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Page 1: 347 Ambulatory Event Monitors and Mobile Cardiac … · Ambulatory Event Monitors and Mobile Outpatient Cardiac ... monitors for cardiac monitoring include the Reveal® Insertable

Medical PolicyAmbulatory Event Monitors and Mobile Outpatient Cardiac Telemetry

Table of Contents Policy: Commercial Coding Information Information Pertaining to All Policies

Policy: Medicare Description References

Authorization Information Policy History

Policy Number: 347BCBSA Reference Number: 2.02.08

Related PoliciesNone

PolicyCommercial Members: Managed Care (HMO and POS), PPO, and Indemnity

The use of patient-activated or auto-activated external ambulatory event monitors may be MEDICALLYNECESSARY as a diagnostic alternative to Holter monitoring in the following situations: Patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of

cardiac arrhythmias (i.e., palpitations, dizziness, or syncope). Patients with atrial fibrillation who have been treated with catheter ablation, and in whom

discontinuation of systemic anticoagulation is being considered.

The use of implantable ambulatory event monitors either patient activated or auto-activated may beMEDICALLY NECESSARY only in the small subset of patients who experience recurrent symptoms soinfrequently that a prior trial of other external ambulatory event monitors has been unsuccessful.

Transtelephonic transmission of post-symptom electrocardiograms and cardiac event monitorsmay be MEDICALLY NECESSARY for the following indications, when used to evaluate patients inremote areas or long distances (such as 100 miles) from physicians capable of interpreting ECG: To detect, characterize, and document symptomatic transient arrhythmias To assess anti-arrhythmic drug efficiency, and To carry out early post-hospital monitoring of patients discharged after a myocardial infarction, if 24

hour coverage is provided. Such coverage must be performed by an experienced electrocardiogramtechnician receiving the calls (tapes and facsimiles do not count). These technicians must haveimmediate access to a physician, and have been instructed when and how to contact availablefacilities to assist the patient in case of emergencies.

This policy statement applies to plain EKGs (ECGs, electrocardiograms) only, transmittedelectronically for the purposes of interpretation, and

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Transmitting devices must be capable of transmitting ECG leads I, II, and III, and transmissions mustbe comparable to readings obtained by conventional ECGs, to permit proper interpretation ofabnormal cardiac rhythms.

NOTE: Facsimiles and tapes are not reimbursed.

Outpatient cardiac telemetry (also known as mobile cardiac outpatient telemetry or MCOT) is NOT

MEDICALLY NECESSARY.

Continuous ambulatory monitors that record and store information for periods longer than 48 hours areINVESTIGATIONAL.

Other uses of ambulatory event monitors (including outpatient cardiac telemetry), including, but notlimited to, monitoring effectiveness of antiarrhythmic medications, for patients with cryptogenic stroke, anddetection of myocardial ischemia by detecting ST segment changes are INVESTIGATIONAL.

Medicare HMO BlueSM and Medicare PPO BlueSM MembersAmbulatory event monitoring, mobile outpatient cardiac telemetry and transtelephonic transmission ofpost-symptom electrocardiograms, and cardiac event monitors is covered for the following indications: To detect, characterize, and document symptomatic transient arrhythmias, To initiate, revise, or discontinue arrhythmic drug therapy, or To carry out early post-hospital monitoring of patients discharged after myocardial infarction (mobile

cardiac telemetry with real-time transmission, analysis, and response must be used for thisindication).

Ambulatory event monitoring, mobile outpatient cardiac telemetry and transtelephonic transmission ofpost-symptom electrocardiograms, and cardiac event monitors is not covered for any other indicationsthan those noted in the previous section.

Prior Authorization InformationSee below for situations where prior authorization may be required or may not be required.Yes indicates that prior authorization is required.No indicates that prior authorization is not required.

Outpatient InpatientCommercial Managed Care (HMO and POS) No n/aCommercial PPO and Indemnity No n/a

Medicare HMO BlueSM

No n/aMedicare PPO Blue

SMNo n/a

Other Information: Interpretation of the transmitted telephonic electrocardiogram must be performed by a Blue Cross

Blue Shield of Massachusetts contracted Cardiologist when referred for interpretation by a physician. Transmission of a telephonic electrocardiogram, when performed by an independent

physiological/diagnostic laboratory, must be rendered by a Blue Cross Blue Shield contractedIndependent Physiological/Diagnostic Lab.

