LCD L39492: Ambulatory Electrocardiograph (AECG) Monitoring

Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

Ambulatory Electrocardiograph (AECG) diagnostic procedures provide a record of the heart rhythm during daily activities. AECG 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).

AECG continues to advance at a rapid pace and incorporates various monitoring devices and indications for use. These devices range from Holter Monitors, Event Recorders/Monitors, Patch Recorders, External Loop Recorders, Mobile Cardiovascular Telemetry, Mobile Cardiovascular Outpatient Telemetry, Insertable Cardiac Monitor/Internal Loop Recorders, and Subcutaneous Cardiac Rhythm Monitors. They are differentiated by capabilities and the varying technical components among devices, such as intermittent/continuous recording, patient/rhythm activated recording, number of leads, time frames of use and whether the rhythm is interpreted in real time (attended surveillance) or if it is transferred from the device and interpreted at a later time. Regardless of the equipment, these devices provide valuable data for diagnosis of palpitations, syncope and other signs and symptoms suggestive of cardiac arrhythmia.

The scope of this LCD is to define the specific patient indications that support medical necessity for this type of monitoring.

Definitions

Acute Coronary Syndrome (ACS) – applies to patients with suspicion or confirmation of acute myocardial ischemia or infarction. It describes a large array of signs and symptoms that range from atypical chest discomfort, nonspecific electrocardiographic changes, normal cardiac biomarkers, non-ST-elevation myocardial infarction (NSTEMI), large ST-segment elevation myocardial infarction (STEMI), and cardiogenic shock. 1

Silent Myocardial Ischemia – is defined as ‘objective documentation of myocardial ischemia in the absence of angina or anginal equivalents.’ 2

24-hour Monitoring Station (applicable only to mobile cardiac telemetry) - is defined as a facility in operation 24-hours per day, seven days a week, with a receiving station staffed with EKG technicians or other non-physician staff on a 24-hour per day basis. The technicians should have immediate 24-hour access to a physician to review transmitted data that falls outside of set parameters. The technicians should know how to contact available facilities to assist in any cardiac emergencies. 3,4,5 .

Covered Indications

AECG monitoring, when performed with a device that has FDA clearance, will be considered medically reasonable and necessary in the following situations:

• A standard 12-lead electrocardiograph (ECG), complete cardiac history and cardiac exam has not satisfactorily explained the patient's cardiac complaints and AECG testing will provide diagnostic information that will assist in developing a treatment plan or changing a treatment plan for patients that are at risk for cardiac arrythmias. 3,6,7

OR

• For patients experiencing unexplained syncope, near syncope, episodic dizziness, chest pain, palpitations, and/or shortness of breath. 6

OR

• To assess documented or suspected bradycardia. 8

OR

• For patients experiencing nocturnal arrhythmias. 6

OR

• To assess the average heart rate and adequacy of rate control in a patient with atrial fibrillation. 6

OR

• To aid in the regulation of anti-arrhythmic drug dosage. 3,6,7,9

OR

• To assess the effectiveness of arrhythmia therapy (e.g., post ablation). 6

OR

• To evaluate prognosis following acute coronary syndrome. 6,10

OR

• Pre/Post implantable cardiac defibrillator reprogramming. 7

OR

• To assess for silent myocardial ischemia in a patient with known or suspected coronary heart disease. 3,6

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. 6,7

OR

• To evaluate for occult atrial fibrillation (A-Fib) as a potential cause of cardio-embolism in patients with cryptogenic stroke. 4,6

Note: A 24-48 hour monitor is most appropriate for patients with daily or near daily symptoms. 6 Otherwise, providers should order the most appropriate type of AECG for the patient based on their evaluation of the patient, the patient’s symptoms and the devices’ labeled indications.

Note: The duration of monitoring should be consistent with the patient’s signs and symptoms. 3,6,11,12,13

Limitations

The following are considered not medically reasonable and necessary:

• Devices that do not have FDA clearance, including non-physician prescribed; hand/wrist held – smart phone based devices.

• AECG monitoring of potentially harmful ventricular arrhythmias requiring inpatient level of care. 12,14

• Any 24-hour monitoring station that does not meet the definition in the definition section. 3,4,5

Please refer to NCD 20.15 for additional indications and limitations.

Provider Qualifications

Services will be considered medically reasonable and necessary when all aspects of care are within the scope of practice of the provider’s professional licensure, when performed according to the supervision requirements per state scope of practice laws, and when all procedures are performed by appropriately trained providers in the appropriate setting.

Notice: Services performed for any given diagnosis must meet the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.

Clinical Practice

Zimetbaum et al 14 provides an overview and evaluation for care with patients that present with palpitations. There are many factors to be considered in the etiology of palpitations. Cardiac disorders are the most common cause of palpitations and include arrhythmias, structural heart disease, conduction system abnormalities, valvular disease, pacemaker syndrome, atrial myoma, sympathetic stimulation and catecholamine release during exercise and high output cardiac states. Other etiology of palpitations may include psychiatric disorders, medication effects, substance abuse, endocrine disorders, and metabolic disorders.

The workup for a patient who presents with palpitations typically includes an extensive medical history along with a 12-lead ECG, physical exam and limited laboratory testing. 14(p3)

When an arrhythmia is not identified on the 12-lead ECG, the patient’s medical history can be helpful to note the age of symptom onset, duration of palpitations, heart rate and rhythm regularity, additional symptoms that are associated with the palpitations (pre-syncope or syncope), the onset and resolution of the palpitations, effects of positional changes and if the patient is able to alleviate the palpitations on their own. In addition, the cardiac exam should include the patient’s family cardiac history and co-existing medical conditions such as pregnancy, metabolic and endocrine issues, chronic obstructive pulmonary disease, and psychiatric disorders. 14(p2)