Here are five highlights:
1. While many FDA officials and legislators have endorsed medical device ID numbers, this marks the first time Medicare has supported the move.
2. The ID numbers would allow the FDA to readily identify malfunctioning devices and then order a recall if deemed necessary.
3. CMS Acting Administrator, Andrew M. Slavitt and FDA Commissioner Robert M. Califf said unique identifiers would promote patient safety, with the FDA supporting the move for the last four years.
4. While Congress instructed the FDA to develop a device-identifier system in 2007, device-safety experts say billing records need to use the identifiers for the system to be effective. However, AdvaMed, a medical-device industry group, said although it supports the use of IDs, using the IDs in the billing system is challenging and impractical.
5. Advocates for using ID numbers in the billing process claim the identifiers will help providers not only track devices, but know where the devices were implanted. The numbers will also help medical professionals estimate device failure and malfunction rates.
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