On January 9, 2019, the Advanced Medical Technology Association (AdvaMed) announced that its Board of Directors had approved an updated version of its Code of Ethics on Interactions with U.S. Health Care Professionals (HCPs).
Key changes include: new sections guiding education and marketing programs, communication on safe and effective use of medical technology, and on providing technical support; expanded provisions on support for third-party educational and other conferences; clarified and expanded definitions of HCPs and “medical technology”; and revisions to provide additional clarity, definition and explanation of existing Code provisions.
The principles for consulting arrangements set forth in the existing Code are maintained in the updated Code. However, the updated Code provides additional detail with respect to establishing a legitimate need for services, noting that a legitimate need arises when a company requires the services of an HCP to achieve a specific objective. The updated Code also states that rewarding an HCP for business or referrals is not a legitimate need for a consulting arrangement. Further, the updated Code provides an explanation for how manufacturers can establish fair market value compensation rates for consulting services.
The principles for providing grants, sponsorships, and donations remain largely unchanged in the updated Code, but AdvaMed did consolidate its principles on those funding arrangements into one section. The updated Code also includes a checklist for reviewing educational grant requests and expands and clarifies requirements for providing independent research grants and charitable donations. There are also new principles that address satellite symposia.
Jointly Conducted Education & Marketing
In the updated Code, there is a new section on jointly conducted education and marketing programs. Such a jointly conducted program would be an educational program during which the manufacturer promotes its surgical implant while a surgeon is highlighting his or her ability to perform the implant procedure. The Code acknowledges the benefit to these types of programs and provides an outline and principles that manufacturers should apply to ensure that the program does not unduly benefit the HCP in a manner that may violate the Anti-Kickback Statute.
Principles stated in the Code include: that the manufacturer and HCP should serve as bona fide partners, and contributions and costs should be shared fairly and equitably between the parties; that there must be a bona fide, legitimate need for a manufacturer to engage in such programs for its own educational or marketing benefit; and that a manufacturer should establish controls to help ensure that decisions to engage in these arrangements are not made as unlawful inducements.
The updated Code consolidates the guidelines regarding covering HCPs’ travel and lodging expenses into one section and provides clearer guidelines on when travel and lodging expenses are permitted (e.g., consulting services, company-conducted product training, speaking on the company’s behalf, plant tours and product demonstrations) and when they are prohibited (e.g., general educational program, company meeting without an objective, to attend a third-party educational program). The updated Code also provides principles for evaluating appropriate venues for meetings.
Another section consolidated in the updated Code is that of guidelines regarding providing meals to HCPs. Of note, the Code encourages companies to establish meal policies and specifically contemplates that such an established meal policy may allow for variation to account for more expensive geographic areas.
Effective Date and Comments
The revisions will be effective January 1, 2020, to ensure ample time for stakeholder implementation.
“The updates reflect evolving legal standards, care delivery models and best practices over the last decade – since AdvaMed’s last Code update in 2008 – and are designed to ensure the Code’s continued effectiveness as a premier foundational document for ethics and compliance across the medtech industry,” said AdvaMed President and CEO Scott Whitaker. “These revisions, which also enhance usability and reader-friendliness, reflect our industry’s continued commitment to ethics, integrity and transparency.”
Interview with Matt Wetzel
We had the privilege of speaking with Matt Wetzel, Vice President and Deputy General Counsel, about the changes to the Code. Wetzel pointed out what he believes to be the most important changes, including adding better descriptions throughout the Code to make it more readable, accessible, and useable for field sales representatives.
He also discussed implementation, noting that there is a two-pronged educational effort to reinforce the code. The first prong is working with member companies to ensure they include AdvaMed information on their in-company compliance training. The second prong is reaching out to medical and surgical societies to offer education for HCP members on a basic understanding of the Code, with the aim to ensure ethical interaction between manufacturer representatives and HCPs.
Since we are in the era of Sunshine, AdvaMed understands the importance of both HCPs and manufacturers understanding their role in compliant interactions. To that end, AdvaMed is willing to send spokespersons to annual meetings in an attempt to educate main points of the Code and to offer a better understanding.
The updated Code can be found here.
An overview of the changes to the Code can be found here.