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Regulatory Requirements › Risk Management › Clinical Laboratory Testing

Hendershot Cowart P.C.

EKRA Gets Its Second Major Court Test: What the Schena Decision Means for Lab Marketing and Sales Compensation

Hendershot Cowart P.C. on

On July, 11, 2025, the Ninth Circuit Court of Appeals affirmed laboratory operator Mark Schena’s conviction under Eliminating Kickbacks in Recovery Act (EKRA). This is the first time a higher court has addressed the lab...more

Mintz - Health Care Viewpoints

FDA’s Backup LDT Enforcement Method: Specimen Collection Kits

Mintz - Health Care Viewpoints on

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

Robinson & Cole LLP

COVID-19 Testing — Additional Considerations

Robinson & Cole LLP on

At the start of the COVID-19 pandemic, each state and the federal government announced various states of public health emergencies which enabled them to suspend or modify various laws, rules, and regulations to accommodate...more

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