CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Genomic/Genetic/Biomarker/Tumor Marker Tests

Criteria and procedure for authorization of genetic, genomic, and biomarker tests used to inform therapeutic decision-making for members of Neighborhood Health Plan of Rhode Island (via Evolent guidelines). Applies to providers requesting serum and tissue molecular testing.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGenomic/Genetic/Biomarker/Tumor Marker Tests

Policy CodePolicy N/A

Change TypeTemplate conversion and verbiage update

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and ensure documentation shows the requested test and diagnosis align with NCCN Biomarkers Compendium or FDA listings.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1394 guideline.

Updated NCH verbiage to Evolent.

NCCN 1 or 2AEvidence categories that authorize testing without extra peer discussion

2B or 3Evidence categories requiring peer clinical review and possible peer-to-peer

NCCN & FDAPrimary sources for clinical criteria

Commercial/Exchange/MedicaidApplicable lines of business listed

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Coverage and Medical Necessity Criteria

Coverage for genetic, genomic, and biomarker testing is determined by the member's specific health care benefit plan. This document describes the clinical criteria and medical necessity requirements used by the payer to evaluate test requests but does not itself define or alter the terms of any insurance contract or benefit coverage.

Testing requests that do not meet the clinical criteria in this policy may be denied. Examples include tests for which results would not be expected to impact therapeutic decision-making or tests that lack supporting evidence in the NCCN Biomarkers Compendium®, FDA Pharmacogenomic Biomarkers listing, or applicable peer-reviewed guidance. Requests that remain at NCCN Category 2B or 3 without peer clinical reviewer support will require further review and may result in an adverse determination.

Indications Considered Medically Necessary

Coding and Evidence Categories

Codesmixed

No codes listed

NCCN Category of Evidence and Consensus

Categories listedCategory 1, 2A, 2B, 3

Category 1 definitionBased upon high-level evidence, there is uniform NCCN consensus (85%) that the intervention is appropriate.

Category 2A definitionBased upon lower-level evidence, there is uniform NCCN consensus (85%) that the intervention is appropriate.

Authorization ruleRequests with NCCN Category 1 or 2A meeting clinical criteria are authorized by Peer Clinical Reviewers.

2B/3 handlingTesting requests with NCCN Category 2B or 3 require clinical review and/or peer discussion prior to determination.

Provider Requirements, Documentation, and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization required. Genetic, genomic, and biomarker test requests are authorized when results would impact therapeutic decision‑making and clinical evidence supports testing (NCCN Biomarkers Compendium® category 1 or 2A, FDA Pharmacogenomic Biomarkers listing, or equivalent peer‑reviewed guidance). Requests meeting NCCN Category 1 or 2A are authorized by Peer Clinical Reviewers. Requests with NCCN Category 2B or 3 require peer clinical reviewer assessment and may require peer‑to‑peer discussion with the requesting provider before a determination is issued.

NCCN Category 1 or 2A: authorized by Peer Clinical Reviewers
NCCN Category 2B or 3: requires peer clinical reviewer assessment; may require peer-to-peer discussion
All authorizations follow standard determination timeframes and notification processes

Documentation Required

Required Documentation to Support Medical Necessity

Documentation must demonstrate that the requested test is clinically indicated and will influence patient management. Provide records showing: diagnosis that matches the Disease Description; the requested test corresponds to the Molecular Abnormality and Gene Symbol; disease stage, extent of disease, and prior workup/sequencing of tests per the NCCN Clinical Decision recommendations; and, when hereditary cancer testing is requested, supporting family history or adherence to NCCN hereditary testing guidance. Include relevant peer‑reviewed evidence or FDA/NCCN citations when the indication is not explicitly listed.

Diagnosis mapped to Disease Description field
Requested test maps to Molecular Abnormality / Gene Symbol fields
Documentation of stage, extent of disease, and prior testing/workup per NCCN Clinical Decision
For hereditary cancer testing: family history and/or NCCN hereditary testing criteria

Step Therapy

Step Therapy Not Defined

Step therapy is not defined for genetic/genomic/biomarker testing decisions. Coverage and testing decisions follow NCCN and FDA criteria, applicable clinical guidelines (e.g., ASCO), and peer review pathways rather than a step‑therapy sequencing requirement.

