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OUTPATIENT CARDIOVASCULAR TELEMETRY

Protocol: CAR036 Effective Date: August 16, 2010 Table of Contents Page

COMMERCIAL COVERAGE RATIONALE......................................................................................... 1 MEDICARE & MEDICAID COVERAGE RATIONALE...................................................................... 2 BACKGROUND ...................................................................................................................................... 7 CLINICAL EVIDENCE........................................................................................................................... 8 U.S. FOOD AND DRUG ADMINISTRATION.................................................................................... 11 APPLICABLE CODES .......................................................................................................................... 12 REFERENCES ....................................................................................................................................... 12 PROTOCOL HISTORY/REVISION INFORMATION ........................................................................ 14

INSTRUCTIONS FOR USE This protocol provides assistance in interpreting UnitedHealthcare benefit plans. When deciding coverage, the enrollee specific document must be referenced. The terms of an enrollee's document (e.g., Certificate of Coverage (COC) or Evidence of Coverage (EOC)) may differ greatly. In the event of a conflict, the enrollee's specific benefit document supersedes this protocol. All reviewers must first identify enrollee eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this Protocol. Other Protocols, Policies and Coverage Determination Guidelines may apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its Protocols, Policies and Guidelines as necessary. This protocol is provided for informational purposes. It does not constitute medical advice.

COMMERCIAL COVERAGE RATIONALE Outpatient cardiovascular telemetry is not medically necessary for managing cardiac arrhythmias. These devices (e.g. Cardionet®, HEARTLinkTM II, LifeStar ACT) record and interpret heart rhythms continuously, allow automatic ECG-triggered transmissions to a remote attended surveillance center and do not require patient interaction to transmit data. There is insufficient evidence in the clinical literature to conclude that auto-triggered transmissions and remote surveillance demonstrate improvement in clinical outcomes. Published clinical evidence does demonstrate improvement in clinical outcomes in the management of atrial fibrillation with the use of standard event monitoring.

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MEDICARE & MEDICAID COVERAGE RATIONALE Medicare has a National Coverage Determination for Electrocardiographic Services. The National Coverage Determination is as follows: A. The following indications are covered nationally as medically necessary unless otherwise indicated: 1. Computer analysis of EKGs when furnished in a setting and under the circumstances required for coverage of other EKG services. 2. EKG services rendered by an independent diagnostic testing facility (IDTF), including physician review and interpretation. Separate physician services are not covered unless he/she is the patient's attending or consulting physician. 3. Emergency EKGs (i.e., when the patient is or may be experiencing a lifethreatening event) performed as a laboratory or diagnostic service by a portable x-ray supplier only when a physician is in attendance at the time the service is performed or immediately thereafter. 4. Home EKG services with documentation of medical necessity. 5. Trans-telephonic EKG transmissions as a diagnostic service for the indications described below, when performed with equipment meeting the standards described below, subject to the limitations and conditions specified below. Coverage is further limited to the amounts payable with respect to the physician's service in interpreting the results of such transmissions, including charges for rental of the equipment. The device used by the beneficiary is part of a total diagnostic system and is not considered DME separately. Covered uses are to: a. Detect, characterize, and document symptomatic transient arrhythmias; b. Initiate, revise, or discontinue arrhythmic drug therapy; or, c. Carry out early post-hospital monitoring of patients discharged after myocardial infarction (MI); (only if 24-hour coverage is provided, see B.5. below). Certain uses other than those specified above may be covered if, in the judgment of the local contractor, such use is medically necessary. Additionally, the transmitting devices must meet at least the following criteria: 1. They must be capable of transmitting EKG Leads, I, II, or III; and, 2. The tracing must be sufficiently comparable to a conventional EKG. 24-hour attended coverage used as early post-hospital monitoring of patients discharged after MI is only covered if provision is made for such 24-hour attended coverage in the manner described below: 24-hour attended coverage means there must be, at a monitoring site or central data center, an EKG technician or other non-physician, receiving calls and/or EKG data; tape recording devices do not meet this requirement. Further, such technicians should have immediate, 24-hour access to a physician to review transmitted data and make clinical decisions regarding the patient. The technician should also

