Continuous ambulatory electrocardiography patch …...multisensor electrocardiography monitors (Heart Rhythm Society, 2017). One of these categories, electrocardiography patch devices,

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Clinical Policy Title: Continuous ambulatory electrocardiography patch

monitoring

Clinical Policy Number: CCP.1337

Effective Date: October 1, 2017

Initial Review Date: September 21, 2017

Most Recent Review Date: October 2, 2018

Next Review Date: October 2019

Related policies:

None.

ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas’ clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas’ clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas’ clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas’ clinical policies are not guarantees of payment.

Coverage policy

AmeriHealth Caritas considers the use of continuous ambulatory electrocardiography patch monitoring

to be investigational/experimental and, therefore, not medically necessary.

Limitations:

None.

Alternative covered services:

External memory loop devices.

Holter monitors.

Implantable memory loop devices.

Mobile cardiac telemetry systems (Schreiber, 2014).

Policy contains:

Atrial fibrillation.

Holter monitor.

SEEQ® MCT.

ZIO Patch.

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Background

Arrhythmia, or irregular heartbeat, is a condition that may lead to stroke or heart failure. The most

common form of arrhythmia is atrial fibrillation, which affects 2.7 to 6.1 million Americans. At age 40,

the lifetime risk of atrial fibrillation is 26 percent for men and 23 percent for women (Lloyd-Jones, 2004).

In a comparison of persons with congenital heart disease with versus without atrial arrhythmia, risk was

significantly higher for those with the condition for any adverse event (hazard ratio 2.50, P < .0001), for

mortality (1.47, P < .001), for stroke or heart failure (2.21, P < .001), and for cardiac interventions (3.00,

P < 0.001) (Bouchardy, 2009). Because the highest rates occur in elderly populations, overall prevalence

is projected to increase substantially in the future (U.S. Centers for Disease Control and Prevention,

2017).

Electrocardiography has long been an effective means to monitor heart rhythm. The introduction of the

Holter monitor in the 1960s enabled providers to collect helpful data outside the institutional setting, as

these devices can capture continuous data on heartbeat for 24 hours. However, an under-use of this

service exists in at-risk populations. In 17,398 patients treated at Ontario stroke centers from 2003 to

2013 with a first acute ischemic stroke or transient ischemic attack in sinus rhythm without known atrial

fibrillation, only 30.6 percent received a Holter monitor for at least 24 hours (less than one percent at

least 48 hours) within 30 days of a stroke or transient ischemic attack (Edwards, 2016).

Electrocardiography is useful for patients who are asymptomatic, or who suffer from symptoms such as

anxiety, dizziness, fatigue, light-headedness, palpitations, pre-syncope, shortness of breath, and

syncope.

More than one day of monitoring may be needed to detect arrhythmias. Thus, new technologies have

developed other ambulatory cardiac monitoring devices, including patch monitors, external loop

recorders, external non-loop recorders, smart phone monitors, mobile cardiac telemetry, implantable

loop recorders, pacemakers and implantable cardioverter defibrillators with atrial leads, and wearable

multisensor electrocardiography monitors (Heart Rhythm Society, 2017).

One of these categories, electrocardiography patch devices, may be worn for much longer periods while

collecting continuous data have been developed in recent years. The ZIO XT system (iRhythm

Technologies Inc.) is small, at three inches in length and 34 grams in weight (Holter monitors are

between 100 and 150 grams). It is a wireless, water resistant, adhesive patch that consists of one chip

and two electrodes, and continually sticks to the chest for up to 14 days at a time. Approved for use by

the U.S. Food and Drug Administration in July 2012, the ZIO uses hydrogel electrodes for clearer

electrocardiography tracings. However, ZIO requires the user to mail the device to a cardiologist after

use, delaying the time when results are obtained and a diagnosis made (Fung, 2015).

Another new electrocardiography patch is the NUVANT® or SEEQ mobile cardiac telemetry system

(Medtronic Inc.). Like the ZIO, the SEEQ has a wireless transmitter, and also makes a continual recording

of the heartbeat, but for up to 7.5 days at a time. Also approved by the Food and Drug Administration, it

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weighs 50 grams, and includes a battery charger. It transmits data to the Medtronic Monitoring Center

for continuous monitoring (Fung, 2015).

