ASPS offers compliance guidelines for member interaction with industry

by ASPS Staff
04/08/2011 at 1:30PM

Compliance GuidelinesBuilding on the information presented during the Compliance Summit held in December, the ASPS Board of Directors approved guidelines for members' interactions with industry. The comprehensive document, titled "Considerations for Interactions with Industry," aligns with AdvaMed and PhRMA industry guidelines to ensure ethical relationships between physicians and industry.

The document details standards related to the acceptance of gifts, educational products, meals and entertainment from industry; protocols for seeking industry support for educational programs; consulting arrangements; promotional speaking - and the regulations associated with each.

Read the document in its entirety below or download a PDF document.


CONSIDERATIONS FOR INTERACTIONS WITH INDUSTRY

PREAMBLE

The American Society of Plastic Surgeons ("ASPS") is the largest plastic surgery specialty organization in the United States. Founded in 1931, the society is composed of board-certified plastic surgeons who perform both aesthetic and reconstructive surgery ("Members"). The mission of ASPS is to advance quality care to plastic surgery patients by encouraging high standards of training, ethics, physician practice, and research in plastic surgery.

Pharmaceutical, biotechnology, and medical device companies ("Industry") develop, produce, market, or distribute drugs, devices, therapies, or services used to diagnose, treat, monitor, manage, and alleviate health conditions that allow individuals to live longer and healthier lives.

ASPS recognizes that our Members' primary duty is to act in the best interests of patients. Industry can help serve the interests of patients through beneficial collaborations with Members. Ethical relationships between our members and industry are necessary to ensure public confidence in the objectivity of our members which is critical for them to carry out their mission of serving patients. Accordingly, ASPS believes that the interactions of its members within industry must meet high ethical standards.

We adopt these Considerations for Interactions with Industry to reinforce the core principles that help us maintain actual and perceived independence, and ensure ethical relationships between our members and industry. Following these considerations will help to ensure that the interactions of our members with industry will be for the benefit of patients and remain consistent with AdvaMed and PhRMA Industry Guidelines.

These Considerations are primarily focused on the relationships of individual ASPS members rather than on the Society as an organization, but should be read in conjunction with the previously adopted Corporate Guidelines statement which focuses primarily on Society interactions.

I. Basis of Interactions with Industry

Our relationships with Industry are regulated by multiple entities and are intended to benefit patients and to enhance the practice of medicine. Interactions should be focused on receiving information about products, technologies and services that allow us to serve the best interests of our Members' patients.

II. Receiving Items of Value from Industry

Members should not accept items from Industry that do not advance treatment education - even if they are practice-related items of minimal value (such as pens, note pads, mugs, and similar "reminder" items with company or product logos) - because it may foster misperceptions that Industry interactions are not based on medical and scientific matters that further the best interests of our patients. Such items should not be accepted by members of our staff, even if they are accompanied by patient or physician educational materials.

Items intended for the personal benefit of healthcare professionals (such as floral arrangements, artwork, music CDs, or tickets to a sporting event) likewise should not be accepted. Payments in cash or cash equivalents (such as gift certificates) should not be accepted either directly or indirectly, except as compensation for bona fide services (as described in Sections VI and VII). Cash or equivalent payments of any kind create a potential appearance of impropriety or conflict of interest.

It is appropriate to receive a reasonable quantity of product samples for patient use for purposes of product education, evaluation, and demonstration.

III. Receiving Educational Items from Industry

It is appropriate for Members, where permitted by law, to accept from Industry items designed primarily for the education of patients or healthcare professionals if the items are not of substantial value ($100 or less) and do not have value to Members outside of his or her professional responsibilities. For example, an anatomical model for use in an examination room is intended for the education of the patients and is therefore appropriate, whereas a DVD or CD player may have independent value to Members outside of their professional responsibilities, even if it could also be used to provide education to patients, and therefore is not appropriate.

Items designed primarily for the education of patients or healthcare professionals should not be accepted by Members on more than an occasional basis, even if each individual item is appropriate.

IV. Entertainment and Recreation

Industry interactions with Members are professional in nature and are intended to facilitate the exchange of medical or scientific information that will benefit patient care. To ensure the appropriate focus on education and informational exchange and to avoid the appearance of impropriety, Industry should not provide, and Members should not accept, any entertainment or recreational items, such as tickets to the theater or sporting events, sporting equipment, or leisure or vacation trips. Such entertainment or recreational benefits should not be accepted, regardless of (1) the value of the items, (2) whether Industry engages the healthcare professional as a speaker or consultant, or (3) whether the entertainment or recreation is secondary to an educational purpose.

V. Informational Discussions and Meals with Industry

Informational discussions with Industry representatives and others speaking on behalf of a company provide Members with valuable scientific and clinical information about products, technologies, treatments, and services that may lead to improved patient care. In order to facilitate these important scientific and medical discussions, while respecting Members' abilities to manage their schedules and provide patient care, Industry representatives may take the opportunity to present information at mealtimes.

In connection with such presentations or discussions, it is appropriate for occasional meals to be offered by Industry as a business courtesy to Members as well as members of their staff attending presentations, so long as the presentations provide scientific or educational value and the meals (a) are modest, (b) are not part of an entertainment or recreational event, and (c) are provided in a manner conducive to informational communication.

Inclusion of a healthcare professional's spouse or other guest in a meal accompanying an informational presentation made by or on behalf of an Industry representative is not appropriate. Accepting "take-out" meals or meals to be eaten without an Industry representative being present (such as "dine & dash" programs) is not appropriate.

