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McGuireWoods Consulting

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

McGuireWoods Consulting on

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

Foley Hoag LLP on

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

Hogan Lovells on

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

Dentons

Ep. 87 – Three Mistakes to Avoid in Physician Agreements

Dentons on

Most physicians and the providers to whom they make referrals understand the importance of complying with the Stark Law as well as how costly non-compliance can be. However, many providers are often surprised to learn that...more

McDermott+

What to expect (from CMS) when you’re expecting (an end to the government shutdown)

McDermott+ on

The end of the longest government shutdown in US history is finally here, with the president having signed a continuing resolution (CR) that funds the government through January 30, 2026....more

Hanson Bridgett

New California Law Will Allow Physicians to Supervise More Physician Assistants

Hanson Bridgett on

Effective January 1, 2026, a new law — Assembly Bill 1501 — will amend Section 3516 of the California Business and Professions Code to allow physicians to supervise up to eight physician assistants (PAs) at any one time in...more

Bradley Arant Boult Cummings LLP

CMS Tests Prior Authorization for Ambulatory Surgery Centers: Preparing for the 2025 Demonstration

CMS is launching a five-year Prior Authorization Demonstration for certain ambulatory surgical center (ASC) services beginning December 15, 2025, in 10 states, including Georgia, Florida, Tennessee, and Texas....more

Bass, Berry & Sims PLC

Health Care Investors Conference: 2025 Recap

Bass, Berry & Sims PLC on

Bass, Berry & Sims hosted the 15th annual Health Care Investors Conference (HCIC), co-sponsored by Deloitte, Gallagher and Houlihan Lokey, on October 29. Each year HCIC brings together hundreds of leading health care industry...more

McDermott Will & Schulte

IRS announces 2026 employee benefit plan limits

McDermott Will & Schulte on

The Internal Revenue Service (IRS) has announced the cost-of-living adjustments to the applicable dollar limits for various employer-sponsored retirement and welfare plans for 2026....more

Epstein Becker & Green

42 CFR Part 2 Final Rule: What’s Changing and What Do You Need to Know? – Diagnosing Health Care Video Podcast

Epstein Becker & Green on

By early 2026, substance use disorder (SUD) providers, health plans, clinicians, health information exchanges (HIEs), and vendors must meet new federal privacy standards for SUD treatment records or face Health Insurance...more

White & Case LLP

Market context: Regulatory volatility meets deal resilience

White & Case LLP on

The third quarter of 2025 closed amid growing macroeconomic strain, policy unpredictability and renewed investor focus on execution risk. While deal volume in life sciences and healthcare private capital has stabilized after...more

Troutman Pepper Locke

CY 2026 Medicare Physician Fee Schedule: What Payors and Insurers Need to Know

Troutman Pepper Locke on

On October 31, CMS finalized the CY 2026 Medicare Physician Fee Schedule (PFS) rule (CMS-1832-F), effective January 1, 2026. While primarily directed at Medicare providers, the rule’s changes have clear downstream effects for...more

Wiley Rein LLP

FDA Seeks to Accelerate Biosimilar Development by Easing Data Requirements

Wiley Rein LLP on

The U.S. Food and Drug Administration (FDA) significantly revised its approach to biosimilar drug development on October 29. Specifically, FDA issued a draft guidance recommending when comparative analytical assessments (CAA)...more

ArentFox Schiff

CMS Issues 2026 Physician Fee Schedule Final Rule: Key Takeaways for Pharma

ArentFox Schiff on

On October 31, the Centers for Medicare & Medicaid Services (CMS) issued a final rule announcing changes for Medicare payments under the Physician Fee Schedule (PFS), effective on or after January 1, 2026....more

Mitchell, Williams, Selig, Gates & Woodyard,...

Interpretation of the General Duty Clause/Limitation for Inherently Risky Professional Activities: 16 State Attorney Generals...

The Commonwealth of Pennsylvania’s Department of Labor & Industry and 16 other state Attorney Generals and/or labor departments collectively submitted November 1st comments to the Occupational Safety and Health Administration...more

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