Millions of Americans are implanted with various medical devices each year, though the Centers for Medicare & Medicaid Services (CMS) still lacks the ability to track which devices prematurely fail or are recalled based on claims data.
At a hearing Tuesday at the Senate Health, Education, Labor and Pensions (HELP) committee, Sen. Elizabeth Warren (D-MA) called on CMS to update the Medicare claims form to include a line for the unique device identifier (UDI) to know more about the model of device and the manufacturer.
The Department of Health and Human Services' Office of Inspector General said in a September report that the lack of identifier information on claim forms prevents CMS "from being able to fully understand and address the Medicare costs related to recalled or prematurely failed medical devices. In addition, the lack of information impedes the Food and Drug Administration (FDA) and CMS's ability to identify poorly performing devices as early as possible. This diminishes device recipients' chances of receiving timely followup care."
Although CMS and FDA under President Barack Obama said they support the addition of device identifiers to claims forms, the current administration's CMS has said it is still reviewing the policy change and CMS' chief medical officer Kate Goodrich reiterated Tuesday that the agency is still reviewing the change.
"This should be a no-brainer," Warren said, noting that the addition of device identifiers to claim forms has bipartisan support and would reduce Medicare costs and better protect beneficiaries.
A section of the Food and Drug Administration Amendments Act of 2007 charged FDA with creating a UDI system for medical devices to facilitate better detection of adverse events, improve product recalls and enable robust postmarket surveillance.
In 2013, FDA promulgated a final rule establishing a UDI system designed to adequately identify medical devices through distribution and use.
UDIs contain two parts: the device identifier (DI), which notes the device labeler and the specific version or model of the device, and the production identifier (PI), which indicates one or more of the following when included on the device label: the device's lot or batch; its serial number; its expiration date; its manufacturing date; or its human cell, tissue or cellular, or tissue-based product identification code.
The standard Medicare and Medicaid health insurance claim forms do not currently include a field to capture data about either the DI or PI portions of the UDI for implantable medical devices.
Compliance Dates for UDI Requirements
SHORTCOMINGS OF DEVICE CLAIMS DATA COMPLICATE AND POTENTIALLY INCREASE MEDICARE COSTS FOR RECALLED AND PREMATURELY FAILED DEVICES