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PAMA

Clinical Labs Must Prep for Heightened Audits

CEO SUMMARY: A new report from the Office of Inspector General sheds interesting light on just how much genetic testing has increased among Medicare Part B beneficiaries. With billions of dollars in reimbursement at stake for clinical laboratories, expect federal officials…

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Office of Inspector General Briefs

Congress Wants Review of Test Fraud As part of a spending bill approved by Congress recently, there is a small provision that hints at future review of clinical laboratory tests by the US Department of Health and Human Services’ Office of Inspector General (OIG)….

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Permanent PAMA Reform Must Happen in 2026

Previously, it would have been hard to imagine …

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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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Patient-Driven Testing Spurs New Opportunities

CEO SUMMARY: Patient-driven diagnostic testing is creating both opportunities and challenges for clinical laboratories, as increased demand and evolving business models stretch the industry’s capacity and profitability. However, an industry veteran in commercial lab prod…

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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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Top Stories in 2025 Played Out in Courts, Capitol Hill

CEO SUMMARY: The biggest story of the year for clinical laboratories came in a huge court victory, as a federal judge vacated the FDA’s final rule on laboratory developed tests. Labs breathed a sigh of relief after the court decision, as the FDA rule had promised to incr…

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Labs Enter a Critical PAMA Reform Window

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 PA…

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Congress is Listening. Labs Must Step Up on PAMA

Just as The Dark Report went to press for this issue, the US federal government reopened after the longest shutdown in the country’s history. And while political pundits on both sides of the spectrum argued about who won and lost during the shutdown, it was clear that the cli…

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After SALSA Hits a Wall, New RESULTS Act Steps In

Upon reading the briefing in the last issue about the Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act, someof our members may have wondered,“What happened to SALSA?” SALSA, more formally known as the…

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