New Advamed Ethics Code for Medical Device Manufacturers: Are You Ready?
In January 2019, the Advanced Medical Technology Association (AdvaMed) approved an updated version of its Code of Ethics on Interactions with Health Care Professionals, with the new version of the Code going into effect at the beginning of next year.
In the roughly 10 years that have ensued since the trade association of medical technology manufacturers’ last ethics Code update in 2009, technology and regulatory changes have been happening at a pace that would have been almost unimaginable a decade ago.
Although the Code is a voluntarily observed set of guidelines to help device makers observe best practices in their HCP interactions, it provides a baseline for adherence to the Anti-Kickback Statute and other regulations. In a statement, AdvaMed president and CEO Scott Whitaker said, “The updates reflect evolving legal standards, care delivery models and best practices . . . and are designed to ensure the Code’s continued effectiveness.”
The Code that will take effect January 1, 2020 contains both new sections and consolidations/clarifications of which MedTech professionals must be aware to maintain compliance with industry guidelines.
New Code Sections
Jointly conducted marketing and educational programs: A MedTech company may partner with a healthcare professional (HCP) to provide marketing and educational programs; however, the company must apply, among other things, the following guidelines:
- There should be a legitimate, documented need for the HCP’s services
- The Company should implement some controls to ensure that the arrangement does not become an unlawful inducement
- The arrangement should be in writing and set forth the roles, responsibilities, and contributions of each party equitably
Communicating for the safe and effective use of Medical Technology: This section establishes principles and guidance for communications related to the use of Company’s products, including:
- Information must be truthful and non-misleading
- Information related to unapproved or uncleared uses should be identified/labeled as such
- Responses regarding unapproved uses should be provided by authorized company personnel
Company representatives providing technical support in clinical setting: This section develops a framework for company representatives to follow when providing technical support on the safe and effective use of medical technology More specifically:
- Company representatives should enter the clinical setting only at the HCP’s request and supervision
- While on site, company representatives must identify themselves as members of their organization, comply with facility policies, and not interfere with clinical decisions
Companies’ technical support should not eliminate an overhead or other expense that the HCP would otherwise incur while providing patient care.
Code Consolidations, Clarifications, and Updates
In addition, the Code has updated and consolidated practice guidelines for legitimate consulting needs with HCPs, hotel and meal expenses, third-party programs, grants, sponsorships and donations.
These are not minor tweaks, and the MedTech industry has a narrow window of time in which to implement these changes to be in compliance with the Code. If they have not already, device manufacturers need to urgently prioritize analysis of their promotional, educational and communications protocols. Establishing an institutional framework for monitoring and analysis is the gold standard. Can your technology provider partners deliver this?
As equipment and devices become more advanced, medical technology is a rapidly evolving field, and a constant state of change is the new norm. Working with a trusted third-party vendor that operates according to a compliance-centric paradigm is the most reliable way to avoid running afoul of compliance pitfalls. Inadvertent mistakes overlooked activities or even incomplete record-keeping can put a company in legal jeopardy.
IQVIA Commercial Compliance can help. Our consulting, technology, and managed services comprise a full suite of solutions that solve your toughest compliance and engagement challenges. From risk assessments and process design and implementation, to end-to-end HCP and HCO engagement management, transparency reporting solutions, and more, IQVIA is your trusted compliance partner.
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