Sample LMNs MELARIS® SAMPLE LMN #1 – No personal history of cancer; family history of melanoma and/or pancreatic cancer SAMPLE LMN #2 – Family history of a p16 mutation SAMPLE LMN #3 – Personal history of melanoma and/or pancreatic cancer GUIDELINES FOR LETTERS OF MEDICAL NECESSITY (LMNs) A healthcare provider may include an LMN with a pre-authorization request, claim submission, or appeal to facilitate the insurance review process for the benefit of the patient. Our experience with insurance companies is such that we encourage healthcare providers to cover as many of the following points as possible that are applicable to the patient: Explanation that the requested genetic test has been ordered by a physician Explanation of the medical necessity for the test requested If family history is cited, give as much family history as possible, including specifics about relationship to patient, cancer site, age of cancer diagnosis (alternatively, a detailed threegeneration pedigree that contains this information could be attached and referred to in the body of the letter) Patient's diagnosis and prognosis, including age of onset and specific location of cancer Explanation that the genetic test is recognized as appropriate for inclusion in this patient's treatment regimen Treatment plan, including specific statements about anticipated impact of the genetic test on the medical management of patient. We remind you to read through the entire letter to make sure it makes sense for each patient. Please call (800) 469-7423 if Myriad Customer Service may provide further assistance or answer questions. TIPS FOR SAVING AND MODIFYING SAMPLE LMNs This is a Microsoft Word document that is saved as “read-only” to preserve the original wording. To customize, simply use the “save as” command from the “File” menu, which will prompt you to rename the document to something besides the original name. Your newly named document is no longer “read-only” and can be modified and customized as you wish. Adopted 09/05 MELARIS® - SAMPLE LMN #1 No personal history of cancer; family history of melanoma and/or pancreatic cancer [Date] ATTN: [Physician Name, M.D.] [Insurance Company/Institution] [Street Address] [City, State, Zip] Re: [Patient Name or ID/Claim Number] Dear Medical Director: I am writing to request coverage for analysis of the p16 gene for _______________________________________ with a family history of the following: (Relevant cancers include melanoma and pancreatic) Relationship_________________ Cancer Site_______________ Age______ Relationship_________________ Cancer Site_______________ Age______ This history is suggestive of inherited susceptibility for melanoma and/or pancreatic cancer and can often be linked to specific mutations in the p16 gene. Individuals with p16 mutations are at a substantially increased risk for developing malignant melanoma. An inherited mutation in the p16 gene increases the risk of malignant melanoma to 76% by age 80. The identification of such a mutation would significantly alter patient management, including increasing the frequency of close surveillance, biopsy of abnormal moles, and allowing the patient to make lifestyle modifications. Myriad Genetic Laboratories performs a comprehensive sequence analysis of the p16 gene. Sequence analysis is the most sensitive clinical test to look for predisposition mutations and is one of the most complex clinical diagnostic tests that exists today. The technical challenge of traditional DNA analysis represented as "usual and customary" should not apply to the complex analysis involved with p16 sequencing analysis. Please contact me if I can provide you with any additional information. Sincerely, [Physician Signature] Adopted 09/05 MELARIS® - SAMPLE LMN #2 Family history of a p16 mutation [Date] ATTN: [Physician Name, M.D.] [Insurance Company/Institution] [Street Address] [City, State, Zip] Re: [Patient Name or ID/Claim Number] Dear Medical Director: I am writing to request coverage for analysis of the p16 gene for _______________________________________due to a personal history of _____________________________________________________________and a family history of the following: (Relevant cancers include melanoma and pancreatic) Relationship_________________ Cancer Site_______________ Age______ Relationship_________________ Cancer Site_______________ Age______ This history is suggestive of inherited susceptibility for melanoma and/or pancreatic cancer and can often be linked to specific mutations in the p16 gene. Individuals with p16 mutations are at a substantially increased risk for developing malignant melanoma. An inherited mutation in the p16 gene increases the risk of malignant melanoma to 76% by age 80. The identification of such a mutation would significantly alter patient management, including increasing the frequency of close surveillance, biopsy of abnormal moles, and allowing the patient to make lifestyle modifications. Establishing that this patient does not carry the mutation that predisposed (his/her) relatives to develop cancer prevents the unnecessary use of extensive screening measures. Myriad Genetic Laboratories is CLIA-approved to perform single site mutation analysis of the p16 gene. Single site mutation analysis is the most sensitive clinical test to look for specific mutations in this gene. Please contact me if I can provide you with any additional information. Sincerely, [Physician Signature] Adopted 09/05 MELARIS® - SAMPLE LMN #3 Personal history of melanoma and/or pancreatic cancer [Date] ATTN: [Physician Name, M.D.] [Insurance Company/Institution] [Street Address] [City, State, Zip] Re: [Patient Name or ID/Claim Number] Dear Medical Director: I am writing to request coverage for analysis of the p16 gene for _______________________________________due to a personal history of _____________________________________________________________and _____________. This history is suggestive of inherited susceptibility for melanoma and/or pancreatic cancer and can often be linked to specific mutations in the p16 gene. An inherited mutation in the p16 gene increases the risk of malignant melanoma to 76% by age 80. Individuals who have already been diagnosed with melanoma are at a much greater risk of developing a new, separate melanoma. The identification of such a mutation would significantly alter patient management, including increasing the frequency of close surveillance, biopsy of abnormal moles, and allowing the patient to make lifestyle modifications. Myriad Genetic Laboratories performs a comprehensive sequence analysis of the p16 gene. Sequence analysis is the most sensitive clinical test to look for predisposition mutations and is one of the most complex clinical diagnostic tests that exists today. The technical challenge of traditional DNA analysis represented as "usual and customary" should not apply to the complex analysis involved with p16 sequencing analysis. Please feel free to contact me. I will be happy to provide you with any additional information you might require. Sincerely, [Physician Signature] Adopted 09/05