TAG:
laboratory tests
Letter from Congress to CMS Asks for Delay in PAMA Reporting
CLINICAL LABORATORY ASSOCIATIONS are using a letter-writing campaign to members of Congress as a last-minute Hail Mary attempt to head off the controversial lab price market reporting rule that CMS intends to implement after January 1. Both Democrats and Republicans in the U.S. House of Representati…
2015’s Top 10 Lab Stories Show Significant Changes
CEO SUMMARY: During 2015, two stories captured the full attention of most pathologists and clinical lab managers. One was how CMS intends to gather lab price market data as mandated by PAMA. The other was the continued efforts by the FDA to move ahead on proposed guidance for regulation o…
Cleveland Clinic and related lab sue True Health Diagnostics
THE DARK REPORT is the only lab industry news source to recognize the significance of the lawsuit between the Cleveland Clinic Foundation and Cleveland HeartLab against a new lab company, True Health Diagnostics. It is the latest chapter in a string…
Toxicology Lab Millennium Pays $256M to DOJ, Files For Bankruptcy
IN ANOTHER MAJOR LAB FRAUD CASE, toxicology lab company Millennium Health will pay $256 million to settle allegations in a whistleblower lawsuit that it overbilled federal healthcare programs for unnecessary lab testing. Just 22 days after this agreement, Millennium Health filed a pe…
DAT: Should Patients Have Access to All Laboratory Tests?
CEO SUMMARY: Arizona’s new direct access testing law allows consumers and patients to have access to all laboratory tests without a physicians’ order. But one lab company decided not to offer all lab tests to consumers. Instead, executives at Sonora Quest Laboratories recognize that, …
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…
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…
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…
Will 2016 Bring Opportunity or Tribulations for Labs?
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…
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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