Medical Policy



Subject: Implantable Ambulatory Event Monitors and Mobile Cardiac Telemetry
Document #: MED.00051 Current Effective Date:    08/17/2017
Status: Revised Last Review Date:    08/03/2017

Description/Scope

This document addresses the use of implantable ambulatory event monitors and external mobile cardiac telemetry that is equipped with cellular telecommunications (also referred to as real-time remote heart monitors or mobile outpatient cardiac telemetry). 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.

Note: Please see the following related document for additional information:

Position Statement

Medically Necessary:

The use of implantable ambulatory event monitors is considered medically necessary for individuals who have a history of cryptogenic stroke and had a previous non-diagnostic trial of external ambulatory event monitoring.

The use of implantable ambulatory event monitors is considered medically necessary for individuals with recurrent syncope who have all of the following:

The use of mobile cardiac telemetry is considered medically necessary for individuals who have a history of cryptogenic stroke and have had a previous non-diagnostic trial of external ambulatory event monitoring.

Investigational and Not Medically Necessary:

The use of implantable ambulatory event monitors and mobile cardiac telemetry is considered investigational and not medically necessary when the above criteria have not been met, and for all other indications.

Rationale

Ambulatory event monitors were developed to provide longer periods of electrocardiogram monitoring, compared to ambulatory Holter electrocardiography, which is limited to 24 to 48 hours. With ambulatory event monitoring, the recording device is either worn continuously or activated only when the individual experiences symptoms. The recorded electrocardiograms are then either stored for future analysis or transmitted over telephone lines to a receiving station or to a cardiac monitoring service.

Implantable ambulatory event monitors are available for those instances where individuals experience symptoms and extended monitoring is needed. These devices are inserted just under the skin in the chest area during an outpatient surgical procedure. The device may remain implanted for over 1 year. Implantable loop recorders have the ability to record events either automatically (auto-activated) or by manual activation (self-activated).

External mobile cardiac telemetry relies on real-time remote heart monitors that integrate standard ambulatory event monitor devices with automated calling features, using computer dialing of land lines or cellular communication technology and monitoring services. As with standard ambulatory event monitors, real-time remote heart monitors use similar types of electrocardiographic leads and recording devices. However, when an arrhythmia is detected using external mobile cardiac telemetry, either automatically or by the individual himself/herself, the electrocardiogram record is reviewed and the treating physician may be notified when certain criteria are met.

Real-time transmission of recordings is the unique feature of external mobile cardiac telemetry, 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.

In 2010, Hoefman published a systematic review on diagnostic tools for detecting cardiac arrhythmias. This analysis included studies of subjects presenting with palpitations and compared the yield of remote monitoring for several classes of devices: Holter monitors; self-activated event recorders; auto-triggered event recorders; and implantable loop recorders. The yield varied among devices, with the auto-trigger devices offering the highest range of detection (72-80%), followed by the self-activated devices (17-75%), and Holter monitors (33-35%). No combined analysis was performed due to the heterogeneity of the study population and study design. Limitations in the evidence base precluded any specific recommendations on selection of devices. The authors concluded that the choice of device should be driven largely by the presence, type, and frequency of symptoms experienced by each individual.

Cryptogenic Stroke
There has been interest in the use of implanted ambulatory event monitors to detect atrial fibrillation in individuals with cryptogenic stroke. Cryptogenic stroke describes stroke without an identifiable cause, specifically a cardioembolic source, such as a patent foramen ovale or AF. When potential cardiovascular etiologies have been ruled out during an initial workup consisting of various imaging studies and electrocardiograms, then it is considered to be a "cryptogenic" stroke. It is estimated that some 36% of stroke survivors have cryptogenic stroke. It has been suggested that additional monitoring may identify atrial fibrillation in stroke initially categorized as cryptogenic (Tayal, 2008). The presence or absence of atrial fibrillation has a significant impact on post-stroke management.

