Dive Brief:

• Organizations including The Pew Charitable Trusts, the Society of Thoracic Surgeons, the Learning UDI Community and individual health systems are urging a standards committee that oversees development of health insurance claims forms to move forward with a plan to include medical device identifiers on the documents.
• Such a policy change would improve patient safety and reduce healthcare costs by enabling better tracking of device implants, the groups said in comments to the Accredited Standards Committee X12.
• The ACS X12 standards body is gathering public comments on the proposal to add unique device identifiers (UDIs) to the claims form until Nov. 30, ahead of a forum planned to discuss the issue.

Dive Insight:

FDA, in a 2013 final rule, made it a requirement that most medical devices distributed in the United States carry a UDI as a patient safety measure. Current health insurance claims forms, however, include only the procedures performed and a field for reporting device failures and recalls. The standard form does not include information on the brand or model of an implantable device.

A 2016 data analysis by The Pew Charitable Trusts found that seven cardiac device implants that failed or were recalled cost Medicare $1.5 billion and patients $140 million in out of pocket costs. The group concluded better tracking of medical devices through Medicare claims could help detect device failures more quickly to minimize harm to patients and control costs.

That year, the HHS Office of Inspector General (OIG) told CMS that the lack of medical device information on patient claims forms impedes the tracking of Medicare costs associated with replacing recalled or defective devices. OIG recommended CMS collaborate with ASC X12 to include device identifier information on the next version of the form.

In October, ACS X12 formally recommended that a field be added for UDIs on the form.

"X12's proposal to add device identifiers to claims is a critical next step to using real world evidence to assess the safety and performance of artificial joints, cardiac devices, and other medical implants," Ben Moscovitch, project director for health information technology at The Pew Charitable Trusts, told MedTech Dive in an email.

In its public comments to X12, Pew said adding device identifiers to claims forms would allow FDA programs such as the Sentinel Initiative and the National Evaluation System for health Technology to more readily assess the performance of different implant brands and models. X12 should finalize its proposal to add device identifiers to claims, Pew said.

The Society of Thoracic Surgeons, in its comments, said inclusion of device identifiers in claims forms has support across the healthcare system, including from clinical societies, hospitals, health plans, registries, patient groups, public health organizations and members of Congress.

The Learning UDI Community, comprised of healthcare providers, physicians, nurses, manufacturers, distributors, software application providers and other healthcare stakeholders said it strongly supports the inclusion of a field on the form for providing the UDI.

"This is a significant step forward in advancing patient safety by linking devices to patients and allowing the study of post procedure outcomes. The ability for researchers to study real world outcomes will improve innovation and lead to better patient outcomes at lower costs," the group said.