CurrentUnitedHealthcarePolicy CS049KY.13

Genetic Testing Hereditary Cancer Ky Cs

UnitedHealthcare medical policy CS049KY.13 governing coverage criteria for genetic testing for hereditary cancer in Kentucky, including single-gene, BRCA1/2, and multi-gene hereditary cancer panels; definitions, evidence summary, and applicable procedure codes (part 1 of 4).

Policy Summary

PayerUnitedHealthcare

PolicyGenetic Testing Hereditary Cancer Ky Cs

Policy CodePolicy CS049KY.13

Change TypeMaterial revision (criteria revisedadditions/exclusions)

Effective DateJun 1, 2025

Next Review Date

Key ActionPre-test genetic counseling is strongly recommended and documentation of counseling should be included with testing requests when applicable.

SourceLink

POLICY UPDATE CHANGES

06/01/2025 revision: replaced various coverage criteria phrasing and revised criteria for multi-gene hereditary cancer panel coverage for individuals with and without a personal history of a primary solid tumor.

06/01/2025 revision: added language that BRCA1/2 gene testing is proven and medically necessary for individuals with breast cancer diagnosed at age 65 or younger.

06/01/2025 revision: added CPT code 0495U to applicable codes.

06/01/2025 revision: added statement that genetic testing for polygenic risk scoring is unproven/not medically necessary.

06/01/2025 revision: updated Description of Services, Clinical Evidence, FDA, and References sections to reflect current information.

MultipleCovered Indications (listed criteria)

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Coverage Summary & Scope

UnitedHealthcare medical policy CS049KY.13 (effective June 1, 2025) governs genetic testing for hereditary cancer in Kentucky. The policy covers single-gene testing, BRCA1/2 testing, and multi-gene hereditary cancer panels and provides definitions, evidence summaries, and a list of applicable procedure codes.

Coverage stance is mixed: certain indications are covered (clinical criteria listed for single-gene, BRCA1/2, and multi-gene panel testing) while other uses (e.g., concurrent RNA panels for routine use and genetic testing for polygenic risk scoring) are stated as not medically necessary / unproven.

At a high level, the policy deems single-gene testing and known familial mutation testing proven and medically necessary; BRCA1/2 testing is established as medically necessary for individuals with breast cancer diagnosed at age 65 or younger; and multi-gene hereditary cancer panels are medically necessary when specified personal- or family-history criteria, tumor findings, or validated risk-score thresholds are met. The policy explicitly excludes routine use of RNA panel testing and polygenic risk scoring (PRS) from coverage.

Quick thresholds (tests/scores/age/adenomas)

BRCA/BRCAPro/Tyrer‑Cuzick/Penn11 threshold (with personal cancer)>= 2.5%

BRCA/BRCAPro/Tyrer‑Cuzick/Penn11 threshold (no personal cancer)>= 5%

Lynch (PREMM5/MMRpro/MMRpredict) threshold (with personal cancer)>= 2.5%

Lynch (PREMM5/MMRpro/MMRpredict) threshold (no personal cancer)>= 5%

Adenomatous polyposis adenoma count>= 20 cumulative adenomas (recommended); 10–19 consider testing

Age thresholds — breast cancer testing<= 50 years (high‑risk indication); offer BRCA1/2 for newly diagnosed <=65 years

Medical-Necessity Criteria (detailed decision trees)

General prerequisites

Covered when ALL of the following general prerequisites are met:

Pre-test genetic counseling is strongly recommended to inform the individual about the potential benefits, limitations, and implications of testing.

Testing is ordered by or in consultation with a clinician with appropriate expertise in genetics or a clinician who documents consultation with genetics expertise.

Testing is expected to influence clinical management, cascade family testing, or reproductive planning.

Single gene and known mutation testing

Single-gene and known familial mutation testing is considered medically necessary when ANY of the following are met:

Single gene testing is appropriate when the clinical presentation strongly suggests a single-gene disorder and targeted testing will provide actionable results.

Not Medically Necessary / Unproven Testing

Unproven/Not Medically Necessary (exclusions subset)

Exclusions subset: RNA panel testing for hereditary cancers is unproven and not medically necessary for all indications.

Exclusions subset: Genetic testing for the purpose of polygenic risk scoring for hereditary cancers is unproven and not medically necessary for all indications.

Exclusions subset: Multi-Gene hereditary cancer Panels are unproven and not medically necessary for indications not meeting policy criteria (i.e., for other indications).

