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clinical laboratory test
Will 2016 Bring Opportunity or Tribulations for Labs?
By R. Lewis Dark | From the Volume XXII No. 15 – October 26, 2015 Issue
WE ARE JUST ABOUT EIGHT WEEKS FROM THE ADVENT OF 2016. Given the rapid transformation of healthcare that continues to unfold, it is timely to assess how clinical labs and pathology groups are likely to fare during the coming year. On the plus side, the ongoing evolution toward integration of clinica…
WSJ ‘Sticks’ Theranos, Raises Serious Questions
By Robert Michel | From the Volume XXII No. 15 – October 26, 2015 Issue
CEO SUMMARY: Following months of investigation, reporter John Carreyrou of The Wall Street Journal published back-to-back reports about aspects of Theranos that the…
New ADLT Payment Rate May Force Lab to Close
By Joseph Burns | From the Volume XXII No. 15 – October 26, 2015 Issue
CEO SUMMARY: Four Medicare Administrative Contractors currently pay $2,821 for CareDx’s AlloMap test. But under the proposal that CMS issued last month to overhaul the clinical lab fee schedule, CareDx would get only $644. Such a steep price cut would put the lab out of business because…
New DAT Law, Competition Heat Up Phoenix Market
By Joseph Burns | From the Volume XXII No. 15 – October 26, 2015 Issue
CEO SUMMARY: In Arizona, Theranos supported a new state law this year that allows patients to order lab tests without a doctor’s order. Since the law took effect, that law and the ultra-low prices offered by Theranos are drawing away some cash-paying customers from one lab company that …
Lab Professionals Knew of Challenges at Theranos
By Robert Michel | From the Volume XXII No. 15 – October 26, 2015 Issue
CEO SUMMARY: For most of the past year, pathologists and medical laboratory professionals in the San Francisco and Phoenix markets were aware that Theranos was not delivering to patients and consumers the specific lab testing services it regularly touted in news stories and at conferences…
Did Some Lab Execs ‘Get What They Wished For?’
By R. Lewis Dark | From the Volume XXII No. 14 – October 5, 2015 Issue
BY NOW, MOST OF YOU HAVE LEARNED that, just 12 days ago, CMS issued the proposed rule that details how it will handle the private market price reporting mandate of the Protecting Access to Medicare Act of 2014 (PAMA). Almost immediately, critics spoke out about the obvious inequities that will re…
Tasso’s Device Collects Capillary Blood for Testing
By Joseph Burns | From the Volume XXII No. 14 – October 5, 2015 Issue
CEO SUMMARY: In Seattle, Tasso Inc., a start-up company, is developing a device that adheres to the skin and collects capillary blood that can be used for lab testing. Tasso says the device is a less invasive than a venipuncture. At the same time, executives at Tasso recognize that, for m…
Feds Show How Labs Took $500 Million from Medicare
By R. Lewis Dark | From the Volume XXII NO. 13 – September 14, 2015 Issue
CEO SUMMARY: In this second phase of the whistleblower case against three cardiology testing labs and a sales consulting company, federal prosecutors are requesting a jury trial against the individuals named in the court documents filed August 7. Federal investigators alleged t…
New Developments in $1 Billion Lab Fraud Case
By R. Lewis Dark | From the Volume XXII NO. 13 – September 14, 2015 Issue
CEO SUMMARY: Court documents filed last month in the federal qui tam case against Health Diagnostic Laboratory, Singulex, Berkeley Heart Lab, BlueWave Healthcare Consultants, and several lab executives allege that the defendants used illegal inducements and kickbacks to file false c…
Is New Cycle of Laboratory Fraud Plaguing the Industry?
By Mary Van Doren | From the Volume XXII No. 12 – August 24, 2015 Issue
CEO SUMMARY: Taken collectively, the growing number of federal investigations of lab companies and health insurer lawsuits against lab companies alleging fraudulent busine…
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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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