CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Genetic/Genomic/Biomarker (Tumor Marker) Testing

Defines clinical criteria and authorization process for serum, tissue, genetic, genomic and biomarker tests (including NGS and companion diagnostics) when results would impact therapeutic decision-making, using NCCN Biomarkers Compendium and FDA pharmacogenomic listings as primary references.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGenetic/Genomic/Biomarker (Tumor Marker) Testing

Policy CodePolicy N/A

Change TypeAdministrative/template and naming updates

Effective Date

Next Review Date

Key ActionProvide documentation of diagnosis, stage/extent of disease, sequencing of prior tests, and family history as applicable and submit requests per Evolent authorization procedures; tests with NCCN category 1 or 2A are authorized by Peer Clinical Reviewers while 2B or 3 require peer review and may need peer-to-peer discussion.

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1394 guideline (March 2025).

Updated vendor/entity name from NCH verbiage to Evolent (March 2024).

NCCN & FDAPrimary Evidence Sources

2B/3Conditional Reviews

Commercial/Medicaid/MA/CHIP/ExchangeLines of Business

Coverage Summary

Subject: Genetic/Genomic/Biomarker (Tumor Marker) Testing. Status: CURRENT. Lines of business: Commercial, Medicaid, Medicare Advantage, CHIP, Exchange.

Scope summary: Defines clinical criteria and authorization process for serum, tissue, genetic, genomic and biomarker tests (including NGS and companion diagnostics) when results would impact therapeutic decision-making; covered with criteria using NCCN Biomarkers Compendium and FDA Pharmacogenomic Biomarkers listing as primary references.

Key values

SubjectGenetic/Genomic/Biomarker (Tumor Marker) Testing

Coverage stancecovered_with_criteria

Primary evidence sourcesNCCN Biomarkers Compendium and FDA Pharmacogenomic Biomarkers listing

Conditional review notePeer review required for requests with NCCN Category 2B or 3; Category 1 or 2A authorized by Peer Clinical Reviewers

Lines of BusinessCommercial, Medicaid, Medicare Advantage, CHIP, Exchange/Marketplace

Effective/Last review datesLast review: 2025-03; Effective date: (not specified)

Medical Necessity / Authorization Criteria

General Authorization Criteria

Tests are authorized when ALL of the following are met:

ALL of the following

The test request is appropriate per the NCCN Biomarkers Compendium and/or FDA Pharmacogenomic Biomarkers listing for the patient’s condition (disease matches Disease Description and requested test matches Molecular Abnormality and Gene Symbol fields).
The patient's diagnosis, stage and extent of disease and appropriate workup and sequencing of tests align with the NCCN Recommendation: Clinical Decision field.
For genetic testing for suspected hereditary cancer syndrome, NCCN guidelines and/or the patient's family history support the request.
The NCCN Category of Evidence and Consensus is 1 or 2A.
Authorization pathway
- Requests that meet category 1 or 2A evidence are authorized by Peer Clinical Reviewers.
- Requests with category 2B or 3 require clinical review and/or peer discussion and may result in approval or adverse determination.

Provider Actions & Authorization Process

Prior Authorization

Authorization required when criteria apply

All submitted requests for genetic, genomic, and biomarker testing follow Evolent authorization and determination policies and timeframes. Tests that meet NCCN Category 1 or 2A evidence are authorized by Peer Clinical Reviewers. Requests with NCCN Category 2B or 3 require clinical review and/or peer discussion and may result in approval or an adverse determination.

NCCN Category 1 or 2A = authorized by Peer Clinical Reviewers
Category 2B or 3 = requires clinical review/peer discussion; may result in approval or adverse determination.

Documentation Required

Documentation of diagnosis and clinical rationale

Providers must document the patient’s diagnosis, stage and extent of disease, the sequencing/ timing of prior tests and workup, and family history when hereditary cancer is suspected to demonstrate alignment with NCCN/FDA listings and to support medical necessity.

Patient diagnosis
Stage and extent of disease
Sequencing and timing of prior tests and appropriate workup
Family history for suspected hereditary cancer syndrome

Background and Definitions

Background: A biomarker is a biological abnormality in blood, other body fluids, or tissues that signals a condition or disease and may be genomic or non-genomic. Next-Generation Sequencing (NGS) is a high-throughput method to analyze the genome using massively parallel DNA sequencing. Genetic testing looks for inherited gene variants that can increase cancer risk (contributing to about 5–10% of cancers). Hereditary cancer syndromes are inherited disorders with higher-than-normal risk of certain cancers (examples: hereditary breast and ovarian cancer syndrome, Li-Fraumeni, Cowden, Lynch).

Authorization rationale: Evolent authorizes genetic, genomic, and biomarker tests when results would impact therapeutic decision-making and peer-reviewed literature or clinical evidence supports the need for testing; companion diagnostics and pharmacogenomic biomarkers maintained by the FDA are used as part of the decision framework.

Term	Definition
Biomarker	A specific biological abnormality found in blood, other body fluids, or tissues that is a sign of a condition or disease; includes genomic and nongenomic abnormalities.
Next-Generation Sequencing (NGS)	A high-throughput method used to analyze the genome (DNA) of tumor tissue and/or circulating tumor cells or cell-free DNA; utilizes DNA sequencing technologies capable of processing multiple DNA sequences in parallel (also called massively parallel sequencing).
Genetic Testing	Testing that looks for specific inherited gene variants; may guide individualized patient care. Harmful inherited variants are associated with increased cancer risk and are thought to contribute to about 5 to 10% of all cancers.
Hereditary Cancer Syndrome	A type of inherited disorder with a higher-than-normal risk of certain cancers caused by gene aberrations passed from parents to children; family cancer patterns and examples include hereditary breast and ovarian cancer syndrome, Li-Fraumeni syndrome, Cowden syndrome, and Lynch syndrome.

Evidence: Primary guidance is the NCCN Biomarkers Compendium and the FDA Pharmacogenomic Biomarkers listing; if those sources are silent for a requested test or indication, Evolent will use ASCO clinical guidelines and other peer-reviewed literature to determine clinical criteria and medical necessity.