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Our regularly scheduled series activity (e.g, pediatric grand rounds) includes many sessions that address different professional practice gaps and educational needs. Can we submit a single structured abstract for the entire series?

Yes. The Structured Abstract is intended to streamline, clarify and make more explicit ACCME’s expectations for verifying Performance-in-Practice. Using the fill-form fields on the structured abstract, the provider should state information representative of the entire series. It is permissible for the provider to summarize, or abstract, information from multiple sessions into brief statements on the abstract document. 

Our annual meeting is a very complex CME activity, with multiple tracks addressing several professional practice gaps and educational needs. Do we have to use a single structured abstract to submit our performance-in-practice evidence for this activity?

No. The Structured Abstract is intended to streamline, clarify and make more explicit ACCME’s expectations for verifying Performance-in-Practice. A single Structured Abstract can be used to for complex activities, however, you can also prepare separate structured abstracts for different tracks of a large annual meeting. Providers taking this approach should be sure that each structured abstract includes the required information and attachments.

Can you explain the ACCME 2006 Accreditation Criteria as they relate to a provider's process for continuous quality improvement?

The 2006 Accreditation Criteria are founded on Shewhart and Deming’s “Plan, Do, Study, Act” model for continuous improvement. This is reflected both in those accreditation criteria that are concerned with the improvement of a provider’s overall CME program, as well as criteria that guide the provider in planning and implementing CME activities to support continuous improvement of their learners’ practice and/or patient outcomes.

We make disclosure of commercial support as required by Standard 6.4 to our learners on our online registration portal. The opening screen includes the names and logos of our commercial supporters. Is that acceptable?

No. Logos of ACCME-defined commercial interests are not permitted in the disclosure of commercial support. The ACCME considers the disclosure of commercial support, as well as other information required by the ACCME such as disclosure of relevant financial relationships, to be part of the educational materials.

The April 2014 update to Standard 4.3 says that “Educational materials that are part of the CME activity” cannot contain corporate logos of an ACCME-defined commercial interest. What does the ACCME mean by “educational materials”?

Educational materials are those materials used by the accredited provider in the transfer of education to learners, as well as information required by the ACCME to be made known to the learner, such as disclosure of relevant financial relationships and/or disclosure of commercial support.  Examples include handouts, slides, educational content, abstracts (if part of the education itself).

Why did the ACCME change Standards 4.3, 6.4, and the Commercial Support Acknowledgment Policy to prohibit the use of ACCME-defined commercial interest logos in educational materials and disclosure of commercial support?

The ACCME made these modifications in March 2014 because it determined that the logos of ACCME-defined commercial interests —as a form of corporate branding —are not appropriate in either educational materials or in the disclosure of commercial support of accredited continuing medical education.

Can accredited providers include components in their CME mission statements in addition to the expected results described in Criterion 1?

Yes. Accredited providers can choose to include components in their CME mission statements in addition to those specified in Criterion 1. However, during the accreditation process, providers’ mission statements will be evaluated only to ensure that the mission statement includes “expected results articulated in terms of changes in competence, performance, or patient outcomes that will be the result of the program.”

Can accredited providers continue to use a monitoring system for regularly scheduled series (RSS) to demonstrate compliance with accreditation requirements?

Yes. Providers may choose any quality assurance method that works for them in order to ensure that their regularly scheduled series (RSS), and all their activities, are planned and presented in compliance with accreditation requirements. However, the ACCME does not require providers to use a monitoring system for RSS–or for any of their activities.

When are accredited CME providers expected to implement the change in terminology from “sponsorship” to “providership” in their CME materials?

The ACCME expects accredited providers to discontinue the use of the term “sponsor” (e.g., jointly sponsored, joint sponsorship, directly sponsored, direct sponsorship) for new materials published after January 1, 2015. Please note that this change in terminology applies to accreditation statements for directly and jointly provided activities, as well as other materials.

What impact will the 2014 changes to simplify ACCME’s accreditation requirements and processes have on the accreditation process for accredited CME providers?

Effective February 2014, no organization will be evaluated for compliance for ACCME requirements or policies that were removed as a result of the ACCME’s 2014 simplification of its accreditation requirements and processes. This applies to organizations regardless of what stage of the accreditation process they are in. Specific scenarios are summarized below:

As a CME provider accredited by an ACCME-Recognized Accreditor (state/territory medical society), does the ACCME’s February 2014 simplifications of its accreditation requirements and processes apply to my organization?

Yes. The February 2014 changes to ACCME’s accreditation requirements and processes apply to all accredited providers within the ACCME accreditation system. ACCME Recognized Accreditors are responsible for implementing these changes for intrastate providers. Please check with your accreditor about the implementation process.

What is the FDA requirement for long-term evaluations of the prescriber training component of the ER/LA Opioid Analgesics REMS?

The FDA has required long-term evaluations of the ER/LA prescribers who complete REMS-compliant CE activities. Specifically, the FDA is requiring the evaluation of knowledge retention and practice change in ER/LA opioid prescribers 6-12 months after completing the REMS-compliant CE activity. The long-term evaluations will be separate and different from any post-tests that might be conducted by accredited CE providers immediately after all REMS-compliant CE activities.

 

How is the continuing education community addressing prescription drug abuse?

The CE community addresses prescription drug abuse in many ways. One way is by developing and presenting education that is explicitly part of the RPC-funded ER/LA Opioid Analgesics REMS that meets all the specific REMS requirements.  Another way is through the activities offered by accredited CE providers on a wide range of important topics to educate healthcare professionals about  prescription drug safety, and drug abuse prevention, intervention, and treatment.

What is an FDA Risk Evaluation and Mitigation Strategy?

