Medical Technology Compliance: FDA, AKS, FCA and Other Regulatory Requirements

The medical device industry is heavily regulated, and companies must follow strict guidelines. Due to confusion over implementing the regulations, healthcare companies often miss important compliance matters. The FDA can audit medical technology companies at any time, and counsel must prepare these companies.

Further, the government’s False Claims Act (FCA) enforcement continues to focus on key areas in pharmaceutical and medical device industries. In 2016, the healthcare industry paid $2.5 billion in settlements and judgments from FCA cases.

Similarly, the enforcement of the Anti-Kickback Statute (AKS) has been costly for companies. For example, medical device maker Olympus Corp. paid over $600 million to settle criminal and civil AKS and FCA charges in 2016.

Listen as our authoritative panel of healthcare attorneys examines the unique risks for medical technology companies and provides guidance on implementing appropriate and effective compliance programs. The panel will discuss AKS, FCA and other fraud issues as well as the key pitfalls to avoid.

1. Unique risk profile for medical technology companies
   1. Evolving regulatory landscape
   2. Ever-increasing compliance requirements
   3. Safety, security and reliability
   4. Managing data
2. Unique operational considerations for medical technology companies
3. Tips on implementing a “right sized” compliance program
4. “Toolkit” for fighting healthcare fraud
   1. Anti-Kickback Statute
   2. False Claims Act
   3. Open Payments/Sunshine Act
   4. “Whistleblower” suits
5. Core components of effective compliance program
6. Key questions to consider

The panel will review these and other key issues:

• What are the unique risks facing medical technology and device companies?
• What are the key pitfalls to avoid when implementing compliance programs?
• What steps should counsel take to ensure compliance with FCA and AKS?