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Ladas & Parry LLP

Hikma Pharmaceutical USA Inc. v. Amarin Pharma Inc.

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​​​​​​​In a unanimous decision of June 4, 2026 in Hikma Pharmaceutical USA Inc. v. Amarin Pharma Inc., authored by Justice Jackson, the Supreme Court clarified the pleading requirements for claims of induced patent...more

Saul Ewing LLP

Supreme Court Finds No Plausible Allegations of Induced Infringement Through Generic Pharmaceutical Manufacturer’s Label and...

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In the recent ruling in Hikma Pharmaceuticals v. Amarin Pharma, No. 24–889., the U.S. Supreme Court applied its pleading standards established in the Twombly and Iqbal line of cases and unanimously held plaintiff, Amarin...more

Arnall Golden Gregory LLP

60 Days and Counting: DOJ’s New Fast Track for Benefits Fraud Qui Tams

On May 27, 2026, Assistant Attorney General Brett A. Shumate issued a memorandum to attorneys in the Commercial Litigation Branch’s Fraud Section and to Assistant United States Attorneys handling FCA cases that may materially...more

Baker Donelson

CMS Finalizes Federal IDR Operations Rule: Key Changes to the No Surprises Act Dispute Resolution Process for Providers

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The U.S. Departments of Health and Human Services, Labor, and Treasury (the "Departments") and the Office of Personnel Management released a Final Rule on May 28, 2026, significantly restructuring the Federal Independent...more

Alston & Bird

DOJ to Fast-Track FCA Intervention Decisions

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The Department of Justice (DOJ) is sharply accelerating its review of benefits-fraud qui tam cases. Our White Collar, Government & Internal Investigations and Health Care teams investigate how a new memorandum signals faster...more

Stotler Hayes Group, LLC

Medicaid MythBusters: What’s Fact, What’s Fiction, and What It Means for You

Medicaid is an essential source of health coverage for millions of Americans, but it is also widely misunderstood. Misconceptions about who qualifies, what services are covered, and how Medicaid affects personal assets can...more

Bergeson & Campbell, P.C.

Hantavirus and the EPA: A Collaborative Defense Against Viral Threats — A Conversation with Dana S. Lateulere and James V. Aidala

This week, I was pleased to welcome back to the studio Dana S. Lateulere, Regulatory Consultant with B&C and its consulting affiliate, The Acta Group (Acta®), and James V. Aidala, Senior Government Affairs Consultant at B&C...more

UB Greensfelder LLP

Illinois Employers: NICU Leave Law Effective June 1, 2026

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The Illinois Family Neonatal Intensive Care Leave Act took effect June 1, 2026, and provides eligible employees with up to 20 days of unpaid, job-protected leave while a child of an employee is a patient in a neonatal...more

Venable LLP

New Complaint Challenges FDA's Denial of Dietary Supplement Health Claims

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A new lawsuit filed in the U.S. District Court for the District of Columbia tees up a potentially significant challenge to FDA's approach to health claims for dietary supplements and conventional foods....more

McCarter & English, LLP

New Jersey 2025 Regulatory Updates: Part 3

Part 3 of our 2025 New Jersey Regulatory Update highlights additional recently adopted rules and amendments impacting healthcare providers, long-term care facilities, residential operators, and licensed professionals. These...more

Bass, Berry & Sims PLC

Smoke is Not Fire: Fourth Circuit Rejects Stark and AKS Theories Built on Ordinary Business Practices and Conclusory Allegations

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It is not every day that an 83-page qui tam complaint alleging Stark Law and Anti-Kickback Statute (AKS) violations is dismissed at the pleading stage, particularly when filed by experienced relator’s counsel and accompanied...more

Allen Matkins

Pending State Law: New Labor Requirements for Pharmaceutical Research, Development, and Production Facilities

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The State Legislature is considering legislation that would extend skilled workforce, prevailing wage, and labor reporting requirements to privately owned facilities used for pharmaceutical research, development, or...more

