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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 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 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 determines when a counter shock is necessary. The alarm module alerts the patient to certain conditions by lights or voice messages, during which time a conscious patient can abort or delay the shock.
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 the Zoll® LifeVest®.
In 2015, FDA approved the LifeVest® “for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent.”
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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).
06/06/2016: Policy number added. Policy Guidelines updated to add medically necessary and investigative definitions.
06/21/2016: Policy description updated regarding devices. Policy statements unchanged.
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.