Another federally-approved device, known as the V-patch (Vpatch CardioPty Ltd.), allows the patient to

wear a small device continually for seven days, as the heartbeat is being monitored in real time.

Ambulatory wireless electrocardiography patch monitors have grown rapidly in popularity. In Ontario,

Canada, the volume of such monitors increased from 638 to 37,191 between 2006 and 2014. The

projection for 2020 ranges from 57,289 to 102,829, depending on the growth trend (Health Services

Ontario, 2017).

Technologies other than wireless patches have recently been developed. The extended external auto-

trigger loop recorder can record ambulatory heartbeat patterns for seven days. The scope of this policy,

however, will be limited to wireless patches.

Searches

AmeriHealth Caritas searched PubMed and the databases of:

UK National Health Services Centre for Reviews and Dissemination.

Agency for Healthcare Research and Quality’s National Guideline Clearinghouse and other

evidence-based practice centers.

The Centers for Medicare & Medicaid Services.

We conducted searches on August 2, 2018. Search terms were: “ECG Patch Monitoring,” “ZIO Patch,”

“SEEQ,” and “V-patch.”

We included:

Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and

greater precision of effect estimation than in smaller primary studies. Systematic reviews use

predetermined transparent methods to minimize bias, effectively treating the review as a

scientific endeavor, and are thus rated highest in evidence-grading hierarchies.

Guidelines based on systematic reviews.

Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost

studies), reporting both costs and outcomes — sometimes referred to as efficiency studies —

which also rank near the top of evidence hierarchies.

Findings

The May 2017 Heart Rhythm Society Atrial Fibrillation Consensus Statement includes patch monitors as

one method of ambulatory electrocardiography monitoring (Calkins, 2017). The March 2017 American

College of Cardiology/American Heart Association/Heart Rhythm Society Guideline for the Evaluation

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and Management of Patients with Syncope listed patch monitoring as one of five recommended

approaches to electrocardiography monitoring (Shen, 2017). The July 2017 Expert Consensus Statement

from the International Society for Holter and Noninvasive Electrocardiology and the Heart Rhythm

Society recommends 24- – 48- hour Holter Monitoring for quantitative ECG analysis, but also supports

continuous monitoring for 1 to 14 days when additional data on trends are needed, without using the

specific term “patch monitoring” (Steinberg, 2017).

No systematic reviews or meta-analyses addressing the efficacy of continuously-work ambulatory

electrocardiography patches have been published in the medical literature.

A randomized controlled trial analyzed the ability of ambulatory patches to detect atrial fibrillation in

high-risk individuals. Subjects wore a self-applied continuous electrocardiography monitoring patch at

home for up to four weeks, initiated either immediately after enrolling (n = 1364) or four months after

enrollment (n = 1291). By the four-month mark, new cases of atrial fibrillation was significantly greater

in the group with immediate initiation (53 versus 12 cases, or 3.9 versus 0.9 percent), leading to greater

rates of primary care visits and increased initiation of anticoagulants (Steinhubl, 2018).

Articles from recent conference proceedings of the Engineering in Medicine and Biology Society of the

Institute of Electrical and Electronics Engineers addressed various aspects of the SEEQ device. The lead

author of each study was Jonathan Engel of Corventis, a St. Paul, Minnesota, company that developed

SEEQ. Findings include:

SEEQ was a factor in improper application in 2.3 percent of patients using the device (Engel,

2011).

In a group of 951 patients, SEEQ detected arrhythmias with significant tachycardia in 2.2 percent

of patients, potential brachycardia in 19 percent, atrial fibrillation in 20 percent, and

arrhythmias not likely to require treatment in another 58 percent (Engel, 2012).

In a study of 2,231 U.S. patients and 1,053 patients from India with the SEEQ device, specific

arrhythmia types were similar between the two nations, except that U.S. elderly had higher

prevalence of atrial fibrillation and flutter (Engel, 2014).

