCI (57%, P<0.0001) cohorts (mean follow-up, 3.2 years). In propensity-matched analyses, WCD use remained associated with lower mortality (58% post–coronary artery bypass graft surgery, P=0.002; 67% post-PCI, P<0.0001). Mortality differences were not attributable solely to therapies for ventricular arrhythmia. Only 1.3% of the WCD group had a documented appropriate therapy. The authors conclude that patients with left ventricular ejection fraction ≤35% have higher early compared to late mortality after coronary revascularization, particularly after PCI. As early hazard seemed less marked in WCD users, prospective studies in this high-risk population are indicated to confirm whether WCD use as a bridge to left ventricular ejection fraction improvement or implantable cardioverter defibrillator implantation can improve outcomes after coronary revascularization. (5)  

In a 2013 study (6), the LifeVest (Zoll Medical, Pittsburgh, PA) device successfully treated 1.4% of >8000 post-MI patients with low LVEF wearing the WCD for at least some time in the period ICDs are to be avoided (40 days after MI; 90 days for patients who underwent acute primary revascularization). Three-fourths of shocks from the vest occurred in the first month after MI, 96% in the first three months. Of the patients receiving appropriate shocks, 91% were successfully resuscitated.

Nonwearable AED’s

Automatic external defibrillators (AEDs) have become an important component of emergency medical systems (EMS), and the availability of AEDs in public places is expanding. There is insufficient evidence in the published medical literature, however, to demonstrate that use of AEDs in the home by laypersons improves outcomes.

No additional studies were identified that change the current coverage position of this medical policy.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

425.1, 425.4, 427.1, 427.41, 427.42, 427.9

ICD-10 Codes

I42.0-I43, I47.0-I47.9,  I49.0-I49.02, I50.1-I50.9,  Z86.74

Procedural Codes: 93745, E0617, K0606, K0607, K0608, K0609
References
  1. Use of a Wearable Defibrillator in terminating Tachyarrhythmia’s in Patients at High Risk for Sudden Death:  Results of WEARIT/BIROAD. Pacing and Clinical Electrophysiology (2004 January) 27(6):4-9.
  2. Wearable Cardioverter-Defibrillators for the Prevention of Sudden Cardiac Death. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2005 June) Medicine 2.02.15.
  3. Solomon, S. D., Zelenkofske, S., et al. Sudden Death in Patient with Myocardial Infarction and Left ventricular Dysfunction, Heart Failure, or Both. The New England Journal of Medicine (2005 June) 352 (25):2581-8.
  4. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Wearable cardioverter-defibrillator as a bridge to implantable cardioverter-defibrillator treatment. TEC Assessments 2010; Volume 25, Tab 2.
  5. Epstein AE, Abraham WT, Bianco N, et al. Wearable cardioverter-defibrillator use in patients perceived to be at high risk early post myocardial infarction. J Am Coll Cardiol 2013; available at http://content.onlinejacc.org .
  6. Zishiri, E.T., Williams, S. et al. Early risk of mortality after coronary artery revascularization in patients with left ventricular dysfunction and potential role of the wearable cardioverter defibrillator. Circ Arrhythm Electrophysiol (2013 Feb) 6(1):117-28
History
October 2011 Updated Policy and added policy guidlines for implantable cardioverter-defibrillator, updated rationale and references. Policy statement change from Not Medically Necessary to Investigational. No coding changes.
December 2012 Policy updated with literature review, reference 14 added. Wording “have all of the following” stricken from medically necessary policy statement. No other changes to policy statement.  Removed 93742, E0617, E1399.  Added 93292.  Changed title from Wearable Cardioverter-Defibrillators and Automated External (AED) to Wearable Cardioverter-Defibrillators as a Bridge to Implantable Cardioverter-Defibrillator Placement.
May 2013 Policy formatting and language revised.  Title changed from "Wearable Cardioverter-Defibrillators as a Bridge to Implantable Cardioverter-Defibrillator Placement" to "Automatic External Defibrillators (AEDs) (Wearable and Nonwearable)".  Medically Necessary section updated to include specific criteria that must be met to define high risk for sudden cardiac death.  Added HCPCs code E0617 and removed CPT code 93292.
February 2014 Document updated with literature review. Coverage unchanged.
BCBSMT Home
®Registered marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. ®LIVE SMART. LIVE HEALTHY. is a registered mark of BCBSMT, an independent licensee of the Blue Cross and Blue Shield Association, serving the residents and businesses of Montana.
CPT codes, descriptions and material only are copyrighted by the American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS Restrictions Apply to Government Use. CPT only © American Medical Association.
Automatic External Defibrillators (AEDs) (Wearable and Nonwearable)