UnitedHealthcare Implantable Loop Recorder Coverage Update

Coverage Criteria for ILRs and Consumer Cardiac Devices

Initial insertion — medically necessary

Covered when ALL of the following are met

Initial ILR criteria: 1) Individual is ≥ 18 years of age; 2) Noninvasive cardiac event recording is contraindicated or has yielded nondiagnostic results after at least 2 weeks of monitoring; AND 3) One or more of the following indications: suspected paroxysmal atrial fibrillation in the setting of cryptogenic stroke or other systemic thromboembolism; suspected or known ventricular arrhythmia; high risk for arrhythmia due to structural or infiltrative heart disease (eg, aortic stenosis, hypertrophic cardiomyopathy, cardiac sarcoidosis, congenital heart disease, family history, dilated ischemic or nonischemic cardiomyopathy) or use of QT-prolonging medications; recurrent or unexplained infrequent syncope after modification of potentially syncope-causing medications or when associated with autonomic dysfunction; post-cavotricuspid isthmus (CTI) ablation for typical atrial flutter if the individual is not on long-term anticoagulation and is at high thromboembolic risk (eg, CHA2DS2-VASc ≥ 2 or HATCH ≥ 2); atrial fibrillation detected during an acute medical illness or following surgery, particularly after noncardiac procedures in individuals with stroke risk factors; or abnormal diagnostic tests such as electrophysiology study or tilt table testing.

From Coverage Rationale

Replacement of ILR — medically necessary

Covered when ALL of the following are met

Replacement criteria: Individual continues to meet all initial insertion criteria and the existing implantable loop recorder is beyond its useful lifespan, irreparable, or no longer operating.

From Coverage Rationale

Cardiac self-monitoring devices — not medically necessary

Consumer device exclusion: Wearable heart rhythm monitors and cardiac self-monitoring devices commercially available to the general public and purchased for home use (including devices integrated with personal electronics and hardware/software required for downloading ECG data) are considered convenience items, are unproven, and are not medically necessary for arrhythmia detection or management.

From Coverage Rationale

Guideline-based ILR indications

Covered when guideline-recommended indications are met (per ACC/AHA/HRS and AHA/ASA statements):

Indications: - Cryptogenic stroke or TIA where detection of AF would alter management: consider prolonged monitoring (preferably ≥14 days) or an implantable cardiac monitor in selected high-risk patients. - Unexplained or recurrent syncope with nondiagnostic initial workup and infrequent symptoms (eg, >30 days between events): long-term ambulatory monitoring with an ICM/ILR is reasonable. - Suspected intermittent ventricular arrhythmias or high suspicion for arrhythmic cause when noninvasive monitoring was nondiagnostic: consider ILR. - Patients with typical atrial flutter after CTI ablation who are at high thromboembolic risk and not receiving ongoing anticoagulation: close follow-up and arrhythmia monitoring to detect silent AF. - AF identified during acute medical illness or surgery: outpatient follow-up for thromboembolic risk stratification and AF surveillance is reasonable.

Guideline-based recommendations; documentation of prior noninvasive testing and symptom frequency may be required.

Consumer wearable devices — not medically necessary / informational

Coverage stance for consumer/self-monitoring devices:

Consumer device stance: - Cardiac self-monitoring devices and software applications that download ECG data to personal consumer devices are considered convenience items and are unproven and not medically necessary due to lack of quality research demonstrating safety and efficacy. - Although some studies and meta-analyses report high sensitivity and specificity for AF detection in selected settings (eg, smartwatch single-lead ECG or PPG algorithms), limitations include motion artifacts, unclassified tracings, variable algorithm versions, and limited evidence of improved clinical outcomes. - Large pragmatic studies (eg, Apple Heart Study) demonstrated low notification rates with subsequent downstream clinical actions in some participants, but generalizability and outcome impact remain uncertain.

Consumer/self-monitoring devices are informational and typically excluded from coverage; medical-grade confirmation is required for clinical decision-making.

