Regulations/Legal

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December 2017
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Value of voluntary bundled-payment program unclear

Editor's Note For the third year in a row, researchers with the Lewin Group couldn’t determine whether Medicare’s voluntary Bundled Payment for Care Improvement initiative cuts costs and improves care, the October 31 Modern Healthcare reports. The Centers for Medicare & Medicaid Services (CMS) funded analysis found that although providers…

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By: Judy Mathias
November 1, 2017
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CMS issues guidance on MIPS information blocking component

Editor's Note The Centers for Medicare & Medicaid Services (CMS) has issued new guidance designed to offer clarity on the Merit-based Incentive Payment System’s (MIPS) data blocking component, the October 30 Healthcare Informatics reports. The guidance outlines how MIPS-eligible clinicians can show they are fulfilling the information blocking requirement, which…

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By: Judy Mathias
November 1, 2017
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FDA: Increased rate of major adverse events with Absorb GT1 Bioresorbable Vascular Scaffold

Editor's Note The Food and Drug Administration (FDA) on October 31 issued a Safety Alert saying that interim study results continue to show an increased rate of major adverse cardiac events and Bioresorbable Vascular Scaffold (BVS) thrombosis in patients receiving the Absorb GT1 BVS by Abbott Vascular (Abbott Park, Illinois),…

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By: Judy Mathias
October 31, 2017
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Manufacturers optimistic about repeal of medical device tax

Editor's Note On October 24, 179 House members (including 43 Democrats) signed a letter to Speaker Paul Ryan (R-Wis) calling for repeal of the medical device tax, the October 25 issue of The Hill reports. The medical device tax, which was included in the Affordable Care Act to help pay…

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By: Judy Mathias
October 27, 2017
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Joint Commission: New Sentinel Event Alert video on RSIs

Editor's Note The Joint Commission on October 25 announced a new Sentinel Event Alert video on Preventing Unintended Retained Foreign Objects, also known as retained surgical items (RSIs). The new video with Erin Lawler, a human factors engineer from the Joint Commission, explains how to maximize safety in the OR…

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By: Judy Mathias
October 25, 2017
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FDA: SCA pharmaceuticals recalls certain lots of injectable products

Editor's Note The Food and Drug Administration (FDA) on October 21 announced the recall by SCA Pharmaceuticals (Little Rock, Arkansas) of various lots of injectable products.  The recall was initiated because of the potential for the products to contain microbial contamination.  Many of the recalled products are used in anesthesia,…

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By: Judy Mathias
October 24, 2017
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FDA updates Safety Alert for St Jude defibrillators

Editor's Note The Food and Drug Administration (FDA) on October 19 issued an updated Safety Alert for implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators by St Jude Medical. Because batteries for the devices may fail earlier than expected, St Jude has made available a new battery performance management tool,…

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By: Judy Mathias
October 23, 2017
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FDA clears new surgical robot

  Editor's Note The Food and Drug Administration (FDA) on October 13 cleared the Senhance System (TransEnterix Surgical Inc, Morrisville, North Carolina), a new robotically-assisted surgical device. The design of the Senhance System allows surgeons to sit at a console unit that provides a 3-D high-definition view of the surgical…

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By: Judy Mathias
October 18, 2017
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Joint Commission abandons proposed telehealth standards

Editor's Note The Joint Commission has abandoned proposed amendments to its accreditation standards that would have required healthcare systems to obtain patient consent, confirm patient location, and predict a patient’s financial responsibility before providing telehealth services, the October 11 mHealth Intelligence reports. The changes, which would have amended two existing…

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By: Judy Mathias
October 16, 2017
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Comparison of internal medicine, general surgery residents’ postop risk assessments

Editor's Note Risk assessments of postoperative complications and death in surgically complex patients were not significantly different between internal medicine and general surgery residents in this study. However, both groups overestimated the risks compared with the American College of Surgeons’ National Surgical Quality Improvement Project (ACS NSQIP) risk adjusted model.…

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By: Judy Mathias
October 12, 2017
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