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CurrentAloha CarePolicy MP-10

Genetic Counseling and Testing for Hereditary Breast and Ovarian Cancer Syndrome (HBOC)

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Defines medical necessity criteria, counseling requirements, limitations, and coding guidance for BRCA1/2 genetic testing and associated genetic counseling for members of Aloha Care plans (including QUEST Integration Medicaid and AlohaCare Advantage Plus SNP Medicare).

Policy Summary

PayerAloha Care

PolicyGenetic Counseling and Testing for Hereditary Breast and Ovarian Cancer Syndrome (HBOC)

Policy CodePolicy MP-10

Change TypeNo material clinical or coverage changes

Effective DateSep 6, 2019

Last ReviewSep 6, 2020

Next Review DateSep 6, 2020

Key ActionObtain prior authorization and submit documentation of medical necessity (including planned treatment for companion diagnostics) before genetic counseling or BRCA testing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

once-in-a-lifetimeBRCA testing frequency limit

1 pre + 1 postCounseling visits covered

Medicare exceptionMedicare exception

5-20%BRCA attribution

L36161Referenced LCD

Coverage Criteria for BRCA1/BRCA2 Testing and Genetic Counseling

HBOC Genetic Testing — Medically Necessary Indications

BRCA1/2 genetic testing is considered medically necessary for high‑risk individuals when ANY of the following criteria are met (criteria vary slightly for Quest vs Medicare where noted):

Known familial pathogenic variant: Individual from a family with a known BRCA1/2 pathogenic or likely pathogenic variant (including variants found on research testing)

Testing of at-risk relatives is limited to the identified familial BRCA variant (targeted single-site analysis)

Personal history: breast cancer: Personal history of breast cancer (invasive or DCIS) with one or more specified high‑risk features (examples include: diagnosed ≤45 years; diagnosed 46–50 years with an additional breast primary or close relative with breast cancer; triple‑negative ≤60 years; diagnosis at any age with a close relative diagnosed ≤50 years, ovarian carcinoma, male breast cancer, metastatic prostate cancer, pancreatic cancer, or ≥2 additional breast cancers in patient/relatives)age and family‑history dependent

See policy sections for the full nested list of qualifying high‑risk features

Policy Summary

PayerAloha Care

PolicyGenetic Counseling and Testing for Hereditary Breast and Ovarian Cancer Syndrome (HBOC)

Policy CodePolicy MP-10

Change TypeNo material clinical or coverage changes

Effective DateSep 6, 2019

Last ReviewSep 6, 2020

Next Review DateSep 6, 2020

Key ActionObtain prior authorization and submit documentation of medical necessity (including planned treatment for companion diagnostics) before genetic counseling or BRCA testing.

SourceLink

On This Page

Covered Indications and Context

See coverage criteria set: known family BRCA pathogenic variant; personal history with specified high-risk features; family-history only patterns; tumor profiling-detected BRCA variant; FDA-approved companion diagnostic indications.

Covered when ANY of the following covered-indication groups apply (policy contains detailed nested age and family-history thresholds):

Known familial pathogenic variant: Individual from a family with a known BRCA1/2 pathogenic/likely pathogenic variant

Targeted single-site testing limited to the familial variant

Personal history with specified high-risk features: Personal history of breast, ovarian (including fallopian tube and primary peritoneal), pancreatic, or prostate cancer with qualifying age, histology, or family-history features as detailed in policyage, histology, and family-history dependent

Includes triple‑negative breast cancer, early onset breast cancer, metastatic prostate cancer; see policy for full nested criteria

Family-history only patterns: No personal cancer history but ≥1 first‑ or second‑degree close blood relative meeting defined cancer/age/feature thresholds (see policy) or Ashkenazi Jewish ancestry where founder-site testing is recommended firstfamily-history patterns defined in policy

See policy for nested relative-degree and age thresholds

Tumor profiling-detected BRCA variant: Tumor profiling that detects a BRCA1/2 pathogenic variant when no prior germline testing has been performed

Germline follow-up testing considered medically necessary

FDA-approved companion diagnostic indications: BRCA1/2 testing for FDA‑approved companion diagnostic indications when patient has appropriate cancer diagnosis and planned therapy is FDA‑approved and dependent on BRCA1/2 statusall companion diagnostic criteria must be met

