TAG:
clia
Labs Working to Release Test Results to Patients
CEO SUMMARY: A new federal requirement requires labs to make test results available to patients beginning this month. What is unknown is how patients will respond to the opportunity to see their lab test results. The effective date for this new requirement was October 6. It is expected th…
October 13, 2014 “Intelligence: Late-Breaking Lab News”
Quality management systems (QMS) have made inroads in some of the organizations that accredit clinical laboratories in the United States to the requirements of CLIA. Last month, COLA of Columbia, Maryland, acknowledged that it had recertified to the standards of ISO 9001: 2008. The r…
Aetna Files Suit against NJ Lab, Plans to Sue Two More Labs
FINALLY, A MAJOR HEALTH INSURER IS taking a hard line against clinical laboratories it suspects of committing fraud. Aetna Health, Inc., and Aetna Life Insurance Company, of Hartford, Connecticut, have sued one lab company and included physicians as defendants in tha…
Pathologist Raises Questions about Theranos’ Business Model
Dear Editor: I read your two articles on Theranos in the August 11 issue of THE DARK REPORT, and concur in large part with your thoughtful conclusions. For several years, I have closely followed Theranos and have been quoted in trade publications speaking favorably…
My Visit to Walgreens for Theranos Lab Tests
CEO SUMMARY: One of the biggest unknowns in the lab testing industry today is Theranos, the lab testing company based in Palo Alto, California. It says its proprietary technology is poised to transform the lab testing experience for patients and physicians. It says it can perform hundreds…
FDA Notifies Congress that It Will Regulate LDTs
CEO SUMMARY: Since 2006, the FDA has said it has the authority to regulate lab-developed tests, but it has held off on doing so. Now the agency says it’s time, defining LDTs as being, “designed, manufactured, and used within a single laboratory. LDTs include some genetic tests and tes…
Test Utilization Targeted by UnitedHealth, LabCorp
CEO SUMMARY: Many independent laboratories serving patients in Florida are unhappy about the decision by UnitedHealth (UNH) to initiate a pilot program that calls for LabCorp’s BeaconLBS subsidiary to handle prior authorization for certain lab tests. UNH’s laboratory benefit managemen…
Labs Wary of BeaconLBS, Express Major Concerns
CEO SUMMARY: Lab executives asked to join UnitedHealth’s new BeaconLBS lab benefit management system soon to launch in Florida have multiple and serious concerns. The primary issue is that BeaconLBS is a subsidiary of LabCorp—their major competitor. These executives understand why a p…
PAMA’s New Rules Affect Lab Test Pricing, Coverage
CEO SUMMARY: For several reasons, the “Protecting Access to Medicare Act” (PAMA) has the potential to be the most disruptive federal legislation directed at the clinical lab industry since the enactment of CLIA 1988. Following passage of the law, some lab industry groups have taken di…
Speakers in New Orleans Offer Important Insights
CEO SUMMARY: In coming years, there will be multiple challenges and opportunities for the nation’s clinical laboratories and pathology groups. That was one common theme heard from the 90 speakers and panelists at the 19th annual Executive War College on Laboratory and Pathology Manageme…
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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