July 28, 2023

Jackie Monson, J.D., Chair
The National Committee on Vital and Health Statistics (NCVHS)
3311 Toledo Road
Hyattsville, MD 20782-2002

Re: NCVHS Recommendation on the Updated Version of the X12 Standard for Claims and Electronic Remittance Advice Transactions (Version 008020)

Dear Ms. Monson,

This letter is in response to your June 14, 2023 letter to Secretary Becerra regarding recommendations on updating the X12 standards for the electronic claims and remittance advice. While we are disappointed with the ultimate recommendation and what it means for inclusion of UDI in claims data, we are hopeful that the reasons cited by the committee to not move forward will be resolved soon.

In your letter, you encouraged the FDA to review the stakeholder comment letters and testimony to identify concerns submitted to NCVHS regarding the collection of Unique Device Identifier (UDI) information. We would like to assure you that we have reviewed the comments submitted and are engaging with stakeholders to address unresolved concerns.

Based on our engagement with the X12 organization and other interested stakeholders, the inclusion of UDI in the standard electronic claim has been a topic under discussion since 2013. The Pew Foundation, with support from Mercy Hospital, Geisenger Health, and Aetna submitted a change request to the X12 organization for that inclusion into the X12N 837 claim transaction, and a “Business Request and Technical Solutions” (BRTS) document was created detailing the need for the data element and use cases if it was approved.

This proposal generated significant discussion and led to the creation of a Special Advisory Committee (SAC) to focus on this one task. The SAC had representation from providers, health plans, vendors, and associations such as the American Hospital Association (AHA) and the American Medical Association (AMA), and included stakeholders both for and against the inclusion of UDI in the standard. The committee held extensive discussions on the benefits and risks of UDI inclusion, and potential solutions for implementation. Issues such as cost, burden, overlap with electronic health record (EHR) data, use of the Global Unique Device Identification Database (GUDID), definition of high-risk, and the potential value and use of the Device Identifier (DI) were debated and discussed. X12 management made sure that this committee conducted fair and open hearings.

The final recommendation from the SAC was to create a new segment in both the institutional and professional claim to enable the transmission of just the DI portion of the UDI, for high-risk implantable devices; only if both the provider and health plan agreed to the exchange. This compromise was made to address concerns raised regarding the burden on providers and health plans for inclusion of UDI in claims. The recommendation went through the full X12 approval process which includes public comment, and eventually was approved for inclusion in the electronic claim version.

Concerns raised via public comments and public hearing regarding inclusion of UDI are similar to those that were raised during the SAC deliberations. From our perspective, these were and have been addressed via the compromise reached. While some comments indicate that capture of UDI in EHRs is sufficient for clinical context and addition to claims is not necessary, many comments point out the importance of having UDI in claims to ensure ability to capture longitudinal information on patient care delivery and outcomes across the continuum of care, sites and providers. The UDI2Claims project, funded by The Patient-Centered Outcomes Research Institute or PCORI, highlights the value of having DIs in claims for device performance evaluation throughout the continuum of care. There have also been pilots at several hospitals demonstrating the ease of getting the DI into the revenue cycle system and electronic claim; see Transmitting Device Identifiers of Implants From the Point of Care to Insurers: A Demonstration Project - PubMed (nih.gov).

Several comments indicated a lack of clarity around what is deemed a ‘high-risk’ implantable device. While determination of which devices are high risk implantable medical devices are to be mutually agreed upon by willing trading partners, as a point of reference, FDA generally considers implantable devices to be high risk devices and currently makes available a list of Implantable devices on AccessGUDID, which is the public portal for device identification data, submitted to the GUDID. We have been in discussions with key stakeholders such as AMA and AHA to better understand data needs and standby to develop additional tools and lists as needed to address any gaps and work to improve clarity with regards to device identification needs to support inclusion of UDI in claims.

Please be assured that the FDA will continue to work with stakeholders to address barriers to implementing the use of UDI in the claim transaction.

Inclusion UDI in claims will be transformational for patient safety. While capabilities exist today to capture UDI in electronic health record systems, there is no efficient way to track device effectiveness and patient outcomes throughout the continuum of care. This is especially critical for high risk devices such as implants, as patients often seek post-procedural care elsewhere, and not where the initial implantation took place. Data captured in disparate and siloed electronic health record systems are often not accessible to patients or their caregivers when necessary. Claims data will provide the ability to capture information across the continuum of care, in addition to serving as a source of real world data, enabling better evaluation of device performance. For FDA, it will enable us to make better regulatory decisions with regards to new device approvals and responding to post market safety signals. Even though the current proposal limits UDI inclusion to high-risk implantables only, it is an important step towards enabling our healthcare system to begin realizing the full benefits of the UDI system.

We urge the committee to work expeditiously to resolve open issues with the Version of the X12 Standard for Claims and Electronic Remittance Advice Transactions (Version 008020) and recommend adoption so that UDI information can be captured and exchanged.

We are available to answer any questions you may have and look forward to future developments on this matter.

Sincerely,
Jeff Shuren, MD, JD