Holter Monitor:
An external monitor with electrodes attached to the skin that measures activity continuously for up to 48 hours. (Holter Monitors are not addressed in this policy.)

Ambulatory Cardiac Monitors:
Monitors activated only when triggered by the individual:

• These monitors are often referred to as event monitors. The two (2) basic types are:
  • Looping memory monitor: activated by pushing a button; stores data from before and during symptom occurrence, prior to when it was activated; if activated immediately after a syncopal episode, it will record from the time before the event;
  • Symptom event monitor: activated by pushing a button; does not store data prior to when it was activated.

ZIO Patch:
An external monitor applied by adhesive to the chest; it records continuously and typically is worn up to  14 days. It is much less expensive than the mobile cardiac output telemetry and the implantable monitors.

Mobile Cardiac Outpatient Telemetry (MCOT):
A type of loop monitor that is auto-triggered by rhythm changes and also can be triggered by the individual.  It is commonly ordered for 14 or 30 day periods. 

Implantable Cardiac Monitor:
A monitor implanted under the skin that can monitor continuously and can be triggered by the individual; it may be implanted for several years.

Ambulatory Cardiac Monitors

The use of individual -activated or auto activated external ambulatory event monitors or continuous ambulatory monitors that record and store information for periods greater than 48 hours may be considered medically necessary as a diagnostic alternative to Holter monitoring.

Quantity Level Limits (QLL)

• Ambulatory event monitors may be considered medically necessary once in a 30 day period regardless of the number of events or recordings which occurred. Ambulatory event monitors are considered part of the global allowance and are not eligible for separate reimbursement when performed more frequently within the 30 day period.
• Ambulatory event monitors for greater than 30 consecutive days in a twelve (12) month period must be referred for a medical necessity determination. An additional 30 consecutive days may be considered medically necessary in EITHER of the following situations:
  • After treatment has been initiated, the symptoms continue to occur; or
  • No symptoms occurred during the initial 30 day use of the recorder.

Additional use greater than 30 consecutive days can be made only if documentation (e.g., office notes) can establish the medical need for the frequency.

Ambulatory Cardiac Monitoring (ZIO Patch) and Event Monitors

The use of long-term (greater than 48 hours) external ECG monitoring by continuous rhythm recording and storage (e.g., Zio Patch) may be considered medically necessary for EITHER one of the following:

• Individuals who experience infrequent symptoms (less frequently than every 48 hours) suggestive of cardiac arrhythmias (i.e., palpitations, dizziness, presyncope, or syncope); or
• Individuals with atrial fibrillation (AF) who have been treated with catheter ablation and in whom discontinuation of systemic anticoagulation is being considered.

All other indications are considered not medically necessary.

Mobile Cardiac Outpatient Telemetry (MCOT)  

MCOT is limited to a select population and may be considered medically necessary when ALL of the following are met:

• The individual has failed  the following:
  • 48 hour Holter monitor AND/OR it is felt that longer monitoring is necessary; and
  • ZIO patch; or
  • Individual-triggered event monitor;  or
• The individual’s condition is such that a Holter monitor OR an event monitor OR a Zio Patch is NOT adequate to make a diagnosis.  An explanation must be provided as to why ONLY the MCOT would be sufficient; and
• There is low likelihood of a malignant cardiac event; and
• Individuals who experience infrequent symptoms (less than every 24-48 hours) suggestive of cardiac arrhythmias (i.e., palpitations, dizziness, pre-syncope, or syncope); and
• It is anticipated that the results of this service would provide diagnostic and treatment information; and

ANY of the following:

• Individuals who require monitoring for known, non-life-threatening arrhythmias, such as AF, other supra-ventricular arrhythmias, evaluation of various bradyarrhythmias and intermittent bundle branch block; or
• Individuals recovering from cardiac surgery who have documented atrial arrhythmias; or
• Individuals with symptomatic underlying structural disease; or
• Individuals with no structural heart disease but have recurrent severe symptoms (i.e., recurrent syncope), all testing is negative and an implantable event recorder is contemplated; or
• Individuals with unexplained syncope, near syncope, or episodic dizziness; or
• Individuals with unexplained recurrent palpitations; or
• Individuals with unexplained recurrent shortness of breath; or
• Individuals with unexplained recurrent chest pain; or
• Individuals with a history of acute myocardial infarction (MI); or
• Individuals who require evaluation of antiarrhythmic drug therapy.

Contraindications

• Real-time outpatient cardiac monitoring is contraindicated for individuals at high risk of developing sustained ventricular tachycardia or ventricular fibrillation and/or would be more appropriately cared for in a hospital setting.
• The MCOT is not indicated for individuals with mild to moderate symptoms of "palpitations" or "weakness."
• This system is also not indicated for use as a screening tool.

