Regulations/Legal

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March 2019
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Reliability of measuring surgeon spending for MIPS

Editor's Note The Centers for Medicare & Medicaid Services should measure surgeon spending at a group level or incorporate multiple years of data to reduce misclassification of surgeon performance in its Merit-based Incentive Payment System (MIPS) program, this study finds. University of Michigan researchers found that annual cost-profiles of individual…

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By: Judy Mathias
November 27, 2018
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FDA plans big changes to 510(k) pathway

Editor's Note The Food and Drug Administration (FDA) on November 26 announced that it plans to modernize its 510(k) approval pathway by pushing device manufacturers to rely on predicate devices that are not older than 10 years. Under the existing pathway, manufacturers can pursue expedited approval for devices that are…

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By: Judy Mathias
November 27, 2018
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FDA: Fresenius Kabi recalls sodium chloride injection

Editor's Note The Food and Drug Administration (FDA) on November 20 announced the nationwide recall by Fresenius Kabi USA (Lake Zurich, Illinois) of 163 lots of sodium chloride injection, USP, 0.9%, 10 mL and 20 mL vials. The recall was initiated because the product insert incorrectly states that the vial…

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By: Judy Mathias
November 26, 2018
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Research backs changes to AORN's Guideline for Sterilization

AORN’s updated Guideline for Sterilization is based on a recent review of evidence in peer-reviewed journals and regulations from 2012 to 2017. In addition to guidance for sterilizing reusable medical devices to be used in perioperative and procedural settings, the updated guideline points to findings that substantiate current practices, and…

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By: Susan Klacik, BS, CRCST, CHL, CIS, ACE, FCS
November 14, 2018
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93% of eligible clinicians received MIPS payment under QPP last year

Editor's Note New data from the Centers for Medicare & Medicaid Services (CMS) shows that 93% of eligible clinicians who participated in the Merit-Based Incentive Payment System (MIPS) under the Quality Payment Program (QPP) received positive payment adjustments for their performance last year, the November 9 EHR Intelligence reports. Only…

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By: Judy Mathias
November 13, 2018
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US smoking rates at record low

Editor's Note Cigarette smoking rates in the US have dropped to the lowest level ever recorded, according to the November 9 Morbidity and Mortality Weekly Report. The smoking rate for adult smokers fell from 15.5% in 2016 to 14% in 2017, a rate 67% lower than it was in 1965.…

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By: Judy Mathias
November 13, 2018
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FDA launches app for EHR data collection

Editor's Note The Food & Drug Administration (FDA) recently launched a new app to help streamline electronic health record (EHR) data collection for researchers, The November 7 EHR Intelligence reports. Using the MyStudies app, researchers can access patient-generated health data, EHR patient data, and claims and billing information for use in…

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By: Judy Mathias
November 13, 2018
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Success in efforts to prevent HAPUs may depend on data sources

Editor's Note Transitioning from administrative data to chart-based surveillance review to measure hospital-acquired pressure ulcers (HAPUs) and accounting for HAPU severity could improve the validity of measures for assessing the clinical and financial impact of value-based purchasing interventions, this study finds. Assessing HAPU incidence, severity, and trends using administrative data…

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By: Judy Mathias
November 8, 2018
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Joint Commission announces new requirement for THKR certification

Editor's Note The Joint Commission on November 7 announced a new requirement of participation in a national joint replacement registry for its advanced Total Hip and Total Knee Replacement (THKR) certification, effective July 1, 2019. The Disease Specific Care Performance Measurement (DSPM) standard DSPM.4, element of performance (EP) 2 will…

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By: Judy Mathias
November 8, 2018
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DVN GL announces first US sterile processing certification

Editor's Note Healthcare accreditation organization DNV GL Healthcare on November 7 launched the first sterile processing program certification in the US. The program recognizes excellence in an organization’s sterile processing department within the scope of infection prevention and control, surgical services, endoscopic services, and related departments. An important part of…

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By: Judy Mathias
November 8, 2018
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