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CurrentProvidence Health PlanPolicy 443

Genetic and Molecular Testing for Inherited Cancer Risk

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Medicare medical policy governing coverage criteria for genetic and molecular testing for inherited cancer risk for Providence Health Plan Medicare products; affects ordering providers, laboratories, and Medicare Advantage members.

Policy Summary

PayerProvidence Health Plan

PolicyGenetic and Molecular Testing for Inherited Cancer Risk

Policy CodePolicy 443

Change TypeNo material change

Effective DateJul 1, 2026

Next Review DateAug 1, 2026

Key ActionOrder hereditary germline panel tests only when a treating qualified provider documents a personal cancer history and clinical indications meeting NCCN/MolDX criteria; use unlisted codes (81479/81599) or proper PLA/U-codes when no specific panel code exists and obtain prior authorization for unlisted codes to avoid post-service denial.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Medicare OnlyProduct

Not coveredRepeat germline testing

Generally N/MICustom panels

NCD 90.2NCD referenced

Multiple citedMAC/LCD

Coverage Criteria — Medical Necessity Rules

General Coverage Criteria (Medicare multigene panel testing for hereditary cancer)

Genetic multigene panel testing may be considered medically necessary when ALL of the following are met:

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Single gene testing coverage criteria (Medicare rules)

Genetic single gene testing for hereditary cancer syndromes may be considered medically necessary when ONE of the following is met

Root

Policy Summary

PayerProvidence Health Plan

PolicyGenetic and Molecular Testing for Inherited Cancer Risk

Policy CodePolicy 443

Change TypeNo material change

Effective DateJul 1, 2026

Next Review DateAug 1, 2026

SourceLink

On This Page

Known familial variant (KFV) analysis

KFV testing may be considered medically necessary when BOTH of the following are met

Root

A: Member meets the policy's clinical requirements for KFV testing (documentation shows the familial pathogenic/likely pathogenic variant and clinical circumstances support targeted testing).
See policy for the full enumerated clinical requirements for KFV testing.
B: The targeted KFV test meets analytical and clinical validity and demonstrates clinical utility as evidenced by MolDX TA or FDA approval/clearance within labeling (or other Medicare-acceptable evidence).MolDX TA or FDA within labeling
Targeted testing is limited to the known familial pathogenic variant when present.

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Targeted Variant Testing

Situations where targeted testing is appropriate

Root

A: When a pathogenic or likely pathogenic variant is identified on tumor genomic testing and the clinical implication is limited to that variant, germline testing should be limited to the known tumor-identified pathogenic variant.
See policy: targeted testing limited to known tumor variant (refer to Criterion III).
B: When a first-degree relative has a known pathogenic or likely pathogenic variant, testing should be limited to the known familial pathogenic variant (KFV) rather than broad panel testing.
See Criterion III for KFV specifics.

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Coding — CPT/HCPCS, PLA/U-codes and LCAs

MolDX-listed tests with CPT/HCPCS identifiersCPTCovered

0129U	BRCAplus (Ambry Genetics)
0475U	ProstateNow™ Prostate Germline Panel (GoPath Diagnostics)

Named CPT code for proprietary testCPT

0475U

ProstateNow™ Prostate Germline Panel (GoPath Diagnostics, Inc.)

Listed proprietary/HCPCS/CPT II codes (not covered examples)CPTNot Covered

0138U	+RNAinsight™ for BRCA1/2 (Ambry Genetics)
0134U	RNAinsight™ for CancerNext® (Ambry Genetics)
0133U	RNAinsight™ for ProstateNext® (Ambry Genetics)
0651U	OncoDx™ (Hereditary Germline Cancer Genetics Panel) (Personalized Medicine Care Diagnostics)
0474U	GeneticsNow™ Comprehensive Germline Panel
0136U	+RNAinsight™ for ATM (Ambry Genetics)
0137U	+RNAinsight™ for PALB2 (Ambry Genetics)

Required billing codesmixed

CPT/HCPCS

CPT and/or HCPCS code(s) billed (specific codes must be provided on documentation)

Referenced coverage policy identifiersmixed

NCD 90.2

National Coverage Determination for Next Generation Sequencing (applies to germline breast/ovarian tests meeting criteria)

