CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Biomarkers

Defines coverage criteria, limitations, and authorization requirements for biomarker testing and pharmacogenetic multi-gene panels (>=5 genes) for Neighborhood Health Plan of Rhode Island members across listed product lines, with exclusions and Medicare distinctions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBiomarkers

Policy CodePolicy N/A

Change TypeRevised (reviewed 2/11/26)

Effective DateJan 1, 2024

Next Review Date

Key ActionSubmit prior authorization requests using Neighborhood's prior authorization forms on the provider website or call 1-800-963-1001; provide documentation of a face-to-face visit within 30 days or Tumor Board/specialist recommendation to support coverage.

SourceLink

POLICY UPDATE CHANGES

Policy reviewed and updated on 2/11/26 with effective date 2/11/26 noted in metadata.

1Covered specific use (antidepressant/antipsychotic guidance)

MultipleExcluded uses (e.g., pain, ADHD, cardiovascular)

5-15Allowed gene panel size for covered indication

30 daysRequired face-to-face visit timeframe

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This policy defines coverage for pharmacogenetic biomarker testing and Pharmacogenetic Multi-Gene Panels (5 or more genes) for Neighborhood Health Plan of Rhode Island members across applicable product lines. It covers multi-gene panels when used to guide treatment with antidepressant and/or antipsychotic medications under specified criteria and excludes use for other indications (e.g., pain, ADHD, cardiovascular) or tests that are experimental or part of clinical trials. The intended population is members with psychiatric diagnoses being considered for antidepressant/antipsychotic therapy — coverage is limited/mixed (proven for the defined antidepressant/antipsychotic use; unproven for other indications).

Quick Reference — Thresholds & Key Facts

Multi-Gene Panel gene count>= 5 genes and <= 15 relevant genes

Required face-to-face visit timeframeDocumentation of face-to-face visit with ordering physician within the last 30 days

Covered specific use (count)1 (antidepressant/antipsychotic guidance)

Excluded uses (count)Multiple (e.g., pain, ADHD, cardiovascular drugs)

Allowed gene panel size for covered indication5-15 genes

Policy effective dates1/1/24 and 2/11/26

Medical‑Necessity Criteria

General Evidence-Based Services Coverage Determination

Requests for Evidence Based Services are covered ONLY when ALL of the following criteria are met:

ALL of the following

The requested service or item is safe and effective
The requested service or item is not experimental or investigational, and is supported by medical and scientific evidence
The requested service or item is within accepted standards of medical practice
The requested service or item is appropriate to the medical needs and condition of the member in the current clinical scenario
The requested service or item is not specifically excluded by another Clinical Medical Policy or treatment guideline
Documentation of clinical encounter
- Documentation has been provided showing a face-to-face visit with the ordering physician within the last 30 dayswithin the last 30 days
- There is confirmation that testing has been recommended by a Tumor Board or consulting specialist
Purpose of the test
- The test will confirm or rule out a diagnosis
- The results of the test are necessary to determine the correct treatment plan
- The test is required to prevent, diagnose, monitor, or treat complications resulting from participation in a clinical trial
The requested service or item is ordered and furnished by qualified personnel

Pharmacogenetic Multi-Gene Panels (5 or more genes) — Medically Necessary for antidepressant/antipsychotic guidance

Pharmacogenetic Multi-Gene Panels (5 or more genes) are considered proven and medically necessary for guiding treatment with antidepressants and/or antipsychotic medications when ALL of the following criteria are met:

ALL of the following

The individual has a diagnosis of major depressive disorder or generalized anxiety disorder
The individual has trialed and failed at least one prior medication to treat their condition
The Multi-Gene Panel has no more than 15 relevant genes>=5 and <=15
Panel gene-count threshold

Not Medically Necessary / Experimental

Exclusions and Limitations — Not Medically Necessary / Unproven

The following are considered unproven and not medically necessary:

ANY of the following

Requests for biomarker testing that is the subject of a clinical trial or experimental protocol
Use of pharmacogenetic Multi-Gene Panels (5 or more genes) for any indication other than guiding treatment with antidepressant and/or antipsychotic medication (examples include pain management, ADHD, cardiovascular drugs, anthracyclines, or polypharmacy)
Specific example panels considered unproven: GeneSight® Analgesic, GeneSight® ADHD, Pain Medication DNA Insights®, PharmacoDx, SureGene Test
Use of the PrismRA® molecular signature test for evaluating likelihood of inadequate response to anti-TNF therapies for rheumatoid arthritis

Examples of named commercial tests that are considered unproven and not medically necessary when used for non‑antidepressant/antipsychotic indications include GeneSight® Analgesic, GeneSight® ADHD, Pain Medication DNA Insights®, PharmacoDx, SureGene Test. Use of panels outside the covered antidepressant/antipsychotic indication (for example, for pain management, ADHD, cardiovascular drugs, anthracyclines, or polypharmacy) is explicitly considered unproven and may be denied.

Provider Actions

Prior Authorization

Prior authorization required via provider forms

Providers must submit authorization requests using Neighborhood's prior authorization request forms available on the provider website. For assistance or to ask questions, phone Neighborhood at 1-800-963-1001.

Use Neighborhood prior authorization request forms available at www.nhpri.org → Providers → Provider Resources → Forms → 'Click here for a list of prior authorization request forms'.
Phone assistance: 1-800-963-1001.

Documentation Required

Clinical documentation requirement

Coverage requires documentation of a recent clinical encounter: either a face-to-face visit with the ordering physician within the last 30 days OR confirmation that testing was recommended by a Tumor Board or a consulting specialist. Include this documentation with the authorization request to meet coverage criteria.

Face-to-face visit with the ordering physician within the last 30 days (required unless tumor board/consultant confirmation provided).
OR written confirmation that testing was recommended by a Tumor Board or consulting specialist.

Denial Risk

Denial risk for experimental/unsupported testing

Tests that are experimental, investigational, part of a clinical trial, or ordered for indications not supported by evidence (examples include pain management, ADHD, cardiovascular drugs, anthracyclines, or polypharmacy) are considered unproven and not medically necessary and may be denied.

Experimental or clinical-trial biomarker testing is excluded.
Use of multi-gene pharmacogenetic panels for non‑approved indications (e.g., pain, ADHD, cardiovascular drugs) is unproven and may be denied.

Background

Pharmacogenetic testing assesses genetic variations that can affect drug targets or metabolism and therefore influence medication efficacy and safety. The purpose is to identify polymorphisms that may predict drug response and guide selection and dosing of medications. Because clinical utility varies by indication, the policy limits coverage to multi‑gene panels used to guide antidepressant/antipsychotic treatment and sets parameters (e.g., panel sizes and prior therapy requirements) to ensure tests are clinically appropriate and consistent with accepted standards of care.

A Pharmacogenetic Multi‑Gene Panel is defined as a genetic test assessing multiple genes (5 or more) simultaneously to guide medication selection and dosing.

Revision History

2023-12-06review

CMP review and Medical Director approval on 12/6/23; associated with policy review cycle.

2024-01-01effective

Policy effective date 1/1/24 as listed in metadata.

2026-02-11review_and_updateLatest

Policy reviewed and updated on 2/11/26 with CMP review and Medical Director approval on 2/11/26; effective date 2/11/26 noted in metadata. Policy change: updated coverage determinations and criteria per documented review.