Category: Health Law Highlights

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Health Law Highlights

What to Learn From DOJ’s First Telehealth-Prescribed Controlled Substances Case

Summary of article from Husch Blackwell, by Jonathan Porter:

On June 13, 2024, the Justice Department arrested two executives of Done Global Inc., a digital health company, marking the first criminal case against telehealth executives for allegedly causing illegal prescriptions of controlled substances. The charges include a drug dealing conspiracy, a healthcare fraud conspiracy, and obstruction of justice. Key lessons from the case include the importance of adherence to state and federal laws when prescribing controlled substances via telehealth, the risks of restricting prescribers’ access to patients and incentivizing prescriptions without follow-up evaluations, and the potential for prosecution under a drug-dealing conspiracy rather than the Anti-Kickback Statute. The case also highlights the potential challenges of proving such charges, particularly in light of the 2022 Supreme Court Ruan case, and the illegality and risks of deleting documents during an investigation. Despite this case, telehealth remains a valuable practice, but healthcare innovators should be mindful of the risks associated with restricting the physician-patient relationship.

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Health Law Highlights

Artificial Intelligence Governance – First, Build On What You Have

Summary of article from Guidepost Solutions LLC, by Kenneth Mendelson:

As AI technology rapidly advances, organizations must prioritize AI governance to ensure responsible and compliant use. Compliance involves adhering to global, federal, and state regulations, including new laws focused on AI use. Organizations should integrate AI considerations into their existing governance, risk-management, and compliance programs, conducting comprehensive AI risk assessments, updating policies and procedures, ensuring data privacy and security, and monitoring regulatory developments. It is also recommended to establish an AI Steering Committee to oversee AI governance efforts, including transparency, explainability, and ethical considerations. Documenting all AI governance and procedural efforts is crucial for demonstrating due diligence and responsible AI practice.

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Health Law Highlights

The Rise of Fiduciary Health Plan Litigation

Summary of article from The Wagner Law Group, by Michael Schloss, Stephen Wilkes:

In 2022, US health care spending reached $4.5 trillion, with $405 billion spent on prescription drugs and $800 billion paid through employer-sponsored health plans. A class action lawsuit, Lewandowski v. Johnson and Johnson, alleges mismanagement of the company’s health plans’ prescription-drug benefits, leading to higher costs for plan participants. The complaint argues that the company breached ERISA duties of prudence and loyalty and calls for various remedies. The defendants have filed a motion to dismiss the original complaint, arguing that the plaintiff received all benefits due to her under the plans and failed to plausibly allege an imprudent process for negotiating PBM services. The case serves as a wake-up call for health plan fiduciaries to review their PBM programs and consider the role of incentives and conflicts, among other measures.

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Health Law Highlights

FTC Signals Its Intent To Pursue Nonprofit Health Care Entities With Its Non-compete Ban Whenever Possible

Summary of article from Seyfarth Shaw LLP, by Jesse Coleman, Yumna Khan:

The Federal Trade Commission’s (FTC) Final Rule banning non-competes in worker agreements may not exempt nonprofit health care entities, including most hospital systems in the US. The FTC asserts that merely claiming tax-exempt status is not enough to be beyond its jurisdiction; it will also examine whether the corporation is organized for charitable purposes and whether either the corporation or its members derive a profit. The FTC has previously exercised jurisdiction over nonprofit entities engaged in business on behalf of for-profit members. The Final Rule, set to take effect on September 4, 2024, is currently facing legal challenges questioning its constitutionality. In the interim, nonprofit health care entities should consult with legal counsel to determine potential impact from the FTC’s non-compete ban.

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Health Law Highlights

Leveraging AI In Healthcare Operations

Summary of article from Forbes, by Brian Fugere:

The application of AI and machine learning in healthcare is transforming not only clinical areas but also operational and workforce management, with the global healthcare AI market projected to reach $427.5 billion by 2032. AI/ML can address pressing challenges in healthcare, such as complex workflows and administrative tasks, which currently consume 60%-80% of healthcare professionals’ time and contribute to workforce shortages. Learning from other industries, healthcare can implement AI/ML to optimize workflows, automate tasks, and improve operational efficiency. However, unique challenges in healthcare, including strict regulations and complex decision-making processes, necessitate careful consideration when adopting these technologies. By strategically and responsibly harnessing AI/ML, healthcare organizations can innovate and improve operations, leading to enhanced patient outcomes and a more efficient healthcare ecosystem.

