CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy Genetic Testing for Diagnosis and Management of Mental Health Conditions

Defines medical necessity, prior authorization, covered vs not-covered commercial and Medicare Advantage coverage positions for specific pharmacogenomic panels used to guide drug selection/dosing in mental health conditions, lists coding and documentation requirements.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Genetic Testing for Diagnosis and Management of Mental Health Conditions

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateOct 1, 2023

Next Review Date

Key ActionObtain prior authorization for GeneSight (CPT 0345U) and any Unlisted molecular pathology CPT (81479) via the online tool for participating providers and document medical necessity and medication plan in the medical record.

SourceLink

POLICY UPDATE CHANGES

No material changes to clinical coverage or policy criteria (has_material_change=false).

8Tests named in policy

2Panels possibly covered when criteria met

5Panels listed as not covered / not medically necessary

Coverage Summary

This policy takes a mixed coverage stance: certain pharmacogenomic panels are covered for Medicare Advantage (when medical criteria are met) and some panels or uses are not covered for Commercial products. Medicare Advantage plans may cover the GeneSight Psychotropic panel (CPT 0345U) and the Psychotropic Pharmacogenomics gene panel (often filed with CPT 81479) when the specified medical criteria and documentation requirements are satisfied. IDgenetix (CPT 0411U) is listed as covered for both Medicare Advantage and Commercial products. Several named panels (e.g., Genecept/Genomind, Mental Health DNA Insight, Neuropharmagen, STAR SureGene, Proove Opioid Risk) are listed as not covered for Medicare Advantage and/or not medically necessary for Commercial products per the policy.

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Policy Metadata

PayerBlue Cross Blue Shield - Rhode Island

PolicyGenetic testing for diagnosis and management of mental health conditions (pharmacogenomic panels)

Policy CodeN/A

Effective Date2023-10-01

Last Review2023-09-29

StatusCURRENT

Key ActionDefines medical necessity, prior authorization, covered vs not-covered commercial and Medicare Advantage coverage positions for specific pharmacogenomic panels used to guide drug selection/dosing in mental health conditions, lists coding and documentation requirements.

Medical Necessity Criteria

GeneSight Psychotropic Panel (CPT 0345U) - Medicare Advantage Plans

May be considered medically necessary when ALL six of the following criteria are met:

ALL of the following

ONE of
- Schizophrenia
- Schizophreniform disorder
- Major Depressive Disorder (MDD)
- Social phobia, generalized
- Anxiety disorders
- Panic disorder [episodic paroxysmal anxiety]
- Post-traumatic stress disorder
- Bipolar disorder
- Obsessive-compulsive personality disorder
- Attention-deficit hyperactivity disorder (ADHD)
Medication therapy is considered or is already administered
Non-genetic factors are used to make preliminary medication selection
Documentation that the test is required to define safe use of the drug in the individual
Must meet A or B
- A Initial Testing (ALL of the following)
  - When medication therapy is being considered (has not already been administered), documentation must include that testing is to define safe use of the drug in the individual
  - Medication is medically necessary, appropriate and approved for use with specific diagnosis
  - Medication is known to have a gene(s)-drug interaction that has been demonstrated to be clinically actionable
  - Selection of medication must be derived from clinical factors/necessity rather than from testing
  - Test results are necessary for safe administration or dosing of medication
- B Additional Testing (ALL of the following)

Psychotropic Pharmacogenomics Gene Panel (CPT 81479) - Medicare Advantage Plans

May be considered medically necessary when ALL six of the following criteria are met:

ALL of the following

ONE of
- Schizophrenia
- Schizophreniform disorder
- Bipolar disorder
- Social phobia, generalized
- Anxiety disorders

Not Covered / Not Medically Necessary Tests

The policy explicitly lists the following tests as not covered / not medically necessary in the contexts specified: Genecept (Genomind) Assay, Mental Health DNA Insight (Pathway Genomics) panel, Neuropharmagen (AB-Biotics), STAR SureGene Test for Antipsychotic and Antidepressant Response (SureGene), and Proove Opioid Risk (Proove Biosciences) Assay. Additionally, GeneSight Psychotropic is indicated as not medically necessary for Commercial products but may be considered medically necessary for Medicare Advantage when the policy’s clinical criteria are met. Coverage therefore differs by product (Medicare Advantage vs Commercial) and by specific panel.

