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…
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…
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…
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…
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…
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.…
Implant makers make deal with prosecutors
Four major implant manufacturers made a deal with federal prosecutors to avoid prosecution related to kickbacks to surgeons. In the deal, announced Sept 27 by the US Attorney's office in New Jersey, the companies, including Zimmer, DePuy Orthopaedics, Biomet, and Smith & Nephew, also agreed to pay a total of…
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