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					   Duke Office of Continuing
      Medical Education
                                       presents:

A case-based approach to understanding the
AMA Guidelines on Gifts to Physicians, OIG,
        & new ACCME Standards
           Read these cases and test your knowledge in this
                  CME-certified self-study activity


                                                   Release Date: June 1, 2005
 Duke Office of Continuing Medical Education       Expiration Date: May 31, 2007
                                                                                1
                                                                   2005 Duke Office of CME
Target Audience: Duke Faculty and Staff

Registration Fee: No fee for Duke Faculty and Staff. Fee is $20 for non-
Duke individuals (check made payable to Duke Office of CME).

How to Receive CME Credit: Read the CME information, including the
learning objectives; read through the slides and click to read the feedback. At the
conclusion of the slide presentation, please click on the provided link in order to
complete the self-assessment, evaluation, and CME credit attestation form.

Accreditation: The Duke University School of Medicine is accredited by the
Accreditation Council for Continuing Medical Education (ACCME) to provide
continuing medical education for physicians.

Credit Designation: The Duke University School of Medicine designates
this educational activity for a maximum of 1.0 Category 1 credit toward the AMA
Physician’s Recognition Award. Each physician should claim only those credits
that he/she actually spent in the activity.
    Duke Office of Continuing Medical Education
                                                  Questions: Contact the Duke Office of CME
                                                     (919) 684-6485 or cme@mc.duke.edu 2
                                        Authors
Kathryn Andolsek, M.D., M.P.H.
Interim Associate Dean of CME
Debra L. Gist, M.P.H.
Director, CME
Brooke Johnson
CME Coordinator
Disclosure: The authors have no relevant financial relationships to disclose. No off-label uses will
    be discussed.
Disclaimer: This case-based learning activity is designed to address common situations and
    consists of hypothetical situations that are meant to be representative but not all inclusive.
    Please be certain to check with the Duke Office of CME regarding your own specific situations.
    DOCME is happy to provide Duke Faculty and Staff with a consultation regarding your planned
    activities as a service to you, even if you are not using DOCME as the accredited provider.
NOTE: Where appropriate, cases include a reference # for the source document.


    Duke Office of Continuing Medical Education
                                                                                              3
                      Learning Objectives
Following this self-study activity, participants should be able to:
• Restate examples of financial relationships that must be disclosed for a
  CME activity.
• Evaluate who needs to disclose financial relationships as part of a
  CME activity.
• Discuss antikickback issues as they relate to CME.
• Describe one method for general disclosure of off-label uses.
• Analyze whether a potential gift from industry (pharma or device
  manufacturer) meets the AMA Guidelines on Gifts to Physicians.
• Restate two examples of appropriate mechanisms that ACCME-
  accredited Providers (like DOCME) can use to resolve a conflict of
  interest.

  Duke Office of Continuing Medical Education
                                                                        4
                       ACCME Definitions
ACCME-accredited Provider: The institution or organization that is
   accredited by the Accreditation Council for Continuing Medical Education
   (ACCME) to sponsor (certify) CME activities (i.e., the Duke Office of
   CME).
Commercial Interest: Any proprietary entity producing health care goods or
   services, with the exemption of non-profit or government organizations and
   non-health care related companies.
Commercial Support: 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.
Financial Relationships: Those relationships in which the individual benefits
   by receiving a salary, royalty, intellectual property rights, consulting fee,
   honoraria, ownership interest (e.g., stocks, stock options or other ownership
   interest, excluding diversified mutual funds), or other financial benefit.
   ACCME considers relationships of the person involved in the CME activity
   to include financial relationships of a spouse or partner.
    Duke Office of Continuing Medical Education
                                                                                                5
   http://www.accme.org/dir_docs/doc_upload/bd51dd74-f827-4113-b54a-973272234c9e_uploaddocument.pdf
Case 1: A moderator for a CME-certified activity has the right to
refuse to disclose financial relationships to the ACCME-
accredited Provider and still moderate the CME activity.


A. True             B. False

B. False            The new ACCME Standards mandate that ALL
                    individuals who are in a position to control the content of
 Note: Click
 anywhere on        an educational activity disclose their relevant financial
  this slide to     relationships to the ACCME-accredited Provider.
    view the
correct answer.
                    Individuals who refuse to disclose to the ACCME-
                    accredited Provider will be disqualified from participating
                    in the CME activity.
                                                       (Reference 1a on Slide 24)

      Duke Office of Continuing Medical Education
                                                                          6
Case 2: A faculty member has been asked to serve as a committee
member to plan his division’s upcoming annual CME meeting.
Because he will only be a planning committee member and not a
speaker at the event, he does not have to disclose his relevant
financial relationships to the ACCME-accredited Provider.
A. True          B. False
B. False         Again, the new ACCME Standards mandate that ALL
                 individuals who are in a position to control the content of
                 an educational activity disclose their relevant financial
                 relationships to the ACCME-accredited Provider. This
                 includes planning committee members,
                 faculty/speakers/presenters, authors, activity medical
                 directors, moderators, etc.
                                                   (Reference 1a on Slide 24)

