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LETTER OF MEDICAL NECESSITY FOR HEREDITARY BREAST CANCER GENETIC TESTING Date: Date of service/claim To: Utilization Review Department Insurance Company Name, Address, City, State Re: Patient Name, DOB, ID # ICD-9 Codes: (list codes) This letter is to urge you to provide coverage for medically-indicated hereditary breast cancer genetic testing for the above named patient. The personal and/or family history reported on the test requisition form raises significant concern for an inherited predisposition to breast cancer and indicates a reasonable probability of detecting a causative gene mutation. There are many genes known to predispose to breast cancer and the ordered genetic test analyzes 5 high-risk genes, with published medical management guidelines, associated with hereditary breast cancer: BRCA1, BRCA2, CDH1, PTEN, and TP53. These genes substantially increase the risk for breast and other cancers. This multi-gene test is the most efficient and cost-effective way to analyze the implicated breast cancer genes and has significant potential to identify a causative gene mutation in the patient. Identification of a causative gene mutation will clarify the patient’s future cancer risk(s) and target medical management. The rationale for testing is the presence of a mutation in one of these breast cancer genes places this patient at a substantially increased risk for developing cancer and thus would influence our care recommendations significantly. An aggressive approach to reduce the risk of cancer is indicated in individuals who carry a gene mutation that predisposes them to cancer. If a mutation is identified, we would recommend high-risk management to reduce the patient’s risk of developing an advanced stage cancer and subsequently dying of the disease. As such, I am ordering this genetic test as medically necessary care and affirm that the patient has provided informed consent for genetic testing. Please contact me if I can provide you with additional information. Sincerely, Ordering Clinician Name (Signature Provided on Test Requisition Form) Test Details CPT codes: 81211x1, 81213x1, 81321x1, 81323x1 Laboratory: Ambry Genetics Corporation (TIN 33-0892453 / NPI 1861568784), a CAP-accredited and CLIA-certified laboratory located at 15 Argonaut, Aliso Viejo, CA 92656