MP-05 Cardiac Monitoring Devices Form

Medical Policy Cardiac Monitoring Devices Page 1

Policy Number: MP-05 Current Effective Date: 12/13/2019 Original Effective Date: 7/1/2017 Next Review/Revision Date: 12/1/2020 Plans: QUEST Integration (Medicaid) & AlohaCare Advantage Plus Special Needs Plan (Medicare)

1. Purpose 1.1 The purpose of this policy is to define medically necessary indications for outpatient cardiac monitoring devices.
2. Policy 2.1 Various devices are available for outpatient cardiac rhythm monitoring. These devices can be continuous, intermittent, or real-time. The period of time they can monitor ranges from 24 hours to 30 days or more. It is important that the type and time period of monitoring is appropriate for the diagnostic or prognostic needs for the individual patient. 2.2 The rate of detection of arrhythmias and atrial fibrillation (AF) using ambulatory cardiac monitoring devices is low. Monitoring for longer than 48 hours increases the detection rate for patients who have events less frequently than daily. However higher detection rates do not necessarily improve patient outcomes. There is sufficient evidence to support the clinical utility of outpatient cardiac monitoring devices in the evaluation of symptoms suggestive of arrhythmias (eg, syncope, palpitations), and to detect AF in patients who have undergone cardiac ablation of AF or who have a history of cryptogenic stroke.
3. Definitions 3.1 Continuous Recorders– A device that records an electrocardiogram (EKG) tracing continuously.
   After recording, the device is removed, the recording is analyzed, and a report of the heart’s activity is generated. a Holter Monitor – records for 24-48 hours. This type of recording may be of reasonable diagnostic yield in patients whose symptoms (syncope, palpitations) occur frequently. b Continuous recording devices with longer recording periods (example Zio) - Devices continuously worn and continuously record and store data longer than traditional Holter (up to 14 days). When cardiac events are strongly suspected but symptoms occur too infrequently for capture with a Holter Monitor, a device with a longer recording period may be considered. 3.2 Intermittent Recorders (e.g., event recorder, loop recorder) - A device typically left in place for 30 calendar days or longer. Implanted devices may retain capacity to record for two to three years.
   When cardiac events are strongly suspected but symptoms occur too infrequently for capture with a Holter Monitor, an intermittent recorder may be considered. These devices may be external, or implanted. Both external and implanted may have a patient triggered, or auto triggered mechanism. a Pre-symptom memory loop - Loop recorders capture a predetermined length of cardiac rhythm both before and after activation. These may have a button that the wearer presses upon detecting symptoms or an auto-trigger feature that does not require patient activation. b Post-symptom (no memory loop) - Post-symptom event recorders do not require electrodes to be attached to the body. When symptoms occur, the patient places the recording device

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against the chest and activates it by pressing a button. It does not have a memory loop and the heart rhythm is only recorded subsequent to activation. The data may be transmitted telephonically. 3.3 Outpatient/Mobile Cardiac Telemetry (Real-time Heart Monitors) - A real time cardiac surveillance system is an automatically activated device that requires no patient intervention to either capture or transmit an arrhythmia when it occurs. The patient wears a portable electrocardiogram (ECG) sensor for continuous monitoring, 24 hours per day, providing cardiac surveillance with automatic rapid notification of rhythm abnormalities. Real-time heart monitors can function through home-based surveillance, or mobile/wearable cardiac telemetry (MCT) surveillance. In either case, receiving centers are staffed by certified cardiac technicians 24 hours per day, and the physician is notified of ECG abnormalities within minutes of an abnormality occurring allowing for timely intervention. a Home Based - The sensors transmit signals via telephone when the patient is within the range of a nearby base station. Upon arrhythmia detection, the device transmits the ECG wave to the receiving center. b Mobile Cardiac Telemetry - The sensors transmit the ECG to a computer with modem where the real-time analysis occurs. When the ECG violates certain alarm limits, the ECG strip is automatically sent to the receiving center via the computer modem or wireless communication from any location where wireless services are available. 3.4 Palpitations - a perceived irregularity in heart rhythm, often described as fluttering or skipping. 3.5 Presyncope (aka near syncope) - an episode of near-fainting or a sign of impending loss of consciousness. Symptoms include, but are not limited to, dizziness, lightheadedness, blurred vision, and general unsteadiness. 3.6 Syncope - the transient loss of consciousness and postural tone caused by diminished cerebral blood flow. It is characterized by rapid onset, short duration, and spontaneous complete recovery. 3.7 Tachycardia - a heart rate greater than 100 beats per minute at rest or with limited (minimal) activity.