  Duke Office of Continuing Medical Education
                                                                      7
Case 3: A physician who refers patients to the faculty in your
division is invited by your division to a 45-minute lecture by a
well-respected clinical researcher. The activity is certified for
Category 1 AMA PRA credit by an ACCME-accredited
Provider. An educational grant has been provided to your
division by ABC Pharma, there are no registration fees, and the
lecture will take place in a baseball park just prior to a
scheduled professional game. Following the meeting, attendees
and their spouses are given free tickets to stay for the baseball
game. Could this be considered a violation of the Antikickback
Statute?
                       A. Yes
 A. Yes                Providing anything of value to a referring
 B. No                 physician could be considered to be in violation of
                       the Antikickback Statute.
                                                     (Reference 3 on Slide 24)
   Duke Office of Continuing Medical Education
                                                                       8
Case 4: ABC Pharma invites you to Whitewater Adventure, a
well known mountain resort, for a weekend of rafting and
continuing education. You will spend Saturday conquering the
river, followed by a speaker who will lead a brief medical
discussion Saturday evening. Is this offer appropriate and can
the lecture be certified for CME credit?

 A. Yes               B. No

 B. No                The time devoted to the recreation far outweighs the
                      time devoted to continuing education. This activity
                      would not be eligible for CME credit. Per the ACCME
                      Standards: “Social events or meals at CME activities
                      cannot compete with or take precedence over the
                      educational events.”
                                                    (Reference 1a on Slide 24)
   Duke Office of Continuing Medical Education
                                                                       9
Case 5: A physician is invited to participate in a 50-minute
telephone conference with colleagues on treatment issues
related to a medical condition common to her practice and to
evaluate how the company's product will impact her practice.
In recognition of participation, she will receive an anatomical
model valued at approximately $90. Is this gift appropriate?

A. Yes           A. Yes

B. No            This gift meets the AMA Guidelines on Gifts to
                 Physicians because:
                   * Its value is less than $100
                    * It will primarily benefit patients (when used as a
                      teaching/demonstration aide)
                    * There is no link to prescribing or referring patterns
                                                     (Reference 2 on Slide 24)

   Duke Office of Continuing Medical Education
                                                                      10
Case 6: A faculty member has been invited to speak at a CME
activity certified for credit by an ACCME-accredited Provider;
she agrees to accept a $1,000 speaking honorarium from the
Provider. XYZ Pharma, one of the grantors for this activity, has
offered to supplement her speaking honorarium. Since she is
spending much more time than she anticipated preparing this
presentation, is it appropriate for her to accept this supple-
mental payment directly from XYZ Pharma?
                     B. No
  A. Yes
                     No individual (activity medical director, planning
  B. No              committee member, faculty, moderator, panel members,
                     etc.) involved in a CME/CE activity may receive
                     payment directly from a commercial interest for
                     honoraria, travel or out-of-pocket expenses.
                                                     (Reference 1a on Slide 24)
    Duke Office of Continuing Medical Education
                                                                       11
Case 7: A pharmacist receives the ACCME-accredited
Provider’s Disclosure Form for a CME conference at which
he will be presenting; since he has no financial relationships
with commercial interests to disclose, he does not need to
complete and return the form.


A. True                  B. False
                         An individual who has no relevant financial
B. False
                         relationship(s) must still disclose this fact to the
                         Provider and to the learners.
                                                       (Reference 1a on Slide 24)




   Duke Office of Continuing Medical Education
                                                                         12
Case 8: A faculty member will be presenting at this year’s
annual CME conference “The ABCs of Pediatric Dermatology.”
Her presentation will include discussion of the off-label
(unapproved) uses of multiple prescription topical ointments.
Should she disclose these off-label uses to the learners?

               A. Yes
A. Yes         Ideally, all off-label uses of medications discussed should be
B. No          disclosed. However, it may be impractical to mention each
               one individually. In this case it is recommended a general
               disclosure be made to attendees prior to the presentation
               (e.g., include an introduction slide indicating “off-label uses
               will be discussed in my presentation; contact the medical
               affairs department of the manufacturer for the most recent
               prescribing information”).
                                                     (Reference 1c on Slide 24)
   Duke Office of Continuing Medical Education
                                                                       13
Case 9: A faculty member has been asked to participate as a
planning committee member for an upcoming CME activity
that will be certified for Category 1 AMA PRA credit by an
ACCME-accredited Provider. This activity will be supported
by an educational grant from XYZ Pharma. The faculty
member completes the Provider’s Disclosure Form and enters
his name and the name of XYZ Pharma. Does this meet the
ACCME’s requirements for disclosure?

