Physician-Owned Device Companies: In Search of Properly Structured Models

Chair of the Healthcare & Life Sciences Team Maria Currier will speak at the American Health Lawyers Association and Food and Drug Law Institute's Drug, Device, Biologics, and Health Law Program on a panel titled "Physician-Owned Device Companies: In Search of Properly Structured Models."

Ms. Currier will discuss the following:

• background on the Implant Device Industry and the emergence and variety of PODS and other models
• industry response and conflicting legal opinions
• the Senate Finance Committee inquiry and letters to OIG and HHS
• the OIG interim guidance
• where are we now?
  • what did the OIG say?
  • what models survive?
  • what are the features and structures that distinguish different models?
  • ensuring that it is “safe” to do business with physician entities – what reps and warranties and internal compliance safeguards are needed?