Our national Controlled Substances Enforcement & Diversion practice helps DEA registrants across the country identify and prevent controlled substances issues and navigate government enforcement actions. Our cross-disciplinary team has extensive experience conducting internal, civil and criminal investigations and vigorously defending allegations of drug diversion and noncompliance under the Controlled Substances Act (CSA), Food, Drug and Cosmetics Act (FD&C Act), and other federal and state drug laws.
- Increased scrutiny: Spurred by the opioid crisis and perceived increases in diversion, the government has stepped-up its enforcement efforts for all types of controlled substances and all entities within the controlled substances supply chain, including healthcare providers.
- Proactive enforcement: Government regulators are taking a more proactive and aggressive approach to controlled substances diversion and the enforcement of federal and state drug laws. The Drug Enforcement Administration (DEA) and other government agencies are more frequently identifying issues through unannounced onsite inspections and data analysis, in addition to provider self-reporting obligations.
- Enforcement trends: The government is targeting hospital inpatient and retail pharmacies; physician registrants; and mail-order and less-traditional retail pharmacies, ensuring that those entities will continue to receive scrutiny going forward.
- Holding providers accountable: When the government discovers compliance issues or diversion, it now demands to know how these issues occurred and seeks to hold DEA registrants accountable for alleged violations at their facilities and shortcomings in their controls. The government’s heightened enforcement coincides with industry and regulatory changes that can complicate compliance efforts and lead to even more risk.
- Significant consequences: CSA and FD&C Act violations can lead to substantial penalties and years-long oversight and reporting requirements. In a clear sign of the government’s growing enforcement focus, the U.S. Department of Justice (DOJ) is more frequently handling controlled substances and diversion matters. As a result, controlled substances violations and diversion events have led to significant criminal and civil enforcement actions and settlements in recent years.
Providers should recognize that controlled substances violations and diversion present substantial enterprise risk and should make it a top priority to detect, prevent and mitigate risk around drug diversion.
Our Unique Experience
We have assisted clients – including national and regional health systems; national specialty, mail-order and retail pharmacies; behavioral health centers; and physician groups – with internal investigations for potential drug diversion, timely disclosures to regulators, and remediation and compliance measures. We routinely represent clients in investigations, enforcement actions, and negotiations with federal and state agencies and regulators including DOJ, DEA, Food Drug Administration (FDA), Department of Health and Human Services Office of Inspector General (HHS-OIG), state departments of health, and boards of pharmacy and nursing, among others.
- Unparalleled experience: We are the “go to” firm when healthcare providers face full-blown crises involving DOJ and DEA enforcement actions, DEA and FDA unannounced onsite inspections, and drug diversion incidents. Members of our team regularly respond to government investigations and conduct internal investigations. In the last year alone, we have advised numerous national and regional health systems, pharmacies and physician groups in this area, and resolved criminal, civil and administrative matters with DOJ, DEA and other administrative agencies.
- Proactive approach: We regularly develop customized compliance programs to detect and prevent drug diversion. Our team provides comprehensive compliance counseling to help healthcare providers navigate complex federal and state regulations to remain compliant with the CSA, DEA regulations, state prescription drug monitoring programs (PDMPs) and other laws. We assist with policy development, risk assessment, prevention training, risk assessments, monitoring programs and other tools to mitigate risk.
- Strategic advice: Our attorneys regularly present to senior leadership and boards of directors on compliance and enterprise risks, in both proactive efforts and in response to DOJ, DEA or other enforcement demands. Our team also assists in messaging to internal and external stakeholders.
- Due diligence: Leveraging our experience in this area, we also assist providers in healthcare transactions with due diligence and indemnification related to potential controlled substances violations and risk.
- Government insight: Many of our attorneys previously held leadership roles in DOJ, HHS-OIG and other government agencies, giving us valuable insight in advising clients on enforcement matters and related issues. This experience provides us with important credibility in our dealings with regulators. We also have strong working relationships with former government regulators who now serve as industry consultants, and use their expertise in representing and advising our clients.
- Unmatched healthcare regulatory knowledge: As regulatory counsel to more than 200 healthcare companies, we have a deep understanding of the regulatory and reimbursement environment. This experience enables us to develop innovative solutions to manage risk and to employ that knowledge on our clients’ behalf in enforcement matters, as well as to anticipate and advise on related issues during diligence and in healthcare transactions.
- Pioneers in pharmacy law: Our team includes industry veterans who have experience as both in-house general counsel and outside counsel in the pharmacy space. We serve as operational and transactional counsel to a majority of the nation’s largest specialty pharmacies. We regularly handle high-stakes investigations for pharmacies. As a result, we have a deep understanding of the unique issues facing pharmacies particularly as they relate to the CSA.
With deep experience, a successful record and best-in-class compliance counseling, our Controlled Substances Enforcement & Diversion practice is proud to collaborate with healthcare providers to address the ongoing challenge of controlled substances diversion and the heightened scrutiny of CSA compliance.
