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Page 1 of 9 Proprietary Information of Blue Cross and Blue Shield of Alabama

Medical Policy #460

Name of Policy: Mobile Cardiac Outpatient Telemetry and Hybrid Devices Policy #: 460 Latest Review Date: January 2015 Category: Medical Policy Grade: Effective January 2,

2013, this remains an active policy but no longer scheduled for regular literature reviews and updates.

Background/Definitions: As a general rule, benefits are payable under Blue Cross and Blue Shield of Alabama health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage. The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome; 4. The technology must be as beneficial as any established alternatives; 5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and 2. Clinically appropriate in terms of type, frequency, extent, site and duration and

considered effective for the patient’s illness, injury or disease; and 3. Not primarily for the convenience of the patient, physician or other health care provider;

and 4. Not more costly than an alternative service or sequence of services at least as likely to

produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.

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Medical Policy #460

Description of Procedure or Service: Ambulatory event monitors store recorded cardiac rhythm data, which are ultimately transmitted either to a physician’s office or to a central recording station. In contrast to Holter monitors or event records, outpatient cardiac telemetry is real-time outpatient cardiac monitoring system that is automatically activated and requires no patient intervention to either capture or transmit an arrhythmia when it occurs. Upon arrhythmia detection, the device utilizes a standard telephone line or wireless communications and transmits the electrocardiogram (EKG) waveform to the receiving center. The patient’s physician is made aware of arrhythmias based on pre-determined notification criteria, tailored to the patient by the physician. Real-time cardiac monitoring provides continuous (beat-to-beat) outpatient EKG monitoring for periods ranging up to several weeks. For example, CardioNet Inc. (Conshotlocken, PA) offers mobile cardiac outpatient telemetry (MCOT). In this system, the patient wears a three-lead sensor, which constantly communicates with the CardioNet monitor, a lightweight unit that can be carried in a pocket or a purse. Patients wear CardioNet MCOT for up to 21 days of monitoring. CardioNet monitors patients 24 hours a day via the small sensor and monitor the patient wears as they continue with their normal daily routine. As events occur, patient activity is automatically transmitted to the CardioNet Monitoring Center for analysis and response. The referring physician can request the level and timing of response, ranging from daily reports to stat results. Other systems for outpatient cardiac telemetry include the HEARTLink II system (Cardiac Telecom Corp.), the Vital Signs Transmitter (VST, Biowatch Medical, Columbia, SC), and the Lifestar Ambulatory Cardiac Telemetry (ACT) system (Card Guard Scientific Survival Ltd., Israel). The CardioNet system has a built-in cellular telephone that automatically transmits signals when the patient is away from home. The VectraplexECG™ System is a real-time continuous MCOT device to measure ischemic ECG changes that can be indicative of a myocardial infarction (MI). This device uses the Internet to communicate real-time ECG changes to the physician. The patient is hooked up to a mini- tablet by either five electrodes, which communicate 15-lead ECG data, or 10 electrodes that communicate 12-lead ECG data. While this system is primarily intended to monitor for ischemia, the continuous ECG monitoring would presumably detect rhythm disturbances, as well as ischemic changes. There are also hybrids or “extended daily monitoring” devices on the market. These are similar to traditional Holter monitoring in concept, but offer other advantages such as the ability to monitor for longer periods of time. The Zio® Patch system (iRhythm Technologies Inc., San Francisco, CA) is a long-term continuous monitoring system that is most analogous to a Holter monitor that records and stores information for longer time periods. It is primarily used for asymptomatic monitoring. This system consists of a patch worn over the left pectoral region of the body that records continuously for up to 14 days, while the patient keeps a symptom log. At the end of the recording period, the patient mails back the recorder in a prepaid envelope to a central station and a full report is provided to the physician within a few days.

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Medical Policy #460

The BodyGuardian Remote Monitoring System™ (Preventice® Inc., Minneapolis, MN) continuously detects and records a variety of physiologic data including ECG tracing, respiratory rate, and activity level for up to 30 days. The data can be transmitted to the physician’s office via a cellular telephone, and information can be viewed by the patient and physician through the internet. Another is the Verite´ (eCardio, Houston, Texas). The eCardio website describes this device as, “a multi-functional monitor with both event and telemetry monitoring capabilities, including automatic detection, capturing and communication of symptomatic events such as Atrial Fibrillation, Bradycardia, Tachycardia and Cardiac Pause. A remotely programmable feature of eCardio Verite´ allows eCardio’s monitoring center to seamlessly transition the monitor from a telemetry monitor to an event monitor when directed by a patient’s physician without any disruption to a patient’s monitoring study. eCardio Verite´ Features:

• Single component device with built-in symptom and activity capture • Patient-friendly monitor offers seamless transition between Telemetry and Event as

directed by physician • Advanced algorithm captures onset and offset of arrhythmias, including Atrial