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be instructed as to when and how to contact available facilities to assist the patient in case of emergencies. B. Nationally Non-covered Indications The following indications are non-covered nationally unless otherwise specified below: 1. The time-sampling mode of operation of ambulatory EKG cardiac event monitoring/recording. 2. Separate physician services other than those rendered by an IDTF unless rendered by the patient's attending or consulting physician. 3. Home EKG services without documentation of medical necessity. 4. Emergency EKG services by a portable x-ray supplier without a physician in attendance at the time of service or immediately thereafter. 5. 24-hour attended coverage used as early post-hospital monitoring of patients discharged after MI unless provision is made for such 24-hour attended coverage in the manner described in section A.5. above. 6. Any marketed Food and Drug Administration (FDA)-approved ambulatory cardiac monitoring device or service that cannot be categorized according to the framework below. C. Other Ambulatory cardiac monitoring performed with a marketed, FDA-approved device, is eligible for coverage if it can be categorized according to the framework below. Unless there is a specific NCD for that device or service, determination as to whether a device or service that fits into the framework is reasonable and necessary is according to local contractor discretion. Electrocardiographic Services Framework Pre-symptom memory loop o Insertable o Non-insertable Post-symptom (no memory loop)

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Patient/Event-Activated \ Intermittent Recorders

Attended Non-attended

__ Non-attended

__ Dynamic Electrocardiography

Non-Activated Continuous Recorders (e.g., Holter

TM

Monitor)

__

Non-attended

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There is a Local Coverage Determination for Nevada for Cardiac Event Detection. The local Coverage Determination is as follows: Cardiac Event Detection (CED) involves the use of a long-term monitor by patients to document a suspected or paroxysmal dysrhythmia. Following the recording of events, the patient transmits data via telephone to a physician's office, hospital facility, Independent Diagnostic Testing Facility (IDTF), or other specified station that is equipped and staffed to assess electrocardiographic data and to initiate appropriate management action. The device must be patient or event activated. The services included in this LCD require a 24-hour attended monitoring station to receive transmissions, and that the devices: 1. are patient/event activated and intermittently record cardiac arrhythmic events; 2. provide either pre-symptom memory loop or post-symptom recording; and 3. are non-insertable (non-implanted). A single service includes all recordings, transmissions and interpretations during a continuous 30-day period. Ambulatory outpatient cardiac telemetry (outpatient cardiac monitoring) services are included among the cardiac event detection type of ambulatory EKG monitoring services. Cardiac event detection is medically necessary for: 1. Detection, characterization, and documentation of symptomatic transient arrhythmias, when the frequency of the symptoms is limited and use of a 24-hour ambulatory EKG is unlikely to capture and document the arrhythmia; 2. Regulation of antiarrhythmic drug dosage, when needed to assess efficacy of treatment; 3. To monitor patients who have had surgical or ablative procedures for arrhythmias; Although the service is a 30-day service, it is recognized that the event recorder may be discontinued once the symptom-producing arrhythmia has been documented and diagnosed or following multiple transmissions during symptoms, without arrhythmia. It is unlikely that the arrhythmias would always be diagnosed on the first day of recording, or that the service would always last only one day. The average duration of monitoring is anticipated to last 10-14 days, or more. Limitations: 1. A CED service is medically unnecessary if it offers little or no potential for new clinical data beyond that which has been obtained from a previous test, (e.g., a standard electrocardiogram has already established a diagnosis), or if other tests are better suited to obtain the clinical data relevant to the patient's condition. The CED should be coordinated with results from standard EKGs, Holter monitor tests, and stress tests. 2. The receiving station must be staffed on a 24-hour basis with personnel trained to read EKGs (e.g., critical care nurses or paramedics), who should be able to direct the patient for the management of all emergencies. An answering service/answering machine would not fulfill this requirement.

