EmblemHealth Gene Expression Profiling Coverage Update

Coverage Criteria and Test Listings

I. Advanced cancer, FDA-cleared/approved NGS companion diagnostics

Covered when ALL of the following are met for Advanced cancer NGS companion diagnostics:

Advanced cancer NGS companion diagnostic criteria: 1) Member has either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer; AND 2) Member has not been previously tested using the same NGS test for the same cancer genetic content; AND 3) Member has decided to seek further cancer treatment (e.g., therapeutic chemotherapy); AND 4) The diagnostic laboratory test using NGS has FDA approval or clearance as a companion in vitro diagnostic; AND 5) The test has an FDA approved or cleared indication for use in that patient's cancer; AND 6) Results are provided to the treating physician for management using a report template that specifies treatment options.

See List of Cleared or Approved Companion Diagnostic Devices to match test with drug.

III. Guardant360 LDT for NSCLC (Commercial)

Covered when ALL of the following are met for Guardant360 LDT in NSCLC (Commercial members, non-companion indications):

Guardant360 LDT criteria for Commercial members: 1) Diagnosis of metastatic or recurrent non-small cell lung cancer (NSCLC); AND 2) NSCLC diagnosis confirmed by histopathologic assessment of tumor tissue; AND 3) No previous multi-gene panel testing has been performed for NSCLC; AND 4) Insufficient tumor tissue is available for broad molecular profiling and the member is unable to undergo an additional standard tissue biopsy due to documented medical reasons (invasive tissue sampling contraindicated).

Medicare members follow the LCD: Plasma-Based Genomic Profiling in Solid Tumors.

Medicare/MCG-based coverage sections

Covered per referenced LCD/MCG criteria:

Medicare-specified LCD/MCG coverage: IV. NSCLC and metastatic colorectal cancer tumor tissue genomic panels are covered for Medicare per the Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms LCD (e.g., OncoVantage®); AND V. Hematolymphoid disease genomic panels are covered for all lines of business per the Genomic Sequence Analysis Panels in the Treatment of Hematolymphoid Diseases LCD; AND X. Whole exome/genome sequencing is covered when MCG medically-necessary criteria sets apply (A-0866, A-0871, A-0872, A-0926, A-0870 for the listed indications).

Specific LCD and MCG IDs are referenced in the policy text.

VI & VIII. Prostate and Transplant testing

Covered tests with specified criteria for prostate cancer and transplant monitoring:

Prostate cancer biomarker coverage: 4Kscore, ConfirmMDx, and ExoDx Prostate (EPI) are covered for Commercial and Medicare using criteria from Billing and Coding: Biomarker Testing for Prostate Cancer Diagnosis; Genomic Prostate Score (formerly Oncotype DX) is covered for Medicare per the Prostate Cancer Genomic Classifier Assay LCD (commercial coverage discontinued Feb. 1, 2023); Prolaris and Decipher are covered for Commercial and Medicare to guide management of localized or biochemically recurrent prostate cancer when life expectancy is ≥ 10 years; IsoPSA is covered for members ≥ 50 years with PSA > 4 and ≤ 25 ng/mL and life expectancy ≥ 10 years.

See respective LCD/Billing and Coding criteria for detailed eligibility.

Transplant rejection testing: AlloMap (heart) and AlloSure (heart, kidney, lung) are covered for applicable members for transplant rejection monitoring.

IX. DecisionDx-UM

Covered when ALL of the following are met for DecisionDx-UM:

DecisionDx-UM criteria: 1) Member has primary, localized uveal melanoma; AND 2) There is no evidence of metastatic disease; AND 3) No previous DecisionDx-UM testing has been performed after the current diagnosis when a result was successfully obtained.

Covered for Commercial and Medicare members.

IX. Covered / Investigational test listings

Tests are listed with coverage designations; many entries reference Medicare and Commercial coverage and MCG criteria.

Test Listings: Multiple specific tests are listed in the policy as covered for Commercial and/or Medicare or noted as investigational; see the policy test list for individual determinations. Examples include Guardant360 LDT and Guardant360 CDx (covered Commercial and Medicare; see Sections III and I), myChoice CDx (covered Commercial and Medicare), MSK-IMPACT (covered for Medicare), Signatera (covered for Medicare), Prolaris (covered Commercial and Medicare), Oncotype MAP PanCancer Tissue Test (covered for Medicare), and numerous other MCG-referenced panels and proprietary tests.

