Life Science Compliance Update

January 30, 2018

CME Continues to Evolve for Providers and Practitioners


Several articles about continuing medical education (CME) were recently published in the Journal of the American Medical Association (JAMA). One article discussed the importance of regulatory alignment with the boards while the other discussed the proposed CME pyramid.

CME Pyramid

Medical education is an evolving field and as of late, there has been an increased focus on addressing professional practice gaps – the gaps between what physicians are doing and what they should be doing. Therefore, an outcomes framework has been proposed in the form of a pyramid that provides perspective on how addressing these practice gaps may be accomplished.


According to the article, “[t]he pyramid is based on 7 levels of outcomes that are associated with the decisions of a clinician to participate in learning, to engage in learning, to use what he or she learned, and, at the summit, the effects of learning on patients and community. CME has traditionally been focused on learning (level 3) and in some cases on competence (level 4), which is similar to the “shows how” level of the pyramid in which a learner demonstrates to a teacher that he or she can do what has been learned.”

The article further notes, “It could be argued that if CME contributes to improving patient health on a broad front, such that many patients and many diseases are affected, then community health, that is, population health, must necessarily improve,” which is the impetus behind the push for all physicians and health care providers to be current on their education and continue learning for the benefit of their patients.

Cultural differences also plays a role in practice gaps and an analysis of health care in different countries shows how evident cultural differences are and that gaps in knowledge happen in developed countries like the United States and the United Kingdom.

The article also notes, however, that improvement cannot be achieved by CME alone, but will require the involvement of many different organizations. For example, this year the Centers for Medicare & Medicaid Services is proposing completion of an accredited CME program directed at performance or quality improvement. This Clinical Practice Improvement Activity must address a quality or safety gap that is supported by a needs assessment. The proposal has been endorsed by the Accreditation Council for Continuing Medical Education, which is now collaborating with the American Board of Medical Specialties to facilitate the integration of CME and maintenance of certification.

The CME pyramid works to bring each of the individual groups together to create a comprehensive solution to physician and provider education.  

Innovation through Regulatory Alignment

The President and CEO of the Accreditation Council for Continuing Medical Education (ACCME), Graham McMahon, MD, MMSc, and the Vice President for Medical Education at the American Medical Association (AMA), Susan Skochelak, MD, co-authored a piece published in JAMA on how to promote innovation through the regulatory framework. The article discussed the collaboration between the ACCME and the AMA to establish and credit CME activities in an attempt to support clinicians and developing learning opportunities.

The authors discussed the way the two groups collaborated on a strategy “to more closely align the 2 organizations’ requirements, simplify the system, and eliminate any barriers (perceived or real) that would constrain innovation in educational delivery. To develop their approach, the organizations convened listening sessions with various groups (including staff, volunteers, and leadership from accredited organizations and state medical societies), gathering feedback from physicians and educators about how to reconstruct the system to better support the evolution of CME.” It was through this process that a joint construct was formed.

“As part of the alignment, the AMA simplified and reduced its learning format requirements. There were previously specific requirements for 7 formats; now, there are specific requirements for only 3 formats: enduring materials, journal-based CME, and performance improvement CME. In addition, the requirements for these 3 format types were simplified, so that learning is prioritized. For example, the familiar posttests can be replaced with a self-reflective statement about what has been learned and how the learner plans to change; the outcome measure for a quality improvement effort can be locally determined.”

This flexibility will help physicians and CME providers alike learn more and be able to achieve more through CME.

To that end, the ACCME, in collaboration with the Accreditation Council for Pharmacy Education and the American Nurses Credentialing Center, created the first joint accreditation system to facilitate interprofessional continuing education. This program can serve as a model for accreditors in the health professions for developing systems that promote and facilitate team-based education by removing barriers between professions and expanding the delivery of interprofessional continuing education to facilitate measurable improvements in team performance.

McMahon and Skochelak noted that the success of this construct and the continuing success of CME is going to mean continuing evolution – including identifying needs and gaps in CME and adopting approaches that reflect “the same innovative spirit and nimbleness” expected of educational providers.

