Accredited CME providers that are interested in conducting the long-term evaluations might provide service in support of the ER/LA Opioid Analgesics REMS in the following ways:
Accredited CME providers that are interested in conducting the long-term evaluations might provide service in support of the ER/LA Opioid Analgesics REMS in the following ways:
The RPC has hired the Campbell Alliance, Ltd. to manage the commercial support. So, in this complicated case, for simplicity, the ACCME is allowing providers to specify the “RPC/Campbell Alliance, Ltd.” as the commercial supporter.
The FDA has provided the following description of the REMS Long-Term Evaluations in its ER/LA Opioid Analgesics REMS Supporting Document:
The REMS Program Companies (RPC) are responsible to the FDA for fulfilling the requirements for long-term evaluations. The RPC will provide funding to organizations that will conduct the long-term evaluations in accordance with FDA specifications.
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.
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.
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
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.
Yes. ACCME will report this data, in aggregate, to the stakeholder community.
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.
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.
Yes. You can download a report of the REMS-specific data associated with your REMS activities, by clicking on the Activities tab, and then clicking on Download REMS Activities from the left-hand navigation menu. Note that this report will only appear if you have entered a REMS activity.
At the bottom of the Add an Activity screen, you will see a section called Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS). Follow the instructions to enter data about REMS-compliant and REMS-related activities.
Providers accredited by the ACCME or an ACCME Recognized Accreditor can participate in the data collection process by entering REMS data in the REMS section of the web-based interface in PARS for each REMS activity they provide.
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).
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.
The FDA has mandated that the REMS Program Companies (RPC) report to the FDA on the progress of implementing the ER/LA Opioid Analgesic REMS and that there be an independent audit of REMS-compliant accredited CE activities to confirm that the education has met the FDA requirements. The FDA has agreed that accrediting bodies can serve as the independent auditors.
Yes. Accredited CME providers can base their activities on the FDA blueprint and be in compliance with the ACCME Standards for Commercial SupportSM: Standards to Ensure Independence in CME Activities. As with any CME activity, accredited providers within the ACCME system must comply with the ACCME accreditation requirements.
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:
No. The ACCME does not require that providers use a disclosure form to gather information about relevant financial relationships of all persons in control of the content of an educational activity. A disclosure form is one mechanism that providers may use to obtain (and show that they possess) this information. Other examples could include:
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
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, 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.
Financial relationships are those relationships in which the individual benefits by receiving, 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.
SCS 2.1 says that providers “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.” Therefore, the provider must do both of the following:
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.
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.
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 sponsor.
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.
No. An accredited CME provider cannot use content developed by an ACCME-defined commercial interest in CME activities because that would be noncompliant with Standard for Commercial Support 1: Independence.
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.
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.
The ACCME appreciates that the FDA recognizes the value of accredited education and chose to leverage the CE system to carry out this important public health initiative. The ACCME has a long-standing commitment to supporting the role of accredited CME as a strategic partner in public health and safety initiatives.
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.
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.
Yes. For CME activities in which the learner participates electronically (e.g., via the Internet), all required information specified in the ACCME’s Enduring Materials: Definition and Requirements Policy and the Internet CME Policy must be made accessible to the learner prior to the learner beginning the CME activity. Providers may use tabs, links, "click here" buttons, rollover text, or other electronic means to make this information accessible.
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.
The ACCME defines 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 does not consider providers of clinical service directly to patients to be commercial interests.” See ACCME’s Definition of Commercial Interest for more information.
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.
When you click on the Batch Upload Activities button in PARS, to begin the batch upload process, you are prompted to indicate whether you are batch uploading activities that occurred in a “Reporting Year 2011 or later” or in a “Reporting Year 2010 or earlier.” The following is a description of the differences in reporting commercial support for activities that occurred before 2011 and reporting activities that occurred in 2011 or after:
There are several fields regarding commercial support that you are required to complete at the individual CME activity level. The following are explanations of each field that appear for activities recorded in Reporting Year 2011 or later:
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.
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.
Committee learning is a CME activity that involves a physician learner’s participation in a committee process where the subject of which, if taught/learned in another format would be considered within the definition of CME.
Test Item Writing CME activities may consist of either of the following processes:
Test item writing is a CME activity based on a learner’s participation in the pre-publication development and review of any type of test-item (e.g., multiple choice questions, standardized patient cases).
Manuscript review CME is based on a learner’s participation in the pre-publication review process of a manuscript.
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.
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).
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.
An internet live course is an online course available at a certain time on a certain date and is only available in real-time, just as if it were a course held in an auditorium. Once the event has taken place, learners may no longer participate in that activity. (Example: webcast)
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.