Guideline-aligned coverage criteria

Covered when monitoring is indicated by guideline-recommended clinical scenarios and when appropriate prior evaluation/shorter-term monitoring has been performed:

HCM initial and follow-up monitoring: Patients with hypertrophic cardiomyopathy (HCM): ambulatory ECG monitoring (typically 24–48 hours) is recommended at initial evaluation and periodically (eg, every 1–2 years); extended monitoring (>24 hours) for palpitations/lightheadedness and extended monitoring to screen for AF in high-risk patients when anticoagulation eligibility exists.see durations

AHA/ACC guidance

Cryptogenic/embolic stroke monitoring: Patients with cryptogenic or embolic-appearing stroke/TIA: prolonged rhythm monitoring (external extended monitors, MCOT, or ILR) is reasonable to detect occult AF when no other cause is identified and when anticoagulation is not contraindicated.consider long-term monitoring or ILR

AHA/ASA, ESO, NICE

Unexplained syncope:

Proven and medically necessary indications (revised)

Covered when ALL of the following are met (as revised):

General ILR coverage: Noninvasive cardiac event recording is contraindicated or has yielded nondiagnostic results after at least 2 weeks of monitoring.>= 2 weeks

From policy revisions

Added specific covered indications: Post-cavotricuspid isthmus ablation for typical atrial flutter in individuals who are not on long-term anticoagulation and are at high thromboembolic risk (eg, CHA2DS2-VASc ≥ 2 or HATCH ≥ 2), OR atrial fibrillation detected during an acute medical illness or following surgery (particularly after noncardiac procedures) in individuals with stroke risk factors.CHA2DS2-VASc >= 2 or HATCH >= 2

Newly added scenarios per policy revision

This policy applies to UnitedHealthcare members aged 18 years and older; it does not apply to individuals < 18 years of age. Implantable loop recorders (ILRs) are considered when noninvasive cardiac event recording is contraindicated or has been nondiagnostic after at least 2 weeks of monitoring and when one or more guideline‑supported clinical indications are present (for example, cryptogenic stroke evaluation, unexplained infrequent syncope, suspected ventricular arrhythmia, or select post‑ablation and acute‑illness scenarios). Consumer‑grade cardiac self‑monitoring devices available to the general public are addressed separately and are not covered as medically necessary diagnostic substitutes for clinician‑directed monitoring.

Cardiac self‑monitoring devices sold directly to consumers (including wearable single‑lead ECG devices, fitness bands, smartwatches, and the hardware or software used to download ECG data to personal computers, tablets, or smartphones) are classified as convenience items. These consumer devices and associated download components are considered not medically necessary for the detection or diagnosis of arrhythmias because evidence of clinical benefit and sufficient diagnostic reliability in routine care is lacking.

FDA marketing authorization or clearance for a device is provided for informational purposes only; FDA approval alone is not a basis for coverage. Coverage determinations are made by the payer based on clinical evidence, guideline recommendations, and the policy criteria rather than regulatory status alone.

This policy explicitly excludes individuals younger than 18 years: it applies only to members who are age 18 and older. Pediatric indications for implantable cardiac monitors or consumer devices are outside the scope of this document.

Wearable heart rhythm monitors and cardiac self‑monitoring devices that are commercially available for home use (including devices integrated with phones or watches and related download hardware or software) are considered not medically necessary. These consumer‑facing products are intended for personal convenience and self‑monitoring and are not substitutes for medically indicated, clinician‑directed ambulatory ECG testing when diagnosing or managing arrhythmias.

Cardiac self‑monitoring smartphone or smartwatch applications and devices that download ECG or photoplethysmography data to an individual's personal consumer device are considered unproven for use as standalone clinical diagnostic tools and are not medically necessary. While some algorithms and devices demonstrate diagnostic accuracy for atrial fibrillation in selected studies, their routine use to guide clinical decision‑making without confirmatory medical‑grade testing is not supported by sufficient evidence.

Ambulatory ECG monitoring should be selected and its duration matched to the clinical context and symptom frequency. Routine or indiscriminate use of consumer fitness bands or smartwatches for ECG screening is discouraged; ambulatory monitoring is generally indicated when the pretest probability of an arrhythmic cause is high. When symptoms are infrequent or prolonged surveillance is required, stepwise escalation from short‑term monitors (eg, 24–48 hour Holter, 7–14 day patch) to extended external monitoring or ILR should be guided by clinical judgment and guideline recommendations.

CPT code 93799 (unlisted cardiovascular service or procedure) has been removed from the list of applicable codes for these services. Providers should not rely on CPT 93799 when submitting claims for implantable loop recorder or consumer cardiac self‑monitoring services.

Applicable Codes and Monitoring Durations

Applicable CPT and monitoring codesCPT

0902T	QTc interval derived by augmentative algorithmic analysis of input from an external, patient-activated mobile ECG device.
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.
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.

