Humana Ambulatory Cardiac Monitoring Devices Form

Description

Inpatient cardiac monitoring is not addressed in this medical coverage policy.

Ambulatory cardiac monitoring devices are used by an individual at home to detect and/or manage cardiac arrhythmias and conditions such as cryptogenic (no identifiable cause) stroke. Various devices may be used for monitoring, including, but may not be limited, to continuous recorders (also known as Holter monitors), external loop monitors/recorders (also known as cardiac event monitors/recorders), implantable (insertable) loop monitors/recorders or mobile cardiac outpatient telemetry (also known as real time cardiac monitoring).

Holter and Long-Term Continuous Cardiac Rhythm Monitors/Recorders

The most common cardiac monitoring device is the Holter monitor (also known as a continuous recorder). Holter monitors are battery operated portable devices that continuously record the electrical activity of the heart, via leads attached to the chest, during activities of daily living (ADL). A healthcare provider then analyzes the recording to identify arrhythmias. Holter monitors are usually worn for 24 to 48 hours to correlate frequent (daily or more often) symptoms with recordings of symptomatic rhythm events. Other uses include, but may not be limited, to detection of asymptomatic events (eg, nonsustained ventricular tachycardia [NSVT]) for risk stratification of hypertrophic cardiomyopathy or functional assessment of a pacemaker or implantable cardioverter defibrillator (ICD).

Newer versions of rhythm monitors, including patch recorders, may be worn for long-term continuous cardiac rhythm monitoring (up to 14 days) to detect arrhythmias that occur less frequently (less than daily). Patch recorders that adhere to the external chest wall without leads or wires continuously record and store rhythm data for 7 – 14 days. The choice of Holter or long-term continuous monitoring device is predicated on the frequency of symptoms or suspected arrhythmia and the degree to which symptoms incapacitate the individual.

Examples of long-term continuous cardiac rhythm monitors include, but may not be limited to, Cardea Solo, Carnation Ambulatory Monitor (CAM patch) and Zio XT. The CAM patch is the only long-term monitor that is intended for children weighing at least 22 pounds or adults, while the Cardea Solo and Zio XT are indicated only for adults.

External Loop Monitors/Recorders (Cardiac Event Monitors/Recorders)

External loop monitors are battery operated portable devices that record the electrical activity of the heart during ADL and are worn continuously for up to 30 days. The individual starts the recorder when symptoms begin and turns it off when symptoms end. The device captures and saves a brief period of heart rhythm activity before and after activation. After the individual activates the device, the recording can be transmitted telephonically to a 24-hour attended monitoring center for remote technician review. If the electrocardiogram (ECG) recording is outside preset criteria, a healthcare provider reviews the data and makes individualized clinical decisions. Examples of these devices include, but may not be limited, to Heart 2005A, Heart 2006 and wEvent. In other instances, transmitted ECG data is reviewed later and are considered nonattended.

Implantable (Insertable) Loop Monitors/Recorders

Implantable (insertable) loop recorders are placed directly under the skin in the chest using a local anesthetic.

Electrodes in the device sense the heart’s activity, so Ambulatory Cardiac Monitoring Devices with an Effective Date of 06/22/2023 have no need for external electrodes or leads. When symptoms occur, the individual activates the ECG data recording for analysis by a healthcare provider. The device also has an auto-activation mode to automatically capture and record arrhythmias.

Most recorders can record and store at least 30 minutes of ECG signals during an episode of an arrhythmia. The device is removed when the battery fails, or earlier, if a definitive diagnosis has been established. Examples of these devices with an estimated battery life of 3 years include, but may not be limited to, Confirm Rx, Jot Dx, LUX-Dx, Reveal LINQ and Reveal XT implantable cardiac monitor systems. More recently developed versions of this device have a longer battery life and can be used to monitor and record heart rhythm and rate for 4 or more years. Examples include, but may not be limited to, Biomonitor IIIm and LINQ II implantable cardiac recorders. The LINQ II FDA-approved indications were recently expanded to include an individual 2 years of age or older.

