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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.
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 |
|
| 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.
| Links |
- Link to Provider Resource Center for the Medical Policy Update
05/2018, REMINDER: Molecular and Genomic Testing
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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.
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Room 509F, HHH Building
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