Documentation of planned treatment required with authorization request; examples include olaparib, talazoparib, rucaparib

Use in context of malignant neoplasms of breast, ovary, pancreas, fallopian tube, prostate, carcinoma in situ of breast, and relevant family/personal history codes

Use appropriate ICD-10-CM diagnosis codes when submitting claims to support the clinical indication for BRCA testing:

Diagnosis code context: Applicable malignant neoplasm and personal/family history ICD‑10‑CM codes include breast (C50.x, D05.x for in situ), ovary (C56.x), fallopian tube (C57.00–C57.02), pancreas (C25.x), prostate (C61), and family/personal history codes (Z80.3, Z80.41, Z80.42, Z85.07, Z85.3, Z85.43, Z85.46)

Use the code(s) that accurately reflect the member's diagnosis or history

HBOC-related testing as discussed in cited guidelines and literature (references only)

Policy references supporting HBOC-related testing include professional society guidance and the MolDX Local Coverage Determination; these citations do not enumerate operational coverage rules but support the clinical rationale:

Guideline and resource citations: References include ACOG Hereditary Cancer Syndromes guidance, CDC HBOC information, peer‑reviewed literature (e.g., Chen et al., Evans et al.), and the CMS MolDX Local Coverage Determination L36161

See the policy reference list for full citation details

BRCA1/BRCA2 testing discussed in guidelines and MolDX LCD (references only)

BRCA1/BRCA2 testing and coverage considerations are discussed in cited guidelines and the MolDX L36161 LCD:

MolDX and guideline support: The CMS MolDX Local Coverage Determination (L36161) and multiple professional guidelines are cited as supporting resources for BRCA1/2 genetic testing decisions

Refer to L36161 for Medicare-specific coverage details

References supporting BRCA testing per guidelines and MolDX LCD (references only)

Selected references that support BRCA testing indications (reference list only):

References supporting BRCA testing: Citations include Chen et al., Evans et al., ACOG, CDC, and the MolDX L36161 local coverage determination

These references underpin the policy's criteria; they do not replace the coverage logic provided elsewhere in the policy

Citations (ACOG, MolDX) support indications described elsewhere

Citations reinforce the indications described elsewhere in this policy (references only):

Support for criteria: ACOG, CDC, and MolDX L36161 citations are provided to support the clinical rationale and criteria detailed in the policy

See the policy's coverage criteria section for operational decision logic

Confirmation testing after direct-to-consumer genetic test reports (particularly for BRCA1/2)

When a direct-to-consumer (DTC) genetic test reports a BRCA1/2 result, clinical confirmation is recommended:

Confirmation after DTC results: Clinical confirmation testing in a certified clinical laboratory is recommended following a direct‑to‑consumer BRCA1/2 result before using it for clinical decision‑making

Policy references multiple reports of false positives from DTC tests; lack of confirmation may risk inappropriate care

Mammographic screening and genetic testing considerations for young women with family history (references)

The policy cites literature addressing mammographic screening and genetic testing considerations for young women with a family history of breast cancer (references only):

Mammographic screening references: Cited literature (e.g., Tyndel et al.) discusses mammographic screening knowledge and views in young women with a family history of breast cancer; these citations inform clinical context but do not specify coverage rules in this section

See other policy sections for coverage criteria tied to age or family history

Eligibility and Required Clinical Context

Coverage commonly requires a qualifying family history: first- or second-degree close blood relatives with specified cancers and age thresholds inform eligibility. The policy directs that testing should begin with a relative affected by a BRCA-related cancer when possible, and documents that targeted testing is required when a familial pathogenic variant is known. For individuals with limited family structure (including adopted persons), the record must document medical necessity and genetic counseling prior to testing.

When available, testing should start with an affected relative (including male relatives) who has a BRCA-related cancer before testing unaffected individuals. The policy also specifies that Ashkenazi Jewish founder mutation testing should be performed first when ancestry indicates, with comprehensive testing considered if other ancestry or criteria apply.

The policy allows BRCA testing for adopted individuals with early-onset breast cancer (≤50 y/o) when suspicion for BRCA-related disease exists, provided medical necessity and genetic counseling documentation are present.