Applicable Procedure and Panel Codes

BRCA1/BRCA2 specific and mRNA sequence analysis (listed examples)CPT|other

0138U	BRCA1 and BRCA2 mRNA sequence analysis (list separately)
81162	BRCA1/BRCA2 gene analysis; full sequence analysis and full duplication/deletion analysis
81163	BRCA1/BRCA2 gene analysis; full sequence analysis
81164	BRCA1/BRCA2 gene analysis; full duplication/deletion analysis

Multi-Gene Panel (specific U-codes and 814xx)CPT|other

0101U	Hereditary colon cancer disorders genomic sequence analysis panel (15 genes + EPCAM/GREM1 del/dup)
0102U	Hereditary breast cancer-related disorders genomic sequence analysis panel (17 genes)
0103U	Hereditary ovarian cancer genomic sequence analysis panel (24 genes + EPCAM del/dup)
0129U	Hereditary breast cancer-related genomic sequence and del/dup analysis panel (ATM, BRCA1, BRCA2, CDH1, CHEK2, PALB2, PTEN, TP53)
0130U	Hereditary colon cancer targeted mRNA sequence analysis panel (APC, CDH1, CHEK2, MLH1, MSH2, MSH6, MUTYH, PMS2, PTEN, TP53)
0131U	Hereditary breast cancer targeted mRNA sequence analysis panel (13 genes)
0132U	Hereditary ovarian cancer targeted mRNA sequence analysis panel (17 genes)
0133U	Hereditary prostate cancer targeted mRNA sequence analysis panel (11 genes)
0134U	Hereditary pan cancer targeted mRNA sequence analysis panel (18 genes)
0135U	Hereditary gynecological cancer targeted mRNA sequence analysis panel (12 genes)

1–10 of 20

1/2

Genes/minimum panels recommended (NCCN minimum gene lists)mixed

BRCA1	High-penetrance breast/ovarian gene
BRCA2	High-penetrance breast/ovarian gene
RAD51C	Ovarian cancer susceptibility gene
RAD51D	Ovarian cancer susceptibility gene
BRIP1	Ovarian cancer susceptibility gene
MLH1	MMR gene (Lynch syndrome)
MSH2	MMR gene (Lynch syndrome)
MSH6	MMR gene (Lynch syndrome)
PMS2	MMR gene (Lynch syndrome)
PALB2	Breast cancer susceptibility gene

1–10 of 25

1/3

Genes / gene lists referenced (by indication)mixed

BRCA1	Breast cancer susceptibility gene
BRCA2	Breast cancer susceptibility gene
PALB2
CDH1
PTEN
STK11
TP53
ATM
BARD1
CHEK2

1–10 of 63

1/7

Added CPT codeCPT

0495U

CPT code added to policy (description not provided in this part)

Provider Actions & Documentation Requirements

Documentation Required

Pre-test genetic counseling

Document that pre-test genetic counseling was provided and include counseling documentation with testing requests. Counseling should cover the purpose, benefits, limitations, possible results (including variants of uncertain significance), and potential implications for medical management and family members.

Include a note in the contemporaneous medical record that counseling occurred and attach or reference any counseling visit summary when submitting testing requests.

Documentation Required

Family history pedigree

Provide a pedigree (family history diagram) using standardized nomenclature and retain it in the contemporaneous medical record. The pedigree should be submitted with the testing request.

Pedigree must document at minimum first- and second-degree relatives, ages at diagnosis, cancer types, and vital status when known.

Background, Evidence Summary, and Definitions

Rationale: an estimated 5–10% of cancers are hereditary, so genetic testing can identify individuals with inherited cancer risk who may benefit from altered management or cascade testing of relatives.

Family history, comprehensive personal history, validated risk models, and tumor testing findings guide appropriate test selection because they improve the pre-test probability that a clinically actionable germline pathogenic/likely pathogenic (P/LP) variant will be found.

Risk scores and models (e.g., Tyrer-Cuzick, BRCAPro, PREMM5, MMRpro) and tumor-based markers (e.g., MSI-high or absent MMR protein IHC, tumor-detected P/LP variants) are used as triggers for germline testing per the policy.

Clinical utility: multi-gene panels can detect P/LP variants beyond BRCA1/2 that may change treatment or surveillance in a subset of patients, but broader panels also identify many variants of uncertain significance (VUS) and genes with limited evidence, which can cause potential harms such as unnecessary follow-up, anxiety, or interventions.

