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
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
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
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
On February 17, 2021, California Senator Scott Wiener introduced SB-519, a bill that if passed, would decriminalize a host of both natural and synthetic psychedelic drugs. In this post, I’ll unpack what the law would do in its current form. Before I get into the specifics of the bill, there are three things that are
We have worked on several ketamine acquisitions, and one of the most important aspects of any deal is due diligence. Shortly after term sheets or letters of intent are executed, most buyers send out a due diligence request list to the seller. This post will focus on the healthcare regulatory issues a buyer will want
We are on record here at the law firm in support of Measure 109. We have friends and colleagues who have worked on the campaign and clients who have written checks, large and small. Legal psilocybin in Oregon? We like the sound of that. But do we unconditionally and unapologetically love the ballot measure? No,
