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Polsinelli

Beyond the Pump: The Iran War’s Adverse Impact on U.S. Health Care

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Key Takeaways - The closure of the Strait of Hormuz following the U.S.-Iran conflict is disrupting global health care supply chains and increasing costs for critical medical products....more

Arnall Golden Gregory LLP

CMS Calls on States to Submit Medicaid Provider Revalidation Strategies: What Providers Need to Know

Key Takeaways - The Centers for Medicare and Medicaid Services has directed states to expedite Medicaid provider revalidation, requiring two-year revalidation strategies within 30 days and focusing on high-risk providers not...more

Baker Donelson

DOJ Fraud Qui Tam Enforcement is Coming into FOCUS

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Department of Justice (DOJ) announced the Fraud Oversight through Careful Use of Statistics (FOCUS) Initiative on April 30, 2026, a new effort designed to increase False Claims Act (FCA) enforcement through partnerships with...more

Arnall Golden Gregory LLP

Won’t Get Fooled Again: FDA Tells a Drug Company Don't Rely on AI

Key Takeaways - The Food & Drug Administration issued a Warning Letter citing a drug company for inappropriate use of AI in pharmaceutical manufacturing, marking what appears to be the first time the agency has specifically...more

Robinson+Cole Data Privacy + Security Insider

Privacy Trends Fashion, Beauty, and Wearable Tech Brands Need to Watch

Fashion, beauty, and wearable technology brands are heading into 2026 with a lot more to think about concerning data privacy. What used to feel like a back-end legal issue is now shaping how companies design products,...more

Latham & Watkins LLP

CMS and FDA Announce New RAPID Program for Medicare Coverage of Breakthrough Medical Devices

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On April 23, 2026, the Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) jointly announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway....more

Verrill

Navigating PBM Reform: Regulatory Changes, Market Shifts, and Practical Guidance for ERISA Fiduciaries

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Pharmacy Benefit Manager (“PBM”) arrangements have long relied on rebates with limited transparency into true drug costs. Recent regulatory and market developments represent a shift toward greater transparency and better net...more

McGuireWoods LLP

Healthcare & Life Sciences Private Equity Deal Tracker: THL to Acquire Celerion From H.I.G. for $1.8 billion

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THL Partners will acquire Celerion from H.I.G. Capital for $1.8 billion, according to news releases and industry reports. Celerion, formed in 2010 and based in Lincoln, Nebraska, is a global provider of clinical...more

Jackson Lewis P.C.

Maine Revises Drug Testing Law, Broadens Employers’ Drug Testing Options

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Significant revisions to the Maine Substance Use Testing Law, 26 Maine Rev. Stat. 681 et seq., will take effect on July 29, 2026. Maine House Bill 1425 (2025-2026). New Types of Tests Permitted- Maine law currently...more

Dinsmore & Shohl LLP

DOJ’s Civil Fraud Section Announces “FOCUS” Initiative, Bolstering FCA Enforcement Capabilities

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Introduction - The Department of Justice (“DOJ” or the “Department”) has announced the Fraud Oversight through Careful Use of Statistics (“FOCUS”) Initiative to encourage proactive engagement with data miners seeking to...more

Cozen O'Connor

State AGs Pen EpiPen Settlements With Mylan

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Maryland AG Anthony Brown and North Carolina AG Jeff Jackson announced separate settlements with Mylan resolving allegations that the company used anticompetitive tactics to maintain EpiPen’s market dominance and drive up...more

DLA Piper

DEA rescheduling of marijuana: Initial steps taken, broader Schedule III review still pending

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The United States Department of Justice (DOJ) and the Drug Enforcement Administration (DEA) recently issued a press release announcing a final order that significantly impacts the federal treatment of marijuana under the...more

Bradley Arant Boult Cummings LLP

Adult-Use Marijuana to Be Rescheduled? Here’s What’s at Issue and How It Will Be Decided

There were massive cheers in the marijuana industry when Acting Attorney General Todd Blanche issued a final order last week that rescheduled FDA-approved marijuana medications and state-licensed medical marijuana. And for...more

Thompson Coburn LLP

The Changing Landscape of U.S. Food Additive Regulation: MAHA and the End of Business as Usual

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The “Make America Healthy Again” (MAHA) movement has rapidly turned food additive regulation from a niche issue into a mainstream political and business priority. Longstanding debates over ingredient safety, chemical...more

Phelps Dunbar

Employers Need to Update Workplace Policies After Medical Marijuana’s Move to Schedule III

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The Department of Justice (DOJ) moved certain medical marijuana products to Schedule III, broadening workplace rights and employer responsibilities. Employees using prescribed medical marijuana are now protected from...more

Jones Day

Innovative Insights: Legal Updates in the Life Sciences

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ISSUES AND UPDATES - Trade Secret Litigation Trends in Life Sciences - Trade secret litigation has risen sharply in recent years, driven by increased employee mobility, complex collaboration agreements, and heightened...more

Jones Day

Rising Scrutiny of Employer Health Plan Administration: ERISA Fiduciary Litigation, Federal Transparency Initiatives, State...

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As federal and state governments continue to prioritize drug pricing reform, employers across the nation face a rapidly evolving landscape of legal and regulatory scrutiny regarding the management of their health plans. A...more

Ankura

The Document Few May Read and Why It Is the Most Important Thing in Your SNP

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I was sitting with a model of care (MOC) recently — not skimming it, actually reading it — and it brought back a conversation I had with a colleague that I have not been able to shake....more

Foley & Lardner LLP

Skin Substitutes: $3.2 Million ALJ Decision for Florida Wound Care Practice

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Foley & Lardner LLP (Foley) secured a fully favorable Administrative Law Judge (ALJ) decision overturning $3,261,046.50 in Medicare overpayments assessed by the Centers for Medicare & Medicaid Services (CMS) against a Florida...more

Jones Day

The Proposed European Biotech Act, 100 Days On

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On December 16, 2025, the European Commission (the "Commission") published a proposal for a European Biotech Act (the "Proposed Biotech Act" or "Proposal"). The Proposed Biotech Act is a central pillar of the Commission's...more

Snell & Wilmer

Navigating Employee Privacy Rights

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Employee privacy continues to be a complex and evolving area. As workplace technology advances and states enact new protections, employers are increasingly called upon to balance business interests with employees’ reasonable...more

McGuireWoods LLP

DOJ’s New West Coast Strike Force Puts Health Care Providers on Notice

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On April 30, 2026, the Department of Justice’s (“DOJ”) National Fraud Enforcement Division (“Fraud Division”) announced the formation of the West Coast Health Care Fraud Strike Force, a multi-district enforcement initiative...more

Troutman Pepper Locke

Pennsylvania Targets AI Chatbot for the Unauthorized Practice of Medicine

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The Commonwealth of Pennsylvania has alleged an AI company’s chatbot engaged in the unauthorized practice of medicine. This lawsuit not only signals how state regulators are potentially evaluating AI-driven health...more

Dentons

2026 Legislative Session Adjourns Sine Die

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The Iowa legislature adjourned sine die on May 3, 2026, after marathon caucuses and floor debate through the night on Saturday, May 2, and most of the day on Sunday, May 3. Slated for 100 days, the legislature extended 12...more

Burr & Forman

Potential Legal Risks Associated with Peptides

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Peptides have emerged as one of the most rapidly evolving areas in modern medicine. According to those that promote the benefits of peptides, these short chains of amino acids can play critical roles in numerous biological...more

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