Promoting Access to Payment Pathways for Emerging Molecular Diagnostics - PROJECT SUMMARY / ABSTRACT. In the era of precision medicine, molecular diagnostics (MDx) can deliver unprecedented opportunities for individualized approaches to care and improve clinical outcomes. Yet, the pace of precision medicine discovery has far exceeded the rate of implementation; consequently, MDx implementation across populations, diseases, and clinical settings is uneven, and disparities persist. Disparities stem from complex and multilevel barriers, but research indicates that patient-facing cost barriers are the biggest challenge for emerging MDx, where clinical guidelines are evolving and payer coverage is uneven. For many conditions, prompt MDx results are essential for personalized treatment approaches to improve outcomes, but barriers that prevent or delay payment for MDx testing can result in either mistreatment or delayed treatment. Institution-level interventions that facilitate access to MDx payment pathways and work towards increasing coverage for MDx will improve patient outcomes and guide effective, ethical, and equitable precision medicine implementation. However, developing strategies to increase MDx access requires new approaches to (1) empirically examine payment pathways to MDx access and (2) identify and characterize the range of institutional resources that best promote access to MDx payment pathways. The proposed research achieves this objective by using a case study of circulating tumor DNA (ctDNA) testing for lung cancer patients; the specific aims are: Aim 1: Analyze differences in patient-level factors associated with different payment pathways for MDx. Aim 2: Define institution-level resources associated with promoting access to MDx payment pathways. Aim 3: Identify and prioritize institution-level interventions that are promising candidates to promote equitable access to MDx payment pathways. The project will provide a knowledge base to understand and improve disparities in access to MDx payment and generate timely evidence to guide more equitable PM implementation. The training plan for the project builds on my expertise in conducting interdisciplinary research to identify PM disparities. It expands my range of qualitative (advanced skills in narrative elicitation) and qualitative data (advanced machine learning and natural language processing [NLP] skills to analyze electronic health record [EHR] data) to conduct rigorous mixed methods research. Comprehensive training and mentoring in health services research, health policy, clinical genetics, health disparities, and implementation science will enable me to effectively translate study findings into effective strategies to promote precision medicine access. The skills and knowledge gained from the training will inform my R01 and lay the foundation for developing practices and policies that can have a significant impact on reducing disparities in precision medicine.
