The CME Coalition has submitted their comment voicing serious concerns over CMS’s proposal to eliminate the CME exemption from Sunshine Act reporting. The Coalition notes that, as written, the proposed changes will have a detrimental effect on the professional training of medical professionals, and ultimately, on patient outcomes. The comment proposes a manner of determining bona fide accredited CME programs that are deserving of exemption from the Sunshine Act reporting rules.
CME Coalition Analysis of the Proposed Rule
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.
CMS stated that its motivation in eliminating the specific CME exemption in favor of the “indirect payment” carve-out was to “create a more consistent reporting requirement” and avoid the “apparent endorsement or support to organizations sponsoring continuing education events.” According to CMS, this remedy would result in an outcome where if a manufacturer conveys “full discretion” to the CME provider they are extending a grant to, payments the provider uses towards speaker fees or attendee tuition would be outside the scope of the rule.
Although this intended outcome seems to indicate CMS’s willingness to expand rather than eliminate the reporting exemption for CME payments, CMS’s proposal to replace the CME exemption with the “indirect payment” carve-out is virtually unworkable in the CME sphere. CME payments would have to be reported if a manufacturer becomes “aware” of the identity of the program’s speakers, faculty, or attendees within 18 months of its grant to the CME provider. Given the public nature of CME programs and the broad knowledge standard CMS has adopted, this is a virtual surety. Additionally, since CMS is proposing to implement this change in 2015, it could retroactively force commercial supporters to report indirect payments made as long ago as mid-2013. This would be a large administrative challenge and could even implicate constitutional concerns related to reasonable notice.
CME Coalition Proposal
The CME Coalition recommends 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.
First, they propose that CMS maintain an explicit definition in the Final Rule of “accredited or certified CME” in the definition section of the Final Rule. “We appreciate CMS’ desire to avoid listing specific accrediting bodies,” the letter states. “We have thus analyzed the requirements of accredited CME programs that receive commercial support to formulate a definition to include only bona fide accrediting bodies.”
Revise §403.902 (Definitions) to add “accredited or certified continuing education program”:
A. An educational activity designed, sponsored or hosted by a third party organization that is accredited or certified by an accrediting body or organization that is recognized by a state or federal government. The accrediting body or organization must:
- Have standards regarding the acceptance and use of payments or other transfers of value from applicable manufacturers;
- Enforce compliance with these standards through audit, inspection, complaints, or otherwise;
- Have the authority to impose penalties for non-compliance with such standards, including loss of status or ability to offer credits to physicians;
- Require the third party organization to certify compliance with such standards on a regularly scheduled basis (e.g., bi-annually); and
- Not be owned or controlled, in whole or in part, by an applicable manufacturer
B. The educational activity can be in-person, online, or through other educational platforms.
C. The educational activity includes the value of the tuition or attendance fees, as well as any educational materials or items associated with the program (e.g., slides or handouts) as long as (i) the content is related to the educational activity; and (ii) the funds used for the materials came from the same financial
Second, understanding that the retrospective “awareness” standard becomes nearly impossible for accredited CME speakers, faculty and attendees, instead of removing Section 403.904(g), the Coalition recommends revising it to state:
(A) Payments or other transfers of value provided indirectly to physician speakers, faculty, or attendees at an accredited or certified continuing education program (as defined above) are not required to be reported if all of the following conditions are met. The applicable manufacturer must not:
- Select or pay the covered recipient speaker directly;
- Provide the CE/CME provider with a distinct, identifiable set of covered recipients to be considered as speakers; and
- Influence, invite or select the covered recipient-attendees or otherwise condition its financial sponsorship on the participation of particular covered recipients.
(B) The awareness standard (as defined in § 403.902) shall not apply to physician speakers, faculty, or attendees at an accredited or certified continuing education program.
The Coalition notes that “several factors strengthen the prospect and success of our proposal, while also ensuring that the spirit of the Sunshine Act and implementing regulations are not sacrificed.” These include the fact that the Coalition’s proposal “in no way alters CMS’s ability to audit or inspect an applicable manufacturer for compliance with truthful and accurate reporting.” Furthermore, “manufacturers would continue to attest to the truthfulness and accuracy of their annual payment reports.” Thus, CMS could continue to hold manufacturers accountable for any CME-related payments that should have been reported.
The comment also states that CMS should work closely with the CME Coalition, the Accreditation Council for Continuing Medical Education (ACCME), and related CME stakeholders to embrace a voluntary system in which the ACCME would recognize additional accrediting or certifying bodies that meet the ACCME’s Standards for Commercial Support. The ACCME Standards have been adopted by several accrediting bodies, who also have the power to audit and penalize any providers that fall outside of the Standards. This self-regulatory regime, ACCME and the CME Coalition believe, is preferable to Sunshine reporting.
In calling for CMS to adopt the Coalition’s proposal, CME Coalition Senior Advisor Andrew Rosenberg writes:
“We are passionate about accredited continuing medical education because we see the direct beneficial impact it has on physician excellence and patient outcomes. Forcing these indirect payments to be reported in the Open Payments system will have an unmistakable and chilling effect on physician, and commercial supporter, participation in CME. Any benefit that might be gained from requiring the publication of these payments is simply not matched by the predictable, negative impact on this vital component of our healthcare system, and we urge you to protect or expand the CME reporting exemption in your final rule.”