Commercial

Medical Policy

Title:

Ambulatory Electrocardiography (AECG) Monitoring and Mobile Cardiac Outpatient Telemetry (MCOT) Monitoring

Policy #:

07.02.21p

Policy

AMBULATORY ELECTROCARDIOGRAPHY (AECG) MONITORING, INCLUDING MOBILE CARDIAC OUTPATIENT TELEMETRY (MCOT) MONITORING

Any of the following clinical criteria for AECG monitoring, including MCOT monitoring, must be met to be considered medically necessary and, therefore, covered. In addition, the monitoring device's criteria listed below must also be met to be considered medically necessary and, therefore, covered.

MEDICALLY NECESSARY CLINICAL CRITERIA

Adult Clinical Criteria

AECG monitoring, including MCOT monitoring, is considered medically necessary and, therefore, covered under any of the following circumstances:

To establish the diagnosis for recurrent symptoms/conditions related to arrhythmia, such as presyncope, syncope, palpitations, shortness of breath, chest pain, or dizziness, that are less frequent than once every 48 hours, when the diagnosis has not been determined by indicated diagnostic work-up (e.g., complete clinical history and physical examination, standard 12-lead electrocardiography [ECG], cardiac imaging)
- The ordering professional provider must document the prior testing performed and the results
To assess documented or suspected bradycardia
For individuals experiencing nocturnal arrhythmias
To monitor individuals who have had surgical or catheter ablation of atrial fibrillation (AF) when discontinuation of systemic anticoagulation is being considered
To monitor individuals with cryptogenic stroke who have a negative work-up for AF when the etiology of the symptoms/conditions of arrhythmia has not been determined after indicated diagnostic work-up (e.g., a complete clinical history and physical examination, standard 12-lead echocardiography [ECG], cardiac imaging)
To assess the average heart rate and adequacy of rate control in an individual with AF
To assess the effectiveness of arrhythmia therapy (e.g., postablation) and/or aid in the regulation of antiarrhythmic drug dosages
To assess function of pacemakers or implantable cardioverter defibrillators (ICD) in order to evaluate any of the following:
- Frequent symptoms of palpitation, syncope, or near syncope to assess device function to exclude myopotential inhibition and pacemaker-mediated tachycardia
- Frequent symptoms of palpitation, syncope, or near syncope to assist in programming parameters such as rate-responsivity and automatic mode switching
- Suspected component failure or malfunction when device interrogation is not definitive in establishing a diagnosis
- Response to adjunctive pharmacologic therapy in individuals receiving frequent ICD therapy
To evaluate individuals with hypertrophic, dilated or restrictive cardiomyopathies, arrhythmogenic right ventricular cardiomyopathy, long QT syndrome, congenital heart disease, or Brugada syndrome to detect arrhythmias
To evaluate individuals for silent myocardial ischemia with known or suspected coronary artery disease
To evaluate prognosis following acute coronary syndrome

Pediatric Clinical Criteria

In accordance with the American College of Cardiology/American Heart Association, pediatric AECG monitoring, including MCOT monitoring, is considered medically necessary and, therefore, covered for the evaluation of the following indications:

Syncope, near syncope, or dizziness with recognized heart disease, previously documented arrhythmia, or pacemaker dependency
Syncope or near syncope associated with exertion when the cause is not established by other methods
Hypertrophic or dilated cardiac myopathies
Possible or documented long QT syndromes
Palpitations in individuals with prior surgery for congenital heart disease and significant residual hemodynamic abnormalities
Antiarrhythmic drug efficacy
Asymptomatic congenital atrioventricular (AV) block, nonpaced

MEDICALLY NECESSARY MONITORING DEVICE CRITERIA
Monitoring Device Criteria (Adults and Pediatrics)

Continuous AECG monitoring (24- or 48-hour Holter monitoring) is considered medically necessary and, therefore, covered for either of the following indications:

Results of this testing will provide diagnostic and/or treatment information useful in the ongoing management of the individual about and beyond that provided by standard 12-lead ECG.
- The ordering professional provider must document the prior testing performed and the results.
Standard 12-lead ECG is documented in the medical record to be unlikely to capture and record an arrhythmia.

External cardiac event detection monitoring (e.g., external loop monitoring) is considered medically necessary and, therefore, covered for either of the following indications:

Results of this testing will provide diagnostic and/or treatment information useful in the ongoing management of the individual about and beyond that provided by continuous 24- or 48-hour Holter monitoring.
- The ordering professional provider must document the prior testing performed and the results.
Continuous 24- or 48-hour Holter monitoring is documented in the medical record to be unlikely to capture and record an arrhythmia.

External cardiac event detection monitoring must be attended 24 hours a day, 7 days a week.

External cardiac event detection monitoring devices that are patient activated are not indicated for individuals who are unresponsive, comatose, severely confused, or otherwise unable to recognize symptoms or activate the recorder device.

Symptomatic transient cardiac arrhythmias are typically detected within 2 months of external cardiac event detection monitoring. However, an extended period of monitoring may be considered for coverage by the Company in certain circumstances (i.e., efficacy of newly introduced antiarrhythmic medications, efficacy of cardiac medications postablation, severe symptoms of arrhythmia, and cryptogenic stroke).

