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Pascrell Applauds Standards Decision for Medical Devices

Decision to include medical device identification on claims forms major victory for patients and hospitals

U.S. Rep. Bill Pascrell, Jr. (D-NJ-09), a member of House Ways and Means Committee, today praised a decision by the Accredited Standards Committee X12 to finally recommend that Unique Device Identifiers (UDI) be included on medical claims forms.

“Adding a field for a unique medical device identifier on the Medicare claims form is a transformative victory for patient safety," said Rep. Pascrell, who has been working for years to have UDI information placed on claims forms. “Patients, hospitals, providers, and the Medicare system will see the benefit of this new policy. After years of effort, today marks another major milestone to improve quality, bolster care, give better value, and save lives.

“Thank you to the medical professionals, policy experts, safety advocates and administration officials who doggedly supported this policy in the face of small-minded opposition. Technology is advancing at a tremendous rate - let’s use it to promote safer medical devices and avoid expensive and dangerous revision surgeries.”

Rep. Pascrell has been working with various stakeholders for years to incorporate UDIs for medical implant devices into health insurance claims. X-12 is a multi-stakeholder administrative committee that plays an important role in developing and updating the health insurance claims form.

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 (UDI). 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.

From 2013 through 2015 alone, the FDA recalled more than 150 medical devices.  However, in many cases, the recall 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. In fact, hundreds of thousands of patients received implantable cardiac defibrillators that could malfunction and lead to 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.

After countless calls and meetings with officials in the Department of Health and Human Services going back to 2015, the Accredited Standards Committee (ASC) X12, which maintains standards for health care claims data, has recommended that UDI be added to claims forms.

Rep. Pascrell has not only held calls and meetings with agency officials, he has also brought up this issue during Ways and Means Committee markups, attempted to have it included in Appropriations bills, drafted a bill requiring that UDI be added the claims forms, sent letters to his then-Majority colleagues on the committee, and sent letters to the Office of Management and Budget. He also praised the recommendation by ASC X12 in February 2017 to include the device identifier portion of the UDI on the health insurance claims form.

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