DNA-Based Testing for Adolescent Idiopathic Scoliosis

Transcription

1 MEDICAL POLICY DNA-Based Testing for Adolescent Idiopathic Scoliosis BCBSA Ref. Policy: Effective Date: May 1, 2018 Last Revised: April 3, 2018 Replaces: RELATED MEDICAL POLICIES: None 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 Scoliosis is a condition in which the spine abnormally curves to the side. The abnormal curving starts for no known reason (it is idiopathic ), and usually begins in adolescence. The curve may be mild or severe, but most of the time it is not painful and does not cause any problems. However, if the curve becomes severe it can put pressure on the lungs and heart. This can make it harder to breathe and affect how well the heart can pump blood. Severe curvature may need to be corrected with surgery. A genetic test (ScoliScore ) has been developed that is supposed to predict whether a child s mild to moderate scoliosis will become severe. Medical studies have not shown that this test is effective or helpful in managing patients. For this reason, genetic testing for idiopathic scoliosis is considered to be unproven (investigational). 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.

2 Policy Coverage Criteria Testing Testing for adolescent idiopathic scoliosis Investigational DNA-based prognostic testing for adolescent idiopathic scoliosis is considered investigational. Coding Note: The ScoliScore AIS (adolescent idiopathic scoliosis) prognostic DNA-based test is a saliva-based genetic test designed to predict the risk of progression of scoliosis in patients with AIS. The provider is Axial Biotech, Salt Lake City, UT (aka, Transgenomic, Omaha, NE). Code CPT 0004M Description Scoliosis, DNA analysis of 53 single nucleotide polymorphisms (SNPs), using saliva, prognostic algorithm reported as a risk score Unlisted multianalyte assay with algorithmic analysis 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 Genetic Counseling Experts recommend formal genetic counseling for patients who are at risk for inherited disorders and who wish to undergo genetic testing. Interpreting the results of genetic tests and understanding risk factors can be difficult for some patients. Genetic counseling helps individuals understand the impact of genetic testing, including the possible effects the test results could have on the individual or their family members. It should be noted that genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing; further, genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods. Page 2 of 10

3 Benefit Application These pathology tests are commercially available only at a single reference laboratory, Transgenomic. Evidence Review Description Adolescent idiopathic scoliosis (AIS) is a disease of unknown etiology that causes mild-to-severe spinal deformity in approximately 1% to 3% of adolescents. While there is controversy about the value of screening and treatment, patients are frequently closely followed once they have been diagnosed. In cases with significant progression of curvature, both medical (bracing) and surgical (spinal fusion) interventions are considered. The ScoliScore AIS prognostic DNA-based test uses an algorithm incorporating results of testing for 53 single-nucleotide variants (SNVs), along with the patient s presenting spinal curve (Cobb angle), to generate a risk score (range, 1-200). This score can be used qualitatively or quantitatively to predict the likelihood of spinal curve progression. Background Adolescent Idiopathic Scoliosis Adolescent idiopathic scoliosis (AIS) is the most common pediatric spinal deformity, affecting 1% to 3% of adolescents. 1 This disease of unknown etiology occurs in otherwise healthy children with the onset of, and highly correlated with, the adolescent growth spurt. The vertebrae become misaligned such that the spine deviates laterally in a C or S shape. Although AIS affects females and males in a nearly 1:1 ratio, progression to severe deformity occurs more often in females. Because the disease can have a rapid onset and produce considerable morbidity, school screenings have been recommended. However, screening remains somewhat controversial, with conflicting guidelines supporting and not supporting this practice.. Page 3 of 10