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3. Systems utilizing computers to dial the physician's office so the physician receives transmission by way of a relay are not covered since there is no 24-hour personnel attendance. 4. A test not ordered by a physician or qualified nonphysician practitioner treating the beneficiary will be denied as not medically necessary. 5. The purpose of CED is the long term monitoring of patients to document a suspected or paroxysmal dysrhythmia. Therefore, it is considered medically unnecessary to utilize a CED service when only a standard EKG or EKG rhythm strip is required (even if it is used to transmit that EKG or rhythm strip to another location. 6. It is expected that CEDs would not be used for the routine daily transmission of EKG rhythm strips, or monitoring, in the absence of identified symptoms necessitating diagnosis as stated in this LCD. 7. Event recorders are covered only as diagnostic tests or for evaluating a patient being actively managed on arrhythmic medication. 8. Cardiac event detection is not covered for patients in hospitals, emergency rooms, skilled nursing facilities or other specialized facilities and will be denied as not medically necessary. 9. Cardiac event detection is not covered for either outpatient or facility-based cardiac monitoring. 10. Cardiac event detection is a 30-day service for the purpose of documentation and diagnosis of paroxysmal or suspected arrhythmias. The performance of this test is predicated by the pre-test incidence of symptoms related to arrhythmias and is considered not medically necessary for those patients who are not having significant recurrent arrhythmias which are anticipated to require treatment. 11. Testing for more than 30 consecutive days is only rarely medically necessary, and the need for the continued testing must be justified by the treating physician. Failure to document an arrhythmia during a 30-day test period is not sufficient justification to reimburse a second or subsequent test. It is unlikely to be medically necessary to repeat a second test within a year in the absence of new or recurrent undiagnosed symptoms. 12. Event recorders may be patient activated, and may not use time-sampling technology. Accordingly, this test will be considered medically unnecessary for any patient who is unresponsive, comatose, severely confused or otherwise unable to recognize symptoms, or activate the recorder (patient activated devices) or unable to participate in the use of the device. 13. Event recorders are not covered for outpatient monitoring of recently discharged post-infarct patients, and will be denied as not medically necessary. 14. "Routine" continued monitoring in the absence of treatable symptoms is considered screening and is not medically necessary. 15. Because the cardiac event detection service requires the diagnosis and evaluation of intermittent arrhythmias, and patients must be continuously attached to pre-symptom loop recorders or be able to be attached at the start of symptoms to post-symptom loop recorders, each patient is required to have a recorder for his/her own exclusive use throughout the duration of the monitoring period. Recorders may not be "shared" amongst two or more patients, regardless of the environment or site of the service. Claims for CED will be denied as not medically necessary when patients do not have exclusive use of a recorder for the entire service period (30 days). 16. Cardiac event detection is a 30-day packaged service. Tests may not be billed within 30 days of each other, even if the earlier of the tests was discontinued when arrhythmias were documented and the patient is now reconnected for follow-up of therapy or intervention.

