The ACCME Complaints Process enables any CME participant, health professional, or member of the public who has concerns about CME to submit a complaint to us. We take complaints seriously and investigate thoroughly. Here are blinded summaries of complaints, which we publish to help CME providers and other stakeholders understand our requirements and process.
In some instances (for example, if a complaint is anonymous, the activity is beyond the timeframe for review, the entity not an accredited provider, or the activity not accredited), the ACCME does not pursue complaints. In those cases, the complainants are notified. Following are examples of these instances with brief descriptions.
- The activity that was the subject of the complaint was not offered by an ACCME-accredited provider.
- Legal matters that were the subject of the complaint were not relevant to ACCME requirements and outside the ACCME’s purview.
- An anonymous activity attendee suggested that one individual did not disclose to learners and also questioned the proximity of exhibits to educational space. The ACCME does not pursue complaints received anonymously, in accordance with its complaints process. However, the ACCME shared the complainant’s concern with the provider for its information since the complaint appeared to have come from one of its learners.
- The organization had changed its name; however, its former name may have been used in an activity accreditation statement. The ACCME asked the provider to ensure correct use going forward.
- An entity was using the ACCME accreditation statement on its website although it is not accredited. Because the organization is not accredited, the ACCME did not initiate a complaint, and asked the organization to discontinue use of the statement immediately.
- The complainant questioned the provider’s management of commercial support; however, the activities in question occurred more than 12 months ago. According to the ACCME’s complaints process, accredited providers are accountable for any complaint received by the ACCME within 12 months from the date a live activity ended.
- A nonphysician was displeased about being denied participation in an activity. However, an ACCME-accredited provider is allowed to design its activities for whomever it determines its learners are.
- The complainant submitted concerns regarding an activity “accredited” by the American Academy of Continuing Medical Education (AACME), an accreditor unknown to the complainant. The ACCME suggested the complainant contact the organization that is responsible for the activity. (For more information, see Warning: American Academy of Continuing Medical Education (AACME) and American Association of CME (AACME) are not ACCME-affiliated)
The ACCME received a complaint questioning a CME provider’s compliance with the ACCME’s CME Attendance Records Retention Policy because the learner had requested but not received a certificate of attendance from the provider. The ACCME requires CME providers to record and to be able to verify participation in CME activities; however providers can choose the process they use to fulfill this requirement. The ACCME does not require that providers issue certificates of attendance.
The ACCME issued a Notice of Complaint. In its response, the CME provider described its mechanisms to comply with the ACCME CME Activity and Attendance Records Retention Policy, explaining that it utilizes registration forms, sign-in sheets, evaluation forms, pre- and post-tests, and credit request forms, all of which are maintained for six years after the activity. The provider also indicated that it transmitted a copy of the attendance record to the complainant. The ACCME issued a Notice of Compliance. The complaint was closed.
The ACCME received a complaint regarding a jointly providership activity. The complainant questioned the CME provider’s compliance with the ACCME’s Attendance Records Retention Policy because the provider had not verified physician participation upon request.
The ACCME issued a Notice of Complaint. In its response, the CME provider explained that it could not obtain participation records on the series of activities because they were jointly provided and the joint providership is no longer in business. This revealed that the provider was not in compliance with three ACCME policies. The ACCME requires that the accredited provider must take responsibility for a CME activity when it is presented in cooperation with a nonaccredited organization. (The accreditation statement identifies the accredited provider that is accountable to the ACCME for compliance with ACCME policy. So, the accredited provider cannot blame the nonaccredited organization.) Secondly, under the ACCME’s expectations of jointly sponsored activities, it is the ACCME-accredited provider’s responsibility to be able to submit written documentation of compliance with accreditation requirements to the ACCME. Finally, the ACCME’s Attendance Records Retention Policy requires the provider to be able to produce verification of physician participation.
The ACCME issued a Notice of Noncompliance. As required, the CME provider submitted a Notice of Corrective Action, explaining that it had revised its organizational policies and procedures regarding verification of participation and it also chose to cease working in joint providership. The complaint was closed.
The ACCME received a complaint regarding an online enduring material offered by an accredited provider. The complainant indicated that the online enduring material did not communicate the following information prior to the start of the activity:
- Accreditation statement;
- Dates of the activity’s original release and most recent review or update; and
- Termination date.
The ACCME reviewed the online enduring material and sent the provider a Notice of Noncompliance. The provider was asked to add the above information to the activity, as required by the ACCME Policy on Enduring Materials, and to send the ACCME documentation to demonstrate that it had fulfilled those requirements.