The 30-Day Cardiac Event Monitor Belt for Recording Atrial Fibrillation after a Cerebral Ischemic Event (EMBRACE) trial enrolled 572 subjects with cryptogenic stroke or transient ischemic attack (TIA) of undetermined cause within the previous 6 months and no history of atrial fibrillation. Trial subjects were randomized to receive noninvasive ambulatory electrocardiogram monitoring with either a 30-day event-triggered loop recorder (intervention group) or a conventional 24-hour Holter monitor (control group). The primary outcome was newly detected atrial fibrillation lasting 30 seconds or longer within 90 days after randomization. Secondary outcomes included episodes of atrial fibrillation lasting 2.5 minutes or longer and anticoagulation status at 90 days. At 30 days, results indicated that atrial fibrillation lasting 30 seconds or longer was detected in 45 of 280 subjects (16.1%) in the intervention group, as compared with 9 of 277 (3.2%) in the control group (absolute difference, 12.9 percentage points; 95% confidence interval [CI], 8.0 to 17.6; p<0.001; number needed to screen, 8). Episodes of atrial fibrillation lasting 2.5 minutes or longer were present in 28 of 284 subjects (9.9%) in the intervention group, as compared with 7 of 277 (2.5%) in the control group (absolute difference, 7.4 percentage points; 95% CI, 3.4 to 11.3; p<0.001). By 90 days, oral anticoagulant therapy had been prescribed for more individuals in the intervention group than in the control group (52 of 280 [18.6%] vs. 31 of 279 [11.1%]; absolute difference, 7.5 percentage points; 95% CI, 1.6 to 13.3; p=0.01). Despite remaining questions regarding the clinical relevance of subclinical atrial fibrillation and what therapeutic benefit is associated with anticoagulation therapy in this population, the trial results have demonstrated that noninvasive ambulatory electrocardiogram monitoring for 30 days is superior to short-term 24-hour monitoring for the detection of atrial fibrillation in individuals with a history of stroke or TIA labeled as cryptogenic (Gladstone, 2015).

The Cryptogenic Stroke and underlying Atrial Fibrillation (CRYSTAL-AF) trial was a large, prospective, randomized controlled study that utilized parallel-group design to evaluate the time to first episode of atrial fibrillation by means of 6 months of continuous rhythm monitoring versus control treatment in subjects with a recent cryptogenic stroke or TIA but without a personal history of atrial fibrillation. Trial participants at 50 centers in the U.S., Canada and Europe were randomized in a 1:1 fashion to standard arrhythmia monitoring (in the control arm) or to implantation of a long-term, insertable, subcutaneous cardiac monitor (ICM) (in the continuous monitoring arm). The purpose of this trial was to assess whether a long-term electrocardiogram monitoring strategy with an ICM is superior to conventional follow-up for the detection of atrial fibrillation in subjects with cryptogenic stroke. The primary endpoint was time to detection of atrial fibrillation within 6 months after stroke, and the clinical follow-up period was at least 12 months. Secondary endpoints included the time to first detection of atrial fibrillation at 12 months of follow-up, recurrent stroke or TIA, and the change in use of oral anticoagulant drugs. Atrial fibrillation was defined as an episode of irregular heart rhythm, without detectable P waves, lasting more than 30 seconds, with events qualifying for analysis adjudicated by an independent committee. During the study period, 447 trial participants were enrolled and 441 were randomly assigned to either the ICM group (n=221) or the control group (n=220). The mean (± standard deviation [SD]) time between the index event and randomization was 38.1 ± 27.6 days. In 2014, results of the CRYSTAL-AF trial were published (Sanna, 2014). The rate of detection of AF at 6 months was 8.9% among the subjects assigned to the ICM group (n=19), as compared with 1.4% among subjects assigned to the control group (n=3) (hazard ratio [HR], 6.4; 95% CI, 1.9 to 21.7; p<0.001). The median time from randomization to detection of atrial fibrillation was 41 days (interquartile range, 14 to 84) in the ICM group and 32 days (interquartile range, 2 to 73) in the control group. Asymptomatic atrial fibrillation was noted in 14 of 19 first episodes in the ICM group (74%) and in 1 of 3 first episodes in the control group (33%). The yield of 3 detected episodes in the control group was from a total of 88 conventional electrocardiogram studies in 65 subjects, 20 occurrences of 24-hour Holter monitor in 17 subjects, and monitoring with an event recorder in 1 trial subject.  The rate of detection of atrial fibrillation at 12 months was 12.4% (29 subjects) in the ICM group, as compared with 2.0% (4 subjects) in the control group (HR, 7.3; 95% CI, 2.6 to 20.8; p<0.001). The median time from randomization to detection of atrial fibrillation was 84 days (interquartile range, 18 to 265) in the ICM group and 53 days (interquartile range, 17 to 212) in the control group. Asymptomatic atrial fibrillation was noted in 23 of 29 first episodes in the ICM group (79%) and in 2 of 4 first episodes in the control group (50%). When monitoring continued from 6 through 12 months, an additional 10 first episodes of atrial fibrillation were detected in the ICM group versus 1 in the control group, despite 34 conventional electrogram studies in 33 subjects and 12 occurrences of Holter monitor in 10 subjects. Ischemic stroke or TIA occurred in 11 subjects (5.2%) in the ICM group, as compared with 18 (8.6%) in the control group, during the first 6 months after randomization and in 15 subjects (7.1%) versus 19 (9.1%) during the first 12 months. The rate of oral anticoagulant use was 10.1% in the ICM group versus 4.6% in the control group at 6 months (p=0.04) and 14.7% versus 6.0% at 12 months (p=0.007). By 12 months, 97.0% of trial participants in whom atrial fibrillation had been detected were receiving oral anticoagulants.

