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Pascrell Hails Medical Device Decision to Grow Patient Safety

Following repeated Pascrell calls for action, decision to include medical device identification on claims forms a victory for Americans

U.S. Rep. Bill Pascrell, Jr. (D-NJ-09), a member of the House Ways and Means Committee, today celebrated new action by the Accredited Standards Committee X12 moving the nation one step closer to including Unique Device Identifiers (UDI) on medical claims forms. The panel formally recommended the change to the National Committee on Vital and Health Statistics (NCVHS), a Department of Health and Human Services advisory body. The Center for Medicare and Medicaid Services (CMS) will then need to add UDIs to Medicare claims forms through the rulemaking process.

Rep. Pascrell has led congressional efforts demanding the inclusion of UDI on claims forms since 2015. Pascrell has been working with various stakeholders for years to incorporate UDIs for medical devices into health insurance claims. X12 is a multi-stakeholder administrative committee that plays an important role in developing and updating the health insurance claims form.

“Adding a field for a unique medical device identifier on Medicare claims forms is a watershed move for patient safety that is a long time coming," said Rep. Pascrell, who has been working for years to have UDI information placed on claims forms. “Patients, hospitals, providers, and the entire Medicare system will be better for it when this change is fully enacted. We have worked towards this reforms for years and it will be a milestone to improve quality, bolster care, give better value, and save lives. Technology is advancing at a tremendous rate - let’s use it to promote safer medical devices and avoid expensive and dangerous revision surgeries.”

In September 2013, the Food and Drug Administration (FDA) published its final rule requiring that most medical devices distributed in the U.S. carry a Unique Device Identifier. The UDI is a system that assigns distinctive codes to medical devices so they can be adequately identified through their distribution and use. The UDI was conceived as a patient-safety measure. When leveraged appropriately, the UDI can help identify safety concerns with devices more quickly or disprove a suspected problem.

Pascrell has led and joined letters to HHS, CMS, and X12 over the last eight years urging the adoption of UDI in claims. In February 2017, Pascrell praised the draft recommendation by ASC X12 to include the device identifier portion of the UDI on the health insurance claims form for high-risk devices. In July 2021, Pascrell and his colleagues urged HHS Secretary Xavier Beccerra and CMS Administrator Chiquita Brooks-LaSure to commit to including the device identifier portion of a medical device’s unique device identifier in Medicare claims forms. Rep. Pascrell has also advocated for reform in calls and meetings with agency officials, as well as during Ways and Means Committee hearings, amendments, and on the House floor.

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