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Test / Panel	Coverage Status	Notes
IDgenetix (CPT 0411U; 15-gene panel including CYP2D6 del/dup)	Covered	Covered for Medicare Advantage and Commercial products (CPT 0411U new code effective 10/01/2023; for dates of service prior to 10/01/2023 use 81479).
GeneSight Psychotropic (CPT 0345U; 15-gene panel)	Covered for Medicare Advantage when criteria met; Not covered for Commercial products	Medicare Advantage: may be medically necessary when specified criteria are met (prior auth required). Commercial: listed as not medically necessary. Code effective 10/01/2022; use 81479 for earlier dates of service.
Unlisted molecular pathology procedure (CPT 81479) for other panels/dates of service prior to specific CPT codes	Covered	Use 81479 for panels without a specific CPT or for dates of service prior to effective dates of specific CPT codes; prior authorization required when 81479 is used.
Genecept (Genomind) Assay	Not covered / Not medically necessary (Medicare Advantage and/or Commercial as specified)	Listed as not covered for Medicare Advantage and not medically necessary for Commercial plans (evidence insufficient to demonstrate improvement in net health outcome).
Mental Health DNA Insight (Pathway Genomics) panel	Not covered / Not medically necessary	Listed as not covered for Medicare Advantage and not medically necessary for Commercial plans.
Neuropharmagen (AB‑Biotics)	Not covered / Not medically necessary	Listed as not covered for Medicare Advantage and not medically necessary for Commercial plans.
STAR SureGene Test for Antipsychotic and Antidepressant Response (SureGene)	Not covered / Not medically necessary	Listed as not covered for Medicare Advantage and not medically necessary for Commercial plans.
Proove Opioid Risk (Proove Biosciences) Assay	Not covered / Not medically necessary	Listed as not covered for Medicare Advantage and not medically necessary for Commercial plans.
GeneSight Psychotropic panel (Commercial products) [contrast]	Not medically necessary (Commercial)	Specifically noted as not medically necessary for Commercial Products, contrasting with Medicare Advantage coverage when criteria are met.

Coding

Covered CPT - Medicare Advantage & Commercial (IDgenetix)CPTCovered

0411U

IDgenetix (15 gene panel including deletion/duplication analysis of CYP2D6) - New code effective 10/01/2023; for dates of service to 10/01/2023, use 81479

Covered CPT - GeneSight Psychotropic (when criteria met)CPTCovered

0345U

GeneSight Psychotropic panel (genomic analysis panel, variant analysis of 15 genes including deletion/duplication analysis of CYP2D6) - Code effective 10/01/2022; for dates of service to 10/01/2022, use 81479

Covered CPT - Unlisted molecular pathology procedure for other panelsCPTCovered

81479

Unlisted molecular pathology procedure - used for other panels/dates of service prior to specific CPT codes

Not covered / Not medically necessary tests (Medicare Advantage and/or Commercial as specified)mixedNot Covered

	Genecept (Genomind) Assay - listed as not covered due to insufficient evidence
	Mental Health DNA Insight (Pathway Genomics) panel - not covered / not medically necessary
	Neuropharmagen (AB-Biotics) - not covered / not medically necessary
	STAR SureGene Test for Antipsychotic and Antidepressant Response (SureGene) - not covered / not medically necessary
	Proove Opioid Risk (Proove Biosciences) Assay - not covered / not medically necessary
	GeneSight Psychotropic panel - listed as not medically necessary for Commercial Products (may be medically necessary for Medicare Advantage when criteria met)

Provider Actions

Prior Authorization

Prior authorization required for GeneSight (0345U) and unlisted CPTs

Prior authorization is required for the GeneSight Psychotropic Panel (CPT 0345U) and for any Unlisted molecular pathology CPT (81479) when those codes are used for tests referenced in this policy. Prior authorization for participating providers must be obtained via the online tool.

0345U
81479
Note: Prior auth via online tool for participating providers

Documentation Required

Documentation of medical necessity and medication plan

The medical record must document the diagnosis for which pharmacologic therapy is reasonable and necessary, the drug(s) being considered and their indication, that non-genetic factors were used for preliminary medication selection, and that the test is required to define safe use or dosing of the drug in the individual.

