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MEDICAL POLICY 2.02.506
Wearable Cardioverter-Defibrillators as a Bridge to
Implantable Cardioverter-Defibrillator Placement
BCBSA Ref. Policy: 2.02.15
Effective Date: July 1, 2017
Last Revised: June 22, 2017
Replaces: 2.02.15
RELATED MEDICAL POLICIES:
N/A
Select a hyperlink below to be directed to that section.
POLICY CRITERIA | CODING | RELATED INFORMATION
EVIDENCE REVIEW | REFERENCES | APPENDIX | HISTORY
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Introduction
Sudden cardiac arrest is when the heart stops beating. It can
cause death within minutes if not
treated. A cardiac defibrillator is a device that shocks the
heart back into normal rhythm to
prevent sudden cardiac arrest. A wearable cardiac defibrillator
is one type of defibrillator. Its
strapped around the chest and worn underneath clothes.
Electrodes (small patches applied to
the skin) monitor the hearts rhythm. Other electrodes deliver
the current. The electrodes are
attached to a small defibrillation unit, usually worn at the
waist. When a life threatening heart
rhythm is detected, an alarm alerts the person and the
defibrillator sends a shock to return the
heart to a normal rhythm. These vests are useful when surgery to
implant a permanent
defibrillator is temporarily delayed due to a medical reason.
This policy describes when a
wearable cardioverter-defibrillator may be considered medically
necessary.
Note: The Introduction section is for your general knowledge and
is not to be taken as policy coverage criteria. The
rest of the policy uses specific words and concepts familiar to
medical professionals. It is intended for
providers. A provider can be a person, such as a doctor, nurse,
psychologist, or dentist. A provider also can
be a place where medical care is given, like a hospital, clinic,
or lab. This policy informs them about when a
service may be covered.
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Policy Coverage Criteria
Device Medical Necessity Wearable cardioverter-
defibrillator
The use of a wearable (external) cardioverter-defibrillator
(WCD) to prevent sudden cardiac arrest or death (SCD) may be
considered medically necessary as a bridge to permanent
implantable (internal) cardioverter-defibrillator (ICD)
surgery
or replacement of an ICD that was removed, when ALL of the
following criteria are met:
The criteria for an ICD placement is met (see Additional
Coverage Criteria section)
AND
A temporary contraindication to the ICD
placement/replacement surgery exists such as when:
o A current systemic infection is being treated before the
ICD
can be placed
OR
o An ICD was removed due to a current infection that is
being
treated
OR
o A new onset of nonischemic cardiomyopathy is being
treated medically for 90 days per American College of
Cardiology and the American Heart Association (ACC/AHA)
guidelines (see Additional Coverage Criteria section)
AND
The ICD placement or an ICD replacement surgery, if
appropriate, will be scheduled once the temporary
contraindication is treated or managed.
Device Investigational Wearable cardioverter-
defibrillator
Use of a wearable cardioverter-defibrillator for the
prevention
of sudden cardiac death (SCD) is considered investigational
for
all other indications not listed in the Medical Necessity
section
above, including immediately (ie, less than 40 days)
following
an acute myocardial infarction (AMI).
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Additional Coverage Criteria Temporary Contraindications for ICD
placement
A short-lived or temporary contraindication to implantable
cardioverter-defibrillator (ICD)
placement occurs infrequently. Reasons for temporary use of the
wearable (external) cardioverter-
defibrillator (WCD) include:
While a current systemic infection is being treated before the
ICD can be placed or
When an ICD was removed due to a current infection with plans
for a replacement after the
infection resolves or
While a new onset of nonischemic cardiomyopathy is being treated
medically for 90 days per
ACC/AHA guidelines.
Note: If the patient with nonischemic cardiomyopathy responds to
maximal medical treatment after 90 days, and ICD
surgery is cancelled, coverage for the WCD will stop.
American College of Cardiology and the American Heart
Association (ACC/AHA)
The ACC/AHA Guidelines state that immediate ICD placement is
contraindicated for nonischemic
cardiomyopathy until the patient has had maximal medical
treatment for 90 days.6 In some cases
the condition improves with medical treatment and the ICD
placement is no longer necessary.
