On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions.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 encompass “classic psychedelics” that are understood to be 5-HT2 agonists (e.g., psilocybin and lysergic acid diethylamide (LSD)) as well as entactogens or empathogens (e.g., methylenedioxymethamphetamine (MDMA)). This is the first FDA draft guidance that discusses designing clinical trials for psychedelic drugs.

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.

Executive Order GA-40

Following two weeks of trial testimony, a Travis County jury recently rendered a $10 million verdict in a novel corporate practice of medicine (CPOM) case. The jury found in favor of a physician hospitalist group that claimed a management company repeatedly broke its promise to comply with the state’s CPOM prohibition, putting profits over patients, among other wrongdoings.

The Department of Health and Human Services (HHS) through its Office of Inspector General (OIG), announced plans for significant updates and modernization of OIG compliance program guidance (CPG) to improve their accessibility and usability for healthcare entities.[1] Originally issued in 1998, the CPG provide healthcare organizations across the industry with guidance on developing, implementing, and maintaining internal compliance controls. In the 25 years since, the OIG has issued multiple and specific CPGs that apply to particular segments of the healthcare industry including Medicare Advantage organizations, hospitals, home health agencies, nursing homes, and clinical laboratories. However, over time the CPGs have not sufficiently kept up with the innovations and growth of the healthcare industry.

Cosmetic surgeries are on the rise. One study of cosmetic surgery data found that body procedures like tummy tucks, buttock augmentation, and liposuction increased by 63 percent from 2020 to 2021.[1] Facelifts were up 54 percent.[2] And breast procedures were up 48 percent.[3] According to that study, Americans spent over $14.6 billion on aesthetic procedures in 2021 with surgical revenues increasing by 63 percent.[4]

Healthcare employers can improve patient outcomes by infusing diversity, equity, inclusion, and accessibility (DEIA) into their hiring, retention, and training practices. Legal minimums require that employers cannot make employment decisions based on any protected category, including race, national origin, and sex. But beyond these requirements, healthcare organizations need to prioritize DEIA to mitigate negative patient…

Doctor working on laptop computer

The Department of Health and Human Services (HHS) has announced its plan to end the Federal Public Health Emergency (PHE) for COVID-19 on May 11, 2023. Due to the COVID-19 pandemic, emergency declarations, legislation, and regulatory waivers across government agencies, including the Centers for Medicare & Medicaid Services (CMS), allowed for flexibility in the delivery of care to patients, including the expanded use of telehealth. Originally intended to conserve healthcare resources and prevent unnecessary exposure to COVID-19, the use of virtual care has exploded since the beginning of the pandemic to become an intrinsic, essential part of the healthcare delivery system. Now, at the end of the PHE, we examine the path forward for telehealth and the extent to which providers may continue to offer it to patients.

Contract management has quickly and importantly developed into an area of focus for in-house counsel and business stakeholders. Effective contract management systems can increase internal accountability and decrease wait times and costs. Further, increased ownership and investment in the maintenance of contractual obligations allows for companies to better track data, including dollars spent, time spent, and results to report to key stakeholders. Given the benefits of effective contract management programs, it is unsurprising that leaders look to develop and implement their own contract management system.

Last month, The Economist published a call to action titled, “There is a worrying amount of fraud in medical research: And a worrying unwillingness to do anything about it.”[1] The article is the latest in a sequence of alarms that some clinical researchers might not be as squeaky clean as we would hope them to be. Senior DOJ officials have in turn emphasized in public remarks that investigating clinical research shortcomings is now a Justice Department priority, with the whistleblower bar following suit.