On Monday, December 15, 2014, CMS published guidance regarding pharmaceutical and medical device manufacturers’ obligations under the Open Payments requirements to report payments they provide indirectly to U.S. physicians in association with continuing medical education (CME) events. The guidance addresses manufacturers’ reporting obligations in the wake of CMS’s recent removal of an exemption to the Open Payments reporting requirements that applied to payments provided indirectly to physicians for speaking at certain accredited CME programs.
The agency’s removal of the exemption was one of several revisions to the Open Payments regulatory requirements that the agency published on November 13, 2014. Manufacturers are required to begin tracking payments in accordance with the regulatory revisions (including the removal of the CME exemption) by January 1, 2016, for reports due by March 31, 2017. The agency’s December 15 guidance provides several examples of CME funding arrangements and addresses what will be the reporting implications of each beginning in 2016. Most notably, CMS indicates that, beginning in January 2016, if “an applicable manufacturer provides a payment to an accredited continuing education organization for a continuing education event for physicians . . . [and] does not pay the physician speaker directly, nor . . . select the speaker or provide the continuing education organization with a distinct, identifiable set of individuals to be considered as speakers for the continuing education[, but] . . . is able to determine who the physician speaker was . . .[, then the payment] will be reportable for 2016 data collection.” This guidance, along with other examples, is available here.