LCD L40244: Temporary Nontherapeutic Ambulatory Cardiac Monitoring Devices

Background

Ambulatory electrocardiography provides a record of a patient’s heart rhythm and rate during a specific time frame. The recording could lead to the diagnosis of underlying and undetectable abnormalities. Monitoring allows for the detection of irregular heart rhythms or arrhythmias. These rate disturbances including waveform abnormalities can be missed on a standard electrocardiogram (ECG). The prevalence of cardiac arrythmias in the general population is 1.5% to 5%. 1 However, with advancing age and increased incidence of structural heart disease, the frequency, complexity and the prognostic significance of the arrythmias worsens. 2 Cardiac arrhythmias are the presenting event in approximately 50% of deaths from cardiovascular disease. 1

Temporary nontherapeutic ambulatory cardiac monitoring devices (TNACMD) provide invaluable data regarding arrhythmias, palpitations, syncope and other cardiac monitoring needs. The devices include Holter monitors, event recorders/monitors, patch recorders, external loop recorders (ELR), mobile cardiovascular telemetry (MCT) and mobile cardiovascular outpatient telemetry (MCOT). These distinct devices have different capabilities, varying from intermittent to continuous recordings, and are either patient activated, or rhythm activated recordings. They range in terms of number of leads, time frame length, whether the recordings are being monitored in real time, or if the information recorded needs to be transferred from the device for further interpretation. These devices are not to be utilized in patients at risk for immediate, life-threatening arrythmias (Class I) which require inpatient care. 3

The purpose of the LCD is to provide the scope of indications that are supported as reasonable and necessary for the usage of temporary ambulatory nontherapeutic monitoring devices in the appropriate patients.

Coverage

All utilization of electrocardiographic services must align with requirements in NCD 20.15.

Cardiac monitoring is reasonable and necessary when the following criteria are met:

• Temporary (not implanted), AND

• Presence of symptoms suggestive of cardiac arrythmia with symptoms (such as palpitations, dizziness, presyncope, syncope, chest pain or shortness of breath) occurring infrequently (>24 hours between symptomatic episodes), 38-40,46,48,54 OR

• Monitoring is necessary to regulate medication management such as antiarrhythmic drug dosage, 28,48 OR

• Patients with non-lacunar cryptogenic stroke or stroke or transient ischemic attack (TIA) of undetermined origin to monitor undiagnosed atrial fibrillation (AF) or anticoagulation management, 35-37,43,44,50,51,53 OR

• To monitor patients who have had surgical or ablative procedures for arrhythmia, 32,47 OR

• To assess for asymptomatic ventricular premature beats or non-sustained ventricular tachycardia in patients with hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, long QT syndrome, dilated or restrictive cardiomyopathy, congenital heart disease, or Brugada syndrome, 42,45,48 OR

• Embolic-appearing pattern of myocardial infarction, 41 OR

• Evidence of systemic emboli, OR

• Monitoring for arrhythmic events pre/post-TAVR 20-25,55

Device Requirements:

• FDA cleared, AND

• Align with CPT coding standards, FDA clearance, and instructions for their device type including attended surveillance where applicable.

Limitations:

• TNACMD 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 ECG has already established a diagnosis), or if other tests are better suited to obtain clinical data relevant to the patient's condition. The TNACMD should be coordinated with results from standard ECGs, Holter monitor tests, and stress tests.

• The purpose of TNACMD is the long-term monitoring of patients to document suspected or paroxysmal dysrhythmia. Therefore, it is considered medically unnecessary to utilize a TNACMD service when only a standard ECG is required (even if it is used to transmit that ECG to another location).

• The receiving station (for mobile cardiac telemetry) must be staffed on a 24-hour basis with a minimum of an EKG technician or other non-physician staff. 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 be instructed as to when and how to contact available facilities to assist the patient in case of emergencies. An answering service/answering machine would not fulfill this requirement. 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.

