In what is a significant step for the effort to add unique device identifiers (UDIs) to health insurance claims forms, on February 1 the Accredited Standards Committee (ASC) X12 released its recommendation that UDIs be required on claims forms when high-risk medical devices are implanted or explanted.

While supporters of the effort cheered the committee's recommendations, not everyone, including a major medical device industry group, backs the move.

More specifically, the committee wrote that UDIs should be "required when a high risk implantable device has been implanted and the provider and payer have mutually agreed to or are mandated by state or federal laws/regulation to exchange this information or required when known that a high risk implantable device has been explanted due to safety concerns about premature failure and the provider and payer have mutually agreed to or are mandated by state or federal laws/regulation to exchange this information," according to the recommended text. 

X12 is the standards committee that is responsible for updating claims forms, so its recommendation is noteworthy. Groups pushing for UDIs on claims forms, including The Pew Charitable Trusts, The Society of Thoracic Surgeons, Aetna, Duke Medicine, Intermountain Healthcare, and several more, have lobbied CMS, X12, Congress, and more on the issue. The effort is supported by  Senators Elizabeth Warren (D-MA) and Charles Grassley (R-IA), among other members of Congress. In July 2016, the initiative also gained backing from CMS.

In a statement, Ben Moscovitch, who manages health information technology at The Pew Charitable Trusts, said, "If the recommendation is fully implemented, the resulting data would help the U.S. Food and Drug Administration, clinicians, hospitals, and patients better understand the long-term safety of artificial hips, cardiac stents, and other life-changing medical implants. Millions of devices are implanted in the United States each year, and while failures are rare, they can lead to serious health risks and even death. They can also present enormous financial costs for patients and taxpayers."

Supporters have also suggested that having UDIs on claims forms could have prevented or reduced the impact of the infamous duodenoscope-associated infectious outbreak.

But not everyone in the healthcare industry is advocating for UDIs on claim forms. Don May, executive vice president, payment and health care delivery policy at AdvaMed, said in a statement, "AdvaMed continues to oppose the addition of UDI information to the claims forms . . . we are concerned that a complex dataset that combines UDIs and hospital and physician claims information would be difficult to analyze appropriately and could generate inaccurate and misleading conclusions about the performance and value of specific technologies. This could lead patients and physicians to make ill-informed decisions about the continued use of an important medical device." May continued, "Further, implementing this requirement represents an unnecessary new regulatory burden on providers."

What happens next?  The X12 committee's recommendation is one hurdle cleared for supporters, but Moscovitch pointed out that the recommendation still needs to be finalized, reviewed by other advisory committees, and then turned over to CMS to become final rules. "That process could take a year or more," he said, adding that the inclusion "may not be fully implemented until about 2021." This kind of change doesn't come often, either. Moscovitch said that if this process isn't continued now, the next opportunity may not come for another decade.

The review period for the X12 recommendation closes on May 2, 2017.

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