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Final Rules Vacated Centers for Medicare & Medicaid Services (CMS)

King & Spalding

Texas Court Strikes Down Key Portions of Biden-Era Rule Imposing Minimum Nurse Staffing Requirements at Nursing Homes

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On April 7, 2025, Judge Matthew Kacsmaryk of the Northern District of Texas vacated two provisions of a major 2024 CMS nurse staffing regulation requiring nursing homes to have an RN on site 24 hours a day, 7 days per week...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

Baker Donelson

Federal Court Vacates LDT Final Rule

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The U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration's (FDA) final rule on March 31, 2025, under which the FDA would have started regulating most laboratory-developed tests (LDTs)...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

Venable LLP

Federal District Court Vacates FDA’s LDT Final Rule

Venable LLP on

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

Sheppard Mullin Richter & Hampton LLP

LDT Final Rule Series: Part 4 – Rule Overturned by Federal District Court

Last Monday, the U.S. District Court for the Eastern District of Texas (the “District Court”) issued a highly anticipated – and unsurprising – opinion invalidating the U.S. Food & Drug Administration’s (“FDA’s” or the...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

King & Spalding

The Fifth Circuit Affirms Decision Vacating CMS Regulations Implementing the No Surprises Act IDR Process

King & Spalding on

On August 2,2024, the Fifth Circuit affirmed the vacatur of federal rulemaking related to the No Surprises Act’s (NSA) Independent Dispute Resolution (IDR) process. The Court held that the No Surprises Act does not permit the...more

ArentFox Schiff

No More Surprise Medical Bills: Texas Court Again Vacates Arbitration Provisions of Surprise Billing Rule

ArentFox Schiff on

On February 6, 2023, health care providers scored a second significant victory when a federal court in Texas again vacated portions of the Biden Administration’s rules governing the arbitration procedures to resolve surprise...more

Bass, Berry & Sims PLC

Federal District Court Vacates Copay Accumulator Adjustment Rule: Programs Remain the Same for Now

Bass, Berry & Sims PLC on

On May 17, the U.S. District Court for the District of Columbia issued a decision vacating the Accumulator Adjustment Rule, regulations issued by the Centers for Medicare and Medicaid Services (CMS) in December 2020 as part...more

Sheppard Mullin Richter & Hampton LLP

Fifth Circuit Upholds ACA Risk Adjustment Program

Various smaller health insurance issuers have challenged the risk-adjustment program under the Patient Protection and Affordable Care Act (ACA), alleging, among other things, that its underlying methodology favors larger...more

ArentFox Schiff

DC District Court Judge Rules Against CMS’s Site-Neutral Policy, Vacates CY 2019 Outpatient Prospective Payment System (OPPS)...

ArentFox Schiff on

On September 17, 2019, the US District Court for the District of Columbia ruled in American Hospital Association, et al. v. Alex Azar, II, et al that the Centers for Medicare & Medicaid Services (CMS) exceeded its statutory...more

Sheppard Mullin Richter & Hampton LLP

D.C. District Court Vacates CMS Final Rule, Finds that CMS’ Lesser Reimbursement of Services Provided at Grandfathered Off-Campus...

On September 17, 2019, the U.S. District Court for the District of Columbia ruled against the Centers for Medicare and Medicaid Services (“CMS”), vacating CMS’ 2018 Final OPPS Rule, which cut Medicare reimbursement rates for...more

Jones Day

D.C. District Court Vacates 60-Day Medicare Advantage Overpayment Rule

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The Situation: In 2016, several Medicare Advantage ("MA") organizations challenged a 2014 final rule promulgated by the Center for Medicare Services ("CMS") that broadly subjected MA organizations to potential liability under...more

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