CMS Acting Administrator Andy Slavitt said this week the agency is working with the Food and Drug Administration to possibly add unique identifiers for medical devices to insurance claims forms. He said the idea “has merit, particularly from a research perspective.”
Slavitt was testifying in front of the House Ways and Means Subcommittee on Health about the Medicare Access and CHIP Reauthorization Act when Rep. Bill Pascrell (D-N.J.) asked him about adding the idea.
The CMS has previously said it would cost too much and the technology required would be too complicated. Slavitt said it would require funding and training but did not indicate those would present insurmountable problems.
Pascrell said it is important to be able to track the devices and evaluate their performance.
“We're talking about the safety of the people who use these devices and we all want to be on the same page,” he said, adding that he had heard stories that many patients, including seniors have faced issues. "And we need to address that in order to improve safety.”
About 50,000 serious adverse events related to medical devices are reported to the FDA each year, including about 3,000 deaths.
Marking medical devices and their labels with an electronically readable UDI could help reduce medical errors, improve product registries and make recalls much more effective.
The FDA began requiring unique device identification in 2007, but there is no spot to include it on current claims forms. The CMS Office of Inspector General said earlier this year that identifiers should be in claims forms to improve follow-up care and help the CMS make better coverage and reimbursement decisions.
Dr. Joseph Drozda, director of outcomes research at Mercy Health System, said the forms are evaluated and updated about every 10 years and the accrediting committee will meet soon to consider changes.
He said he was glad to hear Slavitt's endorsement.
“I'm feeling as if we've sort of gotten a breakthrough,” he said.
The data can be used to improve comparative effectiveness research, evaluate performance and identify safety concerns, according to The Pew Charitable Trusts.