CPT Codes / HCPCS Codes / ICD-9 CodesThe following codes are included below for informational purposes. Inclusion or exclusion of a code doesnot constitute or imply member coverage or provider reimbursement. Please refer to the member’scontract benefits in effect at the time of service to determine coverage or non-coverage as it applies to anindividual member. A draft of future ICD-10 Coding related to this document, as it might look today, isincluded below for your reference.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, anddiagnosis codes, including modifiers where applicable.

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CPT Codes

CPT codes: Code Description33282 Implantation of patient-activated cardiac event monitor33284 Removal of an implantable, patient-activated cardiac event recorder93228 Wearable mobile cardiovascular telemetry with electrocardiographic recording,

concurrent computerized real time data analysis and greater than 24 hours ofaccessible ECG data storage (retrievable with query) with ECG triggered and patientselected 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 ofaccessible ECG data storage (retrievable with query) with ECG triggered and patientselected 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 rhythmderived event recording with symptom-related memory loop with remote downloadcapability up to 30 days, 24-hour attended monitoring; includes transmission, physicianreview and interpretation

93270 External patient and, when performed, auto activated electrocardiographic rhythmderived event recording with symptom-related memory loop with remote downloadcapability up to 30 days, 24-hour attended monitoring; recording (includes connection,recording, and disconnection)

93271 External patient and, when performed, auto activated electrocardiographic rhythmderived event recording with symptom-related memory loop with remote downloadcapability up to 30 days, 24-hour attended monitoring; transmission and analysis

93272 External patient and, when performed, auto activated electrocardiographic rhythmderived event recording with symptom-related memory loop with remote downloadcapability up to 30 days, 24-hour attended monitoring; physician review andinterpretation

0295T External electrocardiographic recording for more than 48 hours up to 21 days bycontinuous rhythm recording and storage; includes recording, scanning analysis withreport, review and interpretation

0296T External electrocardiographic recording for more than 48 hours up to 21 days bycontinuous rhythm recording and storage; recording (includes connection and initialrecording)

0297T External electrocardiographic recording for more than 48 hours up to 21 days bycontinuous rhythm recording and storage; scanning analysis with report

0298T External electrocardiographic recording for more than 48 hours up to 21 days bycontinuous rhythm recording and storage; review and interpretation

ICD-9 Diagnosis Codes

ICD-9-CMdiagnosiscodes: Code Description426.9 Unspecified conduction disorder427.31 Atrial fibrillation427.60 Premature beats, unspecified427.89 Other specified cardiac dysrhythmias427.9 Cardiac dysrhythmia, unspecified780.2 Syncope and collapse780.4 Dizziness and giddiness

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785.1 Palpitations

ICD-10 Diagnosis CodesICD-10-CMDiagnosiscodes: Code Description

I45.9 Conduction disorder, unspecified

I48.0 Paroxysmal atrial fibrillation

I48.2 Chronic atrial fibrillation

I48.91 Unspecified atrial fibrillation

I49.40 Unspecified premature depolarization

I49.8 Other specified cardiac arrhythmias

I49.9 Cardiac arrhythmia, unspecified

R00.1 Bradycardia, unspecified

R00.2 Palpitations

R42 Dizziness and giddiness

R55 Syncope and collapse

DescriptionAmbulatory Holter electrocardiography (EKG) is a widely used noninvasive test in which EKG iscontinuously recorded over an extended period of time, typically 24 to 48 hours, to evaluate symptomssuggestive of cardiac arrhythmias (i.e., palpitations, dizziness, or syncope). However, Holter monitoringwill be ineffective if a patient experiences infrequent symptoms. Ambulatory event monitors (AEMs) weredeveloped to provide longer periods of monitoring. In this technique, the recording device is either worncontinuously and activated only when the patient experiences symptoms, or carried by the patient andapplied and activated when symptoms are present. The recorded EKGs are then stored for futureanalysis or transmitted by telephone to a receiving station where the EKGs can then be analyzed. AEMscan be used for extended periods of time, typically up to a month until the patient experiences symptoms.Since the EKGs are recorded only during symptoms, there is good correlation with any underlyingarrhythmia. Conversely, if no EKG abnormality is noted, a noncardiac etiology of the patient's symptomscan be sought.

Several different types of AEMs are available:

Noncontinuous devices with memoryThese devices are carried by the patient and applied to the precordial area via nongel electrodes whenthe symptoms are occurring or, alternatively, a recording device may be worn on the wrist and thenactivated when symptoms are present. The limitation of these devices is that an arrhythmia of very shortduration would be difficult to record. In addition, noncontinuous devices require reasonable dexterity onthe part of the patient to apply the device correctly during a symptomatic period. This is a particularlimitation if the patient is incapacitated during symptomatic periods.

