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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 11/01/2011 Title: Cardiac Event Recorder, Insertable Loop Recorder
Revision Date: 01/01/2019 Document: BI318:00
CPT Code(s): 33282, 33285, E0616
Public Statement
Effective Date: a) This policy will apply to all services performed on or after the above revision date which will become the new effective date. b) For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply. The insertable cardiac event recorder is implanted subcutaneously in a single incision procedure in a left pectoral or mammary location. Its projected longevity is 14 months to a low battery condition. It is used in patients with syncope who have infrequent episodes that have defied diagnosis by standard methods, and is covered in such individuals. This device requires prior authorization.
Medical Statement

1)    An insertable loop recorder will be covered:

a)    Only if a definitive diagnosis for syncope (R55) has not been made after ALL of the following conditions have been met:

i.      Complete history and physical examination;

ii.    Electrocardiogram (ECG);

iii.   Two (2) negative or non-diagnostic 30-day pre-symptom memory loop patient demand recordings (may be either single or multiple event recordings);

iv.   Negative or non-diagnostic tilt table testing.  

2)    Any other use of this device is considered not medically necessary and will not be covered.

3)    The ILR device insertion procedure is considered to be a physician service. It carries a 90 day global and does not require an assistant surgeon. Removal of an ILR device on the same day as the insertion of a cardiac pacemaker in any given patient is considered to be a part of the pacemaker insertion procedure and will not be covered separately.

Codes Used In This BI:

33282     Implantation of patient-activated cardiac event recorder (code deleted 1/1/19)

33285     Insertion, subcut cardiac rhythm monitor, incl programming (new code 1/1/19)

E0616    Implantable cardiac event recorder w/memory, activator, and programmer

Limits

Use of ILR in the following conditions:

    • Patients with presyncopal episodes;
    • Patients failing to fulfill the indications for coverage of this policy;
    • Patients for whom compliance or lifestyle makes use of external monitoring systems inconvenient.
    • Patients receiving another ILR device within the last two years

is not covered as being not medically necessary.


Background

510(k) approval (substantially equivalent device) was granted for the Medtronic Reveal ILR on January 16, 1998 for use as “an implantable patient-activated monitoring system that records subcutaneous ECG and is indicated for patients who experience transient symptoms that may suggest a cardiac arrhythmia.”

 

The Reveal ILR is a device 61 mm x 19 mm x 8 mm weighing 17 grams. It is implanted subcutaneously in a single incision procedure in a left pectoral or mammary location.  Its projected longevity is 14 months to a low battery condition.  The manufacturer recommends that the device be explanted when it is no longer clinically necessary or when the battery is depleted.


Reference

1.     ECRI Evidence-based Practice Center (2007) Remote cardiac monitoring 12-12-2007. Agency for Healthcare Research & Quality. http://www.cms.hhs.gov/mcd/viewtechassess.asp?where=index&tid=51, accessed 1-14-08.

2.     Krahn AD, Klein GJ, Norris C, et al. (1995) The etiology of syncope in patients with negative tilt table and electrophysiological testing. Circa 1995; 92:1819-182.

3.      Krahn AD, Klein GJ, Yee R. (1997) Recurrent Syncope. Experience with an implantable loop recorder. Card Clin 1997; 2:313-326.

4.     Strickberger SA, Benson DW, et al. (2006) AHA/ACCF scientific statement on the evaluation of syncope. J Am Coll Cardiol, 2006; 47:473-84.


Application to Products

This policy applies to all health plans and products administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) or Certificate of Coverage (COC) for those plans or products insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD, EOC, or COC, as applicable, will prevail.  State and federal mandates will be followed as they apply.

 


Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
This policy has recently been updated. Please use the index above or enter policy title in search bar for the latest version.