Advamed Adopts Revised Code Of Ethics On Interactions With Health Care Professionals

AdvaMed member companies "are strongly encouraged" but

not required to adopt the revised Code of Ethics on Interactions

with Health Care Professionals and implement an effective program

to establish and maintain compliance.

On December 18, 2008, the Board of Directors of the Advanced

Medical Technology Association (AdvaMed), the trade association for

the medical technology industry, adopted a revised Code of Ethics on Interactions with Health Care

Professionals (Code) The revised Code takes formal effect July

1, 2009. AdvaMed member companies "are strongly

encouraged" but not required to adopt the revised Code and

implement an effective program to establish and maintain compliance

with the revised Code.

The revised Code updates existing standards and establishes new

standards for interactions with health care professionals addressed

in the current Code. It is generally more restrictive than the

current Code and prohibits interactions that were previously

permissible. This is similar to the approach reflected in the

revised Code on Interactions with Healthcare Professionals (PhRMA

Code) that was recently adopted by the Pharmaceutical Research and

Manufacturers Association of America, the trade association for

pharmaceutical and biotechnology companies. (The revised PhRMA Code

is available here and described in more detail in

McDermott's White Paper "

PhRMA Revises Code on Interactions with Healthcare

Professionals,".)

Following is a discussion of the significant changes made by

AdvaMed in the revised Code.

Definition of Health Care Professional

While the revised Code's definition of health care

professionals (HCPs) is substantially the same as the one in the

current Code, AdvaMed revised the definition to clarify that the

Code applies to interactions with anyone "involved in the

provision of health care services and/or items to patients,"

not only physicians and other practitioners. This revision reflects

the scope of the federal Anti-Kickback Statute, which applies

broadly to any individual or organization in a position to

purchase, order or recommend items or services reimbursable by

Medicare and other federal health care programs. (The PhRMA Code

does not include a definition of health care professional.)

As a result, the revised Code applies to a broader scope of

interactions than other industry codes and state laws. For

instance, the Pharmaceutical and Medical Device Manufacturer Code

of Conduct regulations proposed by the Massachusetts Department of

Health under that state's Pharmaceutical and Medical Device

Disclosure Law only apply to interactions with physicians and other

health care practitioners that prescribe or order drugs or devices,

as well as their practice entities, employees, officers, agents and

contractors, and not to others in a position to purchase, order or

recommend medical technology, pharmaceuticals or biotechnology. The

Massachusetts law is described in more detail in McDermott's

White Paper "

Massachusetts Enacts Pharmaceutical and Medical Device Disclosure

Law," and the proposed regulations are described in more

detail in McDermott's White Paper "

Massachusetts Proposed Regulations for Pharmaceutical and Medical

Device Disclosure Law Compliance".

Limitations on Gifts

The current Code permits modest gifts to HCPs if the gifts

benefit patients (e.g., educational brochures) or serve a

genuine educational function, or are branded promotional items of

minimal value related to the HCP's work or for the benefit of

patients. The revised Code still permits companies to provide items

that benefit patients or serve a genuine educational function,

provided that the value is less than $100 (except for textbooks or

anatomical models used for...