Warren, Grassley Statement on Formal Recommendation from the American National Standards Institute’s Accredited Standards Committee to Include Device Identifier Information on Medicare Claims Forms
Washington, D.C. – U.S. Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) issued the following bipartisan statement following new action by the American National Standards Institute’s Accredited Standards Committee (X12) to include the device identifier (DI) portion of a medical device’s unique device identifier (UDI) on Medicare claims forms:
“Following years of our engagement, the formal recommendation from the American National Standards Institute’s Accredited Standards Committee brings us one step closer to including device identifier information on Medicare claims forms. Adding this information will save lives and federal dollars – improving quality of care for millions of patients that rely on medical devices and enabling more efficient tracking of device outcomes. We hope that the National Committee on Vital and Health Statistics considers this recommendation without delay and includes this proposal in its formal recommendation to the Centers for Medicare and Medicaid Services.”
X12 formally recommended the change to the National Committee on Vital and Health Statistics (NCVHS), a Department of Health and Human Services advisory body. NCVHS must assess the recommendation and officially recommend that the Department adopt such standards. The Centers for Medicare and Medicaid Services (CMS) will then need to add device identifier information to Medicare claims forms through the rulemaking process.
Since 2014, Senators Warren and Grassley have led a bipartisan effort for device identifier information to be collected in both electronic health records and on claims transactions:
- In July 2021, Senators Warren and Grassley, along with Representatives Bill Pascrell (D-N.J.), Brian Fitzpatrick (R-Pa.), and Lloyd Doggett (D-Texas), 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 the Accredited Standards Committee (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.
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