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In a move signaling a major shift in federal priorities, the Centers for Medicare & Medicaid Services (“CMS”) recently announced it will limit federal funding for state Medicaid initiatives that support services beyond direct medical care. New policy guidance indicates that CMS intends to narrow the scope of the federal-state Medicaid partnership, refocusing matching funds on core healthcare services delivered to Medicaid beneficiaries. The timing is notable, as Congress and state Medicaid leaders brace for the potential of more significant cuts to federal funding for Medicaid in the upcoming federal budget reconciliation process.

Continue Reading CMS to Withdraw Federal Medicaid Match for Workforce, Social Needs, and Infrastructure: What States, Health Care Providers and Community Organizations Need to Know
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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
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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
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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 high demand for the drugs, Wegovy was added to the FDA’s drug shortage list in March 2022, and Ozempic in August 2022.[iii] Wegovy and Ozempic are the only FDA-approved semaglutide injection products.[iv]

Continue Reading FDA’s Semaglutide Shortage Resolution: Legal Implications and Risks for Compounding Pharmacies
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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
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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
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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
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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
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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 easier for consumers to understand their costs and enroll in coverage through HealthCare.gov. The changes in this Rule aim to minimize administrative burden, ensure program integrity, advance health equity, and mitigate health disparities.

Continue Reading May the Coverage Be With You: Navigating CMS’s Changes to the Health Insurance Marketplace
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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?