ModifiedUnitedHealthcarePolicy CS092TN.W

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

Medical policy governing use and coverage of implantable loop recorders (ILRs) and wearable/cardiac self-monitoring devices for Tennessee Medicaid and CoverKids members.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS092TN.W

Change TypeMaterial removals and revisions to coverage, coding, and definitions

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionAttempt noninvasive monitoring for at least two weeks before considering ILR; obtain prior authorization when documentation supports guideline-based indications.

SourceLink

POLICY UPDATE CHANGES

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

Removed language indicating ambulatory event monitoring is proven and medically necessary for evaluating suspected cardiac arrhythmias.

Replaced prior language about consumer-available wearable heart rhythm monitors not being medically necessary with 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 multiple CPT codes related to ambulatory monitoring (e.g., 93224-93229, 93241-93248, 93268, 93270-93272).

Removed definitions for Ambulatory Event Monitoring/Electrocardiography (ECG), Attended Surveillance, and Outpatient Cardiac Telemetry; updated definition of 'Implantable Loop Recorder'.

≥2 weeksminimum noninvasive monitoring prior to ILR

28.5%

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Coverage Criteria — ILR and Wearable Monitoring

Implantable Loop Recorder — Initial Insertion

Covered when ALL of the following are met:

Initial ILR criteria: Noninvasive cardiac event recording is contraindicated OR noninvasive monitoring yielded non-diagnostic results after at least two weeks of monitoring>= 2 weeks of prior monitoring or contraindication

From policy coverage rationale

Clinical indications: One or more of: suspected paroxysmal atrial fibrillation in the setting of a cryptogenic stroke/systemic thromboembolism; suspected or known ventricular arrhythmia; high risk for arrhythmia due to structural/infiltrative heart disease or medications that cause malignant arrhythmias; recurrent or unexplained infrequent syncope after medication modification or associated with autonomic dysfunction; abnormal electrophysiology or tilt-table testing

Enumerated indications in policy

Replacement of ILR

Covered when ALL of the following are met:

Replacement criteria: Member continues to meet all initial insertion criteria AND existing device is beyond useful life, irreparable, or no longer operating

Policy states replacement is medically necessary under these conditions

Cardiac Self-Monitoring Devices (consumer-grade, wearable)

Policy stance:

Consumer devices not covered: 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

Policy lists examples (ECG-enabled watches, hardware/software for downloading ECG data)

Guideline-supported indications for extended monitoring / ILR

Covered when ALL of the following guideline-based scenarios are met (per cited society guidance):

cryptogenic stroke/TIA: Patient with ischemic stroke or TIA of undetermined cause where initial cardiac monitoring is inconclusive; extended monitoring or ILR is reasonable to detect occult AF.not applicable

Supported by ACC/AHA/HRS, AHA/ASA, ESC, ESO guidelines.

infrequent recurrent syncope: Patient with infrequent, recurrent unexplained syncope suspected to be arrhythmic after nondiagnostic initial evaluation; ILR is reasonable.symptom frequency often >30 days between events

Supported by ACC/AHA/HRS and consensus statements.

AF-induced cardiomyopathy surveillance: Patients with recovered LV function after AF-induced cardiomyopathy where long-term surveillance is desired to detect recurrent AF.

Consumer/mobile monitoring — evidence and coverage considerations

Coverage/consideration for consumer and smartphone-based monitoring:

diagnostic accuracy evidence: AI-based PPG and single-lead ECG technologies show high pooled sensitivity and specificity for AF detection in diagnostic studies, but proportion of unclassified tracings and false positives varies.PPG unclassified 0–43.2%; single-lead ECG unclassified 0–38%

Manetas-Stavrakakis meta-analysis; KardiaMobile and Apple Heart Study findings.

clinical utility evidence: Clinical utility of mobile medical applications (MMAs) is unclear with mixed evidence: some studies show increased detection but no consistent demonstration of improved clinical outcomes.not applicable

Hayes Evolving Evidence Review (2021, updated 2023) and RCTs.

confirmatory testing requirement: Device-detected irregularities should be confirmed with medical-grade ambulatory ECG (eg, patch or Holter) and clinical evaluation prior to initiating treatments like anticoagulation because studies reported false positives and substantial unclassified results.

Monitoring escalation and ILR consideration

Covered when monitoring follows guideline-recommended escalation and noninvasive monitoring has been insufficient to establish a diagnosis

Monitoring escalation before ILR: Short-term continuous ambulatory ECG monitoring (24 hours up to seven days) should be used first; if unsuccessful, intermittent external loop recording (weeks to months) is appropriate; for individuals remaining undiagnosed after prolonged noninvasive monitoring, ILR may be necessary.sequence

Reflects HRS/ISHNE and NICE guidance

NICE: ambulatory monitoring by symptom frequency

Use of ambulatory monitoring by symptom timing

Ambulatory ECG selection: Use 24-hour ambulatory ECG for suspected asymptomatic episodes or symptomatic episodes less than 24 hours apart; use ambulatory ECG monitor, event recorder, or other ECG technology for symptomatic episodes more than 24 hours apart.time_between_symptoms

Per NICE guideline

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 identifies these consumer‑grade devices — including ECG‑enabled phones or watches and the hardware or software required to download ECG data to personal devices — as convenience items because the available evidence does not demonstrate sufficient efficacy to support coverage.