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There is a Local Coverage Determination for Nevada for Dynamic Electrocardiography (EKG, ECG). The Local Coverage Determination is as follows: Dynamic electrocardiography (e.g. HolterTM monitoring) is the continuous 24-hour recording of an electrocardiogram rhythm strip. The recording is captured on magnetic tape or digitized medium. The data can then be computer-analyzed at a later time, using one of the following methods: · visual superimposition scanning of the entire recording or "page review" of the entire recording with selective sampling of rhythm strips (CPT codes 93224-93227); or · miniaturized printout of the entire recording with microprocessor-based analysis and selective sampling of rhythm strips (CPT codes 93230-93233); and/or · printout of microprocessor-selected EKG rhythm strips from analysis of the "real time" recordings (CPT codes 93235-93237). A physician reviews and interprets the computer generated report. Indications for which dynamic electrocardiography is medically necessary include any one or more of the following: 1. Detection of transient episodes of cardiac dysrhythmias, permitting correlation of these episodes with current cardiovascular symptomology, and or 2. Evaluation of the patient with symptoms of obscure etiology suggestive of cardiac arrhythmias, and/or 3. Detection of abnormalities of cardiac rhythm or electrocardiographic morphology associated with symptoms of syncope, near-syncope, palpitation, chest pain suggestive of cardiac ischemia, and shortness of breath on exertion, and/or 4. Evaluation of arrhythmias in the patient with documented coronary artery disease, including the assessment of the immediate post-myocardial infarction patient, and/or 5. Detection of arrhythmias (such as atrial fibrillation) in patients with acute stroke or TIAs, and/or 6. Assessment of patients with implanted pacemakers or defibrillators, but only when patients have symptoms suggestive of arrhythmia not revealed by the standard EKG or defibrillator event recordings, or by analysis of the pacemaker or defibrillator devices, and/or 7. Monitoring the effectiveness of antiarrhythmic therapy. Limitations: 1. Dynamic EKG recorders are not covered for the detection of silent ischemia, (i.e., patients without angina or symptoms suggestive of ischemia). 2. Tests performed in the absence of signs, symptoms or complaints consistent with arrhythmias or cardiac ischemia are, and will be denied as, not medically necessary. 3. The scanning of the 24-hour recording must be performed by personnel trained and credentialed to read EKGs (e.g., physicians, critical care nurses, paramedics, medical technicians, etc) or the service will be denied as not medically necessary. 4. Dynamic electrocardiography will be determined to be medically unnecessary if its use offers little or no potential for new clinical data beyond that which has been obtained (e.g., a standard electrocardiogram has already established a diagnosis), or if other tests are better suited to obtain the clinical data relevant to the patient's condition.

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Note: The recording device furnished to the patient is only one component of the diagnostic system and may not be billed separately under any circumstances (including as a DME).

For Medicare and Medicaid Determinations Related to States Outside of Nevada: Please review Local Coverage Determinations that apply to other states outside of Nevada. http://www.cms.hhs.gov/mcd/search Important Note: Please also review local carrier Web sites in addition to the Medicare Coverage database on the Centers for Medicare and Medicaid Services' Website.

BACKGROUND Cardiac arrhythmias are abnormal heart rhythms that can cause palpitations, weakness, dizziness, fainting, blood clots or death. However, some are asymptomatic. A variety of treatments have been developed for arrhythmias; however, selection of the appropriate treatment requires an accurate diagnosis, which may be difficult since arrhythmias can occur infrequently and unpredictably and may not cause obvious symptoms (Hayes, 2008). The type and duration of ambulatory electrocardiography (ECG) monitoring is dictated by the frequency of symptoms. Holter monitors are portable devices that record heart rhythms continuously for up to 48 hours. These devices are used to record events that occur at least once a day. Non-implantable cardiac event monitors are portable devices that record heart rhythms intermittently for up to 30 days. These devices capture ECG data before, during and after the time of activation. Standard loop recorders have just a few minutes of memory. Newer, more sophisticated devices have extended memory features that can store up to several hours of ECG data. Recording can be patient-activated when symptoms occur or automatically triggered based on a computer algorithm designed to detect arrhythmias. These devices are used to record infrequent or irregular events. Wearable outpatient cardiac telemetry devices continuously record heart rhythms from external electrodes placed on the patient's body. The devices can record for up to several weeks, if necessary. Segments of the ECG data are automatically (without patient intervention) transmitted to a remote monitoring center by cellular or standard telephone signals. The segments of the ECG selected for transmission are triggered automatically by preprogrammed algorithms or by the patient when experiencing symptoms. There is continuous real-time data analysis and attended surveillance of the transmitted information by a technician. The technician reviews the data and notifies the physician based on predefined criteria (AMA 2009a). These devices are used to record suspected asymptomatic arrhythmias. The American Medical Association (AMA) defines attended surveillance as the immediate availability of a remote technician to respond to rhythm or device alert transmissions from a patient, either from an implanted or wearable monitoring or therapy device, as they are generated and transmitted to the remote surveillance center (AMA 2009a).

