CurrentProvidence Health PlanPolicy 143

Genetic Testing for Hereditary Breast, Ovarian, Pancreatic, and Prostate Cancer

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This policy defines medical necessity criteria, coverage limits, and non-covered genetic tests for hereditary breast, ovarian, pancreatic, and prostate cancer for Providence Health Plan commercial products and related companies.

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CurrentProvidence Health PlanPolicy 143

Genetic Testing for Hereditary Breast, Ovarian, Pancreatic, and Prostate Cancer

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Policy Summary

PayerProvidence Health Plan

PolicyGenetic Testing for Hereditary Breast, Ovarian, Pancreatic, and Prostate Cancer

Policy CodePolicy 143

Change TypeAnnual review — no material changes

Effective DateJul 1, 2026

Last ReviewJul 1, 2026

Next Review DateJun 1, 2027

Key ActionObtain prior authorization with the full documentation checklist (test name/genes, laboratory, clinical and genetic counseling notes, family history, prior test results, and billed CPT/HCPCS codes).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Commercial onlyPlan products indicated

3Coverage pathways

MultipleNamed non-covered panels

20+Genes referenced

ChecklistRequired documentation

81479Unlisted code called out

Coverage Criteria

Genetic Testing: Family with a Known Mutation

Covered when ALL of the following are met

I. Family with known mutation: A. Genetic Counseling general criteria have been met; and B. The patient is from a family with a known pathogenic/likely pathogenic variant in a hereditary breast, ovarian, pancreatic, and/or prostate cancer gene; and C. Gene testing is specific to the familial pathogenic/likely pathogenic variant.

Genetic Testing: Personal History of Cancer

Covered when BOTH A and B are met

II. Personal History of Cancer: A. Genetic Counseling general criteria have been met; and B. Any one or more of the following criteria (1-8) are met.

II.B criteria details: 1. Personal history of breast cancer with subcriteria (a-d) including: a. Diagnosed ≤45 years; b. Diagnosed 46–50 with unknown/limited family history, multiple primaries, or ≥1 close relative with breast/ovarian/pancreatic/prostate cancer; c. Diagnosed ≥51 with ≥1 close relative with early breast (≤50), male breast, ovarian or pancreatic cancer, metastatic/high-risk prostate features, ≥3 total diagnoses of breast in patient/relatives, or ≥2 close relatives with breast or prostate cancer; d. Any age with treatment-related or tumor features (PARP inhibitor eligibility for metastatic disease, adjuvant olaparib for high-risk HER2‑negative disease, triple-negative histology, lobular with diffuse gastric history, male breast relative, or ethnicity with higher mutation frequency). 2. Epithelial ovarian, primary peritoneal, or specified ovarian tumor types. 3. Male breast cancer. 4. Pancreatic cancer. 5. Metastatic prostate cancer. 6. Prostate cancer with high-risk features, metastatic/node-positive disease, Ashkenazi Jewish ancestry, or close relative with early breast/male breast/ovarian/pancreatic cancer, or ≥3 close relatives with prostate and/or breast cancer on same side. 7. Personal and/or family history of ≥3 specified diagnoses (list includes breast, pancreatic, prostate [Gleason ≥7 or metastatic], melanoma, sarcoma, adrenocortical carcinoma, brain tumors, leukemia, diffuse gastric cancer, colon, endometrial, thyroid, kidney, Cowden syndrome manifestations, macrocephaly, GI hamartomatous polyps, ovarian sex cord tumors, testicular Sertoli cell tumors, childhood pigmentation of Peutz-Jeghers). 8. A known pathogenic/likely pathogenic variant detected by tumor profiling in the absence of germline analysis.

See policy text for full subcriteria and tumor lists.

Genetic Testing: No Personal History of Cancer

Covered when Genetic Counseling criteria met and one of the following is met

III.A: The patient has a first- or second-degree blood relative who meets criterion II.B above.

