Unique device identifiers should be added to Medicare claims so the costs of recalled or prematurely failed medical devices can be identified and tracked, a federal watchdog agency said.
The Department of Health and Human Services Office of Inspector General recommended adding the identifiers to Medicare claims in a report issued Oct. 2, because the costs of all recalled or prematurely failed devices can’t be determined using only data on current claims. The lack of information prevents the Centers for Medicare & Medicaid Services from fully understanding and addressing these costs, hindering its and the Food and Drug Administration’s ability to identify poorly performing devices as quickly as possible, the OIG said in the report, dated September 2017.
The CMS said in a response to the report it is considering adding UDIs to the next version of claims forms, expected at the earliest in 2021.
This issue “underscores the lack of coordination among federal agencies,” Bloomberg Intelligence analyst Brian Rye told me. The FDA “issued a final rule establishing a UDI system for medical devices four years ago, but it has no oversight of Medicare or Medicaid claims forms.”
The FDA in September 2013 issued a final rule creating the UDI system, which requires labels and packages of medical devices distributed in the U.S. to include a unique device identifier unless the agency grants an exception or alternative.
Ben Moscovitch, manager of health information technology at the Pew Charitable Trusts, told me “many organizations across the health-care industry support the addition of device identifiers to claims.” He said these include large hospital systems, clinical societies that represent physicians who implant these devices, some device manufacturers, and some health plans such as Aetna.
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