Cardiac arrhythmias are abnormal heart rhythms that can cause palpitations, weakness, dizziness, fainting, blood clots, or death. There are a wide variety of treatments available for arrhythmias, however, obtaining an accurate diagnosis can be difficult since arrhythmias can occur infrequently and unpredictably and may not cause obvious symptoms. Remote cardiac monitoring technologies allow home electrocardiographic (EKG) monitoring of individuals with suspected cardiac arrhythmias or at risk for developing arrhythmias.

A variety of ambulatory external EKG monitoring systems have been developed. These include 24–48-hour Holter monitoring, 7–14-day patch-type monitoring, self-activated event monitors, and auto-triggered loop monitors. To detect infrequent arrhythmias, members can undergo 24 to 48 hours of continuous outpatient EKG recording with a Holter monitor. A limitation of this device is that repeated monitoring sessions may be necessary if an arrhythmia does not occur during the first 1 or 2 days.

Another method for detection of infrequent arrhythmias is the use of an event recorder, which stores 1 to 2 minutes of EKG data as soon as the individual experiences symptoms and presses a button to activate the device. Although this technique enables a much longer period of monitoring, some arrhythmias do not cause obvious symptoms and some symptomatic members fail to turn on the recorder at the right time.

The following are descriptions of various cardiac event monitors:

• Cardiac event detection monitoring (implantable loop monitoring): An implantable loop recorder (ILR) is rarely the preferred initial test for ambulatory ECG monitoring (AECG). However, this test can be useful for members with infrequent (e.g. less than monthly) symptoms that are potentially harmful to the individual. An ILR is implanted subcutaneously in a member’s upper left chest and left for several months.
• Continuous AECG monitoring (24- or 48-hour Holter monitoring): The Holter monitor reports total heart beats as well as average and maximum/minimum heart rates. It provides representative hourly samples of the ECG tracing and episodes of tachyarrhythmia and the etiology of the arrhythmias as well as pauses. The monitor detects a number of premature beats (supraventricular and ventricular), ST segment changes, member-reported symptoms associated ECG findings and the longest R-R interval with pauses greater than three seconds. The Holter monitor may be the preferred ambulatory ECG monitoring test for members with daily or near daily symptoms and for those who would prefer a comprehensive assessment of all cardiac activity over the given 24–48-hour interval.
• Continuous AECG monitoring for periods greater than every 48 hours (e.g., Zio® Patch): The Zio® Patch is a single-use AECG monitor that has the capability of collecting data for up to 14 days for those with suspected cardiac arrhythmias (e.g., ventricular tachycardia (VT), supraventricular tachycardia (SVT), paroxysmal atrial fibrillation (AF), atrioventricular block, symptomatic bradycardia and greater than 3-second pauses).
• External cardiac event detection monitoring (e.g., external loop monitoring): An external loop monitor has the capability to monitor an individual for long durations (e.g., up to seven days) and thus has a higher chance of providing a diagnosis to those whose symptoms occur infrequently.

It is recommended for those with infrequent short-duration transient symptoms, reoccurring over weeks or months.

Clinical Guideline Coverage Criteria

The Plan considers the following cardiac event monitors medically necessary when age specific and device specific criteria are met:

General Criteria:

• Continuous ambulatory electrocardiography (AECG) monitoring (24- or 48-hour Holter monitoring) is considered medically necessary when:
  • Documentation confirms infrequent arrhythmia is unlikely to be diagnosed by a standard 12-lead ECG AND results of this testing will provide diagnostic or treatment information necessary for the management of the member beyond what would be provided by the 12-lead ECG
• External cardiac event detection monitoring (e.g., external loop monitoring) is considered medically necessary when:
  • Documentation confirms infrequent arrhythmia is unlikely to be diagnosed by a 24- or 48-hour Holter monitor AND results of this testing will provide diagnostic or treatment information necessary for the management of the member beyond what would be provided by the continuous 24- or 48-hour Holter monitor
• Cardiac event detection monitoring (e.g., implantable loop monitoring), is considered medically necessary when:
  • Documentation confirms infrequent arrhythmia is unlikely to be diagnosed by a 24- or 48-hour Holter monitor and/or external loop monitor AND results of this testing will provide diagnostic or treatment information necessary for the management of the member beyond what would be provided by the continuous 24- or 48-hour Holter monitor and/or external loop monitor
• Continuous ambulatory electrocardiography (AECG) monitoring for periods greater than 48-hours (e.g., Zio® Patch) considered medically necessary when:
  • Documentation confirms trial of other appropriate testing/monitoring (i.e., 24- or 48-hour Holter monitor and/or 48-hour telemetry) that did not provide necessary diagnostic information; AND Individual with a non-diagnostic Holter monitor or 48-hour experiences syncope, lightheadedness, or infrequent symptoms unlikely to be diagnosed by Holter monitoring

Age-Specific Criteria:

The provider must also have all prior testing and result documentation and one or more of the following age-specific criteria must be met for monitoring devices to be considered medically necessary:

Adults:

• Evaluation of infrequent recurrent symptoms (e.g. presyncope, syncope lightheadedness, palpitations, shortness of breath, chest pains or dizziness) that may be associated with arrhythmia, OR
• Evaluation of members with unexplained recurrent palpitation after complete examination, OR
• Assessment of individuals with documented coronary artery disease (CAD) for silent myocardial ischemia, OR
• Monitoring members who have had surgical or catheter ablation of atrial fibrillation when discontinuation of systemic anticoagulation is being considered, OR
• Assessment of individuals who have had a history of cryptogenic stroke along with evidence of prior non-diagnostic tests, OR
• Evaluation of members with idiopathic hypertrophic or dilated cardiomyopathies to detect arrhythmias.

Pediatric:

• Antiarrhythmic drug efficacy, during rapid somatic growth, OR
• Asymptomatic congenital atrioventricular block, non-paced, OR
• Documented or potential long QT syndromes (LQTS), OR
• Hypertrophic or dilated cardiac myopathies, OR
• Palpitations in members with previous surgery for congenital heart disease and significant residual hemodynamic abnormalities, OR
• Previously documented arrhythmia or pacemaker dependency, OR
• Syncope, near syncope associated with exertion or dizziness with known heart disease.

Note: Repeat studies within a 1-year time frame may be subject to review based on medical necessity.

Limitations

Harvard Pilgrim Health Care (HPHC) considers cardiac event monitors experimental/investigational for all other indications.

In addition, HPHC does not cover:

• Ambulatory electrocardiography (AECG) monitoring managed through mobile devices (e.g., Kardia Mobile, BodyGuardian Remote Monitoring System, iHEART, ViSi Mobile Monitoring System)
• BioTel MCT 3 Lead (MCT 3L)
• Biotronik BioMonitor
• CardioMEMS™
• CardioPatch
• EndoSureTM Wireless Implantable System

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