ModifiedUnitedHealthcarePolicy CSO92PA.U

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

This policy governs medical necessity and coverage of implantable loop recorders (ILRs) and consumer cardiac self-monitoring devices for UnitedHealthcare members in Pennsylvania; it defines when ILRs and replacements are covered and states that consumer wearable/portable ECG devices are not medically necessary.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CSO92PA.U

Change TypeTitle and coverage language revisions

Effective DateJun 1, 2025

Next Review Date

Key ActionObtain prior authorization documenting medical necessity and prior noninvasive monitoring attempts (at least two weeks) before ILR insertion or replacement.

SourceLink

POLICY UPDATE CHANGES

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

Removed language listing ambulatory event monitoring, Holter monitor, event monitor, patch-type monitor, and outpatient cardiac telemetry as 'proven and medically necessary' for evaluating suspected cardiac arrhythmias.

Replaced statement that consumer cardiac self-monitoring devices 'commercially available to the general public and purchased for home use are not medically necessary' with an updated phrasing that 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/Electrocardiography (ECG), Attended Surveillance, and Outpatient Cardiac Telemetry.

Updated definition of 'Implantable Loop Recorder'.

Pennsylvania-onlystate applicability

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1policy replaced/archived prior version

21.7% vs 2.4%STROKE-AF trial result

Not medically necessarystance on consumer devices

~28.5%ILR AF detection (36 mo)

Coverage Criteria

Medically necessary ILR insertion and replacement

Covered when ALL of the following are met:

Initial ILR insertion: Noninvasive cardiac event recording is contraindicated OR was non-diagnostic after at least two weeks of monitoring, AND the individual has one or more of the following clinical circumstances: suspected paroxysmal atrial fibrillation after cryptogenic stroke or other documented systemic thromboembolic event; suspected or known ventricular arrhythmia; high risk for arrhythmia due to structural or infiltrative heart disease (for example 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; or abnormal tests such as electrophysiology study or tilt table testing.at least two weeks of noninvasive monitoring

Matches policy Coverage Rationale

Replacement of ILR: Replacement of an implantable loop recorder is medically necessary when the individual continues to meet all initial insertion criteria and the existing device is beyond its useful life span, is irreparable, or is no longer operating.device beyond useful life/irreparable/not operating

Replacement must meet same clinical indications as initial insertion

Guideline-based coverage indications

Covered when guideline-based indications are met, according to society recommendations summarized here:

Post-cryptogenic stroke/TIA: For patients with cryptogenic stroke or TIA (or systemic thromboembolism) without a known history of AF, when maximum sensitivity to detect AF is sought, extended monitoring or an ILR is reasonable to optimize AF detection.

Supported by ACC/AHA/ACCP/HRS, AHA/ASA, ESC, ESO statements

Infrequent suspected arrhythmic syncope: In patients with infrequent recurrent syncope of suspected arrhythmic origin and a nondiagnostic initial evaluation, long-term ambulatory monitoring with an ICM/ILR is reasonable and may be useful to establish a rhythm diagnosis.

Supported by ACC/AHA/HRS, ESC, Canadian guidelines

AF-induced cardiomyopathy surveillance: For patients with AF-induced cardiomyopathy who have recovered left ventricular function, long-term surveillance with extended monitoring or ILR can be reasonable to detect recurrent AF.

Supported by ACC/AHA/ACCP/HRS guidance

Not medically necessary — consumer devices

Consumer cardiac self-monitoring devices: Wearable heart rhythm monitors or cardiac self-monitoring devices that are commercially available to the general public and purchased for home use (including devices that integrate an ECG monitor with a personal electronic device, and hardware or software for downloading ECG data to personal computers, tablets, smartphones or watches) are not medically necessary due to insufficient evidence of efficacy and are considered convenience items.insufficient evidence

Consumer-device notifications alone are insufficient without confirmatory diagnostic monitoring

Wearable heart rhythm monitors and other consumer-grade cardiac self-monitoring devices purchased for home use (including hardware or software used to download ECG data to a personal computer, tablet, smartphone, or smartwatch) are classified as not medically necessary. The policy treats these items as convenience devices because current evidence does not demonstrate sufficient safety and efficacy to support their routine coverage for identifying cardiac arrhythmias. Replacement of an ILR is addressed separately and is covered only when the individual continues to meet ILR insertion criteria and the existing device is beyond its useful life or is irreparable or nonfunctioning; consumer wearables remain noncovered regardless of ILR status.