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Health Law Highlights

How Chief AI Officers Are Guiding Healthcare Companies Into The Future

Summary of article from Forbes, by Andrei Kasyanau:

Artificial intelligence (AI) is transforming healthcare, necessitating the role of a Chief AI Officer (CAIO) to guide AI strategy and implementation, foster AI innovation, ensure ethical AI use, and build AI talent and partnerships. The CAIO is pivotal in identifying high-value AI opportunities, driving AI adoption, and overseeing the ethical deployment of AI systems. They also play a crucial part in building a strong AI talent pipeline and fostering strategic partnerships. Real-life cases from Mayo Clinic, GE Healthcare, and Elevance Health demonstrate the positive impact of a CAIO in healthcare organizations. The need for a CAIO becomes apparent when organizations face multiple AI initiatives, challenges in scaling AI solutions, concerns about AI ethics, and a need for dedicated AI talent and partnerships.

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Health Law Highlights

Four Ways Price Transparency Will Transform Healthcare

Summary of article from D Magazine, by Dr. Eric Bricker:

The lack of healthcare price transparency presents a significant challenge, particularly for insured individuals with high out-of-pocket costs. The federal government has mandated hospitals to disclose prices, but compliance remains low. Some health insurance companies are now linking out-of-pocket costs with healthcare providers’ price and quality, incentivizing patients to opt for high-value care. Price transparency will enable fair treatment of payers, encourage competition among providers, and could potentially reduce healthcare costs. Improved transparency is also expected to enhance the quality of care, countering the current system that often incentivizes lower quality.

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Health Law Highlights

Enhancing the Humanity in Health Care With AI

Summary of podcast from Deloitte Insights:

The World Health Organization predicts a shortage of 10 million healthcare workers by 2030, which could result in increased wait times, decreased health outcomes, and worker burnout. AI has the potential to alleviate these issues by automating administrative tasks, thereby freeing up clinicians’ time and making healthcare more human-centric. However, the adoption of AI in healthcare is slowed by apprehensions about the technology and concerns about data privacy. The successful implementation of AI in healthcare requires clinician adoption and leadership, and solutions must be designed to integrate seamlessly into existing workflows. Ultimately, AI has the potential to transform healthcare delivery, improve efficiency, and enhance patient care, but this requires a collaborative approach, robust data governance, and a focus on enhancing rather than replacing human roles.

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Health Law Highlights

Navigating the National Practitioner Data Bank: A Guide for Healthcare Professionals

Summary of article from Ward and Smith, P.A., by Amy G. Fitzhugh, James A. Wilson:

The National Practitioner Data Bank (NPDB) is a repository of reports on actions taken against healthcare practitioners, providers, and suppliers, aiming to prevent practitioners from moving locations without disclosing adverse events. Entities such as hospitals, health plans, and state licensing boards submit reports to the NPDB, which include Adverse Action Reports, Medical Malpractice Payment Reports, and Judgment or Conviction Reports. The NPDB, analogous to credit reports, contains information that could negatively impact a healthcare professional’s credentialing decision, and like a credit report, it is not publicly accessible but available to authorized users. To manage their NPDB profile, healthcare professionals should occasionally self-query their records, add their own side of the story if something is reported, and dispute inaccuracies with the reporting entity. If the reporting entity denies a correction, the NPDB has a process to dispute a report and, if in agreement, can request the reporting entity to correct or void the report.

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Health Law Highlights

With AI, Keep Patient Satisfaction Top of Mind, Says Health IT Investor

Summary of article from Healthcare IT News, by Bill Siwicki:

Artificial intelligence (AI) is poised to revolutionize healthcare, with investors viewing it with cautious optimism due to its potential for significant advancements and the need for careful consideration of secondary implications. AI can catalyze the shift towards value-based care by improving patient outcome measurement, personalizing treatments, and predicting health issues for early intervention. AI can also streamline the revenue cycle management process by automating tasks, predicting revenue leakage, and enhancing billing accuracy. While AI won’t replace clinicians, it will assist in decision-making by analyzing complex data points, providing evidence-based recommendations, and identifying potential drug interactions. Despite challenges like data privacy and integration into existing systems, AI’s development trajectory in healthcare is promising.