Release Date: June 1, 2005 Expiration Date: May 31, 2007

1. Duke Office of Continuing Medical Educationpresents:A case-based approach to understanding the AMA Guidelines on Gifts to Physicians, OIG, & new ACCME StandardsRead these cases and test your knowledge in this CME-certified self-study activity Release Date: June 1, 2005 Expiration Date: May 31, 2007  2005 Duke Office of CME

2. 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 1.0Category 1 credit toward the AMA Physician’s Recognition Award. Each physician should claim only those credits that he/she actually spent in the activity. Questions: Contact the Duke Office of CME (919) 684-6485 or cme@mc.duke.edu

3. 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. Authors

4. 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. Learning Objectives

5. 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. http://www.accme.org/dir_docs/doc_upload/bd51dd74-f827-4113-b54a-973272234c9e_uploaddocument.pdf

6. 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. • True • False B. False 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. Individuals who refuse to disclose to the ACCME-accredited Provider will be disqualified from participating in the CME activity. (Reference 1a on Slide 24) Note: Click anywhere on this slide to view the correct answer.

7. True False 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. 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)

8. 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? • Yes • Providing anything of value to a referring • physician could be considered to be in violation of • the Antikickback Statute. • (Reference 3 on Slide 24) • Yes • No

9. 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? • Yes • 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)

10. 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? • Yes • No • Yes • 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)

11. 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 No individual (activity medical director, planning 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) • Yes • No

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

13. 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 Ideally, all off-label uses of medications discussed should be 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) • Yes • No

14. 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? • Yes • No • 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)

15. 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: 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

16. 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? • Yes • No • Yes • 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)

17. 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? • No • The original grant agreement is a legal contract; the • department must abide by the agreement, return the • unused grant funds to ABC Pharma, and request a • new grant for the upcoming CME activity. • Yes • No

18. 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? • Yes • The new ACCME standards require ACCME- • accredited Providers to identify and resolve conflicts • of interest; a peer review process to validate the • content is an acceptable mechanism to resolve an • identified conflict of interest. • Yes • No

19. 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. • False • Needs assessment for a CME activity must be based on the • 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) • True • False

20. 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 Since this activity is not certified for Category 1 CME 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) • Yes • No

21. 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? • Yes • No • Yes • 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)

22. 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. • False • A certified CME activity should be about the diagnosis and • management of a medical condition (not about a single • drug). A fair, balanced and scientifically rigorous CME • 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) • True • False

23. 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? • Yes • No MR#14-29-55-405 • 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)

24. 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 References

25. 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) References

26. 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