Clinical UM Guideline
|Subject:||Ambulatory Event Monitors to Detect Cardiac Arrhythmias|
|Guideline #:||CG-MED-40||Current Effective Date:||07/15/2014|
|Status:||Reviewed||Last Review Date:||05/15/2014|
This document addresses the use of both standard external and implantable ambulatory event monitors (AEMs) for the detection of abnormal heart rhythms that cannot be detected by other means. This document does not address the use of AEMs equipped with cellular telecommunications equipment for real time physician notification. For information related to these devices, refer to MED.00051 Real-Time Remote Heart Monitors. Also, this document does not address continuous 24-48 hour Holter monitoring.
The use of external ambulatory event monitors is considered medically necessary as a diagnostic alternative to Holter monitoring in individuals who experience infrequent symptoms (less frequently than once every 48 hours) suggestive of cardiac arrhythmias.
The use of implantable ambulatory event monitors is considered medically necessary only in the small subset of individuals who experience recurrent symptoms so infrequently that a prior trial of Holter monitor or an external ambulatory event monitor are not likely to be successful.
Not Medically Necessary:
Other uses of ambulatory event monitors and telemetry are considered not medically necessary including, but not limited to, the following clinical situations:
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.
|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|
|33282||Implantation of patient-activated cardiac event recorder|
|93268-93272||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 [includes codes 93268, 93270, 93271, 93272]|
|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|
|E0616||Implantable cardiac event recorder with memory, activator, and programmer|
|ICD-9 Diagnosis||[For dates of service prior to 10/01/2015]|
|ICD-10 Diagnosis||[For dates of service on or after 10/01/2015]|
Ambulatory event monitors (AEMs) were developed to provide longer periods of EKG monitoring, compared to ambulatory Holter electrocardiography, which is limited to 24 to 48 hours. With AEM, the recording device is either worn continuously or activated only when the individual experiences symptoms. The recorded EKGs are then either stored for future analysis or transmitted over telephone lines to a receiving station, that is, a doctor's office, hospital, or to a cardiac monitoring service.
Newer AEM devices have the capacity to transmit data to a monitoring station via cellular telephone connections in real time. These devices are not addressed in this document and are the subject of MED.00051 Real-Time Remote Heart Monitors.
Implantable AEMs are also available for those instances where individuals experience such infrequent symptoms that 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 one year. Implantable loop recorders have the ability to record events either automatically (auto-activated) or by manual activation (self-activated). An example of an implantable loop recorder (ILR) is the Reveal® Insertable Loop Recorder (Medtronic, Inc., Minneapolis, MN) which received clearance through the 510(k) premarket approval process from the U.S. Food and Drug Administration (FDA) in February 2001 as a Class II device.
In 1999, the American College of Cardiology (ACC), in conjunction with other organizations, published clinical guidelines for ambulatory electrocardiography with the following Class I recommendations (Crawford, 1999):
There were two Class IIa recommendations as follows:
These guidelines describe both Holter monitors and AEM devices, but the recommendations do not distinguish between the different types of monitors. These guidelines also predate the commercial availability of external loop recorders with autotriggered capability or implantable loop recorders (ILR). However, these guidelines are helpful to define the indications for ambulatory ECG in general, with the choice of specific device to be based on the frequency of symptoms. Of the Class I and IIa recommendations listed above, only the assessment of unexplained symptoms, such as syncope and palpitation, would occur infrequently enough to warrant the use of an AEM. The other indications could be adequately assessed with short term monitoring with a Holter monitor. Additionally, in 2001, the ACC published a clinical competence statement on ECG and ambulatory ECG (Kadish, 2001) which reiterated that the indications for ambulatory ECG had been addressed in the 1999 clinical guidelines (Crawford, 1999). The competence statement noted:
There are no specific guidelines that distinguish patients for whom it is appropriate to perform continuous monitoring, (i.e., Holter monitor) from those for whom intermittent ambulatory monitoring is adequate. However, when monitoring is performed to evaluate the cause of intermittent symptoms, the frequency of the symptoms should dictate the type of recording (Kadish, 2001).
