Physician Payment Sunshine: Alliance for Continuing Education in the Health Professions Submits Comments to CMS
We have just hours to go before the deadline to submit comments to Centers for Medicare and Medicaid Services (CMS) on the proposed Physician Payment Sunshine rules at 5pm Eastern tonight is up.
The Alliance for Continuing Education in the Health Professions (“the Alliance”), formerly known as the Alliance for Continuing Medical Education, recently submitted its comments regarding Section 6002 of the Patient Protection Affordable Care Act (PPACA)—also known as the Physician Payment Sunshine Act.
The Alliance represents the nation’s top experts in continuing education for healthcare professionals and would be pleased to meet with CMS staff to provide further explanation, documentation and perspectives.
The Alliance offered its support for CMS’ efforts to shed light on direct payments from product manufacturers to physicians and other medical practitioners. However, after careful review, the Alliance urged CMS to exclude from reporting (1) indirect payments related to the provision of accredited and certified continuing medical education (CME) and (2) educational materials provided to healthcare providers that directly benefit patients.
The Alliance, echoing many other comments, noted how the original drafting of the Sunshine Act excluded indirect payments, such as industry support for continuing CME activities. Including payments to accredited CME providers could result in “serious unintended consequences for CME, and ultimately for patient care,” the Alliance said. Specifically, the Alliance noted that the potential consequences include:
- Reluctance on the part of physicians to serve as faculty or even to participate in industry-supported CME because the reporting requirements could result in the incorrect perception that these individuals are receiving some direct benefit from industry support;
- Burdensome reporting requirements for CME providers who already operate with limited resources and tight margins and would be required to determine the value of benefits that accrue to covered recipients attending CME programs; and
- A reluctance on the part of commercial supporters to fund CME activities due to the difficulty in calculating, tracking and reporting the indirect benefit of their support on faculty and participants.
The Alliance also urged CMS to make an explicit distinction between accredited and certified CME and promotional education, both in the final rules and any background materials provided on physician-industry collaboration. They noted how Promotional activities are controlled by manufacturers and may include both educational and marketing information. Whereas accredited and certified CME are evidence-based educational activities that are totally controlled by accredited CME providers from start to finish, and, if commercial support is involved, strictly follow the Standards for Commercial Support from the ACCME. No manufacturer is allowed to influence the design or offering of an accredited and certified CME activity in any way.
The Alliance produced a chart in its comment to CMS that illustrates how accredited and certified CME maintains its independence and how accredited and certified CME differs from promotional activities regulated by the FDA.
Their comment explains how, “Accredited providers select and reimburse all faculty members directly,” and that “applicable manufacturers are not allowed any input whatsoever regarding the selection of faculty, participants or content of these programs.” Accordingly, the Alliance asserted that, “reporting a link between applicable manufacturers and individual physicians who participate in CME activities (as faculty or participants) would result in a misrepresentation of these relationships as a direct benefit to the CME participant when, in fact, the benefit accrues to patients in the form of improved care.
Additionally, the Alliance recognized how commercial support of CME—which accounted for about 37% of the total revenue for over 19 million CME activities in 2010—is important to approximately 80% of CME providers and “allows them to foster quality patient care by disseminating knowledge and addressing performance gaps.”
“We believe an unintended consequence of the proposed rule would be to create burdensome tracking and reporting requirements both for CME providers and for applicable manufacturers. These requirements would harm CME business practices by diverting resources away from education and to administration and are likely to result in fewer educational opportunities for healthcare providers who treat patients.”
The Alliance also recommend that under exclusions, the definition of “educational materials that directly benefit patients” include an exclusion “for any enduring material that is accredited and certified for CME credit and for any educational material that is provided to supplement a certified activity.”
Conclusion
Ultimately, the Alliance emphasized how accredited CME providers already employ a system of checks and balances to ensure transparency, disclosure and resolution of conflicts of interest for accredited and certified CME by following regulations, guidelines and policies from the ACCME, the Food and Drug Administration, the Office of the Inspector General, the American Medical Association, and industry groups such as AdvaMed and PhRMA.”
They recognized how CME “content is developed independently, without input from applicable manufacturers, and it is reviewed prior to dissemination to ensure that there is no commercial bias. Serious penalties and consequences for violation of these requirements exist, including the potential loss of accreditation. Most importantly, these accredited and certified activities, as well as the educational material that supplements and supports the activities, result in improved patient care and health outcomes.”
In the end, the Alliance noted how, “assigning, calculating, tracking and reporting a value to individual faculty members and/or participants of accredited and certified CME would divert precious resources from education to administration (both for CME providers and applicable manufacturers).” Moreover, the reporting could result in a perception of a financial relationship between a healthcare provider and manufacturers that does not exist, perhaps implying impropriety on the part of the healthcare provider who participates in CME with the intent of teaching and/or learning how to improve patient care.
Accordingly, the Alliance strongly recommended exclusions for accredited and certified CME activities and supporting educational material in the final rule.