ModifiedUnitedHealthcarePolicy CS092NJ.W

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

This policy governs medical necessity and coverage for implantable loop recorders (ILRs) and wearable or consumer cardiac self-monitoring devices for UnitedHealthcare members in New Jersey.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS092NJ.W

Change TypeTitle and coverage language revisionsCPT list updated

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionVerify benefit coverage and prior authorization requirements for ILR insertion and related services before scheduling.

SourceLink

POLICY UPDATE CHANGES

Title changed from 'Cardiac Event Monitoring (for New Jersey Only)' to 'Implantable Loop Recorders and Wearable Heart Rhythm Monitors (for New Jersey Only)'.

Removed language indicating ambulatory event monitoring (Holter monitor, event monitor) and patch-type monitor and outpatient cardiac telemetry are proven and medically necessary for evaluating suspected cardiac arrhythmias.

Replaced prior wording about wearable heart rhythm monitors being not medically necessary with revised phrasing that includes 'wearable heart rhythm monitors or Cardiac Self-Monitoring Devices commercially available to the general public and purchased for home use are not medically necessary'.

Removed definitions for Ambulatory Event Monitoring/ECG, Attended Surveillance, and Outpatient Cardiac Telemetry.

Updated definition of 'Implantable Loop Recorder'.

Removed multiple CPT codes from the Applicable Codes list (listed collectively).

Updated Description of Services, Clinical Evidence, and References to reflect most current information.

>=2 weeksminimum prior noninvasive monitoring duration before ILR considered

28.5%

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Coverage Criteria — ILR and Consumer Cardiac Devices

Initial ILR insertion

Covered when ALL of the following are met:

ILR initial insertion criteria: Implantable Loop Recorders are medically necessary when noninvasive cardiac event recording is contraindicated or yielded non-diagnostic results after at least 2 weeks of monitoring and the individual has one or more of the following: suspected paroxysmal atrial fibrillation in the setting of a cryptogenic stroke or other documented systemic thromboembolic event; suspected or known ventricular arrhythmia; high risk for arrhythmia secondary to structural or infiltrative heart disease (examples include 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 when associated with autonomic dysfunction; or abnormal tests such as electrophysiology study or tilt-table testing.at least 2 weeks of prior noninvasive monitoring unless contraindicated

High-risk structural conditions examples: aortic stenosis, hypertrophic cardiomyopathy, cardiac sarcoidosis, congenital heart disease, family history, dilated ischemic or nonischemic cardiomyopathy, or use of QT‑prolonging medications.

Replacement ILR

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

Covered indications and monitoring sequence

Covered when consistent with society guideline recommendations and after appropriate initial evaluation:

ILR reasonable indications: ILR implantation is reasonable when initial noninvasive cardiac monitoring is nondiagnostic and the clinical context includes: cryptogenic stroke/TIA when maximum sensitivity to detect AF is sought; infrequent recurrent syncope suspected to be arrhythmic in origin; evaluation or surveillance in AF-induced cardiomyopathy recovery; or high pretest probability of clinically significant ventricular arrhythmia.N/A

Derived from ACC/AHA/HRS, AHA/ACC, and AHA/ASA guidance

Situations favoring extended monitoring: Consider extended or implantable monitoring for: cryptogenic stroke/TIA without known AF, patients with infrequent symptoms (>30 days) suspected due to bradycardia, recurrent unexplained syncope after nondiagnostic workup, and select high-risk hypertrophic cardiomyopathy patients for AF surveillance.N/A

References: ACC/AHA/HRS, Kusumoto 2019, AHA/ACC HCM guidance

Monitoring modality selection

Clinical guidance and sequencing for monitoring modalities (informational):

Monitoring selection logic: Select monitoring modality based on symptom frequency: use short-term continuous ambulatory ECG (24–48 hours up to 7 days) for frequent symptoms; use longer external monitoring (event/loop monitors up to 30 days, patch monitors 7–14 days, ambulatory telemetry up to 30 days) for less frequent symptoms; if prolonged noninvasive monitoring is unsuccessful, consider ILR.

