History/Background and/or General Information
Long-term wearable electrocardiographic monitoring (WEM) is a diagnostic procedure that provides a record of the heart rhythm during daily activities. This procedure can often identify the existence and determine the frequency of clinically significant rhythm disturbances and waveform abnormalities that are missed on a standard electrocardiogram (ECG).
WEM are generally classified by the following:
1. Non-Activated Continuous Recorders (holter monitor/external electrocardiographic recording) provide a continuous record of heart rhythm over a set period of time (usually twenty four hours and up to a 48 hour period). This procedure can often identify the existence of ECG rhythm derived elements that are missed on a standard ECG. This service is appropriate when arrhythmias are known or suspected to occur at least once in 48 hours.
Electrocardiographic monitoring can be performed on ambulatory patients over a set period of time (usually twenty four hours). The monitoring device (holter monitor) allows the patient to resume their normal lifestyle and activities while recording episodes of arrhythmia. This gives the physician documented episodes of arrhythmias or absence of arrhythmias to correlate with the patient's symptoms.
This local coverage determination policy is being developed to clearly define the circumstances for which twenty-four hour continuous electrocardiographic monitoring is considered to be medically reasonable and necessary, and therefore covered.
Covered Indications for Non-Activated Continuous Recorders
Twenty-four hour electrocardiographic monitoring is medically necessary in any of the following circumstances:
- The patient complains of palpitations, and physical examination and standard EKG have not satisfactorily explained the patient's complaints.
- The patient has experienced an unexplained syncopal episode or the patient has experienced a transient episode of cerebral ischemia which is felt to possibly be secondary to a cardiac rhythm disturbance.
The patient has been found to have a significant cardiac arrhythmia or conduction disorder (see list below) and holter monitoring is necessary as part of the evaluation and management of the patient:
- Complete Heart Block
- Second Degree AV Block
- New Left Bundle Branch Block
- New Right Bundle Branch Block
- Bifasicicular Block
- Paroxysmal SVT
- Paroxysmal VT
- Atrial Fib/Flutter
- Ventricular Fib/Flutter
- Cardiac Arrest
- SA Node Dysfunction
- Frequent PAC's
- Frequent PVC's
- Wandering Atrial Pacemaker
- Unspecified Cardiac Arrhythmia
The patient has a heart condition (see list below) associated with a high incidence of serious cardiac arrhythmia and/or myocardial ischemia, and holter monitoring is being done as part of the evaluation and management of the patient
- Dressler's Syndrome
- History of Myocardial Infarction
- Angina Pectoris
- Prinzmetals's Angina
- Aneurysm of Heart Wall
- Chronic Ischemic Heart Disease
- Pericarditis
- Mitral Valve Disease
- Cardiomyopathy
- Anomalous AV Excitation
- Cardiomegaly
- Post Heart Surgery
- Prolonged QT Interval
The patient has a cardiac arrhythmia or other cardiac condition and a cardiac medication which affects the electrical conduction system of the heart has been prescribed, and holter monitoring is necessary to evaluate the effect of the cardiac medication on the patient's cardiac rhythm and/or conduction system.
The patient has a pacemaker and clinical findings (history or physical examination) suggest possible pacemaker malfunction.
Claims submitted for holter studies performed at unusually frequent intervals will be reviewed to make certain that the services were medically reasonable and necessary.
2. Patient/Event-Activated Intermittent Recorders (loop event monitors, remote cardiovascular monitoring) are indicated when symptoms are sporadic to establish whether or not they are caused by transient arrhythmias.
This service is an appropriate alternative to 48 hour monitoring in patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of cardiac arrhythmias (i.e., palpitations, dizziness, presyncope or syncope) or when a 48 hour service is not diagnostic.
Ambulatory electrocardiography (AECG) refers to services rendered in an outpatient setting over a specified period of time, generally while a patient is engaged in daily activities, including sleep. AECG devices are intended to provide the physician with documented episodes of arrhythmia, which may not be detected using a standard 12-lead EKG. AECG is most typically used to evaluate symptoms that may correlate with intermittent cardiac arrhythmias and/or myocardial ischemia. Such symptoms include syncope, dizziness, chest pain, palpitations, or shortness of breath. Additionally, AECG is used to evaluate patient response to initiation, revision, or discontinuation of arrhythmic drug therapy.
An event recorder is a portable unit, attached to a patient, which permits the patient to record an EKG rhythm strip at the onset of symptoms (e.g., syncope, dizziness) or in response to a physician’s order (e.g., immediately following strong physical exertion). Most devices also permit the patient to simultaneously voice-record in order to describe the symptoms and/or activity concurrently. There are two basic types of event recorders (post-event and pre-event), which are differentiated on the basis of memory.
