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You are here: Twin Peaks Group > Unique Device Identifier

What it will take to Create an Effective Post-market Surveillance System for Implanted Devices by 2025?

Posted at 1:25 pm on Apr 26, 2021 by

4 logosIn my last blog post – nearly 4 years ago! – I announced that I was co-investigator in a project to assess the feasibility of recording the unique device identifiers (UDI) of implanted medical devices in the operating room and transmitting them to insurance companies as part of the claim. At that time, our project had advanced to the point that we felt confident that we could successfully implement the process we had designed.

Our optimism was justified. Only modest changes to existing information systems at two hospitals and their insurance company partners were needed. And the designers and implementers of the modified systems told us that the effort required was comparable to a routine system upgrade. Based on our experience, we concluded that nationwide implementation of recording UDIs at the point of care and transmitting them to insurance companies would not be a major burden on most providers and insurance companies. In most cases, the modifications to their information systems would be made by their system vendors. You can read the details here.

Sentinel System

But how do you get from our demonstration to a post-market surveillance system for devices? Well, it helps to know there is already a post-market surveillance system for medications. It’s the Sentinel System, and it relies on the national drug codes contained in claims and electronic health records. It turns out that Sentinel’s mandate includes devices. Moreover, Sentinel has the data structure and processes that could be adapted to handle devices. So far, however, the US Food and Drug Administration (FDA), which facilitated the development of Sentinel, has not asked the contractor that runs Sentinel to extend its functionality to devices.

There is no point, however, in extending Sentinel‘s capability to handle UDIs in claims unless those UDIs are being transmitted in claims from providers to insurers. And that would mean that insurance companies – at least a substantial percentage of them – would need to ask providers to start including those UDIs in claims. We came to the conclusion, however, that this was unlikely because insurers might not see any individual benefits from having UDIs of implanted devices in their claims databases.

So, what might induce insurance companies to request that their providers include UDIs in their claims? To answer this question we interviewed a representative group of 20 UDI experts. The majority told us that if the Centers for Medicaid & Medicare Services (CMS) requested that their providers include UDIs in claims, the other insurers would follow its lead.

This led us to make two recommendations: We have called (1) for CMS to require its providers to include UDIs in their claims and (2) for the FDA to ask Sentinel’s contractor to extend Sentinel’s capabilities to include devices.

The title of this blog suggests that the post-market surveillance system for devices based on UDIs in claims could be ready by 2025. How did we arrive at that date? For that, I invite you to read our blog in Health Affairs, published on April 23, 2021.

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Enhancing the process for tracking implanted devices

Posted at 11:59 am on May 21, 2017 by

Most of us would find it strange that insurance claims include data on medications administered to the patient, but none for implanted medical devices, such as pacemakers, stents and artificial joints. For medications, the data take the form of codes that follow a prescribed protocol and facilitate monitoring for the drugs’ safety. For implanted devices, the claim forms sent to insurance companies list the procedure without any data on the device. And yet, such devices may pose safety problems because it is difficult to test them as thoroughly as medications.

A few years ago, the US Food and Drug Administration (FDA) developed a protocol for coding implanted devices, and mandated that manufacturers apply such codes – known as Unique Device Identifiers (UDIs) – on their devices or their packaging. The specificity of these UDIs lies somewhere between the vehicle number identification for an automobile (which is specific to an individual vehicle) and the barcode on a can of Coke (which may indicate its category and the volume of the can). Although manufacturers of high risk implantable devices are complying with the regulation, the FDA’s authority does not include requiring the use of UDIs in hospitals’ electronic health records or on claims. And there things stand.

Yet many have recognized the value of including UDIs on claims. First, insurance claims are universal, based on standards developed by the so-called X12 Committee, which developed the protocol for placing medication codes on the claim form. Second, including device identifiers on the claim would provide stakeholders, including patients, physicians, manufacturers, insurance companies and researchers access to better data on the performance of implanted devices over a long period of time. Third, in case of problems, patients could be tracked down and alerted even if they no longer live near the hospital where they received the implant or are covered by another insurance company.

In absence of an authority with the mandate to require the full-stream use of UDIs, initiatives are being taken to facilitate the inclusion of the device identifiers on claims, and demonstration projects are underway to demonstrate its feasibility. The X12 is facilitating the use of UDIs on claims: it has developed a proposal for a field on the claim form that would accommodate UDIs for up to eight implanted devices. On the hospital front, projects are underway to demonstrate the feasibility of moving UDI data from materials management systems to the electronic health record and on to device registries, which are repositories of data generally established by medical specialists. And last year, the Patient-Centered Outcomes Research Institute awarded a contract to demonstrate the feasibility of capturing the identifier for an implanted device at the point of use and transmitting it to an insurance company. The project is led by Joel Weissman, Deputy Director and Chief Scientific Officer of the Center for Surgery and Public Health at Brigham and Women’s Hospital in Boston, and I am a Co-Investigator.

Our project, which officially started in November 2016, has advanced to the point where we are confident that the process we envision will indeed work without interfering with established processes, and we are preparing for test runs. Our initial efforts are aimed at the Catheterization Laboratory (Cath Lab) of Brigham and Women’s Hospital, where cardio stents and valves are implanted. We had the good fortune to learn that UDI barcodes were already being scanned in the Cath Lab and captured into the electronic health record. However, nothing was being done with the data. The remaining challenges thus consisted of transmitting the UDI from the electronic health record into the hospital’s billing system and, from there onto a claim to be transmitted to an Insurance company.

We have just released a white paper describing the status in the Cath Lab and the plans for transmitting the UDI from there to Blue Cross Blue Shield of Massachusetts, our partner in this project. In addition to providing details on our process, the document includes background on UDIs and other projects aimed at their implementation in hospitals. I encourage you to read the white paper, particularly if you are interested in some of the details associated with the process of getting UDIs on to claims.

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