Continuous "memory loop" devicesThese sophisticated devices are worn continuously and are able to continuously store a single channel ofEKG data in a refreshed memory. If the patient activates the device, the EKG is then recorded from thememory loop for the preceding 30 to 90 seconds, and for the next minute or so. Therefore, these types ofdevices permit recording of the onset of arrhythmias and/or transient or incapacitating events.

Implantable continuous “memory loop” devicesAn implantable loop recorder device is inserted just under the patient’s skin in the chest area during anoutpatient surgical procedure and can be used for more than 1 year. When symptoms are felt, the patientplaces a hand-held activator over the recorder to activate the storage of cardiac rhythm.

Auto-triggered devicesAll of these devices require activation by the patient. More recently, auto-triggering technology hasbecome available, which can be adapted to memory loop devices. For example, event monitors can be

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programmed to detect heart rates greater than 165 beats per minute, less than 40 beats per minute, or anasystole of greater than 3 seconds.

Mobile Cardiac Outpatient TelemetryAmbulatory event monitors store the recorded data, which are ultimately transmitted either to aphysician’s office or to a central recording station. In contrast, outpatient cardiac telemetry provides real-time monitoring and analysis. The referring physician can request the level and timing of response,ranging from daily reports to stat results.

Examples of ambulatory event monitors for cardiac monitoring include the Reveal® Insertable LoopRecorder from Medtronic the HEARTLink II system from Cardiac Telecom Corp., and the VST (Vital SignsTransmitter from Biowatch Medical. All ambulatory event monitors for cardiac monitoring are consideredinvestigational regardless of the commercial name, the manufacturer, or FDA approval status except asnoted in the policy statement.

SummaryA number of studies have indicated that autotrigger event monitors detect additional episodes ofarrhythmias compared to Holter monitoring or patient-triggered devices. This evidence has led to theacceptance of autotrigger event monitors as the gold standard for detecting arrhythmias that occurinfrequently. There is also evidence that autotrigger devices can pick up asymptomatic episodes of atrialfibrillation in patients treated with catheter ablation and that identifying asymptomatic episodes may leadto modifications in treatment. For patients with cryptogenic stroke, longer monitoring periods will detectadditional episodes of atrial fibrillation, but the evidence is not sufficient to conclude that outcomes areimproved.

Newer continuous monitoring devices are available that use novel technology and record information forlonger periods than a Holter monitor, eg, up to 2 weeks. There is a lack of evidence on the quality ofrecording from these devices, and on the detection rate for cardiac arrhythmias. Due to a lack ofevidence, these continuous monitoring devices that record for longer time periods are consideredinvestigational.

Mobile cardiac outpatient telemetry (MCOT) is another option for long-term cardiac monitoring. Thecurrent evidence on MCOT establishes that it does record cardiac electric signals, without patientactivation, for subsequent analysis. Currently, the literature does not provide any adequate comparativedata for MCOT compared to the autotrigger device. One retrospective, uncontrolled study reported thatonly a small minority of events (1%) detected by MCOT were potentially emergent. None of the availablestudies have clearly shown an improvement in clinical utility as a result of using MCOT. Further studiesare needed to compare MCOT with the autotrigger loop recorder in order to determine whether the fasterresponse possible with real-time monitoring leads to improved outcomes.

Thus, at the present time, outcomes from use of a MCOT are expected to be equivalent to outcomes fromuse of autotrigger or other types of devices. As a result, in situations where MCOT is more expensivethan alternate devices such as the autotrigger device, MCOT is considered not medically necessary.

Policy HistoryDate Action7/2014 Updated Coding section with ICD10 procedure and diagnosis codes, effective 10/2015.6/2014 Language on MCOT clarified4/2014 BCBSA National medical policy review.

Revised to change “loop monitors” to “ambulatory event monitors” and add “The policystatement on outpatient cardiac telemetry was reworded and language was added thatthe least costly alternative may be considered medically necessary.” Effective 4/1/2014.

3/2014 BCBSA National medical policy review.Medically necessary criteria for implantable loop monitors revised from “…a prior trial ofHolter monitor and other external ambulatory event monitors has been unsuccessful” to“…a prior trial of other external ambulatory event monitors has been unsuccessful.”

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Effective 3/1/2014.1/2014 New references added from BCBSA National medical policy.6/1/2013 BCBSA National medical policy review.

Changes to policy statements.11/2011-4/2012

Medical policy ICD 10 remediation: Formatting, editing and coding updates.No changes to policy statements.

