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Ambulatory Event Monitors and Mobile Cardiac Outpatient Telemetry

Policy Number: MP-356

 

Latest Review Date:   June 2020

Category:  Medical                                                                

Policy Grade:  B

 

POLICY:

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:

  • Patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of cardiac arrhythmias (i.e., palpitations, dizziness, presyncope, or syncope); OR
  • Patients with atrial fibrillation who have been treated with catheter ablation, and in whom discontinuation of systemic anticoagulation is being considered; OR
  • Patients with cryptogenic stroke who have a negative standard work-up for atrial fibrillation including a 24-hour Holter monitor.

 

The use of implantable ambulatory event monitors, either patient-activated or auto-activated, may be considered medically necessary in the following situations:

  • In the small subset of patients who experience recurrent symptoms so infrequently that a prior trial of other external ambulatory event monitors has been unsuccessful; OR
  • In patients with cryptogenic stroke who have had a negative standard work-up for atrial fibrillation including a 24-hour Holter monitor; OR
  • For the evaluation of atrial fibrillation after an ablation procedure

 

The use of outpatient cardiac telemetry (also known as mobile cardiac outpatient telemetry or MCOT) is considered not medically necessary and investigational as a diagnostic alternative to ambulatory event monitors in patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of cardiac arrhythmias (i.e., palpitations, dizziness, presyncope, or syncope).

 

Other uses of ambulatory event monitors (including outpatient cardiac telemetry) and mobile applications, including but not limited to monitoring asymptomatic patients with risk factors for arrhythmia, monitoring effectiveness of antiarrhythmic medications and detection of myocardial ischemia by detecting ST- segment changes are considered not medically necessary and investigational.

 

For Holter monitors, please refer to MP# 461- Holter Monitoring (Ambulatory Electrocardiography)

 

 

DESCRIPTION OF PROCEDURE OR SERVICE:

Various devices are available for outpatient cardiac rhythm 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.

 

Cardiac Arrhythmias

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 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).

 

Cardiac arrhythmias may be suspected because of symptoms suggestive of arrhythmias, including palpitations, dizziness, or 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 review, 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 joint guidelines from the European Society of Cardiology and 3 other societies, suggest that in individuals with clinical or ECG features suggesting an 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 (2014) on the evaluation of transient loss of consciousness, have recommended the use of an ambulatory ECG in individuals with a suspected arrhythmic cause of syncope. The type and duration of monitoring recommended is based on the individual’s history, particularly the frequency of transient loss of consciousness. The Holter monitor is recommended if transient loss of consciousness occurs several times a week. If the frequency of transient loss of consciousness is every one to two weeks, an external event recorder is recommended; and if the frequency is less than once every two weeks, an implantable event recorder is recommended.

 

Similar to syncope, the evaluation and management of palpitations is patient-specific. 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 (AF) 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 (e.g., 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.

 

Stroke in AF occurs primarily as a result of thromboembolism from the left atrium. The lack of atrial contractions in AF leads to blood stasis in the left atrium, and this low flow state increases the risk of thrombosis. The area of the left atrium with the lowest blood flow in AF, and therefore the highest risk of thrombosis, is the left atrial appendage. 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 was recommended by American Heart Association, American College of Cardiology, and Heart Rhythm Society (2014) joint guidelines on 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. In some cases where identifying paroxysmal AF is associated with potential changes in management, longer term monitoring may be considered. There are well-defined management changes that occur in patients with AF. However, until relatively recent the specific role of long-term (i.e., >48 hours) monitoring in AF was not well-described.

 

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

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.

 

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 (e.g., suspected arrhythmias when symptoms [syncope, palpitations] are occurring daily). These devices are not the focus of this review.

 

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 our scope. 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 Table 1.

 

Table 1: Ambulatory Cardiac Rhythm Monitoring Devices

Device Class

Description

Example Devices

Noncontinuous devices with memory (event recorder)

 

Devices not worn continuously but rather activated by patient and applied to skin in the precordial area when symptoms develop

  • Zio® Event Card (iRhythm Technologies, San Francisco, CA)
  • REKA E100™ (REKA Health, Bridgewater, NJ)

Continuous recording devices with longer recording periods

Devices continuously worn and continuously record via ≥1 cardiac leads and store data for a longer period than traditional Holter (14 d)

  • Zio® Patch system (iRhythm Technologies, San Francisco, CA)

 

External memory loop devices (patient- or autotriggered)

Devices continuously worn and continuously store a single channel of ECG data in a refreshed memory. If device is activated, the ECG is then recorded from the memory loop for the preceding 30-90 s and for next minute or so. These devices may be activated by a patient when symptoms occur (patient-triggered) or by an automated algorithm when changes suggestive of an arrhythmia are detected (autotriggered).

  • Patient-triggered: Explorer™ Looping Monitor (LifeWatch Services, Switzerland)
  • Autotriggered: LifeStar AF Express™ Auto-Detect Looping Monitor (LifeWatch Services, Switzerland)
  • Autotriggered or patient-triggered: King of Hearts Express® AF (Card Guard Scientific Survival, Rehovot, Israel)

Implantable memory loop devices (patient- or autotriggered)

Devices similar in design to external memory loop devices but implanted under the skin in the precordial region

  • Autotriggered: Reveal® XT ICM (Medtronic, Minneapolis, MN)
  • Autotriggered: BioMonitor, Biotronik SE (Berlin, Germany)

 

Mobile cardiac outpatient telemetry

Continuously recording or autotriggered memory loop devices that transmit data to a central recording station with real-time monitoring and analysis

  • CardioNet MCOT (BioTelemetry, Malvern, PA)
  • LifeStar Mobile Cardiac Telemetry (LifeWatch Services, Switzerland)
  • SEEQ Mobile Cardiac Telemetry (Medtronic, Minneapolis, MN)

ECG: electrocardiogram

 

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.

