Mobile Cardiac Outpatient Telemetry

Transcription

1 MEDICAL POLICY Mobile Cardiac Outpatient Telemetry BCBSA Ref. Policy: Effective Date: Aug. 1, 2017 Last Revised: July 11, 2017 Replaces: N/A RELATED MEDICAL POLICIES: N/A Select a hyperlink below to be directed to that section. POLICY CRITERIA CODING RELATED INFORMATION EVIDENCE REVIEW REFERENCES HISTORY Clicking this icon returns you to the hyperlinks menu above. Introduction Mobile cardiac outpatient telemetry is a small device that is connected to wires that are attached to the chest. It sends information to a distant doctor s office when an uneven heart rhythm is detected. It is considered an alternative to other heart monitors. There is not enough information from studies to be certain that this type of device works as well as other heart monitors in reducing heart problems and death. The use of this device is not yet proven. Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. Policy Coverage Criteria Procedure Outpatient cardiac telemetry (aka, mobile cardiac outpatient telemetry) Investigational Using outpatient cardiac telemetry (also known as mobile cardiac outpatient telemetry) as a diagnostic alternative to ambulatory event monitors is considered investigational.

2 Coding Code Description CPT 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 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 Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS). Related Information The available evidence suggests that long-term monitoring for atrial fibrillation after cryptogenic stroke or post cardiac ablation is associated with improved outcomes, but the specific type of monitoring associated with the best outcomes is not well-defined. Trials that have demonstrated improved outcomes have used either event monitors or implantable monitors. In addition, there are individual patient considerations that may make one type of monitor preferable over another. Table 1. Mobile Cardiac Outpatient Telemetry Device Class Description Sample Devices Mobile cardiac outpatient telemetry Continuously recording or CardioNetMCOT (BioTelemetry, autotriggered memory loop devices Malvern, PA) that transmit data to a central LifeStar Mobile Cardiac Page 2 of 7

3 Device Class Description Sample Devices recording station with real-time Telemetry (LifeWatch Services, monitoring and analysis Switzerland) SEEQ Mobile Cardiac Telemetry (Medtronic, Minneapolis, MN) Evidence Review Summary of Evidence For individuals with signs and/or symptoms suggestive of arrhythmia who receive outpatient cardiac telemetry, the evidence includes 1 RCT and nonrandomized studies evaluating rates of arrhythmia detection. Relevant outcomes are overall survival and morbid events. The available evidence has suggested that outpatient cardiac telemetry is at least as good at detecting arrhythmias as ambulatory event monitoring. However, studies have not evaluated whether the real-time monitoring feature of outpatient cardiac telemetry leads to reduced cardiac events and mortality. The evidence is insufficient to determine the effects of the technology on health outcomes. Therefore the use of these devices is considered investigational. Mobile Cardiac Outpatient Telemetry This policy addresses whether the addition of real-time monitoring (mobile cardiac outpatient telemetry, or MCOT) to ambulatory cardiac monitoring is associated with improved outcomes. Two factors must be addressed in evaluating MCOT: (1) the inherent detection capability of the monitoring devices and (2) whether the real-time transmission and interpretation of data confers an incremental health benefit. The proposed addition of real-time monitoring suggests that there may be a subset of individuals who require immediate intervention when an arrhythmia is detected. It is not clear which patients comprise that subset, or whether identification of those patients in the outpatient setting leads to improved outcomes such as reduced risk of sudden cardiac death. Additional studies must be done to assess the benefits of real-time transmission of data and not just arrhythmia detection rates. One RCT was identified that compared MCOT with standard event monitors. 2 This study enrolled patients at 17 centers and involved 305 patients randomly assigned to the LOOP recorder or MCOT and were monitored for up to 30 days. Those enrolled were patients for whom the investigators had a strong suspicion of an arrhythmic cause of symptoms which included Page 3 of 7

