
New Enhancing CLIA Act: What Lab Directors Need to Know
The proposal seeks to move any future LDT authority away from the FDA

The proposal seeks to move any future LDT authority away from the FDA

Consultant Nora Hess offers suggestions for clinical labs to navigate these problems

Other proposals aim to increase fraud enforcement, temper prior authorization, and modernize CLIA

FDA-CMS collaboration aims to accelerate Medicare coverage determinations of certain medical devices

Validating applicable laboratory status is an important first step in reporting