Medical Policy: 02.02.11
Original Effective Date: April 2006
Reviewed: May 2017
Revised: May 2017
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
The intended use of all ambulatory cardiac monitors are for diagnosis of cardiac arrhythmias. There is only one indication, atrial fibrillation, where the monitors would be considered after arrhythmia diagnosis. This indication would only be applicable for self-activated or auto-activated external ambulatory event monitors and not long term monitoring.
Ambulatory Holter electrocardiography (EKG) is a widely used noninvasive test in which the EKG is continuously recorded over an extended period of time, typically 24 to 48 hours, to evaluate symptoms suggestive of cardiac arrhythmias, e.g., palpitations, dizziness, or syncope. However, Holter monitoring will be ineffective in detecting arrhythmias if a patient experiences infrequent symptoms.
The Zio Patch (iRhythm Technologies, Inc., San Francisco, CA) is a recording device that provides continuous single-lead ECG data for up to 14 days (Mittal et al, 2011). The Zio Patch uses a patch that is placed on the left pectoral region. The patch does not require patient activation. However, a button on the patch can be pressed by the patient to mark a symptomatic episode. At the end of the recording period, the patient mails back the recorder in a prepaid envolope to a central monitoring station (Mittal et al, 2011). A report is provided to the ordering physician within a few days. The manufacturer states that it is indicated for use in patients who may be asymptomatic or who may suffer from transient symptoms (e.g., anxiety, dizziness, fatigue, light-headedness, palpitations, pre-syncope, shortness of breath, and syncope). The Zio ECG Utilization Service (ZEUS) system is a comprehensive system that processes and analyzes received ECG data captured by long-duration, single-lead, continuous recording diagnostic devices.
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.
Ambulatory event monitors (AEMs) were developed to provide longer periods of monitoring. In this technique the recording device is either worn continuously or activated only when the patient experiences symptoms or is carried by the patient and applied and activated when symptoms are present. The recorded EKGs are then stored for future analysis or transmitted by telephone to a receiving station, such as a doctor's office, hospital, or cardiac monitoring service, where the EKGs can then be analyzed. AEMs can be used for extended periods of time, typically up to a month until the patient experiences symptoms.
Several different types of Ambulatory Event Monitors are available. These are available in self-activated and auto-activated models:
These devices are carried by the patient and applied to the precordial area via non-gel 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 and the REKA E100)
These sophisticated devices are able to continuously store a single channel of EKG data in a refreshed memory. If the patient activates the device, the EKG 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 or other transient events. These devices are worn continuously.
For patients with very infrequent cardiac events requiring long term monitoring, 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. More recently, auto-triggering 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. The Reveal® Insertable Loop Recorder is an implantable memory loop device approved by the U.S. Food and Drug Administration (FDA). In February 2014, the FDA cleared for marketing the Reveal LINQ™, a miniaturized implantable memory loop device that is auto-triggered or patient-activated rhythm recording.
Real-time outpatient cardiac telemetry, also known as real-time remote heart monitors, and mobile cardiac outpatient telemetry, are devices that integrate standard AEM devices with automated calling features using computer activated dialing of telephone land lines or cellular communication technology and monitoring services. As with standard AEMs, real-time remote heart monitors use similar types of EKG leads and recording devices. However, when a real-time remote heart monitor detects an arrhythmia, either automatically or by the patient himself, the EKG record is transmitted to a service center, which may notify the treating physician if certain criteria are met.
There are several real-time remote heart monitors available on the market in the U.S. The CardioNet Mobile Cardiac Outpatient Telemetry Service™ (MCOT™) uses the CardioNet monitoring device, Telemetry @ Home uses the HEARTLink II™ monitoring device, Lifewatch® utilizes the Lifestar ACT (Ambulatory Cardiac Telemetry) device, Applied Cardiac Systems, Inc (ACS) uses the Core device, and Biowatch™ uses the Vital Signs Transmitter (VST™).
The VectraplexECG™ System is a real-time continuous Mobile Cardiac Outpatient Telemetry device to measure ischemic ECG changes that can be indicative of a myocardial infarction (MI). This device utilizes the Internet to communicate real-time ECG changes to the physician. TeleSense remote cardiac monitor uses wifi to transmit real-time data.
In 2014, the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Rhythm Society issued guidelines on the management of patients with atrial fibrillation (AF). These guidelines recommend the use of Holter or event monitoring if the diagnosis of the type of arrhythmia is in question or as a means of evaluating rate control. Note that there is no recommendation for long-term or real-time monitoring.
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 patients who experience symptoms that are suggestive of cardiac arrhythmias (syncope and presyncope) less frequently than every 48 hours. They should be used for diagnosing heart arrhythmias and not monitoring known arrhythmias, except as noted for atrial fibrillation below.
The use of patient-activated or auto-activated external ambulatory event monitors may be considered medically necessary in patients with atrial fibrillation:
The use of patient-activated or auto-activated external ambulatory event monitors may be considered medically necessary in patients with cryptogenic stroke after a non-diagnostic Holter monitor. (93268, 93270, 93271, 93272)
The use of implantable ambulatory event monitors, either patient activated or auto-activated, may be considered medically necessary only in the small subset of patients who experience recurrent symptoms of syncope or presyncope so infrequently that a prior trial of Holter monitor and other external ambulatory event monitors has been unsuccessful. They should only be used for diagnosis and not monitoring of arrhythmias. It would be the expectation that a previous trial of ambulatory monitoring has been non-diagnostic and symptoms persist. (33282, 33284, E0616)
Contraindications for the use of implantable ambulatory include:
Other uses of all ambulatory monitors are considered not medically necessary, including but not limited to, detection of myocardial ischemia by identifying ST segment changes, measurement of heart rate variability in the assessment of a patient at risk for future cardiac events without symptoms of arrhythmia and ongoing management of diagnosed arrhythmias.
Real-time outpatient cardiac telemetry devices may be considered medically necessary for a narrow subset of patients when ALL of the following are met:
Real-time outpatient cardiac telemetry devices are not intended for monitoring patients with life-threatening arrhythmias.
Use of real-time outpatient cardiac telemetry devices is considered not medically necessary outside the criteria listed above. This includes, but is not limited to, ongoing management after diagnosis, medication management or asymptomatic patients.
Continuous ambulatory monitors that record and store information for longer than 48 hours (Zio Patch and BodyGuardian) (0295T, 0296T, 0297T, 0298T) are considered not medically necessary.
The current literature fails to compare longer recording monitors (Zio Patch and BodyGuardian) to monitors with an equivalent monitoring timeframe. There is not strong evidence to suggest that long-term continuous monitors are superior to external loop recorders in detecting arrhythmias. The current literature compares long-term monitors to Holter monitors which does not accurately reflect the population the monitors would be used for. The current guidelines (AHA/ACC/HRS and NICE) suggest long term continuous monitoring can be an alternative to other monitoring but fail to determine superiority in the population utilizing long term recording. Ambulatory cardiac event monitors, either patient activated or auto activated, remain the most cost-effective in detecting arrhythmias that occur at least every 30 days.
The diagnostic yield for ambulatory event monitors and mobile cardiac outpatient telemetry is equivalent. It would be the expectation that the most appropriate monitor for the patient be selected.
Given the small but higher risk associated with an implantable device, it would be reasonable to consider the use of an implantable loop recorder after a trial of an external monitor does not yield a definitive diagnosis.
The clinical outcomes of extended cardiac monitoring for longer than 48 hours have not been shown to be superior to other available approaches, including other ambulatory evernt monitors. Therefore, the use of these devices is considered not medically necessary for all indications.
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