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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
April 9, 2023 3
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
April 9, 2023 4
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…
April 9, 2023 6
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.
April 9, 2023 7
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
April 9, 2023 11
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
April 9, 2023 12
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.
April 9, 2023 13
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
April 9, 2023 17
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
April 9, 2023 18
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
April 9, 2023 19
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
April 9, 2023 20
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)
April 9, 2023 21
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)
April 9, 2023 22
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)
April 9, 2023 23
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.
April 9, 2023 24
LLEEAARRNNIINNGG OOBBJJEECCTTIIVVEESS// PPUURRPPOOSSEE SSTTAATTEEMMEENNTTSS
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
April 9, 2023 25
LINKING IDENTIFIED NEEDS TO DESIRED RESULTS
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DISTRIBUTEFOLLOW-UPOUTCOMES
QUESTIONNAIRE
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
April 9, 2023 28
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
April 9, 2023 29
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)
April 9, 2023 30
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
April 9, 2023 32
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
April 9, 2023 34
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
April 9, 2023 38
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
April 9, 2023 40
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
April 9, 2023 43
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
April 9, 2023 44
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
April 9, 2023 49
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
April 9, 2023 51
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
April 9, 2023 52
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
April 9, 2023 54
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
April 9, 2023 55
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”
April 9, 2023 56
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.”
April 9, 2023 57
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.”
April 9, 2023 58
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.”
April 9, 2023 59
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)
April 9, 2023 60
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
April 9, 2023 61
Sample brochures Planning documents
DOCUMENTING DOCUMENTING FACULTY FACULTY
COMMUNICATIONCOMMUNICATION
April 9, 2023 63
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
April 9, 2023 64
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
April 9, 2023 65
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????