Does the First Amendment protect associations’ communications with their members when petitioning government agencies?...more
5/9/2025
/ Business Entities ,
California ,
Constitutional Challenges ,
Federal Trade Commission (FTC) ,
First Amendment ,
Fraud ,
Government Agencies ,
Judicial Authority ,
Misrepresentation ,
Rulemaking Process ,
Trade Associations
Key Insights for Pharma Manufacturers Regarding the AKS -
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more
4/29/2025
/ Abbreviated New Drug Application (ANDA) ,
Anti-Kickback Statute ,
Compliance ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements
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
The landscape is in flux right now for nonprofits, to say the least. To help structure your action plan, these are some of the top questions our Nonprofits & Associations team has been helping our clients think through....more
3/11/2025
/ Antitrust Provisions ,
Antitrust Violations ,
Compliance ,
Copyright ,
Data Privacy ,
Diversity and Inclusion Standards (D&I) ,
Employment Discrimination ,
Executive Orders ,
Federal Funding ,
Intellectual Property Protection ,
Nonprofits ,
Risk Management ,
Trademarks
On August 2, health care providers scored yet another significant victory when the US Court of Appeals for the Fifth Circuit affirmed the vacatur of various federal regulations regarding the arbitration procedures used to...more
8/8/2024
/ Arbitration ,
Arbitrators ,
Certiorari ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Dispute Resolution ,
Final Rules ,
Health Care Providers ,
Insurance Industry ,
No Surprises Act (NSA) ,
Reimbursements ,
SCOTUS ,
U.S. Treasury
On December 18, 2023, the US Departments of Treasury, Labor, and Health and Human Services (the Departments) issued a rule finalizing the 2024 non-refundable administrative fee parties must pay to access the arbitration...more
*This is the 12th article in a series analyzing the No Surprises Act and its implementation. To view the entire series, click here. A link to the proposed rule is here. As background, Congress passed the Act to prevent...more
On October 3, the US Food and Drug Administration (FDA) issued a proposed rule regarding the regulation of in vitro diagnostic products (IVDs). In this proposed rule, the FDA announced its intent to amend its regulations to...more
10/25/2023
/ Affordable Care Act ,
CLIA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Medical Devices ,
Medicare ,
Premarket Approval Applications ,
Proposed Legislation ,
Proposed Rules ,
Regulatory Oversight
On September 21, 2023, the US Departments of Treasury (DOT), Labor (DOL), and Health and Human Services (HHS) (the Departments) issued new rulemaking governing the administrative fee required to access the arbitration process...more
10/4/2023
/ Arbitration ,
Biden Administration ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Fees ,
Final Rules ,
No Surprises Act (NSA) ,
Proposed Regulation ,
Rulemaking Process ,
Surprise Medical Bills ,
U.S. Treasury
On August 24, 2023, health care providers in Texas scored yet another victory when a federal court vacated additional portions of the Biden Administration’s rulemaking under the federal No Surprises Act (the Act). This marked...more
Last week, the US Court of Appeals for the Ninth Circuit, in its third opinion in the case, reversed a lower court’s decision allowing patients challenging United Behavioral Health’s (UBH) internal mental health coverage...more
On August 3, 2023, health care providers in Texas scored yet another victory when a federal court vacated additional portions of the Biden Administration’s rules governing fee collection and claim batching under the federal...more
8/22/2023
/ Administrative Procedure Act ,
Arbitration ,
Biden Administration ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Dispute Resolution ,
Fees ,
Health Care Providers ,
Rulemaking Process ,
Surprise Medical Bills ,
U.S. Treasury
With the new year underway, the ArentFox Schiff Health Care team highlights 10 of the most pressing legal issues facing the industry in 2023.
End of the COVID-19 Public Health Emergency. After being in effect for more than...more
2/17/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Dobbs v. Jackson Women’s Health Organization ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Healthcare ,
HIPAA Privacy Rule ,
Inflation Reduction Act (IRA) ,
No Surprises Act (NSA) ,
Popular ,
Proposed Rules ,
Public Health Emergency ,
Reproductive Healthcare Issues ,
Roe v Wade ,
SCOTUS ,
Telehealth