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CLINICAL EVIDENCE The scope and quality of clinical studies found during a literature search of eCardio Diagnostics services for monitoring arrhythmias were insufficient to conduct an evidence-based assessment of safety and efficacy. No recommendation regarding adoption or use of this technology can be offered at this time (Hayes, 2009). A systematic review of the literature on remote cardiac monitoring concluded that patients with unexplained syncope or severe palpitations occurring less than once per 24 hours are more likely to undergo a change in disease management when using real-time continuous attended monitoring than when using conventional assessment (i.e. Holter monitoring and/or tilt table testing). However, the authors acknowledged that, because this conclusion is based on a single multicenter study, the strength of the evidence is weak (AHRQ, 2007). Results of studies suggest that mobile cardiac outpatient telemetry (MCOT) provides more effective detection of infrequent cardiac arrhythmias than external loop monitors. Information provided by MCOT has been used to guide patient management; however, only two uncontrolled studies reported changes in patient management based on the diagnostic information from MCOT. Moreover, none of the available studies involved follow-up or subsequent monitoring to determine whether patient outcomes improved as a result of changes in management based on information from MCOT. The three largest studies were sponsored and performed in part by CardioNet Inc. Further studies are needed to compare MCOT with autotriggered loop monitors and to determine whether diagnostic information obtained with MCOT improves patient outcomes as a result of appropriate changes in patient management (Hayes, 2008; updated 2009). A large multicenter randomized, controlled trial was conducted by Rothman et al. (2007) who evaluated the CardioNet system in 266 patients who had palpitations, presyncope, syncope or a combination of these symptoms. All patients had undergone 24 hours of monitoring with a Holter monitor, which failed to provide diagnostic information. These patients were randomized to 30 days of monitoring with MCOT (MCOT Group) or with an external loop monitor (Loop Group). Most of the patients in the Loop Group were required to activate the recorder when they experienced symptoms; however, 49 (18%) patients were at centers that had autotriggered recording of cardiac events. During monitoring, clinically significant arrhythmias were detected in 55 (41%) patients in the MCOT Group versus 19 (14%) patients in the Loop Group, a statistically significant difference. For patients who had syncope or presyncope, clinically significant arrhythmias were detected in 52% of patients with MCOT and in 15% of patients with loop recorders. In most cases, the arrhythmias detected were atrial fibrillation, atrial flutter, or ventricular tachycardia. A subgroup analysis was performed at the institutions that used autotriggered loop monitoring rather than patient-activated monitoring. A definitive diagnosis was obtained in this subgroup for 88% of MCOT Group patients versus 46% of Loop Group patients. However, this subgroup analysis involved a relatively small number of patients and the autotriggered devices may have had single ECG leads whereas the CardioNet system uses double ECG leads.