When the goal is to correlate the patient’s rhythm or EKG pattern with symptoms that are very infrequent (at weekly intervals or more), the patient activated event recorder is the optimal choice. However, if the patient’s symptoms are of such brief duration (seconds) or severity (frank syncope) to preclude capture by such a unit, then a loop event recorder is required. It is important to correlate an abnormal rate and rhythm with cardiovascular symptomatology and determine the precise mechanism of the arrhythmia.
Covered Indications for Patient/Event-Activated Intermittent Recorders
The use of patient demand single or multiple event recorders will be considered medically reasonable and necessary under the following circumstances:
When indicated for the 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.
A definitive diagnosis has not been made after all of the following conditions have been met:
- The patient has undergone a complete history and physical by a physician prior to the initiation of monitoring. The history and physical must indicate that the patient is experiencing recurrent, transient symptoms suggestive of cardiac arrhythmia Note: Palpitations are extremely common in healthy individuals. Therefore, if palpitations is billed as the diagnosis supporting medical necessity, the history and physical or other pertinent medical record documentation must support the presence of associated symptoms such as dizziness, shortness of breath, chest discomfort, or an underlying history of cardiac disease; and
The patient has undergone a 12 lead EKG and rhythm strip.
- A physician overseeing the medical management of the patient orders the medically necessary patient demand event recorder.
- Any device used for event recording must be FDA approved for the indication for which it is being utilized.
- The FDA approved device must be capable of transmitting EKG leads I, II, or III (the standard limb leads). To generate a sufficient EKG rhythm strip, the device must either have “built in” electrodes, such that placement of the device on the patient’s precordium produces an EKG reading of lead I, II, or III, or the device involves the proper placement/attachment of at least two electrodes to the patient. Because it is not practical to attach electrodes to the arms and legs, modifications of the standard limb leads must be utilized. Electrode placement for the monitor limb leads is similar to standard placement, except that the left and right shoulder or subclavian areas and the lower left quadrant of the abdomen are used for electrode placement. The following are the sites for proper lead placement to generate a lead I, II, or III:
LEAD / + ELECTRODE / - ELECTRODE:
- I / Lt. subclavian (shoulder) / Rt. subclavian (shoulder)
- II / Lt. lower quadrant abdomen / Rt. subclavian (shoulder)
- III / Lt. lower quadrant abdomen / Lt. subclavian (shoulder)
The transmission of the EKG lead I, II, or III must be sufficiently comparable to readings obtained by conventional EKG to permit proper interpretation of abnormal cardiac rhythms. EKG tracings normally consist of three identifiable waveforms: the P wave (depicting atrial depolarization), the QRS complex (depicting ventricular depolarization), and the T wave (depicting ventricular repolarization). The lead II rhythm strip depicts the heart’s rhythm more clearly than any other waveform.
A provider of the service must be capable of receiving and recording transmissions 24-hours per day, every day of the year. This is applicable to those CPT codes whose descriptor indicates “24-hour attended monitoring” This includes receipt of the EKG signal, as well as the voice transmission relating any associated symptoms.
The designated monitoring facility must have on-site 24-hour availability of an attendant trained in equipment operation and on-line analysis of the transmitted EKG tracing when CPT codes requiring 24-hour attended monitoring are ordered.
The transmissions must be received by a person capable of responding to the transmission. The transmission is not to be received by an answering machine for review at a later time when CPT codes requiring 24-hour attended monitoring are ordered.
The person receiving the transmission must be a technician, nurse, or physician trained in interpreting EKGs and abnormal rhythms. A physician must be available for immediate consultation to review the transmission, in case of significant symptoms or EKG abnormalities, when CPT codes requiring 24-hour attended monitoring are ordered.
A provider of the service must be capable of immediately notifying the patient’s attending physician when indicated. The referring physician’s telephone number and other emergency instructions for the patient should be included in the referral for the monitoring services. The recording device and transmission equipment must be verifiably in the patient’s possession for the entire thirty day period of submission.
The patient must be instructed in and capable of facile operation of both the recording device and the transmission device. Therefore, the patient must not be limited by a medical condition that would indicate that the patient is incapable of the proper operation of the device (e.g., a patient with senile dementia, Organic Brain Syndrome (OBS), Alzheimers, mental retardation, etc.). If a responsible party is required to assist the patient in the device operation and transmissions, that party must be present on a 24-hour basis. The instructions regarding the operation of the device, changing the batteries, etc. must be given by the provider of the monitoring service to the patient/responsible party prior to initiation of use of the patient demand event recorder.
Limitations
- No more than one 48 hour WEM service would be expected in a 6 month period.
- No more than one 30 day WEM service would be expected in a 6 month period.
- Use of WEM more frequently than at 6 month intervals requires physician documentation in the progress notes specifically supporting the medical necessity of a more frequent interval.
As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.
