Donna A Messner1, Pei Koay1, Jennifer Al Naber1, Robert Cook-Deegan2, Mary Majumder3, Gail Javitt4, Rachel Dvoskin4, Juli Bollinger4, Margaret Curnutte3, Amy L McGuire3. 1. Center for Medical Technology Policy, Baltimore, MD 21202, USA. 2. School for the Future of Innovation in Society, and Consortium for Science, Policy & Outcomes, Arizona State University, Tempe, AZ 85281, USA. 3. Center for Medical Ethics & Health Policy, Baylor College of Medicine, Houston, TX 77030, USA. 4. Johns Hopkins Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD 21205, USA.
Abstract
AIM: Identify solutions to the most important policy barriers to the clinical adoption of next-generation sequencing. MATERIALS & METHODS: Four-round modified policy Delphi with a multistakeholder panel of 48 experts. The panel deliberated policy solutions to (previously reported) challenges deemed most important to address. RESULTS: The group advocated using consensus panels to promote consistency in payer policies and to standardize test reporting, and favored making genomic data-sharing a condition of regulatory clearance, certification, or accreditation processes. They were split on the role of US FDA. CONCLUSION: Panelists found common ground on solutions for health plan coverage policy consistency, data-sharing, and standardizing reporting, but were sharply divided on the role of the FDA in mitigating risks to patients.
AIM: Identify solutions to the most important policy barriers to the clinical adoption of next-generation sequencing. MATERIALS & METHODS: Four-round modified policy Delphi with a multistakeholder panel of 48 experts. The panel deliberated policy solutions to (previously reported) challenges deemed most important to address. RESULTS: The group advocated using consensus panels to promote consistency in payer policies and to standardize test reporting, and favored making genomic data-sharing a condition of regulatory clearance, certification, or accreditation processes. They were split on the role of US FDA. CONCLUSION: Panelists found common ground on solutions for health plan coverage policy consistency, data-sharing, and standardizing reporting, but were sharply divided on the role of the FDA in mitigating risks to patients.
Entities:
Keywords:
clinical data reporting; clinical genomics; coverage and reimbursement; intellectual property; next-generation sequencing; personalized medicine; policy; regulation
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