Consumer-device notifications (for example, irregular-pulse alerts from smartwatches) are insufficient by themselves to establish a diagnosis and generally require confirmatory diagnostic monitoring before clinical decisions. Large pragmatic studies (Apple Heart Study) and randomized trials (Koh et al., 2021) show that many notifications do not translate into confirmed atrial fibrillation (AF) without follow-up ECG patch or clinician-reviewed tracings, and that a substantial fraction of single-lead or app-classified recordings are unclassified or false positive. Study limitations — including low return rates for confirmatory patches in site-less studies, variable adherence, single-lead recordings, and limited durations — further restrict generalizability and support the need for formal diagnostic testing rather than relying on consumer-device alerts alone.

UnitedHealthcare designates wearable heart rhythm monitors and Cardiac Self-Monitoring Devices that are commercially available to the general public and purchased for home use as not medically necessary. Examples include self-monitoring devices that combine an ECG monitor with a personal electronic device (phone or watch) and the hardware/software required to download ECG data to personal devices. This policy language was retained and clarified in the 06/01/2025 revision to explicitly list wearable heart rhythm monitors in the noncoverage statement.

Cardiac self-monitoring devices and mobile applications that download ECG data to personal devices are considered convenience items and unproven for routine diagnostic use. The policy cites a lack of high-quality research demonstrating safety and efficacy for identifying arrhythmias with these consumer systems, and therefore they are not covered as a medically necessary diagnostic option.

Routine smartphone-based monitoring used solely to attempt to improve health-related quality of life (HRQOL) in patients already receiving treatment for atrial fibrillation is not supported by available randomized trial data. Trials such as the iHEART study showed no statistically significant HRQOL, QALY, or AF symptom-severity benefit attributable to smartphone-based monitoring versus usual care in treated populations, and authors recommended further research with longer follow-up and broader populations before routine use for HRQOL improvement.

As reiterated elsewhere in this policy, wearable heart rhythm monitors or Cardiac Self-Monitoring Devices that are widely sold to consumers and purchased for home use are not medically necessary. The policy emphasizes that such devices are considered convenience items and are excluded from coverage because of insufficient evidence to support their routine clinical use for arrhythmia diagnosis.

Coding

Applicable CPT codesCPT

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.
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.
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.

No explicit codes in this excerptmixed

No codes listed

Prior noninvasive monitoring duration — at least two weeks

Required duration of prior noninvasive monitoringAt least two weeks of noninvasive cardiac event recording (unless contraindicated)

When considered satisfiedNoninvasive monitoring documented as performed for >=2 weeks and yielded non-diagnostic results

ExceptionNoninvasive monitoring may be bypassed when it is contraindicated; documentation must state the contraindication

AF episode duration used in key trial — >= 30 seconds

AF episode duration threshold in key trial>= 30 seconds (used as the diagnostic threshold in the 30-day smartphone ECG vs 24‑hour Holter RCT)

Study context

Provider Actions & Administrative Requirements

Prior Authorization

Prior Authorization Required for ILR Insertion/Replacement

Prior authorization is required for insertion or replacement of an Implantable Loop Recorder (ILR). Requests must document medical necessity and include pertinent CPT/HCPCS codes and clinical information supporting the indication (see Applicable Codes). Replacement requests must also document that the member continues to meet initial insertion criteria and that the existing device is beyond its useful life, irreparable, or no longer operating.

Affected codes include ILR insertion/removal and remote/in-person interrogation/programming (e.g., 33285, 33286, 93285, 93291, 93297, 93298, 0650T).
Include clinical documentation showing the specific guideline-based indication (see Guideline-Driven Rationale) and prior noninvasive monitoring results when applicable.

Prior Authorization

Prior Authorization — Guideline-Driven Rationale

Use guideline-driven rationale to support prior authorization requests. Documentation should reference relevant clinical practice guidelines and show that the requested ILR aligns with guideline indications (for example: cryptogenic stroke/ESUS with suspected paroxysmal AF, infrequent unexplained syncope after noninvasive workup, high-risk structural heart disease with suspected arrhythmia, or nondiagnostic noninvasive testing).

Background and Evidence Summary

Cardiac arrhythmias range from transient palpitations to clinically important, sometimes asymptomatic, episodes such as atrial fibrillation that increase stroke risk. Because arrhythmias can be infrequent or intermittent, ambulatory ECG monitoring is used to capture events that are not seen on an in-office ECG. Insertable cardiac monitors or implantable loop recorders (ILRs) are subcutaneous devices that provide long-term continuous rhythm surveillance and higher diagnostic yield when noninvasive monitoring is contraindicated or nondiagnostic after at least two weeks of monitoring. Societal guidance supports escalating from short-term ambulatory monitoring (24–72+ hours) to longer external monitors and to ILR when clinical suspicion remains and maximized sensitivity is required (for example, post-cryptogenic stroke or unexplained infrequent syncope).

