The Department of Health And Human Services (HHS) Inspector General Daniel Levinson recently called on CMS to work with Accredited Standards Committee (ASC) X12. The call was to incorporate Unique Device Identifiers (UDIs) for implantable devices in the current insurance claims forms.
Levinson said that doing so would help CMS to keep tracks of the costs associated with the medical devices that are recalled or defective and also improve the safety of patients. Experts note that this call comes months after the letter from CMS’s Acting Administrator, Andy Slavitt, and FDA Commissioner, Robert Califf, to ASC X12 Chair, Gary Beatty, calling to incorporate UDIs into next claims forms. The next version claim forms are to be proposed on December 1, 2016.
Unique Device Identifiers
The Congress first asked FDA to implement a system for UDIs in the amendments that were made to the Food and Drug Administration Act in 2007. Despite the challenges of rolling out UDIs, the biggest battle was over the decision to incorporate UDIs to insurance claim forms.
People who support incorporating UDI into claims form argue that the resulting data can make it very easy to track the safety and performance of these devices. However, the medical device industry groups like AdvaMed firmly opposed the move to incorporate UDIs into the insurance claim forms, as they believe that this will be very costly and have many challenges.
HHS OIG Review
Levinson found it difficult to come up with exact figures last year on how much Medicare had spent on the recalled or failed devices, when asked about it by Senators Elizabeth Warren (D-MA) and Charles Grassley (R-IA). However, he now says that a preliminary review of the Medicare spending on recalled or failed devices showed that it has spent 1.5 billion dollars on procedures and services for just seven devices for heart that were either recalled or had high failure rates.
“Our ongoing review shows that the lack of medical-device-specific information in the claims data impedes the ability of the Centers for Medicare & Medicaid Services to readily identify and effectively track Medicare’s total costs related to the replacement of recalled or defective devices,” Levinson said. However, CMS is yet to come up with any decision on incorporation of UDIs in claim forms.