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Hogan Lovells

When Culture Outpaces Compliance: A Wake-Up Call for US Medical Device Manufacturers

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In the labyrinthine world of medical device manufacturing, process is king—but culture wears the crown. Peter Drucker's adage, “Culture eats strategy for breakfast,” has long echoed through boardrooms, but within regulated...more

Foley Hoag LLP

CMS Announces ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model

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Key Takeaways: The ACCESS Model1 tests an outcome-aligned payment (OAP) approach designed to give people with Original Medicare new options to improve their health and prevent and manage chronic disease with...more

Hogan Lovells

Milestone US-UK Drug Tariff and Pricing Deal Announced

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The U.S. and UK have announced a pharmaceutical tariff and pricing deal in which the UK government agreed to increase investment in innovative medicines, and U.S. President Trump agreed to exempt the UK from certain...more

Phelps Dunbar

Heads Up for Health Care Professionals: AI Tools Could Be a Legal Minefield

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AI is changing the game in patient care. From wearable sensors that track vitals to predictive alerts that flag early signs of deterioration, these tools are helping clinicians intervene faster and smarter. But here’s the...more

Dentons

Ep. 89 – Three Red Flags to Watch for to Lower Your False Claims Act Risk

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In a recently settled False Claims Act case, the Department of Justice (DOJ) highlighted several alleged practices that offer important lessons for compliance professionals. While the case settled with no admission of...more

Haynes Boone

MoCRA Update: FDA Withdraws Proposed Talc Rule, Citing MAHA Priorities and Testing Complexities

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On November 28, 2025, while most cosmetic companies were promoting their “Black Friday” deals for this year, the FDA quietly issued a Federal Register notice withdrawing the Agency’s previously proposed regulation for...more

Epstein Becker & Green

Brand Licensing in Health Care: An Overview for Hospitals

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Imagine this scenario: a longtime patient at an ENT practice decides to leave the traffic and sprawl of a major metropolitan area for a more idyllic, rural existence elsewhere in the state....more

Epstein Becker & Green

FDA Proposal Would Extend Food Traceability Rule’s Compliance Deadline to July 2028

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The federal government is back in business, and those who may be scrambling to comply with the January 20, 2026, deadline for the Food and Drug Administration’s (“FDA” or the “Agency”)  Food Traceability Rule (“FTR” or “Final...more

Fisher Phillips

Court Tosses Most Claims in Healthcare Pixel Privacy Suit, Ruling That Website Visits Don’t Reveal PHI: What Your Business Should...

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A California federal court recently handed healthcare businesses another victory in the ongoing wave of privacy lawsuits targeting website analytics and tracking tools. A California federal judge ruled on November 21 that...more

McDermott+

Healthcare Extenders Tracker (December 2025 Update)

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Many healthcare programs are extended for specific time periods, as short as one or two years or as long as 10, and are usually attached to a larger piece of must-pass legislation....more

McDermott+

CMS releases 2027 policy and technical changes to Medicare Advantage and Part D proposed rule

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On November 25, 2025, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that puts forth policy and technical changes to the Medicare Advantage (MA) and Part D programs for 2027 and beyond....more

McDermott+

The 2027 MA and Part D proposed rule: What’s in and what’s out

McDermott+ on

Last week, right before you enjoyed your Thanksgiving feast, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule that lays out policy and technical changes to the Medicare Advantage (MA) and Part D...more

Holland & Knight LLP

Holland & Knight Health Dose: December 3, 2025

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Following a brief Thanksgiving holiday break, U.S. Congress faces just a handful of legislative days before year-end, and the next two weeks promise a crowded calendar as lawmakers race to meet major deadlines....more

Knobbe Martens

USPTO’s Automated Search Pilot: Through a Biotech Lens

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In October 2025, the U.S. Patent and Trademark Office (USPTO) launched the “Artificial Intelligence Search Automated Pilot Program,” or ASAP!, an initiative to identify potential prior art using artificial intelligence (AI)...more

Benesch

CMS Announces New ACCESS Model, Advancing a National Outcomes-Based Framework for Chronic Care, Health Equity and Community...

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The Centers for Medicare & Medicaid Services (“CMS”), through the CMS Innovation Center (“CMMI”), has announced the ACCESS Model—Advancing Clinical Care, Equity and System Sustainability, a national demonstration model...more

Latham & Watkins LLP

New Health Data Lab in Germany Facilitates Secondary Use of Health Data

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In the current interconnected health research ecosystem, comprehensive and secure access to health data is key to accelerate drug discovery and improve patient outcomes. ...more

Fox Rothschild LLP

New California Laws Reshape Healthcare Transactions and Investor Influence

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In October 2025, Governor Gavin Newsom signed two sweeping laws that significantly reshape how healthcare transactions are reported and how private equity groups and hedge funds may engage with physician and dental practices....more

McCarter & English, LLP

HHS/CMS Repeals Minimum Staffing Standards for Long-Term Care Facilities

On December 3, 2025, the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) published an interim final rule (the 2025 Interim Rule) that repeals certain provisions of the...more

Environmental General Counsel PC

The EU's Chemical Strategy is Reshaping Beauty and Fragrance Regulation

Regulatory pressures in the European Union are rapidly reshaping the landscape for cosmetics and fragrance companies. New hazard classes under the CLP Regulation, early national classification proposals, and forthcoming...more

Jones Day

FDA's Biosimilar Playbook: Merging Biosimilarity with Interchangeability

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The Food and Drug Administration ("FDA") issued two draft guidance documents that would largely eliminate clinical efficacy and switching studies and instead rely on the precision of modern analytical methods to accelerate...more

Rivkin Radler LLP

Diagnostic Lab to Pay $9.6 Million to Settle FCA/AKS Allegations

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The U.S. Department of Justice recently announced a settlement with Patients Choice Laboratories (“PCL”), a diagnostic laboratory headquartered in Indianapolis, Indiana, under which PCL will pay over $9.6 million to resolve...more

Benesch

CMS Finalizes Mandatory Ambulatory Specialty Model for Heart Failure and Low Back Pain Specialists

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On October 31, 2025, the Centers for Medicare & Medicaid Services (CMS) finalized the Ambulatory Specialty Model (ASM) in the CY 2026 Medicare Physician Fee Schedule (PFS) final rule. ...more

Troutman Pepper Locke

States Tighten Oversight of Private Equity in Health Care

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Private equity’s footprint in health care has expanded rapidly over the past decade, and in response states have begun to retool long‑standing doctrines and create new guardrails that target ownership, control, and...more

Seyfarth Shaw LLP

Agencies Release 2026 Out-of-Pocket Limits and 2025 Limits for Health FSAs  

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Recently the IRS issued Rev. Proc. 2025-32 and 2025-61, announcing the cost-of-living adjustments to certain welfare and fringe benefit plan limits for 2026 and applicable dollar amounts for the remainder of 2025. 2026...more

Roetzel & Andress

Holiday Gifts in Healthcare: Are You Breaking the Rules?

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On this episode of the #HealthLawHotspot, host Ericka Adler is joined by Roetzel shareholder Christina Kuta to break down what healthcare providers need to know about holiday gift giving. They explain how federal and state...more

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