LETTER OF MEDICAL NECESSITY FOR HEREDITARY BREAST CANCER GENETIC TESTING (BRCA1/BRCA2 Sequence and Deletion/Duplication) Date: Date of service/claim To: Utilization Review Department Insurance Company Name, Address, City, State Re: Patient Name, DOB, ID # ICD-9 Codes: (quick reference as suggestions: 174.9 malignant neoplasm of female breast, unspecified; 233.0 carcinoma in situ of breast; V10.3 personal history of breast cancer; V16.3 family history of breast cancer; V16.9 family history of unspecified malignant neoplasm) This letter is in regards to my patient and your subscriber, First, Last Name to request full coverage of medically-indicated genetic testing for hereditary breast and ovarian cancer (HBOC) to be performed by Ambry Genetics Corporation. Breast and ovarian cancers are thought to have a hereditary component in up to 10% and up to 25% of cases, respectively; evaluating personal and family histories is a major part of hereditary cancer risk assessment. Mutations in multiple genes cause HBOC, but mutations in BRCA1/BRCA2 are the most common. Women that carry a BRCA1 or BRCA2 mutation have up to an 87% lifetime risk to develop breast cancer (compared to 12% in the general population), a 40-60% lifetime risk for a second primary breast cancer, and a 11-40% lifetime risk to develop ovarian cancer (compared to 1.6% in the general population.)1 Men that carry a BRCA1 or BRCA2 mutation have an elevated risk for breast and prostate cancer.1 Significant aspects of my patient’s personal and/or family medical history that suggest a reasonable probability of HBOC are below: Based on my patient’s personal and/or family history above, he/she meets the American Society of Clinical Oncologists (ASCO) and/or National Comprehensive Cancer Network (NCCN) published guidelines for BRCA1/2 testing. 2,3,4 This genetic testing will help estimate my patient’s risk to develop cancer, and will directly impact my patient’s medical management. If a mutation is identified, we will adjust medical care to reduce my patient’s risk of developing (and potentially dying of) an advanced stage cancer. An aggressive approach following established screening and management guidelines is indicated in individuals that carry a mutation found on this test. Guidelines suggest the following screening options: For breast cancer: breast self-examinations, clinical breast examinations, mammogram, ultrasound, MRI, consideration of prophylactic mastectomies, and/or chemoprevention to reduce a woman’s risk of developing breast cancer. For ovarian cancer: risk-reducing salpingo-oophorectomy For prostate cancer: PSA and digital rectal exam (DRE) This test includes full-gene sequencing and deletion/duplication analysis of BRCA1 and BRCA2. Due to the cancer risks associated with these mutations and the interventions available to reduce these risks, I am requesting coverage for this testing as medically necessary care and affirm that my patient has provided informed consent for genetic testing. A positive test result would confirm a genetic diagnosis and/or risk in my patient, and would ensure my patient is being managed appropriately. I am specifying Ambry Genetics Corporation because this laboratory has highly-sensitive and cost-effective testing for hereditary breast cancer, along with a large database of tested patients to ensure highly validated, accurate, and informative test interpretation. I recommend that you support this request for coverage of diagnostic genetic testing for HBOC in my patient. Genetic testing can take up to several weeks to complete and the laboratory will not bill until testing is concluded. Therefore, we are requesting that authorization be valid for 3 months. Thank you for your time and please don’t hesitate to contact me with any questions. Sincerely, Ordering Clinician Name (Signature Provided on Test Requisition Form) (MD/DO, Clinical Nurse Specialist, Nurse-Midwives, Nurse Practitioner, Physician Assistant, Genetic Counselor*) *Authorized clinician requirements vary by state Test Details CPT codes: 81211x1, 81213x1 Laboratory: Ambry Genetics Corporation (TIN 33-0892453 / NPI 1861568784), a CAPaccredited and CLIA-certified laboratory located at 15 Argonaut, Aliso Viejo, CA 92656 References: 1. Chen S and Parmigiani G. 2007. Meta-analysis of BRCA1 and BRCA2 penetrance. J Clin Oncol. 2007 25(11):1329-1333. 2. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Genetic/Familial HighRisk Assessment: Breast and Ovarian. Version 2.2014, 09/23/2014. 3. American Society of Clinical Oncology. American Society of Clinical Oncology policy statement update: genetic testing for cancer susceptibility. J Clin Oncol. 2003 Jun 15:21(12):2397-406. 4. Robson ME, et al. American Society of Clinical Oncology policy statement: Genetic and genomic testing for cancer susceptibility. J Clin Oncol. 2010 Feb 10;28(5):893-901.