 A. Yes          B. No

 B. No           Disclosure must also delineate what was received &
                 for what role (e.g., honorarium for serving as an
                 advisory board member). Note: the Provider does
                 NOT need or want to know how much was received.
                                                  (Reference 1a on Slide 24)
  Duke Office of Continuing Medical Education
                                                                    14
                   Disclosure Requirements
ACCME disclosure requirements do not supersede those of your
institution, which may be different. Two major differences
between requirements for CME disclosure and institutional
disclosure are:
              CME Disclosure                              Institutional Disclosure
  Concerned about financial relation-                Interests of partner/spouse and children
  ships held by a partner or spouse                  are imputed to the discloser

  Does Not need to know amount of                    Cares about how much value one holds
  disclosure(s)


Duke School of Medicine Conflict of Interest Policy: http://www2.mc.duke.edu/admin/aa/policy/coi.pdf
Faculty Central Website: https://faculty.duke.edu


       Duke Office of Continuing Medical Education
                                                                                              15
Case 10: A pharmacist has been asked to present on a new
class of antibiotics at an upcoming CME activity. Her spouse
is a District Manager for XYZ Pharma, a company that
manu-factures one of the drugs in this new class. Does she
need to include this information when she completes the
ACCME-accredited Provider’s disclosure form?

A. Yes             A. Yes
B. No              ACCME considers the financial relationships of a
                   spouse or partner (that the individual is aware of) to
                   also be their financial relationships.
                                                    (Reference 1a on Slide 24)



  Duke Office of Continuing Medical Education
                                                                      16
Case 11: A business manager is helping the Department Chair
plan an upcoming CME activity and learns that ABC Pharma
provided the department with an educational grant 3 years ago
to support a fellowship. The grant money was never spent; the
agreement indicated that the funds were to be returned if they
were not utilized. The District Manager from ABC Pharma has
recently informed the Department Chair that the unused funds
from the original educational grant can be applied to the
upcoming CME activity since “it’s all education.” Is this
acceptable?
                 B. No
A. Yes
                 The original grant agreement is a legal contract; the
B. No            department must abide by the agreement, return the
                 unused grant funds to ABC Pharma, and request a
                 new grant for the upcoming CME activity.

    Duke Office of Continuing Medical Education
                                                                         17
Case 12: A faculty member has been asked to present on the
“Diagnosis and Management of Acute M.I.” at an upcoming CME
activity. The ACCME-accredited Provider has identified a conflict
of interest: the faculty member is a stockholder in a company that
manufactures a new biomarker for detecting myocardial damage.
Prior to the CME activity, the Provider asks for the faculty’s
presentation materials and slides so that they can have a clinical
laboratory scientist and a cardiologist (who are both without
conflicts) review the materials for fair balance and content
validation. Is this an appropriate request by the Provider?
                        A. Yes
  A. Yes                The new ACCME standards require ACCME-
                        accredited Providers to identify and resolve conflicts
  B. No                 of interest; a peer review process to validate the
                        content is an acceptable mechanism to resolve an
                        identified conflict of interest.
    Duke Office of Continuing Medical Education
                                                                         18
Case 13: A faculty member is asked by the ACCME-accredited
Provider to document a “needs assessment” as part of a
proposed CME activity on peripheral vascular disease. This
requirement (ACCME Essential 2.2) can be fulfilled by
indicating that the academic medical center needs to market its
new equipment (service) that can screen for this condition.
            B. False
A. True
         Needs assessment for a CME activity must be based on the
B. False educational needs of the target audience. Need sources
         include: survey of target audience, incidence and prevalence
         of the disease, literature review, expert opinion, etc.
         Information from needs sources should then be analyzed and
         synthesized into a needs statement (e.g. primary care
         physicians need to be updated on the changes in the new CAP
         guidelines and how they impact practice).
                                                (Reference 1b on Slide 24)
    Duke Office of Continuing Medical Education
                                                                  19
Case 14: A physician has been asked by FGH Pharma to give a
dinner presentation to community physicians on emerging
issues in Community-Acquired Pneumonia (CAP). The
activity is not certified for Category 1 CME credit and all
logistical arrangements will be made by FGH Pharma. Is it
appropriate for the physician to speak about FHG Pharma’s
new drug, Respira, and its off-label (unapproved) use in the
treatment of CAP in this presentation?
               B. No
A. Yes
               Since this activity is not certified for Category 1 CME
B. No          credit by an ACCME-accredited Provider, it is
               considered “promotional” and the speaker should only
               discuss FDA-approved uses. Refer to Federal Register
               Vol. 62 No. 232 Dec 3 1997 for full information.
                                                       (Reference 5 on Slide 25)
   Duke Office of Continuing Medical Education
                                                                        20
Case 15: A physician has been asked to present at an activity
certified for Category 1 CME credit by an ACCME-accredited
Provider. She is asked to address the off-label (unapproved) use of
a drug as part of her presentation. Is this appropriate?

