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New Medical Code Impacts Interactions with Pharmaceutical, Medical Device and Other Health Care Entities

On April 21, 2010, the Council of Medical Specialty Societies (“CMSS“), a not-for-profit association of 32 member Societies[i] created to “provide an independent forum for the discussion by medical specialists of issues of national interest and mutual concern,” announced[ii] the release of the CMSS Code for Interactions with Companies(“Code“).[iii] This voluntary Code was developed by the CMSS Task Force on Professionalism and Conflicts of Interest and adopted by CMSS to “reinforce the core principles that help us maintain actual and perceived independence” and “to ensure that a Society’s transactions with Companies will be for the benefit of patients and members and for the improvement of care in our respective specialty fields.”[iv]

The Code is applicable to interactions with “Companies,”[v] which are defined generally as “for-profit entities that develop, produce, market or distribute drugs, devices, services or therapies used to diagnose, treat, monitor, manage, and alleviate health conditions.”[vi]With regard to this definition, the Code references the Advanced Medical Technology Association Code of Ethics on Interactions with Health Care Professionals (“AdvaMed Code“)[vii] and the definition of “commercial interest” promulgated by the Accreditation Council for Continuing Medical Education (“ACCME“).[viii]

Generally, the Code sets forth 10 “Principles” in four key areas: (i) conflicts of interest, (ii) financial disclosures, (iii) independent program development and (iv) independent leadership. These Principles may be changed by the CMSS Board of Directors only. The Code also provides “Annotations”—additional explanations and examples of the Principles—that reflect CMSS’ current interpretation of the Principles. Annotations may be updated periodically by CMSS.

As of the date that CMSS announced the release of the Code, 13 of the 32 member Societies voluntarily adopted the Code, including, by way of example, the American Academy of Family Physicians and the American College of Cardiology.[ix] Each Society that chooses to adopt the Code is encouraged to also adopt and implement policies and procedures tailored to satisfy the Society’s individual needs. These policies and procedures may be more stringent than the Code.

This Alert provides an overview of the Code’s Principles and certain relevant Annotations. It then discusses some key considerations for Companies in their interactions and activities with the Societies that adopt the Code and the members of those Societies.

OVERVIEW OF THE CODE

Independence

The Code states that Societies should develop all educational activities, scientific programs, products, services and advocacy positions independent of Company influence. Societies also should separate programmatic decision-making and seeking support from Companies through Educational Grants, Corporate Sponsorships, Charitable Contributions and Research Grants. Societies should identify a high-level group responsible for overseeing these interactions with Companies.

Additionally, the Code requires Societies to use written agreements with Companies that receive support through Educational Grants, Corporate Sponsorships, Charitable Contributions, Business Transactions or Research Grants. According to the Annotation, the written agreement should articulate the purpose of the funds, state the amount of support and describe the separate roles of the Company. It is the intent of CMSS to develop template agreements for use by Societies; however, Societies also may develop their own agreements.

The Code also states that Key Society Leaders may not have a Direct Financial Relationship with Companies during their term of service. The Annotation states that Key Society Leaders may provide uncompensated service or accept research support if the funds are paid to the institution where the research is conducted rather than the individual, provided that any such support is disclosed to the Society and to the public.

Transparency

Societies must adopt written disclosure policies for Key Society Leaders, Board members, committee members and other relevant individuals. These policies will be used to manage conflicts of interest, which must be disclosed at least annually and at the time of a material change.

Further, Societies must make the following information available to members and the public: (i) conflicts of interest policies and/or forms, (ii) financial and uncompensated relationships of Key Society Leaders and Board members with Companies[x] and (iii) support provided to the Society from Companies.[xi]

Accepting Charitable Contributions

Societies must use Charitable Contributions in a manner that is aligned with the Society’s strategic plan and mission and compliant with applicable tax rules and legal standards. Although it is appropriate for Companies to place reasonable restrictions on the purposes for which the Charitable Contributions may be used, Companies may not influence the Society’s programs or advocacy positions. Societies must adopt policies for consistent and appropriate recognition of Companies.

Accepting Corporate Sponsorships

Societies only may accept Corporate Sponsorships that are aligned with the Society’s strategic plan and mission and must make reasonable efforts to seek multiple Corporate Sponsors. Societies may not put a Company’s name or logo on any item that the Company is not permitted to give directly to health care professionals under relevant ethical standards, including the AdvaMed Code and the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals.[xii]

If a Company provides a Corporate Sponsorship for a data registry, the Company may not participate in the direct management of the registry. According to the Annotation, a Company that provides a Corporate Sponsorship should not: (i) be involved in decisions to sell, disclose or publish registry data; (ii) serve on registry steering groups; or (iii) receive special access to the registry data.

Society Meetings

The Principle related to Society Meetings is divided into the following four subcategories:

1. Educational Grants and Society CME

Societies must comply with the ACCME Standards for Commercial Support (“ACCME Standards“).[xiii] Specifically, Societies must: (i) adopt policies and procedures designed to identify and manage conflicts of interest in CME programs supported by Companies; (ii) retain control over the use of Educational Grants; (iii) implement safeguards designed to ensure that educational programs are non-promotional and free of commercial influence and bias; and (iv) select the objectives, content, faculty and format of educational activities. Societies may not seek support for product-specific topics and will make reasonable efforts to receive support from multiple sources for each Society CME program.