General panel coding guidance (CPT ranges and panel codes)CPT | HCPCS | mixed

81410-81471	CPT range referenced for molecular pathology/genetic testing panels
815XX	Multianalyte assays with algorithmic analyses (MAAA) codes referenced
81479	Unlisted molecular pathology procedure – used when no specific panel code exists
81599	Unlisted multianalyte/proprietary assay – used when no specific code exists
87999	Not otherwise classified lab code – referenced as possible NOC in context

Proprietary/PLA (U) codes and examplesCPT | HCPCS | mixed

0102U	Example proprietary U-code — ColoNext® hereditary colon cancer panel (Ambry Genetics) (example)
0103U	Example proprietary U-code — BreastNext® hereditary breast cancer panel (Ambry Genetics) (example)
0129U	Proprietary U-code example for hereditary breast cancer-related disorders (BRCAplus, Ambry Genetics)
0130U	RNAinsight™ (ColoNext®) targeted mRNA sequence analysis (list separately)
0132U	RNAinsight™ (BreastNext®) targeted mRNA sequence analysis (list separately)
0133U	RNAinsight™ for ProstateNext® (example)
0134U	RNAinsight™ pan-cancer panel (example)
0136U	RNAinsight™ gynecological cancer panel (example)
0137U	PALB2 mRNA sequence analysis (example)
0138U	BRCA1/2 mRNA sequence analysis (example)

1–10 of 19

1/2

Local Coverage Articles (LCAs) referencesmixed

A58681	Noridian J-F LCA: Lab-Developed Tests for Inherited Cancer Syndromes
A58679	Noridian J-E LCA: Lab-Developed Tests for Inherited Cancer Syndromes
A58652	Palmetto LCA: Lab-Developed Tests for Inherited Cancer Syndromes
A57450	First Coast LCA: Genetic Testing for Lynch Syndrome (BRCA-specific and Lynch-specific LCAs are referenced)

Referenced U-codes (examples)HCPCS

0235U	Proprietary / panel test code referenced in sequences with 0238U
0238U	Proprietary / panel test code (frequently paired with other U-codes in examples)

Referenced U-codes (additional)HCPCS

0474U	Proprietary / panel test code referenced for various hereditary panels
0475U	Proprietary / panel test code referenced for various hereditary panels

Referenced U-codes (larger panels)HCPCS

0651U

Proprietary / panel test code referenced for larger hereditary panels or reports

Referenced CPT codesCPT

81162	Molecular pathology procedure code used in examples associated with panel reporting/interpretation
81163	Additional molecular pathology procedure code used in examples (e.g., BRCA analysis)

Appropriate CPT/HCPCS and Molecular Pathology Codes (~50 codes)mixed

0475U	Oncology (hereditary cancer) genomic sequence analysis panel (commercial LDT examples referenced)
0651U	Oncology (hereditary cancer), genomic DNA, hereditary cancer predisposition gene panel (commercial LDT examples referenced)
81162	BRCA1, BRCA2 gene analysis; full sequence analysis and full duplication/deletion analysis
81163	BRCA1, BRCA2 gene analysis; full sequence analysis
81164	BRCA1 gene analysis; full duplication/deletion
81165	BRCA2 gene analysis; full duplication/deletion
81201	APC gene analysis; full gene sequence
81202	APC gene analysis; known familial variants
81203	APC gene analysis; duplication/deletion variants
81210	BRAF gene analysis, V600E variant

1–10 of 50

1/5

Referenced LCDs for molecular diagnostic testingmixed

L35025	Palmetto GBA LCD for Molecular Diagnostic Tests (MDT)
L35160	Noridian J-E LCD for Molecular Diagnostic Tests (MDT)
L36021	CGS LCD for Molecular Diagnostic Tests (MDT)
L36256	Noridian J-F LCD for Molecular Diagnostic Tests (MDT)
L36807	WPS LCD for Molecular Diagnostic Tests (MDT)

Referenced LCAs for MolDX panel definitionsmixed

A59685	Noridian J-E LCA for MolDX: Defining panel services in MolDX
A59687	Noridian J-F LCA for MolDX: Defining panel services in MolDX
A59678	Palmetto GBA LCA for MolDX: Defining Panel Services in MolDX
A59700	WPS LCA for MolDX: Defining Panel Services in MolDX
A59698	CGS LCA for MolDX: Defining Panel Services in MolDX

Panel gene relevance

Panel gene relevanceAll genes included in a panel must be relevant to the individual’s personal and family history; panels should only include the number of genes reasonable and necessary to establish diagnosis.

