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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

Akin Gump Strauss Hauer & Feld LLP

District Court Vacates FDA LDT Rule; What’s Next for Regulation of Lab Testing?

Akin Gump Strauss Hauer & Feld LLP on

On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets...more

Mintz - Health Care Viewpoints

All-Payor Kickback Statute Included in the Recently Passed Opioid Legislation Applies Broadly to Laboratories

Mintz - Health Care Viewpoints on

The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT for Patients and Communities Act”) – which is intended to combat the spread and pernicious...more

Stinson LLP

New Federal Anti-Kickback Prohibition Applicable to Clinical Laboratories

Stinson LLP on

Notwithstanding its name, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 or the SUPPORT Act appears to regulate behavior that has nothing to do with...more

Farrell Fritz, P.C.

Legislation Affecting Hospitals

Farrell Fritz, P.C. on

As we noted in previous blogs, the New York State Legislature has addressed a number of significant hospital related issues during the 2018 session, including indigent care funding, the third iteration of the Statewide Health...more

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