Today, the CME Coalition submitted comments to the Senate HELP Committee regarding their new legislative initiative to prioritize drug and device discovery and development.  The Senate endeavor is analogous to the ‘21st Century Cures’ initiative being pursued by the House Energy and Commerce Committee, although the Senate has yet to release a legislative discussion draft presenting specific policies for consideration.

As you may recall, the ‘21st Century Cures’ discussion draft released earlier this month included the bill introduced by Reps. Michael Burgess (R-TX) and Peter DeFazio (D-OR) to exempt CME and educational texts from the reporting requirements of the Sunshine Act.  In the Coalition's comments to the Senate, we encourage them to take a similar approach, highlighting the role of CME in educating physicians on the latest innovations in medicine. 

In comments submitted today to House Energy and Commerce Committee Chairman Fred Upton (R-MI), the CME Coalition applauded the Committee’s 21st Century Cures Initiative, and championed the Committee’s efforts to streamline the implementation of new medical treatments.  The CME Coalition understand that unless doctors are given the tools and education they need to implement the newest innovations in medicine, the promise of 21st Century Cures won’t make it to the bedside – and so, we applaud the Committee for including an important provision in their discussion draft (summary here) to ensure that access to continuing medical education (CME) will not be an unintended casualty of unnecessary regulation.

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.