Preimplantation Genetic Testing in Embryos

Transcription

1 MEDICAL POLICY Preimplantation Genetic Testing in Embryos BCBSA Ref. Policy: * Effective Date: Oct. 1, 2017 Last Revised: Sept. 21, 2017 Replaces: & RELATED MEDICAL POLICIES: Infertility and Reproductive Services Genetic Testing for Developmental Delay/Intellectual Disability, Autism Spectrum Disorder, and Congenital Anomalies Genetic Testing of CADASIL Syndrome Genetic Testing for Hereditary Hearing Loss Invasive Prenatal (Fetal) Diagnostic Testing Genetic Testing for Alpha Thalassemia 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 In vitro fertilization is the process of combining eggs and sperm in a lab dish to create a fertilized egg (an embryo) and later implanting it into the uterus to complete the pregnancy. Before implantation, one or more cells from the embryo may be tested to see if there are problems with its genes or chromosomes. Preimplantation genetic diagnosis testing looks at the genes to see if the embryo carries a genetic disease such as cystic fibrosis. Preimplantation genetic screening looks to see if there are too few or too many chromosomes. This policy describes when either type of preimplantation genetic testing 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.

2 Policy Coverage Criteria Note: Preimplantation genetic diagnosis (PGD) is performed on embryos created as a result of in vitro fertilization (IVF) cycles. This procedure tests for specific diseases such as cystic fibrosis and would be covered as part of the member s infertility benefit, if applicable. Please check member contract and benefit descriptions for coverage. Procedure Preimplantation genetic diagnosis (PGD) Medical Necessity The procedure to obtain the cell sample for PGD (ie, the embryo biopsy) is considered medically necessary when the criteria below for PGD are met. However, the IVF procedure (ie, the procedures and services, including intracytoplasmic sperm injection [ICSI], required to create the embryos to be tested and the transfer of the appropriate embryos back to the uterus after testing) is covered only for persons with assisted fertility benefits for IVF. Please check the member contract and benefit descriptions for coverage of assisted fertility techniques such as IVF. Preimplantation genetic diagnosis (PGD) may be considered medically necessary as an alternative to amniocentesis or chorionic villus sampling in fertile couples undergoing IVF who meet one of the following criteria: For evaluation of an embryo at an identified elevated risk of a genetic disorder such as when: o Both partners are known carriers of a single-gene autosomal recessive disorder o One partner is a known carrier of a single-gene autosomal recessive disorder and the partners have an offspring who has been diagnosed with that recessive disorder o One partner is a known carrier of a single-gene autosomal dominant disorder o One partner is a known carrier of a single X-linked disorder OR For evaluation of an embryo at an identified elevated risk of structural chromosomal abnormality such as if one parent has a Page 2 of 13

3 Procedure Preimplantation genetic screening (PGS), gender selection Medical Necessity balanced or unbalanced chromosomal translocation Preimplantation genetic screening (PGS) is considered not medically necessary when testing embryos solely for nonmedical gender selection or selection of other nonmedical traits. Procedure Preimplantation genetic diagnosis (PGD) Preimplantation genetic screening (PGS) Investigational Preimplantation genetic diagnosis (PGD) as an alternative to amniocentesis or chorionic villus sampling is considered investigational in patients/couples who are undergoing IVF in all situations other than those specified above. Preimplantation genetic screening (PGS) as an alternative to amniocentesis or chorionic villus sampling is considered investigational in patients/couples who are undergoing IVF in all situations when used to screen for potential genetic abnormalities in couples without a specific known inherited disorder. Coding Code Description CPT ASPA (aspartoacylase) (eg, Canavan disease) gene analysis, common variants (e.g., E285A, Y231X) CFTR (cystic fibrosis transmembrane conductance regulator) (eg, cystic fibrosis) gene analysis; full gene sequence HEXA (hexosaminidase A [alpha polypeptide]) (eg, Tay-Sachs disease) gene analysis, common variants (eg, 1278insTATC, G>C, G269S) HBA1/HBA2 (alpha globin 1 and alpha globin 2) (eg, alpha thalassemia, Hb Bart hydrops fetalis syndrome, HbH disease), gene analysis, for common deletions or variant (eg, Southeast Asian, Thai, Filipino, Mediterranean, alpha3.7, alpha4.2, alpha20.5, and Constant Spring) Unlisted multianalyte assay with algorithmic analysis Page 3 of 13

