In the Past, Labs Used Courts to Thwart Feds

By Robert Michel | From the Volume XXXII, No. 6 – April 21, 2025 Issue

CEO SUMMARY: A federal judge’s recent decision to vacate the FDA’s final rule on laboratory developed tests harkens back to a 2008 case where clinical labs stopped a CMS competitive bidding project. In the earlier case, legal risks led the government to back down. The …

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OIG Issues New Report on Medicare 2023 Lab Spend

By Robert Michel | From the Volume XXXII, No. 2 – January 27, 2025 Issue

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…

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Lab Briefs: Dec. 16, 2024

By Robert Michel | From the Volume XXXI, No. 17 – December 16, 2024 Issue

55,000 Members of Class Action Case Involving Labcorp…

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Insights from Q3 2024 Earnings Calls Point to a More Robust Lab Market

By Robert Michel | From the Volume XXXI No. 15 – November 4, 2024 Issue

FOR THE THIRD QUARTER OF 2024 (Q3 2024), both of the nation’s largest publicly traded laboratories—Labcorp…

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Once Again, Congress Acts to Defer Medicare Lab Fee Cuts

By Robert Michel | From the Volume XXXI, No. 14 – October 14, 2024 Issue

LAST MONTH, CONGRESS ONCE AGAIN DEFERRED MEDICARE REIMBURSEMENT CUTS OF UP TO 15% f…

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Identifying Current Lab Trends from Labcorp & Quest Experience

By Robert Michel | From the Volume XXXI, No. 11 – August 12, 2024 Issue

CEO SUMMARY: Many different factors influence the operations of clinical laboratories in the United States today. One good source of competitive business intelligence is for lab administrators to follow the quarterly earnings calls of the nation’s two biggest public lab corporations. Wi…

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Several Times, Feds Tried to ‘Redirect’ Lab Activities

By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue

CEO SUMMARY: Regulation of laboratory developed tests (LDTs) by the Food and Drug Administration (FDA) may turn out to be one of the most impactful federal laws or regulations ever promulgated, so far as it pertains to clinical laboratories.cThe Dark Report provides this historical look b…

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Labcorp, Quest Diagnostics Discuss Q4 & 2023 Earnings

By Robert Michel | From the Volume XXXI, No. 4 – March 18, 2024 Issue

DURING RECENT EARNINGS CALLS WITH FINANCIAL ANALYSTS AND INVESTORS, both Labcorp and Quest Diagnostics discussed their fourth quarter (Q4) and full year 2023 financial results. Each reported some stability in the market for clinical laboratory testing services, reflected in the numbe…

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FDA’s Road to Regulation of Lab Developed Tests

By Robert Michel | From the Volume XXX, No. 14 – October 2, 2023 Issue

CEO SUMMARY: Today’s generation of clinical lab managers and pathologists should understand that the FDA’s efforts to publish a draft rule defining its authority to review laboratory developed tests (LD…

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SALSA Bill Resurfaces, Poised to Reduce Upcoming PAMA Cuts

By Scott Wallask | From the Volume XXX, No. 14 – October 2, 2023 Issue

ANOTHER ROUND OF STIFF PRICE CUTS TO THE MEDICARE PART B CLINICAL LABORATORY FEE SCHEDULE (CLFS) is just months away, with the provisions of the Protecting Access to Medicare Act (PAMA) set to resume on Jan. 1. In…

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