ModifiedUnitedHealthcarePolicy CS092KY.11

Implantable Loop Recorders and Wearable Heart Rhythm Monitors (for Kentucky Only)

Policy governing medical necessity and coverage of implantable loop recorders (ILRs) and consumer wearable/cardiac self-monitoring devices for UnitedHealthcare members in Kentucky, including adult and pediatric criteria and replacement devices.

Policy Summary

PayerUnitedHealthcare

PolicyImplantable Loop Recorders and Wearable Heart Rhythm Monitors (for Kentucky Only)

Policy CodePolicy CS092KY.11

Change TypeMaterial clinical edits and coding updates

Effective DateJune 1, 2025

Next Review DateN/A

Key ActionObtain and document at least two weeks of noninvasive ambulatory monitoring (or document contraindication) before requesting ILR placement and include specific clinical indication.

SourceLink

POLICY UPDATE CHANGES

Policy title changed from 'Cardiac Event Monitoring (for Kentucky Only)' to 'Implantable Loop Recorders and Wearable Heart Rhythm Monitors (for Kentucky Only)'.

Replaced language to specify that Implantable Loop Recorders are proven and medically necessary in certain circumstances.

Added explicit indications where ILRs are considered medically necessary after at least two weeks of noninvasive monitoring yielding non-diagnostic results or when noninvasive monitoring is contraindicated.

Wearable heart rhythm monitors and consumer cardiac self-monitoring devices purchased for home use are not medically necessary.

CPT code 33286 was added for Implantable Loop Recorder.

Multiple older CPT codes for cardiac event monitoring were removed (list of codes removed).

Updated clinical evidence and references to reflect current literature and guidance.

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for ILRs and Wearable Heart Rhythm Monitors

Medical necessity criteria

Covered when ALL of the following are met (adult guidance references InterQual; pediatric criteria are explicit):

Adult coverage: Adults (>=18 years): ILRs are considered medically necessary in certain circumstances per InterQual CP: Procedures, Electrocardiography, Ambulatory (AECG).

See InterQual criteria for specific adult clinical coverage.

Pediatric initial insertion criteria

Indications list: One or more of: suspected paroxysmal atrial fibrillation in the setting of cryptogenic stroke or another documented systemic thromboembolic event; suspected or known ventricular arrhythmia; high risk for arrhythmia secondary to structural or infiltrative heart disease (examples: 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 QT‑prolonging drugs); recurrent or unexplained infrequent syncope after modification of potentially syncope‑causing medications or associated with autonomic dysfunction; abnormal electrophysiology study or tilt table testing.

Replacement of an existing ILR is medically necessary when the individual continues to meet the initial criteria for insertion and the existing device is beyond its useful life span, is irreparable, or no longer operating.

Applies to adults and pediatric members as stated.

Not medically necessary

Not covered (considered not medically necessary):

Cardiac self-monitoring devices: Wearable heart rhythm monitors and cardiac self‑monitoring devices commercially available to the general public and purchased for home use are not medically necessary due to insufficient evidence of efficacy and are considered convenience items.

Examples include ECG‑enabled watches/phones and hardware or software required for downloading ECG data to a personal computer, tablet, or smart phone.

Guideline-supported ILR indications

Covered when criteria align with major society guideline recommendations or demonstrated clinical trial benefit:

Primary covered indications

Cryptogenic stroke/TIA: Patients with stroke or TIA of undetermined cause when extended monitoring is needed to detect occult AF; ILR is reasonable to improve AF detection.
ACC/AHA/HRS, AHA/ASA, ESO and CCS guidance support prolonged/implantable monitoring.
Infrequent recurrent syncope: Patients with recurrent, infrequent, unexplained syncope after nondiagnostic initial evaluation or when symptoms are too infrequent for short‑term monitoring; ILR can be useful.
ACC/AHA/HRS syncope guidance and expert consensus endorse ILR for infrequent syncope.
Need for maximum AF detection sensitivity: Patients who had a systemic thromboembolic event without known AF and in whom maximum sensitivity to detect AF is sought; implantable monitoring is reasonable.

