The heads of the CMS (Centers for Medicare & Medicaid Services) and the Food and Drug Administration want universal health insurance claims forms to include unique device identifiers. The UDI would improve post-market surveillance and provide for better value-based reimbursement based on device performance, they say.
CMS Administrator Andy Slavitt and FDA Commissioner Dr. Robert Califf wrote to the chair of the Accredited Standards Committee X12, or ASC X12, to ask that the organization add UDIs for implantable medical devices on claims forms. The letter reflects the FDA’s push to improve device evaluation and surveillance, as outlined in a JAMA editorial Monday co-written by Califf.
Proponents of the use of UDIs say they could more quickly identify dangerous devices, some of which in recent years have not been flagged until they hurt patients. Those pushing for the use in claims say they could inform population health by evaluating associated outcome data.
Manufacturers and distributors currently are implementing UDIs and electronic health records are being tweaked to allow providers to one day record unique device identifiers, but insurance claims forms had been the holdout. Some in the industry say the changes are costly because the technology to support the changes isn’t there.
ASC X12 will release the next version of the insurance claims form for public comment in December. That template will be released in 2021. The next update isn’t scheduled for another 10 years.