Aetna BRCA and Risk‑Reducing Surgery Coverage Update

Coverage Criteria and Medical Necessity

Prophylactic Mastectomy - Medical Necessity

Covered when ANY of the following are met:

Prophylactic mastectomy indications: 1. Women diagnosed with breast cancer at 45 years of age or younger; OR 2. Women who are at increased risk for specific mutation(s) due to ethnic background (eg, Ashkenazi Jewish) with one or more relatives with breast cancer or epithelial ovarian cancer at any age; OR 3. Women who carry a germline genetic mutation in CDH1, TP53, PTEN, or PALB2; OR 4. Women who possess BRCA1 or BRCA2 mutations confirmed by molecular testing; OR 5. Women who received chest radiation between ages 10 and 30; OR 6. Women with a first- or second-degree male relative with breast cancer (note: prophylactic removal of contralateral breast tissue is considered medically necessary in men with breast cancer); OR 7. Women with multiple primary or bilateral breast cancers in a first- or second-degree blood relative; OR 8. Women with multiple primary or bilateral breast cancers themselves; OR 9. Women with one or more cases of epithelial ovarian cancer and one or more first- or second-degree blood relatives on the same side of the family with breast cancer; OR 10. Women with three or more affected first- or second-degree blood relatives on the same side of the family, irrespective of age at diagnosis; OR 11. Women with atypical hyperplasia (lobular or ductal) and/or lobular carcinoma in situ (LCIS) confirmed on biopsy with dense, fibronodular breasts that are mammographically or clinically difficult to evaluate.

Prophylactic Bilateral Oophorectomy - Medical Necessity

Covered when ANY of the following are met for women with risk factors for epithelial ovarian carcinoma:

Prophylactic bilateral oophorectomy indications: 1. Women beyond child-bearing age (age 40 or older) diagnosed with an hereditary epithelial ovarian cancer syndrome based on a family pedigree constructed by a genetic counselor or qualified physician demonstrating autosomal dominant inheritance; OR 2. Women with two first-degree relatives with a history of epithelial ovarian cancer; OR 3. Women with a personal history of breast cancer and at least one first-degree relative with epithelial ovarian cancer; OR 4. Women with confirmed BRCA1 or BRCA2 germline mutations; OR 5. Women who carry germline mutations in BRIP1, RAD51C, RAD51D, MLH1 or MSH2; OR 6. Women with one first-degree relative and one or more second-degree relatives with epithelial ovarian cancer.

Multigene Panel Testing for Moderate to High Penetrance Genes

Germline multigene panel testing is medically necessary when ALL of the following apply:

Multigene panel testing criteria: Panel must include BRCA1, BRCA2, CDH1, MLH1, MSH2, MSH6, PALB2, PTEN, STK11, TP53 and full duplication/deletion analysis (including BRCA1/2, MLH1, MSH2, STK11); AND testing is performed once per lifetime; AND the person meets one or more NCCN testing criteria for high-penetrance breast cancer susceptibility genes (eg, NCCN CRIT-2,4,5,6).

Experimental / Investigational

Experimental and investigational (not covered) indications:

Experimental/Investigational: 1. Elective salpingectomy for ovarian cancer prevention in low hereditary-risk women due to insufficient evidence of effectiveness; OR 2. Prophylactic mastectomy for men with BRCA mutations or family history of breast cancer because clinical data and guideline support are lacking.

Genetic testing coverage criteria

Covered when documentation and criteria are met

Prior authorization and documentation: Aetna Breast and Ovarian Cancer Susceptibility Gene Testing Prior Authorization Form must be completed and submitted with the laboratory test requisition before testing; documentation should include specific cancer diagnosis in the proband(s), pertinent medical records, a formal 3-generation pedigree, and a summary explaining how testing will change the member's immediate medical care.

Prior authorization required before testing.

Clinical indication for testing: Individual meets high-risk criteria based on family history or validated risk assessment tools (pre-test probability >25%), or there is a known familial BRCA mutation permitting mutation-specific testing; testing may be indicated for men with breast cancer when results influence female relatives' management.Pre-test probability >25% denotes high-risk

Testing type selection: Use a mutation-specific assay when a familial mutation is known; for persons of Ashkenazi Jewish descent, begin with the 3-founder-mutation panel and proceed to full sequencing if negative but other high-risk features are present; full gene sequencing and duplication/deletion analysis are used when indicated.

