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EU in vitro Diagnostic Medical Device Regulation Overview Part 3

European Union - February 7 2017 This publication is the third in a series of three that examines the new European Union (EU) regulations governing Medical Devices and in vitro...

Joachim Heine, Adrian Spooner, Sarah H. Stec, Maren Ebner, Colleen Hermann, Aline Doussin.


OIG Expands Protections Under the Anti-Kickback Safe Harbors and the CMP Exceptions

USA - January 23 2017 On December 7, 2016, the Department of Health and Human Services Office of the Inspector General (OIG) published a final rule (Final Rule) 1 that...

Adam D. Colvin, Robert D. Nauman, Sarah H. Stec, John Bunch, Steve Nash, Kinal M. Patel, Peter A. Pavarini, Patrick D. Cornelius.


Still sending Faxes? Consider content before hitting “send”!

USA - December 30 2016 Last week, the Federal Communications Commission (the Commission) released an Order denying a Petition for Declaratory Ruling by Kohll’s Pharmacy &...


21st Century Cures Act Signed into Law by President Obama

USA - December 14 2016 On December 13, 2016, President Barack Obama signed H.R. 34, the 21st Century Cures Act, into law. This sweeping healthcare law addresses the...

Sarah H. Stec, Leah G. Brownlee, Gregory J. Morrow.


CMS Releases Final Rule Implementing Site Neutral Payment Rule

USA - December 1 2016 Earlier this month, Centers for Medicare and Medicaid Services (CMS) released final rules implementing Section 603 of the Bipartisan Balanced Budget...

Adam D. Colvin, Beth L. Goldstein, Robert D. Nauman, Stephen P. Nash, Peter A. Pavarini, Sven C. Collins.