The Advanced Medical Technology Association (AdvaMed), the largest trade association of producers of medical devices, diagnostic products and health information systems,  announced on December 18, 2008, a major update of its voluntary “Code of Ethics on Interactions with Health Care Professionals.” The revised Code further clarifies and distinguishes between appropriate and inappropriate activity between health care professionals and representatives of AdvaMed member companies. It also establishes a new certification mechanism to foster compliance with the Code. The revised AdvaMed Code takes effect on July 1, 2009.

The revised AdvaMed Code is similar to the recently-updated Pharmaceutical Research and Manufacturers of America's Code on Interactions with Health Care Professionals (the PhRMA Code).  However, the AdvaMed Code provides additional guidance on some types of interactions with healthcare professionals that are more relevant to, or prevalent in, the medical device industry, such as reimbursement support and providing free products for evaluation or demonstration purposes.

Several areas in the revised Code are either not addressed in the current AdvaMed Code or are tightened and clarified, including:

• An explicit prohibition on providing any entertainment or recreation (such as golf, vacations, or tickets to sporting events or to the theater) to health care professionals, regardless of value and regardless whether the health care professional is a consultant to the company.
• An explicit prohibition on gifts of any type, including all non-educational branded promotional items (such as coffee mugs and pens), regardless of value.
• An expanded section on consulting arrangements that includes guidelines for royalty arrangements between companies and health care professionals.
• A new section addressing “evaluation and demonstration products” that sets forth guidelines under which companies may provide products intended to educate both health care professionals and patients on new or improved medical technologies.
• An expanded section addressing the provision of reimbursement, coverage and health economics information to health care providers.
• A clarified section concerning acceptable grants for research, which states that companies should not provide "unrestricted" research grants.

While the AdvaMed Code continues to be a voluntary industry code, AdvaMed "strongly encourages" companies to adopt the Code and implement an effective program to foster compliance with it, and “strongly encourages” individual companies to submit annual certifications to AdvaMed that the company has adopted the revised Code and implemented an effective compliance program. AdvaMed will publish the list of certifying companies on its website.

AdvaMed's decision to update the Code reflects the increased scrutiny on the medical device industry coming from Congress, state legislatures, government investigations and the general public.

Developing and implementing compliance rules is a continual effort that demands periodic reassessment.  If you have questions about the updated AdvaMed Code  or general compliance issues relating to your business, please contact one of our attorneys listed on this page or your regular Taft legal advisor.