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CLINICAL GUIDELINESLab Management ProgramEffective January 1, 2021Clinical guidelines for medical necessity review of lab management services. 2020 eviCore healthcare. All rights reserved.

1199SEIU Benefit Funds Lab Management GuidelinesV1.0.2021Please note the following:CPT Copyright 2020 American Medical Association. All rights reserved. CPT is a registeredtrademark of the American Medical Association. 2020 eviCore healthcare. All Rights Reserved.400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-89242 of 1252www.eviCore.com

1199SEIU Benefit Funds Lab Management GuidelinesV1.0.2021Please note the following:All information provided by the NCCN is “Referenced with permission from the NCCN ClinicalPractice Guidelines in Oncology (NCCN Guidelines ) 2017, 2018, 2019, and 2020 NationalComprehensive Cancer Network. The NCCN Guidelines and illustrations herein may not bereproduced in any form for any purpose without the express written permission of the NCCN.To view the most recent and complete version of the NCCN Guidelines, go online toNCCN.org.” 2020 eviCore healthcare. All Rights Reserved.400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-89243 of 1252www.eviCore.com

1199SEIU Benefit Funds Lab Management GuidelinesV1.0.2021General Information About thisGuideline ManualDescriptionThe eviCore healthcare (eviCore) guideline manual contains medical andreimbursement guidelines that are created and approved by eviCore’s LaboratoryManagement Program personnel and advisors, internal Medical Advisory Committee,and external Medical Advisory Board. eviCore’s guidelines are created using evidencebased medicine including, but not limited to, professional society guidelines, consensusstatements, and peer-reviewed literature. eviCore’s guidelines are intended to providea library for adoption or a basis for development of tailored coverage criteria for aHealth Plan.PurposeTo establish evidence-based definitions, decision support, medical necessity criteria,coverage limitations, and payment rules for molecular and genetic testing.OrganizationThis manual is organized into the following sections.Molecular and Genetic Clinical Use GuidelinesThe guidelines in this section are intended to provide general guidance for the commonsettings and scenarios in which genetic testing is used (e.g. prenatal, diagnostic,cancer). These guidelines address the overarching coverage principles that broadlyapply based on the purpose of the test. They also address specific use situations thatmay apply to many different tests (e.g. predictive testing for a known familial mutation).Clinical Use guidelines may include a test-specific guidelines section to direct users toany relevant test-specific guidelines. Because tests may be used for multipleindications, the same test-specific guideline may be referenced by more than oneClinical Use guideline. When a test specific guideline is not available, the coverageprinciples found in these Clinical Use Guidelines will be applied.Molecular and Genetic Test Specific GuidelinesThe guidelines in this section address a test or group of tests that are used to assesssome health condition. The purpose of these guidelines is to provide a framework fordetermining medical necessity and coverage determinations for a specific test,including where more limited testing may be supported by the medical evidence whenbroader testing is not. These guidelines provide background about each condition, theavailable tests, the scenarios in which the test may be used, and the evidence used todetermine medical necessity criteria. 2020 eviCore healthcare. All Rights Reserved.400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-89244 of 1252www.eviCore.com

1199SEIU Benefit Funds Lab Management GuidelinesV1.0.2021Administrative GuidelinesIf applicable for this plan, administrative guidelines are included that define coding andreimbursement criteria and requirements.GlossaryThis glossary contains definitions for common genetics, medical and laboratoryterminology.Limitations and RestrictionsWhen using this manual in electronic or printed form, the following restrictions apply: Evidence-based genetic testing is defined as the identification of targeted geneticsequences within the genome of an individual with clinically-identified risk factors ortraits suspected of being specific to the genetic disorder, condition, or trait underinvestigation. The medical guidelines contained in this manual are the proprietary property ofeviCore, for use by its clients only. These medical guidelines may not be posted,shared, altered, cited or reproduced without the express written consent of eviCore.Commercial use of these guidelines is prohibited. Medical guidelines are not to be considered medical advice for a specific patient.Guidelines are used in the process of determining whether a service may bemedically necessary and eligible for coverage. Medical Guidelines are interpreted and applied at the sole discretion of the HealthPlan. Current Procedural Terminology (CPT ) codes and descriptions are the property ofthe American Medical Association with all rights reserved. 2020 eviCore healthcare. All Rights Reserved.400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-89245 of 1252www.eviCore.com

