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This includes adaptive trial designs in which treatment can be modified in response to on-therapy biomarker trajectories, longitudinal monitoring enabled by liquid biopsy to noninvasively track the evolution of epigenetic networks [387], and the integration of multi-omics time-series data using artificial intelligence to build predictive models that guide individualized interventions

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We are finalizing our proposal to revise 425.315(a)(4) to make clear CMS' discretion to determine whether to reopen a payment determination applies in the case of fraud or similar fault, as well as to determining whether good cause exists to reopen a payment determination