News & Analysis as of

Final Rules Enforcement Actions Healthcare

McDermott Will & Emery

Enforcement of Mental Health Parity Regulations Suspended: Takeaways for Plan Sponsors and Health Insurance Issuers

McDermott Will & Emery on

In January 2025, The ERISA Industry Committee (ERIC) filed a complaint against the US Departments of Labor, Health and Human Services, and the Treasury (the departments) seeking to invalidate the 2024 final regulations under...more

Quarles & Brady LLP

Departments Will Not Enforce 2024 Final Rule under MHPAEA

Quarles & Brady LLP on

The Trump Administration has just announced that it will pause enforcement of the September 2024 final rule (“Final Rule”) under the Mental Health Parity and Addiction Equity Act (“MHPAEA”)....more

Epstein Becker & Green

Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®

On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory-developed tests (LDTs). The court’s judgment...more

Goodwin

2024 Year in Review: Cards, Payments, and Consumer Banking

Goodwin on

We expect continued scrutiny by regulators on fees, including enforcement actions and rulemakings, with the caveat that the new administration could shift federal priorities away from this fee crackdown....more

Mintz - Health Care Viewpoints

FDA’s Backup LDT Enforcement Method: Specimen Collection Kits

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase...more

Skadden, Arps, Slate, Meagher & Flom LLP

Closing the GRAS Loophole: Secretary Kennedy’s Plan To Enhance FDA Food Safety Regulations

On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized...more

Brownstein Hyatt Farber Schreck

Breaking Down a New Day at the CFPB

After weeks of emptying the shelves at the Consumer Financial Protection Bureau (CFPB) with dozens of enforcement actions, new rules, proposed regulations and guidance, President Donald Trump fired CFPB Director Rohit Chopra...more

Davis Wright Tremaine LLP

Stay ADvised: 2025, Issue 3

FTC's Final Junk Fees Rule Narrowed in Scope - On December 17, 2024, the Federal Trade Commission (FTC) released its final Rule on Unfair or Deceptive Fees, commonly known as the "Junk Fees Rule." This final rule has a...more

Ropes & Gray LLP

FDA Finalizes Guidance on Communication of Scientific Information on Unapproved Uses and Releases Updated First Amendment Analysis

Ropes & Gray LLP on

On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more

Morgan Lewis - As Prescribed

Balancing Safety and Accessibility: FDA Broadens Approval Pathway for Nonprescription Drugs by Finalizing the ‘ACNU’ Rule

The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug products by allowing the approval of a nonprescription drug product with an “Additional Condition...more

Sheppard Mullin Richter & Hampton LLP

Secret Rules and Hidden Penalties: Biden Executive Order Takes Aim at the Trump Administration’s Efforts to Limit HHS’s Use of...

Executive Orders and the Biden Administration’s promises to postpone or withdraw certain last-minute, so-called “midnight rules” promulgated by the Trump Administration are currently grabbing everyone’s attention, especially...more

Mintz - Health Care Viewpoints

Skeletons in the Closet? Beware of Potential Enforcement Actions

With Halloween looming, a discussion of skeletons that may be lurking in a health care provider’s closet is timely. Many of our previous posts, as well as the monthly Qui Tam Updates published by our Health Care Enforcement...more

Fisher Phillips

USDOL "Companionship", "Live-In Domestic" Enforcement Coming

Fisher Phillips on

The U.S. Labor Department has now announced that, beginning on November 12, it will start enforcing its revised regulations governing the Fair Labor Standard Act's Section 13(a)(15) "companionship" exemption and Section...more

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