TAG:
lab risk & compliance
Owens & Minor Sues Anthem BCBS of Virginia
CEO SUMMARY: For years, clinical laboratories and pathology groups have expressed frustration with the lack of transparency by health plans in how they handle claims, set prices, and establish coverage guidelines. Now, because of recent federal laws and rules concerning health data transp…
Two Different LDT Lawsuits Combined in Federal Court
CEO SUMMARY: Different lawsuits challenging the FDA’s LDT rule were filed in recent months by the American Clinical Laboratory Association and the Association for Molecular Pathology. Both lawsuits were filed in the U.S. District Court for the Southern …
Internet Tracking Lawsuits Target Quest and Labcorp
CEO SUMMARY: Here is the clinical lab industry’s first intelligence briefing on how class action attorneys are filing lawsuits against healthcare providers—including clinical laboratories. The allegations are that providers are using internet tracking tools, such as those offered by M…
Federal Cases against Labs Result in Convictions
CEO SUMMARY: Over the past 24 months, federal prosecutors have announced a steady parade of criminal convictions, guilty pleas, and settlement agreements involving fraud and clinical laboratory testing. Not only are these cases numerous, but some resolve legal actions initiated by the fed…
Hospital Lab Outreach: Still a Valuable Asset!
CEO SUMMARY: Hospital lab administrators everywhere are watching press releases announcing the latest agreement of a major health system selling its laboratory outreach business to one of the billion-dollar lab corporations. The pace of these sales is accelerating. These deals confirm the…
Federal Court Issues Ban on FTC’s Noncompete Rule
BY NOW, MOST CLINICAL LAB MANAGERS AND PATHOLOGY PRACTICE ADMINISTROATORS ARE AWARE of the Federal T…
HHS Issues Final Rule to Deal with Information Blocking
ANY HEALTHCARE PROVIDER DETERMINED TO HAVE COMMITTED “INFORMATION BLOCKING” can now be asse…
Language in Draft House Bill Directs FDA to Suspend LDT Rule
THERE IS AN INTERESTING NEW DEVELOPMENT associated with the regulation of laboratory deve…
Behind-the-Scenes Audits Often Hide Cause of Test Claim Denials
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Several Times, Feds Tried to ‘Redirect’ Lab Activities
CEO SUMMARY: Regulation of laboratory developed tests (LDTs) by the Food and Drug Administration (FDA) may turn out to be one of the most impactful federal laws or regulations ever promulgated, so far as it pertains to clinical laboratories.cThe Dark Report provides this historical look b…
CURRENT ISSUE
Volume XXXII, No. 10 – July 14, 2025
This issue is strong on different flavors of enforcement that clinical laboratories, whether they want to or not, will need to contend with. Lab stakeholders provide insights that medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Also, this issue provides the legal and regulatory landscape for clinical labs’ use of AI and how it evolves with the technology. AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics.
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