What Are The Reasons for Controlled Substances Audits?
It's no secret that the Drug Enforcement Administration (DEA) is always on the lookout for illegal drug activity, including drug trafficking of Schedule I and II substances like heroin or cocaine.
They conduct audits on pharmacies in compliance with the Controlled Substances Act (CSA). This is why healthcare business owners must always be prepared for a DEA pharmacy audit.
But in the wake of the current national opioid crisis, healthcare providers and pharmacies are increasingly being "red-flagged" by the DEA for investigations over their opioid transactions. This means that even if you're acting in full compliance with the law, the DEA could still investigate you.
And suppose they find any evidence of wrongdoing on your part, intentional or unintentional? You could potentially lose your license to practice at best—or face federal felony charges at worst.
If you're currently under investigation by the DEA, you must seek out experienced legal counsel to help you navigate the situation.
It's even a good idea to hire a DEA defense attorney for assistance with routine audits and inspections. Bear in mind that by the time the DEA decides to refer your case to federal prosecutors, they will already have significant evidence against you.
Getting an attorney involved early in the process dramatically improves your chances of avoiding severe jeopardy to your livelihood or freedom. Our federal criminal defense lawyers will review this topic in more detail below.
What Happens During a DEA Audit?
The DEA performs routine inspections and audits of medical and pharmaceutical practitioners to ensure compliance with the CSA. While these are considered normal, they could take administrative action against your pharmacy if they discover that you have violated the CSA.
When this occurs, your DEA registration may be negatively affected. This is one of the primary reasons you must ensure that you and your pharmacy team consistently comply with federal laws and regulations.
These generally happen once every few years or more frequently if the practitioner prescribes buprenorphine or other drugs used to treat heroin addictions.
Your pharmacy has to meet the requirements of the DEA audit to continue operating its healthcare business. Preparing for DEA investigations can be intimidating.
DEA inspections are conducted by DEA diversion investigators located in different field offices across the United States. These investigators are usually part of the DEA's Diversion Control Program.
A DEA audit starts when a DEA Form 82, a “Notice of Inspection of Controlled Premises,” or an administrative inspection warrant is presented to a DEA registrant before the inspection.
If the DEA decides to audit your prescribing or dispensing records, they will likely request a considerable amount of documentation from you. This might include patient files, medical records, or financial records going back several years.
They will also likely interview you and your staff about your prescribing or dispensing practices. If the DEA finds evidence of CSA violations, it may opt to take administrative or criminal action against you.
What is an Administrative Search Warrant?
If you decline to submit to the inspection, the DEA will procure an administrative search warrant from a Federal District Court, which it can obtain without probable cause. If the DEA is actively investigating suspected criminal activity, it must obtain a search warrant before searching your practice.
To obtain an administrative search warrant, the DEA must describe the nature and extent of the inspection and any items they want to seize. Federal court judges routinely grant these types of search warrants.
If the DEA presents an administrative search warrant for an audit or inspection, you are required to comply. If you refuse, then you could be arrested. If you receive a DEA administrative search warrant, you need to contact a lawyer immediately.
An administrative search warrant does not give the DEA legal authority to inspect all aspects of the practice. The statute limits what they can inspect. They could attempt to interview you or your staff. Any information they receive can be used against you in an administrative or criminal proceeding.
If non-compliance is found, the DEA will issue an audit report with specific details. The DEA could refer the matter to the Department of Justice (DOJ) for a criminal prosecution, and they can take administrative action against the practitioner's or the facility's DEA registration.
What Could Trigger a "Red Flag"?
When it comes to medical providers and pharmacists, the DEA is primarily looking for anomalies or "unusual" activities in the prescribing and dispensing controlled substances.
Ultimately, it's looking for evidence of possible violations of the Controlled Substances Act (CSA), but even certain legal activities can trigger "red flags" if the DEA becomes suspicious.
These red flags make you subjected to increased scrutiny, and the DEA may subject you to increased audits, undercover visits, and possibly even raids of your practice. Examples of red-flag triggers may include:
- Prescribing an unusually high percentage of Schedule II prescriptions compared to other types of drugs, if you're a doctor;
- Filling too many opioid prescriptions from the same doctor, if you're a pharmacist;
- Having an unusually high number of cash payments for opioid prescriptions;
- Inventory anomalies and mistakes, e.g., billing for more opioids than were dispensed;
- Failing to follow proper security protocols for storing or disposing of controlled substances;
- Not billing insurance for your services;
- Having patients who travel long distances to see you, or worse, from out-of-state.
What Are Some Tips to Avoid Being Targeted by the DEA?
While it's impossible to avoid being audited by the DEA, there are steps you can take to minimize your risk of being red-flagged or investigated criminally. Some steps you can take include:
- Keeping detailed records of all your opioid transactions, including patient information, dosage, etc.;
- Regularly review your prescribing/dispensing practices to ensure compliance with the CSA;
- Staying up-to-date on changes to the CSA and state laws regarding opioids;
- Participating in required opioid education courses, e.g., for pain management;
- Ensuring that your staff is adequately trained on CSA compliance and opioid prescribing/dispensing procedures;
- Reporting any suspicious activity to the DEA, e.g., if you suspect a patient is "doctor shopping;.”
- Performing regular "self-audits" for compliance. Rather than wait for the DEA to audit you, consider hiring a DEA audit attorney to look into your practice and highlight potential areas of risk or non-compliance. Being proactive about compliance is the best way to avoid investigations.
What Should You Do If Facing a DEA Audit?
What if you are facing a DEA audit or investigation, or if you receive a notice of non-compliance? Even for so-called "routine" audits, it's essential never to downplay your interactions with the DEA.
The DEA takes its role very seriously and may flag you for accidental violations. If you receive notice of an inspection or are being more deeply investigated; having an attorney experienced in DEA defense can reduce your risk of further punitive actions.
If you are notified of non-compliance or discover you are being indicted for CSA violations, hiring an experienced federal defense attorney may save your career and help you avoid or beat criminal charges.
Our attorneys are experienced in handling DEA investigations and enforcement actions. We can provide immediate guidance to help protect you, your practice, and your DEA registration.
Before speaking to the DEA, you should first contact us to review the details of your situation. We can help ensure your rights are protected and that the DEA does not exceed the scope of their search warrant or their authority under a DEA Form 82 inspection.
Eisner Gorin LLP is a top-rated criminal defense law firm that provides legal representation to people across the United States for all types of offenses. You can contact us by calling (877) 781-1570 or filling out the contact form.
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