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Saul Ewing LLP

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

Saul Ewing LLP on

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

Polsinelli on

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

Alston & Bird on

Our FDA: Drug & Device Team explores the Food and Drug Administration’s updated draft guidance that eases biosimilar development by allowing greater use of non-U.S.-licensed comparator products in clinical studies....more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

Maison Law on

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

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

Sheppard on

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

Fox Rothschild LLP on

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

Weintraub Tobin on

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

Husch Blackwell LLP on

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

Latham & Watkins LLP on

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

Conn Maciel Carey LLP

Virginia Charges Ahead to Implement a Heat Illness Prevention Standard

Conn Maciel Carey LLP on

As we approach the warmer months ahead, heat illness prevention remains a top priority for regulators at both the federal and state levels. Most recently, the Virginia House of Delegates and Senate have introduced companion...more

Axinn, Veltrop & Harkrider LLP

Back to the Well: FDA’s Draft Guidance on New Clinical Investigation Exclusivity

FDA recently published a new draft Guidance for Industry titled “New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers” (Mar. 2026) (the “Draft Guidance”). The Draft Guidance...more

McDermott+

Assessing ACCESS: Opportunities and risks

McDermott+ on

CMS has released the payment amounts and performance targets for its new voluntary ACCESS model – a condition-based, outcomes-driven payment approach that could reshape how chronic care is delivered in Original Medicare....more

McDermott+

Healthcare Preview for the Week of: March 9, 2026

McDermott+ on

It will likely be a slow healthcare week in Washington, DC. The House is out of session this week, and while the Senate is in session, most of its attention will be on immigration-related hearings, pending nominations, and...more

Groom Law Group, Chartered

Second Case Regarding Prescription Drug Costs Dismissed

On March 3, 2026, a federal district court in Minnesota dismissed a lawsuit alleging that an employer imprudently managed its self-funded health plan’s prescription drug benefit, causing the plan participants to overpay for...more

Akin Gump Strauss Hauer & Feld LLP

Back to the Hive: DOJ Revisits FDCA Charges in Trade Fraud Enforcement

On February 23, 2026, Cody Matthew Herche, the head of the Department of Justice’s (DOJ) Trade Fraud Task Force created six months ago, announced that the U.S. Attorney’s Office for the Northern District of Illinois will...more

Dickinson Wright

H-1B Proclamation ‘Fee’ and Extreme Vetting Fallout: A Perfect Storm for Healthcare

Dickinson Wright on

In fiscal year 2024, approximately 8,492 H-1B visas were approved for workers in medicine and health occupations. The American Medical Association and over 50 national specialty societies and state medical associations...more

Sheppard

AI in Healthcare: What We Learned at ViVE 2026 (and What It Means for Your Organization)

Sheppard on

Sheppard’s Digital Health & Innovation Team attended the 2026 ViVE Conference in Los Angeles where healthcare innovation was on full display. Health systems, payers, and healthcare technology leaders were discussing the...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - March 2026

Latham & Watkins LLP on

Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more

Harris Beach Murtha

SCOTUS to Hear Case Regarding Induced Infringement in “Skinny Label” Case

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The U.S. Supreme Court will decide what constitutes “induced infringement” where the generic manufacturer makes statements outside approved labeling that carves out a patented use....more

Hogan Lovells

Bundling’s other test: When AKS-friendly discounts create antitrust risk

Hogan Lovells on

A recent advisory opinion from the U.S. Department of Health and Human Services Office of Inspector General (OIG) may give manufacturers more daylight to structure bundled discounts under the Discount Safe Harbor (DSH) to the...more

Hendershot Cowart P.C.

Texas Medical Board Proposes Strict New Rules for Ketamine Therapy Clinics: What Physicians Need to Know

Hendershot Cowart P.C. on

The Texas Medical Board has published proposed regulations that will fundamentally reshape how ketamine therapy clinics operate in Texas. Published in the January 2, 2026 Texas Register, these new rules under Chapter 173,...more

Loeb & Loeb LLP

In the Know: The Clean Beauty Trend Becomes State Law

Loeb & Loeb LLP on

When Congress enacted the Modernization of Cosmetics Regulation Act in 2022, MoCRA was hailed as a sweeping overhaul of the Food and Drug Administration’s cosmetic safety and quality standards. Yet, years later, MoCRA has...more

McCarter & English Blog: Government Contracts...

The BIOSECURE Act and the Expanding Life Sciences Supply Chain: Practical Considerations for Research-Driven Industries

In a previous posting, we flagged how the BIOSECURE Act (enacted as Section 851 of the Fiscal Year 2026 National Defense Authorization Act) reflects a growing focus on biotechnology supply chains within federal procurement....more

Foley & Lardner LLP

New Markets Tax Credit Financing: Subsidy for Health Care Facilities and Operations

Foley & Lardner LLP on

Enacted 25 years ago, the federal New Markets Tax Credit (NMTC) Program has become a powerful financing tool for health care organizations. Beyond simply offering tax credits to investors, the NMTC Program can provide health...more

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