The CME Coalition has submitted public comments to the Centers for Medicare and Medicaid Services (CMS) regarding its proposed change to the Sunshine Act’s current exemption for reporting transfers of value that are affiliated with accredited CME provider organizations to the Open Payments Database. In its submission, the Coalition embraces the preamble of CMS’s proposed rule, that the criteria for determining Sunshine-exempt continuing education should be expanded. However, the Coalition’s analysis of the proposed rule’s actual language suggests that rather than expanding the exemption beyond the originally designated “five accrediting bodies,” the proposal could instead require additional reporting for both speakers and attendees at CME events. The resulting elimination of the CME exemption could be devastating for the practice of CME.
In its place, the Coalition suggests specific language that it believes could meet CMS’s stated objective of designing a policy whereby “if an applicable manufacturer conveys ‘full discretion’ to the continuing education provider, those payments [should be] outside the scope of the rule,” and thus not reportable.