Hayes’ Evolving Evidence Review (2021, updated 2023) found no clear evidence of clinical outcome benefit for mobile medical applications (MMAs) used to detect cardiac arrhythmias. Although some studies reported increased arrhythmia detection with MMAs versus routine care or Holter monitoring, the review concluded that available studies were generally small or had limited follow‑up and did not provide consistent demonstration of improved patient health outcomes.

Policy language was updated to clarify the scope of the exclusion: wearable heart rhythm monitors or Cardiac Self‑Monitoring Devices commercially available to the general public and purchased for home use are not medically necessary. This phrasing replaces prior wording and explicitly designates consumer‑grade wearable devices acquired for home use as not eligible for coverage.

Consumer‑grade cardiac self‑monitoring devices and their associated hardware/software are considered unproven and not medically necessary because the evidence is insufficient to establish clinical efficacy and meaningful patient outcome benefits. Reviews and trials have documented diagnostic accuracy in some settings but have not reliably shown that use of these consumer devices leads to improved clinical outcomes or appropriate downstream management without confirmatory medical‑grade testing.

Routine use of mobile medical applications or wearable devices for screening without confirmatory medical‑grade testing has unclear clinical utility. The Hayes review and large pragmatic studies noted higher detection rates but emphasized the need for confirmatory ambulatory ECG (eg, patch or Holter) and documented clinical follow‑up before initiating treatments such as anticoagulation, because false positives, unclassified recordings, and low rates of returned confirmatory monitors may limit validity and clinical actionability.

Accordingly, consumer‑grade wearable heart rhythm monitors purchased for home use are explicitly designated not medically necessary. Requests for these devices may be denied as convenience items since they lack sufficient evidence of safety and efficacy to support coverage under the policy.

Coding and Applicable Codes

Applicable CPT codesCPT

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.
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.

Referenced monitoring modalities (no explicit codes listed)mixed

No codes listed

Removed CPT CodesCPT

93224	removed
93225	removed
93226	removed
93227	removed
93228	removed
93229	removed
93241	removed
93242	removed
93243	removed
93244	removed

1–10 of 18

1/2

AF episode duration for detection (key facts)

AF episode duration for detection>= 30 seconds

Source study example (Koh et al., 2021)RCT compared 30-day smartphone ECG vs 24-hour Holter for AF >=30 seconds

Implication for device-detected eventsAF episodes >=30 seconds are the threshold used for detection and reporting in cited studies

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Verify Prior Authorization with Benefit Plan

Prior authorization requirements are governed by the member's benefit plan and applicable contractual requirements. Providers must verify prior authorization (PA) and benefits with the member's plan before scheduling ILR insertion, removal, programming, or extended monitoring services.

Prior authorization may be required for procedures and device services (e.g., CPT 33285, 33286, 93285, 93291, 93297, 93298; HCPCS E0616, E1399).
Inclusion of procedure or HCPCS codes in this policy does not guarantee coverage — verify benefits and any PA requirements with the payer.
In case of conflict between this policy and the member's federal, state, or contractual benefit terms, the benefit terms govern.

Documentation Required

Policy Use and Plan Benefit Verification

This policy is informational and assists in interpreting UnitedHealthcare standard benefit plans. Providers must confirm coverage, prior authorization requirements, and any limits or exclusions with the member's specific benefit plan and applicable federal or state mandates prior to providing services.

Definitions

Cardiac Self-Monitoring Devices — definition

DefinitionConsumer-grade, connected electronic devices and/or software applications that members can use without a physician's prescription to collect physiologic information (eg, ECG, heart rate) downloaded to personal devices

Form factorsWearable accessories or embedded into clothing; smartphone, smartwatch, tablet, or personal computer interfaces

CapabilitiesHigh processing power, multiple sensors, and algorithms that can generate measurements such as blood pressure, heart rate, and heart rhythm (ECG)

Implantable Loop Recorder — definition

DefinitionA subcutaneously placed device that continuously records the heart's electrical activity and can transmit data to the clinician to evaluate infrequent palpitations or syncope

Purpose

Background and Evidence Summary

Background: Cardiac arrhythmias may be symptomatic or asymptomatic, and the choice and duration of ambulatory ECG monitoring should be guided by symptom frequency and clinical context. Implantable Loop Recorders (ILRs) provide long‑term, continuous subcutaneous monitoring and are especially useful when arrhythmic events are infrequent or when prior noninvasive monitoring (typically at least 2 weeks) is contraindicated or nondiagnostic. Guideline‑based escalation of monitoring — beginning with short‑term ambulatory ECG or external monitors and progressing to ILR when noninvasive methods are inconclusive — helps match monitoring modality to the expected event frequency and diagnostic need.

Revision History and Policy Changes

2025-06-01Title change and coverage rationale revisedLatest

Policy title changed from 'Cardiac Event Monitoring (for Tennessee Only)' to 'Implantable Loop Recorders and Wearable Heart Rhythm Monitors (for Tennessee Only)', and language stating ambulatory event monitoring was proven and medically necessary was removed.

Consumer device scope clarified

Replaced prior phrasing with explicit statement 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.