Intracardiac Ischemia Detection Devices

The Guardian System is an implantable cardiac device suggested to measure ST elevation changes and possible impending myocardial infarction (heart attack) via real-time ECG. The system includes an intracardiac ischemia detection device, approximately the size of a pacemaker, with a lead placed into the heart, a pager/alerting device and a programming device that monitors the electrical activity of the heart. A healthcare provider programs the device to recognize specific changes in the heart signals which when detected sends a signal to the pager to alert the individual to seek immediate medical attention. Information from the device can be retrieved for analysis by a healthcare provider. (Refer to Coverage Limitations section)

Mobile Cardiac Outpatient Telemetry (Real-Time Cardiac Monitoring)

Mobile cardiac outpatient telemetry (MCOT) records, monitors and transmits an individual’s ECG continuously as they go about their normal ADL. A 3-lead sensor transmits each heartbeat to a cellphone sized monitor. If the monitor detects an arrhythmia, it transmits the individual’s ECG to the monitoring center using wireless or telephone landline communication technology depending on the individual’s location.

Certified cardiovascular technicians analyze the transmissions 24 hours a day. The prescribing healthcare provider selects individualized monitoring thresholds and response parameters. Routine daily telemetry reports are issued to the healthcare provider by email, fax, internet or phone. Examples of MCOT devices include, but may not be limited to, BodyGuardian Mini, LifeWatch MCT 3 Lead, MoMe ARC and Zio AT.

The BioFlux monitors and analyzes ECG data in real time using an ECG algorithm to detect and automatically transmit arrhythmia data to the monitoring center for review. The individual can also activate the device in the presence of any abnormal symptoms.

The recorded cardiac activity delivers via smartphone to the server where it is reviewed by a cardiovascular technician and escalated to a healthcare provider when predetermined parameters are met. The Rhythm Express RX-1, RhythmStar and the TeleSense 4-in-1 remote cardiac rhythm monitor each function as an external use Holter monitor, event monitor and MCOT depending on the needs of the individual and modality that is ordered by the healthcare provider.

Mobile Patient Management Systems

Mobile patient management systems are monitoring devices designed for detection of cardiac arrhythmias and vital signs. These devices differ from other ECG devices as they may also monitor activity, body fluid status, body temperature, posture and respiratory rate. Examples of such devices are VitalPatch RTM and Vitls/Tego. (Refer to Coverage Limitations section)

Self-Monitoring ECG Technologies

Self-monitoring ECG technologies, which may be obtained without a prescription, are generally activated by the touch of the individual's fingers to record and transmit data via a smartphone or watch. These wired or wireless devices are reported to monitor ECG, heart rate and other noncardiac indications and include, but may not be limited, to KardiaMobile Card or Verily Study watch. (Refer to Coverage Limitations section)

Electrocardiograph software for over-the-counter use creates, analyzes and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias, such as atrial fibrillation, bradycardia or tachycardia. These devices areAmbulatory Cardiac Monitoring Devices Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 03/23/2023 Policy Number: HUM-0435-032 Page: 5 of 28Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.not intended to provide a diagnosis. The Apple Watch and Fitbit Sense are examples of devices that use this technology. Other types of over-the-counter software and related devices are suggested to monitor oxygen saturation, respiratory rate and other body functions. (Refer to Coverage Limitations section)

Coverage Determination

Commercial Plan members: requests for repeat studies with like devices within 1 year of the previous study require review by a medical director.

The Rhythm Express RX-1, RhythmStar, TeleSense 4-in-1 and similar multi-function monitors are intended for single modality use (Holter OR event recorder OR MCOT modality).

Holter Monitors (93224-93227)

Humana members may be eligible under the Plan for Holter monitoring when testing will be completed within 24 to 48 hours AND for any of the following indications:

• Assessment of efficacy of medications for arrhythmia treatment; OR
• Assessment of the function of a pacemaker or implantable cardioverter defibrillator; OR
• Evaluation of cardiac rhythm following surgical or catheter ablation for atrial fibrillation (AF); OR
• Frequent (at least once every 24 to 48 hours) episodes of syncope, near-syncope or episodic dizziness without clinical explanation; OR
• Hypertrophic or dilated cardiomyopathy; OR
• Palpitations; OR
• Suspected cardiac arrhythmias; OR
• Suspected variant angina; OR