Allogeneic bone marrow transplant recipients should not have BRCA molecular testing performed on blood or buccal specimens due to donor DNA contamination; fibroblast-derived DNA is preferred when available.

Individuals with limited family history or structure may still be eligible for BRCA testing, but the medical record must document the rationale for medical necessity and that genetic counseling occurred prior to testing.

The policy states a relative-first testing approach: prioritize sequencing an affected relative to identify a familial variant before testing unaffected family members; this supports targeted single-site testing when a familial pathogenic variant is found.

Ashkenazi Jewish founder-specific BRCA mutation testing is identified as the initial step for individuals with that ancestry; comprehensive BRCA1/2 testing is considered if other ancestry or clinical criteria warrant broader analysis.

The policy requires documentation of genetic counseling and medical necessity in the medical record to support eligibility when family history is limited or when testing is clinically indicated despite atypical family structures.

Family history thresholds used to determine eligibility incorporate age at diagnosis and cancer types in affected relatives; the policy references these nested family-history criteria and requires providers to document how the member meets the relevant thresholds.

The policy notes that when a familial pathogenic variant is known, affected relatives are eligible only for targeted single-site analysis of that variant rather than full gene sequencing, and this must be documented.

No specific prior testing steps (beyond the recommendation to test an affected relative first when possible) are mandated as prerequisites for coverage in the provided excerpts; documentation of medical necessity and genetic counseling is required to support testing.

When affected relatives are unavailable, the policy allows testing after documentation justifies testing in the proband’s medical record and after genetic counseling has been provided.

Pre-test and post-test genetic counseling is considered medically necessary when the patient meets criteria for HBOC genetic testing; the policy covers one pre-test and one post-test counseling visit when criteria are met and counseling is provided by qualified professionals.

Provider Actions, Documentation, and Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is required for genetic counseling and genetic testing. For FDA‑approved companion diagnostic indications, documentation of planned treatment must be submitted with the authorization request; the patient’s medical record must document the medical necessity for services covered by this policy. (See: policy procedure and companion diagnostic criteria.)

One pre-test and one post-test genetic counseling visit are included when the patient meets testing criteria.
For companion diagnostics, include documentation of planned treatment with the authorization request.

Billing Rule

Verify prior authorization for listed codes

Verify prior authorization requirements for the CPT/HCPCS procedure codes listed in the policy before submitting claims or ordering tests, as the policy lists specific covered and not‑covered codes relevant to HBOC testing and counseling.

Covered procedure/counseling codes include 81162‑81167, 81212, 81215‑81217, 96040, S0265.
Not covered codes include 81432, 81445, 81455, and 81479 which may be denied if billed.

Note

Reference to MolDX L36161

The policy cites the CMS MolDX Local Coverage Determination L36161 for BRCA1/BRCA2 genetic testing as a referenced resource that may inform coverage and authorization rules; providers should consult L36161 for Medicare‑specific guidance.

MolDX L36161 is referenced repeatedly in the policy’s references/resources.
L36161 may contain Medicare coverage or prior authorization details relevant to BRCA testing.

Note

MolDX L36161 referenced (resource)

MolDX Local Coverage Determination L36161 (BRCA1 and BRCA2 Genetic Testing) is listed repeatedly in the policy’s references; use that LCD as a resource for additional coverage details that are not specified in this document excerpt.

Noridian/MolDX L36161 is cited multiple times in the References/Resources section.
The policy’s references point to L36161 for supplemental coverage information.

Note

Refer to MolDX L36161 for Medicare coverage details

For Medicare members, the policy repeatedly cites MolDX L36161; consult that LCD for any Medicare prior authorization or coverage rules that may apply to BRCA1/2 testing and companion diagnostics.

MolDX L36161 is identified as the CMS Local Coverage Determination for BRCA1/2 testing.
Medicare providers should review L36161 for Medicare‑specific instructions.

Note

See MolDX L36161 for potential prior authorization rules

See MolDX L36161 for potential prior authorization or coverage rules—this policy references the MolDX LCD as the external source that may contain operational authorization requirements not specified here.

Policy references L36161 as a source that may include prior authorization guidance.
The policy itself does not enumerate all Medicare operational rules and points to the LCD for those details.

