Life Science Compliance Update

June 08, 2015

Communicating the Value of Accredited Continuing Medical Education

ACCME

Graham McMahon, who began his tenure as President and Chief Executive Officer of the Accreditation Council for Continuing Medical Education (ACCME) last month, announced a new resource that CME providers and other stakeholders can use and distribute to communicate the value of accredited CME. “The resource describes how accredited CME promotes engagement with healthcare professionals by providing them with opportunities for relevant, practice-based, independent education and improvement in a system that meets their needs, and promotes quality in patient care,” he states. The document includes facts about CME’s effectiveness, independence, and responsiveness to the evolving healthcare environment.

View the resource here: The Value of Accredited Continuing Medical Education

The document consolidates much of the reports, research, and policies that the ACCME has articulated in the past few years.  

First, research shows that CME has a positive impact on physician learning, performance, and patient outcomes, notes the ACCME, which provides a link to a comprehensive study released last year that convincingly demonstrates the impact of CME on physician performance. The research also demonstrated that “CME is most effective if it is founded on practice-based needs assessment and is ongoing, interactive, and focused on outcomes that are considered important by physicians.”

The ACCME then outlines how CME promotes physician learning and improved outcomes:

  • Each CME activity is designed to meet the practice-based educational needs of the learners.
  • Each CME activity addresses one or more of the professional competencies established by the Accreditation Council for Graduate Medical Education (ACGME)/American Board of Medical Specialties (ABMS), Institute of Medicine (IOM), or Interprofessional Education Collaborative (IPEC).
  • Each CME activity must be designed to change competence, performance, or patient outcomes. CME providers are then required to analyze the changes achieved as a result of the activities.
  • Almost 100% of activities are designed to change competence. More than 50% are designed to change performance. More than 20% are designed to change patient outcomes.
  • More than two-thirds of accredited CME programs demonstrate that they integrate CME into the process for improving professional practice.  
  • About two-thirds of accredited CME programs demonstrate that they participate within an institutional or system framework for quality improvement.
  • With 140,000 activities comprising one million hours of instruction delivered annually, accredited CME offers an array of resources to promote quality, safety, and the evolution of medical care

ACCME also describes how CME can be delivered in flexible and diverse formats in order to meet the needs of individual learners. “Accredited CME offers multimodal educational opportunities” including “simulation, online courses, self-directed performance improvement projects, participatory group learning, hands-on training, and just-in-time learning at the patient's bedside,” they state. The ACCME allows for providers to choose the format the best meets their objectives and notes “[a]ll activity formats (eg, didactic, small group, interactive, hands-on skills labs) are perfectly acceptable and must be chosen based on what the provider hopes to achieve with respect to change in competence, performance, and/or patient outcomes.”

The ACCME next identifies the “perception versus reality” of industry-funded CME. “The hallmark of accredited CME is its independence from commercial influence and bias,” they state. The resource outlines a number of important facts about industry funding of continuing medical education:

  • Most CME revenue is not derived from commercial support. Commercial support accounted for 26% of revenue in the accredited CME system in 2013.
  • The majority of CME activities (83%), accounting for 80% of participants, do not receive commercial support.
  • Since 2010, the first year the ACCME presented data about commercial support at the activity level, the percentage of activities receiving commercial support has decreased 3%.
  • The ACCME Standards for Commercial Support have evolved into a common interprofessional standard shared by continuing education accreditors across the health professions. The value of the Standards has been recognized by government, regulators, and industry.
  • Research has demonstrated that commercial support does not increase the risk for commercial bias when CME providers abide by the ACCME Standards for Commercial Support. (see the report entitled “Is There A Relationship between Commercial Support and Bias in Continuing Medical Education Activities? An Updated Literature Review”)

The ACCME also outlines how accredited CME has contributed to public health initiatives. They indicate that the recognition that accredited CME is independent of commercial bias “has enabled public health collaborations that include commercially supported CME.”

For example, the Food and Drug Administration (FDA) mandated that industry fund accredited CE about safety and risk issues involved in prescribing opioid medications. The FDA is now considering other ways to work together with the CE community to advance public health, the ACCME states.  The ACCME also provides ongoing support for the initiative led by the National Human Genome Research Institute, National Institutes of Health, to improve the integration of genomics into health professionals’ continuing education and practice. Further, the ACCME convenes Public Health Imperatives Forums at its CME as a Bridge to Quality™ Accreditation Workshops, which bring together government representatives and accredited providers to identify opportunities for CME to be a strategic partner in addressing public health priorities.