Ambulatory Cardiac Monitoring Devices Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 03/23/2023 Policy Number: HUM-0435-032 Page: 6 of 28Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Pediatric individual with any of the following indications:
  1. Assessment of efficacy of medications for arrhythmia treatment; OR
  2. Asymptomatic congenital complete atrioventricular (AV) block; OR
  3. Evaluation of cardiac rhythm after transient AV block associated with heart surgery or catheter ablation; OR
  4. Evaluation of possible or documented long QT syndrome; OR
  5. Evaluation of rate-responsive or physiological pacing function in a symptomatic individual; OR
  6. Hypertrophic or dilated cardiomyopathy; OR
  7. Palpitations with prior surgery for congenital heart disease and significant residual hemodynamic abnormalities (eg, bradycardia, hypotension); OR
  8. Syncope, near-syncope or dizziness with documented cardiac disease, previously documented arrhythmia or pacemaker dependency; OR
  9. Syncope, near-syncope or sustained palpitations in the absence of a reasonable explanation and where there is no overt clinical evidence of heart disease; OR
  10. Syncope or near-syncope associated with exertion when the cause is not established by other methods

Holter monitoring is generally considered medically necessary no more frequently than twice in a 6 month time period.

Long-Term Continuous Cardiac Rhythm Monitors (93241-93248)

Humana members may be eligible under the Plan for long-term continuous cardiac rhythm monitors when the following criteria are met:

• Diagnostic alternative to Holter monitoring when symptoms (eg, syncope, near syncope and/or palpitations) suggestive of a cardiac arrhythmia are infrequent (occur less frequently than once every 48 hours) or unpredictable and require prolonged testing; OR
• Evaluation of suspected atrial fibrillation following cryptogenic stroke when the results will be used to guide medical management (eg, anticoagulants); OR
• Monitoring within the last 60 days, using either a Holter monitor or hospital telemetry, fails to establish a definite diagnosis because symptoms (eg, syncope, near syncope and/or palpitations) are infrequent (occur less frequently than once every 48 hours) or unpredictable and require prolonged testing; AND
• Not utilized in the presence of an external cardiac defibrillator, pacemaker or neurostimulator; AND
• Individual is either:
  • 18 years of age or older for the Cardea Solo or Zio XT; OR
  • Greater than or equal to 22 lbs (10 kg) for the Carnation Ambulatory Monitor (CAM Patch)

Long-term continuous cardiac rhythm monitoring is generally considered medically necessary no more frequently than twice in a 6 month time period.

External Loop Monitors/Recorders (Cardiac Event Monitors) (93268, 93270-93272)

Humana members may be eligible under the Plan for external loop monitors with 24-hour attended monitoring when the following criteria are met:

• Diagnostic alternative to a Holter monitor when symptoms (eg, syncope, near syncope and/or palpitations) suggestive of a cardiac arrhythmia are infrequent (occur less frequently than once every 48 hours) or unpredictable; OR
• Evaluation of Holter monitor results that fail to document a suspected cardiac arrhythmia (eg, suspected AF as cause of cryptogenic stroke)

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

External loop monitoring is generally considered medically necessary no more frequently than once in a 6 month time period.

Implantable (Insertable) Loop Monitors/Recorders (0650T, 33285, 33286, 93285, 93291, 93298, C1764, E0616)

Humana members may be eligible under the Plan for implantable (insertable) loop monitors/recorders when the following criteria are met:

• Evaluation of syncope, near-syncope or palpitations;
  AND either of the following:
• Individual with clinical syndromes or situations that increase the risk of cardiac arrhythmias or transient symptoms that suggest a cardiac arrhythmia requiring prolonged testing (eg, suspected AF as cause of cryptogenic stroke); OR
• Noninvasive ambulatory monitoring fails to establish a definite diagnosis because symptoms are infrequent (occur less frequently than once every 48 hours) or unpredictable, and therefore prolonged testing is necessary

Replacement of implantable (insertable) loop monitors/recorders: An individual with an existing implantable (insertable) loop monitor/recorder (ILR) may receive an ILR replacement due to the end of battery life or device malfunction.

Mobile Cardiac Outpatient Telemetry (Real-time Cardiac Monitors) (93228, 93229)

Humana members may be eligible under the Plan for noninvasive mobile cardiac outpatient telemetry (MCOT)/real-time continuous attended cardiac monitor when the following criteria are met:

• Nondiagnostic monitoring (eg, Holter, long-term cardiac monitor [eg, patch monitor] or hospital telemetry) within 60 days prior to consideration of the use of MCOT fails to establish a definite diagnosis because symptoms (eg, syncope, near syncope or palpitations) are infrequent (occur less frequently than once every 48 hours) or unpredictable and therefore requires prolonged testing

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Noninvasive MCOT/real-time continuous attended cardiac monitoring is generally considered medically necessary no more frequently than once in a 6 month time period.

