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Foley Hoag LLP

Media Reports President Trump to Issue Impending Executive Order on Cannabis Rescheduling: Legal Process, Limitations, and Next...

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According to numerous media reports, President Donald Trump is strongly considering issuing an executive order directing federal agencies to resume the process rescheduling of cannabis from Schedule I to Schedule III under...more

Epstein Becker & Green

First Circuit Clarifies When Clinical Labs Can Rely on Physician Orders

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The U.S. Court of Appeals for the First Circuit recently provided important clarity—and welcome relief—for clinical laboratories facing False Claims Act (“FCA”) allegations based on a lack of medical necessity for processing...more

Loeb & Loeb LLP

Claiming Your Drug Product is Unique: Does That Mean It's Superior?

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Brands and marketers seek to highlight what makes their products singular and unique. But it can be very challenging to do so in a manner that does not imply superior efficacy — particularly when evidence of superiority is...more

Epstein Becker & Green

Understanding the False Claims Act Statute of Limitations—and the Debate Over the “Last Overt Act” Rule

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The False Claims Act (FCA) is one of the federal government’s most powerful tools for combatting healthcare fraud. Yet, as with any enforcement tool, its reach is constrained by a statute of limitations....more

Morgan Lewis

Eleventh Circuit Considers Constitutionality of the False Claims Act’s Qui Tam Provisions

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On December 12, 2025, an Eleventh Circuit panel heard oral argument in a closely watched Justice Department and relator appeal of a 2024 Middle District of Florida opinion finding the qui tam provisions of the False Claims...more

Mayer Brown

One Big Beautiful Bill Act, Part 2: Leveraging “Trump Accounts” for Financial Wellness, Benefit Plan Design, and Health Savings...

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Join us for this three-part series covering how the One Big Beautiful Bill Act reshapes the workplace benefits conversation. This series features Hillary August, Stephanie Vasconcellos, and Ryan Liebl who provide insight into...more

Verrill

Seven Swans A-Swimming… and Staying Above Water on Sick Leave Compliance

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Managing employee time away from work shouldn’t be complicated—but without a thoughtful framework, paid sick leave, family and medical leave, short-term disability, and accommodation obligations intersect in ways that make...more

Akin Gump Strauss Hauer & Feld LLP

FDA’s TEMPO Pilot Seeks to Expand Access to Chronic Disease Technologies in CMS Collaboration

On December 5, 2025, FDA announced its Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a new voluntary pilot that seeks to accelerate innovation and expand access to digital health...more

Knobbe Martens

Abbott to Expand Its Cancer Diagnostic Segment

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Abbott recently announced that it agreed to acquire Exact Sciences for approximately $21 billion to enter the fast-growing cancer diagnostic segment. Under the terms of the agreement, Abbott will acquire all outstanding...more

Cooley LLP

Will TEMPO Accelerate Your Market ACCESS and Reimbursement? FDA’s New Pilot Program Offers Enforcement Discretion for Certain...

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In a move aimed at tying reimbursement to patient outcomes, the Centers for Medicare & Medicaid Services (CMS) Innovation Center announced the “Advancing Chronic Care with Effective Scalable Solutions” (ACCESS) model, a...more

McDermott Will & Schulte

Strategic defenses and the “silence option” in the CY 2026 OPPS drug cost survey

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While much of the industry’s attention on the calendar year (CY) 2026 Hospital Outpatient Prospective Payment System (OPPS) final rule has focused on immediate payment cuts, a more complex challenge lies in the finalized OPPS...more

Troutman Pepper Locke

“All Foam and No Beer:” First Circuit Shields Lab From Relator’s Ginned-Up FCA Case

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The U.S. Court of Appeals for the First Circuit has weighed in on Omni Healthcare, Inc.’s (Omni) False Claims Act (FCA) allegations against MD Labs, issuing a decisive win for the defendant. On December 1, 2025, a unanimous...more

Groom Law Group, Chartered

A Big, Beautiful Break for HSAs: IRS Guidance on the One Big Beautiful Bill Act’s HSA Provisions