III.B: The patient has a first- or second-degree blood relative with at least two close blood relatives with breast cancer primaries on the same side of the family with at least one diagnosed at age 50 or younger.

Criterion III may apply to an affected third-degree relative if related through two male relatives; when possible test affected family members first and document reasons if unavailable.

Medical necessity coverage

Covered when medical necessity criteria are met for patients with personal or family histories suggestive of hereditary breast, ovarian, pancreatic, or prostate cancer, and for patients with known familial pathogenic/likely pathogenic variants.

Covered populations: Patients with a known familial pathogenic/likely pathogenic variant; patients with a personal history of relevant cancer and suggestive family history; unaffected individuals with a suggestive family history when criteria met; genetic panel testing when each gene included has demonstrated clinical utility.

Supported by NCCN and evidence reviews (Hayes).

Not supported panels

Not covered / limited:

Panels with genes lacking demonstrated clinical utility: Genetic panel tests that include additional genes not identified as hereditary breast, ovarian, pancreatic, and/or prostate cancer gene mutations and for which clinical utility has not been demonstrated are not supported for cancer risk assessment.

Hayes review found insufficient evidence for some multi-gene panels (e.g., myRisk) and the policy states panels including genes without demonstrated utility are not supported.

Evidence-supported coverage statements

Summary statements from evidence and professional societies

Evidence-supported indications: Genetic testing is supported for patients with a known cancer mutation and for patients with and without a personal history of cancer when clinically appropriate; testing can change management (surveillance, prophylactic procedures) and inform family members.

From evidence summary; panels limited to genes with demonstrated relevance.

Panel testing limitation: Evidence does not support use of genetic panels that include genes not identified as hereditary breast, ovarian, pancreatic, and/or prostate cancer genes for cancer risk assessment without additional evidence of analytic/clinical validity and utility.

From evidence summary.

ACOG recommendations: Genetic counseling is recommended for women with ovarian epithelial cancer and individuals with personal or family history of breast or ovarian cancer; offer risk-reducing bilateral mastectomy for BRCA or other actionable deleterious mutations predisposing to breast cancer; offer risk-reducing bilateral salpingo-oophorectomy for BRCA or other actionable deleterious mutations predisposing to ovarian cancer with individualized timing and complete tissue examination.

Initial or repeat genetic testing for hereditary breast, ovarian, pancreatic, and/or prostate cancer gene mutation(s) is not medically necessary when criteria I–III of this policy are not met. Repeat testing of the same gene(s) previously analyzed is not medically necessary. For patients who have received an allogeneic bone marrow transplant, testing is not medically necessary when only blood or buccal samples are available; in these cases a fibroblast culture is the only acceptable DNA source. (See policy sections IV–VI for details.)

Panels that include genes without demonstrated clinical utility for hereditary breast, ovarian, pancreatic, and/or prostate cancer are excluded from coverage. The clinical utility of each gene included in a panel must be demonstrated to establish medical necessity; panels that include additional genes of intermediate or low penetrance or genes of unestablished utility are not supported. External reviews (for example, the Hayes review of the myRisk 25-gene panel) found insufficient evidence to support some multi-gene panels.

Genetic panel testing that includes additional genes not identified as hereditary breast, ovarian, pancreatic, and/or prostate cancer genes is not covered as a method of cancer risk assessment. Evidence does not support use of panels containing genes of unknown or unestablished significance for these hereditary cancers without additional data demonstrating analytic and clinical validity and clinical utility.

If an unlisted code is submitted for services that are non-covered under this policy, the claim will be denied as not covered. Unlisted codes submitted for potentially covered services are subject to review; prior authorization is recommended to avoid post-service denial.

The policy explicitly lists multiple named multi-gene panels that are considered not medically necessary and serve as examples of tests that include extraneous genes (e.g., +RNAinsight for BreastNext, +RNAinsight for OvaNext, Breast/Gyn Cancer (GeneDx), BreastNext, CancerNext/CancerNext-Expanded, myRisk Hereditary Cancer, OvaNext, Riskguard, VistaSeq panels, and Invitae multi-cancer panels). These examples are illustrative and not exhaustive.