In 2006, the American Heart Association (AHA), in conjunction with the ACC, the American College of Cardiology Foundation (ACCF) and other organizations, published a scientific statement on the evaluation of syncope (Strickberger, 2006). This scientific statement did not provide specific recommendations, but reviewed the role of "non-invasive ECG monitoring" in different clinical situations. AEM use was specifically identified as an accepted technique in individuals with syncope with an otherwise normal history and physical exam, as follows:
The type and duration of ambulatory ECG monitoring is dictated by the frequency of symptoms. A Holter monitor is appropriate for episodes that occur at least every day. Event monitoring is ideal for episodes that occur at least once a month. An implantable loop monitor allows the correlation of symptoms with the cardiac rhythm in patients in whom the symptoms are infrequent (Strickberger, 2006).
In 2011, a small study was published that investigated subjects with unexplained recurrent syncope due to idiopathic paroxysmal atrioventricular (AV) block, in the absence of structural heart disease and normal standard EKG and electrophysiological findings. This observational study, which followed 18 subjects for a total timeframe of 12 ± 8 years, included prolonged EKG monitoring with ILRs, as well as with Holter monitors and in-hospital telemetry, to confirm the common clinical and electrophysiological features of this distinct form of syncope. The authors acknowledged the need for larger prospective study to confirm their findings (Brignole, 2011).
In 2011, the ACC/ACCF published Guidelines for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy (HCM) within which only the following recommendation is made regarding cardiac event monitors: "Twenty-four–hour ambulatory (Holter) electrocardiographic monitoring or event recording is recommended in patients with HCM who develop palpitations or lightheadedness (Level of Evidence: B)" (Gersh, 2011).
There has also been interest in the use of AEM devices to further characterize atrial fibrillation (AF) in the following clinical situations:
Cryptogenic stroke describes stroke without an identifiable cause. Specifically, a cardioembolic source, such as a patent foramen ovale or AF, has been ruled out during an initial workup consisting of various imaging studies and ECGs. It is estimated that some 36% of stroke survivors have cryptogenic stroke. It has been suggested that additional monitoring may identify AF in stroke initially categorized as cryptogenic (Tayal, 2008). The presence or absence of AF has a significant impact on post-stroke management. For example, the AHA and the American Stroke Association (ASA) jointly published Guidelines for the Prevention of Stroke in Individuals with a prior Ischemic Stroke or Transient Ischemic Attack (TIA) (Sacco, 2006). These guidelines recommend that individuals with cryptogenic stroke take aspirin for secondary stroke prevention, while the ACC guidelines addressing AF recommend careful consideration of warfarin, due to its superior efficacy for stroke prevention (Fuster, 2006). Guidelines published by the American College of Chest Physicians (ACCP) also recommend anti-platelet therapy, (for example, aspirin) in individuals with cryptogenic stroke, while anticoagulation therapy is recommended in individuals with AF (Albers, 2008). However, none of these guidelines specifically recommend extended ECG monitoring in individuals with cryptogenic stroke.
Liao conducted a systematic review of noninvasive cardiac monitoring in the post-stroke setting where the authors specifically sought to determine the frequency of occult AF detected by noninvasive methods of continuous cardiac rhythm monitoring in consecutive individuals with ischemic stroke; a total of five prospective case series were included in the analysis. Five studies evaluated Holter monitoring for 24 to 72 hours in the inpatient setting and are not considered further. The two studies that focused on loop recorders, following a negative Holter monitor, are relevant to this discussion (Barthelemy, 2003; Jaboudon, 2004). New AF was identified in 5.7% and 7.7% of subjects, respectively (Liao, 2007). In the study by Jaboudon, oral anticoagulation was started in two of the seven subjects with new onset AF. The authors concluded that increased duration of monitoring appears to be associated with increased rates of detection of AF, however, the authors also comment that it is uncertain whether any type of monitoring, including Holter monitoring, should be routinely performed given the low incidence of AF.