Ropes & Gray LLP

Hospital and Health Systems Reimbursement Check - June 2026

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For many hospitals, off-campus provider-based facilities have long served as a vehicle for expanding access to care, achieving operational and clinical integration of services, and supporting eligibility for programs such as...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Supreme Court’s Unanimous Ruling in Hikma v. Amarin: A Game-Changer for Skinny Label Strategies

The pharmaceutical industry has been watching Hikma Pharmaceutical USA Inc. v. Amarin Pharma, Inc. (No. 24-889) closely for its potentially sweeping implications for generic drug competition, as discussed in our prior posts –...more

ArentFox Schiff

Gene Editing for Human Therapies Just Got a Shortcut: What the FDA’s New Draft Guidance Means for Your Business

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On June 2, the US Food and Drug Administration (FDA) released a new draft guidance called “Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing.”...more

Cozen O'Connor

AG James Multistate Coalition Secures $36.5 Million from CVS in Medicaid Fraud Settlement

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New York AG Letitia James has joined a bipartisan coalition of 36 AGs, and the United States Department of Justice (DOJ) has secured a $36.5 million settlement from CVS Pharmacy Inc (CVS) for fraudulently overbilling Medicaid...more

Morgan Lewis - Health Law Scan

CMS Proposes Significant Limits on Medicaid State Directed Payments

The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would significantly limit Medicaid managed care State Directed Payments (SDPs) and certain fee-for-service payments. These changes seek to...more

Cozen O'Connor

Hawaii AG Lopez Leads Multistate Push in Race to End Tobacco and Nicotine Sponsorships in Formula 1

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AG Anne Lopez is co-leading a coalition of AGs from 18 states and jurisdictions calling on Fédération Internationale de l’Automobile (FIA) and Formula 1 to prohibit sponsorships involving tobacco and nicotine products. This...more

Polsinelli

House Panel Moves to Block CMS’s AI-Driven Prior Authorization Program: What the WISeR Rider Could Mean for Providers

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Key Takeaways: The House Appropriations Committee approved a rider June 9 that would block FY 2027 funding for CMS’s WISeR model. Unless the rider becomes law, however, the AI-driven prior authorization program will remain...more

Arnall Golden Gregory LLP

Home Health & Hospice M&A in 2026: How AI is Changing Diligence and Deal Execution

This five-part series examines current trends in home health and hospice M&A as the sector enters 2026, including valuation discipline, compliance and clinical risk, the role of artificial intelligence, and how deal structure...more

Arnall Golden Gregory LLP

(In)Box Full of Letters: OPDP Published Untitled Letter Regarding Emails to Healthcare Professionals

Wilco’s 1995 song “Box Full of Letters” came to mind when we reviewed a recent Untitled Letter from the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) regarding emails to HCPs. We have written...more

Akerman LLP - Health Law Rx

A Sliding Door to the Future of Healthcare Enforcement: Will We Soon See DEI-Based False Claims Act Settlements in Healthcare?

The U.S. Department of Justice’s (DOJ) first False Claims Act (FCA) settlement under its new Civil Rights Fraud Initiative offers key insight for federal contractors, federal funding recipients and healthcare providers. Under...more

Holland & Knight LLP

California Enacts Mandatory Nurse-to-Patient Staffing Ratios for Acute Psychiatric Hospitals: Understanding the New Requirements...

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California's emergency regulations establishing mandatory minimum registered nurse (RN)-to-patient staffing ratios for acute psychiatric hospitals took effect on June 1, 2026, more than two decades after the original...more

McDermott+

Preview and perspective: What’s on the menu for the 2027 PFS?

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While we are still in the midst of a Medicaid regulatory feast, it’s getting hotter outside, which means only one thing in the health policy regulatory world: it’s almost time for Medicare payment reg season!...more

Bass, Berry & Sims PLC

No Surprises in Dispute Resolution: Final Rule Improves IDR Process for Providers

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On May 28, the Departments of Health and Human Services (HHS), Labor and the Treasury (collectively, the Departments), along with the Office of Personnel Management, released a final rule updating the federal Independent...more

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