CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Genomic Genetic Biomarker Testing

Defines clinical criteria and process used by Evolent (for Neighborhood Health Plan of Rhode Island lines of business) to authorize genetic, genomic, and biomarker tests when results would impact therapeutic decisions; primary sources are NCCN Biomarkers Compendium and FDA pharmacogenomic/companion diagnostic listings, with ASCO and peer-reviewed literature as secondary sources.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGenomic Genetic Biomarker Testing

Policy CodePolicy N/A

Change TypeReformatted to Evolent template (non-material)

Effective Date

Next Review Date

Key ActionSubmit requests for genetic/genomic/biomarker testing with documentation of diagnosis, stage/extent of disease, prior workup, and family history for hereditary testing; tests meeting NCCN Category 1 or 2A are authorized by Peer Clinical Reviewers, while 2B/3 require peer review and may need peer-to-peer discussion.

SourceLink

POLICY UPDATE CHANGES

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

NCCN & FDAPrimary references

Commercial/Exchange/MedicaidLines of business

1/2A vs 2B/3Authorization

Coverage Summary

Defines clinical criteria and the decision process used by Evolent to authorize genetic, genomic, and biomarker tests for Neighborhood Health Plan of Rhode Island lines of business. Primary references for determinations are the NCCN Biomarkers Compendium® and the FDA Pharmacogenomic/Companion Diagnostic listings. Applicable lines of business include Commercial, Exchange/Marketplace, and Medicaid. Tests are authorized when results would impact therapeutic decision making and meet the stated NCCN/FDA criteria; requests meeting NCCN Category 1 or 2A are authorized by Peer Clinical Reviewers, while requests with NCCN 2B or 3 require peer clinical review and possibly peer-to-peer discussion.

Key policy facts

Primary referencesUses NCCN Biomarkers Compendium and FDA Pharmacogenomic/Companion Diagnostic listings as primary criteria

Applicable lines of businessCommercial; Exchange/Marketplace; Medicaid

Authorization summaryNCCN Category 1 and 2A requests are authorized by Peer Clinical Reviewers; Category 2B and 3 require peer clinical reviewer and may require peer-to-peer discussion

SubjectGenomic/Genetic/Biomarker Testing

StatusCURRENT

Last review2025-03

Provider Requirements & Authorization Workflow

Prior Authorization

Authorization requirement

Requests for genetic/genomic/biomarker testing that meet NCCN Category 1 or 2A evidence are authorized by Peer Clinical Reviewers. Requests with NCCN Category 2B or 3 require peer clinical review and may require a peer-to-peer discussion with the requesting provider prior to a determination.

Documentation Required

Required clinical documentation

Include documentation of the patient’s diagnosis, stage and extent of disease, and the prior workup and sequencing of tests. For requests for hereditary cancer testing, document family history consistent with NCCN hereditary cancer testing guidance.

Billing Rule

Benefit determination

Coverage of tests is determined by the member’s specific health care benefit plan and may vary; meeting the clinical criteria in this guideline (NCCN/FDA-based) documents medical necessity but does not guarantee coverage under all plans.

Background & Evidence Sources

Defines key terms used in the policy: Biomarker (a biological abnormality in blood, fluids, or tissues; includes genomic and non-genomic markers), Next-Generation Sequencing (NGS) (high-throughput, massively parallel DNA sequencing of tumor tissue or circulating tumor DNA), and Genetic testing (testing for inherited gene variants and hereditary cancer syndromes).

Primary evidence sources used to determine appropriateness are the NCCN Biomarkers Compendium® and the FDA Pharmacogenomic Biomarkers listing (including the FDA list of cleared/approved companion diagnostic devices). When those primary sources are silent on a requested test or indication, secondary sources include ASCO clinical guidelines and other peer-reviewed medical literature to establish clinical validity, utility, and impact on therapeutic decision making.

Evidence item	Notes
NCCN Categories referenced	Category 1, 2A, 2B, 3 with specified consensus thresholds

Definitions

Biomarker: A specific biological abnormality found in blood, other body fluids, or tissues that is a sign of a condition or disease; may be genomic or non-genomic.

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; processes multiple DNA sequences in parallel (also called massively parallel sequencing).

Genetic testing: Looks for specific inherited changes (variants) in a person's genes and may guide individualized patient care; used to identify hereditary cancer syndromes and inherited variants that increase cancer risk.