Continuous AECG monitoring for periods greater than every 48 hours (e.g., Zio® Patch) is considered medically necessary and, therefore, covered for either of the following indications:

Results of this testing will provide diagnostic and/or treatment information useful in the ongoing management of the individual about and beyond that provided by continuous 24- or 48-hour Holter monitoring and/or external cardiac event detection monitoring (e.g., external loop monitoring).
- The ordering professional provider must document the prior testing performed and the results.
Continuous 24- or 48-hour Holter monitoring and/or external cardiac event detection monitoring (e.g., external loop monitoring) is documented in the medical record to be unlikely to capture and record an arrhythmia.

Mobile cardiac outpatient telemetry monitoring of non–life-threatening arrhythmias for up to two episodes of up to 30 consecutive days in a 12-month period is considered medically necessary and, therefore, covered for either of the following indications:

Results of this testing will provide diagnostic and/or treatment information useful in the ongoing management of the individual about and beyond that provided by continuous 24- or 48-hour Holter monitoring and/or external cardiac event detection monitoring (e.g., external loop monitoring).
- The ordering professional provider must document the prior testing performed and the results
Continuous 24- or 48-hour Holter monitoring and/or external cardiac event detection monitoring (e.g., external loop monitoring) is documented in the medical record to be unlikely to capture and record an arrhythmia

Cardiac event detection monitoring (implantable loop monitoring) is considered medically necessary and, therefore, covered for either of the following indications:

Results of this testing will provide diagnostic and/or treatment information useful in the ongoing management of the individual about and beyond that provided by continuous 24- or 48-hour Holter monitoring and/or external cardiac event detection monitoring (external loop monitoring)
- The ordering professional provider must document the prior testing performed and the results
Continuous 24- or 48-hour Holter monitoring and/or external cardiac event detection monitoring (external loop monitoring) is documented in the medical record to be unlikely to capture and record an arrhythmia

Note: A 24- or 48-hour Holter monitor is most appropriate for individuals with daily or near-daily symptoms. Otherwise, professional providers should order the most appropriate type of monitoring device based on their evaluation of the individual, the individual's symptoms, and the devices' labeled indications. The duration of monitoring should be consistent with the individual's signs and symptoms.

NOT MEDICALLY NECESSARY

All other uses of AECG monitoring, including MCOT monitoring, are considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the treatment of illness or injury.

EXPERIMENTAL/INVESTIGATIONAL

The use of AECG monitoring managed through a mobile application for smartphones (e.g., AliveCor, KardiaMobile) and smartwatches, is considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

When the etiology of the symptoms/conditions of arrhythmia has not been determined after a 24- or 48-hour continuous Holter monitoring or other appropriate AECG monitoring including MCOT monitoring, the ordering professional provider must document the prior testing performed and the results.

ELIGIBLE FOR REIMBURSEMENT

TECHNICAL AND PROFESSIONAL
AECG Monitoring, Including MCOT Monitoring

The professional component for AECG monitoring, including MCOT monitoring, is for the review and interpretation with report by a professional provider. When a technician, who is employed by the professional provider, retrieves and reviews data from a secure server via modem, the service is included in the reimbursement for the professional component.

External Loop Monitoring and MCOT Monitoring

The technical component (e.g., technical support for connection, individual instructions for use, remote data acquisition, technical analysis and transmission of daily and emergent data reports as prescribed by the professional provider) for external loop monitoring and MCOT monitoring is only reimbursable to the monitoring center or independent diagnostic testing facility that is gathering and transmitting the data to the professional provider for review.

Implantable Loop Monitoring

For implantable loop monitoring, the technical component is only reimbursable to an independent diagnostic testing facility that is gathering and transmitting data to professional provider for review.

EXTERNAL CARDIAC EVENT DETECTION MONITORING, MCOT MONITORING, AND IMPLANTABLE LOOP MONITORING
Reimbursement for external cardiac event detection monitoring, MCOT monitoring, and implantable loop monitoring, electronic analysis (e.g., the retrieval, viewing, printing, and saving of an ECG associated with a patient-activated syncopal event) of the data is allowed once in a 30-day period, regardless of the number of events or recordings that occur during this time frame.

NOT ELIGIBLE FOR REIMBURSEMENT

AMBULATORY ELECTROCARDIOGRAPHY MONITORING, INCLUDING MCOT MONITORING
The use of multiple forms of AECG including MCOT monitoring provided to the same individual on the same day is not eligible for coverage or reimbursement by the Company.

BILLING REQUIREMENTS

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

Guidelines

The use of ambulatory electrocardiography (AECG) monitoring, including mobile cardiac outpatient telemetry (MCOT) monitoring devices, to diagnose and treat suspected arrhythmia should not be substituted for more conventional methods of diagnosis, such as a clinical history, physical examination, and standard electrocardiogram (ECG) and rhythm strip.

Ambulatory electrocardiography monitoring, including MCOT monitoring, should only be reported for individuals being evaluated as outpatients and not used for review and interpretation of ECG rhythm strips generated by inpatient cardiac monitors or telemetry. It should not be reported for individuals in hospitals, emergency rooms, skilled nursing facilities, or other specialized facilities.