Therefore, the policy balances benefit and potential harms by recommending panel testing when specific clinical criteria or thresholds are met and by discouraging routine broad or unselected use that could lead to uncertain results.

Evidence / Metric	Value
BRCA cumulative breast cancer risk (BRCA1)
60%-72% lifetime risk (women with pathogenic BRCA1)
BRCA cumulative breast cancer risk (BRCA2)
55%-69% lifetime risk (women with pathogenic BRCA2)
BRCA cumulative ovarian cancer risk by age 70
BRCA1 ~48.3%; BRCA2 ~20%
Estimated proportion of cancers that are hereditary
~5-10% of all cancers are hereditary
Role of family history, risk scores, and tumor findings
Used to guide testing; tests recommended when personal/family history suggests hereditary susceptibility and results can influence management
Potential harms of broad multi-gene panels
May identify low/moderate-risk genes and VUS leading to uncertain clinical significance and unnecessary follow-up

Age Guidelines: for age-based criteria, a person is considered to be 45 until the day before their 46th birthday, and 50 until the day before their 51st birthday.

BRCA-Related Cancers: includes Breast Cancer, Ovarian Cancer (fallopian tube cancer/primary peritoneal cancer), pancreatic cancer, and prostate cancer.

Close Blood Relatives: first-degree = parents, siblings, offspring; second-degree = half-siblings, aunts/uncles, grandparents, grandchildren, nieces/nephews affected on same side; third-degree = first cousins, great-aunts/uncles, great-grandchildren, great-grandparents affected on same side.

Revision History

06/01/2025material_revisionLatest

Replaced wording across multiple coverage criteria (examples: changed phrasing for individuals assigned male at birth; clarified inclusion of prostate cancer in family-history BRCA-related criteria; expanded/standardized tumor-type language and clarified tumor-tissue pathogenic variant examples); revised multi-gene hereditary cancer panel coverage criteria for individuals with and without a personal history of a Primary Solid Tumor.

06/01/2025added_coverageLatest

Added statement that BRCA1/2 gene testing is proven and medically necessary for individuals with breast cancer diagnosed at age 65 or younger.

Policy Summary

PayerUnitedHealthcare

PolicyGenetic Testing Hereditary Cancer Ky Cs

Policy CodePolicy CS049KY.13

Change TypeMaterial revision (criteria revisedadditions/exclusions)

Effective DateJun 1, 2025

Next Review Date

Key ActionPre-test genetic counseling is strongly recommended and documentation of counseling should be included with testing requests when applicable.

SourceLink

On This Page

Multi-gene hereditary cancer panel testing - individuals with personal history of a Primary Solid Tumor

Multi-gene hereditary cancer panel testing is proven and medically necessary for individuals with a personal history of a Primary Solid Tumor (excluding basal or squamous cell skin cancer) when ONE of the following personal history criteria is met:

Breast Cancer diagnosed at age 50 years or younger

Metastatic Breast Cancer

Multiple primary Breast Cancers (including bilateral primary cancers)

Triple-Negative Breast Cancer

Lobular Breast Cancer with a personal or family history of diffuse gastric cancer

Breast Cancer in an individual of Ashkenazi Jewish ancestry

Breast Cancer in an individual assigned male at birth

Breast Cancer with unknown or limited family history

Breast Cancer or Prostate Cancer with at least one first- or second-degree relative with a BRCA-related cancer

Ovarian Cancer (including fallopian tube or primary peritoneal cancer)

Pancreatic Cancer

Metastatic Prostate Cancer

Cancer associated with Lynch syndrome

Neuroendocrine tumor (e.g., adrenocortical carcinoma, paraganglioma, pheochromocytoma)

Malignant phyllodes tumor

At least two different Primary Solid Tumors (excluding basal or squamous cell skin cancer)

Multi-gene panel testing - personal history plus family history criteria

For individuals with a personal history of a Primary Solid Tumor (excluding basal or squamous cell skin cancer), multi-gene panel testing is also proven and medically necessary when ANY of the following family history or tumor/score-based criteria are met:

At least one Close Blood Relative with a cancer associated with Lynch syndrome

At least one Close Blood Relative diagnosed with a Primary Solid Tumor at age 40 years or younger

At least two Close Blood Relatives (in addition to the affected individual) on the same side of the family diagnosed with any Primary Solid Tumor

