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Grassley, Bipartisan Members of Congress Send Letter Advocating for Unique Device Identifiers Information to be Added to Electronic Health Insurance Claims Forms

December 03,2019

WASHINGTON – Senate Finance
Committee Chairman Chuck Grassley (R-Iowa) joined Sen. Elizabeth Warren
(D-Mass.), Reps. Lloyd Doggett (D-Texas), Brian Fitzpatrick (R-Pa.) and Bill
Pascrell (D-N.J.) in sending letters in support of
recommendations that the device identifier portion of unique device identifiers
(UDIs) be added to the standard information on electronic health insurance
claims forms. Their letters were sent to Department of Health and Human
Services (HHS), the Center for Medicare and Medicaid Services (CMS) and the X12
Committee, which sets industry standards for commonly used medical forms and
recently issued a recommendation to include the device identifier portion of
UDIs on electronic claims transactions.
are serial numbers that are used to identify specific types of medical devices,
including implantable devices like pacemakers or artificial joints. 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-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. In addition, while the FDA uses post-market
surveillance to monitor problems with drugs and vaccines, it is limited in its
efforts to monitor medical devices because UDIs are not tracked on claims
these reasons, patient advocates and lawmakers like Grassley and Warren have
long advocated for adding UDIs to the
standard information on insurance claims forms. Such forms are a key source of
data because they track nearly every interaction a patient has with the health
care system, including with different providers and insurers.

overdue change will help to reduce health risks and costs to the Medicare
system. Including this information in claims transactions will enhance
post-market surveillance of potential faulty devices and streamline the process
of identifying affected patients when problems arise,” the lawmakers wrote.

the X12 Committee’s recommendation to include the device identifier portion of
UDIs on electronic claims transactions is finalized, this change would also
need to be adopted by CMS via rulemaking. In these letters, the lawmakers urged
X12 to finalize the recommendation and CMS to adopt the recommendation and
implement the change. The public comment period for the X12 recommendation ends
November 30, 2019.

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