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Ambulatory Event Monitors and Mobile Cardiac Outpatient Telemetry Protocol (20208) Medical Benefit Preauthorization No Effective Date: 07/01/16 Next Review Date: 05/17 Review Dates: 05/07, 07/08, 09/09, 09/10, 01/11, 01/12, 01/13, 01/14, 09/14, 05/15, 05/16 This Protocol considers mobile cardiac outpatient telemetry investigational. If the physician feels this service is medically necessary, preauthorization is recommended. The following Protocol contains medical necessity criteria that apply for this service. The criteria are also applicable to services provided in the local Medicare Advantage operating area for those members, unless separate Medicare Advantage criteria are indicated. If the criteria are not met, reimbursement will be denied and the patient cannot be billed. Please note that payment for covered services is subject to eligibility and the limitations noted in the patient’s contract at the time the services are rendered. Populations Patients/individuals with: • Symptoms suggestive of arrhythmia Patients/individuals with: • Symptoms suggestive of arrhythmia Patients/individuals with: • Symptoms suggestive of arrhythmia Interventions Interventions of interest are: • Patient-activated or autoactivated external AEMs Interventions of interest are: • Outpatient cardiac telemetry Patients/individuals with: • AF following ablation Interventions of interest are: • Patient-activated or autoactivated external AEMs • Outpatient cardiac telemetry • CAMs storing information greater than 48 h Interventions of interest are: • Patient-activated or autoactivated external AEMs • Outpatient cardiac telemetry • CAMs storing information greater than 48 h • Patient-activated or autoactivated implantable AEMs Interventions of interest are: • Patient-activated or autoactivated implantable AEMs Patients/individuals with: • Cryptogenic stroke with negative standard workup for AF Patients/individuals with: • Symptoms suggestive of arrhythmia with infrequent symptoms Interventions of interest are: • CAMs storing information greater than 48 h Comparators Comparators of interest are: • ECG only or 24-48 h Holter monitoring Comparators of interest are: • Patient-activated or autoactivated external AEMs Comparators of interest are: • 24-48 h Holter monitoring • Patient-activated or autoactivated external AEMs Comparators of interest are: • Management with 24-48 h Holter monitoring Outcomes Relevant outcomes include: • Overall survival • Morbid events Relevant outcomes include: • Overall survival • Morbid events Relevant outcomes include: • Overall survival • Morbid events Comparators of interest are: • Standard evaluation for stroke, including ECG and 24-h Holter monitor Relevant outcomes include: • Overall survival • Medication use • Treatment-related morbidity • Morbid events Comparators of interest are: • No additional evaluation/ standard care • Management with patientactivated or auto-activated external AEMs Relevant outcomes include: • Overall survival • Treatment-related morbidity • Morbid events Relevant outcomes include: • Medication use • Morbid events Page 1 of 11 Protocol Ambulatory Event Monitors and Mobile Cardiac Outpatient Telemetry Populations Patients/individuals with: • Risk factors for AF Interventions Interventions of interest are: • CAMs storing information greater than 48 h Comparators Comparators of interest are: • No additional evaluation/ standard care Last Review Date: 05/16 Outcomes Relevant outcomes include: • Overall survival • Medication use • Morbid events AEM: ambulatory event monitor; AF: atrial fibrillation; CAM: continuous ambulatory monitor; ECG: electrocardiogram. Description There are a wide variety of devices available for outpatient cardiac rhythm monitoring. The primary purpose of these devices is the evaluation of suspected arrhythmias that have not been detected by office- or hospitalbased monitoring. These devices differ in the types of monitoring leads used, the duration and continuity of monitoring, the ability to detect arrhythmias without patient intervention, and the mechanism of delivery of the information from patient to clinician. These devices may be used for the evaluation of symptoms suggestive of arrhythmias, such as syncope or palpitations, but also may be used in the detection of atrial fibrillation (AF) in patients who have undergone cardiac ablation of AF or who have a history of cryptogenic stroke. Summary of Evidence For the use of autoactivated event monitors for arrhythmia detection in patients with suspected arrhythmias, a number of studies have indicated that autotrigger event monitors detect additional episodes of arrhythmias compared with Holter monitoring or patient-triggered devices. This evidence has led to the acceptance of autotrigger event monitors as the criterion standard for detecting arrhythmias that occur infrequently. For the use of autoactivated event monitors for detection of atrial fibrillation (AF) in patients who have been treated