The American Academy of Family Physicians (AAFP) “strongly disagrees” with the Centers for Medicare and Medicaid Services (CMS) proposal to eliminate the continuing medical education exemption from the Sunshine Act. AAFP, which represents 115,900 family physicians and medical students across the country, wrote to CMS to outline their concerns that the proposal would create “an inadvertent barrier to the development and delivery of high quality certified or accredited CME with the final result of negatively affecting care provided to patients.”
AAFP notes that “CMS recognized that industry support for accredited or certified CME is a unique relationship that calls for a unique treatment,” in the February 1, 2013 Sunshine Act Final Rule. “That remains unchanged today.”
“Physicians must stay up to date on the latest medical research and medications so they can provide the most appropriate care to their patients,” AAFP states. “Each year, this research results in new treatment breakthroughs, medications, diagnostic procedures, and clinical guidelines.” Collaboration between physicians, device manufacturers, and pharmaceutical companies is critical, they argue, if “physicians are to remain current with the latest research and provide state-of-the-art care that the public deserves.”
Industry-supported accredited CME strictly adheres to the ACCME’s Standards for Commercial Support, AAFP states. “In recognition of this reality, CMS made the right policy decision when it issued the final rule indicating that indirect payments made to faculty at CME activities are not indirect payments…for purposes of the Open Payments program.” The current Open Payments Final Rule (Section 403.904(g)) exempts from reporting speaker payments and attendee tuition and materials for events that are accredited by one of five enumerated bodies, including the AAFP.
CMS is proposing to delete 403.904(g) in part because the agency considers it redundant with the “indirect payments” exclusion, Section 403.904(i)(1). However, these two sections are not the same. Without the clear CME exemption, manufacturers would be required to remain “unaware” of CME speakers and attendees for 18 months to be considered exempt from reporting. This awareness standard is very vague, and in the context of CME, almost impossible. “The parameters of the CME exemption in Section 403.904(g) are clear and unambiguous, and stakeholders have relied upon them in planning, developing, offering, attending and documenting CME programs…since the final rule was published,” AAFP states.
“To the extent that leaving both Sections 403.904(g) and 403.904(i)(1) in place creates some overlap or redundancy, no additional confusion or adverse consequences arise, but removing Section 403.904(g) in favor of 403.904(i)(1) would be trading the clearer and more certain provision for the murkier and more problematic one.” The letter notes that such an “unnecessary and ill-advised trade may chill participation in valuable CME activities and hinder the adoption and spread of important new therapies and medical information, which in turn may negatively impact patients.”
AAFP is recommending CMS leave the current 403.904(g) in place and also “reduce the administrative burden and potential over-reporting of indirect transfers of value through excluding CME activities where the industry donor is unaware of the speakers and other participants before committing to fund the activity.” In this way, CMS could both expand the educational events that are appropriately exempt from reporting, beyond the five enumerated bodies, “while simultaneously eliminating the potential for negatively impacting CME.”
The letter concludes by noting that “AAFP is disappointed CMS would suggest making such a sudden and significant policy change to the Open Payments program, especially during its infancy, since the proposed change would needlessly increase disruptions to the valid relationships between the medical professional community and the drug and device industries.”
“We urge CMS to stay its hand at this early stage in the implementation of Open Payments and to avoid hastily discarding the CME exemption, which was carefully considered before it was enacted and which remains critical to the education of our health care providers and consequently to the health of the public.”