On September 26, the CME Coalition submitted comments responding to the Food and Drug Administration (FDA) updated draft guidance regarding diversity action plans (DAPs) in clinical studies. This comment opportunity provided a valuable opportunity for the CME Coalition to engage in conversations about the importance of ensuring health equity in medical product development and, ultimately, health care outcomes. 

​After several meetings of our diligent working group, we developed comments that emphasize the role of CE providers in promoting health equity by ensuring care providers are educated on diversity action plans and outlines how CE helps bridge the gap in trial participation among underrepresented populations through increased collaboration with the FDA. 

In recent years, Social Media (SM) has emerged as an essential global communications channel for healthcare stakeholders, including the continuing medical education community. With SM’s growth in influence, we have increasingly received questions from our membership and the public at-large regarding the proper use of this new medium in furtherance of continuing education activities.

​The CME Coalition is proud to share this Compliance Guide, initially published December 2023 and updated April 2024, which represents the best answers we can provide in response to the range of questions we have received.

On January 5, 2024, the CME Coalition submitted comments to the Food and Drug Administration (FDA) regarding its recently issued draft guidance for industry regarding communications from firms to health care providers about scientific information on unapproved uses of approved medical products. 

​The CME Coalition expressed support for the recommended disclosure of firm generated communications while also suggesting an additional requirement that any other company-led education activity prominently disclose the extent of the company’s involvement. 

The CME Coalition on November 8 submitted comments to the European Accreditation Council for Continuing Medical Education (EACCME) regarding its revised criteria, otherwise known as EACCME 3.0.  Among other items, the criteria places restrictions on promotional materials and satellite symposiums for CME. The submitted comments outline several of the Coalition's concerns regarding this criteria, as raised by members of the Coalition's working group to develop this letter, including the outlawing of satellite symposiums and the EACCME's lack of providing a public comment period on the revisions. 

After several meetings of the Coalition's working group to discuss recent guidance proposed by the Accreditation Council for Continuing Medical Education (ACCME), the CME Coalition submitted comments on October 6 to the ACCME in response its Call for Comment on Accredited Education Delivered via Online and Social Media Platforms. While the CME Coalition appreciates the endeavor of the ACCME in proposing this guidance, we believe that additional research and clarity is required to adequately protect Accredited Providers from the unintended consequences of producing online CE and simultaneously support innovation. 

As a result of our conversations during past CME Coalition monthly meetings on the subject, the CME Coalition submitted public comments today in response to certain proposed policies included in the Centers for Medicare and Medicaid Services’ (CMS) proposed rule on the Medicare Physician Fee Schedule for calendar year (CY) 2023.

The CME Coalition expressed our strong support for the addition of national CME accrediting organizations and providers as new third-party intermediaries able to directly report clinician completion of accredited CME and/or Maintenance of Certification (MOC)
improvement activities for the Merit-based Incentive Payment System (MIPS) Value Pathways. As discussed in more detail in the attached letter, we communicated that we believe the inclusion of CME organizations as a third-party intermediary in this capacity would allow for reduced clinician burden as well as a heightened clinician focus on patient care, particularly with regard to metrics of priority to CMS.

The CME Coalition held a virtual webinar on June 29, 2022 following the issuance of its new compliance guide, Independent Medical Education (IME) Compliance Guide, for use by accredited CME providers and commercial supporters. The IME compliance guide additionally contains FAQS for non-accredited activities. The CME Coalition has produced this compliance guide and FAQs in response to numerous questions it has received regarding: (1) the Accreditation Council for Continuing Medical Education (ACCME) Standards for Integrity and Independence in Accredited Continuing Education, which have been adopted by several accrediting bodies; and (2) best practices for education providers and the industry to consider for non-accredited educational activities.

If you or any of your colleagues were unable to attend the webinar, its contents have been recorded and can be played back at anytime using this link. The passcode to access the recording is: 91TR*Q0v. You can also download a copy of the slide deck here when available. 
 
We hope you find this to be a valuable resource. Importantly, although the CME Coalition developed these FAQs in cooperation with our legal counsel, the document should not be constituted as binding legal advice from the CME Coalition, as the individual facts of any situation are likely to be unique.
 
If you have yet to obtain the IME Compliance Guide, you can request a copy of the guide via our website. 

Please reach out to Brittany Argote ([email protected]) with any questions.