Highmark Commercial Medical Policy - Pennsylvania

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Medical Policy: L-234-001
Topic: Pharmacogenomic Testing Panels for Major Depressive Disorder
Section: Laboratory
Effective Date: July 1, 2018
Issue Date: July 2, 2018
Last Reviewed: March 2018

Major depressive disorder (MDD) is a serious mental illness; a major depressive episode can include a number of symptoms, including depressed mood, insomnia or hypersomnia, change in appetite or weight, low energy, poor concentration, and recurrent thoughts of death or suicide, among other symptoms.

Pharmacogenomic testing has been developed to assist clinicians to predict those medications that could yield the most optimal treatment response and/or predict the lowest risk of side effects for an individual with mental health disorders, including MDD.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member’s benefit plan.

Pharmacogenomic testing panels for MDD are considered experimental/investigational (E/I), and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

  • Experimental/investigational (E/I) molecular and genomic (MolGen) tests refer to assays involving chromosomes, DNA, RNA, or gene products that have insufficient data to determine the net health impact, which typically means there is insufficient data to support that a test accurately assesses the outcome of interest (analytical and clinical validity), significantly improves health outcomes (clinical utility), and/or performs better than an existing standard of care medical management option. Such tests are also not generally accepted as standard of care in the evaluation or management of a particular condition.
  • In the case of MolGen testing, FDA clearance is not a reliable standard given the number of laboratory developed tests that currently fall outside of FDA oversight and FDA clearance often does not assess clinical utility.
Procedure Codes
81479, 81599, 84999

Examples of pharmacogenomic panels or individual tests which address treatment of mental health disorders, and are marketed by different labs or manufacturers are as follows:

  • GeneSight Psychotropic
  • GeneceptTM Assay (Genomind)
  • SureGene Test for Antipsychotic and Antidepressant Response (STA2R)
  • Proove Opioid Risk panel (Proove Biosciences)
  • Mental Health DNA InsightTM panel (Pathway Genomics)
  • IDgenetix-branded tests
  • Empowering Personalized Medicine (EPM) Panel
  • GeneSight ADHD, GeneSight Analgesic+
  • Informed PGx ADHD, Informed PGx Depression, Informed PGx Psychotropic
  • YouScript Personalized Prescribing System
  • ABCB1 Genotyping
  • CNSDose
Professional Statements and Societal Positions

  • No specific evidence-based U.S. testing guidelines were identified.

  • The published evidence is currently insufficient to support the use of pharmacogenomic testing to aid in the treatment of the psychiatric disorders, specifically MDD.

  • The manufacturer of GeneSight Psychotropic recently announced results from a randomized, double-blind, controlled trial (NCT02109939). The study is a 24 week RCT that examined 1,200 patients with moderate or severe MDD to assess the impact of the GeneSight test on psychiatric treatment response Patients were randomized to the study group (those receiving the GeneSight test) or the usual treatment group. Assessments were completed at baseline and at 4, 8, 12, and 24 weeks, with patients and raters blinded at the 4 and 8 week weeks. Study results are slated to be presented at the American Psychiatric Association annual meeting in May, 2018. The study has not yet been published in the peer-reviewed scientific literature or indexed in PubMed.

Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Pharmacogenomic is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

The policy position applies to all commercial lines of business

Denial Statements

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.


Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages
If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

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