Life Science Compliance Update

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.  

October 12, 2017

AMA/ACCME Alignment Implementation Now Live

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The American Medical Association (AMA) and the ACCME are working together to develop a list of frequently asked questions (FAQ), instructions for designating credit, and other resources that will be available by the end of September. These resources will support CME providers’ implementation of the simplification and alignment of the requirements for accredited CME activities certified for AMA PRA Category 1 Credit™. The resources are posted here.

As previously announced, the simplification is reflective of the AMA and ACCME’s shared values and is designed to encourage innovation and flexibility in accredited CME while continuing to ensure that certified activities meet education standards and are independent of commercial influence. It is aimed at allowing accredited CME providers to introduce and blend new instructional practices and learning formats that are appropriate to their learners and setting.

The Framework was implemented based on feedback from the community and a review of the AMA PRA Category 1 Credit requirements. The alignment is designed to encourage innovation and flexibility, while ensuring that activities are independent and educationally appropriate. Accredited CME providers can introduce and blend new instructional practices and formats appropriate to their learners and setting, as long as they abide by the core requirements. CME providers may designate an activity format as “other” if it does not fall into one of the established format categories, without asking permission from the AMA. For these activities, providers can designate credits on an hour-per-credit basis, using their best reasonable estimate of the time required to complete the activity. The ACCME will modify the Program and Activity Reporting System (PARS) to enable providers to enter “other” as an activity type.

The core requirements for activities are:

  1. The CME activity must conform to the AMA/ACCME definition of CME.
    2. The CME activity must address an educational need (knowledge, competence or performance) that underlies the professional practice gaps of that activity’s learners.
    3. The CME activity must present content appropriate in depth and scope for the intended physician learners.
    4. When appropriate to the activity and the learners, the accredited provider should communicate the identified educational purpose and/or objectives for the activity, and provide clear instructions on how to successfully complete the activity.
    5. The CME activity must utilize one or more learning methodologies appropriate to the activity’s educational purpose and/or objectives.
    6. The CME activity must provide an assessment of the learner that measures achievement of the educational purpose and/or objective of the activity.
    7. The CME activity must be planned and implemented in accordance with the ACCME Standards for Commercial Support: Standards to Ensure Independence in CME Activities.

Some general tips are included below.

  • The simplification applies to all providers in the ACCME System, including state-accredited and ACCME-accredited-providers.
  • The AMA core requirements and ACCME accreditation requirements are aligned—and do not represent any new rules for accredited CME providers.
  • The AMA has simplified and reduced its learning format requirements to provide more flexibility for CME providers.
  • CME providers may design and deliver certified activities that use blended or new approaches to drive meaningful learning and change, as long as the provider abides by the AMA requirements.
  • CME providers may designate an activity format as “other” if it does not fall into one of the established format categories.

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