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PAMA Cuts Averted Until ‘27; Labs Plan Next Move

CEO SUMMARY: 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 …

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Cuts to Rural Labs Boost RESULTS Act Support

CEO SUMMARY: Two related legislative concerns should have the sharp attention of clinical laboratory leaders, particularly those in rural areas. On one end, PAMA cuts are scheduled to hit on Jan. 31 short of another reprieve from Congress. Meanwhile, lawmakers at a recent …

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CAP Regains VA Lab Accreditation Contract

CEO SUMMARY: 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 organizatio…

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Accreditors Explain Changes to CLIA Supervisor Qualifications

In December 2023, the Centers for Medicare and Medicaid Services (CMS) announced major updates to the Clinical Laboratory Improvement Amendments (CLIA) personnel regulations, which went into effect on December 28, 2024. During a panel discussio…

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Could AI Oversight in Labs Fall Under a CLIA Model?

CEO SUMMARY: Clinical AI is advancing faster than regulation, creating risk for medical labs. An expert discusses using CLIA to oversee development and ensure safety, performance, and accountability while complementing FDA oversight. Lab leaders face regulatory uncertainty…

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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 c…

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Lab Stakeholders Discuss PAMA Reform

CEO SUMMARY: Medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Although labs have received PAMA reprieves from Congress over the last few years, laboratory associations argue that Congress needs to vote on long-term reforms rather than …

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Using Sophisticated Schemes, Fraudsters Hit the Next Level

Investigators and fraudsters appear to be upping their game as the government seeks to punish those filing unscrupulous Medicare claims. These aspects were clear in the US Department of Justice’s (DOJ) announcement last month of the largest healthcare fraud takedown reportedly in US history. Cli…

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Lab Industry Fallout from CLIAC Termination

CEO SUMMARY: Some diagnostic lab leaders and anatomic pathology practice owners may not immediately think that the elimination of a federal advisory panel should be on their radar. But the demise of the Clinical Laboratory Improvement Advisory Committee may cost labs by de…

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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…

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