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acla
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 …
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…
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…
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…
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…
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 …
With LDT Rule Vacated, Labs Await FDA Retort
CEO SUMMARY: In a major win for clinical laboratories, a federal judge vacated the FDA’s final rule on LDTs, writing in his decision that the agency overstepped its authority. For now, labs can develop and modify LDTs without FDA oversight, but future action in some form…
Why Labs Should Comply with FDA’s Final Rule on LDTs
CEO SUMMARY: Even as lawsuits challenging the Laboratory Developed Test (LDT rule) issued by the federal Food and Drug Administration (FDA) progress in federal court, clinical labs performing LDTs face an interesting decision. Should they invest the staff time and money to comply with the…
Pathologist Asks ChatGPT, Google Notebook to Predict LDT Trial Outcome
On his blog last month, pathologist Bruce Quinn, MD, PhD, published the answers provided by two artificial intelligence chatbots after he asked each to analyze the legal briefs submitted to federal courts in Texas where lab plaintiffs are challenging the FDA’s laboratory developed test (LDT) final …
Using AI to Predict Outcomes in FDA LDT Lawsuits
Given the popular sentiment that artificial intelligence (A…
CURRENT ISSUE
Volume XXXIII, No. 1 – January 19, 2026
The Dark Report looks at the FDA’s move to reclassify Oncology companion diagnostics as Class II medical devices and considers how labs can benefit. Also, observers are concerned about the effect of PAMA cuts on rural clinical laboratories.
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