We continue with our series of general educational articles penned by one attorney, an MD, JD, giving you a view of the world through a malpractice plaintiff attorney’s eyes. This attorney is a seasoned veteran.  The series includes a number of pearls on how to stay out of harm’s way. While I do not necessarily agree with 100% of the details of every article, I think the messages are salient, on target, and fully relevant.  Please give us your feedback – and let us know if you find the series helpful. Finally, these articles are not intended as specific legal advice. For that, please consult with attorney licensed to practice in your state.

“Doctor, there is a DEA agent at the front desk. He wants to speak with you.”

What now?

Under the Controlled Substances Act (21 U.S.C. §§ 801-971) and the regulations at 21 CFR 1300-1321 the DEA is not just authorized but mandated to monitor controlled substances. Its Diversion Control program is specifically addressed “to prevent, detect, and investigate the diversion of controlled pharmaceuticals and listed chemicals from legitimate sources” – in other words, from offices like yours – and so is empowered to perform an unannounced site inspection.

However, that does not mean that these visitors – more likely Diversion Investigators than actual agents – can have immediate unfettered access to your office. Knowing your own rights is the most effective way to avoid being pulled into a more serious problem.

To begin with, they need your consent to continue. They will present a Notice of Inspection of Controlled Premises (Form 82) and ask you to sign it, giving that consent. However, that form specifically notes that what is found may be used against you in civil or criminal proceedings and that you have the right to refuse.

If you refuse they must get an administrative inspection warrant. They will probably, just as in every Law and Order episode, voice that as a threat of an immediate and inevitable return – “If you don’t sign now we will come back with a warrant” – but the fact is that while a request for such a warrant will likely be granted that process will take days to weeks, allowing you to consult in detail with an attorney and to take the next protective steps that we will discuss below.

There is also a third option, a middle ground between making them more aggressive (because you refused) and just allowing them to plough through your records and question your staff without any preparation: Call your lawyer immediately and discuss whether this is the “right day” for them to inspect you. After all, you are a good citizen with nothing to hide and certainly intend to cooperate, but you have patients and this will be disruptive of their care and of staff availability.

Put the lawyer on the phone with the inspector. He or she will be able to establish that you absolutely respect the importance of their mission to prevent drug diversion but that you cannot simply close down immediately to permit the inspection to go forward at that specific time. The attorney will probably also be able to get a sense of whether this is a random inspection or whether a complaint was made, which will allow them to advise you better. If you cannot reach your lawyer you can try to reschedule on your own.

If your lawyer / you are not able to agree with the DEA on a mutually convenient day then you should, unless specifically instructed by your lawyer to consent, refuse and wait for the warrant so that you will now have time to confer with your lawyer and perhaps even arrange to have counsel present at the inspection.

When the actual inspection occurs it cannot be a fishing expedition. In that regard, there are two important limitations to bear in mind:

(i) The DEA is only authorized to “inspect, copy, and verify the correctness of records required to be kept.” What this means is that it is allowed to look at your records on controlled substances to determine if they comply with the regulations that you are under as a practitioner who prescribes such and whether there is evidence of diversion – and that’s it.

(ii) While there will necessarily be conversation between you and your staff and the inspector, DEA inspectors are not permitted to interrogate.

Both of these are very good reasons to prepare, to set up the proper person to deal with the inspector (most likely you or your office manager) and to make sure that that person will keep the inspection on its limited track and engage only in communication that is courteous but kept to a bare minimum.

The inspector may, at the end of the inspection, present a Voluntary Surrender of Controlled Substances Privileges (Form 104) under which you would give up your registration to avoid the DEA proceeding further. Since this form becomes effective as soon as a DEA employee receives it, signing it would immediately trigger loss of the ability to prescribe controlled substances, potential disciplinary action by the state medical board and a potential loss of credentials. Since it generally takes 18 months to 2 years to reacquire registration – if at all, since the DEA will oppose this with an Order To Show Cause – signing this under the stress of the inspection because you think that you are thereby ending the problem is something that you definitely should not do on your own. The ramifications are serious and this is a matter you want to discuss with counsel.

If your lawyer is not present at the inspection then as soon as the inspector leaves write a memo for him or her describing everything that was said and done during the inspection. This will be fully privileged as an attorney-client communication so be honest. If your attorney needs guidance from a compliance expert they should hire that individual themselves so that any communications with them will be shielded as work product. Before we continue, a brief reminder: Medical Justice is equipped to help doctors address a bevy of medico-legal threats – including unexpected visits from the DEA. Use the tool below to schedule a free consultation with our Founder and CEO, Jeff Segal, MD, JD. With that said, the article continues below.

