Policy and Procedure. Department: Utilization Management. SNP, CHP, MetroPlus Gold, Goldcare I&II, Market Plus, Essential, HARP

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1 Retired Date: Page 1 of 9 1. POLICY DESCRIPTION: BRCA 1&2 Genetic Testing 2. RESPONSIBLE PARTIES: Medical Management Administration, Utilization Management, Integrated Care Management, Pharmacy, Claim Department, Providers Contracting. 3. DEFINITIONS: Close relative: 1st, 2nd, or 3rd degree relative (a parent, full sibling, half sibling, child, g grandparent, great-grandparent, grandchild, aunt, great aunt, uncle, great uncle, nephew, niece or first cousin) on the same side of the family Limited family history: Fewer than two first- or second-degree female relatives or female relatives surviving beyond 45 years in either lineage (maternal and paternal). 4. POLICY: 1. Age Criteria; If member diagnosed: A. at age less than or equal to 45 or B. at age less than or equal to 50 and I. Member has an unknown or limited family history II. Has an additional breast cancer primary¹ III. At least one close blood relative² with breast cancer IV. At least one close blood relative with pancreatic cancer V. At least one relative with prostate cancer with Gleason score of 7 or higher or C. Age less than or equal to 60 and I. Triple negative breast cancer a. ( Estrongen ER -, Progesterone PR- and Human Epidermal growth factor receptor 2, (HER2) - D. Diagnosed at any age and

2 Retired Date: Page 2 of 9 I. at least two close blood relatives with breast cancer, pancreatic cancer or prostate cancer (Gleason score at least 7) II. at least one close blood relative² with breast cancer diagnosed at 50 or younger III. at least one close blood relative² with ovarian carcinoma³ IV. a close male blood relative with breast cancer² V. member with an ethnicity associated with higher mutation frequency (e.g. Ashkenazi Jewish ancestry 4 2. Stand-alone reasons to test; A. Member has a personal history of Ovarian³ Carcinoma B. Member has a personal history of male breast cancer C. BRCA 1 / 2 mutation detected by tumor profiling in the absence of germline mutation analysis D. Member from a family with known deleterious BRCA 1/ BRCA 2 gene mutation 3. Other factors; A. Personal history of Prostate Cancer (Gleason score 7 or above) at any age with I. at least one close blood relative 2 with ovarian carcinoma at any age or II. breast cancer at age 50 or less or III. two relatives with breast, pancreatic, or prostate cancer (Gleason score at least a 7) at any age B. Personal history of Pancreatic Cancer at any age with I. at least one close blood relative 2 with ovarian carcinoma at any age or II. breast cancer at age 50 or younger or III. two relatives with breast cancer, pancreatic cancer or prostate cancer (Gleason score 7 or more) at any age C. Personal history of Pancreatic cancer and Ashkenazi Jewish ancestry 4. Members with family history only; A. 1st or 2nd degree blood relative 2 meeting any of the above criteria B. 3rd blood relative 5 who has breast cancer and / or ovarian carcinoma (4/e) and

3 Retired Date: Page 3 of 9 I. Has at least 2 close blood relatives 2 with breast cancer (with one of them having the cancer at age 50 or less) and /or II. Ovarian carcinoma 3 1. Two breast cancer primaries included bilateral disease or two or more clearly separate ipsilateral primary tumors either with synchronously or asynchronously. 2. Close blood relative includes first, second, and third degree relatives on the same side of the family 3. Includes fallopian tube and primary peritoneal cancer. BRCA related ovarian cancers are associated with epithealial non mucinous histology. Lynch syndrome can be associated with both mucinous and non-mucinous epithelial tumors. Be attentive to clinical evidence of Lynch syndrome. Specific types of non epithelial ovarian cancers and tumors can also be associated with other rare syndromes. Examples include an association between sex- cord tumors with annular tubules and Peutz Jeghers syndrome or Sertoli Leydig tumors and DICER1 related disorders 4 Testing for Ashkenazi founder specific mutation(s) should be performed first. Comprehensive genetic testing may be considered if ancestry also includes non Ashkenazi Jewish relatives or if other BRCA related criteria are met. Founder mutations exist in other populations 5. APPLICABLE PROCEDURE CODES: CPT Description BRCA1, BRCA2 (breast cancer 1 and 2) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis and full duplication/deletion analysis BRCA1, BRCA2 (breast cancer 1 and 2) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis and common duplication/deletion variants in BRCA1 (ie, exon 13 del 3.835kb, exon 13 dup 6kb, exon del 26kb, exon 22 del 510 bp, exon 8 9 del 7.1kb) BRCA1, BRCA2 (breast cancer 1 and 2) (eg, hereditary breast and ovarian cancer) gene analysis; 185 delag, 5385insC, 6174delT variants Brca1, BRACAS2 (breast cancer 1 and 2)(eg hereditary breatst and ovarian cancer)gene analysis; uncommon duplication/deletion variants BRCA1 (breast cancer 1) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis and common duplication/deletion variants

4 Retired Date: Page 4 of 9 (ie, exon 13 del 3.835kb, exon 13 dup 6kb, exon del 26kb, exon 22 del 510 bp, exon 8 9 del 7.1kb) BRCA1(Breastcancer1)(eg, hereditary breast and ovarian cancer) gene analysis; known familial variant BRCA2 (Breast Cancer2)(eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis 6. APPLICABLE DIAGNOSIS CODES: CODE Description C Malignant neoplasm of nipple and areola, right female breast C Malignant neoplasm of nipple and areola, left female breast C Malignant neoplasm of nipple and areola, unspecified female breast C Malignant neoplasm of nipple and areola, right male breast C Malignant neoplasm of nipple and areola, left male breast C Malignant neoplasm of nipple and areola, unspecified male breast C Malignant neoplasm of central portion of right female breast C Malignant neoplasm of central portion of left female breast C Malignant neoplasm of central portion of unspecified female breast C Malignant neoplasm of central portion of right male breast C Malignant neoplasm of central portion of left male breast C Malignant neoplasm of central portion of unspecified male breast C Malignant neoplasm of upper inner quadrant of right female breast

