TAG:
clinical laboratory test
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…
Florida Ob-Gyns Call for UHC to End BeaconLBS
CEO SUMMARY: In Florida, obstetricians and gynecologists are complaining about the burdensome nature of the new lab test management system introduced by UnitedHealthcare. In addition to calling for an end to the program, some ob-gyns plan not to use the system, a process that could lead U…
Cigna Sues HDL, Alleges Unlawful Fee Scheme
CEO SUMMARY: In court papers, Cigna alleged that HDL misrepresented patients’ responsibilities by promising not to collect co-payments, co-insurance, or deductibles. Also, HDL promised not to seek reimbursement from patients for any portion of its bills that the health insurer did not c…
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…
Theranos Pursues Different Business Plan in Arizona
CEO SUMMARY: Since its big public debut in late 2013, Theranos has been the subject of keen interest and much skepticism among pathologists and clinical laboratory professionals. Theranos is expanding its presence in Phoenix, Arizona. However, as it does, it looks more like a conventional…
Doctors at Johns Hopkins Improve Lab Test Utilization
CEO SUMMARY: Efforts to help physicians improve their utilization of clinical lab tests paid big dividends at the Johns Hopkins Bayview Medical Center in Baltimore, Maryland. Working collaboratively, physicians and the clinical lab team identified overused or needless cardiac biomarker te…
Humana Reduces Number of Labs in its Networks
CEO SUMMARY: In Ohio, a lab director said his lab was not informed directly about its exclusion from the Humana lab network. Lab officials got the word from their client physicians. In Texas, another lab director said Humana cut 35 lab contracts, reportedly because the insurer wanted to s…
Aetna Files Suit against NJ Lab, Plans to Sue Two More Labs
FINALLY, A MAJOR HEALTH INSURER IS taking a hard line against clinical laboratories it suspects of committing fraud. Aetna Health, Inc., and Aetna Life Insurance Company, of Hartford, Connecticut, have sued one lab company and included physicians as defendants in tha…
Pathologist Raises Questions about Theranos’ Business Model
Dear Editor: I read your two articles on Theranos in the August 11 issue of THE DARK REPORT, and concur in large part with your thoughtful conclusions. For several years, I have closely followed Theranos and have been quoted in trade publications speaking favorably…
September 22, 2014 “Intelligence: Late Breaking Lab News”
Did you know that the world’s longest automation track in a clinical laboratory has just become operational in India? At 93.5 meters (307 feet), it is longer than a football field, according to a press release issued by Siemens Diagnostics. The automation was installed at the centr…
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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