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Precision medicine holds the promise of a more targeted approach to diagnosing and treating illnesses based on individual patient information. The Precision Medicine Initiative and the "Cancer Moonshot" made precision medicine a buzzword in the latter years of the Obama Administration. However, significant reimbursement and regulatory policy challenges exist, to be addressed by a new administration committed to eliminating regulations and once again transforming the healthcare system. This session will explore the public policy issues being considered by Congress, FDA and CMS, such as evolving evidentiary standards for clinical utility, the implementation of market based pricing under the 2014 Protecting Access to Medicare Act and the regulatory approval pathway, including complimentary versus companion diagnostics.

Session ID: 22122

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