Fibrillation • Beat-to-beat recordings stored for up to 30 days, regardless of wireless coverage • Customizable arrhythmia detection settings that are remotely programmable • Verite´ Initial Assessment provided for first 24 hours alleviating the need for most

preliminary Holter studies • Streamlined reports present six-second strips of interest with correlated symptoms and

activities” Policy: Outpatient cardiac telemetry (also known as mobile cardiac outpatient telemetry or MCOT) does not meet Blue Cross and Blue Shield of Alabama’s medical criteria for coverage as a diagnostic alternative in patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of cardiac arrhythmias (i.e., palpitations, dizziness, presyncope, or syncope). Hybrid or continuous ambulatory cardiac monitoring devices that record and store information for periods longer than 48 hours do not meet Blue Cross and Blue Shield of Alabama’s medical criteria for coverage and are considered investigational. See Policy #356 Ambulatory Event Monitors See Policy #461 Holter Monitoring (Ambulatory Electrocardiography) Blue Cross and Blue Shield of Alabama does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and

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Medical Policy #460

his/her patient. Blue Cross and Blue Shield of Alabama administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination. Key Points: Mobile Cardiac Outpatient Telemetry The published literature regarding outpatient cardiac telemetry was reviewed, with a specific focus on whether outpatient cardiac telemetry was associated with incremental benefit compared to the use of ambulatory event monitors. Of specific interest was the benefit of real-time monitoring in an ambulatory population, presumably considered to be at a lower level of risk from significant arrhythmia such that an electrophysiologic study or inpatient telemetry was not required. A number of uncontrolled case series report on outcomes of MCOT. One such published study described the outcomes of a consecutive case series of 100 patients. Patients with a variety of symptoms were included, including, most commonly, palpitations (47%), dizziness (24%), or syncope (19%), as well as efficacy of drug treatment (25%). Clinically significant arrhythmias were detected in 51% of patients, but half of these patients were asymptomatic. The authors comment that the automatic detection results in an increased diagnostic yield, but there was no discussion of its unique feature, i.e., the real-time analysis, transmission, and notification of arrhythmia. In another uncontrolled case series, Tayal et al reported on a retrospective analysis of patients with cryptogenic stroke, who had not been diagnosed with atrial fibrillation by standard monitoring. In this study, 13 of 56 patients (23%) with cryptogenic stroke were found to have atrial fibrillation with MCOT. Twenty-seven asymptomatic atrial fibrillation episodes were detected in the 13 patients, 23 of these were shorter than 30 seconds in duration. One randomized, controlled trial was identified that compared MCOT to standard event monitors. This study involved 305 patients who were randomly assigned to the LOOP recorder or MCOT and who were monitored for up to 30 days. The unblinded study enrolled patients at 17 centers for whom the investigators had a strong suspicion of an arrhythmic cause of symptoms including those with symptoms of syncope, presyncope, or severe palpitations occurring less frequently than once per 24 hours and a nondiagnostic 24-hour Holter or telemetry monitor within the prior 45 days. Test results were read in a blinded fashion by an electrophysiologist. The majority of patients in the control group had a patient-triggered event monitor. Only a subset of patients (n=50) had autotrigger devices, thus precluding a comparison between MCOT and auto-trigger devices. A diagnostic endpoint (confirmation/exclusion of arrhythmic cause of symptoms) was found in 88% of MCOT patients and in 75% of LOOP patients (p=0.008). The difference in rates was primarily due to detection of asymptomatic (not associated with simultaneous symptoms) arrhythmias in the MCOT group consisting of rapid atrial fibrillation and/or flutter (15 patients vs. one patient) and ventricular tachycardia defined as more than three beats and rate greater than 100 (14 patients vs. two patients). These were thought to be clinically significant rhythm disturbances and the likely causes of the patients’ symptoms. The paper does not comment on the

