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The ACCME Accreditation Requirements December 2018 TABLE OF CONTENTS ACCREDITATION CRITERIA .........................................................................................................................................................................2 OPTION A: ACCREDITATION WITH COMMENDATION ...................................................................................................................3 OPTION B: MENU OF N EW CRITERIA FOR ACCREDITATION WITH COMMENDATION .......................................................4 STANDARDS FOR COMMERCIAL SUPPORT: STANDARDS TO ENSURE INDEPENDENCE IN CME ACTIVITIES...............5 ACCME POLICIES ........................................................................................................................................................................................ 9 ACCME GOVERNANCE ........................................................................................................................................................................9 CME PROGRAM AND ACTIVITY ADMINISTRATION.................................................................................................................... 11 JOINT PROVIDERSHIP .......................................................................................................................................................................... 14 POLICIES SUPPLEMENTING THE STANDARDS FOR COMMERCIAL SUPPORT .................................................................. 15 ©2012, 2013, 2014, 2016, 2017, 2018 by the Accreditation Council for Continuing Medical Education All Rights Reserved 401 N. Michigan Ave., Suite 1850 | Chicago, IL 60611 | Phone: 312/527-9200 | www.accme.org

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Page 1: The ACCME Accreditation Requirements€¦ · ACCME Accreditation Requirements 626_20190125 Page | 5 ©2012,2013, 2014, 2016, 2017, 2018 STANDARDS FOR COMMERCIAL SUPPORT: STANDARDS

The ACCME Accreditation Requirements

December 2018

TABLE OF CONTENTSACCREDITATION CRITERIA .........................................................................................................................................................................2

OPTION A: ACCREDITATION WITH COMMENDATION ...................................................................................................................3 OPTION B: MENU OF NEW CRITERIA FOR ACCREDITATION WITH COMMENDATION .......................................................4

STANDARDS FOR COMMERCIAL SUPPORT: STANDARDS TO ENSURE INDEPENDENCE IN CME ACTIVITIES...............5

ACCME POLICIES ........................................................................................................................................................................................9 ACCME GOVERNANCE ........................................................................................................................................................................9

CME PROGRAM AND ACTIVITY ADMINISTRATION.................................................................................................................... 11 JOINT PROVIDERSHIP.......................................................................................................................................................................... 14

POLICIES SUPPLEMENTING THE STANDARDS FOR COMMERCIAL SUPPORT .................................................................. 15

©2012, 2013, 2014, 2016, 2017, 2018 by the Accreditation Council for Continuing Medical Education All Rights Reserved 401 N. Michigan Ave., Suite 1850 | Chicago, IL 60611 | Phone: 312/527-9200 | www.accme.org

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ACCREDITATION CRITERIA Initial applicants seeking to achieve Provisional Accreditation, a two year term, must comply with Criteria 1, 2, 3, and 7–12. Providers seeking full Accreditation or reaccreditation for a four-year term must comply with Criteria 1–13. Providers also have the option to aim to achieve Accreditation with Commendation, a six-year term. Providers seeking commendation must comply with Criteria 1–13 and choose one of the following two options. Providers that will receive accreditation decisions between November 2017 and November 2019 will have the choice of using either Option A: Commendation Criteria (C16-C22) or Option B: Menu of New Commendation Criteria (C23-C38) to seek Accreditation with Commendation. Providers that will receive accreditation decisions after November 2019 must use Option B to seek Accreditation with Commendation. More information on Accreditation with Commendation options is available here.

Criterion 1 The provider has a CME mission statement that includes expected results articulated in termsof changes in competence, performance, or patient outcomes that will be the result of the program.

Criterion 2 The provider incorporates into CME activities the educational needs (knowledge, competence,or performance) that underlie the professional practice gaps of their own learners.

Criterion 3 The provider generates activities/educational interventions that are designed to changecompetence, performance, or patient outcomes as described in its mission statement.

Criterion 4 This criterion has been eliminated effective February 2014.

Criterion 5 The provider chooses educational formats for activities/interventions that are appropriate forthe setting, objectives, and desired results of the activity.

Criterion 6 The provider develops activities/educational interventions in the context of desirablephysician attributes [eg, Institute of Medicine (IOM) competencies, Accreditation Council for Graduate Medical Education (ACGME) Competencies].

Criterion 7 The provider develops activities/educational interventions independent of commercialinterests. (SCS 1, 2, and 6).

Criterion 8 The provider appropriately manages commercial support (if applicable, SCS 3 of theACCME Standards for Commercial SupportSM).

Criterion 9 The provider maintains a separation of promotion from education (SCS 4).

Criterion 10 The provider actively promotes improvements in health care and NOT proprietary interests ofa commercial interest (SCS 5).

Criterion 11 The provider analyzes changes in learners (competence, performance, or patientoutcomes) achieved as a result of the overall program's activities/educational interventions.

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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.

Criterion 13 The provider identifies, plans and implements the needed or desired changes in the overall program (eg, planners, teachers, infrastructure, methods, resources, facilities, interventions) that are required to improve on ability to meet the CME mission.

Criterion 14 This criterion has been eliminated effective February 2014.

Criterion 15 This criterion has been eliminated effective February 2014.

OPTION A: ACCREDITATION WITH COMMENDATION

Criterion 16 The provider operates in a manner that integrates CME into the process for improving professional practice.

Criterion 17 The provider utilizes non-education strategies to enhance change as an adjunct to its activities/educational interventions (e.g., reminders, patient feedback).

Criterion 18 The provider identifies factors outside the provider's control that impact on patient outcomes.

Criterion 19 The provider implements educational strategies to remove, overcome or address barriers to physician change.

Criterion 20 The provider builds bridges with other stakeholders through collaboration and cooperation.

Criterion 21 The provider participates within an institutional or system framework for quality improvement.

Criterion 22 The provider is positioned to influence the scope and content of activities/educational interventions.

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OPTION B: MENU OF NEW CRITERIA FOR ACCREDITATION WITH COMMENDATION

Criterion 23 Members of interprofessional teams are engaged in the planning and delivery of interprofessional continuing education (IPCE).

Criterion 24 Patient/public representatives are engaged in the planning and delivery of CME.

Criterion 25 Students of the health professions are engaged in the planning and delivery of CME.

Criterion 26 The provider advances the use of health and practice data for healthcare improvement.

Criterion 27 The provider addresses factors beyond clinical care that affect the health of populations.

Criterion 28 The provider collaborates with other organizations to more effectively address population health issues.

Criterion 29 The provider designs CME to optimize communication skills of learners.

Criterion 30 The provider designs CME to optimize technical and procedural skills of learners.

Criterion 31 The provider creates individualized learning plans for learners.

Criterion 32 The provider utilizes support strategies to enhance change as an adjunct to its CME.

Criterion 33 The provider engages in CME research and scholarship.

Criterion 34 The provider supports the continuous professional development of its CME team.

Criterion 35 The provider demonstrates creativity and innovation in the evolution of its CME program.

Criterion 36 The provider demonstrates improvement in the performance of learners.

Criterion 37 The provider demonstrates healthcare quality improvement.

Criterion 38 The provider demonstrates the impact of the CME program on patients or their communities.

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STANDARDS FOR COMMERCIAL SUPPORT: STANDARDS TO ENSURE INDEPENDENCE IN CME ACTIVITIES S T ANDARD 1: I N D EPEND ENC E

STANDARD 1.1 A CME provider must ensure that the following decisions were made free of the control of a commercial interest. (See the Policies Supplementing the Standards for Commercial Support for a definition of a "commercial interest" and some exemptions.) (a) Identification of CME needs; (b) Determination of educational objectives; (c) Selection and presentation of content; (d) Selection of all persons and organizations that will be in a position to control the content of the CME; (e) Selection of educational methods; (f) Evaluation of the activity.

STANDARD 1.2 A commercial interest cannot take the role of non-accredited partner in a joint provider relationship.

S T ANDARD 2: R ESOLUTI ON O F P E R SONAL C ONF LIC TS OF I NTE REST

STANDARD 2.1 The 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. The ACCME defines "'relevant' financial relationships” as financial relationships in any amount occurring within the past 12 months that create a conflict of interest.

STANDARD 2.2 An individual who refuses to disclose relevant financial relationships will be disqualified from being a planning committee member, a teacher, or an author of CME, and cannot have control of, or responsibility for, the development, management, presentation or evaluation of the CME activity.

STANDARD 2.3 The provider must have implemented a mechanism to identify and resolve all conflicts of interest prior to the education activity being delivered to learners.

S T ANDARD 3: A PPROP RIATE U S E O F C OMM ERCIAL S U PPORT

STANDARD 3.1 The provider must make all decisions regarding the disposition and disbursement of commercial support.

STANDARD 3.2 A provider cannot be required by a commercial interest to accept advice or services concerning teachers, authors, or participants or other education matters, including content, from a commercial interest as conditions of contributing funds or services.

STANDARD 3.3 All commercial support associated with a CME activity must be given with the full knowledge and approval of the provider.

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STANDARD 3.4 The terms, conditions, and purposes of the commercial support must be documented in a written agreement between the commercial supporter that includes the provider and its educational partner(s). The agreement must include the provider, even if the support is given directly to the provider's educational partner or a joint provider.

STANDARD 3.5 The written agreement must specify the commercial interest that is the source of commercial support.

STANDARD 3.6 Both the commercial supporter and the provider must sign the written agreement between the commercial supporter and the provider.

STANDARD 3.7 The provider must have written policies and procedures governing honoraria and reimbursement of out-of-pocket expenses for planners, teachers and authors.

STANDARD 3.8 The provider, the joint provider, or designated educational partner must pay directly any teacher or author honoraria or reimbursement of out-of–pocket expenses in compliance with the provider's written policies and procedures.

STANDARD 3.9 No other payment shall be given to the director of the activity, planning committee members, teachers or authors, joint provider, or any others involved with the supported activity.

STANDARD 3.10 If teachers or authors are listed on the agenda as facilitating or conducting a presentation or session, but participate in the remainder of an educational event as a learner, their expenses can be reimbursed and honoraria can be paid for their teacher or author role only.

STANDARD 3.11 Social events or meals at CME activities cannot compete with or take precedence over the educational events.

STANDARD 3.12 The provider may not use commercial support to pay for travel, lodging, honoraria, or personal expenses for non-teacher or non-author participants of a CME activity. The provider may use commercial support to pay for travel, lodging, honoraria, or personal expenses for bona fide employees and volunteers of the provider, joint provider or educational partner.

STANDARD 3.13 The provider must be able to produce accurate documentation detailing the receipt and expenditure of the commercial support.

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S T ANDARD 4: A PPROP RIATE M A NAGEMENT OF A SSOCIATED C OMM ERCI AL P ROMOTI ON

STANDARD 4.1 Arrangements for commercial exhibits or advertisements cannot influence planning or interfere with the presentation, nor can they be a condition of the provision of commercial support for CME activities.

STANDARD 4.2 Product-promotion material or product-specific advertisement of any type is prohibited in or during CME activities. The juxtaposition of editorial and advertising material on the same products or subjects must be avoided. Live (staffed exhibits, presentations) or enduring (printed or electronic advertisements) promotional activities must be kept separate from CME.

• For print, advertisements and promotional materials will not be interleafed within the pages of the CME content. Advertisements and promotional materials may face the first or last pages of printed CME content as long as these materials are not related to the CME content they face and are not paid for by the commercial supporters of the CME activity.

• For computer based CME activities, advertisements and promotional materials will not be visible on the screen at the same time as the CME content and not interleafed between computer ‘windows’ or screens of the CME content. Also, ACCME-accredited providers may not place their CME activities on a Web site owned or controlled by a commercial interest. With clear notification that the learner is leaving the educational Web site, links from the Web site of an ACCME accredited provider to pharmaceutical and device manufacturers’ product Web sites are permitted before or after the educational content of a CME activity, but shall not be embedded in the educational content of a CME activity. Advertising of any type is prohibited within the educational content of CME activities on the Internet including, but not limited to, banner ads, subliminal ads, and pop-up window ads.

• For audio and video recording, advertisements and promotional materials will not be included within the CME. There will be no ‘commercial breaks.’

• For live, face-to-face CME, advertisements and promotional materials cannot be displayed or distributed in the educational space immediately before, during, or after a CME activity. Providers cannot allow representatives of Commercial Interests to engage in sales or promotional activities while in the space or place of the CME activity.

• For Journal-based CME, none of the elements of journal-based CME can contain any advertising or product group messages of commercial interests. The learner must not encounter advertising within the pages of the article or within the pages of the related questions or evaluation materials.

STANDARD 4.3 Educational materials that are part of a CME activity, such as slides, abstracts and handouts, cannot contain any advertising, corporate logo, trade name or a product-group message of an ACCME-defined commercial interest.

STANDARD 4.4 Print or electronic information distributed about the non-CME elements of a CME activity that are not directly related to the transfer of education to the learner, such as schedules and content descriptions, may include product-promotion material or product-specific advertisement.

STANDARD 4.5 A provider cannot use a commercial interest as the agent providing a CME activity to learners, e.g., distribution of self-study CME activities or arranging for electronic access to CME activities.

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S T ANDARD 5: C ONTE NT A N D F O R MAT W ITHOUT C OMM ERCI AL B I AS

STANDARD 5.1 The content or format of a CME activity or its related materials must promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

STANDARD 5.2 Presentations must give a balanced view of therapeutic options. Use of generic names will contribute to this impartiality. If the CME educational material or content includes trade names, where available trade names from several companies should be used, not just trade names from a single company.

S T ANDARD 6: D ISCLOSU RES R E LEVANT T O P OTENTI A L C O MMERCIAL B IAS

STANDARD 6.1 An individual must disclose to learners any relevant financial relationship(s), to include the following information: The name of the individual; The name of the commercial interest(s); The nature of the relationship the person has with each commercial interest.

STANDARD 6.2 For an individual with no relevant financial relationship(s) the learners must be informed that no relevant financial relationship(s) exist.

STANDARD 6.3 The source of all support from commercial interests must be disclosed to learners. When commercial support is "in-kind‟ the nature of the support must be disclosed to learners.

STANDARD 6.4 'Disclosure' must never include the use of a corporate logo, trade name or a product- group message of an ACCME-defined commercial interest.

STANDARD 6.5 A provider must disclose the above information to learners prior to the beginning of the educational activity.

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ACCME POLICIES The ACCME issues policies that supplement the ACCME Criteria and Standards for Commercial Support. Accredited providers must adhere to the ACCME policies that are relevant to their organizations, as well as to the Accreditation Criteria and the ACCME Standards for Commercial Support.

ACCME Notes, which provide explanatory information about the policies, and other educational resources, are available at www.accme.org.

ACCME GOVERNANCE

PUBLIC AND CONFIDENTIAL INFORMATION ABOUT ACCREDITED PROVIDERS

The following information is considered public information, and therefore may be released by the ACCME. Public information includes certain information about accredited providers, and ACCME reserves the right to publish and release to the public, including on the ACCME Web site, all public information:

1. Names and contact information for accredited providers;

2. Accreditation status of provider;

3. Some annual report data submitted by the accredited provider, including for any given year:

o Number of activities;

o Number of hours of education;

o Number of physician participants;

o Number of designated AMA PRA Category 1 CreditsTM;

o Competencies that activities were designed to address;

o Number of nonphysician participants;

o Accepts commercial support (yes or no);

o Accepts advertising/exhibit revenue (yes or no);

o Participates in joint providership (yes or no);

o Types of activities produced (list)

Note: The ACCME will not release any dollar amounts reported by individual accredited providers for income, commercial support, or advertising/exhibits.

4. Aggregated accreditation finding and decision data broken down by provider type;

5. Responses to public calls for comment initiated by the ACCME;

6. Executive summaries from the ACCME Board of Directors’ Meetings (exclusive of actions taken during executive session); and

7. Any other data/information that ACCME believes qualifies as "public information."

The ACCME reserves the right to use and/or share anonymized PARS data for research purposes, in keeping with the guidance of the ACCME Board of Directors.

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The ACCME will maintain as confidential information, except as required for ACCME accreditation purposes, or as may be required by legal process, or as otherwise authorized by the accredited provider to which it relates:

1. To the extent not described as public information above, information submitted to the ACCME by the provider during the initial or reaccreditation decision-making processes for that provider;

2. Correspondence to and from ACCME relating to the accreditation process for a provider; and

3. ACCME proceedings (e.g., Board minutes, transcripts) relating to a provider, other than the accreditation outcome of such proceedings.

In order to protect confidential information, ACCME and its volunteers are required:

1. Not to make copies of, disclose, discuss, describe, distribute or disseminate in any manner whatsoever, including in any oral, written, or electronic form, any confidential information that the ACCME or its volunteers receive or generate, or any part of it, except directly for the accreditation or complaint/inquiry decision-making purposes;

2. Not to use such confidential information for personal or professional benefit, or for any other reason, except directly for ACCME purposes.

RULE-MAKING POLICY

1. The notice and comment procedures utilized by ACCME for the adoption of rules and policies that directly impact members and accredited providers (the “Notice and Comment Procedures”) shall not apply to matters relating to internal ACCME structure, management, personnel or business policy/practices.

a. The Notice and Comment Procedures will only apply to matters which directly and materially impact the ability of accredited providers to conduct business.

b. The ACCME, in its sole discretion, will assess if any particular rule or policy will be subject to the Notice and Comment Procedures.

2. If the ACCME decides to seek and accept public comment or input, then the ACCME will publish the proposed rule or policy on its website and state that interested persons have an opportunity to submit written data, views, or arguments with or without opportunity for oral presentation.

