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
FDA-CMS collaboration aims to accelerate Medicare coverage determinations of certain medical devices
Expert Ashley Zarling details nuances for clinical lab directors and compliance teams
Cuts to reimbursement rates under PAMA have been pushed back again by Congress, this time to January 2027
CMS tweaked its CE, documentation, and on-site visit requirements for directors
Third-party verification of lab personnel experience is now a CLIA requirement
However, a proposed bill called the RESULTS Act is racing to thwart the cuts to lab test reimbursement rates
Clinical labs gain flexibility in meeting regulatory standards while potentially reducing their costs
Washington State’s Department of Health details how its medical testing site program meets federal standards
Read this overview of legislation and regulations governing laboratory marketing practices and learn tips to ensure these activities remain compliant
As of March 1, 2026, CMS will move CLIA away from paper-based transactions to improve efficiency and payments