TAG:
laboratories
Medicare Special Stain LCD May Hinder Pathology Workflow
CEO SUMMARY: Under a proposed rule for Medicare region J-11, a pathologist will no longer be able to use “reflex templates or pre-orders for special stains and/or IHC stains prior to review of the routine H&E.” While the proposed LCD is designed to target a relatively small number…
Level Two of Value Pyramid Defines Internal Benchmarks
CEO SUMMARY: In this second installment of our series on the laboratory value pyramid, we introduce “Level Two: Establish and Meet Standards of Value.” This second level continues the lab’s focus on its internal operations and activities. The goal is for the lab to develop the working cultu…
Attorneys Outline Issues in FDA’s LDT Guidance
CEO SUMMARY: Officials at the FDA believe that CLIA does not go far enough because it does not address the issues of whether laboratory-developed tests (LDTs) have been designed correctly or have been manufactured in accordance with sound standards. Also, CLIA does not include a process to verify…
November 24, 2014 Intelligence: Late Breaking Lab News
Interesting things are unfolding in San Diego with Pathway Genomics, a company with a CLIA lab that offers genetic testing to physicians. On November 12, it was announced that the IBM Watson Group had invested in Pathway Genomics. The two companies said that they are…
Where Are Pathologists When You Need Them?
WHAT’S WRONG WITH THIS PICTURE? National health insurer has exclusive national contract with a single billion-dollar lab company. Billion-dollar lab company creates a business division to manage how physicians order lab tests. This lab test order system requires physicians to follow the lab test o…
Public Comment Started on FDA LDT Regulations
CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucrat…
LabCorp, Quest Diagnostics Report Improved Q-3 Revenue
THIRD QUARTER EARNINGS at each of the nation’s two biggest public lab companies showed improved growth in revenue and specimen volume, as compared to recent years. Laboratory Corporation of America was first to release its financial report for the quarter ending September 30, 2014…
November 03, 2014 Intelligence: Late-Breaking Lab News
In response to the Ebola outbreak, the Food and Drug Administration issued an emergency authorization for the use of two rapid tests to detect Ebola. The tests are manufactured by BioFire Defense LLC, a division of BioMerieux. The BioFire Defense Fil…
Physicians and Labs Wary of United’s Lab Test Program
CEO SUMMARY: Providers seem to have a natural distrust of health insurers, particularly when payers introduce new programs with the stated purpose of improving quality and ensuring that physicians deliver evidence-based medicine. Doctors serving members of UHC’s HMO plans in Florida are…
FL Docs Say: ‘No Thanks’ to UHC and BeaconLBS
CEO SUMMARY: Some Florida physicians are declaring their intent to leave UnitedHealthcare’s network because they find the insurer’s new BeaconLBS laboratory benefit management system to be time consuming and onerous. The defections come as the program goes through a soft launch that b…
CURRENT ISSUE
Volume XXXII, No. 14 – October 6, 2025
The Dark Report examines increasing healthcare costs for employers and how clinical labs can help those employers. Also, an in-depth case study shows how one hospital system regained its outreach program after originally ceding it to a national lab company, adding millions to the system’s bottom line.
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