A new article published in MeetingsNet highlights CMS' recent decision to maintain the exemption for CME-related payments under Open Payments. Rockpointe Corporation President Tom Sullivan, a member of the CME Coalition, noted that CMS proposed to remove the exemption over the summer, but "received more than 900 comments in favor of keeping or expanding" it. And despite the substantial confusion generated over the impact of the Final Rule, he says that the agency actually broadened the amount of CME payments that are excluded from reporting. "CMS’ language is at times confusing," Sullivan explains, "but after reading and re-reading the law, and having countless discussions with attorneys and experts who regularly read rules like this, it is clear that accredited CME remains exempt from Open Payments reporting."
MeetingsNet: The CME Exclusion Remains
On a cold Halloween night while I walked the neighborhood with my children, dressed as Fred Flintstone, the Centers for Medicare and Medicaid Services (CMS) issued its final physician fee schedule for 2015. In that 1,000-plus–page rule was a section describing changes to the reporting requirements for CME-related payments under Open Payments. CME payments were initially exempt under the act if they went toward education programs that were accredited by one of five specific bodies. Such bodies require strict firewalls between manufacturers and the educational activity.
CMS changed course over the July 4th holiday. They proposed to remove the CME exemption, but stated that education grants would be exempt from reporting if manufacturers remained “unaware” of the physician recipient for up to 18 months after an educational event. This interpretation was faulty, however, because manufacturers still may learn of a speaker’s identity in a variety of ways, including through simply reading a CME brochure.
CMS received more than 900 comments in favor of keeping or expanding the CME exemption, and I was interested to see how the agency would respond to the overwhelming feedback. The brief Halloween announcement from CMS—“Deletion of the Continuing Education Exclusion in its entirety”—was not what I had expected and put a damper on trick-or-treating.
Fortunately, this initial announcement was part of a larger rule, which effectively incorporates the CME exemption into other language in Open Payments. In fact, CMS’s accompanying language may have broadened the amount of CME payments that are excluded from reporting.
Instead of considering CME payments under the “indirect payment exclusion” category—which focuses on whether manufacturers were “aware” of the recipients—CMS states that grants for CME programs may not be “indirect payments” at all. If the manufacturer does not “require, instruct, direct, or otherwise cause the [CME] event provider to provide the payment…to a covered recipient,” such payments need not fall into a special indirect payment exclusion because they are not reportable transfers of value in the first place. This is true regardless of whether the manufacturer later learns the identity of the physician faculty.
CMS indicates that manufacturers meet this threshold when they do not (1) select or pay the physician speaker directly, or (2) provide the CME provider with a distinct, identifiable set of physicians to be considered as speakers. Furthermore, CMS notes that fees provided to attendees that have been “generally subsidized at continuing education events by manufacturers are not expected to be reported.”
CMS’s language is at times confusing, but after reading and re-reading the law, and having countless discussions with attorneys and experts who regularly read rules like this, it is clear that accredited CME remains exempt from Open Payments reporting. I now only hope to make it to Thanksgiving dinner without another announcement from CMS.