Molecular Testing for the Management of Pancreatic Cysts or Barrett Esophagus

Transcription

1 MEDICAL POLICY Molecular Testing for the Management of Pancreatic Cysts or Barrett Esophagus Effective Date: Sept. 1, 2017 Last Revised: Aug. 22, 2017 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 Looking at tissue samples is one way to diagnose cancer. In some cases, though, tissue tests alone don t give clear enough information to make a diagnosis. This is when other types of tests can be used to diagnose cancer. In recent years, tests known as topographic genotyping have been tried. First, certain cells are taken from a tissue sample, and then the DNA is removed and analyzed. Then the information from the tissue test and the DNA test is combined to try to make a firm diagnosis of cancer. At this time, there are not enough published medical studies to show if diagnosing cancer this way leads to better health outcomes compared to other ways of diagnosing cancer. 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

2 Test PathFinderTG Investigational Molecular testing using the PathFinderTG system is considered investigational for all indications including the evaluation of pancreatic cyst fluidand Barrett esophagus. Coding Code Description CPT Unlisted molecular pathology procedure Unlisted multianalyte assay with algorithmic analysis Unlisted chemistry 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). Related Information N/A Evidence Review Description Tests that integrate microscopic analysis with molecular tissue analysis are generally called topographic genotyping. Interpace Diagnostics offers two such tests that use the PathFinderTG platform (eg, PancraGEN, BarreGEN). These molecular tests are intended to be used adjunctively when a definitive pathologic diagnosis cannot be made, because of inadequate specimen or equivocal histologic or cytologic findings, to inform appropriate surveillance or surgical strategies. Page 2 of 10

3 Background Topographic genotyping (TG), also called molecular anatomic pathology, integrates microscopic analysis (anatomic pathology) with molecular tissue analysis. Under microscopic examination of tissue and other specimens, areas of interest may be identified and microdissected to increase tumor cell yield for subsequent molecular analysis. TG may permit pathologic diagnosis when first-line analyses are inconclusive. 1 RedPath Integrated Pathology (now Interpace Diagnostics) has patented a proprietary platform called PathFinderTG that provides mutational analyses of patient specimens. The patented technology permits analysis of tissue specimens of any size, including minute needle biopsy specimens, and any age, including those stored in paraffin for over 30 years. 2 Interpace currently describes in detail on its website one PathFinderTG test called PancraGEN. It also describes another PathFinderTG test called BarreGEN as being in the pipeline (listed and briefly described in Table 1). 3 As stated on the company website, PancraGEN integrates molecular analyses with first-line results (when these are inconclusive) and pathologist interpretation. 4 The manufacturer calls this technique integrated molecular pathology. Test performance information is not provided on the website. Table 1. PathFinderTG Tests 5 Test Description Specimen Types PathFinderTG Pancreas Uses loss of heterozygosity markers, oncogene mutations, Pancreatobiliary fluid/ercp (now called PancraGEN) and DNA content abnormalities to stratify patients brush, pancreatic masses, or according to their risk of progression to cancer pancreatic tissue PathFinderTG Barrett (now called BarreGEN) Measures the presence and extent of genomic instability and integrates those results with histology Esophageal tissue ERCP, endoscopic retrograde cholangiopancreatography Ongoing and Unpublished Clinical Trials Some currently unpublished trials that might impact this policy are listed in Table 2. Page 3 of 10

