TAG:
lab administrator
New Federal Law Changes How CMS Sets Lab Prices
CEO SUMMARY: CMS wanted more power to cut the prices it pays for clinical lab testing. A significant part of the lab industry wanted more transparency and consistency in how CMS established coverage guidelines and prices for new lab tests. Congress appears to have attempted to craft a law…
CMS Gives Deemed Status to A2LA under CLIA Law
CEO SUMMARY: Quietly published in the March 25 issue of the Federal Register was a notice that CMS had granted deeming authority for CLIA to the American Association for Laboratory Accreditation (A2LA). This action gives laboratories in the United States a new choice to meet the accredita…
Whole Genome Sequencing Is Poised for Clinical Use
CEO SUMMARY: Pathologists and clinical lab managers interested in following the advances in use of whole human genome sequencing for clinical purposes should follow the money. Within weeks of obtaining FDA clearance for its MiSeqDx system and reagents, Illumina had inked major agreements …
Clinical Labs Spending Money in New Ways
CEO SUMMARY: In response to the many changes now unfolding in the U.S. healthcare system, labs are investing their scarce capital in different ways. Five trends in lab spending can be identified. They range from expanding the informatics capabilities of a lab organization to acquiring the…
Labs, Path Groups Face Major Financial Issues
CEO SUMMARY: Are clinical labs and pathology groups ready for the end of fee-for-service reimbursement? That’s just one important question that will be answered at the upcoming Executive War College on Lab and Pathology Management that will take place in New Orleans on April 29-30. The …
Sonora Quest Builds EMPI To Serve Patients and ACOs
CEO SUMMARY: Probably no state has seen a faster transition to ACOs, medical homes, and other types of integrated clinical care organizations than Arizona. Recognizing that this change created a new opportunity to add more value with clinical lab testing services, Sonora Quest Laboratorie…
Medicare Price Cuts Drive Labs to Sell or File BK
CEO SUMMARY: Professional investors are smart with their money. Thus, it is no surprise that clinical lab and pathology companies owned by private equity firms are the first to be sold or closed. These investors are acting in response to the cumulative negative financial impact of recent …
Broward Health’s Lab Pursues Multiple Ways to Cut Lab Costs
CEO SUMMARY: Tasked with cutting $2 million from their lab’s annual operating budget, the lab team at Broward Health System instituted changes that included a lab test formulary and ordering algorithms. In collaboration with physicians, these changes reduced the use of outmoded tests wh…
Portland Lab Leverages Informatics for Growth
CEO SUMMARY: In Portland, Oregon, Legacy Laboratory Services, a division of Legacy Health, continues to post strong volume growth. One driver supporting this growth is the lab’s ability to implement connections between its laboratory information system (LIS) and the electronic …
Theranos Won’t Discuss Disruptive Lab Technology
CEO SUMMARY: In a partnership with Walgreens pharmacies, Theranos Inc. announced that it will run clinical lab tests on “micro-samples” and collect these blood samples without venipuncture. Even as Theranos touts the patient-friendly benefits of its proprietary diagnostic technology, …
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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