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laboratory service
January 9, 2017 Intelligence: Late Breaking Lab News
December 27 was the 100th birthday of pathologist Jan Steiner, MD, FRCP (C), FCAP, remembered by many long-serving lab executives and clinical pathologists as one of the co-founders, along with James Root, PhD, of Chi Laboratory Systems in the late 1980s. This was a time when he was…
NJ Lab Sues to Challenge Payers About Its Out-of-Network Status
ONE WAY THAT A CLINICAL LAB can fight back against insurers who refuse to pay lab test claims is to sue them. That’s exactly what Medical Diagnostic Laboratories of Hamilton, N.J. is doing! Not only has MDL filed lawsuits against two major health insurance companies, but in one la…
Will Coming Medicare Fee Cuts Reduce Access to Laboratory Tests?
SEVERAL IMPORTANT clinical laboratory associations are concerned that the lab test price reporting under the Patient Access to Medicare Act of 2014 will have a negative effect on diagnostic innovation and on Medicare beneficiaries’ access to lab testing services. The American Clinical Laboratory A…
California’s Lab Price Data Collection Project Cuts Lab Test Prices by 10.5%
COLLECTING LAB TEST PRICE DATA is not limited to PAMA and the federal Centers for Medicare & Medicaid Services. California’s Medi-Cal program is in its second year of requiring clinical labs to submit private payer lab test price data. However, in both the fir…
Why Small Labs and Even Hospitals Are at Risk from PAMA Cuts
CEO SUMMARY: Clinical lab executives and experts who have studied the final rule for PAMA lab test market price reporting are seriously concerned that the design of this rule may put many of the nation’s smallest, but still essential, clinical labs at great risk of financial distress, i…
Brooklyn Toxicology Lab Suspended for 30 Days by NY Department of Health
IN BROOKLYN, N.Y., a toxicology laboratory has been shut down temporarily since Sept. 9 by order of the New York State Department of Health. The lab was cited for failing to perform calibration and quality control procedures properly, The lab company is Advanced Clinical Laboratory Solutions…
First CAP 15189 Accreditation for a Children’s Hospital Lab
CEO SUMMARY: It’s now official. St. Jude Children’s Research Hospital is the first children’s hospital to earn accreditation to ISO 15189 under the College of American Pathologists. What is more interesting, however, is how lab leadership used the quality management system of ISO 15…
Theranos Now Scrambling To Save What It Can
CEO SUMMARY: On July 7, CMS imposed severe sanctions on Theranos for CLIA violations. Included is a two-year ban on owning and operating a clinical laboratory for Theranos, CEO Elizabeth Holmes, the former COO, and the former medical director. Theranos appears to be pivoting away from a c…
July 5, 2016 Intelligence: Late Breaking Lab News
More developments have happened at Theranos, Inc., the beleaguered clinical lab company based in Palo Alto, California. On June 24, Brook Buchanan, Vice President of Communications at Theranos, resigned, giving personal reasons for the decision. Buchanan was hired in November 2015, …
PAMA Final Rule Issued, CMS Plans to Cut Rates by 5.6%
CEO SUMMARY: CMS issued its final rule for implementing the laboratory payment reform included in the Protecting Access to Medicare Act of 2014 (PAMA) on June 17. All labs will see significant reductions to the Medicare Part B Clinical Laboratory Fee Schedule that becomes effective on Jan…
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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