At the same time the U.S. Food and Drug Administration is pressing "full steam ahead" to develop a unique device identifier (UDI) system for medical devices, the Centers for Medicare & Medicaid Services is lobbying against its plan to use the UDI on claim forms.
Former Medicare Administrator Marilyn Tavenner has maintained that requiring the UDI on medical claims forms poses big technical hurdles and costs too much, the Wall Street Journal reported.
In a letter to two senators last month, Tavenner suggests that putting the UDI into electronic health records or device registries kept by companies should be sufficient to promote safety.
That position contrasts with that of Department of Health and Human Services Secretary Sylvia Mathews Burwell, who has written that the FDA's national drug-product safety net--the Sentinel Initiative--"will ultimately benefit" by "incorporating UDIs into its claims data sources."
Mark McClellan, a senior fellow at the Brookings Institution and a former Medicare administrator, told WSJ that Tavenner was "channeling the concerns of hospitals" that billing changes could be expensive for them, too.
In a statement, the agency said it is working "to better understand and document the value, benefits and cost" of the UDI system.
Groups including AARP, Pew Charitable Trusts and the American College of Cardiology are among those advocating that the numbers be part of Medicare bills, according to the article. And some lawmakers have expressed concern that without CMS' lead, insurance companies won't collect and use the UDI data either.
Pew Charitable Trusts and others have urged making the UDI a required field in EHRs as part of as part of Meaningful Use Stage 3, FierceEMR has previously reported.
After the FDA's five-year pilot, the Mini-Sentinel program, used for medical product safety monitoring, is ready to move to the full-scale system, the agency announced in January.
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