UnitedHealthcare CGP Companion Diagnostic Coverage

Coverage and Medical Necessity Criteria

Medically necessary CGP companion diagnostic criteria

Companion Diagnostic Tests using Comprehensive Genomic Profiling (CGP) are considered proven and medically necessary when ALL of the following criteria are met:

CGP CDx coverage criteria: Indication is listed on the FDA List of Cleared or Approved Companion Diagnostic Devices for the requested biomarker and therapeutic pairing.

Prior CGP testing: No prior Comprehensive Genomic Profiling (CGP) has been performed previously for this tumor type and stage.

Liquid biopsy conditions (when testing by ctDNA/liquid biopsy): If testing is by liquid biopsy (e.g., FoundationOne Liquid CDx CPT 0239U or Guardant360 CDx CPT 0242U), ONE of the following must be met: the individual is not medically fit for invasive biopsy; tumor tissue testing is not feasible; or ctDNA testing is the proven method for detection of the specific biomarker (for example, detection of ESR1 resistance mutations).

Supported coverage scenarios

Covered when ALL of the following are met (where the policy supports coverage based on evidence and analytic validation):

Use of FDA-approved companion diagnostics: Testing is performed using an FDA-approved companion diagnostic (for example, FoundationOne CDx) to identify biomarkers that are associated with FDA-labeled therapies and where analytic validation supports detection of the relevant biomarker.

Actionable biomarker guides therapy: Identification of specific actionable genomic alterations (for example, BRCA/DDR alterations in metastatic castration-resistant prostate cancer) is intended to guide use of targeted therapy such as PARP inhibitors after appropriate prior therapies.

Not medically necessary / investigational

Not covered or considered investigational when ANY of the following apply:

Broad molecular profiling without demonstrated clinical utility: Use of CGP or commercial broad profiling platforms (e.g., CANCERPLEX, Guardant360 TissueNext, MI Profile/MI Tumor Seek) as a general broad molecular profiling tool to direct therapy or improve outcomes when clinical utility has not been demonstrated.

Comprehensive circulating tumor DNA profiling for selection/monitoring without guideline support: Comprehensive molecular profiling of circulating tumor DNA (liquid biopsy) used broadly for treatment selection or routine monitoring in the absence of disease‑specific guideline support, or when tissue testing is available and preferred.

Covered clinical scenarios

Covered when clinical circumstances and guideline recommendations support use:

Advanced/metastatic disease with biomarker‑linked therapy: Individual has advanced or metastatic solid tumor and genomic biomarker‑linked therapies exist or testing will inform selection of an approved therapy or clinical trial eligibility (multigene panel testing recommended when eligible).

When cfDNA/liquid biopsy is appropriate: cfDNA (liquid biopsy) testing is appropriate when tumor tissue is unavailable or infeasible, or when rapid results are required and assay sensitivity is sufficient; tissue testing remains preferred when feasible.

Germline testing and counseling: Germline testing should be performed for alterations linked to approved therapies under consideration and pathogenic/likely pathogenic findings should prompt referral to genetic counseling.

Not supported indications

Not covered / limited utility when ALL of the following are present:

Early‑stage screening, routine MRD or routine monitoring: Use of ctDNA assays for early‑stage cancer screening, routine treatment monitoring, or molecular residual disease (MRD) detection lacks sufficient evidence of clinical utility and is not supported for routine practice.

Tumor-specific CGP/ctDNA coverage

Covered when meeting tumor‑specific guideline scenarios (per NCCN/other professional groups):

Tumor‑specific advanced/metastatic disease: Use of validated/FDA‑approved CGP or ctDNA testing to identify actionable somatic alterations when tissue testing is not available or feasible for individuals with locally advanced or metastatic disease (examples include ampullary, bladder, bone, breast, cervical, colorectal, gastric, NSCLC, ovarian, pancreatic, prostate cancers).