Refer to the policy's test listing sections (chunks 18-22) for complete designations and cross-references to LCD/MCG criteria.

Gene expression profiling (GEP) is not considered medically necessary when the test lacks documented analytical/clinical validity and clinical utility. Specifically, GEP will be denied where the result has not been shown to impact medical management (for example, changes to surgery, surveillance, chemotherapy, or hormonal therapy) or where evidence of validity is insufficient to support clinical use.

Confirmation testing solely to replicate results from consumer-directed services (e.g., Health + Ancestry [23andMe]) is considered experimental/investigational and not of clinical value unless the member independently meets the clinical criteria in this policy. The policy also includes a noncoverage statement added previously clarifying noncoverage of tests performed only to confirm consumer-based results.

Sequencing of panels that include more than 50 genes for hereditary cancer testing is not considered medically necessary when the member does not have a personal or family history of cancer. The policy clarifies this threshold and states such broad hereditary panels are unproven and lack sufficient therapeutic value in the absence of relevant history.

Whole exome sequencing (WES) and whole genome sequencing (WGS) are not considered medically necessary for a set of broad indications, including population-based screening, cancer testing solely to identify targeted therapies, preimplantation genetic diagnosis/screening, invasive prenatal (fetal) testing, products of conception/pregnancy loss, and testing for chromosomal rearrangements. The policy references MCG criteria for specific, limited WES/WGS indications where coverage may apply.

For Medicaid members, tests billed with proprietary lab analysis (PLA) codes (codes ending in 'u') listed in the policy are not covered because PLA codes are not reimbursed by New York State Medicaid. The policy provides examples of PLA companion diagnostic codes (e.g., FoundationOne CDx 0037U, Guardant360 CDx 0242U) and reiterates that PLA-coded tests will be denied for Medicaid members.

Proprietary lab analysis (PLA) codes are not covered for Medicaid members. In addition, CPT procedure codes that are not listed on the applicable New York State Medicaid Lab Fee Schedule are not covered. Providers should confirm Medicaid billability before submitting claims for PLA or non-schedule CPT codes.

The policy lists numerous named gene expression profiling (GEP) tests and proprietary panels that are considered not medically necessary due to insufficient evidence of therapeutic benefit. Examples include (but are not limited to) 23andMe Health + Ancestry, BluePrint®, BREVAGen/BREVAGenplus, DecisionDx tests (e.g., DiffDx - Melanoma, Glioblastoma, SCC in certain contexts), BreastOncPx™, and many vendor-specific hereditary and somatic panels. See the policy’s Not Medically Necessary list for the full set of named tests and exceptions.

The policy reiterates that sequencing more than 50 genes for hereditary cancer testing in the absence of a personal or family cancer history is unproven and not medically necessary. This clarification was added to emphasize the coverage threshold and to direct requests to case-by-case review only when personal or family history suggests multiple inherited cancer syndromes or prior limited testing was non-diagnostic.

Specific Covered Indications

Advanced/metastatic/relapsed/refractory cancer and DecisionDx-UM (summary)

Covered indications summarized:

Advanced/metastatic/relapsed/refractory cancer with FDA-cleared companion diagnostics: Advanced, metastatic, relapsed, or refractory cancers (stage III/IV) are covered when testing is performed with an NGS diagnostic that is FDA-approved or cleared as a companion IVD and meets the policy's other specified criteria (see Section I); DecisionDx-UM is covered for primary localized uveal melanoma when its specific criteria are met.

See Sections I and IX for full criteria and required reporting to the treating physician.

Medicare or Commercial coverage for specific tests

Medicare or Commercial coverage exists for numerous named tests when policy or referenced LCD/MCG criteria are met:

Examples of tests with Medicare or Commercial coverage: Examples include Oncotype MAP PanCancer Tissue Test (covered for Medicare), Prolaris (covered for Commercial and Medicare), myChoice CDx (covered for Commercial and Medicare), MSK-IMPACT (covered for Medicare), Signatera (covered for Medicare), and many additional MCG-listed tests. Coverage depends on the indication and referenced LCD/MCG criteria.