Implantable Loop Recorder — Medically Necessary Conditions

Implantable Loop Recorders are considered proven and medically necessary when ALL of the following are met (after at least two weeks of noninvasive monitoring that was nondiagnostic, or when noninvasive monitoring is contraindicated):

ILR Medical Necessity Criteria

Clinical circumstances qualifying for ILR: One or more of: 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 (examples: 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 QT‑prolonging drugs); recurrent or unexplained infrequent syncope after modification of potentially syncope‑causing medications or associated with autonomic dysfunction; abnormal electrophysiology study or tilt table testing.

Replacement of Implantable Loop Recorder

Replacement of an existing ILR is considered medically necessary when ALL of the following are met:

ILR Replacement Criteria: The individual continues to meet all initial criteria for insertion and the existing device is beyond its useful life span, is irreparable, or is no longer operating.

Replacement applies to adults and pediatric members as stated in the policy.

Wearable/Cardiac Self-Monitoring Devices — Not Medically Necessary

Wearable heart rhythm monitors and consumer cardiac self‑monitoring devices:

Consumer wearables: Wearable heart rhythm monitors or cardiac self‑monitoring devices commercially available to the general public and purchased for home use are considered not medically necessary due to insufficient evidence of efficacy and are considered convenience items.

Examples include ECG‑enabled watches/phones and hardware/software required for downloading ECG data to a personal computer, tablet, or smart phone; use of such devices may be denied as not medically necessary.

Wearable heart rhythm monitors and consumer cardiac self-monitoring devices that are commercially available to the general public and purchased for home use are not medically necessary. The policy states these products lack sufficient evidence of efficacy and are considered convenience items. Examples include a self-monitoring ECG device combined with a personal electronic device (for example, a cellular telephone or watch) and the hardware or software required to download ECG data to a personal computer, tablet, or smartphone.

Cardiac self-monitoring devices and mobile medical applications (including smartwatches and smartphone ECG apps) are described as convenience items and considered unproven and not medically necessary because of limited high-quality evidence demonstrating improvements in clinical outcomes. While diagnostic accuracy studies and meta-analyses report high sensitivity and specificity for some technologies, the policy emphasizes that evidence of impact on patient-relevant outcomes remains insufficient.

Wearable heart rhythm monitors or cardiac self-monitoring devices that are commercially available to the general public and purchased for home use are excluded from coverage as not medically necessary. The policy explicitly lists such consumer devices (for example, ECG-enabled watches or phones and the associated hardware/software for ECG data download) as examples of excluded items.

Consumer hardware or software that enables downloading of ECG data to personal devices (personal computer, tablet, smartphone, or smartwatch) is considered unproven and not medically necessary. The policy notes these products lack adequate evidence of safety and efficacy for identifying cardiac arrhythmias and therefore are not covered.

Mobile applications and consumer apps that record or download ECG data to a member’s personal device are categorized as unproven and not medically necessary. The policy points to limited or unclear evidence of clinical utility from reviews and evolving evidence assessments and states claims for these consumer applications may be denied as not medically necessary.

Overall, consumer- or patient‑purchased wearable heart rhythm monitors and cardiac self-monitoring devices are not medically necessary because the policy finds insufficient evidence of efficacy. These items are treated as convenience products and may be denied when submitted for coverage.

Applicable Codes and Billing

Implantable Loop Recorder (selected procedures)CPT

0650T	Programming device evaluation (remote) of subcutaneous cardiac rhythm monitor system, with iterative adjustment of the implantable device to test the function of the device and select optimal permanently programmed values with analysis, review and report by a physician or other qualified health care professional.
33285	Insertion, subcutaneous cardiac rhythm monitor, including programming.
33286	Removal, subcutaneous cardiac rhythm monitor.
93285	Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional; subcutaneous cardiac rhythm monitor system

Interrogation and miscellaneous CPT codesCPT

93291	Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter; subcutaneous cardiac rhythm monitor system, including heart rhythm derived data analysis.
93297	Interrogation device evaluation(s), (remote) up to 30 days; implantable cardiovascular physiologic monitor system, including analysis of 1 or more recorded physiologic cardiovascular data elements from all internal and external sensors, analysis, review(s) and report(s) by a physician or other qualified health care professional.
93298	Interrogation device evaluation(s), (remote) up to 30 days; subcutaneous cardiac rhythm monitor system, including analysis of recorded heart rhythm data, analysis, review(s) and report(s) by a physician or other qualified health care professional.
0902T	QTc interval derived by augmentative algorithmic analysis of input from an external, patient- activated mobile ECG device.
93799	Unlisted cardiovascular service or procedure