Note: The criteria for cardiac monitoring devices are not consistent with the Medicare National Coverage Policy, and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Coverage Limitations

Humana members may NOT be eligible under the Plan for Holter monitors, external loop monitors/recorders, implantable (insertable) loop monitors/recorders, long-term continuous cardiac rhythm monitors or real-time cardiac monitors/MCOT for any indications other than those listed above.

These are considered experimental/ investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Monitoring features/devices, stand-alone or integrated are considered integral to the primary device and not separately reimbursable.

Humana members may NOT be eligible under the Plan for the following cardiac monitoring devices:

• External loop monitors/recorders without 24-hour attended monitoring (93799); OR
• Intracardiac ischemia monitoring devices (eg, Guardian System) (0525T-0532T, C1833, G2066); OR
• Mobile patient management systems (eg, VitalPatch, Vitls/Tego) (93225, 93246, 99453, 99454, 99457, 99458)

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may NOT be eligible under the Plan for self-monitoring or over-the-counter ECG technologies for any indication. Although they may be prescribed by a health care practitioner, self-monitoring or over-the-counter (OTC) ECG technologies are also available without a prescription and may be obtained over the counter (OTC) and are therefore generally excluded in the certificate. In the absence of a certificate exclusion for OTC items, self-monitoring or OTC ECG technologies are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Additional information about heart disease may be found from the following websites:

Background

• American Heart Association
• National Library of Medicine

Medical Alternatives

Alternatives to ambulatory cardiac monitoring devices include, but may not be limited to:

• Inpatient cardiac telemetry

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.

Provider Claims Codes

Ambulatory Cardiac Monitoring Devices Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 03/23/2023 Policy Number: HUM-0435-032 Page: 11 of 28

Ambulatory Cardiac Monitoring Devices Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 03/23/2023 Policy Number: HUM-0435-032 Page: 13 of 28Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

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; implantable cardiovascular physiologic monitor system, including analysis of 1 or more recorded physiologic cardiovascular data elements from all internal and external sensorsAmbulatory Cardiac Monitoring Devices Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 03/23/2023 Policy Number: HUM-0435-032 Page: 14 of 28Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Ambulatory Cardiac Monitoring Devices Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 03/23/2023 Policy Number: HUM-0435-032 Page: 15 of 28Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Ambulatory Cardiac Monitoring Devices Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 03/23/2023 Policy Number: HUM-0435-032 Page: 16 of 28

Ambulatory Cardiac Monitoring Devices Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 03/23/2023 Policy Number: HUM-0435-032 Page: 17 of 28Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

References

• Agency for Healthcare Research and Quality (AHRQ). Technology Assessment (ARCHIVED). Remote cardiac monitoring. https://www.ahrq.gov. Published December 12, 2007. Accessed February 21, 2023.
• American Academy of Neurology (AAN). Summary of evidence-based guideline update: prevention of stroke in nonvalvular atrial fibrillation. https://www.aan.com. Published April 22, 2014. Updated October 22, 2022. Accessed May 25, 2023.
• American College of Cardiology (ACC). 2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities. https://www.acc.org. Published January 22, 2013. Accessed May 31, 2023.
• American College of Cardiology (ACC). 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation. https://www.acc.org. Published December 2014. Accessed May 31, 2023.
• American College of Cardiology (ACC). 2015 ACC/AHA/HRS guideline for the management of adult patients with supraventricular tachycardia. https://www.acc.org. Published April 5, 2016. Accessed May 31, 2023.
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• American College of Cardiology (ACC). 2017 AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. https://www.acc.org. Published October 2, 2018. Accessed May 31, 2023.
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• American College of Cardiology (ACC). 2018 AHA/ACC guideline for the management of adults with congenital heart disease. https://www.acc.org. Published April 2, 2019. Accessed May 31, 2023.
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• American Heart Association (AHA). AHA/ASA Scientific Statement. Prevention of stroke in patients with silent cerebrovascular disease. https://www.heart.org. Published February 2017. Accessed February 27, 2023.
• American Heart Association (AHA). AHA Policy Statement. Recommendations for the implementation of telehealth in cardiovascular and stroke care. https://www.heart.org. Published December 2016. Accessed February 27, 2023.
• American Heart Association (AHA). AHA Scientific Statement. Cardiac amyloidosis: evolving diagnosis and management. https://www.heart.org. Published July 7, 2020. Accessed February 27, 2023.
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• Bardy Diagnostics. Carnation Ambulatory Monitor (CAM) instructions for use. https://www.bardydx.com. Published August 2020. Accessed February 28, 2023.
• Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Electrocardiographic services (20.15). https://www.cms.gov. Published August 26, 2004. Accessed February 27, 2023.
• ClinicalKey. Calkins H, Everett TH, Chen PS. Hypotension and syncope. In: Libby P, Bonow RO, Mann DL, Tomaselli GF, Bhatt DL, Solomon SD. Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine. 12th ed. Elsevier; 2022:1387-1397. https://www.clinicalkey.com. Accessed February 21, 2023.
• ClinicalKey. Curtis AB, Tomaselli GF. Approach to the patient with cardiac arrhythmias. In: Libby P, Bonow RO, Mann DL, Tomaselli GF, Bhatt DL, Solomon SD. Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine. 12th ed. Elsevier; 2022:1145-1162.e7. https://www.clinicalkey.com. Accessed February 21, 2023.

