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 Breast and Ovarian
Cancer Predisposition Testing
Patient First, Last Name
DOB
ID Number
Dear Medical Director,
This letter is in regard to my patient and your subscriber, First, Last Name to request full
coverage for breast and ovarian cancer predisposition genetic testing BRCA1 and BRCA2 (BRCA1/2)
gene sequence and deletion/duplication analyses (CPT codes: 81211x1, 81213x1) 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 (phone: 949-900-5500, fax: 949900-5501).
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). The National Comprehensive Cancer Network provides guidelines for genetic
testing (NCCN Version 3.2013 Hereditary Breast and/or Ovarian Cancer Syndrome). My patient
meets NCCN guidelines for genetic testing based on the following (remove all that do not apply):
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Breast cancer diagnosed at a young age (<45 years of age)
Breast cancer diagnosed at 50 years of age or younger with a family history of breast cancer
History of “triple negative” breast cancer
Breast cancer diagnosed at any age with a family history of breast cancer in at least one close
relative at age 50 years or younger
Breast cancer with two or more close relatives diagnosed with breast cancer at any age
History of epithelial ovarian cancer at any age
Breast cancer diagnosis with a family history of ovarian cancer diagnosed at any age
Breast cancer diagnosis with a relative diagnosed with male breast cancer
Male breast cancer
Pancreatic cancer or aggressive prostate cancer in the setting of a family history of breast
and/or ovarian cancer
A family history of cancer that meets any one or more of the above criteria
Patient is of an ethnic group harboring founder mutations in the BRCA1/2 genes. (eg.
Ashkenazi, Dutch, Hungarian, Swedish and Icelandic)
Other history_____________________________________________________________________
As such, the personal and/or family history of First, Last Name is 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 breast cancer and ovarian cancer surveillance options and age of initial
screening for BRCA1/2 associated cancers and
 Consideration of specific risk-reduction measures (e.g. prophylactic oophorectomy and/or
mastectomy and other risk-reducing interventions such as chemoprevention)
Genetic testing will be performed through Ambry Genetics Corporation, given its longstanding experience with next-generation sequencing (NGS), consistent variant analysis, detailed
results reporting and continuous support from highly trained medical directors and genetic
counselors.
By ordering BRCA1/2 Gene Sequence and Deletion/Duplication Analyses, 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.
SUMMARY OF DIAGNOSIS - ICD-9 CODES (check all that apply) – (use v codes for secondary dx)
 174.9 Malignant neoplasm of  183.0
the breast, unspecified
Malignant neoplasm of the
ovary and other uterine adnexa
 157.9 Malignant neoplasm of  233.30 Carcinoma in situ of breast
 185
 V16.3 Family history malignant neoplasm
breast
 V16.41 Family history malignancy ovary
pancreas
 V10.3 History malignancy breast
 V18.9 Genetic disease carrier
Malignant neoplasm of
 V10.43 Personal history of malignant
 Others ______________________________
prostate
neoplasm of ovary
______________________________
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