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OIG: Continuing Education Programs Have Independent Value Under AKS

In the wake of the global pandemic, which forced manufacturers, trade organizations, and all other players in the health care industry to rethink how to provide medical education and communication on new product offerings to...more

The AKS "Means What It Says" — But Some Manufacturers and Patients Are Still Between a Rock and a Hard Place on Copay Assistance

In a highly watched case relating to the ability of pharmaceutical manufacturers to support patient copay assistance, the Southern District of New York recently denied Pfizer’s request for a declaratory judgment that two...more

Revised PhRMA Code Responds to OIG Special Fraud Alert on Speaker Programs

Pharmaceutical Research and Manufacturers of America (PhRMA) recently announced revisions to its voluntary “Code on Interactions with Health Care Professionals” (HCPs), which will take effect January 1, 2022. These revisions...more

Anti-Kickback Statute Enforcement Year in Review and Outlook for 2021

I. Introduction - While 2020 was a year like no other in many ways, the challenges posed by the global COVID-19 pandemic do not appear to have stalled the Department of Justice’s (DOJ) health care fraud enforcement...more

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