OGC-5.01 - Addendum (FAQS)
May 15, 2006
AMA clarifying addendum: General questions and answers
(a) Do the guidelines apply only to pharmaceutical, device, and equipment manufacturers?
"Industry" includes all "proprietary health-related entities that might create a conflict of interest."
Any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value. Accordingly, textbooks, modest meals and other gifts are appropriate if they serve a genuine educational function. Cash payments should not be accepted. The use of drug samples for personal or family use is permissible as long as these practices do not interfere with patient access to drug samples. It would not be acceptable for non-retired physicians to request free pharmaceuticals for personal use or for use by family members.
(a) May physicians accept gram stain test kits, stethoscopes or other diagnostic equipment?
Diagnostic equipment primarily benefits the patient. Hence, such gifts are permissible as long as they are not of substantial value. In considering the value of the gift, the relevant measure is not the cost to the company of providing the gift. Rather, the relevant measure is the cost to the physician if the physician purchased the gift on the open market.
(b) May companies invite physicians to a dinner with a speaker and donate $100 to a charity or medical school on behalf of the physician?
There are positive aspects to the proposal. The donations would be used for a worthy cause, and the physicians would receive important information about patient care. There is a direct personal benefit to the physician as well, however. An organization that is important to the physician - and one that the physician might have ordinarily felt obligated to make a contribution to - receives financial support as a result of the physician's decision to attend the meeting. On balance, physicians should make their own judgment about these inducements. If the charity is predetermined without the physician's input, there would seem to be little problem with the arrangement.
(c) May contributions to a professional society's general fund be accepted from industry?
The guidelines are designed to deal with gifts from industry which affect, or could appear to affect, the judgment of individual practicing physicians. In general, a professional society should make its own judgment about gifts from industry to the society itself.
(d) When companies invite physicians to a dinner with a speaker, what are the relevant guidelines?
First, the dinner must be a modest meal. Second, the guideline does allow gifts that primarily benefit patients and that are not of substantial value. Accordingly, textbooks and other gifts that primarily benefit patient care and that have a value to the physician in the general range of $100 are permissible. When educational meetings occur in conjunction with a social event such as a meal, the educational component must have independent value, such as a presentation by an authoritative speaker other than a sales representative of the company. Also, the meal should be a modest one similar to what a physician routinely might have when dining at his or her own expense. In an office or hospital encounter with a company representative, it is permissible to accept a meal of nominal value, such as a sandwich or snack.
(e) May physicians accept vouchers that reimburse them for uncompensated care they have provided?
No. Such a voucher would result directly in increased income for the physician.
(f) May physicians accumulate "points" by attending several educational or promotional meetings and then choose a gift from a catalogue of education options?
This guideline permits gifts only if they are not of substantial value. If accumulation of points would result in physicians receiving a substantial gift by combining insubstantial gifts over a relatively short period of time, it would be inappropriate.
(g) May physicians accept gift certificates for educational materials when attending promotional or educational events?
The Council views gift certificates as a grey area which is not per se prohibited by the guidelines. Medical text books are explicitly approved as gifts under the guidelines. A gift certificate for educational materials, i.e., for the selection by the physician from an exclusively medical text book catalogue, would not seem to be materially different. The issue is whether the gift certificate gives the recipient such control as to make the certificate similar to cash. As with charitable donations, pre-selection by the sponsor removes any question. It is up to the individual physician to make the final judgment.
(h) May physicians accept drug samples or other free pharmaceuticals for personal use or use by family members?
The Council's guidelines permit personal or family use of free pharmaceuticals (i) in emergencies and other cases where the immediate use of a drug is indicated, (ii) on a trial basis to assess tolerance and (iii) for the treatment of acute conditions requiring short courses of inexpensive therapy, as permitted by Opinion E-8.19: Self-Treatment or Treatment of Immediate Family Members. It would not be acceptable for physicians to accept free pharmaceuticals for the long-term treatment of chronic conditions.
(i) May companies invite physicians to a dinner with a speaker and offer them a large number of gifts from which to choose one?
In general, the greater the freedom of choice given to the physician, the more the offer seems like cash. A large number of gifts presented to physicians who attend a dinner would therefore be inappropriate.
