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clinical laboratory testing
January 5, 2015 Intelligence: Late Breaking News
In Vermont, a multi-year effort to create a statewide single-payer health insurance program has failed. On December 17, Governor Peter Shumlin announced that the state would not go forward with its plans to create a health program called Green Mountain Care. “The bottom line is that… it b…
Top 10 2014 Biggest News Stories
Story no.1 SGR Fix by Congress Spawns PAMA; Lab Industry Wary of Law’s Impact ON APRIL 1, PRESIDENT BARACK OBAMA signed into law the Protecting Access to Medicare Act of 2014 (PAMA). As written, it has the potential to be the most impactful federal legislation on the clinical lab industry s…
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…
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…
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…
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…
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…
Ignoring Lab Industry, Theranos Goes Its Way
CEO SUMMARY: With each passing month, Theranos pulls open the curtain a bit more on its business structure and its market growth plans. Its clinical lab tests are now offered in Walgreens pharmacies in Palo Alto, California, and Phoenix, Arizona. Recent news coverage in Fortune and USATod…
‘Game Changer’ Mass Spectrometry for Microbiology at UNC
CEO SUMMARY: Microbiologists at the University of North Carolina are using MALDI-TOF mass spectrometry to slash the time to answer and significantly cut lab costs. Their goals are to improve patient outcomes and reduce average length of stay. In a one-year study presented last month, UNC …
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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