Ambulatory Event Monitors and Mobile Cardiac Outpatient Telemetry
There are a wide variety of devices available for outpatient cardiac rhythm monitoring. The primary purpose of these devices is to evaluate suspected arrhythmias that have not been detected by office- or hospital-based monitoring. These devices differ in the types of monitoring leads used, the duration and continuity of monitoring, the ability to detect arrhythmias without patient intervention, and the mechanism of delivery of the information from patient to clinician. These devices may be used to evaluate symptoms suggestive of arrhythmias (eg, syncope or palpitations), and may be used to detect atrial fibrillation (AF) in patients who have undergone cardiac ablation of AF or who have a history of cryptogenic stroke.
Indications for Ambulatory Cardiac Rhythm Monitoring
Ambulatory cardiac monitoring with a variety of devices allows for the evaluation of cardiac electrical activity over time, in contrast to a static electrocardiogram (ECG), which only permits the detection of abnormalities in cardiac electrical activity at a single point in time. Cardiac monitoring is routinely used in the inpatient setting for the purpose of detecting acute changes in heart rate or rhythm that may need urgent response. For some clinical conditions, a more prolonged period of monitoring in the ambulatory setting is needed to detect heart rate or rhythm abnormalities that may occur infrequently. These cases may include the diagnosis of arrhythmias in patients with signs and symptoms suggestive of arrhythmias. In addition, ambulatory cardiac monitoring may be used for evaluation of paroxysmal atrial fibrillation (AF).
Arrhythmia Detection in Patients With Signs/Symptoms of Arrhythmia
Cardiac arrhythmias may be suspected because of symptoms suggestive of arrhythmias, including palpitations, dizziness, syncope, or presyncope, or because of abnormal heart rate or rhythm noted on exam. A full discussion of the differential diagnosis and evaluation of each of these symptoms is beyond the scope of this policy, but some general principles on the use of ambulatory monitoring are discussed.
Arrhythmias are an important potential cause of syncope or near-syncope, which may in some cases be described as dizziness. An ECG is generally indicated whenever there is suspicion of a cardiac cause of syncope. Some arrhythmic causes will be apparent on ECG. However, in patients in whom an ECG is not diagnostic, longer monitoring may be indicated. The 2009 guidelines from the European Society of Cardiology suggest that in individuals with clinical or ECG features suggesting a arrhythmic syncope, ECG monitoring is indicated; they also state that the “duration (and technology) of monitoring should be selected according to the risk and the predicted recurrence rate of syncope.” Similarly, guidelines from the National Institute for Health and Care Excellence on the evaluation of transient loss of consciousness, published in 2010 and updated in 2014, recommends the use of an ambulatory ECG in individuals with a suspected arrhythmic cause of syncope, with the type and duration of monitoring chosen based on the individual’s history.
Similar to syncope, the evaluation and management of palpitations is patient-specific, but in cases where the initial history, examination, and ECG findings are suggestive of an arrhythmia, some form of ambulatory ECG monitoring is indicated. A 2011 position paper from the European Heart Rhythm Association indicates that for individuals with palpitations of unknown origin who have clinical features suggestive of arrhythmia, referral for specialized evaluation with consideration for ambulatory ECG monitoring is indicated.
Atrial Fibrillation Detection
AF is the most common arrhythmia in adults. It may be asymptomatic or be associated with a broad range of symptoms, including lightheadedness, palpitations, dyspnea, and a variety of more nonspecific symptoms (eg, fatigue, malaise). It is classified as paroxysmal, persistent, or permanent based on symptom duration. Diagnosed AF may be treated with antiarrhythmic medications with the goal of rate or rhythm control, direct cardioversion, catheter-based radiofrequency- or cryo-energy-based ablation, or one of several surgical techniques, depending on the patient’s comorbidities and associated symptoms.
AF is associated with the development of thrombi in the atria, often the left atrial appendage. Patients with AF are at risk for ischemic stroke due to the risk of embolism of the thrombus. Multiple clinical trials have demonstrated that anticoagulation reduces the ischemic stroke risk in patients at moderate or high risk of thromboembolic events. Oral anticoagulation in patients with AF reduces the risk of subsequent stroke and is recommended by American Heart Association and American College of Cardiology guidelines for patients with a history of stroke or transient ischemic attack.
Ambulatory ECG monitoring may play a role in several situations in the detection of AF. In patients who have undergone ablative treatment for AF, if ongoing AF can be excluded with reasonable certainty, including paroxysmal AF which may not be apparent on ECG during an office visit, anticoagulation therapy could potentially be stopped.