 

 

KEY POINTS:

The most recent review covers the period through May 1, 2020.

 

Summary of Evidence

Ambulatory Event Monitoring

For individuals with signs and/or symptoms suggestive of arrhythmia(s) who receive patient- or auto-activated external ambulatory event monitoring or continuous ambulatory monitoring storing information for more than 48 hours, the evidence includes 1 RCT and prospective and retrospective studies reporting on the diagnostic yield. Relevant outcomes are overall survival and morbid events. The RCT and the observational studies have consistently shown that continuous monitoring with longer recording periods detect more arrhythmias than 24- or 48-hour Holter monitoring. Particularly for patients in who would, without the more prolonged monitoring, only undergo shorter term monitoring, the diagnostic yield is likely to identify arrhythmias that may have therapeutic implications. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

 

For individuals with atrial fibrillation (AF) following ablation who receive long-term ambulatory cardiac monitoring, the evidence includes 1 RCT comparing ambulatory event monitoring to standard care and several observational studies. Relevant outcomes are overall survival, morbid events, medication use, and treatment-related morbidity. The RCT evaluating a long-term monitoring strategy after catheter ablation for AF reported significantly higher rates of AF detection. The available evidence suggests that long-term monitoring for AF after postablation is associated with improved outcomes. However, the specific type of monitoring associated with the best outcomes is not established, because different long-term monitoring devices were used across the studies. Trials that have demonstrated improved outcomes have used event monitors or implantable monitors. In addition, there are individual patient considerations that may make 1 type of monitor preferable over another. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

 

For individuals who have cryptogenic stroke with a negative standard workup for AF who receive long-term ambulatory cardiac monitoring, the evidence includes systematic reviews of RCTs comparing ambulatory event monitoring with standard care. Relevant outcomes are overall survival, morbid events, medication use, and treatment-related morbidity. RCTs evaluating a long-term AF monitoring strategy poststroke have reported significantly higher rates of AF detection with longer term ambulatory monitoring. The available evidence has suggested that long-term monitoring for AF after cryptogenic stroke is associated with improved outcomes, but the specific type of monitoring associated with the best outcomes is not established, because different long-term monitoring devices were used across the studies. Trials demonstrating improved outcomes have used event monitors or implantable monitors. In addition, there are individual patient considerations that may make one type of monitor preferable over another. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

 

For individuals who are asymptomatic with risk factors for AF who receive long-term ambulatory cardiac monitoring, the evidence includes an RCT and observational studies. Relevant outcomes are overall survival, morbid events, medication use, and treatment-related morbidity. The studies showed use of the ambulatory monitors would result in higher AF detection compared with routine care. However, the RCT followed patients for one year and did not detect a difference in stroke occurrence between the monitored group and the standard of care group. The other studies did not discuss changes in patient management or health outcomes based on monitoring. Studies reporting on improved outcomes with longer follow-up are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

 

Implantable Loop Recording (ILR)

For individuals with signs and/or symptoms suggestive of arrhythmia with infrequent symptoms who receive patient- or auto-activated implantable ambulatory event monitoring, the evidence includes RCTs comparing implantable loop recorders (ILRs) with shorter term monitoring, usually 24- to 48-hour Holter monitoring. Relevant outcomes are overall survival, morbid events, medication use, and treatment-related morbidity. Studies assessing prolonged ILRs in patients have reported high rates of arrhythmia detection compared with external event monitoring or Holter monitoring. These studies support use of a progression in diagnostics from an external event monitor to ILR when longer monitoring is needed. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

 

Outpatient Cardiac Telemetry

For individuals with signs and/or symptoms suggestive of arrhythmia who receive outpatient cardiac telemetry, the evidence includes 1 RCT and nonrandomized studies evaluating rates of arrhythmia detection with outpatient cardiac telemetry. Relevant outcomes are overall survival and morbid events. The available evidence has suggested that outpatient cardiac telemetry is at least as good at detecting arrhythmias as ambulatory event monitoring. However, studies have not evaluated whether the real-time monitoring feature of outpatient cardiac telemetry leads to reduced cardiac events and mortality. The evidence is insufficient to determine the effects of the technology on health outcomes.

 

Practice Guidelines and Position Statements

International Society for Holter and Noninvasive Electrocardiology et al

In 2017, the International Society for Holter and Noninvasive Electrocardiology and the Heart Rhythm Society (HRS) issued a consensus statement on ambulatory electrocardiogram and external monitoring and telemetry. Below are two summary tables from the consensus statement, detailing advantages and limitations of ambulatory electrocardiogram techniques (see Table 2) and recommendations for the devices that are relevant to this evidence review (see Tables 3).

