DraftUnitedHealthcarePolicy CS049NM.D

Genetic Testing for Hereditary Cancer (for New Mexico Only)

Policy governs coverage of germline genetic testing (single-gene, BRCA1/2, and multigene hereditary cancer panels, plus statements on RNA, polygenic risk scores, exome/genome) for members in New Mexico. It describes clinical indications, documentation requirements, and code references for ordering and review.

Policy Summary

PayerUnitedHealthcare

PolicyGenetic Testing for Hereditary Cancer (for New Mexico Only)

Policy CodePolicy CS049NM.D

Change TypeRevised coverage criteriacode updatesWES/WGS noncoverage stated

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionEnsure pretest genetic counseling is performed and submit pedigree and clinical documentation to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

Revised coverage criteria for multigene hereditary cancer panel testing for individuals with a personal history of a primary solid tumor, adding specific tumor types and renal cell carcinoma-related criteria.

Replaced risk-score tools listed for BRCA1/2 assessment: PENN11 and BRCAPro references were updated to BRCAPRO and CanRisk in selected thresholds.

Whole-exome and whole-genome sequencing for identifying hereditary cancer syndromes is stated as unproven and not medically necessary.

Updated Applicable Codes: removed CPT codes 0131U, 0132U, and 0135U and added multiple CPT/PLA codes for WES/WGS and panel testing.

Medical records documentation language was added clarifying documentation may be required to assess criteria and does not guarantee coverage.

NM only

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Coverage Criteria for Hereditary Cancer Testing

inv-01: Individuals with a personal history of a primary solid tumor

Covered when ANY of the following groups are met (personal history criteria OR family history criteria OR tumor/score findings):

Personal-history specific features: Individual has a personal history of at least one listed high-risk tumor feature (examples include: breast cancer diagnosed ≤50 years; metastatic breast cancer; multiple primary breast cancers; triple-negative breast cancer; lobular breast cancer with diffuse gastric cancer history; breast cancer with Ashkenazi Jewish ancestry; male breast cancer; breast cancer with unknown or limited family history; breast or prostate cancer with a first- or second-degree relative with a BRCA-related cancer; ovarian cancer (including fallopian tube or primary peritoneal cancer; sex-cord tumors with annular tubules; hypercalcemic-type small cell carcinoma of the ovary); serous tubal intraepithelial carcinoma; pancreatic cancer; metastatic prostate cancer; Lynch syndrome–associated cancer; neuroendocrine tumor (e.g., adrenocortical carcinoma, paraganglioma, pheochromocytoma); malignant phyllodes tumor; renal cell carcinoma with qualifiers (diagnosed ≤46 years; bilateral or multifocal tumors; first-/second-degree relative with RCC; personal/family history of mesothelioma or uveal melanoma; or specified hereditary RCC histologies); or at least two different primary solid tumors).

See chunks 4–6 for full enumerated list

Family-history within personal-history context: Individual has a personal history of a primary solid tumor plus a family history meeting at least one of: a close blood relative with a Lynch syndrome–associated cancer; a close blood relative diagnosed with a primary solid tumor ≤40 years; or at least two close blood relatives (in addition to the affected individual) on the same side of the family with primary solid tumors.

See chunk 5

Tumor or risk-score findings: Individual with a primary solid tumor and at least one of: a pathogenic variant detected in tumor tissue with clinical germline implications (examples: BRCA1/2, BRIP1, MLH1, MSH2, MSH6, MUTYH, PALB2, PMS2, RAD51C, RAD51D, RET, SDHx genes, TMEM127, TSC2, VHL, APC, PTEN, RB1, TP53); tumor MSI-high or loss of one or more MMR proteins (MLH1, MSH2, MSH6, PMS2); renal cell carcinoma with specified hereditary-associated histologies (multifocal papillary, FH-deficient/HLRCC-associated, Birt-Hogg-Dubé, angiomyolipomas plus another TSC criterion, SDH-deficient RCC); Tyrer-Cuzick, BRCAPRO, or CanRisk score ≥2.5% for BRCA1/2; or PREMM5/MMRpro/MMRpredict score ≥2.5% for Lynch genes.Tyrer-Cuzick/BRCAPRO/CanRisk >=2.5%; PREMM5/MMRpro/MMRpredict >=2.5%

See chunk 6

inv-02: Individuals with no personal history of a primary solid tumor

Covered when ANY one of the following family-history or risk-score criteria is met:

First-degree relative criteria: At least one first-degree relative with: two or more different primary solid tumors; a Lynch syndrome–associated cancer; or a neuroendocrine tumor (e.g., adrenocortical carcinoma, paraganglioma, pheochromocytoma). Alternatively, at least one first- or second-degree relative with breast cancer diagnosed ≤50, triple-negative breast cancer, male breast cancer, metastatic prostate cancer, ovarian cancer, or pancreatic cancer.

See chunk 7

Second-degree relative criteria: At least one second-degree relative with two or more Lynch-associated cancers or a Lynch-associated cancer diagnosed ≤50 years.