4 Code Description Biopsy, oocyte polar body or embryo blastomere, microtechnique (for preimplantation genetic diagnosis); less than or equal to 5 embryos Biopsy, oocyte polar body or embryo blastomere, microtechnique (for preimplantation genetic diagnosis); greater than 5 embryos Unlisted reproductive medicine laboratory procedure 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). Specific CPT codes describe the embryo biopsy procedure ( ). Additional CPT codes will be required for the genetic analysis and will vary by technique used to perform the genetic analysis. Related Information Definition of Terms Benign: Not harmful to the DNA sequence. Disease-associated variant: A disease-associated change in the DNA sequence (also known as a mutation). Familial variant: A disease-associated variant identified in an index patient for use in subsequent targeted genetic testing of first-degree relatives. Likely benign: Unlikely to be a disease-causing change to the DNA sequence. Likely pathogenic: Likely a disease-causing change in the DNA sequence. Pathogenic: Disease-causing change in the DNA sequence. Preimplantation genetic diagnosis (PGD): Genetic testing to look for a specific disease, eg, cystic fibrosis. Preimplantation genetic screening (PGS): Genetic testing to see if the embryo has the normal number of chromosomes Preimplantation genetic testing (PGT): An umbrella term including preimplantation genetic diagnosis and preimplantation genetic screening Page 4 of 13

5 Variant of uncertain significance: A change in the DNA sequence with uncertain effects on disease. Variant: A change in the DNA sequence. Formerly called a mutation. Source: ACMG: American College of Medical Genetics and Genomics; AMP: Association for Molecular Pathology Genetic Counseling Genetic counseling is primarily aimed at patients who are at risk for inherited disorders, and experts recommend formal genetic counseling in most cases when genetic testing for an inherited condition is considered. The interpretation of the results of genetic tests and the understanding of risk factors can be very difficult and complex. Therefore, genetic counseling will assist individuals in understanding the possible benefits and harms of genetic testing, including the possible impact of the information on the individual s family. Genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing. Genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods. Additional Information In some cases involving a single X-linked disorder, determination of the gender of the embryo provides sufficient information for excluding or confirming the disorder. The severity of the genetic disorder is also a consideration. At present, many cases of preimplantation genetic diagnosis (PGD) have involved lethal or severely disabling conditions with limited treatment opportunities, such as Huntington chorea or Tay-Sachs disease. Cystic fibrosis is another condition for which PGD has been frequently performed. However, cystic fibrosis has a variable presentation and can be treatable. The range of genetic testing that is performed on amniocentesis samples as a possible indication for elective abortion may serve as a guide. This policy does not address the myriad ethical issues associated with preimplantation genetic testing (PGT) that, it is hoped, have involved careful discussion between the treated couple and the physician. For some couples, the decision may involve the choice between the risks of an in vitro fertilization procedure and deselection of embryos as part of the PGT treatment versus normal conception with the prospect of amniocentesis and an elective abortion. Page 5 of 13

