Mobile Cardiac Outpatient Telemetry (Real-Time, Outpatient Cardiac Monitoring )

Transcription

1 Original Issue Date (Created): July 1, 2002 Most Recent Review Date (Revised): May 14, 2013 Effective Date: September 1, 2013 I. POLICY Ambulatory Event Monitors External The use of patient-activated or auto-activated external ambulatory event monitors may be considered medically necessary in the following situations: As a diagnostic alternative to Holter monitoring in patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of cardiac arrhythmias (i.e., palpitations, dizziness, presyncope, or syncope). Patients with atrial fibrillation who have been treated with catheter ablation, and in whom discontinuation of systemic anticoagulation is being considered. Implantable The use of implantable ambulatory event monitors, either patient-activated or autoactivated, may be considered medically necessary only in the small subset of patients who experience recurrent symptoms so infrequently that a prior trial of Holter monitor and other external ambulatory event monitors has been unsuccessful. Other uses of ambulatory event monitors are considered investigational, including but not limited to monitoring effectiveness of antiarrhythmic therapy and detection of myocardial ischemia by detecting ST segment changes, as there is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure for these indications. Mobile Cardiac Outpatient Telemetry (Real-Time, Outpatient Cardiac Monitoring ) Mobile cardiac outpatient telemetry (Real-time, outpatient cardiac monitoring) may be considered medically necessary only if ALL of the following conditions are met: The patient has demonstrated a need for cardiac monitoring. The patient has ANY of the following conditions: o Patients who require monitoring for known, non life-threatening arrhythmias, such as paroxysmal atrial fibrillation, other paroxysmal supra-ventricular Page 1

2 arrhythmias, evaluation of various bradyarrhythmias and intermittent bundle branch block; o Patients recovering from cardiac surgery who have had documented atrial arrhythmias; o Patients with symptomatic underlying structural disease; o Patients with no structural heart disease but who have recurrent severe symptoms (i.e., recurrent syncope), in whom all testing is negative and an implantable event recorder is contemplated; o Patients with uncontrolled atrial fibrillation post-pneumonectomy; The monitoring is performed by a lab that provides twenty-four (24) hour attendance. If 24-hour attended monitoring utilizing a memory loop monitor is utilized, the receiving station must be staffed on a twenty-four (24) hour basis, and should be able to direct the patient for the management of all emergencies. An answering service/answering machine would not fulfill this requirement. The person receiving the transmission must be a technician, nurse, or physician trained in interpreting EKGs and abnormal rhythms. A physician must be available twenty-four (24) hours a day for immediate consultation to review the transmission in case of significant symptoms or EKG abnormalities. The cardiac event recorder is utilized for one month in a twelve-month period. Medical necessity review is indicated for the use of the cardiac event recorder for more than one month in a twelve-month period and requires supporting documentation (office notes). The use of the cardiac event monitor beyond a onemonth period should be allowed in the following situations: o After treatment has been initiated and the symptoms continue to occur; o No symptoms occurred during the initial thirty-day use of the monitor. Page 2

3 Mobile cardiac outpatient telemetry (Real-time, outpatient cardiac monitoring) is not medically necessary for the following: Patients with mild to moderate symptoms (i.e., palpitations or weakness); Patients at high risk of developing sustained ventricular tachycardia or ventricular fibrillation (e.g. EF<30% with widened QRS, severe valvular disease, unremitting angina, candidates for heart valve surgery) and/or would be more appropriately cared for in a hospital setting. Real-time, outpatient cardiac monitoring is contraindicated in these patients; Patients failing to fulfill the indications for coverage of this policy; Use as a screening tool. Cross-references MP Biventricular Pacemakers (Cardiac Resynchronization Therapy for the Treatment of Heart Failure II. PRODUCT VARIATIONS [N] = No product variation, policy applies as stated [Y] = Standard product coverage varies from application of this policy, see below [N] Capital Cares 4 Kids [N] PPO [N] HMO [Y] SeniorBlue HMO* [Y] SeniorBlue PPO* [N] SpecialCare [N] POS [Y] FEP PPO** [N] Indemnity *: Refer to Novitas Solutions Local Coverage Determination (LCD) L27520 Real Time Outpatient Telemetry. Also refer to the Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) 20.15, Electrocardiographic Services for additional medically necessary indications. ** Refer to FEP Medical Policy Manual MP Ambulatory Event Monitors and Mobile Cardiac Outpatient Telemetry. The FEP Medical Policy manual can be found at: Page 3

