On March 18, Governor Kate Brown appointed members to the Oregon Psilocybin Advisory Board, which held its first meeting on March 31. Since then, the Board has met monthly and created five subcommittees to study facets of the emerging psilocybin industry including research, equity, manufacturing, training, and licensing. I chair the Licensing Subcommittee, which focuses
The corporate practice of medicine doctrine (“CPOM”) and state anti-kickback prohibitions vary from state to state. While some states have statutory prohibitions, other states rely upon case law for CPOM. These issues are typically not heavily litigated. When there is case law covering these subjects, it is imperative to review and understand these decisions. They
In a prior post, we discussed the federal anti-kickback statute (the “AKS”) and the implications for ketamine clinics. In short, the federal AKS prohibits anyone from paying or receiving anything of value for the referral of patients where a federal government healthcare payment program is the payor (e.g., Medicare, Medicaid, VA, etc.). 42 U.S.C. §
We’ve been writing about psychedelics on this blog now for three years. I believe the first article I wrote covered Food and Drug Administration (FDA) approval of Compass Pathway’s drug trial for COMP360, a psilocybin formulation that eventually was patented. Since that time, a LOT has happened in the space, and we have seen all
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
