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    OpenPayerPolicy UpdatesGenetic & Molecular TestingMassHealth BRCA Genetic Testing Coverage | OpenPay…
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    CurrentMassachusetts Executive Office of Health and Human ServicesPolicy MNG-GT-BRCA_2025-06

    Guidelines for Medical Necessity Determination for Genetic Testing for BRCA-related Breast and/or Ovarian Cancer

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    This policy governs MassHealth medical-necessity review and prior authorization for germline BRCA1, BRCA2, and PALB2 testing for hereditary breast, ovarian, pancreatic, and prostate cancer risk. It applies to MassHealth members and providers, with coverage determined case by case and generally limited to one test episode per lifetime.

    Policy Summary
    PayerMassachusetts Executive Office of Health and Human Services
    PolicyGuidelines for Medical Necessity Determination for Genetic Testing for BRCA-related Breast and/or Ovarian Cancer
    Policy CodePolicy MNG-GT-BRCA_2025-06
    Change TypeRevisionno material clinical or coverage change
    Effective DateJun 25, 2025
    Next Review DateN/A
    Key ActionSubmit the prior authorization request and all supporting documentation electronically through the Provider Online Service Center.
    SourceLink

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    POLICY UPDATE CHANGES

    The policy was revised and supersedes the prior policy version.

    Once per lifetimeMaximum covered frequency for BRCA-related genetic testing
    18+Minimum age criterion for adults at high risk
    4Coverage indication categories
    BRCA1, BRCA2, PALB2Primary genes addressed
    PA requiredPrior authorization requirement

    Coverage Criteria

    General Adult Medical-Necessity Criteria

    MassHealth considers genetic testing for BRCA-related cancer medically necessary once per lifetime when all of the following criteria are met.

    ALL of the following

    • The member is 18 years of age or older.
    • The results of genetic testing will be clinically useful (i.e., will provide added value compared with not using the test) in the clinical management of the member.
    • The member has given prior written consent for genetic testing in accordance with Massachusetts General Laws Chapter 111, Section 70G.
    • The member's personal and/or family cancer history suggests that an inherited pathogenic/likely pathogenic variant in BRCA1, BRCA2, or PALB2 may exist by meeting the criteria for Category I, II, III, or IV.

    Category I: Family with a Known BRCA1, BRCA2, or PALB2 Variant

    MassHealth covers BRCA1, BRCA2, and PALB2 genetic testing for susceptibility to breast or ovarian cancer in unaffected adults when all of the following are met:

    ALL of the following

    • The member is an unaffected adult.
    • The member has a first- or second-degree biological relative with a known BRCA1, BRCA2, or PALB2 pathogenic/likely pathogenic variant.
    • Testing is performed by single-site analysis for the known familial variant.
    • A recommendation for testing has been confirmed.
    • The member has received appropriate genetic counseling.
    • Documentation of the known familial variant is provided.

    Category II: Individuals with Active Cancer or a Personal History of Cancer

    Genetic testing for BRCA1, BRCA2, and PALB2 variants, including large genomic rearrangement testing (i.e., BART), may be considered medically necessary when all prerequisite conditions are met and any one of the qualifying criteria below is met.

    ALL prerequisites

    • The member has active cancer or a personal history of cancer.
    • The BRCA variant status is unknown.
    • The member has received appropriate genetic counseling.

    • ANY one of the following

      • A. Personal history of breast cancer and one or more qualifying factors

        • The member has a personal history of breast cancer.

    Category III: Individuals Without a Personal History of BRCA-Related Cancers

    Testing of an individual without a cancer diagnosis should be considered only when an appropriate family member is unavailable for testing. Genetic testing for BRCA1, BRCA2, and PALB2 variants, including large genomic rearrangement testing (i.e., BART), may be considered medically necessary when all of the following are met.

    ALL of the following

    • The member has no personal history of breast, ovarian, pancreatic, or prostate cancer.
    • An appropriate family member is unavailable for testing.
    • The treating provider has documented genetic counseling.
    • The treating provider has determined that the member is at high risk for a BRCA1, BRCA2, or PALB2 variant using a prior probability model, such as a validated quantitative risk assessment tool endorsed by the U.S. Preventive Services Task Force (USPSTF).

    Category IV: Adults Considering Treatment with a PARP Inhibitor

    Refer to the MassHealth Drug List website for prior-authorization criteria for PARP inhibitors, including Lynparza (olaparib), Rubraca (rucaparib), and Talzenna (talazoparib).

