Download Insurance Company Name Address City, State Date of claim Re

Insurance Company Name
Address
City, State
Date of claim
Re: Ambry Genetics Corporation, Letter of Medical Necessity for Hereditary Colorectal Cancer
Predisposition Testing
Patient First, Last Name
DOB
ID Number
Dear Medical Director,
This letter is in regards to my patient and your subscriber, First, Last Name to request full
coverage for colorectal cancer predisposition genetic testing (ColoNext) to be performed by Ambry
Genetics Corporation (TIN 33-0892453 / NPI 1861568784), a CAP approved and CLIA certified
laboratory located at 15 Argonaut, Aliso Viejo, CA 92656.
The American Society of Clinical Oncology (ASCO) recommends that genetic testing be offered
to individuals with suspected inherited (genetic) cancer risk in situations where test results can be
interpreted, and when they can affect medical management of the patient (J Clin Oncol. 2003 Jun 15;
21(12):2397-406). Inherited colorectal cancer predisposition is suspected in individuals whose
personal or family histories include any of the following:
 Colorectal cancer diagnosed at a young age (<50 years-of-age)
 Colorectal cancer clustered with ovarian, uterine or other cancers
 Rare tumor types
 Non-malignant findings known to be associated with cancer syndromes
 Cancer diagnosed in multiple generations and/or multiple people within the same
generation
As such, First, Last Name personal and/or family history(ies) are suggestive of inherited
colorectal cancer susceptibility. Based on my evaluation and review of the available literature,
molecular testing is crucial in order to establish/confirm a genetic syndrome diagnosis and in
guiding appropriate and immediate medical management. A positive genetic test result can
provide the following benefits to this patient:
 Appropriate surgical management and other treatment guidance
 Modification of cancer surveillance options and age of initial screening for gene-specific
associated cancers and
 Consideration of specific risk-reduction measures (e.g. prophylactic surgery and other riskreducing interventions) depending on the genetic alteration identified.
Genetic testing will be performed through Ambry Genetics Corporation, given its long-standing
experience with next-generation sequencing, consistent variant analysis, detailed results reporting
and continuous support from highly trained medical directors and genetic counselors.
The ColoNext panel (genetic test) detects mutations in 14 genes associated with hereditary
colorectal cancer susceptibility with varying lifetime risks. Tested genes include: APC, BMPR1A,
CDH1, CHEK2, EPCAM, MLH1, MSH2, MSH6, MUTYH, PMS2, PTEN, SMAD4, STK11 and TP53.
NGS technology can simultaneously analyze 14 genes in the ColoNext panel, providing results in a
shorter time period and at a fraction of the cost of traditional approaches like Sanger sequencing.
By ordering ColoNext, I, the authorized clinician/medical professional acknowledge that the
patient has been supplied with information regarding genetic testing and the patient has given
informed consent for genetic testing to be performed and the signed consent form is on file. I
confirm that the ordered testing is medically necessary for the diagnosis or detection of a
predisposition to and/or current disease, illness, impairment, syndrome or disorder, and that these
results will be used in the medical management and treatment decisions for this patient.
I recommend that you support this request for coverage of diagnostic genetic testing for hereditary
cancer predisposition for my patient. Genetic testing can take up to four months to complete and
the laboratory will not bill until testing is concluded. Therefore, we are requesting that the
authorization be valid for 6 months.
SUMMARY OF DIAGNOSIS - ICD-9 CODES (check all that apply) – (use v codes for secondary dx)
 151.9 Malignant neoplasm of  183.0
the stomach, unsp.
 153.9 Malignant neoplasm of
the colon, unspecified
 179.9 Malignant neoplasm of
the uterus, unspecified
Malignant neoplasm of the
ovary and other uterine adnex
 211.3
Benign neoplasm of the colon
 V10.05 History malignancy large
intestine
 V12.72 History colon polyps
 V16.0
Family history of malignancy
GI tract
 V16.41 Family history malignancy ovary
 V18.9 Genetic disease carrier
 Others ______________________________
______________________________
Thank you for your time and please don’t hesitate to contact me with any questions.
Sincerely,
Ordering Clinician Signature ________________________________ Date ______________
(MD/DO, Clinical Nurse Specialist, Nurse-Midwives, Nurse Practitioner, Physician Assistant,
Genetic Counselor*)
*Authorized clinician requirements vary by state