Providers of monitoring centers should be capable of receiving and recording transmissions 24 hours a day, 365 days a year while the individual is wearing the device. This includes receipt of the ECG signal, as well as a voice transmission that relates any associated symptoms. The transmission should be received by a technician, nurse, or physician trained in the interpretation of ECGs and abnormal rhythms. A professional provider should be available for immediate consultation 24 hours a day to review the transmission in case of significant symptoms or ECG abnormalities. Monitoring centers should also be capable of notifying an individual's attending professional provider immediately, when indicated.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, AECG monitoring, including MCOT monitoring, is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA for AECG monitoring, including MCOT monitoring.

Description

There are a wide variety of devices available for ambulatory cardiac monitoring. The primary purpose of ambulatory electrocardiography (AECG) monitoring is the evaluation of suspected arrhythmias that have not been detected in office- or hospital-based monitoring, generally while the individual is engaged in daily activities, including sleep. These devices differ in the types of monitoring leads used, the duration and continuity of monitoring, the ability to detect arrhythmias without individual intervention, and the mechanism of delivery or information from the individual to the clinician. Traditionally, these devices may be used for the evaluation of symptoms suggestive of arrhythmias such as syncope or palpitations. Other common clinical uses include the detection of atrial fibrillation (AF) in individuals who have undergone cardiac ablation of AF, or who have a history of cryptogenic stroke; the assessment of treatment response to antiarrhythmic therapy; the assessment of pacemaker and implantable cardioverter defibrillator (ICD) function; the evaluation of idiopathic hypertrophic cardiomyopathy; or the evaluation for suspected myocardial ischemia.

CONTINUOUS AMBULATORY ELECTROCARDIOGRAPHY (AECG) MONITORING (HOLTER MONITORING)

Continuous AECG monitoring (Holter monitoring) is a noninvasive test in which the electrocardiogram (ECG) is continuously recorded over an extended period of time, typically 24 to 48 hours, to evaluate fairly frequent symptoms (e.g., palpitations, dizziness, syncope) suggestive of cardiac arrhythmias. A Holter monitor is about the size of a large deck of cards. It can be clipped to a belt or carried in a pocket. Wires connect the device to electrodes that are placed on specified areas of the chest using sticky patches. These electrodes (sensors) detect the heart's electrical signals, and the monitor records heart rhythm. The heart's activity is recorded rather than transmitted. Holter monitoring, however, may be ineffective in detecting arrhythmias if an individual experiences infrequent symptoms. Therefore, the sensitivity of Holter monitoring is low for the detection of arrhythmias that are intermittent.

POST-EVENT CARDIAC DETECTION MONITORING

A cardiac event detection monitor can be either a hand-held device or worn on a wrist. When the individual feels a symptom or irregular heartbeat, the monitor is placed on the chest and a recording button is activated. The back of this device has small metal disks that function as the electrodes. If the monitor is worn on a wrist, a button is pressed to record. Some of these types of cardiac event detection monitors typically only record the rhythm that occurs with an individual's perceived symptoms and not those events that are asymptomatic. These monitors, referred to as postevent monitors, are of limited utility, as they do not include a memory loop, so they have no memory to allow recording of the rhythm before the device is activated. The device transmits ECG data telephonically to a central monitoring center and then is uploaded to a secured computer for analysis.

For example, in September 2011, the US Food and Drug Administration (FDA) gave 510(k) approval to the REKA E100™ system, a noncontinuous single-lead cardiac event detection 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 individual's circulation. First, a zero-lead device that is separate from the body and may be carried in a purse or coat pocket. If an individual's circulation is determined to be inadequate, a single electrode lead that the individual connects to the device at the time of an event is another option. The zero-lead device records an event by individual activation and can record and store up to 2,000 readings. The individual has the choice of sending stored event information to the monitoring center across a phone application or the internet on their computer. The monitoring center provides the EGG data to the referring professional provider for evaluation.

EXTERNAL CARDIAC EVENT DETECTION MONITORING (EXTERNAL LOOP MONITORING)

External cardiac event detection monitoring (external loop monitoring), typically involves long-term (30 days or more) monitoring of the heart rhythm of an individual with significant, but very infrequent, symptoms that are suggestive of transient cardiac arrhythmia. The infrequency of the arrhythmia makes it difficult to identify on a 24- or 48-hour continuous Holter monitor.

External cardiac event detection monitoring (external loop monitoring) is initiated in either the office or the home setting. The device is an ECG recording monitor with a continuous loop that attaches to the chest with electrodes, and is typically worn up to 1 month or longer. The device records the ECG in a continuous manner, but stores only a brief period of ECG recording in memory. When the event marker is activated at the time of a symptom, the device's looping memory is individually programmed to record an ECG 30 to 90 seconds prior to activation, and the next minute or so after activation. In addition to patient-activated monitoring, autotriggering monitoring is available. Autotriggering loop monitors have the capability to be automatically activated in the case of a predefined arrhythmia, such as asystole of greater than 3 seconds, and/or other variable rate and rhythm intervals. Autotriggering loop monitors do not rely on an individual's ability to activate and, as a result, are able to capture asymptomatic, in addition to symptomatic events.

Information may be stored in the device and later reviewed or transmitted from the monitoring device to a receiving monitoring center where the data are reviewed. The transmission ranges from the simple, analog dial-in transtelephonic system, to a cellular phone link, or a wireless link or Internet-based in-home computer that captures and stores ECG data. Currently, no one system is proven to be superior to another.

