Download PREDICT Letter of Med Necessity

March 11th, 2016
RE: Critical Test Coverage Request by the Treating Provider
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Patient: [First Name, Last Name]
Insurance Provider: [Insurance Company Name]
Subscriber Name: [First Name, Last Name]
Policy #: [Subscriber’s Policy Number]
Dear Claim’s Specialist,
I am writing this letter on behalf of my patient, and your subscriber, [First, Last Name] to request
full coverage of a DNA-based hereditary cancer diagnostic test. This patient presents with an
atypical personal and/or familial history of cancer. Without the ability to access patient specific
genetic data, which ultimately provides guidance as to whether I should increase/change my
monitoring and treatment approach, I may be unable to provide this patient with an adequate
level of care.
Significant aspects of my patient’s personal and/or familial medical history that suggest an
increased probability of deleterious mutation are as follows:
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Based on these factors, I am requesting full coverage of the PREDICT94 hereditary cancer test.
PREDICT94 includes comprehensive variant analysis of 94 genes, including: BRCA1, BRCA2,
MLH1, MSH2, MSH6, PMS1 and PMS2. These genes contain well-described variation, and
links between these variants and predisposition for certain cancers (including hereditary
breast/ovarian cancer, Lynch syndrome, Cowden syndrome and Li-Fraumeni syndrome), are
strong. Because clinical features of many of these cancers can overlap, a multi-gene testing
approach is both necessary and cost-efficient.
Breast and ovarian cancers are thought to have a hereditary component in up to 10% and 25% of
cases, respectively; evaluating personal and family histories is a major part of hereditary cancer
risk assessment and subsequent management. Mutations in multiple genes have been
demonstrated to cause cancer, but mutations in BRCA1/BRCA2 are the most common. Women
that carry a BRCA1 or BRCA2 mutation have up to an 87% lifetime risk to develop breast cancer
(compared to 12% in the general population), a 40-60% lifetime risk for a second primary breast
cancer, and a 11-40% lifetime risk to develop ovarian cancer (compared to 1.6% in the general
population.)1 Men that carry a BRCA1 or BRCA2 mutation have an elevated risk for breast and
prostate cancer1. My patient’s personal and/or familial cancer history, and the associated
increase in probability of deleterious, are atypical, and suggest advanced genetic testing is
warranted.
Genetic testing will undoubtedly help me to better estimate this patient’s risk of developing
cancer, and may directly impact their medical management. Many of the gene variants assessed
by the PREDICT94 test have published clinical practice guidelines that can be implemented in
an effort to reduce risk of cancer development, and/or to diagnose the cancer at the earliest
opportunity. This type of intervention has been shown to reduce both morbidity and mortality
rates. Examples of management options suggested in response to the test results include:
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Increased breast examination, including self-examinations, clinical breast
examinations, mammogram, ultrasound, and MRI-based
Risk-reducing prophylactic surgery and/or chemoprevention
Increased Prostate cancer screening (PSA and DRE) events
Increased thyroid examinations
Increased colonoscopy frequency
Consideration of MRI-based screening/technologies
Enhanced guidance as to what level of medical management or intervention is appropriate for my
atypical patient, based on their genetic variation, will be readily available after my review of the
results. Therefore, I am asserting that the PREDICT94 test has sufficient clinical utility to
be deemed medically necessary. I have thoroughly documented evidence supporting my
position in the patient's chart.
I am specifically requesting the PREDICT94 test, developed by LabSolutions, for several
reasons, including:
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the tests composition (more clinically relevant variations being assessed)
the size/strength of their patient result database (larger sampling size)
reporting features of the test ( relevant changes to practice guidelines, open and applicable clinical trials)
Thank you for your timely review and consideration of this request. I recommend that you
support this request of coverage for my patient--their well being may rely upon my ability to
access the data and guidance it provides. Genetic testing may take up to several weeks to
complete, and the laboratory will not bill the insurer until testing is concluded. Therefore, we are
requesting that the authorization be valid for 3 months. The patient is aware of my request, and
an executed genetic test consent form is on file.
If you have questions, or if I can be of any further assistance, please do not hesitate to contact me
at [PHYSICIAN PHONE NUMBER].
Sincerely,
[ORDERING PHYSICIAN]
Authorized clinician requirements may vary by state
(MD/DO, Clinical Nurse Specialist, Nurse-Midwives, Nurse Practitioner, Physician Assistant,
Genetic Counselor)
Laboratory Info:
LabSolutions LLC (TIN 33-0892453 / NPI 1861568784) a high complexity CLIA-certified
clinical laboratory specializing in precision healthcare laboratory services, is located at 1451
Northside Dr NW, Atlanta, GA 30318.
References:
1. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Genetic/Familial
High-Risk Assessment: Breast and Ovarian. Version 2.2014, 09/23/2014.
2. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Genetic/Familial
High-Risk Assessment: Colorectal. Version 2.2014, 05/19/2014.
3. Meldrum C, Doyle MA, Tothill RW. Next-generation sequencing for cancer diagnostics:
a practical perspective. ClinBiochem Rev. 2011 Nov;32(4):177-95.