Click HERE to register for our upcoming FREE Q&A webinar on ketamine regulations and the future of therapeutic psychedelic medicines! In the next few years, the FDA will likely approve drug formulations containing psilocybin and MDMA. While there are still many unknowns concerning how psilocybin and MDMA-based drug therapies will be regulated, we believe that
Over the last year and change, I’ve written quite a bit about how the ketamine telehealth industry was in store for a rude awakening when the COVID-19 public health emergency (PHE) declaration ended. My most recent post, entitled “Bad News for Ketamine Telehealth” predicted an imminent shakeup in the industry due to the looming end
Last summer, my colleague, Ethan Minkin, published a post entitled “Utah Ketamine Clinics Face New Patient Monitoring Law.” The law in question applied a host of new requirements on anesthesia or sedation providers, which created a series of hurdles for ketamine clinics. A few weeks ago, a Utah state legislator submitted a bill that would
Earlier this week, President Joe Biden’s administration made an announcement that signals potential bad news for the ketamine telehealth industry. Effective May 11, 2023, the federal COVID-19 public health emergency (PHE) declaration will end. This is likely to plunge the entire ketamine telehealth industry into chaos in the coming months. If you are unfamiliar with
Last week, we presented a psychedelics webinar entitled “How to Protect Your Psychedelics Business.” The panelists were Paul Coble from our Phoenix office), me (Griffen Thorne from our Los Angeles office), and Graham Pechenik of Calyx Law in San Francisco. In the webinar, we presented on business law and intellectual property issues that will affect
In early 2020, the United States Department of Health and Human Services (DHHS) declared a public health emergency (PHE) due to the COVID-19 pandemic. DHHS extended the PHE numerous times over the last few years, most recently on July 15, 2022 for a period of 90 days. The PHE will expire on October 13, 2022
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
Federal law requires prior in-person evaluations before a physician can provide telehealth services. The federal government declared a COVID-19 public health emergency, essentially suspending this rule. Following this suspension, ketamine telehealth providers and other virtual telehealth providers popped up all over the country. In all likelihood, the emergency declaration will end soon, leaving the industry
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.
