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March 2026

Ruling Limits Lab Vulnerability on Medical Necessity

TDR Insider /

A federal appeals court ruling has established a legal “safe harbor” for clinical laboratories, shifting the burden of proof in False Claims Act cases. By allowing labs to generally rely on physician orders as evidence of medical necessity, the decision provides a new defense against whistleblower litigation. The case in question centered on the necessity […]

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A Whistleblower Risk for Lab Leaders to Navigate

Commentary and Opinion by R. Lewis Dark /

Our lead briefing details a federal appeals court case that could end up being a landmark decision in favor of clinical laboratory billing and coding practices. The gist of the decision is that if a diagnostic laboratory performs a test based on a physician’s order, then it creates a safe harbor for the lab that

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Ruling Limits Lab Onus on Medical Necessity

Laboratory Compliance /

CEO SUMMARY: A federal appeals court ruling has established a legal “safe harbor” for clinical laboratories, shifting the burden of proof in False Claims Act cases. By allowing labs to generally rely on physician orders as evidence of medical necessity, the decision provides a new defense against whistleblower litigation. The case in question centered on

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Providers May Be Ordering Inappropriate Vitamin D Tests

Clinical Laboratory Trends /

Heightened consumer interest has been driving demand for vitamin D testing in recent years. However, clinical laboratories should be aware that some providers could be ordering the wrong test to measure levels of the vitamin, in part due to the way that online ordering forms are organized. That was the gist of a paper presented

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How to Strategically Recruit and Retain Young Pathologists

Anatomic Pathology /

The current pathology landscape is ripe with technological advancements that are  creating a surge in talent demand, and yet due to an aging population and a shifting workforce, the supply of qualified pathologists is shrinking. As The Dark Report has long noted to its members, the pathology workforce is aging out, with retirements and burnout

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Major Players Back Robotic Phlebotomy with $70M

Laboratory Automation /

While total laboratory automation has permanently altered the analytical phase of clinical laboratory work, the front-end collection process has remained a stubbornly manual, labor-intensive bottleneck. However, that may be about to change, based on early signs. Vitestro recently announced an over-subscribed $70 million Series B funding round to accelerate operational scaling and commercial readiness for

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In Earnings Calls, Execs at Quest and Labcorp Push for RESULTS Act

Clinical Laboratory /

Chief executives at Labcorp and Quest Diagnostics made it clear during recent investor calls that they want Congress to pass the RESULTS Act. The Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act is seen by many in the clinical lab industry as perhaps the last chance to reform unpopular diagnostic test provisions

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Pathology Lab Opportunities for Biopharma Collaboration

Laboratory Management /

As anatomic pathology laboratories face declining reimbursements and other challenges to their bottom lines, one possible solution could involve collaboration with biopharmaceutical companies. But what exactly are drug companies looking for, and how can labs forge those relationships? Three biopharma executives addressed these questions during a session at the 2025 Executive War College. “The needs

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March 23, 2026, Intelligence: Late-Breaking Lab News

Late Breaking Lab News /

LinkedIn’s “Skills on the Rise” report shows that shifting workforce demands are reshaping clinical laboratory roles. Released on Feb. 24, the report looked at the 10 fastest-growing skills in the healthcare industry. The data signals that technical expertise alone is no longer sufficient. Workflow optimization ranked as the fastest-growing skill, reflecting pressure to improve efficiency

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Six Themes Will Define the 2026 Executive War College

TDR Insider /

The 31st Annual Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management is just eight weeks away. From financial performance to digital pathology and AI, this year’s jam-packed conference will deliver practical solutions for today’s busy clinical laboratory executives. Despite stepping down last year from day-to-day duties, event founder Robert L. Michel’s influence will

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