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Akerman LLP

From Biologics to Bandages, Skin Substitutes Are No Longer the Biologics You Think They Are...

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CMS has a skin substitute problem.   Skin substitutes are wound coverings that are used for burns, trauma, or chronic conditions like wounds associated with diabetes, leg ulcers, etc. According to the National Institutes...more

Polsinelli

3rd Quarter 2025 Analysis - Polsinelli-TrBK Distress Indices

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The Polsinelli | TrBK Distress Indices are prepared and published quarterly. The indices are contrarian measures of economic performance, and are intended to reflect the level of economic distress in the U.S. economy by...more

Polsinelli

Don’t Let The Stark Law Catch You Off Guard: Risk Remains Despite the Lull

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Key Takeaways - CMS and DOJ activity related to the Stark Law has been notably quiet in recent years, with no material rule updates since 2023 and limited enforcement actions. This slowdown has left many providers...more

DLA Piper

Supreme Court to hear First Choice Women's Resource Centers, Inc. v. Platkin

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On December 2, 2025, the United States Supreme Court will hear oral argument in First Choice Women's Resource Centers, Inc. v. Platkin, a case with significant implications for nonprofit donor privacy, First Amendment rights,...more

Mandelbaum Barrett PC

New Appellate Decision Highlights Importance of Medicaid Clinical Eligibility

Mandelbaum Barrett PC on

When most people think about Medicaid, they focus on the financial component — income and asset limits that determine eligibility. For some Medicaid programs, however, the focus needs to be on both financial and clinical...more

McDermott+

Healthcare Preview for the Week of: November 10, 2025

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On November 9, 2025, the Senate voted to proceed to consideration of a continuing resolution (CR) through January 30, 2026, that includes three full-year appropriations bills for fiscal year (FY) 2026 and additional...more

Wolf, Greenfield & Sacks, P.C.

Navigating Medical Device Regulation and IP Protection in the United States (Part 1 of 2)

In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and in some cases...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 257: Biogen’s $2B Investment in North Carolina’s RTP...

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This episode, hosts Heather and Matthew sit down with Nicole Murphy, Executive Vice President and Head of Pharmaceutical Operations and Technology at Biogen. Nicole shares why Biogen is growing in North Carolina with a $2...more

Venable LLP

Dr. Tidmarsh Resigns as Director of CDER, Leadership Developments in Key FDA Offices, and FDA Announces Reforms to Accelerate...

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Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders. ...more

Maynard Nexsen

Alabama Supreme Court Appellate Alert: Decision from November 7, 2025

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The Alabama Supreme Court issued its weekly release list on Friday, November 7, which included one opinion of interest to the Alabama business community...more

Groom Law Group, Chartered

This Week From the Hill (November 9 – 15, 2025)

Each week while Congress is in session, our Policy team delivers a key update to highlight a topical benefits, health, or retirement news item from the Hill, such as a newly introduced bill, a summary of a committee hearing,...more

Blank Rome LLP

A New Deal For GLP-1s

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The Trump Administration recently announced a multi-pronged deal with Eli Lilly and Novo Nordisk aimed at lowering the cost of GLP-1 medications used for weight loss and diabetes. While many details remain in flux, the...more

Foley & Lardner LLP

FDA Considers Drug Pricing: Leadership Cites Consumer Cost as a Driver for Changes to Biosimilar Recommendations

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“By streamlining the biosimilar development process and helping advance interchangeability, we can achieve massive cost reductions for advanced treatments for cancer, autoimmune diseases, and rare disorders affecting millions...more

Mintz - Health Care Viewpoints

Health Law Diagnosed – What California’s New Laws Mean for Health Care Investors

In this episode of Health Law Diagnosed, Of Counsel Bridgette Keller welcomes Mintz Members Daniel Cody and Deborah Daccord to unpack the latest legislative developments reshaping health care transactions in California,...more

Sheppard Mullin Richter & Hampton LLP

Patients Over Profit Act: A Federal Inflection Point on Insurer-Provider Integration and What Comes Next

For years, the conversation around health insurer consolidation and vertical integration has simmered through antitrust inquiries, oversight hearings, and policy papers. The Patients Over Profit Act (the “POP Act”),...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - December 5th, San Francisco, CA

Benefit from compliance education and networking in your area! HCCA’s Regional Healthcare Compliance Conferences offer convenient, local compliance education in a variety of locations across the country, and feature...more

Polsinelli

CMS Finalizes Sweeping Reforms to Skin Substitute Payments Amid Rising Costs and Enforcement Activity

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Key Takeaways: Major Financial and Operational Impact: On Nov. 5, 2025, CMS finalized a rule that fundamentally changes Medicare payment methodology for a broad range of skin substitute products used for wound care....more

Foley Hoag LLP - Security, Privacy and the...

Changes in the Rules for Disclosure for Substance Use Disorder Treatment Records: 42 CFR Part 2: What Changed, Why It Matters, and...

42 CFR Part 2: What Changed, Why It Matters, and What to Do Now - On November, 7, 2025, I spoke to the Massachusetts Health Information Management Association about the federal government’s sweeping updates to 42 CFR Part...more

Alston & Bird

Health Care Week in Review | CMS Announces New Drug Payment Model; Negotiations to End Government Shutdown Continue

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Mintz

[Podcast] Health Law Diagnosed – What California’s New Laws Mean for Health Care Investors

Mintz on

In this episode of Health Law Diagnosed, Of Counsel Bridgette Keller welcomes Mintz Members Daniel Cody and Deborah Daccord to unpack the latest legislative developments reshaping health care transactions in California,...more

Epstein Becker & Green

Outside Counsel’s Internal Investigations—Including Those Relating to Health Care—Are Privileged and Protected from Disclosure

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In Summer 2025, the U.S. Court of Appeals for the Sixth Circuit issued a strongly worded decision in In Re: FirstEnergy Corporation (No. 24-3654)—confirming the core concept that internal investigations conducted by counsel...more

Alston & Bird

Comparative Efficacy Studies Are No Longer the Default Requirement for Biosimilars

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Our FDA: Drug & Device Team examines the FDA’s new draft guidance that allows biosimilar developers to rely more on analytical and pharmacokinetic data, reducing the need for costly and time-consuming comparative efficacy...more

Shook, Hardy & Bacon L.L.P.

Health Care Fraud, Public Corruption in Focus in First Six Months of U.S. Attorney’s Service in Northern District of Illinois

Health care fraud, public corruption and other types of fraud have emerged as apparent top white collar enforcement priorities of the United States Attorney’s Office for the Northern District of Illinois under the leadership...more

McDermott+

McDermott+ Check-Up: November 7, 2025

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Government shutdown breaks record. As the shutdown passed the 35-day record, negotiations to reopen the government continued....more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | September 2025 Recap

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This issue of McDermott Will & Schulte’s Healthcare Regulatory Check-Up highlights regulatory activity for September 2025, including an update on the Centers for Medicare & Medicaid Services (CMS) Rural Health Transformation...more

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