CMS Seeks to Repeal Sunshine Act Exemption for CME

August 10, 2014
Martin Merritt

An attempt by CMS to repeal a Sunshine Act exemption for payments made to speakers at accredited CME events has physician associations hopping mad.

An attempt by CMS to repeal a Sunshine Act exemption for payments made to speakers at accredited continuing medical education (CME) events has physician associations hopping mad. 

The Sunshine Act requires pharmaceutical and device manufacturers to report direct and indirect payments to physicians.  Under section §403.904(g) of the final rule, payments or transfers of value provided as compensation for speaking at a CME program are not required to be reported, if certain conditions are met.

Namely, the event must be one in which attendees are eligible for CME credit, the manufacturer does not pay the speaker directly, and the manufacturer does not select the speaker. 

On July 3, 2014, CMS proposed to remove the above CME exemption, §403.904(g), "in its entirety." 

It isn’t particularly surprising this news has angered physicians associations.   More surprising, is the fact that anyone was able to locate the proposed change at all, as it was buried on page 242 of a 609 page document.

At the time CMS adopted  §403.904(g), the preamble stated there was no need for reporting of CME  payments to speakers. "Industry support for accredited or certified continuing education is a unique relationship," it stated. CMS initially agreed with the many commenters who stated that accredited or certified continuing education payments to speakers should not be reported because there are safeguards already in place, and they are not direct payments to a covered recipient. 

Healthcare blog Policy and Medicine is now reporting that over 100 medical associations and societies are urging CMS to reconsider CME exemption.

The problem seems to be that §403.904(g) specifically limits the exemption to accredited CME from one of five accrediting organizations:   Accreditation Council for Continuing Medical Education, American Academy of Family Physicians, American Dental Association's Continuing Education Recognition Program, American Medical Association, and the American Osteopathic Association.

CMS has been inundated with requests from other organizations to also be included.  Absent a change, CMS is open to allegations of favoritism. 

The solution, from CMS’ standpoint, is to repeal the exemption altogether, and allow more organizations to certify programs.  The AMA and the co-signing associations are concerned that revoking the existing reporting exclusion for CME would have a “significant chilling effect” on continuing education.

CMS is proposing to implement a new rule, which would replace the §403.904(g) exemption with an “indirect payment” provision. CME grants would then only be exempt where an industry donor is unaware of the physician recipients before and 18 months after the funds are transferred. This is an absurd concept, as the industry could easily learn the identities of speakers by looking at the program materials.

The complete list of societies signing the letter to CMS can be found here.