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A wearable cardioverter-defibrillator (WCD) is a temporary, external device that is an alternative to an implantable cardioverter-defibrillator (ICD). It is primarily intended for temporary conditions for which an implantable device is contraindicated, or for a period of time during which the need for a permanent implantable device is uncertain.
Sudden cardiac arrest (SCA) is the most common cause of death in patients with coronary artery disease. The implantable cardioverter defibrillator (ICD) has proven effective in reducing mortality for survivors of SCA and for patients with documented malignant ventricular arrhythmias. More recently, the use of ICDs has been potentially broadened by studies reporting a reduction in mortality for patients at risk for ventricular arrhythmias, such as patients with prior myocardial infarction (MI) and reduced ejection fraction. ICDs consist of implantable leads in the heart that connect to a pulse generator implanted beneath the skin of the chest or abdomen. ICD placement is a minor surgical procedure, with the ICD device placed under the skin on the chest wall and the cardiac leads placed percutaneously. Potential adverse effects of ICD placement are bleeding, infection, pneumothorax, and delivery of unnecessary countershocks. See the Automatic Implantable Cardioverter Defribrillator policy for further information.
The wearable cardioverter defibrillator (WCD) is an external device that is intended to perform the same tasks as an ICD, 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 countershock. 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 determines when a countershock 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." The vest was renamed and is now called the Zoll® LifeVest®.
Use of wearable cardioverter-defibrillators for the prevention of sudden cardiac death is considered medically necessary as interim treatment for those who:
Use of wearable cardioverter-defibrillators for the prevention of sudden cardiac death is considered investigational for the following indications when they are the sole indication for a wearable cardioverter-defibrillator:
Use of wearable cardioverter-defibrillators is considered investigational for all other indications.
Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
It is uncommon for patients to have a temporary contraindication to ICD placement. The most common reason will be a systemic infection that requires treatment before the ICD can be implanted. The wearable cardioverter-defibrillator should only be used short-term while the temporary contraindication (eg, systemic infection) is being clinically managed. Once treatment is completed, the permanent ICD should be implanted.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
11/2003: Approved by Medical Policy Advisory Committee (MPAC)
1/21/2004: Code Reference section completed
3/22/2005: Code Reference section updated, CPT code 93741, 93742, 93745 added non-covered codes
11/16/2006: Policy archived
1/2/2007: Policy clarified and re-activated
1/9/2007: Code reference section updated. Non-covered table deleted. Codes moved to covered with note to see Policy section for medically necessary and investigational indications. Added ICD-9 codes 425.1, 426.81-426.89, 427.0, 427.1, 427.41, 427.42, 427.81, 427.89, and 427.9.
4/29/2008: Policy reviewd, no changes.
12/31/2008: Code Reference section updated per 2009 CPT/HCPCS revisions
08/17/2010: Policy description unchanged. Medically necessary policy statement re-worded for clarity, and the statement regarding awaiting a heart transplant and have a contraindication to placement was removed. FEP verbiage added to the Policy Exceptions section. Deleted outdated references from the Sources section. Added CPT code 93292 to the Covered Codes table. Removed CPT codes 93741 and 93742 from the code table as they were deleted as of 12/31/2008.
12/29/2010: Policy reviewed; no changes.
01/17/2012: Policy reviewed; no changes.
12/13/2012: Policy reviewed; no changes.
04/14/2014: Policy reviewed; removed "have all of the following" from the medically necessary policy statement. Added "post-CABG surgery, newly diagnosed nonischemic cardiomyopathy, women with peripartum cardiomyopathy, and high-risk patients awaiting heart transplant" to investigational policy statement. Added additional policy statement that "Use of wearable cardioverter-defibrillators is considered investigational for all other indications." Policy title changed from "Wearable Cardioverter Defibrillators as a Bridge to Implantable Cardioverter-Defibrillator (ICD) Placement" to "Wearable Cardioverter-Defibrillators."
02/09/2015: Policy description updated regarding devices. Policy statement unchanged. Policy guidelines updated regarding temporary contraindications to ICD placement.
08/31/2015: Medical policy revised to add ICD-10 codes. Added fifth digit to ICD-9 diagnosis code 425.1 (425.11).
Blue Cross Blue Shield Association policy # 2.02.15
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.