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Lotan Barbaresso

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Lotan Barbaresso is an associate in the Governmental Practice in the firm's Washington, D.C. office.

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In an era where artificial intelligence (AI) is reshaping landscapes in the healthcare industry and beyond, understanding the governance of AI technologies is paramount for organizations seeking to utilize AI systems and tools. AI governance encompasses the policies, practices, and frameworks that guide the responsible development, deployment, and operation of AI systems and tools within an organization. By adhering to established governance principles and frameworks, organizations can ensure their AI initiatives align with ethical standards and applicable law, respect human rights, and contribute positively to society. Various international organizations have set forth AI governance principles that provide organizations with a solid foundation to develop organizational AI governance based on widely shared values and goals.Continue Reading Navigating the Complex Landscape of AI Governance: Principles and Frameworks for Responsible Innovation

On August 21, 2024, Sheppard Mullin’s Healthy AI team conducted a CLE webinar on what hospitals, health systems and provider organizations should consider in building an artificial intelligence (“AI”) governance program. As they discussed, key elements of an AI governance program include: (1) an AI governance committee, (2) AI policies and procedures, (3) AI training, and (4) AI auditing and monitoring. These components of an AI governance program will help healthcare organizations embrace the complexities of AI use in healthcare by establishing appropriate guardrails and systematic practices to encourage its safe, ethical, and effective use. This post reviews each of the key elements.Continue Reading Key Elements of an AI Governance Program in Healthcare

An April 2024 independent[1] report (“Report”) analyzed the results of the first four years following implementation of the Maryland Total Cost of Care Model (the “TCOC Model”), finding that between 2019 and 2022 (the “TCOC Measuring Period”), the TCOC Model reduced Medicare spending, hospital admissions, and health disparities. CMS also distributed a summary of the Report’s findings.Continue Reading Attention Maryland Providers: Are You Availing Yourselves of Regulatory Flexibilities under the TCOC Model?

As artificial intelligence (AI) continues to transform the healthcare industry, hospitals, health systems, and provider organizations are increasingly recognizing the need for effective AI governance. But what exactly is AI governance, and why is it so crucial for healthcare organizations?Continue Reading Building a Robust AI Governance Program in Healthcare

With technology rapidly evolving and jurisdictions appearing blurred, it is increasingly important to be mindful of data flow and use. This is particularly true where patient data is being accessed by offshore subcontractors.Continue Reading Do You Catch Our Drift? Navigating the Waters of Offshoring and Patient Data

On August 2, 2024, the United States Fifth Circuit affirmed the rulings in the No Surprises Act litigation brought by the Texas Medical Association and other plaintiffs[1] challenging the August 2022 Final Rule that has been issued by the Departments of Labor, Treasury, and Health and Human Services (the “Departments”) that applied to the Independent Dispute Resolution (“IDR”) process created by the No Surprises Act (the “Act”).[2]Continue Reading No Surprises Here – Providers Win Again in No Surprises Act TMA II Litigation Vacating Independent Dispute Resolution Rule

If your organization has not updated its policies to comply with Utah’s Artificial Intelligence Policy Act (the “Act”), now is the time. As we noted in a prior blog post, this law took effect on May 1st. While it imposes certain AI-related disclosure obligations on businesses and individuals as a whole, the obligations for regulated occupations (which include those licensed by the Utah Division of Professional Licensing, such as clinical services provided by a licensed healthcare provider, including a physician or nurse), are stricter.Continue Reading Utah Providers – Are You Complying with the AI Policy Act?

On April 4, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued the contract year 2025 (CY2025) Medicare Advantage and Part D final rule (the “Final Rule”). In addition to finalizing its CY2025 proposed rule, CMS also addressed several key provisions that remained from the CY2024 proposed rule. According to CMS’ Fact Sheet, the Final Rule builds on existing Biden-Harris Administration policies to strengthen protections and guardrails, promote healthy competition, and ensure Medicare Advantage and Part D plans best meet the needs of enrollees. The Final Rule also promotes access to behavioral health care providers, promote equity in coverage, and improve supplemental benefits.Continue Reading CMS Issues CY2025 Medicare Advantage and Part D Final Rule

“The American people deserve to know that the insurance companies receiving more than $700B annually in taxpayer funds are working to ensure you receive effective, high-quality care. Remember, you have rights and options to ensure you receive the care you deserve.”Continue Reading OIG Sparks Public Excitement about Managed Care and Alludes to Incoming Enforcement Guidance

On January 17, 2024, the Departments of Health and Human Services, Labor, and the Treasury (collectively, the “Departments”) and the Office of Personnel Management issued a notice that they will reopen the period for submitting comments on the proposed rule, “Federal Independent Dispute Resolution (IDR) Operations” (the “Proposed Rule”) under the No Surprises Act (the “Act”).Continue Reading Comment Period for the No Surprises Act Proposed Rule, “Federal Independent Dispute Resolution (IDR) Operations,” Will Reopen

On November 6, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released the contract year 2025 proposed rule for Medicare Advantage (“MA”) organizations and Part D sponsors (the “Proposed Rule”). The Proposed Rule covers an array of regulatory topics including the Star Ratings program, marketing and communications, agent and broker compensation, health equity, dual eligible special needs plans (“D-SNPs”), utilization management, network adequacy, and access to biosimilars.Continue Reading CMS Promotes Competition, Transparency, Health Equity and More in the CY2025 Medicare Advantage and Part D Proposed Rule