4 Diagnosis Diagnosis is established by radiologic observation in adolescents (age 10 years until the age of skeletal maturity) of a lateral spine curvature of 10 or more, as measured using the Cobb angle. 2 The Cobb angle is defined as the angle measured between the maximally tilted proximal and distal vertebrae of the curve. The curvature is considered mild (<25 ), moderate (25-40 ), or severe (>40 ) in a patient who is still growing. Once diagnosed, patients must be monitored over several years, usually with serial radiographs, for curve progression. Treatment If the curve progresses, spinal bracing is the generally accepted first-line treatment. If the curve progresses in spite of bracing, spinal fusion may be recommended. Curve progression has been linked to a number of factors, including sex, curve magnitude, patient age, and skeletal maturity. Risk tables, by Lonstein and Carlson (1984) 3 and Peterson and Nachemson (1995) 4, help in triage and treatment decision making about patients with AIS. Tan et al. (2009) compared a broad array of factors and concluded that Initial Cobb angle magnitude is the most important predictor of long-term curve progression and behavior past skeletal maturity. Additionally, they suggest that an initial Cobb angle of 25 (was) an important threshold magnitude for long-term curve progression. 5 Genetic Associations and Scoliosis The familial nature of this disease was noted as early as About one-quarter of patients report a positive family history of disease, and twin studies have consistently supported shared genetic factors. 1 Genome-wide linkage studies have reported multiple chromosomal regions of interest, often not replicated. Ogilvie (2010) has suggested AIS is a complex polygenic trait. 7 Ogilvie et al published a study evaluating an algorithm using 53 single-nucleotide variants (SNV) markers identified from unpublished genome-wide association studies (GWAS) in order to differentiate patients unlikely to exhibit severe progression in curvature from those at considerable risk for severe progression. The clinical validity of this assay has recently been reported in a 2010 retrospective case-control cohort study using this algorithm. 2 Page 4 of 10

5 ScoliScore AIS The ScoliScore AIS prognostic DNA-based test (Transgenomic), uses an algorithm incorporating results of testing for 53 SNVs, along with the patient s presenting spinal curve (Cobb angle), to generate a risk score (range, 1-200) that can be used qualitatively or quantitatively to predict the likelihood of spinal curve progression. The test is intended for Caucasian patients, aged 9 to 13 years, with a primary diagnosis of AIS with a mild scoliotic curve (defined as <25 ). The development and validation of the ScoliScore SNV-based prognostic algorithm were described in 2010 by Ward et al in the industry-sponsored study discussed above. 2 The prognostic algorithm was developed in a cohort of 2192 female patients from prior studies. Candidate genes were selected based on previous genome-wide association studies data from the same investigators. The independent effect of each SNV and of clinical factors (initial Cobb angle) and all gene-gene interaction terms were tested in a stepwise logistic regression using a backward-selection procedure and then using a forward-selection procedure. The final predictive model included 53 SNV markers, multiple gene-gene interaction terms, and the patient s initial Cobb angle. Prediction probabilities were converted to a numeric score ranging from 1 to 200. A priori, low risk of progression was determined to be less than 1%; from the generation cohort, a score of less than 41 was selected as an initial cutoff. The ScoliScore AIS Prognostic Test was originally developed by Axial Biotech with test rights acquired by Transgenomic in In 2015, Transgenomic divested its Genetic Assays & Platforms Business Unit to ADSTEC Corp. 8 In June 2017, Transgenomic was acquired by Precipio Diagnostics in a reverse merger transaction. 9 It does appear that the test remains commercially available. Summary of Evidence For individuals with AIS who receive clinical management with prognostic testing using an algorithm incorporating SNV-based testing, the evidence includes cross-sectional studies reporting on the clinical validity of the ScoliScore test, along with cross-sectional studies reporting on the association with SNVs in various genes and scoliosis progression. Relevant outcomes are symptoms, morbid events, and change in disease status. A single study on the clinical validity for the ScoliScore AIS prognostic DNA-based test has reported a high negative predictive value for ruling out the possibility of progression to severe curvature in a population with a low baseline likelihood of progression. It is not clear if the increase in predictive accuracy provided by testing is statistically or clinically meaningful. Other genetic studies have not demonstrated significant associations between the SNVs used in the ScoliScore and scoliosis Page 5 of 10