The provider changed its online activity to include the required information and submitted screen shots and a narrative description of the changes it made. The matter was closed. The ACCME will survey the provider’s online enduring material(s) at the time of the next reaccreditation review to confirm that it continues to comply with ACCME policies.
Compliance with the ACCME's Standard for Commercial Support 2 and CME Clinical Content Validation Policy
The ACCME received a letter regarding an online activity about disease treatment offered by an accredited provider. The complainant alleged that one of the clinical care recommendations in the activity does not align with the recommendations currently accepted by the profession of medicine. The complainant also questioned whether the author’s potential conflicts of interest were identified and resolved.
The ACCME issued a Notice of Complaint to the accredited provider, asking about its compliance with the ACCME’s Criterion 7 (Standard for Commercial Support 2: Resolution of Personal Conflicts of Interest) and Content Validation Policy. The ACCME asked the provider to describe how the activity is in compliance with the ACCME’s Content Validation Policy and to describe and provide evidence of the implementation of its process to identify and resolve conflicts of interest in the activity.
In its response, the accredited provider explained that a month prior to receiving the ACCME’s Notice of Complaint, a learner had questioned the recommendations in the activity. In response to that inquiry, the provider had reviewed the activity content and as a result, made changes including the addition of more current references to support the activity’s clinical care recommendations and more description about the guidelines that include the clinical care treatment options in order to provide context for the recommendations. The provider also explained that it resolved conflicts of interest by validating that the content was based on best evidence as described in the medical literature and by vetting the content at multiple levels.
The ACCME determined that the provider’s own review and improvements to the activity addressed the issues in the complaint, and sent the provider a Notice of Compliance.
The ACCME received promotional material from a complainant regarding an Internet enduring material activity about medication adherence and treatment outcome within a class of drug therapies. The material suggested that the provider may have developed the activity because funding was available from a commercial interest, rather than because the content addressed the educational needs of its own learners.
The ACCME asked the accredited provider for more information about its compliance with the ACCME’s Accreditation Criteria 2, 3, 7 (Standard for Commercial Support 1: Independence), 10 (Standard for Commercial Support 5: Content and Format without Commercial Bias), and the Content Validation Policy. The organization was asked to submit information to demonstrate that the activity in question was in compliance with ACCME requirements.
The provider described and documented that the activity was designed internally by staff and presented reports and data to show how it incorporates into activities the educational needs that underlie the professional practice gaps of its own learners, as required by Criterion 2. The provider explained its process to ensure that the activity was developed independently of commercial interests (Criterion 7) and promoted improvements in health care and not the proprietary interests of a commercial interest (Criterion 10).
The ACCME issued a Notice of Compliance to the accredited provider and the matter was closed.
The ACCME received a letter regarding an enduring material offered by an accredited provider in joint providership with a nonaccredited provider. The topic of the activity was XYZ disease management. The complainant expressed concerns regarding the use of trade names and discussion of products, and claimed that the activity did not present a balanced view of therapeutic options. The ACCME asked the provider about its compliance with Accreditation Criteria 2, 7 (Standards for Commercial Support℠ 1, 2, and 6), 9, and 10.
The provider described the history of its joint provider relationship with the nonaccredited provider. It submitted information to demonstrate that the activity was developed based on the professional practice gaps of its own learners. The provider verified that all individuals in control of content provided disclosure information and that it identified and resolved conflicts of interest. The provider described implementation of a peer review process in which two independent individuals reviewed activity content and determined there was no commercial bias in the activity. The provider explained that the comparisons drawn in the activity between two products were impartial, balanced, and did not promote a specific proprietary interest of any commercial interest.
The matter was closed and the provider received a Notice of Compliance.
The ACCME received a complaint suggesting that an ACCME-accredited provider was conducting continuing medical education activities about the use of a health care product, “Product X.” The complaint described educational and business relationships that made it appear that the accredited provider stood to gain financially from the sale of Product X and that the manufacturer of Product X had the opportunity to influence the CME activity content. In addition, the complainant suggested that the accredited provider had an ACCME-defined relevant financial relationship with a commercial interest, and that the relationship was not addressed through the provider’s process for identifying and resolving conflicts of interest, and was not disclosed to learners.
The ACCME sent a Notice of Complaint to the accredited provider and asked for asked for its response to a series of questions, including the following:
- Do you stand to gain financially from the sale of the Product X?
- Describe and provide evidence of how your activities about Product X were planned and implemented free of the control of a commercial interest. Include a description of (a) identification of CME needs, (b) determination of educational objectives, (c) selection and presentation of content, (d) selection of all persons and organizations that were in a position to control the content of the CME, (e) selection of educational methods; and (f) evaluation of the activity.
