Spotlight on AKS and Stark Law

Part I: Manufacturer Speaker Programs, Sunshine Act Penalties and Off-Label Promotion

September 24, 2021 1:30pm

Galia Porat
Associate General Counsel
Teva Pharmaceuticals

Eric W. Sitarchuk
Morgan, Lewis & Bockius LLP

Robert L. Vogel
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