LETTER OF MEDICAL NECESSITY FOR HEREDITARY CANCER GENETIC TESTING (CancerNext-Expanded)

Date: Date of service/claim

To: Utilization Review Department

Insurance Company Name, Address, City, State

Re: Patient Name, DOB, ID #:

ICD-9 Codes: (quick reference suggestions – Active diagnosis: 174.9 female breast cancer, unspecified;153.9 colon cancer, unspecified; 157.9 pancreas cancer, unspecified; 189.0 kidney cancer except pelvis; 194.6 aortic body and other paraganglia cancer; 227.6 benign neoplasm of aortic body and other paraganglia; Personal history: V10.3 breast cancer; Family history: V16.3 breast cancer; V16.0 colon cancer)

This letter is in regards to my patient and your subscriber, First, Last Name to request full coverage of medically-indicated genetic testing for hereditary cancer to be performed by Ambry Genetics Corporation.

Cancer is thought to have a hereditary component in up to 10% of cases; evaluating personal and family histories is a major part of hereditary cancer risk assessment. Mutations in multiple genes cause hereditary cancer, which markedly increase the lifetime risk for many types of cancer. Some of these gene mutations also increase the lifetime risk for other cancers (such as ovarian, uterine, colorectal, sarcomas, brain, leukemia, gastric, thyroid, and prostate).

Significant aspects of my patient’s personal and/or family medical history that suggest a reasonable probability of hereditary cancer are below:

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Based on this, I am requesting coverage for this test (CancerNext-Expanded). CancerNext-Expanded includes comprehensive analysis of 67 genes associated with hereditary cancer: AIP, ALK,APC, ATM, BAP1, BARD1, BLM, BRCA1, BRCA2, BRIP1, BMPR1A, CDH1, CDK4, CDKN1B, CDKN2A, CHEK2, DICER1, EPCAM, FANCC, FH, FLCN, GALNT12, GREM1, HOXB13, MAX, MEN1, MET, MITF, MLH1, MRE11A, MSH2, MSH6, MUTYH, NBN, NF1, NF2, PALB2, PHOX2B, PMS2, POLD1, POLE, POT1, PRKAR1A, PTCH1, PTEN, RAD50, RAD51C, RAD51D, RB1, RET, SDHA, SDHAF2, SDHB, SDHC, SDHD, SMAD4, SMARCA4, SMARCB1, SMARCE1, STK11, SUFU, TMEM127, TP53, TSC1, TSC2, VHL, XRCC2.

Based on the above personal and/or family history, my patient is suspicious for ______syndrome(s). As clinical features of many hereditary cancer syndromes overlap and there is a reasonable probability of detecting a mutation in my patient, this multi-gene test is the most efficient, cost-effective way to analyze the multiple genes associated with hereditary cancer conditions.3 According to published guidelines, germline genetic testing is warranted.1,2

This genetic testing will help estimate my patient’s risk to develop (and potentially die of) cancer. It will also directly impact my patient’s medical management. Many of the genes in this test have published clinical practice guidelines to reduce the risk for cancer and/or detect cancer early, to reduce morbidity and mortality. Management options may include:

·  Increased breast screening including self-examinations, clinical breast examinations, mammogram, ultrasound, and MRI

·  Breast cancer risk reduction using prophylactic mastectomies and/or chemoprevention

·  Risk-reducing salpingo-oophorectomy

·  Prostate cancer screening (PSA and DRE)

·  Annual thyroid ultrasound and exam

·  More frequent colonoscopy

·  Avoidance of radiation treatment when possible

·  Consideration of MRI-based screening/technologies

·  Other: ______

Due to the cancer risks associated with these mutations and interventions available to reduce these risks, this genetic testing is medically indicated. As such, I am ordering this testing as medically necessary and affirm that my patient has provided informed consent for genetic testing.

A positive test result would confirm a genetic diagnosis and/or risk in my patient, and would ensure my patient is being managed appropriately. I am specifying Ambry Genetics Corporation because this laboratory has highly-sensitive and cost-effective testing for hereditary cancer, along with a large database of previously tested patients to ensure highly validated, accurate, and informative test interpretation.

I recommend that you support this request for coverage of diagnostic genetic testing for hereditary cancer in my patient. Genetic testing can take up to several weeks to complete, and the laboratory will not bill until testing is concluded. Therefore, we are requesting that the authorization be valid for 3 months.

Thank you for your time, and please don’t hesitate to contact me with any questions.

Sincerely,

Ordering Clinician Name (Signature Provided on Test Requisition Form)

(MD/DO, Clinical Nurse Specialist, Nurse-Midwives, Nurse Practitioner, Physician Assistant, Genetic Counselor*)

*Authorized clinician requirements vary by state

Test Details

CPT codes:

Laboratory: Ambry Genetics Corporation (TIN 33-0892453 / NPI 1861568784), a CAP-accredited and CLIA-certified laboratory located at 7 Argonaut, Aliso Viejo, CA 92656

References:

1.  NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Genetic/Familial High-Risk Assessment: Breast and Ovarian. Version 2.2017, 12/07/2016.

2.  NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Genetic/Familial High-Risk Assessment: Colorectal. Version 2.2016, 09/26/2016.

3.  Meldrum C, Doyle MA, Tothill RW. Next-generation sequencing for cancer diagnostics: a practical perspective. Clin Biochem Rev. 2011 Nov;32(4):177-95.