This document addresses the use of real-time remote heart monitors. These are ambulatory event monitors with an additional feature that uses cellular telephone communications technology to communicate any abnormal heart rhythms in real time to a central monitoring station e.g., CardioNet^® Mobile Cardiac Outpatient Telemetry^™ System (CardioNet, Conshohocken, PA) and HEARTLink II^™ System (Cardiac Telecom Corporation, Greensburg, PA).

Investigational and Not Medically Necessary:

Ambulatory cardiac event monitors which include both an extended memory capacity and an automatic real-time event notification function, also known as real-time remote heart monitors, (e.g., CardioNet^® Mobile Cardiac Outpatient Telemetry^™ System and HEARTLink II^™ System) are considered investigational and not medically necessary for all indications.

Real-time remote heart monitors are devices that integrate standard ambulatory event monitor (AEM) devices with automated calling features, using computer dialing of land lines or cellular communication technology and monitoring services. As with standard AEMs, real-time remote heart monitors use similar types of electrocardiographic (ECG) leads and recording devices.  However, when a real-time remote heart monitor detects an arrhythmia, either automatically or by the individual himself/herself, the ECG record is transmitted to a service center, which may notify the treating physician if certain criteria are met. 

Therefore, when considering real-time remote heart monitors, two general outcomes must be considered; first whether or not the monitoring will capture arrhythmic events, and secondly whether or not the ability to transmit the recorded ECGs in real time provides any incremental health benefit, compared to the periodic transmission of recordings that is a component of conventional ambulatory event monitors. The technical ability of event monitors to record ECGs has been well established and is not considered further here. Real-time transmission of recordings is the unique feature of real-time remote heart monitors, and evaluation of this aspect of the technology requires consideration of the final health outcome. The use of real-time monitoring implies that there is a subset of individuals where immediate intervention is required when designated arrhythmias are noted. 

To date, studies of real-time remote heart monitors have focused on the technical abilities of the monitoring, and not on the identification of appropriate individuals for this added feature of real-time monitoring, or how real-time monitoring may change treatment management and improve outcomes. Rothman and colleagues (2007) reported the results of a multi center trial that randomized 266 participants to undergo monitoring with either a CardioNet^® Mobile Cardiac Outpatient Telemetry^™ system (MCOT^™) or "standard" loop event monitoring (LOOP). The participants were monitored for up to 30 days with the primary endpoint being the confirmation or exclusion of an arrhythmic cause for the individuals' symptoms (these being mainly syncope, presyncope or severe palpitations). Of the 266 participants analyzed, a diagnosis was made in 88% of the MCOT^™ group, compared to 75% of the LOOP group. However, the "standard" LOOP monitors did not include an autotrigger function to automatically record the occurrence of asymptomatic arrhythmias, thereby relying on patient triggering, based on the presence of symptoms to record arrhythmias. Under these circumstances, it is not unexpected that the detection of asymptomatic arrhythmias would be greater in the MCOT^™ group and contribute to the overall increase in detection rate, compared to the LOOP group. The authors noted that the ability to detect or exclude an arrhythmia at the time of symptoms was similar in both groups. A post hoc analysis of a small subgroup of LOOP participants (n=26), who did, in fact, receive a loop recorder with an autotrigger function, revealed an arrhythmia was confirmed or excluded in only 46% of this subgroup. This finding is noticeably lower than the 75% diagnosis rate in the LOOP group, as a whole, who did not have the autotrigger capability. The authors do not discuss possible mechanisms for this finding; however, this subgroup involved only a small number of individuals from which to attempt to draw conclusions and further, the authors point out that the study was not designed to evaluate autotriggered loop recorders.

The above outcomes focus entirely on the ability of the monitor to record arrhythmias and do not address the important issue of the impact of the real-time monitoring features. Specifically, the study did not report on individuals or arrhythmias requiring urgent physician notification or intervention, therefore, the potential benefit of this particular capability, in terms of improved health outcomes, was not examined. Other recent studies also focus on the diagnostic capabilities of real-time monitors (Saarel, 2008; Tayal, 2008).

