October 06, 2017

Warren and Grassley Issue Bipartisan Statement on HHS Inspector General Report About Medical Device Identifiers

Senators Encouraged by Recommendation That Device Identifiers Be Used to Strengthen Safety, Reduce Costs

Washington, DC - In a report earlier this week, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) recommended that the Centers for Medicare & Medicaid Services (CMS) work to add device identifiers (DIs) to Medicare claims in order to better track faulty devices. Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) issued a joint statement in response today.

"We are pleased to see that the Office of Inspector General has recommended that CMS work to ensure that device identifiers are included on the next version of the Medicare claims form," said Senators Grassley and Warren. "We have repeatedly urged CMS and the Accredited Standards Committee X12 to take this step. As the OIG's analysis shows, poorly performing medical devices can cost taxpayers billions of additional dollars to cover the cost of replacing faulty devices and leave seniors and people with disabilities on the hook for extra out-of-pocket costs."

Senators Warren and Grassley have been pressing for inclusion of device information on claims forms since 2014.

In December of 2014, Senators Grassley and Warren wrote to CMS Administrator Marilyn Tavenner to express support for the inclusion of unique device identifiers (UDIs) 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 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 device identifiers on claims forms.

In August of 2016, Senators Warren and Grassley wrote another letter asking the Accredited Standards Committee X12 (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 device identifiers on health insurance claim forms.

In February of 2017, X12 released a draft update to health insurance claims forms that includes device identifiers. The senators commented on the proposal.