Washington, DC –(ENEWSPF)–August 30, 2016. United States Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) sent a letter asking the Accredited Standards Committee X12 (ASC X12) about steps it is taking to include medical devices’ unique device identifier (UDI) on health insurance claim forms. ASC X12 is the body responsible for setting standards for and recommending any changes to the standard electronic claims forms. Including UDI on these forms will help strengthen the post-market tracking of medical devices.
Senators Warren and Grassley wrote, “Collecting device identifiers on insurance claims forms would allow device performance and safety concerns to be tracked and evaluated at the model level, enable the collection and analysis of detailed device and patient data, facilitate outcome comparisons across device models, and protect the integrity of the Medicare program by allowing for faster identification of poorly performing and recalled devices and ensuring that proper reimbursements take place with regard to these devices.”
The senators ask ASC X12 to provide a staff briefing on the actions the committee is taking to finalize the next version of standards associated with electronic claims forms, and its discussions related to the incorporation of UDI information.
In March, Senators Grassley and Warren wrote to HHS Secretary Sylvia Burwell, CMS Acting Administrator Andy Slavitt and FDA Commissioner Robert Califf to inquire about progress that had been made in adding the UDI of medical devices to health insurance claim forms. Last month, in a reply to their letter, Secretary of Health and Human Services (HHS) Secretary Sylvia Matthews Burwell stated that “HHS affirmatively supports adding the device identifier (DI) portion of the UDI for claims for implantable devices.” Additionally, Centers for Medicare and Medicaid Services (CMS) Acting Administrator Andy Slavitt and Food and Drug Administration (FDA) Commissioner Robert Califf recently expressed their support for including UDI on claims forms.
Read a PDF copy of the letter from Warren and Grassley here.