6 progression. Studies have identified additional SNVs that may be associated with AIS severity, but these associations have not been reliably replicated. The clinical validity of DNA-based testing (either through testing of individual SNVs or an algorithm incorporating SNV results) for predicting scoliosis progression in patients with AIS has not been established. There is no direct evidence demonstrating that use of this test results in changes in management that improve outcomes. The value of early identification and intervention(s) for people at risk for progression of disease and whether laboratory testing improves disease identification beyond clinical evaluation are unknown. The evidence is insufficient to determine the effects of the technology on health outcomes. Ongoing and Unpublished Clinical Trials Some currently unpublished trials that might influence this policy are listed in Table 1. Table 1. Summary of Key Trials NCT No. Trial Name Planned Completion Enrollment Date Unpublished NCT Genetic Evaluation for the Scoliosis Gene(s) in Patients With Neurofibromatosis 1 and Scoliosis 100 Aug 2015 (completed) NCT: national clinical trial. 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 societies and 4 academic medical centers while this policy was under review in All agreed with this policy and indicated that DNA-based prognostic testing for AIS (ScoliScore ) should be considered investigational. Page 6 of 10

7 Practice Guidelines and Position Statements In 2011, the International Scientific Society on Scoliosis Orthopaedic and Rehabilitation Treatment issued guidelines on the conservative treatment of idiopathic scoliosis. 22 These guidelines do not address the role of DNA-based prognostic testing. U.S. Preventive Services Task Force Recommendations In 2004, the U.S. Preventive Services Task Force (USPSTF) recommended against the routine screening of asymptomatic adolescents for idiopathic scoliosis (Grade D Recommendation). 23 This recommendation is currently being updated. No USPSTF recommendations for DNA-based testing for AIS were identified. 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 Clinical laboratories may develop and validate tests in-house and market them as a laboratory service; laboratory-developed tests (LDTs) must meet the general regulatory standards of the Clinical Laboratory Improvement Amendments (CLIA). Laboratories that offer LDTs must be licensed by CLIA for high-complexity testing. To date, the U.S. Food and Drug Administration has chosen not to require any regulatory review of this test. References 1. Weinstein SL, Dolan LA, Cheng JC, et al. Adolescent idiopathic scoliosis. Lancet. May ;371(9623): PMID Page 7 of 10

8 2. Ward K, Ogilvie JW, Singleton MV, et al. Validation of DNA-based prognostic testing to predict spinal curve progression in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). Dec ;35(25):E PMID Lonstein JE, Carlson JM. The prediction of curve progression in untreated idiopathic scoliosis during growth. J Bone Joint Surg Am. Sep 1984;66(7): PMID Peterson LE, Nachemson AL. Prediction of progression of the curve in girls who have adolescent idiopathic scoliosis of moderate severity. Logistic regression analysis based on data from The Brace Study of the Scoliosis Research Society. J Bone Joint Surg Am. Jun 1995;77(6): PMID Tan KJ, Moe MM, Vaithinathan R, et al. Curve progression in idiopathic scoliosis: follow-up study to skeletal maturity. Spine (Phila Pa 1976). Apr ;34(7): PMID Wynne-Davies R. Familial (idiopathic) scoliosis. A family survey. J Bone Joint Surg Br. Feb 1968;50(1): PMID Ogilvie J. Adolescent idiopathic scoliosis and genetic testing. Curr Opin Pediatr. Feb 2010;22(1): PMID BLL Partners LLC. Transgenomic Finalizes Divestment of its Genetic Assays & Platforms Business Unit. 2015; Accessed April Bloomberg. Life Sciences Tools and Services: Company Overview of Transgenomic, Inc. 2017; Accessed April Roye BD, Wright ML, Matsumoto H, et al. An independent evaluation of the validity of a DNA-based prognostic test for adolescent idiopathic scoliosis. J Bone Joint Surg Am. Dec ;97(24): PMID Roye BD, Wright ML, Williams BA, et al. Does ScoliScore provide more information than traditional clinical estimates of curve progression? Spine (Phila Pa 1976). Dec ;37(25): PMID Bohl DD, Telles CJ, Ruiz FK, et al. A genetic test predicts providence brace success for adolescent idiopathic scoliosis when failure is defined as progression to >45 degrees. Clin Spine Surg. Apr 2016;29(3):E PMID Tang QL, Julien C, Eveleigh R, et al. A replication study for association of 53 single nucleotide polymorphisms in ScoliScore test with adolescent idiopathic scoliosis in French-Canadian population. Spine (Phila Pa 1976). Apr ;40(8): PMID Xu L, Huang S, Qin X, et al. Investigation of the 53 markers in a DNA-based prognostic test revealing new predisposition genes for adolescent idiopathic scoliosis. Spine (Phila Pa 1976). Jul ;40(14): PMID Xu L, Qin X, Sun W, et al. Replication of association between 53 single-nucleotide polymorphisms in a DNA-based diagnostic test and AIS progression in Chinese Han population. Spine (Phila Pa 1976). Feb 2016;41(4): PMID Ogura Y, Takahashi Y, Kou I, et al. A replication study for association of 53 single nucleotide polymorphisms in a scoliosis prognostic test with progression of adolescent idiopathic scoliosis in Japanese. Spine (Phila Pa 1976). Jul ;38(16): PMID Noshchenko A, Hoffecker L, Lindley EM, et al. Predictors of spine deformity progression in adolescent idiopathic scoliosis: A systematic review with meta-analysis. World J Orthop. Aug ;6(7): PMID Sharma S, Gao X, Londono D, et al. Genome-wide association studies of adolescent idiopathic scoliosis suggest candidate susceptibility genes. Hum Mol Genet. Apr ;20(7): PMID Fendri K, Patten SA, Kaufman GN, et al. Microarray expression profiling identifies genes with altered expression in adolescent idiopathic scoliosis. Eur Spine J. Jun 2013;22(6): PMID Jiang J, Qian B, Mao S, et al. A promoter polymorphism of tissue inhibitor of metalloproteinase-2 gene is associated with severity of thoracic adolescent idiopathic scoliosis. Spine (Phila Pa 1976). Jan ;37(1): PMID Qiu Y, Mao SH, Qian BP, et al. A promoter polymorphism of neurotrophin 3 gene is associated with curve severity and bracing effectiveness in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). Jan ;37(2): PMID Negrini S, Aulisa AG, Aulisa L, et al SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis. Jan ;7(1):3. PMID Page 8 of 10