A pathogenic variant was detected in tumor tissue that has clinical implications if present in the germline (examples: BRCA1, BRCA2, BRIP1, MLH1, MSH2, MSH6, MUTYH, PALB2, PMS2, RAD51C, RAD51D, RET, SDHAF2, SDHB, SDHC, SDHD, TMEM127, TSC2, VHL, APC, PTEN, RB1, TP53)

Tumor testing demonstrating MSI-high or loss of one or more MMR proteins (MLH1, MSH2, MSH6, PMS2) by IHC

Tyrer-Cuzick, BRCAPRO, or PennII score >= 2.5% for BRCA1/2

PREMM5, MMRpro, or MMRpredict score >= 2.5% for Lynch syndrome

Multi-gene panel or BRCA1/2 testing - tumor findings, scores, and other triggers

Multi-gene panel testing or BRCA1/2 testing is considered medically necessary based on tumor findings, MSI/dMMR, or empiric risk scores as follows:

Tumor pathogenic or likely pathogenic variant reported that has potential germline implication (see list of example genes in related criteria).

Tumor testing showing MSI-high or deficient mismatch repair (dMMR) by IHC indicating possible Lynch syndrome.

Prior-probability model thresholds: Tyrer-Cuzick, BRCAPRO, or PennII score threshold badges:

PREMM5, MMRpro, or MMRpredict score threshold badges:

Multi-gene hereditary cancer panel testing - individuals with no personal history

For individuals with no personal history of a Primary Solid Tumor (excluding basal or squamous cell skin cancer), multi-gene panel or BRCA1/2 testing is proven and medically necessary when ANY of the following family-history or score-based criteria are met:

At least one first-degree relative with either two or more different Primary Solid Tumors, a cancer associated with Lynch syndrome, or a neuroendocrine tumor (e.g., adrenocortical carcinoma, paraganglioma, pheochromocytoma).

At least one first- or second-degree relative with breast cancer diagnosed at age 50 years or younger, triple-negative breast cancer, breast cancer in a relative assigned male at birth, metastatic prostate cancer, ovarian cancer (including fallopian tube or primary peritoneal), or pancreatic cancer.

At least one second-degree relative with either two or more cancers associated with Lynch syndrome or Lynch-associated cancer diagnosed at age 50 years or younger.

Family history with at least two second-degree relatives on the same side of the family with cancers associated with Lynch syndrome.

At least three Close Blood Relatives on the same side of the family diagnosed with any Primary Solid Tumor.

Ashkenazi Jewish ancestry plus at least one Close Blood Relative with a BRCA-related cancer.

A family member meeting diagnostic criteria for polyposis (personal history of ≥10 cumulative adenomas) when the affected family member is unwilling or unable to have genetic testing.

Personal history of colorectal polyposis with at least ten adenomas.

Tyrer-Cuzick, BRCAPRO, or PennII score >= 5% for BRCA1/2.

PREMM5, MMRpro, or MMRpredict score >= 5% for Lynch syndrome.

Special populations and exclusions

Special population rules and explicit exclusions:

Genetic testing with a multi-gene hereditary cancer panel is proven and medically necessary for individuals diagnosed with cancer at age 18 years or younger to establish a diagnosis and guide management.

Multi-gene hereditary cancer panels are unproven and not medically necessary for all other indications not explicitly listed as medically necessary.

RNA panel testing for hereditary cancers is unproven and not medically necessary for all indications.

Genetic testing for the purpose of polygenic risk scoring (PRS) for hereditary cancers is unproven and not medically necessary for all indications.

General clinically indicated testing criteria (NCCN summary)

General clinically indicated testing scenarios (NCCN summary) where germline testing is indicated include ANY of the following:

Known familial pathogenic/likely pathogenic variant in a gene with established clinical significance.

Prior limited testing where broader panel testing is indicated to clarify risk or management.

A pathogenic or likely pathogenic variant identified in tumor sequencing that has implications for hereditary risk and management.

Germline testing will directly inform systemic therapy decisions, targeted therapy eligibility, or clinical trial enrollment.

Clinical scenarios meeting Li-Fraumeni, Cowden, Lynch syndrome diagnostic criteria, or other established hereditary cancer syndromes per guideline definitions.

Lynch syndrome (LS) testing criteria (CGA-IGC/NCCN/2022 resource)

Lynch syndrome (LS) testing criteria (CGA-IGC/NCCN/2022 resources):

Personal history criteria for LS-associated tumors as defined by guideline lists.