3. If the ACCME decides to seek and accept public comment or input, then at least 30 days will be given to provide that comment or input; provided, however, that if the ACCME determines that there is a pressing need for issuance of a rule or policy on an expedited basis, the ACCME may either shorten or eliminate the period of time during which public comments may be submitted.

4. After any period for public comment, the proposed rule or policy will be submitted to the ACCME Board of Directors. The ACCME Board of Directors may modify, reject, defer, and/or adopt the proposed rule or policy. Subject to the rights of ACCME Members contained in Article III, Section 2(c) of the ACCME Bylaws, the decision of the ACCME Board of Directors shall be final and there shall be no appeal there from.

5. The final rule or policy as approved by the ACCME Board of Directors will be posted on the ACCME website, which will include an effective date for the final rule or policy.

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CME PROGRAM AND ACTIVITY ADMINISTRATION

ORGANIZATIONAL MISSION AND FRAM EWORK

This policy has been eliminated effective February 2014.

ACCME ACCREDITED PROVIDER MARKS

Providers accredited within the ACCME System (providers directly accredited by the ACCME and those accredited by ACCME Recognized Accreditors) are welcome to use the ACCME Accredited mark for educational and identification purposes, and in announcements related to their attainment of ACCME accreditation. While the mark may be resized, the original aspect ratio should be maintained (it should not be stretched or condensed in a way that causes it to become distorted). Except for resizing, no other changes can be made.

ACCME-accredited and state-accredited providers that have achieved Accreditation with Commendation may also use the ACCME Accredited with Commendation mark for educational and identification purposes and in announcements related to their attainment of Accreditation with Commendation.

Accredited Provider Mark

Accredited with Commendation Provider Mark

ACCREDITATION STATEMENT

The accreditation statement must appear on all CME activity materials and brochures distributed by accredited organizations, except that the accreditation statement does not need to be included on initial, save-the-date type activity announcements. Such announcements contain only general, preliminary information about the activity such as the date, location, and title. If more specific information is included, such as faculty and objectives, the accreditation statement must be included.

The ACCME accreditation statement is as follows:

For directly provided activities: “The (name of accredited provider) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.”

For jointly provided activities: “This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of (name of accredited provider) and (name of nonaccredited provider). The (name of accredited provider) is accredited by the ACCME to provide continuing medical education for physicians.”

There is no "co-providership" 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. Co- provided CME activities should use the directly provided activity statement, naming the one accredited provider that is responsible for the activity. The ACCME has no policy regarding specific ways in which providers may acknowledge the involvement of other ACCME-accredited providers in their CME activities.

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ADMINISTRATIVE DEADLINES

ACCME-accredited providers and Recognized Accreditors are accountable for meeting ACCME administrative deadlines. Failure to meet ACCME administrative deadlines could result in (a) an immediate change of status to Probation, and (b) subsequent consideration by the Board of Directors for a change of status to Nonaccreditation or Nonrecognition.

CME ACTIVITY AND ATTENDANCE RECORDS RETENTION

1. Attendance Records: 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. The accredited provider is free to choose whatever registration method works best for their organization and learners. The ACCME does not require sign-in sheets.

2. Activity Documentation: An accredited provider is required to retain activity files/records of CME activity planning and presentation during the current accreditation term or for the last twelve months, whichever is longer.

CME CLINICAL CONTENT VALIDATION

Accredited providers are responsible for validating the clinical content of CME activities that they provide. Specifically,

1. All the recommendations involving clinical medicine in a CME activity must be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients.

2. All scientific research referred to, reported, or used in CME in support or justification of a patient care recommendation must conform to the generally accepted standards of experimental design, data collection and analysis.

3. Providers are not eligible for ACCME accreditation or reaccreditation if they present activities that promote recommendations, treatment, or manners of practicing medicine that are not within the definition of CME, or known to have risks or dangers that outweigh the benefits or known to be ineffective in the treatment of patients. 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.

CME CONTENT AND THE AMERICAN MEDICAL ASSOCIATION PHYSICIAN’S RECOGNITION AWARD

All CME educational activities developed and presented by a provider accredited by the ACCME system and associated with AMA PRA Category 1 CreditTM must be developed and presented in compliance with all ACCME accreditation requirements - in addition to all the requirements of the AMA PRA program. All activities so designated for, or awarded, credit will be subject to review by the ACCME accreditation process as verification of fulfillment of the ACCME accreditation requirements.

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CME CONTENT: DEFINITION AND EXAMPLES

Continuing medical education consists of educational activities which serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships that a physician uses to provide services for patients, the public, or the profession. The content of CME is that body of knowledge and skills generally recognized and accepted by the profession as within the basic medical sciences, the discipline of clinical medicine, and the provision of health care to the public.

CME PROGRAM BUSINESS AND MANAGEMENT PROCEDURES

The accredited 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.

CONTENT VALIDITY OF ENDURING MATERIALS

Providers that produce enduring materials must review each enduring material at least once every three years or more frequently if indicated by new scientific developments. So, while providers can review and re-release an enduring material every three years (or more frequently), the enduring material cannot be offered as an accredited activity for more than three years without some review on the part of the provider to ensure that the content is still up-to-date and accurate. That review date must be included on the enduring material, along with the original release date and a termination date.

ENGLISH AS OFFICIAL LANGUAGE O F T H E ACCME ACCME conducts its affairs in English. ACCME standards do not require that providers or accreditors conduct all their business or continuing medical education in English. However, ACCME does require that,

1. All written or electronic communications or correspondence with ACCME (irrespective of medium) is in English.

2. Any application and/or self-study reports for accreditation or recognition be submitted to ACCME in English.

3. ACCME is provided with English translations of any written materials requested by ACCME in the course of its accreditation, recognition, or monitoring process.

4. Any ACCME interview for accreditation or recognition be conducted in English, or have the services of an English translator, acceptable to ACCME, provided and paid for by the applicant organization.

FEES FOR ACCME-ACCREDITED PROVIDERS

ACCME-accredited providers are accountable for timely submission of fees that are required either to attain or maintain accreditation. Failure to meet ACCME deadlines could result in an immediate change of status to Probation, and subsequent consideration by the Board of Directors for a change of status to Nonaccreditation. For a list of current fees and related information, see the ACCME-accredited provider fee schedule.

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HIPAA COMPLIANCE ATTESTATION

Every provider applying for either for initial accreditation or reaccreditation must attest to the following:

“The materials we submit for reaccreditation (self-study report, activity files, other materials) will not include individually identifiable health information, in accordance with the Health Insurance Portabi l i ty and Accountability Act (HIPAA), as amended.”

RELEASE OF ACCME AND ITS VOLUNTEERS, CHOICE OF FORUM, AND UNETHICAL

BEHAVIOR

The Accreditation Council for Continuing Medical Education (“ACCME”) accredits organizations that offer continuing medical education. ACCME offers accreditation through a multilevel process (“Process”) to certify continuing medical education providers. Throughout the Process, various individuals, including, without limitation, ACCME’s past and present directors, officers, employees, agents, volunteers, surveyors, content reviewers, attorneys, assigns, successors and insurers (collectively “Participants”), help inform ACCME’s decision-making process. ACCME and the Participants (collectively “Released Parties”) then use information gathered through the Process to make an accrediting decision.

Each organization which seeks accreditation from the ACCME or which is accredited by ACCME shall be referred to as a “Provider.”

In consideration of the willingness of ACCME to: (a) process the application of a Provider which seeks accreditation; or (b) engage in the process of re-accreditation or provide any other services to a Provider who is accredited by ACCME, each Provider, agrees on behalf of itself and its shareholders, members, owners, directors, officers, employees, agents, volunteers, successors, assigns and anyone else who may claim on Provider’s behalf or through Provider (collectively the “Releasing Parties”) as follows:

1. Release and Waiver Releasing Parties knowingly and voluntarily: waive and generally release the Released Parties from any and all claims or causes of action arising out of the Process which the Releasing Parties may have at any time, now or in the future against any Released Party. This waiver and release includes, but is not limited to:

• any and all claims, actions, causes of action or liabilities asserting that any of the Released Parties has violated the policies and procedures of the ACCME, any covenant of good faith and fair dealing, or any express or implied contract of any kind;

• any and all claims, actions, causes of action or liabilities asserting that any of the Released Parties has violated public policy or statutory or common law, including claims for personal injury, invasion of privacy, defamation, intentional or negligent infliction of emotional distress and/or mental anguish, intentional interference with contract, negligence, detrimental reliance, failure to provide due process and/or promissory estoppel;

• any and all claims, actions, causes of action or liabilities asserting that any of the Released Parties are in any way obligated for any reason to pay Releasing Parties damages, expenses, litigation costs (including attorneys’ fees), compensatory damages, punitive damages, and/or interest; and

• all claims of discrimination or retaliation based on such things as age, national origin, ancestry, race, religion, sex, sexual orientation, physical or mental disability or medical condition, and any purported membership or exercise of legally protected rights.

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The Releasing Parties’ waiver and release includes all claims, rights and causes of action that Releasing Parties have or may have under all contract, common law, federal, state and local statutes, ordinances, rules, regulations and orders. All of the items described in this paragraph and the preceding paragraph shall be referred to as the “Released Claims.”

2. Covenant not to Sue and Indemnification In addition, the Releasing Parties, knowingly, intentionally and voluntarily: promise not to sue the Released Parties with respect to any Released Claims; and agrees to defend, indemnify and hold harmless the Released Parties from and against any and all losses, costs, claims, demands, causes of action, injury, damage, and liability whatsoever (including, but not limited to, court costs and attorneys’ fees), whether presently known or unknown, with respect to any claim and/or litigation made or brought by the Releasing Parties with respect to the Released Claims. If any claim and/or litigation is made or brought by a Releasing Party against a Released Party with respect to a Released Claim, the Releasing Parties’ obligation to provide a defense for such a claim and/or litigation shall be fulfilled by the Releasing Parties paying the attorney’s fees of the Released Parties incurred in connection with such claim and/or litigation. The Releasing Parties expressly waive the benefits of any statutory provision or common law rule that provides that a release and waiver of liability does not extend to causes of action of which the Releasing Parties are unaware.

3. Governing Law; Choice of Forum All disputes and litigation between a Releasing Party and a Released Party shall be governed by the laws of the State of Illinois, without regard to its conflicts of laws principles. Any disputes and matters arising between a Releasing Party and a Released Party shall be litigated exclusively before a court located in Cook County, Illinois (or the Federal District for the Northern District of Illinois), and no Releasing Party shall bring any litigation related to a Released Party in any other forum. Each Releasing Party waives any argument that the forum designated by this paragraph is not convenient.

4. Unethical Behavior No Provider shall engage in: disparagement of any of ACCME, ACCME’s past and present directors, officers, employees, agents, volunteers, surveyors, content reviewers, attorneys, assigns, successors and insurers; unethical behavior, including, without limitation, dishonest communications or conduct; or deceptive or misleading advertising. Failure to comply with the standard set forth in this paragraph shall be grounds for corrective action, including, without limitation, reduction or loss of a Provider’s accreditation.

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JOINT PROVIDERSHIP The ACCME defines joint providership as the providership of a CME activity by one accredited and one nonaccredited organization. Therefore, ACCME accredited providers that plan and present one or more activities with non-ACCME accredited providers are engaging in joint providership. Please note: the ACCME does not intend to imply that a joint providership relationship is an actual legal partnership. Therefore, the ACCME does not include the words partnership or partners in its definition of joint providership or description of joint providership requirements.

The accredited provider must take responsibility for a CME activity when it is presented in cooperation with a nonaccredited organization and must use the appropriate accreditation statement.

INFORMING LEARNERS

The accredited provider must inform the learner of the joint providership relationship through the use of the appropriate accreditation statement. All printed materials for jointly provided activities must carry the appropriate accreditation statement.

“This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of (name of accredited provider) and (name of nonaccredited provider). The (name of accredited provider) is accredited by the ACCME to provide continuing medical education for physicians.” — ACCME Accreditation Statement Policy

FEES

The ACCME maintains no policy that requires or precludes accredited providers from charging a joint providership fee.

COMPLIANCE AND NONCOMPLIANCE ISSUES

The ACCME expects all CME activities to be in compliance with the accreditation requirements. In cases of joint providership, it is the ACCME accredited provider’s responsibility to be able to demonstrate through written documentation this compliance to the ACCME. Materials submitted that demonstrate compliance may be from either the ACCME accredited provider’s files or those of the nonaccredited provider.

PROVIDERS ON PROBATION

If a provider is placed on Probation, it may not jointly provide CME activities with nonaccredited providers, with the exception of those activities that were contracted prior to the Probation decision. A provider that is placed on Probation must inform the ACCME of all existing joint providership relationships, and must notify its current contracted joint providers of its probationary status.

Providers that receive a decision of Probation in two consecutive accreditation terms are prohibited from jointly providing activities until they regain their accreditation status. If the provider is found to be working in joint providership while under this probation, the ACCME will immediately change the provider's status to Nonaccreditation.

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POLICIES SUPPLEMENTING THE STANDARDS FOR COMMERCIAL SUPPORT

COMMERCIAL EXHIBITS AND ADVERTISEMENTS

Commercial exhibits and advertisements are promotional activities and not continuing medical education. Therefore, monies paid by commercial interests to providers for these promotional activities are not considered to be commercial support. However, accredited providers are expected to fulfill the requirements of SCS 4 and to use sound fiscal and business practices with respect to promotional activities.

COMMERCIAL SUPPORT: ACKNOWLEDGMENTS

The provider’s acknowledgment of commercial support as required by SCS 6.3 and 6.4 may state the name, mission, and areas of clinical involvement of an ACCME-defined commercial interest but may not include corporate logos and slogans.

COMMERCIAL SUPPORT: DEFINITION AND GUIDANCE REGARDING WRITTEN

AGREEMENTS

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.

When there is commercial support there must be a written agreement that is signed by the commercial interest and the accredited provider prior to the activity taking place.

An accredited provider can fulfill the expectations of SCS 3.4 - 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.

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 accreditation requirements.

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DEFINITION OF A COMMERCIAL INTEREST

A commercial interest is 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 - unless the provider of clinical service is owned, or controlled by, an ACCME-defined commercial interest.

A commercial interest is not eligible for ACCME accreditation. Commercial interests cannot be accredited providers and cannot be joint providers. Within the context of this definition and limitation, the ACCME considers the following types of organizations to be eligible for accreditation and free to control the content of CME:

• 501-C Non-profit organizations (Note, ACCME screens 501c organizations for eligibility. Thosethat advocate for commercial interests as a 501c organization are not eligible for accreditation inthe ACCME system. They cannot serve in the role of joint provider, but they can be a commercialsupporter.)

• Government organizations• Non-health care related companies• Liability insurance providers• Health insurance providers• Group medical practices• For-profit hospitals• For profit rehabilitation centers• For-profit nursing homes• Blood banks• Diagnostic laboratories

ACCME reserves the right to modify this definition and this list of eligible organizations from time to time without notice.

DISCLOSURE OF FINANCIAL RELATIONSHIPS TO THE ACCREDITED PROVIDER

Individuals need to disclose relationships with a commercial interest if both (a) the relationship is financial and occurred within the past 12 months and (b) the individual has the opportunity to affect the content of CME about the products or services of that commercial interest.

FINANCIAL RELATIONSHIPS AND CONFLICTS OF INTEREST

Financial relationships are those relationships in which the individual benefits by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria for promotional speakers’ bureau, ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit. Financial benefits are usually associated with roles such as employment, management position, independent contractor (including contracted research), consulting, speaking and teaching, membership on advisory committees or review panels, board membership, and other activities from which remuneration is received, or expected. ACCME considers relationships of the person involved in the CME activity to include financial relationships of a spouse or partner.

The ACCME has not set a minimum dollar amount for relationships to be significant. Inherent in any amount is the incentive to maintain or increase the value of the relationship.

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With respect to personal financial relationships, contracted research includes research funding where the institution gets the grant and manages the funds and the person is the principal or named investigator on the grant.

Conflict of Interest: Circumstances create a conflict of interest when an individual has an opportunity to affect CME content about products or services of a commercial interest with which he/she has a financial relationship.

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. The ACCME considers “content of CME about the products or services of that commercial interest” to include content about specific agents/devices, but not necessarily about the class of agents/devices, and not necessarily content about the whole disease class in which those agents/devices are used.

With respect to financial relationships with commercial interests, when a person divests themselves of a relationship it is immediately not relevant to conflicts of interest but it must be disclosed to the learners for 12 months.

VERBAL DISCLOSURE TO LEARNERS

Disclosure of information about relevant financial relationships may be disclosed verbally to participants at a CME activity. When such information is disclosed verbally at a CME activity, providers must be able to supply the ACCME with written verification that appropriate verbal disclosure occurred at the activity. With respect to this written verification:

1. A representative of the provider who was in attendance at the time of the verbal disclosure mustattest, in writing:

a. that verbal disclosure did occur; andb. itemize the content of the disclosed information (SCS 6.1); or that there was nothing to

disclose (SCS 6.2).2. The documentation that verifies that adequate verbal disclosure did occur must be completed

within one month of the activity.

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The AMA Physician’s Recognition Award and credit system

2017 revision

Information for accredited providers and physicians

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Effective Sept. 29, 2017 General—the 2017 update includes modifications to American Medical Association requirements for accredited CME providers to certify activities for AMA PRA Category 1 Credit™ as part of the AMA/ACCME and alignment process. (pages 4–8)

Other parts of the booklet are due to be updated by the end of 2018.

