Coverage Policy Manual
Policy #: 2011016
Category: PPACA Preventive
Initiated: September 2010
Last Review: December 2023
  PREVENTIVE SERVICES FOR NON-GRANDFATHERED (PPACA) PLANS: BRCA TESTING; GENETIC COUNSELING AND EVALUATION

Description:
The Federal Patient Protection and Preventive Care Act was passed by Congress and signed into law by the President in March 2010.  The preventive services component of the law became effective 23 September 2010. A component of the law was a requirement that all “non-grandfathered” health insurance plans are required to cover those preventive medicine services given an “A” or “B” recommendation by the U.S. Preventive Services Task Force.  
 
Plans are not required to provide coverage for the preventive services if they are delivered by out-of-network providers.
 
Task Force recommendations are graded on a five-point scale (A-E), reflecting the strength of evidence in support of the intervention.  Grade A: There is good evidence to support the recommendation that the condition be specifically considered in a periodic health examination.  Grade B: There is fair evidence to support the recommendation that the condition be specifically considered in a periodic health examination.  Grade C: There is insufficient evidence to recommend for or against the inclusion of the condition in a periodic health examination, but recommendations may be made on other grounds.  Grade D: There is fair evidence to support the recommendation that the condition be excluded from consideration in a periodic health examination.  Grade E: There is good evidence to support the recommendation that the condition be excluded from consideration in a periodic health examination.
 
Those preventive medicine services listed as Grade A & B recommendations are covered without cost sharing (i.e., deductible, co-insurance, or co-pay) by Health Plans for appropriate preventive care services provided by an in-network provider.  If the primary purpose for the office visit is for other than Grade A or B USPSTF preventive care services, deductible, co-insurance, or copay may be applied.
 
 

Policy/
Coverage:
Effective January 2019
 
Referral for genetic counseling is covered for women with family members with breast, ovarian, tubal or peritoneal cancer who have been identified through screening with a family history that may be associated with an increased risk for the BRCA1 or BRCA2 genes. If indicated, after genetic counseling, BRCA testing is covered for these individuals. This coverage is for members of “non-grandfathered” plans on a once per lifetime basis, without cost-sharing (i.e., deductible, co-insurance, or co-pay).
 
Note: Screening is to be done with a specific screening tool designed to identify a family history that may be associated with the BRCA1 or BRCA2 mutation including but not limited to the Ontario Family History Assessment Tool, Manchester Scoring System, Referral Screening Tool, Pedigree Assessment Tool and FHS-7.
 
The appropriate ICD-10 codes to report these services are Z31.5, Z80.3 or Z80.41, Z80.49, Z85.3, Z85.40, Z85.43, Z85.44.
  
The codes used to report this procedure are 96040 or 99401-99404 or S0265. Genetic testing codes 81162, 81163, 81164, 81212, 81165, 81166, 81215, 81216, 81167, 81217 will be covered under this policy effective January 1, 2019. When the primary purpose of the service is the delivery of an evidence-based service in accordance with a US Preventive Services Task Force A or B rating in effect and other preventive services identified in preventive services mandates (legislative or regulatory), the service may be billed with Modifier ‘-33’. The correct coding as listed for both ICD-10 and CPT or HCPCS codes are also required.
 
Effective prior to June 2014
 
Referral for genetic counseling and evaluation for BRCA testing is covered for women whose family history is associated with an increased risk for deleterious mutations in BRCA1 and BRCA2 genes for members of “non-grandfathered” plans on a once per lifetime basis, without cost-sharing (i.e., deductible, co-insurance, or co-pay):
 
 
The appropriate ICD-9 codes to report these services are V26.33, V16.3, or V16.41
 
The codes used to report this procedure are 96040 or 99401-99404 or S0265.  Genetic testing codes 81211, 81212, 81213, 81214, 81215, 81216, 81217 will be covered under this policy effective May 1, 2013.  When the primary purpose of the service is the delivery of an evidence-based service in accordance with a US Preventive Services Task Force A or B rating in effect and other preventive services identified in preventive services mandates (legislative or regulatory), the service may be billed with Modifier ‘-33’.  The correct coding as listed for both ICD-9 and CPT or HCPCS codes are also required.
 

