Download 2.02.506 Wearable Cardioverter-Defibrillators as a Bridge to

MEDICAL POLICY
POLICY
RELATED POLICIES
POLICY GUIDELINES
CODING
DESCRIPTION
SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
APPENDIX
HISTORY
Wearable Cardioverter-Defibrillators as a Bridge to
Implantable Cardioverter-Defibrillator Placement
Number
2.02.506
Effective Date
August 1, 2016
Revision Date(s) 10/07/16; 07/12/16; 04/01/16; 12/16/15; 07/14/15; 03/10/15;
05/12/14; 03/10/14; 12/09/13
Replaces
2.02.15
Policy
[TOP]
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 Policy Guidelines); 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 is 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 Policy
Guidelines); AND
 The ICD placement or an ICD replacement surgery, if appropriate, will be scheduled once the temporary
contraindication is treated or managed.
Use of a wearable cardioverter-defibrillator for the prevention of sudden cardiac death (SCD) is considered
investigational for all other indications, including immediately (i.e., less than 40 days) following an acute
myocardial infarction (AMI).
Related Policies
[TOP]
N/A
Policy Guidelines
[TOP]
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 is 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
1. Indications for ICD implantation can be broadly subdivided into two categories:
2. 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).
3. Secondary prevention, in patients who have experienced a life-threatening episode of VT, after
reversible causes have been excluded.
Primary Prevention criteria (32,33) 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
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 1 or more first-degree relatives younger than 50
years; left ventricular hypertrophy greater than 30 mm; 1 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
93292*
93745
K0606
K0607
K0608
K0609
CPT
Interrogation device evaluation (in person) with physician analysis, review and report, includes
connection, recording and disconnection per patient encounter; wearable defibrillator system
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
Automatic external defibrillator, with integrated electrocardiogram analysis, garment type
Replacement battery for automated external defibrillator, garment type only, each
Replacement garment for use with automated external defibrillator, each
Replacement electrodes for use with automated external defibrillator, garment type only, each
*Code 93292 cannot be reported with code 93745.
Description
[TOP]
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 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. (See Appendix for graphic.)
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, 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 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 counter shocks. See evidence review 7.01.44 for further
information on ICDs.
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 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.
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.
Scope
[TOP]
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 services representative to determine whether there are any benefit
limitations applicable to this service or supply. This policy does not apply to Medicare Advantage.
Benefit Application
[TOP]
N/A
Rationale
[TOP]
Populations
Individuals:
 With a temporary
contraindication to an
implantable cardioverter
defibrillator
Individuals:
 Who are in the immediate
post myocardial infarction
period
Interventions
Interventions of interest
are:
 Wearable cardioverter
defibrillator
Comparators
Comparators of interest
are:
 Usual care
Interventions of interest
are:
 Wearable cardioverter
defibrillator
Comparators of interest
are:
 Usual care
Individuals:
 Who are post coronary
artery bypass graft
surgery and at high risk
for lethal arrhythmias
Individuals:
 Who are awaiting heart
transplantation and at
high risk for lethal
arrhythmias
Individuals:
 With newly diagnosed
nonischemic
cardiomyopathy
Interventions of interest
are:
 Wearable cardioverter
defibrillator
Comparators of interest
are:
 Usual care
Interventions of interest
are:
 Wearable cardioverter
defibrillator
Comparators of interest
are:
Usual care
Interventions of interest
are:
 Wearable cardioverter
defibrillator
Comparators of interest
are:
 Usual care
Individuals:
 With peripartum
cardiomyopathy
Interventions of interest
are:
 Wearable cardioverter
defibrillator
Comparators of interest
are:
 Usual care
Outcomes
Relevant outcomes include:
 Overall survival
 Morbid events
 Functional outcomes
 Treatment-related morbidity
Relevant outcomes include:
 Overall survival
 Morbid events
 Functional outcomes
 Treatment-related morbidity
Relevant outcomes include:
 Overall survival
 Morbid events
 Functional outcomes
 Treatment-related morbidity
Relevant outcomes include:
 Overall survival
 Morbid events
 Functional outcomes
 Treatment-related morbidity
Relevant outcomes include:
 Overall survival
 Morbid events
 Functional outcomes
 Treatment-related morbidity
Relevant outcomes include:
 Overall survival
 Morbid events
 Functional outcomes
 Treatment-related morbidity
This evidence review was created in April 2003 and has been updated with periodic literature searches of the
MEDLINE database. The most recent literature update was conducted through March 22, 2016.
The available evidence on the wearable cardioverter-defibrillator (WCD) consists of case series describing
outcomes from patients using the device. There are no randomized controlled trials (RCTs) of WCD compared to
standard care or alternative treatments. Randomized controlled trials of patients undergoing permanent
implantable cardioverter-defibrillator (ICD) implantation can provide indirect evidence on the efficacy of the WCD
if the indications for a permanent ICD are similar to the potential indications for WCD and if the performance of
the WCD has been shown to approximate that of a permanent ICD.
FDA-labeled indications for the device are adult patients who are at risk for sudden cardiac arrest (SCA) and
either are not candidates for or refuse an ICD. (1) Some experts have suggested that the indications for a WCD
should be broadened to include other populations at high risk for SCA. (2) The potential indications include:
 Bridge to transplantation (i.e., the WEARIT population)
 Bridge to implantable device or clinical improvement (i.e., the BIROAD population)
o
Post bypass with ejection fraction less than 30%
o
Post bypass with ventricular arrhythmias or syncope within 48 hours of surgery
o
Post myocardial infarction with ejection fraction less than 30%
o
Post myocardial infarction with ventricular arrhythmias within 48 hours
 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
WCD Effectiveness Compared With ICD Effectiveness There are very few peer-reviewed studies have reported
on clinical outcomes of WCDs and none has evaluated the efficacy of WCD in reducing mortality compared with
alternatives. Despite the small amount of evidence, a 2010 TEC Assessment found concluded that the evidence
is sufficient to conclude the WCD can successfully terminate malignant ventricular arrhythmias. (3) Assessment
conclusions were based on several factors. 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 countershock can be delivered externally. The use of external defibrillators is extensive, ranging
from in-hospital use to public placement and use at home. Its novelty is in the way that the device is packaged
and utilized.
Second, there is a small amount of evidence that supports that the device successfully terminates arrhythmias.
Two uncontrolled studies were identified that directly tested the efficacy of the WCD. The first was a small case
series of 15 patients who were survivors of SCA and scheduled to receive an ICD. (4) During the procedure to
implant a permanent ICD, or to test a previously inserted ICD, patients wore the WCD while clinicians attempted
to induce ventricular arrhythmias. Of the 15 patients, 10 developed ventricular tachycardia (VT) or ventricular
fibrillation (VF). The WCD correctly detected the arrhythmia in 9 of 10 cases and successfully terminated the
arrhythmia in all 9 cases. In 2010, Chung et al. published an evaluation of WCD effectiveness for preventing
sudden death based on a postmarket release registry of 3569 patients who received a WCD. (5) Investigators
found an overall successful shock rate of 99% for VT or VF (79/80 cases of VT or VF among 59 patients). Fiftytwo percent of patients wore the device for more than 90% of the day. Eight patients died after successful
conversion of VT/VF.