Testing that uses panels including genes of unknown or unestablished clinical significance for hereditary breast, ovarian, pancreatic, and/or prostate cancer is considered not medically necessary. The policy cautions that such results may prompt unnecessary interventions or additional testing and requires demonstration of clinical utility for each gene included in a panel.

BART testing for large rearrangements (e.g., large deletions and/or duplications) billed with codes such as 81164, 81166, and/or 81167 may be denied or considered not covered when the medical necessity criteria for hereditary breast, ovarian, pancreatic, and/or prostate cancer testing are not met. Prior authorization may be required per plan rules.

Revision history notes that in 3/2023 denials for non-covered testing were changed from an 'investigational' stance to 'not medically necessary'. This change is reflected in the policy's current denial/coverage language.

Covered Indications

Coverage for testing when patient is from family with known pathogenic/likely pathogenic variant, when patient has qualifying personal history of cancer per detailed criteria, or when an unaffected individual has qualifying family history per Section III.

Covered indications summary: Coverage includes: individuals from families with known pathogenic/likely pathogenic variants (targeted testing to the familial variant), individuals with a qualifying personal history of breast, ovarian, pancreatic, or prostate cancer per the detailed criteria, and unaffected individuals with qualifying family histories meeting Section III.

Testing must be specific to known familial variant when family mutation exists; panels may be used when each gene has demonstrated clinical utility.

Personal history of breast/ovarian/pancreatic/prostate cancer with suggestive family history; unaffected individuals with a suggestive family history; patients with known familial pathogenic/likely pathogenic variant(s).

Supported populations: Personal history of breast, ovarian, pancreatic, or prostate cancer with suggestive family history; unaffected individuals with a suggestive family history; and patients with known familial pathogenic/likely pathogenic variant(s) — evidence (Hayes systematic reviews) and guidelines (NCCN/ACOG) support clinical utility in these groups.

Eligibility Requirements

When evaluating family history for eligibility, both the maternal and paternal sides must be considered separately. For unaffected individuals, coverage requires documentation that family-history criteria are met (for example, a first- or second-degree relative meeting the personal-history criteria or two close blood relatives with breast cancer on the same side of the family, with at least one diagnosed at age ≤50). Pre-test genetic counseling and documentation of family history are required as part of the request.

Family history assessment should follow NCCN definitions of close blood relatives (first-, second-, and third-degree relatives on the same side of the family). For unaffected members, coverage is contingent on meeting the specified family-history thresholds and documenting why an affected relative could not be tested first when applicable.

For unaffected individuals, documentation must show that family history meets policy thresholds (e.g., a qualifying affected relative per Section II.B or multiple relatives with early-onset breast cancer). The request must include clinical notes, genetic counseling documentation, and prior related test results when available to establish eligibility.

When a familial pathogenic or likely pathogenic variant is known, testing for the at-risk individual must be targeted to that specific familial variant rather than ordering a broad panel. Targeted testing for the familial variant is the appropriate, medically necessary approach in these cases.

NCCN and guideline-based recommendations support targeted variant testing when a familial pathogenic/likely pathogenic variant is known. When targeted testing is not possible, pre-test counseling must document why an affected family member could not be tested first before testing an unaffected relative.

Coding and Billing Codes

Required billing codesmixed

All relevant CPT/HCPCS codes

Providers must include all relevant CPT/HCPCS codes billed with the request (no specific codes listed in this excerpt).