Further study is needed to isolate the contribution of the real-time transmission of recordings to the overall monitoring itself with state of the art event monitoring with autotrigger capabilities. Individuals requiring immediate intervention when a designated arrhythmia is noted are most likely to benefit from real-time monitoring; these high risk individuals are currently monitored in inpatient telemetry units or undergo electrophysiologic (EP) testing. It is unclear which individuals currently monitored in telemetry units could be adequately monitored and managed through remote monitoring. The Heart Rhythm Society (Moya, 2009) updated its guideline for syncope and addressed remote telemetry concluding "the potential role of these systems in the diagnostic work-up of patients with syncope needs to be further evaluated." Current clinical guidelines from the American College of Cardiology addressing arrhythmias, syncope and EKG monitoring refer to ambulatory monitoring in general but do not specifically address real-time remote monitoring.

Description of Disease

Arrhythmias are deviations from the normal cadence of the heartbeat which cause the heart to pump improperly. More than four million Americans have arrhythmias, most of which pose no significant health threat. As people age, the probability of experiencing an arrhythmia increases. A subset of individuals, however, is prone to serious arrhythmias; these individuals often have ischemic heart disease, increasing the probability of such arrhythmias. Serious arrhythmias include, among others, ventricular tachyarrhythmias, such as ventricular tachycardia (VT) and ventricular fibrillation (VF). In the United States, arrhythmias are the primary cause of sudden cardiac death, accounting for more than 350,000 deaths each year. The standard initial measure for a diagnosis of arrhythmias involves the use of electrocardiogram (ECG) testing, which allows evaluation of the electrical function of the heart. 

Longer monitoring periods using different types of monitors are required for intermittent arrhythmias. A Holter monitor continuously records the electrical activity of the heart for a period of 24-48 hours. When this time has elapsed, the device is removed, and the collected data are evaluated by a physician to help identify irregular heart rhythms. Most Holter monitors have incorporated a button that individuals push when symptomatic. This button indicates in the data where the symptoms occurred in relation to the electrical recording.

In other cases, the 24 hour recording period allowed by a Holter monitor is insufficient. In these cases, ambulatory event monitors (AEMs), also referred to as loop recorders, may be indicated. These devices are similar to Holter monitors but allow data collection over a few days up to a month. Unlike Holter monitors, these devices usually do not continuously record data but do so when activated by a symptomatic individual or may be autotriggered by an arrhythmia. Most event monitors have the ability to allow the data collected to be manually transmitted via telephone to monitoring centers attended by technicians 24 hours a day, 7 days a week. The data can be available to the physician within moments of an event. Most event recorders can be worn on an individual's belt or carried in some other manner. In the most extreme cases, these devices may be surgically implanted under the skin. Finally, implantable loop recorders can record data for up to a year. The selection of the most appropriate monitor is based on the anticipated frequency of symptoms. The unique feature of real-time remote heart monitors is the ability to immediately communicate designated abnormal rhythms to a central monitoring station for immediate evaluation and physician notification. 

Ambulatory event monitors (AEM): Outpatient cardiac monitors that provide extended periods of monitoring (up to a month). They are used in cases such as arrhythmias that occur infrequently. The device may be automatically or manually activated.

Autotrigger AEM: Outpatient cardiac monitors that provide extended periods of monitoring (up to 30 days), programmed to automatically capture arrhythmias (predefined tachycardia, bradycardia, atrial fibrillation). These devices may be user activated for symptomatic episodes.

Holter monitor: A widely used noninvasive test in which an ECG is continuously recorded over an extended time period, usually 24 to 48 hours, to evaluate symptoms of cardiac arrhythmias, such as palpitations, dizziness, or syncope.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. 

When services are Investigational and Not Medically Necessary:

Peer Reviewed Publications:

