Clinical UM Guideline
|Guideline #:||CG-MED-44||Current Effective Date:||10/14/2014|
|Status:||Reviewed||Last Review Date:||08/14/2014|
This document addresses the use of the standard external ambulatory Holter monitor. Holter monitors are ambulatory, noninvasive, unattended electrocardiography (ECG) devices that provide continuous recordings of the heart for a minimum of 24 or 48 hours. Ambulatory ECG (AECG) devices may be used as a diagnostic tool for individuals with specified symptoms and/or to assess response to specified therapies. This document does not address attended, real time ECG monitoring and ambulatory event monitors.
Note: For see the following related documents for additional information:
Continuous 24- to 48- hour ambulatory ECG Holter monitor use is considered medically necessary for adults with any of the following indications:
Continuous 24- to 48- hour ambulatory ECG Holter monitor use is considered medically necessary for children with any of the following indications:
Not Medically Necessary:
Ambulatory ECG Holter monitor use is considered not medically necessary when the above criteria are not met.
Ambulatory ECG Holter monitor use is considered not medically necessary for all other indications including, but not limited to:
The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
|93224||External electrocardiographic recording up to 48 hours by continuous rhythm recording and storage; includes recording, scanning analysis with report, review and interpretation by a physician or other qualified health care professional|
|93225||External electrocardiographic recording up to 48 hours by continuous rhythm recording and storage; recording (includes connection, recording and disconnection)|
|93226||External electrocardiographic recording up to 48 hours by continuous rhythm recording and storage; scanning analysis with report|
|93227||External electrocardiographic recording up to 48 hours by continuous rhythm recording and storage; review and interpretation by a physician or other qualified health care professional|
|ICD-9 Diagnosis||[For dates of service prior to 10/01/2015]|
|411.0-411.89||Other acute and subacute forms of ischemic heart disease|
|425.4||Other primary cardiomyopathies|
|429.9||Heart disease, unspecified|
|746.84||Obstructive anomalies of heart, NEC|
|746.86||Congenital heart block|
|746.89||Other specified anomalies of heart|
|780.2||Syncope and collapse|
|780.4||Dizziness and giddiness|
|786.50||Chest pain, unspecified|
|V45.01-V45.02||Cardiac device in situ; cardiac pacemaker, automatic implantable cardiac defibrillator|
|V53.31-V53.32||Fitting and adjustment of cardiac pacemaker, automatic implantable cardiac defibrillator|
|ICD-10 Diagnosis||[For dates of service on or after 10/01/2015]|
|I20.1||Angina pectoris with documented spasm|
|I20.9||Angina pectoris, unspecified [chest pain]|
|I24.0-I24.9||Other acute ischemic heart diseases|
|I42.1||Obstructive hypertrophic cardiomyopathy|
|I42.2||Other hypertrophic cardiomyopathy|
|I44.0-I45.9||Atrioventricular and left bundle-branch block, other conduction disorders|
|I47.0-I49.9||Paroxysmal tachycardia, atrial fibrillation and flutter, other cardiac arrhythmias|
|Q24.6||Congential heart block|
|Q24.8||Other specified congenital malformations of heart|
|R00.0-R00.9||Abnormalities of heart beat|
|R42||Dizziness and giddiness|
|R55||Syncope and collapse|
|Z45.010-Z45.018||Encounter for adjustment and management of cardiac pacemaker|
|Z45.02||Encounter for adjustment and management of automatic implantable cardiac defibrillator|
|Z95.0||Presence of cardiac pacemaker|
|Z95.810||Presence of automatic (implantable) cardiac defibrillator|
Holter monitors are self-contained recording devices that provide a graphic representation of electrical activity within the heart. Electrodes are placed externally in predetermined locations on an individual's chest to detect and record the electrical activity of the heart. Individuals maintain a diary of activities and symptoms while wearing the Holter monitor. The information from the Holter ECG is reviewed and interpreted by a physician to determine a diagnosis and a treatment plan.
AECG utilizing the traditional Holter monitoring devices has been in use for many years to diagnose a wide range of heart disease and other conditions that manifest themselves by abnormal cardiac electrical activity (Centers for Medicare & Medicaid Services, 2004). Holter monitors have a low sensitivity for detecting intermittent arrhythmias. Therefore, Holter monitors are utilized to evaluate frequently occurring symptoms (for example, daily or multiple occurrences during the day) and ECG events.
The practice of AECG using a Holter monitor over 24-48 hours has been based on clinical practice guidelines reviewed and published by the American College of Cardiology (ACC), American Heart Association (AHA) and the European Society of Cardiology (ESC).
The ACC/AHA Task Force on Practice Guidelines, in collaboration with the North American Society for Pacing and Electrophysiology, provided guidelines and recommendations for AECG (Crawford, 1999). The Class I – IIa recommendations included the common and accepted use of AECG Holter monitoring to determine the relationship of transient, unexplainable symptoms that may be suggestive of cardiac arrhythmias (for example, palpitations, dizziness or syncope), as well as unexplained, recurrent palpitations. For individuals with idiopathic hypertrophic cardiomyopathy, AECG is indicated to detect arrhythmias and to assess risk for future cardiac events. Holter AECG monitoring can assess response to antiarrhythmic drugs, as well as detect proarrhythmic responses to antiarrhythmic therapy in high-risk individuals. AECG has also been recommended to evaluate and assess ICDs and pacemakers, including the response to adjunctive pharmacological therapy. The guidelines included recommendations for AECG Holter monitoring in the pediatric population.
