SAMPLE LETTER OF MEDICAL NECESSITY – COLARIS
NOTE TO THE HEALTHCARE PROVIDER: The following is an example template for a letter of medical necessity for possible use when testing medically appropriate patients. This may not include all the information necessary to support the coverage request. Healthcare providers are 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 genetic testing of MLH1, MSH2, MSH6, PMS2 and EPCAM, the genes associated with Lynch syndrome, also known as Hereditary Non-Polyposis Colorectal Cancer (HNPCC). The test I have ordered to evaluate my patient is called COLARIS. I have determined that this test is medically necessary for the above patient due to the following history which is suggestive of this condition:
Patient Information: [choose one or both of the following tables]
[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.]
Personal HistoryCancer or Adenoma Site / Dx Age
Family History
First-, Second-, or Third-Degree Relative
(Maternal Side or Paternal) / Relationship / Cancer or Adenoma Site / Dx Age
[Patient Information – Cut if not applicable to your patient] 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
[Patient Information - Cut if not applicable to your patient] According to the NCCN Guidelines v1.2014 for Genetic/Familial High-Risk Assessment: Colorectal, individuals with a ≥5% risk of a Lynch syndrome mutation using any mutation prediction model (eg, MMRpro, PREMM[1,2,6], MMRpredict) meet clinical testing criteria. Based on the PREMM1,2,6 model (http://premm.dfci.harvard.edu/) [if a different model was used, insert the name here] 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)
[Patient Information - Cut if not applicable to your patient] This patient has not been affected with cancer, but has a family history of cancer that meets commonly accepted societal guidelines for evaluation of Lynch syndrome. My patient’s relatives who have had a Lynch syndrome-associated cancer are not available for testing because: [choose one]
_____ They are deceased
_____ My patient does not have any contact with the affected relatives
_____ The affected relatives refused testing or have specifically refused to share their testing history or results with my patient
_____ Other: ______
Explanation of Need:
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.
Several professional societies, including those listed below, have published guidelines for testing and managing patients with Lynch syndrome (HNPCC) and these societies recommend that genetic testing be offered to individuals with suspected inherited cancer risk in whom the test results will aid in medical management decision-making:
- National Comprehensive Cancer Network
- Society of Gynecologic Oncologists
- The American Society of Clinical Oncology
- American Congress of Obstetricians and Gynecologists
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-oophorectomy
____ 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. Additional societal support is provided in the following pages.
Please do not hesitate to contact me if I can provide you with any additional information.
Sincerely,
[Physician Signature and Name]
Society Support:
[Optional Support Section 1 – cut if not applicable to your patient] According to the National Comprehensive Cancer Network (NCCN) Guidelines for Colorectal Cancer Screening[1], testing for Lynch syndrome (HRS-1):
· Testing for individuals who meet Revised Bethesda Guidelines (LS-B) and are MSI high or have an absence of staining on IHC. Bethesda guidelines as follows:
o Colorectal cancer diagnosed in a patient who is less than 50 years of age
o Presence of synchronous, metachronous colorectal or other LS-associated tumors (LS-related tumors include colorectal, endometrial, stomach, ovarian, pancreas, ureter and renal pelvis, biliary tract, and brain (usually glioblastoma), sebaceous gland adenomas and keratoacanthomas and carcinoma of the small bowel), regardless of age
o Colorectal cancer with the MSI-H histology (presence of tumor infiltrating lymphocytes, Crohn’s-like lymphocytic reaction, mucinous/signet-ring differentiation, or medullary growth pattern) diagnosed in a patient who is less than 60 years of age
o Colorectal cancer diagnosed in one or more first degree relatives with an LS-related tumor, with one of the cancers being diagnosed under age 50 years
o Colorectal cancer diagnosed in two or more first- or second-degree relatives with LS related tumors, regardless of age.
· Testing for individuals who meet Amsterdam I (LS-C) or Amsterdam II (LS-C) criteria in which tumor testing is not available. Revised Amsterdam criteria as follows:
- ≥3 relatives with an Lynch sydrome-associated cancer (colorectal, endometrial, small bowel, uteter or renal pelvis), plus all of the following:
- One of whom is a first degree relative of the other two:
- at least two successive generations affected;
- at least one of the affected relative diagnosed with an LS- associated cancer should be diagnosed before 50 years of age years
- FAP excluded in any case of colorectal cancer
- Tumors should be verified whenever possible
· At risk family members in families with a known mutation
*LS related tumors include colorectal, endometrial, stomach, ovarian, pancreas, ureter and renal pelvis, biliary tract, and brain (usually glioblastoma), sebaceous gland adenomas and keratoacanthomas and carcinoma of the small bowel
Discussion Section (MS-16):
· An alternative approach is to go directly to germline sequencing in patients determined to have a 5% risk of Lynch syndrome when a tumor is not readily available.