Prior Authorization

No prior authorization guidance in references

The References/Resources sections in these excerpts do not include explicit prior authorization instructions; the policy text repeatedly points to external references (including MolDX L36161) rather than providing in‑document PA procedures.

No explicit prior authorization procedures are stated in the references windows.
Providers should follow payer operational processes and consult L36161 or payer prior authorization portals for instructions.

Note

MolDX L36161 referenced (repeated)

MolDX L36161 is cited multiple times across the references list as the Local Coverage Determination for BRCA1/2 testing; the policy relies on that external document for additional coverage context.

Repeated MolDX L36161 citations appear in the References/Resources section.
MolDX is presented as a primary external coverage resource for BRCA testing.

Prior Authorization

Prior authorization not specified in these excerpts

The document emphasizes the role of confirmation testing and clinical follow‑up but does not specify prior authorization requirements in these excerpted chunks; providers must rely on the policy’s PA statements and external payer resources.

Confirmation testing and clinical follow‑up for DTC results are emphasized, but PA detail is not provided in these excerpts.
When PA is required, use the policy PA statements and payer resources to complete authorization.

Prior Authorization

Prior authorization not specified in excerpt

The provided excerpts do not specify prior authorization processes or operational PA rules; where PA is required the policy directs submission of medical‑necessity documentation, but specific PA workflows are not given here.

No explicit PA processes are present in these chunks.
Submit medical record documentation to support medical necessity when requesting authorization, per the policy.

Prior Authorization

Prior authorization not specified in reference pages

These reference‑only sections do not state explicit prior authorization requirements; the policy’s PA requirement appears in the procedure section (see chunk 8), while many reference entries are bibliographic and do not include operational rules.

References windows list guidance documents and literature but do not provide PA instructions.
Operational PA rules are given in the Procedure section, not in the reference entries.

Step Therapy

Relative‑first testing recommendation

When a familial BRCA pathogenic or likely pathogenic variant is known, testing of at‑risk relatives is limited to targeted single‑site analysis; testing should begin with a relative affected by BRCA‑related cancer when possible (relative‑first testing).

Testing of relatives is limited to the identified familial BRCA variant (targeted single‑site analysis).
Policy states: "Testing should begin with a relative who has had a BRCA‑related cancer... before testing individuals without cancer."

Step Therapy

Step therapy not addressed in references

No step therapy requirements are described in these reference sections or bibliographic entries; the policy does not establish step therapy protocols beyond the relative‑first testing recommendation and testing limitations noted elsewhere.

Reference entries do not describe step therapy.
Policy excerpts contain no operational step therapy triggers.

Note

Documentation Required

Medical necessity and planned treatment documentation

Submit documentation of medical necessity with prior authorization requests; for companion diagnostic testing, include documentation of planned treatment with the authorization request as required by the policy.

Patient medical record must contain documentation supporting medical necessity for services.
Documentation of planned treatment must be submitted with authorization for companion diagnostics.

Billing Rule

Diagnosis coding guidance

When submitting claims or authorization requests, use appropriate ICD‑10‑CM diagnosis codes to identify relevant malignancies and family/personal history (examples include C50.x for breast cancer, C56.x for ovary, C25.x for pancreas, and family history codes Z80.3, Z80.41, Z85.3).

Policy’s coding section lists covered ICD‑10‑CM diagnosis codes for breast, ovary, pancreas, fallopian tube, prostate, carcinoma in situ, and family/personal history codes.
Include diagnosis codes that match the clinical indication when requesting authorization.

Note

Supporting references

The policy’s references and bibliography are provided to substantiate clinical rationale but do not themselves set operational documentation submission requirements; they include ACOG, CDC, J Clin Oncol, MolDX L36161 and other citations that may be used to support medical necessity.

References list ACOG, CDC, J Clin Oncol, MolDX L36161 and other literature.
Use cited guidance to support clinical rationale in documentation when appropriate.

Note

Documentation Required

References only — no submission requirements here

This part of the document is a references list and does not specify documentation submission workflows or operational authorization/denial triggers; providers should follow the policy’s procedure section and payer authorization portals for submission requirements.

Bibliographic entries do not include operational guidance.
Operational submission rules are described in the Procedure and Limitations sections (see chunk 8 and 15).

