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Code of Conduct
Preamble
The continually evolving environment of continuing education for health care
professionals necessitates that all stakeholders must be accountable for
designing, implementing, and evaluating quality education that improves patient
care. Such education enhances the integrity of the continuum of the medical
education and can best be developed by professionals who rely on best practices
and comply with all relevant guidelines.
The continuing medical education (CME) profession has made great strides in
recent years. Providers, educational partners, and other stakeholders have
adapted as health care has evolved and rules and regulations, including the
updated Standards for Commercial Support, new accreditation criteria, and recent
policy revisions of the Accreditation Council for CME (ACCME) have been updated[1].
Although many guidance documents already exist for various stakeholders within
the CME enterprise, they are at times contradictory, and in other instances
incomplete. Commercial supporters and their actions, including funding of
education, remain under intense regulatory and public scrutiny; at the same
time, educational providers face higher hurdles in developing appropriate,
innovative, impactful education that improves clinical performance and patient
outcomes.
Ensuring that healthcare professionals have the latest, most accurate
information—and the ability to apply it in their practices—is critical to
improving patient care. The purpose of this Code of Conduct (CoC) is to promote
best practices in commercially supported CME to improve clinician performance
and to enhance patient care and outcomes. This document represents a broad view
of best practices in developing medical education that is certified for CME
credit. The intended audience for this CoC includes medical education providers
(both accredited and non-accredited) and commercial supporters. This document
provides recommendations that will require interpretation and application by
each stakeholder organization in the context of its own operating environment,
resources, and strategic imperatives.
The CoC is designed to be consistent with and complementary to:
Federal Statutes such as The False Claims Act[2] and the Anti-Kickback
Statute;[3] Federal regulations including The Food and Drug Administration (FDA)
Final Guidance for Industry Supported Scientific and Educational Activities (FDA
Guidance),[4] and The Office of Inspector General (OIG) Compliance Program
Guidance (CPG) for Pharmaceutical Manufacturers.[5]
State regulations such as Nevada 2007 Bill Text NV A.B. 128, and 2007 Bill
Tracking NV A.B. 128., California Health and Safety Code §§ 119400-119402 (the
California Compliance Program Law), and Massachusetts’ Gift Law, Mass. Gen. L.
c. 111N.[6]
Policies of organizations such as the ACCME[7] (Standards for Commercial
Support and Accreditation Policies Including Tools for Implementation), the
American Medical Association (Code of Medical Ethics,[8] (Continuing Medical
Education Opinion 9.011 and Gifts to Physicians from Industry Opinion 8.061)),
the Pharmaceutical Research and Manufacturers of America (PhRMA Code on
Interactions with Healthcare Professionals (2008, Revised PhRMA Code)),[9]
Advanced Medical Technology Association (AdvaMed Code of Ethics on Interactions
with Healthcare Professionals (2008, Revised AdvaMed Code)),[10] and North
American Association of Medical Education and Communication Companies, Inc. (NAAMECC
Code of Ethics).[11]
Recommendations
Compliance Program Elements from the OIG CPG
Providers and supporters are strongly encouraged to comply, as appropriate, with
the seven elements of an effective compliance program as defined by the OIG:
- implementing written policies and procedures,
- designating a compliance officer and/or compliance committee,[12]
- conducting effective staff training and education,
- developing effective lines of communication, including an anonymous
reporting function (for staff),
- conducting internal monitoring and auditing,
- enforcing standards through well-publicized disciplinary guidelines, and
- responding promptly to detected problems and undertaking corrective
action.[13]
Independence
Guidelines and Standards
Providers and supporters must follow all relevant rules, regulations, and
guidelines.
- A commercial interest cannot take the role of non-accredited partner in a
joint sponsorship relationship.[14]
- Providers and supporters should take steps toward ensuring that all
aspects of continuing education activities are free of commercial and
scientific bias.[15]
- Financial support for an educational activity must not be given as an
inducement for faculty or participants of the activity to prescribe or
recommend a particular medication, device, or course of treatment.[16]
- Supporters should develop objective criteria for making CME grant
decisions to ensure that the activities funded by the company are bona fide
educational interventions.[17]
- Accredited providers must ensure that the following decisions are made
free of the control of a commercial interest:
- identification of educational needs (knowledge and performance gaps),
- determination of educational objectives,
- selection and presentation of content,
- selection of all persons and organizations that will be in a position to
control the content of the activity,
- selection of educational methods, and
- evaluation of the activity.[18]
- Providers and supporters must ensure their compliance with independence
factors as described by the FDA including:
- control of content and selection of presenters and moderators,
- disclosures,
- focus of the activity,
- relationship between provider and supporting company,
- provider involvement in sales or marketing,
- provider’s demonstrated failure to meet standards,
- multiple presentations,
- audience selection,
- opportunities for discussion,
- dissemination,
- ancillary promotional activities, and
- complaints.[19]
- Effective separation of education and marketing by both providers and
supporters will help ensure that grant funding is not inappropriately
influenced by sales or marketing motivations and that the educational purposes
of the grant are legitimate.[20]
- Supporters should separate their CME grant-making functions from their
sales and marketing departments.[21]
- Providers should not engage in discussions with supporters’ marketing
and sales personnel regarding educational priorities, strategies, or grants.