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Olson et al. (2007) reviewed the records of 122 consecutive patients evaluated using MCOT for palpitations, presyncope/syncope, or to monitor the efficacy of a specific antiarrhythmic therapy. Ten of 17 patients (59%) studied for presyncope/syncope had a diagnosis made with MCOT. Eight of these 17 patients had a previous negative evaluation for presyncope/syncope and five had an event correlated with the heart rhythm during the monitoring period. Nineteen patients monitored for palpitations or presyncope/syncope were asymptomatic during monitoring but had a prespecified arrhythmia detected. When MCOT was used as the first ambulatory monitoring system to evaluate palpitations (n = 18), 73% of patients correlated their symptoms with the underlying cardiac rhythm. Seven of 21 patients monitored for medication titration had dosage adjustments during outpatient monitoring. Joshi et al. (2005) evaluated MCOT retrospectively for 100 consecutive patients who were undergoing treatment for known arrhythmias or who were suspected to have arrhythmias based on symptoms such as palpitations, dizziness, or syncope. These patients underwent MCOT for 2 to 28 days with a mean monitoring time of 9.9 days. For this study, the effectiveness of MCOT was assessed based on detection of arrhythmias and changes in patient management after MCOT. Arrhythmias were detected in 51% of patients with 17% having supraventricular tachycardia and another 17% having atrial fibrillation or atrial flutter. Less common arrhythmias detected with MCOT were ventricular tachycardia, sinus node disease, long QT syndrome, second degree atrioventricular block, symptomatic sinus bradycardia, complete heart block, junctional rhythm, symptomatic premature ventricular complexes, and Wolff-Parkinson-White syndrome. Following MCOT, physicians prescribed the following changes in treatment on a per-patient basis: drug treatment started (14%), permanent pacemaker inserted (5%), cardiac tissue ablated (4%), drug treatment changed (3%), cardioverter defibrillator implanted (2%), anticoagulation stopped (2%), pacemaker replaced (1%), and drug treatment stopped (1%). Although these treatment changes were designed to address specific findings of cardiac monitoring, this study did not involve any subsequent monitoring or follow-up to determine whether patient outcomes were improved as a result of diagnostic information provided by MCOT. Saarel et al. (2008) conducted a smaller uncontrolled study of MCOT with the CardioNet system that differed from the other available studies in its enrollment of pediatric patients. A total of 54 patients were enrolled with a mean age of 12 years (range 3 to 20). The primary indication for cardiac monitoring was chest pain or palpitations with or without syncope for 42 (78%) patients and isolated chest pain, syncope, or presyncope for the other 12 (22%) patients. Patients were monitored for a mean of 25 7 days (range 9 to 32) and during this time 33 (61%) patients experienced symptoms that corresponded with arrhythmias. Of these 33 patients, 6 (18%) had supraventricular tachycardia or significant supraventricular or ventricular ectopy while the other 27 (82%) had benign conditions. Compared with a historical control group of 495 patients who underwent transtelephonic echocardiographic monitoring, MCOT had a higher diagnostic yield; however, this increase in diagnostic yield was not statistically significant. In a small uncontrolled study (n=19), Vasamreddy et al. (2006) used the CardioNet monitoring system to assess the efficacy of cardiac tissue ablation procedures for treatment of atrial fibrillation. This study found that, based on MCOT, 70% of patients were free of symptomatic atrial fibrillation and 50% of patients were free of asymptomatic atrial fibrillation. However, only 10 patients completed the study and patients underwent six 5-day periods of MCOT monitoring over 6 months rather than 30 days of

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monitoring before treatment, after treatment, and at 6 months follow-up. Tayal et al. (2008) reported on a case series of 56 patients with cryptogenic TIA/stroke who were analyzed after diagnostic evaluation and Mobile Cardiac Outpatient Telemetry (MCOT). Predictors of atrial fibrillation (AF) detection by MCOT were determined by univariate analysis including Student t test and Fisher exact tests and multivariate analysis. The median MCOT monitoring duration was 21 (range 5-21) days resulting in an AF detection rate of 23% (13/56). Twenty-seven asymptomatic AF episodes were detected in the 13 patients, of which 85% (23/27) were <30 seconds and the remaining 15% (4/27) were 4-24 hours in duration. The authors concluded that there is a high rate of atrial fibrillation (AF) detection by MCOT (21 days) in patients with cryptogenic TIA/stroke that may be related to extended monitoring duration, patient selection and inclusion of all new onset AF episodes. Brief AF episodes (<30 seconds) may be biomarkers of more prolonged and clinically significant AF. Outcomes of this study however resulted in minimal changes to patient management. In a guideline on the management of atrial fibrillation (AF), the National Institute for Health and Clinical Excellence (NICE) recommends the following in patients with suspected paroxysmal AF undetected by standard ECG recording: · a 24-hour ambulatory ECG monitor should be used in those with suspected asymptomatic episodes or symptomatic episodes less than 24 hours apart · an event recorder ECG should be used in those with symptomatic episodes more than 24 hours apart (NICE, 2006). Professional Societies American College of Cardiology (ACC)/American Heart Association (AHA)/European Society of Cardiology (ESC) A 2006 AHA/ACC scientific statement on the evaluation of syncope states that ambulatory ECG is appropriate in the absence of underlying heart disease when the diagnosis remains uncertain. A Holter monitor is appropriate for episodes that occur at least every day, and event monitoring is ideal for episodes that occur at least once a month. The introduction of continuously recording monitors that have both patient-activated and automatic triggers appears to improve the diagnostic yield of event monitors (Strickerger, 2006). ACC/AHA/ESC guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death state that continuous 24-48 hour Holter recordings are deemed appropriate when arrhythmias are known or suspected to occur at least once a day. Because intermittent event monitors can record over longer time periods, they are considered more appropriate when sporadic episodes produce symptoms of syncope, dizziness or palpitations. This guideline makes no mention of real-time continuous attended monitoring systems (Zipes, 2006). The 1999 ACC guidelines for ambulatory electrocardiography (AECG) are no longer available on the organization's website.

