What Is a Controlled Substances Audit?
The Drug Enforcement Administration (DEA) is the primary federal agency responsible for investigating illegal drug activity, including trafficking Schedules I and II substances such as heroin or cocaine.
They routinely conduct audits on pharmacies to ensure compliance with the Controlled Substances Act (CSA), which is why healthcare business owners must always stay prepared for a potential DEA pharmacy audit.
Due to the opioid crisis, pharmacies are increasingly "red-flagged" by the DEA for investigations over opioid transactions. You could lose your license or face felony federal criminal charges if you discover intentional or unintentional wrongdoing.
If you're under investigation by the DEA, you must retain experienced legal counsel to guide you through the process. It would be wise to have counsel for help with audits and inspections.
By getting legal representation early in the process, you are increasing your chances of a favorable outcome. Our California criminal defense lawyers will examine this topic further below.
What Specifically Happens During a DEA Audit?
The DEA performs routine inspections and audits of medical and pharmaceutical practitioners to ensure they comply with the CSA. These audits are regular, but administrative action can be taken against you for any violations.
When this happens, your DEA registration may be negatively affected, which is why you need to ensure you comply with federal laws and regulations.
These inspections usually happen once every couple of years or more often if the medical practitioner prescribes buprenorphine or other drugs to treat heroin addictions. A pharmacy must meet the requirements of the DEA audit to keep operating its business.
DEA diversion investigators perform DEA inspections and audits, usually part of the DEA’s Diversion Control Program.
A DEA audit will begin when a DEA Form 82, a “Notice of Inspection of Controlled Premises,” or an administrative inspection warrant is given to a DEA registrant before the inspection.
Suppose the DEA audits your prescribing or dispensing records. In that case, you should expect a request for a significant amount of documents, such as patient files, medical records, or financial records dating back many years.
The DEA investigators could interview you and your staff about prescribing or dispensing practices. If they discover CSA violations, they could take administrative or criminal action.
Administrative Search Warrant - Explained
If you decline to submit to the inspection, the DEA will secure an administrative search warrant from a Federal District Court even without probable cause. If they are investigating suspected criminal activity, then they have to obtain a search warrant before they can search for your practice.
To get an administrative search warrant, they must describe in detail the nature and extent of the inspection and any items seized. Federal court judges offer little to no resistance and routinely grant administrative search warrants.
Once the DEA presents an administrative search warrant for an audit or inspection, then you must comply. If you decide to refuse, you could face arrest.
Readers should note that an administrative search warrant doesn't give the DEA authority to inspect all aspects of your practice, but they are allowed to interview employees, which could be used against you.
If they discover non-compliance, they will write up and issue an audit report with the details. They have the option to refer the matter to the Department of Justice (DOJ) for criminal prosecution but usually take administrative action, such as the practitioner's DEA registration.
What Exactly Could Trigger a "Red Flag"?
The DEA looks for anomalies or "unusual" activities in prescribing and dispensing controlled substances. They are seeking evidence of violations of the United States Controlled Substances Act (CSA), but there are specific activities that generally trigger a red flag and make them suspicious.
This means you will be closely scrutinized and subjected to more audits, undercover stings, and potential raids. Some red flags include the following:
- A doctor prescribing an unregularly high amount of Schedule II prescriptions when compared to other types of drugs,
- A pharmacist filling the prescriptions of a large number of opioid prescriptions from the same doctor;
- A high number of cash payments for opioid prescriptions;
- Inventory irregularities and mistakes, such as billing for more opioids than were dispensed;
- If you fail to follow proper security protocols for storing or disposing of certain controlled substances;
- Failing to bill insurance companies for your services or having patients routinely travel long distances to visit your medical practice.
Tips to Avoid Being Targeted by the DEA
There are some steps you could take to minimize your risk of being red-flagged or investigated criminally, such as the following:
- You should keep detailed records of all your opioid transactions, including patient personal information and dosage;
- A regular examination of your prescribing and dispensing practices to make sure you comply with the CSA ad stay up to date on any changes;
- Make sure your employees are trained on CSA compliance and opioid prescribing and dispensing procedures;
- Report suspicious activity to the DEA if you have reason to believe a patient is doctor shopping;
- Conduct regular "self-audits" for CSA compliance.
Perhaps rather than waiting for the DEA to audit you, you should consider retaining a DEA audit attorney to examine your practice and highlight potential risk areas or non-compliance.
What Should You Do If Facing a DEA Investigation or Audit?
If you are facing a DEA audit or investigation or receive a notice of non-compliance, you need to consult with a qualified lawyer immediately. Don't take the situation lightly.
The DEA is very serious regarding these investigations and could red-flag you for accidental violations. You need to hire a lawyer seasoned in DEA defense, which can significantly reduce your risk of further punitive actions.
If you have been notified of non-compliance or discover that you will be federally indicted for CSA violations, hiring a skilled federal defense attorney might save your career and defeat the criminal charges early in the process.
We are experienced in handling DEA investigations and enforcement actions and can provide you with legal guidance throughout the process.
Please don't speak to the DEA without contacting our law firm to examine your situation's details. We can ensure your rights are protected and that the DEA investigators don't exceed the scope of their search warrant or legal authority under a DEA Form 82 inspection.
Eisner Gorin LLP is located in Los Angeles and provides legal representation for federal offenses to people across the country. You can contact us for an initial case consultation via phone or use the contact form.