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POLICY AND PROCEDURE MANUAL
Policy Title: Loop Recorders
Policy Number: A.08
Primary Department: Medical Management
Affiliated Department(s): N/A
NCQA Standard: N/A
URAC Standard: N/A
Last Revision Date: 07/17/2015
Next Review Date: 09/2016
Revision Dates: 07/17/2015
Review Dates: 09/25/2015
Effective Date: 10/20/2015
Special Instructions Alert: N/A
State/Program
Medicare:
Medicaid:
Commercial:
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Policy: Meridian Health Plan (MHP) considers the use of implantable loop recorder cardiac event monitors
(i.e., FDA approved Reveal Insertable Loop Recorders, including Reveal XT, DX and LINQ) medically
necessary only in a limited role, in a very small subset of patients, who experience at least two episodes of
recurrent, infrequent*, unexplained symptoms of pre-syncope, syncope, or tachycardia with severe symptoms of
hemodynamic instability, when both of the following criteria are met:
1. A cardiac arrhythmia is suspected as the cause of the symptoms; and
2. A prior trial of Holter Monitor and other external ambulatory event monitors have been unsuccessful in
determining a definitive diagnosis, or a diagnostic ECG.
*An infrequent but recurrent symptom of pre-syncope, syncope, or tachycardia with severe symptoms of
hemodynamic instability would be indicative of frequency of at least two episodes within six months.
MHP considers the use of implantable loop recorder cardiac event monitors (i.e., FDA approved Reveal
Insertable Loop Recorders, including Reveal XT, DX and LINQ) for detection of atrial fibrillation following
cryptogenic stroke investigational. Peer review literature is limited and although the prevention of recurrent
strokes in patients with cryptogenic stroke is feasible through enhanced detection provided by ICM, additional
randomized trials are needed to assess whether the information yielded by ILR monitoring improves clinical
management and influences the rate of secondary stroke and overall morbidity and mortality in patients who
have experienced a cryptogenic stroke. In addition, the patient population most likely to benefit from
monitoring needs to be better defined.
Primary Department
Policy: #.##
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Procedure: Per the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial
Fibrillation:Executive Summary, “ Atrial fibrillation (AF) may be described by the duration of the episode.
Implanted loop recorders, pacemakers, and defibrillators offer the possibility of reporting frequency, rate, and
duration of abnormal atrial rhythms, including atrial fibrillation (AF). Episodes often increase in frequency and
duration over time.
Per the FDA: The Reveal LINQ Insertable Cardiac Monitor is an implantable patient-activated and
automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following
cases:
 Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias;
 Patients who experience transient symptoms such as dizziness, palpitation, syncope and chest pain that
may suggest a cardiac arrhythmia;
 The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient
Assistant activates the data management features in the Reveal LINQ ICM to initiate recording of
cardiac event data in the implanted device memory.
The Centers for Medicare & Medicaid Services (CMS) has a national coverage determination for
electrocardiographic (EKG) services (20.15), publication number 100-3, which states that an implantable or
insertable loop recorder (ILR) is another type of pre-symptom memory loop recorder (MLR), that is implanted
subcutaneously in a patient’s upper left chest and may remain implanted for many months. An ILR is used
when syncope is thought to be cardiac-related, but is too infrequent to be detected by either a Holter Monitor or
a traditional pre-symptom MLR.
1. Certain cardiac event monitors capture electrical activity with a single electrode attached to the skin.
Other devices may employ multiple electrodes in order to record more complex EKG tracings.
Additionally, devices may be individually programmed to detect patient-specific factors, electrode
malfunction, or other factors. Cardiac event monitors can be further categorized as either “pre-event” or
“post-event” recorders, based on their memory capabilities:
a. Pre-symptom Memory Loop Recorder (MLR): Upon detecting symptoms, the wearer presses a
button, which activates the Recorder to save (i.e., memorize) an interval of pre-symptom EKG
data along with data during and subsequent to the symptomatic event. Self-sensing Recorders
(also known as event-activated or automatic trigger) do not require patient input to capture these
data. Single or multiple events may be recorded. The device is worn at all times, usually for up
to 30 days.
b. Implantable (or Insertable Loop) Recorder (ILR): Another type of pre-symptom MLR, it is
implanted subcutaneously in a patient’s upper left chest and may remain implanted for many
months. An ILR is used when syncope is thought to be cardiac-related, but is too infrequent to
be detected by either a Holter™ monitor or a traditional pre-symptom MLR.
c. Post-symptom Recorder: The patient temporarily places this device against the chest when
symptoms occur and activates it by pressing a button. These Recorders represent old
technology, as they do not include a memory Loop. The device transmits EKG data
telephonically in real-time and is usually used for up to 30 days.
