Posted 09 March 2016
By Michael Mezher
Senators Elizabeth Warren (D-MA) and Charles Grassley (R-IA) questioned the Centers for Medicare and Medicaid Services' (CMS) opposition to incorporating the unique device identifier (UDI) for medical devices into insurance claims forms.
By not adding UDIs to insurance claims forms, Warren and Grassley warn that Medicare is making it more difficult to monitor device safety, which has resulted in millions of claims that could have been avoided with better monitoring.
In September, HHS Inspector General Daniel Levinson wrote to the two senators, saying that "recalls of defective medical devices have likely resulted in millions of Medicare claims for monitoring services and device replacement-related procedures."
While Levinson was unable to come up with exact figures for the number of such claims, or the associated costs, he estimates that, "Medicare, and by extension the taxpayers, has most likely spent several billions of dollars" due to defective devices.
UDI and Postmarket Surveillance
Congress first required the US Food and Drug Administration (FDA) to implement a system for UDI 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.
To meet those requirements, FDA began developing a system for UDIs and launched its Sentinel Initiative for monitoring product safety. Last month, FDA officials announced that Sentinel had moved out of its pilot phase, but noted that UDI integration into insurance claims forms and electronic health records (EHRs) remains a major challenge.
UDI and Claims Forms
In the letter sent to Department of Health and Human Services (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."
"In addition to the patient safety benefits that the inclusion of UDI in claims can provide, inclusion may also help to protect the integrity of the Medicare program," by saving the system money through faster recalls and fewer claims due to defective devices, Warren and Grassley write.
The Senators say CMS must act quickly to endorse UDI incorporation in insurance claims forms as the group that creates the standards for electronic claims forms, the Accredited Standards Committee X12, is in the midst of developing the next version for claims forms, which is set to roll out in 2021.
When asked about the letter, Dr. Joe Drozda, director of outcomes research at Mercy Health System said, "I can only hope that this will change the conversation to one that’s focused on solutions. We don’t have much time left for arguing if we want to have UDI in the claim form in 2021."
This is not the first time Warren and Grassley have written to CMS over incorporating UDI into claims forms. In December 2014, the two sent a letter to CMS Administrator Marilyn Tavenner questioning her agency's opposition to including UDIs over cost and other technical challenges.
This opposition, the Senators now write, is in contrary to statements made by HHS Secretary Burwell and FDA Commissioner Califf, with Califf calling UDI incorporation in claims forms "a very high priority."
However, CMS is not the only entity opposed to incorporating UDIs into claims forms. Last year, the Advanced Medical Technology Association, a device industry group, commented on a proposal from FDA on establishing a National Medical Device Evaluation System, saying it would be "costly [and] pose significant challenges" to add UDIs to insurance claims forms.
Letter from Warren and Grassley on UDI