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 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:
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Based on this, I am requesting coverage for this test (ColoNext), which analyzes 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 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:
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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
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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 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-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 CAPaccredited and CLIA-certified laboratory located at 15 Argonaut, Aliso Viejo, CA
92656
References:
1.
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3.
4.
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.