TAG:
lab tests
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…
Concerns Raised Over Pharmacogenetic Tests
CEO SUMMARY: Some executives at pharmacogenetic testing companies are criticizing the federal Food and Drug Administration for its recent actions to exercise oversight over PGx testing. But there is more to the story, said one expert who is a past adviser to the FDA on clinical laboratory…
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 …
How Lab Fraud Hurts Hospital Labs, Pathologists
ONCE AGAIN, A HIGH-PROFILE LAB COMPANY faces allegations of fraud and abuse. This time it is True Health Diagnostics of Frisco, Texas. Details of this case were revealed last month when True Health filed a lawsuit in a federal court in Texas against the agencies running the federal M…
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…
Aetna Ends Payment for Professional Component
CEO SUMMARY: As of Aug. 1, Aetna will stop paying out-of-network pathologists for the professional component review of certain clinical pathology tests. Until now, the health insurer has paid for the professional component when out-of-network labs billed for clinical lab tests using the m…
May 20, 2019 Intelligence: Late Breaking Lab News
Canada faces a similar shortage of medical technologists (MTs) as exists in the United States. “We have reached the point now where some laboratories have been closed for weeks due to insufficient staffing, which is a cascading problem for patients and the healthcare system,” stated Maria Klement…
What Labs Can Expect from PAMA in 2019
CEO SUMMARY: Attendees at the Executive War College learned that CMS has taken steps to expand the number of hospital labs required to report their private payer lab test price data under the Protecting Access to Medicare Act, but the unbundling of certain test panels could be problematic…
The Bad News: Disruption. The Good News: Opportunity!
CEO SUMMARY: There was an interesting consensus that emerged from the 80 sessions and 118 speakers at this year’s Executive War College in New Orleans earlier this month. The consensus centered around two themes. One theme is disruption, which is bad news for those labs that hope to mai…
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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