The Food and Drug Administration Amendments Act of 2007 gave the FDA the authority to require manufacturers of drugs and biological products to put in place special programs if the FDA determines that safety measures are needed beyond the professional labeling to ensure that the benefits of products outweigh their risks.  The manufacturers then implement FDA-monitored actions to address those risks.  The FDA calls each of these a Risk Evaluation and Mitigation

Can providers be required by potential commercial supporters to share the list of expected authors or speakers with commercial supporters, during the process of applying for an educational grant?

No. The ACCME cannot control what a commercial interest asks of an accredited provider but there is no CME reason for the provider to share the names of speakers/authors with commercial supporters.  An accredited provider that submits to the requirement of a commercial supporter to supply the names of speakers and authors could be participating in a process whereby the commercial supporter is controlling the selection of speakers and authors in accredited CME.

Is there a fee for accredited providers to participate in the REMS-compliant CME data collection and auditing process?

In order to provide an equitable process for all accredited CME providers within the ACCME system, the ACCME is assessing a per activity fee of $1,500 from accredited CME providers that receive commercial support from the REMS Program Companies (RPC) to develop ER/LA Opioid Analgesic REMS-compliant CE activities; this fee will enable ACCME to develop, implement, and maintain the systems required to support the data collection, reporting, and auditing process stipulated by the FDA.

Are there new ACCME requirements related to ER/LA Opioid Analgesics REMS CME activities?

No. The ACCME does not require accredited providers to offer REMS-compliant or REMS-related CE activities. There are no new or special accreditation requirements for accredited providers within the ACCME system that provide REMS activities. The REMS CE reporting requirements are mandated by the Food and Drug Administration (FDA) and the REMS Program Companies (RPC); they are not ACCME requirements.

What information do accredited providers need to collect and submit into PARS in order to participate in the ER/LA Opioid Analgesics REMS data collection process?

The ACCME has modified PARS to accept the data mandated by the FDA, including how many REMS CME activity participants prescribed ER/LA opioids within the last year, and a breakdown of these individuals by profession. Accredited CME providers may also submit information on the number of participants that were registered with the DEA to prescribe Schedule 2 and 3 drugs, as well as participants by practice type (primary care, pain specialist, non-pain specialist).

How is the ACCME participating in the data collection and auditing process for the ER/LA Opioid Analgesics REMS?

As a service to the CME community and to the FDA, the ACCME has agreed to contribute to fulfilling the data collection and auditing requirements for the ER/LA Opioid Analgesics REMS. The ACCME has modified its Program and Activity Reporting System (PARS) to enable accredited providers to submit information about REMS CME activities and has a process for generating reports containing data about those activities.

Do I need to obtain disclosure of relevant financial relationships directly from the spouse or partner of a person who is in a position to control the content of a CME activity? (Standard for Commercial Support 2.1)

No. ACCME considers relationships of the person involved in the CME activity to include financial relationships of a spouse or partner.  The ACCME expects that providers will communicate to everyone who is in a position to control of content of an educational activity that the individual’s disclosure of relevant financial relationships must include:

What are examples of those in control of content as described in Standard for Commercial Support (SCS) 2.1?

SCS 2.1 requires that the accredited provider “must be able to show that everyone who is in a position to control the content of an education activity has disclosed all relevant financial relationships with any commercial interest to the provider.”  If someone in connection to the activity has the opportunity to affect the content, they are “in control of content.”  Those individuals in a position to control the content of an e

What is the difference between significant financial relationships and relevant financial relationships?

First it is important to understand how the ACCME defines a financial relationship. Financial relationships are those relationships in which the individual benefits by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit.

How do I update my organization's contact information in PARS?

All of the users associated with your organization in PARS have the ability to edit organizational contact information in PARS on the “Organization Profile” tab in PARS.  Contact information for individual users may be edited on the “User Management” tab.

Who is authorized to ask questions and receive information about my accredited organization?

ACCME recognizes all individuals that are associated with your organization in the ACCME’s Program and Activity Reporting System (“PARS”) as authorized representatives who may ask questions and receive information related to your organization’s ACCME accreditation. This includes users that are assigned to the role(s) of Primary Contact, Billing Contact, and Chief Executive Officer, as well as those listed as “Other Users” in PARS. 

How should an accredited provider manage and report funds received from commercial interests to reserve space for a CME activity that is held in conjunction with another organization’s meeting?

All funds that originate from ACCME-defined commercial interests and are paid to reserve space to hold accredited CME activities (sometimes called satellite symposia) in conjunction with other organizations’ meetings are considered commercial support. As with all commercial support, these funds must be paid directly to the accredited provider responsible for the activity or to a designated nonaccredited joint provider.

Is it acceptable for an accredited provider to include product-specific content in an activity based on the FDA ER/LA Opioid Analgesics REMS blueprint?

Yes. There is no ACCME prohibition against including product-specific content in accredited CME. Accredited providers can develop and distribute product-specific content for activities based on the FDA blueprint for the Extended-Release and Long-Acting (ER/LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) because the blueprint was developed and issued independent of the control of any ACCME-defined commercial interest. As with any CME activity, accredited providers must comply with the ACCME accreditation requirements.

Does the ACCME information about the ER/LA Opioid Analgesics REMS apply to all REMS?

No. The ACCME information applies only to the ER/LA Opioid Analgesics REMS. The ACCME appreciates that the FDA recognizes the value of accredited  education and believes that accredited CME should be considered as a strategic asset to all those trying to improve drug safety. Since 2009, the ACCME has supported the role of accredited CME as a strategic asset to REMS FDA-approved products, provided the proper controls are in place to ensure independence. The ACCME will be ready to respond if the government calls on accredited CE to support implementation of other REMS.
 

