On July 3, presumably in response to concerns that were put forward by the CME Coalition and others about the need to expand the list of accrediting bodies that counted towards determining CME Sunshine exemption, CMS proposed eliminating the section of the current Final Rule that requires events to be accredited by one of five enumerated accredited bodies in order to be “sunshine exempt” (the Accreditation Council for Continuing Medical Education ("ACCME"), the American Academy of Family Physicians ("AAFP"), the American Dental Association's Continuing Education Recognition Program ("ADA CERP"), the American Medical Association ("AMA"), or the American Osteopathic Association ("AOA").
Although CMS has suggested that its sole intent is to expand the range of educational events where the value of the honoraria, travel expenses or food may be exempt from reporting for the purpose of speakers, we are concerned that the way they did it could have three devastating outcomes unless remedied:
- Speakers - Because CMS only states that indirect payments to speakers at continuing education events will be exempt from reporting in its proposed preamble, and not in the actual rule, it is considered very unreliable from a legal standpoint and it could easily be instead interpreted as a reportable “indirect payment.” Recall that under the Final Rule as written, indirect payments must be reported to Open Payments if the applicable manufacturer becomes aware of the identity of the recipient of the payment within 18 months of the payment. Thus, because CME presenters are always publicly listed, as a practical matter these payments will all have to be reported.
- Attendees - Because current CMS guidance that CME event attendees are only exempt from reporting for the educational value (or ancillary items) provided at accredited CME events per Section §403.904(g), the entire status of attendees is now jeopardized as a result of the proposal to eliminate this provision, and they may have to be consider (and reported) as indirect payments. CMS needs to clarify whether this reporting exemption still exists for attendees, and if so, what kind of events qualify.
- The Future of Accredited CME – In essence, CMS is proposing to blur any distinction between their treatment of accredited CME and other educational programming for the purpose of treatment under the Sunshine Act, which is a very damaging precedent from the perspective of both doctors and patients. Accredited CME is different. It is the Gold Standard of continuing medical education and has been relied upon often by the federal government in the pursuit of public health objectives. CMS should maintain these important reporting exemptions only for physicians who participate in bona fide accredited CME.