By Joseph Burns, from the Volume XXV, No. 2 – January 22, 2018 issue
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 minor changes to the rules
By Joseph Burns, from the Volume XXIII No. 10 – July 25, 2016 issue
IT’S GOING TO BE A DIFFERENT AND TOUGHER WORLD for laboratory companies that market proprietary molecular and genetic tests. That’s the opinion of experts who have studied the final rule governing Advanced Diagnostic Laboratory Tests (ADLTs) that the federal Centers for Medicare & Medicaid Services issued in June.
The final rule implements Section 216 of the
By Joseph Burns, from the Volume XXIII No. 10 – July 25, 2016 issue
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 clinical lab testing business strategy and back to
By Mary Van Doren, from the Volume XXIII, No. 6 - May 2, 2016 issue
IT’S BEEN AN EVENTFUL COUPLE OF MONTHS for Theranos, the lab testing company that says its goal is to disrupt the clinical laboratory industry. Novelists cannot write fiction as compelling as the unfolding real story about this controversial company.
During March and April, The Wall Street Journal published a series of articles that revealed the extent of the problems Theranos had with CLIA inspections of its clinical laboratory in Newark, California. The Journal published its analysis of the CLIA inspection report and the serious deficiencies identified during lab inspections that happened last fall and earlier this year.
By Robert Michel, from the Volume XXII NO. 16 - November 16, 2015 issue
CEO SUMMARY: Recent disclosures in the news indicate that an agreement between Theranos and Safeway has gone sour— after Safeway spent a third of a billion dollars to fulfill its part of the collaboration! Reporting by The Wall Street Journal claimed that Theranos and Safeway are negotiating over this situation. If the two parties cannot
By Joseph Burns, from the Volume XXII NO. 3 - February 17, 2015 issue
CEO SUMMARY: An interesting milestone for the clinical lab industry is on the horizon. Physicians Choice Laboratory Services in South Carolina will soon become one of the first lab organizations in the United States to earn joint CLIA and ISO 15189 accreditations with the American Association of Laboratory Accreditation (A2LA). While it was undergoing ISO 15189 accreditation, the organization began to prepare for CLIA accreditation through A2LA, both for a single price.
See additional Dark Daily coverge on CLIA and A2LA certification
By Joseph Burns, from the Volume XXI No. 15 - November 3, 2014 issue
CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucratic oversight of LDTs. The FDA said that this new layer of regulation will be phased
By Robert Michel, from the Volume XXI NO. 14 - October 13, 2014 issue
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 that patients with chronic conditions will have
By Joseph Burns, from the Volume XXI NO. 10 - July 21, 2014 issue
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 management program will commence on October 1, 2014. Just 13 laboratories are currently listed as network
By Robert Michel, from the Volume XXI NO. 7 – May 19, 2014 issue
How about a hospital that doesn’t have a medical laboratory but issues lab test reports to patients? This unusual development happened in India recently. The Free Press Journal of Mumbai, India, reported earlier this month that government health officials had conducted a surprise inspection of the City Hospital at MP Nagar, Bhopal. Inspectors found that,