with catheter ablation, there is evidence that autotrigger devices can pick up asymptomatic episodes of AF in patients treated with catheter ablation and that identifying asymptomatic episodes may lead to modifications in treatment. For the use of autoactivated event monitors for the detection of AF in patients with cryptogenic stroke, the most direct evidence consists of one well-designed and well-controlled randomized controlled trial (RCT) which demonstrated improved AF detection rates for patients managed with 30 days of autotriggered event monitoring compared with those managed with 24-hour Holter monitoring. Observational studies support this finding. There are recognized management changes which lead to improved outcomes for patients with stroke and AF (i.e., initiation of oral anticoagulation). Therefore, the published evidence is sufficient to determine that autotrigger event monitors improve the net health outcome for patients with suspected arrhythmia, for patients who have undergone catheter ablation for AF and in whom discontinuation of systemic anticoagulation is being considered, and for patients with cryptogenic stroke. Similarly, for the use of implantable event monitors for the detection of AF in patients with cryptogenic stroke, the most direct evidence consists of an RCT comparing the use of an autotriggered implantable monitor with routine care in patients with cryptogenic stroke. This study demonstrated improvements in AF detection rate with event monitoring, compared with routine care. The published evidence is sufficient to determine that implantable event monitors for AF detection improve the net health outcome for patients with cryptogenic stroke. For the evaluation of patients with infrequent symptoms who have not had arrhythmias detected with standard Holter monitoring or external event monitors, there is little direct evidence regarding outcomes associated with implantable loop recorders. Implantable loop recording devices likely have greater sensitivity in detecting arrhythmias in patients presenting with symptoms suggestive of arrhythmia. The available evidence does not Page 2 of 11 Protocol Ambulatory Event Monitors and Mobile Cardiac Outpatient Telemetry Last Review Date: 05/16 clearly define the indications for an implantable loop recorder; however, given the small but higher risk associated with an implantable device, for patients presenting with signs or symptoms suggestive of an arrhythmia, it would be reasonable to consider the use of an implantable loop recorder after a trial of an external loop recorder does not yield a definitive diagnosis. 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 consists of crosssectional studies that show they typically detect greater numbers of arrhythmias during extended follow-up than 24- or 48-hour Holter monitoring. However, the appropriate comparison group would be patient- or autotriggered event monitors, and no studies were identified that compared longer recording devices with patientor autotriggered event monitors. Direct evidence for improved outcomes with the use of these types of monitors is lacking. The evidence for a significant incremental improvement in outcomes when continuous monitoring devices are used is lacking. Therefore, the available published evidence is considered insufficient to determine that continuous monitoring devices with longer recording periods improve the net health outcome for patients with suspected arrhythmias. Mobile cardiac outpatient telemetry (MCOT) is another option for long-term cardiac monitoring. For the use of MCOT for the evaluation of patients with suspected arrhythmias, evidence from one RCT and uncontrolled case series 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 autotrigger loop recorder to determine whether the faster response possible with real-time monitoring leads to improved outcomes. Direct evidence for improved health outcomes with the use of MCOT for the evaluation of suspected arrhythmias is lacking, and evidence for a significant incremental improvement in outcomes with MCOT, compared with standard management, is lacking. Therefore, the available published evidence is considered insufficient to determine that MCOT improves the net health outcome for patients with suspected arrhythmias. Similarly, for the use of MCOT for the detection of AF either in patients following catheter ablation of AF or following cryptogenic stroke, there is no direct evidence comparing MCOT with other detection methods. Singlearm studies report relatively high rates of AF detection with MCOT in patients with cryptogenic stroke. Direct evidence for improved health outcomes with the use of MCOT for the evaluation of AF and evidence for a significant incremental improvement in outcomes with MCOT, compared with standard management, is lacking. Therefore, the available published evidence is considered insufficient to determine that MCOT improves the net health outcome for patients who require evaluation for AF. Policy The use of patient