Tag: Rules & Regulations

CMS replaces flash sterilization with IUSS

The Centers for Medicare & Medicaid Services (CMS) has replaced the term “flash sterilization” with “immediate use steam sterilization” (IUSS) in surgical settings. The change in terminology, which applies to Medicare-participating hospitals, critical access hospitals, and ambulatory surgical centers that are subject to Conditions of Participation or Conditions of Coverage,…

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By: OR Manager
December 16, 2014
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Onus on OR managers to scope out competency of endoscopy staff

Recent highly publicized outbreaks of infections linked to improper reprocessing of flexible endoscopes have raised concerns about infection prevention in gastrointestinal endoscopy procedures. Because of the headlines, legislatures are hearing from their constituents that they are fearful of being exposed to infections, and legislatures are getting involved. The Society of…

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By: OR Manager
July 15, 2014
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CMS issues proposed hospital inpatient payment rule

The Centers for Medicare & Medicaid Services (CMS) on April 30 issued its proposed rule that would update FY 2015 Medicare payment polices and rates for inpatient stays at general acute care and long-term care hospitals. The proposed rule will increase the payment rate to general acute care hospitals by…

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By: OR Manager
May 12, 2014
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Anticipate & educate to navigate murky healthcare reform waters

Anxiety over changes in healthcare delivery and payment systems has permeated hospitals and ambulatory surgery centers (ASCs). Administrators are concerned about how the Affordable Care Act (ACA) and other initiatives will hit the organization’s bottom line. Increasingly, perioperative services leaders are being drawn into discussions in these areas. “The OR…

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By: OR Manager
April 16, 2014
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FDA issues Unique Device Identification final rule

The Food and Drug Administration (FDA) on September 24 published the final rule for its Unique Device Identification (UDI) system to provide a consistent way to identify medical devices throughout their distribution and use. “A UDI system for medical devices is an important step towards increasing patient safety, modernizing postmarket…

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By: OR Manager
November 1, 2013
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New quality measures, tight deadline mark CMS payment rule for ASCs

It sounds like déjà vu all over again, as Yogi Berra used to say. That is likely to be the first reaction of many ambulatory surgery center (ASC) administrators to the Calendar Year 2014 Ambulatory Surgical Center Payment Proposed Rule.   Pay formula unchanged Medicare payment updates would continue at…

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By: OR Manager
October 1, 2013
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Medicare may drop bariatric surgery center certification requirement

Supporters of the bariatric surgery facility certification established in 2006 by the Centers for Medicare and Medicaid Services (CMS) are anxiously awaiting the agency’s final ruling on whether to reverse that decision. CMS issued a proposed decision memo in June and is expected to make its final ruling by the…

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By: OR Manager
September 1, 2013
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2013 IPPS rule advances Medicare quality programs

Medicare’s inpatient prospective payment rule for fiscal year 2013 updates payment rates and adds to quality initiatives like value-based purchasing (VBP) and quality reporting. The rule issued August 1, 2012, takes effect October 1, 2012. Here are the highlights.   Payment rates Inpatient payment rates will increase by 2.8% for…

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By: OR Manager
September 1, 2012
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FDA proposes a UDI system for medical devices

The US Food and Drug Administration (FDA) released its long awaited proposed rule for a unique device identification (UDI) system on July 3, 2012. Comments will be accepted for 120 days after the proposed rule is published in the Federal Register, which was expected in early July. The rule would…

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By: OR Manager
August 1, 2012
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Is event-related dating going away?

Because of recent regulatory activity, some are asking whether event-related sterility dating is going away. The answer is no. The confusion is a result of the Food and Drug Administration (FDA) asking Kimberly-Clark (KC) to submit a new 510k application to confirm that its sterilization wrap meets all current requirements.…

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By: Martha Young, MS, CSPDT
May 1, 2010
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