There is no precise way of deciding an appropriate upper limit on the amount of choice that is acceptable. However, it is important that a specific limit be chosen to ensure clarity in the guidelines. A limit of eight has been chosen because it permits flexibility but prevents undue freedom of choice. Each of the choices must have a value to the physicians of no more than $100.
(j) May physicians charge for their time with industry representatives or otherwise receive material compensation for participation in a detail visit?
Guideline 1 states that gifts in the form of cash payments should not be accepted. Also, Guideline 6 makes clear that, in the context of the industry-physician relationship, only physicians who provide genuine services may receive reasonable compensation. When considering the time a physician spends with an industry representative, it is the representative who offers a service, namely the presentation of information. The physician is a beneficiary of the service. Overall, these guidelines do not view that physicians should be compensated for the time spent participating in educational activities, nor for time spent receiving detail information from an industry representative.
Individual gifts of minimal value are permissible as long as the gifts are related to the physician's work (e.g., pens and notepads).
(a) May physicians, individually or through their practice group, accept electronic equipment, such as hand held devices or computers, intended to facilitate their ability to receive detail information electronically?
Although Guideline 2 recognizes that gifts related to a physician' s practice may be appropriate, it also makes clear that these gifts must remain of minimal value. It is not appropriate for physicians to accept expensive hardware or software equipment even though one purpose only may pertain to industry-related activities of a modest value.
The Council on Ethical and Judicial Affairs defines a legitimate "conference" or "meeting" as 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. An appropriate disclosure of financial support or conflict of interest should be made.
Subsidies to underwrite the costs of continuing medical education conferences or professional meetings can contribute to the improvement of patient care and therefore are permissible. Since the giving of a subsidy directly to a physician by a company's sales representative may create a relationship which could influence the use of the company's products, any subsidy should be accepted by the conference's sponsor who in turn can use the money to reduce the conference's registration fee. Payments to defray the costs of a conference should not be accepted directly from the company by the physicians attending the conference.
( a) Are conference subsidies from the educational division of a company covered by the guidelines?
Yes. When the Council says "any subsidy," it would not matter whether the subsidy comes from the sales division, the educational division or some other section of the company.
(b) May a company or its intermediary send physicians a check or voucher to offset the registration fee at a specific conference or a conference of the physician's choice?
Physicians should not directly accept checks or certificates which would be used to offset registration fees. The gift of a reduced registration should be made across the board and through the accredited sponsor.
Subsidies from industry should not be accepted directly or indirectly to pay for the costs of travel, lodging or other personal expenses of physicians attending conferences or meetings, nor should subsidies be accepted to compensate for the physicians' time. Subsidies for hospitality should not be accepted outside of modest meals or social events held as a part of a conference or meeting. It is appropriate for faculty at conferences or meetings to accept reasonable honoraria and to accept reimbursement for reasonable travel, lodging and meal expenses. It is also appropriate for consultants who provide genuine services to receive reasonable compensation and to accept reimbursement for reasonable travel, lodging and meal expenses. Token consulting or advisory arrangements cannot be used to justify the compensation of physicians for their time or their travel, lodging, and other out-of-pocket expenses.
( a) If a company invites physicians to visit its facilities for a tour or to become educated about one of its products, may the company pay travel expenses and honoraria?
This question has come up in the context of a rehabilitation facility that wants physicians to know of its existence so that they may refer their patients to the facility. It has also come up in the context of surgical device or equipment manufacturers who want physicians to become familiar with their products.
In general, travel expenses should not be reimbursed, nor should honoraria be paid for the visiting physician's time since the presentations are analogous to a pharmaceutical company's educational or promotional meetings. The Council recognizes that medical devices, equipment and other technologies may require, in some circumstances, special evaluation or training in proper usage which can not practicably be provided except on site. Medical specialties are in a better position to advise physicians regarding the appropriateness of reimbursement with regard to these trips. In cases where the company insists on such visits as a means of protection from liability for improper usage, physicians and their specialties should make the judgment. In no case would honoraria be appropriate and any travel expenses should be only those strictly necessary.
(b) If the company invites physicians to visit its facilities for review and comment on a product, to discuss their independent research projects or to explore the potential for collaborative research, may the company pay travel expenses and an honorarium?