See chunk 7

Extended family patterns and special criteria: Family history meeting any of: two or more second-degree relatives on same side with Lynch-associated cancer; two or more first- or second-degree relatives on same side with RCC; three or more close blood relatives on same side with any primary solid tumor; Ashkenazi Jewish ancestry plus a close blood relative with a BRCA-related cancer; family member meeting polyposis diagnostic criteria but unwilling/unable to test; first-degree relative meeting RCC genetic-evaluation criteria but unwilling/unable to test; or personal colorectal polyposis with ≥10 adenomas.

inv-03: Pediatric cancer diagnosis

Covered indication

Cancer diagnosed <=18: Multigene hereditary cancer panels are medically necessary for individuals diagnosed with cancer at age 18 years or younger.

See chunk 8

inv-04: Not covered / unproven

Panels and technologies considered unproven: Multigene hereditary cancer panels, RNA panel testing for hereditary cancers, polygenic risk scoring for hereditary cancers, and whole-exome/whole-genome sequencing for identifying hereditary cancer syndromes are unproven and not medically necessary for indications not specifically covered in this policy.

See chunk 8

inv-05: Medical necessity criteria for hereditary cancer testing

Covered when ALL of the following are met

General coverage criteria: 1) Personal or family history consistent with hereditary cancer susceptibility documented by a detailed pedigree (first-, second-, and third-degree relatives with ages at diagnosis and cancer types); 2) Test results can be adequately interpreted clinically by the ordering team/laboratory; 3) Test results would influence diagnosis or medical management of the individual or at-risk family members (including cascade testing, screening, risk-reduction strategies, or therapy selection).

See chunks 20, 21, 22

Test modality selection: Appropriate testing modalities may include targeted/founder variant analysis, single-gene sequencing with deletion/duplication analysis (e.g., BRCA1/2), multigene hereditary cancer panels (>=5 genes), or exome/genome/transcriptome testing when clinically indicated; selection should reflect clinical suspicion to limit uncertain findings from very large panels.

See chunks 24 and 31

inv-06: Clinically Indicated Testing (NCCN-guided)

Covered when ANY of the following clinically indicated criteria per NCCN (v1.2026) are met or when specific guideline recommendations apply:

General clinically indicated situations (NCCN): Any blood relative with a known pathogenic/likely pathogenic variant; prior limited negative testing in a patient who meets criteria and desires MGPT; known P/LP on tumor testing with germline implications; testing to inform systemic therapy or surgical decision-making; meeting criteria for Li-Fraumeni, Cowden/PTEN hamartoma tumor syndrome, or Lynch syndrome.

See chunk 47

Breast cancer-specific indications: Personal history features per NCCN: diagnosed ≤50 years; testing to inform PARP/olaparib therapy; triple-negative histology; multiple primaries; lobular with diffuse gastric cancer history; male breast cancer; Ashkenazi Jewish ancestry; close relatives with early-onset breast/ovarian/pancreatic/prostate cancer; or unaffected patients with first- or second-degree relative meeting criteria or >5% BRCA1/2 probability (Tyrer-Cuzick, BRCAPRO, CanRisk).

See chunk 48

Ovarian cancer-specific indications: Personal history of epithelial ovarian (including fallopian tube or peritoneal) cancer at any age; specified nonepithelial ovarian histologies; unaffected patients with a first- or second-degree relative with epithelial ovarian cancer; or >5% BRCA1/2 probability by models.

inv-07: Professional Society Recommendations

ASCO/SSO and ASBrS recommendations to guide offering/testing:

ASCO/SSO breast cancer testing recommendations: Offer BRCA1/2 testing to patients ≤65 years with new breast cancer; offer to older patients if candidates for PARP inhibitors, triple-negative, personal/family history suggestive of a PV, male sex assigned at birth, or Ashkenazi Jewish ancestry; offer additional gene testing based on individual/family history; VUSs should not change management.

See chunks 44–45

ASBrS statements: Genetic testing should be accessible to patients with personal history of breast cancer; updated testing may benefit previously tested patients; testing in unaffected patients when NCCN criteria met; preferentially test an affected relative first when possible.

See chunk 41

inv-08: Supporting Evidence

Evidence from cohort and observational studies supporting MGPT use in selected populations:

TNBC cohort findings: MGPT detected pathogenic variants in genes associated with high TNBC risk (BARD1, BRCA1, BRCA2, PALB2, RAD51D) and moderate-risk genes (BRIP1, RAD51C, TP53); overall PV detection ~12%, supporting MGPT in TNBC.

See chunk 36

BRCA1/2-negative selected cohort: In women previously negative for BRCA1/2 but meeting additional criteria, MGPT identified pathogenic mutations in ~9% (8% non-BRCA genes), supporting subsequent MGPT when criteria are met.

See chunk 37

CRC MGPT cohort findings: Large CRC cohort MGPT found 14.2% with ≥1 P/LP variant and 9.1% with CRC/polyposis-risk variants; clinically actionable P/LP rate ≥7.9% across panel sizes though VUS rate high (~38.2%).

See chunk 55

inv-09: Germline MGPT panel gene-content criteria (NCCN)

Covered when ALL of the following are met for germline MGPT in CRC/EC per guideline-aligned recommendations

NCCN MGPT minimum gene inclusion: Panel includes at minimum the CRC-related genes (APC, MUTYH, MLH1, MSH2, MSH6, PMS2, EPCAM, BMPR1A, SMAD4, PTEN, STK11, TP53) when used for CRC testing; for EC panels include at minimum MLH1, MSH2, MSH6, PMS2, EPCAM, PTEN, and BRCA1/2. Use of genes beyond these should be based on age, phenotype, personal/family history, and patient/provider preference.