Core requirements—are now aligned with ACCME accreditation criteria and do not represent anything new for CME providers. (page 4)

Learning formats—have been simpli-fied and now include an “Other activity” format for activities that meet core and credit requirements but do not fit within one of the previously existing formats. (pages 4–5)

Credit requirements—stay the same but have moved to a separate section. (pages 5–6)

More information about the simplifica-tion and alignment process can be found on the AMA website at ama-assn.org/ education/cme-provider-resources.

Modifications in the 2017 revision

17-148701:PDF:9/17:df

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Table of contentsIntroduction

The American Medical Association Physician's Recognition Award and continuing medical education credit system

BRIEF HISTORY ......................................................................................................................................................................... 1

ETHICAL UNDERPINNINGS OF CME ......................................................................................................................................... 2

AMA DEFINITION OF CME ........................................................................................................................................................ 2

EDUCATIONAL CONTENT OF CERTIFIED CME ......................................................................................................................... 2

ACTIVITIES INELIGIBLE FOR AMA PRA CREDIT ....................................................................................................................... 2

CATEGORIES OF AMA PRA CREDIT .......................................................................................................................................... 3

ELIGIBILITY FOR AMA PRA CREDIT ......................................................................................................................................... 3

AMA MONITORING OF ACCREDITED CME PROVIDERS ........................................................................................................... 3

WITHDRAWAL OF PRIVILEGE TO DESIGNATE CREDIT ............................................................................................................ 3

Requirements for educational activities eligible for AMA PRA Category 1 Credit™

Certification of activities for AMA PRA Category 1 Credit™ by accredited CME providers

CORE REQUIREMENTS FOR CERTIFYING EDUCATIONAL ACTIVITIES FOR AMA PRA CATEGORY 1 CREDIT ™ .................... 4

FORMAT-SPECIFIC REQUIREMENTS FOR CERTIFYING ACTIVITIES FOR AMA PRA CATEGORY 1 CREDIT™ ........................ 4

Live activities ..................................................................................................................................................................................................................... 4Enduring materials .......................................................................................................................................................................................................... 4Journal-based CME .......................................................................................................................................................................................................... 4Test item writing ............................................................................................................................................................................................................... 4Manuscript review ........................................................................................................................................................................................................... 4Performance improvement continuing medical education (PI CME) ........................................................................................................... 4Internet point of care (POC) learning ........................................................................................................................................................................ 5Other ..................................................................................................................................................................................................................................... 5

DESIGNATING AND AWARDING AMA PRA CATEGORY 1 CREDIT™....................................................................................... 5

Every activity ...................................................................................................................................................................................................................... 5Live activity ......................................................................................................................................................................................................................... 5Enduring material ............................................................................................................................................................................................................ 6Journal-based CME activity .......................................................................................................................................................................................... 6Test item writing activity ............................................................................................................................................................................................... 6Manuscript review activity ............................................................................................................................................................................................ 6PI CME activity ................................................................................................................................................................................................................... 6Internet point-of-care activity ..................................................................................................................................................................................... 6Other activity ..................................................................................................................................................................................................................... 6

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Additional Information for accredited CME providers

DESIGNATION OF NEW PROCEDURES AND SKILLS TRAINING ............................................................................................... 7

AMA CREDIT DESIGNATION STATEMENT ................................................................................................................................ 7

USE OF PHRASE “AMA PRA CATEGORY 1 CREDIT™” ................................................................................................................. 7

USE OF THE AMA CREDIT DESIGNATION STATEMENT IN PROGRAM MATERIALS AND ACTIVITY ANNOUNCEMENTS ........ 7

RECORDING CREDIT ................................................................................................................................................................. 8

CREDIT CERTIFICATES, TRANSCRIPTS OR OTHER DOCUMENTATION AVAILABLE TO PHYSICIANS ...................................... 8

CREDIT CERTIFICATES, TRANSCRIPTS OR OTHER DOCUMENTATION AVAILABLE TO NON-PHYSICIAN PARTICIPANTS ..... 8

JOINT AND CO-PROVIDERSHIP ................................................................................................................................................ 8

Additional ways for physicians to earn AMA PRA credit and the AMA Physician's Recognition Award

Activities for which AMA PRA Category 1 Credit™ is awarded directly by the AMA

TEACHING AT A LIVE ACTIVITY ................................................................................................................................................ 9

PUBLISHING ARTICLES ............................................................................................................................................................ 9

POSTER PRESENTATIONS ......................................................................................................................................................... 9

MEDICALLY RELATED ADVANCED DEGREES ........................................................................................................................... 9

ABMS MEMBER BOARD CERTIFICATION AND MAINTENANCE OF CERTIFICATION ............................................................... 9

ACCREDITATION COUNCIL FOR GRADUATE MEDICAL EDUCATION ACCREDITED EDUCATION ............................................ 9

International activities for AMA PRA Category 1 Credit™

AMA INTERNATIONAL CONFERENCE RECOGNITION (ICR) PROGRAM ................................................................................. 10

AMA PRA CREDIT SYSTEM INTERNATIONAL AGREEMENTS FOR CREDIT CONVERSION ..................................................... 10

Requirements for AMA PRA Category 2 Credit™

CLAIMING AMA PRA CATEGORY 2 CREDIT™ ....................................................................................................................... 10

The AMA Physician’s Recognition Award

PROFESSIONAL RECOGNITION OF ACCOMPLISHMENTS IN CME ......................................................................................... 11

AMA PRA REQUIREMENTS ..................................................................................................................................................... 11

Eligibility ............................................................................................................................................................................................................................11Credit requirements for the AMA PRA ....................................................................................................................................................................11Award duration ...............................................................................................................................................................................................................11Activity-specific credit limits for the AMA PRA ....................................................................................................................................................12Other types of credit that may be used for the AMA PRA ...............................................................................................................................12

AMA PRA AGREEMENTS WITH OTHER ORGANIZATIONS ..................................................................................................... 12

JURISDICTIONS THAT ACCEPT THE AMA PRA CERTIFICATE FOR LICENSING PURPOSES ................................................... 12

THE JOINT COMMISSION COMPLIANCE ................................................................................................................................ 12

DISCLAIMER ........................................................................................................................................................................... 12

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The American Medical Association Physician’s Recognition Award and continuing medical education credit systemThis document describes the requirements that must be followed by accredited continuing medical education (CME) providers in order to certify activities for AMA PRA Category 1 Credit™ and award credit to physicians. It also describes AMA PRA Category 2 Credit™, requirements for physicians wishing to obtain the American Medical Association (AMA) Physician’s Recognition Award (PRA) and other important related information. The AMA PRA has recognized physician participation in CME for more than 40 years. AMA PRA credit is recognized and accepted by hospital credentialing bodies, state medical licensure boards and medical specialty certifying boards, as well as other organizations.

Brief historyThe AMA was founded by Dr. Nathan Davis, in 1847 in Philadelphia. The first two committees constituted by the new organization were the Committee on Medical Education and the Committee on Ethics, emphasizing the importance the association and the medical profession placed on these two areas. The AMA reorganized in 1901 at which time the Commit-tee on Medical Education became the AMA Council on Medical Education as it continues to be known today. This elected body of physicians formulates policy on medical education by mak-ing recommendations to the AMA House of Delegates (HOD) through the AMA Board of Trustees.

Due to the state of undergraduate and graduate education at the time, the organization’s early efforts focused primarily on these areas. A major accomplishment of the AMA Council on Medical Education in its early history was laying much of the ground work for, and participating in, the Carnegie Foundation for the Advancement of Teaching’s national study of existing medical schools. The study began in 1909 and resulted in what is known today as the "Flexner Report," named for its author, Abraham Flexner of the Carnegie Foundation. N. P. Colwell, MD, secretary to the Council on Medical Education, and Arthur D. Bevan, MD, chairman of the Council on Medical Education, were major contributors to the work that went into the report. This report had a major effect on the medical school education of physicians and essentially established the model for medical education in the United States until the present, more than 100 years later.

In the 1940s and 1950s the AMA Council on Medical Educa-tion increased its focus on postgraduate medical education (PGME). The AMA surveyed practicing physicians to determine how many of them participated in PGME after completion of residency and/or pursued self-directed learning. The council re-ported to the AMA-HOD in 1955 that almost a third of the 5,000 physicians responding to this survey reported no participation in formal PGME for at least the past five years. The AMA Coun-cil on Medical Education declared that PGME (later changed to “continuing” medical education by the AMA-HOD) “lacked direction and was suffering from a lack of clearly defined objec-tives.” As a result of the report, the AMA-HOD took many actions to support CME in the 1960s, one of which was to establish a standing Advisory Committee on Continuing Medical Educa-tion which, by 1967, had developed a nationwide accreditation system for CME providers. In 1968 the AMA established the AMA PRA. The related AMA PRA credit system for physicians was developed as the metric to be used in determining qualifi-cations for the AMA PRA.

Over the next two decades the AMA created other entities to make accreditation decisions. In 1981 the AMA and six other national organizations formed the Accreditation Council for Continuing Medical Education (ACCME). The seven member organizations of the ACCME are: the AMA, American Board of Medical Specialties, American Hospital Association, Association for Hospital Medical Education, Association of American Medi-cal Colleges, Council of Medical Specialty Societies and the

The AMA PRA program continually evolves to meet physicians’ learning needs. The AMA Council on Medical Education welcomes input from physicians, accredited CME providers, and consumers of CME credit on recommendations for revisions and/or additions to the AMA PRA credit system. These recommendations should be communicated to the AMA Division of Continuing Physician Professional Development (CPPD). We would like to thank the accredited CME provider and physician communities, without whom the changes and improvements reflected in this booklet would not have been possible, and the patients who lend meaning to this work.

In support of the AMA PRA and the credit system, staff from the AMA Division of CPPD is available to answer questions from physi-cians, accredited CME providers or the public about compliance with the AMA PRA requirements, standards and policies. Questions may be directed to [email protected]. Resources are also available on the “AMA PRA Credit System” web page. Anyone who is involved in planning or implementing CME activities is encouraged to subscribe, free of charge, to the AMA MedEd Update monthly email newsletter.

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Federation of State Medical Boards.

Within the United States, the AMA only authorizes organiza-tions that are accredited by the ACCME or by a state medical so-ciety recognized by the ACCME, referred to as “accredited CME providers,” to designate and award AMA PRA Category 1 Credit™ to physicians. With the exception of those activities directly certified by the AMA, individual educational activities must be offered only by accredited CME providers, in accordance with AMA PRA credit system requirements, to be certified for AMA PRA Category 1 Credit™. The AMA, on behalf of its physician constituency, also maintains international relationships for certain educational activities that meet AMA standards.

Ethical underpinnings of CME The AMA Principles of Medical Ethics, which are part of the more extensive AMA Code of Medical Ethics (Code), are stan-dards of conduct that define the essentials of honorable physician behavior. These ethical statements were developed primarily for the benefit of the patient and recognize the physi-cian’s responsibility to patients first and foremost, as well as to society, to other health professionals and to him/herself.

Recognizing the central role of education for the continuing professional development of physicians, Principle V of the Code provides the grounding tenet for CME and medical education, in general:

Principle V. A physician shall continue to study, ap-ply, and advance scientific knowledge, maintain a commitment to medical education, make relevant information available to patients, colleagues, and the public, obtain consultation, and use the talents of other health professionals when indicated.

In addition, physicians have certain ethical responsibilities when participating in CME activities, either as a learner, faculty or planner. Accredited CME providers are encouraged to be fa-miliar with the relevant ethical issues for physicians and ensure that participation in certified CME activities will not encourage or require physicians to violate the AMA ethical guidance. As of the time of this writing, the ethical opinions relevant to CME include 9.2.6 “Continuing Medical Education”, 9.2.7 “Financial Relationships with Industry in Continuing Medical Education,” and 9.6.2 “Gifts to Physicians from Industry,” which can be found in full in the AMA Code of Medical Ethics. Questions regarding the interpretation of these opinions should be addressed to [email protected].

The AMA expects accredited CME providers to present physi-cians with commercially unbiased, independent and objective information in all of their activities. Accredited providers must be in compliance with the ACCME Standards for Commercial SupportSM.

AMA definition of CMEThe AMA-HOD and the AMA Council on Medical Education have defined continuing medical education as follows:

CME consists of educational activities which serve to maintain, develop, or increase the knowledge, skills, and professional performance and relation-ships that a physician uses to provide services for patients, the public or the profession. The content of CME is the body of knowledge and skills gener-ally recognized and accepted by the profession as within the basic medical sciences, the discipline of clinical medicine and the provision of health care to the public. (HOD policy #300.988)

Educational content of certified CMECertified CME is defined as:

1. Nonpromotional learning activities certified for credit prior to the activity by an organization authorized by the credit system owner, or

2. Nonpromotional learning activities for which the credit system owner directly awards credit

Accredited CME providers may certify nonclinical subjects (e.g., office management, patient-physician communications, faculty development) for AMA PRA Category 1 Credit™ as long as these are appropriate to a physician audience and benefit the profession, patient care or public health.

CME activities may describe or explain complementary and alternative health care practices. As with any CME activity, these need to include discussion of the existing level of scientific evidence that supports the practices. However, education that advocates specific alternative therapies or teaches how to perform associated procedures, without scientific evidence or general acceptance among the profession that supports their efficacy and safety, cannot be certified for AMA PRA Category 1 Credit™.

Activities ineligible for AMA PRA credit CME credit may not be claimed for learning which is incidental to the regular professional activities or practice of a physician, such as learning that occurs from:

• Clinical experience

• Charity or mission work

• Mentoring

• Surveying

• Serving on a committee, council, task force, board, house of delegates or other professional workgroup

• Passing examinations that are not integrated with a certi-fied activity

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Categories of AMA PRA creditThere are two categories of AMA PRA credit: AMA PRA Category 1 Credit™ and AMA PRA Category 2 Credit™.

EARNING AMA PRA CATEGORY 1 CREDIT™

There are three ways for physicians to earn AMA PRA Category 1 Credit™.

1. By participating in certified activities sponsored by ac-credited ACCME or SMS CME providers. Information for accredited CME providers to certify activities for AMA PRA Category 1 Credit™ can be found on pages 4–8 and on the “AMA PRA Credit System” web page.

2. By participating in activities recognized by the AMA as valid educational activities. Information about these activi-ties can be found on page 9 and on the “Claim CME Credit From the AMA” web page.

3. By participating in certain international activities recog-nized by the AMA. Information regarding these activities can be found on page 10 and on the “Earn Credit for Participation in International Activities” web page.

EARNING AMA PRA CATEGORY 2 CREDIT™

AMA PRA Category 2 Credit™ is self-claimed and documented by physicians for participating in activities that are not certified for AMA PRA Category 1 Credit™. More information about AMA PRA Category 2 Credit™ can be found on page 10 of this booklet.

Eligibility for AMA PRA creditAMA PRA credit may only be claimed by, and awarded to, physi-cians, defined by the AMA as individuals who have completed an allopathic (MD), osteopathic (DO) or an equivalent medical degree from another country.

AMA monitoring of accredited CME providersTo assure the integrity of the AMA PRA credit system, the AMA monitors for compliance with AMA PRA credit system requirements in several ways including through the ACCME ac-creditation self-study process, the investigation of complaints received and the review of information found in the public domain. Whenever warranted, the AMA will proceed with follow-up inquiries to ascertain and address compliance with AMA PRA credit system requirements. In most cases, the AMA is able to assist accredited CME providers with finding strate-gies that will bring their program and activities into compliance with AMA PRA standards.

Withdrawal of privilege to designate creditThe AMA reserves the right to withdraw an accredited CME provider’s privilege to certify activities for AMA PRA Category 1 Credit™ should the accredited CME provider fail to bring the program and activities into compliance with AMA PRA policies, regardless of accreditation status. Accredited CME providers have appropriate recourse through a due process system that has been established for the investigation of any issue related to the AMA PRA requirements. Information about this process can be found on the “Procedures for Handling Complaints Regarding AMA PRA Credit” web page.

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Requirements for educational activities eligible for AMA PRA Category 1 Credit™

Certification of activities for AMA PRA Category 1 Credit™ by accredited CME providers Accredited CME providers must ensure that activities certified for AMA PRA Category 1 Credit™ meet all AMA requirements, which include core requirements, format-specific requirements, and requirements for designating and awarding AMA PRA Category 1 Credit™.

Core requirements for certifying activities for AMA PRA Category 1 Credit™1. The CME activity must conform to the AMA/ACCME

definition of CME.

2. The CME activity must address an educational need (knowledge, competence or performance) that underlies the professional practice gaps of that activity’s learners.

3. The CME activity must present content appropriate in depth and scope for the intended physician learners.

4. When appropriate to the activity and the learners, the accredited provider should communicate the identified educational purpose and/or objectives for the activity, and provide clear instructions on how to successfully complete the activity.

5. The CME activity must utilize one or more learning methodologies appropriate to the activity’s educational purpose and/or objectives.

6. The CME activity must provide an assessment of the learner that measures achievement of the educational purpose and/or objective of the activity.

7. The CME activity must be planned and implemented in accordance with the ACCME Standards for Commercial Support: Standards to Ensure Independence in CME ActivitiesSM.

Format-specific requirements for certifying activities for AMA PRA Category 1 Credit™Activities may be held in one or more of the formats described below, and the applicable format requirements must be met.

LIVE ACTIVITIES

An activity that occurs at a specific time as scheduled by the accredited CME provider. Participation may be in person or remotely as is the case of teleconferences or live internet webinars.

