Two doctors were indicted earlier this year and accused of illegally administering ketamine to patients and fraudulently billing Medicare for certain services related to a psychiatric clinic.

Do you store and administer controlled substances at your facility? Have you audited your controlled substance processes to ensure full compliance with state and DEA requirements?

Storage and administration of controlled substances is a highly regulated practice that must be done in accordance with strict state and federal laws. When facilities fail to follow the requirements, it can lead to heavy fines and potential jail time. In this case, each of the doctors was indicted on 22 felony counts.

Among the issues encountered by the DEA was one physician administering drugs at a clinic he was not licensed at. The second doctor did not have a DEA license and was administering controlled substances without the direct supervision of the licensed doctor and at a location (the clinic) that was not licensed for controlled substances.

The licensing laws are very specific about what steps must be taken for a practitioner to administer and a clinic to store controlled substances. This is a complicated case and licensing is only one of many issues. To put it in perspective, the illegal distribution of a controlled substance charge alone carries a penalty of up to 10 years in prison, a fine of $500,000 or both.

What are you doing to ensure this will not happen in your facility? Earlier this year, I shared with each of our clients a check list for a potential DEA inspection. During my facility visits, I discussed the steps that must be taken to maintain compliance and shared the necessary tools to accomplish it. Here are some questions you must ask yourself while assessing your facility readiness:

1. Do you have all your documents in a central location and easily accessible?
2. Do you have your DEA and state (if applicable) licenses up to date?
3. Can you provide a list of all employees who have access to controlled substances?
4. Do you have a copy of your facility alarm contract?
5. Do you have a copy of your facility floor plan?
6. Do you have all your controlled substance invoices stored according to federal law?
7. Do you have the measurements of your controlled substance storage cabinets?
8. Do you have completed biennial inventories.
9. Do you have clear dispensing records?

This is not an exhaustive list of items that must be present during a DEA facility inspection, but it covers many of the important requirements. If you’ve got all these items easily accessible, you’re on your way to a successful audit. On the other hand, if any of the above items are missing, now is the best time to get working on tightening up your controlled substance documents.

If you have questions on any of these requirements or would like us to fully assess your controlled substance program, you can contact us,