Clinical Integration of Next Generation Sequencing: A Policy Analysis. A. L. McGuire1, D. J. Kaufman2, G. H. Javitt3, P. A. Deverka4, D. Messner4, R. Cook-Deegan5, M. A. Curnutte1, J. Bollinger2, R. Dvoskin2, S. Chandrasekharan6, B. J. Evans7 1) Ctr Med Ethics, Baylor Col Med, Houston, TX; 2) Genetics and Public Policy Center, Johns Hopkins University, Washington DC; 3) Berman Institute of Ethics, Johns Hopkins University, Baltimore MD; 4) Center for Medical Technology Policy, Baltimore, MD; 5) Center for Public Genomics and Sanford School of Public Policy, Duke University, Durham, NC; 6) Center for Public Genomics and Duke Global Health Institute, Duke University, Durham, NC; 7) The University of Houston Law Center, Houston, TX.

   Introduction: Clinical next generation sequencing (NGS) technologies are challenging existing regulatory, reimbursement and intellectual property paradigms. The volume and breadth of data generated, the bioinformatics requirements for clinical interpretation, and the need to accurately interpret and communicate meaningful information to patients present a host of policy challenges for clinical integration and reimbursement of NGS testing. These are not areas that fit easily within existing policy frameworks . Methods: We recruited 60 stakeholders representing policy makers, payers, research funders, researchers, legal scholars, clinicians, industry representatives and patient advocates to participate in a 4-round Delphi process to both identify and prioritize key policy issues. We also conducted semi-structured interviews with 19industry leaders representing these stakeholder groups and performed an extensive literature and case law review. We prepared four white papers that summarize the major regulatory, reimbursement, intellectual property, and data access issues confronting clinical NGS as background material for the Delphi. Results: We will discuss major issues related to four key policy domains, including quality assurance, insurance coverage, intellectual property management, and data access, that must be addressed to ensure high quality clinical NGS. Findings from the Delphi process will be presented to show how individuals within these different groups understand and prioritize the major policy issues that have been identified. Discussion: New approaches will be needed to establish an oversight and incentive system that promotes appropriate, broad access to high-quality sequence data and valid reports while encouraging innovation. We advocate a coordinated policy approach, which first requires a comprehensive understanding of the existing regulatory and legal structures.

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