Billing/CPT/HCPCS codes referencedmixed

81162	Oncology (hereditary cancer), genomic DNA, 55 hereditary cancer predisposition genes, NGS and digital MLPA for variants, small indels (<40 bp)
81163	Companion code referenced with 81162 in panel reporting (document fragment)
01102U	Hereditary breast cancer-related disorders genomic sequence analysis panel (document fragment referencing 0102U/0103U types)
0137U	Targeted mRNA sequence analysis panel (document fragment)
0138U	Targeted mRNA sequence analysis panel (document fragment)
0155U	Gene-specific sequence analysis references (PIK3CA and others) (document fragment)
0238U	Hereditary cancer NGS panel / circulating tumor DNA test references (document fragment)
0651U	Oncology (Lynch syndrome) genomic DNA sequence analysis panel reference (document fragment)
81164	BART testing for large rearrangements - referenced as potentially denied when medical necessity not met
81166	BART testing for large rearrangements - referenced as potentially denied when medical necessity not met

1–10 of 12

1/2

Covered CPT/Proprietary Codes referencedmixed

0238U	Proprietary/unnamed test codes referenced in oncology hereditary cancer context
0651U	Proprietary/unnamed test codes referenced in oncology hereditary cancer context
81162	BRCA1, BRCA2 gene analysis; full sequence analysis and full duplication/deletion analysis
81163	BRCA1 and/or BRCA2 gene analysis; full sequence analysis

Additional molecular and hereditary cancer gene CPT codesCPT

81164	BRCA1/BRCA2 duplication/deletion analysis (context from listing)
81165	BRCA1 analysis; detection of large gene rearrangements / BRCA2 context
81166	BRCA2 full sequence analysis (context from listing)
81167	BRCA2 duplication/deletion analysis (detection of large gene rearrangements)
81212	BRCA1/BRCA2 analysis for specific common variants (e.g., 185delAG, 5385insC, 6174delT)
81215	BRCA1 specific variant analysis (185delAG, 5385insC, 6174delT)
81216	BRCA2 known familial variant or full sequence analysis (context shows both usages)
81217	BRCA2 known familial variant (context from listing)
81288	MLH1 promoter methylation analysis
81292	MLH1 full sequence analysis

1–10 of 25

1/3

Panel gene count groups — definitions and groupings

Panel size group: small5 or more genes (genomic sequence analysis panel, 5+ genes)

Panel size group: mid-range5–50 genes (solid organ neoplasm genomic sequence analysis panel, interrogation for sequence variants and copy number variants or rearrangements)

Panel size group: large51 or greater genes (genomic sequence analysis panel, interrogation for sequence and copy number variants)

Provider Actions and Requirements

Prior Authorization

Coverage requires meeting policy criteria

Genetic testing is covered only when the policy’s specific medical necessity criteria are satisfied — i.e., the patient meets the Family-with-known-mutation pathway, the Personal-history-of-cancer pathway, or the No-personal-history pathway described in Sections I–III; evidence that these criteria are met should be provided with the request.

Prior Authorization

Submit full documentation checklist with prior auth

Prior authorization requests must include the complete documentation checklist so reviewers can determine medical necessity and clinical utility for the requested test.

Specific gene, trade or proprietary test name (or every gene/component for custom tests)
Name of laboratory performing the test
Clinical notes including documentation of genetic counseling (how results will impact management) and, if relevant, pre-test counseling explaining why an affected family member cannot be tested first
Indication/signs/symptoms, prior related test results, family history, how results will impact care

Definitions

Limited family history — definition

DefinitionA limited family history occurs when a 1st, 2nd and 3rd generation pedigree cannot be obtained or when there are too few family members in each generation to reasonably see a pattern of inheritance.

ImplicationMay affect application of age- and family-based criteria for genetic testing when full pedigree information is unavailable.

Documentation noteWhen limited family history is present, provide available family information and explain constraints in the pre-test counseling notes.

Genetic Panel Testing — scope when medical necessity met

When allowedWhen medical necessity criteria are met, genetic panel testing may include one or more of any combination of the genes listed in the policy.

