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Hogan Lovells

FDA to rescind laboratory developed test rule

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FDA decided to rescind the LDT rule after declining to appeal a district court decision vacating it. The rule reflected FDA’s latest attempt to regulate LDTs under the same framework as IVDs, which FDA considers medical...more

McGuireWoods LLP

Court Strikes Down FDA Rule Regulating Laboratory-Developed Tests

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On March 31, 2025, the U.S. District Court for the Eastern District of Texas, in American Clinical Laboratory Association v. U.S. Food and Drug Administration, vacated the U.S. Food and Drug Administration’s (FDA’s) May 6,...more

Morgan Lewis - Health Law Scan

Courts Diverge in Challenges to CMS's Minimum Staffing Requirements for LTC Facilities

On May 10, 2024, the Centers for Medicare and Medicaid Services (CMS) published its Final Rule to implement minimum staffing standards for long-term care (LTC) facilities in the United States. However, as discussed in our...more

Mintz - Health Care Viewpoints

Deregulatory Push by Trump Administration Picks Up Speed

It’s no secret that President Trump, his Cabinet, and other executive branch leaders are prioritizing deregulatory activities over more historical federal governance approaches. Indeed, one of President Trump’s earliest...more

Husch Blackwell LLP

Federal Court Vacates FDA's Final Rule on Laboratory-Developed Tests

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On March 31, 2025, the Eastern District of Texas issued a decision in the case brought by the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP), challenging the FDA’s final rule...more

Arnall Golden Gregory LLP

Court Strikes Down Nursing Home Minimum Staffing Rule

On April 7, 2025, the United States District Court for the Northern District of Texas ruled in favor of the American Health Care Association (“AHCA”) in its lawsuit against Health and Human Services (“HHS”) Secretary Robert...more

Proskauer - Health Care Law Brief

Post‑Chevron Spotlight: Federal Court Nixes FDA Rule Reclassifying Laboratory Services as Medical Devices

In another rebuke to federal regulatory overreach, the U.S. District Court for the Eastern District of Texas (“District Court”) has vacated the Food and Drug Administration’s (“FDA”) 2024 final rule that sought to bring...more

Bricker Graydon LLP

CMS Final Rule on Minimum Staffing Standards for Long-Term Care Facilities Struck Down

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On April 7, 2025, the United States District Court for the Northern District of Texas vacated staffing requirements published in the Centers for Medicare & Medicaid Services (CMS) May 2024 Minimum Staffing Rule (the “Final...more

Venable LLP

Federal District Court Vacates FDA’s LDT Final Rule

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On March 31, 2025, the U.S. District Court for the Southern District of Texas vacated the FDA’s Final Rule on laboratory-developed tests (LDTs), holding that the agency lacks authority to regulate LDTs as medical devices...more

ArentFox Schiff

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

ArentFox Schiff on

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

Faegre Drinker Biddle & Reath LLP

Laboratory-Developed Tests (LDTs) Do Not Qualify as ‘Devices’ Under the Food, Drug and Cosmetic Act

On March 31, 2025, in the U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration’s (FDA) final rule, in which FDA attempted to assert regulatory authority over laboratory-developed...more

Wilson Sonsini Goodrich & Rosati

FDA’s LDT Final Rule Rejected by Federal District Court in Texas

As Wilson Sonsini previously reported,1 the U.S. Food and Drug Administration (FDA) had been preparing the industry to comply with the 2024 LDT Final Rule, which phases out the FDA’s enforcement discretion policy for...more

Foley & Lardner LLP

Texas Court Vacates FDA’s Laboratory Developed Test (LDT) Final Rule

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A Texas judge for the U.S. District Court for the Eastern District of Texas issued a ruling on March 31, 2025, to vacate and set aside, in its entirety, the U.S. Food and Drug Administration’s (FDA) Final Rule titled Medical...more

Proskauer - Health Care Law Brief

HHS Scraps Richardson Waiver, Clearing Way for Faster Rulemaking

On March 3, 2025, the United States Department of Health and Human Services (“HHS”) issued a policy statement rescinding the Richardson Waiver, a policy in place since 1971 that required notice-and-comment rulemaking for...more

Goodell, DeVries, Leech & Dann, LLP

Understanding CMS “Immediate Jeopardy” Investigations in Healthcare Facilities

When it comes to ensuring patient safety, healthcare facilities operate under a complex regulatory framework, including oversight from the Centers for Medicare & Medicaid Services (CMS). One of the more intense processes CMS...more

Holland & Knight LLP

OCR Shores Up Access to Healthcare with Nondiscrimination Protections

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Access to quality healthcare services has long been a priority of the U.S. Department of Health and Human Services (HHS), and through its Office for Civil Rights (OCR) this agency has, since at least 2001, sought to provide...more

Burr & Forman

Federal Agency Deference Eliminated, Now What?

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On June 28, 2024, the U.S. Supreme Court issued a decision that overrules the “Chevron doctrine.”  This means that federal agencies are limited in their ability to rely on their own interpretation of the laws they...more

Holland & Knight LLP

What's Next for the Regulatory Landscape Post-Chevron?

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For nearly 40 years and in more than 18,000 judicial opinions, federal courts have used the Chevron doctrine to defer to an agency's reasonable interpretation of an ambiguous statute. On June 28, 2024, the U.S. Supreme Court...more

Baker Donelson

60 Days After Loper: Health Care Impact of Chevron Deference's End

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The Supreme Court of the United States issued its highly anticipated ruling in a pair of cases challenging the long-standing Chevron doctrine on June 28, 2024. Foreshadowed by decisions in recent years slighting Chevron, it...more

Parker Poe Adams & Bernstein LLP

Two Recent Supreme Court Decisions Could Dramatically Impact Health Care Regulatory Challenges at the Federal and State Levels

For nearly 40 years, federal courts have been required to defer to an agency’s interpretation of an ambiguous statute, even if the court did not agree with that interpretation. This deference, commonly referred to as Chevron...more

Polsinelli

Top Questions Health Care Providers Should Consider in a Post-Chevron World – A Polsinelli Round Table Discussion

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Health Care is one of the most regulated industries in the country, and for many years, one of the key administrative agencies overseeing health care in the United States, the Department of Health and Human Services’ (“HHS”)...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 3, July 2024

Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more

Schwabe, Williamson & Wyatt PC

Supreme Court decision overturning Chevron could have huge implications for health care

The recent U.S. Supreme Court decision overturning the Chevron Doctrine, which curtailed the power of the federal agencies to interpret the laws they administer, could prove to be disruptive in the health care realm, said two...more

Husch Blackwell LLP

The Overturning of Chevron Deference: Implications for AI in Medical Research

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In a landmark decision on June 28, 2024, the Supreme Court overturned a 40-year-old legal precedent known as Chevron deference. Established in 1984, Chevron deference mandated that judges defer to federal agencies concerning...more

Stotler Hayes Group, LLC

The (Potential) Bright Side of Loper Bright for the Long-Term Care Industry

On June 28, 2024, the Supreme Court made a sharp about-face from a doctrine that has governed administrative law for decades, overruling the “Chevron deference” doctrine with its decisions in Loper Bright Enterprises v....more

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