The Pew Charitable Trust and 12 other organizations have weighed in on the rule implementing Stage 3 of the Meaningful Use program, supporting the Centers for Medicare & Medicaid Services' decision to include unique device identifier (UDI) requirements.
In a letter commenting on the rule, the signatories--which include Geisinger Health System, Kaiser Permanente, The Leapfrog Group, and the American Academy of Orthopedic Surgeons--noted that the rule requires a field in EHRs to list the UDI and information about the product, such as whether it is compatible with magnetic resonance imaging. The rule also requires the incorporation of UDI data in summary of care information, referred to as the Common Clinical Data Set, and supports the exchange of UDI information by requiring the transmission of CCDS.
The letter notes that this transmission will become even more important as the industry moves to increased care coordination and the Merit-Based Incentive Payment System (MIPS) created this past spring in the Medicare Access and CHIP Reauthorization Act.
Incorporating UDIs into electronic health records, according to the letter, will help:
- Hospitals identify individuals implanted with recalled devices
- Physicians coordinate care for patients that see multiple clinicians
- Providers and patients access accurate information on products implanted
- Researchers conduct analyses of device performance using clinical data
The UDI system was developed by the Food and Drug Administration. It will provide medical devices with a code corresponding to its manufacturer, model and other relevant data, such as an expiration date. Pew has advocated the use of UDI in the past, most recently asking that National Committee on Vital and Health Statistics include such data in insurance claims forms. CMS opposes that idea, saying that putting UDI information in EHRs or device registries is sufficient to promote safety.
The rule implementing Stage 3 of the Meaningful Use program, released with a comment period, has had its share of detractors. Several lawmakers and provider groups have recommended that Stage 3 be delayed and refocused. The American Academy of Family Physicians said that it should be wholly transformed, while another group of organizations has warned that Stage 3 should not be delayed unless Congress enacts legislation to improve interoperability.
To learn more:
- here's the letter (.pdf)