Opioid Diversion and Civil Enforcement

Over the past few years, government agencies and the Department of Justice have cracked down on medical professionals they suspect may be distributing controlled substances, particularly opioid diversion, outside of the parameters of the Controlled Substances Act (“CSA”). Government enforcement efforts can include multi-agency task forces focusing on physician “pill mills,” pharmacists, and anyone else in the opioid supply chain. While the government frequently focuses on prescriptions or distribution of controlled substances “outside the usual course of professional practice,” investigators will also seek to attack the need for the medication itself to determine if there was a “legitimate medical purpose” behind the prescription.

While pursuing criminal prosecutions remains the number one priority, the DOJ is also increasingly using other tools to maximize its impact. The CSA, under Title 21 U.S.C. § 841, has long been the primary tool of government opioid “pill mill” and diversion criminal investigations; however, related fraud and financial crimes are frequently-used corrolaries to the Section 841 offenses. 

In recent years, however, DOJ has used the civil penalties provisions to punish physicians, pharmacists, and hospitals who DOJ believes have failed to meet with requirements of the CSA. Under the CSA, DOJ can seek civil penalties – up to tens of thousands of dollars – for each violation. Frequently, DOJ has used two provisions to pursue providers involved with alleged opioid diversion. 

  • First, DOJ can seek penalties for distributing or dispensing a controlled substance in violation of the CSA. 
  • Second, DOJ can seek penalties for providers who refuse or negligently fail to make, keep, or furnish any record, report, notification, declaration, order or order form, statement, invoice, or information required

The first provision is commonly used against physicians or pharmacists who the government believes inappropriate prescribe or dispense opioids. Prosecutors in Georgia have used this frequently to pursue millions of dollars in penalties. 

The second provision – failing to keep or make a required record – can be used even without any allegations of improper distribution or dispensation. This can occur in the event a pharmacy or hospital fails to keep track of inventories of opioids. The DOJ has recovered millions of dollars in penalties using this theory, including the then-largest penalty against a hospital

Of note, prosecutors may seek civil penalties as part of a parallel criminal proceeding or as part of a False Claims Act investigation. It is critical to seek out experienced counsel if you find yourselves as a target or subject of a federal investigation.

The attorneys at Griffin Durham Tanner & Clarkson are former federal prosecutors who represent clients in connection with DOJ investigations.  If you need assistance with such a matter, please contact us today.