April 2004 Bulletin

AAOS reinforces ethics guidelines

Industry - physician relationships must be appropriate

By Jeanne L. DelSignore, MD and Richard N. Peterson, JD

In recent years, there has been extensive publicity on the relationship between the health care industry and individual physicians. The AAOS and the American Medical Association (AMA) each have provided guidance on what the appropriate relationship should be, and the U.S. Government, in the Office of the Inspector General of the U.S. Depart- ment of Health and Human Services and the Food and Drug Administration, has also offered its views. The Pharmaceutical Research and Manufacturers of America (PhRMA) released its “Code on Interactions with Health Care Professionals” in 2002 and most recently, the Advanced Medical Technology Association (AdvaMed) released its own “Code of Ethics on Interactions with Health Care Professionals.”

Each of these statements indicates a strong concern for appropriate interactions between health care companies and physicians. All were developed with knowledge that this relationship has sometimes been abused by both the health care companies and the physicians involved. In addition to citing the other important documents, this article will focus on the current AAOS statement and the AdvaMed Code of Ethics on Interactions, which became effective January 1, 2004.

AAOS Opinion on Ethics and Professionalism
The AAOS Opinion on Ethics and Professionalism on “Gifts and the Orthopaedic Surgeon's Relationship with Industry” was substantially revised in December 2001 after several years of deliberations by the AAOS Ethics Committee, the Board of Councilors and the Board of Directors. It is found in its entirety on the AAOS Web site.

The AAOS Opinion addresses the question of under what, if any, circumstances it is appropriate for orthopaedic surgeons to accept gifts or other financial support from industry, including pharmaceutical, biomaterial or device manufacturers. The Opinion includes the following statement:

The Academy believes that is acceptable for industry to provide financial and other support to orthopaedic surgeons if such support has significant educational value and has the purpose of improving patient care. All dealings between orthopaedic surgeons and industry should benefit the patient and be able to withstand public scrutiny.

The AAOS Opinion provides eight clear guidelines interpreting this statement to help orthopaedic surgeons avoid the acceptance of inappropriate gifts or other financial support. Among these guidelines are:

The AAOS Ethics Committee continues to monitor the environment and will recommend modifications to the AAOS Opinion as the situation warrants.

AdvaMed Code of Ethics on Interactions
AdvaMed represents more than 1,100 innovators and manufacturers of medical devices, diagnostic products and medical information systems. AdvaMed issued its voluntary “Code of Ethics on Interactions with Health Care Professionals” in September 2003, and it became effective on January 1, 2004. It can be found in its entirety at www.advamed.org/code_of_ethics.htm.

Upon the release of the Code, AdvaMed president Pamela G. Bailey stated: “We are keeping pace with the most current thinking on manufacturers' interactions with health care professionals who help develop and use lifesaving, life-improving medical innovations. This voluntary Code provides companies with information to facilitate ethical interactions with their partners in the health care community.”

Further, an AdvaMed letter to health care professionals dated February 9, 2004, noted that “[w]hile AdvaMed members know that the vast majority of technology firms and health care professionals behave responsibly and ethically, the transgressions of a few have drawn increased scrutiny and attention, first to the pharmaceutical industry and now—potentially—to the relationships we maintain with you and your colleagues. In fact, according to the Departments of Health and Human Services' and Justice's 2002 Annual Reports, 3,448 providers and suppliers were excluded from the Medicare and Medicaid programs, and 480 defendants were convicted in that year alone.” This letter is signed by the presidents of six major orthopaedic technology firms, who pledged their companies' commitment to complying with AdvaMed's Code of Ethics on Interactions with Health Care Professionals.

The AdvaMed Code discusses several types of interactions between health care companies and health care professionals (including physicians) that advance medical science and/or improve patient care. They include:

The AdvaMed Code also recognizes that there may be many interactions between health care companies and health care professionals other than selling, leasing and recommending the sale or prescription of products that are not specifically discussed in the Code. The Code highlights that all interactions between health care companies and health care professionals, whether or not specifically discussed in the Code, should follow “ethical business practices and socially responsible industry conduct and shall not use any unlawful inducement in order to sell, lease, recommend, or arrange for the sale, lease or prescription of ...products.”

Education support
The AdvaMed Code draws a distinction between product training and education provided by AdvaMed member companies and AdvaMed member's support of third-party educational conferences, such as those provided by the AAOS and other specialty societies.

For AdvaMed member-sponsored education, companies may pay for reasonable travel and modest lodging costs incurred by the attending health care professional as well as modest meals and receptions in connection with these programs. Under the Code, it is not appropriate for the AdvaMed Company to pay for the meals, hospitality, travel or other expenses of the guests of the health care professional or of any other person who does not have a bona fide professional interest in the information being shared at the meeting.

The AdvaMed Code provides that member companies may support third-party medical educational conferences in several ways. This support may be in the form of:

The AdvaMed Code is silent on whether member companies may pay for the reasonable travel, meals or hospitality expenses of health care professionals (not faculty) attending a third-party educational conference.

Gifts and technologies
The AdvaMed Code specifically addresses gifts to health care professionals, permitting such “gifts only if the gifts benefit patients or serve a genuine education function. Other than the gift of medical textbooks or anatomical models used for educational purposes, any gift from a[n AdvaMed] member should have a fair market value of less than $100.” The AdvaMed Code also discusses in some detail the appropriate interactions between health care companies and health care professionals in sales and promotional meetings, the use of health care professionals as bona fide consultants, and the appropriate reimbursement for education about new medical technologies.

Summary
The increasing interest in interactions between health care companies and health care professionals, including physicians, has resulted in a proliferation of voluntary codes and guidelines governing these relationships. AdvaMed developed the most recent of these voluntary codes.

The AAOS Ethics Committee commends AdvaMed on the development of this important code and is pleased that it generally follows the major provisions of the AAOS Opinion on Ethics and Professionalism on “Gifts and the Orthopaedic Surgeon's Relationship with Industry.”

Although the AAOS statement and the AdvaMed statement differ in some respects, both acknowledge that the relationship between health care companies and health care professionals is critically important and may have significant educational value and improve patient care.

The AAOS Committee on Ethics continually reviews and updates the Opinions on Ethics and Professionalism, reflecting changes in the milieu and offering guidelines for AAOS members to follow.

We strongly encourage orthopaedic surgeons, health care company representatives and others involved in medical education to read and understand the AAOS Opinion, the AdvaMed Code and similar documents involving the complex and potentially challenging and rewarding relationships between health care companies and health care professionals.

Resources:

  1. AdvaMed Code of Ethics on Interactions with Health Care Professionals: www.advamed.org/code_of_ethics.htm
  2. American Academy of Orthopaedic Surgeons Opinion on Ethics and Professionalism
  3. American Medical Association Ethical Guidelines for Gifts to Physicians from Industry: www.ama-assn.org/go/ethicalgifts.
  4. Pharmaceutical Research and Manufacturers Association (PhRMA): www.PhRMa.org
  5. U.S Department of Health and Human Services, Department of Inspector General - 68 Fed. Reg. 23731 (May 5, 2003): www.oig.hhs.gov/authorities/frnotices.html
  6. U.S. Food and Drug Administration Guidance for Industry: www.fda.gov/cder/guidance/isse.pdf
Jeanne L. DelSignore, MD, is chair of the AAOS Ethics Committee; Richard N. Peterson, JD, is the AAOS General Counsel.


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