AdvaMed Opposes Adding UDI Info on Claims Forms
Medical device lobbying group AdvaMed continues to oppose adding unique device identifier (UDI) information to insurance claims forms. The opposition follows a recommendation by an advisory committee for Accredited Standards Committee X12 that a UDI device identifier should be a required field on a claims form when a “high-risk implantable device” is implanted or removed.
AdvaMed supports efforts to add UDI information in electronic health records, butit says it is “concerned that a complex dataset that combines UDIs and hospital and physician claims information would be difficult to analyze appropriately and could generate inaccurate and misleading conclusions about the performance and value of specific technologies. This could lead patients and physicians to make ill-informed decisions about the continued use of an important medical device. Further, implementing this requirement represents an unnecessary new regulatory burden on providers. We will be submitting comments to X12 and working with other stakeholders, including CMS and HHS, to share our concerns.”
Both FDA and CMS have called for universal health insurance claims forms to include UDI information. They say the information would help improve post-market surveillance and provide for better value-based reimbursement based on device performance.
Late last year, HHS Office of the Inspector General (OIG) supported capturing UDI information on claims forms to help identify Medicare’s costs related to recalled or failed devices. An OIG Early Alert gave preliminary results from an ongoing review of the costs Medicare incurred due to recalled or defective medical devices. “Our ongoing review shows that the lack of medical device-specific information in the claims data impedes the ability of the Centers for Medicare and Medicaid Services to readily identify and effectively track Medicare’s total costs related to the replacement or recalled or defective devices,” the alert says.
“As described by FDA and CMS,” OIG continued, “including the DI [device information] on claim forms would result in several benefits, which we believe could also help reduce Medicare costs by identifying poorly performing devices, protecting beneficiaries from unnecessary costs, and improving beneficiaries’ chance of receiving appropriate follow-up care more quickly. Including the DI on claim forms could also assist in any related cost-recovery efforts and help prevent fraud and abuse by providing a means to identify unreported manufacturer credits. As the UDI system evolves, we believe that including the production information portion(s) of the UDI on the claim forms could also help identify and track Medicare’s aggregate costs related to recalled or defective devices and would provide patient safety benefits by enabling the identification of specific batches and lots of recalled devices.”