As highlighted in full below, Inside Health Policy writes about the CME Coalition's concerns for the proposed change to the Sunshine Act's reporting requirements for accredited CME activities. As noted in the article, which extensively cites the Coalition's policy brief, the Coalition has expressed that CMS has wrongly reopened a rule that it had already finalized. The article cites a CME industry stakeholder describing concerns that "lawyers for manufacturers will advise them not to sponsor CME events with indirect payments because they will inevitably find out who speakers and presenters are as soon as the agenda of the event is made public, thereby under the letter of the provision making those payments reportable."
The CME Coalition is worried that CMS' plan to drop the continuing medical education exclusion from the Sunshine Act will have a negative impact on both speakers and attendees at CME events, despite CMS' assurances that doing away with the CME exclusion will not require reporting of indirect payments from drug and device manufacturers to CME lectures and conferences.
“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," a post on the CME Coalition's website concerning the CMS proposal reads.
In its July 3 proposed physician payment rule, CMS says it wants to get rid of the CME exclusion in the Sunshine Act because it is redundant with another provision of the law. The proposed rule states that indirect payments from drug and device manufacturers to sponsor or underwrite CME events where the manufacturers have no control of the subject matter or speakers at the event would not have to be reported.
The provision that CMS says will take care of keeping indirect payments for CME events from having to be reported once the CME exclusion is gone states that manufacturers must be "unaware" of the lecturers' identities for essentially up to a year and a half after the indirect payment has been made.
On its website post the CME Coalition, which represents a variety of CME stakeholders, reiterates a concernrelayed to Inside Health Policy by an industry lawyer that it is nearly impossible for a manufacturer to be "unaware" or not know the names of doctors who gave CME lectures for up to 18 months after the indirect payment was made.
An official with a leading CME stakeholders group suggests the worry is that lawyers for manufacturers will advise them not to sponsor CME events with indirect payments because they will inevitably find out who speakers and presenters are as soon as the agenda of the event is made public, thereby under the letter of the provision making those payments reportable.
The CME Coalition states on its website post it worries that if CMS does away with the CME exclusion, educational materials given to attendees at lectures and events may also become reportable.
The industry official points out that this reporting exclusion is detailed specifically in the CME exclusion and does not seem to be accounted for in the second Sunshine Act provision CMS says will now cover indirect payments if the CME exclusion is dropped. In proposing to do away with the CME exclusion as part of the physician pay rule, CMS does not make any mention of attendees and the materials they receive at CME events.
"I can't imagine CMS meant to get rid of that reporting exclusion, but they don't address it," the industry official says. "There is a big concern that physicians will be less inclined to attend CME events if their names and the educational materials they receive will be reported on a public website, as if there's something wrong with (physicians getting educational materials relevant to their continuing education)."
The CME Coalition also worries that the rule change by CMS will open up the reporting exclusion to non-accredited CME education, which would include marketing presentations by drug and device manufacturers.
CMS says in its proposal to do away with the CMS exclusion that the way the exclusion is written makes it seem as if CMS is specifically endorsing five CME accrediting organizations at the exclusion of others.
The CME industry official says that roughly 26 percent of funding for CME events comes from indirect payments from manufacturers. The official adds that many manufacturers may stop investing in CME if the CME stakeholders are worried about of the unintended consequences of doing away with the CME Sunshine Act exclusion.
"Some drug companies may come to view CME as not worth it and start pulling out," the official says. "CME is an important building block in providers education, and the money has to come from somewhere."
The industry official says CME stakeholders will bring these concerns to CMS during the public comment period for the proposed rule.