CurrentProvidence Health PlanPolicy 115

Genetic Testing for Inherited Susceptibility to Colorectal, Endometrial and Gastric Cancer

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Policy governs medical necessity criteria, documentation, and coverage stance for germline genetic testing for hereditary colorectal, endometrial and gastric cancer syndromes for Providence Health Plan commercial members and affiliated product lines.

Policy Summary

PayerProvidence Health Plan

PolicyGenetic Testing for Inherited Susceptibility to Colorectal, Endometrial and Gastric Cancer

Policy CodePolicy 115

Change TypeRoutine review — no material changes

Effective DateJul 1, 2026

Last ReviewJul 1, 2026

Next Review DateJun 1, 2027

Key ActionInclude documentation of pre-test genetic counseling per policy MP316 and submit required clinical notes and test details with any authorization request.

SourceLink

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentProvidence Health PlanPolicy 115

Genetic Testing for Inherited Susceptibility to Colorectal, Endometrial and Gastric Cancer

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Sign up for Providence Health Plan Policy 115 alerts

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Policy Summary

PayerProvidence Health Plan

PolicyGenetic Testing for Inherited Susceptibility to Colorectal, Endometrial and Gastric Cancer

Policy CodePolicy 115

Change TypeRoutine review — no material changes

Effective DateJul 1, 2026

Last ReviewJul 1, 2026

Next Review DateJun 1, 2027

Key ActionInclude documentation of pre-test genetic counseling per policy MP316 and submit required clinical notes and test details with any authorization request.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

27genes explicitly listed as covered when criteria met

24genes listed as medically necessary when criteria met

>=10adenoma threshold

<50 yearsage threshold

Commercial onlyplan scope

NCCN v.1.2025guideline version

Coverage and Medical Necessity Criteria

inv-01: Medically Necessary Criteria (I)

Covered when ALL of the following are met: genetic counseling requirements (per MP316) AND one of criteria A–F below.

Main

A: Known familial pathogenic variant: Documentation indicates a first-degree relative has a known pathogenic mutation in one of the listed genes and testing is targeted to the identified mutation.
[[chunk 7]]
B: Personal history qualifying features: Patient has a personal history of any one of: 1) ≥10 adenomas; 2) ≥2 hamartomatous polyps; 3) ≥5 serrated polyps/lesions proximal to the rectum; 4) colorectal, endometrial, or gastric cancer diagnosed <50 years; 5) colorectal, endometrial, or gastric cancer plus another Lynch syndrome-related cancer (synchronous or metachronous); 6) colorectal, endometrial, or gastric cancer plus one or more first- or second-degree relatives with an LS-related cancer diagnosed <50 years; 7) colorectal, endometrial, or gastric cancer plus two or more first- or second-degree relatives with LS-related cancers, regardless of age; 8) colorectal, endometrial, or gastric cancer at any age with tumor showing mismatch repair deficiency (MSI or loss of MMR protein expression).>=10 adenomas for adenoma criterion
[[chunk 7]]
C: Family history qualifying features: Patient has a family history meeting any one of: 1) one or more relatives with either (a) ≥10 adenomas, (b) ≥2 hamartomatous polyps, or (c) ≥5 serrated polyps/lesions proximal to the rectum; 2) one or more first-degree relatives with colorectal, endometrial, or gastric cancer diagnosed <50 years; 3) one or more first-degree relatives with colorectal, endometrial, or gastric cancer plus another LS-related cancer; 4) two or more first- or second-degree relatives with LS-related cancers including at least one diagnosed <50 years; 5) three or more first- or second-degree relatives with LS-related cancers regardless of age.
[[chunk 8]]
D: Risk prediction model thresholds: Either: 1) an individual with an LS-related cancer or an unaffected individual with ≥5% risk for an MMR gene mutation based on MMRpro, PREMM5, or MMRpredict; or 2) an unaffected individual without personal history of colorectal or endometrial cancer with ≥2.5% risk for an MMR gene mutation based on these models.>=5% or >=2.5% depending on scenario
[[chunk 8],[12]]
E: Age-based consideration: Individuals with colorectal or endometrial cancer aged ≥50 years who do not meet other testing criteria AND have no known mismatch repair deficiency in tumor testing may be considered for testing.age >=50
[[chunk 8]]
F: Tumor testing finding: A pathogenic or likely pathogenic variant identified on tumor genomic testing that has clinical implications may indicate germline testing.
[[chunk 8]]

inv-02: Medically Necessary Criteria (II)

II: BRAF V600E testing or MLH1 promoter methylation testing is medically necessary to rule out Lynch syndrome in patients with loss of MLH1 protein expression on IHC tumor testing or an MSI-H tumor result.

