DEA Audit Attorney in Contra Costa County
What is the DEA?
The DEA is an arm of the U.S. Department of Justice. The DEA has the legal authority to make unannounced inspections of physician’s offices, controlled substance storage locations, laboratories, pharmacies and any location that is licensed to store or dispense controlled substances. Never forget that the DEA is a law enforcement agency with special powers. These powers include the right ability to assess civil and criminal penalties. These penalties can be a simple letter of admonition but even a letter of admonition will trigger a medical board inquiry. Our physician lawyers view a DEA audit as a red flag for a larger investigation.
What is a DEA Audit?
As the DEA regulates the prescription, storage and distribution of controlled substances an audit is a law enforcement search of premises and records for compliance with the rules and regulations. In other words, this is not just an audit. It is an audit that can be part or or grow into a criminal investigation.
The audits are often routine. In and out comparisons and record review can be both cursory and while unexpected, uneventful. However, DEA audits can be daunting if your practice is not set up for accurate tracking of distribution and prescription writing. A 2011 case is typical of an honest medical practitioner and pharmacy being fined after a DEA audit.
DEA Audit (Example)
In the case of Dr. H Aaron Blaser a dentist in Ketchum, Idaho, the DEA found a shortage of approximately 72,100 milligrams of Demerol. An audit of a nearby pharmacy revealed an inability to account for a quantity of opiates. No criminal wrongdoing was alleged but a $ 35,000 civil fine was imposed. In most states this fine would also result in a medical board investigation. Violations of this type would result in more serious sanctions in today’s opioid panic environment. While the Blaser case was a tracking issue, we have seen a significant uptick in DEA citations for storage issues. Again, fines can be imposed even without any deliberate wrongdoing. Even 12 years after the event, the DEA press release still “tags” Dr. Blaser with this citation.
Preparing for a DEA Audit
A hostile DEA inspection will be designed to catch you off guard. If the DEA inspects late in the day or at holiday time, this is a red flag that they are looking at potentially serious violations. But regardless of whether the inspection is hostile (suggesting suspicion of criminal conduct) or truly civil or administrative, certain standards will apply.
[Note that in larger practices or practices that are at high risk, we recommend trainings to prepare for a DEA sudden audit. We make certain that staff is aware of the applicable federal and state, regulations, storage regulations and audit compliance procedures. In particular, audit related records (in/out) records in particular should be readily available and internally consistent.]
Electronic Prescriptions – Be Careful
DEA audits, rule violations and controlled substance prescription abuse are a constant threat to practices that rely significantly on controlled substances for proper patient care. Changing opioid prescription rules, underground regulations and political pressures can lead to a DEA audit or medical board investigation. It is important to ensure that your electronic practices are consistent with current rules. Our physician lawyers can review your practice to ensure that you are DEA compliant.
Telemedicine or electronic prescriptions are addressed by DEA regulations which specify the conditions under which controlled substance prescriptions may be issued electronically. Before any electronic prescription or pharmacy application may be used to transmit prescriptions, a third party must audit the application for compliance with the requirements of 21 CFR part 1311. Alternatively a certifying organization whose certification process has been approved by DEA must verify and certify that the application meets the requirements of 21 CFR part 1311.
What are the DEA Rules?
You need to access accurate summaries of the DEA rules or better yet, review the rules themselves. The DEA storage Rules are found at 21 CFR 1301.71. Have you ever scanned (or even read in detail !) The rules are right there in Chapter 2 of the CFR’s (21 CFR Chapter 2) Take the time to read them and our pre-audit investigation can assist you in making sure you are compliant.
The office should have a discreet location for the inspection record review to take place and do not be shocked when the licensee/registrant of the facility is required to sign a DEA 82 form which is voluntary consent to the search/audit. Likewise do not fumble for keys or codes to access storage locations for controlled substances.
You should expect to produce
- Current usage logs
- Disposal records• Access to controlled substance storage cabinet or safe
- Purchasing records which will include invoices, packing slips, DEA Form 222 records.
Each scheduled substance should have a separate folder.
- Waste or breakage-spillage reports (DEA Form 41)
- Theft/significant loss reports (DEA Form 106)
We recommend recording the audit although this may be seen as a hostile act by some DEA investigators. In the balance however, it is useful if the audit is overly aggressive or has significant negative findings which you intend to contest.
If the audit is routine the DEA may verbally or in writing provide suggestions for improvement. This is usually done in good faith and is not an investigative tactic. Be careful however in asking questions as the question itself may open a new area of investigation.
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