NSCLC initial diagnosis and ctDNA

Covered when ALL of the following are met for NSCLC:

NSCLC ctDNA coverage conditions: (1) Pathologic confirmation of NSCLC diagnosis has been established; (2) ONE of: the patient is not medically fit for invasive tissue sampling; insufficient tissue exists for molecular analysis (with plan for follow‑up tissue testing if cfDNA is negative); or timely tissue‑based testing is not feasible such that concurrent cfDNA testing aids treatment selection.

Companion Diagnostic Tests using Comprehensive Genomic Profiling (CGP) that do not meet the policy's specified criteria are considered unproven and not medically necessary. Specifically, tests failing to meet any of the required conditions — an indication matching an entry on the FDA List of Cleared or Approved Companion Diagnostic Devices, absence of prior CGP for the same tumor type and stage, or the liquid-biopsy-specific conditions when a ctDNA assay is used — are not supported for coverage.

Molecular screening programs that apply broad genomic profiling to guide clinical decisions outside of clinical trials are not recommended for routine practice at this time. Large cohort analyses demonstrate low implementation rates of recommended molecular-based therapies and very low objective response rates, supporting the policy position that molecular screening alone presently lacks sufficient utility to direct care outside investigational or trial settings.

Circulating tumor DNA (ctDNA) assays are not supported for routine use in early-stage cancer screening, routine treatment monitoring, or for molecular residual disease (MRD) detection as a basis for directing therapy. Professional reviews find limited evidence of clinical utility for ctDNA in early-stage disease and conclude that, although some assays have clinical validity for predicting relapse, there is no established evidence that routine MRD detection using ctDNA improves patient outcomes.

Routine use of ctDNA to detect molecular residual disease (MRD) or molecular relapse in early-stage cancer is not supported as a mechanism to direct treatment decisions. While ctDNA assays with adequate sensitivity can predict risk of future relapse, current evidence does not demonstrate that acting on these results in routine practice improves clinical outcomes; therefore routine ctDNA MRD surveillance to guide therapy is considered not medically necessary.

FDA approval or clearance of a test is informational only and, by itself, does not constitute a basis for coverage. Coverage determinations require that the use meet the policy's clinical criteria and applicable plan, state, or contractual requirements in addition to any regulatory status.

Companion Diagnostic Tests that use CGP but do not meet the policy's stated requirements (FDA-listed companion diagnostic indication, no prior CGP for that tumor type/stage, and liquid-biopsy-specific conditions when applicable) are categorized as unproven and not medically necessary and therefore not supported for coverage.

Specific commercial platforms (for example, CANCERPLEX, Guardant360 TissueNext, and Caris MI Profile/MI Tumor Seek) lack sufficient peer-reviewed evidence of clinical validity and utility as broad molecular profiling tools to direct therapy. Hayes assessments and literature reviews identified insufficient published data to support their routine use for broad profiling indications; use of these tests for that purpose is therefore not supported.

ctDNA assays are not covered for general population cancer screening, routine surveillance for MRD, or routine early-stage monitoring because current evidence does not demonstrate clear clinical validity and utility for these indications. Professional society reviews conclude that evidence is insufficient to recommend ctDNA for these uses in routine clinical practice.

ctDNA-based detection of MRD or molecular relapse in early-stage cancers currently lacks evidence that acting on these findings improves outcomes; as such, routine use of ctDNA for MRD surveillance to guide treatment decisions is considered not medically necessary.

Specific Covered Indications

CGP CDx for oncology when the indication corresponds to an FDA-cleared/approved companion diagnostic device and no prior CGP has been performed for that tumor type and stage; liquid biopsy acceptable when specified conditions met

Covered when the indication corresponds to an FDA‑cleared/approved companion diagnostic device and no prior CGP has been performed for that tumor type and stage. Liquid biopsy is acceptable when conditions below are met:

FDA companion diagnostic indication: Requested testing corresponds to a biomarker/therapy pairing listed on the FDA List of Cleared or Approved Companion Diagnostic Devices.

