Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) sent a letter
to the Accredited Standards Committee (X12) urging them to finalize their
recommendation that Medicare claims forms include the device identifier portion
of a medical device’s unique device identifier (UDI). UDI’s are serial numbers used
to identify specific types of medical devices, including implantable devices
like pacemakers or artificial joints and provide critical information to
The bipartisan letter was addressed to X12 as they set
industry standards for commonly used medical forms.
Grassley and Warren’s letter to X12 follows
the senators’ November 2019 letters to
the Department of Health and Human Services (HHS), the Center for Medicare and
Medicaid Services (CMS) and the X12 Committee in support of this
recommendation, which the X12 released in October 2019
Currently, when a device fails or is
recalled, it can be difficult to identify which patients will be affected,
leading to risks of complications and increased costs to the health care
system. Medical device failures can cause serious health problems and financial
costs: a 2017 HHS-Office of Inspector General (OIG) report found
that recalls or premature failures of
just seven faulty cardiac devices resulted in $1.5 billion in Medicare payments
to providers and $140 million in out-of-pocket costs to beneficiaries.
“Including device identifiers on claims
transactions would greatly improve the health system’s ability to identify
risks and reach patients who may be affected by device failures. Researchers
can rely on claims data to track patients’ interactions with the health system,
even when the patient changes providers. As a result, the data can be used to
establish population-level correlations between a particular treatment and a
long-term outcome or side effect,” the senators wrote.
Grassley and Warren have extensively
advocated for device identifier information to be collected in both electronic
health records and on claims transactions since 2014:
Prior to sending
letters of support to HHS,
CMS, and X12 in November 2019, the senators sent a letter
to the Food and Drug
Administration (FDA) to reiterate the importance of including medical device
identifiers on the updated Medicare claim form and to urge the agency to
maintain its support for this change in June 2018.
In November 2017, Senators Warren
and Grassley pressed
CMS to clarify its position on the
inclusion of medical devices' device identifiers on Medicare claim forms.
In October 2017, both senators issued a statement
in support of HHS-OIG’s
recommendation that the CMS work to add device identifiers to Medicare claims
in order to better track faulty devices.
In February 2017, X12 released a
draft update to health insurance claims forms that includes device identifiers.
The senators commented
on the proposal.
In August 2016, Senators Warren and
X12 about the steps it was taking to
include medical devices' UDI on health insurance claim forms, and in October
2016, following the preliminary results of the HHS OIG ongoing review, the
senators again urged
CMS and X12 to include device
identifiers on health insurance claim forms.
In March 2016, Senators Warren and
Grassley wrote to HHS, CMS, and FDA
inquiring about the
progress that had been made in adding the UDI of medical devices to health
insurance claim forms.
In December of 2014, Senators
Warren and Grassley wrote to CMS
expressing support for the
inclusion of UDIs in claims forms and pressed CMS to work with other
stakeholders on the benefits of a UDI system. In August 2015, the senators
wrote another letter to the HHS-OIG requesting information
about his review of the
cost to Medicare incurred by defective medical devices and the challenges of
obtaining this data absent a way to track medical devices through claims forms.
Full text of the letter can be found HERE