If the physician is providing genuine services, reasonable compensation for time and travel expenses can be given. However, token advisory or consulting arrangements cannot be used to justify compensation.
(c) May a company hold a sweepstakes for physicians in which five entrants receive a trip to the Virgin Islands or airfare to the medical meeting of their choice?
No. The use of a sweepstakes or raffle to deliver a gift does not affect the permissibility of the gift. Since the sweepstakes is not open to the public, the guidelines apply in full force.
(d) If a company convenes a group of physicians to recruit clinical investigators or convenes a group of clinical investigators for a meeting to discuss their results, may the company pay for their travel expenses?
Expenses may be paid if the meetings serve a genuine research purpose. One guide to their propriety would be whether the NIH conducts similar meetings when it sponsors multi-center clinical trials. When travel subsidies are acceptable, the guidelines emphasize that they be used to pay only for "reasonable" expenses. The reasonableness of expenses would depend on a number of considerations. For example, meetings are likely to be problematic if overseas locations are used for exclusively domestic investigators. It would be inappropriate to pay for recreation or entertainment beyond the kind of modest hospitality described in this guideline.
(e) How can a physician tell whether there is a "genuine research purpose?"
A number of factors can be considered. Signs that a genuine research purpose exists include the facts that there are (1) a valid study protocol, (2) recruitment of physicians with appropriate qualifications or expertise, and (3) recruitment of an appropriate number of physicians in light of the number of study participants needed for statistical evaluation.
(f) May a company compensate physicians for their time and travel expenses when they participate in focus groups?
Yes. As long as the focus groups serve a genuine and exclusive research purpose and are not used for promotional purposes, physicians may be compensated for time and travel expenses. The number of physicians used in a particular focus group or in multiple focus groups should be an appropriate size to accomplish the research purpose, but no larger.
(g) Do the restrictions on travel, lodging and meals apply to educational programs run by medical schools, professional societies or other accredited organizations which are funded by industry, or do they apply only to programs developed and run by industry?
The restrictions apply to all conferences or meetings which are funded by industry. The Council drew no distinction on the basis of the organizer of the conference or meeting. The Council felt that the gift of travel expenses is too substantial even when the conference is run by a non-industry sponsor. (Industry includes all "proprietary health-related entities that might create a conflict of interest.")
(h) May company funds be used for travel expenses and honoraria for bona fide faculty at educational meetings?
This guideline draws a distinction between attendees and faculty. As was stated, "[i]t is appropriate for faculty at conferences or meetings to accept reasonable honoraria and to accept reimbursement for reasonable travel, lodging, and meal expenses."
Companies need to be mindful of the guidelines of the Accreditation Council on Continuing Medical Education. According to those guidelines, "[f]unds from a commercial source should be in the form of an educational grant made payable to the CME sponsor for the support of programming."
) May travel expenses be reimbursed for physicians presenting a poster or a "free paper" at a scientific conference?
Reimbursement may be accepted only by bona fide faculty. The presentation of a poster or a free paper does not by itself qualify a person as a member of the conference faculty for purposes of these guidelines.
(j) When a professional association schedules a long-range planning meeting, is it appropriate for industry to subsidize the travel expenses of the meeting participants?
The guidelines are designed to deal with gifts from industry which affect, or could appear to affect the judgment of individual practicing physicians. In general, a professional society should make its own judgment about gifts from industry to the society itself.
(k) May continuing medical education conferences be held in the Bahamas , Europe or South America ?
There are no restrictions on the location of conferences as long as the attendees are paying their own travel expenses.
(l) May travel expenses be accepted by physicians who are being trained as speakers or faculty for educational conferences and meetings?
In general, no. If a physician is presenting as an independent expert at a CME event both the training and its reimbursement raise questions about independence. In addition, the training is a gift because the physician's role is generally more analogous to that of an attendee than a participant. Speaker training sessions can be distinguished from meetings (See 5b) with leading researchers, sponsored by a company, designed primarily for an exchange of information about important developments or treatments, including the sponsor's own research, for which reimbursement for travel may be appropriate.
m) What kinds of social events during conferences and meetings may be subsidized by industry?