1199SEIU Benefit Funds Lab Management GuidelinesV1.0.2021Table of ContentsGuidelinePageContentsMolecular and Genetic Clinical Use Guidelines.10Confirmatory Genetic Testing. 11Genetic Presymptomatic and Predictive Testing for Adult-Onset Conditions in Minors.13Genetic Testing by Multigene Panels. 16Genetic Testing for Cancer Susceptibility and Hereditary Cancer Syndromes.22Genetic Testing for Carrier Status. 25Genetic Testing for Known Familial Mutations.28Genetic Testing for Non-Medical Purposes. 31Genetic Testing for Prenatal Screening and Diagnostic Testing.33Genetic Testing for the Screening, Diagnosis, and Monitoring of Cancer.36Genetic Testing for Variants of Uncertain Clinical Significance.38Genetic Testing to Diagnose Non-Cancer Conditions.42Genetic Testing to Predict Disease Risk. 46Hereditary (Germline) Testing After Tumor (Somatic) Testing.49Investigational and Experimental Molecular and Genomic Testing.58Pharmacogenomic Testing for Drug Toxicity and Response.68Preimplantation Genetic Screening and Diagnosis.80Molecular and Genetic Test Specific Guidelines.824Kscore for Prostate Cancer Risk Assessment.83ABL Tyrosine Kinase Sequencing for Chronic Myeloid Leukemia.90Acute Myeloid Leukemia (AML) Genetic Testing.94Afirma Thyroid Cancer Classifier Tests. 100AlloMap Gene Expression Profiling for Heart Transplant Rejection.108AlloSure for Kidney Transplant Rejection. 113Alpha-1 Antitrypsin Deficiency Testing. 120Amyotrophic Lateral Sclerosis (ALS) Genetic Testing.126Angelman Syndrome Testing. 134Anser Testing. 143APOE Variant Analysis for Alzheimer Disease Testing.149Genetic Testing for Arrhythmogenic Right Ventricular Cardiomyopathy.153Ashkenazi Jewish Carrier Screening. 164Ataxia-Telangiectasia Testing. 173BCR-ABL Negative Myeloproliferative Neoplasm Testing.178BCR-ABL1 Testing for Chronic Myeloid Leukemia.187Bloom Syndrome Testing. 192BRCA Analysis. 200BRCA Ashkenazi Jewish Founder Mutation Testing.212Breast Cancer Index for Breast Cancer Prognosis.219Brugada Syndrome Genetic Testing. 225CADASIL Testing. 232Canavan Disease Testing. 239HLA Typing for Celiac Disease. 245CellSearch Circulating Tumor Cell Count for Breast Cancer Prognosis.251Charcot-Marie-Tooth Neuropathy Testing.256CHARGE Syndrome Genetic Testing. 265Chromosomal Microarray for Prenatal Diagnosis.274Chromosomal Microarray for Solid Tumors. 280Chromosomal Microarray Testing For Developmental Disorders.286Chromosome Analysis for Reproductive Disorders, Prenatal Testing, and Developmental Disorders. . .294 2020 eviCore healthcare. All Rights Reserved.400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-89246 of 1252www.eviCore.com

1199SEIU Benefit Funds Lab Management GuidelinesV1.0.2021Chromosome Analysis for Blood and Bone Marrow Cancers.303Cologuard Screening for Colorectal Cancer.307ConfirmMDx for Prostate Cancer Risk Assessment.314Cxbladder. 319Cystic Fibrosis Testing. 324Genetic Testing for Dilated Cardiomyopathy.335Decipher Prostate Cancer Classifier. 345DecisionDx Uveal Melanoma. 353Dentatorubral-Pallidoluysian Atrophy Testing. 358DermTech Pigmented Lesion Assay. 364Duchenne and Becker Muscular Dystrophy Testing.369Early Onset Familial Alzheimer Disease (EOFAD) Genetic Testing.374Ehlers-Danlos Syndrome Testing. 381EndoPredict for Breast Cancer Prognosis. 401Expanded Carrier Screening Panels. 410Genetic Testing for Facioscapulohumeral Muscular Dystrophy.419Factor II/Prothrombin Testing for Thrombophilia.428Factor V Leiden Testing for Thrombophilia.434Familial Adenomatous Polyposis Testing. 443Familial Hypercholesterolemia Genetic Testing.449Familial Malignant Melanoma Testing. 460FibroTest/FibroSURE. 465Flow Cytometry. 472FMR1-Related Disorders (Fragile X) Genetic Testing.482Friedreich Ataxia Genetic Testing. 490Gaucher Disease Testing. 498GeneSight Psychotropic Test. 505Genetic Testing for Autism, Intellectual Disability, and Developmental Delay.514Genetic Testing for Epilepsy. 527Genetic Testing for Nonsyndromic Hearing Loss and Deafness.544Genitourinary Conditions Molecular Testing.555GPS Cancer (NantHealth). 585Hemoglobinopathies Genetic Testing. 587Hereditary Ataxia Multigene Panel Testing. 603Hereditary Cancer Syndrome Multigene Panels.611Hereditary Connective Tissue Disorder Testing.623HFE Hemochromatosis Testing. 637Genetic Testing for Hereditary Pancreatitis. 643HIV Tropism Testing for Maraviroc Response. 656Huntington Disease. 661Hypertrophic Cardiomyopathy Testing. 667Immunohistochemistry (IHC). 675In-vitro testing for HIV. 680In-vitro testing for SARS-CoV-2 (COVID-19). 692Laboratory Claim Reimbursement. 708Leber Hereditary Optic Neuropathy (LHON) Genetic Testing.717Legius Syndrome Genetic Testing. 725Li-Fraumeni Syndrome. 730Genetic Testing for Limb-Girdle Muscular Dystrophy.736Liquid Biopsy Testing. 746Long QT Syndrome Testing. 755Lyme Disease Testing. 762Lynch Syndrome Genetic Testing. 769Lynch Syndrome Tumor Screening - Second-Tier.781Macula Risk. 786Mammaprint 70-Gene Breast Cancer Recurrence Assay.790Mammostrat Breast Cancer Recurrence Assay.797Marfan Syndrome Genetic Testing.

Jan 01, 2021 · 1199SEIU Benefit Funds Lab Management Guidelines V1.0.2021 General Information About this Guideline Manual Description . The eviCore healthcare (eviCore) guideline manual contains medical and . reimbursement guidelines that are created and approved by eviCore’s Laboratory . Management Prog