What is the ACCME's role in the ER/LA opioid Analgesics REMS?

The ACCME views the FDA ER/LA Opioid Analgesic  REMS as an important initiative for addressing  a critical public health and patient safety concern. The ACCME believes that accredited CME can be an important factor in the success of this REMS and all REMS that involve continuing professional education.

What is the role of accredited continuing education in the FDA ER/LA Opioid Analgesics REMS?

In the Extended-Release and Long-Acting Opioid Analgesics REMS, one of the elements to assure safe use is an education program for prescribers about the risks of opioid medications as well as safe prescribing and safe use practices. The ER/LA Opioid Analgesics REMS requires the manufacturers to provide commercial support to accredited CME so that it is available free of charge or at nominal cost to prescribers. However, the participation of accredited providers is completely voluntary – as is the participation of prescribers in REMS education.

What is the FDA REMS for Extended-Release and Long-Acting Opioids?

The FDA delivered its Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting (ER/LA) opioid analgesics to the manufacturers in 2012.  According to the FDA news release the REMS "is designed to ensure that healthcare professionals are trained in how to properly prescribe these medicines and how to instruct their patients about using them safely."  It has two components: a medication guide and elements to assure safe use.
 

Is it acceptable to provide a link within an Internet CME activity that participants can click on, if they choose, in order to access 'disclosure information' for the activity?

No. As has always been the case, the required information specified in the ACCME Standards for Commercial SupportSM: Standards to Ensure Independence (SCS), Standard 6 related to disclosure to learners of relevant financial relationship(s) must be transmitted, not only made accessible, to the learner prior to the learner engaging in the CME activity. The learner should be made to pass through this information prior to engaging in the CME activity.

In an electronic CME activity, can we provide the disclosure information that is required in the Standards for Commercial Support by SCS6 via a link which participants can click on, if they choose?

No. For CME activities in which the learner participates electronically (e.g., via the Internet), all required ACCME information specified in Standard for Commercial Support 6: Disclosures Relevant to Potential Commercial Bias must be transmitted to the learner prior to the learner beginning the CME activity.

What do I need to know about the "Attestation" section of the Program Summary tab?

Each year, the ACCME collects, summarizes, and publishes information about the CME enterprise on its website as a service to accredited providers, other members of the CME community, and the public via the ACCME’s Program and Activity Reporting System (PARS). At the conclusion of each Reporting Year, a provider is required to submit information about their activities that took place during the year as well as financial data about their overall CME Program.

Are there differences in batch upload templates based on the year that our CME activities occurred?

Yes.  Since providers began using PARS, ACCME has made modifications to the batch upload templates to reflect changes to the PARS system.  Templates are clearly identified by Reporting Year, and each template has detailed instructions that accompany it.   When you click on the Batch Upload Activities button in PARS to begin the batch upload process, you are prompted to indicate the Reporting Year for which you are uploading activities.  Be careful to select the correct year so that your batch upload can be successfully completed.

 

How does the ACCME define an internet searching and learning activity?

Internet searching and learning activities is based on a learner identifying a problem in practice and then accessing content in search for an answer from sources on the Internet that are facilitated by a provider. For the purpose of ACCME data collection, the ACCME includes AMA-defined point of care CME as a form of internet searching and learning.

How does the ACCME define a performance improvement activity?

Performance improvement activities are based on a learner’s participation in a project established and/or guided by a provider in which a physician identifies an educational need through a measure of his/her performance in practice, engages in educational experiences to meet the need, integrates learning into patient care and then re-evaluates his/her performance.

How does the ACCME define a journal-based CME activity?

A journal-based CME activity includes the reading of an article (or adapted formats for special needs), a provider stipulated/learner directed phase (that may include reflection, discussion, or debate about the material contained in the article(s)) and a requirement for the completion by the learner of a pre-determined set of questions or tasks relating to the content of the material as part of the learning process.

How does the ACCME define an internet enduring material activity?

An internet enduring material activity is available when the physician participant chooses to complete it.  It is “enduring,” meaning that there is not just one time on one day to participate in it.  Rather, the participant determines when he/she participates.  (Examples:  online interactive educational module, recorded presentation, podcast).

How does the ACCME define an enduring material activity?

An enduring material is a printed, recorded, or computer-presented CME activity that may be used over time at various locations and which, in itself, constitutes a planned activity. In an enduring material the provider creates the content.

How does the ACCME define a course?

A course is a live CME activity where the learner participates in person. A course is planned as an individual event. Examples: annual meeting, conference, seminar.

How does the ACCME define a learning from teaching activity?

Learning from teaching is a descriptive label for a type of CME activity. (The identification of activity types by the ACCME serves to allow the ACCME to report data and information on the range of educational formats offered by the national CME enterprise. This helps provide an accurate description of the CME enterprise and dispels the myth that accredited CME is mostly lecture, or didactic, in format.) The ACCME does not have special requirements for this activity type.

What's the difference between "knowledge," "competence," "performance" and "patient outcomes"?

The ACCME requires accredited providers to understand the issues with knowledge or competence or performance that underlie a professional practice gap. Problems with knowledge, competence or performance that underlie a professional practice gap — and design an educational activity to intervene — and to design and to measure — in terms of changes in competence, performance or patient outcomes. The patient outcome or the outcome is like the professional practice gap, those are analogous.

Can you provide me with some solid examples of the type of data that would be acceptable in meeting Criterion 12, "The provider gathers data or information and conducts a program-based analysis on the degree to which the CME mission of the provider has been met through the conduct of CME activities/educational interventions."

Let us say a CME provider set its mission so that the expected result of its program of CME was to change competence and was, "To enable learners to develop strategies for the identification of patients with drug addiction."

