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Congress Seems Ready to Tackle LDT Regulation

RECENT DEVELOPMENTS SIGNAL THAT THE FIGHT over FDA regulation of laboratory-developed tests (LDTs) is about to intensify. Last month, two Congressional representatives announced a new bill about LDTs that they said was a “discussion draft.” The bill is titled the “Diagnostic Accuracy and Innova…

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Diagnostic Error Rate Of 21% Revealed By Mayo Clinic Study

CEO SUMMARY: Researchers at the Mayo Clinic showed that only 12% of patients referred to Mayo physicians for a second opinion got a confirmation that their original diagnosis was complete and correct. In 21% of the cases, the diagnosis was completely changed. Among patients who got additi…

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More Hospitals Consider Options for Their Labs

CEO SUMMARY: Is it a new sign of the times? After decades of reluctance to sell their lab outreach businesses or enter into inpatient lab management agreements with commercial lab companies, a surprising number of hospitals and health systems are taking that step. Since the first of the y…

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Is CMS Manipulating Data to Increase Medicare Fee Schedule Cuts?

This is an excerpt from a 2,150-word article in the April 3, 2017, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: E…

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April 3, 2017 Intelligence: Late Breaking Lab News

For readers with a continuing interest in Theranos, the latest development at the troubled lab testing company involves an offer by Founder and CEO, Elizabeth Holmes, to its current shareholders. Various news outlets report that, for existing shareholders who agree not to sue Therano…

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Will Medicare Lab Test Fee Cuts Happen in 2018?

CLINICAL LABORATORIES THROUGHOUT THE UNITED STATES ARE BRACING for what Medicare officials say will be fee cuts of $400 million in 2018 alone, followed by additional cuts that will total $5.4 billion over 10 years. Of great concern to community laboratories, small and rural hospitals, and physician …

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CMS Extends Reporting of Payer Prices by 60 Days

CEO SUMMARY: Last Thursday, the federal Centers for Medicare and Medicaid Services said it was extending the deadline for certain labs to report their private payer lab test prices by an additional 60 days, until May 30. Statements by CMS officials indicate that either or both the number …

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Texas Lawmakers Asked to Stop UHC and BeaconLBS

CEO SUMMARY: In a letter to the Texas Legislature, 20 Texas medical societies say UnitedHealthcare’s BeaconLBS program would be detrimental to patient care. The Texas Medical Association and the Texas Society of Pathologists said they were concerned that the program increases the admini…

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LabCorp, Quest, Sonic Do Hospital Lab Deals

CEO SUMMARY: Is the New Year’s spate of deals involving the sales of hospital lab outreach programs and a new joint venture the first tremors of an impending earthquake of similar transactions? In the first 10 weeks of 2017, Laboratory Corporation of America, Quest Diagnostics, and Soni…

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Sale to LabCorp to End Most of PAML’s Lab JVs

CEO SUMMARY: It will take several years to understand how the market for lab testing services will change in Seattle and the Pacific Northwest, once Laboratory Corporation of America becomes the owner of PAML, based in Spokane, Wash. Price and financial terms of the sale were not disclose…

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