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What Life Sciences Companies Need to Know in 2025

Key Insights for Pharma Manufacturers Regarding the AKS - In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more

FDA’s Attempt to Regulate Lab-Developed Tests Struck Down in Federal Court

On March 31, a judge in the Eastern District of Texas vacated the US Food and Drug Administration’s (FDA) rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and...more

Know What You Don’t Know: What Are the Top Legal Issues Nonprofits and Associations Are Thinking Through Right Now?

The landscape is in flux right now for nonprofits, to say the least. To help structure your action plan, these are some of the top questions our Nonprofits & Associations team has been helping our clients think through....more

No More Surprise Medical Bills: Fifth Circuit Affirms Vacatur of Arbitration Provisions of Surprise Billing Rules (TMA II)

On August 2, health care providers scored yet another significant victory when the US Court of Appeals for the Fifth Circuit affirmed the vacatur of various federal regulations regarding the arbitration procedures used to...more

No More Surprise Medical Bills: Biden Administration Finalizes Rule Resetting Administrative Fees for No Surprises Act...

On December 18, 2023, the US Departments of Treasury, Labor, and Health and Human Services (the Departments) issued a rule finalizing the 2024 non-refundable administrative fee parties must pay to access the arbitration...more

No More Surprise Medical Bills: Biden Administration Issues New Surprise Billing Rulemaking Proposing Batching and Procedural...

*This is the 12th article in a series analyzing the No Surprises Act and its implementation. To view the entire series, click here. A link to the proposed rule is here.  As background, Congress passed the Act to prevent...more

FDA Seeks to Increase Regulatory Oversight of Laboratory Developed Tests

On October 3, the US Food and Drug Administration (FDA) issued a proposed rule regarding the regulation of in vitro diagnostic products (IVDs). In this proposed rule, the FDA announced its intent to amend its regulations to...more

No More Surprise Medical Bills: Biden Administration Issues New Rule Governing Arbitration Fees and Takes First Step to Restarting...

On September 21, 2023, the US Departments of Treasury (DOT), Labor (DOL), and Health and Human Services (HHS) (the Departments) issued new rulemaking governing the administrative fee required to access the arbitration process...more

No More Surprise Medical Bills: Providers Score Yet Another Victory as Texas Court Again Vacates Provisions of Biden...

On August 24, 2023, health care providers in Texas scored yet another victory when a federal court vacated additional portions of the Biden Administration’s rulemaking under the federal No Surprises Act (the Act). This marked...more

Ninth Circuit Reissues Opinion for the Second Time in Suit Challenging United Behavioral Health’s Mental Health Coverage...

Last week, the US Court of Appeals for the Ninth Circuit, in its third opinion in the case, reversed a lower court’s decision allowing patients challenging United Behavioral Health’s (UBH) internal mental health coverage...more

No More Surprise Medical Bills: In Another Victory for Providers, Texas Court Vacates Administrative Fee and Batching Provisions...

On August 3, 2023, health care providers in Texas scored yet another victory when a federal court vacated additional portions of the Biden Administration’s rules governing fee collection and claim batching under the federal...more

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