The DEA is Targeting Oral Surgeons for “Black Bagging” and Other Registration-Related Offenses
The Drug Enforcement Administration (DEA), and its Diversion Control Division in particular, is aggressively targeting oral surgeons who prescribe and dispense antibiotics, pain medications, and other controlled substances as part of their surgical practice. While the DEA’s Diversion Control Division is targeting all types of Controlled Substances Act (CSA) violations, it is particularly emphasizing investigation of oral surgeons who engage in the practice commonly known as “black bagging.”
What is “Black Bagging”?
The term “black bagging” refers to transporting prescription medications from one medical site to another. This is a common practice among oral surgeons who travel between dentists’ offices and other medical facilities to perform procedures. However, it is also prohibited under the CSA.
Why is so-called “black bagging” prohibited? Under the registration provisions of the CSA, practitioners are required to obtain separate registrations for “each principal place of business or professional practice” where controlled substances are dispensed. Oral surgeons that prescribe and dispense medications qualify as “practitioners” under the CSA, as explained in the DEA’s Practitioner’s Manual:
“Under the CSA, the term ‘practitioner’ is defined as a physician, dentist, . . . or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which the practitioner practices . . . to distribute, dispense, . . . administer, or use . . . a controlled substance in the course of professional practice. . . .”
The purpose of this provision is to allow the DEA to maintain oversight of the locations where prescription medications are stored and administered to patients. Without such a provision in the CSA, practitioners could ostensibly keep prescriptions at their homes or at inadequately-secured office locations where may be more susceptible to loss, theft, diversion, or abuse. While this is at least arguably a valid concern, the strict nature of the CSA’s “place of business” provision means that various justifiable practices – including “black bagging” by oral surgeons – are outlawed as well.
Which Medications are Subject to the Rule Against “Black Bagging”?
All medications that are listed as Schedule I, II, III, IV, and V controlled substances under the CSA are subject to the prohibition against “black bagging.” This includes (but is not limited to):
- Penicillin VK
- Prescription-strength acetaminophen
- Other prescription antibiotics and painkillers
- Various types of anesthetics
In short, all medications that oral surgeons use are subject to the CSA’s “place of business” restriction. As a result, oral surgeons must be extremely careful to avoid transporting any medication to a location where they are not registered with the DEA.
What are the Penalties for “Black Bagging” Under the Controlled Substances Act (and Other Federal Laws)?
1. Civil and Criminal Penalties Under the CSA
Similar to the False Claims Act, the Anti-Kickback Statute, and many of the other federal laws that apply to oral surgeons, dentists, and other healthcare practitioners, the Controlled Substances Act includes provisions for both civil and criminal penalties. In civil cases (which are most common), oral surgeons can face civil monetary penalties (CMP) in the tens or hundreds of thousands of dollars per violation. In criminal cases, in addition to substantial fines, practitioners can also face federal imprisonment.
2. Suspension or Revocation of DEA Registration
However, oral surgeons accused of “black bagging” controlled-substance medications can face an additional form of punishment as well. Depending upon the circumstances involved (i.e. the volume of drugs transported, the frequency of unlawful transportation, and whether there is any evidence of intentional violation of the CSA’s registration requirements), oral surgeons can also potentially face temporary suspension or permanent revocation of their DEA registration. This, obviously, can have devastating consequences; and, in addition to seeking to avoid fines and prison time, oral surgeons who are under investigation for alleged “black bagging” must focus their defense strategies on protecting their DEA registrations (and potentially their state medical licenses) as well.
3. Prosecution Under Other Federal Healthcare and Criminal Statutes
Depending on the circumstances involved, oral surgeons targeted for alleged “black bagging” can potentially face prosecution under a number of other federal healthcare and criminal statutes as well. For example, billing Medicaid (or any other government benefit program) for illegally-transported and dispensed medications can trigger civil or criminal liability under the False Claims Act. “Black bagging” may also trigger investigation into an oral surgeon’s financial relationship with the dentist or other provider where the transported medications are unlawfully administered under the Anti-Kickback Statute; and, federal prosecutors will commonly pursue charges for attempt, conspiracy, and other crimes under a broad range of different circumstances.
