CMS Proposes New UDI Measure Under Medicare Interoperability Program
The U.S. Centers for Medicare & Medicaid Services (CMS) has issued a proposed rule introducing a new measure related to the use of Unique Device Identifiers (UDI) within the Medicare Promoting Interoperability (PI) Program.
According to the proposal, eligible hospitals would be required to attest “Yes” or “No” to whether they use certified electronic health record technology (CEHRT) to capture the complete UDI for each implantable medical device subject to UDI requirements.
This measure is included under the Public Health and Clinical Data Exchange objective and has been developed in collaboration with the U.S. Food and Drug Administration (FDA).
UDI and electronic health records
The FDA states that capturing UDI data within electronic health records is a practical step toward achieving the objectives of the UDI system, particularly in relation to patient safety.
Accurate and consistent documentation of UDIs enables:
Precise identification of medical devices used in patient care
Generation of real-world data (RWD) and real-world evidence (RWE)
Improved capacity to monitor device safety and effectiveness over time
Established benefits of the UDI system
The FDA highlights that the UDI system, now fully implemented, provides several benefits across the healthcare ecosystem, including:
More accurate reporting, review, and analysis of adverse event data
Faster identification and correction of problematic devices
Reduction of medical errors through improved device identification
Standardized documentation of device use across electronic health records, clinical systems, claims data, and registries
More effective management of medical device recalls
Support for a more robust post-market surveillance system
Contribution to a globally recognized device identification system
Strengthening of the medical device supply chain, including addressing counterfeiting and diversion
Adoption across the healthcare system
The FDA notes that while the UDI regulatory framework is established, the full realization of its benefits depends on adoption by multiple stakeholders, including manufacturers, distributors, healthcare providers, payers, and patients.
Efforts to support adoption include collaboration with federal partners and external stakeholders, as well as initiatives to promote the integration of UDI into electronic health information systems.
Read the full document below.
