A Non-Expert with Expertise: Navigating the Risks and Rewards of Testimony from Highly Sophisticated Professional Employees in Federal Court
Healthcare Law Insights
by Kate Ledden and Maddie Kincaid
1w ago
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 ..read more
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Federal Court Reduces FCA Penalties by 82 Percent Because of Excessive Fines Clause Concerns
Healthcare Law Insights
by Jonathan Porter
1w ago
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 ..read more
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Advancing Military Mental Health
Healthcare Law Insights
by Kimberly Chew
3w ago
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 c ..read more
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Psychedelic Breakthroughs: Key Considerations for Clinical Trials
Healthcare Law Insights
by Kimberly Chew and Natasha Sumner
1M ago
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 intricac ..read more
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Gift Card Giveaway Does Not Violate Anti-Kickback Statute, HHS Says
Healthcare Law Insights
by Ragini A. Acharya and Matthew Deutsch
1M ago
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 ..read more
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Federal Judge Acquits Physician Following Criminal E/M Fraud Conviction at Trial
Healthcare Law Insights
by Jonathan Porter
2M ago
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 ..read more
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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
Healthcare Law Insights
by Michael Nolan and Mary Kate Mullen
2M ago
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 stat ..read more
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Should Healthcare Providers Give Law Enforcement Protected Health Information When Informally Requested? Congress Says No.
Healthcare Law Insights
by Jonathan Porter
2M ago
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 n ..read more
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California Health Care Transaction Reporting Regulations Update
Healthcare Law Insights
by Andrew J. Demetriou
2M ago
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. E ..read more
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The First Leap to Receive Approval for a Novel Approach to PTSD Treatment
Healthcare Law Insights
by Natasha Sumner, Kimberly Chew and Karen Luong
2M ago
On December 12, 2023, the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (“MAPS PBC”) announced it has submitted a new drug application (“NDA”) to the FDA for the use of 3,4-Methylenedioxymethamphetamine (“MDMA”) for the treatment of post-traumatic stress disorder (“PTSD”). This novel therapy utilizes the administration of MDMA, a psychoactive substance that binds to the 5HT2a portion of the serotonin receptor, in a clinical setting in conjunction with psychotherapy. It represents a new modality of treatment that addresses a traditionally drug-resistant mental ..read more
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