Understanding DEA Audits and Investigations
The Drug Enforcement Administration (DEA) is responsible for enforcing the controlled substances laws and regulations of the United States. Healthcare providers, pharmacies, and other entities that handle controlled substances are subject to DEA oversight, which can include audits and investigations.
DEA Audits
DEA audits are routine inspections conducted to ensure compliance with federal regulations regarding the handling, prescribing, and dispensing of controlled substances. These audits can be scheduled or unannounced and are a normal part of operating as a DEA registrant.
What triggers a DEA audit?
While DEA audits can be random, certain factors may increase the likelihood of an audit. These include discrepancies in inventory records, unusually high volumes of controlled substance prescriptions, reports of theft or loss, and complaints from patients or other healthcare professionals. The DEA may also conduct an audit if there is suspicion of non-compliance or diversion of controlled substances.
DEA Investigations
DEA investigations are more serious than routine audits and typically occur when there is evidence or suspicion of criminal activity, such as diversion of controlled substances, prescription fraud, or illegal distribution. Investigations can involve surveillance, interviews, and collaboration with other law enforcement agencies.
What to expect from a DEA investigation?
If you are the subject of a DEA investigation, you can expect a thorough review of your prescribing and dispensing practices, as well as your recordkeeping and inventory management. Investigators may interview staff, review security measures, and analyze prescription data. The process can be lengthy and may result in administrative, civil, or criminal penalties if violations are found.
How do I know if the DEA is investigating me?
In some cases, individuals may not be aware they are under investigation until they are contacted by DEA agents or receive a subpoena. Signs that you may be under investigation include requests for records, interviews with staff or patients, or notification from your legal counsel. It is important to consult with an attorney if you suspect you are being investigated.
DEA Red Flags
The DEA monitors for "red flags" that may indicate improper prescribing or dispensing of controlled substances. These can include patterns such as multiple patients receiving the same prescriptions, prescriptions for unusually high doses, or frequent early refill requests.
What does it mean to be flagged by the DEA?
Being flagged by the DEA means that your prescribing or dispensing practices have triggered one or more red flags, prompting closer scrutiny. This does not necessarily mean you have committed a violation, but it may lead to an audit or investigation to determine if there is any wrongdoing.
Conclusion
DEA audits and investigations are important tools for ensuring the safe and legal use of controlled substances. By maintaining accurate records, following best practices, and staying informed about regulations, healthcare providers can minimize their risk of DEA scrutiny.
