By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
As the United States continues to open back up from the COVID-19 shutdown, the Drug Enforcement Agency (DEA) is resuming on-site routine inspections. Therefore, healthcare professionals must ensure compliance and regulatory efforts are in place.
This is part 1 of a 2-part blog series. Check back for part 2 of this blog series soon!
DEA Inspections and Site Visits: Subpoenas.
DEA agents are often pushy, demanding, and intimidating. They will try to use subpoenas (which are merely requests for documents that afford you at least ten days to produce the requested documents) as search warrants. THEY ARE NOT. They will try to use an administrative subpoena to obtain documents and get your testimony immediately. YOU DO NOT HAVE TO PRODUCE THEM RIGHT AWAY. A copy of a sample subpoena used by the DEA is on our website for reference here.
Not Just a Routine Audit, Inspection, or Investigation.
Beware the “Notice of Inspection of Controlled Premises” (DEA Form 82). Although the DEA often treats it as one, it is not a search warrant. Also, it is probably NOT a “Routine Inspection.” IT WILL NOT TAKE ONLY 15 TO 20 MINUTES.
We have had several clients who have had to close down their businesses all day to try to accommodate the demands of the agents performing their “routine inspection.” The DEA should not cause you to shut down or should not cause you to turn away patients. It should not interfere with your patient services or your ability to provide them. You can ask them to come back at a later date.
The DEA often refers to “routine audits” as “Accountability Investigations” and requires the pharmacy or registrant to be given certain rights in connection with it. For example, DEA Form 82 states you are given the following rights:
1. The constitutional right not to have an administrative inspection without an Administrative Inspection Warrant (AIW),
2. Has the right to refuse consent to such an inspection,
3. Presented with a Notice of Inspection,
4. Given consent voluntarily, without threats of any kind,
5. May withdraw consent at any time during the course of the inspection, and
6. Incriminating evidence may be seized and used in criminal prosecution.
Although the DEA agent may tell you that the site visit is “completely random,” do not believe it. If the DEA agent has brought a list of records to obtain from you, try to keep a copy of it, as your lawyer may find it very useful later when they are defending you.
What to Do When Confronted with a DEA Inspection or Site Visit.
1. Notify the owner right away. If you are not the owner, don’t sign anything, give permission, or agree to anything. You probably have no authority to do so.
2. Call your health lawyer and get them over immediately. This is an emergency!
3. Yes, you have the right to consult with your attorney; do not believe them if they say you can’t (which they may do, believe it or not).
4. Request photo identification from everyone to ensure the individuals are who they say they are. No identification? No access. Federal agents, including DEA agents, will always have their photo ID.
5. Obtain a business card from each person present. DEA agents always carry business cards. If they do not have one, you will have to write all contact information for that agent from their photo id card (or photocopy, if they will allow you to do so).
6. Do the same as the above for anyone else the DEA brings, whether they claim to be a federal or state investigator, Department of Health investigator, or local police. Please note that our experience has been that the DEA and state agencies contend that they don’t go on joint inspections or investigations (however, we don’t believe this to be true). Therefore, get all parties’ information at the very start, or you may never get it until they testify against you.
7. DO NOT SIGN A VOLUNTARY AGREEMENT TO RELINQUISH YOUR DEA REGISTRATION. Agents may try to pressure and intimidate you into signing one by telling you it will be easier if you sign it. They might even try to scare you by warnings of criminal prosecution unless you sign it. Yes, you have the right to consult with an attorney before deciding whether or not to sign it (they may falsely tell you that you don’t). However, once you sign it, it is gone. If you are a prescribing physician or health professional, your authority to prescribe is gone forever. If you are a pharmacy/pharmacist, your ability to order or fill any controlled substances is forever gone. So go ahead and put a sign on the door that says “CLOSED-Out of Business.”
8. Before the inspection begins, you should be given a form to read and sign. If not, request it. It will usually be a DEA Form 82 “Notice of Inspection of Controlled Premises” Form. Before the inspection, it should be read, explained, agreed to, and signed, not during or after.
9. Read the form carefully. You have the right to fax it, scan and e-mail it, or call and read it to your attorney before you sign it. If it says you have the right to refuse the inspection, consider putting it off until a later date. Especially if you are busy and have patients you must serve.
10. Obtain a copy of the form (inspection form or subpoena) at the beginning and keep it. You will need this later.
11. Obtain a complete, detailed receipt for any documents, prescriptions, or other items taken by the agents. Again, since this is not a search warrant, the DEA does not have the authority to take your only originals and leave you without a copy.
12. You may or may not be in serious trouble and subject to future criminal charges or administrative action to revoke your DEA registration. Your attorney should be able to evaluate this and advise you. Don’t bother to ask the agents, as they will not tell you what is in your own best interest to know.
13. If you don’t have an attorney who is experienced in health law and DEA defense, get one NOW. You should begin preparing now. It often takes the DEA a year or more to work up charges against you. Once you are served with charges, you will only have a very short time to prepare your defense. It is a completely unfair system for the subject of charges as the government will have longer to prepare its case against you than you have to prepare your defense. Take advantage of the time you have. Do not waste it.
14. Be polite and do not argue with a DEA agent.
15. Do not volunteer information, but never tell a lie. Making a false statement to any federal agent is a felony criminal offense. A subpoena for documents is not an authorization to interrogate you. A search warrant is not an authorization to interrogate you.
Lastly, don’t forget to check back to read part 2 of this blog series.
Please remember: This blog’s statements are opinions based on our experience. If you do not agree with it, then you are probably the DEA.
Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.
The attorneys of The Health Law Firm provide legal representation to physicians, pharmacists, pharmacies, medical groups, nurses, nurse practitioners, CRNAs, dentists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.
To contact The Health Law Firm, please call (407) 331-6620 or (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.
About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.
Current Open Positions with The Health Law Firm. The Health Law Firm always seeks qualified individuals interested in health law. Its main office is in the Orlando, Florida, area. If you are a current member of The Florida Bar or a qualified professional who is interested, please forward a cover letter and resume to: PAlexander@TheHealthLawFirm.com or fax them to (407) 331-3030.
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