Spotlight on AKS and Stark Law
Part I: Manufacturer Speaker Programs, Sunshine Act Penalties and Off-Label Promotion
Galia Porat
Associate General Counsel
Teva Pharmaceuticals
Eric W. Sitarchuk
Partner
Morgan, Lewis & Bockius LLP
Robert L. Vogel
Partner
Vogel, Slade & Goldstein, LLP
Hollie K. Foust
Deputy General Counsel
Cardinal Health
- Reviewing the HHS OIG issued special fraud alert on manufacturer-sponsored speaker programs and the implications for industry post-pandemic
- Bolstering compliance controls for selecting speakers and attendees
- Reviewing the manner in which promotional review committees evaluate materials to ensure compliance with DOJ’s evolving approach to enforcing off-label promotion cases
- Appreciating the expansion of the Sunshine Act requiring reporting of payments or transfers of value made
- Preparing for increased interest in parallel settlements between DOJ and CMS under the Sunshine Act’s Open Payments program post-Medtronic