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Volume XXXII, No. 13 - September 15, 2025

RESULTS Act Directly Attacks Upcoming PAMA Cuts

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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RESULTS Act Offers Another Chance at PAMA Relief

OVER YOUR SHOULDER, YOU MAY HEAR THE CLOCK TICKING when it comes to laboratory test reimbursement rate cuts coming under the Protecting Access to Medicare Act of 2014 (PAMA). Short of action by Congress, on Jan. 1, 2026, more than 800 tests will get hit with up to a 15% reduction in rates. It’s a

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Labs Directly Attack Upcoming PAMA Cuts

CEO SUMMARY: 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. The new RESULTS Act offers

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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 samples. But lab leaders can take ownership of pre-analytical quality using a series of practical

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Court: Percentage-Based Comp Is Not Illegal in Itself

OUR MEMBERS LEARNED IN THE PRIOR ISSUE ABOUT AN IMPORTANT COURT RULING that interpreted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA), a law that has long been maligned by clinical laboratories for its murkiness. The Dark Report has since talked in detail to healthcare attorney Karen Lovitch with the law firm Mintz about

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2025 Ranking of the World’s Top 13 IVD Corporations

BASED ON PUBLICLY-REPORTED 2024 DIAGNOSTICS-RELATED REVENUE, four in vitro diagnostics (IVD) companies continue to dominate the global market, as they have for the last two years: Thermo Fisher Scientific, Roche, Danaher, and Abbott Laboratories. The top 13 companies reported $91.9 billion in diagnostic-related revenue in 2024 compared to $88.7 billion the year before. Danaher and

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Deal Offers Signals about the Future of Digital Pathology

THE DIGITAL PATHOLOGY MARKET IS AT AN INFLECTION POINT, AND TEMPUS’ RECENT $81.25 MILLION ACQUISITION OF PAIGE underscores both the challenges and opportunities ahead. While the pandemic temporarily accelerated digital pathology adoption, with vendors raising large sums on the promise of artificial intelligence (AI)-powered diagnostics and remote workflows, the realities of cost, reimbursement hurdles, workflow

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Quest, Labcorp Discuss PAMA and M&A with Investors

WHILE LAUDING EXCELLENT GROWTH FOR THE SECOND QUARTER, executives at Labcorp and Quest Diagnostics also expressed concern over the Protecting Access to Medicare Act (PAMA), which was passed by Congress in 2014 and which continues to cause uncertainty as full implementation is repeatedly delayed. PAMA requires Medicare to base its Clinical Laboratory Fee Schedule (CLFS)

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September 15, 2025, Intelligence: Late-Breaking Lab News

Owners of pathology practices and clinical labs will want to be aware of recent action by the Federal Trade Commission (FTC) regarding non-compete clauses. The FTC sent letters to several large healthcare employers asking them to review their non-compete agreements. “Many healthcare employers … include unreasonable noncompete agreements in employment contracts for vital roles like

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