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Clinical Laboratories › Centers for Medicare & Medicaid Services (CMS) › Administrative Procedure Act

Morgan Lewis

Federal Court Blocks FDA’s Final Rule on LDTs: Key Considerations for Clinical Labs

Morgan Lewis on

The US District Court for the Eastern District of Texas issued a pivotal ruling in the consolidated lawsuit American Clinical Laboratory Association v. US Food and Drug Administration (FDA) challenging FDA’s final rule to end...more

Proskauer - Health Care Law Brief

Post‑Chevron Spotlight: Federal Court Nixes FDA Rule Reclassifying Laboratory Services as Medical Devices

Proskauer - Health Care Law Brief on

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

Mintz - Health Care Viewpoints

PAMA Laboratory Reporting In Flux: ACLA Wins HHS Lawsuit and Congress Introduces PAMA Amendment Legislation

Mintz - Health Care Viewpoints on

Important developments related to required price reporting to Medicare for clinical laboratories under the Protecting Access to Medicare Act of 2014 (PAMA) have recently occurred. As a result, the clinical laboratory...more

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