Billing Rule

Filing claims with correct CPT depending on DOS

File claims using the CPT that corresponds to the date of service: use CPT 0345U for the GeneSight Psychotropic panel for dates of service on or after 10/01/2022 (for earlier dates file with 81479); use CPT 0411U for IDgenetix for dates of service on or after 10/01/2023 (for earlier dates file with 81479). If no specific CPT applies, file with unlisted molecular pathology code 81479.

0345U — GeneSight: use on/after 10/01/2022; prior to 10/01/2022 file with 81479
0411U — IDgenetix: use on/after 10/01/2023; prior to 10/01/2023 file with 81479
81479 — Unlisted molecular pathology procedure for other panels or prior dates of service

Denial Risk

Laboratory authorization restriction

Laboratories are not permitted to obtain prior authorization or participate in the authorization process on behalf of the ordering physician. If a laboratory provides a service that has not been authorized, the service may be denied and the financial liability may be assigned to the participating laboratory rather than to the member.

Background and Evidence

Pharmacogenomic panels analyze genetic variants that can affect drug metabolism, treatment response, and risk of adverse events to inform medication selection and dosing. Clinical utility requires evidence that management guided by testing improves net health outcomes compared with standard care; randomized controlled trials or other intervention studies demonstrating such outcome benefits are preferred. Many commercially available panels exist, but available trials and observational evidence have limitations and, for several panels, are insufficient to establish improved clinical outcomes.

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Study / Evidence	Summary
GUIDED trial (GeneSight)	Reported improvement in response (26% vs 20%, p=0.01) and remission (15% vs 10%, p=0.007) at 8 weeks in the GeneSight arm versus standard care, but substantial missing data and other limitations preclude definitive conclusions.
Neuropharmagen RCTs	Mixed results: one single‑blinded RCT reported improved response but not remission with methodological limitations (high dropout, LOCF imputation, no trial registration); a second RCT showed no significant differences. Overall trials have major design and conduct limitations and evidence is insufficient.

Definitions: Laboratory-developed test (LDT) — clinical laboratory tests developed and validated in-house that must meet Clinical Laboratory Improvement Amendments (CLIA) standards for high-complexity testing; these LDTs are commonly how pharmacogenomic panels are offered.

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Medicare Determinations

Name	Type	Number	Effective Date	Notes
MolDX Pharmacogenomics Testing (referenced)	LCD			Listed as a referenced MolDX local coverage determination in the policy references.
IDgenetix (CPT 0411U)	CPT code	0411U	New code effective 10/01/2023	For dates of service prior to 10/01/2023, use CPT 81479 (Unlisted molecular pathology procedure). Covered for Medicare Advantage and Commercial as indicated in policy coding section.
GeneSight Psychotropic (CPT 0345U)	CPT code	0345U	Code effective 10/01/2022	For dates of service prior to 10/01/2022, use CPT 81479. Coverage: Medicare Advantage — may be medically necessary when criteria met; Commercial — listed as not medically necessary.
Unlisted molecular pathology procedure	CPT code	81479		Used for panels without specific CPT codes or for dates of service prior to effective dates of specific CPT codes; prior authorization required when 81479 is used.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Genetic Testing for Diagnosis and Management of Mental Health Conditions

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateOct 1, 2023

Next Review Date

SourceLink

On This Page

Must meet A or B

A Initial Testing (ALL of the following)
- When medication therapy is being considered (has not already been administered), documentation must include that testing is required to define safe use of the drug in the individual
- Medication is medically necessary, appropriate and approved for use with specific diagnosis
- Medication is known to have a gene(s)-drug interaction that has been demonstrated to be clinically actionable
- Test results are necessary for safe administration or dosing of medication
- Selection of medication must be derived from clinical factors/necessity rather than from testing
B Additional Testing
- Documented medical necessity for additional testing
- ANY of the following
  - More than one gene is reasonable and necessary for the safe use of the drug being considered or in use
  - More than one drug is in consideration or use that is associated with a gene-drug interaction

OpenPayer

Medical Coverage Policy Genetic Testing for Diagnosis and Management of Mental Health Conditions

Coverage Summary

Medical Necessity Criteria

Not Covered / Not Medically Necessary Tests

Coding

Provider Actions

Background and Evidence

Medicare Determinations

Revision History