April 20, 2021

In Bipartisan Letter, Senators Warren and Grassley Urge X12 Committee Finalize Its Unique Device Identifiers Recommendation for Medicare Claims Forms

Text of Letter (PDF)

Washington, DC - United States Senator Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) sent a letter to the Accredited Standards Committee (X12), the committee that sets industry standards for commonly used medical forms, urging them to finalize their recommendation that Medicare claims forms include the device identifier portion of a medical device's unique device identifier (UDI), which are serial numbers that are used to identify specific types of medical devices, including implantable devices like pacemakers or artificial joints.

Their letter to X12 follows the senators' November 2019 letters to the Department of Health and Human Services (HHS), the Center for Medicare and Medicaid Services (CMS), and the X12 Committee in support of this recommendation, which the X12 released in October 2019.

"Today, we write for an update on the status of the October 2019 formal recommendation. Specifically, we request information on when X12 plans to publicly release a final new version of the electronic claims transaction and whether that electronic claims transaction will include the device identifier portion of the UDI of high-risk implantable medical devices," wrote the senators

Currently, when a device fails or is recalled, it can be difficult to identify which patients will be affected, leading to risks of complications and increased costs to the health care system. Medical device failures can cause serious health problems and financial costs: a 2017 HHS-Office of Inspector General (OIG) report found that recalls or premature failures of just seven faulty cardiac devices resulted in $1.5 billion in Medicare payments to providers and $140 million in out-of-pocket costs to beneficiaries. 

"Including device identifiers on claims transactions would greatly improve the health system's ability to identify risks and reach patients who may be affected by device failures. Researchers can rely on claims data to track patients' interactions with the health system, even when the patient changes providers. As a result, the data can be used to establish population-level correlations between a particular treatment and a long-term outcome or side effect," the senators wrote

Senators Warren and Grassley have extensively advocated for device identifier information to be collected in both electronic health records and on claims transactions since 2014:

  • Prior to sending letters of support to HHS, CMS, and X12 in November 2019, the senators sent a letter to the Food and Drug Administration (FDA) to reiterate the importance of including medical device identifiers on the updated Medicare claim form and to urge the agency to maintain its support for this change in June 2018.
  • In November 2017, Senators Warren and Grassley pressed CMS to clarify its position on the inclusion of medical devices' device identifiers on Medicare claim forms.
  • In October 2017, both senators issued a statement in support of HHS-OIG's recommendation that the (CMS work to add device identifiers to Medicare claims in order to better track faulty devices.
  • In February 2017, X12 released a draft update to health insurance claims forms that includes device identifiers. The senators commented on the proposal.
  • In August 2016, Senators Warren and Grassley asked X12 about the steps it was taking to include medical devices' UDI on health insurance claim forms, and in October 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 March 2016, Senators Warren and Grassley wrote to HHS, CMS, and FDA inquiring about the progress that had been made in adding the UDI of medical devices to health insurance claim forms. 
  • In December of 2014, Senators Warren and Grassley wrote to CMS expressing support for the inclusion of UDIs in claims forms and pressed CMS to work with other stakeholders on the benefits of a UDI system. In August 2015, the senators wrote another letter to the HHS-OIG requesting 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.