Varying weather conditions do not degrade SEEQ’s ability to detect event rates (Engel, 2015).

A comparative study of 146 patients referred for evaluation of cardiac arrhythmia underwent

simultaneous ambulatory electrocardiography recording with a conventional Holter monitor and a ZIO

adhesive patch monitor. The median days of monitoring were 1.0 and 11.1, respectively, and the median

age of patients was 64. ZIO detected significantly more total arrhythmia events than did the Holter (96

versus 61, P <. 001). In the first 24 hours of monitoring, Holter monitors detected 61 arrhythmias

compared to 52 for the ZIO (P < .01). The ZIO detected two events that the Holter did not; and the

Holter detected 11 that the ZIO did not (10 of these later found by the ZIO). Significantly more patients

found the ZIO comfortable (93.7 versus 51.7 percent), while significantly fewer stated that ZIO affected

activities of daily living (10.5 percent versus 76.2 percent). Most (81 percent) preferred ZIO overall.

Partial funding for this study was from iRhythm Technologies, developers of the ZIO device (Barrett,

2014).

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Another comparative study of 74 patients at Beth Israel Deaconness Medical Center in Boston who were

monitored simultaneously with Holter monitors (median 1.0 days) and ZIO patches (median 10.8 days)

found no significant difference in atrial fibrillation burden between the two (58.4 for Holter, 54.7 for

ZIO). Atrial fibrillation was identified in 18 more patients using ZIO. Authors state that the data are

promising for ZIO, but they call for large efficacy studies. Support for the study came from iRhythm

(Rosenberg, 2013). A non-comparative study of 75 elderly males prospectively screened with the ZIO

Patch documented that atrial tachycardia was present in 67 percent (more than four beats) and 44

percent (more than eight beats). The study received in-kind support from iRhythm (Turakhia, 2015).

A review of 26,751 patients using ZIO for the first time reported a mean wearing time of 7.6 days; only

16 percent wore the device for the full two-week capacity. Authors focus on rates of arrhythmia

detection after the first 48 hours, which is typically the maximum wearing time for Holter monitors.

Findings include 29.9 percent of first arrhythmias occurred and 51.1 percent of symptom-triggered

arrhythmias occurred after 48 hours. Additional detection improved the percent (after 48 hours versus

total wearing time) of any arrhythmia from 43.9 percent to 62.2 percent, and of symptomatic

arrhythmias from 4.4 to 9.7 percent, both significant at P < .0001. One of the authors was the founder

and Chief Medical Officer of iRhythm, inventor of ZIO (Turakhia, 2013).

A review discusses 1,171 reports of patients who were monitored using the ZIO Patch in 2012 and 2013.

The median wear time was 13.0 days. The review determined atrial fibrillation was present in 5.0

percent of all patients; 14.3 percent of first paroxysmal atrial fibrillation occurred after 48 hours of wear.

The study was funded by iRhythm (Tung, 2015).

A study of 3,209 children receiving the ZIO Patch for 14 days in the three-year period 2011 to 2013

showed that 390 (12.2 percent) had a detected arrhythmia, and 137 (4.3 percent) had arrhythmias

deemed clinically significant to warrant urgent physician notification. The percent of first detected

arrhythmias and first symptom-triggered arrhythmias after 48 hours of monitoring were 44.0 and 50.4

percent, respectively. This study was funded by the manufacturer (Bolourchi, 2015).

A total of 332 children age under 18 with a need for electrocardiography monitoring wore the ZioTM

patch for up to two weeks (median five days). The device identified arrhythmias requiring new

intervention or medical management in 5.1 percent of subjects, and arrhythmias requiring greater

clinical surveillance in 4.0 percent. For patients requiring increased surveillance or intervention 56

percent were detected after more than 24 hours of wearing the patch (May, 2018).

A non-randomized review analyzed the care of 174 patients from three California and Texas emergency

departments with symptoms of possible cardiac arrhythmia (mostly palpitations, syncope, and dizziness)

discharged with ZIO, worn for an average of 6.9 days. A total of 83 patients (47.7 percent) had one or

more arrhythmias, and 17 (9.8 percent) were symptomatic at the time of first arrhythmia. The median

times to the first arrhythmia and first symptomatic arrhythmia were 1.0 and 1.5 days, respectively.

