Medical Policy - Implantable Loop Recorders and Wearable Heart Rhythm Monitors

Coverage Summary

This policy defines medical necessity criteria for Implantable Loop Recorders (ILRs) and establishes the coverage stance for consumer-grade wearable cardiac self-monitoring devices for UnitedHealthcare Commercial and Individual Exchange plans. It outlines indications and replacement criteria for ILRs when noninvasive monitoring is contraindicated or nondiagnostic after at least two weeks and lists associated CPT/HCPCS codes and guideline-derived recommended uses.

Background: ILRs are subcutaneously implanted monitors that continuously record cardiac electrical activity and can transmit data for physician review; they are used when prolonged monitoring is needed to diagnose arrhythmias such as cryptogenic stroke or unexplained syncope. By contrast, consumer-grade wearable ECG devices (smartwatch/smartphone-based single-lead systems and related hardware/software) are widely available but regarded as convenience items and are not considered medically necessary because evidence is insufficient to demonstrate clinical efficacy and impact on patient outcomes.

Policy metadata

policy_number2026T0489II

effective_dateJanuary 1, 2026

last_review2026-01-01

statusCURRENT

policy_subjectImplantable Loop Recorders and Wearable Heart Rhythm Monitors

Medically Necessary Criteria

Not Medically Necessary - Consumer Cardiac Self-Monitoring Devices

Consumer-grade wearable ECG and mobile medical applications are considered convenience items and are not medically necessary due to insufficient evidence of efficacy and lack of demonstrated benefit on clinical outcomes; existing studies report high diagnostic accuracy in some settings but do not uniformly show improved patient health outcomes or adequate follow-up to confirm clinical utility.

Guidelines and Evidence (Informational)

Study / Source	Key finding
STROKE-AF trial (Bernstein et al. 2021)
ICM detected AF 12.1% vs 1.8% at 12 months; hazard ratio 7.4 (95% CI 2.6-21.3)
Jiang et al. meta-analysis (2022)
Pooled AF rate for ILRs rose from 4.9% at 1 month to 38.4% at 36 months; MCOT had higher AF detection at 1 month (12.8% vs 4.9%)
Svendsen et al. RCT (LOOP Study, 2021)
ILR increased AF detection (31.8% vs 12.2%) but no statistically significant reduction in stroke (HR 0.80; p=0.11) over median 64.5 months
Solbiati et al. systematic review (2017)
Overall diagnostic yield for unexplained syncope ~43.9%
Noubiap et al. systematic review/meta-analysis (2021)
Pooled ICM AF rates: 12.2% at 3 months, 16.0% at 6 months, 18.7% at 12 months, 22.8% at 24 months, 28.5% at 36 months; MCOT ~13.7% at 1 month
Da Costa et al. (2013) randomized study
ILR strategy superior to conventional follow-up for detecting relevant arrhythmias (36% vs 10.8% in BBB patients)

Cardiac Self-Monitoring Devices: consumer-grade connected devices and/or software applications that members can use without a physician's prescription to collect physiologic information (e.g., ECG) downloadable to personal devices.

Implantable Loop Recorder (ILR): a device placed under the skin that continuously records the heart's electrical activity and can transmit data to a physician for monitoring and diagnosis.

ILR/ICM: insertable cardiac monitor (ICM) — another term for an implantable loop recorder used for long-term subcutaneous cardiac rhythm monitoring.

