Policy Specific Section: Medical Necessity and Investigational / Experimental. October 15, 1997 October 9, 2013

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1 Medical Policy Genetic Testing for Hereditary Breast and/or Ovarian Cancer Type: Medical Necessity and Investigational / Experimental Policy Specific Section: Laboratory/Pathology Original Policy Date: Effective Date: October 15, 1997 October 9, 2013 Definitions of Decision Determinations Medically Necessary: A treatment, procedure or drug is medically necessary only when it has been established as safe and effective for the particular symptoms or diagnosis, is not investigational or experimental, is not being provided primarily for the convenience of the patient or the provider, and is provided at the most appropriate level to treat the condition. Investigational/Experimental: A treatment, procedure or drug is investigational when it has not been recognized as safe and effective for use in treating the particular condition in accordance with generally accepted professional medical standards. This includes services where approval by the federal or state governmental is required prior to use, but has not yet been granted. Split Evaluation: Blue Shield policy review can result in a Split Evaluation, where a treatment, procedure or drug will be considered to be investigational for certain indications or conditions, but will be deemed safe and effective for other indications or conditions, and therefore potentially medically necessary in those instances. Description Several genetic syndromes with an autosomal dominant pattern of inheritance that feature breast cancer have been identified. Of these, hereditary breast and ovarian cancer (HBOC) and some cases of hereditary site-specific breast cancer have causative mutations in breast cancer (BRCA) genes in common. Families suspected of having HBOC syndrome are characterized by an increased susceptibility to breast cancer occurring at a young age, bilateral breast cancer, male

2 breast cancer, and ovarian cancer at any age, as well as cancer of the fallopian tube and primary peritoneal cancer. Other cancers, such as prostate cancer, pancreatic cancer, gastrointestinal cancers, melanoma, and laryngeal cancer, occur more frequently in HBOC families. Hereditary site-specific breast cancer families are characterized by early onset breast cancer with or without male cases, but without ovarian cancer. For this policy, both will be referred to collectively as hereditary breast and/or ovarian cancer. Germline mutations in the BRCA1 and BRCA2 genes are responsible for the cancer susceptibility in the majority of HBOC families, especially if ovarian cancer or male breast cancer are features. However, in site-specific breast cancer, BRCA mutations are responsible for only a portion of affected families and research to date has not yet identified other moderate or high-penetrance gene mutations that account for disease in these families. Breast cancer gene mutations are inherited in an autosomal dominant fashion through either the maternal or paternal lineage. It is possible to test for abnormalities in BRCA1 and BRCA2 genes to identify the specific mutation in cancer cases and to identify family members with increased cancer risk. Family members without existing cancer who are found to have BRCA mutations can consider preventive interventions for reducing risk and mortality. The BRACAnalysis Rearrangement Test is an additional assay proposed to detect rare, large rearrangements of deoxyribonucleic acid (DNA) in the BRCA1 and BRCA2 genes that were previously undetected by standard genetic testing. Cell cycle checkpoint kinase2 (CHEK2) is also involved with DNA repair and human cancer predisposition like BRCA1 and BRCA2. CHEK2 is normally activated in response to DNA double-stranded breaks. CHEK2 regulates the function of BRCA1 protein in DNA repair and also exerts critical roles in cell cycle control and apoptosis. The CHEK2 mutation, 1100delC in exon 10, has been associated with familial breast cancers. Policy BRCA Testing Genetic testing for BRCA1 and BRCA2 mutations in adults (>/= 18 years of age) may be considered medically necessary when any of the following criteria are met: Individual (male or female) from a family with a known deleterious BRCA1/BRCA2 mutation Personal history of breast cancer (including invasive and ductal carcinoma in situ) and one or more of the following circumstances: Diagnosed at age 45 or younger Diagnosed at age 50 or younger with at least one close blood relative* with one or both of the following: Breast cancer at age 50 or younger Epithelial ovarian, fallopian tube or primary peritoneal cancer at any age 2 of 6

3 Two breast primary cancers (includes bilateral disease or cases where there are two or more clearly separate [ipsilateral] tumors) when the first breast cancer diagnosis occurred prior to age 50 Diagnosed prior to age 60 with triple negative breast cancer (neither express estrogen receptor and progesterone receptor, nor overexpress HER2) Diagnosed prior to age 50 with a limited family history (such as fewer than two firstor second-degree female relatives or female relatives surviving beyond 45 years in either lineage) Diagnosed at any age, with at least two close blood relatives* with breast and/or epithelial ovarian, fallopian tube or primary peritoneal cancer at any age Close male blood relative* with breast cancer Personal history of epithelial ovarian, fallopian tube or primary peritoneal cancer Adults of ethnicity associated with higher mutation frequency (e.g., Ashkenazi Jewish, Norwegian, Dutch, or Icelander descent) Personal history of epithelial ovarian, fallopian tube or primary peritoneal cancer Personal history of male breast cancer at any age Personal history of breast and/or ovarian cancer at any age with at least two close blood relatives* with pancreatic cancer at any age Personal history of pancreatic cancer at any age with at least two close blood relatives* with breast and/or ovarian cancer and/or pancreatic cancer at any age An adult without a personal history, but with a family history only of a: First- or second-degree blood relative meeting any of the above criteria A third-degree blood relative with both of the following: Breast cancer and/or ovarian or fallopian tube or primary peritoneal cancer; and At least two close blood relatives* with breast cancer (at least one with breast cancer at age 50 or younger) and/or ovarian cancer BRACAnalysis Rearrangement Test (BART) Testing for large genomic rearrangements of the BRCA1 or BRCA2 genes (BART) to identify adult patients at risk for BCRA1 or BRCA2 related cancers may be considered medically necessary when both of the following are met: Criteria for BRCA1 and BRCA2 testing (as above) Testing for point mutations (BRCA1 and BRCA2) is negative Genetic testing for BRCA1 and BRCA2 mutations and/or large genomic rearrangements (BART) is considered investigational in any of the following situations: Adults not meeting the indications/criteria for BRCA1 and BRCA2, and/or BART testing described above Individuals under the age of 18 Genetic screening in the general population 3 of 6