Examples of a sample of the type of data that would be acceptable in meeting Criterion 12 would be:

"When we started, none of our learners could ask the right screening questions, did ask the right screening questions, or identified a patient with drug dependence in their practice." 

What are some examples of non-educational strategies as mentioned in Criterion 17?

Examples of a "non-educational strategy to enhance or facilitate change as an adjunct to activities or educational interventions" would be, 1) implementing a mechanism to send reminders to participants following CME activities (e.g., "Don't forget to..." or "Have you incorporated...?"), or 2) working with others to facilitate a peer to peer feedback system to reinforce new practices, or 3) incorporating new questions about the new practices into patient satisfaction questionnaires.

What resources does the ACCME have in place to assist providers (and other stakeholders) with meeting the ACCME's standards for continuing medical education?

The ACCME is committed to ensuring that accredited providers have tools and resources to help them meet ACCME policies and standards. Educational opportunities include resources available through the ACCME website (www.accme.org) and training-focused workshops and other meetings. For more information, visit the Education section on our website.

What type of training does the ACCME offer to ACCME accredited providers to assist them with meeting the expectations of the ACCME 2006 Accreditation Criteria?

The ACCME delivers a "CME as a Bridge to Quality" Accreditation Workshop two to three times each year to provide training and support regarding the expectations of the ACCME Accreditation Criteria. To see dates for upcoming workshops or to register, please visit this page.

In addition, the ACCME also provides educational resources and tools via the Education section of the ACCME website.

Does the ACCME require hospital-based CME programs to become part of their organization's Quality Improvement Department?

No. Criterion 21 requires that the provider, "participates within a institutional or system framework for quality improvement", but does not specify the manner in which this is achieved. Criterion 21 is required to achieve Accreditation with Commendation (Level 3), however noncompliance with Criterion 21 is not held against providers seeking Full Accreditation (Level 2). For examples of provider practices that achieve compliance with Criterion 21, see the ACCME's Provider Examples of Compliance and Noncompliance.

Do I have to document compliance with all criteria for each activity?

No, you do not. Some Criteria address your overall CME program, while others relate to CME activities. For each CME activity, you need to demonstrate compliance with Criteria 2 - 6, which address educational planning and delivery. In addition, you need to demonstrate compliance with the ACCME Standards for Commercial Support SM (Criteria 7 - 10). Criterion 11 requires that providers evaluate changes in learners' competence or performance or patient outcomes, in order to be able to analyze those changes achieved as a result of the overall program's activities.

In Criterion 2, what is meant by "professional practice gap?"

This is an ACCME adaptation of an Agency for Healthcare Research and Quality (AHRQ) definition of a gap in the quality of patient care where the gap is "the difference between health care processes or outcomes observed in practice, and those potentially achievable on the basis of current professional knowledge."

Criteria 1 and 3 refer to "changes in competence, performance, or patient outcomes" but Criterion 2 refers to educational need in terms of "knowledge, competence, or performance." Can CME providers offer activities that are designed to change knowledge?

Yes. CME providers can offer activities designed to change knowledge. The emphasis now is on the CME provider knowing the "educational needs that underlie the professional practice gaps of their own learners." ACCME believes that the path to closing the gap will be through modifications to one, or more, of physicians' knowledge, competence, or performance. ACCME expects that CME providers and learners will analyze the gaps in order to understand the causes so as to determine what might be the best or most appropriate educational intervention.

With respect to Criterion 2, must educational need for each activity be grounded in actual data that has been collected and analyzed?

Criterion 2 requires that the educational needs that underlie the professional practice gaps of learners be incorporated into the CME activities. However, the CME provider does not have to collect that needs data. There are many, many sources of needs data that relate to professional practice gaps. Determining if that data is relevant to the actual learners is a task for the CME provider. The ACCME's announcement of the Updated Criteria included some references that might be a place for the CME provider to start.

Must the source of an educational need be grounded in one of the American Board of Medical Specialties' (ABMS) core competencies?

Needs assessment is about understanding the basis for a 'professional practice gap' - in terms of an underlying problem with knowledge, competence or performance-in-practice. A provider may want to further understand the underlying problem in the context of one or more of the competencies - so an educational need may be grounded in one or more of ABMS' core competencies. There are other competencies that have been promulgated that might be useful for the CME provider to consider, e.g., the IOM competencies, specialty - specific competencies.

Does CME have to give "equal time" to all modalities of therapy (e.g., surgical vs. medical)? Does CME have to give "equal time" to all formulations of a drug or all products in a class of products?

CME must be free of commercial bias. CME must not promote products or services. CME must promote improvements in healthcare. A "balanced view" means that recommendations or emphasis must fairly represent, and be based on, a reasonable and valid interpretation of the information available on the subject (e.g., "On balance the data support the following..."). A "balanced view of therapeutic options" also means that no single product or service is over represented in the education activity when other equal but competing products or services are available for inclusion.

If we have taken appropriate steps to resolve conflicts of interest what is there left to disclose?

Informed learners are the final safeguards in assuring that a CME activity is independent from commercial influence. Regarding personal conflicts of interest, CME providers are to have in place mechanisms to identify and resolve conflicts of interest. While these mechanisms should greatly reduce the potential for conflicts of interest to affect CME content, a potential for influence remains. Disclosing to learners the relevant financial relationships that were present and resolved assists learners in assessing the potential for bias in information that is presented.

In SCS 6.1, the ACCME says that included in disclosure to the learners should be the nature of the relationship the person has with each commercial interest. What does the ACCME mean by nature of the relationship?

The nature of the relationship means the role they play or service they provide in exchange for some form of compensation (e.g., independent contractor including contracted research, consulting, promotional speaking and teaching, membership on advisory committees or review panels and board membership). ACCME has not set a minimum dollar amount for relationships to be relevant.