4 Table 2. Summary of Key Trials NCT No. Trial Name Planned Completion Enrollment Date Ongoing NCT The Clinical, Radiologic, Pathologic and Molecular Marker 450 Sep 2017 Characteristics of Pancreatic Cysts Study (PCyst) NCT Integrated Molecular Analysis of Cancer in Gynaecologic Oncology (IMAC-GO) 700 Aug 2018 NCT Biomarker Analysis of Central Nervous System Tumors 500 Nov 2025 Unpublished NCT The Diagnostic Yield of Malignancy Comparing Cytology, FISH and Molecular Analysis of Cell Free Cytology Brush Supernatant in Patients With Biliary Strictures Undergoing Endoscopic Retrograde Cholangiography (ERC): A Prospective Study 110 Jan 2017 (unknown) NCT: national clinical trial. Summary of Evidence For individuals who have pancreatic cysts who do not have a definitive diagnosis after first-line evaluation and who receive standard diagnostic and management practices plus topographic genotyping (PancraGEN molecular testing), the evidence includes retrospective studies of clinical validity and clinical utility. Relevant outcomes are overall survival, disease-specific survival, test accuracy and validity, change in disease status, morbid events, and quality of life. The best evidence regarding incremental clinical validity comes from the National Pancreatic Cyst Registry report that compared PancraGEN performance characteristics to current international consensus guidelines and provided preliminary but inconclusive evidence of a small incremental benefit for PancraGEN. The analyses from the registry study included only a small proportion of enrolled patients, relatively short follow-up time for observing malignant transformation, and limited data on cases where the PancraGEN results are discordant with international consensus guidelines. The evidence is insufficient to determine the effects of the technology on health outcomes. For individuals who have Barrett esophagus who receive standard prognostic techniques plus topographic genotyping (BarreGEN molecular testing), the evidence includes 2 observational studies evaluating the performance characteristics of a panel of genetic markers in Barrett Page 4 of 10

5 esophagus. Relevant outcomes are overall survival, disease-specific survival, test accuracy and validity, change in disease status, morbid events, and quality of life. The studies showed that high mutational load could distinguish less from more severe histology and was a predictor of progression in Barrett esophagus. It is not clear if the test used was specifically BarreGEN or if the BarreGEN prognostic algorithm was applied for classification. The evidence is insufficient to determine the effects of the technology on health outcomes. Practice Guidelines and Position Statements American Gastroenterological Association In 2015, the American Gastroenterological Association (AGA) published a guideline on the diagnosis and management of asymptomatic neoplastic pancreatic cysts 8 based on findings from a technical review. 17 The technical review states the following about molecular testing: Case series have confirmed that malignant cysts have a greater number and quality of molecular alterations, but no study has been properly designed to identify how the test performs in predicting outcome with regard to need for surgery, surveillance, or predicting interventions leading to improved survival. The AGA guideline also stated Molecular techniques to evaluate pancreatic cysts remain an emerging area of research, and the diagnostic utility of these tests is uncertain. In 2011, AGA published a medical position statement on the management of Barrett esophagus. 47 Based on findings from a technical review, 51 AGA recommended against the use of molecular biomarkers to confirm the histological diagnosis of dysplasia or as a method of risk stratification for patients with Barrett s esophagus at this time (weak recommendation, lowquality evidence). American College of Gastroenterology The American College of Gastroenterology published guidelines on the diagnosis and management of Barrett esophagus in The guidelines stated: Given the complexity and diversity of alterations observed to date in the progression sequence, a panel of biomarkers may be required for risk stratification. At the present time, no biomarkers or panels of biomarkers are ready for clinical practice. In order to become part of the clinical armamentarium, biomarkers will have to be validated in large prospective cohorts. Page 5 of 10

6 National Comprehensive Cancer Network Current National Comprehensive Cancer Network guidelines for pancreatic adenocarcinoma, 52 central nervous system cancers, 53 esophageal and esophagogastric junction cancers, 54 and hepatobiliary cancers 55 do not include recommendations for molecular anatomic pathology or integrated molecular pathology. 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. The local coverage determination by Novatis Solutions is: PathfinderTG will be considered medically reasonable and necessary when selectively used as an occasional second-line diagnostic supplement: Only where there remains clinical uncertainty as to either the current malignancy or the possible malignant potential of the pancreatic cyst based upon a comprehensive first-line evaluation AND A decision regarding treatment (eg, surgery) has NOT already been made based on existing information. 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). Patented diagnostic tests (eg, PancraGEN ) are available only through Interpace Diagnostics (Pittsburgh, PA and New Haven, CT; formerly RedPath Integrated Pathology) under the auspices of 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. Page 6 of 10

