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 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 breast cancer predisposition genetic testing (BRCAPlus-CPT codes: 81211x1, 81213x1,
81321x1, 81323x1, 81404x1, 81405x2, 81406x1) 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: 949-900-5501).
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). Inherited breast cancer predisposition is suspected in individuals whose personal
or family histories include any of the following:
 Breast cancer diagnosed at a young age (<50 years of age)
 Multiple primary breast tumors/bilateral tumors
 Male breast cancer
 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
 Patient is of an ethnic group harboring founder mutations in the BRCA1/2 genes. (eg.
Ashkenazi, Dutch, Hungarian, Swedish and Icelandic)
As such, First, Last Name personal and/or family history(ies) of *** are suggestive of inherited
breast 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 surveillance options and age of initial screening for genespecific associated cancers and
 Consideration of specific risk-reduction measures (e.g. prophylactic mastectomy and other
risk-reducing interventions like chemoprevention)
The BRCAPlus panel (genetic test) detects mutations in 6 genes associated with hereditary
breast cancer. Tested genes include: BRCA1, BRCA2, CDH1, PTEN, STK11 and TP53. The BRCAPlus
panel tests high-penetrance breast cancer susceptibility genes associated with risks of up to twentyfold for breast cancer, as well as other cancer types.
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. NGS technology can simultaneously analyze 6 genes included in BRCAPlus, providing
results in a shorter time period and at a fraction of the cost of traditional approaches like Sanger
sequencing.
By ordering BRCAPlus, 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.
SUMMARY OF DIAGNOSIS - ICD-9 CODES (check all that apply) – (use v codes for secondary dx)
 174.9 Malignant neoplasm of  183.0 Malignant neoplasm of the
the breast, unspecified
ovary and other uterine adnex
 179.9 Malignant neoplasm of  233.30 Carcinoma in situ of breast
the uterus, unspecified
 V10.3 History malignancy breast
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