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. 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. 7 – May 15, 2017 issue
CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both laboratory-developed tests and in vitro diagnostic test kits, changing current regulatory protocols for
By Joseph Burns, from the Volume XXIV, No. 4 – March 13, 2017 issue
CEO SUMMARY: Genetic tests that lack two essentials are troublesome for the nation’s health insurers. Those essentials are clinical validity and clinical utility. During a recent webinar, two executives from major health insurers stressed the need for genetic testing labs to provide acceptable evidence that their genetic test is accurate and that it produces information
By Robert Michel, from the Volume XXIII No. 14 – October 17, 2016 issue
AT A CONGRESSIONAL BRIEFING LAST WEEK, a federal official charged with regulating laboratory-developed tests made the case that LDTs are inconsistently reliable and thus put patients at risk, according to MedPage Today.
“If you take the same patient sample and you send it to different labs, you can get different results,” stated Jeff Shuren, MD. He is
By R. Lewis Dark, from the Volume XXIII, No. 8 – June 13, 2016 issue
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., and force the lab to close? Or will it soften its
By Joseph Burns, from the Volume XXII NO. 17 - December 7, 2015 issue
SINCE THE WALL STREET JOURNAL published its exposé of Theranos Inc. in October, other media outlets have published the findings of their own investigations into various aspects of the lab company’s practices.
One example is the disclosure by The Wall Street Journal in November that Theranos had an agreement with Safeway to put blood collection and
By Robert Michel, from the Volume XXII NO. 15 - October 26, 2015 issue
CEO SUMMARY: Following months of investigation, reporter John Carreyrou of The Wall Street Journal published back-to-back reports about aspects of Theranos that the secretive company has kept from public view. Based on interviews with several employees and others with knowledge of events at Theranos, the WSJ disclosed that Theranos runs only a handful of tests
By Joseph Burns, from the Volume XXII NO. 9 - June 22, 2015 issue
CEO SUMMARY: Since 2011, state officials in California have aggressively cut laboratory testing fees for Medi-Cal, the state’s Medicaid program. Now state officials say they will implement a new methodology next month for determining lab testing fees. The new methodology is based on lab pricing data produced as a result of whistleblower lawsuits against labs that were settled in 2011. Should prices fall below the costs of performing these tests, the Medi-Cal program may see legal challenges from the lab industry.
By Robert Michel, from the Volume XXII NO. 5 - March 30, 2015 issue
Last Friday, at Geisinger Medical Center in Danville, Pennsylvania, members of the health systems’s authority board were given tours of the new $63.4 million clinical laboratory facility. It is scheduled to open on May 4 and will feature the latest state-of-the art analyzers and lab automation systems. Located in a new building of 162,378 square feet, it will be home to more than 350 lab employees.
