The Bass, Berry & Sims 13th Annual Healthcare Fraud & Abuse Review highlights key developments in healthcare fraud enforcement
NASHVILLE, Tenn., March 6, 2025 /PRNewswire-PRWeb/ -- When it comes to government enforcement, it is no exaggeration to say that the healthcare industry faces unprecedented uncertainty. That uncertainty stems in significant part from leadership changes and turnover within the key federal agencies responsible for civil and criminal oversight of the individuals and entities operating within that industry. In its 13th annual Healthcare Fraud & Abuse Review, Bass Berry & Sims attorneys provide a comprehensive analysis of how those changes will impact the enforcement environment, as well as assess other important developments of which the healthcare industry should take particular note.
The Review offers in-depth insights into enforcement trends, regulatory updates, and compliance challenges that healthcare providers, pharmaceutical and medical device manufacturers, and other industry stakeholders faced over the past year. Key topics include healthcare fraud enforcement updates, False Claims Act (FCA) developments, Stark Law and Anti-Kickback Statute enforcement trends, and developments in managed care and the pharmaceutical/medical device sectors.
"Our annual Review is designed to serve as a vital resource for healthcare organizations striving to navigate the complex and evolving regulatory landscape," said Brian D. Roark, co-chair of the firm's Healthcare Fraud & Abuse Task Force. "By analyzing recent enforcement actions and legal developments, we aim to equip our clients with the knowledge necessary to mitigate risks and maintain compliance."
Download the Healthcare Fraud & Abuse Review 2024.
Uncertain Enforcement Landscape
With a new administration, there is already new leadership at the Department of Justice (DOJ), Department of Health and Human Services (HHS) Office of Inspector General (OIG), and other federal agencies. There also will be new policies and new (or renewed) approaches to civil, criminal and administrative enforcement. "We expect to see a return to the same emphasis on deregulation that was a hallmark of the first Trump administration, and we have already seen a flurry of executive orders designed to pave the way for such an approach," said Matthew M. Curley, co-chair of the Healthcare Fraud Task Force. "Along with the rapidly unfolding executive branch changes, the stage has been set for further deconstruction of the administrative state by the Supreme Court's rejection of deference to federal agencies."
"Enforcement efforts in the coming year and beyond are also likely to be impacted by court challenges resulting in the possible paring back of some of the significant statutes and regulations upon which the federal government and whistleblowers rely in pursuing healthcare fraud recoveries, such as the False Claims Act and the Anti-Kickback Statute," Curley added.
Expanded Focus on Controlled Substances
In recent years, the federal government has increased enforcement efforts involving controlled substances and expanded the use of the Controlled Substances Act (CSA) as a means to addressing the opioid crisis. That effort has increasingly involved DOJ's pursuit of FCA cases stemming from alleged violations of the CSA. Last year, two settlements with retail pharmacies and DOJ's intervention in a third case highlighted this risk.
"The government's theory of liability in all three cases is that pharmacies violated the False Claims Act when they sought reimbursement from federal healthcare programs for prescriptions filled in violation of the CSA. Of course, FCA liability brings the potential for much higher monetary damages than enforcement of the CSA alone," said Lisa S. Rivera, a member of the Healthcare Fraud & Abuse Task Force and a co-chair of the firm's Controlled Substances Enforcement & Diversion Practice.
"Such cases signal the government's endorsement of this sort of FCA theory of liability. DOJ and whistleblowers undoubtedly will perceive CSA-based FCA cases as potential high-dollar opportunities for recovery," Rivera said.
Artificial Intelligence as Compliance Risk
DOJ's Criminal Division updated its previously issued compliance guidance in September 2024. The updated guidance incorporates previously announced compliance concepts to the many challenges posed by emerging technologies, including artificial intelligence (AI). "DOJ has made clear that healthcare companies should ensure that their compliance programs include a means by which risks associated with new and emerging technologies can be identified and managed," said Anna M. Grizzle, a member of the firm's Healthcare Fraud & Abuse Task Force who advises clients on enforcement and compliance-related issues.
"As AI and other new technologies take on an increasing role as part of the delivery of healthcare, companies must implement proper internal controls to ensure that emerging technologies are used for their intended purpose and that accountability over their use is monitored and enforced," Grizzle said.
Download the Review here; visit the Bass, Berry & Sims Healthcare Fraud & Abuse Resource Center, which features a database of more than 2,000 healthcare fraud settlements since 2012; and subscribe to the Inside the False Claims Act blog to stay up to date on FCA matters.
To complement the release of the Review, Bass, Berry & Sims will host a complimentary webinar on Thursday, March 20, 2025, from 11:00 a.m. to 1:00 p.m. CT, which will provide an overview and discussion of key focus areas covered in the Review.
About Bass, Berry & Sims PLC
Bass, Berry & Sims is a national law firm with more than 350 attorneys dedicated to delivering exceptional service to numerous publicly traded companies and Fortune 500 businesses in significant litigation and investigations, complex business transactions, and international regulatory matters. For more than 100 years, our people have served as true partners to clients, working seamlessly across substantive practice disciplines, industries and geographies to deliver highly effective legal advice and innovative, business-focused solutions. For more information, visit www.bassberry.com.
Media Contact
Erin Ihde – Senior Marketing Manager, Communications, Bass, Berry & Sims PLC, 1 (615) 259-6736, [email protected], https://www.bassberry.com/
SOURCE Bass, Berry & Sims PLC
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