Risk-reducing surgery — indications

Covered when ALL of the following are met

RRSO/prophylactic oophorectomy for high-risk women: Patient is from a family with hereditary ovarian cancer syndrome or has a documented BRCA1 or BRCA2 mutation; procedure is performed after completion of childbearing or by age 35–40 at the latest; benefits and risks (including potential need for lifelong hormone therapy) have been discussed and documented.age >=35-40 or childbearing complete

Supported by cohort and meta-analysis data showing substantial reductions in ovarian and breast cancer risk and mortality.

Prophylactic mastectomy for high-risk women: Patient has a demonstrated BRCA1/2 mutation or a lifetime risk in excess of 25–30% and has received counseling about risks/benefits and surgical options; counseling and documentation include discussion of reconstruction and nipple/skin-sparing considerations.lifetime risk >25%

Limited indications — atypia

Not routinely covered / Not indicated when

Atypical hyperplasia alone: Atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), or LCIS alone is generally not an indication for prophylactic mastectomy; surveillance and chemoprevention are preferred and prophylactic surgery is not routinely recommended in absence of other high-risk factors.

Risk-reducing salpingo-oophorectomy (RRSO)

Evidence-based coverage-relevant findings summarized:

RRSO benefits summary: In BRCA1/2 mutation carriers, risk-reducing salpingo-oophorectomy (RRSO) is associated with reduced risk of ovarian and fallopian tube cancer, reduced risk of first-diagnosis breast cancer (by mutation type), and reductions in all-cause and cancer-specific mortality based on prospective cohort and meta-analysis data.

Elective/opportunistic salpingectomy

Stance on salpingectomy as a preventive strategy:

Salpingectomy evidence and stance: Opportunistic salpingectomy may be discussed as a preventive option at the time of hysterectomy or sterilization in average-risk women, but salpingectomy alone is not proven to reduce ovarian cancer risk in BRCA mutation carriers and is discouraged outside clinical trials; NCCN and professional statements do not endorse salpingectomy alone as the standard risk-reducing procedure for BRCA carriers.

Multigene panel testing — Interpretation and limitations of multigene panel testing

Interpretation and limitations of multigene panel testing:

Multigene panel testing considerations: Multigene panels increase diagnostic yield beyond BRCA1/2 but include moderate- and low-penetrance genes with uncertain clinical validity; panels increase detection of variants of uncertain significance (VUS) and may identify incidental germline findings from tumor sequencing; management implications for many moderate-risk genes are unclear and results require genetic counseling and expert interpretation.

Studies report pooled ORs >2.6 for protein-truncating variants in certain genes; actionable mutation frequencies are low for many non-BRCA genes.

A unilateral oophorectomy performed incidentally at the time of a hysterectomy when both ovaries remain in place is considered not medically necessary under generally accepted guidelines and this policy. This exclusion aligns with the policy statement that prophylactic oophorectomy as a sole procedure is not indicated for women without a BRCA mutation or relevant family history, and decisions about concurrent hysterectomy/oophorectomy should be individualized based on hereditary syndrome status and the patient's preferences regarding hormone therapy and morbidity.

This policy addresses breast and ovarian cancer susceptibility in the context of hereditary risk. For individuals meeting the policy’s high-risk criteria (for example, documented BRCA1/2 mutation or a pedigree consistent with hereditary ovarian cancer), prophylactic bilateral oophorectomy/salpingo-oophorectomy may be medically necessary as specified elsewhere in the coverage criteria; the unilateral procedure described above does not meet those indications.

Direct-to-consumer BRCA tests such as the FDA-authorized 23andMe report only three specific BRCA1/BRCA2 founder variants (most relevant to Ashkenazi Jewish ancestry) and therefore detect only three of >1,000 known BRCA mutations. The policy cautions that these DTC results should not be used to make treatment decisions, including consideration of prophylactic surgery, without confirmatory clinical testing and genetic counseling.