Definitions

Cardiac Self-Monitoring Devices — consumer-grade connected devices/apps definition

DefinitionConsumer-grade, connected electronic devices and/or software applications that can be used without a physician's prescription to collect physiologic information (e.g., ECG, heart rate) and download it to personal devices for home use

ExamplesSmartphone or smartwatch ECG apps, wearable pulse/irregular rhythm notification applications, and associated hardware/software for downloading ECG data

Policy stanceDevices commercially available to the general public and purchased for home use are considered convenience items and are not medically necessary

Implantable Loop Recorder (ILR) — definition of subcutaneous continuous recorder

DefinitionA subcutaneous device placed under the skin that continuously records the heart's electrical activity and can transmit data to a physician to evaluate infrequent symptoms such as palpitations or syncope

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CSO92PA.U

Change TypeTitle and coverage language revisions

Effective DateJun 1, 2025

Next Review Date

Key ActionObtain prior authorization documenting medical necessity and prior noninvasive monitoring attempts (at least two weeks) before ILR insertion or replacement.

SourceLink

On This Page

High pre-test probability for arrhythmia in syncope: When there is a high pre-test probability of identifying an arrhythmia associated with syncope, ECG monitoring is indicated and an ILR may be useful if noninvasive testing is inconclusive.

Reflects ESC and HRS syncope guidance

Consumer wearable devices and notifications: Consumer wearable heart rhythm devices are widely used and can detect irregular rhythms, but validation, best-use strategies, and clinical integration remain to be defined; notifications from consumer devices generally require confirmatory diagnostic ECG monitoring before clinical decisions.

Summarizes societies' statements and concerns about accuracy and need for confirmation

Koh et al. 2021 randomized post-stroke/TIA participants to 30‑day smartphone ECG vs 24‑hour Holter and used 30‑second AF episodes as the primary detection endpoint

Implication for monitoringSingle‑lead smartphone ECGs in trials classified AF when episodes lasted 30 seconds or longer

When applicable, reference guideline recommendations that prolonged or implantable monitoring is reasonable after inconclusive external ambulatory monitoring.
For post-stroke AF evaluation, include stroke subtype (cryptogenic/ESUS), prior monitoring duration/results, and stroke-related risk factors.

Note

Prior Authorization and Administrative Tools

Prior authorization determinations are governed by the member's benefit plan provisions and may use administrative tools (including third-party criteria such as InterQual) to assist in benefit administration. Providers must follow required PA submission processes and include required documentation.

UnitedHealthcare may apply InterQual or other clinical criteria to assess requests.
Verify and follow the specific PA submission workflow for the member's plan; incomplete submissions may delay or result in denial.

Denial Risk

Requests for Consumer-Grade Wearable Cardiac Self-Monitoring Devices

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 may be denied when requested for coverage. These items are treated as convenience items due to insufficient evidence of efficacy.

Examples include smartwatch-based ECG apps and hardware/software required to download ECG data to personal devices.
If wearable-generated data triggers clinical evaluation, document the workflow and clinical follow-up (see Documentation Workflow for Wearable-Triggered Evaluation).

Note

Not Applicable / No Additional Payer Triggers in This Excerpt

Some content in this excerpt does not establish additional payer-specific prior authorization triggers beyond those stated; providers should rely on the policy's explicit PA requirements and member benefit provisions when submitting requests.

No separate step-therapy requirements are specified in this document fragment.
Follow the explicit clinical and documentation criteria described elsewhere in the policy when uncertain.

Documentation Required

Policy Change Impact

Policy updates may change coverage rules or administrative requirements. Providers must apply the current policy language and not rely on archived versions; use of prior rules may result in denial.

Effective date for this policy version: 2025-06-01; prior version CSO92PA.T is archived.
When submitting PA requests, ensure documentation reflects criteria in the current policy version.

Documentation Required

Documentation Should Support Noninvasive Monitoring Was Contraindicated or Nondiagnostic

Documentation for PA should support that noninvasive cardiac monitoring was contraindicated or yielded nondiagnostic results after an adequate duration (typically at least two weeks, and guideline-recommended durations such as up to four weeks for certain external monitors). If an ILR is requested without prior noninvasive monitoring, explain and document contraindication or inability to complete monitoring.

