Responsive Neurostimulation for the Treatment of Refractory Partial Epilepsy

Transcription

1 MEDICAL POLICY Responsive Neurostimulation for the Treatment of Refractory Partial Epilepsy BCBSA Ref. Policy: Effective Date: July 1, 2017 Last Revised: June 22, 2017 Replaces: N/A RELATED MEDICAL POLICIES: Vagus Nerve Stimulation Deep Brain Stimulation 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 Responsive neurostimulation (RNS) is a treatment that is used for partial onset epilepsy. The goal is to disrupt unusual electrical signals in the brain that trigger seizures. A stimulator is implanted, and one or two wires are placed at the location in the brain where seizures start. When the unit detects patterns that could lead to a seizure, it sends electrical signals to interrupt a seizure before it begins. RNS may be an option when medications aren t able to control symptoms. This policy describes when RNS may be considered medically necessary. 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 Responsive Medical Necessity Responsive neurostimulation (RNS) may be considered

2 Procedure neurostimulation (RNS) Medical Necessity medically necessary for patients with partial epilepsy who meet ALL of the following criteria: Are 18 years or older Have a diagnosis of partial-onset seizures with 1 or 2 welllocalized seizure foci identified Have had an average of 3 or more disabling seizures (eg, motor partial seizures, complex partial seizures, or secondarygeneralized seizures) per month over the prior 3 months Are refractory to medical therapy (have failed 2 or more appropriate antiepileptic medications at therapeutic doses) Are not candidates for focal resective epilepsy surgery (eg, have an epileptic focus near eloquent cerebral cortex; have bilateral temporal epilepsy) Do not have contraindications for RNS placement: o Three or more specific seizure foci OR o Presence of primary generalized epilepsy OR o Presence of a rapidly progressive neurologic disorder. Responsive neurostimulation (RNS) is considered investigational for all other indications not listed above. Coding Code Description CPT Twist drill or burr hole(s) for implantation of neurostimulator electrodes, cortical Craniectomy or craniotomy for implantation of neurostimulator electrodes, cerebral, cortical Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site (e.g., thalamus, globus pallidus, subthalamic nucleus, periventricular, periaqueductal gray), without use of Page 2 of 11

3 Code Description intraoperative microelectrode recording; first array Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site (eg, thalamus, globus pallidus, subthalamic nucleus, periventricular, periaqueductal gray), without use of intraoperative microelectrode recording; each additional array (List separately in addition to primary procedure) Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single electrode array Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to 2 or more electrode arrays Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple or complex brain, spinal cord, or peripheral (i.e., cranial nerve, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, without reprogramming Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple spinal cord, or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming HCPCS L8680 L8686 L8688 Note: Implantable neurostimulator electrode, each Implantable neurostimulator pulse generator, single array, non-rechargeable, includes extension Implantable neurostimulator pulse generator, dual array, non-rechargeable, includes extension 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 NeuroPace RNS System device was approved by the FDA as an adjunctive therapy for the treatment of adults with partial seizures when: Page 3 of 11

4 Disabling seizures occur frequently The seizures do not respond to seizure medication Less than three locations in the brain are causing the seizure activity The seizures arise from important areas of the brain that cannot be surgically removed Evidence Review Description Responsive neurostimulation (RNS) for the treatment of epilepsy involves the use of 1 or more implantable electric leads that have both a seizure detection and neurostimulation function. The device is programmed using a proprietary algorithm to recognize seizure patterns from electrocorticography output and to deliver electrical stimulation with the goal of terminating a seizure. One device, the NeuroPace RNS System, has U.S. Food and Drug Administration (FDA) approval for the treatment of refractory partial (focal) epilepsy. Background Seizures and Seizure Disorders Focal-onset seizures (previously referred to as partial seizures) arise from a discrete area of the brain and can cause a range of symptoms, depending on the seizure type and the brain area involved. (A note on terminology: focal-onset seizures may be referred to in some studies as partial seizures. A 2017 position paper from the International League Against Epilepsy outlined updated terminology for seizure and epilepsy subtypes. 1 For example, focal-onset seizures are subdivided based on the associated level of consciousness, and subsequently into whether they are motor or non-motor-onset. Because most of the literature related to responsive neurostimulation uses the older classifications, we use the older terminology through much of the review.) Focal-onset seizures were further grouped into simple partial seizures, which may be associated with motor, sensory, or autonomic symptoms, or complex partial seizures, in which consciousness is affected. Complex partial seizures may be associated with abnormal Page 4 of 11

