L29253-LCD

Automated World Health

Local Coverage Determination (LCD) for Patient Demand Single or

Multiple Event Recorder (L29253)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29253

LCD Title Patient Demand Single or Multiple Event Recorder

Primary Geographic Jurisdiction Florida

Contractor's Determination Number 93268

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/02/2009

Original Determination Ending Date ANTICIPATED 10/08/2012

Revision Effective Date

For services performed on or after 03/01/2012 Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations, Chapter 1, Section 20.15 Change Request 7121, (Transmittal 2037), dated August 27, 2010

Indications and Limitations of Coverage and/or Medical Necessity

Ambulatory electrocardiography (AECG) refers to services rendered in an outpatient setting over a specified period of time, generally while a patient is engaged in daily activities, including sleep. AECG devices are intended to provide the physician with documented episodes of arrhythmia, which may not be detected using a standard 12-lead EKG. AECG is most typically used to evaluate symptoms that may correlate with intermittent cardiac arrhythmias and/or myocardial ischemia. Such symptoms include syncope, dizziness, chest pain, palpitations, or shortness of breath. Additionally, AECG is used to evaluate patient response to initiation, revision, or discontinuation of arrhythmic drug therapy.

An event recorder is a portable unit, attached to a patient, which permits the patient to record an EKG rhythm strip at the onset of symptoms (e.g., syncope, dizziness) or in response to a physician’s order (e.g., immediately following strong physical exertion). Most devices also permit the patient to simultaneously voice-record in order to describe the symptoms and/or activity concurrently. There are two basic types of event recorders (postevent and preevent), which are differentiated on the basis of memory.

When the goal is to correlate the patient’s rhythm or EKG pattern with symptoms that are very infrequent (at weekly intervals or more), the patient activated event recorder is the optimal choice. However, if the patient’s symptoms are of such brief duration (seconds) or severity (frank syncope) to preclude capture by such a unit, then a loop event recorder is required. It is important to correlate an abnormal rate and rhythm with cardiovascular symptomatology and determine the precise mechanism of the arrhythmia.

Medicare will consider the use of patient demand single or multiple event recorders medically reasonable and necessary under the following circumstances:

• When indicated for the detection, characterization, and documentation of symptomatic transient arrhythmias, when the frequency of the symptoms is limited and use of a 24-hour ambulatory EKG is unlikely to capture and document the arrhythmia.

• A definitive diagnosis has not been made after all of the following conditions have been met:

The patient has undergone a complete history and physical by a physician prior to the initiation of monitoring. The history and physical must indicate that the patient is experiencing recurrent, transient symptoms suggestive of cardiac arrhythmia Note: Palpitations are extremely common in healthy individuals. Therefore, if ICD-9 code

785.1 (Palpitations) is billed as the diagnosis supporting medical necessity, the history and physical or other pertinent medical record documentation must support the presence of associated symptoms such as dizziness, shortness of breath, chest discomfort, or an underlying history of cardiac disease; and

The patient has undergone a 12 lead EKG and rhythm strip.

• A physician overseeing the medical management of the patient orders the medically necessary patient demand event recorder.

• Any device used for event recording must be FDA approved for the indication for which it is being utilized.

• The FDA approved device must be capable of transmitting EKG leads I, II, or III (the standard limb leads). To generate a sufficient EKG rhythm strip, the device must either have “built in” electrodes, such that placement of the device on the patient’s precordium produces an EKG reading of lead I, II, or III, or the device involves the proper placement/attachment of at least two electrodes to the patient. Because it is not practical to attach electrodes to the arms and legs, modifications of the standard limb leads must be utilized. Electrode placement for the monitor limb leads is similar to standard placement, except that the left and right shoulder or subclavian areas and the lower left quadrant of the abdomen are used for electrode placement. The following are the sites for proper lead placement to generate a lead I, II, or III:

LEAD / + ELECTRODE / - ELECTRODE:

I / Lt. subclavian (shoulder) / Rt. subclavian (shoulder)

II / Lt. lower quadrant abdomen / Rt. subclavian (shoulder) III / Lt. lower quadrant abdomen / Lt. subclavian (shoulder)

• The transmission of the EKG lead I, II, or III must be sufficiently comparable to readings obtained by conventional EKG to permit proper interpretation of abnormal cardiac rhythms. EKG tracings normally consist of three identifiable waveforms: the P wave (depicting atrial depolarization), the QRS complex (depicting ventricular depolarization), and the T wave (depicting ventricular repolarization). The lead II rhythm strip depicts the heart’s rhythm more clearly than any other waveform.

• A provider of the service must be capable of receiving and recording transmissions 24-hours per day, every day of the year. This is applicable to those HCPCS codes whose descriptor indicates “24-hour attended monitoring” This includes receipt of the EKG signal, as well as the voice transmission relating any associated symptoms.

• The designated monitoring facility must have on-site 24-hour availability of an attendant trained in equipment operation and on-line analysis of the transmitted EKG tracing when HCPCS codes requiring 24-hour attended monitoring are ordered.

• The transmissions must be received by a person capable of responding to the transmission. The transmission is not to be received by an answering machine for review at a later time when HCPCS codes requiring 24-hour attended monitoring are ordered.

• The person receiving the transmission must be a technician, nurse, or physician trained in interpreting EKGs and abnormal rhythms. A physician must be available for immediate consultation to review the transmission, in case of significant symptoms or EKG abnormalities, when HCPCS codes requiring 24-hour attended monitoring are ordered.

• A provider of the service must be capable of immediately notifying the patient’s attending physician when indicated. The referring physician’s telephone number and other emergency instructions for the patient should be included in the referral for the monitoring services.

• The recording device and transmission equipment must be verifiably in the patient’s possession for the entire thirty day period of submission.

