Complying with Complying with ACCME Essential ACCME Essential Areas and PoliciesAreas and Policies

The Responsibilities of ACCME Accredited Sponsors of Continuing

Medical EducationWASHINGTON HOSPITAL CENTERWASHINGTON HOSPITAL CENTER

March 18, 2003March 18, 2003

April 9, 2023 2

1. Define ACCME’s 3 Essential Areas.2. Provide explanations of each of the ACCME

Essential Areas.3. Discuss AMA/PRA and how it relates to CME.4. Discuss the ethical considerations in providing

CME.5. Explain the role of the supporter in CME

related activities, the changing Standards for Commercial Support, and the PhRMA Code of Ethics / OIG Regulations

Today’s Objectives

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Washington Hospital Center’s CME Regulatory Authority

ACCME accredits WHC as a provider of CME Accreditation currently is

4 years Failure to comply can result in loss of accreditation or probation Physicians can report irregularities to the ACCME

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ACCME Structure

Parent Organization Organizations AMA (American Medical Association) AHA (American Hospital Association) ABMS (American Board of Medical Specialties) AAMC (Association of American Medical Colleges) CMSS (Council of Medical Specialty Societies) FSMB (Federation of State Medical Boards) AHME (Association for Hospital Medical Education)

ACCME works with the AMA in issuing guidelines and

considerations for CME…

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THE AMA/PRA

AMA

establishes rules on

the awarding of the

credit bearing the

AMA/PRA name. They “own” the credit we give to physicians.

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Determination of CME Credit Awarded

The Director of CME is ultimately responsible for determining the appropriate maximum number of CME credits for a given activity

Maximal determination is based on the number of hours/minutes involved with carrying out the CME activity

Live (actual time minus breaks) Enduring materials/journal-based

• Based on best estimates for average physician Each physician must claim only those hours spent on

the CME activity up to the maximum

April 9, 2023 8

Review Operating Authorities in Policy and Procedure Manual

ACCME Essential Areas

Essential Area 1Essential Area 11. CME Mission

2. Congruence with Parent Mission

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Essential Area 1 – Purpose and Mission

CME Mission Statement WHC has revised this for 2003 (see Handouts)

CME Mission Statement content Purpose Statement Goals/Purpose Areas of content Target audience Types of activities (live, journal-based, enduring, etc) Expected results of CME activities

Congruent and supported by the mission statement of MedStar

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WHC’s CME Mission (Purpose)Washington Hospital Center (WHC) has a longstanding tradition of excellence in patient care, medical education and research. This tradition continues as evidenced by the Hospital Center's mission statement:

"We will provide a unique academic health center model for the education of superior quality health care professionals and the advancement of clinical research.“

We recognize the importance of medical education as an integral component of the provision of quality health care and that the professional responsibility of physicians requires continuous learning throughout their careers. We strive to advance the following tenets of our continuing medical education program:

To provide practicing physicians with educational opportunities that will contribute to their professional learning, maintain clinical competency, and promote the appropriate implementation of medical advances

To stimulate the desire of WHC-affiliated physicians to apply CME skills learned to the care of their patients

To foster an environment of lifelong learning for WHC physicians so that professional standards are maintained.

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MedStar Mission The mission of MedStar Health is to serve the needs of our patients in the Baltimore/ Washington region by providing superior, comprehensive health care services in a unique patient-first environment. We achieve our mission by being a community-owned, academically oriented healthcare delivery system that constantly demonstrates its commitment to patients, communities, physicians and employees. We conduct our operations in a fiscally responsible manner as we pursue growth and expansion to meet the lifetime needs of our patients and to contribute to the overall betterment of the region.

April 9, 2023 14

MedStar Educational Values We value our physician partners and seek

to maintain strong and respectful relationships with them as we foster a private-practice orientation.

We value research, teaching and education in an environment that fosters rapid and safe clinical innovation for the betterment of medical and surgical practice for the improvement of health status.

The Planning The Planning ProcessProcess

1. Identifying and Synthesizing Needs2. Linking to Learning Objectives3. Establishing Desired Results4. Selecting an Educational Design5. Selecting Appropriate Evaluation Mechanisms6. Building a Budget

Step 1: Conducting a Needs Assessment

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Element 2.1 – Needs Assessment What is a needs assessment?

