PROVIDER POLICIES & PROCEDURES

PROVIDER POLICIES & PROCEDURES BRCA GENETIC TESTING The purpose of this document is to provide guidance to providers enrolled in the Connecticut Medical Assistance Program (CMAP) on the requirements for the prior authorization of BRCA Mutation Testing for breast and ovarian cancer susceptibility. This includes the applicable coverage guidelines and limitations for HUSKY Health Program members as well as the procedures for requesting authorization for these services. Genetic testing provides information that can be used to diagnose genetic diseases and susceptibility to diseases or conditions that are inherited. Such testing includes studying chromosomes to the level of individual genes, biochemical testing for the possible presence of genetic diseases, and identifying mutant forms of genes associated with increased risk of developing genetic disorders. The results of a genetic test can be used to confirm or rule out a genetic condition or to help determine an individual s chance of developing a genetic condition or passing on a genetic disorder. Results are often used to influence choices about health care and management of an identified genetic disorder or susceptibility to one. Several hundred genetic tests are currently available. The use of genetic testing for point mutations in the BRCA1 and BRCA2 genes may influence individual management in a variety of ways. Individuals with point gene mutation may consider increased surveillance for breast cancer, or consider a prophylactic mastectomy or oophorectomy. Family members of an individual with a known point mutation, who test negative for a mutation, can forego increased surveillance and/or consideration of prophylactic surgery. Genetic testing for point mutations BRCA1 and BRCA2 genes has emerged as a widely accepted test, when accompanied by genetic counseling. The BRACAnalysis Rearrangement Test (BART) is a refinement of the BRCA genetic tests and is purported to detect rare, large rearrangements of deoxyribonucleic acid (DNA) in the BRCA 1 and BRCA 2 genes which were previously undetected by standard genetic testing. The manufacturer (Myriad Genetic Laboratories) reports that BART testing will identify an additional approximate 3% of BRCA 1 and BRCA2 mutations in very high-risk families and is intended for use only in women at an exceptionally high risk for breast cancer who have previously tested negative for BRCA 1 and BRCA 2 sequence mutations. CLINICAL GUIDELINE Coverage guidelines for molecular testing for breast and/or ovarian cancer BRCA Mutation Testing will be made in accordance with the DSS definition of Medical Necessity and in line with published recommendations and guidelines disseminated by organizations including the U.S. Preventive Services Task Force, the American College of Medical Genetics, and the National Comprehensive Cancer Network. The following criteria are guidelines only. Coverage guidelines are based on an individual 1

assessment of the member and his or her clinical needs. Testing for the purpose of diagnosing a genetic disorder or identifying an individual member who is at risk for a late onset or slowly evolving genetic disorder may be considered clinically appropriate when: 1. A specific mutation or set of mutations has been identified and broadly accepted by credible medical societies to be reliably associated with the condition; and 2. The genetic disorder cannot be identified through biological or other testing; and 3. The member displays clinical features of or may be at increased risk of inheriting the mutation in question; and 4. The results of the genetic test would materially impact the medical management of the member with resulting improvement in health outcomes; and 5. Testing is accompanied by genetic counseling. BRCA Mutation Testing may be considered clinically appropriate for members who meet criteria in any one of the following categories: A. For individuals with a personal history of cancer, genetic testing for a BRCA1 or BRCA2 mutation, associated with genetic counseling, may be considered clinically appropriate when: 1. The individual has a history of breast cancer and at least 1 relative with breast cancer diagnosed prior to age 45; OR 2. The individual was diagnosed with breast cancer prior to age 50; OR 3. The individual has multiple primary breast cancers or bilateral breast cancer; OR 4. The individual is a male with breast cancer; OR 5. The individual has triple negative breast cancer diagnosed prior to age 60; OR 6. The individual has a history of breast cancer and 2 or more first-, second- or third-degree relatives with pancreatic cancer; OR 7. The individual has a history of ovarian, fallopian tube or primary peritoneal cancer; OR 8. The individual has a history of pancreatic cancer and 2 or more first-, second-, or third-degree relatives with breast and/or ovarian and/or pancreatic cancer; OR 9. The individual has a history of breast cancer and 2 or more first-, second- or third-degree relatives with breast or ovarian, fallopian tube, or primary peritoneal cancer; OR 10. The individual has a history of breast cancer and belongs to a population at risk for specific mutations due to ethnic background (for example, Ashkenazi Jewish, Icelandic, Swedish, Hungarian or Dutch descent). B. For individuals with a family history of cancer, genetic testing for a BRCA1 or BRCA2 mutation, associated with genetic counseling, may be clinically appropriate when they have a relative who would meet ANY of the following, but that relative is not available for testing: 1. The individual has a first- or second-degree relative with breast cancer who also had at least 1 relative with breast cancer diagnosed prior to age 45; OR 2. The individual has a first- or second-degree relative who had breast cancer diagnosed prior to age 50; OR 3. The individual has a first- or second-degree relative who had multiple primary breast cancers or bilateral breast cancer; OR 4. The individual has a first- or second-degree relative who has a history of ovarian, fallopian tube, or primary peritoneal cancer; OR 5. The individual has a first- or second-degree male relative who developed breast cancer; OR 2