4/2011 Reviewed - Medical Policy Group - Cardiology and Pulmonology.No changes to policy statements.

10/2010 BCBSA National medical policy review.Changes to policy statements.

4/2010 Reviewed - Medical Policy Group - Cardiology and Pulmonology.No changes to policy statements.

12/31/2009 BCBSA National medical policy review.Changes to policy statements.

7/2009 BCBSA National medical policy review.Changes to policy statements.

4/2009 Reviewed - Medical Policy Group - Cardiology and Pulmonology.No changes to policy statements.

3/2009 BCBSA National medical policy review.No changes to policy statements.

4/2008 Reviewed - Medical Policy Group - Cardiology and Pulmonology.No changes to policy statements.

11/2007 BCBSA National medical policy review.No changes to policy statements.

6/2007 BCBSA National medical policy review.No changes to policy statements.

5/2007 BCBSA National medical policy review.Changes to policy statements.

4/2007 Reviewed - Medical Policy Group - Cardiology and Pulmonology.No changes to policy statements.

Information Pertaining to All Blue Cross Blue Shield Medical PoliciesClick on any of the following terms to access the relevant information:Medical Policy Terms of UseManaged Care GuidelinesIndemnity/PPO GuidelinesClinical Exception ProcessMedical Technology Assessment Guidelines

References1. DiMarco JP, Philbrick JT. Use of ambulatory electrocardiographic (Holter) monitoring. Ann Intern Med

1990; 113(1):53-68.2. Hoefman E, Bindels PJ, van Weert HC. Efficacy of diagnostic tools for detecting cardiac arrhythmias:

systematic literature search. Neth Heart J 2010; 18(11):543-51.3. Turakhia MP, Hoang DD, Zimetbaum P et al. Diagnostic utility of a novel leadless arrhythmia

monitoring device. Am J Cardiol 2013; 112(4):520-4.4. 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, or syncope. ClinCardiol 2003; 26(4):173-6.

5. Ermis C, Zhu AX, Pham S et al. Comparison of automatic and patient-activated arrhythmia recordingsby implantable loop recorders in the evaluation of syncope. Am J Cardiol 2003; 92(7):815-9.

6. Reiffel JA, Schwarzberg R, Murry M. Comparison of autotriggered memory loop recorders versusstandard loop recorders versus 24-hour Holter monitors for arrhythmia detection. Am J Cardiol 2005;95(9):1055-9.

Page 7: 347 Ambulatory Event Monitors and Mobile Cardiac … · Ambulatory Event Monitors and Mobile Outpatient Cardiac ... monitors for cardiac monitoring include the Reveal® Insertable

7. Ng E, Stafford PJ, Ng GA. Arrhythmia detection by patient and auto-activation in implantable looprecorders. J Interv Card Electrophysiol 2004; 10(2):147-52.

8. Hindricks G, Pokushalov E, Urban L et al. Performance of a new leadless implantable cardiac monitorin detecting and quantifying atrial fibrillation: Results of the XPECT trial. Circ Arrhythm Electrophysiol2010; 3(2):141-7.

9. Hanke T, Charitos EI, Stierle U et al. Twenty-four-hour holter monitor follow-up does not provideaccurate heart rhythm status after surgical atrial fibrillation ablation therapy: up to 12 monthsexperience with a novel permanently implantable heart rhythm monitor device. Circulation 2009;120(11 Suppl):S177-84.

10. Da Costa A, Defaye P, Romeyer-Bouchard C et al. Clinical impact of the implantable loop recorder inpatients with isolated syncope, bundle branch block and negative workup: a randomized multicentreprospective study. Arch Cardiovasc Dis 2013; 106(3):146-54.

11. Leshem-Rubinow E, Berger M, Shacham J et al. New real-time loop recorder diagnosis ofsymptomatic arrhythmia via telemedicine. Clin Cardiol 2011; 34(7):420-5.

12. Sankari Z, Adeli H. HeartSaver: a mobile cardiac monitoring system for auto-detection of atrialfibrillation, myocardial infarction, and atrio-ventricular block. Comput Biol Med 2011; 41(4):211-20.

13. Joshi AK, Kowey PR, Prystowsky EN et al. First experience with a Mobile Cardiac OutpatientTelemetry (MCOT) system for the diagnosis and management of cardiac arrhythmia. Am J Cardiol2005; 95(7):878-81.

14. Olson JA, Fouts AM, Padanilam BJ et al. Utility of mobile cardiac outpatient telemetry for thediagnosis of palpitations, presyncope, syncope, and the assessment of therapy efficacy. J CardiovascElectrophysiol 2007; 18(5):473-7.

