As a health care provider who prescribes or dispenses medications to patients, your practice is subject to oversight by the Drug Enforcement Administration (DEA). In addition to maintaining your DEA registration, you must ensure ongoing compliance with the Controlled Substances Act (CSA) in order to avoid administrative action by the DEA and the potential for criminal prosecution by the U.S. Department of Justice (DOJ).
For most health care providers, the extent of their interaction with the DEA involves applying for registration and dealing with regular inspections (or “audits”), which the DEA typically conducts about once every three years. But, the DEA is increasingly targeting legitimate health care providers in drug diversion and other health care fraud investigations. And these investigations – which can lead to serious criminal charges – are often presented as routine “audits” as well.
Whether you are in the process of applying for DEA registration, you own or manage an established practice and are facing a “routine” audit, or you are facing a criminal investigation, it is important to understand what you can expect when DEA agents contact you or show up at your door. Knowing your rights and obligations (and how to tell the difference) is critical to making informed decisions. And making informed decisions is the only way to ensure that you do not expose yourself and your practice to unnecessary government scrutiny.
What to Expect during a DEA Audit or Inspection
1. Request for Informed Consent
Most DEA audits start with the issuance of DEA Form 82. Although this form is titled “Notice of Inspection of Controlled Premises” rather than being a simple “notice,” it is actually a request for consent for the DEA to examine your practice’s records without a search warrant.
While granting informed consent pursuant to DEA Form 82 will be fine for many practitioners and health care practice managers, signing off is not a decision to be taken lightly. There are legal implications to authorizing the DEA to examine your books and records. And if the audit reveals evidence of criminal misconduct, you will have already consented to use of this evidence in your criminal trial.
In some cases, a DEA audit will begin with the issuance of an administrative search warrant rather than DEA Form 82 (and, if you refuse consent, the DEA can still move forward by obtaining a warrant). If the DEA obtains an administrative search warrant, it does not need your consent in order to move forward with its audit. Then, there are situations in which the DEA is seeking to conduct an “audit” as part of a broader criminal investigation. In this scenario, the agency must obtain a judicial search warrant before entering your premises. Finally, there are limited circumstances (e.g., in response to an initial request for registration) in which no formal request or authorization is required.
The way in which your audit is initiated will tell you a lot about what you can expect during the remainder of the process. As a very general rule, audits conducted pursuant to DEA Form 82 tend to be less intrusive, while audits linked to criminal investigations have much more at stake for all of the parties involved. But, with the potential to result in loss or denial of DEA registration, loss of medical licensure, and federal prosecution, all audits need to be taken very seriously.
2. Request for Patient Records and Billing Files
After the initial step of gaining lawful entry to your premises, DEA agents will then begin an exhaustive review of your practice’s patient records and billing files. You can expect this review to take a significant amount of time, to be fairly invasive, and to involve requests for your active participation in the process. Once again, when dealing with the DEA (or any federal law enforcement agency), it is critical to make sure that you are making informed decisions based upon reliable legal advice.
3. Close Scrutiny of Your Prescription Drug Practices
While DEA audits can have a number of different focuses depending upon the specific purpose for which they are being conducted, regardless of the rationale (or pretense) for your audit, you can expect close scrutiny of your prescription drug practices. Remember, DEA stands for Drug Enforcement Administration. If DEA agents find evidence of drug diversion or prescription fraud, they will refer your case for criminal prosecution.
4. Request for Voluntary Surrender
Another common tactic in DEA audits is the request for voluntary surrender. This is just as it sounds: a request for you to voluntarily surrender your DEA registration without a formal, evidence-based revocation. While, here too, it can be in some providers’ best interests to comply under appropriate circumstances, no provider should surrender his or her registration unless advised to do so by legal counsel.
5. Order to Show Cause
If your audit is related to an application for DEA registration, following its investigation, the DEA may issue an Order to Show Cause. This is a denial of your DEA registration application. If you receive an Order to Show cause, you will need to request a Show Cause Hearing. And if you receive an unfavorable determination at the hearing, you will need to file an appeal in order to preserve any opportunity to prescribe or dispense controlled substance medications as part of your practice.
6. Audit Report of Noncompliance
If the DEA concludes that you are practicing in violation of the CSA, it will issue an audit report detailing all of the ways in which your practice appears to be noncompliant. This is an extremely serious outcome, as it is likely to result in further investigation by the DOJ.
7. Investigation Targeting Potential Health Care Fraud
In any case, facing a DEA audit increases your risk of facing a health care fraud investigation. As you go through the process, it is important to be aware of the signs that the DEA may be doing more than simply conducting a routine inspection. At Oberheiden, P.C., we have extensive experience representing health care providers in DEA audits nationwide, and we can help mitigate your risk of DEA registration revocation or denial and other life and practice-altering penalties.
Contact Us about Your DEA Audit
For more information about our experience in DEA audits and investigations, please contact us to schedule a free, no-obligation consultation. To speak with federal law defense attorney, Dr. Nick Oberheiden, in confidence, call (214) 469-9009 or request an appointment online today.