Upon their introduction in 2007, unique device identifiers were to be included with claims form data to monitor medical device safety. However, CMS has recently exerted pushback to including UDIs on claims forms, saying it introduces technical obstacles and excessive costs, according to a Wall Street Journal report.
According to the report, former CMS Administrator Marilyn Tavenner wrote a letter to two senators saying "including UDIs on claims would entail significant technical challenges, costs and risks" and "mechanisms other than claims reporting for collecting UDIs would avoid the significant challenges and risks."
Ms. Tavenner's letter did say inclusion of UDIs in EMRs or device registries could achieve the same goal, promoting safety of devices, but safety experts say insurance databases are more accessible and more often cross state lines, proving to be the superior host of the UDIs, according to the report.
Proponents of incorporating UDIs into claims data suggest it will help reduce costs by identifying malfunctioning devices and stopping their usage sooner. Additionally, Phillip Lerner, medical director of Aetna, said in the report that it is important for Medicare to start including UDIs because private payers typically follow Medicare's format for bills.
However, CMS remains adamant against including the data, according to the report. In an email from CMS to the Accredited Standards Committee X12 — a public-private entity determining standards of electronic medical bills — staffers wrote that Medicare "does not support any scenario wherein the UDI is integrated into a claim transaction, stored in claims history or utilized anywhere in the claims adjudication and payment process," according to the report.
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