In 2014, Tanawuttiwat et al. reported the results of a retrospective, uncontrolled evaluation of 97 patients who
received a WCD after their ICD was explanted due to device infection. (6) Subjects wore the device for a median
of 21 days; during the study period, 2 patients had 4 episodes of arrhythmia that were appropriately terminated by
the WCD, 1 patient experience 2 inappropriate treatments, and 3 patients experienced sudden death outside the
hospital while not wearing their WCD device.
The WEARIT/BIROAD study evaluated a prospective cohort of 289 patients at high risk for sudden cardiac death
(SCD) but who did not meet criteria for an ICD or who could not receive an ICD for several months.(7) Patients
were followed for a mean of 3.1 months. During this time, there were 8 documented episodes of arrhythmia
requiring shock in 6 separate patients. Six of the 8 episodes were successfully resuscitated by the WCD. By
group sequential analysis, the estimate of percent successful resuscitations was 69%. There was 99% confidence
that the true rate of success was greater than 25% and 90% confidence that the true rate was greater than 44%.
In the 2 cases of unsuccessful defibrillation, the authors reported that the WCD was placed incorrectly, with the
therapy electrodes reversed and not directed to the skin.
The WEARIT/BIROAD results underscore the difficulty in proper use and compliance with the device. Six patients
suffered SCA that was likely due to wearing the device improperly or not wearing the device at all. This implied
that a relatively high rate of nonadherence may be the main factor limiting the effectiveness of the WCD. Also,
there was a fairly high rate of dropout (22%) over the approximately 3 months of follow-up. In a study of 134
consecutive, uninsured patients with cardiomyopathy and a mean ejection fraction of 22.5% ± 7.3%, Mitrani et al.,
reported noncompliance with a WCD was even greater. The dropout rate was 35%. (8) The WCD was never used
by 8 patients and only 27% wore the device for more than 90% of the day. Patients who were followed for 72 ± 55
days wore the WCD for a mean of 14.1 ± 8.1 hours per day. Additionally, during follow-up, no arrhythmias or
shock were detected. In a prospective registry of 82 heart failure patients eligible for WCDs, Kao and colleagues
reported 13 patients (15.9%) did not wear the WCD due to refusal, discomfort or other/unknown reasons. (9)
These results suggest that the WCD is likely to be inferior to an ICD, due to suboptimal adherence and difficulty
with correct placement of the device. Therefore, these data corroborate the assumption that the WCD should not
be used as a replacement for an ICD but only considered in those situations in which the patient does not meet
criteria for a permanent ICD.
Another potential indication is for patients who are being evaluated for ICD placement. Clinical outcomes for
patients prescribed a WCD for a transient or undefined arrhythmia risk who were prospectively enrolled in the
WEARIT-II registry were published in abstract form in 2013, with 3-month results published in 2015.(10,11)
WEARIT-II enrolled 2000 patients with ischemic (n=805) or nonischemic cardiomyopathy (n=927) or
congenital/inherited heart disease (n=268) who had been prescribed a WCD for risk assessment. The median
wear time was 90 days, with a median daily use of 22.5 hours. The high compliance rate in this study may have
been related to greater compliance in patients who volunteered to participate in the registry. During the WCD trial
period there were 120 sustained ventricular tachyarrhythmias in 41 patients. Ninety of the events were withheld
from shock therapy by the patients and 30 required shock therapy. Appropriate shock was received by 22 (54%)
of the 41 patients, while 10 (0.5%) patients received inappropriate shock. Three patients died while wearing the
WCD, all from asystole. No patients died from VT or VF while wearing the WCD. At the end of the evaluation
period, 42% of patients received an ICD and 40% of patients were no longer considered to need an ICD, most
frequently because EF improved. Follow-up of clinical outcomes is continuing through 12 months.
Section Summary: WCD Effectiveness Compared With an ICD Effectiveness
No studies have directly compared the performance of a WCD to a permanent ICD. One small study in an
electrophysiology lab demonstrated that the WCD can correctly identify and terminate most induced ventricular
arrhythmias. A cohort study of WCD use estimated that the percent of successful resuscitations was
approximately 70%. In that study, there was a high rate of nonadherence and dropouts, and failures to
successfully resuscitate were largely attributed to incorrect use of the device and/or nonadherence. A more recent
registry study reported high compliance rate when used as a trial for ICD implantation, though these results may
be biased by self-selection. This evidence indicates that the WCD can successfully detect and terminate
arrhythmias in at least some patients but that overall performance in clinical practice is likely to be inferior to a
permanent ICD
WCD as Bridge to ICD, Heart Transplantation, or Recovery
The WCD can be used in a variety of situations as a bridge to ICD, heart transplantation, or recovery. The specific
indications addressed in this review are:
 Temporary contraindications to implantable cardioverter-defibrillator
 Immediate post-MI period
 High-risk patients post-CABG [coronary artery bypass graft] surgery
 High-risk patients awaiting heart transplantation
 Newly diagnosed non-ischemic cardiomyopathy
 Peripartum cardiomyopathy
Temporary Contraindications to Implantable Cardioverter-Defibrillator (ICD)
Contraindications to an ICD are few. According to the American College of Cardiology/American Heart
Association/ (ACC/AHA) guidelines on ICD use, the device is contraindicated in patients with terminal illness, with
drug-refractory class IV congestive heart failure, 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. (12) It is not
known how many patients refuse an ICD after it has been recommended for them.
A few patients meet established criteria for an ICD (see Policy Guidelines) but have a transient (i.e., short-term)
contraindication for an implantable device. The most common contraindication is a systemic infectious process
that precludes ICD insertion or when an ICD is removed due to infection and the reinsertion is delayed until the
infection is resolved. The WCD may be beneficial, if the device is able to successfully detect and abort ventricular
arrhythmias in this population. The study by Tanawuttiwat et al. referenced above provides some direct evidence
that the WCD can be successful, but its successful use may be limited by nonadherence, given that 3 of the 97
patients included in the study died outside of the hospital while not wearing the WCD.
The WCD avoids potential complications associated with ICD implantation, but complication rates with current
techniques for ICD placement are low. In 1 large trial of ICD versus antiarrhythmic drug therapy, (12)
complications of ICD implantation in 507 patients included hematomas in 13 (2.6%), bleeding requiring
transfusion or reoperation in 6 (1.2%), infection in 10 (2.0%), pneumothorax in 8 (1.6%), and cardiac perforation in
1 (0.2%).(13) Early mortality (within 30 days of procedure) was not higher for the ICD group (2.4%), compared to
the medication group (3.5%).
Immediate Post-MI Period
The evidence on the use of a WCD as a bridge to permanent ICD placement was reviewed in a 2010 TEC
Assessment. (3) The most common of these indications is for patients who are in the immediate post-myocardial
infarction (MI) period. For these patients, indications for a permanent ICD cannot be reliably assessed
immediately post-MI, since it is not possible to determine the final ejection fraction until at least 30 days after the
event. Since the first 30 days following an acute MI represent a high-risk period for lethal ventricular arrhythmias,
there is a potential to improve mortality by using other treatments to prevent SCA.
