On January 9, 2019, the Advanced Medical Technology Association (AdvaMed) released an updated version of its "Code of Ethics on Interactions with U.S. Health Care Professionals" (HCPs) (the Code),1 which will take effect on January 1, 2020. AdvaMed President and CEO Scott Whitaker noted that "[t]he 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."2
While the Code is not legally binding, it incorporates many key principles of U.S. healthcare laws and regulations that apply to medical technology companies' interactions with HCPs, including the federal Anti-Kickback Statute, and serves as a valuable baseline guide to help companies comply with the key legal requirements.
Reflecting advances in medical technology and the growing digital health industry, the definition of "medical technology" has been enhanced to include "[d]igital technology and software platforms that assist in monitoring, diagnosing, and treating patients" and "[n]on-invasive reagents, instrumentation, and/or software to aid in the diagnosis and treatment of patients; among other technology."3 The new Code also expressly includes combination products that include a medical technology component.4 The geographic reach of the Code has been broadened to "appl[y] to all company interactions with U.S. healthcare professionals, whether occurring inside or outside the United States (such as at a conference or other event)."5
The new Code sets forth six "cornerstone values"—innovation, education, integrity, respect, responsibility, and transparency.6 Three new sections have been added to address the following principles:
- Jointly Conducted Education and Marketing Programs:7
- There must be a bona fide, legitimate need for the company to engage in the activity for its own educational or marketing benefit.
- Companies should establish controls to help ensure that decisions to engage in these arrangements are not made as an unlawful inducement and require HCPs in these arrangements to comply with company guidelines on providing information related to a product's labeling and guidelines for furnishing appropriate health economics information, among other controls.
- Jointly conducted education and marketing programs should be balanced and promote both the company and its medical technologies, and the HCP and the range of services offered for the diagnosis and treatment of related medical conditions.
- The company and the HCP should serve as bona fide partners in the program and should make equitable contributions towards the activity and costs.
- The arrangement should be documented in a written agreement that describes the purpose of the arrangement and the roles, responsibilities, and contributions of each party, including payment of costs.
- Communicating for the Safe and Effective Use of Medical Technology:8
- Company responses that contain information regarding unapproved or uncleared uses should be provided by authorized personnel.
- Company communications must be truthful and non-misleading.
- Information related to unapproved or uncleared uses should be identified as such.
- Company Representatives Providing Technical Support in the Clinical Setting:9
- Company representatives should enter and be present in the clinical setting only at the request of and under the supervision of a HCP.
- Company representatives should be transparent that they are acting on behalf of the company in a technical support capacity.
- Company representatives should not interfere with a HCP's independent clinical decision making.
- Company representatives should comply with applicable hospital or facility policies and requirements, including patient privacy and credentialing requirements.
- A company's technical support should not eliminate an overhead or other expense that the HCP should otherwise incur while providing patient care.
The new Code also includes guidance to companies who provide products to customers on a consignment basis. This guidance is reflected in the "Demonstration, Evaluation, and Consigned Products" section of the new Code and recommends that companies set forth the terms of consignment in a written agreement and encourages companies to implement appropriate product controls, such as taking periodic inventory of consigned products, reconciling discrepancies between company records and products used or verified on-site, and returning or removing expired products.10
An overview of all the changes can be found here.
It behooves medical technology companies to review the new Code carefully and to update their company policies and procedures accordingly. For questions on the AdvaMed Code, U.S. healthcare regulatory laws and regulations, or FDA regulatory matters, please contact David Hoffmeister or any member of the FDA or life sciences practices at Wilson Sonsini Goodrich & Rosati.
David M. Hoffmeister and Eva F. Yin contributed to the preparation of this WSGR alert.
