An article in Inside Health Policy helped to clarify stakeholder concerns about Sunshine Act reporting for continuing medical education events (CME). The article quotes the CME Coalition's response to the rule, noting that "as a practical matter, because the standards for commercial support inherent in most accredited CME already prohibit commercial supporters from paying speakers directly, suggesting speakers (e.g., providing a list), or otherwise controlling the nature or content of the educational program, there will not be any necessity to report CME payments under the Sunshine Act for most accredited CME programs. Therefore the CME Coalition applauds CMS for clarifying these important rules in such a manner."
CMS moved forward with plans to drop the continuing medical education (CME) exemption from the Open Payments Program (sunshine law) and clarified in the 2015 final physicians pay rule that, if manufacturers and GPOs that fund CME events don't have any say over who speaks or how the events use the money, then the payments don't have to be reported because they fall outside the definition of indirect payment.
The vast majority of stakeholders had worried when CMS first proposed axing the CME exclusion from the sunshine law that it would mean money manufacturers provide for CME events would have to be reported as indirect payments. Now the CME Coalition, which opposed CMS' proposal to drop the CME exclusion, is applauding the agency's clarification.
Stakeholder worries stemmed from CMS saying in the proposed rule that it was getting rid of the CME exclusion because it was redundant with another provision of the Sunshine Law which excludes indirect payments or transfers to medical professionals providing CME lectures as long as manufacturers are "unaware" of the lecturers' identities for up to a year and a half after the indirect payment has been made.
CME providers argued -- as CMS notes in the final rule -- that given the nature of CME it's impossible for drug and device companies to remain ignorant of speakers' identities that are publicly available on conference agendas and elsewhere, such as trade press accounts of speaker presentations.
CMS clarified in the final rule that as long as a manufacturer or GPO gives "full discretion" to the CME provider as to how to spend the money and has no input on who speakers and presenters are then it doesn't matter if a manufacturer or GPO finds out who spoke at an event, because those payments do not qualify as an indirect payment.
"(I)f an applicable manufacturer or applicable GPO provides funding to support a continuing education event but does not require, instruct, direct, or otherwise cause the continuing education event provider to provide the payment or other transfer or value in whole or in part to a covered recipient, the applicable manufacturer or applicable GPO is not required to report the payment or other transfer of value. The payment is not reportable regardless if the applicable manufacturer or applicable GPO learns the identity of the covered recipient during the reporting year or by the end of the second quarter of the following reporting year because the payment or other transfer of value did not meet the definition of an indirect payment," CMS says in the final rule.
CMS says this type of sponsorship by manufacturers of CME events is similar to a manufacturer giving an "unrestricted donation" -- meaning the money has no strings attached -- to a physician professional organization, that then decides to use the money for grants to physicians. In this case the manufacturer would not be required to report the donation as an indirect payment, because the manufacturer did not direct the organization to use the money for physician grants.
"Therefore, because such payments are not indirect payments, we do not need to create an additional exclusion specific to continuing education indirect payments by modifying the indirect payment exclusion at §403.904(i)(1)," CMS says.
Andrew Rosenberg, senior advisor for the CME Coalition, said since accredited CME providers don't allow manufacturers or GPOs who sponsor or donate to a CME event to dictate how the money can be spent most CME payments won't have to be reported.
"As a practical matter, because the standards for commercial support inherent in most accredited CME already prohibit commercial supporters from paying speakers directly, suggesting speakers (e.g., providing a list), or otherwise controlling the nature or content of the educational program, there will not be any necessity to report CME payments under the Sunshine Act for most accredited CME programs. Therefore the CME Coalition applauds CMS for clarifying these important rules in such a manner," Rosenberg said.
Stakeholders had also worried that if money donated by a manufacturer was used to subsidize fees for attendees at a CME event or to help pay for educational materials then they would have to be reported as indirect payments if the CMS eliminated the specific CME exclusion.
CMS says that these subsidies for attendees will not have to be reported as indirect payments as long as the manufacturer does not not direct the CME provider to subsidize fees for specific attendees. The agency says it will provide sub-regulatory guidance on the issue.