 

 

Table 2. Advantages and Limitations of Ambulatory ECG Techniques, International Society for Holter and Noninvasive Electrocardiology/HRS

ECG Monitoring Technique

Advantages

Limitations

Holter monitoring

  • Records and documents continuous 3- to 32-lead ECG signal simultaneously with biologic signals during normal daily activities
  • Physicians familiar with analysis software and scanning services
  • Frequent noncompliance with symptom logs and event markers
  • Frequent electrode detachments
  • Signal quality issues due to skin adherence, tangled wires, dermatitis
  • Absence of real-time data analysis
  • Poor patient acceptance of electrodes

Patch ECG monitors

  • Long-term recording of ≥14 d
  • Excellent patient acceptance
  • Limited ECG from closely spaced electrodes, lacking localization of arrhythmia origin
  • Inconsistent ECG quality due to body type variations

External loop recorders

  • Records only selected ECG segments marked as events either automatically or manually by patient
  • Immediate alarm generation on event detection
  • Single-lead ECG, lacking localization of arrhythmia origin
  • Cannot continuously document cardiac rhythm
  • Requires patient to wear electrodes continuously

Event recorders

  • Records only selected ECG segments after an event is detected by patient
  • Immediate alarm generation at event detected by patient
  • Well-tolerated by patient
  • Single-lead ECG, lacking localization of arrhythmia origin
  • Cannot continuously document cardiac rhythm
  • Diagnostic yield dependent on patient ability to recognize correct symptom

 Mobile cardiac telemetry

  • Multilead, so higher sensitivity and specificity of arrhythmia detection
  • Streams data continuously; can be programmed to auto detect and auto send events at prescribed time intervals
  • Immediate alarm generation on event without patient interaction
  • Long-term patient acceptance is reduced due to requirement of daily electrode changes

ECG: electrocardiogram.

 

Table 3. Select Recommendations for Ambulatory ECG and External Monitoring or Telemetry, International Society for Holter and Noninvasive Electrocardiology/HRS

Recommendation

CORa

LOEb

Selection of ambulatory ECG

 

 

Holter monitoring when symptomatic events anticipated within 48 h

I

B-NR

Extended ambulatory ECG (15-30 d) when symptomatic events are not daily or are uncertain

I

B-R

Continuous monitoring (1-14 d) to quantify arrhythmia burden and patterns

I

B-NR

Specific conditions for use of ambulatory ECG

 

 

Unexplained syncope, when tachycardia suspected

I

B-R

Unexplained palpitation

I

B-R

Detection of AF, triggering arrhythmias, and post-conversion pauses

IIa

B-NR

Cryptogenic stroke, to detect undiagnosed AF

I

B-R

AF: atrial fibrillation; ECG: electrocardiogram; COR: class of recommendation; LOE: level of evidence. a COR definitions: I: strong recommendation; IIa: benefit probably exceeds risk. b LOE definitions: B-NR: moderate level based on well-executed nonrandomized studies; B-R: moderate level based on randomized trials.

 

American College of Cardiology, American Heart Association et al

In 2019, the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Rhythm Society updated guidelines issued in 2014 on the management of patients with AF. These guidelines recommend the use of Holter or event monitoring if the diagnosis of the type of arrhythmia is in question or as a means of evaluating rate control.

 

The same associations collaborated on guidelines in 2017 on the evaluation and management of patients with syncope and patients with ventricular arrhythmias. Cardiac monitoring recommendations are summarized below in Tables 4 and 5.

 

 

Table 4. Cardiac Monitoring Recommendations for Patients with Syncope

Recommendation

CORa

LOEb

Choice of a specific cardiac monitor should be determined on the basis of frequency and nature of syncope events.

I

C-EO

To evaluate selected ambulatory patients with syncope of suspected arrhythmic etiology, the following external cardiac monitoring approaches can be useful: Holter monitor, transtelephonic monitor, external loop recorder, patch recorder, and MCOT.

IIa

B-NR

To evaluate selected ambulatory patients with syncope of suspected arrhythmic etiology, an implantable cardiac monitor can be useful

IIa

B-R

Ambulatory electrocardiographic monitoring is useful to evaluate whether symptoms including palpitations, presyncope, or syncope, are caused by VA

I

B-NR

In patients with cryptogenic stroke (i.e., stroke of unknown cause), in whom external ambulatory monitoring is inconclusive, implantation of a cardiac monitor (loop recorder) is reasonable to optimize detection of silent AF.

IIa

B-R

COR: class of recommendation; LOE: level of evidence; MCOT: mobile cardiac outpatient telemetry. a COR definitions: I: strong recommendation; IIa: benefit probably exceeds risk. b LOE definitions: B-NR: moderate level based on well-executed nonrandomized studies; B-R: moderate level based on randomized trials; C-EO: consensus of expert opinion based on clinical experience.

 

 

Table 5. Patient Selection Recommendations by Cardiac Rhythm Monitor

Type of Monitor

Patient Selection

Holter monitor

Symptoms frequent enough to be detected within 24 to 72 h

Patient-activated event monitor

  • Frequent spontaneous symptoms likely within 2 to 6 wk
  • Limited use when syncope associated with sudden incapacitation

External loop recorder (patient or autotriggered)

Frequent spontaneous symptoms likely to occur within 2 to 6 wk

External patch recorder

  • Alternative to external loop recorder
  • Leadless, so more comfortable, resulting in improved compliance
  • Offers only 1-lead recording

Mobile cardiac outpatient telemetry

  • Spontaneous symptoms related to syncope and rhythm correlation
  • High-risk patients needing real-time monitoring

Implantable cardiac monitor

Recurrent, infrequent, unexplained syncope

 

 

Heart Rhythm Society, European Heart Rhythm Association, et al

A consensus document on catheter and surgical ablation for atrial fibrillation was published in 2012 by the Heart Rhythm Society, the European Heart Rhythm Association, and the European Cardiac Arrhythmia Society and updated in 2017.  This document did not contain formal clinical practice guidelines, but provided general recommendations based on literature review and expert consensus. The use of AEMs post-ablation was addressed in two sections of the document. First, in the section discussing the use of anticoagulation following ablation, the following statement was made:

  • Patients in whom discontinuation of systemic anticoagulation is being considered based on patient values and preferences should consider undergoing continuous  or frequent ECG monitoring to screen for Atrial Fibrillation recurrence.