In subgroup analysis, the higher rate of detection of atrial fibrillation with ICM, than with conventional follow-up, was consistent across all the prespecified subgroups, defined by age, sex, race or ethnic group, type of index event, presence or absence of patent foramen ovale, and CHADS2 score at 6 months, with no significant interactions. The results of subgroup analyses at 12 months were consistent with those at 6 months. At study closure, 277 subjects had completed the scheduled 18-month follow-up visit, 177 had completed the 24-month visit, 94 had completed the 30-month visit, and 48 had completed the 36-month visit (total follow-up, 815.5 subject years). A relatively small number of subjects were followed for more than 24 months, but at 36 months of follow-up, the rate of detection of atrial fibrillation was 30.0% in the ICM group (42 subjects) versus 3.0% in the control group (5 subjects) (HR, 8.8; 95% CI, 3.5 to 22.2; p<0.001). The most common adverse events associated with the ICM were infection (3 subjects [1.4%]), pain (3 subjects [1.4%]), and irritation or inflammation (4 subjects [1.9%]) at the insertion site. The ICM remained inserted in 98.1% of subjects at 6 months and in 96.6% of subjects at 12 months. The authors concluded that results of this manufacturer sponsored trial, despite study limitations, demonstrated that atrial fibrillation was more frequently detected with an ICM than with conventional follow-up in subjects with a recent cryptogenic stroke. Study results also showed that atrial fibrillation after cryptogenic stroke was most often asymptomatic and paroxysmal and, thus, unlikely to be detected by strategies based on symptom-driven monitoring or intermittent short-term recordings (Sanna, 2014).