Acceptable panels

Background

Hereditary mutations in multiple genes — including high-profile genes such as BRCA1 and BRCA2 as well as other predisposition genes (e.g., PALB2, PTEN, TP53, CHEK2, MLH1, MSH2, MSH6, PMS2, RAD51C, RAD51D, and others) — increase lifetime risk for breast, ovarian, pancreatic, and prostate cancers. Genetic testing informs risk assessment, influences management (surveillance, eligibility for prophylactic surgery, and systemic therapy decisions such as PARP inhibitor candidacy), and enables cascade testing of family members. Pre-test genetic counseling and documentation are recommended to ensure appropriate test selection and interpretation.

Revision History

2026-07-01Annual updateLatest

Annual update: Added clarifying language to criterion II.B.2 and added an example of a not medically necessary genetic panel; policy effective date updated to 2026-07-01.

2026-01-01Code set update

Q1 2026 code set update applied to the policy.

2025-09-01Annual update

Policy Summary

PayerProvidence Health Plan

PolicyGenetic Testing for Hereditary Breast, Ovarian, Pancreatic, and Prostate Cancer

Policy CodePolicy 143

Change TypeAnnual review — no material changes

Effective DateJul 1, 2026

Last ReviewJul 1, 2026

Next Review DateJun 1, 2027

SourceLink

On This Page

From ACOG practice bulletin (2018, reaffirmed 2023) cited in document.

Hayes assigned 'A' for affected individuals with suggestive family history and 'B' for unaffected individuals with family history; NCCN guidance lists actionable genes.

Patients with a known cancer mutation and patients with and without a personal history of cancer when clinically appropriate — testing can affect management and inform family members.

Clinical utility: Patients with a known cancer mutation and patients with and without a personal history of cancer when clinically appropriate may benefit from testing because results can affect management (surveillance, prophylactic surgery, treatment selection) and inform cascade testing of family members.

Supported by evidence summaries and professional society recommendations (NCCN, ACOG).

Women with ovarian epithelial cancer — Genetic counseling recommended.

Counseling recommendation: Genetic counseling is recommended for all women with ovarian epithelial cancer (including fallopian tube and primary peritoneal cancers) and for individuals with a personal or family history of breast or ovarian cancer.

ACOG practice bulletin (2018, reaffirmed 2023).

Hereditary breast, ovarian, pancreatic, and prostate cancer genetic testing using genomic DNA sequence analysis and panels (including BRCA1/2 and other predisposition genes).

Test types included: Hereditary breast, ovarian, pancreatic, and prostate cancer genetic testing includes genomic DNA sequence analysis and panels (including BRCA1/2 and other predisposition genes); includes full sequence and duplication/deletion analysis and panels interrogating sequence and copy number variants; panel sizes described (eg, 5+ genes, 5–50 genes, and larger panels).

See billing and coding sections for CPT and proprietary codes referenced.

All relevant CPT/HCPCS codes billed

Denial Risk

Large rearrangement (BART) testing — authorization & denial risk

BART (large rearrangement) testing billed with codes such as 81164, 81166, or 81167 may be denied as not covered when the medical necessity criteria for hereditary cancer testing are not met; prior authorization may be required per plan rules.

Codes called out: 81164, 81166, 81167

Prior Authorization

Prior authorization recommended for unlisted/potentially covered codes

All unlisted CPT/HCPCS codes and potentially covered services are subject to review; prior authorization is recommended for unlisted codes to avoid post-service denial.

Unlisted codes are reviewed for medical necessity, correct coding, and pricing at claim level
If an unlisted code is submitted for potentially covered services, prior authorization is recommended to avoid post-service denial

Step Therapy

Test affected relatives before unaffected members

When possible, order testing for affected family members first before testing unaffected individuals; if testing an unaffected member before an affected relative is necessary, document the reason in the pre-test counseling notes.

Document that affected relative testing could not be performed and explain limitations on interpreting results when testing an unaffected member first
Pre-test counseling notes should record rationale

Step Therapy

Order targeted testing when familial variant known

When a familial pathogenic/likely pathogenic variant is known in the family, testing must be specific to that familial variant (targeted testing) as recommended by NCCN.