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.
In 2002, the ACCME adopted special policy for Regularly Scheduled Series in healthcare institutions, in academic medical centers. Regularly Scheduled Series are what people call grand rounds. They’re the education by the physicians of the center, for the physicians of the center. There are several series in most institutions, usually representing clinical care areas or medical specialties. And they’re repeated a number of times in different sessions throughout the year.
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.
Through self-assessment or self-audit, the physicians in an ACCME accredited group practice might identify the following professional practice gap:
Yes... at this point an assessment of change is required for each CME activity. The information is then analyzed by the CME provider in the context of the overall program's effectiveness. Criteria 11 and 12 require the provider to have knowledge of the effectiveness of their Program of CME in the context of changes in competence, performance, or patient outcomes.
Yes, evaluation of learners' change in competence, performance or patient outcomes is required.
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."
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.
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.
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.
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.
It is expected that CME providers will enhance the impact of CME in their system, or micro system, when they are in collaborative or cooperative alliances with other stakeholders in quality.
Perfectly. The ACCME Accreditation Criteria require that all CME activities planned and implemented by an accredited provider address educational needs derived from a professional practice gap of the provider's own leaner(s) and are designed and evaluated with regard to changes in competence, performance, or patient outcomes.
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.
Criterion 1 says, "expected results articulated in terms of changes in competence, performance, or patient outcomes that will be the result of the program." What definition of "competence" is ACCME using? Does it mean knowledge and skill, or does it mean the application of knowledge or skill in practice? If the later is true, how does it differ from performance?
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."
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.
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.
No. Previous activity evaluations may contain expressions of need that underlie professional practice gaps.
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.
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.
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.
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.
This allows the learners to distinguish between missing disclosure information and the circumstances where there is nothing to disclose.
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).
While the logo can appear, the provider cannot acknowledge support only by showing the commercial supporter's logo. The acknowledgement needs to specifically tell the learner that the commercial supporter gave support for the activity. The acknowledgment of commercial support cannot contain any product promotion.
Yes. Please see the Rule Making Policy at ACCME for information about this process.
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, trade name or a product-group message associated with them.
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.
Yes. It contains logistical and organizational information and not education materials. It contains maps and floor plans but not slides and not abstracts.
In SCS 4.5, the ACCME requires that accredited providers to use their own distribution channels for CME activities. To that extent, having a CME enduring material created for the exclusive purpose of use in promotional visits to physicians' offices, for example, would not be in keeping with the concept of separating CME from promotion.
Yes. A Provider would not be out of compliance with the Standards for Commercial Support.
No. Communication or distribution mechanisms that are owned or controlled by a commercial interest cannot be used to transmit or distribute continuing medical education activities to learners (e.g., a cable TV network or website owned and controlled by a commercial interest).
CME exists to support the physician change and learning -- so as to increase their ability to participate in providing quality healthcare or improved healthcare. ACCME expects that providers will always be able to demonstrate how each activity contributes to quality and/or improvement in healthcare, and is, therefore, aligned with what is in the best interest of the public.
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.
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.
No. The ACCME has no specific policy on this matter. The decision is an organizational one for the provider.
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.
No. The Provider is not accountable to the ACCME for the content of advertising and exhibits. The information transferred in an advertisement or exhibit is not part of the Provider's program of continuing medical education activities.
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.
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.
The ACCME intends for the CME Provider to be the one to decide how much people are paid for their services as planners, faculty, and authors in CME activities.
No. All commercial support must be stipulated by a written agreement and must flow through the Provider and/or its educational partner. Only the Provider and/or its educational partner can make payments to people for their role(s) in the activity.
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.
Meals or social events compete with educational events when they happen at the same time in a different location or when they are the main attraction at the educational activity.
No they are not prohibited. Working and learning through meal time is an efficiency often included in bona fide CME activities.
Using commercial support to pay for modest meals and social events at CME activities has been allowed for years. However, providers must avoid making meals or social events longer or more important or more costly than the educational activity, for example.
Commercial support underwrites the provider's expenses for developing and presenting an activity. Commercial support can be used to pay for the expenses of teachers and authors as well others who are working for the provider on the activity.
Yes. ACCME considers meals arranged by the Provider in conjunction with an activity to be an appropriate part of the expenses of a meeting and can be paid for out of the commercial support.
Yes. The ACCME accepts electronic signatures as evidence that written agreements are signed.
No - commercial support does not have to be in a single payment or grant.
