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Pascrell, Sen. Warren Lead Call to Improve Medical Device Safety

Adding medical device info to Medicare claims will help millions

U.S. Reps. Bill Pascrell, Jr. (D-NJ-09), Brian Fitzpatrick (R-PA-01), and Lloyd Doggett (D-TX-35), and U.S. Sens. Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) have sent a letter to 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. 

“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,” write 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.”

The 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. On July 6, 2021, the Food and Drug Administration released its Final Guidance on UDI Form and Content, which outlines the requirement that the UDI must be presented in two forms on the device label and device packages: (1) easily readable plain-text; and (2) automatic identification and data capture (AIDC) technology (essentially a barcode). This is another important step towards making sure that all medical devices bear a standardized device identifier.

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.

For years, Rep. Pascrell has led efforts in Congress to improve and modernize medical device safety protocols since 2015. In June 2015, Pascrell called for adding UDI to claims during a markup of H.R. 160, the Protect Medical Innovation Act. In April 2016, Pascrell wrote to then-House Ways and Means Health Subcommittee Chairman Pat Tiberi (R-OH-12) and committee leadership in support of adding UDI to Medicare claims. After Rep. Pascrell held numerous meetings and calls with the Accredited Standards Committee X12, the agency finally recommended in October 2019 that UDIs be included on medical claims. In November 2019, Pascrell and Sens. Warren and Grassley wrote to HHS and CMS highlighting the X12’s recommendation and urging them to promulgate regulations to implement the change. In February 2020, Pascrell grilled then-HHS Sec. Alex Azar to finalize the recommendation to include device identifiers on claims data which was in the Trump budget request. And In June 2021, Pascrell pressed Sec. Becerra during a hearing if he would commit to finalizing the UDI in claims language.

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