Download Colaris Update Sample LMN

PMS2 or COLARIS UPDATE - SAMPLE LETTER OF MEDICAL NECESSITY
For patients with a negative COLARIS ® not including PMS2 or prior to 5/17/11
[NOTE TO THE HEALTHCARE PROVIDER: If, in your judgment, testing is
medically indicated for this patient, then this is provided for your consideration
as an example of a letter of medical necessity. This may not include all the
information necessary to support your coverage request. You are entirely
responsible for ensuring the accuracy and supportability of all information
provided.]
[Physician Letterhead]
[Date]
ATTN:
[Physician Name, M.D.]
[Medical Director]
[Insurance Company/Institution]
[Street Address]
[City, State, Zip]
Re:
[Patient Name, Date of Birth, ID Number]
Dear Medical Director:
I am writing to request coverage for an “update” to genetic testing for Lynch syndrome
for the above patient. The patient’s history is strongly suggestive of Lynch syndrome,
also known as Hereditary Non-Polyposis Colorectal Cancer or HNPCC. Although
previous genetic testing for this patient’s MLH1, MSH2 and MSH6 genes were negative,
new tests are now clinically available. Coverage is requested for the following tests:
 PMS2 gene analysis. Mutations in this gene account for up to 15% of Lynch
syndrome (Genetics in Medicine 2009;11(1):42-65).
 Large rearrangement testing of MSH6. This patient’s previous testing of the
MSH6 gene included only DNA sequencing. Sequencing does not detect large
gene rearrangements, which account for approximately 10% of mutations in this
gene. (J Med Genet 2003;40:597-600).
 EPCAM gene deletion testing. Deletions in this gene have been found in 2025% of suspected Lynch patients whose tumors demonstrate MSH2 deficiency
but in whom no germline MSH2 mutation is found. (J Molecular Diagnostics
2011;13(1)93-99).
I have determined that this test is medically necessary for the above patient due to the
following history which is suggestive of Lynch syndrome:
[choose one or both bullets]
 a personal history of _________________________________ diagnosed at
age(s) _________________, (and)
 a family history of the following: [Relevant cancers include: colorectal,
endometrial, ovarian, stomach, kidney/urinary tract, biliary tract, small
bowel, central nervous system, pancreatic and sebaceous
adenoma/carcinoma; specify maternal or paternal relatives; specify
multiple primary cancers.]
Relationship_______________ Cancer or Adenoma ___________ Age____
Relationship_______________ Cancer or Adenoma ___________ Age____
Relationship_______________ Cancer or Adenoma ___________ Age____
Relationship_______________ Cancer or Adenoma ___________ Age____
Relationship_______________ Cancer or Adenoma ___________ Age____
Relationship_______________ Cancer or Adenoma ___________ Age____
[Optional section] According to guidelines of the National Comprehensive Cancer
Network and the Society of Gynecologic Oncologists, women diagnosed with
endometrial cancer under age 50 are appropriate candidates for Lynch syndrome
evaluation.
[Optional section] This patient’s [or substitute “the relative’s”] tumor testing is
suggestive of Lynch syndrome because [select one or more bullets]
 The tumor shows microsatellite instability
 Immunohistochemistry of the tumor shows loss of staining of [select one or
more] MLH1/MSH2/MSH6/PMS2.
 Histology of the tumor is indicative of Lynch syndrome
[Optional section] Based on the PREMM1,2,6 model (http://www.danafarber.org/pat/cancer/gastrointestinal/crc-calculator/default.asp) the chance of a Lynch
syndrome mutation in this individual is ____________. Dinh et al. showed that testing
is cost effective when this estimate exceeds 5%, with an average cost effectiveness
ratio of $26,000 per QALY. (Cancer Prev Res 2010;4(1):1–13)
Individuals who carry a Lynch syndrome mutation have lifetime cancer risks of up to
82% for colorectal cancer and up to 71% for endometrial cancer, as well as an
increased risk for ovarian, stomach and other cancers. In addition, mutation carriers
who have already been diagnosed with cancer have a significantly increased risk of
developing another primary cancer. Because medical society guidelines recommend an
aggressive approach to medical management for individuals identified as having a
genetic mutation, test results are necessary in choosing the most appropriate course of
treatment and/or surveillance.
The National Comprehensive Cancer Network, the American College of Obstetricians
and Gynecologists, the Society of Gynecologic Oncologists, and other professional
societies have published guidelines for testing and managing patients with Lynch
syndrome. The American Society of Clinical Oncology recommends that genetic testing
be offered to individuals with suspected inherited cancer risk in whom test results will
aid in medical management decision-making. For this patient in particular, the genetic
test results are needed in order to consider:
[Please check all that apply]
____
____
____
____
____
____
____
Subtotal colectomy
Annual colonoscopy
Upper endoscopy surveillance
Surveillance for increased endometrial and ovarian cancer risk
Prophylactic hysterectomy and bilateral salpingo-ophorectomy
Surveillance for urinary tract cancer
Other [describe] _________________________________________________
The patient has provided informed consent to pursue genetic testing, based on my
discussion of the personal and/or family history, the potential test results, and the
implications for medical management.
Please do not hesitate to contact me if I can provide you with any additional information.
Sincerely,
[Physician Signature and Name]