Social events should satisfy three criteria. First, the value of the event to the physician should be modest. Second, the event should facilitate discussion among attendees and/or discussion between attendees and faculty. Third, the educational part of the conference should account for a substantial majority of the total time accounted for by the educational activities and social events together. Events that would be viewed (as in the succeeding question) as lavish or expensive should be avoided. But modest social activities that are not elaborate or unusual are permissible, e.g., inexpensive boat rides, barbecues, entertainment that draws on the local performers. In general, any such events which are a part of the conference program should be open to all registrants.
(n) May a company rent an expensive entertainment complex for a evening during a medical conference and invite the physicians attending the conference?
No. The guidelines permit only modest hospitality.
o) If physicians attending a conference engage in interactive exchange, may their travel expenses be paid by industry?
No. Mere interactive exchange would not constitute genuine consulting services.
(p) If a company schedules a conference and provides meals for the attendees that fall within the guidelines, may the company also pay for the costs of the meals for spouses?
If a meal falls within the guidelines, then the physician's spouse may be included.
(q) May companies donate funds to sponsor a professional society's charity golf tournament?
Yes. But it is sensible if physicians who play in the tournament make some contribution themselves to the event.
(r) If a company invites a group of consultants to a meeting and a consultant brings a spouse, may the company pay the costs of lodging or meals of the spouse? Does it matter if the meal is part of the program for the consultants?
Since the costs of having a spouse share a hotel room or join a modest meal are nominal, it is permissible for the company to subsidize those costs. However, if the total subsidies become substantial, then they become unacceptable.
Scholarship or other special funds to permit medical students, residents, and fellows to attend carefully selected educational conferences may be permissible as long as the selection of students, residents, or fellows who will receive the funds is made by the academic or training institution. Carefully selected educational conferences are generally defined as the major educational, scientific or policy-making meetings of national, regional or specialty medical associations.
(a) When a company subsidizes the travel expenses of residents to an appropriately selected conference, may the residents receive the subsidy directly from the company?
Funds for scholarships or other special funds should be given to the academic departments or the accredited sponsor of the conference. The disbursement of funds can then be made by the departments or the conference sponsor.
(b) What is meant by "carefully selected educational conferences?"
The intent of Guideline 6 is to ensure that financial hardship does not prevent students, residents and fellows from attending major educational conferences. For example, we did not want to deny cardiology fellows the opportunity to attend the annual scientific meeting of the American College of Cardiology or orthopedic surgery residents the opportunity to attend the annual scientific meeting of the American Academy of Orthopedic Surgeons. However, it was not the intent of the guideline to permit reimbursement of travel expenses in other circumstances, such as when conferences or symposia are designed specifically for students, residents or fellows.
Accordingly, "carefully selected educational conferences" should be interpreted as follows: funds may be used for the reasonable travel and lodging expenses of students, residents and fellows to attend the major educational, scientific or policymaking meetings of national, regional or specialty medical associations.
The Council recognizes that there may be some exceptional conferences for all physicians or even for just students, residents, or fellows that do not fall within this definition of carefully selected educational conferences but that meet the spirit of Guideline 6. Accordingly, the Council will consider proposals for travel and lodging subsidies for such conferences on a case-by-case basis and grant approval to those that meet the spirit of the guidelines.
No gifts should be accepted if there are strings attached. For example, physicians should not accept gifts if they are given in relation to the physician's prescribing practices. In addition, when companies underwrite medical conferences or lectures other than their own, responsibility for and control over the selection of content, faculty, educational methods, and materials should belong to the organizers of the conferences or lectures.
(a) May companies send their top prescribers, purchasers, or referrers on cruises?
No. There can be no link between prescribing or referring patterns and gifts. In addition, travel expenses, including cruises, are not permissible.
(b) May the funding company itself develop the complete educational program that is sponsored by an accredited continuing medical education sponsor?
No. The funding company may finance the development of the program through its grant to the sponsor, but the accredited sponsor must have responsibility and control over the content and faculty of conferences, meetings, or lectures. Neither the funding company nor an independent consulting firm should develop the complete educational program for approval by the accredited sponsor.
(c) How much input may a funding company have in the development of a conference, meeting, or lectures?
The guidelines of the Accreditation Council on Continuing Medical Education on commercial support of continuing medical education address this question.