    Adults considering treatment with a PARP inhibitor must meet the applicable separate MassHealth Drug List prior-authorization criteria.

    MassHealth considers BRCA and PALB2 testing experimental and investigational for all other indications, including testing in men for surveillance; screening for breast or epithelial ovarian cancers; and assessment of risk for other cancers, such as colon cancer, because effectiveness for these indications has not been established.

    Genetic testing for BRCA-related cancer is not recommended for children because no risk-reduction strategies for children exist and the risk of developing a cancer associated with a BRCA1, BRCA2, or PALB2 pathogenic/likely pathogenic variant during childhood is extremely low.

    Genetic testing is not medically necessary when it is performed primarily for the medical management of a family member.

    Testing is not medically necessary when the only indication is family history and clinical judgment indicates that the member does not have a reasonable likelihood of having a BRCA1, BRCA2, or PALB2 pathogenic/likely pathogenic variant, considering the member's current age and the age of unaffected female relatives who link the member with the affected relatives.

    Testing is not medically necessary when the member has been previously tested.

    Coding and Clinical Definitions Used in Criteria

    CPT Codes for BRCA testingCPT
    81162BRCA1, BRCA2 gene analysis; full sequence analysis and full duplication/deletion analysis
    81163BRCA1, BRCA2 gene analysis; full sequence analysis
    81164BRCA1, BRCA2 gene analysis; full duplication/deletion
    81165BRCA1 gene analysis; full sequence analysis
    81166BRCA1 gene analysis; full duplication/deletion analysis, including detection of large gene rearrangements
    81167BRCA2 gene analysis; full duplication/deletion analysis, including detection of large gene rearrangements
    81212BRCA1, BRCA2 gene analysis for Ashkenazi Jewish descent founder mutations: 185delAG, 5385insC, 6174delT
    81215BRCA1 gene analysis; known familial variant
    81216BRCA2 gene analysis; full sequence analysis
    81217BRCA2 gene analysis; known familial variant
    1–10 of 11
    1/2
    PALB2 testing descriptionsCPT
    PALB2PALB2 gene analysis; full gene sequence
    PALB2PALB2 gene analysis; known familial variant
    High-grade prostate cancer
    DefinitionHigh-grade prostate cancer is defined as a Gleason score of 7 or greater.
    Family-history relevanceA close blood relative with high-grade prostate cancer may qualify as a supporting family-history feature.
    Related qualifying diseaseMetastatic or node-positive prostate cancer is also a qualifying personal-history pathway.
    Early-onset breast cancer
    Age thresholdBreast cancer diagnosed at age 50 years or younger meets the early-onset criterion.
    Applicable historyThe criterion applies to a personal history of breast cancer.

    Prior Authorization and Documentation Requirements

    Prior Authorization

    Prior Authorization Required

    Submit a prior authorization (PA) request for BRCA-related genetic testing. Include all clinical documentation supporting medical necessity; electronic submission through the Provider Online Service Center (POSC) is required unless an approved electronic claims waiver applies.

    • If submitting under an approved waiver, include the MassHealth PA-1 Form and all supporting documentation.
    Documentation Required

    Written Consent Required

    Obtain the member’s prior written consent for genetic testing in accordance with Massachusetts General Laws Chapter 111, Section 70G.

    Documentation Required

    Clinical Background

    BRCA-related hereditary cancer is associated primarily with germline pathogenic or likely pathogenic variants in BRCA1 or BRCA2; PALB2 is also implicated in hereditary breast cancer. These inherited variants are associated with increased risks for breast, ovarian, fallopian tube, peritoneal, male breast, pancreatic, testicular, and early-onset prostate cancers. Genetic testing is intended to identify inherited risk when the result will affect clinical management, and MassHealth evaluates coverage on a case-by-case basis.

    Definitions

    Close blood relatives
    Degree categoriesClose blood relatives include first-, second-, and third-degree biological relatives.
    Family relationshipFirst-degree relatives include parents, siblings, and children; second-degree relatives include half-siblings, aunts, uncles, grandparents, grandchildren, and nieces or nephews.
    Third-degree relativesThird-degree relatives include first cousins, great-aunts, great-uncles, great-grandchildren, and great-grandparents.
    High-grade prostate cancer
    ThresholdHigh-grade prostate cancer means a Gleason score of 7 or greater.
    Scoring systemThe definition is based on the prostate cancer Gleason score.

