Despite the CME/pharma community’s efforts to self-regulate, allegations of bad behavior between life sciences companies and continuing education providers continue to make the front pages of newspapers across the country. Keynote presenters at the 21st Annual Conference of the National Task Force on CME Provider/Industry Collaboration, held in October in Baltimore, explored the current state of ethical, regulatory, and legal issues, and posited some ways both industry and providers can move forward despite today’s uncertain environment.
To meet today’s challenges, CME providers and commercial supporters need to understand how the culture surrounding what they do has changed. Darrell G. Kirch, MD, President and CEO of the Association of American Medical Colleges, Washington, D.C., presented at the opening keynote address a key question for this community: Is it possible to have principled partnerships between industry and CME providers in today’s environment? He focused on the culture of both industry and academia because, as he said, “culture eats strategy for lunch every day.”
Kirch said that the current individualized nature of academic medicine started when Abraham Flexner took medical education from the realm of proprietary, storefront medical schools back to the university. It was further ensconced when, after World War II, we began investing in research via grants given to individual investigators. And it’s only grown stronger since with the advent of Medicare and the fee-for-service care-delivery model.
The problem, Kirch said, is that healthcare is moving from being expert-centric to a team-based approach focused more on service than competition, and centered more on patients than on experts. Industry’s culture is undergoing a similar shift, he said. Historically it’s been all about profit, but now it’s moving from immediate shareholder returns to long-term sustainability, from focusing on market advantage to social responsibility, from secrecy to transparency, and from bottom line results to the “triple bottom line” of profit, people, and planet.
The need now, he said, is to rebalance the research portfolio to focus on patient and community engagement, and on delivery-system transformation, in addition to basic science and clinical discoveries. “One of our priorities should be fixing the science of fixing the healthcare system.”
He introduced a graphic that showed the continuum of medical education from pre-med, to medical school, to residency/fellowships, to continuing medical education. Kirch then showed another graphic that demonstrated how fragmented that continuum has become by the numerous accreditation and regulatory bodies involved in the varioius stages of the educational process. The challenge, he said, is to create a true continuum of medical education where learning and assessment are part of a smooth process that runs from pre-med through CME, and where everything taught in the earliest stages is designed to support high levels of physician competence in the later stages.
So, is the idea of achieving principled partnerships amidst this fractured continuum and ongoing culture change practical or a pipe dream? Kirch said the truth probably lies between the extremes of prohibiting all industry-provider relationships and allowing them to grow unfettered. But, he added, “Disclosure is not the perfect disinfectant.” We need to disclose, but we also need to prove that it is possible to achieve principled partnerships. “This will allow us to affirm our integrity while fostering innovation.”
This entails self-regulating, something that Norman Kahn Jr., MD, executive vice president and CEO, Council of Medical Specialty Societies, addressed in another session. He outlined the codes, standards, and laws already in place to manage conflict of interest, and the watchdogs ensuring that those codes, standards, and laws are followed, from the government, to the media, to the Institute of Medicine.
For accredited CME providers, the rules with the most teeth are the ’s Standards for Commercial Support, which providers must adhere to in order to maintain their accreditation. Kate Regnier, MA, MBA, deputy chief executive and COO of the ACCME, said that compliance has been improving since 2008. The highest rates of noncompliance involve Standards 2 (identification and resolution of COI) and 6 (disclosure to learners of information about relevant financial relationships for all who control content). The main problems are not collecting disclosure information from everyone involved, as opposed to just the , and similarly not providing disclosures to the learners from all involved.