An updated literature search revealed a retrospective study of mobile cardiac outpatient telemetry (MCOT) in individuals with cryptogenic stroke (Tayal, 2008) which is not addressed in this document. The study included 56 subjects with cryptogenic stroke; all subjects had undergone an admission ECG, inpatient cardio-telemetry and 24 hour Holter monitoring without evidence of AF. Subjects underwent additional monitoring with an AEM for a mean of 21 days; 27 episodes of AF were detected in 13 subjects (23%). In three subjects, AF lasted longer than 30 seconds; there were four episodes of AF lasting from 4 to 24 hours. The authors acknowledged that this study raised the issue of the clinical significance of short episodes of AF, specifically whether or not this finding should warrant long-term anti-coagulation therapy, which is associated with its own risks and benefits. The predominant finding in this study was brief episodes of AF lasting less than 30 seconds. The authors noted that the natural history of these brief episodes remains poorly understood, and the optimal management of individuals with brief runs of AF has not been established.
In summary, the available data suggest the clinical validity of prolonged EKG monitoring in individuals with cryptogenic stroke. However, there are inadequate studies of the clinical utility of this technology, specifically the timing of monitoring post-stroke, the clinical significance of short runs of AF and the impact on the decision of whether or not to initiate anticoagulation therapy. More recent studies of ILRs show similar results in the detection of AF and evaluation of syncope but acknowledge the need for larger studies to evaluate the clinical validity of this technology (Hanke, 2009; Hindricks, 2010; Jacob, 2010).
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; patient-activated event recorders; auto-triggered event recorders; and ILRs. The yield varied among devices, with the autotrigger devices offering the highest range of detection (72-80%), followed by the patient-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 (Hoefman, 2010).
Ablation, as a treatment of AF, is an option in individuals with symptomatic AF, in individuals who are refractory or intolerant to pharmacologic management, and in selected individuals with heart failure (HF) and/or reduced left ventricular ejection fraction (LVEF). Catheter ablation of AF is addressed in MED.00064 Transcatheter Ablation of Arrhythmogenic Foci in the Pulmonary Veins as a Treatment of Atrial Fibrillation (Radiofrequency and Cryoablation). In 2007, the Heart Rhythm Society (HRS), in conjunction with other organizations, published a consensus statement addressing the follow-up of individuals undergoing ablative therapy for AF (HRS, 2007). This consensus statement pointed out that careful attention to anticoagulation therapy is needed, both before and after the ablative procedure, to avoid the occurrence of a thromboembolic event, which is considered one of the most serious complications of both AF and AF ablation procedures. For example, early recurrences of AF are common during the first one to three months following ablation, due to remodeling and healing. For this reason, monitoring to assess the efficacy of catheter ablation is typically delayed for at least three months, following the ablation. The consensus statement notes that monitoring options include intermittent sampling using a standard ECG, or the use of an AEM. However, the consensus does not indicate how this information can be used in the management of the individual, specifically whether or not to discontinue anticoagulation therapy. For example, the consensus statement provided the following recommendations for anticoagulation after ablation (these indications are not based on the presence or absence of AF):
The ACC/AHA/ESC Guidelines on the Management of AF address the role of ablation techniques, and note:
The long term efficacy of catheter ablation to prevent recurrent AF requires further study. Available data demonstrate 1 year or more free from recurrent AF in most (albeit, carefully selected) patients. It is important to bear in mind, however, that AF can recur without symptoms and be unrecognized by the patient or the physician. Therefore, it remains uncertain whether apparent cures represent elimination of AF or transformation into an asymptomatic form of paroxysmal AF. The distinction has important implications for the duration of anticoagulation treatment (Fuster, 2006).
A 2011 ACCF/AHA/HRS focused update to the ACC/AHA/ESC Guidelines on the Management of AF includes HM and longer term event recording in its recommendations for initial clinical evaluation if the diagnosis or type of arrhythmia is in question and also in subsequent treatment monitoring as a means of evaluating rate control and individual risk for thromboembolic events. This document reviews the major clinical trials of various treatment strategies for AF and notes, "The optimum method for monitoring antiarrhythmic drug treatment varies with the agent involved, as well as with patient factors." The following is excerpted:
Ambulatory ECG recordings and device-based monitoring have revealed that an individual may experience periods of both symptomatic and asymptomatic AF…Prolonged or frequent monitoring may be necessary to reveal episodes of asymptomatic AF, which may be a cause of cryptogenic stroke (Fuster, 2011).