6 Evidence Review Description Preimplantation genetic testing (PGT) involves analysis of biopsied cells as part of an assisted reproductive procedure. It is generally considered to be divided into two categories: 1. Preimplantation genetic diagnosis (PGD) is used to detect a specific inherited disorder and aims to prevent the birth of affected children in couples at high risk of transmitting a disorder 2. Preimplantation genetic screening (PGS) is used to screen for chromosomal aneuploidy in conjunction with in vitro fertilization for couples without a specific known inherited disorder Background Preimplantation genetic testing (PGT) describes a variety of adjuncts to an assisted reproductive procedure in which either maternal or embryonic DNA is sampled and genetically analyzed, thus permitting deselection of embryos harboring a genetic defect before implantation of an embryo into the uterus. The ability to identify preimplantation embryos with genetic defects before implantation provides an alternative to amniocentesis, chorionic villus sampling (CVS), and selective pregnancy termination of affected fetuses. PGT is generally categorized as either diagnostic (preimplantation genetic diagnosis [PGD]) or screening (preimplantation genetic screening [PGS]). PGD is used to detect genetic evidence of a specific inherited disorder, in the oocyte or embryo, derived from mother or couple, respectively, that has a high risk of transmission. PGS is not used to detect a specific abnormality but instead uses similar techniques to identify a number of genetic abnormalities in the absence of a known heritable disorder. This terminology, however, is not used consistently (eg, some authors use PGD when testing for a number of possible abnormalities in the absence of a known disorder). Embryos at Risk for a Specific Inherited Single Genetic Defect Inherited single-gene defects fall into 3 general categories: autosomal recessive, autosomal dominant, and X-linked. When either the mother or father is a known carrier of a genetic defect, Page 6 of 13

7 embryos can undergo PGD to deselect embryos harboring the defective gene. Sex selection of a female embryo is another strategy when the mother is a known carrier of an X-linked disorder for which there is no specific molecular diagnosis. The most common example is female carriers of fragile X syndrome. In this scenario, PGD is used to deselect male embryos, half of which would be affected. PGD could also be used to deselect affected male embryos. While there is a growing list of single genetic defects for which molecular diagnosis is possible, the most common indications include cystic fibrosis, β-thalassemia, muscular dystrophy, Huntington disease, hemophilia, and fragile X disease. It should be noted that when PGD is used to deselect affected embryos, the treated couple is not technically infertile but is undergoing an assisted reproductive procedure for the sole purpose of PGD. In this setting, PGD may be considered an alternative to selective termination of an established pregnancy after diagnosis by amniocentesis or CVS. Embryos at a Higher Risk of Translocations Balanced translocations occur in 0.2% of the neonatal population but at a higher rate in infertile couples or in those with recurrent spontaneous abortions. PGD can be used to deselect embryos carrying the translocations, thus leading to an increase in fecundity or a decrease in the rate of spontaneous abortion. Identification of Aneuploid Embryos Implantation failure of fertilized embryos is common in assisted reproductive procedures; aneuploidy of embryos is thought to contribute to implantation failure and may also be the cause of recurrent spontaneous abortion. The prevalence of aneuploid oocytes increases in older women. These age-related aneuploidies are mainly due to nondisjunction of chromosomes during maternal meiosis. Therefore, PGS has been explored as a technique to deselect aneuploid oocytes in older women. FISH analysis of extruded polar bodies from the oocyte or no blastomeres at day 3 of embryo development was the initial method used to detect aneuploidy. A limitation of FISH is that analysis is limited to a restricted number of proteins. More recently, newer PGS methods have been developed and are known collectively as PGS version 2. These methods allow for all chromosomes analysis with genetic platforms including array comparative genomic hybridization and single-nucleotide variant chain reaction analysis. Moreover, in addition to older women, PGS has been proposed for women with repeated implantation failure. Page 7 of 13