Decisions guided by NCCN/FDA and peer‑reviewed literature, not step therapy sequencing

Denial Risk

Denial Triggers

Requests may be denied if submitted documentation does not show that test results would impact therapeutic decision‑making, if the requested test/indication is not supported by NCCN/FDA/peer‑reviewed literature, or if required documentation (diagnosis, test mapping, staging, family history when applicable) is missing.

Insufficient evidence that results would impact treatment decisions
Lack of support in NCCN, FDA, or peer‑reviewed literature
Missing required clinical documentation

Note

Peer Review and Provider Responsibilities

When peer clinical review is required (e.g., NCCN Category 2B or 3 or when NCCN/FDA are silent), the reviewer will assess clinical validity, utility, and whether the test result would alter management. No specific ordering provider type is mandated; peer review and potential peer‑to‑peer discussion standards apply.

Peer clinical reviewer assessment required for certain evidence categories
No specific ordering provider type mandated

Documentation Required

Genetic Counseling and Hereditary Testing Expectations

If genetic testing for a suspected hereditary cancer syndrome is requested, providers are expected to address genetic counseling implications and document that counseling was provided or offered per NCCN guidance.

Document genetic counseling provided or offered when hereditary testing is pursued
Ensure family history and NCCN hereditary testing criteria are addressed

Member and Test Eligibility

Authorization decisions require documentation that the patient's diagnosis corresponds to the NCCN "Disease Description" for the indication and that the requested test corresponds to the "Molecular Abnormality" and "Gene Symbol" entries in the NCCN Biomarkers Compendium®. The patient's diagnosis, stage, extent of disease, and prior workup must align with the NCCN Clinical Decision recommendations for the requested use.

For requests for hereditary cancer genetic testing, eligibility requires that testing is supported by applicable NCCN guidelines and/or that the patient's family history is consistent with criteria for hereditary testing per NCCN recommendations.

Exclusions and Non-Covered Services

NOT COVERED: Tests are not authorized when there is insufficient evidence that results would impact therapeutic decision-making or when the requested test/indication is not supported by the NCCN Biomarkers Compendium®, FDA Pharmacogenomic Biomarkers listing, or relevant peer-reviewed literature. Specific tests that fail to meet these requirements are excluded from authorization and may be denied.

Background and Rationale

Biomarkers encompass both genomic and non-genomic abnormalities identified in tumor tissue or blood, including circulating tumor DNA, that can inform diagnosis, prognosis, and therapy selection. Genetic testing identifies inherited variants associated with hereditary cancer syndromes, which represent a minority of cancers but have implications for individualized patient care and familial risk assessment.

Definitions

Biomarker

DefinitionA specific biological abnormality found in blood, other body fluids, or tissues that is a sign of a condition or disease; term generally interchangeable with molecular marker.

UsesMay be used to help prevent, diagnose, or treat a condition and/or to monitor response to treatment.

ScopeIncludes genomic (e.g., EGFR mutation) and non-genomic (e.g., PD-L1 expression) abnormalities.

Next-Generation Sequencing (NGS)

DefinitionA high-throughput method used to analyze the genome (DNA) of tumor tissue and/or circulating tumor cells or cell-free DNA; capable of processing multiple DNA sequences in parallel (also called massively parallel sequencing).

Specimen typesPerformed on tumor tissue and/or circulating tumor DNA in blood.

SynonymAlso referred to as NGS (Next-Generation Sequencing) or massively parallel sequencing.

Genetic testing

DefinitionTesting that looks for specific inherited changes (variants) in a person's genes and may be used to guide individualized patient care.

Clinical relevanceHarmful variants in some genes are associated with increased cancer risk and are thought to contribute to about 5–10% of all cancers.

Result implicationsVariants can be harmful, beneficial, or have no effect; results inform risk assessment and management decisions.

Hereditary Cancer Syndrome

DefinitionAn inherited disorder in which gene aberrations passed from parents confer a higher-than-normal risk of certain cancers, often producing characteristic family patterns (multiple relatives with same cancer, early onset, or multiple primary cancers in an individual).

ExamplesHereditary breast and ovarian cancer syndrome, Li-Fraumeni syndrome, Cowden syndrome, Lynch syndrome.

Pattern recognitionFamily history patterns—several close relatives with same cancer, early age at onset, or two or more cancers in one person—support suspicion of a hereditary cancer syndrome.