Confirmatory clinical testing (and genetic counseling) is required before using a BRCA-related test result to guide management because a negative DTC result does not exclude the possibility of other pathogenic BRCA variants; multigene panel or full sequencing may be indicated when NCCN testing criteria are met.

Certain ICD-10 diagnoses and clinical conditions are explicitly excluded from coverage for the indications in this policy. Examples called out include a broad set of malignant neoplasms outside the scope of breast/ovary/pancreas/retroperitoneum/fallopian tube cancers, and specific non-indicated breast conditions such as diffuse cystic mastopathy (fibrocystic disease), which is not covered as an indication for prophylactic mastectomy.

The policy also excludes coverage for genetic testing when performed solely for procreative management in males without an appropriate cancer diagnosis (ICD-10 Z31.448) and lists the ICD-10 codes that are covered only when selection criteria are met versus those that are not covered for the policy’s listed indications.

Subcutaneous (nipple/areola-preserving) mastectomy is generally not indicated for cancer prevention because surgical techniques that preserve the nipple-areolar complex leave residual breast epithelium (approximately 10–20%) beneath the areola. The American College of Medical Genetics and related guidance conclude that when the goal is maximal risk reduction, total mastectomy (including nipple removal) removes more breast epithelium than subcutaneous techniques.

Prophylactic oophorectomy is supported by this policy only for women who meet the specified high-risk criteria (for example, documented BRCA1/2 mutation or family pedigree consistent with hereditary epithelial ovarian cancer); it is not indicated as a routine concurrent procedure for women without BRCA mutations or a family history of ovarian cancer, and the decision to perform hysterectomy with oophorectomy should be individualized.

Salpingectomy performed alone (without oophorectomy) is not the standard of care for risk reduction in BRCA mutation carriers and is discouraged outside of clinical trials. While opportunistic salpingectomy at the time of hysterectomy or sterilization may be discussed for average-risk women, current guideline statements (including NCCN and SGO commentary) indicate that salpingectomy alone has not been proven to reduce ovarian cancer risk in high-risk women and therefore should not replace risk-reducing salpingo-oophorectomy for BRCA carriers until supportive prospective data are available.

For BRCA carriers who wish to defer oophorectomy, the policy recommends against salpingectomy without oophorectomy until randomized or prospective trial evidence demonstrates it as an effective risk-reducing option.

The guideline and evidence review excerpts cited in this policy (UpToDate reviews and the NCCN ovarian cancer guideline versions referenced) do not mention routine testing for BARD1 or RAD51D as standard practice. The absence of guideline recommendation is noted in the policy’s discussion of testing utility and informs coverage considerations.

As a result, routine inclusion of BARD1 and RAD51D testing outside of situations meeting the policy’s criteria or established guideline recommendations is not supported by the cited guideline summaries.

Prophylactic mastectomy is considered experimental and investigational (not covered) for indications other than those specifically listed in the policy. Examples of non-covered indications include conditions such as diabetic mastopathy, fibrocystic breast disease, and pseudo-angiomatous stromal hyperplasia (PASH) because the clinical effectiveness of prophylactic mastectomy for these indications has not been established.

When prophylactic mastectomy is being considered, the policy requires that the patient meet one or more of the defined medical necessity criteria (e.g., early-onset breast cancer, documented high-penetrance pathogenic variant, or family history patterns specified in the coverage criteria).

The policy explicitly excludes prophylactic mastectomy for diffuse cystic mastopathy (fibrocystic disease); such presentations are not considered appropriate indications for risk-reducing mastectomy. Similarly, genetic testing ordered solely for procreative management of males without an appropriate cancer diagnosis is not covered under the conditions listed in this policy.

Coverage for surgical or genetic interventions requires documentation that the member meets the policy’s specific clinical criteria; absent those indications, procedures and testing related to procreative management or benign diffuse breast changes are not supported.

Subcutaneous (nipple-conserving) mastectomy is not considered an effective prophylactic operation for risk reduction because residual breast epithelium remains under the areola after this technique (approximately 10–20%). For maximal epithelial removal and cancer risk reduction, total mastectomy including nipple removal removes more breast tissue than subcutaneous approaches, and the policy reflects this limitation in considering techniques acceptable for prophylactic indication.