Is disclosure of commercial support different than disclosure of financial relationships?

Yes. Commercial support is financial, or in-kind, contributions given by a commercial interest, which is used to pay all or part of the costs of a CME activity. This is money given to the provider to support the activity. In contrast, financial relationships are between an individual being asked to assume a role controlling content of the CME activity and a commercial interest and occur outside of the CME activity (e.g. a teacher or author of participating in a CME activity is paid by a commercial interest to speak).

Where can advertising appear related to educational events?

ACCME insists on the separation of education from all promotional activities, materials and messages. Many providers create a print or text based document that goes along with an activity and provides information that is supplementary to the education content - like reproductions of slides, graphics or other handouts. These documents, in print or electronic, are an integral part of the education and as such cannot have any advertising, corporate logo, trade name or a product-group message of an ACCME-defined commercial interest associated with them.

Our program book has abstracts in it but we give no CME credit for the abstracts - there is no problem having advertising in the program book, correct?

It would depend on what the program book, with abstracts, is used for in relation to the CME activity. If the abstracts are referenced during the activity or serve as a component of the content, then there can be no advertising in the program book. If the abstracts are not referenced as part of the CME content, and appear in the program book with all other logistical information about the activity, then there can be advertising.

Since the updated SCS do not mention off-label usage, does that mean that disclosure for off-label uses is no longer required or that discussion of off-label uses is not allowed in a CME activity? (SCS 5.1)

Discussion of off-label uses are certainly allowed in CME activities. However, providers are no longer required to have a mechanism in place to ensure that off-label or investigational uses are disclosed as such. The ACCME adopted content validation statements in 2002 that are expectations of providers with regard to any recommendations for clinical care.

What kind of documentation of commercial support is expected?

ACCME expects to be able to review income and expense statements for all CME activities. These statements must reflect:

Significant sources of income: Including income from commercial support, advertising and exhibit fees, tuition and registration fees, internal budget allocations and any other source that represents greater than 20% of total income.

Is it acceptable to say, "In exchange for $5,000 of commercial support and $5,000 in exhibit fees, we will produce the CME activity and as a commercial supporter you will get an acknowledgment and a 4 x 4 sq ft booth in the exhibit hall. Can we itemize both the commercial support and the promotional fees in the same written agreement?

No, in this scenario the commercial interest is giving commercial support and buying promotional and sales opportunities. The commercial interest should buy advertising and promotion opportunities with resources designated for that purpose. If an agreement for advertising or promotion is struck between the two parties it must be outside the written agreement for commercial support described in Standard 3 of the SCS.

Does SCS 4.2 represent a change for enduring materials?

This is a more detailed description of the requirements that must be followed if there is advertising in enduring materials. There can be advertising before and after the CME content of an enduring material but those advertisements cannot be related to the content of the CME and cannot have been paid for by the commercial supporter.

What does ACCME mean by space or place related to SCS 4.2?

Twenty years ago, most CME occurred in a lecture hall. Now, learning activities occur in many different environments including electronic media, and ACCME intends that all of these places and spaces of CME activity need to be protected from encroachment by advertising, sales or promotional activity.

Can providers pay some of the expenses of people who are both faculty and learners?

Yes - but CME providers need to be sure that these people have bona fide teaching roles. In the United States, physician learners are not to be given compensation or reimbursement for attending CME activities (see Opinion 8.061 of the Council on Ethical and Judicial Affairs of the American Medical Association). It is unacceptable for anyone other than the Provider, or its agents, to receive direct financial benefit from commercial support.

What does the ACCME mean by "control" in its expectation that a provider make certain decisions free from the "control" of a commercial interest?

The ACCME expects that the provider makes decisions related to the planning and implementation of CME activities without being directed or influenced by commercial interests.

A provider will be found in Noncompliance with SCS 1.1 and SCS 3.2 if the provider enters into a commercial support agreement where the commercial supporter specifies the manner in which the provider will fulfill the requirements of the ACCME's Elements, Policies and Standards. (Applicable to all electronically, digitally or manually signed written agreements executed after January 1, 2008.)

If disclosure information cannot be analyzed in a timely fashion, is it appropriate for the activity or presentation to go on without formal CME credit?

ACCME has never recommended withholding CME credit at the last minute as an alternative to producing CME that is in compliance with accreditation requirements. It does not seem fair to the physician learners. Assuming that in this scenario there is financial relationship information to disclose to the learners, a mechanism to resolve conflicts of interest could still be put in place.

Can faculty take an active role in the provider's mechanism(s) to resolve conflicts of interest?

Yes . Resolving conflicts of interest means individuals taking explicit actions prior to the educational activity to create CME content that is valid and free of commercial bias -- even in the presence of relevant financial relationships. In the construct of the current CME system, the development and presentation of CME content is most often the responsibility of teachers/authors. Therefore, the ACCME considers teachers/authors to be a part of the accredited provider.

We use "peer review" as our mechanism to resolve conflicts of interest. We read the content of each presentation, looking for commercial bias and content that is not supported by evidence. Does this resolve conflict of interest?

No . "We read the content of each presentation, looking for commercial bias and content that is not supported by evidence" is a mechanism to identify commercial bias and invalid content but it does nothing to change the content so that the bias is gone and the content is valid. As described, it is a monitoring or screening process. If used before the activity it is a screening process -- and action needs to be taken to revise the content if commercial bias or invalid content are identified.

What is commercial support?

Commercial support is financial, or in-kind, contributions given by a commercial interest, which is used to pay all or part of the costs of a CME activity.

Can a commercial supporter direct the content of CME?

