Provider Relief Fund Update

Corporate defendants are frequently faced with a quandary—is the company’s highly sophisticated professional employee simply a fact witness or does their anticipated testimony propel them into the world of expert discovery? The individual knows the business inside and out, and typically has a comprehensive understanding of the entire industry, but the legal parameters of whether they qualify as a lay witness or expert witness in this context is not always clear. And either designation presents potentially significant risks. Companies must proceed with caution and consider the following before proceeding.

Husch Blackwell’s False Claims Act team previously covered the results of a rare False Claims Act (FCA) trial in which a federal jury found that a surgical product distributor was liable for paying kickbacks to physicians. The federal judge overseeing that trial initially entered judgment against the distributor defendants for $487 million after trebling the government’s actual damages and then adding penalties for each kickback-tainted claim.

On February 8, 2024, however, that same federal judge amended the judgment over concerns that the statutory penalties were unconstitutionally excessive. This article highlights the issue and explains what those accused of violating the FCA can learn from this decision.

Research into psychedelic-assisted therapy receives funding in the National Defense Authorization Act for Fiscal Year 2024.

In an epoch marked by rapid innovation in mental health treatments, a paradigm shift is on the horizon for the well-being of our armed forces personnel. Psychedelic-assisted therapy has surfaced as an innovative intervention for ailments such as depression, traumatic brain injury (TBI), and—perhaps most widely applicable to military personnel—post-traumatic stress disorder (PTSD). Combat veterans are significantly susceptible to PTSD, and the debilitating impact of PTSD can last a long time.

Psychedelics have the potential to treat chronic conditions such as post-traumatic stress disorder (PTSD), depression, obsessive-compulsive disorder (OCD), fibromyalgia, and various behavioral health conditions, yet psychedelics are not like traditional pharmaceuticals. The mode of administration often involves a psychotherapy component, necessitating a closer patient-physician relationship and making risk management crucial. In this post, we delve into the critical legal factors that researchers and practitioners must consider before embarking on psychedelic clinical trials. From the intricacies of Food and Drug Administration (FDA) approval for Investigational New Drug (IND) applications to the imperative Drug Enforcement Administration (DEA) registration, site selection criteria, harnessing digital health technologies, and the ongoing and essential nature of informed consent, each factor plays a pivotal role in ensuring the ethical, legal, and safe exploration of psychedelics in the clinical realm. Let’s unravel these legal considerations that pave the way for responsible and groundbreaking advancements in psychedelic medicine.

In response to the COVID-19 pandemic, pharmaceutical companies like Pfizer worked diligently to develop safe and effective vaccines. Following the FDA’s approval of these vaccines, many state governments and private employers—including those in the educational and medical fields—implemented policies requiring certain individuals obtain them. Some individuals subject to these policies have been challenging them in court ever since under a variety of constitutional and statutory arguments, largely without success. These cases typically alleged that government mandates violated the right to bodily integrity under the Fourteenth Amendment and that private employer mandates violated laws that prohibit discrimination based on disability and/or religious beliefs.

Amid the growing interest in psychedelic-assisted psychotherapy, especially with substances like MDMA, psilocybin, and ketamine, it becomes imperative to navigate the intricate landscape of legal considerations associated with this burgeoning field. While the therapeutic benefits are promising, each substance brings along its own set of risks, responsibilities, and legal complexities for providers. In this context, the establishment of ketamine clinics demands a comprehensive understanding of the legal framework. Five major legal areas should be examined when considering opening a ketamine clinic, ensuring compliance, and fostering a secure and ethically sound environment. These considerations span corporate formation, physician-psychotherapist agreements, the development of employee handbooks, insurance coverage, and the crucial distinction between independent contractors and employees. Let’s delve into these key legal facets that make for responsible and legally compliant practices within the realm of psychedelic medicine.

The plan of a healthcare consulting firm (the “Firm”) to give gift cards to physicians in exchange for referrals to new customers does not violate the Federal Anti-Kickback Statute (the “AKS”), according to an Advisory Opinion from the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”). The Firm provides practice optimization services including data analytics services, electronic health record consulting services, compliance monitoring, and assistance with Merit-Based Incentive Payment System (“MIPS”) performance measures and submissions. Importantly, the Firm does not provide any services, nor does it invest in or own any other entity that provides services, that would be paid for, in whole or in part, directly or indirectly, by a Federal health care program.

Under the proposed plan, the Firm would give current customers $25 gift cards in exchange for recommending its consulting services to other physicians. If the recommendation were successful, the recommender would receive an additional $50 gift card.

As previously reported in this post, criminal trials premised on upcoding evaluation and management (E/M) service codes are extremely rare. The Justice Department took that rare step in Maryland in connection with a practice in which Dr. Ron Elfenbein, a physician, billed Medicare and private payors a Level 4 E/M for patients receiving COVID-19 tests. That billing practice, which at times took place at drive-through COVID testing centers, resulted in Dr. Elfenbein’s indictment and conviction by a jury in Maryland federal court.

But on December 21, 2023, the federal judge who presided over that trial granted Dr. Elfenbein’s motion for judgment of acquittal, vacating the conviction. These motions are commonly made but seldom granted. Why was this particular motion for acquittal granted? And what can the healthcare community learn from this case? Read on for details.