Despite the rationale for this potential indication, the TEC Assessment concluded that the available evidence does
not support the argument that any cardioverter-defibrillator improves mortality in patients in the immediate post-MI
period. One post-hoc analysis of a randomized, controlled trial and two prospective randomized controlled trials
were reviewed that led to this conclusion.
Secondary analysis of data from the MADIT-II trial evaluated whether an ICD improves mortality in the early postMI period. (14) MADIT-II randomly assigned 1,159 patients with prior MI and an ejection fraction of less than 30%
to an ICD or control and showed an overall mortality benefit for patients treated with an ICD. The secondary
analysis examined the benefit of ICD according to length of time from the original MI and showed that the benefit
of ICD was dependent on the length of time since the original MI. Within the first 18 months post-MI, there was no
benefit found for ICD implantation (hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.51-1.81, p=0.92). In
contrast, there was a significant mortality benefit when the length of time since MI was greater than 18 months
(HR: 0.55; 95% CI: 0.39-0.78, p=0.001).
Two randomized controlled trials (RCTs) were specifically designed to address the question of early ICD use
post-MI. The DINAMIT study (15) evaluated the utility of an automatic ICD (AICD) for this patient population. This
trial randomly assigned 342 patients with an acute MI and an ejection fraction of 35% or less. The primary
outcome was death from any cause, and a predefined secondary outcome was death from an arrhythmia. After a
mean follow-up of 30 months, there was no difference in overall survival for the ICD group compared to control
(HR: 1.08; 95% CI: 0.76-1.55, p=0.66). There was a significant difference for the ICD group in the secondary
outcome of death from arrhythmia (HR: 0.42; 95% CI: 0.22-0.83, p=0.009). The decrease in deaths from
arrhythmias for the ICD group was offset by a corresponding increase in deaths due to nonarrhythmic, cardiac
causes. The authors suggest that the discrepancy in these outcomes may arise from the fact that patients in
whom the ICD successfully aborted an arrhythmia may have eventually died from other cardiac causes, such as
progressive heart failure.
The IRIS trial (16) was similar in design to the DINAMIT trial. This study included 998 patients who were 5 to 31
days post-MI and had at least 1 other high-risk factor, either nonsustained ventricular tachycardia or a resting
pulse greater than 90. Patients were followed for a mean of 37 months. Results of the IRIS trial were similar to
DINAMIT, with no difference in overall mortality between the ICD and control groups (26.1% vs. 25,
respectively.8%, p=0.76). The ICD group had a decreased rate of SCD (6.1% vs. 13.2%, respectively, p=0.049),
which was offset by a higher rate of nonsudden cardiac death (15.3% vs. 8.6%, respectively, p=0.001). This study
also reported noncardiac death, which was similar for the ICD and control groups (4.7% vs. 4.0%, respectively,
p=0.51).
In 2013, Epstein et al. reported on registry data from 8,453 post MI patients who received WCDs for risk of
sudden cardiac arrest while awaiting placement of an ICD. (17) The WCD was worn a median length of 57 days
(mean length of 69 ± 61 days) with a median daily use of 21.8 hours, Appropriate shocks were delivered 309
times in 133 patients (1.6%), 91% of which were successful in resuscitating patients from ventricular arrhythmias.
For shocked patients, 62% were revascularized post-MI and the left-ventricular ejection fraction (LVEF) averaged
23.8 ± 8.8%. While 1.4% of this registry population was successfully treated with WCDs, interpretation of registry
data is limited. It is not possible to determine whether outcomes were improved without a control group, and the
registry contained limited patient and medical information further limiting interpretation of results.
In 2014, Uyei et al. reported results of a systematic review conducted with the goal of evaluating the effectiveness
of WCD use in several clinical situations, including for individuals early (≤40 days) post-MI with an LVEF less than
or equal to 35%.(18) The authors identified 36 articles and conference abstracts, most of which (N=28; 78%) were
conference abstracts. Four studies (Chung et al. [2010], (5) Epstein et al. [2013] (17), and 2 conference abstracts)
assessed the effectiveness of WCD use in post-MI patients. Outcomes reported were heterogeneous. For 2
studies that reported VF/VT-related mortality, on average 0.52 percent (2/384) of the study population died of VF
or VT over 58.3 mean days of WCD use. For 2 studies that reported on VT/VF incidence, on average 2.8 percent
(11/384) of WCD users experienced a VT and/or VF event over the course 58.3 (range, 3–146) mean days of WD
use. Among those who experienced a VT/VF event, on average 82 percent (9/11) experienced successful
termination of one or more arrhythmic events.
Patients Post CABG Surgery Who Are at High Risk for Lethal Arrhythmias One RCT (CABG PATCH) evaluated
early ICD placement in high-risk post CABG patients, selected with a low LVEF and abnormalities on signalaveraged electrocardiogram.(19) The trial followed patients for a mean of 32 months and reported on overall
mortality. Trial results indicated no difference in overall mortality between the ICD and the control groups
(HR=1.07; 95% CI, 0.81 to 1.42). No other mortality outcomes were reported. There was a higher rate of
infections in the ICD group, both deep sternal infections (2.7% vs 0.4%, respectively, p<0.05) and superficial
wound infections (12.3% vs 5.9%, respectively, p<0.05). The cumulative incidence of inappropriate shocks was
50% at 1 year and 57% at 2 years.
Zishiri et al. performed a retrospective study that used registry data to compare outcomes with or without WCD
use in patients with LVEF <35% after CABG surgery or percutaneous coronary intervention (PCI). (20) A national
registry maintained by the manufacturer was used to identify 809 patients treated with a WCD post-discharge,
and a separate registry from the Cleveland Clinic was used to identify 4,149 patients discharged without a
defibrillator. At baseline, there were significant differences between groups on age, gender, LVEF and time period
of treatment. Of the 809 patients treated with WCD, 1.3% had documented appropriate defibrillation treatment for
an arrhythmia. Post-CABG, 90-day mortality was 3% in patients with WCDs versus 7% without WCDs (p=0.03).
Post-PCI, 90-day mortality was 2% in patients with WCDs versus 10% without WCDs (p<0.0001). Adjusted longterm mortality risks, after a mean follow-up of 3.2 years, was also decreased in the WCD group (HR: 0.74, 95%
CI: 0.57-0.97, p=0.027). These differences in mortality persisted after propensity matching. However,
interpretation of this registry data is limited since patients treated with a WCD differed from patients who were not
treated, and these differences may not have been completely eliminated through propensity matching.
In the 2014 Uyei et al. systematic review described above, 3 studies (Chung et al. [2010] (5). Epstein et al. [2013]
(17), and 1 conference abstract) were identified that reported outcomes for WCDs after coronary revascularization
for patients with LVEF less than or equal to 35%.(17) Reported outcomes were heterogeneous across studies. In
one study that reported on VT/VF-related mortality, 0.41% (1/243) of the study population died of VT or VF over
the course of 59.8 days (mean or median not specified). Of those who experienced a VT/VF event, 7% of patients
died over the course of “approximately 2 months” of WCD use. In another study, 50% of those with VT/VF events
died over the course of 59.8 days.
Patients Awaiting Heart Transplantation Who Are High Risk for Lethal Arrhythmias
Many patients awaiting heart transplantation are at high risk for lethal arrhythmias. A WCD can be used to reduce
risks associated with ICD implantation or in situations where an ICD is contraindicated. In 2015, Opreanu et al
analyzed a manufacturer’s database to identify patients prescribed a WCD as a bridge to heart transplantation.
