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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 11/01/2011 Title: Cardiac Event Recorder, External Loop Recorder
Revision Date: 06/01/2019 Document: BI317:00
CPT Code(s): 93268, 93270-93272, 0295T, 0296T, 0297T, 0298T
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

There are several devices to monitor cardiac rhythm of the ambulatory patient.  Rhythm can be monitored continuously or intermittently by external or implanted devices.  The simplest is the patient-activated event recorder that the patient carries in their pocket or purse.  The patient activates this device at the time of symptoms by placing the recorder against the chest and pressing a button.  This device does not review an asymptomatic event or rhythm before patient activation.

These devices are covered for patients who have symptoms that may indicate cardiac rhythm disturbance.


Medical Statement

A pre-symptom memory loop cardiac event recorder meets primary coverage criteria for effectiveness and is covered based on a 30-day period of observation for patients whose symptoms are considered infrequent enough that it would be unlikely that a cardiac arrhythmic event would be captured by a rhythm strip or 24-hour continuous EKG waveform recording and storage or computerized monitoring device.  To properly bill for CPT 93268 or any of the components (CPT 93270, 93271, or 93272), a monitoring service must be available 24-hours per day, 7 days a week, to allow the patient to report any activation of the monitor.  Twenty-four hour coverage means that there must be, at the monitoring site (or sites) an experienced EKG technician receiving calls; tape recording devices do not meet this requirement.  Further, such technicians should have immediate access to a physician, and have been instructed in when and how to contact available facilities to assist the patient in cases of emergencies. Ambulatory cardiac monitoring for more than 48 hours up to 21 days by continuous rhythm recording and storage (Zio patch system) is covered without prior authorization.

 

This form of EKG monitoring is ordered only by the patient`s physician as part of an overall plan of treatment.  This monitoring is used to record symptomatic episodes of rate disturbance.

 

The patient`s physician must order the monitoring service.  The patient must have seen that physician within one month of initiating of monitoring.  The patient must be symptomatic.

 

Codes Used In This BI:

 

93268

External patient and, when performed, auto activated ECG rhythm derived event recording...up to 30 days, 24-hour attended monitoring; includes transmission, physician review and interpretation

93270

External patient and, when performed, auto activated ECG rhythm derived event recording...up to 30 days, 24-hour attended monitoring; recording

93271

External patient and, when performed, auto activated ECG rhythm derived event recording...up to 30 days, 24-hour attended monitoring; transmission download and analysis

93272

External patient and, when performed, auto activated ECG rhythm derived event recording...up to 30 days, 24-hour attended monitoring; physician 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. 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


Limits

This device is not covered when used in clinics, nursing homes, hospitals, ambulatory surgery centers, or other facilities for the routine transmission of electrocardiograms or rhythm strips or monitoring of patients.


Background

Cardiac event recording is a well-established technique for evaluating symptoms compatible with arryhthmia when symptoms occur too infrequently to be captured on 24-hour Holter monitoring.  

 

AEMs are a well-established technology that are most typically used to evaluate episodes of cardiac symptoms (palpitations, dizziness, syncope), which, due to their infrequency, would escape detection on a standard 24- to 48-hour Holter monitor. Other proposed uses include monitoring the efficacy of antiarrhythmic therapy and evaluating ST segment changes as an indication of myocardial ischemia. However evidence is inadequate to validate these uses of AEMs. Although serial EKG monitoring has often been used to guide antiarrhythmic therapy in patients with symptomatic sustained ventricular arrhythmias or survivors of near sudden cardiac death (DiMarco, 1990), it is not known what level of reduction of arrhythmic events constitute successful drug therapy. Furthermore, the patient’s cardiac activity must be evaluated before and during treatment, such that the patient can serve as his or her own control. The routine monitoring of asymptomatic patients after myocardial infarction is additionally controversial, especially after the Cardiac Arrhythmia Suppression Trial (CAST) showed that patients treated with encainide or flecainide actually had a higher mortality. While Holter monitoring has been used to detect ST segment changes, it is unclear whether ST segment changes can be reliably detected by an AEM. The interpretation of ST segment change is limited by instability of the isoelectric line, which is in turn dependent on meticulous attention to skin preparation, electrode attachment, and measures to reduce cable movement.

