Last week, The National Association of Medical Education Companies, Inc. (NAMEC) recently submitted its comments regarding Section 6002 of the Patient Protection Affordable Care Act (PPACA)—also known as the Physician Payment Sunshine Act.
NAMEC is the trade organization representing U.S. medical education companies, as well as the clinical faculty, expert contributors, physicians, and allied healthcare professionals who participate in the many thousands of member-developed certified continuing medical education (CME) initiatives. NAMEC’s mission is to promote best practices in CME that meet the many and detailed requirements set forth by accrediting organizations for the conduct of continuing education activities for physicians, as well as other healthcare professionals, with the goal of providing evidence-based education that improves patient care outcomes.
In addition to their overall comments, NAMEC also conducted an online survey of their members in early February. 54 Member Organizations responded. Respondents also provided data and quotes from surveys that they fielded to their faculty. The survey asked questions related to the impact of the proposed Sunshine rules relative to CME providers and reporting of payments to CME faculty and educational materials. The survey indicated that NAMEC members highly concerned about proposed rules:
- Reporting burdens and increases corresponding expenses (> 85% agree or strongly agree)
- Loss of CME funding (76.5% of agree or strongly agree) and resultant loss of CME jobs in their organizations
- Loss of expert faculty participating in CME activities funded by covered manufacturers
- Loss of reputation /credibility of CME providers and of CME
- Reduction in quality of CME and resulting negative impact on healthcare
- Misrepresentation of how CME providers and faculty manage funding from covered manufacturers; inability to meet accrediting organization requirements if accept funding from covered manufacturers (>95% agree or strongly agree)
Faculty are also highly concerned and share many of the concerns of CME providers:
- Misrepresentation of financial relationship between CME faculty and covered manufacturers
- Decreased willingness to participate as CME faculty if proposed rules implemented
- Limitations to participating in CME activities
- Healthcare will be adversely impact if faculty educators reduce or eliminate participation in CME if proposed rules are implemented (78.8% of members)
Almost all members responded that the proposed rules will have significant financial impact on their organizations, with approximately 47% estimating this cost to be at least $50,000 and escalating to >$150,000.
Members responded that the proposed rules will result in reduced funding and, consequently, loss of jobs in their organizations and, possibly, resulting in their having to close their operations. Members also strongly disagreed (80.9%) with CMS’ proposal to associate CME payments to faculty with a specific drug.
Members are very concerned about the negative impact the proposed rules on their faculty: 72% indicated that faculty will no longer participate in their activities that are funded any level of support from covered manufacturers if the proposed rules on CME payments recording and reporting are implemented as written. In addition, almost 95% of members believed that if CME is classified as a direct payment that it will reduce the number of CME activities produced per year.
Comments from NAMEC Members
“Readers of CMS-collected data will make no distinction between the widely different worlds of accredited CME and FDA-enforced promotional education. Therefore, just as we've seen CME-dedicated faculty and researchers leave paid positions as speakers and members of boards, we will see them leave CME. The public will not understand the distinction between CME and promotion, particularly if CMS inaccurately or misleadingly portrays the data collected (whether by accident or not). ……When one considers the serious morbidity and mortality of many disease states addressed by accredited CME providers in learner activities, every month’s or year’s delay has potentially great effects on quality of life and patients’ survival.”
“In my experience, faculty are participating in CME because they love to teach; they're not doing it for the money. Having their names associated with a supporter (with whom they may or may not have a bona fide relationship) when their real relationship is with the CME provider will not be worth the scrutiny and aggravation. I believe that many will simply elect not to participate.”