This presentation is intended to generate discussion around the critical legal, practical and ethical issues that physician-owned distributors (PODs) raise. The presentation will dive into recent developments in enforcement against PODs and focus on the practical impact that hospital policies banning business with physician-owned entities have on manufacturers of medical devices. With the recent release of an updated report from the Senate Finance Committee in May 2016, the OIG’s 2013 Special Fraud Alert and studies on PODs, and other policymakers’ concerns, it is crucial for lawyers and compliance professionals in the health care system to have a deep understanding of the issue, including: (1) the ethics and integrity issues posed by PODs and the potential for overutilization and patient safety issues; (2) the legal issues posted by PODs under the Federal health care fraud and abuse laws and the Sunshine Act, including a history of the OIG’s and the Senate Finance Committee’s work on PODs; and (3) how hospital policies limiting business with physician-owned entities in response to these concerns have a disproportionate impact on start-up medical device companies that have some element of physician ownership.
Matt Wetzel, Vice President & Assistant General Counsel - Advanced Medical Technology Association (AdvaMed)
For more information and registration information, please visit the AdvaMed 2016 website.