6. The individual has a first- or second-degree relative who had triple negative breast cancer diagnosed prior to age 60; OR 7. The individual has a first- or second-degree relative with a history of breast cancer and 2 or more first-, second-, or third-degree relatives with pancreatic cancer; OR 8. The individual has a first- or second-degree relative who has a history of ovarian cancer and 2 or more first- second- or third-degree relatives with pancreatic cancer; OR 9. The individual has a first- or second-degree relative with a history of pancreatic cancer and 2 or more first-, second-, or third-degree relatives with breast and/or ovarian and/or pancreatic cancer. C. For individuals with a family history of 3 or more first-, second- or third-degree relatives with ovarian, fallopian tube or primary peritoneal cancer or breast cancer, (at least one of which has breast cancer at or before age 50), genetic testing for a BRCA1 or BRCA2 mutation, associated with genetic counseling, is generally considered clinically appropriate. D. Large genomic rearrangement testing (BART) to identify individuals at risk for BRCA1/2 related cancers is generally considered clinically appropriate for individuals who meet any of the criteria above for BRCA1/2 genetic sequence testing, but have negative results from that testing. Note: The U.S. Preventive Services Task Force recommends against routine referral for genetic counseling or routine breast cancer susceptibility (BRCA) testing for women whose family history is not associated with an increased risk for deleterious mutations in BRCA genes. NOTE: EPSDT Special Provision Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) is a federal Medicaid requirement that requires the Connecticut Medical Assistance Program (CMAP) to cover services, products, or procedures for Medicaid enrollees under 21 years of age where the service or good is medically necessary health care to correct or ameliorate a defect, physical or mental illness, or a condition identified through a screening examination. The applicable definition of medical necessity is set forth in Conn. Gen. Stat. Section 17b-259b (2011) [ref. CMAP Provider Bulletin PB 2011-36]. PROCEDURE Prior authorization of BRCA Mutation Testing is required. Coverage determinations will be based upon a review of requested and/or submitted case-specific information. Information Required for Review: 1. Fully completed State of Connecticut, Department of Social Services Outpatient Prior Authorization Request form or fully completed prior authorization request via web portal; and 2. Clinical information supporting the need for requested services to include pertinent clinical and family history; and 3. Other information as requested by CHNCT. Review Process: Requests for coverage of BRCA testing will be reviewed by CHNCT in accordance with procedures in place for reviewing requests for genetic testing. 3

Requesting Authorization: Requests for the prior authorization of BRCA testing must be submitted using the code specific to the test being requested (see table below). The code must be supported by the codes billed prior to January 2012 as stacked codes with the number of units for each. Example: Request made for CPT code 81211-1 unit Included on the prior authorization form are the supporting stacked codes with the number of units for each: 83891 # units 83909 # units 83904 # units 83898 # units 83912 # units Reimbursement: The code specific to the test requested (e.g. 81211) will be priced at the sum of the Medicaid fees for the stacked codes in accordance with the listed per unit fee for each. EFFECTIVE DATE This Policy is effective for prior authorization requests for BRCA Mutation Testing for HUSKY Health Program members on or after January 1, 2012. LIMITATIONS Not Applicable CODES: Code Definition 81211 BRCA 1, BRCA 2 (breast cancer 1 and 2) (e.g., hereditary breast and ovarian cancer) gene analysis; full sequence analysis and common duplication/deletion variants in BRCA1 (i.e., exon 13 del 3.835kb, exon 13 dup 6kb, exon 14-20 del 26kb, exon 22 del 510bp, exon 8-9 del 7.1kb) 81212 BRCA 1, BRCA 2 (breast cancer 1 and 2) (e.g., hereditary breast and ovarian cancer) gene analysis; 185delAG, 5385insC, 6174delT variants 81213 BRCA 1, BRCA 2 (breast cancer 1 and 2) (e.g., hereditary breast and ovarian cancer) gene analysis; uncommon duplication/deletion variants 81214 BRCA1 (breast cancer 1) (e.g., hereditary breast and ovarian cancer) gene analysis; full sequence analysis and common duplication/deletion variants (i.e., exon 13del 3.835kb, exon 13 dup 6kb, exon 14-20 del 26kb, exon 22 del 510bp, exon 8-9 del 7.1kb 81215 BRCA1 (breast cancer 1) (e.g., hereditary breast and ovarian cancer) gene analysis; known familial variant 81216 BRCA2 (breast cancer 2) (e.g., hereditary breast and ovarian 4

