Pulse: Who’s Counting the Labs?

This episode looks at new pressure points in lab medicine: payment reporting, LDT oversight, liquid biopsy expansion, supplier stability, and compliance risk.

PAMA reporting: CMS is collecting private-payer data for the Clinical Laboratory Fee Schedule, but Laboratory Economics reports CMS may not know exactly which labs qualify as “applicable laboratories.” That raises questions about data quality, enforcement, and future Medicare lab rates.

Enhancing CLIA Act of 2026: A new bill from Rep. Neal Dunn would keep LDT oversight centered in CLIA/CMS rather than FDA device regulation. It proposes a public LDT database, more transparency around validation and performance, third-party validity confirmation, centralized error reporting, and stronger CMS authority when LDT validity is questioned.

Guardant360 Liquid CDx: Guardant received FDA approval for an expanded liquid biopsy panel. The story highlights the growing role of blood-based genomic profiling in oncology, along with challenges around interpretation, limitations, and reimbursement.

Bio-Rad and Elliott: Elliott reportedly built a stake in Bio-Rad. For labs, this is a reminder that vendor strategy and financial pressure can affect reagents, QC materials, instruments, service, and validated workflows.

Key Takeaway

Labs are being asked to support payment policy, regulatory oversight, precision medicine, supply chains, and compliance systems. The big question: are the people designing these systems accounting for how labs actually work?