Update: On October 31, 2014, CMS released a Final Rule redefining most CME payments as outside of the scope of the Sunshine Act's reporting requirements. This rule was reiterated in April 2015 guidance that details the circumstances in which CME payments are exempt from reporting.
In an effort to encourage the Centers for Medicare and Medicaid Services (CMS) to reverse course on their proposal to revise the Sunshine Act reporting requirements for accredited CME related payments, hundreds of individuals, companies, and organizations have submitted letters and comments to the agency. The full list of organizations who have submitted comments to CMS is available at the bottom of the page.
The CME Coalition submitted public comments to CMS on this proposal on August 29. In its submission, the Coalition embraces the preamble of CMS’s proposed rule, that the criteria for determining Sunshine-exempt continuing education should be expanded. However, the Coalition’s analysis of the proposed rule’s actual language suggests that rather than expanding the exemption beyond the originally designated “five accrediting bodies,” the proposal could instead require additional reporting for both speakers and attendees at CME events. The resulting elimination of the CME exemption could be devastating for the practice of CME.
In its place, the Coalition suggests specific language that it believes could meet CMS’s stated objective of designing a policy whereby “if an applicable manufacturer conveys ‘full discretion’ to the continuing education provider, those payments [should be] outside the scope of the rule,” and thus not reportable.
On September 18th, House Energy & Commerce Committee, Health Subcommittee Chairman Michael Burgess, M.D. (TX) and Ranking Democrat Frank Pallone (NJ) sent a letter to CMS Administrator Marilyn Tavenner regarding her agency's proposal to eliminate the CME exemption from the Physician Payments Sunshine Act. These two members represent the leadership of the House of Representatives Subcommittee with jurisdiction over most federal healthcare policy. It is a tremendous show of support for continuing medical education that they have come together from across the aisle to lend their voice to this effort.
In a concurrent effort with his congressional letter to the Centers for Medicare and Medicaid Services (CMS), Health Subcommittee Chairman Michael Burgess, M.D. (R-TX) partnered with Rep. Allyson Schwartz (D-PA) to introduced bipartisan legislation (H.R. 5539) to exempt both CME payments and the value of medical texts from the Sunshine Act reporting requirements.
On August 5, over 100 medical societies including the American Medical Association (AMA) wrote a letter to CMS. "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)," the letter states. "Our organizations are concerned that this would have a significant, chilling impact on CE, which runs contrary to the public interest."
Instead, the groups suggested, CMS could 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. The letter was also highlighted on Dr. Sanjay Gupta’s blog, The Gupta Guide.
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."
"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."
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. In CMS’ 2012 final rule, which is applicable under current law, the ACCME is one of the five enumerated accrediting bodies that seek to maintain the firewall between commercial support of CME and unscrupulous influence by drug and medical device companies.
The ACCME explains that “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."
On August 20, 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 -- wrote a letter to HHS Secretary Sylvia Matthews Burwell expressing concerns with a provision in CMS recent proposed rule which contains a provision regarding the criteria for exempting certain CME-related payments from reporting pursuant to the Sunshine Act. 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."
The letter reflects analysis of the proposed rule that has been shared by the CME Coalition and many others, that removing section §403.904(g) of the existing regulations would effectively eliminate the Sunshine Act exemption for CME. "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." The letter goes on to encourage CMS to "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."
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.
In order to obtain quality speakers, and CME program that will meet our current and future needs we need to be able to attract thought leaders with an ability to communicate their expertise to the physician community at large.
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.
*Links courtesy of Policy and Medicine.