No. The provider must ensure that the content of the CME truly remains beyond the control of the commercial supporter. The process to develop the CME must be independent of the commercial interest. Providers must not allow commercial supporters to directly (SCS 1.1) or indirectly (SCS 3.2) control the content of CME.

Can a provider leave it up to an individual who controls content to determine if his/her relevant financial relationship creates a conflict of interest that needs to be resolved?

No. The provider cannot delegate the responsibility for resolving the conflict of interest to the person with the conflict of interest. However, an individual who controls CME content can be involved in the mechanism by being expected to take specific actions to resolve his/her conflict (ex: removing bias, using an evidence-based approach) under the supervision of the provider.

What if, based on the disclosure information that we collect, we believe there is a conflict of interest? Does ACCME have any other examples of mechanisms for resolving conflict of interests that go beyond the five examples in "Identifying and Resolving Conflicts of Interest in Continuing Medical Education?"

Yes. Please keep in mind that these are only suggested mechanisms. Each provider will want to design and adopt a mechanism that works best for its structure and type of activities. The intent of the Updated Standards is that any content about products is aligned with the best interest of the physician learners and their patients.

Is it necessary to collect disclosure information on relevant financial relationships from a speaker each and every time the speaker participates in a CME activity?

No. It is not necessary to collect disclosure information on relevant financial relationships from a speaker, planner, or author each and every time that individual has control over the content of a CME activity. SCS Element 2.1 requires that the provider be able to show the ACCME that everyone who has control of CME content has disclosed all relevant financial relationships with any commercial interest to the provider.

When do relationships create "conflicts of interest?"

The ACCME considers financial relationships to create actual conflicts of interest in CME when individuals have both a financial relationship with a commercial interest and the opportunity to affect the content of CME about the products or services of that commercial interest.

Where is the "conflict?"

In accredited CME, when an individual's interests are aligned with those of a commercial interest, the interests of the provider are in "conflict" with the interests of the public. The interests of the people controlling CME must always be aligned with what is in the best interests of the public.

If at the first planning meeting for a CME activity, all committee members are asked to disclose, and each member responds that he/she has nothing to disclose (or disclose something), and this information is reflected in the minutes of the meeting - is that enough documentation that disclosure was sought?

Yes. That documentation would verify that the first step of a mechanism for identifying conflicts of interest is in place. That would document for ACCME that the Provider knew the relevant financial relationships of the Committee members. However, keep in mind that the provider would need to be able to show that there was an assessment of whether or not the information disclosed caused a conflict of interest and if so, what was done to resolve the conflict.

Why will the ACCME not allow commercial interests to act as joint providers? (SCS 1.2)

Joint providers are expected to routinely have a role in making decisions about the elements of the planning process specified in SCS 1.1. Since these decisions must be "made free of the control of a commercial interest" as per SCS 1.1, the joint provider cannot be a commercial interest. For further information on this topic, please click here to view the ACCME policy on joint providership.

How did the change in the definition of a commercial interest announced in August 2007 affect already accredited providers that might be owned by a commercial interest?

As of August 2007 the ACCME defined a commercial interest as "any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients." The ACCME worked individually with accredited providers that were affected by this definition as they transitioned to an independent corporate structure that is acceptable in the context of the ACCME's Standards for Commercial Support.

What is an example of a corporate structure that meets the ACCME's requirements for independence?

The ACCME offered several alternatives for corporate restructuring that met its requirements. For example, the ACCME determined that an accredited CME provider can have a sister corporation that is a commercial interest, as well as a parent corporation that is not a commercial interest, as long as each corporation is a separate legal entity and there are proper firewalls in place. The corporation that is the CME provider:

Can an accredited provider ask a commercial interest for suggestions related to topics or speakers for CME?

No. There is no reason for the CME provider to request suggestions for speakers or topics from commercial interests -- since it is unacceptable to act upon their suggestions. CME providers can receive commercial support from industry.  CME providers cannot receive guidance, either nuanced or direct, on the content of the activity or on who should deliver that content. If the provider implements the suggestions of the commercial interest then this creates the situation where the ind

Can accredited CME include the oral (e.g., presentations) or written reporting (e.g., abstracts) of "scientific research" conducted by ACCME-defined commercial interests that is reported by employees of those commercial interests?

Yes, as long as the CME activity complies with the ACCME's Accreditation Criteria, including the ACCME® Standards for Commercial SupportSM. It is understood and accepted that industry conducts its own research and that industry partners, as a collaborator, in research.

What am I required to put on an activity brochure?

For brochures, the ACCME does not have any rules or requirements for name placement, brochure content, cover design, interior layout, font size, or formatting. Brochure design and associated content are left to the provider's discretion. The accredited provider has the right to set criteria for its own standards in relation to its CME publications (both directly and jointly provided). The only ACCME requirement is that the correct accreditation statement be used somewhere within the brochure.

Does the ACCME accredit individual activities?

No. The ACCME accredits organizations that produce CME activities. The accreditation process includes the review of CME activities for the demonstration of compliance with the ACCME's requirements. For more information, see ACCME's description of the accreditation process for first-time applicants.

Does the ACCME share CME best practices, or examples, with CME providers?

Yes. The ACCME publishes a library of Examples of Compliance and Noncompliance gathered during the course of the accreditation review process. Additionally, the Education section of the ACCME website provides a number of multimedia vignettes in which ACCME staff, accredited providers, and system stakeholders discuss practical issues regarding the implementation of the ACCME Criteria and policies. Lastly, the ACCME offers a number of educational workshops focused on training that is informed by provider best-practices.

What should a provider do if an Internet CME activity from the current accreditation term is selected for documentation review, but this particular Internet CME activity has been "retired" and is no longer available on the Internet?