Corporate Structure
- Provider firewalls
- In accordance with ACCME polices, commercial interests cannot be
accredited providers and cannot be joint sponsors.[22]
- Providers and educational partners that are part of larger corporate
structures (eg, those with a sibling that is a commercial interest) must
have formal firewall policies that ensure physical and functional separation
between organizations and individuals responsible for the content of
independent medical education and those providing promotional or strategic
services to commercial interests.[23]
- Sharing of services among “parent/sibling” organizations:
- Sharing services related to faculty interaction and content
development (eg, medical writing, medical direction, substantive editing)
among related organizations should be prohibited.
- Staff and/or freelancers who control content for promotional education
should wait an appropriate length of time (eg, a “wash-out” period of 6 to 12
months) before working on educational content in the same therapeutic area.
Accredited providers should verify this “wash-out” for staff who control
content. No such “wash-out” period is needed for staff moving from educational
to promotional work.
- The work of provider staff and freelance writers in assisting faculty
with content development should be acknowledged and disclosed.
- To reduce the risk that funding for educational activities is used
improperly to induce or reward product purchases or to market products
inappropriately, supporters should separate their grant making function from
their sales and marketing functions.[24]
Identification, Disclosure, and Resolution of Conflict of Interest
- Financial relationships are a reality and can have both positive and
negative consequences. It is not practical nor realistic to entirely prevent
conflict of interest; rather it should be aggressively identified, disclosed,
and resolved. Many organizations (eg, AAMC, ABIM, ACCME, AUA, FASEB, ICMJE)
have described effective approaches to do so.[25]
- Accredited providers must be able to show that everyone who is in a
position to control the content of an educational activity has disclosed to
the provider all relevant financial relationships with any commercial
interest.[26] Providers should collect this information annually, to maintain
internal documentation that is current and appropriate.
- Providers and educational partners should also disclose all financial
relationships that their organization has with commercial interests relevant
to each educational activity.
- Providers, educational partners, and supporters should adopt policies
and practices to ensure transparency of their relationships.
- Providers must have implemented a mechanism to identify and resolve all
conflicts of interest prior to the educational activity being delivered to
learners.[27] Conflict resolution strategy may include one or all of the
following: (1) requiring faculty to rely only on peer-reviewed, evidence-based
data; (2) not allowing faculty to present “data on file” or other unpublished
information; (3) having qualified provider staff review content for balance,
completeness, and relevance, and/or validate (fact-check) all information
against cited references; (4) having faculty review each other’s content; (5)
contracting with independent peer reviewers; (6) restricting faculty to
discussion of data for which they have no financial interest; (7) allowing
faculty to present only non-clinical scientific data (no discussion of
treatment options or patient care recommendations).[28]
- Providers should have in place procedures to deal with faculty who,
despite appropriate measures on the part of the provider, demonstrated a
conflict of interest during a live activity.
- Providers should educate their staff, faculty, educational partners, and
other stakeholders to more effectively identify, disclose, and resolve
conflicts of interest.[29]
Monitoring for Bias
- Bias in its many forms—scientific, institutional, and personal, in
addition to commercial—cannot reasonably nor practically be entirely
prevented.[30]
- Providers should collaborate with faculty to minimize and, when possible,
prevent all types of bias.
- Providers should have mechanisms in place to identify potentially biased
content and to ensure that all patient care recommendations are evidence based
and in the best interest of the public. (See quality control section below)
- Providers should monitor for the existence of bias, and the perception
that bias exists, in all certified CME activities.[31] (See also quality
control section below)
- Providers could ask participants to evaluate completed activities for
the nature and extent of commercial bias; providers should strive to obtain
useful information about bias, if participants indicate the presence of bias
they should be asked to characterize it.
Appropriate Grant Activities: Request, Review, and Funding
Designate Controls and Guidelines for Seeking/Providing Support
- Providers should submit and supporters should receive and review, grant
requests in accordance with ethical business practices and in compliance with
all relevant guidelines.
- Supporters and providers must refrain from offering or accepting payment,
inappropriate gifts, or other forms of compensation to secure work or
influence professional judgment.[32]
- The accredited provider and joint sponsor (if any) should be identified in
the grant request.
- Supporters should establish objective criteria for reviewing and approving
grant requests. These criteria should ensure that the funded activities are
bona fide. Criteria must not take into account the volume or value of
purchases made by, or anticipated from, the grant recipient and/or anticipated
faculty or learners.[33]
- Providers should attempt to reduce reliance on industry support and seek
alternate funding mechanisms.