activated or auto-activated external ambulatory event monitors may be considered medically necessary as a diagnostic alternative to Holter monitoring in the following situations: • Patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of cardiac arrhythmias (i.e., palpitations, dizziness, presyncope, or syncope). • Patients with atrial fibrillation who have been treated with catheter ablation, and in whom discontinuation of systemic anticoagulation is being considered. • Patients with cryptogenic stroke who have a negative standard work-up for atrial fibrillation including a 24hour Holter monitor (see Policy Guidelines). Page 3 of 11 Protocol Ambulatory Event Monitors and Mobile Cardiac Outpatient Telemetry Last Review Date: 05/16 The use of implantable ambulatory event monitors, either patient activated or auto-activated, may be considered medically necessary in the following situations: • In the small subset of patients who experience recurrent symptoms so infrequently that a prior trial of other external ambulatory event monitors has been unsuccessful. • In patients with cryptogenic stroke who have had a negative standard work-up for atrial fibrillation including a 24-hour Holter monitor (see Policy Guidelines). The use of outpatient cardiac telemetry (also known as mobile cardiac outpatient telemetry [MCOT]) as a diagnostic alternative to ambulatory event monitors in patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of cardiac arrhythmias (i.e., palpitations, dizziness, presyncope, or syncope) is considered investigational. The use of continuous ambulatory monitors that record and store information for periods longer than 48 hours may be considered medically necessary as a diagnostic alternative to Holter monitoring or patient-activated or auto-activated external ambulatory event monitors in the following situations: • Patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of cardiac arrhythmias (i.e., palpitations, dizziness, presyncope, or syncope). • Patients with atrial fibrillation who have been treated with catheter ablation, and in whom discontinuation of systemic anticoagulation is being considered. • Patients with cryptogenic stroke who have a negative standard work-up for atrial fibrillation including a 24hour Holter monitor (see Policy Guidelines). Other uses of ambulatory event monitors, including outpatient cardiac telemetry, are considered investigational, including but not limited to monitoring effectiveness of antiarrhythmic medications and detection of myocardial ischemia by detecting ST segment changes. Policy Guidelines For the evaluation of patients with cryptogenic stroke who have had a negative standard work-up for atrial fibrillation including 24-hour Holter monitoring, the use of long-term monitoring with an external event monitor, OR a continuous ambulatory monitor that records and stores information for periods longer than 48 hours, OR an implantable ambulatory monitor may be considered medically necessary for patients who meet the criteria outlined above. Medicare Advantage Except for this additional medically necessary statement, the above policy statements and guidelines apply for Medicare Advantage. Telephonic EKG transmissions are considered medically necessary as a diagnostic service for the indications below: 1. Detection, characterization, and documentation of symptomatic transient arrhythmias; 2. Initiate, revise, or discontinue arrhythmic drug therapy; or, 3. Carry-out early post-hospital monitoring of patients discharged after myocardial infarction (MI); (only if 24hour coverage is provided). Page 4 of 11 Protocol Ambulatory Event Monitors and Mobile Cardiac Outpatient Telemetry Last Review Date: 05/16 24-hour attended coverage used as early post-hospital monitoring of patients discharged after MI is only covered if provision is made for such 24-hour attended coverage in the manner described below: 24-hour attended coverage means there must be, at a monitoring site or central data center, an EKG technician or other non-physician, receiving calls and/or EKG data; tape recording devices do not meet this requirement. Further, such technicians should have immediate, 24-hour access to a physician to review transmitted data and make clinical decisions regarding the patient. The technician should also be instructed as to when and how to contact available facilities to assist the patient in case of emergencies. Background A variety of cardiac monitors are available for the evaluation of patients with potential arrhythmias. Signs and symptoms potentially suggestive of arrhythmias include palpitations, dizziness, syncope, or presyncope, or abnormal heart rate or rhythm noted on exam. In addition, because of the association between atrial fibrillation (AF) and stroke or transient ischemic attack (TIA), monitoring for asymptomatic AF is often part of the evaluation for the cause of a stroke or TIA. A brief description of the major categories of devices is given next. There has been a trend in recent years toward