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New ADLT Payment Rate May Force Lab to Close
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…
Lab Professionals Knew of Challenges at Theranos
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…
WSJ ‘Sticks’ Theranos, Raises Serious Questions
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…
Tasso’s Device Collects Capillary Blood for Testing
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…
Labs Have Questions for CMS on Proposed Rule
CEO SUMMARY: On September 25, CMS took a long overdue step to issue a proposed rule on how medical laboratories are to report private market prices for lab tests to the Medicare program during 2016. The proposed rule provides insights as to how CMS envisions pricing new tests and advanced…
October 5, 2015 Intelligence: Late Breaking Lab News
More venture capital money is moving into the medical laboratory industry in India. In September, Metropolis Healthcare Ltd of Mumbai, India, disclosed that Carlyle, a private equity company, had purchased a 36.5% ownership interest in the lab company. In April, Warburg Pincus …
Hospital Lab Shares Ten Ways to Create Value with Lab Tests
CEO SUMMARY: Across the nation, labs in hospitals and health systems are feeling pressure from shrinking lab budgets and the need to be a contributor to the integration of clinical care. At Henry Ford Health System in Detroit, the clinical laboratory and department of pathology have respo…
Isn’t It Time for More Criminal Prosecutions of Lawbreakers?
WILL FEDERAL PROSECUTORS BE PLAYING ANOTHER ROUND of the game “whack a mole” with some of the same principals and clients of Health Diagnostic Laboratory and Bluewave Healthcare Consultants? These are individuals who figured prominently in the ongoing federal whistleblower cases allegin…
Meet Richest Sales Reps In Lab Testing Industry
CEO SUMMARY: Without much fanfare, two individuals who had been sales representatives at Berkeley HeartLab as late as 2009, took distributions of $58 million each between 2010 and 2014 for their sales consulting services at BlueWave Healthcare Consultants, according to allegations in the fe…
Detroit Hospital Develops 10 Ways To Add More Value
CEO SUMMARY: Clinical labs are beginning to make the transition from a volume-based financial model to a model based on value-based payments. To survive this transition, labs must find ways to create value. The lab at Henry Ford Health System has  identified 10 ways that it c…
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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