LETTER OF MEDICAL NECESSITY FOR HEREDITARY CANCER GENETIC TESTING (CancerNext)
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 suggestions – Active diagnosis: 174.9 female breast cancer,
unspecified; 153.9 colon cancer, unspecified; Personal history: V10.3 breast cancer; Family history:
V16.3 breast cancer; V16.0 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 cancer to be performed by Ambry Genetics
Corporation.
Cancer is thought to have a hereditary component in up to 10% of cases; evaluating personal and
family histories is a major part of hereditary cancer risk assessment. Mutations in multiple genes
cause hereditary cancer, which markedly increase the lifetime risk for many types of cancer (such
as up to 87% risk for breast cancer for women with BRCA1 and BRCA2 mutations). Some of these
gene mutations also increase the lifetime risk for other cancers (such as ovarian, uterine, colorectal,
sarcomas, brain, leukemia, gastric, thyroid, and prostate).
Significant aspects of my patient’s personal and/or family medical history that suggest a
reasonable probability of hereditary cancer are below:
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Based on this, I am requesting coverage for this test (CancerNext). CancerNext includes
comprehensive analysis of 32 genes associated with hereditary cancer: APC, ATM, BARD1, BRCA1,
BRCA2, BRIP1, BMPR1A, CDH1, CDK4, CDKN2A, CHEK2, EPCAM, GREM1, MLH1, MRE11A, MSH2,
MSH6, MUTYH, NBN, NF1, PALB2, PMS2, POLD1, POLE, PTEN, RAD50, RAD51C, RAD51D, SMAD4,
SMARCA4, STK11, TP53. Based on the above personal and/or family history, my patient is
suspicious for ______________________________ syndrome(s) [quick suggestions: hereditary breast
ovarian cancer, Lynch syndrome, Cowden syndrome, Li-Fraumeni syndrome, etc.]. As clinical
features of many of these conditions 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.1,2
This genetic testing will help estimate my patient’s risk to develop (and potentially die of)
cancer. It will also directly impact my patient’s medical management. Many of 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 include:
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Increased breast screening including self-examinations, clinical breast
examinations, mammogram, ultrasound, and MRI
Breast cancer risk reduction using prophylactic mastectomies and/or
chemoprevention
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Risk-reducing salpingo-oophorectomy
Prostate cancer screening (PSA and DRE)
Annual thyroid ultrasound and exam
More frequent colonoscopy
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 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
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, 81211x1, 81213x1, 81292x1, 81294x1, 81295x1, 81297x1, 81298x1,
81300x1, 81317x1, 81319x1, 81321x1
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.
2.
3.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Genetic/Familial High-Risk Assessment:
Breast and Ovarian. Version 2.2014, 09/23/2014.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Genetic/Familial High-Risk Assessment:
Colorectal. Version 2.2014, 05/19/2014.
Meldrum C, Doyle MA, Tothill RW. Next-generation sequencing for cancer diagnostics: a practical perspective.
Clin Biochem Rev. 2011 Nov;32(4):177-95.