The Drug Enforcement Administration’s (“DEA”) mission is, in part, to enforce the controlled substances laws and regulations of the United States. Among its responsibilities, the DEA audits medical providers for compliance with the Controlled Substances Act, particularly provisions regarding distribution and dispensing of legally produced controlled substances. It is important for medical providers to be proactive and continuously prepared for DEA audits.
Generally, DEA Diversion Investigators will arrive, unannounced, for an audit at a physician’s office. Federal law requires Diversion Investigators to state the purpose for the visit. The physician will be asked to voluntarily consent to the audit. The physician is not required to consent and should contact legal counsel to determine whether consenting is the right course of action. If there is no consent, the DEA must apply to a federal district court to obtain an administrative inspection warrant. Diversion Investigators are authorized to inspect, copy, and verify the correctness of records required to be kept pursuant to federal law.
Audits must be conducted at reasonable times and in a reasonable manner. Depending on the circumstances, it may be appropriate to request that the DEA come at another time when the physician will either voluntarily consent or request that the DEA obtain an administrative investigation warrant. A few examples of circumstances that may warrant this action include: absence of physician, patient scheduling issues, and/or the desire of the physician to have legal counsel present. In any event, it is important to attempt to establish a good relationship with the Diversion Investigators beginning with the first contact. In addition to maintaining policies regarding tracking controlled substances at a physician’s facilities, best practices include preparing a policy outlining audit response actions, i.e., designate one employee to communicate with Diversion Investigators, outline actions of that employee and other employees when Diversion Investigators arrive, including when to contact legal counsel.
Note that this post is only a brief summary of the DEA and its audit procedures. It does not constitute legal advice nor does it establish an attorney/client relationship. Should you have specific questions regarding the above, please contact Earle F. Hites or Preston G. Sisler at Hodges and Davis.
Hodges and Davis, P.C. – March 2016