7 References 1. Trikalinos T, Terasawa T, Raman G. A systematic review of loss-of-heterozygosity based topographic genotyping with PathfinderTG. AHRQ Technology Assessment Program 2010; Accessed August U.S. Patent #7,014,999. Finkelstein et al. March 21, Topographic genotyping. Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearchadv.htm&r=16&f=G&l=50&d=PTXT&S1=(redpath+AND+specimen)&OS=redpath+AND+specimen&RS=(redpath+AN D+specimen) Accessed August Interpace Diagnostics. Advancing patient care through molecular diagnostic testing. 2016; Accessed August Interpace Diagnostics. How PancraGEN works. 2016; Accessed August RedPath Integrated Pathology. Services. 2013; [Archived]. 6. Tanaka M, Fernandez-del Castillo C, Adsay V, et al. International consensus guidelines 2012 for the management of IPMN and MCN of the pancreas. Pancreatology. May-Jun 2012;12(3): PMID Tanaka M, Chari S, Adsay V, et al. International consensus guidelines for management of intraductal papillary mucinous neoplasms and mucinous cystic neoplasms of the pancreas. Pancreatology. 2006;6(1-2): PMID Vege SS, Ziring B, Jain R, et al. American Gastroenterological Association institute guideline on the diagnosis and management of asymptomatic neoplastic pancreatic cysts. Gastroenterology. Apr 2015;148(4): ; quize PMID Bennett C, Moayyedi P, Corley DA, et al. BOB CAT: a large-scale review and delphi consensus for management of Barrett's Esophagus with no dysplasia, indefinite for, or low-grade dysplasia. Am J Gastroenterol. May 2015;110(5): ; quiz 683. PMID Shaheen NJ, Falk GW, Iyer PG, et al. ACG Clinical Guideline: diagnosis and management of Barrett's esophagus. Am J Gastroenterol. Jan 2016;111(1):30-50; quiz 51. PMID de Oliveira PB, Puchnick A, Szejnfeld J, et al. Prevalence of incidental pancreatic cysts on 3 tesla magnetic resonance. PLoS One. Mar ;10(3):e PMID Laffan TA, Horton KM, Klein AP, et al. Prevalence of unsuspected pancreatic cysts on MDCT. AJR Am J Roentgenol. Sep 2008;191(3): PMID de Jong K, Nio CY, Hermans JJ, et al. High prevalence of pancreatic cysts detected by screening magnetic resonance imaging examinations. Clin Gastroenterol Hepatol. Sep 2010;8(9): PMID Gardner TB, Glass LM, Smith KD, et al. Pancreatic cyst prevalence and the risk of mucin-producing adenocarcinoma in US adults. Am J Gastroenterol. Oct 2013;108(10): PMID Khalid A, Brugge W. ACG practice guidelines for the diagnosis and management of neoplastic pancreatic cysts. Am J Gastroenterol. Oct 2007;102(10): PMID Oh HC, Kim MH, Hwang CY, et al. Cystic lesions of the pancreas: challenging issues in clinical practice. Am J Gastroenterol. Jan 2008;103(1): ; quiz 228, 240. PMID Scheiman JM, Hwang JH, Moayyedi P. American Gastroenterological Association technical review on the diagnosis and management of asymptomatic neoplastic pancreatic cysts. Gastroenterology. Apr 2015;148(4): e822. PMID Interpace Diagnostics. Clinical utility. 2016; Accessed August Page 7 of 10