What Other Registration-Related Offenses Do Oral Surgeons Need to Avoid?
In addition to “black bagging,” oral surgeons and other practitioners must be careful to avoid various other registration-related CSA violations as well. Similar to “black bagging,” commission of these offenses can potentially result in civil fines, criminal penalties, and temporary or permanent loss of DEA registration. Examples of other common registration-related violations of the Controlled Substances Act include:
- Storing, prescribing, and dispensing controlled-substance medications prior to issuance of DEA registration (i.e. prescribing medications while a DEA registration application is pending);
- Diverting medications to drug-dependent patients or patients for whom the medications are not medically-necessary;
- Concealing information from, or misrepresenting information to, the DEA during the registration application or renewal process;
- Prescribing, dispensing, or distributing any controlled-substance medication not covered by a practitioner’s DEA registration; and,
- Failing to generate and maintain all requisite forms of documentation for registered practitioners’ storage, prescription, dispensing, and distribution of controlled-substance medications.
What Should You Do if You are Facing a DEA Investigation?
When facing a DEA investigation, making informed decisions is the key to avoiding unnecessary – and potentially practice-threatening – consequences. This applies to all aspects of your response to the investigation, from dealing with DEA agents directly to developing a defense strategy focused on resolving the investigation without charges being filed.
1. Exercise Your Privilege Against Self-Incrimination
If DEA agents show up at your office or another facility with a search warrant, you may have little choice but to let them conduct a search and seizure (provided that the scope of the search should be limited to that authorized in the warrant). However, in the absence of a search warrant, you do not have to consent to a search of your office, your person, or your vehicle, and you do not have to say anything or provide any documents that could be used against you in court.
To exercise your privilege against self-incrimination, you can inform the DEA agents that you are not consenting to any search or seizure voluntarily, and you can state that you are requesting to speak with your attorney. You should then be able to contact an attorney immediately to get legal advice about your situation. From this point on, you should not say anything to the DEA unless advised to do so by your attorney.
2. Determine if You are at Risk for Civil or Criminal Prosecution
Have you engaged in illegal “black bagging” or any other DEA registration violation? Or, are you properly registered with the DEA (or does some other exception or defense apply to your situation)? When facing a DEA investigation, it is critical to quickly determine whether you could potentially be exposed to prosecution. If so, you must tailor your defense strategy accordingly. If not, you can use the evidence to convince the DEA that its efforts are misguided.
3. Do Not Assume You are Guilty
Just because you are under investigation by the DEA, this does not necessarily mean that you have committed a federal offense. DEA agents may fundamental misconceptions about the nature of your practice; or, they may be relying on unreliable information. At Oberheiden, P.C., we have had significant success helping clients avoid charges during DEA investigations, often by using our in-depth knowledge of federal law and procedure to convince the government that our client has fully complied with the law.
4. Do Not Assume You are Innocent
At the same time, it is equally important not to assume that you are innocent. The Controlled Substances Act, the False Claims Act, the Anti-Kickback Statute, and the other federal laws that apply to oral surgeons and other healthcare practitioners are extraordinarily complex, and it is very possible that there are statutory prohibitions of which you are unaware. Likewise, even if you have not knowingly or intentionally violated the law, you could still be at risk for civil prosecution.
5. Focus Your Efforts on Your Defense
At this point, you should be focusing your efforts on your defense. While this may be disruptive to your practice, the consequences of failing to defend yourself effectively could be far worse. Our senior healthcare fraud defense attorneys can help you understand everything you need to know, and we can help you make smart decisions while dealing with the DEA on your behalf.
Speak with a Federal Defense Lawyer about Your DEA Investigation
For more information about how Oberheiden, P.C.’s federal healthcare fraud defense lawyers can protect you during a DEA investigation, please contact us to schedule a free and confidential case assessment. To speak with a member of our defense team as soon as possible, call 888-680-1745 or send us your contact information online now.
Dr. Nick Oberheiden, founder of Oberheiden P.C., focuses his litigation practice on white-collar criminal defense, government investigations, SEC & FCPA enforcement, and commercial litigation.