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McDermott Will & Schulte

Inside HPE Europe 2025 | European healthcare investment in 2026: Outpatient services, optimisation, and optimism

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As macro trends such as population growth, ageing demographics, and co-morbidities place increasing pressure on healthcare systems, investors are once again seeking out compelling opportunities in the healthcare services...more

McDermott+

Trump Administration Executive Order Tracker - November 2025

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Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more

McDermott Will & Schulte

Joint Commission announces key accreditation updates for 2026

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The Joint Commission (JC) is evolving its accreditation program and, among other programmatic changes, has announced two major initiatives effective January 1, 2026: the launch of its Accreditation 360 model, including an...more

McDermott Will & Schulte

Inside HPE Europe 2025 | Deal flow on the rise: Financing healthcare and life sciences in 2026

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It has been a busy year for European financing markets, with robust demand for refinancings driving volume. The fourth quarter of 2025 likely will see more transactions coming to market in preparation for an even livelier...more

DLA Piper

The legal journey of food supplements: From product development to marketing and market surveillance - Part 2

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The food supplement market in Germany is growing rapidly, fuelled by health trends, an ageing population, innovative online marketing and direct-to-consumer brands. This dynamic environment has also driven strong M&A...more

Cozen O'Connor

The State AG Report – 11.13.2025

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Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Needle Little Transparency: Alabama AG Targets...more

Goodwin

New FDA Guidance Aims to Simplify the Biosimilar Approval Process

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In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein products. ...more

Troutman Pepper Locke

IRS Announces 2026 Retirement Plan Limits: Modest Increases

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The Internal Revenue Service (IRS) announced the 2026 cost-of-living adjustments to the dollar limitations for qualified retirement plans and other benefits, and the Social Security Administration announced its own...more

Stark & Stark

New Research Shows Mild Traumatic Brain Injury Symptoms Can Persist for Years

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For many years, patients who sustained a mild traumatic brain injury, often referred to simply as a concussion, were told that their symptoms should resolve within a few weeks or months. ...more

Venable LLP

Hikma Announces Launch of Stelara® (ustekinumab) Biosimilar Starjemza™

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On November 6, 2025, Hikma announced the U.S. launch of Starjemza™ (ustekinumab-hmny), a biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab).  Starjemza™ is approved for all the reference product’s indications,...more

BakerHostetler

No Opting-Out: Navigating the Uncharted Waters of Medicare’s Ambulatory Specialty Model (ASM)

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On Oct. 31, the Centers for Medicare & Medicaid Services (CMS) released the 2026 Medicare Physician Fee Schedule Final Rule, wherein it established the Ambulatory Specialty Model (ASM) – a mandatory alternative payment model...more

Hogan Lovells

CMS announces voluntary “GENEROUS” Medicaid most-favored-nation drug pricing model, planned to launch in 2026

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On November 6, 2025, the Centers for Medicare & Medicaid Services (CMS) announced a new drug payment model designed to make Most Favored Nation (MFN)-level prices available to state Medicaid programs via manufacturer rebates....more

Rivkin Radler LLP

NYS Cracks Down on Medical Transportation Companies for Fraud

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In October, two medical transportation companies were charged with or indicted for fraud in New York. The owner of Pearl Transit Corp. (“Pearl”), Jael Watts, was accused of running a sham transportation service that...more

Health Care Compliance Association (HCCA)

[Event] Managed Care Compliance Conference - February 2nd - 3rd, Chandler, AZ

Insight, innovation, and practical strategy for professionals in the managed care space - Compliance professionals in managed care face an ever-changing landscape shaped by evolving regulations, emerging risks, and...more

Hogan Lovells

Revised pre-RFD guidance reflects FDA’s efforts to clarify pre-RFD process

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The U.S. Food and Drug Administration (FDA) recently revised its final guidance, How to Prepare a Pre-Request for Designation (Pre-RFD). ...more

DLA Piper

Life Sciences New in Italy: October 2025

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Regulatory - European Commission adopts rules for joint clinical assessments of medical devices and in vitro diagnostic medical devices - On 17 October 2025, the European Commission (EC) adopted Implementing Regulation...more

Sheppard Mullin Richter & Hampton LLP

Navigating Healthcare Workforce Shortages: Evolving Scope-of-Practice and Staffing Regulations

Persistent workforce shortages continue to define the post-pandemic healthcare landscape. Hospitals, health systems, and long-term care providers report enduring deficits in nursing, primary care, and behavioral health...more

Stevens & Lee

2026 Deadline Looms for Compliance with Updated Part 2 Regulations Regarding Patient Data Protections

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We previously detailed the U.S. Department of Health and Human Services’ significant modifications to 42 C.F.R. Part 2 (Part 2) in Feb. 2024 applicable to organizations that handle substance use disorder (SUD) treatment...more

Chambliss, Bahner & Stophel, P.C.

Understanding ABLE Accounts: What They Are and How They Work

For individuals with disabilities and their families, saving for the future has long presented unique challenges due to the asset limits tied to essential government benefits. ABLE accounts — tax-advantaged savings accounts...more

Neal, Gerber & Eisenberg LLP

2026 Game Plan for Group Health Plans

I. Scouting Report: How We Got to 2026 - Several federal updates issued in 2024–2025 take effect in 2026. This section highlights the developments that drive the 2026 adjustments....more

Seward & Kissel LLP

Bonvoy-age Sonder and Purdue Conphirmation

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Airbnb rival Sonder Holdings to file for bankruptcy after Marriott ends partnership | Business Insider - Guests were ejected from ongoing bookings as Marriott made the announcement on Sunday....more

Akerman LLP

Congress Enacts Sweeping Recriminalization of Hemp-Derived THC Products in Federal Spending Bill Ending Government Shutdown

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On November 12, 2025, President Donald Trump signed into law the government funding package (H.R. 5371), ending the longest government shutdown in U.S. history — and, in doing so, enacted the most consequential federal change...more

Polsinelli

Courts Renew Scrutiny of the False Claims Act’s Qui Tam Provisions

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Key Takeaways - Courts Revisit the Constitutionality of the FCA: Recent federal decisions reflect renewed judicial scrutiny of the False Claims Act’s qui tam provisions, which authorize private individuals to bring...more

Epstein Becker & Green

DOJ Subpoena Seeks Health Information of Hospital Patients Receiving Gender-Affirming Care: Will Judge Grant Motion to Quash?

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On June 12, 2025, the Children’s Hospital of Philadelphia (“CHOP”) received a subpoena issued by the Department of Justice (“DOJ”) requesting highly sensitive patient health and procedure information related to...more

Polsinelli

CMS Expands Consequences of Medicare Revocation: What You Need to Know

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Key Takeaways - CMS maintains its authority to impose Medicare reenrollment bars: CMS emphasizes its ability to apply reenrollment bars when a provider’s Medicare billing privileges are revoked, affecting all enrollments...more

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