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DESCRIPTIONSudden 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 myocardial infarction (MI) and reduced ejection fraction. AICDs consist of implantable leads in the heart that connect 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, 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 AICD, without requiring any 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."
POLICYUse of wearable cardioverter-defibrillators for the prevention of sudden cardiac death is considered medically necessary as interim treatment for those who have all of the following:
Use of wearable cardioverter-defibrillators for the prevention of sudden cardiac death is considered investigational for all other indications, including use immediately following an acute myocardial infarction (i.e., less than 40 days).
POLICY EXCEPTIONSFederal 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.
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.
POLICY HISTORY11/2003: 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.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.02.15
CODE REFERENCEThis 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.