The Centers for Medicare & Medicaid Services is on board with plans to create a unique device identifier for implantable medical devices, after years of resistance from the federal health insurer.
CMS had balked at implementing the FDA’s UDI program because of the cost and difficulty of integrating UDIs into electronic health records. Congress enacted the UDI law in 2007, intending to have the FDA use billing claims data with the UDI number to track medical device safety. Medtech companies began incorporating UDIs into their labeling in 2014. But CMS opposed the UDI plan, saying the project is too large and expensive to implement.
In a July 13 letter to the Accredited Standards Committee X12, acting CMS administrator Andrew Slavitt and FDA commissioner Dr. Robert Califf said that the Health & Human Services Dept. supports adding UDIs to Medicare claims for implantable medical devices “if sufficient funding and resources are provided to make the necessary Medicare claims processing system changes.”
“There are several benefits to collecting the DI on claims forms for implantable devices. Collecting the DI would: Allow for the evaluation of product performance and identification of safety concerns for devices at the model level; facilitate the collection and analysis of patient data for devices at the model level that would be helpful in surveillance efforts and device innovations; help providers and certain payers to calculate and compare total costs and outcomes based on the device model used; and support program integrity by providing better information to link the patient and implanted device to help track rebates from manufacturers back to the payer or provider,” they wrote.