Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Genetic Testing for Inherited Breast Cancer 1 (BRCA1) and Breast Cancer 2 (BRCA2) Mutations (Independence Administrators)

Policy #:06.02.06p

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.


This policy only applies to members for whom Independence Administrators serves as the claims administrator. For all other Independence members, refer to the policy entitled eviCore Lab Management Program.

The intent of this policy is to communicate the coverage positions for genetic testing for inherited breast cancer 1 (BRCA1) and breast cancer 2 (BRCA2) gene mutations.

For information on policies related to this topic, refer to the Cross References section in this policy.

The provision of benefits for all services related to Genetic Testing for Inherited Breast Cancer 1 (BRCA1) and Breast Cancer 2 (BRCA2) Mutations is in accordance with the individual's benefit contract and varies by product and group. Therefore, individual member benefits must be verified. Some services may be subject to medical necessity criteria, coverage limits, or existing contractual exclusions.

For the purpose of this medical policy and the associated medical necessity criteria below, first-degree relatives include parents, children, and siblings. Second-degree relatives include grandparents, aunts, uncles, nieces, nephews, grandchildren, and half-siblings. Third-degree relatives include great-grandparents, great-aunts, great-uncles, great-grandchildren, and first-cousins. For the purpose of familial assessment, 1st-, 2nd-, and 3rd-degree relatives are blood relatives on the same side of the family (maternal or paternal). For purposes of this policy, first-, second- and third-degree relatives are considered close relatives.

When the medical necessity criteria outlined below are met for an individual, refer to the TESTING STRATEGY in the Guidelines Section of this medical policy bulletin for particular order / sequence of testing, (eg., testing for familial variants versus common variants versus full gene sequencing of BRCA1 and/or BRCA2), per specific clinical scenarios.

The Policy Statements and Criteria in this section of the medical policy bulletin are based on current clinical guidelines from National Comprehensive Cancer Network (NCCN), and are in alignment with current clinical guidelines from American Society of Clinical Oncology and Society of Gynecologic Oncologists.

MEDICALLY NECESSARY

TESTING FOR PATHOGENIC VARIATIONS IN THE BRCA1 AND/OR BRCA2 GENES
Genetic testing for inherited breast cancer 1 (BRCA1) and breast cancer 2 (BRCA2) gene mutations is considered medically necessary and, therefore, covered for any of the following individuals:

Unaffected/Asymptomatic Individuals
  • Biologically related individual of a family with a known BRCA1/BRCA2 gene mutation
  • First- or second-degree blood relative meeting any of the criteria outlined under the affected / symptomatic section below
  • 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 less than or equal to 50 years of age) and/or ovarian cancer/fallopian tube/primary peritoneal cancer

Affected/Symptomatic Individuals
  • Personal history of epithelial ovarian/fallopian tube/primary peritoneal cancer
  • Personal history of male breast cancer
  • Personal history of pancreatic cancer at any age with two or more close blood relatives with breast/and or ovarian/fallopian tube/primary peritoneal cancer and/or pancreatic or prostate cancer at any age
  • Personal history of breast cancer and one or more of the following:
    • Diagnosed at age 45 years or younger, with or without family history
    • Diagnosed at age less than 50 years with a unknown or limited family history
    • Diagnosed at age 50 years or younger with one or more close blood relatives with breast cancer at any age, and/or one or more close blood relatives with epithelial ovarian/fallopian tube/primary peritoneal cancer at any age
    • 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.)
    • Diagnosed at age 60 years or younger with a triple negative (ER-, PR-, HER2-) breast cancer.
    • Diagnosed at any age, with at least one close blood relative with breast cancer diagnosed at age 50 or less
    • Diagnosed at any age, with at least two close blood relatives with breast cancer diagnosed at any age
    • Diagnosed at any age, with at least one close blood relative with epithelial ovarian/fallopian tube/primary peritoneal cancer diagnosed at any age
    • Diagnosed at any age, with at least two close blood relatives with pancreatic cancer or prostate cancer diagnosed at any age
    • Close male blood relative with breast cancer
    • Personal history of epithelial ovarian/fallopian tube/primary peritoneal cancer
    • For an individual of an ethnicity associated with higher mutation frequency (eg, Ashkenazi Jewish), no additional family history may be required.