5 movements (automatisms). In some cases, partial seizures may result in secondary generalization, in which widespread brain electrical activity occurs after the onset of a partial seizure, thereby resulting in a generalized seizure. Seizure disorders may be grouped into epileptic syndromes based on a number of factors, including the types of seizures that occur and their localization, the age of onset, patterns on electroencephalogram (EEG), associated clinical or neuroimaging findings, and genetic factors. Temporal lobe epilepsy is the most common syndrome associated with partial-onset seizures. Of those with partial seizures, 30% to 40% have intractable epilepsy, defined as a failure to control seizures after 2 seizure medications have been appropriately chosen and used. 2 Epilepsy Treatment Medical Therapy for Seizures Standard therapy for seizures, including partial seizures, includes treatment with 1 or more antiepileptic drugs (AEDs), which include newer AEDs, like oxcarbazepine, lamotrigine, topiramate, gabapentin, pregabalin, levetiracetam, tiagabine, and zonisamide. 3 Currently, response to AEDs is less than ideal. One systematic review comparing newer AEDs for refractory partial epilepsy reported an overall average responder rate of 34.8% in treatment groups. 3 As a result, a substantial number of patients do not achieve good seizure control with medications alone. Surgical Therapy for Seizures When a discrete seizure focus can be identified, seizure control may be achieved through resection of the seizure focus (epilepsy surgery). For temporal lobe epilepsy, 1 randomized controlled trial (RCT) demonstrated that surgery for epilepsy was superior to prolonged medical therapy in reducing seizures associated with impaired awareness and in improving quality of life. 4 Surgery for refractory focal epilepsy (excluding simple partial seizures) is associated with 5- year freedom from seizure rates of 52%, with 28% of seizure-free individuals able to discontinue AEDs. 5 Selection of appropriate patients for epilepsy surgery is important, because those with nonlesional extratemporal lobe epilepsy have worse outcomes after surgery than those with nonlesional temporal lobe epilepsy. 6 Some patients are not candidates for epilepsy surgery if the seizure focus is located in an eloquent area of the brain or other region that cannot be removed without risk of significant neurologic deficit. Page 5 of 11

6 Neurostimulation for Neurologic Disorders Electrical stimulation at one of several locations has been used as therapy for epilepsy, either in addition to, or as an alternative to, medical or surgical therapy. Vagus nerve stimulation (VNS) has been widely used for refractory epilepsy, following FDA approval of a VNS device in 1997 and 2 RCTs evaluating VNS in epilepsy. 7 Although the mechanism of the VNS s therapeutic effects are not fully understood, VNS is thought to reduce seizure activity through activation of vagal visceral afferents with diffuse central nervous system projections, leading to a widespread effect on neuronal excitability. Stimulation of other locations in the neuroaxis has been studied for a variety of neurologic disorders. Electrical stimulation at deep brain nuclei (deep brain stimulation [DBS]) involves the use of chronic, continuous stimulation of a target. It has been most widely used in the treatment of Parkinson disease and other movement disorders, but it has also been investigated for epilepsy. DBS of the anterior thalamic nuclei has been studied in 1 RCT (the Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy [SANTE] trial), but DBS is not currently approved by the FDA for stimulation of the anterior thalamic nucleus. 8 Stimulation of the cerebellar and hippocampal regions and the subthalamic, caudate, and centromedian nuclei have also been evaluated for the treatment of epilepsy. 7 Responsive Neurostimulation (RNS) for Epilepsy RNS shares some features with DBS, but is differentiated by its use of direct cortical stimulation and by the fact that the device performs both monitoring and stimulation functions. The RNS system provides stimulation in response to detection of specific epileptiform patterns, while DBS provides continuous or intermittent stimulation at preprogrammed settings. Development of the RNS system arose out of observations related to the effects of cortical electrical stimulation for seizure localization. It has been observed that electrical cortical stimulation can terminate induced and spontaneous electrographic seizure activity in humans and animals. 9 Patients with epilepsy may undergo implantation of subdural monitoring electrodes for the purposes of seizure localization, which at times have been used for neurostimulation to identify eloquent brain regions. Epileptiform discharges that occur during stimulation for localization can be stopped by a train of neighboring brief electrical stimulations. 10 Page 6 of 11

