What Should I Do if the DEA is Investigating My Ketamine Prescription Practices?

Unlawful Distribution of Ketamine

As noted above, the FDA has only approved ketamine for use as a general anesthetic. However, the FDA’s approval of ketamine for use as a general anesthetic does not prohibit doctors from prescribing it for off-label use. In fact, doctors routinely prescribe medications for off-label use. However, in order to prescribe ketamine (or other drugs) for off-label use, doctors must still comply with all other federal laws and regulations that apply to their practices.

For example, under the CSA, ketamine is considered a Schedule III controlled substance. This means that it has “a moderate to low potential for physical and psychological dependence.” To schedule a substance under one of the CSA’s five schedules, the DEA considers the drug’s “potential for abuse,” among other factors. In this particular case, the DEA determined that ketamine’s potential for abuse warranted its classification as a Schedule III controlled substance.

As a result, while prescribing ketamine for off-label use is not illegal, it is subject to strict limits under the CSA. This is true for both physicians who prescribe ketamine and clinics that dispense it. While ketamine clinics can obtain permission to dispense Schedule III controlled substances from the DEA, this requires strict compliance with all applicable provisions of the CSA.

Ketamine Diversion

One of the main risks with regard to the administration of ketamine in a clinical setting is the risk of diversion. Ketamine diversion can take various different forms, from patients selling ketamine they obtain from their clinics to clinics selling ketamine to unauthorized buyers. While both of these forms of diversion entail equal risk, they both present risks for clinics and physicians as well. As a result, if the DEA has any reason to suspect that your clinic is involved in ketamine diversion in any way, it will have every reason to conduct a thorough investigation.

Ketamine Drug Trafficking

In cases involving allegations of high-volume diversion, the DEA may allege that a ketamine clinic is engaged in drug trafficking. Drug trafficking is an extremely serious allegation that can trigger an array of other federal charges. If your ketamine clinic is facing allegations of drug trafficking, you will need to work with your defense counsel to determine what is at the root of the allegations, and then you will need to build a targeted defense strategy based on the specific facts at hand. Even if the allegations that led to the DEA’s investigation are false, you will still need to be able to convince the DEA that this is the case.

Legal Pulse: Key Statistics

95%Plea Bargaining

of criminal cases in NJ are resolved through plea agreements

Source: NJ Courts Statistics

40%Dismissal Rate

of criminal charges are dismissed or reduced with proper legal representation

Source: NJ Courts Annual Report

Statistics updated regularly based on latest available data

Illegal Prescription Drug Marketing

Illegal prescription drug marketing is another potential allegation in DEA investigations targeting ketamine clinics. As a matter of course, physicians at ketamine clinics should not be accepting payments from patients’ insurance companies for prescribing ketamine. As the use of ketamine for the treatment of depression, anxiety, and other conditions is not yet FDA-approved, insurance companies will not routinely cover the costs of patients’ treatments.

However, the DEA may also investigate whether ketamine clinics’ owners, operators, physicians, or staff members have engaged in illegal prescription drug marketing. This offense involves exchanging compensation for referrals or payment information, and it is prohibited under Section 7(b) of the federal Anti-Kickback Statute. While most cases of illegal prescription drug marketing involve the use of federally-funded health insurance programs such as Medicare and Tricare, it is entirely possible that a DEA investigation could lead to the discovery of alleged illegal prescription drug marketing involving private health insurance benefits as well.

Unlawful Use of Ketamine in Patients

As with any clinical treatment involving a controlled substance, one of the primary risks for ketamine clinics is the risk of patients abusing their medications. This could happen in a number of ways, and ketamine clinics must ensure that they have policies, protocols, and procedures in place to prevent all forms of patient misuse of the drug. This includes not only using the wrong dose of the drug, but also using the drug for the wrong purposes (i.e., using ketamine to treat conditions for which it is not indicated).

Failure to Conduct Appropriate Ketamine-Related Due Diligence

Another potential allegation in DEA investigations of ketamine clinics is the failure to conduct appropriate due diligence related to the use of ketamine. Since ketamine is currently only indicated for general anesthesia, the DEA expects that physicians will only prescribe and administer the drug when absolutely necessary. This requires that they conduct an appropriate level of due diligence before writing (and filling) prescriptions for the drug. This includes considering whether the patient’s condition is indicated for ketamine treatment, whether the patient’s needs can be adequately addressed with other medications, and whether the patient is at risk for ketamine addiction.