In the wake of increased federal investigation into wrong-doing between physicians and drug manufacturers, the world’s largest medical technology trade association has updated its ethical code to help medical technology companies and physicians identify appropriate hospitality, gifts, charitable contributions, and reimbursement practices. AdvaMed, the Advanced Medical Technology Association, which represents more than 1,100 medical technology firms and their subsidiaries that produce 90 percent of the medical products sold annually in the United States, has updated its Code of Ethics on Interactions with Health Care Professionals. The new Code sets clear expectations for ethical interactions between health care providers and companies that produce medical devices, diagnostic products and medical information systems. The code was prompted, in part, by recent criminal and civil investigations that often focused on doctors who allegedly received lavish entertainment and trips from the pharmaceutical industry in exchange for their prescribing decisions. The government also has alleged that grants and donations have been used as bribes, and that the pharmaceutical industry has used improper means to promote off-label uses of drugs. In fact, according to the departments of Health & Human Service’s and Justice’s 2002 Annual Report, 3,448 providers and suppliers were excluded from the Medicare and Medicaid programs, and 480 defendants were convicted of health care fraud in that year alone. Importantly, AdvaMed’s code distinguishes legitimate interactions from potential abuses that can undermine the private health care system and technology innovation. Health care professionals partner with the medical technology industry in critically vital ways: Physicians often provide valuable expertise in how a product should be designed, and they may participate in gathering federally required safety and efficacy data. Companies routinely train physicians in the safe and effective use of complex medical technologies, and senior physicians may go on to train other students. Physicians may also identify worthy and legitimate charitable and educational entities that could benefit from developing technology. AdvaMed’s revised code seeks to maintain these vital, unique interactions between health care professionals and the medical technology industry. The new AdvaMed code shares some, but not all, provisions of the PhRMA Code (released in 2002 from the Pharmaceutical Research and Manufacturers of America). AdvaMed’s code identifies seven categories of typical company/health care professional interactions and provides guidance with respect to each:
1. Member-Sponsored Product Training and Education 2. Supporting Third Party Educational Conferences 3. Sales and Promotional Meetings 4. Arrangements with Consultants 5. Gifts 6. Provision of Reimbursement and Other Economic Information 7. Grants and Other Charitable DonationsThe AdvaMed code instructs firms that interactions not covered in one of these seven categories should be guided by the following principle: AdvaMed member companies will encourage ethical business practices and socially responsible industry conduct and will not use any unlawful inducement to sell, lease, recommend or arrange for the sale, lease or prescription of, their products. This new Code will impact medical technology firms and health care professionals in several ways. Although the full text of the AdvaMed code should be consulted (preferably with legal counsel), some of the key areas addressed are:
Hospitality, Meals and Receptions, and Spouses: Industry-sponsored hospitality is limited to modest meals and receptions for health care professionals attending sales and promotional meetings, third-party conferences, and member-sponsored product training and education. Travel or hospitality for spouses and guests overall is prohibited, although travel for health care professionals attending these meetings is allowed within certain guidelines. Third Party Conferences: Only health care providers in training can receive scholarships that are underwritten by grants from medical technology companies. The training institution or the conference sponsor -not the medical technology company must select the scholarship recipients. Medical technology companies may not select or pay for conference speakers. Gifts: Medical technology firms may provide modest, occasional gifts to health care professionals so long as they benefit the patient or serve a genuine educational function and have a fair market value of less than $100 (textbooks and anatomical models excepted). Research and other Grants: Companies may make donations for a charitable purpose, such as supporting genuine independent medical research for the advancement of medical science or education, indigent care, patient education, public education or the sponsorship of events where proceeds are intended for charitable purposes. Consulting Services: It is appropriate to reasonably compensate health care professionals for performing bona fide consulting services, as defined by the AdvaMed code. For example, the agreements must be in writing, provide for fair market value compensation, and entered into only where a legitimate need and purpose is identified in advance. Selection of consultants should be based solely on the consultant’s qualifications and expertise to address the identified purpose.You can find the entire AdvaMed Code, which becomes effective January 1, 2004, as well as additional information, at: www.advamed.org/publicdocs/coe.html Included in these materials is the pocket brochure Understanding A New Code of Ethics, designed specifically to help physicians navigate the various code provisions. Note: Although Cath Lab Digest is the first to publish this article, it may be published elsewhere as it remains the property of AdvaMed.