TAG:
the clinical laboratory
33 Groups Cooperated to Get PAMA-Related LAB Act Passed
>CEO SUMMARY: At the end of 2019, the Laboratory Access for Beneficiaries (LAB) Act became law and addressed two of the three most onerous requirements in the Protecting Access to Medicare Act (PAMA) of 2014. It delays the data-reporting requirements under PAMA, an…
How Northwell’s Lab Team Demonstrated Value Over 10 Years
CEO SUMMARY: Among hospital administrators, the popular wisdom is that their clinical lab is a cost center. This thinking leads them to consider drastic cost-management strategies that include partnering with commercial labs to manage in-hospital lab testing and the outright sale of lab o…
Lawsuits Alleging Overcharges to Proceed in Two Courts in 2020
CEO SUMMARY: Two lawsuits filed in federal courts against Laboratory Corporation of America and Quest Diagnostics may have consequences for the entire lab industry. The plaintiffs are patients who allege that the two defendant lab companies charged them as much as 10 times more than what …
2019’s Top 10 Lab Stories Reveal Major Laboratory Industry Trends
This is an excerpt of a 3,163-word article in the Dec. 16, 2019 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: There was plenty of bad news in 2019 for clinical labs and pathology groups. Yet lurking inside this new…
ASCP, CAP Ask Anthem to Roll Back Price Cuts
CEO SUMMARY: One association representing pathologists says new payment rates that Anthem, Inc., is introducing in 14 states do not cover the costs of performing anatomic pathology and clinical lab testing for the tests in question. Another association says the steep payment cuts threaten…
September 23, 2019 Intelligence: Late Breaking Lab News
Spectra Laboratories, a division of the national dialysis company Fresenius Medical Care, will soon open a new 200,000 square foot laboratory facility in Memphis. The new lab will employ more than 300 people and will be located only 15 minutes from the Memphis Intern…
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…
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…
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…
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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