February 02, 2017

Senators Warren and Grassley Respond to Announcement of Inclusion of Medical Device UDI on Health Insurance Claims Forms

Washington, DC - United States Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) today responded to yesterday's announcement by the Accredited Standards Committee X12 (X12) that a draft update to health insurance claims forms includes medical devices' unique device identifier (UDI). The Senators wrote to X12 chair Gary Beatty in August to urge this step and have pressed for inclusion of device information on claims forms since 2014.

"Adding device identifier information to insurance claims forms will make a dramatic difference in our ability to track down faulty medical devices before they can hurt people," said Senator Warren. "Simply adding one line to this form, as the standards committee has recommended, takes a huge leap toward improving patient safety, and it also helps control health costs. I appreciate the hard work that X12 has put into this draft form, and I look forward to seeing their recommendation implemented as the claims form revision process moves forward."

"Patients deserve to have high quality medical devices for their safety and quality of care," said Senator Grassley. "Medicare needs to be able to better track the products to ensure which ones should be recalled or replaced. The inspector general has documented problems with recalls of defective products for both patients and taxpayers. There's widespread support for adding unique device identifiers to Medicare claims forms. The recommendation from the standards committee is a major step in the right direction for patients and taxpayers."

In December of 2014, Senators Grassley and Warren wrote to Centers for Medicare and Medicaid Services (CMS) Administrator Marilyn Tavenner to express support for the inclusion of UDI in claims forms and press CMS to work with other stakeholders to realize the benefits of a UDI system. In August 2015, the Senators wrote another letter to the Department of Health and Human Services (HHS) Inspector General Daniel Levinson, asking him to provide information about his review of the cost to Medicare incurred by defective medical devices and the challenges of obtaining this data absent a way to track medical devices through claims forms.

In March of 2016, Senators Grassley and Warren wrote to HHS Secretary Sylvia Burwell, CMS Acting Administrator Andy Slavitt and Food and Drug Administration (FDA) Commissioner Robert Califf to inquire about progress that had been made in adding the UDI of medical devices to health insurance claim forms. In a July, 2016 response to their letter, Secretary Burwell stated that "HHS affirmatively supports adding the device identifier (DI) portion of the UDI for claims for implantable devices." In addition, Administrator Slavitt and FDA Commissioner Califf expressed their support for including UDI on claims forms.

In August of 2016, Senators Warren and Grassley wrote another letter asking the X12 about steps it was taking to include medical devices' UDI on health insurance claim forms. And in October of 2016, following the preliminary results of the HHS OIG ongoing review, the Senators again urged CMS and X12 to include UDIs on health insurance claim forms.