In response to an overwhelming outpouring of stakeholder comments, CMS published a Final Rule (pg. 595-596) redefining its Open Payment reporting rules to specifically exclude the vast majority of CME payments, including speaker-related payments and tuition support for attendees, so long as they follow CME guidelines and are, therefore, not directed by a commercial supporter. Although CMS deleted the section of a previous rule that defined a limited CME reporting exclusion for CME payments for certain accredited programs, the new rule sets reasonable criteria for determining which CME-related payments need not be reported.
While CMS announced that the section of last year’s Open Payments rule that created a special CME exemption was eliminated, the agency provided redefined and pre-existing reporting rules that specifically exclude CME payments -- including speaker-related payments and tuition support for attendees -- so long as they are not directed by a commercial supporter and otherwise do not meet the definition of an indirect payment under §403.904(i)(1).
Specifically, CMS clarifies that where "an applicable manufacturer or applicable GPO provides funding to support a continuing education event [and] does not require, instruct, direct, or otherwise cause the continuing education event provider to provide the payment … to a covered recipient, the [commercial supporter] is not required to report the payment.” (page 595) Importantly, CMS specifically declares under the Final Rule that such indirect CME-supporting transfers of value are not reportable, even if the commercial supporter subsequently discovers the identity of the covered recipient “because the payment or other transfer of value did not meet the definition of an indirect payment.”
Furthermore, CMS addressed another important concern of CMS stakeholders by making it clear that physician attendees of CME programs need not be reported to Open Payments for the value of their educational experience, so long as the commercial supporter does not "instruct, direct, or otherwise cause the subsidized tuition fee for a continuing education event to go to a specific physician attendee.” (Final Rule at pages 595-596). The CME Coalition looks forward to working with CMS to assist the agency in drafting sub-regulatory guidance regarding tuition fees provided to physician attendees, which the agency expects not to be reported.
Specifically, CMS clarifies that where "an applicable manufacturer or applicable GPO provides funding to support a continuing education event [and] does not require, instruct, direct, or otherwise cause the continuing education event provider to provide the payment … to a covered recipient, the [commercial supporter] is not required to report the payment.” (page 595) Importantly, CMS specifically declares under the Final Rule that such indirect CME-supporting transfers of value are not reportable, even if the commercial supporter subsequently discovers the identity of the covered recipient “because the payment or other transfer of value did not meet the definition of an indirect payment.”
Furthermore, CMS addressed another important concern of CMS stakeholders by making it clear that physician attendees of CME programs need not be reported to Open Payments for the value of their educational experience, so long as the commercial supporter does not "instruct, direct, or otherwise cause the subsidized tuition fee for a continuing education event to go to a specific physician attendee.” (Final Rule at pages 595-596). The CME Coalition looks forward to working with CMS to assist the agency in drafting sub-regulatory guidance regarding tuition fees provided to physician attendees, which the agency expects not to be reported.
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