The final version of the AdvaMed Code of Ethics on Interactions with Healthcare Professionals — a voluntary code for members of Washington, D.C.-based Advanced Medical Technology Association, a medical device company association — went through some changes since it was released in draft form this spring. The voluntary code will become effective January 1, 2004.

“We did tighten it up,” says Blair Childs, executive vice president of AdvaMed. “We had a candid discussion with the Office of Inspector General of Health and Human Services. They gave us some useful input, and the board decided to look at some of the issues again. We thought some of the points they made were valid, and we adjusted the code accordingly.”

This spring, the OIG released its own compliance program guidance for pharmaceutical manufacturers to help them comply with federal anti-kickback laws. The guidance contained a footnote that explained that while it was directed at pharma, some of the same precepts apply to medical device and nutritional product manufacturers as well. The AdvaMed code provides guidelines for areas that have come under government scrutiny: product training and education for healthcare professionals, sales and promotional meetings, consultant arrangements, and gifts. It also addresses medical association meeting funding.

“The challenge was to make the code clear, to avoid having different companies interpret things differently,” says Childs. “This is challenging for us, because unlike the pharmaceutical industry, which is relatively homogeneous, our industry includes everything from implantable devices to MRIs.”

Elizabeth Carder-Thompson, partner, Reed Smith LLP in Washington, D.C., and one of the code's authors, adds, “The final code is a good document, and I hope it will be embraced by the industry. While the device industry definitely has some differences from the pharmaceutical industry, the application of fraud and abuse laws is pretty much the same.”

What Got Tighter?

“The changes that were made overall link the AdvaMed Code more closely to the PhRMA Code,” says Carder-Thompson. For example, in the section covering product training and education, the draft said that device companies may provide attendees with modest meals and hospitality in connection with such programs, and that it might be appropriate for guests to participate in group hospitality provided that costs were nominal. The final version specifies that hospitality and meals may be provided only for healthcare professionals — the part about guests has been deleted.

Similarly, in the section about supporting third-party educational conferences, the revised code says that device firms may provide meals and receptions for all healthcare professional attendees; while the draft said that meals and hospitality could be provided for any program attendees. In addition, the final Code includes a new FAQ regarding making charitable contributions to a not-for-profit institution to pay for the registration or seminar fees and travel expenses for one or more of its affiliated healthcare professionals to attend a third-party educational conference. The short answer is “no,” but members could provide funding to “a third-party conference that the conference sponsor could apply to defray reasonable travel expenses of faculty selected by the sponsor, or to reduce registration or seminar fees for all attendees,” the sponsor being the conference organizer, not the company.

It also is no longer acceptable to provide meals and “hospitality” — which could be defined to include things such as golf — at sales and promotional meetings. “Occasional hospitality” now is defined as only modest meals and receptions for healthcare professional attendees.

The Code's Impact

“I think it's going to change behavior by industry, no question,” says Childs. “We represent the companies that produce about 90 percent of the medical device products sold in this country, so it's going to impact the vast majority of the industry.” If they take the voluntary code to heart, that is, and Carder-Thompson thinks they will.

“It doesn't technically go into effect until January 1, but the clients I'm dealing with are already taking it very seriously,” says Carder-Thompson. “I think we'd all rather see the money go into education and research instead of logoed golf balls.”

Irwin Kuperberg, president of the Institute for Advanced Medical Education in Rye, N.Y., also thinks the AdvaMed Code will benefit CME providers in the same way the PhRMA Code does: “It asks them to shift from activities that are mostly big sales incentives for the customers toward more legitimate CME activities. These codes, along with the OIG guidance, mean “no more boondoggles, no more excessive spending for speakers and advisory boards, no more providing huge incentives and kickbacks to doctors,” he says. “It gets these companies to rethink what they're doing, and redo it from a CME perspective. It creates opportunity for CME providers.”

How much of an opportunity? Kuperberg says, “The pressure is on pharma and these device companies, and they rely on us to relieve that pressure. One person at an academic CME office told me his business has tripled since all the pressure started.”

For a copy of the AdvaMed code, visit www.advamed.org.