This activity still needs to be available for review by the ACCME - even if it has been "retired." When an Internet CME activity is no longer available online, the accredited provider may submit the internet activity saved to CD ROM or provide access to the activity on an archived web site.

Does the ACCME require me to issue credit certificates to physician participants?

No. The ACCME has no requirements about issuing credit and/or certificates. All credit-related questions should be referred to the organization that manages the credit. For example, the American Medical Association manages AMA PRA Category 1 Credit, and the American Academy of Family Physicians manages its own credit system.

As an accredited provider, we know that we need to provide accommodations to CME activity participants who request them under the Americans with Disabilities Act (ADA). Can you tell us more about the ACCME's expectations with respect to the ADA?

The ACCME expects that providers will have policies or procedures in place to accommodate learners with disabilities. The ACCME's policy in this regard states, "The provider must operate the business and management policies and procedures of its CME program (as they relate to human resources, financial affairs and legal obligations), so that its obligations and commitments are met."

Will the ACCME make public the identity of providers that are the subject of complaints?

No. The complaints process and findings are kept confidential by the ACCME, with the exception of the ACCME's response to a lawful subpoena or other legal process. The ACCME does reserve the right to make public blinded examples and summaries from the complaints process for the purpose of educating providers and other stakeholders. This public information will not identify providers.

What content is acceptable for CME?

ACCME-accredited providers must provide CME that contains content which falls within the definition of CME. The content of such CME must not promote recommendations, treatment or manners of practicing medicine that are known to have risks or dangers that outweigh the benefits, or are known to be ineffective in the treatment of patients. Note that an organization whose program of CME is devoted to advocacy of unscientific modalities of diagnosis or therapy is not eligible to apply for ACCME accreditation.

What is the ACCME's process for accepting and handling complaints or inquiries about accredited providers' CME practices?

The ACCME has a multitiered accreditation process for evaluating CME providers’ compliance with the ACCME’s requirements. As an additional safeguard, the ACCME has a Process for Handling Complaints Regarding ACCME-Accredited Providers, which it uses to respond to complaints from the public and the CME community about ACCME-accredited providers’ compliance with accreditation requirements.

What is the significance of "Reporting Year?"

Annually, ACCME aggregates the activity data that is reported by providers and publishes an Annual Report that provides information to the CME community about the size and scope of the CME enterprise.  The “Reporting Year” tells ACCME in which Annual Report the activity belongs.  Most providers operate on a calendar year basis, and for these providers the Reporting Year is equivalent to the year of the Activity Date (For instance, Activity Date = September 1, 2010, and Reporting Year = 2010).

What is the difference between direct providership and joint providership of CME activities?

A directly provided activity is one that is planned, implemented and evaluated by the accredited provider.  Include co-provided activities (provided by two accredited providers) in this category if you are the accredited provider awarding the credit.  In contrast, a jointly provided activity is one that is planned, implemented and evaluated by the accredited provider and a non-accredited entity.

Related link: ACCME's Poicy on Joint Providership

 

What type of information is ACCME looking for in the "Description of Content" field?

“Description of Content” is an optional field for a description of the information and topics that were discussed during the CME activity.  There is no specified format for this field, although it is limited to 2500 characters.  If your organization produced an abstract for the activity, we encourage you to copy and paste it into the Content field.  If you did not produce an abstract, you may include the written objectives of the activity, or simply describe the content in your own words.  In the future, this information may

Can you explain how ACCME defines other learners (nonphysician participants)?

Nonphysicians are called “other learners.” This category includes activity participants other than MDs and DOs. Beginning with the 2015 reporting year, residents are no longer included in this category and are instead counted as physician participants. The terminology change has been made in response to feedback from the CME community that “other learners” is a more appropriate term for describing the range of learners.

Related content:

How does the ACCME define physician participants?

How do we report in-kind support?

In March 2011, the ACCME modified the requirement for reporting in-kind commercial support, in response to feedback from accredited providers. Below is a description of how to report in-kind commercial support via the Program and Activity Reporting System (PARS) for activities taking place in 2011 and beyond, as well as for activities that took place in or before 2010.

I entered all of the required activity information into the form, but I don't see it on the Activities page now. Where did it go?

By default, the Activities page of PARS displays “open” activities that occur during the current Reporting Year.  If you enter all required activity information, but no longer see the activity listed in the default view, first make sure that the “Reporting Year” is set to the appropriate year for the activity, and then click on the “closed” tab on the Activities page.  Activities that contain all required information are considered “closed.”

Are state accredited providers required to enter information into PARS?

No. Some Recognized State Medical Societies have elected to use PARS for the collection of their providers' CME program and activity information instead of the SMS Online Provider System.  Intrastate providers should consult with their state accreditor if they are unsure which system to use.

What is the purpose of PARS?

The primary purpose of PARS is to provide a centralized system for the ACCME’s collection and management of activity and program data from its accredited CME providers. PARS will help the ACCME and providers demonstrate the size, scope and value of the CME enterprise.

Does PARS replace the Reaccreditation Activity Lists and Annual Report?

Yes.  PARS replaces the Excel spreadsheets ACCME used to collect activity data during the reaccreditation process, as well as the online Annual Reporting System that ACCME accredited providers used to submit their ACCME Annual Reports. PARS streamlines these two data reporting mechanisms into one central location.

Who can use PARS?

Individuals who are designated as a Primary Contact, Billing Contact and/or CEO of an organization accredited by the ACCME or a recognized state medical society that has elected to use PARS may access PARS with a unique login ID and password.

When, and how frequently, do I need to enter data into PARS?

