TAG:
laboratory test
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…
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…
Labs React with Criticism to Proposed ADLT Rule
CEO SUMMARY: Some in the lab industry had high hopes that passage of the Protecting Access to Medicare Act (PAMA) last year would favorably resolve a number of important issues. However, those hopes were dashed following the September 25 release by CMS of a proposed rule setting out how i…
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…
New DAT Law, Competition Heat Up Phoenix Market
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 …
Did Some Lab Execs ‘Get What They Wished For?’
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…
CMS Releases Draft of PAMA Market Price Rule
CEO SUMMARY: CMS’ proposed rule details how it will collect private market data, then use that data to establish prices for the Medicare Part B Clinical Laboratory Fee Schedule beginning in 2017. The proposed rule will limit data reporting to les…
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 …
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…
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…
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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