Rockpointe, Inc. recently submitted comments regarding Section 6002 of the Patient Protection Affordable Care Act (PPACA)—also known as the Physician Payment Sunshine Act.
Founded in 1995, Rockpointe is a privately held business with twenty-eight employees located in Columbia, Maryland. Through its subsidiary company, Potomac Center for Medical Education (PCME), and other accredited organizations, Rockpointe/PCME plans and implements accredited continuing medical education (CME) activities for physicians, pharmacists and nurses.
Rockpointe/PCME is accredited by the Accreditation Council of Continuing Medical Education (ACCME) and the Accreditation Council for Pharmacy Education (ACPE) and strictly adheres to the ACCME Standards for Commercial Support and other relevant guidelines to ensure the independence of CME/CE activities.
Comments on Sunshine Act
Rockpointe expressed its concern that as written, the proposed regulations will have a detrimental, albeit unintended, effect on the professional training and education of medical professionals, and ultimately, patient care. They noted, as many others have, that it was never Congress’s intent to expand the public reporting requirements to include transactions related to the provision of continuing medical education when such payments are made from commercial interests to CME providers without allowing the supporting entity to exercise control regarding presenters, curriculum, or attendees of a given educational program.
As a result, Rockpointe recommended that CMS exempt from reporting any payments to accredited CME providers.
Moreover, Rockpointe noted its concern that CME providers will have to report the names of health care professionals who participate in their programs, which they said will deter overall participation and ultimately harm patients. Many of the CME programs Rockpointe does around the country take place at hospitals and are supported by multiple companies. Rockpointe noted that, if CME providers are required to report the names and information of participants at programs held at teaching hospitals because the supporter became aware of the identity of the hospital and knew the staff and physicians who worked at the hospital and attended our program, this would be a huge disincentive for the hospital to participate.
Specifically, the hospital would have to run a conflict of interest screening for all of the attendees and then check the accuracy of the payment data that is submitted for those who attended the program. There would also be difficulty calculating whether staff attending a CME program at a teaching hospital consumed food. To reduce the burden on CME providers and teaching hospitals, and to encourage greater participation in these programs, which will lead to better clinical practices and improved patient outcomes, Rockpointe urged CMS to exclude from reporting payments made to accredited CME providers.
Consequently, as a CME provider, Rockpointe’s comments specifically focused on the nature of the company, its role in providing CME, and the various internal policies, standards and procedures the company goes through to ensure compliance with various CME regulations. Rockpointe explained how it manages the whole CME process: from applying and drafting educational grant requests, managing funds, developing evidence-based content, recruiting faculty, and everything in between.
Rockpointe’s description of their robust and transparent procedures clearly demonstrate that the overwhelming majority of CME providers have in place significant firewalls to address any concerns the Sunshine Act was created to address. In addition, Rockpointe provided its detailed and structured procedures for addressing potential conflicts of interest and managing such potential conflicts through management, mitigation, and disclosure.
Rockpointe/PCME’s mission is to create clinically relevant and evidence-based educational interventions, which are objective and balanced. These interventions seek to bridge professional practice gaps and enhance physician competency.
The content of the activities designed and developed by Rockpointe/PCME include primary care and specialty topics within the field of medicine. All content is based upon evidence and addresses the body of knowledge and skills within medical science, the discipline of clinical medicine, and the provision of appropriate patient care. Moreover, as we have noted, Rockpointe programs have had positive patient outcomes in cardiovascular risk management, chronic heart failure, COPD, and hypertension.
Ultimately, Rockpointe concluded that, “the proposed reporting provisions of the Sunshine Act create a plethora of issues that were not considered upon inception.”
These conflicts may severely affect the ability of CME providers to produce effective educational activities.
Accordingly, they urged CMS to consider the burden on accredited providers to report to each covered manufacturer. Additionally, they noted that faculty payment disclosure has the potential to grossly misrepresent relationships between accredited CME providers, faculty, and manufacturers. Finally, they recognized that reporting information required by new guidelines also put accredited CME providers at risk of direct non-compliance with ACCME requirements.