Life Science Compliance Update

December 19, 2017

Report Issued on Third Annual Joint Accreditation Leadership Summit

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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

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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 kleikwold@hcea.org or call (703) 935-1961.

To register for the webinar, click here.

November 30, 2017

ACCME Introduces Guidance for CME Providers on MEDTECH, APACMed and China Codes

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Recently, MedTech Europe, the Advanced Medical Technology Association (AdvaMed), and the Asia Pacific Medical Technology Association (APACMed) introduced changes to their respective codes of conduct relating to professional development activities, including continuing medical education (CME). As such, the Accreditation Council for Continuing Medical Education (ACCME) has offered guidance for CME providers with respect to the changes.  

Starting in 2018, it is expected that the revised codes will require member manufacturers to discontinue making direct payments to clinicians to fund their attendance at professional development activities. However, the manufacturers may continue to support the engagement of physicians in professional development and CME activities through grants that are given to health systems and employers, and through grants to accredited CME providers.  

Following the longstanding procedure, organizations that are accredited in the ACCME system may accept financial support for their educational activities from commercial entities (I.e., device manufacturers) under the revised codes and maintain independence from industry by following ACCME's Standard 3: Appropriate Use of Commercial Support.  

Standard 3 can be met by an accredited organization following the below criteria when accepting funding from commercial interests: 

  • Make all decisions regarding the use of the support, independent of any company or companies; 
  • Have a signed written agreement with the company that includes the specific terms and conditions of the support; 
  • Use the funds only for the educational activity and to offset the cost of participation to the learners as a whole;  
  • Not pay for travel, lodging, honoraria, or personal expenses for any non-teacher or non-author participants of the supported educational activity; and 
  • Disclose to all learners the source (and if in-kind, the nature) of the commercial support.  

The revised codes and ACCME requirements can be aligned together by ensuring that funds received from companies by organizations accredited in the ACCME system are not used to pay for any travel, lodging, honoraria, or personal expenses for any non-teacher or non-author participants. This ensures the accredited organization does not act as an intermediary to establish a relationship between an ACCME-defined commercial interest and the learners in an accredited activity, as well as helping to ensure clinicians' prescribing or device usage patterns are not inappropriately influenced.  

If an international learner receives funding from his or her hospital or other commercial entity not affiliated with the ACCME-accredited organization to participate in the education, the accredited organization is not prohibited from accepting that learner's registration and participation in the education.  

In a press release announcing the changes and the ACCME guidance, ACCME applauded the change, "since they bring industry standards in closer alignment with those that have existed here in the United States since 1992, and in doing so support greater transparency and independence in global medical education. ACCME also noted that the standards and principles in the revised codes are aligned even with the ACCME's own Standards for Commercial Support, which have been internationally recognized as a benchmark for independent medical education and adopted by other healthcare continuing education accreditors throughout the world.  

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