 

In the section of the document dealing with postoperative rhythm monitoring of patients who are post-ablation the following statements were made:

“The success of AF ablation is based in large part on freedom from AF recurrence based on ECG monitoring. Arrhythmia monitoring can be performed with the use of noncontinuous or continuous ECG monitoring tools.”

 

The statement referenced a table of ambulatory cardiac monitoring devices (Holter, patch, external loop, implantable loop, wearable multisensors, Smartphone monitors), describing unique features of each. The table did not evaluate the safety or efficacy of these devices, nor recommend one over another.

 

European Heart Rhythm Association

In 2009, EHRA published guidelines on the use of diagnostic implantable and external loop recorders. For the indications that EHRA considered established at the time of publication, the guidelines make the following statements about indications for implantable and external recorders:

 

Class I recommendations:

  • “ILR [implantable loop recorder] is indicated:
    • “In an early phase of evaluation of patients with recurrent syncope of uncertain origin who have:
      • “absence of high-risk criteria that require immediate hospitalization or intensive evaluation…”; and
      • “a likely recurrence within battery longevity of the device (LOE A).”
  •  “ELRs [external loop recorders] are indicated in patients with recurrent palpitations, undocumented by conventional ECG techniques, who have: inter-symptom interval <4 weeks and absence of high-risk criteria…which require immediate hospitalization or intensive evaluation (LOE B).”

 

Class IIa recommendations:

  • “ILR may be indicated to assess the contribution of bradycardia before embarking on cardiac pacing in patients with suspected or certain neurally mediated syncope presenting with frequent or traumatic syncopal episodes (Level of evidence B).”
  • “ILRs may be indicated in selected cases with severe infrequent symptoms when ELRs and other ECG monitoring systems fail to document the underlying cause (Level of evidence B).”
  • “ELRs [external loop recorder] may be indicated in patients with recurrent (pre)syncopes who have:
      • “inter-symptom interval of ≤4 weeks, and
      • “suspicion of arrhythmic origin and
      • “absence of high-risk criteria that require immediate hospitalization or intensive evaluation… (Level of evidence B).”

 

American Academy of Neurology

In 2014, the American Academy of Neurology released updated guidelines on the prevention of stroke in patients with nonvalvular atrial fibrillation (NVAF). These guidelines make the following recommendations regarding the identification of patients with occult NVAF:

  • Clinicians might obtain outpatient cardiac rhythm studies in patients with cryptogenic stroke without known NVAF, to identify patients with occult NVAF (Level of evidence: C).
  • Clinicians might obtain cardiac rhythm studies for prolonged periods (e.g., for one or more weeks) instead of shorter periods (e.g., 24 hours) in patients with cryptogenic stroke without known NVAF, to increase the yield of identification of patients with occult NVAF (Level of evidence: C).

 

U.S. Preventive Services Task Force Recommendations

Not applicable.

 

 

KEY WORDS:

Ambulatory device monitors, continuous “memory loop” devices, implantable continuous “memory loop” devices, Reveal ® XT ICM, autotriggered devices, ambulatory event monitors, autotrigger, loop recorder, ER920W, Zio™ Event Card, ER920W Wireless. HeartrackSmart™ Wireless, Genesis 30-day Event Monitor, Cardio R® device, REKA E100™ system, Reveal LINQ™, Explorer™ Looping Monitor, LifeStar AF Express™ Auto-Detecting Looping Monitor, LifeWatch, Mobile outpatient cardiac telemetry, MCOT, outpatient cardiac telemetry, OCT, Verite´, Zio® Patch, Zio™ ECG Utilization Service, ZEUS, VectraplexECG™, BodyGuardian Remote Monitoring System™, HeartLinkII™, VST™, LifeStar™ ACT, CardioNet®, SEEQ™

 

 

APPROVED BY GOVERNING BODIES:

Some of the newer devices are described in the Description section for informational purposes. However, because there may be many devices within each category, a comprehensive description of individual devices is beyond the scope of this review.

 

 

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

 

 

CURRENT CODING: 

CPT Codes:

The implantation and removal of an insertable loop recorder are coded as follows:

 

33285

Insertion, subcutaneous cardiac rhythm monitor, including programming (Effective 01/01/2019)

33286

Removal, subcutaneous cardiac rhythm monitor (Effective 01/01/2019)

 

 

The interpretation of the electrocardiograms recorded with AEMs may be coded as follows:

93268

External patient and, when performed, auto- activated electrocardiographic rhythm derived event recording with  symptom related memory loop with remote download capability up to 30 days, 24-hour attended monitoring;  includes transmission review and interpretation by a physician or other qualified health care professional.

 

 

Other CPT codes that can be used for AEM monitoring represent unbundling of the 93268 code:

 

93270

; recording (includes connection, recording and disconnection)

93271

; monitoring, transmission download and analysis

93272

; review and interpretation by a physician or other qualified health care professional.