In 2014, the AHA/ACC/HRS updated its Guidelines on the Management of Patients with Atrial Fibrillation which referred to ILR, pacemakers and defibrillators as, "Offer the possibility to report the frequency, rate, and duration of abnormal atrial rhythms including AF" (January, 2014). No additional information or recommendations for use of ILRs were provided in this document.
Based on the current knowledge base, there is inadequate data to support the use of AEMs in post-ablation therapy to determine the need for continued anticoagulation therapy.
The CARISMA study (Cardiac Arrhythmias and Risk Stratification After MyoCardial Infarction) investigated the incidence and prognostic significance of arrhythmias, documented by use of an ILR, in individuals following acute myocardial infarction (MI) with left ventricular systolic dysfunction. A total of 1393 of 5869 individuals (24%) screened in the acute phase (3 to 21 days) of an acute MI had left ventricular ejection fraction (LVEF) ≤ 40%. After exclusions, 297 subjects (21%) (mean ± SD age 64.0 ± 11.0 years; LVEF 31 ± 7%) received an ILR within 11 ± 5 days of the acute MI and were followed up every 3 months for an average of 1.9 ± 0.5 years. Predefined bradyarrhythmias and tachyarrhythmias were recorded in 137 subjects (46%); 86% of these were asymptomatic. The ILR documented a 28% incidence of new-onset atrial fibrillation with fast ventricular response (≥ 125 bpm), a 13% incidence of nonsustained ventricular tachycardia (≥ 16 beats), a 10% incidence of high-degree atrioventricular block (≤ 30 bpm lasting ≥ 8 seconds), a 7% incidence of sinus bradycardia (≤ 30 bpm lasting ≥ 8 seconds), a 5% incidence of sinus arrest (≥ 5 seconds), a 3% incidence of sustained ventricular tachycardia, and a 3% incidence of ventricular fibrillation. Cox regression analysis with time-dependent covariates revealed that high-degree atrioventricular block was the most powerful predictor of cardiac death (hazard ratio [HR], 6.75; 95% confidence interval, 2.55 to 17.84; P < 0.001). In this first study to report on long-term cardiac arrhythmias, recorded by an ILR in individuals with an LVEF ≤ 40% after MI, the authors concluded that clinically significant bradyarrhythmias and tachyarrhythmias were documented in a substantial proportion of study subjects with depressed LVEF after acute MI and that intermittent high-degree atrioventricular block was associated with a very high risk of cardiac death (Bloch, 2010).
A substudy of the CARISMA investigated the incidence and risk associated with new-onset AF occurring after discharge in subjects following an acute MI. This study included 271 post-MI subjects with an LVEF ≤ 40% and no history of previous AF. All trial subjects were implanted with an ILR and followed up every 3 months for 2 years. Major cardiovascular events were defined as reinfarction, stroke, hospitalization for heart failure, or death. Results showed the risk of new-onset AF is highest during the first 2 months after the acute MI (16% event rate) and decreases until month 12 post-MI, after which the risk for new-onset AF is stable. The risk of major cardiovascular events was increased in subjects with AF events ≥ 30 seconds (HR [95% CI] = 2.73 [1.35 to 5.50], P=0.005), but not in subjects with AF events lasting < 30 seconds (HR [95% CI] = 1.17 [0.35 to 3.92], P=.80). More than 90% of all recorded AF events were asymptomatic. The authors concluded that, through use of an ILR, the incidence of new-onset AF was found to be 4-fold higher than earlier reported. In the study population in which treatment with beta-blockers was optimized, the vast majority of AF events were asymptomatic, and a duration of 30 seconds or more identified clinically important AF episodes (Jons, 2011).
A systematic review and meta-analysis was conducted by Kishore to determine the frequency of newly detected AF using noninvasive or invasive cardiac monitoring after ischemic stroke or transient ischemic attack (TIA). Prospective observational studies or randomized controlled trials of individuals with ischemic stroke, TIA, or both, who underwent any cardiac monitoring for a minimum of 12 hours, were included after electronic searches of multiple databases. The primary outcome was detection of any new AF during the monitoring period. A total of 32 studies were analyzed. The overall detection rate of any AF was 11.5% (95% confidence interval, 8.9% - 4.3%), although the timing, duration, method of monitoring, and reporting of diagnostic criteria used for paroxysmal AF varied. Results showed that detection rates were higher in selected subjects (13.4%; 95% confidence interval, 9.0%-18.4%), as compared to unselected subjects (6.2%; 95% confidence interval, 4.4%-8.3%). The authors noted the presence of substantial heterogeneity even within specified subgroups. The investigators concluded that detection of AF was highly variable. This review was limited by small sample sizes and marked heterogeneity. Further studies are needed to inform appropriate subject selection, as well as optimal timing, methods, and duration of monitoring for detection of AF/paroxysmal AF (Kishore, 2014).