HCPCS codesHCPCS

E0616	Implantable cardiac event recorder with memory, activator, and programmer.
E1399	Durable medical equipment, miscellaneous

Removed CPT CodesCPT

93224	Removed CPT code
93225	Removed CPT code
93226	Removed CPT code
93227	Removed CPT code
93228	Removed CPT code
93229	Removed CPT code
93241	Removed CPT code
93242	Removed CPT code
93243	Removed CPT code
93244	Removed CPT code

1–10 of 18

1/2

Implantable Loop RecorderCPTCovered

33286

Implantable Loop Recorder insertion

Prior Authorization, Documentation, and Operational Guidance

Prior Authorization

Prior Authorization Required for ILR

Prior authorization is required for insertion (CPT 33285/33286) and ILR‑related services (programming, interrogation, removal). Submit a prior authorization request with documentation that the member meets medical necessity criteria per InterQual Ambulatory ECG (AECG) and the policy’s clinical indications before scheduling implantation.

Affected codes: CPT 33285, 33286, 93285, 93291, 93297, 93298, 0650T, 93285
Prior authorization must include InterQual AECG–based clinical justification and relevant clinical records

Denial Risk

Denial Risk: Consumer Cardiac Self‑Monitoring Devices

Wearable heart rhythm monitors and consumer cardiac self‑monitoring devices purchased for home use are considered convenience items and are not medically necessary. These devices lack sufficient evidence of efficacy for diagnosing arrhythmias and coverage may be denied.

Background and Clinical Context

Cardiac arrhythmias may be symptomatic or silent and often require ambulatory electrocardiographic monitoring to establish a diagnosis. The choice of monitoring modality and duration depends on symptom frequency: short-term external monitors (for example, Holter monitors for 24–48 hours or patch monitors for up to 14 days) are appropriate for frequent symptoms, while prolonged continuous monitoring with an Implantable Loop Recorder (ILR) provides higher long-term arrhythmia detection rates and is useful when symptoms are infrequent, when noninvasive monitoring is nondiagnostic, or when maximum sensitivity for detecting atrial fibrillation is desired. The policy requires an initial trial of noninvasive ambulatory monitoring (guided by symptom frequency) for at least two weeks unless noninvasive monitoring is contraindicated prior to considering ILR placement.

Key Definitions

inv-31: Cardiac Self-Monitoring Devices — consumer-grade connected devices and software definition

Typical functionsGenerate measurements and data such as blood pressure, heart rate, and heart rhythm via sensors and algorithms (eg, ECG/PPG-based detection).

Clinical stance in policyConsidered convenience items and unproven for identifying cardiac arrhythmias; use of consumer cardiac self-monitoring devices purchased for home use is not medically necessary.

ExamplesECG-enabled smartwatches/phones and associated hardware/software for downloading ECG data to personal devices.

inv-32: Implantable Loop Recorder — definition of subcutaneous device that records electrical activity

Primary useHelps determine causes of palpitations or fainting spells, particularly when symptoms are infrequent and not captured by short-term monitors.

Policy note

Policy Revision History

2025-06-01title_change and scope_clarificationLatest

Policy title changed from 'Cardiac Event Monitoring (for Kentucky Only)' to 'Implantable Loop Recorders and Wearable Heart Rhythm Monitors (for Kentucky Only)', and coverage language was revised to specify Implantable Loop Recorders as proven and medically necessary in certain circumstances and to clarify the stance on wearable cardiac self-monitoring devices.

2025-06-01criteria_added

Added explicit medical necessity criteria stating ILRs are proven and medically necessary when noninvasive monitoring was contraindicated or nondiagnostic after at least two weeks and one or more listed clinical circumstances (e.g., cryptogenic stroke with suspected paroxysmal AF, ventricular arrhythmia, high arrhythmia risk from structural/infiltrative disease, recurrent unexplained infrequent syncope, abnormal EP or tilt testing) are present.

