Healthcare Law Blog

Shaping the World of Healthcare Law

Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March 10th, the FDA issued guidance clarifying that 503A and 503B drug compounders must soon cease compounding semaglutide injection products[i] or risk enforcement action.[ii] This has a significant impact on compounding pharmacies as, under the Federal Food, Drug, and Cosmetic Act (the “FD&C”), drug compounders are permitted to compound their own copies of a patented drug if the FDA determines it is in shortage. Due to
Continue Reading FDA’s Semaglutide Shortage Resolution: Legal Implications and Risks for Compounding Pharmacies

The integration of artificial intelligence (AI) tools in healthcare is revolutionizing the industry, bringing efficiencies to the practice of medicine and benefits to patients. However, the negotiation of third-party AI tools requires a nuanced understanding of the tool’s application, implementation, risk and the contractual pressure points. Before entering the negotiation room, consider the following key insights:
Continue Reading Key Considerations Before Negotiating Healthcare AI Vendor Contracts

The litigator’s adage “it’s easy to plead, it’s hard to prove” once again came true in the long-running False Claims Act (FCA) case targeting Medicare Advantage (“MA”) plans operated by UnitedHealth (United). Eight years after the complaint was filed, a Special Master recommended granting United’s motion for summary judgment. U.S. ex rel. Poehling v. UnitedHealth Group, Inc., 2025 U.S. Dist. LEXIS 40921 (CD CA). Both the litigation and the Special Master’s report contain valuable insights for all FCA defendants, and especially for those matters involving allegations related to diagnosis coding.
Continue Reading Proving Fraud is and Should Be Hard: Lessons from a Recent Medicare Advantage False Claims Act Decision

In an era where cyber threats are escalating, healthcare has emerged as a critical battleground for security. Its significance has become increasingly crucial as the intersection of healthcare, cybersecurity, and technology permeates every aspect of our lives. In the fifteenth episode of Sheppard Mullin’s Health-e Law Podcast, Jonathan Meyer, former General Counsel of the Department of Homeland Security and current partner at Sheppard Mullin, offers a deep dive into the implications of cybersecurity threats on the healthcare industry as well as national security.
Continue Reading Healthcare Security is Homeland Security: A Discussion with Jonathan Meyer

State legislatures on the West Coast are intensifying their focus on private equity and management service organizations (MSOs) in healthcare, introducing new regulatory measures that could significantly reshape investment strategies, ownership structures, and operational matters in the healthcare space in these states. As state legislatures respond to growing concerns about the role of non-licensed entities in healthcare decision-making, recent proposals reflect a heightened focus on transaction scrutiny, ownership structures, and the autonomy of licensed providers.
Continue Reading Major Regulatory Updates from the West Coast: New California and Washington Approaches to Healthcare Private Equity and MSO Regulation

As budget negotiations heat up in Washington, Medicaid has emerged as a key target for cost-cutting measures. With policymakers looking to trim federal spending while maintaining commitments to Social Security and Medicare, Medicaid is one of the few major programs left on the table. Proposals floating around Capitol Hill include everything from block grants and per capita caps to stricter eligibility requirements and reductions in federal matching rates. These potential changes could fundamentally alter the structure of Medicaid, shifting more financial responsibility to states and reshaping access to care for millions of Americans.
Continue Reading Medicaid in the Crosshairs What Restructuring Could Mean for States, Providers, and Beneficiaries

As legal and policy developments continue to evolve, hospitals and health care professionals that provide gender-affirming care face new uncertainties regarding federal funding, compliance, and patient access. While these changes may not impact health care organizations that do not offer gender-affirming services, those that do must stay informed to navigate the rapidly changing legal landscape.
Continue Reading Updated: The Future of Gender-Affirming Care – New Legal and Regulatory Considerations for Hospitals Providing These Services

The recent U.S. election has had profound implications for the healthcare industry, prompting industry leaders to reexamine their strategies and day-to-day operations. At the Miami Herbert Business School’s annual “The Business of Health Care” conference on January 24, 2025, a pivotal forum brought together stakeholders across key sectors—home care, hospital systems, payors, and others—to assess the election’s impact and chart a path forward. The conference highlighted the need for collaboration, innovative solutions, and strategic leadership in addressing the challenges ahead.
Continue Reading Healthcare Industry Leaders Predict Four Areas to Watch After the U.S. Election: Takeaways from the Business of Health Care Conference Hosted by the Miami Herbert Business School

