June 13, 2013
Walter G. Suarez and W. Ob Soonthornsima Co-Chairs of the Subcommittee on Standards National Committee on Vital and Health Statistics National Center for Health Statistics
Centers for Disease Control and Prevention
3311 Toledo Road
Hyattsville, Maryland 20782
RE: Updates on the Unique Device Identifier System
Dear Dr. Suarez and Mr. Soonthornsima:
We would like to bring to your attention recent updates regarding the unique device identifier (UDI) system under development by the U.S. Food and Drug Administration. The Subcommittee on Standards of the National Committee on Vital and Health Statistics (NCVHS) received presentations on this UDI system last June. Since then, the FDA committed to finalize the UDI regulations by the end of the month and there are initiatives underway to include device identifiers in electronic health information— particularly claims transactions and electronic health records. As supporters of the efficient and effective implementation of the UDI system, we look forward to obtaining feedback from NCVHS, particularly regarding claims transaction changes.
The Pew Charitable Trusts is an independent, non-profit research and public policy organization. Pew seeks to enhance medical device safety and foster medical device innovation that benefits patients.
The UDI system—under development by the U.S. Food and Drug Administration (FDA)—will serve as the cornerstone for significant improvements in medical device safety and quality. Through this system, medical device labels—and, where appropriate, the device itself—will bear a unique code corresponding to the products manufacturer, model and other clinically relevant information. This UDI system will benefit patients, clinicians, hospitals, and public health officials by:
• providing for more rapid identification of medical devices associated with adverse events;
• assisting with prompt and efficient resolution of device recalls;
• delivering an easily accessible source of definitive device identification; and
• increasing health savings through a more accurate accounting of the devices used.
Realizing the full benefits of this UDI system requires that these identifiers are regularly included in electronic health information—particularly insurance claims transactions and electronic health records. To that end, Pew is urging federal advisory committees to the Office of the National Coordinator for Health Information Technology to recommend new EHR certification criteria to facilitate the
documentation of device identifiers along with a new core meaningful use objective to encourage eligible hospitals to capture UDIs for implanted devices in patient's medical records. We also submitted a request to the Accredited Standards Committee (ASC) X12—an organization that maintains insurance- related business process standards—on June 5 to make the necessary changes to enable the documentation of UDIs in claims transactions.
UDI incorporation in claims transactions
Claims transactions currently do not include details on the specific medical devices used by clinicians. As a result, health plans and health systems lack a process to efficiently collect information on the safety and quality of different medical devices.
UDI capture in claims transactions will contribute critical data to improve patient outcomes and enhance the evaluation of medical device safety, quality and performance. Unlike other electronic health information sources, claims transactions can provide longitudinal data on patient outcomes across healthcare institutions and for prolonged follow up times. These capabilities are critical for implanted medical devices, as problems might not emerge for several years and patients may seek care in facilities that did not perform the implant procedure.
The California Department of Health Care Services (DHCS)—which administers the state's Medicaid program—concluded a pilot program to determine whether the capture of device identifiers could yield benefits beyond the current Healthcare Common Procedure Coding System (HCPCS), which does not distinguish between specific devices. As a national UDI system for all devices had not yet been implemented, DHCS secured a temporary Health Insurance Portability and Accountability Act (HIPAA) exemption from the U.S. Department of Health and Human Services to evaluate the feasibility and cost- effectiveness of capturing in claims transactions the Unique Product Numbers for durable medical equipment and products sold in retail pharmacies. DHCS found that documenting device identifiers in claims transactions yielded several benefits, including more precise identification and payment for medical supplies; additional detail to enable rebate collection from manufacturers; streamlining claims processing procedures; reducing fraud and abuse; increasing data quality to provide enhanced payer control over rate setting and other business processes; and improving patient care by ensuring that products meet quality standards.
Lastly, documenting UDIs in claims transactions will support the FDA's postmarket surveillance Sentinel Initiative—which relies heavily on claims transactions to evaluate the safety of medical devices once they are approved, a capability that Congress has now directed for devices in the statute mandating the development of the device identifier system. By proactively monitoring data, rather than relying on spontaneous reporting, Sentinel can more systematically and quickly identify safety and quality issues on more than 100 million patients. However, without device identifiers in claims transactions to track the products used, Sentinel cannot effectively evaluate patient outcomes related to specific devices.
We recognize that there are still a number of issues that require additional exploration. For example, should providers document the UDI of all implanted devices used in a procedure, or only that of the primary device? Are there non-implanted devices whose UDI is appropriate for including in claims transaction? To obtain these additional details on UDI use in the claims process, we will conduct outreach to relevant stakeholders, including health plans, health systems and clinician organizations.
With the imminent establishment of a UDI system, there is now an opportunity to ensure the adoption of device identifiers throughout the health care delivery system. We look forward to obtaining NCVHS' perspective on this critical topic to ensure that we are maximizing this opportunity to implement an effective UDI system that will improve device quality and patient outcomes.
Should you have any questions or if we can be of assistance to help realize this important advance in evaluating the safety and quality of medical devices to improve patient care, please contact Josh Rising, director of medical devices, at The Pew Charitable Trusts, at 202-540-6761 or [email protected].
Josh Rising, MD
Director, Medical Device Initiative
The Pew Charitable Trusts