Information to be Included in Grant Requests
- Providers should be expected to explain, and supporters should be expected
to evaluate, the identified knowledge/performance gaps and method of assessing
them, target audience, learning objectives and desired outcomes, educational
methods and rationale, faculty selection process, assessment/evaluation plan,
timeline, budget, and quality control processes and qualifications of provider
(and partner) staff and planners.
Budgeting
- Supporters may ask that providers use a standardized budget template.
Templates, if supplied by the supporter, should be appropriate for the type
and scope of proposed activities, eg, templates should accommodate live events
as well as enduring materials, and a continuum of learning in addition to
single activities.
- Supporters should ask for and providers should supply a reasonable and
appropriate level of detail regarding estimated fees and expenses (not
including hourly rates and estimated hours).
- If a grantor provides partial funding (eg, approves less funds than
requested by the provider), the provider should revise the scope of the
activity (eg, deliverables, milestones, timeline) accordingly and request
confirmation that the supporter will fund the revised activity.
- Once a grant request is approved, the need for and amount of budget
modification (if any) should be identified by the provider as soon in the
activity planning process as possible and communicated to the supporter.
- Providers should exercise appropriate fiduciary responsibility in creating
budget estimates and in planning, executing, evaluating, and reconciling
educational activities.
Budget Reconciliation
- As per good business practice, providers and educational partners (if any)
should periodically monitor actual activity costs against the approved grant
request and budget.
- Supporters may require budget reconciliation; fees and expenses should be
reconciled at the conclusion of the activity, and a summary report should be
submitted to the supporter in accordance with the parties’ LOA.
- Requesting such a reconciliation does not represent an attempt to
control the activity, but rather a mechanism to meet fiduciary obligations
to ensure that the grant funds have been used for the intended (and
applied-for) purpose.
- Reasonable rates and fair market value (FMV)
- Activity-related expenses should be reasonable and appropriate.
- Providers should maintain accurate, comprehensive, and truthful
records of all time and expenses used in planning, executing, and
evaluating educational activities.
- Providers should determine FMV for all expenses including faculty
honoraria and include estimates of these costs at FMV in all budgets.
- Accredited providers must have and follow a policy regarding faculty
honoraria.
- Providers are encouraged (as are their supporter counterparts who are
required by OIG CPG) to review arrangements for faculty services to ensure
that
- the arrangement is set out in writing,
- there is a legitimate need for the services,
- the services are provided,
- the compensation is at FMV, and
- all of the preceding facts are documented prior to payment.[34]
Payment Terms and Use of Funds
- Supporters, providers, and educational partners (if any) should agree on
reasonable and appropriate grant disbursement terms and document them in the
grant request and/or Letter of Agreement (LOA).
- Partial grant disbursement may be made by the supporter at reasonable
milestones based on the amount of the overall grant, complexity of activity
planning and execution, timeline for completion of activities, and resources
of the provider and partners.
- Supporters, based on their fiduciary responsibility, may request assertion
(or in some cases documentation) from providers that work is taking place and
is consistent with the submitted and approved grant request. The purpose of
such documentation may not be to manage, supervise, or administer the
activity, but rather to ensure that the grant funds are being substantially
utilized for their intended purpose and in the intended manner.
Request for Information and Calls for Grant Application
- Supporters may issue a Request for Information (RFI) to a subset of
providers, or to the entire provider community, to ensure relevant information
about providers (eg, therapeutic expertise, staff qualifications, and
accreditation status) is maintained.
- Supporters may issue a Call for Grant Applications (CGA) to a subset of
providers, or to the entire provider community, to invite grant requests in
situations in which funding is available and legitimate educational needs
exist but have not been met by submitted grant requestsor when time
sensitivity requires the submission of a grant request within a short period,
as is the case with certain medical society meetings.
- CGAs may not contain information about marketing objectives or the
supporter’s promotional strategy.
- CGAs may include the general topic (eg, therapeutic area) for which
funding is available, amount of available funding, a brief description of
perceived educational needs (full needs assessment and gap analysis to be
conducted by the provider), and a timeline for grant review and approval (eg,
in connection with a medical meeting).
Selecting Appropriate Providers and Supporters
Role of Accredited Provider, Joint Sponsor, and Vendor
- Accredited providers must be accountable for planning, executing, and
evaluating activities as defined by ACCME.[35]
- Accredited organizations may delegate activities (eg, project
management, content development and validation, creative design, financial
management, outcomes assessment) to joint sponsors or other educational
partners, based on the core competencies and resources of all collaborating
groups; roles and responsibilities for all parties should be clearly defined
and confirmed by all collaborating parties.
- Accredited providers and educational partners (if any) should be
acknowledged in grant requests, LOAs, and activity materials.
