Table 2. . Current and desired states of standardization of pharmacogenomic test ordering and reimbursement.
Process | Current state | Desired state | Ongoing initiatives | Gaps/opportunities |
---|---|---|---|---|
Gene/drug selections | Genes are selected by laboratory doing the test, often structured around reimbursement and clinicians must navigate these tests after determining the gene to interrogate | Must-test genes drive more consistent panel reimbursement and easier ordering process. Disease-specific guidelines provide recommendations of use of genetic test | CPIC – list of actionable genes and corresponding drugs, uses levels of evidence to support clinical utility (https://cpicpgx.org/genes-drugs/) | List updates needed on ongoing basis Effects of WGS/WES on gene selection/reimbursement |
Market awareness: available tests and appropriate use | Clinicians under-aware of the types of pharmacogenomic tests available and the clinical utility of each | Userfriendly and intuitive database to provide available tests by medication class and disease state with clinical recommendations for use | GTR (www.ncbi.nlm.nih.gov/gtr/) provides central location for voluntary submission of genetic test information by providers | GTR relies on voluntary submission and could be more complete Resources should be readily understandable by patients |
Current reimbursement and out of pocket costs (OOP) | No consensus, little reimbursement for testing outside of oncology, and lack of unique CPT codes | Sharp increase in the number of unique CPT codes for expanding number of tests, payer engagement in requirements from laboratories | Approximately 10 new CPT Tier 1 codes available for 2018 Active research and interest among field |
Further understand payer perspectives on pharmacogenomics, especially evidence requirements and decision making processes Develop structures and tools to reuse pharmacogenomic results over time which increases value of testing |
CPT: Current procedural terminology; GTR: Genetic testing registry; WES: Whole exome sequencing; WGS: Whole genome sequencing.