December 19, 2017

Report Issued on Third Annual Joint Accreditation Leadership Summit


On June 9, 2017, the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) participated in the third annual Joint Accreditation Leadership Summit. During this Summit, interprofessional continuing education (IPCE) professionals discussed various challenges and opportunities related to IPCE. 

The Summit was conducted in three parts and included discussion about publishing research and disseminating success stories about IPCE; case examples of research in action; and “hot topics” in IPCE, with attendees participating in breakout sessions to share and learn from each other’s experiences in managing IPCE programs.

A key recommendation of the previous year’s Joint Accreditation Leadership Summit was to build a body of research that demonstrates the effectiveness of IPCE in improving team performance and patient care. This year, the Summit focused on strategies for conducting and disseminating such research.

“We need to develop better models for sharing what works,” said Graham McMahon, MD, MMSc, President and CEO, ACCME. “We do that by looking at ourselves, looking at our programs, counting our wins, understanding the challenges we have, measuring that change, and sharing it with each other. That is research, and that is how we learn from each other.”

In the first session, participants explored how to design IPCE activities in a way that also produces data that can be published or otherwise shared with colleagues. Scott Reeves, PhD, MSc, PGCE, BSc, Professor in Interprofessional Research at Kingston University and St. George’s, University of London, and Editor in Chief of the Journal of Interprofessional Care, led the session. He offered insight to IPCE professionals about how to broaden their objectives to reach beyond their own institution and learners, including research and dissemination of outcomes that offer insight to the wider IPCE community. The purpose of gathering and publishing data, Reeves said, is two-fold: to understand the impact of activities on participants, and to disseminate those findings for the benefit of others.

The evaluation of IPCE activities is strengthened by the use of a theoretical perspective and evaluation model. Choosing a theoretical and/or evaluation framework can help to focus the work, as well as create more generalizable knowledge that contributes to scholarly work about IPCE. An evaluation model helps to capture a wider range of data and produce more comprehensive studies.

At the end of the day, Summit participants separated into four topic-based breakout sessions, led by their peers and Joint Accreditation staff. During this session, attendees had the opportunity to discuss a topic in-depth, to learn from each other’s experiences, and report back to the larger group. Topics included identifying educational gaps and needs for interprofessional teams; innovative strategies to evaluate change in interprofessional teams; identifying ways to recognize exemplary practices through accreditation with commendation; and further discussion on planning, conducting, and publishing IPCE research.

The Summit was designed to build a community of practice to sustain, stimulate, and nurture IPCE professionals. Through sharing stories and best practices, the growing community of practice advances the field, paves the way for future IPCE professionals, and generates collaboration with colleagues in undergraduate and graduate interprofessional education. With the support of their community, IPCE professionals will improve the care delivered to patients and communities across the country.

The report concluded with three key lessons for conducting research: creating a plan, developing partnerships, and sharing your results.

December 07, 2017

HCEA To Host Webinar on New International Ethics Rules


On Wednesday, December 13, 2017, the Healthcare Convention & Exhibitors Association (HCEA) will present a webinar entitled: “Preparing for the 2018 Ethical MeDTECH, APACMed and China Codes Impact on International Attendee Participation at US Meetings.”

As we have previously written about, beginning January 1, 2018, medical device companies in various regions of the world will no longer be able to directly sponsor participant’s travel to educational meetings. The Accreditation Council for Continuing Medical Education (ACCME) and other organizations have applauded this effort, as it furthers the independence of education and helps to align international codes with current United States standards.

However, because of financial constraints in many markets around the world, healthcare providers depend on outside support to attend US-based meetings. Therefore, it is possible that your annual meeting may see some changes in 2018 and beyond. This webinar will review the codes and explore some of the concerns expressed by medical meeting planners.

The webinar will be moderated by Policy & Medicine’s editor, Thomas Sullivan, and includes panelists: Aline Lautenberg, General Counsel and Director of Legal and Compliance at Eucomed, EDMA, and MedTech Europe; Matthew E. Wetzel, Vice President and Assistant General Counsel at AdvaMed; and Christine Wooster, Chief Revenue Officer at the Heart Rhythm Society.

Registration for the webinar is free for HCEA members and $50 for non-HCEA members. For additional information, contact Kristen Leikwold at or call (703) 935-1961.

To register for the webinar, click here.


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