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Six Themes Will Define the 2026 Executive War College

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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’s busy clinical laboratory executives. Despite stepping down last year from day-to-day duties, event founder Robert L. Michel’s influence will […]

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PAMA Cuts Averted Until 2027; Labs Must Plan Next Move

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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 lawmakers to pass the RESULTS Act, with one healthcare attorney suggesting that labs

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FDA May Reclassify Oncology Companion Diagnostics to Class II Devices

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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 options, bring more tests in house, and attract new investment. The public comment period for the

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Top Stories in 2025 Played Out in Courts and on Capitol Hill

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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 of The Dark Report can read our top 10 stories of the year. In a repeat from last year, regulation of laboratory developed tests (LDTs)

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Labs Enter a Critical PAMA Reform Window

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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 industry advocates are urging individual diagnostic

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NYU Langone Rolls Out Digital Pathology in One Year

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During an ambitious one-year project, NYU Langone Health implemented full-scale digital pathology. Although the initiative was large, a key organizer insists that smaller diagnostic labs can use some of the same approaches. Two big lessons to convey: Document the gritty details of pathology workflows with the IT team and push technology vendors to help a

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CAP Regains Veterans’ Affairs Lab Accreditation Contract

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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 organizations and sheds light on how CAP’s inspection process holds value to the federal agency. The deal could

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After Regaining its Outreach Service, Lab Grows It by $10M

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In this case study, Kootenai Health in Idaho explains how taking back lab outreach services from a commercial lab company can improve physician satisfaction, enhance patient care, and increase revenue. Although the transition was bumpy, within two years of bringing outreach in house, those services contributed $10 million to the health system’s bottom line. This

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RESULTS Act Directly Attacks Upcoming PAMA Cuts

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The clinical laboratory industry once again finds itself advocating on Capitol Hill for proposed legislation to deal with an old problem: test reimbursement rate cuts under PAMA. While Congress has delayed scheduled rate cuts for the last several years, PAMA critics feel a more permanent solution is needed. A new act offers hope that action

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What’s Behind the Surge in Laboratory Outreach Sales?

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The recent CHS-Labcorp deal is one of many that highlights a market shift. Clinical lab outreach services, once viewed as strategic assets, are being sold off rapidly as hospitals recenter around core services and offload logistical burdens. This year, 30% of lab mergers and acquisitions involve outreach agreements, with national lab companies seeing opportunities to

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