4 III. DESCRIPTION/BACKGROUND There are a wide variety of devices available for outpatient cardiac rhythm monitoring. The primary purpose of these devices is the evaluation of suspected arrhythmias that have not been detected by office- or hospital-based monitoring. These devices differ in the types of monitoring leads used, the duration and continuity of monitoring, the ability to detect arrhythmias without patient intervention, and the mechanism of delivery of the information from patient to clinician. A brief description of the major categories of devices is given below. There has been a trend in recent years toward using novel technology to increase the efficiency, comfort, and convenience of these devices. These technologic advances include the development of devices that are smaller and more convenient to use, as well as novel ways to rapidly transmit information, such as by use of mobile devices. These advances in technology may present challenges in categorizing new devices. Some of the newer devices are describe below for informational purposes in assigning them to the most relevant category. However, since there may be many devices within each category, a comprehensive description of individual devices is beyond the scope of this review. Continuous monitoring devices (Holter monitors and similar devices) Ambulatory Holter electrocardiography (EKG) is a widely used noninvasive test in which EKG is continuously recorded over an extended period of time, typically 24 to 48 hours, to evaluate symptoms suggestive of cardiac arrhythmias, i.e., palpitations, dizziness, or syncope. However, Holter monitoring will be ineffective if a patient experiences infrequent symptoms. Therefore, the sensitivity of Holter monitoring is low for detection of arrhythmias that are intermittent. Continuous monitoring devices with longer recording periods Some newer devices are continuous monitors that are similar to traditional Holter monitoring in concept, but offer other advantages such as the ability to monitor for longer periods of time. The Zio Patch system (irhythm Technologies, Inc., San Francisco, CA) is a longterm continuous monitoring system that is most analogous to a Holter monitor that records and stores information for longer time periods. It is primarily used for asymptomatic monitoring. This system consists of a patch worn over the left pectoral region of the body that records continuously for up to 14 days, while the patient keeps a symptom log. At the end of the recording period, the patient mails back the recorder in a pre-paid envelope to a central station and a full report is provided to the physician within a few days. Non-continuous monitoring devices (ambulatory event monitors and similar devices) Ambulatory event monitors (AEMs) were developed to provide longer periods of monitoring by using non-continuous monitoring. In this technique, the recording device is Page 4

5 either worn continuously and activated only when the patient experiences symptoms or is carried by the patient and applied and activated when symptoms are present. The recorded EKGs are then stored for future analysis or transmitted by telephone to a receiving station, e.g., a doctor's office; hospital; or cardiac-monitoring service, where the EKGs can then be analyzed. AEMs can be used for extended periods of time, typically up to 1 month or until the patient experiences symptoms. Since the EKGs are recorded only during symptoms, there is good correlation with any underlying arrhythmia. Conversely, if no EKG abnormality is noted, a noncardiac etiology of the patient's symptoms can be sought. Several different types of AEMs are available: Noncontinuous devices with memory These devices are carried by the patient and applied to the precordial area via nongel electrodes when the symptoms are occurring or, alternatively, a recording device may be worn on the wrist and then activated when symptoms are present. The limitation of these devices is that an arrhythmia of very short duration would be difficult to record. In addition, noncontinuous devices require reasonable dexterity on the part of the patient to apply the device correctly during a symptomatic period. This is a particular limitation if the patient is incapacitated during symptomatic periods. The Zio Event Card (irhythm Technologies, Inc., San Francisco, CA) is a noncontinuous real-time recording device that can be worn up to 30 days. This device can be worn comfortably under clothing (including during sleep), as it weighs less than 2 ounces and is similar in size to a standard credit card. Upon activation by the patient, the card is able to record the previous 45 seconds of electrocardiography (ECG) activity into memory plus the first 15 seconds after the button is pushed. This is made possible because this device continuously scans for ECG activity but only records upon symptom activation. After the device is activated, the patient is responsible for calling the irhythm National Clinical Center (NCCC), which then instructs the patient on sending the event over the phone line. The REKA E100 system is a noncontinuous single-lead cardiac event monitor. This device is the size of a hockey puck and weighs no more than a few ounces. There are 2 options, depending on the patient s circulation: 1) a zero-lead device that is separate from the body and may be carried in a purse or coat pocket; or if a patient s circulation is determined to be inadequate, 2) a single electrode lead that the patient connects to the device at the time of an event. The zero-lead device records an event by patient activation and can record and store up to 2,000 readings. The patient has the option of sending stored event information to the physician across a free-of-charge phone app or the Internet in their computer. Internet transmission requires one of the following systems: Android, Blackberry, iphone 3, 3S, 4, and 4S, ipad, ipod Touch Microsoft, or Windows. Continuous "memory loop" devices Page 5

