As we stride further into 2025, the pharmacy industry faces a landscape teeming with challenges and opportunities. From tackling drug price transparency to juggling implementation of artificial intelligence, the industry is being transformed before our eyes. The journey ahead is anything but straightforward, with solutions ranging from bold, large-scale changes to more nuanced, focused innovations. Let’s delve into the high-level, dynamic trends shaping the pharmacy world today.Continue Reading Navigating the Evolving Pharmacy Landscape in 2025: Challenges, Opportunities and Innovations

The number of U.S. states implementing or considering new antitrust laws (or supplementing existing laws) targeting proposed transactions continues to grow. As detailed in our healthcare merger matrix, many states have focused their attention on the healthcare industry, and that continues to be the case, for example, in New York, where a broad range of proposed transactions involving health care entities could be subject to filing requirements and suspensory rules before they can close.Continue Reading State Antitrust Enforcement Roundup: New Laws; New Potential Legislation; and New (and Broader) Areas of Focus

On April 4, 2025, the Centers for Medicare & Medicaid Services (“CMS”) released the contract year (“CY”) 2026 final rule for the Medicare Advantage (“MA”) program, Medicare Prescription Drug Benefit Program (“Part D”), Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (the “Final Rule”). While CMS finalized several proposals of its Proposed Rule, it did not finalize many of its key proposals, including on anti-obesity medication (“AOM”) coverage, enhanced guardrails for artificial intelligence (“AI”), and various health equity related initiatives in MA and Part D.Continue Reading CMS Issues CY 2026 Medicare Advantage and Part D Final Rule

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

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 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

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