Patients with cryptogenic stroke are often monitored for the presence of AF, because AF is estimated to be the cause of cryptogenic stroke in more than 10% of patients, and AF increases the risk of stroke. Paroxysmal AF confers an elevated risk of stroke, just as persistent and permanent AF do. In individuals with a high risk of stroke, particularly those with a history of ischemic stroke that is unexplained by other causes, prolonged monitoring to identify paroxysmal AF has been investigated.
Cardiac Rhythm Ambulatory Monitoring Devices
A Holter monitor is worn continuously and records cardiac electrical output continuously throughout the recording period. Holter monitors are capable of recording activity for up to about 24 to 72 hours. Traditionally, most Holter monitors had 3 channels based on 3 ECG leads. However, some currently available Holter monitors have up to 12 channels. Holter monitors are an accepted intervention in a variety of settings where a short period (24-48 hours) of comprehensive cardiac rhythm assessment is needed (eg, suspected arrhythmias when symptoms [syncope, palpitations] are occurring daily). These devices are not the focus of this policy.
Various classes of devices are available for situations where longer monitoring than can be obtained with a traditional Holter monitor is needed. Because there may be many devices within each category, a comprehensive description of each device is beyond the scope of this policy. Specific devices may vary in how data are transmitted to the location where the ECG output is interpreted. Data may be transmitted via cellular phone or landline, or by direct download from the device after its return to the monitoring center. The device classes are described in the table below.
Ambulatory Cardiac Rhythm Monitoring Devices
There are also devices that combine features of multiple classes. For example, the LifeStar ACT Ex Holter (LifeWatch Services, Switzerland) is a 3-channel Holter monitor, but is converted to a mobile cardiac telemetry system if a diagnosis is inconclusive after 24 to 48 hours of monitoring. The BodyGuardian® Heart Remote Monitoring System (Preventice Services, Houston, TX) is an external autotriggered memory loop device that can be converted to a real-time monitoring system. The eCardio Verité™ system (eCardio, Houston, TX) can be changed between a patient-activated event monitor and a continuous telemetry monitor. The Spiderflash-T (LivaNova, London, England) is an example of an external autotriggered or patient-triggered loop recorder, but, like the ZioPatch, can record 2 channels for 14 to 40 days.
The use of patient-activated or auto-activated external ambulatory event monitors OR continuous ambulatory monitors that record and store information for periods longer than 48 hours may be considered medically necessary as a diagnostic alternative to Holter monitoring in the following situations:
The use of implantable ambulatory event monitors, either patient-activated or auto-activated, may be considered medically necessary in the following situations:
The use of outpatient cardiac telemetry (also known as mobile cardiac outpatient telemetry) as a diagnostic alternative to ambulatory event monitors in patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of cardiac arrhythmias (ie, palpitations, dizziness, presyncope, or syncope) is considered investigational.
Other uses of ambulatory event monitors, including outpatient cardiac telemetry, are considered investigational, including but not limited to monitoring effectiveness of antiarrhythmic medications and detection of myocardial ischemia by detecting ST segment changes.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
The available evidence suggests that long-term monitoring for atrial fibrillation after cryptogenic stroke or postablation is associated with improved outcomes, but the specific type of monitoring associated with the best outcomes is not well-defined. Trials that have demonstrated improved outcomes have used either event monitors or implantable monitors. In addition, there are individual patient considerations that may make one type of monitor preferable over another.
Therefore, for the evaluation of patients with cryptogenic stroke who have had a negative standard work-up for atrial fibrillation including 24-hour Holter monitoring, or for the evaluation of atrial fibrillation after an ablation procedure, the use of long-term monitoring with an external event monitor, OR a continuous ambulatory monitor that records and stores information for periods longer than 48 hours, OR an implantable ambulatory monitor may be considered medically necessary for patients who meet the criteria outlined above.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
2/1999: Implantable Continuous "Memory Loop" Devices policy approved by Medical Policy Advisory Committee (MPAC), CPT 33999 added
5/1999: MPAC expanded and renamed policy to include all Ambulatory Event Monitors
1/23/2002: Prior authorization deleted
2/15/2002: Investigational definition added
4/18/2002: Type of Service and Place of Service deleted
5/23/2002: Code Reference section updated, CPT 93012, 93014 added
8/4/2003: Code Reference section updated, HCPCS G0004-G0007, G00015 deleted
10/21/2004: Code Reference section updated, CPT 33999, 93012, 93014 deleted, CPT 93270, 93271, 93272 description revised, ICD-9 procedure code 86.05, 86.09 description revised, HCPCS G0015 deleted
10/25/2005: Policy clarified and re-titled
03/07/2006: Coding updated. HCPCS 2006 revisions added to policy
09/12/2006: Coding updated. ICD9 2006 revisions added to policy
1/3/2007: Policy reviewed, policy section clarified
5/11/2007: Policy reviewed. Policy section updated; no change to policy statements
12/24/2008: Coding reference section updated per the 2009 CPT/HCPCS revisions
5/14/2009: Outpatient cardiac telemetry (MCOT) changed from "investigational" to "not medically necessary"
04/12/2010: Description section revised with other outpatient cardiac telemetry systems. Coding Section revised to add CPT Codes 93228 and 93229 and ICD-9 Diagnosis codes 427.0, 427.1, 427.2, 427.31, 427.32, 427.41, 427.42, 427.61, 427.69 and 427.81 to the Covered Codes Table. Also identified HCPCS Codes S0345, S0346 & S0347 were deleted as of 12/31/2009.