- Providers and/or educational partners may contract work to other partners
who provide services (eg, printing, fulfillment, meeting planning, Web
hosting, participant recruitment) to them in the execution of an educational
activity.
- Supporters must not influence accredited providers in their selection of
educational partners and/or vendors for educational activities for which
they are providing educational grant support.
- Logistics partners and other vendors are not typically acknowledged in
grant requests or educational materials; these groups may be acknowledged,
if appropriate, given their unique competencies, services, technologies,
etc…
- Supporters should not refer to providers and joint sponsors as vendors
because this implies a relationship that does not comply with ACCME SCS.
(See definition of terms below)
Supporter and Provider Attributes
When considering entering into a grant funding relationship, grantors and
providers should evaluate the following factors to select appropriate
counterparts.[36]
- Independence (See previous section on independence)
- Compliance
- Statement of compliance with industry standards; endorsement of and
self-certification of compliance with relevant Codes of Ethics and other
regulations
- Transparency policy and/or practice
- Organizational structure
- Firewalls (See previous firewall section)
- Provider and supporter history
- Historical compliance with industry standards
- Provider accreditation status
- Previous violation(s)/probation(s)
- Previous settlements
- Terms of Corporate Integrity Agreement (if any)
- Handling irregularities and complaints
- Communication channels
- Corrective protocols
- Disciplinary protocols
- Follow-up
- Collective staff competencies
- Scientific (eg, PhD, MD, RN, MSN, PharmD, etc.) and educational (eg, EdD,
MEd) credentials
- Licensure and professional certification (eg, CCMEP)[37]
- Employment history
- Professional development and training
- Membership and active participation in CME associations such as
Alliance for CME (and its member sections), Society for Academic
Continuing Medical Education (SACME), North American Association of
Medical Education and Communication Companies (NAAMECC), Association for
Hospital Medical Education (AHME), and Council of Medical Specialty
Societies (CMSS)
- Record of publications and presentations regarding CME
- Additional professional development activities and engagement in the
CME community
- Other employee training regarding CME
- Supporters: field-based, commercial, and clinical personnel
- Providers: staff shared with sister/parent organizations
Education Design and Implementation
Content
- Control of content
- Accredited providers must ensure that the following decisions are made
free of the control of a commercial interest:
- identification of CME needs,
- determination of educational objectives,
- selection and presentation of content,
- selection of all persons and organizations that will be in a position
to control the content of the CME,
- selection of educational methods, and
- evaluation of the activity.[38]
- Supporters can have no role in recommendation or selection of faculty,
or in content review prior to an activity.
- Activity focus
- Content should maintain, develop, or increase the knowledge, skills,
professional performance, and relationships that a physician uses to provide
services for patients, the public, or the profession. Educational content is
that body of knowledge and skills generally recognized and accepted by the
profession as within the basic medical sciences, the discipline of clinical
medicine, and the provision of health care to the public.[39]
- Activities should not focus on a single product (or a competing product)
except when the existing treatment options are so limited as to preclude
meaningful discussion of alternative therapies.
- The title of the activity should fairly and accurately represent the
scope of the activity.[40]
- Fair balance[41]
- Providers and faculty should make every effort to ensure that data
regarding specific products (or competing products) are objectively selected
and presented, with favorable and unfavorable information, and balanced
discussion of prevailing information on the product(s) and/or alternate
treatments.
- Content validation
- Providers are responsible for validating the clinical content of CME
activities that they certify for credit. All the recommendations involving
clinical medicine in an activity for CME credit must be based on evidence
that is accepted within the profession of medicine as adequate justification
for their indications and contraindications in the care of patients. All
scientific research referred to, reported in, or used in CME in support or
justification of a patient care recommendation must conform to the generally
accepted standards of experimental design, data collection, and
analysis.[42]
- Providers and educational partners (if any) should review data included
in educational content for appropriateness, completeness, relevance, and
fair balance.
- Limitation of data
- Providers and faculty should ensure disclosure of limitations of data (eg,
ongoing research, interim analyses, and preliminary data).
- Providers should communicate to faculty the importance of citing
peer-reviewed, evidence-based data.
- “Data on file” should not be used in educational materials because the
data is by definition not peer-reviewed, cannot be verified, and is not
accessible to learners for further study.[43]
- Quality control processes
- Providers should assist faculty in meeting their responsibility to
ensure accurate, complete, fair balanced, relevant, scientifically rigorous
content.
- Authors and speakers have ultimate responsibility for content including
reference selection; however, providers are responsible to ACCME for
compliance with its policies.
- The roles of the provider and faculty are critically important since the
ACCME prohibits supporter review of content.
- Providers and educational partners (if any) should review content for
accuracy, appropriateness, completeness, relevance, fair balance, and
non-promotional nature of data. All reviewers should disclose relevant
relationships to the provider, and any conflicts of interest (either
financial or institutional) should be resolved prior to review.
