Genetic Testing for Diagnosis and Management of Mental Health Conditions

POLICY NUMBER

A.2.04.110

DESCRIPTION

Individual genes have been shown to be associated with the risk of psychiatric disorders and specific aspects of psychiatric drug treatment such as drug metabolism, treatment response, and risk of adverse events. Commercially available testing panels include several of these genes and are intended to aid in the diagnosis and management of mental health disorders.

This policy assesses whether genetic testing for the diagnosis and management of mental health conditions is clinically useful. To make a clinical management decision that improves the net health outcome, the balance of benefits and harms must be better when the test is used to manage the condition than when another test or no test is used. The net health outcome can be improved if individuals receive correct therapy, or more effective therapy, or avoid unnecessary therapy, or avoid unnecessary testing.

The primary goal of pharmacogenomic testing and personalized medicine is to achieve better clinical outcomes compared to managing the condition with the standard of care. Drug response varies greatly between individuals, and genetic factors are known to play a role. However, in most cases, the genetic variation only explains a modest portion of the variance in the individual response because clinical outcomes are also affected by a wide variety of factors, including alternate pathways of metabolism and patient- and disease-related factors that may affect absorption, distribution, and elimination of the drug.

Therefore, assessment of clinical utility of a pharmacogenetic test cannot be made by a chain of evidence from clinical validity data alone. In such cases, evidence evaluation requires studies that directly demonstrate that the use of the pharmacogenomic test to make management decisions alters clinical outcomes; it is not sufficient to demonstrate that the test predicts a disorder or a phenotype. Direct evidence of clinical utility is provided by studies that compare health outcomes for patients managed with or without the test. Because these are intervention studies, the preferred evidence is from randomized controlled trials.

Clinical laboratories may develop and validate tests in-house and market them as a laboratory service; laboratory-developed tests (LDTs) must meet the general regulatory standards of the Clinical Laboratory Improvement Amendments (CLIA). The tests discussed in this section are available under the auspices of the CLIA. Laboratories that offer LDTs must be licensed by the CLIA for high-complexity testing. To date, the U.S. Food and Drug Administration has chosen not to require any regulatory review of this test.

Examples of commercially available panels include the following:

• Genecept™ Assay (Genomind);

• STA²R test (SureGene Test for Antipsychotic and Antidepressant Response; Clinical Reference Laboratory). Specific variants included in the panel were not easily identified from the manufacturer's website.

• GeneSight® Psychotropic panel (Assurex Health);

• Mental Health DNA Insight™ panel (Pathway Genomics);

• IDgenetix-branded tests (AltheaDx).

Also, many labs offer genetic testing for individual genes, including MTFHR (GeneSight Rx and other laboratories), CYP450 variants, and SULT4A1.

AltheaDx offers a number of IDgenetix-branded tests, which include several panels focusing on variants that affect medication pharmacokinetics for a variety of disorders, including psychiatric disorders.

POLICY

Genetic testing for diagnosis and management of mental health disorders is considered investigational in all situations, including but not limited to the following:

• To confirm a diagnosis of a mental health disorder in an individual with symptoms.

• To predict future risk of a mental health disorder in an asymptomatic individual.

• To inform the selection or dose of medications used to treat mental health disorders, including but not limited to the following medications:

  • selective serotonin reuptake inhibitors;

  • selective norepinephrine reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors;

  • tricyclic antidepressants;

  • antipsychotic drugs.

Genetic testing panels for mental health disorders, including but not limited to the Genecept Assay, STA²R test, the GeneSight Psychotropic panel, the Proove Opioid Risk assay, and the Mental Health DNA Insight panel, are considered investigational for all indications.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

04/01/2014: Approved by Medical Policy Advisory Committee.

09/04/2014: Policy title changed from "Genecept Assay" to "Genetic Testing for Mental Health Conditions." Policy description revised. Policy statement revised to remove the following investigational statement: The Genecept™ panel assay is considered investigational for all indications. Added the following investigational statements: 1) Genetic testing for mutations associated with mental health disorders is considered investigational in all situations. 2) Genetic testing panels for mental health disorders, including but not limited to the Genecept Assay, STA²R test, the GeneSight Psychotropic panel, and the Proove Narcotic Risk assay, are considered investigational for all indications.

07/30/2015: Code Reference section updated for ICD-10.

06/09/2016: Policy number A.2.04.110 added. Investigative definition updated in Policy Guidelines section.

07/18/2016: Policy description updated to change "psychiatric disorders" to "mental health disorders" and to add table of genes included in genetic panels for mental health disorders. First policy statement updated to add investigational indications; intent unchanged. Second investigational statement updated to change "Narcotic" to "Opioid" and to add the Mental Health DNA Insight panel as investigational. Policy Guidelines updated to add genetic counseling information.

07/18/2017: Policy description updated regarding genetic panels and included genes. Policy statement updated to change "mutations" to "variants." Policy Guidelines updated regarding standard terminology for variant classification.

07/31/2018: Policy title changed from "Genetic Testing for Mental Health Conditions" to "Genetic Testing for Diagnosis and Management of Mental Health Conditions." Policy description updated regarding pharmacogenomic testing and genes relevant to the diagnosis and management of mental health disorders. First investigational statement revised to state that genetic testing for diagnosis and management of mental health disorders is considered investigational in all situations. Investigational statement updated to specify medications used to treat mental health disorders. Policy Guidelines updated regarding genetic counseling.

08/05/2019: Policy description updated regarding genetic tests. Policy statements unchanged.

06/23/2020: Code Reference section updated to add new CPT codes 0173U and 0175U, effective 07/01/2020.

09/03/2020: Policy description updated regarding pharmacogenomics testing. Policy statements unchanged. Policy Guidelines updated to remove genetics nomenclature.

08/30/2021: Policy description updated regarding genes associated with psychiatric disorders and treatment. Removed list of genes and commercially available tests. Policy statements unchanged.

12/16/2021: Code Reference section updated to add new CPT codes 0291U, 0292U, and 0293U, effective 01/01/2022.

08/09/2022: Policy description updated to change "patients" to "individuals." Policy statements unchanged.

09/13/2022: Code Reference section updated to add new CPT code 0345U. Effective 10/01/2022.

07/01/2023: Code Reference section updated to add new CPT code 0392U.

08/08/2023: Policy reviewed; no changes.

09/25/2023: Code Reference section updated to add new CPT codes 0411U and 0419U, effective 10/01/2023.

12/21/2023: Code Reference section updated to add new 2024 CPT codes 0423U and 0437U, effective 01/01/2024.

08/12/2024: Policy reviewed; no changes.

10/01/2024: Code Reference section updated to add new CPT codes 0476U and 0477U.

09/09/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross and Blue Shield Association Policy # 2.04.110

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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