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Letter of Medical Necessity Test Code 1975 <<Today’s Date>> <<Insurance Company Name>> <<Address 1>> <<Address 2>> <<City, State ZIP>> Regarding: <<Patient full name>> DOB: <<MM/DD/YYYY>> Subscriber ID: <<Member ID#>> Group ID: <<Group ID#>> Re: Request for prior authorization and coverage for Hereditary Colorectal Cancer genetic testing. Billing is through <<billing institution>> with testing performed at PreventionGenetics, LLC. CPT codes for PreventionGenetics test code #1975 include: 81408, 81479 (x12), 81295, 81297, 81298, 81300, 81406 (x3), 81321, 81323, 81405 (x3), 81201, 81203, 81292, 81294, 81317, 81319, 81404 and 81403. . The ICD 10 code(s) associated with the patient’s diagnosis include <<ICD code(s)>>. Hereditary Colorectal Cancer As many as 5% of colorectal cancer diagnoses are thought to be associated with a hereditary predisposition . Hereditary cancers are caused by germline mutations in multiple different genes which significantly increase an individual’s risk to develop cancer. Individuals with mutations in inherited predisposition genes tend to develop cancer at earlier ages, often with bilateral and / or multifocal tumors, which can also occur in less frequently affected genders (i.e.: male breast cancer). Families with hereditary cancer syndromes generally have several family members affected with cancer across multiple generations. Although individual mutated genes can be associated with an increased risk for specific cancers (i.e.: MLH1 and MSH2 with colorectal cancer) there are often multiple additional cancers seen with lower frequency (i.e.: uterine, ovarian, gastric, hepatobiliary, urinary tract, small bowel, sebaceous neoplasms, pancreatic and brain cancer in Lynch Syndrome families). Considering that multiple cancers, including ovarian, pancreatic, melanoma, kidney, breast, uterine, colorectal, sarcoma, brain, leukemia, gastric, thyroid and prostate cancer have been linked with several different cancer predisposition genes, there is significant complexity in choosing a single gene to target for analysis. 1,2 Colorectal Cancer (CRC) inherited diseases include Lynch Syndrome, Hereditary Diffuse Gastric Cancer, Juvenile Polyposis Syndrome, PTEN Hamartoma Syndrome, Familial Adenomatous Polyposis, PeutzJeghers Syndrome, Li-Fraumeni Syndrome, CHEK2- related cancers, MUTYH-Associated Polyposis, Ataxia-Telangiectasia, Bloom Syndrome and Mosaic Variegated Aneuploidy Syndrome. Each of these conditions can be associated with multiple cancer diagnoses. This overlap can result in falsely reassuring results when the incorrect target gene is selected. Therefore the assessment of multiple genes associated with a high risk for hereditary colorectal cancers can be useful in determining personal or familial risks . Multigene testing in this setting is likely to alter near-term cancer risk assessment and management recommendations for mutation-affected individuals across a broad spectrum of cancer predisposition genes.” 3 4 Diagnosis of an individual with a hereditary cancer syndrome has significant effects on medical management. Gene specific medical management guidelines demonstrate the clinical utility of hereditary cancer predisposition testing. Many of the cancer syndromes covered in the Colorectal Cancer testing panel have published clinical management guidelines which can help to reduce the risk of morbidity and mortality in patients affected with or at risk for hereditary cancer syndromes. Risk reduction strategies outlined in NCCN management guidelines include surgical interventions (ie: prophylactic colectomy, gastrectomy, mastectomy, hysterectomy and salpingo-oopherectomy); increased surveillance at younger ages (i.e. colonoscopy / sigmoidoscopy, endoscopy, abdominal MRI / CT, mammography/ breast MRI and ultrasound, clinical and self-breast exams, prostate screening) and consideration of chemo preventive pharmaceuticals. 5 Personal History <<Personal Medical History: Include details of patient’s relevant medical history>> Family History <<Family History: Include list of relevant family history information if applicable. Appropriate risk assessment models or limited history should be noted >> Based on published NCCN and ACMG guidelines, the personal and family history of this patient warrants analysis of genes known to be associated with hereditary colorectal cancer The Colorectal Cancer NextGen Sequencing (NGS) and Deletion/Duplication Panel analyzes 17 genes which are associated with a high risk of hereditary colon cancer including, APC, ATM, BLM, BMPR1A, BUB1B, CDH1, CHEK2, EPCAM, MLH1, MSH2, MSH6, MUTYH, PMS2, PTEN, SMAD4, STK11, and TP53. Many hereditary cancer syndromes involving colorectal cancers have overlapping clinical features. Therefore, analysis of a panel of genes known to be associated with colorectal cancers is the most cost-effective and comprehensive testing option. 5,6. The laboratory providing the genetic testing is PreventionGenetics, LLC, (Tax ID: 83 0343803) who is a sponsor of Pediatric Lab Utilization Guidance Services (PLUGS®). PreventionGenetics is committed to providing comprehensive, high quality, and affordable genetic testing that adds value to patient care. Through utilization management strategies at PreventionGenetics, over 1.3 million healthcare dollars are saved annually. I am hopeful that we can work together for <<Mr/Mrs/Ms/Miss patient’s last name’s>> benefit. Please contact me at <<Phone #>> with the result of this prior authorization and/or if you need additional information. Sincerely, <<Name, credentials>> <<Title>> <<Institution>> References: 1. 2. 3. 4. 5. Jasperson, et al. Gastroenterology, 2010. 138(6): 2044-2058 Sameer, et al. Front Oncol, 2013. 3:114 Foulkes. New England Journal of Medicine. 2008; 359: 2143-2153 Desmond et al. JAMA Oncol. 2015;1(7):943-951 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ). Genetic/Familial High-Risk Assessment: Colorectal. Version 2.2015, 10/07/2015. Hedge, et al. Genet Med, 2014. 16(1):101-116 ®