Genetic Testing for Hereditary Cancer | Ambry Genetics



LETTER OF MEDICAL NECESSITY FOR HEREDITARY COLORECTAL CANCER GENETIC TESTING (ColoNext)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: : C18.9 malignant neoplasm of colon, unspecified; Z86.010 personal history colon polyps; C55 malignant neoplasm of uterus, part unspecified; D12.6 benign neoplasm of colon, unspecified; Z80.9 family history of malignant neoplasm, unspecified) 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 colorectal cancer to be performed by Ambry Genetics Corporation. Colorectal cancer is thought to have a hereditary component in up to 10% of cases; evaluating personal and family histories is a major part of this risk assessment. Mutations in multiple genes cause hereditary colorectal cancer, which markedly increase the lifetime risk to develop it (such as up to a nearly 100% risk for those with APC mutations and up to 80% risk for MLH1 and MSH2 mutations). Some of these gene mutations also increase the lifetime risk for other cancers (such as uterine, small bowel, breast, ovarian, sarcomas, brain, gastric, thyroid, renal, and prostate). Significant aspects of my patient’s personal and/or family medical history that suggest a reasonable probability of hereditary colorectal cancer are below:Early-onset colorectal cancer (diagnosed <50 years of age)Multiple primary cancers in one person (e.g. two primary colorectal cancers or colorectal and uterine cancer)3 or more family members with colorectal, uterine, ovarian, and/or stomach cancer*Multiple close family members, on the same side of the family, with colorectal and other cancers10 or more GI polyps during one’s lifetime (adenomatous, hyperplastic, hamartomatous, and/or other types of polyps)Previous genetic testing for hereditary colorectal cancer was uninformative (negative or VUS)Based on this, I am requesting coverage for this test (ColoNext), which analyzes 20 genes associated with hereditary colorectal cancer: APC, AXIN2, BMPR1A, CDH1, CHEK2, EPCAM, GREM1, MLH1, MSH2, MSH3, MSH6, MUTYH, NTHL1, PMS2, POLD1, POLE, PTEN, SMAD4, STK11, TP53. Due to the significant clinical overlap associated with mutations in the above-mentioned genes, this multi-gene test is the most efficient and cost-effective way to analyze these genes.1,2 Many of the genes in this test have published clinical practice guidelines to reduce cancer risk and/or detect cancer early, to reduce morbidity and mortality. According to published guidelines, germline genetic testing is warranted.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. Management options may include: More frequent colonoscopy, starting as early as childhood ColectomyUpper endoscopy, starting as early as adolescenceRisk-reducing hysterectomy and/or bilateral salpingo-oophorectomyAnnual urinalysisIncreased breast screening including self-examinations, clinical breast examinations, mammogram, ultrasound, and MRIBreast cancer risk reduction using prophylactic mastectomies and/or chemopreventionAnnual thyroid ultrasound and examAvoidance of radiation treatment when possible Consideration of MRI-based screening/technologiesOther: ____________________________________Due 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 because this laboratory has highly-sensitive5 and cost-effective testing for hereditary colorectal 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 colorectal 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: 81201, 81292, 81294, 81295, 81297, 81298, 81300, 81317, 81319, or 81435, 81436, 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:Meldrum C, Doyle MA, Tothill RW. Next-generation sequencing for cancer diagnostics: a practical perspective. Clin Biochem Rev. 2011 Nov;32(4):177-95.Cragun D, et al. Panel-based testing for inherited colorectal cancer: a descriptive study of clinical testing performed by a US laboratory. Clin Genet. Dec;86(6):510-20. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines?). Genetic/Familial High-Risk Assessment: Colorectal. Version 3.2019, 12/13/2019. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines?). Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic. Version 1.2020, 12/04/2019. 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. ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download