[[chunk 8]]

inv-03: Not Medically Necessary

III: Germline testing for the listed genes is not medically necessary when criteria I or II are not met; examples include testing for general population cancer risk assessment and when the family variant is a variant of unknown significance (VUS).

[[chunk 9]]

IV: Repeat testing of the same germline genetic content for the same genetic information is considered not medically necessary.

[[chunk 9]]

V: Genetic panel testing that includes genes beyond the listed set is considered not medically necessary unless it meets the Next Generation Sequencing for Cancer (MP352) criteria; examples of not medically necessary panels are listed in the policy.

[[chunk 9]]

inv-04: Medically necessary gene testing

Covered when policy criteria and NCCN-based clinical criteria are met

Medically necessary gene testing: Germline testing for APC, AXIN2, BMPR1A, BRCA1, BRCA2, CDH1, EPCAM, GREM1, MLH1, MLH3, MSH2, MSH3, MSH6, MUTYH, NTHL1, POLD1, POLE, PMS2, PTEN, RPS20, SMAD4, STK11 (LKB1), and TP53 is considered medically necessary when the policy clinical criteria (aligned with NCCN) are met.

Supported by NCCN guidance

inv-05: Tumor testing (BRAF / MLH1 methylation)

Tumor-based testing to guide germline testing

Tumor tests: BRAF V600E mutation testing or MLH1 promoter methylation testing is medically necessary when used to distinguish sporadic colorectal or endometrial cancers from Lynch syndrome (for example, when tumors show MLH1 loss or are MSI-H).

NCCN-recommended in MLH1-deficient or MSI-H tumors

inv-06: NCCN-based indications

NCCN scenarios where genetic testing is recommended

NCCN indicated scenarios: Individuals with any blood relative with a pathogenic/likely pathogenic variant; individuals meeting Lynch syndrome testing criteria (personal/family history or dMMR tumor); those meeting adenomatous polyposis or specific syndrome criteria (JPS, PJS, HDGC, LFS, Cowden/PHTS); individuals with personal or family history of colorectal, endometrial, or gastric cancer; individuals meeting specified polyp burden thresholds; and other scenarios where multigene testing is supported by NCCN (eg, multiple genes could explain the syndrome or prior limited testing was negative).

List derived from NCCN v.1.2025

This policy addresses testing for well-defined inherited cancer syndromes only, including Lynch syndrome and recognized polyposis syndromes (eg, adenomatous polyposis, MUTYH-associated polyposis, Peutz‑Jeghers, juvenile polyposis, and serrated polyposis). Tests for additional, lower‑penetrance syndromes or genes outside these listed syndromes are not addressed by this policy and may be subject to review under the plan's broader Genetic and Molecular Testing policies.

Multigene panel testing that includes genes beyond the NCCN‑recommended list identified in this policy is considered not medically necessary unless the panel request meets criteria per the plan's Next Generation Sequencing for Cancer policy (MP352). Examples of noncovered panels are listed in the policy and panels that add genes outside the defined set are not supported by current guidelines.

Germline testing is not medically necessary for general population cancer risk assessment, when the reported familial variant is a variant of uncertain significance (VUS), or when tumor testing demonstrates a BRAF V600E mutation or MLH1 promoter hypermethylation. Requests must include required documentation (test name/genes, laboratory, clinical notes and genetic counseling documentation) so reviewers can determine clinical utility; absence of this documentation may affect coverage determination.

Genetic testing for Lynch syndrome and polyposis syndromes is not medically necessary when individuals do not meet the policy's specified clinical or family history criteria. The policy notes that testing low‑risk individuals or broad panels that include genes not on the NCCN‑recommended list is not supported and may lead to unnecessary interventions and uncertain management.

Specific Covered Indications

Eligibility and Testing Pathways

Evaluate eligibility using both maternal and paternal histories separately. Family‑history‑based indications include relatives with >=10 adenomas, relatives with >=2 hamartomatous polyps, or >=5 serrated polyps proximal to the rectum, as well as specified patterns and ages of Lynch‑related cancers in first‑ and second‑degree relatives. When possible, affected family members should be tested first and pre‑test counseling should document reasons if that is not feasible.

