The pace of technical and scientific advancement for genomics-based technologies has outstripped the ability of the US regulatory bodies to keep abreast of the emerging paradigms, resulting in regulatory pronouncements that often appear dated and payment systems that are misaligned. Over burdensome evidentiary requirements, encroachment of federal regulators into the practice of laboratory medicine, and failure to align public health objectives with pay or valuation sufficient to support professional pathology services and necessary capital investment threaten to stifle continued innovation in genomic-based diagnostic tools. Nevertheless, the US FDA is committed to improving regulatory science and to increased stakeholder participation in policy-making, and serious efforts to address coding and test value are underway.
View Article and Find Full Text PDFHealth Aff (Millwood)
October 2010
The Patient Protection and Affordable Care Act established a new Patient-Centered Outcomes Research Institute to identify and address research priorities for comparative effectiveness research. Among its many responsibilities, the institute has been charged with setting priorities, developing methodological standards, and communicating research results to decision makers. In this paper we consider how the institute can support the different standards for acceptable evidence used by various government agencies, providers, patients, and other decision makers.
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