Letter of Medical Necessity Test Code 1949 / 1947 <<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 Breast and Ovarian Cancer Syndrome genetic sequencing of genes BRCA1 and BRCA2. Billing is through <<billing institution>> with testing performed at PreventionGenetics, LLC. CPT codes for PreventionGenetics test code #1949 include: 81211 and 81213. {CPT codes for PreventionGenetics test code 1947, NGS sequencing only is 81211} The ICD 10 code(s) associated with the patient’s diagnosis include <<ICD code(s)>>. Hereditary Breast and Ovarian Cancer Syndrome As many as 10% of cancer diagnoses are thought to be associated with a hereditary predisposition . Although hereditary cancers are caused by germline mutations in multiple different genes which significantly increase an individual’s risk to develop cancer. The majority of Hereditary Breast and Ovarian Cancer Syndrome (HBOC) cases are attributed to pathogenic variants (mutations) in the BRCA1 and/or BRCA2 genes. Individuals with mutations in inherited predisposition genes, including BRCA1 and BRCA2 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. BRCA1 and BRCA2 with breast and ovarian cancers) there are often multiple additional cancers seen with lower frequency (i.e. prostate, male breast, melanoma, pancreatic, gallbladder, bile duct and gastric cancer in BRCA1 and BRCA2 families) 1 2 Diagnosis of an individual with HBOC has significant effects on medical management. Gene specific medical management guidelines demonstrate the clinical utility of hereditary cancer predisposition testing. Implementation of published clinical management guidelines for HBOC can help to reduce the risk of morbidity and mortality in affected patients. Risk reduction strategies outlined in NCCN management guidelines include surgical interventions (ie: prophylactic mastectomy and salpingo-oopherectomy), increased surveillance (i.e. mammography, clinical and self-breast exams, MRI, ultrasound, colonoscopy, endoscopy, prostate screening) and consideration of chemo preventive pharmaceuticals. 3,4 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 >> <<Mr./Ms./Mrs./Miss patient last name>> meets the National Comprehensive Cancer Network (NCCN) guidelines for BRCA1 and BRCA2 genetic testing due to his <<personal/family history>> of breast and/or ovarian cancer. Based on published NCCN guidelines, the personal and family history of this patient warrants HBOC analysis. . ** Testing of the BRCA1 and BRCA2 genes through the HBOC NextGen Sequencing Panel, with reflex (test code #1949) will reflex to the BRCA1 and BRCA2 Deletion/Duplication panel in the event a pathogenic variant is not identified via NGS and will allow for delineation of appropriate screening and management guidelines for this patient and his/her family members. **{Testing of the BRCA1 and BRCA2 genes through the HBOC NextGen Sequencing Panel (test code #1947) will sequence via NGS, without reflexing to the deletion / duplication panel,} 5 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. Mauer et al. Genetics in Medicine. 2013 Petrucelli et al. GeneReviews. 2011 Domcheck et al. JAMA. 2010;304 (9): 697-975 Finch et al. J Clin Oncol. 2014;32(15):1547-1553 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ). Genetic/Familial High-Risk Assessment: Breast and Ovarian. Version 2.2015, 06/25/2015. ®