WASHINGTON — Senators Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) issued a bipartisan statement following further action by the American National Standards Institute’s Accredited Standards Committee (X12) to include the device identifier (DI) portion of a unique medical device identifier (UDI) on health insurance application forms:
“After years of commitment, the formal recommendation of the Accredited Standards Committee of the American National Standards Institute brings us one step closer to including device identification information on insurance claim forms. sickness. Adding this information will save lives and federal dollars – improving the quality of care for millions of patients who rely on medical devices and enabling more efficient tracking of device outcomes. We hope that the National Committee on Vital and Health Statistics will consider this recommendation without delay and include 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), an advisory body to the Department of Health and Human Services. The NCVHS should evaluate the recommendation and formally recommend that the Department adopt these standards. The Centers for Medicare and Medicaid Services (CMS) will then need to add device credentials to Medicare claim forms through the rulemaking process.
Since 2014, Grassley and Warren have led a bipartisan effort to have device credentials collected from both electronic health records and claim transactions:
- In July 2021, Grassley and Warren, along with Reps. Bill Pascrell (DN.J.), Brian Fitzpatrick (R-Pa.), and Lloyd Doggett (D-Texas), sent a letter to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure asking them to commit to including medical device UDI in health insurance claim forms.
- In April 2021, Grassley and Warren sent a letter to X12 urging them to finalize their recommendation that health insurance application forms include the device identifier portion of the UDI of a medical device.
- In November 2019, Sens. Grassley and Warren and Representatives Pascrell, Fitzpatrick and Doggett sent letters of support recommendations that the device identifier portion of IDUs be added to the standard information on electronic health insurance claim forms. Their letters were sent to HHS, DMS and the X12 Committee.
- In June 2018, Grassley and Warren sent a letter to the Food and Drug Administration (FDA) to reiterate the importance of including medical device identifiers on the updated Medicare application form and to urge the agency to continue supporting this change in June 2018.
- In November 2017, Grassley and Warren press CMS needs to clarify its position on the inclusion of medical device identifiers on health insurance claim forms.
- In October 2017, Grassley and Warren issued a statement in support of the HHS Office of Inspector General’s (OIG) recommendation that CMS work to add device identifiers to health insurance claims to better track defective devices.
- In February 2017, X12 released a draft update to health insurance claim forms that includes device identifiers. Senators commented on the proposal.
- In August 2016, Grassley and Warren asked X12 on steps it was taking to include medical device UDI on health insurance claim forms, and in October 2016, following preliminary results of the ongoing HHS OIG review, senators again urged CMS and X12 to include device identifiers on health insurance claim forms.
- In March 2016, Grassley and Warren has written to HHS, CMS and the FDA requesting on the progress made in adding the UDI of medical devices to health insurance application forms.
- In December 2014, Grassley and Warren wrote to CMS expressing support for the inclusion of UDIs in claim forms and urging CMS to work with other stakeholders on the benefits of a UDI system.
