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Insurance Company Name Address City, State Date of claim Re: Ambry Genetics Corporation, Letter of Medical Necessity for Hereditary Cancer Predisposition Testing Patient First, Last Name DOB ID Number Dear Medical Director, This letter is in regards to my patient and your subscriber, First, Last Name to request full coverage for cancer predisposition genetic testing to be performed by Ambry Genetics Corporation (TIN 33-0892453 / NPI 1861568784), a CAP approved and CLIA certified laboratory located at 15 Argonaut, Aliso Viejo, CA 92656. The American Society of Clinical Oncology (ASCO) recommends that genetic testing be offered to individuals with suspected inherited (genetic) cancer risk in situations where test results can be interpreted, and when they can affect medical management of the patient (J Clin Oncol. 2003 Jun 15; 21(12):2397-406). Inherited cancer predisposition is suspected in individuals whose personal or family histories include any of the following: Cancer diagnosed at a young age Multiple primary tumors/bilateral tumors Rare tumor types Non-malignant findings known to be associated with cancer syndromes Cancer diagnosed in multiple generations and/or multiple people within the same generation As such, First, Last Name personal and/or family history(ies) are suggestive of inherited cancer susceptibility. Based on my evaluation and review of the available literature, molecular testing is crucial in order to establish/confirm a genetic syndrome diagnosis and in guiding appropriate and immediate medical management. A positive genetic test result can provide the following benefits to this patient: Appropriate surgical management and other treatment guidance Modification of cancer surveillance options and age of initial screening for gene-specific associated cancers and Consideration of specific risk-reduction measures (e.g. prophylactic surgery and other risk-reducing interventions) depending on the genetic alteration identified Genetic testing will be performed through Ambry Genetics Corporation, given its longstanding experience with next-generation sequencing, consistent variant analysis, detailed results reporting and continuous support from highly trained medical directors and genetic counselors. By ordering testing, I, the authorized clinician/medical professional acknowledge that the patient has been supplied with information regarding genetic testing and the patient has given informed consent for genetic testing to be performed and the signed consent form is on file. I confirm that the ordered testing is medically necessary for the diagnosis or detection of a predisposition to and/or current disease, illness, impairment, syndrome or disorder, and that these results will be used in the medical management and treatment decisions for this patient. I recommend that you support this request for coverage of diagnostic genetic testing for hereditary cancer predisposition for my patient. Genetic testing can take up to four months to SUMMARY OF DIAGNOSIS - ICD-9 CODES (check all that apply) – (use v codes for secondary dx) 151.90 Malignant neoplasm of the stomach, unspecified 153.90 Malignant neoplasm of the colon, unspecified 174.90 Malignant neoplasm of the breast, unspecified 179.90 Malignant neoplasm of 183.00 Malignant neoplasm of the ovary and other uterine adnex 211.30 Benign neoplasm of the colon V12.72 History colon polyps V16.00 Family history of malignancy GI tract 233.30 Carcinoma in situ of breast V16.30 Family history of malignancy breast V10.05 History malignancy large V16.41 Family history malignancy ovary intestine V10.30 History malignancy breast the uterus, unspecified V18.90 Genetic disease carrier Others ______________________________ ______________________________ complete and the laboratory will not bill until testing is concluded. Therefore, we are requesting that the authorization be valid for 6 months. Thank you for your time and please don’t hesitate to contact me with any questions. Sincerely, Ordering Clinician Signature ________________________________ Date ______________ (MD/DO, Clinical Nurse Specialist, Nurse-Midwives, Nurse Practitioner, Physician Assistant, Genetic Counselor*) *Authorized clinician requirements vary by state