Based on HRS/ISHNE consensus and NICE guidance

NICE monitoring criteria for suspected paroxysmal AF

NICE recommendation for suspected paroxysmal atrial fibrillation not detected on 12‑lead ECG:

NICE AF monitoring recommendations: For suspected paroxysmal AF undetected by 12‑lead ECG: use a 24‑hour ambulatory ECG monitor for suspected asymptomatic episodes or symptomatic episodes less than 24 hours apart; use an ambulatory ECG monitor, event recorder, or other ECG technology for symptomatic episodes more than 24 hours apart.

NICE NG196 (2021)

ILR use after cryptogenic stroke

NICE guidance related to ILR after cryptogenic stroke:

ILR after cryptogenic stroke (NICE): The Reveal LINQ ILR can be used to identify AF following a cryptogenic stroke, including TIA, but only when non‑invasive ECG monitoring has been performed and a cardiac arrhythmia is still suspected as the cause of the stroke.

NICE DG41 (2020)

Cardiac self-monitoring devices (not medically necessary)

Cardiac self-monitoring devices stance: Cardiac self-monitoring devices and consumer-grade mobile medical applications (including smartwatches and phone‑based single‑lead ECG systems and associated hardware/software for downloading data) are considered not medically necessary due to insufficient evidence demonstrating improved clinical outcomes and are treated as convenience items when purchased for home use.insufficient evidence

Includes devices and software that download ECG data to personal computers, tablets, smartphones, or smartwatches.

Wearable heart rhythm monitors or Cardiac Self-Monitoring Devices that are commercially available to the general public and purchased for home use are not medically necessary. The policy treats these consumer-grade devices and their required hardware/software (for example, an ECG monitor combined with a personal electronic device or tools to download ECG data to a personal computer, tablet, or smartphone) as convenience items due to insufficient evidence of safety and efficacy for identifying cardiac arrhythmias.

Replacement and revision history clarifies that this policy statement was updated to explicitly designate wearable heart rhythm monitors or Cardiac Self‑Monitoring Devices purchased for home use as not medically necessary under the plan; providers should expect such claims to be subject to denial unless coverage criteria for an FDA‑cleared, prescription-based medical monitoring device are met.

Consumer mobile medical applications (MMAs) and wearable devices have not demonstrated clear improvement in patient health outcomes when compared with alternative monitoring modalities. An external evidence review (Hayes 2021, updated 2023) found no consistent demonstration that MMAs improve clinical outcomes despite higher arrhythmia detection rates in some small studies, and the Apple Heart Study and similar large pragmatic investigations showed high participation but important limitations in follow-up and confirmatory testing.

Because of these evidence gaps and limitations (including variable study sizes, incomplete confirmatory testing, and unclear impact on management or clinical outcomes), MMAs and consumer wearable devices remain designated as not medically necessary for routine screening or diagnostic use without an established clinical indication.

Wearable heart rhythm monitors or Cardiac Self‑Monitoring Devices that consumers buy for home use (for example, smartwatch systems with irregular-pulse notifications or phone-based single‑lead ECG applications and associated download hardware/software) are considered not medically necessary and are treated as convenience items. They lack sufficient high-quality evidence to support routine coverage for diagnostic evaluation of suspected arrhythmias.

Providers submitting claims for monitoring or interpretation related to consumer-grade devices should document the device type and clinical justification; however, under this policy such consumer devices are expected to be denied unless they meet criteria for prescription medical monitoring devices or other covered technologies.

Consumer‑grade self‑monitoring devices and mobile medical applications are considered not medically necessary because available studies do not provide sufficient high‑quality evidence of clinical benefit. Systematic and evidence reviews have highlighted small study sizes, short follow‑up, and inconsistent demonstration of improved clinical outcomes.