4. Procedure 4.1 A Holter monitor for 24 to 48 hours is covered without prior authorization for evaluation of any of the following unexplained symptoms occurring on a daily or near daily basis: a. Palpitations; or b. Unexplained dizziness; or c. Syncope or near syncope. 4.2 Alternatives to Holter monitoring, including continuous monitors that record and store information for periods longer than 48 hours, or intermittent recorders require prior authorization. a. The external ambulatory event monitors are covered as an alternative to Holter monitors for any of the following:
5. Infrequent, unexplained symptoms (less frequently than 48 hours) suggestive of cardiac arrhythmia, such as: o Palpitations; or o Dizziness; or o Presyncope; or o Syncope; or

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2. Cryptogenic stroke with negative standard workup for atrial fibrillation which may include previous negative Holter monitor; or
3. Post ablation of atrial fibrillation when discontinuation of anticoagulation is being considered. b. Implantable memory loop recorders are covered if ordered by a cardiologist; and any of the above criteria (1.a, b, or c) is met, or Holter monitor was non-diagnostic.
4. Limitations 5.1 The following are not covered: a. Outpatient cardiac monitoring for:
5. patients in whom the cause is known, or has been identified through history, physical exam, ecg or standard laboratory testing.
6. Screening for asymptomatic patients; b. Real-time outpatient mobile cardiac telemetry (MCT), as it has not been shown to result in superior patient outcomes than the devices described above; c. Self‐monitoring devices (not prescribed by a physician) such as a combination device which includes a ECG monitor combined with a cellular telephone or other personal electronic device; d. Additional software or hardware required for downloading ECG data to a device such as a personal computer, smart phone, or tablet. e. Ambulatory event monitors are considered experimental and of unproven benefit for:
7. Detecting myocardial ischemia by detecting ST segment changes
8. Monitoring effectiveness of antiarrhythmic therapy

9. Coding Information The following medical codes are relevant codes for diagnosis and procedures for Cardiac Monitoring Devices and for informational purposes only. All the medical codes listed in this policy do not constitute or imply benefit coverage or provider reimbursement. ICD‐10‐CM Description R00.2 Palpitations R42 Dizziness and giddiness R55 Syncope and collapse I48.0 Paroxysmal atrial fibrillation

   HCPCS/CPT Description 0295T External electrocardiographic recording for more than 48 hours up to 21 days by continuous rhythm recording and storage; includes recording, scanning analysis with report, review and interpretation 0296T External electrocardiographic recording for more than 48 hours up to 21 days by continuous rhythm recording and storage; recording (includes connection and initial recording) 0297T External electrocardiographic recording for more than 48 hours up to 21 days by continuous rhythm recording and storage; scanning analysis with report

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0298T External electrocardiographic recording for more than 48 hours up to 21 days by continuous rhythm recording and storage; review and interpretation 33285 Insertion, subcutaneous cardiac rhythm monitor, including programming 33286 Removal, subcutaneous cardiac rhythm monitor 93224 External electrocardiographic recording up to 48 hours by continuous rhythm recording and storage; includes recording, scanning analysis with report, review and interpretation by a physician or other qualified health care professional 93225 External electrocardiographic recording up to 48 hours by continuous rhythm recording and storage; recording (includes connection, recording, and disconnection) 93226 External electrocardiographic recording up to 48 hours by continuous rhythm recording and storage; scanning analysis with report 93227 External electrocardiographic recording up to 48 hours by continuous rhythm recording and storage; review and interpretation by a physician or other qualified health care professional 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 93229 ; 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 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 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) 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 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 93285 Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional; subcutaneous cardiac rhythm monitor system 93290 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

