Surgical Robot Liability: The Emerging Legal Landscape for Healthcare Providers and Manufacturers

In an intriguing shift away from conventional thinking, there has been recent discussion concerning product liability lawsuits pertaining to surgical robots. While it’s common to envision liability suits from patients after unsuccessful operations, it’s considerably less common to consider potential claims from healthcare providers over injuries sustained while operating these technological wonders. Shook, Hardy &…

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Navigating Recent Legal Advancements in the Telehealth Sector

As telehealth continues to revolutionize the way healthcare is delivered, keeping pace with legal developments in this sector is imperative for legal professionals navigating the sector. Between August 15 to August 21, 2023, several significant legal advancements concerning telehealth were observed. A detailed review of these occurrences was provided by McDermott Will & Emery, which…

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New Federal Measures Strengthen Mental Health Parity and Addiction Equity Act Compliance

In a significant move for those working in the insurance, healthcare and legal industries, the U.S. federal government introduced new regulations and guidance on July 25, 2023. These changes are aimed at improving adherence to regulations outlined in the Mental Health Parity and Addiction Equity Act (MHPAEA). The requirements of the MHPAEA mandate insurance companies…

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Navigating Shared Legal Custody during the Academic Year: A Guide for Legal Professionals

As we approach a new academic year, parents across Pennsylvania are beginning to prepare for the upcoming school year. Shared legal custody, however, introduces another layer of considerations as reported by Obermayer Rebmann Maxwell & Hippel LLP. Shared legal custody refers to the joint responsibility of running a child’s life. Parents are tasked with agreeing…

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Physician Convicted in Uncommon Criminal E/M Fraud Trial: Implications for Healthcare and Legal Sectors

In a recent legal event, a physician has been found guilty in a relatively unusual criminal Evaluation and Management (E/M) fraud trial. This case adds another layer of complexity in understanding E/M services, often described as “the core” of healthcare billing systems. The verdict has broader implications for medical and legal professionals worldwide, emphasizing the…

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OIG Advisory Opinion Sheds Light on Potential IONM Anti-Kickback Violations

On August 18, the Office of Inspector General in the Department of Health and Human Services (“OIG”) issued Advisory Opinion 23-05. In it, the OIG expressed concern that a suggested arrangement falling under the purview of surgeries requiring intraoperative neuromonitoring (“IONM”) might be in violation of the Federal anti-kickback statute. This proposed arrangement involved the…

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New York OMIG Proposes Regulatory Overhaul: Increased Compliance Thresholds for Medicaid Providers

The New York State Office of the Medicaid Inspector General (OMIG) has recently proposed sweeping adjustments to the regulatory regulations presiding over compliance programs. These changes are set to impact entities receiving substantial Medicaid revenue. The modifications suggest an increase from a threshold of $500,000 to $1 million. As a refresher, every Medicaid provider in…

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Kaiser Permanente Healthcare Workers Vote on Strike Authorization Amid Contract Negotiations

Next Monday marks the start of strike authorization votes by the 85,000 members of the Coalition of Kaiser Permanente Unions. Voting is expected to continue until September 13. The coalition, which accounts for half of Kaiser Permanente’s workforce, has raised concerns over the healthcare system’s unhurried attitude in addressing their grievances and offering an acceptable…

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Centene Corp Accused of Cancelling Interviews Over Religious Vaccine Exemptions

Healthcare giant Centene Corporation is facing allegations of cancelling job interviews due to religious accommodation for the COVID-19 vaccine, according to a complaint reported by Law.com’s Radar. The points of contention revolve around complex issues concerning individual rights and corporate policies with regards to health and safety. The complaint details that potential employees had their…

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FDA Approval of Tysabri Biosimilar Signals Key Milestone for Affordable Drug Alternatives

The United States Food and Drug Administration (FDA) has recently approved the biosimilar for Tysabri®, developed by Sandoz. JD Supra reports this as an important milestone in biosimilar drug production. It wasn’t long ago when the approval process and introduction of biosimilar drugs to the marketplace was moving at a slow pace, causing increasing worry…

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Advocate Aurora Health Settles for $12.25 Million in High-Profile Data Breach Lawsuit

