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CLINICAL GUIDELINESLab Management ProgramEffective March 1, 2017CareCore National, LLC d/b/a eviCore healthcare (eviCore)Clinical guidelines for medical necessity review of lab management services. 2017 eviCore healthcare. All rights reserved.

Lab Management GuidelinesV1.0.2017Please note the following:CPT Copyright 2015 American Medical Association. All rights reserved.CPT is a registered trademark of the American Medical Association. 2017 eviCore healthcare. All Rights Reserved.2 of 511400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924www.eviCore.com

Lab Management GuidelinesV1.0.2017Please note the following:All information provided by the NCCN is “Referenced with permission fromthe NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ) 2016 National Comprehensive Cancer Network. The NCCN Guidelines and illustrations herein may not be reproduced in any form for any purposewithout the express written permission of the NCCN. To view the mostrecent and complete version of the NCCN Guidelines, go online toNCCN.org.” 2017 eviCore healthcare. All Rights Reserved.3 of 511400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924www.eviCore.com

Lab Management GuidelinesV1.0.2017Dear Provider,This document provides detailed descriptions of eviCore’s basic criteria for laboratoryservices. These criteria are used for the certification of requests and administration oflaboratory benefits for our clients for a range of laboratory tests some of which arerepresented by one CPT or HCPCS code and others represented by several codes.They have been carefully researched and are continually updated in order to beconsistent with the most current evidence-based guidelines and recommendations forlaboratory testing from national and international medical societies and evidence-basedmedicine research centers. In addition, the criteria are supplemented by informationpublished in peer reviewed literature. If you believe that our criteria require modification,please send suggested changes with supporting references to the LaboratoryManagement Program at the address listed below.Our health plan clients review the development and application of these criteria. EveryeviCore health plan client develops a unique list of CPT codes that are part of theirutilization management programs. Health Plan medical policy supersedes eviCore whenthere is conflict with the eviCore criteria and the health plan medical policy. If you areunsure of whether or not a specific health plan has made modifications to these basiccriteria in their medical policy please contact the plan or access the plan’s website foradditional information.eviCore works hard to make your clinical review experience a pleasant one. For thatreason, we have peer reviewers available to assist you should you have specificquestions about a procedure. For your convenience, eviCore’s Customer Servicesupport is available from 7 a.m. to 7 p.m. Our toll-free number is 1-800-918-8924.Gregg P. Allen, M. D. FAAFPEVP and Chief Medical Officer 2017 eviCore healthcare. All Rights Reserved.4 of 511400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924www.eviCore.com

Lab Management GuidelinesV1.0.2017General Information about This PolicyManualDescriptionThe eviCore healthcare (eviCore) policy manual contains medical and reimbursementpolicies that are created and approved by eviCore’s Laboratory Management Programpersonnel and policy advisors, internal Medical Advisory Committee, and externalMedical Advisory Board. eviCore’s polices are created using evidence-based medicineincluding, but not limited to, professional society guidelines, consensus statements, andpeer-reviewed literature. eviCore’s policies are intended to provide a library for adoptionor a basis for development of tailored coverage criteria for a Health Plan.PurposeTo establish evidence-based definitions, decision support, medical necessity criteria,coverage limitations, and payment rules for molecular and genetic testing.This manual is organized into the following sections:Molecular and Genetic Clinical Use PoliciesThe policies in this section are intended to provide general policy guidance for thecommon settings and scenarios in which genetic testing is used (e.g. prenatal,diagnostic, cancer). These policies address the overarching coverage principles thatbroadly apply based on the purpose of the test. They also address specific usesituations that may apply to many different tests (e.g. predictive testing for a knownfamilial mutation).Each of these overarching policies includes an inventory of all available test-specificpolicies that apply to that use. For example, the Pharmacogenomic Testing policyincludes a list of all policies for tests that may be used to assess drug response ortoxicity risk. Because tests can be used for multiple purposes, the same test-specificpolicy may be referenced by more than one Clinical Use Policy. However, when a testspecific policy is not available, the overarching coverage principles found in theseClinical Use Policies may be applied.Molecular and Genetic Test Specific PoliciesThe policies in this section address a test or group of tests that are used to assesssome health condition. The purpose of these policies is to provide a framework fordetermining medical necessity and coverage determinations for a specific test, includingwhere more limited testing may be supported by the medical evidence when broadertesting is not. These policies provide background about each condition, the availabletests, the scenarios in which the test may be used, and the evidence used to determinemedical necessity criteria. 2017 eviCore healthcare. All Rights Reserved.5 of 511400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924www.eviCore.com

