The American Society of Plastic Surgeons (“ASPS”) recently adopted a voluntary set of standards to help guide its individual members in dealing with pharmaceutical, biotechnology, and medical device companies. The guidelines cover topics ranging from: (1) acceptance of gifts, (2) educational products, (3) meals and entertainment, (4) educational programming, (5) consulting arrangement; and (6) promotional speaking. The guidelines are consistent with voluntary rules already adopted by Advamed (a trade association representing medical device manufacturers, makers of medical equipment, medical software, etc. as well as those voluntarily adopted by the pharmaceutical industry. Highlights from the new guidelines are set for below and may be found in their complete form at http://www.psnextra.org/Articles/Compliance-Guidelines.html.
1. Receiving Items of Value from Industry Representatives
In order to avoid the appearance of impropriety, the guidelines state that “[m]embers should refrain from accepting items that do not advance treatment or education.” The ‘prohibition’ extends to practice-related items of minimal value including pens, note pads, mugs, and other “reminder” items with company or product logos (and should not even be accepted by staff members). Similarly, items intended for the personal use (such as floral arrangements, artwork, music CDs or tickets to sporting events should also be rejected). In the same vein, the guidelines prohibit payments in cash (or cash equivalents such as gift certificates) unless they constitute compensation for bona fide services. It is, however, still appropriate to accept a reasonable quantity of product samples for patient use, education, evaluation and/or demonstration.
2. Entertainment and Recreation
Very simply, ASPS members should not accept entertainment or recreational items, such as tickets to the theater or sporting events or vacation trips regardless of the value of the items and/or whether it is offered in conjunction with speaking engagements or consulting duties.
3. Informational Discussions and Meals with Industry
In connection with the presentation of scientific or clinical information, members may accept occasional meals as a “business courtesy” 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 delivering relevant information.
Accepting meals to be eaten without an industry representative being present (such as “dine & dash” programs) are not appropriate nor, is he a physician or staff member’s spouse is not appropriate.
4. Continuing Medical Education
Corporate financial support or sponsorship for continuing medical education (“CME”) intended to support education on a full range of treatment options, as opposed to promoting particular products is acceptable. However, industry financial support should be given directly to the ASPS. It may then use the money to reduce overall CME registration fees for all participants. Concomitantly, 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, ASPS members should not accept industry funding to compensate for the time spent attending the CME program. However, it is acceptable for members serving as faculty at ASPS educational programs to receive honorarium or financial support for travel, lodging, and related expenses. Such honorarium should come directly from ASPS; members should not accept additional financial support directly from industry for such activities.
5. Serving as a Consultant for Industry
While it is appropriate for ASPS members providing advisory services to be offered reasonable compensation for their legitimate services (and reimbursement for reasonable travel, lodging, meals, etc.) Payment should be reasonable and based upon fair market value and should not be extended to spouses or family members. Likewise, recreational or entertainment events offered in conjunction with these meetings are not honoraria and should not be viewed as such.
6. Serving as a Promotional Speaker for Industry.
Any ASPS member hired to participate in promotional programs should not undertake such activities for the purpose of prescribing or using a particular medicine or product in his or her practice. However, it is appropriate for Members who participate in programs intended to train speakers for Industry-sponsored speaker programs to receive be compensation for their time, travel, lodging, and meals. Again, such payment should reflect fair market value. Moreover, 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; (2) topics covered include compliance with FDA regulatory requirements including the prohibition of the promotion “off label” uses) and (3) the participants meet the general criteria for bona fide consulting arrangements.
Doug Nadjari is a partner at Ruskin Moscou Faltischek where he is a member of the firm’s Health Law Regulatory Department and White-Collar Crime & Investigations Practice Group. Mr. Nadjari’s work primarily involves matters of physician discipline, hospital staff proceedings, managed care disputes as well as the defense of physicians and corporations in criminal, administrative and commercial disputes. He is a member of the Nassau County Bar Association, New York State Bar Association, New York State Association of Criminal Defense Attorneys and the New York State Medical Defense Bar Association.