Nashville, Tenn., (October 10, 2023) – Bass, Berry & Sims, a national law firm, today announced a new practice group to address the challenges of controlled substances diversion and heightened government scrutiny of healthcare providers under federal and state drug laws. The cross-disciplinary Controlled Substances Enforcement & Diversion practice helps Drug Enforcement Agency (DEA) registrants nationwide to identify and prevent controlled substances issues and navigate government enforcement actions under the Controlled Substances Act (CSA) and other laws.
“Our government enforcement team has developed significant experience helping healthcare providers across the country prevent, detect, and mitigate risk around drug diversion,” said Lisa S. Rivera, a former federal prosecutor, Nashville-based member and co-leader of the firm’s new practice group. “Our team has extensive experience conducting internal, civil and criminal investigations and vigorously defending allegations of drug diversion and noncompliance under federal and state drug laws. By creating a practice dedicated to controlled substances issues, we are ensuring we meet our clients’ needs in this space.”
Proactive Approach to Increased Scrutiny and Enforcement Trends
The Controlled Substances Enforcement & Diversion group assists clients with Department of Justice (DOJ) and DEA enforcement actions, unannounced DEA and Food and Drug Administration (FDA) onsite inspections, and drug diversion incidents. The group’s attorneys regularly respond to government investigations and conduct internal investigations, as well as respond to follow-up or disclosures to Boards of Pharmacy.
“We have seen increased government scrutiny of hospital inpatient and retail pharmacies, physician registrants and mail-order and less-traditional retail pharmacies,” said Brian Irving, co-lead of the practice group and also a Nashville-based member of the firm. “Controlled substances violations create enterprise risk because they can result in major penalties and years-long oversight and reporting requirements. They also present critical risks to patient care. Providers should make controlled substances compliance another top priority.”
The group also develops customized compliance programs to prevent drug diversion and offers in-depth compliance counseling to navigate complex regulations to remain compliant with the CSA, DEA regulations, and other laws. The team assists with policy development, risk assessment, prevention training, monitoring programs and other tools to mitigate risk.
Established Experience in Healthcare Compliance, Enforcement & Regulatory
The Controlled Substances Enforcement & Diversion group offers experienced government insight and credibility with regulators. Many group attorneys have formerly held leadership roles in organizations like the DOJ, HHS-OIG and other federal and state government agencies.
The firm has a well-established history of advising clients in the highly regulated healthcare industry, including national and regional health systems, pharmacies, behavioral health centers and physician groups in investigations, enforcement actions, regulator disclosures and remediation and compliance measures. Our firm’s deep experience in the pharmacy sector positions us to understand the challenges pharmacies face, particularly in connection to the CSA. We also frequently advise companies in mergers and acquisitions on diligence matters related to these areas of compliance.
About Bass, Berry & Sims PLC
Bass, Berry & Sims is a national law firm with nearly 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.
The announcement was covered in several media outlets, including:
- “Bass Berry Establishes Team for Drug Policy Compliance,” Law360 (October 11, 2023)
- “Legal Notes: Bass, Berry & Sims Launches New Practice,” Nashville Post (October 10, 2023)