1. 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):878-881.
2. Louis AA, Turner T, Gretton M, et al. A systematic review of telemonitoring for the management of heart failure. Eur J Heart Fail. 2003; 5(5):583-590.
3. Naccarelli GV.  Ambulatory electrocardiographic monitoring: Has mobile cardiac outpatient telemetry changed the playing field? J Cardiovasc Electrophysiol. 2007; 18(3):248-249.
4. Olson JA, Fouts AM, Padanilam BJ, et al. Utility of mobile cardiac outpatient telemetry for the diagnosis of palpitations, presyncope, syncope, and the assessment of therapy efficacy. J Cardiovasc Electrophysiol. 2007; 18(5):473-477.
5. 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):1055-1059.
6. Rothman SA, Laughlin JC, Seltzer J, et al. The diagnosis of cardiac arrhythmias: a prospective multi-center randomized study comparing mobile cardiac outpatient telemetry versus standard loop event monitoring. J Cardiovasc Electrophysiol. 2007; 18(3):241-247.
7. 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):33-38.
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):1696-1701.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Agency for Healthcare Research and Quality. Remote cardiac monitoring. Technology Assessment. 2007 Dec. No. 290-02-0019.
2. Blomstrom-Lundqvist C, Scheinman MM, Aliot EM, et al. ACC/AHA/ESC Guidelines for the Management of Patients with Supraventricular Arrhythmias: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to develop guidelines for the management of patients with supraventricular arrhythmias). 2003; 108(15):1871-1909.
3. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination: Electrocardiographic (EKG) Services. NCD #20.15. Effective August 26, 2004. Available at: http://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx. Accessed on November 1, 2010. 
4. Crawford MH, Bernstein SJ, Deedwania PC, et al. ACC/AHA guidelines for ambulatory electrocardiography: A report of the American College of Cardiology/American Heart Association task force on practice guidelines (committee to revise the guidelines for ambulatory electrocardiography). Circulation. 1999; 100(8):886-893.
5. Kadish AH, Buxton AE, Kennedy HL, et al. ACC/AHA clinical competence statement on electrocardiography and ambulatory electrocardiography: A report of the ACC/AHA/ACP-ASIM task force on clinical competence (ACC/AHA committee to develop a clinical competence statement on electrocardiography and ambulatory electrocardiography). Circulation. 2001; 104(25):3169-3178.
6. Moya A, Sutton R, Ammirati F, et al. Guidelines for the diagnosis and management of syncope (version 2009): the Task Force for the Diagnosis and Management of Syncope of the European Society of Cardiology (ESC). Eur Heart J. 2009; 30(21):2631-2671.
7. Strickberger SA, Benson DW, Biaggioni I, et al. ACC/ACCF Scientific Statement on the evaluation of syncope: from the American Heart Association Councils on Clinical Cardiology, Cardiovascular Nursing, Cardiovascular Disease in the Young, and Stroke, and the Quality of Care and Outcomes Research Interdisciplinary Working Group; and the American College of Cardiology Foundation in collaboration with the Heart Rhythm Society. J Am Coll Cardiol. 2006; 47(2):473-484.
8. U.S. Food and Drug Administration Center for Devices and Radiologic health. CardioNet Ambulatory ECG Monitor. Model CN 1000A. No. K003707. Rockville, MD: FDA. May 16, 2001. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/K003707.pdf. Accessed on November 1, 2010.
9. U.S. Food and Drug Administration Center for Devices and Radiologic Health. CardioNet Ambulatory ECG Monitor, Model 1002. No. K052240. Rockville, MD: FDA. August 11, 2005. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K052240.pdf. Accessed on November 1, 2010.
10. U.S. Food and Drug Administration Center for Devices and Radiologic Health. CardioNet Ambulatory ECG Monitor with arrhythmia detection Model 1003. No. K053263. Rockville, MD: FDA. April 25, 2006. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K053263.pdf. Accessed on November 1, 2010.
11. U.S. Food and Drug Administration Center for Devices and Radiologic Health. CardioNet Ambulatory ECG Monitor with arrhythmia detection Model CN 1004. No. K063222. Rockville, MD: FDA. November 14, 2006. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063222.pdf. Accessed on November 1, 2010.
12. U.S. Food and Drug Administration Center for Devices and Radiologic Health. CardioNet Ambulatory ECG Monitor with arrhythmia detection Model CN 1005. No. K072558. Rockville, MD: FDA. December 5, 2007. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf7/K072558.pdf. Accessed on November 1, 2010.
13. U.S. Food and Drug Administration Center for Devices and Radiologic Health. Vital Signs Recorder and Transmitter (VST™). No. K040942. Rockville, MD: FDA. September 15, 2004. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/K040942.pdf. Accessed on November 1, 2010.

1. National Library of Medicine. Medical Encyclopedia: Arrhythmias. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/001101.htm. Accessed on November 1, 2010.

Ambulatory Cardiac Telemetry - CG-6108 ACT™
Cardiac Surveillance at Home, Real-Time Remote Heart Monitors
CardioNet^® Mobile Cardiac Outpatient Telemetry^™ Service (MCOT^™)
CG™-6106™ Personal 1-Lead ECG Monitor
CG-7000DX BT
HEARTLink II^™ System
King of Hearts Express^® AF
King of Hearts Express^®
LifeStar ACT Ambulatory Cardiac Telemetry
LifeStar PMP Wireless Tele-Diagnostic System
NUVANTT™ Mobile Cardiac Telemetry System
PMP4 Self Check ECG
PMP4^® Wireless Healthcare System
Telemetry @ Home^™

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.