ModifiedColorado Rocky Mountain Health PlansPolicy N/A

Implantable Loop Recorders and Ambulatory Cardiac Monitoring

This policy governs medical necessity coverage and clinical guidance for implantable loop recorders (ILRs), ambulatory ECG monitoring modalities, and wearable/self-monitoring cardiac devices, including age-specific criteria and exclusions; it also documents coding changes and supporting evidence references. This is Part 2 of 2 (clinical evidence, guidelines, and revision history).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyImplantable Loop Recorders and Ambulatory Cardiac Monitoring

Policy CodePolicy N/A

Change TypeTitle change; added pediatric indications; removed CPT codes; wearable devices deemed not medically necessary

Effective DateJune 1, 2025

Next Review DateJun 1, 2025

Key ActionProviders must document that noninvasive cardiac event recording was contraindicated or yielded non-diagnostic results after at least two weeks of monitoring and that one or more qualifying indications are present; for replacements, document continued fulfillment of initial criteria and device end-of-life or malfunction.

POLICY UPDATE CHANGES

Policy title changed from 'Cardiac Event Monitoring (for Ohio Only)' to emphasize Implantable Loop Recorders.

Added pediatric (Members Under 18 Years of Age) ILR indications including cryptogenic stroke AF, ventricular arrhythmia, high-risk structural/infiltrative heart disease, recurrent unexplained infrequent syncope, and abnormal tests.

Removed numerous CPT codes from the applicable codes section (list provided).

Updated supporting information sections: Clinical Evidence and References to reflect current information.

5Pediatric ILR Indications Listed

1Policy Title Changed

Coverage Summary

This policy (Part 2 of 2) governs medical necessity coverage and clinical guidance for Implantable Loop Recorders (ILRs), ambulatory ECG monitoring modalities, and wearable/self-monitoring cardiac devices. It specifies that Implantable Loop Recorders are proven and medically necessary in certain circumstances when noninvasive monitoring is contraindicated or non-diagnostic after at least two weeks of monitoring, and it defines age-specific pediatric ILR indications. The policy explicitly excludes wearable consumer-grade cardiac self-monitoring devices (e.g., ECG-enabled watches or phone-linked monitors) as not medically necessary.

Policy title was revised from 'Cardiac Event Monitoring (for Ohio Only)' to emphasize Implantable Loop Recorders; replacement ILRs are addressed when initial criteria continue to be met and the device is beyond useful life or nonfunctional. Effective/Last review date: 2025-06-01 (last_review). This document is Part 2 of 2 per the scope summary (clinical evidence, guidelines, and revision history).

Surface threshold and quick facts

Noninvasive monitoring duration before ILRAt least two weeks of monitoring

Pediatric ILR indications listed5

CPT codes removed19

Policy title changed1

Evidence highlight - Post-stroke AF detection (ESC RCTs)Approximately 23.7% AF detection after stroke per ESC guideline review

Medical-Necessity Criteria

Members Under 18 Years of Age - Indications for ILR

Implantable Loop Recorders are proven and medically necessary when noninvasive cardiac event recording is contraindicated or yielded non-diagnostic results after at least two weeks of monitoring and ONE or more of the following are present:

ANY of the following

Suspected paroxysmal atrial fibrillation in the setting of a cryptogenic stroke or another documented systemic thromboembolic event
Suspected or known ventricular arrhythmia
High risk for arrhythmia secondary to structural or infiltrative heart disease such as aortic stenosis, hypertrophic cardiomyopathy, cardiac sarcoidosis, congenital heart disease, family history, dilated ischemic or nonischemic cardiomyopathy, or use of medications known to cause malignant arrhythmias such as those prolonging the QT interval

Coding

Removed CPT codes (no longer applicable)CPT

93224
93225
93226
93227
93228
93229
93241
93242
93243
93244

1–10 of 18

1/2

Provider Actions & Billing Impact

Prior Authorization

Medical necessity documentation for ILR insertion/replacement

Document that noninvasive cardiac event recording was contraindicated or yielded non-diagnostic results after at least two weeks of monitoring (threshold: at least two weeks) or that monitoring was not feasible. Also document that ONE or more qualifying indications from policy are present (e.g., suspected paroxysmal AF after cryptogenic stroke, suspected/known ventricular arrhythmia, high arrhythmia risk from structural/infiltrative disease, recurrent unexplained infrequent syncope after medication modification, or abnormal tests such as EP study or tilt table). For replacements, document continued fulfillment of the initial insertion criteria and that the existing device is beyond its useful life span, irreparable, or no longer operating (device end-of-life or malfunction).