Targeted panel selectionLabs performing MMR germline panels must select targeted genes based on patient data, screening test (MSI/IHC) results, or documented exceptions.

Custom panelsCustom panels with genes not clearly tied to the clinical indication may be considered not reasonable and necessary.

PREMM5 risk threshold

PREMM5 threshold for testing≥ 5% risk of having an MMR gene pathogenic variant is the criterion for testing.

PREMM5 consideration for panelsIndividuals with a personal history of colorectal or endometrial cancer and PREMM5 ≥2.5% should be considered for multigene panel testing.

Predictive model examplesPREMM5 is listed alongside MMRpro and MMRpredict as accepted predictive models for estimating MMR PV risk.

PREMM5 threshold nuance (personal history of CRC/EC)

Personal history nuance — lower PREMM5 thresholdFor individuals with a personal history of colorectal (CRC) or endometrial cancer (EC), a PREMM5 score ≥2.5% should prompt consideration of multigene panel testing.

Standard PREMM5 testing cutpointA PREMM5 score ≥5% remains the formal criterion to indicate testing by predictive-model thresholds.

Action based on tumor findingsWhen tumor testing identifies a pathogenic variant, germline testing should be limited to the known pathogenic variant (see Criterion III).

Predictive model MMR PV risk threshold

Predictive model MMR PV risk threshold≥ 5% risk of having an MMR gene pathogenic variant by models such as MMRpro, PREMM5, or MMRpredict is a criterion for testing.

Models referencedMMRpro, PREMM5, and MMRpredict are explicitly cited as accepted predictive models for estimating MMR PV risk.

Tumor-directed considerationsTumor MSI-H or loss of MMR protein expression remain independent indicators and are used alongside predictive model thresholds.

Panel gene count

Example largest panel sizeAn example hereditary pan-cancer panel described includes 88 genes (with 20 duplications/deletions reported).

Panels with CNV analysisExample panels of this size include copy-number/duplication testing (e.g., 20 duplications/deletions noted for the 88-gene panel).

Report formatsLarge panels are reported per gene as positive or negative for germline variants using NGS and complementary methods (Sanger, CNV methods).

Panel size thresholds mapped to molecular pathology CPT levels

Molecular pathology CPT level descriptorsCPT molecular pathology levels describe exon/amplicon counts (examples: Level 7 = analysis of 11–25 exons; Level 8 = 26–50 exons; Level 9 = >50 exons).

Panel-to-code mappingGenomic sequence analysis panel codes (e.g., 81432, 81435, 81437) apply for panels of ≥5 genes with sequence and copy number interrogation; unlisted codes (81479, 81599) used when no specific code exists.

Use unlisted codes when neededWhen a single panel-specific CPT/HCPCS code does not exist, an unlisted molecular pathology or multianalyte code should be used (and prior authorization is recommended).

Manchester Scoring System threshold

Manchester Scoring System thresholdManchester Scoring System: score of 15 or higher indicates significant risk for hereditary breast cancer referral/testing.

Context of useListed as one of the risk stratification tools in Appendix II used to identify moderate or high risk for referral/testing.

Relation to NCCN guidanceRisk stratification tools and thresholds are applied alongside clinical guidelines to determine testing eligibility.

Ontario Family History Assessment Tool threshold

Ontario Family History Assessment Tool thresholdOntario Family History Assessment Tool: score of 10 or higher indicates moderate or high risk for hereditary breast cancer referral/testing.

Appendix referenceThreshold is listed in Appendix II as an example tool and cutpoint for referral/testing decisions.

Use with clinical judgmentTool scores should be used in conjunction with clinical indications and family history to determine testing appropriateness.

Tyrer-Cuzick threshold

Tyrer-Cuzick thresholdTyrer-Cuzick: score of 10% or higher used as a threshold indicating moderate or high risk for hereditary breast cancer referral/testing.

Appendix guidanceListed in Appendix II among example risk stratification tools and their score thresholds for referral/testing.

Clinical integrationTyrer-Cuzick score should inform, but not solely determine, the decision to proceed with genetic testing; corroborating clinical indications are required for Medicare coverage.

MolDX-approved tests and CPT identifiers

MolDX-approved panel examples and CPT identifiersCertain named panels (examples in policy) have associated CPT/HCPCS identifiers and may meet MolDX technical assessment (e.g., listed proprietary panels referenced in policy tables).

