The DEA’s “legitimate medical purpose” standard – Part I

Posted on October 4, 2015 by - DEA Prosecutions, Licensure

Committing prescription drug crimes with your DEA “License”

Many physicians, all pharmacies, and some nurses, have DEA “Registrations.” Practitioners will often refer to their DEA Registration as a “license,” or simply, “my DEA.” The DEA Registration grants “authority” to the Registrant under the Controlled Substances Act (CSA) to possess, prescribe, and/or dispense controlled substances, to the extent authorized by the Registration.

If you possess a DEA Registration, you play an integral part in controlling the Nation’s drug supply, a “closed system” of inventory wherein every controlled drug is tracked from the point of manufacture to the end consumer, a patient. As such, DEA Registrants are subject to much scrutiny under the CSA, a complex legal scheme that keeps our federal trial and appellate courts quite busy.

A civil or criminal investigation – which is it?

When DEA lawyers and agents investigate physicians, pharmacists and nurses under the CSA, they may pursue the DEA Registrant civilly or criminally. The DEA has a choice. When the DEA pursues a Registrant civilly, the process can feel similar to a licensure proceeding before a state licensing board. When, however, the DEA pursues a Registrant criminally – for prescription drug crimes – it will feel like a criminal prosecution, with the full weight of the government bearing down.

Are the lines blurred between the civil and criminal standards?

I have successfully argued that DEA attorneys and agents, while fulfilling their responsibilities to “police” both civil and criminal violations of the CSA, have blurred the line between civil violations (the standard of care) and criminal violations involving prescription drug crimes (i.e., unlawful prescribing, unlawful dispensing, drug diversion, or prescribing without a legitimate medical purpose), thereby “criminalizing” what would otherwise be, at best, a civil violation, see US v. Chube II, 538 F3d 693 (7th Cir. 2008), or no violation at all. See Gonzales v. Oregon, 546 U.S. 243, 126 S. Ct. 904, 163 L. Ed. 2d 748 (2006).

Application of the legitimate medical purpose standard in civil and criminal proceedings

If, while pursuing civil violations, the DEA’s attorneys and agents investigate a doctor for prescribing without a legitimate medical purpose, and they equate a legitimate medical purpose with the civil standard of care, I am not sure what difference it makes. This is because on the “civil side” of the DEA, the DEA will enforce the standard of care, much like a state licensing board. If the DEA wants to call it by another name – i.e., legitimate medical purpose – I do not see how it matters, as the out come will likely be the same.

If, however, the DEA attorneys and agents are investigating a doctor for a prescription drug crime, and the DEA equates “prescribing without a legitimate medical purpose” with the civil standard of care, then we have a problem – the doctor’s “criminal” conduct will now be measured against the civil negligence standard, a lower legal standard, making it easier for the government to prove wrong doing. This is a trap for pharmacists too, because the so-called “legitimate medical purpose” rule states that “a corresponding responsibility rests with the pharmacist who fills the prescription.” See 21 CFR ยง1306.04(a) (legitimate medical purpose rule). Thus, whether you are a prescribing physician or a dispensing pharmacist, never forget that a violation of the civil standard of care when prescribing or dispensing controlled drugs is professional negligence, or malpractice; it should not be, without more, viewed as an intentional drug crime, which requires more proof, i.e., proof of intentional wrong doing.

Further discussion on this subject

In a subsequent post, I will shed light on one of the ways DEA attorneys and agents have accomplished this blurring of the lines, which, in my experience, “waters down” the burden of proof required to convict physicians and pharmacists of prescription drug crimes, and also makes it easier to find the “relevant conduct” necessary to lengthen a prison sentence under the federal sentencing guidelines.