No prior CGP for same tumor/stage: No previous Comprehensive Genomic Profiling has been performed for this tumor type and stage.

Liquid biopsy acceptable when: If testing is via liquid biopsy (e.g., FoundationOne Liquid CDx), one of the following must apply: the patient is not medically fit for invasive biopsy; tumor tissue testing is not feasible; or ctDNA testing is the proven method for detection of the specific biomarker.

Use of FDA-approved companion diagnostics (e.g., FoundationOne CDx) to identify biomarkers linked to FDA-labeled therapies; BRCA/DDR in mCRPC for PARP use

Covered when identifying biomarkers that correspond to FDA‑labeled therapies, including use to inform targeted therapy selection:

FDA‑approved CDx used to identify therapy eligibility: Use of FDA‑approved companion diagnostics (for example FoundationOne CDx) to identify biomarkers associated with FDA‑labeled therapies is supported when analytic validation demonstrates reliable detection of the biomarker.

BRCA/DDR in mCRPC for PARP therapy: Identification of BRCA or other homologous recombination DNA repair (DDR) gene alterations in metastatic castration‑resistant prostate cancer to inform use of PARP inhibitors (supported by TRITON2 evidence).

Advanced or metastatic solid tumors when biomarker-linked approved therapies exist or to inform therapy selection or trial eligibility

Covered when ALL of the following are met for individuals with advanced or metastatic solid tumors:

Advanced/metastatic disease with biomarker‑linked approved therapies: Individual has an advanced or metastatic solid tumor AND biomarker‑linked approved therapies exist or testing results will inform selection of an approved therapy or eligibility for clinical trials.

Multigene panel testing when eligible: Multigene panel testing is recommended when the individual is eligible for genomic biomarker‑linked approved therapy; testing should be performed in an appropriately certified laboratory.

Identification of actionable somatic findings in locally advanced/metastatic tumors to guide targeted therapy or trial eligibility when tissue is not available

Covered when tissue is unavailable or infeasible and testing would identify actionable somatic findings to guide therapy or trial eligibility:

Actionable somatic findings for advanced disease when tissue not available: Identification of actionable somatic alterations (including fusions such as ALK, NRG1, NTRK, ROS1, FGFR2, RET; mutations such as BRAF, BRCA1/2, KRAS, PALB2; amplifications such as HER2; MSI/dMMR and TMB) in locally advanced or metastatic tumors to guide targeted therapy or clinical trial eligibility when tumor tissue testing is not available or not feasible.

Applicable Procedure and Coding Information

Applicable procedure codes (representative)CPT

0022U	Targeted genomic sequence analysis panel, non-small cell lung neoplasia, DNA and RNA analysis, 23 genes, interrogation for sequence variants and rearrangements, reported as presence or absence of variants and associated therapy(ies) to consider.
0037U	Targeted genomic sequence analysis, solid organ neoplasm, DNA analysis of 324 genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability and tumor mutational burden.
0179U	Oncology (non-small cell lung cancer), cell-free DNA, targeted sequence analysis of 23 genes (single nucleotide variations, insertions and deletions, fusions without prior knowledge of partner/breakpoint, copy number variations), with report of significant mutation(s).
0239U	Targeted genomic sequence analysis panel, solid organ neoplasm, cell-free DNA, analysis of 311 or more genes, interrogation for sequence variants, including substitutions, insertions, deletions, select rearrangements, and copy number variations.
0242U	Targeted genomic sequence analysis panel, solid organ neoplasm, cell-free circulating DNA analysis of 55-74 genes, interrogation for sequence variants, gene copy number amplifications, and gene rearrangements.
0473U	Oncology (solid tumor), next-generation sequencing (NGS) of DNA from formalin-fixed paraffin-embedded (FFPE) tissue with comparative sequence analysis from a matched normal specimen (blood or saliva), 648 genes, interrogation for sequence variants, insertion and deletion alterations, copy number variants, rearrangements, microsatellite instability, and tumor-mutation burden.
0543U	Oncology (solid tumor), next-generation sequencing of DNA from formalin-fixed paraffin-embedded (FFPE) tissue of 517 genes, interrogation for single-nucleotide variants, multi-nucleotide variants, insertions and deletions from DNA, fusions in 24 genes and splice variants in 1 gene from RNA, and tumor mutation burden.
81445	Solid organ neoplasm, genomic sequence analysis panel, 5-50 genes, interrogation for sequence variants and copy number variants or rearrangements, if performed; DNA analysis or combined DNA and RNA analysis.
81449	Solid organ neoplasm, genomic sequence analysis panel, 5-50 genes, interrogation for sequence variants and copy number variants or rearrangements, if performed; RNA analysis.
81450	Hematolymphoid neoplasm or disorder, genomic sequence analysis panel, 5-50 genes, interrogation for sequence variants, and copy number variants or rearrangements, or isoform expression or mRNA expression levels, if performed; DNA analysis or combined DNA and RNA analysis.

