Medical & Reimbursement Policies
Medical Policy
Policy Id
Topic
Section
Effective Date
Issued Date
Last Revision Date
Annual Review
Prepared By
DISCLAIMER
Highmark medical policy is intended to serve only as a general reference resource regarding coverage for the services described. This policy does not constitute medical advice and is not intended to govern or otherwise influence medical decisions.
POLICY STATEMENT
This policy provides information regarding the coverage of, as determined by applicable federal and/or state legislation.
This policy is designed to address medical necessity guidelines that are appropriate for the majority of individuals with a particular disease, illness or condition. Each person’s unique clinical circumstances warrant individual consideration, based upon review of applicable medical records.
The qualifications of the policy will meet the standards of the National Committee for Quality Assurance (NCQA) and the Delaware Department of Health and Social Services (DHSS) and all applicable state and federal regulations.
Purpose
This medical policy outlines Highmark Health Options services for BRCA1& BRCA2 Genetic Mutation Testing and Related Genetic Counseling.
Definitions
Highmark Health Options (HHO) – Managed care organization serving vulnerable populations that have complex needs and qualify for Medicaid. Highmark Health Options members include individuals and families with low income, expecting mothers, children, and people with disabilities. Members pay nothing to very little for their health coverage. Highmark Health Options currently services Delaware Medicaid: Diamond State Health Plan (DSHP), Delaware Healthy Children Program (DHCP), and Diamond State Health Plan Plus (DSHP) LTSS members.
CHEK2 – A gene on chromosome 22q that encodes a kinase enzyme and influences a person’s susceptibility to breast cancer.
Close Relative – For the purpose of familial assessment, includes first-, second- and third-degree relatives on the same side of the family (maternal or paternal).
First-Degree Relatives – Include parents, children, and siblings, and half-siblings.
Second-Degree Relatives – Include grandparents, aunts, uncles, nieces, nephews, and grandchildren.
Third-Degree Relatives – Include great-grandparents, great-aunts, great-uncles, great-grandchildren, and first cousins.
Triple–Negative Breast Cancer – The term used to describe breast cancer cells that do not have estrogen receptors, progesterone receptors, or large of amounts of HER/neu protein. Also called ER-negative PR-negative HER2/neu-negative and ER-PR-HER2/neu-negative.
Policy Position
Prior Authorization
Prior Authorization may be required. Please validate codes on the Prior Authorization Lookup Tool https://www.highmarkhealthoptions.com/providers/prior-auth-lookup
Procedures
The following medical necessity criteria must be met:
1. Unaffected/asymptomatic individuals (women must be 18 years of age and older) without a personal history of breast cancer (both invasive breast cancer and ductal carcinoma), epithelial ovarian, fallopian tube, or primary peritoneal cancer; AND:
2. Must have a biologically related family member with a known BRCA1 or BRCA2 gene mutation/variant; OR
3. Has a first- or second-degree blood relative meeting any of the criteria outlined below; OR
a) Diagnosed at age 45 years or younger, with or without family history; OR
b) Diagnosed at age less than 50 years with an unknown (e.g., adopted) or limited family history; OR
c) Diagnosed at age 50 years or younger with one or more 1st-, 2nd-, or 3rd degree close blood relatives with breast cancer at any age, and/or one or more close blood relatives with epithelial ovarian, fallopian tube, or primary peritoneal cancer at any age; OR
d) Two breast primaries when first breast cancer diagnosis occurred prior to or at age 50 years. Two breast primaries include bilateral disease or cases where there are two or more clearly separate ipsilateral primary tumors; OR
e) Diagnosed at age 60 years or younger with triple negative (ER-, PR-, HER2) breast cancer; OR
f) Diagnosed at any age and with at least one 1st-, 2nd-, or 3rd- degree relative with breast cancer at age 50 or younger; OR
g) Diagnosed at any age, with at least two 1st-, 2nd-, or 3rd degree relatives with breast cancer diagnosed at any age; OR
h) Diagnosed at any age, with at least one 1st, 2nd-, or 3rd degree relative with epithelial ovarian, fallopian tube, or primary peritoneal cancer diagnosed at any age; OR
i) Diagnosed at any age, with at least two 1st-, 2nd-, or 3rd degree relatives with pancreatic cancer or prostate cancer diagnosed at any age; OR
j) Personal history male breast cancer at any age or male blood relative with breast cancer; OR
k) For an individual or an ethnicity associated with higher mutation frequency (e.g., Ashkenazi Jewish), no additional family history required; OR
4. Has a third-degree blood relative with breast cancer and/or ovarian, fallopian tube, primary peritoneal cancer with two or more close blood relatives with breast cancer (at least one with breast cancer and ≤ 50 years of age) and/or ovarian cancer, fallopian tube, or primary peritoneal cancer.