(21) The registry included 121 patients, 12% with New York Heart Association (NYHA) functional class II heart
failure, 32% with NYHA class III heart failure, 34% with NYHA class IV heart failure, and 21% unknown. Of the
121 patients, 73% were being evaluated for heart transplantation or were on a heart transplantation waiting list,
and 27% were awaiting retransplantation following rejection of a prior heart transplantation. Patients wore the
WCD for a median of 20 hours per day for a median of 39 days. Seven (6%) patients received appropriate WCD
shocks during this period and survived. Two patients received inappropriate shocks. Thirteen (11%) patients
ended WCD use after heart transplantation, 42% ended WCD use after ICD implantation, and 15% ended WCD
use after EF improved. There were 11 (9%) deaths; 9 of these patients were not wearing a WCD at the time of
death. The 2 patients who died while wearing the WCD had asystole.
Patients awaiting transplantation have also been included in studies with mixed populations. The
WEARIT/BIROAD study (discussed previously) assessed a prospective cohort that included patients awaiting
transplant, but it also included other high-risk patients and did not report separately on the population of patients
awaiting transplant.(7) Rao et al published a case series of 162 patients with congenital structural heart disease
or inherited arrhythmias treated with WCD. (22) Approximately one-third of these patients had a permanent ICD,
which was explanted due to infection or malfunction. The remaining patients used the WCD either as a bridge to
heart transplantation, during an ongoing cardiac evaluation, or in the setting of surgical or invasive procedures
that increased the risk of arrhythmias. Four patients died during a mean duration of WCD treatment of
approximately 1 month, but none was related to cardiac causes. Two patients received a total of 3 appropriate
shocks for VT or VF, and 4 patients received a total of 7 inappropriate shocks. The results of this series
suggested that the WCD can be worn safely and can detect arrhythmias in this population, but the rate of
inappropriate shocks was relatively high.
Newly Diagnosed Nonischemic Cardiomyopathy
In patients with newly diagnosed nonischemic cardiomyopathy, final EF is uncertain because some patients show
an improvement in EF over time. A post hoc analysis of the DEFINITE trial, which evaluated use of an ICD in
nonischemic dilated cardiomyopathy, examined the benefit of ICD use by time since diagnosis. (23) This trial
excluded patients with a clinical picture consistent with a reversible cause of cardiomyopathy and thus may differ
from the population considered for a WCD. For the overall DEFINITE trial, there was a 35% reduction in overall
mortality, but this difference was not statistically significant. In reanalysis, patients were divided into recent
diagnosis of cardiomyopathy (<3 months) and remote diagnosis (>9 months). The difference in survival was of
borderline significance for the ICD group compared with controls, both for the recently diagnosed subgroup
(HR=0.38; 95% CI, 0.14 to 1.00; p=0.05) and the remotely diagnosed subgroup (HR=0.43; 95% CI, 0.22 to 0.99;
p=0.046).
The WEARIT-II registry included 927 patients with nonischemic cardiomyopathy who were prescribed a WCD.(11)
At the end of the evaluation period, an ICD was implanted in 36% of patients. In 42% of patients, EF improved
during the trial period, negating the need for an ICD. Another 22% of patients did not receive an ICD for other
reasons.
Another potential indication for the WCD is in in situations where the cardiomyopathy is reversible, but temporary
protection against arrhythmias is needed. For example, this may occur in patients with alcoholic cardiomyopathy
who abstain from alcohol. Salehi et al identified 127 patients from a manufacturer’s database with nonischemic
cardiomyopathy possibly related to alcohol use. (24) Mean EF was 19.9% on presentation. Patients wore the
WCD for a median of 51 days and a median of 18.0 hours a day. During this period, 7 patients received 9
appropriate shocks and 13 patients received 18 inappropriate shocks. At the end of WCD use, 33% of patients
had improved EF and did not require ICD placement; 24% received an ICD. Four deaths occurred during this
period, 1 while wearing the WCD (due to ventricular asystole).
Kao et al reported on a prospective registry of 82 heart failure patients who were eligible for a WCD.(9) Dilated
cardiomyopathy and EF less than 40% were diagnosed in 81 (98.8%) of patients and cardiac transplantation was
indicated for 12 patients. During the study, the WCD was worn for 75 (58) days, during which time no SCDs or
deaths occurred. Improvement was reported in 41.5% of patients who no longer met criteria for defibrillator use.
ICD placement was reported in 34.1%.of patients, and 1 patient received a heart transplant. As noted above, 13
patients (16%) did not wear the WCD (due to refusal, discomfort, other/unknown reasons)
The 2014 Uyei et al systematic review previously described identified 4 studies (Saltzberg et al, (25) Chung et al,
(5) 2 conference abstracts) that assessed WCD use in newly diagnosed nonischemic cardiomyopathy. (18) In the
3 studies that reported VT/VF incidence, an average 0.57% (5/871) subjects experienced VT and/or VF over a
mean duration of 52.6 days. Among those who did experience a VT or VF event, an average of 80% experienced
successful event termination.
Peripartum Cardiomyopathy
One study of WCD use in peripartum cardiomyopathy was published in 2012. (25) This study included 107
women with peripartum cardiomyopathy treated with a WCD device from 2003 through 2009. Patients were
identified from a registry of WCD use maintained by a device manufacturer. WCD were worn for an average of
124 days. During this time, no shocks were delivered, either appropriate shocks or inappropriate shocks. There
were no patient deaths during the time of WCD treatment. Following discontinuation of the WCD, there were 3
deaths over a mean follow-up of 3.0 (1.2) years. In a matched group of 159 women with nonischemic
cardiomyopathy who wore the WCD for 96 (83) days, there were 2 appropriate shocks and 11 deaths.
In a smaller study reported in 2014, Duncker et al reported outcomes for 12 prospectively enrolled women with
peripartum cardiomyopathy treated at a single center and followed for a median of 12 months. (26) A WCD was
recommended for 9 patients with LVEF of 35% or less and 7 of them consented to wear the WCD. For these 7
patients, the median WCD wearing time was 81 days (mean, 133 days). In 3 patients, 4 episodes of VF were
detected that led to delivery of a shock, which successfully terminated the arrhythmia in all cases. No
inappropriate shocks were delivered. Among the 5 patients without WCD, no episodes of syncope or ventricular
arrhythmia or deaths occurred.
Section Summary: WCD as Bridge to ICD, Heart Transplant, or Recovery
For patients with indications for an ICD but temporary contraindications, the use of a WCD for a temporary period
of time is likely to improve outcomes. These patients are expected to benefit from an ICD, and the use of a WCD
is a reasonable alternative as there are no other options for automatic detection and termination of ventricular
arrhythmias.
Two RCTs of implantable cardioverter-defibrillator use in the early post-acute MI period concluded that mortality
was not improved compared to usual care. In both these trials, sudden cardiac death was reduced in the ICD
group, but non-sudden cardiac death was increased, resulting in no difference in overall mortality. One trial of
high-risk post-CABG patients also reported no benefit from implantation of a permanent ICD. Since a permanent
ICD does not appear to be beneficial in these situations, a WCD would also not be beneficial for these patient
populations.