The ACCME also “partnered with its colleague accreditors in nursing and pharmacy to create the only interprofessional continuing education (IPCE) unified accreditation program in the world—Joint Accreditation for Interprofessional Continuing Education™,” states the ACCME. “Joint Accreditation offers organizations the opportunity to be simultaneously accredited to provide medicine, pharmacy, and nursing continuing education activities through a single, unified application process, fee structure, and set of accreditation standards.”

Finally, the ACCME resource outlines how they have responded to evolutions in the healthcare community. They include, for example:

  • The Standards for Commercial Support were updated in 2004 to further strengthen the separation of education from promotion.
  • The ACCME has increased accountability and transparency in recent years. The accreditation process was accelerated to ensure more timely and rigorous oversight of issues related to independence. The ACCME published more data about accredited providers, including information about which providers accept commercial support.
  • The ACCME released new accreditation requirements in 2006 to reposition CME as a strategic asset to the quality and safety imperatives of the US healthcare system.
  • The ACCME implemented changes in 2014 to simplify the accreditation requirements and process and offer greater flexibility, while retaining the Plan-Do-Study-Act cycle which is integral to the ACCME’s expectations. These changes reflect the ACCME’s ongoing process of engagement with the CME and stakeholder communities.
  • As part of the ongoing engagement process, the ACCME issued a proposal for new commendation criteria. Developed collaboratively with the CE community, the proposed criteria aim to respond to current and emerging health priorities. The proposed criteria reward CME programs that address the integration of health data, interprofessional collaborative practice, individualized learning activities, and higher levels of outcomes measurement.

 

May 26, 2015

Continuing Medical Education: ACCME Offers New Guidance On The Role of Commercial Interest Employees In CME

Accme

The Accreditation Council for Continuing Medical Education recently provided clarity on the roles of industry employees in planning and delivering CME activities. ACCME’s Standards for Commercial Support require that accredited continuing medical education be independent and free of control of commercial interests, and employees of industry have been prohibited from participating in accredited CME. ACCME now makes clear that employees of industry can be engaged in a “specific, limited role” in certain aspects of continuing education. Murray Kopelow, President and CEO of the ACCME, notes that the new guidance fulfills ACCME’s mission to “support the free flow of scientific exchange while safeguarding accredited CME from commercial influence."

ACCME defines a commercial interest as any entity producing, marketing, re-selling, or distributing healthcare goods or services consumed by, or used on, patients. Specifically, under Standard 1 of the ACCME’s Standards for Commercial Support, an accredited CME provider may not allow a commercial interest to control or influence:

  • (a) Identification of CME needs;
  • (b) Determination of educational objectives;
  • (c) Selection and presentation of content;
  • (d) Selection of all persons and organizations that will be in a position to control the content of the CME;
  • (e) Selection of educational methods;
  • (f) Evaluation of the activity.

“The use of employees of ACCME-defined commercial interests as faculty and planners or in other roles where they are in a position to control the content of accredited CME is prohibited, except in the specific situations specified here,” states the ACCME in its new guidance, released last week.

The ACCME identified three “special-use cases where employees of ACCME-defined commercial interests can have a specific, limited role in accredited CME activities.” ACCME notes that there are circumstances where an employee of an ACCME-defined commercial interest can make a scientific presentation within accredited CME about their company’s research and still be compliant with the ACCME Standards for Commercial Support.

  • (1) Employees of ACCME-defined commercial interests can control the content of accredited CME activities when the content of the CME activity is not related to the business lines or products of their employer.

  • (2) Employees of ACCME-defined commercial interests can control the content of accredited CME activities (e.g., as planners, authors, or speakers [including poster presentations]) when the content of the accredited CME activity is limited to basic science research (e.g., pre-clinical research, drug discovery) or the processes/methodologies of research, themselves unrelated to a specific disease or compound/drug. In these circumstances, the accredited provider must be able to demonstrate that it has implemented processes to ensure employees of ACCME-defined commercial interests have no control of CME activity content that is related to clinical applications of the research/discovery or clinical recommendations concerning the business lines or products of their employer.

  • (3) Employees of ACCME-defined commercial interests can participate as technicians in accredited CME activities that teach the safe and proper use of medical devices. In this circumstance, the accredited provider must demonstrate that it implements processes to ensure that employees of ACCME-defined commercial interests have no control of CME activity content that is related to clinical recommendations concerning the business lines or products of their employer. 