Ordering must align with LCD/MolDXOrdering and coverage must align with Medicare criteria and applicable LCD/MolDX rules; MolDX technical assessment underpins Criterion I.C.

Use listed codes when applicableWhen a proprietary/PLA (U-) code exists for a panel that meets MolDX review, providers should report the exact code corresponding to the laboratory test performed.

Provider Actions — Ordering, Documentation, and Billing

Note

Use MolDX/LCD‑approved panels and report the exact test code

Order MolDX-listed panels only when the test and ordering meet Medicare/MolDX criteria and applicable LCD requirements; report the exact CPT/HCPCS/PLA (U-) code that corresponds to the MolDX-approved test submitted by the performing laboratory.

MolDX-approved tests listed as examples include vendor panels (e.g., CancerNext series, ColoNext, GeneticsNow/OncoDx/ProstateNow) and associated U-codes (e.g., 0102U, 0238U, 0474U, 0475U).
Medicare/MolDX/LCD rules (NCD 90.2; MolDX Program Manual; referenced LCDs) apply to coverage determinations and code reporting.

Prior Authorization

Expect prior review for custom panels

Custom or 'customized' panels are generally considered not medically necessary and require special justification or prior review for rare/unique clinical situations.

Custom panels lack a defined intended-use population and typically will not pass MolDX technical assessment; only request when no commercial panel exists and clinical criteria are met.
Prepare to submit clinical justification and consider pre-service review for these panels.

Documentation Required

Order by treating provider and meet AV/CV/CU requirements

Ensure the test is ordered by the treating qualified healthcare provider and that documentation demonstrates analytic validity, clinical validity, and clinical utility per Medicare/MolDX standards.

Order must be placed by the treating physician/practitioner who will use results to manage the member's specific medical problem.
Tests must meet AV/ CV and demonstrate clinical utility (MolDX TA or FDA within labeling where applicable).

Billing Rule

Bill panels as a single service; use unlisted code if needed

When no single CPT/HCPCS panel code exists for the entire panel, bill the service as a single unlisted molecular pathology or multianalyte unlisted code (e.g., 81479 or 81599) rather than billing individual component tests.

Do not unbundle panel components or 'stack' multiple Tier I molecular pathology codes to represent a single panel.
Select the single most appropriate code for the panel; use NOC codes (81479, 81599, or 87999) if no specific panel code exists.

Billing Rule

Report the exact HCPCS/CPT/PLA code(s) used by the performing lab

Report the exact CPT/HCPCS (and PLA/U-code where applicable) that matches the laboratory's performed test and include component codes for single‑gene or known‑variant testing as specified.

Examples of panel and component codes are provided in the policy (e.g., 0238U, 0474U, 0475U, 0651U, 81162, 81163, 81432, 81435, 81479).
Document and submit the exact code(s) that correspond to the panel or single‑gene assay performed by the lab.

Prior Authorization

Recommend prior authorization for unlisted molecular/assay codes

Obtain prior authorization when submitting unlisted molecular/assay codes for services that may be covered to reduce the risk of post‑service denial.

Unlisted codes (e.g., 81479, 81599, 84999) are reviewed at claim level for medical necessity, coding, and pricing; prior authorization is recommended for potentially covered unlisted submissions.
Follow payer/provider pre-service review processes when available.

Note

Adhere to LCD/MolDX coverage and technical assessment requirements

Follow applicable LCD, LCA, and MolDX coverage rules and technical assessment outcomes (Palmetto GBA, Noridian, CGS, WPS, etc.) when ordering, documenting, and submitting molecular diagnostic claims.

Medicare Advantage plans must follow Medicare rules and MAC/LCD determinations; use MolDX DEX registry to confirm a test's technical assessment status.
Referenced LCDs/LCAs (e.g., L35025, L35160, L36021, L36256, L36807 and MolDX LCAs) define coverage and coding expectations.

Step Therapy

Perform recommended tumor screening (IHC/MSI) before germline panel testing when indicated

Complete recommended first‑line tumor screening (e.g., IHC and/or MSI testing for mismatch repair deficiency) prior to or to inform germline panel testing when indicated by the clinical context.