8 19. Al-Haddad MA, Kowalski T, Siddiqui A, et al. Integrated molecular pathology accurately determines the malignant potential of pancreatic cysts. Endoscopy. Feb 2015;47(2): PMID Khalid A, McGrath KM, Zahid M, et al. The role of pancreatic cyst fluid molecular analysis in predicting cyst pathology. Clin Gastroenterol Hepatol. Oct 2005;3(10): PMID Khalid A, Nodit L, Zahid M, et al. Endoscopic ultrasound fine needle aspirate DNA analysis to differentiate malignant and benign pancreatic masses. Am J Gastroenterol. Nov 2006;101(11): PMID Khalid A, Pal R, Sasatomi E, et al. Use of microsatellite marker loss of heterozygosity in accurate diagnosis of pancreaticobiliary malignancy from brush cytology samples. Gut. Dec 2004;53(12): PMID Khalid A, Zahid M, Finkelstein SD, et al. Pancreatic cyst fluid DNA analysis in evaluating pancreatic cysts: a report of the PANDA study. Gastrointest Endosc. May 2009;69(6): PMID Siddiqui AA, Kowalski TE, Kedika R, et al. EUS-guided pancreatic fluid aspiration for DNA analysis of KRAS and GNAS mutations for the evaluation of pancreatic cystic neoplasia: a pilot study. Gastrointest Endosc. Apr 2013;77(4): PMID Schoedel KE, Finkelstein SD, Ohori NP. K-Ras and microsatellite marker analysis of fine-needle aspirates from intraductal papillary mucinous neoplasms of the pancreas. Diagn Cytopathol. Sep 2006;34(9): PMID Sawhney MS, Devarajan S, O'Farrel P, et al. Comparison of carcinoembryonic antigen and molecular analysis in pancreatic cyst fluid. Gastrointest Endosc. May 2009;69(6): PMID Sreenarasimhaiah J, Lara LF, Jazrawi SF, et al. A comparative analysis of pancreas cyst fluid CEA and histology with DNA mutational analysis in the detection of mucin producing or malignant cysts. JOP. Mar ;10(2): PMID Mertz H. K-ras mutations correlate with atypical cytology and elevated CEA levels in pancreatic cystic neoplasms. Dig Dis Sci. Jul 2011;56(7): PMID Talar-Wojnarowska R, Pazurek M, Durko L, et al. A comparative analysis of K-ras mutation and carcinoembryonic antigen in pancreatic cyst fluid. Pancreatology. Sep-Oct 2012;12(5): PMID Chai SM, Herba K, Kumarasinghe MP, et al. Optimizing the multimodal approach to pancreatic cyst fluid diagnosis: developing a volume-based triage protocol. Cancer Cytopathol. Feb 2013;121(2): PMID Nikiforova MN, Khalid A, Fasanella KE, et al. Integration of KRAS testing in the diagnosis of pancreatic cystic lesions: a clinical experience of 618 pancreatic cysts. Mod Pathol. Nov 2013;26(11): PMID Lapkus O, Gologan O, Liu Y, et al. Determination of sequential mutation accumulation in pancreas and bile duct brushing cytology. Mod Pathol. Jul 2006;19(7): PMID Tamura K, Ohtsuka T, Date K, et al. Distinction of invasive carcinoma derived from intraductal papillary mucinous neoplasms from concomitant ductal adenocarcinoma of the pancreas using molecular biomarkers. Pancreas. Jul 2016;45(6): PMID Gillis A, Cipollone I, Cousins G, et al. Does EUS-FNA molecular analysis carry additional value when compared to cytology in the diagnosis of pancreatic cystic neoplasm? A systematic review. HPB (Oxford). May 2015;17(5): PMID Panarelli NC, Sela R, Schreiner AM, et al. Commercial molecular panels are of limited utility in the classification of pancreatic cystic lesions. Am J Surg Pathol. Oct 2012;36(10): PMID Toll AD, Kowalski T, Loren D, et al. The added value of molecular testing in small pancreatic cysts. JOP. Nov ;11(6): PMID Kung JS, Lopez OA, McCoy EE, et al. Fluid genetic analyses predict the biological behavior of pancreatic cysts: three-year experience. JOP. Sep 2014;15(5): PMID Shen J, Brugge WR, Dimaio CJ, et al. Molecular analysis of pancreatic cyst fluid: a comparative analysis with current practice of diagnosis. Cancer. Jun ;117(3): PMID Deftereos G, Finkelstein SD, Jackson SA, et al. The value of mutational profiling of the cytocentrifugation supernatant fluid from fine-needle aspiration of pancreatic solid mass lesions. Mod Pathol. Apr 2014;27(4): PMID Page 8 of 10