- Providers and all educational partners should also disclose all
relevant financial relationships.
- Providers should consider the use of external (independent) peer
review systems.[44]
- Providers and partners should have qualified (eg, appropriately
credentialed or experienced) staff or consultants fact-check all content
against cited references to ensure appropriate data interpretation.
- Providers should explain their quality control processes in grant
requests; supporters should ask providers to explain their quality control
process as part of grant requests.
- Providers, partners, and faculty should follow good business and legal
practices regarding intellectual property and copyright and ensure that
permission is obtained to use previously published material.
Selection of Moderators, Speakers, Authors, Editors, and Planners
- Identification and recruitment by provider/educational partners
- A provider cannot be required by a supporter to accept advice or
services concerning faculty, participants, or other educational matters,
including content, from a commercial interest as a condition of funding.
- Supporters must not influence accredited providers in their selection of
educational partners and/or vendors for educational activities for which
they are providing educational grant support.
- Qualifications (ie, scientific and educational expertise)
- Faculty and planners should be qualified to serve in their important
roles. Attributes that might be evaluated and considered by providers and
partners are similar to those listed in the section above regarding
selecting appropriate providers and supporters these include: education and
training, work experience, prior publications and presentations, activity
and leadership among relevant societies and professional organizations,
educational expertise, participant evaluation data from previous activities,
and referrals from learners and other faculty.[45]
- Providers should encourage faculty to remain current regarding CME rules
and regulations and should provide faculty training and/or access to formal
CME faculty training programs such as the National Faculty Education
Initiative.[46]
- Eligibility to participate in federal/state health care programs
- Faculty should not be selected that are excluded or debarred persons or
entities, such as those listed on the web sites of the:
- Providers and supporters should be aware of the implications of the
Lobbying Disclosure Act and ensure that funded educational activities do not
implicate it (or, if applicable, ensure appropriate disclosures).[47]
Audience Identification and Recruitment
- The provider is responsible for identifying and recruiting the target
audience for educational activities, based upon the identified educational
needs.
- Providers may wish to seek assistance from supporters in recruiting
participants. Supporter-assisted recruitment should supplement the provider’s
overall promotional plan for an activity and should not be the primary
mechanism of audience generation.[48]
- Requests for supporter assistance with recruitment should be made in
writing[49] in advance of initiating the recruitment processes and prior to
publication of any materials.
- Supporter assistance with recruitment is appropriate before a live
activity or before the “launch” of an enduring material; once the content of
an enduring material is public, supporter involvement in recruitment should
cease.
Educational Design
- Use of evidence-based instructional design
- Providers should seek to develop (and supporters should seek to fund)
whenever possible activities that address identified gaps in knowledge,
competence, and/or performance, are interactive and incorporate active
learning techniques, are part of a sequenced continuum of learning, are
responsive to the audience’s stage of learning and readiness to change,
address barriers to change, and include reminders and reinforcers of
educational content.[50]
- Educational methods should include those found to be effective;
supporters should ask for and providers should explain their rationale for
educational recommendations in grant requests.[51]
- Providers will ensure that opportunities for meaningful discussion or
questioning are provided during live activities.[52]
- Venue and social events
- Venues must be conducive to learning and appropriate for the
audience.[53] Providers and educational partners are encouraged to assess
taste, tone, and public perception associated with the venue and ancillary
activities before entering into contracts for educational activities.
- Destination resorts and lavish venues are generally not appropriate
venues for continuing education activities.
- Social events, meals, and/or other activities ancillary to the
educational event must be subordinate to and not conflict with or take
precedence over the education; the agenda for live events must appropriately
allocate time, with education being of primary importance.
- Providers at their own discretion may use support provided through an
educational grant for a CME event to offer modest meals for
participants.[54]
- Meals (if any) in conjunction with CME events[55] should be
appropriate and modest.
- Providers should not request grants to support meals without
appropriate associated educational interventions.
Education Outcome Assessment
- ACCME—and good educational design—require providers evaluate the outcomes
of educational activities.
- Providers should design post-activity assessment studies to measure
attainment of the learning objectives and desired outcomes of the educational
activity; providers should strive to measure outcomes at the highest possible
and appropriate level for each activity.
- Providers should provide a summary report of the evaluation data and
identified outcomes to the supporter and other stakeholders (eg, faculty).
Associated Commercial Promotion
- Educational event space allocation (eg, for symposia held in conjunction
with a national conference or for journal CME) should not be contingent upon a
supporter’s purchase of exhibit space or advertisement, support for the
national conference, or based on points related to amount of commercial
support provided to the society or publisher.
- Contracting and paying for exhibit or advertising space should be separate
from contracting and paying for educational space and separate from the
educational grant application.
- Publishers and medical societies (unless they are the accredited
provider) should not discuss educational events with supporters.
