TAG:
clinical laboratory test
Letter from Congress to CMS Asks for Delay in PAMA Reporting
CLINICAL LABORATORY ASSOCIATIONS are using a letter-writing campaign to members of Congress as a last-minute Hail Mary attempt to head off the controversial lab price market reporting rule that CMS intends to implement after January 1. Both Democrats and Republicans in the U.S. House of Representati…
2015’s Top 10 Lab Stories Show Significant Changes
CEO SUMMARY: During 2015, two stories captured the full attention of most pathologists and clinical lab managers. One was how CMS intends to gather lab price market data as mandated by PAMA. The other was the continued efforts by the FDA to move ahead on proposed guidance for regulation o…
Cleveland Clinic and related lab sue True Health Diagnostics
THE DARK REPORT is the only lab industry news source to recognize the significance of the lawsuit between the Cleveland Clinic Foundation and Cleveland HeartLab against a new lab company, True Health Diagnostics. It is the latest chapter in a string…
UnitedHealthcare Comments on Labs’ Use of “Fee Waivers”
PATHOLOGISTS AND LAB SCIENTISTS are familiar with the well-known scientific principle that, “for every action, there is a reaction.” This principle also holds true for the managed care contracting practices of the two national laboratory companies. One action that is the subject of this story is…
Opportunities Ahead for Labs That Prepare
AT THE END OF EVERY YEAR, IT’S ALWAYS SMART BUSINESS FOR EVERY LAB to peer into the future specifically to identify the best clinical and financial opportunities. With the New Year just a few week…
Coming Next Year for Labs: PAMA, FDA, LDTs, and More
CEO SUMMARY: As 2016 approaches, nearly every lab organization is watching and waiting to learn how federal regulators at CMS and the FDA will move forward with plans to implement PAMA market reporting and regulation of laboratory-developed tests, respectively. Most knowledgeable observer…
State of Clinical Lab Industry Likely to Be Mixed in 2016
CEO SUMMARY: Over the next 24 months, it will be essential for every clinical laboratory and anatomic pathology group to develop clinical and financial strategies that meet the changing needs of health insurers, hospitals and health systems, physicians, and patients. THE DARK REPORT provi…
Might Lawsuits Come Next in Theranos Story?
CEO SUMMARY: Recent disclosures in the news indicate that an agreement between Theranos and Safeway has gone sour— after Safeway spent a third of a billion dollars to fulfill its part of the collaboration! Reporting by The Wall Street Journal c…
DAT: Should Patients Have Access to All Laboratory Tests?
CEO SUMMARY: Arizona’s new direct access testing law allows consumers and patients to have access to all laboratory tests without a physicians’ order. But one lab company decided not to offer all lab tests to consumers. Instead, executives at Sonora Quest Laboratories recognize that, …
New Company Targets Lab Benefit Management
CEO SUMMARY: Soon, the nation’s newest laboratory benefit management company will begin working for Blue Cross Blue Shield of South Carolina. Avalon Healthcare Solutions committed to BCBSSC that it can save money off what the health plan has been spending on clinical lab testing. It wil…
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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