CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Genetic Testing for Diagnosis and Management of Mental Health Conditions

Policy governing coverage and prior authorization requirements for commercially available pharmacogenomic and mental-health-related genetic testing panels for diagnosis and drug management of mental health conditions for BCBSRI members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyGenetic Testing for Diagnosis and Management of Mental Health Conditions

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateApr 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization via the payer's online tool for Medicare Advantage members before ordering testing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

7listed commercial test panels addressed

GeneSightSpecific panel covered under criteria

81479Billing code required

Prior authAuthorization required (MA)

Multiple testsNot covered / insufficient evidence

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

GeneSight Psychotropic (Medicare Advantage)

Covered when ALL of the following are met

Medicare Advantage GeneSight coverage: Member has a diagnosis of a mental health condition

GeneSight Psychotropic panel may be considered medically necessary when these criteria are met.

Medicare Advantage GeneSight coverage: Member has failed at least one prior medicationfailed at least one prior medication

Testing to inform drug selection for treatment of a diagnosed mental health condition when member has failed at least one prior medication (Medicare Advantage, GeneSight Psychotropic).

Covered indication (Medicare Advantage): Member has a diagnosed mental health condition AND testing is intended to inform drug selection

Member must have failed at least one prior medication.

Prior medication requirement: Member has failed at least one prior medicationfailed at least one prior medication

See coding/thresholds for definition of prior medication failure.

Commercial product stance — The following tests are considered not medically necessary due to insufficient evidence

The following tests are considered not medically necessary due to insufficient evidence

Not medically necessary panels (commercial): Genecept Assay (Genomind) OR GeneSight Psychotropic panel (Assurex Health) OR NeuroIDgenetix (AltheaDx) OR Mental Health DNA Insight Panel (Pathway Genomics) OR Neuropharmagen (AB-Biotics) OR Proove Opioid Risk Assay (Proove Biosciences) OR STA 2 R - SureGene Test for Antipsychotic and Antidepressant Response (SureGene)

Listed as not medically necessary for Commercial products due to insufficient evidence to demonstrate improved net health outcome.

Medicare Advantage not covered — The following tests are not covered for Medicare Advantage members

The following tests are not covered for Medicare Advantage members

Not covered panels (Medicare Advantage): Genecept Assay (Genomind) OR NeuroIDgenetix (AltheaDx) OR Mental Health DNA Insight Panel (Pathway Genomics) OR Neuropharmagen (AB-Biotics) OR Proove Opioid Risk Assay (Proove Biosciences) OR STA 2 R - SureGene Test for Antipsychotic and Antidepressant Response (SureGene)

Listed as not covered due to insufficient evidence to demonstrate improved net health outcome.

Several commercially available pharmacogenomic and mental-health genetic panels are explicitly identified in this policy as either not covered for Medicare Advantage members or not medically necessary for Commercial products because the evidence is insufficient to demonstrate improved net health outcome. Tests named in the policy include: Genecept Assay (Genomind), GeneSight Psychotropic panel (Assurex Health), NeuroIDgenetix (AltheaDx), Mental Health DNA Insight Panel (Pathway Genomics), Neuropharmagen (AB-Biotics), Proove Opioid Risk Assay (Proove Biosciences), and STA 2 R / SureGene Test for Antipsychotic and Antidepressant Response (SureGene).

If services are determined to be not medically necessary or to be non-covered benefits, providers may not bill the member for those services unless the member was informed in advance and has agreed in writing to proceed at their own expense; providers should also consult the member's subscriber agreement, member certificate, employer agreement, and applicable participation agreements for billing provisions.

Coding

Unlisted CPT code for panel testingCPT

81479

Unlisted molecular pathology procedure

Prior medication failure — failed at least one prior medication

Eligibility conditionMember has failed at least one prior medication (required for Medicare Advantage coverage of GeneSight Psychotropic)

Applies toMedicare Advantage members for GeneSight Psychotropic panel

DocumentationFailure of prior medication should be documented in the medical record (clinical note showing inadequate response or intolerance)

Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Medicare Advantage Plans and is obtained via the payer's online tool for participating providers. Laboratories are not permitted to obtain clinical authorization or participate in the authorization process on behalf of the ordering physician; only the ordering physician shall be involved in authorization, appeals, or other administrative processes related to prior authorization/medical necessity.

All Unlisted genetic testing CPT codes require prior authorization to determine what service is being rendered and whether the service is covered or not medically necessary.
If a laboratory provides a laboratory service that has not been authorized, the service will be denied and the financial liability will fall to the participating laboratory; the laboratory may not bill the member.
If a laboratory or third party is found to have supported any portion of the authorization process (including preparation of documentation), BCBSRI will consider this a policy violation and may take severe action up to termination from the BCBSRI provider network.

Note

Verify Member Benefits

Verify member-specific benefits and eligibility prior to ordering testing. Coverage and payment are dependent on the member's subscriber agreement, member certificate, or employer agreement, which will supersede this medical policy. For information on member-specific benefits, contact the provider call center.

Not Covered / Not Medically Necessary

The policy lists multiple specific panels as not covered or not medically necessary because current evidence does not demonstrate an improvement in net health outcome. These panels are: Genecept Assay (Genomind), NeuroIDgenetix (AltheaDx), Mental Health DNA Insight Panel (Pathway Genomics), Neuropharmagen (AB-Biotics), Proove Opioid Risk Assay (Proove Biosciences), and STA 2 R - SureGene Test for Antipsychotic and Antidepressant Response (SureGene). The GeneSight Psychotropic panel is additionally listed as not medically necessary for Commercial products but may be considered medically necessary for Medicare Advantage members when specific coverage criteria are met.

Background

Genetic variation can influence both risk for psychiatric disorders and individual differences in drug metabolism, therapeutic response, and adverse effects. Pharmacogenomic testing aims to identify clinically relevant variants that may inform medication selection or dosing, but clinical utility requires evidence from intervention studies showing that test-directed management improves patient health outcomes compared with usual care. Clinical practice guidance such as CPIC genotype-based dosing recommendations for antidepressants and tricyclic antidepressants is referenced in the evidence base, and laboratories offering these tests must meet CLIA high-complexity standards.

Definitions

Laboratory-developed test (LDT)

DefinitionTests developed and validated in clinical laboratories and offered as a laboratory service (laboratory-developed tests, LDTs)

Regulatory requirementLaboratory-developed tests must meet CLIA regulatory standards and laboratories offering LDTs must be licensed by CLIA for high-complexity testing

ContextLDTs discussed in this policy are available under the auspices of CLIA; FDA review has not been required for these tests

Clinical utility

DefinitionEvidence that use of the test to make management decisions alters clinical outcomes compared with standard care

Preferred evidenceDirect evidence from intervention studies, preferably randomized controlled trials