The Council of Medical Specialty Societies (CMSS), which represents forty-one societies with an aggregate membership of 750,000 U.S. physicians, recently submitted their comments to CMS regarding the proposal to eliminate the CME exemption from the Final Rule implementing the Sunshine Act. They ask CMS to keep Section 403.904(g)(1) as written for a number of important reasons.
1. The distinction must be made and maintained between accredited and certified CME, offered by accredited CME providers offering credit certified by the CME credit systems in medicine, contrasted with the promotional education of physicians, offered by companies. All providers of accredited and certified CME strictly adhere to firewalls established through the Standards for Commercial Support: Standards to Ensure Independence in CME Activities, promulgated by the Accreditation Council for Continuing Medical Education (ACCME), as revised in 2004, and universally implemented in accredited and certified CME.
CMSS asks the Agency to maintain the existing exclusion as written. “To eliminate the section specifically mentioning these [five accrediting and certifying] groups and standards opens the door for unapproved standards that are not universally accepted, and for groups outside of these to set standards which are not part of the CME accreditation system in the US. Such action would undermine independent CME in the US. It is unnecessary to risk this unintended outcome – CMS should simply retain the section of the Open Payments program which includes this limited number of accreditors and credit systems, and the standards (SCS) they all follow.”
The current Final Rule only exempts five bodies, however: ACCME, AOA, AMA, AAFP, and ADA CERP. “Should CMS wish to consider other accreditors or other equivalent standards, an extant mechanism exists to do so,” the letter states. “An inter-professional coalition of accreditors of continuing education in the health professions called, Joint Accreditation, has been convened since 2009 and is a collaboration of ACCME, the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC). This is the function of professional self-regulation, and does not require additional governmental regulation.”
2. Faculty at accredited and certified CME programs should not be subject to reporting under the Open Payments program as faculty relationships are with the accredited CME provider, not with any company which might grant commercial support to the CME provider. Grants to CME providers establish a relationship between the company and the CME provider, but not with the independent faculty.
CMSS believes that relying on the “indirect payments” standard, which is now proposed, is incorrect because speakers would be improperly reported this way. “First, CME programs are planned months, and sometimes years, and promoted in advance. Many CME programs are planned and promoted to their intended audiences far enough in advance that attainment of commercial support grants by the CME provider is incomplete.”
Furthermore, “as faculty are selected and identified during the activity planning process by the accredited CME provider, their names are promoted in the activity programing to the intended audience. It is not realistic, nor would it be perceived as transparent, if faculty names were hidden until the day of the program, nor would physicians attend such programs. As a result, over time during the planning process, even if the company does not request faculty names, companies providing commercial support to CME providers will potentially learn the names of the faculty, usually before the program, and certainly within two quarters after the program, through promotion of the program itself. Therefore, establishing a policy whereby an arbitrary determination of the presence of a relationship is made based on the timing of learning of the faculty names is unworkable – the names of faculty at CME programing cannot and should not be hidden.”
“CMS has agreed that a grant from a company to an accredited and certified CME provider does not establish a relationship with the faculty, due to the firewall established by strict universal adherence in accredited and certified CME to the ACCME SCS. Therefore, it is not necessary to undermine the recognition of the protection of the faculty by eliminating from the rule mention of the Standards which create the firewall, and replacing them with an arbitrary and unworkable timing proxy.”
3. Attendees at accredited and certified CME programs should not be subject to reporting under the Open Payments program as attendees have no relationship with any company which might grant commercial support to the CME provider.
Like the faculty, CMSS believes attendees may be inappropriately captured under the new proposal. “While attendees might not be identified in advance of a CME program, they are certainly identifiable during and after the program. 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.”
We encourage you to comment as well, by September 2, 2014. You may do so through the CME Coalition’s “Action Center” Portal.