In Bipartisan Letter, Sens. Warren, Grassley Urge X12 Committee Finalize Its Unique Device Identifiers Recommendation for Medicare Claims Forms

WASHINGTON, April 21 -- Sen. Elizabeth Warren, D-Massachusetts, issued the following news release on April 20, 2021:

United States Senator Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) sent a letter to the Accredited Standards Committee (X12), the committee that sets industry standards for commonly used medical forms, urging them to finalize their recommendation that Medicare claims forms include the device identifier portion of a medical device's unique device identifier (UDI), which are serial numbers that are used to identify specific types of medical devices, including implantable devices like pacemakers or artificial joints.

Their letter to X12 follows the senators' November 2019 letters to the Department of Health and Human Services (HHS), the Center for Medicare and Medicaid Services (CMS), and the X12 Committee in support of this recommendation, which the X12 released in October 2019.

"Today, we write for an update on the status of the October 2019 formal recommendation. Specifically, we request information on when X12 plans to publicly release a final new version of the electronic claims transaction and whether that electronic claims transaction will include the device identifier portion of the UDI of high-risk implantable medical devices," wrote the senators.

Currently, when a device fails or is recalled, it can be difficult to identify which patients will be affected, leading to risks of complications and increased costs to the health care system. Medical device failures can cause serious health problems and financial costs: a 2017 HHS-Office of Inspector General (OIG) report found that recalls or premature failures of just seven faulty cardiac devices resulted in $1.5 billion in Medicare payments to providers and $140 million in out-of-pocket costs to beneficiaries.

"Including device identifiers on claims transactions would greatly improve the health system's ability to identify risks and reach patients who may be affected by device failures. Researchers can rely on claims data to track patients' interactions with the health system, even when the patient changes providers. As a result, the data can be used to establish population-level correlations between a particular treatment and a long-term outcome or side effect," the senators wrote.

Senators Warren and Grassley have extensively advocated for device identifier information to be collected in both electronic health records and on claims transactions since 2014:

* Prior to sending letters of support to HHS, CMS, and X12 in November 2019, the senators sent a letter to the Food and Drug Administration (FDA) to reiterate the importance of including medical device identifiers on the updated Medicare claim form and to urge the agency to maintain its support for this change in June 2018.

* In November 2017, Senators Warren and Grassley pressed CMS to clarify its position on the inclusion of medical devices' device identifiers on Medicare claim forms.

* In October 2017, both senators issued a statement in support of HHS-OIG's recommendation that the (CMS work to add device identifiers to Medicare claims in order to better track faulty devices.

* In February 2017, X12 released a draft update to health insurance claims forms that includes device identifiers. The senators commented on the proposal.

* In August 2016, Senators Warren and Grassley asked X12 about the steps it was taking to include medical devices' UDI on health insurance claim forms, and in October 2016, following the preliminary results of the HHS OIG ongoing review, the senators again urged CMS and X12 to include device identifiers on health insurance claim forms.

* In March 2016, Senators Warren and Grassley wrote to HHS, CMS, and FDA inquiring about the progress that had been made in adding the UDI of medical devices to health insurance claim forms.

* In December of 2014, Senators Warren and Grassley wrote to CMS expressing support for the inclusion of UDIs in claims forms and pressed CMS to work with other stakeholders on the benefits of a UDI system. In August 2015, the senators wrote another letter to the HHS-OIG requesting information about his review of the cost to Medicare incurred by defective medical devices and the challenges of obtaining this data absent a way to track medical devices through claims forms.

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April 19, 2021

To: Stephanie Fetzer, Chair, Board of Directors, X12, 1405 S Fern St #92957, Arlington, Virginia 22202

Dear Chair Fetzer:

We are writing to request an update on the institutional health care claim transaction released for public comment on October 2019./1 We applaud X12's recommendation to include a field for the device identifier portion of a medical device's unique device identifier (UDI) on the electronic claim transaction and are interested in learning when the transaction will be finalized.

Although medical device failures are rare, when they do occur, they can create serious health problems and significant financial costs. A 2017 investigation by the Office of Inspector General at the Department of Health and Human Services found that recalls or premature failures of just seven faulty cardiac devices resulted in $1.5 billion in Medicare payments and $140 million in out-of-pocket costs to beneficiaries./2 Furthermore, the Inspector General was not able to examine the total cost of all device failures because of the lack of information about specific devices in claims data. Instead, OIG examiners were forced to engage in a "complex and labor-intensive audit" to assess the impact of the seven faulty devices./3 As a result, the Inspector General recommended the addition of device identifiers to claims./4

Including device identifiers on claims transactions would greatly improve the health system's ability to identify risks and reach patients who may be affected by device failures. Researchers can rely on claims data to track patients' interactions with the health system, even when the patient changes providers. As a result, the data can be used to establish population-level correlations between a particular treatment and a long-term outcome or side effect./5

We have extensively advocated for device identifier information to be collected in both electronic health records and on claims transactions,/6 and in October 2019, the X12 Accredited Standards Committee released a formal recommendation to create the capacity to add the device identifier portion of the UDI of high-risk implantable medical devices to electronic claims transactions./7 This overdue change will help to reduce health risks and costs to the Medicare system, and we joined our colleagues in applauding the committee's recommendation when it was released./8

Today, we write for an update on the status of the October 2019 formal recommendation. Specifically, we request information on when X12 plans to publicly release a final new version of the electronic claims transaction and whether that electronic claims transaction will include the device identifier portion of the UDI of high-risk implantable medical devices. If the new version of the claim transaction will include device identifiers, please provide us with the full details on its use, such as restrictions on when device identifiers can be included in claims and the number of device identifiers permitted per claim. Finally, we also request information on when X12 intends to recommend the adoption of the new version of claim transactions for formal adoption by the Centers for Medicare & Medicaid Services for use in health care.

We would appreciate a response, in writing, no later than May 3, 2021, and request that you expedite the release and implementation of this critical change that will improve patient care.

See signatories and footnotes here: https://www.warren.senate.gov/imo/media/doc/2021.04.19%20Letter%20to%20X12%20on%20Release%20of%20Medicare%20UDI%20Recommendation.pdf