6 These devices are able to continuously store a single channel of EKG data in a refreshed memory. If the patient activates the device, the EKG is then recorded from the memory loop for the preceding 30 to 90 seconds and for the next minute or so. Therefore, these types of devices permit recording of the onset of arrhythmias and/or transient or incapacitating events. They obviously must be worn continuously. Implantable continuous memory loop devices An implantable loop recorder device is inserted just under the patient s skin in the chest area during an outpatient surgical procedure. When symptoms are felt, the patient places a hand-held activator over the recorder to activate the storage of cardiac rhythms. This device can be used for more than 1 year. The Reveal Insertable Loop Recorder (Medtronic) is an implantable memory loop device recently approved by the U.S. Food and Drug Administration (FDA). Autotrigger devices All of the previously described devices require activation by the patient. More recently, autotriggering technology has become available, which can be adapted to memory loop devices. For example, event monitors can be programmed to detect heart rates greater than 165 beats per minute, less than 40 beats per minute, or an asystole of greater than 3 seconds. Implantable continuous memory loop devices with autotrigger These devices combine the long-term monitoring available with implantable devices with the autotriggers seen on newer event monitors. These devices contain algorithms that are programmed to detect heart rates exceeding an upper or lower limit, asystole of greater than 3 seconds. They typically contain other autotriggers, such as a variable RR interval seen with atrial fibrillation. Mobile Cardiac Outpatient Telemetry Ambulatory event monitors store the recorded data, which are ultimately transmitted either to a physician s office or to a central recording station. In contrast, outpatient cardiac telemetry provides real-time monitoring and analysis. For example, CardioNet Inc. (Conshohocken, PA) offers mobile cardiac outpatient telemetry. In this system, the patient wears a 3-lead sensor, which constantly communicates with the CardioNet monitor, a lightweight unit that can be carried in a pocket or a purse. When an arrhythmia is detected according to preset parameters, the EKG is automatically transmitted to a central CardioNet service center, where the EKG is immediately interpreted, with results sent to the referring physician. The referring physician can request the level and timing of response, ranging from daily reports to stat results. Other systems for outpatient cardiac telemetry include the HEARTLink II system (Cardiac Telecom Corp.), the Vital Signs Transmitter (VST, Biowatch Medical, Columbia, SC), and the Lifestar Ambulatory Cardiac Telemetry (ACT) system (Card Guard Scientific Survival Ltd., Israel). The CardioNet system has a built-in cellular telephone that automatically transmits signals when the patient is away from home. Page 6