8 Summary of Evidence For individuals who have an identified elevated risk of a genetic disorder undergoing in vitro fertilization who receive preimplantation genetic diagnosis (PGD), the evidence includes observational studies and systematic reviews. Relevant outcomes are health status measures and treatment-related morbidity. Data from observational studies and a systematic review have suggested that PGD is associated with the birth of unaffected fetuses when performed for detection of single genetic defects and is associated with a decrease in spontaneous abortions for patients with structural chromosomal abnormalities. Moreover, PGD performed for single gene defects does not appear to be associated with increased risk of obstetric complications. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome. For individuals who have no identified elevated risk of a genetic disorder undergoing in vitro fertilization who receive preimplantation genetic screening (PGS), the evidence includes randomized controlled trials (RCTs) and meta-analyses. Relevant outcomes are health status measures and treatment-related morbidity. RCTs and meta-analyses of RCTs on initial PGS methods (eg, fish in situ hybridization) have found lower or similar ongoing pregnancy and live birth rates compared with in vitro fertilization without PGS. There are fewer RCTs on newer PGS methods, and findings are mixed. Meta-analyses of RCTs have found higher implantation rates with PGS than with standard care, but not live birth rates. One meta-analysis, but not the other, found significantly higher ongoing pregnancy rates after PGS than after standard care. Wellconducted RCTs evaluating PGS in the target population (eg, women of advanced maternal age) are needed before conclusions can be drawn about the impact on the net health benefit. 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 review are listed in Table 1. Table 1. Summary of Key Trials NCT No. Trial Name Planned Completion Enrollment Date Ongoing NCT a Single Embryo TrAnsfeR of Euploid Embryo (STAR) 600 Jun 2017 Page 8 of 13

9 NCT No. Trial Name Planned Enrollment Completion Date (ongoing) NCT A Study of Preimplantation Genetic Screening With Next Generation Sequencing Technology on Advanced Age Women 239 Aug 2019 NCT: national clinical trial. a Denotes industry-sponsored or cosponsored trial. Practice Guidelines and Position Statements American Society for Reproductive Medicine (ASRM) In 2013, the American Society for Reproductive Medicine published an opinion on the use of preimplantation genetic diagnosis (PGD) for serious adult onset conditions. 20 The main points included: - Preimplantation genetic diagnosis (PGD) for adult-onset conditions is ethically justifiable when the conditions are serious and when there are no known interventions for the conditions or the available interventions are either inadequately effective or significantly burdensome. - For conditions that are less serious or of lower penetrance, PGD for adult onset conditions is ethically acceptable as a matter of reproductive liberty. It should be discouraged, however, if the risks of PGD are found to be more than merely speculative. The opinion also stated that physicians and patients should be aware that much remains unknown about the long-term effects of embryo biopsy on the developing fetus and that experienced genetic counselors should be involved in the decision process. Previously, in 2007, the Society issued an opinion that concluded the available evidence did not support the use of preimplantation genetic screening as currently performed to improve live birth rates in patients with advanced maternal age, previous implantation failure, or recurrent pregnancy loss, or to reduce miscarriage rates in patients with recurrent pregnancy loss related to aneuploidy. 21 Page 9 of 13

10 American College of Obstetricians and Gynecologists (ACOG) In 2009 (reaffirmed in 2014), the ACOG issued an opinion on PGS for aneuploidy. 22 The College stated that current data do not support the use of PGS to screen for aneuploidy due solely to maternal age. The College also did not recommend PGS for recurrent unexplained miscarriage and recurrent implantation failures in the clinical setting; it recommended that use be limited to research studies. 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. Treff NR, Fedick A, Tao X, et al. Evaluation of targeted next-generation sequencing-based preimplantation genetic diagnosis of monogenic disease. Fertil Steril. Apr 2013;99(5): e1376. PMID Martin J, Cervero A, Mir P, et al. The impact of next-generation sequencing technology on preimplantation genetic diagnosis and screening. Fertil Steril. Mar ;99(4): e1053. PMID Franssen MT, Musters AM, van der Veen F, et al. Reproductive outcome after PGD in couples with recurrent miscarriage carrying a structural chromosome abnormality: a systematic review. Hum Reprod Update. Jul-Aug 2011;17(4): PMID Hasson J, Limoni D, Malcov M, et al. Obstetric and neonatal outcomes of pregnancies conceived after preimplantation genetic diagnosis: cohort study and meta-analysis. Reprod Biomed Online. Aug 2017;35(2): PMID Rubio C, Bellver J, Rodrigo L, et al. In vitro fertilization with preimplantation genetic diagnosis for aneuploidies in advanced maternal age: a randomized, controlled study. Fertil Steril. May 2017;107(5): PMID Page 10 of 13