Indications for Implantable Cardioverter-Defibrillator (ICD)
implantation
Indications for ICD implantation can be broadly subdivided into
two categories:
1. Primary prevention, in patients who are considered at high
risk for sudden cardiac death but
who have not yet experienced life-threatening ventricular
arrhythmia such tachycardia (VT) or
ventricular fibrillation (VF).
2. Secondary prevention, in patients who have experienced a
life-threatening episode of VT, after
reversible causes have been excluded.
Primary Prevention criteria32,33 for the use of the automatic
ICD in adults includes:
Ischemic cardiomyopathy with New York Heart Association (NYHA)
functional Class II or Class
III symptoms, a history of myocardial infarction at least 40
days before ICD treatment, and left
ventricular ejection fraction of 35% or less
OR
Ischemic cardiomyopathy with NYHA functional Class I symptoms, a
history of myocardial
infarction at least 40 days before ICD treatment, and left
ventricular ejection fraction of 30% or
less
OR
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Additional Coverage Criteria Nonischemic dilated cardiomyopathy
(NIDCM) and left ventricular ejection fraction of 35% or
less, after reversible causes have been excluded, and the
response to optimal medical therapy
has been adequately determined
OR
Hypertrophic cardiomyopathy (HCM) with one or more major risk
factors for sudden cardiac
death (history of premature HCM-related sudden death in one or
more first-degree relatives
younger than 50 years; left ventricular hypertrophy greater than
30 mm; one or more runs of
non-sustained ventricular tachycardia at heart rates of 120
beats per minute or greater on 24-
hour Holter monitoring; prior unexplained syncope inconsistent
with neurocardiogenic origin)
and judged to be at high risk for sudden cardiac death by a
physician experienced in the care
of patients with HCM.
Coding
Code Description
CPT 93292* Interrogation device evaluation (in person) with
physician analysis, review and report,
includes connection, recording and disconnection per patient
encounter; wearable
defibrillator system
93745 Initial set-up and programming by a physician of wearable
cardioverter-defibrillator
includes initial programming of system, establishing baseline
electronic ECG,
transmission of data to data repository, patient instruction in
wearing system and
patient reporting of problems or events
HCPCS
K0606 Automatic external defibrillator, with integrated
electrocardiogram analysis, garment
type
K0607 Replacement battery for automated external defibrillator,
garment type only, each
K0608 Replacement garment for use with automated external
defibrillator, each
K0609 Replacement electrodes for use with automated external
defibrillator, garment type
only, each
*Code 93292 cannot be reported with code 93745.
Note: CPT codes, descriptions and materials are copyrighted by
the American Medical Association (AMA). HCPCS
codes, descriptions and materials are copyrighted by Centers for
Medicare Services (CMS).
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Related Information
N/A
Evidence Review
Description
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.
The WCD performs the monitoring and electrical shocks like an
ICD, when a potential life-
threatening heart rhythm is detected, without requiring an
invasive procedure. The system
consists of a vest that is worn continuously underneath the
patients 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 patients 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. (See
Appendix for graphic.)
Some patients with coronary artery disease may suddenly die of a
heart rhythm disorder. 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, 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.
Background
ICDs consist of implantable leads in the heart that connects 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
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percutaneously. Potential adverse effects of ICD placement are
bleeding, infection,
pneumothorax, and delivery of unnecessary counter shocks.
The wearable cardioverter defibrillator is an external device
that is intended to perform the same
tasks as an ICD, without requiring invasive procedures. It
consists of a vest 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
worn on the patients 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.
Summary of Evidence
For individuals who have a temporary contraindication for an
implantable cardioverter
defibrillator (ICD) who receive a wearable cardioverter
defibrillator (WCD), the evidence includes
prospective cohort studies. Relevant outcomes are overall
survival, morbid events, functional
outcomes, and treatment-related morbidity. The available data
establish that the WCD device
can detect lethal arrhythmias and can successfully deliver a
countershock in most cases. A small
number of patients meet established criteria for an ICD but have
a transient contraindication for
an implantable device, most commonly an infectious process. In
patients scheduled for ICD
placement, the WCD will improve outcomes as an interim
treatment. The evidence has shown
that these patients benefit from a cardioverter defibrillator in
general, and the WCD can detect
and treat lethal arrhythmias in these patients. The evidence is
sufficient to determine
qualitatively that the technology results in a meaningful
improvement in the net health
outcome.
