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FDA Proposes to Clarify and Formalize the De Novo Classification Process for Medical Devices

USA - January 16 2019 On December 7, 2018, the U.S. Food and Drug Administration (“FDA”) published a proposed rule (“Proposed Rule”) that, if finalized, would clarify the...


The SUPPORT for Patients and Communities Act: Part 1: New Federal Anti-Kickback Law - Eliminating Kickbacks in Recovery Act of 2018

USA - December 10 2018 President Trump recently signed sweeping bipartisan legislation to combat the opioid epidemic. TheSubstance Use-Disorder Prevention that Promotes...

Charles C. Dunham, IV, Robert E. Wanerman, Richard W. Westling.


Top Five Takeaways from MedPAC’s Meeting on Medicare Issues and Policy Developments - November 2018

USA - November 20 2018 The Medicare Payment Advisory Commission (“MedPAC”) held its monthly public meetings in Washington, D.C., on November 1-2, 2018. The purpose of this...

Brian Hedgeman.


The SUPPORT for Patients and Communities Act: Expanding Medicare Coverage of Telehealth Services to Combat the Opioid Crisis

USA - November 5 2018 The SUPPORT for Patients and Communities Act (“the Act” or “the SUPPORT Act”), signed into law by President Trump on October 24, 2018, is intended to...

Charles C. Dunham, IV.


The SUPPORT for Patients and Communities Act: President Trump Signs Sweeping Opioid Law

USA - November 2 2018 On October 24, 2018, President Trump signed sweeping bipartisan legislation to combat the opioid epidemic. The Substance Use-Disorder Prevention that...

Lynn Shapiro Snyder, Lauren A. Farruggia, Brian Hedgeman, Audrey Davis, James A. Boiani.