The recent uptick in ketamine clinic and management service organization (“MSO”) clients at our law firm is pretty significant. It’s understandable given the groundswell of momentum behind state and local legalization and decriminalization of certain other psychedelics. Many companies that are exploring psychedelic medicines are making their way into the ketmaine space. Unlike psilocybin though
Yesterday, on June 30, the Petrie-Flom Center at Harvard Law School announced the launch of a three-year research initiative, the Project on Psychedelics Law and Regulation (POPLAR). The initiative will be led by Harris Sliwoski attorney Mason Marks, who also serves on the Oregon Psilocybin Advisory Board. As we’ve covered extensively on this blog, the
In a prior post, we discussed some of the various Federal laws that apply when a ketamine clinic is a Medicare provider (or accepts reimbursement from another Federal program, like Medicaid, the VA, etc.). Click here to review the post. While other Federal laws apply in these situations (e.g., the Stark Law, the Federal False
Excitement abounds about the status of MDMA, otherwise known as Ecstasy. And for good reason. As noted last month in the New York Times: …those who received MDMA during therapy [in clinical trials] experienced a significantly greater reduction in the severity of their symptoms compared with those who received therapy and an inactive placebo. Two
Earlier this year, I wrote a post entitled “California May Decriminalize Psychedelics”. My post discussed a piece of legislation that was introduced (SB-519), which would decriminalize a host of psychedelic drugs. You can read about what exactly SB-519 would do in my prior post, but I want to again emphasize that the bill in its
Our firm has seen a recent increase in ketamine clinic clients, both domestic and foreign (including for ketamine clinic buyers engaged in M&A, see here and here). In both camps, certain questions keep cropping up regarding starting, operating, and managing a ketamine clinic venture in the states. And what’s abundantly clear is that many people
Psilocybin mushrooms, also called magic mushrooms, are psychedelic drugs that can lead to hallucinations and altered thinking. The laws around psilocybin can be challenging to keep up with since there is some ambiguity and confusion between federal, state and local laws. As psychedelics are growing in popularity across the country for therapeutic, medicinal, spiritual, and recreational
In prior posts, we discussed some of the common due diligence and compliance issues for ketamine clinics (see here and here). In this post, we discuss a healthcare compliance plan and the importance of having one in place for ketamine clinics. The Department of Health and Human Services (“HHS”) (which houses, among other agencies, the
A common question that arises in Ketamine clinic transactions is whether a clinic or physician (collectively, “healthcare providers” or “providers”) can use or promote Ketamine for off-label uses. The short answer is yes, subject to several caveats, as discussed below. However, before reaching the answer, it is important to define what “off-label” use means and
Efforts by the Multidisciplinary Association for Psychedelic Studies (MAPS) to legalize prescription MDMA (Ecstasy) appear to have passed a gigantic hurdle earlier this month: MDMA is on track to meet the testing requirements to be a legalized prescription drug, specifically intended to treat the symptoms of post-traumatic stress disorder (PTSD). After analyzing the preliminary results
