Ethan Minkin is a seasoned attorney and has counseled clients on a wide variety of matters. His expertise includes complex transactions, healthcare regulatory matters, corporate bankruptcies and complex litigation. Ethan has handled hundreds of closings, from mergers and acquisitions to finance deals and securitizations. He has also litigated hundreds of matters in his career, having been involved in many high profile cases. Ethan has also counseled clients for cannabis related matters, including acquisitions, litigation and regulatory advice. He is currently assisting clients with cannabis regulatory issues.
As most people know by now, ketamine clinics are prevalent in the United States. These clinics offer ketamine as a treatment for a variety of disorders, including pain relief, behavioral health disorders, opiate addiction, and many other ailments. Unfortunately, there are not many studies that demonstrate whether ketamine is efficacious for these various ailments because,
On February 16, 2022 and October 10, 2023, the FDA issued two warnings about the use of compounded ketamine. The first warning is entitled, “FDA alerts health care professionals of potential risks associated with compounded ketamine nasal spray,” and the second warning is entitled, “FDA warns patients and health care providers about potential risks associated
Many ketamine clinics in the United States offer treatments for various behavioral health conditions, including depression. However, many healthcare providers who work for these clinics are not trained in psychiatry and/or counseling. There are various legal issues with this type of fact pattern. Among other things, are healthcare providers who are not trained in psychiatry
Earlier this year, Utah passed a law that will directly impact ketamine clinics. The new law is entitled “Anesthesia and sedation requirements – Unprofessional conduct – Whistleblower protection.” Ut. St. § 58-1-510. The new law is effective as of May 4, 2022, but the implementing regulations have been passed or implemented yet. We believe that
We often receive questions from ketamine clinics regarding who must obtain a DEA registration to dispense controlled substances. There are two candidates to consider – the healthcare providers who work at the clinic and the clinic itself. Often, there is a misconception about whether a clinic needs to hold a DEA registration. We wrote about
One of the primary restrictions that ketamine clinics run into when retaining a Management Services Organization (MSO) are fee-splitting prohibitions. Fee splitting is a state law concept and can vary from state to state. In some instances, though, fee-splitting can also lead to issues under the federal healthcare fraud and abuse laws, as discussed below.
Ketamine clinics are run by various provider types in the United States. In some states, mid-level practitioners (e.g., Nurse Practitioners and Physician Assistants) can practice independently. In other states, such providers can only work independently if they are supervised or overseen by a physician. However, the question then becomes whether any physician can run a
We often receive calls from potential ketamine clinic clients that just signed a letter of intent (“LOI”) or term sheet to acquire entire medical practices that are undertaking ketamine treatments. In the psychedelics space, many companies are starting off with off-label ketamine treatments while building towards a bigger suite of psychedelic services as the laws
As we have written about before, the corporate practice of medicine doctrine (“CPOM”) is a creature of state law (click here to review a prior post on CPOM). While some states do not have a CPOM doctrine (like Florida), other states have very strict CPOM doctrines (like New York and California). At its core, CPOM
The Physician Self-Referral Law, commonly referred to as the Stark law (42 U.S.C. § 1395nn), is one of several federal fraud and abuse laws. We have previously written about the federal anti-kickback statute (“AKS”) (click here to review). While the two laws may seem similar at first, they have very different rules and penalties. The