How are needs determined?

WHC documents needs through planning minutes and notes to the file

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Element 2.1 – Needs Assessment Types of Needs

Participant needs Expert (thought leader) identified needs Needs observed in clinical practice Based on review of the literature

Synthesis of Needs Pick the most important needs Boil them down to a clear statement Demonstrate Doctrine of Linkage

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Doctrine of Linkage Perform needs assessment Synthesize the resulting needs Take each need and prepare one or more

learning objectives to address the need Clearly state the desired result of those

objectives that relate to the original need Ask related outcomes questions

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Identified NeedsAfter analyzing the Needs Assessment Data, list the

needs to be addressed by this CME activity.

Desired ResultsList the expected outcomes in terms of changed

physician knowledge, skills, performance in practice and/or patient health status.

Purpose/ObjectivesList a purpose for the activity that accomplishes

the specified needs OR list at learning objectives for each need identified. (use

attached Objectives Worksheet)

           

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Element 2.3 – Writing Learning Objectives

Purpose of learning objectives Make the intent of the course clear Provide a guide in helping some presenters develop their

topics Serve to measure the results as they are tied into the

evaluation

Must be clear and measurable

Bloom’s Taxonomy (see Handouts)

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Preparing Well-Written Learning Objectives

Decide on type of objective Select appropriate verb from Bloom’s

Taxonomy Write objective in terms of clinician behavior

or patient health improvement Make the objective measurable (. . . so that) Write the objective in the 2nd person (you or

your)

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Examples of Good Objectives Decrease cardiovascular events by

improving the cholesterol profiles on your patients with hyperlipidemia

Enhance your ability to read chest radiographs in the office so that you diagnose cardiopulmonary diseases in an accurate and timely fashion.

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WWOORRKKSSHHEEEETT (use one sheet per identified need)

Identified Need:

Step 1: Write one of more learning objectives for each identified need. Using the Educational Linkages Worksheet to view an identified need and its desired result, write at least one or more learning objectives/purpose statements for each identified need. Make the objective measurable (so that . . .) and state them from the perspective of what the physician will be expected to implement in his or her practice. Write it in the second person (you or your) so as to personalize it to the reader. Examples: (1) Decrease cardiovascular events by improving the cholesterol profiles on your patients with hyperlipidemia; (2) Enhance your ability to read chest radiographs in the office so that you diagnose cardiopulmonary diseases in an accurate and timely fashion. Learning Objective #1: Learning Objective #2: Step 2: Enter the above learning objectives into the Educational Linkages Worksheet in Column 2. Now you have demonstrated linkage between the Identified Need and Learning Objectives. Step 3: Prepare one question for each learning objective to use in this activity’s follow-up outcomes evaluation. Now you have linked the objective to the intended result. In other words, what one (or more) specific and measurable self reported action(s) would you expect a physician to have implemented two-to-three months after having participated in the CME activity? State that question below: Outcomes Question #1: Outcomes Question #2: Outcomes Question #3:

DOMAIN

Cognitive Psychomotor Affective

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LINKING IDENTIFIED NEEDS TO DESIRED RESULTS

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April 9, 2023 26

Educational Linkages Worksheet

Learning Objectives Worksheet

April 9, 2023 27

Essential Area 2 – Educational Design

Options: live activities including conferences, telephone-based live activities, enduring materials including Internet CME, published monographs, CD-ROM, video education, and journal based CME, single or multiple modalities (i.e., both a live activity and an enduring material)

Selection: based on reach, audience’s preferred style of learning, available finances

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Element 2.4 – Activity Evaluation

Purpose of Evaluation Gives faculty feedback Way to measure educational effectiveness Provides participant a form to express ways to improve

the activity for future presentations Notes learning needs for future program development

Types Pre-activity evaluation En route evaluation (“minute report”) Post-activity evaluation Follow-up (outcomes) evaluation

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Measuring Behavior Change

SELF REPORTING CHART AUDIT

Becoming a commercial supporter mantra Should be offered with every proposal . . . and be

offset by budget line item Return on Educational Investment (REOI)

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Evaluation Levels in CME

Level 1… Satisfaction or reactionHow well did physicians like the program?