IHC/MSI tumor screening and reflex somatic tests (e.g., BRAF V600E or MLH1 promoter methylation) may be required to determine need for targeted germline testing.
Lack of appropriate prior screening can render germline panel testing not reasonable and necessary under Medicare rules.

Note

Apply LCD/MolDX guidance to choose single‑gene vs panel testing

Follow MolDX/LCD guidance that limits when single‑gene testing versus broader panels are appropriate; Medicare Advantage plans must apply local coverage criteria before broader testing.

Criterion II.C requires that a single gene be the only reasonable/necessary gene for that cancer type before single‑gene testing is appropriate.
When NCD/LCDs provide state‑specific rules (e.g., BRCA or Lynch LCDs), apply those LCD criteria.

Documentation Required

Order by treating qualified provider and document intended use of results

Ordering provider must be the treating qualified healthcare provider and medical records must justify ordering and demonstrate how results will be used promptly to manage the member's condition.

Documentation should show the ordering clinician is treating the patient for the specific medical problem and that results will affect management.
If the test was not ordered by the treating physician, it may not meet Criterion I.A and can be non‑covered.

Documentation Required

Provide clinical documentation showing member meets coverage criteria

Clinical documentation must demonstrate that the member meets coverage criteria and include treating physician information and justification that repeat or overlapping panel testing will provide new clinically meaningful information.

Documentation must show cancer diagnosis/personal history and relevant clinical indications or risk factors per policy criteria (e.g., NCCN thresholds).
For repeat or overlapping panels, document why additional testing is necessary and what new information is expected.

Documentation Required

Submit complete documentation for medical‑necessity review

For medical necessity review, submit CPT/HCPCS codes billed; panel/test name; gene(s) or components for single‑gene tests; name/location of performing lab; and clinical notes documenting consent, condition, prior tests, family history, and how results will impact care.

Required items listed include CPT/HCPCS billed, test/panel name, gene list or components, lab name/location, and clinical notes supporting indication and expected clinical utility.
Omission of these items may delay review or affect decision outcome.

Documentation Required

Document clinical indications, risk scores, and tumor test results

Document clinical indication details (personal/family history, predictive model scores, tumor testing results) consistent with Lynch syndrome or other hereditary syndromes when applicable.

Include predictive model scores (e.g., PREMM5 ≥2.5% considered for panel; ≥5% as testing criterion) or tumor MSI/IHC findings when relevant.
State how the clinical and family history satisfy policy criteria for the requested testing.

Billing Rule

Ensure billing reflects the specimen type reported by the lab

Match billing to the specimen type reported by the laboratory (commonly blood or saliva; some panels permit nail clipping) and include specimen type in documentation.

Specimen types referenced include blood, saliva, and in specific tests nail clipping; billing and documentation should reflect the specimen used.
Include specimen type in the submission to assist claim/jurisdiction handling.

Billing Rule

Unlisted codes are subject to claim‑level review; prior authorization recommended

Expect unlisted codes to be reviewed for medical necessity, correct coding, and pricing at claim level; prior authorization is recommended for potentially covered unlisted submissions.

If an unlisted code is submitted for a non‑covered service addressed in this policy it will be denied as not covered.
Provider contracts, member benefits, eligibility, and utilization audits can influence claim outcomes.

Denial Risk

Do not order tests lacking analytic/clinical validity or demonstrated clinical utility

Medicare will not cover tests that lack analytical/clinical validity or clinical utility; order only tests with established validity/utility as defined by MolDX technical assessment or FDA approval when applicable.

Panels including genes or biomarkers without demonstrated validity/utility are listed as non‑covered examples in the policy.
Refer to MolDX DEX registry and LCDs to confirm a test's coverage/assessment status before ordering.

Denial Risk

Avoid non‑treating orders and unsupported indications to reduce denial risk

Tests ordered by non‑treating physicians or when the member does not meet clinical coverage criteria (no personal cancer history, no qualifying indication/risk, prior identical germline testing) may be denied.

Medicare does not allow testing based on family history alone; testing without a personal history of relevant signs/symptoms is considered screening and is non‑covered.
Ensure the ordering clinician is treating the member and that policy criteria I.A and I.B are satisfied.

Denial Risk

Do not submit repeat or duplicate germline testing

Repeat germline testing or duplicative testing of the same germline content in the same individual is considered not medically necessary and will be denied.

