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Genetic Testing for RET Proto-Oncogene Germline Mutations Last Review Date: November 11, 2016 Number: MG.MM.DM.LA.17aCv3 Medical Guideline Disclaimer Property of EmblemHealth. All rights reserved. The treating physician or primary care provider must submit to EmblemHealth the clinical evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will not be able to properly review the request for prior authorization. The clinical review criteria expressed below reflects how EmblemHealth determines whether certain services or supplies are medically necessary. EmblemHealth established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). EmblemHealth expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by EmblemHealth, as some programs exclude coverage for services or supplies that EmblemHealth considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. EmblemHealth Services Company LLC, (“EmblemHealth”) has adopted the herein policy in providing management, administrative and other services to HIP Health Plan of New York, HIP Insurance Company of New York, Group Health Incorporated and GHI HMO Select, related to health benefit plans offered by these entities. All of the aforementioned entities are affiliated companies under common control of EmblemHealth Inc. Definition RET proto-oncogene Medullary thyroid cancer Multiple endocrine neoplasia Type 2 (MEN2) Pheochromocytoma The only gene known to be associated MEN Type 2, it is divided into three subtypes: MEN 2A, MEN 2B and familial medullary thyroid carcinoma (FMTC). A malignant tumor of the calcitonin-secreting parafollicular C cells of the thyroid that occurs sporadically or as a component of multiple endocrine neoplasia (MEN) Type 2. A hereditary disorder which manifests as medullary thyroid carcinoma, hyperparathyroidism and phaechromocytoma, is caused by mutations in the RET protooncogene. A neuroendocrine tumor of the adrenal medulla (arising from the chromaffin cells) glands which is usually benign: 50% with MEN2A affected. Guideline Genetic testing for RET proto-oncogene point mutations to assess multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid cancer risk is considered medically necessary when the results of testing will directly impact treatment any of the following criteria are met: 1. Member’s family harbor defined RET mutations 2. Member’s family has a history of inherited MTC or pheochromocytoma, but presence of RET gene mutation is unknown 3. Member’s has a 1st degree relative with MTC and germline RET mutations 4. Member’s has sporadic MTC Limitations/Exclusions Genetic testing is not considered medically necessary for genes additional to the RET. Genetic Testing for Testing for RET Proto-Oncogene Germline Mutations Last review: November 11, 2016 Page 2 of 3 Revision History 1/8/2016: Title changed from Genetic Testing for Medullary Thyroid Carcinoma to Genetic Testing for RET ProtoOncogene Germline Mutations and Definition section enhanced. Applicable Procedure Codes 81404 Molecular pathology procedure, Level 5 (eg, analysis of 2-5 exons by DNA sequence analysis, mutation scanning or duplication/deletion variants of 6-10 exons 81405 Molecular pathology procedure, Level 6 (eg, analysis of 6-10 exons by DNA sequence analysis, mutation scanning or duplication/deletion variants of 11-25 exons 81406 Molecular pathology procedure Level 7 88271 Molecular cytogenetics; DNA probe, each (eg, FISH) Applicable ICD-10 Diagnosis Codes C73 Malignant neoplasm of thyroid gland C74.00 Malignant neoplasm of cortex of unspecified adrenal gland C74.01 Malignant neoplasm of cortex of right adrenal gland C74.02 Malignant neoplasm of cortex of left adrenal gland C74.10 Malignant neoplasm of medulla of unspecified adrenal gland C74.11 Malignant neoplasm of medulla of right adrenal gland C74.12 Malignant neoplasm of medulla of left adrenal gland C74.90 Malignant neoplasm of unspecified part of unspecified adrenal gland C74.91 Malignant neoplasm of unspecified part of right adrenal gland C74.92 Malignant neoplasm of unspecified part of left adrenal gland C75.0 Malignant neoplasm of parathyroid gland E31.22 Multiple endocrine neoplasia [MEN] type IIA E31.23 Multiple endocrine neoplasia [MEN] type IIB Z83.41 Family history of multiple endocrine neoplasia [MEN] syndrome Genetic Testing for Testing for RET Proto-Oncogene Germline Mutations Last review: November 11, 2016 Page 3 of 3 References 1. Online Mendelian Inheritance in Man® (OMIM) Database. 2015. http://omim.org/entry/155240. Accessed June 30, 2015. 2. Carson EB, McMahon M, Baylin SB, Nelkin BD. Ret gene silencing is associated with Raf-1-induced medullary thyroid carcinoma cell line differentiation. Cancer Res. 1995;55:2048-2052. 3. Eng C, Clayton D, Schuffenecker I, et al. The relationship between specific RET proto-oncogene mutations and disease phenotype in multiple endocrine neoplasia type 2. International RET mutation consortium analysis. JAMA. 1996;276(19):1575-1579. 4. Eng C, Mulligan LM, Healey CS, et al. Heterogeneous mutation of the RET proto-oncogene in subpopulations of medullary thyroid carcinoma. Cancer Res. 1996b;56:2167-2170. 5. Eng C, Mulligan LM, Smith DP, et al. Mutation in the RET proto-oncogene in sporadic medullary thyroid carcinoma. Genes Chrom Cancer. 1995;12:209-212. 6. Eng C, Smith DP, Mulligan LM, et al. Point mutation within the tyrosine kinase domain of the RET protooncogene in multiple endocrine neoplasia type 2B and related sporadic tumours. Hum Mol Genet 1994;3:237241. 7. Frilling A, Weber F, Tecklenborg C, Broelsch CE. Prophylactic thyroidectomy in multiple endocrine neoplasia: The impact of molecular mechanisms of RET proto-oncogene. Langenbecks Arch Surg. 2003;388(1):17-26. 8. Kouvaraki MA, Shapiro SE, Perrier ND, et al. RET proto-oncogene: A review and update of genotype-phenotype correlations in hereditary medullary thyroid cancer and associated endocrine tumors. Thyroid. 2005;15(6):531544. 9. Le HN, Norton JA. Perspective on RET proto-oncogene and thyroid cancer. Cancer J. 2000;6(2):50-57. 10. Mulligan LM, Marsh DJ, Robinson BG, et al. Genotype-phenotype correlation in multiple endocrine neoplasia type 2: Report of the International RET Mutation Consortium. J Intern Med. 1995;238(4):343-346.