See chunk 61

inv-10: Lynch syndrome testing indications

Covered when ANY of the following Lynch syndrome testing criteria are met

Lynch syndrome testing indications: Known family Lynch syndrome pathogenic/likely pathogenic variant; personal history of an LS-related cancer diagnosed ≤49 years; synchronous/metachronous LS-related cancer at any age; first- or second-degree relative with LS-related cancer diagnosed ≤49 years; ≥2 first- or second-degree relatives with LS-related cancer regardless of age; model-based PREMM5/MMRpro/MMRpredict risk ≥5% (with some contexts using ≥2.5% as noted); tumor dMMR/MSI-high at any age; or personal history of a P/LP variant on tumor testing that could be germline.

See chunk 62

inv-11: Adenomatous polyposis testing indications

Covered when ANY of the following adenomatous polyposis criteria are met

Adenomatous polyposis criteria: Personal history of ≥20 cumulative adenomas; family history of a known pathogenic variant in an adenomatous polyposis gene; multifocal/bilateral congenital hypertrophy of the retinal pigment epithelium; personal history of cribriform-morular variant of papillary thyroid cancer; family history of polyposis with family unwilling/unable to undergo testing. Consider testing for 10–19 adenomas or other specific features per guideline discretion.

See chunk 64

inv-12: Hamartomatous polyposis testing indications

Covered when ANY of the following are met for hamartomatous polyposis or other gastrointestinal polyposis syndromes

Hamartomatous polyposis/Peutz-Jeghers/juvenile polyposis criteria: Two or more lifetime hamartomatous polyps; family history of hamartomatous polyps; cancer associated with hamartomatous polyposis in first- or second-degree relatives; two or more histologically confirmed Peutz-Jeghers polyps or any number with family history or mucocutaneous pigmentation; five or more juvenile colonic polyps or two or more juvenile polyps elsewhere or any number plus a first-degree relative with juvenile polyposis — genetic testing (MGPT) recommended when indicated.

See chunks 65–66

inv-13: PPGL testing indications

Covered when ANY of the following are met for PPGL (pheochromocytoma/paraganglioma)

PPGL testing indications: Clinical suspicion of hereditary PPGL in any affected individual given high heritability (~30–35%); features increasing likelihood include extra-adrenal disease, early onset, positive family history, multiple tumors, or metastatic disease. MGPT or comprehensive NGS panels are supported because limiting testing to only SDHB/C/D would miss a substantial proportion of PVs.

See chunks 68 and 71

inv-14: Solid tumor MGPT considerations

Consider germline MGPT in solid tumors when ALL of the following apply

Solid tumor universal/expanded testing considerations: Patient has a solid tumor (examples include pancreatic cancer or other tumor types) where studies show nontrivial pathogenic germline variant rates in unselected cohorts and where germline results may influence treatment selection, prognostication, clinical trial eligibility, or family counseling; testing should align with evidence and guideline recommendations for that tumor type.

See chunks 69–71

inv-15: Initial germline multigene testing

Covered when ALL of the following are met:

Core requirements: Patient has a confirmed cancer diagnosis or clinical scenario where germline testing is recommended by guideline (tumor-specific gene recommendations) AND a comprehensive family history is documented AND testing is expected to inform treatment, management, clinical trial eligibility, or familial risk assessment.

Based on ASCO and NCCN guideline recommendations (see chunks 76, 79)

Tumor-specific indications (examples): Meets at least one tumor-based criterion such as: pancreatic adenocarcinoma (germline panel recommended for all patients), prostate cancer where results could impact treatment or trial eligibility, pheochromocytoma/paraganglioma, renal cell carcinoma with early age onset or syndromic histology, neuroendocrine/adrenal tumors per NCCN/ASCO criteria.

See chunks 79, 84, 85, 87

Family/personal history indications: Close blood relative with known P/LP variant OR multiple first-/second-degree relatives with the same cancer OR early age at diagnosis or multiple primaries consistent with a hereditary syndrome.

Supported by NCCN/ASCO guidance (chunks 76, 83)

inv-16: Reflex and panel selection

Additional coverage considerations:

Tumor-to-germline reflex: When tumor testing identifies a pathogenic variant in specified genes (e.g., BRCA1/2, BRIP1, MLH1, MSH2, MSH6, MUTYH, PALB2, PMS2, RAD51C/D, RET, SDHx, TMEM127, TSC2, VHL, APC, PTEN, RB1, TP53), offer germline testing; ASCO further specifies offering germline testing when tumor PVs are found in listed genes and particularly in younger patients for certain genes.

See chunk 80

Panel composition: Panel should include at minimum the more strongly recommended genes for the patient’s tumor type; broader panels may be used when benefits outweigh harms; consider smaller panels initially when rapid results are needed for treatment decisions.