Societies may not solicit suggestions from Companies regarding program topics, speakers or content. Speakers may not use Company-controlled presentation materials or slides with Company logos. Societies also will require Speakers to give a balanced view of therapeutic options and encourage Speakers to use generic names rather than product trade names.

 

2. CME-Accredited Satellite Symposia[xiv]

Societies must require Satellite CME Symposia to undergo an application and selection process and comply with ACCME Standards. Satellite CME Symposia must be distinguished clearly from Society CME. Key Society Leaders may not participate in Satellite CME Symposia in any role other than attendee without honoraria or reimbursement.

The Annotation states that in order to minimize the potential for bias in Satellite CME Symposia, Societies may consider the following “best practices”: (i) requiring presentations to be evidence-based, (ii) requiring peer review of slide presentations in advance, (iii) prohibiting presenters who disclose unmanageable conflicts from making practice recommendations and (iv) requiring presentations to be monitored for bias.

3. Non-CME Informational/Educational Programs

Non-CME Informational/Educational Programs must be distinguished clearly from Society CME programs.

4. Exhibits

Societies must adopt written policies related to the nature of the exhibits and the conduct of exhibitors. The Annotation states that these policies should include, among other items, information related to exhibit decor, size and activities to ensure that the tone of the exhibit hall is professional in nature.

In addition, exhibitor giveaways must be limited to “educational” items that are “modest in value.” Exhibit booths should not be placed in the path to Society CME sessions, if possible. Key Society Leaders may not participate in Company events in exhibit space.

Awarding of Research Grants

Societies must appoint independent committees to select recipients of Research Grants based on peer review of grant applications. Companies may not select or influence the selection of recipients. Companies also may not receive intellectual property rights or royalties arising out of research funded by a Research Grant, or control or influence manuscripts arising from such research.

If a Society receives funding from a Company to support its own research, the Society must act independently in the selection of a research topic and the conduct of the research. Such support from the Company must be disclosed by the Society.

Clinical Practice Guidelines

Societies may not receive direct support from Companies for the development of Clinical Practices Guidelines or Guideline Updates (collectively, “Guidelines“). In addition, Societies may not discuss the development of the Guidelines with Companies, accept unpublished data from Companies or permit Companies to review draft Guidelines. All Guidelines must be based on scientific evidence and subject to multiple levels of review, including, but not limited to, a rigorous peer-review process, review by at least one Society body beyond the Guideline development panel and independent editorial review by the journal or other publication where the Guidelines are first published.

Societies must follow a transparent Guideline development process that is free of Company influence. For all Guidelines published after the Code is adopted, Societies must publish a description of the Guideline development process in the Society’s journal or on the Society’s website.

Panel members and contributors must disclose financial or other relevant relationships that may constitute a conflict of interest and update the disclosure throughout the Guideline development process. Societies will publish disclosures from panel members adjacent to each Guideline and identify abstentions from voting. Societies should recommend that panel members decline offers from any Company to speak about the Guidelines on behalf of the Company for a reasonable period after publication.

Societies also must develop procedures for addressing conflicts of interest. At a minimum, the panel chair must be free of conflicts of interest and remain as such for at least one year after publication of the Guidelines. In addition, the Society must require that a majority of panel members also be free of conflicts of interest.

Companies may not provide support for the initial printing, publication or distribution of the Guidelines. Societies may accept Company support for further distribution, translation or repurposing of the Guidelines.

Society Journals

Society Journals must maintain editorial independence from the Society and Advertisers. Society Journals also must require all authors, editors and reviewers to disclose financial and other relationships with Companies. The editor-in-chief has ultimate responsibility for determining whether an editor or reviewer is disqualified from reviewing a manuscript. Further, Society Journals must adopt policies prohibiting the submission of “ghost-written” manuscripts prepared by or on behalf of a Company.

Standards for Advertising

Societies must adopt written policies that set standards for Advertising. The Annotation states that that Advertising should be easily distinguishable from editorial content and should not be designed to look like a scientific article. In addition, Advertising may not be placed adjacent to articles or editorial content discussing the Company or Company’s product.

Standards for Licensing

Societies must adopt written standards for licensing related to the misuse, unintended use or modification of licensed materials and inappropriate use of Society trademarks.

KEY CONSIDERATIONS

There are numerous codes and other industry guidelines that impact Companies, directly or indirectly. The CMSS Code is one such code that, although not directly applicable to Companies, creates additional challenges when interacting with certain business partners. Companies should consider the following:

□ Coordination with Other Current Codes and Industry Guidelines. The CMSS Code may be inconsistent with, or provide more limitations than, other current codes and industry guidelines. In addition, each Society is expected to adopt its own policies and procedures to implement the Code, which may be more stringent than the Code’s requirements. Companies should consider these differences when developing compliance policies, procedures and processes and when training employees that interact with Societies that, or Society members who, have adopted the Code. Specifically, Companies should consider how to educate representatives regarding the existence of relevant codes and industry guidelines, provide direction to representatives regarding how to handle conflicting codes and otherwise ensure compliance with all relevant codes and industry guidelines.