For individuals who are in the immediate post myocardial
infarction period who receive a WCD,
the evidence includes randomized controlled trials (RCTs) and a
technology assessment.
Relevant outcomes are overall survival, morbid events,
functional outcomes, and treatment-
related morbidity. For the immediate post myocardial infarction
period, the evidence does not
support the conclusion that the WCD improves outcomes. Two RCTs
have reported that overall
survival did not improve after treatment with a permanent ICD.
While these 2 trials both
reported a decrease in sudden cardiac death (SCD), there was a
corresponding increase in non-
SCD, resulting in no net survival benefit. Similarly, for
high-risk post coronary artery bypass graft
patients, 1 RCT reported no difference in overall survival
associated with early ICD placement.
Thus, given the lack of evidence that a permanent ICD improves
outcomes for these indications,
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a WCD is not expected to improve outcomes. The evidence is
insufficient to determine the
effects of the technology on health outcomes.
For individuals who are post coronary artery bypass graft
surgery and at high risk for lethal
arrhythmias, awaiting heart transplantation and at high risk for
lethal arrhythmias, or have newly
diagnosed nonischemic cardiomyopathy, or have peripartum
cardiomyopathy who receive a
WCD, the evidence includes case series and registry data.
Relevant outcomes are overall survival,
morbid events, functional outcomes, and treatmentrelated
morbidity. It is not possible to
conclude from the available evidence that the WCD will improve
patient outcomes. The evidence
is insufficient to determine the effects of the technology on
health outcomes.
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this
review are listed in Table 1.
Table 1: Summary of Key Trials
NCT No. Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01446965a Prevention of Sudden Death After Myocardial
Infarction
Using a LifeVest Wearable Cardioverter-defibrillator
1900 Dec 2017
NCT: national clinical trial. a Denotes industry-sponsored or
cosponsored trial
Clinical Input Received from Physician Specialty Societies and
Academic
Medical Centers
While the various physician specialty societies and academic
medical centers may provide
appropriate reviewers who collaborate with and make
recommendations during this process,
input received does not represent an endorsement or position
statement by the physician
specialty societies or academic medical centers, unless
otherwise noted.
https://www.clinicaltrials.gov/ct2/show/NCT01446965?term=NCT01446965&rank=1
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2014 Input
In response to requests, further input was received from 7
academic medical centers and 2
physician specialty societies while this policy was under review
in 2014. Input related to the role
of WCDs in preventing SCD among high-risk patients awaiting a
heart transplant. Overall, input
on the use of WCDs in this patient population was mixed. Some
reviewers indicated that it may
have a role among certain patients awaiting heart transplant,
but there was no consensus on
specific patient indications for use.
2013 Input
In response to requests, input was received from 8 academic
medical centers and 3 physician
specialty societies while this policy was under review in 2013.
Overall, the input was mixed. Most,
but not all, providing comments suggested that the WCD may have
a role in select high-risk
patients following acute MI or in newly diagnosed
cardiomyopathy. However, reviewers
acknowledged the lack of evidence for benefit and that available
evidence was not consistent in
defining high-risk subgroups that may benefit.
2010 Input
In response to requests, input was received from 4 academic
medical centers and no physician
specialty societies while this policy was under review in 2010.
Most, but not all, providing
comment suggested that the WCD may have a role in selected
high-risk patients following acute
MI or in newly diagnosed cardiomyopathy.
Practice Guidelines and Position Statements
American College of Cardiology and the American Heart
Association
(ACC/AHA)
In 2016, the American Heart Association (AHA) published a
scientific advisory on the wearable
cardioverter defibrillator (WCD).27 AHA stated that because
there is a paucity of prospective
data supporting the use of the WCD, particularly in the absence
of any published, randomized,
clinical trials, the recommendations provided in this advisory
are not intended to be prescriptive
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or to suggest an evidence-based approach to the management of
patients with FDA-approved
indications for use. The specific recommendations are summarized
in Table 2.