4 Testing for cell cycle checkpoint kinase2 (CHEK2) genetic abnormalities (mutations, deletions, etc.) is considered investigational in affected or unaffected patients with breast cancer, irrespective of the family history. Policy Guideline Genetic testing should be performed in a setting that has suitably trained healthcare providers who can give appropriate pre- and post-test counseling and that has access to a Clinical Laboratory Improvement Amendments (CLIA)-licensed laboratory that offers comprehensive mutation analysis. *Close Blood Relatives Note: Both maternal and paternal family histories are important and each lineage must be considered separately. Close blood relative include first-, second-, and third-degree relatives: First degree relatives are defined as a blood relative with whom the individual shares approximately 50% of his/her genes, including parents, full-siblings, and children on both maternal and paternal sides Second degree relatives are defined as a blood relative with whom an individual shares approximately 25% of his/her genes, including grandparents, grandchildren, uncles, aunts, nieces, nephews, and half-siblings Third degree relatives are defined as a blood relative with whom an individual shares approximately 12.5% of his/her genes, including first-cousins, great-grandparents or great-grandchildren Unaffected Adults of Potential BRCA Mutation Families As the majority of test results will be negative and uninformative in unaffected family members of potential BRCA mutation families, it is strongly recommended that an affected family member be tested first whenever possible to adequately interpret the test. Should a BRCA mutation be found in an affected family member(s), the deoxyribonucleic acid (DNA) from the unaffected family member can be tested specifically for the same mutation of the affected family member without having to sequence the entire gene. Interpreting the test results for an unaffected family member without knowing the genetic status of the family may be possible in the case of a positive result for an established disease-associated mutation but leads to difficulties in interpreting negative test results or mutations of uncertain significance because the possibility of a causative BRCA mutation is not ruled out. BART Testing Comprehensive BRACAnalysis includes complete sequencing of the BRCA1 and BRCA2 genes and an additional procedure to identify five common large rearrangements in the BRCA1 gene. The BRACAnalysis large rearrangement test (BART) detects large rearrangements that are missed by Comprehensive BRACAnalysis. 4 of 6

5 Prior to August 2006, testing for large deletions and rearrangements (BART) was not performed, thus some patients with familial breast cancer who had negative BRCA testing prior to this time may consider repeat testing for the rearrangements. Ethnicities Associated with Higher Mutation Frequency Testing in eligible individuals who belong to ethnic populations in which there are wellcharacterized founder mutations should begin with tests specifically for these mutations. For example, founder mutations account for approximately three quarters of the BRCA mutations found in Ashkenazi Jewish populations. When the testing for founder mutations is negative, comprehensive mutation analysis should then be performed. BRCA Associated Malignancies Patients with BRCA mutations have an increased risk of prostate cancer, and patients with known BRCA mutations may therefore consider more aggressive screening approaches for prostate cancer. However, the presence of prostate cancer in an individual, or in a family, is not itself felt to be sufficient justification for BRCA testing. Cancers of the fallopian tube and primary peritoneal cancer are also considered BRCAassociated malignancies and are to be considered along with breast and ovarian cancer in assessing the family history. Coding: BRCA 1 and 2 Gene Analysis CPT/HCPCS code Description Complete BRCA 1 and BRCA 2 gene analysis for susceptibility to breast and ovarian cancer; full sequence analysis and common duplication/deletion variants in BRCA Three mutation BRCA1 and BRCA2 analysis for susceptibility to breast and ovarian cancer in Ashkenazi individuals Complete gene sequence analysis of the BRCA1 gene BRCA1 (breast cancer 1) (e.g., hereditary breast and ovarian cancer) gene analysis; known familial variant Complete gene sequence analysis of the BRCA2 gene BRCA2 (breast cancer 2) (e.g., hereditary breast and ovarian cancer) gene analysis; known familial variant BART Testing CPT/HCPCS Description code BRCA1, BRCA2 (breast cancer 1 and 2) (e.g., hereditary breast and ovarian cancer) gene analysis; uncommon duplication/deletion variants 5 of 6

6 CHEK2 Mutation Analysis There are no specific CPT or HCPCS codes for CHEK2 mutation analysis. The following combination of codes may be used. CPT/HCPCS code Description Unlisted molecular pathology procedure G0452 Molecular pathology procedure; physician interpretation and report Documentation Required for Clinical Review History and physical and/or consultation notes including: o Ethnicity/Ancestry o Personal and/or family history of cancer (if applicable) including: Family relationship(s): (maternal or paternal), (living or deceased) (if applicable) Site(s) of cancer Age at diagnosis If breast cancer, indicate if bilateral, premenopausal, or triple negative cancer o BRCA1/BRCA2 mutation history (if applicable) Genetic counseling/professional results (if applicable) Laboratory or Pathology reports (e.g., BRCA results for BART testing requests, or hormone receptor assay) (if applicable) The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illness or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. These Policies are subject to change as new information becomes available. 6 of 6

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