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Enforcement › Medical Devices › Centers for Medicare & Medicaid Services (CMS)

Husch Blackwell LLP

DOJ and HHS Launch New False Claims Act Working Group: What The Healthcare Industry Needs to Know

Husch Blackwell LLP on

On July 2, 2025, the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced the creation of the DOJ-HHS False Claims Act Working Group, a high-level interagency initiative aimed at...more

Gardner Law

Sunshine Act Compliance: How to Take Action to Meet Reporting Requirements and Avoid Costly Penalties

Gardner Law on

The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

Venable LLP

Summary of LDT Rule: An In-depth Look at the Final Rule Regarding Laboratory-Developed Tests

Venable LLP on

The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...more

Mintz - Health Care Viewpoints

CMS Publishes Final Sunshine Act Rule; Data Collection to Begin on August 1, 2013

Mintz - Health Care Viewpoints on

The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register. It amends key definitions and adds new terms; retains broad reporting...more

Holland & Knight LLP

CMS Issues Final Physician Payment Sunshine Rule

Holland & Knight LLP on

In an action that will have broad implications for drug and device manufacturers, researchers, distributors, teaching hospitals and physicians, on February 1, the Centers for Medicare and Medicaid Services (CMS) publicly...more

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