If the inspection turns up a problem and a voluntary surrender was either not deemed warranted or was refused then the matter moves to the next phase, which can, depending on the severity of the infraction and any history of prior misconduct, range up to a criminal investigation by actual DEA Special Agents or by the U.S. Attorney’s Office.

Most deficiencies, though, will only trigger administrative remedies…but “only” is a relative term because administrative proceedings can still have a significant impact on a practice by restricting the ability to prescribe and can begin a penumbra of events including disciplinary actions and a loss of credentials. They should not be taken lightly.

The lowest level of sanction is a private (i.e.; between the DEA and you) Letter of Admonition (LOA). This is a warning on the record. You are not required to report it but it will be taken into account by the DEA should there be future violations.

The next level is a private Memorandum of Agreement (MOA) negotiated by your attorney and the DEA under which you agree to undertake measures for a limited time to address the specific deficiencies that were found and also agree to be re-inspected without a warrant but “within reason and so as not to unduly disrupt the practice.” The caveat, though, is that even after an MOA expires it will, like an LOA, be a basis to enhance sanctions if there is a future violation. The critical issue for you in agreeing to an MOA is that it be narrowly tailored so as to not unduly disrupt your practice or your ability to remain credentialed at your hospital or group.

If greater administrative sanctions are deemed warranted the next step is for the DEA to issue an Order To Show Cause why your registration should not be revoked or suspended. The case will then be heard by a U.S. Administrative Law Judge who will determine if letting you continue to prescribe controlled substances is “inconsistent with the public interest.” The ALJ will not personally act on your registration but will issue a Recommended Opinion that will be forwarded to the DEA Administrator. A critical point here is that that Opinion is not binding and so the Administrator may accept it or reject it or modify it, including more harshly. The results are then published on the DEA website under “Diversion Control and Prescription Drugs/Cases Against Doctors.”

The best prevention of any of these outcomes is, of course, compliance. There is a Compliance Manual on the DEA website and it should be referred to when there is a question. The office should also, as it does for HIPAA, have an assigned Compliance Officer on controlled substances prescribing and that person should also be the designated contact in an inspection.

In summary: A site inspection by the DEA is going to be a very upsetting event and so it is essential to understand the limited authorization of the inspector, the rights of the doctor and the steps in the process and to act only after due consideration and on advice of counsel.

Medical Justice provides free consultations to doctors facing medico-legal obstacles. We have solutions for doctor-patient conflicts, unwarranted demands for refunds, online defamation (patient review mischief), meritless litigation, and a gazillion other issues. We also provide counsel specific to COVID-19. If you are navigating a medico-legal obstacle, visit our booking page to schedule a free consultation – or use the tool shared below.

Learn how Medical Justice can protect you from medico-legal mayhem… 

Jeffrey Segal, MD, JD

Chief Executive Officer and Founder

Dr. Jeffrey Segal, Chief Executive Officer and Founder of Medical Justice, is a board-certified neurosurgeon. Dr. Segal is a Fellow of the American College of Surgeons; the American College of Legal Medicine; and the American Association of Neurological Surgeons. He is also a member of the North American Spine Society. In the process of conceiving, funding, developing, and growing Medical Justice, Dr. Segal has established himself as one of the country’s leading authorities on medical malpractice issues, counterclaims, and internet-based assaults on reputation.

Dr. Segal was a practicing neurosurgeon for approximately ten years, during which time he also played an active role as a participant on various state-sanctioned medical review panels designed to decrease the incidence of meritless medical malpractice cases.

Dr. Segal holds a M.D. from Baylor College of Medicine, where he also completed a neurosurgical residency. Dr. Segal served as a Spinal Surgery Fellow at The University of South Florida Medical School. He is a member of Phi Beta Kappa as well as the AOA Medical Honor Society. Dr. Segal received his B.A. from the University of Texas and graduated with a J.D. from Concord Law School with highest honors.

In 2000, he co-founded and served as CEO of DarPharma, Inc, a biotechnology company in Chapel Hill, NC, focused on the discovery and development of first-of-class pharmaceuticals for neuropsychiatric disorders.

Dr. Segal is also a partner at Byrd Adatto, a national business and health care law firm. Byrd Adatto was selected as a Best Law Firm in the 2021 edition of the “Best Law Firms” list by U.S. News – Best Lawyers. With over 50 combined years of experience in serving doctors, dentists, and other providers, Byrd Adatto has a national pedigree to address most legal issues that arise in the business and practice of medicine.