TESTING FOR GENOMIC REARRANGEMENTS OF THE BRCA1 AND BRCA2 GENES

Testing for genomic rearrangements of the BRCA1 and BRCA2 genes is considered medically necessary and, therefore, covered for individuals who meet the criteria for BRCA testing above and whose testing for point mutations, (i.e., an alteration in DNA sequence caused by a single nucleotide base change, insertion, or deletion), is negative. (See the TESTING STRATEGY in the Guidelines Section of this medical policy bulletin for more information).

GENETIC COUNSELING

Pre-test and post-test genetic counseling is considered medically necessary and, therefore, covered as an adjunct to genetic testing.

EXPERIMENTAL/INVESTIGATIONAL

Unless medical necessity criteria listed above are met, genetic testing for inherited breast cancer 1 (BRCA1) and breast cancer 2 (BRCA2) gene mutations is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

Panels of tests that include the testing of BRCA1 and/or BRCA2 gene variants, (e.g., myRisk Hereditary Cancer Panel, BRCAplus, BreastNext Next-Gen Cancer Panel, OvaNext Next-Gen Cancer Panel, and CancerNext Next-Gen Cancer Panel) as a component or components of the panel testing, are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

NOT MEDICALLY NECESSARY

Genetic testing for inherited breast cancer 1 (BRCA1) and inherited breast cancer (BRCA2) gene mutations is considered not medically necessary and, therefore, not covered for any of the following individuals:
  • Individuals younger than 18 years of age, as it is not known how these test results would change medical management
  • Unaffected individuals in the absence of a known BRCA1 or BRCA2 gene mutation (ie, individuals with no personal and/or familial history of breast and/or ovarian cancer)

When a benefit exists, genetic testing is an eligible service only for the covered individual’s clinical benefit. Testing, (including genetic testing), of associated family members, without a Company benefit, is not eligible for reimbursement.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

For purposes of this policy, breast cancer is inclusive of invasive and ductal carcinoma in situ breast cancers.

Individuals who have received an allogenic bone marrow transplant should not have molecular genetic testing via blood or buccal samples due to contamination by donor DNA. DNA should be extracted from a fibroblast culture.

Independent consideration of the maternal and paternal sides of the family is typically made for familial patterns of breast and/or epithelial ovarian/fallopian tube, and/or pancreatic, and/or primary peritoneal cancer.

US PREVENTIVE SERVICES TASK FORCE (USPSTF)

Current USPSTF guidelines recommend screening women with any family history of breast, ovarian,
tubal, or peritoneal cancer. Women with positive screening results should receive genetic counseling and, if indicated after counseling, BRCA testing. (Grade B Recommendation; Recommended). USPSTF recommends against routine genetic counseling or BRCAtesting for women whose family history is not associated with an increased risk for potentially harmful mutations in the BRCA1or BRCA2 gene. (Grade D recommendation; Not recommended).

TESTING STRATEGY FOR INDIVIDUALS WHO MEET THE MEDICALLY NECESSARY CRITERIA

When medical necessity criteria are met for BRCA1 and BRCA2 testing, the following testing strategy is supported:

KNOWN FAMILIAL VARIANT
In individuals with a known familial BRCA mutation, targeted testing (ie., testing of familial variants for the specific mutation is recommended (CPT code 81215 and/or CPT code 81217).