Note

Documentation Required

Confirmation of direct‑to‑consumer (DTC) results recommended

Direct‑to‑consumer (DTC) genetic test results should be confirmed with clinical laboratory testing before using results for clinical decision‑making; false positives from DTC tests are noted in the references and may lead to inappropriate care if unconfirmed.

References (Tandy‑Conner et al.) highlight false‑positive results from DTC tests and the importance of clinical confirmation testing.
Policy repeatedly emphasizes clinical confirmation testing for DTC results to ensure appropriate patient care.

Denial Risk

Risk from unconfirmed direct‑to‑consumer results

Ordering or relying on unconfirmed direct‑to‑consumer genetic test results risks inappropriate patient care due to false positives; the policy stresses that clinical confirmation testing should be performed following DTC test reports.

Multiple citations in the references highlight false positives from DTC tests and recommend confirmatory clinical testing.
Clinical confirmation is recommended before using DTC results for treatment decisions.

Note

Denial Risk

Denial risk for not‑covered panel codes

Claims for genomic sequence analysis panels and certain targeted genomic panels (CPT 81432, 81445, 81455) and unlisted molecular pathology (81479) are listed as Not Covered and may be denied if billed.

81432, 81445, 81455, and 81479 are explicitly listed under HCPCS/CPT Not Covered.
Providers should avoid billing these not‑covered panel codes or verify coverage prior to ordering.

Denial Risk

No authorization/denial rules in reference listings

The references sections do not describe operational denial triggers or explicit authorization/denial criteria; denial risks are stated elsewhere in the policy (e.g., not‑covered codes, age exclusions) and providers should follow the Procedure and Limitations sections for those rules.

Reference windows are bibliographic and do not include operational denial triggers.
Denial risks such as not‑covered codes and age exclusions are documented in the Limitations and Coding sections (see chunk 15 and 21).

Note

Coding Guidance and Listed Procedure/Diagnosis Codes

ICD-10-CM Covered/InformationalICD-10

C25.0-C25.9	Malignant neoplasm of pancreas
C48.1	Malignant neoplasm of specified parts of peritoneum
C50.011- C50.929	Malignant neoplasm of breast (various sites)
C56.0-C56.9	Malignant neoplasm of ovary
C57.00-C57.02	Malignant neoplasm of fallopian tube
C61	Malignant neoplasm of prostate
D05.00-D05.82	Carcinoma in situ of breast
Z80.3	Family history of malignant neoplasm of breast
Z80.41	Family history of malignant neoplasm of ovary
Z80.42	Family history of malignant neoplasm of prostate

1–10 of 14

1/2

Covered ICD-10-CM CodesICD-10Covered

C25.0-C25.9	Malignant neoplasm of pancreas
C48.1	Malignant neoplasm of specified parts of peritoneum
C50.011- C50.929	Malignant neoplasm of breast (various sites)
C56.0-C56.9	Malignant neoplasm of ovary
C57.00-C57.02	Malignant neoplasm of fallopian tube
C61	Malignant neoplasm of prostate
D05.00-D05.82	Carcinoma in situ of breast (lobular, intraductal, other specified)
Z80.3	Family history of malignant neoplasm of breast
Z80.41	Family history of malignant neoplasm of ovary
Z80.42	Family history of malignant neoplasm of prostate

1–10 of 14

1/2

HCPCS/CPT CoveredCPT|HCPCSCovered

81162-81167	BRCA1 (BRCA1, DNA repair associated), BRCA2 (DNA repair associated) gene analysis; do not report 81162 in conjunction with 81163-81167, 81216, 81217, 81432
81212	BRCA1, BRCA2 gene analysis; 185delAG, 5385insC, 6174delT variants (founder variants)
81215-81217	BRCA1 gene analysis (and related BRCA testing codes)
96040	Medical genetics and genetic counseling services, each 30 minutes face-to-face with patient/family
S0265	Genetic counseling, under physician supervision, each 15 minutes

