Chris Newmarker

March 11, 2016

5 Min Read
Senators Push CMS to Get UDIs onto Insurance Forms

Sens. Charles Grassley and Elizabeth Warren are urging CMS to cooperate more when it comes to including unique device identifiers on claims forms. They say the identifiers would not only improve patient safety, but also save Medicare money.

Elizabeth Warren and Charles Grassley UDIs

Sens. Elizabeth Warren and Charles Grassley

Chris Newmarker

Two U.S. senators, one a Republican and the other a Democrat, are together urging CMS to cooperate more on getting unique device identifiers onto insurance forms. Sen. Charles Grassley, R-IA, and Sen. Elizabeth Warren, D-MA, say including unique device identifiers on claims forms would not only improve patient safety but also save Medicare a significant amount of money.

"Although the next version of the claims form is not scheduled to be implemented until approximately 2021, the window to make changes is rapidly closing. Given the importance of this issue, we hope you will insure that CMS works collaboratively with FDA and other stakeholders to ensure that the next update of the claims forms will incorporate UDIs," Grassley and Warren said in a letter sent over the past week to the heads of HHS, FDA, and CMS.

Warren and Grassley noted that Congress in 2007 required FDA to create a UDI system, and in 2012 required that the Sentinel Initiative database, which primarily uses claims data to evaluate the safety of drugs and biologics, be expanded to medical devices.

The U.S. Centers for Medicare & Medicaid Services (CMS), however, has been reportedly pushing back, saying that including medical device UDIs on payments from hospitals would present too many technical hurdles and costs.

"CMS is the only relevant agency in opposition. Including the unique device identifier would be helpful for patients and also help ensure proper Medicare billing and payment for devices among hospitals, device manufacturers, and CMS," Grassley told Qmed through a spokesperson.

In their letter to HHS secretary Sylvia Matthews Burwell, CMS acting administrator Andy Slavitt, and FDA commissioner Robert Califf, Grassley and Warren included a letter they received from the HHS Office of Inspector General that estimated that Medicare, and by extension taxpayers, have billions of dollars on fixing and monitoring problems caused by defective medical devices--problems that could have been caught sooner with UDIs.

In but one example, Medronic's Sprint Fidelis defibrillator lead was recalled in October 2007 after 268,000 of them had already been implanted. For months, Medtronic and FDA lacked the data they needed to properly gauge the danger. That one recall is estimated to have cost Medicare $1 billion, according to the HHS Inspector General.

"Inclusion of UDI in claims would allow for faster identification of poorly performing and recalled devices, and ensure that hospitals, device manufacturers, and CMS are all receiving proper reimbursement," Grassley and Warren said.

The two senators latest lobbying of CMS comes only two months after a Senate committee report suggested that use of such unique identifiers could have helped prevent last year's deadly superbug outbreaks related to a special type of endoscope called a duodenoscope.

Major scope maker Olympus for years failed to disclose the extent of problems to FDA and the U.S. public, even as it issued "important safety advice" in Europe in 2013, and another European safety alert about tainted scopes in 2014, according to the report, which was issued from the office of Sen. Patty Murray, D-WA, the top Democrat on the Senate Health, Education, Labor, and Pensions Committee.

The report out of Murray's office called for legislation to require and promote unique device identifiers (UDIs) in insurance claims, electronic health records, and device registries for faster FDA identification of problems.

Interestingly enough, the original idea was that UDIs on claims forms would to improve billing accuracy, but it has become increasingly apparent that they would enable safety tracking of both implanted medical devices and devices reprocessed between use, says Madris Tomes, a former FDA public health analyst who last year founded York, PA-based Device Events and its Web-based tool that searches medical device postmarket surveillance data.

"In order for UDI to be the most meaningful it can be, there are strong reliances on CMS," Tomes says. "The FDA can only mandate that a UDI be applied to a device. In order for implementation to be a true success, that UDI needs to be used in adverse event reporting, in electronic health records, and in claims 

Senators to CMS: Get UDIs onto Insurance Forms

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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