In a 2015 meta-analysis by Sposato and colleagues, the authors looked at studies to estimate the proportion of individuals who were diagnosed with atrial fibrillation after a stroke or transient ischemic attack after undergoing four phases of serial cardiac monitoring. Phase 1 consisted of acute assessment in the emergency room and admission ECG, phase 2 was an acute inpatient stay which included serial ECGs, continuous ECG monitoring and cardiac telemetry, and Holter monitoring. Phase 3 was the first ambulatory period and consisted of ambulatory Holter monitoring. Phase 4 was the second ambulatory period and consisted of mobile cardiac outpatient telemetry, external loop recording and implantable loop recording. A total of 50 studies were analyzed and reviewed. During phase 1, 7.7% of individuals were diagnosed with post-stroke atrial fibrillation. During phase 2, 5.6% of individuals were diagnosed with post-stroke atrial fibrillation after serial ECG, 7.0% were diagnosed after continuous inpatient ECG monitoring, 4.1% were diagnosed after continuous inpatient cardiac telemetry, and 4.5% were diagnosed after inpatient Holter monitoring. During phase 3, 10.7% of individuals were diagnosed with post-stroke atrial fibrillation. During phase 4, 15.3% of individuals were diagnosed with post-stroke atrial fibrillation by mobile cardiac outpatient telemetry, 16.2% were diagnosed following external loop recording, and 16.9% were diagnosed following implantable loop recording. This analysis has limitations which include the subjective stratification into the four phases of cardiac monitoring. Also, only about 40% of individuals continued past phase 3 into phase 4 for continued monitoring. Age and risk factors for post-stroke atrial fibrillation varied across the 50 studies reviewed. While this analysis concludes that extended cardiac monitoring on an outpatient basis detects post-stroke atrial fibrillation, the proportion of individuals who were diagnosed in phase 4 by implantable loop recording did not differ significantly from those individuals diagnosed by mobile cardiac outpatient telemetry or external loop recording.

Syncope
There has also been interest in the use of implanted ambulatory event monitors for syncope. A 2006 two-phase study by Brignole and colleagues assessed the efficacy of a diagnostic and treatment strategy of early implantation of an ambulatory event monitor and specific therapy after recurrence of syncope in participants with recurrent suspected syncope. A total of 392 participants received implantable loop recorders and started phase I of the study. The participants were at least 30 years of age and had a history of three or more episodes of syncope over the previous 2 years. During a median follow-up of 9 months, 143 participants had recurrence of syncope. Of those 143 participants with recurrent syncope, 103 participants went on to be included in phase II of the study which included either implantable loop recorder-based therapy (n=53) or no specific therapy (n=50). For those who received the implantable loop recorder-based therapy, 47 people had pacemaker insertion, 4 people had catheter ablation, 1 person had an implantable defibrillator inserted and 1 person was placed on an anti-arrhythmic medication. With a median follow-up of 9 months for the phase II of the study, 6 participants who were assigned to the implantable loop recorder-based therapy had a total of 7 syncopal relapses while 17 people in the non-specific therapy group had 46 syncopal episodes.  This study demonstrated that, in a cohort of individuals with previous recurrent, unexplained syncope, the use of implantable loop recorders and subsequent targeted interventionwas effective in reducing the further recurrence of syncope.

The 2017 American College of Cardiology/American Heart Association/Heart Rhythm Society (ACC/AHA/HRS) guideline for the evaluation and management of patients with syncope defines syncope as "A symptom that presents with an abrupt, transient, complete loss of consciousness, associated with inability to maintain postural tone, with rapid and spontaneous recovery." An appropriate initial evaluation which could include a thorough history, physical exam, and electrocardiogram, should be done to try to determine the cause of the syncope. According to the ACC/AHA/HRS guideline, the physical exam should include orthostatic blood pressure measurements and changes of heart rate in the lying and sitting positions, on immediate standing, and after 3 minutes of upright posture. A basic neurological exam should also be performed as part of the physical exam. The ACC/AHA/HRS guideline also gives a IIa recommendation for an ambulatory event monitor for those individuals with syncope of suspected arrhythmic etiology.

Background/Overview

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 and ventricular fibrillation. 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 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, 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.

Definitions

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.

Automatic real-time event notification function: For the purpose of this document, automatic real-time event notification means that acquired electrocardiographic data is monitored continuously and providers are notified when pre-specified events are identified.

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.

Cryptogenic stroke: Cerebral infarction that despite evaluation is not attributable to other well-established singular etiologies including cardioembolism, large artery atherosclerosis, or thromboembolism, or small vessel occlusion.

Extended memory capacity: For the purpose of this document, extended memory capacity is considered more than 24 hours of accessible data [see also definition for codes 93228 and 93229].

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.

Syncope: A presentation of an abrupt, transient, complete loss of consciousness, that is associated with the inability to maintain postural tone, with a quick and spontaneous recovery.