    Covered Testing Indications

    Unaffected adult with a known familial BRCA1, BRCA2, or PALB2 variant

    Covered when ALL of the following are met:

    Known familial variant: The unaffected adult has a first- or second-degree biological relative with a known BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant; a recommendation for testing is confirmed; appropriate genetic counseling has occurred; and single-site analysis for the known familial variant is requested.First- or second-degree biological relative

    Documentation of the known familial variant and the relationship of the carrier to the member is required.

    Cancer-affected individual with unknown variant status

    Covered when ALL of the cancer-status prerequisites are met and ANY one qualifying pathway applies:

    Cancer-affected individual requirements

    • Cancer-status prerequisites:

    Eligibility Requirements

    For purposes of eligibility, close blood relatives are first-, second-, or third-degree biological relatives on the same side of the family. First-degree relatives include parents, siblings, and children; second-degree relatives include half-siblings, aunts, uncles, grandparents, grandchildren, and nieces or nephews; and third-degree relatives include first cousins, great-aunts, great-uncles, great-grandchildren, and great-grandparents. Category I applies to an unaffected adult with a first- or second-degree biological relative who has a known BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant. The familial variant and the carrier’s relationship to the member must be documented, and testing must be limited to single-site analysis for the known familial variant with appropriate genetic counseling.

    Documentation requirements vary by eligibility category. For Category I, submit documentation of the known familial BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant and the carrier’s relationship to the member. For Category II tumor-profiling indications, a BRCA1, BRCA2, PALB2, or other pathogenic or likely pathogenic variant must have been identified by tumor profiling, and germline pathogenic or likely pathogenic variant analysis must not have been performed previously. Category II requests also require an active or personal history of cancer, unknown BRCA variant status, and appropriate genetic counseling. Category III requests require documentation that an appropriate affected family member is unavailable for testing, a validated quantitative risk assessment identifies high risk for a BRCA/PALB2 variant, appropriate genetic counseling has occurred, and a three-generation pedigree documents affected family members.

    Not Covered and Experimental Indications

    The following indications are not covered because MassHealth considers BRCA and PALB2 testing experimental and investigational for them: testing men for surveillance; screening for breast or epithelial ovarian cancers; and assessing risk for other cancers, such as colon cancer.

    Policy Summary
    PayerMassachusetts Executive Office of Health and Human Services
    PolicyGuidelines for Medical Necessity Determination for Genetic Testing for BRCA-related Breast and/or Ovarian Cancer
    Policy CodePolicy MNG-GT-BRCA_2025-06
    Change TypeRevisionno material clinical or coverage change
    Effective DateJun 25, 2025
    Next Review DateN/A
    Key ActionSubmit the prior authorization request and all supporting documentation electronically through the Provider Online Service Center.
    SourceLink
    On This Page
    Coverage CriteriaCoding and Clinical Definitions Used in CriteriaPrior Authorization and Documentation RequirementsClinical BackgroundDefinitionsCovered Testing IndicationsEligibility RequirementsNot Covered and Experimental Indications
    Documentation of the relationship of the carrier to the member is provided.

  1. ONE or more

    • Diagnosed at age 50 years or younger.

    • ALL of the following

      • Diagnosed at any age.

      • ONE or more

        • Multiple primary breast cancers, at any age.
        • Lobular breast cancer with a personal or family history of diffuse gastric cancer.
        • Triple-negative breast cancer (ER-, PR-, HER2-).
        • Testing is required to aid a systemic treatment decision: PARP inhibitors for metastatic breast cancer or adjuvant olaparib for high-risk, HER2-negative breast cancer.
        • Unknown or limited family history, defined as fewer than two known first- or second-degree female relatives or female relatives surviving beyond 45 years of age on either or both sides of the family, such as a member who is adopted.
        • Ashkenazi Jewish ancestry.

    • ALL of the following

      • Diagnosed at any age.
      • Family history of one or more close blood relatives on the same side of the family with any of the following: female breast cancer diagnosed at age 50 years or younger; ovarian cancer; pancreatic cancer; metastatic or high- or very-high-risk prostate cancer; or male breast cancer.

    • ALL of the following

      • Diagnosed at any age.
      • Three or more diagnoses of breast and/or prostate cancer, of any grade, on the same side of the family, including the member with breast cancer.