Level 2… Knowledge gains or learning Were the program learning objectives met?Level 3… Performance or behavior

What changes in physicians’ practice resulted?Level 4… Impact or Outcome

What were the tangible results in terms of patient care? Level 5… Return on investment (ROI)

What were the results in terms of reduced costs or increased income?

Developing a Budget

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Guidelines for Activity Budgets

CME provider must pre-approve budget before agreeing with grantor

Budgets must have column for budgeted versus actual (see Handout)

Changes in the budget must be approved in advance by the CME provider

Other Planning Issues

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The Planning Committee Committee members

Activity Director, Director of CME or her designate, joint sponsor activity staff (if applicable)

Committee responsibilities Needs assessment Develop topics and target audience Select and communicate with faculty Determine meeting design (live vs. enduring, etc) Oversee development of activity Assure promotion is ACCME-acceptable

April 9, 2023 35

Planning Committee - 2

Meeting requirements Meet at least once in a formal session with

appropriate ongoing communication

Documentation of meetings CME Policy and Procedure Manual has sample

meeting documentation forms

The CME Planning Process

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Essential Area 3 – Essential Area 3 – AdministrationAdministration

Standards for Commercial Support

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Standards for Commercial Support

The Unholy Trinity Task Force on Industry/Provider Relations Uniform adoption of FDA Guidance, ACCME Standards, and AMA Ethical Guidelines

FDA

ACCME

AMA

April 9, 2023 39

Standards for Commercial Support (continued)

Standards for Commercial

Support

Fair-balance Scientific rigor Disclosure of

Faculty financial relationships

Discussions of unlabeled/unapproved uses

Acknowledgment of commercial support

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Social Events at CME Activities Should be < 50% of the time associated with the CME activity Toll-free physician hot line Must be incidental to the educational activity Purpose is to promote interactivity between participants and faculty $100 rule Appearance of impropriety

Revised Standards for Commercial

SupportTo Be Implemented with

Revisions in late 2004

April 9, 2023 42

5 Themes Independence Absence of Commercial Bias Disclosure of Required Information and

Relationships Appropriate Management of Funds from

Commercial Interests Appropriate Management of Advertising

and Exhibits

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Independence Disclosure of teachers, managers and planners Prohibits role of “synthesizer” where a conflict of

interest occurs COI exists when the loyalty of the individual is to the

commercial relationship and not the public interest

Prohibits supporters from being joint sponsors Important implications in joint sponsorship

relationships

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Absence of Commercial Bias

Enduring materials can no longer be distributed by the supporter of an activity

April 9, 2023 45

Disclosure of Required Information and Relationships

Disclosure now required for teachers, managers and planners

Onus to interpret conflicts of interest shifts from the learner to the provider

Refusal to make disclosure by teachers, managers and planners will disqualify them from participating in the activity

Acknowledgement of contributions cannot mention the brand name – only the company

April 9, 2023 46

Appropriate Management of Funds from Commercial Interests

“Commercial Support” is replaced with “Contributor” in ACCME lexicon

No contributed funds can go to individual gifts to physicians Acceptable social events, such as meal functions and

receptions, are allowable Funds from government entities (i.e., NIH) are not

considered contributed funds Funds from employers of physicians are not

considered contributed funds

April 9, 2023 47

Appropriate Management of Advertising and Exhibits

Nothing new

PhRMA PhRMA Code of EthicsCode of Ethics

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PhRMA Code Educational grants to providers of CME No interference in content Only modest meals that contribute to the CME

activity No sporting events, theatre or other forms of entertainment

Cost of spouse participation to be borne by physician-attendee

Consultant meetings are reined-in and locales must be appropriate to the consulting service Social events at consulting meetings must be clearly

subordinate to the purpose of the meeting

Office of the Office of the Inspector General Inspector General

(HHS) Rules(HHS) Rules

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Key Features Incorporates the PhRMA Code by

reference and thereby makes them law Equates inappropriate influencing of

physicians to federal anti-fraud laws Agents of pharmaceutical companies are

held accountable Agent or agency is one that is a committed

marketing relationship

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PhRMA Code from Handouts OIG Regulations from Handouts New Draft SCS from Handouts Social Events Checklist from Handouts Management of LOA’s

Printed Materials

Promotional brochures and

syllabus materials

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Promotional Materials Types of promotional materials

Brochures Invitation cards Letters promoting CME activities Email notices of CME activities Journal ads Recurring activity calendars

Use only the approved language in WHC’s Policy and Procedure Manual

Save-the dates are exempt from language

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Sponsorship Statement Lets the audience know who is providing

CME sponsorship/credit for the activity “Sponsored by the Washington Hospital

Center” If formally joint-sponsored, “Jointly

sponsored by the Washington Hospital Center and Cardiovascular Research Institute”

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Accreditation Statement Direct Sponsored:

“The Washington Hospital Center is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.”

