Former DEA Agents and Investigators Providing Comprehensive Audit Defense Services
The U.S. Drug Enforcement Administration (DEA) audits registered healthcare providers and pharmacies to assess compliance with the Controlled Substances Act (CSA) and other federal laws and regulations. During these audits, DEA agents thoroughly examine registrants’ books and records, and they examine all aspects of providers’ and pharmacies’ prescription drug practices. While technical violations can lead to administrative consequences, more-serious violations can lead to civil enforcement action—and even criminal prosecution in some cases.
With this in mind, healthcare providers and pharmacies that are facing DEA audits need to execute a coordinated and strategic defense. At Corporate Investigation Consulting, we rely on centuries of relevant experience to assist our clients with this process. Not only do we have extensive experience providing DEA audit defense services, but several of our consultants previously conducted audits and oversaw investigations at the DEA.
Put our highly experienced team on your side
Roger Bach
Former Special Agent (OIG)
Timothy E. Allen
Former Senior Special Agent U.S. Secret Service
Chris J. Quick
Former Special Agent (FBI & IRS-CI)
Maura Kelley
Former Special Agent (FBI)
Ray Yuen
Former Supervisory Special Agent (FBI)
Michael S. Koslow
Former Supervisory Special Agent (DOD-OIG)
Marquis D. Pickett
Special Agent U.S. Secret Service (ret.)
We Put Former DEA Agents and Investigators On Your Side
When you are dealing with a DEA audit, experience matters. You need to know what to expect during the process, and you need to be able to anticipate potential outcomes so that you can adjust your defense strategy in real-time. When you choose Corporate Investigation Consulting for your practice’s or pharmacy’s DEA audit, your team will include:
- Kristy Smith, Former DEA Diversion Investigator – Kristy Smith is a former DEA Diversion Investigator who led major audits and investigations for the DEA before joining the private sector. She has extensive knowledge of the DEA’s auditing strategies and methodologies, and she uses this knowledge to help clients favorably resolve their audits as efficiently as possible.
- Roger Bach, Former Executive Assistant to the New York DEA Special Agent-in-Charge – Roger Bach spent more than 30 years working inside the government at the DEA, Office of Inspector General (OIG), and other agencies. He has extensive experience on both sides of federal audits and investigations, with a particular focus on matters involving healthcare providers and pharmacies.
- James Hunt, Former DEA Special Agent-in-Charge – James Hunt is also a former Special Agent-in-Charge at the DEA. Mr. Hunt spent much of his DEA career in New York, leading the Administration’s largest office and overseeing countless audits and investigations into healthcare providers, pharmacies, and other entities. Before moving to New York, Mr. Hunt also spent time at the DEA’s Miami Field Division and its Special Operations Division in Chantilly, Virginia.
5 Risks for Healthcare Providers and Pharmacies in DEA Audits
Regardless of the circumstances involved, facing a DEA audit presents several substantial risks. Even for healthcare providers and pharmacies that have fully complied with the CSA, the Drug Supply Chain Security Act (DSCSA), the DEA’s electronic prescription regulations, and all other pertinent sources of authority, avoiding unnecessary consequences requires a proactive defense. DEA agents expect to see affirmative proof of compliance; and, if providers and pharmacies are not able to demonstrate their compliance effectively, this alone can lead to an unfavorable outcome. With this in mind, here are five of the main risks involved with facing a DEA audit:
1. Inability to Effectively Assess Compliance
When facing a DEA audit, it is essential to know what (if anything) DEA agents are going to find. This is the only way to build and execute a focused defense strategy. Upon learning of an impending DEA audit, providers and pharmacies should immediately engage an outside consulting firm to assess the efficacy of their DEA compliance programs.
2. Inability to Effectively Demonstrate Compliance
As we mentioned above, during a DEA audit, the inability to effectively demonstrate compliance can be just as dangerous as non-compliance. To avoid unnecessary consequences, providers and pharmacies must be able to use the documentation they have on hand to convince the DEA’s agents that they have consistently adhered to all pertinent statutory and regulatory requirements.
3. Dealing with Inadvertent DEA Compliance Failures
Inadvertent compliance failures are not uncommon. Everyone makes mistakes, and the DEA will allow a certain amount of grace when warranted by the circumstances. But, mitigating the consequences of inadvertent compliance failures requires a strategic approach informed by extensive experience on both sides of DEA inquiries.
