Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics
Ā VICTORY IN COURT! FOR AN INDUSTRY THAT OFTEN FINDS ITSELF on the wrong end of legal deliberations (see Theranos or various Department of Justice cases), it feels good to have a judge side with clinical laboratories. We are, of course, talking about the recent ruling from Judge Sean Jordan in Texas in which he […]
Enjoy the LDT Court Victory, Yet Remain Vigilant Read More Ā»
CEO SUMMARY: In a major win for clinical laboratories, a federal judge vacated the FDAās 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 is likely. In part one of our report about
With LDT Rule Vacated, Labs Await FDA Retort Read More Ā»
In a major win for clinical laboratories, a federal judge vacated the FDAās 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 is likely. In part one of our report about the decision,
With LDT Rule Vacated, Labs Await FDA Response Read More Ā»
CEO SUMMARY: A federal judgeās recent decision to vacate the FDAās final rule on laboratory developed tests harkens back to a 2008 case where clinical labs stopped a CMS competitive bidding project. In the earlier case, legal risks led the government to back down. The FDA could choose not to appeal the LDT ruling to
In the Past, Labs Used Courts to Thwart Feds Read More Ā»
LESS THAN TWO MONTHS AFTER ANNOUNCING PLANS to sell off or otherwise divest of its in vitro diagnostics (IVD) and life sciences divisions, Becton Dickinson (BD) appears to be in talks already with several competitors about the would-be deal. Citing anonymous sources, the Financial Times reported on April 1 that BD had already engaged in
BD Will Sell Diagnostics Arm but Retain Vacutainer Brand Read More Ā»
CEO SUMMARY: Five years ago, it seemed a solid prediction that retail pharmacies would establish a stronghold in primary care and offer wider access to common diagnostic testing services that clinical laboratories provide. Fast forward to 2025, and the market does not look as rosy for primary care at pharmacies. Still, alert lab leaders may
Testing at Pharmacies Enters a Murky Future Read More Ā»
DEMONSTRATING THAT EVEN ROUTINE TESTS CAN CAUSE LEGAL HEADACHES for clinical laboratories, the U.S. Department of Justice announced in January that it had reached a $704,349 agreement with OPKO Health Inc. and BioReference Health LLC (BRH) to settle allegations that BRH billed Medicare and other federal healthcare programs for medically unnecessary blood tests. The settlement
OPKO Settles Allegations of Fraudulent Billing Read More Ā»
LITTLE DETAILS CAN MAKE A BIG DIFFERENCE in not only how customers view a clinical laboratory, but also in ensuring incorrect information about diagnostics services does not spread in a community. That was a core theme at the Lab Manager Leadership Summit, which took place April 7-9 in Pittsburgh and was hosted by Lab Manager,
Clinical Lab Test Jargon Could Spur Mistrust among Patients Read More Ā»
The administration of President Donald Trump is calling for a $40 billion cut in funding to the U.S. Department of Health and Human Services (HHS), according to a report in The Washington Post on April 16. This amount would come from HHS discretionary spending, which Congress must approve. It is not clear yet how lawmakers
April 21, 2025, Intelligence: Late-Breaking Lab News Read More Ā»
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