- Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) are calling on federal regulators to include implant IDs on Medicare claims forms, saying this could save taxpayers billions of dollars.
- The senators cite a letter from the HHS Office of Inspector General noting that recalls of defective devices have led to numerous claims for monitoring, replacement, and follow-up care.
- Beneficiaries implanted with defective devices face possible adverse health effects as well as unnecessary expenses, the letter adds.
The Food and Drug Amendments Act of 2007 called for creation of unique device identifiers (UDIs) that would enable the tracking of each medical device. But to fully reap the benefits of UDI, the identifiers need to be incorporated in electronic health records, Grassley and Warren said in a March 8 letter to HHS Secretary Sylvia Burwell, CMS Acting Administrator Andy Slavitt and FDA Commissioner Robert Califf.
To date, CMS has opposed adding UDI to Medicare claims forms because of the technological challenges, the senators said.
“Given the importance of this issue, we hope you will ensure that CMS works collaboratively with the FDA and other stakeholders to ensure that the next update of the claims form will incorporate UDIs,” the senators wrote.
According to the inspector general, there have been more than 200 recalls of cardiac devices alone since 2010. Numerous recalls of orthopedic devices have also pushed up Medicare costs, the inspector general said. He cited an October 2007 recall of Medtronic’s Sprint Fidelis defibrillator lead, which affected 268,000 implants and cost Medicare more than $1 billion.