Marking 10 Years: Past, Present, & Future Perspectives in FDA Law | Session 3 – Compliance

Healthcare compliance risk for FDA-regulated companies increasingly depends on how programs are structured, documented, controlled, and operationalized.

In this session from Gardner Law’s 10-year anniversary program, Marking 10 Years: Past, Present, & Future Perspectives in FDA Law, Amanda Johnston, Lisa Damhof, and Jake Leys discuss how compliance expectations have evolved and what companies should watch next.

The discussion focuses on practical compliance risk for companies operating in the medtech, biotech, pharma and food industries, including False Claims Act exposure, Anti-Kickback Statute risk, whistleblower activity, pricing and discount arrangements, speaker programs, and reimbursement support.

Topics include:

• False Claims Act recovery trends and healthcare enforcement activity.
• Qui tam matters, whistleblower risk, and DOJ enforcement priorities.
• How Anti-Kickback Statute concerns can create False Claims Act exposure.
• Pricing, discount, rebate, and bundled arrangement risk.
• Operationalizing discount structures so customers can accurately report discounts.
• Speaker program enforcement, including venue selection, repeat attendance, educational value, and sales or marketing influence.
• Recent enforcement activity involving speaker programs and HCP interactions.
• Reimbursement support programs, including benefits verification, prior authorization, appeals, and coding or billing guidance.
• How free services, provider burden relief, steering, and influence over outcomes can create compliance risk.
• Practical controls for building compliance programs that work in day-to-day operations.

This video is intended for legal, compliance, regulatory, reimbursement, sales, marketing, and business leaders in the medtech, biotech, pharma and food industries.

Presenters:

Amanda Johnston, Partner, Gardner Law.
Lisa Damhof, Associate Attorney, Gardner Law.
Jake Leys, Associate Attorney, Gardner Law.

This session is part of Gardner Law’s Marking 10 Years: Past, Present, & Future Perspectives in FDA Law program.

Learn more about Gardner Law: https://gardner.law.

Contact Gardner Law: office@gardner.law.

This recording is provided for educational purposes only and does not constitute legal advice.

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Видео Marking 10 Years: Past, Present, & Future Perspectives in FDA Law | Session 3 – Compliance канала Gardner Law