7 The VectraplexECG System is a real-time continuous Mobile Cardiac Outpatient Telemetry device to measure ischemic ECG changes that can be indicative of a myocardial infarction (MI). This device utilizes the Internet to communicate real-time ECG changes to the physician. The patient is hooked up to a mini-tablet by either 5 electrodes, which communicate 15-lead ECG data, or 10 electrodes that communicate 12-lead ECG data. While this system is primarily intended to monitor for ischemia, the continuous ECG monitoring would presumably detect rhythm disturbances, as well as ischemic changes IV. DEFINITIONS HOLTER MONITOR is a portable device small enough to be worn by a patient during normal activity. It consists of an electrocardiograph and a recording system capable of storing up to twenty-four hours of the patient's EKG record. MYOCARDIAL INFARCTION is the loss of heart muscle as a result of coronary artery occlusion. SYNCOPE is a sudden but transient total loss of consciousness with spontaneous resolution. V. BENEFIT VARIATIONS The existence of this medical policy does not mean that this service is a covered benefit under the member's contract. Benefit determinations should be based in all cases on the applicable contract language. Medical policies do not constitute a description of benefits. A member s individual or group customer benefits govern which services are covered, which are excluded, and which are subject to benefit limits and which require preauthorization. Members and providers should consult the member s benefit information or contact Capital for benefit information. VI. DISCLAIMER Capital s medical policies are developed to assist in administering a member s benefits, do not constitute medical advice and are subject to change. Treating providers are solely responsible for medical advice and treatment of members. Members should discuss any medical policy related to their coverage or condition with their provider and consult their benefit information to determine if the service is covered. If there is a discrepancy between this medical policy and a member s benefit information, the benefit information will govern. Capital considers the information contained in this medical policy to be proprietary and it may only be disseminated as permitted by law. Page 7

8 VII. REFERENCES Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) Electrocardiographic (EKG) Services. Effective 8/26/2004. CMS [Website]: 0%2E15%3A2%3AElectrocardiographic+%28EKG%29+Services. Accessed November 7, Hanke T, Charitos EI, Stierle U et al. Twenty-four-hour holter monitor follow-up does not provide accurate heart rhythm status after surgical atrial fibrillation ablation therapy: up to 12 months experience with a novel permanently implantable heart rhythm monitor device. Circulation 2009; 120:S177-S184. Hindricks G, Pokushalov E, Urban L et al. Performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation: Results of the XPECT trial. Circ Arrhythm Electrophysiol 2010; 3: Hoefman E, Bindels PJ, van Weert HC. Efficacy of diagnostic tools for detecting cardiac arrhythmias: systematic literature search. Neth Heart J 2010; 18(11): Kadish AH, Reiffel JA, Clauser J et al. Frequency of serious arrhythmias detected with ambulatory cardiac telemetry. Am J Cardiol 2010; 105(9): Leshem-Rubinow E, Berger M, Shacham J et al. New real-time loop recorder diagnosis of symptomatic arrhythmia via telemedicine. Clin Cardiol 2011; 34(7):420-5 Novitas Solutions. Local Coverage Determination (LCD) (LCD) L27520: Real-Time, Outpatient Cardiac Monitoring. Effective 01/01/2013. [Website]: Accessed May 6, 2013 Podrid P. Ambulatory monitoring in the assessment of cardiac arrhythmias. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated February 22, [Website] : Accessed November 7, Rothman SA, Laughlin JC, Seltzer J et al. The diagnosis of cardiac arrhythmias: a prospective multi-center randomized study comparing mobile outpatient telemetry versus standard loop event monitoring. J Cardiovasc Electrophysiol 2007; 18: Saarel EV, Doratotaj S, Sterba R. Initial experience with novel mobile cardiac outpatient telemetry for children and adolescents with suspected arrhythmia. Congenit Heart Dis 2008; 3(1):33-8. Sankari Z, Adeli H. HeartSaver: a mobile cardiac monitoring system for auto-detection of atrial fibrillation, myocardial infarction, and atrio-ventricular block. Comput Biol Med 2011; 41(4): Taber's Cyclopedic Medical Dictionary, 20th edition. Tayal AH, Tian M, Kelly KM et al. Atrial fibrillation detected by mobile cardiac outpatient telemetry in cryptogenic TIA or stroke. Neurology 2008; 71(21): Page 8