7 In tandem with the recognition that cortical stimulation may be able to stop epileptiform discharges was the development of fast pre-ictal seizure prediction algorithms. These algorithms involve the interpretation of electrocorticographic data from detection leads over the cortex. The RNS process thus includes electrocorticographic monitoring via cortical electrodes, analysis of data through a proprietary seizure detection algorithm, and delivery of electrical stimulation via both cortical and deep implanted electrodes to attempt to halt a detected epileptiform discharge. One device, the Neuropace RNS System, is currently approved by the FDA and is commercially available. The system consists of an implantable neurostimulator, a cortical strip lead, a depth lead, a programmer and telemetry wand, and a patient data management system. Before the device is implanted, the patient undergoes seizure localization, which includes inpatient video- EEG monitoring and magnetic resonance imaging for detection of epileptogenic lesions. Additional testing may also include an EEG with intracranial electrodes, intraoperative or extraoperative stimulation with subdural electrodes, additional imaging studies, and/or neuropsychological testing and intracarotid amytal (Wada) testing. The selection and location of the leads are based on the location of seizure foci. Cortical strip leads are recommended for seizure foci on the cortical surface, while the depth leads are recommended for seizure foci beneath the cortical surface. The implantable neurostimulator and cortical and/or depth leads are implanted intracranially. The neurostimulator is initially programmed in the operating room to detect electrocorticographic activity. Responsive therapy is initially set up using standard parameters from the electrodes from which electrical activity is detected. Over time, the responsive stimulation settings are adjusted on the basis of electrocorticography data, which are collected by the patient through interrogation of the device with the telemetry wand and transmitted to the data management system. 11 Responsive Neurostimulation for Seizure Monitoring Although the intent of the electrocorticography component of the RNS system is to provide input as a trigger for neurostimulation, it also provides continuous seizure mapping data (chronic unlimited cortical electrocorticography [CURE]) that may be used by practitioners to evaluate patients seizures. In particular, the seizure mapping data have been used for surgical planning for patients who do not experience adequate seizure reduction with RNS placement. Several studies have described the use of the RNS in evaluating seizure foci for epilepsy surgery 12 or for identifying whether seizure foci are unilateral. 13,14 This policy does not further address use of RNS for the exclusive purposes of seizure monitoring. Page 7 of 11

8 Summary of Evidence For individuals who have refractory partial (focal) epilepsy who receive responsive neurostimulation (RNS), the evidence includes 1 industry-sponsored randomized controlled trial (RCT), which was used for Food and Drug Administration approval of the NeuroPace RNS System, as well as case series. Relevant outcomes are symptoms, morbid events, quality of life, and treatment-related mortality and morbidity. The pivotal trial was well-designed and wellconducted. It reported that RNS is associated with improvements in mean seizure frequency in patients with refractory partial epilepsy, with an absolute difference in change in seizure frequency of about 20% between groups, though the percentage of treatment responders with at least a 50% reduction in seizures did not differ from sham control. Overall, the results suggested a modest reduction in seizure frequency in a subset of patients. The number of adverse events reported in the available studies is low, although the data on adverse events were limited because of small study samples. Generally, patients who are candidates for RNS are severely debilitated and have few other treatment options, so the benefits are likely high relative to the risks. In particular, patients who are not candidates for resective epilepsy surgery and have few treatment options may benefit from RNS. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. Ongoing and Unpublished Clinical Trials Some currently unpublished trials that might influence this review are listed in Table 1. Table 1. Summary of Key Trials NCT No. Trial Name Planned Ongoing NCT a RNS System Long-term Treatment (LTT) Clinical Investigation Enrollment Completion Date 230 May 2018 NCT a RNS System Post-Approval Study in Epilepsy 375 May 2023 NCT: national clinical trial. a Denotes industry-sponsored or cosponsored trial. Page 8 of 11