- Supporters should not pay directly, and publishers and medical societies
(unless they are the accredited provider) should not accept, fees for space
for educational activities from supporters; it is the provider’s
responsibility to coordinate all educational planning and manage associated
finances.
- Symposia “slot fees” should be included in the overall grant for the
educational event.
- Publishers and medical societies should not grant space for educational
events based on the grantor’s support (or lack thereof) of advertising or
exhibits.
- Fees for educational or exhibit space should reflect FMV.
- Supporters should not approve grant requests contingent upon exhibit or
advertising opportunity.
Transparency
- Supporters and providers should institute transparency and disclosure
policies and practices.[56]
- Providers, educational partners, and logistic partners should understand
and accept the disclosure/transparency obligations of the supporters of their
activities.[57]
- LOAs should not prohibit public disclosure of funding of educational
grants by either the supporter or provider.
- Providers are encouraged to assist faculty in complying with their own
institution’s disclosure policies (if any).
- The work of provider staff and freelance writers in assisting faculty with
content development should be acknowledged and disclosed.
Adoption Mechanisms
- Providers and supporters are encouraged to certify adoption of and
compliance with this CoC.
- Supporters are encouraged to include adoption of this CoC as a criterion
for soliciting and granting funding request.
- Providers are encouraged to request grants from supporters who adopt this
CoC.
- Providers are encouraged to collaborate with educational partners who
certify compliance with the CoC.
- Certification statements should be signed by organizations’ Chief
Executive Officer and Chief Compliance Officer or individual(s) with
equivalent responsibilities.
Acknowledgements
This CoC was developed though the partnership of NAAMECC and Polaris
Management Partners.
The NAAMECC is a not-for-profit 501(c)(6) organization whose mission is to
represent, advocate for, and educate its members—medical education and
communication companies (MECCs) and the persons who work for them. The NAAMECC
Board of Directors endorsed this Code on August 31, 2009.
Polaris Management Partners (Polaris) is a management consulting firm developing
health care law compliance solutions for life sciences companies.
Principle contributors to the Code were the CME CoC Task Force Chair Karen
Overstreet, EdD, RPh, FACME, CCMEP, Executive Director of Lippincott CME
Institute, Inc. and a Founder and Past President of NAAMECC, and Andy Bender,
MBA, MSc, President of Polaris Management Partners, LLC and Jaimee Reid, JD, LLM,
Consultant at Polaris.
The following members of the CME CoC Task Force provided valuable feedback on
the outline and first draft of this document: Providing feedback on the draft
does not constitute endorsement or adoption.
- Germaine Aprill, PharmD, Astellas
- Christine Beebe, MS, RD, CDE, Takeda Pharmaceuticals
- Winnie Brown, MPA, CPMSM, CCMEP, Research Medical Center
- Linda Coogle, MBA, CCMEP, Clinical Care Options and NAAMECC Treasurer
- David Davidovic, BSc, MBA, Genentech
- Mila Kostic, University of Pennsylvania School of Medicine
- Robert Meinzer, New Jersey Academy of Family Physicians
- Lisa Miller, PharmD, Purdue Pharma
- Laura Muttini, RPh, MBA, CCMEP, Abbott
- Dave Pieper, PhD, Wayne State University School of Medicine
- Lawrence Sherman, FACME, CCMEP, Physicians Academy
- Jason Singer, PharmD, CCMEP, Eli Lilly
- Deborah Sutherland, PhD, University of South Florida
- Karen Thompson, CMP, CCMEP, American College of Cardiology
Abbreviations
- AAMC: Association of American Medical Colleges
- ABIM: American Board of Internal Medicine
- AUA: American Urological Association
- AHME: Association for Hospital Medical Education
- ACCME: Accreditation Council for Continuing Medical
Education
- AdvaMed: Advanced Medical Technology Association
- AMA: American Medical Association
- CGA: Call for Grant Application
- CME: Continuing Medical Education
- CCMEP: Certified CME Professionals
- CMSS: Council of Medical Specialty Societies
- CoC: Code of Conduct
- CPG: Compliance Program Guidance
- EPLS: Excluded Parties List System
- FDA: US Food and Drug Administration
- FASEB: Federation of American Societies for Experimental
Biology
- FMV: Fair Market Value
- GSA: US General Service Administration
- ICMJE: International Committee of Medical Journal Editors
- IOM: Institute of Medicine
- LOA: Letter of Agreement
- MECC: Medical Education and Communication Companies
- NAAMECC: North American Association of Medical Education
and Communication Companies, Inc.
- NIH: National Institutes of Health
- OIG: Office of Inspector General
- RFI: Request for Information
- SACME: The Society for Academic Continuing Medical
Education
- SCS: Standards
HTML clipboardFootnotes
[1]
NAAMECC, NAAMECC Statement for IOM Committee on Conflict of Interest in
Medical Research, Education, and Practice, March 13, 2008 (hereinafter
NAAMECC Statement on COI for IOM).
