On September 28, 2024, Governor Gavin Newsom signed into law California Assembly Bill 3030 (“AB 3030”), known as the Artificial Intelligence in Health Care Services Bill. Effective January 1, 2025, AB 3030 is part of a broader effort to mitigate the potential harms of generative artificial intelligence (“GenAI”) in California and introduces new requirements for healthcare providers using the technology.Continue Reading California Passes Law Regulating Generative AI Use in Healthcare
California is poised to pass a ballot measure aimed at imposing 340B spending restrictions for certain healthcare entities participating in the 340B Program who have historically engaged in spending that is not directly related to patient care and have also owned or operated multifamily dwellings with significant safety issues.Continue Reading California Votes to Impose 340B Spending Restrictions on Targeted 340B Providers
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
Leading up to the U.S. presidential election this November, our Antitrust & Competition team will offer thoughts and insights into what antitrust enforcement will look like under the next presidential administration. While there is at least some uncertainty regarding antitrust enforcement under either a Harris or Trump administration, there is no doubt that the current Biden administration has been extraordinarily active.Continue Reading Election 2024 Coverage: Examining the Future of Healthcare and Antitrust
California’s Office of Health Care Affordability (OHCA) has officially approved amendments (“Amendments”) to the cost and market impact review (CMIR) regulations, effective August 22, 2024. Most significantly, these Amendments expand the scope of health care entities (HCEs) subject to a CMIR, among other notable changes discussed below.Continue Reading Update: OHCA Approves Amendments to Cost and Market Impact Review (CMIR) Regulations
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?
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
In the high-stakes realm of False Claims Act (FCA) litigation, per-claim penalties can reach daunting levels that dwarf even treble damages. A recent ruling from the Eighth Circuit Court of Appeals provides valuable guidance on the limits of penalties under the Constitution’s Excessive Fines Clause (Clause). In Grant ex rel. United States v. Zorn, the Eighth Circuit applies the Clause in FCA litigation to identify when a penalty for purely economic loss offenses might be considered excessive. Specifically, the Court held that:Continue Reading There Are Limits! Reining In FCA Penalties Pursuant to the Excessive Fines Clause
On July 18, 2024, the Massachusetts Senate passed S. 2871, An Act Enhancing the Health Care Market Review Process (the Bill), to increase oversight of healthcare transactions involving private equity firms, real estate investment trusts, and management services organizations (MSOs). The Bill is another example of the increasing trend towards curbing private equity influence in health care, as highlighted in our previous blog series on California’s Assembly Bill 3129.[1] In Massachusetts, 51% of all healthcare provider transactions in the past decade have involved private equity firms,[2] and the Bill targets such involvement with the goals of expanding care and medication access and improving transparency and affordability, particularly in the primary care space.Continue Reading Massachusetts Senate Passes Bill to Increase Oversight of Private Equity Healthcare Transactions
On June 6, 2024, California Attorney General Rob Bonta announced that he led a multistate coalition of eleven (11) state attorneys general in in submitting a comment letter (the “Comment Letter”) in response to the Federal Trade Commission, the U.S. Department of Justice, and the U.S. Department of Health and Human Services’ (together the “Agencies”) request for information regarding consolidation in healthcare by private equity. On March 5, 2024, the Agencies issued a “Request for Information on Consolidation in Healthcare Markets,” on the same day the Agencies hosted a public workshop regarding the impact of private equity investment in the healthcare system. Continue Reading California Attorney General Advocates for Greater Antitrust Enforcement in Private Equity in Healthcare