Specific study limitations—such as the Apple Heart Study’s low return rate for confirmatory ECG patches and variable adherence in randomized trials—underscore the risk that detection by consumer devices may not translate into actionable, verified diagnoses or improved patient outcomes without appropriate confirmatory testing and follow‑up.

The policy stance reflects the findings of systematic reviews (Hayes and others) and important trial limitations such as those reported in the Apple Heart Study: although large numbers of participants received device notifications, many did not return confirmatory monitoring or complete follow‑up, limiting the ability to assess true diagnostic yield and downstream clinical benefit.

Consequently, use of consumer wearable or smartphone‑based monitoring for asymptomatic screening in low‑risk populations without a clear clinical indication or plan for confirmatory testing is considered not medically necessary because demonstrated improvements in clinical outcomes are lacking.

Wearable heart rhythm monitors or Cardiac Self‑Monitoring Devices commercially available to the general public and purchased for home use (including smartwatch irregular‑pulse notifications and phone‑based single‑lead ECG apps plus associated hardware/software) are designated not medically necessary due to insufficient evidence of efficacy for diagnostic use.

Providers should distinguish these consumer devices from prescription or clinician‑directed monitoring systems; only FDA‑cleared, clinician‑prescribed monitoring modalities with supporting evidence and appropriate documentation are considered for coverage under the plan.

Applicable Codes and Billing

Applicable CPT Codes and related unlisted codesCPT

0650T	Programming device evaluation (remote) of subcutaneous cardiac rhythm monitor system
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
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

Applicable HCPCS CodesHCPCS

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

Removed CPT CodesCPT

93224	CPT code removed from Applicable Codes list
93225	CPT code removed from Applicable Codes list
93226	CPT code removed from Applicable Codes list
93227	CPT code removed from Applicable Codes list
93228	CPT code removed from Applicable Codes list
93229	CPT code removed from Applicable Codes list
93241	CPT code removed from Applicable Codes list
93242	CPT code removed from Applicable Codes list
93243	CPT code removed from Applicable Codes list
93244	CPT code removed from Applicable Codes list

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Prior noninvasive monitoring — at least 2 weeks

Required prior monitoring durationAt least 2 weeks of prior noninvasive cardiac monitoring (unless contraindicated)

Purpose of prior monitoringEstablish non-diagnostic results or contraindication to noninvasive monitoring before ILR insertion

Situations where waiver may applyWhen noninvasive monitoring is contraindicated (e.g., inability to tolerate external monitors)

Prior Authorization, Documentation, and Workflow

Prior Authorization

Verify prior authorization & code applicability

Verify benefit coverage and prior authorization requirements for insertion, removal, programming, interrogation, and remote monitoring of implantable loop recorders (ILRs) before scheduling services. Confirm the applicability of listed procedure and HCPCS codes to the patient’s plan and billing scenario; the codes in this policy are for reference and do not guarantee payment.

Affected codes include but are not limited to: CPT 33285, 33286, 93285, 93291, 93297, 93298, unlisted 93799; HCPCS E0616, E1399; temporary codes such as 0650T and 0902T where applicable.

Prior Authorization

Prior authorization for ILR may be required

Prior authorization may be required for ILR implantation and associated services depending on the member’s benefit plan. Providers should obtain any required prior authorization before implant and verify whether separate authorizations are required for device implantation, removal, programming, or extended remote monitoring services.

Check for plan-specific requirements for implantation, device removal, and remote interrogation services.

Background and Rationale

Cardiac arrhythmias may be symptomatic (palpitations, dizziness, syncope) or asymptomatic; selection of ambulatory ECG monitoring modality and duration should be tailored to symptom frequency and the clinical question. Shorter‑term continuous ambulatory ECG monitoring (for example, 24–48 hours up to 7 days) is appropriate for frequent symptoms, while longer external monitoring (patch monitors, event/loop monitors, ambulatory telemetry) may be used for less frequent symptoms.