Use of cardiac surveillance and Holter or event monitoring for the same individual on the same day is considered not medically necessary.

All other indications are considered not medically necessary.

QLL 

• MCOT is considered not medically necessary when more than one (1) monitoring episode is reported in a 30 day period.
• MCOT is considered not medically necessary when more than two (2) monitoring episodes are reported in a (12) month period.

Implantable Cardiac Loop Recorder

The implantation and removal of a cardiac loop recorder may be considered medically necessary when an individual meets the following:

• 48 hour Holter monitor AND/OR it is felt longer monitoring is necessary; and
• A ZIO patch; or
• An individual-triggered event monitor; or
• The individual’s condition is such that those devices are not adequate to make a diagnosis AND there is documentation of the following:
  • Palpitations; or
  • Dizziness; or
  • Syncope and collapse; or
  • Other transient symptoms which could be due to arrhythmia; or
  • Long term cardiac monitoring post cryptogenic stroke or transient ischemic attack (TIA) (See criteria for “Long Term Cardiac Monitoring Post Cryptogenic Stroke or TIA”;  and
  • When BOTH of the following criteria are met:
    • A cardiac arrhythmia is suspected as the cause of the symptoms; and
    • EITHER of the following criteria are met:  
      • Individuals with heart failure, prior MI or significant ECG abnormalities, noninvasive ambulatory monitoring, consisting of 30-day presymptom external loop recordings or MCOT, fails to establish a definitive diagnosis; or
      • Individuals without heart failure, prior MI or significant ECG abnormalities, symptoms occur so infrequently and unpredictably (less than one (1) per month) that noninvasive ambulatory monitoring (MCOT or external loop recorders) are unlikely to capture a diagnostic ECG.

All other indications are considered not medically necessary.

QLL     

A remote interrogation device evaluation may be considered medically necessary once in 30 days with interim physician analysis and review.  A remote interrogation device evaluation greater than 30 days are considered part of the global allowance and are not eligible for separate reimbursement.

Implantable Cardiac Loop Recorder for Post Cryptogenic Stroke or TIA

An implantable cardiac loop recorder, for post cryptogenic stroke or TIA, may be considered medically necessary when ALL of the following are met:

• Diagnosis of a cryptogenic ischemic stroke or TIA should be based upon evaluation by a neurologist; and
• The following standard tests are ALL required to establish diagnosis of cryptogenic stroke:  
  • Brain MRI or CT; and
  • 12 lead ECG for AF detection; and
  • 24 hour ECG monitoring for AF detection (e.g. Holter); and
  • Transesophageal echocardiography (TEE); and
  • CT angiography (head and neck) or magnetic resonance angiography (MRA) (head and neck) to rule out other causes of stroke; and
• The individual is greater than or equal to 40 years of age; and
• A documented collaborative treatment plan between neurologist and cardiologist; and
• A TIA requires additional documentation of speech disturbance or limb weakness.

Not Medically Necessary

Implantable cardiac loop recorders post cryptogenic stroke or TIA are considered not medically necessary if a patient has ANY of the following:

• The individual has a known etiology of stroke or TIA (i.e., large artery atherosclerosis, acute small artery occlusion with a lesion less than one (1) cm in diameter by CT or MRI; or
• Evidence of high-risk cardiac or aortic arch source of embolism (left ventricular (LV) or left atrial (LA) thrombus) or ”smoke”, emboligenic valvular lesion or tumor, patent foramen ovale (PFO) with extant source of venous thromboembolism, aortic arch plaque greater than three (3) mm thick or with mobile components; or
• History of spontaneous deep vein thrombosis (DVT); or
• Stroke of other determined cause such as the presence of non-atherosclerotic vasculopathy, hypercoagulable states (must be tested in individuals less than 55 years of age) and hematologic disorders; or
• Untreated hyperthyroidism; or
• MI less than one (1) month before stroke/TIA; or
• Coronary bypass grafting (CABG) less than one (1) month before stroke/TIA; or
• Valvular disease requiring immediate surgical intervention; or
• Documented history of AF or atrial flutter; or
• Presence of PFO and PFO is an indication to start oral anticoagulant therapy in accordance with European Stroke Organization (ESO) guidelines; or
• The individual has a permanent indication for anticoagulation; or
• The individual  has a permanent contraindication for anticoagulation; or 
• Life expectancy less than one (1) year; or
• The individual is indicated for implant with pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT) or implantable hemodynamic monitoring system.

All other indications are considered not medically necessary.