UNKNOWN FAMILIAL VARIANT
In individuals with an unknown familial BRCA mutation:
    Non-Ashkenazi Jewish Descent
    • To identify clinically significant mutations, National Comprehensive Cancer Network (NCCN) advises testing a relative who has breast or ovarian cancer, especially with early-onset disease, bilateral disease, multiple primaries, or ovarian cancer, because that individual has the highest likelihood for a positive test result.
    • If no living family member with breast or ovarian cancer exists, NCCN suggests testing first- or second-degree family members affected with cancer thought to be related to deleterious BRCA1/BRCA2 mutations (e.g., prostate cancer, pancreatic cancer, melanoma).
    • If no familial mutation can be identified, two possible testing strategies are:
      • Full sequencing followed by testing for common large genomic rearrangements (deletions/duplications) only if sequencing detects no mutation (negative result).
        • More than 90% of BRCA mutations will be detected by full sequencing.
      • Alternatively, simultaneous full sequencing and testing for common large genomic rearrangements (also known as comprehensive BRCA testing may be considered, as is recommended by NCCN (CPT Code: 81211).
        • Comprehensive testing can detect 92.5% of BRCA1/BRCA2 mutations. Comprehensive mutation analysis currently includes sequencing the coding regions and intron/exon splice sites, as well as tests to detect common large deletions and rearrangements that can be missed with sequence analysis alone (CPT Code: 81211).
    • If comprehensive BRCA testing is negative, testing for uncommon large genomic rearrangements (eg, BART™) is an option, if medical necessity criteria for this testing are met (81213).
      • Testing for uncommon large rearrangements should not be done unless both sequencing and testing for common large rearrangements have been performed and are negative.
        • Among individuals with negative comprehensive testing, BART™ identified a deleterious mutation (positive result) in less than 1% of individuals tested.

    Ashkenazi Jewish Descent
    • In individuals of known Ashkenazi Jewish descent, NCCN recommends testing for the 3 known founder mutations (185delAG and 5182insC in BRCA1; 6174delT in BRCA2) first (CPT code 81212).
    • If testing is negative for founder mutations, comprehensive genetic testing may be considered (CPT Code: 81211).
      • Comprehensive mutation analysis currently includes sequencing the coding regions and intron/exon splice sites, as well as tests to detect common large deletions and rearrangements that can be missed with sequence analysis alone (CPT Code: 81211).

OTHER CONSIDERATIONS AND RECOMMENDATIONS

TESTING UNAFFECTED INDIVIDUALS
In unaffected family members of potential BRCA mutation families, most test results will be negative and uninformative. Therefore, it is strongly recommended by NCCN 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), DNA from an unaffected family member can be tested specifically for the same mutation of the affected family member without having to sequence the entire gene. Interpreting 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 (uninformative negative) or mutations of uncertain significance because the possibility of a causative BRCAmutation is not ruled out.

HIGH-RISK ETHNIC GROUPS
Testing in eligible individuals who belong to ethnic populations in which there are well-characterized 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 testing for founder mutations is negative, comprehensive mutation analysis may then be considered. [Comprehensive mutation analysis currently includes sequencing the coding regions and intron/exon splice sites, as well as tests to detect common large deletions and rearrangements that can be missed with sequence analysis alone (CPT Code: 81211)].

PROSTATE CANCER
Men with known BRCA mutations have an increased risk of prostate cancer, and men with known BRCAmutations may therefore consider more aggressive screening approaches for prostate cancer. However, the presence of prostate cancer in a man, or in a family, is not itself considered sufficient justification for BRCA testing.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, genetic testing for inherited breast cancer 1 (BRCA1) and breast cancer 2 (BRCA2) gene mutations is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as not medically necessary or experimental/investigational are not eligible for coverage or reimbursement by the Company.

Genetic testing is appropriate only when offered in a setting with adequately trained health care professionals to provide appropriate pre- and post-test counseling. A qualified Clinical Laboratory Improvement Amendments (CLIA) laboratory should perform the test.

The Company’s laboratory network has extensive genetic testing capabilities; therefore, providers should refer members only to participating laboratories for covered services. In the unusual circumstance that a specific covered test and related services are not available through a participating laboratory, providers must contact the Company to obtain preapproval.

Members who have out-of-network benefits may choose to use a non-participating laboratory for a medically necessary service, but they will have greater out-of-pocket costs associated with that service. In addition, the member will be financially responsible for the entire cost of any service that is non-covered (e.g., a service that is considered experimental/investigational).

BILLING GUIDELINES

Genetic counseling provided by a trained genetic counselor to an individual or family to investigate family genetic history and assessment of the associated risks should be reported using the specific Current Procedural Terminology (CPT) code (96040) or Healthcare Common Procedure Coding System (HCPCS) level II code (S0265) for this service.

For genetic counseling and education provided by a physician to an individual, report the appropriate level evaluation and management (E&M) service.

