New CMS and FDA Heads Urged to Back Effort to Add UDI to Claims Forms

Posted in Regulatory and Compliance by MarieThibault on May 17, 2017

A years-long initiative to add unique device identifiers to insurance claims forms continues, with supporters asking the new directors of CMS and FDA to rally behind the cause.

Marie Thibault

A group of healthcare systems, payers, medical societies, and medical product companies have asked the new leaders of CMS and FDA to support a push to add unique device identifiers (UDIs) to insurance claims forms.

In a letter addressed to CMS Administrator Seema Verma, MPH and FDA Commissioner Scott Gottlieb, MD, organizations including Cook Group, Aetna, The Pew Charitable Trusts, and the American College of Cardiology asked the leaders to uphold FDA and CMS support for the initiative. UDIs are codes used to label medical devices, making the devices distinguishable once they are distributed and in use. The move to add the identifiers to claims forms has enjoyed public support from many influential stakeholders since 2014. Advocates believe the addition of UDIs could improve patient safety and speed detection of defective medical devices, among other potential benefits.

In the May 17 letter, the organizations described the addition of UDIs to claims forms as “a policy change that would equip patients, clinicians and researchers with better data to prevent harm and reduce cost.”

In July 2016, then-FDA head Robert Califf, MD, MACC and CDRH director Jeffrey Shuren, MD, wrote a JAMA editorial describing UDI information as part of a National Evaluation System for health Technology (NEST). Later that month, support for UDI on claims forms came from HHS and CMS. In fall 2016, an Office of Inspector General for HHS (HHS OIG) review found that costs from seven recalled or defective devices added up to $1.5 billion in Medicare payments and $140 million in copayments and deductibles. The HHS OIG also recommended CMS add UDIs to claims forms.

While the initiative has many supporters, there have been concerns about the costs and operational burdens. In addition, medical device industry group AdvaMed said earlier this year that it believes adding UDIs to claims forms “could generate inaccurate and misleading conclusions about the performance and value of specific technologies.”

In February 2017, the Accredited Standards Committee (ASC) X12—the group responsible for updating claims forms—put out a recommendation that the identifiers be required on insurance claims forms when high-risk medical devices are implanted or removed. That recommendation is in a comment period until June 1.

As the supporters laid out in their letter, the rest of the process to incorporate identifiers on claims forms will still take years. The ASC X12 committee will need to issue a final recommendation before CMS puts out the regulations implementing the addition. Insurers and hospitals would then have about two years to put the changes in place, meaning real-world impact wouldn’t come until 2021.

“As this process continues—including through eventual rulemaking by CMS—your agencies have a critical role in advancing patient safety and reducing costs through the addition of device identifiers to claims,” the authors wrote in the letter. “We urge you to continue advancing this critical policy that has support across the healthcare system.”

Marie Thibault is the managing editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @MedTechMarie.

[Image courtesy of IAMNEE/FREEDIGITALPHOTOS.NET]