 

 

There are specific CPT codes for mobile outpatient cardiac telemetry:

 

93228

External mobile cardiovascular telemetry with electrocardiographic recording, concurrent computerized real time data analysis and greater than 24 hours of accessible ECG data storage (retrievable with query) with ECG triggered and patient selected events transmitted to a remote attended surveillance center for up to 30 days; review and interpretation with report by a physician or other qualified health care professional

 

93229

; technical support for connection and patient instructions for use, attended surveillance, analysis and transmission of daily and emergent data reports as prescribed by a physician or other qualified health care professional

 

 

There are category III CPT codes for devices with longer recording capabilities:

 

0295T

External electrocardiographic recording for more than 48 hours up to 21 days by continuous rhythm recording and storage; includes recording, scanning analysis with report, review and interpretation (Effective 01/01/2012)

0296T

External electrocardiographic recording for more than 48 hours up to 21 days by continuous rhythm recording and storage; recording (includes connection and initial recording) (Effective 01/01/2012)

0297T

External electrocardiographic recording for more than 48 hours up to 21 days by continuous rhythm recording and storage; scanning analysis with report (Effective 01/01/2012)

0298T

External electrocardiographic recording for more than 48 hours up to 21 days by continuous rhythm recording and storage; review and interpretation (Effective 01/01/2012)

 

 

HCPCS Codes:

 

E0616

Implantable cardiac event recorder with memory, activator and programmer

 

 

PREVIOUS CODING:

 

33282

Implantation of patient-activated cardiac event recorder (Deleted 12/31/18)

33284

Removal of an implantable, patient-activated cardiac event recorder (Deleted 12/31/18)

 

 

REFERENCES:

