Appeals, Regulatory Authority, Centers for Medicare & Medicaid Services (CMS)

Court Strikes Down FDA Rule Regulating Laboratory-Developed Tests

McGuireWoods LLP on 5/6/2025

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

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

Morgan Lewis - Health Law Scan on 4/30/2025

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

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

Husch Blackwell LLP on 4/18/2025

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

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

Bricker Graydon LLP on 4/14/2025

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

Federal District Court Vacates FDA’s LDT Final Rule

Venable LLP on 4/11/2025

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

Court of Appeals Affirms Judgment that Struck Down Rule Mandating Price Disclosure in Pharmaceutical Ads

Holland & Knight LLP on 7/6/2020

Holland & Knight's July 2019 Healthcare Law Update reported on a decision by the U.S. District Court for the District of Columbia that struck down a final rule promulgated by the U.S. Department of Health and Human Services...more