TAG:

proficiency testing

NILA: CLIA Proposal Doesn’t Address Flaws

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 o…

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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…

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Proposed Bill in Congress Would Regulate LDTs

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 …

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Health Insurers Want More Data On Clinical Utility of Molecular, Genetic Tests

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 acc…

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FDA Official Outlines Need for Federal Regulation of LDTs

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 la…

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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.,…

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Washington Post: Theranos Approached Military in 2012

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 …

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WSJ ‘Sticks’ Theranos, Raises Serious Questions

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…

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Medi-Cal to Cut Lab Pay on July 1 by 25% to 30%

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…

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March 30, 2015 Intelligence: Late Breaking Lab News

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 system…

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