II-224-004

Medical Policy:

II-224-004

Topic:

Implantable Ambulatory Cardiac Event Monitors and Intracardiac Ischemia Monitoring Systems

Section:

Medicine

Effective Date:

August 2, 2021

Issued Date:

May 30, 2022

Last Revision Date:

May 2021

Annual Review:

May 2022

This policy version was replaced May 29, 2023. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).

Subcutaneously implanted ambulatory event monitors have been developed to evaluate patients with symptoms suggestive of cardiac arrhythmias. These devices are similar to external memory loop recorder devices but are typically implanted in the pectoral region of the chest and thus may be referred to as an internal loop recorder (ILR). They can be triggered by the patient (or family member witness) to store a tracing or may be automated to trigger when a rhythm suggestive of an arrhythmia is detected. Model capabilities vary. Some devices allow for transtelephonic transmission, as well as automatic detection of significant arrhythmias with remote monitoring, and more continuous rhythm monitoring via daily transmission of telemetric data.

An implantable cardiac event monitor is rarely the preferred initial test for ambulatory cardiac monitoring. However, these devices can be useful for patients with infrequent symptoms, when prior assessments with a traditional Holter monitor or external event monitor have been undiagnostic, or when assessing for atrial fibrillation following cryptogenic stroke. Examples include the Reveal LINQ™ System and the BioMonitor.

An implantable ischemia detection monitoring system, the AngelMed Guardian System™, has been approved by the FDA for use in patients who have had prior acute coronary syndrome (ACS) events and who remain at high risk for recurrent ACS events. The system is to be used in an ambulatory setting as an adjunct to patient recognized symptoms to detect potential ongoing ACS events characterized by sustained ST segment changes.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

I. Implantable Ambulatory Event Monitors

Implantable ambulatory event monitors may be considered MEDICALLY NECESSARY AND APPROPRIATE when ALL of the following criteria are met:
- ONE of the following;
  - Unexplained symptoms suggestive of cardiac arrhythmias (i.e., palpitations, syncope or pre-syncope), and the symptoms occur less frequently than every 2 weeks; or
  - History of cryptogenic stroke with suspected occult atrial fibrillation as the cause of the stroke; or
  - Following cardiac ablation to monitor arrhythmia status when changes in medical management are being considered;
- AND
- Previous non-diagnostic trial of external ambulatory event monitoring (e.g., Zio® Patch, external memory loop device) of at least 14 days continuously during the past 90 days; AND
- Ordered by a cardiologist, electrophysiologist or neurologist or advanced practice provider (e.g., physician’s assistant, nurse practitioner) supervised by, or in consultation with, a physician in one of these specialties.
The use of implantable ambulatory event monitors is considered EXPERIMENTAL/ INVESTIGATIVE for all other indications due to a lack of clinical evidence demonstrating an impact on improved health outcomes.

II. Implantable Intracardiac Ischemia Monitoring Systems

The use of implantable intracardiac ischemia monitoring systems is considered EXPERIMENTAL/ INVESTIGATIVE for all indications due to a lack of clinical evidence demonstrating an impact on improved health outcomes.

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Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.

Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement.

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