Per ASCO guidance in chunk 76

inv-17: Coverage considerations for PRS, RNA testing, and WES

Evidence-based considerations summarized from cited studies and guidance

PRS utility: Polygenic risk scores (PRS) demonstrate modest discrimination alone (e.g., pooled AUC ~0.63 for prostate cancer); combining PRS with clinical variables improves discrimination (AUC up to ~0.74). Clinical implementation should be cautious, with patient/provider discussion of limitations; ACMG does not support routine clinical implementation of PRS without thorough understanding of limitations.

See chunks 90, 91, 93

RNA testing with hereditary cancer panels: Concurrent RNA panel testing can clarify splicing variants and modestly increase diagnostic yield (example: 9.1% relative increase reported), but evidence quality is limited and the clinical impact is not fully established; more high-quality studies needed before routine concurrent use.

See chunk 94

Whole-exome/Exome+ screening: Exome+ screening can identify HBOC/LS carriers not meeting guideline criteria (e.g., 1.24% carrier rate in Tapestry cohort), detecting many previously undiagnosed carriers; limitations include under-detection of CNVs, population representation biases, and uncertain downstream clinical impact — further study required before broad population screening.

inv-18: Coverage criteria — Individuals with a personal history of a Primary Solid Tumor

Revised coverage criteria (examples shown) for individuals WITH and WITHOUT a personal history of a primary solid tumor

Individuals with a personal history of a Primary Solid Tumor: Coverage criteria revised to explicitly include serous tubal intraepithelial carcinoma and expanded renal cell carcinoma criteria: RCC diagnosed ≤46 years; bilateral/multifocal RCC; one or more first-/second-degree relatives with RCC; personal/family history of mesothelioma or uveal melanoma; and specified hereditary RCC histologies (multifocal papillary, HLRCC/FH-deficient features, Birt-Hogg-Dubé histology, angiomyolipomas plus additional TSC criterion, SDH-deficient RCC).

Extracted from revised coverage language (chunk 111)

inv-19: Coverage criteria — Individuals with no personal history of a Primary Solid Tumor

Individuals with no personal history of a Primary Solid Tumor

Individuals without a personal history: Revised criteria for individuals without a personal history require family history elements such as two or more first- or second-degree relatives on the same side with renal cell carcinoma or a first-degree relative who meets criteria for genetic evaluation for RCC but is unwilling/unable to undergo testing. BRCA1/2 risk-score model references for the 5% threshold were updated to Tyrer-Cuzick, BRCAPRO, or CanRisk.

See chunk 112

inv-20: Not medically necessary — WES/WGS for hereditary cancer

Whole-exome and whole-genome sequencing stance

WES/WGS for hereditary cancer syndrome identification: Whole-exome sequencing (WES) and whole-genome sequencing (WGS) for the purpose of identifying hereditary cancer syndromes or hereditary cancer syndrome risk are unproven and not medically necessary.

See chunk 111

This policy states that multigene hereditary cancer panels, RNA panel testing, polygenic risk scoring (PRS), and whole-exome/whole-genome sequencing (WES/WGS) are considered unproven and not medically necessary for indications that are not specifically covered by the policy. Concurrent RNA testing, PRS-based risk assessment, and exome/genome sequencing for identifying hereditary cancer syndromes are explicitly described as unproven and not medically necessary for routine use.

Broad population-based or universal multigene testing that includes many low-frequency or low-evidence genes for unselected individuals has limited utility. Large panels that include low- and moderate-penetrance genes may increase identification of variants of uncertain significance and findings that do not clearly change management, which can prompt unnecessary follow-up and procedures. Policy discussion cites population-level analyses showing that many genes on large panels have modest or no association with population-type disease, reducing the value of universal panel testing.

The policy does not support routine universal panel testing of all patients with cancer when panels include genes that lack evidence to support management changes. Professional guidance notes that while germline testing should be considered when clinically indicated, multigene panels containing genes without established clinical utility should be used cautiously and targeted per guideline recommendations rather than applied universally.

Consistent with USPSTF guidance, routine BRCA genetic counseling or BRCA1/2 testing is not recommended for women who do not have a personal or family history or ancestry associated with increased BRCA1/2 risk. Women with positive screening results should receive genetic counseling and, if indicated after counseling, testing; however routine testing of low-risk individuals is discouraged.

Polygenic risk scores (PRS) for hereditary cancer risk assessment are considered investigational and unsupported for routine clinical use because the evidence is currently insufficient. The policy highlights limitations in PRS performance and generalizability and advises that PRS alone does not provide adequate evidence to guide clinical hereditary cancer risk management.

The American College of Medical Genetics and Genomics (ACMG) cautions against routine clinical implementation of PRS without thorough understanding of limitations: a low PRS does not exclude significant risk, PRS may be poorly predictive in populations different from the derivation cohorts, and management decisions based on PRS require evidence-based plans and informed patient–provider discussions. ACMG does not support routine PRS implementation unless providers and patients understand these constraints.

Whole-exome sequencing (WES) and whole-genome sequencing (WGS) for the purpose of identifying hereditary cancer syndromes or hereditary cancer risk are stated as unproven and not medically necessary for routine clinical use. Although exome-based screening (Exome+) may detect carriers missed by guideline-directed testing in research cohorts, limitations—such as under-detection of copy-number variants and population representation biases—prevent routine coverage for hereditary cancer identification.

