Anyone who prescribes, administers, or dispenses controlled substances must be registered with the DEA. This includes manufacturers as well as doctors, hospitals and pharmacies.
The DEA is responsible for keeping track of what controlled substances are ordered and dispensed through its ARCOS database – an automated, drug reporting system that monitors the flow of controlled substances from manufacturing through commercial distribution channels to point of sale or distribution, i.e. practitioners, pharmacies, etc.
In most instances, these are legitimate businesses operating within the law. Regardless, anyone with a DEA registration is fair game for an inspection from the DEA. This can occur either through a planned inspection or a surprise visit.
Before initiating an investigation, the DEA investigator who comes knocking at your door first must present a Form 82 – Notice of Inspection – a type of informed consent. What most don’t realize is that they may withhold consent by refusing to sign, or withdraw consent at any time during the inspection if they feel things are not going well. By doing so, the DEA must leave and return with an administrative inspection warrant or a search warrant from a federal magistrate.
There may be many reasons a DEA registrant may not want an inspection that are perfectly legitimate. Perhaps it’s simply because he or she is taking care of patients and can’t take time out of their schedule. Or, perhaps the registrant wants to get their paperwork in proper order prior to an inspection.
Should you concede to the inspection, there are some things DEA investigators can do and some they can’t. Basically, the DEA is authorized by law to “inspect, copy, and verify the correctness of records required to be kept” under the code of federal regulations. They are not permitted to review financial data, sales or pricing data, personal records or patient charts.
Some clients have been told if they don’t sign the consent form they will be arrested. That’s simply not true. The form clearly states that you have the right to refuse to consent and not have the inspection take place without a warrant.
Refusing to comply doesn’t mean an inspection will not take place, but it will give you time to reach out to legal counsel and get advice. Often legal counsel can find out more about the reason behind the inspection (i.e. Was it prompted by a complaint?) This can help in finding ways to mitigate the problem and even work with the agency to find a resolution.
Why is this important? If DEA investigators find something untoward, even if it’s an innocent mistake, they can bring administrative, civil and/or criminal charges against the registrant. This can result in the revocation of a registration, civil penalties and/or criminal prosecution.
And it doesn’t end there. The loss of a DEA registration, whether voluntarily, temporary or permanent, will be reported to the National Practitioner Data Base and often is reported to state licensing agencies and PBM databases. That, in turn can result in having action taken against your medical license, a revocation of Medicare or Medicaid licensure or the loss of credentials.
The bottom line is that any inspection – routine or otherwise – must be taken seriously. When the DEA comes knocking your first call should be to counsel experienced in DEA matters.