9 Clinical Input Received from Physician Specialty Societies and Academic Medical Centers While the various physician specialty societies and academic medical centers may provide appropriate reviewers who collaborate with and make recommendations during this process, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted. In response to requests, input was received from 2 specialty medical societies (3 responses) and 5 academic medical centers (4 responses) when this policy was under development in There was consensus among reviewers that responsive neurostimulation is medically necessary for patients with partial epilepsy with 1 to 2 foci who are not candidates for resective epilepsy surgery. 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. Regulatory Status In November 2013, the NeuroPace RNS System (Neuropace Inc., Mountain View, CA) was approved by FDA through the premarket approval process for the following indication 15 : The RNS System is an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures (motor partial seizures, complex partial seizures and/ or secondarily generalized seizures). The RNS System has demonstrated safety and effectiveness in patients who average 3 or more disabling seizures per month over the three most recent months (with no month with fewer than two seizures), and has not been evaluated in patients with less frequent seizures. FDA product code: PFN. Page 9 of 11

10 References 1. Fisher RS, Cross JH, French JA, et al. Operational classification of seizure types by the International League Against Epilepsy: Position Paper of the ILAE Commission for Classification and Terminology. Epilepsia. Apr 2017;58(4): PMID Heck CN, King-Stephens D, Massey AD, et al. Two-year seizure reduction in adults with medically intractable partial onset epilepsy treated with responsive neurostimulation: final results of the RNS System Pivotal trial. Epilepsia. Mar 2014;55(3): PMID Costa J, Fareleira F, Ascencao R, et al. Clinical comparability of the new antiepileptic drugs in refractory partial epilepsy: a systematic review and meta-analysis. Epilepsia. Jul 2011;52(7): PMID Wiebe S, Blume WT, Girvin JP, et al. A randomized, controlled trial of surgery for temporal-lobe epilepsy. N Engl J Med. 2001;345(5): PMID de Tisi J, Bell GS, Peacock JL, et al. The long-term outcome of adult epilepsy surgery, patterns of seizure remission, and relapse: a cohort study. Lancet. Oct ;378(9800): PMID Noe K, Sulc V, Wong-Kisiel L, et al. Long-term outcomes after nonlesional extratemporal lobe epilepsy surgery. JAMA Neurol. Aug 2013;70(8): PMID Fridley J, Thomas JG, Navarro JC, et al. Brain stimulation for the treatment of epilepsy. Neurosurg Focus. Mar 2012;32(3):E13. PMID Fisher RS. Therapeutic devices for epilepsy. Ann Neurol. Feb 2012;71(2): PMID Kossoff EH, Ritzl EK, Politsky JM, et al. Effect of an external responsive neurostimulator on seizures and electrographic discharges during subdural electrode monitoring. Epilepsia. Dec 2004;45(12): PMID Anderson WS, Kossoff EH, Bergey GK, et al. Implantation of a responsive neurostimulator device in patients with refractory epilepsy. Neurosurg Focus. Sep 2008;25(3):E12. PMID NeuroPace. RNS System User Manual; Revision Date 04/ ; Accessed June DiLorenzo DJ, Mangubat EZ, Rossi MA, et al. Chronic unlimited recording electrocorticography-guided resective epilepsy surgery: technology-enabled enhanced fidelity in seizure focus localization with improved surgical efficacy. J Neurosurg. Jun 2014;120(6): PMID King-Stephens D, Mirro E, Weber PB, et al. Lateralization of mesial temporal lobe epilepsy with chronic ambulatory electrocorticography. Epilepsia. Jun 2015;56(6): PMID Spencer D, Gwinn R, Salinsky M, et al. Laterality and temporal distribution of seizures in patients with bitemporal independent seizures during a trial of responsive neurostimulation. Epilepsy Res. Feb 2011;93(2-3): PMID FDA. Summary of Safety and Effectiveness Data: RNS System 2013; Accessed June Morrell MJ, Group RNSSiES. Responsive cortical stimulation for the treatment of medically intractable partial epilepsy. Neurology. Sep ;77(13): PMID Loring DW, Kapur R, Meador KJ, et al. Differential neuropsychological outcomes following targeted responsive neurostimulation for partial-onset epilepsy. Epilepsia. Nov 2015;56(11): PMID Meador KJ, Kapur R, Loring DW, et al. Quality of life and mood in patients with medically intractable epilepsy treated with targeted responsive neurostimulation. Epilepsy Behav. Apr 2015;45: PMID Cox JH, Seri S, Cavanna AE. Clinical utility of implantable neurostimulation devices as adjunctive treatment of uncontrolled seizures. Neuropsychiatr Dis Treat. 2014;10: PMID Page 10 of 11

