Grants and CME Program Structuring and Implementation
Government scrutiny of grants by Life Sciences companies remains at an all-time high. Recent settlements reveal that prosecutors continue to treat some grants as a mechanism to promote off-label uses of products. Our counseling in this area focuses on how Life Sciences companies should approach evaluation of grant opportunities and what steps must be taken to ensure compliance with anti-kickback laws, OIG guidances and opinions, and industry codes and standards. For CME programs, we evaluate compliance with the Accreditation Council for Continuing Medical Education Standards for Commercial Support and stay apprised of changes to ACCME standards and guidances. We also counsel on CME guidelines from entities such as PhRMA, AdvaMed and the Office of Inspector General of the Department of Health and Human Services. In addition to developing policies and procedures to guide business personnel, we also prepare contracts with, and conduct audits of, educational providers and research institutions to help minimize legal risks associated with this valuable, but increasingly high risk, endeavor.
