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CMS opposition to unique device identification threatens the initiative

By Varun Saxena

The federal agency in charge of running Medicare opposes the integration of unique device identification into insurance claims data, putting it at odds with the FDA and most of the medical community.

The recently departed administrator of the Centers for Medicare & Medicaid Services, Marilyn Tavenner, wrote a letter to two senators in February explaining her concerns about the use of UDI in claims forms due to cost concerns and technical difficulties, The Wall Street Journal reports.

Meanwhile, the FDA has been aggressively implementing the initiative since its implementation in 2013. And Tavenner’s position is also the opposite of that of her former boss, Health and Human Services Secretary Sylvia Mathews Burwell, according to The Wall Street Journal.

“Including UDIs on claims would entail significant technological challenges, costs and risks,” Tavenner wrote. “Mechanisms other than claims reporting for collecting UDIs would avoid the significant challenges and risks” of including UDI data on Medicare bills.

Besides insurance claims forms, UDI data can be disseminated using electronic health records. But they only track events that happened to a patient in the same hospital. If someone has a device implanted while on vacation due to an unexpected heart attack, that information won’t be recorded on the electronic health record at his usual hospital, The Wall Street Journal explains.

By contrast, the insurance company would be billed for the expense regardless of where it occurs, making it a superior method of tracking the information. In addition, the ongoing integration of UDIs into electronic health records suffers from technical challenges of its own, such as a lack of interoperability between different records.

UDI promises to improve patient safety by improving postmarket surveillance and ensuring that faulty medical devices up for recall are actually returned. It could detect problems such as the failure of Medtronic’s ($MDT) Fidelis defibrillator leads which were implanted 268,000 people by the time they were recalled in October 2007. Problems were detected in January of that year, but a lack of a data and data sharing meant that the FDA was slow to react.

The Wall Street Journal cites a study saying the Medtronic defibrillator could cost Medicare anywhere from $287 million to $1.19 billion over 5 years.

In December, senators Elizabeth Warren (D-MA) and Charles Grassley (R-IA) wrote a letter to Tavenner urging CMS to side with various medical associations, think tanks and private insurance companies in support of including UDI information in insurance claims forms.

“Claims transactions provide longitudinal data on patient outcomes across healthcare institutions–a critical capability for implanted medical devices as problems might not emerge for several years and patients may seek care in facilities that did not perform the implant procedure,” the letter explained.

The senators and other stakeholders won’t be happy with Tavenner’s recent response. Med techers should keep a close eye on the position of her future replacement. Former UnitedHealth Group executive Andy Slavitt is the acting administrator.

– here’s the Wall Street Journal article (subscription required)

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