One area that has not received much attention is the CME commercial support or grant request process. In the final rule, CMS references an “unrestricted” grant or donation to a physician organization when explaining when indirect payments are reportable. The CME Coalition asked CMS to clarify whether the “unrestricted” example would be applicable to CME providers or physician organizations providing Sunshine-exempt CME programs. While some CME grants are “restricted” because they target a particular disease or class of treatments, CMS focuses on how the payment is being made through a third party to a physician, not to what topic (e.g., diabetes, cancer) the payment is directed.

An accredited or certified CME provider’s grant request is unrestricted in terms of whom the CME provider will choose for speakers, or invite to attend, because the ACCME SCS prohibit applicable manufacturers from choosing, recommending or providing a list of speakers or attendees. In fact, the CME provider’s involvement is “specifically to maintain the anonymity” of the speakers and the sponsor until the CME provider has been awarded commercial support, so it appears that CME providers should be able to continue commercial support grant requests consistent with ACCME SCS. Teaching hospitals that have CME departments, and other CME providers that employ physicians on staff and receive commercial support directly from applicable manufacturers, have several key areas to consider.

While CME providers may employ physicians who are normally subject to the Sunshine Act reporting, physician employees likely are not subject to the reporting requirements of the final rule with respect to their administration of CME programs. Since they are considered faculty, they receive value (salary) directly from their employer-provider and not from the provider’s client-manufacturers. Accredited CME providers and the CMS conditions prohibit an applicable manufacturer from directing the disposition of grant funds used for an accredited CME program. Accordingly, CME providers must ensure that CME grants do not direct or otherwise earmark grant funds for compensation to a CME provider’s physician employee.

In comments submitted to CMS, the CME Coalition noted that there are at least 11 other accrediting or certifying bodies and several international entities that use physicians as speakers or faculty and have either formally adopted the ACCME Standards for Commercial Support or substantially identical standards. In other words, CME stakeholders asked CMS whether it would recognize other accrediting groups that “meet the accreditation or certification requirements and standards” of one of the five entities enumerated by CMS.

However, CMS recently clarified in an FAQ that this initial list of accrediting bodies “is exhaustive.” CMS did maintain that it will “consider modifications … in possible future rulemaking,” leaving open the chance for other certification or accreditation bodies to be recognized for the exemption. Nevertheless, payments provided as compensation to speakers at CME events run by CME providers that are not accredited or certified by one of the enumerated bodies are reportable, likely as “compensation for services other than consulting.” Manufacturers could also report such payments as “honorarium,” “grant,” or “education,” depending on the nature of the arrangement.

Also reportable are payments provided to speakers, faculty, and physician attendees for travel, lodging, and meals at CME programs that are not accredited by one of the five enumerated bodies. Educational value and materials provided to physician-attendees, such as a journal reprint, would also be reportable for those not accredited by the five bodies. CMS recommended in a separate FAQ that “[t]he value of a journal reprint should reflect the cost that an applicable manufacturer … paid to acquire the reprint from the publisher or other distributor.”