Providers may determine when and with how much frequency to enter their activity data.  ACCME encourages providers to begin inputting data as soon as possible.  You can enter basic information about an activity before it has taken place and complet the entry after the activity occurs.  You must enter all of your organization's program and activity data for a completed Reporting Year and complete the Attestation by the last business day of the following March to allow for the calculation of the ACCME A

Can I generate reports based on information that I input into PARS?

Yes.  Providers have the ability to download a file that contains all of their activity data by clicking on the "Download All Activities" link on the Activities tab in PARS.   By clicking on this link, the data that your organization has reported will be downloaded into a .csv file, which you can then save as a .xls or other spreadsheet file format for easy reference and analysis.

What are the different ways I can input data into PARS, and which option is right for my organization?

  1. Web-based Interface - By clicking “Add an Activity” on the  Activities page, you can enter data about activities one at a time.  The web-based interface is a good option for organizations that only provide a moderate number of activities throughout the year, or do not already have a CME tracking system of their own.

Providers also have two options for uploading data in batches (you can click on the link below to learn more about each of these options)

What is a tab-delimited batch upload?

The tab-delimited batch upload enables providers to export multiple activity records at one time into PARS.  The tab-delimited batch upload process originates with the use of an MS Excel template which closely mirrors the CME Activity List used previously by ACCME accredited providers to report activities for reaccreditation purposes.

What is an XML file upload?

XML File Export:  XML stands for eXtensible Markup Language, a Web standard that makes it easier for computer systems to exchange data over the Internet.  In order to collect information in a manner that is consistent with the data communications standards being adopted by medical education content providers, PARS includes a data upload tool that accepts XML files formatted to conform with the Medical Education Metrics (MEMS) XML standard created by Medbiquitous.  Providers that have CME activity tracking systems that support exports to XML files may wish to explore this op

What is the difference between "open" and "closed" activities?

An important concept in PARS is that of “open” and “closed” activities.  Open activities are those that have a minimum set of data entered for them:  specifically, activity name, activity type, activity date, and, if applicable, location.  Once these data about an activity are entered, the activity is “open”, and is saved to the database.    Closed activities are those activities for which all required information has been entered.  For example, in order for an activity to be considered “closed”, a provider must enter data about the hours of instruction, physician and non-physician particip

What is meant by "Income from Other Sources"?

 

For reporting years up to and including 2014

“Income from Other Sources” is a field in the Program Summary tab of the ACCME’s Program and Activity Reporting System (PARS) that is required for reporting years up to and including 2014:

What is the Program Summary?

The Program Summary is a summary of financial data attributable to your entire CME Program for the year. For Reporting Years up to and including 2014, the Program Summary reflects two kinds of data:

How do I report Manuscript Review CME in PARS?

When you report Manuscript Review CME in PARS, report each journal for which the manuscript is being reviewed as an activity regardless of how many manuscripts there are and regardless of how many persons have reviewed manuscripts as CME.  For hours of instruction, specify the amount of time you believe a learner would take to complete the Manuscript Review CME activity.  The number of participants should reflect the total number of learners engaged in reviewing manuscripts as CME. 

How do I report Performance Improvement CME in PARS?

When you report Performance Improvement CME in PARS, count each learning project as one Performance Improvement CME activity, regardless of whether or not it is created for an individual physician, or group of physicians. For hours of instruction, specify the amount of time you believe a learner would take to complete the Performance Improvement CME activity. The number of participants should equal the total number of learners who participated in the learning project. 

How do I report Internet Searching and Learning CME in PARS?

When you report Internet Searching and Learning CME in PARS, aggregate and report all your data for Internet Searching and Learning CME for all learners into one activity. For hours of instruction, specify the amount of time you believe a learner would take to complete their Internet Searching and Learning CME activity. The number of participants should equal to the total number of persons who participated in Internet Searching and Learning as a CME activity.

How do I report Learning from Teaching CME in PARS?

When you report Learning from Teaching CME in PARS, aggregate your data for Learning from Teaching CME for all learners into one activity. For hours of instruction, specify the amount of time you believe a learner would take to complete their Learning from Teaching CME activity. The number of participants should equal the number of individuals who participated in this CME activity.

How do I copy activities in PARS?

If you provide the same activity in multiple locations (e.g., update course) or provide the same activity year after year (e.g., annual meeting), you can save time entering data about these activities by using the copy function in PARS. The copy function allows providers to select an existing activity and create a new activity that contains the same data for the following fields:

 

  • Activity Type

  • Activity Sub-category (if applicable)

  • Activity Title

How do I delete more than one activity at a time?

If you need to delete more than one activity at a time from PARS, you may do so by visiting the View Activities screen and selecting the applicable Reporting Year. Expand the list of either closed and/or open activities, and click the Select for Deletion checkbox next to each activity that you want to delete. When you have selected the activities you want to delete from both the open and closed lists, click the Delete Selected Activities button that appears above the list of activities.

What is the co-provided accreditation statement?

There is no specific "co-provided" accreditation statement. If two or more accredited providers are working in collaboration on a CME activity, one provider must take responsibility for the compliance of that activity, and therefore, use the directly provided accreditation statement with its name. See the ACCME's Accreditation Statement Policy for a copy of the directly provided accreditation statement.

How do I report Journal Based CME in PARS?

When you report Journal-Based CME in PARS, report each article as one activity. For hours of instruction, specify the amount of time required to complete the activity. The number of participants should equal the total number of individuals who completed the activity.

How can I update my organization type?

When an organization first applies for ACCME accreditation, it self-selects its organization type.  ACCME uses this information for reporting and analysis purposes.  Providers may not change their organization type unless the nature of their organization has changed significantly.  If you would like ACCME to change your organization type, please contact us with an explanation of the reason for the request.

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