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. §
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
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
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
On November 3, 2020, voters in Oregon approved Measure 109, paving the way for a regime of psilocybin for therapeutic uses in a few years. Oregon and Psilocybin: Does the Approved Ballot Measure Language Stand a Chance Oregon Psychedelics: Petition to Legalize Psilocybin for Therapy Moves Forward Oregon Psychedelics: Psilocybin on the Ballot this November!
I was talking to another lawyer about last week’s vote by Oregonians to legalize psilocybin therapy here in the state. We discussed how licensed facilities won’t be up and running for a few more years, and how, in the meantime, people will have to make do with general decriminalization under Measure 109 and maybe, in
Religious organizations that want to use psychedelics for religious purposes and comply with U.S. law are forced to petition the United States Drug Enforcement Administration (DEA) to do so. The petition process is set out in a set of interim guidelines published by the DEA (Interim Guidelines).
The history of psychedelics in religion is long and mysterious, going back multiple millennia to prehistory. While the exact origins of these practices are too far back to determine, archeological evidence suggests mushrooms, DMT and other psychoactive substances have been used in religious ceremonies and rituals for at least 6,000 years. International treaties such as the Single Convention
Last week, the Multidisciplinary Association for Psychedelics Studies (MAPS) made a very big announcement: it had raised $30 million to complete its promising study of MDMA (ecstasy; molly) for treating post-traumatic stress disorder (PTSD). The Food and Drug Administration (FDA) already has granted MAPS “breakthrough therapy” approval based on earlier trials. With its recent cash