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Medical Policy #460

clinical impact (changes in management) of these findings in patients for whom the rhythm disturbance did not occur simultaneously with symptoms. In this study, the median time to diagnosis in the total study population was seven days in the MCOT group and nine days in the LOOP group. Kadish et al evaluated the frequency with which events transmitted by MCOT represented emergent arrhythmias, thereby indirectly assessing the clinical utility of real-time outpatient monitoring. A total of 26,438 patients who had undergone MCOT during a nine-month period were retrospectively examined. Of these patients, 21% (5,459) had an arrhythmic event requiring physician notification, and 1% (260) had an event that could be considered potentially emergent. These potentially emergent events included 120 patients with wide-complex tachycardia, 100 patients with sinus pauses six seconds or longer and 42 with sustained bradycardia at less than thirty beats per minute. MCOT is another option for long-term cardiac monitoring. The current evidence on MCOT establishes that it does record cardiac electric signals, without patient activation, for subsequent analysis. Currently, the literature does not provide any adequate comparative data for MCOT compared to the autotrigger device. One retrospective, uncontrolled study reported that only a small minority of events (1%) detected by MCOT were potentially emergent. None of the available studies have clearly shown an improvement in clinical utility as a result of using MCOT. Further study of MCOT is needed to compare MCOT with the autotrigger loop recorder in order to determine whether the faster response possible with real-time monitoring leads to improved outcomes. Continuous Monitors With Longer Recording Periods Newer devices are available that record cardiac rhythms continuously, but for longer periods of time than traditional Holter monitors. For example, the Zio® Patch continuously records and stores information for up to two weeks. In addition to recording information for longer periods of time, this device uses “near-field” recording electrodes that differ from most other devices. Several studies have evaluated the diagnostic yield of continuous monitoring for greater than 48 hours, either directly through comparison to Holter monitoring or indirectly through determination of the proportion of arrhythmias detected in the first 48 hours of monitoring. Tuakhia et al published a study in 2013 evaluating the diagnostic yield of the Zio Patch. Data from the manufacturer was used to identify 26,751 first-time users of the device. The most common clinical indications were palpitations (40.3%), atrial fibrillation (AF) (24.3%), and syncope (15.1%). The mean duration of use was 7.6±3.6 days, and 95.9% of patients wore the device for more than 48 hours. At least one episode of arrhythmia was detected in 16,142 patients (60.3%). The authors compared the detection rate in the first 48 hours with the detection rate over the entire time period that the device was worn, with 70.1% of patients having their arrhythmia detected within the first 48 hours and 29.9% having their first arrhythmia detected after the first 48 hours. The overall yield was significantly higher when comparing the total monitored period with the first 48 hours (62.2% vs 43.9%, p<0.001). These data confirm previous studies that have shown that a substantial proportion of arrhythmias in symptomatic

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Medical Policy #460

patients can be detected with a 48-hour period of monitoring and that longer monitoring periods increase the detection rate. Barrett et al published a comparison of arrhythmia detection rates in 146 patients who underwent simultaneous monitoring with a 24-hour Holter monitor and a 14-day Zio Patch monitor. Included were patients referred for evaluation of a suspected cardiac arrhythmia at single institution. For the detection of atrioventricular block, pause, polymorphic ventricular tachycardia, supraventricular tachycardia, or AF. Holter monitoring detected 61 arrhythmias, while the Zio Patch detected 96 (p<0.001). Over the course of the monitoring period, 60 arrhythmias were detected by both devices, with 36 detected by the Zio Patch that were not detected by Holter monitoring and one detected by the Holter that was not detected by the Zio Patch. The investigators conducted within-subject comparisons of arrhythmia detection for the 24-hour period during which both devices were worn. Holter monitoring detected 61 arrhythmia events, compared with 52 detected by the Zio Patch (p=0.013). This study further suggests that extended monitoring may increase the diagnostic yield of cardiac monitoring. However, a relatively large number of missed events occurred with the Zio Patch during the period of simultaneous monitoring, which may have clinical significance if its performance is similar in non-research settings. The available evidence on continuously worn cardiac monitors that can store data for longer periods of time than standard Holter monitoring indicates that such devices typically detect greater numbers of arrhythmias during extended follow-up than 24- or 48-hour Holter monitoring. However, a more appropriate comparison group for such monitors is AEMs, and evidence on this comparison is lacking. Summary Mobile cardiac outpatient telemetry (MCOT) is another option for long-term cardiac monitoring. Evidence from 1 RCT and uncontrolled case series, along with clinical input, suggests that MCOT is likely to be as effective at detecting arrhythmias as autotriggered event monitors. Although MCOT has the theoretical advantage of allowing a rapid response to a potentially emergent arrhythmia, none of the available studies have clearly shown an improvement in clinical utility as a result of using MCOT. Further studies are needed to compare MCOT with the auto-trigger loop recorder to determine whether the faster response possible with real-time monitoring leads to improved outcomes. Newer continuous monitoring devices are available that use novel technology and record information for longer periods than a Holter monitor, e.g., up to two weeks. The available evidence for these devices suggests that they typically detect greater numbers of arrhythmias during extended follow-up than 24- or 48-hour Holter monitoring. However, a more appropriate comparison group for such monitors is AEMs, and evidence on this comparison is lacking. Key Words: Mobile outpatient cardiac telemetry, MCOT, outpatient cardiac telemetry, OCT, Verite´, Zio® Patch, Zio™ ECG Utilization Service, ZEUS, VectraplexECG™, BodyGuardian Remote Monitoring System™, HeartLinkII™, VST™, LifeStar™ ACT, CardioNet®