Overall diagnostic yield was 63.2 percent, defined as the number of triggered events without

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arrhythmias (n = 93) and the number of significant symptomatic arrhythmias detected (n = 17); the 63.2

percent figure was higher than yields from Holter monitors. Authors concluded that ZIO was efficient

characterizing symptomatic patients without significant arrhythmia. No manufacturer played any role in

this review (Schreiber, 2014).

A randomized controlled trial testing the ZIO ability to detect paroxysmal atrial fibrillation in two United

Kingdom medical centers aimed to enroll 120 patients. Interim results from August 2016 showed

paroxysmal atrial fibrillation detection in four of 17 cases in the active arm versus zero of 17 cases in the

control arm. No manufacturers are involved with this ongoing study (Teo, 2017).

Members of the arrhythmia service in a Vancouver, British Columbia, medical center, who were not

affiliated with any electrocardiography patch manufacturer, commented on the Barrett study of the ZIO

Patch. Their belief that these patches “represent the changing face of ambulatory ECG monitoring” is

accompanied by a list of concerns (loss of quality, automated rhythm analysis, inability to detect

myocardial ischemia) that still need to be addressed (Cheung, 2014).

Policy updates:

A total of three peer-reviewed references were added to, and one removed from, this policy in August,

2018.

Summary of clinical evidence:

Citation Content, Methods, Recommendations

Steinhubl (2018)

Ambulatory patches

detecting atrial fibrillation in

high-risk individuals

Key points:

Randomized controlled trial of 2655 individuals at high risk for atrial fibrillation.

Subjects all wore a self-applied continuous electrocardiography monitoring patch at

home for up to four weeks.

Group initiated monitor immediately after enrolling (n = 1364) or four months after

enrollment (n = 1291).

By the four-month mark, new cases of atrial fibrillation was significantly greater in the

group with immediate initiation (53 versus 12 cases, or 3.9 versus 0.9 percent (%), 95

percent confidence interval (CI) 1.8%-4.1%).

The active monitoring group had more subjects with anticoagulant initiation (5.7 versus

3.7 per 100 person-years, 95% CI, 1.9-2.2); outpatient cardiology visits (33.5 versus

26.0 per 100 person-years, 95% CI, 7.2-7.9); and primary care visits (83.5 versus 82.6

per 100 person-years, 95% CI, 0.4-1.5).

Barrett (2014)

Comparison of Holter

monitor and ZIO Patch

Key points:

Comparison of ambulatory electrocardiography recording with Holter monitor and ZIO

adhesive patch in 146 patients referred for evaluation of cardiac arrhythmia.

Median days of monitoring were 1.0 for Holter monitors and 11.1 for ZIO adhesive

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Citation Content, Methods, Recommendations

patches, respectively.

ZIO found significantly more total arrhythmia events than the Holter (96 versus 61, P <

.001).

In the first 24 hours, Holter monitors detected 61 arrhythmias versus 52 for the ZIO (P <

.01).

Significantly more patients found the ZIO comfortable (93.7% versus 51.7%),

significantly fewer stated that ZIO affected activities of daily living (10.5% versus

76.2%), and 81% preferred ZIO overall.

Partial funding was from iRhythm Technologies, developer of ZIO.

Cheung (2014)

Observations of

improvements and concerns

about ZIO Patch

Key points:

Response to the Barrett study by members of a Canadian arrhythmia service.

Authors state that patches “represent the changing face of ambulatory ECG monitoring.”

Concerns that need to be addressed include loss of quality, automated rhythm analysis,

and inability to detect myocardial ischemia.

Schreiber (2014)

Key points:

Review of 174 patients with symptoms of possible cardiac arrhythmia, discharged with

ZIO Patch, which were worn for an average of 6.9 days.

47.7 percent (%) had one or more arrhythmia, and 9.8% were symptomatic at first

arrhythmia.