Table 2. Guidelines for WCD Therapy
Recommendation COR LOE
Use of WCDs is reasonable when there is a clear indication for
an implanted/permanent device
accompanied by a transient contraindication or interruption in
ICD care such as infection.
IIa C
Use of WCDs is reasonable as a bridge to more definitive therapy
such as cardiac transplantation IIa C
Use of WCDs may be reasonable when there is concern about a
heightened risk of SCD that may
resolve over time or with treatment of left ventricular
dysfunction/ for example, in ischemic heart
disease with recent revascularization, newly diagnosed
nonischemic dilated cardiomyopathy in
patients starting guideline-directed medical therapy, or
secondary cardiomyopathy (tachycardia
mediated, thyroid mediated, etc) in which the underlying cause
is potentially treatable.
IIb C
WCDs may be appropriate as bridging therapy in situation
associated with increased risk of death
in which ICDs have been shown to reduce SCD but not overall
survival such as within 40 D of MI.
IIb C
WCDs should not be used when nonarrhythmic risk is expected to
significantly exceed arrhythmic
risk, particularly in patients who are not expected to survive
>6 mo.
III C
AHA: American Heart Association; COR: class of recommendation;
ICD: implantable cardioverter defibrillator; LOE:
level of evidence; SCD: sudden cardiac death; WCD: wearable
cardioverter defibrillator.
Heart Rhythm Society, American College of Cardiology and the
American
Heart Association (ACC/AHA)
In 2014, the Heart Rhythm Society, ACC, and AHA issued a
consensus statement on the use of
ICD therapy in patients who are not included or not
well-represented in clinical trials.29 The
statement does not contain formal recommendations on WCD use,
but states: The wearable
cardioverter-defibrillator (WCD) may be an option as a bridge to
ICD for selected patients at
high risk of sudden cardiac death due to ventricular
arrhythmias, although the data are scant.
In 2014, ACC and AHA issued guidelines on the management of
non-ST-elevation acute
coronary syndrome (NSTE-ACS).30 These guidelines do not make
specific recommendations
regarding the use of WCDs, but do state the following:
Life-threatening ventricular arrhythmias that occur >48 hours
after NSTE-ACS are usually
associated with LV [left ventricular] dysfunction and signify
poor prognosis. RCTs
[randomized controlled trials] in patients with ACS [acute
coronary syndrome] have shown
consistent benefit of implantable cardioverter-defibrillator
therapy for survivors of VT
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[ventricular tachycardia] or VF [ventricular fibrillation]
arrest. For other at-risk patients,
especially those with significantly reduced LVEF [left
ventricular ejection fraction], candidacy
for primary prevention of sudden cardiac death with an
implantable cardioverter-defibrillator
should be readdressed 40 days after discharge. A life vest may
be considered in the
interim.
International Society for Heart and Lung Transplantation
In 2006, the International Society for Heart and Lung
Transplantation issued guidelines for the
care of cardiac transplant candidates that addressed use of ICDs
or WCDs.31 Recommendations
related to the use of WCDs include:
Class I recommendations: An implanted or wearable ICD should be
provided for Status 1B
patients [ie, dependent on intravenous medications or a
mechanical assist device] who are
discharged home given that the wait for transplantation remains
significant (Level of
Evidence: C).
Class IIa recommendations: It is reasonable to consider
placement of a defibrillator in
patients with Stage D failure who are candidates for
transplantation or LVAD [left ventricular
assist device] destination therapy (see subsequent
considerations for mechanical circulatory
support device [MCSD] referral: bridge or destination) (Level of
Evidence: C).
Medicare National Coverage
There is no national coverage determination (NCD). In the
absence of an NCD, coverage
decisions are left to the discretion of local Medicare
carriers.
Noridian Healthcare Solutions, LLC
Noridian Healthcare Solutions, LLC the contractor for
jurisdiction D has an LCD for Automatic
External Defibrillators (L13690) that includes coverage criteria
for beneficiaries at high risk for
sudden cardiac death (SCD) due to one of the conditions
described in the coverage guideline.33
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Regulatory Status
In December 2001, the Lifecor WCD 2000 system was approved by
the U.S. Food and Drug
Administration (FDA) through the premarket approval process 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.
FDA product code: MVK.
