Joint Education and Marketing Programs
There is an update regarding jointly conducted education and marketing programs where the manufacturer promotes its product while a surgeon is highlighting his or her ability to perform the implant procedure. The Code acknowledges the benefit of these programs and provides an outline and principles that help the surgeon and manufacturer stay clear of the Anti-Kickback Statute.
The principles state that the manufacturer and HCP should serve as bona fide partners and costs should be shared equally. There must also be a bona fide and legitimate need for a manufacturer to engage in such programs for its own educational or marketing benefit. The manufactures should establish controls to help ensure that the arrangements do not result in unlawful inducements.
Travels and Lodging
Travel and lodging expense guidelines are consolidated and provide clearer guidelines on when such expenses are permitted and when they are prohibited.
Another section consolidates the guidelines regarding providing meals to HCPs. The Code encourages companies to establish meal policies accounting for costs in more expensive geographic areas.
Implementing the Code
AdvaMed is going to reinforce the code with a two-pronged strategy. The first prong is to work with AdvaMed member companies to ensure they include AdvaMed information on their in-company compliance training. The second is to reach out to medical and surgical societies to offer education for HCP members on the Code.
Companies that adopt the Code are strongly encouraged to submit to AdvaMed an annual certification stating that the company has adopted the Code and has implemented an effective compliance program.
We asked a spokesperson for the American Academy of Orthopaedic Surgeons about the updated Code. The Academy had not yet had a chance to review or comment on the Code.
