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
4/16/2025
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Clinical Laboratories ,
Food and Drug Administration (FDA) ,
Judicial Review ,
Laboratory Developed Tests ,
Loper Bright Enterprises v Raimondo ,
Medical Devices ,
Regulatory Authority ,
Statutory Interpretation
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
The First Circuit has issued its long-anticipated opinion in United States v. Regeneron Pharmaceuticals, Inc., clarifying the standard for establishing False Claims Act (“FCA”) liability based on Anti-Kickback Statute (“AKS”)...more
The Fifth Circuit Court of Appeals has handed down a significant decision in response to a challenge from health care providers to the implementing regulations of the No Surprises Act (“NSA”). The Court upheld the...more
On September 30, 2024, the U.S. District Court for the Middle District of Florida issued an order dismissing a qui tam case under the False Claims Act (“FCA”) and holding the relator provisions of the FCA to be...more
In a victory for Texas health care providers, in Baylor All Saints Medical Center dba Baylor Scott & White All Saints Medical Center‑Fort Worth et al. v. Xavier Becerra, case number 4:24‑cv‑00432, the United States District...more
9/11/2024
/ Administrative Procedure Act ,
Chevron Deference ,
Declaratory Relief ,
Department of Health and Human Services (HHS) ,
Disproportionate Share Adjustments ,
Exclusions ,
Federal Trade Commission (FTC) ,
Final Rules ,
Health Care Providers ,
Hospitals ,
Loper Bright Enterprises v Raimondo ,
Medicaid ,
No Surprises Act (NSA) ,
Permanent Injunctions ,
Provider Reimbursement Review Board ,
Texas
In a recent win for health care providers, the United States Court of Appeals for the Fifth Circuit has affirmed a lower court’s decision to vacate key portions of regulations issued by the U.S. Departments of Treasury,...more
8/16/2024
/ Administrative Procedure Act ,
Appeals ,
Appellate Courts ,
Chevron Deference ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Dispute Resolution ,
Health Care Providers ,
Loper Bright Enterprises v Raimondo ,
No Surprises Act (NSA) ,
Out of Network Provider ,
Payment Systems ,
Regulatory Standards ,
SCOTUS ,
U.S. Treasury ,
Vacated
In a recent audit, the Centers for Medicare & Medicaid Services (“CMS”) uncovered non-compliance by Aetna Health Inc. of Texas (“Aetna”) in calculating key payment information for air ambulance services under the No Surprises...more