Your Office Manager comes into your office and tells you there are two DEA agents in the waiting area who want to inspect your office and ask you some questions. You go out to meet them, they briefly present official credentials and tell you they wish to conduct an audit or administrative inspection. You inform them that you have patient hours that day and ask them what gives them the right to come in and disrupt your practice without warning. They answer that since you have a DEA Registration they have a right to inspect and “today is your lucky day.” They then hand you a form that states if they uncover any evidence of criminality during the “administrative inspection” it can be used against you in a criminal prosecution. The form also states that you have a right to refuse the inspection. You ask about that and they tell you if you refuse the inspection they will “come right back with a warrant.” Confused, and perhaps a bit panicked, you decide this is as good a day as any to have the inspection and you let them in. During the inspection you and your staff also engage them in conversation and answer their questions regarding your administering, dispensing, prescribing and record keeping regarding controlled substances. They notice a non-formulary drug on your inventory and learn that it was ordered for the child of one of your employees. You call counsel later, more as an afterthought and seeking reassurance that all will be OK, and state to counsel that certainly this cooperation and transparency will put you in a good light? This article will explain why this was a poor choice.
This scenario is played out daily in this day of increased health care scrutiny. The DEA representatives most likely were DEA Diversion Investigators (DIs), as opposed to DEA Agents. Their stepped-up efforts are a result, and part, of DEA’s Diversion Control Program. This special mission of DEA in carrying out the program “is to prevent, detect, and investigate the diversion of controlled pharmaceuticals and listed chemicals from legitimate sources while ensuring an adequate and uninterrupted supply for legitimate medical, commercial, and scientific needs.” This is premised on the realization that a substantial increase in the number of substance abuse problems are the result of legitimate controlled substances being abused by patients or being diverted to the illicit drug market.
The DEA derives its authority to pursue its Diversion Control program from federal law. Specifically the Controlled Substances Act (CSA), 21 U.S.C. §§ 801-971, and the corresponding regulations found at 21 CFR Part 1300-1321, give DEA the authority and responsibility to monitor and regulate pharmaceutical controlled substances. These same laws and regulations also set forth the requirements of physicians and other health care providers who have authority to prescribe, dispense and/or administer controlled substances.
The controlled substances are divided into five schedules and are found at 21 C.F.R. 1308.11 through 1308.15. The different schedules and the placement of a controlled substance within a schedule is based on whether the controlled substance has a currently accepted medical use in treatment in the United States and on its potential for abuse and causing of dependence.
So is everything the DIs told the physician (provider) in the scenario above true? Yes, substantially correct. First, under the CSA and corresponding regulations, DEA has the right to conduct administrative inspections or audits. They prefer to show up unscheduled and unannounced and to obtain the provider’s consent to search. They will provide a DEA Form 82, entitled Notice of Inspection of Controlled Premises, and will ask the provider to consent by signing the form. As the form makes clear, the provider has a right to refuse t