Coding

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 may be Medically Necessary when criteria are met for implantable monitors:

CPT  
33282 Implantation of patient-activated cardiac event recorder
93285 Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified healthcare professional; implantable loop recorder system
HCPCS  
C1764 Event recorder, cardiac (implantable)
E0616 Implantable cardiac event recorder with memory, activator and programmer
   
ICD-10 Diagnosis  
I63.9 Cerebral infarction, unspecified
I69.30-I69.398 Sequelae of cerebral infarction
R55 Syncope and collapse
Z86.73 Personal history of transient ischemic attack (TIA), and cerebral infarction without residual deficits

When services may be Medically Necessary when criteria are met for external mobile cardiac telemetry:

CPT  
93228 External 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; review and interpretation with report by a physician or other qualified health care professional
93229 External 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 transmission of daily and emergent data reports as prescribed by a physician or other qualified health care professional
   
ICD-10 Diagnosis  
I63.9 Cerebral infarction, unspecified
I69.30-I69.398 Sequelae of cerebral infarction
Z86.73 Personal history of transient ischemic attack (TIA), and cerebral infarction without residual deficits

When services are Investigational and Not Medically Necessary:
For the procedure and diagnosis codes listed above when criteria are not met or for all other indications, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

References

Peer Reviewed Publications:

  1. Brignole M, Sutton R, Menozzi C, et al. Early application of an implantable loop recorder allows effective specific therapy in patients with recurrent suspected neurally mediated syncope. Eur Heart J. 2006; 27(9):1085-1092.
  2. Cotter PE, Martin PJ, Ring L, et al. Incidence of atrial fibrillation detected by implantable loop recorders in unexplained stroke. Neurology. 2013; 80(17):1546-1550.
  3. Edvardsson N, Frykman V, van Mechelen R, et al. Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry. Europace. 2011; 13(2):262-269.
  4. Etgen T, Hochreiter M, Mundel M, et al. Insertable cardiac event recorder in detection of atrial fibrillation after cryptogenic stroke: an audit report. Stroke. 2013; 44(7):2007-2009.
  5. Furukawa T, Maggi R, Bertolone C, et al. Additional diagnostic value of very prolonged observation by implantable loop recorder in patients with unexplained syncope. J Cardiovasc Electrophysiol. 2012; 23(1):67-71.
  6. Gang UJ, Jøns C, Jørgensen RM, et al.; CARISMA investigators. Heart rhythm at the time of death documented by an implantable loop recorder. Europace. 2010; 12(2):254-260.
  7. Gladstone DJ, Dorian P, Spring M, et al. Atrial premature beats predict atrial fibrillation in cryptogenic stroke: results from the EMBRACE trial. Stroke. 2015; 46(4):936-941.
  8. Gladstone DJ, Spring M, Dorian P, et al. Atrial fibrillation in patients with cryptogenic stroke. N Engl J Med. 2014; 370(26):2467-2477.
  9. Hindricks G, Pokushalov E, Urban L, et al.; XPECT Trial Investigators. Performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation: results of the XPECT trial. Circ Arrhythm Electrophysiol. 2010; 3(2):141-147.
  10. Hoefman E, Bindels PJ, van Weert HC. Efficacy of diagnostic tools for detecting cardiac arrhythmias: systematic literature search. Neth Heart J. 2010; 18(11):543-551.
  11. 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.
  12. 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):875-881.
  13. Miller DJ, Khan MA, Schultz LR, et al. Outpatient cardiac telemetry detects a high rate of atrial fibrillation in cryptogenic stroke. J Neurol Sci. 2013; 324(1-2):57-61.
  14. Mittal S, Movsowitz C, Steinberg JS. Ambulatory external electrocardiographic monitoring: focus on atrial fibrillation. J Am Coll Cardiol. 2011; 58(17):1741-1749.
  15. 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.
  16. 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. 2014; 107(10):546-552.
  17. 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.
  18. 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):1449-1452.
  19. Sanna T, Diener HC, Passman RS, et al. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014; 370(26):2478-2486.
  20. 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. 2015; 14(4):377-387.
  21. 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.
  22. Tsang JP, Mohan S. Benefits of monitoring patients with mobile cardiac telemetry (MCT) compared with the Event or Holter monitors. Med Devices (Auckl). 2013; 7:1-5.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Albers GW, Amarenco P, Easton JD, et al. Antithrombotic and thrombolytic therapy for ischemic stroke: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition). Chest. 2008; 133(6 Suppl):630S-669S.
  2. January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014; 130(23):e199-267.
  3. Kernan WN, Ovbiagele B, Black HR, et al. Guidelines for prevention of stroke in patients with ischemic stroke and transient ischemic attack: a guideline for healthcare professions from the American Heart Association/American Stroke Association. Stroke. 2014; 45(7):2160-2236.
  4. Shen WK, Sheldon RS, Benditt DG, et al. 2017 ACC/AHA/HRS Guideline for the evaluation and management of patients with syncope: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines, and the Heart Rhythm Society. Circulation. 2017; 136(5):e25-e59.
Websites for Additional Information
  1. National Library of Medicine. Medical Encyclopedia: Arrhythmias. 2014. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/001101.htm. Accessed on May 19, 2017.
Index