NAAMECC, Draft Copy: Choosing Educational Partners: Keys to Successful CME
Collaboration, Working Group on Collaboration, available
HERE
(PDF) (hereinafter NAAMECC Choosing Partners).
ACCME Standards for Commercial Support (SCS), Standards to Ensure the
Independence of CME Activities, available at
http://www.accme.org/dir_docs/doc_upload/68b2902a-fb73-44d1-8725-80a1504e520c_uploaddocument.pdf
(hereinafter ACCME SCS).
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[2]
42 U.S.C. § Sec. 3729-3733
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[3]
42 U.S.C. § 1320a-7b
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[4]
Food and Drug Administration, FDA Guidance for Industry, Industry Supported
Scientific and Educational Activities, available at http://www.fda.gov/RegulatoryInformation/Guidances/default.htm (hereinafter FDA Guidance).
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[5]
Office of Inspector General’s Compliance Program Guidance for Pharmaceutical
Manufactures, 68 Fed. Reg. 23731-23743 (May 5, 2003), available at
http://oig.hhs.gov/authorities/docs/03/050503FRCPGPharmac.pdf
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[6]
California, Massachusetts and Nevada, have adopted marketing statutes and
regulations that incorporate the PhRMA Code and/or the AdvaMed Code.
Additionally, the District of Columbia has incorporated the PhRMA Code into its
new pharmaceutical detailer licensing regulations. It is likely that additional
states will pass similar statutes in the future.
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[7]
ACCME SCS supra note 1; ACCME Accreditation Policies Including Information
for Provider Implementation, available at
http://www.accme.org/index.cfm/fa/Policy.home/Policy.cfm (hereinafter ACCME Policies).
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[8]
AMA’s Code of Medical Ethics, Council on Ethical and Judicial Affairs (CEJA),
Continuing Medical Education Opinion 9.011 & Gifts to Physicians from Industry
Opinion 8.061, the Pharmaceutical Research and Manufacturers of America
available at
http://www.ama-assn.org/ama1/pub/upload/mm/Code_of_Med_Eth/amacode_home.html
(hereinafter AMA Code).
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[9]
PhRMA Code on Interactions with Healthcare Professionals (Revised 2008),
available at
http://www.phrma.org/files/PhRMA Marketing Code 2008.pdf (PhRMA Code).
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[10]
AdvaMed, Code of Ethics on Interactions with Health Care Professionals,
available at
http://www.advamed.org/NR/rdonlyres/61D30455-F7E9-4081-B219-12D6CE347585/0/AdvaMedCodeofEthicsRevisedandRestatedEffective20090701.pdf
(hereinafter AdvaMed Code).
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[11]
NAAMEC Code of Ethics, available
HERE (hereinafter NAAMECC Code of Ethics).
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[12]
68 Fed. Reg. 23731-23743, supra note 5. The compliance elements are OIG
inspired and do not contain the exact wording of the original. The original text
reads:
- Implementing written policies and procedures;
- Designating a compliance officer and compliance committee;
- Conducting effective training and education;
- Developing effective lines of communication;
- Conducting internal monitoring and auditing;
- Enforcing standards through well-publicized disciplinary guidelines; and
- Responding promptly to detected problems and undertaking corrective
action.
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[13]
NAAMECC statement on COI for IOM. To enhance their ability to
demonstrate exemplary compliance with ACCME and other regulations. Many MECCs
have adopted formal compliance programs similar to those recommended by the OIG
for biopharmaceutical companies. Data from the most recent MECC survey show
that: 75% have a formal compliance program in place; 10% have a compliance
program in development; 90% of those with a compliance program report that it
includes monitoring; 90% report including training as part of their program; 69%
have appointed a compliance officer; 41% have established confidential
mechanisms by which employees can report noncompliance.
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[14]
ACCME SCS § 1.2, supra note 1.
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[15]
NAAMECC Code of Ethics, supra note 11.
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[16]
PhRMA Code § 4, supra note 9.
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[17]
Id.
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[18]
ACCME SCS § 1.1, supra note 1.
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[19]
FDA Guidance, supra note 4.
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[20]
68 Fed. Reg. 23731-23743, supra note 5.
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[21]
PhRMA Code § 4, supra note 9.
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[22]
ACCME Policies, supra note 7.
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[23]
NAAMECC Statement on COI for IOM, supra note 1.
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[24]
PhRMA Code § 4, supra note 9.
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[25]
NAAMECC Statement on COI for IOM supra note 1.
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[26]
ACCME SCS § 2.1, The ACCME defines “‘relevant’ financial relationships” as
financial relationships in any amount occurring within the past 12 months that
create a conflict of interest.
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[27]
ACCME SCS § 2.3, supra note 1.