9 40. Fasanella KE, McGrath KM, Sanders M, et al. Pancreatic endocrine tumor EUS-guided FNA DNA microsatellite loss and mortality. Gastrointest Endosc. May 2009;69(6): PMID Malhotra N, Jackson SA, Freed LL, et al. The added value of using mutational profiling in addition to cytology in diagnosing aggressive pancreaticobiliary disease: review of clinical cases at a single center. BMC Gastroenterol. Aug ;14:135. PMID Winner M, Sethi A, Poneros JM, et al. The role of molecular analysis in the diagnosis and surveillance of pancreatic cystic neoplasms. JOP. Mar ;16(2): PMID RedPath Integrated Pathology. National Pancreatic Cyst Registry. Accessed August Das A, Brugge W, Mishra G, et al. Managing incidental pancreatic cystic neoplasms with integrated molecular pathology is a cost-effective strategy. Endosc Int Open. Oct 2015;3(5):E PMID Loren D, Kowalski T, Siddiqui A, et al. Influence of integrated molecular pathology test results on real-world management decisions for patients with pancreatic cysts: analysis of data from a national registry cohort. Diagn Pathol. Jan ;11(1):5. PMID Kowalski T, Siddiqui A, Loren D, et al. Management of patients with pancreatic cysts: analysis of possible false-negative cases of malignancy. J Clin Gastroenterol. Sep 2016;50(8): PMID Spechler SJ, Sharma P, Souza RF, et al. American Gastroenterological Association medical position statement on the management of Barrett's esophagus. Gastroenterology. Mar 2011;140(3): PMID Yantiss RK. Diagnostic challenges in the pathologic evaluation of Barrett esophagus. Arch Pathol Lab Med. Nov 2010;134(11): PMID Khara HS, Jackson SA, Nair S, et al. Assessment of mutational load in biopsy tissue provides additional information about genomic instability to histological classifications of Barrett's esophagus. J Gastrointest Cancer. Jun 2014;45(2): PMID Eluri S, Brugge WR, Daglilar ES, et al. The presence of genetic mutations at key loci predicts progression to esophageal adenocarcinoma in Barrett's esophagus. Am J Gastroenterol. Jun 2015;110(6): PMID Spechler SJ, Sharma P, Souza RF, et al. American Gastroenterological Association technical review on the management of Barrett's esophagus. Gastroenterology. Mar 2011;140(3):e18-52; quiz e13. PMID National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology: pancreatic adenocarcinoma. Version Accessed August National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology: central nervous system cancers. Version Accessed August National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology: esophageal and esophagogastric junction cancers. Version Accessed August National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology: hepatobiliary cancers. Version Accessed August History Page 9 of 10

10 Date Comments 08/09/11 New Policy Add to Pathology/Laboratory section. 08/20/12 Replace policy. A literature review through May 2012 found no new studies; no references added. Policy statement unchanged. Policy moved to genetic testing section and renumbered from to /11/13 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 /24/13 Replace policy. Policy updated with literature search through March 15, 2013; no references added. Policy statement unchanged. 07/31/14 Annual Review. Policy updated with literature review through April 16, 2014; 2-4, 19-23, added; reference 1 updated. Barrett esophagus added to policy statement, which is otherwise unchanged. 07/14/15 Annual Review. Policy updated with literature review through April 29, 2015; references 5, 23, and added; reference 21 deleted. Policy statements unchanged. 10/01/16 Annual Review, approved September 13, Policy updated with literature review through June 14, 2016; references 3-4, 8-9, 11, 34, 36-38, 42-44, and 48 added. Tests not commercially available (PathFinderTG Glioma) removed from policy. 02/10/17 Policy moved into new format; no change to policy statements. 09/01/17 Annual Review, approved August 22, Policy updated with literature review through June 20, 2017; references 33 and 46 added. Policy statements unchanged. During the editorial review phase, the title of this policy was changed to Molecular Testing for the Management of Pancreatic Cysts or Barrett Esophagus. 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: ).