References
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29. Kusumoto FM, Calkins H, Boehmer J, et al. HRS/ACC/AHA expert
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125. PMID 24815500
30. Amsterdam EA, Wenger NK, Brindis RG, et al. 2014 AHA/ACC
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32. Epstein AE, DiMarco JP, et al. 2012 ACCF/AHA/HRS Focused
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PMID
23265327
33. Noridian Healthcare Solutions, LLC. Local coverage
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(L13690)
jurisdiction D; updated October 1, 2015. URL address:
https://med.noridianmedicare.com/documents/2230703/7218263/Automatic+External+Defibrillators/10f0b92d-0c55-
4b5d-aa15-b952b37c70ce Accessed June 2017.
34. BlueCross BlueShield Association. Medical Policy Reference
Manual. Wearable Cardioverter-Defibrillators. Policy No.
2.02.15,
2016.
Appendix
Selected components of the wearable
cardioverter-defibrillator1
https://med.noridianmedicare.com/documents/2230703/7218263/Automatic+External+Defibrillators/10f0b92d-0c55-4b5d-aa15-b952b37c70cehttps://med.noridianmedicare.com/documents/2230703/7218263/Automatic+External+Defibrillators/10f0b92d-0c55-4b5d-aa15-b952b37c70ce
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Page | 14 of 15
History
Date Comments 11/13/12 New Policy. Premera policy created to
include in the policy statement, information
about when coverage for the WCD will stop; and to maintain the
allowance of newly
diagnosed nonischemic cardiomyopathy (as explained in the Policy
Guidelines) as an
indication for the temporary use of the WCD. The Policy
Guidelines statement on
nonischemic cardiomyopathy was changed to investigational in the
October 2012
version of BCBSA policy 2.02.15. Therefore, Policy 2.02.15 is
deleted.
12/09/13 Replace policy. Policy updated with literature review.
References 6, 7, 13, 15 added. No
change to policy statement.
03/25/14 Replace policy. Policy statement unchanged. References
5, 6 added. ICD-9 and ICD-10
diagnosis codes removed; these are not utilized in
adjudication.
05/12/14 Interim review. Added primary prevention criteria found
in 7.01.44 to the Policy
Guidelines section.
12/01/14 Update Related Policies. Remove 2.02.10 as it was
archived.
03/31/15 Annual Review. Policy statements unchanged. References
8,17,23,26,27,28 added.
06/09/15 Interim review. Policy statement and policy guidelines
rewritten for clarification.
Reference 28 the Noridian LCD on WCD for jurisdiction D added;
others renumbered.
Policy statements revised as noted, intent is unchanged.
12/15/15 Update Related Policies. Remove 7.01.44 as it is
archived.
04/01/16 Update Related Policies Removed 2.02.505 as it was
archived.
08/01/16 Annual Review, approved July 12, 2016. Policy updated
with literature review through
March 22, 2016; references added. Policy statements
unchanged.
10/07/16 Minor formatting update. Updated hyperlink in reference
number 1.
07/01/17 Annual Review, approved June 22, 2017. Updated 2016 ACC
-AHA guidelines. Policy
moved into new format.
Disclaimer: This medical policy is a guide in evaluating the
medical necessity of a particular service or treatment. The
Company adopts policies after careful review of published
peer-reviewed scientific literature, national guidelines and
local standards of practice. Since medical technology is
constantly changing, the Company reserves the right to review
and update policies as appropriate. Member contracts differ in
their benefits. Always consult the member benefit
booklet or contact a member service representative to determine
coverage for a specific medical service or supply.
CPT codes, descriptions and materials are copyrighted by the
American Medical Association (AMA). 2017 Premera
All Rights Reserved.
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Page | 15 of 15
Scope: Medical policies are systematically developed guidelines
that serve as a resource for Company staff when
determining coverage for specific medical procedures, drugs or
devices. Coverage for medical services is subject to
the limits and conditions of the member benefit plan. Members
and their providers should consult the member
benefit booklet or contact a customer service representative to
determine whether there are any benefit limitations
applicable to this service or supply. This medical policy does
not apply to Medicare Advantage.
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037338 (07-2016)
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800-722-1471 (TTY: 800-842-5357) (Korean): . Premera Blue Cross
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