HCPCS/CPT Not CoveredCPTNot Covered

81432	Genomic sequence analysis panel for hereditary breast cancer-related disorders; must include sequencing of at least 14 genes (eg, ATM, BRCA1, BRCA2, BRIP1, CDH1, MLH1, MSH2, MSH6, NBN, PALB2, PTEN, RAD51C, STK11, TP53) - Not Covered
81445	Targeted genomic sequence analysis panel, solid organ neoplasm, DNA and RNA, 5-50 genes - Not Covered
81455	Targeted genomic sequence analysis panel, solid organ or hematolymphoid neoplasm, 51+ genes - Not Covered
81479	Unlisted molecular pathology procedure - Not Covered

Referenced Coverage Determinationmixed

L36161

MolDX: BRCA1 and BRCA2 Genetic Testing (Local Coverage Determination referenced)

Excluded Tests and Indications

Individuals with no personal or family history of cancer are identified as not covered in the QUEST context, and the policy specifies Medicare exceptions where testing without a personal cancer history is not covered for Medicare-eligible individuals. These operational not-covered scenarios are listed under policy limitations.

The policy explicitly lists multi-gene hereditary breast cancer panels (CPT 81432), targeted genomic panels for neoplasms (CPT 81445, 81455), and the unlisted molecular pathology code (CPT 81479) as Not Covered.

Reference-only sections of the policy include bibliography and guideline citations but do not themselves enumerate additional tests or indications that are not covered.

Several reference entries cite MolDX L36161 and guideline literature but do not list explicit not-covered tests or operational exclusions within those reference blocks.

Reference listings support the policy rationale (e.g., penetrance estimates, guideline statements) yet do not contain specific not-covered test lists in those excerpted chunks.

The references section includes MolDX L36161 and other citations as background support; it does not itself identify additional test exclusions beyond the policy’s limitations section.

Reference text reiterates the need for clinical confirmation of direct-to-consumer genetic test results but does not list explicit test exclusions; the emphasis is on confirmatory testing to avoid inappropriate care from false positives.

Reference-only material repeatedly cites MolDX and clinical studies as support for the policy and does not enumerate additional not-covered tests in the provided excerpts.

The document highlights the risk of false-positive results from DTC genetic tests and consistently recommends clinical confirmation testing prior to using DTC findings for clinical decisions; these recommendations are presented in reference content rather than as explicit coverage exclusions.

Definitions and Terms

Affected individual — definition

DefinitionA patient or relative of a patient with a cancer diagnosis that is associated with the particular syndrome of concern (for this policy, BRCA1 or BRCA2).

ScopeApplies to individuals who are patients or blood relatives (first-, second-, third-degree defined elsewhere in policy).

Early-onset breast cancer — definition (≤ 50 years)

DefinitionBreast cancer occurring at the age of 50 years old or younger.

IncludesApplies to invasive breast cancer and ductal carcinoma in situ (DCIS) as defined in the policy.

RelevanceEarly-onset status is a high-risk feature used in coverage criteria for BRCA testing.

Triple-negative breast cancer — definition and association with BRCA1

DefinitionAny breast cancer that lacks over-expression of estrogen receptor (ER), progesterone receptor (PR), and HER2/neu (triple-negative).

Clinical featuresClinically more aggressive and less responsive to standard treatment; associated with poorer prognosis.

AssociationDiagnosed more frequently with BRCA1 mutations.

Autosomal dominant — definition

DefinitionAn inheritance pattern in which a pathogenic or likely pathogenic variant is present in one copy of a given gene (autosomal dominant).

ImplicationA single pathogenic variant in BRCA1 or BRCA2 can confer hereditary cancer risk in a family.

ContextMost hereditary cancer syndromes in this policy exhibit autosomal dominant inheritance.

BRCA gene analysis codes — CPT/HCPCS codes referenced for BRCA testing

Covered BRCA analysis codesCPT/HCPCS: 81162-81167; 81212; 81215-81217; Genetic counseling codes: 96040, S0265.

Reporting noteDo not report 81162 in conjunction with 81163-81167, 81216, 81217, or 81432 (per coding guidance).

PurposeCodes correspond to BRCA1/BRCA2 gene analysis and specified founder-variant testing and counseling services.

MolDX L36161 — CMS LCD referenced

ResourceMolDX Local Coverage Determination L36161: MolDX: BRCA1 and BRCA2 Genetic Testing (Noridian Healthcare Solutions, Jan 2019).

RoleCited as a referenced coverage/resource document informing BRCA1/BRCA2 testing guidance and Medicare considerations.