Special Instructions: N/A
CPT/HCPCS Codes:
33282, 33284, 93224, 93225, 93225, 93227, 93228, 93229, 93268, 93270, 93271, 93272, 93285, 93291, 93298, C1764, E0616
Primary Department
Policy: #.##
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Approved by: __________________________________
Corporate Chief Operating Officer
Reviewed and approved by Policy and Procedure Committee:
Reviewed and approved by Medical Policy Operations Committee:
Reviewed and approved by Physician Advisory Committee:
Reviewed and approved by Corporate Compliance Committee:
Date: 10/20/2015
Date: 07/17/2015
Date: 07/31/2015
Date: 09/25/2015
Date: 10/20/2015
References:
1. Centers for Medicare and Medicaid Services. National Coverage Determination (NCD) for Electrocardiographic
Services (20.15). Version number 2, effective Date: 08/26/2004.
2. Centers for Medicare and Medicaid Services, Decision Memo for Electrocardiographic Services (CAD-00158N).
Retrieved from: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=89&
ver=6&NCDId=179&ncdver=2&NcaName=Electrocardiographic+Services&IsPopup=y&bc=AAAAAAAAEAAA&
3. Calkins H, Brugada J, Packer DL, et al. European Heart Rhythm Association (EHRA); European Cardiac Arrhythmia
Society (ECAS); American College of Cardiology (ACC); American Heart Association (AHA); Society of Thoracic
Surgeons (STS). HRS/EHRA/ECAS expert Consensus Statement on catheter and surgical ablation of atrial fibrillation:
recommendations for personnel, policy, procedures and follow-up. A report of the Heart Rhythm Society (HRS) Task
Force on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2007;4 (6):816-861. Available at:
http://www.or-live.com/hrs/2216/HR-and-Euro-AF-Consensus-Stmt.pdf.
4. Zipes DP, Camm AJ, Borggrefe M, et al. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular
arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American
Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing
Committee to develop guidelines for management of patients with ventricular arrhythmias and the prevention of sudden
cardiac death). Circ. 2006; 114:1088-1132. Available at: http://circ.ahajournals.org/cgi/reprint/114/10/e385.
5. Cardiac arrhythmias. Washington (DC): American College of Cardiology (ACC); 2007
6. Roger VL, Go AS, Lloyd-Jones DM, et al.; American Heart Association Statistics Committee and Stroke Statistics
Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association
[correction appears in Circulation. 2012;125(22):e1002]. Circulation. 2012;125(1):e2-e220. Available at:
http://circ.ahajournals.org/content/125/1/e2.long.
7. Hayes Search and Summary. Implantable Cardiac Loop Recorders for Syncope. March 2015
8. U.S. FDA. 510K Summary. Reveal LINQ Insertable Cardiac Monitor. K132649. February 14, 2014. Available at:
http://www.accessdata.fda.gov/cdrh_docs/pdf13/k132649.pdf
9. January CT, Wann LS, Alpert JS, et al.; ACC/AHA Task Force Members. 2014 AHA/ACC/HRS Guideline for the
Management of Patients With Atrial Fibrillation: Executive Summary: A Report of the American College of
Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. Circulation.
2014;130(23):2071-2104. Available at: http://circ.ahajournals.org/content/early/2014/04/10/CIR.0000000000000040.long
State Letters/Bulletins
CMS National/Local Coverage Determination (NCD/LCD)
Medicare Managed Care Manual:
NCD. 20.15
Medicaid CFR:
State Administrative Codes:
Contract Requirements:
Related Policies:
Primary Department
Policy: #.##
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