11 6. Kato K, Aoyama N, Kawasaki N, et al. Reproductive outcomes following preimplantation genetic diagnosis using fluorescence in situ hybridization for 52 translocation carrier couples with a history of recurrent pregnancy loss. J Hum Genet. Aug 2016;61(8): PMID Chow JF, Yeung WS, Lee VC, et al. Experience of more than 100 preimplantation genetic diagnosis cycles for monogenetic diseases using whole genome amplification and linkage analysis in a single centre. Hong Kong Med J. Aug 2015;21(4): PMID Keymolen K, Staessen C, Verpoest W, et al. Preimplantation genetic diagnosis in female and male carriers of reciprocal translocations: clinical outcome until delivery of 312 cycles. Eur J Hum Genet. Apr 2012;20(4): PMID Scriven PN, Flinter FA, Khalaf Y, et al. Benefits and drawbacks of preimplantation genetic diagnosis (PGD) for reciprocal translocations: lessons from a prospective cohort study. Eur J Hum Genet. Oct 2013;21(10): PMID Strom CM, Strom S, Levine E, et al. Obstetric outcomes in 102 pregnancies after preimplantation genetic diagnosis. Am J Obstet Gynecol. Jun 2000;182(6): PMID Mastenbroek S, Twisk M, van der Veen F, et al. Preimplantation genetic screening: a systematic review and meta-analysis of RCTs. Hum Reprod Update. Jul-Aug 2011;17(4): PMID Dahdouh EM, Balayla J, Garcia-Velasco JA. Impact of blastocyst biopsy and comprehensive chromosome screening technology on preimplantation genetic screening: a systematic review of randomized controlled trials. Reprod Biomed Online. Mar 2015;30(3): PMID Yang Z, Liu J, Collins GS, et al. Selection of single blastocysts for fresh transfer via standard morphology assessment alone and with array CGH for good prognosis IVF patients: results from a randomized pilot study. Mol Cytogenet. May ;5(1):24. PMID Forman EJ, Hong KH, Ferry KM, et al. In vitro fertilization with single euploid blastocyst transfer: a randomized controlled trial. Fertil Steril. Jul 2013;100(1): e101. PMID Scott RT, Jr., Upham KM, Forman EJ, et al. Blastocyst biopsy with comprehensive chromosome screening and fresh embryo transfer significantly increases in vitro fertilization implantation and delivery rates: a randomized controlled trial. Fertil Steril. Sep 2013;100(3): PMID Dahdouh EM, Balayla J, Garcia-Velasco JA. Comprehensive chromosome screening improves embryo selection: a meta-analysis. Fertil Steril. Dec 2015;104(6): PMID Chen M, Wei S, Hu J, et al. Can comprehensive chromosome screening technology improve IVF/ICSI outcomes? a meta-analysis. PLoS One. Oct ;10(10):e PMID Beukers F, van der Heide M, Middelburg KJ, et al. Morphologic abnormalities in 2-year-old children born after in vitro fertilization/intracytoplasmic sperm injection with preimplantation genetic screening: follow-up of a randomized controlled trial. Fertil Steril. Feb 2013;99(2): PMID Schendelaar P, Middelburg KJ, Bos AF, et al. The effect of preimplantation genetic screening on neurological, cognitive and behavioural development in 4-year-old children: follow-up of a RCT. Hum Reprod. Jun 2013;28(6): PMID Ethics Committee of the American Society for Reproductive Medicine. Use of preimplantation genetic diagnosis for serious adult onset conditions: a committee opinion. Fertil Steril. Jul 2013;100(1): PMID Preimplantation genetic testing: a Practice Committee opinion. Fertil Steril. Dec 2007;88(6): PMID ACOG Committee Opinion No. 430: preimplantation genetic screening for aneuploidy. Obstet Gynecol. Mar 2009, reaffirmed 2014;113(3): PMID History Page 11 of 13

