Source: https://namec-assn.org/code-of-conduct
Timestamp: 2020-01-21 06:06:45
Document Index: 293052208

Matched Legal Cases: ['§ 119400', '§ 1', '§ 4', '§ 1', '§ 2', '§ 2', '§ 4', '§ 3', '§ 3', '§ 4']

NAMEC - Code of Conduct
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.
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]
Providers and supporters are strongly encouraged to comply, as appropriate, with the seven elements of an effective compliance program as defined by the OIG:
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),
responding promptly to detected problems and undertaking corrective action.[13]
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),
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,
focus of the activity,
relationship between provider and supporting company,
provider involvement in sales or marketing,
provider’s demonstrated failure to meet standards,
audience selection,
opportunities for discussion,
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.
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:
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 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.
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.
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.
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.
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
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).
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)
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)
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
Firewalls (See previous firewall section)
Historical compliance with industry standards
Previous violation(s)/probation(s)
Terms of Corporate Integrity Agreement (if any)
Handling irregularities and complaints
Collective staff competencies
Scientific (eg, PhD, MD, RN, MSN, PharmD, etc.) and educational (eg, EdD, MEd) credentials
Licensure and professional certification (eg, CCMEP)[37]
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
identification of CME needs,
selection of all persons and organizations that will be in a position to control the content of the CME,
evaluation of the activity.[38]
Supporters can have no role in recommendation or selection of faculty, or in content review prior to an activity.
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.
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.
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]
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.
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.
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:
Office of the Inspector General (OIG; available at http://oig.hhs.gov/exclusions/index.asp).
General Services Administration (GSA; Excluded Parties List System (EPLS) available at http://www.epls.gov).
Food and Drug Administration (FDA; available at http://www.fda.gov/ICECI/EnforcementActions/FDADebarmentList/default.htm).
National Institutes of Health (NIH; available at https://ned.nih.gov/search/).
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.
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]
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.
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).
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.
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).
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.
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
AHME: Association for Hospital Medical Education
CGA: Call for Grant Application
CCMEP: Certified CME Professionals
CPG: Compliance Program Guidance
GSA: US General Service Administration
MECC: Medical Education and Communication Companies
NAAMECC: North American Association of Medical Education and Communication Companies, Inc.
SACME: The Society for Academic Continuing Medical Education
SCS: Standards
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).
42 U.S.C. § Sec. 3729-3733
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).
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
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.
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).
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).
PhRMA Code on Interactions with Healthcare Professionals (Revised 2008), available at http://www.phrma.org/files/PhRMA Marketing Code 2008.pdf (PhRMA Code).
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).
NAAMEC Code of Ethics, available HERE (hereinafter NAAMECC Code of Ethics).
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:
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.
ACCME SCS § 1.2, supra note 1.
NAAMECC Code of Ethics, supra note 11.
PhRMA Code § 4, supra note 9.
ACCME SCS § 1.1, supra note 1.
FDA Guidance, supra note 4.
68 Fed. Reg. 23731-23743, supra note 5.
ACCME Policies, supra note 7.
NAAMECC Statement on COI for IOM supra note 1.
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.
ACCME SCS § 2.3, supra note 1.
NAAMECC IOM Statement on COI for IOM, supra note 1; NAAMECC Code of Ethics, supra note 11.
ACCME SCS, supra note 1.
Choosing Partners, supra note 1.
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.
FDA Final Guidance, supra note 4.
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.
ACCME Policies, supra note 1.
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.
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).
National Faculty Education Initiative, available at http://www.nfeinitiative.org/index.cfm?fuseaction=main.press.
ACCME SCS § 4.2, supra note 1.
ACCME SCS § 3.4, supra note 1.
Marmanian; Robertson; Marinopoulos, supra note 45.
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.
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.
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.
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;
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.
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