ENDURING MATERIALS

An activity that endures over a specified time and does not have a specific time or location designated for participation, rather, the participant determines whether and when to com-plete the activity. (Examples: online interactive educational module, recorded presentation, podcast.)

• Provide access to appropriate bibliographic sources to allow for further study.

JOURNAL-BASED CME

An activity that is planned and presented by an accredited provider and in which the learner reads one or more articles (or adapted formats for special needs) from a peer-reviewed, professional journal.

• Be a peer–reviewed article.

TEST ITEM WRITING

An activity wherein physicians learn through their contribution to the development of examinations or certain peer-reviewed self-assessment activities by researching, drafting and defending potential test items.

MANUSCRIPT REVIEW

An activity in which a learner participates in the critical review of an assigned journal manuscript during the pre-publication review process of a journal.

PERFORMANCE IMPROVEMENT CONTINUING MEDICAL EDUCATION (PI CME)

An activity structured as a three-stage process by which a physician or group of physicians learn about specific per-formance measures, assess their practice using the selected performance measures, implement interventions to improve performance related to these measures over a useful interval of time, and then reassess their practice using the same performance measures.

• Have an oversight mechanism that assures content integrity of the selected performance measures. If appropriate, these measures should be evidence- based and well designed.

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• Provide clear instruction to the physician that defines the educational process of the activity (documentation, timeline).

• Provide adequate background information so that physicians can identify and understand the performance measures that will guide their activity and the evidence behind those measures (if applicable).

• Validate the depth of physician participation by a review of submitted PI CME activity documentation.

• Consist of the following three stages:

Stage A—learning from current practice performance assessment. Assess current practice using the identi-fied performance measures, either through chart reviews or some other appropriate mechanism.

Stage B—learning from the application of PI to patient care. Implement the intervention(s) based on the results of the analysis, using suitable tracking tools. Participating physicians should receive guid-ance on appropriate parameters for applying the intervention(s).

Stage C—learning from the evaluation of the PI CME effort. Reassess and reflect on performance in

practice measured after the implementation of the intervention(s), by comparing to the original assess-ment and using the same performance measures. Summarize any practice, process and/or outcome changes that resulted from conducting the PI CME activity.

INTERNET POINT-OF-CARE (POC) LEARNING

An activity in which a physician engages in self-directed, online learning on topics relevant to their clinical practice from a database whose content has been vetted by an accredited CME provider.

OTHER

Accredited CME providers can introduce new instructional practices, as well as blend new and/or established learning formats appropriate to their learners and setting, as long as the activity meets all core requirements. Certified CME activities that do not fit within one of the established format categories must identify the learning format as “Other activity”, followed by a short description of the activity in parentheses, in both the AMA Credit Designation Statement and on documentation provided to learners (certificates, transcripts, etc.). See page 7, “AMA Credit Designation Statement” for additional information.

Designating and awarding AMA PRA Category 1 Credit™

EVERY ACTIVITY (regardless of format)

• Must comply with the seven core requirements.

• Must comply with the format-specific requirements, if any.

• Must be certified for AMA PRA Category 1 Credit™ in advance of the activity; i.e., an activity may not be retroactively approved for credit.

• Must include the AMA Credit Designation Statement in activity materials that reference CME credit.

• Must have the credits claimed by physicians retained by the accredited CME provider for a minimum of six years.

LIVE ACTIVITY

• Credit for a live activity is determined by measuring for-mal interaction time between faculty and the physician audience; 60 minutes equals one (1) AMA PRA Category 1 Credit™; credit is designated in 15 minute or 0.25 credit increments and rounded to the nearest quarter hour.

• Physicians claim credit based on participation time, rounded to the nearest quarter hour; this is the number of credits awarded.

• When concurrent sessions are offered in a live activity the time is only counted once—i.e., the designated maximum amount of credit may not exceed that which could be claimed by an individual physician.

• Only segments of the activity that comply with the AMA core requirements may be certified for AMA PRA Category 1 Credit™ and included in the designated maximum for the activity. Certified segments must be clearly identified in activity materials.

Faculty credit for learning associated with preparing and presenting an original presentation

Accredited CME providers may also award AMA PRA Category 1 Credit™ to their physician faculty to recognize the learning associated with the preparation and teaching of an original presentation at the accredited CME provider’s live activities that are certified for AMA PRA Category 1 Credit™.

Credit for faculty is calculated on a 2-to-1 ratio to presentation time, rounded to the nearest quarter credit.

• Credit may only be claimed once for an original presenta-tion; credit may not be claimed for subsequent presenta-tions of the same material.

• Physician faculty may not claim credit as a participant for their own presentations, but may claim credit for other segments they attend as a participant.

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Faculty credit for learning that takes place while preparing to teach and then is used in teaching medical students and/or residents

Accredited CME providers that are also accredited by either the LCME (for faculty teaching medical students) and/or the ACGME (for faculty teaching residents/fellows) are eligible to certify a live activity that recognizes the learning associated with teaching medical students and residents. Organiza-tions that are LCME- and/or ACGME-accredited may work in a joint-providership relationship with a CME provider accredited through the ACCME system to certify this type of live activity for AMA PRA Category 1 Credit™.

• Credit for faculty is calculated on a 2-to-1 ratio to time spent teaching based on what was learned in preparation for it, rounded to the nearest quarter credit.

• Credit should only be awarded for teaching that is verified by the UME and/or GME office.

• In addition to the institution being ACGME accredited, the residency/fellowship program itself must also be ACGME accredited in order for faculty to be awarded AMA PRA Category 1 Credit™ for teaching residents/fellows in that program.

ENDURING MATERIAL

• Credit is designated based on the average time it would take a small sample group of the target audience to com-plete the material. Accredited CME providers can use other mechanisms to establish credit if the result is the same. Credit is designated in 15 minute or 0.25 credit increments and rounded to the nearest quarter hour.

• Physicians who successfully complete the activity are awarded the number of credits for which the activity is designated.

JOURNAL-BASED CME ACTIVITY

• Individual articles are designated for, and physicians are awarded, one (1) AMA PRA Category 1 Credit™.

TEST-ITEM WRITING ACTIVITY

• Each test-item writing activity is designated for, and physi-cians are awarded, ten (10) AMA PRA Category 1 Credits™.

MANUSCRIPT REVIEW ACTIVITY

• Each manuscript review is designated for, and physicians are awarded, three (3) AMA PRA Category 1 Credits™.

PI CME ACTIVITY

• Each PI CME activity is designated for twenty (20) AMA PRA Category 1 Credits™.

• Physicians completing Stage A are awarded five (5) AMA PRA Category 1 Credits™; Stages A and B, 10 credits; A, B and C, 20 credits.

INTERNET POINT-OF-CARE ACTIVITY

• Each Internet PoC search is designated for, and physicians are awarded, one-half (0.5) AMA PRA Category 1 Credit™.

OTHER ACTIVITY

Accredited CME providers designate AMA PRA Category 1 Credit™ on a one credit-per-hour basis, using their best reason-able estimate of the time required to complete the activity. Physicians are awarded the number of credits for which the activity is designated.

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Additional information for accredited CME providers

Designation of new procedures and skills training Through new procedures and skills courses, accredited CME providers can train physicians on topics that may allow them to request new or expanded clinical privileges. The AMA PRA requirements for new skills and procedures training consist of four levels so that accredited CME providers and physicians can clearly identify the depth and complexity of the training. Accredited CME providers will need to assess, at the activity’s conclusion, the participant physician’s level of achievement. This is in addition to planning and implementing the activi-ties to meet the AMA core requirements, the format-specific requirements for the activity and the requirements for designating and awarding AMA PRA Category 1 Credit™, to be certified for AMA PRA Category 1 Credit™. The requirements for designation of new procedures and skills training and the certificate wording for each of the levels may be found on the AMA website.

AMA Credit Designation Statement The AMA Credit Designation Statement indicates to physicians that the activity has been certified by an accredited CME pro-vider as being in compliance with AMA PRA Category 1 Credit™ requirements. The AMA Credit Designation Statement must be written without paraphrasing and must be listed separately from accreditation or other statements.

The following AMA Credit Designation Statement must be included in relevant announcement and activity materials:

The <<name of accredited CME provider>> designates this <<learning format>> for a maximum of <<number of credits>> AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

The learning format listed in the AMA Credit Designation Statement must be one of the following AMA approved learning formats:

1. Live activity

2. Enduring material

3. Journal-based CME activity

4. Test-item writing activity

5. Manuscript review activity

6. PI CME activity

7. Internet point-of-care activity

8. Other activity (<<provide short description>>)

For activities in the “Other activity” format:

The <<name of accredited CME provider>> designates this Other activity (<<provide short description>>) for a maximum of <<number of credits>> AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Due to the nature of faculty credit for teaching medical stu-dents and residents/fellows, the standard credit designation statement listed above is not appropriate for this type of live activity since the number of credits will not be known in advance. The following credit designation statement should be used in its place for faculty credit for teaching medical students and residents/fellows only:

The <<name of accredited CME provider>> designates this live activity for a maximum of 2 AMA PRA Category 1 Credits™ per one hour of interaction with medical students and/or residents/fellows. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Use of phrase “AMA PRA Category 1 Credit™” The phrase “AMA PRA Category 1 Credit” is a trademark of the American Medical Association. Accredited CME providers must always use the complete italicized, trademarked phrase. The phrase “Category 1 Credit” cannot be used when referring to AMA PRA Category 1 Credit™.

Use of the AMA Credit Designation Statement in program materials and activity announcements

PROGRAM MATERIALS

The AMA Credit Designation Statement must be used in any program materials, in both print and electronic formats (e.g., a course syllabus, enduring material publication, landing page of an internet activity), that reference CME credit.

ACTIVITY ANNOUNCEMENTS

Activity announcements include all materials, in both print and electronic formats, that are designed to build awareness of the activity’s educational content among the target physician audi-ence. The complete AMA Credit Designation Statement must always be used on any document or publication that references the number of AMA PRA Category 1 Credits™ designated for the activity.

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A “Save the date” announcement (such as a postal mailer with limited space) may indicate that the activity has been ap-proved for AMA PRA Category 1 Credit™ without stating an exact number of credits if the accredited CME provider has already certified the activity. This announcement may read, “This activity has been approved for AMA PRA Category 1 Credit™” or similar language. Accredited CME providers may never indicate that “AMA PRA Category 1 Credit™ has been applied for” or any similar wording.

Recording credit Accredited CME providers must have a mechanism for physi-cians to claim credit and must award the actual number of AMA PRA Category 1 Credits™ claimed by each physician. The records documenting the credit awarded must be retained by accred-ited CME providers, for each certified activity, for a minimum of six years after the completion date of the activity.

Although it is necessary to uniquely identify the physicians who claim CME credit, AMA House of Delegates policy opposes the use of Social Security numbers to do so. An alternative that might be used is the physician’s Medical Education number, a unique 11-digit proprietary identifier assigned by the AMA to every U.S. physician.

Credit certificates, transcripts or other documentation available to physicians Only physicians (MDs, DOs and those with equivalent medical degrees from another country) may be awarded AMA PRA Cat-egory 1 Credit™ by accredited CME providers. Accredited CME providers must be able to provide documentation to participat-ing physicians of the credit awarded upon the request of the physician. When an accredited CME provider issues a certificate, transcript or another means of documentation, it must reflect the actual number of credits claimed by the physician. An ex-ample of wording that might be used on certificates awarding AMA PRA Category 1 Credit™ to physicians follows:

The <<name of accredited CME provider>> certifies that <<name of physician>> <<degree>> has participated in the <<learning format>> titled <<title of activity>> on <<date>> and is awarded <<number of credits>> AMA PRA Category 1 Credit(s)™.

Documentation provided to participating physicians must ac-curately reflect, at a minimum, the following:

• Physician’s name

• Name of accredited CME provider

• Title of activity

• Learning format

• Date(s) of live activity or date that physician completed the activity

• Number of AMA PRA Category 1 Credits™ awarded

Credit certificates, transcripts or other documentation available to non-physician participants Non-physician health professionals and other participants may not be awarded AMA PRA Category 1 Credit™. However, ac-credited CME providers may choose to issue documentation of participation to non-physicians that states that the activity was certified for AMA PRA Category 1 Credit™. An example of word-ing that might be used on documentation for a non-physician participant follows:

The <<name of accredited CME provider>> certifies that <<name of non-physician participant>> has participated in the <<learning format>> titled <<title of activity>> on <<date>>. This activity was designated for <<number of credits>> AMA PRA Category 1 Credit(s)™.

Joint and co-providership If a certified activity is either jointly provided (by an accredited CME provider and a non-accredited organization) or co-provid-ed (by two or more accredited CME providers), then the accred-ited CME provider certifying the activity must keep a record of the AMA PRA Category 1 Credit™ claimed for each physician participating in that activity.

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Additional ways for physicians to earn AMA PRA credit and the AMA Physician's Recognition Award

Activities for which AMA PRA Category 1 Credit™ is awarded directly by the AMASome activities do not occur under the auspices of an accred-ited CME provider. The AMA Council on Medical Education recognizes the learning that occurs in completing these activi-ties and allows physicians to claim AMA PRA Category 1 Credit™ directly from the AMA for the activities defined in this section.

To claim credit for these activities the physician should apply to the AMA for a certificate indicating the AMA PRA Category 1 Credit™ awarded for completion of each activity. Information and the direct credit application can be found on the “Claim CME Credit From the AMA” web page. These activities include:

Teaching at a live activityPreparing and presenting an original presentation at a live activity that has been certified for AMA PRA Category 1 Credit™ (if the accredited CME provider has not already awarded credit for this).

Documentation: a copy of the page(s) used by the provider to announce or describe the activity which includes the name of the speaker, accredited CME provider, AMA Credit Designation Statement, date and location of the activity.

Credit assignment: two (2) AMA PRA Category 1 Credits™ per one (1) hour of presentation time.

Publishing articlesPublishing, as the lead author (first listed), a peer-reviewed article in a journal included in the MEDLINE bibliographic database.

Documentation: a reprint or copy of the page(s) of the journal, which include the name of the author listed first, the name of the journal and date published.

Credit assignment: ten (10) AMA PRA Category 1 Credits™ per article.

Poster presentationsPreparing a poster presentation, as the first author, which is included in the published abstracts, at an activity certified for AMA PRA Category 1 Credit™.

Documentation: a copy of the page(s) in the published activity documents that lists the author and poster abstract, accredited

CME provider, AMA Credit Designation Statement, title and date of activity.

Credit assignment: five (5) AMA PRA Category 1 Credits™ per poster.

Medically related advanced degreesObtaining a medically related advanced degree, such as a masters in public health (not available if the academic program certified individual courses for AMA PRA Category 1 Credit™).

Documentation: a copy of the diploma or final transcript.

Credit assignment: twenty five (25) AMA PRA Category 1 Credits™.

ABMS member board certification and Maintenance of Certification (MoC©)Successfully completing an ABMS board certification or MoC process.

Documentation: a copy of the board certificate or the specialty board notification letter.

Credit assignment: sixty (60) AMA PRA Category 1 Credits™.

Accreditation Council for Graduate Medi-cal Education accredited educationSuccessfully participating in an Accreditation Council for Graduate Medical Education (ACGME) accredited residency or fellowship program.

Documentation: a copy of the certificate or letter of comple-tion from the approved residency/fellowship program

Credit assignment: twenty (20) AMA PRA Category 1 Credits™ per year

The successful completion of an ABMS member board certifica-tion process or an ACGME accredited residency or fellowship program also qualifies a physician for the AMA PRA. Please see the section regarding the AMA PRA or visit the “Apply for the AMA Physician Recognition Award” web page.

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International activities for AMA PRA Category 1 Credit™For participation in certain international activities, physicians may earn AMA PRA Category 1 Credit™.

AMA international conference recognition program Each year the AMA recognizes and provides physicians with an opportunity to earn AMA PRA Category 1 Credit™ for certain international conferences. Contact [email protected] learn out if there are any upcoming approved conferences.

AMA PRA credit system international agreements for credit conversionAs of this writing, the AMA has agreements with the European Union of Medical Specialists, the Royal College of Physicians and Surgeons of Canada, and the Qatar Council for Healthcare Practitioners for the conversion of their CME credit to AMA PRA Category 1 Credit™.

Visit the “Earn Credit for Participation in International Activities” web page for more information.

Requirements for AMA PRA Category 2 Credit™AMA PRA Category 2 Credit™ is self-designated and claimed by individual physicians for participation in activities not certified for AMA PRA Category 1 Credit™ that:

• Comply with the AMA definition of CME; and

• Comply with the relevant AMA ethical opinions; at the time of this writing this includes 8.061 “Gifts to Physicians from Industry” and 9.011 “Continuing Medical Education,” and

• Are not promotional; and

• A physician finds to be a worthwhile learning experience related to his/her practice.

Examples of learning activities that might meet the require-ments for AMA PRA Category 2 Credit™ include, but are not limited to:

• Participation in activities that have not been certified for AMA PRA Category 1 Credit™

• Teaching physicians, residents, medical students or other health professionals

• Unstructured online searching and learning (i.e., not Internet PoC)

• Reading authoritative medical literature

• Consultation with peers and medical experts

• Small group discussions

• Self assessment activities

• Medical writing

• Preceptorship participation

• Research

• Peer review and quality assurance participation

Organizations may not certify activities for AMA PRA Category 2 Credit™ or advertise that an activity qualifies for AMA PRA Category 2 Credit™. Organizations may choose to maintain records of physician participation in activities that have not been certified for AMA PRA Category 1 Credit™ but, since they may not certify or award such credit, should not record them as AMA PRA Category 2 Credit™.

