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Therefore, after consideration of the public comment we received and our review of the device pass-through application, we are not approving the Axoguard HA+ Nerve Protector TM for transitional pass-through payment status for CY 2026 because the technology does not meet the substantial clinical improvement criterion at 419.66(c)(2)

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16 This is one of the reasons generics have become 90 percent of all prescriptions in the United States and are cheaper than generics in other developed countries