Webinar Recap: Practical Tips for Improving Your Compliance

On February 13, 2025, Gardner Law and Fredrikson co-hosted the Healthcare and FDA Compliance in 2025 CLE program, providing valuable insights into emerging regulatory risks and best practices for compliance success. During the session Practical Tips for Improving Your Compliance, Amanda Johnston and David M. Glaser provided expert insights into emerging regulatory risks, enforcement trends, and best practices for compliance.

Read the summary below for some highlights from the session, or check out the recording of the full session on our YouTube page. 

Emerging Regulatory Risks

A central theme of the session was the notable increase in whistleblower (qui tam) lawsuits, which reached a historic high of 979 cases in the previous fiscal year. These whistleblower actions accounted for a massive 82% of the Department of Justice’s False Claims Act (FCA) recoveries, totaling approximately $400 million. The DOJ has also introduced incentive programs creating a 120-day window for companies to self-disclose internal compliance issues following an internal whistleblower report. Companies that fail to self-disclose within this timeframe risk losing DOJ cooperation credit. To address this, organizations were encouraged to establish or enhance internal reporting mechanisms, enabling them to act promptly and decisively when potential issues arise. During the presentation, Amanda stressed the need to establish a process and culture of reporting:

"Whistleblower risk is really at an all-time high. Now’s the time to look at your internal reporting mechanisms and remind staff: we really want you to report concerns to us before you go to the government."

Compliance Tips and Pitfalls

Amanda strongly emphasized the importance of a comprehensive and proactive compliance throughout the discussion. Compliance programs should be continuously evaluated through risk-based assessments, aligning closely with DOJ and OIG priorities, including anti-kickback enforcement, Medicare Advantage fraud, and cybersecurity compliance. Recommended best practices highlighted by Amanda and David included implementing clear written policies, conducting regular training tailored to specific roles within the organization, and documenting compliance processes thoroughly to prepare for potential audits and investigations.

Several common compliance pitfalls remain significant areas of regulatory focus. Physician payments, particularly through speaker programs and arrangements involving lavish travel or disguised kickbacks, continue to attract scrutiny. Medicare Advantage fraud is increasingly under the DOJ’s spotlight, as are cybersecurity deficiencies, now actionable under the False Claims Act. Companies are advised to remain vigilant in these areas, ensuring their internal controls and policies adequately address these risks.

Responding to Investigations

Amanda and David also provided guidance on effectively responding to government investigations. They highlighted the critical importance of employee training on government interactions, particularly during the initial stages of an investigation. Organizations should establish clear, preemptive response plans to manage early communications effectively. Moreover, companies were advised against engaging in "silent recalls"—attempting to resolve compliance issues internally without proper government notification—as these practices are closely monitored and rigorously enforced by the FDA.

"If an investigator shows up, the first thing you do is ask for identification—they should have a Form 482. Then, immediately notify your internal FDA response team. Have a phone tree in place beforehand and clearly identify who's on call for that type of scenario."

Looking Ahead: How to Best Adapt to an Evolving Enforcement Climate

The regulatory landscape in 2025 is evolving rapidly, with whistleblower risks, state-level enforcement actions, and cybersecurity compliance becoming key areas of focus. Companies must remain vigilant in compliance monitoring, training, and internal reporting structures. To best safeguard your oganization, now is the time to review whistleblower policies, strengthen risk assessments, and proactively prepare for government inquiries. A proactive approach to compliance and risk management is essential. Contact Gardner Law for tailored compliance strategies for navigating regulatory challenges and mitigating risks.

Resources:
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