5. Affected/symptomatic individuals (women must be 18 years of age and older) with a personal history of breast cancer (both invasive breast cancer and ductal carcinoma), epithelial ovarian, fallopian tube or primary peritoneal cancer; AND
a) One or more of the following:
i. Diagnosed at age 45 years or younger, with or without family history; OR
ii. Diagnosed at age less than 50 years with an unknown (e.g., adopted) or limited family history; OR
iii. Diagnosed at age 50 years or younger with one or more 1st-, 2nd-, or 3rd degree relatives with breast cancer at any age, and/or one or more close blood relatives with epithelial ovarian, fallopian tube or primary peritoneal cancer at any age; OR
iv. Two breast primaries when first breast cancer diagnosis occurred prior to or at age 50 years. Two breast primaries include bilateral disease or cases where there are two or more clearly separate ipsilateral primary tumors; OR
v. Diagnosed at age 60 years or younger with triple negative (ER-, PR-, HER2-) breast cancer; OR
vi. Diagnosed at any age, with at least one 1st-, 2nd-, or 3rd- degree relative with breast cancer at age 50 younger; OR
vii. Diagnosed at any age, with at least two 1st-, 2nd-, or 3rd- degree relatives with breast cancer diagnosed at any age; OR
viii. Diagnosed at any age, with at least one 1st-, 2nd-, or 3rd- degree relative with epithelial ovarian, fallopian tube or primary peritoneal cancer diagnosed at any age; OR
ix. Diagnosed at any age, with at least two 1st-, 2nd-, or 3rd- degree relatives with pancreatic cancer or prostate cancer diagnosed at any age; OR
x. 1st-, 2nd-, or 3rd- degree personal history male breast cancer at any age or male relative with breast cancer; OR
xi. Personal history of epithelial ovarian, fallopian tube or primary peritoneal cancer; OR
xii. For an individual or an ethnicity associated with higher mutation frequency (e.g., Ashkenazi Jewish), no additional family history required.
a) Personal history of pancreatic cancer or prostate cancer (Gleason score ≥ 7) at any age and more than one 1st-, 2nd-, or 3rd – degree relative with any of the following:
i. Breast cancer age 50 or greater;
ii. Ovarian, fallopian tube, or primary peritoneal cancer at any age.
6. Repeat BRCA testing with an FDA-approved test (I.e., FoundationFocus) is considered medically necessary for women with ovarian cancer who had another brand of BRCA test and who are being considered for treatment with rucaparib (Rubraca) after two or more previous lines of chemotherapy
7. Large genomic rearrangement testing to identify individuals at risk for BRCA1/2 related cancers is not typically medically necessary (e.g., BARTTM). Therefore, requests for this service will require case-by-case physician review only when both sequencing and testing for common large rearrangements have been performed and are negative.
Note: Generally, genetic testing for a particular disease should be performed once per lifetime; however, there are rare instances in which testing may be performed more than once in a lifetime (e.g., previous testing methodology is inaccurate, or a new discovery has added significant relevant mutations for a disease).
GENETIC COUNSELING
Pre-test and post-test genetic counseling are considered medically necessary and are covered as an adjunct to genetic testing.
Genetic Counseling is required to be performed by an independent (not employed by a genetic testing lab) genetic provider prior to genetic counseling for BRCA mutations. This service is necessary in order to inform persons being tested about the benefits and limitations of a specific genetic test for the specific patient. Genetic testing for BRCA mutation requires documentation of medical necessity from one of the following providers who has evaluated the patient and intends to see the person after testing has been performed for counseling:
- Board Eligible or Board-Certified Genetic Counselor
- Advanced Genetics Nurse
- Genetic Clinical Nurse
- Advanced Practice Nurse in Genetics
- Board Eligible or Board-Certified Clinical Geneticist
- A physician with experience in cancer genetics
WHEN SERVICES ARE NOT COVERED
Services are not covered for conditions other than those listed above because the scientific evidence has not been established.
Genetic testing in minors for BRCA1 or BRCA mutations does not meet the definition of medical necessity. There is no change in management for minors because of knowledge of the presence or absence of a deleterious mutation. In addition, there are potential harms related to stigmatization and discrimination.
Use of the CHEK2 is considered not medically necessary because the efficacy of this test in determining an individual’s risk of cancer has not yet been proven.
Genetic screening in the general population is not covered and is considered not medically necessary.
Direct- to -consumer saliva genetic testing kits for BRCA1 and BRCA2 are considered not medically necessary and therefore, not covered.
POST-PAYMENT AUDIT STATEMENT
The medical record must include documentation that reflects the medical necessity criteria and is subject to audit by Highmark Health Options at any time pursuant to the terms of your provider agreement.
PLACE OF SERVICE
The place of service for BRCA testing is outpatient.