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Medical Policy #460

Approved by Governing Bodies: A number of MCOT devices have received approval by the U.S. Food and Drug Administration including, Mobile Cardiac Outpatient Telemetry ™ (MCOT ™) (CardioNet Inc.), the HEARTLink II ™ system (Cardiac Telecom Corp.), the VST ™ (Vital Signs Transmitter, Biowatch Medical), NUVANT ™ Mobile Cardiac Telemetry (MCT) System (Corventis, Inc.,), and the LifeStar™ Ambulatory Cardiac Telemetry (ACT) system (Card Guard Scientific Survival Ltd). The Zio® Patch (iRhythm Technologies Inc., Sand Francisco, CA) received FDA 510(k) approval in May 2009. There is no specific FDA approval for the Verite´ device. According to eCardio, these devices utilize the FDA 510(k) approval for the Braemer ER900 device. Benefit Application: Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable. ITS: Home Policy provisions apply. FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity. Current Coding: Any existing or future devices for this service should be billed in accordance with the CPT-4 manual, the CPT Changes: An Insider’s View book, and the CPT Assistant intent and instructions. If the service is not consistent with these sources, the service should be billed with the not otherwise classified (NOC) code. CPT Codes:

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 (Effective 01/01/2012)

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) (Effective 01/01/2012)

0297T External electrocardiographic recording for more than 48 hours up to 21 days by continuous rhythm recording and storage; scanning analysis with report (Effective 01/01/2012)

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Medical Policy #460

0298T External electrocardiographic recording for more than 48 hours up to 21 days by continuous rhythm recording and storage; review and interpretation (Effective 01/01/2012)

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 ; 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

For hybrid devices:

93799 Unlisted cardiovascular service or procedure References: 1. Barrett PM, Komatireddy R, Haaser S, et al. Comparison of 24-hour Holter monitoring with

14-day novel adhesive patch electrocardiographic monitoring. Am J Med. Jan 2014; 127(1):95 e11-97.

2. Joshi AK, Kowey PR, Prystowsky EN et al. First experience with a Mobile Cardiac Outpatient Telemetry (MCOT) system for the diagnosis and management of cardiac arrhythmia. Am J Cardiol 2005; 95(7):878-91.

3. Kadish AH, Reiffel JA, Clauser J et al. Frequency of serious arrhythmias detected with ambulatory cardiac telemetry. Am J Cardiol 2010; 105(9):1313-6.

4. Olson JA, Fouts AM, Padanilam BJ et al. Utility of mobile cardiac outpatient telemetry for the diagnosis of palpitations, presyncope, syncope, and the assessment of therapy efficacy. J Cardiovasc Electrophysiol 2007; 18(5):473-7.

5. Rothman SA, Laughlin JC, Seltzer J et al. The diagnosis of cardiac arrhythmias: a prospective multi-center randomized study comparing mobile cardiac outpatient telemetry versus standard loop event monitoring. J Cardiovasc Electrophysiol 2007; 18(3): 241-247.

6. Saarel EV, Doratotaj S, Sterba R. Initial experience with novel mobile cardiac outpatient telemetry for children and adolescents with suspected arrhythmia. Congenit Heart Dis 2008; 3(1):33-8.

7. Tayal AH, Tian M, Kelly KM et al. Atrial fibrillation detected by mobile cardiac outpatient telemetry in cryptogenic TIA or stroke. Neurology 2008; 71(21):1696-701.

8. Turakhia MP, Hoang DD, Zimetbaum P, et al. Diagnostic utility of a novel leadless arrhythmia monitoring device. Am J Cardiol. Aug 15 2013; 112(4):520-524.

9. www1.ecardio.com/Shared/pdf/ER920W.pdf. Last accessed March 2014. 10. www1.ecardio.com/News/Article.aspx?id=8. Last accessed March 2014. 11. www.irhythmtech.com/zio-solution/zio-patch. Last accessed March 2011. 12. www.irhythmtech.com/company/milestones/. Last accessed December 2011.

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Medical Policy #460

Policy History: Medical Policy Group, March 2011 (2) Medical Review Committee, March 2011 Medical Policy Administration Committee, March 2011 Medical Policy Group, May 2011 (2) Medical Policy Administration Committee, June 2011 Available for comment June 8 – July 25, 2011 Medical Policy Group, December 2011 (2): Description and References updated Medical Policy Group, December 2011 (3): Added 2012 ‘T’ codes effective January 1, 2012 Medical Policy Group, December 2012 (3): 2013 Coding Update: Verbiage change to Codes 93228 & 93229-added “by a physician or other qualified health care professional”. Effective 01/01/2013. Medical Policy Group, March 2014 (3): Update to Description, Key Points, Key Words, Governing Bodies, & References with available equipment Verite´ by eCardio Medical Policy Panel, November 2014 Medical Policy Group, January 2015 (3): 2014 Updates to Description, Key Points, Key Words, Governing Bodies & References; no change in policy statement; status remains unchanged This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case- by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment. This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.