On January 9, 2019, the Advanced Medical Technology Association (AdvaMed) announced updates to its “Code of Ethics on Interactions with Health Care Professionals” (Code). The Code was last updated in 2008; the newest updates will become effective on January 1, 2020.
The Code includes new sections on jointly conducted education and marketing, communications about the safe and effective use of medical technology, and communications related to providing technical support. Other topics that were previously covered in multiple sections have been consolidated into more comprehensive sections on company programs, third-party programs, travel, and meals. Enhancements and clarifying language have been added to the definitions, the section on consulting, and the section on products provided for demonstration and evaluation. Additional detail about some of these updates is highlighted below.
In the Consulting section, the Code clarifies that a legitimate need for consulting services arises when a company requires the services of a health care professional (HCP) to achieve a specific objective; designing or creating an arrangement to generate business or reward referrals are not legitimate needs. The Code also includes criteria a company should consider when seeking to establish fair market value for goods and services (e.g., the HCP’s specialty, years and type of experience, geographic location, practice setting, and type of services performed).
The Third-Party Programs section now includes a checklist companies can use to evaluate requests for educational program support. This section also clarifies that a company cannot pass the benefits of program sponsorship on to an HCP but can host satellite symposia and can pay for the travel costs of HCPs serving as faculty members at the satellite symposia.
The new section on Jointly Conducted Education and Marketing Programs explains that these programs are designed to highlight both a medical technology and a HCP’s ability to diagnose or treat medical conditions. The Code acknowledges that these types of programs have benefit, but cautions that the company and the HCP must serve as bona fide partners. To establish a bona fide partnership, the arrangement should be documented in a written agreement and contributions and costs should be shared equitably between the company and HCP.
The Travel section provides clearer guidance on when a company may pay for travel and lodging (e.g., consulting services, attending at a company-conducted training or education program, speaking on the company’s behalf) and when such payments are prohibited (e.g., attending general company meetings or third-party programs). The Code also includes guidance for evaluating appropriate meeting venues.
The new section on Communicating for the Safe and Effective Use of Medical Technology recognizes that communications about on- and off-label uses of a device are critical to a HCP’s ability to his or her medical judgment. This section encourages companies to develop policies and controls for the dissemination of truthful and non-misleading information.
The final new section sets forth principles for Company Representatives Providing Technical Support in the Clinical Setting. For example, the company representatives should be transparent that they are acting on behalf of the company and should not interfere with a HCP’s independent clinical decision making. Additionally, the company’s technical support should not eliminate an expense that the HCP would otherwise incur while providing patient care.
Although the Code is a voluntary standard, certain states (e.g., Connecticut and Nevada) require device manufacturers to adopt compliance programs consistent with the Code. Manufacturers will want to review the latest updates and make adjustments to their compliance programs as necessary.