A physician must individually assess the educational value for each learning experience in which he or she participates to determine if it is appropriate to claim AMA PRA Category 2 Credit™.

Claiming AMA PRA Category 2 Credit™Documentation: the physician should self claim credit for ap-propriate AMA PRA Category 2 Credit™ activities and document activity title or description, subject or content area, date(s) of participation and number of credits claimed. Physicians may not claim AMA PRA Category 2 Credit™ for an activity for which the physician has claimed AMA PRA Category 1 Credit™. Each physician is responsible for claiming and maintaining a record of their AMA PRA Category 2 Credit™.

Credit calculation: as with live activities, physicians should claim credit based on their participation time with 60 minutes of participation equal to one (1) AMA PRA Category 2 Credit™; credit is claimed in 15 minute or 0.25 credit increments; physi-cians must round to the nearest quarter hour.

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The AMA Physician’s Recognition Award

Professional recognition of accomplish-ments in CMESince 1968 patients and colleagues have recognized the AMA PRA as evidence of a physician’s commitment to keeping cur-rent with the advances in biomedical science, as well as other developments in medicine. The goals of this award remain the same as established more than 40 years ago:

• To provide recognition for the many thousands of physicians who regularly participate in CME

• To encourage all physicians to keep up-to-date and to improve their knowledge and judgment by CME

• To provide reassurance to the public that America’s physicians are maintaining their competence by regular participation in CME

• To emphasize the AMA’s position as a leader in CME

• To emphasize the importance of developing more mean-ingful continuing education opportunities for physicians

• To strengthen the physician’s position as the leader of the health service team by focusing attention on his or her interest in maintaining professional competence

The AMA encourages all physicians to become involved in a program that honors them as professionals who participate in CME in order to better meet the needs of their patients.

In addition, the AMA PRA is widely accepted by multiple entities as proof of participation in CME. Most state licensing boards and hospitals will accept the AMA PRA or the AMA ap-proved application as proof of having met CME requirements.

AMA PRA requirements

ELIGIBILITY

Physicians may apply for the AMA PRA if they hold a valid and current license issued by one of the United States, Canadian or Mexican licensing jurisdictions, or are engaged in an ACGME-accredited residency training program in the United States.

CREDIT REQUIREMENTS FOR THE AMA PRA

In order to apply for an AMA PRA, physicians must earn a speci-fied number of AMA PRA Category 1 Credits™, either through accredited CME provider certified activities, from the AMA for direct credit activities, or international activities. The rest of the credits required for the award may be either AMA PRA Category 1 Credits™ or AMA PRA Category 2 Credits™.

The AMA offers one-, two- and three-year AMA PRAs. The requirements for each are as follows:

One-year award

• Twenty (20) AMA PRA Category 1 Credits™ and thirty (30) AMA PRA Category 1 Credits™ or AMA PRA Category 2 Credits™ (50 credits total), or

• one year ACGME residency/fellowship training

Two-year award

• Forty (40) AMA PRA Category 1 Credits™ and sixty (60) AMA PRA Category 1 Credits™ or AMA PRA Category 2 Credits™ (100 credits total), or

• two years ACGME residency/fellowship training

Three-year award

• Sixty (60) AMA PRA Category 1 Credits™ and ninety (90) AMA PRA Category 1 Credits™ or AMA PRA Category 2 Credits™ (150 credits total), or

• Three years ACGME residency/fellowship training, or

• ABMS board certification or MoC

The AMA PRA with commendation is available for physicians who meet the following requirements:

One-year award with commendation: ninety (90) credits total

• Sixty (60) AMA PRA Category 1 Credits™ and thirty (30) AMA PRA Category 1 Credits™ or AMA PRA Category 2 Credits™

Two-year award with commendation: one hundred and eighty (180) credits

• One hundred and twenty (120) AMA PRA Category 1 Credits™ and sixty (60) AMA PRA Category 1 Credits™ or AMA PRA Category 2 Credits™

Three-year award with commendation: two hundred and seventy (270) credits

• One hundred and eighty (180) AMA PRA Category 1 Credits™ and ninety (90) AMA PRA Category 1 Credits™ or AMA PRA Category 2 Credits™

The AMA requires that at least half of the credit applied toward the AMA PRA be within the physician’s specialty or area of practice. Ethics, office management and physician-patient communication can serve as appropriate topics for CME, but are not considered specialty specific education.

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AWARD DURATION

The AMA PRA signals a commitment to ongoing participation in CME and acknowledges past participation in CME activities. The AMA grants the award based on the prior one to three years of CME credit attainment. The award’s term begins on the first of the month following the completion date of the latest CME activity listed on the application for which the physician claimed AMA PRA Category 1 Credit™. For example, a physician applying for a three-year award whose last activity was on May 21, 2017, will be issued a certificate valid from June 1, 2017 un-til June 1, 2020. If a physician is renewing his/her AMA PRA the renewal date will be the same as the expiration date of his/her last AMA PRA if he/she earned the allotted credits in the time period of his/her expiring AMA PRA.

ACTIVITY-SPECIFIC CREDIT LIMITS FOR THE AMA PRA

For the purpose of applying for an AMA PRA certificate, certain activities include specific limits on the amount of credit a physician can claim, per year, toward their AMA PRA:

• Teaching at live activities certified for AMA PRA Category 1 Credit™: Limit of ten (10) AMA PRA Category 1 Credits™ per year

• Internet PoC: Limit of twenty (20) AMA PRA Category 1 Credits™ per year

• Manuscript review: Limit of five (5) reviews— or fifteen (15) AMA PRA Category 1 Credits™ per year

• Poster presentation: Limit of one (1) poster— or five (5) AMA PRA Category 1 Credits™ per year

• Publishing articles: Limit of one (1) article— or ten (10) AMA PRA Category 1 Credits™ per year

OTHER TYPES OF CREDIT THAT MAY BE USED FOR THE AMA PRA

For the purpose of obtaining an AMA PRA application physi-cians may identify credit earned within the following CME systems on a one-to-one basis for AMA PRA Category 1 Credit™

• American Academy of Family Physicians’ prescribed credit

• American College of Obstetricians and Gynecologists’ formal learning cognates

AMA PRA agreements with other organizationsThe AMA has agreements with specialty societies, state medical societies, medical staff groups and other organizations whereby an AMA PRA can be issued to any U.S. licensed physician as established by an agreement between the AMA and the organization.

Organizations that are interested in developing a similar agreement should contact the AMA at [email protected].

Jurisdictions that accept the AMA PRA certificate for licensing purposesAll U.S. licensing jurisdictions requiring CME recognize the AMA PRA credit system. Some of these licensure boards will also accept a current and valid AMA PRA or the AMA approved AMA PRA application as documentation of having met their CME requirements.

Information about state CME requirements for license renewal may be found on the website of the Federation of State Medical Boards (fsmb.org). For the most current information, we sug-gest that the particular jurisdiction be contacted directly.

The Joint Commission complianceThe Joint Commission requires that, at hospitals and health care organizations it accredits, physicians with clinical privi-leges document their participation in CME. The Joint Commis-sion will accept, subject to their review, correctly completed AMA PRA applications stamped “approved” by the AMA as documented physician compliance with Joint Commission CME requirements. The Joint Commission requires that physicians conduct at least half of their reported CME in their specialty or area of clinical practice.

DisclaimerPhysicians should note that the AMA PRA does not serve as a direct measure of physician competency and should not be used for that purpose. Physician competency represents the assessment of many complex measures, of which CME partici-pation is only one.

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American Academy of Pediatrics Policy on

Disclosure of Financial Relationships and Resolution of

Conflicts of Interest for AAP CME Activities

Background

In order to support the professional needs of its members, the AAP CME/CPD program develops,

maintains, and improves the competence, skills, and professional performance of pediatricians

and pediatric healthcare professionals by providing quality, relevant, accessible, and effective

educational experiences that address gaps in professional practice. The AAP CME/CPD program

strives to meet the educational needs of pediatricians and pediatric healthcare professionals and

support their lifelong learning with a goal of improving care for children and families. (AAP

CME/CPD Program Mission Statement, May 2015)

The AAP recognizes that there are a variety of financial relationships between individuals and

commercial interests that require review to identify possible conflicts of interest in a CME activity.

This policy is designed to ensure quality, objective, balanced, and scientifically rigorous AAP

provided or jointly provided Continuing Medical Education (CME) activities by identifying and

resolving all potential conflicts of interest prior to the confirmation of service of those in a position

to influence and/or control CME content.

All AAP CME activities will strictly adhere to the Accreditation Council for Continuing Medical

Education (ACCME) Standards for Commercial Support: Standards to Ensure the Independence of

CME Activities. In accordance with these Standards, the following decisions will be made free of

the control of a commercial interest: identification of CME needs, determination of educational

objectives, selection and presentation of content, selection of all persons and organizations that will

be in a position to control the content, selection of educational methods, and evaluation of the CME

activity (ACCME Standard 1.1).

The purpose of this policy and its associated procedures is to ensure all potential conflicts of interest

are identified and mechanisms to resolve them prior to the CME activity are implemented in ways

that are consistent with the public good.

Policy

The ACCME requires accredited CME providers to identify and resolve all potential conflicts of

interest with any individual in a position to influence and/or control the content of CME activities.

A conflict of interest will be considered to exist if the individual has received financial benefits in

any amount from a commercial interest within the past 12 months AND that individual is in a

position to affect the content of CME regarding the products or services of the commercial interest.

As a CME provider accredited by the ACCME, the AAP requires all individuals* in a position to

influence and/or control the content of AAP directly and jointly provided CME activities to disclose

to the AAP and subsequently to learners that the individual either has no relevant financial

relationships or has any relevant financial relationships with the manufacturer(s) of any

commercial product(s) and/or provider(s) of commercial services discussed in CME activities.

Individuals are required to disclose the following information per ACCME Standard 6.1:

name of the individual**

name of the commercial interest(s)***

nature of the financial relationship the individual has with each commercial

interest****

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2

discussion of “off label” use (per AAP policy)

“Disclosure” information provided by all those in a position to influence and/or control CME content

must never include the use of a corporate logo, trade name or a product-group message of an

ACCME-defined commercial interest (ACCME Standard 6.4). Disclosure information must first be

disclosed to AAP staff for determination of potential conflicts of interest. All disclosure information

must be provided to AAP CME activity participants prior to the beginning of the CME activity

(ACCME Standard 6.5).

All potential conflicts of interest identified through the review of AAP Full Disclosure Statement

forms must be resolved in order for individuals in a position to influence and/or control CME

content to be confirmed for the educational assignment. The resolution process and outcomes must

be documented in the CME activity file.

Beyond disclosure of financial relationships, AAP CME faculty and authors are required to disclose

to the AAP and to learners when they plan to discuss or demonstrate pharmaceuticals and/or medical

devices that are not approved by the FDA and/or medical or surgical procedures that involve an

unapproved or “off-label” use of an approved device or pharmaceutical.

The AAP requires that the content of directly and jointly provided CME activities provide balance,

independence, objectivity, and scientific rigor. Planning must be free of the influence or control of a

commercial entity, and promote improvements or quality in healthcare. All recommendations in

CME activities involving clinical medicine must be based on evidence accepted within the medical

profession. The content or format of a CME activity and its related materials must promote

improvements or quality in healthcare and not a specific proprietary business interest of a

commercial interest (ACCME Standard 5.1). All AAP CME activities must be compliant with the

ACCME’s CME Clinical Content Validation Policy:

All the recommendations involving clinical medicine in a CME activity must be

based on evidence that is accepted within the profession of medicine as adequate

justification for their indications and contraindications in the care of patients.

All scientific research referred to, reported or used in CME in support or justification

of a patient care recommendation must conform to the generally accepted standards

of experimental design, data collection and analysis.

Providers are not eligible for ACCME accreditation or reaccreditation if they present activities that

promote recommendations, treatment or manners of practicing medicine that are not within the

definition of CME, or known to have risks or dangers that outweigh the benefits or known to be

ineffective in the treatment of patients.

Presentations must give a balanced view of therapeutic options. Use of generic names will

contribute to this impartiality. If the CME educational material or content includes trade names,

where available trade names from several companies should be used and not just trade names from a

single company (ACCME Standard 5.2). Educational materials that are part of a CME activity, such

as slides, abstracts, and handouts, cannot contain any advertising, corporate logo, trade names

without generic names (but listing of trade names from several companies is permissible), or a

product-group message of an ACCME-defined commercial interest (ACCME Standard 4.3). Any

individual refusing to comply with the AAP Policy on Disclosure of Financial Relationships and

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3

Resolution of Conflicts of Interest for AAP CME Activities and/or not disclosing relevant financial

relationships on a timely basis (defined by the Committee on CME as the initial invitation and two

reminders) will not participate in, have control of, or responsibility for, the development,

management, presentation, or evaluation of AAP CME activities.

All AAP CME activities will be evaluated by learners and peer reviewers to determine if the

content was free of commercial bias. All those identified as having influence and/or control

of CME content perceived as either manifesting conflicts of interest or being biased may be

disqualified from consideration as resources (planning group member, authors, faculty, etc)

in subsequent CME activities for a time to be determined by the Committee on CME.

_________________________________________________________________________________

*faculty (live and online courses); authors of journal articles, self assessments, enduring materials

(eg. CD ROM, video, etc); CME planning groups/committees; CME editorial boards, AAP

Committee on CME, AAP Section/Council program chairs; abstract reviewers; peer reviewers;

abstract authors and presenters; staff serving as CME faculty or those directly impacting or

managing CME content or activities; spouse/partner

**ACCME considers relationships of the person involved in the CME activity to include financial

relationships, in any dollar amount, of a spouse or partner.

***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 defines “relevant financial relationships” as financial relationships in any amount

occurring within the past 12 months that create a conflict of interest. Conflicts of interest occur

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. Financial

relationships are those relationships in which the individual benefits by receiving a salary, royalty,

intellectual property rights, consulting fee, honoraria for promotional Speakers Bureau, ownership

interest (e.g., stocks, stock options or other ownership interest excluding diversified mutual funds) or

other financial benefits. Financial benefits are usually associated with roles such as employment,

management position, independent contractor (including contracted research), consulting, speaking

and teaching (including Speakers Bureaus), membership on advisory committees or review panels,

board membership, and other activities from which remuneration is received or expected.

(May 2015)

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Does it relate directly to theeducational assignment? No

Individual confirmed and staff completes

Resolution of COI Form and places in the

accreditation file

Not Sure

*The AAP has defined these as follows: faculty (live and online courses); authors of journal articles, self assessments, enduring materials (eg. CD

ROM, video, etc.); CME planning groups/committees; CME editorial boards, AAP Committee on CME, AAP Section/Council program chairs; abstract

reviewers; peer reviewers; abstract authors and presenters; staff serving as CME faculty and those directly impacting or managing CME content or

activities; spouse/partner

All individuals in a position to influence and/or control CME content*

disclose financial relationships to AAP staff

STEPS BEFORE CONFIRMATION OF FACULTY,

AUTHORS, STAFF AND OTHERS

Disclosure received?

(After 2 reminders)No Yes

Individual ineligible to participate in

proposed role. Planning groups,

editorial boards, etc.:

staff should work with chair (COCMEmember if conflict relates to chair).

Faculty, authors, etc.: staff should notify

appropriate planning group, editorial board

member, etc.

Financial Relationships

indicatedNo Confirm Role

Yes

Yes

Planning groups, editorial

boards, etc.: staff should seek

counsel from AAP physician staff or

with chair (COCME member if

conflict relates to chair). Faculty,

authors, etc.: staff should seek

counsel from AAP physician staff or

appropriate planning group, editorial

board member, etc.

Planning groups, editorial boards,

etc: staff works directly with the AAP

physician staff or chair (COCME

member if conflict relates to chair) to

review existing mechanisms in place

to safeguard against commercial

bias. Faculty, authors, etc: staff

works with appropriate planning

group, editorial board member, etc.

to review existing mechanisms

Individual confirmed and staff completes Resolution of COI

Form and places in the accreditation fileMechanisms in place are sufficient?

Planning groups, editorial boards,

etc.: staff and/or chair (COCME

member if conflicts relates to chair)

contacts individual to obtain

additional information to determine if

there is a conflict. Faculty,authors, etc.: staff and/or

appropriate planning group, editorial

board member,etc. contacts

individual to obtain additional

information to determine if there is a

conflict

No

Yes

COI resolved

Individual confirmed and staff

completes Resolution of COI

Form and places in theaccreditation file

COI exists that cannot be resolved

Individual dismissed from the educational

assignment. Staff completes Resolution of COI

Form and places in the accreditation file

Staff forwards AAP Policy on Disclosure and Resolution of COI and AAP Full Disclosure Statement

form to all individuals selected to plan CME activity content prior to confirmation of

their appointment and prior to the first planning meeting/call. Individuals seeking appointment to

editorial boards, etc. approved by ACBOE are required to complete and attach the AAP Full

Disclosure Statement Form to the Nomination Form.