The Department of Health and Human Services (“HHS”) Centers for Medicare & Medicaid Services (“CMS”) recently issued the final “HHS Notice of Benefit and Payment Parameters for 2026” (hereinafter referred to as the “Rule”) setting new and updated standards for Health Insurance Marketplaces and health insurance issuers, brokers, and agents who help connect millions of consumers to health insurance coverage. Effective January 15, 2025,[1] the Rule finalizes additional safeguards for marketplace coverage beginning plan year 2026, protecting consumers from unauthorized changes to their health care coverage, ensuring the integrity of the federally facilitated Marketplaces, and making it
Continue Reading May the Coverage Be With You: Navigating CMS’s Changes to the Health Insurance Marketplace

Hospitals charge a standard evaluation and management services fee (“EMS”) for patients seen in the emergency room, in one of five amounts, depending upon the severity of the visit. This EMS fee is listed in the hospital’s public “chargemaster,” a comprehensive price list required by law. But does the hospital also have a duty to inform individual ER patients, before they receive services, about the EMS fee?
Continue Reading California Supreme Court Rejects Non-Disclosure Theory for ER Evaluation and Management Fees, Holding that Hospitals owe no Additional Duty Outside Regulatory Pricing Disclosure Regime

The proposed New York Health Information Privacy Act (NYHIPA), currently awaiting Governor Kathy Hochul’s signature, represents a major step in the state’s approach to protecting personal health data in the digital age. At its core, the bill aims to establish stronger privacy protections and restrict the use and sale of health-related data without explicit user consent. Supporters see it as a necessary evolution of data privacy laws, addressing gaps in federal regulations like HIPAA and responding to growing consumer concerns.
Continue Reading New York’s Health Information Privacy Act: A Turning Point for Digital Health or a Roadblock to Innovation?

In January 2025, New York Governor Kathy Hochul proposed legislation within her FY 2026 Executive Budget that could significantly reshape healthcare transactions in the state. This legislation introduces a “Cost Market Impact Review” (CMIR) process for material transactions involving healthcare entities, aiming to assess their effects on cost, quality, access, health equity, and competition. While the proposal has sparked conversations across the healthcare and private equity sectors, it offers a pivotal opportunity for strategic planning and collaboration if approached with foresight.
Continue Reading Navigating New York’s Proposed Cost Market Impact Review

On January 8, 2025, Massachusetts Governor Maura Healey signed House Bill 5159 (“H.5159”) into law, marking a notable expansion of the regulation of private equity investments within the Massachusetts healthcare sector. The legislation, set to take effect on April 8, 2025, introduces new measures to enhance transparency and accountability in healthcare transactions, focusing specifically on private equity firms, real estate investment trusts (“REITs”), and management services organizations (“MSOs”). This development also reflects a broader trend across the nation of increasing scrutiny of healthcare transactions and investments by private equity firms and other investors, as highlighted in our previous blog series
Continue Reading Massachusetts Expands Oversight of Private Equity Investment in Healthcare: Key Takeaways from House Bill 5159 Signed into Law by Governor Healey

President Trump was sworn into office on Monday, promising swift action on several fronts. There is already a new Federal Trade Commission (“FTC”) Chair, Andrew Ferguson, with former FTC Chair Lina Khan expected to step down shortly. At the Department of Justice, Antitrust Division (“DOJ”), proposed AAG Gail Slater will need to be confirmed by the Senate before she can take the helm.
Continue Reading Looking Back and Looking Forward: Healthcare Antitrust in a New Administration: What Stays the Same and What Changes?

I’m honored to participate in the University of Miami’s Business of Health Care Conference on January 24, 2025. This highly anticipated event brings together leaders from the nation’s most influential health care organizations to discuss the evolving health care landscape under the incoming administration.
Continue Reading Health Care at a Crossroads: Insights from the Post-Election Health Care Conference