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  11. Calkins H, Kuck KH, Cappato R et al. 2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design. J Interv Card Electrophysiol 2012; 33(2):171-257.
  12. Chao TF, Lin YJ, Tsao HM et al. CHADS(2) and CHA(2)DS(2)-VASc scores in the prediction of clinical outcomes in patients with atrial fibrillation after catheter ablation. J Am Coll Cardiol 2011; 58(23):2380-5.
  13. Christensen LM, Krieger DW, Hojberg S, et al. Paroxysmal atrial fibrillation occurs often in cryptogenic ischaemic stroke. Final results from the SURPRISE study. Eur J Neurol. Jun 2014; 21(6):884-889.
  14. Ciconte G, Saviano M, Giannelli L, et al. Atrial fibrillation detection using a novel three-vector cardiac implantable monitor: the atrial fibrillation detect study. Europace. Jul 1 2017; 19(7):1101-1108.
  15. Cotter PE, Martin PJ, Ring L, et al. Incidence of atrial fibrillation detected by implantable loop recorders in unexplained stroke. Neurology. Apr 23 2013; 80(17):1546-1550.
  16. Crawford MH, Bernstein SJ, Deedwania PC et al. ACC/AHA Guidelines for the ambulatory electrocardiography. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (committee to Revise the Guidelines for Ambulatory Electrocardiography).  J Am Coll Cardiol 1999; 34(3):912-45. 
  17. Culebras A, Messe SR, Chaturvedi S, et al. Summary of evidence-based guideline update: prevention of stroke in nonvalvular atrial fibrillation: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. Feb 25 2014; 82(8):716-724.
  18. DaCosta a, Defaye P, Romeyer-Bouchard C et al. Clinical impact of the implantable loop recorder in patients with isolated syncope, bundle branch block and negative workup:  a randomized multicentre prospective study. Arch Cardiovasc Dis 2013; 106(3); 145-54. 
  19. Dagres N, Kottkamp H, Piorkowski C et al. Influence of the duration of Holter monitoring on the detection of arrhythmia recurrences after catheter ablation of atrial fibrillation: implications for patient follow-up. Int J Cardiol 2010; 139(3):305-6.
  20. Derkac WM, Finkelmeier JR, Horgan DJ, et al. Diagnostic yield of asymptomatic arrhythmias detected by mobile cardiac outpatient telemetry and autotrigger looping event cardiac monitors. J Cardiovasc Electrophysiol. Dec 2017; 28(12):1475-1478.
  21. DiMarco JP, Philbrick JT. Use of ambulatory electrocardiographic (Holter) monitoring.  Ann Interm Med 1990; 113(1):53-68.
  22. Dörr, MM, Nohturfft, VV, Brasier, NN, et al. The WATCH AF Trial: SmartWATCHes for Detection of Atrial Fibrillation. JACC Clin Electrophysiol, 2019 Feb 21;5(2).
  23. Edvardsson N, Garutti C, Rieger G, et al. Unexplained syncope: implications of age and gender on patient characteristics and evaluation, the diagnostic yield of an implantable loop recorder, and the subsequent treatment. Clin Cardiol. Oct 2014; 37(10):618-625.
  24. Eisenberg EE, Carlson SK, Doshi RH, et al. Chronic ambulatory monitoring: results of a large single-center experience. J Innovations Cardiac Rhythm Manage. Nov 2014; 5:1818-1823.
  25. Ermis C, Zhu AX, Pham S, et al. Comparison of automatic and patient-activated arrhythmia recordings by implantable loop recorders in the evaluation of syncope. Am J Cardiol. Oct 1 2003; 92(7):815-819.
  26. Etgen T, Hochreiter M, Mundel M, et al. Insertable cardiac event recorder in detection of atrial fibrillation after cryptogenic stroke: an audit report. Stroke. Jul 2013; 44(7):2007-2009.
  27. Eysenck, WW, Freemantle, NN, Sulke, NN. A randomized trial evaluating the accuracy of AF detection by four external ambulatory ECG monitors compared to permanent pacemaker AF detection. J Interv Card Electrophysiol, 2019 Feb 12.
  28. Farris, GG, Smith, BB, Oates, EE, et al. New atrial fibrillation diagnosed by 30-day rhythm monitoring. Am. Heart J., 2019 Jan 15;209:29-35.
  29. Farwell DJ, Freemantle N, Sulke AN. Use of implantable loop recorders in the diagnosis and management of syncope. Eur Heart J. Jul 2004; 25(14):1257-1263.
  30. Favilla CG, Ingala E, Jara J, et al. Predictors of finding occult atrial fibrillation after cryptogenic stroke. Stroke. May 2015; 46(5):1210-1215.
  31. Fitzmaurice DA, Hobbs FD, Jowett S, et al. Screening versus routine practice in detection of atrial fibrillation in patients aged 65 or over: cluster randomised controlled trial. BMJ. Aug 25 2007; 335(7616):383.
  32. Ganesan AN, Chew DP, Hartshorne T, et al. The impact of atrial fibrillation type on the risk of thromboembolism, mortality, and bleeding: a systematic review and meta-analysis. Eur Heart J. May 21 2016; 37(20):1591-1602.
  33. Giada F, Gulizia M, Francese M, et al. Recurrent unexplained palpitations (RUP) study comparison of implantable loop recorder versus conventional diagnostic strategy. J Am Coll Cardiol. May 15 2007; 49(19):1951-1956.
  34. Gladstone DJ, Spring M, Dorian P, et al. Atrial fibrillation in patients with cryptogenic stroke. N Engl J Med. Jun 26 2014; 370(26):2467-2477.
  35. Go AS, Reynolds K, Yang J, et al. Association of Burden of Atrial Fibrillation With Risk of Ischemic Stroke in Adults With Paroxysmal Atrial Fibrillation: The KP-RHYTHM Study. JAMA Cardiol. Jul 01 2018; 3(7): 601-608.
  36. Gumbinger C, Krumsdorf U, Veltkamp R et al. Continuous monitoring versus HOLTER ECG for detection of atrial fibrillation in patients with stroke. Eur J Neurol 2012; 19(2):253-7.
  37. Halcox JPJ, Wareham K, Cardew A, et al. Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation: The REHEARSE-AF Study. Circulation. Nov 7 2017; 136(19):1784- 1794.
  38. Hanke T, Charitos EI, Stierle U et al.  Twenty-four hour Holter monitor follow-up does not provide accurate heart rhythm status after surgical atrial fibrillation ablation therapy:  up to 12 months experience with a novel permanently implantable heart rhythm monitor device.  Circulation 2009; 120; S177-S184. 
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  54. Kapa S, Epstein AE, Callans DJ, et al. Assessing arrhythmia burden after catheter ablation of atrial fibrillation using an implantable loop recorder: the ABACUS study. J Cardiovasc Electrophysiol. Aug 2013; 24(8):875-881.