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[28]
NAAMECC IOM Statement on COI for IOM, supra note 1; NAAMECC Code of Ethics,
supra note 11.
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[29]
NAAMECC Code of Ethics, supra note 11.
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[30]
NAAMECC Statement on COI for IOM, supra note 1.
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[31]
NAAMECC Code of Ethics, supra note 11.
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[32]
PhRMA Code § 4, supra note 9.
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[33]
68 Fed. Reg. 23731-23743, supra note 5.
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[34]
Id.
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[35]
ACCME SCS, supra note 1.
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[36]
Choosing Partners, supra note 1.
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[37]
NC-CME (National Commission for Certification of CME Professionals) creates a
certification exam for CME professionals. See article, Announces the Results of
the First Certification Exam for CME Professionals: Offers Validation of
Competency, Business Wire, July 16, 2008, available at
http://findarticles.com/p/articles/mi_m0EIN/is_/ai_n27915559.
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[38]
ACCME SCS § 1.1, supra note 1.
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[39]
ACCME Policies, supra note 7.
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[40]
FDA Final Guidance, supra note 4.
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[41]
AMA Code, supra note 8. AMA E-9.011, Continuing Medical Education, Faculty:
Guidelines for physicians serving as presenters, moderators, or other faculty at
a CME conference are as follows: (1) Physicians serving as presenters,
moderators, or other faculty at a CME conference should ensure that (a) research
findings and therapeutic recommendations are based on scientifically accurate,
up-to-date information and are presented in a balanced, objective manner.
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[42]
ACCME Policies, supra note 1.
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[43]
NAAMECC IOM Statement for IOM, supra note 1.
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[44]
Overstreet & Ruppenkam, Medical Education: Practical Tips for Mitigating
Risk, Pharmaceutical Executive, (October 2007), available at
http://pharmexec.findpharma.com/pharmexec/article/articleDetail.jsp?id=463109&sk=&date=&
&pageID=2.
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[45]
Paul Mazmanian, Continuing Medical Education and the Physician as a Learner:
Guide to the Evidence, 288 JAMA 9, 1057-1060 (2002) (hereinafter Mazmanian).
Mary Kathryn Robertson, Karl Umble & Ronald Cervero, Impact Studies in
Continuing Education for Health Professions: Update, 23The Journal of Continuing
Education in the Health Processions, 146-156 (2003) (hereinafter Robertson). Marinopoulos SS et al.,
Effectiveness of Continuing Medical Education, Evidence
Report/Technology Assessment 149 (January 2007) (hereinafter Marinopoulos).
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[46]
National Faculty Education Initiative, available at
http://www.nfeinitiative.org/index.cfm?fuseaction=main.press.
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[47]
2 U.S.C. 1601
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[48]
ACCME SCS § 4.2, supra note 1.
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[49]
ACCME SCS § 3.4, supra note 1.
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[50]
Marmanian; Robertson; Marinopoulos, supra note 45.
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[51]
Id.
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[52]
FDA Guidance, supra note 4. Opportunities for Discussion: In the case of a
live presentation, the agency will consider whether there was an opportunity for
meaningful discussion or questioning provided during the program.
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[53]
PhRMA Code § 3, supra note 9. Prohibitions on Entertainment and Recreation
states that, to ensure the appropriate focus on education and informational
exchange and to avoid the appearance of impropriety, companies should not
provide any entertainment or recreational items, such as ticket to the theater
or sporting events, sporting equipment, or leisure or vacation trips to any
healthcare professional who is not a salaried employee of the company.
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[54]
PhRMA Code § 4, supra note 9; AMA Code, supra note 8, Opinion 8.061.
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[55]
PhRMA Code § 4, supra note 9. A company should not provide meals directly at
CME events, except that a CME provider at its own discretion may apply the
financial support provided by a company for a CME event to provide meals for all
participants. AMA Code, Opinion 8.061, Subsidies for hospitality should not be
accepted outside of modest mealsor social events held as a part of a conference
or meeting.
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[56]
Massachusetts’ Department of Public Health (DPH) publicly released proposed
regulations implementing the new pharmaceutical and medical device manufacturer
conduct law at Mass. Gen. L. c. 111N. The new law requires pharmaceutical and
medical device manufacturers to:
- comply with a marketing code of conduct developed by DPH;
- undertake specific compliance activities (training, auditing and
corrective action); and
- disclose payments to providers with a value of $50 or more in connection
with sales and marketing activities. See generally, Memorandum from US Senator
Chuck Grassley to Reporters and Editors on Drug Company Money to Doctors
(February 26, 2008) available at
http://finance.senate.gov/press/Gpress/2008/prg022608.pdf.
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[57]
Physician Payments Sunshine Act of 2007, S.2029, 110th Cong. (2007). See
also, Physician Payments Sunshine Act of 2009, available at
http://aging.senate.gov/letters/ppsabill2009.pdf
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