Rationale:
The U.S. Preventive Services Task Force (USPSTF) recommends referral for genetic counseling and evaluation for BRCA testing in those women with a family history associated with an increased risk of deleterious mutations in BRCA1 or BRCA2 genes (Grade B recommendation).
 
The USPSTF recommendations include the following information:
 
The USPSTF found fair evidence that women with certain specific family history patterns (increased-risk family history) have an increased risk for developing breast or ovarian cancer associated with BRCA1 or BRCA2 mutations. The USPSTF determined that these women would benefit from genetic counseling that allows informed decision making about testing and further prophylactic treatment. This counseling should be done by suitably trained health care providers. There is insufficient evidence to determine the benefits of chemoprevention or intensive screening in improving health outcomes in these women if they test positive for deleterious BRCA1 or BRCA2 mutations. However, there is fair evidence that prophylactic surgery for these women significantly decreases breast and ovarian cancer incidence. Thus, the potential benefits of referral and discussion of testing and prophylactic treatment for these women may be substantial.
 
The USPSTF also found insufficient evidence regarding important adverse ethical, legal, and social consequences that could result from referral and testing of high-risk women. Prophylactic surgery is associated with known harms. The USPSTF estimated that the magnitude of these potential harms is small. The USPSTF concluded that the benefits of referring women with an increased-risk family history to suitably trained health care providers outweigh the harms.
 
These recommendations apply to women who have not received a diagnosis of breast or ovarian cancer. They do not apply to women with a family history of breast or ovarian cancer that includes a relative with a known deleterious mutation in BRCA1 or BRCA2 genes; these women should be referred for genetic counseling. These recommendations do not apply to men.
 
Although there currently are no standardized referral criteria, women with an increased-risk family history should be considered for genetic counseling to further evaluate their potential risks.
 
Certain specific family history patterns are associated with an increased risk for deleterious mutations in the BRCA1 or BRCA2 gene. Both maternal and paternal family histories are important. For non-Ashkenazi Jewish women, these patterns include 2 first-degree relatives with breast cancer, 1 of whom received the diagnosis at age 50 years or younger; a combination of 3 or more first- or second-degree relatives with breast cancer regardless of age at diagnosis; a combination of both breast and ovarian cancer among first- and second-degree relatives; a first-degree relative with bilateral breast cancer; a combination of 2 or more first- or second-degree relatives with ovarian cancer regardless of age at diagnosis; a first- or second-degree relative with both breast and ovarian cancer at any age; and a history of breast cancer in a male relative.
 
For women of Ashkenazi Jewish heritage, an increased-risk family history includes any first-degree relative (or 2 second-degree relatives on the same side of the family) with breast or ovarian cancer.
 
About 2 percent of adult women in the general population have an increased-risk family history as defined here. Women with none of these family history patterns have a low probability of having a deleterious mutation in BRCA1 or BRCA2 genes.
 
Computational tools are available to predict the risk for clinically important BRCA mutations (that is, BRCA mutations associated with the presence of breast cancer, ovarian cancer, or both), but these tools have not been verified in the general population. There is no empirical evidence concerning the level of risk for a BRCA mutation that merits referral for genetic counseling.
 
Not all women with a potentially deleterious BRCA mutation will develop breast or ovarian cancer. In a woman who has a clinically important BRCA mutation, the probability of developing breast or ovarian cancer by age 70 years is estimated to be 35 percent to 84 percent for breast cancer and 10 percent to 50 percent for ovarian cancer.
 
Appropriate genetic counseling helps women make informed decisions, can improve their knowledge and perception of absolute risk for breast and ovarian cancer, and can often reduce anxiety. Genetic counseling includes elements of counseling; risk assessment; pedigree analysis; and, in some cases, recommendations for testing for BRCA mutations in affected family members, the presenting patient, or both. It is best delivered by a suitably trained health care provider.
 