  55. Kaura A, Sztriha L, Chan FK, et al. Early prolonged ambulatory cardiac monitoring in stroke (EPACS): an open-label randomised controlled trial. Eur J Med Res. Jul 26 2019; 24(1): 25.
  56. Kishore A, Vail A, Majid A, et al. Detection of atrial fibrillation after ischemic stroke or transient ischemic attack: a systematic review and meta-analysis. Stroke. Feb 2014; 45(2):520-526.
  57. Krahn AD, Klein GJ, Yee R, et al. Randomized assessment of syncope trial: conventional diagnostic testing versus a prolonged monitoring strategy. Circulation. Jul 3 2001; 104(1):46-51.
  58. Lazzaro MA, Krishnan K, Prabhakaran S. Detection of atrial fibrillation with concurrent holter monitoring and continuous cardiac telemetry following ischemic stroke and transient ischemic attack. J Stroke Cerebrovasc Dis 2012; 21(2):89-93.
  59. Leshem-Rubinow E, Berger M, Shacham J et al. New real-time loop recorder diagnosis of symptomatic arrhythmia via telemedicine.  Clin Cardiol 2011; 34(7):420-5.
  60. Locati ET, Vecchi AM, Vargiu S, et al. Role of extended external loop recorders for the diagnosis of unexplained syncope, pre-syncope, and sustained palpitations. Europace. Jun 2014; 16(6):914-922.
  61. Maines, MM, Zorzi, AA, Tomasi, GG, Angheben, CC, Catanzariti, DD, Piffer, LL, Del Greco, MM. Clinical impact, safety, and accuracy of the remotely monitored implantable loop recorder Medtronic Reveal LINQTM. Europace, 2017 Oct 11;20(6).
  62. Magnusson, PP, Olszowka, MM, Wallhagen, MM, Koyi, HH. Outcome of implantable loop recorder evaluation. Cardiol J, 2017 Aug 26;25(3).
  63. Miller DJ, Khan MA, Schultz LR, et al. Outpatient cardiac telemetry detects a high rate of atrial fibrillation in cryptogenic stroke. J Neurol Sci. Jan 15 2013; 324(1-2):57-61.
  64. Mittal S, Sanders P, Pokushalov E, et al. Safety profile of a miniaturized insertable cardiac monitor: results from two prospective trials. Pacing Clin Electrophysiol. Dec 2015; 38(12):1464-1469.
  65. Mittal S, Movsowitz C, Steinberg JS. Ambulatory external electrocardiographic monitoring: focus on atrial fibrillation. J Am Coll Cardiol 2011; 58(17):1741-9.
  66. Mullis AH, Ayoub K, Shah J, et al. Fluctuations in premature ventricular contraction burden can affect medical assessment and management. Heart Rhythm. Oct 2019; 16(10): 1570-1574.
  67. National Institute for Health and Care Excellence (NICE). Transient loss of consciousness (‘blackouts’) in over 16s. NICE guidelines 2014. Available at: www.nice.org.uk/guidance/cg109.
  68. Ng E, Stafford PJ, Ng GA.  Arrhythmia detection by patient and auto-activation in implantable loop records.  J Interv Card Electrophysiol 2004; 10(2):147-52.  
  69. Nolker G, Mayer J, Boldt LH, et al. Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study. J Cardiovasc Electrophysiol. Dec 2016; 27(12):1403-1410.
  70. Olson JA, Fouts AM, Padanilam BJ et al. Utility of mobile cardiac outpatient telemetry for the diagnosis of palpitations, presyncope, syncope, and the assessment of therapy efficacy. J Cardiovasc Electrophysiol 2007; 18(5):473-7.
  71. Page RL, Wilkinson WE, Clair WK, et al. Asymptomatic arrhythmias in patients with symptomatic paroxysmal atrial fibrillation and paroxysmal supraventricular tachycardia. Circulation. Jan 1994; 89(1):224-227.
  72. Plas GJ, Bos J, Velthuis BO, et al. Diagnostic yield of external loop recording in patients with acute ischemic stroke or TIA. J Neurol. Mar 2015; 262(3):682-688.
  73. Podoleanu C, DaCosta A, Defaye P, et al. Early use of an implantable loop recorder in syncope evaluation: a randomized study in the context of the French healthcare system (FRESH study). Arch Cardiovasc Dis. Oct 2014; 107(10):546-552.
  74. Pokushalov E, Romanov A, Corbucci G et al. Ablation of paroxysmal and persistent atrial fibrillation: 1-year follow-up through continuous subcutaneous monitoring. J Cardiovasc Electrophysiol 2011; 22(4):369-75.
  75. Prystowsky EN.  Assessment of rhythm and rate control in patients with atrial fibrillation.  J Cardiovasc Electrophysiol 2006; 17(supl 2):S7-S10.
  76. Rabinstein AA, Fugate JE, Mandrekar J, et al. Paroxysmal atrial fibrillation in cryptogenic stroke: A case-control study. J Stroke Cerebrovasc Dis. 2013 Nov; 22(8): 1405-11.
  77. Raviele A, Giada F, Bergfeldt L, et al. Management of patients with palpitations: a position paper from the European Heart Rhythm Association. Europace. Jul 2011; 13(7):920-934.
  78. Reed MJ, Grubb NR, Lang CC, et al. Diagnostic yield of an ambulatory patch monitor in patients with unexplained syncope after initial evaluation in the emergency department: the PATCH-ED study. Emerg Med J. Aug 2018; 35(8): 477-485.
  79. Reiffel JA, Schwarzbert R, Murry M.  Comparison of autotriggered memory loop recorders versus standard loop recorders versus 24-hour Holter monitors for arrhythmia detection.  Am J Cardiol 2005; 95(9):1055-9.
  80. Ritter MA, Kochhauser S, Duning T et al.  Occult atrial fibrillation in cryptogenic stroke:  detection by 7-day electrocardiogram versus implantable cardiac monitors.  Stroke 2013; 44(5):1449-52. 
  81. Rosenberg MA, Samuel M, Thosani A, et al. Use of a noninvasive continuous monitoring device in the management of atrial fibrillation: a pilot study. Pacing Clin Electrophysiol. Mar 2013; 36(3):328-333.
  82. Rothman SA, Laughlin JC, Seltzer J et al. The diagnosis of cardiac arrhythmias: a prospective multi-center randomized study comparing mobile cardiac outpatient telemetry versus standard loop event monitoring. J Cardiovasc Electrophysiol 2007; 18(3): 241-247.
  83. Saarel EV, Doratotaj S, Sterba R. Initial experience with novel mobile cardiac outpatient telemetry for children and adolescents with suspected arrhythmia. Congenit Heart Dis 2008; 3(1):33-8.
  84. Sanders P, Purerfellner H, Pokushalov E, et al. Performance of a new atrial fibrillation detection algorithm in a miniaturized insertable cardiac monitor: Results from the Reveal LINQ Usability Study. Heart Rhythm. Mar 4 2016.
  85. Sankari Z, Adeli H.  HeartSaver:  a mobile cardiac monitoring system for auto-detection of atrial fibrillation, myocardial infarction, and atrio-ventricular block.  Comput Biol Med 2011; 41(2):211-20.
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POLICY HISTORY:

