AdvaMed's voluntary code of ethics on interactions with healthcare professionals will become effective for manufacturers Sept. 1, following a "grace period" to allow for changes to the HHS Office of Inspector General's pharmaceutical compliance draft guidance.

In the interim, AdvaMed will also send out a FAQ sheet and other educational materials for members to share with employees, agents and distributors. A broader audience, including healthcare providers, will receive a separate information packet.

OIG's draft compliance document, released last October, endorsed the Pharmaceutical Research & Manufacturers of America's voluntary marketing code as a starting-point for future guidance (¹ Also see "Device Firms May Be Held To OIG Pharmaceutical Compliance Standards" - Medtech Insight, 11 November, 2002., p. 13).

Referring to OIG's final guidance, expected by June, Baxter International Associate General Counsel Kristine Rapp noted at the AdvaMed annual meeting March 20 in Aventura, Fla.: "If the OIG...takes a dramatically different turn from what we've seen, [then] we may be coming back together" to reevaluate the guidelines. She referred to the AdvaMed code as "a living document."

Rapp chaired a working group of AdvaMed's legal committee to establish the code. Along with Baxter International Senior VP-General Counsel Thomas Sabatino and Reed Smith LLP Partner Elizabeth Carder-Thompson, Rapp presented the code to AdvaMed members during a session of the trade group's annual meeting. AdvaMed's board of directors unanimously approved the document on the same day.

Development of the code began last June and incorporated elements of the federal anti-kickback statute and PhRMA and American Medical Association codes. The initiative updates 1993 AdvaMed guidelines (² Also see "Device Marketing Code Follows Pharma Effort; Dollens Is HLC Chair Jan. 15" - Medtech Insight, 9 December, 2002., p. 3).

The new code contains a preamble acknowledging the role of "ongoing instruction, education, training, service and technical support" in medical device promotion. "This is really the area in which the device industry differs from the drug industry," Rapp commented. The preamble explains "why this industry is unique and distinct from other industries."

Borrowing language from the federal anti-kickback statute, AdvaMed's code defines healthcare professionals as "individuals or entities that purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe members' products in the U.S."

Areas governed by the code include: member-sponsored training and education; supporting third-party educational conferences; sales and promotional meetings; arrangements with consultants; gifts; reimbursement support programs; and grants and other charitable donations.

In the code, AdvaMed allows members to "occasionally" provide "modest" gifts to healthcare professionals, "but only if the gifts benefit patients or serve a genuine educational function." The term "modest," independent of a monetary amount, derives from PhRMA's code.

Also adhering to the PhRMA standard, the code specifies that gifts should not cost more than $100; however, AdvaMed's version allows for textbooks or anatomical models exceeding that sum.

On March 19, drafters of the code decided that "members may occasionally give healthcare professionals branded promotional items of minimal value - such as pens, note pads and mugs - related to the healthcare professional's work or for the benefit of patients," according to the document.

Under the provision, items such as golf balls may not be gifted to physicians, Rapp explained. "The answer is no," she said. "When the PhRMA code came out, one of the things that stuck in our mind was the provision about gifts and whether golf balls in particular could be given.... And when we first started dealing with this section, we figured it's probably a trivial point."

"It isn't trivial, and it became a very meaningful part of the dialogue that we had with members in [a conference] call last week," she observed.

Regarding member-sponsored product training and education, the code explains that "such programs often occur at centralized locations" necessitating out-of-town travel, "and may extend more than one day."

Consequently, the guidelines authorize "reasonable" travel and lodging expenses for healthcare professional attendees. "Guests" or spouses, meanwhile, may not enjoy such benefits unless "incremental costs to members are nominal."

"This is the grazing spouse and the sleeping spouse exception," Carder-Thompson said. "If the spouse or the guest comes to the meeting and wants to share the hotel room, and there's no additional cost to that, that's fine under this." The exception accords with AMA guidelines, revised in 2002. "PhRMA does not have a section that addresses this," she noted.

Regarding healthcare professional travel costs for member-sponsored product training, Carder-Thompson discouraged paying a per diem rate for the time the physician is away from his or her practice.

"I would not do that," the attorney opined. "I think it's different if there's a consultant: you can work with the consultant, and you're paying the consultant fair market value for the consultant services." Similarly, "I would limit it to 'modest' travel, too, which is to say not first class."

Addressing sales and promotional meetings, the code allows for "reasonable travel costs of attendees," but stipulates that "it is not appropriate to pay for meals, travel or other hospitality of healthcare guests," or spouses. The code notes that "often, these meetings occur close to the healthcare professional's place of business." Paying for providers' guests would turn a sales and promotional meeting into a "social rather than a business event," Carder-Thompson reflected.

AdvaMed's provision for consultant fees carries five criteria, including the requirement that "member consulting arrangements should be written, signed by the parties and specify all services to be provided." Confidentiality language alone does not qualify as a written agreement, Carder-Thompson stressed.

The guidelines also limit members' reimbursement support programs to "identifying appropriate coverage, coding or billing of member products, or procedures using those products, or to encouraging the economically efficient delivery of member products."

"Members should refrain from providing general practice management advice of material value to healthcare professionals without charging fair market value," the code states.

The five-page document does not cover meetings related to product development, intellectual property, and certain interactions with clinical investigators. Guidant Cardiac Rhythm Management Group Chief Compliance Officer Kathleen Lundberg and Abbott Diagnostics Reimbursement & Health Policy Director Virginia Tobiason helped draft the code; in all, 17 firms participated, and J&J's Dennis Longstreet chaired a special committee to review the document.

Golf Ball Gifts, Spouse Travel Funds Prohibited By AdvaMed Ethics Code

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