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clia 88
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.,…
National Lab Standards Coming For Patient Safety
CEO SUMMARY: Because lab test data plays such an important role in medical decision-making, the Centers for Disease Control and Prevention (CDC) has launched a national effort to evaluate the quality of clinical and public health laboratories. In forming a Quality Institute, the goal is t…
CURRENT ISSUE
Volume XXVII, No. 18 – December 28, 2020
There are several surprises in The Dark Report’s annual list of the Top 10 Lab Stories for 2020. Despite the SARS-CoV-2 pandemic dominating every aspect of clinical care, social life, and economic activities since March, at least one major health insurer pushed ahead with two major policies governing how labs can submit claims. In another big story, for the first time in decades, the federal Anti-Kickback Statute and the Stark Law were revised with new final rules. Also, Medicare lab test spending increased in 2019 despite PAMA cuts.
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