Genetic Testing. Yes when meets criteria below. Yes except for tests listed in 2.0.

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1 Genetic Testing MP9012 Covered Service: Prior Authorization Required: Additional Information: Yes when meets criteria below Yes except for tests listed in 2.0. None Prevea360 Health Plan Medical Policy: 1.0 All genetic tests other than those specified in 2.0 require prior authorization through the Quality and Care. 2.0 The following tests do not require prior authorization when performed by a Prevea360 Health Plan contracted lab. (Pre-testing and post-testing genetic counseling is always recommended for all genetic tests, but not required. Post-testing genetic counseling is strongly recommended when the tests listed below yield abnormal results). 2.1 Alpha and/or beta-thalasemia Screen; 2.2 Alpha-1 antitrypsin genotype; 2.3 Ashkenazi Jewish Carrier Screen; 2.4 Chromosome Analysis/Karyotype 2.5 Chromosome Analysis of leukemia 2.6 Cystic Fibrosis Carrier Screen; 2.7 Factor V Leiden/Prothrombin gene mutations; 2.8 FISH (florescent in situ hybridization) for chronic lymphocytic leukemia, chronic myeloid leukemia, or multiple myeloma. 2.9 Fragile X; 2.10 Hemochromatosis; 2.11 HNPCC screen (aka MSI/IHC); 2.12 Prenatal screening; (prenatal chromosome analysis) 2.13 Prenatal diagnostic tests (CVS, Amniocentesis) which are medically indicated based on OB/GYN or MFM specialist; 2.14 Tumor mutation analysis (EGFR, EML4-ALK, BRAF, C-KIT, KRAS, others) 2.15 JAK2 mutation analysis for hematologic disorders. 1 of 5 Underwritten by Dean Health Plan, Inc.

2 2.16 Hyperhomocysteinemia MTHFR Gene is covered when ordered by Obstetrics clinicians only 2.17 Inflammatory Bowel Disease TPMT Gene is covered when ordered by Gastroenterology clinicians only 3.0 A Clinical/Medical Genetics Evaluation requires prior authorization through the Quality and Care. 4.0 Multigene hereditary cancer panels that may or may not accompany BRCA testing are considered experimental/investigational and are not a covered benefit. There is insufficient published evidence of their clinical validity and utility. The BRCA testing portion of these panels may be considered medically necessary. General Information and Medical Necessity Guidelines for Genetic Testing: 5.0 In general, Genetic testing is a covered benefit for a Prevea360 Health Plan member, only if the test results provide direct medical benefit or guides reproductive decision making for the Prevea360 Health Plan member. 5.1 The member must meet at least one of the following criteria: There is documented reasonable expectation based on family history, pedigree analysis, risk factors, and/or symptoms that a genetically inherited or acquired condition exists and the member displays clinical features; or The member is asymptomatic but at direct risk of inheriting the mutation in question, a.k.a. pre-symptomatic testing. or The member is from the appropriate disease-specific population. 5.2 Informed consent is typically provided for all genetic tests. Informed consent indicates that the ordering clinician has discussed: The potential benefits, harms and limitations of the test to be ordered The implications of positive, negative or ambiguous results Members should have access to genetic counseling before proceeding with genetic testing. A referral to genetics counseling should be made when a positive, abnormal, or equivocal genetics test results is obtained. 5.3 Genetic testing must be FDA/CLIA approved and the clinical utility of the genetic test must be established. Whenever possible, genetic testing must be performed by approved Prevea360 Health Plan laboratories. 5.4 All genetic testing must be processed through a Prevea360 Health Plan provider phlebotomist and laboratory, unless otherwise specified by a Prevea360 Genetics Counselor. 6.0 Genetic testing of a Prevea360 Health Plan member s non-prevea360 relative may be a covered benefit if all of the following criteria are met: 2 of 5 Underwritten by Dean Health Plan, Inc.