A representative example of a patient-activated external looping monitor includes the Zio® Event Card (iRhythm Technologies, Inc., San Francisco, CA). In June 2008, the FDA gave 510(k) approval to the a noncontinuous real-time recording device Zio® Event Card that can be worn up to 30 days. This device can be worn under clothing (including during sleep), as it weighs less than 2 ounces and is similar in size to a standard credit card. Upon activation by the individual, 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 upon symptom activation. After the device is activated, the individual is responsible for calling the iRhythm National Clinical Center (NCC), which then instructs the individual on sending the event over the phone line.

Other devices for external loop monitoring include King of Hearts Express® AF (Istromedix®, San Diego, CA), Looping Multi-Event Monitor (CardioNet Inc., Conshohocken, PA), and LifeStar AF Express (Life Watch, Buffalo Grove, IL).

CONTINUOUS AMBULATORY ELECTROCARDIOGRAPHY MONITORING (AECG) FOR PERIODS GREATER THAN 48 HOURS

Despite the clinical utility of 24- or 48-hour continuous Holter monitoring in clinical cardiology, issues such as diagnostic yield and individual compliance have prompted the development of ultra-portable devices for extended monitoring, referred to as ECG patch monitors. For example, the FDA approved the Zio® Patch (iRhythm Technologies Inc., San Francisco, CA), Model Z100, and the Zio® Patch in May 2009 and February 2012, respectively. Both approvals carry the same indication for use as a prescription-only, single-use, continuous recording ECG monitor that can be worn for up to 14 days. The device is indicated for use on individuals who experience transient symptoms such as syncope, palpitations, shortness of breath, or chest pains. The Zio® Patch system is most analogous to a 24- or 48-hour continuous Holter monitor that records and stores information. The available published peer-reviewed literature suggests that Zio® Patch typically detects a greater number of arrhythmias during extended follow-up than 24- or 48-hour Holter monitor. 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 individual keeps a symptom log. At the end of the recording period, the individual mails back the recorder in a prepaid envelope to a central center where the ECG data are analyzed via a proprietary algorithm using the Zio ECG Utilization Service (ZEUS) System. A full report is provided to the referring professional provider for interpretation and clinical management.

Other similar continuous AECG monitoring devices with recording periods greater than 48 hours include the CAM™ Patch (BardyDx, Vashon Island, WA), myPatch® (dms-service LLC, Santa Monica, CA), Stealth™ Monitor (Cardiac Insight Inc., Bellevue, WA).

MOBILE CARDIAC OUTPATIENT TELEMETRY (MCOT) MONITORING

Although many monitors have automatic activation capability and allow the individual to transmit data to a monitoring center, they do not automatically transmit the data at the time of occurrence to an attended monitoring center. An MCOT is an automatically activated device that requires no active intervention to capture or transmit an arrhythmia when it occurs, although data can also be recorded through patient activation. Mobile cardiac outpatient telemetry is the real-time transmission of the individual's cardiac activity to a receiving monitoring center that converts this electronic transmission into a visible image; this image is constantly and continuously displayed on a monitor so that qualified technicians located in the receiving monitoring center can provide immediate and accurate surveillance of the individual's cardiac activity 24 hours a day, 7 days a week. The individual's referring professional provider is made aware of arrhythmias based on predetermined notification criteria specific to that individual. The ability to respond immediately when clinically important arrhythmias occur is the major advantage real-time MCOT monitoring.

For example, CardioNet® Inc. (Conshohocken, PA) offers MCOT monitoring. In this system, the individual 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 professional provider. The referring professional provider can request the level and timing of response, ranging from daily reports to stat results. Other systems for MCOT monitoring include the HEARTLink II™ system (Cardiac Telecom Corp., Greensburg, PA), the Vital Signs Transmitter (VST™; Biowatch Medical, Columbia, SC), and the LifeStar™ Ambulatory Cardiac Telemetry (ACT) system (Card Guard Scientific Survival Ltd., Israel).

In February 2014, the FDA gave 510(k) approval to the Nuvant Mobile Cardiac Telemetry (MCT) System, now known as SEEQ MCT (Medtronic, Inc. Minneapolis, MN). SEEQ™ MCT is a one-time use, wearable adhesive cardiac sensor that can be worn up to 30 days. SEEQ™ MCT is intended to continuously measure, record, and periodically transmit physiological data. The wearable, wireless-enabled sensor continuously monitors the heart and automatically transmits rhythm abnormalities to the cardiographic technicians at the Medtronic Monitoring Center. Individuals can also trigger transmission of ECGs when they experience cardiac symptoms by using the trigger button. Reports are provided to the referring professional providers for review and analysis. This system is indicated for those individuals who require monitoring for the detection of nonlethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (SVTs) (e.g., atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias, and conduction disorders.

In August 2012, the FDA gave 510(k) clearance to the BodyGuardian Remote Monitoring System™ (Price® Inc., Minneapolis, MN). The monitoring system continuously detects and records a variety of physiologic data including ECG tracing, respiratory rate, and activity level for up to 30 days. The data are delivered securely from the BodyGuardian Control Unit to the BodyGuardian Connect smartphone device. In turn, the individual data are wirelessly delivered to the Price® CarePlatform, a cloud-based mobile health (mHealth) platform that collects real-time data from devices and delivers information to the referring professional providers.