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

Description

Familial cancer research has identified breast cancer 1 (BRCA1) and breast cancer 2 (BRCA2) genes that may determine an individual's future risk for developing breast and/or ovarian cancer. BRCA gene mutations are inherited in an autosomal-dominant pattern through either the maternal or the paternal lineage in families with a high risk of mutation in the BRCA1 or BRCA 2 gene. Normally, these genes act as tumor suppressors; however, an abnormality (mutation) in the deoxyribonucleic acid (DNA) sequencing of these genes may indicate a possibility of developing hereditary breast and/or ovarian cancer.

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 in common causative mutations in BRCA (breast cancer susceptibility) genes. Families suspected of having HBOC syndrome are characterized by an increased susceptibility to breast cancer occurring at a young age, bilateral breast cancer, male breast cancer, 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.

Germline mutations in the BRCA1and BRCA2 genes are responsible for the cancer susceptibility in most HBOC families, especially if ovarian cancer or male breast cancer are features. However, in site-specific breast cancer, BRCA mutations are responsible only for a proportion 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. BRCA 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.

Although the characteristics of BRCA1 and BRCA2 gene mutations are modestly different, they are commonly considered together, as their similarities outweigh their differences. Commercial testing is available for BRCA1 and BRCA2 defect assessment. The defect can be transmitted through the maternal and/or paternal sides of the family, but not all children inherit the mutation. In addition, not everyone who inherits the mutation develops cancer.

An expanded family medical history that includes first-, second-, and third-degree relatives (parents, children, siblings, aunts, uncles, nieces, nephews, grandparents, grandchildren, half-siblings, great-grandparents, great-aunts, great-uncles, great-grandchildren, first cousins) is integral to identifying men and women who may be candidates for genetic counseling and for BRCA testing for specific risk interventions. Family medical history may include types of cancers, age at diagnosis, risk-reducing surgeries, carcinogen exposure, and documentation records of primary cancers. While both maternal and paternal family histories are important, each lineage must be considered separately. Families suspected of hereditary breast and/or ovarian cancer typically present with cancer occurring at an early age, in multiple generations, and often bilaterally, suggesting an autosomal-dominant pattern of inheritance. However, even when an individual has family members who are identified in one of the aforementioned groups, the predisposition does not guarantee that the individual will develop cancer.

The goal of genetic testing for BRCA gene mutations is to assess an individual's risk for developing breast and/or ovarian cancer, not to determine whether cancer will develop or to provide a timeframe for cancer development. The results of genetic testing for BRCA gene mutations should directly affect the medical management of the individual and/or family. Genetic counseling is generally beneficial to the individual and/or family before and after testing for BRCA gene mutations to review the individual's history, discuss the role of heredity in the disease, communicate genetic risks, and provide psychosocial support. In general, genetic counseling may have clinical value to any individual who is undergoing genetic testing to confirm, diagnose, or exclude any genetic condition. Current literature suggests health benefits for both women and men associated with the early communication of hereditary risks.

Breast cancer has been associated with other hereditary conditions, such as Li-Fraumeni syndrome, Cowden disease, and ataxia telangiectasia; however, there are no studies linking these conditions to BRCA mutations.

According to current published literature, screening of the general population for BRCA gene mutations is not recommended, nor is widespread screening recommended for those unaffected individuals with no personal or family history of breast and/or ovarian cancer, or individuals younger than 18 years of age. Clinical utility has not been established for the use of genetic testing for BRCA mutations has limited or no clinical utility in individuals younger than 18 years of age. This is because there is no change in management for individuals younger than 18 years of age as a result of knowledge of the presence or absence of a deleterious mutation. In its updated (2014) statement on risk assessment for inherited gynecologic cancer, the Society of Gynecologic Oncologists (SGO) acknowledged that the risk of developing breast or ovarian cancer in a woman younger than age 21 is very low, “even in families with inherited cancer susceptibility as a result of hereditary breast and ovarian cancer (HBOC) syndrome.” Because detection of an HBOC-associated mutation “would change the management of very few women in this age group,” and because of potential negative consequences of testing, SGO - in its most recent recommendations - “does not recommend genetic testing of women younger than age 21 for HBOC in the absence of a family history of extremely early-onset cancer.”

