TAG:
clinical laboratories
PGx Testing Labs Concerned by FDA’s Statements, Actions
This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) ha…
PGx Labs Concerned by FDA’s Statements, Actions
CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to ce…
September 3, 2019 Intelligence: Late Breaking Lab News
Two more clinical laboratory organizations that used American Medical Collection Agency (AMCA) to handle their lab test claims announced in July that their patients’ data was breached. Inform Diagnostics of Irving, Texas, disclosed that the data of 173,716 patient…
After Two-Year Battle with CMS, True Health on Verge of Collapse
CEO SUMMARY: In 2017, an auditor for CMS alleged that True Health filed fraudulent claims and the federal Medicare program cut all payments to the lab company and one month later reduced the cut to 35% of the billed amount. Two months ago, CMS ended all payments again. These facts became …
In New Mexico, Three Collaborators Improve Patient Care, Outcomes
IT’S OFFICIAL! A YEAR-LONG COLLABORATION involving a health insurer, a clinical laboratory, and an analytics company showed that insurers and physicians can use clinically-actionable intelligence developed from medical lab test data to improve patient outcomes. This important accomplishment in patie…
ACLA Gets Procedural Win in Its Appeal of PAMA Case
IN A SIGNIFICANT WIN for the American Clinical Laboratory Association (ACLA) and other groups suing federal Department of Health and Human Services (HHS), the U.S. Court of Appeals for the District of Columbia ruled in the ACLA’s favor on July 30. Ruling on the ap…
After Two-Year Battle with CMS, True Health Diagnostics on Verge of Collapse
This is a synopsis of three in-depth articles in the Aug. 12, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: In 2017, an auditor for CMS alleged that True Health Diagnostics f…
CMS Sanctioned Three Houston Hospitals, Labs
CEO SUMMARY: At MD Anderson Cancer Center and Baylor St. Luke’s Medical Center, blood transfusion errors led to two patients’ deaths in separate incidents last fall. Then, this spring, a patient died in the emergency department of Ben Taub Hospital following “an ineffective process …
By 2025, the Millennial Generation Will Dominate Lab, Pathology Workforce
This is an excerpt of a 2,576-word article in the July 22, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Within five years, members of the millennial generation will make up 75% of the physician workforce in…
By 2025, Millennials Will Dominate Lab, Pathologist Workforce
CEO SUMMARY: Within five years, members of the millennial generation will make up 75% of the physician workforce in the United States, rising from about 24% in 2017. That three-fold increase represents a strong demographic trend that will require changes in the steps all clinical laborato…
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.
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.