Ketamine is a Schedule III drug under the federal Controlled Substances Act (CSA). Physicians who dispense or administer it therefore must comply with a host of federal and state laws and regulations. This includes registering with the DEA at each location where the physician administers ketamine. But what about physicians who travel to a patient’s
Psychedelics developments in 2021 covered everything from legalization and decriminalization to pharmaceutical advances and public company milestones.
In April of this year, Florida’s first attempt at psychedelics reform failed, as a House subcommittee rejected HB 549. This bill, introduced by Rep. Michael Grieco (D-Miami Beach), would have legalized the use of psilocybin for mental treatment in the nation’s third most populous state. Despite this setback, 2021 could yet be a pivotal year
As we have written about before, the corporate practice of medicine doctrine (“CPOM”) is a creature of state law (click here to review a prior post on CPOM). While some states do not have a CPOM doctrine (like Florida), other states have very strict CPOM doctrines (like New York and California). At its core, CPOM
You are an experienced cannabis operator. You have dealt with nonsensical regulations. You’ve navigated the world of dealing with a highly regulated substance. You’ve solicited large investments and beat out your competitors. You’ve learned enough about corporate governance and tax to go toe to toe with the best. Think you can easily pivot to the
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
As the economy continues to flourish, there is a proliferation of merger and acquisition activity in the healthcare space. We continue to see a rise in ketamine clinic acquisitions as well as investors who are starting management services organizations (“MSO”) to assist such clinics with their administrative burden. Likewise, we have seen an increase in
Many ketamine clinics enter into management agreements with management services organizations (“MSO”). The MSO provides a litany of services to the professional entities (“PE”) that are owned by healthcare providers, including billing and collections, financial and accounting services, providing space to the clinic through a lease, strategic planning, marketing, and many other types of management
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. §
