WASHINGTON -- Senate Finance Committee members Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) are ramping up momentum behind their decade-long push to include the device identifier (DI) portion of unique device identifiers (UDIs) on Medicare claims forms. This proactive measure would reduce health risks for patients and save taxpayers money in Medicare costs incurred as a result of faulty or recalled devices. 

For years, this issue has been shuffled from agency to agency. In June, the National Committee on Vital and Health Statistics (NCVHS) asked the Food and Drug Administration (FDA) to weigh in. With the finish line seemingly in sight, Grassley and Warren sent the FDA a letter reminding decision makers of their historic support for collecting DI information on claims transactions. In it, the senators urged FDA to expeditiously assess stakeholder comments and patient and provider testimony, as well as positive recommendations by the American National Standards Institute’s accreditation standards committee, X12. 

“The inclusion of DIs on claims transactions would greatly improve our health care system’s ability to identify risks and reach patients who may be affected by device failures, which contribute to serious health problems and impose significant financial costs. In 2017, a [Department of Health and Human Services] Office of Inspector General (OIG) investigation found that recalls or premature failures of just seven faulty cardiac devices resulted in an estimated $1.5 billion in Medicare payments and $140 million in out-of-pocket costs to beneficiaries,” Grassley and Warren wrote. 

“It is therefore critical for the [FDA] to promptly clarify its strong support for the inclusion of DI information in the Medicare claims, a policy that FDA endorsed as recently as last year,” they continued. 

Read the full letter HERE. 

Grassley and Warren’s Engagement to Date:

  • December 2022: Grassley, Warren and Rep. Bill Pascrell (D-N.J.) in a letter to NCVHS applaud X12’s formally recommendation to include DI information on Medicare claims forms.  
  • June 2022: Grassley and Warren led a bipartisan, bicameral group of their colleagues in urging NCVHS to promptly evaluate X12’s recommendation and provide transparency about its review.
  • June 2022: Grassley and Warren 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.
  • July 2021: Grassley, Warren and Pascrell, along with Reps. 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’ UDI in Medicare claims forms.
  • April 2021: Grassley and Warren sent a letter to X12 urging it to finalize its recommendation that Medicare claims forms include the device identifier portion of a medical device's UDI.
  • November 2019: Grassley, Warren, Pascrell and Fitzpatrick, along with Rep, Lloyd Doggett (D-Texas), 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. They wrote HHS, DMS and the X12 Committee.
  • June 2018: Grassley and Warren sent a letter to the FDA to reiterate the importance of including medical device identifiers on the updated Medicare claim form and urge the agency to maintain its support for this change.
  • November 2017: Grassley and Warren pressed CMS to clarify its position on the inclusion of medical devices' DIs on Medicare claim forms.
  • October 2017: Grassley and Warren issued a statement in support of the HHS OIG’s recommendation that CMS work to add device identifiers to Medicare claims, as it would improve tracking of faulty devices.
  • February 2017: X12 released a draft update to health insurance claims forms that includes device identifiers. Grassley and Warren commented on the proposal.
  • 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.
  • August 2016: Grassley and Warren asked X12 about the steps it was taking to include medical devices' UDI on health insurance claim forms.
  • March 2016: Grassley and Warren wrote HHS, CMS and FDA inquiring about progress towards adding the UDI of medical devices to health insurance claim forms.
  • December 2014: Grassley and Warren wrote CMS expressing support for the inclusion of UDIs in claims forms and pressed CMS to work with stakeholders on the benefits of a UDI system.

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