Washington, DC – United States Senator Elizabeth Warren (D-Mass.), member of the Senate Committee on Health, Education, Labor, and Pensions, and Senator Chuck Grassley (R-Iowa), Chairman of the Senate Committee on Finance, along with Representatives Lloyd Doggett (D-TX), Chairman of the House Ways and Means Health Subcommittee, Brian Fitzpatrick (R-PA), and Bill Pascrell (D-N.J.), yesterday sent letters in support of recommendations that the device identifier portion of unique device identifiers (UDIs) be added to the standard information on electronic health insurance claims forms. Their letters were sent to Department of Health and Human Services (HHS), the Center for Medicare and Medicaid Services (CMS), and the X12 Committee, which sets industry standards for commonly used medical forms and recently issued a recommendation to include the device identifier portion of UDIs on electronic claims transactions.

 

UDIs are serial numbers that are used to identify specific types of medical devices, including implantable devices like pacemakers or artificial joints. 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-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. In addition, while the FDA uses post-market surveillance to monitor problems with drugs and vaccines, it is limited in its efforts to monitor medical devices because UDIs are not tracked on claims forms.

 

For these reasons, patient advocates and lawmakers like Senators Warren and Grassley have long advocated for adding UDIs to the standard information on insurance claims forms. Such forms are a key source of data because they track nearly every interaction a patient has with the health care system, including with different providers and insurers.

 

“This overdue change will help to reduce health risks and costs to the Medicare system,” wrote the lawmakers in their letters. “Including this information in claims transactions will enhance post-market surveillance of potential faulty devices and streamline the process of identifying affected patients when problems arise.”

 

If the X12 Committee’s recommendation to include the device identifier portion of UDIs on electronic claims transactions is finalized, this change would also need to be adopted by CMS via rulemaking. In these letters, the lawmakers urged X12 to finalize the recommendation and CMS to adopt the recommendation and implement the change. The public comment period for the X12 recommendation ends November 30, 2019.

 

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