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U.S. FOOD AND DRUG ADMINISTRATION The CardioNet device has been classified as a combined ambulatory electrocardiograph and arrhythmia detector with alarm by the U.S. Food and Drug Administration (FDA). The CardioNet Ambulatory ECG Monitor with Arrhythmia Detection Model CN1001 (K012241) was approved for marketing by the FDA in February 2002. Additional information is available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/K012241.pdf. Accessed April 6, 2010. Several modifications have been made to the device in subsequent approvals (product code DSI). Additional information is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed April 6, 2010. The HEARTLinkTM II ECG Arrhythmia Detector and Alarm System, manufactured by Cardiac Telecom Corporation which uses [email protected] received FDA approval on November 13, 1998 (K982803). Additional information is available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/K982803.pdf. Accessed April 6, 2010. LifeStar ACT (LifeWatch®, Inc., a subsidiary of Card Guard Scientific) was approved by the FDA under the name CG-6108 Arrhythmia ECG Event Recorder (K060911) as a combined telephone electrocardiograph transmitter and receiver and arrhythmia detector and alarm (product codes DXH and DSI) on August 22, 2006. Additional information is available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K060911.pdf. Accessed April 6, 2010. Although there are no FDA approvals for the eCardio line of products, the company claims that the eVolutionTM device is an enhanced version of the ER900 Wireless Series Arrythmia Event Recorder (K072008). Additional information is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=25380. Accessed April 6, 2010.

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APPLICABLE CODES The codes listed in this policy are for reference purposes only. Listing of a service or device code in this policy does not imply that the service described by this code is a covered or non-covered health service. Coverage is determined by the benefit document. This list of codes may not be all inclusive. CPT® Code Description Wearable mobile cardiovascular telemetry with electrocardiographic recording, concurrent computerized real time data analysis and greater than 24 hours of accessible ECG data storage (retrievable with query) with ECG triggered and patient selected events transmitted to a remote attended surveillance center for up to 30 days; physician review and interpretation with report Wearable mobile cardiovascular telemetry with electrocardiographic recording, concurrent computerized real time data analysis and greater than 24 hours of accessible ECG data storage (retrievable with query) with ECG triggered and patient selected events transmitted to a remote attended surveillance center for up to 30 days; technical support for connection and patient instructions for use, attended surveillance, analysis and physician prescribed transmission of daily and emergent data reports

CPT® is a registered trademark of the American Medical Association.

93228

93229

Coding Clarification CPT codes 93235, 93236 and 93237 are used to code for wearable cardiac monitoring devices that do not transmit to an attended surveillance center. Devices used for these three codes have a computer chip that monitors heart rhythms continuously and flags an abnormal rhythm. They can also be patient activated. Data is stored and read later. These codes are not for use when information is transmitted in real or near-real time to a remote attended surveillance center (AMA, 2009b). UnitedHealthcare considers devices represented by these codes to be advanced Holter monitors. Use of these devices for more than 48 hours is beyond the code description. For devices that do not perform automatic ECG triggered transmissions to an attended surveillance center, see CPT codes 93224-93227 and 93230-93272. Devices that provide automatic ECG-triggered transmission and are worn for greater than 48 hours should not be reported with codes 93224-93227 and 93230-93272 (AMA CPT Assistant, 2009b).

REFERENCES Agency for Healthcare Research and Quality (AHRQ). Technology Assessment. Remote cardiac monitoring. December 2007. Available at: http://www.cms.hhs.gov/mcd/viewtechassess.asp?where=index&tid=51. Accessed April 6, 2010.