For other indications, evidence is lacking concerning the impact of a WCD on outcomes. Case series for these
conditions are not sufficient to determine whether a WCD improves outcomes compared to usual care.
External Automatic Cardiac Defibrillators
Home use of an automatic external cardiac defibrillator is another potential alternative to either an ICD or a
wearable defibrillator. However, there are no clinical trials that establish the efficacy of automatic external
defibrillators for high-risk patients. Bardy et al. (24) randomly assigned 7,001 patients with anterior wall MI, who
were not candidates for ICD implantation, to home external defibrillator or usual care. After a median follow-up of
37.3 months, there was no difference in mortality between groups (HR 0.97, 95% CI: 0.81-1.17). Therefore, home
external defibrillators may not be a good alternative to ICD or WCD in high-risk patients.
Ongoing Trials 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
Ongoing
a
NCT01326624
Study of the Wearable Defibrillator In Heart-Failure Patients
25
Ambulatory Post-Syncope Arrhythmia Protection Feasibility
Study Protocol
Prevention of Sudden Death After Myocardial Infarction
Using a LifeVest Wearable Cardioverter-defibrillator
80
Post-market Release Registry of Wearable Defibrillator Use
in Patients With Ventricular Dysfunction Following CABG
Surgery
Hospital Wearable Defibrillator Inpatient Study
69
Oct 2014
(terminated)
59
Jul 2015
(completed)
NCT02188147
a
NCT01446965
a
Unpublished
a
NCT01448005
NCT02122549
a
Planned
Enrollment
1900
Completion Date
Mar 2016
(ongoing)
Mar 2016
(ongoing)
Dec 2017
NCT: national clinical trial.
a
Denotes industry-sponsored or cosponsored trial.
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, 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 treatment–related
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.
Clinical Input Received From Physician Specialty Societies and Academic Medical
Centers
While the various physician specialty societies and academic medical centers may collaborate with and make
recommendations during this process, through the provision of appropriate reviewers, input received does not
represent an endorsement or position statement by the physician specialty societies or academic medical centers,
unless otherwise noted.
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)
Guidelines from the major cardiology specialty societies do not make specific recommendations for the use of
WCD. For example, 2006 American College of Cardiology (ACC) and American Heart Association (AHA)
guidelines on the treatment of patients with ventricular arrhythmias (28) includes the following statement on WCD
but does not include a formal recommendation: “The wearable automatic defibrillator has been approved in the
United States by the FDA [Food and Drug Administration] for cardiac patients with a transient high risk for VF
[ventricular fibrillation] such as those awaiting cardiac transplantation, those at very high risk after a recent MI
[myocardial infarction] or an invasive cardiac procedure, or those requiring temporary removal of an infected
implanted defibrillator for antibiotic therapy.” 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 cardioverterdefibrillator therapy for survivors of VT [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).”
U.S. Preventive Services Task Force Recommendations
Not applicable
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)
References
[TOP]
1. U.S. Food and Drug Administration. Summary of Safety and Effectiveness Data, P010030, Lifecor, Inc,
WCD® 2000 System. http://www.accessdata.fda.gov/cdrh_docs/pdf/p010030b.pdf Accessed October
2016.
2. Beauregard LA. Personal security: Clinical applications of the wearable defibrillator. Pacing Clin
Electrophysiol. Jan 2004;27(1):1-3. PMID 14720147
3. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Wearable cardioverterdefibrillator as a bridge to implantable cardioverter-defibrillator treatment. TEC Assessments.
2010;Volume 25, Tab 2.
4. Auricchio A, Klein H, Geller CJ, et al. Clinical efficacy of the wearable cardioverter-defibrillator in acutely
terminating episodes of ventricular fibrillation. Am J Cardiol. May 15 1998;81(10):1253-1256. PMID
9604964
5. Chung MK, Szymkiewicz SJ, Shao M, et al. Aggregate national experience with the wearable
cardioverter-defibrillator: event rates, compliance, and survival. J Am Coll Cardiol. Jul 13 2010;56(3):194203. PMID 20620738
6. Tanawuttiwat T, Garisto JD, Salow A, et al. Protection from outpatient sudden cardiac death following
ICD removal using a wearable cardioverter defibrillator. Pacing Clin Electrophysiol. May 2014;37(5):562568. PMID 24762055
7. Feldman AM, Klein H, Tchou P, et al. Use of a wearable defibrillator in terminating tachyarrhythmias in
patients at high risk for sudden death: results of the WEARIT/BIROAD. Pacing Clin Electrophysiol. Jan
2004;27(1):4-9. PMID 14720148
8. Mitrani RD, McArdle A, Slane M, et al. Wearable defibrillators in uninsured patients with newly diagnosed
cardiomyopathy or recent revascularization in a community medical center. Am Heart J. Mar
2013;165(3):386-392. PMID 23453108
9. Kao AC, Krause SW, Handa R, et al. Wearable defibrillator use in heart failure (WIF): results of a
prospective registry. BMC Cardiovasc Disord. 2012;12:123. PMID 23234574
10. Goldenberg I KH, Zareba W et al. Eighteen Month Results From The Prospective Registry And Followup Of Patients Using The Lifevest Wearable Defibrillator (WEARIT-II Registry) - LB02-02. Heart Rhythm
2013 - 34th Annual Scientific Sessions; May 10, 2013.
11. Kutyifa V, Moss AJ, Klein H, et al. Use of the wearable cardioverter defibrillator in high-risk cardiac
patients: data from the Prospective Registry of Patients Using the Wearable Cardioverter Defibrillator
(WEARIT-II Registry). Circulation. Oct 27 2015;132(17):1613-1619. PMID 26316618
12. Gregoratos G, Cheitlin MD, Conill A, et al. ACC/AHA guidelines for implantation of cardiac pacemakers
and antiarrhythmia devices: a report of the American College of Cardiology/American Heart Association
Task Force on Practice Guidelines (Committee on Pacemaker Implantation). J Am Coll Cardiol. Apr
1998;31(5):1175-1209. PMID 9562026
13. Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmicdrug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias
N Engl J Med. Nov 27 1997;337(22):1576-1583. PMID 9411221
14. Wilber DJ, Zareba W, Hall WJ, et al. Time dependence of mortality risk and defibrillator benefit after
myocardial infarction. Circulation. Mar 9 2004;109(9):1082-1084. PMID 14993128
15. Hohnloser SH, Kuck KH, Dorian P, et al. Prophylactic use of an implantable cardioverter-defibrillator after
acute myocardial infarction. N Engl J Med. Dec 9 2004;351(24):2481-2488. PMID 15590950
16. Steinbeck G, Andresen D, Seidl K, et al. Defibrillator implantation early after myocardial infarction. N
Engl J Med. Oct 8 2009;361(15):1427-1436. PMID 19812399
17. Epstein AE, Abraham WT, Bianco NR, et al. Wearable cardioverter-defibrillator use in patients perceived
to be at high risk early post-myocardial infarction. J Am Coll Cardiol. Nov 19 2013;62(21):2000-2007.