[Optional Support Section 2 – cut if not applicable to your patient] 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 Support Section 3 – cut if not applicable to your patient] According to the Society of Gynecological Oncologists (SGO) Education Committee[2], testing for Lynch syndrome is recommended in the following patients:
· Patients with endometrial or colorectal cancer who meet the revised Amsterdam criteria:
o At least 3 relatives with a Lynch-associated (colorectal, endometrial, small bowel, ureter and renal pelvis) cancer in one lineage
o One affected individual should be a first-degree relative of the other two
o At least 2 successive generations should be affected, and
o At least 1 Lynch-associated cancer should be diagnosed before age 50
· Patients with endometrial and colorectal cancer with the first cancer diagnosed prior to age 50
· Patients with ovarian and colorectal cancer with the first cancer diagnosed prior to age 50
· Patients with colorectal or endometrial cancer with evidence of a mismatch repair defect (i.e. Microsatellite instability (MSI) or immunohistochemical loss of expression of MLH1, MSH2, MSH6 or PMS2)
· Patient with a first or second degree relative with a known mismatch repair gene mutation
The SGO suggests that testing for Lynch syndrome in the following patients may also be helpful:
· Patients with endometrial or colorectal cancer diagnosed prior to age 50
· Patient with endometrial or ovarian cancer and colon or other Lynch-associated tumor at any age
· Patients with endometrial or colorectal cancer and a first degree relative with a Lynch-associated tumor diagnosed prior to age 50
· Patients with colorectal or endometrial cancer diagnosed at any age with 2 or more first or second degree relatives with Lynch-associated tumors, regardless of age
· Patients with a first or second degree relative that meets the above criteria
Lynch –associated tumors include colorectal, endometrial, stomach, ovarian, pancreas, ureter and renal pelvis, biliary tract, and brain (usually glioblastoma), sebaceous gland adenomas and keratoacanthomas and carcinoma of the small bowel
[Optional Support Section 4 – cut if not applicable to your patient] According to the American Society of Clinical Oncology 2003 Guidelines[3], COLARIS and COLARIS AP testing meet ASCO genetic testing guidelines as follows:
o Individuals can be identified with personal or family history features suggestive of hereditary cancer risk
o Test can be adequately interpreted
o Test result will aid in diagnosis or influence medical management of the patient and family
[Optional Support Section 5 – cut if not applicable to your patient] According to Medicare Criteria for Hereditary Colorectal Cancer Genetic Testing[4], Testing for Hereditary Non-polyposis Colorectal Cancer (HNPCC): COLARIS
· Amsterdam II
o Personal history of colorectal or endometrial cancer plus ONE of the following
o ≥2 relatives with an HNPCC-associated cancer (colorectal, endometrial, stomach, ovarian, small bowel, uteter, renal pelvis, biliary tract or glioblastoma), plus all of the following:
§ One of whom is a first degree relative of the other two:
§ ≥ Two successive generations affected;
§ ≥ One affected relative diagnosed with colorectal cancer <50 years: AND
§ FAP excluded in any case of colorectal cancer
· Revised Bethesda
o Colorectal cancer diagnosed in a beneficiary at <50y
o Presence of synchronous or metachronous Lynch-syndrome cancers, regardless of age
o Colorectal cancer with MSI-H histology diagnosed in a beneficiary <60y
o Colorectal cancer with 1 first degree relative with LS cancer, one of which was diagnosed <50y
o Colorectal cancer with 2 first degree relatives with LS cancers, regardless of age
· Has a blood relative with a known Lynch syndrome-related gene mutation
· Endometrial cancer diagnosed in a beneficiary at <50y
· If Revised Bethesda criteria met, then MSI and/or IHC can be performed on colorectal cancer tissue
o If MSI-H and/or loss of IHC staining in colon tumor
* If MLH1, MSH2, and MSH6 testing performed and negative then testing for PMS2 gene mutations.
[1] NCCN. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology- V.1.2014.
[2] The Society of Gynecologic Oncologists Education Committee Statement on Risk Assessment for Inherited Gynecological Cancer Predispositions. Gyn Onc; 107(2007): 159-162.
[3] ASCO. American Society of Clinical Oncology policy statement update: Genetic testing for cancer susceptibility. J Clin Oncol 2003; 21(12):2397-2406.
[4] Summary of Medicare Criteria for Genetic Testing. Medicare policy. Effective June 15, 2011.