Recently, the Office of Inspector General (OIG) at the U.S. Department of Health and Human Services (HHS) issued a rare Special Fraud Alert pertaining to medical device and pharmaceutical speaker programs. The OIG defines speaker programs as “company-sponsored events at which a physician or other health care professional makes a speech or presentation to other health care professionals about a drug or device product or a disease state on behalf of the company.” The sponsoring company typically pays the speakers an honorarium.

On November 20, 2020, the Department of Health and Human Services (HHS) published two new final rules aimed towards supporting care coordination and value-based care. As part of the Trump Administration’s “Sprint to Coordinated Care” plan, the HHS Office of Inspector General (OIG) revised the safe harbors under the Anti-Kickback Statute (AKS) and the Centers for Medicare and Medicaid Services (CMS) revitalized the physician self-referral regulations (“Stark Law”). These reforms are designed to primarily reduce the regulatory burden on the healthcare industry while incentivizing coordinated care.