□ Consistency with Regulatory Requirements. The CMSS Code limits a Company’s role in a data registry sponsored by the Company. Such limits may conflict with a Company’s regulatory requirements for the registry. A Company supporting a data registry should define clearly in a written agreement its role and responsibilities related to the data registry to ensure that its applicable regulatory requirements can be satisfied.

□ Use of Society Agreements. It is common industry practice for a Company that provides support, including CME Grants, Charitable Contributions and Research Grants, to require recipients to enter into a written agreement with the Company. The Code requires the same for Societies accepting such support from Companies, but suggests that Societies use their own agreement or the template agreement developed by CMSS. The Code is unclear whether Societies may use Company agreements to satisfy this Principle. Companies should be aware of this Code requirement and consider how the Company will respond if the need arises.

□ Public Disclosure of Funding. Companies should note that Societies are required to make public certain information regarding support received from Companies. Companies should ensure that such posted information is consistent with information reported under applicable federal and state marketing and disclosure laws[xv] and other disclosure requirements.[xvi] One area of particular note is related to support for Research Grants. Currently, depending on the applicable federal or state law, information related to Research Grants is excluded from reporting or disclosure is delayed to protect the sensitive nature of this information. The Code requires disclosure of this information and currently does not provide for a delay in disclosure. Companies should coordinate with CMSS as it develops the template that Societies will use to disclose this information.

* * *

This Client Alert was authored by Wendy C. Goldstein and Sarah K. Giesting. For additional information about the issues discussed in this Client Alert, please contact one of the authors or the EpsteinBeckerGreen attorney who regularly handles your legal matters.

 

 

The EpsteinBeckerGreen Client Alert is published by EBG’s Health Care and Life Sciences practice to inform health care organizations of all types about significant new legal developments.

 

Lynn Shapiro Snyder, Esq.

EDITOR

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ENDNOTES:

[i] CMSS’ member Societies are the following: American Academy of Allergy, Asthma & Immunology (AAAAI); American Academy of Dermatology (AAD); American Academy of Family Physicians (AAFP); American Academy of Neurology (AAN); American Academy of Ophthalmology (AAO); American Academy of Otolaryngology – Head and Neck Surgery (AAOHNS); American Academy of Pediatrics (AAP); American Academy of Physical Medicine & Rehabilitation (AAPMR); American College of Cardiology (ACC); American College of Emergency Physicians (ACEP); American College of Medical Genetics (ACMG); American College of Obstetricians & Gynecologists (ACOG); American College of Occupational and Environmental Medicine (ACOEM); American College of Physicians (ACP); American College of Preventive Medicine (ACPM); American College of Radiology (ACR); American College of Surgeons (ACS); American Geriatrics Society (AGS); American Medical Informatics Association (AMIA); American Psychiatric Association (APA); American Society for Clinical Pathology (ASCP); American Society for Reproductive Medicine (ASRM); American Society for Radiation Oncology (ASTRO); American Society of Clinical Oncology (ASCO); American Society of Colon and Rectal Surgeons (ASCRS); American Society of Plastic Surgeons (ASPS); American Urological Association (AUA); Society of Critical Care Medicine (SCCM); Society of Neurological Surgeons (SNS); Society of Nuclear Medicine (SNM); Society of Thoracic Surgeons (STS).

[iv] Id.

[v] Terms capitalized throughout this Alert are terms used by and/or defined in the Code. Definitions, in whole or part, have been included in this Alert where necessary and appropriate. Refer to the Code for the complete list of definitions.

[vi] The Code states that it is not applicable to interactions with non-profit entities, entities outside of the health care sector or entities through which a physician provides clinical services directly to a patient. However, member Societies may adopt a broader definition.

[x] The Annotation states that Societies should disclose employment, consulting or advisory arrangements, stock ownership, honoraria, research funding paid to an individual’s institution or practice, expert testimony and gifts.

[xi] At a minimum, Societies must disclose the following: Educational Grants, Corporate Sponsorships, Charitable Contributions and Research Grants. The Annotation states that the disclosure should include the name of the Company, category of support, time period of support and dollar amount or range.

[xiv] The Code defines “Satellite CME Symposium” as “a Company-supported CME program held as an adjunct to a Society meeting where CME credit for the Symposium is provided by a third party CME provider, and for which the Society receives a fee.” This definition does not include programs held adjunct to a Society meeting but which are not Company-supported, are not CME accredited or for which the Society does not receive a fee.

[xv] Currently, seven states – California, Maine, Massachusetts, Minnesota, Nevada, Vermont and West Virginia – as well as the District of Columbia have state marketing and disclosures laws relevant to pharmaceutical, biotechnology and/or medical device companies and their interactions with health care professionals.

[xvi] By way of example, disclosure requirements may arise from contractual obligations in settlement agreements with federal and/or state authorities. See, e.g., Lilly and Company Corporate Integrity Agreement (1/14/09); Cephalon, Inc. Corporate Integrity Agreement (9/29/08).