An insurer standards committee is moving the process forward for including unique device identifiers on insurance claims forms.
Since the start of the UDI system, providers, payers and patient advocates have called for the trackable IDs to be included on claims forms to help the industry more quickly identify dangerous devices and better evaluate outcome data. An advisory committee for Accredited Standards Committee X12, or ASC X12, made its recommendation this week that a device identifier should be a required field on a claims form when a “high-risk implantable device” is implanted or removed.
The recommendation says that the UDI should be included when the provider and payer have mutually agreed or are mandated by law to exchange the information when a device is implanted, or when it's removed due to concerns that it may fail. X12 didn't refer to a specific device risk class as defined by the Food and Drug Administration, but Class III devices are the highest-risk products as defined by the FDA.
Devices that should be included in claims forms include cardiac stents, artificial hips, pacemakers and implantable defibrillators, all of which can pose great harm to a patient if they malfunction, said Ben Moscovitch, manager of health information technology for the Pew Charitable Trusts. Pew is advocating for the inclusion of UDIs on claims forms.
“Adding device information to claims is a commonsense approach to improve patient safety and reduce costs,” Moscovitch said. “There's widespread support across the healthcare system for adding it to claims.”
The Obama-appointed former chiefs of the FDA and the CMS sent a letter to ASC X12's chair last year advocating for including UDIs on the standard claims form that is used by public and private payers alike. EHRs are currently being tweaked to allow providers to record device identifiers in patient records.
There are still many steps to go before UDIs can be implemented in claims forms. X12 must finalize this and other recommendations for claims forms, which must be reviewed by advisory committees and then presented to the CMS to develop the final rule. All of this takes several years, and there's a limited time frame for implementation.
If UDIs doesn't make it on the form this cycle, it may have to wait another decade. The template for the next version of the claims form is expected to be released in 2021, and it could be 10 more years after that before another version is released.