In summary, the policy does not support routine use of concurrent RNA panel testing, polygenic risk scoring (PRS), or WES/WGS with multigene hereditary cancer testing for general clinical practice. RNA testing may clarify some splicing variants and modestly increase diagnostic yield in specific studies, but evidence of downstream clinical impact is insufficient; PRS lacks demonstrated clinical utility for hereditary cancer risk management; and WES/WGS remain unproven for routine hereditary cancer syndrome identification.

Multigene panels that include genes with limited, disputed, or low-quality evidence of association with cancer should be used with caution. Panels that include many low-penetrance or low-frequency genes reduce the overall clinical utility of testing in unselected populations and increase the likelihood of variants of uncertain significance; such panel composition may not support changes in medical management and therefore is discouraged without documented clinical justification.

Routine genetic counseling or BRCA testing is not recommended for individuals without a relevant personal or family history or ancestry associated with increased BRCA1/2 risk. Screening tools and genetic counseling should be used to identify candidates; testing and counseling for low-risk, asymptomatic individuals without qualifying history is not supported by USPSTF guidance and this policy.

Using comprehensive multisyndrome or broad multisyndrome panels in individuals without syndrome‑specific indications has minimal expected benefit and limited evidence to support clinical management changes. Professional guidance recommends targeted gene analysis for the syndrome most likely responsible, reserving larger panels for cases where multiple syndromes are plausible or when benefits clearly outweigh the risks of uncertain findings.

Ordering broad multigene panels without documented clinical indication or appropriate family history may not be medically necessary due to increased detection of variants of uncertain significance and limited actionable findings. The policy emphasizes selecting panels driven by clinical phenotype, family history, or guideline-based indications to avoid unnecessary interventions prompted by uncertain results.

The policy concludes that broad concurrent use of RNA panels with DNA hereditary cancer panels is not supported for routine implementation because existing studies are limited in size and quality. Although some studies report a modest increase in diagnostic yield with RNA testing, prospective evidence demonstrating clinical impact and standardized interpretation is insufficient to recommend routine concurrent RNA testing.

Briefly: WES/WGS are not covered for routine identification of hereditary cancer syndromes. The policy explicitly states whole-exome and whole-genome sequencing for this purpose are unproven and not medically necessary.

Covered Indications and Specific Scenarios

inv-86: BRCA1/2 and multigene hereditary cancer panels when specified personal or family history criteria or tumor/risk-score findings are met

BRCA1/2 and MGPT when personal/family history or tumor/risk-score findings met: BRCA1/2 testing and multigene hereditary cancer panels are covered when the individual meets specified personal history criteria, specified family history patterns, or tumor/risk-score findings as enumerated in policy (examples include features in chunks 4–6).

See chunks 4–6 for specific criteria

inv-87: Personal or family history suggestive of hereditary cancer where testing could alter management.

Personal or family history suggestive of hereditary cancer: Personal or family history consistent with hereditary cancer (early onset, multiple primaries, bilateral disease, multiple affected relatives) where genetic testing could alter medical management, screening, or therapy decisions; testing modality tailored to suspected syndrome (targeted founder testing, single-gene, deletion/duplication analysis, or MGPT).

See chunks 20–21

Applicable CPT/PLA and Related Codes

BRCA and selected proprietary panel codesmixed

0138U	BRCA1 and BRCA2 mRNA sequence analysis (listed)
81162	BRCA1/BRCA2 gene analysis; full sequence and full duplication/deletion analysis
81163	BRCA1/BRCA2 gene analysis; full sequence analysis
81164	BRCA1/BRCA2 gene analysis; full duplication/deletion analysis
0101U	Hereditary colon cancer disorders panel (15 genes sequencing and deletion/duplication)
0102U	Hereditary breast cancer-related disorders panel (17 genes sequencing and deletion/duplication)
0103U	Hereditary ovarian cancer panel (24 genes)

Multi-gene panels, pan-cancer, exome/genome, and related codesmixed

0129U	Hereditary breast cancer-related disorders panel (ATM, BRCA1, BRCA2, CDH1, CHEK2, PALB2, PTEN, TP53)
0130U	Hereditary colon cancer targeted mRNA sequence analysis panel
0133U	Hereditary prostate cancer targeted mRNA panel (11 genes)
0134U	Hereditary pan cancer targeted mRNA panel (18 genes)
0162U	Hereditary colon cancer (Lynch) targeted mRNA panel (MLH1, MSH2, MSH6, PMS2)
0238U	Oncology (Lynch) genomic DNA sequence analysis including deletions/duplications and difficult regions
0474U	Hereditary pan-cancer 88-gene panel
0475U	Hereditary prostate cancer 23-gene panel
0495U	Oncology (prostate) circulating plasma proteins and germline polygenic risk score
81432	Hereditary breast cancer-related panel, 5 or more genes

1–10 of 26

1/3

WES/WGS and related unlisted codesmixed

0212U	Rare diseases whole genome and mitochondrial DNA sequence analysis (identification and characterization)
0213U	Whole genome and mitochondrial DNA sequence analysis each comparator genome
0214U	Whole exome and mitochondrial DNA sequence analysis, proband
0215U	Whole exome sequence analysis each comparator exome
0265U	Whole genome and mitochondrial DNA sequence analysis in various specimen types
0266U	Whole-transcriptome tissue-specific gene expression by next-generation sequencing
81479	Unlisted molecular pathology procedure. Whole Exome and Whole Genome Sequencing.

