Patients rely on medical devices to replace failing joints, fix irregular heart rhythms, test blood sugar, diagnose diseases, and improve their health in other ways. While millions of people use these devices on a daily basis, researchers—including those in the federal government and at private organizations—lack an efficient way to track the performance of these products and quickly detect safety problems.
To address this concern, Congress required the Food and Drug Administration (FDA) to create a system to provide medical devices with a unique device identifier (UDI) that corresponds with the product’s manufacturer and model type.1 The UDI system can provide patients and physicians with key information on the devices used in care, such as the precise model of a hip implant that is causing pain and may require revision surgery.
FDA, the National Medical Device Postmarket Surveillance System Planning Board, and many public health organizations, hospitals, and clinical societies agree: The new UDI system can only deliver on Congress’ vision once it is actually used throughout the health care system, including in both electronic health records (EHRs) and insurance claims. Documenting UDIs in these data sources offers distinct and complementary benefits. Each is insufficient on its own to effectively realize the potential of this new device identification system.
Incorporating the UDIs of implanted devices in EHRs can enhance care for individuals as well as enable clinicians to better treat their patients.
Given the importance of UDIs for patient care, federal regulations issued in 2015—with the support of many hospitals, clinical societies, patient organizations, and public health groups—will ensure that EHRs can incorporate the identifier and send it from one provider to another.2
However, the inclusion of UDIs in EHRs alone is insufficient because this measure will not effectively support large-scale population health analyses to detect problems quickly. The inclusion of UDIs in insurance claims can fill that gap.
To better understand care quality, researchers track data on patients over many years, often using claims for this purpose because they contain data for nearly every encounter with the health care system for a specific individual. For example, claims information collected over many years may contain data showing that a patient received a specific prescription drug, had surgery, and visited the emergency department. When used across millions of patients, researchers can begin to understand whether a particular medical intervention, such as a drug, correlates to a particular outcome, such as stroke. Claims data have already been used to detect an association between a vaccine and an intestinal disorder in infants,3 compare mortality and readmission rates among hospitals,4 and evaluate preventive services, including cancer screenings.5
Given these benefits, the Centers for Medicare & Medicaid Services (CMS) has recently launched several initiatives to increase the use of claims data for research to improve care quality and reduce costs.
Claims cannot be used to study medical devices for one simple reason: Claims currently list only the procedure— such as hip replacement surgery—and lack any specific information about the product implanted in the patient. Adding UDIs to claims would provide that specificity and allow researchers to use this data to assess devices more effectively.
Incorporating the UDI into claims forms could allow quick identification of poorly performing devices and alert relevant stakeholders earlier when defective devices need to be replaced or monitored. As a result, beneficiaries implanted with recalled products could receive appropriate follow-up care more quickly. Finally, CMS could use the data to make better coverage and reimbursement decisions.Daniel R. Levinson, U.S. Department of Health and Human Services inspector general, in a September 2015 letter to Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA)
Because of EHR interoperability challenges, certain FDA postmarket surveillance goals can be accomplished only using claims data. EHRs code information in varying ways and cannot easily exchange information. As a result, researchers face many challenges in combining EHR data across providers to understand quality and value. Claims, on the other hand, are already standardized across providers and payers, resulting in easier aggregation of information throughout the health care system. Adding UDIs would allow regulators and researchers to use claims to evaluate devices in the way in which they already evaluate drugs and procedures.
Given the many benefits, organizations across the health care ecosystem—including several multistakeholder groups of experts—have emphasized the importance of UDIs in claims. Organizations that have expressed support include:7
|Aetna||American Joint Replacement Registry|
|Alliance of Community Health Plans
||Pacific Business Group on Health
|Geisinger Health System
|National Medical Device Postmarket Surveillance System Planning Board
||West Health Institute
|American College of Cardiology
|The Society of Thoracic Surgeons
||National Health Council
|American Academy of Orthopaedic Surgeons
|Food and Drug Administration
||Trust for America’s Health
|National Association of Accountable Care Organizations
Currently, billing data contain the most comprehensive records on individual patient encounters. Due to the lack of interoperability within and across provider systems, patient EHRs are not capable of communicating events such that devices can be tracked over time as patients move between providers. Therefore, the capture of UDIs through claims data provides useful information linking patients to specific devices across provider systems and over time.Unique Device Identifiers (UDIs): A Roadmap for Effective Implementation, The Brookings Institution
Hospitals and health plans cannot unilaterally add a field to claims for UDI information. The claims form, regulated by CMS, is standardized across health plans and providers and is updated infrequently. As a result, plans and providers that want to document UDIs in claims are unable to do so until a change is made. The last update took effect in 2012, and the form might not be revised until 2021 or later.8 Given that changes for the next update are decided well in advance to allow for an implementation period, the window for adding UDIs to claims is rapidly closing.
Congress should require that CMS—as part of the next claims form update—support the creation of a field to document the UDIs of implanted devices. This common-sense solution would help protect patients from unsafe products and provide clinicians, researchers, and regulators with the data they need to improve quality for the millions of Americans who rely on medical implants.