- Describe and provide evidence of how conflicts of interest were identified and resolved in your activities about Product X.
- Describe and provide evidence of how relevant financial relationships were disclosed to learners in your activities about Product X.
In its response, the accredited provider communicated the following information:
- The activity in question was done in joint provdership and the joint provider had assured the provider of its independence from any commercial interests.
- The maker of Product X is an ACCME-defined commercial interest.
- The provider had failed to collect information from the individuals in control of content about their relevant financial relationships with the commercial interest, and was therefore unable to identify or resolve conflicts of interest.
- The presence or absence of relevant financial relationships for all individuals in control of content was not disclosed to learners. Instead, the provider reported that “faculty” had no relationships with any “funding source” and did not provide the names of faculty or others in control of content.
- Based on the complaint and internal discussion, the provider discontinued its activities about Product X. In addition, it discontinued its relationship with the joint provider.
The provider’s response confirmed that it was not in compliance with Criterion 7 (Standard for Commercial Support 2: Resolution of Personal Conflicts of Interest and Standard 6: Disclosures Relevant to Potential Commercial Bias); therefore the ACCME issued the provider a Notice of Noncompliance. The ACCME did not require the provider to take any further action because it had informed the ACCME that it would no longer offer activities related to Product X. The ACCME reminded the provider that it is responsible for ascertaining the compliance of its educational partner(s) with ACCME’s accreditation policies, the content of its CME activities, and the independence of its activities. ACCME-accredited providers are accountable for the compliance of their educational activities, including those that are offered in joint providership. The ACCME will include the information pertaining to the complaint in the provider's next reaccreditation review.
The ACCME received a complaint about a live CME activity. One faculty member was listed as having nothing to disclose; however, the complainant claimed that the person did indeed have relevant financial relationships with a commercial interest, as defined by the ACCME. Therefore, the ACCME sent a letter of inquiry to the accredited provider asking about its compliance with Criterion 7 (Standards for Commercial Support℠ 1, 2, and 6). The ACCME asked the provider to describe its planning process and indicate how each step was, in fact, independent, to describe how conflicts of interest were identified and resolved, and to document that the presence or absence of relevant financial relationships was made known to the learners.
The provider did not present evidence to demonstrate the implementation of a mechanism to identify conflicts of interest or to resolve conflicts of interest when relevant financial relationships were identified. For example, one of the speakers had relevant financial relationships with an ACCME-defined commercial interest. The relevant financial relationship was made known to the accredited provider, but it was not clear whether it was disclosed to learners. It was also revealed that individuals with relevant financial relationships were responsible for resolving their own conflicts of interest.
This was insufficient to demonstrate compliance with Standard 2: Resolution of Personal Conflicts of Interest, so the ACCME issued a Notice of Noncompliance and asked the provider to submit a Notice of Corrective Action, including evidence from a recently completed activity demonstrating compliance with Standard 2.
The provider’s Notice of Corrective Action documented changes to its policies and procedures. The provider continues to require that all individuals disclose to the provider and learners, including those with no relevant financial relationships. In addition, activity content is reviewed by content reviewers who have no relevant financial relationships. If necessary, the provider makes changes to activity content as a result of these reviews.
The ACCME accepted the provider’s Notice of Corrective Action. The ACCME will review the information pertaining to the complaint during the provider’s next reaccreditation review to ensure that the provider has continued to comply with Standard 2.
The ACCME received a complaint regarding a CME course. The complainant questioned the CME provider’s compliance with the ACCME’s Standard for Commercial Support 1: Independence because some of the speakers were employees of ACCME-defined commercial interests and appeared to be speaking on topics that were related to their company's line of business. The ACCME has said that employees of commercial interests cannot serve as planners or speakers in accredited CME activities if the content relates to their employer’s business lines and products.
The ACCME issued a Notice of Complaint. In its response, the CME provider explained that employees of commercial interests were not involved in planning or speaking about content related to their employer’s business lines or products. The committee had asked speakers from ACCME-defined commercial interests to present their perspective only on the regulatory hurdles involved in the drug and device approval process. This topic is not related to company business lines or products. These speakers were required to submit their presentations to the course director and the course director was required to provide a written attestation that the content was only on the regulatory hurdles involved in the drug and device approval process, valid, and in compliance with the provider’s guidelines, which are based on the ACCME Accreditation Criteria. The CME provider’s response demonstrated that the provider has mechanisms in place to ensure that employees of commercial interests were not involved in planning or speaking about content related to their employer’s business lines or products. The complaint was closed.