A. Yes
                  A. Yes
B. No
                  Off-label uses can be discussed in activities certified
                  for Category 1 CME credit by an ACCME-accredited
                  Provider but should be disclosed as such to the learners.
                  At an activity certified for CME credit by an ACCME-
                  accredited Provider speakers can discuss off-label
                  (unapproved) uses. However, in promotional activities,
                  speakers should only discuss FDA-approved uses.
                                                     (Reference 5 on Slide 25)

    Duke Office of Continuing Medical Education
                                                                      21
Case 16: A faculty member has been involved in company-
sponsored research of a great new drug (or device) that represents
a major treatment advance. Few, if any, adverse effects exist and
this treatment represents a totally new "drug class”. The faculty
member is planning a CME-certified presentation to publicize this
information. The presentation can focus exclusively on the
pharmacology and benefits of this new therapeutic modality.
             B. False
                 A certified CME activity should be about the diagnosis and
 A. True         management of a medical condition (not about a single
                 drug). A fair, balanced and scientifically rigorous CME
 B. False        presentation would compare and contrast this new drug (or
                 device) with the current standard of care, delineate the
                 indications and contraindications of all therapies, their
                 risks and benefits, discuss treatment costs, etc. (e.g., a fair,
                 balanced, and scientifically rigorous review of therapeutic
                 options for this medical condition based on the highest level
                 of evidence).                   (References 1a & 1b on Slide 24)
    Duke Office of Continuing Medical Education
                                                                         22
Case 17: A physician at a large teaching hospital is giving a
presentation to an external audience. He plans to include the
slide below as part of his educational presentation. Is this
slide HIPAA compliant?

A. Yes
B. No
      B. No
      This image contains the Medical Record # (a faux MR# was added to
      this image obtained from: http://sln.fi.edu/biosci2/monitor/images/xray.jpg).
      When patient information is used for educational purposes, you
      must remove information that could identify the patient (e.g. MR
      #, SSN, DOB, etc) OR obtain the patient’s written consent to
      have the information used for educational purposes.
                                              (Reference 7 on Slide 25)
  Duke Office of Continuing Medical Education
                                                                                 23
                                     References
1: Accreditation Council for CME (www.accme.org)
   1a: Standards for Commercial Support
   http://www.accme.org/dir_docs/doc_upload/68b2902a-fb73-44d1-8725-
   80a1504e520c_uploaddocument.pdf
   1b: Essential Areas and Elements
   http://www.accme.org/index.cfm/fa/EssentialAreas.home/EssentialAreas.cfm
   1c: Content Validation Statement
   http://www.accme.org/index.cfm/fa/Policy.policy/Policy_id/16f1c694-d03b-4241-bd1a-
   44b2d072dc5e.cfm


2: American Medical Association (www.ama-assn.org)
   What you should know about Gifts to Physicians from Industry
   http://www.ama-assn.org/ama/pub/category/8405.html


3: Office of Inspector General (http://oig.hhs.gov/)
   Compliance Program Guidance for Pharmaceutical Manufacturers
   Duke Office of Continuing Medical Education
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                                      References
4: AdvaMed (www.advamed.org/)
  Code of Ethics on Interactions with Healthcare Professionals


5: Food and Drug Administration (www.fda.gov/cber/gdlns/sciedu.pdf)
  Final Guidance on Industry-Supported Scientific and Educational Activities.
  Federal Register Vol. 62 No. 232 Dec 3 1997.


6: PhRMA (www.phrma.org/)
  Code on Interactions with Healthcare Professionals


7: U.S. Department of Health & Human Services
  (www.hhs.gov/ocr/hipaa/)
  Standards for Privacy of Individually Identifiable Health Information (HIPAA)

    Duke Office of Continuing Medical Education
                                                                           25
                              Evaluation
 Please click on the link below to complete a Self-
    Assessment, Evaluation, and CME Credit
                 Attestation Form.
 Note: CME credit for this self-study activity is free to Duke Faculty and Staff;
fee is $20 for Non-duke individuals (please make check payable to Duke Office
 of CME, 3100 Tower Boulevard, Suite 1300, Durham, NC 27707). Thank you.


https://Docme.mc.duke.edu/pdc_data/duke_case_based_approach_self_study.htm


     Questions: Please call (919) 684-6485 or e-mail: cme@mc.duke.edu

   Duke Office of Continuing Medical Education
                                                                             26

				
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