Cardiac Event Monitors/Loop Recorders
Cardiogenic Shock
Heartrak ECAT
Mobile Cardiac Outpatient Telemetry (MCOT)
Syncope
TeleSense
TruVue® Wireless Ambulatory ECG Monitoring System

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.

Document History
Status Date Action  
Revised 08/03/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Added MN indications for implantable ambulatory event monitor for syncope. Updated Rationale, Definitions, Coding, References, and Index sections.  
  01/01/2017 Updated Coding section to include ICD-10-CM diagnosis codes and HCPCS code C1764.  
Revised 08/04/2016

MPTAC review. Added implantable ambulatory event monitors to scope and content of document, which was moved from CG-MED-40. Added MN statement for mobile cardiac telemetry. Updated Description/Scope, Rationale, Definitions and Reference sections.

Reviewed 02/04/2016

MPTAC review. Updated Rationale, Reference and Index sections. Removed ICD-9 codes from Coding section.

Reviewed 02/05/2015

MPTAC review. Updated Rationale, References, and Index sections.

Reviewed 02/13/2014

MPTAC review. Updated Rationale, References and Index.

Revised 02/14/2013

MPTAC review. Removed trade name from Position Statement. Updated Rationale, References and Index.

Reviewed 02/16/2012

MPTAC review. Updated Description/Scope, Rationale, Definitions, References, and Index.

Reviewed 02/17/2011

MPTAC review. Updated Rationale, References and Index.

  01/01/2011

Updated Coding section with 01/01/2011 CPT code descriptor changes.

Reviewed 05/13/2010

MPTAC review. Recent published literature was presented to MPTAC.

Reviewed 02/25/2010

MPTAC review. References were updated.

  01/01/2010

Updated Coding section with 01/01/2010 HCPCS changes; removed S0345, S0346, S0347 deleted 12/31/2009.

Reviewed 02/26/2009

MPTAC review. The Rationale, Background and References sections were updated.

  01/01/2009

Updated coding section with 01/01/2009 CPT changes.

Reviewed 02/21/2008

MPTAC review. References and Coding sections were updated. The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting.

Reviewed 03/08/2007

MPTAC review. Additional information added to the Rationale section regarding the Rothman trial of Cardionet. References and Coding sections were also updated.

Reviewed 06/08/2006

MPTAC review. References were updated with information from the ACC/AHA for ambulatory electrocardiography, evaluation of syncope and management of patients with supraventricular arrhythmias. 

  11/18/2005

Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).

Revised 07/14/2005 MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.
     
Pre-Merger Organizations Last Review Date Document Number Title  
Anthem, Inc. 10/27/2004 MED.00051 Real Time Remote Heart Monitors  
WellPoint Health Networks, Inc. 06/24/2004 9.04.02 Ambulatory Event Monitors to Detect Cardiac Arrhythmias