The germline sequence does not change over time; repeat testing for identical content is not covered (exceptions exist for somatic testing).
Document any justification if additional testing claims to provide new clinically meaningful information.

Documentation Required

Provide complete documentation or risk delayed review/denial

Failure to include required documentation elements (CPT/HCPCS billed, test/panel name, lab name/location, clinical notes showing indication and expected use of results) may delay review or result in denial.

Required clinical notes should document that the member was advised of tests ordered, condition/suspected condition, expected use of results, prior tests, and family history as applicable.
Incomplete submissions may be subject to request for additional information or denial.

Denial Risk

Confirm statutory, NCD, and LCD exclusions before ordering

Tests excluded by statute, regulation, NCD, or LCD are not eligible for coverage and may be denied; confirm whether a test falls under NCD 90.2 or an LCD before ordering.

NCD 90.2 applies to certain NGS germline breast/ovarian tests; other tests may be excluded by LCDs or statute.
Confirm coverage determinations and any exclusions via referenced NCD/LCD documents prior to submission.

Billing Rule

Avoid unbundling or stacking panel components

Do not unbundle panel components or stack multiple Tier I molecular pathology codes to represent a single panel; such coding may be considered inappropriate and trigger denial or audit.

Bill the panel as a single service with the appropriate panel code or unlisted panel code (81479/81599) when no specific code exists.
Unbundling and stacking were identified by CMS and healthcare fraud prevention guidance as concerns for inappropriate billing.

Denial Risk

Unlisted code submissions for non‑covered services will be denied

If an unlisted code is used for a service that is non‑covered under this policy it will be denied as not covered; for potentially covered services using unlisted codes, obtain prior authorization to reduce post‑service denial risk.

All unlisted codes are reviewed for medical necessity and correct coding; prior authorization is recommended when submitting unlisted codes for potentially covered services.
If unlisted codes are submitted for non‑covered tests specifically called out by this policy, denial is the expected outcome.

Note

Policy references (Medicare/MolDX/LCD) may be used to deny nonconforming claims

References cited in this policy include Medicare manuals, MolDX LCDs/LCAs, and MAC LCDs which may be applied to deny molecular diagnostic claims that do not conform to those coverage rules.

Key referenced resources include MolDX Program Manual, Palmetto GBA DEX registry, MAC LCDs (Noridian, Palmetto, CGS, WPS), CMS Claims Processing Manuals, and NCCN guidance.
Use these references to verify coverage, coding, ordering, and documentation requirements.

Note

Eligibility Requirements — Patient and Test Constraints

To meet the general coverage criteria for multigene germline testing, the member must have no known pathogenic or likely pathogenic familial variant relevant to the requested test; when a familial pathogenic/likely pathogenic variant exists, testing should be limited to targeted analysis of the known familial variant (see the policy’s Known Familial Variant criteria).

Duplicate entry (policy requirement reiterated): coverage under the general multigene panel criteria assumes the member has no known familial pathogenic or likely pathogenic variant; if such a variant is known, the appropriate path is targeted known-familial-variant testing rather than broad panel testing.

No top-level eligibility nodes were provided in the source extract for this placeholder item.

Reiterating eligibility requirements: the general coverage pathway requires that there be no known familial pathogenic or likely pathogenic variant prior to using the multigene panel criteria; when a familial variant is known, testing should be limited to that variant (see Criterion III/KFV).

No top-level eligibility nodes were provided in the source extract for this placeholder item.

When a pathogenic or likely pathogenic variant is known in the family or a pathogenic variant is identified on tumor testing with clinical implications, germline testing should be limited to targeted analysis of the known familial variant rather than broad panel testing (i.e., perform Known Familial Variant [KFV] testing).

No top-level eligibility nodes were provided in the source extract for this placeholder item.

Not Covered — Explicit Exclusions and Billing Denials

Panels that include genes or biomarkers without demonstrated clinical validity or clinical utility, or tests that lack adequate analytical validity, may be non-covered. The policy emphasizes that tests must meet analytical and clinical validity standards and demonstrate clinical utility to satisfy Medicare reasonable-and-necessary requirements.

The policy lists numerous specific tests and vendor panels that have not met FDA clearance or MolDX technical assessment and are provided as examples of services that are not covered, including but not limited to RNAinsight™ variants, ColoSeq, COLARIS series, GeneticsNow™ (0474U), OncoDx™ (0651U), and other proprietary panels referenced in the non-covered testing sections.