Policy Summary

PayerUnitedHealthcare

PolicyImplantable Loop Recorders and Wearable Heart Rhythm Monitors (for Kentucky Only)

Policy CodePolicy CS092KY.11

Change TypeMaterial clinical edits and coding updates

Effective DateJune 1, 2025

Next Review DateN/A

Key ActionObtain and document at least two weeks of noninvasive ambulatory monitoring (or document contraindication) before requesting ILR placement and include specific clinical indication.

SourceLink

On This Page

Denial Risk

Denial Risk: Consumer Device Data and Apps

Consumer mobile medical applications and commercially available cardiac self‑monitoring devices are considered unproven and may be denied when submitted as a medical necessity request. Do not substitute consumer device data for required diagnostic testing without corroborating clinical documentation.

Devices include consumer smartwatches, phone‑based ECG attachments, and associated download software
If consumer device data is included, provide confirmatory, clinically‑interpretable evidence (e.g., physician‑overread ECG, ambulatory monitor report)

Documentation Required

Documentation Prerequisite for ILR

Coverage for ILR insertion requires documentation of prior noninvasive ambulatory monitoring unless clinically contraindicated. Providers should document the type and duration of prior monitoring and the non‑diagnostic results that justify proceeding to ILR.

Minimum recommended trial: at least two weeks of continuous or intermittent noninvasive monitoring (e.g., patch, event monitor, MCOT) unless contraindicated
Document dates, device type, monitoring reports, and explanation why noninvasive testing was nondiagnostic or not feasible

Documentation Required

Clinical Criteria Documentation

Clinical criteria documentation must reference InterQual Ambulatory ECG (AECG) criteria for adults and include indication‑specific evidence (e.g., cryptogenic stroke workup, syncope evaluation, abnormal EP/tilt table, structural heart disease). For pediatric members, document compliance with the policy’s age‑specific criteria.

Cite InterQual AECG decision support findings in the prior authorization submission
Include relevant clinical findings: stroke/TIA history, frequency of syncope, results of prior testing (Holter, event monitor, patch, EP study, tilt table)

Documentation Required

Indication and Supporting Documentation

Indication and supporting documentation should explicitly state the guideline‑consistent reason for ILR and provide objective supporting data. Acceptable indications include cryptogenic stroke/TIA for AF detection, infrequent unexplained syncope after medication review, suspected or known ventricular arrhythmia, high arrhythmic risk from structural/infiltrative disease, or diagnostic abnormalities on electrophysiology or tilt testing.

For cryptogenic stroke/TIA: provide stroke workup summary and prior external monitoring results
For syncope: document symptom frequency, medication adjustments tried, and prior noninvasive testing results
For ventricular arrhythmia or high‑risk structural disease: include imaging, ECG, family history, or medication exposure details

Documentation Required

Required Clinical Documentation

Required clinical documentation for ILR prior authorization includes: clinical indication tied to guideline criteria, results of at least two weeks of prior noninvasive monitoring (or rationale for exemption), summaries of prior diagnostic testing, and a clinician statement that ILR insertion is medically necessary for ongoing evaluation.

Minimum dataset to submit: indication, InterQual AECG output (if used), prior monitoring reports with dates, clinician narrative, and relevant imaging or EP/tilt study reports
Failure to provide the required documentation may result in denial of the request

Note

Noninvasive Monitoring Preferred Before ILR

Noninvasive monitoring is preferred before ILR insertion. When feasible, begin with external ambulatory monitoring (Holter, patch, event monitor, MCOT) tailored to symptom frequency and patient ability to comply. Use ILR when noninvasive methods are nondiagnostic or not feasible.

Consider MCOT or patch monitors for patients able to comply for at least four weeks; MCOT may detect AF earlier in some cohorts
For frequent symptoms, shorter duration Holter or patch may be appropriate; for infrequent symptoms, consider longer external event monitors before ILR

Note

Noninvasive‑First Approach

Noninvasive‑first approach: guidelines recommend initial use of short‑term and extended external monitors based on symptom frequency. Reserve ILR for patients with infrequent events, nondiagnostic prior monitoring, inability to comply with external monitoring, or when maximum sensitivity for AF detection is required (e.g., embolic stroke of undetermined source).

