Amid the growing interest in psychedelic-assisted psychotherapy – especially with substances such as MDMA, psilocybin, and ketamine – it has become imperative to navigate the intricate landscape of legal considerations associated with this burgeoning field. Of the numerous legal and practical considerations, a business should examine the following five key legal areas when considering opening a ketamine clinic to ensure compliance and foster a secure and ethically sound environment.
- Is the business structured according to state guidelines? Some jurisdictions restrict corporate entities from practicing medicine to guard against non-medical professionals exercising control over medical decisions. It is critically important to pay close attention to the laws and rules that apply in the specific state where the clinic will operate to avoid violating that state's corporate practice of medicine regulations.
- Are you getting the appropriate consent? The use of sublingual ketamine or ketamine lozenges is considered off-label. Practitioners should obtain informed consent from patients for such off-label uses prior to treatment. Some states require that patients consent to receive telehealth and have drawn up written terms that must be included in telehealth consent forms.
- Are you appropriately licensed? Virtual ketamine clinics should ensure that their practitioners are authorized to provide telehealth in the states where they are providing telehealth services. Practitioners should be licensed in the state where the patient receiving treatment is located; although this requirement was waived during the COVID-19 Public Health Emergency, waivers may not have continued in each state.
- Are your providers being appropriately supervised? Supervision requirements of advanced practice providers (APPs) vary by state. In some states, Advanced Practice Registered Nurses may prescribe controlled substances without supervision, but in other states, supervision may be required. Some states may require a written collaboration agreement between the supervising physician and the APP (e.g., Georgia, New York, and South Carolina), while some may limit the number of prescribing APPs that a physician may supervise at one time (e.g., California, Georgia, and Virginia).
- Are you structuring payment properly for providers? Determining the correct classification of therapists and health care professionals in ketamine clinics as either independent contractors or employees is crucial and complex due to varying state and federal laws. For instance, in New Jersey and California, workers are assumed to be employees unless they meet specific criteria. When considering compensation for providers, a state's fee-splitting laws must be reviewed.
To further the discussion about operating a ketamine practice, whether buying or investing in a ketamine practice, or starting your own practice or other psychedelic-assisted psychotherapy practice, contact Lisa Gora.