Medical Policy: 02.02.11
Original Effective Date: April 2006
Reviewed: December 2017
Revised: December 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.
Continuous monitoring devices with recording periods longer than a Holter
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:
- Noncontinuous devices with memory - 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).
- Continuous "memory loop" devices - 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.
Implantable continuous “memory loop” devices
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.
Mobile cardiac outpatient telemetry (MCOT)
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.
Practice Guidelines and Position Statements
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.
Ambulatory Event Monitors
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 (palpitations, 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:
- Who have been treated with catheter ablation; and
- In whom discontinuation of systemic anticoagulation is being considered; or
- As a means of evaluating rate control
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)
Implantable Ambulatory Monitors
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 palpitations, syncope or presyncope so infrequently that a prior trial of 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 (either patient or auto-activated/either non-continuous or continuous) has been non-diagnostic and symptoms persist. (33282, 33284, E0616, C1764)
Contraindications for the use of implantable ambulatory monitors include:
- Members condition is already indicated for implant with a pacemaker, an Implantable Cardioverter-Defibrillator (ICD), or Cardiac Resynchronization Therapy (CRT)
- Documented history of atrial fibrillation or atrial flutter or any other sustained arrhythmia
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 / Mobile Cardiac Telemetry (MCOT) (93228, 93229)
Real-time outpatient cardiac telemetry devices may be considered medically necessary for a narrow subset of patients when ALL of the following are met:
- Recurrent, unexplained episodes of presyncope or syncope occurring less frequently than once every 30 days
- A non-life-threatening cardiac arrhythmia is suspected as the cause of the above symptoms
- Non-diagnostic ambulatory event monitoring of a minimum of 30 days for recent episodes of presyncope or syncope
- Patient has never demonstrated evidence of sustained ventricular tachycardia or ventricular fibrillation
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
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.
The use of ambulatory event monitors managed by patients through a smartphone (i.e AliveCor) (0497T, 0498T) are considered investigational. The accuracy of capturing cardiac events is diminished compared to auto-activated devices and their value has not been proven over time in comparative studies.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis 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
- 0296T External electrocardiographic recording for more than 48 hours up to 21 days by continuous rhythm recording and storage; recording (includes connection and initial recording)
- 0297T External electrocardiographic recording for more than 48 hours up to 21 days by continuous rhythm recording and storage; scanning analysis with report
- 0298T External electrocardiographic recording for more than 48 hours up to 21 days by continuous rhythm recording and storage; review and interpretation
- 0497T External patient-activated, physician- or other qualified health care professional-prescribed, electrocardiographic rhythm derived event recorder without 24 hour attended monitoring; in-office connection
- 0498T External patient-activated, physician- or other qualified health care professional-prescribed, electrocardiographic rhythm derived event recording without 24 hour attended monitoring; review and interpretation by a physician or other qualified health care professional per 30 days with at least one patient-generated triggered event
- 33282 Implantation of patient-activated cardiac event recorder.
- 33284 Removal of an implantable, patient-activated cardiac event recorder.
- 93228 Wearable 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; physician review and interpretation with report
- 93229 Wearable 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; technical support for connection and patient instructions for use, attended surveillance, analysis and physician prescribed transmission of daily and emergent data reports
- 93268 External patient and, when performed, auto activated electrocardiographic rhythm derived event recording with symptom-related memory loop with remote download capability up to 30 days, 24-hour attended monitoring; includes transmission, review and interpretation by a physician or other qualified health care professional
- 93270 External patient and, when performed, auto activated electrocardiographic rhythm derived event recording with symptom-related memory loop with remote download capability up to 30 days, 24-hour attended monitoring; recording (includes connection, recording, and disconnection)
- 93271 External patient and, when performed, auto activated electrocardiographic rhythm derived event recording with symptom-related memory loop with remote download capability up to 30 days, 24-hour attended monitoring; transmission and analysis
- 93272 External patient and, when performed, auto activated electrocardiographic rhythm derived event recording with symptom-related memory loop with remote download capability up to 30 days, 24-hour attended monitoring; review and interpretation by a physician or other qualified health care professional
- C1764 Event recorder, cardiac (implantable)
- E0616 Implantable cardiac event recorder with memory, activator and programmer.
- Ermis, C Zhu AX, Pham S et al. Comparison of automatic and patient-activated arrhythmia recordings by implantable loop recorders in the evaluation of syncope. Am J Cardiol 2003; 92(7):815-9.
- Reiffel JA, Schwarzberg R, Murry M. Comparison of autotriggered memory loop recorders versus standard loop recorders versus 24-hour Holter monitors for arrhythmia detection. Am J Cardiol 2005; 95(9):1055-9.
- Balmelli N, Naegeli B, Bertel O. Diagnostic yield of automatic and patient-triggered ambulatory cardiac event recording in the evaluation of patients with palpitations, dizziness of syncope. Clin Cardiol 2003; 26(4):173-6.
- Ng E, Stafford PJ, Ng GA. Arrhythmia detection by patient and auto-activation in implantable loop recorders. J Interv Card Electrophysiol 2004; 10(2):147-52.
- 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.
- ECRI. Mobile Outpatient ECG Monitoring for Detecting Arrhythmia. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2005, March 15. 6 p (ECRI Hotline Responses). Also available: http//www.ecri.org.
