CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1394

Genomic/Genetic/Biomarker (Tumor Marker) Tests Coverage Criteria

Defines clinical criteria and authorization process for genetic, genomic, and biomarker tests (serum and tissue) for oncology patients covered under Neighborhood Health Plan of Rhode Island, using NCCN Biomarkers Compendium and FDA pharmacogenomic listings as primary guidance.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGenomic/Genetic/Biomarker (Tumor Marker) Tests Coverage Criteria

Policy CodePolicy UM ONC_1394

Change TypeNo material changes

Effective DateMar 31, 2023

Next Review Date

Key ActionObtain authorization for genetic/genomic/biomarker tests when results would impact therapeutic decision-making and are supported by NCCN, FDA, or peer-reviewed evidence.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

NCCN & FDAPrimary evidence sources for coverage decisions

1 or 2AAuthorized NCCN levels

2B or 3Levels needing peer review

Commercial/Exchange/MedicaidLines of business

Coverage Criteria & Clinical Necessity

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Medical necessity criteria

Covered when ALL of the following are met:

Primary coverage conditions: (1) Results of the requested genetic, genomic, or biomarker test would impact therapeutic decision‑making; (2) Clinical evidence supports the need for testing and the request is supported by the NCCN Biomarkers Compendium and/or FDA Pharmacogenomic Biomarkers listing (if those sources are silent, ASCO or other peer‑reviewed literature may be used); (3) The patient’s diagnosis matches the NCCN Disease Description field and the requested test matches the Molecular Abnormality and Gene Symbol fields; (4) The patient’s diagnosis stage, extent of disease, and prior workup/test sequencing align with the NCCN Clinical Decision recommendations; (5) For suspected hereditary cancer syndrome testing, NCCN hereditary testing guidelines and/or relevant family history support the request.

Requests meeting NCCN Category 1 or 2A are authorized by peer clinical reviewers; requests with NCCN Category 2B or 3 require clinical peer review and may require peer‑to‑peer discussion.

Benefit coverage for genetic, genomic, and biomarker testing depends on the member’s specific health care benefit plan. This policy defines the clinical criteria used to determine medical necessity for those tests but does not replace plan-specific coverage or benefit limitations. Authorization decisions require that the requested test and indication meet the clinical criteria described herein and be consistent with the member’s benefits.

Indications Covered by Policy

Tumor or blood-based genomic testing — evidence-based therapeutic impact

Covered when ALL of the following are met:

Tumor/blood genomic testing conditions: (1) Results would impact therapeutic decision‑making; (2) The requested test and indication are supported by the NCCN Biomarkers Compendium and/or FDA Pharmacogenomic Biomarkers listing; (3) If NCCN or FDA listings are silent for the test/indication, supportive evidence from ASCO clinical guidelines or other peer‑reviewed literature is available; (4) The patient’s diagnosis and NCCN fields (Disease Description, Molecular Abnormality, Gene Symbol) match the request; (5) The patient’s disease stage, extent, and prior testing sequence conform to the NCCN Clinical Decision recommendations.

Authorization pathway: requests meeting NCCN Category 1 or 2A are authorized by peer clinical reviewers; requests with NCCN Category 2B or 3 require clinical peer review and may require peer‑to‑peer discussion.

Genetic testing for suspected hereditary cancer syndromes

Covered when ALL of the following are met:

Hereditary cancer testing conditions: (1) Request is for genetic testing to evaluate a suspected hereditary cancer syndrome; (2) Testing is indicated per applicable NCCN hereditary testing guidelines and/or the patient’s family history supports the request; (3) The patient’s clinical presentation, family history, and NCCN Disease Description/Molecular Abnormality fields align with the requested test; (4) Appropriate sequencing of prior workup and testing as outlined in the NCCN Clinical Decision recommendations has been followed.

Requests consistent with NCCN Category 1 or 2A are authorized by peer clinical reviewers; requests with NCCN Category 2B or 3 require peer clinical review and may require peer‑to‑peer discussion.

Authorization, Evidence, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Authorization is required when test results would impact therapeutic decision-making and are supported by clinical evidence. Requests meeting NCCN/FDA or other authoritative guidance (see evidence sequencing below) require prior authorization; requests with NCCN Category 1 or 2A evidence are routinely authorized by Peer Clinical Reviewers.

Authorization required when results would impact therapeutic decision-making
Requests with NCCN Category 1 or 2A evidence authorized by Peer Clinical Reviewers

Note

Evidence Sequencing for Clinical Decision

Use the following evidence hierarchy when determining whether testing will inform clinical decision-making: 1) NCCN Biomarkers Compendium and FDA Pharmacogenomic Biomarkers listing (primary criteria); 2) if those sources are silent, reference ASCO clinical guidelines and peer-reviewed literature; 3) supplementary sources may include FDA Companion Diagnostic listings and other peer-reviewed studies to establish clinical validity, utility, and potential to impact care.