• The patient must be instructed in and capable of facile operation of both the recording device and the transmission device. Therefore, the patient must not be limited by a medical condition that would indicate that the patient is incapable of the proper operation of the device (e.g., a patient with senile dementia, OBS, Alzheimers, mental retardation, etc.). If a responsible party is required to assist the patient in the device operation and transmissions, that party must be present on a 24-hour basis. The instructions regarding the operation of the device, changing the batteries, etc. must be given by the provider of the monitoring service to the patient/responsible party prior to initiation of use of the patient demand event recorder.

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

999x Not Applicable

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

99999 Not Applicable

CPT/HCPCS Codes

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, PHYSICIAN REVIEW AND INTERPRETATION

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; PHYSICIAN REVIEW AND

INTERPRETATION

ICD-9 Codes that Support Medical Necessity

427.81 - 427.89 SINOATRIAL NODE DYSFUNCTION - OTHER SPECIFIED CARDIAC DYSRHYTHMIAS

427.9 CARDIAC DYSRHYTHMIA UNSPECIFIED

780.2 SYNCOPE AND COLLAPSE

780.4 DIZZINESS AND GIDDINESS

785.1 PALPITATIONS

786.09 RESPIRATORY ABNORMALITY OTHER

786.50 - 786.59 UNSPECIFIED CHEST PAIN - OTHER CHEST PAIN

E942.0* CARDIAC RHYTHM REGULATORS CAUSING ADVERSE EFFECTS IN THERAPEUTIC USE

E942.1* CARDIOTONIC GLYCOSIDES AND DRUGS OF SIMILAR ACTION CAUSING ADVERSE EFFECTS IN THERAPEUTIC USE

* According to the ICD-9-CM book, diagnosis codes E942.0 and E942.1 are secondary diagnosis codes and should not be billed as the primary diagnosis.

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Medical record documentation maintained by the ordering/referring physician/nonphysician practitioner (e.g., complete history and physical, 12 lead EKG, and rhythm strip performed prior to initiation of the patient demand event recorder) must indicate the medical necessity for use of the patient demand single or multiple event recorder. If ICD-9 code 785.1 (Palpitations) is the diagnosis billed, the history and physical or other pertinent medical record documentation must support the presence of associated symptoms such as dizziness, shortness of breath, chest discomfort, or an underlying history of cardiac disease. The medical record should support that specific symptoms (syncope, dizziness, chest pain, palpitations, or shortness of breath) may correlate with intermittent cardiac arrhythmias and/or myocardial ischemia.

If the provider of the service is other than the ordering/referring physician/nonphysician practitioner, the order must state the indication/medical necessity for the patient demand event recorder, and the provider of the service is responsible for ensuring that all of the necessary coverage criteria have been met prior to the initiation of the patient demand event recorder.

The EKG rhythm strip transmission and interpretation must include the following information: the name of the patient, the presenting diagnosis, the time and date of the transmission, the lead of the EKG transmission, the PR interval, the QRS interval, the rate, the rhythm, the signature of the person interpreting the EKG strip, cardiovascular symptomatology reported by the patient at the time of the transmission, any necessary actions (e.g., notification of physician, emergency instructions given to patient, etc.) taken by the person interpreting the EKG rhythm strip.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they

may be subject to review for medical necessity.

Sources of Information and Basis for Decision

Holter Monitors, Cardiac Event Recorders and Insertable Loop Recorders (2005). Cardiovascular Consultants Medical Group. Retrieved September 27, 2005, from http://www.healthyhearts.com/monitor.htm.

Joshi, A.K., Kowey, P.R., Prystowsky, E.N., Benditt, D.G., Cannom, D.S., Pratt, C.M., et al. (2005). First Experience With a Mobile Cardiac Outpatient Telemetry (MCOT) System for the Diagnosis and Management of Cardiac Arrhythmia [Electronic version]. The American Journal of Cardiology 95(7), 878-881.

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was

developed in cooperation with advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 01/01/2011

Revision History Number 2

Revision History Explanation Revision Number:2 Start Date of Comment Period:N/A

Start Date of Notice Period:04/01/2012 Revised Effective Date:03/01/2012

LCR B2012-033

March 2012 Connection

Explanation of Revision: The LCD was revised to clarify language for coverage for the use of the event recorder under the “Indications and Limitations of Coverage and/or Medical Necessity” and “Documentation Requirements” sections of the LCD. In addition the “Sources of Information and Basis for Decision” section of the LCD was updated and under the “ICD-9 Codes that Support Medical Necessity” section of the LCD, the following ICD-9-CM codes/code ranges with descriptors were added: 427.81-427.89; 427.9; 786.09; and 786.50-786.59. The effective date of this revision is based on process date.

Revision Number 1

Start Date of Comment Period:N/A Start Date of Notice Period:01/01/2011 Revised Effective Date 01/01/2011

LCR B2011-016

December 2010 Update

Explanation of Revision: Annual 2011 HCPCS update. Descriptor revised for CPT codes 93268, 93270, 93271, and 93272 and deleted CPT codes 93012 and 93014. The effective date of this revision is based on date of service.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009

LCR B2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

For Florida (00590) this LCD (L29253) replaces LCD L6150 as the policy in notice. This document (L29253) is effective on 02/02/2009.

11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

93268 descriptor was changed in Group 1 93270 descriptor was changed in Group 1 93271 descriptor was changed in Group 1 93272 descriptor was changed in Group 1

11/21/2010 - The following CPT/HCPCS codes were deleted: 93012 was deleted from Group 1

93014 was deleted from Group 1

11/21/2011 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

93271 descriptor was changed in Group 1

Reason for Change Typographical Correction