A frantic colleague called me last month, saying he had a Drug Enforcement Administration agent (aka, the DEA) in his waiting room and asking what he should do. I asked if his office was ready – did his office have an audit readiness file, all processes defined in the DEA Practitioner’s Manual, good recordkeeping systems, a reconciliation process, and inventory and purchase order records from two years ago? I could tell from the hesitation in his voice that he had no idea.
Luckily, his office was in good enough shape that he passed, but just barely. As he put it, “they painfully passed me, but I now have to comply with several strict recommendations.” After hearing about his experience, I decided to put together some information for OMS practices about DEA compliance. My hope is that you can use this information to prepare your office and avoid the stress and serious risk that my colleague faced.
This article consists of three parts: 1) how to prepare for a DEA audit, 2) how to conduct a self-audit of your practice’s controlled substances, and 3) what to expect if the DEA does audit you. I think that if you prepare and then know what to expect, you’ll have a successful (and much less harrowing) experience with the DEA.
Part 1: How to Prepare for a DEA Audit
This is no easy task, but it is critical. You’re responsible for everything in the Practitioner’s Manual: An Informational Outline of the Controlled Substances Act (available here on the DEA website). This document, last updated in 2006, gives you a summary and explanation of the processes you must follow to stay in compliance with the federal Controlled Substances Act. Following this manual to a T will significantly reduce your risk during a DEA audit.
Especially given the current opioid epidemic in the U.S., compliance is imperative to the health of your practice and to your community. By complying, you can ensure your practice is meeting its responsibilities for registering, recordkeeping, following valid prescription requirements, and implementing safeguards to prevent controlled substances from getting into the wrong hands.
There are several key actions you can take at your practice:
- Create and prepare an audit readiness file. Click here for instructions on how to create an Audit Readiness File.
- Ensure all processes in your practice comply with the Practitioner’s Manual: An Informational Outline of the Controlled Substances Act.
- Train all surgical staff on good record keeping.
- Create a substance policy template.
- Conduct a self-audit of your practice’s controlled substances (see Part 2 of this series) and adjust your operations to address any shortcomings.
- Identify an employee or two to manage your practice operations of controlled substances.
- Periodically review and update your policies to ensure they’re in compliance with DEA regulations.
- File controlled substances reports on a daily basis and keep records for at least two years, or longer if required by state law.
- Keep controlled substances in a secure area, including those awaiting return or destruction, and change access measures after authorized employees depart your practice. Inspect your security systems regularly.
- Do your due diligence in documenting suspicious activities.
Remember, compliance is a process, not a state of being. It takes knowledge, effort, and clear communication with everyone involved to make DEA compliance happen—and continue to happen. Here are some ways to tackle this:
- Hire a compliance coach: OMS Consulting Firm can provide on-site or remote training, support, and documentation to help your practice reach your compliance goals. Contact us for more information about how to get started.
- The do-it-yourself approach: this reduces your out-of-pocket costs, but does cost your time or the time of a competent staff member that you trust. To do this, you’ll need to learn about and implement:
- The Controlled Substances Act and the corresponding Practitioner’s Manual
- Other state and/or federal requirements regarding controlled substances
- Purchase training modules on DEA compliance: On this path, you’ll get some training and then, of course, do it yourself to implement what you learn. Some training options include (note: these are not endorsements, but options available online):
- CRx Controlled Substance Compliance Program
- The Pharma Compliance Group
- American Association of Oral and Maxillofacial Surgeons (AAOMS)
- Southern Anesthesia & Surgical, Inc.
- Dental supply vendors’ websites
- Law firms that specialize in DEA Compliance
- Get Accredited: Accreditation allows you to voluntarily submit your practice to a third-party review of your compliance with all regulatory requirements. Your practice will be scrutinized according to numerous criteria and then need to make adjustments to improve your compliance processes. These accreditation procedures cost money and time, but an added advantage is that accreditation organizations usually offer (and strongly encourage) opportunities to brand and market your organization as having achieved their formal seal of approval. Presently, the Accreditation Association for Ambulatory Healthcare is an accreditor for office-based OMS surgical centers.
By taking steps toward compliance with the Controlled Substances Act, you’ll reduce your practice’s risk and be better prepared in the event the DEA shows up at your door for an audit.
Keep reading this series to learn more about DEA compliance at your practice:
- Part 2 is about how to conduct a self-audit
- Part 3 tells you what to expect if the DEA does arrive at your practice for an audit
OMS Consulting Firm’s team of experts can offer guidance and hands-on improvements for your practice’s compliance program. Contact us for more information.