Staff forwards the AAP Policy on Disclosure and Resolution of COI and

AAP Full Disclosure Statement form to proposed faculty, authors, etc.

selected to present/deliver CME activity content prior to their

confirmation

Disclosure of Financial Relationships and Resolution of Conflicts of Interest (COI) Procedures for AAP CME Activities

STEPS BEFORE YOUR INITIAL PLANNING MEETING

(PLANNING GROUPS, EDITORIAL BOARDS, STAFF AND OTHERS)

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STEP 4: Staff along with planning group/editorial board members, etc.

discuss mechanisms they will use to ensure no commercial bias in the

CME activity(see Resolution of Conflict of Interest Form). Staff

documents in minutes

STEP 3: Staff includes AAP policy and procedures on

Disclosure of Financial Relationships and Resolution of

COI in planning materials

5 REQUIRED STEPS TO PLANNING A

CME ACTIVITY

STEP 1: Staff includes the DIsclosure of Financial

Relationships and Resolution of COI item on every

planning agenda for discussion

STEP 2: Disclosure information provided by planning

group, editorial board members, etc. is presented

during meeting via the disclosure grid. Staff

documents disclosure information in minutes

STEP 5: Staff along with planning groups, editorial

boards,etc. determine perceived level of risk for

commercial bias and document in the CME activity

accreditation file and planning meeting notes

STEP 4: Staff reviews evaluation data to assess perception of

commercial bias to determine perceived level of risk and how it

compares to the level of risk projected in the CME activity

STEP 5: Staff documents the findings from assessment of risk in the CME

activity accreditation file and communicates this information to planning

groups, editorial boards, etc.

STEP 6: Concerns as a resullt of the evaluation data should be handled accordingly

including disqualification in future CME activities

STEP 2: Staff communicates to learners prior to the beginning of the CME activity all disclosure information

received from all individuals in a position to influence and/or control CME content including: name of individual,

name of the commercial interests, nature of the financial relationship the person has with each commercial

interest, discussion of off-label use. For an individual with no relevant financial relationship(s) the learners must

be informed that no relevant financial relationship(s) exist. (Note: It is not necessary to disclose how conflicts

were resolved.)

STEP 3: Staff conducts an evaluation of the CME

activity to determine the perception of commercial bias

All AAP CME activities must include a mechanism for

evaluating the perception of commercial bias (e.g. ,

inclusion of required questions on evaluation form)

6 REQUIRED STEPS TO

DELIVERING A CME ACTIVITY

STEP 1: Staff communicates

to learners AAP policies on

Disclosure and Resolution of

COI

Staff or faculty develop a disclosure slide for the individual faculty member as the first slide of the presentation.

Additionally, faculty who have disclosed that they serve on Speaker Bureaus are required to make the following

statement on an opening slide of their presentation, "It is my obligation to disclose to you (the audience) that I

am on the Speakers Bureau for (name of commercial interest). However, I acknowledge that today’s activity is

certified for CME credit and thus cannot be promotional. I will give a balanced presentation using the best available

evidence to support my conclusions and recommendations."

Disclosure of Financial Relationships and Resolution of Conflicts of Interest (COI) Procedures for AAP CME Activities

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Disclosure of Financial Relationships and Resolution of Conflicts of Interest Procedures

for AAP CME Activities

DESCRIPTION The procedures described in this document are in support of the American Academy of Pediatrics Policy on Disclosure of Financial Relationships and Resolution of Conflicts of Interest for AAP CME activities. As stated in AAP policy, “the ACCME requires accredited CME providers to identify and resolve all potential conflicts of interest with any individual in a position to influence and/or control the content of CME activities.” All identified financial relationships must be resolved in order for the individual to be confirmed in the proposed role for the educational assignment (see attached Glossary of Terms).

These procedures are available both in a step-by-step format as well as a flowchart and delineate the following:

PART 1: Disclosure of Financial Relationships and Resolution of Conflicts of Interest for planning groups, editorial boards, staff, and others responsible for planning CME activity content who are in a position to influence and control CME content

PART 2: CME Activity Planning Requirements PART 3: Disclosure of Financial Relationships and Resolution of Conflicts of

Interest for faculty, authors, staff and others selected to present and deliver CME activity content who are in a position to influence and control CME content

PART 4: CME Activity Delivery Requirements

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PART 1: Disclosure of Financial Relationships and Resolution of Conflicts of Interest for planning groups, editorial boards, staff, and others responsible for planning CME activity content who are in a position to influence and control CME content

STEP 1: Staff forward AAP Policy on Disclosure of Financial Relationships and Resolution of

Conflicts of Interest along with the AAP Full Disclosure Statement Form prior to confirmation of the appointment and prior to the first meeting/call of the planning group/editorial board, etc. to all individuals selected to plan the content of the CME activity. All individuals seeking appointment to editorial boards, etc. that are approved by the AAP Advisory Committee to the Board on Education (ACBOE) are required to complete and attach the AAP Full Disclosure Statement Form to the nomination form. Individuals submitting nomination forms that do not include the AAP Full Disclosure Statement Form will not be considered by the ACBOE.

STEP 2: Individuals identified to plan the content of the CME activity (eg, planning group members, editorial board members, etc) disclose financial relationships prior to the first meeting/call of the planning group, editorial board, etc. to AAP staff via the AAP Full Disclosure Statement Form. AAP staff, who directly impact or manage the CME content or activity, must disclose via the AAP Full Disclosure Statement Form. (NOTE: Confirmation of service for CME planning groups, editorial boards, etc is contingent upon the submission of disclosure information which may not include the use of a corporate logo, trade name or a product-group message of an ACCME-defined commercial interest, and any subsequent resolution of conflicts of interest.)

STEP 3: If the planning group member, editorial board member, etc. does not provide required disclosure information by the deadline date (and no more than two reminders), that individual will be considered ineligible to participate in the proposed role. Staff should work with the chair of the planning group/editorial board, etc. (or with a member of the COCME if the potential conflict relates to the planning group or editorial board chair, etc) to determine next steps.

STEP 4: If staff responsible for overseeing and managing the CME activity disclose a financial

relationship(s), AAP physician staff should first determine if the financial relationship cited relates to the educational assignment. If AAP physician staff are not able to ascertain this information, counsel should be sought from the chair of the planning group, editorial board, etc (or a member of the COCME). (All responsibilities outlined in Steps 5 and 6 below should be followed prior to the staff member(s)’s continued oversight and management of the CME activity.)

STEP 5: Staff review disclosure information received from the planning group member, editorial

board member, etc to determine: a) those individuals with no financial relationships (in this case, there is no conflict of interest to resolve and those individuals may be confirmed in their role as a member of the planning group or editorial board, etc) b) those individuals with financial relationships

i) Staff should first determine if the financial relationship cited relates to the educational assignment. If staff are not able to ascertain this information, they should seek counsel from AAP physician staff or from the chair of the planning group, editorial board, etc (or with a member of the COCME if the potential conflict relates to the planning group or editorial board chair, etc).

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ii) If the personal financial relationship cited does not relate to the educational assignment, the individual is confirmed and staff complete the Resolution of Conflict of Interest Form and places in CME activity file.

iii) If the personal financial relationship cited does relate to the educational assignment and suggests a possible conflict of interest, staff should work directly with AAP physician staff or with the planning group, editorial board chair, etc. (or with a member of the COCME if the potential conflict relates to the planning group or editorial board chair, etc.) to review the existing mechanisms in place to safeguard against commercial bias in the CME activity and based on that, determine if there is a definite conflict of interest.

If the mechanisms in place are sufficient and a conflict of interest is not identified, the prospective planning group or editorial board member, etc. is confirmed and staff complete the Resolution of Conflict of Interest Form (includes the list of mechanisms to eliminate commercial bias) to document the discussion of the resolution and inserts this form in the CME activity file.

If the mechanisms in place are not sufficient and there remains the possibility that there could still be a possible conflict of interest, staff and/or AAP physician staff or planning group, editorial board chair, etc. (or with a member of the COCME if the potential conflict relates to the planning group or editorial board chair) contacts the individual to obtain additional information to determine if there is a definite conflict of interest.

o If additional information is obtained to satisfy staff and planning group/editorial board chairs, etc. that there is no conflict of interest, the conflict of interest is resolved and the individual is confirmed as a member of the planning group or editorial board, etc. Staff complete the Resolution of Conflict of Interest Form and places in CME activity file.

o If additional information is obtained and staff and planning group/editorial board chairs, etc. still believe there is a conflict of interest that cannot be resolved, the prospective individual is dismissed as a member of the planning group or editorial board, etc. Staff complete the Resolution of Conflict of Interest Form to document the discussion of the resolution and inserts this form in the CME activity file.

STEP 6: Any financial relationship identified on the AAP Full Disclosure Statement Form that could

impact the content during the planning process will require that the planning group member, editorial board member, etc. recuses him/herself from the discussion.

STEP 7: All disclosure information must be shared with planning group members, editorial board

members, etc. prior to/at the beginning of the CME planning process and subsequently with learners in advance of the activity (e.g., via the AAP CME Disclosure Grid).

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PART 2: CME Activity Planning Requirements STEP 1: Staff include the Disclosure of Financial Relationships and Resolution of Conflict of Interest item on every CME activity planning agenda for discussion among staff and CME planning group members, editorial board members, etc. STEP 2: Disclosure information provided by CME planning group, editorial board members, staff, etc. is presented during planning meetings, calls, etc. via the disclosure grid. Staff document

the presented disclosure information in CME activity planning minutes. STEP 3: Staff include AAP policy and procedures on Disclosure of Financial Relationships and Resolution of Conflicts of Interest in planning materials. Staff emphasize that beyond the initial request for disclosure information from faculty, authors, etc. they will receive two reminders for this information and then staff discuss the possible disqualification of faculty, authors, etc. with the CME planning group, editorial board, etc. STEP 4: Staff along with planning group, editorial board members, etc. discuss mechanisms they will

use to ensure there is no commercial bias in the CME activity (See Resolution of Conflict of Interest Form for complete list of mechanisms and tools). Staff document these mechanisms in CME activity planning minutes along with any other related discussions.

STEP 5: Staff along with CME planning groups, editorial boards, etc. determine the perceived level of risk for commercial bias in the CME activity and documents that information in the CME activity file checklist and planning meeting call/notes.

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PART 3: Disclosure of Financial Relationships and Resolution of Conflicts of Interest for faculty, authors, staff and others selected to present and deliver CME activity content who are in a position to influence and control CME content

STEP 1: Staff forward to proposed faculty, authors, etc. selected to present or deliver CME activity content the AAP Policy on Disclosure of Financial Relationships and Resolution of Conflicts of Interest along with the AAP Full Disclosure Statement Form prior to their confirmation as faculty, authors, etc.

STEP 2: Individuals identified to present or deliver CME activity content (eg, faculty, authors, etc.) disclose financial relationships prior to their confirmation to AAP staff via the AAP Full Disclosure Statement Form. Any staff developing or presenting CME content must provide disclosure information and all conflicts of interest must be resolved. (NOTE: Confirmation of service for CME faculty, authors, etc. is contingent upon the submission of disclosure information which may not include the use of a corporate logo, trade name or a product-group message of an ACCME-defined commercial interest, and any subsequent resolution of conflicts of interest.)

STEP 3: If the faculty, author, etc. does not provide required disclosure information by the deadline date (and no more than two reminders), that individual will be considered ineligible to participate in the proposed role. Staff notify the appropriate planning group/editorial board member, etc. to discuss the disqualification and next steps in securing another individual for the educational assignment.

STEP 4: Staff review disclosure information received from the faculty, author, etc. to determine: a) those individuals with no financial relationships (in this case, there is no conflict of

interest to resolve and those individuals may be confirmed in their role as a faculty, author, etc.)

b) those individuals with financial relationships

i) Staff should first determine if the financial relationship cited relates to the educational assignment. If staff are not able to ascertain this information, they should seek counsel from AAP physician staff or from a member of the planning group, editorial board, etc.

ii) If the personal financial relationship cited does not relate to the educational assignment, the individual is confirmed and staff complete the Resolution of Conflict of Interest Form and places in CME activity file.

iii) If the personal financial relationship cited does relate to the educational assignment and suggests a possible conflict of interest, staff should work directly with AAP physician staff or with a planning group, editorial board member, etc. to review the existing mechanisms in place to safeguard against commercial bias in the CME activity and based on that, determine if there is a definite conflict of interest.

If the mechanisms in place are sufficient and a conflict of interest is not identified, the prospective faculty, author, etc. is confirmed and staff complete the Resolution of Conflict of Interest Form (includes the list of mechanisms to eliminate commercial bias) to document the discussion of the resolution and inserts this form in the CME activity file.

If the mechanisms in place are not sufficient and there remains the possibility that there could still be a possible conflict of interest, staff and/or AAP physician staff or planning group, editorial board member, etc. contact the individual to obtain

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additional information to determine if there is a definite conflict of interest. Options are reviewed with the individual and may include the following (See Resolution of Conflict of Interest Form for mechanisms and tools):

“We will conduct a peer review of your content prior to the activity.” (eg, review of handouts and/or slides)

“We will change the topic you were assigned.” “We ask you to limit the content to a report without practice

recommendations.” “We ask that you provide an evidence-based CME presentation.” “The content of your educational assignment will not relate to the

conflict of interest.” “We will focus the CME activity away from the conflict of

interest.” “You may decide to change your relationship with the

commercial interest.” “We will choose someone else to control that part of the content.”

o If additional information is obtained to satisfy staff and planning group/editorial board members, etc. that there is no conflict of interest, the conflict of interest is resolved and the individual is confirmed as a faculty, author, etc. Staff complete the Resolution of Conflict of Interest Form and places in CME activity file.

o If additional information is obtained and staff and planning group/editorial board members, etc. still believe there is a conflict of interest that cannot be resolved, the prospective individual is dismissed as a prospective faculty, author, etc. Staff complete the Resolution of Conflict of Interest Form to document the discussion of the resolution and inserts this form in the CME activity file.

STEP 5: If there are extenuating circumstances requiring last-minute addition of faculty for a CME

activity, disclosure must still be obtained and reviewed, and potential conflicts of interest, if any, must be identified and resolved. If time does not permit correction of written materials in which disclosure information is communicated, disclosure for the additional faculty shall be made verbally prior to the faculty’s presentation and so noted in the CME activity file.

STEP 6: All disclosure information must be shared with learners in advance of the activity (e.g., via the AAP CME Disclosure Grid).

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PART 4: CME Activity Delivery Requirements

STEP 1: Staff communicate to learners AAP Policy on Disclosure of Financial Relationships and Resolution of Conflicts of Interest to make them aware of the Academy’s commitment to provide them a commercially unbiased CME activity. (NOTE: this information can be provided in syllabi, program materials, enduring materials, etc.)

STEP 2: Staff communicate to learners all disclosure information received from all individuals in a

position to influence and/or control CME content (NOTE: It is not necessary to disclose how conflicts were resolved.) including:

name of the individual name of the commercial interest(s) nature of the financial relationship the individual has with each commercial

interest discussion of off-label use

(NOTE: For an individual with no relevant financial relationship(s) the learners must be informed that no relevant financial relationship(s) exist.) The above information must be disclosed to learners prior to the beginning of the CME activity. Live CME activities

Staff or faculty should develop a slide of disclosure information for the individual faculty member as the first slide of his/her presentation.

Additionally, faculty who have disclosed that they serve on Speaker Bureaus are required to make the following statement on one of the opening slides of their presentation, “It is my obligation to disclose to you (the audience) that I am on the Speakers Bureau for (name of commercial interest). However, I acknowledge that today’s activity is certified for CME credit and thus cannot be promotional. I will give a balanced presentation using the best available evidence to support my conclusions and recommendations.”

Additional questions may be directed to CME Accreditation Staff. Enduring material, journal and Internet CME

Disclosure information must appear to learners before the start of the activity (i.e. learners should not have to “click” on another screen to view disclosure information). Disclosure of discussion of off-label use need only be provided one time at the beginning of the CME journal issue, enduring material, etc. and before the learner enters into the CME content (ie, it is not necessary to provide a statement on the author’s intent to discuss off-label use at the beginning of each individual article or section within an enduring material or journal article).

Additional questions may be directed to CME Accreditation Staff. Other CME formats

Questions about other CME activity formats should be directed to CME Accreditation Staff to ensure the correct disclosure process is followed.

STEP 3: Staff conduct an evaluation of the CME activity to determine the perception of commercial

bias. All AAP CME activities must include a mechanism for evaluating the perception of commercial bias (eg, inclusion of a question on the evaluation form of the activity and/or faculty; inclusion of a question on the monitor evaluation form of the activity and/or faculty, etc.)

For those CME activities, sessions, faculty, etc considered to be of “higher risk,” staff along with CME planning groups, editorial boards, etc. ensure that there is a

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peer monitoring of that activity, session, faculty, etc. This evaluator will be asked to complete an evaluation form measuring any bias in the CME activity.

STEP 4: Staff review evaluation data to assess perception of commercial bias in the CME activity to

determine the perceived level of risk in that CME activity and how that compares to the level of risk initially projected for the CME activity.

STEP 5: Staff document these findings along with any additional documentation related to the

assessment of the evaluation data in the CME activity file and communicates this information to planning groups, editorial boards, etc.

STEP 6: Any concerns as a result of the evaluation data should be handled accordingly, including disqualification of individuals in future CME activities.

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GLOSSARY OF TERMS

Individuals in a position to influence and/or control CME content The AAP has defined these as follows: faculty (live and online courses); authors of journal articles, self-assessments, enduring materials (eg. CD ROM, video, etc.); CME planning groups/committees; CME editorial boards, AAP Committee on CME, AAP Section/Council program chairs; abstract reviewers; peer reviewers; abstract authors and presenters; staff serving as CME faculty or those directly impacting or managing CME content or activities; spouse/partner

Commercial Interest 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.