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Accreditation Statement (2) Joint Sponsored:“This activity has been planned and implemented in

accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the Washington Hospital Center and Cardiovascular Research Institute. The Washington Hospital Center is accredited by the ACCME to provide continuing medical education for physicians.”

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New Credit Designation Statement“The Washington Hospital

Center designates this educational activity for a maximum of <number of credits> category 1 credits toward the AMA Physician’s Recognition Award. Each physician should claim only those credits that he/she actually spent in the activity.”

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Required Language - 3 Target audience Learning objectives Acknowledgment of commercial support Disclosure of financial relationships (only in

handouts or syllabus) Disclosure of discussion of unlabeled uses

(only in handouts or syllabus)

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Special Language for Enduring Materials

Date of issuance / re-issuance Expiration date Time to complete (same as number of

credits) Format of the educational activity Instructions on how to complete

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Sample brochures Planning documents

DOCUMENTING DOCUMENTING FACULTY FACULTY

COMMUNICATIONCOMMUNICATION

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Communication with Faculty

To provide the activity director and teachers with the information needed to carry out their responsibilities with regard to CME activities

Communicate learning objectives to teachers (include them in the development)

Assure that content is consistent with needs assessment and planning committee directives

Sample faculty letter can be found in the Handouts

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Preparing Course Materials and Handouts

Course materials and handouts include: Activity agenda/timeline Faculty biographical data Thumbnail copies of slides/notes pages Reading materials/journal articles (copyright) Other information to reinforce the objectives Post-test as applicable Post-activity evaluation form

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Financial Disclosure and Unapproved Uses/Products

Financial Disclosure: Faculty must disclose any financial

interests with industry Having an interest in industry does not

mean the presentation is void Failure to do so will result in the removal of

the faculty from the activity

April 9, 2023 66

Financial Disclosure and Unapproved Uses/Products - 2

Unapproved Products (FDA): Drugs or medical equipment Must note unapproved use for disclosure to

the participant in a MEANINGFUL WAY Allows the participant to draw their own

conclusion as to the risk/benefit of that product

April 9, 2023 67

Faculty letter formats Disclosure forms Samples of actual disclosure

Other ACCME Other ACCME PoliciesPolicies

April 9, 2023 69

New Internet CME Rules

Internet CME activity does NOT reside on the grantor’s website

Learner is notified when entering or departing the educational website

If there is a link to the grantor’s website, it is done before or after the entrance to or exit from the educational content area

There is no advertising (includes banner, subliminal and pop-up window advertisements) whatsoever within the educational content area of the website

April 9, 2023 70

Internet Rules - 2 Notice included as to type of hardware and

software needed to participate in the activity

Mechanism for learner to contact the provider is posted on the website

If the activity is hosted on a joint sponsor’s website, a hyperlink is established to the sponsor’s website

April 9, 2023 71

Guidelines for Honoraria Honoraria should be reasonable

High honoraria is a trigger for ACCME that the supporter is influencing faculty

What’s reasonable? Average today is $1,500 Able to adjust for high level speaker

April 9, 2023 72

On-site Management of Commercial Support and Exhibits

ACCME’s Policies on Commercial Support -- it is summarized in your CME P&P Manual

Of particular interest is the manner in which commercial representatives conduct themselves during the activity WHC staff on-site to manage reps Number of reps should be kept small enough to manage No sales activities are allowed in the activity area Nametags must be conference tags

Rules for exhibits…no exhibition of products in the CME activity area (same goes for product information)

April 9, 2023 73

Document, Document, Document!

The ACCME audits WHC’s files periodically

The only proof of compliance is written documentation

Permanent CME files transferred to OCME within 30 days of activity completion

74April 9, 2023

Any Questions????