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Polsinelli

Settlement Dominoes: The FTC’s PBM Playbook is Going Industrywide

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The FTC’s insulin/pharmacy benefit managers (PBM) enforcement matter is starting to look less like a single case—and more like a regulatory reset executed through settlement. On March 3, 2026, the FTC extended the stay...more

Weber Gallagher Simpson Stapleton Fires &...

Legislation Planned to Address Excessive Costs for Prescription Topical Drugs in Workers' Compensation

Most employers and their insurance resources are aware of the abusive cost structures associated with prescription compound topical drugs/creams being sold to our Commonwealth’s injured workers. The central objection about...more

Verrill

New England Health Care Fraud Strike Force Secures Its First Corporate Resolution in Massachusetts Since Its Expansion

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On March 5, the Department of Justice announced that it secured a Deferred Prosecution Agreement (“DPA”) with ExThera Medical Corporation after a former executive admitted to concealing the death of patients who were treated...more

Baker Donelson

Shift in U.S. Cyber Strategy: What the White House's New Offensive Cyber Posture Signals for Businesses

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For years, U.S. cybersecurity policy has largely followed a familiar formula: strengthen defenses, share threat intelligence, and improve resilience after attacks occur. But as ransomware gangs cripple hospitals, nation-state...more

Saul Ewing LLP

Maryland's New Health Care Noncompete Law—Is the Cure Possibly Worse Than the Disease?

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Maryland's health care noncompete and conflict of interest law, passed in 2024 but effective July 1, 2025, was intended to solve a host of problems with respect to noncompetition and similar agreements in Maryland's...more

Venable LLP

BiologicsHQ Monthly Injection - February 2026

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Welcome to Venable’s BiologicsHQ Monthly Injection - February 2026....more

Paul Hastings LLP

New CMS Requirements for Average Sales Price Reporting: What Pharmaceutical Manufacturers Need to Do by April 30

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The Calendar Year 2026 Physician Fee Schedule Final Rule includes several targeted, but material, changes to the average sales price (ASP) calculation and reporting that directly impact pharmaceutical manufacturers, with...more

McGuireWoods LLP

McGuireWoods Women’s Health Newsletter – March 2026: Regulatory and Transactional Developments

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The McGuireWoods Women’s Health Newsletter delivers information on the latest legal and regulatory developments affecting the women’s health industry. The publication provides timely analysis of legislative changes,...more

Epstein Becker & Green

Health Care Workplace Violence Legislation Heats Up in 2026

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In the wake of shootings in early March at hospitals in Atlanta and Milwaukee, the nation’s attention again turns to how to prevent workplace violence in health care settings....more

Williams Mullen

Virginia HB 717: Potential Changes Coming to Nursing Home Licensure?

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A bill introduced in the Virginia General Assembly aims to bring changes to nursing home licensure. House Bill No. 717 will require new operators to obtain a change of operator license before taking over daily operations...more

Butler Snow LLP

Arbitration Not a “Health-Care Decision,” Mississippi Supreme Court Rules

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On February 19, 2026, the Mississippi Supreme Court ruled in Manhattan Nursing and Rehabilitation Center, LLC v. Hawkins that a wife who signed her husband’s nursing home admissions paperwork could not bind her husband to an...more

Hogan Lovells

FDA issues guidance on responding to Form 483 observations for CGMP drug inspections

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The U.S. Food and Drug Administration (FDA) published a draft guidance—the first of its kind—consolidating its expectations for how drug manufacturers should respond to Form 483 inspectional observations. The guidance applies...more

ArentFox Schiff

Competing Biomarker Providers Clash: Function Health Sues Superpower Health Over Allegedly Deceptive Advertisements

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The rapidly expanding consumer biomarker testing market — a major pillar of the longevity ecosystem — has produced its first major lawsuit between competitors....more

King & Spalding

FDA Issues Draft Guidance on Responding to FDA Form 483 Observations Following Drug Inspections

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On March 6, 2026, the Food and Drug Administration (“FDA” or “the Agency”) issued a draft guidance, “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.” The draft guidance articulates...more

Saul Ewing LLP

HIPAA Business Associate Settles with HHS OCR Following Alleged PHI Breach to the Dark Web

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On March 5, 2026, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a settlement with MMG Fusion, LLC (MMG). MMG is a Maryland software company that was the subject of a complaint...more

Polsinelli

Missouri Attorney General Files Suit Against Pharmacy Benefit Managers and Drug Manufacturers for Alleged Insulin Pricing Scheme

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Key Takeaways - The Missouri AG filed suit in St. Louis County Circuit Court against several PBMs and drug manufacturers, alleging they conspired to manipulate Missouri’s health care market and unlawfully drive up insulin...more

Alston & Bird

FDA Takes Another Step to Streamline Biosimilar Development with Expanded Use of Non-U.S.-Licensed Comparator Products

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Our FDA: Drug & Device Team explores the Food and Drug Administration’s updated draft guidance that eases biosimilar development by allowing greater use of non-U.S.-licensed comparator products in clinical studies....more

Maison Law

Wrongful Death in California Accidents: Do You Have a Claim?

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Losing a loved one to the negligence of another person is devastating, but insult is added to injury when you begin to receive expensive bills for medical expenses, the funeral and the burial. This is only the beginning...more

Holland & Knight LLP

Holland & Knight Health Dose: March 10, 2026

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No major healthcare legislation is currently scheduled for Senate floor consideration; healthcare policy activity is expected to remain concentrated at the committee level. Last week, the Senate Committee on Health,...more

Fish & Richardson

Biologics and Biosimilars Landscape 2025: IP, Policy, and Market Developments

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In Fish & Richardson’s 2025 biologics and biosimilars review, we cover Food and Drug Administration (FDA) approvals, new biosimilar launches, Biologics Price Competition and Innovation Act (BPCIA) litigation and other...more

Sheppard

A “New Era” of Consumer Medicine? FDA Takes Another Swipe at “Unapproved” Compounded Drugs

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For years, the commercial compounding and telehealth industry blossomed, buoyed by exploding consumer interest in GLP-1s and other compounded drugs. But things are changing. We recently blogged more generally about the...more

Fox Rothschild LLP

Executive Order 13 Extends Waivers for New Jersey Advanced Practice Nurses and Physician Assistants

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New Jersey advanced practice nurses (“APNs”) and physician assistants (“PAs”) have until April 2, 2026, to secure collaborating or supervising physicians before pandemic-era practice waivers expire. Healthcare practices and...more

Weintraub Tobin

Medicare Hits Pause on New DMEPOS Supplier Enrollments

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The Centers for Medicare and Medicaid Services (“CMS”) recently announced new healthcare fraud measures that include the imposition of a six-month moratorium on provider enrollments of new durable medical equipment,...more

Husch Blackwell LLP

D.C. District Court Vacates HRSA's 340B Child Site Registration Requirement

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On March 3, 2026, the U.S. District Court for the District of Columbia issued a significant decision for hospitals participating in the federal 340B Drug Pricing Program. In Albany Med Health System v. Health Resources and...more

Latham & Watkins LLP

UK MHRA Launches Consultation on Indefinite Recognition of CE-Marked Medical Devices

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The MHRA is seeking input on three proposed approaches to recognising the EU CE mark for medical devices in the UK....more

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