Median times to first arrhythmia or first symptomatic arrhythmia were 1.0 and 1.5 days.

Overall diagnostic yield (number of triggered events without arrhythmias) was 63.2%,

much higher than yields from Holter monitors.

No manufacturer played any role in the review.

Turakhia (2013) Key points:

Study of 26,751 patients using ZIO for the first time.

Mean wearing time of 7.6 days; only 16 percent wore the device for the full two-week

capacity.

29.9% of first arrhythmias occurred and 51.1 percent of symptom-triggered arrhythmias

occurred after 48 hours (maximum time wearing Holter monitor).

One of the authors was a founder and Chief Medical Officer of iRhythm, inventor of ZIO.

References

Professional society guidelines/other:

Calkins H, Hindricks G, Cappato R, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus

Statement on Catheter and Surgical Ablation of Atrial Fibrillation. Heart Rhythm Society (HRS), May 12,

2017. http://www.hrsonline.org/Policy-Payment/Clinical-Guidelines-Documents/2017-HRS-EHRA-ECAS-

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APHRS-SOLAECE-Expert-Consensus-Statement-on-Catheter-and-Surgical-Ablation-of-Atrial-Fibrillation.

Accessed August 30, 2017.

Shen WK, Sheldon RS, Benditt DG, et al. 2017 ACC/AHA/HRS guideline for the evaluation and

management of patients with syncope: A report of the American College of Cardiology/American Heart

Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Heart Rhythm.

2017;14(8):e155-e217. Doi: 10.1016/j.hrthm.2017.03.004.

Steinberg JS, Varma N, Cygankiewicz I. 2017 ISHNE-HRS expert consensus statement on ambulatory ECG

and external cardiac monitoring/telemetry. Heart Rhythm. 2017;14(7):e55-e96. Doi:

10.1016/j.hrthm.2017.03.038.

U.S. Centers for Disease Control and Prevention, Division for Heart Disease and Stroke Prevention. Atrial

Fibrillation Fact Sheet. Atlanta GA: U.S. Centers for Disease Control and Prevention, 2017.

https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm. Accessed August 3,

2018.

Peer-reviewed references:

Barrett PM, Komatireddy R, Haaser S. Comparison of 24-hour Holter monitoring with 14-day novel

adhesive patch electrocardiographic monitoring. Am J Med. 2014;127(1):95.e11-17. Doi:

10.1016/j.amjmed.2013.10.003.

Bolourchi M, Batra AS. Diagnostic yield of patch ambulatory electrocardiogram monitoring in children

(from a national registry). Am J Cardiol. 2015;115(5):630-634. Doi: 10.1016/j.amjcard.2014.12.014.

Bouchardy J, Therrien J, Pilote L, et al. Atrial arrhythmias in adults with congenital heart disease.

Circulation. 2009;120(17):1679-1686. Doi: 10.1161/CIRCULATIONAHA.109.866319.

Cheung CC, Kerr CR, Krahn AD. Comparing 14-day adhesive patch with 24-h Holter monitoring. Future

Cardiol. 2014;10(3):319-322. Doi: 10.2217/fca.14.24.

Edwards JD, Kapral MK, Fang J, Saposnik G, Gladstone DJ, Investigators of the Registry of the Canadian

Stroke Network. Underutilization of ambulatory ECG monitoring after stroke and transient ischemic

attack: missed opportunities for atrial fibrillation detection. Stroke. 2016;47(8):1982-1989. Doi:

10.1161/STROKEAHA.115.012195.

Engel JM, Chakravarthy N, Katra RP, Mazar S, Libbus I, Chavan A. Estimation of patient compliance in

application of adherent mobile cardiac telemetry device. Conf Proc IEEE Eng Med Biol Soc.

2011;2011:1536-1539. Doi: 10.1109/IEMBS.2011.6090448.

Engel JM, Mehta V, Fogoros R, Chavan A. Study of arrhythmia prevalence in NUVANT Mobile Cardiac

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Telemetry system patients. Conf Proc IEEE Eng Med Biol Soc. 2012;2012:2440-2443. Doi:

10.1109/EMBC.2012.6346457.

