On August 1, 2023, the New York State’s Department of Health (the “DOH”) began implementation of Public Health Law Article 45-A, the State’s new statutory requirement for advance notice and public disclosure of certain material healthcare transactions (the “Material Transactions law”). Now, in response to questions from the healthcare community regarding the reporting requirements and statutory interpretation, the DOH has released a set of Frequently Asked Questions (FAQs) to clarify the scope and application of the Material Transactions law.
Continue Reading New York State Releases Much Anticipated Guidance on Reporting Requirements for Material Healthcare Transactions as Budget Negotiations Near Conclusion, Potentially Expanding Law to Include Pre-Closing Review

Recent changes in federal immigration enforcement practices have prompted renewed attention to how healthcare providers manage requests from law enforcement agencies. While federal policy continues to recognize healthcare facilities as sensitive environments, there has been increased interest in enforcement activity in or around such locations. Healthcare organizations should consider taking this opportunity to review internal protocols and confirm they are prepared to respond in a manner that is consistent with applicable federal and state law.
Continue Reading Immigration Enforcement and Healthcare Facilities: Key Considerations for Providers

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

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 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

Sheppard Mullin partners, Cyrus Abbassi and Leonard Lipsky, served as panelists at the annual Orthopedics Today Conference in Kauai, Hawaii, held in January 2025. During a spirited discussion with various stakeholders in the orthopedics industry, they noted the following key takeaways:…
Continue Reading Four Takeaways from the Orthopedics Today Conference 2025

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