See the coverage criteria and NCCN‑aligned scenarios in the policy for full eligibility specifics and examples that operationalize the A–F criteria; these include detailed personal and family history thresholds, risk‑model cutoffs, and tumor‑based findings that trigger testing.

NCCN‑based guidance supports ordering multigene testing when prior limited testing (for example, single‑gene sequencing or absence of deletion/duplication analysis) was negative or incomplete and clinical suspicion persists. The policy also emphasizes testing affected family members first when possible and requires documentation of genetic counseling per MP316 to support multigene testing decisions.

Provider Requirements and Prior Authorization

Prior Authorization

Prior authorization/supporting documentation required

Requests for genetic testing must include the required documentation listed in the Documentation Requirements so the plan can determine clinical utility; failure to submit complete documentation may affect the outcome of the review and may lead to denial.

Provide specific gene, trade or proprietary test name (or list every gene/component for custom tests)
Name of laboratory performing the test
Clinical notes including documentation of genetic counseling per MP316 describing how results will impact clinical decision making
If applicable, pre-test counseling note documenting why an affected family member cannot be tested first
Reason/indication, signs/symptoms, prior related test results, family history, impact on clinical decision making
All relevant CPT/HCPCS codes billed

Prior Authorization

Prior authorization recommended for unlisted/complex molecular tests

Billing Codes and Coding Guidance

Billing/CPT codes referencedCPT

81201	APC full gene sequence (example mapping in document)
81202	APC gene analysis, known familial variants
81203	APC gene analysis; duplication/deletion variants
81210	BRAF V600E variant analysis
81288	MLH1 promoter methylation analysis (listed)
81292	MLH1 full sequence analysis
81293	MLH1 known familial variants
81294	MLH1 duplication/deletion
81295	MSH2 full sequence analysis
81296	MSH2 known familial variants

1–10 of 19

1/2

Adenoma count threshold — Key numeric threshold used by policy

Adenoma count threshold>= 10 adenomas

Related family-history thresholdOne or more relatives with >=10 adenomas qualifies under family-history criteria

Context of useUsed as a personal-history criterion (patient) or family-history criterion (relative) to meet medically necessary testing indications

Not Covered / Exclusions

Specific multi‑gene panels that include genes beyond the listed set are identified as examples of tests that are not covered. These example panels include proprietary commercial panels called out in the policy as not medically necessary when they include genes outside the policy's defined list.

Multigene panels that include genes not on the NCCN‑recommended list and testing performed in individuals who do not meet the policy’s clinical or family history thresholds are considered not medically necessary. The policy states that such expanded panels have not been shown to improve health outcomes and are not supported by current clinical guidelines.

Background and Scope

This policy focuses on well‑defined inherited cancer syndromes including Lynch syndrome, adenomatous and other polyposis syndromes, Peutz‑Jeghers syndrome, juvenile polyposis, and serrated polyposis. The document clarifies that immunohistochemistry (IHC) and microsatellite instability (MSI) tumor testing are not addressed by this germline policy and may be considered standard of care separately.

Definitions and Terms

Close Blood Relatives — Definition per NCCN

DefinitionClose blood relatives are first-, second-, and third-degree relatives on the same side of the family (first-degree: parents, siblings, children; second-degree: grandparents, aunts, uncles, nieces and nephews, grandchildren, half-siblings; third-degree: great-grandparents, great-aunts, great-uncles, great-grandchildren, first cousins)

Same-side requirementRelatives must be on the same side of the family to be considered 'close' per NCCN

Examples includedHalf-siblings counted as second-degree; first cousins counted as third-degree

Lynch Syndrome-Related Cancers — List of cancers considered Lynch-related

Included cancersColorectal, endometrial, gastric, ovarian, pancreatic, ureter/renal pelvis

Additional included malignancies

Policy Summary

PayerProvidence Health Plan

PolicyGenetic Testing for Inherited Susceptibility to Colorectal, Endometrial and Gastric Cancer

Policy CodePolicy 115

Change TypeRoutine review — no material changes

Effective DateJul 1, 2026

Last ReviewJul 1, 2026

Next Review DateJun 1, 2027

Key ActionInclude documentation of pre-test genetic counseling per policy MP316 and submit required clinical notes and test details with any authorization request.

