Proposed Revisions To The Anti-Kickback Regulatory Discount Safe Harbor: What Does This Mean For The Drug Industry And For Your Drug Prices In 2020?

Gray Reed
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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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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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