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Final Rules Healthcare Regulatory Reform

Seyfarth Shaw LLP

Parity in Peril? Plan Sponsors Breathe Easier As Trump Administration Hits Pause on Enforcement of Mental Health Parity Final Rule

Seyfarth Shaw LLP on

On May 15, 2025 the Departments of Labor, Health and Human Services, and Treasury (the “Departments”) announced they will temporarily not enforce their new standards published under the mental health parity Final Rule last...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

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 6, Issue 3, April 2025

Welcome to our third issue of 2025 of Decoded - our technology law insights e-newsletter. We hope you enjoy this issue and thank you for reading. SEC may Reverse Proposed Cryptocurrency Custody Rule and Ohio House...more

McDermott+

Game On! 2026 Medicare Fee-for-Service Rulemaking Is About to Tip Off

McDermott+ on

Game On! 2026 Medicare Fee-for-Service Rulemaking Is About to Tip Off - It’s March, which means one thing for sports fans: the madness of the NCAA men’s and women’s basketball tournaments. However, to folks in the...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

Mintz - Health Care Viewpoints

PBM Policy and Legislative Update — Winter 2025

The PBM regulatory landscape is rapidly evolving at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry as they happen. Our team...more

Jones Day

CMS's New TCET Pathway Expedites Medicare Coverage for FDA Breakthrough Devices

Jones Day on

The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional Coverage for Emerging Technologies ("TCET") pathway, a Medicare coverage pathway...more

Akin Gump Strauss Hauer & Feld LLP

FDA Finalizes Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products

On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions...more

McDermott+

SPECIAL EDITION: It’s a Regs & Eggs Buffet—Scrambled, Over Easy, Fried, Soft and Hard-Boiled

McDermott+ on

Hungry for some Regs & Eggs? Well, you are in luck, because this week, the Regs & Eggs buffet is open, with your choice of eggs made any style. Enough regs were released this week to feed an entire family—and the...more

Arnall Golden Gregory LLP

In Through the Out Door: FDA Issues Guidance on Its Importation of Prescription Drugs Final Rule

Channeling Led Zeppelin’s “In Through The Out Door,” in May 2022, the Food and Drug Administration issued a guidance for industry entitled, “Importation of Prescription Drugs Final Rule Questions and Answers (Small Entity...more

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