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Congress Returns to CLIA Reform with Proposed LDT Framework
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. Not only doe...
Expect RESULTS Act Vote by the End of the Year
Evidence at the 2026 Executive War College suggests a coming push in clinical lab advocacy, focusing on the RESULTS Act to establish a permanent, database-driven reimbursement model. Simultaneously, federal regulators have floated the idea of heightened scrutin...
Positioning the Clinical Lab as a Strategic Powerhouse
The 31st Annual Executive War College in New Orleans showcased speakers who have re-imagined the diagnostic laboratory’s role from back-office utility to a primary driver of system-wide strategy and clinical excellence. A consistent theme came up during dozens of sessions at the confe...
Allina Will Join Sutter and Focus on Digital Growth
Minnesota-based Allina Health’s plans to join Sutter Health in California would create a multi-regional integrated delivery network backed by a $2 billion push into digital and outpatient care. As has been illustrated by past agreements and mergers, clinical laboratories for Allina fa...
Ruling Limits Lab Vulnerability on Medical Necessity
A federal appeals court ruling has established a legal “safe harbor” for clinical laboratories, shifting the burden of proof in False Claims Act cases. By allowing labs to generally rely on physician orders as evidence of medical necessity, the decision provides a new defense agains...
Six Themes Will Define the 2026 Executive War College
The 31st Annual Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management is just eight weeks away. From financial performance to digital pathology and AI, this year’s jam-packed conference will deliver practical solutions for today...
PAMA Cuts Averted Until 2027; Labs Must Plan Next Move
Clinical laboratories have again avoided a potential financial disaster, at least for now, after Congress shifted PAMA cuts to test reimbursement rates until January 2027. However, the victory is temporary absent permanent PAMA reform. To that end, laboratory leaders need to push lawmak...
FDA May Reclassify Oncology Companion Diagnostics to Class II Devices
Regulatory attorneys indicate that the FDA’s move to reclassify oncology companion diagnostics to Class II medical devices could speed approvals and reduce costs for submissions. From a business perspective, the proposal could allow clinical laboratories to expand their testing option...
Top Stories in 2025 Played Out in Courts and on Capitol Hill
For clinical laboratory and pathology leaders, 2025 presented a year of profound transformation. Regulatory rulings, legislative efforts, technological innovation, and market consolidation reshaped the landscape for clinical labs. Here, members...
Labs Enter a Critical PAMA Reform Window
CEO SUMMARY: A reprieve of upcoming PAMA cuts to lab test reimbursement rates is official with an extension through Jan. 30, 2026. This, however, is not a lot of time and pressure is on the clinical laboratory industry to get the RESULTS Act passed to permanently reform PAMA. Lab indust...
Don’t Be at the Mercy of the Tumultuous Healthcare Revolution
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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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