CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Genetic Testing for Diagnosis and Management of Mental Health Conditions

This policy governs coverage and medical necessity criteria for pharmacogenomic and other genetic tests (including GeneSight and similar panels) used to diagnose or manage mental health disorders for Blue Cross Blue Shield - Rhode Island members, including BlueCHiP for Medicare and commercial products.

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 change

Effective DateOct 13, 2015

Next Review DateN/A

Key ActionObtain prior authorization for BlueCHiP for Medicare and ensure test is ordered by a licensed psychiatrist or neuropsychiatrist for eligible patients.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

GeneSightexample multiplex test

81479billing code

Medicare requiredprior auth

Not medically necessary (many)coverage stance

~26

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Coverage Criteria

Medicare - GeneSight Psychotropic covered criteria

Covered when ALL of the following are met (BlueCHiP for Medicare GeneSight psychotropic example):

BlueCHiP GeneSight coverage criteria: Test is ordered by a licensed psychiatrist or neuropsychiatrist

Clinical severity: Patient is suffering with refractory moderate to severe depression (based upon DSM‑V criteria)

Diagnosis: Diagnosed with major depressive disorder (MDD)

Prior treatment failure: Has had at least one neuropsychiatric medication failure

Management intent: Contemplating an alteration in neuropsychiatric medication

Genetic testing for mental health disorders (including multiplex pharmacogenomic panels such as GeneSight Psychotropic and other named panels) is subject to limited coverage. For BlueCHiP for Medicare, pharmacogenomic panel testing is covered only when all Medicare-specific clinical criteria are met, which include ordering by a licensed psychiatrist or neuropsychiatrist, a diagnosis of major depressive disorder (MDD) with refractory moderate to severe symptoms, at least one prior neuropsychiatric medication failure, and the clinician is contemplating an alteration in medication. In contrast, genetic testing to predict future risk, to confirm diagnosis, or to guide selection or dosing of psychotropic medications is not supported by sufficient evidence in many situations and is not covered as described below.

Services that are determined to be not medically necessary, or services that are medically necessary but are non‑covered benefits under a member’s subscriber or employer agreement, are excluded from coverage unless the member has been informed and has provided a written agreement to be financially responsible in advance.

For Commercial products, testing panels such as GeneSight Psychotropic and similar gene-panel assays are considered not medically necessary for all indications because the evidence is insufficient to demonstrate meaningful effects on health outcomes. This non‑medical‑necessity determination applies to uses including risk prediction in asymptomatic individuals, diagnostic confirmation, and informing medication selection or dosing.

When a test or service is determined to be not medically necessary, coverage will be denied and the provider may not bill the member unless the member has provided prior written agreement accepting financial responsibility. Benefits and eligibility across products and groups are governed by the member’s subscriber agreement or employer contract, which supersede this medical policy.

Covered Indications

Pharmacogenomic panel testing (Medicare eligibility for refractory MDD)

Pharmacogenomic panel testing (e.g., GeneSight Psychotropic) is covered for Medicare members when the following Medicare-specific clinical criteria for refractory major depressive disorder are met:

Ordering clinician: Test is ordered by a licensed psychiatrist or neuropsychiatrist

See CMS MolDX: GENESIGHT LCD referenced in policy

Clinical presentation: Patient meets criteria for refractory moderate to severe major depressive disorder (based upon DSM‑V criteria)

Prior treatment: Patient has had at least one neuropsychiatric medication failure

Prior medication failure required before testing

Not Covered

Not covered indications include use of genetic testing to predict future risk of a mental health disorder in an asymptomatic individual, to confirm a diagnosis in a symptomatic individual, and to inform selection or dosing of psychotropic medications (including selective serotonin reuptake inhibitors, tricyclic antidepressants, selective norepinephrine reuptake inhibitors/serotonin‑norepinephrine reuptake inhibitors, and antipsychotic drugs) because the evidence is insufficient to determine effects on health outcomes.

Eligibility Requirements

Eligibility for coverage under this policy varies by product. For BlueCHiP for Medicare, eligibility for pharmacogenomic panel testing requires that the test be ordered by a licensed psychiatrist or neuropsychiatrist and that the patient meet the clinical criteria described for refractory major depressive disorder (including documented prior medication failure and contemplated medication change). For Commercial products, these panels are generally considered not medically necessary and benefits may vary by group; refer to the member’s Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for specific coverage determinations.

Coding

Billing CPT CodeCPT

81479

Unlisted molecular pathology procedure (used for these panel tests per policy guidance)

Provider Actions & Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for BlueCHiP for Medicare and recommended for Commercial products. Participating providers must obtain prior authorization via the online tool. See related policies for details.

Prior authorization required for BlueCHiP for Medicare; recommended for Commercial products
Obtain authorization via the online tool for participating providers

Note

External LCD May Affect Prior Authorization

CMS Local Coverage Determination (MolDX: GENESIGHT for Refractory Depression, L35443) may affect prior authorization and coverage determinations. Providers should review applicable LCDs when submitting authorization requests.

External LCD (MolDX: GENESIGHT L35443) may modify prior authorization or coverage requirements

Background

Mental health disorders are heterogeneous conditions commonly treated with psychotropic medications. Clinical response to these medications is variable and often requires multiple trials. Genetic variation affecting drug metabolism and pharmacodynamics may contribute to differences in efficacy and adverse effects, but current evidence is insufficient to show consistent, clinically meaningful improvements in outcomes from routine pharmacogenomic panel testing for psychiatric indications.

Definitions

GeneSight Psychotropic — key facts

Test nameGeneSight Psychotropic

Test typeMultiplex pharmacogenomic panel analyzing alleles (SNPs) from six genes

Decision supportClinical outcomes–based decision support model that weights alleles across ~32 psychotropic drugs

Report format‘Traffic‑light’ categories (green/yellow/red) indicating likely efficacy/tolerability and drug‑drug interactions

Clinical relevanceIntended to aid therapeutic selection for psychotropic medications, with cited prospective trials showing improved patient responses

Genes and variants referenced