U.S. Representative Bill Pascrell, Jr. (D-NJ-09), a member of the House Ways and Means Subcommittee on Health, announced progress in his efforts at improving patient care by monitoring the quality and safety of medical devices with unique device identifiers (UDI).

“After my continued urging and a positive meeting yesterday with Acting Center for Medicare and Medicaid Services Administrator Andy Slavitt, Food and Drug Administration Commissioner Robert Califf, and Democratic Leader Nancy Pelosi regarding inclusion of UDI in claims, I am extremely pleased that CMS and FDA will now be jointly advocating for this policy as part of the next claims form update," said Rep. Pascrell. "UDI in claims can improve the safety and quality of patients’ health care, as well as provide important program integrity benefits for Medicare. I want to thank Leader Pelosi for her advocacy on this important issue and I look forward to working together with all stakeholders to get this important reform across the finish line.”

Rep. Pascrell has been working with various stakeholders for years to incorporate UDIs for medical implant devices into Medicare claims. During the meeting yesterday, Rep. Pascrell was informed of a letter sent by Slavitt and Califf to the Accredited Standards Committee X12 in support of UDI inclusion on the next claims form update. (LETTER_FDA CMS Beatty Letter on UDI in Claims 7.13.16.pdf.) X12 is a multi-stakeholder administrative committee that plays an important role in developing and updating the health insurance claims form. This development is particularly noteworthy because CMS has opposed the inclusion of UDI in claims in the past.

In 2013 and 2014 alone, the FDA recalled more than 120 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.