Category: Health Law Highlights

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Health Law Highlights

Wegovy Maker Novo Nordisk Sues Nine Spas, Clinics and Pharmacies Over Copycat Drugs

Summary of article from Reuters, by Patrick Wingrove:

Novo Nordisk, a Danish pharmaceutical company, has filed lawsuits against nine more U.S. entities, including medical spas, wellness clinics, and pharmacies, for selling products that allegedly contain semaglutide, the key ingredient in its weight-loss drug Wegovy. This brings the total lawsuits to 21 since June, targeting sellers of purported copycat versions of semaglutide. The recent lawsuits were filed in federal courts across six states, with some defendants accused of selling products directly to patients without medical prescriptions and others of selling products with no semaglutide or of lower strength than advertised. Novo Nordisk also found high levels of impurities in some products, posing significant health risks to patients. This legal action mirrors similar steps taken by Eli Lilly, Novo Nordisk’s main competitor in the obesity drug market, against entities selling products claiming to contain tirzepatide, the active ingredient in its weight-loss drug Zepbound.

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Health Law Highlights

FTC and DOJ Seek Public Help Identifying “Serial Acquisition Strategy” Targets

Summary of article from Seyfarth Shaw LLP, by Brandon Bigelow, Robyn Marsh:

The Federal Trade Commission (FTC) and the Department of Justice (DOJ) are expanding their investigation into businesses using “roll up” strategies to consolidate competitors and reduce competition across the U.S. economy. Previously, these agencies focused on the healthcare industry, but the new Request for Information invites the public to submit examples of companies using serial acquisition strategies in any industry. This move follows the FTC’s aggressive litigation against such strategies in the healthcare industry, as demonstrated in the case of FTC v. U.S. Anesthesia Partners, Inc. The May 23 Request for Information seeks input from a wide range of sources and invites them to identify specific examples of these strategies and their impact on competition. Public responses, due by July 22, 2024, may influence the government’s enforcement priorities and future actions across various markets and industries.

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Health Law Highlights

Is FTC’s Noncompete Rule a Concerning Development for Physicians?

Summary of article from Medical Economics, by Amanda Hill:

The Federal Trade Commission (FTC) has issued a rule prohibiting noncompete clauses, potentially impacting physicians nationwide. Critics argue this rule overreaches federal authority, creates ambiguities in exceptions, and exacerbates divisions between hospitals and physicians. While some physicians support the ban, arguing noncompetes give undue leverage to hospitals, others maintain that reasonable noncompetes can protect smaller practices. The rule introduces legal uncertainties and potential conflicts, with the U.S. Chamber of Commerce planning to challenge the decision. The FTC rule, despite its aim to protect the workforce, may instead cause confusion and legal disputes, potentially delaying its implementation.

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Health Law Highlights

As Healthcare AI Advances, How Do We Balance the Benefits With Privacy Concerns?

Summary of article from HackerNoon, by Emmanuel Akin-Ademola:

AI advancements are transforming the healthcare industry, with companies like GE Healthcare and Siemens Healthineers developing technologies for accurate scans and automating routine tasks. However, these innovations raise significant concerns about data privacy and potential breaches. To address these issues, technical approaches such as anonymizing, encryption, and privacy-oriented algorithms can be adopted, alongside robust legal frameworks to protect individuals’ medical records. Additionally, patient education on privacy practices and ongoing research into data privacy and automation algorithms are crucial. While AI holds great promise for healthcare, ensuring best security practices, regulatory compliance, and continuous research is essential for a secure and effective implementation.

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Health Law Highlights

How AI Is Enhancing Health Care

Summary of article from Dallas Morning News, by James B. Milliken:

The University of Texas System is embracing the potential of artificial intelligence (AI) in healthcare, despite concerns about job losses and bias. The inaugural UT System AI Symposium in Health Care will bring together AI experts from eight institutions to discuss the responsible integration of AI into healthcare. AI is proving beneficial in various areas like administrative tasks, cancer detection, and treatment planning. The UT System is also integrating AI into degree programs across its seven medical schools, and is working with Microsoft and other academic centers to set standards for AI deployment in healthcare. State legislators are focusing on AI’s responsible deployment, with the Texas Senate prioritizing AI in its 2024 interim legislative charges.

