Section title: News
X12 Blog

New X12 Publications Support Inclusion of Device Identifiers

Once again, X12 meets industry needs through consensus-driven processes

By Cathy Sheppard, X12 Executive Director

In May 2021, X12 had the opportunity to respond to a bipartisan letter from U.S. Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa). The Senators' letter urged X12, the ANSI accredited National Standards Developer responsible for developing the related standards, to finalize its unique device identifier (UDI) recommendations for health care administrative transactions.

We commend Senators Warren and Grassley for tirelessly advocating on behalf of the American people to ensure UDI information is collected in both electronic health records (EHRs) and health care administrative transactions. X12 has proactively addressed this common-sense solution, standing with CMS, the FDA and numerous other organizations across the health care ecosystem.

Studies and audits conducted over the last decade revealed Medicare cost increases attributable to CMS’ inability to effectively identify and track medical device recalls and defects. The inclusion of UDI information in X12 transactions would reduce these cost inefficiencies.

A common goal

In a letter to Senators Warren and Grassley dated May 12, 2021, X12 Board Chair Stephanie Fetzer responded to their questions, outlining actions taken by X12 to support the handling of UDI information. Below is the body of the X12 letter for your easy reference.

X12 enhancements related to the inclusion of the device identifier (DI) portion of a medical device's unique device identifier are available for the health care ecosystem's use now; however, health care entities subject to HIPAA mandated transaction rules are still compelled to exchange an earlier version that does not support the exchange of UDI Information.

X12's next step is to recommend the enhanced versions supporting UDI information exchanges as federally mandated HIPAA transactions. Once that recommendation is submitted, the government’s multi-year federal clearance process can be initiated.

Those unfamiliar with the ins and outs of collecting unique device identifier data and why it matters may wish to review the FDA’s UDI information.

 

X12's response to the bipartisan letter

X12's revisions related to the inclusion of the device identifier (DI) portion of a medical device's unique device identifier (UDI) are complete and the impacted implementation guides are final and published. As you may know, the publication of updated implementation instructions is the first step in a multi-step federal process that we expect will result in a new HIPAA mandate requiring the health care industry to support the latest version of these X12 implementation guides. Such a mandate will not only support the inclusion of the DI information but also other functional enhancements that ultimately benefit consumers and other health care industry stakeholders.

Related to the specific questions in your letter:

  • X12 releases a new version of each of its implementation guides annually. The device identifier (DI) portion of a medical device's unique device identifier (UDI) requirements have been included in X12's published implementation guides since the fall of 2020, including version 007030, 008010, and 008020 (coming soon).
  • Detailed implementation instructions within X12 implementation guides support the following related to use of the UDI:
    • Within the X324 Health Care Claim: Institutional implementation guide:
      • DI information can be sent at the claim level or at the service level within a claim.
      • At the claim level, the information is transmitted in the High Risk Implanted or Explanted Device (CR8) segment (loop 2300) as needed to identify high-risk implantable devices or the explanting of such devices. A provider can send that segment 9 times, so it is possible to send 9 DIs at the claim level.
      • In addition, one DI can also be transmitted in the Drug/Supply Identification (LIN) segment (loop 2410) at the service line level of a claim as needed to identify drugs, biologics, and supplies or to support enhanced claim reporting.
    • Within the X323 Health Care Claim: Professional implementation guide:
      • DI information can be sent at the service line level of a claim, up to 50 service lines are permitted on each claim.
        • 20 repetitions of the CR8 segment (loop 2400) are supported for each service line as needed to identify high-risk implantable devices or the explanting of such devices.
        • In addition, one DI can be transmitted in the LIN segment at the service line level of a claim (loop 2410) as needed to identify drugs, biologics, and supplies or to support enhanced claim reporting.
      • X12 also supports the transmission of the full UDI, including the DI and the Product Identifier (PI), in its 277 Health Care Claim Request for Additional Information implementation guides and its 275 Additional Information to Support a Health Care Claim or Encounter implementation guides.
      • X12 is finalizing its recommendation related to the adoption of new versions of the health care claim transactions at this time and expects to present that recommendation to the National Committee on Health and Vital Statistics (NCVHS) this summer. NCVHS will hold hearings and make a related recommendation to the Centers for Medicare & Medicaid Services. If appropriate, CMS will draft an NPRM and Final Rule requiring implementation of the recommended version.