Last week, we attended Shining a Light on the Sunshine Act, as part of the Alliance for Continuing Education in Heath Professions’ Annual Conference. The Centers for Medicare and Medicaid Services (CMS) representative, Anita Griner, answered questions regarding the Physician Payment Sunshine Act, and caused a stir among attendees when she seemed to say that state-accredited continuing medical education (CME) providers are not specifically exempted in the Sunshine Act. This interpretation would require manufacturers to report speaker payments for activities from a state-accredited provider. However, not only did Ms. Griner attempt to clarify her statement, but the Act itself is clear that state-accredited activities are exempt.
The Sunshine Act states, in pertinent part:
| Payments or other transfers of value provided as compensation for speaking at a continuing education program are not required to be reported, if: (i) The event at which the covered recipient is speaking meets the accreditation or certification requirements and standards for continuing education of one of the following:
(A) The Accreditation Council for Continuing Medical Education (B) The American Academy of Family Physicians (C) The American Dental Association’s Continuing Education Recognition Program (D) The American Medical Association (E) The American Osteopathic Association … |
The final rule states: “Accredited and certified continuing education that complies with applicable standards of the accrediting and certifying entities generally includes safeguards designed to reduce industry influence, so we believe that…payments or transfers of value made to support accredited and certified continuing medical education should remain in a distinct category from unaccredited or non-certified continuing education.”
It is important to note that the Accreditation Council for Continuing Medical Education (ACCME) does not directly award credit to activities. Rather, for example, accreditation allows providers to award American Medical Association (AMA) Physician’s Recognition Award (PRA) Category 1 Credit to their CME activities. It is at the CME activity level that Sunshine rules will apply.
The rule makes no distinction in exemption status for “accredited” and “certified” CME. If a program has AMA, AAFP, ADA-CERP, or AOA credit (certified) it is treated the same as if it were ACCME (accredited).The distinction is simple: four of the systems use the word “certified,” and the ACCME uses the term “accredited.” Throughout the rule, CMS refers to “accredited and certified” CME in some places and “accredited and/or certified” CME in others.
The rule clearly exempts both.
ACCME certifies state medical societies with the power to accredit organizations to deliver AMA PRA Category 1 credits. Some have argued that, because ACCME doesn’t directly accredit local organizations, they are somehow not exempt. However, they are certified for AMA PRA Category 1 credit. AMA is one of the five bodies listed in the statute: state medical societies should already be following the AMA rules if awarding AMA credit. Therefore their activities are exempted regardless.
Ms. Griner, the CMS representative, was very well-versed in the Sunshine Act’s language. However, it is very difficult to be prepared for on-the-spot application of the law to continuing medical education—especially in the rapid fire question format, where she is listening in through audio-only communication. When Ms. Griner listened to an audience member ask about “state-accredited CME,” it sounded like she was perhaps hearing this phrase for the first time. The audience member did not say the words “ACCME-accredited” or “AMA-certified,” or one of the other five listed organizations that Ms. Griner had become familiar with by reading the Sunshine Act rule.
It is very telling, then, that after Ms. Griner learned the nuance of how state-accredited programs actually come from ACCME-accreditation of the state medical organization itself, she stated: “That sounds like it would be exempted.”
The session ended soon after, and Jacob Coverstone, the moderator, concluded that an FAQ should be submitted to CMS on the topic.
Other Notes from the Conference:
CMS indicated that there would be no formal rulemaking in 2014. The presenter stated that CMS would be willing to open rulemaking once they collected and reviewed data from the first year of the Sunshine Act, but that 2015 would be the first time they would be open to modifications.
The presentation provided a very well-organized and succinct overview of the Sunshine Act, and the slides are available here.
We appreciated the opportunity to attend the event. Mr. Coverstone provided a fluid presentation and got to the heart of a lot of important questions. The state-accreditation issue, however, was blown out of proportion. We believe a simple reading of the rule and familiarity with the “accreditation and/or certification” process provide a clear answer that state-accredited CME activities ARE exempt under the Sunshine Act.