ketamine off label use
Psychedelics Law Blog

Ketamine and Off-Label Issues

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

california state made from puzzle pieces
Canna Law Blog

Ketamine Management Services Organizations (MSOs): The California Puzzle

Our law firm has seen an uptick in ketamine clients lately. And it’s no surprise as the drug picks up considerable speed with its off-label infusion applications for a slew of serious ailments, including depression and mood disorders. We’ve also been handling several M&A deals around ketamine clinics and the management companies that serve them.

utah ketamine
Psychedelics Law Blog

Utah Ketamine Clinics Face New Patient Monitoring Law

Earlier this year, Utah passed a law that will directly impact ketamine clinics. The new law is entitled “Anesthesia and sedation requirements – Unprofessional conduct – Whistleblower protection.” Ut. St. § 58-1-510. The new law is effective as of May 4, 2022, but the implementing regulations have been passed or implemented yet. We believe that

Ketamine Drug chemistry structure
Canna Law Blog

Ketamine Clinics and the DEA

Recently, we’ve been writing about ketamine-infusion clinics, which are increasingly popping up across the country (see a list of our past coverage at the end of this post). Over the coming weeks, we’ll dive deeper into individual laws and regulations governing clinics. Today, we focus on some of the high-level requirements of the Drug Enforcement

Ketamine Drug chemistry structure
Psychedelics Law Blog

Ketamine Clinics and the DEA

Recently, we’ve been writing about ketamine-infusion clinics, which are increasingly popping up across the country (see a list of our past coverage at the end of this post). Over the coming weeks, we’ll dive deeper into individual laws and regulations governing clinics. Today, we focus on some of the high-level requirements of the Drug Enforcement

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Psychedelics Law Blog

Ketamine, Internet Prescribing, and Telehealth– Say What?

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

ketamine telehealth
Psychedelics Law Blog

Ketamine Telehealth: An Update

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

Ketamine Clinic Acquisitions: Get the Law Right BEFORE the LOI
Psychedelics Law Blog

Ketamine Clinic Acquisitions: Get the Law Right BEFORE the LOI

We often receive calls from potential ketamine clinic clients that just signed a letter of intent (“LOI”) or term sheet to acquire entire medical practices that are undertaking ketamine treatments. In the psychedelics space, many companies are starting off with off-label ketamine treatments while building towards a bigger suite of psychedelic services as the laws

ketamine telehealth dea
Psychedelics Law Blog

Ketamine Telehealth Providers: Beware DEA

Federal law requires prior in-person evaluations before a physician can provide telehealth services. The federal government declared a COVID-19 public health emergency, essentially suspending this rule. Following this suspension, ketamine telehealth providers and other virtual telehealth providers popped up all over the country. In all likelihood, the emergency declaration will end soon, leaving the industry

ketamine clinic stark law
Psychedelics Law Blog

Ketamine Clinics and the Stark Law – Part I

The Physician Self-Referral Law, commonly referred to as the Stark law (42 U.S.C. § 1395nn), is one of several federal fraud and abuse laws. We have previously written about the federal anti-kickback statute (“AKS”) (click here to review). While the two laws may seem similar at first, they have very different rules and penalties. The