using novel technology to increase the efficiency, comfort, and convenience of these devices. These technologic advances include the development of devices that are smaller and more convenient to use, as well as novel ways to rapidly transmit information, such as by use of mobile devices. These advances in technology may present challenges in categorizing new devices. Some of the newer devices are described next for informational purposes in assigning them to the most relevant category. However, because there may be many devices within each category, a comprehensive description of individual devices is beyond the scope of this review. Continuous Monitoring Devices (Holter Monitors and Similar Devices) Ambulatory Holter electrocardiography (ECG) is a widely used noninvasive test in which ECG is continuously recorded over an extended period of time, typically 24 to 48 hours, to evaluate symptoms suggestive of cardiac arrhythmias (i.e., palpitations, dizziness, syncope). However, Holter monitoring will be ineffective in detecting arrhythmias if a patient experiences infrequent symptoms. Therefore, the sensitivity of Holter monitoring is low for detection of arrhythmias that are intermittent. Continuous Monitoring Devices With Longer Recording Periods Some newer devices are continuous monitors that 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, 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. • The BodyGuardian Remote Monitoring System™ (Preventice®, 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. Page 5 of 11 Protocol Ambulatory Event Monitors and Mobile Cardiac Outpatient Telemetry Last Review Date: 05/16 Noncontinuous Monitoring Devices (AEMs and Similar Devices) Ambulatory event monitors (AEMs) were developed to provide longer periods of monitoring by using noncontinuous monitoring. In this technique, the recording device is either worn continuously and activated only when the patient experiences symptoms or is carried by the patient and applied and activated when symptoms are present. The recorded ECGs are then stored for future analysis or transmitted by telephone to a receiving station (e.g., a doctor’s office; hospital; cardiac monitoring service) where the ECGs can then be analyzed. AEMs can be used for extended periods of time, typically up to one month or until the patient experiences symptoms. Because the ECGs are recorded only during symptoms, there is good correlation with any underlying arrhythmia. Conversely, if no ECG abnormality is noted, a noncardiac etiology of the patient’s symptoms can be sought. Several different types of AEMs are available: Noncontinuous Devices With Memory These devices are carried by the patient and applied to the precordial area via nongel electrodes when the symptoms are occurring or, alternatively, a recording device may be worn on the wrist and then activated when symptoms are present. The limitation of these devices is that an arrhythmia of very short duration would be difficult to record. In addition, noncontinuous devices require reasonable dexterity on the part of the patient to apply the device correctly during a symptomatic period. This is a particular limitation if the patient is incapacitated during symptomatic periods. • The Zio® Event Card (iRhythm Technologies, San Francisco, CA) is a noncontinuous real-time recording device that can be worn up to 30 days. This device can be worn comfortably under clothing (including during sleep), as it weighs less than two ounces and is similar in size to a standard credit card. On activation by the patient, the card is able to record the previous 45 seconds of ECG activity into memory plus the first 15 seconds after the button is pushed. This is made possible because this device continuously scans for ECG activity but only records on symptom activation. After the device is activated, the patient is responsible for calling the iRhythm National Clinical Center, which then instructs the patient on sending the event over the phone line. • The REKA E100™ system is a noncontinuous single-lead cardiac event monitor. This device is the size of a hockey puck and weighs no more than a few ounces. There are two options, depending on the patient’s circulation: (1) a zero-lead device that is separate from the body and may be carried in a purse or coat pocket; or if a patient’s circulation is determined to be inadequate, (2) a single electrode lead that the patient connects to the device at the time of an event. The zero-lead device records an event by patient activation and can record and store up to 2000 readings. Patients have the option of sending stored event information to the physician across a free-of-charge phone app or the Internet in their computer. Internet transmission requires one of the following systems: Android, Blackberry, iPhone 3, 3S, 4, and 4S, iPad, iPod Touch®, Microsoft, or Windows. Continuous “Memory Loop” Devices These devices are able to continuously store a single channel of ECG data in a refreshed memory. If the patient activates