- The Accredited Standards Committee X12, which advises on insurer standards, is recommending device identifiers (DIs) be included on medical claims forms, according to a Pew Charitable Trusts report.
- The move is a "critical first step" toward helping regulators, providers and patients track the long-term safety of cardiac stents, artificial hips, pacemakers, among other medical implants, the report adds.
- The HHS Office of Inspector General (OIG) recently recommended the CMS collabrate with X12 to include DIs in for implants on the next claim forms as they would "assist in identifying the costs to Medicare for recalled or defective medical devices, help ensure patient safety, and safeguard Medicare trust funds."
The OIG reported in October 2016 that Medicare paid $1.5 billion to treat patients implanted with seven faulty cardiac devices. "Our preliminary results show that there is a significant impediment to readily identifying Medicare’s total costs caused by a medical device recall, a device that prematurely failed, or a necessary device upgrade," the OIG stated.
Insurers and patient groups have long pushed for inclusion of DIs on claims forms to help flag dangerous or defective devices before they hurt patients by enabling analysis of comparative outcomes. The Global Unique Device Identifier Database allows hospitals and other to download information about devices by entering the unique device identifier (UDI), though payers are currently left out of the loop.
In a joint letter sent last July, the FDA and the CMS asked X12 to include UDIs for device implants on Medicare claims forms. The committee’s new recommendation moves the needle forward. Former CMS acting Administrator Andy Slavitt reacted to the news on Twitter.
Great news! Glad we got this started. https://t.co/t8QPmxNMha— Andy Slavitt (@ASlavitt) February 1, 2017
“Adding device information to claims is a commonsense approach to improve patient safety and reduce costs,” Ben Moscovitch, manager of health information technology at Pew, told Modern Healthcare. “There’s widespread support across the healthcare system for adding it to claims.”
The draft recommendation is open for public comment for 90 days, after which X12 will finalize it. Once that happens, it will be handed off to other advisory committees for review and then submitted to the HHS and the CMS for sign-off and rulemaking.