Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Unspecified bipolar disorder
Treatment: Gencept Assay (Genomind)
The health plan should cover the proposed treatment.

The requested service of Gencept Assay (Genomind) performed; Pharmacogenetic Testing (81225, 81226, 81227, 81291, 81230,81231, and 81479) is consistent with professional standards and the scientific literature regarding the assessment and treatment of patients with the disorder under review. The services provided are in keeping with prevailing standards of medical practice for the condition under treatment in this case; and, the requested services being provided are clinically appropriate, and are backed by credible scientific evidence known to benefit patients with the condition diagnosed, unspecified bipolar disorder. 

In this case, the patient has had treatment failure with several psychotropic medications and treatment failure or tolerability issues with psychotropic medications that does warrant the use of pharmacogenetic testing in order to guide future treatment and minimize the potential for additional treatment failure or adverse drug reactions. Thus, the use of pharmacogenetic testing is clinically appropriate and indicated for this patient in this case scenario. The rationale for genetic testing is to determine potential effectiveness and dosing of medications for the patient's mental health condition, major depressive disorder in association with bipolar disorder, and, for the purpose of managing clinical treatment of the patient's mood disorder with respect to pharmacodynamic and pharmacokinetic properties of various medications including folate synthesis. 

The requested genetic testing in this case scenario does serve to inform treatment to the extent that it is clinically meaningful or useful, especially with regard to the potential for adverse drug reactions that could be life threatening or cause irreparable harm to the patient. There is sufficient scientific evidence with regard to the effectiveness of genetic testing in this case scenario, and with regard to therapeutic decision-making or patient outcomes, as indicated by the scientific literature and guidelines, referenced below. Thus, treatment could not have effectively proceeded without genetic testing, and, genetic testing does significantly serve to inform the clinician in treatment decisions with respect to evidence-based treatment of the patient's psychiatric disorders. Standard treatment is more trials that are less likely to be beneficial with regard to risk for tolerability problems or lack of efficacy due to pharmacokinetic or pharmacodynamic factors. Genetic testing in this case identifies specific medications that are more likely to be impacted by these factors and less likely to be tolerated or efficacious. Thus, it is reasonable and in the patient's best interest to have genetic testing so that treatment going forward will be more likely to be beneficial and that future treatments will be provided with sound medical judgment in keeping with prevailing standards of medical practice. This answer is consistent with the instructions for this NY State mandated review, and with the scientific literature, referenced below.