    • ALL of the following

      • Diagnosed at any age.
      • Ashkenazi Jewish ancestry.

  2. B. Personal history of prostate cancer

    • Personal history of any-grade prostate cancer diagnosed at any age.

    • ONE or more

      • Ashkenazi Jewish ancestry.
      • One or more close blood relatives with ovarian cancer, pancreatic cancer, breast cancer diagnosed before age 50, or high-grade prostate cancer.
      • Three or more close blood relatives with breast and/or prostate cancer, of any grade, at any age, on the same side of the family.
  3. C. Personal history of male breast cancer.
  4. D. Personal history of ovarian cancer.
  5. E. Personal history of exocrine pancreatic cancer.
  6. F. Personal history of metastatic (Stage IVB) or node-positive prostate cancer.
  7. G. A BRCA1, BRCA2, PALB2, or other pathogenic/likely pathogenic variant detected by tumor profiling on any tumor type, in the absence of germline pathogenic/likely pathogenic variant analysis.
    8. Other qualifying featuresMultiple primary breast cancers, triple-negative breast cancer, and an unknown or limited family history are additional qualifying features when applicable.
    Limited family history
    Relative countLimited family history means fewer than two known first-degree or second-degree female relatives.
    Survival thresholdThe criterion also applies when female relatives have not survived beyond 45 years of age.
    Family sideThe assessment applies on either or both sides of the family.
    Breast/prostate cancer family clustering
    Minimum diagnosesThere must be three or more diagnoses of breast and/or prostate cancer.
    Family sideThe diagnoses must occur on the same side of the family.
    Member includedThe member is included in the count when applicable, including a member with breast cancer.
    Metastatic or node-positive prostate cancer
    Metastatic diseaseMetastatic prostate cancer means Stage IVB disease.
    Nodal diseaseNode-positive prostate cancer qualifies as an alternative to metastatic disease.
    Personal-history pathwayA personal history of metastatic Stage IVB or node-positive prostate cancer is a qualifying pathway.

    Document Clinical History and Test Specification

    Document the member’s personal and/or family cancer history, risk factors, and supporting rationale for the requested test. Alternatively, submit a completed BRCA or PALB2 test request form identifying the exact genes and/or variants, signed and dated by the ordering physician.

    Documentation Required

    Provide a Clinical Utility Rationale

    Explain how the genetic test results will guide clinical decisions that would not otherwise be made without testing. Testing is not medically necessary when results will provide no added value in the member’s clinical management.

    Documentation Required

    Category III Supporting Documentation

    For Category III coverage, submit the documentation used to establish the member’s risk, including the validated quantitative risk assessment tool, the positive responses that produced the score, applicable guidelines and risk factors, and a three-generation pedigree documenting affected family members.

    • Include the validated quantitative risk assessment tool used.
    • Provide the member’s positive scoring responses and/or the guidelines and risk factors used to determine risk.
    • Submit a three-generation pedigree with documentation of affected family members.
    Documentation Required

    Category IV Supporting Documentation

    For Category IV coverage, document the relevant diagnosis, hormone-receptor status, prior and current treatment, and the rationale for testing to inform treatment decisions.

    Documentation Required

    Laboratory-Submitted Clinical Information

    Ensure that the clinical information supporting the request is submitted by the clinical laboratory performing the genetic testing.

    Denial Risk

    Core Medical-Necessity Requirements

    Confirm that all core medical-necessity requirements are met before requesting testing. MassHealth covers BRCA-related genetic testing once per lifetime when the member meets the applicable criteria.

    • Member is 18 years of age or older.
    • Testing results will be clinically useful and provide added value in clinical management.
    • Prior written consent has been obtained.
    • Personal and/or family cancer history supports eligibility under Category I, II, III, or IV.
    • Testing may be denied when the member is under age 18, testing provides no added clinical value, or prior written consent is absent.
    Denial Risk

    Non-Medically Necessary Circumstances

    Do not request coverage when testing is primarily for management of a family member, when family history alone does not establish a reasonable likelihood of a BRCA/PALB2 pathogenic or likely pathogenic variant, or when the member has been previously tested.

    • Consider the member’s current age and the ages of unaffected female relatives who link the member to affected relatives when evaluating family-history-only requests.
    Denial Risk

    Excluded Indications

    BRCA and PALB2 testing is experimental and investigational for other indications for which effectiveness has not been established.