Financial relationships Financial relationships are those relationships in which the individual benefits by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria for promotional Speakers Bureau, ownership interest (e.g., stocks, stock options or other ownership interest excluding diversified mutual funds) or other financial benefits. Financial benefits are usually associated with roles such as employment, management position, independent contractor (including contracted research), consulting, speaking and teaching (including Speakers Bureaus), membership on advisory committees or review panels, board membership, and other activities from which remuneration is received or expected.

ACCME considers relationships of the person involved in the CME activity to include financial relationships, in any amount, of a spouse or partner.

* “Contracted research” includes research funding where the institution gets the grant and manages the funds and the person is the principal or named investigator on the grant. Relevant financial relationships ACCME focuses on financial relationships with commercial interests in the 12-month period preceding the time that the individual is being asked to assume a role controlling content of the CME activity. ACCME has not set a minimal dollar amount for relationships to be significant. Inherent in any amount is the incentive to maintain or increase the value of the relationship. The ACCME defines “relevant financial relationships” as financial relationships in any amount occurring within the past 12 months that create a conflict of interest. Conflict of Interest

Circumstances create a conflict of interest when an individual has an opportunity to affect CME content about products or services of a commercial interest with which he/she has a financial relationship.

What creates a conflict 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. The ACCME considers “content of CME about the products or services of that commercial interest” to include content about specific agents/devices, but not necessarily about the class of agents/devices, and not necessarily content about the whole disease class in which those agents/devices are used.

Revised May 2015

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Rev May 2015

AMERICAN ACADEMY OF PEDIATRICS (AAP) FULL DISCLOSURE STATEMENT FORM

As a provider accredited by the Accreditation Council for Continuing Medical Education (ACCME), the AAP is required to identify and resolve all potential conflicts of interest with any individual in a position to influence and/or control the content of CME activities. A conflict of interest will be considered to exist if the individual has received financial benefits in any amount from a

commercial interest (any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients) within the past 12 months and that individual is in a position to affect the content of CME regarding the products or

services of the commercial interest. All individuals in a position to influence and/or control the content of AAP directly and jointly provided CME activities are required to disclose to the AAP and subsequently to learners that the individual either has no relevant financial relationships or any financial relationships with the manufacturer(s) of any commercial product(s) and/or provider(s) of commercial

services discussed in CME activities. All disclosure information provided to the AAP will be reviewed to ensure that no conflicts of interest exist prior to the confirmation of the individual for the educational assignment. Additional information may be requested. It is the responsibility of the individual to notify the AAP of any changes in the disclosure information provided after the submission of this AAP Full Disclosure Statement Form. Name: ________________________________________________ Date: _______________________________

Please check all that apply: ___ Faculty ___Author ___Planning Group/Committee ____Editorial Board ___AAP Committee on CME

____AAP Section/Council Program Chair ___Abstract reviewer ___Abstract presenter ___ Staff

Phone Number: _________________________e-mail: _____________________Fax: ____________________

Name of CME activity: _________________________________Dates/location (if applies): ___________________________

Clinical/Non-Clinical Topics: _____________________________________________________________________________

Please complete Sections I and II; sign; date; and return this form to the appropriate AAP staff.

I. DISCLOSURE OF FINANCIAL RELATIONSHIPS WITHIN 12 MONTHS OF DATE OF THIS FORM

____ Neither I nor any member of my immediate family has a financial relationship or interest in any amount (currently or within the past 12 months) with any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used

on, patients. OR

____ I have or ____an immediate family member has a financial relationship or interest in any amount (currently or within the past 12 months) with an entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. The financial relationships are identified as follows (if needed, attach an additional list):

Relevant Financial Relationships Related to Your Content (check all that apply)

Name of Commercial Interest

(any entity producing, marketing, re-selling, or distributing health care goods or services

consumed by, or used on, patients.)

Research Grant (including funding to

an institution for contracted research)

Speakers’ Bureau

Stock/Bonds (excluding

Mutual Funds)

Consultant Other (Identify)

II. DISCLOSURE OF OFF-LABEL (UNAPPROVED)/INVESTIGATIONAL USES OF PRODUCTS

AAP CME faculty are required to disclose to the AAP and to learners when they plan to discuss or demonstrate pharmaceuticals and/or medical devices that are not approved by the FDA and/or medical or surgical procedures that involve an unapproved or “off-label” use of an approved device or pharmaceutical. ___ I do intend to discuss an unapproved/investigative use of a commercial product/device and will disclose such references to learners. ___ I do not intend to discuss an unapproved/investigative use of a commercial product/device.

I have read and will adhere to the AAP Policy on Disclosure of Financial Relationships and Resolution of Conflicts of Interest for AAP CME Activities. (If the policy is not attached to this form, call ________). I understand that failure or refusal to disclose within

the established timeframe will require the AAP to identify a replacement. I will uphold AAP Standards to insure balance, independence, objectivity and scientific rigor in my role in the planning or presentation of this CME activity.

Signature ___________________________________________________Date ____________________

RETURN BY _________ TO: ___________________ (fax) or _________ (email)

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RESOLUTION OF CONFLICT OF INTEREST FORM FOR AAP CME ACTIVITIES

The Resolution of Conflict of Interest Form is designed to assist AAP staff responsible for the development of CME activities in 1) determining if a conflict of interest exists; and 2) documenting the actions undertaken to resolve all potential conflicts of interest with any individual in a position to influence and/or control the content of CME activities. This form must be completed for all individuals returning an AAP Full Disclosure Statement Form that lists financial relationships with commercial interests. Staff should reference the AAP Policy and Procedures on Disclosure of Financial Relationships and Resolution of Conflicts of Interest for AAP CME Activities. This form should be inserted in the appropriate CME activity file that includes all the necessary documentation to ensure full compliance with ACCME Essentials, Elements, and Standards. Questions should be forwarded to Virginia Roldan, Accreditation Coordinator [email protected] or 630-626-6653. Staff, CME planning groups, and CME editorial boards have a variety of mechanisms available to resolve a potential conflict of interest and are asked to review the following list to determine if any of these mechanisms are adequate in resolving potential conflicts of interest. Once that determination has been made, staff should document the mechanism(s) that were used to resolve the potential conflict of interest. If it is determined that there remains a conflict of interest that cannot be resolved, staff should document that as well and insert this form in the CME activity file (for DOE activities) or submit as part of the application or post submission process (for joint/direct provided activities). Note: Documentation that shows the selected resolution below actually occurred is mandatory. Examples of this documentation include emails, notes, minutes, screenshots, etc. DOCME Accreditation staff will follow up to obtain this information if it is not submitted as part of the CME activity file (for DOE activities) or application/post submission (for joint/direct provided activities). PLEASE COMPLETE THE FOLLOWING: NAME OF INDIVIDUAL WITH THE EDUCATIONAL ASSIGNMENT: __________________________________________

NATURE OF THE EDUCATIONAL ASSIGNMENT: ________________________________________________________ (eg, CME Planning Group member, author, faculty, etc)

NAME OF THE CME ACTIVITY (DATES/LOCATION IF APPLICABLE) ________________________________________

NAME OF THE PERSON RESOLVING THE CONFLICT: ___________________________________________________ (Must also complete a disclosure form)

NAME OF STAFF MEMBER SUBMITTING THIS FORM ______________________________ DATE ____________ ___ Upon review of the AAP Full Disclosure Statement Form, it was determined that the financial relationship did not relate to the educational assignment. IF SO, YOUR FORM IS NOW COMPLETE. INSERT IN CME ACTIVITY FILE. IF NOT, PLEASE PROCEED

OR

___ Upon review of the AAP Full Disclosure Statement Form, it was determined that a potential conflict may exist and the following mechanism(s) were used to resolve that potential conflict of interest:

1. ___ “We used a peer review process* for enduring material, Internet CME, journal CME, abstracts, etc.” (process in which materials are peer reviewed or judged against predetermined criteria to ensure the data support the conclusions before they are accepted for presentation or publication)

2. ___ “We conducted a peer review* of the individual’s content prior to the live CME activity.” (eg, review of handouts and/or slides). Faculty will be required to revise content based on recommendations from the peer review.

3. ___ “We altered the control over the content by”: ___choosing someone else to control that part of the content ___changing the focus of the CME activity

___changing the content/topic of the individual’s educational assignment so that it does not relate to the products or services of the commercial interest

___limiting the individual’s content to a report without practice recommendations (if individual was funded by a commercial company to perform research, the individual’s presentation may be limited to research data and results)

___limiting the role of the individual to reporting practice recommendations based on formal structured reviews of the literature with the inclusion and exclusion criteria stated (evidence-based) (eg, the Cochrane Collaboration)

___other (please describe) _______________________________________________________________

4. ___ “The individual was able to document the ‘best available evidence’ to support his/her recommendations.” (eg, individual provided adequate references) (Suggestion: The individual may state to the learners, “the best available evidence in the literature is at the level of < > and supports the following conclusions < >. Integrating what this literature says with what the new study has revealed, my recommendations on what we should do now are < >”.)

5. ___ “The individual decided to change his/her relationship with the commercial interest eliminating the financial relationship and thus, any potential for conflict of interest.”

6. ___ “We chose not to use the individual and identified a replacement.”

7. ___ Other (please describe) ____________________________________________________________________ *Peer review must ensure that 1) all practice recommendations involving clinical medicine are based on evidence that is accepted within the profession of medicine as adequate justification for indications and contraindications in the care of patients; and 2) all scientific research referred to, reported or used in the CME activity in support or justification of patient care recommendations conforms to the generally accepted standards of experimental design, data collection and analysis.

INSERT THIS FORM AND DOCUMENTATION OF ALL CORRESPONDENCE THROUGH WHICH CONFLICT OF INTERESTS WERE RESOLVED IN THE CME ACTIVITY FILE (FOR DOE ACTIVITIES) OR SUBMIT AS PART OF THE APPLICATION OR POST SUBMISSION FOR JOINT/DIRECT PROVIDED ACTIVITIES (Last Updated Dec 2017)

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AAP Committee on CME (COCME) Guidelines for Addressing Intellectual Property in AAP CME Activities All AAP CME activities must fully comply with the Accreditation Council for CME (ACCME) Standards for Commercial Support, and all planning group members, editorial board members, faculty, and authors (herein referred to as “faculty”) must comply with the AAP Policy on Disclosure of Financial Relationships and Resolution of Conflicts of Interest. The COCME recognizes that AAP CME faculty are experts in their specialty or subspecialty, and many have authored or otherwise participated in the development of AAP and non-AAP intellectual property. These intellectual properties include, but are not limited to, publications, books, papers, manuals, digital media, toolkits, and self-assessment materials. The COCME has set forth guidelines for faculty to follow when participating in an AAP CME activity, when they have collaborated on or developed intellectual property. I. For intellectual property in which the faculty member receives a financial benefit from sales of the product Participation in AAP CME activities must meet all standards for disclosing financial support. When authors stand to gain financially, they must disclose their financial support to the AAP and to learners. Faculty who have authored intellectual property and receive a financial benefit from sales of the product must not exploit their participation as invited faculty in an AAP CME activity as an opportunity for self- or product-promotion. Faculty may list their intellectual property, when appropriate, within a listing of references or bibliography in their educational materials (syllabus, handouts, CD-ROM, etc.) associated with the AAP CME activity in which they are participating. It is acceptable to use content from the intellectual property with the appropriate credit given to the source and in compliance with the AAP Policy on Allegations of Plagiarism. However, in the CME activity, the faculty member must not: a) indicate where or how to purchase or order the intellectual property, b) show, display, or market the intellectual property, nor c) direct learners to a location, such as an exhibit table, exhibit hall site, or web site, to

view, purchase, or order the intellectual property. II. For intellectual property in which the faculty member does not receive a financial benefit from sales of the product Faculty who have authored intellectual property, but do not receive a financial benefit from sales of the product, must also meet all standards for disclosing financial support. Faculty must not use their participation in an AAP CME activity as an opportunity for self- or product-promotion. Faculty may list this intellectual property, when appropriate, within a listing of references or bibliography in their educational materials (syllabus, handouts, CD-ROM, etc.) associated with the AAP CME activity in which they are participating. It is acceptable to use content from the intellectual property with the appropriate credit given to the source and in compliance with the AAP Policy on Allegations of Plagiarism. However, in the CME activity, the faculty member must not: a) indicate where or how to purchase or order the intellectual property, b) show, display, or market the intellectual property, nor c) direct learners to a location, such as an exhibit table, exhibit hall site, or web site, to

view, purchase, or order the intellectual property.

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III. For intellectual property developed in association with the AAP Intellectual properties developed in association with the AAP constitute a special case, for which authors may or may not stand to gain financially. In those cases when authors stand to gain financially from sales of the AAP product, they must disclose their financial support to the AAP (in relation to the CME activity in which they are participating) and to learners. AAP intellectual property is aimed at educating AAP members to enhance their practice and learning and improve children's health. Faculty may refer both verbally and in visual aids to AAP intellectual property (toolkits, self-assessment materials, patient education materials, Red Book, etc.) with the appropriate credit given to the source and in compliance with the AAP Policy on Allegations of Plagiarism. The AAP intellectual property may be included, when appropriate, within a listing of references or bibliography in the educational materials (syllabus, handouts, CD-ROM, etc.) within the context of other similar informational resources available. However, in the CME activity, the faculty member must not: a) indicate where or how to purchase or order the intellectual property, b) market the intellectual property, nor c) direct learners to a location, such as an exhibit table, exhibit hall, or web site, to

view, purchase, or order the intellectual property. IV. Implementation and Compliance The COCME will rely on CME planning groups, editorial boards, and AAP staff to communicate these guidelines to their faculty and authors, monitor the implementation in their respective AAP CME activities, and take any action needed to ensure compliance. If any action is taken, documentation of such action should be included in the CME activity’s accreditation file maintained at the AAP office.

Any questions about these COCME guidelines may be directed to AAP Division of CME staff. 7/08; Revised: 5/10, 1/17

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AAP Policy on Allegations of Plagiarism September, 2016

Introduction

The mission of the American Academy of Pediatrics (AAP) is to attain optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults. To accomplish this mission, the AAP shall support the professional needs of its members. The maintenance of public trust and the AAP’s integrity, ethical standards, credibility, and identify are of paramount importance in accomplishing that mission and will be protected with the utmost vigilance. The policy outlined in this document serves as a general guide for the AAP at the national level to address allegations of plagiarism in submitted works for hire, journal articles or educational material. The AAP expects all scholarly material to be free from either intentional or non-intentional acts of plagiarism and recognizes the need to have a policy that educates authors, editors, and staff about the definition of plagiarism, the AAP’s right to check submissions with anti-plagiarism software, the verification and subsequent review process of materials of questionable origin, and consequences.

Definition

The AAP’s definition of plagiarism adopts the definition used by the American Medical Association’s Manual of Style, ” Verbatim lifting of passages without enclosing the borrowed material in quotation marks and crediting the original author” - Reference: AMA Manual of Style, 10th ed. All scholarly materials submitted to the AAP as works for hire, journal articles or original materials must be original content, created in the authors’ own words and not previously published. While the AAP encourages authors to develop educational materials that incorporates AAP publications, all such materials must make attribution to the original source.

Education All author guidelines, reviewer guidelines, faculty guidelines and new writers’ orientations will include the above mentioned definition and will provide examples on how to cite both verbatim and paraphrased content with appropriate attribution. Authors will be advised that the AAP has the right to check all submissions with anti-plagiarism software and take appropriate action as outlined in this policy. All medical editors, reviewers and editorial or advisory boards will receive guidelines to increase awareness of potential plagiarism with suggestions for identifying suspect material.

Discovery and Verification of Findings

All cases of suspected plagiarism should be immediately reported and investigated by the AAP product/project manager. The AAP product/project manager, in consultation with the medical editors and other AAP leadership will review each alleged case and determine if plagiarism has occurred. AAP, in as much as possible, will follow the guidelines set forth by the Committee on Publication Ethics (COPE) in the following flowcharts:

• Suspected plagiarism in a submitted manuscript • Suspected plagiarism in a published manuscript

If plagiarism is suspected, the authors will be asked to respond in writing to the allegations.

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Consequences Upon a determination of guilt, and depending on the authors’ responses and in consultation with the AAP product/project manager, and the medical editors, the following next steps are available to AAP leadership:

1. Admonition of guilt by the authors and correction of submitted work 2. Removal of content from online web sites; notice posted 3. Removal of the author from his/her current writing position or editorial board roles, if

applicable 4. Disallowed participation from publishing in any AAP scholarly publication in the future 5. Notification to the author’s institution or superior

All authors, including co-authors, will be notified in writing of any subsequent actions taken by the AAP. If the author or co-authors do not respond to correspondence, AAP reserves the right to move forward with any of the above actions.

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Compendium of Educational Resources for CME/CPD Planners To assist planners of AAP continuing medical education (CME)/continuing professional development

(CPD) activities in meeting the educational needs of pediatricians and pediatric healthcare professionals, a

list of resources has been compiled as outlined in this document. Resources will be edited or added, as

appropriate.