In November 2011, the FDA gave 510(k) clearance to the VectraplexECG™ System (VectraCor Inc., Totowa, NJ, and Maple Grove, MN). This 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 professional provider. The individual 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. Although this system is primarily intended to monitor for ischemia, the continuous ECG monitoring would presumably detect rhythm disturbances, as well as ischemic changes.

CARDIAC EVENT DETECTION MONITORING (IMPLANTABLE LOOP MONITORING)

A cardiac event detection monitor (implantable loop monitor) is an implantable device that is inserted subcutaneously, usually in a left pectoral or mammary location. The electrodes that sense the heart's activity are on the surface of the device, so no transvenous leads are necessary. Prior to the device insertion, the monitor may be initially programmed. For a patient-activated monitoring system, when symptoms occur, the individual uses a hand-held activator to store a segment of the ECG in the device's memory. Autotriggering technology can be adapted to the implantable cardiac loop monitoring devices. For example, implantable autotrigger loop monitors have the capability to be automatically activated in the case of a predefined arrhythmia such as asystole of greater than 3 seconds, and/or other variable rate and rhythm intervals. The device's looping memory is individually programmed to record an ECG 30 to 90 seconds prior to activation. The newest generations of these devices allow remote transmission of data, and have a projected longevity of the device's battery for up to 3 years. The professional provider utilizes a programmer to retrieve, display, and print stored data. Implantable cardiac loop monitors have the capacity to record cardiac events for approximately 3 years and to store many separate events.

For example, the Reveal® XT ICM (Medtronic Inc., Minneapolis, MN) is an implantable memory loop device cleared for marketing by the FDA in 2008 that allows patient-activated rhythm recording, rhythm recording at prespecified time intervals, or autotriggered rhythm recording. In February 2014, the FDA cleared for marketing the Reveal LINQ™, a miniaturized implantable memory loop device with an approximate volume of 1 mL that includes autotriggered or patient-activated rhythm recording.

The current clinical use of an implantable cardiac loop monitor involves the evaluation of transient, recurrent symptoms of possible arrhythmic origin, after a trial of cardiac event detection monitoring (i.e., external loop monitoring) does not yield a definitive diagnosis, and long-term monitoring is needed.

AECG MONITORING MANAGED THROUGH MOBILE APPLICATIONS FOR SMARTPHONE AND SMARTWATCH TECHNOLOGY

Trans-telephonic ECG event recorders record, store, and transfer single-channel electrocardiogram rhythms (e.g., KardiaMobile [previously AliveCor ECG, AliveCor Heart Monitor], KardiaBand). These devices utilize the processing power of a mobile application to obtain and analyze single-channel ECG. The device is placed on the chest or held by the individual’s hands while pressing fingers from each hand onto the electrodes to provide a single-channel ECG rhythm strip. Similar to other mobile ECG devices, the devices use a proprietary method of data transmission using acoustic waves to communicate with the mobile application where the waveform is stored, displayed, and analyzed for the presence of an irregular heart rhythm. They are designed to work in conjunction with a range of mobile platforms, including iPhone, iPad, and Android devices, and may be obtained without a prescription. AECG monitoring managed through mobile applications for smartphone and smartwatch technology are intended for use by healthcare professionals, individuals with known or suspected heart conditions, and health-conscious individuals. These devices provide a single-lead ECG and cannot provide the level and detail obtained by the typical 12-lead ECG performed by professional providers.

The accuracy of smartphone-based applications intended to measure heart rate varies widely. Investigators evaluated the accuracy of four randomly selected, commercially available applications intended to measure heart rate using two types of smart phones (iOS) (Coppetti et al., 2017). The applications are based on photoplethysmography, an optical technique that measures light reflectance to detect blood volume changes in the microvasculature. The two contact-based applications require individuals to place a finger on the smart phone's built-in camera. Researchers randomly recruited 108 noncritical individuals who required heart rate monitoring in a chest pain unit or emergency department. They measured heart rate simultaneously using the applications on both smartphones, conventional ECG, and pulse oximetry. The researchers found differences greater than 20 beats per minute compared to ECG in more than 20% of application measurements. Noncontact applications performed worse than contact applications, especially at higher heart rates and lower body temperatures. Noncontact applications tended to overestimate higher heart rates. Further, both contact applications performed differently. Researchers could not attribute the divergent contact application performance to camera technology, age, body temperature, or heart rate itself, suggesting the application's proprietary algorithm was the cause.

In addition, there is currently a lack of evidence to support the clinical value of AECG monitoring managed through mobile applications for smartphone and smartwatch technology. Prospective, randomized controlled studies are needed to ascertain how the use of these devices would improve clinical outcomes in individuals with cardiovascular diseases/disorders.

RECOMMENDATIONS FOR AMBULATORY ELECTROCARDIOGRAPHY (AECG) TYPE

Generally, the selection of a specific AECG monitoring device is based on the frequency with which the individual’s symptoms, thought to be related to cardiac arrhythmia, occur. For example, individuals with infrequent short periods of transient symptoms recurring over longer periods of time are unlikely to be diagnosed by conventional 24- or 48-hour continuous Holter monitoring, as the likelihood of symptom-ECG correlation is very low (Brignole et al., 2009).

