The practice of adding unique device identifiers to Medicare claims forms now has the backing of both the FDA and CMS, despite previous pushback on the practice from the latter.
CMS’ Andy Slavitt and the FDA’s Robert M. Califf, in a letter sent this week, asked that the standards committee revisit the business requirements for supporting UDI data on claims forms. They said they hope the committee can include the new standards for the next version of the form, set to be released Dec. 1.
This is a marked change from the Centers for Medicare & Medicaid Services' previous stance. The agency had pushed back against adding UDIs to claims forms because of technical hurdles and high costs involved in overhauling the form. In fact, just last spring former Medicare Administrator Marilyn Tavenner said putting the UDI into electronic health records or device registries kept by companies should be sufficient to promote safety.
Now Slavitt is taking the opposite stance, touting the need for new standards in a tweet sent Thursday night, saying there's still lots of work ahead.
We should have device identifiers on claim forms. Today FDA Comm. Califf & I sent a letter to this effect. Lots of collab. & steps ahead.— Andy Slavitt (@ASlavitt) July 14, 2016
Slavitt and Califf added in their letter that UDIs on claims forms will be beneficial for providers and payers in helping them “calculate and compare total costs and outcomes based on the device model used,” as well as aiding in the collection of patient data on devices and for innovation of the tools.
Robert G. Hauser, M.D., emeritus consulting cardiologist at the Minneapolis Heart Institute, praised the news in an interview with the Wall Street Journal.
“It’s going to facilitate getting recalled products off the shelves of hospitals,” he said.
Hauser added that it will help providers better keep an eye on devices to know when they were implanted and better estimate failure and manufacturer rates.