 

In 1999, the American College of Cardiology (ACC) in conjunction with the American Heart Association (AHA) published guidelines for the use of ambulatory electrocardiography.  These guidelines did not make an explicit distinction between continuous (i.e., Holter monitor) and intermittent (i.e., ambulatory event monitor) monitoring. Regarding the effectiveness of antiarrhythmic therapy, the ACC guidelines list one Class I* indication: “To assess antiarrhythmic drug response in individuals in whom baseline frequency of arrhythmia has been well characterized as reproducible and of sufficient frequency to permit analysis.” The guidelines do not specify whether Holter monitoring or ambulatory event monitors are most likely to be used. However, the accompanying text notes that intermittent monitoring may be used to confirm the presence of an arrhythmia during symptoms. This indication is addressed in the first policy statement above, i.e., evaluation of symptomatic patients. There were no Class I indications for detection of myocardial ischemia. In addition, there were no Class I indications for ambulatory monitoring to assess risk for future cardiac events in patients without symptoms of arrhythmia. This latter category would suggest that routine monitoring of patients after myocardial infarction to detect nonsustained ventricular tachycardia as a risk factor for sudden cardiac death is not routinely recommended. As noted in a review article by Zimetbaum and Josephson, 1999, there is a paucity of data to document the impact on the final health outcomes, and, furthermore, it is not clear at what point after a myocardial infarction such monitoring would be optimal.

 

Several studies, including an analysis of a database of 100,000 patients, compared the diagnostic yield of automatic and patient-activated arrhythmia recordings, and reported an improved yield with auto-triggering devices. (Ermis C, 2003; Reiffel JA, 2005; Balmelli N, 2003)  One comparative study of 50 patients noted that auto-activation may result in a large number of inappropriately stored events.  (Ng E , 2004)  The policy statement does not distinguish whether the device used is auto- or patient-activated.

 

Rothman and colleagues recently reported results comparing MCOT to standard loop recording. (10 Rothman SA, 2007) This study involved 305 patients who were randomized to the LOOP recorder or MCOT and who were monitored for up to 30 days. The unblinded study enrolled patients at 17 centers for whom the investigators had a strong suspicion of an arrhythmic cause of symptoms including those with symptoms of syncope, presyncope, or severe palpitations occurring less frequently than once per 24 hours and a nondiagnostic 24-hour Holter or telemetry monitor within the prior 45 days. Test results were read in a blinded fashion by an electrophysiologist. Study exclusions were Class IV heart failure, myocardial infarction within the prior 3 months, unstable angina, history of sustained ventricular tachycardia or ventricular fibrillation, and complex ectopy with an ejection fraction less than 35%.

 

While 305 patients were randomized, results from 266 were analyzed using patients who completed at least 25 days of monitoring, 132 in the LOOP group and 134 in the MCOT group. Of the 39 patients who did not complete the protocol, 20 (13 MCOT and 7 LOOP) did not complete the study due to non-compliance (non-wearing) with the device. Patients were predominantly female with a mean age of 56 years. Approximately 20% had a history of heart disease, 50% hypertension, and 5% heart failure.

 

A diagnostic endpoint (confirmation/exclusion of arrhythmic cause of symptoms) was found in 88% of MCOT patients and 75% of LOOP patients (p = 0.008). The difference in rates was due primarily to detection of asymptomatic (not associated with simultaneous symptoms) arrhythmias in the MCOT group consisting of rapid atrial fibrillation and/or flutter (15 patients vs. 1 patient) and ventricular tachycardia defined as more than 3 beats and rate greater than 100 (14 patients vs. 2 patients). These were thought to be clinically significant rhythm disturbances and the likely causes of the patients’ symptoms. The paper does not comment on the clinical impact (changes in management) of these findings in patients for whom the rhythm disturbance did not occur simultaneously with symptoms. In this study, the median time to diagnosis in the total study population was 7 days in the MCOT group and 9 days in the LOOP group. Of note, prior studies of the auto trigger loop recorder have also shown similar findings that are viewed as improvements over traditional LOOP recordings that require patient activation.

 

A subset of only 50 patients (related to device availability) received the newer auto trigger loop recorders. This study protocol does not allow for adequate comparisons between the auto trigger and the MCOT device.

 

The auto trigger loop recorders have become a part of the standard diagnostic approach to patients who have infrequent symptoms that are thought likely to be due to arrhythmias. Therefore, this is the test to which newer technologies must be compared. Currently, the literature does not provide any adequate comparative data for the auto trigger device compared to mobile cardiac telemetry. Further study of MCOT is needed to replicate the Rothman study and to compare MCOT with the auto trigger loop recorder.


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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