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Health Law Highlights

AI, Health Care, and the Realities of Being Human

Summary of article from Undark, by Arjun V.K. Sharma:

The “doorknob phenomenon” in medicine refers to patients revealing their most pressing concerns just as the doctor is about to leave. This article explores the tension between this deeply human aspect of healthcare and the rise of artificial intelligence (AI) in the medical field. While AI promises efficiency and precision, it may risk depersonalizing healthcare and overlook broader social determinants of health. The author emphasizes that despite the potential advantages of AI, the uniquely human connections between doctor and patient are irreplaceable. The future of healthcare should balance technological advancements with maintaining human empathy and understanding.

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Health Law Highlights

Healthcare Ransomware Attacks Lead to Uptick in ED Visits at Nearby Hospitals

Summary of article from Health IT Security, by Jill McKeon:

A research letter in JAMA has revealed that ransomware attacks on hospitals not only disrupt the targeted facilities but also impact neighboring hospitals. The study, which analyzed emergency department (ED) visits and patient discharge data from 2014 to 2020, found a temporary decrease in ED visits and inpatient admissions at attacked hospitals and a temporary increase in ED visits at unaffected nearby hospitals. However, there were no significant changes in inpatient admissions at nearby hospitals. The research identified eight ransomware attacks that disrupted 15 hospitals, with ED visits and inpatient admissions decreasing by up to 16.62% in the second week after the attack. These findings underscore the broader implications of ransomware attacks on healthcare facilities and the importance of cybersecurity in patient care and safety.

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Health Law Highlights

Why Physicians Are Ditching Their 9-5

Summary of article from D Magazine, by Will Maddox:

A recent survey by AMN Healthcare reveals that nearly half of physicians and advanced practice providers find locum tenens work more satisfying than full-time roles, citing improved schedules and burnout avoidance as key reasons. Locum tenens, a form of temporary healthcare staffing, has witnessed significant growth, with the number of physicians in these roles doubling since 2002. The survey found that 47% of respondents preferred locum tenens to permanent positions, but 45% would opt for a permanent role under the right conditions. Younger physicians seeking flexibility are increasingly moving towards locum tenens, with 81% starting in these roles right after graduation or mid-career. The roles are also diversifying, with a notable increase in Nurse Practitioners and Physician Assistants filling locum tenens positions.

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Health Law Highlights

Accelerated Approval Process Is Not Without Risk: Placing Recent FDA Action in Context

Summary of article from Troutman Pepper, by Kyle Dolinsky, Judith O’Grady:

The FDA withdrew approval for Pepaxto, a multiple myeloma drug, after post-marketing studies failed to confirm its clinical benefit. The drug had been granted accelerated approval, a pathway for drugs treating serious illnesses that offer therapeutic benefits over existing treatments. However, post-marketing studies are required to verify the drug’s benefit, and failure to do so can result in withdrawal of approval. This was the first time the FDA implemented formalized withdrawal procedures under the Food and Drug Omnibus Report Act of 2022. Despite the withdrawal, the risk of litigation concerning accelerated approval drugs remains unchanged.

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Health Law Highlights

Using A Value-Based Enterprise to Integrate Specialists and Primary Care: Taking Value-Based Care to the Next Level

Summary of article from Nelson Mullins Riley & Scarborough LLP, by Mike Segal, Edward White:

Within the value-based healthcare model, the majority of medical expenses come from specialist sectors operating under traditional fee-for-service payment models. A potential solution to this challenge could be the implementation of a Value-Based Enterprise (VBE) that promotes mutually beneficial contractual relationships between primary care providers and specialists in a low-risk regulatory environment. Thanks to new regulations under the Stark Law and Anti-Kickback Statute, a VBE can act as an “Innovation Center,” allowing healthcare professionals to develop their own initiatives aimed at providing high quality, cost-efficient care. It is proposed that Primary Care Provider (PCP) Risk Arrangements embrace patient attribution, apply for capitation payment arrangements, contract with high-quality specialists, and pay these specialists under a value-based framework. This system can help control total care costs and improve patient outcomes.