5 Retired Date: Page 5 of 9 C Malignant neoplasm of upper inner quadrant of left female breast C Malignant neoplasm of upper inner quadrant of unspecified female breast C Malignant neoplasm of upper inner quadrant of right male breast C Malignant neoplasm of upper inner quadrant of left male breast C Malignant neoplasm of upper inner quadrant of unspecified male breast C Malignant neoplasm of lower inner quadrant of right female breast C Malignant neoplasm of lower inner quadrant of left female breast C Malignant neoplasm of lower inner quadrant of unspecified female breast C Malignant neoplasm of lower inner quadrant of right male breast C Malignant neoplasm of lower inner quadrant of left male breast C Malignant neoplasm of lower inner quadrant of unspecified male breast C Malignant neoplasm of upper outer quadrant of right female breast C Malignant neoplasm of upper outer quadrant of left female breast C Malignant neoplasm of upper outer quadrant of unspecified female breast C Malignant neoplasm of upper outer quadrant of right male breast C Malignant neoplasm of upper outer quadrant of left male breast C Malignant neoplasm of upper outer quadrant of unspecified male breast C Malignant neoplasm of lower outer quadrant of right female breast

6 Retired Date: Page 6 of 9 C Malignant neoplasm of lower outer quadrant of left female breast C Malignant neoplasm of lower outer quadrant of unspecified female breast C Malignant neoplasm of lower outer quadrant of right male breast C Malignant neoplasm of lower outer quadrant of left male breast C Malignant neoplasm of lower outer quadrant of unspecified male breast C Malignant neoplasm of axillary tail of right female breast C Malignant neoplasm of axillary tail of left female breast C Malignant neoplasm of axillary tail of unspecified female breast C Malignant neoplasm of axillary tail of right male breast C Malignant neoplasm of axillary tail of left male breast C Malignant neoplasm of axillary tail of unspecified male breast C Malignant neoplasm of overlapping sites of right female breast C Malignant neoplasm of overlapping sites of left female breast C Malignant neoplasm of overlapping sites of unspecified female breast C Malignant neoplasm of overlapping sites of right male breast C Malignant neoplasm of overlapping sites of left male breast C Malignant neoplasm of overlapping sites of unspecified male breast C Malignant neoplasm of unspecified site of right female breast C Malignant neoplasm of unspecified site of left female breast

7 Retired Date: Page 7 of 9 C Malignant neoplasm of unspecified site of unspecified female breast C Malignant neoplasm of unspecified site of right male breast C Malignant neoplasm of unspecified site of left male breast C Malignant neoplasm of unspecified site of unspecified male breast C56.1 Malignant neoplasm of right ovary C56.2 Malignant neoplasm of left ovary C56.9 Malignant neoplasm of unspecified ovary D05.10 Intraductal carcinoma in situ of unspecified breast D05.11 Intraductal carcinoma in situ of right breast D05.12 Intraductal carcinoma in situ of left breast D05.80 Other specified type of carcinoma in situ of unspecified breast D05.81 Other specified type of carcinoma in situ of right breast D05.82 Other specified type of carcinoma in situ of left breast D05.90 Unspecified type of carcinoma in situ of unspecified breast D05.91 Unspecified type of carcinoma in situ of right breast D05.92 Unspecified type of carcinoma in situ of left breast Z15.01 Genetic susceptibility to malignant neoplasm of breast

8 Retired Date: Page 8 of 9 Z15.02 Genetic susceptibility to malignant neoplasm of ovary Z80.3 Family history of malignant neoplasm of breast Z80.41 Family history of malignant neoplasm of ovary Z85.3 Personal history of malignant neoplasm of breast Z85.43 Personal history of malignant neoplasm of ovary Z Personal history of in situ neoplasm of breast 7. REFERENCES: Version , 12/07/16 National Comprehensive Cancer Network, Inc. 8. REVISION LOG: REVISIONS DATE Creation date 7/20/2017 Approved: Date: Approved: Date: Sosler Bruce, MD Clinical Medical Director Talya Schwartz, MD Chief Medical Officer

9 Retired Date: Page 9 of 9 Medical Guideline Disclaimer: Property of Metro Plus Health Plan. All rights reserved. The treating physician or primary care provider must submit MetroPlus Health Plan clinical evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, Metroplus Health Plan will not be able to properly review the request for prior authorization. The clinical review criteria expressed in this policy reflects how MetroPlus Health Plan determines whether certain services or supplies are medically necessary. MetroPlus Health Plan 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). MetroPlus Health Plan 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 andor paid for by MetroPlus Health Plan, as some programs exclude coverage for services or supplies that MetroPlus Health Plan considers medically necessary. If there is a discrepancy between this guidelines 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 website links are accurate at time of publication. MetroPlus Health Plan has adopted the herein policy in providing management, administrative and other services to our members, related to health benefit plans offered by our organization.

Genetic Testing for BRCA1 and BRCA2 Genes

Genetic Testing for BRCA1 and BRCA2 Genes MP9478 Covered Service: Prior Authorization Required: Additional Information: Yes when meets criteria below Yes as shown below Pre and post-test genetic counseling