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Tumor Mutational Burden (TMB) — thresholds and evidence

Context and regulatory tie-inFDA-defined TMB cutpoint of ≥10 mutations per megabase is used to define TMB-high for pembrolizumab; KEYNOTE-158 and FDA approval specified this threshold using FoundationOne CDx.

Clinical evidence supportKEYNOTE-158 reported an objective response rate of 29% in the TMB‑high group (using ≥10 mut/Mb), supporting pembrolizumab efficacy in previously treated advanced solid tumors.

Alternative research thresholdsWhole exome sequencing analyses in pembrolizumab trials also referenced different exome-based thresholds (e.g., studies reporting ≥175 mutations/exome) when correlating mutation burden to response.

TMB‑high threshold (policy) — key value

Policy threshold>= 10 mutations/Mb is the defined threshold for TMB-high (FDA-defined cutoff used in pembrolizumab approval and KEYNOTE-158 analyses).

Assay-specific definitionTMB was assessed in KEYNOTE-158 using FoundationOne CDx with prespecified cut-point of at least 10 mut/Mb.

Clinical implicationIndividuals with TMB‑high (≥10 mut/Mb) solid tumors who progressed on prior therapy were eligible for pembrolizumab per the FDA approval context.

Provider Requirements, Documentation, and Operational Notes

Prior Authorization

Prior authorization requirement for CGP CDx — Companion diagnostic CGP tests considered medically necessary only when all listed criteria are met, including an FDA-listed companion diagnostic indication

Companion Diagnostic CGP tests are considered medically necessary only when all listed criteria are met, including that the indication has a corresponding biomarker on the FDA List of Cleared or Approved Companion Diagnostic Devices. Tests that do not meet these requirements may be denied.

Prior authorization may be required per plan rules and contracts — follow applicable authorization processes.

Note

Companion diagnostic use for FDA-labeled therapies — Use of FDA-approved companion diagnostics (e.g., FoundationOne CDx) for biomarkers associated with FDA-labeled therapies is supported

Use of FDA-approved companion diagnostics (for example, FoundationOne CDx) to identify biomarkers associated with FDA-labeled therapies is supported when used to inform therapy aligned with FDA product labeling.

Documentation Required

Coverage-related requirement for multigene panel testing — Multigene sequencing recommended for individuals with advanced/metastatic solid tumors when biomarker-linked approved therapies exist

Multigene sequencing is recommended for individuals with advanced or metastatic solid tumors when biomarker-linked approved therapies exist; document that testing will inform therapy selection and that germline testing/counseling has been discussed when relevant.

Perform multigene panel testing when genomic biomarker-associated therapies approved for the individual’s cancer exist.
Document intent to identify predetermined biomarkers associated with approved therapies and the individual’s performance status and prior treatments.

Documentation Required

Laboratory CLIA validation — For certain tumor types, testing in a CLIA-certified laboratory is recommended; confirm testing site certification

Ensure testing is performed in a CLIA-certified laboratory or other appropriately certified laboratory per guideline recommendations; confirm the testing site’s certification before ordering.

