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
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FDA’s Semaglutide Shortage Resolution: Legal Implications and Risks for Compounding Pharmacies
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…
Proving Fraud is and Should Be Hard: Lessons from a Recent Medicare Advantage False Claims Act Decision
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.…
Healthcare Security is Homeland Security: A Discussion with Jonathan Meyer
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…
Medicaid in the Crosshairs What Restructuring Could Mean for States, Providers, and Beneficiaries
By Adam Herbst
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…
Updated: The Future of Gender-Affirming Care – New Legal and Regulatory Considerations for Hospitals Providing These Services
By Adam Herbst
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.…
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 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…
Four Takeaways from the Orthopedics Today Conference 2025
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:…
May the Coverage Be With You: Navigating CMS’s Changes to the Health Insurance Marketplace
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…
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
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…