TAG:
clia-certified laboratory
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…
Amazon Now Interested in Home Testing Services
CEO SUMMARY: In the past year, internet retailing giant Amazon has built sizeable clinical laboratories in the United States and the United Kingdom. Now it has regulatory clearance to sell a molecular COVID-19 test to consumers for home collection. Comments made in the past month by…
CLIA Lab Inspections Different Because of COVID-19 Pandemic
WITH THE ONSET OF THE COVID-19 PANDEMIC IN MARCH, three of the major organizations deemed to have CLIA status suspended inspections of clinical laboratories for several months. Inspections and assessments of laboratories have restarted, but with significant changes because of the SARS-CoV-2 outbreak….
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…
Lab’s Low Gene Test Price Gets Insurers’ Attention
CEO SUMMARY: At a time when most molecular and genetic testing companies are struggling to gain coverage for their tests, this Silicon Valley-based lab company has become an in-network lab provider for a number of health insurers—including three of the nation’s largest payers. It did …
California company shows labs the way with low genetic testing cost
This is an excerpt from a 1,485-word article in the June 5, 2017 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: At a time when most molecular and gene…
Walgreens To Go National with Lab Tests in Stores
CEO SUMMARY: A disruptive innovation is one that shakes up an entire market or industry. By adding clinical lab testing to its health services offerings in more than 8,100 stores nationwide, Walgreens could disrupt the status quo in the clinical lab industry. Walgreens says its lab partne…
Theranos Won’t Discuss Disruptive Lab Technology
CEO SUMMARY: In a partnership with Walgreens pharmacies, Theranos Inc. announced that it will run clinical lab tests on “micro-samples” and collect these blood samples without venipuncture. Even as Theranos touts the patient-friendly benefits of its proprietary diagnostic technology, …
Medicare Contractor’s Ruling on MolDx Test Causes Lab to Close
CEO SUMMARY: On May 14, Predictive Biosciences learned that its Medicare contractor had determined that one of its three molecular tests for bladder cancer was a screening test. It also never got a determination on its other two molecular tests. Because Medicare is half of the lab’s pay…
Docs’ In-Office Testing Showing Mixed Trends
CEO SUMMARY: Despite the burdens of CLIA certification and reduced reimbursement for lab tests, many medical practice experts are advising doctors to expand in-office testing. However, diagnostic technologies for near-patient testing are still not robust enough to support this trend. Earl…
CURRENT ISSUE
Volume XXX, No. 7 – May 8, 2023
The Dark Report examines how the acquisition of Geisinger Health by Kaiser Permanente not only sets the stage for more blockbuster hospital deals, but offers a platform for new value-based reimbursement models. Also in this issue, payers are seeking ever more documentation before they’ll pay lab test claims.
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