Do not perform broad panel testing when a targeted familial-variant test is appropriate

Documentation Required

Document pre-test counseling and family testing status

Pre-test counseling must document that genetic counseling general criteria were met and, when possible, that affected family members were tested first; if affected members could not be tested, pre-test notes must explain why.

Document that genetic counseling occurred and how results will impact clinical decision-making
If affected relatives were not tested, include explanation in pre-test counseling notes

Documentation Required

Provide specified documentation with test requests

At the time of the test request, provide the specific gene or test name (or full gene list for custom tests), laboratory name, clinical notes including genetic counseling, prior related test results, family history, indication, and all relevant CPT/HCPCS codes.

Billing Rule

Bill panels with unlisted code when no specific code exists

When no specific CPT or HCPCS code exists for a panel, bill using an unlisted molecular pathology code; do not bill component tests separately as individual tests.

Billing panel components separately is inappropriate and may be considered misrepresentation or fraudulent billing

Billing Rule

Unlisted codes subject to claim-level review; prior auth recommended

All unlisted codes are reviewed at claim level for medical necessity, correct coding, and pricing; prior authorization is recommended for unlisted codes submitted for potentially covered services to avoid post-service denial.

Denial Risk

Denial triggers: unmet criteria, repeat testing, non-relevant genes

Tests will be considered not medically necessary (and are likely to be denied) when the policy’s coverage criteria I–III are not met, when repeat testing of the same genes is requested, or when ordered panels include genes without demonstrated clinical utility.

Repeat testing of the same genes is considered not medically necessary
Panels that include non-relevant genes without demonstrated utility are not supported

Denial Risk

Incomplete documentation may lead to denial

Failure to submit the complete documentation checklist (test name/genes, laboratory, clinical notes and counseling documentation, prior related test results, family history, and billed CPT/HCPCS codes) may adversely affect review and could trigger denial.

Denial Risk

Denial risk for large rearrangement (BART) testing

BART large rearrangement testing billed with 81164, 81166 and/or 81167 may be denied as not covered when the medical necessity criteria for hereditary breast/ovarian/pancreatic/prostate cancer testing are not met.

Denial Risk

Denial risk for unbundling panel tests

Billing individual tests from a panel separately (unbundling) instead of using an appropriate unlisted panel code when no specific panel code exists is inappropriate and may be subject to denial or considered fraudulent billing.

Denial Risk

Unlisted code submissions for non-covered services will be denied

If an unlisted code is submitted for services that this policy deems non-covered, the claim will be denied as not covered.

Documentation Required

Document genetic counseling before testing

Genetic counseling general criteria must be met prior to testing and must be documented in the pre-test counseling notes; documentation must explain how results will impact clinical decision-making.

Prior Authorization

Order testing after counseling and prefer affected-member testing first

Testing should follow documented genetic counseling and, when possible, be ordered for affected family members first; if affected members cannot be tested first, include documentation explaining why.

Documentation Required

Include clinical notes and counseling; ACOG-recognized providers may counsel

Include clinical notes and counseling documentation with test requests; ACOG recognizes obstetrician-gynecologists as qualified to counsel and order testing when appropriate.

Note

No explicit ordering-provider restrictions stated

No explicit restrictions on who may order testing are specified in the policy excerpts.

Denial Risk

Certain named multi-gene panels are not covered

Specific named multi-gene panels are listed in the policy as examples of tests considered not medically necessary; submitting unlisted codes for these non-covered services will result in denial.

Examples listed include +RNAinsight for BreastNext, BreastNext, CancerNext, myRisk Hereditary Cancer, Invitae panels, VistaSeq panels, and others

Denial Risk

Panels including genes lacking demonstrated clinical utility are not covered

Panels that include genes without demonstrated clinical utility for hereditary breast/ovarian/pancreatic/prostate cancer (e.g., some multi-gene panels) are not supported for cancer risk assessment and are not covered.

