For decades, MedTech companies have referenced the longstanding AdvaMed Code for compliance guidance to ensure ethical interactions and relationships with U.S. healthcare professionals (“HCPs”). The revised Code, which becomes effective June 1, 2022, includes changes addressing alcohol, virtual interactions and meals, fair market value, and value-based care.

Key Code Updates:

• New and revised definitions - for example, the definition of “healthcare provider” - have been expanded to include individual clinicians as well as provider entities and their administrative personnel
• New information on the use of data analytics in the industry and the variety of ways companies will use data
• Processes for educating and training healthcare providers (HCPs) on appropriate use of a company’s devices and technologies
• Expanded information on consulting arrangements with HCPs
• New questions in the FAQ section on a variety of topics, including the provision of alcohol at company-sponsored events, similar to the recent updates to the PhRMA Code effective on January 1 of this year

What should you do now?

We recommend reviewing your existing compliance policies and procedures, compliance training content, and auditing & monitoring programs to identify changes necessary to align with new AdvaMed Code guidance.

• Review and update policy definitions and process steps for conducting engagements.
• Revise compliance training content and materials to provide updated information in line with AdvaMed guidance and company policies and SOPs.
• Make sure auditing & monitoring processes and materials enable the assessment of new and updated guidance and changes in your own policies.

How can IQVIA’s compliance consulting team help?

We understand how busy you are, and realize how time-consuming the process is to review, update, gain consensus among all the reviewers, and then train everyone on the updated guidance.

• We will conduct a thorough review of your compliance materials, identify necessary updates, and then work with you to implement the changes, including facilitating the internal review process, communicating with the appropriate stakeholders, and conducting informational sessions for specific audiences.
• We can help after implementation by auditing & monitoring certain activities to make sure guidance provided in your policies and training programs are followed.
• We also have a data analytics solution to help you independently assess risks across your organization to make sure the changes and training have been implemented successfully.

For additional information or to speak with a representative from our Commercial Compliance Consulting team, please visit Commercial Compliance - IQVIA.