Life Science Compliance Update

January 30, 2018

CME Continues to Evolve for Providers and Practitioners

Whyisntlearn

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.

Pyramid

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.

January 18, 2018

Study Highlights Physician QPP Preparedness

Areyouprepared

Fewer than one in four physicians feel they are prepared to meet requirements under the CMS’ Quality Payment Program (QPP), a new American Medical Association and KPMG survey shows. Out of 1,000 physicians involved in practicing decision-making related to the QPP, only 8% said they were “deeply knowledgeable” about MACRA and QPP. In contrast, almost 92% said they were “somewhat knowledgeable” or not knowledgeable. All of this spells danger for the new program as CMS struggles to inform physicians about the new requirements even as a performance year has almost already been completed.

Study Results

According to the study, 7 in 10 respondents had in fact begun preparing to meet the requirements of the QPP for 2017. Nearly 9 in 10 feel somewhat prepared or well prepared to meet the low-bar requirements set forth by CMS in the first year. Of those participating in the MIPS track of QPP, only 65% felt prepared to meet the requirements, indicating that alternative payment model members have a higher likelihood of feeling prepared. Additionally, of those participating in MIPS, 90% felt the requirements are slightly or very burdensome, with over half responding they were at the higher level of burden.

Respondents to the survey indicated the reporting time required to comply is the most significant challenge and suggest it will be one in future years. Respondents also struggled to understand requirements like MIPS scoring and the cost of reporting.

Previous programs like PQRS and the VBPM contributed to the level of readiness for QPP. The legacy programs set up physicians to be more successful than those with no experience with them. Only 25% of physicians with prior reporting experience felt well prepared for the QPP, however.

An interesting finding in the study is that even among those who feel prepared, they do not fully understand the total impact of the QPP. While they may be prepared to check boxes and complete forms, they lack “long-term strategic financial vision to success in 2018 and beyond.” Only 8% of respondents feel they are very prepared for long-term success with 26% feel not prepared at all.

Findings Support Number of Assumptions About QPP

According to the study, its results confirm assumptions that are widely held regarding physician knowledge and preparedness for QPP requirements:

  • Some challenges are universal regardless of practice size, specialty, or previous value-based payment experience, particularly the time required and the complexity of reporting.
  • Physicians, especially in small practices, need more help to prepare.
  • Physicians want more alternative payment models available to them.
  • Physicians with value-based payment reporting experience are more confident about their preparedness regarding performance under MIPS.
  • Physicians remain deeply concerned about the long-term financial ramifications of the QPP.

October 12, 2017

AMA/ACCME Alignment Implementation Now Live

Amaaccme

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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