GOVERNING BODIES APPROVAL
Genetic testing is regulated under the Clinical Laboratory Improvement Amendments (CLIA) Act of 1998. Additional information available at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124 105.htm.
SUMMARY OF LITERATURE
Genetic Counseling
The 2015 NCCN guidelines for genetic counseling have counseling services divided into pre-test and post-test categories. The pre-test counseling requirements include:
- Collection of a comprehensive family history (close blood relatives include first-, second-, and third-degree relatives on each side of the family);
- Evaluation of a patient’s cancer risk;
- Generation of a differential diagnosis and education of the patient on inheritance patterns, penetrance, variable expressivity, and the possibility of genetic heterogeneity.
Post-test counseling includes:
- Providing results along with their significance and impact and recommended medical management options;
- Informing and testing at-risk family members;
- Providing available resources such as disease-specific support groups and research studies.
The National Society of Genetic Counselors (NSGC) has recommended that genetic testing be performed utilizing the informed decision-making process (Berliner et al., 2013). Issues included in the process should include the following:
- Obtaining all pertinent personal medical and family history data
- Psychosocial assessment
- Discussion of cancer and mutation risk and how personalized risk estimates are derived
- Facilitation of the informed consent process through discussion of the risks, benefits, limitations, and likelihood of identifying a mutation with genetic susceptibility testing
- Result disclosure, when appropriate
- Discussion of medical management options
- Review of issues related to genetic discrimination
References
American Society of Human Genetics Ad Hoc Committee on Breast and Ovarian Cancer Screening. Statement of the American Society of Human Genetics on genetic testing for breast and ovarian cancer predisposition. Am J Hum Genet. 1994; 55: ii-iv. Accessed on April 11, 2016.
American College of Obstetricians and Gynecologists (ACOG). Hereditary breast and ovarian cancer syndrome. ACOG Practice Bulletin No. 103. Obstet Gynecol. 2009; 113(4):957-966. Accessed on April 11, 2016.
Evans D.G., Gaarenstroom K.N., Stirling D., et al. Screening for familial ovarian cancer: Poor survival of BRCA1/2 related cancers. J Med Genet. 2009; 46(9):593-597. Accessed on April 12, 2016.
American College of Obstetricians and Gynecologists (ACOG). Breast cancer screening. Washington, DC: American College of Obstetricians and Gynecologists (ACOG); August 2011. Accessed on April 12, 2016.
Bayraktar S., Elsayegh N., Gutierrez Barrera A.M., et al. Predictive factors for BRCA1/BRCA2 mutations in women with ductal carcinoma in situ. Cancer. 2012; 118(6):1515-1522. Accessed on April 12, 2016.
Berliner J.L., Fay A.M., Cummings S.A., et al. National Society of Genetic Counselors (NSGC) practice guideline: risk assessment and genetic counseling for hereditary breast and ovarian cancer. J Genet Couns. 2013Apr; 22(2):155-63. Accessed on April 12, 2016.
ECRI Institute. Genetic Test Product Brief. BRAC Analysis® test (Myriad Genetics, Inc.) for assessing risk of hereditary breast and ovarian cancer. December 2014. Accessed on April 12, 2016.
Moyer V.A. Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer in Women: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2014; 160(4):271-281. Accessed on April 12, 2016.
U.S. Preventive Services Task Force (USPSTF). Recommendation Statement: Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer in Women. Release date: December 2013. Accessed on April 12, 2016.
National Cancer Institute (NCI), NCI Fact Sheet- BRCA1 and BRCA2: Cancer Risk and Genetic Testing, last reviewed: 01/22/14. Accessed at cancer.gov 09/09/14. Accessed in April 12, 2016.
National Comprehensive Cancer Network, (NCCN) Clinical Practice Guidelines in Oncology, Genetic/Familial High-Risk Assessment: Breast and Ovarian, V. 1.2015. Accessed on April 12, 2016.
Lancaster J.M., Powell C.B., Chen L.M., et al. Statement on risk assessment for inherited gynecologic cancer predispositions. Gynecologic oncology. Sep 17, 2014, Accessed on April 12, 2016.
Tung N, Battelli C, Allen B, et al. Frequency of mutations in individuals with breast cancer referred for BRCA1 and BRCA2 testing using next-generation sequencing with a 25-gene panel. Cancer. Jan 1, 2015; 121(1):25-33. Accessed on April 12, 2016.
Mitra A.V., Bancroft E.K., Barbachano Y., et al. Targeted prostate cancer screening in men with mutations in BRCA1 and BRCA2 detects aggressive prostate cancer: preliminary analysis of the results of the IMPACT study. BJU Int. Jan 2011; 107(1):28-39. PMID 20840664.Accessed on April 12, 2016.
The Center for Jewish Genetics. Hereditary cancer. Accessed on April 13, 2016.