the device, the ECG is then recorded from the memory loop for the preceding 30 to 90 seconds and for the next minute or so. Therefore, these types of devices permit recording of the onset of arrhythmias and/or transient or incapacitating events. They obviously must be worn continuously. Implantable Continuous “Memory Loop” Devices An implantable loop recorder device is inserted just under the patient’s skin in the chest area during an outpatient surgical procedure. When symptoms are felt, the patient places a hand-held activator over the recorder to activate the storage of cardiac rhythms. This device can be used for more than one year. Page 6 of 11 Protocol Ambulatory Event Monitors and Mobile Cardiac Outpatient Telemetry Last Review Date: 05/16 Autotrigger Devices All of the previously described devices require activation by the patient. More recently, autotriggering technology has become available, which can be adapted to memory loop devices. For example, event monitors can be programmed to detect heart rates greater than 165 beats per minute, less than 40 beats per minute, or an asystole of greater than three seconds. Implantable Continuous “Memory Loop” Devices With Autotrigger These devices combine the long-term monitoring available with implantable devices with the autotriggers seen on newer event monitors. These devices contain algorithms that are programmed to detect heart rates exceeding an upper or lower limit, asystole of greater than three seconds. They typically contain other autotriggers, such as a variable RR interval seen with AF. For example, the Reveal® XT ICM (Medtronic, Minneapolis, MN) is an implantable memory loop device cleared for marketing by the U.S. Food and Drug Administration (FDA) in 2008 that allows patient-activated rhythm recording, rhythm recording at prespecified time intervals, or autotriggered rhythm recording. Sizes of implantable devices are decreasing: in February 2014, FDA cleared for marketing the Reveal LINQ™, a miniaturized implantable memory loop device that is approximately 1 mL that includes autotriggered or patient-activated rhythm recording. Mobile Cardiac Outpatient Telemetry AEMs store the recorded data, which are ultimately transmitted either to a physician’s office or to a central recording station. In contrast, outpatient cardiac telemetry provides real-time monitoring and analysis. For example, CardioNet® now owned by BioTelemetry (Malvern, PA), offers 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. When an arrhythmia is detected according to preset parameters, the ECG is automatically transmitted to a central CardioNet service center, where the ECG is immediately interpreted, with results sent to the referring physician. 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), the Vital Signs Transmitter (VST™; Biowatch Medical, Columbia, SC), the LifeStar™ Ambulatory Cardiac Telemetry (ACT) system (Card Guard Scientific Survival, Israel), and the SEEQ™ Mobile Cardiac Telemetry System (Medtronic, Minneapolis, MN). The eCardio Verité™ system (eCardio, Houston, TX) is a multifunctional model that can be changed between a patient-activated event monitor and a continuous telemetry monitor. The VectraplexECG™ System is a real-time continuous MCOT device to measure ischemic ECG changes that can be indicative of a myocardial infarction. 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. Regulatory Status Some of the newer devices are described in the Background section for informational purposes. However, because there may be many devices within each category, a comprehensive description of individual devices is beyond the scope of this review. Page 7 of 11 Protocol Ambulatory Event Monitors and Mobile Cardiac Outpatient Telemetry Last Review Date: 05/16 Services that are the subject of a clinical trial do not meet our Technology Assessment Protocol criteria and are considered investigational. For explanation of experimental and investigational, please refer to the Technology Assessment Protocol. It is expected that only appropriate and medically necessary services will be rendered. We reserve the right to conduct prepayment and postpayment reviews to assess the medical appropriateness of the above-referenced procedures. Some of this Protocol may not pertain to the patients you provide care to, as it may relate to products that are not available in your geographic area. References We are not responsible for the continuing viability of web site addresses that may be listed in any references below. 1. DiMarco JP, Philbrick JT. Use of ambulatory electrocardiographic (Holter) monitoring. Ann Intern Med. Jul 1 1990; 113(1):53-68. PMID 2190517 2. Hoefman E, Bindels PJ, van Weert HC. Efficacy of diagnostic tools for detecting cardiac arrhythmias: systematic literature search. Neth Heart J. Nov 2010; 18(11):543-551. PMID 21113379 3. 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. PMID 23672988 4. Barrett PM, Komatireddy R, Haaser S, et al. 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