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system, including analysis of 1 or more recorded physiologic cardiovascular data elements from all internal and external sensors 93291 Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter; subcutaneous cardiac rhythm monitor system, including heart rhythm derived data analysis 93297 Interrogation device evaluation(s), (remote) up to 30 days; implantable cardiovascular physiologic monitor system, including analysis of 1 or more recorded physiologic cardiovascular data elements from all internal and external sensors, analysis, review(s) and report(s) by a physician or other qualified health care professional 93298 Interrogation device evaluation(s), (remote) up to 30 days; subcutaneous cardiac rhythm monitor system, including analysis of recorded heart rhythm data, analysis, review(s) and report(s) by a physician or other qualified health care professional 93299 Interrogation device evaluation(s), (remote) up to 30 days; implantable cardiovascular physiologic monitor system or subcutaneous cardiac rhythm monitor system, remote data acquisition(s), receipt of transmissions and technician review, technical support and distribution of results C1764 Event recorder, cardiac (implantable)

Not covered: Description 0497T External patient-activated, physician- or other qualified health care professional- prescribed, electrocardiographic rhythm derived event recorder without 24 hour attended monitoring; in-office connection 0498T External patient-activated, physician- or other qualified health care professional-prescribed, electrocardiographic rhythm derived event recorder without 24 hour attended monitoring; review and interpretation by a physician or other qualified health care professional per 30 days with at least one patient-generated triggered event

7. References/Resources 7.1 Crawford MH, Bernstein SJ, Green LA, et al. ACC/AHA Guidelines for Ambulatory Electrocardiography. A Report of the American College of Cardiology/American Heart Association Task Force of Practice Guidelines (Committee to Revise the Guidelines for Ambulatory Electrocardiography). J Am Coll Cardiol. 1999 Sept; 34(3):912-948 https://www.sciencedirect.com/science/article/pii/S073510979900354X?via%3Dihub 7.2 Agency for Healthcare Research and Quality (AHRQ). Technology Assessment Program: Remote Cardiac Monitoring. Prepared by ECRI Institute. Issued: December 12, 2007 http://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id51ta.pdf 7.3 Pevnick JM, Birkeland K, Zimmer R, et al. Wearable technology for cardiology: An update and framework for the future. Trends Cardiovasc Med. 2018 Feb;28(2):144-150. doi: 10.1016/j.tcm.2017.08.003. Epub 2017 Aug 9 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5762264/pdf/nihms898743.pdf

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7.4 Shen WK, Sheldon RS, Benditt DG, et.al. 2017 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope J Am Coll Cardiol. 2017 Aug, 70 (5) e39-e110 http://www.onlinejacc.org/content/70/5/e39?_ga=2.47639655.17065192.1573008188- 511133694.1573008188 7.5 National Institute for Health and Clinical Excellence (NICE), Transient loss of consciousness ('blackouts') management in adults and young people. Clinical Guideline 109. 2010, reaffirmed 3/2019 https://www.nice.org.uk/guidance/cg109 7.6 Centers for Medicare and Medicaid Services (CMS): National Coverage Determination (NCD) No. 20.15 - Electrocardiographic services. Effective August 26, 2004. http://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=179&ncdver=2&DocID=20.15&SearchType=Advanced&bc=IAAAAAgAA AAAAA%3d%3d& 7.7 Culebras A, Messe SR, Chaturvedi S, et al. Summary of evidence-based guideline update: prevention of stroke in nonvalvular atrial fibrillation: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. Feb 25 2014;82(8):716-724. PMID 24566225 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3945662/ 7.8 Steinberg JS, Varma N, Cygankiewicz I, et al. 2017 ISHNE-HRS expert consensus statement on ambulatory ECG and external cardiac monitoring/telemetry. Heart Rhythm. Jul 2017;14(7):e55- e96. PMID 28495301 https://www.heartrhythmjournal.com/article/S1547-5271(17)30415-0/fulltext

8. Review/Revision History 7/1/2017 – New policy 10/21/2019 -- New template, updated references, removed PA requirement for Holter, add PA for insertion & programming, and for HCPCS code for device. 12/1/2020 - Retired