Testing must be performed in an appropriately certified laboratory (e.g., CLIA) — lack of certification may lead to nonconformance.
For some tumor types, guideline recommendations explicitly state testing in a CLIA-certified laboratory (confirm certification).

Denial Risk

Insufficient evidence triggers coverage risk — Tests or panels lacking evidence of clinical validity/utility (e.g., CANCERPLEX, Guardant360 TissueNext, MI Profile) pose coverage risk

Some commercial CGP or broad profiling assays lack sufficient published evidence of clinical validity or utility. Tests without adequate peer-reviewed support may be considered unproven and not medically necessary.

Examples of tests with insufficient evidence in available assessments include CANCERPLEX, Guardant360 TissueNext, MI Profile/MI Tumor Seek — coverage risk exists for panels lacking evidence of clinical validity/utility.

Documentation Required

Clinical documentation to support testing — Document prior treatments, performance status, tumor type, and intent to identify predetermined biomarkers

Clinical documentation must support testing and include prior treatments, performance status, tumor type/stage (advanced/metastatic when applicable), and the clinical intent to identify specific biomarkers that would inform therapy selection.

Document prior lines of therapy and disease status (e.g., progressed after standard therapy)
Document performance status and tumor histology/type
State the intended biomarkers to be evaluated and how results will affect treatment choice or trial eligibility.

Documentation Required

Clinical indication and counseling documentation — Document advanced/metastatic status and that testing will inform therapy selection; note germline testing discussion when relevant

Document that the individual has advanced/metastatic disease when that is the indication for testing, that testing will inform therapy selection, and that germline testing and referral to genetic counseling have been discussed when relevant.

Note if testing is intended to identify biomarkers linked to FDA-approved therapies and whether germline testing is indicated.
Record that pre- and post-test genetic counseling occurred and include a structured family history per LA MCO requirements.

Documentation Required

Tissue testing status — Document tumor tissue testing status and reasons for ctDNA use (e.g., tissue unavailable or unsafe)

If tumor tissue testing is not available or unsafe, document the reason for using ctDNA (liquid biopsy) and prior tissue testing status. If ctDNA is negative but clinical suspicion remains, guidelines recommend follow-up tissue testing when feasible.

Document that tissue was unavailable, unobtainable, or that biopsy was unsafe prior to ordering cfDNA testing.
If cfDNA (ctDNA) testing is negative and clinical suspicion persists, arrange tissue testing when feasible because cfDNA assays can have reduced sensitivity.

Documentation Required

Negative cfDNA results caution — cfDNA assays have compromised sensitivity with up to a 30% false-negative rate; negative results should be interpreted cautiously

Cell-free DNA (cfDNA)/ctDNA assays have high specificity but reduced sensitivity with reported false-negative rates up to ~30%; interpret negative results cautiously and consider tissue testing if clinical concern remains.

A negative ctDNA result does not exclude the presence of actionable tumor alterations due to sensitivity limitations — consider repeat or tissue-based testing as indicated.

Documentation Required

CHIP interference caution — Potential false-positive results due to clonal hematopoiesis (CHIP) when using ctDNA-only evaluations may affect interpretation

When using ctDNA-only evaluations be aware of potential false-positive results from clonal hematopoiesis of indeterminate potential (CHIP); confirm somatic origin (e.g., matched normal testing) or use tissue testing when CHIP is a concern.

Consider paired germline/normal testing or tumor tissue confirmation for variants that could reflect CHIP (especially in prostate cancer and other contexts where CHIP interference is documented).

Note

Prior authorization note — Informational; does not itself state prior authorization requirements. Follow applicable rules/contracts

Coverage determinations must reference applicable federal, state, or contractual requirements; in the event of conflict, those requirements govern. Before using this policy, check federal, state, or contractual plan terms. UnitedHealthcare may use third-party tools (e.g., InterQual) to assist in administration.