9 VIII. CODING INFORMATION Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement. Covered when medically necessary: CPT Codes Current Procedural Terminology (CPT) copyrighted by American Medical Association. All Rights Reserved. HCPCS Code E0616 C1764 Description IMPLANTABLE CARDIAC EVENT RECORDER WITH MEMORY, ACTIVATOR AND PROGRAMMER EVENT RECORDER, CARDIAC (IMPLANTABLE) Investigational; therefore not covered CPT Codes 0293T 0294T 0295T 0296T 0297T 0298T Current Procedural Terminology (CPT) copyrighted by American Medical Association. All Rights Reserved. ICD-9-CM Diagnosis Description Code* ACUTE MYOCARDIAL INFARCTION OF ANTEROLATERAL WALL, EPISODE OF ACUTE MYOCARDIAL INFARCTION OF ANTEROLATERAL WALL, INITIAL EPISODE OF ACUTE MYOCARDIAL INFARCTION OF ANTEROLATERAL WALL, SUBSEQUENT EPISODE OF ACUTE MYOCARDIAL INFARCTION OF OTHER ANTERIOR WALL, EPISODE OF ACUTE MYOCARDIAL INFARCTION OF OTHER ANTERIOR WALL, INITIAL EPISODE OF ACUTE MYOCARDIAL INFARCTION OF OTHER ANTERIOR WALL, SUBSEQUENT EPISODE OF ACUTE MYOCARDIAL INFARCTION OF INFEROLATERAL WALL, EPISODE OF Page 9

10 ICD-9-CM Diagnosis Description Code* ACUTE MYOCARDIAL INFARCTION OF INFEROLATERAL WALL, INITIAL EPISODE OF ACUTE MYOCARDIAL INFARCTION OF INFEROLATERAL WALL, SUBSEQUENT EPISODE OF ACUTE MYOCARDIAL INFARCTION OF INFEROPOSTERIOR WALL, EPISODE OF ACUTE MYOCARDIAL INFARCTION OF INFEROPOSTERIOR WALL, INITIAL EPISODE OF ACUTE MYOCARDIAL INFARCTION OF INFEROPOSTERIOR WALL, SUBSEQUENT EPISODE OF ACUTE MYOCARDIAL INFARCTION OF OTHER INFERIOR WALL, EPISODE OF ACUTE MYOCARDIAL INFARCTION OF OTHER INFERIOR WALL, INITIAL EPISODE OF ACUTE MYOCARDIAL INFARCTION OF OTHER INFERIOR WALL, SUBSEQUENT EPISODE OF ACUTE MYOCARDIAL INFARCTION OF OTHER LATERAL WALL, EPISODE OF ACUTE MYOCARDIAL INFARCTION OF OTHER LATERAL WALL, INITIAL EPISODE OF ACUTE MYOCARDIAL INFARCTION OF OTHER LATERAL WALL, SUBSEQUENT EPISODE OF ACUTE MYOCARDIAL INFARCTION, TRUE POSTERIOR WALL INFARCTION, EPISODE OF ACUTE MYOCARDIAL INFARCTION, TRUE POSTERIOR WALL INFARCTION, INITIAL EPISODE OF ACUTE MYOCARDIAL INFARCTION, TRUE POSTERIOR WALL INFARCTION, SUBSEQUENT EPISODE OF ACUTE MYOCARDIAL INFARCTION, SUBENDOCARDIAL INFARCTION, EPISODE OF ACUTE MYOCARDIAL INFARCTION, SUBENDOCARDIAL INFARCTION, INITIAL EPISODE OF ACUTE MYOCARDIAL INFARCTION, SUBENDOCARDIAL INFARCTION, SUBSEQUENT EPISODE OF ACUTE MYOCARDIAL INFARCTION OF OTHER SPECIFIED SITES, EPISODE OF ACUTE MYOCARDIAL INFARCTION OF OTHER SPECIFIED SITES, INITIAL EPISODE OF ACUTE MYOCARDIAL INFARCTION OF OTHER SPECIFIED SITES, SUBSEQUENT EPISODE OF Page 10