According to the American College of Cardiology (ACC)/American Heart Association (AHA) Clinical Competence Statement on Electrocardiography and Ambulatory Electrocardiography (2001), there are no specific guidelines that distinguish individuals for whom it is appropriate to perform continuous monitoring from those for whom intermittent monitoring is adequate. However, when monitoring is performed to evaluate the cause of intermittent symptoms, the frequency of symptoms should dictate the type of recording. However, more recently, in 2006, the AHA/American College of Cardiology Foundation (ACCF) stated that Holter monitoring is appropriate for episodes that occur at least every day, and cardiac event detection monitoring is ideal for less-frequent episodes that occur at least once a month. Implantable loop monitoring is considered the most likely technology to identify the mechanism of syncope in individuals with unexplained syncope.

PRACTICE GUIDELINES

In 2023, the ACC/AHA/ACCP/HRS issued guidelines for the diagnosis and management of AF. These guidelines recommend initial cardiac monitoring and, if needed, extended monitoring with an implantable loop recorder for individuals with stroke or transient ischemic attack (TIA) of undetermined cause.

In 2021, the AHA/ASA issued guidelines for the prevention of stroke in individuals with stroke and transient ischemic attack. These guidelines recommend long-term rhythm monitoring with MCOT, implantable loop recorder, or other approach as reasonable to detect intermittent atrial fibrillation in individuals with cryptogenic stroke who do not have a contraindication to anti-coagulation.

In 2020, the AHA/ACC issued guidelines for the diagnosis and treatment of hypertrophic cardiomyopathy. Class I recommendations (i.e., conditions for which there is evidence and/or general agreement that the test is useful and effective) include 24-hour continuous AECG monitoring (Holter monitoring) or event recording monitoring for specified individuals with hypertrophic cardiomyopathy.

The use of cardiac event detection monitoring postablation is addressed in a consensus document published in 2017 by the HRS/EHRA/ECAS/APHRS/SOLAECE on catheter and surgical ablation for AF. This document provides general recommendations based on literature review and expert consensus. Based on such recommendations, following ablation for AF, individuals in whom discontinuation of systemic anticoagulation is being considered should consider undergoing continuous ECG monitoring.

In 2014 the American Academy of Neurology released updated guidelines on the prevention of stroke in individuals with nonvalvular atrial fibrillation (NVAF). The guidelines make the following recommendations regarding the identification of individuals with occult NVAF:

Outpatient cardiac rhythm studies may be obtained in individuals with cryptogenic stroke without known NVAF in order to identify individuals with occult NVAF.
Cardiac rhythm studies for prolonged periods (e.g., 1 or more weeks) instead of shorter periods (e.g., 24 hours) may be obtained in individuals with cryptogenic stroke without known NVAF in order to increase the yield of identification of individuals with occult NVAF.

In the 1999 Guidelines for AECG, the ACC/AHA discuss the following as a Class I indications:

Symptoms that may be related to disturbances of heart rhythm
Efficacy of antiarrhythmic therapy
Pacemaker and implantable cardioverter-defibrillator (ICD) function
Pediatric individuals

According to the ACC/AHA Guidelines for AECG, as in adults, selection of the method of monitoring (i.e., continuous recording versus patient-activated) for the pediatric population is predicated on the frequency and symptoms of the arrhythmia. Generally, the indications for pediatric AECG monitoring include the following:

The evaluation of symptoms that may be arrhythmia related
Risk assessment in individuals with cardiovascular disease, with or without symptoms of an arrhythmia
The evaluation of cardiac rhythm after an intervention such as drug therapy or device implantation

TECHNICAL AND PROFESSIONAL COMPONENTS

Ambulatory ECG technology varies among different devices. Ambulatory ECG may include technical and professional components. The technical component comprises the portion of the procedure or service performed by the monitoring center or independent diagnostic testing facility, and the equipment used for the procedure or service.

The professional component is the portion of the procedure or service performed by a professional provider, which includes the interpretation, analysis, and a detailed signed written report of the results of the procedure or service.

References

Agency for Healthcare Research and Quality (AHRQ). Technology assessment. Remote cardiac monitoring. [AHRQ Web site]. 02/14/2008. Available at: http://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id51TA.pdf. Accessed February 6, 2024.

AliveCore. Press Release. AliveCor announces smartphone electrocardiogram demonstrates accuracy in monitoring patients’ heart Health. [AliveCor Web site]. 05/12/2012. Available at:
https://www.alivecor.com/press/press_release/alivecor-announces-smartphone-electrocardiogram-demonstrates-accuracy-in-monitoring-patients-heart-health/. Accessed February 6, 2024.

American Stroke Association. Dilated cardiomyopathy. [American Stroke Association Web-site]. Available at: Dilated Cardiomyopathy (DCM) | American Stroke Association. Accessed February 6, 2024.