On December 9, 2025, the IRS issued Notice 2026-05, which provides guidance on the HSA provisions in the One Big Beautiful Bill Act (“OBBB”). The Notice provides much-anticipated guidance right before many of these provisions...more

Maynard Nexsen

Trump’s Executive Order on AI and the Potential Impact on State Healthcare Laws Governing AI

Maynard Nexsen on

President Trump’s new executive order on artificial intelligence (“AI”) seeks to impose broad and strict impediments to state-level regulation of AI. Signed on December 11, 2025, the order establishes a “minimally burdensome...more

Jones Day

FDA's Support for Onshoring Drug Manufacturing and Increasing Oversight of Foreign Facilities

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Since 2000, pharmaceutical manufacturing has increasingly moved offshore. Today, approximately 53% of brand drug products and 69% of generics have at least one manufacturer outside the United States. Additionally, the United...more

Quarles & Brady LLP

Countdown to 2026: New Year Changes in Telehealth Impacting Medicare Providers

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The manner in which services are provided via telehealth has the potential to look very different for healthcare providers—particularly those providing services to Medicare patients—in 2026. As 2025 draws to a close, the...more

Rivkin Radler LLP

Electronic Visit Verification (EVV): The New Frontier in Home Health Fraud Enforcement

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The 21st Century Cures Act (“Cures Act”) required states to adopt electronic visit verification (EVV) systems for Medicaid-covered personal care services (“PCS”) by January 1, 2020 and for home health care services (“HHCS”)...more

Jones Day

Commissioner's National Priority Voucher Program and Coverage Considerations

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On June 17, 2025, FDA Commissioner Marty Makary launched a new priority review pilot program intended to accelerate FDA review for drug and biologic companies supporting U.S. national interests. Specifically, the...more

ArentFox Schiff

Investigations Newsletter: DOJ Once Again to Corporate Community: White Collar Criminal Enforcement Not Slowing Down

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DOJ Once Again to Corporate Community: White Collar Criminal Enforcement Not Slowing Down - On December 9, at the Practising Law Institute White Collar Crime symposium in New York City, New York, Acting Chief Counselor of...more

ArentFox Schiff

Staying on TEMPO: Five Things for Digital Health Companies to Know About the FDA’s New Pilot

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Federal regulators are taking a coordinated step to accelerate the responsible integration of digital health technologies into routine care....more

Troutman Pepper Locke

Colorado Law Adopting Uniform Utilization Review Standards for Behavioral Health Treatment Goes into Effect January 1, 2026

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Colorado House Bill 25-1002, effective January 1, 2026, amends Colorado Revised Statutes § 10-16-104(5.5) to require health benefit plans to use nationally recognized, not-for-profit clinical criteria when making coverage and...more

Epstein Becker & Green

The Next Chapter of Medicare Advantage and Part D: Key Takeaways from the 2027 Proposed Rule

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On November 25, 2025, the Centers for Medicare & Medicaid Services (CMS or the “Agency”) released the 2027 Medicare Advantage and Part D Proposed Rule (the “Proposed Rule”)....more

Hogan Lovells

EU Pharma Law Package: Council and Parliament Reach Agreement

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On 11 December 2025, the Council and the European Parliament reached agreement on the EU Pharma Law Package, also known as the General Pharmaceutical Legislation. No text has been published yet. The agreement will need to be...more

Gordon Rees Scully Mansukhani

Colorado’s Evolving Malpractice Damages Framework: Legislative Increases and Supreme Court Guidance

The landscape surrounding Colorado’s healthcare malpractice damage caps continues to shift. Earlier this year, the Colorado General Assembly enacted wholesale changes to the Health Care Availability Act (HCAA). These changes...more

Morgan Lewis - ML Benefits

Clearing the Smoke: Insights from the Williams v. Bally’s Tobacco Use Surcharge Dismissal

In Williams v. Bally Management Group, LLC, the US District Court for the District of Rhode Island became the first court to grant a motion to dismiss in a class action challenging Bally Management Group’s (Bally) tobacco...more

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