This policy provides interpretation for UnitedHealthcare standard benefit plans; always verify the member’s specific federal/state/contractual coverage terms before applying policy guidance.

Note

Implications for therapy selection — Therapy choices tied to identified biomarkers (e.g., pembrolizumab for TMB-high, PARP inhibitors for BRCA-altered mCRPC) discussed

Therapy selection should be guided by identified biomarkers where evidence and approvals exist (e.g., pembrolizumab for TMB‑high tumors, PARP inhibitors for BRCA-altered mCRPC). When biomarker-linked targeted therapies exist, prioritize approved therapies or clinical trial participation.

Document how test results would change management, including eligibility for FDA‑approved targeted agents or clinical trials.
When biomarkers predict benefit from approved agents, these options should be prioritized over unproven off‑label uses.

Note

Provider legal compliance note — Coverage decisions must reference federal, state, or contractual requirements which govern in the event of conflict

Providers must check federal, state, or contractual requirements before using this policy; UnitedHealthcare reserves the right to modify policies. This Medical Policy is informational and does not constitute medical advice.

Review applicable plan terms and legal/regulatory requirements prior to ordering tests.
UnitedHealthcare may apply third‑party clinical decision tools as part of coverage determinations.

Definitions and Terminology

Companion Diagnostic Test — definition

DefinitionA Companion Diagnostic Test provides information essential for the safe and effective use of a corresponding therapeutic drug, used to select patients for a specific therapy.

Regulatory referenceThe FDA maintains a list of cleared or approved companion diagnostic devices used to determine appropriate companion diagnostic indications.

Policy usagePolicy requires that companion diagnostic use correspond to FDA-listed companion diagnostic indications for coverage of CGP CDx.

Comprehensive Genomic Profiling (CGP) — definition

DefinitionComprehensive Genomic Profiling (CGP) is an NGS-based test able to detect all classes of genomic alterations, including mutations, copy number changes, rearrangements, MSI and TMB, from a single sample.

Typical scopeExamples include large multigene panels such as FoundationOne CDx (324 genes) used to identify actionable biomarkers and complex signatures.

Clinical roleCGP informs selection of targeted therapies, immunotherapies, and clinical trial eligibility in advanced/metastatic solid tumors when biomarker-linked therapies exist.

Liquid Biopsy — definition

DefinitionLiquid Biopsy is testing performed on bodily fluids (commonly blood) to identify tumor-derived cells or circulating tumor DNA (ctDNA), RNA, or other tumor-derived molecules.

Analytes and usesAnalyzes ctDNA, circulating tumor cells (CTCs), exosomes and other biomolecules for detection of actionable alterations, monitoring, or early detection in research contexts.

LimitationsLiquid biopsy has high specificity but variable sensitivity depending on assay and cancer stage; guidelines note up to a 30% false‑negative rate for cfDNA in some settings.

Tumor Mutational Burden (TMB) — definition and measurement context

Definition and measurementTumor Mutational Burden (TMB) is the number of mutations per megabase measured by NGS panels; assay‑specific cutpoints (e.g., ≥10 mut/Mb by FoundationOne CDx) define TMB‑high for clinical decisions.

Assay dependenceTMB values and cutpoints are assay‑dependent and were prespecified in KEYNOTE‑158 using FoundationOne CDx; FDA approval required TMB determination by an FDA‑approved test.

Clinical applicationTMB is used as a predictive biomarker for response to PD‑1 inhibition (pembrolizumab) in previously treated advanced solid tumors when meeting the defined threshold.

Liquid biopsy / ctDNA — definition

DefinitionLiquid biopsy / ctDNA refers to noninvasive testing of circulating tumor DNA in bodily fluids (commonly plasma) to detect tumor‑derived genetic alterations for diagnosis, treatment selection, or monitoring.

When to useGuidelines support ctDNA when tissue is unavailable or when rapid results are needed; tissue testing remains preferred when feasible.