In light of recent legal news, Advocate Aurora Health, a major player in America’s healthcare sector, has agreed to pay an eye-catching $12.25 million to settle a class action lawsuit resulting from a large-scale data breach. Through the use of tracking pixels on their website to monitor visitor activity, Advocate Aurora Health unintentionally compromised the…

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Illinois Addresses Health Disparities with Laws Fostering Provider Cultural Competency and Diversity

As an ongoing response to health disparities, the state of Illinois has implemented two laws this year to address these chronic issues, including concepts supportive of federal health equity promotion efforts. Starting in 2025, certain licensed healthcare providers in Illinois will be required to complete one hour of cultural competency training as part of their…

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FDA Draft Guidance to Address Inequality in Clinical Trial Representation for Drugs and Biological Products

The Food and Drug Administration (FDA) has recently issued draft guidance with regard to obtaining postmarketing data on populations who are typically underrepresented in drug clinical trials. The guidance, titled “Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products” is intended to help clarify the agency’s current stance…

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Nevada Joins Growing Movement to Strengthen Consumer Health Data Privacy Laws

In the midst of the COVID-19 pandemic, one could imagine the surprise among many, learning that HIPAA (Health Insurance Portability and Accountability Act), doesn’t give broad protection for all health-related data. This acknowledgment spurred conversations among lawmakers, leading to some states passing statutes designed to protect consumer health data. Nevada has recently joined other states,…

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Minnesota Attorney General Initiates Scrutiny on Medical-Billing Practices to Safeguard Consumers

In a significant shift, Minnesota Attorney General Keith Ellison announced a strategic reorientation of attention to medical-billing practices within the state. Ellison’s office will now be undertaking an initiative that involves proactive measures, including conducting public listening sessions and compiling online submissions to learn more about consumers’ experiences associated with medical billing. These steps signal…

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ERISA Preemption Reaffirmed: Tenth Circuit Rules in PCMA v. Mulready, Impacting Pharmacy Benefit Managers

In a recent, much-anticipated judgement given on August 15, 2023, the Tenth Circuit Court decided the PCMA v. Mulready case, rejecting Oklahoma’s argument that its pharmacy network requirements were not preempted by ERISA (The Employee Retirement Income Security Act). A detailed report on this judgment can be found in an article in JD Supra. The…

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Navigating Private Equity-Backed Healthcare: Unveiling Jennifer Steiner’s Mental Health Mission

In an informative Q&A session, Jennifer Steiner shares her journey across different levels of the healthcare services sector, from Fortune 100 companies to startups backed by private equity. Her current endeavor is a private equity-backed startup, presumably poised to make a meaningful impact in addressing the mental health crisis in the United States. This session…

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10th Circuit Upholds Federal Authority Over Medicare Advantage and Part D Plans, Bolstering ERISA Protections

In a strong legal stance, the U.S. Court of Appeals for the 10th Circuit issued a decision that reinforces long-standing federal protections. This decision primarily impacts employer and union-sponsored health plans, emphasizing their rights to design their own health benefit plans, including provider networks. Further pivotal to this judgement is the assertion that it is…

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Generative AI and the EU Artificial Intelligence Act: Impact and Implications for Industries

Following the European Commission’s proposed Artificial Intelligence Act in April 2021, industry focus has significantly shifted towards the rising number of AI solutions. More specifically, those that leverage Generative AI to create content such as text, images, or videos for various purposes across different industries, from entertainment to healthcare. Originally, these advancements were not seen…

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Navigating Third-Party Subpoenas in Heavily Regulated Industries: Prioritizing Compliance and Response Strategies

With the increasing prevalence of the False Claims Act (FCA) in heavily regulated industries, many companies and legal professionals are likely to encounter a third-party subpoena at some point. As a legal tool often used in discovery processes, it is imperative to understand how to respond when presented with one. Considering the ongoing litigation trends…

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DOJ Secures Fines and Divestments from Teva and Glenmark in Generic Drug Price-Fixing Case

Generic drug manufacturers Teva Pharmaceuticals and Glenmark Pharmaceuticals have recently become the sixth and seventh drug makers to resolve criminal charges as a result of the Department of Justice (DOJ) yearslong investigation into generic drug price fixing. The settlement agreement commands both companies to pay substantial fines as well as divest their drug lines for…

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