Primary: NCCN Biomarkers Compendium and FDA Pharmacogenomic Biomarkers
Secondary: ASCO Clinical Guidelines and peer-reviewed literature
Supplementary: FDA Companion Diagnostic listings and other peer-reviewed sources

Documentation Required

Required Clinical Documentation

All requests must include documentation demonstrating that the patient's diagnosis matches the Disease Description and that the requested test corresponds to the Molecular Abnormality/Gene Symbol and intended indication. For hereditary cancer testing, include supporting NCCN guideline language and/or pertinent family history consistent with a suspected hereditary cancer syndrome. Documentation should also show disease stage, extent of disease, prior workup, and sequencing of prior tests per NCCN recommendations.

Diagnosis matched to Disease Description field
Requested test matched to Molecular Abnormality and Gene Symbol fields
For hereditary testing: NCCN guideline support and/or relevant family history
Documentation of diagnosis, stage, extent of disease, prior workup, and sequencing of tests

Denial Risk

Risk of Denial When Evidence Criteria Not Met

Requests that lack evidence the results would impact therapeutic decision-making or that are not supported by the primary sources above may be denied. Requests with NCCN Category 2B or 3 require peer clinical reviewer evaluation and may require peer-to-peer discussion; absence of adequate supporting documentation or failure to meet evidence criteria increases risk of an adverse determination.

High risk of denial when testing would not affect therapeutic decisions or lacks support from NCCN/FDA/ASCO or peer-reviewed evidence
Category 2B or 3 requests require peer clinical review and may need peer-to-peer discussion before determination
Incomplete documentation consistent with required elements may lead to denial

Member & Test Eligibility

Requests are considered appropriate when the following are met: the patient’s diagnosis matches the Disease Description field and the requested test matches the Molecular Abnormality and Gene Symbol fields in the NCCN Biomarkers Compendium; and the patient’s diagnosis, stage, extent of disease, and prior workup/testing sequence align with the NCCN Clinical Decision recommendations.

For hereditary cancer syndrome testing, the request must be supported by NCCN hereditary testing guidelines and/or relevant family history. Coverage decisions prioritize listings in the NCCN Biomarkers Compendium and the FDA Pharmacogenomic Biomarkers list; when those sources are silent, ASCO and other peer-reviewed literature are used to establish clinical appropriateness.

Background and Definitions

Genomic and biomarker tests analyze tumor tissue and/or blood (including circulating tumor DNA) to identify DNA-level abnormalities that can inform diagnosis, prognosis, and therapeutic decisions. Testing modalities include next-generation sequencing (NGS) panels, companion diagnostics tied to specific drug approvals, and inherited genetic testing for suspected hereditary cancer syndromes. Authorization and clinical use are guided primarily by the NCCN Biomarkers Compendium and FDA pharmacogenomic listings, with ASCO and peer-reviewed literature used when those primary sources are silent.

Biomarker / Genomic tests / NGS definitions and attributes

BiomarkerA specific biological abnormality found in blood, other body fluids, or tissues that is a sign of a condition or disease; may be used to prevent, diagnose, or treat a condition and/or assess treatment response.

Genomic tests / Biomarker analysisTests performed on tumor tissue and/or blood (including circulating tumor DNA) to identify DNA‑level (genomic) abnormalities that may guide diagnosis, prognosis, and therapeutic decisions.

Next‑Generation Sequencing (NGS)A high‑throughput (massively parallel) DNA sequencing method used to analyze the genome of tumor tissue or circulating tumor cells/cell‑free DNA to detect multiple DNA sequences in parallel.

Companion diagnosticsA specific test required prior to approval of a specific drug/agent; considered a subset of biomarker tests tied to therapeutic agents.

Genetic testing (germline)Testing that looks for inherited gene variants passed from parents to children; harmful variants are associated with increased cancer risk and account for an estimated 5–10% of cancers.

Hereditary cancer syndrome / Genetic testing

DefinitionHereditary cancer syndromes are inherited disorders caused by aberrations or structural changes (e.g., mutations) in certain genes that increase the risk of specific cancers; these syndromes often show familial clustering, early age of onset, or multiple primary cancers.

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

Clinical presentationPatterns may include multiple affected first‑degree relatives (e.g., mother, daughter, sister) with the same cancer type, early‑age onset of cancer, or an individual with two or more primary cancers.

Genetic testing purposeGenetic testing identifies inherited variants to guide individualized patient care and assess increased cancer risk related to hereditary syndromes.

OpenPayer

Genomic/Genetic/Biomarker (Tumor Marker) Tests Coverage Criteria

Coverage Criteria & Clinical Necessity

Indications Covered by Policy

Authorization, Evidence, and Documentation Requirements

Member & Test Eligibility

Exclusions and Not Covered Tests

Background and Definitions