ACCME also makes clear that, as in every accredited CME activity, the expectations of ACCME’s Standards for Commercial Support for the three situations must be met.

The new guidance included FAQ-type scenarios that show how ACCME's new policies would play out in the workplace. See "Examples of Compliance and Noncompliance" here

An accredited provider would be in compliance, for example, with ACCME standards where:

  • An employee of an ACCME-defined commercial interest participates as a teacher in an accredited CME activity whose content is about the drug discovery process, itself, and is not about treatment or diagnostics. The activity is targeted to scientists whose research is focused on drug discovery.

  • An employee of an ACCME-defined commercial interest participates as an author and presenter in an accredited CME “Scientific Poster Session” where the content of their presentation is limited to reporting research results (e.g., biology, physiology, physics) early in the drug discovery process so as to not include any discussion of product development. The provider demonstrates that the CME activity does not include any discussion or clinical recommendations concerning the use of products or devices of ACCME-defined commercial interests that could be used or prescribed for patients.

  • An employee of an ACCME-defined commercial interest participates as a planning committee member, author, and trainer in an accredited CME activity on disaster management preparedness. In its Performance-in-Practice evidence, the provider demonstrates that the content of the CME activity (“disaster management”) is not related to the business lines or products of the employer, a medical device manufacturer.

  • The accredited provider plans an intensive hands-on course to train physicians to perform vascular interventions using new FDA-approved medical devices and equipment. The course director asks several ACCME-defined commercial interests to provide equipment and medical devices for use in the CME activity and also to provide technicians (i.e., employees of the commercial interest) to operate the equipment during the CME activity. The accredited provider tracks the loaned equipment as in-kind commercial support. The course director plans the CME activity independent of the control of ACCME-defined commercial interests; she determines what procedures will be taught, instructs the commercial interest employees on their limited roles, and is present to oversee and participate in the instruction. The course director monitors the CME activity to ensure that demonstration and comments provided by the device technologists are technical only (i.e., about the safe and proper use of the equipment) and do not include clinical recommendations about the medical devices/equipment of the manufacturer(s).

A provider would NOT be in compliance where:

  • The accredited provider uses an employee of an ACCME-defined commercial interest—a company that distributes pharmaceuticals—as faculty for a CME activity. From its Performance-in-Practice materials and subsequent accreditation Interview, it is determined that the provider failed to identify a pharmaceutical distributor as an ACCME-defined commercial interest because the forms it used to identify relevant financial relationships included language that did not accurately reflect all of the types of organizations included in the ACCME’s definition of a commercial interest.

  • The accredited provider uses employees of ACCME-defined commercial interests as members of a CME committee that determines topics and speakers for accredited CME activities related to the products of their employer(s). In its Performance-in-Practice materials, the provider shows that it identifies relevant financial relationships for members of the CME committee and manages conflicts of interest using several strategies (e.g., peer-review of content, recusal from discussions related to their financial relationships). The identification and resolution of conflicts of interest (Standard 2 of the ACCME Standards for Commercial Support) is not a valid mechanism to ensure independence, as employees of ACCME-defined commercial interests cannot control the content of CME activities related to the business lines and products of their employer, per Standard 1.

  • The accredited provider uses employees of ACCME-defined commercial interests as authors and speakers in CME activities related to the business lines and products of their employer(s). In its Self-Study Report and Interview at reaccreditation, the provider describes that it ensures the independence of its CME activities by having commercial employees attest that the content they present about commercial products is ”fair and balanced.” This is not an acceptable mechanism to ensure independence, as employees of ACCME-defined commercial interests cannot control the content of accredited CME that is related to the business lines and products of their employer.

----

ACCME's latest guidance and accompanying FAQs are welcomed instruction. The policies that ACCME sets forth here can be traced to a 2010 controversy involving whether industry scientists would be able to present CME at an American Heart Association conference. The ACCME and AHA eventually reached an agreement, and ACCME released guidance that closely parallels what they have now released, five years later.  

 

Newsletter


Preview | Powered by FeedBlitz

Search


 
Sponsors
July 2015
Sun Mon Tue Wed Thu Fri Sat
1 2 3 4
5 6 7 8 9 10 11
12 13 14 15 16 17 18
19 20 21 22 23 24 25
26 27 28 29 30 31