Genetic Testing for Hereditary Cancer | Ambry Genetics



LETTER OF MEDICAL NECESSITY FOR HEREDITARY BREAST/GYNECOLOGIC CANCER GENETIC TESTING (BRCANext)Date: Date of service/claim To:Utilization Review Department Insurance Company Name, Address, City, StateRe:Patient Name, DOB, ID #ICD-10 Codes: (quick reference as suggestions: C55 malignant neoplasm of uterus, part unspecified; C56.9 malignant neoplasm of unspecified ovary; C18.9 malignant neoplasm of colon, unspecified; C50.919 malignant neoplasm of unspecified site of unspecified female breast;? Z80.9 family history of malignant neoplasm, unspecified; C25.9 malignant neoplasm of pancreas, unspecified; Personal history: Z85.3 breast cancer; Family history: Z80.3 breast cancer; Z83.71 colon cancer) 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/gynecologic cancer to be performed by Ambry Genetics Corporation.Breast and gynecologic cancers (e.g. ovarian and uterine) are thought to have a hereditary component in up to 10% and 25% of cases respectively. Evaluating personal and family histories is a major part of hereditary cancer risk assessment. In high-risk women with a positive BRCA1/BRCA2 test result, the cumulative risk estimate is up to 87% for developing breast cancer.1 The risk for ovarian cancer for BRCA1/BRCA2 mutation carriers has been estimated at up to 40% for those with a family history.1 The cancer risk in individuals with Lynch syndrome with a positive mutation in MLH1 or MSH2 is as high as 60% for uterine cancer.2Significant aspects of my patient’s personal and/or family medical history that suggest a reasonable probability of hereditary breast/gynecologic cancer are below:Ovarian, male breast, pancreatic, or metastatic prostate cancer at any ageEarly-onset breast cancer (diagnosed before 45), triple negative breast cancer (diagnosed before 60) or uterine cancer (diagnosed before 50)Multiple primary cancers in one person (e.g. uterine and breast or thyroid cancer)Multiple close family members with ovarian or uterine and other cancers (on the same side of the family)Cancer histories that are suspicious for both hereditary breast and ovarian cancer and Lynch syndromeA known mutation in a cancer susceptibility gene within the familyBased on this, I am requesting coverage for this test (BRCANext), which analyzes 18 genes associated with hereditary breast/gynecologic cancer: ATM, BRCA1, BRCA2, BRIP1, CDH1, CHEK2, EPCAM, MLH1, MSH2, MSH6, NBN, NF1, PALB2, PMS2, PTEN, RAD51C, RAD51D, TP53. According to published guidelines, more than one gene may explain an inherited cancer syndrome, thus multi-gene testing may be more efficient and/or cost-effective.2-4Based on the above personal and/or family history, my patient is suspicious for ______________________ syndrome(s). As clinical features of many hereditary cancer syndromes overlap and there is a reasonable probability of detecting a mutation in my patient, this multi-gene test is the most efficient, cost-effective way to analyze the multiple genes associated with hereditary cancer conditions.3 According to published guidelines, germline genetic testing is warranted.2,3 This genetic testing will help estimate my patient’s risk to develop cancer/another primary cancer and directly impact my patient’s medical management. All the genes in this test have published clinical practice guidelines to reduce the risk for cancer and/or detect cancer early, to reduce morbidity and mortality. Management options may include2,3 [check all that apply]:Gynecologic cancer risk reduction using risk-reducing salpingo-oophorectomy and/or hysterectomyMore frequent colonoscopyIncreased breast screening including self-examinations, clinical breast examinations, mammogram, ultrasound, MRIBreast cancer risk reduction using prophylactic mastectomies Prostate cancer screening (PSA and DRE)5,6Avoidance of radiation treatment when possible Consideration of other MRI-based screening/technologies7Other:____________________________________________________________Several studies have indicated that genetic testing results significantly influence treatment choices.8-10 For example, the 2014 systematic review by the U.S. Preventive Services Task Force determined the efficacy of risk-reducing surgery in BRCA1/2 mutation-positive women. For high-risk women and mutation carriers, bilateral mastectomy reduced breast cancer incidence by 85-100% and breast cancer mortality by 81% and 100%, respectively; salpingo-oophorectomy reduced breast cancer incidence by 37-100%, ovarian cancer incidence by 69-100%, and all-cause mortality by 55-100%, respectively.11Due to the cancer risks associated with these mutations and interventions available to reduce these risks, this genetic testing is medically indicated. As such, I am ordering this testing as medically necessary 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 which provides highly-sensitive12 and cost-effective testing for hereditary breast/gynecologic cancer, along with a large database of previously 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 hereditary breast/gynecologic cancer in my patient. 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 DetailsCPT codes: 81162, and 81292, 81294, 81295, 81297, 81298, 81300, 81317, 81319, or 81479Laboratory: Ambry Genetics Corporation (TIN 33-0892453 / NPI 1861568784), a CAP-accredited and CLIA-certified laboratory located at 7 Argonaut, Aliso Viejo, CA 92656References:Chen S and Parmigiani G. Meta-analysis of BRCA1 and BRCA2 penetrance. J Clin Oncol. 2007 Apr 10;24(1):1329-33.NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines?). Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic. Version 1.2020, 12/04/2019. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines?). Genetic/Familial High-Risk Assessment: Colorectal. Version 3.2019, 12/13/2019. Lancaster JM, et al. Society of Gynecologic Oncology statement on risk assessment for inherited gynecologic cancer predispositions. Gynecol Oncol. 2015 Jan;136(1):3-7.Kirchhoff T, et al. BRCA mutations and risk of prostate cancer in Ashkenazi Jews. Clin Cancer Res. 2004 May;10(9):2918-2921. Castro E, et al. Germline BRCA mutations are associated with higher risk of nodal involvement, distant metastasis, and poor survival outcomes in prostate cancer. J Clin Oncol. 2013 May;31(14):1748-1757. Villani A, et al. Biochemical and imaging surveillance in germline TP53 mutation carriers with Li-Fraumeni syndrome: a prospective observational study. Lancet Oncol. 2011 Jun;12(6):559-67. Menkiszak J, et al. Attitudes toward preventive oophorectomy among BRCA1 mutation carriers in Poland. Eur J Gynaecol Oncol. 2004;25(1):93-95. Scheuer L, et al. Outcome of preventive surgery and screening for breast and ovarian cancer in BRCA mutation carriers. J Clin Oncol. 2002 Mar;20(5):1260-1268. Weitzel JN, et al. Effect of genetic cancer risk assessment on surgical decisions at breast cancer diagnosis. Arch Surg. 2003 Dec;138(12):1323-1328; discussion 1329. Nelson HD, et al. Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer: Systematic Review to Update the U.S. Preventive Services Task Force Recommendation. Evidence Synthesis No. 101 (AHRQ Publication No. 12-05164-EF-1). Rockville, MD Agency for Healthcare Research and Quality; 2013.Mu W, et al. Sanger confirmation is required to achieve optimal sensitivity and specificity in next-generation sequencing panel testing. J Mol Design. 2016 Nov;18(6):923-932. ................
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