Tailor choice and duration of external monitoring to symptom interval (Holter 24–48 hrs, patch 7–14 days, event/loop monitors up to 30 days, ambulatory telemetry/MCOT up to 30 days)
If external monitoring for a guideline‑appropriate duration is nondiagnostic, document results before ILR authorization

inv-33: Insertable Cardiac Monitor (ICM) / ILR — definition and clinical use

DefinitionInsertable Cardiac Monitor (ICM)/Implantable Loop Recorder (ILR) is a subcutaneously implanted device for long-term ambulatory cardiac rhythm monitoring to detect intermittent arrhythmias when noninvasive monitoring is inconclusive or maximum sensitivity is needed.

Clinical applicationsUsed for extended monitoring to detect occult AF after cryptogenic stroke/TIA, evaluation of infrequent unexplained syncope, surveillance for AF-induced cardiomyopathy, and detection of ventricular arrhythmias or high arrhythmia risk conditions.

Guideline alignmentMajor society guidelines (eg, ACC/AHA/HRS) support ILR use when external ambulatory monitoring is inconclusive for cryptogenic stroke and for infrequent symptoms not captured by short-term monitoring.

inv-34: Cardiac self-monitoring devices / Mobile Medical Applications (MMAs) — definition including smartwatches, PPG, single-lead ECG apps

DefinitionCardiac self-monitoring devices and Mobile Medical Applications (MMAs) are consumer or mobile technologies (smartwatches, smartphone single-lead ECG apps, PPG-based sensors) that record or analyze heart rhythm data outside of clinical-grade monitors.

Common modalitiesPhotoplethysmography (PPG) and single-lead ECG implemented in smartwatches and phone apps for AF detection; often paired with algorithms/AI for interpretation.

Evidence/limitationsDiagnostic accuracy studies show high sensitivity/specificity for PPG and single-lead ECG, but policy cites lack of quality research demonstrating clinical outcome benefit; therefore considered unproven for routine medical coverage.

inv-35: Noninvasive ambulatory monitoring — external modalities definitions (Holter, patch, event monitors, MCOT)

DefinitionNoninvasive ambulatory monitoring comprises external modalities such as Holter monitors (typically 24–48 hours), patch monitors (7–14 days), event/loop monitors (up to 30 days), and ambulatory cardiac telemetry (up to 30 days).

Selection principleChoice of modality and duration is guided by symptom frequency: shorter-term monitoring for frequent symptoms, longer-term or intermittent monitors for less frequent events.

Policy requirement before ILRPolicy requires an initial trial of noninvasive ambulatory monitoring with duration guided by symptom frequency prior to ILR placement unless noninvasive monitoring is contraindicated.

inv-36: Implantable Loop Recorder (ILR) — additional definition for long-term monitoring utility

Definition and utilityAn Implantable Loop Recorder (ILR) is a subcutaneously implanted device for long-term cardiac rhythm monitoring useful for detecting infrequent or subclinical arrhythmias, including occult AF after cryptogenic stroke, when noninvasive monitoring is insufficient.

Clinical benefitProvides prolonged continuous monitoring with higher long-term arrhythmia detection rates compared with short-term external monitors, and is reasonable when maximal detection sensitivity is required.

Replacement considerationReplacement of ILR is medically necessary when initial criteria continue to be met and the existing device is beyond its useful life, irreparable, or nonoperational.

inv-37: Consumer cardiac self-monitoring devices / Wearable heart rhythm monitors — examples and exclusion rationale

ExamplesCommercially available wearable devices such as ECG-enabled smartwatches or phone-based ECG monitors and the associated hardware/software used to download ECG data to personal devices.

Policy exclusion rationaleThese consumer/patient-purchased wearable heart rhythm monitors and associated download hardware/software are considered convenience items with insufficient evidence of efficacy; therefore they are not medically necessary.

Scope of exclusionIncludes self-monitoring ECG devices combined with a personal electronic device and any required hardware/software for downloading ECG data (eg, personal computer, tablet, smartphone).