Pascrell, Warren Lead Colleagues Seeking Greater Medicare Patient Safety

Inclusion of device identifying information on claims forms will save lives

WASHINGTON, DC – U.S. Rep. Bill Pascrell, Jr. (D-NJ-09) and U.S. Sen. Elizabeth Warren (D-MA) today led colleagues in both chambers in calling on the National Committee on Vital Health and Statistics (NCVHS) to support the inclusion of unique device identifier (UDI) information on Medicare claims forms in its recommendations to the Department of Health and Human Services (HHS). If that ultimately occurs, the change could preserve countless lives and save the government billions of dollars.

The letter is signed by Pascrell, Sens. Warren and Charles Grassley (R-IA), and Reps. Lloyd Doggett (D-TX-35) and Brian Fitzpatrick (R-PA-01).

For years, Rep. Pascrell has led congressional efforts demanding the inclusion of UDI on claims forms. 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.

“The inclusion of 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,” the lawmakers write. “We have extensively advocated for UDI information to be collected in both electronic health records and on claims transactions to help reduce health risks and costs to the Medicare system.”

Their letter follows the American National Standards Institute’s Accredited Standards Committee’s (X12) June 2022 formal recommendation to NCVHS to include the UDI portion of a medical device’s unique device identifier on Medicare claims forms. In its recommendation to NCVHS, X12 stressed that “(i)ncluding device identifier information on claims transactions greatly improves the industry’s ability to identify risks and reach patients who may be affected by device failures,” “improves patient outcomes and reduces patient health risks and enhances tracking and reporting related to specific devices,” and “also (saves) taxpayer funds.”

According to the U.S. Food and Drug Administration’s (FDA) Compliance Dashboard, the FDA recalled more than 2,600 devices in FY2021. Unfortunately, in many cases the recall of devices occurs only after the devices have been implanted in or used by hundreds or thousands of patients, resulting in extensive revision surgeries, severe pain or other medical problems, and in some cases, even death.

For example, hundreds of thousands of patients received implantable cardiac defibrillators that could malfunction and lead to major health problems and death. Given the program’s patient population, these product failures bear a significant financial toll on Medicare. Researchers estimate that problems with a single brand of a cardiac implant cost Medicare $287 million over five years and may have even reached as much as $1.2 billion. A 2017 investigation by the Office of Inspector General at the U.S. 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.

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.

In November 2019, Pascrell, Warren, and Grassley sent letters in support of recommendations that the device identifier portion of UDIs be added to the standard information on electronic health insurance claims forms. Their letters were sent to the HHS, DMS and the X12 Committee.

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