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• Goldberger AL, Goldberger ZD, Shvilkin A. ECG leads. In: Goldberger AL, Goldberger ZD, Shvilkin A. Goldberger’s Clinical Electrocardiography. 9th ed. Elsevier; 2018:21-31. https://www.clinicalkey.com. Accessed February 21, 2023.
• ClinicalKey. Goldberger JJ, Albert CM, Myerburg RJ. Cardiac arrest and sudden cardiac death. In: Libby P, Bonow RO, Mann DL, Tomaselli GF, Bhatt DL, Solomon SD. Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine. 12th ed. Elsevier; 2022:1349-1386. https://www.clinicalkey.com. Accessed February 21, 2023.
• ClinicalKey. Krahn AD, Yee R, Skanes AC, Klein GJ. Electrocardiographic monitoring: short- and long-term recording. In: Zipes DP, Jalife J. Cardiac Electrophysiology: From Cell to Bedside. 8th ed. Elsevier; 2022:708-715. https://www.clinicalkey.com. Accessed February 21, 2023.
• ClinicalKey. Olgin JE. Approach to the patient with suspected arrhythmia. In: Golman L, Schafer AI. Goldman-Cecil Medicine. 26th ed. Elsevier; 2018:318-326.e2. https://www.clinicalkey.com. Accessed February 21, 2023.
• ClinicalKey. Richardson TD, Stevenson WG. Assessment of the patient with a cardiac arrhythmia. In: Jalife J, Stevenson WG. Zipes and Jalife’s Cardiac Electrophysiology: From Cell to Bedside. 8th ed. Elsevier; 2022:693-699. https://www.clinicalkey.com. Accessed February 21, 2023.
• ClinicalKey. Turahkia MP. Wearable devices in cardiovascular medicine. In: Libby P, Bonow RO, Mann DL, Tomaselli GF, Bhatt DL, Solomon SD. Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine. 12th ed. Elsevier; 2022:117-122. https://www.clinicalkey.com. Accessed February 21, 2023.
• ECRI Institute. Clinical Evidence Assessment. AngelMed Guardian System (Angel Medical Systems, Inc.) for monitoring patients at high risk of acute coronary syndrome. https://www.ecri.org. Published January 17, 2020. Updated February 23, 2022. Accessed February 15, 2023.
• ECRI Institute. Clinical Evidence Assessment. BioTel MCOT (BioTelemetry, Inc.) for diagnosing and managing cardiac arrhythmias. https://www.ecri.org. Published March 18, 2019. Updated September 1, 2022. Accessed February 15, 2023.
• ECRI Institute. Clinical Evidence Assessment. BodyGuardian Heart (Preventice Solutions, Inc.) for aiding diagnosis of cardiac arrhythmias. https://www.ecri.org. Published September 23, 2020. Updated May 5, 2022. Accessed February 15, 2023.
• ECRI Institute. Clinical Evidence Assessment. Carnation ambulatory monitor (Bardy Diagnostics, Inc.) for cardiac arrhythmias. https://www.ecri.org. Published June 25, 2018. Updated January 28, 2022. Accessed February 15, 2023.
• ECRI Institute. Clinical Evidence Assessment. Confirm Rx insertable cardiac monitor (Abbott Laboratories) for diagnosing and monitoring cardiac arrhythmia. https://www.ecri.org. Published September 30, 2018. Updated September 29, 2022. Accessed February 28, 2023.
• ECRI Institute. Clinical Evidence Assessment. LUX-Dx insertable cardiac monitor (Boston Scientific Corp.) for patients at risk of cardiac arrhythmia. https://www.ecri.org. Published June 1, 2021. Accessed February 15, 2023.
• ECRI Institute. Clinical Evidence Assessment. MoMe Kardia (InfoBionic) for aiding diagnosis of cardiac arrhythmias. https://www.ecri.org. Published May 9, 2022. Accessed February 15, 2023.
• ECRI Institute. Outpatient cardiac telemetry monitors for diagnosing and managing cardiac arrhythmias. https://www.ecri.org. Published March 25, 2019. Updated January 31, 2022. Accessed February 15, 2023.