When there is commercial support there must be a written agreement that,
Yes. The agreement must describe the terms, conditions and purposes of the commercial support grant and be signed by the commercial supporter and the accredited provider.
The ACCME expects that written agreements for commercial support will:
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.)
Yes. An accredited provider can fulfill the expectations of SCS 3.4 to 3.6 by adopting a previously executed agreement between an accredited provider and a commercial supporter and indicating in writing their acceptance of the terms and conditions specified and the amount of commercial support they will receive.
No. The Provider or its agents (e.g., staff, managers, educational partners or joint sponsors) must decide what commercial support will be accepted and how it will be spent or used.
There is no CME reason for commercial supporters to review and comment on CME content prior to its delivery to learners. An accredited provider would be out of compliance with SCS 1.1 and 3.2 if it were obligated to allow a content review by a commercial supporter as a condition of its contributing funds or services.
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.
No. The commercial support must go first to the provider or a provider's joint sponsor or a provider's educational partner.
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.
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.
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.
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.
What follows is an example of how several tactics can be tied together by the Provider into a mechanism to resolve conflicts of interest that could demonstrate the Provider's compliance with the ACCME requirements, and preserve participation of experts with financial relationships.
Yes. Refusal to disclosure is not limited to the explicit act of saying "no" to a provider's request for such information. Unresponsiveness that precludes the provider from implementing a mechanism to identify and resolve COI is equivalent to a refusal.
No. The ACCME expects providers to disqualify all individuals each time they refuse to provide information on their relevant financial relationships.
You must not carry on with the activity under these circumstances. The person cannot participate if they refuse to disclose because conflicts of interest can neither be identified nor 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.
The ACCME expects that this is a rare event and expects that providers would have plans to manage this contingency as part of their institutional mechanisms for resolving conflicts of interest. Each provider is free to develop the strategy that best suits their circumstances.
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.
YES. The provider always has the option to exclude some presentations or abstracts from their accredited program of CME or present this content in a track that is outside of but in conjunction with accredited CME. This option also preserves the free flow of information.
Yes. Verbal disclosure to the provider is acceptable as long as the provider can verify for the ACCME at accreditation what information was collected for the conflict of interest identification and resolution processes.
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.
Financial relationships are those relationships in which the individual benefits by receiving , 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.
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.
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.
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.
No. Compliance with SCS 2.1 requires that disclosure is made. Disclosing the same information repeatedly to the same Provider is not necessary. With the original disclosure information, the Provider is able to implement its mechanism to resolve any conflicts of interest.
An accredited provider is required to retain activity files/records during the current accreditation term or for the last twelve months, whichever is longer. For more information, see the ACCME's policy on records retention.
Joint sponsors 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 sponsor cannot be a commercial interest. For further information on this topic, please click here to view the ACCME policy on joint sponsorship.
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.
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:
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
There is no CME reason for commercial supporters to review and comment on CME content prior to its delivery to learners. 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 content of CME that the employee of the commercial interest controls relates to the business lines and products of its employer - NO.
If the content of CME that the employee of the commercial interest controls DOES NOT relate to the business lines and products of its employer - YES.
The ACCME has worked closely with accredited providers as they have adapted their CME programs to comply with the ACCME policy regarding the role of commercial interest employees in accredited CME. Accredited providers have offered us the following examples.
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 sponsored). The only ACCME requirement is that the correct accreditation statement be used somewhere within the brochure.
No. The accredited provider is required to record learner participation and be able to verify learner participation for six years from the date of the CME activity. See ACCME's policies on Attendance Records Retention.
The following institutions are eligible to seek accreditation directly from the ACCME:
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.
The process of seeking first-time, or "initial" accreditation from the ACCME generally takes twelve to eighteen months. The reaccreditation process for providers that are already ACCME-accredited takes approximately fifteen months. Refer to the For CME Providers section of our website to see a description of the process and the steps involved.
An accredited provider must have mechanisms in place to record and, when authorized by the participating physician, verify participation for six years from the date of the CME activity. For more information, see the ACCME's policy on records retention.
No. See ACCME's policy on joint sponsorship for more information.
All CME activities developed and presented by an accredited provider, including those designated for credit, become part of that provider's program of CME . The program must be in compliance with all ACCME accreditation requirements. Therefore, all activities designated for, or awarded, credit will be subject to review by the ACCME accreditation process.
No, there is no requirement that the provider have a CME committee.
No. Nonphysicians can be faculty at a CME activity.
No longer than three years. The ACCME policy on enduring materials requires both an original release date and an expiration date. In addition, the ACCME policy requires that you review each enduring material at least once every three years or more frequently if indicated by new scientific developments.