Exome/Genome CPT codesCPT

81415	Exome; sequence analysis
81416	Exome; sequence analysis, each comparator exome
81417	Exome; re-evaluation of previously obtained exome sequence
81425	Genome; sequence analysis
81426	Genome; sequence analysis, each comparator genome
81427	Genome; re-evaluation of previously obtained genome sequence

Applicable CPT/PLA codes added for WES/WGS and panelsCPT

0212U
0213U
0214U
0215U
0265U
0266U
81415
81416
81417
81425

1–10 of 12

1/2

CPT codes removedCPT

0131U
0132U
0135U

Multigene panel — gene count definition

Multigene panel definitionNext-generation sequencing tests that analyze multiple genes simultaneously; for this policy a multigene panel consists of five or more genes.

BRCA1/2 risk score thresholds

BRCA1/2 risk-score thresholds (affected individuals)Use Tyrer‑Cuzick, BRCAPRO, or CanRisk — threshold: ≥2.5% probability for a BRCA1/2 pathogenic variant.

BRCA1/2 risk-score thresholds (unaffected individuals)Use Tyrer‑Cuzick, BRCAPRO, or CanRisk — threshold: ≥5% probability for a BRCA1/2 pathogenic variant.

Risk models referencedAcceptable models named in policy: Tyrer‑Cuzick, BRCAPRO, CanRisk; policy replaced prior PENN11/BRCAPro wording with BRCAPRO and CanRisk updates.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required When Testing Meets Guideline-Based Indications

Prior authorization (PA) may be required when genetic testing meets guideline‑based indications. Prior authorization should demonstrate that testing is ordered for clinically indicated reasons per current professional society guidelines (for example NCCN, ASCO) — e.g., personal or family history meeting testing criteria, impact on systemic therapy/surgical decisions, or a known pathogenic/likely pathogenic (P/LP) variant in a relative or tumor test with germline implications.

PA is likely required to document guideline-based indication(s) and clinical intent.
Provide copies of guideline-relevant findings (tumor results, prior genetic testing reports) when applicable.

Documentation Required

Panel Composition Requirement for CRC/EC Germline MGPT

When ordering germline multigene panels for colorectal cancer (CRC) or endometrial cancer (EC), the panel must include, at minimum, the NCCN‑specified CRC‑ or EC‑related genes. If a selected commercial panel does not include these genes, document clinical rationale for why the panel is appropriate.

Definitions and Terminology

Multigene Panel — definition (policy)

Multigene panel (NGS) descriptionGenetic tests using next‑generation sequencing to assess multiple genes simultaneously; also called multigene or multiple‑gene panel tests.

Policy threshold for panel sizeFor this policy, multigene panels consist of five or more genes.

Eligibility Requirements and Documentation

To be eligible for coverage under the policy, requests for hereditary cancer testing must include contemporaneous documentation of the patient’s personal and family cancer history presented as a pedigree drawing/diagram using standardized nomenclature. Documentation should detail first‑degree, second‑degree, and relevant third‑degree relatives with ages at diagnosis, cancer primary sites, bilateral disease, and current age or age at death; this comprehensive pedigree is used to establish whether the family history meets the clinical criteria required for testing.

The policy requires submission of a detailed family and personal history—preferably a pedigree—within the medical record to support medical necessity. Records should include ages at diagnosis, relationship of affected relatives (first-, second-, third-degree), tumor types, bilateral disease, and any known pathogenic variants in family members to allow reviewers to determine if established criteria are met.

Pedigree documentation is required in contemporaneous medical records and should use standardized nomenclature. The pedigree must include sufficient detail on first- and second-degree relatives (and when relevant third-degree relatives) including ages at diagnosis and cancer sites to support the clinical rationale for testing.

The policy references guideline-based family-history nodes (e.g., Lynch syndrome criteria) and expects pedigree detail sufficient to apply established models and criteria; reviewers will use submitted clinical documentation and predictive model results to evaluate eligibility. Specific top-level procedural nodes are not repeated here but the referenced guideline criteria (e.g., PREMM5/MMRpro thresholds) apply when assessing family history.

No additional top-level eligibility nodes are provided in this block; family-history documentation requirements and guideline-referenced thresholds (for example for Lynch syndrome predictive models) are used to determine eligibility when applicable. Reviewers should reference the stated model thresholds and family-history rules when assessing requests.

Not Covered / Investigational Services

This policy section states that multigene hereditary cancer panels, RNA panel testing, polygenic risk scoring, and whole-exome/whole-genome sequencing are considered unproven and not covered for routine use when requested for indications not explicitly supported by the coverage criteria. Requests for these technologies should be justified by the clinical criteria outlined in the policy.

Routine universal population-based multigene testing that includes many low-frequency or low-evidence genes in unselected individuals is not covered because its clinical utility is limited. Evidence from population-based analyses shows many genes on broad panels have low pathogenic variant frequencies and modest associations, reducing benefit from universal implementation.

Routine population-based or universal panel testing of individuals without qualifying personal or family history or ancestry-associated risk is not supported. Professional guidance and USPSTF recommendations emphasize targeted screening and genetic counseling to identify individuals who should be tested rather than broad population-level panel testing.