When nipple-sparing approaches are considered for BRCA1/2 carriers, multidisciplinary evaluation and counseling are recommended, and documentation of the discussion of risks, benefits and reconstruction options is expected.

For BRCA mutation carriers, salpingectomy without oophorectomy is not recommended as an effective risk-reducing procedure until randomized or prospective data demonstrate benefit. NCCN guidance and the SGO/UpToDate discussions cited in this policy note that salpingectomy alone does not eliminate ovarian cancer risk and therefore is discouraged as a substitute for bilateral salpingo-oophorectomy in high-risk women outside of clinical trials.

The policy supports bilateral salpingo-oophorectomy (RRSO) as the evidence-based risk-reducing operation for BRCA carriers and reserves salpingectomy-alone approaches for investigational contexts or average-risk opportunistic scenarios per guideline language.

Available evidence is insufficient to determine that CHEK2 mutation testing improves health outcomes. Although CHEK2 truncating and particular missense variants are associated with a moderate increase in breast cancer risk (approximately 2–5x), risk estimates are uncertain and clinical management recommendations for moderate-penetrance mutations are not standardized.

Because of these uncertainties, the policy indicates that testing for CHEK2 is of limited, context-dependent clinical utility and that well-designed studies are needed to determine whether CHEK2 testing leads to management changes that improve outcomes.

No content specified for this block.

Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and do not constitute offers of coverage or medical advice. They provide a general description of plan or program benefits and are not contracts; treating providers remain responsible for medical advice and patient care, and policy content may be updated.

Billing and Coding

Covered CPT/HCPCS codes if selection criteria metmixedCovered

0037U	Targeted genomic sequence analysis, solid organ neoplasm, DNA analysis of 324 genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability and tumor mutational burden [FoundationOne CDx].
0102U	Hereditary breast cancer-related disorders genomic sequence analysis panel (17 genes).
+0131U	Targeted mRNA sequence analysis panel (13 genes) (List separately).
+0135U	Hereditary gynecological cancer targeted mRNA sequence analysis panel (12 genes) (List separately).
0172U	Somatic mutation analysis of BRCA1 and BRCA2 and homologous recombination deficiency pathways with tumor genomic instability score.
19301	Mastectomy, partial (eg, lumpectomy, tylectomy, quadrantectomy, segmentectomy).
19303	Mastectomy, simple, complete.
58150	Hysterectomy procedures (general listing).
58294	Hysterectomy procedures (alternate listing).
58541-58554	Laparoscopy, surgical, with hysterectomy.

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CPT codes not covered for indications listed in the CPBmixedNot Covered

0103U	Hereditary ovarian cancer genomic sequence analysis panel (24 genes) - CPT code not covered for indications listed in this CPB.
0129U	Genomic sequence and deletion/duplication analysis panel (listed among codes not covered for some indications).

Applicable molecular CPT codesCPT

81294	MLH1 full sequence analysis
81295	MSH2 full sequence analysis
81297	MSH2 duplication/deletion variants
81298	MSH6 full sequence analysis
81300	MSH6 duplication/deletion variants
81301	Microsatellite instability analysis
81310	NPM1 exon 12 variants
81315	PML/RARalpha translocation analysis
81317	PMS2 full sequence analysis
81319	PMS2 duplication/deletion variants

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Relevant HCPCS/J-codes mentionedHCPCS

J9045	Talazoparib (Talzenna) — no specific code listed.
J9060	Injection, cisplatin, powder or solution, 10 mg.
J9258	Injection, paclitaxel protein-bound particles (teva), 1 mg.
J9259	Injection, paclitaxel protein-bound particles (american regent), 1 mg.
J9263	Injection, oxaliplatin, 0.5 mg.
J9264	Injection, paclitaxel protein-bound particles, 1 mg.