A BRCA test is typically ordered by a physician. When done in concert with genetic counseling, the test assures the linkage of testing with appropriate management decisions. Genetic testing may lead to potential adverse ethical, legal, and social consequences, such as insurance and employment discrimination; these issues should be discussed in the context of genetic counseling and evaluation for testing.
 
Among women with BRCA1 or BRCA2 mutations, prophylactic mastectomy or oophorectomy decreases the incidence of breast and ovarian cancer; there is inadequate evidence for mortality benefits. Chemoprevention with selective estrogen receptor modulators may decrease incidence of estrogen receptor-positive breast cancer; however, it is also associated with adverse effects, such as pulmonary embolism, deep venous thrombosis, and endometrial cancer. Most breast cancer associated with BRCA1 mutations is estrogen receptor-negative and thus is not prevented by tamoxifen. Intensive screening with mammography has poor sensitivity, and there is no evidence of benefit of intensive screening for women with BRCA1 or BRCA2 gene mutations. Magnetic resonance imaging (MRI) may detect more cases of cancer, but the effect on mortality is not clear.
 
Women with an increased-risk family history are at risk not only for deleterious BRCA1 or BRCA2 mutations but potentially for other unknown mutations as well. Women with an increased-risk family history who have negative results on tests for BRCA1 and BRCA2 mutations may also benefit from surgical prophylaxis.
 
The USPSTF has made recommendations on mammography screening for breast cancer, screening for ovarian cancer, and chemoprevention of breast cancer, which can be accessed at http://www.uspreventiveservicestaskforce.org.
 
2014 Update
The USPSTF updated the recommendation for risk assessment, genetic counseling and genetic testing for BRCA-related cancer in women. The recommendations include screening of women with a family history of breast, ovarian, tubal or peritoneal cancer. The coverage statement has been updated to address change.
 
2018 Update
A literature search was conducted through November 2018.  There was no new information identified that would prompt a change in the coverage statement.  

CPT/HCPCS:
81162BRCA1 (BRCA1, DNA repair associated), BRCA2 (BRCA2, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis and full duplication/deletion analysis (ie, detection of large gene rearrangements)
81163BRCA1 (BRCA1, DNA repair associated), BRCA2 (BRCA2, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis
81164BRCA1 (BRCA1, DNA repair associated), BRCA2 (BRCA2, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; full duplication/deletion analysis (ie, detection of large gene rearrangements)
81165BRCA1 (BRCA1, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis
81166BRCA1 (BRCA1, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; full duplication/deletion analysis (ie, detection of large gene rearrangements)
81167BRCA2 (BRCA2, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; full duplication/deletion analysis (ie, detection of large gene rearrangements)
81212BRCA1 (BRCA1, DNA repair associated), BRCA2 (BRCA2, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; 185delAG, 5385insC, 6174delT variants
81215BRCA1 (BRCA1, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; known familial variant
81216BRCA2 (BRCA2, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; full sequence analysis
81217BRCA2 (BRCA2, DNA repair associated) (eg, hereditary breast and ovarian cancer) gene analysis; known familial variant
96040Medical genetics and genetic counseling services, each 30 minutes face to face with patient/family
99401Preventive medicine counseling and/or risk factor reduction intervention(s) provided to an individual (separate procedure); approximately 15 minutes
99402Preventive medicine counseling and/or risk factor reduction intervention(s) provided to an individual (separate procedure); approximately 30 minutes
99403Preventive medicine counseling and/or risk factor reduction intervention(s) provided to an individual (separate procedure); approximately 45 minutes
99404Preventive medicine counseling and/or risk factor reduction intervention(s) provided to an individual (separate procedure); approximately 60 minutes
S0265Genetic counseling, under physician supervision, each 15 minutes

References: Genetic Risk Assessment and BRCA Mutation Testing for Breast and Ovarian Cancer Susceptibility, Topic Page. September 2005. U.S. Preventive Services Task Force. http://www.uspreventiveservicestaskforce.org/uspstf/uspsbrgen.htm

PPACA & HECRA: Public Laws 111-148 & 111-152. The Patient Protection and Affordable Care Act


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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