Continuing the Trump administration’s efforts to lower drug prices and reduce patient out-of-pocket costs, on February 6,2019, the U.S. Department of Health and Human Services Office of Inspector General (“HHS”) released a much anticipated proposed rule setting forth significant changes to the regulatory discount safe harbor under the federal Anti-Kickback Statute (“AKS”), with the potential to substantially disrupt existing arrangements between drug manufacturers, pharmacy benefit managers1 (“PBMs”) and health plans.
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