9 23. U.S. Preventive Services Task Force (USPSTF). Idiopathic Scoliosis in Adolescents: Screening. 2004; Accessed April History Date Comments 10/11/11 New Policy Add to Pathology/Laboratory section. Policy created with literature search through June 2011; considered investigational. 05/24/12 Policy renumbered to (previously ) and reassigned to new Genetic Testing category. 10/26/12 Replace policy. Rationale section revised based on literature review through June 2012 and results of clinical vetting. Reference 9 added. ICD-10 codes are now effective 10/01/2014. Code added. Policy statement unchanged. 01/14/13 Coding update. CPT codes deleted as of 12/31/12; CPT codes and 81599, effective 1/1/13, are added to the policy. 05/14/13 Update Related Policies. Add /12/13 Coding update. MAAA code 0004M added to the policy. 09/27/13 Replace policy. Policy updated with literature review through 6/18/13; reference 9 added; policy statement unchanged. 07/23/14 Update Related Policies. Remove /08/14 Annual Review. Policy updated with literature review through June 6, 2014; references added. No change to policy statement. 09/08/15 Annual Review. Added to the Appendix, Table 1. Categories of Genetic Testing Addressed in This Policy. Policy updated with literature review through June 1, 2015; reference 11 added. Policy statement unchanged. 11/01/16 Annual Review, approved October 11, Policy updated with literature review through September 15, 2016; reference 18 added. No change to policy statement. 04/01/17 Annual Review, approved March 14, Policy updated with literature review through November 7, 2016; references 9, 11, and added. Removed Appendix table. Policy statement unchanged. 09/22/17 Policy moved into new format. No changes to policy statements. 05/01/18 Annual Review, approved April 3, Policy updated with literature review through November 2017; references 8-9 added; note 22 updated. Policy statement unchanged. Page 9 of 10

10 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 10 of 10

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12 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 Washington 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 Washington 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 Washington. ອາດຈະມ ວ ນທ ສ າຄ ນໃນແຈ ງການນ. ທ ານອາດຈະຈ າເປ ນຕ ອງດ າ ເນ ນການຕາມກ ານ ດເວລາສະເພາະເພ ອຮ ກສາຄວາມຄ ມຄອງປະກ ນສ ຂະພາບ ຫ ຄວາມຊ 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 (TTY: ). 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 Washington 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 ថងជ 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 Washington 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 (TTY: ). 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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: ).