Performance noteMeta-analyses and studies report reasonable diagnostic accuracy for specific mutations (e.g., KRAS) but variable sensitivity across studies and tumor types.

Liquid biopsy (cfDNA/ctDNA) — analytes and alteration classes

AnalytesLiquid biopsy analyzes circulating cell‑free tumor DNA (cfDNA/ctDNA) present in plasma or other bodily fluids.

Alteration classes detectedAssays detect single nucleotide variants (SNVs), insertions/deletions, select rearrangements/fusions, and sometimes copy number alterations depending on assay design.

Clinical limitationsCopy number and fusion detection may be limited in some ctDNA assays; assay validation and sensitivity vary by platform and alteration class.

Limit of detection (LoD) — definition and example

DefinitionLimit of detection (LoD) is the minimal variant allele fraction at which an assay reliably detects a variant (e.g., FoundationOne Liquid CDx reported a 95% LoD of 0.40% VAF for select substitutions/indels).

Assay examplesValidation studies report LoD for substitutions/indels, rearrangements, and copy number changes separately (e.g., 0.40% VAF for substitutions/indels, 0.37% for rearrangements in FoundationOne Liquid CDx).

Implication for interpretationLoD determines an assay's sensitivity for low‑frequency variants and informs caution when interpreting negative results, particularly in low tumor‑fraction samples.

ctDNA / liquid biopsy — definition and use cases

Definition and use casesctDNA (liquid biopsy) is cell‑free circulating tumor DNA in plasma used for genomic profiling when tissue is unavailable or rapid results are needed; it can identify actionable somatic alterations in advanced cancers.

Guideline stanceESMO and IASLC support use of ctDNA when assays have sufficient sensitivity and as an alternative or complement to tissue testing in selected scenarios.

Cautionary pointsBecause cfDNA assays can have compromised sensitivity (up to ~30% false-negative rate per NCCN), negative ctDNA results should prompt follow‑up tissue testing when feasible.

Comprehensive genomic profiling (CGP) — definition

DefinitionComprehensive genomic profiling (CGP) refers to large NGS‑based multigene tumor panels that assess multiple biomarker classes (mutations, fusions, amplifications, MSI, TMB) to identify actionable targets.

Typical platformsExamples of CGP platforms include tissue‑based FoundationOne CDx (324 genes) and other large panels used to detect a broad set of actionable genomic alterations.

Clinical roleCGP is recommended for individuals with advanced/metastatic solid tumors when biomarker‑linked approved therapies exist or when results will influence therapy selection or trial eligibility.

Companion Diagnostic — FDA‑cleared/approved IVDs used to select patients for therapies

DefinitionCompanion Diagnostic — an FDA‑cleared or approved in vitro diagnostic device used to select patients for a particular therapy, often identified via the FDA list of cleared/approved companion diagnostics.

Policy implicationPolicy requires companion diagnostic indications to match FDA‑listed companion diagnostics for coverage of CGP companion diagnostic testing.

ExampleFoundationOne CDx has FDA companion diagnostic indications for multiple therapies and includes biomarkers such as TMB and MSI in its reports.

CLIA — Clinical Laboratory Improvement Amendments of 1988 definition/reference

DefinitionCLIA (Clinical Laboratory Improvement Amendments of 1988) is the regulatory framework that governs laboratories that perform genetic tests in the United States.

Regulatory roleLaboratories that perform genetic testing should be appropriately certified under CLIA; the policy references CLIA as the laboratory regulatory reference.

Policy noteTesting performed in appropriately certified laboratories (e.g., CLIA/CAP) is recommended; lack of certification may affect coverage or conformance with recommendations.

OpenPayer

Molecular Oncology Companion Diagnostic Testing (for Louisiana Only)

Coverage and Medical Necessity Criteria

Specific Covered Indications

Applicable Procedure and Coding Information

Provider Requirements, Documentation, and Operational Notes

Member and Test Eligibility Requirements

Services and Uses Not Covered

Definitions and Terminology

Background and Evidence Summary