LETTER OF MEDICAL NECESSITY FOR HEREDITARY COLORECTAL CANCER GENETIC TESTING (LYNCH
SYNDROME)
Date:
To:
Re:
Date of service/claim
Utilization Review Department
Insurance Company Name, Address, City, State
Patient Name, DOB, ID #
ICD-9 Codes: (quick reference as suggestions: 153.9 malignant neoplasm of the colon, unspecified;
179.9 malignant neoplasm of the uterus, unspecified; 183.0 malignant neoplasm of the ovary and other uterine adnex; 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 Lynch syndrome to be performed by Ambry Genetics
Corporation.
Lynch syndrome (LS), formerly known as hereditary non-polyposis colorectal cancer (HNPCC), is the most common cause of hereditary colorectal cancer. It causes 3-4% of all colorectal cancers and
1-2% of all uterine cancers diagnosed in the U.S. each year. LS is caused by mutations in mismatch repair genes (MSH2, MSH6, MLH1, PMS2) and EPCAM. Individuals with LS have an increased lifetime risk for several different types of cancer, including up to an 82% risk to develop colorectal cancer
(compared to 5.5% in the general population) and up to a 50% risk to develop a second colorectal cancer.
1 Women with LS also have up to a 60% risk for uterine cancer (compared to 2.7% in the general population).
1 Other cancers, including gastric, ovarian, hepatobiliary, urinary tract, small bowel, and central nervous system tumors may also occur more often in these individuals.
1
Significant aspects of my patient’s personal and/or family medical history that suggest a reasonable probability of Lynch syndrome are below:



Based on this I am requesting coverage for this genetic testing, which includes comprehensive analysis of 5 genes associated with LS: MLH1, MSH2, EPCAM, MSH6, PMS2. This multi-gene test is the most efficient, cost-effective way to analyze the multiple genes associated with LS. Based on the personal and/or family history, my patient meets the National Comprehensive Cancer
Network (NCCN) guidelines for Lynch syndrome genetic testing.
2
This Lynch syndrome genetic testing will help estimate my patient’s risk to develop cancer.
It will also 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:
 Colonoscopy performed every 1-2 years, starting as early as 20 years of age
 More aggressive colorectal cancer surgery
 Risk-reducing hysterectomy with salpingo-oophorectomy

 Annual urinalysis
 Other:__________________________________
Due to the cancer risks associated with these mutations and the interventions available to reduce these risks, Lynch syndrome 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 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: 81292x1, 81295x1, 81298x1, 81294x1, 81297x1, 81300x1, 81403x1, 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.
Aarnio M, et al. Cancer risk in mutation carriers of DNA-mismatch-repair genes. Int J Cancer. 1999
Apr 12;81(2):214-8.
2.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ). Genetic/Familial High-Risk
Assessment: Colorectal. Version 2.2014, 05/19/2014.