Posted 13 April 2016
By Michael Mezher
The Pew Charitable Trusts says that adding unique device identifiers (UDIs) to insurance claims forms is critical to the success of several federal initiatives to improve medical device safety and patient care.
Dr. Josh Rising, director of healthcare programs at Pew, told Focus on Wednesday about his organization's efforts to improve device surveillance and how incorporating UDIs into claims forms can aid those efforts.
"The goal of Pew's medical device project is to improve the surveillance of devices after they enter the market. There have been recent high profile examples like metal-on-metal hip [implants], defibrillator leads and surgical mesh that show we need to build a better system so that when there are problems with devices we can quickly identify those problems and remove them from the market," Rising said.
Device Safety and Performance Monitoring
Congress first required the US Food and Drug Administration (FDA) to implement a system for UDIs in the 2007 Food and Drug Administration Amendments Act. The act also required FDA to develop a system for active postmarket safety monitoring for drugs and biologics, which was later expanded to include medical devices. That system, known as Sentinel, recently transitioned out of its pilot phase.
Rising told Focus that UDI has the potential to vastly improve postmarket monitoring for devices. "Now, all high risk and implantable devices are appearing with what is essentially a barcode on the packaging. That can give hospitals and [doctors] a very specific way to make sure they know the device that was used and get that information in the record."
However, FDA is only able to regulate UDIs for device manufacturers. According to Rising, "It's now up to the healthcare system as a whole to make sure they're using this new tool in an effective way." In his view, this can only be done through incorporating UDIs into both electronic health records (EHRs) and insurance claims forms.
When asked what makes UDIs so critical to safety surveillance efforts, Rising said, "The key to understanding medical device performance is being able to pull together information from a bunch of different sources to understand what's happening with the device. If you don't have a specific way to identify that device, it becomes very difficult … to pull information together on the device's performance."
This has long been possible for drugs using what's called a national drug code (NDC). According to Rising, NDCs make it "very easy to use claims or other data sources to understand what's happening with pharmaceuticals."
According to Rising, "One of the biggest challenges with medical devices is that you really need to understand patient outcomes over a lengthy period of time. If you receive a new hip you want to make sure that hip is going to be working for ten or 15 years … and following patients to get their outcomes for that period of time can be very difficult if you're relying just on electronic health records."
The Time to Act
Currently, electronic insurance claims data are built around standards set by the Accredited Standards Committee X12 (ASC X12), which updates its standards every eight or nine years.
Based on where ASC X12 is in the revision cycle, Rising believes there's a narrowing opportunity to incorporate UDIs into the upcoming revision, which is expected to be rolled out in 2021. According to Rising, this would give healthcare systems "plenty of time to implement any needed IT changes."
"If we miss this open window to put [UDIs] on the claims form … we're talking something like 2030 for the next version … waiting that long is simply unacceptable," Rising said.
UDI Impact on Federal Programs
In January, the Centers for Medicare and Medicaid Services (CMS) proposed a rule that would allow certain qualified entities access to Medicare claims data to perform analyses that could lead to better healthcare decision-making.
However, Rising says the proposed rule will do little to improve our understanding of device safety unless UDIs can be incorporated. Currently, Rising says, "If you want to know if a device is associated with a certain problem or has a high failure rate, right now you're unable to use claims data to answer that relatively straight-forward question."
When asked about the impact of UDIs on FDA's Sentinel Initiative, Rising said that the lack of UDIs in claims data limits what FDA can do to track device safety.
"Sentinel relies almost exclusively on claims data to run its analyses, so if you don't have UDI in claims it's really impossible for FDA to expand Sentinel to do things in the same way that it does for drugs or biologics. It really is the critical missing link for Sentinel," Rising said.
However, not everyone is supportive of integrating UDIs into insurance claims forms.
Last month, CMS' resistance to incorporating UDIs in claims forms prompted a letter to the agency from Senators Elizabeth Warren (D-MA) and Charles Grassley (R-IA).
In the letter sent to HHS Secretary Sylvia Burwell, CMS Acting Administrator Andy Slavitt and FDA Commissioner Robert Califf, Warren and Grassley call such a system "a critical tool to better detect adverse events, facilitate product recalls and enable robust post market surveillance."
Additionally, in its public comments on a report making recommendations for a national medical device evaluation system, the medical device industry group AdvaMed said incorporating UDI into claims forms would be "a costly proposition" and would "pose significant operational challenges."
When reached for comment, an AdvaMed spokesperson told Focus:
"The medical technology industry has long supported the development of a unique device identification system (UDI) to facilitate more accurate reporting, review and analysis of postmarket data for medical devices. We support efforts to incorporate UDI information in EHRs, and believe that reducing existing obstacles to the adequate identification of medical devices is a laudable goal. However, implementation of the UDI system as part of billing or hospital claims forms is a challenging and complex proposition, one that should be carefully evaluated to ensure that its ongoing use is practical and of value to patients, health care providers, industry and government. If the stated goal of adding UDI to hospital claims forms is to improve postmarket surveillance, there are other avenues to do this that would not lead to unnecessary burdens on hospitals."