4. Dealing with Personnel Issues
Healthcare providers and pharmacies can also encounter issues during DEA audits if their personnel have disregarded the importance of compliance. Rogue employees are among healthcare providers’ and pharmacies’ greatest risks, and handling situations involving individual employees who have substantially deviated from their compliance programs requires a highly tactical approach.
5. Facing Administrative Penalties (or a Civil or Criminal Referral) Unnecessarily
These risks, among many others, can result in healthcare providers and pharmacies facing administrative penalties (or referrals for civil enforcement action or criminal prosecution) unnecessarily. At Corporate Investigation Consulting, our former agents and investigators rely on centuries of relevant experience to help defend our clients to the fullest extent possible.
5 Keys to Successful DEA Audit Defense
Taking these risks into account, presenting a successful defense during a DEA audit is paramount. Here are five of the key steps we take to help protect our clients:
1. Immediate and Comprehensive DEA Compliance Assessment
When a healthcare provider or pharmacy engages our team for DEA audit defense, we work quickly to conduct a comprehensive DEA compliance assessment. Once we know what we’re working with, we can then tailor our subsequent efforts accordingly.
2. DEA Audit Defense Strategy Formulation
Based on what we learn during our compliance assessment, we will formulate an audit defense strategy that is custom-tailored to the facts at hand. Demonstrating compliance and dealing with instances of non-compliance are two very different scenarios, and each requires a very different approach.
3. DEA Audit Intervention and Defense Execution
When facing a DEA audit, early intervention is key. Our former agents will intervene in the audit promptly, open a constructive dialogue with the DEA’s auditors, and begin executing our defense strategy.
4. Proactive Involvement Throughout the DEA Audit Process
It is important for healthcare providers and pharmacies to play a proactive role throughout the DEA audit process. At Corporate Investigation Consulting, we deal with the DEA every step of the way, and we continuously work to steer our clients’ audits toward favorable resolutions.
5. Targeting a Specific Positive Outcome
When executing a defense strategy, it is important to have a specific positive outcome in mind. Whether this involves avoiding liability entirely (as is often the case) or mitigating the consequences of compliance failures, targeting a specific result allows providers and pharmacies to take control of the process.
FAQs: DEA Audit Defense
What Can I Expect from a DEA Audit?
During a DEA audit, you can expect DEA agents to closely scrutinize all aspects of your practice’s or pharmacy’s prescription drug compliance program. This includes everything from ordering and storage to dispensing and disposal. If DEA agents uncover any compliance failures, this can lead to administrative penalties or other consequences.
How Do I Prepare for a DEA Audit?
To prepare for their DEA audits, healthcare providers and pharmacies should engage an outside consulting firm promptly. The first priority is to conduct a DEA compliance assessment in order to determine what risks the audit presents. Based on the results of this assessment, the consulting firm can then structure a defense accordingly.
What Issues Can Lead to Problems During a DEA Audit?
Numerous issues can lead to problems during a DEA audit. This includes various types of compliance failures as well as failing to maintain adequate documentation of compliance. Incomplete records, missing inventory, and suspect prescription or dispensing practices are just a few examples of issues that can have serious consequences.
What Are the Consequences of Failing to Maintain DEA Compliance?
The consequences of failing to maintain DEA compliance depend on the nature and extent of the failure. In many cases, non-compliance will lead to suspension or revocation of a provider’s or pharmacy’s DEA license. But civil penalties and criminal prosecution are very real risks as well.
Do I Need to Engage a Consulting Firm for a DEA Audit?
Due to the risks involved with facing a DEA audit, it is strongly in healthcare providers’ and pharmacies’ best interests to engage an outside consulting firm for their defense. At Corporate Investigation Consulting, we bring centuries of relevant experience to the table, and we have a proven track record of helping our clients resolve DEA audits without unnecessary consequences.
Speak with a Former DEA Agent or Investigator in Confidence
If you would like to speak with a former DEA agent or investigator at Corporate Investigation Consulting, we invite you to get in touch. To schedule a confidential initial consultation as soon as possible, please call 866-352-9324 or tell us how we can reach you online today.