Description: Healthcare Law Insights is published by the Husch Blackwell Health Law Team and focuses on legal issues surrounding the healthcare landscape.
On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions. The guidance document applies to clinical trials that will be conducted under investigational new drug applications, including clinical trials that are not intended to support marketing applications. Notably, the use of the term “psychedelic” in the guidance document is intended to enco
In his article The Shield Becomes a Sword , Nick Healey discusses Article I, Section 38 of the Wyoming Constitution, which guarantees the right of every competent adult to make their own healthcare decisions and was passed in 2012 in response to concerns over the Patient Protection and Affordable Care Act (ACA) and its potential limitations on patient choice. Recently, the Wyoming Legislature’s attempts to restrict certain healthcare decisions, such as abortion and gender-affirming medical care, have been c
On June 14, 2023, a federal jury found that a Georgia physician knowingly violated the False Claims Act following a two-week trial on allegations that he made false claims to the Medicare Program. Now, despite just $1.1 million in improper payments stemming from false claims, a federal court is likely to impose a judgment that exceeds $27 million after adding statutory per-claim penalties and trebling the amount determined by the jury to be false.