- Agency for Healthcare Research and Quality (AHRQ). AHRP Technology Assessment Program. Remote cardiac monitoring. February 2008.
- 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. March 2007; 18: 241-47.
- 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
- 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.
- 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.
- ECRI. Mobile Cardiac Outpatient Telemetry for Detecting Arrhythmias. Plymouth Meeting (PA):ECRI Health Technology Information Service; 2010, June 16. (ECRI Hotline Service).
- Mittal S, Movsowitz C, Steinberg JS. Ambulatory external electrocardiographic monitoring: focus on atrial fibrillation. J Am Coll Cardiol 2011; 58(17):1741-9.
- Gumbinger C, Krumsdorf U, Veltkamp R et al. Continuous monitoring versus HOLTER ECG for detection of atrial fibrillation in patients with stroke. Eur J neurol 2012; 19(2):253-7.
- Lazzaro MA, Krishnan K, Prabhakaran S. Detection of atrial fibrillation with concurrent Holter monitoring and continuous cardiac telemetry following ischemic stroke and transient ischemic attack. J Stroke Cerebrovasc Dis 2012; 21(2):89-93.
- Calkins H, Kuck KH, Cappato R et al. 2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design. J Interv Card Electrophysiol 2012; 33(2):171-257.
- ECRI. Mobile cardiac outpatient telemetry for detecting arrhythmias. ECRI Health Technology Information Service; 2013, March 01. 9 p (ECRI Hotline Response).
- Turakhia MP, Hoang DD, Zimetbaum P et al. Diagnostic utility of a novel leadless arrhythmia monitoring device. Am J Cardiol 2013; 112(4):520-4.
- 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 2014; 127(1):95 e11-7.
- Kapa S, Epstein AE, Callans DJ et al. Assessing arrhythmia burden after catheter ablation of atrial fibrillation using an implantable loop recorder: the ABACUS study. J Cardiovasc Electrophysiol 2013; 24(8):875-81.
- January CT, Wann LS, Alpert JS et al. 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. Circulation 2014.
- Gladstone DJ, Spring M, Dorian P et al. Atrial fibrillation in patients with cryptogenic stroke. N Engl J Med 2014; 370(26):2467-77.
- Culebras A, Messe SR, Chaturvedi S et al. Summary of evidence-based guideline update: prevention of stroke in nonvalvular atrial fibrillation: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology 2014; 82(8):716-24.
- Ritter MA, Kochhauser S, Duning T et al. Occult atrial fibrillation in cryptogenic stroke: detection by 7-day electrocardiogram versus implantable cardiac monitors. Stroke 2013; 44(5):1449-52.
- 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 2014; 127(1):95 e11-7.
- Favilla CG, Ingala E, Jara J, et al. Predictors of finding occult atrial fibrillation after cryptogenic stroke. Stroke. May 2015;46(5):1210-1215. PMID 25851771
- Tung CE, Su D, Turakhia MP, et al. Diagnostic Yield of Extended Cardiac Patch Monitoring in Patients with Stroke or TIA. Front Neurol. 2014;5:266. PMID 25628595
- Plas GJ, Bos J, Velthuis BO, et al. Diagnostic yield of external loop recording in patients with acute ischemic stroke or TIA. J Neurol. Mar 2015;262(3):682-688. PMID 25557280
- Sposato LA, Cipriano LE, Saposnik G, et al. Diagnosis of atrial fibrillation after stroke and transient ischaemic attack: a systematic review and meta-analysis. Lancet Neurol. Apr 2015;14(4):377-387. PMID 25748102
- Edvardsson N, Garutti C, Rieger G, et al. Unexplained syncope: implications of age and gender on patient characteristics and evaluation, the diagnostic yield of an implantable loop recorder, and the subsequent treatment. Clin Cardiol. Oct 2014;37(10):618-625. PMID 24890550
- Podoleanu C, DaCosta A, Defaye P, et al. Early use of an implantable loop recorder in syncope evaluation: a randomized study in the context of the French healthcare system (FRESH study). Arch Cardiovasc Dis. Oct 2014;107(10):546-552. PMID 25241220
- Bolourchi M, Batra AS. Diagnostic yield of patch ambulatory electrocardiogram monitoring in children (from a national registry). Am J Cardiol. Mar 1 2015;115(5):630-634. PMID 25591894
- National Institute for Health and Care Excellence, (NICE) Zio services for detecting cardiac arrhythmias. March 28, 2017
- Shen W.K., et al. 2017 ACC/AHA/HRS guideline for the evaluation and management of patients with syncope:executive summary. March 2017 Circ.ahajournals.org. Doi: 10.1016/j.jacc.2017.03.003.
- December 2017 - Annual Review, Policy Revised
- May 2017 - Annual Review, Policy Revised
- May 2016 - Annual Review, Policy Revised
- June 2015 - Annual Review, Policy Renewed
- November 2014 - Annual Review, Policy Revised
- July 2014 - Annual Review, Policy Revised
- September 2013 - Annual Review, Policy Revised
- October 2012 - Annual Review, Policy Renewed
- April 2012 - Annual Review, Criterion Update
- October 2011 - Annual Review, Policy Renewed
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