PMID 23916930
18. Uyei J, Braithwaite RS. Effectiveness of wearable defibrillators: systematic review and quality of
evidence. Int J Technol Assess Health Care. Apr 2014;30(2):194-202. PMID 24893969
19. Bigger JT, Jr. Prophylactic use of implanted cardiac defibrillators in patients at high risk for ventricular
arrhythmias after coronary-artery bypass graft surgery. Coronary Artery Bypass Graft (CABG) Patch Trial
Investigators. N Engl J Med. Nov 27 1997;337(22):1569-1575. PMID 9371853
20. Zishiri ET, Williams S, Cronin EM, 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. Feb 2013;6(1):117-128. PMID 23275233
21. Opreanu M, Wan C, Singh V, et al. Wearable cardioverter-defibrillator as a bridge to cardiac
transplantation: A national database analysis. J Heart Lung Transplant. Oct 2015;34(10):1305-1309.
PMID 26094085
22. Rao M, Goldenberg I, Moss AJ, et al. Wearable defibrillator in congenital structural heart disease and
inherited arrhythmias. Am J Cardiol. Dec 1 2011;108(11):1632-1638. PMID 21890075
23. Kadish A, Schaechter A, Subacius H, et al. Patients with recently diagnosed nonischemic
cardiomyopathy benefit from implantable cardioverter-defibrillators. J Am Coll Cardiol. Jun 20
2006;47(12):2477-2482. PMID 16781376
24. Salehi N, Nasiri M, Bianco NR, et al. The Wearable Cardioverter Defibrillator in Nonischemic
Cardiomyopathy: A US National Database Analysis. Can J Cardiol. Jan 14 2016. PMID 26975224
25. Saltzberg MT, Szymkiewicz S, Bianco NR. Characteristics and outcomes of peripartum versus
nonperipartum cardiomyopathy in women using a wearable cardiac defibrillator. J Card Fail. Jan
2012;18(1):21-27. PMID 22196837
26. Duncker D, Haghikia A, Konig T, et al. Risk for ventricular fibrillation in peripartum cardiomyopathy with
severely reduced left ventricular function-value of the wearable cardioverter/defibrillator. Eur J Heart Fail.
Dec 2014;16(12):1331-1336. PMID 25371320
27. Bardy GH, Lee KL, Mark DB, et al. Home use of automated external defibrillators for sudden cardiac
arrest. N Engl J Med. Apr 24 2008;358(17):1793-1804. PMID 18381485
28. Zipes DP, Camm AJ, Borggrefe M, et al. ACC/AHA/ESC 2006 guidelines for management of patients
with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American
College of Cardiology/American Heart Association Task Force and the European Society of Cardiology
Committee for Practice Guidelines (Writing Committee to Develop Guidelines for Management of
Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death). J Am Coll Cardiol.
Sep 5 2006;48(5):e247-346. PMID 16949478
29. Kusumoto FM, Calkins H, Boehmer J, et al. HRS/ACC/AHA expert consensus statement on the use of
implantable cardioverter-defibrillator therapy in patients who are not included or not well represented in
clinical trials. Circulation. Jul 1 2014;130(1):94-125. PMID 24815500
30. Amsterdam EA, Wenger NK, Brindis RG, et al. 2014 AHA/ACC guideline for the management of patients
with non-ST-elevation acute coronary syndromes: a report of the American College of
Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. Dec 23
2014;130(25):e344-426. PMID 25249585
31. Gronda E, Bourge RC, Costanzo MR, et al. Heart rhythm considerations in heart transplant candidates
and considerations for ventricular assist devices: International Society for Heart and Lung Transplantation
guidelines for the care of cardiac transplant candidates--2006. J Heart Lung Transplant. Sep
2006;25(9):1043-1056. PMID 16962465
32. Epstein AE, DiMarco JP, et al. 2012 ACCF/AHA/HRS Focused Update Incorporated Into the
ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of
the American College of Cardiology Foundation/American Heart Association Task Force on Practice
Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2013;61(3):e6-e75. PMID 23265327
33. Noridian Healthcare Solutions, LLC. Local coverage determination (LCD) for automatic external
defibrillators (L13690) jurisdiction D; updated October 1, 2015. URL address:
https://med.noridianmedicare.com/documents/2230715/2240923/Automatic+External+Defibrillators.pdf/7
e9beb10-31bc-4078-875b-e4211dc1f68f Accessed June 2016.
34. BlueCross BlueShield Association. Medical Policy Reference Manual. Wearable CardioverterDefibrillators. Policy No. 2.02.15, 2016.
Appendix
[TOP]
Selected components of the wearable cardioverter-defibrillator (from FDA website)
History
[TOP]
Date
11/13/12
12/09/13
03/25/14
Reason
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.
Replace policy. Policy updated with literature review. References 6, 7, 13, 15 added. No change to
policy statement.
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
12/01/14
03/31/15
06/09/15
12/15/15
04/01/16
07/12/16
10/07/16
Interim review. Added primary prevention criteria found in 7.01.44 to the Policy Guidelines section.
Update Related Policies. Remove 2.02.10 as it was archived.
Annual Review. Policy statements unchanged. References 8,17,23,26,27,28 added.
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.
Update Related Policies. Remove 7.01.44 as it is archived.
Update Related Policies Removed 2.02.505 as it was archived.
Annual Review. Policy updated with literature review through March 22, 2016; references added.
Policy statements unchanged.
Minor formatting update. Updated hyperlink in reference number 1.
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).
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ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል። ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue
Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል። በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ።
የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ
ይገባዎት ይሆናል። ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት
አለዎት።በስልክ ቁጥር 800-722-1471 (TTY: 800-842-5357) ይደውሉ።
‫( العربية‬Arabic):
‫ قد يحوي ھذا اإلشعار معلومات مھمة بخصوص طلبك أو‬.‫يحوي ھذا اإلشعار معلومات ھامة‬
‫ قد تكون ھناك تواريخ مھمة‬.Premera Blue Cross ‫التغطية التي تريد الحصول عليھا من خالل‬
‫ وقد تحتاج التخاذ إجراء في تواريخ معينة للحفاظ على تغطيتك الصحية أو للمساعدة‬.‫في ھذا اإلشعار‬
‫ اتصل‬.‫ يحق لك الحصول على ھذه المعلومات والمساعدة بلغتك دون تكبد أية تكلفة‬.‫في دفع التكاليف‬
800-722-1471 (TTY: 800-842-5357)‫بـ‬
中文 (Chinese):
本通知有重要的訊息。本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息。本通知內可能有重要日期。您可能需要在截止日期
之前採取行動，以保留您的健康保險或者費用補貼。您有權利免費以您的母
語得到本訊息和幫助。請撥電話 800-722-1471 (TTY: 800-842-5357)。
037338 (07-2016)
Oromoo (Cushite):
Beeksisni kun odeeffannoo barbaachisaa qaba. Beeksisti kun sagantaa
yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee
odeeffannoo barbaachisaa qabaachuu danda’a. Guyyaawwan murteessaa
ta’an beeksisa kana keessatti ilaalaa. Tarii kaffaltiidhaan deeggaramuuf
yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan
jiraachuu danda’a. Kaffaltii irraa bilisa haala ta’een afaan keessaniin
odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu.