Code Definition cancer) gene analysis; full sequence analysis 81217 BRCA2 (breast cancer 2) (e.g., hereditary breast and ovarian cancer) gene analysis; known familial variant DEFINITIONS 1. BRCA Genes: BRCA genes include cancer susceptibility gene 1 (BRCA1) and/or breast cancer susceptibility gene 2 (BRCA2). 2. Breast Cancer: A cancer starting in the cells of breast tissue in females and males; for the purpose of BRCA mutation testing including invasive or ductal carcinoma in situ. 3. Close Blood Relative: A 1 st degree relative (i.e., mother, sister, daughter); or a 2 nd degree relative (i.e., aunt, grandmother, niece); or a 3 rd degree relative (i.e., first cousin, great parent). 4. Current Procedural Terminology (CPT): The most recent edition of a listing, published by the American Medical Association, of descriptive terms and identifying codes for reporting medical services performed by providers. 5. HUSKY A: Connecticut children and their parents or a relative caregiver; and pregnant women may qualify for HUSKY A (also known as Medicaid). Income limits apply. 6. HUSKY B: Uninsured children under the age of 19 in higher income households may be eligible for HUSKY B (also known as the Children s Health Insurance Program) depending on their family income level. Family cost-sharing may apply. 7. HUSKY C: Connecticut residents who are age 65 or older or residents who are ages 18-64 and who are blind, or have another disability, may qualify for Medicaid coverage under HUSKY C (this includes Medicaid for Employees with Disabilities (MED-Connect), if working). Income and asset limits apply. 8. HUSKY D: Connecticut residents who are ages 19-64 without dependent children and who: (1) do not qualify for HUSKY A; (2) do not receive Medicare; and (3) are not pregnant, may qualify for HUSKY D (also known as Medicaid for the Lowest-Income populations). 9. HUSKY Health Program: The HUSKY A, HUSKY B, HUSKY C, HUSKY D and HUSKY Limited Benefit programs, collectively. 10. HUSKY Limited Benefit Program or HUSKY, LBP: Connecticut s implementation of limited health insurance coverage under Medicaid for individuals with tuberculosis or for family planning purposes and such coverage is substantially less than the full Medicaid coverage. 11. HUSKY Plus Physical Program (or HUSKY Plus Program): A supplemental physical health program pursuant to Conn. Gen. Stat. 17b-294, for medically eligible members of HUSKY B in Income Bands 1 and 2, whose intensive physical health needs cannot be accommodated within the HUSKY Plan, Part B. 12. Medically Necessary or Medical Necessity: (as defined in Connecticut General Statutes 17b- 259b) Those health services required to prevent, identify, diagnose, treat, rehabilitate or ameliorate an individual's medical condition, including mental illness, or its effects, in order to attain or maintain the individual's achievable health and independent functioning provided such services are: (1) Consistent with generally-accepted standards of medical practice that are defined as standards that are based on (A) credible scientific evidence published in peerreviewed medical literature that is generally recognized by the relevant medical community, (B) recommendations of a physician- specialty society, (C) the views of physicians practicing in relevant clinical areas, and (D) any other relevant factors; (2) clinically appropriate in terms of type, frequency, timing, site, extent and duration and considered effective for the individual's illness, injury or disease; (3) not primarily for the convenience of the individual, the individual's health care provider or other health care providers; (4) not more costly than an alternative 5

service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the individual's illness, injury or disease; and (5) based on an assessment of the individual and his or her medical condition. 13. Ovarian Cancer: Ovarian cancer is a cancer of the ovary. For the purpose of BRCA mutation testing it includes both fallopian tube and primary peritoneal carcinoma. 14. Prior Authorization: A process for approving covered services prior to the delivery of the service or initiation of the plan of care based on a determination by CHNCT as to whether the requested service is medically necessary. ADDITIONAL RESOURCES AND REFERENCES: American Medical Association, Current Procedural Terminology Manual: 2014 DSS Provider Bulletin 2012-26: Consolidated Laboratory Fee Schedule Update, dated June 2012 U.S. Preventive Services Task Force. Genetic risk assessment and BRCA mutation testing for breast and ovarian cancer susceptibility. Agency for Healthcare Research and Quality: Rockville, MD; September 2005. American College of Medical Genetics (ACMG). Genetic susceptibility to breast and ovarian cancer: Assessment, counseling and testing guidelines. ACMG: Bethesda, MD; 1999. National Comprehensive Cancer Network (NCCN). Genetic/familial high-risk assessment: breast and ovarian. NCCN Clinical Practice Guidelines in Oncology. V.1.2012. PUBLICATION HISTORY Status Date Action Taken Original publication October 2012 Reviewed December 2013 Clinical Quality Sub-Committee Review. Reference updated. These changes approved at the December 16, 2013 Clinical Quality Sub-Committee meeting. Reviewed December 2014 Clinical Quality Sub-Committee Review Reference updated. Change approved at the December 15, 2014 Clinical Quality Sub-Committee meeting. Updated August 2015 HUSKY Program definitions updated at request of DSS. 6