Engel JM, Chakravarthy N, Nosbush G, Merkert M, Fogoros R, Chavan A. Comparison of arrhythmia

prevalence in NUVANT Mobile Cardiac Telemetry System patients in the US and India. Conf Proc IEEE

Eng Med Biol Soc. 2014;2014:2730-2733. Doi: 10.1109/EMBC.2014.6944187.

Engel JM, Chakravarthy BL, Rothwell D, Chavan A. SEEQ™ MCT wearable sensor performance correlated

to skin irritation and temperature. Conf Proc IEEE Eng Med Biol Soc. 2015;2015:2030-2033. Doi:

10.1109/EMBC.2015.7318785.

Fung E, Jarvelin M-r, Doshi RN, et al. Electrocardiographic patch devices and contemporary wireless

cardiac monitoring. Front Physiol. 2015;6:149. Doi: 10.3389/fphys.2015.00149. Doi:

10.3389/fphys.2015.00149.

Health Quality Ontario. Long-term continuous ambulatory ECG monitors and external cardiac loop recorders for cardiac arrhythmia: A health technology assessment. Ont Health Technol Assess Ser. 2017; 17(1):1-56.

Lloyd-Jones DM, Wang TJ, Leip EP, et al. Lifetime risk for development of atrial fibrillation: the

Framingham Heart Study. Circulation. 2004;110(9):1042-1046.

May JW, Carter EL, Hitt JR, Burklow TR. Clinical impact of a novel ambulatory rhythm monitor in children. Cardiol Young. 2018:1-7. Doi: 10.1017/S1047951118001142.

Rosenberg MA, Samuel M, Thosani A, Zimetbaum PJ. Use of a noninvasive continuous monitoring device

in the management of atrial fibrillation: a pilot study. Pacing Clin Electrophysiol. 2013;36(3):328-333.

Doi: 10.1111/pace.12053.

Schreiber D, Sattar A, Drigalla D, Higgins S. Ambulatory cardiac monitoring for discharged emergency

department patients with possible cardiac arrhythmias. West J Emerg Med. 2014;15(2):194-198. Doi:

10.5811/westjem.2013.11.18973.

Steinhubl SR, Waalen J, Edwards AM, et al. Effect of a home-based wearable continuous ECG

monitoring patch on detection of undiagnosed atrial fibrillation: The mSToPS randomized clinical trial.

JAMA. 2018;320(2):146-155. Doi: 10.1001/jama.2018.8102.

Teo JT, Lenane J, Sztriha L, et al. Randomised clinical trial of early prolonged ambulatory cardiac

monitoring after stroke (EPACS): interim analysis. American Heart Association/American Stroke

Association 2017 International Stroke Conference and State-of-the-Science Stroke Nursing Symposium.

Cochrane Central Register of Controlled Trials. 2017(8).

http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/783/CN-01398783/frame.html. Accessed

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August 3, 2018.

Tung CE, Su D, Turakhia MP, Lansberg MG. Diagnostic yield of extended cardiac patch monitoring in

patients with stroke or TIA. Front Neurol. 2015;5:266. Doi: 10.3389/fneur.2014.00266.

Turakhia MP, Hoang DD, Zimetbaum P, et al. Diagnostic utility of a novel leadless arrhythmia monitoring

device. Am J Cardiol. 2013;112(4):520-524. Doi: 10.1016/j.amjcard.2013.04.017.

Turakhia MP, Ullal AJ, Hoang DD, et al. Feasibility of extended ambulatory electrocardiogram monitoring

to identify silent atrial fibrillation in high-risk patients: the screening study for undiagnosed atrial

fibrillation (STUDY-AF). Clin Cardiol. 2015;38(5):285-292. Doi: 10.1002/clc.22387.

Walsh JA 3rd, Topol EJ, Steinhubl SR. Novel wireless devices for cardiac monitoring. Circulation.

2014;130(7):573-581. Doi: 10.1161/CIRCULATIONAHA.114.009024.

Centers for Medicare & Medicaid Services National Coverage Determinations:

No National Coverage Determinations identified as of the writing of this policy.

