Insurance Company Name Address City, State Date of claim Re: Letter of Medical Necessity for Hereditary Renal (Kidney) Cancer Genetic 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 hereditary renal cancer genetic testing (CPT codes: 81292x1, 81294x1, 81295x1, 81297x1, 81298x1, 81300x1, 81317x1, 81319x1, 81321x1, 81323x1) 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 renal cancer predisposition is suspected in individuals whose personal or family histories include any of the following: Renal cancer diagnosed at a young age (<45 years-of-age) Multiple primary cancers in one person (eg. two primary renal cancers, renal, thyroid or colon cancer) Two or more family members with renal cancer (on the same side of the family) Three or more family members with renal, thyroid, colon, ovarian or other cancers on the same side of the family Multiple close family members with renal cancer and neuroendocrine tumors (on the same side of the family) As such, First, Last Name personal and/or family history(ies) are suggestive of inherited renal 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 surveillance for gene-specific associated cancers and Consideration of specific risk-reduction measures (e.g. prophylactic surgery and other riskreducing interventions) depending on the genetic alteration identified Genetic testing will be performed through Ambry Genetics Corporation, given its long-standing experience with next-generation sequencing, consistent variant analysis, detailed results reporting and continuous support from highly trained medical directors and genetic counselors. The genetic test detects mutations in 18 genes associated with hereditary renal cancer susceptibility with varying lifetime risks. Tested genes include: EPCAM, FH, FLCN, MET, MITF, MLH1, MSH2, MSH6, PMS2, PTEN, SDHA, SDHB, SDHC, SDHD, TP53, TSC1, TSC2, VHL. NGS technology can simultaneously analyze these 18 genes, providing results in a shorter time period and at a fraction of the cost of traditional approaches like Sanger sequencing. By ordering genetic 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 complete and the laboratory will not bill until testing is concluded. Therefore, we are requesting that the authorization be valid for 6 months. SUMMARY OF DIAGNOSIS - ICD-9 CODES (CHECK ALL THAT APPLY) – (USE V CODES FOR SECONDARY DX) 153.9 Malignant neoplasm of 183.0 the colon, unspecified 157.9 Malignant neoplasm of the ovary V12.72 History colon polyps and other uterine adnex V16.0 Family history of malignancy GI tract Family history of malignancy breast Malignant neoplasm of 189.0 Malignant neoplasm of kidney V16.3 pancreas, unspecified 189.1 Malignant neoplasm of renal pelvis V16.51 Family history of malignancy kidney 174.9 Malignant neoplasm of 189.2 Malignant neoplasm of ureter V16.52 Family history of malignancy bladder the breast, unspecified 189.9 Malignant neoplasm of urinary V18.9 Genetic disease carrier 179.9 Malignant neoplasm of organ, unspecified Others ______________________________ the uterus, unspecified V10.3 History malignancy breast ______________________________ 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