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There are a wide variety of devices available for outpatient cardiac rhythm monitoring. The primary purpose of these devices is the evaluation of 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 for the evaluation of symptoms suggestive of arrhythmias, such as syncope or palpitations, but also may be used in the detection of atrial fibrillation (AF) in patients who have undergone cardiac ablation of AF or who have a history of cryptogenic stroke.
A variety of cardiac monitors are available for the evaluation of patients with potential arrhythmias. Signs and symptoms potentially suggestive of arrhythmias include palpitations, dizziness, syncope, or presyncope, or abnormal heart rate or rhythm noted on exam. In addition, because of the association between atrial fibrillation (AF) and stroke or transient ischemic attack (TIA), monitoring for asymptomatic AF is often part of the evaluation for the cause of a stroke or TIA.
A brief description of the major categories of devices is given next. There has been a trend in recent years toward using novel technology to increase the efficiency, comfort, and convenience of these devices. These technologic advances include the development of devices that are smaller and more convenient to use, as well as novel ways to rapidly transmit information, such as by use of mobile devices. These advances in technology may present challenges in categorizing new devices.
Some of the newer devices are described next for informational purposes in assigning them to the most relevant category. However, because there may be many devices within each category, a comprehensive description of individual devices is beyond the scope of this policy.
Continuous Monitoring Devices (Holter Monitors and Similar Devices)
Ambulatory Holter electrocardiography (ECG) is a widely used noninvasive test in which ECG is continuously recorded over an extended period of time, typically 24 to 48 hours, to evaluate symptoms suggestive of cardiac arrhythmias (i.e., palpitations, dizziness, syncope). However, Holter monitoring will be ineffective in detecting arrhythmias if a patient experiences infrequent symptoms. Therefore, the sensitivity of Holter monitoring is low for detection of arrhythmias that are intermittent.
Continuous Monitoring Devices with Longer Recording Periods
Some newer devices are continuous monitors that are similar to traditional Holter monitoring in concept, but offer other advantages such as the ability to monitor for longer periods of time.
Non-Continuous Monitoring Devices (Ambulatory Event Monitors and Similar Devices)
Ambulatory event monitors (AEMs) were developed to provide longer periods of monitoring by using noncontinuous monitoring. In this technique, the recording device is either worn continuously and activated only when the patient experiences symptoms or is carried by the patient and applied and activated when symptoms are present. The recorded ECGs are then stored for future analysis or transmitted by telephone to a receiving station (e.g., a doctor's office, hospital, cardiac monitoring service) where the ECGs can then be analyzed. AEMs can be used for extended periods of time, typically up to one month or until the patient experiences symptoms. Since the ECGs are recorded only during symptoms, there is good correlation with any underlying arrhythmia. Conversely, if no ECG abnormality is noted, a non-cardiac etiology of the patient's symptoms can be sought.
Several different types of AEMs are available:
1. Noncontinuous Devices with Memory
These devices are carried by the patient and applied to the precordial area via nongel electrodes when the symptoms are occurring or, alternatively, a recording device may be worn on the wrist and then activated when symptoms are present. The limitation of these devices is that an arrhythmia of very short duration would be difficult to record. In addition, noncontinuous devices require reasonable dexterity on the part of the patient to apply the device correctly during a symptomatic period. This is a particular limitation if the patient is incapacitated during symptomatic periods.
2. Continuous "Memory Loop" Devices
These devices are able to continuously store a single channel of ECG data in a refreshed memory. If the patient activates the device, the ECG is then recorded from the memory loop for the preceding 30 to 90 seconds and for the next minute or so. Therefore, these types of devices permit recording of the onset of arrhythmias and/or transient or incapacitating events. They obviously must be worn continuously.
3. Implantable Continuous "Memory Loop" Devices
An implantable loop recorder device is inserted just under the patient's skin in the chest area during an outpatient surgical procedure. When symptoms are felt, the patient places a hand-held activator over the recorder to activate the storage of cardiac rhythms. This device can be used for more than one year.
4. Auto-trigger Devices
All of the previously described devices require activation by the patient. More recently, auto-triggering technology has become available, which can be adapted to memory loop devices. For example, event monitors can be programmed to detect heart rates greater than 165 beats per minute, less than 40 beats per minute, or an asystole of greater than 3 seconds.
5. Implantable Continuous “Memory Loop” Devices with Autotrigger
These devices combine the long-term monitoring available with implantable devices with the autotriggers seen on newer event monitors. These devices contain algorithms that are programmed to detect heart rates exceeding an upper or lower limit, asystole of greater than 3 seconds. They typically contain other autotriggers, such as a variable RR interval seen with atrial fibrillation. For example, the Reveal® XT ICM (Medtronic Inc., Minneapolis, MN) is an implantable memory loop device cleared for marketing by the U.S. Food and Drug Administration (FDA) in 2008 that allows patient-activated rhythm recording, rhythm recording at prespecified time intervals, or autotriggered rhythm recording. Sizes of implantable devices are decreasing: in February 2014, FDA cleared for marketing the Reveal LINQ™, a miniaturized implantable memory loop device that is approximately 1 mL that includes autotriggered or patient-activated rhythm recording.
Mobile Cardiac Outpatient Telemetry
Ambulatory event monitors store the recorded data, which is ultimately transmitted either to a physician's office or to a central recording station. In contrast, outpatient cardiac telemetry provides real-time monitoring and analysis. For example, CardioNet® now owned by BioTelemetry (Malvern, PA), offers Mobile Cardiac Outpatient Telemetry. In this system, the patient wears a three-lead sensor, which constantly communicates with the CardioNet monitor, a lightweight unit that can be carried in a pocket or a purse. When an arrhythmia is detected according to preset parameters, the ECG is automatically transmitted to a central CardioNet service center, where the ECG is immediately interpreted, with results sent to the referring physician. The referring physician can request the level and timing of response, ranging from daily reports to stat results. Other systems for outpatient cardiac telemetry include the HEARTLink II™ system (Cardiac Telecom), the Vital Signs Transmitter (VST™; Biowatch Medical, Columbia, SC), the LifeStar™ Ambulatory Cardiac Telemetry (ACT) system (Card Guard Scientific Survival, Israel), and the SEEQ™ Mobile Cardiac Telemetry System (Medtronic, Minneapolis, MN). The eCardio Verité™ system (eCardio, Houston, TX) is a multifunctional model that can be changed between a patient-activated event monitor and a continuous telemetry monitor.
The VectraplexECG™ System is a real-time continuous Mobile Cardiac Outpatient Telemetry device to measure ischemic ECG changes that can be indicative of a myocardial infarction. This device utilizes the Internet to communicate real-time ECG changes to the physician. The patient is hooked up to a mini-tablet by either 5 electrodes, which communicate 15-lead ECG data, or 10 electrodes that communicate 12-lead ECG data. While this system is primarily intended to monitor for ischemia, the continuous ECG monitoring would presumably detect rhythm disturbances, as well as ischemic changes.
The use of patient-activated or auto-activated external ambulatory event monitors 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 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) is considered investigational.
The use of 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 or patient-activated or auto-activated external ambulatory event monitors in the following situations:
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.
For the evaluation of patients with cryptogenic stroke who have had a negative standard work-up for atrial fibrillation including 24-hour Holter monitoring, 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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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.
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.