12 Date Comments 03/11/08 Add to OB-GYN Reproduction section. - Policy reinstated from 2002 Deleted status. Policy statement revised to remove reference to infertility conditions. Testing of embryos for nonmedical gender selection or nonmedical traits added as not medically necessary. New PR Policy. 08/11/09 Replace Policy - Policy updated with literature search. Policy statement revised to delete medically necessary bullet: Prior parental history of offspring with aneuploidy. Advanced maternal age, i.e., age greater than 35 years in the egg donor. Prior history of recurrent spontaneous abortion with uncertain genetic karyotype. References added. 02/09/10 Code Update - New 2010 code added. 08/10/10 Replace Policy - Policy updated with literature search. Rationale updated. References added. No change to policy statement. 07/12/11 Replace Policy - Policy updated with literature search. Rationale updated. Reference added. No change to policy statement. 01/11/12 Codes 81200, , , and added. 09/11/12 Replace policy. Policy changed to BCBSA (replacing ) and renumbered , moving to the Genetic Testing section. Policy title changed to Preimplantation Genetic Testing. Policy updated with literature search through May Two medical necessary statements added: When one partner is a known carrier of a single gene autosomal recessive disorder and the partners have one offspring that has been diagnosed with that recessive disorder and when there is partner with documented history of aneuploidy in a previous pregnancy. Statement added that PGD is investigational in all instances other than those listed. PGS, previously considered not medically necessary in patients/couples when used to screen for potential genetic abnormalities in couples without a specific known inherited disorder, is now considered investigational. Other policy statements unchanged. References 1, 2, 3, 4, 6 and 7 added; other references renumbered or removed. 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 /09/13 Replace policy. Policy statement revised to delete Partner with documented history of aneuploidy in a previous pregnancy as indication for elevated risk of chromosomal abnormality. Description and Rationale revised. References added. 11/21/13 Update Related Policies. Add /19/13 Update Related Policies. Add /24/14 Update Related Policies. Remove Page 12 of 13

13 Date Comments 09/23/14 Annual Review. No changes to policy statements. Added reference /03/14 Update Related Policies. Add /22/14 Update Related Policies. Add /08/15 Annual Review. Severity of genetic disorder determination paragraph deleted from policy guidelines as beyond the scope of this policy. Policy updated with literature review through June 3, References added; others renumbered/removed. Policy statements unchanged. Coding update: Deleted CPT codes removed; 89290, and removed reviewed under fertility benefit; , 81224, 81243, 81244, and removed since these are not reviewed pertaining to this policy. 05/04/16 Update related policies was deleted and replaced with /01/16 Annual Review, approved October 11, Policy updated with literature review through July 7, 2016; references 4-5 and added. Policy statements unchanged. 02/07/17 Coding correction. CPT code was previously listed on this policy in error. Code corrected to /01/17 Annual Review, approved September 21, Policy updated with literature review through June 22, 2017; references 4-5 added. Added CPT codes and Policy statements unchanged. *This policy varies slightly from the BCBSA reference policy. 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 13 of 13

