July 8, 2018 Bayer Paid Doctors Millions for Questionable Birth Control Device Bayer AG, the pharmaceutical giant responsible for drugs and devices such as Aleve, Aspirin, and Yaz, is facing tens of thousands of lawsuits from women who claim that its new Essure birth control device is dangerous and defective. However, this may not actually…
What Constitutes a “Safe Harbor” in an Anti-Kickback Statute Investigation?
Categories: Anti-Kickback Issues
In a federal investigation under the Anti-Kickback Statute (AKS), a key defense strategy will often be to assert a statutory or regulatory safe harbor. As explained by the U.S. Department of Health & Human Services’ (DHHS) Office of Inspector General (OIG), “[t]he ‘safe harbor’ regulations describe various payment and business practices that, although they potentially…
