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Insurance Company Name
Address
City, State
Date of claim
Re: Letter of Medical Necessity for Hereditary Cancer Genetic 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 hereditary cancer genetic testing (CPT codes: 81201x1, 81211x1, 81213x1, 81292x1,
81294x1, 81295x1, 81297x1, 81298x1, 81300x1, 81317x1, 81319x1) 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 cancer predisposition is suspected in individuals whose personal or
family histories include any of the following:
 Cancer diagnosed at a young age
 Multiple primary tumors/bilateral tumors
 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 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 surveillance 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
The genetic test detects mutations in 28 genes associated with hereditary breast, colon,
ovarian, uterine and other cancer susceptibility with varying lifetime risks. Tested genes include:
APC, ATM, BARD1, BRCA1, BRCA2, BRIP1, BMPR1A, CDH1, CDK4, CDKN2A, CHEK2, EPCAM,
MLH1, MRE11A, MSH2, MSH6, MUTYH, NBN, NF1, PALB2, PMS2, PTEN, RAD50, RAD51C,
RAD51D, SMAD4, STK11, and TP53. Genetic testing will be performed through Ambry Genetics
Corporation, given its long-standing experience with next-generation sequencing (NGS), consistent
variant analysis, detailed results reporting and continuous support from highly trained medical
directors and genetic counselors. NGS technology can simultaneously analyze 28 genes, providing
results in a shorter time period and at a fraction of the cost of traditional approaches like Sanger
sequencing.
By ordering this genetic test, 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
 174.9 Malignant neoplasm of
the breast, unspecified
 179.9 Malignant neoplasm of
the uterus, unspecified
 211.3
Malignant neoplasm of the
 V12.72 History colon polyps
ovary and other uterine adnex
 V16.0
Benign neoplasm of the colon
Family history of malignancy
GI tract
 233.30 Carcinoma in situ of breast
 V16.3
 V10.05 History malignancy large
 V16.41 Family history malignancy ovary
intestine
 V10.3 History malignancy breast
Family history of malignancy breast
 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