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…
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…
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.…
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…