Lakkoofsa bilbilaa 800-722-1471 (TTY: 800-842-5357) tii bilbilaa.
Français (French):
Cet avis a d'importantes informations. Cet avis peut avoir d'importantes
informations sur votre demande ou la couverture par l'intermédiaire de
Premera Blue Cross. Le présent avis peut contenir des dates clés. Vous
devrez peut-être prendre des mesures par certains délais pour maintenir
votre couverture de santé ou d'aide avec les coûts. Vous avez le droit
d'obtenir cette information et de l’aide dans votre langue à aucun coût.
Appelez le 800-722-1471 (TTY: 800-842-5357).
Kreyòl ayisyen (Creole):
Avi sila a gen Enfòmasyon Enpòtan ladann. Avi sila a kapab genyen
enfòmasyon enpòtan konsènan aplikasyon w lan oswa konsènan kouvèti
asirans lan atravè Premera Blue Cross. Kapab genyen dat ki enpòtan nan
avi sila a. Ou ka gen pou pran kèk aksyon avan sèten dat limit pou ka
kenbe kouvèti asirans sante w la oswa pou yo ka ede w avèk depans yo.
Se dwa w pou resevwa enfòmasyon sa a ak asistans nan lang ou pale a,
san ou pa gen pou peye pou sa. Rele nan 800-722-1471
(TTY: 800-842-5357).
Deutsche (German):
Diese Benachrichtigung enthält wichtige Informationen. Diese
Benachrichtigung enthält unter Umständen wichtige Informationen
bezüglich Ihres Antrags auf Krankenversicherungsschutz durch Premera
Blue Cross. Suchen Sie nach eventuellen wichtigen Terminen in dieser
Benachrichtigung. Sie könnten bis zu bestimmten Stichtagen handeln
müssen, um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten
zu behalten. Sie haben das Recht, kostenlose Hilfe und Informationen in
Ihrer Sprache zu erhalten. Rufen Sie an unter 800-722-1471
(TTY: 800-842-5357).
Hmoob (Hmong):
Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb. Tej zaum
tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv
thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue
Cross. Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv
no. Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub
dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj
yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob
ntawd. Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau
ua koj hom lus pub dawb rau koj. Hu rau 800-722-1471
(TTY: 800-842-5357).
Iloko (Ilocano):
Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion. Daytoy a
pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion
maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue
Cross. Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar.
Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti
partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti
salun-atyo wenno tulong kadagiti gastos. Adda karbenganyo a mangala iti
daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti
bayadanyo. Tumawag iti numero nga 800-722-1471 (TTY: 800-842-5357).
Italiano (Italian):
Questo avviso contiene informazioni importanti. Questo avviso può contenere
informazioni importanti sulla tua domanda o copertura attraverso Premera
Blue Cross. Potrebbero esserci date chiave in questo avviso. Potrebbe
essere necessario un tuo intervento entro una scadenza determinata per
consentirti di mantenere la tua copertura o sovvenzione. Hai il diritto di
ottenere queste informazioni e assistenza nella tua lingua gratuitamente.
Chiama 800-722-1471 (TTY: 800-842-5357).
日本語 (Japanese):
この通知には重要な情報が含まれています。この通知には、Premera Blue
Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
ります。この通知に記載されている可能性がある重要な日付をご確認くだ
さい。健康保険や有料サポートを維持するには、特定の期日までに行動を
取らなければならない場合があります。ご希望の言語による情報とサポー
トが無料で提供されます。800-722-1471 (TTY: 800-842-5357)までお電話
ください。
Română (Romanian):
Prezenta notificare conține informații importante. Această notificare
poate conține informații importante privind cererea sau acoperirea asigurării
dumneavoastre de sănătate prin Premera Blue Cross. Pot exista date cheie
în această notificare. Este posibil să fie nevoie să acționați până la anumite
termene limită pentru a vă menține acoperirea asigurării de sănătate sau
asistența privitoare la costuri. Aveți dreptul de a obține gratuit aceste
informații și ajutor în limba dumneavoastră. Sunați la 800-722-1471
(TTY: 800-842-5357).
한국어 (Korean):
본 통지서에는 중요한 정보가 들어 있습니다. 즉 이 통지서는 귀하의 신청에
관하여 그리고 Premera Blue Cross 를 통한 커버리지에 관한 정보를
포함하고 있을 수 있습니다. 본 통지서에는 핵심이 되는 날짜들이 있을 수
있습니다. 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기
위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다.
귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는
권리가 있습니다. 800-722-1471 (TTY: 800-842-5357) 로 전화하십시오.
Pусский (Russian):
Настоящее уведомление содержит важную информацию. Это
уведомление может содержать важную информацию о вашем
заявлении или страховом покрытии через Premera Blue Cross. В
настоящем уведомлении могут быть указаны ключевые даты. Вам,
возможно, потребуется принять меры к определенным предельным
срокам для сохранения страхового покрытия или помощи с расходами.
Вы имеете право на бесплатное получение этой информации и
помощь на вашем языке. Звоните по телефону 800-722-1471
(TTY: 800-842-5357).
ລາວ (Lao):
ແຈ້ ງການນ້ີ ມີຂ້ໍ ມູ ນສໍາຄັ ນ. ແຈ້ ງການນ້ີ ອາດຈະມີຂ້ໍ ມູ ນສໍາຄັ ນກ່ ຽວກັ ບຄໍາຮ້ ອງສະ
ໝັ ກ ຫື ຼ ຄວາມຄຸ້ ມຄອງປະກັ ນໄພຂອງທ່ ານຜ່ ານ Premera Blue Cross. ອາດຈະມີ
ວັ ນທີສໍາຄັ ນໃນແຈ້ ງການນີ້. ທ່ ານອາດຈະຈໍາເປັນຕ້ ອງດໍາເນີນການຕາມກໍານົ ດ
ເວລາສະເພາະເພື່ອຮັ ກສາຄວາມຄຸ້ ມຄອງປະກັ ນສຸ ຂະພາບ ຫື ຼ ຄວາມຊ່ ວຍເຫື ຼ ອເລື່ອງ
ຄ່ າໃຊ້ ຈ່ າຍຂອງທ່ ານໄວ້ . ທ່ ານມີສິດໄດ້ ຮັ ບຂ້ໍ ມູ ນນ້ີ ແລະ ຄວາມຊ່ ວຍເຫື ຼ ອເປັນພາສາ
ຂອງທ່ ານໂດຍບໍ່ເສຍຄ່ າ. ໃຫ້ ໂທຫາ 800-722-1471 (TTY: 800-842-5357).
