September 2nd marked the last day for comments on CMS’ proposed rule to eliminate the accredited continuing medical education (CME) exemption from Sunshine Act reporting. In an overwhelming display of support for the exemption, over 800 comments were submitted encouraging the agency to either maintain or expand the current exclusion.
-Total comments supporting maintenance or expansion of the CME exemption: 820
-Total comments supporting elimination of the CME exemption: approximately 20
-Percentage of comments supporting the CME exemption: 98%
We have followed this issue closely, and recently analyzed the CME Coalition’s comments and recommendations, as well as the American Medical Association and Accreditation Council for Continuing Medical Education (ACCME).
Leading Medical Societies Submit Comments
In addition to the AMA, the major medical societies commented in favor of the CME exemption, including the American College of Physicians, the American College of Surgeons, the American Osteopathic Association (AOA), the American Academy of Pediatrics (AAP), and the American Dental Association (ADA).
Over 200 leading medical societies have submitted or signed onto comments to CMS urging the maintenance or expansion of the CME reporting exemption, including the following:
American Medical Association: On August 5, over 100 medical societies including the American Medical Association (AMA) wrote a letter to CMS urging them to modify the exemption slightly, so that the exemption applies to cases where the manufacturer doesn't select the speaker and doesn't know who the speaker is beforehand -- without addressing what happens afterward.
“Our organizations believe that this raises concerns as industry could learn the identities of speakers/faculty and potentially participants after the funds have been transferred through brochures, programs, and other publications, or through their physician-employees' participation in CE [continuing education] activities (either as speakers/faculty or attendees)… Our organizations are concerned that this would have a significant, chilling impact on CE, which runs contrary to the public interest.”
American Academy of Family Physicians: The American Academy of Family Physicians (AAFP) “strongly disagrees” with 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.”
“Physicians must stay up to date on the latest medical research and medications so they can provide the most appropriate care to their patients…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.”
Council of Medical Specialty Societies: The Council of Medical Specialty Societies (CMSS) submitted comments to CMS regarding the proposed elimination of the Sunshine Act’s CME exemption on August 19. The comments—on behalf of 41 medical specialty societies representing 750,000 physicians—advocate for the preservation of the February 2013 Final Rule to “retain in the Open Payments program the safeguards to distinguish independent accredited and certified continuing medical education from promotional education.” CMSS’ comments specifically address concerns regarding attendees at accredited CME events.
“While attendees might not be identified in advance of a CME program, they are certainly identifiable during and after the program,” the letter states. “However, CMS has always recognized that attendees have no relationship with companies which might choose to provide grants of commercial support to CME providers for accredited and certified CME. Therefore, it is not necessary to establish an arbitrary timing proxy for attendees. Attending accredited and certified CME does not establish a reportable relationship with any supporting companies.”
Accreditation Council for Continuing Medical Education: The Accreditation Council for Continuing Medical Education (ACCME) believes that CMS should not rescind the Sunshine Act's continuing medical education exclusion, according to a letter sent to the Centers for Medicare and Medicaid Services (CMS). ACCME, the membership based organization responsible for accrediting institutions that offer continuing medical education, expresses support for CMS' original position of excluding accredited CME from required reporting under the Open Payments program.
“The continuing education accreditation, activity approval, and credit systems of the American Academy of Family Physicians, the American Academy of Physician Assistants, the American Dental Association, the American Medical Association, the American Nurses Credentialing Center, the American Osteopathic Associations, and the Association of Regulatory Boards of Optometry already base their requirements on ACCME [Standards for Commercial Support]. Verification could be a next step in order to ensure unity in requirements and interpretation... We believe this would establish a valid mechanism to (a) retain a list of accreditation systems in which the [ACCME standards] are implemented... and (b) provide verification of this implementation using already existing processes within the system of professional self-regulation in accredited continuing education."
Pharmacists Groups: Four leading pharmacists groups—the Academy of Managed Care Pharmacy, the College of Psychiatric & Neurologic Pharmacists, the International Academy of Compounding Pharmacists, and the National Community Pharmacists Association—submitted comments to CMS. As representatives of pharmacy stakeholders, the organizations encourage the agency to “maintain a strong reporting exemption for accredited CME and to extend that exemption to programs for continuing pharmacist education (CPE) programs that are certified by bona fide [accrediting] bodies.”
“We believe that replacing the clear CME exemption with the category of 'indirect payments,' as your proposal suggests, will effectively eliminate the reporting exemption because commercial supporters will automatically report all of these payments rather than risking later discovery of the identity of these physician speakers… “[CMS should] promulgate very clear guidance under Open Payments that specifically exempts the reporting of all indirect support or transfers of value related to physician participation or attendance in an accredited CME program.”