• A test not ordered by a physician or qualified non physician practitioner treating the beneficiary will be denied as not medically necessary.

• It is expected that TNACMD will not be used for the routine daily transmission of ECG rhythm strips, or monitoring, in the absence of identified symptoms necessitating diagnosis as stated in this LCD.

• TNACMD is covered only as diagnostic tests or for evaluating a patient being actively managed on arrhythmic medication.

• TNACMD is not covered for patients in hospitals, emergency rooms, skilled nursing facilities or other specialized facilities, including outpatient or facility-based cardiac monitoring.

• 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 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.

• 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.

• "Routine" continued monitoring in the absence of treatable symptoms is considered screening and is not medically necessary.

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 TNACMD will be denied as not medically necessary when patients do not have exclusive use of a recorder for the entire service period (30 days). Cardiac event detection is a packaged service, with device monitoring durations that may be less than or up to 30 days depending on the device used. Tests cannot be billed during any period that overlaps with the billing timeframe of another device covered in this policy, even if the previous test was discontinued due to documented arrhythmias and the patient is reconnected for follow-up therapy or intervention.

Definitions

Temporary Nontherapeutic Ambulatory Cardiac Devices (TNACMD): A portable device which can be attached to the skin to temporarily record the electrical activity of the heart. This allows healthcare providers to monitor the patient over a period of up to 30 days.

Atrial Fibrillation (AF): Supraventricular tachyarrhythmia with uncoordinated atrial electrical activation and ineffectual atrial contraction.

Clinical AF: Symptomatic or asymptomatic AF documented on surface electrocardiogram (ECG).

Subclinical AF or Atrial high-rate episode (AHRE): Asymptomatic AF without previous clinical diagnosis of AF.

Cryptogenic Stroke: Subtype of Ischemic stroke without a determined cause or more than one competing cause (30-40% of all ischemic strokes).

Embolic Stroke of Undetermined Source (ESUS): Non-lacunar cryptogenic stroke subtype without identifiable cause despite extensive investigation, including more than 24 hours of cardiac monitoring.

Heart Block: The partial or complete interruption of electrical impulses from the atria to the ventricles (Atrioventricular (AV) block), where the rate is slower, or the rhythm is abnormal.

Implantable cardioverter defibrillator (ICD): A device implanted in the chest to detect and treat life-threatening cardiac arrhythmias by delivering electrical shocks or pacing.

Intraventricular conduction delay (IVCD): Prolongation of the QRS exceeding the typical upper limit of normal but does not meet criteria for a specific conduction block.

Junctional Rhythm: Abnormal rhythm originating from the AV node or the Bundle of HIS (HB).

Non-lacunar Stroke: Cerebrovascular accident presumed to be caused by a thromboembolic event from the heart or the large extracranial arteries.

Acute Coronary syndrome (ACS): Acute myocardial infarction or ischemia.

Silent Myocardial Ischemia: Asymptomatic cardiac ischemia on testing without angina or an anginal equivalent.

Systemic emboli: Embolic events affecting organs or tissues outside the heart, confirmed by clinical, imaging, or laboratory findings.

Literature Analysis

This summary of the evidence has been formatted by the type of comparator, outcome category, (e.g., diagnostic yield, undesirable effects), and study design. The literature analysis emphasizes the research designs representative of the body of evidence (systematic reviews, meta-analyses) and the primary studies most applicable to specific outcomes e.g., randomized controlled trials (RCTs) for diagnostic yield. Multiple publications from the same dataset were grouped together in the analysis regardless of study design. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach domains of study limitations (risk of bias), indirectness (applicability), imprecision, inconsistency, and publication bias formed the basis of appraisal of the certainty of evidence [see Attachments, Tables 1 and 2].

Description of Studies

This description of studies is supplemented by tables 3–8 (see Attachments) that further summarize the characteristics, findings, and assessments of included studies.