CMS may reverse agency support on unique device identifier requirements

While the agency finally showed signs of support for adding UDI to Medicare claims forms in 2016, a letter from CMS Administrator Seema Verma suggests that it may not happen.
By Jessica Davis
01:25 PM
unique device identifiers in Medicare claims forms

A U.S. Department of Health and Human Services Office of the Inspector General report released Monday recommends partial adoption of unique device identifiers in the next version of Medicare claims forms.

UDI would provide trackable data on Medicare claims forms to help the health sector more effectively identify dangerous devices and improve outcome evaluations.

However, in a letter affixed to the OIG report, CMS Administrator Seema Verma said the agency is still considering this requirement as the policy “would impose burden on physicians unnecessarily.”

The report found similar analysis to an October 2016 report, which estimated Medicare spent over $1.5 billion to replace seven faulty cardiac devices. The report authors said that these flaws would have been found earlier had the UDI policy been in place.

“Lack of information on the claim forms prevents CMS from being able to fully understand and address the Medicare costs related to recalled or prematurely failed medical devices,” the authors wrote. And it “impedes the ability of FDA and CMS to identify poorly performing devices as early as possible. This diminishes device recipients’ chances of receiving timely follow-up care.”

“Although not improper payments, the substantial costs incurred by Medicare and the liabilities incurred by its beneficiaries to replace recalled or prematurely failed medical devices are a significant concern,” the authors continued.

Proponents of adding UDI to claims forms say it will make a big difference in tracking down faulty devices, such as those brought to light in the last year from both Siemens and Abbott (formerly St. Jude).

However, it will require a massive software and technology conversion to make it happen. And its opponents feel the datasets will be far too complex to be properly analyzed.

CMS finally began to support the move for UDI in 2016, although Verma now appears to still be mulling over the idea. But the clock is ticking, as UDI must be added to the form by the time of rollout in 2021 or there won’t be another opportunity for another 10 years.

Twitter: @JessieFDavis
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