BRCA1 and BRCA2 gene testing typically involves the direct sequence analysis of the BRCA1 and BRCA2 coding regions and splice junctions, and testing for large genomic rearrangements in high-risk individuals who are negative for a sequence variant. For individuals with Ashkenazi Jewish (AJ) ancestry, the first step in the analysis is typically testing for the three most common variants in this population (c.68_69delAG [commonly referred to as 187delAG] and c.5266dupC [commonly referred to as 5385insC] in BRCA, and c.5947delT [commonly referred to as 6174delT] in BRCA2).For individuals from families transmitting a known pathogenic BRCA1 or BRCA2 gene variant, American College of Obstetricians and Gynecologists (ACOG) recommends testing specifically for the familial variant is generally sufficient. A number of studies have shown that a significant percentage of women with a strong family history of breast cancer and negative tests for BRCA gene mutations have large genomic rearrangements (including deletions or duplications) in one of these genes. The BRACAnalysis Large Rearrangement Test (BART) is performed to detect these additional large genomic rearrangements in both BRCA1 and BRCA2 genes that are not currently identified as part of standard BRCA analysis testing. BART is intended for use in individuals at high risk for breast cancer who have previously tested negative for sequence mutations and common large rearrangements.

The interpretation of a BRCA1 and BRCA2 gene test result often depends on a individual's family history. In general, the possible outcomes of BRCA1 and BRCA2 gene testing are a positive test result (the identification of a variant known to be deleterious), a negative test result (no disease-causing variant identified), or the identification of a variant of unknown clinical significance (VUS). However, while a negative result in a family transmitting a known BRCA1 and BRCA2 gene variant would be considered a true-negative, a negative result in an unaffected individual from a family without a genetically defined diagnosis of HBOC may be considered uninformative. Consequently, it is recommended that BRCA1 and BRCA2 gene testing be performed first in an affected family member prior to any predisposition testing in unaffected relatives.

An important limitation of BRCA1 and BRCA2 gene testing is the identification of VUS, the frequency of which may range from 4.4% to 16.2% according to the data published by Pal et al., 2005; Simard et al., 2007; Palma et al., 2008; Haffty et al., 2009; Seong et al., 2009; Hall et al., 2010; Alsop et al., 2012. A variety of methods exist for assessing the pathogenicity of a BRCA1 and BRCA2 VUS. One of the largest studies examining the classification of BRCA1 and BRCA2 VUS retrospectively analyzed the results from 70,000 BRCA1 and BRCA2 gene tests (Easton et al., 2007). This analysis yielded 1433 VUS in 4623 individuals. Three separate measures were utilized to estimate the probability of a specific variant being deleterious: (1) the co-occurrence of a VUS with a deleterious variant in a single individual; (2) personal and family history profiles consistent with those carrying a pathogenic variant versus those with no deleterious alteration; and (3) cosegregation of the VUS with disease in pedigrees. Based on analyses using these measures, 133 (9.3%) VUS had odds ratio of at least 100:1 in favor of being neutral (or nonpathogenic) and 43 (6.6%) VUS had odds of at least 20:1 in favor of being deleterious (Easton et al., 2007).

The likelihood of identifying a disease-causing BRCA1 or BRCA2 gene variant depends on the individual's personal and family histories. A variety of tools have been developed to determine the probability of identifying a deleterious BRCA1 and BRCA2 gene variant, in order to identify suitable candidates for testing. Available models, each of which has its own advantages and disadvantages, include the Couch model, the BRCAPRO computer program, the Myriad Prevalence Tables, the Manchester Scoring System, the Ontario Family History Risk Assessment Tool (FHAT), the University of Pennsylvania (Penn) II Risk Model, and the National Cancer Institute (NCI) Breast Cancer Risk Estimation Tool. Some other ecommended screening tools designed to identify a family history that may be associated with an increased risk for potentially harmful mutations in BRCA1or BRCA2 are Referral Screening Tool (RST), Pedigree Assessment Tool (PAT), and Family History Screen (FHS-7).