ភាសាែខម រ (Khmer):
េសចកត ីជូនដំណឹងេនះមានព័ត៌មានយា៉ងសំខាន់។ េសចកត ីជូនដំណឹងេនះរបែហល
ជាមានព័ត៌មានយា៉ងសំខាន់អំពីទរមង់ែបបបទ ឬការរា៉ប់រងរបស់អនកតាមរយៈ
Premera Blue Cross ។ របែហលជាមាន កាលបរ ិេចឆ ទសំខាន់េនៅកនុងេសចកត ីជូន
ដំណឹងេនះ។ អន ករបែហលជារតូវការបេញច ញសមតថ ភាព ដល់កំណត់ៃថង ជាក់ចបាស់
នានា េដើមបីនឹងរកសាទុកការធានារា៉ប់រងសុខភាពរបស់អនក ឬរបាក់ជំនួយេចញៃថល ។
អន កមានសិទធិទទួ លព័ត៌មានេនះ និងជំនួយេនៅកនុងភាសារបស់អនកេដាយមិនអស
លុយេឡើយ។ សូ មទូ រស័ពទ 800-722-1471 (TTY: 800-842-5357)។
ਪੰ ਜਾਬੀ (Punjabi):
ਇਸ ਨੋਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹੈ. ਇਸ ਨੋਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤੁਹਾਡੀ
ਕਵਰੇਜ ਅਤੇ ਅਰਜੀ ਬਾਰੇ ਮਹੱ ਤਵਪੂਰਨ ਜਾਣਕਾਰੀ ਹੋ ਸਕਦੀ ਹੈ . ਇਸ ਨੋਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ
ਹੋ ਸਕਦੀਆਂ ਹਨ. ਜੇਕਰ ਤੁਸੀ ਜਸਹਤ ਕਵਰੇਜ ਿਰੱ ਖਣੀ ਹੋਵੇ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵੱ ਚ ਮਦਦ ਦੇ
ਇਛੁੱ ਕ ਹੋ ਤਾਂ ਤੁਹਾਨੂੰ ਅੰ ਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾਂ ਕੁੱ ਝ ਖਾਸ ਕਦਮ ਚੁੱ ਕਣ ਦੀ ਲੋ ੜ ਹੋ ਸਕਦੀ ਹੈ ,ਤੁਹਾਨੂੰ
ਮੁਫ਼ਤ ਿਵੱ ਚ ਤੇ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵੱ ਚ ਜਾਣਕਾਰੀ ਅਤੇ ਮਦਦ ਪ੍ਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹੈ ,ਕਾਲ
800-722-1471 (TTY: 800-842-5357).
‫( فارسی‬Farsi):
‫اين اعالميه ممکن است حاوی اطالعات مھم درباره فرم‬. ‫اين اعالميه حاوی اطالعات مھم ميباشد‬
‫ به تاريخ ھای مھم در‬.‫ باشد‬Premera Blue Cross ‫تقاضا و يا پوشش بيمه ای شما از طريق‬
‫شما ممکن است برای حقظ پوشش بيمه تان يا کمک در پرداخت ھزينه‬. ‫اين اعالميه توجه نماييد‬
‫شما حق‬. ‫ به تاريخ ھای مشخصی برای انجام کارھای خاصی احتياج داشته باشيد‬،‫ھای درمانی تان‬
‫ برای کسب‬.‫اين را داريد که اين اطالعات و کمک را به زبان خود به طور رايگان دريافت نماييد‬
‫( تماس‬800-842-5357 ‫ تماس باشماره‬TTY ‫ )کاربران‬800-722-1471 ‫اطالعات با شماره‬
.‫برقرار نماييد‬
Polskie (Polish):
To ogłoszenie może zawierać ważne informacje. To ogłoszenie może
zawierać ważne informacje odnośnie Państwa wniosku lub zakresu
świadczeń poprzez Premera Blue Cross. Prosimy zwrócic uwagę na
kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie
przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej lub
pomocy związanej z kosztami. Macie Państwo prawo do bezpłatnej
informacji we własnym języku. Zadzwońcie pod 800-722-1471
(TTY: 800-842-5357).
Português (Portuguese):
Este aviso contém informações importantes. Este aviso poderá conter
informações importantes a respeito de sua aplicação ou cobertura por meio
do Premera Blue Cross. Poderão existir datas importantes neste aviso.
Talvez seja necessário que você tome providências dentro de
determinados prazos para manter sua cobertura de saúde ou ajuda de
custos. Você tem o direito de obter esta informação e ajuda em seu idioma
e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357).
Fa’asamoa (Samoan):
Atonu ua iai i lenei fa’asilasilaga ni fa’amatalaga e sili ona taua e tatau
ona e malamalama i ai. O lenei fa’asilasilaga o se fesoasoani e fa’amatala
atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua
atu i ai. Fa’amolemole, ia e iloilo fa’alelei i aso fa’apitoa olo’o iai i lenei
fa’asilasilaga taua. Masalo o le’a iai ni feau e tatau ona e faia ao le’i aulia le
aso ua ta’ua i lenei fa’asilasilaga ina ia e iai pea ma maua fesoasoani mai ai
i le polokalame a le Malo olo’o e iai i ai. Olo’o iai iate oe le aia tatau e maua
atu i lenei fa’asilasilaga ma lenei fa’matalaga i legagana e te malamalama i
ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471
(TTY: 800-842-5357).
Español (Spanish):
Este Aviso contiene información importante. Es posible que este aviso
contenga información importante acerca de su solicitud o cobertura a
través de Premera Blue Cross. Es posible que haya fechas clave en este
aviso. Es posible que deba tomar alguna medida antes de determinadas
fechas para mantener su cobertura médica o ayuda con los costos. Usted
tiene derecho a recibir esta información y ayuda en su idioma sin costo
alguno. Llame al 800-722-1471 (TTY: 800-842-5357).
Tagalog (Tagalog):
Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang
paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon
tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue
Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring
mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang
panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na
walang gastos. May karapatan ka na makakuha ng ganitong impormasyon
at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471
(TTY: 800-842-5357).
ไทย (Thai):
ประกาศนี ้มีข้อมูลสําคัญ ประกาศนี ้อาจมีข้อมูลที่สําคัญเกี่ยวกับการการสมัครหรื อขอบเขตประกัน
สุขภาพของคุณผ่าน Premera Blue Cross และอาจมีกําหนดการในประกาศนี ้ คุณอาจจะต้ อง
ดําเนินการภายในกําหนดระยะเวลาที่แน่นอนเพื่อจะรักษาการประกันสุขภาพของคุณหรื อการช่วยเหลือที่
มีค่าใช้ จ่าย คุณมีสิทธิที่จะได้ รับข้ อมูลและความช่วยเหลือนี ้ในภาษาของคุณโดยไม่มีค่าใช้ จ่าย โทร
800-722-1471 (TTY: 800-842-5357)
Український (Ukrainian):
Це повідомлення містить важливу інформацію. Це повідомлення
може містити важливу інформацію про Ваше звернення щодо
страхувального покриття через Premera Blue Cross. Зверніть увагу на
ключові дати, які можуть бути вказані у цьому повідомленні. Існує
імовірність того, що Вам треба буде здійснити певні кроки у конкретні
кінцеві строки для того, щоб зберегти Ваше медичне страхування або
отримати фінансову допомогу. У Вас є право на отримання цієї
інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за
номером телефону 800-722-1471 (TTY: 800-842-5357).
Tiếng Việt (Vietnamese):
Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông
tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua
chương trình Premera Blue Cross. Xin xem ngày quan trọng trong thông
báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn
để duy trì bảo hiểm sức khỏe hoặc được trợ giúp thêm về chi phí. Quý vị có
quyền được biết thông tin này và được trợ giúp bằng ngôn ngữ của mình
miễn phí. Xin gọi số 800-722-1471 (TTY: 800-842-5357).