Applicable HCPCS CodesHCPCS

E1399	Durable medical equipment, miscellaneous (used for cardiac self-monitoring devices).
E0616	Implantable cardiac event recorder with memory, activator, and programmer.

FDA product codes (informational)mixed

Product codes DSI, MXD, DXH	Ambulatory electrocardiography devices, cardiac telemetry, or implantable loop recorders (FDA product codes reference).
Product codes DXH, DPS, QDA	Mobile cardiac self-monitoring devices (FDA product codes reference).

Removed/No longer applicable CPT codesCPTNot Covered

93799

Unlisted cardiovascular service or procedure (removed from applicable codes).

Noninvasive monitoring duration before ILR

Noninvasive monitoring trialNoninvasive cardiac event recording should be attempted for at least 2 weeks and be nondiagnostic before ILR insertion is considered.

Age applicabilityPolicy does not apply to individuals younger than 18 years of age.

Documentation implicationRequests may be denied if a ≥2‑week noninvasive monitoring trial was not attempted or documented as nondiagnostic.

Recommended monitoring durations

Holter monitorHolter ambulatory ECG: typically 24–48 hours.

Prior Authorization, Documentation, and Billing Instructions

Prior Authorization

Prior Authorization Required and Documentation Expectations

Prior authorization is required for insertion, removal, programming/interrogation, and remote monitoring of implantable loop recorders (ILRs). Requests must include clinical justification and documentation of prior noninvasive monitoring attempts when applicable. Coverage decisions are not based solely on FDA approval; FDA status is informational only.

Prior authorization required for codes: 33285, 33286, 93285, 93291, 93297, 93298, 0650T, 0902T, HCPCS E0616, E1399

Documentation Required

Clinical Justification and Prior Monitoring Documentation

Providers should document the clinical indication for ILR placement, prior workup, and results of any noninvasive monitoring. For cryptogenic stroke/TIA or suspected paroxysmal AF, documentation should note duration and modality of prior ambulatory monitoring (e.g., Holter, patch, MCOT), reason for nondiagnostic results, and symptom frequency.

Document prior noninvasive monitoring ≥ 2 weeks unless contraindicated

Background and Rationale

Cardiac arrhythmias range from asymptomatic or intermittent rhythm disturbances to sustained, symptomatic episodes that can cause syncope, stroke, or sudden cardiac arrest. Ambulatory electrocardiographic monitoring should be chosen based on the frequency and nature of symptoms: short‑duration continuous monitors (eg, Holter for <48 hours) are appropriate for frequent symptoms, intermediate‑duration external monitors (eg, patch monitors or mobile cardiac outpatient telemetry for days to weeks) suit less frequent events, and implantable loop recorders (ILRs) provide prolonged, continuous surveillance for infrequent or unexplained events. ILRs increase the diagnostic yield for infrequent syncope and occult atrial fibrillation compared with conventional short‑term monitoring because they continuously record rhythm for months to years and can transmit data to clinicians for detection of rare or asymptomatic arrhythmias that shorter monitors may miss.

Definitions

Cardiac Self‑Monitoring Devices — definition

DefinitionConsumer‑grade connected devices and/or software applications used without a physician's prescription to collect physiologic data (eg, heart rate, rhythm) and download to a personal smartphone, smartwatch, computer, or tablet.

Use caseDesigned for consumer self‑monitoring and convenience rather than as primary diagnostic medical devices.

Coverage stanceThese devices are considered not medically necessary for arrhythmia detection and are treated as convenience items.

Implantable Loop Recorder — definition

Device typeA subcutaneous device placed under the skin that continuously records the heart's electrical activity and can transmit data to clinicians for evaluation of infrequent palpitations or syncope.

Purpose

Policy Revision History

2026-05-01Policy revision (material)Latest

Policy updated to note it does not apply to individuals under 18 and to revise medically necessary indications for implantable loop recorders, adding post‑cavotricuspid isthmus ablation for typical atrial flutter in high thromboembolic risk individuals and AF detected during acute illness or after surgery (examples: CHA2DS2‑VASc ≥ 2 or HATCH ≥ 2).

2026-05-01Coding update

CPT code 93799 removed from the Applicable Codes list (no longer to be used for these services).

2026-05-01Supporting information update

OpenPayer

Implantable Loop Recorders and Wearable Heart Rhythm Monitors

Coverage Criteria for ILRs and Consumer Cardiac Devices

Applicable Codes and Monitoring Durations

Prior Authorization, Documentation, and Billing Instructions

Background and Rationale

Definitions

Policy Revision History