The Drug Enforcement Administration (DEA) frequently conducts audits and inspections of prescribers, dispensers and wholesalers. 

Are you ready?  

Thankfully, our team of compliance professionals includes experienced audits and investigators who have handled hundreds of controlled substance inspections can help you!

What does the DEA audit or inspect during an audit? 

DEA diversion investigators are responsible for combing the nation’s physicians, pharmacists, and controlled substance distributors inspecting for compliance with the controlled substances act 21 U.S.C. 801 et. seq. The DEA typically investigates the following areas: 

• Controlled substance storage 
• Recordkeeping 
• Provider documentation 
• Mid-level delegation 
• Security of controlled substances 
• Dispensing records 

They typically show up unannounced and seek permission to inspect your practice by issuing a notice of inspection. Many practices, that don’t have a government contact policy are ill equipped for this visit and let the DEA roam their practice often looking in impermissible areas. DEA registrants such as physicians and pharmacists don’t know that they can ask the DEA to return at a later date. 

Once inside, the DEA is sure to conduct a complete audit and generally find non-compliance in just about any practice they inspect. Unless the practice has done a pre-inspection utilizing CCG Healthcare’s compliance team, that is. 

Providers who have engaged in a compliance program and mock inspections proceed through the DEA audit and inspection process with peace of mind and confidence. Those ill prepared will generally be fearful of DEA action against their registration or even potential criminal indictment. 

What action can the DEA take when it finds non-compliance? 

If the DEA finds areas of non-compliance it can take administrative action such as revoking a DEA registration, civil action which includes a suit for monetary damages for each violation, or even criminal action which could include an indictment for violation of the controlled substances act. Potential sanctions include: 

• A DEA memorandum of agreement restricting prescribing and dispensing 
• DEA order to show cause proceedings 
• Suspension or revocation of a DEA registration
• Civil monetary penalties 
• A federal injunction prohibiting prescribing and dispensing 
• Criminal indictment 
• Forfeiture of property 
• Entry in to the National Practitioner’s Databank

What are the most common areas of DEA non-compliance? 

• Failure to properly store controlled substance records 
• Poor provider documentation 
• Pre-signing blank prescription pads 
• Improper mid-level delegation 
• Improper storage of controlled substances 
• Exceeding DATA 2000 buprenorphine patient load 
• Poor drug counts 

For those concerned about a DEA audit or investigation – there’s hope. The Department of Justice 2020 Manual discussing corporate compliance program clearly states that entities who engage in regular auditing or monitoring get the benefit of the doubt. 

That’s where we come into play. We can do it for you. 

By conducting pre-inspections utilizing qualified a qualified compliance firm such as CCG Healthcare you can show the DOJ and DEA that you are serious about compliance. Without a compliance program issues such as theft, loss, poor documentation, or employee misconduct can put a target on the back of the company or the owner. But, when a healthcare company has a robust compliance plan complete with mock DEA audits, inspections, and policies and procedures along with staff training – the DOJ gives the provider the benefit of the doubt. 

DOJ audits and inspections can also be frightening for the staff. The appearance of the DEA can deeply impact morale. This is why during our mock DEA audits and inspections we train staff to expect routine audits and inspections and train them exactly how to smoothly handle a DEA audit or investigation to ensure that the company puts the right foot forward in cooperation and compliance. 

Who is at a higher risk of an audit or inspection? 

The DEA is getting more and more sophisticated and utilizes data mining to determine targets of investigation. Given the rapid multi-state implementation of PDMP programs nationally, the DEA can subpoena and review PDMP data to determine who is a high prescriber or dispenser. The DEA has been systematically investigating and shutting down pharmacies and physicians who deviate significantly from their peers. The DEA also can review Medicare Part D dispensing data to determine prescribing practices. 

Independent pharmacies are also a hot target for the DEA. Pharmacies like Walgreens, CVS and other large chains have already been under corporate integrity agreements and have routine auditing and monitoring programs. Small chain and independent pharmacies generally have not invested significantly in compliance. This is a massive compliance risk in such a highly regulated industry. 

Buprenorphine and MAT prescribers are also no stranger to frequent DEA audits, inspections, and even indictments. Those prescribing and dispensing medication assisted treatment drugs are five times more likely to be audited. 

How can CCG Healthcare help you gain compliance? 

Our compliance investigators do a front door to back door inspection of your pharmacy or practice. We know the areas that the DEA will inspect and we hunt for areas of non-compliance so that you can work out issues before the DEA comes knocking. We will conduct staff training, implement policies and procedures, audit charts, review controlled substance storage and recordkeeping issues. We also go far beyond DEA compliance and can analyze billing and coding, HIPAA privacy issues, and other issues frequently targeted by state and federal agencies. 

When you call us for a free practice review we can discuss your compliance program and learn your needs to determine if an audit, inspection, or compliance program is necessary for your practice.