In sum, hereditary breast and ovarian cancer (HBOC) syndrome describes the familial cancer syndromes that are related to mutations in the BRCA genes (BRCA1 located on chromosome 17q21 and BRCA2 located on chromosome 13q12-13). Identification of individuals with BRCA mutations may lead to enhanced screening and/or surveillance that could lead to improved outcomes. The presence of a BRCA1 or BRCA2 mutation confers a high lifetime risk for breast and ovarian cancer among affected women. These mutations may be gene sequence variations or large rearrangements/deletions. Knowledge of mutation status in individuals at risk of a BRCA mutation may impact health care decisions to reduce risk. Risk-reducing options include intensive surveillance, chemoprophylaxis, prophylactic mastectomy, or prophylactic oophorectomy. Criteria for testing high-risk women have been developed by the National Comprehensive Cancer Network (NCCN), the U.S. Preventive Services Task Force (USPSTF), and other professional bodies. Definitions of high risk vary somewhat, and there is not widespread agreement on optimal criteria that should be used for defining high risk. When testing high-risk women, health outcomes are improved; therefore, testing high-risk women for BRCA1 and BRCA2 mutations may have clinical value.
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Lancaster JM, Powell CB, Chen LM, et al. Statement on risk assessment for inherited gynecologic cancer predispositions. Gynecologic oncology. Sep 17 2014. PMID 25238946

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Lesnock JL, Darcy KM, Tian C, et al. BRCA1 expression and improved survival in ovarian cancer patients treated with intraperitoneal cisplatin and paclitaxel: a Gynecologic Oncology Group Study. British journal of cancer. Apr 2 2013;108(6):1231-1237. PMID 23462720

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Malone KE, Daling JR, Doody DR, et al. Prevalence and predictors of BRCA1 and BRCA2 mutations in a population-based study of breast cancer in white and black American women ages 35 to 64 years. Cancer research. Aug 15 2006;66(16):8297-8308. PMID 16912212

Mavaddat N, Peock S, Frost D, et al. Cancer risks for BRCA1 and BRCA2 mutation carriers: results from prospective analysis of EMBRACE. Journal of the National Cancer Institute. Jun 5 2013;105(11):812-822. PMID 23628597

Menkiszak J, Rzepka-Gorska I, Gorski B, et al. Attitudes toward preventive oophorectomy among BRCA1 mutation carriers in Poland. European journal of gynaecological oncology. 2004;25(1):93-95. PMID 15053071

Metcalfe K, Lynch HT, Ghadirian P, et al. Contralateral breast cancer in BRCA1 and BRCA2 mutation carriers. J Clin Oncol. Jun 15 2004;22(12):2328-2335. PMID 15197194

Metcalfe K, Lubinski J, Lynch HT, et al. Family history of cancer and cancer risks in women with BRCA1 or BRCA2 mutations. Journal of the National Cancer Institute. Dec 15 2010;102(24):1874-1878. PMID 21098759

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

81162, 81212, 81215, 81216, 81217, 81163, 81164, 81165, 81166, 81167


THE FOLLOWING CODE IS APPROPRIATE WHEN REPORTED BY A GENETIC COUNSELOR. WHEN PERFORMED BY A PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL, THE PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL SHOULD USE THE APPROPRIATE EVALUATION AND MANAGEMENT EXAM CODES:

96040



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

See Attachment A


HCPCS Level II Code Number(s)



THE FOLLOWING CODE IS USED TO REPRESENT INTERPRETATION AND REPORT:

G0452 Molecular pathology procedure; physician interpretation and report


THE FOLLOWING CODE IS USED TO REPRESENT GENETIC COUNSELING BEFORE AND AFTER GENETIC TESTING FOR BRCA1 AND BRCA2:

S0265 Genetic counseling, under physician supervision, each 15 minutes



Revenue Code Number(s)

N/A


Misc Code

N/A:



Coding and Billing Requirements


Cross References

Attachment A: Genetic Testing for Inherited Breast Cancer 1 (BRCA1) and Breast Cancer 2 (BRCA2) Mutations (Independence Administrators)
Description: ICD-10 codes




Policy History

06.02.06p
01/01/2019Effective 01/01/2019, the following changes have been made to this policy due to coding updates:

The following procedure codes have been deleted:

81211
81213
81214

Narratives of the following procedure codes have been revised:

81162
81212
81215
81216
81217


The following procedure codes have been added:

81163
81164
81165
81166
81167

06.02.06o
11/21/2018This policy has been reissued in accordance with the Company's annual review process.
11/22/2017This policy has been reissued in accordance with the Company's annual review process.


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 01/01/2019
Version Issued Date: 01/02/2019
Version Reissued Date: N/A

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