Support is growing for unique device identification (UDI) tools to be used in insurance claims for implanted devices. Proponents say implementing UDIs into insurance forms is a necessary step for the Centers for Medicare & Medicaid Services (CMS) and private insurance bodies to track and measure device failures, reduce costs, and improve outcomes.
Who is responsible?
The Accredited Standards Committee (ASC) X12, chaired by Gary Beatty, is responsible for developing consensus-based standards to simply administrative efforts for healthcare.
On July 13, 2016, Health and Human Services (HHS) asked the committee to incorporate device identifiers (DIs) into insurance forms. Right now, some private insurers have added such data to their forms, but the data collection is unstructured and company specific, which prevents big data. CMS, which often influences how private insurers set pricing, has yet to implement any such process.
Who supports the change?
Supporters include HHS, several private insurance firms, hospitals and hospital purchasing organizations, surgical societies, patient advocacy groups, and healthcare research organizations.
Pew Charitable Trusts recently released “Unique Device Identifiers Improve Safety and Quality,” stating that both electronic health records and insurance claims should include UDIs. It also provides a list of organizations that have voiced support.
How will it help?
According to Pew, documenting UDIs in EHRs and insurance forms offers distinct and complementary benefits. However, it says that each is insufficient on its own to effectively realize the potential of this UDI system.
With respect to EHRs, Pew says UDIs support patient safety by providing clinicians with device-specific information to identify patients with recalled devices and ensure that they obtain appropriate care. They also alert clinicians at the point of care about clinically relevant information such as device expiration or MRI compatibility. These data points enhance clinical decisions and care coordination, even if adverse events happen years after implantation. Further, supply chain, billing, and other systems are able to access product information to improve overall hospital systems.
When used in claims documents, UDIs offer an opportunity to enhance population health data and feedback on device performance. Over many years and with millions of patients, such a large bank of data could help researchers determine how a particular medical intervention correlates to a particular outcome. According to Pew, claims data “have already been used to detect an association between a vaccine and an intestinal disorder in infants, compare mortality and readmission rates among hospitals, and evaluate preventive services, including cancer screenings.”
The data could be used to compare brands of products, such as cardiac stents. Likewise, health plans could use device selection among its care factors to improve outcomes and cost modeling.
In addition to data-driven analysis, analysts and proponents says adding UDI data to claims documents will allow FDA to extend its Sentinel Initiative for post-market surveillance for devices.
As Medicare and other health plans continue to prioritize value, they need better information about device performance. This information can help identify when lower- or higher-cost products may be clinically appropriate.
Health plans can use UDI information to ensure that patient members receive follow care and inform patients when recalls are issued. Further, health plans could use UDI data to detect fraud and recoup payments owed to them when products fail.
What needs to happen?
Right now, claims cannot be used because they only list procedures, and do not include any information on the implanted products. Hospitals and health plans cannot unilaterally add a field to claims for UDIs. For data to be accesses, it must be standardized. The claims form is regulated by CMS and is not updated often. The last update was in 2012, and might not be revised until 2021. 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 needs to require CMS to support the creation of a field to document UDIs for implanted devices as part of the next claims form update, says the Pew document.
Beyond an act of Congress, the process for implementing this change is admittedly complex. It would require providers and payers to modify their workflows and processing systems, an expensive undertaking. Medicare, as well, would require a significant upgrade in its legacy computer systems.
Medical device manufacturers are still working to implement UDI into their own processes. Getting that information into claims forms will likely be a long undertaking.