In a policy turn-about, Medicare is recommending that unique device identifiers be included in medical billing records.
Earlier this year, lawmakers had pushed the Centers for Medicare & Medicaid Services to work with the FDA to incorporate unique device identifiers into insurance claims forms, saying it would improve postmarket surveillance and curb waste.
CMS and the FDA now appear to be on the same page with that messaging. In a recent letter to the Accredited Standards Committee X12, CMS Acting Administrator Andrew Slavitt and FDA Commissioner Robert Califf urged the committee to revisit its business requirements to support capturing UDI on claim forms for high-risk devices.
Califf and Slavitt highlighted the benefits of collecting device identifiers for postmarketing safety, which would also “help providers and certain payers to calculate and compare total costs and outcomes based on the device model used,” the letter urged.
The move would also “support program integrity” by providing better information to link the patient and device.
“CMS and FDA are hopeful that ASC X12 can complete its work on the next version of the claims form,” the letter said.
The next version of the form is slated to be revised in December. The duo said they would work to assist the standards committee to develop a consensus-based standard that would capture UDIs.
The FDA is also stressing the importance of incorporating UDI into a national surveillance system for medical devices to gain maximum leverage.
The future national medical device evaluation system — one of CDRH’s 2016-2017 strategic priorities — is intended to capture and use real-world evidence to bolster regulatory decision-making.
In a recent JAMA editorial, which was posted to the CDRH website July 19, Califf and CDRH Director Jeffrey Shuren stressed that clinicians routinely under report adverse events, and that a more strategic approach to linking clinical registries, electronic health records and claims data, could reduce the burdens of obtaining appropriate evidence across the life cycle of a device.
By leveraging clinical data and applying advanced analytics, they said, a more “comprehensive and accurate framework could be created for assessing the risks and benefits of devices.”
Stakeholders have also recommended developing a virtual system for evidence generation by “creating strategic alliances among data sources including registries, EHRs, payer claims, and other sources; incorporating unique device identifiers (UDIs) over time; and activating multiple linkages among data sources to address specific questions,” the editorial said. — Tamra Sami