TAG:
clia
July 25, 2016 Intelligence: Late Breaking Lab News
Throughout the profession of laboratory medicine, concern is surfacing following publication of a proposed rule by the Department of Veterans Affairs (VA) that would expand the authority of Advanced Practice Registered Nurses (APRNs) to supervise and perform laboratory testing. This …
CMS CLIA Sanction Letter Sent To Theranos Raises Questions
CITING PRACTICES THAT JEOPARDIZE PATIENT SAFETY, the federal Centers for Medicare & Medicaid Services decided earlier this month to revoke the CLIA certificate that it granted to Theranos Inc. to operate a clinical laboratory in Newark, Calif., and to ban the lab…
Theranos Now Scrambling To Save What It Can
CEO SUMMARY: On July 7, CMS imposed severe sanctions on Theranos for CLIA violations. Included is a two-year ban on owning and operating a clinical laboratory for Theranos, CEO Elizabeth Holmes, the former COO, and the former medical director. Theranos appears to be pivoting away from a c…
Of Theranos, ADLTs, and Surgical Pathology Errors
THESE DAYS, IT SURE FEELS LIKE CLINICAL LABS AND PATHOLOGY GROUPS are under constant siege. Every month seems to bring one or more new developments that rock the clinical lab industry. Thera…
PAMA Final Rule Issued, CMS Plans to Cut Rates by 5.6%
CEO SUMMARY: CMS issued its final rule for implementing the laboratory payment reform included in the Protecting Access to Medicare Act of 2014 (PAMA) on June 17. All labs will see significant reductions to the Medicare Part B Clinical Laboratory Fee Schedule that becomes effective on Jan…
California Lab Company Offers Genetic Tests with Low Prices
ONE BY ONE, A HANDFUL OF PROGRESSIVE LAB COMPANIES is finding financial success with a strategy of pricing genetic tests at levels that are affordable and attractive to the general public. These labs report an added benefit: They find it easier to get health insurers to pay their genetic test claims….
Walgreens Tells Theranos: ‘Lab Deal Is Terminated’
BREAKING NEWS: As this issue of THE DARK REPORT went to press, it was learned that Walgreens had announced the termination of its lab testing agreement with Theranos, effective immediately. Theranos loses access to about 40 Walgreens pharmacies in Phoe…
Why Theranos Is a Big Test for CMS and CLIA
OFFICIALS AT THE FEDERAL CENTERS FOR MEDICARE & MEDICAID SERVICES are at what may be the most important crossroads in the history of clinical laboratory regulation since Congress passed the CLIA 1988 legislation. Will CMS pursue the severe sanctions it disclosed to Theranos, Inc.,…
Up to 30,000 Theranos test results voided; Walgreen dumps partnership
This is an excerpt from a 1,000-word article in the June 13 issue of THE DARK REPORT. The original article is available to paid members of the Dark Intelligence Group. …
Do Regulators Really Protect Patients, Consumers?
IMAGINE, FOR A MOMENT, THAT ONE OF YOUR LOVED ONES had gone to Theranos during the past two years to get lab tests. Assume that your loved one was being tested for significant biomarkers that directly affected the care provided to your family member for significant health issues and that your loved o…
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.