We evaluated insurance coverage for pharmacogenomic (PGx) testing for psychotropic drugs among 36 coverage plans from public and private payers (N=24). We assessed the sources of evidence cited, identified biomarkers, and referenced current procedural terminology (CPT) codes within policy documents. Half of the coverage plans in the sample (50%) provided no coverage for PGx testing for psychotropic drugs, deeming pharmacogenomic (PGx) testing "investigational in all circumstances" due to limited regulatory oversight and insufficient research supporting its clinical utility. The other half of plans in the sample (50%) offered conditional coverage with provisions related to specific patient criteria, a limited set of PGx tests or panels (e.g., GeneSight® Psychotropic panel), or both. Overall, public and private payers show similar progress in offering conditional PGx testing coverage. Clinical Pharmacogenetics Implementation Consortium (CPIC), Center for Medicare and Medicaid (CMS), and Food and Drug Administration (FDA) were commonly cited as evidence sources across coverage plans and the broader PGx landscape within the field of psychiatry. We identified (N= 63) biomarkers across the total sample of coverage plans, but only three had FDA labeling guidelines for relevant psychiatric medications, with CYPD26 being the most cited biomarker, and holding the largest number of associated medication labels (N=37). Among CPT codes associated with specific biomarkers within policies (N= 42), only one CPT code (81599) had no associated biomarkers. Collectively, findings underscore the need for more evidence-based research to support broader PGx coverage and access to PGx tests for psychiatric conditions.
Authors: Sandra Yankah, Duke Margolis Center for Health Policy; Rachele Hendricks-Sturrup, Duke Margolis Center for Health Policy; Maryam Nafie, Duke Margolis Center for Health Policy; Christine Lu, The University of Sydney
