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Market Price Report Rules Must Address All Issues
CEO SUMMARY: Under the Protecting Access to Medicare Act, CMS must collect market price and volume data from certain labs beginning January 1, 2016. CMS will use this data to establish Part B clinical laboratory fees beginning in 2017. One lab association representing community a…
February 17 Intelligence: Late Breaking Lab News
GeneCentric is a new lab testing company in Durham, North Carolina that was started by former executives of Laboratory Corporation of America. It intends to raise $20 million in a Series B capital offering. GeneCentric’s business model is to license molecular diagnostic tests, then develop the…
Meaningful Use Stage 2 Is Problem for EHR Firms
CEO SUMMARY: EHR system vendors must now comply with the federal government’s Meaningful Use Stage 2 requirements. Well-established EHR vendors will survive. But smaller EHR companies may struggle to provide the enhancements to their first generation EHR products that are require…
January 26, 2015 Intelligence: Late Breaking News
Interesting things are happening in the commercial clinical lab testing market internationally. In New Zealand, district health boards continue a decadeslong trend of squeezing commercial lab companies with the goal of reducing laboratory testing costs and eliminating redundancies. Currently the dist…
Florida Pathologists Critical of UnitedHealth and BeaconLBS
CEO SUMMARY: In a letter to UnitedHealthcare, the Florida Society of Pathologists says UHC’s pilot laboratory management program will have a negative effect on patient care by delaying access to care and timely diagnoses of disease. Signed by more than 120 members…
Why ‘Bad Actors’ Continue to Operate in Lab Industry
OVER THE PAST TWO DECADES, pathologists and lab managers have regularly watched certain new lab companies burst on the scene and generate startling growth in revenue and profits by offering proprietary tests–often unsupported by published clinical studies that …
Is PAML to Be Sold? ‘No Comment!’ Say Execs
CEO SUMMARY: It is one of the 10 largest lab companies in the United States. Thus, if Pathology Associates Medical Laboratories in Spokane, Washington, were to be sold, it would trigger a major shift in the competitive market for lab testing service…
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…
Preparing the Next Generation of Lab Leaders
ACROSS THE LAB TESTING INDUSTRY, individual labs are caught in a serious conundrum. On one hand, the ongoing transformation of healthcare and the erosion of lab test revenues are putting the financial squeeze on a large number of clinical labs and pathology groups. On the other hand, at the very mom…
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…
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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