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, State
Re:Patient Name, DOB, ID #
ICD-9 Codes:(quick reference as suggestions: 153.9 malignant neoplasm of the colon, unspecified; V12.72 history colon polyps; 179.9 malignant neoplasm of the uterus, unspecified; 211.3 benign neoplasm of the colon; V16.9 family history of unspecified malignant neoplasm)
This letter is in regards to my patient and your subscriber, First, Last Nameto 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 riskassessment. Mutations in multiplegenes cause hereditary colorectal cancer, which markedly increasethelifetime risk to develop it (such as up to a nearly 100% risk forthose 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 asuterine, 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:
Based on this, I am requesting coverage for this test (ColoNext), whichanalyzes 17 genes associated with hereditary colorectal cancer:APC, BMPR1A, CDH1, CHEK2, EPCAM, GREM1, MLH1, MSH2, MSH6, MUTYH, 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 havepublished 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 estimatemy patient’s risk to develop cancer, and willdirectly 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 onthis test. Management optionsmay include:
- More frequent colonoscopy, starting as early as childhood
- Colectomy
- Upper endoscopy, starting as early as adolescence
- Risk-reducing hysterectomy and/or salpingo-oophorectomy
- Annual urinalysis
- Increased breast screening including self-examinations, clinical breast examinations, mammogram, ultrasound, and MRI
- Breast cancer risk reduction using prophylactic mastectomies and/or chemoprevention
- Annual thyroid ultrasound and exam
- Avoidance of radiation treatment when possible
- Consideration of MRI-based screening/technologies
- Other: ______
Due to the cancerrisks associated with these mutations and interventions available to reduce these risks, this genetic testing is medically indicated.As such, Iam 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-sensitive 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. 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 the 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: 81201x1, 81292x1, 81294x1, 81295x1, 81297x1, 81298x1, 81300x1, 81317x1, 81319x1
Laboratory: Ambry Genetics Corporation (TIN 33-0892453 / NPI 1861568784), a CAP-accredited and CLIA-certified laboratory located at 7 Argonaut, Aliso Viejo, CA 92656
References:
- 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 2.2014, 05/19/2014.
- NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Genetic/Familial High-Risk Assessment: Breast and Ovarian. Version 2.2014, 09/23/2014.