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Palmetto Finalizes Local Coverage Determination for Assurex Mental Health PGx Test

NEW YORK (GenomeWeb) – Medicare contractor Palmetto GBA has finalized a local coverage determination (LCD) for Assurex Health's GeneSight Psychotropic pharmacogenomic test, in which it has agreed to reimburse for the test for certain beneficiaries suffering from depression.

According to the final LCD, the test is covered under Medicare when it is ordered by licensed psychiatrists for major depressive disorder patients who have failed to respond to at least one neuropsychiatric drug and for whom doctors are considering switching medications. The final decision follows a draft LCD issued by Palmetto over the summer that laid out similar coverage stipulations.

GeneSight Psychotropic analyzes 50 alleles from six genes that have been shown in studies to affect a person's response to antidepressant and antipsychotic treatments. Included on the panel are pharmacokinetic genes from the CYP450 family and pharmacodynamic genes implicated in the serotonin system.

The test has a list price of several thousand dollars. However, for Medicare Part B patients that fit the LCD criteria, there will be no out-of-pocket costs, Assurex highlighted in a statement announcing the final LCD.

"Prior to GeneSight, no psychiatric pharmacogenomic test has achieved a favorable coverage decision from Medicare," the company added in the statement.

Medicare provides health insurance to 52 million people aged 65 years or older. Assurex estimated that 15 percent of the Medicare population and nearly half of those in nursing homes have depression and may be eligible for covered testing.