What Should I Do if the DEA is Investigating My Ketamine Prescription Practices
The response to a DEA investigation of ketamine prescribing practices is structured around the same principles as the response to a DEA investigation of opioid prescribing practices: retain experienced counsel immediately, preserve all relevant records, do not speak with investigators without counsel present, and develop a defense strategy before making any decision about how to engage the investigation.
The specific features of a ketamine investigation that differ from an opioid investigation, described throughout this section, affect the content of the defense strategy but not the basic framework for responding to the investigation. The practitioner who has been contacted by DEA agents about their ketamine prescribing, who has received a DEA subpoena for ketamine-related records, or who has had their controlled substance inventory audited in connection with ketamine administration needs experienced counsel as urgently as the practitioner whose opioid prescribing has attracted DEA attention.
Immediate Steps
The immediate steps following any indication of DEA interest in a practitioner’s ketamine practice are the same as for any DEA investigation. Do not speak with DEA agents without counsel present. Do not produce any records in response to an informal request before counsel has reviewed the request and the applicable legal obligations. Preserve all records that may be relevant to the investigation, including ketamine administration records, patient medical records, billing records, and controlled substance inventory records. Contact experienced federal healthcare fraud defense counsel and describe the specific nature of the DEA’s interest.
The preservation of ketamine administration records is particularly important because those records are both the primary evidence the government will rely on to establish that the administrations were clinically appropriate and the primary evidence the defense will use to demonstrate the same thing. A practitioner who discovers that their ketamine administration records are incomplete or that the controlled substance inventory records do not match the documented administrations has identified a compliance problem that must be assessed by counsel before any engagement with the DEA occurs.
The Clinical Record Review
The internal review of the ketamine clinical record, conducted under counsel’s direction and protected by the attorney-client privilege, is the first substantive task in the defense of a ketamine investigation. The review should assess whether the records adequately document the clinical basis for each ketamine administration, whether the dosing and monitoring protocols reflected in the records are consistent with applicable clinical guidelines, whether the patient population treated is consistent with the clinical indications for which ketamine was administered, and whether the controlled substance inventory records reconcile with the documented administrations.
The ketamine-specific clinical standards, including the professional society guidelines for ketamine infusion therapy, the FDA-approved esketamine protocols, and the published clinical evidence for off-label applications, are the standards against which the defense medical expert will assess the records. Counsel should identify and retain a medical expert with specific experience in ketamine clinical practice who can review the records against those standards and provide an opinion about the clinical appropriateness of the administrations.
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(212) 300-5196The Corporate Structure Review
If the ketamine practice is organized through a corporate structure involving management services organizations, professional medical corporations, or other entities, the investigation may extend to the corporate structure and the financial relationships among the entities. The review should assess whether the corporate structure complies with the applicable state CPOM doctrine, whether any financial relationships among the entities create anti-kickback exposure, and whether the entity’s compliance with DEA registration requirements at each operating location is complete.
Structural compliance failures discovered through the internal review should be assessed by counsel for their legal significance and for whether voluntary correction or disclosure is appropriate. A structural compliance failure that is identified and corrected before the government identifies it is a compliance failure whose remediation reflects good faith. The same failure identified by the government after the practitioner was aware of it but took no action is evidence of indifference that the government will characterize unfavorably.
Engaging the Investigation
After the internal review has provided a complete picture of the practice’s clinical and compliance record, counsel can assess the strategic options for engaging the DEA investigation. Pre-investigation engagement through a presentation to the prosecuting office, if the clinical record supports it, is available in ketamine cases on the same basis as in opioid cases. The clinical expert opinion that the administrations were within the usual course of professional practice, presented in a proffer session or written submission before any charge is filed, is the same tool available in both contexts.
Todd Spodek
Lead Attorney & Founder
Featured on Netflix's "Inventing Anna," Todd Spodek brings decades of high-stakes criminal defense experience. His aggressive approach has secured dismissals and acquittals in cases others deemed unwinnable.
The ketamine investigation that arrives at a practitioner whose clinical records are thorough, whose controlled substance inventory is accurately maintained, whose corporate structure is legally compliant, and who retained experienced counsel before making any statements to investigators is an investigation that begins from the most defensible starting point available. The investigation that arrives at a practitioner whose records are sparse, whose inventory is unreconciled, and who has already spoken with DEA agents begins from a position that requires reconstruction rather than defense. The starting point is not fixed. It is determined by what was done before the investigation arrived and in the first days after it did.
The Consultation Is Available Now
The practitioner whose ketamine prescribing has attracted DEA attention, who has received a subpoena or an inspection notice, or who has any reason to believe that their ketamine practice is under regulatory scrutiny has a situation that warrants consultation with experienced federal healthcare fraud defense counsel. That consultation is available now, is protected by the attorney-client privilege, and will provide the practitioner with the information necessary to understand their exposure and the options available for addressing it. The first call is where the response begins.