SourceLink

On This Page

Prior authorization is recommended for complex, multigene, or unlisted molecular test submissions to avoid post-service denial; unlisted codes for potentially covered services should have prior authorization.

All unlisted codes are reviewed at the claim level and may be denied if submitted for non-covered services
To avoid post-service denial, prior authorization is recommended when an unlisted code is submitted for a potentially covered service

Step Therapy

Test affected family members first when possible

When feasible, order testing of an affected family member with cancer before testing unaffected relatives; if an affected member cannot be tested first, pre-test counseling notes must document the reason.

Testing an unaffected member has significant limitations for interpretation
Document in pre-test counseling why affected family member could not be tested prior to testing an unaffected member

Step Therapy

Perform sequential tumor testing to guide germline testing

When tumor results show MLH1 loss or MSI‑H, perform sequential tumor testing (e.g., BRAF V600E mutation testing or MLH1 promoter methylation) to help distinguish sporadic tumors from Lynch syndrome and to guide whether germline testing is indicated.

BRAF V600E or MLH1 promoter methylation testing is considered medically necessary to rule out Lynch syndrome in MLH1‑deficient or MSI‑H tumors
Use these tumor tests to guide appropriate use of germline testing

Documentation Required

Required documentation at time of request

At the time of request include the specific test name or genes, the laboratory name, and clinical notes that include documentation of genetic counseling per MP316; incomplete documentation may affect review outcome.

List specific gene(s), trade/proprietary test name, or every gene/component for custom tests
Provide laboratory name and prior related test/laboratory results
Include clinical notes documenting genetic counseling and how results will impact clinical decision making

Documentation Required

Genetic counseling and clinical documentation required

Testing must be performed in the context of pre‑ and post‑test genetic counseling by certified genetic counselors or clinicians with expertise in hereditary syndromes; counseling notes must document how test results will impact clinical decision making.

NCCN and policy require counseling by certified genetic counselors or clinicians with extensive training in cancer genetics
Counseling documentation should state how results will affect management and decision making

Denial Risk

Denial risk when policy criteria are not met

Tests that do not meet the policy clinical criteria (including panels that include genes beyond the listed set) are considered not medically necessary and may be denied.

Genetic testing is not medically necessary when criteria I or II are not met
Panels that include genes beyond the listed set are considered not medically necessary

Denial Risk

Denial risk for non‑qualifying clinical/family histories or unlisted codes

Tests submitted for individuals who do not meet the policy's specific clinical or family history criteria, or unlisted codes submitted for non‑covered services, may be denied as not covered.

Genetic testing for Lynch syndrome and polyposis syndromes is not considered medically necessary when individuals do not meet specific clinical or family history criteria
Unlisted codes submitted for non‑covered services will be denied as not covered

Documentation Required

Document pre‑test genetic counseling per MP316

Pre‑test genetic counseling documentation per MP316 is required and must document how results will impact clinical decision making; counseling notes should also record reasons if an affected family member cannot be tested first.

Documentation must show how test results will impact management decisions
If affected family member not tested first, pre‑test counseling must explain why

Note

Ordering clinician must document counseling and expertise when applicable

Policy requires documentation of genetic counseling per MP316 but does not restrict which clinician types can order testing; ordering clinicians must supply required documentation and, when not a genetics specialist, should document relevant expertise.

Ordering clinician must provide the documentation required at time of request
If the ordering clinician is not a genetics specialist, document the clinician’s relevant expertise in hereditary syndromes

Note

Conduct testing under guidance of genetics‑trained clinicians

Testing is recommended to be conducted under the guidance of genetic counselors or clinicians with expertise in hereditary syndromes; non‑specialist ordering clinicians should follow the counseling and documentation requirements.

NCCN recommends multi‑gene testing be done in context of pre‑ and post‑test counseling by certified genetic counselors or clinicians with extensive training
Policy recommends testing under guidance of clinicians with expertise in hereditary syndromes

Brain (usually glioblastoma), small intestine cancers

Associated skin tumorsSebaceous adenomas and carcinomas, and keratoacanthomas (as seen in Muir-Torre syndrome)

Clinical utility — Definition of clinical utility used in policy

Core definitionEvidence that test results can be used to guide treatment, management, or preventive decisions and that those decisions lead to improved primary health outcomes

Purpose in policyClinical utility is a key component in determining a test's usefulness for coverage decisions

ApplicationUsed to evaluate whether genetic testing results will change clinical management and improve outcomes