Recommendations from the ACC/AHA Task Force guidelines that were based on lower levels of evidence included Holter monitor use to measure heart rate variability as a risk assessment for future cardiac events in individuals who had ventricular dysfunction after a myocardial infarction (class II, level of evidence B) and as an evaluation for diabetic neuropathy in individuals with diabetes (class III level of evidence) (Crawford, 1999).
Ole and colleagues (2012) investigated if cardiovascular autonomic neuropathy (CAN) could be detected by simple function tests compared to heart rate variability (HRV) from 24-hour AECG recordings in individuals with type 1 and type 2 diabetes. Randomly selected individuals with diabetes were monitored for 24 hours with a Holter monitor. The participants were then put through a series of five function tests to assess the autonomic nervous system. The trained technician who edited the 24-hour AECG recordings was blinded to the participants' information. Data from participants with acceptable 24-hour AECG recordings and had completed all five function tests were analyzed. The investigators assessed all of the variables and determined that the Valsalva ratio (p=0.002), the 30:15 ratio (p=0.037), and the handgrip (p=0.037) function tests were significant predictors for all-cause mortality and CAN, as compared to 24-hour AECG Holter monitor recordings.
In 2011, the ACCF/AHA Foundation published Guidelines for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy (HCM) that included recommendations for AECG Holter monitoring. Twenty-four–hour AECG Holter monitoring was recommended in the initial evaluation of individuals with HCM to detect ventricular tachycardia (VT) and to identify candidates for ICD therapy and in individuals with HCM who developed palpitations or lightheadedness (Gersh, 2011).
In the 2006 (Zipes) report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology (ACC/AHA/ESC) Committee for Practice Guidelines, continuous 24- and 48-hour AECG Holter recording was deemed, "Appropriate whenever the arrhythmia is known or suspected to occur at least once a day." Conventional standard external and implantable ambulatory event monitors were considered more appropriate for sporadic episodes of palpitations, dizziness or syncope. The need to clarify the diagnosis by detecting arrhythmias, such as QT-interval changes or ST changes, to evaluate cardiac risk for arrhythmic events or to assess the therapeutic response to anti-arrhythmic medications was a class I recommendation (level of evidence A) for AECG with Holter monitoring.
The 2012 Heart Rhythm Society/ European Heart Rhythm Association/ European Cardiac Arrhythmia Society Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation (Calkins, 2012) notes there are early recurrences of atrial fibrillation during the first one to three months following a catheter ablation procedure for treatment of atrial fibrillation. Therefore, a three month blanking period after ablation therapy is typically used when reporting efficacy outcomes. Asymptomatic atrial fibrillation commonly occurs after ablation therapy and Holter monitoring is useful in detecting the asymptomatic episodes and determining efficacy of the ablative therapy.
In 2010, Hoefman published a systematic review on diagnostic tools for detecting cardiac arrhythmias. This analysis included studies of subjects presenting with palpitations and compared the yield of remote monitoring for several classes of devices: Holter monitors; patient-activated event recorders; auto-triggered event recorders; and implantable loop recorders. The yield varied among devices, with the autotrigger devices offering the highest range of detection (72-80%), followed by the patient-activated devices (17-75%), and Holter monitors (33-35%). No combined analysis was performed due to the heterogeneity of the study population and study design. Limitations in the evidence base precluded any specific recommendations on the selection of devices. The authors concluded that the choice of device should be driven largely by the presence, type, and frequency of symptoms experienced by each individual.
The ACC/AHA practice guidelines and published peer reviewed literature support the clinical utility of standard Holter AECG monitors in the specified clinical indications.
There are multiple cardiovascular monitoring devices (Holter monitors) that have received U.S. Food & Drug Administration 510(k) clearances as Class II devices. Some newer devices are continuous monitors that are similar to traditional AECG Holter monitoring in concept, but offer other features such as the ability to monitor for longer periods of time. However, there is a lack of published, peer-reviewed evidence to support the clinical utility of long-term (greater than 48 hours), continuous, external, unattended cardiac monitoring with a Holter monitor.
Arrhythmia: Abnormal heart rhythms which may be classified as either atrial or ventricular, depending on the origin in the heart. Individuals with arrhythmias may experience a wide variety of symptoms ranging from palpitations to fainting.
Atrial fibrillation: A quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications.
Myopotential: The electric signal originating from skeletal muscle (usually the pectoralis major), close to a pacemaker, which may be sensed by the pacemaker during activity and falsely interpreted as a depolarization.
Physiological pacing: A dual chamber or atrium-based pacing device used to maintain atrioventricular synchrony.
Rate-responsive pacing: A pacemaker that can vary the pacing rate, depending on the immediate needs of the individual using sensors of body motion or respiratory rate.
Syncope: An episode where the individual experiences loss of consciousness lasting at least several seconds. If extreme dizziness is experienced without actual loss of consciousness, this is termed "pre- syncope."
Tachycardia: An abnormally rapid heartbeat.
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
|Websites for Additional Information|
Continuous cardiac recorder
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
|Reviewed||08/14/2014||Medical Policy & Technology Assessment Committee (MPTAC) review. Updated References and Websites sections.|
|Revised||08/08/2013||MPTAC review. Added medically necessary indication as a method to assess for asymptomatic atrial fibrillation three or more months after ablation of arrhythmogenic foci for atrial fibrillation. Updated Discussion/General Information, Definitions, References and Websites sections.|
|New||05/09/2013||MPTAC review. Initial document development.|