In a letter to the Food and Drug Administration (FDA), the CME Coalition applauds the agency’s recognition—as noted in its September 2014 report—that continuing medical education (CME) plays an essential role in improving knowledge of drug-related risks. The Coalition highlights their support for the FDA’s intention to evaluate the feasibility of drug-specific REMS CME training. As detailed in the letter, “preliminary research suggests that REMS-related CME can reach substantial numbers of providers who do not otherwise choose to engage with standard REMS communication, such as a Dear Healthcare Provider letter… As noted in the FDA’s September 2014 report, REMS CME activities could be developed both for approved drugs as well as for pending drugs prior to FDA approval, with the REMS CME published or presented upon drug launch.” The Coalition goes on to suggest that plans to develop CME should include provision of resources to measure and evaluate the effect of the activities, and expresses a willingness to work with the FDA regarding priorities for REMS education, resolution of priorities and barriers, and best practices for adult learning in the CME environment as it relates to REMS.
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.”