When noninvasive monitoring is contraindicated or has been nondiagnostic after an appropriate period (typically at least 2 weeks of prior noninvasive monitoring unless contraindicated), Implantable Loop Recorders (ILRs) provide long‑term continuous subcutaneous rhythm monitoring and are considered medically necessary for defined indications such as suspected paroxysmal atrial fibrillation after cryptogenic stroke, suspected or known ventricular arrhythmia, certain high‑risk structural heart disease, recurrent unexplained infrequent syncope, or abnormal electrophysiology/tilt‑table testing.

Definitions

Cardiac Self-Monitoring Devices — Consumer-grade, connected electronic devices and/or software applications

DefinitionConsumer-grade, connected electronic devices and/or software applications that members can use without a physician's prescription to collect physiologic information and download to personal devices (smartphone, smartwatch, PC, tablet).

ExamplesSmartwatches and smartphone ECG accessories, hardware or software for downloading ECG data to a personal device.

Policy stanceDesignated not medically necessary when commercially available and purchased for home use due to insufficient evidence of efficacy; considered convenience items.

Implantable Loop Recorder — Device placed under the skin that continuously records cardiac electrical activity

DefinitionDevice placed under the skin that continuously records cardiac electrical activity and can transmit data to a physician to help diagnose infrequent palpitations or fainting spells.

Revision History and Policy Changes

2025-06-01title_changeLatest

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

2025-06-01coverage_rationale_revision

Removed language stating ambulatory event monitoring modalities (including Holter monitor and event monitor) are proven and medically necessary for evaluating suspected cardiac arrhythmias.

2025-06-01

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS092NJ.W

Change TypeTitle and coverage language revisionsCPT list updated

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionVerify benefit coverage and prior authorization requirements for ILR insertion and related services before scheduling.

SourceLink

On This Page

Prior Authorization

Verify plan-specific prior authorization requirements

Check federal, state, and contractual benefit plan requirements and any plan-specific prior authorization processes. In the event of a conflict between this policy and applicable federal, state, or contractual requirements, those requirements govern coverage decisions.

State Medicaid fee schedules may exclude certain CPT/HCPCS codes (e.g., codes marked with an asterisk).
Use plan-specific prior authorization portals or call the payer for confirmation when unclear.

Denial Risk

Denial risk for consumer cardiac self-monitoring devices

Wearable consumer cardiac self-monitoring devices and other commercially available home-use heart rhythm monitors are considered not medically necessary for coverage in this policy. Use of these consumer-grade devices carries a denial risk when billed as covered medical devices or durable medical equipment.

Examples include single-lead smartphone ECGs paired with a phone or watch, consumer smartwatches with irregular rhythm notification, and associated software or download hardware.
Claims for such consumer devices may be denied as convenience items due to insufficient evidence of efficacy.

Documentation Required

Documentation risks from study follow-up gaps

Documentation gaps such as failure to return ECG patches, incomplete monitoring data, or poor follow-up response rates can limit the ability to confirm arrhythmia and may lead to claim denials or requests for additional information. Ensure complete capture and retention of monitoring data and study follow-up documentation.

Document date ranges and duration of each monitoring modality, number of days worn, and whether the device was returned and analyzed.
Retain and include ECG recordings, interpretation reports, and clinician review notes when submitting claims or authorization requests.

Billing Rule

Coding and documentation note

Procedure and billing codes listed in this policy are provided for reference and may be used to support claims or authorization requests but do not guarantee coverage or reimbursement. Verify code applicability to the specific service performed and the patient’s benefit plan.

Inclusion of a code in this policy is not authorization for payment; state Medicaid fee schedules may not cover codes marked with an asterisk.
Use correct CPT/HCPCS codes for insertion (e.g., 33285), removal (33286), in-person programming/interrogation (93285, 93291), and remote interrogation (93297, 93298).

Documentation Required

Required monitoring documentation

Document the monitoring modality used, duration of monitoring, device model, activation and deactivation dates, and clinical indications for monitoring. Include clinician review and interpretation reports, any transmitted remote monitoring summaries, and evidence of prior noninvasive testing when applicable.