Genetic testing performed solely for the purpose of screening based on family history alone (with no personal history of cancer or relevant signs/symptoms) is statutorily non-covered by Medicare and thus excluded from coverage under this policy.

Unbundled billing or stacking multiple individual component codes to represent a single panel when a specific panel code or an appropriate unlisted code (e.g., 81479, 81599) should be used is not allowed and is considered inappropriate coding that may lead to denial or audit.

The cited chunks for this group do not contain additional explicit 'not covered' labels beyond the enumerated examples and general non-coverage rules already described elsewhere in the policy.

If an unlisted code is submitted for a service that the policy defines as non-covered, the claim will be denied as not covered. Unlisted codes for potentially covered services should be accompanied by prior authorization to reduce the risk of post-service denial.

The policy includes updated language clarifying that certain repeated germline testing scenarios are non-covered; the revision history documents additions and code updates through mid-2026 reflecting those clarifications.

Definitions and Appendices

Definition — Clinical indication

Clinical indication (definition)Clinical indication: a sign, symptom, laboratory test result, medical condition, or combination that leads to recommendation of testing for a hereditary disease or condition (source: 2020 Decision Memo for NCD 90.2).

Use in documentationClinical indication should be documented in the medical record to support how test results will be used to manage the member's condition.

Role in coverage decisionsClinical indications are required alongside a treating provider order for Medicare coverage of genetic testing under Criterion I.A/B.

Definition — Risk factor (from NCD 90.2)

Risk factor (definition) — NCD 90.2 sourceRisk factor: a variable associated with increased disease risk such as age, sex, or family history of disease (source: 2020 Decision Memo for NCD 90.2).

Application to hereditary testingRisk factors (e.g., family history, early age at diagnosis) are used with clinical indications to determine testing eligibility per NCCN and Medicare criteria.

Documentation requirementProviders must document relevant risk factors in the medical record to support medical necessity for testing.

Definition — Clinical indication (duplicate)

Clinical indication (duplicate entry)Clinical indication: sign, symptom, lab test result, medical condition, or combination leading to recommendation of hereditary testing (NCD 90.2).

Used with risk factorsClinical indication must be present with an associated risk factor for Medicare to consider testing reasonable and necessary.

Referenced in Criterion BCriterion I.B requires a cancer diagnosis/personal history and both a clinical indication and risk factor per NCCN to qualify.

Definition — Risk factor (duplicate)

Risk factor (duplicate entry)Risk factor: variable associated with increased disease risk (NCD 90.2).

ExamplesExamples include age, sex, and family history; these factors are considered alongside clinical indications and tool scores for testing eligibility.

Documentation expectationDocumented risk factors must support medical necessity for testing per Medicare rules and local LCDs/MolDX guidance.

Definition — Test panel

Test panel (definition)Test panel: a predetermined set of medical tests composed of individual laboratory tests, related by medical condition, specimen type, frequency ordered, methodology or component types to aid diagnosis/treatment.

Panel typesPanels may be proprietary off‑the‑shelf (fixed gene lists) or custom panels selected by the ordering provider/genetic counselor based on patient symptoms.

Relevance requirementPanels should include genes relevant to the patient’s clinical presentation and family history to be reasonable and necessary.

Definition — MMR deficiency / Lynch-related criteria

MMR deficiency / Lynch-related criteria (definition)Clinical conditions and family history indicating increased risk for MMR gene pathogenic variants: personal history of LS-related cancer; first-/second-degree relative with LS-related cancer diagnosed <50 years; ≥2 relatives with LS-related cancer; tumor MSI-H or loss of MMR protein expression; or ≥5% risk by predictive models (MMRpro, PREMM5, MMRpredict).

Action when tumor variant foundIf a pathogenic tumor variant is identified with clinical implications, germline testing should typically be limited to the known pathogenic variant.

Reflex somatic testing roleReflex somatic tests (BRAF V600E or MLH1 promoter methylation) may be used to rule out Lynch syndrome when MLH1 loss on IHC or MSI-H is present.

Definition — Reflex somatic testing to rule out Lynch syndrome

Reflex somatic testing definitionReflex somatic testing to rule out Lynch syndrome: genetic testing for BRAF V600E or MLH1 promoter methylation may be recommended when MLH1 loss on tumor IHC or MSI-H is present.

