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Regulatory Requirements › Centers for Medicare & Medicaid Services (CMS) › Regulatory Authority

McGuireWoods LLP

Court Strikes Down FDA Rule Regulating Laboratory-Developed Tests

McGuireWoods LLP on

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

Bricker Graydon LLP

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

Bricker Graydon LLP on

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

Foley & Lardner LLP

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

Foley & Lardner LLP on

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

Proskauer - Health Care Law Brief on

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

Goodell, DeVries, Leech & Dann, LLP on

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

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