Transcript Duke Case Based Approach Self Study

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
Duke Office of Continuing Medical Education
Release Date: June 1, 2005
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 nonDuke 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 [email protected] 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 ACCMEaccredited 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 ACCMEaccredited 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
an educational activity disclose their relevant financial
relationships to the ACCME-accredited Provider.
Individuals who refuse to disclose to the ACCMEaccredited 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.
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
B. No
Providing anything of value to a referring
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 supplemental payment directly from XYZ Pharma?
B. No
A. Yes
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)
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
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)
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
B. No
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)
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 relationships held by a partner or spouse
Interests of partner/spouse and children
are imputed to the discloser
Does Not need to know amount of
disclosure(s)
Cares about how much value one holds
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
B. 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.
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
B. No
The new ACCME standards require ACCMEaccredited 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.
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?
A. Yes
B. No
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)
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
B. No
A. 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 ACCMEaccredited 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 companysponsored 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. True
B. 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)
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-fb73-44d1-872580a1504e520c_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-bd1a44b2d072dc5e.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
24
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 SelfAssessment, 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: [email protected]
Duke Office of Continuing Medical Education
26