Record the reason for ILR (e.g., cryptogenic stroke, syncope, suspected ventricular arrhythmia) and prior noninvasive monitoring attempts (type and duration).
Include device serial number/model and documentation of informed consent and discussion of noninvasive alternatives.

Note

Noninvasive monitoring preferred before ILR

Noninvasive extended monitoring (for example, MCOT, ambulatory patch monitors, external loop recorders) should be considered prior to ILR insertion for many indications, particularly for patients able to comply with external monitoring, consistent with guideline recommendations.

MCOT or patch monitoring for up to 4 weeks can detect a significant proportion of AF and may be preferred as an initial strategy in suitable patients.
Document patient capacity for and trial of noninvasive monitoring when submitting for authorization of an ILR.

Note

Recommended monitoring sequence

Recommended clinical workflow: begin with short-term continuous ambulatory monitoring (24–72 hours, up to 7 days) and, if nondiagnostic, progress to longer external monitoring (patches or MCOT up to ~30 days). If extended noninvasive monitoring is nondiagnostic and clinical suspicion remains, consider ILR implantation for prolonged continuous monitoring.

Short-term: Holter 24–48 hours for daily symptoms.
Intermediate: Patch monitors 7–14 days or external event/loop monitors up to 30 days for less frequent symptoms.
Long-term: ILR for infrequent or unexplained events after nondiagnostic noninvasive testing.

Note

Preferred monitoring sequence

Preferred sequence guidance (concise): start with shorter-term continuous ambulatory ECG (24 hours up to 7 days); if nondiagnostic and symptoms are infrequent, consider intermittent external loop recording or MCOT (up to ~30 days); if still nondiagnostic and clinical suspicion persists, ILR is appropriate for long-term monitoring.

Tailor monitoring choice and duration to symptom frequency and diagnostic goal.
Document prior noninvasive modalities and durations before ILR authorization or implantation.

PPG — Photoplethysmography used in consumer devices

DefinitionPhotoplethysmography (PPG): an optical technique used by many smartwatches and consumer devices to detect pulse irregularities indicative of atrial fibrillation.

Diagnostic performancePooled sensitivity and specificity for PPG detection of AF were 95.1% and 96.2% in a 31-study meta-analysis, but unclassified tracings ranged widely and further outcome data are needed.

Clinical noteHigh diagnostic accuracy reported in accuracy studies does not by itself establish clinical outcome benefit; policy treats consumer PPG-based devices as not medically necessary when purchased for home use.

single-lead ECG — One-lead electrocardiographic recording used in consumer devices

DefinitionSingle-lead ECG: a one-lead electrocardiographic recording commonly used in smartphone or portable ECG devices for rhythm assessment.

Performance and limitationsMeta-analysis pooled sensitivity/specificity for single-lead ECG detection of AF were 92.3% and 96.2%; single-lead devices may yield unclassified tracings and false positives (e.g., KardiaMobile study showed 13.1% unclassified and substantial false positives).

Policy implicationDespite reasonable diagnostic accuracy, smartphone single-lead ECG devices purchased for home use are considered not medically necessary for routine screening without clinical indication.

Implantable Loop Recorder (ILR) — Long-term implanted cardiac rhythm monitor

DefinitionImplantable Loop Recorder (ILR): an implanted device for long-term continuous cardiac rhythm monitoring used when noninvasive monitoring has not identified the cause of suspected arrhythmia.

IndicationsAppropriate for suspected paroxysmal AF after cryptogenic stroke/TIA, suspected or known ventricular arrhythmia, high-risk structural/infiltrative heart disease, recurrent unexplained infrequent syncope, or abnormal electrophysiology/tilt-table testing when noninvasive monitoring was nondiagnostic after ≥2 weeks.

Role in monitoring sequenceConsider ILR when prolonged noninvasive monitoring (short-term continuous ECG, patch, event/loop monitors, ambulatory telemetry) is nondiagnostic; follows HRS/ISHNE guidance on escalation of monitoring modalities.