In a bipartisan push, two lawmakers are pushing for 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.
According to Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.), including UDI in claims would allow for faster identification and recall of poorly performing devices and ensure proper reimbursements for hospitals, device manufacturers and CMS, the senators say in a March 8 letter to HHS Secretary Sylvia Burwell, CMS Acting Administrator Andy Slavitt and FDA Commissioner Robert Califf.
The senators point to a Sept. 1, 2015 letter that they received from HHS Inspector General Daniel Levinson that said recalls of defective products have likely resulted in millions of claims for monitoring services and device replacement-related procedures and services.
Time is of the essence, say Grassley and Warren, adding that the next claims form will be implemented in 2021, but “the window to make changes is rapidly closing.”