Getting Started with the FDA’s New LDT Rule
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
Know where labs may fall foul of compliance requirements—and discover the actions your lab can take to mitigate the risk of noncompliance
Recent enforcement actions show that clinical laboratories must remain vigilant about compliance relating to these areas
Healthcare attorneys explain three digital pathology models for laboratories to be aware of.
When structuring business arrangements, addressing six key risk areas can help laboratories avoid major compliance issues.
An analysis of recent OCR enforcement actions and settlements identifies the common pitfalls labs should watch out for.
Though UDT-related enforcement actions predominate, an uncommon vendor-related case was in the mix this month.
A recent False Claims Act settlement from Kentucky represents an unusual variation on a common theme.
In an analysis of enforcement actions from the end of 2022 to early spring 2023, cases involving urine drug testing were the most prevalent.
Recent OIG report suggests some labs might have gamed Medicare coverage rules in 2020 by billing for unusually high numbers of such tests.
In our latest roundup, schemes involving cancer genetic testing and kickbacks remain the most common, but there were some surprises.