11 ICD-9-CM Diagnosis Description Code* ACUTE MYOCARDIAL INFARCTION, SITE, EPISODE OF ACUTE MYOCARDIAL INFARCTION, SITE, INITIAL EPISODE OF ACUTE MYOCARDIAL INFARCTION, SITE, SUBSEQUENT EPISODE OF ATRIOVENTRICULAR BLOCK, COMPLETE ATRIOVENTRICULAR BLOCK FIRST DEGREE ATRIOVENTRICULAR BLOCK MOBITZ (TYPE) II ATRIOVENTRICULAR BLOCK OTHER SECOND DEGREE ATRIOVENTRICULAR BLOCK LEFT BUNDLE BRANCH HEMIBLOCK OTHER LEFT BUNDLE BRANCH BLOCK RIGHT BUNDLE BRANCH BLOCK BUNDLE BRANCH BLOCK RIGHT BUNDLE BRANCH BLOCK AND LEFT POSTERIOR FASCICULAR BLOCK RIGHT BUNDLE BRANCH BLOCK AND LEFT ANTERIOR FASCICULAR BLOCK OTHER BILATERAL BUNDLE BRANCH BLOCK TRIFASCICULAR BLOCK OTHER HEART BLOCK ANOMALOUS ATRIOVENTRICULAR EXCITATION LOWN-GANONG-LEVINE SYNDROME LONG QT SYNDROME OTHER SPECIFIED CONDUCTION DISORDER CONDUCTION DISORDER PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PAROXYSMAL VENTRICULAR TACHYCARDIA PAROXYSMAL TACHYCARDIA ATRIAL FIBRILLATION ATRIAL FLUTTER VENTRICULAR FIBRILLATION VENTRICULAR FLUTTER CARDIAC ARREST PREMATURE BEATS SUPRAVENTRICULAR PREMATURE BEATS OTHER PREMATURE BEATS SINOATRIAL NODE DYSFUNCTION OTHER SPECIFIED CARDIAC DYSRHYTHMIAS CARDIAC DYSRHYTHMIA Page 11

12 ICD-9-CM Diagnosis Description Code* CONGESTIVE HEART FAILURE, TRANSIENT CEREBRAL ISCHEMIA CONGENITAL HEART BLOCK SYNCOPE AND COLLAPSE DIZZINESS AND GIDDINESS TACHYCARDIA PALPITATIONS ORTHOPNEA SHORTNESS OF BREATH CHEST PAIN V12.53 SUDDEN CARDIAC ARREST *If applicable, please see Medicare LCD or NCD for additional covered diagnoses. Page 12

13 The following ICD-10 diagnosis codes will be effective October 1, 2014 ICD-10-CM Diagnosis Description Code* I44.0- I44.7 Atrioventricular and left bundle-branch block code range I45.0 I45.9 Other conduction disorders code range I47.0 I47.9 Paroxysmal tachycardia code range I48.0 I48.1 Atrial fibrillation and flutter code range R00.2 Palpitations R42 R55 Dizziness and giddiness Syncope and collapse IX. POLICY HISTORY MP CAC 2/25/03 CAC 7/29/03 CAC 11/30/04 CAC 10/25/05 CAC 2/28/06 CAC 2/27/07 CAC 4/24/07 CAC 5/27/08 J12 MAC 12/12/08 CAC 3/31/09 Consensus CAC 3/30/10 Consensus CAC 7/26/11 Adopted BCBSA: Ambulatory event monitoring (AEM) criteria for monitoring of antiarrhythmic therapy revised from Medically Necessary to Investigational. Medicare variation added for AEM. 1/31/2012 Admin Change as per instructions regarding Holter Monitor. CAC 3/26/13 Minor review This is a partial adopt BCBSA policy. Section on Mobile Cardiac Outpatient Telemetry (Outpatient Cardiac Telemetry) does not match BCBSA. Regarding use of patient-activated or auto-activated external ambulatory event monitors. The following was added as medically necessary. Patients with atrial fibrillation who have been treated with catheter ablation, and in whom discontinuation of systemic anticoagulation is being considered Page 13

14 References updated. FEP variation added to reference the FEP manual. Background/Description updated to be current with advancing technology. Added reference to Novitas Solutions Local Coverage Determination (LCD) L27520 Real Time Outpatient Telemetry in Medicare variation. 02/18/2013- Unspecified codes removed from policy-skb 05/13/13-Administrative code review completed. Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage Insurance Company, Capital Advantage Assurance Company and Keystone Health Plan Central. Independent licensees of the BlueCross BlueShield Association. Communications issued by Capital BlueCross in its capacity as administrator of programs and provider relations for all companies. Page 14