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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

Dinsmore & Shohl LLP

Stringent Federal Staffing Requirements for Skilled Nursing Facilities No Longer in Play

Dinsmore & Shohl LLP on

On April 7, 2025, a Federal District Court in Texas vacated the controversial Centers for Medicare and Medicaid Services (“CMS”) proposal to require specific staffing requirements in skilled nursing facilities (“SNFs”).[1]...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

Faegre Drinker Biddle & Reath LLP

Federal Court Strikes Down CMS Nursing Home Staffing Mandate

Background - On April 7, 2025, the U.S. District Court for the Northern District of Texas vacated key provisions of CMS’s final rule establishing minimum staffing requirements for long-term care facilities. The rule would...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

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

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

King & Spalding

Federal Judge Vacates Regulation Excluding Section 1115 Days From DSH Formula

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On August 15, 2024, the United States District Court for the Northern District of Texas vacated a Medicare regulation excluding from the Medicare DSH payment days attributable to inpatients covered by a section 1115 waiver...more

King & Spalding

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

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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

Proskauer - Health Care Law Brief

The Supreme Court’s Ruling Narrows Available FCA Scienter Defenses

In a unanimous opinion, the United States Supreme Court (“Court”) recently held that the False Claims Act’s (“FCA”) scienter requirement refers to a defendant’s knowledge and subjective beliefs, rather than what a...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

BakerHostetler

Second Circuit Vacates Insider Trading Convictions, Narrowing the Scope of Future Prosecutions

BakerHostetler on

As discussed more fully in our alert when Blaszczak I was issued, the crux of this case was that four individuals were charged with and convicted of an alleged scheme to obtain nonpublic information from the Centers for...more

Bass, Berry & Sims PLC

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

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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

Perkins Coie

US Supreme Court Remands Blaszczak Insider Trading Case Back to the Second Circuit

Perkins Coie on

The U.S. Supreme Court recently cast doubt on the criminal convictions of the one-time “King of Political Intelligence” David Blaszczak and three others for their role in an insider trading scheme. The Court’s action could...more

K&L Gates LLP

K&L Gates Triage: The Impact of Allina — Potential Limitation on CMS’s Ability to Recoup Overpayments

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In this week’s episode, Adam Cooper discusses the Supreme Court’s decision in Azar v. Allina Health Services, as well as a related memorandum issued in late 2019 by the Centers for Medicare and Medicaid Services (“CMS”) that...more

Morgan Lewis - Health Law Scan

HHS Analyzes Legal Impact of Allina on Agency Enforcement

The US Department of Health and Human Services (HHS) Office of General Counsel (OGC) offered the healthcare industry the benefit of its legal analysis of the recent US Supreme Court opinion in Azar v. Allina Health Services...more

Polsinelli

CMS Outlines New Standard for Challenging Medicare Payment Denials, Echoing Brand Memo on Force of Sub-Regulatory Guidance

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On October 31, 2019, the Office of General Counsel for the U.S. Department of Health and Human Services (HHS) issued an important memo from Kelly M. Cleary, CMS Chief Legal Officer, and Brenna E. Jenny, Deputy General...more

Baker Donelson

D.C. Court Rejects CMS's 2018 "Budget Neutrality" Policy

Baker Donelson on

In a September 17, 2019 decision, the United States District Court for the District of Columbia invalidated a CMS rule expanding site-neutral payment reductions to evaluation and management (E&M) services furnished in...more

ArentFox Schiff

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

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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

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