Local Coverage Determinations:

No Local Coverage Determinations identified as of the writing of this policy.

Commonly submitted codes

Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is

not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and

bill accordingly.

CPT Code Description Comments

33282 Implantation of patient-activated cardiac event recorder

33284 Removal of an implantable, patient-activated cardiac event recorder

93224-93227 Electrocardiographic monitoring [Holter monitors and other event recording]

93228

External mobile cardiovascular telemetry with electrocardiographic recording,

concurrent computerized real time data analysis and greater than 24 hours of

accessible ECG data storage (retrievable with query) with ECG triggered and

patient selected events transmitted to a remote attended surveillance center for

up to 30 days; review and interpretation with report by a physician or other

qualified health care professional

93229

External mobile cardiovascular telemetry with electrocardiographic recording,

concurrent computerized real time data analysis and greater than 24 hours of

accessible ECG data storage (retrievable with query) with ECG triggered and

patient selected events transmitted to a remote attended surveillance center for

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CPT Code Description Comments

up to 30 days; technical support for connection and patient instructions for use,

attended surveillance, analysis and transmission of daily and emergent data

reports as prescribed by a physician or other qualified health care professional

93268

External patient and, when performed, auto activated electrocardiographic

rhythm derived event recording with symptom-related memory loop with remote

download capability up to 30 days, 24-hour attended monitoring; includes

transmission, review and interpretation by a physician or other qualified health

care professional

93271

External patient and, when performed, auto activated electrocardiographic

rhythm derived event recording with symptom-related memory loop with remote

download capability up to 30 days, 24-hour attended monitoring; transmission

and analysis

93272

External patient and, when performed, auto activated electrocardiographic

rhythm derived event recording with symptom-related memory loop with remote

download capability up to 30 days, 24-hour attended monitoring; review and

interpretation by a physician or other qualified health care professional

93285

Programming device evaluation (in person) with iterative adjustment of the

implantable device to test the function of the device and select optimal

permanent programmed values with analysis, review and report by a physician

or other qualified health care professional; implantable loop recorder system

93291

Interrogation device evaluation (in person) with analysis, review and report by a

physician or other qualified health care professional, includes connection,

recording and disconnection per patient encounter; implantable loop recorder

system, including heart rhythm derived data analysis

93298

Interrogation device evaluation(s), (remote) up to 30 days; implantable loop

recorder system, including analysis of recorded heart rhythm data, analysis,

review(s) and report(s) by a physician or other qualified health care professional

93299

Interrogation device evaluation(s), (remote) up to 30 days; implantable

cardiovascular monitor system or implantable loop recorder system, remote data

acquisition(s), receipt of transmissions and technician review, technical support

and distribution of results

0295T

External electrocardiographic recording for more than 48 hours up to 21 days by

continuous rhythm recording and storage; includes recording, scanning analysis

with report, review and interpretation

0296T

External electrocardiographic recording for more than 48 hours up to 21 days by

continuous rhythm recording and storage; recording (includes connection and

initial recording)

0297T External electrocardiographic recording for more than 48 hours up to 21 days by

continuous rhythm recording and storage; scanning analysis with report

0298T External electrocardiographic recording for more than 48 hours up to 21 days by

continuous rhythm recording and storage; review and interpretation

ICD-10 Code Description Comments

I44.0 - I45.9 Atrioventricular and left bundle-branch block and other conduction disorders

I47.0 - I49.9 Paroxysmal tachycardia, atrial fibrillation and flutter, and other cardiac

arrhythmias

I63.00 - I63.9 Cerebral infarction

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ICD-10 Code Description Comments

R00.2 Palpitations

R42 Dizziness and giddiness [light-headedness]

R55 Syncope and collapse

R94.31 Abnormal electrocardiogram [ECG] [EKG]

Z86.73 Personal history of transient ischemic attack (TIA), and cerebral infarction

without residual deficits

HCPCS

Level II Code Description Comments

C1764 Event recorder, cardiac (implantable)

E0616 Implantable cardiac event recorder with memory, activator, and programmer