Where to find detailsSee MolDX L36161 for Medicare-specific coverage and potential prior authorization rules referenced in this policy.

penetrance — definition/context

DefinitionPenetrance refers to estimates of BRCA1/BRCA2 mutation-associated cancer risk and should reflect the cancer burden in the family.

ContextPolicy cites literature noting penetrance estimates should be interpreted in the context of family cancer history (Evans et al., BMC Cancer).

UsePenetrance informs risk assessment and helps determine eligibility for testing under family-history criteria.

MolDX L36161 reference (duplicate)

ResourceMolDX Local Coverage Determination L36161 referenced repeatedly as a BRCA1/BRCA2 testing resource (Noridian Healthcare Solutions, 2019).

Policy useCited among references supporting coverage criteria and guidance in this policy's reference list.

NoteConsult L36161 for further operational or Medicare-specific details not enumerated in this policy excerpt.

MolDX L36161 (duplicate reference)

ResourceMolDX Local Coverage Determination L36161 is cited multiple times in the references as informing BRCA1/BRCA2 testing coverage.

Reference detailListed among clinical and policy references used to develop the AlohaCare policy recommendations.

ActionRefer to MolDX L36161 for specifics on coverage interpretation for Medicare beneficiaries.

MolDX L36161 (reference entry)

Resource entryMolDX: Local Coverage Determination (L36161) — Noridian Healthcare Solutions, cited in the policy references list.

PurposeServes as a referenced LCD for BRCA1 and BRCA2 genetic testing informing this policy's recommendations.

RecommendationSee the LCD for Medicare prior authorization or coverage rules not specified in this document excerpt.

ACOG Hereditary Cancer Syndromes (reference)

GuidanceACOG: Hereditary Cancer Syndromes — cited as a referenced guidance document (last reviewed Oct 2018).

RoleListed among professional society resources supporting the policy's clinical rationale for HBOC testing and counseling.

UseMay be used to substantiate clinical rationale and counseling recommendations when testing is offered.

HBOC — definition

DefinitionHereditary Breast and Ovarian Cancer (HBOC) syndrome: a hereditary cancer predisposition primarily associated with pathogenic variants in BRCA1 and BRCA2.

Associated cancersHBOC is primarily associated with breast, ovarian, and fallopian tube cancers and increased risk for other cancers.

ContextHBOC is the condition addressed by this policy's genetic testing and counseling criteria.

direct-to-consumer genetic tests — definition and caution about false positives

DefinitionDirect-to-consumer (DTC) genetic tests are marketed directly to consumers and can produce results that require clinical confirmation due to risk of false positives.

Policy cautionThe policy highlights false-positive results from DTC tests and emphasizes the importance of clinical confirmation testing for appropriate patient care.

Action for providersClinical confirmation testing should be performed before using DTC results for medical decision-making.

Clinical confirmation testing — definition

DefinitionClinical confirmation testing: confirmatory genetic testing conducted in a clinical laboratory setting after a direct-to-consumer genetic test to validate results before they are used for medical decision-making.

RationaleEmphasized because false-positive DTC results may lead to inappropriate patient care if not confirmed clinically.

Recommended practicePerform confirmatory testing in a certified clinical laboratory prior to making treatment or surveillance decisions based on DTC results.

Clinical confirmation testing — duplicate definition entry

Definition (duplicate)Confirmatory testing performed in a clinical setting (e.g., by a certified laboratory) to validate results reported by direct-to-consumer genetic tests before clinical use.

Policy noteThe document repeatedly stresses the importance of clinical confirmation to avoid acting on false-positive DTC findings.

ImplementationDocumentation of confirmed results may be required for clinical actions or prior authorization for treatment-related testing.

Genetic Counseling and Testing for Hereditary Breast and Ovarian Cancer Syndrome (HBOC)

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Coverage Criteria for BRCA1/BRCA2 Testing and Genetic Counseling

Covered Indications and Context

Eligibility and Required Clinical Context

Provider Actions, Documentation, and Prior Authorization

Coding Guidance and Listed Procedure/Diagnosis Codes

Excluded Tests and Indications

Background and Evidence Summary

Definitions and Terms

Policy Dates and Revision History