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Coding

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

0650T, 33285, 33286, 93224, 93225, 93226, 93227, 93228, 93229, 93241, 93242, 93243, 93244, 93245, 93246, 93247, 93248, 93268, 93270, 93271, 93272, 93285, 93291, 93297, 93298

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

MEDICALLY NECESSARY

G45.1 Carotid artery syndrome (hemispheric)

G45.2 Multiple and bilateral precerebral artery syndromes

G45.3 Amaurosis fugax

G45.8 Other transient cerebral ischemic attacks and related syndromes

G45.9 Transient cerebral ischemic attack, unspecified

G46.0 Middle cerebral artery syndrome

G46.1 Anterior cerebral artery syndrome

G46.2 Posterior cerebral artery syndrome

G90.01 Carotid sinus syncope

G90.A Postural orthostatic tachycardia syndrome [POTS]

I20.0 Unstable angina

I20.1 Angina pectoris with documented spasm

I20.81 Angina pectoris with coronary microvascular dysfunction

I20.89 Other forms of angina pectoris

I21.01 ST elevation (STEMI) myocardial infarction involving left main coronary artery

I21.02 ST elevation (STEMI) myocardial infarction involving left anterior descending coronary artery

I21.09 ST elevation (STEMI) myocardial infarction involving other coronary artery of anterior wall

I21.11 ST elevation (STEMI) myocardial infarction involving right coronary artery

I21.19 ST elevation (STEMI) myocardial infarction involving other coronary artery of inferior wall

I21.21 ST elevation (STEMI) myocardial infarction involving left circumflex coronary artery

I21.29 ST elevation (STEMI) myocardial infarction involving other sites

I21.4 Non-ST elevation (NSTEMI) myocardial infarction

I21.A1 Myocardial infarction type 2

I21.A9 Other myocardial infarction type

I21.B Myocardial infarction with coronary microvascular dysfunction

I22.0 Subsequent ST elevation (STEMI) myocardial infarction of anterior wall

I22.1 Subsequent ST elevation (STEMI) myocardial infarction of inferior wall

I22.2 Subsequent non-ST elevation (NSTEMI) myocardial infarction

I22.8 Subsequent ST elevation (STEMI) myocardial infarction of other sites

I23.7 Postinfarction angina

I24.81 Acute coronary microvascular dysfunction

I24.89 Other forms of acute ischemic heart disease

I25.10 Atherosclerotic heart disease of native coronary artery without angina pectoris

I25.110 Atherosclerotic heart disease of native coronary artery with unstable angina pectoris

I25.111 Atherosclerotic heart disease of native coronary artery with angina pectoris with documented spasm

I25.112 Atherosclerotic heart disease of native coronary artery with refractory angina pectoris

I25.118 Atherosclerotic heart disease of native coronary artery with other forms of angina pectoris

I25.2 Old myocardial infarction

I25.3 Aneurysm of heart

I25.41 Coronary artery aneurysm

I25.5 Ischemic cardiomyopathy

I25.6 Silent myocardial ischemia

I25.710 Atherosclerosis of autologous vein coronary artery bypass graft(s) with unstable angina pectoris

I25.711 Atherosclerosis of autologous vein coronary artery bypass graft(s) with angina pectoris with documented spasm

I25.712 Atherosclerosis of autologous vein coronary artery bypass graft(s) with refractory angina pectoris

I25.718 Atherosclerosis of autologous vein coronary artery bypass graft(s) with other forms of angina pectoris

I25.720 Atherosclerosis of autologous artery coronary artery bypass graft(s) with unstable angina pectoris

I25.721 Atherosclerosis of autologous artery coronary artery bypass graft(s) with angina pectoris with documented spasm

I25.722 Atherosclerosis of autologous artery coronary artery bypass graft(s) with refractory angina pectoris

I25.728 Atherosclerosis of autologous artery coronary artery bypass graft(s) with other forms of angina pectoris

I25.730 Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with unstable angina pectoris

I25.731 Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with angina pectoris with documented spasm

I25.732 Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with refractory angina pectoris

I25.738 Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with other forms of angina pectoris

I25.750 Atherosclerosis of native coronary artery of transplanted heart with unstable angina

I25.751 Atherosclerosis of native coronary artery of transplanted heart with angina pectoris with documented spasm

I25.752 Atherosclerosis of native coronary artery of transplanted heart with refractory angina pectoris

I25.758 Atherosclerosis of native coronary artery of transplanted heart with other forms of angina pectoris

I25.760 Atherosclerosis of bypass graft of coronary artery of transplanted heart with unstable angina

I25.761 Atherosclerosis of bypass graft of coronary artery of transplanted heart with angina pectoris with documented spasm

I25.762 Atherosclerosis of bypass graft of coronary artery of transplanted heart with refractory angina pectoris

I25.768 Atherosclerosis of bypass graft of coronary artery of transplanted heart with other forms of angina pectoris

I25.790 Atherosclerosis of other coronary artery bypass graft(s) with unstable angina pectoris

I25.791 Atherosclerosis of other coronary artery bypass graft(s) with angina pectoris with documented spasm

I25.792 Atherosclerosis of other coronary artery bypass graft(s) with refractory angina pectoris

I25.798 Atherosclerosis of other coronary artery bypass graft(s) with other forms of angina pectoris

I25.810 Atherosclerosis of coronary artery bypass graft(s) without angina pectoris

I25.811 Atherosclerosis of native coronary artery of transplanted heart without angina pectoris

I25.812 Atherosclerosis of bypass graft of coronary artery of transplanted heart without angina pectoris