VI. Continuing Medical Education

Continuing medical education (CME) helps physicians and other medical professionals to obtain information and insights that can contribute to the improvement of patient care, and therefore, financial support from Industry is appropriate. Such financial support for CME is intended to support education on a full range of treatment options and not to promote a particular product.

Insofar as the giving of any subsidy directly to a healthcare professional by Industry may be viewed as an inappropriate cash gift, any financial support from Industry should be given to the CME provider (ASPS), which, in turn, can use the money to reduce the overall CME registration fee for all participants. Industry should respect the independent judgment of the ASPS as the CME provider and should follow standards for commercial support established by the Accreditation Council for Continuing Medical Education (ACCME) or other entity that may accredit the CME activity. When companies underwrite CME, responsibility for and control over the selection of content, faculty, educational methods, materials, and venue belongs to the CME provider in accordance with their guidelines. Industry should not be asked to provide any advice or guidance to the CME provider or Members involved in the CME program regarding the content or faculty for a particular CME program funded by Industry.

Our Members should not accept direct financial support from Industry for the costs of travel, lodging, or other personal expenses related to attending CME programs. Similarly, funding should not be accepted by Members to compensate for the time spent by Members attending the CME program. At the same time, it is appropriate for Members serving as faculty at ASPS educational programs to receive honorarium and financial support for travel, lodging, and related expenses from ASPS (as the CME Provider) in accordance with its written policies governing faculty reimbursement. Members serving as ASPS faculty should not accept additional financial support directly from Industry for their role as faculty

VII. Industry Support for ASPS Meetings

Educational conferences or professional meetings of ASPS or its Members can contribute to the improvement of patient care, and therefore, financial support from Industry is appropriate. A conference or meeting is any activity, held at an appropriate location, where (a) the gathering is primarily dedicated, in both time and effort, to promoting objective scientific and educational activities and discourse (one or more educational presentation(s) should be the highlight of the gathering); and (b) the main incentive for bringing attendees together is to further their knowledge on the topic(s) being presented.

Since the giving of any subsidy directly to a healthcare professional by Industry company may be viewed as an inappropriate cash gift, any financial support should be given to the conference's sponsor (ASPS), which, in turn, can use the money to reduce the overall conference registration fee for all attendees. When Industry underwrites medical conferences or meetings other than their own, responsibility for and control over the selection of content, faculty, educational methods, materials, and venue belongs to the organizers of the conferences or meetings in accordance with their guidelines.

Financial support should not be accepted by Members for the costs of travel, lodging, or other personal expenses of Members attending third-party scientific or educational conferences or professional meetings. Similarly, funding should not be accepted by Members to compensate for the time spent by Members attending the conference or meeting.

VIII. Serving as a Consultant for Industry

Consulting arrangements with Industry allow companies to obtain information or advice from medical experts on such topics as the marketplace, products, therapeutic areas, and the needs of patients. Industry uses this advice to inform their efforts to ensure that the products they produce and market are meeting the needs of patients.

It is appropriate for Members who provide advisory services to be offered reasonable compensation for those services and reimbursement for reasonable travel, lodging, and meal expenses incurred as part of providing those services. Any compensation or reimbursement accepted by Members in conjunction with a consulting arrangement should be reasonable and based on fair market value.

Token consulting or advisory arrangements should not be used to justify compensating Members for their time or their travel, lodging, and other out-of-pocket expenses.

While modest meals or receptions may be appropriate during Industry-sponsored meetings with healthcare professional consultants, Members should not participate in recreational or entertainment events in conjunction with these meetings.

It is not appropriate to accept honoraria or travel or lodging expenses for spouses or guests of Members attending Industry-sponsored consultant meetings.

IX. Serving as a Promotional Speaker for Industry

Members participate in Industry-sponsored speaker programs in order to help educate and inform other healthcare professionals about the benefits, risks, and appropriate uses of Industry products.

Any Member engaged by a company to participate in such external promotional programs should be selected based on their medical expertise and reputation, knowledge and experience regarding a particular therapeutic area, and communications skills. Industry and Members should not enter speaking arrangements as inducements or rewards for prescribing or using a particular medicine or product.

Speaker training is an essential activity because the FDA holds speakers accountable for presentations made on behalf of Industry. It is appropriate for Members who participate in programs intended to train speakers for Industry-sponsored speaker programs to be offered reasonable compensation for their time, considering the value of the type of services provided, and to be offered reimbursement for reasonable travel, lodging, and meal expenses. Such compensation and reimbursement should only be accepted by Members when (1) the participants receive extensive training on the company's drug products or other specific topic to be presented and on compliance with FDA regulatory requirements for communications (including the prohibition of the promotion of so-called "off label" uses); (2) this training will result in the participants providing a valuable service to the company; and (3) the participants meet the general criteria for bona fide consulting arrangements.

Any compensation or reimbursement accepted by a Member in conjunction with a speaking arrangement should be reasonable and based on fair market value. Speaker programs may include modest meals offered to attendees and should occur in a venue and manner conducive to informational communication.

While speaker programs offer important educational opportunities to healthcare professionals, they are distinct from CME programs, and Industry and Members serving as speakers should be clear about this distinction. For example, speakers and their materials should clearly identify the company that is sponsoring the presentation, the fact that the speaker is presenting on behalf of the company, and that the speaker is presenting information that is consistent with FDA guidelines.

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