11 20. Gooneratne IK, Green AL, Dugan P, et al. Comparing neurostimulation technologies in refractory focal-onset epilepsy. J Neurol Neurosurg Psychiatry. Nov 2016;87(11): PMID Bergey GK, Morrell MJ, Mizrahi EM, et al. Long-term treatment with responsive brain stimulation in adults with refractory partial seizures. Neurology. Feb ;84(8): PMID Lee B, Zubair MN, Marquez YD, et al. A single-center experience with the neuropace rns system: a review of techniques and potential problems. World Neurosurg. Sep 2015;84(3): PMID Child ND, Stead M, Wirrell EC, et al. Chronic subthreshold subdural cortical stimulation for the treatment of focal epilepsy originating from eloquent cortex. Epilepsia. Mar 2014;55(3):e PMID Morris GL, 3rd, Gloss D, Buchhalter J, et al. Evidence-based guideline update: vagus nerve stimulation for the treatment of epilepsy: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. Oct ;81(16): PMID History Date Comments 01/13/15 New Policy. Policy created with literature review through June 30, 2014 and review of clinical input. Responsive neurostimulation may be considered medically necessary for refractory partial epilepsy when criteria are met. Reformatted the policy guidelines for improved clarification. 07/01/16 Annual Review, approved on June 14, Policy updated with literature review through February 9, 2016; references 12 and added. Policy statements unchanged. 07/01/17 Annual Review, approved on June 22, Policy updated with literature review through February 23, 2017; reference 19 added. Removed CPT codes and Policy statements unchanged. 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 11 of 11

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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 Washington. 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 (TTY: ). 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 Washington. 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 (TTY: ). Pусский (Russian): Настоящее уведомление содержит важную информацию. Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через LifeWise Health Plan of Washington. 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 (TTY: ). 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 Washington, 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 (TTY: ). 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 Washington. 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 (TTY: ). 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 Washington. 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 (TTY: ). 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 Washington และอาจม ก าหนดการในประกาศ น ค ณอาจจะต องด าเน นการภายในก าหนดระยะเวลาท แน นอนเพ อจะร กษาการประก นส ขภาพของค ณ หร อการช 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 Washington. 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. Дзвоніть за номером телефону (TTY: ). Tiếng Việt (Vietnamese): Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua chương trình LifeWise Health Plan of Washington. Xin xem ngày quan trọng trong thông báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn để duy trì bảo hiểm sức khỏe hoặc được trợ giúp thêm về chi phí. Quý vị có quyền được biết thông tin này và được trợ giúp bằng ngôn ngữ của mình miễn phí. Xin gọi số (TTY: ).