Covered ICD-10 codes when selection criteria are metICD-10Covered

C25.0-C25.9	Malignant neoplasm of pancreas
C48.0-C48.8	Malignant neoplasm of retroperitoneum and peritoneum
C50.011-C50.929	Malignant neoplasm of breast
C56.1-C56.9	Malignant neoplasm of the ovary
C57.00-C57.02	Malignant neoplasm of fallopian tube
C61	Malignant neoplasm of prostate
D05.00-D05.92	Carcinoma in situ of breast
D24.1-D24.9	Benign neoplasm of breast
N60.91-N60.99	Unspecified benign mammary dysplasia
Z15.01	Genetic susceptibility to malignant neoplasm of breast

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ICD-10 codes not covered for listed indicationsICD-10Not Covered

C00.1-C24.9, C26.0-C47.9, C49.0-C49.9, C51.0-C55, C57.10-C60.9, C62.00-D09.9	Malignant neoplasms not covered for indications listed in the CPB
N60.11-N60.19	Diffuse cystic mastopathy (not covered for prophylactic mastectomy)
Z31.448	Encounter for other genetic testing of male for procreative management (not covered without diagnosis of breast or prostate cancer)

Prophylactic breast reconstruction CPT codes covered if criteria metCPTCovered

19350	Nipple/areola reconstruction
19357	Breast reconstruction with tissue expander
19361	Breast reconstruction with latissimus dorsi flap
19364	Breast reconstruction with free flap
19366	Breast reconstruction with other technique
19367	TRAM flap, single pedicle
19368	TRAM flap with microvascular anastomosis
19369	TRAM flap, double pedicle

inv-32: Age for prophylactic oophorectomy consideration — 40 years or older

Age threshold40 years or older

ContextConsidered for women beyond child-bearing age or when indicated by hereditary epithelial ovarian cancer syndrome pedigree

Procedure referencedProphylactic bilateral oophorectomy/salpingo-oophorectomy (RRSO)

inv-33: Age at breast cancer diagnosis threshold for prophylactic mastectomy consideration — 45 years or younger

Age at breast cancer diagnosis45 years or younger

Provider Requirements, Prior Authorization, and Documentation

Note

Coverage Contingent on Policy Criteria

Coverage of the listed CPT/HCPCS codes is contingent on meeting the medical necessity and selection criteria described in this policy. Providers should ensure that testing or surgery is supported by the clinical criteria before submitting claims.

Applicable codes are covered only when policy selection/medical necessity criteria are met.

Prior Authorization

Prior Authorization Required for Molecular Testing

Prior authorization (precertification) is required for molecular breast and ovarian cancer susceptibility gene testing. Submit the Aetna Breast and Ovarian Cancer Susceptibility Gene Testing Prior Authorization Form together with the laboratory's test requisition and required documentation before the specimen is tested.

Send the Aetna Prior Authorization Form with the laboratory test requisition.
Do not have the laboratory perform testing until Aetna confirms coverage/precertification.
Documentation of specific cancer diagnosis in the proband(s) and a summary of how testing will change immediate medical care may be required.

Genes, Panels, and Testing Requirements

inv-78: Core genes required/mentioned for panels — BRCA1, BRCA2, CDH1, PALB2, TP53, PTEN, MLH1, MSH2, MSH6, STK11

Core genes (required in panel)BRCA1, BRCA2, CDH1, PALB2, TP53, PTEN, MLH1, MSH2, MSH6, STK11

Panel requirement notePanel must include full duplication/deletion analysis for specified genes (BRCA1/2, MLH1, MSH2, STK11)

Frequency of inclusionMultigene panel testing must include these genes to qualify for coverage

inv-79: BRCA1/BRCA2 — >25% pre-test probability for high-risk testing consideration; known familial mutation supports single-site testing

High-risk testing consideration>25% pre-test probability for BRCA1/BRCA2

Familial mutation optionKnown familial BRCA mutation supports single-site (mutation-specific) testing

Clinical Guidance, Background, and Limitations

Subcutaneous mastectomy is generally not recommended for cancer prevention because residual breast epithelium remains under the nipple-areolar complex; when maximal tissue removal is desired for risk reduction, total mastectomy including removal of the nipple is the operation that removes the most breast epithelium.

