Creating a New Process to Include Medical Device Information in Insurance Claims

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What was the project about?

Medical devices, such as pacemakers or stents, can help diagnose, treat, or prevent health problems. Companies that make medical devices label them with unique device identifiers, or UDIs. UDIs contain data about a device, such as the make, model, and expiration date. Healthcare providers can scan UDIs when they use the devices and record UDI data in patients’ health records.

Right now, UDI data can only be accessed by the health systems that use the devices. Having the UDI data in insurance claim forms, instead of only in patients’ health records, would mean that researchers could look at data over time and across health systems. They could then use these data to help monitor devices for safety or study questions like how well devices are working.

In this study, the research team created ways to send UDI data from health systems to insurance claims forms.

What did the research team do?

The research team worked with two health systems and insurers to make processes and software to send UDI data to insurance claims. To do this, the team

• Created and tested processes in each health system to use barcode scanners to capture UDI data
• Found places on insurance claims forms to report UDI data
• Created software to send UDI data to claims forms
• Created a method to help insurers analyze the UDI data in the claims forms

The research team manually reviewed insurance claims data to see if the software sent the right data to the insurance claims forms.

Patients with medical devices, healthcare providers, health technology professionals, and insurers helped design the study.

What were the results?

In both health systems, the processes and software were successful in merging the UDI data in insurance claims.

What were the limits of the project?

The study included only two large health systems. Small health systems with limited resources, such as old technology, may need more work to send UDI data to insurance claims.

Future research could look at how to transmit UDI data from health systems to insurers on a national level.

How can people use the results?

Researchers, health systems, and insurers can use the processes and software to help monitor medical device safety using UDI data.

Background

Since 2014, manufacturers of medical devices have labeled their products with unique device identifiers (UDIs) to track safety concerns. Healthcare staff scan UDIs at the point of care and record them in patients’ electronic health records (EHRs). UDIs include data such as the make and model of a device and expiration date. However, UDIs are mostly accessible only by healthcare systems that implanted the device.

Insurance claims data use a more standardized format than EHRs, track patients over time and across providers, and are larger than individual healthcare EHR databases. Thus, they are better able to track devices longitudinally and provide a larger sample from which to monitor safety and efficacy. However, health systems currently do not have a process for transmitting UDIs from a provider to a health insurer. This capability could improve device surveillance and provide data for comparative effectiveness research.

Objective

To develop a process to transmit UDIs recorded at the point of care to the insurance claims of a health insurer

Study Design

Methods and Results

Researchers worked with two health systems and their respective health insurers to develop a process and software to link and transmit UDI data to insurance claims. To do this, researchers

• Developed and implemented processes in each health system to capture UDI information through barcode scanners
• Identified locations on claims forms to report UDI information
• Developed and implemented software for transmitting UDI information captured at the point of care to the selected location on the claims form
• Developed and implemented a method for analyzing claims forms received by the health insurer that involved integrating data into the health insurer’s claims processing system

Researchers manually reviewed claims data to see if the software sent the right UDI data to the claims form.

Researchers found that, in both health systems, the processes and software successfully integrated UDI information with insurance claims. For one health system, researchers determined integration success by confirming that the number and values of UDIs received by the insurer matched the number and values transmitted by the health system. For the other health system, researchers determined integration success by confirming that UDIs appeared in claims for every patient who received a device at the health system.

A group of patients with medical device implants, clinicians, health information technology (IT) professionals, and health insurers helped design the study.

Limitations

The study included only two large health systems. Smaller health systems with more limited resources, like older information technology systems, may face additional challenges in making the necessary IT changes to support UDI linkage and transmission to insurance claims.

Conclusions and Relevance

Researchers created methods and software to incorporate UDI information into claims data. Health systems and health insurers can use these methods and software to improve device surveillance and provide data for comparative effectiveness research.

Future Research Needs

Future research could assess provider and health insurer needs to incorporate UDI linkage into their systems on a national level.