The CME Coalition has submitted comments to CMS regarding Open Payment’s impact on CME, including the impact on the distribution of journal reprints and medical texts. As the letter explains, “upon publication of the rule in 2016 there was a significant pause in funding for accredited CME as commercial supporters tried to assess the interaction of the rule and its sub-regulatory guidance.” The letter goes on to note that while a majority of stakeholders have interpreted the FAQs to exclude most independent, accredited CME activities from the definition of “payment,” the Coalition remains concerned that “if CMS were to ever make changes to the rule or FAQs to require reporting for independent CME, we would see significant reductions in both funding of and participation in accredited CME programs.”  Further, the letter details the extensive barriers preventing the slightest industry influence from entering the accredited educational content that our members support, provide and rely upon — specifically citing the Accreditation Council for Continuing Medical Education’s (ACCME) Standards for Commercial Support (SCS) that have been adopted by many accrediting organizations. 

At the 16th annual CBI summit on independent medical education and grants, the CME Coalition's Andy Rosenberg outlined the major legislative and regulatory issues that the Coalition has been engaged in throughout 2018. 

​In a letter to Centers for Medicare and Medicaid (CMS) Administrator Seema Verma, the CME Coalition urged the agency to provide an exemption for CME and certain educational materials from the reporting requirements of the Physician Payments Sunshine Act. “We strongly believe that commercial support payments for CME that do not meet the Sunshine Act’s definition of payments should be definitively exempted from reporting,” writes CME Executive Director Chris Lamond. “As a nation, we should be encouraging and facilitating accredited physician continuing education, not stigmatizing it by requiring the collection and reporting of payments that underwrite it.” The letter also notes that while the current FAQ #8165 provides CME stakeholders with solid guidance regarding independent commercial support for CME activities, the numerous updates to the policy via these FAQ updates leaves stakeholders with a need for certainty that only a definitive Final Rule can deliver. 

Yesterday, the Centers for Medicare and Medicaid Services (CMS) posted a revised FAQ on its Open Payments website regarding the reporting of CME-related payments. The revised FAQ 8165, which is provided below, replaces an earlier FAQ on the same subject by providing greater specificity with regard to the exclusion of certain CME-related payments from Sunshine Act reporting that meet the standards outlined by CMS. We believe that while this FAQ is fully consistent with our earlier interpretation of the status of independent CME-related payments when CMS revised the regulations in 2014, as well as the interpretation of other leading stakeholders like the American Medical Association, the revised FAQ now provides even greater clarity to stakeholders. 

In a letter to Sen. John Barrasso (R-WY), the American Medical Association and dozens of specialty groups and state medical societies offered their support to legislation sponsored by the Wyoming senator that would exempt continuing medical education (CME) activities from Sunshine Act reporting requirements. The groups urge prompt passage of the legislation, citing confusion around Centers for Medicare and Medicaid Services (CMS) rules and the effect those rules have on the publication of medical textbooks and peer-reviewed journals. 

In a letter to Sen. John Barrasso (R-WY), the CME Coalition applauded the Senator for his recent introduction of legislation which appropriately exempts CME and certain educational materials from the reporting requirements of the Physician Payment Sunshine Act (Sunshine Act). As the Coalition writes to Sen. Barrsso, who is also a practicing physician, "While the Sunshine Act intended to make payments from commercial entities to physicians more transparent, we believe that the Centers for Medicare and Medicaid Services’ (CMS) has confused and misread Congressional intent, providing a mix of regulatory interpretations that have called into question whether independent, accredited CME activities could also be subject to the law’s reporting requirements... Your approach, which enjoys significant bipartisan support in the House of Representatives, and was overwhelmingly passed by that body as part of the “21st Century Cures” legislation, will help end much of the confusion among physicians and within the CME stakeholder community. We believe that your bill will reduce physician reluctance to participate in accredited CME by eliminating the “chilling effect” that exists today as a result of Open Payments reporting. We look forward to your bill’s consideration and passage by the full Senate. "

A legal advisory from the American Medical Association (AMA) presents the Sunshine Act reporting requirements for continuing medical education (CME), and concludes that AMA certified and ACCME accredited programs "are exempt from reporting by commercial supporters."  Consistent with the October 2014 guidance issued by the Centers for Medicare and Medicaid Services (CMS), AMA concludes that when an “applicable manufacturer conveys ‘full discretion’ to the continuing education provider, those payments are outside the scope of the rule” and thus, not subject to reporting.  AMA goes on to highlight the strict firewall that exists between commercial supporters and CME program participants, adding that "the rules of accreditation strictly prohibit any commercial supporter from having any direct or indirect influence or control with respect to the content, faculty, speakers, or attendees of an AMA certified or ACCME accredited educational program or activity.​"​

In response to questions about the Sunshine Act 'reportability' for transfers of value related to the provision of accredited CME events, the CME Coalition has developed ‘template’ grant language for use in CME agreements between commercial supporters and providers.  The template included below, drafted with expert legal counsel from Arnold and Porter, includes language that tracks directly with CMS’ guidance indicating that supporters have not “directed, instructed or caused” the CME provider to pay specific covered recipients.

In a letter to House Energy and Commerce Chairman Fred Upton (R-MI) and Ranking Member Frank Pallone (D-NJ), the CME Coalition "wholeheartedly endorses" the Committee's passage of the 21st Century Cures Act (H.R. 6), along with the inclusion of a provision to exempt CME and certain educational materials from the reporting requirements of the Physician Payment Sunshine Act.  As an organization that represents a collection of continuing medical education provider companies, in addition to other supporters of CME and the vital role it plays in our health care system, the CME Coalition recognizes the importance of ensuring that physicians are encouraged to continue in their professional development. That's why the Coalition has come out in strong support of the provision to ensure providers that continuing medical education events will continue to be exempt from the Sunshine Act's reporting requirements.