Medical Policy Group, June 2009 (2)

Medical Policy Administration Committee, June 2009

Available for comment June 5-July 20, 2009

Medical Policy Group, June 2010 (2)

Medical Policy Administration Committee, June 2010

Available for comment, June 18-August 2, 2010

Medical Policy Group, December 2010; 2011 Coding update

Medical Policy Group, December 2010

Medical Policy Group, March 2011 (2)

Medical Review Committee, March 2011

Medical Policy Administration Committee, March 2011

Medical Policy Group, May 2011 (2)

Medical Review Committee, June 2011

Medical Policy Administration Committee, June 2011

Available for comment June 8 – July 25, 2011

Medical Policy Panel, October 2011

Medical Policy Group, December 2011 (2): Description and References updated

Medical Policy Group, December 2011 (3): Added 2012 ‘T’ codes effective January 1, 2012

Medical Policy Group, June 2012 (2): Policy statement updated to include coverage of auto activated external ambulatory event monitors for patients with atrial fibrillation to monitor for asymptomatic episodes to evaluated response to treatment. Updated Key Points, Key Words, References

Medical Policy Administration Committee, June 2012

Available for comment June 26 through August 9, 2012

Medical Policy Panel, November 2012

Medical Policy Group, November 2012 (2): Policy updated with literature search through October 2012. Medically necessary indication for use of event monitors in patients with atrial fibrillation treated with catheter ablation revised to be consistent with recent guidelines. Investigational indication for patients for monitoring with including but not limited to monitoring effectiveness of antiarrhythmic medications for patients with cryptogenic stroke, and detection of myocardial ischemia by detecting ST segment changes.

Medical Policy Group, December 2012 (3): 2013 Coding update – Verbiage update to Codes 93268 and 93272 effective 01/01/2013.

Medical Policy Group, December 2012 (3): 2013 Coding Update: Verbiage change to Codes 93228& 93229-added “by a physician or other qualified health care professional”. Effective 01/01/2013.

Medical Policy Administration Committee, January 2013

Available for comment January 10 through February 23, 2013

Medical Policy Panel, October 2013

Medical Policy Group, December 2013 (2): Medical criteria for coverage for implantable loop monitors revised from “…a prior trial of Holter monitor and other external ambulatory event monitors has been unsuccessful” to “…a prior trial of other external ambulatory event monitors has been unsuccessful.” Key Points and References updated with information from literature search through August 2013. Note—there is no new information in BCBSA policy 2.02.08 that will change the retired BCBSAL Holter Monitor or MCOT policies.

Medical Policy Administration Committee, January 2014

Available for comment January 9 through February 23, 2014

Medical Policy Group, March 2014 (3): Update to Description, Key Points, Key Words, Governing Bodies, & References with available equipment Verite´ by eCardio

Medical Policy Panel July 2014

Medical Policy Panel, November 2014

Medical Policy Group, January 2015 (3): 2014 Updates to Description, Key Points, Key Words, Governing Bodies & References; no change in policy statement; status remains unchanged

Medical Policy Group, January 2015 (3): 2014 Updates to Description, Key Points, Key Words & References; Policy statement updated effective February 1, 2015, to add situation of “Patients with cryptogenic stroke who have a negative standard work-up for atrial fibrillation including a 24-hour Holter monitor” to the use of patient-activated or auto-activated external ambulatory event monitors that meet medical criteria for coverage; removed patients with cryptogenic stroke from list of investigational other uses; refer also to literature updates for retired medical policies #460 and #461 – no change in policy statement on those

Available for comment February 4 through March 20, 2015

Medical Policy Panel, April 2015

Medical Policy Group, May 2015 (4): Update to policy statement to indicate that the use of an implantable monitor is medically necessary for the evaluation of cryptogenic stroke.

Available for comment May 30 through July 12, 2015

Medical Policy Panel, July 2015

Medical Policy Group, July 2015 (4): Updates to Description, Key Points, Key Words, and References. Added “and are considered investigational” to policy statement for clarification purposes. No change in policy intent.

Medical Policy Group, July 2015 (4): Updates to Key Points and References. No change to policy statement.

Medical Policy Panel, May 2016

Medical Policy Group, March 2017 (4): Incorporated MP# 460 – Mobile Cardiac Outpatient Telemetry and Hybrid Devices into this policy and MP# 460 was archived. Title updated to include MCOT and added information throughout policy pertaining to MCOT. Updates to Description, Key Points, Key Words, Approved Governing Bodies, Current Coding, References, and Policy History.  Added CPT codes 0295T-0298T, 93228 and 93229 to Current Coding section. Updated policy section by adding coverage for continuous ambulatory monitors that record and store information for periods >48 hours, updated coverage indications for implantable AEMs to include AF after an ablation, transferred MCOT policy statement to this policy which remains investigational (no change in this statement). Removed all language related to “hybrid” throughout the policy.

Medical Policy Administration Committee, April 2017

Available for comment March 18 through May 1, 2017

Medical Policy Panel, May 2017

Medical Policy Group, May 2017 (4): Updates to Description, Key Points, and References.  No change to policy statement.

Medical Policy Panel, May 2018

Medical Policy Group, May 2018 (4): Updates to Description, Policy, Key Points, and References. Added 2 IV points to the IV statement for mobile apps and monitoring asymptomatic patients with risk factors for arrhythmia. Update did not change policy intent. Removed policy statements effective for dates of service February 1, 2015 – May 31, 2015 and February 25, 2014 – January 31, 2015.

Medical Policy Administration Committee, June 2018

Medical Policy Group, December 2018:  2019 Annual Coding Update.  Added CPT codes 33285, 33286 to the Current Coding section.  Moved CPT codes 33282 , 33284 from Current Coding section to Previous coding, codes deleted 12/31/18.

Medical Policy Panel, May 2019

Medical Policy Group, June 2019 (4): Updates to Description, Key Points, and References.  No change to policy statements.

Medical Policy Panel, May 2020

Medical Policy Group, June 2020 (4): Updates to Key Points and References.  No change to policy statement.  Removed policy statements effective for dates of service on or after June 1, 2015 and prior to March 20, 2017.

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.