Standards/Regulations

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February 2018
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FDA: Bella Pharmaceuticals recalls all sterile drug products

Editor's Note The Food and Drug Administration on August 18 announced the recall by Bella Pharmaceuticals (Chicago, Illinois) of all lots of unexpired sterile drug products because of a lack of sterility assurance. Affected products include all lots distributed April 17, 2017, to August 10, 2017, nationwide. Products are packaged in…

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By: Judy Mathias
August 21, 2017
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Few outcome measures meet criteria for accuracy, validity assessment

Editor's Note This study from the Joint Commission finds that criteria for assessing whether outcome measures are accurate and valid enough to use for public reporting, payment, and accreditation are not well-defined. The authors propose four criteria to assess outcome measures: Strong evidence should exist that good medical care leads…

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By: Judy Mathias
August 17, 2017
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FDA: Class I recall of Zenith Alpha Thoracic Endovascular Graft by Cook Medical

Editor's Note The Food and Drug Administration (FDA) on August 16 classified the recall by Cook Medical Inc (Bloomington, Indiana) of its Zenith Alpha Thoracic Endovascular Graft as Class I, the most serious. Cook Medical is aware of reported cases where the graft became blocked or closed with blood clots…

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By: Judy Mathias
August 17, 2017
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Joint Commission: Quick Safety on noises, distractions in ORs

Editor's Note The Joint Commission on August 16 announced a new Quick Safety that focuses on noise and distractions in the OR and how they can make it difficult to hear and discern information or communicate effectively. ORs are prone to high levels of noise, which can be distracting and…

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By: Judy Mathias
August 17, 2017
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CMS proposes canceling two bundled payment models, scaling back a third

Editor's Note The Centers for Medicare & Medicaid Services (CMS) on August 15 announced a proposed rule that would cancel two bundled-payment models and reduce the number of providers required to participate in a third. The proposed rule would cancel the Episode Payment Models and the Cardiac Rehabilitation incentive payment…

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By: Judy Mathias
August 16, 2017
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Survey: Half of practices spend $40K per physician to comply with federal regs

Editor's Note A new Medical Group Management Association survey of 750 physician group practices finds that nearly half spend more than $40,000 per physician each year to comply with federal regulations, the August 10 FierceHealthcare reports. Respondents say the most burdensome regulation is Medicare’s new Merit-Based Incentive Payment System (MIPS)…

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By: Judy Mathias
August 16, 2017
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FDA: Safety Alert on liquid-filled intragastric balloon systems

Editor's Note The Food and Drug Administration (FDA) on August 10 issued a Safety Alert to update healthcare providers on five reports of unanticipated deaths that have occurred from 2016 to the present in patients with liquid-filled intragastric balloon systems used to treat obesity. Four reports involve the Orbera Intragastric…

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By: Judy Mathias
August 14, 2017
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Purpose of CMS readmission program questioned

Editor's Note The Centers for Medicare & Medicaid Services (CMS) Hospital Readmissions Reduction Program has only seen a drop in readmissions by 0.1% from 2013 to mid-2016, which has industry experts and hospital leaders questioning its purpose, the August 12 Modern Healthcare reports. The Affordable Care Act mandated program, which…

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By: Judy Mathias
August 14, 2017
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Hospitals partnering with ASCs to perform outpatient total joints

Editor's Note With the growth of ambulatory surgeries and the shift to Medicare reimbursement for outpatient hip and knee replacements, hospitals are acquiring and forming joint ventures with ambulatory surgery centers (ASCs), the August 5 Modern Healthcare reports. This allows hospitals to keep part of the revenue and better aligns…

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By: Judy Mathias
August 10, 2017
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Medicare ‘meaningful use’ data to be submitted via QualityNet

Editor's Note The Centers for Medicare & Medicaid Services (CMS) announced August 7 that hospitals and critical access hospitals participating in  Medicare’s Electronic Health Record (EHR) Incentive Program will submit their “meaningful use” data via QualityNet rather than the EHR Incentive Program Registration and Attestation System beginning January 2, 2018,…

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By: Judy Mathias
August 9, 2017
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