Many other colleges and associations weighed in as well, offering thoughtful commentary in favor of maintaining the CME exemption.
The Medical College of Wisconsin noted that requiring manufacturers to report indirect payments to CME providers would have several unintended consequences, including misleading the public.
“The covered recipient and the applicable manufacturer are not contractually engaged. The covered recipient does not determine who the funders of CME activities are, the amount of funding, nor the allocation of said funding. The applicable manufacturer does not determine who the covered recipients are who participate in the CME activity, the nature of the participation nor the amount of participation. Given the unpremeditated nature of this circumstance, reporting CME would mislead the public in to presuming a relationship between covered recipients and applicable manufacturers where there is none.”
Furthermore, their letter states: “Any report generated as a result of the proposed rule, on monies received from applicable manufacturers that are not presented within a context of clinical /research performance may be detrimental to certain physicians. A physician may have a higher dollar amount attributed to her because she is renowned in her field with exceptional patient outcomes and has invented methods that not only improve patient care, but reduce healthcare costs. Another physician may also have a high dollar amount attributed to his practice, but he is not considered a leader in the field, does not keep current by attending CME activities and /or has poor patient outcomes. Yet without a proper context, patients will be misled into assuming there is no distinction between the physicians.”
The American Medical Informatics Association (AMIA), a medical specialty society with an interdisciplinary membership of 5,000 professionals and students committed to the science and practice of biomedical and health informatics, brought an interesting perspective to their comments, by stating that they don't currently accept commercial support. AMIA still urges CMS to reconsider their proposal:
“AMIA does not current (sic) accept commercial support for its certified CE activities. However, with the economic stresses impacting the practice of medicine today—such as implementation of electronic health record systems, already burdensome reporting requirements such as Meaningful Use, hiring of additional staff to manage the health insurance process, and ever-greater educational requirements to maintain competency—commercial support of our educational activities is certainly something we consider. We are sensitive to the fact that our members are paying significant sums to implement so many of the other changes that health reform demands and at a certain point will simply not be able to keep paying on their own for all of their continuing education and maintenance of certification materials.
“...CME providers are in jeopardy of losing their ACCME accreditation if they do not adhere strictly to these guidances. If the ACCME ascertains that an education provider is not in compliance, there is already a process in place to remove accreditation from that violator...Therefore, the proposed CMS expansion of the reporting requirement to include commercially supported CME activities does not recognize an already well-established divide between education and promotion. This level of reporting would jeopardize the commercial support funding of education that is essential to ensuring that today’s physicians remain competent."
“AMIA also urges exclusion of CME activities where the industry donor is unaware of the speakers and participants before committing to fund the activity. The commercial support landscape has changed greatly over the last decade. In fact, many commercial supporters do not want to know the name of faculty before awarding a grant for educational support lest this be interpreted as influence. Once CME providers have issued activity announcements, a commercial supporter’s knowledge of the faculty is inevitable. Commercial supporters’ knowledge of faculty after a grant has been awarded does not demonstrate influence any more than physician learners’ knowledge of faculty does.”
Hundreds of Individual Practitioners Voice Concerns
Hundreds of individual practitioners also reached out to CMS to voice their concerns regarding the proposed rule. Indeed, CME providers and medical specialists from around the country have submitted comments to CMS telling them that the proposed rule could have a chilling effect on CME, and could negatively impact patient care. Below is a small sample of public outcry elicited by CMS’ proposal, and the full archive of comments submitted on the entire proposed rule are available here:
Justine Gunvalsen, Ohio
“We develop valuable educational programs that are based on the latest evidence and guidelines. CME/CE is not a marketing tool but a highly regulated and important means of continuing education for healthcare providers. The goal of every activity that we develop is to provide clinicians with the tools needed to narrow their practice gaps and improve their clinical care while also empowering patients in their own care. We conduct the research and measure the educational outcomes to measure our achievement of this goal.”
“As the leading respiratory hospital in the U.S., our world renowned faculty are well-respected educators. I have spoken with faculty who say that if their involvement in CME activities, including honoraria payments, are reported under the Open Payments system, they likely will not participate as it implies they are doing something ‘wrong’… The proposed changes will cause confusion for physician learners who may find it harder to discern certified education from promotional activities if their participation is viewed in the same manner by CMS and the public.”
“I have already seen that the ‘Sunshine Act’ has discouraged international organizations from inviting US physicians to participate as speakers or attendees, because of the massive amount of paperwork involved in reporting ‘payments’ to US physicians. Misplaced regulation such as this decreases the availability of continuing education activities to US physicians and cuts us out of the mainstream of medical advances.”
Comments Calling for the Retention or Expansion of the CME Exemption