Policy & Medicine Compliance Update
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April 2021
Issue Summary:
For our April issue, we continue our review of major compliance events and trends with a focus on the Federal False Claims Act (“FCA”). We start by examining the overall FCA trends and recoveries in FY 2020. Despite the pandemic, it was an active year for FCA cases. Next, we dive into some of the crucial decisions shaping the development of new cases. These cases impact central elements of FCA cases, as well as government interventions and dismissals. Finally, we examine the latest settlement involving electronic health records (“EHR”) providers and what it signals for the future.
Switching to Governance & Operations, we conclude this issue with an insightful discussion from the Deloitte team on how compliance professionals can turn recent privacy developments into a competitive advantage.
Still A Potent Weapon
FCA Cases Resolutions in FY 2020 Show Smaller Recoveries, But A Bright Future
By Gwendolyn A. Ball, Staff Writer
Summary: FY 2020 False Claims Act recoveries total $2.2 billion, a decrease from previous years. Healthcare sector recoveries also fell to $1.9 billion, the first time in ten years that the total was below $2 billion. However, FCA filings were up in FY 2020, particularly non qui tam filings by the government. The increased number of filings as well as settlements already seen in FY 2021, suggest that settlements and recoveries should be higher, perhaps much higher, in coming years.
Litigation and Enforcement
Muddy Clarity
Examining the Important FCA Decisions of FY 2020
By Gwendolyn A. Ball, Staff Writer
Summary: During FY 2020, the appellate courts entered several opinions regarding central elements of FCA cases and government interventions and dismissals. However, these decisions did little to provide final clarity on several key aspects of FCA law.
A Target Rich Environment
EHR Providers Feel the Bite of Health Care Fraud Enforcement
By Kirt Kraeuter, Staff Writer
Summary: In January 2021, another EHR provider reached a settlement with the Justice Department over allegations of kickbacks and false claims. The Athena case represents the fourth significant settlement in the past five years, demonstrating that the DOJ will not hesitate to use the AKS and the FCA to address perceived illegal activities perpetrated by EHR providers. Therefore, these cases serve as cautionary tales for all vendors supporting health care entities.
The New World of Privacy
Moving from Compliance to Competitive Advantage
By Daniel P. Frank, principal and Eric Bowlin, partner, Deloitte & Touche LLP
Summary: Implementation of the European Union’s General Data Protection Regulation and similar regulations has catapulted privacy to a major compliance risk for many companies. As a result, life science compliance leaders should educate themselves on privacy concerns and executives should be aware of four emerging privacy trends that may impact how they manage ever-increasing patient privacy expectations.