November 27, 2019
Including UDIs Would Help Practitioners Track Certain Patient Care, Improve Safety in the Event of a Medical Device Recall, and Reduce Costs
In Bipartisan Letter, Warren, Grassley, Doggett, Fitzpatrick, & Pascrell Advocate for Unique Device Identifiers (UDI) Information to be Added to Electronic Health Insurance Claims Forms
Including UDIs Would Help Practitioners Track Certain Patient Care, Improve Safety in the Event of a Medical Device Recall, and Reduce Costs
Washington, DC –
United States Senator Elizabeth Warren (D-Mass.), member of the Senate Committee
on Health, Education, Labor, and Pensions, and Senator Chuck Grassley (R-Iowa),
Chairman of the Senate Committee on Finance, along with Representatives Lloyd Doggett
(D-TX), Chairman of the House Ways and Means Health Subcommittee, Brian Fitzpatrick
(R-PA), and Bill Pascrell (D-N.J.), yesterday sent 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.
UDIs 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 forms.
For these reasons, patient advocates and lawmakers like
Senators Warren and Grassley 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.
“This overdue change will help to reduce health risks and
costs to the Medicare system,” wrote the
lawmakers in their letters. “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.”
If 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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