The Cryptogenic Stroke and underlying Atrial Fibrillation (CRYSTAL-AF) trial is a large, prospective, randomized controlled study, which was designed to evaluate the time to first episode of AF by means of six months of continuous rhythm monitoring versus control treatment in subjects with a recent cryptogenic stroke or TIA but without a personal history of AF. 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, the Reveal XT (Medtronic, Inc., Minneapolis, MN) (in the continuous monitoring arm). The primary end point is time to detection of AF within 6 months after stroke, and the clinical follow-up period will be at least 12 months. In January 2014, the CRYSTAL-AF trial was listed as completed on the Clinicaltrials.gov website. However, as of April 25, 2014, no trial results have been published other than a preliminary description of the trial design (Sinha, 2010).
Newer devices are becoming available with enhanced recording capability, such as the Zio®Patch (iRhythm Technologies, Inc., San Francisco, CA) which obtained FDA clearance in 2012 for, "Prescription only single patient use, continuous recording EGG monitor that can be worn for up to 14 days. It is indicated for use on patients who experience transient symptoms, such as syncope, palpitations, shortness of breath, or chest pains" (FDA, 2012). To date, the published evidence regarding these newer devices is limited regarding safety/efficacy and impact on clinical outcomes.
*The CHADS (cardiac failure, hypertension, age, diabetes, stroke) score is a risk assessment tool that is based on a point system, in which 2 points are assigned for a history of stroke or TIA, and 1 point each is assigned for age over 75 and a history of hypertension, diabetes or recent HF. The adjusted stroke rate can be assessed based on the CHADS score. For example, a CHADS score of 2 is associated with an adjusted stroke rate of 4% per year (Fuster, 2006).
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
Ambulatory Event Monitors
Cardiac Event Monitors/Loop Recorders
iRhythm Zio Patch
Reveal Plus Insertable Loop Recorder
Sleuth Implantable 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.
|Reviewed||05/15/2014||Medical Policy & Technology Assessment Committee (MPTAC) review. No change to criteria. The Discussion and References sections were updated.|
|Reviewed||05/09/2013||MPTAC review. No change to criteria. The Discussion section and References were updated.|
|Reviewed||05/10/2012||MPTAC review. No change to criteria. The Discussion section, Coding and References were updated. The number changed from CG-DME-29 to CG-MED-40.|
|Reviewed||05/19/2011||MPTAC review. No change to criteria. References and Websites updated.|
|01/01/2011||Updated Coding section with 01/01/2011 CPT changes; removed CPT 93012, 93014 deleted 12/31/2010.|
|Reviewed||05/13/2010||MPTAC review. No change to criteria. References were updated.|
|Revised||05/21/2009||MPTAC review. The indications considered not medically necessary for these devices have been expanded to add the following: following ablation procedures for atrial fibrillation and monitoring for atrial fibrillation in cryptogenic stroke. Discussion section, Coding and References were updated.|
|Reviewed||05/15/2008||MPTAC review. No change to criteria. References were updated.|
|10/01/2007||Updated Coding section with 10/01/2007 ICD-9 changes.|
|Reviewed||05/17/2007||MPTAC review. No change to guideline criteria. References and coding were updated.|
|Reviewed||06/08/2006||MPTAC review. No change to guideline criteria. References were updated to include scientific statements and guideline recommendations from the ACC/AHA. Guideline was renumbered to CG-DME-29 from former CG-MED-03.|
|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. Converted into a guideline.|
|Pre-Merger Organizations||Last Review Date||Document Number|
|Anthem, Inc.||No prior document|
|WellPoint Health Networks, Inc.||06/24/2004||9.04.02||Ambulatory Event Monitors to Detect Cardiac Arrhythmias|