Prophylactic oophorectomy as a sole procedure is not indicated for women without BRCA mutations or a family history of epithelial ovarian cancer; decisions about prophylactic oophorectomy performed with other procedures should consider the individual's hereditary risk, need for lifelong hormone therapy, and personal preferences.

The policy follows guideline-origin statements that salpingectomy alone is not standard of care for BRCA mutation carriers and is discouraged outside clinical trials. While opportunistic salpingectomy may be discussed in average-risk women undergoing pelvic surgery, for high-risk women the evidence supporting salpingectomy without oophorectomy is insufficient and not recommended as a substitute for RRSO.

Cited UpToDate reviews and the NCCN ovarian cancer guideline versions referenced do not include routine recommendation for testing of BARD1 or RAD51D. The policy notes the absence of guideline support for routine testing of these genes in the contexts covered.

Note

BRCA1/2 status may affect therapy sensitivity (informational)

BRCA1/2 mutation status may influence sensitivity to platinum chemotherapy and PARP inhibitors, but this is informational and does not change the coverage instructions in this policy.

Therapies and Pharmacologic Context

Agent	Clinical context / evidence	Coverage status
Olaparib	PARP inhibitor shown to be effective in HR-deficient (BRCA1/2‑mutated) epithelial ovarian cancer; multiple randomized phase II/III trials demonstrate therapeutic benefit when used as part of treatment strategies for advanced EOC; mechanism: inhibits PARP catalytic activity leading to impaired single‑strand break repair and synthetic lethality in HR‑deficient tumors.	Covered
Rucaparib	PARP inhibitor with demonstrated clinical activity in HR‑deficient epithelial ovarian cancer in randomized trials; discussed alongside olaparib and niraparib with noted efficacy but also concerns about toxicity and development of resistance.	Covered
Niraparib	PARP inhibitor shown therapeutic benefit in HR‑deficient (including BRCA‑mutated) epithelial ovarian cancer in randomized studies; safety profile and resistance mechanisms are discussed in the literature, and combinations with other agents have been explored.	Covered

Definitions and Key Terms

inv-65: Germline multigene panel testing — required panel composition and duplication/deletion analysis notes

Panel composition requirementMultigene panel must include BRCA1, BRCA2, CDH1, MLH1, MSH2, MSH6, PALB2, PTEN, STK11, TP53 and full duplication/deletion analysis

Duplication/deletion analysisFull duplication/deletion (LGR) analysis must include BRCA1, BRCA2, MLH1, MSH2, and STK11

Testing frequencyPanel testing medically necessary once per lifetime when NCCN criteria met

inv-66: High-, moderate-, low-risk categories — pre-test probability categories

Risk categoriesLow: <10%; Moderate: 10–25%; High: >25% pre-test probability

UseCategories guide testing referral and management decisions

Line of Therapy Context

Administrative Notes and Policy Scope

Note

No explicit prior authorization details in cited background sections

Some background chunks do not specify prior authorization requirements or codes; refer to the policy's prior authorization sections for explicit instructions.

Note

References/policy history contain no authorization triggers

References and policy history excerpts contain no explicit authorization or denial triggers; always follow the policy's prior authorization and documentation sections for requirements.

Policy history and review dates are provided in the bulletin (Effective date: 04/07/1998; Last review: 02/09/2024; Next review: 02/22/2024). No specific documentation forms are included within the supplied chunks, though prior authorization and pedigree documentation requirements are described elsewhere in the policy.

Revision History

2024-02-09policy_reviewLatest

Policy last reviewed on 02/09/2024; effective date remains 04/07/1998 and next review scheduled 02/22/2024.

1998-04-07policy_effective

Policy originally became effective on 04/07/1998.

OpenPayer

Breast and Ovarian Cancer Susceptibility Gene Testing, Prophylactic Mastectomy, and Prophylactic Oophorectomy

Coverage Criteria and Medical Necessity

Billing and Coding

Provider Requirements, Prior Authorization, and Documentation

Genes, Panels, and Testing Requirements

Clinical Guidance, Background, and Limitations

Therapies and Pharmacologic Context

Definitions and Key Terms

Line of Therapy Context

Administrative Notes and Policy Scope

Revision History