    • Testing in men for surveillance.
    • Screening for breast or epithelial ovarian cancers.
    • Assessment of risk for other cancers, such as colon cancer.
    Documentation Required

    Provide Genetic Counseling

    For members qualifying under Categories I or II, provide or arrange the required genetic counseling before testing and document that counseling in the clinical record and PA submission.

    • Document the counseling provided, including the member’s understanding of the purpose, potential results, implications, and limitations of testing.
    Documentation Required

    Complete and Authenticate the Test Order

    Document the member’s personal and family history, risk factors, and rationale for testing in the clinical record. If using the test order as supporting documentation, ensure it identifies the exact gene(s) and/or variant(s) requested and is signed and dated by the ordering physician.

    Policy terminologyA Gleason score of 7 or greater is the policy threshold for high-grade prostate cancer.
    Breast cancer
    Invasive diseaseBreast cancer includes invasive breast cancer.
    In situ diseaseBreast cancer also includes ductal carcinoma in situ (DCIS).
    ScopeBoth invasive breast cancer and DCIS are included in the policy definition.
    Ovarian carcinoma
    Fallopian tube cancerOvarian carcinoma includes fallopian tube cancers.
    Primary peritoneal cancerOvarian carcinoma includes primary peritoneal cancers.
    Ovarian histologyEpithelial, non-mucinous ovarian cancers are associated with the BRCA gene.
    The member has active cancer or a personal history of cancer; BRCA variant status is unknown; and appropriate genetic counseling has occurred.

  8. Qualifying personal, family, or tumor pathway

    • Breast cancer history: The member has a personal history of breast cancer and meets at least one qualifying feature: diagnosis at age 50 years or younger; multiple primary breast cancers; lobular breast cancer with a personal or family history of diffuse gastric cancer; triple-negative breast cancer; testing needed for PARP-inhibitor treatment of metastatic breast cancer or adjuvant olaparib for high-risk, HER2-negative breast cancer; unknown or limited family history; Ashkenazi Jewish ancestry; or qualifying family history.

      Qualifying family history includes close blood relatives with specified breast, ovarian, pancreatic, prostate, or male breast cancers, or three or more breast and/or prostate cancer diagnoses on the same side of the family including the member.

    • Prostate cancer history: The member has a personal history of any-grade prostate cancer with Ashkenazi Jewish ancestry; one or more close blood relatives with ovarian cancer, pancreatic cancer, breast cancer diagnosed before age 50, or high-grade prostate cancer; or three or more close blood relatives with breast and/or prostate cancer on the same side of the family.High-grade prostate cancer: Gleason score ≥7

    • Other qualifying personal cancer history

      • Personal history of male breast cancer.
      • Personal history of ovarian cancer, including fallopian tube or primary peritoneal cancer.
      • Personal history of exocrine pancreatic cancer.
      • Personal history of metastatic Stage IVB or node-positive prostate cancer.
    • Tumor-profiling pathway: A BRCA1, BRCA2, PALB2, or other pathogenic or likely pathogenic variant is detected by tumor profiling on any tumor type, and germline pathogenic or likely pathogenic variant analysis has not been performed.Tumor finding plus no prior germline analysis

    9. Unaffected individual with unavailable affected relative and high modeled risk

    Covered when ALL of the following are met:

    Unaffected individual with high inherited risk: The individual has no personal history of breast, ovarian, pancreatic, or prostate cancer; an appropriate affected family member is unavailable for testing; the treating provider has documented genetic counseling; and a validated quantitative prior-probability model or risk-assessment tool endorsed by the U.S. Preventive Services Task Force determines that the individual is at high risk for a BRCA/PALB2 variant.High risk by validated quantitative model

    Submit documentation of the risk assessment and high-risk determination. Testing may include BRCA1, BRCA2, PALB2, and large genomic rearrangement testing such as BART.

    Adult considering PARP-inhibitor treatment

    For an adult considering PARP-inhibitor treatment, follow the separate MassHealth Drug List prior-authorization criteria:

    Relevant PARP inhibitor: The adult is considering treatment with Lynparza (olaparib), Rubraca (rucaparib), or Talzenna (talazoparib).Treatment-specific criteria apply

    Refer to the MassHealth Drug List website for the applicable prior-authorization criteria.