DraftBlue Cross Blue Shield - Rhode IslandPolicy N/A

Biomarker testing (genetic & molecular testing) coverage and medical necessity

State-mandated coverage guidelines and medical necessity criteria for biomarker testing addressing Commercial Products and Medicare Advantage Plans; explains medical criteria, prior authorization requirements, panel testing rules, and coding guidance. This part is the first of two documents and contains general policy, definitions, background, and instructions about where specific criteria and code grids are found.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyBiomarker testing (genetic & molecular testing) coverage and medical necessity

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 1, 202620d

Next Review DateMar 18, 2028

Key ActionSubmit prior authorization requests via the BCBSRI online prior authorization tool or fax to Utilization Management when a test is not listed; for multi-code panels, request authorization for each CPT code individually.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3primary genetic testing categories with general criteria included

2024-01-01statutory coverage effective date reference in mandate (policies delivered or renewed on/after)

Multiplecoverage outcomes referenced (covered, not medically necessary, not covered)

65+

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Medical Necessity Criteria for Biomarker and Genetic Testing

General medical necessity for carrier screening (preconception or prenatal)

Carrier screening is medically necessary when ALL of the following are met:

ALL of the following

One or both individuals have a first- or second-degree relative who is affected
One individual is known to be a carrier
One or both individuals are members of a population known to have a carrier rate that exceeds a threshold considered appropriate for testing for a particular condition
Previous carrier screening or individual targeted gene testing for the gene variant(s) of interest has not been performed

General medical necessity for genetic screening/testing for genetic or hereditary conditions (germline)

Genetic screening/testing is medically necessary when the diagnostic test will benefit the individual and ONE of the following is met:

ANY of the following

To confirm a suspected diagnosis in a patient with signs and/or symptoms of the condition
To identify a causative etiology for a clinical syndrome with multiple possible underlying conditions
Testing an asymptomatic individual to determine future risk of disease

General medical necessity for genetic testing for cancer

Genetic testing for cancer is medically necessary when ONE of the following is met:

ANY of the following

Testing an asymptomatic patient to determine future risk of cancer
Therapeutic testing of cancer cells from an affected individual to direct targeted treatment based on specific somatic variants

Panel testing coverage rule

Panel tests are subject to additional criteria and rules:

ALL of the following

Prior authorization is required for each component and/or gene/gene variant of panel testing when the panel is represented by multiple CPT codes; each individual CPT code must be entered and processed independently in the online authorization tool
Enter and process each CPT code independently in the BCBSRI online authorization tool; fax requests if test not in tool
If there is insufficient evidence that an individual gene/gene variant in a panel is useful for guiding management and improving net health outcomes, then the entire genetic panel test is considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products
When evidence is lacking for one or more panel components, the entire panel is treated as not covered (Medicare Advantage) or not medically necessary (Commercial)

Code Categories and Guidance

Coding guidance and attached code gridsmixed

No codes listed

Code categories referenced in document (grids attached elsewhere)mixed

PLA	Proprietary Laboratory Analyses (PLA) codes; proprietary/ADLT/CDLT tests
MAAA	Multianalyte Assays with Algorithmic Analyses
Molecular Pathology / Genomic Sequencing Procedures (GSP)	CPT/HCPCS molecular pathology and sequencing codes; code selection based on specific genes analyzed

Prior Authorization, Documentation, and Billing Rules

Prior Authorization

Use online prior authorization tool or fax for authorization requests

Submit prior authorization requests for biomarker testing using the BCBSRI online prior authorization tool if you are a participating provider. Non‑participating providers must fax prior authorization requests to Utilization Management at (401) 272‑8885. If the requested biomarker test is not available in the online tool, fax the request to Utilization Management at (401) 272‑8885.

Prior Authorization

Panel testing authorization for multi-code panels

For panels represented by multiple CPT codes, obtain prior authorization for each individual CPT code; each code must be entered into and processed independently through the online authorization tool.

Documentation Required

Laboratories not permitted to obtain authorization on behalf of ordering physician

Clinical and Regulatory Context

This policy implements the Rhode Island biomarker testing mandates (R.I.G.L. §27-19-81 and §27-20-77) which require coverage for biomarker testing when tests demonstrate clinical utility — for example, via labeled indications for an FDA-approved or -cleared test, CMS National/Local Coverage Determinations, or nationally recognized clinical practice guidelines and consensus statements. The mandates require insurers to provide coverage for biomarker testing for diagnosis, treatment, appropriate management, or ongoing monitoring when clinical utility is established, while minimizing disruptions in care (eg, unnecessary repeat biopsies) and providing an accessible exceptions process for patients and prescribers (see statutory definitions and requirements).

For purposes of this policy, biomarker is defined per statute as an objectively measured characteristic indicating normal biological processes, pathogenic processes, or pharmacologic responses (including gene mutations or protein expression), and biomarker testing includes analysis of tissue, blood, or other biospecimens using single-analyte tests, multiplex panel tests, and whole genome/exome sequencing.

The policy defines major biomarker testing categories used in clinical practice: molecular pathology procedures — nucleic acid analyses (DNA/RNA) to detect germline or somatic variants with code selection based on specific genes analyzed; genomic sequencing procedures (GSPs) and other molecular multianalyte assays — massively parallel/NGS-based methods that assay multiple genes, exomes, or genomes; Proprietary Laboratory Analyses (PLA) — proprietary/ADLT/CDLT tests reported with PLA codes; and Multianalyte Assays with Algorithmic Analyses (MAAA) — assays that combine multiple analytes and algorithmic scoring to produce numeric results or probabilities.

Genetic testing scope includes both germline variants (present in every cell and potentially heritable) and somatic variants (acquired, present in subsets of cells such as tumors). Biomarker testing use cases covered by this policy include carrier screening (preconception/prenatal), germline testing for hereditary or genetic conditions, and genetic testing for cancer (including therapeutic tumor testing to inform targeted treatment).

Key Terms

Definitions

BiomarkerA characteristic objectively measured as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention (includes gene mutations or protein expression).

Biomarker testingAnalysis of a patient's tissue, blood, or other biospecimen for the presence of a biomarker, including single-analyte tests, multiplex panel tests, and whole genome sequencing.

Clinical utilityThe test result provides information that is used in the formulation of a treatment or monitoring strategy that informs outcome and impacts clinical decision-making.

First-degree relativeBiological parent, brother, sister, or child.

Second-degree relativeBiologic grandparent, aunt, uncle, niece, nephew, grandchildren, and half-sibling.

PLAProprietary Laboratory Analyses — proprietary/advanced diagnostic laboratory tests with PLA codes.

Policy Dates and Revision Notes

Effective date: 07|01|2026. Policy last reviewed: 03|18|2028.

This document is Part 2 of 2 and provides general state-mandated coverage guidelines, definitions, and instructions for biomarker testing for Commercial Products and medical necessity context for Medicare Advantage Plans. Coding grids and test-specific criteria are provided in the attached coding resources and the BCBSRI online authorization tool.

Published provider communications related to these requirements include Provider Updates in January and May 2026 and prior communications in 2025 and 2023; providers should verify member-specific benefits and follow the prior authorization submission instructions in the policy (online tool or fax) when applicable.