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.

Continue Reading Federal Court Reduces FCA Penalties by 82 Percent Because of Excessive Fines Clause Concerns

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.

Continue Reading Advancing Military Mental Health

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.

Continue Reading Psychedelic Breakthroughs: Key Considerations for Clinical Trials

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.

Continue Reading Wash. Federal Judge Pokes Hole in New Wave of Vaccine Mandate Challenges

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.

Continue Reading Ketamine Clinics: Five Legal Considerations for Psychedelic-Assisted Psychotherapists

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.

Continue Reading Gift Card Giveaway Does Not Violate Anti-Kickback Statute, HHS Says

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.

Continue Reading Federal Judge Acquits Physician Following Criminal E/M Fraud Conviction at Trial

Plaintiffs often disclose medical experts to opine not only as to the diagnosis or prognosis of an injury or medical condition, but also as to whether the defendant’s actions caused plaintiff’s alleged injury/condition. In the usual course of treatment, physicians often focus simply on the diagnosis a patient’s injury/condition, rather than on what caused it. Thus, when medical records contain statements regarding causation, those statements typically derive solely from a patient’s own subjective statements. It is therefore important to distinguish between a patient’s subjective causation statements and objective medical evidence.

Continue Reading IPSE DIXIT: Because My Patient Said So – How to Challenge Medical Experts Who Base an Opinion of Injury Causation Solely on a Patient’s Self-Report

For years, law enforcement has bypassed traditional means of securing evidence by informal requests for documents from witnesses of crimes. At some point, that practice bled over into informal requests for healthcare providers’ documents, including documents reflecting protected health information (PHI). Healthcare providers, for the most part, have complied with these informal requests because, as the logic goes, law enforcement couldn’t possibly prosecute me for complying with law enforcement, right? Isn’t that entrapment?

This cooperative, well-intentioned practice by healthcare providers now appears to be drawing scrutiny from Congress. On December 12, 2023, members of Congress sent a letter to Health & Human Services Secretary Xavier Becerra announcing the results of a Congressional inquiry into the practice of pharmacies handing over patient information without legal process. In the face of that new scrutiny, which is sure to extend beyond pharmacies to all healthcare providers, what are healthcare providers to do when asked for PHI through informal means?

Continue Reading Should Healthcare Providers Give Law Enforcement Protected Health Information When Informally Requested? Congress Says No.

On November 28, 2023, the California Office of Health Care Affordability (“OHCA”) submitted proposed emergency regulations (the “Regulations”) on the reporting of certain transactions involving health care entities for review by the California Office of Administrative Law, the final step in the regulation process. The final Regulations, reflecting changes in response to public comments and those proposed by the Office of Administrative Law, were released on December 18, 2023, and will apply as of January 1, 2024, to covered transactions with a proposed closing date on or after April 1, 2024. Earlier articles covered the draft regulations and revised regulations, which parallels similar reporting regulations in nine other states, including Massachusetts, Washington, and Oregon. New York is proposing similar regulations for adoption in 2024.

This article will comment on the most recent changes to the Regulations and certain practical issues that must be considered in future transactions that will be subject to the reporting regime and cost and market impact reviews (“CMIR”).

Continue Reading California Health Care Transaction Reporting Regulations Update