4 syncope, presyncope, or severe palpitations occurring less frequently than once per 24 hours. The enrollees also all had a nondiagnostic 24-hour Holter or telemetry monitor within the prior 45 days. Test results were read in a blinded fashion by an electrophysiologist. Most patients in the control group had a patient-triggered event monitor. Only a subset of patients (n=50) had autotrigger devices, thus precluding comparison of MCOT and autotrigger devices. A diagnostic end point (confirmation/exclusion of an arrhythmic cause of symptoms) was found in 88% of MCOT patients and in 75% of LOOP patients (p=0.008). The difference in rates was primarily due to detection of asymptomatic arrhythmias (not associated with simultaneous symptoms) in the MCOT group. These symptoms consisted of rapid AF and/or flutter (15 patients vs 1 patient) and ventricular tachycardia defined as more than 3 beats and rate greater than 100 (14 patients vs 2 patients). These differences were thought to be clinically significant rhythm disturbances and the likely causes of the patients symptoms. The authors did not comment on the clinical impact (changes in management) of these findings in patients for whom the rhythm disturbance was not linked to symptoms. In this study, median time to diagnosis in the total study population was 7 days in the MCOT group and 9 days in the LOOP group. Kadish et al evaluated the frequency with which events transmitted by MCOT represented emergent arrhythmias, thereby indirectly assessing the clinical utility of real-time outpatient monitoring. 3 A total of 26,438 patients who had undergone MCOT during a 9-month period were retrospectively examined. Of these patients, 21% (5,459) had an arrhythmic event requiring physician notification, and 1% (260) had an event that could be considered potentially emergent. These potentially emergent events included 120 patients with wide-complex tachycardia, 100 patients with sinus pauses 6 seconds or longer, and 42 with sustained bradycardia at less than 30 beats per minute. A number of uncontrolled case series have reported on arrhythmia detection rates of MCOT. 4-7 One such published study described the outcomes of a consecutive case series of 100 patients. 4 Patients with a variety of symptoms were included, most commonly palpitations (47%), dizziness (24%), or syncope (19%), as well as those being evaluated for efficacy of drug treatment (25%). Clinically significant arrhythmias were detected in 51% of patients, but half of these patients were asymptomatic. The authors commented that the automatic detection resulted in an increased diagnostic yield, but there was no discussion of its unique feature (ie, the real-time analysis, transmission, and notification of arrhythmia). Studies have evaluated the use of MCOT in detecting AF. In the largest study evaluating the diagnostic yield of MCOT for AF, Favilla et al reported results of a retrospective cohort of 227 patients with cryptogenic stroke or TIA who underwent 28 days of monitoring with mobile cardiac outpatient telemetry. 8 AF was detected in 14% (31/227) of patients, of whom 3 reported Page 4 of 7

5 symptoms at the time of AF. Oral anticoagulation was initiated in 26 (84%) patients diagnosed with AF. Of the remaining 5 (16%) who were not anticoagulated, 1 had a prior history of gastrointestinal bleeding, 3 were unwilling to accept the risk of bleeding, and 1 failed to followup. In an uncontrolled case series, Tayal et al retrospectively analyzed patients with cryptogenic stroke who had not been diagnosed with AF by standard monitoring. 7 In this study, 13 (23%) of 56 patients with cryptogenic stroke had AF with MCOT. Twenty-seven asymptomatic AF episodes were detected in the 13 patients, and 23 of these were less than 30 seconds in duration. In contrast, Kalani et al reported a diagnostic yield for AF of 4.7% (95% CI, 1.5% to 11.9%) in a series of 85 patients with cryptogenic stroke. 9 In this series, 82.4% of patients had completed transesophageal echocardiography, cardiac magnetic resonance imaging (cmri), or both, with negative results. The authors proposed that the use of advanced cardiac imaging may alter the underlying prevalence of AF in patients labeled as having cryptogenic stroke. In an earlier retrospective cohort study, Miller et al retrospectively analyzed paroxysmal AF detection rates among 156 patients evaluated with MCOT within 6 months of a cryptogenic stroke or TIA. 1 Over a median 21-day period of MCOT monitoring (range, 1-30 days), AF was detected in 17.3% of patients. Mean time to first occurrence of AF was 8.8 days (range, 1-21 days). Section Summary The available evidence suggests that MCOT is likely at least as good at detecting arrhythmias as ambulatory event monitoring. Compared with ambulatory event monitoring, MCOT is associated with the theoretical advantage of real-time monitoring, allowing for emergent intervention for potentially life-threatening arrhythmias. One study reported that 1% of arrhythmic events detected on MCOT over a 9-month period could be considered potentially emergent. However, no studies were identified that addressed whether the use of MCOT is associated with differences in the management of or outcomes after these potentially emergent events. The addition of real-time monitoring to outpatient ambulatory monitoring is considered an enhancement to existing technology. There is insufficient evidence to demonstrate a clinically significant incremental benefit of MCOT. Therefore this service is considered investigational. Page 5 of 7

