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Regulatory News | 03 February 2017 | By Michael Mezher
The group tasked with developing the standards for insurance claims forms on Wednesday recommended including unique device identifiers (UDI) on claims forms.
Specifically, the Accredited Standards Committee X12 recommended that the device identifier portion of a UDI be included when high-risk devices are implanted or removed "due to safety concerns about premature failure."
The recommendations are now undergoing a three-month consultation ending on 2 May 2017. Following the consultation, the recommendations will go through a review before the revised standard is sent to the Centers for Medicare and Medicaid Services (CMS) for adoption.
For supporters of including UDI on insurance claims forms, the move was a positive sign. Because these forms are revised infrequently (the last version was released in 2012), proponents were concerned that if a change was not made, the upcoming revision could delay the inclusion of UDIs in claims forms by a decade.
A UDI is composed of a device identifier (DI), which identifies the device labeler and the specific version or model of the device, and one or more production identifiers (PI), which identifies additional information such as the lot, batch, serial number, expiration date and date of manufacture.
Congress first required the US Food and Drug Administration (FDA) to implement a system for UDIs in the 2007 Food and Drug Administration Amendments Act. The act also required FDA to develop a system, now known as Sentinel, for active postmarket safety monitoring for drugs and biologics, which was later expanded to include medical devices.
In February 2016, FDA officials announced that Sentinel had moved out of its pilot phase, but noted that UDI integration into insurance claims forms and electronic health records (EHRs) remains a major challenge.
Last July, then-FDA Commissioner Robert Califf and Acting CMS Administer Andrew Slavitt wrote to the X12 committee, urging the group to incorporate UDIs in the next version of the claims forms.
"We believe that a new change request resulting in a technical solution that supports adding the [device identifier] to health care claims for implantable devices would improve device oversight and monitoring and support more robust research," Califf and Slavitt wrote.
Now, proponents of adding UDI to insurance claims forms, including Sens. Elizabeth Warren (D-MA), Chuck Grassley (R-IA) and the Pew Charitable Trusts, are applauding the X12 committee's recommendations.
"Adding device identifier information to insurance claims forms will make a dramatic difference in our ability to track down faulty medical devices before they can hurt people," Warren said.
Ben Moscovitch, manager of health information technology at Pew also praised the move, saying "If the recommendation is fully implemented, the resulting data would help the [FDA], clinicians, hospitals, and patients better understand the long-term safety of artificial hips, cardiac stents, and other life-changing medical implants."
However, the Advanced Medical Technology Association (AdvaMed), which has long resisted such efforts, denounced the move, saying it plans to submit comments to the X12 committee.
"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. Further, implementing this requirement represents an unnecessary new regulatory burden on providers," said Don May, executive vice president of payment and healthcare delivery policy at AdvaMed.
Tags: UDI, Unique Device Identifier, X12, Accredited Standards Committee, Claims Forms