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.
No, there are no special ACCME requirements for activities that ACCME-accredited providers hold overseas. All activities provided by ACCME-accredited providers must comply with ACCME's Accreditation Requirements, regardless of their location.
The ACCME primarily accredits organizations within the US and its territories. However, international organizations are encouraged to apply for accreditation. International organizations will be reviewed for eligibility when they submit their pre-application. For more information, please see The Pre-Application Process.
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.
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.
Yes. The new CME activity, must demonstrate compliance with all applicable ACCME accreditation requirements, including faculty disclosure and acknowledgement of any commercial support (SCS 6).
Yes, if educational material from a live activity is turned into an enduring material, the enduring material is considered a separate activity.
No. The ACCME does not require post-tests for any type of CME activity. In journal CME, some sort of challenge must be presented to the learner that is based on the content of the educational activity but we do not call it a post test.
No. Typically these cards contain only initial, preliminary information like the activity date and location. If more specific information is included, such as faculty and objectives, the accreditation statement must be included.
The decision regarding how you acknowledge their involvement or what words to use is up to you. See the ACCME's policies regarding the accreditation statement for a copy of the accreditation statement.
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."
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.
The ACCME will review the complaint to determine whether the complaint relates to the provider's compliance with the ACCME accreditation requirements, and then follow one of these courses of action:
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.
No. ACCME accreditation is awarded to the organization that sought the accreditation and was able to demonstrate compliance with ACCME's Accreditation Requirements. See "Informing ACCME of Personnel or Organizational Changes" for more information.
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.
No. The ACCME Process for Handling Complaints Regarding ACCME Accredited Providers requires that all complaints submitted "confirm the name, US Postal Service address and contact information of the person making the submission."
Below is a list of the different CME activity formats that can be reported in the PARS System. You can click on the name of any of these activity formats for a definition and additional information:
A course is identified as a regularly scheduled series (RSS) when it is planned to have
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).
A directly sponsored activity is one that is planned, implemented and evaluated by the accredited provider. Include co-sponsored activities (provided by two accredited providers) in this category if you are the accredited provider awarding the credit. In contrast, a jointly sponsored 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 Sponsorship
“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
Hours of instruction equals the total hours of educational instruction provided. For example, if a one-day course lasts eight (8) hours (not including breaks or meals), then total hours of instruction reported for that course is 8.
See the ACCME FAQs about regularly scheduled series, manuscript review and learning from teaching for additional specific examples regarding calculating hours of instruction for these types of activities.
No. Please report the total number of non-resident MDs and DOs who participated in the activity, even if they did not seek CME credit for attending.
ACCME defines non-physician participants as attendees other than MDs and DOs, such as nurses, physician assistants, and other health professionals. Include residents in this category.
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.
Commercial Support for a CME activity 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. The definition of roles and requirements when commercial support is received are outlined in the ACCME Standards for Commercial Support (SM).
Upon launch, only fields that are currently required by ACCME for reaccreditation purposes or were previously required on the Annual Report are required by PARS.
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.”
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.
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.
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.
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
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.
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):
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.
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
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
Yes, the accredited provider must report the full amount of commercial support received, even if the commercial support is distributed to other non-accredited joint sponsors.
On this line, please report the total of any and all income your activity received that does not fall under commercial support or advertising and exhibit income. The most common examples of "income from other sources" includes:
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.
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.
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.
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.
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.
Activities that are offered over the course of multiple reporting years - such as Enduring Materials - should be reported in PARS for each year in which they are active, regardless of whether they are active for the entire year or just a part of it.
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:
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.
There is no specific "co-sponsorship" 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 sponsored accreditation statement with its name. See the ACCME's policies regarding the accreditation statement for a copy of the directly sponsored accreditation statement.
There are three (3) components of your organization’s year-end reporting to the ACCME:
The Program Summary is a summary of the income and expense attributable to your CME Program for the year. The Program Summary reflects two kinds of data:
Yes. Organizations must complete all of the fields on the Program Summary. If your organization did not have any programmatic income or expense for the year, you should enter zero (“0”) into each of the blank fields.
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.
If your organization assigns an internal code or identifier to each of its CME activities, you may enter it into this field.
PARS data will not be accessible to the public. Accredited providers will have secure logins and their information will only be shared in accordance with ACCME's Information and Confidentiality Policies.
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.
For providers receiving accreditation decisions in November 2011 or later, for reaccreditation purposes, you will be required to submit data about activities that you provided during your current accreditation term. If your current accreditation term pre-dates January 2008, you do not need to provide data for activities that occurred prior to that date.