6 Clinical Input Received From Physician Specialty Societies and Academic Medical Centers Clinical input was obtained from 4 academic medical centers (3 reviews) and 3 physician specialty societies to provide information on mobile cardiac outpatient telemetry (MCOT) and new devices. There was no consensus whether MCOT is medically necessary. Reviewers did not agree whether real-time monitoring provides incremental benefits or improved health outcomes over ambulatory monitoring that is not being reviewed in real time. Medicare National Coverage There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers. References 1. Miller DJ, Khan MA, Schultz LR, et al. Outpatient cardiac telemetry detects a high rate of atrial fibrillation in t. Clin Cardiol. Oct 2014;37(10): PMID Rothman SA, Laughlin JC, Seltzer J, et al. The diagnosis of cardiac arrhythmias: a prospective multi-center randomized study comparing mobile cardiac outpatient telemetry versus standard loop event monitoring. J Cardiovasc Electrophysiol. Mar 2007;18(3): PMID Kadish AH, Reiffel JA, Clauser J, et al. Frequency of serious arrhythmias detected with ambulatory cardiac telemetry. Am J Cardiol. May ;105(9): PMID Joshi AK, Kowey PR, Prystowsky EN, et al. First experience with a Mobile Cardiac Outpatient Telemetry (MCOT) system for the diagnosis and management of cardiac arrhythmia. Am J Cardiol. Apr ;95(7): PMID Olson JA, Fouts AM, Padanilam BJ, et al. Utility of mobile cardiac outpatient telemetry for the diagnosis of palpitations, presyncope, syncope, and the assessment of therapy efficacy. J Cardiovasc Electrophysiol. May 2007;18(5): PMID Saarel EV, Doratotaj S, Sterba R. Initial experience with novel mobile cardiac outpatient telemetry for children and adolescents with suspected arrhythmia. Congenital heart disease. Jan-Feb 2008;3(1): PMID Tayal AH, Tian M, Kelly KM, et al. Atrial fibrillation detected by mobile cardiac outpatient telemetry in cryptogenic TIA or stroke. Neurology. Nov ;71(21): PMID Favilla CG, Ingala E, Jara J, et al. Predictors of finding occult atrial fibrillation after cryptogenic stroke. Stroke. May 2015;46(5): PMID Kalani R, Bernstein R, Passman R, et al. Low yield of mobile cardiac outpatient telemetry after cryptogenic stroke in patients with extensive cardiac imaging. J Stroke Cerebrovasc Dis. Sep 2015;24(9): PMID Page 6 of 7

7 10. Calkins H, Kuck KH, Cappato R, et al HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design. J Interv Card Electrophysiol. Mar 2012;33(2): PMID Blue Cross Blue Shield Association. Ambulatory Event Monitors and Mobile Cardiac Outpatient Telemetry. Medical Policy Reference Manual. Policy , History Date Comments 08/09/16 New policy, add to Cardiology section. Use of MCOT is considered investigational. Policy will be effective 01/01/17. 10/25/16 Effective date revision. Policy will be effective 03/01/17. 02/24/17 Effective date revision. Policy will be effective 03/15/17. 03/15/17 Effective date revision. Policy will be effective 03/17/17. 03/17/17 Effective date revision. Policy will be effective 03/31/17. 03/23/17 Effective date revision. Policy will be effective 03/24/17. Coding update; removed CPT codes 0295T-0298T. Minor formatting update. 08/01/17 Annual review, approved July 11, No changes to policy statement. Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA) Premera All Rights Reserved. Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage. Page 7 of 7