3 6.1 The test results are for the direct medical benefit of the Prevea360 Health Plan member and testing the non-plan relative is the most cost effective method to obtain the medically necessary information for the Prevea360 Health Plan member. 6.2 The non-plan relative s insurance company has been billed and payment has been denied. 6.3 Prevea360 Health Plan coverage is limited to the testing of five non-plan relatives as a lifetime benefit for a Prevea360 Health Plan member. 6.4 Testing of the non-prevea360 Health Plan relative has been recommended by a genetics counselor and approved by a Prevea360 Health Plan medical director. 7.0 Genetic testing of children to predict adult onset diseases is not considered medically necessary unless the child is symptomatic, test results will guide current decisions concerning prevention, and/or this benefit would be lost by waiting until the child has reached adulthood. 8.0 The following tests are considered experimental/investigational or not medically necessary and therefore not covered: 8.1 Amyotrophic Lateral Sclerosis (ALS)-SOD1 Gene all indications; 8.2 CancerNext and CancerNext Expanded gene panels all indications; 8.3 Clopidogrel Pharmacogenetics-CYP2C19 Gene all indications; 8.4 Coronary artery disease gene expression testing all indications; 8.5 Fecal DNA Screening for Colorectal Cancer; 8.6 Genetic testing for initial Warfarin dose for Genetic testing for variantscyp2c9 and VKORC1 genes in patients starting warfarin; 8.7 Genomic Wide Association Studies all indications; 8.8 Hyperhomocysteinemia-MTHR Gene; (CPT code 81291) 8.9 Irinotecan Dosing-UGT1A1 Gene all indications; 8.10 Macular Degeneration Risk Genetic Testing (i.e. Vita Risk, Macular Risk PGx) Genetic testing to determine risk of macular degeneration; 8.11 MSR1, TMPRSS-ETS Fusion and PCA3 Genes all indications; 8.12 Pancreatic Cancer Genetic Testing Panels all indications; 8.13 Prostate Cancer Genetic Profiles-BRCA2 all indications; 8.14 Spinal Fluid DNA analysis for Apolipoprotein E epsilon 4 genotype (apoe) for susceptibility to Alzheimer s disease Whole genome sequencing/whole exome sequencing testing is considered experimental / investigational. 3 of 5 Underwritten by Dean Health Plan, Inc.

4 8.16 Psychotropic Medication Pharmacogenetics Gene Panels (e.g. Genesight) 8.17 Comprehensive next generation sequencing of genes associated with cancer (e.g.foundationone) Committee/Source Date(s) Originated: QA/UR Committee December 18, 1991 Revised: Utilization Management Committee/Genetics Work Group Utilization Management Committee/ Health Services Utilization Management Committee/ Medical Affairs Dept. Utilization Management Committee/ Genetics Testing Work Group Utilization Management Committee/Genetics Counsel. Utilization Management Committee/Medical Affairs Utilization Management Committee/Medical Affairs March 4, 1998 March 10, 1999 April 12, 2000 August 9, 2000 November 11, 2000 May 12, 2004 January 14, 2009 January 18, 2012 April 18, 2012 August 15, 2012 September 19, 2012 January 16, 2013 June 13, 2013 February 19, 2014 April 15, 2015 May 20, 2015 December 16, 2015 February 17, 2016 September 21, 2016 October 31, of 5 Underwritten by Dean Health Plan, Inc.

5 Reviewed: Committee/Source Managed Care Division/ Medical Affairs Department Utilization Management Committee/CMO/UM Director Reformatted UM Committee (UMC)/Director UM/ UMC Chair UM Committee (UMC)/Director UM/ UMC Chair Date(s) April 11, 2001 March 13, 2002 March 12, 2003 March 10, 2004 March 9, 2005 September 2005 March 8, 2006 March 14, 2007 March 12, 2008 April 8, 2009 February 24, 2011 January 18, 2012 April 18, 2012 August 15, 2012 September 19, 2012 January 16, 2013 June 13, 2013 January 15, 2014 February 19, 2014 January 21, 2015 April 15, 2015 May 20,2015 December 16, 2015 February 17, 2016 September 17, 2016 October 31, 2016 Published: 11/01/2016 Genetic Testing Prior Authorization Form 5 of 5 Underwritten by Dean Health Plan, Inc.