Standards organization approves UDI changes

As urged by the AHA, X12 voted last night on a solution for reporting the new unique device identifier on health care claims that will allow tracking of medical devices for safety reasons, while minimizing disruptions to automated claims processing. The technical solution meets the objectives that the Food and Drug Administration and Centers for Medicare & Medicaid Services laid out in a July 13 letter to X12, the national standards body for the development and maintenance of electronic data interchange standards. The solution also meets the operational concerns that AHA shared with FDA and CMS in its Sept. 12 letter. “We are pleased that stakeholders have found a solution that will work for patients and providers,” said AHA Executive Vice President Tom Nickels. “The AHA has long supported the UDI as important for patient safety. We are glad the FDA will develop a list of specific high-risk implantable devices that are recommended for reporting the UDI on the claim. While there are still details to be worked out, this development should lead to a workable solution.”