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9 日本語 (Japanese): この通知には重要な情報が含まれています この通知には LifeWise Health Plan of Oregon の申請または補償範囲に関する重要な情報が含まれている場合があります この通知に記載されている可能性がある重要な日付をご確認ください 健康保険や有料サポートを維持するには 特定の期日までに行動を取らなければならない場合があります ご希望の言語による情報とサポートが無料で提供されます (TTY: ) までお電話ください 한국어 (Korean): 본통지서에는중요한정보가들어있습니다. 즉이통지서는귀하의신청에관하여그리고 LifeWise Health Plan of Oregon 를통한커버리지에관한정보를포함하고있을수있습니다. 본통지서에는핵심이되는날짜들이있을수있습니다. 귀하는귀하의건강커버리지를계속유지하거나비용을절감하기위해서일정한마감일까지조치를취해야할필요가있을수있습니다. 귀하는이러한정보와도움을귀하의언어로비용부담없이얻을수있는권리가있습니다 (TTY: ) 로전화하십시오. ລາວ (Lao): ແຈ ງການນ ມ ຂ ມ ນສ າຄ ນ. ແຈ ງການນ ອາດຈະມ ຂ ມ ນສ າຄ ນກ ຽວກ ບຄ າຮ ອງສະ ໝ ກ ຫ ຄວາມຄ ມຄອງປະກ ນໄພຂອງທ ານຜ ານ LifeWise Health Plan of Oregon. ອາດຈະມ ວ ນທ ສ າຄ ນໃນແຈ ງການນ. ທ ານອາດຈະຈ າເປ ນຕ ອງດ າເນ ນ ການຕາມກ ານ ດເວລາສະເພາະເພ ອຮ ກສາຄວາມຄ ມຄອງປະກ ນສ ຂະພາບ ຫ ຄວາ ມຊ ວຍເຫ ອເລ ອງຄ າໃຊ ຈ າຍຂອງທ ານໄວ. ທ ານມ ສ ດໄດ ຮ ບຂ ມ ນນ ແລະ ຄວາມ ຊ ວຍເຫ ອເປ ນພາສາຂອງທ ານໂດຍບ ເສຍຄ າ. ໃຫ ໂທຫາ ភ ស ខមរ (Khmer): សចកត ជ នដ ណ ង ន ម នព ត ម នយ ងស ខ ន សចកត ជ នដ ណ ង ន រប ហល ជ ម នព ត ម នយ ងស ខ ន អ ព ទរមង បបបទ ឬក ររ ប រងរបស អនកត មរយ LifeWise Health Plan of Oregon រប ហលជ ម ន ក លបរ ចឆទស ខ ន ន កន ង សចកត ជ នដ ណ ង ន អនករប ហលជ រត វក រប ញច ញសមតថភ ព ដល ក ណត ថង ជ ក ចប ស ន ន ដ មប ន ងរកស ទ កក រធ ន រ ប រងស ខភ ពរបស អនក ឬរប ក ជ ន យ ចញ ថល អនកម នស ទធ ទទ លព ត ម ន ន ន ងជ ន យ ន កន ងភ ស របស អនក ដ យម នអសល យ ឡ យ ស មទ រស ពទ (TTY: ) ਪ ਜ ਬ (Punjabi): ਇਸ ਨ ਟਸ ਵਚ ਖ ਸ ਜ ਣਕ ਰ ਹ. ਇਸ ਨ ਟਸ ਵਚ LifeWise Health Plan of Oregon ਵਲ ਤ ਹ ਡ ਕਵਰ ਜ ਅਤ ਅਰਜ ਬ ਰ ਮਹ ਤਵਪ ਰਨ ਜ ਣਕ ਰ ਹ ਸਕਦ ਹ. ਇਸ ਨ ਜਸ ਜਵਚ ਖ ਸ ਤ ਰ ਖ ਹ ਸਕਦ ਆ ਹਨ. ਜ ਕਰ ਤ ਸ ਜਸਹਤ ਕਵਰ ਜ ਰ ਖਣ ਹ ਵ ਜ ਓਸ ਦ ਲ ਗਤ ਜ ਵ ਚ ਮਦਦ ਦ ਇਛ ਕ ਹ ਤ ਤ ਹ ਨ ਅ ਤਮ ਤ ਰ ਖ਼ ਤ ਪ ਹਲ ਕ ਝ ਖ ਸ ਕਦਮ ਚ ਕਣ ਦ ਲ ੜ ਹ ਸਕਦ ਹ,ਤ ਹ ਨ ਮ ਫ਼ਤ ਵ ਚ ਤ ਆਪਣ ਭ ਸ਼ ਵ ਚ ਜ ਣਕ ਰ ਅਤ ਮਦਦ ਪ ਰ ਪਤ ਕਰਨ ਦ ਅ ਧਕ ਰ ਹ,ਕ ਲ (Farsi): فارسی اين اعالميه حاوی اطالعات مھم ميباشد.اين اعالميه ممکن است حاوی اطالعات مھم درباره فرم تقاضا و يا پوشش بيمه ای شما از طريق LifeWise Health Plan of Oregon باشد. به تاريخ ھای مھم در اين اعالميه توجه نماييد.شما ممکن است برای حقظ پوشش بيمه تان يا کمک در پرداخت ھزينه ھای درمانی تان به تاريخ ھای مشخصی برای انجام کارھای خاصی احتياج داشته باشيد.شما حق اين را داريد که اين اطالعات و کمک را به زبان خود به طور رايگان دريافت نماييد. برای کسب اطالعات با شماره (کاربران TTY تماس باشماره ) تماس برقرار نماييد. Polskie (Polish): To ogłoszenie może zawierać ważne informacje. To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez LifeWise Health Plan of Oregon. Prosimy zwrócic uwagę na kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami. Macie Państwo prawo do bezpłatnej informacji we własnym języku. Zadzwońcie pod Português (Portuguese): Este aviso contém informações importantes. Este aviso poderá conter informações importantes a respeito de sua aplicação ou cobertura por meio do LifeWise Health Plan of Oregon. Poderão existir datas importantes neste aviso. Talvez seja necessário que você tome providências dentro de determinados prazos para manter sua cobertura de saúde ou ajuda de custos. Você tem o direito de obter esta informação e ajuda em seu idioma e sem custos. Ligue para Română (Romanian): Prezenta notificare conține informații importante. Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin LifeWise Health Plan of Oregon. Pot exista date cheie în această notificare. Este posibil să fie nevoie să acționați până la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri. Aveți dreptul de a obține gratuit aceste informații și ajutor în limba dumneavoastră. Sunați la Pусский (Russian): Настоящее уведомление содержит важную информацию. Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через LifeWise Health Plan of Oregon. В настоящем уведомлении могут быть указаны ключевые даты. Вам, возможно, потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами. Вы имеете право на бесплатное получение этой информации и помощь на вашем языке. Звоните по телефону Fa asamoa (Samoan): Atonu ua iai i lenei fa asilasilaga ni fa amatalaga e sili ona taua e tatau ona e malamalama i ai. O lenei fa asilasilaga o se fesoasoani e fa amatala atili i ai i le tulaga o le polokalame, LifeWise Health Plan of Oregon, ua e tau fia maua atu i ai. Fa amolemole, ia e iloilo fa alelei i aso fa apitoa olo o iai i lenei fa asilasilaga taua. Masalo o le a iai ni feau e tatau ona e faia ao le i aulia le aso ua ta ua i lenei fa asilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olo o e iai i ai. Olo o iai iate oe le aia tatau e maua atu i lenei fa asilasilaga ma lenei fa matalaga i legagana e te malamalama i ai aunoa ma se togiga tupe. Vili atu i le telefoni Español (Spanish): Este Aviso contiene información importante. Es posible que este aviso contenga información importante acerca de su solicitud o cobertura a través de LifeWise Health Plan of Oregon. Es posible que haya fechas clave en este aviso. Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura médica o ayuda con los costos. Usted tiene derecho a recibir esta información y ayuda en su idioma sin costo alguno. Llame al Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng LifeWise Health Plan of Oregon. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa ไทย (Thai): ประกาศน ม ข อม ลส าค ญ ประกาศน อาจม ข อม ลท ส าค ญเก ยวก บการการสม ครหร อขอบเขตประก น ส ขภาพของค ณผ าน LifeWise Health Plan of Oregon และอาจม ก าหนดการในประกาศน ค ณ อาจจะต องด าเน นการภายในก าหนดระยะเวลาท แน นอนเพ อจะร กษาการประก นส ขภาพของค ณหร อการ ช วยเหล อท ม ค าใช จ าย ค ณม ส ทธ ท จะได ร บข อม ลและความช วยเหล อน ในภาษาของค ณโดยไม ม ค าใช จ าย โทร (TTY: ) Український (Ukrainian): Це повідомлення містить важливу інформацію. Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через LifeWise Health Plan of Oregon. Зверніть увагу на ключові дати, які можуть бути вказані у цьому повідомленні. Існує імовірність того, що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того, щоб зберегти Ваше медичне страхування або отримати фінансову допомогу. У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові. 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