ECRI Institute. Clinical Evidence Assessment. Overview of selected ambulatory cardiac monitoring systems for aiding diagnosis of cardiac arrhythmias. https://www.ecri.org. Published September 1, 2022. Accessed February 15, 2023.

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• ECRI Institute. Clinical Evidence Assessment. Reveal LINQ II insertable cardiac monitor (Medtronic plc.) for adults at risk of cardiac arrhythmia. https://www.ecri.org. Published October 1, 2018. Updated March 15, 2023. Accessed March 16, 2023.
• ECRI Institute. Clinical Evidence Assessment. Reveal LINQ II insertable cardiac monitor (Medtronic plc.) for children at risk of cardiac arrhythmia. https://www.ecri.org. Published October 1, 2018. Updated March 17, 2023. Accessed March 23, 2023.
• ECRI Institute. Clinical Evidence Assessment. RhythmStar (Rhythmedix) for aiding diagnosis of cardiac arrhythmias. https://www.ecri.org. Published August 8, 2022. Accessed February 15, 2023.
• ECRI Institute. Clinical Evidence Assessment. VitalPatch Biosensor (VitalConnect, Inc.) for continuous vital signs monitoring in patients with COVID-19. https://www.ecri.org. Published May 8, 2018. Updated May 21, 2020. Accessed February 15, 2023.
• ECRI Institute. Clinical Evidence Assessment. Zio Patch (iRhythm Technologies, Inc.) for aiding diagnosis of cardiac arrhythmias. https://www.ecri.org. Published August 22, 2013. Updated May 5, 2022. Accessed February 15, 2023.
• ECRI Institute. Hotline Response (ARCHIVED). Mobile cardiac outpatient telemetry for detecting arrhythmias. https://www.ecri.org. Published March 15, 2005. Updated November 30, 2014. Accessed February 15, 2023.
• Hayes, Inc. Evidence Analysis Research Brief. The AngelMed Guardian System for management of acute coronary syndrome. https://evidence.hayesinc.com. Published January 10, 2022. Accessed February 15, 2023.
• Hayes, Inc. Evolving Evidence Review. Clinical utility of mobile medical applications for detection of cardiac arrhythmia episodes. https://evidence.hayesinc.com. Published June 8, 2021. Accessed February 15, 2023.
• Hayes, Inc. Evolving Evidence Review. Zio Monitors (iRhythm) for heart rhythm monitoring in pediatrics. https://evidence.hayesinc.com. Published September 21, 2022. Accessed February 15, 2023.
• Hayes, Inc. Health Technology Brief (ARCHIVED). Implantable cardiac loop recorders for detection of atrial fibrillation following cryptogenic stroke. https://evidence.hayesinc.com. Published June 15, 2017. Updated July 18, 2019. Accessed February 15, 2023.
• Hayes, Inc. Health Technology Brief (ARCHIVED). Mobile cardiac outpatient telemetry (MCOT) (CardioNet ambulatory ECG monitor; CardioNet Inc.) for home monitoring of cardiac patients. https://evidence.hayesinc.com. Published September 23, 2011. Updated October 16, 2013. Accessed February 15, 2023.
• Hayes, Inc. Health Technology Brief (ARCHIVED). Zio Patch (iRhythm Technologies, Inc.) long-term ambulatory cardiac rhythm monitoring. https://evidence.hayesinc.com. Published February 7, 2019. Updated April 30, 2021. Accessed February 15, 2023.

Ambulatory Cardiac Monitoring Devices Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 03/23/2023 Policy Number: HUM-0435-032 Page: 23 of 28

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

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