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COVID-19
LDT Oversight May Fall to Congress, CLIA
CEO SUMMARY: After a federal court struck down the FDA’s final rule on laboratory developed tests, attention has shifted to Congress and CLIA as likely paths forward for oversight. A lack of bipartisan momentum makes new legislation unlikely in the near term. Experts sug…
How Labs, Pathologists Should Prepare for Payer Audits
PAYER AUDITS ARE ON THE RISE, AND CLINICAL LABORATORIES AND PATHOLOGY PRACTICES THAT ARE NOT ADEQUATELY PREPARED could face millions of dollars in unexpected recoupment demands. That’s the word from Jane Pine Wood, JD, a healthcare attorney with McDonald Hop…
COLA Summit to Address Lab Staffing Shortages
CEO SUMMARY: An upcoming gathering of COLA’s Workforce Action Alliance will focus on three staffing challenges: improving data needed to understand the current clinical laboratory workforce; promoting career paths for new professionals in the field; and identifying ways …
Quest Acquires ‘Select Assets’ of Fresenius Medical Care
FRESENIUS MEDICAL CARE AND QUEST DIAGNOSTICS AGREED TO A DEAL in which Quest will provide laboratory testing services for the latter’s dialysis clinics in the United States. Separately, Quest Diagnostics will acquire “select assets” of Spectra Labora…
OIG Issues New Report on Medicare 2023 Lab Spend
CEO SUMMARY: When the Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) issued its latest report on Medicare spending in 2023 for clinical laboratory tests, it attracted relatively little attention from the lab industry. Maybe other issues—such a…
January 27, 2025, Intelligence: Late-Breaking Lab News
On Jan. 16, 2025, Paul Mango died at the age of 65. With his passing, the profession of laboratory medicine lost an ally and a friend. In the mid-1990s, while at the Institute for Transfusion Medicine in Pittsburgh, Mango convinced the CEOs of 40 hospitals to collaborate and create t…
Global IVD Companies Issue Third Quarter 2024 Earnings
HERE IS A SUMMARY OF THE THIRD QUARTER FINANCIAL PERFORMANCE of t…
Insights from Q3 2024 Earnings Calls Point to a More Robust Lab Market
FOR THE THIRD QUARTER OF 2024 (Q3 2024), both of the nation’s largest publicly traded laboratories—Labcorp…
Federal Cases against Labs Result in Convictions
CEO SUMMARY: Over the past 24 months, federal prosecutors have announced a steady parade of criminal convictions, guilty pleas, and settlement agreements involving fraud and clinical laboratory testing. Not only are these cases numerous, but some resolve legal actions initiated by the fed…
Global IVD Companies Report Second Quarter 2024 Earnings
IN THE SECOND QUARTER OF 2024, in vitro diagnostics (IVD) companies reported solid revenues as well as new tests, analyzers, and automation. Most of the IVD companies boosted diagnostic sales in low single digit amounts. During the earnings calls, financial analysts asked company leade…
CURRENT ISSUE
Volume XXXII, No. 7 – May 12, 2025
Economic, Tech changes drive lab concerns, The Dark Report provides insights from the Executive War College speakers about how clinical labs can use business strategies and tactics to handle the new tariffs, future regulations, and artificial intelligence (AI). Also, this issue provides guidance on how labs and pathologists should prepare for payer audits.
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