- Federal policy chiefs are calling for inclusion of unique device identifiers on insurance claims forms, Modern Healthcare reports.
- In a Wednesday letter, acting CMS Administrator Andy Slavitt and FDA Commissioner Robert Califf asked the Accredited Standards Committee X12 to include UDIs for implantable medical devices on Medicare claims forms.
- The letter follows a Monday JAMA editorial by Califf and FDA device chief Jeffrey Shuren urging more effective tracking of devices from clinical trials through the marketplace.
In their letter, Slavitt and Califf said collecting UDIs in claims would help to identify safety concerns and assess product performance, aid in device surveillance, and support program integrity by making it easier to track rebates from manufacturers back to payers and providers.
Capturing UDI data would also help providers and payers calculate and compare costs and outcomes of implants of specific device models, they add.
Their position reflects that of others who say UDIs could help to flag faulty devices before they harm patients by allowing comparative outcomes analysis.
Devicemakers and distributors are already implementing UDIs on products and packaging, and EHRs are being readied for them, but claims forms have yet to come on board.
“We recognize that collecting the DI is complex and involves providers changing their workflow and billing systems as well as requiring public and private payers, entities that bill providers, clearinghouses, and other entities to change their claims processing systems,” Slavitt and Califf wrote. CMS would also need additional funding to modify a number of legacy computer systems to capture Dis on Medicare claims forms.
They said HHS is committed to working with ASC X12 to make this happen in a way that will minimize disruption for state Medicaid agencies, health plans, small practices and rural hospitals.