Document type(s) of prior monitoring used (Holter, patch, MCOT), monitoring duration, and results.
If noninvasive monitoring was not feasible, provide clear clinical justification (e.g., expected noncompliance, contraindication).

Documentation Required

Documentation Workflow for Wearable-Triggered Evaluation

When wearable device notifications lead to further clinical evaluation, include documentation of the workflow used for evaluation and follow-up (telemedicine visits, provision and return of ECG patches, analysis and clinician review), and the resulting clinical actions.

Document the date of wearable notification, method of clinical contact (e.g., telemedicine), and any external monitor dispatched (e.g., ePatch) including return and diagnostic yield.
Include clinician interpretation, subsequent management steps, and whether findings led to device implantation consideration.

Note

Check Benefit Plan Provisions

Before making coverage decisions, check the member's federal, state, or contractual benefit plan provisions. In the event of conflict between this Medical Policy and the member's specific plan terms, the plan governs.

Confirm any state-mandated benefits or contract-specific coverage rules that may affect PA requirements or coverage determination.
Document compliance with plan-specific submission requirements.

Prior Authorization

Recommended Monitoring Escalation and Noninvasive Extended Monitoring

Consider a stepwise monitoring approach: start with noninvasive short-term continuous ambulatory monitoring (e.g., Holter 24–48 hours, patch 7–14 days, MCOT up to 30 days) and escalate to an ILR when noninvasive monitoring is nondiagnostic or when extended monitoring is otherwise indicated per guidelines.

For individuals who can comply with daily ECG monitoring, MCOT may be effective for up to four weeks before considering ILR.
For infrequent symptoms (>30 days between events) or when prolonged monitoring is needed, ILR may be reasonable if noninvasive methods are nondiagnostic.

Step Therapy

No Step Therapy Specific Instructions in This Document

No step therapy-specific instructions are included in this document fragment. Providers should follow the member's benefit plan and any separate step therapy policies if applicable.

If a plan requires a specific noninvasive trial prior to ILR, adhere to that plan's step requirements when submitting PA.

PurposeLong‑term continuous rhythm monitoring to identify intermittent arrhythmias not captured on short‑term external monitors

Policy contextCovered when noninvasive monitoring is contraindicated or nondiagnostic after at least two weeks and other clinical indications are met

Mobile/consumer ECG and smartwatch monitoring — definition and trial usage

DefinitionSmartphone single‑lead ECG devices and smartwatch pulse/irregular rhythm notification applications used for intermittent or continuous rhythm surveillance (examples: KardiaMobile, Apple Watch applications)

Trial usageUsed in clinical studies for intermittent monitoring (e.g., thrice-daily smartphone ECG over 30 days in post‑stroke patients) and for large‑scale smartwatch notification screening (Apple Heart Study)

LimitationsStudies report unclassified or false‑positive readings; positive wearable notifications generally require confirmatory ECG monitoring

Insertable cardiac monitor (ICM) / ILR — definition for long-term monitoring when noninvasive testing is nondiagnostic

DefinitionAn implantable subcutaneous device (insertable cardiac monitor / ILR) intended for long‑term cardiac rhythm monitoring to detect intermittent arrhythmias when noninvasive testing is inconclusive or when high diagnostic sensitivity is required

Clinical roleUsed after nondiagnostic noninvasive evaluation (e.g., Holter, patch, event monitors) for suspected infrequent arrhythmias or syncope

Guideline supportRecommended by ACC/AHA/HRS and HRS/ISHNE guidance as reasonable when noninvasive modalities are nondiagnostic

Implantable Loop Recorder — updated definition noted in policy (specific text in source)

Updated policy wordingThe policy notes an updated definition of 'Implantable Loop Recorder' in the revision history (06/01/2025) reflecting current description of the device as a subcutaneous recorder that continuously records and transmits cardiac electrical activity

Revision noteDefinitions were updated in the policy revision; archived prior policy version CSO92PA.T

Practical implicationRefer to the updated policy definition when documenting indications and device descriptions for coverage determinations

Wearable Heart Rhythm Monitors / Cardiac Self-Monitoring Devices — policy states consumer wearables commercially available and for home use are not medically necessary

Policy positionWearable heart rhythm monitors or Cardiac Self‑Monitoring Devices commercially available to the general public and purchased for home use are not medically necessary

Examples includedECG monitors combined with a personal electronic device (phone or watch) and hardware/software for downloading ECG data to personal devices

ReasoningDeemed convenience items with insufficient evidence of efficacy for identifying arrhythmias and thus excluded from coverage