TAG:
clinical laboratory improvement amendments
Congress May Soon Act on IVCT, LDT Regulation
This is an excerpt of a 2,017-word article in the November 29, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Congress is gearing up for a debate on …
CLIA Lab Director Testimony Shows Risks to Pathologists
CEO SUMMARY: Elizabeth Holmes’ criminal trial is a case study for clinical lab directors in how not to run a medical lab, according to an attorney with 30 years of advising labs on CLIA-enforcement issues. During the trial, federal prosecutors cited the Clinical Laboratory Improve…
CAP Introduces Features to Aid CLIA Inspections
CEO SUMMARY: Clinical labs are changing in multiple ways and the College of American Pathologists regularly revises its CLIA accreditation processes in response to these changes. One such change is the growth in the number of integrated delivery networks that operate multiple hospit…
CLIA Accreditation Market: More Competitive Now?
CEO SUMMARY: It’s been three decades since compliance with the Clinical Laboratory Improvement Amendments (CLIA) became mandatory. During that time, there has been little competition among the major organizations with deeming status by the Medicare Program to accredit labs to CLIA…
CMS Shuts Missouri Lab Due to ‘Immediate Jeopardy’
CEO SUMMARY: CMS ordered Gamma Healthcare to close its two labs, revoked the owners’ CLIA licenses, prohibited them from operating a lab for two years, and ordered payment of more than $55,000 in civil penalties. The two lab facilities had been running COVID-19 and other tests for…
After Two Decades, CMS Wants to Update CLIA Lab Regulations
IN THE FIRST EFFORT OF ITS kIND in more than two decades, the federal Centers for Medicare and Medicaid Services has published a request for information (RFI) in the Federal Register as a first step to revise the CLIA rules it promulgated in 1992. Over the years, CMS has made some m…
ADLT Final Rule Creates Tough Questions for Labs
IT’S GOING TO BE A DIFFERENT AND TOUGHER WORLD for laboratory companies that market proprietary molecular and genetic tests. That’s the opinion of experts who have studied the final rule governing Advanced Diagnostic Laboratory Tests (ADLTs) that the federal Centers for Medicare & Med…
Theranos Now Scrambling To Save What It Can
CEO SUMMARY: On July 7, CMS imposed severe sanctions on Theranos for CLIA violations. Included is a two-year ban on owning and operating a clinical laboratory for Theranos, CEO Elizabeth Holmes, the former COO, and the former medical director. Theranos appears to be pivoting away from a c…
Theranos Saga Just Keeps Getting More Intriguing
This is an excerpt from a 400-word article in the May 2 issue of THE DARK REPORT. The complete article is available paid members of the Dark Intelligence Group. …
Might Lawsuits Come Next in Theranos Story?
CEO SUMMARY: Recent disclosures in the news indicate that an agreement between Theranos and Safeway has gone sour— after Safeway spent a third of a billion dollars to fulfill its part of the collaboration! Reporting by The Wall Street Journal c…
CURRENT ISSUE
Volume XXXII, No. 1 – January 6, 2025
The Dark Report examines how AI is being used to predict the outcomes of FDA LDT lawsuits. Also, this issue is Part Two of a series about boosting pathology compensation in different settings, including hospitals. Two experienced pathology consultants identify the most effective approaches when negotiating Part A pathology agreements with hospitals and health systems, along with how to use data to bolster these negotiations.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.