10/21/2010: Policy reviewed; no changes.
03/10/2011: Added ICD-9 code 785.0 to the Covered Codes table.
01/17/2012: Added the following policy statement: The use of auto-activated external ambulatory event monitors may be considered medically necessary in patients treated for atrial fibrillation to monitor for asymptomatic episodes in order to evaluate treatment response. Deleted outdated references from the Sources section. Removed deleted HCPCS codes S0345, S0346, and S0347 from the Code Reference section.
02/20/2013: Policy description updated regarding available devices. Policy statement revised to add patients with cryptogenic stroke to the last investigational statement. Added the following policy statement: Continuous ambulatory monitors that record and store information for periods longer than 72 hours are considered investigational. The first policy statement was re-worded to add patient-activated or auto-activated monitors. The policy statement regarding use of event monitors in patients with atrial fibrillation treated with catheter ablation was revised for clarity purposes.
04/22/2014: Policy statement revised to state that continuous ambulatory monitors that record and store information for periods longer than 48 hours are considered investigational. It previously stated longer than 72 hours.
09/22/2014: Added new medically necessary policy statement for patients with cryptogenic stroke who have a negative standard work-up for atrial fibrillation including a 24-hour Holter monitor. Added "to ambulatory event monitors" to the outpatient cardiac telemetry policy statement.
02/02/2015: Policy description updated regarding devices. Removed "Holter monitor" from the policy statement regarding the use of implantable ambulatory event monitors. Revised the following statement: Outpatient cardiac telemetry (also known as mobile cardiac outpatient telemetry or MCOT) as a diagnostic alternative to ambulatory event monitors in patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of cardiac arrhythmias (ie, palpitations, dizziness, presyncope, or syncope) are expected to result in outcomes that are equivalent to alternatives such as autotrigger devices, but may be more costly than alternatives. In this situation, the more costly alternative may be considered not medically necessary. Policy statement regarding the use of continuous ambulatory monitors changed from investigational to medically necessary with certain criteria. Investigational policy statement revised to change "antiarrhythmic therapy" to "antiarrhythmic medications" and remove "for patients with cryptogenic stroke." Policy guidelines updated regarding health outcomes for MCOT and alternative methods.
05/19/2015: Removed ICD-9 procedure codes 86.05, 86.09, and 89.50 from the Code Reference section.
08/14/2015: Medical policy revised to add ICD-10 codes. Added ICD-9 procedure code 37.79 and ICD-9 diagnosis code 434.91 to the Code Reference section.
11/11/2015: Policy description updated regarding devices and technologic advances. Medically necessary policy statement regarding the use of implantable ambulatory event monitors updated to add patients with cryptogenic stroke. Policy statement regarding the use of outpatient cardiac telemetry changed from "not medically necessary" to "investigational." Policy guidelines updated to clarify that for the evaluation of patients with cryptogenic stroke, either the use of an external long term monitor or an implantable monitor (but not both) may be considered medically necessary. Added medically necessary and investigative definitions.
06/06/2016: Policy number added.
07/22/2016: Policy description rewritten. Medically necessary policy statements regarding continuous ambulatory monitors with longer recording periods and external ambulatory event monitors combined into one statement. Policy statement updated to state that the use of implantable ambulatory event monitors may be considered medically necessary in patients who require long-term monitoring for atrial fibrillation or possible fibrillation. Policy Guidelines updated regarding long-term monitoring for atrial fibrillation.
08/15/2016: Code Reference section updated to add CPT codes 0295T, 0296T, 0297T, and 0298T.
Blue Cross Blue Shield Association Policy #2.02.08
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.