Comprehensive multisyndrome panel testing used to detect or manage individuals without syndrome‑specific indications lacks supportive evidence and is not covered in such contexts. The literature review identified minimal evidence that multisyndrome panels improve clinical management when syndrome-specific indications are absent.

Use of polygenic risk scores (PRS) for routine hereditary cancer risk assessment is not covered due to insufficient evidence of clinical utility and concerns about generalizability and management implications. ACMG guidance stresses limitations and recommends against routine clinical implementation without clear evidence-based management pathways.

Background and Evidence Summary

The policy strongly recommends pretest genetic counseling and emphasizes that ordering providers should ensure counseling is performed and that medical records submitted with testing requests fully support medical necessity. Lack of adequate documentation may lead to denial; documentation should include a pedigree and pertinent clinical details to demonstrate that patients meet coverage criteria.

Revision History and Policy Changes

2026-05-01coverage_criteria_revision

Revised coverage criteria to add specific tumor triggers including serous tubal intraepithelial carcinoma and expanded renal cell carcinoma criteria (age ≤46, bilateral/multifocal, family history, mesothelioma/uveal melanoma, and specified histologies).

2026-05-01risk_model_update

Updated referenced risk models for BRCA1/2 thresholds: replaced PENN11 with CanRisk and standardized BRCAPRO mention for 2.5% and 5% thresholds.

2026-05-01not_medically_necessary_statement

Policy Summary

PayerUnitedHealthcare

PolicyGenetic Testing for Hereditary Cancer (for New Mexico Only)

Policy CodePolicy CS049NM.D

Change TypeRevised coverage criteriacode updatesWES/WGS noncoverage stated

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionEnsure pretest genetic counseling is performed and submit pedigree and clinical documentation to support medical necessity.

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inv-88: Clinically indicated testing per NCCN criteria for personal or family history of hereditary cancer syndromes, testing to inform therapy/surgery, prior limited negative testing meeting criteria, or known tumor P/LP variant with germline implications.

NCCN-guided clinically indicated testing: Clinically indicated testing per NCCN includes: known family P/LP variant; prior limited/negative testing when criteria present and MGPT desired; tumor-detected P/LP variant with germline implications; testing to inform systemic/surgical therapy; meeting testing criteria for Li-Fraumeni, Cowden/PTEN, or Lynch syndromes; and tumor- or cancer-type specific indications (breast, ovarian, pancreatic, prostate) as detailed in NCCN guidance.

See chunks 47, 48, 50–52

inv-89: Individuals meeting guideline-based criteria for Lynch syndrome, adenomatous polyposis, hamartomatous polyposis, PPGL, pancreatic cancer, CRC/EC with appropriate features, or known family pathogenic variant.

Guideline-based syndrome-specific indications: Individuals meeting guideline-based criteria for Lynch syndrome, adenomatous polyposis, hamartomatous polyposis, PPGL, pancreatic cancer, CRC/EC with appropriate features, or having a known family pathogenic variant are eligible for germline testing; NCCN specifies minimum gene content for CRC/EC panels and recommends MGPT when indicated.

See chunks 61–62, 64–65, 68

inv-90: Germline multigene panel testing for patients with cancer when guideline-based tumor-specific or family-history criteria are met (examples: breast, colorectal, endometrial, ovarian, pancreatic, prostate, PPGL, RCC, NET).

Tumor-specific MGPT when guideline criteria met: Germline multigene panel testing is covered for patients with cancer when guideline-based tumor-specific or family-history criteria are met (examples: breast, colorectal, endometrial, ovarian, pancreatic, prostate, pheochromocytoma/paraganglioma, renal cell carcinoma, neuroendocrine tumors) and panels should include recommended genes for the tumor type.

See chunks 76, 79, 83–87

inv-91: Detection of HBOC and Lynch syndrome carriers via exome-based screening (Exome+) in population or cohort genomic screening studies — context and limitations.

Exome+ detection context: Exome-based screening (Exome+) in population or cohort genomic screening can detect HBOC and Lynch syndrome carriers not meeting NCCN criteria; while it identifies additional carriers, limitations include representation biases and under-detection of CNVs, and broader implementation requires further study.

See chunk 96

inv-92: Multigene hereditary cancer panel or BRCA1/2 testing for individuals meeting revised personal or family history criteria, including newly specified RCC and ovarian cancer subtype examples.

Revised personal/family history criteria (including RCC and ovarian subtypes): Multigene hereditary cancer panel or BRCA1/2 testing is covered for individuals meeting revised personal or family history criteria, incorporating newly specified renal cell carcinoma examples (age ≤46, bilateral/multifocal, family history, mesothelioma/uveal melanoma, specific histologies) and expanded ovarian cancer subtype examples; BRCA risk-model thresholds retained with model names updated (Tyrer-Cuzick, BRCAPRO, CanRisk).

See chunks 111–112

Prior Authorization

Prior Authorization May Apply for Added WES/WGS and Panel Codes

Certain newly listed CPT/PLA codes for whole‑exome/whole‑genome sequencing (WES/WGS), exome‑based panels, and related PLA codes have been added to the applicable codes list and may be subject to prior authorization. When requesting WES/WGS or exome‑based population screening (e.g., Exome+), submit clinical justification and documentation showing why less broad, guideline‑directed testing was not appropriate or sufficient.

