On Friday, February 1, CMS announced the final regulations to implement the Sunshine Act. Listening to the majority of comments with respect to the CME industry, CMS exempted payments provided as compensation for speaking at a continuing education if certain conditions are met—which are consistent with the ACCME’s accreditation standards and standards for commercial support. The final rule is available here.
The CME Coalition released this press release applauding CMS decision.
We believe that this decision recognizes the adequacy of current protections against bias in CME, and acknowledges CME’s special role in educating physicians and improving patient outcomes. By limiting CME support payments from the reporting rules required of direct physician payments, CMS has made it clear that pharmaceutical companies, medical device manufacturers, and other commercial supporters should not be discouraged from underwriting accredited CME activities.
The Hospitalist, a monthly publication of the Society of Hospital Medicine (SHM), discussed the Sunshine Act's exemption for CME in their May 2013 issue. The article highlights the CME Coalition's efforts to exempt accredited CME from the purview of the Sunshine Act, and cites "three dozen other societies" who lobbied the Centers for Medicaid & Medicare Services (CMS) to amend the proposed rule.
CME Coalition, a Washington, D.C.-based advocacy group, said in a statement the caveat recognizes that CMS “is sending a strong message to commercial supporters: Underwriting accredited continuing education programs for health-care providers is to be applauded, not restricted.”
SHM Public Policy Committee member Joshua Lenchus, DO, RPh, FACP, SFHM, said the initial rule was too restrictive and could have reduced physician participation in important CME activities. “I’m not so sure we needed the Sunshine Act as part of the ACA at all because these same things were in effect from the ACCME and other CME accrediting organizations,” said Dr. Lenchus, a Team Hospitalist member and president of the medical staff at Jackson Health System in Miami. “What this has done is impose additional administrative requirements that now take time away from our seeing patients or doing clinical activity.”
In an article discussing the Final Rule on the Physician Payment Sunshine Act, Medical Marketing & Media characterizes accredited CME as one of the notable 'winners' in the decision on the law. Listening to the majority of comments with respect to the CME industry, CMS exempted payments provided as compensation for speaking at a continuing education if certain conditions are met.
The law exempts reporting on indirect payments to speakers at accredited CME programs made through third parties. CMS said they “agree that industry support for accredited or certified continuing education is a unique relationship. The accrediting and certifying bodies, including ACCME, AOA, AMA, AAFP, and ADA CERP, and the industry standards for commercial support, create important and necessary safeguards prohibiting the involvement of the sponsor in the educational content.”
“The transparency component of the Sunshine Act aims to eliminate potential conflict of interest, and we wholeheartedly support that goal,” says Andy Rosenberg of the CME Coalition, “but the case we were making is that accredited CME is already subjected to very stringent rules, and layering the sunshine act reporting requirements on top of that would be duplicative, unnecessary and ultimately detrimental to the cause of educating physicians. And they agreed.”