In response to an overwhelming outpouring of stakeholder comments, CMS published a Final Rule (pg. 595-596) redefining its Open Payment reporting rules to specifically exclude the vast majority of CME payments, including speaker-related payments and tuition support for attendees, so long as they follow CME guidelines and are, therefore, not directed by a commercial supporter. Although CMS deleted the section of a previous rule that defined a limited CME reporting exclusion for CME payments for certain accredited programs, the new rule sets reasonable criteria for determining which CME-related payments need not be reported.
The American Hospital Association’s (AHA) Physician Leadership Forum recently examined the value of CME to hospitals as a strategic resource for physician-hospital alignment. The report, “Continuing Medical Education as a Strategic Resource” provides an assessment of the value of CME, recommends ways to improve value, and identifies case examples of hospitals that are using CME to improve performance and align the delivery system. Specifically, the report recommends greater use of performance-based CME, more streamlined accreditation standards, broader sharing of best practices, increased communication between CME departments and senior leadership, and greater involvement of physician leaders as champions in CME as ways to improve the use of CME as a strategic resource for hospitals.
Reps. Burgess, Schwarts Introduce Bipartisan Bill to Exempt CME Payments and Medical Texts from Sunshine Act
Today, Representatives Michael Burgess (R-TX) and Allyson Schwartz (D-PA) introduced bipartisan legislation (H.R. 5539) to exempt medical textbooks and journals, as well as indirect payments that pharmaceutical and device manufacturers offer to CME providers, from Sunshine Act reporting requirements. The Sunshine Act lists as one of its exclusions "educational materials that directly benefit patients or are intended for patient use," which do not have to be reported. However, CMS has stated that they do not believe medical textbooks and journal articles fall within this educational carve out. CMS stated these items only have "downstream benefits" for patients as compared to "wall models and anatomical models," which are intended to be used with the patient and are excluded from reporting requirements.
In a notable demonstration of bipartisanship, Representatives Michael Burgess (R-TX) and Frank Pallone (D-NJ), Vice Chairman and Ranking Member of the House Energy and Commerce Subcommittee on Health, came together to encourage the Centers for Medicare and Medicaid Services (CMS) to exempt from Sunshine Act reporting requirements payments related to the support of certified continuing medical education (CME). The lawmakers stated that this would “ensure robust physician participation in this important activity without concern for Sunshine Act reporting rules.”
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.