Lab Management GuidelinesV1.0.2017GlossaryThis glossary contains definitions for common genetics, medical and laboratoryterminologyAdministrative PoliciesIf applicable for this plan, administrative policies are included that define coding andreimbursement criteria and requirements.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 policies contained in this manual are the proprietary property ofeviCore, for use by its clients only. These medical policies may not be posted,shared, altered, cited or reproduced without the express written consent of eviCore.Commercial use of these policies is prohibited. Medical policies are not to be considered medical advice for a specific patient.Policies are used in the process of determining whether a service may be medicallynecessary and eligible for coverage. Medical Policies are interpreted and applied at the sole discretion of the Health Plan. Current Procedural Terminology (CPT ) codes and descriptions are the property ofthe American Medical Association with all rights reserved. 2017 eviCore healthcare. All Rights Reserved.6 of 511400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924www.eviCore.com

Lab Management GuidelinesV1.0.2017Table of ContentsPolicyPageMolecular and Genetic Clinical Use Policies. 10Genetic Testing for Cancer Susceptibility and Hereditary Cancer Syndromes . 11Genetic Testing for Carrier Status . 13Genetic Testing for Non-Medical Purposes . 16Genetic Testing for Prenatal Screening and Diagnostic Testing . 18Genetic Testing for the Screening, Diagnosis, and Monitoring of Cancer . 21Genetic Testing to Diagnose Non-Cancer Conditions . 23Genetic Testing to Predict Disease Risk . 25Genetic Testing by Multigene Panels . 27Investigational and Experimental Molecular/Genomic Testing . 32Pharmacogenomic Testing for Drug Toxicity and Response. 38Preimplantation Genetic Screening and Diagnosis . 40Molecular and Genetic Test-Specific Policies . 434Kscore for Prostate Cancer Risk Assessment . 44ABL Tyrosine Kinase Sequencing for Chronic Myeloid Leukemia. 47Afirma Gene Expression Classifier for Thyroid Cancer . 50AlloMap Gene Expression Profiling For Heart Transplant Rejection . 54Alpha-1-Antitrypsin Deficiency Testing . 58Amyotrophic Lateral Sclerosis (ALS) Genetic Testing . 61Angelman Syndrome Testing . 68Anser ADA and Anser IFX . 75APOE Variant Analysis for Alzheimer Disease . 78Ashkenazi Jewish Carrier Screening . 81Ataxia-Telangiectasia . 88BCR-ABL Testing for Chronic Myeloid Leukemia . 92Bloom Syndrome Testing . 95BRAF Testing for Colorectal Cancer . 101BRAF Testing for Melanoma Kinase Inhibitor Response . 103BRCA Ashkenazi Jewish Founder Mutation Testing . 106BRCA Known Familial Mutation Analysis . 111BRCA1/2 Deletion/Duplication Analysis . 114BRCA Sequencing . 118BRCA Sequencing for Olaparib Response . 125Brugada Syndrome Known Familial Mutation Analysis . 129Brugada Syndrome Multigene Panels . 133Brugada Syndrome Sequencing . 137CADASIL Known Familial Mutation Analysis . 141CADASIL Testing . 145Canavan Disease Testing . 149Celiac Disease Testing . 154CellSearch Circulating Tumor Cell Count for Breast Cancer Prognosis . 156Charcot-Marie-Tooth Neuropathy Testing Panel . 158Chromosomal Microarray Testing For Developmental Disorders . 162Chromosomal Microarray for Prenatal Diagnosis . 167Chromosome Analysis for Blood, Bone Marrow, and Solid Tumor Cancers . 171Cologuard Screening for Colorectal Cancer . 173ConfirmMDx for Prostate Cancer Risk Assessment . 178Corus CAD for Obstructive Coronary Artery Disease . 181CYP2C9 and VKORC1 Testing for Warfarin Response . 187CYP2C19 Variant Analysis for Clopidogrel Response . 191 2017 eviCore healthcare. All Rights Reserved.7 of 511400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924www.eviCore.com