TAG:
the clinical laboratory
Theranos implosion was the first Big Story of 2016
This is an excerpt from a 3,200-word article in the December 19 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. …
Revisiting the ‘Substantially in Excess Rule’
BY NOW, NEARLY EVERY LAB MANAGER knows that Medicare lab test fee cuts will commence in just 13 months, on Jan. 1, 2018. The federal Centers for Medicare & Medicaid Services estimates that the f…
Much Disruption for Labs In 2016’s Top 10 Stories
CEO SUMMARY: Within THE DARK REPORT’S list of the Top 10 Lab Industry Stories for 2016 is one story of disruption that might have been one story of disruption about to happen. The disintegration of Theranos during 2016 is the big story about a self-proclaimed disruptor of the lab indust…
Should Labs File Court Challenge To PAMA Price Report Rule?
CEO SUMMARY: Just four weeks remain before CMS begins collecting private payer clinical laboratory test price data. Many lab industry executives have charged that Medicare officials are not following the language of the PAMA statute or the intent of Congress. At stake are $5.4 billion in …
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…
Labs Discover Much Complexity In Their Lab Test Price Data
DON’T EXPECT IT TO BE EASY AND STRAIGHTFORWARD when reporting the prices of chemistry panels as the final rule for lab test market price reporting rule requires. Instead, labs should expect the process to be complex and troublesome. Also, labs should be concerned that Medicare officials have threa…
OIG Comments on PAMA Plan and Exclusion of Many Labs from Reporting
ON THE SUBJECT OF LAB TEST MARKET PRICE REPORTING as required under PAMA, many clinical laboratory executives, pathologists, and industry experts see deep flaws in the process the federal Centers for Medicare & Medicaid Services has established. Yet, CMS itself seems blind to the…
Test price data shows major difference between Medicare lab fee schedule and private payers
This is an excerpt from a 1,500-word article in the November 7 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: THE DA…
Labs Have Heavy Burden to Report Lab Price Data
CEO SUMMARY: Clinical labs must assess their responsibilities to report lab test market prices to CMS as part of the Protecting Access to Medicare Act. A panel of three experts took up this topic at a recent webinar hosted by THE DARK REPORT. On June 23, the federal Centers for Medicaid &…
XIFIN Analysis of Its Real Price Data Shows Hospital Lab Price Effect
CEO SUMMARY: In a new analysis of data its lab clients will use to report market prices to CMS, XIFIN Inc., reports private payers paid independent labs a weighted average price that was 19.6% less than what Medicare pays for 20 of its highest-volume tests. By contrast, private payers pa…
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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