Device-specific information must be included on Medicare claims forms or patient safety will not improve, says Cybele Bjorklund, a Distinguished Visitor at the O'Neill Institute for National and Global Health Law at Georgetown University's Law Center.
Bjorklund, a former lead Democratic health staffer on the House Ways and Means Committee, praises the creation of a unique device identifier, but calls specific information on medical devices one of the "black boxes of health data," in a post at The Hill.
Because there's no way to know which devices are being used, she says, the Centers for Medicare & Medicare Services doesn't have information about procedures such as joint replacement. Without that information, she stresses, "policymakers will stay in the dark on a key variable that can have a significant effect on the quality and cost of care."
However, Bjorklund says CMS is opposing adding the data to Medicare claims because of costs to overhaul the form.
The Pew Charitable Trusts also came out last week in support of the UDI, but said in a report that it must be supported by both the private healthcare sector and government agencies.
"The potential of the UDI is achievable only through robust infrastructure and revised standards to support the documentation, use, and transmission of this information," the report's authors wrote.
Over the summer, the U.S. Food and Drug Administration issued draft guidance on a "marking" feature for medical devices with a UDI as part of a medical device postmarket surveillance system.
In addition, the 21st Century Cures Act includes a non-binding amendment in favor of including unique medical device identifiers in electronic health records. However, the legislation faces a rocky road as it heads to the Senate.
For more information:
- read The Hill post