Adult Learning Theory, Needs Assessment, Learning Objectives

Materials posted on PediaLink at: http://pedialink.aap.org/visitor/cme/about_aap_cme# (under “Educational Resources” section), such as the following topics:

o Gaps and Needs Assessment Information, which includes Chapter Connections articles on the following topics: “CME and the Cycle of Learning” - October 2010

“Twelve Universal Principles of Adults as Learners” – January 2010

“Understanding Systematic Design of Instruction” – October 2009

“Understanding Learner Gaps and Needs” – July 2009

“Continuing Medical Education: Is ‘Change’ Necessary?” – April 2009

“Reflection in the Teaching of Medicine” – July 2011

o Desirable Physician Attributes Information

“Designing Meaningful CME” webinars, developed by the Committee on CME, September 2010

- Webinars and transcripts available at: http://pedialink.aap.org/visitor/cme/about_aap_cme#

Articles published in The Journal of Continuing Education in the Health Professions (JCEHP):

http://onlinelibrary.wiley.com/journal/10.1002/%28ISSN%291554-558X

Additional Articles:

Adult Learning Theory:

(New) Kaufman, D. M. (2003). Applying educational theory in practice. BMJ, 326(7382), 213-

216. doi: http://dx.doi.org/10.1136/bmj.326.7382.213

(New) Newman, P., & Peile, E. (2002). Valuing learners’ experience and supporting further

growth: educational models to help experienced adult learners in medicine. BMJ, 325(7357), 200-

202. doi: http://dx.doi.org/10.1136/bmj.325.7357.200

Angelo, T. A. (1993). A" TEACHER'S DOZEN”. American Association of Higher Education

Bulletin, April, 3-13.

– A very practical article outlining 14 general research-based principles to enhancing

adult learning. Although from 1993, the principles discussed are timeless and useful for

today’s pediatrician.

Dennick, R. (2012). Twelve tips for incorporating educational theory into teaching practices.

Medical teacher, 34(8), 618-624.

– 12 practical educational recommendations based on the learning theories found in

the literature.

Schumacher, D. J., Englander, R., & Carraccio, C. (2013). Developing the Master Learner:

Applying Learning Theory to the Learner, the Teacher, and the Learning Environment.

Academic Medicine, 88, 1635-1645. doi: 10.1097/ACM.0b013e3182a6e8f8

(New) Price, D. W., Wagner, D. P., Krane, N. K., Rougas, S. C., Lowitt, N. R., Offodile, R. S., . . .

Barnes, B. E. (2015). What are the implications of implementation science for medical education?

Medical Education Online, 20, 27003. http://dx.doi.org/10.3402/meo.v20.27003

Needs Assessment:

Grant, J. (2002). Learning needs assessment: assessing the need. BMJ: British Medical Journal,

324(7330), 156. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC64520/pdf/156.pdf – This article provides a wonderful overview of the different ways one can assess “needs”.

Moore, D. E. (1998). Needs assessment in the new health care environment: combining

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discrepancy analysis and outcomes to create more effective CME. Journal of Continuing

Education in the Health Professions, 18(3), 133-141.

http://acmd615.pbworks.com/w/file/fetch/47844054/133_na_cme.pdf

Learning Objectives:

Waller, K. V., & Directors, N. B. O. (2001). Writing instructional objectives.

http://www.naacls.org/docs/announcement/writing-objectives.pdf

– This article includes the steps involved in writing objectives along with a long list of verbs to be used in writing these objectives.

Teaching Competencies:

Srinivasan, M., Li, S. T., Meyers, F. J., Pratt, D. D., Collins, J. B., Braddock, C., … Hilty, D. M.

(2011). “Teaching as a Competency”: Competencies for Medical Educators. Academic Medicine, 86, 1211-1220. doi: 10.1097/ACM.0b013e31822c5b9a.

CME Formats and Activities Developed by the AAP

Educational Activity Format Information – Document is posted on PediaLink at -

http://pedialink.aap.org/visitor/cme/about_aap_cme# (under “Educational Resources” section)

CME information posted on AAP web site: http://www.aap.org/en-us/continuing-medical-

education/Pages/Continuing-Medical-Education.aspx

Maintenance of Certification information posted on PediaLink at:

http://pedialink.aap.org/visitor/moc/home

PediaLink CME Finder: http://pedialink.aap.org/visitor/cme/cme_finder

Accreditation/Credit Requirements

Accreditation Council for CME: http://www.accme.org/cme-providers http://www.accme.org/education-and-support - Multimedia resources, including video addressing

frequently asked questions about accreditation requirements and the planning and implementation of CME activities, in addition to interviews with health care leaders who share their approaches to planning effective education, are posted.

American Medical Association Physician’s Recognition Award: http://www.ama- assn.org/ama/pub/education-careers/continuing-medical-education/physicians-recognition-award-

credit-system.page?

National Faculty Education Initiative - The National Faculty Education Initiative (NFEI) provides online training on the differences between Certified CME and Promotional Activities.

http://www.nfeinitiative.org/

CME Effectiveness and Evaluation

Moore, D. E., Green, J. S., & Gallis, H. A. (2009). Achieving desired results and improved outcomes: integrating planning and assessment throughout learning activities. Journal of Continuing Education in the Health Professions, 29(1), 1-15. doi:10.1002/chp.20001.

Reed, V. A., Schifferdecker, K. E., & Turco, M. G. (2012). Motivating learning and assessing outcomes in continuing medical education using a personal learning plan. Journal of Continuing

Education in the Health Professions, 32(4), 287-294. doi:10.1002/chp.21158

(New) Cervero, R. M., & Gaines, J. K. (2014). Effectiveness of continuing medical education: updated

synthesis of systematic reviews. Retrieved from Accreditation Council for Continuing Education

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website: http://www.accme.org/sites/default/files/2014_Effectiveness_of_Continuing_Medical_Education_Cervero_and_Gaines_0.pdf

(New) CME: ACCP Evidence-based Educational Guidelines, 135(3_suppl). – The March 2009 American College of Chest Physicians Journal contains many articles relevant to the effectiveness of CME. http://journal.publications.chestnet.org/issue.aspx?journalid=99&issueid=22148#tocHeading_26024

AAP CME Outcomes Project – Document is posted on PediaLink at:

http://pedialink.aap.org/visitor/cme/about_aap_cme# (under “Educational Resources” section)

Quality Improvement and CME

(New) Kitto, S., Goldman, J., Etchells, E., Silver, I., Peller, J., Sargeant, J., . . . Bell, M. (2015).

Quality improvement, patient safety, and continuing education: a qualitative study of the current

boundaries and opportunities for collaboration between these domains. Academic Medicine, 90(2),

240-245.

Creating CME Activities to Promote Behavioral Change

Parker, K., & Parikh, S. V. (2001). Applying Prochaska’s model of change to needs assessment,

programme planning and outcome measurement. Journal of evaluation in clinical practice, 7(4), 365-

371. - http://groups.medbiq.org:8080/medbiq/download/attachments/229542/prochaska_cme.pdf

Proposing Content for AAP CME Activities

Documents posted on PediaLink under “About AAP CME” on how to propose content for AAP CME

activities and for AAP e-learning courses. http://pedialink.aap.org/visitor/cme/about_aap_cme#

Teaching Tips for Presenters

Roberts, D. H., Newman, L. R., & Schwartzstein, R. M. (2012). Twelve tips for facilitating

Millennials' learning. Medical teacher, 34(4), 274-278.

http://www.xyoaa.org/sites/all/modules/ckeditor/ckfinder/ckfinder/userfiles/files/education_materials/

Millennials'%20Learning%20Tips.pdf

Snell, Y. S. L. S. (1999). Interactive lecturing: strategies for increasing participation in large group presentations. Medical Teacher, 21(1), 37-42. http://med.ubc.ca/files/2012/03/Interactive-Lecturing-

Strategies.pdf

PediaLink Teaching & Learning Resource Center (requires login to PediaLink) http://pedialink.aap.org/ped/resources/tlrc/home - After logging-in to PediaLink, the Teaching &

Learning Center is located toward the bottom of the PediaLink home page.

Access free educational courses and resources on the following topics:

o Teaching Tips Interactive Teaching Tips Curriculum Design Tips

Presentation Tips Group Technique Tips

PowerPoint Formatting Tips

o Learning Tools o ACGME/ABMS Core Competencies o Procedures

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CME/CPD Organizations

Materials/links posted at Alliance for Continuing Education in the Health Professions web site –

http://www.acehp.org/p/cm/ld/fid=10

- A list of resources is provided via links on this page

Materials/links posted at the Society for Academic CME web site –

http://www.sacme.org/CME_Resources

- Among the resources of relevance are “Books,” “Conversations in CME,” “Gap Analysis,”

“Glossaries,” and “Toolkits and Guides”

http://www.sacme.org/Research_Resources

- Among the resources of relevance are those on the website for the Centre for Learning in Practice

(CLIP)

AAP Resources

AAP Quarterly CME Update Newsletters: Guidance on the development and delivery of CME

activities and information on the AAP CME/CPD program and individual activities are included

in these newsletters, which are posted on the PediaLink “About AAP CME” page, under the “AAP

Continuing Medical Education” section. http://pedialink.aap.org/visitor/cme/about_aap_cme

AAP Policy, Journals, and AAP News: http://www.aappublications.org/

AAP Department of Federal Affairs, Health Care Reform (for information on the Academy's federal

policy priorities): www.aap.org/federaladvocacy

AAP Department of State Affairs: www.aap.org/stgovaffairs (must be logged into My AAP) /

www.aap.org/stateadvocacy

Additional Resources

“The ABCs of Accredited CME” http://www.abcsofcme.org/

- The American Academy of Dermatology and The France Foundation, both ACCME-accredited providers, developed this online educational activity – The ABCs of Accredited CME – to clarify that the intent of the "rules" is that accredited CME be based on the principles of adult learning and be

independent of industry influence. This online educational activity is presented in short modules and participants can select which module(s) they wish to complete. Participants are required to register

at the web site, but there are no fees or restrictions to participate in the educational activity.

Materials/links posted at the American Academy of Family Physicians (AAFP) web site: http://www.aafp.org/cme/faculty/resources.html - AAFP CME Faculty Resource Center, including tools to help guide the content development process (e.g., composition of learning objectives, utilization of evidence-based resources, etc.).

Association of American Medical Colleges (AAMC) Continuing Education and Improvement

(CEI) Section: Information and resources posted at https://www.aamc.org/initiatives/cei/ “Redesigning Continuing Education in the Health Professions” (IOM, 2010;1-14).

http://iom.edu/reports/2009/redesigning-continuing-education-in-the-health-professions.aspx

Information on Health Care Disparities: http://www2.aap.org/commpeds/resources/health_equity.html

National Guideline Clearinghouse: www.guideline.gov

AAP Division of CME – March 2016

http://pedialink.aap.org/visitor/cme/about_aap_cme

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AAP Blueprint for Blended Learning Introduction

What is Blended Learning? Blended learning is a learning event where more than one delivery mode is used with the objective of optimizing the learning outcome. The focus is enhanced learning experiences for the particular group of participants, not the mix of delivery modes. Creating blended learning is an evolutionary process. The first stage may be to simply supplement live, faculty-led programs with online activities (modules, interactive handouts, self-assessments) and/or print activities to extend the learning process of participants. The second stage may include redesign of learning programs resulting in a broader range of learning opportunities for participants. Benefits

At the very core of this educational approach lies the belief that learning is not an event, but a continuous process. The reflective practitioner does not learn in a peaks and valleys manner, but continuously learns, reflects, applies, and adapts. Educational approaches providing opportunities for continuous learning will become standard in the near future. Our ultimate goal is to establish best blended learning practices for the AAP by increasing the quality, consistency, and effectiveness of continuing medical education.

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There are numerous benefits associated with the use of a blended learning approach. Perhaps the greatest asset of blended learning is that it provides the combined benefits of the multiple delivery modes (faculty-led, self-study, print, mediated). These benefits seem particularly important to the AAP’s educational programming. Improved learning effectiveness The link between needs assessment and educational intervention becomes very apparent in the blended learning approach. Audience analysis is critical to effectively determining which delivery options will be used to achieve the objectives. Learning outcomes can be improved by providing a better match between the learning program offered and how a learner wants to learn that content. Message consistency Blended learning with multiple delivery modes offers the opportunity to standardize a particular practice or reinforce key educational messages by delivering via media rather than relying on multiple faculty to present the material. Extended reach The limitations of any single delivery mode include a failure to reach key participants or transfer critical knowledge. Blended learning approaches can minimize the factors of location, time, and seating capacity. Improved instructional effectiveness The time spent with faculty in face-to-face settings can be maximized by providing prerequisite materials through alternative media. This creates opportunities to use the time in a live setting more productively. Extended learning Blended learning can help prepare participants to come to live, faculty-led events primed and ready to focus on the content. Blended learning also affords the opportunity to encourage and challenge participants to apply the information in their own practice. Follow-up activities can take the shape of refresher information to collaborative projects and facilitator-led discussions. Strategies A successful blended learning strategy requires acceptance at all levels. Planning groups, faculty, and participants all must commit to and place a premium on careful preparation and self-evaluation. Empowering learners to become active participants in the learning process supports the notion of continuous learning. This may also create the impetus to form collaborative learning communities. Blended learning is often associated with combining traditional live educational sessions with online activities. At the simplest level this might be a combination of online activities designed to help participants prepare for or reflect on live, faculty-led sessions. A more complex approach might offer the combination of self-paced online activities with extended, collaborative practice improvement projects.

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Approach

Blended learning can be introduced via a few key pilot ventures. Smaller, more focused groups with the purpose of learning new skills or sharing new practice information offer the opportunity to work closely with both faculty and participants. AAP staff will provide faculty with support and tutoring. We anticipate a number of outcomes from these pilot ventures. One anticipated outcome is the formation of collaborative learning groups. While not every pilot will result in the formation of a collaborative learning group, we want to encourage this possibility. Extending the longitudinal learning through association with a collaborative group creates an added benefit for these participants. Planning groups or faculty potentially will fill the role of facilitators for collaborative learning groups. Identifying Content to Present Online and Content to Present Face-to-Face A successful blended learning event requires careful integration of the online and live, faculty-led educational components; the integration maintains the complementary strengths of each component. Planning a blended learning event begins with assessing the best way to spend the time allocated for the live portion and identifying what participants need to know or be able to do to fully participate in the live portion. The rest of the educational component planning hinges on what learning experience (delivery mode) is best for the specific types of content. Blended Learning Plan An approach to blended learning is to use “advanced organizers” designed to help participants prepare for live, faculty-led events. An orienting, measurement activity leads into the live, faculty-led event and is followed by an outcomes measure. Any pairing of the following pre-activity or post-activity with learning activities that seems logical will work. Measures are important to identify the impact on or change in practice as well as the effectiveness of learning. If pre-activity tasks and post-activity tasks are collaborative, participants benefit from the experience and knowledge of others, including peers. It is also possible to see the benefit across different practices.

Potential Pre-activity Tasks Read faculty-selected resources Reflect on specific questions that relate to topics in activity Relate the proposed content to your practice Relate the activity to a need Complete a topic-related self-assessment to establish your level and your need Perform a task related to the content of the activity: submit the results of the task Identify 3 personal questions that you hope to have answered in the program What are your objectives in attending: how will this experience

change/support/effect your practice Questionnaire: Is this a new skill you plan on instituting? What makes you want to do

so? Pre-test on the content: Do you need it at the level planned, at another level? What is

your level of competence or proficiency?

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Potential Learning Activities Live Activity: PPC, NCE, Future of Pediatrics, PREP The Course, Chapter

activity, etc. Text-based: Pediatrics in Review, Grand Rounds, Pediatrics, PREP SA, etc. Web-based: PediaLink modules, eQIPP Audio-based: PREP Audio, podcasts Practice Improvement Quality Improvement Learning in a collaborative group with facilitation

Potential Post-Activity Tasks Task 1 Task 2

Complete a commitment to change contract: Respond as an individual at intervals after the activity reporting utilization, barriers

Continue to modify the application, report the success and practice change, identify strategies to minimize barriers. Measure practice improvement

Form a collaborative group of persons with similar interests and practices.

Meet or correspond to create practice change projects and indicate effects in multiple practices. Must have a measurable outcome. Have a facilitator or be self-facilitated

Meet or correspond over 4-8 months after the event. Implement the same change in multiple practices. Measure an outcome

Develop a QI network to implement a change. Measure the change. Identify one skill that you will implement. Complete an analysis of the effectiveness using specific measures.

Ongoing event

If you identified questions you wished to have answered, continue to identify information sources on the topic and identify whether your questions were answered and how you used the information in a clinical context.

Questionnaire: What did you learn in the session? What did you apply? Did the session change your thinking,

confirm what you know, or you will not use it?

What will you do differently in practice?

If useful, how did you use the information? If it confirmed what you knew, did you benefit from that information?

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If you had a pre-test to identify your level, take a post-test, and account for changes.

If you completed a needs assessment, did the session fulfill your needs? In what way? Can you demonstrate how?

Roles and Responsibilities

Divisions of E-Learning, CME, and Scholarly Journals and Professional Periodicals Help planning groups and faculty operationalize blended learning plans. Provide guidance on which delivery modes will help optimize desired outcomes. Planning groups: Introduce a continuum of blended learning opportunities into the overall mix for an

educational event. Promote blended learning as a path to longitudinal learning. Identify desired outcomes appropriate for the content and participants involved in

educational events. Act as facilitator for a collaborative learning group.

Faculty: Support and collaborate to integrate blended learning into their educational

content. Act as facilitator for a collaborative learning group.

Event Characteristics

We need to understand the nature of each of the AAP’s live events. Using event evaluation data, we can examine participants’ requests for additional information, new topics, or new approaches. With the characteristics of the event and participants in hand, we can more accurately match the appropriate delivery mode for the blended learning component of the event.

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