Regulations/Legal

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June 2019
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CDC: No significant change in 2018 uninsured rate

Editor's Note The Centers for Disease Control and Prevention (CDC) on May 9 released a National Health Interview Survey that found an estimated 9.4% of US residents (30.4 million people) lacked health insurance in 2018, which is not significantly different than in 2017, but it is 18.2 million fewer than…

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By: Judy Mathias
May 13, 2019
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CDC: Hepatitis A infections up nearly 300%

Editor's Note In the May 10 Morbidity and Mortality Weekly Report, the Centers for Disease Control and Prevention reported that hepatitis A infections were up 294% in 2016-2018, compared with 2013-2015. The increases are related to outbreaks among homeless people, men who have sex with men, people who use drugs,…

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By: Judy Mathias
May 13, 2019
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CMS Physician Compare website lacks physician data

Editor's Note The Centers for Medicare & Medicaid Services (CMS) Physician Compare website contains quality information on just 23.3% of the more than 1 million physicians who care for Medicare patients, this study finds. A total of 76.6% of physician had no performance data, and almost none (99.7%) listed on…

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By: Judy Mathias
May 9, 2019
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FDA issues alert on premature battery depletion in certain Medtronic pacemakers

Editor's Note The Food & Drug Administration (FDA) on May 7 issued a Safety Alert on the risk for premature battery depletion in nearly 132,000 biventricular and conventional cardiac resynchronization therapy implantable pacemakers by Medtronic. The FDA is aware of three patients in which a battery fully drained because of…

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By: Judy Mathias
May 9, 2019
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Joint Commission Ambulatory Care Accreditation team launches new campaign

Editor's Note The Joint Commission on May 8 announced that its Ambulatory Care Accreditation team is launching a "We Know Surgery" campaign to highlight its 45-year history accrediting ambulatory care organizations. The campaign, which is being launched in conjunction with the Ambulatory Surgery Centers Association (ASCA) conference in Nashville May…

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By: Judy Mathias
May 9, 2019
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FDA: Class I recall of Neuro Omega System

Editor's Note The Food and Drug Administration (FDA) on May 6 identified the recall my Alpha Omega Engineering of its Neuro Omega System, including the Drive Headstage unit, as Class I, the most serious. The recall was initiated because a design flaw in the device may connect two separate electrode…

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By: Judy Mathias
May 8, 2019
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Effect of ACA on ED visits, hospital discharges

Editor's Note Though emergency department (ED) visits and hospital discharges by uninsured patients decreased after implementation of the Affordable Care Act, 1 in 10 ED visits and 1 in 20 hospital discharges were still made by uninsured patients from 2014 to 2016, this study finds.   There were 1.4 million…

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By: Judy Mathias
May 6, 2019
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BD receives FDA approval for sterile CHG skin prep solution

Editor's Note Becton, Dickinson and Company (BD) announced on April 30 that it had received Food & Drug Administration (FDA) approval for BD ChloraPrep skin preparation with sterile solution. This new product is the only fully sterile chlorhexidine gluconate (CHG) antiseptic skin preparation commercially available in the US. The FDA’s…

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By: Judy Mathias
May 2, 2019
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HHS lowers maximum penalties for HIPAA violations

Editor's Note The Department of Health and Human Services (HHS) on April 26 announced it is lowering the maximum civil penalty for healthcare providers, health plans, and business associates who violate the Health Insurance Portability and Accountability Act (HIPPA), based on the level of culpability. A 2013 rule created four…

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By: Judy Mathias
May 1, 2019
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FDA: Class I recall of Miller and Fogarty Atrioseptostomy Dilation Catheters

Editor's Note The Food & Drug Administration (FDA) on April 26 identified the recall of Edwards Lifesciences' Miller and Fogarty Atrioseptostomy Dilation Catheters as Class I, the most serious. The recall was initiated because of reports of difficulty in balloon deflation after deployment, which may lead to balloon fragmentation or…

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By: Judy Mathias
April 30, 2019
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