By: Nicodemo (Nico) Fiorentino, Esq., Senior Advisor, Research & Compliance, for G&M Health LLC. and Editorial Board Member, Life Science Compliance Update
Open Payments, commonly known as the Sunshine Act, requires applicable manufacturers to report payments or other transfers of value provided to covered recipients and teaching hospitals. Beginning January 1, 2016, new rules take effect regarding Open Payments and CE/CME sponsored activities and programs, whereby CME exemption provisions are eliminated and replaced with the indirect payments or other transfers of value exclusion. Due to the vagueness of the term, “indirect payments or other transfers of value,” compliance officers and counsel must navigate through the ambiguity created by CMS. In the absence of guidance, a recently decided False Claims Act case provides some protection, though it remains to be seen how robust it will be.