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Life Science Compliance Update
The War on Patient Assistance Programs Takes a New Twist – The Tortured…
In the most recent chapter in the ongoing battle over the priority of patient assistance programs, the Caring Voice Coalition…
The Escobar Hurdle – False Claims, Materiality, and Dismissal
U.S. ex rel. Ruckh v. CMC II LLC et al. (“Ruckh”) was a closely followed False Claims Act case, because a Florida Federal Court…
It’s Not All About the Money – Medtronic’s Infusion Multi-State…
In a closely watched matter culminating years of litigation, Medtronic on December 12, 2017, entered into a $12 Million…
Nicodemo (Nico) Fiorentino Joins Life Science Compliance Update as…
As Life Science Compliance Update enters its fourth year of publication, it is a great pleasure to announce that Nicodemo…
Data Analytics & Detecting Medicare Fraud – A Promising Idea Still…
For analyzing so-called “Big Data” sets, data analytics is an invaluable set of tools and techniques. Now the HHS OIG plans to…
Coming into the Modern Era – CMS Creates Interagency Task Force to…
To control rising costs under Medicare, the Affordable Care Act, and Medicare Access and CHIP Reauthorization Act of 2015…
The Day After Tomorrow – The Drug Pricing Transparency Chorus Grows Louder
Drug pricing transparency, as a concept at least, is here to stay. However, the details of what that means and the new obligations…
The Monster in the Closet – New WHO Report Shines a Light on the…
The issue of substandard and counterfeit medicines has been known for some time. Since it is not often discussed openly, it is…
Privacy Upheaval – Exploring the Impact of the GDPR on Companies Sponsoring…
In May 2018, the new European Union (“EU”) General Data Protection Regulation (“GDPR”) will replace the familiar Data Protection…
Christmas Comes Early – The FCPA Pilot Program Made Permanent
When we first introduced the FCPA Pilot Program in the June 2016 issue, we noted the uncertainties of outcomes for companies who…