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American Medical Association (AMA). CPT Changes 2009a: An Insider's View. p. 162. American Medical Association (AMA). CPT Assistant. March 2009b; 19(3):5-7. CardioNet Inc. [Website]. Available at: http://www.cardionet.com. Accessed April 6, 2010. Centers for Medicare & Medicaid Services (CMS). NCD 20.15, Electrocardiographic Services. Effective August 26, 2004. Accessed June 2010. Centers for Medicare & Medicaid Services (CMS) Palmetto GBA (01301) LCD for Cardiac Event Detection (L27563). Effective: August 20, 2008, Updated: April 07, 2010. Accessed June 2010. Centers for Medicare & Medicaid Services (CMS) Palmetto GBA (01301) LCD for Dynamic Electrocardiography (EKG, ECG) (L27569) Effective: August 20, 2008.Updated: April 07, 2010. Accessed June 2010. eCardio Diagnostics [Website]. Available at: http://www1.ecardio.com/. Accessed April 6, 2010. ECRI Institute. Custom Hotline Response. Mobile cardiac outpatient telemetry for detecting arrhythmias. April 2009. Fuster V, Ryden LE, Cannom DS, Crijns HJ, et.al. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation. J Am Coll Cardiol. 2006 Aug 15;48(4):854-906. Available at: http://content.onlinejacc.org/cgi/reprint/48/4/e149.pdf. Accessed April 6, 2010. Hayes, Inc. Search and Summary. eCardio Services for Monitoring Arrhythmias. Lansdale, PA: Hayes, Inc. September 2009. Hayes, Inc. Health Technology Brief. Mobile Cardiac Outpatient Telemetry (MCOT) for Home Monitoring of Cardiac Patients. Lansdale, PA: Hayes, Inc. April 2008. Updated March 2009. 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. LifeWatch [Website]. Available at: http://www.lifewatch.com/. Accessed April 6, 2010. National Institute for Health and Clinical Excellence (NICE). Clinical guideline 36. Atrial Fibrillation. June 2006. Available at: http://www.nice.org.uk/nicemedia/pdf/CG036niceguideline.pdf. Accessed April 6, 2010. Olson JA, Fouts AM, Padanilam BJ, Prystowsky EN. Utility of mobile cardiac outpatient telemetry for the diagnosis of palpitations, presyncope, syncope, and the assessment of therapy efficacy. J Cardiovasc Electrophysiol. 2007 May;18(5):473-7. Epub 2007 Mar 6.

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Rothman SA, Laughlin JC, Seltzer J, et al. The diagnosis of cardiac arrhythmias: A prospective multicenter randomized study comparing mobile cardiac outpatient telemetry versus standard loop event monitoring. J Cardiovasc Electrophysiol. 2007;18(3):241-247. 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. Strickberger SA, Benson DW, Biaggioni I, et al. AHA/ACCF scientific statement on the evaluation of syncope. J Am Coll Cardiol. 2006 Jan 17;47(2):473-84. Available at: http://content.onlinejacc.org/cgi/reprint/47/2/473.pdf. Accessed April 6, 2010. Tayal AH, Tian M, Kelly KM, Jones SC et al. Atrial fibrillation detected by mobile cardiac outpatient telemetry in cryptogenic TIA or stroke. Neurology. 2008 Nov 18;71(21):1696-701. Vasamreddy CR, Dalal D, Dong J, et al. Symptomatic and asymptomatic atrial fibrillation in patients undergoing radiofrequency catheter ablation. J Cardiovasc Electrophysiol. 2006;17:134-139. Zipes DP, Camm AJ, Borggrefe M, Buxton A et al. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. J Am Coll Cardiol. 2006 Sep 5;48(5):e247-346. Available at: http://content.onlinejacc.org/cgi/reprint/48/5/e247.pdf. Accessed April 6, 2010.

PROTOCOL HISTORY/REVISION INFORMATION Date 01/01/2010 07/01/2010 06/24/2010 06/26/2009 Action/Description Medical Technology Assessment Committee Corporate Medical Affairs Committee

Outpatient Cardiovascular Telemetry

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