Noninvasive monitoring duration threshold: at least two weeks
Replacement requires continued criteria plus device beyond useful life or nonfunctional

Background and Supporting Evidence

Background: This part of the policy summarizes guideline recommendations from multiple professional societies including AHA/ASA, CCS/CHRS, ESC, ESO, HRS, ISHNE, NICE on indications and recommended durations for ambulatory ECG monitoring and ILR use in cryptogenic stroke and syncope. It also addresses evolving mobile health technologies and consensus statements on ambulatory ECG monitoring approaches.

The policy includes informational FDA device classification and links for ambulatory ECG devices and mobile cardiac self-monitoring devices (FDA class II 'transmitters and receivers, electrocardiograph, telephone'), and notes ongoing evolution of mobile health tools that require clinical validation. Clinical evidence, trial data, and full references are provided in Part 2 of 2 (clinical evidence, guidelines, and revision history).

Evidence highlights

Post-stroke AF detection rate (RCTs)Approximately 23.7% (per ESC guideline review)

Strength of recommendation for extended monitoring in HCM adults2B - weak (nonrandomized evidence)

Definitions: Cardiac Self-Monitoring Devices — Consumer-grade, connected electronic devices and/or software applications that members can use without a physician's prescription. These devices collect physiologic information to download onto an individual's smart phone, smartwatch, personal computer, or tablet and can be worn on the body as an accessory or embedded into clothing; they may include ECG monitoring capability and associated hardware/software for data download and are considered convenience items and not medically necessary per policy.

Revision History

06/01/2025MaterialLatest

Policy title changed from 'Cardiac Event Monitoring (for Ohio Only)' to 'Implantable Loop Recorders and Wearable Heart Rhythm Monitors (for Ohio Only)' to emphasize Implantable Loop Recorders; coverage rationale language updated to replace general 'cardiac event monitoring' references with specific language that 'Implantable Loop Recorders are proven and medically necessary in certain circumstances' and clarified that wearable self-monitoring devices are not medically necessary.

06/01/2025MaterialLatest

Added policy statement that replacement ILRs are medically necessary when initial criteria continue to be met and the existing device is beyond its useful life span, irreparable, or no longer operating.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyImplantable Loop Recorders and Ambulatory Cardiac Monitoring

Policy CodePolicy N/A

Change TypeTitle change; added pediatric indications; removed CPT codes; wearable devices deemed not medically necessary

Effective DateJune 1, 2025

Next Review DateJun 1, 2025

On This Page

Recurrent or unexplained infrequent syncope, after modification of potentially syncope-causing medications or associated with autonomic dysfunction

Abnormal tests such as electrophysiology study or tilt table testing

Replacement of Implantable Loop Recorders

Replacement is medically necessary when ALL of the following are met:

ALL of the following

Individual continues to meet all initial criteria for insertion described above
Existing device is beyond its useful life span, is irreparable, or no longer operating

Wearable Heart Rhythm Monitors / Cardiac Self-Monitoring Devices

Coverage stance:

Not Medically Necessary

Wearable heart rhythm monitors or Cardiac Self-Monitoring Devices commercially available to the general public and purchased for home use are not medically necessary
Items considered convenience and not medically necessary include but are not limited to: a self-monitoring device that includes an ECG monitor combined with a personal electronic device such as a cellular telephone or watch; hardware or software required for downloading ECG data to a device such as personal computer, tablet, or smart phone

Denial Risk

Denial risk for wearable consumer devices

Claims for wearable heart rhythm monitors or cardiac self-monitoring devices that are commercially available to the general public and purchased for home use are considered not medically necessary and are at risk for denial. Examples include ECG-capable devices combined with a phone or watch and hardware/software for downloading ECG data.

Billing Rule

Removed CPT code usage

Do not bill the CPT codes removed from the applicable codes section; these codes were removed from the policy and are no longer applicable.

93224
93225
93226
93227
93228
93229
93241
93242
93243
93244
93245
93246
93247
93248
93268
93270
93271
93272

06/01/2025MaterialLatest

Added pediatric (Members Under 18 Years of Age) ILR indications specifying ILR is proven and medically necessary when noninvasive cardiac event recording is contraindicated or yielded non-diagnostic results after at least two weeks of monitoring and one or more listed indications (cryptogenic stroke with suspected paroxysmal AF, suspected/known ventricular arrhythmia, high-risk structural/infiltrative heart disease, recurrent unexplained infrequent syncope after medication modification or autonomic dysfunction, and abnormal tests).

06/01/2025MaterialLatest

Removed numerous CPT codes from the applicable codes section (93224, 93225, 93226, 93227, 93228, 93229, 93241, 93242, 93243, 93244, 93245, 93246, 93247, 93248, 93268, 93270, 93271, 93272).

06/01/2025Non-materialLatest

Updated supporting information sections: Clinical Evidence and References to reflect current information; archived previous policy version CS092OH.C.