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Akerman LLP

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

Akerman LLP on

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

Polsinelli on

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?

Epstein Becker & Green on

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

Polsinelli on

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

Hogan Lovells

FDA Announces “plausible Mechanism” Approval Pathway for Certain Personalized Therapies, With Few Details

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Late on Wednesday, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary and Center for Biologics Evaluation & Research (CBER) Director Vinay Prasad published an article in the New England Journal of Medicine...more

Perkins Coie

New OTC Drug and Sunscreen Provisions Passed in Congress

Perkins Coie on

In the Continuing Resolution and Appropriations Package (H.R. 5371), enacted into law on November 12, 2025, Congress included several new provisions regarding over-the-counter (OTC) drug and sunscreen products....more

Eversheds Sutherland (US) LLP

Benefits Catch-Up - Q3 2025

With so much happening in the employee benefits world, we bring you Benefits Catch-Up, our catch-up contribution to help you keep up with recent developments....more

Ropes & Gray LLP

Finalized Changes to Medicare Payment Rules: Key Takeaways for Life Sciences Companies

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The Centers for Medicare & Medicaid Services (“CMS”) recently finalized a Medicare payment rule with significant implications for life sciences companies, particularly biotech and pharmaceutical manufacturers....more

McDermott+

McDermott+ Check-Up: November 14, 2025

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Government shutdown ends. President Trump signed the bill to reopen the government and reinstate expired health extenders on November 12, 2025....more

Verrill

The Proliferation of Fake Botox in the United States Draws Increased Federal Scrutiny

Verrill on

As the U.S. population ages, demand for Botulinum Toxin (“Botox”) continues to rise. The American Society of Plastic Surgeons reported that in 2022, Botox was the most commonly performed minimally invasive procedure, with 7.2...more

Benesch

Dialysis & Nephrology Digest - November 2025

Benesch on

The final rule for the 2026 Medicare Fee Schedule was released by the Centers for Medicare and Medicaid Services (CMS) on October 31, and it appears to have been finalized almost exactly as it was proposed. ...more

BakerHostetler

FDA Seeks Guidance from the Digital Health Advisory Committee on AI: Considerations for Innovators of Digital Mental Health...

BakerHostetler on

On Nov. 6, the Food and Drug Administration’s (FDA) Digital Health Advisory Committee (DHAC) convened to discuss the promise and evolving challenges of Generative Artificial Intelligence (GenAI)-Enabled Digital Mental Health...more

McGuireWoods Consulting

Government Funding: Senate Passes Three New Appropriations Bills And Continuing Resolution

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On Nov. 12, 2025, the president signed into law three appropriations bills to partially fund the government for the rest of fiscal year 2026 through Sept. 30, 2026, and a continuing resolution to fund the rest of the...more

Health Care Compliance Association (HCCA)

[Virtual Event] Healthcare Compliance Essentials Workshop - February 9th - 12th, 8:00 am - 5:00 pm CT

Kick-start your compliance education with this comprehensive workshop - HCCA’s four-day Healthcare Compliance Essentials Workshop is designed to provide foundational education on the key elements of a compliance program...more

Seyfarth Shaw LLP

The Week in Weed: November 2025 # 2

Seyfarth Shaw LLP on

Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. This week, the big story is the impending demise of the hemp industry. In addition, the state of Nebraska is feuding...more

Husch Blackwell LLP

The End of the Government Shutdown Starts a 365-day Countdown for the Hemp Industry

Husch Blackwell LLP on

On November 12, 2025, the congressional package to reopen the government was approved by both legislative chambers and has been signed into law by the president. While most of the nation breathes a collective sigh of relief,...more

Arnall Golden Gregory LLP

AGG Talks: Government Insight for Life Sciences Leaders | How Medicare Regulations Could Affect Access to Gender-Affirming Care:...

In this episode, AGG Life Sciences co-chair Alan Minsk and Healthcare partner Andrew Tsui examine how the Centers for Medicare & Medicaid Services ("CMS") may apply the Medicare Conditions of Participation ("COPs") to...more

Quinn Emanuel

The White Collar Appeal: Ninth Circuit Vacates Guilty Verdict Due to Coercive Allen Charge

Quinn Emanuel on

Background- The case involved an owner and operator of pharmacies charged with healthcare fraud and kickback charges based on alleged participation in a drug diversion scheme. Before deliberations began, the district court...more

Cozen O'Connor

Needle Little Transparency: Alabama AG Targets Research-Grade GLP-1s

Cozen O'Connor on

Alabama AG Steve Marshall obtained a temporary restraining order against Aurora IV and Wellness, an infusion clinic, and its owners in a case alleging that they administered research-grade weight loss drugs without patients’...more

Mintz - Health Care Viewpoints

Pharmaceutical Policy in Motion: Updates on the Trump Administration’s Drug Pricing Initiatives

Since May, the Trump administration has used tariffs and Most Favored Nation (MFN) drug pricing threats as a means to pressure pharmaceutical manufacturers to lower drug prices in the U.S. This pressure culminated in a...more

Wilson Sonsini Goodrich & Rosati

Senator Cassidy Introduces Sweeping Health Privacy Bill

On November 4, 2025, Sen. Bill Cassidy (R-LA) introduced the Health Information Privacy Reform Act (the Act), which would, among other things, expand the privacy protections of the Health Insurance Portability and...more

Wilson Sonsini Goodrich & Rosati

FDA Moves to Streamline Biosimilar Development: Implications for Regulatory Strategy and Clinical Study Design

The Food and Drug Administration (FDA) has issued new draft guidance signaling a policy shift toward reducing the need for comparative efficacy (CES) studies in biosimilar applications. The FDA’s approach aims to accelerate...more

Foley Hoag LLP

FDA Leadership Outlines “Plausible Mechanism” Pathway for Bespoke Therapies

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Key Takeaways: The US Food and Drug Administration (FDA) is proposing a new “plausible mechanism” pathway that will enable the limited approval of bespoke therapies when randomized trials are impractical....more

Hogan Lovells

Singapore Introduces Landmark Health Information Bill

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On 5 November the Singapore Ministry of Health introduced the Health Information Bill (the “Bill”) in Parliament, marking a major step towards achieving a centralised digital health ecosystem in Singapore. If enacted, the...more

Morgan Lewis - As Prescribed

Major Overhaul of UK Rare Disease Regulation: MHRA Proposes Enhanced Framework

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced its intention to introduce sweeping reforms for accelerating rare disease therapy development and approval, with the aim to position the UK as a...more

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