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Insurance Company Name
Address
City, State
Date of claim
Re: Letter of Medical Necessity for Hereditary Breast 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 breast cancer genetic testing (CPT codes: 81211x1, 81213x1, 81228x1,
81321x1, 81323x1, 81408x1) 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 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
As such, First, Last Name personal and/or family history(ies) 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 surveillance for genespecific associated cancers and
 Consideration of specific risk-reduction measures (e.g. prophylactic mastectomy and other
risk-reducing interventions like chemoprevention)
This genetic test detects mutations in 18 genes associated with hereditary breast cancer: BRCA1,
BRCA2, ATM, BARD1, BRIP1, CDH1, CHEK2, MRE11A, MUTYH, NBN, NF1, PALB2, PTEN, RAD50,
RAD51C, RAD51D, STK11 and TP53. These intermediate- and high-penetrance breast cancer
susceptibility genes are associated with risk of between two-to twenty-fold for breast cancer. Most
genes included on the test are also associated with increased risks for other types of cancer.
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 the 18 genes in this test, 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)
 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