Sen. Warren: Bipartisan Group of Lawmakers Urge HHS and CMS to Include Unique Device Identifiers in Medicare Claims Forms

WASHINGTON, July 23 -- Sen. Elizabeth Warren, D-Massachusetts, issued the following news release:

United States Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa), and Representatives Bill Pascrell (D-N.J.), Brian Fitzpatrick (R-Pa.), and Lloyd Doggett (D-Texas) sent a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra and Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure requesting that they commit to including medical devices' unique device identifier (UDI) in Medicare claims forms. Doing so would improve quality of care for millions of patients that rely on medical devices and enable more efficient tracking of medical device outcomes, saving lives and money.

Their letter follows Secretary Becerra's recent comments to Congress on the importance of tracking device outcomes in Medicare claims, as well as President Biden's support for UDIs in his FY2022 budget.

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.

UDIs are the serial numbers used to identify specific types of medical devices, including implantable devices like pacemakers or artificial joints. For UDIs to be included in Medicare claims, X12, which sets standards for claims transactions, must first submit a formal recommendation to the National Committee on Health and Vital Statistics (NCHVS)--an HHS advisory body--urging CMS to do so. NCHVS must then, after assessing the recommendation, officially recommend to CMS that they include UDIs in claims. Finally, CMS must add UDIs to Medicare claims through the rulemaking process. In April 2021, Senators Warren and Grassley urged the X12 Committee to finalize its UDIs recommendation for Medicare claims forms. In May 2021, X12 responded and confirmed its commitment to including UDIs in its formal recommendation to the federal government

"We believe that HHS and CMS should expeditiously take steps to add the device identifier portion of UDIs in Medicare claims, and we ask you to commit to finalizing this change as soon as possible," wrote the lawmakers. "We look forward to working with you and your staff on a bipartisan basis to ensure that the device identifier portions of UDIs are included in Medicare claims forms."

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:

* In April 2021, Senators Warren and Grassley urged the X12 Committee to finalize its UDIs recommendation for Medicare claims forms.

* Prior to sending letters of support to HHS, CMS, and X12 in November 2019, the Senators and Members of Congress 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 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.