By Joseph Burns, from the Volume XXV No. 3 – February 12, 2018 issue
CEO SUMMARY: For many years, NILA has urged the federal Centers for Medicare and Medicaid Services to make significant changes in CLIA regulations. Yet, in its recent request for information, CMS addressed five specific areas. But the federal agency left out the need for a comprehensive overhaul of the CLIA regulations in other areas, including
By Joseph Burns, from the Volume XXV No. 3 – February 12, 2018 issue
“Today, patients want to get diagnosis and treatment faster with fewer visits to the doctor’s office. They want speedier and more comprehensive delivery of clinical services, be it laboratory tests, imaging, or other procedures.”
—Ralph Taylor, President, Sysmex America, Inc.
CEO Summary: To bring testing closer to patients, clinical laboratories will need to offer sophisticated point-of-care systems
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 XXIV, No. 5 – April 3, 2017 issue
CEO SUMMARY: Last Thursday, the federal Centers for Medicare and Medicaid Services said it was extending the deadline for certain labs to report their private payer lab test prices by an additional 60 days, until May 30. Statements by CMS officials indicate that either or both the number of labs that reported and the volume
By Joseph Burns, from the Volume XXIII No. 10 – July 25, 2016 issue
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 company’s founder and CEO Elizabeth Holmes from the operating a clinical laboratory for
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 Robert Michel, from the Volume XXIII, No. 7 - May 23, 2016 issue
CEO SUMMARY: Having ignored the profession of laboratory medicine for nearly all of its 13-year corporate life, Theranos suddenly began engaging with expert laboratorians last month. The timing of this new outreach coincides with public disclosure that CMS proposed the severest sanctions against Theranos, including revocation of the Theranos CLIA certificate. An expanded scientific advisory
By R. Lewis Dark, 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 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 Joseph Burns, from the Volume XXII NO. 15 - October 26, 2015 issue
CEO SUMMARY: Some in the lab industry had high hopes that passage of the Protecting Access to Medicare Act (PAMA) last year would favorably resolve a number of important issues. However, those hopes were dashed following the September 25 release by CMS of a proposed rule setting out how it will collect market test prices