Coding - CPT / HCPCS / Other

Implantable Loop Recorder - CPT / HCPCS / Othermixed

0650T	Programming device evaluation (remote) of subcutaneous cardiac rhythm monitor system, with iterative adjustment of the implantable device to test function and select optimal permanently programmed values with analysis, review and report
33285	Insertion, subcutaneous cardiac rhythm monitor, including programming
33286	Removal, subcutaneous cardiac rhythm monitor
93285	Programming device evaluation (in person) with iterative adjustment; subcutaneous cardiac rhythm monitor system
93291	Interrogation device evaluation (in person) with analysis, review and report; 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, analysis, review(s) and report(s)
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)
E0616	Implantable cardiac event recorder with memory, activator, and programmer (HCPCS)

No procedure or diagnosis codes provided in this partmixed

No codes listed

Cardiac Self-Monitoring Devices - CPT / HCPCS / OthermixedNot Covered

0902T	QTc interval derived by augmentative algorithmic analysis of input from an external, patient-activated mobile ECG device
93799	Unlisted cardiovascular service or procedure
E1399	Durable medical equipment, miscellaneous (HCPCS)

No procedure or diagnosis codes provided in this partmixed

No codes listed

Provider Actions & Billing Guidance

Documentation Required

Clinical documentation to support medical necessity

Medical records documentation may be required to assess whether the member meets the clinical criteria (for example, documentation that prior noninvasive cardiac event recording was performed for at least two weeks and the specific clinical circumstance prompting ILR consideration).

Document prior noninvasive monitoring duration (e.g., ≥ 2 weeks) when applicable
Document the specific clinical circumstance (cryptogenic stroke, unexplained syncope, suspected ventricular arrhythmia, high arrhythmia risk, abnormal testing)
Include records of modification of medications or prior diagnostic testing results

Billing Rule

Code use for ILR insertion/removal and device evaluation

Report the applicable CPT/HCPCS codes for ILR insertion, removal, programming, interrogation, and remote monitoring as appropriate.

Evidence Summary & Definitions

Evidence supporting ILRs includes randomized trials and meta-analyses showing substantially increased atrial fibrillation (AF) detection with long-term implantable monitoring versus shorter-term or usual-care monitoring. Key trials include STROKE-AF and PER DIEM, and meta-analyses (e.g., Jiang et al., Noubiap et al.) that demonstrate rising pooled AF detection rates over time (for ILRs, pooled AF rates increase with duration of monitoring).

However, several large RCTs (for example, the LOOP trial) and longer-term follow-up data have not consistently demonstrated that increased AF detection with ILRs translates into a statistically significant reduction in stroke or systemic embolism; the LOOP RCT showed a threefold increase in AF detection and anticoagulation initiation but did not show a significant reduction in stroke (HR 0.80; p=0.11). Thus, while ILRs have strong diagnostic yield, evidence of downstream clinical outcome benefit (stroke prevention) is mixed.

Evidence	Result
STROKE-AF trial (Bernstein et al. 2021)
ICM detected AF 12.1% vs 1.8% at 12 months; HR 7.4 (95% CI 2.6-21.3)
Jiang et al. meta-analysis (2022)
Pooled ILR AF rate increased from 4.9% at 1 month to 38.4% at 36 months; MCOT higher AF detection at 1 month
Svendsen et al. RCT (LOOP Study, 2021)
ILR increased AF detection (31.8% vs 12.2%) but did not significantly reduce stroke (HR 0.80; p=0.11)
Solbiati et al. systematic review (2017)
Diagnostic yield for unexplained syncope ~43.9%
Noubiap et al. systematic review/meta-analysis (2021)
Pooled ICM AF rates: 12.2% at 3 months to 28.5% at 36 months; MCOT ~13.7% at 1 month
Da Costa et al. (2013)
ILR detected relevant arrhythmias in 36% vs 10.8% with conventional follow-up in BBB patients

Cardiac Self-Monitoring Devices: consumer-grade devices and software used without a prescription to collect physiologic data (e.g., ECG) for download to personal devices.

Implantable Loop Recorder (ILR): a subcutaneous device that continuously records cardiac electrical activity and transmits data to clinicians for prolonged arrhythmia evaluation.

ILR/ICM: insertable cardiac monitor, synonymous with implantable loop recorder for long-term rhythm monitoring.

Revision History

2026-01-01template_updateLatest

01/01/2026, Summary of Changes = Template Update; document indicates a template update with no clinical policy statement changes.