Warren, Grassley, Pascrell, Doggett, Fitzpatrick Lead Bipartisan Call on National Committee on Vital and Health Statistics to Support Inclusion of Device Identifier Information on Medicare Claims Forms
NCVHS Should Recommend Including the Device Identifier Portion of a Medical Device’s Unique Device Identifier to HHS
Washington, D.C. – U.S. Senators Elizabeth Warren (D-Mass) and Chuck Grassley (R-Iowa) and U.S. Representatives Bill Pascrell (D-N.J.), Lloyd Doggett (D-Texas), and Brian Fitzpatrick (R-Pa.) sent a letter to the National Committee on Vital and Health Statistics (NCVHS), calling on the committee to support the inclusion of device identifier (DI) information on Medicare claims forms in its recommendations to the Department of Health and Human Services (HHS) for the next version of standard transactions.
“The inclusion of 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,” wrote the lawmakers. “We have extensively advocated for DI information to be collected in both electronic health records and on claims transactions to help reduce health risks and costs to the Medicare system.”
Their letter follows the American National Standards Institute’s Accredited Standards Committee’s (X12) June 2022 formal recommendation to NCVHS to include the DI portion of a medical device’s unique device identifier on Medicare claims forms. In its recommendation to NCVHS, X12 stressed that “(i)ncluding device identifier information on claims transactions greatly improves the industry's ability to identify risks and reach patients who may be affected by device failures,” “improves patient outcomes and reduces patient health risks and enhances tracking and reporting related to specific devices,” and “also (saves) taxpayer funds.”
Since 2014, Senator Warren has led a bipartisan effort for device identifier information to be collected in both electronic health records and on claims transactions:
- In June 2022, Senators Warren and Grassley issued a statement following new action by the X12 to include the DI portion of a medical device’s unique device identifier on Medicare claims forms.
- In July 2021, Senators Warren and Grassley and Representatives Pascrell, Fitzpatrick, and Doggett sent a letter to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure requesting that they commit to including medical devices’ unique device identifier in Medicare claims forms
- In April 2021, Senators Warren and Grassley sent a letter to X12 urging them to finalize their recommendation that Medicare claims forms include the device identifier portion of a medical device's Unique Device Identifier
- In November 2019, Senators Warren and Grassley and Representatives Pascrell, Fitzpatrick, and Doggett sent letters in support of recommendations that the device identifier portion of UDIs be added to the standard information on electronic health insurance claims forms. Their letters were sent to the HHS, DMS and the X12 Committee
- In June 2018, Senators Warren and Grassley 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, Senators Warren and Grassley 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 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.
Next Article Previous Article