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, according to the letter.
“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 healthcare 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 U.S. FDA 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 technology (essentially a barcode). This is another important step toward 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.