Regulations continue to develop in Oregon for psilocybin services, and businesses will soon operate in the new industry. As we explained in a recent webinar, the new industry will be heavily regulated, and psilocybin-related businesses will be expected to strictly comply with these regulations and the Oregon Psilocybin Services Act. These businesses will need help
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 telehealth just got a big lifeline. On April 12, 2022, the Department of Health and Human Services (HHS) renewed its determination that a public health emergency (PHE) exists due to COVID-19. Obviously, this has been a hugely controversial move even if the renewal is only good for 90 days. This 90 day extension is
This article was originally published on Bill of Health, the blog of Petrie-Flom Center at Harvard Law School, as part of a digital symposium, A Macro View of Microdosing. In light of the widespread cultural and business culture adoption of microdosing, private sector employers should reconsider the implications of a blanket prohibition on workplace use of controlled substances. What
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
RICO (or the federal Racketeer Influenced and Corrupt Organizations Act) has been a thorn in the foot for cannabis companies since, well, the dawn of cannabis companies. RICO will be just as annoying for psychedelics companies. Today I will explain what RICO is and why RICO and psychedelics will have a rocky relationship. What is
Ketamine clinic providers engaged in the off label application of ketamine for patient treatment are nothing new in U.S. healthcare. What is relatively new is that many “psychedelics” companies are trying to infiltrate the ketamine clinic scene. These companies hope to gain a foothold, then expand into a fuller suite of psychedelic treatment services once
When a person ingests psilocybin, in any form, the effects can be unpredictable. Some people will feel no different than normal. Others find themselves in a state of emotional reflection, ranging from light to deep introspection. Yet some experience moments of fear, anxiety, or reliving past trauma. How may a facilitator assist a person experiencing
The DEA violates religious freedom through its opaque and arguably illegal process for applicants seeking religious exemptions to the Controlled Substances Act (CSA). I’ve made this point before. But today, I want to look at one of the more nefarious ways in which the DEA’s exemption process violates religious freedoms. To do that, I first
Importing drug paraphernalia is illegal under the federal Controlled Substances Act (CSA). However, the expansive definition of “drug paraphernalia” can complicate the understanding of what items fit into this category. Federal agencies, particularly U.S. Customs and Border Protection (CBP), consider many factors when determining if a particular item is unlawful or not. Importers of psychedelic-related products need
