TAG:
clia
Congress Returns to CLIA Reform with Proposed LDT Framework
CEO SUMMARY: A newly introduced federal bill could signal the next chapter in the long-running debate over how laboratory developed tests (LDTs) should be regulated in the United States. Not only does the Enhancing CLIA…
Labs Looking at Cash-Based Options Face Complexity
Given all the challenges of dealing with payers, many clinical laboratories find themselves tempted by the idea of offering cash-based business lines such as direct-to-consumer (DTC) testing. The patient pays up front and undergoes the test, and the lab banks the…
Artificial Intelligence Briefs
NYC Health CEO Suggests Replacing Radiologists with AI Anatomic pathologists may find concern in the words of Michael H. Katz, MD, the CEO at NYC Health + Hospitals, who indicated the system is prepared to substitute AI for radiologists in ce…
Lab Fraudster Warned of ‘Bad Players’ in Old Interview
The audacity of some criminals can be startling. Using fraudulent reimbursement to buy expensive vehicles and mocking Medicare beneficiaries seem to be routine parts of the dishonesty playbook. Former NFL prospect Keith J. Gray, owner of two cl…
Bringing Lab Testing to Hybrid Care Locations
CEO SUMMARY: Clinical laboratory testing plays an important role in individual urgent care and emergency sites, but when such services are offered under one roof, planning for lab tests, related equipment, and CLIA provisions becomes more complicated. TriCore shares its ex…
December 29, 2025, Intelligence: Late-Breaking Lab News
The US Department of Veterans Affairs (VA) is expanding its use of precision medicine through a new multi-year contract with Baylor Genetics to provide pharmacogenomic (PGx) and germline genetic testing to veterans across the VA’s nationwide healthcare system. The agreement includes P…
CAP Regains VA Lab Accreditation Contract
CEO SUMMARY: In a blow to The Joint Commission, the US Department of Veterans Affairs has awarded a new clinical laboratory accreditation contract to the College of American Pathologists (CAP). The decision highlights the competition between the two accrediting organizatio…
Accreditors Explain Changes to CLIA Supervisor Qualifications
In December 2023, the Centers for Medicare and Medicaid Services (CMS) announced major updates to the Clinical Laboratory Improvement Amendments (CLIA) personnel regulations, which went into effect on December 28, 2024. During a panel discussio…
Could AI Oversight in Labs Fall Under a CLIA Model?
CEO SUMMARY: Clinical AI is advancing faster than regulation, creating risk for medical labs. An expert discusses using CLIA to oversee development and ensure safety, performance, and accountability while complementing FDA oversight. Lab leaders face regulatory uncertainty…
Pathologists Hold Sway in Pre-Analytical Fixes
CEO SUMMARY: Up to 70% of clinical laboratory-related errors happen before testing even begins, according to one pathology expert. It’s easy for lab scientists to point the blame elsewhere for problems in the pre-analytical stage, from mis-ordered tests to mishandled sam…
CURRENT ISSUE
Volume XXXIII, No. 8 – June, 2026
Congress Returns to CLIA Reform with Proposed LDT Framework, and the Newly Filed Enhancing CLIA Act seeks to modernize clinical laboratory regulations. A newly introduced federal bill could signal the next chapter in the long-running debate over how laboratory developed tests (LDTs) should be regulated in the United States.
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