14 Discrimination is Against the Law LifeWise Health Plan of Washington complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. LifeWise does not exclude people or treat them differently because of race, color, national origin, age, disability or sex. LifeWise: Provides free aids and services to people with disabilities to communicate effectively with us, such as: Qualified sign language interpreters Written information in other formats (large print, audio, accessible electronic formats, other formats) Provides free language services to people whose primary language is not English, such as: Qualified interpreters Information written in other languages If you need these services, contact the Civil Rights Coordinator. If you believe that LifeWise has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator - Complaints and Appeals PO Box 91102, Seattle, WA Toll free , Fax , TTY AppealsDepartmentInquiries@LifeWiseHealth.com You can file a grievance in person or by mail, fax, or . If you need help filing a grievance, the Civil Rights Coordinator is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue SW, Room 509F, HHH Building Washington, D.C , , (TDD) Complaint forms are available at Getting Help in Other Languages This Notice has Important Information. This notice may have important information about your application or coverage through LifeWise Health Plan of Washington. There may be key dates in this notice. You may need to take action by certain deadlines to keep your health coverage or help with costs. You have the right to get this information and help in your language at no cost. Call (TTY: ). አማሪኛ (Amharic): ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ LifeWise Health Plan of Washington ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎት በስልክ ቁጥር (TTY: ) ይደውሉ (Arabic): العربية يحوي ھذا اإلشعار معلومات ھامة. قد يحوي ھذا اإلشعار معلومات مھمة بخصوص طلبك أو التغطية التي تريد الحصول عليھا من خالل.LifeWise Health Plan of Washington قد تكون ھناك تواريخ مھمة في ھذا اإلشعار. وقد تحتاج التخاذ إجراء في تواريخ معينة للحفاظ على تغطيتك الصحية أو للمساعدة في دفع التكاليف. يحق لك الحصول على ھذه المعلومات والمساعدة بلغتك دون تكبد أية تكلفة. اتصل ب( (TTY: 中文 (Chinese): 本通知有重要的訊息 本通知可能有關於您透過 LifeWise Health Plan of Washington 提交的申請或保險的重要訊息 本通知內可能有重要日期 您可能需要在截止日期之前採取行動, 以保留您的健康保險或者費用補貼 您有權利免費以您的母語得到本訊息和幫助 請撥電話 (TTY: ) Oromoo (Cushite): Beeksisni kun odeeffannoo barbaachisaa qaba. Beeksisti kun sagantaa yookan karaa LifeWise Health Plan of Washington tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu danda a. Guyyaawwan murteessaa ta an beeksisa kana keessatti ilaalaa. Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu danda a. Kaffaltii irraa bilisa haala ta een afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu. Lakkoofsa bilbilaa (TTY: ) tii bilbilaa. Français (French): Cet avis a d'importantes informations. Cet avis peut avoir d'importantes informations sur votre demande ou la couverture par l'intermédiaire de LifeWise Health Plan of Washington. Le présent avis peut contenir des dates clés. Vous devrez peut-être prendre des mesures par certains délais pour maintenir votre couverture de santé ou d'aide avec les coûts. Vous avez le droit d'obtenir cette information et de l aide dans votre langue à aucun coût. Appelez le (TTY: ). Kreyòl ayisyen (Creole): Avi sila a gen Enfòmasyon Enpòtan ladann. Avi sila a kapab genyen enfòmasyon enpòtan konsènan aplikasyon w lan oswa konsènan kouvèti asirans lan atravè LifeWise Health Plan of Washington. Kapab genyen dat ki enpòtan nan avi sila a. Ou ka gen pou pran kèk aksyon avan sèten dat limit pou ka kenbe kouvèti asirans sante w la oswa pou yo ka ede w avèk depans yo. Se dwa w pou resevwa enfòmasyon sa a ak asistans nan lang ou pale a, san ou pa gen pou peye pou sa. Rele nan (TTY: ). Deutsche (German): Diese Benachrichtigung enthält wichtige Informationen. Diese Benachrichtigung enthält unter Umständen wichtige Informationen bezüglich Ihres Antrags auf Krankenversicherungsschutz durch LifeWise Health Plan of Washington. Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung. Sie könnten bis zu bestimmten Stichtagen handeln müssen, um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten. Sie haben das Recht, kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten. Rufen Sie an unter (TTY: ). Hmoob (Hmong): Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb. Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm LifeWise Health Plan of Washington. Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no. Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd. Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj. Hu rau (TTY: ). Iloko (Ilocano): Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion. Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti LifeWise Health Plan of Washington. Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar. Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos. Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo. Tumawag iti numero nga (TTY: ). Italiano (Italian): Questo avviso contiene informazioni importanti. Questo avviso può contenere informazioni importanti sulla tua domanda o copertura attraverso LifeWise Health Plan of Washington. Potrebbero esserci date chiave in questo avviso. Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione. Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente. Chiama (TTY: ) ( )

15 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: ). (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 Washington 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 Washington. 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 (TTY: ). 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: ).