15. Saarel EV, Doratotaj S, Sterba R. Initial experience with novel mobile cardiac outpatient telemetry forchildren and adolescents with suspected arrhythmia. Congenital heart disease 2008; 3(1):33-8.

16. Tayal AH, Tian M, Kelly KM et al. Atrial fibrillation detected by mobile cardiac outpatient telemetry incryptogenic TIA or stroke. Neurology 2008; 71(21):1696-701.

17. 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 eventmonitoring. J Cardiovasc Electrophysiol 2007; 18(3):241-7.

18. Kadish AH, Reiffel JA, Clauser J et al. Frequency of serious arrhythmias detected with ambulatorycardiac telemetry. Am J Cardiol 2010; 105(9):1313-6.

19. Dagres N, Kottkamp H, Piorkowski C et al.:Influence of the duration of Holter monitoring on thedetection of arrhythmia recurrences after catheter ablation of atrial fibrillation: implications for patientfollow-up. Int J Cardiol 2010; 139(3):305-6.

20. Pokushalov E, Romanov A, Corbucci G et al. Ablation of paroxysmal and persistent atrial fibrillation:1-year follow-up through continuous subcutaneous monitoring. J Cardiovasc Electrophysiol 2011;22(4):369-75.

21. Chao TF, Lin YJ, Tsao HM et al. CHADS(2) and CHA(2)DS(2)-VASc scores in the prediction ofclinical outcomes in patients with atrial fibrillation after catheter ablation. J Am Coll Cardiol 2011;58(23):2380-5.

22. Themistoclakis S, Corrado A, Marchlinski FE et al. The risk of thromboembolism and need for oralanticoagulation after successful atrial fibrillation ablation. J Am Coll Cardiol 2010; 55(8):735-43.

23. Mittal S, Movsowitz C, Steinberg JS. Ambulatory external electrocardiographic monitoring: focus onatrial fibrillation. J Am Coll Cardiol 2011; 58(17):1741-9.

24. Gumbinger C, Krumsdorf U, Veltkamp R et al. Continuous monitoring versus HOLTER ECG fordetection of atrial fibrillation in patients with stroke. Eur J Neurol 2012; 19(2):253-7.

25. Lazzaro MA, Krishnan K, Prabhakaran S. Detection of atrial fibrillation with concurrent holtermonitoring and continuous cardiac telemetry following ischemic stroke and transient ischemic attack.J Stroke Cerebrovasc Dis 2012; 21(2):89-93.

26. Cotter PE, Martin PJ, Ring L et al. Incidence of atrial fibrillation detected by implantable looprecorders in unexplained stroke. Neurology 2013; 80(17):1546-50.

27. Miller DJ, Khan MA, Schultz LR et al. Outpatient cardiac telemetry detects a high rate of atrialfibrillation in cryptogenic stroke. J Neurol Sci 2013; 324(1-2):57-61.

28. Kamel H, Navi BB, Elijovich L et al. Pilot randomized trial of outpatient cardiac monitoring aftercryptogenic stroke. Stroke 2013; 44(2):528-30.

Page 8: 347 Ambulatory Event Monitors and Mobile Cardiac … · Ambulatory Event Monitors and Mobile Outpatient Cardiac ... monitors for cardiac monitoring include the Reveal® Insertable

29. 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.

30. Sinha AM, Diener HC, Morillo CA et al. Cryptogenic Stroke and underlying Atrial Fibrillation(CRYSTAL AF): design and rationale. Am Heart J 2010; 160(1):36-41 e1.

31. Crawford MH, Bernstein SJ, Deedwania PC et al. ACC/AHA Guidelines for AmbulatoryElectrocardiography. A report of the American College of Cardiology/American Heart AssociationTask Force on Practice Guidelines (Committee to Revise the Guidelines for AmbulatoryElectrocardiography). Developed in collaboration with the North American Society for Pacing andElectrophysiology. J Am Coll Cardiol 1999; 34(3):912-48.

32. Zimetbaum PJ, Josephson ME. The evolving role of ambulatory arrhythmia monitoring in generalclinical practice. Ann Intern Med 1999; 130(10):848-56.

33. Calkins H, Kuck KH, Cappato R et al. 2012 HRS/EHRA/ECAS expert consensus statement oncatheter and surgical ablation of atrial fibrillation: recommendations for patient selection, proceduraltechniques, patient management and follow-up, definitions, endpoints, and research trial design. JInterv Card Electrophysiol 2012; 33(2):171-257.