Text of the letter available here.
Washington, DC - United States Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) today submitted comments to the Accredited Standards Committee X12 (X12) in support of an update to include the unique device identifier (UDI) of medical devices on health insurance claims forms. X12 released a draft claims form including a UDI field earlier this year seeking public comment before finalizing its recommendation. The standards committee could finalize its recommendations as soon as the end of the year.
In a letter to X12's Chairman, Senators Warren and Grassley applauded the decision, noting that this change will not only improve patient health, but will also strengthen the integrity of the Medicare system. "We support X12's decision to include this information on the medical claims form," wrote the Senators. "Poorly performing medical devices can cause serious health risks and cost seniors and people with disabilities millions of dollars in out-of-pocket spending. Faulty devices can result in additional taxpayer dollars to cover the cost of replacing or upgrading such a device."
The Senators previously 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, when they initially 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.