Denial Risk

Do not order panels with non-relevant genes for risk assessment

Panel testing that includes genes not identified as relevant to hereditary breast, ovarian, pancreatic, and/or prostate cancer is not supported for cancer risk assessment without additional evidence of analytic/clinical validity and utility.

Denial Risk

Unlisted code submissions for non-covered services will be denied

Unlisted codes submitted for non-covered services addressed in this policy will be denied as not covered; inclusion or omission of a code in the policy does not imply coverage.

Panels that include only genes with established clinical utility from the policy gene list (examples: select INVITAE hereditary panels) may be considered medically necessary when criteria are met.

PreferencePanels limited to genes with demonstrated clinical utility and high penetrance are preferred.

Close blood relatives — NCCN definition

Definition per NCCNClose blood relative: first- (parents, siblings, children), second- (grandparents, aunts, uncles, nieces, nephews, grandchildren, half-siblings), and third-degree relatives (great-grandparents, great-aunts, great-uncles, great-grandchildren and first cousins) on the same side of the family.

Same side of familyRelatives must be on the same side (maternal or paternal) when applying family-history criteria.

Examples providedPolicy lists representative relatives for first-, second-, and third-degree categories to guide pedigree construction.

Risk-reducing bilateral salpingo-oophorectomy — definition and timing

DefinitionRisk-reducing bilateral salpingo-oophorectomy: surgical removal of both ovaries and fallopian tubes with complete tissue removal and detailed pathology, including serial sectioning and pelvic washings.

Timing for BRCA1Typically recommended at age 35–40 years for BRCA1 carriers due to higher lifetime risk and earlier onset.

Timing for BRCA2Women with BRCA2 may consider delaying until age 40–45 years because of later onset of ovarian cancer.

Genetic counseling — recommendations and ACOG guidance

RecommendationGenetic counseling is recommended for all women with ovarian epithelial cancer and for individuals with a personal or family history of breast or ovarian cancer.

ACOG positionACOG opposes requirements that counseling be provided solely by a 'certified' genetic counselor and recognizes obstetrician-gynecologists as qualified to counsel patients.

DocumentationPre-test genetic counseling should be documented in clinical notes prior to testing per policy requirements.

Genomic sequence analysis panel (5+ genes) — definition

Test typeGenomic sequence analysis panel of 5 or more genes: interrogation for sequence variants and copy number variants.

Methods referencedNext-generation sequencing (NGS) and digital multiplex ligation-dependent probe amplification for variant and small indel detection (e.g., <40 bp).

Specimen typesTesting may use saliva, whole blood, or nail clipping as specimen sources per billing guidelines.

Solid organ neoplasm panel (5-50 genes) — definition

Panel definitionSolid organ neoplasm genomic sequence analysis panel, 5–50 genes: interrogation for sequence variants and copy number variants or rearrangements (DNA analysis or combined DNA/RNA analysis if performed).

Analytic scopeMay include evaluation for sequence variants, copy number variants, and rearrangements when applicable.

Panel use caseDescribed for solid organ neoplasm testing and aligns with panel groupings (5–50 genes) in billing guidelines.

Annual update broadened scope to address hereditary prostate cancer.

2025-01-01Interim update / code update

Interim update broadened policy scope to address hereditary pancreatic cancer and Q1 2025 code set update.

2024-08-01Interim update

Interim update expanded policy scope to address hereditary pancreatic cancer.

2024-07-01Annual review

Annual review and title change; added criterion to deny repeat testing and broadened scope to hereditary pancreatic cancer.

2024-01-01Code set update

Q1 2024 code set update applied to the policy.

2023-10-01Interim update

Interim update: Code moved to policy with no configuration changes.

2023-07-01Annual review

Annual review: Added BARD1 to genes associated with breast cancer and added +RNAinsight for BreastNext and OvaNext by Ambry Genetics to listed panels.

2023-03-01Interim update

Interim update: Denials for non-covered testing changed from 'investigational' to 'not medically necessary'.

2023-02-01Annual review

Annual review and conversion to new policy template; no clinical changes noted in this entry.