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Lawmakers Advocate For Simplified Medical Device Tracking

Last modified: Sep 29, 2022

On November 26th, a group of lawmakers sent letters supporting the recommendation of adding the “device identifier” portion of unique device identifiers (UDIs) to the information on electronic health insurance claims forms. UDI refers to a serial number that identifies various types of medical devices such as artificial joints and pacemakers. 

The lawmakers are well aware of the fact that there are medical devices that could be dangerous to the public, in case of recalls and failures. Hence, they’re making efforts to simplify medical device tracking. 

According to their recent press release, once the device fails, it can be difficult to trace which patients would be affected. This could potentially lead to serious health risks and increased healthcare costs. 

Based on the HHS-OIG report back in 2017, seven cardiac devices that failed had already cost insurance providers $1.5 billion in Medicare payments and the beneficiaries $140 million in out-of-pocket costs.     

Even though the FDA keeps track of drug and vaccine problems via post-market surveillance, the lawmakers believe that their efforts are lacking when it comes to monitoring medical devices since UDIs weren’t tracked on electronic claims forms. 

Moreover, the lawmakers think that changes in the claims forms would lower costs and health risks in the Medicare system. In addition, the process of identifying affected patients, due to faulty devices, would be streamlined as well. 

The lawmakers who showed strong support in simplifying medical device tracking include US Senators Elizabeth Warren and Chuck Grassley, and State Representatives Lloyd Doggett, Brian Fitzpatrick, and Bill Pascrell. 

Their letters were received by the Center for Medicare and Medicaid Services (CMS), the Department of Health and Human Services (HHS), and the X12 Committee. When the recommended change to the electronic claims forms is approved, the CMS would be required to adopt it via rulemaking.

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