Family history criteria including first- and second-degree relatives meeting Lynch-associated tumor patterns.

Risk model thresholds: PREMM5, MMRpro, or MMRpredict scores with badges indicating >= 2.5% and >= 5% thresholds for different decision points.

Guideline-derived indications for germline multigene panel testing (ASCO, NCCN, others)

Guideline-derived indications for offering germline multigene panel testing and panel composition guidance:

Offer multigene panel testing when an individual's personal or family history meets established guideline criteria and when results would alter management.

Panels should include genes relevant to the tumor type or syndrome under evaluation; include high- and moderate-penetrance genes with established management recommendations and avoid large broad panels that include genes without clinical actionability unless specifically justified.

ASCO: When to offer germline testing based on tumor findings

ASCO: When to offer germline testing based on tumor findings:

Offer germline testing when tumor sequencing identifies pathogenic/likely pathogenic variants in genes with established germline implications.

Consider germline testing for additional genes listed by ASCO when tumour findings suggest possible hereditary predisposition; operational note: for probands age <30 evaluate genes associated with very early-onset syndromes (e.g., TP53) preferentially.

NCCN and specialty guidance indications (selected)

Selected NCCN and specialty guidance indications (summarized):

Pancreatic cancer: germline testing for all individuals with pancreatic cancer and selected unaffected relatives per family history.

Prostate cancer: germline testing for metastatic disease and other high-risk presentations; consider testing based on family history and ancestry.

Neuroendocrine/adrenal and paraganglioma/pheochromocytoma (PPGL): consider germline testing per specialty recommendations.

Revised Coverage Criteria Highlights (06/01/2025) and Unproven/Not Medically Necessary (added)

Policy updates and key coverage highlights effective 06/01/2025:

Revised Coverage Criteria Highlights (06/01/2025): Consolidation of personal- and family-history criteria, clarified score thresholds at 2.5% and 5% for prior-probability models, explicit inclusion of tumor-based triggers (tumor P/LP variants, MSI/dMMR) as indications for reflex germline testing, and specification that multi-gene panels consist of five or more genes for the purposes of this policy.

Unproven/Not Medically Necessary (added): Multi-gene hereditary cancer panels are considered unproven and not medically necessary for indications not explicitly listed as medically necessary; RNA panel testing and use of polygenic risk scores for hereditary cancer risk assessment are unproven and not medically necessary for all indications.

Billing Rule

Applicable procedure codes

List of applicable procedure codes associated with hereditary cancer genetic testing. Inclusion of a code here does not guarantee coverage; benefit determination is governed by the member's contract and applicable laws.

Codes shown in the policy's Applicable Codes section (e.g., CPT, HCPCS) are provided for reference only.
Listing a code does not imply that the coded service is a covered benefit or will be reimbursed.

Documentation Required

Genetic counseling and specialist referral

Refer individuals with positive results, complex findings, or who need specialized interpretation to a genetics professional (genetic counselor or medical geneticist). Document informed consent and counseling provided for testing and for result disclosure in the medical record.

Document the referral and any follow-up genetic counseling or specialist consultations in the contemporaneous medical record.

Billing Rule

Selection of gene panel

Select gene panels that include clinically relevant genes for the indication being tested. If ordering a broader panel that includes genes of uncertain or limited clinical utility, document the clinical rationale for including additional genes.

Document why a panel larger than the minimum clinically indicated set is necessary for the member’s management.
Note that panels are defined in this policy as tests that include five or more genes.

Prior Authorization

Offer germline testing when tumor testing reveals specified pathogenic variants

Offer germline testing when tumor testing identifies pathogenic variants or tumor features that suggest possible hereditary cancer (e.g., MSI-high, loss of MMR protein expression). Document the tumor findings used to justify germline testing when ordering.

Attach tumor molecular report, immunohistochemistry results, or pathology report showing MSI/MMR status when submitting germline testing requests.

Documentation Required

Be cautious with PRS

If considering polygenic risk scores (PRS), exercise caution. Provide counseling about limitations and uncertainties, and document counseling and the rationale if PRS results will be used in clinical decision-making. ACMG cautions against routine clinical use of PRS for most hereditary cancer risk assessments.

Document informed discussion with the patient regarding the limitations, potential benefits, and uncertainties of PRS.