I25.82 Chronic total occlusion of coronary artery

I25.83 Chronic atherosclerosis due to lipid rich plaque

I25.84 Coronary atherosclerosis due to calcified coronary lesion

I25.85 Chronic coronary microvascular dysfunction

I25.89 Other forms of chronic ischemic heart disease

I42.0 Dilated cardiomyopathy

I42.1 Obstructive hypertrophic cardiomyopathy

I42.2 Other hypertrophic cardiomyopathy

I42.3 Endomycardial (eosinophilic) disease

I42.4 Endocardial fibroelastosis

I42.5 Other restrictive cardiomyopathy

I42.6 Alcoholic cardiomyopathy

I42.7 Cardiomyopathy due to drug and external agent

I42.8 Other cardiomyopathies

I43 Cardiomyopathy in diseases classified elsewhere

I44.0 Atrioventricular block, first degree

I44.1 Atrioventricular block, second degree

I44.2 Atrioventricular block, complete

I44.30 Unspecified atrioventricular block

I44.39 Other atrioventricular block

I44.4 Left anterior fascicular block

I44.5 Left posterior fascicular block

I44.60 Unspecified fascicular block

I44.69 Other fascicular block

I44.7 Left bundle-branch block, unspecified

I45.0 Right fascicular block

I45.10 Unspecified right bundle-branch block

I45.19 Other right bundle-branch block

I45.2 Bifascicular block

I45.3 Trifascicular block

I45.4 Nonspecific intraventricular block

I45.5 Other specified heart block

I45.6 Pre-excitation syndrome

I45.81 Long QT syndrome

I45.89 Other specified conduction disorders

I45.9 Conduction disorder, unspecified

I46.2 Cardiac arrest due to underlying cardiac condition

I46.8 Cardiac arrest due to other underlying condition

I46.9 Cardiac arrest, cause unspecified

I47.0 Re-entry ventricular arrhythmia

I47.10 Supraventricular tachycardia, unspecified

I47.11 Inappropriate sinus tachycardia, so stated

I47.19 Other supraventricular tachycardia

I47.20 Ventricular tachycardia, unspecified

I47.21 Torsades de pointes

I47.29 Other ventricular tachycardia

I47.9 Paroxysmal tachycardia, unspecified

I48.0 Paroxysmal atrial fibrillation

I48.11 Longstanding persistent atrial fibrillation

I48.19 Other persistent atrial fibrillation

I48.20 Chronic atrial fibrillation, unspecified

I48.21 Permanent atrial fibrillation

I48.3 Typical atrial flutter

I48.4 Atypical atrial flutter

I48.91 Unspecified atrial fibrillation

I48.92 Unspecified atrial flutter

I49.01 Ventricular fibrillation

I49.02 Ventricular flutter

I49.1 Atrial premature depolarization

I49.2 Junctional premature depolarization

I49.3 Ventricular premature depolarization

I49.40 Unspecified premature depolarization

I49.49 Other premature depolarization

I49.5 Sick sinus syndrome

I49.8 Other specified cardiac arrhythmias

I49.9 Cardiac arrhythmia, unspecified

I5A Non-ischemic myocardial injury (non-traumatic)

I63.541 Cerebral infarction due to unspecified occlusion or stenosis of right cerebellar artery

I63.542 Cerebral infarction due to unspecified occlusion or stenosis of left cerebellar artery

I63.549 Cerebral infarction due to unspecified occlusion or stenosis of unspecified cerebellar artery

I63.59 Cerebral infarction due to unspecified occlusion or stenosis of other cerebral artery

I63.89 Other cerebral infarction

I63.9 Cerebral infarction, unspecified

I67.841 Reversible cerebrovascular vasoconstriction syndrome

I67.848 Other cerebrovascular vasospasm and vasoconstriction

I97.120 Postprocedural cardiac arrest following cardiac surgery

I97.121 Postprocedural cardiac arrest following other surgery

I97.190 Other postprocedural cardiac functional disturbances following cardiac surgery

I97.191 Other postprocedural cardiac functional disturbances following other surgery

Q20.3 Discordant ventriculoarterial connection

Q20.5 Discordant atrioventricular connection

Q20.8 Other congenital malformations of cardiac chambers and connections

Q20.9 Congenital malformation of cardiac chambers and connections, unspecified

Q21.11 Secundum atrial septal defect

Q21.12 Patent foramen ovale

Q21.13 Coronary sinus atrial septal defect

Q21.21 Partial atrioventricular septal defect

Q21.22 Transitional atrioventricular septal defect

Q21.23 Complete atrioventricular septal defect

Q21.3 Tetralogy of Fallot

Q24.6 Congenital heart block

R00.0 Tachycardia, unspecified

R00.1 Bradycardia, unspecified

R00.2 Palpitations

R00.8 Other abnormalities of heart beat

R06.00 Dyspnea, unspecified

R06.01 Orthopnea

R06.02 Shortness of breath

R06.09 Other forms of dyspnea

R06.3 Periodic breathing

R07.1 Chest pain on breathing

R07.2 Precordial pain

R07.89 Other chest pain

R07.9 Chest pain, unspecified

R10.13 Epigastric pain

R40.4 Transient alteration of awareness

R42 Dizziness and giddiness

R55 Syncope and collapse

R94.31 Abnormal electrocardiogram [ECG] [EKG]

Z09 Encounter for follow-up examination after completed treatment for conditions other than malignant neoplasm

Z86.73 Personal history of transient ischemic attack (TIA), and cerebral infarction without residual deficits

Z86.74 Personal history of sudden cardiac arrest

HCPCS Level II Code Number(s)

C1764	Event recorder, cardiac (implantable)
C1833	Monitor, cardiac, including intracardiac lead and all system components (implantable)
E0616	Implantable cardiac event recorder with memory, activator, and programmer

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Version Effective Date:

6/24/2024

Version Issued Date: