Medical Policy

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Medical Policy

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

Policy Number: OCA 3.35 Version Number: 24 Version Effective Date: 03/01/21

Product Applicability All Plan+ Products

Well Sense Health Plan Boston Medical Center HealthNet Plan Well Sense Health Plan MassHealth Qualified Health Plans/ConnectorCare/Employer Choice Direct Senior Care Options ◊

Notes: + Disclaimer and audit information is located at the end of this document. ◊ The guidelines included in this Plan policy are applicable to members enrolled in Senior Care Options only if there are no criteria established for the specified service in a Centers for Medicare & Medicaid Services (CMS) national coverage determination (NCD) or local coverage determination (LCD) on the date of the prior authorization request. Review the member’s product-specific benefit documents at www.SeniorsGetMore.org to determine coverage guidelines for Senior Care Options.

Policy Summary The Plan considers the use of ambulatory cardiac monitors in the outpatient setting to be medically necessary if the type of ambulatory cardiac monitor is covered for the Plan member and ALL applicable Plan criteria are met, as specified in the Medial Policy Statement and Limitations sections of this policy. Plan prior authorization is required. When the device is covered for the member, medically necessary ambulatory cardiac monitors utilized in the outpatient setting may include ambulatory cardiac event monitors, mobile cardiac outpatient telemetry, and/or single-use external ambulatory electrocardiographic monitoring patches available by prescription.

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

+ Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan. 1 of 37

It is important to review the member’s applicable benefit documents to determine if the member has coverage for the specific type of ambulatory cardiac monitor that will be utilized to evaluate symptoms and/or implement the outpatient plan of care. Benefit documents are available at www.bmchp.org for a BMC HealthNet Plan member, at www.SeniorsGetMore.org for a Senior Care Options member, and at www.wellsense.org for a Well Sense Health Plan member. Holter monitoring does NOT require Plan prior authorization when conducted in an outpatient setting.

When applicable medical criteria are met, the Plan considers the use of ambulatory cardiac event monitors (also known as ambulatory electrocardiography monitors or AECG monitors) in the outpatient setting to be medically necessary as a diagnostic tool using non-continuous monitoring to evaluate eligible members with symptoms suggestive of cardiac arrhythmias; AECG monitors include pre-symptom memory loop recorders, post-symptom recorders, and implantable loop recorders. Ambulatory cardiac monitoring using a single-use external ambulatory electrocardiographic (ECG) monitoring patch available by prescription (e.g., Zio Patch system by iRhythm Technologies, Inc.) is considered medically necessary when the Plan’s applicable medical necessary are met and it is prescribed by a treating provider. Mobile cardiac outpatient telemetry (MCOT) provides continuous, real-time ambulatory electrographic monitoring and analysis of symptoms consistent with cardiac dysrhythmias. MCOT is considered medically necessary when used as a diagnostic alternative to ambulatory AECG monitors when service-specific MCOT criteria are met and MCOT is a covered service for the member. MCOT is a benefit exclusion for Well Sense Health Plan members and therefore is NOT a covered service for Well Sense members.

The use of self-monitoring ECG technologies available without a prescription, ambulatory cardiac monitoring devices/patches that do not meet criteria specified in the Medical Policy Statement section of this policy, and/or other types of emerging and unproven technologies is considered experimental and investigational when used as a diagnostic tool to evaluate symptoms suggestive of a cardiac etiology or for any other indication, as specified in the Limitations section of this policy. It will be determined during the Plan’s prior authorization process if the service is considered medically necessary, experimental and investigational, or not medically necessary for the requested indication. The Plan’s Medically Necessary medical policy, policy number OCA 3.14, includes the product-specific definitions of medically necessary treatment, and the Plan’s Experimental and Investigational Treatment medical policy, policy number OCA 3.12, outlines the product-specific definitions of experimental or investigational treatment.

All inpatient admissions require Plan prior authorization, as stated in the Prior Authorization/ Notification Requirements Matrix available at www.bmchp.org for BMC HealthNet Plan members (including Senior Care Options members) and www.wellsense.org for Well Sense Health Plan members. Cardiac monitoring conducted during an authorized inpatient stay does NOT require a separate Plan authorization.

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

Description of Item or Service Ambulatory Cardiac Monitors: There are a wide variety of devices available to conduct outpatient cardiac rhythm monitoring with ambulatory patients and may combine features of multiple classes of devices; variations include the types of monitoring leads used, the duration and continuity of monitoring (i.e., continuous or intermittent monitoring), the ability to detect arrhythmias with or without patient intervention (i.e., automatically activated or patient activated), and/or the mechanism of delivering the information from patient to clinician. Medically necessary ambulatory cardiac monitors include ambulatory cardiac event monitors (i.e., pre-symptom memory loop recorders, post- symptom recorders, and implantable loop recorders), mobile cardiac outpatient telemetry, and/or single-use external ambulatory electrocardiographic monitoring patches ONLY available by prescription when the type of ambulatory cardiac monitor is covered for a member and ALL applicable Plan criteria are met, as specified in the Medial Policy Statement and Limitations sections of this policy.

Ambulatory cardiac event monitors/ambulatory electrocardiography (AECG) monitors are similar to mobile cardiac outpatient telemetry (MCOT) but with these important differences: (1) Unlike the AECG monitors (with non-continuous monitoring), the MCOT device is completely automatic, continuous, and requires no patient intervention to capture electrocardiographic data when an arrhythmia occurs; and (2) MCOT electrocardiographic data are automatically transmitted to a central service center for immediate interpretation when an arrhythmia is detected. Like a MCOT, the duration of an AECG study is typically up to 30 days. Unlike Holter monitors, event monitors (including pre-symptom recorders, post-symptom recorders, and implantable loop recorders) do not continuously record the heart's electrical activity. The Plan considers single-use ambulatory electrocardiographic (ECG) monitors, self-monitoring ECG technologies, and/or other types of emerging and unproven technology to be experimental and investigational as a diagnostic alternative to AEG monitors and/or MCOT in patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of cardiac arrhythmias or for any other indication.

Ambulatory Cardiac Event Monitors/Ambulatory Electrocardiography (AECG) Monitors: Portable, external devices or implantable devices that are used to detect, store, and record electrocardiogram (ECG) data using non-continuous monitoring while a patient is engaged in daily activities, including sleep. These devices are worn externally by patients or subcutaneously inserted into patients to evaluate symptoms that are suggestive of cardiac arrhythmias such as palpitations, dizziness, chest pain, shortness of breath, presyncope, or syncope.

Ambulatory AECG monitors document cardiac rhythm on an intermittent basis and devices may be worn externally or implanted. An ambulatory cardiac event monitor with an external loop recorder is activated by the patient when a symptom occurs (pre-symptom continuous loop and post-symptom recorders) or the device is equipped with an auto-trigger external loop recorder to document an asymptomatic event (but still requires that the patient transmit documentation of the event after the asymptomatic episode). An ambulatory AECG monitor with an implantable loop recorder performs the same function as an external loop recorder but the inserted device is implanted subcutaneously in the chest region and can be used for longer periods of time. The Plan considers the use of ambulatory

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

AECG monitors to be medically necessary as a diagnostic tool to intermittently evaluate eligible members with symptoms suggestive of cardiac arrhythmias.

Examples of AECG monitors include:

1. Pre-symptom (External) Memory Loop Recorder: The patient, upon detecting symptoms, activates the external device, or the device can be activated automatically by sensing the event which triggers the recording. These devices are typically worn at all times for up to 30 days.

2. Post-symptom (External) Recorder: The patient temporarily places this external device against his/her chest when symptoms occur and activates the device by pressing a button. The data can be transmitted telephonically in real time or may have a memory loop to store data. These devices are typically worn for up to 30 days.

3. Implantable Loop Recorder (ILR): Also known as an insertable loop recorder, this device is a subcutaneous monitoring recorder for the detection of cardiac arrhythmias. The device is typically implanted in the left pectoral region and stores events when the device is activated automatically according to programmed criteria. The device can also record data when manually activated with a magnet. Insertion is a simple outpatient procedure performed under local anesthesia. These devices may remain implanted for several months.

Mobile Cardiac Outpatient Telemetry (MCOT): Also known as an automatic outpatient cardiac monitoring device, MCOT is a mobile device that provides continuous, real-time ambulatory electrographic monitoring and analysis that is automatically activated and used as a diagnostic alternative to ambulatory event monitors in patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of cardiac arrhythmias. MCOT is a completely automatic and continuous cardiac monitoring device that requires no patient intervention to capture electrocardiographic (ECG) data when an arrhythmia occurs; also known as real-time cardiac monitoring or real-time continuous attended cardiac monitoring system. MCOT overcomes limitations of Holter monitors and patient-activated event recorders by providing continuous outpatient ECG monitoring for periods ranging up to several weeks, if necessary. The device consists of a three (3)- electrode and a two (2)-channel sensor; the sensor transmits wirelessly to a small portable monitor which can be clipped to the waist or worn on a strap around the neck. Rhythm strips are recorded continuously and analyzed by an automated arrhythmia analysis algorithm. When an arrhythmia is detected, the monitor can transmit the ECG data to the monitoring center utilizing a cellular modem or telephone data line. The patient’s physician is made aware of arrhythmias based on pre-determined notification criteria, tailored to the patient by the physician. Certified cardiovascular technicians analyze the transmissions 24 hours a day, 7 days a week. The prescribing physician selects individualized monitoring thresholds and response parameters. Routine daily telemetry reports are issued to the physician by email, fax, internet or phone. MCOT is similar to AECG monitoring but with these important differences: (1) Unlike the ambulatory cardiac event monitors (with non-continuous monitoring), the MCOT device is completely automatic and continuous; and (2) with MCOT the electrocardiographic data are automatically transmitted to a central service center for immediate Ambulatory Cardiac Monitors (Excluding Holter Monitors)

interpretation when an arrhythmia is detected. Like ambulatory cardiac event monitoring, the duration of an MCOT study is typically up to 30 days. See the member’s applicable benefit documents available at www.bmchp.org for benefit coverage and associated guidelines for MCOT for a BMC HealthNet Plan member, at www.SeniorsGetMore.org for a Senior Care Options member, and at www.wellsense.org for a Well Sense Health Plan member. MCOT is a benefit exclusion for Well Sense Health Plan members and therefore is NOT a covered service for Well Sense members.

Self-Monitoring Electrocardiogram (ECG) Technologies: Health monitoring devices (wireless or non- wireless which may be attached to a finger, ear lobe or other body part) or software applications for smartphones and other electronic devices available without a prescription used to monitor ECG, heart rate, oxygen saturation, respiratory rate, and other non-cardiac indications. An example of such a device includes Kardia Mobile (developed by AliveCor and formerly marketed as AliveCor Mobile); Kardia Mobile is a single-channel cardiac event recorder, captures a medical-grade ECG in 30 seconds. The device converts electrical impulses from the user’s fingertips into ultrasound signals that are transmitted to a mobile device’s microphone. Kardia uses FDA-cleared algorithms to instantly analyze the ECG tracing and, in consultation with board-certified cardiologists, can assist in determining the presence of atrial fibrillation or normal sinus rhythm. The device allows users to easily track palpitations, shortness of breath, and dietary, sleep, and exercise patterns. Currently, Kardia Mobile works with iPhone, iPad, and iPod Touch devices, and most Android operating systems, enabling users to capture heart activity data and relay these to their doctor for diagnosis and treatment planning. The Kardia monitors are intended for use in adult patients and are cleared through the FDA 510(k) process as class II devices. Kardia devices have not been tested and are not intended for pediatric use. Kardia is a new technology that competes with Holter monitoring, event monitoring and mobile cardiac outpatient telemetry (MCOT). Currently, there is insufficient scientific evidence in the peer reviewed medical literature to support the effectiveness of Kardia devices or other self-monitoring ECG technologies, with user difficulties also documented in clinical studies.

Single-Use External Ambulatory Electrocardiographic (ECG) Monitoring Patch: Ambulatory ECG monitoring device designed for single use to provide continuous or non-continuous monitoring and only available with a prescription. Zio Patch system (developed by iRhythm Technologies Inc.) is the first commercially available, single-use and waterproof ambulatory ECG monitoring patch; the Zio Patch provides continuous monitoring for up to 14 days for patients with suspected cardiac arrhythmia(s) and stores data for a longer period than a traditional Holter. The device is configured with a single lead, monitor, and data storage in an adhesive patch that is approximately 2 x 5 inches. ECG data are stored in an internal flash drive and a patch is applied to the patient’s left pectoral area, and the patient is instructed to wear the patch until it no longer adheres to their skin, or up to 14 days. Patients can press a button on the Zio Patch when they recognize a symptomatic episode. The patient mails the monitor to a central diagnostic testing facility for evaluation. Zio Patch is waterproof, small, and wire free, which may improve patient compliance with use of the device. The Zio ECG Utilization Service (ZEUS) system is a comprehensive system that processes and analyzes received ECG data captured by long-duration, single-lead, continuous recording diagnostic devices (e.g., the Zio Patch and Zio Event Card). The Zio Patch/Zio Event Card is a new technology that competes with Holter monitoring, event monitoring, and mobile cardiac outpatient telemetry (MCOT). The Plan considers Ambulatory Cardiac Monitors (Excluding Holter Monitors)

the use of a single-use ambulatory EEG monitor prescribed by a treating provider to be medical necessary when applicable Plan criteria are met.

Medical Policy Statement Plan prior authorization is required for the use of ambulatory cardiac monitors in the outpatient setting. Holter monitoring does NOT require Plan prior authorization when conducted in an outpatient setting. Cardiac monitoring conducted during an authorized inpatient stay does NOT require a separate Plan authorization.

Ambulatory cardiac monitors used in the outpatient setting, including ambulatory cardiac event monitors/AECG monitors (i.e., pre-symptom memory loop recorders, post-symptom recorders, and implantable loop recorders), mobile cardiac outpatient telemetry (MCOT), and/or single-use external ambulatory electrocardiographic (ECG) monitoring patches available only by prescription are considered medically necessary when the type of ambulatory cardiac monitor is covered for the member and ALL applicable Plan criteria are met and documented in the member’s medical record, as specified below in item A for ambulatory cardiac event monitors/AECG monitors, item B for mobile cardiac outpatient telemetry (MCOT), or item C for single-use external ambulatory ECG monitoring patch available only by prescription:

A. Ambulatory Cardiac Event Monitors/Ambulatory Electrocardiography (AECG) Monitors:

The following applicable criteria must be met for a Plan member, as listed below in item 1 (for pre- symptom external recorders and post-symptom external recorders) or item 2 (for implantable loop recorders):

1. Criteria for External AECG Pre-Symptom External Recorders or AECG Post-Symptom External Recorders: **

External AECG pre-symptom external records or AECG post-symptom external recorders are considered medically necessary when ordered by the member’s treating provider, with treating provider defined as a physician board certified in a cardiology specialty or the member’s primary care provider (i.e., primary care physician or licensed independent practitioner such as a nurse practitioner or physician assistant serving as the member’s PCP) in consultation with a physician specialist who is board certified in a cardiology specialty and the applicable criteria are met for EITHER initial testing (as specified below in item a) or repeat testing (as specified below in item b):

a. Initial Testing (Up to Twice in a Calendar Year):

At least ONE (1) of the following criteria is met for initial testing, as specified below in item (1) or item (2) for initial testing:

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

(1) AECG pre-symptom recorders and/or AECG post-symptom recorders are used as a diagnostic alternative to Holter monitoring when ALL of the following criteria are met, as specified below in items (a) through (c):

(a) The member experiences infrequent symptoms (i.e., symptom less frequently than every 48 hours); AND

(b) The member is age 18 or older on the date of service; AND

(c) The member’s symptoms are suggestive of an arrhythmia that include but are not limited to ANY of the following, as specified below in items i through iv:

i. Member with presyncope or episodic dizziness without obvious cause; OR

ii. Member with unexplained recurrent palpitations; OR

iii. Member with unexplained syncope; OR

iv. Member experiencing other symptom suggestive of arrhythmia, as determined by the treating provider; OR

(2) Member has had a cryptogenic stroke and ALL of the following criteria are met, as specified below in items (a) through (d):

(a) The member is age 18 or older on the date of service; AND

(b) Initial AECG testing will be conducted within ONE (1) month from the time the stroke was diagnosed (which only applies to the initial testing); AND

(c) AECG monitoring will be used to detect suspected paroxysmal atrial fibrillation when prior testing with Holter monitoring has yielded inconclusive results; AND

(d) The results of AECG monitoring will be used to guide medical management with anticoagulants; OR

b. Repeat Testing (More Than Twice in a Calendar Year):

BOTH of the following criteria are met for repeating testing, as specified below in item (1) and item (2):

(1) Repeat testing must meet applicable criteria for initial testing, as specified above in item 1a of this section; AND

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

(2) At least ONE (1) of the following criteria is met, as specified below in item (a) or item (b) for repeat testing: ***

(a) Testing with AECG pre-symptom recorders and/or AECG post-symptom recorders has not been performed more than twice in the past one (1)-year period (i.e., past 12 consecutive calendar months) for the member’s current symptom; OR

(b) Testing with AECG pre-symptom recorders and/or AECG post-symptom recorders has been performed more than twice in the past one-year period (i.e., past 12 consecutive calendar months), but the repeat test will be used to evaluate a new or recurrent, undiagnosed symptom that meets Plan criteria for the AECG pre-symptom recorders and AECG post-symptom recorders; OR

Notes Related to AECG Pre-symptom Recorders and AECG Post-symptom Recorders:

** AECG pre-symptom recorders and/or AECG post-symptom recorders may be authorized for a total of 30 consecutive calendar days for the purpose of documenting the diagnosis of arrhythmias; however, the testing may be discontinued once the symptom-producing arrhythmia has been documented. The average duration of service is 14 consecutive calendar days or more.

*** The Plan requires Medical Director review to determine the medical necessity of a request for a repeat study that does NOT meet Plan criteria, as specified in this policy.

2. Criteria for Implantable Loop Recorders:

Implantable loop recorders are considered medically necessary when ordered by the member’s treating physician board certified in a cardiology specialty and ALL of the following applicable criteria are met for an implantable loop recorder, as specified below in items a through c:

a. The member is age 18 or older on the date of service; AND

b. An implantable loop recorder is used when conventional diagnostic testing (such as electrocardiogram, Holter monitoring, AECG external pre-symptom loop recorder and/or AECG post-symptom loop recorder) is inconclusive in the evaluation of at least ONE (1) of the following conditions, as specified below in items (1) through (4):

(1) Apparent life-threatening event (ALTE); OR

(2) Cryptogenic stroke with testing used to detect suspected paroxysmal atrial fibrillation to guide medical management with anticoagulants; OR

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

(3) Presyncope, OR

(4) Recurrent unexplained episodes of syncope; AND

c. When a cardiac arrhythmia is the suspected cause of symptoms in a member (with or without structural heart disease), as determined by the treating provider; OR

B. Mobile Cardiac Outpatient Telemetry (MCOT): ⱡ

The Plan considers the use of MCOT to provide continuous, real-time ambulatory electrographic monitoring and analysis to be medically necessary as a diagnostic alternative to AECG monitors ONLY when service-specific criteria are met and MCOT is a covered service for the member. Review the member’s applicable benefit documents for MCOT coverage guidelines posted at www.bmchp.org for a BMC HealthNet Plan member, at www.SeniorsGetMore.org for a Senior Care Options member, and at www.wellsense.org for a Well Sense Health Plan member. MCOT is a benefit exclusion for Well Sense Health Plan members and therefore is NOT a covered service for Well Sense members.

For BMC HealthNet Plan members with MCOT as a covered service, the Plan considers the use of MCOT medically necessary when it is ordered by the member’s treating provider, with treating provider defined as a physician board certified in a cardiology specialty or the member’s primary care provider (i.e., primary care physician or licensed independent practitioner such as a nurse practitioner or physician assistant serving as the member’s PCP) in consultation with a physician specialist who is board certified in a cardiology specialty and ALL of the following applicable criteria are met, as specified below in items 1 through 4:

1. The member is age 18 or older on the date of service; AND

2. The treating provider has determined that the member has a low likelihood of a potentially life- threatening cardiac event; AND

3. The member has received other diagnostic cardiac monitoring (i.e., hospital inpatient telemetry, Holter monitoring, or AECG monitoring) with inconclusive results; AND

4. MCOT will be used for at least ONE (1) of the following indications, as specified below in items a through d:

a. The member is experiencing infrequent symptoms (less frequently than every 48 hours) suggestive of a cardiac arrhythmias which include at least ONE (1) of the following, as specified below in items (1) through (4):

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

(1) Member with pre-syncope or episodic dizziness without obvious cause; OR

(2) Member with unexplained recurrent palpitations; OR

(3) Member with unexplained syncope; OR

(4) Member experiencing other symptom suggestive of arrhythmia, as determined by the treating provider (e.g., chest pain, shortness of breath); OR

b. Evaluation of an arrhythmia during initiation, revision, or discontinuation of anti-arrhythmic drug therapy; OR

c. Evaluation of an arrhythmia during recovery from surgical or ablative procedure for arrhythmia or myocardial infarction; OR

d. Evaluation of atrial fibrillation as possible etiology after cryptogenic stroke.

ⱡ Notes Related to MCOT:

When applicable Plan criteria are met and MCOT is a covered service for the member, the Plan will authorize one (1) medically necessary MCOT monitoring session as a diagnostic tool to evaluate the member’s condition/symptoms (with an average duration of 10 to 14 consecutive calendar days and not to exceed 30 consecutive calendar days per session).

When applicable Plan criteria are met and MCOT is a covered service for the member, MCOT may be authorized for a total of 30 consecutive calendar days for the purpose of documenting the diagnosis of arrhythmias; however, it is expected that the testing will be discontinued once the symptom-producing arrhythmia has been adequately documented.

MCOT monitoring beyond 30 consecutive calendar days or subsequent sessions within 12 consecutive calendar months of an approved MCOT session requires Plan Medical Director review.

C. Single-use External Ambulatory Electrocardiographic (ECG) Monitoring Patch Available Only by Prescription: ∞

The use of a single-use external ambulatory EEG monitoring patch (e.g., Zio Patch system) available only by prescription is considered medically necessary when ordered by the member’s treating provider for continuous cardiac monitoring, with treating provider defined as a physician board certified in a cardiology specialty or the member’s primary care provider (i.e., primary care physician or licensed independent practitioner such as a nurse practitioner or physician assistant serving as the member’s PCP) in consultation with a physician specialist who is board certified in a

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

cardiology specialty and ALL of the following applicable criteria are met for the Plan member, as specified below in items 1 through 4:

1. The member is age 18 or older on the date of service; AND

2. The treating provider has determined that the member has a low likelihood of a potentially life- threatening cardiac event; AND

3. The single-use external ambulatory EEG monitoring patch will be used for continuous cardiac monitoring, and the device is FDA cleared or FDA approved for this indication (e.g., Zio Patch system by iRhythm Technologies, Inc.); AND

4. The device will be used to evaluate at least ONE (1) of the following medical conditions for a Plan member and a single-use external ambulatory ECG monitoring patch has NOT be utilized to evaluate the member’s medical condition over the past 12 calendar months), as specified below in items a through c:

a. Single-use external ECG monitoring patch (e.g., Zio Patch system) will be used for continuous cardiac monitoring as a diagnostic alternative to Holter monitoring with a member experiencing symptoms less frequently than once every 48 hours with at least ONE (1) of the following symptoms suggestive of cardiac arrhythmias, as specified below in items (1) through (3):

(1) Member with pre-syncope or episodic dizziness without obvious cause; OR

(2) Member with unexplained recurrent palpitations; OR

(3) Member with recurrent unexplained episodes of syncope; OR

b. Single-use external ECG monitoring patch (e.g., Zio Patch system) will be used for continuous cardiac monitoring for a member who has had a cryptogenic stroke to detect suspected paroxysmal atrial fibrillation when prior testing with Holter monitoring has yielded inconclusive results and when external ambulatory event monitoring is intended to guide medical management with anticoagulants; OR

c. Single-use external ECG monitoring patch (e.g., Zio Patch system) will be used for continuous cardiac monitoring for a member with atrial fibrillation who has been treated with catheter ablation and discontinuation of systemic anticoagulation is being considered for the member.∞

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

∞ Notes Related to Single-use External Ambulatory EEG Monitoring Patch Available Only by Prescription:

The Plan will authorize one (1) medically necessary monitoring session as a diagnostic tool to evaluate the member’s condition/symptoms (with an average duration of 10 to 14 consecutive calendar days and not to exceed 30 consecutive calendar days per session) when Plan applicable criteria are met.

Single-use external ECG monitoring patch (e.g., Zio Patch system) may be authorized for a total of 30 consecutive calendar days for the purpose of documenting the diagnosis of arrhythmias; however, it is expected that the testing will be discontinued once the symptom-producing arrhythmia has been adequately documented.

Monitoring beyond 30 consecutive calendar days or subsequent sessions within 12 consecutive calendar months of an approved session using of single-use external ECG monitoring patch (e.g., Zio Patch system) requires Plan Medical Director review.

Limitations Ambulatory cardiac monitors used in the outpatient setting, including ambulatory cardiac event monitors (i.e., pre-symptom memory loop recorders, post-symptom recorders, and implantable loop recorders), mobile cardiac outpatient telemetry, and/or single-use external ambulatory electrocardiographic monitoring patches available by prescription (e.g., Zio Patch system) are considered medically necessary when the type of ambulatory cardiac monitor is a covered service for the member and ALL applicable Plan criteria are met, as specified in the Medial Policy Statement section of this policy and according to the limitations stated below. It is important to review the member’s applicable benefit documents to determine if the member has coverage for the specific type of ambulatory cardiac monitor that will be utilized to evaluate symptoms and/or implement the plan of care in an outpatient setting. Benefit documents are available at www.bmchp.org for a BMC HealthNet Plan member, at www.SeniorsGetMore.org for a Senior Care Options member, and at www.wellsense.org for a Well Sense Health Plan member. MCOT is a benefit exclusion for Well Sense Health Plan members and therefore is NOT a covered service for Well Sense members.

ANY of the following is considered a limitation for ambulatory cardiac monitoring in the outpatient setting, as specified below in items 1 through 4:

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

1. Ambulatory Cardiac Event Monitors/Ambulatory Electrocardiography (AECG) Monitors:

a. Contraindications for AECG monitors include ONE (1) or more of the following, as specified below in item (1) or item (2):

(1) Inability of the adhesive electrode patch to affix to the member’s skin; OR

(2) Inability of the member to wear the monitor consistently over the monitoring period.

b. The Plan considers ANY of the following uses for AECG monitors to be experimental and investigational, as specified below in item (1) or item (2):

(1) For monitoring the effectiveness of anti-arrhythmia therapy and detection of myocardial ischemia by detecting ST segment changes; OR

(2) Following catheter or surgical ablation of atrial fibrillation when Plan criteria are not met, as specified in the Medical Policy Statement section of this policy.

2. Single-Use External Ambulatory ECG Monitoring Patch (e.g., Zio Patch):

a. Contraindications for single-use external ambulatory ECG monitoring patch include ONE (1) or more of the following, as specified below in items (1) through (5):

(1) Member with symptomatic episodes where instance variations in cardiac performance could result in immediate danger to the member; OR

(2) In combination with external cardiac defibrillators or high-frequency surgical equipment; OR

(3) Near strong magnetic fields or devices, such as magnetic resonance imaging; OR

(4) Member with a neurostimulator (since the neurostimulator may disrupt the quality of the ECG data); OR

(5) Inability of the member to wear the device consistently over the prescribed monitoring period.

b. The Plan considers ANY of the following uses for single-use external ambulatory ECG monitoring patch to be experimental and investigational, as specified below in item (1) or item (2):

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

(1) The use of a single-use external ambulatory external ECG monitoring patch is considered experimental and investigational when used WITHOUT a prescription from a treating provider who is either a physician board certified in a cardiology specialty or the member’s primary care provider (i.e., primary care physician or licensed independent practitioner such as a nurse practitioner or physician assistant serving as the member’s PCP) in consultation with a physician specialist who is board certified in a cardiology specialty; OR

(2) The use of a single-use external ambulatory external ECG monitoring patch is considered experimental and investigational if the device is NOT FDA approved or NOT utilized according to FDA-approved guidelines for treatment.

3. Plan Medical Director Review Required:

ANY of the following types of prior authorization requests requires Plan Medical Director review, as specified below in items a through f:

a. Members Younger than Age 18:

Plan Medical Director review is required for ambulatory cardiac event monitoring (including external AECG pre-symptom external recorders, AECG post-symptom external recorders, and/or implantable loop recorders), single-use external ambulatory ECG monitoring patch (e.g., Zio Patch), and/or mobile cardiac outpatient telemetry (MCOT) monitoring for a member younger than age 18 on the date of service.

b. MCOT as First Method of Ambulatory Monitoring:

Plan Medical Director review is required for MCOT monitoring when used as the first method of ambulatory monitoring for a Plan member (rather than other diagnostic cardiac monitoring such as hospital inpatient telemetry, Holter monitoring, and/or AECG monitoring after inconclusive results).

c. Timeframe for AECG Monitoring:

ANY of the following types of prior authorization requests require Plan Medical Director review, as specified below in item (1) or item (2):

(1) Plan Medical Director review is required for the use of AECG pre-symptom recorders and/or AECG post-symptom recorders for a member in excess of 30 consecutive calendar days per session or when testing is continued after the symptom-producing arrhythmia has been documented; OR

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

(2) For repeat AECG monitoring with AECG pre-symptom recorders and/or AECG post- symptom recorders, Plan Medical Director review is required when AECG monitoring has already been performed two (2) or more sessions in the past one (1)-year period (i.e., past 12 consecutive calendar months) for the member’s current symptom(s).

d. Timeframe for MCOT:

Plan Medical Director review is required for MCOT monitoring in excess of 30 days per session or subsequent sessions of monitoring within the past 12 consecutive calendar months of an approved MCOT session.

e. Timeframe for Single-use External Ambulatory Electrocardiographic (ECG) Monitoring Patch:

ANY of the following types of prior authorization requests require Plan Medical Director review, as specified below in item (1) or item (2):

(1) Plan Medical Director review is required for monitoring in excess of 30 consecutive calendar days per session (or subsequent sessions of continuous monitoring within the past 12 consecutive calendar months of an approved session) using of single-use external ambulatory ECG monitoring patch (e.g., Zio Patch system) to verify that the most appropriate ambulatory cardiac monitor is utilized to evaluate the member’s condition and frequency of symptoms; OR

(2) Plan Medical Director review is required for requests for the use of single-use external ambulatory ECG monitoring patch for non-continuous cardiac monitoring to verify that the most appropriate ambulatory cardiac monitor is utilized to evaluate the member’s condition and frequency of symptoms.

f. Trans-Telephonic Transmission:

Plan Medical Director review is required for the trans-telephonic transmission of results from ambulatory cardiac monitoring for a member who lives in remote areas or at least 100 miles from a physician capable of interpreting the results; applicable Plan criteria must also be met and documented in the member’s medical record.

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

4. Self-monitoring Electrocardiographic (ECG) Technologies:

The use of self-monitoring ECG technologies that do NOT require a prescription from a treating physician/provider, ambulatory cardiac monitoring devices/patches that do NOT meet criteria specified in the Medical Policy Statement section of this policy, and/or other new and emerging technologies used to diagnose and/or monitor cardiac arrhythmias (e.g., Kardia) is considered experimental and investigational because the clinical utility and clinical validity of these technologies have not been consistently established; these self-monitoring and emerging technologies may include an ECG monitor combined with a cellular telephone, personal electronic device, and/or the use of additional software or hardware to download ECG data to a device such as personal computer, smart phone, or tablet.

Definitions Arrhythmia: Irregular heart action secondary to a physiological or pathological disturbance in the discharge of electrical impulses or in the electrical transmission that cause dysfunction of the heart pumping mechanism. Examples of arrhythmia include bradycardia and tachycardia. Serious arrhythmias include ventricular tachycardia (VT) and ventricular fibrillation (VF). Both VT and VF are the primary causes of sudden death.

Cryptogenic Stroke: A stroke of undetermined origin. Cryptogenic stroke is defined as a brain infarction that is not attributable to a source of definite cardioembolism, large artery atherosclerosis, or small artery disease despite extensive vascular, cardiac, and serologic evaluation.

Electrocardiogram (EKG or ECG): A test that measures the electrical activity of the heart and used to diagnose cardiac arrhythmias and a wide range of heart disease. Electrodes are placed on the body in predetermined locations to sense electrical activity of the heart.

Holter Monitor: A type of portable heart monitor that is a small electrocardiogram (ECG) device worn in a pouch around the neck or waist. A Holter monitor keeps a record of the heart rhythm, typically over a 24-hour period (up to 72 hours), and the patient keeps a diary of activities and symptoms while wearing the device continuously throughout the recording period. The ECG recording is then correlated with the person's activities and symptoms. This type of test is useful for identifying heart disturbances that are sporadic and not readily identified with a resting ECG.

Presyncope: Symptoms of dizziness or lightheadedness without loss of consciousness.

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

Applicable Coding The Plan uses and adopts up-to-date Current Procedural Terminology (CPT) codes from the American Medical Association (AMA), International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10) diagnosis codes developed by the World Health Organization and adapted in the United Stated by the National Center for Health Statistics (NCHS) of the Centers for Disease Control under the U.S. Department of Health and Human Services, and the Health Care Common Procedure Coding System (HCPCS) established and maintained by the Centers for Medicare & Medicaid Services (CMS). Since the AMA, NCHS, and CMS may update codes more frequently or at different intervals than Plan policy updates, the list of applicable codes included in this Plan policy is for informational purposes only, may not be all inclusive, and is subject to change without prior notification. Whether a code is listed in the Applicable Coding section of this Plan policy does not constitute or imply member coverage or provider reimbursement. Providers are responsible for reporting all services using the most up-to-date industry-standard procedure and diagnosis codes as published by the AMA, NCHS, and CMS at the time of the service.

Providers are responsible for obtaining prior authorization for the services specified in the Medical Policy Statement section and Limitation section of this Plan policy, even if an applicable code appropriately describing the service that is the subject of this Plan policy is not included in the Applicable Coding section of this Plan policy. Coverage for services is subject to benefit eligibility under the member’s benefit plan. Please refer to the member’s benefits document in effect at the time of the service to determine coverage or non-coverage as it applies to an individual member. See Plan reimbursement policies for Plan billing guidelines.

CPT Codes Description: Codes Covered When Medically Necessary 33285 Insertion, subcutaneous cardiac rhythm monitor, including programming 93228 External mobile cardiovascular telemetry with electrocardiographic recording, concurrent computerized real time data analysis and greater than 24 hours of accessible ECG data storage (retrievable with query) with ECG triggered and patient selected events transmitted to a remote attended surveillance center for up to 30 days; review and interpretation with report by a physician or other qualified health care professional

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

93229 External mobile cardiovascular telemetry with electrocardiographic recording, concurrent computerized real time data analysis and greater than 24 hours of accessible ECG data storage (retrievable with query) with ECG triggered and patient selected events transmitted to a remote attended surveillance center for up to 30 days; technical support for connection and patient instructions for use, attended surveillance, analysis and transmission of daily and emergent data reports as prescribed by a physician or other qualified health care professional

Plan notes: 1. Only CPT code 93228 or 93229 should be used when billing the Plan for mobile cardiac outpatient telemetry (MCOT) for a Plan member when it is a covered service. 2. This code is NOT covered (with MCOT listed as a benefit exclusion) for the Well Sense Health Plan products. 93241 External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage; includes recording, scanning analysis with report, review and interpretation 93242 External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage; recording (includes connection and initial recording) 93243 External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage; scanning analysis with report 93244 External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage; review and interpretation 93245 External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage; includes recording, scanning analysis with report, review and interpretation 93246 External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage; recording (includes connection and initial recording) 93247 External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage; scanning analysis with report 93248 External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage; review and interpretation 93268 External patient and, when performed, auto activated electrocardiographic rhythm derived event recording with symptom-related memory loop with remote download capability up to 30 days, 24-hour attended monitoring; includes transmission, review and interpretation by a physician or other qualified health care professional

Plan note: Code used for ambulatory cardiac event monitors.

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

93270 External patient and, when performed, auto activated electrocardiographic rhythm derived event recording with symptom-related memory loop with remote download capability up to 30 days, 24-hour attended monitoring; recording (includes connection, recording, and disconnection)

Plan note: Code used for ambulatory cardiac event monitors. 93271 External patient and, when performed, auto activated electrocardiographic rhythm derived event recording with symptom-related memory loop with remote download capability up to 30 days, 24-hour attended monitoring; transmission and analysis

Plan note: Code used for ambulatory cardiac event monitors. 93272 External patient and, when performed, auto activated electrocardiographic rhythm derived event recording with symptom-related memory loop with remote download capability up to 30 days, 24-hour attended monitoring; review and interpretation by a physician or other qualified health care professional

Plan note: Code used for ambulatory cardiac event monitors.

HCPCS Code Description: Code Covered When Medically Necessary E0616 Implantable cardiac event recorder with memory, activator and programmer

Plan note: Code used for ambulatory cardiac event monitors.

Clinical Background Information Palpitations are sensations of a rapid or irregular heartbeat and can result from many arrhythmias, including bradycardia, tachycardia, premature ventricular and atrial contractions, sick sinus syndrome, advanced arteriovenous block, or ventricular tachycardia. Episodes of arrhythmias perceived as palpitations can be asymptomatic or lead to syncope. Palpitations that are associated with dizziness, near-syncope, or syncope suggest tachyarrhythmia and are potentially more serious. Certain cardiac conditions can predispose the patient to arrhythmia and palpitations such as cardiomyopathy, congenital heart disease, congestive heart failure, valvular disease, and pericarditis. Non-cardiac causes of palpitations can include hyperthyroidism, vasovagal syncope, hypoglycemia, stimulant drugs, over-the-counter drugs, and prescription medications. The cause of palpitations can often be determined by history and physical examination. A 12-lead ECG evaluation is appropriate in all patients who complain of palpitations. High-risk patients who require ECG monitoring include those with organic heart disease or any heart abnormality that could predispose the patient to arrhythmias. Patients with a family history of arrhythmia, syncope, or sudden death may be at higher risk.

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

Cardiac arrhythmias occur when there is abnormal impulse formation or disordered conduction of electrical impulses within the myocardium. Depending on the type and severity, arrhythmias can cause palpitations, weakness, dizziness, syncope, hemodynamic complications, or death. Arrhythmias are classified as bradycardias when the heart rate falls below 60 bpm and as tachycardia when the heart rate exceeds 200 bpm. The most dangerous type of tachycardia is ventricular tachycardia; it can evolve into ventricular fibrillation, an arrhythmia that is fatal unless corrected immediately. Supraventricular tachycardia originates in the atria and disrupts the normal electrical conduction pathways in the heart. Atrial fibrillation, a relatively common form of supraventricular tachycardia, occurs due to chaotic, uncoordinated electrical activity that causes the atria to quiver. Although atrial fibrillation is not usually life threatening, it can cause transient weakness and distress that, if prolonged, may lead to stroke or cardiac muscle damage.

A variety of treatments have been developed for arrhythmias including anti-arrhythmic drugs, artificial pacemakers, implanted cardiac defibrillators, and ablation of damaged or malfunctioning cardiac tissue. Selection of the appropriate treatment requires an accurate diagnosis, which may be difficult when arrhythmias occur infrequently, unpredictably, or are asymptomatic. To detect infrequent arrhythmias, patients can undergo 24 to 48 hours of continuous outpatient electrocardiographic (ECG) recording with a Holter monitor. Repeated monitoring sessions may be necessary if an arrhythmia does not occur during the first 1 or 2 days. Another method for detecting infrequent arrhythmias is the use of an event recorder, which stores 1 to 2 minutes of ECG data as soon as the patient experiences symptoms and presses a button to activate the device; although this technique enables a much longer period of monitoring, some arrhythmias are asymptomatic or some symptomatic patients may fail to activate the event recorder at the appropriate time.

Ambulatory cardiac event monitors, also known as ambulatory electrocardiography (AECG) monitoring, is usually indicated if the patient’s history, physical examination, and resting ECG cannot determine the etiology of palpitations. AECG is used to characterize, detect, and document abnormal cardiac events that occur during daily activities. Because specific abnormalities may occur only during sleep, exercise, and mental or emotional stress, an ECG may need to be recorded over longer periods of time.

There are two (2) categories of AECG examinations: (1) Continuous recordings that are generally used for 24-48 hours; and (2) intermittent recordings over longer periods of time. Some intermittent event recorders have a memory loop that permits capture of fleeting symptoms, tachycardia onset, and in some cases syncope of infrequent occurrence. When monitoring is performed to evaluate the cause of intermittent symptoms, the frequency of symptoms should dictate the type of recording. Continuous recordings are indicated for the assessment of symptoms that occur frequently, at least once daily, for the assessment of syncope or near syncope and for patients with unexplained palpitations. Holter monitoring for 24-48 hours may be appropriate in patients with daily palpitations. When palpitations occur unpredictably, or do not occur daily, an initial two (2)-week course of continuous loop event recording may be indicated. Continuous monitoring may also be indicated for patients receiving anti- arrhythmic therapy to assess medication response, to monitor the rate of atrial fibrillation, to analyze the rhythm of patients with pacemakers, implantable cardioverter defibrillators (ICDs) and for the assessment of silent ischemia. Ambulatory Cardiac Monitors (Excluding Holter Monitors)

Implanted loop recorders (ILRs) are used to determine if the patient’s symptoms are related to the cardiac rate and can be used on patients with infrequent symptoms when other diagnostic tests are inconclusive. Some ILRs are able to record the ECG continuously with a battery life of 12 to 24 months. The device is typically inserted in the left pectoral region and is done under local anesthesia in an outpatient setting.

If an individual has undergone cardiac monitoring (i.e., hospital inpatient telemetry, Holter monitoring, and/or ambulatory cardiac event monitoring) with inconclusive results or when symptoms occur infrequently (less frequently than every 48 hours), mobile cardiac outpatient telemetry (MCOT) may be medically appropriate for the evaluation of recurrent and explained symptoms and/or for medical management. MCOT is a mobile device that provides continuous, real-time ambulatory electrographic monitoring and analysis that is automatically activated and therefore requires no patient intervention. Examples of MCOT include but are not limited to the following: Cardiac Telecom and Health Monitoring Services of America’s Telemetry @ Home Service, CardioNet Mobile Cardiac Outpatient Telemetry (MCOT) Service, Heartbreak ECAT (External Cardiac Ambulatory Telemetry) (Med net Healthcare Technologies), Heart 2005A, HEARTLink™ II ECG Arrhythmia Detector and Alarm System (Cardiac Telecom Corporation), LifeStar ACT (LifeWatch®, Inc.), SEEQ, Telemetry™ (Scott Care Cardiovascular Solutions) TeleSense 3-in 1 remote cardiac rhythm monitor, and Trove® (Biomedical Systems). At the current time the overall quality of the peer reviewed published evidence is low to verify the clinical utility of self-monitoring ECG technologies.

Continuous monitoring with a single-use external ambulatory ECG monitoring patch (including the Zio Patch system developed by iRhythm Technologies, Inc.) may be used as an alternative to Holter monitoring for targeted patient populations when prescribed by a qualified treating provider and when the results will impact clinical decision management. The Zio Patch system received FDA clearance in 2009.

At the time of the Plan’s most recent policy review, the Centers for Medicare & Medicaid Services (CMS) national coverage determination (NCD) 20.15 includes medically necessary indications for ambulatory electrocardiographic services. NCD 20.15 states that ambulatory cardiac monitoring is eligible for coverage by CMS if it is performed with a marketed, FDA-approved cardiac event device with “pre-event” or “post-event” recorders categorized as a CMS-covered device (e.g., ambulatory cardiac event monitors or Holter monitors) based on their memory capabilities and is used for at least one (1) of the following indications: Detect, characterize, and document symptomatic transient arrhythmias; initiate, revise, or discontinue arrhythmic drug therapy; or carry-out early post-hospital monitoring of patients discharged after myocardial infarction if 24-hour coverage is provided according to applicable CMS coverage guidelines. Unless there is an NCD for the specified device or service, determination as to whether a cardiac monitoring device or service that fits into the framework is reasonable and necessary is according to local Medicare Administrative Contractor (MAC) discretion, and CMS has issued a Decision Memo for Electrocardiographic Services (CAG-00158N) as a framework to aid local contractors in making reasonable and necessary determinations for specific technologies.

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

Verify CMS criteria in the applicable NCD or local coverage determination (LCD) and coverage guidelines in in effect on the date of the prior authorization request for a Senior Care Options member.

No clinical guidelines were found from CMS in an NCD or local coverage determination (LCD) specifically for automatic and continuous outpatient cardiac monitoring devices (including mobile cardiac outpatient telemetry [MCOT]), single-use ambulatory electrocardiographic (ECG) monitors (e.g., Zio Patch), and/or self-monitoring ECG technologies (e.g., Kardia). Determine if applicable CMS criteria are in effect for the cardiac monitoring device in an NCD or LCD on the date of the prior authorization request for a Senior Care Options member by evaluating the device’s memory capabilities and indications for use.

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Ambulatory Cardiac Monitors (Excluding Holter Monitors)

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Barrett PM, Komatireddy R, Haaser S, Topol S, Sheard J, Encinas J, Fought AJ, Topol EJ. Comparison of 24-hour Holter monitoring with 14-day novel adhesive patch electrocardiographic monitoring. Am J Med. 2014 Jan;127(1):95.e11-7. doi: 10.1016/j.amjmed.2013.10.003. Epub 2013 Oct 15. PMID: 24384108.

Benditt D. Syncope in adults: Clinical manifestations and diagnostic evaluation. UpToDate. 2020 May 13.

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

Bhangu J, McMahon CG, Hall P, Bennett K, Rice C, Crean P, Sutton R, Kenny RA. Long-term cardiac monitoring in older adults with unexplained falls and syncope. Heart. 2016 May;102(9):681-6. doi: 10.1136/heartjnl-2015-308706. Epub 2016 Jan 28. PMID: 26822427.

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Edvardsson N, Frykman V, van Mechelen R, Mitro P, Mohii-Oskarsson A, Pasquie JL, Ramanna H, Schwertfeger F, Ventura R, Voulgaraki D, Garutti C, Stolt P, Linker NJ; PICTURE Study Investigators. Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry. Europace. 2011 Feb;13(2):262-9. doi: 10.1093/europace/euq418. Epub 2010 Nov 19. PMID: 21097478.

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Ambulatory Cardiac Monitors (Excluding Holter Monitors)

Giada F, Gulizia M, Francese M, Croci F, Santangelo L, Santomauro M, Occhetta E, Menozzi C, Raviele A. Recurrent unexplained palpitations (RUP) study comparison of implantable loop recorder versus conventional diagnostic strategy. J Am Coll Cardiol. 2007 May 15;49(19):1951-6. Epub 2007 Apr 30. doi: 10.1016/j.jacc.2007.02.036. PMID: 17498580.

Gladstone DJ, Spring M, Dorian P, Panzov V, Thorpe KE, Hall J, Vaid H, O'Donnell M, Laupacis A, Côté R, Sharma M, Blakely JA, Shuaib A, Hachinski V, Coutts SB, Sahlas DJ, Teal P, Yip S, Spence JD, Buck B, Verreault S, Casaubon LK, Penn A, Selchen D, Jin A, Howse D, Mehdiratta M, Boyle K, Aviv R, Kapral MK, Mamdani M; EMBRACE Investigators and Coordinators. Atrial fibrillation in patients with cryptogenic stroke. N Engl J Med. 2014 Jun 26;370(26):2467-77. doi: 10.1056/NEJMoa1311376. PMID: 24963566.

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Ambulatory Cardiac Monitors (Excluding Holter Monitors)

International Society for Holter and Noninvasive Electrocardiology (ISHNE) and Heart Rhythm Society (HRS). Steinberg JS, Varma N, Cygankiewicz I, Aziz P, Balsam P, Baranchuk A, Cantillon DJ, Dilaveris P, Dubner SJ, El-Sherif N, Krol J, Kurpesa M, La Rovere MT, Lobodzinski SS, Locati ET, Mittal S, Olshansky B, Piotrowicz E, Saxon L, Stone PH, Tereshchenko L, Turitto G, Wimmer NJ, Verrier RL, Zareba W, Piotrowicz R. 2017 ISHNE-HRS expert consensus statement on ambulatory ECG and external cardiac monitoring/telemetry. Ann Noninvasive Electrocardiol. 2017 May;22(3). doi:10.1111/anec.12447. PMID: 28480632.

Kaura A, Sztriha L, Chan FK, Aeron-Thomas J, Gall N, Piechowski-Jozwiak B, Teo JT. Early prolonged ambulatory cardiac monitoring in stroke (EPACS): an open-label randomised controlled trial. Eur J Med Res. 2019 Jul 26;24(1):25.

Khan M, Miller DJ. Detection of paroxysmal atrial fibrillation in stroke/tia patients. Stroke Res Treat. 2013;2013: 840265. doi: 10.1155/2013/840265. Epub 2013 Mar 26. PMID: 23662246.

Locati ET, Vecchi AM, Varqiu S, Cattafi G, Lunati M. Role of extended external loop recorders for the diagnosis of unexplained syncope, pre-syncope, and sustained palpitations. Europace. 2014 Jun;16(6):914-22. doi: 10.1093/europace/eut337. Epub 2013 Oct 24. doi: 10.1093/europace/eut337. PMID: 24158255.

Madias C. Ambulatory ECG Monitoring. UpToDate. 2020 Mar 11. Accessed at: https://www.uptodate.com/contents/ambulatory-ecg-monitoring

Miller DJ, Khan MA, Schultz LR, Simpson JR, Katramados AM, Russman AN, Mitsias PD. Outpatient cardiac telemetry detects a high rate of atrial fibrillation in cryptogenic stroke. J Neurol Sci. 2013 Jan 15;324(1-2):57-61. doi: 10.1016/j.jns.2012.10.001. Epub 2012 Oct 24. PMID: 23102659.

Mullis AH, Ayoub K, Shah J, Butt M, Suffredini J, Czarapata M, Delisle B, Ogunbayo GO, Darrat Y, Elayi CS. Fluctuations in premature ventricular contraction burden can affect medical assessment and management. Heart Rhythm. 2019 Oct;16(10):1570-4. doi: 10.1016/j.hrthm.2019.04.033. Epub 2019 Apr 18. PMID: 31004780.

National Institute for Health and Care Excellence (NICE). Atrial fibrillation: management. Clinical Guideline (CG180). 2014 Jun 18. Last Updated 2014 Aug 1. Accessed at: https://www.nice.org.uk/guidance/cg180

National Institute for Health and Care Excellence (NICE). Zio Service for detecting cardiac arrhythmias. Medtech innovation briefing (MIB101). 2017 Mar 28. Accessed at: https://www.nice.org.uk/advice/mib101

New Hampshire Department of Health and Human Services. Billing Manuals. Accessed at: https://nhmmis.nh.gov/portals/wps/portal/BillingManuals

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

New Hampshire Department of Health and Human Services. Provider Notices. Accessed at: https://www.dhhs.nh.gov/ombp/pharmacy/notices.htm

Prabhakaran S, Elkind MSV. Cryptogenic Stroke. UpToDate. 2020 Feb 14. Accessed at: http://www.uptodate.com/contents/cryptogenic-stroke

Rosenberg MA, Samuel M, Thosani A, Zimetbaum PJ. Use of a noninvasive continuous monitoring device in the management of atrial fibrillation: a pilot study. Pacing Clin Electrophysiol. 2013 Mar;36(3):328-33. Published online 2012 Dec 13. doi: 10.1111/pace.12053. PMID: 23240827.

Rothman SA, Laughlin JC, Seltzer J, Walia JS, Baman RI, Siouffi SY, Sangrigoli RM, Kowey PR. The diagnosis of cardiac arrhythmias: a prospective multi-center randomized study comparing mobile cardiac outpatient telemetry versus standard loop event monitoring. J Cardiovasc Electrophysiol. 2007 Mar;18(3):241-7. PMID: 17318994.

Saarel EV, Stefanelli CB, Fischbach PS, Serwer GA, Rosenthal A, Dick M 2nd. Transtelephonic electrocardiographic monitors for evaluation of children and adolescents with suspected arrhythmias. Pediatrics. 2004 Feb;113(2):248–51. PMID: 14754934.

Salerno JC. Causes of syncope in children and adolescents. UpToDate. 2019 Oct 8.

Sanna T, Diener HC, Passman RS, Lazzaro VD, Bernstein RA, Morillo CA, Rymer MM, Thijs V, Rogers T, Beckers F, Lindborg K, Brachman J. CRYSTAL AF Investigators. Cryptogenic Stroke and Underlying Atrial Fibrillation. N Engl J Med. 2014 Jun 26;370(26):2478-86. doi: 10.1056/NEJMoa1313600. PMID: 24963567.

Schreiber D, Sattar A, Drigalla D, Higgins S. Ambulatory cardiac monitoring for discharged emergency department patients with possible cardiac arrhythmias. West J Emerg Med. 2014 Mar;15(2):194-8. doi: 10.5811/westjem.2013.11.18973. PMID: 24672611.

Silveira I, Sousa MJ, Antunes N, Silva V, Roque C, Pinheiro-Vieira A, Lagarto V, Hipólito-Reis A, Luz A, Torres S. Efficacy And Safety Of Implantable Loop Recorder: Experience Of A Center. J Atr Fibrillation. 2016 Aug 31;9(2):1425. doi: 10.4022/jafib.1425. eCollection 2016 Aug-Sep. PMID: 27909534.

Solbiati M, Casazza G, Dipaola F, Barbic F, Caldato M, Montano N, Furlan R, Sheldon RS, Costantino G. The diagnostic yield of implantable loop recorders in unexplained syncope: A systematic review and meta-analysis. Int J Cardiol. 2017 Mar 15;231:170-176. doi: 10.1016/j.ijcard.2016.12.128. Epub 2016 Dec 22. PMID: 28052814.

Steinhubl SR, Waalen J, Edwards AM, Ariniello LM, Mehta RR, Ebner GS, Carter C, Baca-Motes K, Felicione E, Sarich T, Topol EJ. Effect of a Home-Based Wearable Continuous ECG Monitoring Patch on Detection of Undiagnosed Atrial Fibrillation: The mSToPS Randomized Clinical Trial. JAMA. 2018 Jul 10;320(2):146-155. doi: 10.1001/jama.2018.8102. PMID: 29998336. Ambulatory Cardiac Monitors (Excluding Holter Monitors)

Subbiah R, Chia PL, Gula LJ, Klein GJ, Skanes AC, Yee R, Krahn AD. Cardiac Monitoring in Patients with Syncope: Making that Elusive Diagnosis. Curr Cardiol Rev. 2013 Nov; 9(4):299-307. Published online 2013 Nov. doi: 10.2174/1573403X10666140214120056. PMID: 23228074.

Tsang JP, Shunmugam M. Benefits of monitoring patients with mobile cardiac telemetry (MCT) compared with the event or Holter monitors. Medical Devices (Auckl.) 2014;7:1–5. doi: 10.2147/MDER.S54038. PMID: 24353449.

Tung CE, Su D, Turakhia MP, Lansberg MG. Diagnostic yield of extended cardiac patch monitoring in patients with stroke or TIA. Front Neurol. 2015 Jan 12;5:266. doi: 10.3389/fneur.2014.00266. eCollection 2014. PMID: 25628595.

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Policy History Original Effective Original Approval Original Policy Date* and Version Policy Owner Date Approved by Number Regulatory Approval: N/A 05/09/06 Medical Policy Manager Quality and Clinical Version 1 as Chair of Medical Policy, Management Committee Internal Approval: Criteria, and Technology (Q&CMC) 05/09/06 Assessment Committee (MPCTAC) *Effective Date for the BMC HealthNet Plan Commercial Product(s): 01/01/12 *Effective Date for the Well Sense Health Plan New Hampshire Medicaid Product(s): 01/01/13 *Effective Date for the Senior Care Options Product(s): 01/01/16

Policy title was Ambulatory Cardiac Event Monitors (Excluding Holter Monitors) from 05/09/06 to 01/31/17. Policy title changed to Ambulatory Cardiac Monitors (Excluding Holter Monitors) as of 02/01/17; as of 02/01/17 this policy includes mobile cardiac outpatient telemetry (after retiring the Mobile Cardiac Outpatient Telemetry medical policy, policy number OCA 3.356, as of 01/31/17).

Policy Revisions History Revision Effective Date Review Date Summary of Revisions Approved by and Version Number 04/24/07 Added coding and references. Version 2 04/24/07: Utilization Management Committee (UMC) 05/03/07: Quality Improvement Committee (QIC) 04/08/08 No changes. Version 3 04/08/08: MPCTAC 04/22/08: UMC Ambulatory Cardiac Monitors (Excluding Holter Monitors)

Policy Revisions History 04/25/08: QIC 04/15/09 Clarified prior authorization for Version 4 05/26/09: MPCTAC ambulatory event monitors. 05/26/09: UMC 06/24/09: QIC 05/01/10 Updated clinical criteria and coding, Version 5 05/25/10: MPCTAC clinical information and references. 06/23/10: QIC 05/01/11 Updated references and coding, added Version 6 05/18/11: MPCTAC specific limitations that are considered 06/22/11: QIC investigational and updated the title. 05/01/12 Annual review, no changes made to Version 7 05/16/12: MPCTAC clinical criteria, CPT code definitions 06/27/12: QIC and references updated. 07/30/12 Off cycle review for Well Sense Health Version 8 08/13/12: MPCTAC Plan, deleted reference to ‘eligible’ 09/13/12: QIC members, revised the introductory paragraph in Applicable Coding section, revised code list headings, updated code list. 12/01/12 Revised applicable code list, updated Version 9 12/19/12: MPCTAC references, and revised language in 01/31/13: QIC Description of Item or Service section. Referenced Plan’s Experimental and Investigational Treatment policy, Mobile Cardiac Outpatient Telemetry policy, and Medically Necessary policy. Reformatted criteria in Medical Policy Statement section. Added limitations for repeat studies within one year and for new and emerging technology. Added documentation in Clinical Background Information section related to new technology. Changed name of policy category from “Clinical Coverage Guidelines” to “Medical Policy.” 12/01/13 Review of effective date 02/01/14. 02/01/14 12/18/13: MPCTAC Referenced near syncope in the Version 10 01/21/14: QIC Description of Item or Service and Definitions sections. Clarified external vs. implantable devices in Description of Item or Service section and Medical Policy Statement section without changing criteria. Updated References and Summary sections. Revised text in Limitations section without changing

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

Policy Revisions History criteria. 12/01/14 Review for effective date 05/01/15. 05/01/15 12/17/14: MPCTAC Revised criteria in the Medical Policy Version 11 01/14/15: QIC Statement and Limitations sections. Updated Definitions and References sections. 10/01/15 Review for effective date 12/01/15. 12/01/15 10/21/15: MPCTAC Updated list of applicable products and Version 12 11/11/15: QIC corresponding notes. Clarified text in the Description of Item or Service section. Updated references. 11/25/15 Review for effective date 01/01/16. 01/01/16 11/25/15: MPCTAC Revised language in the Applicable Version 13 (electronic vote) Coding section. 12/09/15: QIC 10/01/16 Review for effective date 02/01/17. 02/01/17 10/19/16: MPCTAC Revised policy title. Included mobile Version 14 11/09/16: QIC cardiac outpatient telemetry (MCOT), single-use ambulatory ECG monitors, and self-monitoring ECG technologies in the policy (retiring the Mobile Cardiac Outpatient Telemetry medical policy, policy number OCA 3.356 as of 01/31/17). Revised Policy Summary, Description of Item or Service, Definitions, Clinical Background Information, References, and References to Applicable Laws and Regulations sections. Revised criteria in the Medical Policy Statement and Limitations sections, adding criteria for medically necessary indications for MCOT. Revised the applicable code list to include additional services. Added Plan notes to the coding section. 10/01/17 Review for effective date 11/01/17. 11/01/17 10/18/17: MPCTAC Updated Policy Summary and Version 15 References sections. Administrative changes made to the Limitations section. 12/01/17 Review for effective date 01/01/18. 01/01/18 Not applicable because Industry-wide updates to codes Version 16 industry-wide code included in the Applicable Coding changes. section. Administrative changes made to the Limitations section (clarifying

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

Policy Revisions History criteria already included in the Medical Policy Statement section). 02/01/18 Review for effective date 03/01/18. 03/01/18 02/21/18: MPCTAC Administrative changes made to the Version 17 Policy Summary, Description of Item or Service, Medical Policy Statement, Limitations, and Other Applicable Policies sections. 10/01/18 Review for effective date 01/01/19. 01/01/19 10/17/18: MPCTAC Administrative changes made to the Version 18 Policy Summary, Description of Item or Service, Clinical Background Information, References, and Other Applicable Policies sections. Revised criteria in the Medical Policy Statement and Limitations sections to include the use of prescribed single-use external ambulatory ECG monitoring patches as medically necessary for continuous cardiac monitoring when applicable criteria are met. Revised code list and Plan notes related to coding in the Applicable Coding section. 12/01/18 Review for effective date 01/01/19. 01/01/19 12/19/18: MPCTAC Industry-wide updates made to the Version 19 code list in the Applicable Coding section for services included in the policy (with corresponding medical necessity criteria). 06/01/19 Review for effective date 09/01/19. 09/01/19 06/19/19: MPCTAC Administrative changes made to the Version 20 Limitations and References sections. Criteria revised in the Medical Policy Statement section. 09/01/19 Review for effective date 10/01/19. 10/01/19 09/18/19: MPCTAC Administrative changes made to the Version 21 References and Reference to Applicable Laws and Regulations sections. 10/01/19 Review for effective date 01/01/20. 01/01/20 10/04/19: MPCTAC Updated the applicable code list. Version 22 (electronic vote) 09/01/20 Review for effective date 10/12/20. 10/01/20 09/16/20: MPCTAC Administrative changes made to the Version 23 References and Other Applicable Policies sections. CPT codes 0497T and

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

Policy Revisions History 0498T removed from the Applicable Coding section because these two codes are not payable for any Plan products. 12/01/20 Review for effective date 03/01/21. 03/01/21 12/16/20: MPCTAC Industry-wide code updates in the Version 24 Applicable Coding section. Updated the References section. Revised criteria in the Limitations section.

Last Review Date 12/01/20

Next Review Date 09/01/21

Authorizing Entity MPCTAC

Other Applicable Policies Medical Policy - Experimental and Investigational Treatment, policy number OCA 3.12 Medical Policy - Medically Necessary, policy number OCA 3.14 Reimbursement Policy - General Billing and Coding Guidelines, policy number 4.31 Reimbursement Policy - General Billing and Coding Guidelines, policy number SCO 4.31 Reimbursement Policy - General Billing and Coding Guidelines, policy number WS 4.17 Reimbursement Policy - General Clinical Editing and Payment Accuracy Review Guidelines, policy number 4.108 Reimbursement Policy - General Clinical Editing and Payment Accuracy Review Guidelines, policy SCO 4.108 Reimbursement Policy - General Clinical Editing and Payment Accuracy Review Guidelines, policy number WS 4.18 Reimbursement Policy - Hospital, policy number WS 4.21 Reimbursement Policy - Inpatient Hospital, policy number 4.110 Reimbursement Policy - Inpatient Hospital, policy number SCO 4.110 Reimbursement Policy - Non-Participating Provider, policy number SCO 4.5 Reimbursement Policy - Non-Participating Provider, policy number WS 4.5 Reimbursement Policy - Non-Reimbursed Codes, policy number 4.38 Reimbursement Policy - Non-Reimbursed Codes, policy number WS 4.38 Ambulatory Cardiac Monitors (Excluding Holter Monitors)

Reimbursement Policy - Outpatient Hospital, policy number 4.17 Reimbursement Policy - Outpatient Hospital, policy number SCO 4.17 Reimbursement Policy - Physician and Non Physician Practitioner Services, policy number 4.608 Reimbursement Policy - Physician and Non Physician Practitioner Services, policy number SCO 4.608 Reimbursement Policy - Physician and Non Physician Practitioner Services, policy number WS 4.28 Reimbursement Policy - Professional Bilateral and Multiple Procedure Reductions, policy number WS 4.24 Reimbursement Policy - Provider Preventable Conditions and Serious Reportable Events, policy number 4.610 Reimbursement Policy - Provider Preventable Conditions and Serious Reportable Events, policy number SCO 4.610 Reimbursement Policy - Provider Preventable Conditions and Serious Reportable Events, policy number WS 4.29

Reference to Applicable Laws and Regulations 21 CFR 807. Code of Federal Regulations. Food and Drugs. Food and Drug Administration. Department of Health and Human Services. Medical Devices. Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices.

42 CFR § 405 and § 414. Code of Federal Regulations. Centers for Medicare & Medicaid Services (CMS). Medicare Program. Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies.

42 CFR § 405.1060. Code of Federal Regulations. Applicability of National Coverage Determinations.

42 CFR § 414. Centers for Medicare & Medicaid Services (CMS). Medicare Program. Payment for Part B Medical and Other Health Services.

42 USC §18001 (2010). Patient Protection and Affordable Care Act.

78 FR 48164. Federal Register. Centers for Medicare & Medicaid Services (CMS). Medicare Program. Revised Process for Making National Coverage Determinations. 2013 Aug 7.

80 FR 81673. Federal Register. Centers for Medicare & Medicaid Services (CMS). Medicare Program. Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies.

114.3 CMR 17.00. Code of Massachusetts Regulations. Division of Health Care Finance and Policy. Medicine.

130 CMR. Code of Massachusetts Regulations. Division of Medical Assistance.

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

211 CMR 52.00. Code of Massachusetts Regulations. Division of Insurance. Managed Care Consumer Protections and Accreditation of Carriers.

Commonwealth of Massachusetts. General Laws. Accessed at: https://malegislature.gov/Laws/GeneralLaws

Commonwealth of Massachusetts. Massachusetts General Laws Mandating that Certain Health Benefits Be Provided By Commercial Insurers, Blue Cross and Blue Shield and Health Maintenance Organizations. Regulatory Citations. 2017 Oct 24. Accessed at: https://www.mass.gov/files/documents/2017/10/27/mndatben.pdf

Commonwealth of Massachusetts. Massachusetts Law about Insurance. A Compilation of Laws, Regulations, and Web Sources on Insurance Law in General. Accessed at: https://www.mass.gov/info- details/massachusetts-law-about-insurance#massachusetts-laws-

He-W 500. New Hampshire Code of Administrative Rules. Medical Assistance.

He-W 531. New Hampshire Code of Administrative Rules. Medical Assistance. Physician Services.

He-W 543. New Hampshire Code of Administrative Rules. Medical Assistance. Hospital Services.

New Hampshire Department of Health and Human Services (DHHS). Certified Administrative Rules. Accessed at: https://www.dhhs.nh.gov/oos/bhfa/rules.htm

RSA 420-E. New Hampshire Revised Statutes Annotated. Insurance. Licensure of Medical Utilization Review Entitles.

Disclaimer Information: + Medical Policies are the Plan’s guidelines for determining the medical necessity of certain services or supplies for purposes of determining coverage. These Policies may also describe when a service or supply is considered experimental or investigational, or cosmetic. In making coverage decisions, the Plan uses these guidelines and other Plan Policies, as well as the Member’s benefit document, and when appropriate, coordinates with the Member’s health care Providers to consider the individual Member’s health care needs. Plan Policies are developed in accordance with applicable state and federal laws and regulations, and accrediting organization standards (including NCQA). Medical Policies are also developed, as appropriate, with consideration of the medical necessity definitions in various Plan products, review of current literature, consultation with practicing Providers in the Plan’s service area who are medical experts in the particular field, and adherence to FDA and other government agency policies. Applicable state or federal mandates, as well as the Member’s benefit document, take precedence over these guidelines. Policies are reviewed and updated on an annual basis, or more frequently as needed. Treating providers are solely responsible for the medical advice and treatment of Members. The use of this Policy is neither a guarantee of payment nor a final prediction of how a specific claim(s) will be adjudicated. Reimbursement is based on many factors, including member eligibility and benefits on the date of service; medical

Ambulatory Cardiac Monitors (Excluding Holter Monitors)

necessity; utilization management guidelines (when applicable); coordination of benefits; adherence with applicable Plan policies and procedures; clinical coding criteria; claim editing logic; and the applicable Plan – Provider agreement.

Ambulatory Cardiac Monitors (Excluding Holter Monitors)