Examples of relevant codes added: 0212U, 0213U, 0214U, 0215U, 0265U, 0266U, 81415–81417, 81425–81427 (see Applicable Codes section for full descriptions).
Document why WES/WGS or Exome+ would change management or is indicated (e.g., unexplained syndromic presentation, prior negative targeted testing in affected relative).

Denial Risk

Testing Limited to Genes With Clinical Utility

Order testing limited to genes with demonstrated clinical utility for the patient’s phenotype and management. Avoid broad panels that include genes lacking evidence that a P/LP finding would change clinical care unless specific, documented reasons support broader testing.

If a panel includes low‑ or moderate‑risk genes with unclear management implications, document the expected clinical benefit and how uncertain results will be managed.
Use phenotype‑directed panels when a focused syndrome is most likely; broader testing may be considered when multiple syndromes are plausible.

Prior Authorization

Coverage Contingent on Meeting Guideline Criteria

Coverage for genetic testing is contingent on meeting the listed guideline criteria and applicable contractual, state, or federal requirements. Absence of documented guideline criteria or insufficient medical record support may result in denial of the request.

Coverage decisions follow federal/state/contractual rules — inclusion of a code in this policy does not guarantee coverage.
If clinical criteria are not met, document why testing is still medically necessary and how results will affect management.

Documentation Required

Required Family/Personal History Documentation

Provide contemporaneous personal and family history documentation with the testing request. A pedigree diagram using standardized nomenclature should be included in the medical record and submitted with the prior authorization or test requisition.

Pedigree should include first‑, second‑, and third‑degree relatives with ages at diagnosis or current ages/age at death.
Document bilateral disease, multiple primaries, tumor histology, and ancestry when relevant.

Documentation Required

Required Clinical Documentation to Support Medical Necessity

Required clinical documentation must accompany test requests to support medical necessity. This includes relevant medical history, focused physical exam findings, tumor pathology/histology (when applicable), prior genetic or tumor testing results, and descriptions of how results will influence management.

Include prior genetic testing reports (with methods and scope) and tumor genomic findings if germline implication is a concern.
Supply documentation of treatment‑impact rationale (e.g., systemic therapy decisions, surgical planning) when testing is ordered to guide therapy.

Documentation Required

Genetic Counseling Documentation

Document that genetic counseling (pretest and, when applicable, posttest) occurred or was offered. Counseling should be performed by a certified genetic counselor or provider with expertise in cancer genetics, or documentation should note why an alternative qualified provider performed counseling.

Record topics covered: test purpose, benefits/limitations, potential outcomes (including VUS), psychosocial considerations, and cascade testing implications.
If counseling was deferred, document reason and confirm informed consent was obtained.

Documentation Required

Panel Selection Rationale

Provide a rationale for the selected multigene panel tied to the patient's age, phenotype, personal and family cancer history, and any tumor findings. The ordering clinician should justify panel choice and how included genes relate to the clinical presentation.

If ordering a broader panel beyond guideline‑recommended genes, document why broader testing is anticipated to yield actionable results.
When turnaround time or immediate treatment decisions are priorities, document plan for stepwise testing (smaller to larger panels) if appropriate.

Documentation Required

Medical Records Required to Support Medical Necessity

The patient's medical record must fully support medical necessity for the requested testing. Records should be legible, contemporaneous, and include the information needed to substantiate the PA request; failure to provide adequate records may lead to denial.

Maintain and provide: pedigree, clinical notes, tumor pathology, prior testing results, and documented genetic counseling notes.
Ensure records are available upon request and clearly tie test selection to clinical management.

Step Therapy

Stepwise Testing Consideration and Step Approach to Panel Size

Consider a stepwise/tiered testing approach when clinically appropriate: start with targeted single‑gene or small phenotype‑directed panels if that is most likely to identify the causative mutation, reserving broader panels for situations with multiple syndromic possibilities or when initial testing is negative but clinical suspicion remains.

Smaller panels may be used initially when rapid results are necessary for treatment decisions; broader panels can follow if indicated.
Document why stepwise testing is chosen and how results of each stage will affect subsequent care.

Note

Test Affected Relative First When Possible

When possible, test an affected relative first. Testing an affected family member increases the likelihood of identifying a clinically informative variant and can reduce unnecessary testing in unaffected relatives.

Document availability of affected relatives for testing and whether targeted familial variant testing of an unaffected individual is appropriate based on results.
If an affected relative cannot be tested, document rationale for testing an unaffected individual and limitations of interpretation.

Prior Authorization

Consider Guideline‑Directed Targeted Testing First; Document Rationale for RNA/Exome Requests

Before ordering population‑level exome sequencing or Exome+ for hereditary breast/ovarian cancer (HBOC) or Lynch Syndrome (LS) screening, consider and document that guideline‑directed targeted testing was reviewed and why it was not appropriate. For RNA panel testing concurrent with DNA panels, document clinical rationale and expected impact on management because evidence is limited.

If concurrent RNA testing or population exome is ordered, supply documentation showing how the additional data will change clinical management.
For Exome+/population screening, include documentation assessing detection limitations (e.g., CNV detection gaps) and how results will be followed up.