Eligibility Requirements for Testing

Coverage for hereditary cancer sequencing panels that include more than 50 genes is contingent on documentation of a qualifying personal or family history of cancer. In the absence of such history, panels exceeding this gene-count threshold are considered not medically necessary. Requests may be reviewed on a case-by-case basis when the history suggests multiple inherited cancer syndromes or when prior limited testing was negative but clinical suspicion persists.

No additional top-level eligibility requirement nodes were identified in the source text beyond the criteria and clarifications already stated elsewhere in the policy.

The policy does not specify a sequence of prior tests that must be performed before ordering most listed genetic or molecular tests. Prior testing requirements, when present, are listed within individual test-specific criteria (for example, prior limited testing or absence of previous identical NGS testing is referenced for certain indications).

Provider Actions, Documentation, and Billing Guidance

Documentation Required

Documentation Submission Requirement

The treating physician or primary care provider must submit to EmblemHealth the clinical evidence that the member meets the criteria for the requested test or treatment. Without this documentation, EmblemHealth will not be able to properly review the request for preauthorization or perform post-payment review. Failure to submit required clinical evidence may result in denial of the request.

Treating physician or primary care provider must submit clinical evidence demonstrating member meets criteria.
Results of diagnostic tests (e.g., FDA-cleared companion diagnostic NGS reports) must be provided to the treating physician for patient management.
If clinical evidence is not provided, the request may not be properly reviewed and may be denied.

Prior Authorization

Preauthorization and FDA Companion Diagnostic Matching

Preauthorization is required where indicated by the guideline and must include submission of clinical evidence demonstrating eligibility per the guideline and matching to any applicable FDA companion diagnostic when relevant.

Coding, PLA and Medicaid Billing Notes

Named PLA/companion diagnostic codes (examples)CPT

0037U	FoundationOne CDx
0239U	FoundationOne Liquid CDx
0242U	Guardant360 CDx
0023U	LeukoStrat CDx FLT3
0172U	myChoice® CDx
0022U	Oncomine Dx Target Test
0111U	Praxis Extended RAS Panel
0154U	therascreen FGFR RGQ RT-PCR Kit
0155U	therascreen PIK3CA RGQ PCR Kit (tumor tissue)
0177U	therascreen PIK3CA RGQ PCR Kit (plasma)

Named PLA/companion diagnostic codes (examples) - group sourceCPT

No codes listed

Gene count threshold for hereditary cancer testing

ThresholdSequencing of more than 50 genes for hereditary cancer is not considered medically necessary without a personal or family history of cancer.

ScopeApplies to hereditary cancer gene panels where the gene count exceeds 50 genes.

Effective clarification dateNov 14, 2025 (clarification added stating >50 genes without personal/family cancer history is unproven and not medically necessary)

Policy actionTests exceeding this gene-count threshold require documented personal or family cancer history to be considered medically necessary.

Not Medically Necessary / Investigational Tests

The Not Covered section explicitly names a set of GEP tests and panels considered not medically necessary. This includes many proprietary and vendor-named tests (see policy list) such as 23-Gene NGS Pyruvate Metabolism and Related Disorders Panel, 23andMe Health + Ancestry Service, BluePrint®, BreastNext®, and numerous comprehensive NGS panels. Providers should consult the full list in the policy when determining coverage.

The revision history notes that Guardant Shield was removed from the investigational list on Apr 10, 2026. The policy also reiterates that PLA/proprietary lab analysis codes are not reimbursed for Medicaid members and that CPT codes not on the New York State Medicaid Lab Fee Schedule are not covered for Medicaid members.

Definitions and Background

Gene expression profiling (GEP) identifies which genes are active in a tissue sample and can provide diagnostic and prognostic information. The guideline covers GEP alongside gene sequencing and other molecular techniques and ties coverage decisions to demonstration of analytical validity, clinical validity, and clinical utility. When GEP results meaningfully affect medical management, testing may be considered; otherwise, GEP is not supported by the evidence and is excluded.

Gene expression profiling (GEP) — definition

DefinitionGene expression profiling (GEP) is a technology for identifying the genes that are active in a given sample of cells or tissue, enabling profiling of genes that are differentially expressed in disease states to provide diagnostic and prognostic information.

PurposeProvides diagnostic and prognostic information by measuring patterns of gene activity in tissue samples.

Policy relevanceGEP is included in this guideline and is subject to coverage determinations based on analytical/clinical validity and clinical utility.