PurposeUsed to distinguish sporadic MLH1 loss from Lynch syndrome-associated loss prior to or to inform germline testing decisions.

DocumentationResults of somatic reflex testing should be documented and may affect the scope of germline testing (limit to known variant when appropriate).

Definition — Germline hereditary cancer panel (NGS + CNV methods)

Germline hereditary cancer panel (definition)Germline hereditary cancer panel: multi-gene genomic sequence and copy-number analysis (NGS plus methods for deletions/duplications) reported per gene with variant classification in an interpretive clinical report.

Methods includedMethods include NGS for sequence variants plus complementary CNV/del‑dup methods such as MLPA, array CGH, or digital MLPA when indicated.

Specimen typesTypical specimens for germline panels include blood or saliva (some panels accept nail clipping); reporting is per gene (positive/negative) with interpretive context.

Definition — Germline panel tests and methods

Germline panel tests and methodsGermline panel tests use genomic sequence analysis (NGS), Sanger sequencing, MLPA and array CGH to evaluate multiple hereditary cancer predisposition genes and report pathogenic variants including duplications/deletions when indicated.

Reporting conventionsPanels report per-gene findings with variant classification and may include duplication/deletion results when relevant (full sequence + del/dup as shown for BRCA1/BRCA2 examples).

Examples in policyPolicy lists multiple commercial panels and associated CPT/HCPCS/U-codes illustrating these methods (e.g., OncoDx™, GeneticsNow®, ProstateNow™).

Appendix I — Family relationships definitions

Appendix I — Family relationships (definition)Defines degrees of relatives: first degree (parents, siblings, children); second degree (grandparents, grandchildren, uncles, aunts, nephews, nieces, half-siblings); third/fourth degrees as detailed in Appendix I.

Use for risk assessmentDegrees of relatives are used to interpret family history for hereditary risk assessment and testing eligibility.

Reference locationAppendix I in the policy document contains the full list and descriptions used for coverage determinations.

Appendix II — Risk stratification tools and score thresholds

Appendix II — Risk stratification tools and thresholdsLists example hereditary breast cancer risk tools and thresholds used to identify moderate/high risk: Manchester (≥15), Ontario Family History (≥10), Tyrer‑Cuzick (≥10%).

PurposeThese tools provide score-based thresholds to guide referral and testing decisions alongside clinical indications and NCCN guidance.

Integration with coverageTool scores inform but do not replace Medicare requirements (personal history and clinical indication remain necessary for coverage).

Appendices III–VI — Prostate cancer staging, prognostic groups, histologic grade groups

Appendices III–VI — Prostate cancer staging and prognostic groupsIncludes AJCC TNM staging, prognostic groups, and histologic grade group definitions used to contextualize when certain genetic tests or panels may be appropriate for prostate cancer.

Contents summaryAppendices cover clinical/pathologic T categories, regional lymph node (N) categories, distant metastasis (M), AJCC prognostic groups, and histologic grade group definitions.

Use in policyThese appendices provide staging/grading context to inform hereditary risk assessment and testing decisions in prostate cancer cases.

Revision History

2025-09policy_published

New Medicare Advantage medical policy published (Policy 443).

2025-11interim_update

Interim update adding tests, correcting typographical errors, and applying Q1 2026 code updates; added First Coast LCD and LCA for Lynch syndrome testing to Medicare references and criteria.

2026-02-13interim_update

Interim update replacing multiple MolDX LCDs and LCAs and adding a test (document notes replacement of MolDX references on 2/13/2026).

2026-04interim_update

Interim update reflecting Noridian JF consolidation with JE LCD policies and addition of a test.

2026-05interim_update

Interim update adding various inherited risk testing panels and gene expression profile tests for hereditary prostate cancer.

2026-07interim_updateLatest

Interim update with Q3 2026 code updates and revised language clarifying noncovered repeat germline testing.

Genetic and Molecular Testing for Inherited Cancer Risk

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Coverage Criteria — Medical Necessity Rules

Covered Indications — When Testing Is Allowed

Coding — CPT/HCPCS, PLA/U-codes and LCAs

Provider Actions — Ordering, Documentation, and Billing

Eligibility Requirements — Patient and Test Constraints

Not Covered — Explicit Exclusions and Billing Denials

Background — Purpose and Clinical Context

Definitions and Appendices

Revision History